[Federal Register Volume 74, Number 36 (Wednesday, February 25, 2009)]
[Notices]
[Pages 8529-8534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4009]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2002-0011; FRL-8776-6]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Laboratory Quality Assurance Evaluation Program for 
Analysis of Cryptosporidium Under the Safe Drinking Water Act 
(Renewal); EPA ICR No. 2067.04, OMB Control No. 2040-0246

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44 
U.S.C. 3501 et seq.), this document announces that EPA is planning to 
submit a request to renew an existing approved Information Collection 
Request (ICR) to the Office of Management and Budget (OMB). This ICR is 
scheduled to expire on May 31, 2009. This notice describes the current 
``Laboratory Quality Assurance Evaluation Program for Analysis of 
Cryptosporidium under the Safe Drinking Water Act,'' hereafter referred 
to as the ``Lab QA Program,'' and requests comment on both the program 
and the renewed paperwork requirements.

DATES: Comments must be submitted on or before April 27, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2002-0011, by one of the following methods:
     http://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     Mail: Water Docket, Environmental Protection Agency, 
Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery: Monday through Friday, excluding legal 
holidays. The telephone number for the Reading Room is (202) 566-1744, 
and the telephone number for the Water Docket is (202) 566-2426. Such 
deliveries are only accepted during the Docket's normal hours of 
operation, and special arrangements should be made for deliveries of 
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2002-
0011. EPA's policy is that all comments received will be included in 
the public docket without change and may be made available online at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected using http://www.regulations.gov or e-mail. Please contact EPA prior to submitting 
CBI. The http://www.regulations.gov Web site is an ``anonymous access'' 
system, which means EPA will not know your identity or contact 
information unless you provide it in the body of your comment. If you 
send an e-mail comment directly to EPA without going through http://www.regulations.gov your e-mail address will be automatically captured 
and included as part of the comment that is placed in the public docket 
and made available on the Internet. If you submit an electronic 
comment, EPA recommends that you include your name and other contact 
information in the body of your comment and with any disk or CD-ROM you 
submit. If EPA cannot read your comment due to technical difficulties 
and cannot contact you for clarification, EPA may not be able to 
consider your comment. Electronic files should avoid the use of special 
characters, any form of encryption, and be free of any defects or 
viruses. For additional information about EPA's public docket visit the 
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Carrie Miller, EPA, Office of Ground 
Water and Drinking Water, Technical Support Center, 26 West Martin 
Luther King Drive (MS-140), Cincinnati, Ohio 45268; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    EPA has established a public docket for this ICR under Docket ID 
No. EPA-HQ-OW-2002-0011, which is available for online viewing at 
http://www.regulations.gov, or in person viewing at the Water Docket in 
the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution 
Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from 
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Reading Room is 202-566-1744, 
and the telephone number for the Water Docket is 202-566-2426.
    Use http://www.regulations.gov to obtain a copy of the draft 
collection of information, submit or view public comments, access the 
index listing of the contents of the docket, and to access those 
documents in the public docket

[[Page 8530]]

that are available electronically. Once in the system, select 
``search,'' then key in the docket ID number identified in this 
document.

What Information Is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically 
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the Agency, 
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden 
of the proposed collection of information, including the validity of 
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information 
to be collected; and
    (iv) Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses. In particular, EPA is requesting comments from 
very small businesses (those that employ less than 25) on examples of 
specific additional efforts that EPA could make to reduce the paperwork 
burden for very small businesses affected by this collection.
    EPA is also interested in any other comments regarding the 
improvements to the Lab QA Program described in this notice.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible and provide specific 
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified 
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

What Information Collection Activity or ICR Does This Apply to?

