SELECT AGENT LISTING

GENETIC ELEMENTS, RECOMBINANT NUCLEIC ACIDS, AND RECOMBINANT ORGANISMS:

1. Viruses, bacteria, fungi, and toxins listed that have been genetically modified.
2. Select agent viral nucleic acids (synthetic or naturally derived, contiguous or fragmented, in host chromosomes or in expression vectors) that can encode infectious and/or replication competent forms of any of the select agent viruses.
3. Nucleic acids (synthetic or naturally derived) that encode for the functional form(s) of any of the toxins listed if the nucleic acids:

(i) are in a vector or host chromosome;

(ii) can be expressed in vivo or in vitro; or

(iii) are in a vector or host chromosome and can be expressed in vivo or in vitro. 

OTHER RESTRICTIONS:

·         Experiments utilizing recombinant DNA that involve the deliberate transfer of a drug resistance trait to the listed agents that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, eternity medicine, or agriculture.

·       Experiments involving deliberate formation of recombinant DNA containing genes for the biosynthesis of listed toxin lethal for vertebrates at an LD50 <100 ng/kg body weight

      EXCLUSIONS:

1.      Any select agent or toxin that is in its naturally occurring environment provided it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. 

2.      Non-viable select agent organisms or nonfunctional toxins. 

3.      Fixed tissues that bear or contain select agents or toxins.*

4.      Genetic elements or sub-units of agents or toxins, if the genetic elements or sub-units are not capable of causing disease.*

5.      The vaccine strain of Junin virus (Candid #1).

6.      The vaccine strain of Rift Valley fever virus (MP-12).

7.      Venezuelan Equine encephalitis virus vaccine strain TC-83. 

8.      The medical use of toxins for patient treatment.

9.      The following toxins (in the purified form or in combinations of pure and impure forms) if the aggregate amount under the control of a principal investigator does not, at any time, exceed the amount specified:

* The importation and interstate movements of these nonviable agents, fixed tissues, and genetic elements or subunits are still subject to the permit requirements under 9 CFR part 122.

Animal and Plant Health Inspection Service  (APHIS) Regulated Plant Pathogens

Viruses:

·         Plum pox potyvirus

Fungi:

·         Peronosclerospora philippinensis

·         Phakopsora pachyrhizi

·         Sclerophthora rayssiae var. zeae

·         Synchytrium endobioticum

Bacteria:

·         Liberobacter africanus

·         Liberobacter asiaticus 

·         Ralstonia solanacearum, race 3, biovar 2

·         Xanthomonas oryzae pv. oryzicola

·         Xylella fastidiosa (citrus variegated chlorosis strain)