Guidance Document for the completion of APHIS/CDC Form 1

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

Att5a-Form1Guide

Application for Registration (APHIS/CDC Form 1) - Guidance

OMB: 0920-0576

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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 12/31/2018

The APHIS/CDC Form 1, Application for Registration for Possession, Use, and Transfer of Select
Agents and Toxins, is provided as individual Sections to assist entities in data input and revisions as
necessary. Please enter information into the following sections and attachments, according to your
entity’s characteristics.
The APHIS/CDC Form 1, Application for Registration, provides a method for entities to register to
possess, use, or transfer select agents and toxins (as described in 7 CFR 331, 9 CFR 121, and 42
CFR 73). 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(s) who will have access
to select agents and toxins; characterization of the select agents and toxins and additional laboratory
information. Submissions using expired forms or tables will not be accepted. The current, approved
form can be downloaded from http://www.selectagents.gov/form1.html.
If you are completing the APHIS/CDC Form 1 for the first time or as part of your registration renewal,
use this document for assistance in completing the APHIS/CDC Form 1 and submitting it to the
Federal Select Agent Program (FSAP), either the Animal and Plant Health Inspection Service, Select
Agent Program or Centers for Disease Control and Prevention, Division of Select Agents and Toxins.
Entities may also use this form to amend their registration. To apply for an amendment to a certificate
of registration, an entity must submit relevant portion(s) of the APHIS/CDC Form 1 as described in the
amendments section of this document to the FSAP.

According 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 numbers for these information collections are 0579-0213 for APHIS and 0920-0576 for CDC. The time
required to complete the information collection for APHIS ranges from 12 to 19.5 hours per response, and 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.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Instructions for Completion of APHIS/CDC Form 1
OMB NO. 0579-0213 / 0920-0576
EXP DATE 11/30/2015
Prior to completing APHIS/CDC Form 1 ensure that you are using the current, OMB approved form
and/or optional tables. Submissions using expired forms or tables will not be accepted. The current,
approved form and optional tables can be downloaded from http://www.selectagents.gov/form1.html.
If you are completing the APHIS/CDC Form 1 for the first time, please review application instructions
before completing and submitting your application for registration to APHIS or CDC.
If you are a registered entity and are submitting an amendment to your registration, review the
Amendment Requirements section of this document to determine the submission requirements for the
particular type(s) of amendment(s) you are requesting.
Overview
This form is organized in seven (7) sections. Sections 1 – 5 capture entity wide information, Section 6
captures information specific to each suite/room and Section 7 captures information about the work
each PI will perform. Multiple Section 6s may be required if the entity has multiple suites/rooms, and
multiple Section 7s may be required if the entity has multiple PIs. The structure of this form is
designed to facilitate submittal of amendments.
Section 1 requests information about the entity and the Responsible Official (RO), Alternate
Responsible Official (ARO), and Owner/Controller (if applicable). Information for the RO, ARO, and
Owner/Controller (if applicable) is only captured in Section 1.
Section 2 is the RO certification statement.
Section 3 is a list of all select agents, toxins, and regulated nucleic acids for which the entity wishes
to register.
Section 4 lists the individuals who will have access to select agents, toxins, and regulated nucleic
acids at the entity. Information for RO/ARO, Owner/Controller (if applicable), and Principal Investigator
(PI) is captured in Sections 1A and 7A, respectively.
Section 5 captures entity wide information on security, incident response, biosafety, and entry
requirements for inspections.
Section 6 will be completed for each suite/room. Multiples suites or rooms may be included in this
section only if all information captured here is the same for each suite/room listed.
Section 7 will be completed for each PI. Multiple PIs may be included in this section only if they
conduct identical work with select agents or toxins. Attachments A through G (toxin,
recombinant/synthetic DNA, animal, plant, arthropod, BSL3Ag, BSL4) may need to be completed
based on the type of work being performed.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

TABLE OF CONTENTS

Application Instructions
SECTION 1A - ENTITY AND CONTACT INFORMATION ................................................................................... 12
THIS SUBMISSION IS ............................................................................................................................................ 12
DATE .................................................................................................................................................................. 12
ENTITY APPLICATION NUMBER ............................................................................................................................. 12
CURRENT REGISTRATION NUMBER ....................................................................................................................... 12
ENTITY NAME ...................................................................................................................................................... 12
PHYSICAL ADDRESS ............................................................................................................................................ 12
ADDITIONAL PHYSICAL ADDRESS(ES) ................................................................................................................... 13
TYPE OF ENTITY .................................................................................................................................................. 13
RESPONSIBLE OFFICIAL INFORMATION.................................................................................................................. 14
RO NAME (LAST AND FIRST NAME)....................................................................................................................... 14
RO DOJ NUMBER ............................................................................................................................................... 14
RO DATE OF BIRTH ............................................................................................................................................. 14
RO BUSINESS EMAIL ADDRESS............................................................................................................................ 14
RO TITLE ............................................................................................................................................................ 14
RO TIER 1 ACCESS ............................................................................................................................................. 14
RO BUSINESS TELEPHONE NUMBER .................................................................................................................... 15
RO BUSINESS FAX NUMBER ................................................................................................................................ 15
RO EMERGENCY TELEPHONE NUMBER ................................................................................................................ 15
RO MAILING ADDRESS ........................................................................................................................................ 15
ALTERNATE RESPONSIBLE OFFICIAL INFORMATION ............................................................................................... 15
ARO NAME (LAST AND FIRST NAME) .................................................................................................................... 15
ARO DOJ NUMBER............................................................................................................................................. 16
ARO DATE OF BIRTH........................................................................................................................................... 16
ARO’S BUSINESS EMAIL ADDRESS ...................................................................................................................... 16
ARO TITLE ......................................................................................................................................................... 16
ARO TIER 1 ACCESS........................................................................................................................................... 16
ARO BUSINESS TELEPHONE NUMBER .................................................................................................................. 16
ARO BUSINESS FAX NUMBER .............................................................................................................................. 16
ARO EMERGENCY TELEPHONE NUMBER .............................................................................................................. 16
ARO MAILING ADDRESS ...................................................................................................................................... 17
OWNER/CONTROLLER INFORMATION .................................................................................................................... 17
OWNER/CONTROLLER NAME (LAST AND FIRST NAME) ........................................................................................... 17
OWNER/CONTROLLER DOJ NUMBER ................................................................................................................... 17
OWNER/CONTROLLER DATE OF BIRTH ................................................................................................................. 17
OWNER/CONTROLLER TIER 1 ACCESS ................................................................................................................. 17
SECTION 1B - CERTIFICATE OF RESPONSIBILITY ........................................................................................ 18
RO/ARO SIGNATURES ........................................................................................................................................ 18
SECTION 1C - ENTITY ABSTRACT .................................................................................................................... 19
•HEADER INFORMATION ....................................................................................................................................... 19
THIS SUBMISSION IS ............................................................................................................................................ 19
ENTITY NAME ...................................................................................................................................................... 19
DATE .................................................................................................................................................................. 19
ENTITY ABSTRACT ............................................................................................................................................... 19
SECTION 2 - RO CERTIFICATION OF PERSONNEL AND FACILITY ACTIVITIES ......................................... 20
HEADER INFORMATION ........................................................................................................................................ 20

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

THIS SUBMISSION IS ............................................................................................................................................ 20
ENTITY NAME ...................................................................................................................................................... 20
DATE .................................................................................................................................................................. 20
RO SIGNATURE................................................................................................................................................... 20
SECTION 3 - SELECT AGENTS AND TOXINS................................................................................................... 23
HEADER INFORMATION ........................................................................................................................................ 23
ENTITY NAME ...................................................................................................................................................... 23
DATE .................................................................................................................................................................. 23
CHECK IF SELECT AGENT/TOXIN POSSESSED ....................................................................................................... 26
EXAMPLES FOR COMPLETING THE SECTION 3 TABLE ............................................................................................. 26
SECTION 4A - LABORATORIANS AND ANIMAL CARE STAFF ...................................................................... 27
HEADER INFORMATION ........................................................................................................................................ 27
THIS SUBMISSION IS ............................................................................................................................................ 27
ENTITY NAME ...................................................................................................................................................... 27
DATE .................................................................................................................................................................. 27
TIER 1 ACCESS ................................................................................................................................................... 27
NAME (LAST AND FIRST NAME) ............................................................................................................................. 28
DOJ NUMBER ..................................................................................................................................................... 28
DATE OF BIRTH ................................................................................................................................................... 28
ROLE .................................................................................................................................................................. 28
SUPERVISING PRINCIPAL INVESTIGATOR (PI) ........................................................................................................ 28
RO/ARO SIGNATURE .......................................................................................................................................... 28
SECTION 4B - SUPPORT STAFF........................................................................................................................ 30
HEADER INFORMATION ........................................................................................................................................ 30
THIS SUBMISSION IS ............................................................................................................................................ 30
ENTITY NAME ...................................................................................................................................................... 30
DATE .................................................................................................................................................................. 30
TIER 1 ACCESS ................................................................................................................................................... 30
NAME ................................................................................................................................................................. 30
DOJ NUMBER ..................................................................................................................................................... 31
DATE OF BIRTH ................................................................................................................................................... 31
ROLE .................................................................................................................................................................. 31
RO/ARO SIGNATURE .......................................................................................................................................... 31
SECTION 4C - UNESCORTED VISITORS .......................................................................................................... 32
HEADER INFORMATION ........................................................................................................................................ 32
THIS SUBMISSION IS ............................................................................................................................................ 32
ENTITY NAME ...................................................................................................................................................... 32
DATE .................................................................................................................................................................. 32
TIER 1 ACCESS ................................................................................................................................................... 32
NAME ................................................................................................................................................................. 33
HOME ENTITY DOJ UNIQUE IDENTIFIER NUMBER .................................................................................................. 33
UNESCORTED VISITOR DATE OF BIRTH ................................................................................................................. 33
UNESCORTED VISITOR SUPERVISING PRINCIPAL INVESTIGATOR ............................................................................ 33
RO/ARO SIGNATURE .......................................................................................................................................... 33
EXAMPLES FOR COMPLETING THE SECTION 4 TABLES ........................................................................................... 34
SECTION 5A - ENTITY-WIDE SECURITY ASSESSMENT AND INCIDENT RESPONSE ................................. 36
HEADER INFORMATION ........................................................................................................................................ 36
THIS SUBMISSION IS ............................................................................................................................................ 36
ENTITY NAME ...................................................................................................................................................... 36
DATE .................................................................................................................................................................. 36
QUESTION 1, FACILITY TYPE (CHECK ALL THAT APPLY) .......................................................................................... 36

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

QUESTION 2, SECURITY OFFICER ......................................................................................................................... 36
QUESTION 3, THREAT ASSESSMENT ..................................................................................................................... 36
QUESTION 4, INSIDER RISK ASSESSMENT .............................................................................................................. 37
QUESTION 5, NATURAL HAZARDS ......................................................................................................................... 37
QUESTION 6, ELECTRONIC RECORDS AND DATABASES .......................................................................................... 37
QUESTION 7, SHIPPING/RECEIVING ...................................................................................................................... 37
QUESTION 8, TRANSPORT.................................................................................................................................... 38
QUESTION 9, RESPONSE TIME ............................................................................................................................. 38
QUESTION 10, AFTER HOURS W ORK.................................................................................................................... 38
SECTION 5B - ENTITY-WIDE BIOSAFETY/BIOCONTAINMENT ...................................................................... 40
HEADER INFORMATION ........................................................................................................................................ 40
THIS SUBMISSION IS ............................................................................................................................................ 40
ENTITY NAME ...................................................................................................................................................... 40
DATE .................................................................................................................................................................. 40
QUESTION 1, BIOSAFETY PROGRAM ..................................................................................................................... 40
QUESTION 2, PROFICIENCY .................................................................................................................................. 40
QUESTION 3, PERSONAL PROTECTIVE EQUIPMENT ............................................................................................... 41
QUESTION 4, OCCUPATIONAL HEALTH (TIER 1) ..................................................................................................... 41
QUESTION 5, OCCUPATIONAL HEALTH (NON-TIER 1)............................................................................................. 41
QUESTION 6, SHARPS.......................................................................................................................................... 41
QUESTION 7, SPILL PROTOCOL ............................................................................................................................ 41
QUESTION 8, PEST MANAGEMENT ........................................................................................................................ 42
SECTION 5C - ENTRY REQUIREMENTS FOR FEDERAL SELECT AGENT PROGRAM INSPECTORS ....... 43
HEADER INFORMATION ........................................................................................................................................ 43
THIS SUBMISSION IS ............................................................................................................................................ 43
ENTITY NAME ...................................................................................................................................................... 43
DATE .................................................................................................................................................................. 43
QUESTION 1, ENTRY TO THE FACILITY .................................................................................................................. 43
QUESTION 2, IDENTIFICATION ............................................................................................................................... 43
QUESTION 3, SECURITY ....................................................................................................................................... 43
QUESTION 4, RESPIRATOR................................................................................................................................... 44
QUESTION 5, PERSONAL PROTECTIVE EQUIPMENT (PPE) ..................................................................................... 44
QUESTION 6, MEDICAL DOCUMENTATION.............................................................................................................. 44
QUESTION 7, ENTITY-SPECIFIC TRAINING .............................................................................................................. 44
QUESTION 8, ADDITIONAL ENTRY REQUIREMENTS ................................................................................................. 44
SECTION 6A - BUILDING AND SUITE/ROOM SPECIFIC SECURITY .............................................................. 45
HEADER INFORMATION ........................................................................................................................................ 45
THIS SUBMISSION IS ............................................................................................................................................ 45
ENTITY NAME ...................................................................................................................................................... 45
DATE .................................................................................................................................................................. 45
BUILDING/SUITE OR ROOM:.................................................................................................................................. 45
QUESTION 1, TIER 1 USE ..................................................................................................................................... 45
QUESTION 2, PERIMETER SECURITY MEASURES ................................................................................................... 46
QUESTION 3, BUILDING ACCESS........................................................................................................................... 46
QUESTION 4, INTERIOR SECURITY MEASURES ...................................................................................................... 46
QUESTION 5, ACCESS TO SUITE/ROOM ................................................................................................................. 46
QUESTION 6, ACCESS TO STORAGE UNITS ........................................................................................................... 46
QUESTION 7, PASS-THROUGH AUTOCLAVE........................................................................................................... 46
QUESTION 8, AUTOCLAVE OUTSIDE OF SUITE/ROOM ............................................................................................ 47
QUESTION 9, PASS-THROUGH W INDOW OR BOX................................................................................................... 47
QUESTION 10, DUNK TANK .................................................................................................................................. 47
SECTION 6B - SUITE/ROOM PHYSICAL INFORMATION ................................................................................. 48
HEADER INFORMATION ........................................................................................................................................ 48

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

THIS SUBMISSION IS ............................................................................................................................................ 48
ENTITY NAME ...................................................................................................................................................... 48
DATE .................................................................................................................................................................. 48
BUILDING/SUITE OR ROOM................................................................................................................................... 48
FLOOR PLANS ..................................................................................................................................................... 48
QUESTION 1, BIOLOGICAL SAFETY LEVEL ............................................................................................................. 49
QUESTION 2, BSC AND FUME HOOD .................................................................................................................... 50
QUESTION 3, SINK ............................................................................................................................................... 50
QUESTION 4, EYEWASH ....................................................................................................................................... 50
QUESTION 5, LIQUID EFFLUENT............................................................................................................................ 50
QUESTION 6, ACCESS DOORS .............................................................................................................................. 51
QUESTION 7, DIRECTIONAL AIRFLOW .................................................................................................................... 51
QUESTION 8, NO REVERSAL OF AIRFLOW ............................................................................................................. 51
QUESTION 9, VERIFICATION ................................................................................................................................. 51
QUESTION 10, MONITORING................................................................................................................................. 51
QUESTION 11, EXHAUST ...................................................................................................................................... 51
QUESTION 12, HEPA FILTERING .......................................................................................................................... 51
QUESTION 13, EMERGENCY SHOWER .................................................................................................................. 52
QUESTION 14, FLOOR DRAINS ............................................................................................................................. 52
QUESTION 15, SINK TRAPS AND FLOOR DRAINS ................................................................................................... 52
QUESTION 16, MECHANICAL CAGE W ASHER......................................................................................................... 52
QUESTION 17, SHOWER OUT ............................................................................................................................... 52
SECTION 7A - PRINCIPAL INVESTIGATOR INFORMATION AND SELECT AGENT AND TOXIN
LOCATIONS ......................................................................................................................................................... 53
HEADER INFORMATION ........................................................................................................................................ 53
THIS SUBMISSION IS ............................................................................................................................................ 53
ENTITY NAME ...................................................................................................................................................... 53
DATE .................................................................................................................................................................. 53
PRINCIPAL INVESTIGATOR .................................................................................................................................... 53
PI NAME ............................................................................................................................................................. 53
PI DOJ NUMBER ................................................................................................................................................. 53
PI DATE OF BIRTH ............................................................................................................................................... 54
PI TIER 1 ACCESS ............................................................................................................................................... 54
UPDATE PI HEADER BUTTON................................................................................................................................ 54
SECTION 7A TABLE ............................................................................................................................................. 54
SELECT AGENT/TOXIN/REGULATED NUCLEIC ACID ............................................................................................... 54
LOCATION ........................................................................................................................................................... 55
LABORATORY OR STORAGE ................................................................................................................................. 55
LABORATORY SAFETY LEVEL ............................................................................................................................... 55
SUITE LEGEND .................................................................................................................................................... 57
EXAMPLES FOR COMPLETING THE SECTION 7A TABLE .......................................................................................... 57
SECTION 7B - STRAIN OR SEROTYPE DESIGNATION INFORMATION ........................................................ 62
HEADER INFORMATION (IF COMPLETING A STAND-ALONE SECTION 7B ONLY) .......................................................... 62
THIS SUBMISSION IS ............................................................................................................................................ 62
ENTITY NAME ...................................................................................................................................................... 62
DATE .................................................................................................................................................................. 62
PI ....................................................................................................................................................................... 62
SELECT AGENT/TOXIN ......................................................................................................................................... 62
STRAIN OR SEROTYPE DESIGNATIONS .................................................................................................................. 62
EXAMPLE FOR COMPLETING THE SECTION 7B TABLE ............................................................................................ 66
SECTION 7C - DESCRIPTION OF WORK .......................................................................................................... 67
HEADER INFORMATION (IF COMPLETING A STAND-ALONE SECTION 7C ONLY) .......................................................... 67
THIS SUBMISSION IS ............................................................................................................................................ 67
ENTITY NAME ...................................................................................................................................................... 67

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

DATE .................................................................................................................................................................. 67
PI ....................................................................................................................................................................... 67
QUESTION 1, OBJECTIVE OF W ORK ...................................................................................................................... 67
EXAMPLE FOR COMPLETING THE SECTION 7C TABLE ............................................................................................ 68
QUESTION 2, MAXIMUM QUANTITY/CONCENTRATION OF SELECT AGENT ................................................................ 69
EXAMPLES FOR COMPLETING THE SECTION 7C, QUESTION 2 ................................................................................ 69
QUESTION 3, MAXIMUM QUANTITY OF FUNCTIONAL TOXIN..................................................................................... 70
EXAMPLES FOR COMPLETING THE SECTION 7C, QUESTION 3 ................................................................................ 70
QUESTION 4, EQUIPMENT AEROSOLS ................................................................................................................... 70
QUESTION 5, RESPONSIBILITY FOR INVENTORY ..................................................................................................... 70
QUESTION 6, REGULATED NUCLEIC ACIDS............................................................................................................ 71
QUESTION 7, DECONTAMINATION ......................................................................................................................... 71
QUESTION 8, SECURITY OF W RITTEN RECORDS ................................................................................................... 71
QUESTION 9, SPECIFIC TYPES OF W ORK .............................................................................................................. 71
QUESTION 10, BSL3AG OR BSL4 LABORATORIES ................................................................................................ 72
ATTACHMENT A - WORK WITH TOXINS .......................................................................................................... 73
SELECT TOXIN ADDITIONAL INFORMATION ............................................................................................................ 73
NOTES: ............................................................................................................................................................... 74
HEADER INFORMATION ........................................................................................................................................ 75
THIS SUBMISSION IS ............................................................................................................................................ 75
ENTITY NAME ...................................................................................................................................................... 75
DATE .................................................................................................................................................................. 75
PI ....................................................................................................................................................................... 75
LABORATORY SAFETY LEVEL: .............................................................................................................................. 75
QUESTION 1, CHEMICAL HYGIENE PLAN ............................................................................................................... 75
QUESTION 2, TOXIN MANIPULATION OR PRODUCTION............................................................................................ 75
QUESTION 3, ANIMAL EXPOSURE ......................................................................................................................... 76
QUESTION 4, TOXIN PRODUCTION ........................................................................................................................ 76
EXAMPLES FOR COMPLETING ATTACHMENT A, QUESTION 4 .................................................................................. 76
QUESTION 5, HAZARD SIGN ................................................................................................................................. 76
QUESTION 6, SELECT TOXIN INACTIVATION ........................................................................................................... 76
QUESTION 7, DILUTION/MANIPULATION OF CONCENTRATED SELECT TOXINS.......................................................... 77
QUESTION 8, INTRA-ENTITY SELECT TOXIN TRANSFERS ........................................................................................ 77
QUESTION 9, INTER-ENTITY SELECT TOXIN TRANSFERS ........................................................................................ 77
QUESTION 10, COMMERCIAL DISTRIBUTION .......................................................................................................... 78
QUESTION 11, RECOMBINANT W ORK ................................................................................................................... 78
ATTACHMENT B - WORK WITH REGULATED NUCLEIC ACIDS, GENETIC MODIFICATION OF SELECT
AGENTS OR TOXINS, RECOMBINANT/SYNTHETIC NUCLEIC ACIDS, OR RECOMBINANT SYNTHETIC
ORGANISMS ........................................................................................................................................................ 79
HEADER INFORMATION ........................................................................................................................................ 79
THIS SUBMISSION IS ............................................................................................................................................ 79
ENTITY NAME ...................................................................................................................................................... 79
DATE .................................................................................................................................................................. 79
PI ....................................................................................................................................................................... 79
LABORATORY SAFETY LEVEL: .............................................................................................................................. 79
QUESTION 1, POSSESSION, USE, OR TRANSFER ................................................................................................... 79
QUESTION 2, RECOMBINANT W ORK...................................................................................................................... 80
QUESTION 3, RESTRICTED EXPERIMENTS ............................................................................................................. 81
QUESTION 4, PRODUCTS OF A RESTRICTED EXPERIMENT...................................................................................... 82
QUESTION 5, ENHANCED/RESTORED VIRULENCE .................................................................................................. 82
QUESTION 6, W ORK DESCRIPTION ....................................................................................................................... 83
EXAMPLES FOR COMPLETING ATTACHMENT B, QUESTION 6 .................................................................................. 83
Example 1, yes to Question 1a ........................................................................................................................ 83
Example 2, yes to Questions 1a and1b............................................................................................................ 83
Example 3, yes to Question 5 .......................................................................................................................... 83

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

QUESTION 7, INSTITUTIONAL BIOSAFETY COMMITTEE REVIEW /APPROVAL .............................................................. 83
ATTACHMENT C - WORK WITH ANIMALS ....................................................................................................... 84
HEADER INFORMATION ........................................................................................................................................ 84
THIS SUBMISSION IS ............................................................................................................................................ 84
ENTITY NAME ...................................................................................................................................................... 84
DATE .................................................................................................................................................................. 84
PI ....................................................................................................................................................................... 84
LABORATORY SAFETY LEVEL ............................................................................................................................... 84
QUESTION 1, SELECT AGENTS/TOXINS, ANIMALS AND ROUTES OF ADMINISTRATION .............................................. 84
EXAMPLES FOR COMPLETING THE ATTACHMENT C, QUESTION 1 ........................................................................... 85
Example 1: ........................................................................................................................................................ 85
Example 2: ........................................................................................................................................................ 85
QUESTION 2, AEROSOL EXPOSURES .................................................................................................................... 85
QUESTION 3, W ASTE STREAM.............................................................................................................................. 85
Example for Question 3a: ................................................................................................................................. 85
Example for Question 3b: ................................................................................................................................. 86
QUESTION 4, INACTIVATION ................................................................................................................................. 86
EXAMPLE FOR COMPLETING THE ATTACHMENT C, QUESTION 4 ............................................................................. 86
QUESTION 5, INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) ........................................................... 86
QUESTION 6, AAALAC ACCREDITATION ............................................................................................................... 86
QUESTION 7, ANIMAL TRACKING .......................................................................................................................... 87
QUESTION 8, ANIMAL RESTRAINT ......................................................................................................................... 87
QUESTION 9, ANIMAL MONITORING ...................................................................................................................... 87
QUESTION 10, ANIMAL HOUSING .......................................................................................................................... 87
EXAMPLE FOR COMPLETING THE ATTACHMENT C, QUESTION 10 ........................................................................... 88
QUESTION 11, METHOD OF EUTHANASIA .............................................................................................................. 88
QUESTION 12, NECROPSIES ................................................................................................................................ 88
EXAMPLE FOR COMPLETING ATTACHMENT C, QUESTION 12 .................................................................................. 88
QUESTION 13, SECURING ANIMAL CARCASSES ..................................................................................................... 88
ATTACHMENT D - WORK WITH PLANTS ......................................................................................................... 89
HEADER INFORMATION ........................................................................................................................................ 89
THIS SUBMISSION IS ............................................................................................................................................ 89
ENTITY NAME ...................................................................................................................................................... 89
DATE .................................................................................................................................................................. 89
PI ....................................................................................................................................................................... 89
LABORATORY SAFETY LEVEL ............................................................................................................................... 89
QUESTION 1, SELECT AGENTS, PLANTS AND ROUTES OF INOCULATION ................................................................. 89
EXAMPLE FOR COMPLETING ATTACHMENT D, QUESTION 1 .................................................................................... 90
QUESTION 2, PLANT W ASTE TREATMENT ............................................................................................................. 90
QUESTION 3, VECTORS ....................................................................................................................................... 90
QUESTION 4, GLASS HOUSE ................................................................................................................................ 90
QUESTION 5, GREENHOUSE ................................................................................................................................. 90
QUESTION 6, SCREEN HOUSE .............................................................................................................................. 90
QUESTION 7, GROWTH CHAMBER ........................................................................................................................ 90
QUESTION 8, RECOMBINANT W ORK...................................................................................................................... 91
ATTACHMENT E - WORK WITH ARTHROPODS .............................................................................................. 92
HEADER INFORMATION ........................................................................................................................................ 92
THIS SUBMISSION IS ............................................................................................................................................ 92
ENTITY NAME ...................................................................................................................................................... 92
DATE .................................................................................................................................................................. 92
PI ....................................................................................................................................................................... 92
LABORATORY SAFETY LEVEL ............................................................................................................................... 92
QUESTION 1, FIELD-COLLECTED ARTHROPODS .................................................................................................... 92
QUESTION 2, EXPERIMENTAL INOCULATIONS ........................................................................................................ 93

