Form APHIS/CDC FORM 1 APHIS/CDC FORM 1 Application for Registration for Possession, Use, and Tr

Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)

APHIS-CDC Form 1 Application for Registration_clean version

Application for Registration (APHIS/CDC Form 1)

OMB: 0920-0576

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AShape651 ccording to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number.  The valid OMB control number for this information collection is 0920-0576.  The time required to complete the information collection for CDC ranges from 4 to 31 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.





Application for

Registration for Possession, Use, and Transfer of SELECT AGENTS and Toxins

(APHIS/CDC FORM 1)


FORM APPROVED

OMB NO. 0920-0576

EXP DATE 1/31/2024


0BSection 1A – Entity Information

Type of Entity: Academic (Private) Academic (State) Commercial (Profit)

25B Government (Federal) Government (State/Local) Private (Non-Profit)

26BENTITY INFORMATION

Entity Name:

Physical Address (NOT a post office box):

City:

State:

Zip Code:

Additional Physical Address(es):

Type of Entity: Academic (Private) Academic (State) Commercial (Profit)

 Government (Federal) Government (State/Local) Private (Non-Profit)

RESPONSIBLE OFFICIAL INFORMATION

Last Name:

First Name:

DOJ Number:

Date of
Birth:

Business E-mail Address:

Title (e.g., Biosafety Officer):

Shape2 Tier 1 Access

Business Telephone #:

Emergency Telephone #:

Mailing Address (NOT a post office box):

City:

State:

Zip Code:

ALTERNATE RESPONSIBLE OFFICIAL INFORMATION

Last Name:

First Name:

DOJ Number:

Date of
Birth:

Business E-mail Address:

Title (e.g., Biosafety Officer):

Shape3 Tier 1 Access

Business Telephone #:

Emergency Telephone #:

Mailing Address (NOT a post office box):

City:

State:

Zip Code:

2nd ALTERNATE RESPONSIBLE OFFICIAL INFORMATION

Last Name:

First Name:

DOJ Number:

Date of
Birth:

Business E-mail Address:

Title (e.g., Biosafety Officer):

Shape4 Tier 1 Access

Business Telephone #:

Emergency Telephone #:

Mailing Address (NOT a post office box):

City:

State:

Zip Code:

OWNER / CONTROLLER INFORMATION (If Applicable)

Last Name:

First Name:

DOJ Number:

Date of Birth:

Shape5 Tier 1 Access

2nd OWNER / CONTROLLER INFORMATION (If Applicable)

Last Name:

First Name:

DOJ Number:

Date of Birth:

Shape6 Tier 1 Access


1BSection 1B – Certification of Responsibility


I hereby certify that I have been designated as the Responsible Official or the Alternate Responsible Official(s) for the institution/organization listed above, that I am authorized to bind the institution/organization, and that the information supplied in this registration package is, to the best of my knowledge, accurate and truthful. The institution/organization listed above meets the requirements specified in 42 CFR Part 73 and/or 7 CFR Part 331 and/or 9 CFR Part 121, is equipped and capable of safely and securely handling the agent(s), and will use or transfer these agents solely for purposes authorized by 42 CFR Part 73 and/or 7 CFR Part 331 and/or 9 CFR Part 121.


I understand that submission of a false statement and/or failure to comply with the provisions of the applicable regulations (42 CFR Part 73 and/or 7 CFR Part 331 and/or 9 CFR Part 121) may result in the immediate revocation of this entity's registration, a civil penalty of up to $500,000 for each violation, and a criminal penalty and/or imprisonment up to five years for each violation. (7 USC 8401; 18 USC 175, 175B, 1001, 3559, 3571; 42 USC 262a).







Responsible Official Signature


Date


Responsible Official Name







Alternate Responsible Official Signature


Date


Alternate Responsible Official Name







2nd Alternate Responsible Official Signature


Date


2nd Alternate Responsible Official Name







3rd Alternate Responsible Official Signature


Date


3rd Alternate Responsible Official Name







4th Alternate Responsible Official Signature


Date


4th Alternate Responsible Official Name


5th Alternate Responsible Official Signature


Date


5th Alternate Responsible Official Name














2BSection 1C – Entity Abstract


Provide a summary of the overall institution mission, functions, and size. This information can include a general estimated number of employees, square footage of entire campus or facility, number of laboratories, overall scope of research, and any international collaborations. Specialized areas of research, education, or expertise can be highlighted. Include a brief description of the management structure of the institution related to oversight of the select agent facility/facilities. Provide a brief summary of the select agent and toxin work at the entity including mission, function, and size. Note: information specific to select agents and toxins will be required in later sections of this application.








3BSection 2 – Responsible Official Certification of Personnel and Facility Activities

I certify that the following requirements are in effect and contain all information required by the Select Agent regulations [7 CFR 331, 9 CFR 121, and 42 CFR 73]

Security, Biosafety and Incident Response


There is a written, site-specific security plan designed according to a site-specific risk assessment that provides graded protection in accordance with the risk of the select agent and/or toxin.


There is a written, agent-specific, and site-specific biosafety plan commensurate with the risk of the select agent and/or toxin that contains sufficient information and documentation to describe the biosafety and containment procedures.


There is a written, site-specific incident response plan commensurate with the hazards of the select agent and/or toxin that fully describe the entity’s response procedures to include the theft, loss or release of a select agent and/or toxin, inventory discrepancies, security breaches, natural disasters and emergencies.


The security, biosafety and incident response plans are reviewed annually and revised as necessary, including after any drill or exercise and after any incident.


Laboratory specific drills or exercises are conducted at least annually to validate or test the effectiveness of the security, biosafety and incident response plans.


Training


Individuals with access approval, authorized visitors, and escorted personnel are provided training on safety, security, and incident response for select agents and/or toxins, as appropriate for their role, as defined in and 7 CFR 331.15, 9 CFR 121.15, and 42 CFR 73.15.


Records


Complete records are maintained for at least 3 years that include but are not limited to:


an accurate, current inventory for each select agent and/or toxin possessed,


information about all entries into areas containing select agent and/or toxin, and


a current list of all individuals that have been granted access approval.


Responsible Official Duties & APHIS/CDC Program Notification

The Responsible Official will:


Ensure annual inspections are conducted for each laboratory and storage area where select agent and/or toxin are stored or used to assess compliance with the requirements of the select agent regulations.


Submit an amendment for any change in circumstances to the certificate of registration, including but not limited to: adding or removing individuals, addition of a suite/room prior to use or storage of select agent and/or toxin and any changes to Responsible or Alternate Responsible Official contact information.


