Part 61 - Research

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SubPart 61-1 - Recombinant DNA Research and Activity

Effective Date: 
Thursday, February 22, 1979
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Statutory Authority: 
Public Health Law, Section 3222

GENERAL

Section 61-1.1 - Definitions

GENERAL

Section 61-1.1 Definitions. As used in this Subpart:

(a) Commissioner means Commissioner of Health of the State of New York.

(b) Department means Department of Health of the State of New York.

(c) Guidelines means the recombinant DNA research guidelines of the National Institutes of Health of the Department of Health and Human Services, as amended and revised from time to time.

(d) NIH means the National Institutes of Health.

(e) P1, P2, P3, P4 designate levels of physical containment in order of increasing safeguards against the escape of organisms.

(f) EK1, EK2, EK3 designate levels of biological containment for E. coli K-12 host-vector systems in order of increasing inability of organisms to survive outside of laboratory conditions.

(g) Class 1, class 2, class 3, class 4, class 5 designate classes of etiologic agents in order of increasing hazard according to Classification of Etiologic Agents on the Basis of Hazard issued by the Public Health Service of the Department of Health and Human Services, as revised by NIH.

(h) Institution means any public or private entity other than an individual, including State and local government agencies.
 

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Section 61-1.2 Repealed

Effective Date: 
Friday, April 15, 1983

Section 61-1.3 - Certification

61-1.3 Certification.

(a) A certificate to engage in recombinant DNA activity will be issued by the commissioner only to an institution. Except as hereinafter provided, an institution will not be issued a certificate unless it:

(1) establishes an institutional biosafety committee (IBC) composed of members approved by the commissioner as satisfying the requirements of section 61-1.31 of this Subpart; and

(2) submits a written assurance that it:

(i) will submit each recombinant DNA project to NIH, or other Federal agency designated by NIH, for approval where such approval is required by this Subpart or the NIH guidelines;

(ii) will file reports with the commissioner when requested by him showing the progress of recombinant DNA activity engaged in at the institution;

(iii) will not engage in recombinant DNA activity in any facility which does not comply with the NIH guidelines;

(iv) will conduct training programs satisfactory to the commissioner for all workers and service personnel with duties in recombinant DNA laboratories;

(v) will carry out health monitoring programs appropriate to each recombinant DNA activity engaged in;

(vi) has an emergency plan for accidents involving potentially hazardous materials involved in recombinant DNA activity; and

(vii) will comply with the requirements of article 32-A of the Public Health law and this Subpart.

(b) An institution engaged in recombinant DNA activity subject to, and in compliance with, policies and regulations or guidelines promulgated by any agency of the Federal government for the regulation of recombinant DNA activity may submit to the commissioner copies of the documentation approved by the Federal agency, including information relating to the institutional biosafety committee of the institution. Such documentation may be accepted by the commissioner as authority for issuance of a certificate to engage in recombinant DNA activity upon the same conditions and limitations, if any, as imposed by the Federal agency.

(c) Unless the activity is prohibited by section 61-1.2 of this Subpart, an institution may be issued a certificate by the commissioner to engage in recombinant DNA activity limited to the following recombinant DNA molecules, and for such certificate shall not be required to comply with those provisions of sections 61-1.30 and 61-1.31 of this Subpart pertaining to the establishment and functioning of an institutional biosafety committee (IBC):

(1) those that are not in organisms or viruses;

(2) those that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent;

(3) those that consist entirely of DNA from a prokaryotic host, including its indigenous plasmids or viruses, when propagated only in that host (or a closely related strain of the same species) or when transferred to another host by well-established physiological means; also those that consist entirely of DNA from a eukaryotic host, including its chloroplasts, mitochondria or plasmids (but excluding viruses), when propagated only in that host (or a closely related strain of the same species);

(4) certain recombinant DNA molecules that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent, as specified in a list of such exchangers prepared and periodically revised by the director, NIH; and

(5) other classes of recombinant DNA molecules if the director, NIH, finds that they do not present a significant risk to health or the environment, and the commissioner is furnished satisfactory evidence of such finding.

