IV. Laboratory Procedures and Equipment

A. Guidelines for Good Laboratory Practices at BSL1 and BSL2*

(Excerpted from the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories and the NIH Guidelines for Research Involving Recombinant DNA Molecules)

*Indented and bulleted items indicate additional requirements for work at BSL2.

1. Immediately notify the laboratory supervisor or Principal Investigator (PI) in case of an accident, injury, illness, or overt exposure associated with laboratory activities. As appropriate, proceed to McCosh Health Center for any necessary medical surveillance and/or treatment. Note: The University is required to report to regulatory officials any significant research-related accidents/injuries and violations of NIH Guidelines so it is important that the lab notify the Office of Research and Project Amniistration (OPRA), Institutional Biosafety Committee (IBC) immediately under such circumstances.

2. For those intending to work with live viruses or research animals: complete the Live Virus Worker and/or the Animal Worker web-based training (See http://web.princeton.edu/sites/ehs/biosafety/livevirusworker/intro.htm or http://web.princeton.edu/sites/ehs/biosafety/animalworker/intro.htm) and the required medical review with Employee Health at McCosh Health Center. For live virus work, serum draw and titering may be required or desired depending on the virus involved. (See more information at
http://www.princeton.edu/sites/ehs/biosafety/livevirusworker/lvprograminfo.htm or http://web.princeton.edu/sites/ehs/biosafety/biosafetypage/animal.htm).

3. For those intending to work with blood or human tissue: complete the Protection Against Bloodborne Pathogens web-based training and entry into the Bloodborne Pathogens Program. (See http://web.princeton.edu/sites/ehs/biosafety/bloodpathogens/Training/BBPIntro.htm )

4. Be aware that access to the laboratory is limited or restricted at the discretion of the laboratory director when experiments or work with cultures or specimens is in progress. Laboratory should have doors to control access.

5. Understand that the PI and/or lab supervisor must ensure that all laboratory personnel receive appropriate initial training, necessary on-going training, and supervision regarding on hazards associated with the agents involved; the necessary precautions to prevent exposures; and exposure evaluation procedures.

6. Understand that personal health status may impact an individual’s susceptibility to infection or necessary medical surveillance and any conditions in this regard should be discussed with lab supervisor and healthcare personnel in Health Services as appropriate.

• Only personnel advised of the special hazards and meeting any specific entry requirements, i.e., appropriate immunizations, serum sampling, are permitted in the laboratory. Understand and follow all biosafety procedures provided by the PI and/or supervisor.
• Be aware that any possession or use of select biological agents or toxins requires special federal government registration and inspection; restricted lab access; written and strictly followed safety and security plans; personnel background checks and training; accurate records and/or reporting of agent use, transfer, loss, or destruction. Any plans for obtaining such materials must be discussed with the Biosafety Officer and approved by the IBC.
• Ensure that when infectious agents are in use in the laboratory, a biohazard sign is posted on the lab access door. This sign identifies the agent(s) in use, the biosafety level, any required immunizations, the PI’s name and telephone number, and any PPE that must be worn in the laboratory.

7. Wash hands frequently and always after handling viable material or animals, after removing gloves, and before leaving the laboratory. A sink for handwashing is present in each laboratory.

• Consider foot, knee, or automatically operated handwashing sinks.
• Know the location of a readily accessible eyewash station.

8. Do not eat, drink, smoke, chew gum, handle contact lenses, or apply cosmetics in the laboratory. Persons wearing contact lenses in the laboratory should also wear goggles or a face shield.

9. Do not bring any food, medications, or cosmetics, into the laboratory for storage or later use. Food is stored outside the work area in cabinets or refrigerators designated specifically for that purpose.

• Do not bring animals unrelated to experimental work into the laboratory.

10. Do not pipette by mouth; only mechanical pipetting devices are permitted.

11. Perform all procedures carefully to minimize the creation of splashes or aerosols.

12. Establish and follow policies for safe handling of sharps. Use a high degree of caution when handling any contaminated sharp item, such as needles and syringes, slides, pipettes, capillary tubes, and scalpels. Substitute plasticware for glass whenever possible. Handle broken glassware with brush and dustpan, tongs, or forceps - not directly with hands.

