Loading...
(a) Registration. Every person operating a high-containment research laboratory in the City of New York must register such laboratory with the Department. Registrations will expire and must be renewed every three years. An entity or person registering with the Department must provide all the information requested by the Department on the registration form, including but not limited to:
(1) Name, address and other contact information for the officers or persons in control of the operating entity;
(2) Locations and biosafety level rating or ratings for each research laboratory operated by the registering entity;
(3) Name, title and contact information of at least two designated persons who are individuals at the research laboratory designated to submit to the Department the reports required by 24 RCNY Health Code § 13.13, provided that one such designated person is the manager or other person in control of the research laboratory biosafety committee; and
(4) A listing of all biological agents stored or used in each high-containment research laboratory at the time of registration. The listing must include the parent strain of the agent and any derivative strains identified by the high-containment research laboratory as having unique virulence or pathogenic potential.
(b) New facilities. Any person intending to operate a new high-containment research laboratory must register such laboratory according to this section before such laboratory commences operation.
(c) Changes in registration information. The registrant must notify the Department within thirty (30) calendar days of any changes to the information provided on the registration form that pertains to any select agent or high-risk agent.
(Added City Record 6/15/2016, eff. 12/12/2016)
(a) Loss or theft of a biological agent. No later than four hours after determining that there has been a theft or loss of a biological agent from a high-containment research laboratory, the laboratory operator or a person designated on the registration form of such laboratory must notify the Department of such theft or loss at a telephone number designated by the Department. Any theft or loss must be reported even if the lost or stolen biological agent is subsequently recovered and/or the responsible parties are identified. The following information must be provided:
(1) The name of the biological agent and any and all of its identifying information (e.g., strain or other characterization information);
(2) The quantity or an estimate of the quantity of the biological agent that was lost or stolen;
(3) The time or an estimate of the time during which the theft or loss occurred;
(4) The location (building, room) from which the theft or loss occurred.
(b) Exposure to or unintentional release of biological agents. Within one hour of determining that a person may have been exposed to a biological agent stored or used in a high-containment research laboratory, or of any unintentional release of a biological agent, or of an illness associated with exposure to a biological agent used or stored in a high-containment research laboratory, the laboratory operator or a person designated on the registration form of such laboratory must notify the Department of the actual or potential exposure at a telephone number designated by the Department. The following information must be provided:
(1) The name of the biological agent and any and all of its identifying information (e.g., strain or other characterization information);
(2) An estimate of the number of persons potentially exposed to the biological agent in or by the research laboratory and within the entity;
(3) An estimate of the quantity of biological agent that was released;
(4) An estimate of the time and duration of the release of the biological agent;
(5) The environment into which the biological agent was released (e.g., within vs. outside building, into a waste system);
(6) The location (building, room) from which the release of the biological agent occurred;
(7) Identification and contact information for all persons known to be exposed to the biological agent;
(8) Actions taken to respond to the release of the biological agent; and
(9) Hazards posed by the release of the biological agent.
(c) No requirement of this section affects any other obligation under any other law or regulation for a high-containment laboratory to report the loss, theft or release of a biological agent to any other law enforcement or regulatory agency.
(d) All information, records and reports required by this section shall be kept confidential, provided that the Commissioner may disclose to a city, state or federal agency information necessary to respond to an emergency after determining such an emergency exists.
(Added City Record 6/15/2016, eff. 12/12/2016)
(a) No person other than a licensed physician, dentist or veterinarian or a person under the direct supervision of a licensed physician, dentist or veterinarian shall possess or cultivate pathogens without a permit issued by the Commissioner. A permit shall not be issued unless the applicant's education, experience and moral character are satisfactory to the Commissioner, and unless the Commissioner is satisfied that the pathogens in the possession of the applicant will not endanger public health. The fee for and the expiration date of such a permit shall be as prescribed by 24 RCNY Health Code § 5.07. However, no permit shall be required under this subsection where the person possessing or cultivating pathogens at a given location is the holder of a New York State Department of Health permit to maintain or operate a clinical laboratory at the same location, which permit qualifies the permittee to perform tests in microbiology including the subspecialities of bacteriology, mycobacteriology, virology, mycology and parasitology pursuant to the New York State Public Health Law and regulations promulgated thereunder.
(b) A person, other than a licensed physician, dentist or veterinarian or a person under the direct supervision of a licensed physician, dentist or veterinarian, in charge of a place where pathogens are handled or cultivated shall register such place with the Department. A pathogen permit issued in accordance with subsection (a) of this section shall constitute such registration. No registration is required where the person possessing or cultivating pathogens at a given location is the holder of a New York State Department of Health permit to maintain or operate a clinical laboratory at the same location, which permit qualifies the permittee to perform tests in microbiology.
(c) This article shall not apply to a laboratory maintained by the City, State, government of the United States or by any county within the State.
(a) No person shall sell, give away or convey pathogens to any other person without the permission of the Commissioner. Every container of pathogens sold, given away or conveyed shall bear a label stating the contents of the container, the name, address and registration number of the distributor and the name, address and registration number of the recipient.
(b) This section does not apply to diseased tissue, exudate or other specimens sent to a laboratory for tests to obtain information for diagnosis, prophylaxis or treatment by a licensed physician, veterinarian or other person authorized by law to use the results of such tests in his practice.
Loading...