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

QUESTION 3, SELECT AGENTS AND ARTHROPODS ................................................................................................ 93
EXAMPLE FOR COMPLETING ATTACHMENT E, QUESTION 3 .................................................................................... 93
QUESTION 4, EXPOSURE ROUTES ........................................................................................................................ 93
QUESTION 5, CONTAINMENT AND TRANSFER OF INFECTED ARTHROPODS .............................................................. 94
QUESTION 6, INFECTED ARTHROPODS RECORDS .................................................................................................. 94
QUESTION 7, CONTAINMENT DESIGN AND OPERATIONAL PROCEDURES ................................................................. 94
QUESTION 8, INSTITUTIONAL BIOSAFETY COMMITTEE REVIEW /APPROVAL .............................................................. 94
QUESTION 9, RELEASE PREVENTION .................................................................................................................... 95
QUESTION 10, INFECTED ARTHROPOD CONTACT AND RELEASE PREVENTION ........................................................ 95
QUESTION 11, VENTILATION ESCAPE BARRIERS ................................................................................................... 95
QUESTION 12, FLOOR DRAINS ............................................................................................................................. 95
QUESTION 13, PLUMBING ESCAPE BARRIERS ....................................................................................................... 96
QUESTION 14, DISPOSAL ..................................................................................................................................... 96
QUESTION 15, W ASTE TREATMENT ...................................................................................................................... 96
QUESTION 16, ANIMALS/PLANTS IN ARTHROPOD CONTAINMENT LABORATORY ....................................................... 96
ATTACHMENT F - BSL3 AG LABORATORIES ................................................................................................. 97
HEADER INFORMATION ........................................................................................................................................ 97
THIS SUBMISSION IS ............................................................................................................................................ 97
ENTITY NAME ...................................................................................................................................................... 97
DATE .................................................................................................................................................................. 97
PI ....................................................................................................................................................................... 97
QUESTION 1, SUPPLY, MATERIAL AND EQUIPMENT DECONTAMINATION .................................................................. 97
QUESTION 2, SHOWER ........................................................................................................................................ 97
QUESTION 3, DISPOSABLE MATERIAL DECONTAMINATION...................................................................................... 98
QUESTION 4, CONTAINMENT AREA CONSTRUCTION .............................................................................................. 98
QUESTION 5, AIRFLOW MONITORING .................................................................................................................... 98
QUESTION 6, HEPA FILTRATION .......................................................................................................................... 98
QUESTION 7, LABORATORY PROCEDURES AND DESIGN FEATURES ........................................................................ 98
QUESTION 8, SECOND SHOWER ........................................................................................................................... 98
QUESTION 9, HUMANE RESTRAINING DEVICES ...................................................................................................... 98
QUESTION 10, LARGE ANIMAL NECROPSY ROOMS ................................................................................................ 99
ATTACHMENT G - BSL4/ABSL4 LABORATORIES ........................................................................................ 100
HEADER INFORMATION ...................................................................................................................................... 100
THIS SUBMISSION IS .......................................................................................................................................... 100
ENTITY NAME .................................................................................................................................................... 100
DATE ................................................................................................................................................................ 100
PI ..................................................................................................................................................................... 100
QUESTION 1, CABINET LABORATORY .................................................................................................................. 100
QUESTION 2, PERSONAL PROTECTIVE EQUIPMENT (CABINET LABORATORY) ........................................................ 100
QUESTION 3, DECONTAMINATION METHODS (CABINET LABORATORY) .................................................................. 100
QUESTION 4, LIQUID EFFLUENT DECONTAMINATION (CABINET LABORATORY)....................................................... 100
QUESTION 5, ROOM VENTILATION (CABINET LABORATORY) ................................................................................. 101
QUESTION 6, VENTILATION FAILURE (CABINET LABORATORY) .............................................................................. 101
QUESTION 7, AIRFLOW MONITORING (CABINET LABORATORY) ............................................................................. 101
QUESTION 8, CONTAINMENT PARAMETERS MONITORING (CABINET LABORATORY) ............................................... 101
QUESTION 9, SUIT LABORATORY ........................................................................................................................ 101
QUESTION 10, PERSONAL PROTECTIVE EQUIPMENT (SUIT LABORATORY) ............................................................ 101
QUESTION 11, LIQUID EFFLUENT DECONTAMINATION (SUIT LABORATORY)........................................................... 101
QUESTION 12, ROOM VENTILATION (SUIT LABORATORY) ..................................................................................... 101
QUESTION 13, VENTILATION FAILURE (SUIT LABORATORY).................................................................................. 101
QUESTION 14, AIRFLOW MONITORING (SUIT LABORATORY) ................................................................................. 101
QUESTION 15, BREATHING AIR FAILURE (SUIT LABORATORY).............................................................................. 101
QUESTION 16, CONTAINMENT PARAMETERS MONITORING (SUIT LABORATORY) ................................................... 101

APHIS/CDC Form 1 Instructions

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Amendment Instructions
AMENDMENT REQUIREMENTS ....................................................................................................................... 102
AMENDMENT REQUESTS .................................................................................................................................... 102
EXAMPLES OF REQUEST LANGUAGE ................................................................................................................... 103
FEDERAL SELECT AGENT PROGRAM CONCURRENCE .......................................................................................... 104
AMENDMENT SUBMISSION.................................................................................................................................. 104
AMENDMENT REFERENCE TABLE ................................................................................................................. 105
PERSONNEL AMENDMENTS ........................................................................................................................... 107

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ADDING INDIVIDUALS – GENERAL INFORMATION .................................................................................................. 107
ADDING OR REACTIVATING A RO ........................................................................................................................ 108
ADDING OR REACTIVATING AN ARO ................................................................................................................... 109
ADDITION OR REACTIVATION OF OWNER/CONTROLLERS ..................................................................................... 110
ADDITION OR REACTIVATION OF LABORATORIANS OR ANIMAL CARE STAFF .......................................................... 111
ADDITION OR REACTIVATION OF SUPPORT STAFF ............................................................................................... 112
ADDITION OR REACTIVATION OF UNESCORTED VISITORS ..................................................................................... 113
ADDITION OR REACTIVATION OF A PI .................................................................................................................. 114
REMOVAL OF RO, ARO, OR OWNER/CONTROLLER ............................................................................................. 115
REMOVAL OF LABORATORIANS, ANIMAL CARE STAFF, SUPPORT STAFF, AND UNESCORTED VISITORS ................... 117
REMOVAL OF A PI .............................................................................................................................................. 118
UPDATE TO PI NAME ......................................................................................................................................... 121
UPDATE TO RO, ARO OR OWNER/CONTROLLER NAME OR CONTACT INFORMATION ............................................. 122
UPDATE TO AN INDIVIDUAL’S ACCESS TO TIER 1 AGENTS/TOXIN .......................................................................... 123
SELECT AGENT/TOXIN AMENDMENTS.......................................................................................................... 124
ADDITION OF SELECT AGENT/TOXIN ................................................................................................................... 124
ADDITION OF TIER 1 SELECT AGENT/TOXIN ........................................................................................................ 124
UPDATE POSSESSION STATUS OF SELECT AGENTS/TOXINS ................................................................................ 126
REMOVAL OF SELECT AGENT/TOXIN FROM THE ENTITY ....................................................................................... 127
REMOVAL OF SELECT AGENT/TOXIN FROM A PI (BUT NOT THE ENTITY) ................................................................ 128
ADDITION OF NEW W ORK................................................................................................................................... 129
REMOVAL OF W ORK .......................................................................................................................................... 130
STRAIN UPDATE ................................................................................................................................................ 131
FACILITY AMENDMENTS ................................................................................................................................. 132
ADDITION OF A SUITE/ROOM .............................................................................................................................. 132
REMOVAL OF SUITE/ROOM ................................................................................................................................ 134
UPDATE TO BUILDING AND SUITE/ROOM SPECIFIC SECURITY .............................................................................. 135
UPDATE TO SUITE/ROOM PHYSICAL INFORMATION .............................................................................................. 136
OTHER AMENDMENTS ..................................................................................................................................... 137
ENTITY NAME OR ADDRESS CHANGES ................................................................................................................ 137
UPDATE TO ENTITY INSTITUTIONAL MISSION, FUNCTION AND/OR SIZE .................................................................. 138
UPDATE TO ENTITY W IDE SECURITY AND INCIDENT RESPONSE............................................................................ 139
UPDATE TO ENTITY-W IDE BIOSAFETY/BIOCONTAINMENT ..................................................................................... 140
UPDATE TO ENTITY ENTRY REQUIREMENTS FOR FEDERAL SELECT AGENT PROGRAM INSPECTORS ...................... 141
WITHDRAWAL REQUESTS .............................................................................................................................. 142
AMENDMENT W ITHDRAWAL ................................................................................................................................ 142
REGISTRATION W ITHDRAWAL ............................................................................................................................. 143
DEFINITIONS ...................................................................................................................................................... 144

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

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Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Definitions and terms used throughout this document can be found in
the Definitions Section at the end of the document.

Section 1A - Entity and Contact Information
Since all communication between a registering entity and APHIS and/or the CDC is completed
through the Responsible Official (RO) or alternate RO (ARO), it is imperative that the RO’s and ARO’s
contact information is kept current and accurate. If any Section 1 information changes, you must
immediately report the change(s) to APHIS or the CDC by submitting an update using the current
OMB approved APHIS/CDC Form 1. Verbal change requests cannot be accepted. If further
information or guidance is required contact the CDC at 404-718-2000 or APHIS at 301-851-3300
option 3.

This Submission Is


Check “A new registration” to indicate an initial application, or revision to a pending initial
application.
Note: Once your entity is registered, select “An update to an existing registration” to amend
your entity’s APHIS/CDC Form 1 or indicate “A renewal” if submitting a complete APHIS/CDC
Form 1 as part of the renewal process.

Date


Enter the date that the document is being submitted to APHIS/CDC in the following format
mm/dd/yyyy.

Entity Application Number


Leave this field blank if this is a new application. This number is assigned to an entity after
APHIS/CDC has accepted the initial application.
Note: The Entity Application Number, also called the Entity ID number, can be located on a
DOJ issuance letter, or the number can be provided by your file manager.

Current Registration Number


Leave this field blank if this is a new application. The Current Registration Number is assigned
to an entity after APHIS/CDC has approved an initial application or a subsequent renewal of
an existing registration.

Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.



Do not abbreviate the organization name (e.g., International Business Machine Corporation
instead of IBM).

Physical Address


Provide the complete physical address of the entity listed in the Entity Name field. This
address will be entered on the FD-961 and used to perform the entity security risk
assessment, if applicable.

APHIS/CDC Form 1 Instructions

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Note: The physical address may be different from the mailing address to which official
correspondence will be sent. The mailing address is entered under the Responsible Official
Information section below.

Additional Physical Address(es)


For an entity that has more than one physical address, enter additional addresses. Entities
with multiple laboratories with differing physical addresses (e.g., laboratory located on a
different campus of academic institution or a satellite facility) should list all relevant addresses.

Type of Entity


Refer to the definitions below when specifying the type of entity:
Note: Federal, State, or local governmental agencies, including public accredited academic
institutions, are exempt from the security risk assessments for the entity and the individual(s)
who owns or controls such entities. For other entity types, an individual(s) deemed to own or
control the entity must be identified and a security risk assessment must be performed for the
entity.
o Academic (Private) – a university that is neither owned nor controlled by any government
entity. This entity must identify an individual(s) that own or control the entity. For example,
if the individual is in a managerial or executive capacity with regard to the entity’s select
agents or toxins or with regard to the individuals who will have access to the select agents
or toxins possessed, used, or transferred by the entity, this individual would be considered
someone who owns or controls the entity.
o

Academic (State) – a university that is predominantly funded by public means through the
government. Public accredited academic institutions are exempt from the entity security
risk assessment requirement.

Commercial (Profit) – a privately owned company including partnerships and those
corporations either privately held or whose shares are traded on the open market. This
entity must identify individual(s) that own or control the entity. For example, 1) if an
individual owns 50 percent or more of the entity, or 2) is a holder or owner of 50 percent or
more of its voting stock or 3) an individual is in a managerial or executive capacity with
regard to the entity's select agents or toxins or with regard to the individuals with access to
the select agents or toxins possessed, used, or transferred by the entity, this individual
would be considered someone who owns or controls the entity.

Government (Federal) – an entity that is part of an agency of the Federal government.
These entities are exempt from the entity security risk assessment requirement.

Government (State/Local) – an entity that is part of an agency of a State or Local
government. An example would be a state or local laboratory that provides certain medical
and environmental laboratory services (testing, consultation and training) to the public and
is predominately funded by a state or local government. These entities are exempt from
the entity security risk assessment requirement.

Private, Non-Profit – a privately owned company including partnerships and corporations
no part of the income of which is distributed to its owners, directors, officers, members or
stockholders and whose principle purpose is for charitable or benevolent purposes. This
entity must identify individual(s) that own or control the entity. For example, 1) if an
individual owns 50 percent or more of the entity, or 2) is a holder or owner of 50 percent or
more of its voting stock or 3) an individual is in a managerial or executive capacity with

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

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Federal Select Agent Program website
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regard to the entity's select agents or toxins or with regard to the individuals with access to
the select agents or toxins possessed, used, or transferred by the entity, this individual
would be considered someone who owns or controls the entity.

Responsible Official Information
Refer to the definition below when designating a RO:
Responsible Official (RO) – the individual designated by an entity with the authority and control to
ensure compliance with the Select Agent Regulations.
Note: The role of the RO is independent of the organizational structure at the entity.
For additional information on the RO role and his/her responsibility to ensure compliance with the
Select Agent Regulations, refer to the Responsible Official Guidance Document.

RO Name (Last and First name)


Provide the full name of the applicant.
o

For the purposes of completing the APHIS/CDC Form 1, the term “full name” refers to an
individual's first name and last name or surname, without use of nicknames.
Note: The RO’s last name, first name and the date of birth must be identical to that
provided on the FD-961 Form submitted to Criminal Justice Information Services (CJIS).

RO DOJ Number


The DOJ Number field should be left blank for new applications. This number will be assigned
by CDC/APHIS and will be communicated to the entity for use in completion of the FD-961
Form submitted to CJIS for each individual.
Note: If the RO is also a PI, a corresponding Section 7 must be submitted.

RO Date of Birth


Enter the date of birth in the following format: mm/dd/yyyy.

RO Business Email Address


Provide the business email address for the RO listed above.



Print or type clearly; and ensure that you include the email domain (e.g., .org, .gov, .edu, .com,
.net)

RO Title


Provide the institutional title for the RO listed above.
Note: The role of the RO is independent of the organizational structure at the entity.

RO Tier 1 Access


Check box if this individual will have access or have the ability to access Tier 1 select agents
and toxins.
Note: Individuals that have access or have the ability to access Tier 1 select agents and toxins
require additional personnel security procedures. Refer to the Guidance for Suitability

APHIS/CDC Form 1 Instructions

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Assessments for additional information on pre-access suitability and ongoing suitability
assessments.

RO Business Telephone Number


Provide the direct dial 10-digit telephone number for the RO listed above; include an
extension, if required.

RO Business Fax Number


Provide the 10-digit facsimile number for the RO listed above.
Note: All official fax correspondence will be sent to the fax number specified for the RO unless
specifically requested otherwise by the entity. This number should reflect the primary work
location for the RO. The fax machine should have limited access due to the potentially
sensitive nature of the documents.

RO Emergency Telephone Number
The purpose of this emergency contact number is to provide APHIS or the CDC an after-hours
emergency number. This can be a cell phone or a home phone. The phone number will only be used
in emergency situations (e.g., natural disasters) when APHIS or the CDC is unable to reach the RO at
his/her designated business number.


Provide the direct dial 10-digit emergency telephone number for the RO listed above; include
an extension, if required.

RO Mailing Address


Provide a complete business mailing address for the RO listed above (NOT a post office box).
The mailing address for the RO should reflect the primary duty station for the RO and may be
different from the entity physical address listed on Section 1.
Note: Any official hardcopy correspondence will be sent to the mailing address specified for
the RO.

Alternate Responsible Official Information
Refer to the definition below when designating an ARO:
Alternate Responsible Official (ARO) – the individual(s) designated by an entity with the authority
and control to ensure compliance with the Select Agent Regulations in the absence of the
Responsible Official.
Note: Multiple AROs may be specified.

ARO Name (Last and First name)


Provide the full name of the applicant.
o

For the purposes of completing the APHIS/CDC Form 1, the term “full name” refers to an
individual's first name and last name or surname, without use of nicknames.
Note: The ARO’s last name, first name and the date of birth must be identical to that
provided on the FD-961 Form submitted to CJIS.

APHIS/CDC Form 1 Instructions

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ARO DOJ Number


The DOJ Number field should be left blank for new applications. This number will be assigned
by APHIS/CDC and will be communicated to the entity for use in completion of the FD-961
Form submitted to CJIS for each individual.
Note: If the ARO is also a PI, a corresponding Section 7 must be submitted.

ARO Date of Birth


Enter the date of birth in the following format: mm/dd/yyyy.

ARO’s Business Email Address


Provide the email address for the ARO listed above.



Print or type clearly; and ensure that you include the email domain (e.g., .org, .gov, .edu, .com,
.net)

ARO Title


Provide the institutional title for the ARO listed above.
Note: The role of the ARO is independent of the organizational structure at the entity.

ARO Tier 1 Access


Check box if this individual will have access (e.g., the ability to carry, use, or manipulate) or
have the ability to access Tier 1 select agents and toxins.
Note: Individuals that have access or have the ability to access Tier 1 select agents and toxins
require additional personnel security procedures. Refer to the Guidance for Suitability
Assessments for additional information on pre-access suitability and ongoing suitability
assessments.

ARO Business Telephone Number


Provide the direct dial 10-digit telephone number for the ARO listed above; include an
extension, if required.

ARO Business Fax Number


Provide the 10-digit facsimile number for the ARO listed above.
Note: All official fax correspondence will be sent to the fax number specified for the RO
unless specifically requested by the entity.

ARO Emergency Telephone Number
The purpose of this emergency contact number is to provide APHIS or the CDC an after-hours
emergency number. This can be a cell phone or a home phone. The phone number will only be used
in emergency situations (e.g., natural disasters) when APHIS or the CDC is unable to reach the ARO
at his/her designated business number.


Provide the direct dial 10-digit emergency telephone number for the ARO listed above; include
an extension, if required.

APHIS/CDC Form 1 Instructions

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Federal Select Agent Program website
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ARO Mailing Address


Provide a complete business mailing address for the ARO listed above (NOT a post office
box). The mailing address for the ARO should reflect the primary duty station for the ARO and
may be different from the entity physical address listed on Section 1.
Note: Any official hardcopy correspondence will be sent to the mailing address specified for
the RO.

Owner/Controller Information
Refer to the definition below when specifying an Owner/Controller.
An individual is considered an Owner/Controller if the individual owns 50 percent or more of the
entity, and/or is a holder or owner of 50 percent or more of the entity’s voting stock, and/or is an
individual who is in a managerial or executive capacity with regard to the entity's select agents or
toxins or with regard to the individuals with access to the select agents or toxins possessed, used,
or transferred by the entity.
Note: Multiple Owner/Controllers may be specified.

Owner/Controller Name (Last and First name)


Provide the full name of the applicant.
o

For the purposes of completing the APHIS/CDC Form 1, the term “full name” refers to an
individual's first name and last name or surname, without use of nicknames.
Note: The Owner/Controller’s last name, first name and the date of birth must be identical
to that provided on the FD-961 Form submitted to CJIS.

Owner/Controller DOJ Number


The DOJ Number field should be left blank for new applications. This number will be assigned
by CDC/APHIS and will be communicated to the entity for use in completion of the FD-961
Form submitted to CJIS for each individual.
Note: If the Owner/Controller is also a PI, a corresponding Section 7 must be submitted.

Owner/Controller Date of Birth


Enter the date of birth in the following format: mm/dd/yyyy.

Owner/Controller Tier 1 Access


APHIS/CDC Form 1 Instructions

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Section 1B - Certificate of Responsibility
RO/ARO Signatures


If your entity does not have a current registration with either APHIS or the CDC, you must
submit written or digital signatures and signing date from the RO and all AROs.



If submitting an amendment to a pending application to change/update name for the RO,
add/remove/update name for an ARO, or update entity information, you must submit written or
digital signatures from the RO and all AROs using Section 1B of APHIS/CDC Form 1.

APHIS/CDC Form 1 Instructions

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Section 1C - Entity Abstract
•Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


Enter the date that the document is being submitted to APHIS/CDC in the following format
mm/dd/yyyy.
Note: This header information must be consistent for all sections and attachments submitted
at one time.

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 collaboration. 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.
If further information or guidance is required, contact the CDC at 404-718-2000 or APHIS at 301-8513300 option 3.

APHIS/CDC Form 1 Instructions

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Section 2 - RO Certification of Personnel and Facility Activities
Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


RO Signature


If your entity does not have a current registration with either APHIS or the CDC, the RO must
read each line and manually or digitally sign where indicated. An ARO may not sign in place
of the RO. A completed Section 2 is also required as part of the complete Form 1 required for
registration renewal.
Note: Refer to the Responsible Official Guidance Document.
Note: Refer to Section 9 of the Select Agent Regulations (42 CFR Part 73, 9 CFR Part 121,
and 7 CFR Part 331).
Additional Information


By signing the bottom of Section 2, the RO is certifying that, as of the date
indicated on the application or amendment submitted to the FSAP, all information
is current and accurate and these requirements are met. This includes ensuring
that plans are written and provisions and procedures described are in effect at
the time of submission of the application, in accordance with the requirements of
the Select Agent Regulations.



The entity must develop and implement a site-specific security plan that is
sufficient to safeguard the select agent or toxin against unauthorized access,
theft, loss, or release. In developing a security plan, it is recommended that an
entity or individual refer to the Security Guidance for Select Agent or Toxin
Facilities.

APHIS/CDC Form 1 Instructions

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Additional Information


Access to select agents or toxins must only be granted to those individuals with
access approval from the APHIS Administrator or HHS Secretary following a
security risk assessment conducted by the Attorney General. In addition, if the
entity is registered for Tier 1 select agents and toxins, the entity must limit access
to a Tier 1 select agent or toxin to only those individuals who are approved by the
HHS Secretary or APHIS Administrator, following a security risk assessment by
the Attorney General, have had an entity-conducted pre-access suitability
assessment, and are subject to the entity’s procedures for ongoing suitability
assessment.



The entity must develop and implement an agent-specific, site-specific
biosafety/biocontainment plan that meets the requirements of Section 12 of the
Select Agent Regulations. In developing a biosafety/biocontainment plan, an
individual or entity should consider the current edition of the BMBL, the
Occupational Safety and Health Administration (OSHA) regulations in 29 CFR
Parts 1910.1200 and 1910.1450 for toxins, and the National Institutes of Health
(NIH) Guidelines for Research Involving Recombinant DNA Molecules for
recombinant work. The biosafety/biocontainment plan must contain sufficient
information and documentation to describe the biosafety and containment
procedures.



The entity must develop and implement an incident response plan that meets the
requirements of Section 14 of the Select Agent Regulations. In developing an
incident response plan, the entity should consider the Incident Response in
Select Agent or Toxin Facilities guidance available at SelectAgents.gov. The
incident response plan must fully describe the entity's response procedures for
the theft, loss, or release of a select agent or toxin, inventory discrepancies,
security breaches (including information systems), severe weather and other
natural disasters, workplace violence, bomb threats, suspicious packages, and
emergencies such as fire, gas leak, explosion, power outage, etc. The response
procedures must account for hazards associated with the select agent or toxin.



The security, biosafety and incident response plans must be reviewed and
revised, as necessary, after any drill or exercise and after any incident. The
review must occur at least annually. Drills or exercises must be conducted at
least annually to test and evaluate the effectiveness of the plans.



An entity must provide information and training on biosafety, security (including
security awareness) and incident response to each individual with access
approval from the HHS Secretary or APHIS Administrator before he/she has
such access. The training must address the particular needs of the individual, the
work they will do, and the risks posed by the select agents or toxins. Refresher
training must be provided at least annually as well as when the entity significantly
amends its security, incident response, or biosafety plans. A record of each
individual’s training must be maintained in an electronic or paper format and must
include the name of the individual, the date of training, a description of the
training provided, and the means used to verify that the employee understood the
training. These records must be promptly produced upon request and maintained

APHIS/CDC Form 1 Instructions

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Additional Information
for 3 years. Refer to the Guidance for Training Requirements for additional
information.

APHIS/CDC Form 1 Instructions

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Section 3 - Select Agents and Toxins
Complete the Select Agent/Toxin table to indicate each select agent (genus and species), toxin or
regulated nucleic acid for which the entity wishes to register.
If further information or guidance is required, contact the CDC at 404-718-2000 or APHIS at 301-8513300 option 3.

Header Information


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


A subset of select agents and toxins have been designated as Tier 1 because these biological agents
and toxins present the greatest risk of deliberate misuse with significant potential for mass casualties
or devastating effects to the economy, critical infrastructure, or public confidence, and pose a severe
threat to public health and safety:

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Tier 1 Select Agents and Toxins
HHS Agents and Toxins
Bacillus cererus Biovar anthracis
Botulinum neurotoxins
Botulinum neurotoxin producing
species of Clostridium
Ebola virus
Francisella tularensis
Marburg virus
Variola major virus (Smallpox virus)
Variola minor virus (Alastrim)
Yersinia pestis

Overlap Agents
(1)

Bacillus anthracis
Burkholderia mallei
Burkholderia pseudomallei

USDA Agents
Foot-And-Mouth Disease
virus
Rinderpest virus

(1) Bacillus anthracis (Pasteur strain) is a separate, non-Tier 1 select agent and must be
registered separately from the Tier 1 select agent.
Notes: a) An entity must list at least one select agent or toxin in order to be registered with the FSAP.
b) An entity is not authorized to possess, use and/or transfer select agents and/or toxins
without an approved registration certificate.
c) Entities must register for the possession, use, or transfer of select agents and toxins,
including regulated nucleic acids (e.g., positive strand RNA viruses) and recombinant and/or
synthetic construct(s) that encode for the functional form of select toxins as defined in Section
3(c) and Section 4(c) of the Select Agent Regulations (42 CFR Part 73, 9 CFR Part 121, and
7 CFR Part 331).
d) An entity should consider the current edition of the BMBL containment recommendations
for each select agent and toxin based on the entity’s proposed work objectives. The biosafety
level of the laboratory where the select agent or toxin will be used should be consistent with
the BMBL guidelines.
e) After a formal request, evaluation and approval by the FSAP, certain strains, genotypes,
biotypes, or subgroups of select agents or toxins may be excluded from regulation. The
exclusion of a strain of a select biological agent or toxin is based on adequate evidence that it
does not pose a severe threat to public health and safety, and/or animal health, plant health,
and animal or plant products. Excluded strains are usually sought out and approved for use in
basic or applied research, as positive controls, for diagnostic assay development, or for the
development of vaccines and therapeutics. However, an individual or entity that possesses,
uses, or transfers an excluded strain will again be subject to the regulations if there is any
reintroduction of factor(s) associated with virulence or other manipulations of any kind that
modify the attenuation such that virulence is restored or enhanced. Unless specifically
excluded under 42 CFR 73.3 and 73.4, 7 CFR 331.3 and 331.4, and 9 CFR 121.3 and 121.4,
any select agent or toxin is subject to the entirety of the Select Agent Regulations. The
current list of select agent exclusions can be viewed at Select Agents and Toxins Exclusions.
f) Chimeric viruses whose genomes contain the backbone and replication machinery of a
select agent virus or contain genes from different select agent viruses are regulated.
Regulated chimeric viruses have to be evaluated on a case-by-case basis to determine if the
viruses exhibit sufficient attenuation to be excluded. Chimeras that are comprised of select
agent and non-select agent genes from the same virus family require careful review to
determine select agent status. It is the entity’s responsibility to determine if the resultant

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chimera is a select agent; however, the FSAP encourages entities to submit these types of
chimeras for review.






List only one select agent or toxin per box.
Do not list any biological agents or toxins that are not on the current, approved Select
Agent/Toxin List.
Enter the select agent or toxin in the appropriate column (HHS, Overlap, USDA Agents)
exactly as they appear on the current, approved Select Agent/Toxin List. Do not
abbreviate.
If you need to remove an entry, choose the “blank” at the top of the drop down list in the
PDF.
Enter regulated nucleic acids exactly as they appear below:

HHS Select Agent and Toxin Regulated Nucleic Acids
Genomic material – Eastern Equine Encephalitis virus
Genomic material – Kyasanur Forest disease virus
Genomic material – Omsk Hemorrhagic Fever virus
Genomic material – SARS–associated coronavirus
Genomic material – Tick-borne encephalitis virus, Far Eastern subtype
Genomic material – Tick-borne encephalitis virus, Siberian subtype
Recombinant/synthetic nucleic acids encoding Abrin
Recombinant/synthetic nucleic acids encoding Botulinum neurotoxin
Recombinant/synthetic nucleic acids encoding Conotoxins
Recombinant/synthetic nucleic acids encoding Ricin
Recombinant/synthetic nucleic acids encoding Staphylococcal enterotoxin
Overlap Select Agent Regulated Nucleic Acids
Genomic material – Venezuelan Equine Encephalitis virus
USDA Veterinary Services (VS) Select Agent Regulated Nucleic Acids
Genomic material – Classical Swine Fever virus
Genomic material – Foot-And-Mouth Disease virus
Genomic material – Swine Vesicular Disease virus

Additional Information


Section 3 must include regulated nucleic acids listed above if you possess,
transfer and/or use extracted and isolated nucleic acids that meet the
requirements defined in section 3(c) and section 4(c) of the Select Agent
Regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331).



The registration of intact, live agent is sufficient to cover the genomic material in
that agent as long as it is not extracted and isolated for further testing or research
purposes.



For additional information regarding regulated nucleic acids, refer to Guidance on
the Regulation of Select Agent and Toxin Nucleic Acids.

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Check if Select Agent/Toxin Possessed


New applicants who do not already have an approved registration certificate must leave this
box unchecked because the entity has not yet been authorized to possess select agents
and/or toxins.