13. Do not bend, shear, break, recap, or remove used needles from disposable syringes or otherwise manipulate such units by hand before disposal. Dispose of needles and syringes in the puncture resistant container provided in the laboratory for this purpose. Place full containers in an autoclave bag and sterilize before disposal in medical waste boxes.

• Restrict needles and syringes or other sharp instruments in the laboratory for use only when there is no alternative, such as for parenteral injection, phlebotomy, or aspiration of fluids from laboratory animals and diaphragm bottles.
• Use only needle-locking syringes or disposable syringe-needle units (i.e., needle is integral to the syringe) for injection or aspiration of infectious material.

14. Use of lab coats, gowns, or other designated laboratory uniform is recommended to prevent contamination or soiling of street clothing.

• Wear lab coats, gowns, smocks, or other provided protective garments while working with hazardous materials. When leaving the lab, remove and leave coats and other protective clothing in the lab for either disposal or laundering.

15. Wear gloves if the skin on the hands is broken or if a rash is present. Protective eyewear should be worn for procedures that involve anticipated splashes of microorganisms or other hazardous materials to the face.

• Wear gloves when manipulating infectious materials or agents or when hands must otherwise contact contaminated surfaces. Remove and change gloves when overtly contaminated or when torn or punctured. Do not wear contaminated gloves outside the lab. Do not wash or reuse disposable gloves. Consider alternatives to latex gloves to prevent allergic response.
• Wear appropriate face protection (goggles, mask, face shield or other splatter guard) for anticipated splashes or sprays of infectious materials to the face when agents must be handled outside the BSC. Persons wearing contact lenses should also wear eye protection.

16. Decontaminate equipment and work surfaces at completion of work, at the end of the day, and following spills of viable materials. If a spill occurs, cover the spill with paper towels and soak the towels with a 1 to 10 dilution of chlorine bleach or other suitable disinfectant. Allow the material to soak for approximately 20 minutes before discarding materials in biohazard bag. Bench tops are impervious to water and resistant to solvents, acids, alkalis, and chemicals used for surface decontamination. Laboratory surfaces and spaces between fixtures are designed to be easily cleaned; no carpets or rugs.

17. Work on open bench tops is permitted; use of special containment equipment such as a biological safety cabinet (BSC)is not generally required for agents assigned to BL1.

• Work in the open laboratory is permitted, except that a properly maintained biological safety cabinet is required whenever:

Procedures with a potential for creating infectious aerosols or splashes are conducted. These may include centrifuging, grinding, blending, vigorous shaking or mixing, sonic disruption, opening containers of infectious materials whose internal pressures may be different from ambient pressures, inoculating animals intranasally, and harvesting infected tissues from animals or embryonate eggs.

 High concentrations or large volumes of infectious agents are used . Such materials may be centrifuged in open laboratory if sealed rotor heads or centrifuge safety cups are used, and if these rotors or safety cups are opened only in a biological safety cabinet.

Be aware that air sampling studies have shown that most of the common manipulations of bacterial and viral cultures in research laboratories release aerosols of viable organisms. This must be considered when evaluating need for use of the biological safety cabinet or other physical containment device.

18. Dispose of all regulated medical wastes (potentially biohazardous) and associated wastes as outlined in the provided Laboratory Waste Streams charts developed for all laboratories using biological materials (see http://web.princeton.edu/sites/ehs/biosafety/biosafetypage/disposalchart.htm)and for Chemistry and other departments where some labs use biological materials (see http://web.princeton.edu/sites/ehs/biosafety/biosafetypage/disposalchart2.htm).

• Cover containers of all cultures, tissues, specimens of body fluids, or other potentially infectious waste to prevent leakage during collection, handling, processing, storage, transport, or shipping.

19. Have an insect and rodent control program in place. Ensure screens are fitted on exterior windows that open into the lab.

Revised 9/07

B. Biological Safety Cabinets (BSCs) (top)

Types of BSCs

BSCs are classified as Class I, Class II or Class III cabinets. When properly maintained and operated, they effectively contain and capture microbial contaminants and infectious agents using HEPA (High Efficiency Particulate Air) filters. (See Figure 1.) Biosafety cabinets should not be confused with clean benches which only protect the material being worked with and are not suitable for work with infectious or toxic material. (Although clean benches, like BSCs, have HEPA-filtered air, with clean benches the air flows over the experimental material toward the user rather than being drawn away.) BSCs should also not be confused with conventional fume hoods that do not filter microorganisms.

