Revised_Attachment_8_-_BioSecurity_ _BioSafety_-_SEPRL.pdf

GENERAL LABORATORY

BIOSAFETY / BIOSECURITY

GUIDELINES

Southeast Poultry Research Laboratory 934 College Station Road

Athens, GA 30605

February 1, 2012

SEPRL Biosafety / Biosecurity Guidelines ii

Table of Contents

Facility SHEM Policy Statement -------------------------------------------------------------------------------- 1

Introduction -------------------------------------------------------------------------------------------------- 3

Safety Related Policies --------------------------------------------------------------------------------------------- 5 Head Phones ------------------------------------------------------------------------------------------------------------------ 5 Non-Work Related Visitors ------------------------------------------------------------------------------------------------ 5 Smoking ---------------------------------------------------------------------------------------------------------------------- 5

Security Related Policies ------------------------------------------------------------------------------------------ 5 Personnel Clearance --------------------------------------------------------------------------------------------------------- 5

Permanent Employees --------------------------------------------------------------------------------------------------- 5 Non-Employees – Citizens, Visiting Scientists & Short Term Technicians -------------------------------------- 5 Non-Citizens -------------------------------------------------------------------------------------------------------------- 5

Cameras ----------------------------------------------------------------------------------------------------------------------- 5

Principles of Biosafety & Biosecurity -------------------------------------------------------------------- 7 Definitions -------------------------------------------------------------------------------------------------------------------- 7

Biosecurity - -------------------------------------------------------------------------------------------------------------- 7 Biohazards - -------------------------------------------------------------------------------------------------------------- 7

Laboratory Practice & Technique ----------------------------------------------------------------------------------------- 7 Safety Equipment [Primary Barriers] ------------------------------------------------------------------------------------- 7 Facility Design [Secondary Barriers] ------------------------------------------------------------------------------------- 8

No Contact with Avian Species Policy -------------------------------------------------------------------------- 9

MEMO – No Off-Site Avian Contact -------------------------------------------------------------------------- 11

Exceptions to SEPRL’s No Avian Contact Policy ---------------------------------------------------------- 13

Facility Operating Levels --------------------------------------------------------------------------------- 15

Clean Areas --------------------------------------------------------------------------------------------------------- 15

Production Areas -------------------------------------------------------------------------------------------------- 15

Biosafety Level 1 Areas ------------------------------------------------------------------------------------------- 15

Biosafety Level 2 Areas ------------------------------------------------------------------------------------------- 15

Biosafety Level 3E Areas ----------------------------------------------------------------------------------------- 15

Clothing Requirements & Movement of Personnel --------------------------------------------------- 17

General Information ---------------------------------------------------------------------------------------------- 17 Visitors - All ---------------------------------------------------------------------------------------------------------------- 17 Visitors – Individuals Touring Specific Areas -------------------------------------------------------------------------- 17 Tours ------------------------------------------------------------------------------------------------------------------------- 17 Service persons ------------------------------------------------------------------------------------------------------------- 18 Visiting Scientists, Collaborators & Visiting Technicians ------------------------------------------------------------ 18

General Clothing Requirements -------------------------------------------------------------------------------- 18 Laundering Lab-supplied Clothing --------------------------------------------------------------------------------------- 18 Clean Clothing -------------------------------------------------------------------------------------------------------------- 19 Laboratory Coats ----------------------------------------------------------------------------------------------------------- 19 Coveralls/Scrubs ------------------------------------------------------------------------------------------------------------ 19 Safety Glasses --------------------------------------------------------------------------------------------------------------- 20 Shoes ------------------------------------------------------------------------------------------------------------------------- 20 Undergarments/Socks ------------------------------------------------------------------------------------------------------ 20

February 1, 2012 iii

Specific Clothing Requirements -------------------------------------------------------------------------------- 20 Clean Areas ----------------------------------------------------------------------------------------------------------------- 20

Main Building – Admin & Post-doc Offices ------------------------------------------------------------------------ 20 Building 9 - Meeting Room, Break Room & Post-docs’ Office -------------------------------------------------- 21 Building 9 - Bioengineering Lab & Facility IT’s Office ---------------------------------------------------------- 21

Employees ------------------------------------------------------------------------------------------------------------ 21 Visitors --------------------------------------------------------------------------------------------------------------- 21

Building 10 - Operation & Maintenance Services ------------------------------------------------------------------ 21 Employees ------------------------------------------------------------------------------------------------------------ 21 Visitors --------------------------------------------------------------------------------------------------------------- 21