After approved to possess select agents and/or toxins, the entity will need to submit an
updated Section 3 and Section 7B indicating which select agents and/or toxins are in its
possession within 7 days of acquiring those agents or toxins. See Amendment Requirements
for how to update this information upon acquiring a select agent and/or toxin.



Indicate toxin is possessed if you are registered for a select toxin but possess below the
regulated amount.
Note: A registered entity is required to meet all of the regulatory requirements for each select
agent and/or toxin listed on the APHIS/CDC Form 1 regardless of whether the select agent or
toxin is in the actual possession of the entity and without regard to the actual amounts of
toxins in possession. Refer to the Policy Statement posted to the FSAP website August 25,
2014 for more information.

Examples for Completing the Section 3 Table
This section is intended to provide examples on how to complete the Section 3 table for the most
common application conditions.


Example: An entity wishes to register for work with two select agents, Bacillus anthracis and
Yersinia pestis. The entity has not yet been approved to work with select agents or toxins.



Example: An entity wishes to register for work with SARS-associated coronavirus and its viral
genomic material. The entity has not yet been approved to work with select agents or toxins.

APHIS/CDC Form 1 Instructions

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Section 4A - Laboratorians and Animal Care Staff
Complete this section by providing the information for all Laboratorians and Animal Care Staff. An
individual will be deemed to have access at any point in time if the individual has possession of a
select agent or toxin (e.g., ability to carry, use, or manipulate) or the ability to gain possession of a
select agent or toxin [7 CFR Part 331.10(b), 9 CFR Part 121.10 and 42 CFR Part 73.10(b)].
This section can be completed using either the pdf or excel version found at
http://www.selectagents.gov/form1.html. If further information or guidance is required, contact the
CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.
Refer to the definition below when specifying a Laboratorian or Animal Care Staff.


Laboratorians and Animal Care Staff– an individual who performs any of the work listed in a
Section 7C, Question 1 and manipulates select agents or toxins or handles select agent
infected animals, plant hosts or select agent contaminated hazardous waste (including animal
bedding).

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


Tier 1 Access


Check box if this individual will have access or have the ability to access Tier 1 select agents
or toxins or handle Tier 1 select agent inoculated animals, plant hosts or select agent
contaminated hazardous waste (including animal bedding).
Note: Individuals that have access or have the ability to access Tier 1 select agents and toxins
require additional personnel security procedures. Refer to the Guidance for Suitability
Assessments for additional information on pre-access suitability and ongoing suitability
assessments.

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Name (Last and First name)


Provide the full name of the individual.
Note: For the purposes of completing the APHIS/CDC Form 1, the term “full name” refers to
an individual's first name and last name or surname, without use of nicknames.

DOJ Number


Date of Birth


Enter the date of birth in the following format: mm/dd/yyyy.

Role


Select the role below which most closely matches the individual’s primary responsibilities:



Laboratorian
Animal Care Staff

Note: Select only one role per individual.

Supervising Principal Investigator (PI)


For each individual, you must list the PI or PIs who control(s) the use of the select agents and
toxins that each Laboratorian or Animal Care Staff will work with.



If an individual works with more than one PI, list each principal investigator in the “Supervising
Principal Investigator” column.



If the person will work with all PIs, the term "All PIs" should be listed in the “Supervising
Principal Investigator” column for that individual.

RO/ARO Signature


An RO or ARO must manually or digitally sign and date Section 4A. If multiple pages are
needed, the RO/ARO may sign and date the last page.
Additional Information


An entity must provide information and training on biosafety, security (including
security awareness), and incident response to each individual with access
approval from the HHS Secretary or APHIS Administrator before he/she has
such access. The training must address the particular needs of the individual, the
work they will do, and the risks posed by the select agents or toxins.



Refresher training must be provided at least annually as well as when the entity
significantly amends its security, incident response, or biosafety plans.



A record of each individual’s training must be maintained in an electronic or
paper format and must include the name of the individual, the date of training, a
description of the training provided, and the means used to verify that the
employee understood the training. These records must be promptly produced

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Additional Information
upon request and maintained for 3 years. Refer to the Guidance for Training
Requirements for additional information.

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Section 4B - Support Staff
Complete this section by providing the information for all Support Staff. An individual will be deemed
to have access at any point in time if the individual has possession of a select agent or toxin (e.g.,
ability to carry, use, or manipulate) or the ability to gain possession of a select agent or toxin [7 CFR
Part 331.10(b), 9 CFR Part 121.10 and 42 CFR Part 73.10(b)].
This section can be completed using either the pdf or excel version found at
http://www.selectagents.gov/form1.html. If further information or guidance is required, contact the
CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.
Refer to the definition below when specifying Support Staff:


Support Staff – an individual who provides an indirect service in support of the direct work
with select agents or toxins, does not work with select agents or toxins or select agent infected
animals, bedding or plant hosts, but could potentially gain access to select agents/toxins.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


Tier 1 Access


Name


Provide the full name of the applicant.

APHIS/CDC Form 1 Instructions

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Note: For the purposes of completing the APHIS/CDC Form 1, the term “full name” refers to
an individual's first name and last name or surname, without use of nicknames.

DOJ Number


Date of Birth


Enter the date of birth in the following format: mm/dd/yyyy

Role


Select the role below which most closely matches the individual’s responsibilities:









IT
Security
Safety
Administrative
Maintenance
Janitorial
Shipping/Receiving
Other (individuals who do not fall under one of the roles above)

Note: Select only one role per individual.

RO/ARO Signature


An RO or ARO must manually or digitally sign and date Section 4B. If multiple pages are
needed, the RO/ARO may sign and date the last page. No supervising PI is required to be
designated as the RO is responsible for ensuring compliance with the Select Agent
Regulations for these personnel.
Additional Information




Refresher training must be provided at least annually as well as when the entity
significantly amends its security, incident response, or biosafety plans.



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Section 4C - Unescorted Visitors
Complete this section by providing the information for all visitors that are SRA approved at another
entity and will be performing work with, or have access to, select agents and/or toxins at your
facility. An individual will be deemed to have access at any point in time if the individual has
possession of a select agent or toxin (e.g., ability to carry, use, or manipulate) or the ability to gain
possession of a select agent or toxin [7 CFR Part 331.10(b), 9 CFR Part 121.10 and 42 CFR Part
73.10(b)].
This section can be completed using either the pdf or excel version found at
http://www.selectagents.gov/form1.html. If further information or guidance is required, contact the
CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.
Visitors that are continually escorted as described in Section 11(d)(2) of the Select Agent Regulations
(42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331) do not require the documentation below.
These individuals must not work with, have access to, or have the ability to have access to select
agents or toxins while visiting registered room(s).
Unescorted Visitor – an individual who has access approval at a registered entity (the “home” entity)
other than yours (the “host entity”) and will temporarily work with, or have access to, select agents or
toxins, and receive site-specific training, at your registered entity. Additional information for visitors
can be found on the Select Agents website located at Security Risk Assessments FAQ's under the
Visitors section.
Note: Visitors should only be listed on Section 4C.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


Tier 1 Access


Check box if this individual will have access or have the ability to access Tier 1 select agents
and toxins.

APHIS/CDC Form 1 Instructions

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Note: Individuals that have access or have the ability to access Tier 1 select agents and toxins
require additional personnel security procedures. Refer to the Guidance for Suitability
Assessments for additional information on pre-access suitability and ongoing suitability
assessments for visitors.

Name


Provide the full name of the applicant.
Note: For the purposes of completing the APHIS/CDC Form 1, the term “full name” refers to
an individual's first name and last name or surname, without use of nicknames.

Home Entity DOJ Unique Identifier Number


Enter the DOJ Number the individual is assigned at their home entity. A home entity is defined
as the entity where the individual’s current SRA approval was granted.
Note: The DOJ number for the home entity will continue to be listed for the individual on
subsequent Section 4C submissions. Do not use the Host Entity DOJ number.

Unescorted Visitor Date of Birth


Enter the date of birth in the following format: mm/dd/yyyy.

Unescorted Visitor Supervising Principal Investigator


For each individual you must list the PI or PIs who control(s) the use of the select agents and
toxins that the person will work with or provide support services for.



If an individual works with more than one PI, list each PI in the supervising PI column.



If the person will work with or support all PIs, the term "All PIs" should be listed in the PI
column for that individual.

RO/ARO Signature


An RO or ARO must manually or digitally sign and date Section 4C. If multiple pages are
needed, the RO/ARO may sign and date the last page.
Additional Information




Refresher training must be provided at least annually as well as when the entity
significantly amends its security, incident response, or biosafety plans.



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Examples for Completing the Section 4 Tables
This section is intended to provide examples on how to complete the Section 4 tables for the most
common application conditions.


Example:
o

An entity has 3 individuals who will be working directly with Tier 1 select agents or
toxins under the direct supervision of PI Smith.

The entity also has 1 individual who will be working directly with non-Tier 1 select
agents or toxins under the direct supervision of PI J. Clark.

The entity also has 2 individuals who perform support work, including maintenance
and biosafety surveys of Tier 1 laboratory areas. These individuals do not directly
work with select agents or toxins, but have the ability to gain access to Tier 1 select
agents and toxins.

Finally, the entity is requesting that two unescorted visitors be added. These two
visitors will have Tier 1 access and the Home Entity RO has submitted all required
documentation to the Host Entity, including the individuals DOJ Numbers at the Home
Entity. These individuals will be onsite for a brief training program supervised by PI
Smith lasting less than 30 days and the Home Entity RO/ARO has also submitted
documentation of the pre-access suitability assessment conducted for these
individuals.
Note: These individuals may be subject to the Host Entity’s pre-access suitability
program and will be subject to the Host Entity’s ongoing suitability assessment
program. For additional information, refer to the Guidance for Suitability Assessments
for visitors.

Section 4A - Laboratorians and Animal Care Staff

Section 4B - Support Staff

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Section 4C - Unescorted Visitors

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Section 5A - Entity-Wide Security Assessment and Incident
Response
This section is used to assess the overall security precautions and procedures in place at an entity.
Complete this section by checking either “Yes” or “No” for all questions and entering additional
information when prompted.
If the question does not apply to your entity, answer “No”.
Additional guidance is provided below; if further information or guidance is required, contact the CDC
at 404-718-2000 or APHIS at 301-851-3300 option 3.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


Question 1, Facility Type (check all that apply)


Check the classification that most accurately describes your facility. If none of the
classifications describe your facility, select “Other” and describe.

Question 2, Security Officer


If you have a security officer or other individual(s) identified to assist the RO in security
matters, check “Yes” and indicate if the security plan contains procedures for coordination
between the RO and the entity’s safety and security professionals.



If you do not have a security officer or other individual(s) identified to assist the RO in security
measures, check “No”.
Note: Tier 1 select agents and toxins require coordination between the RO and the entity’s
safety and security professionals. For additional information, refer to the Security Guidance for
Select Agent or Toxin Facilities.

Question 3, Threat Assessment


If a threat assessment has been conducted, check “Yes”.

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


If a threat assessment was not conducted, check “No”. For additional information on entity
threats, refer to the Security Guidance for Select Agent or Toxin Facilities.
If yes is indicated for b, c, and/or d, describe these incidents in the textbox provided below
question d.
Note: A threat assessment may be part of the site-specific risk assessment upon which the
security plan is designed.

Question 4, Insider risk assessment


An insider risk assessment can be conducted by any organization within the entity (Human
Resources, Security, etc.). Check all conditions which are verified prior to granting unescorted
access to select agents and toxins and check whether you have policies for self and peer
reporting as well as whether you have additional requirements for personnel suitability.
Note: Tier 1 select agents and toxins require a pre-access and ongoing suitability assessment
program, which includes provisions for self and peer reporting. For additional information, refer
to the Guidance for Suitability Assessments.

Question 5, Natural hazards


Indicate if your entity is located in any of the listed hazard zones. If you are in a hazard zone
which is not listed, check other and describe. Also indicate what actions, with respect to select
agents and toxins, will be performed in the event of a natural disaster with warning.
Note: For additional information regarding natural hazard zones, refer to the Incident
Response Plan Guidance Document.

Question 6, Electronic records and databases


If you have electronic records and databases that would allow access to select agents and/or
toxins, check “Yes”. Examples of electronic records or databases that would allow access to
select agents and/or toxins may include a) an automated access control server (key card
server) and/or a biometric access control server that controls access or b) a computer where a
combination that allows access is stored.



If yes, indicate the means to control access of the electronic records and databases by
checking all applicable characteristics.



If you do not have electronic records and databases, check “No”.
Note: For additional information regarding information security controls, refer to the
Information Systems Security Control Guidance Document.

Question 7, Shipping/Receiving


Describe the receiving area, if applicable, as well as the receipt and storage of select agent
and/or toxin shipments.
Note: Requirements for shipping and receiving will differ depending whether the entity is
employing “lost in the crowd” practices. Refer to Guidance on the Shipment and Receipt of
Packages with Select Agents and Toxins for more information about the “lost in the crowd”
policy.
Note: For additional information on select agent and toxin shipping/receiving procedures,
refer to Guidance for Completing the Shippers Declaration for Dangerous Goods and Security
Guidance for Select Agent or Toxin Facilities.

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Question 8, Transport


If select agents and/or toxins are transported within the entity and outside of the registered
area(s) (e.g., from a PI’s registered laboratory through an unregistered corridor to his/her
registered animal room for the purpose of inoculation), check “Yes”.
Note: This question does not apply to movement of select agent and/or toxin packages for
purpose of shipping and receiving.



If yes, indicate the how the security plan addresses the movement of select agent and/or toxin
material.



If select agents and/or toxins are not transported outside of the registered area(s) or are
inactivated or decontaminated prior to transport, check “No”.
Additional Information


Inventories can be controlled by individual PIs or shared. Transfers between PIs
with distinct inventories are intra-entity transfers. Movement of inventory between
PIs that share an inventory and between individuals working for the same PI are
not considered intra-entity transfers.



Entities must establish a protocol for intra-entity transfers under the supervision
of an individual with access approval from the HHS Secretary or APHIS
Administrator. Entities must establish a protocol for intra-entity transfers that
include chain-of-custody documents and provisions for safeguarding against
theft, loss, or release.



Entities that transfer quantities of select toxin(s) must ensure the amounts are
transferred only after the transferor uses due diligence and documents that the
recipient has a legitimate need (i.e., reasonably justified by a prophylactic,
protective, bona fide research, or other peaceful purpose) to handle or use such
toxins. The HHS Secretary retains the authority to, without prior notification,
inspect and copy or request the submission of the due diligence documentation
to the CDC.

Question 9, Response Time


If a response time for local law enforcement, guard force or other designated responders has
been determined, check “Yes”.



If a response time has not been determined, check “No”.
Note: For additional information on response times, refer to the Security Guidance for Select
Agent or Toxin Facilities.

Question 10, After Hours Work


If permission is required to conduct select agent and/or toxin work after established work
hours, check “Yes”.



If yes, indicate the position description or title of the individual who grants permission.



If an individual other than the RO/ARO/PI grants permission, indicate “Other” and include the
position or title of the individual (e.g., security specialist). Do not list the name(s) for any of
these individuals.

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

If permission is not required for after-hours work, check “No”.
Note: Tier 1 select agents and toxins require procedures that limit access to laboratory and
storage facilities outside of normal business hours to only those specifically approved by the
Responsible Official or designee. For additional information, refer to the Security Guidance for
Select Agent or Toxin Facilities.

APHIS/CDC Form 1 Instructions

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Section 5B - Entity-Wide Biosafety/Biocontainment
This section is used to assess the overall biosafety and biocontainment precautions and procedures
in place at an entity. Complete this section by checking either “Yes” or “No” for all questions and
entering additional information when prompted.
If the question does not apply to your entity, answer “No”.
Additional guidance is provided below; if further information or guidance is required, contact the CDC
at 404-718-2000 or APHIS at 301-851-3300 option 3.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


Question 1, Biosafety Program



Briefly describe the biosafety program that develops and implements the biosafety and
biocontainment procedures described in the site-specific biosafety plan (e.g., Environmental
Health & Safety Office, Institutional Biosafety Committee (IBC), etc.).
If an independent biosafety program is not in place at the entity, describe the biosafety
expertise that is used to develop and implement the biosafety plan for work with the select
agents and/or toxins (e.g., consultation with a biosafety professional, subject matter expert or
the IBC as recommended for biological risk assessments in the BMBL.

Question 2, Proficiency


If laboratory personnel must demonstrate proficiency in standard and special microbiological
practices and laboratory procedures prior to working with the select agent and/or toxin, check
“Yes”.



If laboratory personnel do not demonstrate proficiency in these practices and procedures prior
to working with the select agent and/or toxin, check “No”.

APHIS/CDC Form 1 Instructions

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Question 3, Personal Protective Equipment


If appropriate personal protective equipment is required for the select agent and/or toxin and
the work performed, check “Yes”.



If PPE is not required based on biological risk assessment and in accordance with BMBL,
check “No”.

Question 4, Occupational Health (Tier 1)


If individuals with access to Tier 1 select agent and/or toxin are enrolled in an occupational
health program (e.g., collection/storage of serum samples; available immunizations offered to
at-risk personnel; or a system for reporting and documenting laboratory accidents, exposures
and medical surveillance of potential Laboratory Associated Infections), check “Yes”.



If individuals with access to Tier 1 select agent and/or toxin are not enrolled in an occupational
health program, check “No”.
Note: Individuals with access to Tier 1 select agents and toxins must be enrolled in the
occupational health program. For additional information on Tier 1 select agents and toxins
occupational health programs, refer to the Occupational Health Program Guidance Document
for Working with Tier 1 Select Agents or Toxins.

Question 5, Occupational Health (Non-Tier 1)


If individuals with access to non-Tier 1 select agents and/or toxins are enrolled in an
occupational health program (e.g., collection/storage of serum samples; available
immunizations offered to at-risk personnel; or a system for reporting and documenting
laboratory accidents, exposures and medical surveillance of potential Laboratory Associated
Infections), check “Yes”.



If individuals with access to non-Tier 1 select agents and/or toxins are not enrolled in an
occupational health program, check “No”.
Note: The FSAP requires immediate notification and a report within 7 days on APHIS/CDC
Form 3 upon the discovery of a release of a select agent or toxin causing occupational
exposure or release of a select agent or toxin outside of the primary barriers of the
biocontainment area. Further, BSL3 safety standards described in the current edition of the
BMBL state "laboratory personnel must be provided medical surveillance and offered
appropriate immunizations for agents handled or potentially present in the laboratory”. It is
recommended that entities enroll individuals in occupational health programs for use and/or
storage of non-Tier 1 select agents and toxins.

Question 6, Sharps


If policies for the safe handling of sharps (e.g., glass slides/pipets, needles, scissors, scalpels,
glass vials/columns) are in place and developed in accordance with BMBL, check “Yes”.



If sharps are not used or there is no policy in place concerning the safe handling of sharps,
check “No”.

Question 7, Spill Protocol


If there is a spill protocol in place, appropriate to the select agent and/or toxin work, and
developed in accordance with BMBL, check “Yes”.



If there is no spill protocol in place, check “No”.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

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Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Question 8, Pest Management


If an integrated pest management program developed in accordance with BMBL and relevant
local, state and federal guidelines is in place, check “Yes”.



If an integrated pest management program is not in place, check “No”.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Section 5C - Entry Requirements for Federal Select Agent
Program Inspectors
This section is used to collect the entry requirements in place at each entity for FSAP Inspectors to
conduct site visits of new and registered laboratories. Take into account all registered suites/rooms
when completing this section, including any additional entry requirements considered when active
work with select agents and/or toxins is conducted. Complete this section by checking either “Yes” or
“No” for all questions and entering additional information when prompted.
If the question does not apply to your entity, answer “No”.
Additional guidance is provided below; if further information or guidance is required, contact the CDC
at 404-718-2000 or APHIS at 301-851-3300 option 3.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


Question 1, Entry to the Facility


Describe the procedure inspectors will use to gain entry to the facility. Include parking
instructions.

Question 2, Identification


Indicate the type of identification that Federal Select Agent Inspectors should present to verify
their identity.
Note: Inspectors will only present federally issued credentials. This identification will not be
surrendered to the entity. For additional information, see Verifying Inspectors and
Confidentially Agreement Policy.

Question 3, Security


If verification of security information is required between the Federal Select Agent Inspectors
and an entity official, such as a Visitor Authorization Letter, check “Yes”.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

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Federal Select Agent Program website
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

If there are no security clearance requirements, check “No”.



If the entity has a process to collect security information in advance of the inspection, check
“Yes”. Describe what and how this should be managed. Examples of this may be a form to be
filled out or an online login to enter information.

Question 4, Respirator


If respiratory protection is required to enter registered suites/rooms, check “Yes”.



If yes, indicate what types of respirators are required; if a Powered Air Purifying Respirator
(PAPR) is required, indicate if it will be provided to FSAP Inspectors by the entity.



If respiratory protection is not required to enter registered rooms/suites, check “No”.

Question 5, Personal Protective Equipment (PPE)


List all other PPE required to enter laboratory or animal areas. Indicate if the listed PPE will be
provided to FSAP inspectors by the entity.

Question 6, Medical Documentation


If medical documentation is required to enter registered suites/rooms, check “Yes” and
proceed to the additional questions. If no medical documentation is required, check “No” and
proceed to the next question.



Indicate whether there are immunization requirements to enter a laboratory. If yes, specify the
immunization entry requirement(s) to enter a laboratory as well as whether it is required or
recommended.



Indicate whether a PPD (Tuberculin skin test) is required for entry into animal or laboratory
areas as well as the required interval.



If documentation is not required to enter laboratories, check “No”.

Question 7, Entity-specific training


Indicate any onsite training which is required before entry into a laboratory.



If the training can be taken in advance, describe the details.

Question 8, Additional entry requirements


If there are additional entry procedures not addressed by the above questions, provide this
information here.

Note: CDC and APHIS are authorized to conduct announced or unannounced inspections per section
18 of the Select Agent Regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331).
Inspectors may conduct inspections without notification and while FSAP inspectors will make an effort
to comply with entity entry policies, unreasonable entry requirements that result in considerable
delays to the inspection process may be subject to administrative review and/or compliance actions.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Section 6A - Building and Suite/Room Specific Security
This section is used to assess building and suite/room specific security at an entity. Complete for each
suite and room to be registered. Complete this section by checking either “Yes” or “No” for all
questions and entering additional information when prompted.
If the question does not apply to your entity, answer “No”.
Additional guidance is provided below; if further information or guidance is required, please contact
the CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.
Note: A corresponding Section 6B will be required for each Section 6A with a unique room and/or
suite identified in the header.
Note: A complete Section 6 must be submitted for each unique room and/or suite. If a series of
rooms and/or suites would result in an identical Section 6 being completed, multiple rooms and/or
suites may be listed in the header.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


Enter the date that the document is being submitted to APHIS/CDC in the following format
mm/dd/yyyy.
Note: The above header information must be consistent for all sections and attachments
submitted at one time.

Building/Suite or Room:


Fill out the Building and Suite/Room which is to be registered for select agents and/or toxins.

Question 1, Tier 1 Use


If the suite/room is to be used for Tier 1 select agents and/or toxins, check “Yes”.



If the suite/room will not be used for Tier 1 select agents and/or toxins, check “No”.
Note: Tier 1 select agent and toxin registered areas require, at a minimum, three barriers
where each subsequent barrier adds to the delay in reaching secured areas where Tier 1
select agents and toxins are used or stored. For additional information, refer to the Security
Guidance for Select Agent or Toxin Facilities.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
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Question 2, Perimeter Security Measures


Indicate the perimeter security measures which are in place outside of the building. Each
respective security measure should be checked even if they are not dedicated to the select
agent program or are ‘incidental’ based on the entity locations.



If you have additional security measures not specified, check “Other” and describe.
Note: For additional information on security measures and physical security barriers, refer to
the Security Guidance for Select Agent or Toxin Facilities.
Note: An exterior intrusion detection systems consists of an intrusion detection system
associated with the perimeter of a facility, not the structure/building that houses the registered
space. These are generally outdoor sensors, common types include: sensors employed along
a perimeter fence, microwave sensors employed in a Clear Zone between fences, buried
sensors in Clear Zone between fences.

Question 3, Building Access


Indicate which methods are used to control access to the building which houses the
suite/room.



If you have additional access controls not specified, check “Other” and describe.

Question 4, Interior Security Measures


Indicate all additional measures from the outside of the building to the suite/room where the
agent or toxin is stored.



Video surveillance is an optional security measure many entities choose to employ. It can be
dedicated monitoring or a “rolling screen” among several/many camera views, and may be for
safety or security reasons. Monitoring involves live, active viewing of video surveillance by
individuals, such as security personnel, whereas the review of video recordings can happen at
any time and typically is a replay to provide a retrospective view. The responsibility for
monitoring laboratory live video should lie with individuals who are capable of responding to a
laboratory emergency or can relay the situation to the appropriate emergency response
personnel. The responsibility to review video recordings should lie with individuals who are
familiar with work practices in the laboratory and can assess whether work is being performed
in a safe manner (i.e. PI, laboratorians, RO).



If you have other security measures not specified, check “Other” and describe.

Question 5, Access to Suite/room


Indicate which methods are used to control access to the suite/room.



If you have additional access controls not specified, check “Other” and describe.

Question 6, Access to Storage Units


Indicate which methods are used to control access to storage unit(s).



If you have additional access controls not specified, check “Other” and describe.

Question 7, Pass-Through Autoclave


If there is a pass-through autoclave in the suite/room, check “Yes”.

APHIS/CDC Form 1 Instructions

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Federal Select Agent Program website
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

If yes, indicate whether the doors are interlocked.



If there is no pass through autoclave in the suite/room, check “No”.

Question 8, Autoclave Outside of Suite/Room


If there is an autoclave outside of the suite/room used for decontamination of select agent
and/or toxin waste, check “Yes”.



If yes, indicate the distance from the suite/room to the autoclave.



If this question does not apply, check “No”.

Question 9, Pass-Through Window or Box


If there is a pass-through window or box at the perimeter of the suite/room, check “Yes”.



If yes, indicate whether or not it is secured.



If there is not a pass through window or box, check “No”.

Question 10, Dunk Tank


If there is a dunk tank at the perimeter of the suite/room, check “Yes”.



If yes, indicate whether or not it is secured.



If there is not a dunk tank, check “No”.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Section 6B - Suite/Room Physical Information
This section is used to assess the physical information for each suite and/or room at an entity.
Multiple, complete Section 6’s may need to be submitted depending on the number of rooms and/or
suites at an entity. Complete this section by checking either “Yes” or “No” for all questions and
entering additional information when prompted.
If the question does not apply to your entity, answer “No”.
Additional guidance is provided below; if further information or guidance is required, please contact
the CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.
Note: A complete Section 6 must be submitted for each unique suite and/or room. If a series of
rooms and/or suites would result in an identical Section 6 being completed, multiple rooms and/or
suites can be listed in the header.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


Building/Suite or Room


Fill out the Building and Suite/Room which is to be registered for select agents and/or toxins.

Floor Plans


Provide a floor plan for each suite and/or room to be registered.



The 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)], Heating
Ventilation and Air Conditioning (HVAC) supply and exhaust vents, and cage washing area.
Note: A separate floor plan showing the suite/room in relation to the building and/or a
separate floor plan specifying airflow may also be requested.

APHIS/CDC Form 1 Instructions

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When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
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Note: For a suite/room used for storage only, provide the first page of Section 6B with the
header completed and floor plan. Proceed to Section 7.

Question 1, Biological Safety Level


Indicate the biological safety level(s) at which the laboratory is operated. If the laboratory is
operated at more than one safety level (e.g., BSL3 and ABSL3) or if the laboratory can
operate at different containment levels and the safety level changes based on usage (e.g.,
ABSL3 and ABSL4), indicate all applicable safety levels.



Biological Safety Levels
Biosafety Levels
Biosafety Level 2 = BSL2
Biosafety Level 3 = BSL3
Biosafety Level 4 = BSL4
Animal Biosafety Levels
Animal Biosafety Level 2 = ABSL2
Animal Biosafety Level 3 = ABL3
Biosafety Level 3 Agriculture = BSL3Ag
Animal Biosafety Level 4 = ABSL4
Recombinant DNA (rDNA) Biosafety Levels
rDNA BSL2 = NIHBL2
rDNA BSL3 = NIHBL3
rDNA BSL4 = NIHBL4
rDNA Large Animal BSL2 = NIHBL2N
rDNA Large Animal BSL3 = NIHBL3N
rDNA Large Animal BSL4 = NIHBL4N
rDNA Large Scale BSL2 = NIHBL2-LS
rDNA Large Scale BSL3 = NIHBL3-LS
rDNA Large Scale BSL4 = NIHBL4-LS
Arthropod Biosafety Levels
Arthropod BSL 3 = ACL3
Arthropod BSL4 = ACL4

Note: The entity’s biosafety or biocontainment plan must define the operational and
procedural safeguards that are implemented prior to operating a suite/room at different
containment levels when the safety level changes based on usage.
Note: Rooms within a suite should be included together in one Section 6 provided that the
rooms operate as a unit at the same containment level.


