*For IACUC Use Only: IACUC No.: \_\_\_\_\_\_\_\_\_\_\_\_\_ Date of
Approval: \_\_\_\_\_\_\_\_\_\_*

#### **(Version 3.04 must be used starting on 8/1/2007)**

Check all that apply:

Maj. Surv. Surgery Primates Cat. E studies Haz. Agents Dogs, cats or
pigs

**[Animal Component of Research Protocol]{.smallcaps}** **(ACORP)**

##### Version 3.04

**Note:** Use a separate form for each species. DO NOT include
individual appendices if they are not relevant to the protocol being
described. To check boxes, right click, choose properties, then click to
check the box. [Define all abbreviations the first time they are
used.]{.underline} To add a row to a table, click inside one of the
existing table cells, then select Table, Insert, Rows from the main menu
of the program.

A. **ACORP Status.** Complete items A.1- A.8 below; then proceed to item
B.

1\. Name of Principal Investigator:

2\. VA Station Name and Number:

> 3\. Proposal Title:
>
> 4\. Animal Species covered by this ACORP ([only one]{.underline}):

5\. Funding Source. Indicate the source(s) of funds that will be used to
perform these animal procedures once approved by the VA IACUC:

Department of Veterans Affairs

U. S. Public Health Service (e.g. NIH)

Private or Charitable Foundation. [Identify]{.underline}:

University Departmental Funds. [Identify]{.underline} University and
Department:

Private Company. [Identify]{.underline}:

Other. [Identify]{.underline}:

6\. Is this a new ACORP for a new project?

Yes. Proceed to item 7.

No. Answer A.6.a-d. below.

> a\. Indicate the status of this ACORP below:
>
> This is an unchanged, approved ACORP intended for a new funding
> source.
>
> This is a revised ACORP with a new funding source.
>
> This is a revised ACORP that reflects changes or additional, new
> studies.
>
> This ACORP is submitted as a three-year (3-year) renewal ([see item d.
> below]{.underline}).
>
> Other. [Please specify]{.underline}:
>
> b\. Previous ACORP title:
>
> c\. Previous IACUC approval number (VA and affiliate, if applicable):

d.  If this is a three-year renewal, provide a progress report
    describing work accomplished during the last approval period.
    Include the number of animals used, the objectives that were met and
    how the work proposed in this renewal extends the previous studies.
    If not applicable, go to

> item 7.

7\. Do you plan on performing the animal procedures described in this
form even if you do [not]{.underline} receive intramural VA or
extramural PHS, NSF, or other funding?

Yes.

No.

8\. Indicate the type of animal use:

Research.

Teaching or Training.

Testing.

Sentinel animal use.

Breeding and colony management only; no experimental procedures.

Other. [Please specify]{.underline}:

## Proposal Overview

B. **Lay Description.** Using non-technical (lay) language that a
[senior high school student]{.underline} would understand, briefly
describe how this research project might improve the health of people
and/or other animals. A scientific abstract from a grant proposal is not
acceptable. Once completed, proceed to item

C. **Experimental Design.**

> 1\. Using non-technical (lay) language that a [senior high school
> student]{.underline} would understand, describe the experimental
> design in no more than one or two paragraphs.
>
> 2\. In language scientific colleagues [outside]{.underline} of your
> discipline would understand, describe the experimental design for the
> animal experiments planned, and the sequence of events to reveal what
> happens to the animals. Include all procedures and manipulations, and
> explain why they must be performed. Give your best estimate of how
> many animals will undergo the procedures or manipulations described.
> For complicated experimental designs, a flow chart, diagram, or table
> is strongly recommended to help the IACUC understand what is proposed.
> Do not describe the details of surgical procedures, monoclonal
> antibody production, or behavioral training here. Such details are
> requested later in appendices. Once completed, proceed to item D.
> (Requested animal numbers stated in C.2, Table I, and K should be
> equal in all three sections.)

D. Describe the characteristics of the selected species, strain, stock,
mutant, or breed that justify its use in the proposed study. Consider
such characteristics as body size, species, strain, breed, availability,
data from previous studies, and unique anatomic or physiologic features.
Once completed, proceed to item E.

**[Personnel]{.underline}**

E. Give the names of all research staff expected to work with the
animals in this study. For each person listed, describe their education,
training, and experience with experimental animals in general AND
describe their experience performing the exact procedures in the species
described [in this ACORP]{.underline}. This description must help IACUC
members determine if all animal manipulations, including surgery,
testing, and blood collection, are performed by individuals who are
qualified to accomplish the procedures skillfully and humanely. A
listing of academic degrees alone is [not]{.underline} an adequate
response. (Qualifications to perform euthanasia will be requested in
item U.3. and need not be given here.) Once completed, proceed to item
F.

  ------------------- ------------ ------------------------------------------
  **NAME**            **DEGREE**   **YRS AND TYPE OF RELEVANT EXPERIENCE**

                                   

                                   

                                   

                                   

                                   

                                   
  ------------------- ------------ ------------------------------------------

F. **Mandatory Training**. Each VA Medical Center must ensure that all
personnel involved with animal research receive training to competently
and humanely perform their duties related to animal research. This
mandate extends to IACUC members, veterinarians, veterinary technicians,
husbandry staff, research technicians, investigators, and all others
that perform procedures or manipulations on laboratory animals. [It also
includes investigators responsible for supervising animal research that
they themselves do not perform.]{.underline}

**Prior to approving any protocol, all staff listed in the application
must be adequately trained.** Free web-based training that will meet
this mandate has been developed by the Office of Research & Development
(ORD). ORD web-based training must be utilized on an annual basis to
help demonstrate compliance with federal animal research training
mandates. Education goals for web-based training will be considered met
when personnel are able to pass an exam that covers important topics in
the training.

The PI and all of the staff must comply with the new mandatory training
policy. Please go to
[**[www.citiprogram.org]{.underline}**](http://www.citiprogram.org/).
The first time you log in, create a new user name and password (if you
have previously completed the coursework at the old researchtraining
website, your original username and password should work). Please
"Select Your Institution: Veterans Affairs-\> Ann Arbor, MI -- 506." Our
administrator will then be able to track your progress.

Please identify all the personnel who will work in this research project
(including the PI). Everyone should complete the course "Working with
the VA IACUC". This course is required annually. Everyone should
complete the species-specific course related to this protocol,
"Preparing an Animal Protocol for Research on (species)". This course is
required annually. Everyone performing survival surgery on rodents must
complete the course, "Post Procedure Care of Mice and Rats in Research".

Please print and submit your Certificate of Completion with the ACORP.

a\. Working with the VA IACUC (required annually)

b\. Species -specific courses (required annually)

c\. Post-procedure Care of Rodents (required annually, if applicable)

+------------+----------+------+--------+--------+--------+--------+
| Name       | E-mail   | Ph   | Em     | a\.    | b\.    | c\.    |
|            | address  | one\ | ployer | W      | S      | Po     |
| (Last,     |          | nu   |        | orking | pecies | st-Pro |
| First)     |          | mber | (VA or | with   | -sp    | cedure |
|            |          |      | UM)    | the VA | ecific | Care   |
|            |          |      |        |        | c      | of     |
|            |          |      |        | IACUC\ | ourse\ | Ro     |
|            |          |      |        | (Y     | Y      | dents\ |
|            |          |      |        | es/No) | es/No) | (Yes/  |
|            |          |      |        |        |        | No/NA) |
+------------+----------+------+--------+--------+--------+--------+
|            |          |      |        |        |        |        |
+------------+----------+------+--------+--------+--------+--------+
|            |          |      |        |        |        |        |
+------------+----------+------+--------+--------+--------+--------+
|            |          |      |        |        |        |        |
+------------+----------+------+--------+--------+--------+--------+
|            |          |      |        |        |        |        |
+------------+----------+------+--------+--------+--------+--------+
|            |          |      |        |        |        |        |
+------------+----------+------+--------+--------+--------+--------+
|            |          |      |        |        |        |        |
+------------+----------+------+--------+--------+--------+--------+

\*\*Please notify the IACUC when there is a change in research study
personnel.

Once completed, proceed to item G.

G. **Occupational Safety and Health.**

1\. Have all personnel listed in item E. been enrolled in the
Occupational Health and Safety Program for those with laboratory animal
contact?

Yes. Proceed to item G.2.

No. [If personnel have declined to participate, are enrolled in another
equivalent program, or will enroll before studies commence, so indicate
here and then proceed to item G.2.]{.underline}

2\. Are there any non-routine measures such as special vaccines or
additional health screening techniques that would potentially benefit
research, husbandry, or veterinary staff participating in or supporting
this project? Routine measures included in the Occupational Health and
Safety Program (vaccination for tetanus, rabies, and hepatitis B, and TB
screening) need not be mentioned here.

Yes. [Describe them]{.underline}, then proceed to item H:

No. Proceed to item H.

H. Complete the following table; then proceed to item I.

  --------------- ------------ -------------- -------------- --------------
  Strain, Stock,  Gender       Age/Size       Source         Health
  Mutant, or                                  (Vendor)       Status\*
  Breed                                                      

                                                             
  --------------- ------------ -------------- -------------- --------------

> \*For each strain, stock, mutant, or breed listed, provide information
> about the expected status of the animals:
>
> -For rodents and rabbits, indicate specific-pathogen-free (SPF),
> gnotobiotic (germ-free or defined flora), conventional, feral, or
> other description.
>
> -For dogs, cats, pigs, and other "large animals", indicate
> specific-pathogen-free (SPF), conditioned, conventional, feral, or
> other description.
>
> -For non-human primates, indicate viral status (e.g., herpes B, SIV,
> etc.)
>
> -Also indicate here if animals will be surgically altered by the
> vendor (e.g., ovariectomized rats).
>
> I. Complete the tables below, assigning all requested animals by
> breed/strain/mutant to a USDA category of pain/distress. If you have
> difficulty determining the appropriate category, please contact the
> attending veterinarian or IACUC Chair for assistance. [The same animal
> cannot be assigned to more than one USDA category]{.underline}. If
> several different procedures are planned, the animal should be placed
> in a category based on the most painful/distressful procedure. You are
> required by VA policy to describe planned procedures for the fourth
> and fifth years of a submitted VA grant even though, under PHS policy,
> the IACUC must perform a new review three years after the initial
> approval date. Once completed, proceed to item J. (Requested animal
> numbers stated in C.2, Table I, and K should be equal in all three
> sections.)

  --------------------------- -------- -------- -------- -------- --------
  **[USDA Category                                                
  B]{.underline}:** List by                                       
  year the number of animals                                      
  that will be bred or                                            
  purchased for breeding, but                                     
  not used for experiments.                                       
  This includes breeders,                                         
  young that cannot be used                                       
  because of improper                                             
  genotype or gender, and any                                     
  other animals that [will                                        
  not]{.underline} have any                                       
  research procedures                                             
  performed on them or                                            
  participate in research                                         
  studies. If numbers cannot                                      
  be determined exactly,                                          
  estimate as closely as                                          
  possible. (Note: If tail                                        
  snips are necessary for                                         
  genotyping, this category                                       
  is not appropriate.)                                            

  Breed/Strain/Mutant         Year 1   Year 2   Year 3   Year 4   Year 5

                                                                  

  **[USDA Category                                                
  C]{.underline}:** List, by                                      
  year the number of animals                                      
  that will undergo                                               
  procedures that involve no                                      
  or only very brief pain or                                      
  distress, with no need for                                      
  or use of pain relieving                                        
  drugs. Examples include                                         
  observational studies, most                                     
  intravenous and parenteral                                      
  injections of                                                   
  non-irritating agents, most                                     
  blood collections from                                          
  peripheral vessels, and the                                     
  collection of cells and/or                                      
  tissues from animals                                            
  [after]{.underline}                                             
  euthanasia has been                                             
  performed.                                                      

  Breed/Strain/Mutant         Year 1   Year 2   Year 3   Year 4   Year 5

                                                                  

  **[USDA Category                                                
  D]{.underline}:** List by                                       
  year the number of animals                                      
  that will undergo                                               
  procedures involving                                            
  potential pain or distress                                      
  that is relieved by                                             
  appropriate anesthetics,                                        
  sedatives, or analgesics.                                       
  Examples include major and                                      
  minor surgery performed                                         
  under anesthesia (survival                                      
  or non-survival), tissue or                                     
  organ collections [prior                                        
  to]{.underline} euthanasia,                                     
  painful procedures                                              
  performed under anesthesia                                      
  (such as retro-orbital                                          
  blood collection in                                             
  rodents), prolonged                                             
  restraint accompanied by                                        
  tranquilizers or sedatives,                                     
  and experiments involving                                       
  infectious or other                                             
  hazardous materials in                                          
  animals that have                                               
  provisions for immediate                                        
  euthanasia if they become                                       
  sick to effectively prevent                                     
  pain and/or suffering. If                                       
  an endpoint is used that                                        
  involves significant pain                                       
  or distress, consideration                                      
  should be given to putting                                      
  animals into Category E.                                        

  Breed/Strain/Mutant         Year 1   Year 2   Year 3   Year 4   Year 5

                                                                  

  **[USDA Category                                                
  E:]{.underline}** List, by                                      
  year, the number of animals                                     
  that will undergo                                               
  procedures in which pain or                                     
  stress is NOT relieved with                                     
  the use of anesthetics,                                         
  analgesics, tranquilizers,                                      
  or by euthanasia. Examples                                      
  include studies in which                                        
  animals are allowed to die                                      
  without intervention (e.g.                                      
  LD~50~, mortality as an                                         
  end-point), studies that                                        
  allow endpoints that are                                        
  painful or stressful,                                           
  addictive drug withdrawals                                      
  without treatment, pain                                         
  research, and noxious                                           
  stimulation.                                                    

  Breed/Strain/Mutant         Year 1   Year 2   Year 3   Year 4   Year 5

                                                                  

  **[TOTALS]{.underline}:**                                       
  Bring all totals for each                                       
  year down, by                                                   
  breed/strain/mutant.                                            

  Breed/Strain/Mutant         Year 1   Year 2   Year 3   Year 4   Year 5

                                                                  
  --------------------------- -------- -------- -------- -------- --------

J. **Description of USDA Category D and E procedures**. Are any USDA
Category D or E studies planned?

> No. Proceed to item K.

