&EPA
     United States
     Environmental Protection
     Agency
Labcert   Bulletin
     Editor's Notes...

          This issue of the Labcert Bulletin highlights
          NELAC with articles written by Silky
          Labie, the current Chair of the NELAP
     Board of Directors, and the Chairs of the On -Site
     Assessment Committee and the Quality Systems
     Committee. Contents of these articles are entirely
     the authors', printed here as information. Articles
     about some of the other Committees were featured
     in the March, 2001 Labcert Bulletin.

     There is also information on new contaminants for
     which certification is required, new PT acceptance
     criteria for  THMs, other Proficiency  Testing
     requirements, and a list of helpful web sites.

     As always, we want to hear from you. If there are
     certification  topics you would  like  to see
     discussed, please call, write, fax or e-rnail the
     editors. There is a form on the last page for you to
     use to add your name to our mailing  list or to
     update your information.

     EdGlick 513 569-7939, glick.ed@epa.gov

     Patricia Hurr 513 569-7678, hurr.pat@epa.gov

     Caroline Madding 513569-7402,
     madding.caroline@epa.gov

     MAILING ADDRESS:
           USEPA  MS 140
           Technical Support Center
           26 W. Martin Luther King Dr.
           Cincinnati, OH 45268

     FAX NUMBER:
            513 569-7191
             Confusion Regarding the

                      "80% Rule"

                  We have received numerous questions
                  regarding the "80% Rule" for passing
                  PT samples. This Rule applies to two
          classes of analytes, volatile organic compounds
          (VOCs) and the five regulated haloacetic acids
          (HAAS).

          Realizing that successfully  analyzing a PT
          sample containing all VOC analytes annually is
          difficult, EPA allows the laboratory leeway in the
          analysis  of the VOC PT samples. Excluding
          vinyl chloride, if the laboratory passes 80% of
          the VOC analytes, it can be certified for all of the
          VOCs.  The "80% Rule" for VOCs has recently
          been made more difficult to interpret since some
          PT providers may include THMs in the same vial
          as the VOCs.  The "80% Rule" does not apply to
          the THMs if they are present in the VOC ampule.
          THMs must be acceptably analyzed individually
          (see DBF Rule  article on p.5) in order to be
          certified to perform TTHM analyses.

          In  the Stage 1  DBF  rule, which becomes
          effective  in  January 2002,  the "80%  Rule"
          applies to the HAAS certification requirement.
          If four  of the  five haloacetic acids which
          comprise  HAAS  (80%)   are  successfully
          analyzed, the laboratory may be certified to
          perform HAAS analyses.
                          a rederal requirement to
                        \JStfr*#a»n*  J»S   ,sfL   _•*«», «=%»,*>
                        e tunregufated VOCs or to
                        '^vMBi^^*V8t»4w
-------
&EPA
    United States
    Environmental Protection
    Agency
   Office of Ground Water and Drinking Water
   Cincinnati, OH 45268
   EPA-815-N-02-001a
   January 2002
PRESORTED STANDARD
 POSTAGE & FEES PAID
         EPA
   PERMIT NO. G-35
   Official business
   Penalty for Private Use
   $300
                          In This Issue...

                          / NELAC 7 Highlights
                          S More Contaminants Require
                             Certification
                          S New PT Acceptance Criteria for
                             THMs
                          «/ More on Proficiency Testing
                             Requirements
                          S Some Useful Websites
                             Recycled/Recyclable
                             Printed with vegetable-based ink on paper that
                             contains a minimum of 50% post-consumer fiber
                             and is processed chlorine free.

-------
&EPA
     United States
     Environmental Protection
     Agency
Labcert   Bulletin
     Editor's Notes...

          This issue of the Labcert Bulletin highlights
          NELAC with articles written by Silky
          Labie, the current Chair of the NELAP
     Board of Directors, and the Chairs of the On -Site
     Assessment Committee and the Quality Systems
     Committee. Contents of these articles are entirely
     the authors', printed here as information. Articles
     about some of the other Committees were featured
     in the March, 2001 Labcert Bulletin.