Submit an amendment describing work prior to an individual or entity conducting a restricted experiment as defined in 7 CFR Part 331.13, 9 CFR Part 121.13 or 42 CFR Part 73.13.


Ensure inventory audits are conducted as defined in 7 CFR Part 331.11, 9 CFR Part 121.11 or 42 CFR Part 73.11.


4BSection 2 – Responsible Official Certification of Personnel and Facility Activities (Continued)

I certify that the following requirements are in effect and contain all information required by the Select Agent regulations [7 CFR 331, 9 CFR 121, and 42 CFR 73] (initial each line):


Responsible Official Duties & APHIS/CDC Program Notification (Continued)

The Responsible Official will:


Request authorization from the Federal Select Agent Program using APHIS/CDC Form 2 prior to inter-entity transfer of a select agent and/or toxin, as put forth within Section 16 of the Select Agent regulations.



Upon discovery of a theft or loss, immediately notify the Federal Select Agent Program and appropriate Federal, State, or local law enforcement agencies. Immediate notification is also required upon discovery of a release of a select agent or toxin causing occupational exposure or a release of a select agent and/or toxin outside the primary barriers of the containment area. An APHIS/CDC Form 3 must be submitted to the Federal Select Agent Program within seven calendar days upon discovery of a theft, loss, or release.


Immediately report the identification of any APHIS select agent as defined in 9 CFR 121.5, or the identification of any Tier 1 select agent and/or toxin, to the Federal Select Agent Program and other appropriate authorities when required by Federal, State, or local law. Submit APHIS/CDC Form 4 for the identification and final disposition of any select agent or toxin contained in a specimen presented for diagnosis or verification within seven calendar days of identification and/or in a specimen presented for proficiency testing within 90 calendar days of receipt of the sample.












Responsible Official Signature


Date


Responsible Official Name (Typed or Printed)




5BSection 3 – Select Agents and Toxins



HHS Agents and Toxins

(Check if possessed)

Overlap Agents and Toxins

(Check if possessed)

USDA Agents and Toxins

(Check if possessed)


Shape7



Shape8



Shape9



Shape10



Shape11



Shape12



Shape13



Shape14



Shape15



Shape16



Shape17



Shape18



Shape19



Shape20



Shape21



Shape22



Shape23



Shape24



Shape25



Shape26



Shape27



Shape28



Shape29



Shape30



Shape31



Shape32



Shape33



Shape34



Shape35



Shape36



Shape37



Shape38



Shape39



Shape40



Shape41



Shape42



Shape43



Shape44



Shape45



Shape46



Shape47



Shape48



Shape49



Shape50



Shape51





6BSection 4A – Laboratorians and Animal Care Staff

Tier 1 Access

Last Name


First Name



DOJ Unique Identifier Number

Date of Birth

(mm/dd/yyyy)


Role

Supervising Principal Investigator

Shape52







Shape53







Shape54







Shape55







Shape56







Shape57







Shape58







Shape59







Shape60







Shape61







Shape62







Shape63







Shape64







Shape65







Shape66







I certify that information and training on safety, security, and incident response for working with select agents and toxins has been or will be provided to the individuals listed above before they have access to select agents and toxins. Training will address the needs of the individual, the work being performed, and risks posed by the select agents and/or toxins. Annual refresher training will be provided for these individuals. Written records and the means used to verify that the individuals understood the training will be maintained for at least three years.


RO/ARO Signature:_________________________________________________ Date: _______________




7BSection 4B – Support Staff

Tier 1 Access

Last Name


First Name



DOJ Unique Identifier Number

Date of Birth

(mm/dd/yyyy)

Role

Shape67






Shape68






Shape69






Shape70






Shape71






Shape72






Shape73






Shape74






Shape75






Shape76






Shape77






Shape78






Shape79






Shape80






Shape81






I certify that information and training on safety, security, and incident response for select agents and toxins, as appropriate for their role, has been or will be provided to the individuals listed above before they have access to select agents and toxins. Training will address the needs of the individual, the work they do, and risks posed by the select agents and/or toxins. Annual refresher training will be provided for these individuals. Written records and the means used to verify that the individuals understood the training will be maintained for at least three years.


RO/ARO Signature:_________________________________________________ Date: _______________



8BSection 4C – Unescorted Visitors

For guidance and instructions on Visitors, please see www.selectagents.gov

Tier 1 Access

Last Name


First Name



HOME ENTITY DOJ Unique Identifier Number

Date of Birth

(mm/dd/yyyy)


Supervising Principal Investigator


Shape82






Shape83






Shape84






Shape85






Shape86






Shape87






Shape88






Shape89






Shape90






Shape91






Shape92






Shape93






Shape94






Shape95






Shape96






I certify that information and training on safety, security, and incident response for working with select agents and toxins has been or will be provided to the individuals listed above before they have access to select agents and toxins. Training will address the needs of the individual, the work being performed, and risks posed by the select agents and/or toxins. Annual refresher training will be provided for these individuals. Written records and the means used to verify that the individuals understood the training will be maintained for at least three years.


RO/ARO Signature:_________________________________________________ Date: _______________






9BSection 5A – Entity-Wide Security Assessment and Incident Response

1.

The facility is: (check all that apply)






Shape97

Government owned

Shape98

Rented/leased




Shape99

Entity owned

Shape100

Shared with another entity or




Shape101

Other ______________________


program









2.

Does the entity have a security officer or other individual(s) identified to assist the RO in security matters?

Shape102 Yes

Shape103 No




If yes, does the security plan contain procedures for coordination between the RO and the entity’s security professionals?

Shape104 Yes

Shape105 No








3.

A threat assessment has been conducted:

Shape106 Yes

Shape107 No



a.

Were local law enforcement or federal agencies consulted in developing the threat assessment?

Shape108 Yes

Shape109 No



b.

Has there been a break-in at the entity in the last three years?

Shape110 Yes

Shape111 No



c.

Have there been any direct threats against the entity or its scientists in the last three years?

Shape112 Yes

Shape113 No



d.

Have there been protests at the entity in the last three years?

Shape114 Yes

Shape115 No




If yes to any of the above, describe below. Add additional sheets as needed.















4.

Insider risk assessment





a.

As a condition of granting unescorted access, the entity, or another organization on behalf of the entity, verifies (check all that apply):






Shape116

Educational background






Shape117

Previous work references






Shape118

Criminal history (beyond the security risk assessment approved by the Federal Select Agent Program)




Shape119

Other ____________________________






Shape120

None





b.

Does the entity have policies and procedures for self and peer reporting?