Yes. Complete items J.1. and J.2.; then proceed to item K.

1\. **List and describe all** **category D** **procedures by** **filling
out the table below**. If no category D studies are proposed, enter
"N/A" and proceed to item J.2. [In the "Procedure" column, enter only a
brief description. Then enter "See Appendix 5 for details."]{.underline}

  ----------------------- ---------------- --------------- ---------------
  Procedure               Frequency of     Person(s) doing Analgesic,
                          monitoring after the monitoring  sedative, or
                          the procedure                    anesthetic
                          and how long                     used, plus
                          animals will be                  dose, route,
                          monitored                        and duration

                                                           

                                                           

                                                           
  ----------------------- ---------------- --------------- ---------------

2\. Each year a report describing and justifying all category E
procedures must be submitted by each facility to the USDA and the VA. If
no category E studies are proposed, enter "N/A" and proceed to item K.
**Otherwise, describe each category E procedure, and justify completely
why pain or distress relief cannot be provided for each procedure.** If
the species is covered by UDSA regulations, your description will be
used in the USDA annual report. [If animals will be allowed to
experience natural death as a result of experimental procedures (e.g.
infectious disease or oncology studies), or an endpoint is used that
allows the animals to experience significant pain or distress, you must
justify why an alternate endpoint (such as weight loss, clinical signs,
tumor size, etc.) prior to death or pain or distress can not be
used.]{.underline} If animals will undergo category D procedures as
well, describe them in item J.1. above.

> K. **Justification for number of animals requested and group sizes.**
> Describe how the estimated number of animals needed for the
> experiments was determined. When appropriate, provide the number and
> type of experimental and control groups in each experiment, the number
> of experiments planned, and the number of animals in each group. The
> ILAR *Guide* states that [whenever possible, the number of animals
> requested should be justified statistically]{.underline}. [A power
> analysis is strongly encouraged to justify group sizes when
> appropriate]{.underline}. Once completed, proceed to item L.
> (Requested animal numbers stated in C.2, Table I, and K should be
> equal in all three sections.)

L. **Laboratory Animal Veterinary Support**. Complete items L.1-L.3,
then proceed to item M.

1\. Give the name of the laboratory animal veterinarian responsible for
providing adequate care to the animals that will be used [and their
institutional affiliation]{.underline}:

> 2\. VA Policy requires that a laboratory animal veterinarian be
> consulted [during the planning stages]{.underline} of any procedure
> involving laboratory animals, before IACUC review. Give the name of
> the laboratory animal veterinarian consulted during the planning of
> procedures involving animals. As an alternative to an actual meeting,
> the veterinarian may perform a pre-review of the ACORP and provide
> comments to the PI so that the ACORP may be revised prior to IACUC
> review:

3\. Give the date of the veterinary consultation (meeting date, or date
written comments were provided by the veterinarian to the PI):

M. **Husbandry.**

1\. Caging needs. To help the animal care staff with caging needs,
please indicate the type of caging that you will need; then go on to
question M.2:

> Gnotobiotic (germ-free and defined flora) isolators
>
> Biohazard or other special hazard containment caging --complete and
> attach Appendix 9 if this section is checked.
>
> Sterile rodent microisolato[r]{.underline} caging, with filtered cage
> top
>
> Non-sterile rodent microisolator caging, with filtered cage top
>
> Standard rodent shoebox caging [with no filter top]{.underline}
>
> Standard non-rodent caging, appropriate for species
>
> Other. [Describe]{.underline}:
>
> 2\. The ILAR *Guide for the Care and Use of Laboratory Animals* states
> that consideration should be given to housing social animals in groups
> whenever possible. Will social animals be housed singly?
>
> Yes. Complete item M.3.
>
> No. Proceed to item M.4.
>
> Not Applicable; the species involved is not a social animal. Proceed
> to item M.4.

3\. Please provide a justification for housing social animals singly;
then proceed to question M.4.

> 4\. The ILAR *Guide for the Care and Use of Laboratory Animals*
> recommends the use of contact bedding (i.e., shoebox or microisolator
> cages) instead of wire mesh floors for housing rodents. Will rodents
> be housed on suspended wire mesh floors or other flooring in which the
> animals do not rest on bedding?
>
> Not applicable; this ACORP does not describe rodent use. Proceed to
> item M.6.
>
> No. All rodents will be housed in shoebox or other caging in which the
> animals rest directly on bedding. Proceed to item M.6.
>
> Yes. Proceed to item M.5.

5\. Why is caging with wire mesh flooring necessary?

> 6\. Indicate the appropriate response below:
>
> This ACORP does not address the use of dogs, primates, or genetically
> engineered or modified (e.g. transgenic/knockout/knockin) animals.
> Proceed to item M.7.
>
> This ACORP addresses the use of dogs. Answer item M.6.a. below, and
> M.6.c if applicable.
>
> This ACORP addresses the use of primates. Answer item M.6.b. below,
> and item M.6.c. if applicable.
>
> This ACORP addresses the use of genetically engineered or modified
> animals. Answer item M.6.c. below.

a\. Is there any scientific justification for excluding the dogs in this
study from the institutional dog exercise plan required by USDA?

> No. Proceed to item M.7.
>
> Yes. [Provide a scientific justification for excluding the
> dogs]{.underline}; then proceed to item M.7:

b\. Is there any scientific justification for excluding the primates
from the institutional primate psychological enrichment plan required by
USDA?

> No. Proceed to item M.7.
>
> Yes. [Provide a scientific justification for excluding the
> primates]{.underline}; then proceed to item M.7.:

c\. Do the genetically engineered or modified animals exhibit any
characteristic clinical signs or abnormal behavior related to their
genotype?

> No. Proceed to item M.7.
>
> Yes. [Describe here]{.underline}, then proceed to item M.7.:
>
> 7\. Will any cannulae, acrylic implants, venous catheters, or other
> similar medical devices be implanted into an animal such that the
> device extends chronically through the skin?
>
> No. Proceed to item N.
>
> Yes. Explain what implantation and wound management measures will be
> taken to minimize the chances of chronic infections around the
> device(s) where they penetrate the skin.

N. **Housing Sites**.

> 1\. Will all animals purchased or managed (breeding or maintenance of
> colony) with VA or VA Foundation funds be housed only in VA
> facilities?
>
> Yes. Proceed to item N.2.
>
> No. Complete and attach ACORP Appendix 1, "Use Of a Non-VA Facility to
> House Animals Purchased with VA or VA Research And Education
> Corporation Funds", then go to item N.2.
>
> 2\. Give the location(s), inside or outside of the animal facility,
> where animals will be housed permanently or temporarily, then proceed
> to item proceed to item O:

O. **Antibody Production.** Will animals be used to produce monoclonal
or polyclonal antibodies, or will existing hybridoma cell lines be
injected into animals to harvest antibody?

> No. Proceed to item P.
>
> Yes. Complete and attach Appendix 2, "Antibody Production;" then
> proceed to item P.

P. **Test Substances.** Will test substances be administered to animals?
For the purposes of this question, test substances are defined as
materials administered to animals. This includes, but is not limited to,
radioisotopes, toxins, antigen, pharmacological agents, infectious
agents, carcinogens or mutagens, biomaterials, prosthetic devices, and
cells, tissues, or body fluids. [(Note: The following substances do not
need to be entered in Appendix 3 unless they are hazardous]{.underline}:
routine pre- or post-operative drugs described in the Surgery Appendix
\[Appendix 5\], antigens, adjuvants, hybridomas described in the
Antibody Production Appendix \[Appendix 2\], and euthanasia agents
entered in item U, Euthanasia.)

> No. Proceed to item Q.
>
> Yes. Complete and attach Appendix 3, "Test Substances;" then proceed
> to item Q.

Q. **Location of procedures.** Complete the table below, indicating
where all non-surgical procedures and manipulations will be performed.
[The IACUC must be aware of all procedures performed outside of the
animal facility]{.underline}. To help the IACUC track the sites of
animal use outside the animal facility, give the location of any
laboratory or other areas outside of the animal facility in which
animals will be manipulated in any way. Be sure to include the sites of
procedures such as radiography, fluoroscopy, computed axial tomography
(CT), or magnetic resonance imaging (MRI) that may be performed outside
the animal facility.

  ----------------------- --------------- -------------------------------
  Non-surgical Procedure  Building and    Method of discreet transport,
                          Room Number     if required through
                                          [non-research]{.underline}
                                          areas (enter N/A if not
                                          applicable)\*

                                          

                                          

                                          
  ----------------------- --------------- -------------------------------

> \*Describe how animals will be transported to and from these sites.
> Transportation must be in accordance with the *Guide*, USDA
> regulations, and PHS policy in climate-controlled vehicles and
> sanitizable transport cages when appropriate. [Such transport must be
> discreet such that hospital staff and patients are not aware of the
> transport, and are not exposed to allergens and/or body fluids from
> the transported animal(s)]{.underline}. Once completed, proceed to
> item R.

R. **Body Fluid, Tissue, and Device Collection.**

> 1\. Will any body fluids, tissues, or devices be collected from
> animals [AFTER]{.underline} euthanasia?
>
> No. Proceed to item R.2.
>
> Yes. [List the fluids, tissues, and/or devices here]{.underline}; then
> proceed to item R.2.:
>
> 2\. Will any body fluids, tissues, or implanted devices or materials
> be collected from animals [BEFORE]{.underline} euthanasia?
>
> No. Proceed to item S.
>
> Yes. Proceed to item R.3.
>
> 3\. Is collection in live animals limited to blood collection
> associated with antibody production?
>
> No. Complete and attach Appendix 4, "Antemortem Specimen Collection."
> Then proceed to item S. If the body fluid, tissues, or devices are
> collected as a surgical procedure, please be sure to also describe
> these collections as part of the surgical protocol in the Appendix 5,
> "Surgery."
>
> Yes. Because blood collection associated with antibody collection is
> already described in Appendix 2, "Antibody Production", DO NOT
> complete Appendix 4, "Antemortem Specimen Collection." Proceed to item
> S.

S. **Surgery.** Will survival or non-survival surgery be performed?

> No. Proceed to item T.
>
> Yes. Complete and attach Appendix 5, "Surgery;" then proceed to item
> T.

T. **Endpoint Criteria.** What specific endpoint criteria will be used
for determining when sick animals, both on and off study, will be
euthanatized or otherwise removed from a study? Examples of appropriate
criteria that should be considered include a weight loss limit as a
percentage of initial or expected body weight, allowable durations of
anorexia, allowable tumor size or total tumor burden expressed as a
percentage of body weight, the presence of health problems refractory to
medical intervention, and severe psychological disturbances. Other
criteria appropriate for the species under consideration should also be
considered. When complete, proceed to item U.:

U. **Euthanasia**. Will animals be euthanatized as part of the planned
studies?

> No. [Describe the final disposition of the animals here]{.underline},
> then proceed to item U.4:
>
> Yes. Complete items U.1. - U.4. below; then proceed to item V.

1\. Describe the exact method of euthanasia for each animal used.
Include the agents used, dose (as applicable), and route of
administration:

2\. Are all euthanasia methods acceptable according to the latest report
of the AVMA Panel on Euthanasia? ([if you are unsure how to answer,
contact your veterinarian or IACUC for guidance]{.underline})

> Yes. Proceed to item R.3.
>
> No. [Justify]{.underline} any method that is not considered
> "acceptable" by the latest report of the AVMA Panel on Euthanasia,
> then proceed to item R.3.:

3\. List the personnel who will perform euthanasia and indicate their
training and experience with the method of euthanasia and the species
involved. If personnel are not yet trained, indicate so and explain how
they will be trained before performing euthanasia themselves.

4\. If the animal care staff find an animal dead, how should the carcass
be handled (e.g. refrigerated or frozen), and should a member of your
staff be contacted immediately?

V. **Special Procedures.** Are any experimental procedures or special
husbandry procedures planned that are NOT described in the local
standard operating procedures (SOP) manual or elsewhere in this ACORP?
Special procedures can include special restraint practices (including
non-human primate chairing), special animal health monitoring, special
diets, caging, environmental control, exercise, environmental
enrichment, means of identification, use of noxious stimuli, forced
exercise, or behavioral manipulation.

> Yes. Complete and attach Appendix 6, "Special Husbandry and
> Procedures;" then proceed to item W.
>
> No. Proceed to item W.

W. **Consideration of Alternatives and the Prevention of Unnecessary
Duplication.** Complete items W.1 through W.5 below; then proceed to
item X. Keep copies of computer database search results in your files to
demonstrate your compliance with the law if regulatory authorities or
the IACUC should choose to audit your project.

1.  Investigators must consider less painful or less stressful
    alternatives to procedures, and provide assurance that proposed
    research does not unnecessarily duplicate previous work. You should
    perform one or more database searches to meet these mandates unless
    compelling justifications can be made without doing so. Complete the
    table below for each database search you conduct to answer items W.2
    through W.5 below. [You must provide complete information in the
    first four columns of the table to comply with USDA Policy
    #12]{.underline}.

2.  Performing and documenting an effective search for alternatives,
    including selection of appropriate keywords and databases, can be
    challenging. In general, search strategies focused on the research
    topic of interest are not sufficient. Some suggestions are attached
    for designing a search that focuses specifically on potential
    alternatives to the procedures proposed, so as to make the search
    perhaps less tedious and more effective:

**ALTBIB: Bibliography on Alternatives to Animal Testing**. This NIH
website is specifically designed to help you perform database searches
on alternatives. The site is available at
<http://toxnet.nlm.nih.gov/altbib.html>. It helps to properly format
searches in PubMed, provides links to live PubMed searches on selected
animal testing topics. It also displays links to other important sites
on alternatives.

**University of California Center for Animal Alternatives**. This
website offers a variety of pre-formatted searches of multiple
databases. <http://www.vetmed.ucdavis.edu/Animal_Alternatives/main.htm>

**Altweb**. The Altweb website is run by the Johns Hopkins Center for
Alternatives to Animal Testing (CAAT) and provides extensive information
on alternatives. The site includes searches that address pain management
and humane endpoints. <http://altweb.jhsph.edu/>

**Animal Welfare Information Center** (AWIC). AWIC was formed as part of
the USDA by a Congressional mandate to ensure that scientists using
animals could receive help in searching for alternatives. AWIC has
trained professionals that can help you decide which databases are most
appropriate, and which search strategy works best for each database.
AWIC also has extensive literature on alternatives, and strategies to
reduce pain and distress in research animals.
<http://awic.nal.usda.gov/nal_display/index.php?info_center=3&tax_level=1>

**References**

**Short instructions on using the ALTBIB site:**

1\. Type search terms in box (for example, \"tumor and mice\")

2\. Mark the PubMed option under the search box and mark the \"2000-to
present.\"

**Do not mark the \"Animal use alternatives\"**.

3\. Click on search.

