2H_.0800 .1100 (002)

1

15A NCAC 02H .0801 is proposed for readoption : 1
2
15A NCAC 02H .0801 PURPOSE 3
The purpose of these Rules is to set out certificationCertification criteria for laboratory facilities performing any 4
tests, analyses, measurements, or monitoring required under G.S. 143 Article 21 or any rules adopted thereunder, 5
and to establish fees for certificationCertification program support. 6
7
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 8
Eff. February 1, 1976; 9
Amended Eff. November 2, 1992; December 1, 1984; November 1, 1978; 10
Temporary Amendment Eff. October 1, 2001; 11
Amended Eff. August 1, 2002. 12
13
Commented [SD1]: Terms defined within this Rule were capitalized throughout. Editorial – no impact. I will not add Comment boxes for those from this point forward.
2

15A NCAC 02H .0802 is proposed readoption : 1
2
15A NCAC 02H .0802 SCOPE 3
These Rules apply to laboratory facilities which perform and report analysestests, analyses, measurements or 4
monitoring for persons subject to G.S. 143-215.1, 143-215.1 and 143-215.63, et seq. seq.; the Environmental 5
Management Commission Rules for Surface Water Monitoring and Reporting found in Subchapter 2B of this 6
Chapter, Section .0500 (Only facilities classified in accordance with Classification of Water Pollution Control 7
Systems Rules found in 15A NCAC 08G .0300 are subject to these Rules.); Groundwater Rules found in 15A 8
NCAC 02L .0100, .0200, and .0300; Waste Not Discharged to Surface Waters Rules found in 15A NCAC 02H 9
.0200; Point Source Discharges to the Surface Waters Rules found in 15A NCAC 02H .0100. These Rules also 10
apply to all wastewater treatment plant laboratories for municipalities having Local Pretreatment Programs as 11
regulated in 15A NCAC 02H .0900. Laboratory facilities performing and reporting analyses for field parameters 12
only, shall be considered for certification as specified in Rule .0805(g) of this Section. These Rules do not apply to 13
facilities which are not classified in accordance with Classification of Water Pollution Control Systems Rules found 14
in 15A NCAC 08G .0300 and biological toxicity testing in accordance with 15A NCAC 2H .1100. 15
16
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 17
Eff. February 1, 1976; 18
Amended Eff. November 2, 1992; July 1, 1988; December 1, 1984; 19
Temporary Amendment Eff. October 1, 2001; 20
Amended Eff. August 1, 2002. 21
22
Commented [SD2]: Added language to include terms that better
characterize all parameters that fall under the scope of these Rules –
they are not all considered “analyses”.
Clarity – no impact.
Commented [SD3]: Rather than trying to list all Rules under the
G.S. that are subject, we just listed the G.S. and included the
exceptions per recommendation from DWR legal counsel. Ensures
no pertinent rule is overlooked and alleviates the need to update
when new rules are adopted.
Simplification and clarity – no impact.
3

15A NCAC 02H .0803 is proposed for readoption : 1
2
15A NCAC 02H .0803 DEFINITIONS 3
The following terms as used in this Section shall have the assigned meaning: 4
(1) "Analytical chemistry experience" means experience analyzing samples in a chemistry laboratory 5
or supervising a chemistry laboratory that analyzes samples. 6
(2) "Certification" means a declaration by the state that the personnel, equipment, records, quality 7
control procedures, and methodology cited by the applicant are accurate and that the applicant's 8
proficiency has been considered and found to be acceptable pursuant to these Rules. 9
(3) "Certified Data" shall be defined as any analytical result, including the supporting documentation, 10
obtained through the use of a method or procedure which has been deemed acceptable by the State 11
of North Carolina for Laboratory Certification purposes pursuant to these Rules. 12
(4) "Commercial Laboratory" means any laboratory, including its agents or employees, which is 13
seeking to analyze or is analyzing samples, including Field Parameters, for others for a fee. 14
(5) "Decertification" means loss of certification. 15
(6) "Falsified data or information" means data or information which has been made untrue by 16
alteration, fabrication, omission, substitution, or mischaracterization. The agency need not prove 17
intent to defraud to prove data is falsified. 18
(7) "Field Parameters", for the purpose of these Rules shall include Total Residual Chlorine, 19
Conductivity, Dissolved Oxygen, pH, Settleable Residue, and Temperature. 20
(8) "Inaccurate data or other information" means data or information that is in any way incorrect, or 21
mistaken. 22
(9) "Industrial Laboratory" means a laboratory, including its agents or employees, operated by an 23
industry to analyze samples, including Field Parameters, from its wastewater or wastewater from 24
its water treatment plant(s). 25
(10) "Municipal Laboratory" means a laboratory, including its agents or employees, operated by a 26
municipality or other local government to analyze samples, including Field Parameters, from its 27
wastewater or wastewater from its water treatment plant(s). 28
(11) "Other" laboratory means a facility that does not require laboratory certification as part of its 29
routine operation and does not analyze samples for a fee, or is doing business as a non-profit 30
facility. 31
(12) "Pretreatment Program" means a program of waste pretreatment requirements set up in accordance 32
with 15A NCAC 02H .0900 and approved by the Division of Water Quality. 33
(13) "State" means the North Carolina Department of Environment and Natural Resources, or its 34
successor. 35
(14) "State Laboratory" means the Laboratory Section of the North Carolina Division of Water Quality, 36
or its successor. 37
Commented [SD4]: Removed this language to allow for the
broader range of sample types in Industrial facility permits.
Technical correction – no effect
Commented [SD5]: Removed this language to allow for the
broader range of sample types in Municipal facility permits.
Technical correction – no effect
4

(15) "Unacceptable results" means those results on performance evaluation samples that exceed the 1
specified acceptable range as indicated by a US EPA accredited vendor. 2
(16) "Uncertified data" shall be defined as any analytical result, including the supporting 3
documentation, obtained using a method or procedure which is not acceptable to the State 4
Laboratory pursuant to these Rules. 5
(1) Acceptable Proficiency Testing results means those results on Proficiency Testing samples that are 6
within the Vendor-specified acceptable range as indicated by a State Laboratory approved Vendor 7
or Split samples that are within the specified acceptance range as indicated by the State 8
Laboratory. 9
(2) Analytical chemistry experience means experience analyzing samples in a chemistry laboratory or 10
supervising a chemistry laboratory that analyzes samples. 11
(3) Approved Procedure means an analytical procedure developed by the State Laboratory, based 12
upon relevant reference methods, and approved for use for monitoring subject to G.S. 143-215.1 13
and 143-215.63, et seq. 14
(4) Certification means a declaration by the State Laboratory that the personnel, equipment, records, 15
quality control procedures, and methodology cited by the applicant comply with these Rules and 16
that the applicant’s proficiency has been considered and found to be acceptable pursuant to these 17
Rules. 18
(5) Certified Data means any analytical result, including the Supporting Records, obtained through the 19
use of a method or procedure which has been deemed acceptable by the State Laboratory for 20
laboratory Certification purposes pursuant to these Rules. 21
(6) CFR means the Code of Federal Regulations. 22
(7) Commercial Laboratory means any laboratory, including its agents or employees, which is seeking 23
to analyze or is analyzing samples, including Field Parameters, for others for a fee. 24
(8) Decertification means loss of Certification. 25
(9) Director means Director of the Division of Water Resources or its successor. 26
(10) Division means the Division of Water Resources or its successor. 27
(11) Falsified Data or Information means data or information that, whether by intent or reckless 28
disregard for accuracy, has been altered, fabricated, or otherwise falsely mischaracterized by 29
omission or substitution, such that the value or information reported is incorrect, incomplete, 30
and/or inaccurate. The agency need not prove intent to defraud to prove data is falsified. 31
(12) Field Laboratory means a laboratory, including its agents or employees, which is seeking 32
Certification to analyze or is analyzing samples for Field Parameters only. 33
(13) Field Parameter(s) for the purpose of these Rules shall include Total Residual Chlorine, Free 34
Available Chlorine, Conductivity, Dissolved Oxygen, pH, Settleable Residue, Salinity, Sulfite, 35
Turbidity, Temperature, Vector Attraction Reduction Option 5, Vector Attraction Reduction 36
Option 6, and Vector Attraction Reduction Option 12. 37
Commented [SD6]: Added definition for clarity – no impact
Commented [SD7]: Added definition for clarity – this
potentially saves money for laboratories by eliminating the need to
purchase methods/compendiums for some parameters.
Commented [SD8]: Revised definition to provide clarity – no
impact
Commented [SD9]: Added definition for clarity – no impact
Commented [SD10]: Added definition for clarity – no impact

Commented [SD11]: Added definition for clarity – no impact
Commented [SD12]: Revised definition for clarity and improved legal defensibility based on DWR legal counsel’s recommendation and stakeholder input – no effect.
Commented [SD13]: Added definition for clarity – no impact
Commented [SD14]: Added additional parameters to the definition – this will potentially have a negative impact for some laboratories – by expanding the list of short-hold, field amenable tests, some labs may be able to change status from a Municipal/Industrial/Other lab to a Field Lab, where annual fees are less.
5

(14) Inaccurate data or other information means data or information that is in any way incorrect, or 1
mistaken. 2
(15) Industrial Laboratory means a laboratory, including its agents or employees, operated by an 3
industry to analyze samples under the scope of these Rules. 4
(16) In-situ means in the original or natural place or site; or an aliquot taken and analyzed immediately 5
(as soon as possible after collection) at the site. 6
(17) Matrix Spike means an additional aliquot of an environmental sample to which a known 7
concentration of the analyte(s) of interest is added before sample preparation, cleanup and 8
determinative procedures have been implemented. It is used to assess the performance of the 9
method by measuring the effects of interferences caused by the sample matrix and reflects the bias 10
of the method for the particular matrix in question. 11
(18) Mobile Laboratory means a collection of analytical equipment and instruments contained in an 12
environmentally controlled, covered, vehicle that can be deployed to a project site, for other than 13
Field Laboratory Certification purposes. All Mobile laboratories will be considered separate 14
laboratories and will require separate Certification. 15
(19) Municipal Laboratory means a laboratory, including its agents or employees, operated by a 16
municipality or other local government to analyze samples under the scope of these Rules. 17
Municipal Laboratories may cost-share among Municipal Laboratories or charge a cost recovery 18
fee or surcharge to operate their Pretreatment Program. 19
(20) NPDES means National Pollutant Discharge Elimination System. 20
(21) Other Laboratory means a facility that does not require State Laboratory Certification as part of its 21
routine operation and does not analyze samples for a fee, or is doing business as a non-profit 22
facility. 23
(22) Parameter means the analyte, element, compound, or property being measured. 24
(23) Parameter Method means a type of analytical technique, including materials and tools, used to 25
measure a parameter which is different from other analytical methods used to measure the same 26
parameter. 27
(24) Pretreatment Program means a program of waste pretreatment requirements set up in accordance 28
with 15A NCAC 02H .0900, et seq. and approved by the Division. 29
(25) Proficiency Testing (PT) sample means a performance evaluation sample whose true value is 30
unknown to the laboratory and provided by a State Laboratory approved Vendor to test whether 31
the laboratory can produce analytical results within the specified acceptance criteria. 32
(26) Recertification means re-instating Certification at the end of the Decertification period imposed by 33
the Division pursuant to 15A NCAC 02H .0807 by showing to the satisfaction of the State 34
Laboratory that is has corrected the deficiency(ies). 35
(27) Second Source means from a different manufacturer or from the same manufacturer and identified 36
by a different lot number. 37
Commented [SD15]: Added definition for clarity – no impact
Commented [SD16]: Added definition for clarity – no impact
Commented [SD17]: Added definition for clarity – currently
undefined - There are only 2 mobile laboratories certified currently.
This may potentially impact those laboratories since they have more
than one mobile unit certified under one certificate. This will depend
upon how they deploy those mobile units for NC projects and how
many units they determine they will need for NC to obtain
certification.
Commented [SD18]: Revised definition for clarity – no impact
Commented [SD19]: Added definition for clarity – no impact
Commented [SD20]: Added definition for clarity – no impact
Commented [SD21]: Added definition for clarity – gives
laboratories more flexibility and may potentially negatively impact
labs if a lab is decertified for a Parameter by multiple methods, the
laboratory could maintain certification for the unaffected methods
for that Parameter. Currently, the lab would be decertified for all
methods for that Parameter and would have to contract or
subcontract to a certified laboratory until the decertification period is
over and all requirements for recertification are met.
Commented [SD22]: Added definition for clarity – no impact
Commented [SD23]: Added definition for clarity – no impact
Commented [SD24]: Added definition for clarity – no impact
6

(28) Split sample means two or more representative portions taken from a sample or subsample and 1
analyzed by at least two laboratories approved by the State Laboratory. 2
(29) Standard Operating Procedure (SOP) means a prescriptive reference document that describes a 3
laboratory’s analytical or operational procedures with adequate detail to allow someone similarly 4
qualified to reproduce the procedures used to generate the test or desired result. 5
(30) State means the North Carolina Department of Environmental Quality, or its successor. 6
(31) State Laboratory means the Water Sciences Section, or its successor, including the Laboratory 7
Certification Branch of the North Carolina Division of Water Resources, or its successor. 8
(32) Supporting Record means any document or other source of information compiled, recorded or 9
stored in written form or by electronic process, or in any other manner that provides any 10
information necessary to historically reconstruct and/or characterize a reported value. 11
(33) Unacceptable Proficiency Testing results means those results on Proficiency Testing samples that 12
do not fall within the Vendor-specified acceptable range as indicated by a State Laboratory 13
approved Vendor; or Split samples that do not fall within the specified acceptable range as 14
indicated by the State Laboratory; or a failure to meet a reporting deadline imposed by the Vendor 15
or State Laboratory. 16
(34) Uncertified Data means any analytical result, including the Supporting Records, obtained using a 17
method or procedure which is not acceptable to the State Laboratory pursuant to these Rules; or 18
analytical results produced by a laboratory for an analysis not falling under the Scope of these 19
Rules; or analytical results produced by a laboratory without proper Certification. 20
(35) US EPA means the United States Environmental Protection Agency. 21
(36) Vector Attraction Reduction Option refers to the 12 numbered options for demonstrating a 22
reduction in vector attraction of sewage sludge in 40 CFR Part 503.33(b)(1) through (b)(12). 23
(37) Vendor means an accredited Proficiency Testing sample provider recognized by The NELAC 24
Institute (TNI) or its successor. 25
26
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 27
Eff. February 1, 1976; 28
Amended Eff. November 2, 1992; December 1, 1984; November 1, 1978; 29
Temporary Amendment Eff. October 1, 2001; 30
Amended Eff. August 1, 2002. 31
32
Commented [SD25]: Added definition for clarity – no impact
Commented [SD26]: Added definition for clarity – no impact
Commented [SD27]: Added definition for clarity – no impact
Commented [SD28]: Provides clarity by describing both PT
results and Split sample results and removes an obsolete reference to
EPA accredited vendor. EPA no longer accredits PT vendors. – no
effect
Commented [SD29]: Expanded to provide clarity – no effect
Commented [SD30]: Added definition for clarity – no impact
Commented [SD31]: Added definition for clarity - no impact
Commented [SD32]: Added definition for clarity – no impact
7

