already been transferred to another party if those renewable fuel
volumes meet all of the following requirements.
    (i) The renewable fuel volumes can be described by a new pathway
that has been added to Table 1 to Sec.  80.1426, or approved by
petition pursuant to Sec.  80.1416, after July 1, 2010.
    (A) For new pathways that EPA approves in response to petitions
submitted pursuant to Sec.  80.1416, complete petitions must be
received by EPA by January 31, 2011.
    (B) [Reserved]
    (ii) The renewable fuel volumes can be described by a pathway that:
    (A) Is biodiesel that is made from canola oil through
transesterification using natural gas or biomass for process energy; or
    (B) EPA has determined was in use as of July 1, 2010, for the
primary purpose of producing transportation fuel, heating oil, or jet
fuel for commercial sale.
    (iii) The renewable fuel volumes were not designated or intended
for export from the 48 contiguous states plus Hawaii by the renewable
fuel producer or importer, and the producer or importer of the
renewable fuel volumes does not know or have reason to know that the
volumes were exported from the 48 contiguous states plus Hawaii.
    (2) When a new pathway is added to Table 1 to Sec.  80.1426 or
approved by petition pursuant to Sec.  80.1416, EPA will specify in its
approval action the effective date on which the new pathway becomes
valid for the generation of RINs and whether the fuel in question meets
the requirements of paragraph (g)(1)(ii) of this section.
    (i) The effective date for the pathway describing biodiesel that is
made from canola oil through transesterification using natural gas or
biomass for process energy is September 28, 2010.
    (ii) [Reserved]
    (3) Delayed RINs can only be generated to represent renewable fuel
volumes produced in the 48 contiguous states plus Hawaii or imported
into the 48 contiguous states plus Hawaii between July 1, 2010, and the
earlier of either of the following dates:
    (i) The effective date (identified pursuant to paragraph (g)(2) of
this section) of the new pathway through which the fuel in question was
produced; or
    (ii) December 31, 2011.
    (4) Delayed RINs must be generated no later than 60 days after the
effective date (identified pursuant to paragraph (g)(2) of this
section) of the pathway by which the fuel in question was produced.
    (5) A party authorized pursuant to paragraph (g)(1) of this section
to generate delayed RINs, and electing to do so, who generated RINs
pursuant to 80.1426(f)(6) for fuel produced through a pathway described
in paragraph (g)(1) of this section, and transferred those RINs with
renewable fuel volumes between July 1, 2010 and the effective date
(identified pursuant to paragraph (g)(2) of this section) of that
pathway, must retire a number of gallon-RINs prior to generating
delayed RINs.
    (i) The number of gallon-RINs retired by a party pursuant to this
paragraph must not exceed the number of gallon-RINs originally
generated by the party to represent fuel described in paragraph (g)(1)
of this section that was produced in the 48 contiguous states plus
Hawaii or imported into the 48 contiguous states plus Hawaii, and
transferred to another party, between July 1, 2010 and the earlier of
either of the following dates:
    (A) The effective date (identified pursuant to paragraph (g)(2) of
this section) of the new pathway through which the fuel in question was
produced; or
    (B) December 31, 2011.
    (ii) Retired RINs must have a D code of 6.
    (iii) Retired RINs must have a K code of 2.
    (iv) Retired RINs must have been generated in the same year as the
gallon-RINs originally generated by the party to represent fuel
described in paragraph (g)(1) of this section.
    (A) For gallon-RINs originally generated in 2010 to represent fuel
described in paragraph (g)(1) of this section, the generation year of
retired RINs shall be 2010.
    (B) For gallon-RINs originally generated in 2011 to represent fuel
described in paragraph (g)(1) of this section, the generation year of
retired RINs shall be 2011.
    (6) For parties that retire RINs pursuant to paragraph (g)(5) of
this section, the number of delayed gallon-RINs generated shall be
equal to the number of gallon-RINs retired in accordance with paragraph
(g)(5) of this section.
    (7) A party authorized pursuant to paragraph (g)(1) of this section
to generate delayed RINs, and electing to do so, who did not generate
RINs pursuant to Sec.  80.1426(f)(6) for renewable fuel produced in the
48 contiguous states plus Hawaii or imported into the 48 contiguous
states plus Hawaii between July 1, 2010 and the effective date
(identified pursuant to paragraph (g)(2) of this section) of a new
pathway for the fuel in question, may generate a number of delayed
gallon-RINs for that renewable fuel in accordance with paragraph (f) of
this section.
    (i) The standardized volume of fuel (Vs) used by a party
to determine the RIN volume (VRIN) under paragraph (f) of
this section shall be the standardized

volume of the fuel described in paragraph (g)(1)(i) of this section
that was produced in the 48 contiguous states plus Hawaii or imported
into the 48 contiguous states plus Hawaii by the party, and transferred
to another party, between July 1, 2010 and the earlier of either of the
following dates:
    (A) The effective date (identified pursuant to paragraph (g)(2) of
this section) of the new pathway through which the fuel in question was
produced; or
    (B) December 31, 2011.
    (ii) [Reserved]
    (8) The renewable fuel for which delayed RINs are generated must be
described by a pathway that satisfies the requirements of paragraph
(g)(1) of this section.
    (9) All delayed RINs generated by a renewable fuel producer or
importer must be generated within EMTS on the same date.
    (10) The generation year of delayed RINs as designated in EMTS
shall be the year that the renewable fuel volumes they represent were
either produced or imported into the 48 contiguous states plus Hawaii.
    (i) For renewable fuel volumes produced or imported in 2010, the
generation year of delayed RINs shall be 2010 and the production date
specified in EMTS shall be 07/01/2010.
    (ii) For renewable fuel volumes produced or imported in 2011, the
generation year of delayed RINs shall be 2011 and the production date
specified in EMTS shall be 01/01/2011.
    (11) Delayed RINs shall be generated as assigned RINs in EMTS with
a batch number that begins with ``DRN'', and then immediately separated
by the RIN generator.
    (12) The D code that shall be used in delayed RINs shall be the D
code which corresponds to the new pathway.
    (13) Except as provided in this paragraph (g), all other provisions
in this Subpart M that pertain to the identification of fuels for which
RINs may be generated, the generation and use of RINs, and
recordkeeping and reporting, are also applicable to delayed RINs.

0
4. Section 80.1454 is amended as follows:
0
a. By revising paragraph (g) introductory text.
0
b. By revising paragraph (g)(1).
0
c. By revising paragraph (g)(2) introductory text.

Sec.  80.1454  What are the recordkeeping requirements under the RFS
Program?

* * * * *
    (g) Aggregate compliance with renewable biomass requirement. Any
producer or RIN-generating importer of renewable fuel made from planted
crops or crop residue from existing U.S. agricultural land as defined
in Sec.  80.1401, or from planted crops or crop residue from existing
agricultural land in a country covered by a petition approved pursuant
to Sec.  80.1457, is covered by the aggregate compliance approach and
is not subject to the recordkeeping requirements for planted crops and
crop residue at Sec.  80.1454(g)(2) unless EPA publishes a finding that
the 2007 baseline amount of agricultural land in the U.S. has been
exceeded or, for the aggregate compliance approach in a foreign
country, that the withdrawal of EPA approval of the aggregate
compliance approach is warranted pursuant to Sec.  80.1457(e).
    (1) EPA will make findings concerning whether the 2007 baseline
amount of agricultural land in the U.S. or other country covered by a
petition approved pursuant to Sec.  80.1457 has been exceeded and will
publish these findings in the Federal Register by November 30 of the
year preceding the compliance period.
    (2) If EPA finds that the 2007 baseline amount of agricultural land
in the U.S. or other country covered by a petition approved pursuant to
Sec.  80.1457 has been exceeded, beginning on the first day of July of
the compliance period in question any producer or RIN-generating
importer of renewable fuel made from planted crops or crop residue in
the country for which such a finding is made must keep all the
following records:
* * * * *

0
5. Section 80.1457 is added to read as follows:

Sec.  80.1457  Petition process for aggregate compliance approach for
foreign countries.

    (a) EPA may approve a petition for application of the aggregate
compliance approach to planted crops and crop residue from existing
agricultural land in a foreign country if EPA determines that an
aggregate compliance approach will provide reasonable assurance that
planted crops and crop residue from the country in question meet the
definition of renewable biomass and will continue to meet the
definition of renewable biomass, based on the submission of credible,
reliable, and verifiable data.
    (1) As part of its evaluation, EPA will consider all of the
following:
    (i) Whether there has been a reasonable identification of the
``2007 baseline area of land,'' defined as the total amount of
cropland, pastureland, and land that is equivalent to U.S. Conservation
Reserve Program land in the country in question that was actively
managed or fallow and nonforested on December 19, 2007.
    (ii) Whether information on the total amount of cropland,
pastureland, and land that is equivalent to U.S. Conservation Reserve
Program land in the country in question for years preceding and
following calendar year 2007 shows that the 2007 baseline area of land
identified in paragraph (a)(1)(i) of this section is not likely to be
exceeded in the future.
    (iii) Whether economic considerations, legal constraints,
historical land use and agricultural practices and other factors show
that it is likely that producers of planted crops and crop residue will
continue to use agricultural land within the 2007 baseline area of land
identified in paragraph (a)(1)(i) of this section into the future, as
opposed to clearing and cultivating land not included in the 2007
baseline area of land.