List the references and/or resources used to determine the biological safety level of the suite
or room.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Note: Safety levels should be determined in accordance with guidance found in the current
edition of the BMBL.
Note: Regardless of the funding source, an NIH biosafety level should be indicated for
research involving the handling and/or construction of 1) nucleic acids that can produce
recombinant infectious forms of any select agent virus, 2) recombinant and/or synthetic nucleic
acids that encode for functional form(s) of any select toxin if the nucleic acids can be
expressed in vivo or in vitro, or are in a vector or recombinant host genome and can be
expressed in vivo or in vitro, 3) select agents whose genomes have been modified by
recombinant/synthetic methods (e.g., genomic deletions or insertions, the introduction of
plasmids), or 4) RNA isolated from positive (+) stranded select agent viruses that have been
genetically modified by recombinant/synthetic methods. For more information please see the
NIH Guidelines for Research Involving Recombinant DNA Molecules.
Note: No provisions are made for work at NIHBL4-LS in the Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid Molecules. Requirements will be established by NIH
on an individual basis.

Question 2, BSC and Fume Hood


If biosafety cabinets (BSCs) and fume hoods are certified at least annually and records are
kept for at least 3 years, check “Yes”.



If BSC and fume hoods are not certified at least annually or do not have records kept for at
least three years, check “No”.

Question 3, Sink


If a sink is present in the laboratory for hand washing, check “Yes”.



If yes, indicate if the sink is hands-free or automatically operated.



If there is no sink present in the laboratory for hand washing, check “No”.

Question 4, Eyewash


If an eyewash station is readily available, check “Yes”.



If an eyewash station is not readily available, check “No”.

Question 5, Liquid Effluent


If liquid effluents originating from the laboratory are collected and treated for sterility prior to
exiting the facility or entering a public sewage system, check “Yes”.



If yes, indicate whether effluent from the containment shower areas are similarly treated and if
the effluent decontamination is validated monthly.




Note: Please reference Appendix Q of the NIH Guidelines for Research Involving
Recombinant or Synthetic Nucleic Molecules (NIH Guidelines) for guidance as to when
monthly validation of the effluent decontamination system is required.

If liquid effluents originating from the laboratory are not collected and treated, check “No”.
Note: Liquid effluent decontamination is an enhancement required in maximum containment
facilities performing work at BSL4, ABSL4, and BSL3Ag and for propagative work with highly
transmissible and pathogenic agents such as but not limited to highly pathogenic avian
influenza virus, Classical swine fever virus, and Foot-and-mouth disease virus.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Note: If you have questions about liquid effluents, please see “effluents” in the Definitions
section.
Note: If BSL3Ag, BSL4, or ABSL4 is selected as the biosafety level the laboratory is operated
at, proceed to Section 7.

Question 6, Access doors


If access to the suite/room is through two self-closing doors, check “Yes”.



If yes, indicate if the doors from the anteroom open inward to the laboratory.



If access is not through two self-closing doors, check “No”.

Question 7, Directional airflow


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



If the ventilation system does not provide sustained directional airflow, check “No”.

Question 8, No Reversal of Airflow


If the laboratory is designed such that under failure conditions the airflow will not be reversed
outside the containment barrier, check “Yes”.



If the laboratory is not designed to prevent reversal of airflow outside the containment barrier
under failure conditions, check “No”.
Note: Refer to SelectAgents.gov and Containment Facility Design and Construction
(Secondary Barriers) for additional information regarding reversal of airflow.

Question 9, Verification


If laboratory design and operational parameters are re-verified at least annually, check “Yes”.



If laboratory design and operational parameters are not re-verified at least annually, check
“No”.
Note: Refer to SelectAgents.gov and Containment Facility Design and Construction
(Secondary Barriers) for additional information regarding annual facility re-verification.

Question 10, Monitoring


If a visual monitoring device, which confirms directional airflow, is provided at the laboratory
entry, check “Yes”.



If there is no visual monitoring device, check “No”.

Question 11, Exhaust


If laboratory exhaust is not re-circulated to other areas of the building, check “Yes”.



If laboratory exhaust is re-circulated, check “No”.

Question 12, HEPA Filtering


If room exhaust air leaving the laboratory is HEPA filtered, check “Yes”.



If yes, indicate whether the HEPA filter housing has decontamination or test ports and is
certified at least annually.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.



If the laboratory is a suite, record the specific rooms that have HEPA filtered exhaust or record
“All” if all rooms in the suite are HEPA filtered.



If the exhaust air leaving the laboratory is not HEPA filtered, check “No”.



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

Question 13, Emergency Shower


If an emergency shower is readily available, check “Yes”.



If an emergency shower is not readily available, check “No”.

Question 14, Floor Drains


If floor drains are present, check “Yes”.



If floor drains are not present, check “No”.

Question 15, Sink Traps and Floor Drains


If sink traps and floor drains are filled with water and/or appropriate liquid to prevent the
migration of vermin and gases, check “Yes”.



If sink traps and floor drains are not filled with water and/or appropriate liquid, check “No”.

Question 16, Mechanical Cage Washer


If a mechanical cage washer is present within the facility, check “Yes”.



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



If a mechanical cage washer is not present, check “No”.

Question 17, Shower Out


If the laboratory is designed with a shower and change room to permit personal showers when
exiting the containment area, check “Yes”.



If there is not a shower-out capability, check “No”.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Section 7A - Principal Investigator Information and Select Agent
and Toxin Locations
This section captures select agents and toxins, suites/rooms, and specific work performed by a
Principal Investigator. Multiple, complete Section 7s may need to be submitted depending on the
number of Principal Investigators at an entity. Complete this section by checking either “Yes” or “No”
for all questions and entering additional information when prompted.
If the question does not apply to your entity, answer “No”.
Additional guidance is provided below; if further information or guidance is required, please contact
the CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.
Note: A complete Section 7 must be submitted for each PI. If multiple PIs conduct identical work with
select agents and toxins, complete one Section 7 and list all of the relevant PIs in the header.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


Principal Investigator
Refer to the definition below when specifying a Principal Investigator:


Principal Investigator (PI) – the individual who is designated by the entity to direct a project
or program and who is responsible to the entity for the scientific and technical direction of that
project or program.

PI Name


Provide the individual's first name and last name or surname, without use of nicknames.

PI DOJ Number


APHIS/CDC Form 1 Instructions

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PI Date of Birth


Enter the date of birth in the following format: mm/dd/yyyy.

PI Tier 1 Access


Check box if PI will have access to Tier 1 select agents or toxins.
Note: Individuals that have access or have the ability to access Tier 1 select agents and toxins
require additional personnel security procedures. Refer to the Guidance for Suitability
Assessments for additional information on pre-access suitability and ongoing suitability
assessments for visitors.

Update PI Header button
If entering information into a complete Section 7 (inclusive of Section 7A, 7B, and 7C) or into Section
7A which grows onto a second page, the Update PI Header button must be used to populate the PI
name(s) in the header of all subsequent pages.

Section 7A Table
This table lists those select agents/toxins which will be under the direct control of the PI listed in the
Section 7 header. Additionally, the laboratory locations (including safety levels) and storage locations
should be listed for each select agent/toxin.

Select Agent/Toxin/Regulated Nucleic Acid


An entity must list at least one select agent or toxin in order to be registered with the FSAP.



List only one select agent, toxin, or regulated nucleic acid per row.



Do not list any biological agents or toxins that are not on the current, approved Select
Agent/Toxin List. If you possess an agent or toxin that you believe should be included in
Section 7A but is not on the list, consult with your designated FSAP representative or contact
the CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.



Do not abbreviate the name of a select agent or toxin. Enter select agents or toxins exactly as
they appear on the current, approved Select Agent/Toxin List.



Enter regulated nucleic acids exactly as they appear below:
HHS Select Agent and Toxin Regulated Nucleic Acids
Genomic material – Eastern Equine Encephalitis virus
Genomic material – Kyasanur Forest disease virus
Genomic material – Omsk Hemorrhagic Fever virus
Genomic material – SARS–associated coronavirus
Genomic material – Tick-borne encephalitis virus, Far Eastern subtype
Genomic material – Tick-borne encephalitis virus, Siberian subtype
Recombinant/synthetic nucleic acids encoding Abrin
Recombinant/synthetic nucleic acids encoding Botulinum neurotoxin
Recombinant/synthetic nucleic acids encoding Conotoxins
Recombinant/synthetic nucleic acids encoding Ricin
Recombinant/synthetic nucleic acids encoding Staphylococcal enterotoxin
Overlap Select Agent Regulated Nucleic Acids

APHIS/CDC Form 1 Instructions

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HHS Select Agent and Toxin Regulated Nucleic Acids
Genomic material – Venezuelan Equine Encephalitis virus
USDA Veterinary Services (VS) Select Agent Regulated Nucleic Acids
Genomic material – Classical Swine Fever virus
Genomic material – Foot-And-Mouth Disease virus
Genomic material – Swine Vesicular Disease virus

Location


Enter the building and suite/room for each area to be registered.
Note: Multiple rooms may be listed in the same row if:
o
o

They have the same laboratory or storage designation (ex. Lab, Storage or Both) and,
They have the same safety level(s).

Laboratory or Storage


Check appropriate box(es) to specify whether the location is a laboratory, a storage area, or
both.
o

Any building and suite/room where work with select agents and/or toxins is performed
should be designated as a laboratory.

Any building and suite/room that will only be used for storage and not active work with
select agents and/or toxins should be designated as storage only.
Note: Decontamination/destruction suite/rooms may not need to be registered.
Registration is specific to circumstances at the entity. For example, if the entity will need to
temporarily store waste, other infectious select agent material, or active toxin material in
this area, the room will need to be registered. Consult with your designated FSAP
representative or contact the CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.

Laboratory Safety Level


Enter the safety level for the location. If multiple safety levels apply (e.g., BSL3, NIHBL3,
ABSL3), indicate all safety levels.



It is acceptable to enter additional laboratory safety levels on a single row providing that the
containment level number is the same (e.g., BSL3/ABSL3/NIHBL3, or BSL2/ABSL2).
o

For example, a single laboratory suite or room may operate at BSL3 for propagation of a
select agent, NIHBL3 for recombinant DNA work performed using a select agent, and
ABSL3 for select agent animal studies where inoculated animals are housed in the
laboratory.



If the area is storage only, leave this column blank.



If a room is designated as a laboratory and a storage area, enter the safety level for the
laboratory only.



Biological Safety Levels
Biosafety Levels
Biosafety Level 2 = BSL2
Biosafety Level 3 = BSL3
Biosafety Level 4 = BSL4

APHIS/CDC Form 1 Instructions

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Biosafety Levels
Animal Biosafety Levels
Animal Biosafety Level 2 = ABSL2
Animal Biosafety Level 3 = ABL3
Biosafety Level 3 Agriculture = BSL3Ag
Animal Biosafety Level 4 = ABSL4
Recombinant DNA (rDNA) Biosafety Levels
rDNA BSL2 = NIHBL2
rDNA BSL3 = NIHBL3
rDNA BSL4 = NIHBL4
rDNA Large Animal BSL2 = NIHBL2N
rDNA Large Animal BSL3 = NIHBL3N
rDNA Large Animal BSL4 = NIHBL4N
rDNA Large Scale BSL2 = NIHBL2-LS
rDNA Large Scale BSL3 = NIHBL3-LS
rDNA Large Scale BSL4 = NIHBL4-LS
Arthropod Biosafety Levels
Arthropod BSL 3 = ACL3
Arthropod BSL4 = ACL4

Note: The selected laboratory safety level for each laboratory area should be consistent with
the containment recommendations in the current edition of the BMBL for each select agent
and toxin.
Note: The selected laboratory safety level for each laboratory area used for the manipulation
of regulated nucleic acids should be indicated. The safety level should be consistent with the
work performed (e.g., NIHBL2 for manipulation of recombinant DNA in a BSL2 laboratory) and
with the Laboratory Facilities (Secondary Barriers) standards in the current edition of the
BMBL for each laboratory area.
Note: Regardless of the funding source, an NIH biosafety level should be indicated for
research involving the handling and/or construction of 1) nucleic acids that can produce
recombinant infectious forms of any select agent virus, 2) recombinant and/or synthetic nucleic
acids that encode for functional form(s) of any select toxin if the nucleic acids can be
expressed in vivo or in vitro, or are in a vector or recombinant host genome and can be
expressed in vivo or in vitro, 3) select agents whose genomes have been modified by
recombinant/synthetic methods (e.g., genomic deletions or insertions, the introduction of
plasmids), or 4) RNA isolated from positive (+) stranded select agent viruses that have been
genetically modified by recombinant/synthetic methods. For more information please see the
NIH Guidelines for Research Involving Recombinant DNA Molecules.

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Suite Legend


If suites are designated in the location column, identify the suite name at the bottom of the
page in the space provided and indicate all individual room designations which comprise the
suite.
Note: Designating a series of connected rooms or continuous areas as a suite may require an
additional review and approval. Contact the CDC at 404-718-2000 or APHIS at 301-851-3300
option 3 to determine whether your initial application should list each individual room or
consolidate them into a single suite.

Examples for Completing the Section 7A Table
Example 1: An entity wishes to work with two select agents, Bacillus anthracis and Yersinia pestis in
Building 1. Work with both agents will be conducted by PI Smith in Room 100 at BSL3 and both
agents will only be stored in Room 103.

Note: If a room is designated as a storage room only, leave the Laboratory Safety Level column
blank.

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Example 2: An entity wishes to work with one select agent, avian influenza virus in building XYZ.
Work with avian influenza virus will be conducted by PI Anderson in Suite 800, which is comprised of
Rooms 800, 801 and 802. The entity will also perform recombinant work with avian influenza virus.
The safety level of the suite is BSL3 and all rooms in the suite will also be used for storage.

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Example 3: An entity wishes to work with two select agents, Brucella abortus and Yersinia pestis in
Building 1. Work with both agents will be conducted by PI Jones in Rooms 100, 200, 300, 400 and
500 at BSL3. Laboratory Room 500 will also serve as the only storage room for both agents.

Note: Multiple rooms may be listed for the same agent if:


They have the same laboratory or storage designation (ex. Lab, Storage or Both) and,



They have the same safety level.

Note: If a room is designated as a laboratory and a storage room, enter the safety level for the
laboratory only.

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Example 4: An entity will perform clinical diagnostic work using Bacillus anthracis Pasteur strain,
excluded strains only of Francisella tularensis, Yersinia pestis, and ricin A-chain. This entity will
transfer or destroy any samples confirmed as select agents or toxins within seven days of
identification.

Example 5: An entity has two PI’s performing the same work with SARS-CoV. Drs. Werner and Sun
propagate SARS-CoV virus, modify viral genes and test pathogenesis of these recombinant viruses in
the natural host.

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Example 6: An entity is requesting to produce regulated quantities of botulinum neurotoxin using a
recombinant construct encoding the functional toxin in Building C. Within Building C, Room 301 will be
operated at BSL2 for work with botulinum neurotoxin and manipulation of a recombinant nucleic acids
encoding botulinum neurotoxin under the direction of PI Jane Smith. Both botulinum neurotoxin and
the recombinant nucleic acids encoding botulinum neurotoxin will be stored in Room 303 in a locked
freezer.

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Section 7B - Strain or Serotype Designation Information
This section is used to list the inventory’s strain or serotype designations for the Principal Investigator
indicated in the header. This section can be completed using either the pdf or excel version found at
http://www.selectagents.gov/form1.html.
If further information or guidance is required contact the CDC at 404-718-2000 or APHIS at 301-8513300 option 3.

Header Information (if completing a stand-alone Section 7B only)
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


PI


Fill out the name of the Principal Investigator(s) for which the Section 7 is being completed.
Use first initial followed by last name, separate multiple PI names with commas.

Select Agent/Toxin


List only one select agent, toxin or regulated nucleic acid per row.



Enter select agents or toxins exactly as they appear on the current, approved Select
Agent/Toxin List. Do not abbreviate.



Do not list any biological agents or toxins that are not on the current, approved Select
Agent/Toxin List

Strain or Serotype Designations


For new applications, list “TBA” (To Be Acquired) for each select agent, toxin or regulated
nucleic acid.

Once your entity is registered, complete the table as follows:
 List only one strain or serotype per row.

APHIS/CDC Form 1 Instructions

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

List the strain or serotype designation(s) for all select agents and toxins listed in Section 7A
only if known, or “TBD” (To Be Determined) if strains of the agent are defined and used
scientifically, but are unknown to the entity (e.g., diagnostic samples that were not identified to
the strain level).



If you do not yet possess the select agent, toxin, or regulated nucleic acid but intend to acquire
it in the future, indicate “TBA” (To Be Acquired) as the strain designation.



Do not list strains excluded from the Select Agent Regulations.



A strain or serotype is defined, for the purposes of the APHIS/CDC Form 1, as a group of
organisms of the same species, sharing certain hereditary characteristics not typical of the
entire species but minor enough not to warrant classification as a separate breed or variety
(e.g., Ames strain of Bacillus anthracis). For agents that have been genetically modified due to
passage in vivo or in vitro and have become differentiated from the parental organism, the
modified agent or toxin should be recorded as a separate strain on the strain table (examples
may include: extended in vitro passage under increasing concentrations of one or more
antimicrobials in order to generate a desired enhanced resistance profile; in vivo passage of
an attenuated strain to select for the restoration of virulence). Additional guidance is provided
below for select agent strain designations and toxin types, but may not be all inclusive of
“unique” select agent strains or toxin types an entity may possess.



For select bacterial/fungal agents, if a unique phenotypic or genotypic marker is purposely
enriched/selected for or introduced to differentiate progeny from the parent organism then this
needs to be recorded as a “unique” strain on the strain table.



Select agents resistant to specific antimicrobials should be designated using generally
accepted nomenclature (e.g., Y.p. xyzK237A CmR), if characterized. Additional information
for the introduction of antimicrobial resistance must be provided regarding these
experiments in Attachment B.

For agents that have been genetically modified due to the introduction of foreign genes
(whether integrating into the chromosome or maintained exogenously) or the modification
or deletion of genetic elements, the modified strain should be recorded as a separate strain
on the strain table. Recombinant select agents should designated using generally
accepted nomenclature (e.g., B.ps.∆xyz::zeo ∆abc::kan; B.m. ∆xyz::zeo (pBHR2abc::kan)).
Additional information regarding these experiments should be described in Attachment B.

For select agent viruses, if a unique phenotypic/genotypic marker is purposely used to
differentiate a virus from the parent strain then this needs to be recorded as a “unique” strain
on the strain table.
o

For genomic material of select agent viruses, indicate the parent strain used for viral
nucleic acid extraction.

Select viruses resistant to specific antivirals should be designated using generally
accepted nomenclature, if characterized. Additional information for the introduction of
antiviral resistance must be provided regarding these experiments in Attachment B.

Recombinant and/or synthetic nucleic acids capable of producing infectious form(s) of
select agent viruses should be designated in the strain table. Special emphasis should be
given to recombinant constructs containing select agent genes that (a) can generate a live,
infectious virus [including chimeras] and (b) could produce a virus with increased
pathogenic potential when compared to the parent virus. Additional information regarding
these experiments should be described in Attachment B.

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Note: Chimeric viruses whose genomes contain the backbone and replication machinery
of a select agent virus or contain genes from different select agent viruses are regulated.
Regulated chimeric viruses have to be evaluated on a case-by-case basis to determine if
the viruses exhibit sufficient attenuation to be excluded. Chimeras that are comprised of
select agent and non-select agent genes from the same virus family require careful review
to determine select agent status. It is the entity’s responsibility to determine if the resultant
chimera is a select agent; however, the FSAP encourages entities to submit these types of
chimeras for review.


For select toxins, indicate the serotype and subtype of each toxin (e.g., botulinum
neurotoxin, BoNT/A1). If a “unique” phenotypic/genotypic marker is used to purposely
differentiate toxin types, then this needs to be recorded as a “unique” subtype on the strain
table.
o

For recombinant and/or synthetic nucleic acids that encode for the functional
form(s) of 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, record the gene(s) that encode for the functional form(s) of
the select toxin (e.g., BoNTA-LC+Belt). Any genetic modifications of the toxin
gene(s) should also be indicated.

Additional information regarding the deliberate formation of recombinant and/or
synthetic DNA containing genes for the biosynthesis of select toxins or subunits
of those toxins must be described in Attachment B.



Genetic modification of select agents or toxins should be designated in the strain table and
described in Attachment B. For the purposes of APHIS/CDC Form 1, a distinct set of genetic
modifications may be defined as a group of genetic mutations that (a) were generated using a
common technique (e.g., in a single set of related experiments) and (b) are expected to
encode gene products with a similar set of pathogenic characteristics. For example, a set of
mutants could be entered in the strain table with a single entry stating “randomly-generated
transposon mutants of Bacillus anthracis Ames for vaccine development”, “50bp overlapping
deletion mutants of Botulinum toxin A1 for use in pathogenesis studies”, “mutants generated
by DNA shuffling of the protective antigen (PA) of Bacillus anthracis (Ames) for vaccine
development”, “mutants of EEE (NJ-60) that remove the non-structural genes to generate a
replicon containing only the structural genes and a reporter gene”, or “the 5’ (structural) genes
of VEE (V3000) with the 3’ (non-structural) genes of Sindbis, rearranged to test for attenuation
and gene-order effects”. Targeted mutagenesis where the characteristic is known should be
designated separately as unique strains or serotypes.



As defined in section 3(c) and section 4(c) of the Select Agent Regulations (42 CFR Part 73, 9
CFR Part 121, and 7 CFR Part 331), regulated select agent viral nucleic acids, recombinant
and/or synthetic nucleic acids encoding select toxins, and genetically modified select agents
should be indicated in Attachment B and include explanatory information regarding these
experiments. Sufficient information should be included such that the FSAP can evaluate the
safety and security considerations associated with recombinant and/or synthetic nucleic acids
or genetic modification of select agents and toxins. Summarize any virulence testing that may
have been completed on the described modifications, or state that they are uncharacterized.



Updated strain information should be: 1) maintained on a real time basis; 2) submitted
quarterly if strain related changes in your entity’s inventory occur; or 3) submitted
annually if no strain related changes have occurred in your entity’s inventory since
your last submission.

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Note: At any time the FSAP may request an accurate listing of all select agent and toxin
strains possessed by your entity. One document containing the strain information for your
entity’s complete inventory or individual documents listing the strain information for each PI’s
inventory may be submitted.

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Example for Completing the Section 7B Table
Following FSAP approval, PI Jones acquires strains for the following select agents and toxins.

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Section 7C - Description of Work
This section captures information about the work each Principal Investigator performs. Complete this
section by checking either “Yes” or “No” for all questions and entering additional information when
prompted.
If the question does not apply to your entity, answer “No”.
Attachments A-G may need to be completed depending on the work performed.

Header Information (if completing a stand-alone Section 7C only)
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


PI


Fill out the name of the Principal Investigator(s) for which the Section 7 is being completed.
Use first initial followed by last name, separate multiple PI names with commas.

Question 1, Objective of Work


For each select agent and/or toxin listed in Section 7A, indicate the biosafety level and
objective of work. Multiple select agents and/or toxins may be listed together if the biosafety
level and objective of work are the same.



The objective of work should include a description of the methodologies and laboratory
procedures. The statement should indicate any in vitro and/or in vivo assays used for
research, any aerosolization protocols involving select agents and toxins, and/or identification
of the select agents/functional toxins listed in Section 7A.



The statement should be tailored to primarily include information or specific aims for the work
expected to be conducted within the 3 year approval period.



If no work is being performed with a select agent, then indicate “storage only”.



It is acceptable to enter additional laboratory safety levels on a single row providing that the
containment level number is the same (e.g., BSL3/ABSL3/NIHBL3, or BSL2/ABSL2).

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Example for Completing the Section 7C Table
PI is performing diagnostic work with Brucella species at BSL2 and research at BSL3.

Note: The objectives of work above are regulated under Section 4(c)(3). The antibiotics in this
example, ampicillin and kanamycin are not used to control Brucella abortus, Brucella melitensis, or
Brucella suis in humans or veterinary medicine. Therefore, this work would not meet the definition of
a restricted experiment under Section 13 as long as the method used to confer resistance to
kanamycin does not also confer cross resistance to gentamicin. If the introduction of kanamycin
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resistance does confer resistance to gentamicin, this aspect of the work would meet the definition of a
restricted experiment. Genetic modifications would be described in Attachment B. Consult with your
designated FSAP representative or contact the CDC at 404-718-2000 or APHIS at 301-851-3300
option 3 for further information.

Question 2, Maximum Quantity/Concentration of Select Agent


For each select agent listed in Section 7A, estimate the maximum quantity and concentration
grown at a given time. The maximum quantity can be given, for example, in units of petri
dishes or total volume and concentration of liquid media (e.g., 2-250ml flasks of 105 cfu/ml). If
select agents will not be propagated, then indicate “no propagation of agent.”
Notes: a) The term propagation refers to sub-culturing or the culturing of the select agent to
obtain additional select agent for diagnostic, research, or archival purposes.
b) A maximum quantity for all select agents listed in Section 7A for each PI must be
provided.
c) A maximum quantity/concentration is NOT required for regulated nucleic acids. If
Section 7A includes regulated nucleic acids, indicate if these materials are held in
long-term storage in Question 6 below and complete Attachment B.



If no select agent organisms are indicated on Section 7A, indicate N/A or leave blank.

Examples for Completing the Section 7C, Question 2
Example 1: PI John Smith propagates Bacillus anthracis and Xanthomonas oryzae, and
stores avian influenza virus isolates (but does not propagate the virus).

Example 2: PI Jane Williams maintains a repository of Bacillus anthracis, Francisella
tularensis, Yersinia pestis, Brucella abortus, Brucella melitensis, and Brucella suis isolates
with no propagation of the agents.

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Example 3: PI Matt Jones conducts Laboratory Response Network (LRN) confirmatory tests
for Bacillus anthracis, Brucella abortus, Brucella melitensis, and Brucella suis from diagnostic
specimens, with propagation of agents.

Question 3, Maximum Quantity of Functional Toxin


For each select toxin listed in Section 7A, estimate the maximum quantity held by the PI at any
given time. A maximum quantity for all select toxins listed in Section 7A for each PI must be
provided.



The maximum quantity can be given as total amount (5 g) or volume and concentration (3 ml
of 100 ng/ml). Additional sheets may be attached if necessary.



If no toxins are indicated on Section 7A, indicate N/A or leave blank.

Examples for Completing the Section 7C, Question 3
PI Cynthia Boxwood receives botulinum neurotoxin from a commercial vendor and has
diagnostic specimens confirmed to contain ricin.

Question 4, Equipment Aerosols


If equipment that has the potential to produce infectious aerosols (e.g., ultracentrifuge, flow
cytometer, cell sorter, plate washer) is used with select agents or toxins and is contained in
primary barrier devices that exhaust air through HEPA filtration or other equivalent technology
before being discharged into the laboratory, check “Yes”.



If no such equipment is used or if this equipment is used outside of primary containment,
check “No”.
Note: Equipment that exhausts air through HEPA filtration or other equivalent technology is
not required to be contained in a primary containment barrier.

Question 5, Responsibility for Inventory


List the name(s) of the individual(s) responsible for tracking use of the select agent and/or
toxin inventory (e.g., individual(s) who update or log additions and deletions to the physical
inventory).

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

Indicate how often these inventory record(s) are reconciled by the RO (or designee). If the
inventory is reconciled other than annually, specify the frequency (e.g., weekly, monthly, every
6 months).

Question 6, Regulated Nucleic Acids


If regulated nucleic acids are held in long-term storage, check “Yes”.



If regulated nucleic acids are not held in long-term storage, check “No”.
Note: Records of regulated nucleic acids held in long-term storage are required as defined in
Section 17(a)(i) of the Select Agent Regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR
Part 331).
Note: If you do not possess extracted and isolated nucleic acids that meet the requirements
defined in Section 3(c) or Section 4(c) of the Select Agent Regulations (42 CFR Part 73, 9
CFR Part 121, and 7 CFR Part 331), check “No”. The registration of intact, live agent is
sufficient to cover the genomic material in that agent as long as it is not extracted and isolated
for further testing or research purposes.

