Attachment 3a - Original Application for Registration Form

Attachment 3-APHIS-CDC Form 1.pdf

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

Attachment 3a - Original Application for Registration Form

OMB: 0920-0576

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GUIDANCE DOCUMENT FOR APPLICATION FOR
REGISTRATION FOR POSSESSION, USE, AND TRANSFER OF
SELECT AGENTS AND TOXINS
(APHIS/CDC FORM 1)

FORM APPROVED
OMB NO. 0579-0213
OMB NO. 0920-0576
EXP DATE 12/31/2008

INTRODUCTION
The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules (7 CFR 331, 9 CFR 121,
and 42 CFR 73), which implement the provisions of the Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (Public Law 107-188) setting forth the requirements for possession, use, and transfer of select agents and toxins. The
select agents and toxins identified in the final rules have the potential to pose a severe threat to public health and safety, to animal
and plant health, or to animal and plant products. Responsibility for providing guidance on this form was designated to the Centers
for Disease Control and Prevention (CDC) by the HHS Secretary and to the Animal and Plant Health Inspection Service (APHIS)
by the USDA Secretary. In order to minimize the reporting burden to the public, APHIS and CDC have developed a common
reporting form for this data collection.
Unless exempted from the requirements set forth in 7 CFR 331, and 9 CFR 121, and 42 CFR 73, an individual or entity shall not
possess, use, or transfer any select agent or toxin without a certificate of registration issued by APHIS or CDC. To apply for a
certificate of registration, an individual or entity must submit the information requested in the registration application package
(APHIS/CDC Form 1) to APHIS or CDC based on the type of select agent or toxin they may possess, use, or transfer. For HHS
agents, the Responsible Official (RO) should submit this form to CDC (telephone: 404-718-2000, facsimile: 404-718-2096, or email: lrsat@cdc.gov). For USDA agents, the RO should submit this form to APHIS (telephone: 301-734-5960, facsimile: 301-7343652, e-mail: Agricultural.Select.Agent.Program@aphis.usda.gov). For HHS/USDA overlap agents, the RO may submit this form
to APHIS or CDC, but not both. A listing of HHS select agents and toxins is available at http://www.cdc.gov/od/sap. A listing of
USDA select agents and toxins is available at http://www.aphis.usda.gov/programs/ag_selectagent/index.html. Before you
complete this application, please review the exemption and exclusion requirements set forth in 7 CFR 331, and 9 CFR 121, and 42
CFR 73 to determine whether your entity is required to register.
The entity should also perform a facility risk assessment (see 7 CFR 331.11-12, 9 CFR 121.11-12, and 42 CFR 73.11-12) that is
based on the requirements for handling that agent to ensure that the facility meets those requirements. All entities using select
agents and toxins should base their facility risk assessments on the applicable sections of the Biosafety in Microbiological and
Biomedical Laboratories (BMBL), NIH Guidelines for Research Involving Recombinant DNA (NIH Guidelines), 29 CFR 1910.1450,
or other required assessment materials. If information supplied in the application package indicates that the entity is properly
equipped and capable of handling select agents and toxins, APHIS or CDC may issue a registration certificate to the entity. The
registration is valid for a period up to three years. All entities will be subject to inspection during the three-year registration period.
If an entity’s application fails to document that the entity is properly equipped and capable of work with select agents and toxins, or
if the application is incomplete, the entity will not be registered. APHIS or CDC will inform the entity of problems with the application
by contacting the designated RO. Upon resolution of the problem, the entity may again seek registration. Allow at least 8 weeks for
processing. Submission of an incomplete application will result in a significant delay in processing the application. Currently, there
is no fee for registration for select agents and toxins.
PURPOSE
The purpose of this form is to provide a method for entities to register to possess, use, or transfer select agents and toxins as
described in 7 CFR 331.7, 9 CFR 121.7, and 42 CFR 73.7. The information requested in this form includes: facility information; a
list of select agents or toxins to be possessed, used, or transferred by the entity; a list of individual who will have access to select
agents and toxins; characterization of the select agents and toxins and additional laboratory information.
INSTRUCTIONS
(A) Designating a RO and alternate RO
The entity is required by the regulations to assign a RO to assume responsibility for providing application information to APHIS or
CDC. The RO must have the authority and responsibility to act on behalf of the entity, ensure compliance with the requirements of
7 CFR 331, 9 CFR 121, and 42 CFR 73, and must be approved based on a security risk assessment by the Attorney General
(Public Act 212(e)(3)). The purpose of the RO is to provide an established point of contact for the entity if APHIS or CDC has
questions concerning the application or other matters related to the entity registration. The RO should consult with others (e.g.,
engineering support services, principal investigators, biosafety officers) as necessary to obtain the information required for this
application.
An entity may also designate an alternate RO in cases where extended absences or other circumstances warrant acting for the RO
in his or her absence. The alternate RO must meet all of the qualifications for a RO. We recommend that the RO and alternate RO

are biosafety officers or senior management officials of the entity, or both. Although we understand that some entities have limited
staff, we recommend that the RO not be an individual actually using, working with, or transferring or receiving the select agents and
toxins to minimize potential conflicts of interest.
To designate a different RO or an alternate RO, the current RO must mail or fax to the appropriate agency a signed statement on
official entity facility letterhead requesting such changes. In addition, the new RO or alternate RO must submit completed Sections
1 and 2.
In the event that an entity loses the services of its Responsible Official, an entity may continue to possess or use select agents or
toxins only if it appoints as the Responsible Official another individual who has been approved by the APHIS Administrator or HHS
Secretary following a security risk assessment by the Attorney General and who meets the requirements of this part. The owner of
the entity must mail or fax to the appropriate agency a signed statement on official entity facility letterhead requesting such
changes. In addition, the new RO or alternate RO must submit Sections 1 and 2.
(B) Completing Application
1.

Submission of an incomplete or illegible application will result in a significant delay in processing the application.

Section 1 – Entity Information
a. Complete section 1 regarding entity, RO, and alternate RO information.
b. If more than one alternate RO has been identified, additional sections 1C and 2 should be completed, as appropriate.
c. If the entity was previously registered with APHIS or CDC, section 1D should be completed.

Section 2 – Certification and Signature form. This section must be completed and signed by the RO and all alternate RO(s) for
the institution.

Section 3 – Select Agents and Toxins, Possessed, Used, or Transferred by Entity. Complete section to indicate each select
agent or toxin which is currently in possession, use or in storage at the entity, or those agents that are anticipated in the near
future (e.g., within 6 months).

Section 4A – Biosafety and Laboratory Information on Select Agents and Toxins.
a. The following information must be listed on a separate line for each laboratory safety level: the select agent(s) or toxin(s);
the type of work with each select agent or toxin (e.g., viable, genomic material, recombinant DNA, use in animals, or large
scale), the building and room number(s) where select agent(s) or toxin(s) will be used and stored for each Principal
Investigator (or Chief Scientist).
b. The facility risk assessment based on the requirements for the type of activities conducted with each select agent and
toxin in each of the rooms should be listed in the “Laboratory Safety Level” column.