    (iv) Whether there is a reliable method to evaluate on an annual
basis whether the 2007 baseline area of land identified in paragraph
(a)(1)(i) of this section is being or has been exceeded.
    (v) Whether a credible and reliable entity has been identified to
conduct data gathering and analysis, including annual identification of
the aggregate amount of cropland, pastureland, and land that is
equivalent to U.S. Conservation Reserve Program land, needed for the
annual EPA evaluation specified in Sec.  80.1454(g)(1), and whether the
data, analyses, and methodologies are publicly available.
    (2) [Reserved]
    (b) Any petition and all supporting materials submitted under
paragraph (a) of this section must be submitted both in English and its
original language (if other than English), and must include all of the
following or an explanation of why it is not needed for EPA to consider
the petition:
    (1) Maps or electronic data identifying the boundaries of the land
for which the petitioner seeks approval of an aggregate compliance
approach.
    (2) The total amount of land that is cropland, pastureland, or land
equivalent to U.S. Conservation Reserve Program land within the
geographic boundaries specified in paragraph (b)(1) of this section
that was cleared or cultivated prior to December 19, 2007 and that was
actively managed or fallow and nonforested on that date, and
    (3) Land use data that demonstrates that the land identified in
paragraph (b)(1) of this section is cropland, pastureland or land
equivalent to U.S. Conservation Reserve Program land that was cleared
or cultivated prior to December 19, 2007, and that was

actively managed or fallow and nonforested on that date, which may
include any of the following:
    (i) Satellite imagery or data.
    (ii) Aerial photography.
    (iii) Census data.
    (iv) Agricultural survey data.
    (v) Agricultural economic modeling data.
    (4) Historical land use data for the land within the geographic
boundaries specified in paragraph (b)(1) of this section to the current
year, which may include any of the following:
    (i) Satellite imagery or data.
    (ii) Aerial photography.
    (iii) Census data.
    (iv) Agricultural surveys.
    (v) Agricultural economic modeling data.
    (5) A description of any applicable laws, agricultural practices,
economic considerations, or other relevant factors that had or may have
an effect on the use of agricultural land within the geographic
boundaries specified in paragraph (b)(1) of this section, including
information regarding the efficacy and enforcement of relevant laws and
regulations.
    (6) A plan describing how the petitioner will identify a credible
and reliable entity who will, on a continuing basis, conduct data
gathering, analysis, and submittal to assist EPA in making an annual
determination of whether the criteria specified in paragraph (a) of
this section remains satisfied.
    (7) A letter, signed by a national government representative at the
ministerial level or equivalent, confirming that the petition and all
supporting data have been reviewed and verified by the ministry (or
ministries) or department(s) of the national government with primary
expertise in agricultural land use patterns, practices, data, and
statistics, that the data support a finding that planted crops and crop
residue from the specified country meet the definition of renewable
biomass and will continue to meet the definition of renewable biomass,
and that the responsible national government ministry (or ministries)
or department(s) will review and verify the data submitted on an annual
basis to facilitate EPA's annual evaluation of the 2007 baseline area
of land specified in Sec.  80.1454(g)(1) for the country in question.
    (8) Any additional information the Administrator may require.
    (c) EPA will issue a Federal Register notice informing the public
of receipt of any petition submitted pursuant to this section and will
provide a 60-day period for public comment. If EPA approves a petition
it will issue a Federal Register notice announcing its decision and
specifying an effective date for the application of the aggregate
compliance approach to planted crops and crop residue from the country.
Thereafter, the planted crops and crop residue from the country will be
covered by the aggregate compliance approach set forth in Sec.
80.1454(g), or as otherwise specified pursuant to paragraph (d) of this
section.
    (d) If EPA grants a petition to establish an aggregate compliance
approach for planted crops and crop residue from a foreign country, it
may include any conditions that EPA considers appropriate in light of
the conditions and circumstances involved.
    (e)(1) EPA may withdraw its approval of the aggregate compliance
approach for the planted crops and crop residue from the country in
question if:
    (i) EPA determines that the data submitted pursuant to the plan
described in paragraph (b)(6) of this section does not demonstrate that
the amount of cropland, pastureland and land equivalent to U.S.
Conservation Reserve Program land within the geographic boundaries
covered by the approved petition does not exceed the 2007 baseline area
of land;
    (ii) EPA determines based on other information that the criteria
specified in paragraph (a) of this section is no longer satisfied; or
    (iii) EPA determines that the data needed for its annual evaluation
has not been collected and submitted in a timely and appropriate
manner.
    (2) If EPA withdraws its approval for a given country, then
producers using planted crops or crop residue from that country will be
subject to the individual recordkeeping and reporting requirements of
Sec.  80.1454(b) through (d) in accordance with the schedule specified
in Sec.  80.1454(g).

[FR Doc. 2010-30296 Filed 12-8-10; 8:45 am]
BILLING CODE 6560-50-P


