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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]
BILLING CODE 6560-50-P

 
 

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