     There is also information on new contaminants for
     which certification is required, new PT acceptance
     criteria for THMs, other  Proficiency Testing
     requirements, and a list of helpful web sites.

     As always, we want to hear from you.  If there are
     certification topics  you would  like to see
     discussed, please call, write, fax or e-rnail the
     editors. There is a form on the last page for you to
     use to add your name to our mailing  list or to
     update your information.

     Ed Click 513 569-7939, glick.ed@epa.gov

     Patricia Hurr 513 569-7678, hurr.pat@epa.gov

     Caroline Madding 513569-7402,
     madding.caroline@epa.gov

     MAILING ADDRESS:
          USEPA MS 140
          Technical Support Center
          26 W. Martin Luther King Dr.
          Cincinnati, QH 45268

     FAX  NUMBER:
           513 569-7191
             Confusion Regarding the

                     "80% Rule"

                 We have received numerous questions
                 regarding the "80% Rule" for passing
                 PT samples. This Rule applies to two
          classes of analytes, volatile organic compounds
          (VOCs) and the five regulated haloacetic acids
          (HAAS).

          Realizing that  successfully  analyzing a PT
          sample containing all VOC analytes annually is
          difficult, EPA allows the laboratory leeway in the
          analysis of the VOC PT samples. Excluding
          vinyl chloride, if the laboratory passes 80% of
          the VOC analytes, it can be certified for all of the
          VOCs. The "80% Rule" for VOCs has recently
          been made more difficult to interpret since some
          PT providers may include THMs in the same vial
          as the VOCs.  The "80% Rule" does not apply to
          the THMs if they are present in the VOC ampule.
          THMs must be acceptably analyzed individually
          (see DBP Rule article on p.5) in order to be
          certified to perform TTHM analyses.

          In the Stage  1  DBP rule, which becomes
          effective in January  2002,  the "80% Rule"
          applies to the HAAS certification requirement.
          If four of the five  haloacetic acids which
          comprise  HAAS  (80%)  are  successfully
          analyzed,  the laboratory may be certified to
          perform HAAS analyses.
                                      irement to
                                     * *,  tf - iv **
                                    VOCs or to
                                    ~grf yt** ** »*• •* -*tf*^¥ «-*•
                                   analytes. This
                                   "    .- — ~
                                       e'
                                       ^

-------
T
           Highlights from NELAC  7
                           by Silky S. Labie, Chair
                         NELAC Board of Directors

he weather was mild and sunny, and Salt Lake City was beginning to roll out the Red Carpet for the
Winter Olympics. NELAC 7, hosted by the Utah Department of Health, could not have had a better
setting.
The revisions to the NELAC standards can be roughly categorized as: fixes, clarifications, and major
direction changes.
FIXES: These revisions were designed to "fix"
something in the standard, whether it was to close
loop holes, or help resolve inconsistencies of the
NELAP implementation process: The revisions
1. Provide specific circumstances under which a
   technical director  can be grandfathered in.
   (Chapter 4).
2. Outline the  manner in which  differing
   standard interpretations  will  be  resolved.
   (Chapter 6).
3. Provide comprehensive requirements  for the
   content of general and  technical assessor
   training courses (Chapter  3).
4. Require that  the NELAP assessment team
   observe  the  techniques  used  by  the
   Accrediting Authority during an on-site audit.
   (Chapter 6).

CLARIFICATIONS: These revisions were made to
clarify or simplify existing standards, with no
significant changes:
1. Refined  and  simplified   Appendix D.I.,
   Chemical  Quality Controls and Appendix
   D.3.,   Microbiological   Quality  Controls
   (Chapter 5).

MAJORCHANGES IN DIRECTION: These revisions
will have a significant impact on how NELAP is
implemented:
1. Fields of Accreditation were changed from
Program-Method-Analyte to Matrix-Technology
                                             Method-Analyte/Analyte Group (Chapter 1).
                                          2.  The Fields of Proficiency Testing were also
                                             changed to reflect to changes in Chapter 1:
                                             matrix-technology-analyte/analyte  group
                                             (Chapter 2).

