Agency Information Collection Activities: Proposed Collection;
Comment Request; Laboratory Quality Assurance Evaluation Program for
Analysis of Cryptosporidium Under the Safe Drinking Water Act, EPA ICR
Number 2067.02, OMB Control Number 2040-0246
[Federal Register: June 3, 2005 (Volume 70, Number 106)]
[Notices]
[Page 32607-32609]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn05-73]
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ENVIRONMENTAL PROTECTION AGENCY
[OW-2002-0011, FRL-7921-1]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Laboratory Quality Assurance Evaluation Program for
Analysis of Cryptosporidium Under the Safe Drinking Water Act, EPA ICR
Number 2067.02, OMB Control Number 2040-0246
AGENCY: Environmental Protection Agency.
ACTION: Notice.
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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that EPA is planning to submit a
continuing Information Collection Request (ICR) to the Office of
Management and Budget (OMB). This is a request to renew an existing
approved collection. This ICR is scheduled to expire on October 31,
2005. 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 August 2, 2005.
ADDRESSES: Submit your comments, referencing docket ID number OW-2002-
0011, to EPA online using EDOCKET (our preferred method), by e-mail to
ow-docket@epamail.epa.gov, or by mail to: EPA Docket Center,
Environmental Protection Agency, W-01-17 Comment Clerk, Water Docket
(MC-4101), EPA, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: Sean Conley, Environmental Protection
Agency, Mail Stop 4607M, 1200 Pennsylvania Ave., NW., Washington, DC
20460; telephone number: 202-564-1781; fax number: 202-564-3767; e-mail
address: conley.sean@epa.gov. For technical inquiries, contact Carrie
Moulton, EPA, Office of Ground Water and Drinking Water, Technical
Support Center, 26 West Martin Luther King Drive (MS-140), Cincinnati,
Ohio 45268; fax number: (513) 569-7191; e-mail address:
moulton.carrie@epa.gov.
SUPPLEMENTARY INFORMATION: EPA has established a public docket for this
ICR under Docket ID number OW-2002-0011, which is available for public
viewing at the Water Docket Docket in the EPA Docket Center (EPA/DC),
EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m.,
[[Page 32608]]
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. An electronic version of the public
docket is available through EPA Dockets (EDOCKET) at
http://www.epa.gov/edocket. Use EDOCKET to obtain a copy of the draft
collection of information, submit or view public comments, access the
index listing of the contents of the public docket, and to access those
documents in the public docket that are available electronically. Once
in the system, select ``search,'' then key in the docket ID number
identified above.
Any comments related to this ICR should be submitted to EPA within
60 days of this notice. EPA's policy is that public comments, whether
submitted electronically or in paper, will be made available for public
viewing in EDOCKET as EPA receives them and without change, unless the
comment contains copyrighted material, confidential business
information (CBI), or other information whose public disclosure is
restricted by statute. When EPA identifies a comment containing
copyrighted material, EPA will provide a reference to that material in
the version of the comment that is placed in EDOCKET. The entire
printed comment, including the copyrighted material, will be available
in the public docket. Although identified as an item in the official
docket, information claimed as CBI, or whose disclosure is otherwise
restricted by statute, is not included in the official public docket,
and will not be available for public viewing in EDOCKET. For further
information about the electronic docket, see EPA's Federal Register
notice describing the electronic docket at 67 FR 38102 (May 31, 2002),
or go to http://www.epa.gov/edocket.
Affected entities: Entities potentially affected by this action are
public and private water testing laboratories. EPA estimates that a
total of 65 laboratories (approximately 22 laboratories per year) will
seek EPA recognition under the Laboratory QA Program.
Title: Laboratory Quality Assurance Evaluation Program for Analysis
of Cryptosporidium under the Safe Drinking Water Act.
Abstract: In September 2000, the Stage 2 Microbial and Disinfection
Byproducts Federal Advisory Committee (Committee) signed an Agreement
in Principle (Agreement) (65 FR 83015, Dec. 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 will 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 public water systems (PWSs)
would be based on the source water Cryptosporidium levels. EPA took
into account the Committee's recommendations as it developed the
proposed LT2ESWTR, which was published on August 11, 2003, (68 FR
47639), and is taking the recommendations into account as it develops
the final regulation.