Building 12 – Storage -------------------------------------------------------------------------------------------------- 21 Building 14 – Machine Shop ------------------------------------------------------------------------------------------ 21

Employees ------------------------------------------------------------------------------------------------------------ 21 Visitors --------------------------------------------------------------------------------------------------------------- 22

Buildings 19 & 21-25 - Storage --------------------------------------------------------------------------------------- 22 Production Area ------------------------------------------------------------------------------------------------------------ 22

Building 11 -------------------------------------------------------------------------------------------------------------- 22 Employees ------------------------------------------------------------------------------------------------------------ 22 Visitors --------------------------------------------------------------------------------------------------------------- 22 Engineering and O & M Personnel ------------------------------------------------------------------------------- 22 Service persons ------------------------------------------------------------------------------------------------------ 23

Buildings 13, 15, 16, 17, 21, 30-31 & 32-33 ------------------------------------------------------------------------ 23 Employees ------------------------------------------------------------------------------------------------------------ 23 Visitors --------------------------------------------------------------------------------------------------------------- 23 Engineering and O & M Personnel ------------------------------------------------------------------------------- 23

Biosafety Level 1 Areas --------------------------------------------------------------------------------------------------- 24 Building 37 – Decontamination Tank Building --------------------------------------------------------------------- 24

Employees ------------------------------------------------------------------------------------------------------------ 24 Visitors --------------------------------------------------------------------------------------------------------------- 24 Engineering and O& M Personnel -------------------------------------------------------------------------------- 24 Service persons ------------------------------------------------------------------------------------------------------ 24

Building 29 - Sequencing Lab ---------------------------------------------------------------------------------------- 24 Employees ------------------------------------------------------------------------------------------------------------ 24 Visitors --------------------------------------------------------------------------------------------------------------- 24 Engineering and O & M Personnel ------------------------------------------------------------------------------- 25 Service persons ------------------------------------------------------------------------------------------------------ 25

Biosafety Level 2 Areas --------------------------------------------------------------------------------------------------- 25 Buildings 3, 7 & 38 - Laboratories ----------------------------------------------------------------------------------- 25

Employees ------------------------------------------------------------------------------------------------------------ 25 Visitors --------------------------------------------------------------------------------------------------------------- 25 Engineering and O & M Personnel ------------------------------------------------------------------------------- 26 Service persons ------------------------------------------------------------------------------------------------------ 26

Buildings 2, 5, 6, 8 & 39 - Animal Housing ------------------------------------------------------------------------ 26 Employees ------------------------------------------------------------------------------------------------------------ 26 Visitors --------------------------------------------------------------------------------------------------------------- 27 Engineering and O & M Personnel ------------------------------------------------------------------------------- 27 Service persons ------------------------------------------------------------------------------------------------------ 27

Biosafety Level 3E --------------------------------------------------------------------------------------------------------- 28 Building 1, 4 and 34 ---------------------------------------------------------------------------------------------------- 28

Employees ------------------------------------------------------------------------------------------------------------ 28 Visitors --------------------------------------------------------------------------------------------------------------- 28 Engineering and O & M Personnel ------------------------------------------------------------------------------- 28 Service persons ------------------------------------------------------------------------------------------------------ 29

Laboratory Equipment ------------------------------------------------------------------------------------ 31

Autoclaves ----------------------------------------------------------------------------------------------------------- 31 iv

Introduction ----------------------------------------------------------------------------------------------------------------- 31 Safety Precautions ---------------------------------------------------------------------------------------------------------- 31 Service ----------------------------------------------------------------------------------------------------------------------- 32 Decontamination Testing & Quality Assurance ------------------------------------------------------------------------ 32

Work Practices for Biosafety Cabinets ------------------------------------------------------------------------ 32 General ----------------------------------------------------------------------------------------------------------------------- 32 Power Failure of BSCs ----------------------------------------------------------------------------------------------------- 33

Movement of Materials ------------------------------------------------------------------------------------ 35

Books, papers & catalogs ---------------------------------------------------------------------------------------- 35

Lab-supplied Clothing - Laundry ------------------------------------------------------------------------------ 35

Glassware & Equipment ----------------------------------------------------------------------------------------- 35

Biological Agents -------------------------------------------------------------------------------------------------- 36

Trash ----------------------------------------------------------------------------------------------------------------- 36

Vehicles -------------------------------------------------------------------------------------------------------------- 36

Working with Biological Agents ------------------------------------------------------------------------- 37

Introduction -------------------------------------------------------------------------------------------------------- 37

