Agency Information Collection Activities: Proposed Collection; Comment Request; Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium, 32607-32609 [05-11103]
Download as PDF
Federal Register / Vol. 70, No. 106 / Friday, June 3, 2005 / Notices
31, 2002), or go to https://www.epa.gov/
edocket.
The First Federal Register dated
Wednesday, December 1, 2004,
published on page 69910 under ‘‘List of
ICRs Planned to be Submitted’’ number
(2) NESHAP for Friction Materials
Manufacturing (40 CFR part 63, subpart
OOOO), should have read NESHAP for
Friction Materials Manufacturing (40
CFR part 63, subpart QQQQQ). We are
hereby correcting the subpart to reflect
the change as QQQQQ in this Federal
Register document.
Title: NESHAP for Friction Materials
Manufacturing (Renewal).
Abstract: The National Emission
Standards for Hazardous Air Pollutants
(NESHAP), for Friction Materials
Manufacturing were proposed on
October 4, 2001 (66 FR 50768), and
promulgated on October 18, 2002 (67 FR
64498). These standards apply to any
new, reconstructed, or existing solvent
mixers located at a friction materials
manufacturing facility engaged in the
manufacture of friction materials such
as brake and clutch linings. A friction
materials manufacturing facility is only
subject to the regulation if it is a major
source of hazardous air pollutant (HAP)
if it emits or has the potential to emit
any single HAP at a rate of 10 tons (9.07
megagrams) or more per year or any
combination of HAP at a rate of 25 tons
(22.68 megagrams) or more per year.
Owners or operators must submit
notification reports upon the
construction or reconstruction of any
friction materials manufacturing facility.
Semiannual reports for periods of
operation during which the emission
limitation is exceeded (or reports
certifying that no exceedances have
occurred) also are required. Records and
reports will be required to be retained
for a total of five years: two years at the
site, and the remaining three years at an
off-site location.
Notifications are used to inform the
Agency or delegated authority when a
source becomes subject to the standard.
The reviewing authority may then
inspect the source to check if the
pollution control devices are properly
installed and operated, and the standard
is being met. The information generated
by monitoring, recordkeeping and
reporting requirements described in this
ICR is used by the Agency to ensure that
facilities that are affected by the
standard continue to operate the control
equipment and achieve continuous
compliance with the regulation.
All reports are sent to the delegated
state or local authority. In the event that
there is no such delegated authority, the
reports are sent directly to the EPA
regional office.
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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 are listed
in 40 CFR part 9 and 48 CFR chapter 15,
and are identified on the form and/or
instrument, if applicable.
Burden Statement: The annual public
reporting and recordkeeping burden for
this collection of information is
estimated to average 162 hours per
response. 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.
Respondents/Affected Entities:
Owners or operators of friction materials
manufacturing facilities.
Estimated Number of Respondents: 4.
Frequency of Response: Initially,
annually, semiannually and
occasionally.
Estimated Total Annual Hour Burden:
1,296.
Estimated Total Annual Costs:
$103,424, which includes $0 annualized
capital/startup costs, $1,000 annual
O&M costs, and $103,424 Respondent
Labor Costs.
Changes in the Estimates: There is no
change in the number of respondents
identified in the active ICR, however,
there is a decrease of 94 hours in the
estimated burden currently identified in
the OMB Inventory of Approved ICR
Burdens. The decrease is attributed to
the fact that the renewal ICR reflects
that all four sources are in compliance
with the standard and there are no new
sources with reporting requirements.
Dated: May 23, 2005.
Oscar Morales,
Director, Collection Strategies Division.
[FR Doc. 05–11102 Filed 6–2–05; 8:45 am]
BILLING CODE 6560–50–P
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32607
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
Environmental Protection
Agency.
ACTION: Notice.