(d) An institution not otherwise covered by the NIH guidelines, and not having a valid certificate pursuant to subdivision (c) of this section, is prohibited from engaging in recombinant DNA activity covered by this Subpart unless it follows the approval procedures set forth in Part VI, Voluntary Compliance, of the NIH guidelines. Upon being provided with satisfactory evidence thereof, the commissioner will issue a certificate to the institution to engage in recombinant DNA activity.

(e) Subject to the right to a hearing pursuant to section 12-a or section 16 of the Public Health Law, the commissioner may revoke or suspend the certificate of an institution upon proof that it is conducting or has conducted recombinant DNA activity requiring approval by NIH or other Federal agency designated by NIH, or approval pursuant to subdivision (d) of this section where required, without such approval.

(f) A host-vector system which is not expressly authorized by this Subpart cannot be used unless the institution registers the recombinant DNA activity with NIH and requests evaluation by NIH of the host-vector system. Cloning activity prior to certification of such host-vector system by NIH shall be limited to those genes which are characterized and are usable for evaluation of the host-vector system in its early stages of development.

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CONTAINMENT

Section 61-1.10 - Containment; general

CONTAINMENT

61-1.10 Containment; general. Good microbiological practices shall be adhered to. All personnel directly or indirectly involved in recombinant DNA activity shall be instructed in aseptic techniques and the biology of organisms used in the activity, in order that they shall be aware of potential biohazards. An emergency plan shall describe the procedures to be followed in the event of an accident contaminating personnel or the environment. The principal investigator must ensure that everyone in the laboratory is familiar with both the potential hazards of the work and the emergency plan. All personnel working with a pathogen for which an effective vaccine is available should be immunized. Serological monitoring, when appropriate, shall be provided.
 

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Section 61-1.11 - Physical containment levels; P1 level

61-1.11 Physical containment levels; P1 level.

(a) Laboratory practices.

(1) Laboratory doors shall be kept closed while experiments are in progress.

(2) Work surfaces shall be decontaminated daily, and immediately following spills of organisms containing recombinant DNA molecules.

(3) All biological wastes shall be decontaminated before disposal. Other contaminated materials, such as glassware, animal cages and laboratory equipment, shall be decontaminated before washing, reuse or disposal.

(4) Mechanical pipetting devices shall be used; pipetting by mouth is prohibited.

(5) Eating, drinking, smoking, and storage of foods 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 taken in the conduct of all procedures to minimize the creation of aerosols.

(8) Contaminated materials that are to be 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) An insect and rodent control program shall be instituted.

(10) The use of laboratory gowns, coats or uniforms is discretionary with the laboratory supervisor.

(11) Use of the hypodermic needle and syringe shall be avoided when alternative methods are available.

(12) The laboratory shall be kept neat and clean.

(b) Containment equipment. Special containment equipment is not required at the P1 level.

(c) Special laboratory design. Special laboratory design is not required at the P1 level.
 

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Section 61-1.12 - Physical containment levels; P2 level

61-1.12 Physical containment levels; P2 level.

(a) Laboratory practices.

(1) Laboratory doors shall be kept closed while experiments are in progress.

(2) Work surfaces shall be decontaminated daily, 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 means 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, 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) Contaminated materials that are to be steam-sterilized (autoclaved) or decontaminated at a site away from the laboratory shall he placed in a durable leak-proof container, which is closed before removal from the laboratory.

(9) Only persons who have been advised of the nature of the research being conducted shall enter the laboratory.

(10) The universal biohazard sign shall be posted on all laboratory access doors when experiments requiring P2 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.

(11) An insect and rodent control program shall be instituted.

(12) The use of laboratory gowns, coats, or uniforms is required. Laboratory clothing shall not be worn to the lunch room or outside of the building in which the laboratory is located.

(13) Animals not related to the experiment shall not be permitted in the laboratory.

(14) Use of the hypodermic needle and syringe shall be avoided when alternative methods are available.

(15) The laboratory shall be kept neat and clean.

(16) Experiments of lesser biohazard potential can be carried out concurrently in carefully demarcated areas of the same laboratory.

(b) Containment equipment. Biological safety cabinets shall be used to contain aerosol-producing equipment, such as blenders, lyophilizers, sonicators, and centrifuges, when used to process organisms containing recombinant DNA molecules, except where equipment design provides for containment of the potential aerosol. For example, a centrifuge may be operated in the open if a sealed head or safety centrifuge cups are used.