    Affected entities: Entities potentially affected by this action are 
public and private water testing laboratories. EPA estimates that a 
total of 65 laboratories will seek to attain or maintain EPA 
recognition under the Lab QA Program. This estimate includes 63 
laboratories seeking continued recognition under the Lab QA Program and 
2 laboratories seeking initial recognition.
    Title: Laboratory Quality Assurance Evaluation Program for Analysis 
of Cryptosporidium under the Safe Drinking Water Act (Renewal).
    ICR numbers: EPA ICR No. 2067.04, OMB Control No. 2040-0246.
    ICR status: This ICR is currently scheduled to expire on May 31, 
2009. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information, unless it displays 
a currently valid OMB control number. Approved OMB control numbers for 
EPA's regulations in title 40 of the CFR are listed in 40 CFR part 9 of 
the Federal Register and displayed either by publication of the Federal 
Register or by other appropriate means, such as on the applicable 
collection instrument or form.
    Abstract: In September 2000, the Stage 2 Microbial and Disinfection 
Byproducts Federal Advisory Committee (Committee) signed an Agreement 
in Principle (Agreement) (65 FR 83015, December 29, 2000) (EPA, 2000) 
with consensus recommendations for two future drinking water 
regulations: the Long Term 2 Enhanced Surface Water Treatment Rule 
(LT2ESWTR) and the Stage 2 Disinfectants and Disinfection Byproducts 
Rule. The LT2ESWTR was to address risk from microbial pathogens, 
specifically Cryptosporidium. The Committee recommended that the 
LT2ESWTR require public water systems (PWSs) to monitor their source 
water for Cryptosporidium using EPA Method 1622 or EPA Method 1623. 
Additional Cryptosporidium treatment requirements for PWSs would be 
based on the source water Cryptosporidium levels. EPA took into account 
the Committee's advice and recommendations as it developed the 
LT2ESWTR, which was published on January 5, 2006.
    Under the LT2ESWTR, EPA requires public water systems to use 
approved laboratories when conducting Cryptosporidium monitoring. In 
the preamble to the LT2ESWTR as well as several other notices, EPA has 
described the criteria for approval of laboratories to analyze 
Cryptosporidium samples under the LT2ESWTR. See 71 FR 727 (January 5, 
2006) and 67 FR 9731 (March 4, 2002). The Lab QA Program, as revised, 
is described in this notice. The purpose of the Lab QA Program is to 
identify laboratories that can reliably measure for the occurrence of 
Cryptosporidium in surface water and to ensure that approved 
laboratories maintain that capability. Other, State-based laboratory 
oversight programs do not currently address approval of laboratories 
for the Cryptosporidium analysis required by the LT2ESWTR.
    Through today's notice, EPA is inviting comment on refinements to 
the information collected to support EPA's Lab QA Program. As of May 
2007, EPA concluded that sufficient laboratory capacity exists for the 
LT2ESWTR. As a result, EPA has generally postponed evaluation of 
additional laboratories, including commercial, county, municipal and 
utility laboratories, until further notice. Subject to the availability 
of resources, EPA will consider evaluation of State and EPA Regional 
laboratories on a case-by-case basis, based on the role that States and 
EPA Regions play in the certification and approval programs for 
laboratories. The Lab QA Program is continuously being refined and 
updated as new information and technologies become available. The 
program will continue to evolve and EPA will continue to revise and 
update burden estimates, as needed, with any subsequent ICR.
    Approved laboratories will have demonstrated, and are to continue 
to demonstrate, proficient and reliable detection and enumeration of 
Cryptosporidium in surface water sources for public water systems. They 
will have passed all elements in the Lab QA Program and continue to 
successfully participate in all program activities. Approved 
laboratories are responsible for notifying EPA of losses of key 
personnel or essential equipment and changes in policies or procedures 
that directly affect the validity of data or any other change affecting 
the capability of the laboratory including change in location. 
Participating laboratories are to also demonstrate ongoing capability 
and method performance by following all applicable method quality 
control (QC) procedures, analyzing ongoing proficiency testing (PT) 
samples (generally three times per year), submitting requested data to 
EPA, and participating in periodic re-evaluations.
    The Lab QA Program procedures have been updated to reflect that the 
minimum recovery for Cryptosporidium

