Attachment 5 - List of revisions to forms

APHIS/CDC FORMS REVISIONS

I. Global Changes to All Forms

1. Reformatted the contact information for APHIS and CDC to:

Animal and Plant Health Inspection Service Centers for Disease Control and Prevention

Agricultural Select Agent Program Division of Select Agents and Toxins

4700 River Road Unit 2, Mailstop 22, Cubicle 1A07 1600 Clifton Road NE, Mailstop A-46

Riverdale, MD 20737 Atlanta, GA 30333

FAX: 301-734-3652 FAX: 404-718-2096

E-mail: [email protected] Email: [email protected]

2. Updated CDC’s contact information for mailstop, telephone and fax.

3. Corrected editorial or formatting errors from previous submission.

4. Added to National Select Agent Registry web address (http://www.selectagents.gov)

5. Added the “#” after Fax and Telephone and “address” after email in blocks on form.

6. Deleted “For HHS agents and toxins, the applicant should contact CDC (telephone: 404-498-2255; facsimile: 404-498-2265; or e-mail: [email protected]). For HHS/USDA overlap agents, the applicant should contact either APHIS or CDC. For USDA agents and toxins, the applicant should contact APHIS (telephone: 301-734-5960; facsimile: 301-734-3652; or e-mail: [email protected]). A listing of HHS select agents and toxins is available at http://www.cdc.gov/od/sap. A listing of USDA select agents and toxins is available at http://www.aphis.usda.gov/programs/ag_selectagent/index.html.”

7. Renumbered blocks to coordinate changes with forms.

8. In the address header for the forms, added the email addresses for CDC and APHIS.

9. Changed “Legal name of entity” in form blocks to “Entity name.”

10. In the “Obtaining Extra Copies of this Form” section revised the language for consistency purposes to read “To obtain additional copies of this form, contact APHIS at (301) 734-5960 or CDC at (404) 718-2000. This guidance document and form are also available at http://www.selectagents.gov, http://www.aphis.usda.gov/programs/ag_selectagent/index.html and http://www.cdc.gov/od/sap.”

II. APHIS/CDC Form 1, “Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins”

1. Introduction Section

1. Deleted 3^rd and 4^th paragraphs that stated “The entity should also perform a facility risk assessment (see 7 CFR 331.11-12, 9 CFR 121.11-12, and 42 CFR 73.11-12) that is based on the requirements for handling that agent to ensure that the facility meets those requirements. All entities using select agents and toxins should base their facility risk assessments on the applicable sections of the Biosafety in Microbiological and Biomedical Laboratories (BMBL), NIH Guidelines for Research Involving Recombinant DNA (NIH Guidelines), 29 CFR 1910.1450, or other required assessment materials. If information supplied in the application package indicates that the entity is properly equipped and capable of handling select agents and toxins, APHIS or CDC may issue a registration certificate to the entity. The registration is valid for a period up to three years. All entities will be subject to inspection during the three-year registration period.

If an entity’s application fails to document that the entity is properly equipped and capable of work with select agents and toxins, or if the application is incomplete, the entity will not be registered. APHIS or CDC will inform the entity of problems with the application by contacting the designated RO. Upon resolution of the problem, the entity may again seek registration. Allow at least 8 weeks for processing. Submission of an incomplete application will result in a significant delay in processing the application. Currently, there is no fee for registration for select agents and toxins.”

2. Added this statement as the last sentence of the section: “The registration is valid for a period up to three years. All entities will be subject to inspection during the three-year registration period.”

B. Revised the Instruction Section to read: “(A) Designating a RO and alternate RO

The entity is required by the regulations to assign a Responsible Official (RO). The RO must have the authority and responsibility to act on behalf of the entity, ensure compliance with the requirements of 7 CFR 331, 9 CFR 121, and 42 CFR 73, and must be approved based on a security risk assessment (SRA) by the Attorney General (Public Act 212(e)(3)). The purpose of the RO is to provide an established point of contact for the entity if APHIS or CDC has questions concerning the application or other matters related to the entity registration. The RO should consult with others (e.g., engineering support services, principal investigators, biosafety officers) as necessary to obtain the information required for this application prior to submitting the form to APHIS or CDC.

An entity may also designate an alternate RO in cases where extended absences or other circumstances warrant acting for the RO in his or her absence. The alternate RO must meet all of the qualifications for a RO. We recommend that the RO and alternate RO are biosafety officers or senior management officials of the entity, or both. Although we understand that some entities have limited staff, we recommend that the RO not be an individual actually using, working with, or transferring or receiving the select agents and toxins to minimize potential conflicts of interest.

To designate a different RO or an alternate RO, the current RO must mail, fax, or email to the same agency that you filed your original application with (APHIS or CDC) a signed statement on official entity facility letterhead requesting such changes. In addition, the new RO or alternate RO must submit completed Sections 1 and 2.

In the event that an entity loses the services of its RO, an entity may continue to possess, use, or transfer select agents or toxins only if it appoints as the RO another individual who has been approved by the APHIS Administrator or HHS Secretary following a security risk assessment by the Attorney General and who meets the requirements of the regulations. The owner of the entity must mail, fax, or email to the appropriate agency a signed statement on official entity facility letterhead requesting such changes. In addition, the new RO or alternate RO must submit Sections 1 and 2.

(B) Completing Application

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

2. Section 1 – Entity Information

1. Indicate in Section 1 if the submission is for a “new registration” or an “amendment to an existing registration.”

2. Section 1A should contain information regarding the physical location of the entity.

3. Section 1B should contain information regarding the RO.

4. Section 1C should contain information regarding the alternate RO information. If more than one alternate RO has been identified, additional sections 1C and 2 should be completed, as appropriate.

5. If the entity was previously registered with APHIS or CDC, section 1D should be completed.

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

4. Section 3 – Entity Summary. Complete section to indicate each select agent (genus and species) or toxin which is currently in possession at the entity. Include all select agents and toxins not currently in possession but which the entity plans to possess in the future. Record the building and room number where the select agents will be used or stored for each Principal Investigator (Chief Scientist) who will be using and storing the select agents and toxins. Do not include toxins that the entity will never possess above the excluded amount. The Principal Investigator listed should be that individual who has responsibility over the use and disposition of the select agents and toxins.

1. Section 4 – Entity’s Personnel Information. Complete this section by providing the information for the RO, alternate RO, owners of the entity, as well as each person who is authorized to have access (possession or the ability to gain possession) to select agents and toxins at the entity. If multiple pages are submitted, the RO only needs to sign the last page indicating that the listed individuals who will have access to select agents and toxins have received the appropriate training.

1. The name (including middle initial) and the date of birth for individuals listed on this table should be identical to that given on the FBI form (FD-961) submitted to the Federal Bureau of Investigation (FBI), Criminal Justice Information Services Division (CJIS) for each individual.

2. The individuals who have been identified as RO, ARO, owners of the entity, and Principal Investigator (PI) should be listed as that for their job title. For example, the RO would be listed as the “Responsible Official” for the job title.

3. The “Principal Investigator” field for this section refers to the individual who is supervising all activities associated with the select agents and toxins. If individual(s) will be supervised by all PIs at your entity, indicate “all” under the “Principal Investigator” column. This column should be left blank only for the RO, ARO, PI, and owner/controller of the entity.

4. Amending Section 4:

1) To request an individual to be added to Section 4, submit an amended Section 4 with the individual’s information added to the same agency that you filed your original application with (APHIS or CDC). For submitting the security risk assessment (SRA) information to CJIS:

1. Once the entity has submitted an amended Section 4 listing new persons requiring an SRA, the RO receives the individual’s unique Department of Justice (DOJ) identifying number from APHIS or CDC and forwards to the individual to complete the SRA information (FD-961 form and fingerprint cards).