15A NCAC 02H .0804 is proposed for readoption : 1
2
15A NCAC 02H .0804 PARAMETERS FOR WHICH CERTIFICATION MAY BE REQUESTED 3
(a) Commercial laboratoriesLaboratories are required to obtain certificationCertification for parametersParameter 4
Methods used to generate data which will be reported by the client to the State in accordance with Rule .0802 of this 5
Section. comply with State surface water monitoring, groundwater, and pretreatment Rules. Municipal and Industrial 6
Laboratories are required to obtain certificationCertification for parametersParameter Methods used to generate data 7
which will be reported to the State in accordance with Rule .0802 of this Section. to comply with State surface water 8
monitoring, groundwater, and pretreatment Rules. Commercial, Municipal, and Industrial and Other Commercial 9
Laboratoriesfacilities are required to obtain certificationCertification for fieldField parametersParameter Methods 10
used to generate data which will be reported by the client to the State in accordance with Rule .0802 of this Section. 11
comply with State surface water, groundwater, and pretreatment Rules.Municipal and Industrial laboratories are 12
required to obtain Certification for Field Parameter Methods used to generate data which will be reported to the 13
State in accordance with Rule .0802 of this Section. 14
(b) Inorganics: Each of the inorganic, physical characteristic and microbiological analytes listed in this paragraph 15
will be considered a certifiable parameter. Analytical methods shall be determined from the sources listed in Rule 16
.0805 (a) (1) of this Section. One or more analytical methods or Parameter Methods may be listed with a 17
laboratory’s certified parameters. A listing of certifiable inorganic, physical characteristic and microbiological 18
parameters follows: 19
(1) Alkalinity 20
(2) Aquatic Humic Substances 21
(3) BOD 22
(4) COD 23
(5) Chloride 24
(6) Chlorine, Total Residual 25
(7) Chlorophyll 26
(8) Coliform, Fecal 27
(9) Coliform, Total 28
(10) Color 29
(11) Conductivity 30
(12) Cyanide 31
(13) Dissolved Oxygen 32
(14) Fluoride 33
(15) Hardness, Total 34
(16) MBAS 35
(17) Ammonia Nitrogen 36
(18) Total Kjeldahl Nitrogen (TKN) 37
Commented [SD33]: Editorial changes to capitalize defined
terms and make wording consistent to provide clarity – no impact.
Commented [SD34]: Added language to better define Inorganics – provides clarity – no impact.
Commented [SD35]: Removed – not necessary – no impact
8

(19) Nitrate plus Nitrite Nitrogen 1
(20) Nitrate Nitrogen 2
(21) Nitrite Nitrogen 3
(22) Total Phosphorus 4
(23) Orthophosphate 5
(24) Oil and Grease 6
(25) pH 7
(26) Phenols 8
(27) Residue, Settleable 9
(28) Residue, Total 10
(29) Residue, Total Dissolved 180C 11
(30) Residue, Total Suspended 12
(31) Salmonella 13
(32) Sulfate 14
(33) Sulfide 15
(34) Sulfite 16
(35) Temperature 17
(36) Total Organic Carbon (TOC) 18
(37) Turbidity 19
(38) Leachate Procedures 20
(39) Vector Attraction Reduction - All Options 21
(1) Acidity 22
(2) Alkalinity 23
(3) Biochemical Oxygen Demand 24
(4) Bromide 25
(5) Carbonaceous Biochemical Oxygen Demand 26
(6) Chemical Oxygen Demand 27
(7) Chloride 28
(8) Chlorine, Free Available 29
(9) Chlorine, Total Residual 30
(10) Chlorophyll 31
(11) Coliform, Fecal 32
(12) Coliform, Total 33
(13) Color 34
(14) Conductivity/Specific Conductance 35
(15) Cyanide 36
(16) Dissolved Organic Carbon 37
Commented [SD36]: Added parameter currently approved by Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-public/Water Quality/Chemistry Lab/Certification/Memos/new methods memo 2002.pdf
Commented [SD37]: Added parameter currently approved by Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Memos/Bromide%20approval%20to%20certify%202012.pdf
Commented [SD38]: Added parameter currently approved by
Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Memos/Fr
eeAvailableChlorineDirectorApproval2012.pdf
Commented [SD39]: Provided clarification that the parameter
includes Conductivity measured at ambient and 25°C temperatures –
no effect.
Commented [SD40]: Added parameter currently approved by Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Memos/AdditionalParameterDirectorApprovalLetter-03022007-DWQ-LAB-CERT.pdf
9

(17) Dissolved Oxygen 1
(18) Enterococci 2
(19) Escherichia Coliform (E. coli) 3
(20) Flash Point 4
(21) Fluoride 5
(22) Hardness, Total 6
(23) Ignitability 7
(24) Surfactants as Methylene Blue Active Surfactants 8
(25) Nitrogen, Ammonia 9
(26) Nitrogen, Nitrite plus Nitrate 10
(27) Nitrogen, Nitrate 11
(28) Nitrogen, Nitrite 12
(29) Nitrogen, Total Kjeldahl 13
(30) Oil and Grease 14
(31) Orthophosphate 15
(32) Paint Filter Liquids 16
(33) pH 17
(34) Phenols 18
(35) Phosphorus, Total 19
(36) Residue, Settleable 20
(37) Residue, Total 21
(38) Residue, Total Dissolved 22
(39) Residue, Total Suspended 23
(40) Residue, Volatile 24
(41) Salinity 25
(42) Salmonella 26
(43) Silica 27
(44) Sulfate 28
(45) Sulfide 29
(46) Sulfite 30
(47) Temperature 31
(48) Total Organic Carbon 32
(48) Turbidity 33
(49) Vector Attraction Reduction: Option 1 34
(50) Vector Attraction Reduction: Option 2 35
(51) Vector Attraction Reduction: Option 3 36
(52) Vector Attraction Reduction: Option 4 37
Commented [SD41]: Editorial, changed format of parameter
name for clarity – no effect
Commented [SD42]: Added parameter currently approved by Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Memos/AdditionalParameterDirectorApprovalLetter-03022007-DWQ-LAB-CERT.pdf
Commented [SD43]: Added parameter currently approved by
Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Memos/A
dditionalParameterDirectorApprovalLetter-03022007-DWQ-LAB-
CERT.pdf
Commented [SD44]: Currently certified under the Ignitability Parameter, but separated in proposed revision since Flash Point is actually a different method-defined parameter – technical correction
- https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Memos/ne
w%20methods%20memo%202002.pdf – could impact some
laboratories that elect to maintain certification for both Flash Point
and Ignitability since they will be charged separately but only if they
are above the minimum annual fee; however may save some labs
money in the event they are decertified for one of the parameters,
since they would lose certification for only that parameter and not
both.
Commented [SD45]: Added parameter currently approved by Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Memos/new%20methods%20memo%202002.pdf
Commented [SD46]: Changed to parameter name format in 40
CFR Part 136 and provides clarity – no effect
Commented [SD47]: Changed parameter name format to provide consistency – no effect
Commented [SD48]: Added parameter currently approved by
Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Memos/ne
w%20methods%20memo%202002.pdf
Commented [SD49]: Added parameter currently approved by
Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Memos/AdditionalParameterDirectorApprovalLetter2-10052007-DWQ-LAB-CERT.jpg
Commented [SD50]: Added parameter currently approved by
Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Memos/A
dditionalParameterDirectorApprovalLetter2-10052007-DWQ-LAB-
CERT.jpg
Commented [SD51]: Added parameter currently approved by Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Memos/AdditionalParameterDirectorApprovalLetter-03022007-DWQ-LAB-CERT.pdf
10

(53) Vector Attraction Reduction: Option 5 1
(54) Vector Attraction Reduction: Option 6 2
(55) Vector Attraction Reduction: Option 7 3
(56) Vector Attraction Reduction: Option 8 4
(57) Vector Attraction Reduction: Option 12 5
(c) Metals: Each of the metals and certified leaching procedures for metals listed in this Paragraph following will be 6
considered a certifiable parameter. Metals analyte: One or more Parameter Methods may be listed with a 7
laboratory’s certified parameters. Analytical methods shall be determined from the sources listed in Rule .0805 (a) 8
(1) of this Section. A listing of certifiable metals and leaching procedures follows: 9
(1) Aluminum 10
(2) Antimony 11
(3) Arsenic 12
(4) Barium 13
(5) Beryllium 14
(6) Cadmium 15
(7) Calcium 16
(8) Chromium, Total 17
(9) Chromium, Hexavalent 18
(10) Cobalt 19
(11) Copper 20
(12) Iron 21
(13) Lead 22
(14) Magnesium 23
(15) Manganese 24
(16) Mercury 25
(17) Molybdenum 26
(18) Nickel 27
(19) Selenium 28
(20) Silver 29
(21) Thallium 30
(22) Tin 31
(23) Vanadium 32
(24) Zinc 33
(6) Boron 34
(7) Cadmium 35
(8) Calcium 36
(9) Chromium, Hexavalent (Chromium VI) 37
Commented [SD52]: Currently listed as Vector Attraction
Reduction – All Options. Split out for clarity since Options 9, 10 and
11 are not necessary and should be excluded from the scope of this
certification. May potentially impact some laboratories if they elect
to maintain certification for multiple options since they will be
charged separately but only if they are above the annual fee
minimum.
Commented [SD53]: Added language to better define Metals – provides clarity – no impact.
Commented [SD54]: Added parameter currently approved by Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Memos/new%20methods%20memo%202002.pdf
Commented [SD55]: Provide clarity – no effect
11

(10) Chromium, Total 1
(11) Chromium, Trivalent (Chromium III) 2
(12) Cobalt 3
(13) Copper 4
(14) Hardness, Total (Calcium + Magnesium) 5
(15) Iron 6
(16) Lead 7
(17) Lithium 8
(18) Magnesium 9
(19) Manganese 10
(20) Mercury 11
(21) Molybdenum 12
(22) Nickel 13
(23) Potassium 14
(24) Phosphorus 15
(25) Selenium 16
(26) Silica 17
(27) Silver 18
(28) Sodium 19
(29) Strontium 20
(30) Thallium 21
(31) Tin 22
(32) Titanium 23
(33) Vanadium 24
(34) Zinc 25
(35) Synthetic Precipitation Leaching Procedure for Metals (SPLP) 26
(36) Toxicity Characteristic Leaching Procedure for Metals (TCLP) 27
(d) Organics: Each of the organic parameters analytical categories and certified leaching procedures for organics 28
listed in this Paragraph shall be considered a certifiable parameter. One or more Parameter Methods may be listed 29
with a laboratory’s certified parameters. Analytical methods shall be determined from the sources listed in Rule 30
.0805(a) (1) of this Section. A listing of certifiable organic parameters and leaching procedures follows: 31
(1) Purgeable Halocarbons 32
(2) Purgeable Aromatics 33
(3) Acrolein, Acrylonitrile, Acetonitrile 34
(4) Phenols 35
(5) Benzidines 36
(6) Phthalate Esters 37
Commented [SD56]: Added this parameter based on anticipated
monitoring requirements. May impact labs if they elect to add this to
their scope of certification and are over the minimum annual fee.
Commented [SD57]: Added this parameter under the metals
subsection for clarity to indicate method of derivation – May impact
labs if they elect to add this to their scope of certification in addition
to inorganic Hardness methods and are over the minimum annual
fee.
Commented [SD58]: Added parameter currently approved by Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Memos/AdditionalParameterDirectorApprovalLetter-03022007-DWQ-LAB-CERT.pdf
Commented [SD59]: Added parameter currently approved by
Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Memos/ne
w%20methods%20memo%202002.pdf
Commented [SD60]: Added parameter currently approved by
Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Memos/A
dditionalParameterDirectorApprovalLetter-03022007-DWQ-LAB-
CERT.pdf
Commented [SD61]: Added parameter currently approved by Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Memos/new%20methods%20memo%202002.pdf
Commented [SD62]: Added parameter currently approved by
Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Memos/A
dditionalParameterDirectorApprovalLetter-03022007-DWQ-LAB-
CERT.pdf
Commented [SD63]: Added parameter currently approved by Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Memos/AdditionalParameterDirectorApprovalLetter-03022007-DWQ-LAB-CERT.pdf
Commented [SD64]: Moved placement under Metals and split
out TCLP from SPLP for clarity since they are different method-
defined parameters. May potentially impact laboratories that elect to
maintain certification for both parameters and are above the
minimum annual fee since they will be charged separately.
Commented [SD65]: Added language to better define Organics – provides clarity – no impact.
12

(7) Nitrosamines 1
(8) Organochlorine Pesticides 2
(9) Polychlorinated Biphenyls 3
(10) Nitroaromatics and Isophorone 4
(11) Polynuclear Aromatic Hydrocarbons 5
(12) Haloethers 6
(13) Chlorinated Hydrocarbons 7
(14) Purgeable Organics 8
(15) Base/Neutral and Acid Organics 9
(16) Chlorinated Acid Herbicides 10
(17) Organophosphorus Pesticides 11
(18) Total Petroleum Hydrocarbons - (TPH) California GC Method - Diesel Range Organics 12
(19) Total Petroleum Hydrocarbons - (TPH) California GC Method - Gasoline Range Organics 13
(20) Nonhalogenated Volatile Organics 14
(21) N-Methylcarbamates 15
(22) 1,2, Dibromoethane (EDB) 16
(23) Extractable Petroleum Hydrocarbons 17
(24) Volatile Petroleum Hydrocarbons 18
(25) Chlorinated Phenolics 19
(26) Adsorbable Organic Halides 20
(1) 1,2-Dibromoethane (EDB); 1,2-Dibromo-3-chloro-propane (DBCP); 1,2,3-Trichloropropane 21
(TCP) 22
(2) Acetonitrile 23
(3) Acrolein, Acrylonitrile 24
(4) Adsorbable Organic Halides 25
(5) Base/Neutral and Acid Organics 26
(6) Benzidines 27
(7) Chlorinated Acid Herbicides 28
(8) Chlorinated Hydrocarbons 29
(9) Chlorinated Phenolics 30
(10) Explosives 31
(11) Extractable Petroleum Hydrocarbons 32
(12) Haloethers 33
(13) N-Methylcarbamates 34
(14) Nitroaromatics and Isophorone 35
(15) Nitrosamines 36
(16) Nonhalogenated Volatile Organics 37
Commented [SD66]: Removed – Not necessary
Commented [SD67]: Added these additional analytes to the parameter to allow laboratories the opportunity to obtain certification for the additional constituents found in the EDB methods. – No effect
Commented [SD68]: Split out Acetonitrile from the Acrolein,
Acrylonitrile parameter to reflect current approved reference
methods target analyte lists. May potentially impact some
laboratories which may elect to maintain certification for both
parameters and which are above the minimum annual fee since they
will be charged separately.
Commented [SD69]: Added this parameter based on anticipated monitoring requirements. May impact labs if they elect to add this to their scope of certification and are over the minimum annual fee.
13

(17) Organochlorine Pesticides 1
(18) Organophosphorus Pesticides 2
(19) Phenols 3
(20) Phthalate Esters 4
(21) Polychlorinated Biphenyls 5
(22) Polynuclear Aromatic Hydrocarbons 6
(23) Purgeable Aromatics 7
(24) Purgeable Halocarbons 8
(25) Purgeable Organics 9
(26) Total Organic Halides 10
(27) Total Petroleum Hydrocarbons – Diesel Range Organics 11
(28) Total Petroleum Hydrocarbons – Gasoline Range Organics 12
(29) Volatile Petroleum Hydrocarbons 13
(30) Synthetic Precipitation Leaching Procedure for Organics (SPLP) 14
(31) Toxicity Characteristic Leaching Procedure for Organics (TCLP) 15
16
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 17
Eff. February 1, 1976; 18
Amended Eff. November 2, 1992; December 1, 1984; 19
Temporary Amendment Eff. October 1, 2001; 20
Amended Eff. August 1, 2002. 21
22
Commented [SD70]: Added parameter currently approved by Director’s letter – no effect - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Memos/new%20methods%20memo%202002.pdf
Commented [SD71]: Moved placement under Organics and
split out TCLP from SPLP for clarity and since they are different
method-defined parameters. May potentially impact laboratories that
elect to maintain certification for both since they will be charged
separately.
14

