FAQ: Compliance APHIS/CDC Form 1

An individual or entity that intends to possess, use, or transfer any select agent or toxin, including receipt of select agents and toxins from outside the United States, must register with either Department of Health and Human Services (HHS)/Centers for Disease Control and Prevention (CDC)/Division of Regulatory Science and Compliance (DRSC) or U.S. Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS)/ Division of Agricultural Select Agents and Toxins (DASAT) (collectively known as the Federal Select Agent Program). Specific exemptions for clinical or diagnostic laboratories and federally authorized products that may apply in certain situations are found in sections 5 and 6 of the regulations (42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121). Sections 3 and 4 of the regulations also establish criteria for when agents or toxins are excluded from the requirements of the select agent regulations.

The current Select Agent Regulations can be found here.

A complete APHIS/CDC Form 1 – Application for Registration for Possession, Use and Transfer of Select Agents and Toxins must be submitted to the Federal Select Agent Program for review. The APHIS/CDC Form 1 and instructions for completing the application can be found here.

Questions on how to fill out the application can be sent to lrsat@cdc.gov or DASAT@usda.gov.

The certificate of registration is the document issued by the Federal Select Agent Program that denotes approval for the select agents and/or toxins that an individual or entity is authorized to possess, use and/or transfer; the specific activities related to the registered select agents and/or toxins; persons authorized to access the select agents and/or toxins; and the locations (buildings, group of buildings, rooms, storage facilities, etc.) where select agents and/or toxins are authorized to be present as described in the entity’s APHIS/CDC Form 1. The certificate of registration is required to be amended prior to making any changes and must be reauthorized at least every three years from the date it was initially issued or renewed.

No. You may submit your application for registration to DRSC or DASAT. DRSC and DASAT work together to provide a single point of contact. This single point of contact is referred to as the “lead agency”, and as such, is responsible for coordinating all activities and communications with respect to your registration, including coordination with the non-lead agency.

To apply for a certificate of registration that lists only “HHS select agents and toxins” (see 42 CFR 73.3), an individual or entity must submit the completed APHIS/CDC Form 1 to DRSC.

To apply for a certificate of registration that lists only “USDA Veterinary Services (VS) select agents and toxins” and/or “USDA Plant Protection and Quarantine (PPQ) select agents and toxins” (see 9 CFR § 121.3, 7 CFR § 331.3), an individual or entity must submit the completed APHIS/CDC Form 1 to DASAT.

To apply for a certificate of registration that lists any combination of “HHS select agents and toxins,” “USDA VS select agents and toxins,” “USDA PPQ select agents and toxins,” and “Overlap select agents and toxins” (see 42 CFR § 73.4 and 9 CFR § 121.4), an individual or entity may submit the completed APHIS/CDC Form 1 to either DRSC or DASAT, but not both.

If you have questions while completing the application, you can send the questions to lrsat@cdc.gov or DASAT@usda.gov. A listing of HHS and USDA select biological agents and toxins is available here.

It depends on the scope and complexity of the registration application. Each application is thoroughly reviewed by Federal Select Agent Program. An inspection of your entity may be required prior to approval.

A designated DRSC or DASAT representative will be assigned to your entity once the Federal Select Agent Program has completed an initial review of your application. The name and contact information for your designated representative will be communicated to your RO designee. Any requests regarding your application should be communicated to your designated representative.

Prior to any change (e.g., personnel, space, work, animal species or agents), the RO must apply for an amendment to the entity’s certificate of registration. The amendment must be approved before the requested changes can be implemented.

Instructions for completing an amendment can be found here.

The RO may request a change to the registration. Further information can be found in the RO Guidance Document [PDF – 1 MB]. The RO must retain oversight of the decisions that would necessitate changes to the registration and submission of documents to the Federal Select Agent Program, but the Alternate Responsible Official (ARO) can sign and submit forms and information in support of those decisions.

Response: Not in all cases.

The shipping and receiving area would need to be listed on the entity’s certificate of registration if the packages are labeled as containing select agent material and temporarily stored in the shipping and receiving area prior to being transported. However, if packages are only labeled as containing “Category A infectious substances” and temporarily stored in the shipping/receiving area, then there would be no need to register that area as the “lost in the crowd” concept is still employed.

