The movement of animals, their tissues or body fluids from the animal colony to the research laboratory or within the animal colony is a research necessity. This creates the possibility for the introduction of agents which could be potentially pathogenic to the animal colony or laboratory workers using these animals.

Thus this safety policy is a precautionary measure to help prevent unwarranted infections;

• Zoonotic, i.e., lymphocytic choriomeningitis virus
• Cross-contamination, experimental laboratory or natural occurring animals, i.e., hantan virus
• Exposure to users to intermediate or final products that are physiologically active, which even minute quantities of some may cause medically significant side effects, i.e., experimental drugs and
• Allergic reactions due to sensitization to proteins and peptides generated during the course, i.e., dander.

The following must be adhered to when work involves movement of materials from the tissue culture laboratory to the animal colony:

1. Approval from BOTH the Biological Safety Officer/Institutional Biosafety Committee (IBC) and the Compliance Officer/Institutional Animal Care and Use Committee (IACUC).

• Complete a BSP-2 form for the IBC and a Animal Transfer Form for LAS. Remember to always purchase tissue or cell cultures from reputable vendors and have current Antibody Production Test results available.

• Write a memo outlining intended tissue culture use to IACUC.

  NOTE: If your activities are solely analytical and involve only the analysis of animal tissues and blood that are provided by someone else you are not required to complete an application (Vertebrate Animal Use form). The PI should provide documentation in the form of a letter or memorandum to explain the nature and purpose of the research activity. Included in the letter should be the type of samples, place of origin, and species of vertebrate animal. If there are no concerns, you will obtain a waiver (exemption) for the projects activities from full IACUC committee review.

  Please be advised that the Biosafety Program and the IACUC Compliance Officer has in place a joint policy regarding this type of request to ensure that samples are not brought in that contain biological hazards and/or organisms that are considered zoonotic.

Send your Memo/letter/email regarding your research and intended use of __________ cultures to:
Norman Magno UH Regulatory compliance Officer Executive Secretary, UH IACUC	Snyder Hall 410 Phone: 956-4446 Email: nmagno@hawaii.edu

2. Adhere to Biosafety Level 2 practices and techniques when actively manipulating any animal tissues, body fluids or cell cultures.

   Work should be performed in a certified Biological Safety Cabinet (BSC) and not in a Laminar Flow Clean Benches (LFCB) which does not protect the user against potential contaminates which may be inadvertently aerosolized.

3. Personnel working with mammalian tissue or cell cultures should have no contact with susceptible animal species.

   A 24-hour quarantine period (no contact with live animals). If this cannot be avoided, hands should be washed, and fresh personnel protective equipment (laboratory coats, gloves, safety goggles and respirator) should be put on. PPE should be changed prior to entering the colony and after exiting the laboratory.

4. Decontaminate all contaminated (infectious, biologically contaminated) waste by autoclaving prior to washing or disposal.

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The import or purchase of any vertebrate animal antibodies, sera and/or animal parts, including pregnant mare urine must be from "registered" and "licensed" dealers.

Any regulated commodities used for research, teaching, testing or experimentation require a dealer's license in addition to its registration prior to procurement. This is to comply with federal Animal Welfare Act, including:

1. Animals involved in custom antibody production will be maintained and used in accord with federal humane standards.

2. Antibody production will be conducted in a manner that is scientifically reliable.

3. Compliance burdens to investigators and institutions will be minimized.

When procuring these commodities from non-institutional sources:

1. Contact the proposed producer to determine it's Assured status, and if Assured obtains the Assurance number (registration/license number). Alternatively, consult with Office for Laboratory Animal Welfare (OLAW) for information on the Assured status of the preferred commodity producer. If the producer is Assured, the procurement action may proceed without additional actions.

2. If the producer is not Assured, at least two options are available:
   1. Commodities may be procured from other producers that are Assured; or

   2. The producer or the applicant organization may requests that OLAW negotiate an Assurance with the producer's organization.

3. Some vendors are not producers, thus a Food and Drug Administrative (FDA) License number will be sufficient, instead of the OLAW and USDA licenses.

   Approval from both the Biological Safety Officer/Institutional Biosafety Committee (IBC) and the Compliance Officer/Institutional Animal Care and Use Committee (IACUC). Include OLAW registration number and USDA Facility's license number.

   • IBC -Complete a BSP-2, include both numbers.

   • IACUC - written memo on official letterhead, include brief description, use and both numbers.

   • LAS - Complete a LAS - Animal Transfer Form.

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1. Biological Safety Program (BSP) receives inquires.

2. Form requirements:
   1. Complete a "Procurement Authorization for Biological Commodities," (BSP-2 form - http://www.hawaii.edu/ehso/bio/bsp2rf.pdf).

   2. Submit an "Animal Transfer Form" to Laboratory Animal Service (LAS) http://www.hawaii.edu/ehso/bio/AnimalTrans.pdf and

   3. Memo to Institutional Animal Care and Use Committee (IACUC) for reasons needing and using biological material as defined in flyer (http://www.hawaii.edu/ehso/bio/animal1.htm)

3. Institutional Biosafety Committee (IBC) authorizes BSP-2 form, once laboratory is inspected to meet minimum risk level, training is documented, permits if any are obtained,

4. Authorized BSP-2 form is faxed via LAS to UH Veterinarian's Office.

5. UH Veterinarian's Office reviews for LAS specific requirements, i.e. Possible zoonotic diseases or disease transmission to animal colony.