4\. The search will be performed by combining the terms added in the box
(e.g. tumor and

mice) with a lengthy list of \"animal alternatives\" terms, thus
facilitating the task of applying appropriate terms.

5\. A new PubMed window will open, displaying the search results.

6\. To document your search, **it is highly recommended that you print
the hits with abstracts to document that you did the search, or save the
hits as an HTML or other file.**

7\. If you receive too many or too few hits, return to ALTBIB to expand
or narrow the search.

8\. There are also very convenient pre-formatted searches (e.g.
\"transgenic mouse model\") near the bottom of the page.

  ---------- ----------- --------- ---------- -- ------------- --------------- ----------- -------------
  Name of    Date search Period    Key words     Indicate                                  
  the        was         (years)   and/or        below for                                 
  database   performed   covered   search        which                                     
  (s)                    by each   strategy      alternative                               
                         search    used          mandate each                              
                                                 search was                                
                                                 conducted by                              
                                                 placing an                                
                                                 "X" in the                                
                                                 proper column                             

                                                 Computer      Use of          Use of less Lack of
                                                 models or *in less-sentient   stressful   unnecessary
                                                 vitro*        species (item   model or    duplication
                                                 techniques    W.3)            methods, or (item W.5)
                                                 (item W.2)                    fewer       
                                                                               animals     
                                                                               (item W.4)  

                                                                                           

                                                                                           

                                                                                           
  ---------- ----------- --------- ---------- -- ------------- --------------- ----------- -------------

> 2\. Could any of the animal procedures described in this ACORP be
> replaced by computer models or *in vitro* techniques? Indicate below
> if such replacement is or is not possible, and [provide a narrative on
> how you came to your conclusion]{.underline}:
>
> 3\. Could a smaller, less sentient mammalian species or a
> non-mammalian species (e.g. fish, invertebrates) substitute for the
> mammals in any of the experiments planned? Indicate below if such
> substitution is or is not possible and [provide a narrative on how you
> came to your conclusion]{.underline}:
>
> 4\. Could a different animal model or different animal procedure that
> involves 1) less distress, pain, or suffering, or 2) fewer animals
> substitute for any proposed animal model or animal procedure planned?
> Indicate below if such replacement is or is not possible, and [provide
> a narrative on how you came to your conclusion]{.underline}:
>
> 5\. Does the proposed research [unnecessarily]{.underline} duplicate
> previous work? Indicate below if the proposed work unnecessarily
> duplicates previous work and [provide a narrative on how you came to
> your conclusion]{.underline}:

X. **Other Regulatory Considerations**. Complete items X.1, X.2, and X.3
below; then proceed to item

> 1\. **Controlled drugs**.
>
> a\. Will all drugs used in animals and classified as controlled
> substances by the DEA be stored in a double-locked cabinet, and be
> accessible only to authorized personnel in accordance with VA policy?
>
> Not applicable- no controlled drugs will be used. Proceed to item X.2.
>
> No. [Please explain here]{.underline}, then go to item X.1.b.:
>
> Yes. Complete item X.1.b.
>
> b\. List the controlled substances that will be used in animals for
> this project here, and include the building and room number where they
> will be stored, then go to item X.1.c.:
>
> c\. To comply with VA pharmacy policies, all controlled substances
> used on VA property must be ordered through and received by the local
> VA pharmacy prior to issue for research use. Will the use of all
> controlled substances comply with these VA pharmacy policies?
>
> No. [Please explain]{.underline}:
>
> Yes. Proceed to item X.2.

2\. Will any human patient procedural areas be used for these animal
studies?

> No. Proceed to item X.3.
>
> Yes. Complete and attach Appendix 7, "Request to Use Patient
> Procedural Area;" then proceed to item X.3.

3\. Will an explosive anesthetic or other explosive agent be used in any
portion of these animal studies?

> No. Proceed to item Y.
>
> Yes. Complete and attach Appendix 8, "Request to Use Explosive Agent;"
> then proceed to item Y.

Y. **Appendices.** Please indicate which of the following Appendices are
completed and attached. [Do not attach blank appendices which are not
applicable to this ACORP]{.underline}. Check with your IACUC to see if
an optional Appendix 9, "Additional Local Information", is required.

> Appendix 1, "Use of a Non-VA Facility to House Animals Purchased with
> VA or VA Research and Education Corporation Funds" (ref item N)
>
> Appendix 2, "Antibody Production" (ref item O)
>
> Appendix 3, "Test Substances" (ref item P)
>
> Appendix 4, "Antemortem Specimen Collection" (ref item R)
>
> Appendix 5, "Surgery" (ref item S)
>
> Appendix 6, "Special Husbandry and Procedures" (ref item V)
>
> Appendix 7, "Request to Use Patient Care Procedural Areas for Animal
> Studies" (ref item X)
>
> Appendix 8, "Request to Use Explosive Agent in the Animal Facility or
> in Animals" (ref item X)
>
> Appendix 9, "Additional Local Information - Biohazard Containment
> Caging"
>
> Laboratory Safety Hazard Assessment Form

Z. **Certifications.** [**Important**: If this ACORP will be submitted
to VA Central Office for Just-In-Time approval prior to receiving VA
funding, the signatures of the Principal Investigator(s), IACUC Chair
and veterinarian must appear below in items Z.1 and Z.3.]{.underline}
*The requirement for an R&D Committee Chair signature and the
requirement that signatures be less then a year old have been dropped*.

> 1\. **Certification by Principal Investigator(s).**
>
> To the best of my knowledge, I certify that the information provided
> in this Animal Component of Research Protocol (ACORP) is complete and
> accurate. I understand that IACUC approval is valid for one year only,
> that approval must be renewed annually, that every third year the
> IACUC must perform a new review of my protocol, and that I might be
> required to complete a newer version of the ACORP and provide
> additional information at the time of the triennial review. [I also
> understand that IACUC approval must be obtained before I:]{.underline}

• Use additional animal species, increase the number of animals used, or
increase the number of procedures performed on individual animals;

• Change procedures in any way that might increase the pain/distress
category in which the animals are placed, or might otherwise be
considered a significant departure from the written protocol;

• Perform additional procedures not described in this ACORP;

• Allow other investigators to use these animals on other protocols, or
use these animals on another of my IACUC-approved protocols.

> I further certify that:

-   [No personnel will perform any animal procedures until they have
    been approved by the IACUC]{.underline}. When new or additional
    personnel become involved in these studies, I will submit their
    qualifications, training, and experience to the IACUC and seek IACUC
    approval before they are involved in animal studies;

-   I will ensure that [all personnel are enrolled in an institutional
    Occupational Health and Safety Program prior to their contact with
    animals, or have declined in writing to participate, if allowed by
    local policy]{.underline};

-   I will provide my [after-hours telephone numbers]{.underline} to the
    animal care staff in case of emergency.

  --------------------------- ---------------------------------- ---------
  Name of Principal           Signature                          Date
  Investigator(s)                                                

                                                                 

                                                                 

                                                                 
  --------------------------- ---------------------------------- ---------

> 2\. **Minority Opinions (For IACUC Use).** IACUC members
> [must]{.underline} be given the opportunity to submit minority
> opinions on this form. Enter any written minority opinions here (or
> attach separate pages labeled "IACUC Minority Opinion"). If there are
> no minority opinions, leave this space blank:
>
> 3\. **Approval Signatures.** To the best of their abilities, the
> undersigned verify that the IACUC has evaluated the care and use of
> the animals described in this ACORP in accordance with the provisions
> of the USDA Animal Welfare Act Regulations and Standards, PHS Policy,
> the *Guide for the Care and Use of Laboratory Animals* and VA Policy,
> and find the use of animals described in this ACORP to be appropriate.

  --------------------------- ---------------------------------- ---------
  Name of Attending           Signature                          Date
  Veterinarian (VMO or VMC)                                      

                                                                 

  Name of IACUC Chair         Signature                          Date

                                                                 
  --------------------------- ---------------------------------- ---------

ACORP Appendix 1

**[Use Of a Non-Va Facility to House Animals Purchased With VA or VA
Research and Education Corporation Funds]{.smallcaps}**

**[Version 3]{.smallcaps}**

1\. Indicate which non-VA facilities will house animals purchased with
VA or VA Research and Education Corporation funds for this project, and
give the current AAALAC International accreditation status for each. Be
sure to consider affiliated institutions and contract facilities that
purchase and house animals on your behalf to make custom antibodies or
other biological products. Consult with your veterinarian or IACUC to
determine which institutions must be entered. USDA policies and PHS
policy clarifications may also be helpful. Once completed, proceed to
item 2.

  ------------------------------------------------ ------------ -----------
  Non-VA Facility Name                             Is this      
                                                   facility     
                                                   accredited   
                                                   by AAALAC?   

                                                   Yes          No\*

                                                                

                                                                

                                                                
  ------------------------------------------------ ------------ -----------

\*According to VHA Handbook 1200.7, "Use of Animals in Research",
paragraph 7.f., all VA animal facilities and affiliate or other animal
facilities that house animals purchased with VA (including VA Research
and Education Corporation) funds [must]{.underline} be accredited by
AAALAC. Under exceptional circumstances, a waiver may be requested in
writing from the CRADO (Chief Research and Development Officer) or
designee through the CVMO (Chief Veterinary Medical Officer). See
Appendix A of VHA Handbook 1200.7 for information on how to contact the
CVMO.

2\. In what non-VA building(s) and room(s) will the animals be housed?

3\. Return to item N.2. on the ACORP.

**ACORP Appendix 2**

**[Antibody Production]{.smallcaps}**

**[Version 3]{.smallcaps}**

1\. **Monoclonal Antibody Production**. Will monoclonal antibodies be
produced in animals or harvested from hybridoma cell lines as part of
this project?

> No. Proceed to item 3.
>
> Yes. Complete item 1.a.

a\. Is antibody harvest limited to existing hybridoma cell lines with no
further immunizations or lymphocyte fusions planned?

> Yes. Proceed to item 2 below.
>
> No. Fill out items 1.b and 1.c below; then proceed to item 2.

b\. Complete the following table regarding the immunization protocol for
the animals prior to lymphocyte harvest for hybridoma creation. For each
antigen for which multiple immunization days will be used, use a
separate row in the table for each immunization day.

+----------+-------+--------+-------+----------+----------+----------+
| #        | # An  | Total  | Ide   | Total    | Divided  | I        |
|  Injecti | tigen | amount | ntity | i        | into how | njection |
| on day ( |       | (mg)   | and   | njection | many     | route    |
| e.g. day |       | and    | v     | volume   | inj      | and      |
|  0, 7, 3 |       | volume | olume | per      | ections? | location |
| 0, etc.) |       | (ml)   | (ml)  | animal   |          | of       |
|          |       | of     | of    | (antigen |          | in       |
|          |       | a      | adj   | plus     |          | jections |
|          |       | ntigen | uvant | a        |          | on body  |
|          |       | in     | inj   | djuvant; |          |          |
|          |       | jected | ected | ml)      |          |          |
+----------+-------+--------+-------+----------+----------+----------+
|          |       |        |       |          |          |          |
+----------+-------+--------+-------+----------+----------+----------+
|          |       |        |       |          |          |          |
+----------+-------+--------+-------+----------+----------+----------+
|          |       |        |       |          |          |          |
+----------+-------+--------+-------+----------+----------+----------+

c\. If feeder cells for supporting hybridoma colony growth will be
collected from animals, describe the exact procedures that will be used
to collect the feeder cells and the number of animals needed for this
purpose:

2\. You must consider alternate research methods that can replace the
use of animals. Will any animals be used to expand hybridoma cell lines
so that antibody can be harvested from ascites fluid?

> No. Proceed to item 2.d.
>
> Yes. Complete items 2.a-2.c below; then proceed to item 2.d.
>
> a\. Explain why *in vitro* cell culture systems for harvesting
> monoclonal antibodies are not adequate to meet the research
> objectives:
>
> b\. Complete the following table:

  ------------- ------------ ----------- ------------ ------------ ------------
  Hybridoma     Number of    Priming     Number and   Volume of    Number of
  cell line     animals used agent and   timing of    injected     abdominal
  designation   for ascites  volume      priming      hybridoma    taps before
                production               injections   cells        euthanasia

                                                                   

                                                                   

                                                                   
  ------------- ------------ ----------- ------------ ------------ ------------

c\. What criteria will be used to determine if animals should be
euthanatized prior to the last planned abdominal tap?

> d\. **Blood collection.** Will survival blood collections be obtained
> from animals following immunization or as a "pre-bleed" prior to
> immunization?
>
> No. Proceed to item 3.
>
> Yes. Complete items 1) and 2) below; then proceed to item 3.
>
> 1\) Complete the following table; include any "pre-bleeds" prior to
> immunizations:

  -------------------- -------------------- ------------- ------------------
  Site of blood        Amount of blood      Number of     Interval between
  collection           collected expressed  blood         collections
                       as volume (ml) and % collections   
                       of body weight                     
                       (assume 1 ml weighs                
                       1 gram)                            

                                                          

                                                          

                                                          
  -------------------- -------------------- ------------- ------------------

2\) Will anesthetics, tranquilizers, or analgesics be used prior to
blood collection?

> No. [Justify the omission of pain-relieving agents]{.underline} here;
> then proceed to item 3:
>
> Yes. [Describe the administration of pain-relieving
> agents]{.underline} including dose (mg/kg), volume (ml), route, and
> frequency/duration here; then proceed to item 3:

3\. **Polyclonal Antibody Production.** Will polyclonal antibodies be
produced in this species of animal as a part of this project?