Example 1. An entity needs to register one principal investigator (e.g., Dr. Jane Doe will be working with viable Bacillus anthracis
in Bldg A, Room 2 at BSL-2; large scale production of Bacillus anthracis in Bldg A, Room 5 at BSL3; and Bacillus anthracis in mice
in Bldg B, Room 200 at ABSL2). Storage of the select agents will be in the same locations where the work will be conducted.
EXAMPLE 1
Select
agent/Toxin
name

Bacillus
anthracis
Bacillus
anthracis
Bacillus
anthracis

Viable

Genomic
material

Recombinant
DNA

Animal

Large
Scale

X
X
X

X
X

Toxin

Laboratory
Area
Bldg Room

Laboratory
Safety
Level
Room

Storage Area
Bldg

Principal
Investigator

BSL2

Dr. Jane Doe

BSL3

Dr. Jane Doe

200

ABSL2

Dr. Jane Doe

Example 2. An entity needs to register three principal investigators (e.g., Dr. John Smith will be working with recombinant Ebola in
Bldg 15, Room 100 at NIHBL-4; Dr. Mary Johnson will be working with botulinum toxins in Bldg 3A, Room 1000 under 29 CFR
1910.1450 conditions; and Dr. Tony Small will be working with viable Francisella tularensis in Bldg 4, Room 300 at BSL3 and
viable Brucella melitensis in the same room). Storage of the agents will be in the same locations where the work will be conducted.
EXAMPLE 2
Select
agent/Toxin
name

Ebola virus
Botulinum
toxin
Francisella
tularensis
Brucella
melitensis
6.

Viable

Genomic
material

Recombinant
DNA

Animal

Large
Scale

Toxin

Laboratory
Area
Bldg Room

Storage Area
Bldg Room

Laboratory
Safety Level

Principal
Investigator

Dr. John Smith
Dr. Mary
Johnson

100

NIHBL4

1000

29 CFR

300

BSL3

Dr. Tony Small

300

BSL3

Dr. Tony Small

Section 4B – Authorized Personnel Working with Select Agents and Toxins. Complete this section by providing the
information for the RO, alternate RO, owners of the entity, as well as each person who is authorized to have access to select
agents and toxins at the entity.
a. The name (including middle initial), the date of birth and address, (including zip code) for individuals listed on this table
should be identical to that given on the FBI form (FD-961) submitted to the Federal Bureau of Investigation (FBI), Criminal
Justice Information Services Division (CJIS) for each individual. The first and last name of each individual should
correspond exactly to the information submitted to CJIS.
b. The “Principal Investigator” (PI) field on Table 4B refers to the individual who is supervising all activities associated with
select agents and toxins in the specified rooms. Therefore, the PI listed in Table 4B must be a PI listed on Table 4A. This
column should be left blank only for the RO, ARO, PI, and owner/controller of the entity.
c. Amending Section 4B:
1) To request additions to Section 4B, submit an amended Section 4B with the individual’s information added to the same
agency that you filed your original application with (APHIS or CDC).
2) To request deletions to Section 4B, submit the Section 4B with the individual’s information lined through or removed (if
removed, include a cover letter indicating which individual’s information was removed) to the same agency that you
filed your original application with (APHIS or CDC). If the individual’s access to select agents or toxins is terminated
by the entity, the RO must submit the reason for termination along with the amended Section 4B.
d. Submitting security risk assessment (SRA) information to CJIS:
1) Once the entity has submitted an amended Section 4B listing new persons requiring an SRA, the RO receives the
individual’s unique Department of Justice (DOJ) identifying number from APHIS or CDC and forwards to the individual
to complete the SRA information (FD-961 form and fingerprint cards).
2) The individual should complete the FD-961 form including their unique DOJ identifying number in block 15 and follows
the FBI instructions (http://www.fbi.gov/hq/cjisd/takingfps.html) for submitting fingerprints. The FD-961 form and
fingerprint cards should be mailed as one package directly to CJIS, not to APHIS or CDC. Specific guidance on the
process is available at http://www.cdc.gov/od/sap, http://www.aphis.usda.gov/programs/ag_selectagent/index.html, or
http://www.fbi.gov/terrorinfo/bioterrorfd961.htm.

Example 3. John Johnson will be working with viable Bacillus anthracis in Bldg A, Room 2 at BSL-2 in Dr. Jane Doe’s laboratory.
Although Dr. Jane Doe may not be his immediate supervisor, her name should be listed because she is responsible for the select
agent in this laboratory.
Home
Address
(No P.O. boxes)

Last Name

First
Name

Middle
Initial

Date of
Birth

Doe

Jane

1/1/61

123 Street
City, ST 01234

Johnson

John

1/2/60

456 Lane
City, ST 01234

Principal
Investigator
(PI’s, RO’s,
ARO’s, and
owners leave
this column
blank)

Doe

Select
Agent(s)/
Toxin(s)

Laboratory
Building

Laboratory
Room

Bacillus
anthracis

Principal
Investigator

Bacillus
anthracis

Laboratorian

Job Title

7. Section 5 – Principal Investigator and Laboratory Information. Complete this section for each principal investigator and each
laboratory at the entity. Complete only sections as appropriate for the select agents and toxins in use for each principal
investigator. If statement does not apply to the laboratory, check “N/A” box (if box is not available, write “N/A” beside
statement).

To apply for a certificate of registration that covers only HHS select agents or toxins, an entity must submit the application
package to CDC.
To apply for a certificate of registration that covers only USDA select agents or toxins, an entity must submit the
application package to APHIS.
To apply for a certificate of registration that does not cover only HHS select agents or toxins (i.e., covers at least one
overlap select agent and toxin, or covers any combination of HHS select agents and toxins and USDA select agents and
toxins), an entity must submit the application package to APHIS or CDC, but not both.

