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

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

Att1-Application for Registration - Form1

Application for Registration (APHIS/CDC Form 1)

OMB: 0920-0576

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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 3.75 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.


Table of Contents


Section 1A – Entity Information 3

Section 1B – Certification of Responsibility 4

Section 1C – Entity Abstract 5

Section 2 – Responsible Official Certification of Personnel and Facility Activities 6

Section 2 – Responsible Official Certification of Personnel and Facility Activities (Continued) 7

Section 3 – Select Agents and Toxins 8

Section 4A – Laboratorians and Animal Care Staff 9

Section 4B – Support Staff 10

Section 4C – Unescorted Visitors 11

Section 5A – Entity-Wide Security Assessment and Incident Response 12

Section 5B – Entity-Wide Biosafety/Biocontainment 14

Section 5C – Entry Requirements for Federal Select Agent Program Inspectors 15

Section 6A – Building and Suite/Room Specific Security 16

Section 6A – Building and Suite/Room Specific Security (Continued) 17

Section 6B – Room/Suite Physical Information 18

Section 6B – Room/Suite Physical Information (Continued) 19

Section 7A – Principal Investigator (PI) Information and Select Agent and Toxin Locations 20

Section 7B – Strain or Serotype Designation Information 21

Section 7C – Description of Work 22

Attachment A –Work with Toxins 24

Attachment A –Work with Toxins (Continued) 25

Attachment B – Work with Regulated Nucleic Acids, Genetic Modification of Select Agents or Toxins, Recombinant/Synthetic Nucleic Acids, or Recombinant Synthetic Organisms 26

Attachment B – Work with Regulated Nucleic Acids, Genetic Modification of Select Agents and Toxins, Recombinant/Synthetic Nucleic Acids, or Recombinant Synthetic Organisms (Continued) 27

Attachment C – Work with Animals 28

Attachment C – Work with Animals (Continued) 29

Attachment D – Work with Plants 30

Attachment D – Work with Plants (Continued) 31

Attachment E – Work with Arthropods 32

Attachment E – Work with Arthropods (Continued) 33

Attachment F – BSL3Ag Laboratories 34

Attachment F – BSL3Ag Laboratories (Continued) 35

Attachment G – BSL4/ABSL4 Laboratories 36

Attachment G – BSL4/ABSL4 Laboratories (Continued) 37






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 XX/XX/XXXX


Section 1A – Entity Information


This submission is:

A new registration

An update to an existing registration

A renewal

Date:


ENTITY INFORMATION


Entity Application Number (e.g., CDC030001):


Current Registration Number (e.g., A00000000-0000):


Entity Name:


Physical Address (NOT a post office box):

City:

State:

Zip Code:


Additional Physical Address(es):


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

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


RESPONSIBLE OFFICIAL INFORMATION


Last Name:

First Name:

DOJ Number:

Date of
Birth:


Business E-mail Address:

Title (e.g., Biosafety Officer):

Shape1 Tier 1 Access


Business Telephone #:

Business Fax #:

Emergency Telephone #:


Mailing Address (NOT a post office box):

City:

State:

Zip Code:


ALTERNATE RESPONSIBLE OFFICIAL INFORMATION


Last Name:

First Name:

DOJ Number:

Date of
Birth:


Business E-mail Address:

Title (e.g., Biosafety Officer):

Shape2 Tier 1 Access


Business Telephone #:

Business Fax #:

Emergency Telephone #:


Mailing Address (NOT a post office box):

City:

State:

Zip Code:


Last Name:

First Name:

DOJ Number:

Date of
Birth:


Business E-mail Address:

Title (e.g., Biosafety Officer):

Shape3 Tier 1 Access


Business Telephone #:

Business Fax #:

Emergency Telephone #:


Mailing Address (NOT a post office box):

City:

State:

Zip Code:


OWNER / CONTROLLER INFORMATION (If Applicable)


Last Name:

First Name:


DOJ Number:

Date of Birth:

Shape4 Tier 1 Access


Last Name:

First Name:


DOJ Number:

Date of Birth:

Shape5 Tier 1 Access


This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:


Section 1B – Certification of Responsibility


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


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







Responsible Official Signature


Date


Responsible Official Name







Alternate Responsible Official Signature


Date


Alternate Responsible Official Name







Alternate Responsible Official Signature


Date


Alternate Responsible Official Name







Alternate Responsible Official Signature


Date


Alternate Responsible Official Name







Alternate Responsible Official Signature


Date


Alternate Responsible Official Name














This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:


Section 1C – Entity Abstract


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








This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:


Section 2 – Responsible Official Certification of Personnel and Facility Activities

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

Security, Biosafety and Incident Response


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


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


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


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


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


Training


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


Records


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


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


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


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


Responsible Official Duties & APHIS/CDC Program Notification

The Responsible Official will:


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



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



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



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


This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:


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

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


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

The Responsible Official will:


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



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


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












Responsible Official Signature


Date


Responsible Official Name (Typed or Printed)




This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:


Section 3 – Select Agents and Toxins



HHS Agents and Toxins

(Check if possessed)

Overlap Agents and Toxins

(Check if possessed)

USDA Agents and Toxins

(Check if possessed)


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This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:


Section 4A – Laboratorians and Animal Care Staff

Tier 1 Access

Last Name


First Name



DOJ Unique Identifier Number

Date of Birth

(mm/dd/yyyy)


Role

Supervising Principal Investigator

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


RO/ARO Signature:_________________________________________________ Date: _______________




This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:



Section 4B – Support Staff

Tier 1 Access

Last Name


First Name



DOJ Unique Identifier Number

Date of Birth

(mm/dd/yyyy)

Role

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


RO/ARO Signature:_________________________________________________ Date: _______________


This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:


Section 4C – Unescorted Visitors

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

Tier 1 Access

Last Name


First Name



HOME ENTITY DOJ Unique Identifier Number

Date of Birth

(mm/dd/yyyy)


Supervising Principal Investigator


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


RO/ARO Signature:_________________________________________________ Date: _______________


This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:


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



1.

The facility is: (check all that apply)





Shape96

Government owned

Shape97

Rented/leased



Shape98

Entity owned

Shape99

Shared with another entity or



Shape100

Other ______________________


program







2.

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

Shape101 Yes

Shape102 No



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

Shape103 Yes

Shape104 No






3.

A threat assessment has been conducted:

Shape105 Yes

Shape106 No


a.

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

Shape107 Yes

Shape108 No


b.

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

Shape109 Yes

Shape110 No


c.

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

Shape111 Yes

Shape112 No


d.

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

Shape113 Yes

Shape114 No



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












4.

Insider risk assessment




a.

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





Shape115

Educational background





Shape116

Previous work references





Shape117

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



Shape118

Other ____________________________





Shape119

None




b.

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

Shape120 Yes

Shape121 No


c.

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

Shape122 Yes

Shape123 No







5.

Natural hazards




a.

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





Shape124

Flood/flood zone

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Earthquake (as defined by USGS)



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Hurricane

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Wildfire



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Tornado

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Tsunami



Shape130

Other__________________________




b.

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





Shape131

Secure the select agent and/or toxin in place.





Shape132

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



Shape133

Destroy the select agent and/or toxin.





Shape134

Other ____________________________


This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:


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


6.

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

Shape135 Yes

Shape136 No



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




a.

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

Shape137 Yes

Shape138 No


b.

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

Shape139 Yes

Shape140 No


c.

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

Shape141 Yes

Shape142 No


d.

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

Shape143 Yes

Shape144 No


e.

Are user-based passwords employed?

Shape145 Yes

Shape146 No


f.

Are anti-virus and anti-malware programs employed?

Shape147 Yes

Shape148 No






7.

Shipping/Receiving




a.

Does the entity have a centralized receiving area?

Shape149 Yes

Shape150 No


b.

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

Shape151 Yes

Shape152 No


c.

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

Shape153 Yes

Shape154 No





8.

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

Shape155 Yes

Shape156 No



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





a.

through non-registered areas?