Question 7, Decontamination


If all cultures, stocks, and other regulated waste are decontaminated before removal from the
entity, check “Yes”.



If yes, check the box next to the applicable method(s) used for the decontamination. If
chemical disinfection is used, indicate the type of disinfectant, the concentration, and the
contact time.



If decontamination does not occur prior to removal of waste from the entity, check “No”.



If waste is incinerated, indicate whether incineration occurs onsite or if waste is transported to
an offsite facility for incineration.



If waste is transported offsite, indicate whether another decontamination method is utilized
prior to removal from the facility.



For any other method of decontamination, describe the method used.

Question 8, Security of Written Records


Indicate the means used to secure written records that would allow someone the ability to gain
access to select agents and toxins. Examples of such written records may include a paper list
of PIN combinations that allow access or the combination to a box where a key allowing
access is stored.



If the security measures listed do not describe the control of written documents at the entity,
check “Other” and describe the security measures in place.

Question 9, Specific Types of Work


Complete by answering “Yes” or “No” to all questions.



If you answer yes to a question, complete the attachment specified using the directions
provided.
Note: If registering for recombinant/synthetic nucleic acids encoding a select agent toxin but
not the toxin itself, Attachment A – Work with Toxins is not required, but Attachment B – Work

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with Regulated Nucleic Acids, Genetic Modification of Select Agents or toxins,
Recombinant/Synthetic Nucleic Acids, or Recombinant Synthetic Organisms is required.
Note: If the entity is not registered for a select toxin(s), but performs work with a select toxin(s)
below the permissible amount, Attachment A will not be completed.
Note: If the entity is registered for recombinant/synthetic nucleic acids in a storage only
capacity, Attachment B will not be completed.
Note: If entity is working with arthropods in a diagnostic capacity only with field collected
specimens, only Question 1 of Attachment E will be completed.

Question 10, BSL3Ag or BSL4 Laboratories


Complete by answering “Yes” or “No” to all questions.



If you answer yes to a question, complete the attachment specified using the directions
provided.

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Attachment A - Work with Toxins
This attachment is used to assess work with select toxins. Multiple, complete Attachment As for a PI’s
Section 7 may need to be submitted if work is performed at different biosafety levels. Complete this
section by checking either “Yes” or “No” for all questions and entering additional information when
prompted.
If the question does not apply to your entity, answer “No”.
Additional guidance is provided below; if further information or guidance is required, please contact
the CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.

Select Toxin Additional Information


HHS toxins are excluded from the Select Agent Regulations only when the toxin under the
control of a PI, treating physician or veterinarian, or commercial manufacturer or distributor is
below the aggregate amount and does not, at any time, exceed the amounts defined in 42
CFR 73.3(d)(3) and shown below:
HHS Toxins

Amount

Abrin

1000 mg

Botulinum neurotoxin
Conotoxins

1.0 mg

(1)

100 mg

Diacetoxyscirpenol

10,000 mg

Ricin

1000 mg

Saxitoxin

500 mg

Staphylococcal enterotoxins (2)

100 mg

T-2 toxin

10,000 mg

Tetrodotoxin

500 mg

(1) The conotoxins that are regulated by FSAP will be limited to the short, paralytic
alpha conotoxins containing the following nucleic acid sequence,
X1CCX2PACGX3X4X5X6CX7, whereas:
(a) C= Cysteine residues;
(b) The consensus sequence includes known toxins α-MI and α-GI (shown above)
as well as α-GIA, Ac1.1a, α-CnIA, α-CnIB
(c) X1 = any amino acid(s) or Des-X;
(d) X2 = Asparagine or Histidine;
(e) X3 = Arginine or Lysine;
(f) X4 = Asparagine, Histidine, Lysine, Arginine, Tyrosine, Phenylalanine or
Tryptophan;
(g) X5 = Tyrosine, Phenylalanine, Tryptophan; X6 = Serine, Threonine, Glutamine,
Asparagine, Asparagine; X7 = Any amino acid(s) or Des X) and;
(h) “Des X” indicates that the amino acid can be absent at this position. For
example if a peptide sequence were XCCHPA then the related peptide CCHPA
would be designated as Des-x.
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The short, paralytic alpha conotoxins containing the following nucleic acid
sequence X1CCX2PACGX3X4X5X6CX7 will be considered a select toxin if the total
amount (all forms) under the control of a principal investigator, treating physician or
veterinarian, or commercial manufacturer or distributor exceeds 100mg at any time.
(2) FSAP regulates A, B, C, D, E only.

Notes:


If registering for recombinant/synthetic nucleic acids encoding a select agent toxin but not the
toxin itself, Attachment A – Work with Toxins is not required, but Attachment B – Work with
Regulated Nucleic Acids, Genetic Modification of Select Agents or Toxins,
Recombinant/Synthetic Nucleic Acids, or Recombinant Synthetic Organisms is required.



HHS toxins may be excluded from these requirements as defined in 42 CFR 73.3(d)(3) if the
maximum amount possessed at any time by the PI is below the regulated aggregate amount.



After a formal request, evaluation and approval by the FSAP certain strains, genotypes,
biotypes, or subgroups of select agents or toxins may be excluded from regulation. An
attenuated strain of a select agent or a select toxin modified to be less potent or toxic may be
excluded from the requirements of this part based upon a determination by the HHS Secretary
that the attenuated strain or modified toxin does not pose a severe threat to public health and
safety. Excluded strains are usually sought out and approved for use in basic or applied
research, as positive controls, for diagnostic assay development, or for the development of
vaccines and therapeutics. However, an individual or entity that possesses, uses, or transfers
an excluded strain will again be subject to the regulations if there is any reintroduction of
factor(s) associated with virulence or other manipulations of any kind that modify the
attenuation such that virulence is restored or enhanced. Unless specifically excluded under 42
CFR 73.3 and 73.4, 7 CFR 331.3 and 331.4, and 9 CFR 121.3 and 121.4, any select agent or
toxin is subject to the entirety of the Select Agent Regulations. The current list of select agent
exclusions can be viewed at Select Agents and Toxins Exclusions.



A registered entity is required to meet all of the regulatory requirements for each select agent
and/or toxin listed on the APHIS/CDC Form 1 regardless of whether the select agent or toxin is
in the actual possession of the entity and without regard to the actual amounts of toxins in
possession. Refer to the Policy Statement posted to the FSAP website August 25, 2014 for
more information.



Once the entity’s registration has been approved for the select toxin, the entity must maintain
compliance with the Select Agent Regulations for work and/or storage of the toxin. All activities
related to the registered PI’s work with functional select toxins must be in compliance with the
Select Agent Regulations (e.g., stored/manipulated in registered rooms, inventory records,
chemical hygiene plan in effect).



All inoculations or exposures of animals to select toxins must occur in registered laboratories.
Following inoculation or exposure, the animal is not considered a select toxin.



The FSAP regulates select agent and toxin nucleic acids that encode for the functional form(s)
of any of the select toxins if the nucleic acids can be expressed in vivo or in vitro, or are in a
vector or recombinant host genome and can be expressed in vivo or in vitro. If the proposed
work will involve the deliberate formation of recombinant and/or synthetic DNA containing
genes for the biosynthesis of select toxins or the possession of such a product, Attachment B
must be completed and will require approval by the FSAP. Recombinant and/or synthetic
nucleic acids that encode functional domain(s) of select toxins meet these criteria and are also
regulated. Functional domains are subunits of the toxin-encoding gene. Lack of biological

APHIS/CDC Form 1 Instructions

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effect cannot be assumed and experimental data from a recognized biological model (either in
vivo or in vitro) of toxin activity should be submitted to the FSAP for consideration before
subunits of regulated toxin genes can be excluded from regulation. For additional information
regarding recombinant and/or synthetic DNA containing genes for the biosynthesis of select
toxins, refer to Synthetic Genomics.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


PI


Fill out the name of the Principal Investigator(s) for which this attachment is being completed.
Use first initial followed by last name, separate multiple PI names with commas.

Laboratory Safety Level:


Choose the appropriate laboratory safety level for the work described. If the questions within
this attachment will be answered differently for specific safety levels, provide a separate
attachment for each safety level.

Question 1, Chemical Hygiene Plan


If a Chemical Hygiene Plan (CHP) that is both site- and toxin-specific is freely available to staff
working with select toxins, check “Yes”.



If a CHP is not available, check “No”.
Note: Access to the CHP may be electronic, and the CHP must be reviewed annually by staff
working with select toxins.

Question 2, Toxin Manipulation or Production


Indicate if you manipulate or produce dry (lyophilized, freeze-dried, or other) or liquid forms of
any select toxins.

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Note: Dry forms of protein toxins and/or any procedures that could aerosolize toxin require
special safety measures. If you perform any potential aerosol-generating procedures such as
centrifugation or chromatography, indicate that work in the work objectives in Section 7.

Question 3, Animal Exposure


If animals are exposed to select toxins, check “Yes” and indicate if the exposure procedure(s)
is/are performed in registered laboratories by checking yes or no in Question 3a.



If animals are not exposed to select toxins, check “No”.



See the “Guidance on the Inventory of Select Agents and Toxins” posted to Long Term
Storage for additional guidance in answering this question.
Note: If animals are exposed to select toxins, Questions 1, 2, and 8 in Attachment C – Work
with Animals must be completed.

Question 4, Toxin Production


If select toxins are produced by the PI, check “Yes” and provide a brief description of the
method and an estimate of the maximum quantities during production, purification, and
maximum concentration achieved at any point during the production or purification process. In
the narrative, indicate if you have the capability of producing select toxins either chemically, in
vitro, or in vivo onsite.



If select toxins are not produced by the PI, check “No”.
Note: Describe your production capability fully so that the FSAP can assess its impact on the
safety and security challenges faced by your entity.

Examples for Completing Attachment A, Question 4

Question 5, Hazard Sign


If a hazard sign is posted when select toxins are in use, check “Yes”.



If a hazard sign is not posted when select toxins are in use, check “No”.

Question 6, Select Toxin Inactivation


If all select toxins, cultures, stock, materials coming into contact with toxins, and other
regulated wastes are appropriately inactivated prior to disposal, check “Yes”.



If yes, check the box next to the applicable method(s) used for the decontamination. If
chemical disinfection is used, indicate the type of disinfectant, the concentration, and the

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contact time. If waste is incinerated, indicate whether incineration occurs onsite or if waste is
transported to an offsite facility for incineration. If waste is transported offsite, indicate whether
another decontamination method is utilized prior to removal from the facility.


For any other method of decontamination, describe the method used.



If all select toxins, cultures, stock, materials coming into contact with toxins, and other
regulated wastes are not appropriately inactivated prior to disposal, check “No”.
Note: Select toxins may be resistant to routine methods of inactivation used in the laboratory
and must be treated appropriately. Special challenges may exist based on toxin structure
and/or chemical resistance. Chemical inactivation of select toxins is affected by many factors.
A risk assessment must be considered when establishing the most effective method to be
used for toxin inactivation. Cross-contamination and absorption or adsorption of certain toxins
is of special concern. Therefore, all materials that have the possibility of contact with toxins
must be handled as if they were contaminated and treated accordingly.

Question 7, Dilution/Manipulation of Concentrated Select Toxins


If dilution procedures and other manipulations of concentrated select toxins are performed,
check “Yes”.



If yes, indicate where these activities are performed by checking all applicable locations and if
two or more knowledgeable people are present.



If dilution procedures and other manipulations of concentrated select toxins are not performed,
check “No”.
Note: Select toxins are often potent in very dilute preparations; therefore, special care must be
exercised when manipulating concentrated preparations of select toxins. Concentration(s) of
manipulated select toxins should be listed in the work objectives in Section 7.

Question 8, Intra-entity Select Toxin Transfers


If select toxins are transferred (intra-entity transfer) to other individuals at the entity outside of
the laboratory producing or receiving the toxin, check “Yes” and indicate whether amounts
above and/or below the regulated aggregate amounts are transferred.



If select toxins are not transferred to other individuals at the entity outside of the laboratory
producing or receiving the toxin, check “No”.
Note: Regulated toxin amounts are described in 42 CFR 73.3 (d)(3) and are available at
SelectAgents.gov.
Note: Entities must ensure that select toxin amounts otherwise excluded under 42 CFR
73.3(d)(3) are transferred only after the transferor uses due diligence and documents that the
recipient has a legitimate need (i.e., reasonably justified by a prophylactic, protective, bona
fide research, or other peaceful purpose) to handle or use such toxins. The HHS Secretary
retains the authority to, without prior notification, inspect and copy or request the submission of
the due diligence documentation to the CDC.

Question 9, Inter-entity Select Toxin Transfers


If select toxins are transferred to other entities (inter-entity transfer) in quantities below the
regulated aggregate amounts, check “Yes”.



If select toxins are not transferred to other entities in quantities below the regulated aggregate
amounts, check “No”.

APHIS/CDC Form 1 Instructions

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Note: Regulated toxin amounts are described in 42 CFR 73.3 (d)(3) and are available at
SelectAgents.gov. Any transfer above the regulated aggregate toxin amounts must be
approved using an APHIS/CDC Form 2 and be between SRA-approved PIs at registered
entities registered to possess the toxin.
Note: Entities must ensure that select toxin amounts otherwise excluded under 42 CFR
73.3(d)(3) are transferred only after the transferor uses due diligence and documents that the
recipient has a legitimate need (i.e., reasonably justified by a prophylactic, protective, bona
fide research, or other peaceful purpose) to handle or use such toxins. The HHS Secretary
retains the authority to, without prior notification, inspect and copy or request the submission of
the due diligence documentation to the CDC.

Question 10, Commercial Distribution


If select toxins are commercially distributed/shipped outside of the laboratory producing the
toxin, check “Yes” and indicate if there is a hazard communication plan available.



If select toxins are not commercially distributed/shipped outside of the laboratory producing the
toxin, check “No”.
Note: Commercial entities are required to have a hazard communication plan that addresses
the safety and security considerations of other federal agencies (e.g., the Department of
Transportation).

Question 11, Recombinant Work


If work will 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, check “Yes”.



If work will not 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, check “No”.
Note: If yes, Attachment B - Work with Regulated Nucleic Acids, Genetic Modification of
Select Agents or Toxins, Recombinant/Synthetic Nucleic Acids, or Recombinant Synthetic
Organisms must be completed.
Note: For additional information regarding recombinant and/or synthetic DNA containing
genes for the biosynthesis of select toxins, refer to Synthetic Genomics.

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Attachment B - Work with Regulated Nucleic Acids, Genetic
Modification of Select Agents or Toxins, Recombinant/Synthetic
Nucleic Acids, or Recombinant Synthetic Organisms
This attachment is used to assess any work which may be performed with genetic elements,
recombinant nucleic acids or recombinant organisms at an entity. Multiple, complete Attachment Bs
for a PI’s Section 7 may need to be submitted if work is performed at different biosafety levels.
Complete this section by checking either “Yes” or “No” for all questions and entering additional
information when prompted.
If the question does not apply to your entity, answer “No”.
Additional guidance is provided below; if further information or guidance is required, please contact
the CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


PI


Fill out the name of the Principal Investigator(s) for which this attachment is being completed.
Use first initial followed by last name, separate multiple PI names with commas.

Laboratory Safety Level:


Question 1, Possession, Use, or Transfer


Check yes or no for Questions 1a-c to indicate if the entity will possess, use, or transfer of any
of the listed materials.

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(a) Positive strand RNA viruses containing nucleic acids that can produce infectious virions (or
particles).
HHS Select Agent Regulated Nucleic Acids
Genomic material – Eastern Equine Encephalitis virus
Genomic material – Kyasanur Forest disease virus
Genomic material – Omsk Hemorrhagic Fever virus
Genomic material – SARS–associated coronavirus
Genomic material – Tick-borne encephalitis virus, Far Eastern subtype
Genomic material – Tick-borne encephalitis virus, Siberian subtype
Overlap Select Agent Regulated Nucleic Acids
Genomic material – Venezuelan Equine Encephalitis virus
USDA Veterinary Services (VS) Select Agent Regulated Nucleic Acids
Genomic material – Classical Swine Fever virus
Genomic material – Foot-And-Mouth Disease virus
Genomic material – Swine Vesicular Disease virus

(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.
Note: Recombinant and/or synthetic nucleic acids that encode functional domain(s) of select
toxins meet these criteria and are also regulated. Functional domains are subunits of the
select toxin-encoding gene of any length that have a deleterious biological effect. Lack of
biological effect should not be assumed, experimental data from a recognized biological model
(either in vivo or in vitro) of toxin activity should be submitted to the FSAP for consideration
before subunits of regulated toxin genes can be excluded from regulation.
HHS Select Toxin Regulated Nucleic Acids
Recombinant/synthetic nucleic acids encoding Abrin
Recombinant/synthetic nucleic acids encoding Botulinum neurotoxin
Recombinant/synthetic nucleic acids encoding Conotoxins
Recombinant/synthetic nucleic acids encoding Ricin
Recombinant/synthetic nucleic acids encoding Staphylococcal enterotoxin

(c) Genetic modifications include but are not limited to: point mutants, chimeras, insertions,
truncations or any intentionally-generated modification of the primary nucleic acid sequence.
Note: Any unique markers or phenotypic characteristics that differentiate a strain from the
parental organism must be indicated in Section 7B strain table.
Note: For additional information regarding regulated nucleic acids as defined in Section 3(c)
and Section 4(c) of the Select Agent Regulations, refer to Synthetic Genomics.

Question 2, Recombinant Work


Check yes or no for Questions 2a-d to indicate if work will involve any of the listed materials
and/or methods.
a) Genetic elements are sequences of nucleic acids. If work will involve the introduction
and/or modification of genetic elements in a select agent or toxin, check “Yes”.

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If work will not involve the introduction and/or modification of genetic elements, check “No”.
b) Recombinant nucleic acids are defined as (i) molecules that are constructed by joining
nucleic acid molecules and that can replicate in a living cell or (ii) molecules that result
from the replication of those described in (i) above. Synthetic nucleic acids are (i)
molecules that are chemically or by other means synthesized or amplified, including those
that are chemically or otherwise modified but can base pair with naturally occurring nucleic
acid molecules (i.e., synthetic nucleic acids) or (ii) molecules that result from the replication
of those described in (i) above. If work will involve recombinant and/or synthetic nucleic
acids with select agents or toxins, check “Yes”.
If work will not involve recombinant and/or synthetic nucleic acids with select agents or
toxins, check “No”.
c) If work will involve recombinant or synthetic organisms that are subject to the Select Agent
Regulations (42 CFR 73.13, 7 CFR 331.13 or 9 CFR 121.13), check “Yes”.
Note: If regulated recombinant and/or synthetic nucleic acids (as defined in Question 1a
and 2b) are introduced into either a select agent organism, or a host organism used for
molecular cloning (e.g., E. coli encoding botulinum neurotoxin or Staphylococcus aureus
containing an expression vector encoding SEB), the resulting recombinant and/or synthetic
organism would be subject to the regulations.
If work will not involve recombinant or synthetic organisms, check “No”.
d) If work will involve a 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, check “Yes”.
If a reverse genetic system or any complete set of reagents that would allow rescue of
infectious virus is not used or available, check “No”.
Note: For additional information regarding genetic modification of select agents and
toxins, recombinant and/or synthetic nucleic acids, or recombinant and/or synthetic
organisms, refer to Synthetic Genomics.

Question 3, Restricted Experiments


If a restricted experiment(s) will be performed as defined in Section 13 of the Select Agent
Regulations (42 CFR 73.13, 7 CFR 331.13 or 9 CFR 121.13), check “Yes” and complete
Questions 3a-b to indicate the type(s) of restricted experiment(s) that will be performed and
the approval status of this restricted experiment.



If a restricted experiment(s) will not be performed as defined in Section 13 of the Select Agent
Regulations (42 CFR 73.13, 7 CFR 331.13 or 9 CFR 121.13), check “No”.
(a) Include drug or chemical resistant traits that could compromise the control of disease
agents in humans, veterinary medicine, or agriculture. Note: Chemical resistance applies to
plant pathogens.
(b) If approval has been obtained from the APHIS Administrator or HHS Secretary, check
“Yes”. If approval has not been obtained from the APHIS Administrator or HHS Secretary,
check “No”.
Note: For additional information regarding restricted experiments, refer to Restricted
Experiments.

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Question 4, Products of a Restricted Experiment


If work will involve possession, use or transfer of a product of a restricted experiment, check
“Yes” and complete Questions 4a-b to indicate the type(s) of restricted product and the
approval status of the restricted experiment.



If work will not involve possession, use or transfer of a product of a restricted experiment,
check “No”.
(a) Include all products of a restricted experiment created after December 4, 2012 whether
acquired from a different PI at the same entity or from a different entity. These products
include: chemical/drug resistant select agents and/or intermediate products with drug or
chemical resistant traits that meet the definition of a restricted experiment, nucleic acids
capable of expressing a functional select toxin or a functional subunit of a select toxin, and a
host organism containing nucleic acids capable of expressing a functional select toxin or a
functional subunit of a select toxin. Note: Chemical resistance applies to plant pathogens.
(b) If approval has been obtained from the APHIS Administrator or HHS Secretary, check
“Yes”. If approval has not been obtained from the APHIS Administrator or HHS Secretary,
check “No”.
Note: For additional information regarding products of a restricted experiment, refer to
Restricted Experiments.

Question 5, Enhanced/Restored Virulence


If experiments will involve the acquisition of increased/restored virulence (e.g., drug or
chemical resistance, increased host range, enhanced transmissibility, infectivity,
environmental stability) in select agents or toxins, check “Yes”. If experiments will not involve
the acquisition of increased/restored virulence (e.g., drug or chemical resistance, increased
host range, enhanced transmissibility, infectivity, environmental stability) in select agents or
toxins, check “No”.



If unknown or not sure, check “Yes” and provide an explanation in Question 6.
Note: An individual or entity that possesses, uses, or transfers an excluded strain will again be
subject to the regulations if there is any reintroduction of factor(s) associated with virulence or
other manipulations of any kind that modify the attenuation such that virulence is restored or
enhanced. Provide details on work and factors re-introduced to excluded strains.
Note: Chimeric viruses whose genomes contain the backbone and replication machinery of a
select agent virus or contain genes from different select agent viruses are regulated.
Regulated chimeric viruses have to be evaluated on a case-by-case basis to determine if the
viruses exhibit sufficient attenuation to be excluded. Chimeras that are comprised of select
agent and non-select agent genes from the same virus family require careful review to
determine select agent status. It is the entity’s responsibility to determine if the resultant
chimera is a select agent; however, the FSAP encourages entities to submit these types of
chimeras for review.
Note: The purpose of this question is to assess the safety and security of modified select
agents and toxins (or restoration of virulence to FSAP excluded strains of select agents and
toxins) to laboratory personnel and the environment in the context of containment and
potential increased risk(s) associated with the select agent or toxin. If this question is checked
yes, provide further details on safety and/or security considerations that may be used to
mitigate potential risk(s) to laboratory personnel and the environment in Question 6. The
current list of select agent exclusions can be viewed at Select Agents and Toxins Exclusions.

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Question 6, Work Description
 For questions 1-5 in this attachment where “Yes” was indicated, provide a brief description of
genetic modifications, any recombinant and/or synthetic constructs and any associated
expression control elements, including what the recombinant and/or synthetic DNA encodes, if
known. Also, describe any in vitro or in vivo assays.



Attach additional pages and/or maps of the recombinant/synthetic construct(s),
cloning/expression vector(s) as applicable.

Examples for Completing Attachment B, Question 6
Example 1, yes to Question 1a

Example 2, yes to Questions 1a and1b

Example 3, yes to Question 5

Question 7, Institutional Biosafety Committee Review/Approval


If an IBC reviews and approves protocols to perform recombinant and/or synthetic work with
select agents and toxins at this facility, check “Yes” and indicate if the IBC has approved the
recombinant and/or synthetic work described in this attachment.



If an IBC does review and approve protocols to perform recombinant and/or synthetic work
with select agents and toxins at this facility but has not approved the work described in the
attachment, provide an explanation for the absence of review and/or approval.



If an IBC does not review and approve protocols to perform recombinant and/or synthetic work
with select agents and toxins at this facility, check “No” and provide an explanation.

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Attachment C - Work with Animals
This attachment is used to assess work with animals. Multiple, complete Attachment Cs for a PI’s
Section 7 may need to be submitted if work is performed at different biosafety levels. Complete this
section by checking either “Yes” or “No” for all questions and entering additional information when
prompted.
If the question does not apply to your entity, answer “No”.
Additional guidance is provided below; if further information or guidance is required, please contact
the CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


PI


Fill out the name of the Principal Investigator(s) for which this attachment is being completed.
Use first initial followed by last name, separate multiple PI names with commas.

Laboratory Safety Level


Question 1, Select Agents/Toxins, Animals and Routes of Administration


Indicate each select agent listed in Section 7A that will be used in animals, provide the species
of animal (genus & species name, as well as common name) and all routes of administration
of the select agent or toxin. Enter select agents or toxins exactly as they appear on the
current, approved Select Agent/Toxin List. Do not abbreviate.
Note: IC = Intracranial, IN = Intranasal (i.e. with syringe or nasal cannula, not exposure with
aerosol generating equipment – see below), IT = Intratracheal, IP = Intraperitoneal, IM =
Intramuscular, SC = Subcutaneous, ID = Intradermal, IV = Intravenous, IA = Intra-arterial.

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Spell out ocular, oral, mucosal, intracapsular injection of joint spaces, intrathoracic injections
other than IT, and any other routes of administration.
Note: Indicate “aerosol” if you use any equipment (e.g., nebulizer) to expose animals to
aerosols.

Examples for Completing the Attachment C, Question 1
Example 1:

Example 2:

Question 2, Aerosol Exposures



If animals are exposed to select agents or toxins by the aerosol route, check “Yes” and
indicate if the aerosol exposure equipment is used within a primary containment device.
If animals are not exposed to select agents or toxins by any intentional aerosol generating
route, check “No”.

Question 3, Waste Stream


Describe the waste stream of the laboratory as it relates to animal work by completing
Questions 3a and b and providing relevant details as appropriate.

(a) If animal carcasses, cages, and waste (e.g., sewage, bedding) are treated prior to disposal by
an approved method, check “Yes” and describe the treatment method(s) by checking all
applicable methods and providing relevant details of the treatment method(s) as appropriate
(e.g., if you autoclave and then incinerate, check the box for autoclave and describe your
autoclave protocol including time, temperature, and pressure and check the box for
incineration). If animal carcasses, cages, and waste (e.g., sewage, bedding) are not treated
prior to disposal by an approved method, check “No”.
Example for Question 3a:

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(b) Indicate if waste is decontaminated inside the containment area (e.g., pass-through autoclave
loaded within containment in the animal facility) or if waste is transported outside the
containment area for decontamination. If waste is transported outside the containment area
for decontamination, describe when and how waste is treated before transport out of the
containment area.
Example for Question 3b:

Question 4, Inactivation


Describe any inactivation (e.g., formalin fixation, lysis of cells for nucleic acid extraction,
irradiation) of samples collected from infected animals that will be manipulated at a lower
biosafety level. Include concentration or dosage and contact/exposure time, as applicable.
Note: Refer to Guidance for the Inactivation of Select Agents and Toxins and Rending
Samples Free of Select Agents and Toxins.

Example for Completing the Attachment C, Question 4

Question 5, Institutional Animal Care and Use Committee (IACUC)


If the entity requires that an IACUC review and approve protocols prior to work with animals at
this entity, check “Yes”.



If an IACUC reviews protocols prior to work with animals at this entity but has not approved the
work described here, provide an explanation for the absence of review and/or approval.



If the entity’s IACUC approval has not yet been sought, but work will not begin until it is
approved by the IACUC, indicate this in the explanation.



If the entity does not require that an IACUC review and approve protocols prior to work with
animals at this entity, check “No”.
Note: Corporate or private entities may not have these committees.

Question 6, AAALAC Accreditation


If the laboratory is accredited by the Association for Assessment and Accreditation of
Laboratory Animal Care (AAALAC), check “Yes” and provide the most recent accreditation or
re-accreditation date.



If the laboratory is not accredited by the AAALAC, check “No”.

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Note: Some corporate or private entities may not seek this accreditation; check “No”.

Question 7, Animal Tracking


If there is a system in place for recording the number of animals infected, the number of
animals disposed of, and these records are reviewed frequently, check “Yes” and describe the
method used to track and account for animals from the time of exposure to the select agent
until final disposition (e.g., daily counts recorded manually by laboratorians and/or animal care
staff, computerized inventory systems that include barcoding of cages as well as daily counts
of individual animals). Indicate if unique animal identifiers such as ear tags or brands are used
and include the frequency of reconciliation of records (e.g., daily counts checked against
inventory database).