D 46 LCRMR REPORTING REQUIREMENTS: Number of Events System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Calculation of 90th Percentile Values and Reporting of Lead and Copper Monitoring Data1 25 100 Rout. / Full 2,754 1,002 251 Rout. / L. O. 2,754 1,002 251 Red. / Full 9,665 2,203 1,903 9,214 1,903 1,152 10,299 1,903 1,152 8,763 1,903 Red. / L. O. 9,665 2,203 1,903 9,214 1,903 1,152 10,299 1,903 1,152 8,763 1,903 101 500 Rout. / Full 2,525 918 230 Rout. / L. O. 2,525 918 230 Red. / Full 8,861 2,020 1,745 8,448 1,745 1,056 9,442 1,745 1,056 8,034 1,745 Red. / L. O. 8,861 2,020 1,745 8,448 1,745 1,056 9,442 1,745 1,056 8,034 1,745 501 3.3K Rout. / Full 1,744 634 159 Rout. / L. O. 1,744 634 159 Red. / Full 6,117 1,395 1,204 5,832 1,205 729 6,518 1,205 729 5,546 1,205 Red. / L. O. 6,117 1,395 1,204 5,832 1,205 729 6,518 1,205 729 5,546 1,205 3.3K 10K Rout. / Full 34 34 0 0 0 0 0 0 Rout. / L. O. 34 34 0 0 0 0 0 0 Red. / Full 399 176 1,763 257 176 1,729 257 176 1,729 257 176 Red. / L. O. 399 176 1,763 257 176 1,729 257 176 1,729 257 176 10K 50K Rout./ Full 22 22 Rout/ L. O 22 22 Red. / Full 258 114 1,140 166 114 1,118 166 114 1,118 166 114 Red. / L. O. 258 114 1,140 166 114 1,118 166 114 1,118 166 114 50K 100K Rout. / Full 125 0 0 0 0 Rout. / L. O. 125 0 0 0 0 June 1999 LCRMR REPORTING REQUIREMENTS: Number of Events System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 D 47 Red. / Full 0 172 156 0 47 156 0 47 156 0 47 Red. / L. O. 0 172 156 0 47 156 0 47 156 0 47 > 100K Rout. / Full 101 Rout. / L. O. 101 Red. / Full 0 139 126 0 39 126 0 39 126 0 39 Red. / L. O. 0 139 126 0 39 126 0 39 126 0 39 WQP Monitoring Results 25 100 2,504 3,505 4,006 4,006 4,006 4,006 4,006 4,006 4,006 4,006 4,006 101 500 2,296 3,214 3,673 3,673 3,673 3,673 3,673 3,673 3,673 3,673 3,673 501 3.3K 1,585 2,218 2,535 2,535 2,535 2,535 2,535 2,535 2,535 2,535 2,535 3.3K 50K 779 890 890 890 890 890 890 890 890 890 890 > 50K 1,128 1,128 1,128 1,128 1,128 1,128 1,128 1,128 1,128 1,128 1,128 Changes in Lead and Copper Tap Monitoring Location 25 100 8,704 1,979 1,330 5,690 1,175 711 6,360 1,175 711 6,141 1,175 101 500 7,978 2,052 1,378 5,898 1,218 737 6,593 1,218 737 5,631 1,218 501 3.3K 5,509 1,696 1,140 4,876 1,007 610 5,450 1,007 610 3,887 1,007 3.3K 50K 702 341 2,862 416 286 2,806 416 286 2,806 416 286 > 50K 226 311 282 0 86 282 0 86 282 0 86 Request for Reduced Lead and Copper Monitoring 25 100 0 0 0 0 101 500 0 0 0 0 501 3.3K 0 0 0 0 3.3K 50K 0 0 > 50K 0 0 Eliminate Sample Site Justification 25 100 8,703 2,246 1,509 6,457 1,333 807 7,218 1,333 807 6,141 1,333 101 500 7,979 2,059 1,384 5,920 1,223 740 6,617 1,223 740 5,631 1,223 501 3.3K 5,508 1,422 955 4,087 844 511 4,568 844 511 3,887 844 3.3K 50K 702 341 2,862 416 286 2,806 416 286 2,806 416 286 > 50K 226 311 282 0 86 282 0 86 282 0 86 Source Water Monitoring Results/ Recommendation 25 100 5 5 1,890 0 0 81 0 0 113 0 0 June 1999 LCRMR REPORTING REQUIREMENTS: Number of Events System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 D 48 101 500 6 6 1,671 0 0 50 0 0 166 0 0 501 3.3K 9 9 985 0 0 34 0 0 282 0 0 3.3K 50K 11 249 0 0 13 0 0 24 195 0 225 > 50K 17 174 0 4 172 0 0 171 29 13 171 Public Education Compliance Letter 25 100 2,921 1,669 1,669 1,669 1,669 1,669 1,669 1,669 1,669 1,669 1,669 101 500 2,678 1,530 1,530 1,530 1,530 1,530 1,530 1,530 1,530 1,530 1,530 501 3.3K 1,849 1,057 1,057 1,057 1,057 1,057 1,057 1,057 1,057 1,057 1,057 3.3K 50K 707 707 707 707 707 707 707 707 707 707 707 > 50K 74 74 74 74 74 74 74 74 74 74 74 Annual Lead Service Line Letter 25 100 174 232 232 232 232 232 232 232 232 232 232 101 500 159 213 213 213 213 213 213 213 213 213 213 501 3.3K 110 147 147 147 147 147 147 147 147 147 147 3.3K 50K 150 150 150 150 150 150 150 150 150 150 150 > 50K 20 20 20 20 20 20 20 20 20 20 20 Explanation of Changes in Treatment or Addition of A New Source for Systems on Reduced Monitoring 25 100 386 88 76 369 76 46 412 76 46 350 76 101 500 354 81 70 338 70 42 378 70 42 321 70 501 3.3K 244 56 48 233 48 29 261 48 29 222 48 3.3K 50K 26 12 116 17 12 114 17 12 114 17 12 > 50K 12 11 3 11 3 11 11 Monitoring Waiver Application 25 100 2,671 2,671 0 101 500 2,448 2,448 0 501 3.3K 1,690 1,690 0 3.3K 50K Not Applicable > 50K Eliminate First Draw and Customer Collected Certifications 25 100 24,837 6,409 4,306 18,427 3,806 2,303 20,597 3,806 2,303 17,526 3,806 101 500 22,770 5,876 3,948 16,895 3,489 2,111 18,884 3,489 2,111 16,068 3,489 501 3.3K 15,720 4,057 2,725 11,663 2,409 1,458 13,036 2,409 1,458 11,092 2,409 3.3K 50K 1,423 691 5,804 844 580 5,692 844 580 5,692 844 580 June 1999 LCRMR REPORTING REQUIREMENTS: Number of Events System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 D 49 > 50K 451 622 564 0 171 564 0 171 564 0 171 Demonstration of Representative Entry Points for Ground Water Systems 25 100 Models assumed to not apply to small systems 101 500 501 3.3K 3.3K 50K 240 > 50K 157 Reporting of Partial LSLR 25 100 623 829 829 829 829 829 829 829 829 829 829 101 500 908 1,208 1,208 1,208 1,208 1,208 1,208 1,208 1,208 1,208 1,208 501 3.3K 1,466 1,950 1,950 1,950 1,950 1,950 1,950 1,950 1,950 1,950 1,950 3.3K 50K 1,008 1,008 1,008 1,008 1,008 1,008 1,008 1,008 1,008 1,008 1,008 > 50K 144 144 144 144 144 144 144 144 144 144 144 LCRMR REPORTING TOTAL EVENTS 25 100 76,365 23,372 20,154 56,106 16,933 12,988 64,590 16,933 13,020 57,092 16,933 101 500 50,330 17,240 15,325 35,675 12,623 10,304 41,544 12,623 10,420 36,723 12,623 501 3.3K 36,444 13,613 11,793 26,548 9,997 8,331 30,694 9,997 8,579 26,467 9,997 3.3K 50K 15,413 6,592 16,302 13,662 5,835 15,325 14,747 5,846 15,520 13,211 6,047 > 50K 25,213 8,672 6,453 18,265 5,373 4,616 20,250 5,372 4,645 17,447 5,380 Total All Sizes 183,084 63,280 67,121 141,042 48,858 50,412 161,526 48,868 51,032 142,176 49,077 June 1999 D 50 BASELINE LCR REPORTING COSTS ALL SYSTEMS, All $ Totals in Thousands System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total Calculation of 90th Percentile Value and Reporting of Lead and Copper Monitoring Data 25 100 Routine 1.50 $ 119.9 $ 43.6 $ 10.9 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 174.4 Reduced 1.50 505.0 130.8 65.4 450.5 109.0 32.7 439.6 109.0 32.7 439.6 109.0 2,423.1 101 500 Routine 1.75 127.9 46.5 11.6 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 186.1 Reduced 1.50 463.0 119.9 60.0 413.0 99.9 30.0 403.0 99.9 30.0 403.0 99.9 2,221.6 501 3.3K Routine 2.00 100.8 36.7 9.2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 146.6 Reduced 1.50 319.6 82.8 41.4 285.1 69.0 20.7 278.2 69.0 20.7 278.2 69.0 1,533.5 3.3K 10K Routine 2.00 2.3 2.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 4.5 Reduced 1.50 25.7 10.3 84.0 17.1 10.3 82.2 17.1 10.3 82.2 17.1 10.3 366.7 10K 50K Routine 2.50 1.9 1.9 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.7 Reduced 1.75 19.3 7.7 63.2 12.9 7.7 61.9 12.9 7.7 61.9 12.9 7.7 275.9 50K 100K Routine 2.50 13.