(c) Special laboratory design. An autoclave for sterilization of wastes and contaminated materials shall be available in the same building in which organisms containing recombinant DNA molecules are used.
 

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Section 61-1.13 - Physical containment levels; P3 level

61-1.13 Physical containment levels; P3 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 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.

(b) Containment Equipment.

(1) Biological safety cabinets shall be used for all equipment and manipulations that produce aerosols (e.g., pipetting, dilutions, transfer operations, plating, flaming, grinding, blending, drying, sonicating, shaking, centrifuging), where these procedures involve organisms containing recombinant DNA molecules, except where equipment design provides for containment of the potential aerosol.

(2) Laboratory animals held in a P3 area shall be housed in partial-containment caging systems, such as horsfall units, open cages placed in ventilated enclosures, solid-wall and -bottom cages covered by filter bonnets, or solid-wall and -bottom cages placed on holding racks equipped with ultraviolet radiation lamps and reflectors. (Note: Conventional caging systems may be used, provided that all personnel wear appropriate personal protective devices. These shall include, at a minimum, wrap-around gowns, head covers, gloves, shoe covers, and respirators. All personnel shall shower on exit from areas where these devices are required.)

(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 P3 laboratory using containment equipment specified for the P2 level of physical containment. Experimental procedures involving a host-vector system that provides a one-step lower level of biological containment than that specified can be conducted in the P3 laboratory using containment equipment specified for the P4 level of physical containment. Alternative combinations of containment safeguards are shown in Table I.

Table I

POSSIBLE COMBINATIONS OF CONTAINMENT SAFEGUARDS

Classification of experiment Alternate combinations of physical and biological containment

 

Physical containment

 

Biological containment *

 

Laboratory design specified for:

Physical Containment

Laboratory practices specified for:

 

Containment equipment
specified for:

Biological containment

P3 HV2 P3 P3 P3 HV2
  HV2 P3 P3 P4 HV1
P3 HV1 P3 P3 P3 HV1
P3 HV1 P3 P3 P2 HV2

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

(c) Special laboratory design.

(1) The laboratory shall be separated by a controlled access area from areas that are open to unrestricted traffic flow. A controlled access area is an anteroom, a change room, an air lock or any other double-door arrangement that separates the laboratory from areas open to unrestricted traffic flow.

(2) The surfaces of walls, floors, and ceilings shall be readily cleanable. Penetrations through these surfaces shall be sealed or capable of being sealed to facilitate space decontamination.

(3) A foot-, elbow-, or automatically operated hand-washing facility shall be provided near each primary laboratory exit area.

(4) Windows in the laboratory shall be sealed.

(5) An autoclave for sterilization of wastes and contaminated materials shall be available in the same building (and preferably within the controlled laboratory area) in which organisms containing recombinant DNA molecules are used.

(6) The laboratory shall have a ventilation system that is capable of controlling air movement. The movement of air shall be from areas of lower contamination potential to areas of higher contamination potential (i.e., from the controlled access area to the laboratory area). If the ventilation system provides positive pressure supply air, the system shall operate in a manner that prevents the reversal of the direction of air movement or shall be equipped with an alarm that would be actuated in the event that reversal in the direction of air movement were to occur. The exhaust air from the laboratory area shall not be recirculated to other areas of the building unless the exhaust air is filtered by HEPA filters or equivalent. The exhaust air from the laboratory area can be discharged to the outdoors without filtration or other means for effectively reducing an accidental aerosol burden provided that it can be dispersed clear of occupied buildings and air intakes.

(7) The treated exhaust-air from class I and class II biological safety cabinets may be discharged either to the laboratory or to the outdoors. The treated exhaust-air from a class III cabinet shall be discharged directly to the outdoors. If the treated exhaust-air from these cabinets is to be discharged to the outdoors through a building exhaust air system, it shall be connected to this system so as to avoid any interference with the air balance of the cabinet and the building ventilation system.
 

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Section 61-1.14 - Physical containment levels; P4 level

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

 

Biological containment *

 

Laboratory design specified for:

Physical Containment

Laboratory practices specified for:

 

Containment equipment
specified for:

Biological containment

P4 HV1 P4 P4 P4 HV1
P4 HV1 P4 P4 P4** HV2

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

** In this 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 animaland 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 his 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.