Biosafety Level-1 --------------------------------------------------------------------------------------------------- 37 Safety Procedures ----------------------------------------------------------------------------------------------------------- 37 Personal Protective Equipment ------------------------------------------------------------------------------------------- 38 Laboratory Facilities ------------------------------------------------------------------------------------------------------- 38

Biosafety Level-2 --------------------------------------------------------------------------------------------------- 38 Safety Procedures ----------------------------------------------------------------------------------------------------------- 38 Personal Protective Equipment ------------------------------------------------------------------------------------------- 39 Laboratory Facilities ------------------------------------------------------------------------------------------------------- 39

Biosafety Level 3E ------------------------------------------------------------------------------------------------- 40 Safety Procedures ----------------------------------------------------------------------------------------------------------- 40 Personal Protective Equipment ------------------------------------------------------------------------------------------- 40 Laboratory Facilities ------------------------------------------------------------------------------------------------------- 40

Working with Animals ------------------------------------------------------------------------------------- 41

Introduction -------------------------------------------------------------------------------------------------------- 41

Animal Biosafety --------------------------------------------------------------------------------------------------- 41 Safety Procedures ----------------------------------------------------------------------------------------------------------- 41 Personal Protective Equipment ------------------------------------------------------------------------------------------- 42

Entering an Animal Production Building -------------------------------------------------------------------- 43 Building 13, 15, 16 & 17 -------------------------------------------------------------------------------------------------- 43

Showering into a Production Building ------------------------------------------------------------------------------- 43 Exiting a Production Building ----------------------------------------------------------------------------------------- 43

Exiting a BSL2E Animal Room: ------------------------------------------------------------------------------- 43 Building 2, 5, 6, 8 & 39 – BSL2 ------------------------------------------------------------------------------------------ 43

Showering Out of a Building ------------------------------------------------------------------------------------------ 43

Emergency Exit ---------------------------------------------------------------------------------------------------- 44

Animal Facilities --------------------------------------------------------------------------------------------------- 44

Use of Controlled Drugs in Animal Experiments ----------------------------------------------------------- 44 Anesthesia ------------------------------------------------------------------------------------------------------------------- 44

February 1, 2012 v

Euthanasia ------------------------------------------------------------------------------------------------------------------- 45

General Cleanup Protocols ------------------------------------------------------------------------------- 47

Spills - Bio-hazard Materials ------------------------------------------------------------------------------------ 47 Introduction ----------------------------------------------------------------------------------------------------------------- 47 Chemicals Used for Biohazard Decontamination ---------------------------------------------------------------------- 47

SEPRL Approved Chemicals for Biohazard Decontamination --------------------------------------------------- 47 General Considerations ---------------------------------------------------------------------------------------------------- 47 General Procedure ---------------------------------------------------------------------------------------------------------- 48 Procedures for Specific Locations --------------------------------------------------------------------------------------- 48

Bench Top or Lab Floor ----------------------------------------------------------------------------------------------- 48 Biological Safety Cabinet ---------------------------------------------------------------------------------------------- 49 Water Baths and Shaker Baths ---------------------------------------------------------------------------------------- 49 Incubators or Refrigerators -------------------------------------------------------------------------------------------- 49 Centrifuges -------------------------------------------------------------------------------------------------------------- 50

Spills - Outside the Laboratory Area ------------------------------------------------------------------------------------ 50

HEPA Filters – Use, Removal & Disposal -------------------------------------------------------------------- 50 Fumigation ------------------------------------------------------------------------------------------------------------------ 50 Decontamination and Disposal Procedure ------------------------------------------------------------------------------ 51 Additional information on handling specific HEPA filters: ---------------------------------------------------------- 51

Special Operational Procedures ------------------------------------------------------------------------- 52

Transfer of Production Eggs to BYD -------------------------------------------------------------------------- 52

Handling of Eggs & Birds that are from a Non-SEPRL Source ----------------------------------------- 52

Transfer of Birds between Buildings within the Compound --------------------------------------------- 54 General Guidelines --------------------------------------------------------------------------------------------------------- 54 Transfer Protocol ----------------------------------------------------------------------------------------------------------- 54

Operations at BSL3E -------------------------------------------------------------------------------------- 56

Protocols for Removal of Materials --------------------------------------------------------------------------- 56 Removal of Lymphocytes from a BSL3E Facility for Flow Cytometry Testing ----------------------------------- 56 Removal of Pathogenic Agents from a Biosafety Level 3E Laboratory -------------------------------------------- 56

Live Pathogens ---------------------------------------------------------------------------------------------------------- 56 Shipment to another BSL3E+ facility ---------------------------------------------------------------------------- 56

