Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 46 - ACCREDITATION FOR COMMERCIAL ENVIRONMENTAL LABORATORIES › Part I - General Provisions › Section 1VAC30-46-40 - Definitions

Current through Register Vol. 40, No. 24, July 15, 2024
A. The definitions
				  contained in the 2016 TNI Standards are incorporated by reference into this
				  section. Some of these definitions are included in this section because the
				  terms are used throughout this chapter.
B. The following words and terms when used in
				  this chapter shall have the following meanings unless the context clearly
				  indicates otherwise:
"Acceptance criteria" means specified limits placed on
					 characteristics of an item, process, or service defined in requirement
					 documents.
"Accreditation" means the process by which an agency or
					 organization evaluates and recognizes a laboratory as meeting certain
					 predetermined qualifications or standards, thereby accrediting the laboratory.
					 "Accreditation" is the term used as a substitute for the term "certification"
					 under this chapter.
"Accreditation body" or "AB" means the territorial, state,
					 or federal agency having responsibility and accountability for environmental
					 laboratory accreditation and which grants accreditation.
"Algae" means simple single-celled, colonial, or
					 multicelled, mostly aquatic plants, containing chlorophyll and lacking roots,
					 stems and leaves that are either suspended in water (phytoplankton) or attached
					 to rocks and other substrates (periphyton).
"Analyte" means the substance, organism, physical
					 parameter, or chemical constituent for which an environmental sample is being
					 analyzed.
"Analytical method" means a technical procedure for
					 providing analysis of a sample, defined by a body such as the Environmental
					 Protection Agency or the American Society for Testing and Materials, that may
					 not include the sample preparation method.
"Assessment" means the evaluation process used to measure
					 or establish the performance, effectiveness, and conformance of an organization
					 and its systems or both to defined criteria (i.e., to the standards and
					 requirements of laboratory accreditation).
"Assessor" means the person assigned by DCLS to perform,
					 alone or as part of an assessment team, an assessment of an environmental
					 laboratory.
"Authority" means, in the context of a governmental body or
					 local government, an authority created under the provisions of the Virginia
					 Water and Waste Authorities Act, Chapter 51 (§ 15.2-5100 et seq.) of Title 15.2
					 of the Code of Virginia.
"Benthic macroinvertebrates" means bottom dwelling animals
					 without backbones that live at least part of their life cycles within or upon
					 available substrates within a body of water.
"Commercial environmental laboratory" means an
					 environmental laboratory where environmental analysis is performed for another
					 person.
"Corrective action" means the action taken to eliminate the
					 causes of an existing nonconformity, defect or other undesirable situation in
					 order to prevent recurrence.
"DCLS" means the Division of Consolidated Laboratory
					 Services of the Department of General Services.
"Environmental analysis" or "environmental analyses" means
					 any test, analysis, measurement, or monitoring used for the purposes of the
					 Virginia Air Pollution Control Law, the Virginia Waste Management Act or the
					 State Water Control Law (§ 10.1-1300 et seq., § 10.1-1400 et seq., and §
					 62.1-44.2 et seq., respectively, of the Code of Virginia). For the purposes of
					 these regulations, any test, analysis, measurement, or monitoring required
					 pursuant to the regulations promulgated under these three laws, or by any
					 permit or order issued under the authority of any of these laws or regulations
					 is "used for the purposes" of these laws. The term shall not include the
					 following:
1. Sampling of water, solid
				  and chemical materials, biological tissue, or air and emissions.
2. Field testing and measurement of water,
				  solid and chemical materials, biological tissue, or air and emissions, except
				  when performed in an environmental laboratory rather than at the site where the
				  sample was taken.
3. Taxonomic
				  identification of samples for which there is no national accreditation standard
				  such as algae, benthic macroinvertebrates, macrophytes, vertebrates, and
				  zooplankton.