Shape121 Yes

Shape122 No



c.

Does the entity have additional requirements for personnel suitability to retain access to select agents or toxins?

Shape123 Yes

Shape124 No









5.

Natural hazards





a.

Is the entity located in any of the following hazard zones?






Shape125

Flood/flood zone

Shape126

Earthquake (as defined by USGS)




Shape127

Hurricane

Shape128

Wildfire




Shape129

Tornado

Shape130

Tsunami




Shape131

Other__________________________





b.

In the event of a natural disaster with warning, the entity will (check all that apply):






Shape132

Secure the select agent and/or toxin in place.






Shape133

Transfer the select agent and/or toxin to an alternate registered location or entity.




Shape134

Destroy the select agent and/or toxin.






Shape135

Other ____________________________









Section 5A – Entity-Wide Security Assessment and Incident Response (Continued)

6.

Are there electronic records and databases that would allow access to select agent and/or toxin?

Shape136 Yes

Shape137 No




If yes, indicate the means to control access by completing a-f below:





a.

Is a stand-alone (non-networked) computer employed?

Shape138 Yes

Shape139 No



b.

Are there area external connections to systems that control security of the facility (remote log in, work from home)?

Shape140 Yes

Shape141 No



c.

Is access to files or equipment containing select agent and/or toxin related information granted to users only when necessary to fulfill their roles and responsibilities?

Shape142 Yes

Shape143 No



d.

Is user access modified when roles and responsibilities change or when their access to select agent and/or toxin is suspended or revoked?

Shape144 Yes

Shape145 No



e.

Are user-based passwords employed?

Shape146 Yes

Shape147 No



f.

Are anti-virus and anti-malware programs employed?

Shape148 Yes

Shape149 No








7.

Shipping/Receiving





a.

Does the entity have a centralized receiving area?

Shape150 Yes

Shape151 No



b.

Are all personnel who ship or receive select agent and/or toxin shipments Security Risk Assessment (SRA) approved?

Shape152 Yes

Shape153 No



c.

Are select agent and/or toxin shipments stored in a registered and secured area prior to distribution to the Principal Investigators (PIs)?

Shape154 Yes

Shape155 No







8.

Does the entity transport select agent and/or toxin outside of registered area(s)?

Shape156 Yes

Shape157 No




If yes, does the security plan address transport of select agent and/or toxin material






a.

through non-registered areas?

Shape158 Yes

Shape159 No




b.

during intra-entity transfers using chain of custody documentation?

Shape160 Yes

Shape161 No







9.

Has a response time for local law, guard force or other designated responders been determined?

Shape162 Yes

Shape163 No







10.

Is permission required to conduct select agent and/or toxin work after established work hours?

Shape164 Yes

Shape165 No




If yes, who grants permission?






Shape166

RO/ARO




Shape167

PI




Shape168

Other _________________________










10BSection 5B – Entity-Wide Biosafety/Biocontainment


1.

Describe the program or expertise used to develop and implement the biosafety and biocontainment procedures described in the site-specific biosafety or biocontainment plan. Add additional sheets as needed.








2.

Laboratory personnel must demonstrate proficiency in laboratory procedures prior to working with select agents and/or toxins.

Shape169 Yes

Shape170 No





3.

Appropriate Personal Protective Equipment (PPE) for the select agent and/or toxin and the work performed is required.

Shape171 Yes

Shape172 No





4.

Individuals with access to Tier 1 select agent and/or toxin are enrolled in an occupational health program.

Shape173 Yes

Shape174 No






5.

Laboratory personnel with access to non Tier 1 select agent and/or toxin are enrolled in an occupational health program as appropriate.

Shape175 Yes

Shape176 No





6.

There are policies for the safe handling of sharps.

Shape177 Yes

Shape178 No





7.

There is a spill protocol in place appropriate to the select agent and/or toxin risk.

Shape179 Yes

Shape180 No





8.

There is an effective, integrated pest management program in place.

Shape181 Yes

Shape182 No



11BSection 5C – Entry Requirements for Federal Select Agent Program Inspectors


1.

Describe procedures for entry to the facility, such as gate location, visitor reception area, and parking for inspectors performing a site visit. Add additional sheets as needed.












2.

Identification requirements:





Shape183

Government ID





Shape184

Other ID (describe) ____________________





3.

Are there security clearance requirements?

Shape185 Yes

Shape186 No



If yes, check all that apply.




Shape187

Exchange of security clearance documentation






Describe ____________________________________________


Shape188

Completion of entity specific security documentation




Describe ____________________________________________





4.

Is respiratory protection required?

Shape189 Yes

Shape190 No


a.

Documentation of medical clearance for respirator use required.

Shape191 Yes

Shape192 No


b.

List required respirators (check all that apply):





Shape193

N95





Shape194

N100





Shape195

PAPR: If required, will the entity provide PAPRs?

Shape196 Yes

Shape197 No



Shape198

Other ___________________







5.

List other PPE required (indicate what will be provided by the entity). Add additional sheets as needed.












6.

Medical documentation required:

Shape199 Yes

Shape200 No


a.

Immunizations

Shape201 Yes

Shape202 No



Shape203

Required (specify) ________________________________________________



Shape204

Recommended (specify) ___________________________________________


b.

PPD skin test (e.g. for animal clearance)

Shape205 Yes

Shape206 No



Shape207

In past 6 months?





Shape208

In the past 12 months?









7.

Is entity specific training required?

Shape209 Yes

Shape210 No



If yes, provide a description (including the estimated time to complete all entry training for inspectors). Add additional sheets as needed.












8.

Describe any additional entry requirements for inspectors. Add additional sheets as needed.









12BSection 6A – Building and Suite/Room Specific Security




1.

Will this suite/room be used for Tier 1 select agent and/or toxin?

Shape211 Yes

Shape212 No









2.

Perimeter security measures outside the building (check all that apply):







Shape213

Security lighting





Shape214

Bars/security film on windows





Shape215

Exterior intrusion detection system





Shape216

Perimeter fence





Shape217

Roving guards





Shape218

Video surveillance of all access points





Shape219

Vehicle screening





Shape220

Other ________________________





Shape221

None









3.

Access to building(s) or other area(s) housing the suite/room is controlled by (check all that apply):





Shape222

Lock and key

Shape223

Card access system





Shape224

Biometric system

Shape225

Card access system w/ PIN





Shape226

Other _____________________________

Shape227

Guards





Shape228

None











4.

Additional security measures present in the interior of the building where select agent and/or toxin is stored or used (check all that apply):




Shape229

Additional locked doors

Shape230

Biometric System






Shape231

Card access system

Shape232

Intrusion detection system






Shape233

Card access system with PIN













5.

