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 › Containment › Section 61-1.14 - Physical containment levels; P4 level

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
Laboratory practices.
(1) Laboratory doors shall be kept closed
						while experiments are in progress.
(2) Work surfaces shall be decontaminated
						following the completion of the experimental activity and immediately following
						spills of organisms containing recombinant DNA molecules.
(3) All laboratory wastes shall be
						steam-sterilized (autoclaved) before disposal. Other contaminated materials
						such as glassware, animal cages, laboratory equipment, and radioactive wastes
						shall be decontaminated by a method demonstrated to be effective before
						washing, reuse, or disposal.
(4)
						Mechanical pipetting devices shall be used; pipetting by mouth is
						prohibited.
(5) Eating, drinking,
						smoking, and storage of food are not permitted in the P4 facility.
(6) Persons shall wash their hands after
						handling organisms containing recombinant DNA molecules and when they leave the
						laboratory.
(7) Care shall be
						exercised to minimize the creation of aerosols. For example, manipulations such
						as inserting a hot inoculating loop or needle into a culture, flaming an
						inoculation loop or needle so that it splatters, and forceful ejection of
						fluids from pipettes or syringes shall be avoided.
(8) Biological materials to be removed from
						the P4 facility in a viable or intact state shall be transferred to a
						non-breakable sealed container, which is then removed from the P4 facility
						through a pass-through disinfectant dunk tank or fumigation chamber.
(9) No materials, except for biological
						materials that are to remain in a viable or intact state, shall be removed from
						the P4 facility unless they have been steam-sterilized (autoclaved) or
						decontaminated by a means demonstrated to be effective as they pass out of the
						P4 facility. All wastes and other materials as well as equipment not damaged by
						high temperature or steam shall be steam-sterilized in the double-door
						autoclave of the P4 facility. Other materials which may be damaged by
						temperature or steam shall be removed from the P4 facility through a
						pass-through fumigation chamber.
(10) Materials within the class III cabinets
						shall be removed from the cabinet system only after being steam-sterilized in
						an attached double-door autoclave or after being contained in a non-breakable
						sealed container, which is then passed through a disinfectant dunk tank or a
						fumigation chamber.
(11) Only
						persons whose entry into the P4 facility is required to meet program or support
						needs shall be authorized to enter. Before entering, such persons shall be
						advised of the nature of the research being conducted and shall be instructed
						as to the appropriate safeguards to ensure their safety. They shall comply with
						instructions and all other required procedures.
(12) Persons under 18 years of age shall not
						enter the P4 facility.
(13)
						Personnel shall enter into and exit from the P4 facility only through the
						clothing change and shower rooms. Personnel shall shower at each egress from
						the P4 facility. Air locks shall not be used for personnel entry or exit except
						for emergencies.
(14) Street
						clothing shall be removed in the outer side of the clothing-change area and
						kept there. Complete laboratory clothing, including undergarments, head cover,
						shoes, and either pants and shirts or jumpsuits, shall be used by all persons
						who enter the P4 facility. Upon exit, personnel shall store this clothing in
						lockers provided for this purpose or discard it into collection hampers before
						entering the shower area.
(15) The
						universal biohazard sign is required on the P4 facility access doors and on all
						interior doors to individual laboratory rooms where experiments are conducted.
						The sign shall also be posted on freezers, refrigerators, or other units used
						to store organisms containing recombinant DNA molecules.
(16) An insect and rodent control program
						shall be instituted.
(17) Animals
						and plants not related to the experiment shall not be permitted in the
						laboratory in which the experiment is being conducted.
(18) Vacuum outlets shall be protected by
						filter and liquid disinfectant traps.
(19) Use of the hypodermic needle and syringe
						shall be avoided when alternate methods are available.
(20) The laboratory shall be kept neat and
						clean.
(21) If experiments
						involving other organisms which require lower levels of containment are to be
						conducted in the P4 facility concurrently with experiments requiring P4-level
						containment, they shall be conducted in accordance with all P4-level laboratory
						practices specified in this section.