Check “No” if there is not a system in place for recording each of the following elements: the
number of animals infected, the number of animals disposed, and the frequency of records
review.
Note: A current accounting of animals as described in Section 17(a)(2) of the Select Agent
Regulations is required. For additional information, refer to the Guidance Document on the
Inventory Requirements for Select Agents or Toxins.

Note for Questions 8 – 12 below: The purpose of these questions is to assess that the biosafety
and containment practices are commensurate with the risk of the select agent or toxin given its
intended use.

Question 8, Animal Restraint


If animals are restrained for experimental manipulation, check “Yes”.



If animals are not restrained for experimental manipulation, check “No” and provide an
explanation.

Question 9, Animal Monitoring


If animals are monitored before experimental endpoint (e.g., daily checks), check “Yes”.



If animals are not monitored before experimental endpoint (e.g., daily checks), check “No” and
provide an explanation.

Question 10, Animal Housing


Describe how animals are housed by 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
enclose). Actively ventilated caging systems have both a supply and exhaust fan; passive
ventilation is provided by an exhaust fan only. The following are examples of housing:
conventional caging housed within HEPA filtered isolators, HEPA filtered cage racks,
individual HEPA filtered cages, open cages, loose-housing.

Note: For entities performing work with recombinant select agents in non-human primates housed
in conventional/non-containment caging at ABSL4, refer to Appendix G of the NIH Guidelines for
Research Involving Recombinant or Synthetic Nucleic Molecules (NIH Guidelines).

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Example for Completing the Attachment C, Question 10

Question 11, Method of Euthanasia


If animals will be euthanized, check “Yes”.



If animals will not be euthanized, check “No” and provide an explanation.

Question 12, Necropsies


If animals will be necropsied, check “Yes” and describe the necropsy procedures (e.g.,
instruments or implements used, on downdraft table).



If animals will not be necropsied or sampled post- or peri-mortem, check “No”.
Note: Materials collected (e.g., blood and tissue samples) from select agent infected animals
are select agents and must be handled only by SRA-approved individual(s) and stored in
registered areas until inactivated or assayed and shown that the select agent is absent.
Note: For additional information regarding inventory of material collected from experimentallyinoculated animals, refer to the Guidance Document on the Inventory Requirements for Select
Agents or Toxins.

Example for Completing Attachment C, Question 12

Question 13, Securing Animal Carcasses


Describe how animal carcasses are secured prior to decontamination by checking all methods
used.



If “Other” is selected, enter explanation.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Attachment D - Work with Plants
This section is used to assess work with plants. Multiple, complete Attachment Ds for a PI’s Section 7
may need to be submitted if work is performed at different biosafety levels. Complete this section by
checking either “Yes” or “No” for all questions and entering additional information when prompted.
If the question does not apply to your entity, answer “No”.
Additional guidance is provided below; if further information or guidance is required, please contact
the CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date




Fill out the name of the Principal Investigator(s) for which this attachment is being completed.
Use first initial followed by last name, separate multiple PI names with commas.

Laboratory Safety Level


Question 1, Select Agents, Plants and Routes of Inoculation


Indicate each select agent listed in Section 7A that will be used in plants. Enter the species of
plant (genus & species name, as well as common name) and any and all routes of inoculation
of the select agent.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Example for Completing Attachment D, Question 1

Question 2, Plant Waste Treatment




If all plant waste is treated prior to disposal (e.g., soil, plant material, materials accompanying
plants or samples) by an approved method, check “Yes.”
If yes, describe the treatment method(s) by checking all applicable methods and providing
relevant aspects of the method(s) selected for decontamination as appropriate.
If all plant waste is not treated prior to disposal (e.g., soil, plant material, materials
accompanying plants or samples) by an approved method, check “No.”

Question 3, Vectors



If experiments will involve vectors, check “Yes” and complete Questions 3a-d to describe the
vectors and their containment parameters.
If experiments will not involve vectors, check “No”.
Note: If yes, Attachment E – Work with Arthropods must be completed.

Question 4, Glass House



If plants exposed to select agents will be housed or manipulated in a glass house, check “Yes”
and complete Questions 4a-f to describe the glass house.
If plants exposed to select agents will not be housed or manipulated in a glass house, check
“No”.

Question 5, Greenhouse



If plants exposed to select agents will be housed or manipulated in a greenhouse, check “Yes”
and complete Questions 5a-f to describe the greenhouse.
If plants exposed to select agents will not be housed or manipulated in a greenhouse, check
“No”.

Question 6, Screen House



If plants exposed to select agents will be housed or manipulated in a screen house, check
“Yes” and complete Questions 6a-g to describe the screen house.
If plants exposed to select agents will not be housed or manipulated in a screen house, check
“No”.

Question 7, Growth Chamber


If plants exposed to select agents will be housed or manipulated in a growth chamber, check
“Yes” and complete Questions 7a-j to describe the growth chamber.



If plants exposed to select agents will not be housed or manipulated in a growth chamber,
check “No”.

APHIS/CDC Form 1 Instructions

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When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
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Question 8, Recombinant Work


If work will be performed with regulated nucleic acids, genetic modification of select agents or
toxins, recombinant/synthetic nucleic acids or recombinant/synthetic organisms, check “Yes”.



If work will not be performed with regulated nucleic acids, genetic modification of select agents
or toxins, recombinant/synthetic nucleic acids or recombinant/synthetic organisms, check “No”.
Note: If yes, Attachment B - Work with Regulated Nucleic Acids, Genetic Modification of
Select Agents or Toxins, Recombinant/Synthetic Nucleic Acids, or Recombinant Synthetic
Organisms must be completed.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Attachment E - Work with Arthropods
This attachment is used to assess any work which may be performed with arthropods at an entity.
Multiple, complete Attachment Es for a PI’s Section 7 may need to be submitted if work is performed
at different biosafety levels. Complete this section by checking either “Yes” or “No” for all questions
and entering additional information when prompted.
If the question does not apply to your entity, answer “No”.
Additional guidance is provided below; if further information or guidance is required, please contact
the CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.
Note: A useful reference to aid in completing this attachment is: Vector Borne Zoonotic Dis. 2003
Summer;3(2):61-98, Arthropod containment guidelines: A project of the American Committee of
Medical Entomology and American Society of Tropical Medicine and Hygiene (as referenced in the
BMBL Appendix E).

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


PI


Fill out the name of the Principal Investigator(s) for which this attachment is being completed.
Use first initial followed by last name, separate multiple PI names with commas.

Laboratory Safety Level


Question 1, Field-Collected Arthropods


If work is performed with field-collected arthropods in a diagnostic capacity only (e.g., protein
and/or nucleic acid extraction) for identification of select agents, check “Yes”.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
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

If work is not performed with field-collected arthropods in a diagnostic capacity for identification
of select agents, check “No”.
Note: If any work beyond destructive diagnostic testing is performed with arthropods (e.g.,
colonization of arthropods from the field, cultivation of select agents in field-collected
arthropods), check “No” and proceed to questions 2-16.
Note: If you perform work with select agents and arthropods but check no to both Questions 1
and 2, attach additional sheets as necessary to explain your work, and consult with
APHIS/CDC as to how to complete Attachment E.
Note: Work with select agents in their naturally occurring environment is not regulated as long
as the select agent has not been intentionally introduced, cultivated, collected, or otherwise
extracted from its natural source.

Question 2, Experimental Inoculations


If work is performed to experimentally inoculate or infect any life stage (i.e. larvae, pupae, or
adult) of arthropods with select agents, check “Yes” and complete Questions 3-16.



If work is not performed to experimentally manipulate arthropods and select agents, check
“No” and do not complete the remaining questions (3-16) in this attachment.
Note: Work with select agents in their naturally occurring environment is not regulated
provided that the agent has not been intentionally introduced, cultivated, collected, or
otherwise extracted from its natural source.

Question 3, Select Agents and Arthropods


Indicate each select agent listed in Section 7A that will be used in arthropods. Enter the
species of arthropod (genus and species name).

Example for Completing Attachment E, Question 3

Question 4, Exposure Routes


Describe the method of arthropod exposure by completing Questions 4a-d and providing
relevant aspects of the exposure method(s) as appropriate.



If insects are fed on select agent-infected plants, check box 4c and fill out Attachment D Work with Plants.



If the arthropod exposure route is not listed check box 4d (Other) and provide a description.
Note: If uninfected blood is used to feed arthropods for colony maintenance only, check “No”
to 4b.
Note: If collected blood is inoculated with agent and used to feed arthropods indicate this by
checking “Collected blood”.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
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Question 5, Containment and Transfer of Infected Arthropods


Describe procedures used for primary containment during maintenance and any transfer(s) of
infected arthropods. Address primary containment features of caging systems and include any
secondary containment equipment used to transfer of arthropods within or between
insectaries, laboratories and/or containment facilities. Provide a description of the procedures
used for primary containment and any transfer(s) of infected arthropods (e.g., “clear, latched
secondary containers to assess escape of arthropods from the primary container before
opening the secondary container”, “opaque friction-closing secondary containers opened in
primary containment glove box to prevent accidental release”).
Note: The purpose of this question is to assess the safety and security of laboratory staff and
the environment in the context of containment and movement of arthropods. Answer the
question with sufficient detail to allow APHIS or CDC to assess the adequacy of caging and
containment in the context of exposure of personnel or the environment to select agentinfected vectors.

Question 6, Infected Arthropods Records


If there is a system in place for recording the number of arthropods infected, the number of
arthropods disposed of, and these records are reviewed frequently, check “Yes” and describe
the system. Include sufficient detail to allow a person unfamiliar with your specific system to
understand the concepts and check-points that exist in the system (e.g., daily counts recorded
manually by laboratorians, computerized inventory systems that include barcoding of cages as
well as daily counts of individual arthropods). Indicate if unique arthropod identifiers such as
fluorescent dye spots or visible genetic mutations (e.g. red eyes) are used and the frequency
of records reconciliation (e.g., daily counts checked against inventory database).



If there is not a system in place for recording each of these elements, check “No”.
Note: A current and accurate accounting of arthropods experimentally inoculated with select
agents is required as defined in Section 17(a)(2) of the Select Agent Regulations (42 CFR Part
73, 9 CFR Part 121, and 7 CFR Part 331). For additional information, refer to the Guidance on
the Inventory Requirements for Select Agents and Toxins.

Question 7, Containment Design and Operational Procedures


If 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, check “Yes”.



If arthropod containment laboratory design and operational procedures are not developed and
implemented in accordance with guidance found in the current edition of the Arthropod
Containment Guidelines, check “No”.
Note: Consult with your designated FSAP representative or contact the CDC at 404-718-2000
or APHIS at 301-851-3300 option 3 for further information if you are unsure as to how to
answer this question.

Question 8, Institutional Biosafety Committee Review/Approval


If an IBC reviews and approves arthropod work with select agents at this facility, check “Yes”
and indicate if the IBC has approved the arthropod containment laboratory design and
operational procedures.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.



If an IBC reviews and approves arthropod work with select agents at this facility but has not
approved the work described in the attachment, provide an explanation for the absence of
review and/or approval.



If an IBC does not review and approve arthropod work with select agents at this facility, check
“No”.
Note: Some corporate or private entities do not have these committees; check “No” if this is
the case.

Question 9, Release Prevention


If arthropods are prevented from release into the suite/room, check “Yes” and indicate if
procedures include a protocol for accidental escape.



Check “Yes” if you have a “room within a room” style vivarium cage that is contained within a
laboratory room, but the arthropods are prevented from accessing the walls or fixtures such as
lights, outlets, etc.



If arthropods are not prevented from release into the suite/room (i.e. they normally have
access to the suite/room walls or wall fixtures), check “No”.
Note: This question relates to the secondary containment design features of the laboratory for
maintenance of arthropods, not active work and manipulation of them or the primary
containment described in Question 5.

Question 10, Infected Arthropod Contact and Release Prevention


If experimentally infected arthropods are manipulated in a suite/room such that accidental
contact and release is prevented, (i.e. within primary containment such as a glove box), check
“Yes”.



If experimentally infected arthropods are not housed and manipulated in a suite/room such
that accidental contact and release is prevented, check “No”.
Note: This question relates primarily to active work and manipulation of arthropods, not
maintenance of them in the insectary as described in Question 5.

Question 11, Ventilation Escape Barriers


Many arthropods have a flighted life stage, and escape through ventilation penetrations of the
insectary, laboratory or containment facility is a concern. If suite/room ventilation filters or other
barriers over the vents and/or doors and wall penetrations are installed to prevent arthropod
escape, check “Yes”.



If ventilation filters/barriers are not installed to prevent arthropod escape, check “No”.



If no, provide additional information as to the method by which you prevent arthropod escape
through the ventilation system (e.g. “no flighted stage, moat and petroleum jelly on rim of pan
used for containment of tick vectors”).

Question 12, Floor Drains


Many arthropods have an aquatic life stage, and escape through plumbing penetrations is a
concern. If floor drains are present in the laboratory, check “Yes” and indicate if the floor drains
are modified to prevent accidental release of arthropods and agents.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.



If floor drains are not present in the laboratory, or there are no modifications to prevent
accidental release of arthropods and agents, check “No”.



If no, provide additional information as to the method by which you prevent arthropod
colonization and escape through the plumbing (e.g. “no aquatic stage, moat and petroleum
jelly on rim of pan used for containment of tick vectors”).

Question 13, Plumbing Escape Barriers


Many arthropods have an aquatic life stage, and escape through plumbing penetrations is a
concern. If suite/room plumbing is suitable to prevent arthropod escape, check “Yes”.



Check “Yes” if you have floor and sink drain modifications and/or downstream plumbing
features that prevent the colonization of the plumbing by arthropods and/or their escape.



If suite/room plumbing is not suitable to prevent arthropod escape (i.e. if there are no plumbing
modifications), check “No”.

Question 14, Disposal


The escape of live arthropods from insectary waste before decontamination is a concern. If all
stages of arthropods are killed before disposal (e.g. through freezing before discarding into
trash that will be autoclaved), check “Yes”.



If all stages of arthropods are not killed before disposal, check “No”.
Note: This question relates to the killing of the arthropod separate from the decontamination
of the agent.

Question 15, Waste Treatment


This question relates to the decontamination of the select agent separate from the killing of the
arthropod. If all wastes from the arthropod containment laboratory are treated for disposal
using an approved method, check “Yes”.



If yes, describe the treatment method(s) by checking all applicable methods and providing
relevant aspects of the method(s) selected for decontamination as appropriate.



If all wastes from the arthropod containment laboratory are not treated for disposal using an
approved method, check “No”.

Question 16, Animals/Plants in Arthropod Containment Laboratory


If animals or plants are permitted in the arthropod containment laboratory, check “Yes” and
complete Questions 16a-b.



If animals or plants are not permitted in the arthropod containment laboratory, check “No”.



For 16a, check “Yes” if the animals or plants allowed in the laboratory are an integral part of
the active work being performed (i.e. they are research animals or plants housed in the
laboratory for other work and are not pets or ornamental plants). Otherwise, check “No”.



For 16b, check “Yes” if the animals or plants are accessible to escaped arthropods (i.e. if there
is normally only one containment barrier between the arthropods and the animals or plants).

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Attachment F - BSL3 Ag Laboratories
This section is used to assess any work which may be performed in BSL3Ag laboratories at an entity.
Complete this section by checking either “Yes” or “No” for all questions and entering additional
information when prompted.
Additional guidance is provided below; if further information or guidance is required, please contact
the CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


PI


Fill out the name of the Principal Investigator(s) for which this attachment is being completed.
Use first initial followed by last name, separate multiple PI names with commas.

Question 1, Supply, Material and Equipment Decontamination


If supplies, material and equipment enter and exit BSL3Ag areas only through an airlock,
fumigation chamber, interlocked and double-door autoclave or shower, check “Yes”.



If supplies, material and equipment enter and exit BSL3Ag areas through other means, check
“No”.



If a gas sterilizer, pass-through liquid dunk tank, or a cold gas decontamination chamber is
provided for temperature sensitive materials, check “Yes”.



If a gas sterilizer, pass-through liquid dunk tank, or a cold gas decontamination chamber is not
provided for temperature sensitive materials, check “No”.

Question 2, Shower


If a shower is required when leaving the containment boundary, check “Yes”.



If a shower is not required when leaving the containment boundary, check “No”.

APHIS/CDC Form 1 Instructions

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Question 3, Disposable Material Decontamination


If disposable materials (e.g., animal waste, carcasses, liquid drainage, personal protective
equipment) are decontaminated by a verified method, check “Yes”.



If yes, describe the treatment method(s) by checking all applicable methods and providing
relevant aspects of the method(s) selected for decontamination as appropriate.



If disposable materials are not decontaminated by a verified method, check “No”.

Question 4, Containment Area Construction


If 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; and all penetrations (including the ductwork) into the laboratory are sealed airtight to
prevent escape of agents and to allow fumigation for biological decontamination, check “Yes”.



If all containment areas are not designed, constructed and verified to function as a primary
containment barrier; all walls are not constructed slab-to-slab and walls, floors, and ceilings
are not sealed; and all penetrations (including the ductwork) into the laboratory are not sealed
airtight to prevent escape of agents and to allow fumigation for biological decontamination,
check “No”.

Question 5, Airflow Monitoring


If differential pressures/directional airflow are monitored and alarmed to indicate system
failure, check “Yes”.



If differential pressures/directional airflow are not monitored and alarmed to indicate system
failure, check “No”.

Question 6, HEPA Filtration


If there is HEPA filtration of all supply and exhaust air to and from the containment space (e.g.,
animal suite/room(s), inner/dirty change room(s), anteroom(s), plumbing exhaust vents), check
“Yes” and indicate if all HEPA filters are certified annually.



If all supply and exhaust air to and from the containment space (e.g., animal suite/room(s),
inner/dirty change room(s), anteroom(s), plumbing exhaust vents) is not HEPA filtered, check
“No”.

Question 7, Laboratory Procedures and Design Features


Describe the BSL3Ag laboratory procedures and design features by completing Questions 7ae.

Question 8, Second Shower


If a second shower is required at the facility access control point before donning street
clothing, check “Yes”.



If a second shower is not required at the facility access control point before donning street
clothing, check “No”.

Question 9, Humane Restraining Devices


If humane restraining devices are provided in large animal rooms, check “Yes” and state what
restraining devices are provided and describe how they will be used.

APHIS/CDC Form 1 Instructions

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Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.



If humane restraining devices are not provided in large animal rooms, check “No”.

Question 10, Large Animal Necropsy Rooms


If necropsy rooms are sized and equipped to accommodate large animals, check “Yes” and
describe these features.



If necropsy rooms are not sized and equipped to accommodate large animals, check “No”.

APHIS/CDC Form 1 Instructions

Version 1.6 January 18, 2017

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Federal Select Agent Program website
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Attachment G - BSL4/ABSL4 Laboratories
This attachment is used to assess work performed in BSL4 or ABSL4 laboratories. Complete this
attachment by checking either “Yes” or “No” for all questions and entering additional information when
prompted.
Additional guidance is provided below; if further information or guidance is required, please contact
the CDC at 404-718-2000 or APHIS at 301-851-3300 option 3.

Header Information
This Submission Is


Entity Name


Provide the complete legal name of your entity (corporation, partnership, sole proprietorship,
etc.) under which operations are conducted.

Date


PI


Fill out the name of the Principal Investigator(s) for which this attachment is being completed.
Use first initial followed by last name, separate multiple PI names with commas.

Question 1, Cabinet Laboratory


If work will be performed in a BSL4/ABSL4 Cabinet Laboratory, check “Yes” and complete
Questions 2-8.



If work will not be performed in a BSL4/ABSL4 Cabinet Laboratory, check “No” and skip to
question 9.

Question 2, Personal Protective Equipment (Cabinet Laboratory)


Describe the type of personal protective equipment that will be used.

Question 3, Decontamination Methods (Cabinet Laboratory)


Describe the decontamination methods for materials/equipment in the Class III cabinet.

Question 4, Liquid Effluent Decontamination (Cabinet Laboratory)


Describe what liquid effluents are decontaminated and how they are decontaminated.

APHIS/CDC Form 1 Instructions

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Federal Select Agent Program website
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Question 5, Room Ventilation (Cabinet Laboratory)


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.

Question 6, Ventilation Failure (Cabinet Laboratory)


In the event of a ventilation failure, describe what measures are used to prevent reversal of
airflow.

Question 7, Airflow Monitoring (Cabinet Laboratory)


Describe how differential pressures and directional airflow are monitored and analyzed.

Question 8, Containment Parameters Monitoring (Cabinet Laboratory)


Describe how containment parameters are monitored daily.

Question 9, Suit Laboratory


If work will be performed in a BSL4/ABSL4 Suit Laboratory, check “Yes” and complete
Questions 10-16.

Question 10, Personal Protective Equipment (Suit Laboratory)


Describe the type of personal protective equipment that will be used.

Question 11, Liquid Effluent Decontamination (Suit Laboratory)


Describe what liquid effluents are decontaminated and what measures are used.

Question 12, Room Ventilation (Suit Laboratory)


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

Question 13, Ventilation Failure (Suit Laboratory)


In the event of a ventilation failure, describe what measures are used to prevent reversal of
airflow.

Question 14, Airflow Monitoring (Suit Laboratory)


Describe how differential pressures and directional airflow are monitored and analyzed.

Question 15, Breathing Air Failure (Suit Laboratory)


Describe what facility redundancies are in place in the event of a breathing air failure.

Question 16, Containment Parameters Monitoring (Suit Laboratory)


Describe how containment parameters are monitored daily.

APHIS/CDC Form 1 Instructions

101

Version 1.6 January 18, 2017

When using this document, first verify that it is the current version available on the
Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Amendment Requirements
These instructions are intended to provide a list of the documentation the FSAP will need to process
the most frequent registration changes.
An Amendment is defined as a request to update a registered entity’s Certificate of Registration for
Possession, Use and Transfer of Select Agents and Toxins (APHIS/CDC Form 1). An amendment is
considered pending until final approval has officially been communicated to the entity via the FSAP.
Approval is required before implementing the changes requested in the amendment.
In some cases, an Amendment Update will be requested by the FSAP in order to obtain clarification
and/or additional information for an existing, pending amendment.
Amendment submissions from a registered entity may or may not require the submission of updated
pages or sections of the APHIS/CDC Form 1. For example, the removal of a laboratorian requires a
written request only from the Responsible Official (RO) or an Alternate Responsible Official (ARO).
Other changes, such as the addition of a new select agent/toxin or suite/room, will require multiple
sections of APHIS/CDC Form 1 to be updated.
Separate Amendment Requests to Help the Federal Select Agent Program Approve
Amendments in a Timely Manner
The FSAP will not approve an amendment request until it has reviewed and found all of the
documentation submitted as part of the request to be sufficient.
For example, if an entity submits a request to add a new laboratory room and to modify its objectives
of work for a select agent or toxin currently on its registration as part of the same amendment, the
FSAP will not approve the amendment until it has reviewed and found the documentation for both of
these changes to be sufficient, including inspecting the new room and finding the inspection report to
be satisfactory. Therefore, an entity can assist the FSAP in processing requests for distinct changes
to its registration by submitting these requests as separate amendments.
Example: A registered entity is adding two new laboratory rooms (Rooms A and B) to their
registration for work with a select agent currently on the registration. The addition of these rooms has
also resulted in 2 new staff being hired (Jane Doe and John Smith). John Wilson has also recently
retired.
Preferred submission of separate amendments:
Amendment 1 – Add John Smith and Jane Doe
Amendment 2 – Remove John Wilson
Amendment 3 – Add Rooms A and B
Note: Send your amendment documentation only once. For example, if you email your amendment
documentation to your designated FSAP representative, you do not need to fax a duplicate copy.

Amendment Request
All amendments and amendment updates submitted to the FSAP should contain a request which
details the changes to be made. The request can be made in the form of a cover letter signed by the
RO or an ARO or as an email sent from the RO or an ARO’s email account on file. Registered entities
are also urged to use their FSAP Application Number (ex. CDC050555) within the request in order to
help route documents efficiently.
Requests should be as descriptive as possible. Requests that do not clearly explain the changes
to be made to your registration or conflict with the forms submitted may require the
submission of additional documentation and result in delayed approval of your amendment
request. Any changes made to your APHIS/CDC Form 1 must be contained in a request. If a
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cover letter is used, it should be written on official letterhead or have other characteristics which
clearly indicate the origin of the request.

Examples of Request Language
Request language should be as descriptive as possible and reference the sections of the APHIS/CDC
Form 1 being updated. Although providing a DOJ number is not required to remove an individual,
doing so will increase the accuracy of the requested actions and the speed at which the amendment
is approved.
The examples below are intended to represent some of the most frequent amendment requests
submitted by registered entities:


Please remove John Smith (C-JS-000000) from our registration. John Smith has voluntarily
terminated employment at our facility to pursue a graduate degree.



Please add Mike Smith to our registration as a laboratorian under PI Andrews, see attached
Section 4A. Mr. Smith will not have access to Tier 1 agents.



Please update Mike Smith’s (C-MS-000000) role to ARO. Mike Smith is currently security risk
assessment (SRA) approved at our entity and has an assigned role of laboratorian. Updated
Sections 1A and 1B including Mr. Smith are attached.



Please remove rooms 101, 102, 103 and 104 from Principal Investigator (PI) Jones. These
rooms will continue to be used by other PIs and should not be removed from our overall
registration. PI Jones inventory has been audited and has been relocated to laboratory room
105, currently approved for PI Jones.



Please remove BSL3 rooms 205, 206, and 208 from our registration. See attached Section 7
for PI Cheng and PI Anderson with these rooms removed. All select agents have been
reconciled and transferred to long-term storage in room 315. Rooms 205, 206, 208 have been
decontaminated with vaporized hydrogen peroxide (VHP) performed by a contracted vendor.
See attached documentation of decontamination procedures.



Please remove PI Williams (C-MW-000000) from our registration. PI Williams has accepted a
position at another university, effective date January 1, 2013. See the attached Section 7 for
co-PIs Williams and Johnson with PI Williams’ name removed from Section 7A and
Attachment headers and a Section 4A assigning laboratorians to PI Johnson only.



Please remove Bacillus anthracis from our registration. All B. anthracis stocks and working
samples have been reconciled, autoclaved, and the destruction witnessed by the RO and PI
Smith. See the attached Section 3 with B. anthracis removed, PI Smith’s Section 7 with her
work objectives updated and B. anthracis removed, and documentation of destruction
(autoclave records) with witness signatures.



Please add Bacillus anthracis to our registration. Attached is documentation delineating facility
improvements to achieve BSL3 standards for our registered laboratory as well as updated
Sections 3, 6 and 7.



Please add Francisella tularensis to our registration. We are also requesting to perform a
restricted experiment with Francisella tularensis. Attached are updated Sections 3 and 7 and
Attachment B describing the proposed restricted experiment.



We have conducted a quarterly review of our inventory and would like to update our strain
information on file with the FSAP. See the attached Section 7B for each registered PI.



Principle Investigator John Doe (C-JD-000000) recently received grant funding to develop
Burkholderia mallei rapid detection methodologies. Dr. Doe will work with Burkholderia mallei

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in BSL3 laboratory rooms 100 and 101. Please see the updated Sections 3, 4A, 6, and 7
adding Burkholderia mallei, PI Doe’s laboratory staff, rooms 100 and 101, and PI Doe to our
registration. Dr. Doe and his staff will have access to Tier 1 select agents as indicated on
Sections 4A and 7A.


Jane Rogers (C-JR-000000) will no longer have the ability to access Tier 1 select agents and
toxins but will continue to work with non-Tier 1 select agents. Please update her status to
remove Tier 1 Access as indicated on the attached Section 4A.

Federal Select Agent Program Concurrence
CDC and APHIS work together to provide a single point of contact. This single point of contact is
referred to as the “lead agency”, and as such, is responsible for coordinating all activities and
communications with respect to your registration, including coordination with the non-lead agency.
An amendment to the registration which concerns a select agent or toxin not regulated by your lead
agency will require concurrence from the non-lead agency. In these instances, you may be required to
submit additional documentation. The FSAP will initiate the concurrence process and all
correspondence will be directed through your designated representative. Amendments requiring
concurrence may require additional time for processing and review.

Amendment Submission
Submit the required documentation to your designated FSAP representative. Upon receipt of the
amendment, a confirmation letter with the assigned amendment number will be faxed to the number
currently on file for the RO. Subsequent communications with the FSAP regarding this request should
include the assigned amendment number.


The FSAP encourages entities to communicate any amendments or amendment updates via
email to their designated FSAP representative. Emails from other personnel at the entity (ex.
Administrative Staff) will be accepted if a cover letter signed by the RO or ARO is attached.