Access to suite/room where select agent and/or toxin is stored or used is controlled by (check all that apply):




Shape234

Lock and key

Shape235

Card access system with PIN




Shape236

Card access system

Shape237

Biometric System




Shape238

Other _____________________________________________________________








6.

Access to the storage unit(s) where select agent and/or toxin are housed is controlled by (check all that apply):




Shape239

No access control on the storage unit(s)




Shape240

Lock and key




Shape241

Card access system




Shape242

Card access system with PIN




Shape243

Biometric System




Shape244

Other _____________________________________________________________









7.

Is there a pass through autoclave in the suite/room?

Shape245 Yes

Shape246 No




If yes, are the doors interlocked?

Shape247 Yes

Shape248 No







8.

Is an autoclave outside of the suite/room used for decontamination of select agent and/or toxin waste?

Shape249 Yes

Shape250 No




If yes, distance from suite/room to autoclave ___________________








9.

Is there a pass through window or box at the perimeter of the suite/room?

Shape251 Yes

Shape252 No




If yes, is it secured?

Shape253 Yes

Shape254 No








10.

Is there a dunk tank at the perimeter of the suite/room?

Shape255 Yes

Shape256 No




If yes, is it secured?

Shape257 Yes

Shape258 No






13BSection 6B – Room/Suite Physical Information

For each registered storage area, laboratory suite or room:

Include a floor plan for the suite or room where select agent and/or toxin is to be used or stored. Floor plan for each suite or room should include as applicable: points of entry and/or egress for personnel, locations of equipment [including but not limited to]: sink, eyewash, fume hood, freezer, refrigerator, floor drains, showers, incubator, centrifuge, animal caging, autoclave, Biological Safety Cabinet (BSC) including type (e.g., Class II, Type A2; Class III)], Heating Ventilation and Air Conditioning (HVAC) supply and exhaust vents, and cage washing area. A separate floor plan specifying airflow may also be requested.


For storage only area(s), proceed to Section 7.


Answer the following questions for each laboratory suite or room:


The following questions may not apply to all biosafety levels. The accompanying instructions detail which questions apply to each biosafety level according to the current edition of the Biosafety in Microbiological and Biomedical Laboratories (BMBL), the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules, and the American Society of Tropical Medicine and Hygiene Arthropod Containment Guidelines. If the question does not apply to the laboratory suite or room, check “No”.


1.

This laboratory is operated at (check all that apply):





Shape259

BSL2

Shape260

NIHBL2

Shape261

NIHBL2-LS



Shape262

ACL3



Shape263

BSL3

Shape264

NIHBL3

Shape265

NIHBL3-LS



Shape266

ACL4



Shape267

BSL4

Shape268

NIHBL4

Shape269

NIHBL4-LS







Shape270

ABSL2

Shape271

NIHBL2N









Shape272

ABSL3

Shape273

NIHBL3N









Shape274

ABSL3Ag

Shape275

NIHBL4N









Shape276

ABSL4












List the resources/references used ­­­­­­­­­­­­­­­­­­­­______________________________________________________





2.

BSCs and fume hoods are certified at least annually and records kept for at least three years.

Shape277 Yes

Shape278 No





3.

A sink is present in the laboratory for hand washing.

Shape279 Yes

Shape280 No



If yes, the hand washing sink is hands-free or automatically operated.

Shape281 Yes

Shape282 No





4.

An eyewash station is readily available.

Shape283 Yes

Shape284 No





5.

Liquid effluents originating from the laboratory are collected and heat or chemically treated for sterility prior to exiting the facility or entering a public sewage system.

Shape285 Yes

Shape286 No


If yes,




a.

Are the liquid effluents from the containment shower areas similarly treated for sterility?

Shape287 Yes

Shape288 No


b.

Is the effluent decontamination system validated monthly with a bio-indicator?

Shape289 Yes

Shape290 No





If ABSL3Ag, BSL4 or ABSL4 is selected, proceed to Section 7.





6.

Access to the laboratory is through two consecutive, self-closing doors.

Shape291 Yes

Shape292 No



If yes, door(s) from the anteroom open inward to the laboratory?

Shape293 Yes

Shape294 No




14BSection 6B – Room/Suite Physical Information (Continued)


7.

The ventilation system provides sustained directional airflow by drawing air into the laboratory from “clean” areas toward “potentially contaminated” areas.

Shape295 Yes

Shape296 No





8.

The laboratory is designed such that under failure conditions the airflow will not be reversed.

Shape297 Yes

Shape298 No





9.

Laboratory design and operational parameters are re-verified at least annually.

Shape299 Yes

Shape300 No





10.

A visual monitoring device, which confirms directional airflow, is provided at the laboratory entry.

Shape301 Yes

Shape302 No





11.

Laboratory exhaust is not re-circulated to other areas of the building.

Shape303 Yes

Shape304 No





12.

Exhaust air is HEPA filtered.

Shape305 Yes

Shape306 No


a.

If yes, the HEPA filter housing has decontamination and test ports.

Shape307 Yes

Shape308 No



i.

If this laboratory is a suite, please list rooms with HEPA filtered exhaust : __________________



ii.

HEPA filters and housings are certified at least annually.

Shape309 Yes

Shape310 No


b.

If no, exhaust air is dispersed away from occupied areas and building air intake locations.

Shape311 Yes

Shape312 No





13.

Emergency shower is readily available.

Shape313 Yes

Shape314 No





14.

Floor drains are present.

Shape315 Yes

Shape316 No





15.

Sink traps and any floor drains are filled with water and/or appropriate liquid to prevent the migration of vermin and gases.

Shape317 Yes

Shape318 No





16.

Mechanical cage washer is present.

Shape319 Yes

Shape320 No



If yes, cage washer has a final rinse temperature of at least 180°F.

Shape321 Yes

Shape322 No





17.

The laboratory has a shower-out capability with a change room.

Shape323 Yes

Shape324 No




15BSection 7A – Principal Investigator (PI) Information and Select Agent and Toxin Locations

A complete Section 7 must be submitted for each PI. If separate PI’s would result in an identical Section 7 being completed, multiple PI’s can be listed in the header.