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 13.1 Reduced 1.75 0.0 9.2 9.2 0.0 0.0 9.2 0.0 0.0 9.2 0.0 0.0 36.9 > 100K Routine 3.00 12.7 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 12.7 Reduced 2.00 0.0 8.5 8.5 0.0 0.0 8.5 0.0 0.0 8.5 0.0 0.0 34.0 June 1999 BASELINE LCR REPORTING COSTS ALL SYSTEMS, All $ Totals in Thousands System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 51 WQP Monitoring Results 25 100 4.00 143.9 201.5 230.3 230.3 230.3 230.3 230.3 230.3 230.3 230.3 230.3 2,418.2 101 500 4.00 132.0 184.7 211.1 211.1 211.1 211.1 211.1 211.1 211.1 211.1 211.1 2,217.0 501 3.3K 4.00 91.1 127.5 145.8 145.8 145.8 145.8 145.8 145.8 145.8 145.8 145.8 1,530.4 3.3K 50K 4.00 52.3 59.7 59.7 59.7 59.7 59.7 59.7 59.7 59.7 59.7 59.7 649.4 > 50K 4.00 75.7 75.7 75.7 75.7 75.7 75.7 75.7 75.7 75.7 75.7 75.7 832.5 Changes in Lead and Copper Tap Monitoring Location 25 100 1.00 126.7 35.4 15.5 91.3 22.1 6.6 89.1 22.1 6.6 89.1 22.1 526.6 101 500 1.00 131.3 36.6 16.0 94.7 22.9 6.9 92.4 22.9 6.9 92.4 22.9 545.9 501 3.3K 1.00 108.6 30.3 13.3 78.3 18.9 5.7 76.4 18.9 5.7 76.4 18.9 451.3 3.3K 50K 1.00 14.6 6.4 44.8 9.1 5.5 43.9 9.1 5.5 43.9 9.1 5.5 197.7 > 50K 1.00 4.7 6.1 4.7 0.0 1.4 4.7 0.0 1.4 4.7 0.0 1.4 29.3 Request for Reduced Lead and Copper Monitoring 25 100 1.00 0.0 21.5 7.2 21.5 7.2 0.0 0.0 0.0 0.0 0.0 0.0 57.2 101 500 1.00 0.0 19.7 6.6 19.7 6.6 0.0 0.0 0.0 0.0 0.0 0.0 52.5 501 3.3K 1.00 0.0 13.6 4.5 13.6 4.5 0.0 0.0 0.0 0.0 0.0 0.0 36.2 3.3K 50K 1.00 0.0 7.4 0.0 1.9 0.0 0.0 0.0 0.0 0.0 0.0 0.0 9.3 > 50K 1.00 9.4 0.0 9.4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 18.8 Source Water Monitoring Results/ Recommendation 25 100 0.50 1.5 0.9 15.0 0.8 0.8 14.9 0.8 0.8 14.3 0.8 0.8 51.7 101 500 0.50 2.2 1.3 13.7 1.2 1.2 13.7 1.2 1.2 13.3 1.2 1.2 51.7 501 3.3K 0.50 3.8 2.2 9.5 2.1 2.1 9.4 2.1 2.1 9.1 2.1 2.1 46.6 June 1999 BASELINE LCR REPORTING COSTS ALL SYSTEMS, All $ Totals in Thousands System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 52 3.3K 50K 0.50 1.8 3.9 1.7 1.7 3.8 1.7 1.7 3.9 1.7 1.7 3.6 27.0 > 50K 0.50 0.4 1.8 0.3 0.4 0.4 0.3 0.4 1.7 0.3 0.4 1.7 7.9 Public Education Compliance Letter 25 100 1.00 42.7 24.4 24.4 24.4 24.4 24.4 24.4 24.4 24.4 24.4 24.4 286.7 101 500 1.00 39.2 22.4 22.4 22.4 22.4 22.4 22.4 22.4 22.4 22.4 22.4 262.9 501 3.3K 1.00 27.0 15.4 15.4 15.4 15.4 15.4 15.4 15.4 15.4 15.4 15.4 181.5 3.3K 50K 1.00 6.1 6.1 6.1 6.1 6.1 6.1 6.1 6.1 6.1 6.1 6.1 66.7 > 50K 1.00 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 6.9 Annual Lead Service Line Letter 25 100 0.50 1.3 1.7 1.7 1.7 1.7 1.7 1.7 1.7 1.7 1.7 1.7 18.7 101 500 0.50 1.2 1.6 1.6 1.6 1.6 1.6 1.6 1.6 1.6 1.6 1.6 17.1 501 3.3K 0.50 0.8 1.1 1.1 1.1 1.1 1.1 1.1 1.1 1.1 1.1 1.1 11.8 3.3K 50K 0.50 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 14.3 > 50K 0.50 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 1.9 BASELINE LCR REPORTING TOTAL COST 25 100 941.0 459.7 370.3 820.5 395.5 310.7 786.0 388.4 310.1 786.0 388.4 5,956.6 101 500 896.8 432.7 343.0 763.7 365.7 285.6 731.7 359.2 285.3 731.7 359.2 5,554.8 501 3.3K 651.7 309.6 240.1 541.4 256.8 198.1 519.0 252.3 197.8 519.0 252.3 3,938.0 3.3K 50K 125.2 106.9 260.7 109.8 94.4 256.8 107.9 94.5 256.8 107.9 94.2 1,615.1 > 50K 116.8 102.1 108.6 76.9 78.3 99.1 76.8 79.7 99.1 76.8 79.7 993.9 Total 2,731.4 1,411.0 1,322.8 2,312.3 1,190.8 1,150.4 2,221.4 1,174.0 1,149.2 2,221.4 1,173.8 18,058.5 June 1999 D 53 BASELINE LCR SYSTEM REPORTING REQUIREMENTS: Burden ALL SYSTEMS, Burden in hours System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total Calculation of 90th Percentile Levels and Reporting of Lead and Copper Monitoring Data 25 100 Routine 1.50 8,262 3,005 752 0 0 0 0 0 0 0 0 12,018 Reduced 1.50 34,802 9,014 4,506 31,046 7,512 2,253 30,294 7,512 2,253 30,294 7,512 166,997 101 500 Routine 1.75 8,836 3,213 803 0 0 0 0 0 0 0 0 12,852 Reduced 1.50 31,908 8,264 4,133 28,464 6,887 2,066 27,776 6,887 2,066 27,776 6,887 153,110 501 3.3K Routine 2.00 6,974 2,536 634 0 0 0 0 0 0 0 0 10,144 Reduced 1.50 22,025 5,705 2,852 19,649 4,754 1,427 19,173 4,754 1,427 19,173 4,754 105,689 3.3K 10K Routine 2.00 134 134 0 0 0 0 0 0 0 0 0 268 Reduced 1.50 1,521 609 4,965 1,013 609 4,863 1,013 609 4,863 1,013 609 21,686 10K 50K Routine 2.50 110 110 0 0 0 0 0 0 0 0 0 220 Reduced 1.75 1,145 459 3,743 763 459 3,668 763 459 3,668 763 459 16,347 50K 100K Routine 2.50 780 0 0 0 0 0 0 0 0 0 0 780 Reduced 1.75 0 546 546 0 0 546 0 0 546 0 0 2,184 > 100K Routine 3.00 756 0 0 0 0 0 0 0 0 0 0 756 Reduced 2.00 0 504 504 0 0 504 0 0 504 0 0 2,016 June 1999 BASELINE LCR SYSTEM REPORTING REQUIREMENTS: Burden ALL SYSTEMS, Burden in hours System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 54 WQP Monitoring Results 25 100 4.00 10,015 14,020 16,024 16,024 16,024 16,024 16,024 16,024 16,024 16,024 16,024 168,249 101 500 4.00 9,182 12,854 14,691 14,691 14,691 14,691 14,691 14,691 14,691 14,691 14,691 154,256 501 3.3K 4.00 6,339 8,873 10,141 10,141 10,141 10,141 10,141 10,141 10,141 10,141 10,141 106,483 3.3K 50K 4.00 3,116 3,560 3,560 3,560 3,560 3,560 3,560 3,560 3,560 3,560 3,560 38,716 > 50K 4.00 4,512 4,512 4,512 4,512 4,512 4,512 4,512 4,512 4,512 4,512 4,512 49,632 Changes in Lead and Copper Tap Monitoring Location 25 100 1.00 8,865 2,474 1,082 6,391 1,546 464 6,237 1,546 464 6,237 1,546 36,852 101 500 1.00 9,189 2,564 1,122 6,625 1,603 481 6,464 1,603 481 6,464 1,603 38,199 501 3.3K 1.00 7,597 2,120 928 5,477 1,325 397 5,344 1,325 397 5,344 1,325 31,579 3.3K 50K 1.00 877 384 2,687 548 329 2,632 548 329 2,632 548 329 11,843 > 50K 1.00 282 367 282 0 86 282 0 86 282 0 86 1,753 Request for Reduced Lead and Copper Monitoring 25 100 1.00 0 1,502 501 1,502 501 0 0 0 0 0 0 4,006 101 500 1.00 0 1,377 459 1,377 459 0 0 0 0 0 0 3,673 501 3.3K 1.00 0 951 317 951 317 0 0 0 0 0 0 2,535 3.3K 50K 1.00 0 445 0 111 0 0 0 0 0 0 0 556 > 50K 1.00 564 0 564 0 0 0 0 0 0 0 0 1,128 Source Water Monitoring Results/ Recommendation 25 100 0.50 102 59 1,002 57 57 999 57 57 959 57 57 3,459 101 500 0.50 149 86 919 83 83 916 83 83 891 83 83 3,457 501 3.3K 0.50 252 146 634 141 141 629 141 141 612 141 141 3,118 June 1999 BASELINE LCR SYSTEM REPORTING REQUIREMENTS: Burden ALL SYSTEMS, Burden in hours System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 55 3.3K 50K 0.50 103 222 98 98 217 98 98 222 98 98 210 1,559 > 50K 0.50 23 102 15 23 23 15 21 100 15 21 100 456 Public Education Compliance Letter 25 100 1.00 2,921 1,669 1,669 1,669 1,669 1,669 1,669 1,669 1,669 1,669 1,669 19,613 101 500 1.00 2,678 1,530 1,530 1,530 1,530 1,530 1,530 1,530 1,530 1,530 1,530 17,982 501 3.3K 1.00 1,849 1,056 1,056 1,056 1,056 1,056 1,056 1,056 1,056 1,056 1,056 12,413 3.3K 50K 1.00 356 356 356 356 356 356 356 356 356 356 356 3,916 > 50K 1.00 37 37 37 37 37 37 37 37 37 37 37 407 Annual Lead Service Line Letter 25 100 0.50 87 116 116 116 116 116 116 116 116 116 116 1,248 101 500 0.50 80 106 106 106 106 106 106 106 106 106 106 1,144 501 3.3K 0.50 55 73 73 73 73 73 73 73 73 73 73 790 3.3K 50K 0.50 75 75 75 75 75 75 75 75 75 75 75 825 > 50K 0.50 10 10 10 10 10 10 10 10 10 10 10 110 BASELINE LCR REPORTING TOTAL BURDEN 25 100 65,053 31,859 25,651 56,804 27,424 21,525 54,396 26,923 21,484 54,396 26,923 412,440 101 500 62,021 29,995 23,763 52,877 25,360 19,790 50,650 24,900 19,765 50,650 24,900 384,672 501 3.3K 45,089 21,460 16,635 37,488 17,808 13,724 35,929 17,491 13,707 35,929 17,491 272,750 3.3K 50K 7,437 6,354 15,484 6,523 5,604 15,252 6,412 5,610 15,252 6,412 5,598 95,935 > 50K 6,964 6,078 6,470 4,582 4,668 5,906 4,580 4,745 5,906 4,580 4,745 59,222 Total 186,564 95,745 88,003 158,275 80,864 76,196 151,968 79,669 76,113 151,968 79,657 1,225,020 June 1999 D 56 LCRMR REPORTING COSTS ALL SYSTEMS, All $ Totals in Thousands System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total Calculation of 90th Percentile Values and Reporting of Lead and Copper Monitoring Data 25 100 Rout. / Full 1.5 $ 59.9 $ 21.8 $ 5.5 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 87.2 Rout. / L. O. 1 40.3 14.6 3.7 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 58.6 Red. / Full 1.5 210.3 47.9 41.4 200.5 41.4 25.1 224.1 41.4 25.1 190.7 41.4 1,089.5 Red. / L. O. 1 141.3 32.2 27.8 134.7 27.8 16.8 150.6 27.8 16.8 128.1 27.8 731.8 101 500 Rout. / Full 1.75 64.0 23.3 5.8 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 93.0 Rout. / L. O. 1 36.9 13.4 3.4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 53.7 Red. / Full 1.5 192.8 44.0 38.0 183.9 38.0 23.0 205.5 38.0 23.0 174.9 38.0 998.9 Red. / L. O. 1 129.5 29.5 25.5 123.5 25.5 15.4 138.0 25.5 15.4 117.5 25.5 671.0 501 3.3K Rout. / Full 2 50.4 18.3 4.6 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 73.3 Rout. / L. O. 1 25.5 9.3 2.