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Section 61-1.15 - Shipment of recombinant DNA

61-1.15 Shipment of recombinant DNA.* Recombinant DNA molecules contained in an organism or virus shall be shipped only as an etiologic agent under requirements of the U.S. Public Health Service and the U.S. Department of Transportation (section 72.3, part 72, title 42, and sections 173.386-.388, part 173, title 49, U.S. Code of Federal Regulations) as specified in this section:

(a) Recombinant DNA molecules contained in an organism or virus requiring P1, P2, or P3 physical containment, when offered for transportation or transported, are subject to all requirements of section 72.3(a)-(e), part 72, title 42 CFR, and sections 173.386-.388, part 173, title 49 CFR.

(b) Recombinant DNA molecules contained in an organism or virus requiring P4 physical containment, when offered for transportation or transported, are subject to the requirements listed under subdivision (a) of this section and are also subject to section 72.3(f), part 72, title 42 CFR.

* For additional information on packaging and shipment, see NIH Laboratory Safety Monograph.
 

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Section 61-1.16 - Biological containment levels

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, Co1E1, or derivatives thereof) and variants of bacteriophage, such as (lambda). 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 1/10(8) under specified conditions. Specific systems:

(1) For EK2 host-vector systems in which the vector is a plasmid, no more than one in 10(8) 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 10(8) 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. coli K-12, and HV2 host-vector systems, may not be designated as such until they have been certified by the director, NIH.
 

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CLASSES OF RECOMBINANT DNA ACTIVITY

Section 61-1.20 - Classes of recombinant DNA activity

CLASSES OF RECOMBINANT DNA ACTIVITY

61-1.20 Classes of recombinant DNA activity. 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 falls 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 into 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.

III-B Experiments that require institutional biosafety committee (lBC) approval before initiation. Investigators performing experiments in this category must submit to their IBC, prior to initiation of the experiments a registration document that contains a description of: (a) the source(s) of DNA; (b) the nature of the inserted DNA sequences; (c) the hosts and vectors to be used; (d) whether a deliberate attempt will be made to obtain expression of a foreign gene, and, if so, what protein will be produced; and (e) the containment conditions specified in the NIH guidelines. This registration document must be dated and signed by the investigator and filed only with the local IBC. The IBC shall review all such proposals prior to initiation of the experiments. Requests for lowering of containment for experiments in this category will be considered by NIH.

III-B-1. Experiments using human or animal pathogens (Class 2, Class 3, Class 4 or Class 5 agents) as host-vector systems.

III-B-1-a. Experiments involving the introduction of recombinant DNA into Class 2 agents can be carried out at P2 containment.

III-B-1-b. Experiments involving the introduction of recombinant DNA into Class 3 agents can be carried out at P3 containment.

III-B-1-c. Experiments involving the introduction of recombinant DNA into Class 4 agents can be carried out at P4 containment.

III-B-1-d. Containment conditions for experiments involving the introduction of recombinant DNA into Class 5 agents will be set on a case-by-case basis following ORDA review. A USDA permit is required for work with Class 5 agents.

III-B-2. Experiments in which DNA from human or animal pathogens (Class 2, Class 3, Class 4 or Class 5) agents is cloned in nonpathogenic prokaryotic or lower eukaryotic host-vector systems.

III-B-2-a. Recombinant DNA experiments in which DNA from Class 2 or Class 3 agents is transferred into nonpathogenic prokaryotes or lower eukaryotes may be performed under P2 containment. Recombinant DNA experiments in which DNA from Class 4 agents is transferred into nonpathogenic prokaryotes or lower eukaryotes can be performed at P2 containment after demonstration that only a totally and irreversibly defective fraction of the agent's genome is present in a given recombinant. In the absence of such a demonstration, P4 containment should be used. Specific lowering of containment to P1 for particular experiments can be approved by the IBC. Many experiments in this category will be exempt from the NIH guidelines (see III-D). Experiments involving the formation recombinant DNAs for certain genes coding for molecules toxic for vertebrates require NIH approval (see III-A-I), or must be carried out under NIH specified conditions as described in appendix F of the NIH guidelines.