> No. **[Do not]{.underline}** complete items 3.a.-3.c. Go to item 4
> below.
>
> Yes. Complete items 3.a.-3.c., then go to item 4.

a\. Complete the following table. For each antigen for which multiple
immunization days will be used, use a separate row in the table for each
day:

+----------+------+-------+----------+----------+--------+-----------+
| #        | #    | Total | I        | Total    | D      | Injection |
|  Injecti |  Ant | a     | dentity, | i        | ivided | route,    |
| on day ( | igen | mount | conce    | njection | into   | and       |
| e.g. day |      | (mg)  | ntration | volume   | how    | location  |
|  0, 7, 3 |      | and   | and      | per      | many   | of        |
| 0, etc.) |      | v     | volume   | animal   | injec  | i         |
|          |      | olume | (ml) of  | (antigen | tions? | njections |
|          |      | (ml)  | adjuvant | plus     |        | on body   |
|          |      | of    | injected | a        |        |           |
|          |      | an    |          | djuvant; |        |           |
|          |      | tigen |          | ml)      |        |           |
|          |      | inj   |          |          |        |           |
|          |      | ected |          |          |        |           |
+----------+------+-------+----------+----------+--------+-----------+
|          |      |       |          |          |        |           |
+----------+------+-------+----------+----------+--------+-----------+
|          |      |       |          |          |        |           |
+----------+------+-------+----------+----------+--------+-----------+
|          |      |       |          |          |        |           |
+----------+------+-------+----------+----------+--------+-----------+

b\. [List possible adverse effects in animals that might be seen from
the proposed antigen or adjuvant injections and what measures will be
taken]{.underline} should these adverse effects occur:

> c\. **Blood collection.** Will survival blood collections be obtained
> from animals following immunization or as a "pre-bleed" prior to
> immunization?
>
> No. Proceed to item 4.
>
> Yes. Complete items 1) and 2) below; then proceed to item 4.

1\) Complete the following table; include any "pre-bleeds" prior to
immunizations:

  --------------------- ----------------------- ------------- ----------------
  Site of blood         Amount of blood         Number of     Interval between
  collection            collected expressed as  blood         collections
                        volume (ml) and % of    collections   
                        body weight (assume 1                 
                        ml weighs 1 gram)                     

                                                              

                                                              

                                                              
  --------------------- ----------------------- ------------- ----------------

2\) Will anesthetics, tranquilizers, or analgesics be used prior to
blood collection?

> No. [Justify the omission of pain-relieving agents]{.underline} here;
> then proceed to item 4:
>
> Yes. [Describe the administration of pain-relieving
> agents]{.underline} including dose (mg/kg), volume (ml), route, and
> frequency/duration here; then proceed to item 4:

4\. **Terminal blood collection.** Will animals used for antibody
production be exsanguinated as a method of euthanasia?

> No. Go to item 5.
>
> Yes. Complete items 4.a, b., and c. below, then go to item 5.

a\. Describe the method of exsanguinations:

b\. Will anesthetics, tranquilizers, or analgesics be used prior to
exsanguination?

No. [Justify the omission of pain-relieving agents]{.underline} here;
then proceed to item 5:

Yes. [Describe the administration of pain-relieving agents]{.underline}
including dose (mg/kg), volume (ml), route, and frequency/duration here;
then proceed to item 5:

c\. How will you make sure that the animals are dead following blood
withdrawal?

5\. How will the antigens or cell lines listed in items 1.b., 2.b., and
3.a. be screened to make sure they do not harbor infectious agents that
could infect other laboratory animals or people after injection?

6\. Return to the main ACORP form and continue with item P.

ACORP Appendix 3

Test Substances

Version 3

1\. **Toxic Agents.** Will toxic chemicals, toxic pharmacologic agents,
known or suspected mutagens, carcinogens, teratogens, DNA-binding, or
other similar agents be used in animals?

> No. Proceed to item 2.
>
> Yes. Complete items 1.a, 1.b, 1.c, and 1.d, then proceed to item 2.
>
> a\. Table of toxic agents:

+-----------+-----+--------+---------+-------------+------------------+
| # Agent   | D   | Route  | Dose    | Frequency   | Reason for       |
|           | ilu | of     | (e.g.   | and         | admin., and      |
|           | ent | admin. | mg/kg)  | duration of | expected effects |
|           |     |        | and     | adm         |                  |
|           |     |        | Volume  | inistration |                  |
|           |     |        | (ml)    |             |                  |
+-----------+-----+--------+---------+-------------+------------------+
|           |     |        |         |             |                  |
+-----------+-----+--------+---------+-------------+------------------+
|           |     |        |         |             |                  |
+-----------+-----+--------+---------+-------------+------------------+
|           |     |        |         |             |                  |
+-----------+-----+--------+---------+-------------+------------------+

> b\. Indicate which of the above agents, if any, are known or suspected
> mutagens, carcinogens, or teratogens:
>
> c\. Are any of the agents above on the CDC/USDA list of "select
> agents" that might have bioterrorism? Check the appropriate response
> below and proceed to item 1.d.
>
> No.
>
> Yes, but agent(s) will be used in quantities that fall below minimums
> specified by \"select agent\" legislation, and thus these agents are
> not covered by \"select agent: legislation.
>
> Yes. Ask your research office to contact the VACO Chief Biosafety
> Officer for further instructions as soon as possible. You will have to
> obtain a CDC and/or USDA license and VACO approval before beginning
> your studies with this agent.
>
> d\. Will the animals be anesthetized or sedated when these agents are
> administered?
>
> No. Proceed to item 2.
>
> Yes. [Detail the method]{.underline} of anesthetic, sedative, or
> tranquilizer administration including agent, dose and volume, and
> route; then proceed to item 2:

2\. **Infectious Agents.** Will bacteria (including rickettsia),
viruses, fungi, protozoa, prions, or other infectious agents be used in
animals? If the agent will have a radioactive label added, also complete
item 4 below. Likewise, if the infectious agent contains recombinant
nucleic acid, fill out item 6 below for the agent as well.

> No. Proceed to item 3.
>
> Yes. Complete items 2.a, 2.b, 2.c, and 2.d; then proceed to item 3.
>
> a\. Complete the table below:

  ------------------- ------------ -------- ----------------- ----------------
  Agent and strain or CDC          Route of Dose (e.g. CFU,   Frequency of
  construct           Biosafety    admin.   PFU) and volume   administration
                      Level of              administered (ml) 
                      agent (BSL1,                            
                      2, 3, 4)                                

                                                              

                                                              

                                                              
  ------------------- ------------ -------- ----------------- ----------------

b\. Has an antibiogram, anti-viral drug sensitivity screen, or other
appropriate drug sensitivity panel been determined for the agent(s)
listed to assist physicians in selecting proper therapy if an
inadvertent human infection occurs?

> c\. Will the animals be anesthetized or sedated when these agents are
> administered?
>
> No. Proceed to item 2.d.
>
> Yes. [Detail the method]{.underline} of anesthetic, sedative, or
> tranquilizer administration including agent, dose and volume, and
> route; then proceed to item 2.d:
>
> d\. Are any of the agents on the CDC/USDA list of "select agents" that
> might have bioterrorism uses? Check the appropriate response below and
> proceed to item 3.
>
> No.
>
> Yes. Ask your research office to contact the VACO Chief Biosafety
> Officer for further instructions as soon as possible. You will have to
> obtain a CDC and/or USDA license and VACO approval before beginning
> your studies with this agent.

3\. **Biological Materials.** Will serum, cell lines, tissue, nucleic
acid or other biological materials be administered to animals? If any of
the agents are radioactive or will have a radioactive label added, also
complete item 4 for that agent.

> No. Proceed to item 4.
>
> Yes. Complete items 3.a., 3.b., and 3.c.; then proceed to item 4.
>
> a\. Table of biological materials:

+--------------+-------+----------+------+---------+-------+---------+
| Material     | Di    | Source   | R    | Dose    | Freq. | Reason  |
| (e.g. fluid, | luent |          | oute | (e.g.   | and   | for     |
| cells,       |       | (e.g.    | of   | ml/kg,  | dur   | admin., |
| tissues)     |       | vendor,  | ad   | mg/kg,  | ation | and     |
|              |       | other    | min. | ce      | of    | e       |
|              |       | animals, |      | lls/kg) | a     | xpected |
|              |       | co       |      | and     | dmin. | effects |
|              |       | lleague) |      | volume  |       |         |
|              |       |          |      | (ml)    |       |         |
+--------------+-------+----------+------+---------+-------+---------+
|              |       |          |      |         |       |         |
+--------------+-------+----------+------+---------+-------+---------+
|              |       |          |      |         |       |         |
+--------------+-------+----------+------+---------+-------+---------+
|              |       |          |      |         |       |         |
+--------------+-------+----------+------+---------+-------+---------+

> b\. Will the animals be anesthetized or sedated when these agents are
> administered?
>
> No. Proceed to item 4.
>
> Yes. [Detail the method]{.underline} of anesthetic, sedative, or
> tranquilizer administration including agent, dose and volume, and
> route; then proceed to item 4:
>
> c\. How will these materials be screened to make sure they do not
> harbor infectious agents that could infect other laboratory animals or
> people?

4\. **Radioactive Agents.** Will radioactive compounds or agents be
administered to animals?

> No. Proceed to item 5.
>
> Yes. Complete items 4.a., 4.b., and 4.c.; then proceed to item 5.
>
> a\. Table of radioactive agents:

  ------------- --------- ---------- ---------- -------- ----------- -------------
  Radioactive   Diluent   Agent dose Activity   Route of Frequency   Reason for
  Agent                   (mg/kg)    (e.g.      admin.   and         admin., and
  (include                and Vol.   mCi/kg)             duration of expected
  isotope)                (ml)                           admin.      effects

                                                                     

                                                                     

                                                                     
  ------------- --------- ---------- ---------- -------- ----------- -------------

> b\. Which investigator has been given permission by the Radiation
> Safety Committee or equivalent committee to utilize the isotope(s)
> indicated above?
>
> c\. Will the animals be anesthetized or sedated when these agents are
> administered?
>
> No. Proceed to item 5.
>
> Yes. [Detail the method]{.underline} of anesthetic, sedative, or
> tranquilizer administration including agent, dose and volume, and
> route; then proceed to item 5:

5\. **Other Agents.** Will other substances not listed previously in
this appendix be administered to animals? Do not include
anesthetics/analgesics/sedatives you will describe elsewhere in the
ACORP as part of surgery and postoperative care.

> No. Proceed to item 6.
>
> Yes. Complete items 5.a. and 5.b.; then proceed to item 6.
>
> a\. Table of other agents:

  ------------- --------- ------------- -------- ----------- ----------------
  Agent         Diluent   Agent dose    Route of Frequency   Reason for
                          (e.g. mg/kg)  admin.   and         admin., and
                          and Vol. (ml)          duration of expected effects
                                                 admin.      

                                                             

                                                             

                                                             
  ------------- --------- ------------- -------- ----------- ----------------

> b\. Will the animals be anesthetized or sedated when these agents are
> administered?
>
> No. Proceed to item 6.
>
> Yes. [Detail the method]{.underline} of anesthetic, sedative, or
> tranquilizer administration including agent, dose and volume, and
> route; then proceed to item 6:

6\. **Recombinant nucleic acid and recombinant infectious agents.**

> a\. Do any of the agents noted above in items 1-5 above have
> recombinant nucleic acid in them?
>
> No. Proceed to item 7.
>
> Yes. Answer item 6.b. **If yes, please list agents** **here and/ list
> what proteins will be expressed in animals injected with these
> agents;**
>
> **Complete section E. Recombinant DNA** in the safety form.
>
> **Agents:**
>
> b\. Are the recombinant constructs [exempt]{.underline} from the
> animal research guidelines included in the latest version of the *NIH
> Guidelines for Research Involving Recombinant DNA Molecules*
> publication? Consult with your Biosafety Committee and veterinarian to
> make sure you comply and provide relevant documentation (IBC Approval
> Letter, etc...) attached to the safety form.
>
> No. You must conduct the animal experiments involving recombinant
> nucleic acid according to the *NIH Guidelines for Research Involving
> Recombinant DNA Molecules*. Go to item 7.
>
> Yes. Go to item 7

7\. **Pain or Distress**. Will animals potentially experience pain
and/or distress as a result of the administration of agents listed above
in items 1, 2, 3, 4, 5, or 6?

> No. Proceed to item 8.
>
> Yes. [Describe the nature of the pain and/or distress]{.underline}
> that animals might experience and describe measures that will be taken
> to alleviate any pain and/or distress here, then proceed to item 8:

8\. **Hazardous/Toxic Agents.** Are any of the agents listed above in
items 1-6 hazardous or toxic to humans or animals, or covered by the
*NIH Guidelines for Recombinant DNA and Gene Transfer*?

> No. **You have completed this appendix; *no further information is
> required in this appendix. Go to item Q on the ACORP****. **[YOU DO
> NOT NEED TO GET SIGNATURES IN ITEM 9. BELOW!]{.underline} ***
>
> Yes. Complete items 8.a., 8.b., and 9; then return to item Q on the
> ACORP.
>
> a\. Table of hazardous agents, committee approvals, and personnel
> exposed:

+-----------------+----------------+--------+------------------------+
| > Toxic or      | Safety,        | In     | List all animal        |
| > hazardous     | biosafety, or  | dicate | facility staff who     |
| > agent(s) from | radiation      | w      | will come in contact   |
| > items 1-5     | safety         | hether | with animals given     |
| > above, or     | committee that | VA or  | these agents or with   |
| > non-exempt    | has approved   | aff    | contaminated bedding,  |
| > agent(s) from | the use of     | iliate | cages, or other items. |
| > item 6.       | this hazardous | com    |                        |
|                 | agent          | mittee |                        |
+-----------------+----------------+--------+------------------------+
|                 |                |        |                        |
+-----------------+----------------+--------+------------------------+
|                 |                |        |                        |
+-----------------+----------------+--------+------------------------+
|                 |                |        |                        |
+-----------------+----------------+--------+------------------------+

> b\. Detail how the individuals listed in the table above (item 8.a.)
> [have been (or will be) informed of the possible risks of
> exposure]{.underline}, and [have been (or will be) trained to avoid
> exposure to these agents]{.underline}:

9\. **Signatures.** By our signatures, we certify that:

a\. Before any animal experiments involving the agents listed in item
8.a. are performed, SOPs designed to protect all animal facility staff
as well as non-study animals will be developed and approved by the
appropriate VA or affiliated university safety committee and the IACUC;
and

b\. All staff that might be exposed to these agents will be informed of
possible risks and will be properly trained to follow the SOPs to
minimize the risk of exposure. As is appropriate, concurrence signatures
from biosafety or radiation safety personnel are also required as shown.

