New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Classes of Recombinant DNA Activity › Section 61-1.20 - Classes of recombinant DNA activity

Current through Register Vol. 46, No. 28, July 10, 2024
This section discusses activities involving recombinant
						  DNA. The activities are divided into four classes corresponding to those set
						  forth in part III of the revised NIH guidelines effective August 27, 1982. The
						  words
experiment
and
experiments
are to be
						  read as referring to recombinant DNA activity as defined in article 32-A of the
						  Public Health Law. The classes and their respective requirements are:
(III-A) Experiments which require specific
						NIH and institutional biosafety committee (IBC) approval before initiation of
						the experiment.
(III-B) Experiments
						which require IBC approval before initiation of the experiment.
(III-C) Experiments which require IBC
						notification at the time of initiation of the experiment.
(III-D) Experiments which are exempt from the
						NIH guidelines and as such may come under section
						61-1.3(c) 
						of this Subpart.
If an experiment fall into both class III-A and one of
						  the other classes, the rules pertaining to class III-A must be followed. If an
						  experiment falls into class III-D and into either class III-B or III-C as well,
						  it can be considered as a class III-D activity.
Changes in containment levels from those specified here
						  may not be instituted without the express approval of the Director,
						  NIH.
(III-A)
Experiments that require NIH and institutional biosafety committee
						(IBC) approval before initiation.
Experiments in this category cannot
						be initiated without specific approval by NIH. The containment conditions for
						such experiments will be set by NIH at the time of approval. Such experiments
						also require the approval of the IBC before initiation. Specific experiments
						already approved in this category and the appropriate containment conditions
						are listed in appendices D and F of the NIH guidelines. If an experiment is
						similar to those listed in appendices D and F, NIH Office of Recombinant DNA
						Activities (ORDA) may determine appropriate containment conditions according to
						case precedents.
(III-A-1) Deliberate
						formation of recombinant DNAs containing genes for the biosyntheses of toxic
						molecules lethal for vertebrates at an LD50 of less than 100 nanograms per
						kilogram body weight (
e.g.,
microbial toxins such as the
						botulinum toxins, tetanus toxin, diphtheria toxin,
Shigella
						dysenteriae
neurotoxin). Specific approval has been given for the
						cloning in
E. coli
K-12 of DNAs containing genes coding for the
						biosynthesis of toxic molecules which are lethal to vertebrates at 100
						nanograms to 100 micrograms per kilogram body weight. Containment levels for
						these experiments are specified in appendix F of the NIH guidelines.
(III-A-2) Deliberate release intto the
						environment of any organism containing recombinant DNA.
(III-A-3) Deliberate transfer of a drug
						resistance trait to microorganisms that are not known to acquire it naturally,
						if such acquisition could compromise the use of the drug to control disease
						agents in human or veterinary medicine or agriculture.