Shape157 Yes

Shape158 No



b.

during intra-entity transfers using chain of custody documentation?

Shape159 Yes

Shape160 No





9.

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

Shape161 Yes

Shape162 No





10.

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

Shape163 Yes

Shape164 No



If yes, who grants permission?





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RO/ARO



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PI



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Other _________________________







This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:


Section 5B – Entity-Wide Biosafety/Biocontainment


1.

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








2.

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

Shape168 Yes

Shape169 No





3.

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

Shape170 Yes

Shape171 No





4.

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

Shape172 Yes

Shape173 No






5.

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

Shape174 Yes

Shape175 No





6.

There are policies for the safe handling of sharps.

Shape176 Yes

Shape177 No





7.

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

Shape178 Yes

Shape179 No





8.

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

Shape180 Yes

Shape181 No



This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:


Section 5C – Entry Requirements for Federal Select Agent Program Inspectors


1.

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















2.

Identification requirements:






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Government ID






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Other ID (describe) ____________________







3.

Are there security clearance requirements?

Shape184 Yes

Shape185 No




If yes, check all that apply.





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Exchange of security clearance documentation







Describe ____________________________________________



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Completion of entity specific security documentation





Describe ____________________________________________







4.

Is respiratory protection required?

Shape188 Yes

Shape189 No



a.

Documentation of medical clearance for respirator use required.

Shape190 Yes

Shape191 No



b.

List required respirators (check all that apply):






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N95






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N100






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PAPR: If required, will the entity provide PAPRs?

Shape195 Yes

Shape196 No




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Other ___________________









5.

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















6.

Medical documentation required:

Shape198 Yes

Shape199 No



a.

Immunizations

Shape200 Yes

Shape201 No




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Required (specify) ________________________________________________




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Recommended (specify) ___________________________________________



b.

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

Shape204 Yes

Shape205 No




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In past 6 months?






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In the past 12 months?











7.

Is entity specific training required?

Shape208 Yes

Shape209 No




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















8.

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








This submission is:

A new registration

An update to an existing registration

A renewal


Entity Name:

Date:


Building/Suite or Room:



Section 6A – Building and Suite/Room Specific Security


1.

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

Shape210 Yes

Shape211 No





2.

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





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Security lighting



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Bars/security film on windows



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Exterior intrusion detection system



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Perimeter fence



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Roving guards



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Video surveillance of all access points



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Vehicle screening



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Other ________________________



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None





3.

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





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Lock and key

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Card access system



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Biometric system

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Card access system w/ PIN



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Other _____________________________

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Guards



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None







4.

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




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Additional locked doors




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Card access system




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Card access system with PIN




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Biometric System




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Intrusion detection system





a.

What triggers the alarm? ___________________________________





b.

Is the alarm contracted to an outside company?

Shape233 Yes

Shape234 No



c.

Who does the alarm notify? _________________________________





d.

Are any emergency exits equipped with the same kind of intrusion detection system as the customary entrances?

Shape235 Yes

Shape236 No


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Video surveillance





a.

Does the video surveillance observe select agent and/or toxin work?

Shape238 Yes

Shape239 No



b.

Does the video surveillance observe select agent and/or toxin storage?

Shape240 Yes

Shape241 No



c.

Does the video surveillance observe access to the registered room?

Shape242 Yes

Shape243 No



d.

Is the video monitored by security personnel?

Shape244 Yes

Shape245 No



e.

Is the video reviewed by laboratory personnel?

Shape246 Yes

Shape247 No


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Other _____________________________




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None






This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

Building/Suite or Room:



Section 6A – Building and Suite/Room Specific Security (Continued)


5.

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






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Lock and key




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Card access system




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Card access system with PIN




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Biometric System




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Other _____________________________________________________________








6.

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






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No access control on the storage unit(s)




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Lock and key




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Card access system




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Card access system with PIN




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Biometric System




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Other _____________________________________________________________









7.

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

Shape261 Yes

Shape262 No




If yes, are the doors interlocked?