  ------------------------------ ------------------------- --------------
  Principal Investigator(s)      Signature(s)              Date

                                                           

                                                           

                                                           

  Institutional Veterinarian     Signature                 Date

                                                           

  Biosafety Officer or Chair,    Signature                 Date
  Research Safety or Biosafety                             
  Committee (typed)                                        

                                                           

  Radiation Safety Officer, or   Signature                 Date
  Chair, Radiation Safety or                               
  Isotope Committee (typed)                                

                                                           

  IACUC Chair (typed)            Signature                 Date

                                                           
  ------------------------------ ------------------------- --------------

ACORP Appendix 4

**[Antemortem Specimen Collection]{.smallcaps}**

**[Version 3]{.smallcaps}**

1\. **Blood Collection.** Will blood be collected from live animals
(anesthetized or awake) as a part of this proposal?

> No. Proceed to item 3.
>
> Yes, but all collections are described in Appendix 2, "Antibody
> Production", so no further information need be provided here; proceed
> to item 3.
>
> Yes. Complete the table below; then proceed to item 2.

  ----------------------- --------------------- ------------- -------------
  Site and Method of      Amount of blood       Number of     Interval
  blood collection        collected, expressed  blood         between
                          as volume (ml) and %  collections   collections
                          of body weight                      
                          (assume 1 ml of blood               
                          weighs 1 gram)                      

                                                              

                                                              

                                                              
  ----------------------- --------------------- ------------- -------------

2\. **Use of Anesthetics, Tranquilizers, or Analgesics for Blood
Collection**. Will anesthetics, tranquilizers, or analgesics be used to
prevent pain or stress during collection of blood described in item 1
above?

> No. [Justify the omission of pain-relieving agents]{.underline}
> (either scientifically or because the collection method involves no or
> momentary pain) and [completely describe the physical
> restraint]{.underline} that will be used during collection here:
>
> Yes. Complete the following table, then proceed to item 3.

+-------------------------+----------------+-----------+--------------+
| Anesthetic,             | Dose (mg/kg) & | # Route   | ## Frequency |
| tranquilizer, or        | volume (ml)    |           |              |
| analgesic agent         |                |           |              |
+-------------------------+----------------+-----------+--------------+
|                         |                |           |              |
+-------------------------+----------------+-----------+--------------+
|                         |                |           |              |
+-------------------------+----------------+-----------+--------------+
|                         |                |           |              |
+-------------------------+----------------+-----------+--------------+

3\. **Other Tissue Collection.** Will other body fluids (e.g.
cerebrospinal fluid, peritoneal fluid, urine) or tissues be collected
from live animals (awake or anesthetized) as a part of this protocol?

> No. Proceed to item 5.
>
> Yes. Complete the following table; then proceed to item 4.

  ----------------- -------------- -------------- ------------- -------------
  Tissue or fluid   Site & method  Amount (g) or  Number of     Interval
  collected         of collection  volume (ml)    collections   between
                                                                collections

                                                                

                                                                

                                                                
  ----------------- -------------- -------------- ------------- -------------

4\. **Use of** **Anesthetics, Tranquilizers, or Analgesics for
Collection of Fluids or Tissues**. Will anesthetics, tranquilizers, or
analgesics be used to prevent pain or stress during collection of body
fluids or tissues described in item 3 above?

> No. [Justify the omission of pain-relieving agents]{.underline}
> (either scientifically or because the collection method involves no or
> momentary pain) and [completely describe the physical
> restraint]{.underline} that will be used during collection here, then
> go to item 5:
>
> Yes. Complete the following table, then go to item 5.

+-------------------------+----------------+-----------+--------------+
| Anesthetic,             | Dose (mg/kg) & | # Route   | ## Frequency |
| tranquilizer, or        | volume (ml)    |           |              |
| analgesic agent         |                |           |              |
+-------------------------+----------------+-----------+--------------+
|                         |                |           |              |
+-------------------------+----------------+-----------+--------------+
|                         |                |           |              |
+-------------------------+----------------+-----------+--------------+
|                         |                |           |              |
+-------------------------+----------------+-----------+--------------+

5\. Proceed to item S on the ACORP.

ACORP Appendix 5

**[Surgery]{.smallcaps}**

**[Version 3]{.smallcaps}**

1\. **Major survival surgery.** The *Guide* defines a major survival
surgery as a surgery in which a major body cavity is penetrated and
exposed or surgery in which substantial impairment of physical or
physiological functions is produced. Examples of such surgeries provided
in the *Guide* include laparotomy, thoracotomy, craniotomy, joint
replacement, and limb amputation.

> a\. Will more than one major survival surgery be performed on any
> animal as part of the proposed experimental plan?
>
> No. Proceed to item 2.
>
> Yes. Complete item 1.b. and 1.c. below.
>
> b\. Provide a [complete scientific justification]{.underline} for
> performing more than one major survival surgery on individual animals:
>
> c\. [Give the interval(s)]{.underline} between the multiple surgeries,
> [and the rationale]{.underline} for choosing the interval(s) here,
> then proceed to item 2:

2\. **Description of Procedure(s).** Describe the surgical procedure(s)
in enough detail so that the IACUC reviewers can determine what
procedure(s) are actually being performed. If several different
surgeries are being performed, be sure to describe each one. When
finished, proceed to item 3:

3\. Provide the names of the personnel who will perform the surgery;
then proceed to item 4. Note that the surgical experience of each person
involved in surgery should be listed in item E of the ACORP:

4\. Provide the names of the personnel who will perform the anesthetic
induction and monitor the animal during surgery here, then proceed to
item 5:

5\. Provide the building and room number(s) where the surgical
procedure(s) will be performed. A dedicated surgical facility must be
used for major survival surgeries on non-rodent species (the definition
of a major survival surgery is provided in item 1 above). If allowed by
local policy, non-survival surgery on non-rodent species and survival
surgery on rodent species may be performed in a procedure room or
laboratory. Then proceed to item 6:

6\. **Pre-operative procedures.** Pre-operative procedures should
include all preparations of the animal(s) for surgery. Check and
describe which of the following procedures will be performed. Then
proceed to item 7.

> Fasting (rarely used in rodents or rabbits). [Indicate the length of
> the fasting period]{.underline}:
>
> Withhold water. [Indicate the length of time that water will be
> withheld]{.underline}:
>
> Catheter placement. [Indicate the site(s)]{.underline} in which venous
> catheter(s) will be placed for vascular access during surgery:
>
> Other. [Describe]{.underline} other pre-operative procedures:

7\. **Pre-operative medications.** Complete the following table. Include
any antibiotics, sedatives, or tranquilizers, and the anesthetic
agent(s) that will be used to induce anesthesia prior to surgical site
preparation; then proceed to item 8.

+----------------+--------------+------------+--------------+----------+
| Agent          | Dose (mg/kg) | ## Route   | Frequency    | Duration |
|                | & volume     |            |              |          |
|                | (ml)         |            | (e.g.        | (e.g.    |
|                |              |            | times/day)   | days)    |
+----------------+--------------+------------+--------------+----------+
|                |              |            |              |          |
+----------------+--------------+------------+--------------+----------+
|                |              |            |              |          |
+----------------+--------------+------------+--------------+----------+
|                |              |            |              |          |
+----------------+--------------+------------+--------------+----------+

8\. **Preparation of the surgical site.** [Detail]{.underline} how the
surgical site(s) will be prepared prior to surgery. Include details of
hair-clipping, skin disinfection, and the use of surgical drapes. Then
proceed to item 9:

9\. **Intraoperative medications.** Complete the following table
including any anesthetic agents, paralyzing agents, fluids, or other
pharmaceuticals that will be administered to the animal during surgery.
Also include experimental pharmaceuticals. Then proceed to item 10.

  -------------------- --------------- ---------- -----------------------
  Agent                Dose (mg/kg) &  Route      Frequency
                       volume (ml)                

                                                  

                                                  

                                                  
  -------------------- --------------- ---------- -----------------------

10\. **Paralyzing agents.** Are any of the above medications considered
paralyzing agents?

> No. Proceed to item 11.
>
> Yes. **Very Important!!** Federal regulations prohibit the use of
> paralytics (neuromuscular blocking agents) for surgery [unless other
> appropriate anesthetic agents are used to induce a surgical plane of
> anesthesia]{.underline}. Paralytics do not provide any pain relief;
> therefore, animals are unable to respond physically to pain because
> motor reflexes are paralyzed. [Justify]{.underline} the use of these
> agents and indicate how the animals will be monitored to ensure that
> the depth of anesthesia is sufficient to prevent pain. Then proceed to
> item 11:

11\. **Physical support.** Decribe any physical methods used to support
patients during surgery (e.g. heating pads, blankets, etc.); then
proceed to item 12:

12\. **Intra-operative monitoring.** Describe methods used to monitor
the state of anesthesia and general well-being of the animal during
surgery. Then proceed to item 13:

13\. Will the animals regain consciousness following surgery?

> No. You have completed this appendix. ***No further information is
> required in this appendix. Return to item T on the ACORP itself.***
>
> Yes. Proceed to item 14.

14\. **Survival surgery considerations and post-operative care.**
Complete items 14.a-f. below. Then proceed to item 15.

> a\. How long will the animal(s) survive after surgery? (If multiple
> surgeries are planned, answer for the last surgery before euthanasia):

b\. Is the room where the procedures will be performed (listed in item 5
above) suitable for sterile/aseptic surgery?

> c\. Indicate which of the following procedures will be used to
> maintain a sterile field during surgery:
>
> Sterile instruments.
>
> Surgeon cap.
>
> Sterile gloves.
>
> Surgeon scrub.
>
> Sterile drapes.
>
> Sterile gown.
>
> Face mask.
>
> Other. [Describe]{.underline}:
>
> d\. List any methods used to support the patients in the immediate
> post-operative period (e.g., heating pads, blankets, fluids, etc.):
>
> e\. Unless scientifically or otherwise justified to the IACUC's
> satisfaction, you are obligated to routinely provide post-operative
> pain relief for all vertebrate animals undergoing survival surgery. Do
> you plan to use analgesics to provide postoperative pain relief to the
> animals following surgery?
>
> No. [Provide a justification for not using postoperative
> analgesics]{.underline} here:
>
> Yes. Complete the following table listing post-operative analgesics
> agent(s) that will be used after surgery to control pain:

+--------------------+------------+-----------+-----------+----------+
| Agent              | Dose       | Route     | Frequency | Duration |
|                    | (mg/kg) &  |           |           |          |
|                    | Volume     |           | (e.g.     | (e.g.    |
|                    | (ml)       |           | t         | days)    |
|                    |            |           | imes/day) |          |
+--------------------+------------+-----------+-----------+----------+
|                    |            |           |           |          |
+--------------------+------------+-----------+-----------+----------+
|                    |            |           |           |          |
+--------------------+------------+-----------+-----------+----------+
|                    |            |           |           |          |
+--------------------+------------+-----------+-----------+----------+

f\. Complete the following table for other medications (such as fluids,
antibiotics, anti-coagulants, and other pharmacological agents) that
will be administered post-operatively.

+------------------+-------------+------------+-----------+----------+
| Agent            | Dose        | Route      | Frequency | Duration |
|                  | (mg/kg) &   |            |           |          |
|                  | Volume (ml) |            | (e.g.     | (e.g.    |
|                  |             |            | t         | days)    |
|                  |             |            | imes/day) |          |
+------------------+-------------+------------+-----------+----------+
|                  |             |            |           |          |
+------------------+-------------+------------+-----------+----------+
|                  |             |            |           |          |
+------------------+-------------+------------+-----------+----------+
|                  |             |            |           |          |
+------------------+-------------+------------+-----------+----------+

15\. **Frequency and Responsibility for post-operative care.** Complete
items 15.a. and 15.b. below. Then proceed to item 16.

a.  Give the frequency of postoperative monitoring and how long the
    monitoring will continue:

b.  Who will be responsible for post-operative care until the animal can
    ambulate without danger to itself?

c.  Who will be responsible for post-operative care thereafter
    (including after-hours, weekends, and holidays)?

d.  Provide after-hours telephone (or other contact) numbers of
    personnel listed above in case of an emergency.

16\. **Post-operative complications.** Complete items 16.a. - d. below;
then proceed to item 17.

a.  Describe any possible or expected post-operative complications and
    what will be done if these complications arise:

b.  Provide criteria by which a decision to euthanatize a surgical
    patient post-operatively will be made:

c.  In case there is an emergency medical situation and you or your
    staff cannot be reached, identify drugs or classes of drugs that
    should not be used as part of the treatment plan:

d.  In the event that emergency euthanasia must be performed or an
    animal is unexpectedly found dead, how should the carcass be
    handled?

17\. **Responsibility for maintaining animal post-surgical medical
records.** Who will be responsible for maintaining accurate, daily,
post-surgical written medical records?

> My research staff or I will be responsible. Proceed to item 18 below.
>
> The veterinary staff will be responsible. Proceed to item 18 below.
>
> Local policy does not mandate that postoperative medical records be
> maintained for the species covered by this ACORP. ***You have
> completed this Appendix. [Do not answer item 18 or sign under item
> 18.]{.underline} Instead, go to item T on the ACORP*.**
>
> Other. [Please explain]{.underline}, then proceed to item 18 below:

18\. **Certifications.** Complete the following; then return to item T
on the ACORP and continue.

> By my signature, I certify that

-   Each patient under observation or treatment will be identified such
    that care for individual animals can be documented.

-   Daily postoperative medical records of the patient will be
    maintained, including an evaluation of overall health, a description
    of any complications noted, treatment provided, and the removal of
    sutures, staples, wound clips, or other such devices.

-   Records will document administration of all medications and
    treatments given to animals, including those given to reduce pain or
    stress.

-   As a minimum, daily records will cover the postoperative period as
    defined by local policy.

-   Each entry in the records will include a signature or the initials
    of the person making the observation or treatment.