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 37.1 Red./ Full 1.5 133.1 30.4 26.2 126.9 26.2 15.9 141.9 26.2 15.9 120.7 26.2 689.6 Red. / L. O. 1 89.4 20.4 17.6 85.3 17.6 10.7 95.3 17.6 10.7 81.1 17.6 463.2 3.3K 10K Rout. / Full 2 1.1 1.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 2.3 Rout. / L. O. 1 0.6 0.6 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 1.1 Red./ Full 1.5 10.1 4.5 44.7 6.5 4.5 43.8 6.5 4.5 43.8 6.5 4.5 179.9 Red. / L. O. 1 6.8 3.0 30.0 4.4 3.0 29.4 4.4 3.0 29.4 4.4 3.0 120.7 10K 50K June 1999 LCRMR REPORTING COSTS ALL SYSTEMS, All $ Totals in Thousands System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 57 Rout. / Full 2.5 0.9 0.9 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 1.9 Rout. / L. O. 1 0.4 0.4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.7 Red./ Full 1.75 7.6 3.4 33.7 4.9 3.4 33.0 4.9 3.4 33.0 4.9 3.4 135.4 Red./ L. O. 1 4.4 1.9 19.4 2.8 1.9 19.0 2.8 1.9 19.0 2.8 1.9 78.0 50K 100K Rout. / Full 2.5 5.2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 5.2 Rout. / L. O. 1 2.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 2.1 Red./ Full 1.75 0.0 5.1 4.6 0.0 1.4 4.6 0.0 1.4 4.6 0.0 1.4 23.1 Red. / L. O. 1 0.0 2.9 2.7 0.0 0.8 2.7 0.0 0.8 2.7 0.0 0.8 13.3 > 100K Rout. / Full 3 5.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 5.1 Rout. / L. O. 1 1.7 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 1.7 Red. / Full 2 0.0 4.7 4.2 0.0 1.3 4.2 0.0 1.3 4.2 0.0 1.3 21.3 Red. / L. O. 1 0.0 2.4 2.1 0.0 0.7 2.1 0.0 0.7 2.1 0.0 0.7 10.8 WQP Monitoring Results 25 100 4.33 155.8 218.0 249.2 249.2 249.2 249.2 249.2 249.2 249.2 249.2 249.2 2,616.5 101 500 4.33 142.8 199.9 228.5 228.5 228.5 228.5 228.5 228.5 228.5 228.5 228.5 2,398.9 501 3.3K 4.33 98.6 138.0 157.7 157.7 157.7 157.7 157.7 157.7 157.7 157.7 157.7 1,656.0 3.3K 50K 4.33 56.6 64.6 64.6 64.6 64.6 64.6 64.6 64.6 64.6 64.6 64.6 702.7 > 50K 4.33 81.9 81.9 81.9 81.9 81.9 81.9 81.9 81.9 81.9 81.9 81.9 900.8 Changes in Lead and Copper Tap Monitoring Location 25 100 1 124.4 28.3 19.0 81.3 16.8 10.2 90.9 16.8 10.2 87.8 16.8 502.3 June 1999 LCRMR REPORTING COSTS ALL SYSTEMS, All $ Totals in Thousands System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 58 101 500 1 114.0 29.3 19.7 84.3 17.4 10.5 94.2 17.4 10.5 80.5 17.4 495.3 501 3.3K 1 78.7 24.2 16.3 69.7 14.4 8.7 77.9 14.4 8.7 55.5 14.4 383.0 3.3K 50K 1 11.7 5.7 47.8 6.9 4.8 46.8 6.9 4.8 46.8 6.9 4.8 194.0 > 50K 1 3.8 5.2 4.7 0.0 1.4 4.7 0.0 1.4 4.7 0.0 1.4 27.4 Request for Reduced Lead and Copper Monitoring 25 100 N/ A 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 101 500 N/ A 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 501 3.3K N/ A 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.3K 50K N/ A 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 > 50K N/ A 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 Eliminate Sample Site Justification 25 100 1  17.9  4.6  3.1  13.2  2.7  1.7  14.8  2.7  1.7  12.6  2.7  77.7 101 500 1  16.4  4.2  2.8  12.1  2.5  1.5  13.6  2.5  1.5  11.6  2.5  71.3 501 3.3K 1  11.3  2.9  2.0  8.4  1.7  1.0  9.4  1.7  1.0  8.0  1.7  49.2 3.3K 50K 1  1.7  0.8  7.0  1.0  0.7  6.9  1.0  0.7  6.9  1.0  0.7  28.5 > 50K 1  0.6  0.8  0.7 0.0  0.2  0.7 0.0  0.2  0.7 0.0  0.2  4.0 Source Water Monitoring Results/ Recommendation 25 100 0.5 0.0 0.0 14.1 0.0 0.0 0.6 0.0 0.0 0.8 0.0 0.0 15.7 101 500 0.5 0.0 0.0 12.5 0.0 0.0 0.4 0.0 0.0 1.2 0.0 0.0 14.2 501 3.3K 0.5 0.1 0.1 7.4 0.0 0.0 0.3 0.0 0.0 2.1 0.0 0.0 9.9 3.3K 50K 0.5 0.1 2.2 0.0 0.0 0.1 0.0 0.0 0.2 1.7 0.0 2.0 6.2 > 50K 0.5 0.1 1.5 0.0 0.0 1.5 0.0 0.0 1.5 0.3 0.1 1.5 6.5 June 1999 LCRMR REPORTING COSTS ALL SYSTEMS, All $ Totals in Thousands System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 59 Public Education Compliance Letter 25 100 1 42.7 24.4 24.4 24.4 24.4 24.4 24.4 24.4 24.4 24.4 24.4 286.7 101 500 1 39.2 22.4 22.4 22.4 22.4 22.4 22.4 22.4 22.4 22.4 22.4 262.8 501 3.3K 1 27.0 15.5 15.5 15.5 15.5 15.5 15.5 15.5 15.5 15.5 15.5 181.6 3.3K 50K 1 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 132.4 > 50K 1 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 13.9 Annual Lead Service Line Letter 25 100 0.5 1.3 1.7 1.7 1.7 1.7 1.7 1.7 1.7 1.7 1.7 1.7 18.7 101 500 0.5 1.2 1.6 1.6 1.6 1.6 1.6 1.6 1.6 1.6 1.6 1.6 17.1 501 3.3K 0.5 0.8 1.1 1.1 1.1 1.1 1.1 1.1 1.1 1.1 1.1 1.1 11.8 3.3K 50K 0.5 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 1.3 14.3 > 50K 0.5 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 1.9 Explanation of Changes in Treatment or Addition of A New Source for Systems on Reduced Monitoring 25 100 0.5 2.9 0.7 0.6 2.8 0.6 0.3 3.1 0.6 0.3 2.6 0.6 15.0 101 500 0.5 2.6 0.6 0.5 2.5 0.5 0.3 2.8 0.5 0.3 2.4 0.5 13.7 501 3.3K 0.5 1.8 0.4 0.4 1.7 0.4 0.2 1.9 0.4 0.2 1.7 0.4 9.5 3.3K 50K 0.5 0.2 0.1 1.0 0.1 0.1 1.0 0.1 0.1 1.0 0.1 0.1 4.1 > 50K 0.5 0.0 0.1 0.1 0.0 0.0 0.1 0.0 0.0 0.1 0.0 0.1 0.5 Monitoring Waiver Application 25 100 1 39.1 0.0 0.0 0.0 0.0 0.0 39.1 0.0 0.0 0.0 0.0 78.1 101 500 1 35.8 0.0 0.0 0.0 0.0 0.0 35.8 0.0 0.0 0.0 0.0 71.6 501 3.3K 1 24.7 0.0 0.0 0.0 0.0 0.0 24.7 0.0 0.0 0.0 0.0 49.4 June 1999 LCRMR REPORTING COSTS ALL SYSTEMS, All $ Totals in Thousands System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 60 3.3K 50K Not Applicable > 50K Eliminate First Draw and Customer Collected Certifications 25 100  0.1667  59.2  15.3  10.3  43.9  9.1  5.5  49.1  9.1  5.5  41.7  9.1  257.5 101 500  0.1667  54.2  14.0  9.4  40.2  8.3  5.0  45.0  8.3  5.0  38.3  8.3  236.1 501 3.3K  0.1667  37.4  9.7  6.5  27.8  5.7  3.5  31.0  5.7  3.5  26.4  5.7  163.0 3.3K 50K  0.1667  4.0  1.9  16.1  2.3  1.6  15.8  2.3  1.6  15.8  2.3  1.6  65.6 > 50K  0.1667  1.3  1.7  1.6 0.0  0.5  1.6 0.0  0.5  1.6 0.0  0.5  9.1 Demonstration of Representative Entry Points for Ground Water Systems 25 100 Assumed not to apply to small systems 101 500 501 3.3K 3.3K 50K 1 4.