Shape263 Yes

Shape264 No







8.

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

Shape265 Yes

Shape266 No




If yes, distance from suite/room to autoclave ___________________








9.

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

Shape267 Yes

Shape268 No




If yes, is it secured?

Shape269 Yes

Shape270 No








10.

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

Shape271 Yes

Shape272 No




If yes, is it secured?

Shape273 Yes

Shape274 No





This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

Building/Suite or Room:



Section 6B – Room/Suite Physical Information

For each registered storage area, laboratory suite or room:

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


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


Answer the following questions for each laboratory suite or room:


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


1.

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





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BSL2

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NIHBL2

Shape277

NIHBL2-LS



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ACL3



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BSL3

Shape280

NIHBL3

Shape281

NIHBL3-LS



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ACL4



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BSL4

Shape284

NIHBL4

Shape285

NIHBL4-LS







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ABSL2

Shape287

NIHBL2N









Shape288

ABSL3

Shape289

NIHBL3N









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BSL3Ag

Shape291

NIHBL4N









Shape292

ABSL4












List the resources/references used ­­­­­­­­­­­­­­­­­­­­______________________________________________________





2.

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

Shape293 Yes

Shape294 No





3.

A sink is present in the laboratory for hand washing.

Shape295 Yes

Shape296 No



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

Shape297 Yes

Shape298 No





4.

An eyewash station is readily available.

Shape299 Yes

Shape300 No





5.

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

Shape301 Yes

Shape302 No


If yes,




a.

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

Shape303 Yes

Shape304 No


b.

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

Shape305 Yes

Shape306 No





If BSL3Ag, BSL4 or ABSL4 is selected, proceed to Section 7.





6.

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

Shape307 Yes

Shape308 No



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

Shape309 Yes

Shape310 No


This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

Building/Suite or Room:



Section 6B – Room/Suite Physical Information (Continued)


7.

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

Shape311 Yes

Shape312 No





8.

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

Shape313 Yes

Shape314 No





9.

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

Shape315 Yes

Shape316 No





10.

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

Shape317 Yes

Shape318 No





11.

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

Shape319 Yes

Shape320 No





12.

Exhaust air is HEPA filtered.

Shape321 Yes

Shape322 No


a.

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

Shape323 Yes

Shape324 No



i.

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



ii.

HEPA filters and housings are certified at least annually.

Shape325 Yes

Shape326 No


b.

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

Shape327 Yes

Shape328 No





13.

Emergency shower is readily available.

Shape329 Yes

Shape330 No





14.

Floor drains are present.

Shape331 Yes

Shape332 No





15.

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

Shape333 Yes

Shape334 No





16.

Mechanical cage washer is present.

Shape335 Yes

Shape336 No



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

Shape337 Yes

Shape338 No





17.

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

Shape339 Yes

Shape340 No



This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:


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

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


PI

Last Name:

First Name:

DOJ Number:

Date of Birth:

Shape341 Tier 1 Access


Select Agent/Toxin/Regulated Nucleic Acid


Location

Laboratory or Storage

(Select one or both)


Laboratory Safety Level

(Leave blank if storage only)


Bldg

Suite/Room

Lab

Storage




Shape342

Shape343





Shape344

Shape345





Shape346

Shape347





Shape348

Shape349





Shape350

Shape351





Shape352

Shape353





Shape354

Shape355





Shape356

Shape357





Shape358

Shape359





Shape360

Shape361





Shape362

Shape363





Shape364

Shape365





Shape366

Shape367



Suite Legend:

(If Applicable)

Suite A = Rooms 1, 2, 3, 4


This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):



Section 7B – Strain or Serotype Designation Information


Select Agent/Toxin/ Regulated Nucleic Acid

Strain or Serotype Designations

Agent







Toxin







Regulated Nucleic Acid























































This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):



Section 7C – Description of Work


1.

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


Agent/Toxin

BSL

Objective of Work










.

2.

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



Agent

Maximum Quantity/Concentration










3.

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



Toxin

Maximum Quantity













4.

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

Shape368 Yes

Shape369 No




5.