-   All records will be readily available to the veterinary staff or the
    IACUC for review.

-   The names and contact numbers of persons to notify or consult in
    case of emergencies will be provided to the facility manager and
    veterinarian.

  ------------------------------- -------------------------- ------------
  Name of Principal               Signature(s)               Date
  Investigator(s)                                            

                                                             

                                                             

                                                             
  ------------------------------- -------------------------- ------------

ACORP Appendix 6

**[Special Husbandry and Procedures]{.smallcaps}**

**[Version 3]{.smallcaps}**

1\. **Special Husbandry.** Are special husbandry practices required for
this protocol that are not described in the local Standard Operating
Procedures (SOP) manual? Examples of special husbandry practices include
temperature extremes, food or water deprivation, dietary manipulations,
calorie restrictions, special housing/caging, modified light cycle,
special health monitoring, and unusual means of identification.

> No. Proceed to item 2.
>
> Yes. Complete items 1.a. and 1.b.; then proceed to item 2.

a.  [Provide a complete description]{.underline} of all non-standard
    practices or procedures. Make sure that the frequency and duration
    of these practices or procedures are stated:

b.  [Justify the use of these non-standard practices or
    procedures]{.underline}:

2\. **Other Procedures.** Are other procedures such as prolonged
physical restraint, use of noxious stimuli, forced exercise, behavioral
manipulations, total or partial body irradiation, radiography or other
imaging studies planned but not described elsewhere in the ACORP?

> No. Proceed to item 3.
>
> Yes. Complete items 2.a. and 2.b.; then proceed to item 3.

a\. Check [all]{.underline} of the following procedures that are
proposed:

> Prolonged physical restraint, including chairing.
>
> Noxious stimuli.
>
> Forced exercise.
>
> Behavioral manipulations.
>
> Other. [Describe]{.underline}:

b.  [Describe each procedure and the expected outcome(s) in
    detail]{.underline}. Make sure that the frequency, duration, and
    interval between repeated manipulations are described:

3\. In the table below, identify who will perform the procedures and
practices listed in items 1 and 2 and who will be responsible for
monitoring the condition of these animals. [After-hours telephone (or
other contact) numbers of the personnel listed must be provided to the
veterinary staff in case of an emergency]{.underline}.

+------------------+---------+---------+---------+---------+---------+
| Person           | Role    | #       | Pager   | Afte    | E-mail  |
|                  | (per    | # Offic | or cell | r-hours | address |
|                  | forming | e Phone | phone   | contact |         |
|                  | pro     |         |         | number  |         |
|                  | cedure/ |         |         |         |         |
|                  | moni    |         |         |         |         |
|                  | toring) |         |         |         |         |
+------------------+---------+---------+---------+---------+---------+
|                  |         |         |         |         |         |
+------------------+---------+---------+---------+---------+---------+
|                  |         |         |         |         |         |
+------------------+---------+---------+---------+---------+---------+
|                  |         |         |         |         |         |
+------------------+---------+---------+---------+---------+---------+

4\. Do these practices or procedures have the potential to cause more
than momentary pain and/or discomfort?

> No. You have completed this appendix**;\
> *no further information is required in this appendix. Go to item W on
> the ACORP.***
>
> Yes. [Describe the potential pain and/or discomfort]{.underline} here;
> then proceed to item 5:

5\. Will pain or stress-relieving agents be administered to the animals
that experience pain and/or discomfort? Then proceed to item 6.

> No. [Provide a scientific justification for not using pain or stress
> relieving agents]{.underline} here:
>
> Yes. Fill out the table below.

+-----------------+-------------+-----------+------------+------------+
| Agent           | Dose        | ## Route  | Frequency  | Duration   |
|                 | (mg/kg) &   |           |            |            |
|                 | volume (ml) |           | (e.g.      | (e.g.      |
|                 |             |           | times/day) | days)      |
+-----------------+-------------+-----------+------------+------------+
|                 |             |           |            |            |
+-----------------+-------------+-----------+------------+------------+
|                 |             |           |            |            |
+-----------------+-------------+-----------+------------+------------+
|                 |             |           |            |            |
+-----------------+-------------+-----------+------------+------------+

6\. Describe the methods used to monitor the condition of the animals
during and after the procedures and the criteria that will be used to
remove individual animals from these procedures should pain or suffering
be present:

7\. Proceed to item W on the ACORP.

**ACORP Appendix 7**

**[Request to Use Patient Care Procedural Areas for Animal
Studies]{.smallcaps}**

**Version 3**

1\. Name of Principal Investigator(s):

2\. Provide a concise statement of the potential benefit to VA patients
if a patient care area is used for research involving animals.

3\. Why can't the animal facility or a laboratory area be utilized for
the proposed procedures?

4\. Identify the species and number of animals to be used.

5\. Discuss the potential pain and/or distress to animal subjects during
the procedures to be conducted in a patient procedural area, and
interventions planned for the prevention or alleviation of such
pain/distress.

6\. Identify the equipment and location (building and room numbers) of
the patient care area(s) to be used.

7\. List the date(s) and time of day that the procedure(s) will be
performed.

8\. Discuss the method of transporting the animals to and from the
procedural area. Include a description of the transport containers, any
vehicles used, and precautions to be taken to avoid contact with
patients, visitors, and other non-research personnel.

9\. Provide a complete description of the measures to be taken to
prevent the transmission of zoonotic pathogens from animals to patients
and patient care personnel.

10\. Provide a complete description of the measures to be taken to
prevent disturbances (e.g., noise, odors) to patients and patient care
personnel.

11\. Provide a complete description of methods to be employed to prevent
contamination of equipment and room surfaces by animal feces, urine,
saliva, blood, or other body fluids.

12\. Provide details of the procedures to be followed in cleaning and
disinfecting equipment and room surfaces following use.

13\. Required signatures. (If this appendix is part of an ACORP, return
to item X.3. on the ACORP.)

> a\. Principal Investigator(s) submitting this request.

  -----------------------------------------------------------------------
  Name(s) of Principal        Signature(s)                  Date
  Investigator(s) (typed)                                   
  --------------------------- ----------------------------- -------------
                                                            

                                                            

                                                            
  -----------------------------------------------------------------------

> b\. Approving officials.

  --------------------------- ----------------------------- -------------
  Name of IACUC Chair (typed) Signature                     Date

                                                            

  Name of Attending           Signature                     Date
  Veterinarian (VMO or VMC,                                 
  typed)                                                    

                                                            

  Chair, Clinical Executive   Signature                     Date
  Board or Service Chief                                    
  responsible for the patient                               
  care equipment (typed)                                    

                                                            

  ACOS for R&D (typed)        Signature                     Date

                                                            

  Chief of Staff (typed)      Signature                     Date

                                                            

  Facility (Hospital or       Signature                     Date
  Clinic) Director or CEO                                   
  (typed)                                                   

                                                            
  --------------------------- ----------------------------- -------------

**ACORP Appendix 8**

**[Request to Use Explosive Agent in the Animal Facility or in
Animals]{.smallcaps}**

**[Version 3]{.smallcaps}**

1\. Principal Investigator(s):

2\. Give the name(s), title(s), and prior pertinent training and
experience of individuals who will administer the explosive agent.

3\. Name of the explosive agent(s), and the Material Safety Data Sheet
number(s):

4\. Why can't a non-explosive agent or agents be used instead?

5\. Give the beginning and ending dates during which the explosive
agent(s) will be used.

6\. Give a brief description of the studies for which the use of an
explosive agent is proposed.

7\. Give the species, weight, and approximate number of animal subjects
that will be administered the explosive agent(s).

8\. Give the building and room number in which agent(s) will be used.

9\. Give a detailed description of the procedure(s) involving the
explosive agent(s) including assurances that: a) procedures are
performed within a properly operating, ventilated safety hood, b) all
electrical equipment used with the agent are placed and powered outside
the hood, c) once the seal is broken on containers of ether or other
explosive anesthetic agents, they will be placed into a safety hood
throughout use, stored in an explosion proof refrigerator or other
approved storage area, and discarded properly once completely used, and
d) that proper disposal procedures for items (including carcasses)
containing traces of the agent will be safe and appropriate. (When
finished, proceed to item Y on the ACORP.)

**10. Required signatures.**

> a\. Principal Investigator(s) submitting this request.

  --------------------------- ------------------------------ -------------
  Name(s) of Principal        Signature(s)                   Date
  Investigator(s) (typed)                                    

                                                             

                                                             

                                                             
  --------------------------- ------------------------------ -------------

> b\. Approving officials.

  --------------------------- ------------------------------ -------------
  Name of IACUC Chair (typed) Signature                      Date

                                                             

  Name of Attending           Signature                      Date
  Veterinarian (VMO or VMC,                                  
  typed)                                                     

                                                             

  Facility Safety/Biosafety   Signature                      Date
  Officer (typed)                                            

                                                             

  ACOS for R&D (typed)        Signature                      Date

                                                             

  VISN Regional Safety        Signature                      Date
  Officer (typed)                                            

                                                             
  --------------------------- ------------------------------ -------------

**ACORP Appendix 9**

**[Additional Local Information]{.smallcaps}**

**Biohazard Containment Caging**

Biohazard or other special hazard containment caging will be required as
indicated by the ACORP application. A separate Appendix 9
**[MUST]{.underline}** be completed **for each agent** the animal is
exposed to UNLESS these agents all have the same requirement for housing
and quarantine.

**[YOU MUST MAKE ARRANGEMENTS WITH THE VMU SUPERVISOR PRIOR TO EXPOSING
ANIMALS TO THIS AGENT IF SPECIAL HOUSING IS REQUIRED!]{.underline}**

1\. Animals requiring special hazard containment caging will be exposed
to the following agent(s):

2\. Special housing requirements for animals post-exposure to agent(s)
indicated above --

> Please check all that apply:

House in negative pressure facility

Autoclave all supplies out

Autoclave all supplies in

Autoclave all supplies in and out

3\. How is the agent excreted from the exposed animal?

4\. Will the exposed animal be hazardous to other animals of the same
species and for how long?

5\. Will the exposed animal be hazardous to animals of a different
species and for how long?

6\. If the exposed animal is hazardous, how many days before it can be
returned to normal caging?

7\. Any other special consideration or information for the Veterinary
Medical Unit?

**VA LABORATORY SAFETY HAZARD ASSESSMENT FORM**

**Research Safety Subcommittee**

**VA Ann Arbor Healthcare System (506)**

##### 2215 Fuller Rd., Ann Arbor, MI 48105

  ------------------------ ------------ ------------ --------------- -------------
  **Principal                           **Email                      
  Investigator:**                       Address:**                   

  **Lab Personnel List:**               **Email                      
                                        Address:**                   

  **Project Title:**                                 **Submission    
                                                     Date:**         

  **Building:**            **Room #:**               **Mail Code:**  **Lab
                                                                     Phone:**
  ------------------------ ------------ ------------ --------------- -------------

Will the project use any of the following? (Please check all that
apply.)

**\[ \] A**. **Human tissue, including blood, other body fluids and cell
lines**

**\[ \] B**. **Ionizing Radiation (radioactive materials or radiation
producing equipment)\
**[If this item is checked, applicant must have one of the following
approvals:]{.underline}

\(1\) For work performed at the VA, the applicant must have an approved
Ann Arbor VA Application to Use Radioisotopes in Research form which is
available in the Radiation Safety Office, or

\(2\) For work using radiation producing devices performed at the VA,
the applicant must be approved by the Radiation Safety Committee, or

\(3\) For work performed in University space, appropriate, current
University approval(s) must be attached to this form.

**\[ \] C**. **Biological Agents** (including microbiological, viral or
plant agents, pathogens, toxins, poisons or venoms)

**\[ \] D**. **Chemicals (If you are using [any]{.underline} chemicals
in these studies, this must be checked)**

**\[ \] E**. **Recombinant DNA** (appropriate UM approval(s) must be
attached to this form.)

**\[ \] F Non-Human Cell lines and Tissue Culture** (This must be
checked if the research involves work with blood, body fluids, organs,
tissues, cell lines or cell clones from non-human primates or animal
sources)

**\[ \] G. Physical agents (UV light, lasers, radio-frequency or
microwaves, electricity, trauma)**

**\[ \] H. Animals - If this item is checked, you must submit an
approved or new Animal Component of Research Protocol (ACORP) form.**

**\[ \] I. Controlled Substances (**If your research involve the use of
any substance regulated by the Drug Enforcement Agency)

**\[X\] J**. **Staff Training** [(This section must be
completed)]{.underline}

A.  **[Human tissue, including blood, other body fluids and cell
    lines]{.underline}\
    **(Applicants [must]{.underline} submit a VA Human Studies
    Application for any use of research subject samples.)

