California Code of Regulations › Title 22 - Social Security › Division 4 - Environmental Health › Chapter 19 - Certification of Environmental Laboratories › Article 1 - Definitions › Section 64801.00 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The definitions listed in 2016 TNI Standard - Revision 2.1,
					 Volume 1, Management and Technical Requirements for Laboratories Performing
					 Environmental Analysis, herein incorporated by reference, apply throughout this
					 chapter. Definitions used differently or that do not exist in 2016 TNI Standard
					 - Revision 2.1, Volume 1, are defined below.
(a) "Acceptable Scores" means analytical
				  results for a Proficiency Testing sample are within the specified acceptance
				  criteria for that sample.
(b)
				  "Accreditation" means the recognition of a laboratory by ELAP to conduct
				  analyses of environmental samples for Regulatory Purposes.
(c) "Assessment Agency" means ELAP or any
				  entity that is contracted by ELAP to conduct laboratory assessments for
				  ELAP.
(d) "CA-NV/AWWA" means
				  California-Nevada Section of the American Water Works Association.
(e) "Citation" means a monetary fine assessed
				  to a laboratory due to non-compliance with a statute, regulation, or order
				  issued or adopted pursuant to the Environmental Laboratory Accreditation
				  Act.
(f) "Client" means the entity
				  for which the laboratory is performing analyses for Regulatory
				  Purposes.
(g) "Complete Application
				  Package" means an application package containing all the elements required in
				  Section 64802.00.
(h) "Corrective Action Plan" means the
				  response to an onsite assessment report that contains a Root Cause Analysis of
				  the finding(s) identified in the onsite assessment report, the corrective
				  actions that will take place to address the findings, and the date by which the
				  finding(s) will be corrected.
(i)
				  "CWEA" means California Water Environment Association.
(j) "Days" means calendar days, unless
				  otherwise stated.
(k) "Denial"
				  means a decision to reject an application for accreditation due to
				  non-compliance with ELAP statutes and regulations.
(l) "ELAP" means the California Environmental
				  Laboratory Accreditation Program, a program within the State Water Resources
				  Control Board.
(m) "Field(s) of
				  Accreditation" means the matrix, technology/method, and analyte combinations
				  for which ELAP will offer accreditation, as defined in 2016 TNI Standard -
				  Revision 2.1, Volume 1, Module 2, herein incorporated by reference.
(n) "Owner" means a public agency, or any
				  person who is a sole proprietor of a laboratory, or any person who holds a
				  partnership interest in a laboratory, or any person who is an officer, or 5%
				  (five percent) or more shareholder in a corporation which owns a
				  laboratory.
(o) "Owner's Agent" or
				  "Agents of Owners" means those persons who have been designated by the Owner(s)
				  of the laboratory to act on its behalf for purposes of complying with ELAP
				  regulations or the statutes under which ELAP regulations are adopted.
(p) "Primary Accreditation Body" means the
				  organization that actually executes the accreditation process, including but
				  not limited to, receiving and reviewing applications, supporting documents,
				  Proficiency Testing sample results, and conducting on-site assessments or
				  reviewing on-site assessment reports.
(q) "Quality Manager" means a member of the
				  laboratory staff who is responsible for ensuring the management system related
				  to quality is implemented and followed at all times. Where staffing is limited,
				  the Technical Manager and Quality Manager may be the same person.
(r) "Quality Manual" is defined in 2016 TNI
				  Standard - Revision 2.1, Volume 1, Module 2, herein incorporated by reference,
				  and replaces the term Quality Assurance Manual.
(s) "Regulatory Purposes" is defined in
				  Health and Safety Code section
				  100825.
(t) "Revocation" means the permanent loss of
				  a certificate of accreditation due to non-compliance with ELAP statutes and
				  regulations.
(u) "Root Cause
				  Analysis" means an investigation by the laboratory to determine the underlying
				  cause(s) of a finding identified in an onsite assessment report or a
				  non-compliance identified by the laboratory.
(v) "Sophisticated Technology" means
				  analytical instruments, detection systems, and/or preparation techniques
				  requiring an advanced level of user understanding including gas
				  chromatography/mass spectrometry (GC/MS), inductively coupled plasma
				  spectrometry (ICP), inductively coupled plasma/mass spectrometry (ICP/MS),
				  liquid chromatography/mass spectrometry (LC/MS), atomic absorption
				  spectrophotometry (AA), gas chromatography (GC), alpha particle or gamma ray
				  spectrophotometry, electron microscopy (EM), polarized light microscopy (PLM),
				  high pressure performance liquid chromatography (HPLC), bioanalytical assays,
				  and advanced molecular methods.
(w)
				  "State Regulatory Agencies" means those state agencies whose statute or
				  regulations require it to use laboratories that have been accredited by
				  ELAP.
(x) "State Water Board" means
				  the California State Water Resources Control Board, which includes
				  ELAP.
(y) "Suspension" means the
				  total or partial removal of a laboratory's accreditation to allow the
				  laboratory to correct findings that identified non-compliance with ELAP
				  statutes and regulations.
(z)
				  "Technical Manager" is described in 2016 TNI Standard - Revision 2.1, Volume 1,
				  Module 2, Section
				  4.1.7.2, herein incorporated by
				  reference (with the exception of part [f]), and replaces the title of
				  Laboratory Director.
(aa) "TNI"
				  means The NELAC Institute.
(bb)
				  "Trade Secret" means any information that meets the definition in Government
				  Code section
				  6254.7(d).
(cc) "Trailer" means a vehicle designed for
				  carrying persons or property on its own structure and for being drawn by a
				  motor vehicle and so constructed that no part of its weight rests upon any
				  other vehicle. This definition is the same as the definition given in Vehicle
				  Code section
				  630.
1.
					 Renumbering of former section
					 64801 to new section
					 64801.00, including amendment of
					 section and NOTE, filed 11-19-2020; operative 1-1-2021 (Register 2020, No. 47).
					 (Filing deadline specified in Government Code section
					 11349.3(a)
					 extended by 60 calendar days pursuant to Executive Order
					 N-40-20.)
Note: Authority cited: Sections
						100829
						and
						100830,
						Health and Safety Code. Reference: Sections
						100825,
						100837,
						100870,
						100872,
						100880,
						100905,
						100907,
						100910
						and
						100915,
						Health and Safety Code.