Document ID: EPA-HQ-OW-2002-0011-0043
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium, etc.
Posted Date: 2013-09-05T04:00Z

[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Notices]
[Pages 54643-54644]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21637]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2002-0011; FRL-9900-75-OW]

Proposed Information Collection Request; Comment Request; 
Laboratory Quality Assurance Evaluation Program for Analysis of 
Cryptosporidium Under the Safe Drinking Water Act (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an 
information collection request (ICR), ``Laboratory Quality Assurance 
Evaluation Program for Analysis of Cryptosporidium Under the Safe 
Drinking Water Act'' (EPA ICR No. 2067.05, OMB Control No. 2040-0246) 
to the Office of Management and Budget (OMB) for review and approval in 
accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). 
Before doing so, EPA is soliciting public comments on specific aspects 
of the proposed information collection as described below. This is a 
proposed extension of the ICR, which is currently approved through 
January 31, 2014. 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.

DATES: Comments must be submitted on or before November 4, 2013.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2002-0011, online using www.regulations.gov (our preferred method), by 
email to ow-docket@epa.gov, or by mail to: EPA Docket Center, 
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania 
Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the 
public docket without change including any personal information 
provided, unless the comment includes profanity, threats, information 
claimed to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Carrie Miller, Technical Support 
Center (TSC), Office of Ground Water and Drinking Water, (MS-140), 
Environmental Protection Agency, 26 West Martin Luther King Drive, 
Cincinnati, Ohio 45268; telephone number: 513-569-7919; fax number:

[[Page 54644]]

513-569-7191; email address: miller.carrie@epa.gov.

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail 
the information that the EPA will be collecting are available in the 
public docket for this ICR. The docket can be viewed online at 
www.regulations.gov or in person at the EPA Docket Center, EPA West, 
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone 
number for the Docket Center is 202-566-1744. For additional 
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act, 
EPA is soliciting 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. 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. At that time, EPA will issue another Federal Register notice 
to announce the submission of the ICR to OMB and the opportunity to 
submit additional comments to OMB.
    Abstract: Under the Long Term 2 Enhanced Surface Water Treatment 
Rule (LT2ESWTR), EPA requires public water systems to use approved 
laboratories when conducting Cryptosporidium monitoring. 40 CFR 
141.705(a) provides for approval of Cryptosporidium laboratories by 
``an equivalent'' State laboratory certification program (i.e., 
equivalent to EPA's Laboratory Quality Assurance Evaluation Program). 
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 74 FR 8529 (February 
25, 2009), 71 FR 727 (January 5, 2006) and 67 FR 9731 (March 4, 2002).
    Through today's notice, EPA is inviting comment on refinements to 
the information collected to support EPA's Lab QA Program. The 
procedures for Methods 1622, 1623, and 1623.1 (a revision of Method 
1623) have been updated to reflect that the minimum recovery for 
Cryptosporidium in ongoing precision and recovery (OPR) samples is now 
33 percent. This minimum recovery is based on an updated data set and 
should provide a better assessment of laboratory performance than the 
previous value for the following reasons: (1) The data set is more 
recent; and (2) the sample size is more than twice as large as the 2009 
sample size used to establish the previous value.
    State responsibilities for Cryptosporidium laboratory approval and 
oversight will be comparable to their certification responsibilities 
for the chemistry and microbiology laboratories that they oversee in 
their current programs (e.g., initial evaluation of laboratory 
capability; ongoing assessment of the laboratory--including an 
assessment of Proficiency Test results; and on-site audits at least 
triennially). Whereas 40 CFR 142.10(b) generally requires the 
establishment and maintenance of a laboratory ``certification'' program 
for all regulated analytes, State approval programs for Cryptosporidium 
laboratories are optional based on the structure of the LT2ESWTR (40 
CFR 141.705(a)).
    If a laboratory is located in a State that does not operate a 
Cryptosporidium laboratory certification/accreditation program, that 
laboratory can still support LT2ESWTR monitoring if the laboratory has 
been approved by another State's laboratory certification/accreditation 
program that: (1) Has demonstrated substantial conformity to procedures 
described in Chapter 7 of ``Supplement 2 to the Fifth Edition of the 
Manual for the Certification of Laboratories Analyzing Drinking Water'' 
http://water.epa.gov/scitech/drinkingwater/labcert/index.cfm#two and 
(2) uses auditors that have passed the Technical Support Center's (TSC) 
Cryptosporidium Laboratory Certification Officers Training Course. PWSs 
should be aware that their States may establish requirements that are 
more stringent than EPA's regulations; State requirements would take 
precedence.
    Consistent with the longstanding laboratory certification program 
approach, TSC will: (1) Train State/Regional Certification Officers 
(CO) responsible for auditing Cryptosporidium laboratories; (2) provide 
written guidance to State/Regional COs; (3) provide day-to-day 
technical support to States, Regions, and laboratories; (4) review/
assist the Regional programs that oversee State certification/
accreditation programs; and (5) maintain a list of links to State Web 
sites naming certified laboratories and/or a list of certified 
laboratories on EPA's Web site.
    Further information is provided at http://water.epa.gov/lawsregs/rulesregs/sdwa/lt2/lab_home.cfm.
    Form Numbers: None.
    Respondents/affected entities: Interested States and Laboratories.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 45 labs and 20 States/Territories.
    Frequency of response: Annual.
    Total estimated burden: 5,472 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Total estimated cost: $803,774.79 (per year), includes $295,056.67 
annualized capital or operation & maintenance (O&M) costs.
    Changes in Estimates: There is an increase of 629 hours in the 
total estimated respondent burden compared with the ICR currently 
approved by OMB. Changes in burden have occurred due to inflation, re-
evaluation of hours for tasks, re-evaluation of O&M costs, improved 
demonstration of capability, and integration of laboratory oversight 
into existing State certification programs (State oversight of 
laboratories was not addressed in the currently approved burden 
estimate). The increase in the respondent universe has increased the 
overall burden costs for the respondents. As the States implement their 
certification programs, future estimates will be adjusted.

    Dated: August 29, 2013.
Ann Codrington,
Acting Director, Office of Ground Water and Drinking Water.
[FR Doc. 2013-21637 Filed 9-4-13; 8:45 am]
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