III-B-2-b. Containment conditions for experiments in which DNA from Class 5 agents is transferred into nonpathogenic prokaryotes or lower eukaryotes will be determined by ORDA following a case-by-case review. A USDA permit is required for work with Class 5 agents.

III-B-3. Experiments involving the use of infectious animal or plant viruses or defective animal or plant viruses in the presence of helper virus in tissue culture systems.

Caution:Special care should be used in the evaluation of containment levels for experiments which are likely to either enhance the pathogenicity (e.g., insertion of a host oncogene) or to extend the host range (e.g., introduction of novel control elements) of viral vectors under conditions which permit a productive infection. In such cases, serious consideration should be given to raising the physical containment by at least one level. Note:Recombinant DNA molecules which contain less than two thirds of the genome of any eukaryotic virus (all virus from a single family being considered identical) may be considered defective and can be used, in the absence of helper, under the conditions specified in III-C.

III-B-3-a. Experiments involving the use of infectious Class 2 animal viruses, or defective Class 2 animal viruses in the presence of helper virus, can be carried out at P2 containment.

III-B-3-b. Experiments involving the use of infectious Class 3 animal viruses, or defective Class 3 animal viruses in the presence of helper virus, can be performed at P3 containment.

III-B-3-c. Experiments involving the use of infectious Class 4 viruses, or defective Class 4 viruses in the presence of helper virus, may be carried out under P4 containment.

III-B-3-d. Experiments involving the use of infectious Class 5 viruses, or defective Class 5 viruses in the presence of helper virus, will be determined on a case-by-case basis following ORDA review. A USDA permit is required for work with Class 5 pathogens.

III-B-3-e. Experiments involving the use of infectious animal or plant viruses, or defective animal or plant viruses in the presence of helper virus, not covered by III-B-3-a, III-B-3-b, III-B-3-c or III-B-3-d may be carried out under P1 containment.

III-B-4. Recombinant DNA experiments involving whole animals or plants.

III-B-4-a. DNA from any source except for greater than two thirds of a eukaryotic viral genome may be transferred to any nonhuman vertebrate organism and propagated under conditions of physical containment comparable to PI and appropriate to the organism under study. It is important that the investigator demonstrate that the fraction of the viral genome being utilized does not lead to productive infection. A USDA permit is required for work with Class 5 agents.

III-B-4-b. For all experiments involving whole animals or plants and not covered by III-B-4-a, the appropriate containment will be determined by the IBC.

III-B-5. Experiments involving more than 10 liters of culture. The appropriate containment will be decided by the IBC. Where appropriate, the large-scale containment recommendations of the NIH should be used (45 FR24968).

III-C. Experiments that require institutional biosafety committee (IBC) notice simultaneously with initiation of experiments. Experiments not included in III-A, III-B, III-D and their subsections are to be considered in III-C. For example, experiments in which all components derive from nonpathogenic prokaryotes and nonpathogenic lower eukaryotes fall under III-C. All such experiments can be carried out at P1 containment. For experiments in this category, a registration document as described in III-B must be dated and signed by the investigator and filed with the local IBC. The IBC shall review all such proposals, but IBC review prior to initiation of the experiment is not required.

Caution: Experiments involving formation of recombinant DNA molecules containing no more than two thirds of the genome of any eukaryotic virus. Recombinant DNA molecules containing no more than two thirds of the genome of any eukaryotic virus (all viruses from a single family being considered identical) may be propagated and maintained in cells in tissue culture using P1 containment. For such experiments, it must be shown that the cells lack helper virus for the specific families of defective viruses being used. If helper virus is present, procedures specified under III-B.3 should be used. The DNA may contain fragments of the genome of viruses from more than one family but each fragment must be less than two thirds of a genome. (It is the responsibility of the institution and those associated with it to adhere to the intent of this Subpart and the NIH guidelines as well as to their specifics.)

III-D. Experiments exempt from the NIH guidelines and specified in section 61-1.3 of this Subpart. As provided in section 61-1.3(c) of this Subpart, an institution may be issued a certificate to engage in recombinant DNA activity limited to recombinant DNA molecules specified in section 61-1.3(c) (class III-D molecules) without being required to comply with the provisions of sections 61-1.30 and 61-1.31 of this Subpart pertaining to the establishment and functioning of an institutional biosafety committee (IBC).