(D) Amending certification of registration
The RO or his or her alternate RO are also responsible for notifying APHIS or CDC of any changes to the registration, such as
modifications to authorized laboratory personnel, changes in currently registered laboratories, additional new laboratories that
require registration, or any other changes to the information provided in this application. Prior to any change, the RO must apply
for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application and forwarding it
to APHIS or CDC for approval.
FACILITY RISK ASSESSMENTS AND SAFETY LEVELS: REQUIREMENTS FOR HANDLING SELECT AGENTS
All entities using select agents should base their facility risk assessments on the applicable sections of the Biosafety in
Microbiological and Biomedical Laboratories (BMBL), NIH Guidelines for Research Involving Recombinant DNA (NIH Guidelines),
29 CFR 1910.1450, or other required assessment materials.
• Laboratories working with viable select agent viruses, bacteria, or fungi should base their facility risk assessments on the
BMBL. Use the BMBL to determine the appropriate Biosafety Level (BSL) for the various types of work to be conducted with
each of the select agents.
• Laboratories working with recombinant DNA or regulated genetic elements should base their facility risk assessment on the NIH
Guidelines to determine the recommended Biosafety Level (BSL) for the type of work to be conducted with each of the select
agents. Institutions using recombinant DNA for large animal studies or in large scale production should base their facility risk
assessments on the NIH Guidelines, as there are no corresponding sections in the BMBL.
• Laboratories working with select agent toxins should meet the requirements of 29 CFR 1910.1450, Occupational Exposure to
Hazardous Chemicals in Laboratories. Additional guidance regarding toxin may be found in the BMBL. If the entity is also
working with viable select agent toxin-producing organisms or recombinant DNA encoding for select agent toxins, the laboratory
should base its facility risk assessments on the BMBL and NIH Guidelines in addition to 29 CFR 1910.1450.
• Distributors of toxins in which the toxins are only handled in sealed containers should meet the requirements of 29 CFR
1910.1200, Hazard Communication.
ADDITIONAL REFERENCE MATERIALS:
(1) Biosafety in Microbiological and Biomedical Laboratories (BMBL). The BMBL is available on the internet at
http://www.cdc.gov/od/sap. An errata sheet for the most current edition of the BMBL is available at the internet website:
http://www.cdc.gov/od/sap.
(2) NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). The NIH Guidelines are available at
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.
(3) 29 CFR 1910.1450 - Occupational Exposure to Hazardous Chemicals in the Laboratory. Available on the Internet at
http://www.osha.gov or from the U.S. Government Printing Office (phone 202-512-1800).
(4) 29 CFR 1200 - Hazard Communication. Available on the Internet at http://www.osha.gov or from the U.S. Government Printing
Office (phone 202-512-1800).
(5) Additional information and clarification is available at http://www.cdc.gov/od/sap and
http://www.aphis.usda.gov/programs/ag_selectagent/index.html.
OBTAINING EXTRA COPIES OF THIS FORM
Additional copies of this form are available on the APHIS website (http://www.aphis.usda.gov/programs/ag_selectagent/index.html)
or the CDC website (http://www.cdc.gov/od/sap) or by contacting APHIS at (301) 734-5960 or CDC at (404) 718-2000.

APPLICATION FOR
REGISTRATION FOR POSSESSION, USE, AND TRANSFER OF
SELECT AGENTS AND TOXINS
(APHIS/CDC FORM 1)

FORM APPROVED
OMB NO. 0579-0213
OMB NO. 0920-0576
EXP DATE 12/31/2008

Read all instructions carefully before completing the application. Answer all items completely and type or print in ink. Failure to
complete this application in detail will delay processing of your application. This report must be signed and submitted to either
APHIS or CDC:
Animal and Plant Health Inspection Service
Agricultural Select Agent Program
4700 River Road Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737
FAX: 301-734-3652

Centers for Disease Control and Prevention
Division of Select Agents and Toxins
1600 Clifton Road NE, Mailstop A-46
Atlanta, GA 30333
FAX: 404-718-2096

SECTION 1 – ENTITY INFORMATION (TO BE COMPLETED BY ALL RO’S)
This application is:
A new registration
An amendment to an existing registration
SECTION 1A– ENTITY INFORMATION

Entity registration number (e.g., A00000000-0000):

Date:

Legal name of entity:
Address (NOT a post office box):
Type of entity:

City:

Academic (Private)
Government (Federal)

Academic (State)
Government (State/Local)

State:

Zip Code:

Commercial (Profit)
Private (Non-Profit)

SECTION 1B– RESPONSIBLE OFFICIAL INFORMATION

Name of Responsible
Official:
Date of birth:

Last Name:

First Name:

Middle Name:

Title of Responsible Official (e.g., biosafety officer):

Business Telephone:

Business FAX:

Business E-mail:

Business Address (NOT a post office box):

City:

State:

Zip Code:

SECTION 1C – ALTERNATE RESPONSIBLE OFFICIAL INFORMATION

Name of Alternate
Responsible Official:
Date of birth:

Last Name:

First Name:

Title of Alternate Responsible Official (e.g., biosafety officer):

Business Telephone:

Business FAX:

Business E-mail:

Business Address (NOT a post office box):
Name of Alternate
Responsible Official:
Date of birth:

Middle Name:

City:

Last Name:

Business Telephone:
Business Address (NOT a post office box):

State:

First Name:

Middle Name:

Title of Alternate Responsible Official (e.g., biosafety officer):
Business FAX:

Business E-mail:
City:

State:

SECTION 1D – REGISTRATION HISTORY
Has this entity previously been registered with the Select Agent Program?
Yes
if yes, then provide Select Agent Program registration number and expiration date:

Zip Code:

SECTION 2 – CERTIFICATION AND SIGNATURE
(TO BE COMPLETED BY ALL RO’S AND ALTERNATE RO’S)
I hereby certify that I have been designated as the Responsible Official or the Alternate Responsible Official 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 C.F.R. Part 73 and/or 7 C.F.R. Part 331 and/or 9 C.F.R. 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 C.F.R. Part 73
and/or 7 C.F.R. Part 331 and/or 9 C.F.R. Part 121.
I understand that submission of a false statement and/or failure to comply with the provisions of the applicable regulations (7
C.F.R. Part 331 and/or 9 C.F.R. Part 121 and/or 42 C.F.R. Part 73) 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 U.S.C. 8401; 18 U.S.C. 175, 175B, 1001, 3559, 3571; 42 U.S.C. 262a).

______________________________________
Responsible Official Signature

______________________________________
Alternate Responsible Official Signature

___________
Date

__________________________________________
Responsible Official Name (typed or printed)

___________________________________________
Alternate Responsible Official Name (typed or printed)

Date:__________

SECTION 3 – SELECT AGENTS AND TOXINS POSSESSED, USED, OR TRANSFERRED BY ENTITY
(TO BE COMPLETED BY ALL RO’S)

Indicate each select agent or toxin that your entity intends to register by placing an “X” in the box for each agent or toxin (check
one or more as appropriate). Select agents or toxins that are exempt or excluded from registration should not be listed on this form.
For information on completing this section, refer to page 2 of the guidance document.
HHS SELECT AGENTS AND TOXINS
Abrin
Cercopithecine herpesvirus 1 (Herpes B virus)
Coccidioides posadasii
Conotoxins
Crimean-Congo haemorrhagic fever virus
Diacetoxyscirpenol
Ebola virus
Lassa fever virus
Marburg virus
Monkeypox virus
Reconstructed replication competent forms of the 1918
pandemic influenza virus containing any portion of the
coding regions of all eight gene segments (Reconstructed
1918 Influenza virus)
Ricin
Rickettsia prowazekii
Rickettsia rickettsii
Saxitoxin
Shiga-like ribosome inactivating proteins
South American Haemorrhagic Fever viruses
Flexal
Guanarito
Junin
Machupo
Sabia
Tetrodotoxin
Tick-borne encephalitis complex (flavi) viruses
Central European Tick-borne encephalitis
Far Eastern Tick-borne encephalitis
Kyasanur Forest disease
Omsk Hemorrhagic Fever
Russian Spring and Summer encephalitis
Variola major virus (Smallpox virus)
Variola minor virus (Alastrim)
Yersinia pestis
OVERLAP SELECT AGENTS AND TOXINS
Bacillus anthracis
Botulinum neurotoxins
Botulinum neurotoxin producing species of Clostridium
Brucella abortus
Brucella melitensis
Brucella suis
Burkholderia mallei (formerly Pseudomonas mallei)
Burkholderia pseudomallei (formerly Pseudomonas pseudomallei)
Clostridium perfringens epsilon toxin
Coccidioides immitis
Coxiella burnetii
Eastern Equine Encephalitis virus
Francisella tularensis
Hendra virus
Nipah virus
Rift Valley fever virus
Shigatoxin
Staphylococcal enterotoxins
T-2 toxin
Venezuelan Equine Encephalitis virus