2. The individual should complete the FD-961 form including their unique DOJ identifying number in the “Unique Identifier Number” block and follows the FBI instructions (http://www.fbi.gov/hq/cjisd/takingfps.html) for submitting fingerprints. The FD-961 form and fingerprint cards should be mailed as one package directly to CJIS, not to APHIS or CDC. Specific guidance on the process is available at http://www.selectagents.gov, http://www.aphis.usda.gov/programs/ag_selectagent/index.html, http://www.cdc.gov/od/sap, or http://www.fbi.gov/terrorinfo/bioterrorfd961.htm.

2) To request individual’s access to be terminated, submit the Section 4 with the individual’s information lined through or removed include a cover letter indicating the reason for termination of the individual’s access to the same agency that you filed your original application with (APHIS or CDC).

Example: John Johnson will be working with viable Bacillus anthracis in Bldg A, Room 2 at BSL-2 in Dr. Jane Doe’s laboratory. Although Dr. Jane Doe may not be his immediate supervisor, her name should be listed because she is responsible for the select agent in this laboratory.

Last Name	First Name	Middle Initial	Date of Birth (mmddyr)	Job Title	Principal Investigator (PI’s, RO’s, ARO’s, and owners leave this column blank)
Doe	Jane	A.	1/1/61	Principal Investigator
Johnson	John	D.	1/2/60	Laboratorian	Doe

5. Section 5 – Select Agent Requirements. Complete section to indicate that your entity has the implemented plans or procedures to ensure compliance with the requirements of 7 CFR 331, 9 CFR 121, and 42 CFR 73. A Section 5 should be completed for each PI identified in Section 4.

   1. Section 5A must be completed to describe the security measures put in place at your entity to ensure compliance with Section 11 of the regulations. Informational documents have been developed to assist in the development and implementation of the written security plan. The referenced documents are available at http://www.selectagents.gov, http://www.aphis.usda.gov/programs/ag_selectagent/index.html and http://www.cdc.gov/od/sap.

   2. Section 5B must be completed to explain the biosafety and incident responses procedures put in place at your entity to ensure compliance with Sections 12 and 14 of the regulations.

   3. Section 5C must be completed to describe the training procedures put in place at your entity to ensure compliance with Section 15 of the regulations.

   4. Section 5D must be completed to detail how your entity ensures records and databases are accurate and maintained to ensure compliance with Section 17 of the regulations.

7. Section 6 – Biosafety and Laboratory Information on Select Agents and Toxins. Complete this section for each PI at the entity. Complete only sections as appropriate for the select agents and toxins in use under the control of each PI.

   1. For Section 6A, the following information must be listed on a separate line for each laboratory safety level: the select agent or toxin; the strain designation of the select agent or toxin, the building and room number(s) where each select agent or toxin will be used and stored, and laboratory safety level for each PI (or Chief Scientist). The PI is the one 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. If your entity has delegated more than one person as the PI, the RO should designate one individual as the primary person and the additional individuals should be listed in question #2 in Section 6B. For all select agents and toxins that are not currently in possession but which the entity plans to possess in the future, please indicate “TBA” in the strain designation column to note that the agent or toxin is to be acquired.

1) The strain designation for the select agent and toxin should be listed if known. If your entity does not perform strain designation, then you would list “N/A” for this column. For select agents that have been genetically modified such as introduction of an antibiotic resistant gene, you would note that in the strain designation column. In addition, you would need to provide information regarding these experiments in Section 6D.

2) The entity should perform a facility risk assessment for each agent possessed (see 7 CFR 331.11-12, 9 CFR 121.11-12, and 42 CFR 73.11-12) that is based on the requirements for handling the agent to ensure that the facility meets those requirements. All entities using select agents and toxins should base their facility risk assessments on the applicable sections of the Biosafety in Microbiological and Biomedical Laboratories (BMBL), NIH Guidelines for Research Involving Recombinant DNA (NIH Guidelines), 29 CFR 1910.1450, or other required assessment materials. The facility risk assessment based on the requirements for the type of activities conducted with each select agent and toxin in each of the rooms should be listed in the “Laboratory Safety Level” column. The resources/references used for the facility risk assessment must be described in question #36 in Section 6G.

3) For entities only storing and not actively working with select agents or toxins, do not complete “laboratory area” column.

Example: An entity needs to register one PI (e.g., Dr. Jane Doe will be working with the Ames strain of Bacillus anthracis and experiments that involve the introduction of plasmids containing kanamycin resistance cassettes used as selectable markers in Yersinia pestis in Bldg 1, Room 100 at BSL-3. Dr. Doe is storing Bacillus anthracis (strain unknown) in hopes of a future grant). Storage of the select agents will be in the same locations where the work will be conducted.

Select Agent/Toxin	Strain Designation (list “N/A” if not applicable or “TBA” if to be acquired)	Laboratory Area		Storage Area		Laboratory Safety Level*	Principal Investigator
		Bldg	Room	Bldg	Room
Bacillus anthracis	Ames	1	100	1	100	BSL3	Doe
Bacillus anthracis	N/A			1	100	BSL3	Doe
Yersinia pestis	Kanamycin resistance	1	100	1	100	BSL3	Doe

b. Complete sections 6B-6F to describe the work for each select agent or toxin listed in Section 6A under the control of the PI including a description of the methodologies or laboratory procedures that will be used. For example, if the research involves experiments introducing an antibiotic resistant gene into a select agent and then performing aerosol challenges in mice, you would need to describe this research by completing sections 6B, 6D, and 6E. If no work is being performed on each select agent or toxin listed in Section 6A, then indicate “storage only” for Question #1 and skip to Section 6G.

c. Complete Section 6G for each laboratory under a different biosafety level listed in Section 6A where select agents or toxins are used or stored.

1) For any laboratory that is not operational, indicate “No” for question #33 and note this on the floor plan including the anticipated certification or commission date of the laboratory.

2) For question #35, indicate which references or resources was used to perform a facility risk assessment that is based on the requirements for handling that agent to ensure that the facility meets those requirements.

4. Complete 6H and 6I for any work that will be performed in a laboratory considered a “BSL-3 Ag,” BSL-4” or “ABSL-4” laboratory.”

C. For the form,

1. Revised Section 3 to:

This application is:  A new registration  An amendment to an existing registration	Date
Legal name of entity:	Entity registration number (e.g., A00000000-0000):

SECTION 3 – ENTITY SUMMARY
(TO BE COMPLETED BY RO)

Provide the following information on a separate line for each select agent or toxin and the building and room number(s) where each select agent or toxin will be used/stored for each PI (or Chief Scientist). Select agents or toxins that are exempt or excluded from registration should not be listed on this form. For information on completing this section, refer to page 2 of the guidance document. A listing of select agents and toxins is available at http://www.selectagents.gov, http://www.aphis.usda.gov/programs/ag_selectagent/index.html and http://www.cdc.gov/od/sap

Select Agent/Toxin	Laboratory Area		Principal Investigator
	Bldg	Room

2. Change Section 4 to:

This application is:  A new registration  An amendment to an existing registration	Date
Legal name of entity:	Entity registration number (e.g., A00000000-0000):

SECTION 4 – ENTITY’S PERSONNEL INFORMATION

(TO BE COMPLETED BY RO)

Provide the information in the following table (Last Name, First Name, Middle Initial, Date of Birth, Job Title, PI for each individual employed by the entity that has access to the select agents and toxins. The RO, ARO, owners of the entity, and PI should be listed as that instead of their official institution title. (Example, The RO would be listed as "RO" not biosafety officer in the Job Title column.) Each person should list the PI who controls the use of the select agents and toxins that the person will work with. If the person will work with all PIs the term "All" should be listed in the PI column. The name (including middle initial) and the date of birth for individuals listed on this table should be identical to that given on the FD-961 Form submitted to CJIS for each individual. To request additions to, or deletions from, this list of individuals submit this Section to the agency that you filed your original application with (APHIS or CDC). If multiple pages are submitted, the RO will only need to sign the last page. For additional information on completing this section, refer to page 2 (B)(5) of the application instructions.