Electronic versions (.doc, .xls, .pdf) of the approved forms or scanned images of the cover
letter and APHIS/CDC Form1 sections may be attached to an email in lieu of faxing or mailing
the documentation.



All electronically submitted APHIS/CDC Form 1 sections must have the required signatures.
Digital/electronic signatures are accepted.



An email may serve as the request provided it includes all required information and is sent
from the email address on file for the RO or ARO.



Amendments and amendment updates can also be faxed or mailed.

The amendment will be processed for approval following the submission of sufficient documentation
and, if applicable, pending satisfactory closure of an inspection. The entity will receive notification
from the FSAP once the amendment has been approved.
If you have any questions about the amendment process, these examples or any other types
of amendments, contact your designated FSAP representative.

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Amendment Reference Table
Request

Sections
1A-C

Section
2

State changes (a)

Updated
1A, 1B

Updated
(RO only)

State changes (a)

Updated 1A

Amendment type
Personnel
Addition/Reactivation RO
Addition/Reactivation ARO
Addition/Reactivation
Owner/Controllers
Addition/Reactivation of
Laboratorian, Animal Care
Staff
Addition/Reactivation of
Support Staff
Addition/Reactivation of
Unescorted Visitor

State changes
(name, role) and (a)

State changes (a)

Removal of RO or ARO

Reason for removal.
New RO must be
appointed.

Removal of
Owner/Controller
Removal of Personnel:
Laboratorian, Animal Care
Staff, Support Staff, Visitor

Sections
4 A-C

Sections
5A-D

Sections
6A-6B

Updated 4A

State changes
(name, role) (a)
State changes
(name). Signed letter
from RO at home
entity.

Addition/Reactivation of PI

Section
3

Sections 7A-7C
(including Attachments)

Updated 7C if responsible for
inventory

Updated 4B

Updated 4C
Updated
4A, 4C as
applicable
Updated 1A,
1B

Section 7 for new PI

Updated
(RO only)

Reason for removal
Updated 7C if responsible for
inventory

Reason for removal

Removal of PI

State disposition of
agents, reason for
removal.

Updated
4A, 4C as
applicable

Updates to Names, Titles or
Supervising PI for
Laboratorian, Animal Care
Staff, Support Staff,
Unescorted Visitor

State changes

Updated
4A, 4B, 4C as
applicable

Updates to PI Name

State changes

Updated
4A, 4C as
applicable

Updated 7A; updated headers
for 7B, 7C and attachments

Updates to RO/ARO/Owner
Controller Name or Contact
Information

State changes

Updates to Tier 1 access

State changes and
reason for change

Updated
4A, 4B, 4C as
applicable

Updated 7A as applicable

(a) Requires SRA Approval

APHIS/CDC Form 1 Instructions

Updated 1A;
1B for name
change only
Updated
1A, 1B as
applicable

(b) Inspection may be required

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Updated Section 7 if a co PI

Amendment type

Sections
1A-C

Request

Section
2

Section
3

Sections
4 A-C

Sections
5A-D

Sections
6A-6B

Sections 7A-7C
(including Attachments)

Select Agent/Toxin
Addition of Agent or Toxin
Addition of Tier 1 Agent or
Toxin

Consider BSL of
work, agent/toxin,
laboratory (b)
Consider BSL of
work, agent/toxin,
laboratory (b)

Updated for each PI adding
agent/toxin

Updated
Updated 1A, as
applicable

Updated

Updated 4A,
4B, 4C as
applicable

Updated 5A,
5B as
applicable

Updated 6A for
affected
suite/room

Updated 7A and 7C for each PI
adding agent/toxin

Update Possession Status of
Select Agents/Toxins
Removal of Agent or Toxin
from Entity
Removal of Agent or Toxin
from PI (but not Entity)

State disposition of
agent/toxin
State disposition of
agent/toxin

Addition of New Work

State changes (b)

Removal of Work

State changes

Updated for PI removing work

Strain Update

State changes

Updated 7B for each PI

State changes

Updated 7B for each affected
PI upon possession
Updated for each PI registered
for agent/toxin
Updated for each PI registered
for agent/toxin
Updated 7C for PI adding new
work

Updated
Updated

Facility
Section 6 for
each suite/
room added
and floor plan

Addition of Suite/Room

State changes (b)

Removal of Suite/Room

State disposition of
agents, decon of
suite/room

Update to Building and
Suite/Room Specific Security

State changes

Update to Suite/Room
Physical Information

State changes

Other
Entity Name or Address
Changes
Update to Entity Institutional
Mission, Function and/or Size
Update to Entity Wide
Security
Update to Entity-Wide
Biosafety/Biocontainment
Update to Entity Entry
Requirements for FSAP
Inspectors

Updated 7A for
each affected PI
Updated 6A for
affected
suite/room
Updated 6B for
affected
suite/room

Explanation of
changes

Updated 1A

State changes

Updated 1C

State changes

Updated 5A

State changes

Updated 5B

State changes

Updated 5C

(a) Requires SRA Approval

APHIS/CDC Form 1 Instructions

Updated 7A for each PI to store
and/or work in the new
suite/room

(b) Inspection may be required

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Personnel Amendments
Adding Individuals – General Information
When submitting an amendment to add new individuals to your registration, submit documentation for
only those specific individuals being added. To validate your personnel records against those
maintained by the FSAP you may periodically (e.g., quarterly) request a comprehensive DOJ List for
your entity. The DOJ List will include all individuals, their DOJ Number, their current SRA status, and
their SRA expiration date.


The first and last name for each individual should match that which is entered in Block 4 on
his/ her respective FD-961 Form.



Upon receipt of your request, a DOJ Number will be provided for each individual to enter in
Block 3 on his/her FD-961 form. The DOJ Numbers for all individuals added within an
amendment will be sent to the RO in a DOJ Number Assignment Letter.



SRA approval must be granted for every individual added within the amendment before the
amendment is approved. However, an individual’s access to select agents/toxins is granted
upon receipt of the SRA Approval Letter (not the DOJ Number Assignment Letter) sent directly
to the RO for each approved individual.



Once assigned at an entity, an individual’s DOJ number at that entity will not change.




When entering an individual’s DOJ number, capitalize the letters as in A-XX-123456 or C-AA000000.



For individuals currently registered at another entity (active SRA), the entity will follow the
same procedure for requesting to add a new individual to the registration. The individual will
be assigned a new DOJ number associated with their registration at the new entity.
o

Do not submit an FD-961 form, fingerprints or photograph to the FBI/CJIS. Once the
existing SRA is verified, a Notice of SRA Approval for Access to Select Agents and/or
Toxins letter will be sent to the requesting entity.

The SRA expiration date will be the same at all entities. The date will be based on the
current expiration date and not three years from the time of approval at the second
entity. For example, J. Doe is registered at Entity A with an SRA expiration date of May
15, 2017. When J. Doe registers at Entity B with access approval granted on October
17, 2016, his SRA expiration date for both entities will be May 15, 2017.

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Adding or Reactivating a RO
The RO is the individual designated by an entity with the authority and responsibility to ensure
compliance with the Select Agent Regulations.
Note: A new RO cannot self-appoint (i.e., a currently registered ARO cannot sign paperwork
requesting to be the RO). When possible, the RO should send an amendment to appoint his/her
successor. If the RO has already left the entity, the new RO must be appointed by an owner,
controller or person of authority at the entity.
To add or reactivate a RO, submit the following documentation:

□

Request stating the name of the RO to be added or reactivated.


□

Complete Section 1A (with the newly appointed RO).


□
□

The request should be made by the current, approved RO who will be replaced.
For reactivations, use the RO’s previously assigned DOJ number in the DOJ Number
box.

Complete Section 1B signed by the newly appointed RO and each ARO.
Complete Section 2 completed by the newly appointed RO.
Additional Information


By initialing each line on Section 2, the RO is certifying that as of the date
indicated on the amendment submitted to the FSAP that all information is current
and accurate and these requirements are met. This includes ensuring that plans
are written and provisions and procedures described are in effect at the time of
submission of the registration amendment in accordance with the requirements
of the Select Agent Regulations.



Since all communication between a registering individual or entity and the FSAP
is through the RO or ARO, it is imperative that the RO and ARO contact
information is kept current and accurate. If any Section 1A information changes,
it must be immediately reported to the FSAP. Verbal change requests cannot be
accepted.



A Curriculum Vitae for the RO may be requested.

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Adding or Reactivating an ARO
The ARO is the individual designated by an entity with the authority and responsibility to ensure
compliance with the Select Agent Regulations when acting as the RO.
Note: A new ARO cannot self-appoint (i.e., a currently registered laboratorian cannot submit an
amendment requesting to be an ARO). An ARO must be designated by the current RO.
To add or reactivate an ARO, submit the following documentation:

□
□

Request stating the name of the ARO to be added or reactivated.
Complete Section 1A (including the newly appointed ARO).


□

For reactivations, use the ARO’s previously assigned DOJ number in the DOJ Number
box.

Complete Section 1B signed by the RO and each ARO (including the newly appointed ARO).
Additional Information


Since all communication between a registering individual or entity and the FSAP
is through the RO or ARO, it is imperative that the RO and ARO contact
information is kept current and accurate. If any Section 1A information changes,
it must immediately be reported to the FSAP. Verbal change requests cannot be
accepted.



It is recommended that an entity have at least one ARO to ensure continuity of
operations.



Once an individual is SRA approved, his/her DOJ number must be included on
Section 1, 4, or 7 as applicable (e.g., if updating the individual’s job title).



An individual is deactivated upon the request to remove the individual. In the
event that an individual requires access approval in the future, the entity may
request to reactivate the individual. Reactivated individuals will use their
previously assigned DOJ number, and this number must be included in Section
1, 4, or 7 as applicable.

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Addition or Reactivation of Owner/Controllers
To add or reactivate an Owner/Controller, submit the following documentation:

□
□

Request stating the name of the Owner/Controller to be added or reactivated.
Complete Section 1A (including the newly appointed Owner/Controller).


For reactivations, use the individual’s previously assigned DOJ number in the DOJ
Number box.

Additional Information


Once an individual is SRA approved, his/her DOJ number must be included on
Section 1, 4, or 7 as applicable (e.g., if updating the individual’s job title).



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Addition or Reactivation of Laboratorians or Animal Care Staff
To add or reactivate non-visiting Laboratorians or Animal Care Staff, submit the following
documentation:

□
□

Request stating the name of the individual to be added or reactivated.
Manually or electronically signed and dated Section 4A with the individual being added or
reactivated.


□

For reactivations, use the individual’s previously assigned DOJ number in the DOJ
Unique Identifier Number column.

Complete Section 7C if the individual will be responsible for inventory.

Additional Information


Once an individual is SRA approved, his/her DOJ number must be included on
Section 1, 4, or 7 as applicable (e.g., if updating the individual’s job title).



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Addition or Reactivation of Support Staff
To add or reactivate Support Staff, submit the following documentation:

□
□

Request stating the name of the individual to be added or reactivated.
Manually or electronically signed and dated Section 4B with the individual being added or
reactivated.


For reactivations, use the individual’s previously assigned DOJ number in the DOJ
Unique Identifier Number column.
Additional Information



Once an individual is SRA approved, his/her DOJ number must be included on
Section 1, 4, or 7 as applicable (e.g., if updating the individual’s job title).



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Addition or Reactivation of Unescorted Visitors
Unescorted visitors are defined as those individuals with SRA approval at a registered entity (Home
Entity) who wish to visit another registered entity (Host Entity) for the purpose of having access to
and/or conducting work with select agents or toxins at the host entity. When an unescorted individual
is added, they do not require submission of a new FD-961, fingerprints or additional SRA approval at
the Host Entity. To add an unescorted visitor to your registration, additional information is needed
beyond that for a routine addition of personnel.
Note: Visitors who are continually escorted as described in section 11(d)(2) of the Select Agent
Regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331) do not require the documentation
below, as they will not have access to, and/or conduct work with, select agents or toxins.
To add an unescorted visitor, the Host Entity must submit the following documentation:

□
□

□

Request stating the name of the individual to be added as an unescorted visitor.
Signed letter from the RO at the individual’s Home Entity which includes the following:


Affirmation that the individual will be visiting the entity



Name of the individual



Individuals’ date of birth



Individual’s DOJ number at his/her Home Entity



Individual’s SRA approval date at his/her Home Entity



Information regarding Tier 1 suitability assessment of individual, if applicable

Manually or electronically signed and dated Section 4C for the individual being added as an
unescorted visitor.
Additional Information


Upon receipt of your request, a host DOJ number will be provided for each
unescorted visitor listed. Unescorted visitors will NOT submit a FD-961 form
using this host DOJ Number.



Once the visit is complete, a request to remove the individual will be submitted.
See the Removal of Laboratorians, Animal Care Staff, Support Staff, and
Unescorted Visitors for further information.

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Addition or Reactivation of a PI
Each PI must have at least one select agent/toxin/regulated nucleic acids and at least one suite/room
listed on his/her Section 7A. Provide a separate Section 7 for each new PI added or reactivated.
To add or reactivate a PI, submit the following documentation:

□

Request stating the name of the PI to be added or reactivated, brief summary of the
suites/rooms, select agents/toxins/regulated nucleic acids, and work objectives for this PI.

□

Manually or digitally signed and dated Section 4A and/or Section 4C to include all staff
assigned to this PI.


□

□
□

If a previously submitted Section 4A or 4C indicated “All PIs” in the supervising PI
column, then no Section 4 update for the individuals affected is required.

Complete Section 7.


For reactivations, use the individual’s previously assigned DOJ Number in the DOJ
Number box.



If multiple PIs conduct identical work with select agents and toxins, they may be listed
on one Section 7.

If a suite/room will be added to the entity registration for this PI, see Addition of a Suite/Room.
If a select agent or toxin will be added to the entity registration for this PI, see Addition of
Select Agent/Toxin.
Additional Information


A PI is an individual designated by the entity to direct a project or program and
who is responsible to the entity for the scientific and technical direction of that
project or program, as defined in section 1 of the Select Agent Regulations.



A Curriculum Vitae for the PI may be requested.

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Removal of RO, ARO, or Owner/Controller
A RO or a sole Owner/Controller cannot be removed without a replacement being appointed.
To remove an RO, submit the following documentation:
The RO must submit an amendment to appoint his/her successor. If circumstances prevent this, the
new RO must be appointed by an owner, controller or person of authority at the entity. Removal of an
ARO does not require a replacement.

□

Request stating the name of the RO to be removed and the reason for removal.
Note: If you are cancelling a request to add an individual in a pending amendment, submit an
update to the amendment in which the initial request was made. (Example: John Smith was
requested to be added in Amendment 123456 and subsequently took a different position prior
to the amendment being approved. The request to remove John Smith would be submitted as
an UPDATE to Amendment 123456.)

□

Designate a new RO, see Adding or Reactivating a RO.


Complete Section 1A with the new RO’s information.



Complete Section 1B.



Complete Section 2 to be completed by the new RO.

If the departing RO is also a PI, see Removal of a PI.

Additional Information


In the event that an entity loses the services of its RO, it may continue to
possess, use, or transfer select agents or toxins only if it appoints another
individual as the RO, who meets the requirements of the regulations, and who
has been approved by the APHIS Administrator or HHS Secretary following a
security risk assessment by the Attorney General.

To remove an ARO, submit the following documentation:

□

Request stating the name of the ARO to be removed and the reason for removal.
Note: If you are cancelling a request to add an individual in a pending amendment, submit an
update to the amendment in which the initial request was made. (Example: John Smith was
requested to be added in Amendment 123456 and subsequently took a different position prior
to the amendment being approved. The request to remove John Smith would be submitted as
an UPDATE to Amendment 123456.)

□
□

Complete Section 1A with the departing ARO’s information removed.
Complete Section 1B.


If designating a new ARO, see Adding or Reactivating an ARO.



If the departing ARO is also a PI, see Removal of a PI.

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To remove an Owner/Controller, submit the following documentation:

□

Request stating the name of the Owner/Controller to be removed and the reason for removal.
Note: If you are cancelling a request to add an individual in a pending amendment, submit an
update to the amendment in which the initial request was made. (Example: John Smith was
requested to be added in Amendment 123456 and subsequently took a different position prior
to the amendment being approved. The request to remove John Smith would be submitted as
an UPDATE to Amendment 123456.)


If designating a new Owner/Controller, see Addition or Reactivation of
Owner/Controllers.



If the departing Owner/Controller is also a PI, see Removal of a PI.
Additional Information



In the event that an entity loses the services of its sole Owner/Controller, it may
continue to possess, use, or transfer select agents or toxins only if it appoints
another individual as the Owner/Controller, who meets the requirements of the
regulations, and who has been approved by the APHIS Administrator or HHS
Secretary following a security risk assessment by the Attorney General.

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Removal of Laboratorians, Animal Care Staff, Support Staff, and Unescorted Visitors
To remove personnel (excluding a PI, RO, or ARO), submit the following documentation:

□

Request stating the name of the individual to be removed and the reason for removal.
Note: If you are cancelling a request to add an individual in a pending amendment, submit an
update to the amendment in which the initial request was made. (Example: John Smith was
requested to be added in Amendment 123456 and subsequently took a different position prior
to the amendment being approved. The request to remove John Smith would be submitted as
an UPDATE to Amendment 123456.)
Additional Information


Do not include the names of removed individuals on future Sections 1, 4, or 7
submissions.



Once the individual is removed, he/she will be deactivated from the entity’s
registration. If the individual requires access approval in the future, the individual
may be reactivated at that time. See the Addition or Reactivation of
Laboratorians or Animal Care Staff as appropriate.

APHIS/CDC Form 1 Instructions

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Version 1.6 January 18, 2017

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Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Removal of a PI
The removal of a PI requires additional documentation to account for the disposition of any inventory
of select agents and/or toxins. It is important for entities to consider how the removal of a PI may
affect other aspects of their registration (e.g., if the PI was the only PI assigned to a select agent/toxin,
suite/room, laboratorian) and submit updates to appropriate sections of APHIS/CDC Form 1 as
needed.
To remove a PI, submit the following documentation:

□

Disposition of the PI’s select agent(s) and/or toxin(s)


□

Destroyed – Provide documentation of destruction (e.g., autoclave records and
statement signed by witness)

Transferred – For transfers to another registered entity, provide the
APHIS/CDC Form 2 transfer number (ex. CEA123456). For intra-entity
transfers, provide chain of custody documentation.

If the entity is removing a select toxin from its registration, but will continue to possess the
select toxin under the regulated aggregate amount,


Statement and/or records showing that the amount of toxin possessed by the
registered PI is under the regulated aggregate amount.



Statement of how the entity will ensure that each PI’s select toxin inventory remains
below the regulated aggregate amount.

If the departing PI is assigned staff at the entity, an updated and manually or digitally signed
Section 4A and/or Section 4C must be submitted as appropriate with the supervising PI
column updated (e.g., staff reassigned to other PIs).


□

Verification of inventory audit.

If a previously submitted Section 4A or 4C indicated “All PIs” in the supervising PI
column, then no Section 4 update for the individuals affected is required.

If the departing PI is listed on the same Section 7 as another PI remaining on the registration
(e.g., co-PIs), an updated Section 7 with the departing PI information removed is required.


If a suite/room will be removed, see Removal of Suite/Room.



If the departing PI is also an RO or ARO, see Removal of RO, ARO, or
Owner/Controller.

APHIS/CDC Form 1 Instructions

118

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Destroy obsolete versions unless retained as a historical record.

Additional Information


Each select agent/toxin, suite/room, laboratorian, animal care staff, and
unescorted visitor must be assigned to a designated PI.



An approved APHIS/CDC Form 2 is required prior to the transfer of select agents
and/or toxins to another registered entity.



Entities must conduct inventory audits of all affected select agents and toxins in
long-term storage per section 11(e) of the Select Agent Regulations (42 CFR
Part 73, 9 CFR Part 121, and 7 CFR Part 331) when any of the following occur:
(1) Upon the physical relocation of a collection or inventory of select agents or
toxins for those select agents or toxins in the collection or inventory;
(2) Upon the departure or arrival of a principal investigator for those select agents
and toxins under the control of that principal investigator; or
(3) In the event of a theft or loss of a select agent or toxin, all select agents and
toxins under the control of that principal investigator.
For additional information on inventory audits, refer to the Security Guidance for
Select Agent or Toxin Facilities.

APHIS/CDC Form 1 Instructions

119

Version 1.6 January 18, 2017

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Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Update to Names, Titles or Supervising PI for Laboratorians, Animal Care
Staff, Support Staff, and Visitors
In the event that an individual changes their name, title, or is assigned to a new supervising PI, a new
Section 4 (4A, 4B, or 4C as appropriate) for that individual should be submitted to the FSAP.
Note: Only laboratorians, animal care staff, and unescorted visitors require a supervising PI.
To update a name, title, or supervising PI submit the following documentation:

□
□

Request stating the name of the individual to be updated and update to be made.
Manually or digitally signed and dated Section 4 for the individual which includes the updated
information.


Section 4A – Laboratorians and Animal Care Staff



Section 4B – Support Staff



Section 4C – Unescorted Visitors
Additional Information



A name change does not affect an individual’s DOJ Number. Individuals who
change their name should continue to use the same DOJ number for any future
FD-961 or APHIS/CDC Form 1 submissions.

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120

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Destroy obsolete versions unless retained as a historical record.

Update to PI Name
To update a PI’s name, submit the following documentation:

□
□

Request stating the current name and the updated name of the PI.
If the PI is assigned staff at the entity, an updated and manually or digitally signed Section 4A
and/or Section 4C as appropriate with the supervising PI column updated.


□

If a previously submitted Section 4A or 4C listed “ALL PI(s)” in the supervising PI
column, then no Section 4 update for those individuals is required.

Updated Section 7 with Section 7A and all headers, including attachments as applicable,
updated.
Additional Information


A name change does not affect the DOJ Number assigned to an individual.
Individuals who change their name should continue to use the same DOJ
number for any future FD-961 or APHIS/CDC Form 1 submissions.

APHIS/CDC Form 1 Instructions

121

Version 1.6 January 18, 2017

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Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Update to RO, ARO or Owner/Controller Name or Contact Information
Entities must ensure that the FSAP has the most up-to-date contact information for the RO and each
ARO. This contact information is used to communicate directly with the RO/ARO and to send SA
Grams (important program updates and other information). Contact information includes mailing
address, phone numbers, fax numbers and email addresses.
To update RO or ARO contact information, submit the following documentation:

□
□

Request stating the RO/ARO information to be updated.
Complete Section 1A with updated information.

If the RO, ARO, or Owner/Controller name has changed, submit the following documentation:

□
□
□

Request stating the RO, ARO, or Owner/Controller information to be updated.
Complete Section 1A with updated information.
Manually or digitally signed Section 1B.

Additional Information




A name change does not affect the DOJ Number assigned to an individual.
Individuals who change their name should continue to use the same DOJ
Number for any future FD-961 or APHIS/CDC Form 1 submissions.

APHIS/CDC Form 1 Instructions

122

Version 1.6 January 18, 2017

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Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Update to an Individual’s Access to Tier 1 Agents/Toxin
Each individual who will have access, or the ability to access, Tier 1 agents must indicate this by
checking the Tier 1 access box. Several circumstances may require updating an individual’s Tier 1
access status including, but not limited to, the following:





Change in work assignment
Addition or removal of select agent/toxin
Addition or removal of suite/room
Personnel pre-access suitability assessment or ongoing suitability monitoring decisions

Note: A change in Tier 1 access does not add or remove an individual from the entity’s registration.
To update Tier 1 access for an RO, ARO, or Owner/Controller, submit the following
documentation:

□
□
□

Request stating the RO/ARO information to be updated.
Complete Section 1A with updated Tier 1 status information.
Manually or digitally signed Section 1B.

To update Tier 1 access for Laboratorians, Animal Care Staff, Support Staff or Unescorted
Visitors, submit the following documentation:

□
□

Request stating the name of the individual to be updated.
Manually or digitally signed and dated Section 4 for the individual which includes the updated
Tier 1 access information.


Section 4A – Laboratorians and Animal Care Staff



Section 4B – Support Staff



Section 4C – Unescorted Visitors

To update Tier 1 access for a Principal Investigator, submit the following documentation:

□
□

Request stating the name of the PI to be updated.
Updated Section 7A which includes the updated Tier 1 access information.

APHIS/CDC Form 1 Instructions

123

Version 1.6 January 18, 2017

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Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Select Agent/Toxin Amendments
Addition of Select Agent/Toxin
The biosafety level of the laboratory where the select agent/toxin will be used should be consistent
with the BMBL guidelines. An inspection may be required prior to approval.
To add a select agent/toxin, submit the following documentation:
Note: If you are adding a Tier 1 agent for the first time, see Addition of Tier 1 Select Agent/Toxin
below:

□
□

Request specifying all changes.
A comprehensive Section 3 that lists all the select agents/toxins for which the entity wants to
be registered.


□

Complete Section 7A listing all agents and locations for each PI that is affected by this change
for the first submission only.


□

Check the “check if possessed” box only if you currently possess the select
agent/toxin.

A partial Section 7A will be submitted for subsequent amendment submission.

Complete Section 7C that includes all pending and approved select agents/toxins for each PI
that is affected by this change.


New Section 7 Attachments may be required based on work with the new select
agent/toxin.

Note: If you are adding SARS-CoV to the registration, submission of the entity’s occupational health
plan is required. See Recommendation of Guidelines for Medical Surveillance of Laboratory
Personnel Working with SARS-CoV.

Addition of Tier 1 Select Agent/Toxin
To add a Tier 1 select agent/toxin at an entity not currently registered for Tier 1 select
agents/toxins, submit the following documentation:

□
□
□

Request specifying all changes.
Section 1 (as applicable) to indicate Tier 1 access
A comprehensive Section 3 that lists all the select agent/toxin for which the entity wants to be
registered.


□

Check the “check if possessed” box only if you currently possess the select
agent/toxin.

Partial Section 4A, Section 4B, and Section 4C (as applicable) to indicate Tier 1 access.

APHIS/CDC Form 1 Instructions

124

Version 1.6 January 18, 2017

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□

Complete Section 5A (as applicable) that includes additional security features for the building
where Tier 1 select agents/toxins will be used or stored and information on the entity’s
personnel suitability program.

□
□

Complete Section 5B that includes information on the entity’s occupational health program.

□

Complete Section 7A listing all agents and locations for each PI that is affected by this change
for the first submission only.

Complete Section 6A that includes security information specific to the suite/room where Tier 1
select agents/toxins will be used or stored.



□

Complete Section 7C that includes all pending and approved select agents/toxins for each PI
that is affected by this change.


□
□

A partial Section 7A will be submitted for subsequent amendment submission.

New Section 7 Attachments may be required based on work with the new select
agent/toxin.

Security plan
Occupational Health Plan

Note: Depending on the agent(s)/toxin added and the scope of work, an inspection may be required
before final amendment approval


If a suite/room will be added for the new select agents/toxins, see Addition of a
Suite/Room.
Additional Information



The addition of a select agent or toxin requires that written plans, as applicable,
are commensurate with the risk of the agent or toxin given its intended use. This
includes ensuring that plans are updated and provisions and procedures
described are in effect as of the date that the amendment is submitted in
accordance with the requirements of the Select Agent Regulations.



For additional requirements for Tier 1 select agents and toxins, refer to sections
11(f), 12(d), 14(e), and 15(b) of the Select Agent Regulations (42 CFR Part 73, 9
CFR Part 121, and 7 CFR Part 331).



Reconstructed 1918 Influenza Virus requires special consideration and/or
approval. Contact your designated FSAP representative prior to your amendment
submission.

APHIS/CDC Form 1 Instructions

125

Version 1.6 January 18, 2017

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Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Update Possession Status of Select Agents/Toxins
To update the possession status of a select agent/toxin, submit the following documentation:

□
□

Request specifying all changes.
Partial Section 3 that lists only the select agent/toxin to be updated.


□

Check the “check if possessed” box only if you currently possess the select
agent/toxin.

Upon possession, updated Section 7B for each affected PI.

Note: The registration is to be updated within 7 days of a change in the entity’s possession status of
a select agent or toxin.

APHIS/CDC Form 1 Instructions

126

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Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Removal of Select Agent/Toxin from the Entity
To remove a select agent/toxin from the entity, submit the following documentation:

□
□

Request specifying the select agent/toxin to be removed.
Disposition of select agent/toxin


□

Verification of inventory audit.
o

Destroyed – Provide documentation of destruction (e.g., autoclave records and
statement signed by witness)

Transferred – Provide the APHIS/CDC Form 2 transfer number from when
select agents/toxins were transferred to a different registered entity (ex.
CEA123456).