USDA SELECT AGENTS AND TOXINS
African horse sickness virus
African swine fever virus
Akabane virus
Avian influenza virus (highly pathogenic)
Bluetongue virus (Exotic)
Bovine spongiform encephalopathy agent
Camel pox virus
Classical swine fever virus
Cowdria ruminantium (Heartwater)
Foot-and-mouth disease virus
Goat pox virus
Japanese encephalitis virus
Lumpy skin disease virus
Malignant catarrhal fever virus
(Alcelaphine herpesvirus type 1)
Menangle virus
Mycoplasma capricolum/ M.F38/M. mycoides Capri
(contagious caprine pleuropneumonia)
Mycoplasma mycoides mycoides
(contagious bovine pleuropneumonia)
Newcastle disease virus (velogenic)
Peste des petits ruminants virus
Rinderpest virus
Sheep pox virus
Swine vesicular disease virus
Vesicular stomatitis virus (Exotic)
USDA PLANT PROTECTION AND QUARANTINE (PPQ)
SELECT AGENTS AND TOXINS
Candidatus Liberobacter africanus
Candidatus Liberobacter asiaticus
Peronosclerospora philippinensis
Ralstonia solanacearum race 3, biovar 2
Schlerophthora rayssiae var zeae
Synchytrium endobioticum
Xanthomonas oryzae pv. oryzicola
Xylella fastidiosa (citrus variegated chlorosis strain)

SECTION 4 – SELECT AGENT AND TOXIN INFORMATION
(TO BE COMPLETED BY ALL RO’S)

SECTION 4A. BIOSAFETY AND LABORATORY INFORMATION ON SELECT AGENTS AND TOXINS
Provide the following information on a separate line for each laboratory safety level: the select agent or toxin; the type of work with each select agent or toxin
(e.g., viable, genomic material, recombinant DNA, use in animals, or large scale), the building and room number(s) where each select agent or toxin will be used
and stored, and laboratory safety level for each Principal Investigator (or Chief Scientist). For entities only storing and not actively working with select agents or
toxins, do not complete “laboratory area” column. For information on completing this section, refer to page 2 of the guidance document.
Select
agent/Toxin
name

Viable

Genomic
Material

Recombinant
DNA

Animal

Large
Scale

Toxin

Laboratory Area
Bldg

Room

Storage Area
Bldg

Room

Laboratory
Safety Level*

Principal
Investigator

INDICATE WITH AN "X" FOR EACH SELECT AGENT/TOXIN AS APPROPRIATE

*Biosafety Level 2=BSL2
Biosafety Level 3=BSL3
Biosafety Level 4=BSL4

Animal Biosafety Level 2=ABSL2
Animal Biosafety Level 3=ABSL3
Animal Biosafety Level 4=ABSL4

rDNA BSL2=NIHBL2
rDNA BSL3=NIHBL3
rDNA BSL4=NIHBL4

rDNA Large Animal BSL2=NIH BL2N
rDNA Large Animal BSL3=NIH BL3N
rDNA Large Animal BSL4=NIH BL4N

rDNA Large Scale BSL2=NIH BL2-LS
rDNA Large Scale BSL3=NIH BL3-LS
rDNA Large Scale BSL4=NIH BL4-LS

Toxin= 29 CFR 1910.1450, 29 CFR 1910.1200 and BMBL

I certify that the select agents and toxins listed are categorized commensurate with the risk of the select agent or toxin and its intended use, and the biosafety and
containment procedures are sufficient to contain the select agent or toxin.
Responsible Official/Alternate Responsible Official Signature:____________________________________________ Date: _______________

This application is:

A new registration

An amendment to an existing registration

Legal name of entity:

Date
Entity registration number (e.g., A00000000-0000):

SECTION 4B – AUTHORIZED PERSONNEL WORKING WITH SELECT AGENTS AND TOXINS
(TO BE COMPLETED BY ALL RO’S)

Provide the following information for the Responsible Official (RO), Alternate Responsible Official (ARO), owners of the entity, as well as each person who is authorized to have
access to select agents and toxins at the entity. If the person listed is identified to own or control the entity, indicate “Y” in the “Owner/Controller” column. The name (including middle
initial) and the date of birth and address (including zip code) for individuals listed on this table should be identical to that given on the FD-961 Form submitted to CJIS for each
individual. To request additions to or deletions from this list of individuals, submit this page to the agency that you filed your original application (APHIS or CDC). For information on
completing this section, refer to page 3 of the guidance document.

Last Name

First Name

Middle
Initial

Date of
Birth
(mmddyr)

Home
Address
(No P.O. boxes)

Principal Investigator
(PI’s, RO’s, ARO’s, and
owners leave this column
blank)

Select
Agent(s)/Toxin(s)

Laboratory
Building

Laboratory
Room

Job Title

Owner/
Controller
(Y/N)

I certify that information and training on safety and security for working with select agents and toxins has been provided to the individuals listed above who will have access to select
agents and toxins.
Responsible Official/Alternate Responsible Official Signature:____________________________________________ Date: _______________

Principal investigator: _______________________________________________ Date: ________________
Laboratory building: ____________________________ Laboratory room number(s): ________________________ Laboratory safety level:_________________

SECTION 5 – LABORATORY INFORMATION
(COMPLETED BY EACH PRINCIPAL INVESTIGATOR AND APPROVED BY THE RO)

Provide the following information for each principal investigator (PI) working with select agents and toxins at your entity. Make additional copies of this section of
the form as needed. Each principal investigator should complete Section 5 as appropriate for each laboratory room where select agents and toxins are used or
stored. For information on completing this section, refer to page 3 of the guidance document.
SECTION 5A – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
1.

Name of individual responsible for the laboratory (e.g., principal investigator): ____________________________________________

Provide the following information for each select agent(s) and toxin(s) worked with or stored in the laboratory building(s) and room(s):

SELECT
AGENT/TOXIN
NAME

STRAIN
DESIGNATION

DATE
ACQUIRED
(list N/A if not
acquired)

ADDRESS OF FACILITY FROM
WHICH THE SELECT
AGENT/TOXIN WAS
ACQUIRED
(Include registration number if
applicable)

SOURCE
OF ISOLATE

FACILITY
AGENT I.D.
(Include any
identification
used to identify
agent unique to
laboratory)

Clinical

Environmental

UNIQUE
CHARACTERISTICS

Other (explain)

REFERENCE FOR
PUBLISHED
SEQUENCE
INFORMATION
(GenBank accession
number, journal articles, etc.)