In the LT2ESWTR proposed rule, EPA indicated that PWSs would be
required to use approved laboratories when conducting Cryptosporidium
monitoring under the LT2ESWTR. EPA also indicated that laboratories
approved to analyze Cryptosporidium samples under the rule must meet
the criteria in the Laboratory Quality Assurance Evaluation Program
(Lab QA Program) 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. Other existing
laboratory approval programs do not include Cryptosporidium analysis.
EPA initiated the Lab QA Program prior to promulgation of the final
LT2ESWTR to provide the time necessary to approve a sufficient number
of laboratories to assure adequate capacity for LT2ESWTR monitoring.
Early initiation of the Lab QA Program was also necessary to conform
with the Agreement recommendation that water systems with
``historical'' Cryptosporidium data that are equivalent to data that
will be collected under the LT2ESWTR be afforded the opportunity to use
those ``historical'' data in lieu of collecting new data under
LT2ESWTR. In the LT2ESWTR proposed rule, EPA proposed such provisions
to allow water systems to ``grandfather'' the historical data.
EPA anticipates the data generated by laboratories which meet the
evaluation criteria would be very high quality, thus increasing the
likelihood that such data would warrant consideration as acceptable
``grandfathered'' data. However, laboratory evaluation would not
guarantee that data generated will be acceptable as ``grandfathered''
data, nor would failure to meet evaluation criteria necessarily
preclude use of ``grandfathered'' data. For these reasons, EPA
established the Lab QA Program as a discretionary and voluntary program
under the Safe Drinking Water Act, section 1442 (42 U.S.C. 300j-1(a)).
Through today's notice, EPA is inviting comment on the continuation
of the Lab QA Program. Under the Lab QA Program, EPA evaluates
laboratories on a case-by-case basis through evaluating their capacity
and competency to reliably measure for the occurrence of
Cryptosporidium in surface water using EPA Method 1622 or EPA Method
1623. To obtain approval under the program, the laboratory must submit
an application package and provide a demonstration of availability of
qualified personnel and appropriate instrumentation, equipment and
supplies; a detailed laboratory standard operating procedure for each
version of the method that the laboratory will use to conduct the
Cryptosporidium analyses; a current copy of the table of contents of
their laboratory's quality assurance plan for protozoa analyses; and an
initial demonstration of capability (IDC) data for EPA Method 1622 or
EPA Method 1623, which include precision and recovery (IPR) test
results and matrix spike/matrix spike duplicate (MS/MSD) test results
for Cryptosporidium.
After the laboratory submits to EPA an application package
including supporting documentation, EPA and the laboratory conduct the
following steps to complete the process:
1. EPA contacts the laboratory for follow-up information and to
schedule participation in the performance testing program.
2. EPA sends initial proficiency testing (IPT) samples to the
laboratory (unless the laboratory has already successfully analyzed
such samples under EPA's Protozoan PE program). IPT samples packets
consist of eight spiked samples shipped to the laboratory within a
standard matrix.
3. The laboratory analyzes IPT samples and submits data to EPA.
4. EPA conducts an on-site evaluation and data audit.
5. The laboratory analyzes ongoing proficiency testing (OPT)
samples three times per year and submits the data to EPA. OPT sample
packets consist of three spiked samples shipped to the laboratory
within a standard matrix.
6. EPA contacts laboratories by letter within 60 days of their
laboratory on-site evaluation to confirm whether the laboratory has
demonstrated its capacity and competency for participation in the program.
The procedure for obtaining an application package, the criteria for
[[Page 32609]]
demonstrating capacity and competency, and other guidance to
laboratories that are interested in participating in the Lab QA
Program, are provided at http://www.epa.gov/safewater/lt2/cla_final.html.
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. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9 and 48 CFR Chapter 15.
The EPA is soliciting comments 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.
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. The annual public reporting and
record keeping burden for this collection of information is estimated
for a total of 65 respondents. For each respondent, an average of 19
hours is estimated per response, with 3.3 responses per year, for a
total of 3,980 hours at a cost of $166,393. The average cost per
response is estimated at $776 per response. The proposed frequency of
responses is three times a year for analysis and reporting of PT
samples and once every three years for the on-site evaluation. This
estimate assumes 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 costs
is $0.00. The estimated Operation and Maintenance (O&M) costs is $108,504.
Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
Dated: May 26, 2005.
Cynthia C. Dougherty,
Director, Office of Ground Water and Drinking Water.
[FR Doc. 05-11103 Filed 6-2-05; 8:45 am]
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