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 4.1 > 50K 1 2.7 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 2.7 Reporting of Partial LSLR 25 100 0.50 4.7 6.2 6.2 6.2 6.2 6.2 6.2 6.2 6.2 6.2 6.2 66.6 101 500 0.50 6.8 9.0 9.0 9.0 9.0 9.0 9.0 9.0 9.0 9.0 9.0 97.1 501 3.3K 0.50 11.0 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 156.7 3.3K 50K 0.50 8.7 8.7 8.7 8.7 8.7 8.7 8.7 8.7 8.7 8.7 8.7 96.2 > 50K 0.50 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.2 13.7 LCRMR REPORTING TOTAL COST 25 100 745.6 376.1 380.2 643.7 356.3 327.4 725.4 356.3 327.6 636.4 356.3 5,231.4 June 1999 LCRMR REPORTING COSTS ALL SYSTEMS, All $ Totals in Thousands System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 61 101 500 695.1 354.8 354.6 603.2 332.0 304.5 679.3 332.0 305.4 586.8 332.0 4,879.9 501 3.3K 492.4 259.6 255.1 436.3 239.9 220.0 490.1 239.9 221.9 413.4 239.9 3,508.7 3.3K 50K 121.0 107.7 240.1 109.0 102.1 237.1 109.0 102.2 238.8 109.0 104.0 1,579.9 > 50K 103.5 103.9 100.8 84.6 91.0 100.8 84.6 91.0 101.0 84.7 91.0 1,036.9 Total 2,157.6 1,202.1 1,330.7 1,876.8 1,121.4 1,189.8 2,088.3 1,121.5 1,194.7 1,830.3 1,123.3 16,236.7 LCRMR REPORTING BURDEN ALL SYSTEMS, Burden in hours System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total Calculation of 90th Percentile Values and Reporting of Lead and Copper Monitoring Data 25 100 Rout. / Full 1.5 4,131 1,502 376 0 0 0 0 0 0 0 0 6,009 Rout. / L. O. 1 2,754 1,002 251 0 0 0 0 0 0 0 0 4,006 Red./ Full 1.5 14,497 3,305 2,854 13,820 2,855 1,727 15,448 2,855 1,727 13,145 2,855 75,086 Red. / L. O. 1 9,665 2,203 1,903 9,214 1,903 1,152 10,299 1,903 1,152 8,763 1,903 50,057 101 500 Rout. / Full 1.75 4,418 1,607 402 0 0 0 0 0 0 0 0 6,426 Rout. / L. O. 1 2,525 918 230 0 0 0 0 0 0 0 0 3,672 Red./ Full 1.5 13,291 3,030 2,617 12,671 2,617 1,583 14,163 2,617 1,583 12,051 2,617 68,840 Red./ L. O. 1 8,861 2,020 1,745 8,448 1,745 1,056 9,442 1,745 1,056 8,034 1,745 45,893 501 3.3K June 1999 LCRMR REPORTING BURDEN ALL SYSTEMS, Burden in hours System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 62 Rout. / Full 2 3,487 1,268 317 0 0 0 0 0 0 0 0 5,072 Rout. / L. O. 1 1,744 634 159 0 0 0 0 0 0 0 0 2,536 Red./ Full 1.5 9,175 2,092 1,806 8,747 1,807 1,094 9,777 1,807 1,094 8,319 1,807 47,523 Red./ L. O. 1 6,117 1,395 1,204 5,832 1,205 729 6,518 1,205 729 5,546 1,205 31,682 3.3K 10K Rout./ Full 2 67 68 0 0 0 0 0 0 0 0 0 135 Rout./ L. O. 1 34 34 0 0 0 0 0 0 0 0 0 68 Red./ Full 1.5 598 264 2,644 385 264 2,593 385 264 2,593 385 264 10,637 Red./ L. O. 1 399 176 1,763 257 176 1,729 257 176 1,729 257 176 7,092 10K 50K Rout. / Full 2.5 55 55 0 0 0 0 0 0 0 0 0 110 Rout. / L. O. 1 22 22 0 0 0 0 0 0 0 0 0 44 Red./ Full 1.75 451 200 1,994 290 200 1,956 290 200 1,956 290 200 8,023 Red./ L. O. 1 258 114 1,140 166 114 1,118 166 114 1,118 166 114 4,585 50K 100K Rout./ Full 2.5 311 0 0 0 0 0 0 0 0 0 0 311 Rout./ L. O. 1 125 0 0 0 0 0 0 0 0 0 0 125 Red./ Full 1.75 0 301 273 0 82 273 0 82 273 0 82 1,367 Red./ L. O. 1 0 172 156 0 47 156 0 47 156 0 47 781 > 100K Rout. / Full 3 303 0 0 0 0 0 0 0 0 0 0 303 Rout. / L. O. 1 101 0 0 0 0 0 0 0 0 0 0 101 June 1999 LCRMR REPORTING BURDEN ALL SYSTEMS, Burden in hours System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 63 Red./ Full 2 0 278 252 0 77 252 0 77 252 0 77 1,265 Red./ L. O. 1 0 139 126 0 39 126 0 39 126 0 39 633 WQP Monitoring Results 25 100 4.33 10,841 15,177 17,346 17,346 17,346 17,346 17,346 17,346 17,346 17,346 17,346 182,129 101 500 4.33 9,940 13,915 15,903 15,903 15,903 15,903 15,903 15,903 15,903 15,903 15,903 166,982 501 3.3K 4.33 6,861 9,605 10,978 10,978 10,978 10,978 10,978 10,978 10,978 10,978 10,978 115,268 3.3K 50K 4.33 3,373 3,854 3,854 3,854 3,854 3,854 3,854 3,854 3,854 3,854 3,854 41,910 > 50K 4.33 4,884 4,884 4,884 4,884 4,884 4,884 4,884 4,884 4,884 4,884 4,884 53,727 Changes in Lead and Copper Tap Monitoring Location 25 100 1 8,704 1,979 1,330 5,690 1,175 711 6,360 1,175 711 6,141 1,175 35,151 101 500 1 7,978 2,052 1,378 5,898 1,218 737 6,593 1,218 737 5,631 1,218 34,658 501 3.3K 1 5,509 1,696 1,140 4,876 1,007 610 5,450 1,007 610 3,887 1,007 26,799 3.3K 50K 1 702 341 2,862 416 286 2,806 416 286 2,806 416 286 11,623 > 50K 1 226 311 282 0 86 282 0 86 282 0 86 1,641 Request for Reduced Lead and Copper Monitoring 25 100 N/ A 0 0 0 0 0 0 0 0 0 0 0 0 101 500 N/ A 0 0 0 0 0 0 0 0 0 0 0 0 501 3.3K N/ A 0 0 0 0 0 0 0 0 0 0 0 0 3.3K 50K N/ A 0 0 0 0 0 0 0 0 0 0 0 0 > 50K N/ A 0 0 0 0 0 0 0 0 0 0 0 0 Eliminate Sample Site Justification 25 100 1  1,451  374  252  1,076  222  135  1,203  222  135  1,024  222  6,315 June 1999 LCRMR REPORTING BURDEN ALL SYSTEMS, Burden in hours System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 64 101 500 1  1,330  343  231  987  204  123  1,103  204  123  938  204  5,790 501 3.3K 1  918  237  159  681  141  85  761  141  85  648  141  3,997 3.3K 50K 1  117  57  477  69  48  468  69  48  468  69  48  1,937 > 50K 1  38  52  47 0  14  47 0  14  47 0  14  274 Source Water Monitoring Results/ Recommendation 25 100 0.5 3 3 945 0 0 41 0 0 57 0 0 1,047 101 500 0.5 3 3 836 0 0 25 0 0 83 0 0 950 501 3.3K 0.5 5 5 493 0 0 17 0 0 141 0 0 660 3.3K 50K 0.5 6 125 0 0 7 0 0 12 98 0 113 359 > 50K 0.5 9 87 0 2 86 0 0 86 15 7 86 376 Public Education Compliance Letter 25 100 1 2,921 1,669 1,669 1,669 1,669 1,669 1,669 1,669 1,669 1,669 1,669 19,611 101 500 1 2,678 1,530 1,530 1,530 1,530 1,530 1,530 1,530 1,530 1,530 1,530 17,978 501 3.3K 1 1,849 1,057 1,057 1,057 1,057 1,057 1,057 1,057 1,057 1,057 1,057 12,419 3.3K 50K 1 707 707 707 707 707 707 707 707 707 707 707 7,777 > 50K 1 74 74 74 74 74 74 74 74 74 74 74 814 Annual Lead Service Line Letter 25 100 0.5 87 116 116 116 116 116 116 116 116 116 116 1,248 101 500 0.5 80 106 106 106 106 106 106 106 106 106 106 1,144 501 3.3K 0.5 55 73 73 73 73 73 73 73 73 73 73 790 3.3K 50K 0.5 75 75 75 75 75 75 75 75 75 75 75 825 > 50K 0.5 10 10 10 10 10 10 10 10 10 10 10 110 June 1999 LCRMR REPORTING BURDEN ALL SYSTEMS, Burden in hours System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 65 Explanation of Changes in Treatment or Addition of A New Source for Systems on Reduced Monitoring 25 100 0.5 193 44 38 184 38 23 206 38 23 175 38 1,001 101 500 0.5 177 40 35 169 35 21 189 35 21 161 35 918 501 3.3K 0.5 122 28 24 117 24 15 130 24 15 111 24 633 3.3K 50K 0.5 13 6 58 9 6 57 9 6 57 9 6 235 > 50K 0.5 0 6 6 0 2 6 0 2 6 0 6 31 Monitoring Waiver Application 25 100 1 2,671 0 0 0 0 0 2,670 0 0 0 0 5,341 101 500 1 2,448 0 0 0 0 0 2,448 0 0 0 0 4,896 501 3.3K 1 1,690 0 0 0 0 0 1,690 0 0 0 0 3,380 3.3K 50K Not Applicable > 50K Eliminate First Draw and Customer Collected Certifications 25 100  0.1667  4,140  1,068  718  3,071  634  384  3,433  634  384  2,921  634  18,021 101 500  0.1667  3,795  979  658  2,816  582  352  3,147  582  