PI

Last Name:

First Name:

DOJ Number:

Date of Birth:

Shape325 Tier 1 Access


Select Agent/Toxin/Regulated Nucleic Acid


Location

Laboratory or Storage

(Select one or both)


Laboratory Safety Level

(Leave blank if storage only)


Bldg

Suite/Room

Lab

Storage




Shape326

Shape327





Shape328

Shape329





Shape330

Shape331





Shape332

Shape333





Shape334

Shape335





Shape336

Shape337





Shape338

Shape339





Shape340

Shape341





Shape342

Shape343





Shape344

Shape345





Shape346

Shape347



Suite Legend:

(If Applicable)

Suite A = Rooms 1, 2, 3, 4

Are any of the rooms grouped as a suite? ....................................................................................... Yes No

If yes, list suite name and rooms in suite. _______________________________________________________




16BSection 7B – Strain or Serotype Designation Information


Select Agent/Toxin/ Regulated Nucleic Acid

Strain or Serotype Designations

Agent







Toxin







Regulated Nucleic Acid




























































17BSection 7C – Description of Work


1.

Provide the objectives of work for each select agent and/or toxin listed in Section 7A by agent/toxin and containment level(s), including a description of the methodologies or laboratory procedures that will be used. Include any work involving animals, arthropods or plants. Attachments A-G must be completed if appropriate for the work described. If no work is being performed with select agent and/or toxin, indicate “storage only”.


Agent/Toxin

BSL

Objective of Work










.

2.

Provide an estimate of the maximum quantities (e.g., number of Petri dishes or total volume of liquid media) and concentration of each organism grown at a given time (e.g., 2 - 250 ml flasks of 105 cfu/ml). If select agent will not be propagated, indicate “no propagation of agent”.



Agent

Maximum Quantity/Concentration










3.

Provide an estimate of the maximum quantity of functional toxin held by the PI at any one time (e.g., 500 mg, 100 ml x 100 ug/ul).



Toxin

Maximum Quantity













4.

Equipment that may produce infectious agent or toxin aerosols (e.g., ultracentrifuge, flow cytometer, cell sorter, plate washer) is contained in primary barrier devices that exhaust air through HEPA filtration or other equivalent technology before being discharged into the laboratory.

Shape348 Yes

Shape349 No




5.

Name(s) of Individual(s) responsible for inventory of select agent(s) and/or toxin(s):












Inventory record is reconciled: Annually Other (specify frequency)_____________





6.

Regulated nucleic acids as defined in 7 CFR 331.3, 9 CFR 121.3, 42 CFR 73.3 or 42 CFR 73.4 are held in long-term storage.

Shape350 Yes

Shape351 No


7.

All cultures, stocks and other regulated wastes are decontaminated prior to disposal.

Shape352 Yes

Shape353 No


If yes, describe method:




Shape354

Autoclaved


Shape355

Chemical (disinfectant, concentration, and time) ___________________________________________


Shape356

Incineration


Shape357

Irradiation


Shape358

Other ______________________________________________________________________________



8.

Written records that would allow someone the ability to gain access to select agent and/or toxin are controlled by:




Shape359

Lock and key


Shape360

Locked filing cabinet, drawer, cabinet, etc.


Shape361

Card access system


Shape362

Other _______________________________________________________________










9.

Will work be performed with:











a.

agents that will be propagated and produce regulated amounts of toxins or with registered toxins at or below the regulated amount?

Shape363 Yes

Shape364 No




If yes, complete Attachment A – Work With Toxins












b.

regulated nucleic acids, genetic modification of select agents or toxins, recombinant/synthetic nucleic acids or recombinant/synthetic organisms?

Shape365 Yes

Shape366 No




If yes, complete Attachment 2 – Work with Regulated Nucleic Acids, Genetic Modification of Select Agents or Toxins, Recombinant/Synthetic Nucleic Acids or Recombinant/Synthetic Organisms











c.

animals?

Shape367 Yes

Shape368 No




If yes, complete Attachment C – Work with Animals











d.

plants?

Shape369 Yes

Shape370 No




If yes, complete Attachment D – Work with Plants











e.

arthropods?

Shape371 Yes

Shape372 No




If yes, complete Attachment E – Work with Arthropods










10.

Will work be performed in:











a.

ABSL3Ag laboratory?

Shape373 Yes

Shape374 No




If yes, complete Attachment F – ABSL3Ag Laboratories











b.

BSL4/ABSL4 laboratory?

Shape375 Yes

Shape376 No




If yes, complete Attachment G – BSL4/ABSL4 Laboratories










18BAttachment A –Work with Toxins



1.

A toxin-specific Chemical Hygiene Plan is available for the laboratory using select toxins.

Shape377 Yes

Shape378 No















2.

Select toxin manipulation or production in the laboratory includes (check all that apply):







Shape379

Dry forms







Shape380

Liquid forms







Shape381

Centrifugation







Shape382

Pressure filtration systems (e.g., chromatography)














3.

Animals are exposed to select toxins.

Shape383 Yes

Shape384 No







a.

If yes, toxin exposure procedure(s) is performed in registered laboratories.

Shape385 Yes

Shape386 No







b.

If yes, complete relevant questions in Attachment C - Work with Animals.

















4.

Select toxin is produced by PI(s).

Shape387 Yes

Shape388 No








If yes, provide a brief description of the method and an estimate of the maximum quantities during production, purification, and concentration.























5.

A hazard sign is posted when select toxins are in use.

Shape389 Yes

Shape390 No















6.

All select toxins, cultures, stock, materials coming into contact with toxins, and other regulated wastes are appropriately inactivated prior to disposal. If yes, describe method:

Shape391 Yes

Shape392 No








Shape393

Autoclaved








Shape394

Chemical (disinfectant, concentration, and time) __________________________________








Shape395

Incineration








Shape396

Other ___________________________________________________________________















7.

Dilution procedures and other manipulations of concentrated select toxins are performed. If yes, conducted in:

Shape397 Yes

Shape398 No








Shape399

Fume hood








Shape400

Biological Safety Cabinet (BSC)








Shape401

Outside of a BSC or fume hood








Shape402

Work is conducted with two knowledgeable people present.

















8.

Select toxins are transferred (intra-entity transfer) to other individuals at the entity outside of the laboratory producing or receiving the toxin (check all that apply):

Shape403 Yes

Shape404 No







If yes, indicate below:









Shape405

Above the aggregate amount









Shape406

Below the aggregate amount

















9.

Select toxins are transferred to other entities in quantities below the aggregate amount
(inter-entity transfer).


Shape407 Yes

Shape408 No





10.

Select toxins are commercially distributed/shipped outside of the laboratory producing the toxin.

Shape409 Yes

Shape410 No








If yes, is there a hazard communication plan?

Shape411 Yes

Shape412 No

















11.

Will work involve possession, use or transfer of recombinant and/or synthetic nucleic acids that encode for the functional form(s) of any select toxins as defined in 42 CFR 73.3 or 42 CFR 73.13?