                                          Conferees came to NELAC 7 with questions about
                                          EPA's continuing support.   They left with the
                                          knowledge that  EPA has negotiated a 5-year
                                          contract at the present level of funding to support
                                          NELAC, and that EPA has applied for recognition
                                          as a NELAP Accrediting Authority.

                                          Further, the conferees found that NELAC was
                                          responsive to the criticisms and anxieties about
                                          inconsistencies  among  NELAP  Accrediting
                                          Authorities  by   developing  standards,  and
                                          implementing many proactive programs designed
                                          to minimize their concerns.

                                          A majority of the standard revisions were minor
                                          corrections that did not alter the intent of the
                                          standard. NELAC can finally settle down to focus
                                          on implementation and encouraging more states to
                                          join the NELAC community.

                                          More information on NELAC may be found at the
                                          NELAC website: "http://www.epa.gov/ttn/nelac/".

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                   NELAC Quality Systems
                                    by Scott D. Siders
                              Illinois EPA, Springfield, IL
                    Past Chair, NELAC Quality Systems Committee

      The National Environmental Laboratory Accreditation Conference (NELAC) at its annual meeting
      (NELAC 7) which was held May 22 - 25, 2001 in Salt Lake City, Utah, adopted proposed changes
      to the Quality Systems standard. At the Interim Meeting (NELAC 6i) in November 2000 the NELAC
 7 Quality Systems Committee:
 •   discussed the  efforts to update the Quality
    System  standard to the new- international
    standard (ISO/IEC 17025);
 •   reviewed  the   Environmental  Laboratory
    Advisory Board's (ELAB) proposed changes to
    the Chemical Testing section;
 •   presented   proposed   changes  for  the
    Microbiology Testing section; and
 •   reviewed its efforts to draft an Asbestos Testing
    Appendix.

 A significant new direction was taken based on
 ELAB's  presentation  of a Performance-Based
 Measurement System (PBMS) straw model.  The
 Committee,  at the urging of other  NELAC
 stakeholders, formed a PBMS  Subcommittee to
 review  the  PBMS straw  model  and further
 investigate incorporating PBMS into NELAC.

 At NELAC 7, there was overwhelming support for
 the Quality Systems standard to be consistent with
 ISO/IEC 17025 in both content and format. Some
 significant additions and/or changes to the standard
 would be sections on:
 1.  Identification of potential conflicts of interest
 2.  Service to clients
 3.  Preventive action
 4.  Corrective action
 5.  Method validation
 6.  Measurement uncertainty
 7.  Document control
 8.  Requests, tenders and contracts

 Further, the  proposed  revisions to the  Quality
 Systems standard will include the sections that the
PBMS Subcommittee is modifying. ELAB's PBMS
 straw model brought two key concepts to the table:
 •   Method selection; and
 •   Method validation.

 To  address  the   PBMS  straw  model
 concepts/elements the  following sections of the
 model are important areas to revise:
 •   Test   methods  and  standard   operating
    procedures;
 •   Calibration;
 •   Demonstration of capability; and
 •   Chemical testing.

 As a result, the PBMS Subcommittee has essentially
 completely  rewritten  sections of the  Quality
 Systems standard, which will be discussed at the
 next Interim Meeting in December. The Quality
 Systems  Committee is currently reviewing and
 commenting on the PBMS Subcommittee's most
 recent proposal.  This proposal has, at its core,
 language for method  selection  and  validation
 including:
 •   a proposed model for initial method validation
    based upon representative matrices;
 •   ongoing method validation steps to determine
    and document sources of uncertainty relating to
    actual samples and system influences.

 The PBMS Subcommittee is currently, among other
 things, considering whether a "tiered" approach to
 method  validation  should  be  considered,
 differentiating between EP A-mandated methods and
 alternative methods.

 Again,   at  NELAC  7  the  Quality  Systems
 Committee's ISO/IEC 17025 integration effort and
the PBMS Subcommittee's efforts were presented
publicly for the first time during a special session,

-------
as these two issues were not put to a vote. A straw
poll revealed broad support for the full integration
of ISO/IEC17025 by allNELAC stakeholders (i.e.,
states, federal agencies, and the private sector).