Last Name	First Name	Middle Initial	Date of Birth (mmddyr)	Job Title	Principal Investigator (PI’s, RO’s, ARO’s, and owners leave this column blank)

I certify that information and training on safety and security for working with select agents and toxins has been provided to the individuals listed above who will have access to select agents and toxins.

RO/ARO Signature:_________________________________________________ Date: _______________

3. Change Section 5 to:

This application is:  A new registration  An amendment to an existing registration	Date
Legal name of entity:	Entity registration number (e.g., A00000000-0000):

SECTION 5 – ENTITY’S SELECT AGENT REQUIREMENTS (TO BE COMPLETED BY RO)

This section should be completed by the RO during the initial request for a certificate registration and any time there is a change in the entity’s procedures noted in Section 5. For information on completing this section, refer to page 3 (B)(6) of the guidance document.

SECTION 5A – SECURITY

1. Each laboratory has a site-specific written security plan:  Yes  No

1. Plan designed according to a site-specific risk assessment and provides graded protection

in accordance with the risk of select agent or toxin:  Yes  No

2. Plan contains all information as required by the Select Agent Regulations:  Yes  No

3. The plan is reviewed annually and revised as necessary:  Yes  No

4. Drills or exercises are conducted to validate or test the effectiveness of the plan:  Yes  No

2. Physical Security (check all that apply):

1. Means to limit access to buildings with select agents and toxins:
    Guard station at the building entrance
    Locks

 Card access system
 Biometric system

 Intrusion detection system

 Other (describe): ________________________________________________________________________

2. Means to limit access to rooms with select agents and toxins:

 Locks

 Card access system
 Biometric system

 Intrusion detection system

 Other (describe): ________________________________________________________________________

3. Means to limit access to select agents and toxins inside the room:
    Locked incubators, refrigerators, freezers, etc.
    Locked box inside incubators, refrigerators, freezers, etc.

 Biometric system

 Card access system

 Intrusion detection system

 Other (describe): ________________________________________________________________________

4. Means to monitor access to areas where select agents and toxins are used or stored:
    Electronic logs of access
    Manual sign in logs

 Video camera surveillance
 Other (describe): ________________________________________________________________________

5. Access to select agents and toxins is restricted to individuals that have access approval from the

APHIS Administrator or HHS Secretary:  Yes  No

6. Are individuals, not approved for access from the APHIS Administrator or HHS Secretary, allowed

access to an area with select agents and toxins without escort by approved individual?  Yes  No

7. The laboratory is secured when no one is present during regular working hours:  Yes  No

3. Suspicious packages are inspected prior to entry or removal from an area where select agents and

toxins are used or stored:  Yes  No

4. Select agents and toxins are transferred within the entity (intra-entity transfers):  Yes  No

1. Intra-entity transfer is only under the supervision of an individual with access approval from

APHIS Administrator or HHS Secretary:  Yes  No

2. Chain-of-custody documents are used for intra-entity transfers:  Yes  No

5. Select agents and toxins are transferred from an individual approved to have access to select agents

and toxins directly to a licensed commercial courier services or from a licensed commercial courier

service:  Yes  No

Note: The transfer must be from the approved person to the courier or vice versa not between the courier and the shipping area.

SECTION 5B – BIOSAFETY AND INCIDENT RESPONSE

6. Each laboratory has a written agent-specific, site-specific biosafety plan:  Yes  No

1. The plan is commensurate with the risk of the select agent and toxin and contains all

information as required by the Select Agent Regulations:  Yes  No

2. The plan is reviewed annually and revised as necessary:  Yes  No

3. Drills or exercises are conducted to validate or test the effectiveness of the plan:  Yes  No

7. Personal protective equipment (PPE) recommended for the agents and the work performed

is required:  Yes  No

8. A medical surveillance system is in place for personnel using the select agents and toxins:  Yes  No

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

reported to the Responsible Official:  Yes  No

10. There are policies for the handling of sharps:  Yes  No

11. An Institutional Biosafety Committee (IBC) reviews and approves protocols prior to work with

select agents and toxins at this facility?  Yes  No  N/A

If yes, has the IBC approved the work proposed in this application:  Yes No

If no, please attach an explanation.

12. The facility has been inspected by USDA, HHS, CLIA, DoE, DoD or others:  Yes No

If yes, please add attachment listing inspection organization/agency name and date of last inspection.

13. Each laboratory has a written incident response plan:  Yes  No

1. The plan is commensurate with the hazards of the select agent and toxin and contains

all information required by the Select Agent Regulations:  Yes  No

2. The plan is reviewed annually and revised as necessary:  Yes  No

3. Drills or exercises are conducted to validate or test the effectiveness of the plan:  Yes  No

SECTION 5C – TRAINING

14. Training:

a. Security and biosafety training is provided prior to individual’s access to areas where select agents

and toxins are handled or stored:  Yes  No

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

select agents and toxins:  Yes  No

c. Refresher training is provided:  Annually  Biannually  Other (specify frequency): __________________

d. Written records of individuals trained are maintained:  Yes  No

e. Personnel are required to demonstrate proficiency in laboratory procedures prior to working with select agents and

toxins:  Yes  No

f. Provide a brief description of what is included in the training program:

• Biosafety: ______________________________________________________________________________

• Incident Response: _______________________________________________________________________

• Security: _______________________________________________________________________________

• Other: _________________________________________________________________________________

g. Describe the means used to verify that individuals understood the training (add additional sheets as necessary): __________________________________________________________________________________________
__________________________________________________________________________________________

SECTION 5D – RECORDS AND INFORMATION SYSTEMS CONTROL

15. Records specified in Section 17 of the Select Agent Regulations are maintained and current:  Yes  No

16. Provide a brief explanation of the system in place that ensures records and databases are accurate, their

authenticity may be verified, and explains any discrepancies:

__________________________________________________________________________________________

__________________________________________________________________________________________

17. Describe the means to control access to manual records that would allow for access to select agents and toxins (check all that apply):

 Locks

 Locked filing cabinet, drawer, cabinet, etc.

 Card access system
 Other: __________________________________________________________________________________

18. Describe the means to control access to electronic records and database that would allow access to select agents and

toxins (check all that apply):

 Locks

 Card access system

 Password protected

 Firewall protection

 Antivirus protection

 Other: ________________________________________________________________________________
 Network System [inter/intranet]

 Not connected to a network (stand alone system)

________________________________________________________________________________

19. Name(s) of Individual(s) responsible for inventory of select agent(s) and toxin(s): _____________________________

1. Inventory record is reconciled:  Annually  Biannually  Other (specify frequency): _________________

2. Inventory tracking includes the following information (list): __________________________________________

__________________________________________________________________________________________

__________________________________________________________________________________________

3. Added Section 6:

This application is:  A new registration  An amendment to an existing registration	Date
Legal name of entity:	Entity registration number (e.g., A00000000-0000):

SECTION 6 – BIOSAFETY AND LABORATORY INFORMATION ON SELECT AGENTS AND TOXINS

Make additional copies of this section of the form as needed for each PI at your entity. Each PI should complete the appropriate section for laboratories under his/her control where select agents are used or stored. For information on completing this section, refer to page 3 (B)(7) of the guidance document.

SECTION 6A – TO BE COMPLETED BY ALL ENTITIES FOR EACH PRINCIPAL INVESTIGATOR

Provide the following information on a separate line for each laboratory safety level: the select agent or toxin; the strain designation of the select agent or toxin, the building and room number(s) where each select agent or toxin will be used and stored, and laboratory safety level for each PI (or Chief Scientist). For entities only storing and not actively working with select agents or toxins, do not complete “laboratory area” column. For information on completing this section, refer to page 3 (B)(7) of the guidance document.