Shape413 Yes

Shape414 No








If yes, complete Attachment 2 – Work with Regulated Nucleic Acids, Genetic Modification of Select Agents and Toxins, Recombinant/Synthetic Nucleic Acids or Recombinant/Synthetic Organisms.








19BAttachment B – Work with Regulated Nucleic Acids, Genetic Modification of Select Agents or Toxins, Recombinant/Synthetic Nucleic Acids, or Recombinant Synthetic Organisms


1.

Will work involve possession, use, or transfer of the following?






a.

Nucleic acids that can produce infectious forms of select agent viruses.

Shape415 Yes

Shape416 No




b.

Recombinant and/or synthetic nucleic acids that encode for the functional form(s) of any select toxins if the nucleic acids (i) can be expressed in vivo or in vitro or (ii) are in a vector or recombinant host genome and can be expressed in vivo or in vitro.

Shape417 Yes

Shape418 No




c.

Select agent viruses, bacteria, fungi or toxins that have been genetically modified.

Shape419 Yes

Shape420 No










2.

Will work involve the following with select agents and/or toxins:






a.

Introduction and/or modification of genetic elements.

Shape421 Yes

Shape422 No




b.

Recombinant or synthetic nucleic acids.

Shape423 Yes

Shape424 No




c.

Recombinant or synthetic organisms.

Shape425 Yes

Shape426 No




d.

Reverse genetics system to produce infectious forms of select agent viruses, or any complete set of reagents that would allow rescue of infectious virus available for use by a PI at the entity.

Shape427 Yes

Shape428 No










3.

Will a restricted experiment be performed as defined in 42 CFR 73.13, 7 CFR 331.13 or 9 CFR 121.13?

Shape429 Yes

Shape430 No




a.

If yes, please indicate the type of restricted experiment:







Shape431

The introduction of, or selection for, drug resistance trait(s) into select agent organisms.






List the agent(s) and the drug resistance trait(s):








Select Agent ______________________

Drug Resistance Trait ______________






Select Agent ______________________

Drug Resistance Trait ______________






Select Agent ______________________

Drug Resistance Trait ______________





Shape432

The deliberate formation of DNA containing genes for the biosynthesis of toxin lethal for vertebrates at an LD50 < 100 ng/kg body weight.
List toxins _________________________________________________




b.

Has this PI received approval from the APHIS Administrator or HHS Secretary for this restricted experiment?

Shape433 Yes

Shape434 No









4.

Will work involve possession, use or transfer of a product of a restricted experiment?

Shape435 Yes

Shape436 No




a.

If yes, please indicate the type of restricted experiment product:







Shape437

Drug resistance trait(s) in select agent organisms.








List the select agent(s) and the drug resistance trait(s) _______________________





Shape438

DNA containing genes for the biosynthesis of toxin lethal for vertebrates at an LD50 < 100 ng/kg body weight.








List toxin(s) ____________________________________________________




b.

Has this PI received approval from the APHIS Administrator or HHS Secretary for this product of a restricted experiment?

Shape439 Yes

Shape440 No










5.

Will experiments involve the acquisition of increased/restored virulence (e.g., drug resistance, increased host range, enhanced transmissibility, infectivity, environmental stability) in select agents or toxins?

Shape441 Yes

Shape442 No




6.

For any question 1-5 above answered “yes”, provide a brief description of the work. Add additional sheets as needed.










7.

An Institutional Biosafety Committee (IBC) reviews and approves protocols to perform recombinant work with select agents and toxins at this facility.

Shape443 Yes

Shape444 No



If yes, has the IBC approved the work described above?

Shape445 Yes

Shape446 No



If no, please provide an explanation. Add additional sheets as needed.





20BAttachment C – Work with Animals


1.

Provide the select agent/toxin and species of animal to be used:




Select Agent / Toxin

Species of Animal

Route(s) of Administration









2.

Are animals exposed to select agents or toxins by the aerosol route?

Shape447 Yes

Shape448 No



If yes, is the aerosol exposure equipment used within a primary containment device?

Shape449 Yes

Shape450 No



3.

Is the entity waste stream treated prior to disposal?


a.

What is the method of treating carcasses? If yes, answer(check all that apply):

Shape451 Yes

Shape452 No



Shape453

Autoclaved. Describe validation procedures that account for variables such as time and temperature of autoclave run cycles, as well as temperature and weight of carcass at initiation of autoclave cycle. Add additional sheets as needed. ______________________________________________________



Shape454

Chemical (disinfectant, concentration, and time) _______________________________________



Shape455

Incineration



Shape456

Tissue Digester



Shape457

Other ________________________________________________________________________


b.

What is the method of treating infectious waste (e.g., cell cultures, infected arthropods, other biohazardous waste)?



Shape458

Incineration



Shape459

Autoclaved: Describe validation procedures that account for variables such as time and temperature of autoclave run cycles. ____________________________________________________________


4.


Are samples (tissue, blood, nucleic acids, etc.) from exposed or infected animals manipulated at a lower biosafety level?

If yes, describe the inactivation process (e.g. formalin fixation, lysis of cells for nucleic acid extraction, irradiation) for the samples. Include concentration or dosage and contact/exposure time, as applicable.


Shape460 Yes


Shape461 No





5.

The entity requires that an Institutional Animal Care and Use Committee (IACUC) review and approve protocols prior to work with animals at this entity.

Shape462 Yes

Shape463 No



If yes, the proposed work with select agents and toxins in animals has been approved by the IACUC. If no, explain. Add additional sheets as needed. _____________________

Shape464 Yes

Shape465 No


6.

The laboratory is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).

Shape466 Yes

Shape467 No




If yes, give most recent (re)accreditation date ____________________







7.

There is a system in place for recording the number of animals infected, the number of animals disposed of, and the records are reviewed frequently.

Shape468 Yes

Shape469 No




If yes, describe. _______________________________________________





8.

Shape471 Shape470 Are animals restrained for experimental manipulation? Yes No




If no, explain. _________________________________________________



9.

Shape473 Shape472 Are animals intentionally or accidently infected with select agents monitored (e.g., daily checks)? Yes No




If no, explain. __________________________________________________
















10.

Describe animal housing for each species, including whether cages provide primary containment and a brief description (e.g. cage or cage rack is HEPA filtered, active or passive ventilation of the cages, non-containment caging housed within inward flow ventilated enclosure). For active ventilation caging, indicate whether or not the system is equipped to indicate operational malfunctions.



Species


Animal Housing


















11.

Are animals euthanized?