The Quality Systems Committee included on the
NELAC voting agenda changes to microbiology
testing and ELAB's recommendations on chemical
                                          testing. These proposed changes were adopted with
                                          minor modifications (e.g., Method Blank Criteria).
                                          The final 2001 standards are posted on the NELAC
                                          Homepage    website    at:
                                          http ://www.epa. gov/ttnnelal /.
   NELAC On-site Assessment  Committee
C
                           by Alfredo Sotomayor
                   On-site Assessment Committee Chair

ertification and inspections, accreditation and on-site assessments, in NELAC parlance, are linked
inextricably. It has been said that an accreditation program is only as good as the laboratory assessments
it delivers. The On-site Assessment Committee is responsible for generating procedures that Accrediting
Authorities  (AA)  use  to  perform  on-site
assessments.  Through Chapter 3, the committee
specifies  such  essentials  as  the  frequency,
mechanics, and documentation of assessments, and
establishes qualifications for laboratory assessors.
The  On-site  Assessment  Committee is also
responsible for generating and maintaining the
NELAC Quality Systems (Chapter 5) Checklist.

At the last NELAC Annual Meeting (May 2001),
the   conference  approved for  immediate
implementation two appendices in Chapter 3 that
identify  the  content  of  training courses for
laboratory assessors.  Appendix  A specifies the
minimum standards for NELAC Basic Assessor
Training Courses, while Appendix B does the same
for Technical Training Courses. NELAC and the
National Environmental Laboratory Accreditation
Program (NELAP) themselves cannot offer training
courses, but now that the appendices are approved,
providers should start designing and  marketing
courses that can be used to meet NELAC training
requirements for assessors.

The On-site Assessment  Committee is currently
                                           drafting another appendix that specifies elements
                                           that all AAs will need to address in a Standard
                                           Operating  Procedure   (SOP)   for planning,
                                           conducting, and closing laboratory assessments. We
                                           will present a second draft of this appendix for
                                           discussion at the next interim meeting in December.
                                           We envision that this appendix will give more
                                           specificity to the activities assessors use  and the
                                           type and number of records examined to assess a
                                           laboratory's conformance to the NELAC Standards.

                                           EPA has acknowledged that a state can meet the
                                           primacy requirements of the Safe Drinking Water
                                           Act (SOWA)  regulations by obtaining NELAP
                                           recognition in the NELAC SDWA tier.  As EPA
                                           makes progress in becoming an AA, the Committee
                                           will explore ways of formalizing the equivalency
                                           between SDWA laboratory certification audits and
                                           NELAC laboratory  on-site  assessments.   The
                                           Committee welcomes your comments on Chapter 3,
                                           or  any issues  related to  laboratory   on-site
                                           assessments.  Use the form posted on the NELAC
                                           website   and  send   it   electronically  to
                                           sotoma@.dnr.state.wi.us

-------
New Contact  for

USEPA Laboratory  ID

Numbers

     Effective April 1, 2001, Charles Feldmann,
     Office of Ground Water and Drinking Water,
     Technical Support Center,  is the primary
contact for assignment of new laboratory IDs for the
PT studies. He may be reached by phone at 513-
569-7671 or by FAX at 513-569-7191.

1) If the laboratory has ever participated in an
USEPA-run study, the laboratory will already have
a unique ID.  Please review any previous "study
results" report to locate the ID number.

2) If a laboratory cannot locate this information, the
laboratory should contact  Mr.  Feldmann for
assistance.

3) Laboratories must include this information when
reporting PT results.


Certification  Changes

      On December 1, 1999 EPA published a final
      rule often referred  to  as MUFRN  II
      (Methods Update Federal Register Notice
II)  in the Federal Register (64 FR 67450).  In
addition to approving several updated or new
drinking  water   methods   for  chemical and
microbiological contaminants, the Rule amended
some laboratory certification requirements.