Inactivated Pathogens -------------------------------------------------------------------------------------------------- 57 Tissues inactivated by 10% Buffered Formalin) ---------------------------------------------------------------- 57

Inactivated Amniotic Allantoic Fluid (AAF)------------------------------------------------------------------------ 57 RNA [extracted from AAF] ------------------------------------------------------------------------------------------- 58

Packaging of Biological Materials for Shipment ----------------------------------------------------- 60

Shipping & Receiving of Biological Materials --------------------------------------------------------------- 60 Shipping Biological Materials -------------------------------------------------------------------------------------------- 60

General Requirements -------------------------------------------------------------------------------------------------- 60 What’s Covered --------------------------------------------------------------------------------------------------------- 61 What’s Exempt ---------------------------------------------------------------------------------------------------------- 61 Shipping Forms Required---------------------------------------------------------------------------------------------- 61

Receiving Biological Materials --------------------------------------------------------------------------------- 61 General Requirements ----------------------------------------------------------------------------------------------------- 61 What’s Covered ------------------------------------------------------------------------------------------------------------ 61 What’s Exempt ------------------------------------------------------------------------------------------------------------- 62 Shipping Forms Required ------------------------------------------------------------------------------------------------- 62

Form List ------------------------------------------------------------------------------------------------------------ 62 vi

APHIS VS 16-6A Form ------------------------------------------------------------------------------------------------ 62 APHIS Form 2 ----------------------------------------------------------------------------------------------------------- 62 FedEx M-1421 – Shipper’s Declaration for Dangerous Goods --------------------------------------------------- 62 SEPRL SF-01 ------------------------------------------------------------------------------------------------------------ 62 SEPRL SF-02 ------------------------------------------------------------------------------------------------------------ 63 SEPRL SF-03 - Disclaimer -------------------------------------------------------------------------------------------- 63

Biological Agents Stored in a BSL3E Building -------------------------------------------------------------- 63 Shipment to another BSL3E facility ------------------------------------------------------------------------------------- 63 Receipt of Shipment from another BSL3E facility --------------------------------------------------------------------- 64

Inventory & Control of Biological Materials ---------------------------------------------------------- 66 Definitions: ------------------------------------------------------------------------------------------------------------------ 66 General Information -------------------------------------------------------------------------------------------------------- 66 Infectious Materials Classification --------------------------------------------------------------------------------------- 67

High Consequence Pathogens ----------------------------------------------------------------------------------------- 67 Low Consequence Pathogens ----------------------------------------------------------------------------------------- 67

Repository material -------------------------------------------------------------------------------------------------- 67 Working stocks ------------------------------------------------------------------------------------------------------ 68 Experimental samples ----------------------------------------------------------------------------------------------- 68

Appendix ----------------------------------------------------------------------------------------------------- 70

Form SF-01 - Shipping of Biological Materials ------------------------------------------------------------- 70

Form SF-02 - Receipt of Biological Materials --------------------------------------------------------------- 72

Standard Operational Procedures [SOP] --------------------------------------------------------------- 74 Building 34 ------------------------------------------------------------------------------------------------------------------ 74

SOP-34-1 - Cleaning Animal Rooms with Horsefall units in Building 34 ---------------------------------- 74 SOP-34-2 - Cleaning of animal rooms containing CIS units in Building 34 ------------------------------- 77 SOP-34-3 - Cleaning of animal rooms containing PMI Wash down units in Building 34 --------------- 80 SOP-34-4 - Cleaning of animal rooms containing PMI units in Building 34 ------------------------------ 84 SOP-34-5 - House-keeping Responsibilities in Building 34 ---------------------------------------------------- 88 SOP-34-6 - Building Annual Self-inspection – Building 34 ---------------------------------------------------- 90 SOP-34-7 - Fumigation of Building 34 ---------------------------------------------------------------------------- 92 SOP-34-8 - Transfer of Materials from BSL3E to BSL-2 ----------------------------------------------------- 94 SOP-34-9 - Fumigation of Materials in Building 34 Air-lock ------------------------------------------------- 96 SOP-34-10 - Donning & Doffing a PAPR ------------------------------------------------------------------------- 98 SOP-34-11 - Annual PAPR Inspection -------------------------------------------------------------------------- 100 SOP-34-12 - Annual Self Inspection – Building 34 ------------------------------------------------------------ 102 SOP-34-13 - Standard Operating Procedures for ABSL-3E - Building 34 ------------------------------- 104