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












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





6.

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

Shape370 Yes

Shape371 No



This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):



Section 7C – Description of Work (Continued)


7.

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

Shape372 Yes

Shape373 No


If yes, describe method:




Shape374

Autoclaved


Shape375

Chemical (disinfectant, concentration, and time) ___________________________________________


Shape376

Incineration


Shape377

Irradiation


Shape378

Other ______________________________________________________________________________



8.

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




Shape379

Lock and key


Shape380

Locked filing cabinet, drawer, cabinet, etc.


Shape381

Card access system


Shape382

Other _______________________________________________________________










9.

Will work be performed with:









a.

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

Shape383 Yes

Shape384 No



If yes, complete Attachment A – Work With Toxins










b.

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

Shape385 Yes

Shape386 No



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









c.

animals?

Shape387 Yes

Shape388 No



If yes, complete Attachment C – Work with Animals









d.

plants?

Shape389 Yes

Shape390 No



If yes, complete Attachment D – Work with Plants









e.

arthropods?

Shape391 Yes

Shape392 No



If yes, complete Attachment E – Work with Arthropods








10.

Will work be performed in:









a.

BSL3Ag laboratory?

Shape393 Yes

Shape394 No



If yes, complete Attachment F – BSL3Ag Laboratories









b.

BSL4/ABSL4 laboratory?

Shape395 Yes

Shape396 No



If yes, complete Attachment G – BSL4/ABSL4 Laboratories






This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):


Laboratory Safety Level:


Attachment A –Work with Toxins

1.

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

Shape397 Yes

Shape398 No





2.

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


Shape399

Dry forms


Shape400

Liquid forms


Shape401

Centrifugation


Shape402

Pressure filtration systems (e.g., chromatography)




3.

Animals are exposed to select toxins.

Shape403 Yes

Shape404 No


a.

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

Shape405 Yes

Shape406 No


b.

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







4.

Select toxin is produced by PI(s).

Shape407 Yes

Shape408 No



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








5.

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

Shape409 Yes

Shape410 No





6.

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

Shape411 Yes

Shape412 No



If yes, describe method:





Shape413

Autoclaved



Shape414

Chemical (disinfectant, concentration, and time) __________________________________



Shape415

Incineration



Shape416

Other ___________________________________________________________________





7.

Dilution procedures and other manipulations of concentrated select toxins are performed.

Shape417 Yes

Shape418 No



If yes, conducted in:





Shape419

Fume hood



Shape420

Biological Safety Cabinet (BSC)



Shape421

Outside of a BSC or fume hood



Shape422

Work is conducted with two knowledgeable people present.







8.

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

Shape423 Yes

Shape424 No


If yes, indicate below:




Shape425

Above the aggregate amount




Shape426

Below the aggregate amount







9.

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

Shape427 Yes

Shape428 No


This submission is:

A new registration

An update to an existing registration

A Renewal

Entity Name:

Date:

PI(s):


Laboratory Safety Level:


Attachment A –Work with Toxins (Continued)

10.

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

Shape429 Yes

Shape430 No



If yes, is there a hazard communication plan?

Shape431 Yes

Shape432 No







11.

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

Shape433 Yes

Shape434 No



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





This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):


Laboratory Safety Level:


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


1.

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




a.

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

Shape435 Yes

Shape436 No


b.

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

Shape437 Yes

Shape438 No


c.

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

Shape439 Yes

Shape440 No






2.

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




a.

Introduction and/or modification of genetic elements.

Shape441 Yes

Shape442 No


b.

Recombinant or synthetic nucleic acids.

Shape443 Yes

Shape444 No


c.

Recombinant or synthetic organisms.

Shape445 Yes

Shape446 No


d.

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

Shape447 Yes

Shape448 No






3.

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

Shape449 Yes

Shape450 No


a.

If yes, please indicate the type of restricted experiment:





Shape451

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




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






Select Agent ______________________

Drug Resistance Trait ______________




Select Agent ______________________

Drug Resistance Trait ______________




Select Agent ______________________

Drug Resistance Trait ______________



Shape452

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


b.