Class I BSCs provide personnel and environmental protection, but not product protection. (See Figure 2).

Class II BSCs are the most commonly used BSC on campus. These cabinets provide personnel, environmental and product protection. (See Figure 3). Only those which are hard ducted to the outside and provide a face velocity of 80 to 125 feet per minute should be used when working with volatile chemicals. Additionally, cabinets are not designed to prevent ignition of volatile flammable chemicals.

Working in a BSC

1. Turn the cabinet on for at least 10 - 15 minutes prior to use, if the cabinet is not left running.
   
2. Disinfect work surface with 70% alcohol or other suitable disinfectant.
   
3. Consider the materials necessary for the planned work in the cabinet.
   
4. Place items into the cabinet so that they can be worked with efficiently without unnecessary disruption of the air flow, working with materials from the clean to the dirty side.
   
5. Wear appropriate personal protective equipment. At a minimum, this will include a buttoned laboratory coat and gloves.
   
6. Adjust the working height of the stool so that the worker's face is above the front opening.
   
7. Delay manipulation of materials for approximately one minute after placing the hands/arms inside the cabinet.
   
8. Minimize the frequency of moving hands in and out of the cabinet.
   
9. Do not disturb the airflow by covering any of the grillwork with materials.
   
10. Work at a moderate pace to prevent the air flow disruption that occurs with rapid movements.
    
11. Wipe the bottom and side of the hood surfaces with disinfectant when work is completed.

NOTE: Be very careful when using small pieces of materials such as kimwipes in the hood. These can be blown into the hood and disrupt the motor operations.

Certification of the BSC

Certification is a series of performance tests on the BSC to confirm that it will provide the user and experimental material the protection for which it is designed. The air flows, filters, and cabinet integrity are checked to ensure that the cabinet meets minimum performance standards. Certification is arranged through the department and provided by an outside vendor.

BSCs intended for user protection must be certified:

• After they are received and installed (before use with infectious materials)
  
• After filter changes
  
• Annually

Biological safety cabinets intended only for protection of the experimental material are certified at the discretion of the Principal Investigator.

BSC decontamination (using the paraformaldhyde gas production process) is also provided by an outside vendor and needs to be done:

• Before any maintenance work requiring disassembly of the air plenum, including filter replacement
  
• Prior to cabinet recertification
  
• Before moving the cabinet to a new laboratory

C. Decontamination (top)

Definitions

Decontamination is a process or treatment that renders an instrument or environmental surface safe to handle. A decontamination procedure can be as simple as clean-up with detergent and water or as thorough as sterilization. Sterilization, disinfection, and antisepsis are all forms of decontamination.

Sterilization is the use of physical or chemical processes to destroy all microbial life, including highly resistant forms, such as bacterial spores.

Disinfection is the elimination of essentially all pathogenic non-spore forming microorganisms but not necessarily all microbial forms from work surfaces and equipment. Effectiveness is influenced by a number of factors, including: types and numbers organisms; amount of organic matter; the object being disinfected; the disinfectant being used; exposure time, temperature and concentration.

Antisepsis is the application of a liquid antimicrobial to skin or other living tissue to inhibit or destroy microorganisms. Examples include hand washing with germicidal solutions or swabbing skin before an injection.

When to Decontaminate

All material and equipment contaminated with or containing potentially infectious agents should be decontaminated:

• Upon completion of procedures involving the use of biologically-active materials
  
• In the event of spills of such materials
  
• At least daily
  
• Before being washed, stored, or discarded

In most Princeton University laboratories, decontamination is accomplished by steam heat sterilization in an autoclave, or by surface application of or placement in a chemical disinfectant solution, such as 1:10 bleach solution or its equivalent.

Autoclave Use

Autoclaving (saturated steam under pressure of approximately 15 psi to achieve a chamber temperature of at least 250oF for a designated time) is the preferred and most convenient method to rapidly destroy all forms of microbial life. However, to do this, the autoclave process must reach proper temperature and time and also prevent the entrapment of air in the bag or container of treated material.

• Material to be sterilized must come into contact with live steam.
  
• Bags or containers should be left open during autoclaving or water (~200ml) should be added to sealed bags to generate steam.
  
• Heat indicator tape should be used with each autoclave load to indicate that sterilization has been completed.
  