352  2,678  582  16,522 501 3.3K  0.1667  2,620  676  454  1,944  402  243  2,173  402  243  1,849  402  11,406 3.3K 50K  0.1667  237  115  967  141  97  949  141  97  949  141  97  3,929 > 50K  0.1667  75  104  94 0  29  94 0  29  94 0  29  546 Demonstration of Representative Entry Points for Ground Water Systems 25 100 Assumed not to apply to small systems 101 500 501 3.3K June 1999 LCRMR REPORTING BURDEN ALL SYSTEMS, Burden in hours System Size & Activities Burden per Event ( hours) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 66 3.3K 50K 1 240 0 0 0 0 0 0 0 0 0 0 240 > 50K 1 157 0 0 0 0 0 0 0 0 0 0 157 Reporting of Partial LSLR 25 100 0.50 312 415 415 415 415 415 415 415 415 415 415 4,458 101 500 0.50 454 604 604 604 604 604 604 604 604 604 604 6,494 501 3.3K 0.50 733 975 975 975 975 975 975 975 975 975 975 10,481 3.3K 50K 0.50 504 504 504 504 504 504 504 504 504 504 504 5,544 > 50K 0.50 72 72 72 72 72 72 72 72 72 72 72 792 LCRMR REPORTING TOTAL BURDEN 25 100 51,188 25,971 26,272 44,306 24,659 22,680 49,892 24,659 22,696 43,824 24,659 360,808 101 500 47,726 24,503 24,496 41,527 22,972 21,090 46,728 22,972 21,148 40,404 22,972 336,539 501 3.3K 33,808 17,914 17,612 30,030 16,583 15,219 33,715 16,583 15,343 28,450 16,583 241,840 3.3K 50K 7,147 6,372 14,155 6,451 6,047 13,981 6,451 6,053 14,078 6,451 6,153 93,339 > 50K 6,159 6,179 5,994 5,042 5,416 5,994 5,040 5,415 6,008 5,047 5,419 61,712 Total 146,027 80,938 88,528 127,355 75,678 78,964 141,826 75,683 79,274 124,175 75,788 1,094,238 June 1999 D 67 REPORTING DIFFERENCE IN COST: LCRMR minus Baseline Model ALL SYSTEMS, All $ Totals in Thousands System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total Calculation of 90th Percentile Values and Reporting of Lead and Copper Monitoring Data 25 100 Routine $ 19.7 $ 7.2 $ 1.8 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 28.6 Reduced  153.3  50.6 3.8  115.2  39.8 9.2  64.9  39.8 9.2  120.7  39.8  601.8 101 500 Routine  27.1  9.8  2.5 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  39.4 Reduced  140.6  46.4 3.5  105.7  36.4 8.4  59.5  36.4 8.4  110.7  36.4  551.8 501 3.3K Routine  24.9  9.1  2.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  36.2 Reduced  97.0  32.0 2.4  72.9  25.1 5.8  41.0  25.1 5.8  76.4  25.1  380.8 3.3K 10K Routine  0.6  0.5 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  1.1 Reduced  8.8  2.8  9.3  6.2  2.8  9.0  6.2  2.8  9.0  6.2  2.8  66.1 10K 50K Routine  0.6  0.6 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  1.1 Reduced  7.3  2.4  10.1  5.2  2.4  9.9  5.2  2.4  9.9  5.2  2.4  62.5 50K 100K Routine  5.8 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  5.8 Reduced 0.0  1.2  2.0 0.0 2.2  2.0 0.0 2.2  2.0 0.0 2.2  0.5 > 100K Routine  5.9 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  5.9 June 1999 REPORTING DIFFERENCE IN COST: LCRMR minus Baseline Model ALL SYSTEMS, All $ Totals in Thousands System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 68 Reduced 0.0  1.4  2.1 0.0 2.0  2.1 0.0 2.0  2.1 0.0 2.0  1.9 WQP Monitoring Results 25 100 11.8 16.5 18.9 18.9 18.9 18.9 18.9 18.9 18.9 18.9 18.9 198.4 101 500 10.8 15.2 17.3 17.3 17.3 17.3 17.3 17.3 17.3 17.3 17.3 181.9 501 3.3K 7.5 10.5 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 12.0 125.5 3.3K 50K 4.3 4.9 4.9 4.9 4.9 4.9 4.9 4.9 4.9 4.9 4.9 53.3 > 50K 6.2 6.2 6.2 6.2 6.2 6.2 6.2 6.2 6.2 6.2 6.2 68.3 Changes in Lead and Copper Tap Monitoring Location 25 100  2.3  7.1 3.5  10.0  5.3 3.5 1.8  5.3 3.5  1.4  5.3  24.3 101 500  17.3  7.3 3.7  10.4  5.5 3.7 1.8  5.5 3.7  11.9  5.5  50.6 501 3.3K  29.8  6.1 3.0  8.6  4.5 3.0 1.5  4.5 3.0  20.8  4.5  68.3 3.3K 50K  2.9  0.7 2.9  2.2  0.7 2.9  2.2  0.7 2.9  2.2  0.7  3.7 > 50K  0.9  0.9 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  1.9 Eliminate Sample Site Justification 25 100  17.9  4.6  3.1  13.2  2.7  1.7  14.8  2.7  1.7  12.6  2.7  77.7 101 500  16.4  4.2  2.8  12.1  2.5  1.5  13.6  2.5  1.5  11.6  2.5  71.3 501 3.3K  11.3  2.9  2.0  8.4  1.7  1.0  9.4  1.7  1.0  8.0  1.7  49.2 3.3K 50K  1.7  0.8  7.0  1.0  0.7  6.9  1.0  0.7  6.9  1.0  0.7  28.5 > 50K  0.6  0.8  0.7 0.0  0.2  0.7 0.0  0.2  0.7 0.0  0.2  4.0 Source Water Monitoring Results/ Recommendation 25 100 0.0  21.5  7.2  21.5  7.2 0.0 0.0 0.0 0.0 0.0 0.0  57.2 June 1999 REPORTING DIFFERENCE IN COST: LCRMR minus Baseline Model ALL SYSTEMS, All $ Totals in Thousands System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 69 101 500 0.0  19.7  6.6  19.7  6.6 0.0 0.0 0.0 0.0 0.0 0.0  52.5 501 3.3K 0.0  13.6  4.5  13.6  4.5 0.0 0.0 0.0 0.0 0.0 0.0  36.2 3.3K 50K 0.0  7.4 0.0  1.9 0.0 0.0 0.0 0.0 0.0 0.0 0.0  9.3 > 50K  9.4 0.0  9.4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  18.8 Public Education Compliance Letter 25 100  1.5  0.8  0.8  0.8  0.8  14.3  0.8  0.8  13.5  0.8  0.8  36.1 101 500  2.2  1.2  1.2  1.2  1.2  13.3  1.2  1.2  12.1  1.2  1.2  37.5 501 3.3K  3.7  2.1  2.1  2.1  2.1  9.1  2.1  2.1  7.0  2.1  2.1  36.7 3.3K 50K  1.7  1.7  1.7  1.7  3.6  1.7  1.7  3.6 0.0  1.7  1.7  20.8 > 50K  0.3  0.3  0.3  0.4 1.1  0.3  0.4  0.3 0.0  0.3  0.3  1.4 Annual Lead Service Line Letter 25 100 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 101 500 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  0.1 501 3.3K 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.1 3.3K 50K 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 65.7 > 50K 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 6.9 Explanation of Changes in Treatment or Addition of A New Source for Systems on Reduced Monitoring 25 100 2.9 0.7 0.6 2.8 0.6 0.3 3.1 0.6 0.3 2.6 0.6 15.0 101 500 2.6 0.6 0.5 2.5 0.5 0.3 2.8 0.5 0.3 2.4 0.5 13.7 501 3.3K 1.8 0.4 0.4 1.7 0.4 0.2 1.9 0.4 0.2 1.7 0.4 9.5 3.3K 50K 0.2 0.1 1.0 0.1 0.1 1.0 0.1 0.1 1.0 0.1 0.1 4.1 June 1999 REPORTING DIFFERENCE IN COST: LCRMR minus Baseline Model ALL SYSTEMS, All $ Totals in Thousands System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 70 > 50K 0.0 0.1 0.1 0.0 0.0 0.1 0.0 0.0 0.1 0.0 0.1 0.5 Monitoring Waiver Application 25 100 39.1 0.0 0.0 0.0 0.0 0.0 39.0 0.0 0.0 0.0 0.0 78.1 101 500 35.8 0.0 0.0 0.0 0.0 0.0 35.8 0.0 0.0 0.0 0.0 71.6 501 3.3K 24.7 0.0 0.0 0.0 0.0 0.0 24.7 0.0 0.0 0.0 0.0 49.4 3.3K 50K Not Applicable > 50K Eliminate First Draw and Customer Collected Certifications 25 100  59.2  15.3  10.3  43.9  9.1  5.5  49.1  9.1  5.5  41.7  9.1  257.5 101 500  54.2  14.0  9.4  40.2  8.3  5.0  45.0  8.3  5.0  38.3  8.3  236.1 501 3.3K  37.4  9.7  6.5  27.8  5.7  3.5  31.0  5.7  3.5  26.4  5.7  163.0 3.3K 50K  4.0  1.9  16.1  2.3  1.6  15.8  2.3  1.6  15.8  2.3  1.6  65.6 > 50K  1.3  1.7  1.6 0.0  0.5  1.6 0.0  0.5  1.6 0.0  0.5  9.1 Demonstration of Representative Entry Points for Ground Water Systems 25 100 Assumed not to apply to small systems 101 500 501 3.3K 3.3K 50K 4.