4. Protocols used
				  pursuant to § 10.1-104.2 of the Code of Virginia to determine soil fertility,
				  animal manure nutrient content, or plant tissue nutrient uptake for the
				  purposes of nutrient management.
5.
				  Geochemical and permeability testing for solid waste compliance.
6. Materials specification for air quality
				  compliance when product certifications specify the data required by an air
				  permit such as fuel type, Btu content, sulfur content, or volatile organic
				  chemical (VOC) content.
"Environmental laboratory" or "laboratory" means a facility
					 or a defined area within a facility where environmental analysis is performed.
					 A structure built solely to shelter field personnel and equipment from
					 inclement weather shall not be considered an environmental laboratory.
"Establishment date" means the date set for the
					 accreditation program under this chapter and the certification program under
					 1VAC30-45 to be established.
"Establishment of accreditation program" or "established
					 program" means that DCLS has completed the initial accreditation of
					 environmental laboratories covered by this chapter and the initial
					 certification of environmental laboratories covered by 1VAC30-45.
"Facility" means something that is built or installed to
					 serve a particular function.
"Field of accreditation" means those matrix,
					 technology/method, and analyte combinations for which DCLS offers
					 accreditation.
"Field of accreditation matrix" means the following when
					 accrediting a laboratory:
1. Drinking
				  water. Any aqueous sample that has been designated a potable or potential
				  potable water source.
2. Nonpotable
				  water. Any aqueous sample excluded from the definition of drinking water
				  matrix. Includes surface water, groundwater, effluents, water treatment
				  chemicals, and TCLP or other extracts.
3. Solid and chemical materials. Includes
				  soils, sediments, sludges, products and byproducts of an industrial process
				  that results in a matrix not previously defined.
4. Biological tissue. Any sample of a
				  biological origin such as fish tissue, shellfish, or plant material. Such
				  samples shall be grouped according to origin (i.e., by species).
5. Air and emissions. Whole gas or vapor
				  samples including those contained in flexible or rigid wall containers and the
				  extracted concentrated analytes of interest from a gas or vapor that are
				  collected with a sorbent tube, impinger solution, filter or other device.
"Field of proficiency testing" or "FoPT" means the matrix,
					 technology/method, and analyte combinations for which the composition spike
					 concentration ranges and acceptance criteria have been established by the
					 Proficiency Testing Program Executive Committee of TNI.
"Field testing and measurement" means any of the
					 following:
1. Any test for parameters
				  under 40 CFR Part 136 for which the holding time indicated for the sample
				  requires immediate analysis; or
2.
				  Any test defined as a field test in federal regulation.
The following is a limited list of currently recognized
					 field tests or measures that is not intended to be inclusive: continuous
					 emissions monitoring; online monitoring; flow monitoring; tests for pH,
					 residual chlorine, temperature and dissolved oxygen; and field analysis for
					 soil gas.
"Finding" means an assessment conclusion referenced to a
					 laboratory accreditation standard incorporated by reference or contained in
					 this chapter and supported by objective evidence that identifies a deviation
					 from a laboratory accreditation standard requirement.
"Governmental body" means any department, agency, bureau,
					 authority, or district of the United States government, of the government of
					 the Commonwealth of Virginia, or of any local government within the
					 Commonwealth of Virginia.
"Holding time" means the maximum time that can elapse
					 between two specified activities.
"Legal entity" means an entity, other than a natural
					 person, who has sufficient existence in legal contemplation that it can
					 function legally, be sued or sue and make decisions through agents as in the
					 case of corporations.
"Local government" means a municipality (city or town),
					 county, sanitation district, or authority.
"Macrophytes" means any aquatic or terrestrial plant
					 species that can be identified and observed with the eye, unaided by
					 magnification.
"Matrix" means the substrate of a test sample.
"National Environmental Laboratory Accreditation Conference
					 " or "NELAC" means a voluntary organization of state and federal environmental
					 officials and interest groups with the primary purpose to establish mutually
					 acceptable standards for accrediting environmental laboratories. NELAC preceded
					 the formation of The NELAC Institute or TNI.