[[Page 8531]]

in ongoing precision and recovery (OPR) samples is now 22 percent, 
updated from the original 11 percent. This updated minimum recovery is 
based on an updated data set and should provide a better assessment of 
laboratory performance than the original value for the following 
reasons: (1) The data set is more current and is based on more samples 
(a total of 333); (2) 52 more laboratories are included in the data 
set; (3) data were generated using the 2005 version of Method 1623, 
which is the required version for LT2ESWTR analyses; (4) data were 
generated using filters currently used to analyze LT2ESWTR samples 
rather than those filters used originally; and (5) the number of 
oocysts spiked into the samples was unknown to the laboratories. 
Calculations for the updated criteria are available in Docket ID No. 
EPA-HQ-OW-2002-0011. Laboratories are to now document a minimum of 22 
percent recovery for OPR samples in an updated QC chart prior to 
analysis of LT2ESWTR samples at the frequency required in section 9.7 
of the method.
    The ongoing PT sample packets generally consist of three spiked 
samples shipped to the laboratory within a standard matrix. If a 
laboratory submits poor PT results, EPA may recommend additional 
follow-up action to demonstrate that the laboratory's performance 
remains acceptable. Additional actions may include submission of PT 
slides to EPA, repeat analyses, providing additional QC data, and 
investigation of problems with reagents and equipment. Repeated failure 
to demonstrate laboratory capability and acceptable method performance 
may result in suspension or downgrading of approval status as outlined 
later in this section.
    EPA may re-evaluate laboratories participating in the program to 
verify Cryptosporidium laboratory quality assurance (QA) on both an 
``as-needed'' and periodic basis (generally not exceeding once every 
three years). In the case of a periodic assessment, EPA will generally 
notify the laboratory that they are due for re-evaluation and request a 
package with documentation of personnel status, equipment maintenance, 
standard operating procedures, training records, and QC charts. After 
the package has been received, it will be evaluated for completeness. 
EPA generally contacts the laboratory within 15 days of package 
submission if information is missing. When a complete package has been 
received, the following steps will complete the process:
    1. The laboratory will send positive staining control and OPR 
slides for evaluation by EPA.
    2. The laboratory will order blind slides spiked with 
Cryptosporidium from a qualified vendor for each analyst. Each analyst 
will perform an independent count of one slide. The results and slides 
will be submitted to a technical auditor.
    3. EPA will schedule an on-line Internet analyst verification of 
performance for microscopists to demonstrate their ability to identify 
Cryptosporidium oocysts.
    4. EPA conducts a one-day on-site evaluation that will primarily 
focus on method performance and data recording. Laboratory personnel 
will be asked to order blind oocyst suspensions for use in sample and 
IMS control spiking in the presence of an auditor, and then complete 
the analyses within applicable method holding times and send results to 
EPA.
    5. EPA will send the laboratory a report detailing all findings, 
generally within 60 days after the evaluation is complete. The 
laboratory is then asked to provide written responses to any 
deficiencies identified in the report within 60 days. Provided all 
responses to the deficiencies cited in the report are acceptable, the 
Lab QA Program will then base its decision for continued laboratory 
approval on PT results, quality of the positive control and OPR slide, 
slide counts, Internet analyst verification, on-site evaluation and 
recovery values for blind analyses initiated during the on-site 
evaluation.
    State and EPA Regional Laboratories may contact the laboratory 
approval manager regarding new application submissions. Subject to 
available resources, EPA estimates that up to two State or EPA Regional 
Laboratories will seek first-time approval each year. Laboratories 
seeking approval under the program must submit an application package 
and provide: a demonstration of availability of qualified personnel and 
appropriate instrumentation, equipment and supplies; detailed 
laboratory standard operating procedures; a current copy of the table 
of contents of their laboratory's QA plan for protozoa analyses; and an 
initial demonstration of capability data for EPA Method 1623, which 
includes initial precision and recovery IPR test results and matrix 
spike/matrix spike duplicate (MS/MSD) test results for Cryptosporidium. 
After EPA completes its review of the application, the Agency will 
contact the laboratory for follow-up information and to schedule 
shipment of initial PT samples consisting of eight spiked samples 
within a standard matrix. EPA then generally conducts an on-site 
evaluation and data audit. Further information is provided at http://www.epa.gov/safewater/disinfection/lt2/lab_home.html. The Agency notes 
that completion of an application by a laboratory does not ensure that 
the Agency will act on the laboratory's request; interested 
laboratories are encouraged to contact the laboratory approval manager 
prior to investing substantial effort towards their application. 
Further, a decision by the Agency to review an application, to send 
initial PT samples, and/or to schedule or conduct an on-site evaluation 
and data evaluation, does not ensure that the review process will be 
completed or that the laboratory will ultimately be approved. Decisions 
will be made based on the facts associated with a particular 
application and actions will be taken as Agency resources permit.
    Approved laboratories that do not continue to meet the criteria for 
the Lab QA Program may have their status downgraded to provisional or 
have their approval suspended. Details of the basis for downgrading or 
suspending a laboratory's approval are provided in the section entitled 
``Clarification of Basis and Procedures for Downgrading/Suspending 
Approval for Laboratories for the Analysis of Cryptosporidium in Water 
Under the Long Term 2 Enhanced Surface Water Treatment Rule'' (see the 
following section). Provided EPA has sufficient resources to review 
requests for upgrade or reinstatement, laboratories may have to 
undertake additional activities such as analyzing additional PT 
samples, undergoing an on-site evaluation, and/or counting blind spiked 
slides in order to have their status upgraded or their approval 
reinstated. Details regarding additional activities that may be 
required are provided in the next section.