The entity’s security plan must contain procedures describing how the entity ships and receives select agents and toxins. The procedures should contain documented processes to ensure select agents and toxins are safeguarded against theft, loss, intentional release or unauthorized access when a select agent or toxin is: (1) ready to be packaged for transportation, (2) packaged for shipment, or (3) received by a person with approval to access select agents and toxins. The procedures should include:

• How the transfer is coordinated between the shipper and intended recipient;
• How the package will be tracked in transit to ensure that the intended recipient is aware of the package’s expected arrival;
• How the package arrives to the intended recipient; and
• How the entity handles unexpected shipments.

Yes, the shipping and receiving area must be listed on the entity’s certificate of registration since packaging of select agents and toxins will occur here. The shipping and receiving area must meet all the requirements outlined in the select agent regulations as for other registered areas listed on the entity’s certificate of registration. If Tier 1 select agents and toxins will be packaged in the shipping and receiving area, it must meet all provisions associated with Tier 1 requirements. All individuals who will have access to Tier 1 select agents or toxins must also meet Tier 1 requirements and be enrolled in the entity’s suitability assessment program. The area will also be inspected to ensure the entity’s compliance with the select agent regulations.

The entity abstract must be completed when an entity submits a new application, when an entity submits the complete APHIS/CDC Form 1 for registration renewal, or at any time the information in this section changes. Please refer to Section 1C – Entity Abstract in the Form 1 Instructions document for additional information related to this section.

The entity’s registration should only list those rooms where select agents or toxins are used and/or stored. Nevertheless, it should be noted that any records or information systems that could allow an individual to gain access to the select agents or toxins should be safeguarded to prevent unauthorized access, theft, loss, or release of these materials, even if they are located in non-registered spaces.

No, an entity would only need to include rooms where select agents/toxins are used or stored. However, if an entity uses or stores select agents or toxins at differing physical addresses, e.g., a laboratory located on a different campus of academic institution or a satellite facility, then the different addresses must be included in the Section 1. Please refer to the Form 1 Instructions document here for additional information.

Section 3 should include all select agents and toxins that the entity possesses or wishes to possess for the entity as a whole.

No, there is no “N/A” option on the current APHIS/CDC Form 1. If the question does not apply to the entity, “no” should be checked.

No, in cases when the individual visiting the registered space is not able to access the select agent or toxin and the individual is escorted by a person with a security risk assessment.

Yes, in cases when the individual visiting the registered space is able to access the select agent or toxin. In these cases the individual would need to undergo a security risk assessment and be listed on Section 4B – Support Staff. Please refer to Section 4B – Support Staff in the Form 1 Instructions document for additional information.

In cases when an individual who has already obtained select agent access by the Federal Select Agent Program following an FBI security risk assessment is temporarily visiting a different registered institution (i.e., visiting scientist or individual who will receive training), the individual would need to have a security risk assessment with the home entity (i.e., individual’s place of employment) and be listed on the host entity’s Section 4C – Unescorted Visitors. Please refer to Section 4C – Unescorted Visitors in the Form 1 Instructions document for additional information.

No, a supervising PI does not need to be listed for support staff. Please refer to Section 4B – Support Staff in the Form 1 Instructions document for additional information.

Yes, if an individual is supervised by more than one PI, list each PI in the Supervising PI column. If the person will work with all PIs, the term “All PIs” may be listed in the Supervising PI column. Please refer to Section 4A – Laboratorians and Animal Care Staff in the Form 1 Instructions document for additional information.

It depends on the circumstances. The entity needs to determine if the individual will have access to or the ability to gain access to a select agent or toxin.  An individual will be deemed as having access at any point in time if the individual has possession of (e.g., ability to carry, use, or manipulate) or the ability to gain possession of a select agent or toxin. If an individual has access to select agents or toxins but does not work with the agents, the individual(s) should still be listed as support staff and the most appropriate role on section 4B.

If the individual will not have access to a select agent or toxin, the individual does not need to be included on your Section 4 of APHIS/CDC Form 1.

An individual who performs any of the work listed in the entity’s work objectives and manipulates select agents or toxins should be listed as a laboratorian in Section 4A. Any individual who handles select agent infected animals, plant hosts or their hazardous waste that includes select agents (e.g., animal bedding) should be listed as animal care staff in Section 4A. Please refer to Section 4A – Laboratorians and Animal Care Staff in the Form 1 Instructions document for additional information.

