Section 55-2.1 - Definitions

55-2.1 Definitions. For purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings:

(a) Environmental laboratory means any facility that examines, or is available for the examination of, samples or specimens, including, but not limited to: air, stack emissions, water, wastewater, surface water, ground water, recreational waters, swimming pools, leachate, land runoff, solid waste, hazardous waste, soil, sediments and vegetation, as well as any substance that could contribute to the pollution of or that could be contaminated by material contained in such samples or specimens. Such examinations shall be limited to qualitative or quantitative determinations of the biological, chemical, radiochemical or physical characteristics of such samples or specimens for the purposes of public or personal health protection, or the protection of the environment or natural resources. Environmental laboratories shall not include facilities or entities that perform non-laboratory chemical testing associated with residential water softeners and residential swimming pools. Environmental laboratories shall include mobile laboratories, as defined in subdivision (c) of this section. (b) Approved laboratory means an environmental laboratory that has demonstrated to the New York State Commissioner of Health that it has met the on-site assessment, technical direction and proficiency testing requirements of this Subpart, and therefore has been issued a certificate of approval. For purposes of this Subpart, accredited shall have the same meaning as approved.
(c) Mobile laboratory means a separate, self-contained mobile facility for the examination of environmental samples or specimens as described in subdivision (a) of this section. A mobile laboratory shall have a fixed address, provided to the department with each application for approval, to which proficiency test samples and other correspondence may be sent, and shall be managed by a responsible person authorized to receive service of process.

(d) Technical director means an individual responsible for the technical and scientific operation of an environmental laboratory,and who meets the minimum qualifications in section 55-2.10 of this Subpart. If an environmental laboratory employs more than one technical director, the laboratory owner(s) shall designate one such individual as the lead technical director.

(e) Approved method means an analytical method, including sample preparation, of proven reliability which has been approved, or given similar recognition by the United States Environmental Protection Agency (EPA) or a New York State regulatory program in environmental or public health protection, for the specific purpose for which the method is to be used. Methods approved by the department pursuant to section 55-2.5 of this Subpart shall be deemed approved methods. The department shall make available a list of approved methods to approved laboratories. (f) Quality system means a structured laboratory management system that meets the standards for a quality system as set forth in the department’s Environmental Laboratory Approval Program Quality System Standards 2002, July 1, 2002 revision, which is hereby incorporated by reference, with the same force and effect as if fully set forth herein. These standards are available for public inspection and copying at the New York State Department of Health, Records Access Office, Corning Tower, Empire State Plaza, Albany, New York 12237.

(g) Analyte means a chemical and/or physical property, element, compound, group of compounds, organism or group of organisms, to be determined in samples examined. Sample and specimen are synonymous terms, and are used interchangeably in this Subpart.

(h) Statistical mean means the arithmetic average of a data set after outlier rejection, or, if transformation is used, the central point of data set distribution after outlier rejection.

(i) Method detection limit means the minimum concentration of an analyte that can be measured and reported with 99-percent confidence that the analyte concentration is greater than zero, as defined or stated in the least sensitive approved method.

(j) Assigned value means the nominal concentration of an analyte, based on sample preparation.

(k) Relative standard deviation means the standard deviation of a data set divided by the statistical mean, expressed as a percentage. Predictive standard deviation means the standard deviation derived from a linear regression equation based on historical data.

(l) Synthetic blank means an artificial sample with contents of known purity and without added analytes.

(m) Natural blank means a sample derived from the environment, for which the concentration of a given analyte or analytes, after repeated analyses, has been determined to be below the method detection limit.

(n) Spiked sample means a sample to which a known amount of an analyte has been added.

(o) Natural sample means a sample collected from the environment, to which no analytes have been added.

(p) Contract Laboratory Protocol (CLP) means a protocol, issued by the New York State Department of Environmental Conservation, for performance of environmental analyses in accordance with specifications describing: the types of samples to be analyzed (such as soil or water); internal sample-handling procedures (such as chain-of-custody or holding times); instrumentation and method of analysis to be used for each analyte; calibration procedures to be implemented (such as numbers of standards, their concentrations and acceptance criteria); quality control samples to be analyzed and the frequency of such analysis; and organization and content of reports to be issued on analytical results obtained.

(q) CLP data package means a collection of documentation whose organization and content are specified by CLPs. A CLP data package shall consist of analytical reports, including, but not limited to, a narrative description of how the analysis was performed, any problems encountered, analytical results for all samples, results for all quality control samples analyzed, copies of instrument printouts, and all logbook pages and laboratory bench sheets.

(r) Department means the New York State Department of Health. (s) Denial means the department’s refusal to approve, in total or in part, an environmental laboratory’s application for approval, including resubmission of an initial or renewal application. (t) Suspension means the department’s temporary removal, in total or in part, of an environmental laboratory’s approval for a defined period of time not exceeding six (6) months, to allow such laboratory time to correct deficiencies or areas of non-compliance. (u) Revocation means the department’s withdrawal, in total or in part, of an environmental laboratory’s approval.

Effective Date: 
Wednesday, November 17, 2004
Doc Status: 
Complete