Clarification of Basis and Procedures for Downgrading/Suspending 
Approval of Laboratories for the Analysis of Cryptosporidium in Water 
Under the Long Term 2 Enhanced Surface Water Treatment Rule

    EPA's Office of Ground Water and Drinking Water, in the Office of 
Water, has developed a detailed description of the procedures and 
criteria used in actions concerning approving, downgrading and 
suspending laboratories for analysis of drinking water contaminants.
    In order to assume primary enforcement responsibility for the 
drinking water regulations, a State must either have available 
laboratory facilities, approved by the

[[Page 8532]]

Administrator, capable of conducting analytical measurements of 
drinking water contaminants, or establish and maintain its own program 
for approval of laboratories. States wishing to adapt these procedures 
and criteria for their own approval program should revise it to 
accurately reflect their State approval program.
    This section is intended to clarify EPA's intended practices and 
procedures for laboratory approval, downgrading or suspension for 
analysis of Cryptosporidium under the Long Term 2 Enhanced Surface 
Water Treatment Rule (LT2ESWTR) and to reflect good laboratory practice 
and standard proficiency evaluation in the industry; it is not a 
regulation. While EPA intends to generally follow the procedures laid 
out in this section, not every situation is reflected in these 
procedures and EPA may need to address case-specific situations in ways 
that differ from the procedures spelled out here. EPA welcomes comment 
on these procedures and may decide to revise them at any time in the 
future to reflect changes to its approach or to clarify and update the 
text.
     ``Approved Laboratories'' have demonstrated, and continue 
to demonstrate, proficient and reliable detection and enumeration of 
Cryptosporidium in surface water sources for public water systems. They 
have passed all elements in the Lab QA Program and continue to 
successfully participate in all program activities. Approved 
Laboratories notify the Approval Authority (EPA individual(s) 
administering the program or State individual(s) administering an 
equivalent laboratory certification program) of loss of key personnel 
or essential equipment, change in policies or procedures that directly 
affect the validity of data, and any other change affecting the 
capability of the laboratory including change in location.
     ``Provisionally Approved Laboratories'' have deficiencies 
but demonstrate their ability to consistently produce data of known 
quality. They continue to successfully participate in all Lab QA 
Program activities. A Provisionally Approved Laboratory may analyze 
drinking water samples for LT2ESWTR compliance purposes if the 
laboratory has identified themselves as provisionally approved to their 
clients and any reports clearly state that the laboratory's status is 
``provisionally approved.''
     ``Not Approved'' designates a laboratory that has either 
not participated in the Lab QA Program, or has applied to the program 
but possesses deficiencies and, in the opinion of the Approval 
Authority, does not consistently produce data that has met all 
applicable method QC requirements or has falsified data.