For agents that have been genetically modified due to passage in vivo or in vitro and have become differentiated from the parental organism, the modified agent or toxin should be recorded as a separate strain on the strain table (examples may include: extended in vitro passage under increasing concentrations of one or more antimicrobials in order to generate a desired enhanced resistance profile; in vivo passage of an attenuated strain to select for the restoration of virulence. Please refer to Section 7B – Strain or Serotype Designations Information in the Form 1 Instructions document for additional information.

Note: An Excel version of Section 7B (here) is available to copy and paste strain information into the spreadsheet.

If the entity changes possession status of a select agent or toxin, the checkbox located in Section 3 must be unchecked/checked. Section 3 only needs to be updated if there is a change in the possession status or another change that requires submission of Section 3. Please refer to Section 3 – Select Agents and Toxins in the Form 1 Instructions document for additional information.

The individual who is the custodian or guardian of the inventory (not the individual(s) who audits the inventory) and who is responsible for maintaining a current and accurate inventory record. This individual may be the PI or another designee.

No, as long as the entity meets the exemption outlined under 42 CFR 73.6 and the principal investigator  will not possess above the aggregate amount of toxin (see 42 CFR 73.3 for these amounts). Any principal investigator who will possess above the aggregate amount of select toxin or a principal investigator, who chooses to be registered for select toxins regardless of the aggregate amount, is required to be registered for select toxin and will need to complete Attachment A. Please refer to Report of Identification of Select Agent or Toxin FAQs regarding questions involving the identification of a select agent or toxins during diagnosis, verification, or proficiency testing.

For Section 6B, you would select BSL-3 and/or ABSL-3 as appropriate and indicate any enhancements by answering the questions listed in Section 6B.

No, you will need to provide strain and serotype information in Section 7B. Note: You may submit the Excel version of Section 7B will allow you to copy and paste strain information. Please refer to Section 7B – Strain or Serotype Designation Information in the Form 1 Instructions document for additional information.

Yes, any update (i.e., change in demographic information, addition/removal personnel, agents, space, etc.) to the APHIS/CDC Form 1 is considered an amendment and is processed as such by the Federal Select Agent Program. An amendment is considered pending until final approval is communicated to the entity by the Federal Select Agent Program. Approval of adding a new employee is required before implementing the changes requested in the amendment. Please refer to Amendment Requirements in the Form 1 Instructions document.

The entity must submit a cover letter signed by the RO or ARO to their Federal Select Agent Program file manager that details the requested changes to the registration.  In addition, the appropriate section(s) of the APHIS/CDC Form 1 must be submitted, reflecting the change(s) to the registration. For guidance on amendment cover letters, please reference the Amendment Requirements section of the Form 1 Instructions document. For guidance on the submitting the appropriate sections of the Form 1, please see the Amendment Reference Table and use the links within for detailed information.

No, only a letter is required to remove an individual from Sections 4A, 4B or 4C.  To remove personnel from Sections 4A, 4B or 4C, submit a cover letter stating the name of the individual to be removed and the reason for removal. If the individual is the custodian for a PI’s inventory, an updated Section 7C will need to be submitted listing the individual(s) who will now be responsible for this inventory.  Please refer to the Personnel Amendments section of the Form 1 Instructions document for additional information.

Approximately 60 days prior to an entity’s registration expiration date, the Responsible Official (RO) must submit a Request for Registration Renewal amendment and sign the Section 2 of the APHIS/CDC Form 1.  While your FSAP Point of Contact (POC) may contact you before the 60 days prior to the registration expiration date and advise you that you need to submit a Registration Renewal amendment, it is the RO’s responsibility to monitor the expiration date and submit the amendment in a timely manner.
To submit a registration renewal amendment:

1. Log into eFSAP.
2. Click on Form 1. Select the action Amend.
3. Select Request Registration Renewal from the dropdown menu.
4. Provide a statement of the renewal request in the cover letter section.
   1. Example: “We are requesting a three-year renewal of registration for [Entity Name].”
5. Click Submit.

The FSAP POC will review the request, verify the information is current and accurate, and contact you if additional information is necessary. If everything is in order, FSAP will approve the amendment prior to the current expiration date. FSAP will upload your registration renewal letter and registration certificate to eFSAP.

An RO must sign the Section 2 of the APHIS/CDC Form 1 as prompted to certify that the requirements of the select agent regulations have been met. The Section 2 must be signed before a three-year Renewal of Registration will be approved. Additionally, if a new RO is appointed, he or she must sign the Section 2 of the APHIS/CDC Form 1.

