New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 55 - APPROVAL OF LABORATORIES › Subpart 55-2 - APPROVAL OF LABORATORIES PERFORMING ENVIRONMENTAL ANALYSIS › Section 55-2.13 - Requirements for laboratories engaged in testing for critical agents in environmental samples

Current through Register Vol. 46, No. 28, July 10, 2024
(a) For
					 purposes of this Subpart, critical agent shall mean an organism, chemical
					 element or chemical compound, which is recognized as posing a risk to national
					 security and/or requiring special action to protect the public health because
					 the agent: can be disseminated (e.g., in air, water or food) or transmitted
					 person-to-person with ease; causes moderate to high mortality and/or morbidity;
					 and can have a significant public health impact. The term organism includes,
					 but is not limited to, a virus, bacterium, or product or component of an
					 organism (e.g., a toxin). Critical agents shall include critical biological and
					 chemical agents, including select agents, specified by the Federal Centers for
					 Disease Control and Prevention (CDC) in published documents, and other such
					 agents as the Commissioner of Health has determined meet the above criteria.
					 The terms chemical element and chemical compound include substances that emit
					 ionizing radiation including alpha, beta, gamma or neutron radiation.
(b)
(1)
					 Prior to performing testing for any critical agent in an environmental sample,
					 a laboratory shall submit a request to the department, and receive an initial
					 or revised certificate of approval that includes the specialty of critical
					 agent testing and the approved method(s) the laboratory is authorized to employ
					 as stipulated in sections
					 55-2.1 and
					 55-2.5 
					 of this Subpart. The certificate of approval shall also list the specific
					 critical agent(s) included in the approval, the approved method(s), and the
					 types of samples (e.g., surface swipes, powder, air, fluid and bulk material)
					 the laboratory may accept for testing. No laboratory shall examine an
					 environmental sample for a critical biological agent or critical chemical agent
					 without certification of approval specific to each critical agent for which
					 testing is conducted.
(2) The
					 department may withhold or limit its approval if the department is not
					 satisfied that the laboratory has in place adequate policies, procedures,
					 facilities, equipment, instrumentation; and trained personnel to ensure that:
					 collection; labeling; accessioning; preparation; analysis' result reporting or,
					 for an autonomous detection system as defined in section
					 55-2.14(a) 
					 of this Subpart, responding to a signal indicating the presence of a critical
					 agent; storage; transportation; shipping; and disposition of all environmental
					 samples, derivatives and related materials shall be performed in a manner that:
					 ensures consistently correct performance of the approved methods; ensures the
					 protection of the health, safety and welfare of the laboratory's employees and
					 the public; and is consistent with the requirements of this Subpart, and all
					 other applicable laws, rules and regulations. The department shall also
					 consider a laboratory's biosafety level facilities, safety practices, and its
					 capability to assume an appropriate role in the public health and safety
					 response(s) to critical agents, in its determination to approve the laboratory
					 for critical agent testing in environmental samples.