Building 1 & 4 ---------------------------------------------------------------------------------------------------- 106 SOP -01 - Preparation for the Fumigation of Building 1 and 4 -------------------------------------------- 106 SOP -02 - Fumigation of Materials Out of Buildings 1&4 using the Fumigation Box ----------------- 108 SOP-03 - Annual Self Inspection - Buildings 1 & 4 ----------------------------------------------------------- 110

Laboratory Equipment ------------------------------------------------------------------------------------------------ 112 SOP-LAB -01 - Autoclave Decontamination and Certification Procedures ----------------------------- 112 SOP-LAB -02 - Annual PAPR Inspection / Filter & Hose Replacement Instructions ----------------- 116 SOP-LAB -03 - Routine PAPR Inspection ---------------------------------------------------------------------- 118

Animal Care Check Sheet --------------------------------------------------------------------------------------------- 120

Annual Review Verification

February 1, 2012 vii

Date Signature

March 16, 2005 John W. Latimer \s\

May 4, 2006 John W. Latimer \s\

August 31, 2007 John W. Latimer \s\

March 9, 2009 John W. Latimer \s\

April 26, 2010 John W. Latimer \s\

February 7, 2011 John W. Latimer \s\

February 1, 2012

February 1, 2012 1

General Lab - Biosafety / Biosecurity Guidelines

Southeast Poultry Research Laboratory

Dated February 27, 2009

Facility SHEM Policy Statement

It is the policy of the U. S. Department of Agriculture, Agricultural Research Service, to safe-guard its employees and property by implementing and maintaining a comprehensive, effective safety, health, and environmental management (SHEM) program in compliance with the laws and Executive Orders. The ARS SHEM program is outlined in ARS Manual 230.0 that is accessible to employees on the ARS Administrative and Financial Management website at http://www.afm.ars.usda.gov/ppweb/PDF/230-0m.pdf . The Agency’s policy is to eliminate or minimize losses incurred by the Agency, individual employees and the general public as a result of actions or incidents involving or producing injury, illness property/environmental damage in the ARS workplace by:

Implementing the Agency’s program for safety, health and environmental management.

Complying with the spirit and letter of safety, health, and environmental legislation and related standards, orders, rules and regulations.

Establishing procedures for procurement, repair, storage, waste management, disposal and salvage operations to prevent accident related losses.

Providing supervisory/employee educational/training opportunities for communicating program function components.

Properly assigning, directing and training ARS employees.

Developing supervisory safety, health and environmental related knowledge and skills.

Developing facility self-protection plans for emergency situations.

Developing and implementing program promotional activities.

Analyzing work assignments to identify potentially hazardous conditions or adverse envi-ronmental consequences.

Developing standard operating procedures that minimize or eliminate potentially hazard-ous conditions or adverse environmental effects.

Analyzing the relationship of the employee, machine and environment for the identifica-tion of potentially hazardous conditions or adverse environmental effects.

Protecting employees from hazardous conditions through isolation, guarding and shielding principles or personal protective equipment.

Developing policies and procedures that minimize or eliminate potentially hazardous con-ditions or adverse personal effect through chemical labeling, hygiene, proper storage and disposal and by inventorying chemical and hazardous substances and materials.

Developing procedures for reviewing, inspecting, auditing and complying with the SHEM program.

The Laboratory Director has the responsibility for developing maintaining, and actively support-ing a strong SHEM program within the Southeastern Poultry Research Laboratory. The LD will provide administrative and managerial backing of committee recommendations and requests (e.g., training opportunities, requests for funding on installation of appropriate engineering controls, or equipment necessary for the elimination of hazardous conditions). As part of this responsibility, a Safety, Health, and Environmental Management Committee (SHEM) has been assigned to man-age and implement the location safety, health, and environmental management program, chaired by an assigned BioSafety/BioSecurity Officer as mandated by Manual 230, Chapter 17.

February 1, 2012 3

Introduction

The following biosafety & biosecurity procedures have been established at Southeast Poultry Re-search Laboratory [SEPRL] in an effort to prevent problems associated with the handling of bio-hazards. These guidelines supersede all existing SEPRL protocols for biosafety & biosecurity;

they will serve as the minimum standards of operation for all biosafety & biosecurity at SEPRL.

These guidelines have been agreed upon by the Biosecurity Advisory sub-Committee [under the IBC] as the appropriate procedures of operation for SEPRL at this time; however, this document will be reviewed periodically; changes and updates will be made as needed.

Personnel are encouraged to discuss any questions they may have with their immediate supervi-sor, the Chair of the Biosecurity Advisory sub-Committee, the Facility Manager, Research Lead-ers &/or the Laboratory Director.