Select Agent/Toxin	Strain Designation (list “N/A” if not applicable or “TBA” if to be acquired)	Laboratory Area		Storage Area		Laboratory Safety Level*	Principal Investigator
		Bldg	Room	Bldg	Room

This application is:  A new registration  An amendment to an existing registration	Date
Legal name of entity:	Entity registration number (e.g., A00000000-0000):

SECTION 6B – TO BE COMPLETED FOR EACH PRINCIPAL INVESTIGATOR WORKING WITH SELECT AGENTS/TOXINS

1. Provide the objectives of the work for each select agent or toxin listed in Section 6A, including a description of the

methodologies or laboratory procedures that will be used. Each PI should also complete each sub-

section as appropriate for this work. If no work is being performed on select agent or toxin, indicate storage only.

For information on completing this section, refer to page 4 of the guidance document. Attach additional sheets if needed:

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

_______________________________________________________________________________________________

2. Additional PIs performing the same objective of work:  Yes  No

If yes, list: _______________________________________________________________________________________

3. Provide an estimate of the maximum quantities (e.g., number of petri dishes or total volume of liquid media) and

concentration of each organism grown at a given time (e.g., 2 - 250 ml flasks of 10⁵ cfu/ml). If select agent will not be

propagated, then indicate “no propagation of agent”. Attach additional sheets if needed:

1. Agent/Toxin: ________________________ Maximum Quantities: ______________________________________

2. Agent/Toxin: ________________________ Maximum Quantities: ______________________________________

3. Agent/Toxin: ________________________ Maximum Quantities: ______________________________________

4. Agent/Toxin: ________________________ Maximum Quantities: ______________________________________

4. All cultures, stock and other regulated wastes are decontaminated before removal from the

containment area:  Yes  No

If yes, describe method:

 Autoclaved (temperature, time, and psi):________________________________________________________

 Chemical (disinfectant, concentration, and time): _________________________________________________

 Irradiation: _______________________________________________________________________________

 Other:___________________________________________________________________________________

SECTION 6C –WORK WITH toxins

5. Will work be performed with toxins or with agents that produce regulated amounts of toxins?  Yes  No

If yes, complete questions 6 – 10.

6. A Chemical Hygiene Plan is available for the laboratory using toxins:  Yes  No

7. The toxin is produced by viable agent at the entity:  Yes  No

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

8. Dilution procedures and other manipulations of the concentrated toxins are performed:  Yes  No

1. If yes, conducted in:  Fume hood  Biological safety cabinet

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

3. Work is conducted with two knowledgeable people present:  Yes  No

9. A hazard sign is posted on the door when toxins are in use:  Yes  No

10. All cultures, stock and other regulated wastes are decontaminated before removal from the

containment area:  Yes  No

If yes, describe method:

 Autoclaved (temperature, time, and psi):________________________________________________________

 Chemical (disinfectant, concentration, and time): _________________________________________________

 Irradiation: _______________________________________________________________________________

 Other:___________________________________________________________________________________

SECTION 6D –WORK WITH GENETIC ELEMENTS, RECOMBINANT NUCLEIC ACIDS, OR RECOMBINANT ORGANISMS

11. Will work be performed with genetic elements,  Yes  No

recombinant nucleic acids,  Yes  No

recombinant organisms, or  Yes  No

antibiotic resistant select agents?  Yes  No

If yes, complete questions 12 – 16.

12. Will you be possessing, using or transferring the following:

1. Nucleic acids that can produce infectious forms of any of the select agent viruses.  Yes  No

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

1) can be expressed in vivo or in vitro.  Yes  No

2) are in a vector or recombinant host genome and can be expressed in vivo or in vitro.  Yes  No

c. Select agent viruses, bacteria, fungi, and toxins that have been genetically modified.  Yes  No

13. Provide a brief description of the recombinant constructs and any associated expression control elements, including

what the recombinant DNA encodes for, if known: _____________________________________________________

14. Give an estimate of range of length of recombinant DNA to be used: _______________________________________

15. Are you intending to conduct experiments that introduce antibiotic resistance markers/traits into select agents/toxins:  Yes  No

If yes, provide the agent/toxin and antibiotic being used:

1. Select Agent/Toxin: ________________________ Antibiotic: __________________________

2. Select Agent/Toxin: ________________________ Antibiotic: __________________________

3. Select Agent/Toxin: ________________________ Antibiotic: __________________________

16. Will experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD₅₀ < 100 ng/kg body weight:  Yes  No

If yes, list toxin and provide a brief description of the restricted experiment: ___________________________________

_______________________________________________________________________________________________

Note: An individual or entity may not conduct a restricted experiment as defined under 7 CFR 331.13, 9 CFR 121.13, and 42 CFR 73.13 unless approved by the APHIS Administrator and HHS Secretary.

SECTION 6E – WORK WITH ANIMALS

17. Will work be performed with animals?  Yes  No

If yes, complete questions 18 – 22.

18. Provide the agent/toxin and animal being used:

1. Select Agent/Toxin: ____________ Species of Animal: _____________ Route of Administration: ______________

2. Select Agent/Toxin: ____________ Species of Animal: _____________ Route of Administration: ______________

3. Select Agent/Toxin: ____________ Species of Animal: _____________ Route of Administration: ______________

19. How are animal waste and animal carcasses treated prior to disposal (e.g., carcasses, sewage, bedding, etc.) by an approved method:

• Not treated

• Autoclaved (temperature, time, and psi):__________________________________________________________

• Chemical (disinfectant, concentration, and time): ___________________________________________________

• Irradiation: _________________________________________________________________________________

• Other:_____________________________________________________________________________________

20. The entity requires that an Institutional Animal Care and Use Committee (IACUC) review and approve
protocols prior to work with animals at this entity:  Yes  No

If yes, the proposed work with select agents and toxins in animals has been approved by the IACUC:  Yes  No

21. The laboratory is accredited by the Association for Assessment and Accreditation of Laboratory

Animal Care (AAALAC):  Yes  No

If yes, give accreditation date: ___________________

22. Is there a system in place for recording the number of animals received and the number of animals

disposed of and are the records reviewed frequently?  Yes  No

If yes, please describe: ____________________________________________________________________________

SECTION 6F – WORK WITH PLANTS

23. Will work be performed with plants?  Yes  No

If yes, complete questions 24 – 37.

24. Provide the agent/toxin and plant being used:

1. Select Agent/Toxin: _____________ Species of Plant: _____________ Route of Administration: ______________

2. Select Agent/Toxin: _____________ Species of Plant: _____________ Route of Administration: ______________

3. Select Agent/Toxin: _____________ Species of Plant: _____________ Route of Administration: ______________

25. Work will be done in a glass or greenhouse:  Yes  No

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

 Laminated Glass  Tempered Glass  Polycarbonate  Other (describe): __________________________

26. Structure is reinforced:  Yes  No

27. Floor is concrete:  Yes  No

28. Vents into facility:  Yes  No

29. Floor drains:  Yes  No

30. Waste water collection and treatment, prior to release into sanitary sewer system:  Yes  No

31. Greenhouse HVAC supply and exhaust:

1. Negative air pressure is maintained inside greenhouse:  Yes  No

2. Greenhouse exhaust air is re-circulated to other areas of the facility:  Yes  No

If yes, HEPA filtration of all exhaust air is in place:  Yes  No

32. Vectors present:  Yes  No

If yes, vectors are restricted to cages:  Yes  No

33. Work will be done in growth chambers:  Yes  No

1. If yes, the growth chamber is integrated into the laboratory building structure:  Yes  No

2. If yes, the growth chamber is stand alone:  Yes  No

3. Manufacture name:____________________________ Model number: _____________________

34. Growth chamber has floor drains:  Yes  No

If yes, waste water is collected and treated prior to release into sanitary sewer system:  Yes  No

35. Growth chamber HVAC supply and exhaust:

1. Negative air pressure is maintained inside the growth chamber:  Yes  No

2. Growth chamber exhaust air is re-circulated to other areas of the facility:  Yes  No

If yes, HEPA filtration of all exhaust air is in place:  Yes  No

36. Plant waste is treated prior to disposal (e.g., soil, plant material, etc.) by an approved method:

• Not treated

• Autoclaved (temperature, time, and psi):__________________________________________________________

• Chemical (disinfectant, concentration, and time): ___________________________________________________

• Irradiation: _________________________________________________________________________________

• Other:_____________________________________________________________________________________

SECTION 6G –LABORATORY INFORMATION

This section should be completed for each laboratory safety level listed in Section 6A under the control of the PI.