6. BSP-2 form with IBC and UH veterinarian's authorization is forward to the UH Compliance Office on behalf of IACUC to determine whether the use of biological commodities such as, but not necessarily limited to polyclonal and monoclonal antibodies, cell lines, tissue, fluid, serum and blood products of/or derived from vertebrate animal origin may be exempt from IACUC protocol review from full IACUC protocol review and/or other regulatory procedures (http://www.aphis.usda.gov/ac/policy/policy10.pdf)

7. The IACUC committee Chair or Designee and the Compliance office will determine whether the use of the biological commodities is exemptable.

   Exemption or other requirements are communicated in writing to the PI with copies to UH Veterinarian's office and IBC.

8. BSP notifies PI with original copies of BSP-2 to PI, that all requirements have been met and import is approved.

9. For more information please either call:
   1. Biological Safety Program at 956-3197/8009 or http://www.hawaii.edu/ehso/bio or biosafe@hawaii.edu,

   2. UH Veterinarian at 956-4446 or sylviak@hawaii.edu or

   3. IACUC Compliance Office at 956-4446/4552 or nmagno@hawaii.edu or deniseye@hawaii.edu

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Drosophila - Fruit Flies Import/Interstate Transport

All shipments of Drosophila fruit flies into the United States (including Territories) from foreign sources must now be pre-authorized with a Plant Pest Permit (PPQ Form 526). Interstate shipments among States in continental North America (including Alaska) do not require Plant Pest Permits, but interstate shipments to and from Hawaii and the Territories do require permits. Although Drosophila fruit flies present minimal plant pest risk (e.g., feeding on overripe fruit in storage), shipments manifested as fruit flies have recently raised agricultural and environmental concerns because this common name also refers to notoriously significant plant pests like the Mediterranean and oriental fruit flies. As a result, plant pest permits are now required so that shipments are appropriately routed to PPQ inspection stations for confirmation of the identities of the enclosed organisms. Permits and the appropriate use of shipping labels will facilitate movement through Customs and Border Protection inspection processes with minimal delays in PPQ inspection stations.

http://www.aphis.usda.gov/ppq/permits/plantpest/howtoapply.html

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ANIMAL PATHOGENS (Hawaii Specific)

When importing, possessing or manipulating these animal pests it will require an USDA permit, besides a Hawaii Department of Agriculture permit.

USDA Regulated Pathogens (Hawaii)

Foot and Mouth disease Vesicular stomatitis Swine vescular disease Rinderpest Peste des petis ruminants Contagious bovine pleuropneumonia (Mycoplasma mycoides mycoides) Lumpy skin disease Rift valley fever Bluetongue Sheep pox Goat pox African horse sickenss African swine fever Classical swine fever (hog cholera) Highly pathogenic avian influenza Newcastle disease (exotic) Anthrax (Bacillus anthracis) Aujeszky disease (psuedorabies) Echinococcosis/hydatidosis Heartwater (Cowdria runinantium) Leptospirosis Paratuberculosis (Johne's disease) (Mycobacterium avium paratuberculosis) Q fever (Coxiella burnetti) Rabies Screwworm, new world (Cochliomyia hominivorax) Screwworm, old world (Chrysomya bezziana) Cattle Disease Bovine anaplasmosis (Anaplama marginale, A. centrale) Bovine babesiosis (Babesia bovis, B. bigemina) Bovine brucellosis (Brucella abortus) Bovine genital camplobacteriosis (Camplylobacter fetus venerealis) Bovine spongiform encephalopathy Bovine tuberculosis (Mycobacterium bovis) Cysticercosis (Cysticercus bovis metacestode state of Taenia saginata) Dermatophilosis (Dermatophilus conglensis) Enzootic bovine leukosis Haemorrhagic septicaemia (Pasteurella maltocida) Infectious bovine rhintracheitis/infectious pustular vulvobaginitis Malignant catrrhal fever Theileriosis (Theileria annulata, T. parva) Trichomonosis (Tritrichomonas foetus) Trypanosomosis (tsetse borne) Sheep and Goat Disease Ovine epididymitis (Brucella ovis) Caprine and ovine brucellosis (Brucella melitensis) Contagious agalactia (mycoplasma sp.) Conagous caprine pleuropneumonia (M. capricolum capripneumoniae) Enzootic abortion of ewes (Chlmaydia psittaci) Ovine pulmonary adenomatosis Nairobi sheep disease Salmonellosis (Salmonella abortus ovis) Scrapie Maedi-visna      Equine diseases Contagious equine netritis (Taylorella equigenitalis) Dourine (trypanosoma equiperadum) Epizootic lymphangitis (Histoplasma farcininosum) Equine viral arteritis Equine encephalomyelitis (Eastern and Western) Equine encephalomyelitis (Venezuelan) Equine infectious anemia Equine influenza (Virus Type A)

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