• Autoclave sterility monitoring should be conducted on a regular basis using biological indicators (such as B. stearothermophilus spore strips) placed among treated materials and at locations throughout the autoclave. The spores, which are more resistant to heat than most microbials, provide validation of general microbial destruction when they are effectively inactivated (250 deg. F for 13 minutes) by autoclave operation.

Chemical Disinfectant Use

The most practical use of chemical disinfectants is for surface decontamination and, when used in sufficient concentration, as a decontaminant for liquid wastes prior to final disposal down the drain.

GENERAL RECOMMENDATIONS:

Liquid Decontamination

• Add liquid chlorine bleach to provide a final 1:10 dilution
  
• Let stand at least 20 minutes
  
• Discard down the drain

Surface Decontamination

• Wipe with 1:10 dilution of chlorine bleach, or
  
• Wipe with iodophor disinfectant (per label concentration), or
  
• Wipe with 70% alcohol

See Table 1, Table 2, Table 3 for further information on disinfectants.

In the event of an exposure to an infectious agent or material, the following guidelines should be used:

Intact skin

• Remove contaminated clothing
  
• Vigorously wash contaminated skin for 1 minute with soap and water

Broken, cut or damaged skin or puncture wound

• Remove contaminated clothing
  
• Vigorously wash contaminated skin for 5 minutes with soap and water
  
• Seek medical attention at McCosh Health Center

Eye

• Immediately flush eyes for at least 15 minutes with water, preferably using an eyewash; if no eyewash is available, pour water on the eye(s) for 15 minutes, rinsing from the nose outward to avoid contamination of the unaffected eye.
  
• Hold eyelids away from your eyeball and rotate your eyes so that all surfaces may be washed thoroughly.
  
• Seek medical attention at McCosh Health Center

Ingestion or Inhalation

• Seek medical attention at McCosh Health Center
  
• Do not induce vomiting unless advised to do so by a health care provider

E. Biological Material Spills (top)

Spills and Preparing for Them

In the event of a spill of biological material, the individual(s) who caused the spill is responsible for the clean-up. Princeton University does not have a spill response team.

• Minimize the consequences of any spill of biological material by performing all work on plastic-backed liner to absorb spills
  
• Have a simple spill kit on hand including:
  
  • Chlorine bleach or some other concentrated disinfectant
    
  • A package or roll of paper towels
    
  • Autoclavable bags
    
  • Rubber gloves
    
  • Forceps for pick-up of broken glass

Spills Inside a Biological Safety Cabinet

1. LEAVE THE CABINET TURNED ON
   While wearing gloves, spray or wipe cabinet walls, work surfaces, and equipment with disinfectant equivalent to 1:10 bleach solution. If necessary, flood the work surface, as well as drain pans and catch basins below the work surface, with disinfectant for a contact time of at least 20 minutes
   
2. Soak up disinfectant and spill with paper towels. Drain catch basin into a container. Lift front exhaust grill and tray and wipe all surfaces. Ensure that no paper towels or solid debris are blown into the area beneath the grill.
   
3. Autoclave all clean-up materials before disposal in the biohazard waste container. Wash hands and any exposed surfaces thoroughly after the clean-up procedure.

Small Spill of Material Outside of a Biological Safety Cabinet (Spill that can be covered by a few paper towels)

1. Wearing gloves and a lab coat, cover the spill with paper towels and gently apply disinfectant, proceeding from the outer edge of the spill to its center. Leave in place for 20 minutes.
   
2. Pick up the towels and discard into a biohazard container. Pick up any pieces of broken glass with forceps and place in sharps container.
   
3. Re-wipe the spill area with disinfectant and thoroughly wash hands after glove removal.

Large Spill of BL2 Material (>500ml) Outside of a Biological Safety Cabinet

1. Hold your breath and leave the room immediately.
   
2. Warn others to stay out of the spill area to prevent spread of contamination; post a sign stating: "DO NOT ENTER, BIOHAZARD SPILL", contact (name and phone #) for information".
   
3. Remove any contaminated clothing and put into a biohazard bag for later autoclaving.
   
4. Wash hands and exposed skin and inform your PI or supervisor about the spill
   
5. Put on protective clothing (lab coat, gloves and, if indicated, surgical mask, eye protection, shoe covers) and assemble clean-up materials.
   
