[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR73.16]



[Page 450-451]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 73_SELECT AGENTS AND TOXINS--Table of Contents

 

Sec. 73.16  Transfers.



    (a) Except as provided in paragraphs (c) and (d) of this section, a 

select agent or toxin may only be transferred to individuals or entities 

registered to possess, use, or transfer that agent or toxin. A select 

agent or toxin may only be transferred under the conditions of this 

section and must be authorized by CDC or APHIS prior to the transfer.\4\

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    \4\ This section does not cover transfers within an entity when the 

sender and the recipient are covered by the same certificate of 

registration.

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    (b) A transfer may be authorized if:

    (1) The sender:

    (i) Has at the time of transfer a certificate of registration that 

covers the particular select agent or toxin to be transferred and meets 

all requirements in this part,

    (ii) Meets the exemption requirements for the particular select 

agent or toxin to be transferred, or



[[Page 451]]



    (iii) Is transferring the select agent or toxin from outside the 

United States and meets all import requirements.

    (2) At the time of transfer, the recipient has a certificate of 

registration that includes the particular select agent or toxin to be 

transferred and meets all of the requirements of this part.

    (c) A select agent or toxin that is contained in a specimen for 

proficiency testing may be transferred without prior authorization from 

CDC or APHIS provided that, at least seven calendar days prior to the 

transfer, the sender reports to CDC or APHIS the select agent or toxin 

to be transferred and the name and address of the recipient.

    (d) On a case-by-case basis, the HHS Secretary may authorize a 

transfer of a select agent or toxin, not otherwise eligible for transfer 

under this part under conditions prescribed by the HHS Secretary.

    (e) To obtain authorization for transfer, APHIS/CDC Form 2 must be 

submitted.

    (f) The recipient must submit a completed APHIS/CDC Form 2 within 

two business days of receipt of a select agent or toxin.

    (g) The recipient must immediately notify CDC or APHIS if the select 

agent or toxin has not been received within 48 hours after the expected 

delivery time, or if the package containing select agents or toxins has 

been damaged to the extent that a release of the select agent or toxin 

may have occurred.

    (h) An authorization for a transfer shall be valid only for 30 

calendar days after issuance, except that such an authorization becomes 

immediately null and void if any facts supporting the authorization 

change (e.g., change in the certificate of registration for the sender 

or recipient, change in the application for transfer).

    (i) The sender must comply with all applicable laws concerning 

packaging and shipping.