Specifically, the Rule amended the regulations to
codify some of the provisions in the 1997 Drinking
Water Laboratory Certification Manual.   These
amendments include a requirement to demonstrate
proficiency by successful analysis of a PT sample
annually for chemical contaminants using the same
analytical method that is used to report compliance
monitoring results. In order to receive and maintain
certification for an analyte, the laboratory must
successfully analyze  PT samples (if available)
acceptable to the EPA or the State at least once per
year for each analyte and by each method used to
analyze compliance samples. This does not include
methods used solely for corifirmation.

Because of this requirement, we are requesting that
Certifying Authorities list on  the  certification
certificate or a letter attached to the certification
certificate, the methods and each analyte in that
method for which the laboratory is certified.


Certification Alert

Stage  1  DBF Rule

Effective January 2002

     The Stage  1 Disinfection By-Product (DBF)
     Rule,  which was promulgated in December
     1998, became  effective for large  surface
water systems in January 2002 and all laboratories
should be certified by this date to analyze HAAS,
chlorite and bromate.

The Rule lowers the  MCL for TTHMs to 0.080
mg/L and sets the MCL for HAAS at 0.060 mg/L.
Haloacetic acid 5 is the sum of the concentrations of
five haloacetic  acids  (HAAS): monochloroacetic
acid, dichloroacetic  acid,  trichloroacetic  acid,
monobromoacetic acid and dibromoacetic acid. It
also sets MCLs of 0.010 mg/L for bromate and 1.0
mg/L for chlorite.

The Rule requires that laboratories be certified to
perform these analyses for compliance monitoring.
To be certified, the laboratory must annually pass
PT  samples for these analytes. The  "80% Rule"
applies to the HAAS, so if four of the HAA5 are
successfully  analyzed,  the  laboratory  may  be
certified for all of the HAAS. A laboratory should
not be certified for an analyte if it  fails 3
consecutive PT studies.

Trihalomethane PT acceptance criteria also changed
when the DBF  Rule became effective in January
2002. In the past, a laboratory reported the total
THM concentration in the PT sample, and passed
the PT if the value reported was within ±80% of the
true value.   Under the DBF Rule, each THM

-------
concentration must be reported, evaluated  and
passed individually to pass the PT sample.  The
DBF Rule also states that if a laboratory fails one
THM, it cannot be certified for TTHMs, but must
analyze another PT sample and pass all four of the
THMs to be  certified to analyze  compliance
monitoring samples for  total  trihalomethanes.
Laboratories must use EPA Methods 502.2, 524.2,
or 551.1 to analyze for THMs.  Methods required
for analysis of HAAs are EPA 552.1 or 552.2 or
SM 6251B (552.2 is recommended over 552.1).
Laboratories must use EPA Methods 300.0 or 300.1
to determine  chlorite  and  Method  300.1 to
determine bromate.

The DBP Rule also requires that water systems
monitor for TOCs.  The regulation requires the TOC
analyses be performed by a party approved by the
State. This is the same language that has been used
in the past for other non-MCL requirements such as
pH, turbidity,  alkalinity, etc. Standard Methods
531 OB, C or D must be used.


PT Data  Reporting

Guidance

   In order for the providers to process the studies
   properly and more efficiently, please follow the
guidelines below when reporting your PT results.

Always fill  out form  correctly and completely.
Include the laboratory name, address, contact person
and   the  unique  EPA   laboratory   ID code.
Procedures for finding  and/or getting a unique
laboratory code are explained on page 5.

If the laboratory is analyzing a subset  of the
contaminants in a PT sample, only enter data in the
report field  when  that  contaminant  is being
analyzed. That is, if you do not want to report or be
evaluated for a contaminant, leave that data  field
blank.

If you want to be assessed for a contaminant but
determine that it is not present, use a < value with
your  minimum reporting level (MRL) or  your
method  detection limit (MDL) whichever the
laboratory prefers.  The NELAC PT committee is
developing a list of PT reporting limits, which a
laboratory may use and be confident that the value
is lower than the acceptable range for PT samples.
Never report a zero or an alpha character in the data
field.


Micro Proficiency

Testing Studies:

What is Considered

Proper Analysis?