15A NCAC 02H .0805 is proposed for readoption : 1
2
15A NCAC 02H .0805 CERTIFICATION AND RENEWAL OF CERTIFICATION 3
(a) Prerequisites and requirements for Certification. The following requirements must be met by all laboratories, 4
excluding Field Laboratories, prior to certificationCertification. Once certified, failure to comply with any of the 5
following items will be a violation of certificationCertification requirements. All "Field Parameter" only 6
facilityField Laboratory requirements are located in Paragraph (g) of this Rule. 7
(1) Laboratory Procedures. Analytical methods, sample preservation, sample containers and sample 8
holding times shall conform to those requirements found in 40 CFR-136.3; Standard Methods for 9
the Examination of Water and Wastewater, 18th Edition; or Test Methods for Evaluating Solid 10
Waste, SW 846, Third Edition. These and subsequent amendments and editions are incorporated 11
by reference. This material is available for inspection at the State Laboratory, 4405 Reedy Creek 12
Road, Raleigh, North Carolina, 27607. Copies of the Code of Federal Regulations, 40 CFR Part 13
136, may be obtained for a cost of forty-two dollars ($42.00), from the Superintendent of 14
Documents, U.S. Government Printing Office (GPO), Superintendent of Public Documents, 15
Washington, DC, 20402. The publication number is 869-042-00148-6. Standard Methods for the 16
Examination of Water and Waste, is available for purchase from the American Water Works 17
Association (AWWA), 6666 West Quincy Avenue, Denver, CO 80235. The costs are as follows: 18
18th Edition -one hundred sixty dollars ($160.00), 19th Edition - one hundred eighty dollars 19
($180.00), 20th Edition - two hundred dollars ($200.00). Copies of Test Methods for Evaluating 20
Solid Waste, SW 846, Third Edition may be purchased for a cost of three hundred sixty seven 21
dollars ($367.00) from the Superintendent of Documents, U.S. Government Printing Office 22
(GPO), Washington, DC 20402. Vector Attraction Reduction Options shall be Control of 23
Pathogens and Vector Attraction in Sewage Sludge; EPA/625/R-92/013, Chapter 8. The document 24
is available from US EPA; Office of Research and Development, Washington, NC 20460 at no 25
cost. The method for Total Petroleum Hydrocarbons shall be the California Gas Chromatograph 26
Method, Eisenberg, D.M., and others, 1985, Guidelines for Addressing Fuel Leaks: California 27
Regional Quality Control Board San Francisco Bay Region. The method for Total Petroleum 28
Hydrocarbons is available from the State Laboratory at no cost. The methods for Volatile 29
Petroleum Hydrocarbons and Extractable Petroleum Hydrocarbons shall be Massachusetts 30
Department of Environmental Protection, Method for the Determination of Volatile Petroleum 31
Hydrocarbons (VPH) and Method for the Determination of Extractable Petroleum Hydrocarbons 32
(EPH); January, 1998. The Director may approve other analytical procedures that have been 33
demonstrated to produce verifiable and repeatable results and that have a widespread acceptance 34
in the scientific community. 35
(1) Laboratory Procedures. Analytical methods, sample preservation, sample containers and sample 36
holding times shall conform to those requirements found in: 37
Commented [SD72]: Editorial – no effect
15

(A) 40 CFR Part 136 and 40 CFR Part 503; 1
(B) Standard Methods for the Examination of Water and Wastewater; 2
(C) Test Methods for Evaluating Solid Waste, SW-846, Third Edition; 3
(D) Control of Pathogens and Vector Attraction in Sewage Sludge; EPA/625/R-92/013; 4
(E) Massachusetts Department of Environmental Protection, Method for the Determination of 5
Volatile Petroleum Hydrocarbons (VPH) and Method for the Determination of 6
Extractable Petroleum Hydrocarbons (EPH); May, 2004, Revision 1.1; and 7
(F) The State Laboratory may develop Approved Procedures for Field Parameters based 8
upon the methods in any of the sources referenced above. 9
(G) These and subsequent amendments, revisions and editions are incorporated by reference. 10
(H) This material is available for inspection at the State Laboratory, 4405 Reedy Creek Road, 11
Raleigh, North Carolina, 27607 or may be obtained from: 12
(i) Copies of the Code of Federal Regulations, 40 CFR Part 136 and 40 CFR Part 13
503, may be obtained from the Superintendent of Documents, U.S. Government 14
Printing Office (GPO), Superintendent of Public Documents, Washington, D.C., 15
20402 and free of charge on the internet at http://www.ecfr.gov. 16
(ii) Standard Methods for the Examination of Water and Wastewater, is available 17
for purchase from American Water Works Association (AWWA), 6666 West 18
Quincy Avenue, Denver, CO 80235; American Public Health Association 19
(APHA), 8001 Street, NW, Washington, D.C. 20001; or Water Environment 20
Federation (WEF), 601 Wythe Street, Alexandria, VA 22314; and 21
http://www.standardmethods.org/. 22
(iii) Copies of Test Methods for Evaluating Solid Waste, SW-846, Third Edition 23
may be obtained from the Superintendent of Documents, U.S. Government 24
Printing Office (GPO), Washington, D.C. 20402 and free of charge on the 25
internet at http://www.epa.gov/osw/hazard/testmethods/sw846/online/. 26
(iv) Vector Attraction Reduction Options shall be Control of Pathogens and Vector 27
Attraction in Sewage Sludge; EPA/625/R-92/013. The document is available 28
from US EPA; Office of Research and Development, Washington, D.C. 20460 29
and free of charge on the internet at 30
http://www.water.epa.gov/scitech/wastetech/biosolids/. 31
(v) The methods for Volatile Petroleum Hydrocarbons and Extractable Petroleum 32
Hydrocarbons shall be Massachusetts Department of Environmental Protection, 33
Method for the Determination of Volatile Petroleum Hydrocarbons (VPH) and 34
Method for the Determination of Extractable Petroleum Hydrocarbons (EPH); 35
May, 2004, Revision 1.1. These methods may be obtained from the 36
Massachusetts Department of Environmental Protection, Senator William X. 37
Commented [SD73]: No new requirement added - http://deq.nc.gov/about/divisions/water-resources/water-resources-data/water-sciences-home-page/laboratory-certification-branch/technical-assistance-policies - may potentially have a negative impact on some laboratories since they would not have to purchase some approved reference methods.
16

Wall Experiment Station, 37 Shattuck Street, Lawrence, MA, 01843-1398 and 1
free of charge on the internet at 2
http://www.mass.gov/eea/docs/dep/cleanup/laws/vph0504.pdf and 3
http://www.mass.gov/eea/docs/dep/cleanup/laws/eph0504.pdf, respectively. 4
(vi) State Laboratory Approved Procedures for Field Parameters may be obtained by 5
request from the State Laboratory or on the State Laboratory Certification 6
website at http://portal.ncdenr.org/web/wq/lab/cert. 7
(J) The Director or assigned delegate may approve other analytical procedures, parameters or 8
Parameter Methods that have been demonstrated to produce verifiable and repeatable 9
results and that have a widespread acceptance in the scientific community. 10
(2) Performance Evaluations. Annually, each certified laboratory must demonstrate acceptable 11
performance on evaluation samples as required by these Rules. 12
(2) Proficiency Testing. Annually, each certified laboratory must demonstrate acceptable performance 13
on a minimum of one evaluation sample, for all Parameter Methods listed on their Certified 14
Parameters Listing for which Proficiency Testing samples are readily available, as required by 15
these Rules. When two Proficiency Testing samples for the same Parameter Method are analyzed 16
and submitted at the same time, an unacceptable result on one or both samples will be considered 17
the first unacceptable result for Certification purposes. A laboratory that submits Unacceptable 18
Proficiency Testing results for two Proficiency Testing samples for the same Parameter Method 19
submitted at the same time must analyze a remedial Proficiency Testing sample to demonstrate a 20
return to control and send a corrective action report to the State Laboratory that details the root 21
cause of the failure and the corrective action(s) taken to prevent recurrence. Proficiency Testing 22
samples must be analyzed in the same manner that routine samples are analyzed using the same 23
staff, sample tracking, sample preparation and analysis methods, standard operating procedures, 24
calibration techniques, quality control procedures and acceptance criteria. 25
(A) Municipal and Industrial laboratories must participate in the annual Environmental 26
Protection Agency Discharge Monitoring Report Quality Assurance (EPA/DMR/QA) 27
Study by analyzing performance evaluation samples obtained from an accredited vendor 28
as unknowns, and reporting data produced to the State. The laboratory is responsible for 29
submitting acceptable results for all parameters listed on their certificate. 30
(A) All laboratories must participate annually in an evaluation study(ies) by analyzing 31
Proficiency Testing samples obtained from a State Laboratory approved Vendor as 32
unknowns, and arranging with the Vendor to send the graded results directly to the State 33
Laboratory by the date due. A laboratory that submits Unacceptable Proficiency Testing 34
results must analyze a remedial Proficiency Testing sample using the same Parameter 35
Method to demonstrate a return to control and send a corrective action report to the State 36
Commented [SD74]: No new requirement added - http://deq.nc.gov/about/divisions/water-resources/water-resources-data/water-sciences-home-page/laboratory-certification-branch/technical-assistance-policies - may potentially have a negative impact on some laboratories since they would not have to
purchase some approved reference methods.
Commented [SD75]: Updated contact information, added URLs
and reformatted the Rule for easier readability – no effect
Commented [SD76]: No new requirement added – updated to
current industry nomenclature -
https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Technical
%20Assistance%20Documents/PTRequirementsDocument20120120Revision%201.2F.pdf
17

Laboratory that details the root cause of the failure and the corrective action(s) taken to 1
prevent recurrence. 2
(B) Commercial laboratories must participate annually in water pollution studies by 3
analyzing performance evaluation samples obtained from an accredited vendor as 4
unknowns, and reporting data produced to the State. The laboratory is responsible for 5
submitting acceptable results for all parameters listed on their certificate. When two 6
samples for the same parameter are submitted and analyzed at the same time, an 7
unacceptable result on one or both samples will be considered the first unacceptable 8
result for certification purposes and a rerun sample must be submitted. 9
(C)(B) Laboratories requesting initial certificationCertification or additional Parameter Method 10
Certification must submit an acceptable performance Proficiency Testing sample result 11
from the most recent attempt analyzed within the last six months, for each 12
parameterParameter Method for which performance Proficiency Testing samples are 13
readily available. Laboratories must analyze Proficiency Testing samples obtained from a 14
State Laboratory approved Vendor as unknowns and arrange with the Vendor to send the 15
graded results directly to the State Laboratory. Laboratories that submit two consecutive 16
unacceptableUnacceptable Proficiency Testing results for a particular parameter 17
Parameter Method must then submit two consecutive acceptableAcceptable Proficiency 18
Testing results from the most recent attempt analyzed within the six months prior to 19
initial Certification for that parameter Parameter Method.prior to initial certification. 20
(D)(C) If Proficiency Testing performance samples are not readily available, available for a 21
parameter, Certificationcertification for that parameter will be based on the proper use of 22
the approved procedure, the on-site inspection, andand/or adherence to the other 23
requirements in this Section. Analysis of splitSplit samples may also be required. 24
(3) Supervisory Requirements. 25
(A) The supervisor of a commercial laboratoryCommercial Laboratory must have a minimum 26
of a B.S. or A.B. four-year degree in chemistry or closely related science curriculum from 27
an accredited college or university plus a minimum of two years laboratory experience in 28
analytical chemistry, or a two year two-year associate degree from an accredited college, 29
university, or technical institute in chemistry technology, environmental sciences, or 30
closely related science curriculum plus a minimum of four years experience in analytical 31
chemistry. 32
(B) The supervisor of a municipal or industrial waste water treatment plant non-Commercial 33
Municipal, Industrial, Mobile or Other Laboratorylaboratory must have a minimum of a 34
B.S. or A.B. four-year degree in chemistry or closely related science curriculum from an 35
accredited college or university plus a minimum of six months laboratory experience in 36
analytical chemistry or an equivalent combination of education and work experience, or a 37
Commented [SD77]: No new requirement added – updated to
current industry nomenclature -
https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Technical
%20Assistance%20Documents/PTRequirementsDocument20120120
Revision%201.2F.pdf
Commented [SD78]: No new requirement added – updated to current industry nomenclature - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Technical%20Assistance%20Documents/PTRequirementsDocument20120120Revision%201.2F.pdf
Commented [SD79]: Editorial – no effect
Commented [SD80]: Editorial – no effect
Commented [SD81]: Editorial – no effect
18

two year two-year associate degree from an accredited college, university, or technical 1
institute in chemistry technology, environmental sciences, or closely related science 2
curriculum plus a minimum of two years experience in analytical chemistry or an 3
equivalent combination of education and work experience. Non-degree supervisors must 4
have at least six years laboratory experience in analytical chemistry or an equivalent 5
combination of education and work experience. 6
(C) All laboratory supervisors are subject to review by the State Laboratory. One person may 7
serve as supervisor of no more than two certified laboratories. The supervisor shall 8
provide personal and direct supervision of the technical personnel and be held responsible 9
for the proper performance and reporting of all analyses made for these Rules. The 10
supervisor must work in the laboratory or visit contact the laboratory once each day of 11
normal operations and Supporting Records shall be maintained as evidence. If the 12
supervisor is to be absent, the supervisor shall arrange for a substitute capable of insuring 13
the proper performance of all laboratory procedures, however, the substitute supervisor 14
cannot be in charge for more than six twelve consecutive weeks. Existing laboratory 15
supervisors that do not meet the requirements of this Rule may be accepted after review 16
by the State Laboratory and meeting all other certification requirements. Previous 17
laboratory-related performance will be considered when reviewing the qualifications of a 18
potential laboratory supervisor. 19
(4) Laboratory Manager. Each laboratory must designate a laboratory manager and include his their 20
name and title on the application for certificationCertification. The laboratory manager shall be 21
administratively above the laboratory supervisor and will be in responsible charge in the event the 22
laboratory supervisor ceases to be employed by the laboratory and will be responsible for filling 23
the laboratory supervisor position with a replacement qualified pursuant to these Rules. At 24
commercial laboratories,Commercial Laboratories, where the owner is the laboratory supervisor, 25
the laboratory manager and laboratory supervisor may be the same person if there is no one 26
administratively above the laboratory supervisor. 27
(5) Application. Each laboratory requesting initial state certificationCertification shall submit an 28
application in duplicate, accompanied by the application fee and the laboratory's Quality 29
Assurance Manual Manual, including Standard Operating Procedures for all requested Parameter 30
Methods, to the State Laboratory. Separate application and Certification shall be required for 31
Mobile Laboratories and the applicant must supply the vehicle make, vehicle identification 32
number and license number where applicable. Separate application and certificationCertification 33
shall be required for all stationary laboratories maintained on separate premises even though 34
operated under the same management; however, separate certificationCertification is not required 35
for separate buildings on the same or adjoining grounds. Analysis of Field Parameters away from 36
the physical location of the laboratory is permitted without separate Certification. After receiving a 37
Commented [SD82]: Provides clarity – no effect
Commented [SD83]: Allows the laboratories more flexibility in
meeting supervisory obligations – less stringent
Commented [SD84]: Extended length of time to be in concert
with current FRMLA policies – less stringent
Commented [SD85]: Removed – not necessary – this language
was in the original Rule to grandfather existing supervisors into the
program.
Commented [SD86]: Removed the requirement to reduce paper
waste – negative impact
Commented [SD87]: Provides clarity that SOPs must be submitted when they are not a part of a laboratory’s Quality Assurance Manual – no effect
Commented [SD88]: There are only 2 mobile laboratories certified currently. This may potentially impact those laboratories since they have more than one mobile unit certified under one certificate. This will depend upon how they deploy those mobile units for NC projects and how many units they determine they will need for NC to obtain certification.
Commented [SD89]: Provides clarity – no new requirement
19

completed application and prior to issuing certification,Certification, a representative of the State 1
Laboratory may visit each laboratory to verify the information in the application and the adequacy 2
of the laboratory. 3
(6) Properly Maintained Facilities, Supplies, and Equipment. Facilities and equipment. Each 4
laboratory requesting certificationCertification must be properly maintained so as to ensure the 5
security and integrity of samples. A best effort must be made to perform analyses in a manner 6
where possible sources of contamination or error will not be introduced. Each facility must contain 7
or be equipped with the following: 8
(A) A minimum of 150 sq. ft. of laboratory space; 9
(B) A minimum of 12 linear feet of laboratory bench space; 10
(C) A sink with hot and cold water; 11
(D) An analytical balance capable of weighing 0.1 mg, mounted on a shock proof table; 12
(E) A refrigerator of adequate size to store all samples and maintain temperature of four 13
degrees Celsius; 14
(F) A copy of each approved analytical procedure being used in the laboratory; 15
(G) A source of distilled or deionized water that will meet the minimum criteria of the 16
approved methodologies; 17
(H) Glassware, chemicals, supplies, and equipment required to perform all analytical 18
procedures included in their certification. 19
(A) A source of water that will meet the minimum criteria of the approved methodologies; 20
(B) Glassware, chemicals, supplies and equipment required to perform all tests, analyses, 21
measurements, or monitoring included in their Certification. 22
(7) Analytical Quality Control Program. Each laboratory shall develop and maintain a document 23
outlining the analytical quality control practices used for the parameters included in their 24
certification. Supporting records shall be maintained as evidence that these practices are being 25
effectively carried out. The quality control document shall be available for inspection by the State 26
Laboratory. The following are requirements for certification and must be included in each certified 27
laboratory's quality control program: 28
(A) All analytical data pertinent to each certified analysis must be filed in an orderly manner 29
so as to be readily available for inspection upon request. 30
(B) Excluding Oil and Grease, all residue parameters, leachate extractions, residual chlorine, 31
and coliform, analyze one known standard in addition to calibration standards each day 32
samples are analyzed to document accuracy. Analyze one suspended residue, one 33
dissolved residue, one residual chlorine and one oil and grease standard quarterly. For 34
residual chlorine, all calibration standards required by the approved procedure in use and 35
by EPA must be analyzed. 36
Commented [SD90]: No new requirement - http://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Policies/quality_assurance_policies_for_field_laboratories_10_01_2013.pdf - provides clarification to ensure data integrity and defensibility.
Commented [DS91]: Moved to Section .0805 (a) (7) (A) – no
effect
Commented [SD92]: Changed from “a source of distilled or deionized water” to allow labs greater flexibility and to cater to just the analyses under the scope of their accreditation.
Commented [SD93]: Removed the more prescriptive minimum requirements to allow greater flexibility for labs that do not need all of these items to effectively analyze and report the parameters in the scope of their accreditation – potential negative impact.
20

