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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 HHS's Centers for Disease Control and Prevention (CDC) or USDA's Animal and Plant Health Inspection Service (APHIS) (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 .
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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. Instructions for completing the APHIS/CDC Form 1 application can be found at http://www.selectagents.gov/RegistrationForm.html . If you have questions while completing the application, you can send the questions to lrsat@cdc.gov or ASAP@aphis.usda.gov.
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The certificate of registration is the document issued by the Federal Select Agent Program that lists the specific select agents and/or toxins that an individual or entity is authorized to possess and/or transfer; and those specific activities that are authorized to occur, persons authorized access, and the locations (rooms, buildings, or a group of buildings) where select agents or toxins are authorized to be present. Although the certificate of registration is required to be amended to reflect current circumstances, a certificate of registration must be reauthorized at least every three years from the date it was initially issued or renewed.
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The APHIS/CDC Form 1 can be found at http://www.selectagents.gov/RegistrationForm.html.
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Instructions for completing the APHIS/CDC Form 1 application as well as amending an approved APHIS/CDC Form 1 can be found at http://www.selectagents.gov/RegistrationForm.html.
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No. You may submit your application for registration to CDC or APHIS. CDC and APHIS work together to provide a single point of contact. This single point of contact is referred to as the "lead agency", and as such, is responsible for coordinating all activities and communications with respect to your registration, including coordination with the non-lead agency.
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To apply for a certificate of registration that lists only "HHS select agents and toxins" (42 CFR 73.3), an individual or entity must submit the completed APHIS/CDC Form 1 to CDC.
To apply for a certificate of registration that lists only "Veterinary Services (VS) select agents and toxins" and/or "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 APHIS.
To apply for a certificate of registration that lists any combination of "HHS select agents and toxins," "VS select agents and toxins," "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 CDC or APHIS, but not both.
CDC: the Responsible Official (RO) can submit the completed registration application to the CDC via email (lrsat@cdc.gov), FAX (404-718-2096), or mail (Division of Select Agents and Toxin, 1600 Clifton Rd MS A-46, Atlanta, GA 30333)
APHIS: the RO can submit the completed registration application to APHIS via email (ASAP@aphis.usda.gov), FAX (301-734-3652) or mail (Animal and Plant Health Inspection Service, Agriculture Select Agent Program, 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 lrsat@cdc.gov or ASAP@aphis.usda.gov . A listing of HHS and USDA select biological agents and toxins is available at http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html.
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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.
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A designated CDC or APHIS 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. Any requests regarding your application should be communicated to your designated representative.
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Prior to any change (e.g., personnel, space, work, or agents), the RO must apply for an amendment to the entity's certificate of registration. The amendment must be approved prior to the requested changes being implemented.
Instructions for completing an amendment can be found at http://www.selectagents.gov/RegistrationForm.html.
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The RO may request a change to the registration. Further information can be found in the
Responsible Official 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 ARO can sign documents and submit forms and information in support of those decisions.
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Not in all cases. The shipping and receiving area would have to be listed on the entity's certificate of registration if packaging or unpackaging of a select agent or toxin is performed in these areas. However, if select agents and toxins are packaged for shipment in the laboratory and labeled generically as hazardous material , then the shipping and receiving area would not have to be listed on the entity's certificate of registration. Under this situation, individuals associated with the shipping and receiving area will NOT need to undergo a security risk assessment since the package should not be identified as containing select agents or toxins until it is verified by the intended recipient. However, the entity's security plan must contain procedures on 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 at all times, including 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.
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Yes. The shipping and receiving area must be listed on the entity’s certificate of registration since the area will temporarily store select agents and toxins. The shipping and receiving area must meet all the requirements outlined in the select agent regulations similar to other registered spaces listed on the entity’s certificate of registration. If the area will house Tier 1 select agents and toxins, the area must meet all provisions associated with Tier 1 requirements. This includes all individuals who will have access to the select agents or toxins. If those individuals will have access to Tier 1 select agents or toxins, the individuals must 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.
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