37. Laboratory(ies) is/are currently operational:  Yes  No

If no, indicate on floor plan which laboratory/laboratories are not operational and the date of anticipated certification/commission of laboratory.

38. Include a floor plan for each laboratory under the control of the PI where select agents or toxins listed in Section 6A are to be used or stored (for all laboratory safety levels). Floor plan(s) for all laboratory safety levels include: entry into laboratory and locations of equipment (e.g., sink, eyewash, biological safety cabinets (BSC), fume hoods, freezer, refrigerator, incubator, centrifuges, autoclave, and incinerator), HVAC supply and exhaust, and cage washing area (if applicable).

39. A facility risk assessment was performed to determine biosafety level:  Yes  No

a. If yes, what was the determination:

 BSL2  BSL3  BSL4  ABSL2  ABSL3  BSL3 Ag  ABSL4

 Other: __­__________________________________________

b. List the resources/references used: _______________________________________________________________

______________________________________________________________________________________________

40. Define certification period for BSC located in laboratory:  Annual  Biannual  Other (explain):______________

41. Laboratory exhaust is re-circulated to other areas of the facility:  Yes  No

42. The laboratory is maintained at negative air pressure to provide directional air into the laboratory:  Yes  No

43. Laboratory is separated from open and unrestricted areas:  Yes  No

44. A visual system is provided for laboratory personnel to monitor directional air before entry and

during use of the laboratory:  Yes  No

45. An alarm system is provided to warn laboratory personnel of exhaust system failure:  Yes  No

46. HEPA filtration of all exhaust air is in place:  Yes  No

SECTION 6H – BSL3 AG LABORATORIES

47. Will work with animals be performed in BSL-3 Ag Laboratory?  Yes  No

If yes, complete questions 48 – 59.

48. Describe where infected animals will be housed during and after experiments:

__________________________________________________________________________________________

__________________________________________________________________________________________

49. Personnel assigned to work with infected animals work in pairs:  Yes  No

50. Aerosol experiments are conducted in this BSL-3 Ag laboratory:  Yes  No

51. There is a mandatory daily inspection of the containment parameters for the BSL-3 Ag laboratory

area(s) and critical life support systems:  Yes  No

52. Supplies, material and equipment enter BSL-3 Ag space only through an airlock, fumigation chamber,

and interlocked and double-door autoclave or shower.  Yes  No

53. All walls are constructed slab-to-slab and walls, floors, and ceilings of the BSL-3 Ag laboratory rooms

are sealed. All penetrations into the laboratory are sealed airtight to prevent escape of contained

agents and to allow gaseous fumigations for biological decontamination:  Yes  No

54. Bench tops are seamless or sealed surfaces that are impervious to water and resistant to

moderate heat and organic solvents, acids, alkalis, and other decontaminant chemicals:  Yes  No

55. Laboratory furniture is capable of supporting anticipated loads and uses and is covered with a

non-fabric material that can be easily decontaminated:  Yes  No

56. Differential pressures/directional airflow are monitored and alarmed (visually and audibly) to

indicate system failure:  Yes  No

57. There is HEPA filtration of all supply and exhaust air from the room(s), inner change room(s),

and anteroom(s):  Yes  No

If yes, all HEPA filters are tested and certified annually:  Yes  No

58. Appropriate communication systems are provided between the laboratory and external personnel

(intercom, phone, fax, and computer):  Yes  No

59. All drains in the cabinet room(s), inner change room(s), and autoclave chambers connect

directly to an appropriate liquid waste decontamination system:  Yes  No

If yes, describe method utilized for decontamination of BSL-3 Ag area(s):

__________________________________________________________________________________________

__________________________________________________________________________________________

SECTION 6I – BSL4/ABSL4 LABORATORIES

60. Will work be performed in BSL-4/ABSL-4 Laboratory?  Yes  No

If yes, complete questions 61 – 70.

61. There is a mandatory daily inspection of the containment parameters for the BSL-4 laboratory area(s)

and critical life support systems:  Yes  No

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

laboratory are sealed:  Yes  No

63. Bench tops are seamless or sealed surfaces that are impervious to water and resistant to

moderate heat and organic solvents, acids, alkalis, and other decontaminant chemicals:  Yes  No

64. Laboratory furniture is capable of supporting anticipated loads and uses and is covered with a

non-fabric material that can be easily decontaminated:  Yes  No

65. Differential pressures/directional airflow are monitored and alarmed (visually and audibly) to

indicate system failure:  Yes  No

66. There is HEPA filtration of all supply and exhaust air from the room(s), inner change room(s),

and anteroom(s):  Yes  No

If yes, all HEPA filters are tested and certified annually:  Yes  No

67. Appropriate communication systems are provided between the laboratory and external personnel

(intercom, phone, fax, and computer):  Yes  No

68. All drains in the cabinet room(s), inner change room(s), and autoclave chambers connect

directly to an appropriate liquid waste decontamination system:  Yes  No

If yes, describe method utilized for decontamination of BSL-4 area(s):

__________________________________________________________________________________________

__________________________________________________________________________________________

69. Will work be performed in a protective suit:  Yes  No

1. A breathing air system is provided with redundant compressors, backup storage tanks,

HEPA filtration protection, and alarm monitoring in the event of failure:  Yes  No

2. All penetrations into containment shell (walls, floors, and ceilings) of the suit area(s),

chemical shower(s), and airlock(s) are sealed:  Yes  No

3. Daily inspections of the containment parameters and life support systems are performed,

completed and documented before laboratory work begins:  Yes  No

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

filtration:  Yes  No

5. Liquid and gas services to the suit area(s) are protected by backflow devices:  Yes  No

70. Will work with animals be performed in ABSL-4 laboratory:  Yes  No

a. Specific procedures have been developed for handling animals under ABSL-4 conditions in the

Class III cabinet or protective suit laboratories:  Yes  No

2. Aerosol experiments are conducted in this ABSL-4 laboratory:  Yes  No

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

____________________________________________________________________________________

­____________________________________________________________________________________

d. Personnel assigned to work with infected animals work in pairs:  Yes  No

III. APHIS/CDC Form 2 “Request to Transfer Select Agents and Toxins”

1. For the instructions section in the guidance document on page 1 revised to:

1. “Prior to transferring a select agent or toxin, the recipient RO must complete section 1, sign and date at the bottom of the page, and send the completed form to APHIS or CDC for transfer approval. For registered entities, the information provided for this form must match the information submitted in the entity’s certificate of registration.

   1. Transfer of select agents or toxins may require the intended recipient to obtain a valid USDA and/or PHS permit prior to the transfer (See 7 CFR Part 330.200, 9 CFR Part 122.2, and 42 CFR Part 71.54) The application and instructions for obtaining USDA transport or import permits are available through the APHIS website at: http://www.aphis.usda.gov/vs/ncie/ or the PPQ website at: http://www.aphis.usda.gov/ppq/permits/ or by calling 301-734-5960. The application and instructions for obtaining PHS import permits are available through the CDC website at: http://www.cdc.gov/od/eaipp/ or by calling 404-718-2077. A copy of the APHIS and/or PHS permit should be included with the transfer request.