If you receive a request for information in eFSAP or by email, you do not need to submit a new amendment. You can reply to your entity POC using the General Discussion Boards within eFSAP.

1. Click on the link to the Request for Information in your notifications and use the General Discussion on the Amendment page or applicable section of the Form 2, 3, 4 page to respond to the request.
2. In response to a Request for Information not connected to an amendment or APHIS/CDC Form 2, 3, 4 (e.g., Science Office, inspection response) go to the eFSAP homepage to upload supporting documentation.

To upload supporting documentation, see the “How do I upload supporting documentation for an amendment?” FAQ.

1. Log into eFSAP.
2. Click on Form 1. Select the action Amend.
3. Select All Other Amendments from the dropdown menu.
4. Submit an e-cover letter and upload supporting documentation for whatever change is necessary. For more instructions, please see the APHIS/CDC Form 1 Resources.

The RO or ARO who is acting on behalf of the RO can only submit amendments to their registration.  To submit an amendment, an RO (or ARO in the absence of the RO) needs an active SAMS account to access eFSAP.

Log into eFSAP. Click on Form 1 and select the action Amend. Next, select the type of amendment that you would like to perform – Self-Service or Other.
Self-service amendments that do not require approval include:

• Section 1 – Change Entity Name, Abstract, or Type
• Section 2 – Sign Section 2
• Section 4 – Add/Remove/Modify/Reactivate Personnel
• Section 7B – Add/Remove/Modify Strains and Serotypes

For these amendments, simply update the information, and save.
Amendments that still require a brief digital cover letter for review and approval by FSAP include:

• Section 1 – Change Entity Physical Address
• Section 5A – Modify Entity-Wide Security Assessment and Incident Response
• Section 5B – Modify Entity-Wide Biosafety/Biocontainment
• Section 5C – Modify Entry Requirements for Federal Select Agent Program Inspectors
• Request Registration Renewal
• All Other Amendments

These above listed amendments will require you to provide a description of the requested change in the Cover Letter box and provide documentation as requested.

You may click the Edit button to make changes to a draft or pending amendment.

The RO or ARO who is acting on behalf of the RO can only submit amendments to their registration.  To submit an amendment, an RO (or ARO in the absence of the RO) needs an active SAMS account to access eFSAP.

• Pending – RO submitted the amendment to FSAP for review.
• Request for Information – FSAP has returned an amendment to the RO to request additional information regarding the amendment. Note: Responses to Requests for Information must be uploaded to the appropriate section of the APHIS/CDC Form 1. Once you have uploaded the information, select Edit on the amendment, and click Return to Agency to send it to FSAP.
• Draft – RO has created an amendment by clicking Save, but has not selected Submit.
• Approved – Amendment was approved by FSAP.
• Rejected – Amendment was rejected by FSAP.
• Deactivated – Amendment was withdrawn by RO.

If you need to withdraw an amendment for any reason (e.g., the request was submitted as “All Other Amendments” and should be a self-service request, or the expected change is no longer required), you can:

1. Log into eFSAP and select Form 1.
2. Select the action View and select Edit next to the amendment that should be withdrawn.
3. Select Withdraw to inactivate amendment.

How you upload supporting documentation in eFSAP depends on what you are doing. Each section of the form contains an upload area that should be used for form-specific documents.

1. 1. Log into eFSAP and click on the Form 1 button.
   2. Select the applicable section of the form.
   3. Scroll to the bottom of the section page to find the “Upload an Entity Document” area.
   4. Select Browse, navigate to the document that you want to upload, and click Upload. All uploaded documents are assigned a unique document identifier and further sorted by type of document.
      1. Some characters are unusable in the eFSAP system. Do not upload documents with a number sign (#), semi-colon (;), or comma (,).

For APHIS/CDC Form 1 supporting documentation not associated with a specific section (e.g., responses to inspection report requests for information, Science Office requests for information, or updated plans in response to an amendment):

1. Log into eFSAP.
2. Scroll to the bottom of the home page to find the “Upload an Entity Document” area.
3. Select Browse, navigate to the document that you want to upload, and click Upload. All uploaded documents are assigned a unique document identifier and further sorted by type of document.
   1. Some characters are unusable in the eFSAP system. Do not upload documents with a number sign (#), semi-colon (;), or comma (,).