AGENCY:
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 email 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; email 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.,
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32608
Federal Register / Vol. 70, No. 106 / Friday, June 3, 2005 / Notices
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
https://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 https://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
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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
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‘‘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 onsite 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
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Federal Register / Vol. 70, No. 106 / Friday, June 3, 2005 / Notices
demonstrating capacity and
competency, and other guidance to
laboratories that are interested in
participating in the Lab QA Program, are
provided at https://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
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18:03 Jun 02, 2005
Jkt 205001
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
32609
EIS No. 20050077, ERP No. D–AFS–
G65098–AR, Ozark-St. Francis
National Forests Proposed Revised
Land and Resource Management Plan,
Implementation, Several Counties,
AR.
Summary: EPA has no objections to
the proposed action.
Rating LO.
EIS No. 20050135, ERP No. DS–COE–
E39050–FL, Herbert Hoover Dike
Major Rehabilitation Evaluation
Study, Proposed to Reduce the
Probability of a Breach of Reach One,
Lake Okeechobee, Martin and Palm
Beach Counties, FL.
Summary: EPA’s previous concerns
have been resolved; therefore, EPA has
no objection to the proposed action.
Rating LO.
Final EISs
ENVIRONMENTAL PROTECTION
AGENCY
[ER–FRL–6664–1]
Environmental Impact Statements and
Regulations; Availability of EPA
Comments
Availability of EPA comments
prepared pursuant to the Environmental
Review Process (ERP), under section
309 of the Clean Air Act and Section
102(2)(c) of the National Environmental
Policy Act as amended. Requests for
copies of EPA comments can be directed
to the Office of Federal Activities at
202–564–7167. An explanation of the
ratings assigned to draft environmental
impact statements (EISs) was published
in Federal Register dated April 1, 2005
(70 FR 16815).
Draft EISs
EIS No. 20050068, ERP No. D–AFS–
G65072–00, Ouachita National Forest,
Proposed Revised Land and Resource
Management Plan, Implementation,
Several Counties, AR; and LeFlore
and McCurtain Counties, OK.
Summary: EPA has no objections to
the proposed action.
Rating LO.
EIS No. 20050076, ERP No. D–NOA–
A91071–00, Atlantic Large Whale
Take Reduction Plan, Proposed
Amendments to Implement Specific
Gear Modifications for Trap/Pot and
Gillnet Fisheries, Broad—Based Gear
Modifications, Exclusive Economic
Zone (EEZ), ME, CT and RI.
Summary: EPA has no objections to
the proposed action.
Rating LO.
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EIS No. 20050102, ERP No. F–COE–
F36166–OH, Mill Creek, Ohio Flood
Damage Reduction Project, To Reduce
Damages to Communities, Hamilton
County, OH.
Summary: EPA’s previous concerns
relating to Total Maximum Daily Load
issues were adequately addressed;
therefore, EPA has no objections to the
proposed action.
EIS No. 20050146, ERP No. F–NPS–
E65068–00, Vicksburg Campaign Trail
(VCT) Feasibility Study, To Examine
and Evaluate a Number of Sites,
Implementation, Mississippi River,
AR, LA, TN, MS and KY.
Summary: EPA has no objection to the
preferred alternative, which includes
acquiring and/or managing and
protecting nationally significant
Vicksburg Campaign battlefield sites.
EIS No. 20050088, ERP No. FC–NOA–
E91015–00, Reef Fish Fishery
Management Plan (FMP) Amendment
23, to Set Vermilion Snapper
Sustainable Fisheries Act Targets and
Thresholds and to Establish a Plan to
End Overfishing and Rebuild the
Stock, Implementation, Gulf of
Mexico.
Summary: EPA’s comments on the
Draft Supplemental EIS have been
addressed; there, EPA has no objections
to the proposed action.
Dated: May 31, 2005.
Ken Mittelholtz,
Environmental Protection Specialist, Office
of Federal Activities.
[FR Doc. 05–11109 Filed 6–2–05; 8:45 am]
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Agencies
[Federal Register Volume 70, Number 106 (Friday, June 3, 2005)]
[Notices]
[Pages 32607-32609]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11103]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://
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 https://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 https://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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