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

Shape453 Yes

Shape454 No





4.

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

Shape455 Yes

Shape456 No


a.

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





Shape457

Drug resistance trait(s) in select agent organisms.






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



Shape458

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






List toxin(s) ____________________________________________________


b.

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

Shape459 Yes

Shape460 No






5.

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

Shape461 Yes

Shape462 No



This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):


Laboratory Safety Level:


Attachment B – Work with Regulated Nucleic Acids, Genetic Modification of Select Agents and Toxins, Recombinant/Synthetic Nucleic Acids, or Recombinant Synthetic Organisms (Continued)


6.

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










7.

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

Shape463 Yes

Shape464 No



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

Shape465 Yes

Shape466 No



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










This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):


Laboratory Safety Level:


Attachment C – Work with Animals


1.

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




Select Agent / Toxin

Species of Animal

Route(s) of Administration












2.

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

Shape467 Yes

Shape468 No



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

Shape469 Yes

Shape470 No



3.

Describe the waste stream:


a.

Are animal carcasses, cages, and waste (e.g., sewage, bedding) treated prior to disposal by an approved method? (check all that apply):

Shape471 Yes

Shape472 No



Shape473

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







Shape474

Chemical (disinfectant, concentration, and time) _______________________________________



Shape475

Incineration



Shape476

Tissue Digester



Shape477

Other ________________________________________________________________________


b.

Waste Handling Procedures



Shape478

Waste decontaminated inside the containment area (e.g., pass-through autoclave loaded within the animal facility).



Shape479

Waste outside of the containment area for decontamination. Describe when and how waste is treated before transport out of the containment area. Add additional sheets as needed.









4.

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. Add additional sheets as needed.











5.

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

Shape480 Yes

Shape481 No



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

Shape482 Yes

Shape483 No







This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):


Laboratory Safety Level:


Attachment C – Work with Animals (Continued)


6.

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

Shape484 Yes

Shape485 No




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







7.

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

Shape486 Yes

Shape487 No




If yes, describe. Add additional sheets as needed.









8.

Shape489 Shape488 Are animals restrained for experimental manipulation? Yes No




If no, explain.




Shape490













9.

Shape492 Shape491 Are experimentally infected animals monitored (e.g., daily checks)? Yes No




If no, explain.




Shape493












10.

Describe animal housing for each species, including whether cages provide primary containment and a brief description (e.g. cage or cage rack is HEPA filtered, active or passive ventilation of the cages, non-containment caging housed within inward flow ventilated enclosure).



Species


Animal Housing


















11.

Describe how animals will be euthanized. Add additional sheets as needed.













12.

Are animals euthanized?

Shape494 Yes

Shape495 No




If no, explain.













13.

Describe how animal carcasses are secured prior to decontamination.





Shape496

Locked freezers, coolers



Shape497

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



Shape498

Other _____________________________________________________



This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):


Laboratory Safety Level:


Attachment D – Work with Plants



1.

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




Select Agent

Species of Plant

Route(s) of Inoculation














2.

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

Shape499 Yes

Shape500 No


Shape501

Autoclaved


Shape502

Chemical (disinfectant, concentration, and time) ___________________________________


Shape503

Irradiation


Shape504

Incineration


Shape505

Other ________________________________





3.

Are vectors present?

Shape506 Yes

Shape507 No


a.

Vectors are restricted to cages?

Shape508 Yes

Shape509 No


b.

Are adjacent areas monitored to observe potential escapes?

Shape510 Yes

Shape511 No


c.

Please describe vector species and cage mesh size __________________________


d.

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

Shape512 Yes

Shape513 No




If yes, complete Attachment E - Work with Arthropods.







4.

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

Shape514 Yes

Shape515 No


a.

Is the glass house attached to the laboratory?

Shape516 Yes

Shape517 No


b.

Is the glass house separated from the laboratory?

Shape518 Yes

Shape519 No


c.

Is pest monitoring conducted within the glass house?

Shape520 Yes

Shape521 No


d.