Basis for Downgrading to ``Provisionally Approved'' Status

    An Approved Laboratory (referred to as ``laboratory'') may be 
downgraded to ``Provisionally Approved'' status for Cryptosporidium for 
any of the following reasons:
     Failure to analyze samples for the LT2ESWTR according to 
the December 2005 version of EPA Method 1623 or EPA Method 1622, 
including all QA/QC criteria;
     Failure to document a minimum of 22 percent for on-going 
precision and recovery values in an updated QC chart prior to analysis 
of LT2ESWTR samples at the frequency required in section 9.7 of the 
method;
     Failure to demonstrate proficiency based upon acceptable 
matrix spike recoveries for all modifications of the method procedures 
per Section 9.1.2 of the method;
     Failure to submit valid Proficiency Test (PT) results or 
meet PT acceptance limits described by the Approval Authority for the 
first two initial testing events or two out of three regular testing 
events administered by a vendor authorized by the Approval Authority. 
The acceptance limits are laboratory mean recovery between 2 standard deviations (SD) of the mean recovery for all approved 
laboratories in a given test event. Recoveries below the mean recovery 
minus 2 SD will fail the PT test event. Recoveries higher than the mean 
recovery plus 2 SD trigger additional evaluation, which may include one 
or more of the following: (1) On-site evaluation; (2) presence of a 
proctor when processing PT samples during the next test event; and/or 
(3) submission of PT microscope slides to the Approval Authority before 
the expiration of holding time during the next test event;
     Failure to submit PT slides within three weeks of PT test 
event when requested by the Approval Authority;
     Failure to maintain records of method modifications per 
section 9.1.2.2 of the method;
     Failure to notify the Approval Authority of loss of key 
personnel or essential equipment, change in policies or procedures that 
directly affect the validity of data, or other changes affecting the 
capability of the laboratory including change in location. Laboratory 
Approval does not automatically survive such changes; the Approval 
Authority may request an on-site or off-site evaluation and/or further 
proof of compliance with all applicable method requirements;
     Failure to submit on-site evaluation materials and any 
other requested information within the time period requested by the 
Approval Authority; or
     Failure to participate satisfactorily in the Approval 
Authority Lab QA Program and demonstrate proficiency based upon: Sample 
and method holding time records; analyst verification skills; relative 
quality of positive staining control and on-going precision recovery 
(OPR) slides; acceptable performance of QC checks, including but not 
limited to blind slide counts; and acceptable precision and recovery 
values for all method variations.

Procedures for Downgrading to ``Provisionally Approved'' Status

     The Approval Authority will notify the laboratory director 
or owner of its intent to downgrade after becoming aware of the 
situation warranting downgrading;
     The laboratory director should review the problems cited, 
and within 30 days of receipt of the letter, send a letter to the 
Approval Authority specifying immediate corrective actions that are 
being taken;
     The Approval Authority will consider the adequacy of the 
response and notify the laboratory in writing of its approval status, 
generally within 14 days of receipt of the laboratory's response;
     After the Approval Authority notifies a laboratory, the 
Approval Authority will post status on the Web site list of 
laboratories and may schedule an on-site evaluation of the laboratory;
     The laboratory should identify and correct its problem(s) 
to the Approval Authority's satisfaction within 30 days of being 
notified of the downgrade or have approval status suspended;
     A Provisionally Approved laboratory may continue to 
analyze samples for compliance purposes, but must identify its status 
as Provisionally Approved on any report;
     A laboratory may request that the Approval Authority or 
State provide technical assistance to help identify and resolve any 
problem; however, adequate performance is the laboratory's 
responsibility and Approval Authority assistance should not delay the 
downgrading procedure.

Basis for Suspending Approval Status

    A laboratory may be downgraded from Approved or Provisionally 
Approved status to ``Not Approved'' for any of the following reasons:

[[Page 8533]]

     Repeated verification that all applicable method QC 
requirements have been followed, when in fact they have not all been 
met;
     Repeated failure to document acceptable OPR values prior 
to analysis of LT2ESWTR samples;
     Reporting PT data from another laboratory as its own;
     Falsification of data or other deceptive practices 
including false verification that data submitted to the Data Collection 
and Tracking System (DCTS) was generated using approved methods and met 
all method QA/QC criteria;
     Refusal to participate in on-site or off-site evaluations 
conducted by the Approval Authority.