(C) Except for Oil and Grease (EPA Method 413.1), settleable solids or where otherwise 1
specified in an analytical method, analyze five percent of all samples in duplicate to 2
document precision. Laboratories analyzing less than 20 samples per month must 3
analyze at least one duplicate each month samples are analyzed. 4
(D) Any quality control procedures required by a particular approved method shall be 5
considered as required for certification for that analysis. 6
(E) All quality control requirements in these Rules as set forth by the State Laboratory. 7
(F) Any time quality control results indicate an analytical problem, the problem must be 8
resolved and any samples involved must be rerun if the holding time has not expired. 9
(G) All analytical records must be available for a period of five years. Records, which are 10
stored only on electronic media, must be maintained and supported in the laboratory by 11
all hardware and software necessary for immediate data retrieval and review. 12
(H) All laboratories must use printed laboratory bench worksheets that include a space to 13
enter the signature or initials of the analyst, date of analyses, sample identification, 14
volume of sample analyzed, value from the measurement system, factor and final value to 15
be reported and each item must be recorded each time samples are analyzed. The date 16
and time BOD and coliform samples are removed from the incubator must be included on 17
the laboratory worksheet. 18
(I) For analytical procedures requiring analysis of a series of standards, the concentrations of 19
these standards must bracket the concentration of the samples analyzed. One of the 20
standards must have a concentration equal to the laboratory's lower reporting 21
concentration for the parameter involved. For metals by AA or ICP, a series of at least 22
three standards must be analyzed along with each group of samples. For colorimetric 23
analyses, a series of five standards for a curve prepared annually or three standards for 24
curves established each day or standards as set forth in the analytical procedure must be 25
analyzed to establish a standard curve. The curve must be updated as set forth in the 26
standard procedures, each time the slope changes by more than 10 percent at mid-range, 27
each time a new stock standard is prepared, or at least every twelve months. Each analyst 28
performing the analytical procedure must produce a standard curve. 29
(J) Each day an incubator, oven, waterbath or refrigerator is used, the temperature must be 30
checked, recorded, and initialed. During each use, the autoclave maximum temperature 31
and pressure must be checked, recorded, and initialed. 32
(K) The analytical balance must be checked with one class S, or equivalent, standard weight 33
each day used and at least three standard weights quarterly. The values obtained must be 34
recorded in a log and initialed by the analyst. 35
(L) Chemicals must be dated when received and when opened. Reagents must be dated and 36
initialed when prepared. 37
Commented [DS94]: Removed since this is outdated and some
methods require duplicates for these parameters now.
21

(M) A record of date collected, time collected, sample collector, and use of proper 1
preservatives must be maintained. Each sample must clearly indicate the State of North 2
Carolina collection site on all record transcriptions. 3
(N) At any time a laboratory receives samples which do not meet sample collection, holding 4
time, or preservation requirements, the laboratory must notify the sample collector or 5
client and secure another sample if possible. If another sample cannot be secured, the 6
original sample may be analyzed but the results reported must be qualified with the 7
nature of the infraction(s) and the laboratory must notify the State Laboratory about the 8
infraction(s). The notification must include a statement indicating corrective actions 9
taken to prevent the problem for future samples. 10
(O) All thermometers must meet National Institute of Standards and Technology (NIST) 11
specifications for accuracy or be checked, at a minimum annually, against a NIST 12
traceable thermometer and proper corrections made. 13
(7) Analytical Quality Assurance and Quality Control Program. Each laboratory must have a 14
documented analytical quality assurance and quality control program. Each laboratory must have a 15
copy of each approved test, analysis, measurement or monitoring procedure being used in the 16
laboratory. Each laboratory shall develop and maintain documentation outlining the analytical 17
quality control practices used for the Parameter Methods included in their Certification. This must 18
include Standard Operating Procedures for each certified Parameter Method. Quality Assurance, 19
Quality Control and Standard Operating Procedure documentation must clearly indicate the 20
effective date of the document and be reviewed at least every two years and updated as needed. 21
Each laboratory must have a formal process to track and document review dates and any revisions 22
made in all of their Quality Assurance, Quality Control and Standard Operating Procedure 23
documents. Supporting Records shall be maintained as evidence that these practices are being 24
effectively carried out. The Quality Assurance, Quality Control and Standard Operating Procedure 25
documents shall be available for inspection by the State Laboratory. The following are 26
requirements for Certification and must be included in each certified laboratory’s Quality 27
Assurance and Quality Control program. For analysis of Field Parameters, a certified laboratory 28
may follow the quality assurance and quality control requirements in Paragraphs (g) (1) through 29
(9) of this Rule. 30
(A) Unless specified by the method or this Rule, each laboratory must establish acceptance 31
criteria for all Quality Control analyses. Each laboratory must calculate and document the 32
precision and accuracy of all Quality Control analyses with each sample set, where 33
applicable. When the method of choice specifies performance acceptance criteria for 34
precision and accuracy, and the laboratory chooses to develop laboratory-specific limits, 35
the laboratory-specific limits cannot be less stringent than the criteria stated in the 36
approved method. 37
Commented [SD95]: Editorial – added to better characterize the
content of this section of the Rule – no effect
Commented [SD96]: Added language to include terms that
better characterize all parameters that fall under the scope of these
Rules. Clarity – no impact.
Commented [DS97]: Provides clarification for laboratories whose SOPs are not a part of the Quality Assurance Manual – no effect
Commented [DS98]: Provided clarification of the elements of
document control for QA/QC documents for data defensibility purposes and set a timeline for periodic review to ensure these documents are up to date. May have minimal impact in terms of personnel time to review.
Commented [DS99]: Provides clarity – no effect
Commented [DS100]: Added to ensure that laboratories develop quality control practices where none are prescribed by method or Rule. 40 CFR Part 136 requires this, but not all of the programs under the scope of our Rule fall under Clean Water Act requirements. Also, provides consistency across all regulatory programs. May potentially have some impact on some laboratories;
however, most methods have quality control requirements already
prescribed.
Commented [DS101]: Added for clarity - No new requirement
– Has always been enforced using .0805 (a) (7) - Supporting
Records shall be maintained as evidence that these practices are
being effectively carried out.
Commented [DS102]: Provides clarity – Has always been enforced using the method requirement.
22

(B) Any time quality control results fall outside established limits or indicate an analytical 1
problem, the laboratory must take steps to identify the root cause of the failure. The 2
problem must be resolved through corrective action, the process documented and any 3
samples involved must be reanalyzed, if possible. If the sample cannot be reanalyzed, or 4
if the quality control results continue to fall outside established limits or indicate an 5
analytical problem, the results must be appropriately characterized by qualification. 6
(C) Except where otherwise specified in an analytical method, analyze five percent of all 7
samples in duplicate to document precision. Laboratories analyzing less than 20 samples 8
per month must analyze at least one duplicate each month samples are analyzed. 9
(D) Unless the referenced method states a greater frequency or the parameter is not 10
amenable to spiking, spike 5% of samples on a monthly basis. Laboratories analyzing 11
less than 20 samples per month must analyze at least one Matrix Spike each month 12
samples are analyzed. 13
(E) All analytical records, including original observations and information necessary to 14
facilitate historical reconstruction of the calculated results, must be maintained so as to 15
ensure their security and integrity for five years. All analytical data and records pertinent 16
to each certified analysis must be accurate and filed in an orderly manner so as to be 17
readily available for inspection upon request. All analytical records must be legible and 18
safeguarded against unauthorized amendment, obliteration, erasures, overwriting and 19
corruption. Records which are stored only on electronic media must be securely 20
maintained throughout the five year retention period and supported in the laboratory by 21
all hardware and software necessary for immediate data retrieval and review. All 22
documentation errors must be corrected by drawing a single line through the error so that 23
the original entry remains legible. Entries shall not be obliterated by erasures or 24
markings. Wite-Out®, correction tape or similar products designed to obliterate 25
documentation are not to be used. Write the correction adjacent to the error. The 26
correction must be initialed by the responsible individual and the date of change 27
documented. All manual data and log entries must be written in indelible ink. Pencil 28
entries are not acceptable. 29
(F) All laboratories must use printable laboratory benchsheets. Certified Data must be 30
traceable to the associated sample analyses and must consist of the method or Standard 31
Operating Procedure, laboratory identification, instrument identification, sample 32
collector, signature or initials of the analyst, date of collection, time of collection, date of 33
analyses, time of analyses (when required to document a required holding time or when 34
time critical steps are imposed by the method, a federal regulation or this Rule), sample 35
identification, sample preparation where applicable, volume of sample analyzed where 36
applicable, proper units of measure, dilution factor where applicable, all manual 37
Commented [DS103]: Provides clarity – no effect
Commented [DS104]: Provides clarity – no effect
Commented [DS105]: Provides clarity – no effect
Commented [DS106]: Added for clarity - No new requirement – Has always been enforced using .0805 (a) (7) - Supporting Records shall be maintained as evidence that these practices are being effectively carried out.
Commented [DS107]: No new requirement -
https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Policies/Q
ualifyingDataPolicy20110406.pdf
Commented [DS108]: No new requirement -
https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Policies/
Matrix%20Spike%20Policy20120511.pdf
Commented [DS109]: Added for clarity - No new requirement
– Has always been enforced using .0805 (a) (7) - Supporting
Records shall be maintained as evidence that these practices are
being effectively carried out.
Commented [DS110]: Added for clarity – no effect
Commented [DS111]: No new requirement - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Policies/ElectronicDataSstorageAndSignature-20100409-DWQ-LAB-CERT.pdf and provides clarity to current Rule which reads: All analytical records must be available for a period of five years.
Commented [DS112]: No new requirement -
https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Policies/E
rror%20Correction%20Policy.pdf
Commented [DS113]: Changed from “printed” to reduce paper waste and allow laboratories the flexibility of electronic reporting. May potentially save some labs money.
23

calculations, quality control assessments, value from the measurement system, final value 1
to be reported and any other data needed to reconstruct the final calculated result. Each 2
item must be recorded each time samples are analyzed. The date and time samples are 3
placed into and removed from ovens, water baths, incubators and other equipment must 4
be documented where a time limit is imposed by the method. 5
(G) When certified for total suspended residue, total dissolved residue and/or total residue, 6
laboratories must analyze one standard monthly during each month samples are analyzed. 7
(H) For analytical procedures requiring analysis of a series of standards, the concentrations of 8
these standards must bracket the range of the sample concentrations measured. One of the 9
standards must have a concentration equal to or less than the laboratory’s lowest 10
reporting concentration for the parameter involved. All data sets must reference the 11
corresponding calibration. Analyze and/or back-calculate a standard at the same 12
concentration as the lowest reporting concentration each day samples are analyzed. A 13
calibration blank and calibration verification standard must be analyzed initially (prior to 14
sample analysis), after every tenth sample and at the end of each sample group, unless 15
otherwise specified by the method, to check for carry over and calibration drift. 16
(i) The concentration of reagent, method and calibration blanks must not exceed 17
50% of the lowest reporting concentration or as otherwise specified by the 18
reference method. 19
(ii) Analyze one known second source standard to verify the accuracy of standard 20
preparation whenever an initial calibration is performed and in accordance with 21
the referenced method requirements thereafter. 22
(iii) For electrode analyses, a minimum two-point calibration is required. 23
(iv) For metals analyses, a series of at least three non-zero standards or standards as 24
set forth in the analytical procedure must be analyzed along with each sample 25
set. 26
(v) For colorimetric analyses, a series of at least five non-zero standards for a curve 27
prepared every twelve months or three non-zero standards for curves established 28
each day or standards as set forth in the analytical procedure must be analyzed to 29
establish a calibration curve. A manufacturer’s factory-set calibration (internal 30
curve) must be verified with the same number of standards and frequency as a 31
prepared curve. 32
(vi) For ion chromatographic analyses, a series of at least five non-zero standards for 33
a curve prepared every twelve months or three non-zero standards for curves 34
established each day or standards as set forth in the analytical procedure must be 35
analyzed to establish a calibration curve. 36
Commented [DS114]: Added specific items for clarity – no
new requirement – Has always been enforced using .0805 (a) (7) -
Supporting Records shall be maintained as evidence that these
practices are being effectively carried out.
Commented [DS115]: Provides clarity – no effect
Commented [DS116]: Provides clarity - No new requirement -
Has always been enforced using .0805 (a) (7) - Supporting Records
shall be maintained as evidence that these practices are being effectively carried out.
Commented [DS117]: Added to ensure accurate and legally defensible data at the lower reporting concentration – May
potentially impact some labs that cite methods that do not already
require this, but adding the option to back-calculate rather than
analyze a standard alleviates that impact in some cases.
Commented [DS118]: No new requirement -
https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Policies/Calibration%20Verification%20Mid.%20Std.%20and%20Blk%20After%2010%20Policy02_2014.pdf
Commented [DS119]: No new requirement -
https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Policies/B
lankAcceptanceCriterion50Policy02_14.pdf
Commented [DS120]: No new requirement - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Policies/Second%20Source%20Standard%20Policy-20100708-DWQ-LAB-CERT.pdf
Commented [DS121]: Adds clarity – no effect
Commented [DS122]: Added clarity – no effect
Commented [DS123]: Provides clarity by addressing new technology and equipment that have factory-set calibrations.
Commented [DS124]: Provides clarity by specifically
addressing this technology – no effect
24