SECTION 5B – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
(OBJECTIVES OF WORK)
Make additional copies of this section of the form as needed for each laboratory room for each principal investigator at your
entity. Each principal investigator should complete questions 1 through 101, as appropriate for each laboratory where select
agents are used or stored. If all laboratories with the same biosafety level under the control of one principal investigator meet
the same criteria, then list all laboratory rooms and submit only one form. Include a floor plan for each laboratory where
select agents or toxins are to be used or stored.
1. Provide the objectives of the work for each select agent or toxin listed on Table 4A, including a description of the
methodologies or laboratory procedures that will be used. State if any host-vector systems will be used. Specify whether
work will involve live select agents and recombinant DNA. If no work is being performed on select agent or toxin, indicate
storage only. Attach additional sheets if needed:
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
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, then indicate “no propagation of agent”. Attach additional sheets if needed:
_______________________________________________________________________________________________
3. Additional Principal investigators performing the same objective of work:

Yes

If yes, list: _______________________________________________________________________________________
________________________________________________________________________________________________
SECTION 5C – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
(FACILITY)
Include a floor plan for each laboratory where select agents or toxins are to be used or stored (for all laboratory safety
levels).
4.

Laboratory is currently operational:
If no, date of anticipated completion of laboratory:

Yes

__________________________

Floor plan(s) for all laboratory safety levels include:
a.

Entry into laboratory:

Yes

Sink locations:

Yes

Eyewash locations:

Yes

Biological safety cabinet (BSC) locations:

Yes

Fume hood locations:

Yes

HVAC supply and exhaust locations:

Yes

Freezer/refrigerator locations:

Yes

Other large equipment locations (incubators, centrifuges, etc):

Yes

Autoclave location (if applicable):

Yes

N/A

Incinerator location (if applicable):

Yes

N/A

Cage washing area (if applicable):

Yes

N/A

NOTE: For BSL-4 or ABSL-4 facility questions, complete Section 5P and all other applicable sections.

SECTION 5D – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
WORKING IN BSL2 LABORATORY(IES)
6.

Will work be performed in BSL2 laboratory(ies)?
If yes, complete questions 7 – 8.

Yes

Provide a description of the HVAC system (check all that are appropriate):
Single-pass

Re-circulated

Dedicated exhaust

Shared exhaust

Constant air volume

Variable air volume

Redundant exhaust fans
Emergency power back-up
8.

Provide information on the biological safety cabinets (BSC) in use (For more than one cabinet, provide class and how
BSC is connected to HVAC system. Attach additional sheets if needed):
a.

Class of cabinet #1:

II, Type A1

II, Type A2 (formerly II, B3)

II, B1

II, B2

III

Class of cabinet #2:

II, Type A1

II, Type A2 (formerly II, B3)

II, B1

II, B2

III

BSC #1 connection to the HVAC system:

Hard duct

Thimble

Re-circulating

BSC #2 connection to the HVAC system:

Hard duct

Thimble

Re-circulating

Define certification period:

Annual

Biannual

N/A

Other (explain):________________________________

SECTION 5E – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
WORKING IN BSL3 LABORATORY(IES)
9.

Will work be performed in BSL3 laboratory(ies)?
If yes, complete questions 10 – 20.

Yes

10. Provide a description of the HVAC system (check all that are appropriate):
Single-pass

Re-circulated

Dedicated exhaust

Shared exhaust

Constant air volume

Variable air volume

Redundant exhaust fans
Emergency power back-up
11. Provide information on the biological safety cabinets (BSC) in use (For more than one cabinet, provide class and how
BSC is connected to HVAC system. Attach additional sheets if needed):
a.

Class of cabinet #1:

II, Type A1

II, Type A2 (formerly II, B3)

II, B1

II, B2

III

Class of cabinet #2:

II, Type A1

II, Type A2 (formerly II, B3)

II, B1

II, B2

III

BSC #1 connection to the HVAC system:

Hard duct

Thimble

Re-circulating

BSC #2 connection to the HVAC system:

Hard duct

Thimble

Re-circulating

Define certification period:

Annual

Biannual

N/A

Other (explain):________________________________

12. Entry into the lab is through a double set of lockable self-closing doors:

Yes

13. Each laboratory room has a hands-free sink:

Yes

14. An eyewash station is readily available inside the laboratory:

Yes

15. All cultures, stock and other regulated wastes are decontaminated before removal from the
containment area:
Yes
No
If yes, describe method:
Autoclaved (temperature, time, and psi):________________________________________________________
Chemical (disinfectant, concentration, and time): _________________________________________________
Irradiation: _______________________________________________________________________________
Other:___________________________________________________________________________________

16. Laboratory exhaust is re-circulated to other areas of the facility:

Yes

17. The laboratory is maintained at negative air pressure to provide directional air into the laboratory:

Yes

18. A visual system is provided for laboratory personnel to monitor directional air before entry and
during use of the laboratory:

Yes

19. An alarm system is provided to warn laboratory personnel of exhaust system failure:

Yes

20. HEPA filtration of all exhaust air is in place:

Yes

SECTION 5F – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
WORKING IN ABSL2 LABORATORY(IES)
21. Will work be performed in ABSL2 laboratory(ies)?
If yes, complete questions 22 – 31.

Yes

22. Provide a description of the HVAC system (check all that are appropriate):
Single-pass

Re-circulated

Dedicated exhaust

Shared exhaust

Constant air volume

Variable air volume

Redundant exhaust fans
Emergency power back-up
23. Provide information on the biological safety cabinets (BSC) in use (For more than one cabinet, provide class and how
BSC is connected to HVAC system. Attach additional sheets if needed):
a.

Class of cabinet #1:

II, Type A1

II, Type A2 (formerly II, B3)

II, B1

II, B2

III

Class of cabinet #2:

II, Type A1

II, Type A2 (formerly II, B3)

II, B1

II, B2

III

BSC #1 connection to the HVAC system:

Hard duct

Thimble

Re-circulating

BSC #2 connection to the HVAC system:

Hard duct

Thimble

Re-circulating

Define certification period:

Annual

Biannual

N/A

Other (explain):________________________________

24. Animal laboratories are separated from open and unrestricted areas:

Yes

25. Animal laboratory exhaust is re-circulated to other areas of the facility:

Yes

26. The animal laboratory is maintained at negative air pressure to provide directional air into the
animal laboratory:

Yes

27. External doors are self-closing, self-locking, and open inward:

Yes

28. There is an autoclave in the laboratory:

Yes

29. The location of cage washing area is included on floor plan:

Yes

30. Each animal room where infected animals are kept contains a hand-washing sink:

Yes

31. If floor drains are provided, the traps are always filled with an appropriate disinfectant:

Yes

If yes, cage washing is:

Manual

With a mechanical cage washer

SECTION 5G – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
WORKING IN ABSL3 LABORATORY(IES)
32. Will work be performed in ABSL3 laboratory(ies)?
If yes, complete questions 33 – 46.

Yes

33. Provide a description of the HVAC system (check all that are appropriate):
Single-pass

Re-circulated

Dedicated exhaust

Shared exhaust

Constant air volume

Variable air volume

Redundant exhaust fans
Emergency power back-up
34. Provide information on the biological safety cabinets (BSC) in use (For more than one cabinet, provide class and how
BSC is connected to HVAC system. Attach additional sheets if needed):
a.

