Statutes, codes, and regulations
New York Codes, Rules and Regulations
Title 10 - DEPARTMENT OF HEALTHChapter II - Administrative Rules and RegulationsSubchapter E - Food And Drug Products; ResearchPart 61 - ResearchSubpart 61-1 - Recombinant Dna Research And Activity
Containment
Section 61-1.14 - Physical containment levels; P4 level

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 61-1.14

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Current through Register Vol. 46, No. 45, November 2, 2024
Section 61-1.14 - Physical containment levels; P4 level
(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.
(b)Containment equipment.
(1) Experimental procedures involving organisms that require P4-level physical containment shall be conducted either in:
(i) a class III cabinet system; or in
(ii) class I or class II cabinets that are located in a specially designed area in which all personnel are required to wear one-piece positive-pressure isolation suits.
(2) Laboratory animals involved in experiments requiring P4-level physical containment shall be housed either in cages contained in class III cabinets or in partial-containment caging systems (such as horsfall units, open cages placed in ventilated enclosures, or solid-wall and -bottom cages covered by filter bonnets, or solid-wall and -bottom cages placed on holding racks equipped with ultraviolet irradiation lamps and reflectors) that are located in a specially designed area in which all personnel are required to wear one-piece positive-pressure suits.
(3) Alternative selection of containment equipment. Experimental procedures involving a host-vector system that provides a one-step higher level of biological containment than that specified can be conducted in the P4 facility using containment equipment requirements specified for the P3 level of physical containment. Alternative combinations of containment safeguards are shown in Table II.

Table II

POSSIBLE COMBINATIONS OF CONTAINMENT SAFEGUARDS

Classification of experiment

Alternate combinations of physical and biological containment

Physical Containment
Physical containment

Biological containment*

Laboratory design specified for:

Laboratory practices specified for:

Containment equipment specified for:

Biological containment

P4HV1P4P4P4HV1
P4HV1P4P4 P4**HV2

* See section 61-1.16 of this Subpart for description of biological containment.

** In the case gloves shall be worn, in addition to the clothing requirements specified in paragraph (a)(14) of this section.

(c)Special laboratory design.
(1) The laboratory shall be located in a restricted-access facility which is either a separate building or a clearly demarcated and isolated zone within a building. Clothing-change areas and shower rooms shall be provided for personnel entry and egress. These rooms shall be arranged so that personnel leave through the shower area to the change room. A double-door ventilated vestibule or ultraviolet air lock shall be provided for passage of materials, supplies, and equipment which are not brought into the P4 facility through the change room area.
(2) Walls, floors, and ceilings of the P4 facility are constructed to form an internal shell which readily allows vapor-phase decontamination and is animal- and insect-proof. All penetrations through these structures and surfaces are sealed. (The integrity of the walls, floors, ceilings, and penetration seals should ensure adequate containment of a vapor-phase decontaminant under static pressure conditions. This requirement does not imply that these surfaces must be airtight.)
(3) A foot-, elbow-, or automatically operated hand-washing facility shall be provided near the door within each laboratory in which experiments involving recombinant DNA are conducted in open-face biological safety cabinets.
(4) Central vacuum systems are permitted. The system, if provided, shall not serve areas outside the P4 facility. The vacuum system shall include in-line HEPA filters near each use point or service cock. The filters shall be installed so as to permit in-place decontamination and replacement. Water supply and liquid and gaseous services provided to the P4 facility shall be protected by devices that prevent backflow.
(5) Drinking water fountains shall not be installed in laboratory or animal rooms of the P4 facility. Foot-operated water fountains are permitted in the corridors of the P4 facility. The water service provided to such fountains shall be protected from the water services to the laboratory areas of the P4 facility.
(6) Laboratory doors shall be self-closing.
(7) A double-door autoclave shall be provided for sterilization of material passing out of the P4 facility. The autoclave doors shall be interlocked so that both doors will not be open at the same time.
(8) A pass-through dunk tank or fumigation chamber shall be provided for removal from the P4 facility of material and equipment that cannot be heat-sterilized.
(9) All liquid effluents from the P4 facility shall be collected and decontaminated before disposal. Liquid effluents from biological safety cabinets and laboratory sinks shall be sterilized by heat. Liquid effluents from the shower and hand washing facilities may be inactivated by chemical treatment. HEPA filters shall be installed in all vents from effluent drains.
(10) An individual supply and exhaust-air ventilation system shall be provided. The system shall maintain pressure differentials and directional air flow as required to ensure inflow from areas outside the facility toward areas of highest potential risk within the facility. The system shall be designed to prevent the reversal of air flow. The system shall sound an alarm in the event of system malfunction.
(11) Air within individual laboratories of the P4 facility may be recirculated if HEPA-filtered.
(12) The exhaust air from the P4 facility shall be HEPA-filtered and discharged to the outdoors so that it is dispersed clear of occupied buildings and air intakes. The filter chambers shall be designed to allow in situ decontamination before removal and to facilitate certification testing after replacement.
(13) The treated exhaust-air from class I and class II biological safety cabinets may be discharged directly to the laboratory room environment or to the outdoors. The treated exhaust-air from class III cabinets shall be discharged to the outdoors. If the treated exhaust-air from these cabinets is to be discharged to the outdoors through the P4 facility exhaust air system, it shall be connected to this system so as to avoid any interference with the air balance of the cabinets or the facility exhaust air system.
(14) As noted in paragraph (b)(1) of this section, the P4 facility may contain specially designed areas in which all personnel are required to wear one-piece positive-pressure isolation suits. Such areas shall be airtight. The exhaust-air from the suit area shall be filtered by two sets of HEPA filters installed in series, and a duplicate filtration unit and exhaust fan shall be provided. The air pressure within the suit area shall be less than that in any adjacent area. An emergency lighting system, communication systems, and power source shall be provided. A double-door autoclave shall be provided for sterilization of all waste materials to be removed from the suit area. Personnel who enter this area shall wear a one-piece positive-pressure suit that is ventilated by a life-support system. The life-support system shall be provided with alarms and emergency backup air. Entry to this area is through an airlock fitted with airtight doors. A chemical shower area shall be provided to decontaminate the surfaces of the suit before removal.

Footnotes

* See section 61-1.16 of this Subpart for description of biological containment.

** In the case gloves shall be worn, in addition to the clothing requirements specified in paragraph (a)(14) of this section.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 61-1.14