(I) Each day, of normal business operations, samples are placed into or removed from an 1
incubator, oven, water bath, refrigerator or other temperature controlled device, the 2
temperature must be checked, recorded, dated and initialed. If a method requires more 3
frequent monitoring, the method must be followed. During each use, proper operation of 4
the autoclave must be verified and adequate temperature and pressure, cycle time and 5
items autoclaved must be checked, recorded, dated and initialed. 6
(J) The analytical balance must be checked with one ASTM Type 1, Class 1 or 2, or 7
equivalent standard weight each day used. These weights must be verified at least every 8
five years. Verify the analytical balance with at least three ASTM Type 1, Class 1 or 2, 9
or equivalent standard weights across the range of use monthly. The values obtained must 10
be recorded, dated and initialed. Laboratory analytical balance(s) must be serviced by a 11
metrology vendor/technician at a minimum every 12 months to verify that the balance is 12
functioning within manufacturer’s specifications. 13
(K) Chemical containers must be dated when received and when opened. Reagent containers 14
must be dated, identified and initialed when prepared. Chemicals and reagents exceeding 15
the expiration date cannot be used. The laboratory must have a documented system of 16
traceability for all chemicals, reagents, standards and consumables. 17
(L) A record of date collected, time collected, sample collector, and use of proper 18
preservatives and preservation techniques must be maintained. Each North Carolina 19
sample must clearly indicate the collection site on all record transcriptions. 20
(M) Sample preservation must be verified and documented. At any time a laboratory receives 21
samples subject to G.S. 143-215.1 and 143-215.63, et seq. which do not meet sample 22
collection, holding time, or preservation requirements, the laboratory must document the 23
incident, notify the sample collector or client and secure another sample, if possible. If 24
another viable sample cannot be secured, the original sample may be analyzed but the 25
results reported must be qualified with the nature of the infraction(s) and the laboratory 26
must notify the State Laboratory of the infraction(s). The notification must include a 27
statement indicating corrective action taken to prevent the problem for future samples. 28
(N) All temperature sensing devices must meet National Institute of Standards and 29
Technology (NIST) specifications for accuracy or be checked, at a minimum every 30
twelve months, against a NIST traceable, or equivalent, temperature sensing device and 31
proper corrections made. Temperature sensing devices used only to verify other 32
laboratory temperature sensing devices may be checked every 5 years against a NIST 33
traceable, or equivalent, temperature sensing device and proper corrections made. All 34
temperature sensing devices must have accuracy appropriate for its intended use. All 35
temperature sensing devices must be properly used, stored and maintained. 36
Commented [DS125]: This alleviates the burden of staffing on
weekends – may potentially have a negative impact on labs
Commented [SD126]: Provides clarity – no effect
Commented [SD127]: Provides clarity - No new requirement - Has always been enforced using .0805 (a) (7) - Supporting Records shall be maintained as evidence that these practices are being
effectively carried out.
Commented [SD128]: Updated to current weight classifications – no effect
Commented [SD129]: Added to ensure accurate and legally defensible data – May potentially impact some labs; however,
vendors will often provide this service at no charge.
Commented [SD130]: Increased the frequency of balance
checks across the range of use from quarterly to monthly to ensure
accurate and legally defensible data. Minimal effect since the
weights are already on hand.
Commented [SD131]: No new requirement - https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Policies/A
nalytical%20Balance%20Service%20Policy.pdf
Commented [SD132]: Added “containers” to provide clarity –
no effect
Commented [SD133]: Added “containers” to provide clarity – no effect
Commented [SD134]: Added to provide clarity – no effect
Commented [SD135]: Added to provide clarity – no effect
Commented [SD136]: Provides clarity - No new requirement -
Has always been enforced using .0805 (a) (7) - Supporting Records
shall be maintained as evidence that these practices are being
effectively carried out.
Commented [SD137]: Added to provide clarity – no effect
Commented [SD138]: Provides clarity – no effect
Commented [SD139]: Provides clarity - No new requirement - Has always been enforced using .0805 (a) (7) - Supporting Records shall be maintained as evidence that these practices are being effectively carried out.
Commented [SD140]: Changed from “thermometers” to cover
other technologies used to sense temperature to ensure accurate and
legally defensible data – provides clarity – no effect
Commented [SD141]: Changed from “annually” to provide clarity – no effect
Commented [SD142]: Added a less frequent requirement for limited use thermometers to alleviate burden on labs – May potentially have a negative impact on some labs.
Commented [SD143]: Added for clarity – no new
requirement – enforced by 15A NCAC 2H .0805 (a) (6) (H) -
Glassware, chemicals, supplies, and equipment required to
perform all analytical procedures included in their certification.
25

(O) Mechanical volumetric liquid-dispensing devices (e.g., fixed and adjustable auto-1
pipettors, bottle-top dispensers, etc.), used for critical volume measurements, must be 2
calibrated at least once every six months. 3
(P) Each laboratory must develop and implement a documented training program which 4
includes, at a minimum, documentation of the following: 5
(i) staff have the appropriate education, training, experience and/or demonstrated skills, 6
as required to generate quality control results within method-specified limits 7
and/or that meet the requirements of these Rules; 8
(ii) staff have read the laboratory Quality Assurance Manual and/or applicable Standard 9
Operating Procedures; 10
(iii) staff have obtained acceptable results on unknown performance evaluation samples 11
or other demonstrations of proficiency. 12
(8) Decertification Requirements. Municipal and industrial laboratories that cannot meet initial 13
certification requirements must comply with the Decertification Requirements as set forth in Rule 14
.0807(e) of this Section. 15
(b) Issuance of Certification. 16
(1) Upon compliance with these Rules, certificationCertification shall be issued by the Director, 17
Division of Water Quality, Department of Environmental Quality or his assigned delegate, for 18
each of the applicable parameters Parameter Methods requested within 30 days of receipt of the 19
initial Certification invoice payment. 20
(2) Initial certificationsCertifications shall be valid for the remainder of the applicable Certification 21
cycle. issued for prorated time periods to schedule all certification renewals on the first day valid 22
for one year. 23
(c) Maintenance of Certification. 24
(1) To maintain certificationCertification for each parameter Parameter Method, a certified laboratory 25
must analyze up to four performance evaluation a minimum of one Proficiency Testing sample 26
samples per parameter Parameter Method per yearyear. submitted by an accredited vendor as an 27
unknown. Laboratories submitting unacceptable results on a performance evaluation samples may 28
be required to analyze more than four samples per year.A laboratory may be asked to analyze 29
additional Proficiency Testing samples for a Parameter Method whenever a question about the 30
accuracy of data produced arises, when there are changes in equipment or personnel, when 31
inaccurate information is reported with Proficiency Testing results, or when Unacceptable 32
Proficiency Testing results are submitted. 33
(2) In addition, if a Proficiency Testing sample is not readily available, the State Laboratory may 34
request the analysis of Split samples, that samples be split into two equal representative portions, 35
one part going to the State and the other to the certified laboratory for analysis.Acceptable Split 36
Commented [SD144]: No new requirement -
https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Policies/P
ipettor%20Calibration%20Policy%20-%2003_09.pdf
Commented [SD145]: Added to ensure accurate and legally
defensible data – should have minimal effect since it is
documentation-oriented
Commented [SD146]: Removed obsolete language that was
meant to grandfather labs in when the Rules were originally written–
not necessary
Commented [SD147]: Provides clarification – no effect
Commented [SD148]: Simplified language for clarity – no effect
Commented [SD149]: Reworded to provide clarification – many stakeholders thought this meant they had to analyze 4 samples per year – no new requirement
26

sample results will be determined by the State Laboratory using scientifically valid statistical 1
methodology. 2
(3) The State laboratory may submit or require clientscertified laboratories to submitanalyze blind 3
performance Proficiency Testing samples or splitSplit samples under direction of State Laboratory 4
personnel. 5
(4) A certified laboratory shall be subject to periodic announced or unannounced inspections during 6
the certificationCertification period and shall make time and all relevant records available for 7
inspections inspection. and must supply copies of records for any investigation upon written 8
request by the State Laboratory. 9
(5) A certified laboratory must provide the State Laboratory with written notice of laboratory 10
supervisor or laboratory manager changes within 30 days of such changes. 11
(6) A certified laboratory must submit written notice of any changes of location, ownership, address, 12
name or telephone number within 30 days of such changes. 13
(7) A certified laboratory must submit a written amendment to the certification application each time 14
that changes occur in methodology, reporting limits, and major equipment. The amendment must 15
be received within 30 days of such changes. 16
(5) A certified laboratory must supply copies of all relevant records for any investigation upon written 17
request by the State Laboratory. 18
(6) A certified laboratory must provide the State Laboratory with written notice of laboratory 19
supervisor or laboratory manager changes within 30 days of such changes. 20
(7) A certified laboratory must submit written notice of any changes of location, ownership, address, 21
name, or telephone number within 30 days of such changes. 22
(d) Certification Renewals Renewals. 23
(1) Certification renewals of laboratories shall be issued for one year. 24
(e) Data reporting.Reporting. 25
(1) Certified commercial laboratoriesCommercial Laboratories must provide make data reports to 26
their clients that are signed by the laboratory supervisor. This duty may be delegated in writing; 27
however, the responsibility shall remain with the supervisor. 28
(2) Whenever a certified commercial laboratoryLaboratory refers or subcontracts samples to another 29
laboratory certified laboratory for analyses, the Parameter, the referring laboratory must supply the 30
date and time samples were collected to insure holding times are met. Subcontracted samples must 31
clearly indicate the State of North Carolina as the collection site on all record transcriptions. 32
Laboratories may subcontract sample fractions, extracts, leachates and other sample preparation 33
products provided that evidence of adherence to all Rules and requirements of 15A NCAC 02H 34
.0800 areis documented. The initial client requesting the analyses must receive the original or a 35
copy of the report made by the laboratory that performs the analyses. Each reported result must be 36
unequivocally traceable to the laboratory that performed the analysis on the final report. 37
Commented [SD150]: Reworded to provide clarification – no
new requirement
Commented [SD151]: Reworded for clarity – no new
requirement
Commented [SD152]: Reworded for clarity – no new requirement
Commented [SD153]: Moved to .0805 (c) (6)
Commented [SD154]: Moved to .0805 (c) (7)
Commented [SD155]: Removed – not necessary
Commented [SD156]: Changed from “amendment” so as not to imply they must complete an amendment form. Reduces paper waste and burden.
Commented [SD157]: Removed "Commercial" to clarify that
any certified laboratory may refer or subcontract samples to another
certified laboratory
Commented [SD158]: grammatical correction - no effect
Commented [SD159]: Provides clarity – no effect
27

(3) All uncertified dataUncertified Data must be clearly documented as such on the benchsheet and on 1
the final report. 2
(4) Sample results reported below the lowest reporting concentration, if required by the data receiver, 3
must be appropriately characterized as an estimated value by qualification. 4
(5) Reported data associated with Quality Control failures, improper sample collection, holding time 5
exceedances or improper preservation must be appropriately characterized by qualification. 6
(f) Discontinuation of Certification. 7
(1) A laboratory may discontinue certificationCertification for any or all parametersParameter 8
Methods by making a written request to the State Laboratory. 9
(2) After discontinuation of certification,Certification, a laboratory may be recertified by meeting the 10
requirements for initial certification;Certification; however, laboratories that discontinue 11
certificationCertification during any investigation shall be subject to Rule .0808 of this Section. 12
(g) Prerequisites and Requirementsrequirements for Field Laboratory Parameter Certification. Only the following 13
requirements must be met prior to certificationCertification for Field Parameter Laboratories. Once certified, failure 14
to comply with any of the following items will be a violation of certificationCertification requirements. 15
(1) Data pertinent to each analysis must be maintained for five years. Certified Data must consist of 16
date collected, time collected, sample site, sample collector, and sample analysis time. The field 17
benchsheets must provide a space for the signature or initials of the analyst, and proper units of 18
measure for all analyses. 19
(2) A record of instrument calibration where applicable, must be filed in an orderly manner so as to be 20
readily available for inspection upon request. 21
(3) A copy of each approved analytical procedure must be available to each analyst. 22
(4) Each facility must have glassware, chemicals, supplies, equipment, and a source of distilled or 23
deionized water that will meet the minimum criteria of the approved methodologies. 24
(5) Supervisors of laboratories certified for Field Parameters only must meet the requirements of 25
Subparagraph (a)(3)(A) or (a)(3)(B) of this Section, or possess a chemistry or related degree with 26
two years of related environmental experience, or hold any Biological Water Pollution Control 27
System Operator's Certification as defined by 15A NCAC 08G. 28
(6) Application: Each Field Parameter Laboratory shall submit an application in duplicate. 29
(7) Performance Evaluations. Each Field Parameter Laboratory must participate in an annual quality 30
assurance study by analyzing performance evaluation samples obtained from an accredited vendor 31
as unknowns. If performance evaluations are not available for a parameter, certification for that 32
parameter may be based on the proper use of the approved procedure as determined by an 33
announced or unannounced on-site inspection. 34
(8) Decertification and Civil Penalties. A laboratory facility can be decertified for infractions as 35
outlined in Rule .0807 of this Section. 36
Commented [SD160]: Added to ensure accurate and legally
defensible data – this is an industry standard – added for clarity since
there are a few states/programs that do not require this – no effect
Commented [SD161]: No new requirement - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Policies/Q
ualifyingDataPolicy20110406.pdf
28

(9) Recertification. A laboratory facility can be recertified in accordance with Rule .0808 of this 1
Section. 2
(1) All analytical records, including original observations and information necessary to facilitate 3
historical reconstruction of the calculated results, must be maintained so as to ensure their security 4
and integrity for five years. All analytical data and records pertinent to each certified analysis must 5
be accurate and filed in an orderly manner so as to be readily available for inspection upon 6
request. All analytical records must be legible and safeguarded against unauthorized amendment, 7
obliteration, erasures, overwriting and corruption. Records which are stored only on electronic 8
media must be securely maintained throughout the five year retention period and supported in the 9
laboratory by all hardware and software necessary for immediate data retrieval and review. All 10
documentation errors must be corrected by drawing a single line through the error so that the 11
original entry remains legible. Entries shall not be obliterated by erasures or markings. Wite-12
Out®, correction tape or similar products designed to obliterate documentation are not to be used. 13
Write the correction adjacent to the error. The correction must be initialed by the responsible 14
individual and the date of change documented. All manual data and log entries must be written in 15
indelible ink. Pencil entries are not acceptable. 16
(2) All laboratories must use printable laboratory benchsheets. Certified Data must be traceable to the 17
associated sample analyses and must consist of the method or Standard Operating Procedure, 18
laboratory identification, instrument identification, sample collector, signature or initials of the 19
analyst, date of collection, time of collection, date of analyses, time of analyses (when required to 20
document a required holding time or when time critical steps are imposed by the method, a federal 21
regulation or this Rule), sample identification, sample preparation where applicable, volume of 22
sample analyzed where applicable, proper units of measure, dilution factor where applicable, all 23
manual calculations, quality control assessments, value from the measurement system, final value 24
to be reported and any other data needed to reconstruct the final calculated result. Each item must 25
be recorded each time samples are analyzed. Analyses must conform to methodologies found in 26
Rule .0805 (a) (1) of this Section. 27
(3) A record of instrument calibration or calibration verification, where applicable, must be 28
documented and filed in an orderly manner so as to be readily available for inspection upon 29
request. 30
(4) Laboratory Procedures. Laboratory procedures must be in accordance with Rule .0805 (a) (1) of 31
this Section. A copy of each analytical method and/or Approved Procedure and Standard 32
Operating Procedure must be available to each analyst and available for review upon request by 33
the State Laboratory. Standard Operating Procedure documentation must clearly indicate the 34
effective date of the document and must be reviewed at least every two years and updated as 35
needed. Each laboratory must have a formal process to track and document review dates and any 36
Commented [SD162]: Expanded to provide clarity and consistency with Non-field lab rule – no effect - Data pertinent to each analysis must be maintained for five years.
Commented [SD163]: No new requirement -
http://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Policies/q
uality_assurance_policies_for_field_laboratories_10_01_2013.pdf
Commented [SD164]: Expanded to provide clarity – No new
requirement - Has always been enforced using .0805 (g) (1) - Data
pertinent to each analysis must be maintained for five years.
Certified Data must consist of date collected, time collected, sample
site, sample collector, and sample analysis time. The field
benchsheets must provide a space for the signature or initials of the
analyst, and proper units of measure for all analyses.
Commented [SD165]: Provides clarity – no effect
Commented [SD166]: Gives greater flexibility to use
procedures developed by Certification and based on approved
reference methods – May potentially have a negative impact on
some laboratories since it may alleviate having to purchase reference
methods.
29

