Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices 8529 

respondent (i.e., an annual average of 

11,238 hours of burden divided among 

an annual average of 22 facilities). For 

new offshore oil and gas extraction 

facilities, the permitting process is 

handled directly by EPA Regions 4, 6, 

and 10. Since this burden is incurred by 

the Federal Government rather than the 

States, it is not included as part of the 

burden statement for State Directors. 

The ICR provides a detailed 

explanation of the Agency’s estimate for 

the existing ICR, which is only briefly 

summarized here: 

Estimated Total Number of Potential 

Respondents: 22 facilities. 

Frequency of Response: Every five 

years. 

Estimated Total Average Number of 

Responses for Each Respondent: 22. 

Estimated Total Annual Burden 

Hours: 11,238 hours. 

Estimated Total Annual Costs: 

$1,157,139. This includes an estimated 

labor burden cost of $581,714 and an 

estimated cost of $575,425 for capital 

investment or maintenance and 

operational costs. 

The revised ICR is expected to have 

burden change related to universe 

fluctuations and increased labor rates. 

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 6, 2009. 

James A. Hanlon, 

Director, Office of Wastewater Management. 

[FR Doc. E9–4006 Filed 2–24–09; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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: 

miller.carrie@epa.gov. 

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 


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8530 Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices 

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, Statebased 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 


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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 


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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 offsite 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: 


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• 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 


pwalker on PROD1PC71 with NOTICES
8534 Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices 

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 startup 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OECA–2009–0124; FRL–8776–5] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Auto-Body 

Compliance Assessment Pilot Project; 

EPA ICR No. 2344.01, OMB Control No. 

2009–NEW 

AGENCY: Environmental Protection 

Agency. 

ACTION: Notice. 

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 for a new Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB). If 

approved, the ICR would allow EPA to 

pilot in EPA Region 1 (New England) an 

approach to assessing the effectiveness 

of compliance assistance in improving 

environmental performance. The ICR 

would authorize the administration of 

surveys, by telephone and on-site, to a 

random sample of auto-body shops 

subject to Subpart HHHHHH National 

Emission Standards for Hazardous Air 

Pollutants: Paint Stripping and 

Miscellaneous Surface Coating 

Operations at Area Sources (NESHAP 

Subpart HHHHHH). Before submitting 

the ICR to OMB for review and 

approval, EPA is soliciting comments on 

specific aspects of the proposed 

information collection as described 

below. 

DATES: Comments must be submitted on 

or before April 27, 2009. 

ADDRESSES: Submit your comments 

identified by Docket ID No. EPA–HQ– 

OECA–2009–0124. While EPA 

encourages electronic submittals, you 

can submit comments by any one of the 

following methods: 

• http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

• E-mail: harmon.kenneth@epa.gov. 

• Fax: (202) 564–7083. 

• Mail: Environmental Protection 

Agency, Mailcode: 2224A, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460. 

• Hand Delivery: EPA Docket Center, 

EPA West Room 3334, 1301 

Constitution Ave., NW., 20460. 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–OECA–2009– 

0124. 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 through http:// 

www.regulations.gov or e-mail. The 

http://www.regulations.gov website 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 


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