   2. Clinical and diagnostic laboratories that transfer select agents and toxins after identification (See 7 CFR 331, 9 CFR 121, and 42 CFR 73) are required to submit this form for approval prior to transferring the select agent or toxin for research purposes to a registered entity (see also APHIS/CDC Form 4, “Report of the Identification of a Select Agent or Toxin”).

   3. The agency receiving the form (APHIS or CDC) will review the request and approve or disapprove the transfer. The agency will return the form to the recipient RO and will send a copy of the form to the sender. The transfer must be completed within 30 days of issuance of the Transfer Authorization.

2. When the sender receives the Form 2 with CDC or APHIS authorization for transfer, the sender must complete Section 2 and sign and date at the bottom of Section 2.

   1. For block 25 (“Characterization of agent”), please provide characterization of agent (e.g., strain designation, GenBank Accession number, publication citation, molecular characterization data, etc.). If unknown, indicate “not known” for block.

   2. For block 36 (“Name of carrier”), please indicate the method of shipment (e.g., Fed-Ex delivery or hand-delivered by sender, recipient, or federal law enforcement agency. For hand-deliveries, please include the name of the individual).

   3. If the sender has a suspicion that the agent may not be used for the requested purpose, then the sender should consult with APHIS or CDC prior to the transfer. Select agents and toxins must be packaged, labeled, and shipped in accordance with all federal and international regulations. It is highly recommended that the sender utilize a method for tracking the movement of the select agents and toxins being shipped.

   4. The sender must place one copy of page 2 of the Form in the shipment and send one copy of page 2 of the form to CDC or APHIS.

      3. Upon receipt of the shipment, the recipient’s RO must complete Section 3 and send one copy of page 2 of the form to the sender and one copy to APHIS or CDC within 2 business days of receipt. If the select agent or toxin has not been received within 48 hours after the expected delivery time or the package received containing select agents or toxins has been damaged to the extent that a release of the select agent or toxin may have occurred, the recipient’s RO must immediately report to APHIS or CDC and complete APHIS/CDC Form 3, “Report of Theft, Loss, or Release of Select Agents and Toxins.” A copy of the completed form must be maintained for 3 years. NOTE: If the transfer does not occur within 30 days of authorization, the recipient RO completes block 39 of Section 3 and sends the completed form to APHIS or CDC.”

B. For the form,

1. Separated the form into 3 different sections. Section 1 is to be completed by the recipient to request the transfer. Section 2 is to be completed by the sender to report the sending of the package. Section 3 is to be completed by the recipient to report the receipt of the select agent or toxin.

2. Removed APHIS/CDC Authorization Information block from page 2 of form.

3. “Section 1” of the form located on page 2 was revised to:

SECTION 1 – TO BE COMPLETED BY RECIPIENT
SECTION A – RECIPIENT INFORMATION
1. Entity name:		2. Entity registration number:
3. Address (NOT a post office address):		4. City:		5. State:	6. Zip Code:
7. Principal Investigator name First: MI: Last:		8. a. APHIS Permit #: b. US PHS#:
9. Responsible Official name First: MI: Last:		10. Telephone #:
11. FAX #:		12. E-mail address:
SECTION B – SENDER INFORMATION
13. Entity name:		14. Entity registration number: ______________________________ Clinical/diagnostic laboratory Other: _______________________________________
15. Address (NOT a post office address):		16. City:	17. State:		18. Zip Code:
19. Responsible Official (RO) or facility director First: MI: Last:		20. Telephone #:
21. FAX #:		22. E-mail address:
SECTION C – LIST OF SELECT AGENTS AND TOXINS REQUESTED (attach additional sheets if necessary)
23. Select agents and/or toxins to be transferred:
A
B
C
D
E
F

I hereby certify that the information contained in Section 1 on this form is true and correct to the best of my knowledge. I understand that if I knowingly provide a false statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that violations of 7 CFR 331, 9 CFR 121, and 42 CFR 73 may result in civil or criminal penalties, including imprisonment.

Signature of Responsible Official: _________________________________________________ Title: ____________________________________

Typed or printed name of Responsible Official: _______________________________________ Date: _________________________________

4. Added to the top of page 3 of form: Read all instructions carefully before completing the report. This report must be signed and submitted to either APHIS or CDC:

Animal and Plant Health Inspection Service Centers for Disease Control and Prevention

Agricultural Select Agent Program Division of Select Agents and Toxins

4700 River Road Unit 2, Mailstop 22, Cubicle 1A07 1600 Clifton Road NE, Mailstop A-46

Riverdale, MD 20737 Atlanta, GA 30333

FAX: 301-734-3652 FAX: 404-718-2096

APHIS/CDC AUTHORIZATION NUMBER: ___________________ EXPIRATION DATE: ______________

5. “Section 2” of the form located on page 3 was revised to:

SECTION 2 – TO BE COMPLETED BY SENDER
SECTION A – LIST OF SELECT AGENTS AND TOXINS SHIPPED (attach additional sheets if necessary)
	24. Select agents and/or toxins:	25. Characterization of agent:				26. Number of vials:		27. Form (powder/liquid/ slant):		28. Volume or weight of vial contents (e.g., mL, mg, ng):
A
B
C
D
SECTION B – SHIPPING INFORMATION
29. Recipient Notified of Expected Shipment Date: First: MI: Last:			30. Date of notification:				31. Type of notification:  E-mail  Fax  Telephone
32. Name of individual who packaged shipment: First: MI: Last:				33. Number of packages shipped:					34. Shipment Date:
35. Package description (size, shape, description of packaging including number and type of inner packages):
36. Name of carrier (If hand-delivered, please indicate and include name of individual:					37. Airway bill number/bill of lading number/tracking number:

I hereby certify that the select agents and/or toxins were packaged, labeled, and shipped in accordance with all federal and international regulations and information contained on in Section 2 of this form is true and correct to the best of my knowledge. I understand that if I knowingly provide a false statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that violations of 7 CFR 331, 9 CFR 121, and 42 CFR 73 may result in civil or criminal penalties, including imprisonment.

Signature of Sender: _________________________________________________ Title: ____________________________________

Typed or printed name of Sender: _______________________________________ Date: ____________________________________

6. “Section 3” of the form located on page 3 was revised to:

SECTION 3 – TO BE COMPLETED BY RECIPIENT
38. Name of individual who received shipment: First: MI: Last:	39.  Transfer Did Not Occur  Transfer Occurred/Date of Receipt:
40. The agents/toxins listed in Section was received:  Yes  If no, explain discrepancy in separate attachment.	41. Shipment was packaged, labeled, and shipped in accordance with regulations:  Yes  If no, explain discrepancy in separate attachment.

I hereby certify that the information contained in Section 3 on this form is true and correct to the best of my knowledge. I understand that if I knowingly provide a false statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that violations of 7 CFR 331, 9 CFR 121, and 42 CFR 73 may result in civil or criminal penalties, including imprisonment.