The biosafety & biosecurity procedures at SEPRL are intended to accomplish the following:

Prevent the transfer of infectious agents to avian populations located off the SEPRL premises. Employees are required to avoid away from work contact [except for work re-lated reasons] with commercial poultry or other domestic or exotic avian species. This is a critical “barrier”, because an agent release from our laboratory could produce a major economic loss in the poultry industry. This is also the reason there is so much concern when an item such as equipment leaves the premises; it must be adequately decontaminat-ed before leaving. In the case of a viable material being shipped, the agent must be suffi-ciently contained & the receiving laboratory must have adequate containment facilities.

Prevent infection of personnel. The importance of prevention of employee illness is ob-vious & is accomplished by effective use of primary barriers, such as safety cabinets;

good lab technique, such as no mouth pipetting; & good personal hygiene, i.e. hand washing. An important point to consider is that if an employee becomes infected, a clothes change & shower will no longer provide the barrier for preventing an infectious agent being carried away from SEPRL.

Prevent transmission of disease to SEPRL production flocks. Our specific-pathogen-free [SPF] flocks are the source of susceptible chickens, turkeys & embryonated eggs for most of the research at SEPRL. Infection of these flocks with any of the common poultry pathogens could make the eggs & progeny unsuitable for ongoing & future studies.

Prevent cross-contamination of laboratory & animal experiments. This is necessary for the production of valid & reproducible research.

SEPRL Biosafety - Biosecurity Guidelines

Intentionally left blank

February 1, 2012 5

Safety Related Policies

Head Phones

While on the premise, neither lab personnel or visitors are allowed to wear headphones that cover both ears. This rule applies to cell phones or any other audio device.

Headphones can be worn while at one’s desk & listening to work related training material or software.

Non-Work Related Visitors

Such personnel must be escorted at all times.

Smoking

Smoking is not permitted inside any building on the premise.

Smoking is only permitted at the designated areas, outside building 9, near the concession room door & near the East end of building 10.

Security Related Policies

Personnel Clearance

Permanent Employees

All permanent employees working at SEPRL must have at least a PSL-1 clearance. A PSL-2 clearance is required for working in the high-containment buildings. Additional requirements must be met for working with Select Agents.

Non-Employees – Citizens, Visiting Scientists & Short Term Technicians

Such personnel must be escorted at all times.

Non-Citizens

To work, such personnel must submit an ARS-230 form & be cleared; they must also be escorted at all times, unless other clearances are obtained.

Cameras

Neither visitors nor employees are allowed to photograph the exterior of the facility build-ings without permission of the Lab Director or designee.

February 1, 2012 7

Principles of Biosafety & Biosecurity

Definitions

Biosafety - Protection of personnel from infection by an agent.

Biosecurity - Containment of an infectious agent, so as to prevent an unplanned expo-sure, infection or transmission to susceptible bird populations.

Biohazards - Infectious agents or parts thereof, that present a real or potential risk to the well being of man or other animals; this includes agents used in conventional microbiological experimentation as well as in the applica-tion of approaches broadly defined as recombinant DNA methods.

The term biosafety/biosecurity is used in describing safe methods for managing agents in the la-boratory & animal housing environment. The purpose is to reduce or eliminate exposure of per-sonnel & the environment to potentially hazardous agents through containment of the agent be-ing used.

Three basic elements of containment are: 1) good laboratory practice & technique; 2) safety equipment; 3) facility design. A risk assessment of the work to be done with a specific agent will determine the appropriate combination of these elements needed.

A key to the success of the biosafety/biosecurity program is the establishment & maintenance of multiple barriers. One of the more important barriers is a change by personnel into lab-supplied clothes & shoes before working with infectious materials &/or infected animals. When lab clothing is used, the individuals personal clothing does not become contaminated & serve as a fomite for carrying infectious materials away from the laboratory.

Additional precautions [barriers] are added when the risk is greater, as in high containment labs & animal facilities, where a shower must be taken before leaving the building in order to prevent carrying an infective agent out of the building. Similarly, employees working in SEPRL’s clean-bird Production Area must shower just before they enter each flock’s room, where the concern is to avoid bringing an infective agent into our clean Production flocks.

Laboratory Practice & Technique

The most important element of containment is strict adherence to standard microbiological prac-tices & techniques. Persons working with infectious agents or potentially infected materials must be aware of the potential hazards & be trained & proficient in the practices & techniques required to safely handle such material.

The immediate supervisor is responsible for providing or arranging for appropriate training of supervised personnel.