> 1\. Will human tissue, blood or body fluids be collected? **\[ \]**
> Yes **\[ \]** No\
> [If Yes, then answer these questions:]{.underline}
>
> a\) Describe the samples to be collected
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> b\) Where will the samples be collected: Building \# Room \#
> \_\_\_\_\_
>
> c\) Who will be collecting? **\[ \]** Clinical Staff **\[ \]** VA
> Research Staff
>
> **\[ \]** Other
> (specify):\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> d\) Where will the samples be analyzed? Building \# Room \# \_\_\_\_\_
>
> e\) Who will be analyzing? **\[ \]** VA Clinical Staff **\[ \]** VA
> Research Staff
>
> **\[ \]** Other
> (specify):\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> f\) How are the samples inactivated and disposed?
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> 2\. Will personnel work with human cell lines? **\[ \]** Yes **\[ \]**
> No
>
> If Yes, please complete table below:

  ----------------------- ------------------ ----------------------------
  **Cell line**           **Biosafety        **How Inactivated/Disposed**
                          Level**            

                                             

                                             

                                             

                                             

                                             
  ----------------------- ------------------ ----------------------------

> [If any cell lines are **BSL2**, you must answer questions 3-11 under
> Section C, Biological Agents.]{.underline}
>
> 3\. Are all laboratory personnel familiar with OSHA\'s \"Bloodborne
> Pathogen Regulations\" and have all personnel completed Bloodborne
> Pathogen Training? **\[ \]** Yes **\[ \]** No
>
> *(All VA employees [must]{.underline} attend the VA-based Bloodborne
> Pathogen Training when working with human specimens)*

**\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--**

**B. [Ionizing Radiation]{.underline}**

**1) Radioactive Materials:**

Where will this work be performed? Building \# \_\_\_\_\_ Room \#
\_\_\_\_\_

> a\) List all Isotopes to be used:

  --------------------------------- -------------------------------------
  Isotope Name                      Maximum Amount in Laboratory at any
                                    Time

                                    

                                    

                                    

                                    
  --------------------------------- -------------------------------------

> b\) If iodine is used, will compounds be radio-iodinating?
>
> **\[ \]** Yes **\[ \]** No If yes, what location? : Building \#
> \_\_\_\_\_ Room \# \_\_\_\_\_
>
> c\) Will radioisotopes be used in humans? **\[ \]** Yes **\[ \]** No
>
> [RADIATION SAFETY LICENSE VERIFICATION]{.underline} (check all that
> apply)
>
> **\[ \]** VA NRC License \# 03-23853-01 VA (VHA Permit \#
> 21-00159-04)\
> *For work performed at the VA, the applicant must have an approved Ann
> Arbor VA Application\
> to Use Radioisotopes in Research (the form is available in the VA
> Radiation Safety Office)*
>
> **\[ \]** UM License \# 21-00215-04\
> *For work performed in University space, you must attach the
> appropriate, current University approval(s)*
>
> **\[ \]** Not currently licensed. Name of licensed user who will
> supervise your work involving the use of radioisotopes:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **\[ \]** Not currently licensed. Do you have an application in
> progress? **\[ \]** Yes **\[ \]** No
>
> **2) Radiation Producing Devices: \[ \]** Yes **\[ \]** No
>
> If Yes, then:
>
> a\) What equipment will be used?
>
> b\) Where is the location of the equipment?
>
> c\) Who will be using the equipment ?
>
> d\) Will this equipment be used on: **\[ \]** Humans, **\[ \]**
> Animals,
>
> **\[ \]** other (please describe)
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> *For work using radiation producing devices performed at the VA, the
> applicant must be approved by the VA Radiation Safety Committee*

**\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--**

> **C. [Biological Agents]{.underline}** (including Microbiological,
> Viral or Plant agents, Pathogens, Toxins, Poisons or Venoms)
>
> 1\. Where will this work be performed? Building \# \_\_\_\_\_ Room \#
> \_\_\_\_\_
>
> [It is the responsibility of each PI to:]{.underline}
>
> a\) Consult the NIH-CDC publication entitled \"Biosafety in
> Microbiological and Biomedical Laboratories\"
> <http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm> **and**
>
> b\) Identify the Biosafety Level for each organism, agent or toxin
> below

+---------------------+-------+------------------+-----------+-------+
| **Org               | *     | **How            | **I       | **\*  |
| anism/Agent/Toxin** | *Bios | Inactivated/**   | nfectious | S     |
|                     | afety |                  | To        | elect |
|                     | Le    | **Disposed?**    | Humans?** | Age   |
|                     | vel** |                  |           | nt?** |
|                     |       |                  | **(       |       |
|                     |       |                  | Yes/No)** | **    |
|                     |       |                  |           | (Yes/ |
|                     |       |                  |           | No)** |
+---------------------+-------+------------------+-----------+-------+
|                     |       |                  |           |       |
+---------------------+-------+------------------+-----------+-------+
|                     |       |                  |           |       |
+---------------------+-------+------------------+-----------+-------+
|                     |       |                  |           |       |
+---------------------+-------+------------------+-----------+-------+
|                     |       |                  |           |       |
+---------------------+-------+------------------+-----------+-------+
|                     |       |                  |           |       |
+---------------------+-------+------------------+-----------+-------+
|                     |       |                  |           |       |
+---------------------+-------+------------------+-----------+-------+

> \* The CDC select agent list \[DHHS 42 CFR 72, Appendix A\] is
> included at [the](http://www.cdc.gov/od/ohs/lrsat/42cfr72.htm) end of
> this application)
>
> 2\. If you are requesting to use a Select Agent, give the required
> registration number for the transfer of the agent.
> #\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **For [each]{.underline} Organism/Agent/Toxin greater than Biosafety
> Level 1, you must answer questions 3-11.\
> For more than one agent, you must submit a separate set of answers.**
>
> **C. [Biological Agents:]{.underline} [Select Agents or Biosafety
> Level 2 Agents ]{.underline}**
>
> **(Use a separate page for each Agent)**
>
> \-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--
>
> [Additional Questions for Select Agents or Biosafety Level 2
> Agents]{.underline}
>
> 3\. Name of organism/agent/toxin \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> 4\. Is antibiotic resistance expressed? **\[ \]** Yes **\[ \]** No
>
> 5\. Largest volume of organism used is: \_\_\_\_\_ Liter(s)
> Concentration: \_\_\_\_\_
>
> 6\. Is organism inactivated prior to other lab manipulations? **\[
> \]** Yes **\[ \]** No
>
> 7\. Does this agent harbor any recombinant genes? **\[ \]** Yes **\[
> \]** No
>
> If Yes, please describe
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> If Yes, have you submitted this protocol to the UM IBC **\[ \]** Yes
> **\[ \]** No
>
> Applications can be submitted on-line at:
>
> <http://www.research.umich.edu/policies/um/committees/BRRC/BRRC.html>
>
> 8\. Specify methods of agent concentration (if applicable)
>
> **\[ \]** Centrifugation: **\[ \]** Precipitation:
>
> **\[ \]** Filtration: **\[ \]** Other:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> 9\. Specify methods of agent inactivation:
>
> **\[ \]** Heat **\[ \]** Chemical **\[ \]** Radiation
>
> **\[ \]** Other: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> 10\. How is inactivated material disposed?
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> 11\. What [containment equipment]{.underline} is available? (Check all
> that apply.)
>
> **\[ \]** Biological Safety Cabinet: **\[ \]** Class I **\[ \]** Class
> II **\[ \]** Class III\
> Date of Last Certification: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **\[ \]** Chemical Fume Hood
>
> **\[ \]** Containment Centrifuge **\[ \]** Centrifuge
>
> **\[ \]** Other: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> 12\. What methods will be employed to monitor the health and safety of
> personnel involved in this research?
>
> 13 If there is evidence of exposure, what course of action will be
> taken?

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

**\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--**

**D. [Chemicals]{.underline}** (Please answer all questions below with
information **pertaining to this study only**.\
[and]{.underline} ATTACH THE CHEMICAL INVENTORY FOR YOUR LABORATORY)

> **1**. [Toxic chemicals (including heavy metals)]{.underline} No **\[
> \]** Yes **\[ \]**
>
> Name of item(s): \_\_\_\_\_ Bldg \# \_\_\_\_\_ Rm \# \_\_\_\_\_
>
> **2**. [Flammable/explosive/corrosive chemicals]{.underline} No **\[
> \]** Yes **\[ \]**
>
> Name of item(s): \_\_\_\_\_ Bldg \# \_\_\_\_\_ Rm \# \_\_\_\_\_
>
> **3**. [Carcinogenic/mutgenic/teratogenic chemicals]{.underline} No
> **\[ \]** Yes **\[ \]**
>
> Name of item(s): \_\_\_\_\_ Bldg \# \_\_\_\_\_ Rm \# \_\_\_\_\_
>
> **4**. [Toxic compressed gases]{.underline} No **\[ \]** Yes **\[ \]**
>
> Name of item(s): \_\_\_\_\_ Bldg \# \_\_\_\_\_ Rm \# \_\_\_\_\_
>
> **5**. [Acetylcholinesterase inhibitors/neurotoxins]{.underline} No
> **\[ \]** Yes **\[ \]**
>
> Name of item(s): \_\_\_\_\_ Bldg \# \_\_\_\_\_ Rm \# \_\_\_\_\_
>
> **[Chemical Inventory:]{.underline}**
>
> If you are using chemicals, you must attach a complete Chemical
> Inventory list for your laboratory. [Please include these
> headings]{.underline}:
>
> Chemical Name, Bldg, Floor, Room, Room Function, End Point (use,
> disposal), Qty on Hand, Units, Yearly Use Est., Units, MSDS (Yes/No),
> Manufacturer.

**\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--**

**E. [Recombinant DNA ]{.underline}**

> You must submit an approval letter from the University of Michigan
> Institutional Biosafety Committee (IBC). Applications can be submitted
> on-line at:
>
> <http://www.research.umich.edu/policies/um/committees/BRRC/BRRC.html>
>
> 1\. Where will this work be performed? Building \# \_\_\_\_\_ Room \#
> \_\_\_\_\_

2\. DNA source(s): \_\_\_\_\_

3\. Nature of insert/protein expressed: \_\_\_\_\_

> 4\. Vector(s): \_\_\_\_\_
>
> 5\. Host: \_\_\_\_\_
>
> 6\. Cell/animal/plant recipient(s): \_\_\_\_\_
>
> 7\. Assessment of levels of physical and biological containment
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> (check relevant sections of NIH Guidelines, April 1998\
> <http://www.niehs.nih.gov/odhsb/biosafe/nih/rdna-apr98.pdf>

**\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--**

**F. [Non-Human Cell Lines and Tissue Culture]{.underline}** (including
work with blood, body fluids, organs, tissues,\
cell lines or cell clones from non-human primate or animal sources)

> 1\. Where will this work be performed? Building \# \_\_\_\_\_ Room \#
> \_\_\_\_\_
>
> It is the responsibility of each PI to:
>
> a\) Consult either the NIH-CDC publication entitled \"Biosafety in
> Microbiological and Biomedical Laboratories\":
> <http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm> **or** search
> the catalog at\
> the American Type Culture Collection web-site: <http://www.atcc.org/>
>
> b\) Identify the Biosafety Level for each specimen.

  ----------------- ------------- --------------- ------------------------
  **Specimen**      **Species**   **Biosafety     **How
                                  Level**         Inactivated/disposed**

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  
  ----------------- ------------- --------------- ------------------------

> 2\. If your research involves the use of non-human primate blood, body
> fluids, organs or tissues, are all laboratory personnel familiar with
> OHSA\'s \"Bloodborne Pathogen Regulations\" and have all personnel
> completed Bloodborne Pathogen Training?

**\[ \]** Yes **\[ \]** No **\[ \]** NA

[**For all specimens greater than Biosafety Level 1**, please answer
questions 3-10]{.underline}

> 3\. Name of specimen(s) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> 4\. Largest volume of specimen used is: \_\_\_\_\_\_\_Liter(s)
>
> Concentration: \_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> 5\. Specify methods of specimen concentration (if applicable)
>
> **\[ \]** Centrifugation: **\[ \]** Precipitation:
>
> **\[ \]** Filtration: **\[ \]** Other:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> 6\. Specify methods of specimen inactivation:
>
> **\[ \]** Heat **\[ \]** Chemical **\[ \]** Radiation
>
> **\[ \]** Other: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> 7\. How is inactivated material disposed?
>
> 8\. What [containment equipment]{.underline} is available? (Check all
> that apply.)
>
> **\[ \]** Biological Safety Cabinet: **\[ \]** Class I **\[ \]** Class
> II **\[ \]** Class III\
> Date of Last Certification:
> [\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}
>
> **\[ \]** Chemical Fume Hood **\[ \]** Containment Centrifuge
>
> **\[ \]** Centrifuge **\[ \]** Other:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> 9\) What methods will be employed to monitor the health and safety of
> personnel involved in this research?
>
> 10\) If there is evidence of exposure, what course of action will be
> taken?

**\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--**

**G.** **[Physical agents]{.underline}** (UV light, lasers,
radio-frequency or microwaves, electricity, trauma)**\
**(attach brochure if appropriate)

[Describe]{.underline}:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--**

**H.** **[Animals]{.underline}** - If this item is checked, you must
have a new or approved Animal Component of Research Protocol (ACORP)
form. [Please attach your ACORP application form:]{.underline}

[Species]{.underline}:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

> 1\) Will animals be exposed to Hazardous Agents (radiation,
> biological, chemical, recombinant DNA, etc) and returned to VMU
> housing?
>
> \[ \] Yes \[ \] No, **If Yes, please answer the following:**
>
> a\) Identify the agent:
>
> -\>
>
> b\) How will the animal be exposed?\
> -\>
>
> c\) Is special housing required once the animal is exposed?\
> -\>
>
> d\) How is the agent excreted from the animal?\
> -\>
>
> e\) Will the animal be infective to other animals or humans?\
> -\>
>
> f\) If the animal is infective, how many days before it will be
> non-infective? \_\_\_\_\_\_\_\_\_\_\_\_

**\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--**

**I. [Controlled Substances]{.underline}**

> 1\. List the controlled substance(s) that will be used in your
> research\
> (Refer to the Schedule of Controlled Substances web site.)
>
> <http://www.deadiversion.usdoj.gov/schedules/schedules.htm>

  ---------------------------------------------- ------------------------
  **Controlled Drug Name**                       **Are Scheduled drugs\\
                                                 stored in a
                                                 double-locked vault?
                                                 (Yes/No)**

                                                 

                                                 

                                                 

                                                 
  ---------------------------------------------- ------------------------

**J. [Staff Training]{.underline}:** With regard to any of the potential
hazard categories identified on page 1, describe the training that will
be provided for each safety hazard to laboratory staff in:

Building \# \_\_\_\_\_\_\_\_\_\_\_\_\_\_ Room \# \_\_\_\_\_\_\_\_\_

> **(1) Coordination with facility safety officials:**
>
> **(2) The practices and techniques required to ensure safety:**
>
> **(3) The procedures for dealing with accidents:**

***\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--DELETE THIS HINT SECTION IN FINAL
APPLICATION\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--***

**Helpful Hints for Answering Section J, Staff Training**

These are some suggestions for addressing the Laboratory Staff Training
portion of the Subcommittee on Research Safety Form. These are only
guidelines. You must appropriately address safety as related to
procedures conducted in conjunction with your research program.