Class of cabinet #1:

II, Type A1

II, Type A2 (formerly II, B3)

II, B1

II, B2

III

Class of cabinet #2:

II, Type A1

II, Type A2 (formerly II, B3)

II, B1

II, B2

III

BSC #1 connection to the HVAC system:

Hard duct

Thimble

Re-circulating

BSC #2 connection to the HVAC system:

Hard duct

Thimble

Re-circulating

Define certification period:

Annual

Biannual

N/A

Other (explain):________________________________

35. Animal laboratories are separated from open and unrestricted areas:

Yes

36. Entry into the animal lab is through a double set of lockable self-closing doors:

Yes

37. External doors are self-closing, self-locking, and open inward:

Yes

38. Each animal room contains a hands-free hand washing sink:

Yes

39. Animal laboratory exhaust is re-circulated to other areas of the entity:

Yes

40. The animal laboratory is maintained at negative air pressure to provide directional air into the
animal laboratory:

Yes

41. A visual system is provided for laboratory personnel to monitor directional air before entry and
during use of the animal laboratory:

Yes

42. An alarm system is provided to warn laboratory personnel of exhaust system failure:

Yes

43. HEPA filtration of all exhaust air is present:

Yes

44. There is an autoclave in the laboratory:

Yes

45. The location of cage washing area is included on floor plan:

Yes

If yes, cage washing is:

Manual

With a mechanical cage washer

46. If floor drains are provided, the traps are always filled with an appropriate disinfectant:

SECTION 5H – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
(SECURITY)
47. Each laboratory has a site-specific written security plan:

Yes

Plan designed according to a site-specific risk assessment and provides graded protection
in accordance with the risk of select agent or toxin:

Yes

Plan contains all information as required by the Select Agent Regulations:

Yes

The plan is reviewed annually and revised as necessary:

Yes

Drills or exercises are conducted to validate or test the effectiveness of the plan:

Yes

48. Physical Security (check all apply):
a.

Means to limit access to buildings with select agents and toxins:
Guard station at the building entrance
Locks
Card access system
Biometric system
Intrusion detection system
Other (describe): ________________________________________________________________________

Means to limit access to rooms with select agents and toxins:
Locks
Card access system
Biometric system
Intrusion detection system
Other (describe): ________________________________________________________________________

Means to limit access to select agents and toxins inside the room:
Locked incubators, refrigerators, freezers, etc.
Locked box inside incubators, refrigerators, freezers, etc.
Biometric system
Card access system
Intrusion detection system
Other (describe): ________________________________________________________________________

Means to monitor access to areas where select agents and toxins are used or stored:
Electronic logs of access
Manual sign in logs
Video camera surveillance
Other (describe): ________________________________________________________________________

Access to select agents and toxins is restricted to individuals that have access approval from the
APHIS Administrator or HHS Secretary:

Yes

Are individuals not approved for access from the APHIS Administrator or HHS Secretary allowed
access to an area with select agents and toxins?

Yes

1) If yes, are these individuals allowed into the area escorted?

Yes

2) If no, explain: ___________________________________________________________________________
g.

Yes

49. Suspicious packages are inspected prior to entry or removal from an area where select agents and
toxins are used or stored:

Yes

50. Select agents and toxins are transferred within the entity (intra-entity transfers):

Yes

Intra-entity transfer is only under the supervision of an individual with access approval from
APHIS Administrator or HHS Secretary:

Yes

Chain-of-custody documents are used for intra-entity transfers:

Yes

The laboratory is secured when no one is present during regular working hours:

51. Select agents and toxins are transferred from a laboratory to a shipping area and vice versa only under
the supervision of an individual with access approval from APHIS Administrator or HHS Secretary:

SECTION 5I – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
(BIOSAFETY AND INCIDENT RESPONSE)
52. Each laboratory has a written agent-specific, site-specific biosafety plan:

Yes

The plan is commensurate with the risk of the select agent and toxin and contains all
information as required by the Select Agent Regulations:

Yes

The plan is reviewed annually and revised as necessary:

Yes

Drills or exercises are conducted to validate or test the effectiveness of the plan:

Yes

53. Appropriate personal protective equipment (PPE) is used:

Yes

N/A

54. A medical surveillance system is in place for personnel using the select agents and toxins:

Yes

N/A

55. Spills and accidents that result in overt or potential exposures to infectious materials are immediately
reported:

Yes

56. A sharps policy is in place for this laboratory:

Yes

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

Yes

If yes, has the IBC approved the work proposed in this application:
58. The facility has been inspected by USDA, FDA, CLIA, DoE, DoD or others:

If yes, then give agency name and date of last inspection(s): _____________________________________________
59. Each laboratory has a written incident response plan:

Yes

The plan is commensurate with the hazards of the select agent and toxin and contains
all information as required by the Select Agent Regulations:

Yes

The plan is reviewed annually and revised as necessary:

Yes

Drills or exercises are conducted to validate or test the effectiveness of the plan:

Yes

SECTION 5J – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
(TRAINING)
60. Training:
a. Security and biosafety training is provided prior to individual’s access to areas where select agents
and toxins are handled or stored:

Yes

b. Training addresses the needs of the individual, the work being performed, and risks posed by
select agents and toxins:

Yes

c. Refresher training is provided:

Annually

Biannually

Other (specify frequency): __________________

d. Written records of individuals trained are kept:

Yes

e. Personnel demonstrate proficiency in laboratory procedures prior to working with
select agents and toxins:

Yes

f. Provide a brief description of what is included in the training program:
Biosafety: ______________________________________________________________________________
Incident Response: _______________________________________________________________________
Security: _______________________________________________________________________________
Other: _________________________________________________________________________________
g. Describe the means used to verify that individuals understood the training (add additional sheets as necessary):
__________________________________________________________________________________________
__________________________________________________________________________________________

SECTION 5K – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
(RECORDS AND INFORMATION SYSTEMS CONTROL)
61. Complete records are maintained as required by the Select Agent Regulations:

Yes

62. Provide a brief explanation of the system in place that ensures records and databases are accurate, their
authenticity may be verified, and explains any discrepancies:
__________________________________________________________________________________________
__________________________________________________________________________________________
63. Describe the means to control access to records and databases that would allow for access to select agents and toxins:
Locks
Locked filing cabinet, drawer, cabinet, etc.
Secured electronic database (e.g., password protected, “stand alone PC”)
Card access system
Other: __________________________________________________________________________________
a.

Are these records and databases located on any computer on a network?

Yes

If yes, provide a brief explanation of the systems in place to prevent unauthorized access to select agents and
toxins (e.g., password protected, firewall protection)? _______________________________________________
__________________________________________________________________________________________
64. Name(s) of Individual(s) responsible for inventory of select agent(s) and toxin(s): _____________________________
a.

Inventory record is reconciled:

Annually

Biannually

Inventory tracking includes the following information (list):

Other (specify frequency): _________________
__________________________________________

__________________________________________________________________________________________
__________________________________________________________________________________________

SECTION 5L – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
WORKING WITH TOXINS
65. Will work be performed with toxins or with agents that produce regulated amounts of toxins?
If yes, complete questions 66 – 71.

Yes

66. A Chemical Hygiene Plan is available for the laboratory using toxins:

Yes

67. Maximum quantity of each toxin under the control of the principal investigator, treating physician or veterinarian, or
commercial manufacturer or distributor, at a given time:
a.