revisions made in all of their Standard Operating Procedure documents. Supporting Records shall 1
be maintained as evidence that these practices are being effectively carried out. 2
(5) Each laboratory must develop and implement a documented training program which includes, at a 3
minimum, documentation of the following: 4
(i) staff have the appropriate education, training, experience and/or demonstrated 5
skills, as required to generate quality control results within method-specified 6
limits and/or that meet the requirements of these Rules; 7
(ii) staff have read the laboratory Quality Assurance Manual and/or applicable 8
Standard Operating Procedures; 9
(iii) staff have obtained acceptable results on unknown performance evaluation 10
samples or other demonstrations of proficiency. 11
(6) Each facility must have glassware, chemicals, supplies, properly maintained equipment, and a 12
source of water that will meet the minimum criteria of the approved methodologies. A best effort 13
must be made to perform analyses in a manner where possible sources of contamination or error 14
will not be introduced. 15
(7) Chemical containers must be dated when received and when opened. Reagent containers must be 16
dated, identified and initialed when prepared. Chemicals and reagents exceeding the expiration 17
date cannot be used. Chemicals and reagents must be assigned expiration dates by the laboratory if 18
not given by the manufacturer. If the laboratory is unable to determine a proper expiration date for 19
a particular chemical reagent, a one-year time period from the date of receipt shall be deemed 20
acceptable unless degradation is observed prior to this date. The laboratory must have a 21
documented system of traceability for all chemicals, reagents, standards and consumables. 22
(8) Any time quality control results fall outside established limits or indicate an analytical problem, 23
the laboratory must take steps to identify the root cause of the failure. The problem must be 24
resolved through corrective action, the process documented and any samples involved must be 25
reanalyzed, if possible. If the sample cannot be reanalyzed or if the quality control results continue 26
to fall outside established limits or indicate an analytical problem, the results must be 27
appropriately characterized by qualification. 28
(9) All temperature sensing devices must meet National Institute of Standards and Technology (NIST) 29
specifications for accuracy or be checked, at a minimum every twelve months, against a NIST 30
traceable, or equivalent, temperature sensing device and proper corrections made. Temperature 31
sensing devices used only to verify other laboratory temperature sensing devices may be checked 32
every 5 years against a NIST traceable, or equivalent, temperature sensing device and proper 33
corrections made. All temperature sensing devices must have accuracy appropriate for its intended 34
use. All temperature sensing devices must be properly used, stored and maintained. 35
(10) Mechanical volumetric liquid-dispensing devices (e.g., fixed and adjustable auto-pipettors, bottle-36
top dispensers, etc.) must be calibrated at least once every twelve months. 37
Commented [SD167]: Added to ensure accurate and legally
defensible data and to be consistent with Non-field lab requirements
– Minimal effect is anticipated – our program intends to help with
this by providing SOP templates for the Field Parameters.
Commented [SD168]: Added to ensure accurate and legally defensible data – should have minimal effect since it is documentation oriented.
Commented [SD169]: Added for clarity – no effect
Commented [SD170]: No new requirement -
http://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Policies/q
uality_assurance_policies_for_field_laboratories_10_01_2013.pdf
Commented [SD171]: No new requirement - http://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Policies/quality_assurance_policies_for_field_laboratories_10_01_2013.pdf
Commented [SD172]: No new requirement -
http://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Policies/q
uality_assurance_policies_for_field_laboratories_10_01_2013.pdf
Commented [SD173]: Added to ensure accurate and legally
defensible data – May potentially impact some laboratories if they
choose to have a vendor verify traceability.
Commented [SD174]: No new requirement - http://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Policies/quality_assurance_policies_for_field_laboratories_10_01_2013.pdf
30

(11) Supervisors of laboratories certified for Field Parameters only must meet the requirements of 1
Subparagraph (a) (3) (A) or (a) (3) (B) of this Section, or possess a chemistry or related degree 2
with two years of related environmental experience, or an equivalent combination of education 3
and work experience, or hold any Water Pollution Control System Operator’s Certification as 4
defined by 15A NCAC 08G or subsequent Rules. All laboratory supervisors are subject to review 5
by the State Laboratory. The supervisor shall provide personal and direct supervision of the 6
technical personnel and be held responsible for the proper performance and reporting of all 7
analyses made for these Rules. If the supervisor is to be absent, the supervisor shall arrange for a 8
substitute capable of insuring the proper performance of all laboratory procedures, however, the 9
substitute supervisor cannot be in charge for more than twelve consecutive weeks. 10
(12) A certified Field Laboratory will be subject to periodic announced or unannounced inspections 11
during the Certification period and must make all relevant records available for inspection. 12
(13) A certified Field Laboratory must supply copies of all relevant records for any investigation upon 13
written request by the State Laboratory. 14
(14) A certified Field Laboratory must pay all applicable fees in accordance with Rule .0806 of this 15
Section. 16
(15) Application. Each Field Laboratory requesting initial Certification shall submit an application to 17
the State Laboratory. 18
(16) Proficiency Testing. Each certified Field Laboratory must be in accordance with Rule .0805 (a) (2) 19
of this Section. 20
(17) Data Reporting. Each certified Field Laboratory must be in accordance with Rule .0805 (e) of this 21
Section. 22
(18) Issuance of Certification. A Field Laboratory may be issued Certification in accordance with Rule 23
.0805 (b) of this Section. 24
(19) Maintenance of Certification. A certified Field Laboratory must submit written notice of any 25
material changes in the laboratory supervisor, location, ownership, address, name and telephone 26
number within 30 days of such changes. 27
(20) Certification Renewals. Certification renewals of certified Field Laboratories will be issued in 28
accordance with Rule .0805 (d) of this Section. 29
(21) Discontinuation of Certification. A certified Field Laboratory may discontinue Certification in 30
accordance with Rule .0805 (f) of this Section. 31
(22) Decertification. A certified Field Laboratory may be decertified and must meet all Decertification 32
requirements for infractions in accordance with Rule .0807 of this Section. 33
(23) Civil Penalties. Civil Penalties may be assessed against a certified Field Laboratory which violates 34
or fails to act in accordance with any of the terms, conditions, or requirements of the Rule .0807 of 35
this Section or of the State Laboratory. A laboratory is subject to both civil penalties and 36
Decertification. 37
Commented [SD175]: Reduces regulatory burden – increases
flexibility in meeting Supervisory requirements
Commented [SD176]: Reduces regulatory burden – increases flexibility in meeting Supervisory requirements by allowing Physical/Chemical Operator’s license in addition to the Biological Operator’s license.
Commented [SD177]: Added for clarity – no effect
Commented [SD178]: Made language consistent with Non-
field lab rule – no new requirement .0805 (g) (7) - If performance
evaluations are not available for a parameter, certification for that parameter may be based on the proper use of the approved procedure as determined by an announced or unannounced on-site inspection.
Commented [SD179]: Made language consistent with Non-field lab rule – no new requirement .0805 (g) (2) - A record of instrument calibration where applicable, must be filed in an orderly manner so as to be readily available for inspection upon request.
Commented [SD180]: Provides clarity – no effect
Commented [SD181]: Removed requirement to submit it in duplicate to reduce paper waste
Commented [SD182]: No new requirement -
https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Technical%20Assistance%20Documents/PTRequirementsDocument20120120Revision%201.2F.pdf
Commented [SD183]: Provides clarity – no effect
Commented [SD184]: Provides clarity – no effect
Commented [SD185]: Added this requirement to be consistent
with Non-field lab rule and for tracking purposes– minimal effect
Commented [SD186]: Provides clarity – no effect
Commented [SD187]: Provides clarity – no effect
Commented [SD188]: Expanded to provide clarity – no effect
31

(24) Recertification. A decertified Field Laboratory may be recertified in accordance with Rule .0808 1
of this Section. 2
3
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10)143-215.3(a)(10); 143-215.6A 4
Eff. February 1, 1976; 5
Amended Eff. July 1, 1988; July 1, 1985; December 1, 1984; November 1, 1978; 6
RRC Objection Eff. October 15, 1992 due to lack of statutory authority; 7
Amended Eff. December 21, 1992; 8
RRC Objection Removed Eff. December 16, 1993; 9
Temporary Amendment Eff. October 1, 2001; 10
Amended Eff. August 1, 2002. 11
12
32

15A NCAC 02H .0806 is proposed for readoption : 1
2
15A NCAC 02H .0806 FEES ASSOCIATED WITH CERTIFICATION PROGRAM 3
(a) An applicant for laboratory certification,Certification, excluding those laboratories seeking Field Parameter 4
Certification only, must submit to the Department of Environment and Natural Resources, LaboratoryEnvironmental 5
Quality, Division of Water Resources, Water Sciences Section, a non-refundable fee of three hundred dollars 6
($300.00) for the evaluation and processing of each application. 7
(b) Municipal, Industrial and Other laboratoriesLaboratories must pay an annual fee of fifty dollars ($50.00)eighty-8
five dollars ($85.00) for each inorganic parameter plus one hundred dollars ($100.00) for each organic parameter 9
and metals analyte; however, the minimum fee will be one thousand threeseven hundred fifty dollars 10
($1,350.00)($1750.00) per year. 11
(c) Commercial laboratoriesLaboratories must pay an annual fee of fifty dollars ($50.00)eighty-five dollars ($85.00) 12
for each inorganic parameter plus one hundred dollars ($100.00) for each organic parameter and metals analyte; 13
however, the minimum fee will be twothree thousand sevenfive hundred dollars ($2,700.00)($3500.00) per year. 14
(d) Prior to receiving initial certification,Certification, a Field Laboratory must pay the required fee as specified in 15
Paragraph (k) or (l) of this Rule and all other laboratories laboratory must pay the required fee as specified in 16
Paragraph (b) or (c) of this Rule. Initial certificationExcluding Field Laboratories, Certification fee will be prorated 17
on a semi-annual quarterly basis to make all certificationCertification renewals due on the first day of January. 18
(e) Once certified, a Field Laboratories must pay a fifty dollar ($50.00) administrative fee for each Parameter 19
Method added to their Certified Parameters Listing and all other laboratorieslaboratory must pay the full annual 20
parameter fee for each parameterParameter Method added to their certificate.Certified Parameters Listing. 21
(f) A laboratory decertified for all parameters must pay initial certificationCertification fees prior to 22
recertification.Recertification. 23
(g) A laboratory decertified for one or more parametersParameter Methods must pay a fee of two hundred dollars 24
($200.00) for each parametersParameter Method for which it was decertified prior to recertification.Recertification. 25
(h) Out-of-state laboratories shall reimburse the stateState for actual travel and subsistence costs incurred in 26
certificationCertification and maintenance of certification.Certification. Out-of-state laboratories will also be 27
assessed for expenses for an on-site inspection based on the hourly rate of the laboratory certification officer(s), 28
rounded to the nearest hour and inclusive of preparation time, travel time and inspection time. 29
(i) Annual certificationCertification fees are due 60 days after receipt of invoice. 30
(j) A fifty dollar ($50.00) late payment fee must be paid by Field Laboratories when annual Certification fees are 31
not paid by the date due. AFor all other laboratories, a two hundred fifty dollar ($250.00) late payment fee must be 32
paid when annual certificationCertification fees are not paid by the date due. 33
(k) Commercial facilitiesLaboratories analyzing samples for field parametersField Parameters only must pay an 34
annual fee of twothree hundred dollars ($200.00)($300.00) per year. 35
(l) Municipal and Industrial facilitiesMunicipal, Industrial and Other Laboratories analyzing samples for field 36
parametersField Parameters only must pay an annual fee of one hundred fifty dollars ($100.00)($150.00) per year. 37
Commented [SD189]: We are asking for a modest and what we
feel is a fair fee increase. After no increase in 14 years, receipts no
longer adequately support this program. We are only hoping to
regain the 3 positions that were lost to help provide the oversight and
technical support of over 700 client laboratories. [see attached fee
justification] It should be noted that the increase in annual minimum
fees will only affect laboratories that are above the minimum. The
change in Parameter addition fee is more for some additions and less
for others.
Commented [SD190]: Increases minimum annual fee $400 – changes all Parameter addition fees to $85.00 [currently inorganics were $50 and metals/organics were $100]
Commented [SD191]: Increases minimum annual fee $800 –
changes all Parameter addition fees to $85.00 [currently inorganics
were $50 and metals/organics were $100]
Commented [SD192]: Provides clarity – no effect
Commented [SD193]: Potentially reduces existing impact for new labs that seek certification in the second and fourth quarters of
the year – no effect if adding in first and third quarters.
Commented [SD194]: New requirement to cover administrative fees for processing Parameter additions – May impact a lab only if they add Parameter Method(s).
Commented [SD195]: New requirement – Impacts the lab only
when audited and helps offset a business advantage that out-of-state
labs have over the in-state labs that must pay state taxes.
Commented [SD196]: New requirement – Will only impact laboratories if they do not pay annual fees within 60 days of receipt per .0806 (i).
Commented [SD197]: $100 increase in annual fee for Commercial Field labs
Commented [SD198]: $50 increase in annual fee for Field labs
33

(m) A laboratory that voluntarily discontinues Certification must pay all Certification fees as specified in 1
Paragraphs .0806 (a) (b) (c) (d) (k) or (l) of this Rule prior to regaining Certification. 2
3
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 4
Eff. February 1, 1976; 5
Amended Eff. November 2, 1992; December 1, 1984; 6
Temporary Amendment Eff. October 1, 2001; 7
Amended Eff. August 1, 2002. 8
9
Commented [SD199]: Added to provide clarity – no effect
34

15A NCAC 02H .0807 is proposed for readoption: 1
2
15A NCAC 02H .0807 DECERTIFICATION AND CIVIL PENALTIES 3
(a) Laboratory Decertification. A laboratory may be decertified, for any or all parameters, for up to one year for 4
any of the following infractions:The following infractions may result in a laboratory being decertified for any or all 5
parameters for up to one year: 6
(1) Failing to maintain the facilities, or records, or personnel, or equipment, or quality control 7
program as set forth in the application, and these Rules; or 8
(2) Submitting inaccurate data or other information; or 9
(3) Failing to pay required fees by the date due; or 10
(4) Failing to discontinue supplying data for clients or programs described in Rule .0802 of this 11
Section during periods when a decertificationDecertification is in effect; or 12
(5) Failing to submit a splitSplit sample to the State Laboratory as requested; or 13
(6) Failing to use approved methods of analysis; or 14
(7) Failing to report laboratory supervisor or equipment changes within 30 days of such changes; or 15
(8) Failing to report analysis of required annual performance evaluation Proficiency Testing samples 16
submitted by an aEPA State Laboratory approved vendorVendor within the specified time limit; or 17
(9) Failing to allow an inspection by an authorized representative of the State Laboratory; or 18
(10) Failing to supply all records and analytical data requested by the State Laboratory; or 19
(11) Failing to submit a written notification amendment to the certification application within 30 days 20
of applicable changes; or 21
(12) Failing to meet required requirements for sample holding times and preservation; or 22
(13) Failing to respond to requests for information by the date due; or 23
(14) Failing to comply with any other terms, conditions, or requirements of this Section or of a 24
laboratory certificationCertification; 25
(15) Altering or modifying the laboratory’s certificate or Certified Parameters Listing; 26
(16) Sharing or conferring Proficiency Testing sample results with other laboratories prior to the study 27
reporting deadline; 28
(17) Splitting, sending, or subcontracting a Proficiency Testing sample or a portion of a Proficiency 29
Testing sample, to another laboratory for any analysis for which it is certified or seeking 30
Certification unless the practice represents the routine analysis and reporting scheme utilized by 31
the laboratory; 32
(18) Knowingly receiving and analyzing any Proficiency Testing sample or portion of a Proficiency 33
Testing sample from another laboratory for which the results of the Proficiency Testing sample are 34
intended for use for initial or continued Certification. 35
(19) Obtaining or attempting to obtain the assigned value of any Proficiency Testing sample used to 36
satisfy initial or continued Certification requirements prior to the closing date of the study. 37
Commented [SD200]: Editorial – no new requirement added
Commented [SD201]: Removed – not necessary – reduces
burden on labs
Commented [SD202]: Technical correction - EPA no longer
approved PT vendors – no effect
Commented [SD203]: Capitalized a defined term for clarity - no effect.
Commented [SD204]: Provides clarification that records other than just the analytical data itself apply – No effect
Commented [SD205]: Allows for any form of written
notification of including electronic to reduce burden on the labs
Commented [SD206]: Clarification – both preservation and holding time are requirements across all regulatory programs – no
effect
Commented [SD207]: Provides clarity – falsification - Ensures
laboratories do not misrepresent their scope of accreditation to
stakeholders, clients and data receiving agencies – no impact
Commented [SD208]: Ensures accurate representation of a laboratory’s proficiency and that no bias is contributed to the reported results – no new requirement added - https://ncdenr.s3.amazonaws.com/s3fs-public/Water%20Quality/Chemistry%20Lab/Certification/Technical%20Assistance%20Documents/PTRequirementsDocument20120120Revision%201.2F.pdf
35