If you accidentally remove someone from your registration:

1. Click Form 1.
2. Select the action Amend.
3. Select Section 4 Amendment from the dropdown and click OK.
4. Select View Inactivated Users, and click Reapply in the Inactive Users list under Section 4 of your Form 1.

Once they have been reapplied, notify your POC by sending a message via the discussion box in Section 4 of your registration (Form 1).

 Section 1 – Change Entity Physical or Additional Address

1. Log into eFSAP.
2. Click on Form 1. Select the action Amend.
3. Select Section 1 Amendment from the dropdown menu.
4. Make updates to the Section 1 as needed.
   1. If the address change involves registered space, submit a new “all other amendments” to request the addition or removal of registered space.
   2. If the address change will impact the information provided in Section 5C, submit an amendment to update 5C: Entry Requirements for Federal Select Agent Program Inspectors
5. Click the Save button.

Section 4 – Add/Remove/Modify/Reactivate Personnel

1. Log into eFSAP.
2. Click on Form 1. Select the action Amend.
3. Select Section 4: Add/Remove/Modify/Reactivate Personnel from the dropdown menu.
4. To make the following changes, please see the additional instructions in the Form 1 instructions:
   1. Add a new individual without a Department of Justice (DOJ) number.
   2. Add a new individual with a known DOJ number.
   3. Remove an individual.
   4. Change the role of an individual.
      1. Adding or removing the role of Principal Investigator (PI) will require additional documentation.
   5. Add tier 1 access or responsibility for inventory.
   6. Update name of the individual.
   7. Reactivate an individual.
5. Click the Save button.

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

1. Log into eFSAP.
2. Click on Form 1. Select the action Amend.
3. Select Section 5A: Modify Entity Wide Security and Incident Response from the dropdown menu.
4. Enter a brief description in the cover letter stating the requested change. Click OK.
5. Update Section 5A as needed.
6. Click Save and Return to Amendment.
7. Click Submit.
8. FSAP POC will review the change to ensure accuracy and completeness. Additional information may be requested before approving the amendment.

Section 5B – Modify Entity-Wide Biosafety/Biocontainment

1. Log into eFSAP.
2. Click on Form 1. Select the action Amend.
3. Select Section 5B: Modify Entity Wide Biosafety/Biocontainment from the dropdown menu.
4. Enter a brief description in the cover letter stating the requested change. Click OK.
5. Update Section 5B as needed.
6. Click Save and Return to Amendment.
7. Click the Submit button.
8. FSAP POC will review the change to ensure accuracy and completeness. Additional information may be requested before approving the amendment.

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

1. Log into eFSAP.
2. Click on Form 1. Select the action Amend.
3. Select Section 5C: Modify Entry Requirements for Federal Select Agent Program Inspectors from the dropdown menu.
4. Enter a brief description in the cover letter stating the requested change. Click OK.
5. Update Section 5C as needed.
6. Click Save and Return to Amendment.
7. Click the Submit button.
8. FSAP POC will review the change to ensure accuracy and completeness. Additional information may be requested before approving the amendment.

Section 7B – Add/Remove/Modify Strains and Serotypes

To add or modify strains:

1. Log into eFSAP.
2. Click on Form 1. Select the action Amend.
3. Select Section 7B – Add/Remove/Modify Strains and Serotypes from the dropdown menu.
4. Update Section 7B.
   1. To add:
      1. Click Open.
      2. Select the agent or toxin from the drop down list of your approved agents and toxins.
      3. Type in the strain to be added.
      4. Select the PI to be assigned.
         1. You can select multiple PIs by holding down the control key and selecting the PI.
         2. If the agent is assigned to every PI at the entity you can click Assign to entity.
      5. Click Add Agent and Strain.
      6. Click Save.
   2. To modify:
      1. Select Edit to the right of the strain of agent or toxin from your list.
      2. Make strain name or PI assignment changes.
      3. Click Save.

To remove strains:

1. Log into eFSAP.
2. Click on Form 1. Select the action Amend.
3. Select Section 7B – Add/Remove/Modify Strains and Serotypes from the dropdown menu.
4. Update Section 7B.
   1. Click Edit for the strain you wish to remove.
   2. Click Delete.
   3. Then click Save.
      1. If you remove all strains for an agent or toxin, Section 3 will automatically be updated to show it is no longer possessed. This does not remove the agent from your registration.
      2. If you would like to remove an agent from your registration, you must also submit an “all other amendments” and request the change.
5. Click the Save button.