Toxin: ________________________

Aggregate amount of Toxin: __________________________

Toxin: ________________________

Aggregate amount of Toxin: __________________________

Toxin: ________________________

Aggregate amount of Toxin: __________________________

68. Form of toxins used:

Liquid

Lyophilized

Not Applicable-Storage Only

69. The toxin is produced by viable agent at the entity:
a.

Yes

If yes, provide a brief description of procedures used (include an estimate of the maximum quantities grown at a
given time): ________________________________________________________________________________

70. Dilution procedures and other manipulations of the concentrated toxins are performed:
Fume hood

Yes

If yes, conducted in:

Biological safety cabinet

If a fume hood or biosafety cabinet is used, certification is conducted:
Annually
Biannually
Other (describe): _____________________________________________

Work is conducted with two knowledgeable people present:

71. A hazard sign is posted on the door when toxins are in use:

Yes

SECTION 5M – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
WORKING WITH GENETIC ELEMENTS, RECOMBINANT NUCLEIC ACIDS, OR RECOMBINANT ORGANISMS
72. Will work be performed with genetic elements,
recombinant nucleic acids,
or recombinant organisms?

Yes
Yes
Yes

No
No
No

Yes

If yes, complete questions 73 – 77.
73. The biosafety level listed in Section 4A for this laboratory meets NIH guidelines:
74. Will you be possessing, using or transferring the following:
a.

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

Recombinant nucleic acids that encode for the functional form(s) of any select toxins if the nucleic acids:

1) can be expressed in vivo or in vitro.

Yes

2) are in a vector or recombinant host genome and can be expressed in vivo or in vitro.

Yes

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

Yes

75. Provide a brief description of the recombinant constructs and any associated expression control elements, including
what the recombinant DNA encodes for, if known: _____________________________________________________
76. Give an estimate of range of length of recombinant DNA to be used: _______________________________________
77. Are you intending to conduct the following restricted experiments as defined under 7 CFR 331.13, 9 CFR 121.13,
and 42 CFR 73.13?
Yes
a.

Experiments utilizing recombinant DNA that involve the deliberate transfer of a drug resistance trait to select agents
that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control
disease agents in humans, veterinary medicine, or agriculture:
Yes
No
If yes, provide a brief description of the restricted experiment: _________________________________________
___________________________________________________________________________________________

Experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of select
toxins lethal for vertebrates at an LD50 < 100 ng/kg body weight:
Yes
No
If yes, provide a brief description of the restricted experiment: _________________________________________
___________________________________________________________________________________________

Note: An individual or entity may not conduct a restricted experiment with select agents and toxins unless approved by
the APHIS Administrator and HHS Secretary.
SECTION 5N – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
WORKING WITH ANIMALS
78. Will work be performed with animals?
If yes, complete questions 79 – 84.

Yes

79. List species of animals that will be used: ______________________________________________________________
80. Describe route of administration of select agent or toxin:__________________________________________________
81. Animal waste is treated prior to disposal (e.g., carcasses, sewage, bedding, etc.) by an approved method:
Not treated
Autoclaved (temperature, time, and psi):__________________________________________________________
Chemical (disinfectant, concentration, and time): ___________________________________________________
Irradiation: _________________________________________________________________________________
Other:_____________________________________________________________________________________
82. Carcasses of animals are disposed of on site:

Yes

a. If yes, provide method of disposal of treated carcasses:
Incineration

Rendering

Chemical decomposition

Other (describe): _______________________________

b. If no, describe:________________________________________________________________________________

83. The entity requires that an Institutional Animal Care and Use Committee (IACUC) review and approve
protocols prior to work with animals at this entity:
If yes, the proposed work with select agents and toxins in animals has been approved by the IACUC:

Yes

84. The laboratory is accredited by the Association for Assessment and Accreditation of Laboratory
Animal Care (AAALAC):
If yes, give accreditation date: ___________________
SECTION 5O – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
WORKING WITH PLANTS
85. Will work be performed with plants?
If yes, complete questions 86 – 93.

Yes

86. Work will be done in a glass or greenhouse:

Yes

If yes, provide a description of the glass or greenhouse:
Laminated Glass

Tempered Glass

Lexan

Other (describe): _________________________________

87. Structure is reinforced:

Yes

88. Floor is concrete:

Yes

89. Vents in facility:

Yes

90. Waste water collection and treatment:

Yes

91. Greenhouse HVAC supply and exhaust:
a.

Negative air pressure is maintained inside greenhouse:

Yes

Greenhouse exhaust is re-circulated to other areas of the facility:

Yes

Yes
Yes

No
No

If yes, HEPA filtration of all exhaust air is in place:
c.

Provide a description of the HVAC system (check all that are appropriate):
Single-pass

Re-circulated

Dedicated exhaust

Shared exhaust

Constant air volume

Variable air volume

Redundant exhaust fans
Emergency power back-up
92. Vectors present:
If yes, vectors are restricted to cages:

93. Plant waste is treated prior to disposal (e.g., soil, plant material, etc.) by an approved method:
Not treated
Autoclaved (temperature, time, and psi):__________________________________________________________
Chemical (disinfectant, concentration, and time): ___________________________________________________
Irradiation: _________________________________________________________________________________
Other:_____________________________________________________________________________________

SECTION 5P – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR
WORKING IN BSL4/ABSL4 LABORATORIES
94. Will work be performed in BSL4/ABSL4 Laboratory?
a. If yes, complete questions 95 – 101.

Yes

b. Activities conducted under BSL-4/ABSL4 laboratory (check all that apply):
Research
Small animal
Diagnostic
Large animal
Large scale production
Recombinant DNA
Other (give description):____________________________________________________________________
95. What type of BSL-4 laboratories are you registering?
Stand alone Class III cabinet laboratory (complete question 99)
Protective suit laboratory (complete question 100)
Protective suit laboratory with associated Class III cabinet (complete questions 99 and 100)
ABSL-4 Stand alone Class III cabinet laboratory (complete questions 99 and 101)
ABSL-4 Protective suit laboratory (complete questions 100 and 101)
ABSL-4 Protective suit laboratory with associated Class III cabinet (complete all questions)

96. Provide a description of the HVAC system (check all that are appropriate):
Single-pass

Re-circulated

Dedicated exhaust

Shared exhaust

Constant air volume

Variable air volume

Redundant exhaust fans
Emergency power back-up
97. Provide information on the biological safety cabinets (BSC) in use (For more than one cabinet, provide class and how
BSC is connected to HVAC system. Attach additional sheets if needed):
a.

Class of cabinet #1:

II, Type A1

II, Type A2 (formerly II, B3)

II, B1

II, B2

III

Class of cabinet #2:

II, Type A1

II, Type A2 (formerly II, B3)

II, B1

II, B2

III

BSC #1 connection to the HVAC system:

Hard duct

Thimble

Re-circulating

BSC #2 connection to the HVAC system:

Hard duct

Thimble

Re-circulating

Define certification period:

Annual

Biannual

N/A

Other (explain):________________________________

98. Provide safety information for the BSL-4 laboratory facility(ies) you are registering by answering the questions in this
section. Use separate sheets if necessary.