(20) Failing to correct findings in an inspection report. 1
(b) Parameter Method Decertification. A laboratory may receive a parameter decertification for failing to:The 2
laboratory may be decertified for a Parameter Method for: 3
(1) Obtain acceptable results on two consecutive blind or announced performance evaluation samples 4
submitted by an EPA accredited vendor or the State Laboratory; orObtaining two consecutive 5
Unacceptable Proficiency Testing sample results; or 6
(2) Obtain acceptable results on two consecutive blind or announced split samples that have also been 7
analyzed by the State Laboratory.Obtaining two consecutive unacceptable Split sample results. 8
(c) Falsified Data. A laboratory that submits falsified data or other information may be decertified for all 9
parameters for up to two years.years and may be recertified per Rule .0808 of this Section. 10
(d) Decertification Factors. In determining a period of decertification,Decertification, the Director shall recognize 11
that any harm to the natural resources of the State arising from violations of thesethe Rules in this Section may not 12
be immediately observed and may be incremental or cumulative with no damage that can be immediately observed 13
or documented. Decertification for periods up to the maximum may be based on any andone or a combination of the 14
following factors to be considered:factors set forth at G.S. 143B-282.1(b). 15
(1) The degree and extent of harm, or potential harm, to the natural resources of the State or to the 16
public health, or to private property resulting from the violation; 17
(2) The duration, and gravity of the violation; 18
(3) The effect, or potential effect, on ground or surface water quantity or quality or on air quality; 19
(4) Cost of rectifying any damage; 20
(5) The amount of money saved by noncompliance; 21
(6) As to violations other than submission of falsified data or other information, whether the violation 22
was committed willfully or intentionally; 23
(7) The prior record of the laboratory in complying or failing to comply with any State andand/or 24
Federal laboratory Rules and regulations; 25
(8) The cost to the State of investigation and enforcement procedures; 26
(9) Cooperation of the laboratory in discovering, identifying, or reporting the violation; 27
(10) Measures the laboratory implemented to correct the violation or abate the effect of the violation, 28
including notifying any affected clients; 29
(11) Measures the laboratory implemented to correct the cause of the violation; 30
(12) Any other relevant facts. 31
(e) Decertification Requirements. 32
(1) A decertified laboratory is not to analyze samples for the decertified parametersParameter Method 33
for programs described in Rule .0802 of this Section or clients reporting to these programs or other 34
programs requiring Certified Data pursuant to this Section. 35
(2) A decertified commercial laboratoryCommercial Laboratory must supply written notification of 36
the decertificationDecertification to clients with Division of Water Quality Department of 37
Commented [SD209]: Ensures data is of known and
documented quality and that all requirements of 15A NCAC 2H
.0800 are met – no effect
Commented [SD210]: Added the “Parameter Method” distinction to reduce regulatory burden on laboratories. Would only be decertified for a single method when a lab is certified for multiple methods under one parameter category. Currently wording required
all methods would be decertified for that parameter category. Potential negative impact.
Commented [SD211]: Editorial – no effect
Commented [DS212]: Adds clarification – no effect
Commented [SD213]: Covered in the G.S. - unnecessary and duplicative - no effect
Commented [DS214]: Provides clarification – no effect
36

Environmental Quality reporting requirements. Within 30 days, the decertified laboratory must 1
supply the State Laboratory with a list of clients involved and copies of the notices sent to each. 2
(3) A commercial laboratoryCommercial Laboratory that has received a parameter 3
decertificationParameter Method Decertification may make arrangements to supply analysis 4
through another certified laboratory certified by the State Laboratory for the contracted parameters 5
during any decertificationDecertification periods. The decertified laboratory must supply the State 6
Laboratory, by written notice, the name of the laboratory to be used. Within 30 days the 7
decertified laboratory must supply the State Laboratory with a list of clients involved, copies of 8
the notices sent to each, and the name and Certification number of the certified laboratory(ies) to 9
be used during the Decertification period. 10
(4) A commercial laboratoryCommercial Laboratory decertified for all parameters cannot subcontract 11
samples for analyses to other certified laboratories during the decertificationDecertification period. 12
(5) A decertified municipal or industrial laboratory Municipal or Industrial Laboratory that has 13
received a Parameter Method Decertification must have its samples requiring that Parameter 14
Method analyzed by another certified laboratory certified by the State Laboratory for the 15
contracted Parameter Method during any decertificationDecertification period and supply the State 16
Laboratory, by written notice, the name of the certified laboratory to be used. Within 30 days, the 17
decertified laboratory must supply the State Laboratory with the name and Certification number of 18
the certified laboratory(ies) to be used during the Decertification period. 19
(f) Civil Penalties. Civil penalties may be assessed against a laboratory which violates or fails to act in accordance 20
with any of the terms, conditions, or requirements of the Rules in this Section. or of a laboratory certification. A 21
laboratory is subject to both civil penalties and decertification.Decertification. 22
23
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 143-215.6A; 24
Eff. February 1, 1976; 25
Amended Eff. November 2, 1992; December 1, 1984; 26
Temporary Amendment Eff. October 1, 2001; 27
Amended Eff. August 1, 2002. 28
29
Commented [DS215]: Provides clarification – no effect
Commented [DS216]: Added additional information we ask for when a lab is decertified – no new requirement – see LC-22 Form
Commented [DS217]: Editorial – no effect
Commented [DS218]: Added additional information we ask for when a lab is decertified – no new requirement – see LC-22 Form
Commented [DS219]: Removed redundant language – no effect
37

15A NCAC 02H .0808 is proposed for readoption: 1
2
15A NCAC 02H .0808 RECERTIFICATION 3
(a) A laboratory decertified in accordance with Paragraph (a) of Rule .0807 of this Section mayshall be recertified 4
at the end of the Decertificationdecertification period imposed by the Division pursuant to 15A NCAC 02H .0807 5
(a) and (d) by showing to the satisfaction of the State Laboratory that it has corrected the 6
deficiency(ies).deficiency(ies) on the basis for which it was decertified. 7
(b) A laboratory decertified for a parameter due to unacceptable results on two consecutive performance evaluation 8
samples submitted by an EPA accredited vendor, or on two consecutive split samples may be recertified after 60 9
days by reporting acceptable results on two consecutive performance evaluation samples submitted by an EPA 10
accredited vendor. Recertification samples may be requested from an EPA accredited vendor at any time, however, 11
recertification must be requested in writing at the end of the 60 day period immediately following the date of 12
decertification. 13
(c) A laboratory decertified for submitting falsified data or other information may be recertified at the end of the 14
decertification period by demonstrating compliance with all requirements of this Section. 15
(b) A laboratory decertified for a Parameter Method due to two consecutive Unacceptable Proficiency Testing 16
results, or on two consecutive Split samples may be recertified at the end of the 30-day period by completing all of 17
the following: 18
(1) Report acceptable results on two consecutive Proficiency Testing samples submitted by a State 19
Laboratory approved Vendor or report acceptable results on two consecutive samples split with 20
the State Laboratory. Recertification samples may be requested from a State Laboratory approved 21
Vendor at any time; 22
(2) Recertification must be requested in writing following Decertification; 23
(3) The decertified laboratory must supply the State Laboratory with the completed decertified laboratory 24
report form sent with the Decertification notice; 25
(4) The decertified laboratory must supply the State Laboratory with a report of the investigation of the 26
root cause and corrective action taken; 27
(5) The laboratory must pay the required fee as specified in Rule .0806 (f) or (g) of this Section; and 28
(6) The laboratory has met all of the Decertification requirements in accordance with Paragraph .0807 (e) 29
of this Section. 30
(c) After two years, a Parameter Method Recertification will be treated as an initial Certification in accordance with 31
Rule .0805 of this Section. 32
(d) A laboratory decertified for submitting Falsified Data or Information may be recertified at the end of the 33
Decertification period imposed by the Division pursuant to 15A NCAC 02H .0807 (c) and (d) by demonstrating 34
compliance with all requirements of this Section. 35
36
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 37
Commented [DS220]: Provides clarification – no effect
Commented [SD221]: Provides clarification - no effect
Commented [SD222]: Reducing the decertification period for
unacceptable PT results reduces the burden on laboratories by
reducing the amount of time they would have to subcontract or
contract analyses during the decertification period. Potential
negative impact on laboratories if they are decertified.
Commented [DS223]: No new requirement -
https://ncdenr.s3.amazonaws.com/s3fs-
public/Water%20Quality/Chemistry%20Lab/Certification/Technical
%20Assistance%20Documents/PTRequirementsDocument20120120
Revision%201.2F.pdf
Commented [DS224]: Provides clarification – no effect
Commented [DS225]: Added because personnel, equipment, methodology, etc. often change in this time period. Having to submit application after this point will ensure this information is captured and potentially reduces burden on the lab because they would only need to supply one PT result to regain certification and would not be charged the $00 recertification fee.
Commented [DS226]: This rule was simply re-lettered – no
effect
38

Eff. February 1, 1976; 1
Amended Eff. November 2, 1992; December 1,1984; 2
Temporary Amendment Eff. October 1, 2001; 3
Amended Eff. August 1, 2002. 4
5
39

15A NCAC 02H .0809 is proposed for readoption : 1
2
15A NCAC 02H .0809 RECIPROCITY 3
(a) Laboratories certified under other state certification programs and/or certification (accreditation) bodies may be 4
given reciprocityreciprocal certificationCertification where such programs and/or certification (accreditation) bodies 5
meet the requirements of this Section. In requesting reciprocity certification,Certification, laboratories shall include 6
with the application required by Rule .0805(a) of this Section a copy of their certification, a copy of the last audit 7
report from the certifying agency, the laboratory’s response to the audit report, the laboratory’s scope of 8
accreditation and RegulationRegulation(s) from the certifying agency. 9
(b) Laboratories certified by reciprocity shall pay the fees required by Rule .0806 of this Section. 10
(c) Any time that a laboratory has its certification with the reciprocal program discontinued for any reason, the State 11
Laboratory must be notified and Certificationcertification under this Section shall be terminated at the same time. 12
13
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 14
Eff. February 1, 1976; 15
Amended Eff. November 2, 1992; December 1, 1984. 16
17
Commented [DS227]: Added language to open up options to
laboratories by including other accreditation bodies such as The
NELAC Institute. Potentially has a negative impact on laboratories that could benefit from using another type of accreditation body for reciprocity and forego the expense of an initial on-site audit by our program.
Commented [SD228]: Grammatical correction - no effect
Commented [DS229]: No new requirement – no effect
Commented [DS230]: New requirement added for tracking purposes- No effect
40