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ROLES AND RESPONSIBILITIES

Section 61-1.30 - Institution; responsibilities

ROLES AND RESP0NSIBILITIES

61-1.30 Institution; responsibilities. Except as otherwise provided by subdivision (c) of section 61-1.3 of this Subpart, the institution shall:

(a) submit to the commissioner a written assurance complying with the requirements of paragraph (2) of subdivision (a) of section 61-1.3 of this Subpart unless it possess a certificate pursuant to subdivision (b) or (d) of said section;

(b) establish an institutional biosafety committee (IBC) that meets the requirements of section 61-1.31 of this Subpart;

(c) ensure that the institutional biosafety committee is fulfilling its responsibilities at all times;

(d) ensure compliance of recombinant DNA activity with the requirements of this Subpart;

(e) if the institution is engaged in recombinant DNA activity at the P3 or P4 containments level, appoint a biological safety officer (BSO), who shall be a member of the IBC and carry out the duties specified in section 61-1.32 of this Subpart;

(f) ensure that all principal investigators (PIs) comply with the provisions of section 61-1.33 of this Subpart;

(g) ensure appropriate training for the IBC chairperson and members, the BSO, principal investigators (PIs), and laboratory staff regarding the requirements of article 32-A of the Public Health Law and this Subpart, their implementation and laboratory safety;

(h) determine, in consultation with the local public health office when appropriate, the necessity and extent of health surveillance of personnel involved in recombinant DNA activity, including, but not limited to records of agents handled, active investigation of illnesses of personnel working with or exposed to recombinant DNA, and maintenance of serial serum samples;

(i) report within 3O days to the commissioner any significant problems with and violations of this Subpart and significant recombinant DNA activity-related accidents and illnesses, unless the institution determines that the PI or IBC has done so; and

(j) upon request, make available to the public any documents submitted to or received from the commissioner which he is required to make available to the public (e.g., reports of violations of this Subpart and of significant recombinant DNA activity-related accidents, and directives to modify projects). If comments are made by members of the public on IBC actions, the institution shall forward to the commissioner both the comments and the IBC's response.

Note: See NIH Laboratory Safety Monograph for additional medical surveillance information.
 

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Section 61-1.31 - Institutional biosafety committee; composition and duties

61-1.31 Institutional biosafety committee; composition and duties.

(a) An institutional biosafety committee (IBC) shall be composed of not less than five persons, approved by the commissioner, who collectively have experience and expertise in recombinant DNA technology and the capability to assess the safety of proposed recombinant DNA activity and any potential risk to public health or the environment. At least two members shall not be affiliated with the institution (apart from their membership on the IBC) and shall represent the interest of the surrounding community with respect to health and protection of the environment. Members meet this requirement if, for example, they are officials of State or local public health or environmental protection agencies, members of other local governmental bodies, or persons active in medical, occupational health, or environmental concerns in the community. The biological safety officer (BSO), mandatory when activity is being conducted at the P3 and P4 levels, shall be a member. The membership should include individuals with expertise in recombinant DNA technology, biological safety and physical containment and include, or have available as consultants, persons knowledgeable in institutional commitments and policies, applicable law, standards of professional conduct and practice, community attitudes and the environment. At least one member should be from the laboratory technical staff. No member of a committee may be involved (except to provide information requested by the IBC) in the review or approval of activity in which he or she has been, or expects to be, engaged, or has a direct or conflicting interest.

(b) IBC meetings and minutes of meetings shall be open to the public, consistent with protection of privacy and proprietary interests.

(c) On behalf of the institution, the IBC shall:

(1) review for compliance with this Subpart all recombinant DNA activity as specified in section 61-1.20 of this Subpart conducted at or sponsored by the institution, and approve those activities that it finds are in conformity with this Subpart. This review shall include:

(i) an independent assessment of the containment levels required by this Subpart for the proposed activity; and

(ii) an assessment of the facilities, procedures and practices, and of the training and expertise of the recombinant DNA personnel;*

(2) notify the principal investigator (PI) of the results of their review;

(3) lower containment levels for certain experiments as specified in section 61-1.20 of this Subpart: class III-B-2;

(4) set containment levels as specified in section 61-1.20 of this Subpart: class III-B-4-b and III-B-5;

(5) review periodically recombinant DNA activity being conducted at the institution, to ensure that the requirements of this Subpart are being fulfilled;

(6) adopt emergency plans covering accidental spills and personnel contamination resulting from such activity;*

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FOOTNOTE: * See NIH Laboratory Safety Monograph for additional details.