> **(1) Coordination with facility safety officials:**
>
> You must address training (new employee, annual safety training
> update, new employee and annual radiation safety training, infection
> control training, veterinary medical unit training, lab specific
> training). If your lab is located at the University, address
> coordination and safety training which takes place at the University.
>
> **(2) The practices and techniques required to ensure safety:**
>
> Make sure to address each of the components you checked off on page 1,
> for example, human tissue/sample, animals, radioisotopes, microbial
> agents, chemicals, recombinant DNA, etc.
>
> Sample:
>
> General lab safety procedures are practiced at all times.
>
> Hazardous chemicals are used in a properly vented hood, safety glasses
> & gloves are worn when necessary.
>
> MSDS sheets are available for all chemicals.
>
> Radiation monitoring is carried out as directed by Radiation Safety
> Officer. (if appropriate)
>
> Cell culture work is carried out in certified laminar flow hoods.
>
> Standard precautions are followed.
>
> Be aware of the policies and procedures outlined in the Safety
> Policies Handbook Binder which must be in each VA lab.
>
> **(3) The procedures for dealing with accidents:**
>
> Describe how you will follow the procedures for dealing with accidents
> and you will follow instructions as outlined in the Safety Policy
> Handbook: You must cite the appropriate policies listed here.
>
> MSDS sheets for hazardous chemicals
>
> Radiation Safety Program Handbook (if appropriate)
>
> S-1, Radiation Safety Committee and the ALARA Program
>
> S-2, Hazardous Materials Management S-3, Safety Management Program
>
> S-4, Exposure Control Plan S-5, Emergency Preparedness Program
>
> Blood Spill Clean-Up In The Research Facility (8-17-06)
>
> 119-6, Hazardous Drug Safety & Health Plan: Preparation,
> Administration and Disposal of Cytotoxic Agents
>
> VHA Handbook 1200.06, Control of Hazardous Agents in VA Research
> Laboratories (10-21-05)
>
> (Please cite other appropriate policies and procedures)

***\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--DELETE THIS HINT SECTION IN FINAL
APPLICATION\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--***

**PRINCIPAL INVESTIGATOR ACKNOWLEDGEMENT OF RESPONSIBILITY**

I certify that my research studies will be conducted in compliance with
and full knowledge of Federal, State, and local policies, regulations,
and CDC-NIH Guidelines governing the use of, biohazardous materials,
chemicals, radioisotopes, and physical hazards. I further certify that
all technical and incidental workers involved with my research studies
will be aware of potential hazards, the degree of personal risk (if
any), and will receive instructions and training on the proper handling
and use of biohazardous materials, chemicals, radioisotopes, and
physical hazards. A chemical inventory of all Occupational Safety and
Health Administration (OHSA) and Environmental Protection Agency
(EPA)-related hazardous chemicals is attached to this survey.

Principal
Investigator\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**CERTIFICATION OF SAFETY OFFICER'S APPROVAL**

A complete list of chemicals to be used in the proposal has been
reviewed. Appropriate occupational safety and health, environmental, and
emergency response programs will be implemented on the basis of the list
provided.

**CERTIFICATION OF PROPOSAL APPROVAL**

The safety information for this application has been reviewed and is in
compliance with Federal, State, and local policies, regulations, and
CDC/NIH Guidelines governing the use of biohazardous materials,
chemicals, radioisotopes, and physical hazards. Copies of any additional
surveys used locally are available from the Research Office.

Chair,

R&D Committee:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Chair, Subcommittee

on Research Safety:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Radiation

Safety Officer:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

(If applicable)

Facility Safety Officer/

Industrial Hygienist:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**October 21, 2005 VHA HANDBOOK 1200.06**

**APPENDIX A**

**HAZARDOUS BIOLOGICAL AND CHEMICAL AGENTS**

1\. The Centers for Disease Control and Prevention (CDC) has identified
certain biological, chemical and radioactive materials or agents as
having potential for use as weapons by terrorists. Improper use and/or
containment of these materials or agents pose a risk to national
security because of their:

a\. Ease of dissemination or transmittal between individuals;

b\. Potential for high mortality rates and major public health impact;

c\. Potential for causing public panic and social disruption; and

d\. Risk for public health preparedness.

**2. Storage and/or use of these materials or agents in any quantity in
a Department of Veterans Affairs (VA) research laboratory requires
special consideration for physical security, personnel access, inventory
control, and emergency preparedness. These include:**

a\. [Select Agents and Toxins]{.underline}. A current list of select
agents and toxins may be found at
[http://www.CDC.gov/od/sap.](http://www.CDC.gov/od/sap) This site also
includes agents and toxins that are included on the United States
Department of Agriculture (USDA) list of biological agents and toxins
that overlap with the CDC list. This website contains:

\(1\) A list of toxin [amounts]{.underline} (exempt quantities)
permissible for an investigator to store or use without requiring
compliance with Title 42 Code of Federal Regulations (CFR) 73; and

\(2\) A list of agents and toxins that have been excluded from the list
of select biological agents and toxins.

b\. [List of USDA Biologic Agents and Toxins.]{.underline} A list of
USDA biologic agents and toxins may be found at:
<http://www.aphis.usda.gov/>[.]{.underline}

c\. [Chemical Agents Considered to be Hazardous Agents.]{.underline} The
following chemicals are considered hazardous agents. *NOTE: This list
may be updated in the future and updates will be found on the Office of
Research and Developments website:
[[http://vaww1.va.gov/resdev/]{.underline}](http://vaww1.va.gov/resdev/).*

**HHS AND USDA SELECT AGENTS AND TOXINS\
7 CFR Part 331, 9 CFR Part 121 and 42 CFR Part 73**

**HHS SELECT AGENTS AND TOXINS**

Abrin

Cercopithecine herpesvirus 1 (Herpes B virus)

*Cocciciioides posadasif*

Conotoxins

Crimean-Congo haemorrhagic fever virus

Diacetoxyscirpenol

Ebola virus

Lassa fever virus

Marburg virus

Monkeypox virus

Reconstructed replication competent forms of the 1918 pandemic influenza
virus containing any portion of the coding regions of all eight gene
segments

Ricin

*Rickettsia* prowazekll

*Rickettsia* rickettsii

Saxitoxin

Shiga-like ribosome inactivating proteins

South American Haemorrhagic Fever viruses

Flexal Guanarito

Junin Machupo

Sabia

Tetrodotoxin

Tick-borne encephalitis complex (flavi) viruses

Central European Tick-borne encephalitis

Far Eastern Tick-borne encephalitis

Kyasanur Forest disease

Omsk Hemorrhagic Fever

Russian Spring and Summer encephalitis

Variola major virus (Smallpox virus)

Variola minor virus (Alastrim)

Yersinia pestis

**OVERLAP SELECT AGENTS AND TOXINS**

*Bacillus anthracis*

Botulinum neurotoxins

Botulinum neurotoxin producing species of *Ciostrid/um*

*Brucella abortus*

*Brucella melitensis*

*Brucella suis*

*Burkholderia* mai!ei (formerly *Pseudomonas mallei)*

*Burkholderia pseudornallei* (formerly Pseudomonas *pseudoma f/el)*

*Clostridium perfringens* epsilon toxin

Coccidio/des *immitis*

Coxieifa *burnetii*

Eastern Equine Encephalitis virus

*Francisella tularensis*

Hendra virus

Nipah virus

Rift Valley fever virus

Shigatoxin

Staphylococcal enterotoxins

T-2 toxin

Venezuelan Equine Encephalitis virus

**USDA SELECT AGENTS AND TOXINS**

African horse sickness virus

African swine fever virus

Akabane virus

Avian influenza virus (highly pathogenic)

Bluetongue virus (Exotic)

Bovine spongiform encephalopathy agent

Camel pox virus

Classical swine fever virus

> *Cowdria ruminantium* (Heartwater)

Foot-and-mouth disease virus

Goat pox virus

Japanese encephalitis virus

Lumpy skin disease virus

Malignant catarrhal fever virus

(Alcelaphine herpesvirus type 1)

Menangle virus

> *Mycopiasma capricolumi MF381M. mycoides Capri* (contagious caprine
> pleuropneumonia)

Mycoplasrna mycoides rnycoides

(contagious bovine pleuropneumonia)

Newcastle disease virus (velogenic)

Peste des petits ruminants virus

Rinderpest virus

Sheep pox virus

Swine vesicular disease virus

Vesicular slornatitis virus (Exotic)

**USDA PLANT PROTECTION AND QUARANTINE (PPQ)**

**SELECT AGENTS AND TOXINS**

*Candidatus Liberobacter africanus*

*Cand/datus Liberobacter asiaticus*

> *Peronosclerospora philippinensis*
>
> *Ralstonia solanacearum race 3, biovar 2*
>
> *Schlerophthora rayssiae var zeae*
>
> *Synchytrium endobioticum*
>
> *Xanthornonas oryzae.pv. oryzicola*

*Xylella fastidiosa* (citrus variegated chlorosis strain)

**Chemical Agents Considered to be**

**Hazardous Agents by VA ORD *10/21/05***

> \(1\) 3-quinuclidinyl benzilate (BZ);
>
> \(2\) Chlorine gas;
>
> \(3\) Cyanogen chloride (OK);
>
> \(4\) Cyclosarin (GF);
>
> \(5\) Diphosgene (OP);
>
> *(6)* Hydrogen cyanide (AC);
>
> *(7)* Lewisite (L); *L-1, L-2, and L-3*
>
> \(8\) Lysergic acid diethylamide (LSD);
>
> \(9\) Nitrogen mustard (HN-1, HN-2, or HN-3);
>
> \(10\) Phosgene (CG), also known as carbonyl chloride;
>
> \(11\) Phosgene oxime (CX);
>
> \(12\) Sarin (GB);
>
> \(13\) Soman (GD);
>
> \(14\) Sulfur mustard (H, HD, or hIT), also called mustard gas or
> mustard agents;
>
> \(15\) Tabun (GA); and VX (name and symbol).
>
> Table 1. Summary of Recommended Biosafety Levels for Infectious Agents

[Click this link for the full CDC Guidebook]{.underline}:
<http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm>

+----+-------------+------------+----------------------+-------------+
| #  | **Agents**  | **P        | **Safety Equipment** | **F         |
|  * |             | ractices** |                      | acilities** |
| *B |             |            | **(Primary           |             |
| SL |             |            | Barriers)**          | *           |
| ** |             |            |                      | *(Secondary |
|    |             |            |                      | Barriers)** |
+----+-------------+------------+----------------------+-------------+
| *  | Not known   | Standard   | None required        | Open bench  |
| *1 | to          | Micro      |                      | top sink    |
| ** | c           | biological |                      | requireda   |
|    | onsistently | Practices  |                      |             |
|    | cause       |            |                      |             |
|    | disease in  |            |                      |             |
|    | healthy     |            |                      |             |
|    | adults      |            |                      |             |
+----+-------------+------------+----------------------+-------------+
| *  | Associated  | BSL-1      | Primary barriers =   | BSL-1 plus: |
| *2 | with human  | practice   | Class I or II BSCs   |             |
| ** | disease,    | plus:      | or other physical    | Autoclave   |
|    | hazard =    |            | containment devices  | available   |
|    | p           | Limited    | used for all         |             |
|    | ercutaneous | access     | manipulations of     |             |
|    | injury,     |            | agents that cause    |             |
|    | ingestion,  | Biohazard  | splashes or aerosols |             |
|    | mucous      | warning    | of infectious        |             |
|    | membrane    | signs      | materials; PPEs:     |             |
|    | exposure    |            | laboratory coats;    |             |
|    |             | \"Sharps\" | gloves; face         |             |
|    |             | p          | protection as needed |             |
|    |             | recautions |                      |             |
|    |             |            |                      |             |
|    |             | Biosafety  |                      |             |
|    |             | manual     |                      |             |
|    |             | defining   |                      |             |
|    |             | any needed |                      |             |
|    |             | waste      |                      |             |
|    |             | decon      |                      |             |
|    |             | tamination |                      |             |
|    |             | or medical |                      |             |
|    |             | su         |                      |             |
|    |             | rveillance |                      |             |
|    |             | policies   |                      |             |
+----+-------------+------------+----------------------+-------------+
| *  | Indigenous  | BSL-2      | Primary barriers =   | BSL-2 plus: |
| *3 | or exotic   | practice   | Class I or II BCSs   |             |
| ** | agents with | plus:      | or other physical    | Physical    |
|    | potential   |            | containment devices  | separation  |
|    | for aerosol | Controlled | used for all open    | from access |
|    | tr          | access     | manipulations of     | corridors   |
|    | ansmission; |            | agents; PPEs:        |             |
|    | disease may | Decon      | protective lab       | Se          |
|    | have        | tamination | clothing; gloves;    | lf-closing, |
|    | serious or  | of all     | respiratory          | double-door |
|    | lethal      | waste      | protection as needed | access      |
|    | c           |            |                      |             |
|    | onsequences | Decon      |                      | Exhausted   |
|    |             | tamination |                      | air not     |
|    |             | of lab     |                      | r           |
|    |             | clothing   |                      | ecirculated |
|    |             | before     |                      |             |
|    |             | laundering |                      | Negative    |
|    |             |            |                      | airflow     |
|    |             | Baseline   |                      | into        |
|    |             | serum      |                      | laboratory  |
+----+-------------+------------+----------------------+-------------+
| *  | Dange       | BSL-3      | Primary barriers =   | BSL-3 plus: |
| *4 | rous/exotic | practices  | All procedures       |             |
| ** | agents      | plus:      | conducted in Class   | -           |
|    | which pose  |            | III BSCs or Class I  |    Separate |
|    | high risk   | Clothing   | or II BSCs [in       |             |
|    | of          | change     | combination          |    building |
|    | life-       | before     | with]{.underline}    |     or      |
|    | threatening | entering   | full-body,           |             |
|    | disease,    |            | air-supplied,        |    isolated |
|    | aerosol-    | Shower on  | positive pressure    |     zone    |
|    | transmitted | exit       | personnel suit       |             |
|    | lab         |            |                      | Dedicated   |
|    | infections; | All        |                      | supply and  |
|    | or related  | material   |                      | exhaust,    |
|    | agents with | deco       |                      | vacuum, and |
|    | unknown     | ntaminated |                      | decon       |
|    | risk of     | on exit    |                      | systems     |
|    | t           | from       |                      |             |
|    | ransmission | facility   |                      | Other       |
|    |             |            |                      | r           |
|    |             |            |                      | equirements |
|    |             |            |                      | outlined in |
|    |             |            |                      | the text    |
+----+-------------+------------+----------------------+-------------+