Safety Equipment [Primary Barriers]

Good microbiological technique & the use of appropriate safety equipment provide protection of both the personnel & the immediate laboratory environment from exposure to infectious agents.

Safety equipment includes biological safety cabinets & other engineering controls designed to remove or minimize exposure of workers to hazardous biological materials & at the same time contain the agent. A biological safety cabinet is a very effective means for providing contain-ment of splashes or aerosols generated during microbiological procedures & for protecting the worker during those procedures. Another example is the safety centrifuge cup, which is an en-closed container designed to prevent aerosols from being released during centrifugation.

Safety equipment also includes items for personal protection such as gloves, coats, gowns, shoe covers, boots, respirators, face shields, safety glasses & goggles. Personal protective equipment is often used in combination with biological safety cabinets or other devices in order to contain the agent or material.

In some situations it is impractical to work in a biological safety cabinet. Personal protective equipment then becomes the primary protective barrier between personnel & the infectious mate-rial. Examples include certain animal studies, necropsy, agent production activities & activities relating to maintenance or service support of the facility.

Facility Design [Secondary Barriers]

Secondary containment - the protection of the environment outside the laboratory - is provided by a combination of facility design & operational practices.

The design of the facility is important in providing a barrier to protect persons working inside & outside the lab work-area & to protect persons & animals in the community from infectious agent releases. Laboratory management is responsible for providing facilities commensurate with the laboratory’s function & the recommended biosafety level for the agents being manipu-lated.

The recommended secondary barrier[s] will depend on the risk of transmission of specific agents. Minimally, these secondary barriers include separation of the laboratory work-area from public access, availability of decontamination equipment [e.g., autoclave], & hand washing facil-ities. As the risk for aerosol transmission increases, higher levels of primary containment & multiple secondary barriers may become necessary to prevent infectious agents from escaping into the environment. Design features could include specialized ventilation systems to assure di-rectional airflow, air treatment systems to decontaminate or remove agents from exhaust air, con-trolled access zones within buildings or fencing to separate buildings and containment zones, air-locks at laboratory entrances, or separate buildings or modules for isolation of the agent.

February 1, 2012 9

No Contact with Avian Species Policy

A crucial link in SEPRL’s effort to maintain a high level of biosecurity is dependent on its per-sonnel & those service persons and visitors who have contact with SEPRL. The degree to which this effort will work depends on your understanding of the need & your commitment to SEPRL’s mission.

It is very important that employees, SEPRL’s Operation & Maintenance employees & visiting laboratory personnel, comply with the policy of having no contact with any avian species or their housing when away from SEPRL. This requirement is our first defensive effort [& an im-portant one] in preventing infection of our flocks as well as guarding against the escape of an in-fectious agent.

As a current employee, you have read & signed the SEPRL No Off-Site Contact with Avian Species memo.

Supervisors should inform prospective employees of these avian no-contact restrictions during the interview process and be sure that they read this memo and agree to comply if employed.

New employees are required to sign a copy of this memo as they begin working at SEPRL.

Visiting laboratory personnel are also required to sign this memo & not to not have any avian contact for a period of one week before & after completing their visit.

A copy of the memo can be found on the following page.

February 1, 2012 11

MEMO – No Off-Site Avian Contact

DATE: March 9, 2008 SUBJECT: No Off-site Contact with Avian Species

TO: SEPRL Employees & Visiting Laboratory Workers FROM: David E. Swayne, Laboratory Director

Southeast Poultry Research Laboratory [SEPRL] is a unique research facility that includes a production unit for rearing specific-pathogen-free [SPF] chickens and turkeys; and containment facilities for research on exotic, endemic and emerging avian disease problems that impact avian and human health.

Disease transmission among poultry flocks is often associated with personnel or equipment movement from infected to susceptible flocks. To prevent the spread of infectious diseases at SEPRL, we rely on a series of operational [clothes changes, showers, etc.] and physical barriers. These barriers, described in detail in SEPRL’s General Laboratory Biosafety/Biosecurity Guidelines, are intended to prevent the re-lease of infectious agents from our laboratory and animal buildings. We require these precautions for two reasons: 1] chickens, turkeys, and pet birds are susceptible to one or more of the infectious agents in our research program; 2] infections of commercial poultry & pet birds are a potential hazard to our produc-tion flocks. Consequently, we are not only concerned about what personnel might accidentally carry away, but we are also concerned about what personnel can bring to SEPRL! Such events could result in the infection of our SPF flocks or flocks outside our premises at a great economic loss. Either event would have a disastrous impact on our perceived capability & could affect our ability to continue our re-search program.