6. Wait 30 minutes before re-entering the contaminated area to allow dissipation of aerosols.
   
7. Cover the spill with paper towels and gently apply disinfectant, proceeding from the outer edge of the spill to its center. Leave in place for 20 minutes
   
8. Collect all treated material and discard in a biohazard container. Pick up any broken glass with forceps and place them into a sharps container.
   
9. Re-wipe the spill area with disinfectant and wash hands thoroughly at completion of clean-up.

F. Biological Waste Handling (top)

Biohazardous Waste (Regulated Medical Waste)

Some wastes associated with biological materials must be disposed of in special ways because they may have been contaminated with infectious organisms or agents. These potentially infectious or biohazardous materials are defined by NJ regulations as Regulated Medical Waste. These wastes include the following:

• All sharps, e.g. glass implements, needles, syringes, blades, etc. coming from facilities using infectious materials
  
• Biologically-cultured stocks and plates, human blood or tissues

For disposal of these wastes, the lab personnel:

1. Sterilize or disinfect waste materials associated with viral, bacterial or other agents infectious to humans (by autoclave or chemical treatment equivalent to 1:10 bleach solution).
   
2. Place all biohazardous wastes, except for sharps, directly into the red bag-lined medical waste boxes provided by Building Services.
   
3. Place sharps into labeled sharps containers which when filled are placed into the medical waste box.
   
4. When the Medical Waste box is filled, seal the bag liner and box and notify janitor for pick-up.

   IMPORTANT LABELLING REQUIREMENT: Lab personnel must apply an adhesive-backed label completed with generator information to each bag or container (such as autoclaved bags or filled sharps containers) placed into the medical waste box. Building Services provides such a label that has space to record Date, Building, Lab #, and Contact Person. Apply this label to all containers placed inside the medical waste box AND to the exterior of the sealed medical waste box before it is made available for pick-up by Building Services. Alternatively, the inner bags and containers can be marked clearly with a permanent marker to indicate "Princeton University, Princeton, New Jersey."

5. Where pick-ups are infrequent or limited, contact Building Services to arrange for pick-up.
   

Other wastes generated in these facilities that are not contaminated with biological agents or materials are not treated as biohazardous and may be discarded in the regular trash container, with recyclables, or into other specially designated waste containers. These include such items as recyclable and non-recyclable waste glass, gloves, unused plates or tubes, fly media or embryo plates, etc.

In order to clarify how these various wastes are to be handled in laboratories using biological materials, the waste stream charts indicated below have been developed and put into use.

The chart developed for the Departments of Molecular Biology and EEB is intended to be used by biological laboratory facilities. The second chart was developed for the Chemistry Department and other science and engineering departments where biological cultures may be used in some laboratories. Choose the model that most clearly fits the waste being generated or call the Biosafety Officer at 8-5294 for clarification.

Animal Bedding Waste

This waste is picked up in a special vehicle by Princeton University Building Services personnel and is not to be mixed with other waste. All animal bedding is bagged by animal care personnel and placed in specially provided gray carts for movement to the pick-up location. Bags should be filled only to a depth and weight that will allow for effective tying of the bag by animal facility staff and for ease of handling by one person. For example, several partially-filled bags should be tied and placed in the gray carts rather than one or two full bags (bag weight should not exceed 40 pounds). This will help to prevent repetitive motion injury to staff and help to prevent bags from being ripped open while being handled.

The carts are maintained clean and in sanitary condition by the animal facility staff. Any spills of bedding when loading the truck are cleaned up by the Building Services trash crew.

Animal Carcasses

Freezers are provided in each animal facility for storage of carcasses that have been bagged and sealed. The frozen carcasses are picked up on a regular schedule for appropriate disposition - either disposal by a contracted firm or use by groups such as Raptor Trust. Freezers are cleaned and defrosted as necessary by animal laboratory personnel to keep them in a sanitary condition.

Animal Waste from BSL2 Animal Room LTL 41

Rodents housed in this animal space are considered to be potentially infectious because as part of the research protocol they are infected with Biosafety Level 2 (BSL2) animal and/or human viruses. Animal bedding, carcasses, and tissue are placed in biohazard bags by the research staff. All animal bedding is autoclaved before being placed in medical waste boxes by animal care staff and disposed of in the medical waste stream. Bagged animal carcasses and tissue are placed in the provided storage freezer in room 41 and removed by animal care staff to medical waste boxes for pick-up by Building Services as part of the medical waste stream.