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(7) report within 30 days to the appropriate institutional official and to the commissioner any significant problems with or violations of this Subpart, and any significant recombinant DNA activity-related accidents or illnesses, unless the IBC determines that the PI has done so;

(8) maintain appropriate records, including copies of proposals reviewed, minutes of IBC meetings, reports of accidents and illnesses, and records of periodic review;

(9) authorize initiation of no experiment not explicitly covered by this Subpart until NIH establishes the containment requirement; and

(10) perform such other functions as may be delegated to the IBC by the institution consonant with its responsibilities.
 

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Section 61-1.32 - Biological safety officer; duties

61-1.32 Biological safety officer; duties. The institution shall appoint a BSO if it engages in recombinant DNA activity at the P3 or P4 containment level. The officer shall be a member of the institutional biosafety committee (IBC). His or her duties shall include (but need not be limited to):

(a) ensuring through periodic inspections that laboratory standards are rigorously followed;

(b) reporting to the IBC and the institution all significant problems with and violations of this Subpart and all significant recombinant DNA activity-related accidents and illnesses of which the BSO becomes aware, unless the BSO determines that the principal investigator (PI) has done so;

(c) developing emergency plans for dealing with accidental spills and personnel contamination, and investigating recombinant DNA activity laboratory accidents;

(d) providing advice on laboratory security;

(e) providing technical advice to the PI and IBC on recombinant DNA activity safety procedures.

Note: See NIH Laboratory Safety Monograph for additional information on the duties of the BSO.
 

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Section 61-1.33 - Principal investigator; responsibilities

61-1.33 Principal investigator; responsibilities. On behalf of the institution, the PI is responsible for complying fully with this Subpart in conducting any recombinant DNA activity.

(a) PI: general. As part of this general responsibility, the PI shall:

(1) initiate or modify no recombinant DNA activity requiring approval by the IBC prior to initiation (section 61-1.20 of this Subpart: class III-A or III-B) until that activity, or the proposed modification thereof, has been approved by the institutional biosafety committee (IBC) and has met all other requirements of this Subpart;

(2) determine whether recombinant DNA activity is covered by section 61-1.20 of this Subpart: class III-C;

(3) report within 30 days to the IBC and the commissioner all significant problems with and violations of this Subpart and all significant recombinant DNA activity-related accidents and illnesses;

(4) report to the IBC and to the commissioner new information bearing on provisions of this Subpart;

(5) be adequately trained in good microbiological techniques;

(6) adhere to IBC-approved emergency plans for dealing with accidental spills and personnel contamination; and

(7) comply with shipping requirements for recombinant DNA molecules.

(b) Submissions by the PI to NIH. The PI shall:

(1) submit information to NIH (ORDA) in order to have new host-vector systems certified;

(2) petition NIH, with notice to the IBC, for exemptions to the NIH guidelines (see section 61-1.20 of this Subpart: class III-D);

(3) petition NIH, with concurrence of the IBC, for approval to conduct experiments specified in section 61-1.20 of this Subpart: class III-A;

(4) petition NIH for determination of containment for experiments requiring case-by-case review; and

(5) petition NIH for determination of containment for experiments not covered by this Subpart or the NIH guidelines.

(c) Submissions by the PI to the IBC. The PI shall:

(1) make the initial determination of the required levels of physical and biological containment in accordance with this Subpart or the NIH guidelines;

(2) select appropriate microbiological practices and laboratory techniques to be used in the recombinant DNA activity;

(3) submit the initial recombinant DNA activity protocol if covered under section 61-1.20 of this Subpart: class III-A, III-B or III-C (and also subsequent changes--e.g., changes in the source of DNA or host-vector system) to the IBC for review and approval or disapproval; and

(4) remain in communication with the IBC throughout the conduct of the recombinant DNA activity.