If the entity is removing a select toxin from its registration, but will continue to possess the
select toxin under the regulated aggregate amount,


Statement and/or records showing that the amount of toxin possessed by the
registered PI is under the regulated aggregate amount.



Statement of how the entity will ensure that each PI’s select toxin inventory remains
below the regulated aggregate amount.

□
□

Section 3 with all select agents/toxins for which the entity will remain registered.

□

Complete Section 7C that removes the requested select agent/toxin for each PI that is affected
by this change.

Complete Section 7A that removes the requested select agent/toxin for each PI that is affected
by this change.

Note: If Tier 1 status of entity personnel is affected by the removal of an agent, see Update to an
Individual’s Access to Tier 1 Agents/Toxins
Additional Information


An approved APHIS/CDC Form 2 is required prior to the transfer of select agents
and/or toxins to another registered entity.



APHIS/CDC Form 1 Instructions

127

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Removal of Select Agent/Toxin from a PI (but not the Entity)
To remove a select agent/toxin from a PI, submit the following documentation:

□
□

Request specifying the select agent/toxin to be removed.
Disposition of select agent/toxin


□

□
□

Verification of inventory audit
o

Destroyed – Provide documentation of destruction (e.g. autoclave records and
statement signed by witness).

Transferred – Provide documentation consistent with your intra-entity transfer
protocols (e.g., chain-of-custody) or APHIS/CDC Form 2 transfer number (ex.
CEA 123456) for transfer outside the entity.

If the entity is removing a select toxin from its registration, but will continue to possess the
select toxin under the regulated aggregate amount,


Statement and/or records showing that the amount of toxin possessed by the
registered PI is under the regulated aggregate amount.



Statement of how the entity will ensure that each PI’s select toxin inventory remains
below the regulated aggregate amount.

Complete Section 7A that removes the requested select agent/toxin for this PI.
Complete Section 7C that removes the requested select agent/toxin for this PI.

Note: If Tier 1 status of entity personnel is affected by the removal of an agent, see Update to an
Individual’s Access to Tier 1 Agents/Toxins
Additional Information


An approved APHIS/CDC Form 2 is required prior to the transfer of select agents
and/or toxins to another registered entity.



(1) Upon the physical relocation of a collection or inventory of select agents or
toxins for those select agents or toxins in the collection or inventory;
(2) Upon the departure or arrival of a principal investigator for those select agents
and toxins under the control of that principal investigator; or
(3) In the event of a theft or loss of a select agent or toxin, all select agents and
toxins under the control of that principal investigator.
For additional information on inventory audits, refer to the Security Guidance for
Select Agent or Toxin Facilities.

APHIS/CDC Form 1 Instructions

128

Version 1.6 January 18, 2017

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Federal Select Agent Program website
Destroy obsolete versions unless retained as a historical record.

Addition of New Work
The addition of new work may require an inspection prior to approval.
To add new work, submit the following documentation:

□
□

Request specifying the work to be added.
Complete Section 7C that includes all pending and approved work for each PI that is affected
by this change.


New Section 7 Attachments may be required based on the new work/change in
objectives of work.

□

Request for approval of any proposed restricted experiments (section 13 of the regulations) or
exclusions (section 3(d) and 3(e) of the regulations). Attachment B will capture information
about restricted experiments.

□
□
□

If adding a new suite/room, see Addition of a Suite/Room.
If adding a new PI, see Addition or Reactivation of a PI.
If adding a new select agent/toxin, see Addition of Select Agent/Toxin.
Additional Information







The addition of new work with a select agent or toxin requires that written plans,
as applicable, are commensurate with the risk of the agent or toxin given its
intended use. This includes ensuring that plans are updated and provisions and
procedures described are in effect as of the date that the amendment is
submitted, in accordance with the requirements of the Select Agent Regulations.
If a restricted experiment is included in Section 7C, Question 1 (objectives of
work) and/or Attachment B, you may receive a request for additional information
from the FSAP.
Certain objectives of work need specific FSAP approval. Consult with your
designated FSAP representative or contact the CDC at 404-718-2000 or APHIS
at 301-851-3300 option 3 for further information. For example:
o Reconstructed replication competent forms of the 1918 pandemic
influenza virus.
o Experiments that involve the deliberate transfer of, or selection for, a drug
or chemical resistance trait to select agents that are not known to acquire
the trait naturally, if such acquisition could compromise the control of
disease agents in humans, veterinary medicine, or agriculture, even if the
drug or chemical resistance is temporary. Note: Chemical resistance
applies to plant pathogens.
o Experiments involving the deliberate formation of synthetic or
recombinant DNA containing genes for the biosynthesis of select toxins
lethal for vertebrates at an LD[50] < 100 ng/kg body weight.
Work with a select agent or toxin at a biosafety level lower than that
recommended by the current edition of the BMBL or other nationally recognized
guidance requires special consideration.

APHIS/CDC Form 1 Instructions

129

Version 1.6 January 18, 2017

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Removal of Work
To remove work, submit the following documentation:

□
□

Request specifying all changes.
Complete Section 7C that removes the requested select agent/toxin work for each PI that is
affected by this change.


□
□
□

Removal of work may require updating Section 7 Attachments.

If removing a suite/room, see Removal of Suite/Room.
If removing a PI, see Removal of a PI.
If removing a select agent/toxin, see Removal of Select Agent/Toxin from the Entity.

If removal of work leads to storage only conditions, submit the following documentation:

□
□
□

Request specifying all changes.
Complete Section 7A that updates biosafety level(s) to storage.
Complete Section 7C that updates the work objective to storage only.
Note: Attachments A-G are not required for entities registering for storage only.

□
□
□

If removing a suite/room, see Removal of Suite/Room.
If removing a PI, see Removal of a PI.
If removing a select agent/toxin, see Removal of Select Agent/Toxin from the Entity.

APHIS/CDC Form 1 Instructions

130

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Federal Select Agent Program website
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Strain Update
Updated strain information should be 1) maintained on a real time basis, 2) submitted quarterly if
strain related changes in your entity’s inventory have occurred or 3) submitted annually if no strain
related changes have occurred in your entity’s inventory since the last submission.

□
□
□

Request specifying all changes.

□
□

If the entity is adding a select agent/toxin, see Addition of a Select Agent/Toxin.

Updated Section 7B for each PI that is affected by this change.
For additional information about designating strains or serotypes, see Strain or Serotype
Designations.

If the entity is removing a select agent/toxin, see Removal of a Select Agent/Toxin.

APHIS/CDC Form 1 Instructions

131

Version 1.6 January 18, 2017

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Federal Select Agent Program website
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Facility Amendments
Addition of a Suite/Room
The addition of a new suite/room may require an inspection prior to the approval of the amendment.
Each suite/room must be assigned a PI and at least one select agent/toxin on Section 7A.
To add a suite/room, submit the following documentation:

□
□

Request specifying suite/room to be added.

□
□

Complete Section 6 for the suite/room.

□

Complete Section 7A listing all agents and locations for each PI that is affected by this change
for the first submission only.

Complete Section 5 (as applicable) with any updated information regarding entity-wide
physical security, biosafety/biocontainment, and entry requirements for FSAP inspectors.

Floor plan as detailed in Section 6B and an expanded floor plan showing the suite/room
relative to the building layout.



A partial Section 7A will be submitted for subsequent amendment submission.



The biosafety level of the suite/room should be consistent with BMBL containment
recommendations for the select agent/toxin listed and work described.

□

Complete Section 7C if amendment involves the addition of a BSL-3Ag or BSL-4 suite/room or
if any change to Section 7C is required.

□
□

If suite/room will be operated at BSL4/ABSL4 safety level, Attachment G.

□
□

If adding a new PI, see Addition or Reactivation of a PI.

If work objectives for the PI(s) affected by this change will increase in scope, see Addition of
New Work.

If adding a new select agent/toxin, see Addition of Select Agent/Toxin.

To add storage designation to a registered laboratory, submit the following documentation:

□
□

Request specifying suite/room to be updated.
A partial Section 7A that lists only the requested suite/room and storage additions for each PI
that is affected by this change.
Additional Information


The addition of a new suite or room requires that written plans, as applicable, are
site-specific to include the additional location. This includes ensuring that plans
are updated and provisions and procedures described are in effect as of the date
that the amendment is submitted, in accordance with the requirements of the

APHIS/CDC Form 1 Instructions

132

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Additional Information
Select Agent Regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part
331).

APHIS/CDC Form 1 Instructions

133

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Federal Select Agent Program website
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Removal of Suite/Room
It is important for entities to consider how the removal of a suite/room may affect other aspects of their
registration (e.g., the room to be removed is the only registered location for a select agent/toxin or a
PI) and submit updates to other sections of APHIS/CDC Form1 as needed.
To remove a suite/room, submit the following documentation:

□
□

Request specifying the suite/room to be removed.

□

Complete Section 7A that removes the requested suite/room for each PI that is affected by this
change.

□

If removal of suite/room removes a select agent/toxin, see Removal of Select Agent/Toxin
from the Entity.

Documentation that effective decontamination appropriate to the use of the suite/room has
been performed. If you believe decontamination is not necessary, provide a risk assessment
and/or contact your designated FSAP representative.

Note: If a select agent/toxin is being transferred to a different PI at your entity (intra-entity
transfer) and this PI is not registered for the select agent/toxin, an updated Section 7 adding
this select agent/toxin will need to be submitted and approved before the receiving PI takes
possession of the select agent/toxin.

□
□
□

If removal of suite/room removes a PI, see Removal of a PI.
If removal of suite/room will also remove work, see Removal of Work.
If personnel are being removed, see Removal of Laboratorians, Animal Care Staff, Support
Staff, and Unescorted Visitors, Removal of RO, ARO, or Owner/Controller or Removal of a PI,
as appropriate.

APHIS/CDC Form 1 Instructions

134

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Update to Building and Suite/Room Specific Security
Entities should periodically review the information contained in this section and notify the FSAP of any
changes. Updates to Section 6A may be required. For example:






Addition of security lights or guards
Addition of biometric system
Addition of intrusion detection system
Addition of pass-through autoclave
Removal of locks

To update building and suite/room specific security, submit the following documentation:

□
□

Request stating the building and suite/room security information to be updated.
Complete Section 6A with updated information.

APHIS/CDC Form 1 Instructions

135

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Update to Suite/Room Physical Information
Entities should periodically review the information contained in this section and notify the FSAP of any
changes. Updates to Section 6B may be required. For example:



Addition or removal of a sink, eyewash or BSC
Changes to the HVAC system

To update suite/room physical information, submit the following documentation:

□
□

Request stating the suite/room physical information to be updated.
Complete Section 6B with updated information.

APHIS/CDC Form 1 Instructions

136

Version 1.6 January 18, 2017

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Other Amendments
Entity Name or Address Changes
A change of address, including a change of physical address, may be requested as an amendment
and must include a detailed explanation.
To change the entity name or address, submit the following documentation:

□
□

Request specifying changes.
Complete Section 1A.
Note: Section 1A denotes the physical location at which the entity is registered to possess
select agents and/or toxins. The physical address will display on the entity’s certificate of
registration and is normally not changed unless there are extenuating circumstances such as
roads which are renamed, addresses being changed by the post office, or a change in
physical location by the entity.
Note: The entity’s mailing address to which all official correspondence will be sent should be
provided in the address field under RO Information.

□
□

Complete Section 1B with signatures for the RO and all AROs.
Any change in the physical location of the entity will most likely require new Sections 5A, 5C, 6
and 7 as well as revision of entity-specific biosafety, security, and incident response plans, and
an inspection.
Additional Information


APHIS/CDC Form 1 Instructions

137

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Update to Entity Institutional Mission, Function and/or Size
Entities should periodically review the information contained in this section and notify the FSAP of any
substantive changes.
To update an entity abstract, submit the following documentation:

□
□

Request stating the entity abstract information to be updated.
Complete Section 1C with updated information.

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Update to Entity Wide Security and Incident Response
Updates to Section 5A may be required. For example:
 Recent break-in
 Threats or protests at the entity
 Changes to electronic access security
 Addition of a lock box for select agents/toxins
To update entity wide security and incident response, submit the following documentation:

□
□

Request stating the entity wide security information to be updated.
Complete Section 5A with updated information.

Additional Information


Changes to entity wide security and/or incident response require that written
plans, as applicable, are site-specific and in accordance with the entity’s risk
assessments. This includes ensuring that plans are updated and provisions and
procedures described are in effect as of the date that the amendment is
submitted, in accordance with the requirements of the Select Agent Regulations.

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Update to Entity-Wide Biosafety/Biocontainment
Updates to Section 5B may be required. For example:
 Significant changes to the entity’s biosafety program.
 Addition of Tier 1 select agents requiring individuals with access to be enrolled in an
occupational health program.
To update entity wide biosafety/biocontainment, submit the following documentation:

□
□

Request stating the biosafety/biocontainment information to be updated.
Complete Section 5B with updated information.

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Update to Entity Entry Requirements for Federal Select Agent Program Inspectors
Entities should periodically review the information contained in this section and notify the FSAP of any
changes. Updates to Section 5C may be required. For example:
 Addition of new work, suite/room, or select agent/toxin
 Update to vaccination requirement for entry into registered suite/room
To update entry requirements, submit the following documentation:

□
□

Request stating the entry requirements to be updated.
Complete Section 5C with updated information.
Note: This section should only be updated when an entity adds or removes work or makes a
policy change. It should not be updated to reflect changes in entry requirements based on
when work is active or inactive.

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Withdrawal Requests
Amendment Withdrawal
To withdraw an amendment, submit the following documentation:

□

Request stating wish to withdraw the amendment. Include the amendment number and the
changes originally requested.
Note: An amendment adding an individual cannot be withdrawn. Instead, submit an update to
the amendment adding the individual that requests removal of the individual.

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Registration Withdrawal
To withdraw from the Federal Select Agent Program, submit the following documentation:

□

Request stating wish to withdraw registration, the reason for withdrawal, and the disposition of
agents/toxins.

□

Disposition of select agent(s) and/or toxin(s).



Destroyed – Provide documentation of destruction (e.g., autoclave records and
statement signed by witness).
Transferred – Provide the APHIS/CDC Form 2 transfer number from when select
agents/toxins were transferred to a different registered entity (ex. CEA123456).

□

Documentation that effective decontamination appropriate to the use of the suite(s)/room(s)
must be provided. If you believe decontamination is not necessary, provide a risk assessment
and/or contact your designated FSAP representative.

□

If the entity was registered for and possessed select toxin(s) and will now operate with select
toxin(s) below the regulated aggregate amount,



Statement and/or records showing that the amount of toxin(s) possessed by the
registered PI(s) is under the regulated aggregate amount.
Statement of how the entity will ensure that each PI’s select toxin inventory remains
below the regulated aggregate amount.
Additional Information



An approved APHIS/CDC Form 2 is required prior to the transfer of select agents
and/or toxins to another registered entity.

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Definitions
Access – An individual will be deemed to have access at any point in time if the individual has
possession of a select agent or toxin (e.g., ability to carry, use, or manipulate) or the ability to gain
possession of a select agent or toxin.
Alternate Responsible Official (ARO) – The individual(s) designated by an entity that acts for the
Responsible Official.
Animal and Plant Health Inspection Service (APHIS) – A multi-faceted Agency with a broad
mission area that includes protecting and promoting U.S. agricultural health, regulating genetically
engineered organisms, administering the Animal Welfare Act and carrying out wildlife damage
management activities. These efforts support the overall mission of USDA, which is to protect and
promote food, agriculture, natural resources and related issues.
Biosafety Cabinet (BSC) – The primary means of containment developed for working safely with
infectious microorganisms that are designed to provide personnel, environmental and product
protection when appropriate practices and procedures are followed.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) – The Centers for Disease
Control and Prevention and the National Institutes of Health publication serves as a nationally and
internationally recognized source for the standards and special microbiological practices, safety
equipment, and facilities to work with a variety of infectious agents in various laboratory settings. The
BMBL utilizes 4 biosafety levels (BSL 1 through 4) for work with pathogenic microorganisms based
upon a risk assessment.
Biosafety Level (BSL) – The primary risk criteria used to define the four ascending levels of
containment, referred to as biosafety levels 1 through 4, are infectivity, severity of disease,
transmissibility, and the nature of the work being conducted. Another important risk factor for agents
that cause moderate to severe disease is the origin of the agent, whether indigenous or exotic. Each
level of containment describes the microbiological practices, safety equipment and facility safeguards
for the corresponding level of risk associated with handling a particular agent. The basic practices and
equipment are appropriate for protocols common to most research and clinical laboratories. The
facility safeguards help protect non-laboratory occupants of the building and the public health and
environment.
Bioterrorism Security Risk Assessment Form (FD-961 Form) – The FBI’s Application for Security
Risk Assessment that assists the Federal Bureau of Investigation (FBI), Criminal Justice Information
Services Division (CJIS) to perform an electronic records check to determine if an individual who has
been identified by a registered entity as having a legitimate need to access select agents or toxins
exhibits one of the statutory restrictors which would either prohibit or restrict access.
Centers for Disease Control and Prevention (CDC) – One of the major operating components of
the Department of Health and Human Services and its mission is to collaborate to create the
expertise, information, and tools that people and communities need to protect their health – through
health promotion, prevention of disease, injury and disability, and preparedness for new health
threats.
Chemical Hygiene Plan (CHP) – Written program stating the policies, procedures and
responsibilities that protect workers from the health hazards associated with the hazardous chemicals
used in that particular workplace.
Criminal Justice Information Services (CJIS) – The Division of the Federal Bureau of Investigation
that conducts security risk assessments of all individuals, Responsible Officials, Alternate
Responsible Officials and non-governmental entities that request access to select agents and toxins.
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Containment – Safe methods, facilities and equipment for managing infectious materials in the
laboratory environment where they are being handled or maintained.
Department of Justice (DOJ) Number or Unique Identifying Number (UIN) – number provided to
the Responsible Official by the FSAP for each individual listed on the APHIS/CDC Form 1. Each
individual that completes the FD-961 Form must include the DOJ/UIN in Section II, item #11 of the
form.
Effluents – Effluents are liquids such as those originating from laboratory sinks, floor drains, and
other sources that are discharged into a sewer system. Where required*, these effluents are collected
and decontaminated before disposal. A heat decontamination system holds contaminated liquid
effluents to temperatures, pressures and times sufficient to inactivate biohazardous materials. A
chemical decontamination system treats contaminated liquid effluents with an appropriate chemical
disinfectant for a prescribed period of time to inactivate biohazardous materials.
* Effluent decontamination is required for maximum containment facilities performing work at BSL4,
ABSL4, and BSL3Ag.For propagative work performed at BSL3with highly transmissible and
pathogenic agents, such as highly pathogenic Avian influenza virus, Classical swine fever virus, and
African Swine fever virus, liquid effluents must be decontaminated prior to release into a sewer
system.
Entity – Any government agency (Federal, State, or local), academic institution, corporation,
company, partnership, society, association, firm, sole proprietorship, or other legal entity. See also
“Facility”.
Facility – As used in this document, a “facility” is the physical structure where select agents or toxins
are used, manipulated, and/or stored. An entity can be composed of multiple facilities, and a facility
may contain multiple suites/rooms where work is performed and/or select agents or toxins are stored.
Federal Select Agent Program (FSAP) – The joint management of Centers for Disease Control and
Prevention’s Division of Select Agents and Toxins and the Animal and Plant Health Inspection
Service’s Agricultural Select Agent Program of the Select Agent Regulations.
High Efficiency Particulate Air (HEPA) filter – An air filter composed of a mat of dense fibers
arranged in folds, designed according to federal standards to trap at least 99.97% of airborne particles
measuring 0.3 microns in diameter. HEPA filters remove bacteria, spores and viruses from the air with
an efficiency of 99.97% or greater. HEPA filters and HEPA filter housings must be inspected annually.
Institutional Animal Care and Use Committee (IACUC) – A self-regulating entity that, according to
U.S. federal law, must be established by institutions that use laboratory animals for research or
instructional purposes to oversee and evaluate all aspects of the institution's animal care and use
program.
Institutional Biosafety Committee (IBC) – An institutional committee created under the NIH
Guidelines to review research involving recombinant DNA. The role of IBCs has evolved over time,
and many committees also review other forms of research that entail biohazardous risks as part of
their institutionally assigned responsibilities.
In vitro – In glass, as in a test tube. An in vitro test is one done in the laboratory, usually involving
isolated tissue, organ, or cell preparations.
In vivo – In the living body or organism. An in vivo test is one performed on a living organism.
Laboratorians and Animal Care Staff – Individuals who perform any of the work listed in a Section
7C, Question 1 and/or handle or manipulate select agents or toxins or handle select agent infected
animals, plant hosts or select agent contaminated hazardous waste (including animal bedding).
N95 respirator – A particulate filtering face piece respirator that filters at least 95% of airborne
particles 0.3 microns and larger, but is not resistant to oil, and will not filter out volatile chemicals or
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other substances for which it is not designed to serve as a protective device. A N95 can be used to
provide respiratory protection when working with biological agents. See also “N100”.
N100 respirator – A particulate filtering face piece respirator that filters at least 99.97% of airborne
particles 0.3 microns and larger, but is not resistant to oil, and will not filter out volatile chemicals or
other substances for which it is not designed to serve as a protective device. A N100 can be used to
provide respiratory protection when working with biological agents.
NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) – A
document that provides risk assessment, physical containment, and biological containment provisions
relating to genetic elements, recombinant nucleic acids and recombinant organisms of select agents
and toxins.
Occupational Health – Occupational health is a cross-disciplinary area concerned with protecting the
safety, health and welfare of people engaged in work or employment. The goals of occupational
health programs include fostering a safe and healthy work environment. They also seek to protect coworkers, family members, employers, customers, and many others who might be affected by the
workplace environment. Occupational health may involve interactions among many subject areas,
including occupational medicine, occupational hygiene, public health, safety engineering, industrial
engineering, chemistry, health physics, ergonomics and occupational health psychology.
Occupational Safety and Health Administration (OSHA) regulations – 29 CFR Parts 1910.1200
and 1910.1450 provides specific requirements for handling toxins.
Owner/Controller – An individual is considered an Owner/Controller if the individual owns 50 percent
or more of the entity, and/or is a holder or owner of 50 percent or more of the entity’s voting stock,
and/or is an individual who is in a managerial or executive capacity with regard to the entity's select
agents or toxins or with regard to the individuals with access to the select agents or toxins possessed,
used, or transferred by the entity.
Powered Air Purifying Respirators (PAPR) – PAPRs use a motorized air source to filter and clean
ambient air before it is delivered to the user, usually through a full head covering (hood). PAPR
systems can use many different filters such as HEPA, vapor protection, activated charcoal, or simple
particulate filtration. A PAPR with HEPA filtration can be used to provide respiratory protection when
working with biological agents.
Principal Investigator (PI) – The individual who is designated by the entity to direct a project or
program and who is responsible to the entity for the scientific and technical direction of that project or
program.
Personal Protective Equipment (PPE) – Any protective clothing, such as gloves, coats, gowns,
shoe covers, boots, respirators, face shields, safety glasses, or goggles, or other garment or
equipment designed to protect the wearer's body from injury by blunt or sharp impacts, electrical
hazards, heat, chemicals, and infection, for job-related occupational safety and health purposes. PPE
is used to reduce employee exposure to hazards when engineering and administrative controls are
not feasible or effective to reduce these risks to acceptable levels. In these cases, PPE is often used
in combination with BSCs and other devices that contain the agents, animals, or materials being
handled to reduce risk of exposure or escape. In some situations in which it is impractical to work in
BSCs, personal protective equipment may form the primary barrier between personnel and the
infectious materials. Examples include certain animal studies, animal necropsy, agent production
activities, and activities relating to maintenance, service, or support of the laboratory facility.
Purified Protein Derivative (PPD) test – A diagnostic tool used to determine exposure to
tuberculosis bacilli. The PPD test consists of an intradermal injection of PPD tuberculin, and the size
of induration is measured 48–72 hours later. This test is generally required as part of an occupational
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health program as an initial and ongoing assessment for personnel who work with animals. Also
known as the Mantoux screening test, tuberculin sensitivity test, or Pirquet test.
Responsible Official (RO) – The individual designated by an entity with the authority and control to
ensure compliance with the Select Agent Regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR
Part 331).
Room – As used in this document, a “room” is the physical location where select agents or toxins are
used, manipulated, or stored. A facility may contain multiple rooms where work is performed and/or
select agents/toxins are stored. Also see “Suite”.
Security Risk Assessment (SRA) – Electronic records check performed by CJIS to determine if an
individual who has been identified by a registered entity as having a legitimate need to access select
agents or toxins exhibits one of the statutory restrictors which would either prohibit or restrict access.
Select Agent and Toxin – The biological agents and toxins listed in 42 CFR Part 73, 9 CFR Part 121,
and 7 CFR Part 331 that have the potential to pose a severe threat to public health and safety, to
animal health or products, or to plant health or products.
Suite – As used in this document, a “suite” is a collection of rooms with the same biosafety level (2, 3,
or 4) that share a containment envelope or that are grouped together. A facility may have multiple
suites where work is performed and/or select agents/toxins are stored. Also see “Room”.
Support Staff – An individual who provides an indirect service in support of the direct work with select
agents or toxins, but does not work with select agents or toxins or select agent infected animals,
bedding or plant hosts. These personnel are SRA approved and registered with the FSAP because
they could potentially gain access to select agents/toxins.
To be Acquired (TBA) – TBA is used in Section 7B for each select agent, toxin or regulated nucleic
acid for which the entity is registered but does not currently possess. Also see “TBD”.
To be Determined (TBD) – TBD is used in Section 7B if there are defined strains of the agent but the
entity does not have strain information for that agent (e.g., diagnostic samples that were not identified
to the strain level). Also see “TBA”.
Tier 1 Select Agents and Toxins – A subset of select agents and toxins designated in the Select
Agent Regulations as “Tier 1” because these agents and toxins present the greatest risk of deliberate
misuse with the most significant potential for mass casualties or deleterious effects on the economy,
critical infrastructure, or public confidence. This list can be found in the instructions for Section 3 in
this document and at SelectAgents.gov.

Change History
Version
1.0

Date
06/24/2013

1.1

12/9/13

1.2

9/8/2014

APHIS/CDC Form 1 Instructions

Summary of Changes
Initial release. These instructions replace the existing Form 1
Guidance Document.
Second release. Updated section 1A; Section 6A, Q4; Section 6B,
Q1; Section 6B, Q16; Section 7C, Q9; Attachment A, Q3; and
Amendment Reference table in New Application section. In
Amendment section, updated Addition of a Select Agent/Toxin,
Addition of a Tier 1 Select Agent/Toxin, and Addition of a
Suite/Room
Third release. Updated APHIS phone number; clarified initial,
update, and renewal for type of submittal; updated appropriate
sections to include the policy for work with registered toxin below
the permissible amount; updated language regarding chimeric
viruses; adding link to training requirements; updated Sections 3,
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Version

Date

1.3

6/4/15

1.4

12/17/15

1.5

5/20/2016

1.6

1/18/17

APHIS/CDC Form 1 Instructions

Summary of Changes
5A, 6B, 7A to require complete 7A for first submittal on newly
revised form, 7B, 7C, Attachments A, B, and C. In Amendment
section, updated use of electronic signatures; requirements for
submission of the following amendment types: Addition of a
Select Agent, Addition of a Tier 1 Select Agent, Addition of a
suite/room, Addition of New Work; included instructions for
moving from work to storage only conditions; updated
requirements for the addition of a BSL-3Ag or BSL-4 suite/room,
added definition for effluent.
Fourth release. Updated sections 1, 3, 4, 5, 6, 7 and Attachments
B & C. Amendment section regarding addition of SARS, removal
of agent and addition of work.
Fifth release. Clarify when section 4 and 7C is needed, provide
additional guidance for validation of effluent decontamination
systems, added use of electronic signatures.
Sixth release. Update instructions for Section 2; clarify when
email request for amendment change is allowed; update
requirements for entity withdrawal; add note to Amendment
section regarding addition of a Tier 1 SAT; updated floor plan
instructions in Section 6B.
Seventh release. Added statement that pdf or excel version of
Sections 4A, 4B, 4C, and 7B can be used; clarified note about
effluent decontamination requirements in Section 6B and
definitions. Added new agent Bacillus cereus Biovar anthracis.
Updated toxin permissible amounts.

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File Type	application/pdf
File Title	Guidance Document for the Completion of APHIS/CDC Form 1
Subject	Select Agents and Toxins
Author	Federal Select Agent Program
File Modified	2017-01-19
File Created	2017-01-19