If no, explain. _____________________________________________________

Shape474 Yes

Shape475 No







12.

Will animals be necropsied?

Shape476 Yes

Shape477 No




If yes, describe necropsy procedures. _____________________________________









13.

Describe how animal carcasses are secured prior to decontamination.





Shape478

Locked freezers, coolers



Shape479

Not secured, immediately decontaminated (e.g., autoclave, tissue digester, incinerator)



Shape480

Other _____________________________________________________



21BAttachment D – Work with Plants


1.

Provide the select agent and species of plant to be used:

Select Agent

Species of Plant

Route(s) of Inoculation














2.

Plant waste is treated prior to disposal (e.g., soil, plant material, materials accompanying plants or samples) by an approved method (check all that apply):

Shape481 Yes

Shape482 No


Shape483

Autoclaved


Shape484

Chemical (disinfectant, concentration, and time) ____________________________


Shape485

Irradiation


Shape486

Incineration


Shape487

Other ______________________________________________________________





3.

Are vectors present?

Shape488 Yes

Shape489 No


a.

Vectors are restricted to cages?

Shape490 Yes

Shape491 No


b.

Are adjacent areas monitored to observe potential escapes?

Shape492 Yes

Shape493 No


c.

Please describe vector species and cage mesh size _________________________


d.

Are vectors exposed to select agents or plants infected with select agents?

Shape494 Yes

Shape495 No




If yes, complete Attachment E - Work with Arthropods.







4.

Will plants exposed to select agents be housed or manipulated in a glass house?

Shape496 Yes

Shape497 No


a.

Is the glass house attached to the laboratory?

Shape498 Yes

Shape499 No


b.

Is the glass house separated from the laboratory?

Shape500 Yes

Shape501 No


c.

Is pest monitoring conducted within the glass house?

Shape502 Yes

Shape503 No


d.

Are inoculated plants moved between areas such as glass house to laboratory?

Shape504 Yes

Shape505 No


e.

Structure is reinforced.

Shape506 Yes

Shape507 No


f.

Floor is constructed of:





Shape508

Concrete





Shape509

Tile or other floor covering





Shape510

Dirt or gravel







5.

Will plants exposed to select agents be housed or manipulated in a greenhouse?

Shape511 Yes

Shape512 No


a.

Is the greenhouse attached to the laboratory?

Shape513 Yes

Shape514 No


b.

Is the greenhouse separated from the laboratory?

Shape515 Yes

Shape516 No


c.

Is pest monitoring conducted within the greenhouse?

Shape517 Yes

Shape518 No


d.

Are inoculated plants moved between areas such as greenhouse to laboratory?

Shape519 Yes

Shape520 No


e.

Structure is reinforced.

Shape521 Yes

Shape522 No


f.

Floor is constructed of:





Shape523

Concrete





Shape524

Tile or other floor covering





Shape525

Dirt or gravel




6.

Will plants exposed to select agents be housed or manipulated in a screenhouse?

Shape526 Yes

Shape527 No


a.

Is the screenhouse attached to the laboratory?

Shape528 Yes

Shape529 No


b.

Is the screenhouse separated from the laboratory?

Shape530 Yes

Shape531 No


c.

Is pest monitoring conducted within the screenhouse?

Shape532 Yes

Shape533 No


d.

Are inoculated plants moved between areas such as screenhouse to laboratory?

Shape534 Yes

Shape535 No


e.

If yes, provide a description of the screenhouse materials (including screen mesh size) _________________________________________________




f.

Structure is reinforced.

Shape536 Yes

Shape537 No


g.

Floor is constructed of:





Shape538

Concrete





Shape539

Tile or other floor covering





Shape540

Dirt or gravel







7.

Will plants exposed to select agents be housed or manipulated in a growth chamber?

Shape541 Yes

Shape542 No


a.

Is the growth chamber located in or attached to the laboratory?

Shape543 Yes

Shape544 No


b.

Is the growth chamber separated from the laboratory?

Shape545 Yes

Shape546 No


c.

Is pest monitoring conducted within the growth chamber?

Shape547 Yes

Shape548 No


d.

Are inoculated plants moved between areas such as growth chamber to laboratory?

Shape549 Yes

Shape550 No


e.

Structure is reinforced.

Shape551 Yes

Shape552 No


f.

Floor is constructed of:





Shape553

Concrete





Shape554

Tile or other floor covering





Shape555

Dirt or gravel




g.

Manufacturer name _____________________________________________

Model number _________________________________________________


h.

Access to growth chamber is controlled (e.g., lock and key, card access system, biometrics).

Shape556 Yes

Shape557 No


i.

Is the growth chamber located at a reasonable distance from other growth chambers with healthy plants, insectaries and outside doors?

Shape558 Yes

Shape559 No






8.

Will work be performed with regulated nucleic acids, genetic modification of select agents or toxins, recombinant/synthetic nucleic acids or recombinant/synthetic organisms?

Shape560 Yes

Shape561 No



If yes, complete Attachment B – Work with Regulated Nucleic Acids, Genetic Modification of Select Agents or Toxins, Recombinant/Synthetic Nucleic Acids or Recombinant/Synthetic Organisms.








22BAttachment E – Work with Arthropods




1.

Work is performed with field-collected arthropods in a diagnostic capacity only for identification of select agents.

Shape562 Yes

Shape563 No





2.

Work is performed to experimentally inoculate or infect arthropods (any stages) with select agents. If yes, complete questions 3-16.

Shape564 Yes

Shape565 No








3.

Provide the select agent and species of arthropod used:


Select Agent

Species of Arthropod













4.

Arthropod experimental exposure route(s).





a.

Injected with select agent.

Shape566 Yes

Shape567 No



b.

Infected with select agent via blood meal.

Shape568 Yes

Shape569 No




If yes, indicate the blood meal source.






Shape570

Animal species __________________________________________





If vertebrate hosts are used, has the IACUC approved the work proposed in this objective of work?

Shape571 Yes

Shape572 No





If yes, complete Attachment C - Work with Animals.





If no, explain. Add additional sheets as needed. ______________________




Shape573

Collected blood (describe type/method) _____________________________



c.

Infected with select agent via insect feeding on select agent infected plants.

Shape574 Yes

Shape575 No




If yes, complete Attachment D - Work with Plants.



d.

Other (Describe)_________________________________________________


5.

Provide a description of the procedures used for primary containment and any transfer(s) of infected arthropods. __________________________________________________









6.

There is a system in place for recording the number of arthropods infected and the number of arthropods disposed of, and the records are reviewed frequently.