Basis for Suspending Provisionally Approved Status

     Failure to provide a letter to the Approval Authority 
within 30 days that adequately explains what immediate corrective 
actions were taken;
     Failure to identify and correct problems in response to 
downgrade within 30 days;
     Failure to provide accurate OPR control charts to the 
Approval Authority;
     Failure to submit valid PT results for the next two 
consecutive authorized PT test events within the acceptance limits 
specified;
     Continued failure to use the analytical methodology 
specified in the regulations;
     Failure to correct deviations identified during an on-site 
evaluation within 30 days; or
     Failure to provide requested demonstration, materials and 
documentation within 30 days, including: acceptable matrix spike 
recoveries for all method variations per section 9.1.2 of the method; 
bench sheets, examination forms or OPR charts for any samples 
requested; remote analyst verification; recent positive staining 
control and OPR microscope slides, one of each; and blind slide counts 
for each analyst.

Procedures for Suspension

    The Approval Authority will notify the laboratory, in writing, of 
its intent to suspend approval. If the laboratory wishes to request 
reconsideration of this decision, it should submit such a request in 
writing to the Approval Authority within 30 days of receipt of the 
notice of intent to suspend approval. The laboratory will generally be 
downgraded immediately to ``provisional approval'' in the interim while 
the suspension is being considered. If no request for reconsideration 
is filed, approval will be suspended.
    The request for reconsideration should be supported with an 
explanation of the reasons for the challenge and should be signed by a 
responsible official from the laboratory such as the president/owner 
for a commercial laboratory, the laboratory supervisor of a municipal 
laboratory, or the laboratory director for a State or Regional 
laboratory.
    The Approval Authority will make a decision and notify the 
laboratory in writing, generally within 30 days of receipt of the 
request for reconsideration. If the request is determined to be valid, 
the Approval Authority will take appropriate measures to reevaluate the 
facility and notify the laboratory, in writing, of its decision, 
generally within 60 days of the reevaluation.
    Denial of the request will generally result in suspension of the 
laboratory's approval. Once approval is suspended, a public water 
system may not use the laboratory to analyze source water samples for 
compliance with LT2ESWTR source water monitoring requirements. The 
laboratory should notify its clients that it is no longer approved and 
will not accept any more LT2ESWTR samples for analysis.

Upgrading or Reinstatement of Approval

    Subject to the availability of resources, the Approval Authority 
will consider written requests from the laboratory to seek upgrading or 
reinstatement of approval. Requests should state the reasons why the 
laboratory should regain its approval status. The laboratory should 
demonstrate that all deficiencies have been corrected and successfully 
complete two consecutive authorized PT test events within acceptance 
limits for Provisionally Approved laboratories or three consecutive 
authorized PT test events within acceptance limits for suspended 
laboratories. The authorized PT test events being described here are 
those submitted to all laboratories in the Lab QA Program, not special 
issue blind samples purchased independently from the vendor. The 
laboratory should provide evidence why the reasons for downgrading or 
suspension are no longer applicable and explain its technical 
competence. Acceptable demonstration of technical competence may 
include an on-site evaluation and/or any other measure the Approval 
Authority deems appropriate. The Approval Authority will consider 
compliance history, corrective actions implemented by the laboratory, 
effectiveness of corrective actions, and professional judgment of the 
Approval Authority.

Grievances

    Laboratories with grievances during the authorized PT events or 
regarding participation in the Lab QA Program should immediately 
contact the Program Manager at the Approving Authority and try to 
remedy the problem. When the laboratory feels they have not gotten 
immediate or satisfactory results, they should contact the supervisor 
at the Approving Authority. The management at the Approving Authority 
will work with the Program Manager to quickly address grievances. A 
final decision for all grievances will be made generally within 30 days 
of contacting the Approving Authority.