"National Environmental Laboratory Accreditation Program"
					 or "NELAP" means the program under TNI the purpose of which is to establish and
					 implement a program for the accreditation of environmental laboratories. This
					 program is comprised in part of NELAP Accreditation Bodies which are recognized
					 and approved under the program to implement the TNI standards. The NELAP
					 accreditation bodies currently are state programs such as the one in
					 Virginia.
"Noncommercial environmental laboratory" means either of
					 the following:
1. An environmental
				  laboratory where environmental analysis is performed solely for the owner of
				  the laboratory.
2. An environmental
				  laboratory where the only performance of environmental analysis for another
				  person is one of the following:
a.
				  Environmental analysis performed by an environmental laboratory owned by a
				  local government for an owner of a small wastewater treatment system treating
				  domestic sewage at a flow rate of less than or equal to 1,000 gallons per
				  day.
b. Environmental analysis
				  performed by an environmental laboratory operated by a corporation as part of a
				  general contract issued by a local government to operate and maintain a
				  wastewater treatment system or a waterworks.
c. Environmental analysis performed by an
				  environmental laboratory owned by a corporation as part of the prequalification
				  process or to confirm the identity or characteristics of material supplied by a
				  potential or existing customer or generator as required by a hazardous waste
				  management permit under 9VAC20-60.
d. Environmental analysis performed by an
				  environmental laboratory owned by a Publicly Owned Treatment Works (POTW) for
				  an industrial source of wastewater under a permit issued by the POTW to the
				  industrial source as part of the requirements of a pretreatment program under
				  Part VII (9VAC25-31-730
				  et seq.) of 9VAC25-31.
e.
				  Environmental analysis performed by an environmental laboratory owned by a
				  county authority for any municipality within the county's geographic
				  jurisdiction when the environmental analysis pertains solely to the purpose for
				  which the authority was created.
f.
				  Environmental analysis performed by an environmental laboratory owned by an
				  authority or a sanitation district for any participating local government of
				  the authority or sanitation district when the environmental analysis pertains
				  solely to the purpose for which the authority or sanitation district was
				  created.
"Owner" means any person who owns, operates, leases, or
					 controls an environmental laboratory.
"Person" means an individual, corporation, partnership,
					 association, company, business, trust, joint venture or other legal
					 entity.
"Physical," for the purposes of fee test categories, means
					 the tests to determine the physical properties of a sample. Tests for solids,
					 turbidity, and color are examples of physical tests.
"Pretreatment requirements" means any requirements arising
					 under Part VII (9VAC25-31-730
					 et seq.) of 9VAC25-31 including the duty to allow or carry out inspections,
					 entry, or monitoring activities; any rules, regulations, or orders issued by
					 the owner of a POTW; or any reporting requirements imposed by the owner of a
					 POTW or by the regulations of the State Water Control Board. Pretreatment
					 requirements do not include the requirements of a national pretreatment
					 standard.
"Primary accreditation body" or "primary AB" means the
					 accreditation body responsible for assessing a laboratory's total quality
					 system, on-site assessment, and PT performance tracking for fields of
					 accreditation.
"Proficiency test," "proficiency testing," or "PT" means a
					 process to evaluate a laboratory's performance under controlled conditions
					 relative to a given set of criteria through analysis of unknown samples
					 provided by an external source.
"Proficiency test sample" or "PT sample" means a sample,
					 the composition of which is unknown to the laboratory and is provided to test
					 whether the laboratory can produce analytical results within specified
					 acceptance criteria.
"Proficiency testing program" or "PT program" means the
					 aggregate of providing rigorously controlled and standardized environmental
					 samples to a laboratory for analysis, reporting of results, statistical
					 evaluation of the results and the collective demographics and results summary
					 of all participating laboratories.