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

Shape522 Yes

Shape523 No


e.

Structure is reinforced.

Shape524 Yes

Shape525 No


f.

Floor is constructed of:





Shape526

Concrete





Shape527

Tile or other floor covering





Shape528

Dirt or gravel







5.

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

Shape529 Yes

Shape530 No


a.

Is the greenhouse attached to the laboratory?

Shape531 Yes

Shape532 No


b.

Is the greenhouse separated from the laboratory?

Shape533 Yes

Shape534 No


c.

Is pest monitoring conducted within the greenhouse?

Shape535 Yes

Shape536 No


d.

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

Shape537 Yes

Shape538 No


e.

Structure is reinforced.

Shape539 Yes

Shape540 No


f.

Floor is constructed of:





Shape541

Concrete





Shape542

Tile or other floor covering





Shape543

Dirt or gravel






This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):


Laboratory Safety Level:


Attachment D – Work with Plants (Continued)



6.

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

Shape544 Yes

Shape545 No


a.

Is the screenhouse attached to the laboratory?

Shape546 Yes

Shape547 No


b.

Is the screenhouse separated from the laboratory?

Shape548 Yes

Shape549 No


c.

Is pest monitoring conducted within the screenhouse?

Shape550 Yes

Shape551 No


d.

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

Shape552 Yes

Shape553 No


e.

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




f.

Structure is reinforced.

Shape554 Yes

Shape555 No


g.

Floor is constructed of:





Shape556

Concrete





Shape557

Tile or other floor covering





Shape558

Dirt or gravel







7.

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

Shape559 Yes

Shape560 No


a.

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

Shape561 Yes

Shape562 No


b.

Is the growth chamber separated from the laboratory?

Shape563 Yes

Shape564 No


c.

Is pest monitoring conducted within the growth chamber?

Shape565 Yes

Shape566 No


d.

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

Shape567 Yes

Shape568 No


f.

Structure is reinforced.

Shape569 Yes

Shape570 No


g.

Floor is constructed of:





Shape571

Concrete





Shape572

Tile or other floor covering





Shape573

Dirt or gravel




h.

Manufacturer name _____________________ Model number __________________


i.

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

Shape574 Yes

Shape575 No


j.

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

Shape576 Yes

Shape577 No






8.

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

Shape578 Yes

Shape579 No



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






This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):


Laboratory Safety Level:


Attachment E – Work with Arthropods


1.

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

Shape580 Yes

Shape581 No





2.

Work is performed to experimentally inoculate or infect arthropods (any stages) with select agents.

Shape582 Yes

Shape583 No




If yes, complete questions 3-16.










3.

Provide the select agent and species of arthropod used:






Select Agent

Species of Arthropod













4.

Arthropod experimental exposure route(s).





a.

Injected with select agent.

Shape584 Yes

Shape585 No



b.

Infected with select agent via blood meal.

Shape586 Yes

Shape587 No




If yes, indicate the blood meal source.






Shape588

Animal species ___________________________________





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

Shape589 Yes

Shape590 No





If yes, complete Attachment C - Work with Animals.





If no, explain. Add additional sheets as needed.











Shape591

Collected blood (describe type/method) ______________________________



c.

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

Shape592 Yes

Shape593 No




If yes, complete Attachment D - Work with Plants.



d.

Other (Describe) _____________________________________________________







5.

Provide a description of the procedures used for primary containment and any transfer(s) of infected arthropods. Add additional sheets as needed.














6.

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

Shape594 Yes

Shape595 No




If yes, describe. Add additional sheets as needed.















7.

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

Shape596 Yes

Shape597 No







This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):


Laboratory Safety Level:


Attachment E – Work with Arthropods (Continued)


8.

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

Shape598 Yes

Shape599 No


If yes,




a.

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

Shape600 Yes

Shape601 No


b.

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

Shape602 Yes

Shape603 No


If no, explain. Add additional sheets as necessary.












9.

Arthropods are prevented from release into suite/room.

Shape604 Yes

Shape605 No



If yes, do procedures include protocol for accidental escape?

