Recent Legislation
Michella Karapondo
U.S. Environmental Protection Agency
Drinking Water Program Update
December 2006
OGWDW, TSC
Office of Ground Water and Drinking Water
What do we do?
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Develop drinking water regulations
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Set drinking water standards
Proficiency testing criteria
Approve drinking water methods
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Evaluate and develop analytical methods
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Implement laboratory certification program
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Alternate testing procedures (ATPs)
Radiochemistry audits
NELAC
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National Environmental Laboratory Accreditation
Conference (NELAC)
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OGWDW endorsement of NELAC
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2002 letter from OGWDW supports use of
NELAC standard
Drinking water accreditation must
be as stringent as USEPA’s
certification
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Certification by method AND analyte vs.
technology/analyte or analyte group
Drinking water requires use of defined
methods
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Performance based methods are NOT ALLOWED!
New methods allow for some laboratory flexibility
Proficiency Testing (PT) Program for
Drinking Water
NIST/NVLAP
USEPA Criteria Document
EPA -set
standards
A2LA
Accredits providers
PT Providers
Analyze PT Samples
Laboratories
Conducts PT Studies
CO/AA - Reviews PT Results
Note that EPA terminology is different – Performance Evaluation – PE Study
Where can I find PT criteria?
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Regulatory acceptance limits are in the CFR
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Called “Performance Evaluation” in the CFR
{ Inorganic criteria: 40 CFR 141.23(k)(3)(ii)
{ VOC criteria: 40 CFR 141.24(f)(17)(i) and (ii) for
vinyl chloride
{ SOC criteria: 40 CFR 141.24(f)(19)(i)(B)
{ Lead/copper criteria: 40 CFR 141.89(a)(1)(ii)(A)
and (B)
{ DBP criteria: 40 CFR 141.131(b)(2) – NOTE that
the 2005 CFR does not have the updated DBP
criteria!
NELAC FoPT Tables
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http://www.epa.gov/nelac/pttables.html
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Radiochemistry Audits for EPA Region,
State and Tribal Laboratories
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TSC currently supports through
extramural monies
State laboratories needing
certification are currently audited
using a contractor
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May not be an option in the near future
We are working with the regions to
find alternate funding
Drinking Water Methods
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Developed by TSC and ORD
Other government agencies
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USGS
Review methods from voluntary consensus
method standard bodies
ASTM, Standard Methods, AOAC
Approved through the
regulatory process
Evaluating Methods:
The Alternate Testing Program
40 CFR 141.27 allows “alternate analytical techniques”
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MUST have written permission from EPA
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A letter from EPA OR
Publication in the Federal Register
ATPs are national – there are no lab specific
ATPs for drinking water
For drinking water protocol, call Sample
Control Center at 703-461-2100
Questions? Contact [email protected]
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Alternate Testing Program (ATP)
Method subm itted to EPA
Evaluated by Technica l Staff
Is the m ethod
suitable for
Drinking
Water?
No
Letter sent to subm itter
rejecting method
Yes
Is the m ethod
equiva lent to
an approved
DW m ethod?
Yes
Letter issued stating method
m ay be used
No
Method is proposed in Federal
Register
ATP letters will be posted on OGWDW’s web site
Where can I find approved methods?
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Approved methods are listed in CFR
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BUT, the CFR is published only once a year!
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Keep an eye on the Federal Register!
Approved methods are listed on OGWDW’s web
site
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Inorganic methods: 40 CFR 141.23
Organic methods: 40 CFR 141.24
Methods for radioactivity: 40 CFR 141.25
Lead and copper: 40 CFR 141.89
Disinfection by-products: 40 CFR 141.131
http://www.epa.gov/safewater/methods/methods.html
Some EPA methods are available in PDF format
National Environmental Monitoring Index (NEMI)
National Environmental Monitoring Index (NEMI)
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Database of methods applicable for
monitoring water for chemical and
microbiological pollutants
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Useful for comparing/contrasting methods
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Caution! NEMI may not always contain
correct/approved version of method
Can search by analyte, matrix, CAS number,
and/or regulatory requirement
Public release October 2002 – announced by
joint USGS/USEPA letter
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NEMI Search – General
NEMI Search – By Regulation
Safe Drinking Water Act (SDWA)
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Authorizes EPA to set enforceable
health standards for contaminants in
drinking water
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affects all public water systems serving at
least 25 people or having at least 15
service connections
required that the National Primary Drinking
Water Regulations be drafted
amended in 1977, 1979, 1980, 1986, and
1996 (reauthorized and amended).
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How does OGWDW decide what to regulate?