"Publicly Owned Treatment Works" or "POTW" means a
					 treatment works as defined by § 212 of the CWA, which is owned by a state or
					 municipality (as defined by § 502(4) of the CWA). This definition includes any
					 devices and systems used in the storage, treatment, recycling, and reclamation
					 of municipal sewage or industrial wastes of a liquid nature. It also includes
					 sewers, pipes, and other conveyances only if they convey wastewater to a POTW
					 treatment plant. The term also means the municipality as defined in § 502(4) of
					 the CWA, which has jurisdiction over the indirect discharges to and the
					 discharges from such a treatment works.
"Quality assurance" or "QA" means an integrated system of
					 management activities involving planning, implementation, assessment,
					 reporting, and quality improvement to ensure that a process, item, or service
					 is of the type and quality needed and expected by the client.
"Quality assurance officer" means the person who has
					 responsibility for the quality system and its implementation. Where staffing is
					 limited, the quality assurance officer may also be the technical
					 manager.
"Quality control" or "QC" means the (i) overall system of
					 technical activities that measures the attributes and performance of a process,
					 item, or service against defined standards to verify that they meet the stated
					 requirements established by the customer; (ii) operational techniques and
					 activities that are used to fulfill requirements for quality; and (iii) system
					 of activities and checks used to ensure that measurement systems are maintained
					 within prescribed limits, providing protection against "out of control"
					 conditions and ensuring that the results are of acceptable quality.
"Quality manual" means a document stating the management
					 policies, objectives, principles, organizational structure and authority,
					 responsibilities, accountability, and implementation of an agency,
					 organization, or laboratory, to ensure the quality of its product and the
					 utility of its product to its users.
"Quality system" means a structured and documented
					 management system describing the policies, objectives, principles,
					 organizational authority, responsibilities, accountability, and implementation
					 plan of an organization for ensuring quality in its work processes, products
					 (items), and services. The quality system provides the framework for planning,
					 implementing, and assessing work performed by the organization and for carrying
					 out required quality assurance and quality control activities.
"Responsible official" means one of the following, as
					 appropriate:
1. If the laboratory is
				  owned or operated by a private corporation, "responsible official" means
(i) a president, secretary, treasurer, or a
				  vice-president of the corporation in charge of a principal business function,
				  or any other person who performs similar policy-making or decision-making
				  functions for the corporation or
(ii) the manager of one or more
				  manufacturing, production, or operating facilities employing more than 250
				  persons or having gross annual sales or expenditures exceeding $25 million (in
				  second-quarter 1980 dollars), if authority to sign documents has been assigned
				  or delegated in accordance with corporate procedures.
2. If the laboratory is owned or operated by
				  a partnership, association, or a sole proprietor, "responsible official" means
				  a general partner, officer of the association, or the proprietor,
				  respectively.
3. If the laboratory
				  is owned or operated by a governmental body, "responsible official" means a
				  director or highest official appointed or designated to oversee the operation
				  and performance of the activities of the governmental laboratory.
4. Any person designated as the responsible
				  official by an individual described in subdivision 1, 2, or 3 of this
				  definition provided the designation is in writing, the designation specifies an
				  individual or position with responsibility for the overall operation of the
				  laboratory, and the designation is submitted to DCLS.
"Sampling" means an activity related to obtaining a
					 representative sample of the object of conformity assessment, according to a
					 procedure.
"Sanitation district" means a sanitation district created
					 under the provisions of Chapters 3 (§ 21-141 et seq.) through 5 (§ 21-291 et
					 seq.) of Title 21 of the Code of Virginia.
"Secondary accreditation body" or "secondary AB" means the
					 accreditation body that grants laboratory accreditation for a field of
					 accreditation based on recognition of accreditation from a primary
					 accreditation body for the same field of accreditation.
"Sewage" means the water-carried human wastes from
					 residences, buildings, industrial establishments, or other places together with
					 such industrial wastes and underground, surface, storm, or other water as may
					 be present.