Shape606 Yes

Shape607 No






10.

Experimentally infected arthropods are housed and manipulated in a suite/room such that accidental contact and release is prevented.

Shape608 Yes

Shape609 No






11.

Ventilation filters/barriers are installed to prevent arthropod escape.

Shape610 Yes

Shape611 No






12.

Floor drains are present in the laboratory.  

Shape612 Yes

Shape613 No



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

Shape614 Yes

Shape615 No






13.

Suite/room plumbing is suitable to prevent arthropod escape.

Shape616 Yes

Shape617 No






14.

All stages of arthropods are killed before disposal.

Shape618 Yes

Shape619 No






15.

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

Shape620 Yes

Shape621 No



If yes, describe method:





Shape622

Autoclaved



Shape623

Chemical (disinfectant, concentration, and time) _________________________________



Shape624

Incineration



Shape625

Other ___________________________________________________________________



16.

Animals or plants are permitted in the arthropod containment laboratory.

Shape626 Yes

Shape627 No


If yes,




a.

are animals or plants associated with the work being performed?

Shape628 Yes

Shape629 No


b.

are animals or plants accessible to escaped arthropods?

Shape630 Yes

Shape631 No



This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):



Attachment F – BSL3Ag Laboratories


1.

Supplies, material and equipment enter and exit BSL3Ag areas only through an airlock, fumigation chamber, an interlocked and double-door autoclave, or shower.

Shape632 Yes

Shape633 No



For materials which are temperature sensitive, a gas sterilizer, pass-through liquid dunk tank, or a cold gas decontamination chamber are provided.

Shape634 Yes

Shape635 No





2.

Is a shower required when leaving the containment boundary

Shape636 Yes

Shape637 No






3.

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

Shape638 Yes

Shape639 No


Shape640

Autoclaved




Shape641

Chemical (disinfectant, concentration, and time) _____________________________


Shape642

Incineration __________________________________________________________


Shape643

Other _______________________________________________________________





4.

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

Shape644 Yes

Shape645 No





5.

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

Shape646 Yes

Shape647 No





6.

There is HEPA filtration of all supply and exhaust air to and from the containment space.

Shape648 Yes

Shape649 No



If yes, all HEPA filters are certified annually.

Shape650 Yes

Shape651 No





7.

Laboratory procedure and design features include:




a.

Personnel ingress and egress only through a series of rooms which includes a ventilated vestibule.

Shape652 Yes

Shape653 No


b.

A clean change room outside of containment.

Shape654 Yes

Shape655 No


c.

Doors that define a containment boundary have compressible or inflatable gaskets with airtight hinges and latch/knob areas.

Shape656 Yes

Shape657 No


d.

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

Shape658 Yes

Shape659 No


e.

A dirty change room within containment.

Shape660 Yes

Shape661 No





8.

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

Shape662 Yes

Shape663 No



This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):



Attachment F – BSL3Ag Laboratories (Continued)


9.

Humane restraining devices are provided in large animal rooms.

Shape664 Yes

Shape665 No


If yes, describe. Add additional sheets as needed.













10.

Necropsy rooms are sized and equipped to accommodate large animals.

Shape666 Yes

Shape667 No


If yes, describe. Add additional sheets as needed.











This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):



Attachment G – BSL4/ABSL4 Laboratories


BSL4 Laboratory


1.

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

Shape668 Yes

Shape669 No



If yes, complete questions 2 - 8


2.

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




3.

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




4.

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




5.

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




6.

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




7.

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




8.

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




9.

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

Shape670 Yes

Shape671 No



If yes, complete questions 10 - 16


10.

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




11.

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





This submission is:

A new registration

An update to an existing registration

A renewal

Entity Name:

Date:

PI(s):



Attachment G – BSL4/ABSL4 Laboratories (Continued)


12.

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




13.

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




14.

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




15.

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




16.

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
























File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorKowalski, Matthew (CDC/OPHPR/DSAT) (CTR)
File Modified0000-00-00
File Created2021-01-21

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