Patient Care Waste Disposal

All disposable wastes generated at McCosh Health Center from patient rooms and as part of direct patient care are considered potentially infectious and are disposed of in the medical waste stream. Syringes, needles, and other sharps are placed in the provided sharps container which, when filled and sealed are placed in the provided medical waste box. When boxes are filled and sealed, they are removed by the custodial staff outside to the locked storage shed for later pick-up by Building Services.

Patient care waste generated at other sites on campus by medical response personnel (i.e. Public Safety) are placed in biohazard bags and brought to McCosh Health Center for medical waste disposal or handled by responding EMS personnel.

A program is in place to ensure that needles and syringes generated as part of personal diabetes care will not be an exposure hazard to others. Collection containers are available from McCosh Health Center which, when filled, are returned to the Health Center for proper disposal in the medical waste stream.

G. Packaging and Shipping Biological Materials (top)

Definitions

Packaging and shipping of biological materials must be done in a way that ensures the contents will not leak and that the package will arrive in good condition.

The definitions below apply to the packaging and shipping instructions that follow:

Etiologic agent means a viable microorganism or its toxin which causes, or may cause, human disease.

Diagnostic specimen means any human or animal material including, but not limited to, excreta, secretion, blood and its components, tissue, and tissue fluids, etc., which is reasonably believed to contain an etiologic agent, and is being shipped for purposes of diagnosis.

Biological product means a biological prepared and manufactured in accordance with regulations that govern the manufacture of vaccines, reagents, etc.

Interstate shipping means shipping to or from the continental US including to other NJ locations.

Packaging

All biological materials including diagnostic specimens and biological products that may contain an etiologic agent must be packaged to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling and transportation (passage through cancellation machines, sorters, conveyors, etc). Contents should not leak to the outside of the shipping container, even if leakage of the primary container occurs.

Specific packaging requirements apply to materials which are known to contain, or reasonably believed to contain certain etiologic agents. See here for etiologic agents. For such materials, the following procedures apply (See Figure 1):

Volume not exceeding 50 ml:

• Place material in a securely enclosed, watertight primary container (test tube, vial, etc.). Enclose this primary container in a secondary, durable watertight container. Several primary containers may be enclosed in a single secondary container as long as the total volume of material in all the primary containers enclosed does not exceed 50 ml.
  
• Place absorbent nonparticulate material (e.g. paper toweling, not sawdust or vermiculite, etc.) in the spaces at the top, bottom and sides between the primary and secondary containers. Use enough absorbent material to absorb the entire contents of the primary container(s) in case of breakage or leakage.
  
• Enclose each set of primary and secondary containers in an outer shipping container constructed of corrugated fiberboard, cardboard, wood or other material of equal strength. Do not use bags, envelops and similar materials.
  
• If you package the material with dry ice, see Packaging with Dry Ice.

Volume greater than 50 ml:

1. Follow requirements for lesser volumes outlined above.
   
2. Place shock absorbent material at the top, bottom, and sides between the secondary container and the outer shipping container. (This material should at least equal the amount of absorbent material placed between the primary and secondary containers).
   
3. Ensure single primary containers contain no more than 1000 ml of material; however, two or more primary containers (combined volumes not exceeding 1000 ml) may be placed in a single secondary container. The maximum amount of etiologic agent which may be enclosed within a single outer shipping container must not exceed 4000 ml.

Packaging with Dry Ice

1. If used, place dry ice between the secondary and outside containers.
   
2. Place shock absorbent material so as to prevent the secondary container from becoming loose inside the outer container as the dry ice sublimates.

Labeling

The outer shipping container of all materials containing etiologic agents which are being shipped or transported must bear a special label, as illustrated in Figure 2. These labels are available from your laboratory supply vendor.

Figure 2

Registered mail or the equivalent

For a list of etiologic agents that use registered mail or an equivalent system which provides the sender with immediate notification of receipt see here.

Federal Express or UPS

1. For such shipments, internationally or domestically, follow the International Air Transport Association (IATA) Dangerous Goods Regulations. (Receipt of shipment notice is not required since the shipment is traceable through the specific carrier).
   
2. Apply appropriate labels to the outer shipping container for packages containing dry ice and/or infectious substances as shown in Figures 3 and 4, respectively.
   
3. Contact the specific carrier's dangerous goods agent prior to shipment for any additional packaging and labeling requirements.