(d) PI responsibilities prior to initiating the activity. The PI is responsible for:

(1) making available to the laboratory staff copies of the protocols that describe the potential biohazards and the precautions to be taken;

(2) instructing and training staff in the practices and techniques required to ensure safety and in the procedures for dealing with accidents; and

(3) informing the staff of the reasons and provisions for any precautionary medical practices advised or requested, such as vaccinations or serum collection.

(e) PI responsibilities during the conduct of the activity. The PI is responsible for:

(1) supervising the safety performance of the staff to ensure that the required safety practices and techniques are employed;

(2) investigating and reporting in writing to the commissioner, the biological safety officer (where applicable) and the IBC any significant problems pertaining to the operation and implementation of containment practices and procedures;

(3) correcting work errors and conditions that may result in the release of recombinant DNA materials; and

(4) ensuring the integrity of the physical containment (e.g., biological safety cabinets) and the biological containment (e.g., purity, and genotypic and phenotypic characteristics).
 

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Section 61-1.34 - Personnel; training and qualifications

61-1.34 Personnel; training and qualifications. The PI shall be responsible for providing instruction and training in microbiological procedures and techniques to ensure safe work conditions and awareness of procedures for dealing with accidents. Outlines for imparting knowledge appropriate for recombinant DNA activity shall be provided by the IBC consistent with recommendations made by NIH. Unless inconsistent with such recommendations, all laboratory workers and other personnel with duties in recombinant DNA activity facilities shall receive training to include, as appropriate, the following:

(a) governmental and institutional requirements respecting biohazardous research;

(b) an explanation of the recombinant DNA activity engaged in, including organisms and degree of hazard;

(c) general safety measures, including required containment levels, use and disposal of protective clothing, handling techniques, disposal of wastes and decontamination of wastes, clothing and work surfaces;

(d) spill contamination notification procedures;

(e) identification of chemicals employed in the recombinant DNA activity and in decontamination, including possible hazards; and

(f) a description of health monitoring procedures, including frequency of physicals, nature of tests and symptoms, and filing and confidentiality of health records.
 

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Section 61-1.35 - Personnel; health monitoring programs

61-1.35 Personnel; health monitoring programs. The institution and the PI shall be responsible for determining, in connection with each recombinant DNA activity, medical surveillance of all personnel with duties in recombinant DNA activity facilities before, during, and after their involvement in the activity, including, as appropriate, a serum collection program, periodic examinations, immunizations, reporting and investigating accidents and illnesses and medical evaluation.

 

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Section 61-1.36 - Confidentiality of information

61-1.36 Confidentiality of information.

(a) Proprietary information submitted to NIH in connection with the approval procedures set forth in part VI, Voluntary Compliance, of the NIH Guidelines, as required for certification pursuant to subdivision (d) of section 61-1.3 of this Subpart, will be protected by NIH as provided in part VI of the NIH Guidelines.

(b) Proprietary information submitted to the commissioner will be protected as follows:

(1) An institution may designate those items of information in applications, statements or reports to the commissioner or the department made pursuant to this Subpart, not protected by patent or copyright, which the institution believes are trade secrets or are maintained for the regulation of commercial enterprise which if disclosed would cause substantial injury to the competitive position of the subject enterprise.

(2) If the department receives a request under the Freedom of Information Law for information so designated, it will promptly contact the institution to secure its views as to whether the information (or some portion) should be released.

(3) If the department decides to release the information (or some portion) in response to a Freedom of Information Law request or otherwise, the institution will be advised, and the release will not be made until the expiration of 15 business days after receipt of the request, except to the extent that earlier release in the judgment of the commissioner is necessary to protect against an imminent hazard to the public or the environment.
 

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Section 61-1.37 - Complaints

61-1.37 Complaints. Information concerning noncompliance with a requirement of this Subpart may be brought forward by any person. Copies of the complaint shall be delivered to the institution concerned and to the commissioner. The institution shall cause the complaint to be investigated and report the results of its investigation and any action thereon promptly to the commissioner. Such further action as the commissioner shall deem appropriate shall be taken by the institution or the commissioner or both, including enforcement action authorized under section 3223 of the Public Health Law and withdrawal of approval of the institutional biosafety committee.

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