Signature of Responsible Official: _______________________________ Title: ___________________________________

Typed or printed name of Responsible Official: ___________________________ Date: ________________________________

IV. APHIS/CDC Form 3 “Report of Theft, Loss, or Release Select Agents and Toxins”

1. In block #19 of the form on page 2, added “theft/release” to the statement.

2. Removed blocks #33 and #34 of the form on page 2 and renumbered blocks to coordinate the change.

3. Revised block #37 of the form on page 2 which is now block #33 to read “Provide a detailed summary of events including a timeline of events and name and telephone numbers of agencies notified. The summary should also include description of containers (e.g., size, color, type, brand, and any symbols or markings), supporting documentation (e.g., access and inventory records), identified weaknesses, and any corrective actions taken (attach additional sheets if necessary):”

4. Revised Section 3 of the form on page 3 to:

SECTION 3 – IF THE INCIDENT OCCURRED DURING TRANSFER PROVIDE THE FOLLOWING INFORMATION AND INCLUDE A COPY OF THE RELEVANT APHIS/CDC FORM 2
33. Transfer authorization number from APHIS/CDC Form 2:		34. Date shipped:
35. Name of carrier:		36. Airway bill number/bill of lading number/tracking number:
37. Package description (size, shape, description of packaging including number and type of inner packages; attach additional sheets if necessary):
38. Package with select agents and toxins received by requestor:  No  Yes If yes, date of receipt:	39. Package with select agents and toxins appears to have been opened:  No  Yes (If Yes, include in explanation above for Box #37)
40. Sender was contacted regarding incident:  No  Yes	41. Carrier/courier was contacted regarding incident:  No  Yes

V. APHIS/CDC Form 4 “Reporting the Identification of a Select Agent or Toxin in a Clinical or Diagnostic Laboratory”

A. In the introduction paragraph, revised the 2^nd and 3^rd paragraph on page 1 to read “Clinical or diagnostic laboratories and other entities that have identified select agents and toxins contained in a specimen presented for diagnosis, verification, or proficiency testing are required by regulation (7 CFR 331, 9 CFR 121, and 42 CFR 73) within 7 calendar days after identification of the select agent or toxin contained in a specimen presented for diagnosis or verification or within 90 days of receipt for proficiency testing must report this identification to APHIS or CDC. In addition to the reporting requirement, the identified select agent or toxin must be secured against theft, loss, or release during the period between identification and final disposition. Within 7 calendar days after identification of the select agent or toxin contained in a specimen presented for diagnosis or verification or 90 days of receipt for proficiency testing, the identified select agent or toxin must be transferred in accordance with 7 CFR 331.16, 9 CFR 121.16 or 42 CFR 73.16 or destroyed on-site by a recognized sterilization or inactivation process. The select agent or toxin may be retained only if the entity is currently registered for the select agent and toxin identified. If the select agent or toxin is retained, the entity may need to amend its certificate of registration to reflect the addition of the agent and maintain records associated with any intra-entity transfers. To report the identification of a select agent, the Responsible Official or Facility Director must submit this form (APHIS/CDC Form 4) to either APHIS or CDC:

Animal and Plant Health Inspection Service Centers for Disease Control and Prevention

Agricultural Select Agent Program Division of Select Agents and Toxins

4700 River Road Unit 2, Mailstop 22, Cubicle 1A07 1600 Clifton Road NE, Mailstop A-46

Riverdale, MD 20737 Atlanta, GA 30333

FAX: 301-734-3652 FAX: 404-718-2096

E-mail: [email protected] Email: [email protected]

The following select agents and toxins contained in a specimen presented for diagnosis or verification are required to be immediately reported to APHIS or CDC:

African horse sickness virus Nipah virus

African swine fever virus Peronosclerospora philippinensis

Avian influenza virus (highly pathogenic) Ralstonia solanacearum race 3, biovar 2

Bacillus anthracis Rift Valley fever virus

Botulinum neurotoxins Rinderpest virus

Bovine spongiform encephalopathy agent Schlerophthora rayssiae var zeae

Brucella melitensis South American Hemorrhagic Fever viruses (Junin, Machupo,

Candidatus Liberobacter africanus Sabia, Flexal, Guanarito)

Candidatus Liberobacter asiaticus Swine vesicular disease virus

Classical swine fever virus Synchytrium endobioticum

Foot‑and‑Mouth disease virus Variola major virus (Smallpox virus)

Francisella tularensis Variola minor (Alastrim)

Ebola virus Venezuelan equine encephalitis virus

Hendra virus Xanthomonas oryzae pv. Oryzicola

Lassa fever virus Xylella fastidiosa (citrus variegated chlorosis strain)

Marburg virus Yersinia pestis

Newcastle disease virus (velogenic)”

B. In the Instructions Section on page 1, revised #1 and #2 to read “The reference laboratory (laboratory that confirms the identification of the select agent) completes Section 1 within seven calendar days after identification for all entities in possession of the specimen or isolate at the time of the identification. Additional copies of Section C are available at http://www.selectagents.gov, http://www.aphis.usda.gov/programs/ag_selectagent/index.html and http://www.cdc.gov/od/sap.

1. For registered entities, the information provided for this form should match the information submitted for the entity’s certificate of registration (blocks 1-10).

2. Please provide all information as it relates to the case. For example, the case (e.g., patient) generates multiple specimens (e.g., tissue, fluid) that is plated on different media (e.g., 15 blood agar plates), you would list all this information as 1 case for block 15. Attach additional sheets if necessary.

1. To request prior authorization to transfer select agent(s) or toxin(s) identified for research purposes, APHIS/CDC Form 2, “Request to Transfer Select Agents and Toxins,” must be submitted to either APHIS or CDC. To ensure that your entity receives authorization from APHIS or CDC to transfer the select agent or toxin, you need to verify that the recipient is registered for that agent.“

C. In the instruction section in the guidance document on pages 1 and 2, revised to the instruction to incorporate the 3 sections created for the different reports.

D. For #2 under “Proficiency testing” section on page 2, revised #2 to read “To request prior authorization to transfer select agent(s) or toxin(s) identified, APHIS/CDC Form 2, “Request to Transfer Select Agents and Toxins,” must be submitted to either APHIS or CDC. To ensure that your entity receives authorization from APHIS or CDC to transfer the select agent or toxin, you need to verify that the recipient is registered for that agent.”

E. Revised “Reporting seized select agents or toxins by federal law enforcement agencies” section on page 2 to read: “1. Complete section 3 within seven calendar days after seizure and/or final disposition of select agents or toxins.

2. For registered entities, the information provided for this form should match the information submitted for the entity’s certificate of registration (blocks 57-66).”

F. For the form,

1. Separated the 3 reports into 3 different sections. Section 1 is to report the select agent or toxin identified in diagnostic or clinical samples. Section 2 is to report the select agent or toxin identified in proficiency samples. Section 3 is to report the seizure of select agent or toxin by federal law enforcement agency.

2. Revised Section 1 to:

SECTION 1 – TO BE COMPLETED BY REFERENCE LABORATORY
SECTION A – REFERENCE LABORATORY INFORMATION
1. Entity name:		2. Entity registration number: _______________________  Clinical/diagnostic laboratory
3. Address (NOT a post office address):		4. City:	5. State:	6. Zip Code:
7. Responsible Official or Facility Director name First: MI: Last:		8. Telephone #:
9. FAX #:		10. E-mail address:
SECTION B – SELECT AGENTS AND TOXINS IDENTIFIED FROM CLINICAL/DIAGNOSTIC SPECIMENS
11. Select agent or toxin being reported:	12. Date(s) agent was identified:
13. Type of sample analyzed:  Clinical/diagnostic sample  Environmental sample  Isolate  Other (specify): ______________________
14. Original source of sample:  Human  Animal (species: _________________________________________________)  Plant (species: ___________________________________)  Other (specify): ____________________________________
15. Provide a summary of the methodologies used to identify the select agent or toxin including specimen type(s), media, total quantity, and if the source expected to provide additional specimens (see instructions):
16. Was there a possibility that personnel in your laboratory were exposed to the select agent or toxin while working with this sample?  No  Yes (If Yes, please complete APHIS/CDC Form 3.)
17. Disposition of select agent or toxin: Transferred to a registered entity (Give entity name and APHIS/CDC registration number. Include a copy of the approved APHIS/CDC Form 2, “Request to Transfer Select Agents and Toxins”):____________________________________________________________________________  Destroyed on site:  Autoclaving  Chemical (Describe:_________________)  Incineration  Irradiation  Other:______________ Date select agent or toxin was destroyed: ____________ Retained and transferred via intra-entity transfer to (Give name of Principal Investigator and/or Amendment #): ___________________________ Date select agent or toxin was transferred: ____________
SECTION C – SAMPLE PROVIDER
18. Has the sender(s) of the sample been notified of the identification of the select agent or toxin?  No  Yes NOTE: Please complete Section C for each laboratory that was in possession of the sample or isolate. (Attach additional sheets if necessary.)
19. Entity name:	20. Entity registration number: _______________________  Clinical/diagnostic laboratory
21. Address (NOT a post office address):	22. City:		23. State:	24. Zip Code:
25. Responsible Official (RO) or facility director First: MI: Last:	26. Telephone #:
27. FAX #:	28. E-mail address:
29. Was there a possibility of an exposure while working with this sample?  No  Yes (If Yes, please complete APHIS/CDC Form 3.)
30. Disposition of select agent or toxin:  Destroyed on site Retained  Transferred to a registered entity (Provide entity name if different than Block 1): _______________________________________