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1996 SDWA amendments changed the
process
Contaminant Candidate List (CCL)
Unregulated Contaminant Monitoring (UCMR)
Regulatory Determination
Regulatory Promulgation
Regulatory Implementation
Six Year Review
Regulations
Proposal
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Public Comment
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Final Rule
Federal Register
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Published daily by the Office of Federal
Register (National Archives and Records
Administration – NARA)
Notices, Proposed & Final Rules
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Preamble
{ An explanation of rule
{ Contact person
{ Docket information
{ How to submit comments (for proposed rules)
Rule
{ The legal requirements
{ Only lists changes
Available on line at
http://www.gpoaccess.gov/fr/index.html
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Preamble to Proposed Methods Update Rule
FR Citation (69 FR 18166 April 6, 2004)
Language in Proposed Methods Update Rule
FR Citation (69 FR 18166 April 6, 2004)
* * * Indicates no change in current rule language
Dockets
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Proposed rule dockets contain supporting
documents & public comments
Final rule docket also has Agency response
to public comments
Docket number is listed in preamble
Electronic access to dockets at:
http://www.regulations.gov
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Want to know when something is published?
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Subscribe to EPA’s ListServer to receive
an email when a FR is published
relating to “water”
https://lists.epa.gov/read/all_forums/
Code of Federal Regulations (CFR)
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Codification of Federal Rules
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Rule language (no preamble)
50 titles - Drinking Water is Title 40
Published volumes are updated annually
Title 40 is updated on July 1
Incorporates all changes from previous year
Available on line at
http://www.gpoaccess.gov/cfr/index.html
e-CFR updated frequently (not official
version)
Radionuclides in Drinking Water
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1976 - First radionuclide regulations
promulgated
1986 - Amendments to SDWA
1991 – Proposed regulations and
revisions
1996 – Amendments to SDWA
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2000 – Final radionuclide rule
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Analytical Methods for Radionuclides
62 FR 10168 – March 5, 1997
Approved the use of 66 radionuclide
methods
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54 methods proposed in the 1991 radionuclide
proposed rule
12 methods from public comments to that
proposal
Full list of approved radionuclide methods
in 40 CFR 141.25
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Radon
64 FR 59246 - November 2, 1999 – Proposed Rule
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Will apply to community water systems using
ground water or mixed ground and surface
water
Multi-Media Mitigation program plans to
address indoor air along with water
Rn-222 MCL = 300pCi/L or AMCL = 4,000pCi/L
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first application of AMCL and MMM
Final rule 2007 or 2008 (or longer!)
Radionuclide Rule
65 FR 76708 - December 7, 2000 - Final Rule
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Retains previously regulated radionuclide
contaminants and adds requirements for Uranium
Applies to community water systems
Initial monitoring complete by December 31,
2007
Sets a new MCL for Uranium – 30 ug/L
Retains the existing MCLs for:
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Radium-226/228 – 5 pCi/L
Gross alpha particle radioactivity – 15 pCi/L
{ Includes Ra-226, but excludes radon and uranium
Beta particle and photon activity – 4 mrem/yr
Set all Maximum Contaminant Level Goals
(MCLGs) for radionuclides at 0 pCi/L
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Analytical Method for Uranium
69 FR 52176 - August 25, 2004
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Approves three ICP-MS methods for
Uranium
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EPA 200.8, revision 5.4
SM 3125 (20th edition)
ASTM D 5673-03
Method Update Rule
69 FR 18166 – April 6, 2004 – Proposed Rule
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OGWDW and OST
Updated versions of ASTM & SM methods
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Too many to list here
ATP methods
Micro ATP Protocol
EPA 327 – Chlorine dioxide
Proposed withdrawal of Atrazine immunoassay
Georgia Tech method for the
determination of Ra-226 and Ra-228 by
Gamma-ray Spectrometry
Final rule – 2006
Footnote 14: "The Determination of Radium226 and Radium-228 in Drinking Water by
Gamma-ray Spectrometry Using HPGE or
Ge(Li) Detectors," Revision 1.2, December
2004. Available from the Environmental
Resources Center, Georgia Institute of
Technology, 620 Cherry Street, Atlanta, GA
30332-0335, USA, Telephone: 404-894-3776.
This method may be used to analyze for
radium-226 and radium-228 in samples
collected after January 1, 2005 to satisfy the
radium-226 and radium-228 monitoring
requirements specified at 40 CFR 141.26.