Request for Comment

    The EPA is soliciting comments on this notice to:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the Agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the Agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. Minimize the burden of the collection of information on those 
who are to respond, including through use of appropriate automated 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses; and
    5. Consider any necessary changes to the Lab QA Program. As an 
example, EPA is particularly interested in comments from States 
regarding the potential for their laboratory programs to assume any/all 
responsibility for the approval and oversight of LT2ESWTR laboratories, 
including comments on the appropriate timeframes for such. The Agency 
also welcomes comments regarding the appropriateness of turning to 
commercial PT providers as the source of PT samples for laboratories, 
in lieu of the PT program currently administered by the Agency.
    Burden Statement: The burden estimate for the Lab QA Program 
information collection includes all the burden hours and costs required 
for gathering information, and developing and maintaining records 
associated with the Lab QA Program. An estimated 65

[[Page 8534]]

respondents will participate in an average of 4.4 responses per year to 
include: analysis and reporting of PT samples three times per year, 
application for initial or re-audit once every three years, off-site 
re-evaluation activities once every three years, and on-site evaluation 
once every three years. A small subset of laboratories will perform 
follow-up activities based on inadequate QA/QC, failed OPRs, incomplete 
records, delayed communication to EPA or poor PT results. A few 
laboratories perform more than one method version and will analyze an 
additional set of PT samples three times per year. The total annual 
public reporting and recordkeeping burden for this collection of 
information is estimated to be 4843 hours at a cost of $269,800.40. The 
average hours and cost per response for the average of 4.4 responses 
per year are 16.9 hours and $943.36, respectively. These estimates 
assume that laboratories participating in the Lab QA Program have the 
necessary equipment needed to conduct the analyses. Therefore, there 
are no start-up costs. The estimated total annual capital cost is 
$0.00. The total estimated Operation and Maintenance (O&M) costs is 
$141,929.00.
    The ICR provides a detailed explanation of the Agency's estimate, 
which is only briefly summarized here:
    Estimated Total Number of Potential Respondents: 65.
    Frequency of Response: Annual.
    Estimated Total Average Number of Responses for Each Respondent: 
4.4.
    Estimated Total Annual Burden Hours: 4843 hours.
    Estimated Total Annual Costs: $411,729.40. This includes an 
estimated burden cost of $269,800.40 and an estimated cost of 
$141,929.00 for capital investment or maintenance and operational 
costs.

Are There Changes in the Estimates From the Last Approval?

    Changes in burden have occurred due to inflation, re-evaluation of 
hours for tasks, and improved demonstration of capability. Inflation 
has increased all operation and maintenance and labor costs 
accordingly. The increase in the respondent universe has increased the 
overall burden costs for the respondents. EPA's original estimates for 
hours to participate and maintain the Lab QA Program were made before 
the program began. Because the program has matured and several years of 
QC data have been collected, the burden has changed for performing 
improved and refined procedures. The burden for some tasks has been 
estimated and will be re-evaluated as the program progresses. EPA has 
added the preceding section entitled ``Clarification of Basis and 
Procedures for Downgrading/Suspending Approval for Laboratories for the 
Analysis of Cryptosporidium in Water Under the Long Term 2 Enhanced 
Surface Water Treatment Rule.'' Some approved laboratories may have to 
undertake additional activities to demonstrate continued acceptable 
performance to EPA, which may increase the burden of participation in 
the Lab QA Program for those laboratories. EPA estimates that nine 
laboratories per year may have to undertake additional activities to 
demonstrate acceptable performance to EPA. These estimates will be 
corrected as the program continues.

What is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as 
appropriate. The final ICR package will then be submitted to OMB for 
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will 
issue another Federal Register notice pursuant to 5 CFR 
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the 
opportunity to submit additional comments to OMB. If you have any 
questions about this ICR or the approval process, please contact the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: February 19, 2009.
Cynthia C. Dougherty,
Director, Office of Ground Water and Drinking Water.
 [FR Doc. E9-4009 Filed 2-24-09; 8:45 am]
BILLING CODE 6560-50-P