15A NCAC 02H .0810 is proposed for readoption : 1
2
15A NCAC 02H .0810 ADMINISTRATION 3
(a) The Director of the Division of Water Quality, Department of Environment and Natural Resources or his their 4
delegate, is authorized to issue Certifications,certification, to reject applications for certification,Certification, to 5
renew certification,Certification, to issue recertification,Recertification to issue decertification,Decertification, and 6
to issue reciprocity certification.Certification. 7
(b) Appeals. In any case where the Director of the Division of Water Quality, Department of Environment and 8
Natural Resources or his delegate denies certification, or decertifies a laboratory, the laboratory may appeal to the 9
N.C. Office of Administrative Hearings in accordance with Chapter 150B of the General Statutes. 10
(c)(b) The State Laboratory will maintain a current list of certified commercial,Commercial, Municipal, Industrial, 11
Mobile, Field and Other Laboratories. laboratories. 12
(d) Implementation of the October 1, 2001changes to this Section. 13
(1) All requirements of the Rules in this Section are effective on the effective date of the amendments. 14
(2) Requests for the new parameters may be made by submitting a properly completed amendment 15
form. 16
(3) Laboratories subject to the amended requirements of these Rules must submit a completed 17
application, or amendment form, within three months of the effective date of the amendments. 18
Laboratories submitting an application or amendment form for any of the newly certifiable 19
parameters may analyze samples for these new parameters until the State Laboratory has issued or 20
denied certification. Fees for parameter additions requested during the initial three month period 21
will be calculated as initial certification fees. 22
(4) Laboratory facilities, not currently certified, that are performing analyses for Field Parameters 23
only must submit an application within three months of the effective date of the amendments. 24
After submitting an application, these laboratories may continue to analyze samples until the State 25
Laboratory has issued or denied certification. 26
27
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 150B-23; 28
Eff. February 1, 1976; 29
Amended Eff. November 2, 1992; July 1, 1988; December 1, 1984; November 1,1978; 30
Temporary Amendment Eff. October 1, 2001; 31
Amended Eff. August 1, 2002. 32
Commented [SD231]: Unnecessary - duplicative - no effect
Commented [DS232]: Added all types of laboratories – no new requirement - no effect - http://deq.nc.gov/about/divisions/water-resources/water-resources-data/water-sciences-home-page/laboratory-certification-branch/certified-laboratory-listings
Commented [DS233]: Removed because it pertained to Implementation of the original rule and is not necessary
Draft for Rule Revision (4/20/2017)
1
15A NCAC 02H .1100 is proposed for readoption: 1
2
15A NCAC 02H .1101 PURPOSE 3
These Rules set forth the requirements for certification of commercial, industrial, and public laboratories to perform 4
biological toxicity testing and aquatic population surveys of water and wastewater as required for National Pollutant 5
Discharge Elimination System (NPDES) permits by G.S. 143-215.3(a)(10) and Environmental Management 6
Commission Rules for Classifications and Water Quality Standards Applicable to the Surface Waters of North 7
Carolina, found in Subchapter 2B of this Chapter, Section .0200, and Rules for Surface Water Monitoring, Reporting, 8
found in Subchapter 2B of this Chapter, Section .0500. 9
10
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 143-215.66; 11
Eff. October 1, 1988; 12
Amended Eff. March 1, 1993. 13
14
Formatted: Font: Bold
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2
15A NCAC 02H .1102 is proposed for readoption: 1
2
15A NCAC 02H .1102 SCOPE 3
These Rules apply to commercial, industrial, or public laboratories which perform toxicity testing of water or 4
wastewater or conduct aquatic population surveys for persons subject to any requirements for monitoring of toxicity 5
through direct measurement of the effects of a specific water or wastewater oron aquatic organisms in laboratory tests 6
or through fieldaquatic population surveys. 7
8
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 143-215.66; 9
Eff. October 1, 1988. 10
11
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3
15A NCAC 02H .1103 is proposed for readoption: 1
2
15A NCAC 02H.1103 DEFINITIONS 3
The following terms as used in this Section shall have the assigned meaning: 4
(1) Aquatic population survey and analysis consists of field sampling, laboratory identification, analysis 5
and metric derivation for determination of biological integrity, as defined in 15A NCAC 02B 6
.0202(11) [if 02B is being changed, change this reference to the correct number], for fish, aquatic 7
macroinvertebrates, phytoplankton and aquatic macrophytes using methods developed per 15A 8
NCAC 02B .0103(b). Standard operating procedures used by the State are available for review on 9
the Division’s website. 10
(1)(2) Categories are groups of parameters which differ by measured test exposure regimes (chronic and 11
acute) and, in the case of toxicological assay, through the presence or absence of vertebrae in the 12
species of test organisms used or being a member of the plant kingdom. All fieldaquatic population 13
survey techniques are contained within one category. 14
(2)(3) Certification is a declaration by the Division that personnel, equipment, records, quality control 15
procedures, and methodology cited by the applicant are accurate and that the applicant’s applicants' 16
proficiency has been considered and found acceptable.to comply with these Rules. 17
(3)(4) Commercial Laboratory means any laboratory, including its employees and agents, which analyzes, 18
for others, wastewater samples for toxicity measurements or for their resultant impacts on the 19
receiving waters. 20
(4)(5) Decertification is the loss of certification. 21
(5)(6) Director means the Director of the North Carolina Division of Environmental Management, Water 22
Resources, or his successor. 23
(6)(7) Division means the North Carolina Division of Environmental Management, Water Resources, or 24
its successor. 25
(7)(8) Evaluation samples are known samples submitted by the State Laboratory to the commercial, 26
industrial, or public laboratory as an unknown toxicant for measurement of toxicity or as an 27
unknown set of preserved organisms for identification to specified levels of taxonomic 28
classification. 29
(8)(9) Falsified data or information means data or information that that, whether by intent, negligence, or 30
reckless disregard for accuracy has been made untrue by alteration, fabrication, intentional omission, 31
substitution, or mischaracterization.altered, fabricated, or otherwise reported and/or recorded falsely 32
or mischaracterized by omission or substitution, such that the value or information reported is 33
incorrect, incomplete, and/or inaccurate. The agency need not prove intent to defraud to prove data 34
is falsified. 35
(9)(10) Inaccurate data or other information means data or information that is in any way incorrect or 36
mistaken. 37
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(10)(11) Industrial Laboratory means a laboratory, including its employees and agents, operated by an 1
industry to analyze samples from its wastewater treatment plants for toxicity measurements or 2
resultant impacts to receiving waters.waters or to conduct aquatic population surveys. 3
(11)(12) Parameters are subgroups of categories. Parameters are unique and separate if they are in separate 4
categories or are performed using different species of test organisms. For the category, Aquatic 5
Population Survey, separate parameters are to be considered fish, aquatic macroinvertebrates, algae, 6
phytoplankton, and aquatic macrophytes, and zooplankton.macrophytes. 7
(12)(13) Public Laboratory means a laboratory, including its employees and agents, operated by a 8
municipality, county, water and sewer authority, sanitary district, metropolitan sewerage district, or 9
state or federal installation or any other governmental unit installation, or any other governmental 10
unit, to analyze samples from its wastewater treatment plant(s) for toxicity measurements or 11
resultant impacts to receiving waters. waters or to conduct aquatic population surveys. 12
(13)(14) Recertification is reaffirmation of certification. 13
(14)(15) Split samples are samples from either a surface water effluent discharge, surface water, or aquatic 14
biological population survey which are segregated at the point of sampling or in the case of field 15
survey collected independently and then analyzed separately by both the State Laboratory and the 16
commercial, public or industrial laboratory.sample for surface water effluent discharge, surface 17
water, or phytoplankton means two or more representative portions taken from a single sampling 18
device. For aquatic macrophytes or macroinvertebrates, the same sample is analyzed by the State 19
Laboratory and the commercial, industrial, or public laboratory. 20
(16) (15) State laboratory means the Environmental Sciences Branch of the Water Quality Section of the 21
North Carolina Division of Environmental Management Water Sciences Section of the North 22
Carolina Division of Water Resources or its successor. 23
(17)(16) Toxicant – Any means any specific chemical or compound or mixture of chemicals or compounds 24
regulated within an NPDES permit and/or defined as a toxic substance in Rule .0202 of Subchapter 25
2B. 26
27
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 143-215.66; 28
Eff. October 1, 1988; 29
Amended Eff. April 1, 1993. 30
31
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5
15A NCAC 02H .1104 is proposed for readoption: 1
2
15A NCAC 02H .1104 FEES ASSOCIATED WITH CERTIFICATION PROGRAM 3
(a) Certification Fees: 4
(1) Certification Fees shall be a minimum of five hundred dollars per year ($500.00). The first category 5
will be certified at a cost of five hundred dollars ($500.00). Additional categories will be certified 6
at a cost of four hundred dollars ($400.00) per category. The addition of parameters not included in 7
the original certification will be certified at a cost of one hundred dollars ($100.00) per parameter. 8
(2) Certification fees are due upon application and no later than 45 days prior to the requested 9
certification date. 10
(b) Renewal Fees: 11
(1) The certified laboratory will pay the state a four hundred dollar ($400.00) per year renewal fee for 12
each category of certification or the minimum fee of five hundred dollars ($500.00) if only one 13
category is certified. Renewal certification fees are due by November 1 annually. 14
(2) Recertification fees shall be four hundred dollars ($400.00) per category recertified. 15
(3) Out-of-state laboratories shall reimburse the state for actual travel and subsistence costs incurred in 16
certification, recertificationrecertification, and maintenance of certification. 17
18
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 143-215.66; 19
Eff. October 1, 1988. 20
21
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6
15A NCAC 02H .1105 is proposed for readoption: 1
2
15A NCAC 02H .1105 CERTIFICATION 3
(a) Certification is affirmation by the Director or his their delegate that the requirements specified by these rules have 4
been met for specific categories and parameters and that all fees associated with certification have been received. 5
(b) Commercial, public and industrial, and public laboratories must obtain certification from the Division of 6
Environmental Management Water Resources only for biological parameters which will be reported to comply with 7
the rules and requirements as stated in an administrative letter, permit condition, permit limit, special order by consent, 8
judicial order, or the biological monitoring requirements established by the Division. 9
(c) For the purposes of certification and setting fees, parameters are grouped in the following five 10
categories: 11
(1) Acute Toxicity Testing/Invertebrate; 12
(2) Acute Toxicity Testing/Vertebrate; 13
(3) Chronic Toxicity Testing/Invertebrate; 14
(4) Chronic Toxicity Testing/Vertebrate; 15
(5) Agal Algal and Aquatic Plant Toxicity Testing; 16
(6) Aquatic Population Survey and Analysis. 17
(d) All certifications are designated for the period of one year after initial certification. 18
(e) Protocol Documents considered as standard methodology and facilities and equipment requirements considered as 19
minimum acceptable resources will be listed in the Certification Criteria/Procedures Document. are listed in the 20
certification application available on the Division’s website. 21
22
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(1)(10); 143-215.66; 23
Eff. October 1, 1988. 24
25
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15A NCAC 02H .1106 is proposed for readoption: 1
2
15A NCAC 02H .1106 DECERTIFICATION 3
(a) A laboratory certification may be revoked for all categories for: 4
(1) Failing to maintain the facilities, records, personnel, equipment or quality assurance program as set 5
forth in the application or these Rules; or 6
(2) Submitting inaccurate or falsified data reports or other information; or 7
(3) Failing to pay required fees by the date due. 8
(b) A laboratory certification may be revoked for a category for failure to: 9
(1) Obtain acceptable results on two consecutive evaluation sample submittals from the Division. 10
Acceptable results on performance evaluation samples are those that vary by less than two standard 11
deviations of the value established by the Division. The state laboratory State Laboratory may apply 12
specific variance or statistical limits or performance criteria on performance evaluation samples or 13
split samples for a particular testing procedure, including control population effects and taxonomic 14
identification, as published in the Certification Criteria/Procedures Document; or 15
Certification/Criteria Procedures Document available on the Division’s website; 16
(2) Obtain acceptable results as set out in Paragraph (1) of this Rule on two consecutive split samples 17
that have also been analyzed by the Division; or 18
(3) Submit a split sample to the Division as requested; or 19
(4) Use approved testing techniques; or 20
(5) Report to the state laboratory equipment changes that would affect its the laboratory’s ability to 21
perform a test category to the State Laboratory within 30 days of such change; or 22
(6) Report to the state laboratory analysis of performance evaluation samples submitted by the Division 23
to the State Laboratory within required time of completion; or 24
(7) Maintain records and perform quality controls as set forth by these Rules and the Division for a 25
particular category; or Certification/Criteria Procedures Document available on the Division’s 26
website; 27
(8) Maintain equipment required for any certified parameter; or 28
(9) Implement and maintain Quality Control Programs approved in conjunction with certification; or 29
(10) Maintain a qualified staff. 30
(c) Decertification Requirements: 31
(1) A laboratory is not to analyze samples for parameters in decertified categories for programs 32
described in Rule .1102 of this Section. 33
(2) A decertified commercial laboratory must notify any clients affected by the decertification of such 34
and supply the state laboratory State Laboratory with a list of those clients affected and written 35
certification that those clients have been notified. Should the decertified laboratory arrange for a 36
certified laboratory to perform analyses during the period of decertification, the decertified 37
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8
laboratory must supply the Division with the name of the replacement laboratory and the client(s) 1
involved. The certified laboratory's name which performs analyses must appear on all data submitted 2
to the Division. 3
4
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 143-215.66; 5
Eff. October 1, 1988; 6
Amended Eff. March 1, 1993. 7
8
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9
15A NCAC 02H .1107 is proposed for readoption: 1
2
15A NCAC 02H .1107 RECERTIFICATION 3
(a) A laboratory decertified for any reason, other than the submittal of falsified data reports or other information, may 4
be recertified after 30 days, upon satisfactory demonstration to the state laboratory State Laboratory that all 5
deficiencies have been corrected. 6
(b) In the case of a laboratory decertified for submitting falsified data reports or other information, recertification 7
shall not occur until at least 12 months after the decertification and then only at such time as the laboratory has 8
satisfactorily demonstrated to the Director or their delegate that the standards for initial certification have been met. 9
(c) Should decertification occur due to either failure of performance samples or split samples, a written request must 10
be made to the state laboratory State Laboratory requesting evaluations similar to the parameters for which the 11
laboratory was decertified. Two consecutive samples must be successfully evaluated to achieve recertification. The 12
first of these samples for recertification will be submitted or arranged by the Division no later than 30 days after receipt 13
of the written request. The second will be submitted or arranged no later than 30 days after the first. 14
15
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 143-215.66; 16
Eff. October 1, 1988; 17
Amended Eff. March 1, 1993. 18
19
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10
15A NCAC 02H .1108 is proposed for readoption: 1
2
15A NCAC 02H .1108 RECIPROCITY 3
(a) Laboratories certified by other states or federal programs may be given reciprocal certification where such 4
programs meet the requirements of these Rules. In requesting certification through reciprocity, laboratories shall 5
include with the application a copy of their certification and the rules of the original certifying agency. 6
(b) Laboratories certified on the basis of program equivalency shall pay all fees specified by these Rules. 7
8
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 143-215.66; 9
Eff. October 1, 1988; 10
Amended Eff. March 1, 1993. 11
12
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11
15A NCAC 02H .1109 is proposed for readoption: 1
2
15A NCAC 02H .1109 ADMINISTRATION 3
(a) The Director of the Division of Environmental Management ,Water Resources, Department of Environment, 4
Health, and Natural Resources, Environmental Quality, or his their delegate, is delegated authority to issue 5
certification, to reject applications for certification, to renew certification, to issue recertification, to issue 6
decertification, and to issue reciprocity certification. 7
(b) Appeals. In any case where the Director or their delegate denies certification, or decertifies a laboratory, the 8
laboratory may appeal to the N.C. Office of Administrative Hearings in accordance with Chapter 150B of the General 9
Statutes. 10
(c) The State Laboratory will maintain a current list of certified commercial, industrial, or public laboratories 11
laboratory. 12
13
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 143-215.66; 14
Eff. October 1, 1988; 15
Amended Eff. March 1, 1993. 16
17
18
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15A NCAC 02H .1110 is proposed for readoption: 1
2
15A NCAC 02H .1110 IMPLEMENTATION 3
(a) Each laboratory requesting state certification or certification renewal or recertification shall submit an application 4
in duplicate to the Division. Each application will be reviewed to determine the adequacy of personnel, equipment, 5
records, quality control procedures and methodology. After receiving a completed application and prior to issuing 6
certification, a representative of the Division may visit each laboratory to verify the information in the application and 7
the adequacy of the laboratory. 8
(b) Analytical methods, sample preservation, sample containers and sample holding times shall conform to the 9
methodologies specified in the Certification/ Criteria Procedures Document.Document available on the Division’s 10
webpage. Deviations from these methods are acceptable only upon prior written approval from the state laboratory 11
State Laboratory. 12
(c) In order to maintain certification, each laboratory will demonstrate satisfactory performance on evaluation samples 13
submitted byto the Division. These will be required no more than three times annually of certified laboratories for 14
each parameter certified. 15
(d) In order to receive and maintain certification, the following minimum criteria must be met: 16
(1) The supervisor of an aquatic toxicology or biological survey laboratory must have a minimum of a 17
B.S.4 year degree from an accredited college or university in a biological science or closely related 18
science curriculum and at least three years of cumulative laboratory experience in aquatic toxicity 19
testing or aquatic biological survey, population surveying, as appropriate, or a M.S. degree in a 20
biological or closely related science and at least one year of cumulative laboratory experience in 21
aquatic toxicity testing or aquatic biological survey, aquatic population surveying, as appropriate. 22
(2) All laboratory supervisors are subject to review by the Division. One person may serve as supervisor 23
of no more than two laboratories. The supervisor is to provide direct supervision and evaluation of 24
all technical personnel and is responsible for the proper performance and reporting of all analyses. 25
Upon absence, the supervisor shall arrange for a suitable substitute (as defined in (d)(1), above) 26
capable of insuring the proper performance of all laboratory procedures. Existing laboratory 27
supervisors who do not meet the minimum requirements may be accepted after review by the 28
Division if they meet all other certification requirements and previous performance is deemed 29
adequate. 30
(3) All applications and fees are due 45 days prior to the requested certification date.pursuant to Rule 31
.1104 of this Section. Problems identified with the applying laboratory and resolution of these 32
problems may extend the requested 45 day period from application to certification. 33
(4) Each laboratory shall develop and maintain a document outlining quality control procedures for all 34
parameters in their certification and dissolved oxygen, temperature, and pH. All aquatic toxicology 35
laboratories must also develop and maintain a document outlining quality control procedures for 36
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13
total hardness and total residual chlorine. These documents are to be included with submittal of the 1
application. 2
(5) Each laboratory certified for the category of Aquatic Population Survey and Analysis shall develop 3
and maintain a document outlining quality control procedures for taxonomic identifications and life 4
stagelifestage determinations. 5
(6) Supporting records shall be maintained for a minimum of five years as evidence that these practices 6
are being effectively carried out and shall be available to the state laboratory State Laboratory upon 7
request. 8
(7) The quality control program is to be approved in conjunction with certification by the 9
Director.Director or their delegate. 10
11
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 143-215.66; 12
Eff. October 1, 1988; 13
Amended Eff. October 1, 1993 14
15
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15A NCAC 02H .1111 is proposed for readoption: 1
2
15A NCAC 02H .1111 BIOLOGICAL LABORATORY CERT/CRITERIA PROCEDURES DOCUMENT 3
The Biological Laboratory Certification/Criteria Procedures Document describes specific scientific reporting 4
units, forms, test methods and procedures pertaining to certification. 5
The manual, and any addition thereto, shall be approved by the director before it is released to the public. The 6
manual shall be mailed to all certified biological laboratories and to any persons on the mailing list. To be placed on 7
the mailing list, a letter must be sent to the director. 8
If the manual is revised at any time, all changes shall be sent to the certified biological laboratories and those 9
persons on the mailing list will be notified. 10
(a) The Biological Laboratory Certification/Criteria Procedures Document (also referred to as the 11
Certification/Criteria Procedures Document or the document) describes specific scientific reporting units, forms, test 12
methods and procedures pertaining to certification. This document is available on the Division’s website. 13
(b) The document, and any addition thereto, shall be approved by the Director or their delegate before it is released 14
to the public. The document shall be made available online to all certified biological laboratories and to any persons 15
on the mailing list. To be placed on the mailing list, a letter or electronic request must be sent to the Director or their 16
delegate. 17
(c) If the document is revised at any time, the certified biological laboratories and those persons on the mailing list 18
will be notified. 19
20
History Note: Authority G.S. 143-215.3(a)(1); 143-215.3(a)(10); 143-215.66; 21
Eff. October 1, 1988. 22
23
24
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