"Standard operating procedure" or "SOP" means a written
					 document that details the method for an operation, analysis, or action with
					 thoroughly prescribed techniques and steps. An SOP is officially approved as
					 the method for performing certain routine or repetitive tasks.
"TCLP" or "toxicity characteristic leachate procedure"
					 means Test Method 1311 in "Test Methods for Evaluating Solid Waste,
					 Physical/Chemical Methods," EPA Publication SW-846, as incorporated by
					 reference in
					 40 CFR
					 260.11. This method is used to determine
					 whether a solid waste exhibits the characteristic of toxicity (see
					 40 CFR
					 261.24) .
"Technical manager (however named)" means the person who
					 has overall responsibility for the technical operation of the environmental
					 laboratory and who exercises actual day-to-day supervision of laboratory
					 operation for the appropriate fields of testing and reporting of results. The
					 title of this person may include but is not limited to laboratory director,
					 technical manager, laboratory supervisor, or laboratory manager.
"Technology" means a specific arrangement of analytical
					 instruments, detection systems, or preparation techniques, or any combination
					 of these elements.
"Test" means a technical operation that consists of the
					 determination of one or more characteristics or performance of a given product,
					 material, equipment, organism, physical phenomenon, process, or service
					 according to a specified procedure.
"Test, analysis, measurement or monitoring required
					 pursuant to the Virginia Air Pollution Control Law" means any method of
					 analysis required by the Virginia Air Pollution Control Law (§ 10.1-1300 et
					 seq. of the Code of Virginia); by the regulations promulgated under this law
					 (9VAC5), including any method of analysis listed either in the definition of
					 "reference method" in
					 9VAC5-10-20, or
					 listed or adopted by reference in 9VAC5; or by any permit or order issued under
					 and in accordance with this law and these regulations.
"Test, analysis, measurement or monitoring required
					 pursuant to the Virginia Waste Management Act" means any method of analysis
					 required by the Virginia Waste Management Act (§ 10.1-1400 et seq. of the Code
					 of Virginia); by the regulations promulgated under this law (9VAC20), including
					 any method of analysis listed or adopted by reference in 9VAC20; or by any
					 permit or order issued under and in accordance with this law and these
					 regulations.
"Test, analysis, measurement or monitoring required
					 pursuant to the Virginia Water Control Law" means any method of analysis
					 required by the Virginia Water Control Law (§ 62.1-44.2 et seq. of the Code of
					 Virginia); by the regulations promulgated under this law (9VAC25), including
					 any method of analysis listed or adopted by reference in 9VAC25; or by any
					 permit or order issued under and in accordance with this law and these
					 regulations.
"Test method" means an adoption of a scientific technique
					 for performing a specific measurement, as documented in a laboratory standard
					 operating procedure or as published by a recognized authority.
"The NELAC Institute " or "TNI" means the organization
					 whose standards environmental laboratories must meet to be accredited in
					 Virginia.
"TNI standards" means the 2016 Standards for Environmental
					 Laboratories and Accreditation Bodies approved by TNI.
"Virginia Air Pollution Control Law" means Chapter 13 (§
					 10.1-1300 et seq.) of Title 10.1 of the Code of Virginia that is titled "Air
					 Pollution Control Board."
"Virginia Environmental Laboratory Accreditation Program"
					 or "VELAP" means the program DCLS operates to accredit environmental
					 laboratories under this chapter.
"Wastewater" means liquid and water-carried industrial
					 wastes and domestic sewage from residential dwellings, commercial buildings,
					 industrial and manufacturing facilities, and institutions.
"Waterworks" means each system of structures and appliances
					 used in connection with the collection, storage, purification, and treatment of
					 water for drinking or domestic use and the distribution thereof to the public,
					 except distribution piping.
"Zooplankton" means microscopic animals that float freely
					 with voluntary movement in a body of water.