Shape576 Yes

Shape577 No




If yes, describe. ___________________________________________









7.

Arthropod containment laboratory design and operational procedures are developed and implemented in accordance with guidance found in the current edition of the Arthropod Containment Guidelines, a project of the American Committee of Medical Entomology of the American Society of Tropical Medicine and Hygiene.

Shape578 Yes

Shape579 No






8.

An Institutional Biosafety Committee (IBC) reviews and approves arthropod work with select agents at this facility.

Shape580 Yes

Shape581 No



If yes,





a.

has the IBC approved the arthropod containment laboratory design and operational procedures?

Shape582 Yes

Shape583 No



b.

has the IBC approved the work described in this objective of work?

Shape584 Yes

Shape585 No



If no, explain. _______________________________________________










9.

Are arthropods, including those experimentally infected, housed and manipulated in a suite/room such that accidental contact and release is prevented?

Shape586 Yes

Shape587 No








10.

Do protocols account for accidental escape?

Shape588 Yes

Shape589 No








11.

Ventilation filters/barriers are installed to prevent arthropod escape.

Shape590 Yes

Shape591 No








12.

Floor drains are present in the laboratory.  

Shape592 Yes

Shape593 No




If yes, floor drains are modified to prevent accidental release of arthropods and agents.

Shape594 Yes

Shape595 No








13.

Suite/room plumbing is suitable to prevent arthropod escape.

Shape596 Yes

Shape597 No








14.

All stages of arthropods are killed before disposal.

Shape598 Yes

Shape599 No








15.

All wastes from the arthropod containment laboratory are treated for disposal using an approved method.

Shape600 Yes

Shape601 No




If yes, describe method:






Shape602

Autoclaved




Shape603

Chemical (disinfectant, concentration, and time)_________________________




Shape604

Incineration




Shape605

Other __________________________________________________________





16.

Animals or plants are permitted in the arthropod containment laboratory.

Shape606 Yes

Shape607 No



If yes,





a.

are animals or plants associated with the work being performed?

Shape608 Yes

Shape609 No



b.

are animals or plants accessible to escaped arthropods?

Shape610 Yes

Shape611 No




23BAttachment F – ABSL3Ag Laboratories


1.

Supplies, material and equipment enter and exit ABSL3Ag areas only through an airlock, fumigation chamber, an interlocked and double-door autoclave, or shower.

Shape612 Yes

Shape613 No



For materials and equipment that cannot be decontaminated in the autoclave, a pass-through dunk tank, fumigation chamber, or equivalent decontamination method is available.

Shape614 Yes

Shape615 No





2.

Is a shower required when leaving the containment boundary

Shape616 Yes

Shape617 No






3.

Disposable materials are decontaminated by a verified method (check all that apply):

Shape618 Yes

Shape619 No


Shape620

Autoclaved




Shape621

Chemical (disinfectant, concentration, and time) _____________________________


Shape622

Incineration __________________________________________________________


Shape623

Other _______________________________________________________________





4.

All containment areas are designed, constructed and verified to function as a primary containment barrier. All walls are constructed slab-to-slab and walls, floors, and ceilings are sealed. All penetrations into the laboratory are sealed airtight to prevent escape of agents and to allow fumigation for biological decontamination.

Shape624 Yes

Shape625 No





5.

Differential pressures/directional airflow are monitored and alarmed to indicate system failure.

Shape626 Yes

Shape627 No





6.

There are two HEPA filters installed in series prior to air being exhausted from the containment space. Supply air passes through ductwork with a HEPA filter and/or fast acting bioseal (i.e., bubble tight) damper that fails in the closed position.

Shape628 Yes

Shape629 No



If yes, all HEPA filters are certified annually.

Shape630 Yes

Shape631 No





7.

Laboratory procedure and design features include:




a.

Entrance into the facility is through an interlocking double door vestibule that separates containment areas from non-containment areas.

Shape632 Yes

Shape633 No


b.

A clean change room outside of containment.

Shape634 Yes

Shape635 No


c.

Doors that define a containment boundary are sealed and verified airtight through pressure decay testing.

Shape636 Yes

Shape637 No


d.

A shower room at the non-containment/containment boundary.

Shape638 Yes

Shape639 No


e.

A dirty change room within containment.

Shape640 Yes

Shape641 No





8.

A second shower is required at the facility access control point before donning street clothing.

If no, describe the alternate strategies used to satisfy the BMBL 6th edition.

Shape642 Yes

Shape643 No















9.

Necropsy rooms are sized and equipped to accommodate large animals.

Shape644 Yes

Shape645 No


If yes, describe. Add additional sheets as needed. _____________________________






24BAttachment G – BSL4/ABSL4 Laboratories


BSL4 Laboratory


1.

Will work be performed in a BSL4/ABSL4 Cabinet Laboratory?

Shape646 Yes

Shape647 No



If yes, complete questions 2 - 8


2.

Describe the type of personal protective equipment that will be used. Add additional sheets as needed.


3.

Describe the decontamination methods for materials/equipment in the Class III cabinet. Add additional sheets as needed.


4.

Describe what liquid effluents are decontaminated and how they are decontaminated. Add additional sheets as needed.


5.

Describe the supply and exhaust components of the ventilation system, including how the ventilation system of the Class III cabinet is manifolded to the room ventilation. Add additional sheets as needed.


6.

In the event of a ventilation failure, describe what measures are used to prevent reversal of airflow. Add additional sheets as needed.


7.

Describe how differential pressures and directional airflow are monitored and analyzed. Add additional sheets as needed.


8.

Describe how containment parameters are monitored daily. Add additional sheets as needed.


9.

Will work be performed in a BSL4/ABSL4 Suit Laboratory?

Shape648 Yes

Shape649 No



If yes, complete questions 10 - 16


10.

Describe the type of personal protective equipment that will be used. Add additional sheets as needed.


11.

Describe what liquid effluents are decontaminated and what measures are used to do so. Add additional sheets as needed.


12.

Describe the supply and exhaust components of the ventilation system, including how negative pressure is maintained and HEPA filtration of supply and exhaust air. Add additional sheets as needed.


13.

In the event of a ventilation failure, describe what measures are used to prevent reversal of airflow. Add additional sheets as needed.


14.

Describe how differential pressures and directional airflow are monitored and analyzed. Add additional sheets as needed.


15.

In the event of a breathing air failure, describe what facility redundancies are in place. Add additional sheets as needed.


16.

Describe how containment parameters are monitored daily. Add additional sheets as needed.






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AuthorKowalski, Matthew (CDC/OPHPR/DSAT) (CTR)
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