As a final barrier is the stipulation that employees are not to come into contact with susceptible avian species or their housing when away from SEPRL, without written permission from the Lab Director [or his representative]. This prohibition includes no visit to or working on a poultry farm or other location where poultry are present; and no poultry or pet bird(s) in your residence or on the property where you re-side. The Lab Director can give an exemption to limited avian contact, as long as the employees & visi-tors must not have any contact with susceptible animal species for a period of at least five [5] days after being in a BSL2 lab or animal building used for endemic disease research & seven [7] days after being in a BSL3E lab or animal building used for exotic & emerging disease research.

These restrictions may be more restrictive than at laboratories where you might have worked in the past.

But, such requirements are not unique to this laboratory. Employees & visitors to the USDA Plum Island Animal Disease Center off Long Island, NY agree to identical rules. And, the USDA Animal & Plant Health Inspection Service has a similar rule that prohibit its employees from coming into contact with susceptible species for at least seven days after being in contact with or on a premise where infected spe-cies are located.

Hopefully, everyone will understand the reason for these restrictions & will comply with not only the let-ter but also the spirit of the rule; thereby realizing the serious negative effects that could result from the inadvertent release of a pathogen from our laboratory.

Please sign, date & return this memo to the BioSecurity Officer, so that we will have a record that you have received, read & understand these requirements.

Signature: Date:

Printed Name:

Intentionally Left Blank

February 1, 2012 13

Exceptions to SEPRL’s No Avian Contact Policy

The Laboratory Director has agency and unit responsibility for biosecurity and biosafety at SEPRL. He can grant a temporary exception to SEPRL’s No Avian Contact for Employees Pol-icy on a case-by-case basis; however, such exceptions will be only for research purposes related to grantee’s official work, but the time limit will not be reduced below the regulatory require-ment of five [5] days for low pathogenic avian influenza or seven [7] days for SA access.

SEPRL has an absolute, no time-limit, no avian contact rule for off-site for all employees.

Seeking approval for an exception to the No Avian Contact Policy:

The decision to make an exception to the No Avian Contact Policy remains with the Labora-tory Director. Exceptions to the policy are not at the discretion of the employee. Activities that do not require approval from the Laboratory Director are listed at the end of this section.

The Laboratory Director may consult with the Biosecurity Advisory Committee.

Approval for avian contact off-site is temporary and for a specified period of time.

If you intend to go to a location where you might encounter contact with avian species, ask the Laboratory Director or Chair of the Biosecurity Advisory Committee about the need for approval.

Avian contact off-site includes visits to commercial and non-commercial poultry houses and farms; hatcheries, live-poultry markets, distributors, auctions and other activities where the employee might have direct contact with avian species.

Employees that work in SEPRL BSL3E areas should take extra care when entering situations where there may be unexpected bird contact [away from work].

Required conditions for approval of off-site avian contact:

The employee must have sufficient time away from the direct handling of SEPRL infectious agents, infected materials or infected animals and not have been in a containment laboratory or animal room with infectious materials for a reasonable period of time before contact with avian species off-site.

This time period before contact off site will generally be 5 days for BSL-2 agents and 7 days for BSL3 agents.

An employee returning to SEPRL after avian contact off-site should not have direct con-tact with any production facilities at SEPRL, including equipment rooms, for 5-7 days.

During the approved period for avian contact off-site, the employee should not have contact with infectious agents, infected materials or infected animals while at SEPRL and should not enter SEPRL’s containment laboratories or animal rooms.

Clothing, shoes and related laboratory items that will be worn off-site should be new, laun-dered, clean and/or disinfected as appropriate to reduce the risk of transferring any infectious material off-site. Disposable clothing is recommended to be used when possible.

Any equipment that will accompany the employee off-site must be decontaminated before leaving SEPRL.

Returning samples and equipment must be handled as contaminated materials until appropri-ately decontaminated, or used for research purposes in facilities at the appropriate level of biocontainment.

Decontamination methods appropriate for materials coming back to SEPRL should be a component of the plan for off-site avian contact.

Activities that do not require approval from the Laboratory Director:

Visits to public exhibitions, parks or recreation areas that will not involve direct avian con-tact, such as, zoological parks, wildlife refuges, local parks, lakes, etc.

Post-mortem examination of avian species off-site in a teaching, diagnostic or laboratory set-ting, provided all contact is with dead or euthanized birds and that the birds will be disposed of in a proper manner.

February 1, 2012 15

Facility Operating Levels

SEPRL facilities include clean areas, areas used for the housing and production of the SPF flocks, and laboratory and animal areas operating at different biosafety…