Damaged Packages

When evidence of leakage or any other damage to packages bearing an Etiological Agents/Biomedical Material label is discovered, the carrier must promptly isolate the package and notify the Director, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road N.E., Atlanta, Georgia 30333 or by telephone (404) 633-5313.

Notice of Delivery

In the event that a package sent by Princeton University is not received by the recipient within 5 days following the anticipated delivery of the package, the sender must notify the Director, Centers for Disease Control and Prevention, 1600 Clifton Road N.E., Atlanta, Georgia 30333 or by telephone (404) 633-5313.

Importation/Exportation of Etiologic Agents

Importation of infectious agents, etiologic agents and vectors that may contain them is governed by federal regulation. In general, an importation permit is required for any infectious agent known to cause disease to man. This includes but is not limited to bacteria, viruses, rickettsia, parasites, yeasts and molds. In some instances, an agent which is suspected of causing human disease also requires a permit.

Importation permits are issued by the U.S. Public Health Service (USPHS) only to the importer, who must be located in the United States. The importation permit, with the proper packaging and labeling, will expedite clearance of the package of infectious materials through the USPHS Division of Quarantine and Release by U.S. Customs.

Instead of an importation permit, a Letter of Authorization may be issued by the Centers for Disease Control and Prevention (CDC) after review of an "Application to Import an Etiological Agent". The letter is issued for materials that are judged to be noninfectious, but which might be construed to be infectious by U.S. Customs inspection personnel. Letters of Authorization may be issued for items such as formalin fixed tissues, sterile cell cultures, clinical materials such as human blood, serum, plasma, urine, cerebrospinal fluid, and other tissues or materials of human origin when there is no evidence or indication that such materials contain an infectious agent. Letters of Authorization are in effect for two years, and do not require a shipping label to be issued by CDC.

Importation permits and Letters of Authorization are issued by the CDC, Import Permit Program, 1600 Clifton Road NE, Mailstop E-79, Atlanta, Ga. 30333 after review of a completed application form. Application forms may be obtained by calling CDC at (404)498-2260. CDC can also be contacted on the Internet at http://www.cdc.gov/od/ohs/biosfty/imprtper.htm. Completed forms may be returned to CDC by mail or FAX at 404-498-2275. Application to CDC for the importation permit should be made 10 working days in advance of the shipment date to allow time for processing, issuance and delivery of the permit and shipping labels to the permittee.

Facilities transferring or receiving select biological agents must be registered with the CDC or USDA and comply with elaborate regulatory requirements. See Section IIC of the Manual.

Other Permits

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Service (VS) regulates the importation of animals and animal-derived materials to ensure that exotic animal and poultry diseases are not introduced into the United States.

Generally, a USDA veterinary permit is needed for materials derived from animals or exposed to animal-source materials. Materials which require a permit include, animal tissues, blood, cells or cell lines of livestock or poultry origin, RNA/DNA extracts, hormones, enzymes, monoclonal antibodies for IN VIVO use in non-human species, certain polyclonal antibodies, antisera, bulk shipments of test kit reagents, and microorganisms including bacteria, viruses, protozoa, and fungi. Exceptions to this requirement are human and non-human primate tirrues, serum, and blood. They also have information on animal products that do not require an import permit.

Various other animal materials which require a permit include dairy products (except butter and cheese), and meat products (e.g., meat pies, prepared foods) from countries with livestock diseases exotic to the U.S.

Import permit applications may be obtained from the NCIE home page or by writing the Import/Export Animal Products Program at:

USDA, APHIS, VS, NCIE

Products Program

4700 River Road, Unit 40

Riverdale, MD 20737-1231

For further information or questions concerning import applications, please contact the Animal Products Program at Area Code (301)734-3277 or by facsimile at (301)734-8226

The importation or domestic transfer of plant and plant pests are also regulated by the USDA. Information may be obtained by calling 1(877)770-5990 or on the website at http://www.aphis.usda.gov/ppq/permits/index.html.

Export of infectious materials may require license from the Department of Commerce (DoC). Exporters of a wide variety of etiological agents of human, plant, and animal diseases, including genetic material, and products which might be used for culture of large amounts of agents will require an export license.

Information may be obtained by calling the DoC Bureau of Industry and Security, Outreach and Educational Services Division at (202)482-4811.

 

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