    Each microbiology performance  test  (PT)
    consists of ten samples to be analyzed as a
single PT sample set.  These are shipped in either
lyophilized, dehydrated, or aqueous condition. Each
PT sample set should be analyzed using one method
only, i.e., by either the Membrane- Filtration (MF),
Presence-Absence  (P-A), or  a  Chromogenic/
Fluorogenic method. Each of the ten samples must
be  analyzed and  reported  for the presence  or
absence of total coliform bacteria, and then for the
presence  or absence  of fecal  coliform/E. coli
bacteria.   Each set is randomly composed  of
samples that  are:  l)total coliform absent, fecal
coliform/E. coli absent, 2) total coliform present,
fecal coliform/E.  coli absent, 3)  total  coliform
present, fecal  coliform/E. coli  present,  and  4)
blanks.

Acceptable performance for the analysis of total
coliform bacteria requires the correct analysis of a
minimum of 9 out of the 10 samples, with no false
negative reported values.  Acceptable performance
for the analysis of fecal coliform/E. coli bacteria
requires the correct analysis of a minimum of 9 out
of the  10 samples, with no false negative reported
values. In other words, one false positive may be
reported for each analyte.  The PT provider will
issue a report indicating the acceptable performance
for the analysis of total coliform bacteria and the
acceptable performance for the analysis of fecal
coliform/.^1. coli bacteria, utilizing one technology.
The PT sample set may not be split, in any manner,
to run more than one technology.

-------
Radiological   PT

Samples Now Available

"|3 adiological performance testing samples are
.lAjtiow available from a NIST approved provider.
All laboratories wishing to maintain certification for
these parameters should successfully analyze one set
per year. If the alpha emitters and a mixed group of
the other regulated contaminants are analyzed, that
should suffice as a complete set.
Websites
        Fax It To Us

Please add/change (circle one) my name to the
Labcert Bulletin mailing list.
   Name:	
   Company:.
   Address:
   Telephone:.
   Fax#:
Fax to:       Susan Hagedorn
             USEPA - TSG
             26 W. M.L. King Drive
             Cincinnati, OH 45268
             513-569-7191
    An electronic version of this publication
    and more can be found on the Office of
Ground Water and Drinking Water website:
http ://www.epa. gov/safewater/standards.html.
This site also has information about drinking
water regulations and laboratory certification.
The "Manual for the Certification of Laboratories
Analyzing Drinking Water," the errata sheets for
this manual, and past issues of the Labcert
Bulletin can all be found at this address.

Other websites that you may find useful are:

www.epa.gov/safewater/faq/sco.htm This site
has been very useful to the editors. It lists
certification contacts for every state and also gives
links to some of the states' lists of laboratories
certified for drinking water analyses.  There are
links for about half of the states, the ones that
have electronic lists of their certified laboratories.

www.epa. gov/ttn/nelac/ This site contains the
NELAC Standards, lists NELAC Accrediting
Authorities and accredited laboratories, and has
information about past and future NELAC
meetings.

www.ts.nist.gov/ts/htdocs/210/214/scopes/progra
ms.html lists NIST accredited PT providers.

www.epa.gov/ogwdw/regs.html You can find the
drinking water regulations at this site.

www.epa.gov/ogwdw/methods/methods.html.
lists all promulgated methods and contains copies
of some methods.

www.epa. gov/quality/ The is the EPA Quality
Staffs home page and all EPA Quality
Documents and requirements can be found at this
website as well as available QA training and
information about the annual EPA QA meeting.

-------
&EPA
    United States
    Environmental Protection
    Agoncy

   Office of Ground Water and Drinking Water
   Cincinnati, OH 45268
   EPA-815-N-02-001a
   January 2002
PRESORTED STANDARD
 POSTAGE & FEES PAID
         EPA
   PERMIT NO. G-35
   Official business
   Penalty for Private Use
   S300
                         In This Issue,..

                         S  NELAC 7 Highlights
                         /  More Contaminants Require
                             Certification
                         S  New PT Acceptance Criteria for
                             THMs
                         S  More on Proficiency Testing
                             Requirements
                         i/  Some Useful Websites
                            Recycled/Recyclable
                            Printed with vegetable-based ink on paper that
                            contains a minimum of 50% post-consumer fiber
                            and is processed chlorine free.

-------