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What is NYC RCNY § 13.01?

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When used in this article: (a) "Laboratory" or "clinical laboratory" means a facility, including a blood bank, regulated pursuant to Title 5 of Article 5 of the Public Health Law holding a permit issued by the New York State Department of Health, and operating in the City or testing a specimen taken from a City reside

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Effective: 12/12/2016Last amended: 12/12/2016

§ 13.01 Definitions.

RCNY § 13.01

When used in this article: (a) "Laboratory" or "clinical laboratory" means a facility, including a blood bank, regulated pursuant to Title 5 of Article 5 of the Public Health Law holding a permit issued by the New York State Department of Health, and operating in the City or testing a specimen taken from a City resident.

(b)"Research laboratory" means a laboratory used primarily for research, development, storage, examination or testing of one or more biological agents by or under the direct supervision of a technically qualified individual, but does not include: (i) clinical laboratories and blood banks holding permits issued pursuant to Title 5 of Article 5 of the Public Health Law; (ii) laboratories where recombinant DNA experiments are conducted pursuant to Article 32-A of the Public Health Law; (iii) tissue or organ banks holding permits issued pursuant to Article 43-B of the Public Health Law; and (iv) laboratory facilities operated by New York State or federal governments.

(c)"Biological agent" means an infectious microorganism or hazardous biological material, such as a bacterium, virus, fungus, parasite, or biological toxin that is associated with human disease.

(d)"High-containment research laboratory" means any research laboratory that operates at biosafety level 3 or biosafety level 4, as defined by the Centers for Disease Control and Prevention and National Institutes for Health in Biosafety in Microbiological and Biomedical Laboratories, or successor document available at http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf.

(e)"High-risk agent" means Middle East respiratory coronavirus (MERS-CoV), all Mycobacterium tuberculosis strains and any other biological agent that the Commissioner, upon notice, determines would be a severe risk to public health if released into the environment and could result in severe morbidity or high mortality.

(f)"Select agent" means a biological agent or toxin listed in 42 C.F.R. §§ 73.3 or 73.4 or 9 C.F.R. § 121.4, or any successor provisions, which requires laboratories that possess, use or transfer such agent to register with the Federal Select Agent Program, as described in 42 C.F.R. Part 73, 9 C.F.R. Part 121 and 7 C.F.R. Part 331.

(g)"Exposure" means the ingestion, inhalation, inoculation, or contamination of skin or mucous membranes with a biological agent. (Amended City Record 6/15/2016, eff. 12/12/2016)

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