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 61-1.13 - Physical containment levels; P3 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 laboratory area in which
						recombinant DNA materials are handled.
(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, manipulation 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) Contaminated materials that are to be
						steam-sterilized (autoclaved) or decontaminated at a site away from the
						laboratory shall be placed in a durable leak-proof container, which is closed
						before removal from the laboratory.
(9) Entry into the laboratory shall be
						through a controlled access area. Only persons who have been advised of the
						nature of the research being conducted shall enter the controlled access area.
						Only persons required on the basis of program or support needs shall be
						authorized to enter the laboratory. Such persons shall be advised of the nature
						of the research being conducted before entry, and shall comply with all
						required entry and exit procedures.
(10) Persons under 16 years of age shall not
						enter the laboratory.
(11) The
						universal biohazard sign shall be posted on the controlled access area door and
						on all laboratory doors when experiments requiring P3-level containment are in
						progress. Freezers and refrigerators or other units used to store organisms
						containing recombinant DNA molecules shall also be posted with the universal
						biohazard sign.
(12) An insect and
						rodent control program shall be instituted.
(13) Laboratory clothing that protects street
						clothing (e.g., long-sleeve solid-front or wrap-around gowns, no-button or
						slip-over jackets) shall be worn in the laboratory. Front-button laboratory
						coats are unsuitable. Laboratory clothing shall not be worn outside the
						laboratory and shall be decontaminated before it is sent to the
						laundry.
(14) Raincoats, overcoats,
						topcoats, coats, hats, caps, and such street outerwear shall not be kept in the
						laboratory.
(15) Gloves shall be
						worn when handling materials requiring P3 containment. They shall be removed
						aseptically immediately after the handling procedure and
						decontaminated.
(16) Animals and
						plants not related to the experiment shall not be permitted in the
						laboratory.
(17) Vacuum outlets
						shall be protected by filter and liquid disinfectant traps.
(18) Use of hypodermic needle and syringe
						shall be avoided when alternative methods are available.
(19) The laboratory shall be kept neat and
						clean.
(20) If experiments
						involving other organisms which require lower levels of containment are to be
						conducted in the same laboratory concurrently with experiments requiring
						P3-level physical containment, they shall be conducted in accordance with all
						P3-level laboratory practices.