Compliance APHIS/CDC Form 1 FAQ's
FAQ's by Topic
- Due Diligence
- Inactivated Bacillus anthracis
- Legislature, Regulation, and Guidelines
- Personnel Suitability
- Report of the Identification of a Select Agent or Toxin
- Responsible Official
- Restricted Experiments
- Security Risk Assessments
- Select Agents and Toxins
Who must register with the Federal Select Agent Program?
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 Select Agents and Toxins (DSAT) or U.S. Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS)/ Agriculture Select Agent Services (AgSAS) (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 at http://www.selectagents.gov/Regulations.html.
How do I register with the Federal Select Agent Program?
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 at http://www.selectagents.gov/form1.html.
What is a "certificate of registration"?
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.
We have select agents on the HHS list as well as on the USDA list. Do we have to register with both HHS (CDC) and USDA (APHIS)?
No. You may submit your application for registration to DSAT or AgSAS. DSAT and AgSAS 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 which agency should the application be submitted?
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 DSAT.
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 AgSAS.
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 DSAT or AgSAS, but not both.
DSAT: submit the completed registration application to the CDC via email (firstname.lastname@example.org), FAX (404-718-2096), or mail (Division of Select Agents and Toxins, 1600 Clifton Rd MS A-46, Atlanta, GA 30329)
AgSAS: submit the completed registration application to the APHIS via email (AgSAS@aphis.usda.gov), FAX (301-734-3652), or mail (Agriculture Select Agent Services, 4700 River Road, Unit 2, Mailstop 22, Cubicle 1A07, Riverdale, MD 20737).
If you have questions while completing the application, you can send the questions to email@example.com or AgSAS@aphis.usda.gov. A listing of HHS and USDA select biological agents and toxins is available at http://www.selectagents.gov/SelectAgentsandToxinsList.html.
How long will it take for my application for registration with the Federal Select Agent Program to be approved?
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.
How do I inquire as to the status of my APHIS/CDC Form 1 application?
A designated DSAT or AgSAS 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.
When and how do I make a change to the registration after it is approved?
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 at http://www.selectagents.gov/form1.html.
Who may make a change to the registration?
The RO may request a change to the registration. Further information can be found in the RO Guidance Document. 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.
Does the shipping and receiving area need to be listed on the entity’s certificate of registration?
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.
My entity packages identified select agents and toxins in the shipping and receiving area. Does my entity list the shipping and receiving area on the entity's certificate of registration and must requirements in the select agent regulations be met for this area?
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.
What is the difference between an entity application number and the registration number requested in Section 1A of the APHIS/CDC Form 1?
The entity application number is assigned to an entity after the Federal Select Agent Program (FSAP or Program) (comprised of the Centers for Disease Control and Prevention/ Division of Select Agents and Toxins (DSAT) and the Animal and Plant Health Inspection Services/ Agriculture Select Agent Services (AgSAS)) has accepted the initial application. It will begin with “AGR” for AgSAS-led entities and “CDC” for DSAT-led entities. The entity application number will remain the same throughout the entity’s registration with the Federal Select Agent Program. Please refer to Section 1A – Entity Information in the Form 1 Instructions document.
The entity application number (referred to as “entity ID”) is included in letters used by the FSAP to issue a unique identifying number for an individual identified by an entity as requiring a security risk assessment. You may also ask your file manager for your entity application number.
The registration number is assigned by the FSAP upon the entity’s registration with the Program. Please note that the registration number changes each time the entity’s certificate of registration is renewed. This number can be found on each registration certificate issued by the FSAP.
Does section 1C (Entity Abstract) of the APHIS/CDC Form 1 have to be completed with every amendment or only at the time of renewal or a new application?
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.
Do rooms containing entity’s registration documents (i.e., application forms, amendments, requests or reports) such as the Responsible Official (RO)’s or alternate RO’s office need to be registered as select agent laboratories?
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.
Does an entity with multiple buildings spread across a very large campus need to list all buildings in Section 1 “additional physical addresses” box?
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 at: http://www.selectagents.gov/form1.html for additional information.
Should Section 3 be completed for each Principal Investigator (PI), or the entity as a whole?
Section 3 should include all select agents and toxins that the entity possesses or wishes to possess for the entity as a whole.
Does the APHIS/CDC Form 1 have “N/A” choice for those questions that do not apply to the entity?
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.
Do I need to list a visitor (maintenance worker or visiting scientist) on the APHIS/CDC Form 1 if the individual will be continuously escorted and not have access to a select agent or toxin?
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.
Does a supervising Principal Investigator (PI) need to be listed for support staff (individuals who provides an indirect service in support of the direct work with select agents or toxins, does not work with select agents or toxins or select agent infected animals, bedding or plant hosts, but could potentially gain access to select agents/toxins)?
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.
Can more than one supervising Principal Investigator (PI) be listed for personnel on Section 4A?
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.
Should researchers working in registered areas, but not with select agents or toxins, be listed on the entity’s registration?
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.
How should laboratory assistants be listed in Section 4A?
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.
Principal Investigator/Work Performed/Rooms
For entities with large inventories of select agents that have been genetically modified, does each isolate need to be listed in Section 7B of the APHIS/CDC Form 1?
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 (http://www.selectagents.gov/form1.html) is available to copy and paste strain information into the spreadsheet.
When should an entity update Section 3 to accurately reflect possession of select agents and toxins?
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.
Who should be listed on the entity’s registration as responsible for a laboratory’s select agent inventory in Section 7C, Question 5?
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.
Does Attachment A (Work with Toxins) need to be completed for entities that are not registered for select toxins but identify toxins as result of diagnosis, verification or proficiency testing?
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 FAQ's (www.selectagents.gov/faq-reporting.html) regarding questions involving the identification of a select agent or toxins during diagnosis, verification, or proficiency testing.
How are BSL-3 enhanced and ABSL-3 enhanced indicated as designations for safety levels in Section 6B on APHIS/CDC Form 1?
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.
Can an entity still submit strain information on an Excel spreadsheet as was accepted previously?
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.
Is adding a new employee considered an amendment to the application?
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.
How is an amendment to the certificate of registration made (i.e. remove an RO, add personnel, add Tier 1 agent, remove a room, etc.)?
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.
When removing an individual listed on Sections 4A, 4B or 4C, do I need to submit a complete Section 4?
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.