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Resources
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OGWDW Website
http://www.epa.gov/safewater
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Drinking Water Regulations
http://www.epa.gov/safewater/regs.html
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Laboratory Certification
http://www.epa.gov/safewater/labcert
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Lab Cert Manual as PDF
http://www.epa.gov/safewater/labcert/labindex.html
Federal Register
http://www.gpoaccess.gov/fr/index.html
Resources
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PT Tables
http://www.epa.gov/nelac/pttables.html
Drinking Water Methods
http://www.epa.gov/safewater/methods/methods.html
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NEMI http://www.nemi.gov/
Radionuclide page
http://www.epa.gov/safewater/radionuc.html
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Implementation: USEPA Drinking
Water Certification Program
Michella Karapondo
U.S. Environmental Protection Agency
40
Topics
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Authority for certification program
Program structure and responsibilities
Certification process and criteria
Safe Drinking Water Act (SDWA)
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Authorizes EPA to set enforceable health
standards for contaminants in drinking water
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affects all public water systems serving at least 25
people or having at least 15 service connections
required that the National Primary Drinking Water
Regulations be drafted
amended in 1977, 1979, 1980, 1986, and 1996
(reauthorized and amended).
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Required By 40 CFR 141.28
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“… Samples may be considered only if
they have been analyzed by a laboratory
certified by the state except that
measurements for alkalinity, calcium,
conductivity, disinfectant residual,
orthophosphate, pH, silica, temperature,
and turbidity, may be performed by any
person acceptable to the state.”
Primary Enforcement Responsibility
40 CFR 141.28
A State has primacy when…
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it has adopted drinking water regulations no
less stringent than the Federal regulations
it has adopted and implemented adequate
procedures for enforcement of State
regulations
inventory of systems
sanitary surveys
{ establishes and maintains a certification
program and designates a CPM certified by
the Administrator responsible for the State
certification program
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USEPA Drinking Water Laboratory
Certification Program
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Program began in 1978
Hierarchical structure
Fundamentals are in the “Lab Cert
Manual”
Accept NELAP accreditation
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Certification Program Structure
USEPA
Office of Ground Water and Drinking Water
Regional Laboratory/Certification Program
State Laboratory & Certification Program
Private Laboratories
Certification Officers
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Should have a college degree in the
discipline for which they certify and have
recent laboratory experience
Should have experience in lab
evaluation and quality assurance
Successfully complete EPA's Certification
Officers training course
Scope of Certification
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Certification is granted in three areas:
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Chemistry
Microbiology
Radiochemistry
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Certification Process
Lab requests
(re)certification
Lab passes
PT sample
Lab certified for
3 years
On-site audit
performed
Set date for
on-site audit
On-site Evaluation Items
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Are promulgated/approved methods
being used and requirements of those
methods met
Are appropriate quality systems in place
Are personnel qualified and sufficient
Are laboratory facilities, equipment and
supplies adequate
Data audit
Types of Certification
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Certified
Provisionally certified
Not certified
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Interim certification
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Certified
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Laboratory meets the regulatory
performance criteria by:
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using promulgated/approved methods
demonstrating successful performance on
proficiency testing (PT) samples by analyte and
method on an annual basis
passing an on-site audit at least every 3 years
Must notify Certification Authority of any
major changes (personnel, equipment,
facility)
Provisional Certification
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Laboratory has minor deficiencies but is
still able to consistently produce valid data
using promulgated/approved methods
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insufficient/incomplete documentation
failed PT samples
Provisional Status
May continue to analyze compliance
samples; however:
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Must notify clients of status
For a limited time -- follow up is
needed to ensure corrective actions
have been completed or lab should be
decertified
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Not Certified
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Laboratory possesses deficiencies and cannot
consistently produce valid data
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has a lack of equipment/personnel
makes changes in method(s) that are not
allowed
is unresponsive to deficiencies found resulting in
provisional certification
Interim Certification
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Impossible or unnecessary to perform an
on-site audit
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for new contaminants
when no PT sample is available
when constraints prevent a timely on-site
audit
Lasts until next scheduled on-site or a PT
sample is available
More Drinking Water Lab Cert Information
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OGWDW Web site
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http://www.epa.gov/OGWDW/
TSC Lab Cert Team E-mail
addresses:
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[email protected]
[email protected] (micro)
[email protected]
[email protected]
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Web Sites
Laboratory Certification Manual, 5th Edition:
http://www.epa.gov/safewater/labcert/index.html
Methods (listed by contaminant/method number):
http://www.epa.gov/safewater/methods/methods.html
CFR:
http://www.gpoaccess.gov/cfr/index.html
DW REGS:
http://www.epa.gov/safewater/regs.html
List of state certified labs:
http://www.epa.gov/safewater/labs/index/html
Proficiency Testing Samples:
http://www.epa.gov/nelac/pttables.html
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