A specific BSL-4 facility operations manual has been prepared:

Yes

All standard BSL-4 microbiological practices are followed:

Yes

There is a mandatory daily inspection of the containment parameters for the BSL-4 laboratory area(s) and critical
life support systems:
Yes
No

Walls, floors, and ceilings of the BSL-4 laboratory rooms are sealed. All penetrations into the laboratory are
sealed:
Yes

A visual pressure differential monitoring system is provided at the clean change room for laboratory personnel to
verify directional air before entry into the BSL-4 laboratory:
Yes
No

Differential pressures/directional airflow between adjacent areas is monitored and alarmed (visually and audibly) to
indicate system failure:
Yes
No

Double HEPA filtration of all suit area, decontamination shower, decontamination airlock and Class III cabinet
exhaust air is in place:
Yes
No

Single HEPA filtration of all suit area, decontamination shower, decontamination airlock and Class III cabinet supply
air is in place:
Yes
No

Describe method utilized for decontamination of BSL-4 area(s):
__________________________________________________________________________________________
__________________________________________________________________________________________

99. Entities registering a stand alone Class III cabinet laboratory must complete the following information:
a. Inner and outer change rooms are separated by a shower for personnel entering and leaving the cabinet room:
Yes
No
b. There is a double-door (pass-through) autoclave, dunk tank, fumigation chamber, or ventilated anteroom for
passing materials, supplies, or equipment into or out of the cabinet room:
Yes

c. Walls, floors, and ceilings of the cabinet room(s) are sealed and all penetrations into the cabinet room(s) are
sealed:
Yes

d. Floors are seamless and coved:

Yes

e. All drains in the cabinet room(s), inner change room(s), and autoclave chambers connect directly to an appropriate
liquid waste decontamination system:
Yes
No
f.

Sewer vents and other service lines contain HEPA filters:

Yes

g. Bench tops are seamless or sealed surfaces that are impervious to water and resistant to moderate heat and
organic solvents, acids, alkalis, and other decontaminant chemicals:
Yes
No
h. Laboratory furniture is capable of supporting anticipated loads and uses and is covered with a non-fabric material
that can be easily decontaminated:
Yes
No
i.

If a central vacuum system is present, it serves only the cabinet room(s) and is HEPA filter protected, and liquid and
gas services to the cabinet room are protected by backflow prevention devices:
Yes
No

Any windows are break resistant and sealed:

Yes

k. Double-door autoclaves are provided for decontamination of materials removed from the Class III cabinet and the
cabinet room. These autoclaves are interlocked so that the outside door can only be opened after the sterilization
cycle is complete:
Yes
No
l.

Pass-through dunk tanks, fumigation chambers, or equivalent decontamination methods are provided so that
materials and equipment that cannot be decontaminated in the autoclave can be safely removed from both the
Class III biological safety cabinet(s) and the cabinet room(s):
Yes
No

m. All HEPA filters are tested and certified annually:

Yes

n. An HVAC monitoring system is provided to avoid pressurization of the laboratory and is alarmed to warn
laboratorians of exhaust system failure:
Yes

o. There is HEPA filtration of all supply and exhaust air from the cabinet room(s), inner change room(s), and
anteroom(s):
Yes

p. The Class III cabinet is directly connected to the exhaust system with HEPA filtration on the supply and double
HEPA filtration on the exhaust:
Yes
No
q. Appropriate communication systems are provided between the laboratory and external personnel (intercom, phone,
fax, and computer):
Yes
No

100. Entities registering a protective suit laboratory must complete the following information:

Entry into the area(s) where work is performed with BSL-4 select agents [suit room(s)] is through a series of
changing and decontamination areas separated by airtight doors:
Yes
No

Inner and outer change rooms are separated by a personal shower:

Yes

A chemical shower is provided for decontaminating the outer surface of the protective suit:

Yes

A breathing air system is provided with redundant compressors, backup storage tanks, HEPA filtration protection,
and alarm monitoring in the event of failure:
Yes
No

All penetrations into containment shell (walls, floors, and ceilings) of the suit area(s), chemical shower(s), and
airlock(s) are sealed:
Yes
No

Daily inspections of the containment parameters and life support systems are performed, completed and
documented before laboratory work begins:
Yes
No

A double-door, interlocked autoclave is provided for decontaminating waste materials removed from the suit
area(s):
Yes
No

A dunk tank, fumigation chamber, or ventilated airlock to pass materials, supplies, or equipment into or out of the
suit area(s):
Yes
No

Bench tops are seamless surfaces that are impervious to water and resistant to moderate heat and organic
solvents, acids, alkalis, and other decontaminant chemicals:
Yes
No

Laboratory furniture is capable of supporting anticipated loads and uses and is covered with a non-fabric material
that can be easily decontaminated:
Yes
No

If a central vacuum system is present, it serves only the suit area(s) and is protected by HEPA
filtration:

Yes

Liquid and gas services to the suit area(s) are protected by backflow devices:

Yes

m. Inner and outer doors to chemical showers and airlocks are interlocked to prevent both doors from being opened at
the same time:
Yes
No
n.

Any windows are break resistant and sealed:

Yes

All drains in the suit area(s), chemical shower(s), and autoclave chambers connect directly to an appropriate liquid
waste decontamination system:
Yes
No

An HVAC monitoring system is provided to avoid pressurization of the laboratory and is alarmed to warn
laboratorians in the event of exhaust system failure:
Yes
No

Redundant exhaust fans are installed:

Yes

All HEPA filters are tested and certified annually:

Yes

HVAC supply to the suit area(s), chemical shower(s), and airlock(s) is HEPA filtered:

Yes

HVAC exhaust from the suit area(s), chemical shower(s), and airlock(s) is double HEPA filtered with the HEPA
No
filters in series:
Yes

Appropriate communication systems are provided between the laboratory and external personnel (intercom, phone,
fax, and computer):
Yes
No

Emergency lighting and emergency communications systems are provided for the BSL-4 areas:

Yes

101. Entities registering an ABSL-4 laboratory must complete the following information:
a.

Specific procedures have been developed for handling animals under ABSL-4 conditions in the Class III cabinet or
protective suit laboratories being registered:
Yes
No

Aerosol experiments are conducted in this ABSL-4 laboratory:

Describe how animals are housed under ABSL-4 conditions (add additional sheets as necessary):

Yes

__________________________________________________________________________________________
__________________________________________________________________________________________
d.

Personnel assigned to work with infected animals work in pairs:

Yes

Public reporting burden: Public reporting burden of this collection of information for the requirements of this application request is estimated to be 3.75 hours.
An agency may not conduct, nor is an individual required to respond to, information collection unless a current valid OMB control number has been issued. Send
comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR
Reports Clearance Officer; 1600 Clifton Road NE, ATTN: PRA (0920-0576), MS D-74, Atlanta, Georgia 30333.
Penalties: Knowingly providing false statements on any part of this form or its attachments will subject the offender to fines of up to $250,000 ($500,000 for
organizations), imprisonment for up to 5 years or both (18 USC Section 1001). Failure to maintain records constitutes a 1 year misdemeanor (42 USC Section
271).
APHIS/CDC FORM 1 (12/31/2008)

File Type	application/pdf
File Title	FORM APPROVED
Author	tdg9
File Modified	2006-07-10
File Created	2006-02-24