I hereby certify that the information contained on this form is true and correct to the best of my knowledge. I understand that if I knowingly provide a false statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that violations of 7 CFR 331, 9 CFR 121, or 42 CFR 73 may result in civil or criminal penalties, including imprisonment.

Signature of Responsible Official/Facility Director: _______________________________________________ Date: _______________________

3. Revised Section 2 to:

SECTION 2 – TO BE COMPLETED BY LABORATORY THAT RECEIVED PROFICIENCY TESTING
SECTION A – LABORATORY INFORMATION
31. Entity name:		32. Entity registration number:
33. Address (NOT a post office address):		34. City:	35. State:	36. Zip Code:
37. Responsible Official or Facility Director name First: MI: Last:		38. Telephone #:
39. FAX #:		40. E-mail address:
41. Was there a possibility of an exposure while working with this sample?  No  Yes (If Yes, please complete APHIS/CDC Form 3.)
SECTION B – SELECT AGENTS AND TOXINS IDENTIFIED FROM PROFICIENCY TESTING
42. Select agent and strain designation (if known) or toxin being reported:	43. Total quantity identified:
44. Location where proficiency testing was conducted Building: Room:	45. BSL of laboratory or PPQ containment designation:
46. Name of laboratory test that proficiency test was designed to assess:	47. Date obtained from sponsor:
48. Sponsor/entity that you received select agent or toxin from:  College of American Pathologists  Registered entity (Entity name, APHIS or CDC registration number):________________________________________________________________  Other (Explain):
49. Disposition of select agent or toxin: Transferred to a registered entity (Give entity name and APHIS/CDC registration number. Include a copy of the approved APHIS/CDC Form 2, “Request to Transfer Select Agents and Toxins”):____________________________________________________________________________  Destroyed on site:  Autoclaving  Chemical (Describe:_________________)  Incineration  Irradiation  Other:______________ Date select agent or toxin was destroyed: ____________ Retained and transferred via intra-entity transfer to (Give name of Principal Investigator and/or Amendment #): ___________________________ Date select agent or toxin was transferred: ____________

I hereby certify that the information contained on this form is true and correct to the best of my knowledge. I understand that if I knowingly provide a false statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that violations of 7 CFR 331, 9 CFR 121, or 42 CFR 73 may result in civil or criminal penalties, including imprisonment.

Signature of Responsible Official/Facility Director: ___________________________________________ Date: ___________________________

4. Revised Section 3 to:

SECTION 3 – TO BE COMPLETED BY FEDERAL LAW ENFORCEMENT AGENCY
SECTION A – FEDERAL LAW ENFORCEMENT INFORMATION
50. Name of federal law enforcement agent First: MI: Last:	51. Telephone #:
52. Badge #:	53. E-mail address:
54. Select agent and strain designation (if known) or toxin being seized:	55. Total quantity identified:
SECTION B – ENTITY INFORMATION
56. Disposition of select agent or toxin: Transferred to a registered entity (Give entity name and APHIS/CDC registration number.):_______________________________________________  Destroyed on site:  Autoclaving  Chemical (Describe:_________________)  Incineration  Irradiation  Other:______________ Date select agent or toxin was destroyed: ____________
57. Entity name:	58. Entity registration number:
59. Address (NOT a post office address):	60. City:	61. State:	62. Zip Code:
63. Responsible Official name First: MI: Last:	64. Telephone #:
65. FAX #:	66. E-mail address:
67. Select agent and strain designation (if known) or toxin being seized:	68. Total quantity identified:

I hereby certify that the information contained on this form is true and correct to the best of my knowledge. I understand that if I knowingly provide a false statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that violations of 7 CFR 331, 9 CFR 121, or 42 CFR 73 may result in civil or criminal penalties, including imprisonment.

Signature of Agent: ______________________________________________________ Date: _________________________

VI. APHIS/CDC Form 5 “Request for Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational Product”

A. In purpose section in the guidance document on page 1, revised to read “The purpose of this form is to request exemptions:

1. For exemption requests that involve the investigational product that is, bears, or contains select agents or toxins, APHIS or CDC will confirm that the Food and Drug Administration (FDA) has accepted or approved, under the authority of the Food, Drug, and Cosmetics Act (21 U.S.C. 301 et. seq.), an Investigational New Drug application (IND), Investigational New Animal Drug (INAD) application or an Investigational Device Exemption (IDE) application for a clinical trial involving the use of an investigational product that is, bears, or contains a select agent or toxin.

2. For the response to an extraordinary public health or agricultural emergency(ies).”

B. In the instruction section in the guidance document on page 1, revised to the instruction to incorporate the 2 sections created for the different exemption requests.

C. For the form,

1. Changed Section 1 header on page 2 to “TO BE COMPLETED FOR INVESTIGATIONAL PRODUCT EXEMPTION” and deleted Section 2 header for the table on page 2.

2. Separated the 2 exemptions into 2 different sections. Section 1 is to submit a request that involve the investigational product that is, bears, or contains select agents or toxins. Section 2 is to submit a request to respond to an extraordinary public health or agricultural emergency.

3. For Section 1 on page 2, added “IDE” to the block that contained “FDA/IND/INAD number.”

4. For Section 1 on page 2, added a block that stated “16. Date of the IND/INAD/IDE application submitted to FDA including the name of the FDA center and review office

FDA Center/Review Office: Date:”

5. Added a certification statement and signature line to page 2 that states “I hereby certify that the information contained on this form is true and correct to the best of my knowledge. I understand that if I knowingly provide a false statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that violations of 7 CFR 331, 9 CFR 121, or 42 CFR 73 may result in civil or criminal penalties, including imprisonment. For exemption requests that involve the investigational product that is, bears, or contains select agents or toxin, I authorize FDA to confirm for APHIS or CDC the existence and status of the IND, INAD, or IDE, and agree that such confirmation will not violate FDA's information disclosure regulations, the Federal Food, Drug, and Cosmetic Act, or the Trade Secrets Act (18 U.S.C. § 1905).

Signature of Investigational Product Exemption Applicant: _________________________________________ Date: ________________”

6. Added address header blocks to revised Section 2 on page 3 which replaced Section 3:

23. Entity name:			24. Entity registration number (if applicable):
25. Entity address (NOT a post office address):		26. City:			27. State:	28. Zip code:
29. Applicant First: MI: Last:				30. Title:
31. Telephone #:	32. FAX #:			33. Email address:
34. Are you the:  Facility Director  Responsible Official  Other (specify):

7. Deleted at the bottom of page 3 “Signature of Emergency Exemption Applicant: __________________________________________________ Date: _____________________”