N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 61-1.16

Current through Register Vol. 46, No. 45, November 2, 2024

Section 61-1.16 - Biological containment levels

The following levels of biological containment (HV or host-vector systems) for prokaryotes are established:

(a) HV1. A host-vector system which provides a moderate level of containment. Specific systems:

(1) EK1. The host is always E. coli K-12 or a derivative thereof, and the vectors include nonconjugative plasmids (e.g.,pSC101, ColE1, or derivatives thereof) and variants of bacteriophage, such as. The E. coli K-12 hosts shall not contain conjugation-proficient plasmids, whether autonomous or integrated, or generalized transducing phages.

(2) Other prokaryotes. Hosts and vectors shall be, at a minimum, comparable in containment to E. coli K-12 with a nonconjugative plasmid or bacteriophage vector.

(b) HV2. These are host-vector systems shown to provide a high level of biological containment as demonstrated by data from suitable tests performed in the laboratory. Escape of the recombinant DNA either via survival of the organisms or via transmission of recombinant DNA to other organisms should be less than 1/108 under specified conditions. Specific systems:

(1) For EK2 host-vector systems in which the vector is a plasmid, no more than one in 108 host cells should be able to perpetuate a cloned DNA fragment under the specified nonpermissive laboratory conditions designed to represent the natural environment, either by survival of the original host or as a consequence of transmission of the cloned DNA fragment.

(2) For EK2 host-vector systems in which the vector is a phage, nor more than one in 108 phage particles should be able to perpetuate a cloned DNA fragment under the specified nonpermissive laboratory conditions designed to represent the natural environment either:

(i) as a prophage (in the inserted or plasmid form) in the laboratory host used for phage propagation; or

(ii) by surviving in natural environments and transferring a cloned DNA fragment to other hosts (or their resident prophages).

(c) Responsibility. HV1 systems other than E. coil K-12, and HV2 host-vector systems, may not be designated as such until they have been certified by the director, NIH.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 61-1.16