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 4.1 > 50K 2.7 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 2.7 Reporting of Partial LSLR 25 100 4.7 6.2 6.2 6.2 6.2 6.2 6.2 6.2 6.2 6.2 6.2 66.6 June 1999 REPORTING DIFFERENCE IN COST: LCRMR minus Baseline Model ALL SYSTEMS, All $ Totals in Thousands System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 71 101 500 6.8 9.0 9.0 9.0 9.0 9.0 9.0 9.0 9.0 9.0 9.0 97.1 501 3.3K 11.0 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 156.7 3.3K 50K 8.7 8.7 8.7 8.7 8.7 8.7 8.7 8.7 8.7 8.7 8.7 96.2 > 50K 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.2 13.7 LCR REPORTING TOTAL COST: LCRMR MINUS BASELINE 25 100  195.4  83.7 9.9  176.9  39.2 16.7  60.6  32.0 17.5  149.6  32.0  725.3 101 500  201.7  77.9 11.5  160.5  33.7 18.9  52.5  27.1 20.1  144.9  27.1  674.9 501 3.3K  159.2  50.0 15.0  105.1  16.9 22.0  28.9  12.4 24.1  105.5  12.4  429.3 3.3K 50K  4.2 0.8  20.7  0.8 7.8  19.7 1.1 7.8  18.1 1.1 9.7  35.3 > 50K  13.3 1.9  7.8 7.7 12.7 1.6 7.7 11.3 1.9 7.8 11.4 42.9 Total  573.9  208.9 8.0  435.5  69.4 39.4  133.1  52.5 45.6  391.1  50.4  1,821.8 June 1999 D 72 REPORTING DIFFERENCE IN BURDEN: LCRMR minus Baseline Model ALL SYSTEMS, Burden in hours System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total Calculation of 90th Percentile Values and Reporting of Lead and Copper Monitoring Data 25 100 Routine  1,377  501  125 0 0 0 0 0 0 0 0  2,003 Reduced  10,640  3,506 250  8,012  2,755 626  4,548  2,755 626  8,387  2,755  41,854 101 500 Routine  1,893  689  172 0 0 0 0 0 0 0 0  2,754 Reduced  9,757  3,214 229  7,345  2,525 573  4,171  2,525 573  7,691  2,525  38,377 501 3.3K Routine  1,744  634  159 0 0 0 0 0 0 0 0  2,536 Reduced  6,733  2,218 159  5,070  1,742 396  2,878  1,742 396  5,308  1,742  26,484 3.3K 10K Routine  34  32 0 0 0 0 0 0 0 0 0  66 Reduced  525  169  559  371  169  542  371  169  542  371  169  3,957 10K 50K Routine  33  33 0 0 0 0 0 0 0 0 0  66 Reduced  436  145  610  308  145  595  308  145  595  308  145  3,739 50K 100K Routine  344 0 0 0 0 0 0 0 0 0 0  344 Reduced 0  73  117 0 129  117 0 129  117 0 129  36 > 100K Routine  352 0 0 0 0 0 0 0 0 0 0  352 Reduced 0  87  126 0 116  126 0 116  126 0 116  119 June 1999 REPORTING DIFFERENCE IN BURDEN: LCRMR minus Baseline Model ALL SYSTEMS, Burden in hours System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 73 WQP Monitoring Results 25 100 826 1,157 1,322 1,322 1,322 1,322 1,322 1,322 1,322 1,322 1,322 13,881 101 500 758 1,060 1,212 1,212 1,212 1,212 1,212 1,212 1,212 1,212 1,212 12,726 501 3.3K 523 732 837 837 837 837 837 837 837 837 837 8,785 3.3K 50K 257 294 294 294 294 294 294 294 294 294 294 3,194 > 50K 372 372 372 372 372 372 372 372 372 372 372 4,095 Changes in Lead and Copper Tap Monitoring Location 25 100  161  495 248  701  371 247 123  371 247  96  371  1,701 101 500  1,211  512 256  727  385 256 129  385 256  833  385  3,541 501 3.3K  2,088  424 212  601  318 213 106  318 213  1,457  318  4,780 3.3K 50K  175  43 175  132  43 174  132  43 174  132  43  220 > 50K  56  56 0 0 0 0 0 0 0 0 0  112 Eliminate First Draw and Customer Collected Certifications 25 100  1,451  374  252  1,076  222  135  1,203  222  135  1,024  222  6,315 101 500  1,330  343  231  987  204  123  1,103  204  123  938  204  5,790 501 3.3K  918  237  159  681  141  85  761  141  85  648  141  3,997 3.3K 50K  117  57  477  69  48  468  69  48  468  69  48  1,937 > 50K  38  52  47 0  14  47 0  14  47 0  14  274 Source Water Monitoring Results/ Recommendation 25 100 0  1,502  501  1,502  501 0 0 0 0 0 0  4,006 101 500 0  1,377  459  1,377  459 0 0 0 0 0 0  3,673 501 3.3K 0  951  317  951  317 0 0 0 0 0 0  2,535 June 1999 REPORTING DIFFERENCE IN BURDEN: LCRMR minus Baseline Model ALL SYSTEMS, Burden in hours System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 74 3.3K 50K 0  445 0  111 0 0 0 0 0 0 0  556 > 50K  564 0  564 0 0 0 0 0 0 0 0  1,128 Public Education Compliance Letter 25 100  99  57  57  57  57  959  57  57  902  57  57  2,412 101 500  146  83  83  83  83  891  83  83  808  83  83  2,508 501 3.3K  247  141  141  141  141  612  141  141  471  141  141  2,458 3.3K 50K  98  98  98  98  210  98  98  210 0  98  98  1,200 > 50K  15  15  15  21 63  15  21  15 0  15  15  81 Annual Lead Service Line Letter 25 100 0 0 0 0 0 0 0 0 0 0 0  2 101 500 0 0 0 0 0 0 0 0 0 0 0  4 501 3.3K 0 1 1 1 1 1 1 1 1 1 1 6 3.3K 50K 351 351 351 351 351 351 351 351 351 351 351 3,861 > 50K 37 37 37 37 37 37 37 37 37 37 37 407 Explanation of Changes in Treatment or Addition of A New Source for Systems on Reduced Monitoring 25 100 193 44 38 184 38 23 206 38 23 175 38 1,001 101 500 177 40 35 169 35 21 189 35 21 161 35 918 501 3.3K 122 28 24 117 24 15 130 24 15 111 24 633 3.3K 50K 13 6 58 9 6 57 9 6 57 9 6 235 > 50K 0 6 6 0 2 6 0 2 6 0 6 31 Monitoring Waiver Application 25 100 2,671 0 0 0 0 0 2,670 0 0 0 0 5,341 June 1999 REPORTING DIFFERENCE IN BURDEN: LCRMR minus Baseline Model ALL SYSTEMS, Burden in hours System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 75 101 500 2,448 0 0 0 0 0 2,448 0 0 0 0 4,896 501 3.3K 1,690 0 0 0 0 0 1,690 0 0 0 0 3,380 3.3K 50K Not Applicable > 50K No Longer Required to Complete Certification 25 100  4,140  1,068  718  3,071  634  384  3,433  634  384  2,921  634  18,021 101 500  3,795  979  658  2,816  582  352  3,147  582  352  2,678  582  16,522 501 3.3K  2,620  676  454  1,944  402  243  2,173  402  243  1,849  402  11,406 3.3K 50K  237  115  967  141  97  949  141  97  949  141  97  3,929 > 50K  75  104  94 0  29  94 0  29  94 0  29  546 Demonstration of Representative Entry Points for Ground Water Systems 25 100 Assumed not to apply to small systems 101 500 501 3.3K 3.3K 50K 240 0 0 0 0 0 0 0 0 0 0 240 > 50K 157 0 0 0 0 0 0 0 0 0 0 157 Reporting of Partial LSLR 25 100 312 415 415 415 415 415 415 415 415 415 415 4,458 101 500 454 604 604 604 604 604 604 604 604 604 604 6,494 501 3.3K 733 975 975 975 975 975 975 975 975 975 975 10,481 3.3K 50K 504 504 504 504 504 504 504 504 504 504 504 5,544 > 50K 72 72 72 72 72 72 72 72 72 72 72 792 June 1999 REPORTING DIFFERENCE IN BURDEN: LCRMR minus Baseline Model ALL SYSTEMS, Burden in hours System Size & Activities 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Total D 76 TOTAL BURDEN REPORTING DIFFERENCE: LCRMR MINUS BASELINE 25 100  13,865  5,888 621  12,498  2,765 1,155  4,504  2,264 1,212  10,572  2,264  51,632 101 500  14,295  5,492 732  11,350  2,387 1,300  3,922  1,928 1,383  10,247  1,928  48,133 501 3.3K  11,282  3,546 977  7,459  1,224 1,496  2,215  907 1,637  7,480  907  30,910 3.3K 50K  289 18  1,329  72 443  1,271 39 443  1,173 39 556  2,596 > 50K  805 101  476 460 748 88 460 670 103 467 674 2,490 Total  40,537  14,806 526  30,919  5,185 2,769  10,142  3,986 3,161  27,793  3,869  130,781


within the range of baseline values for these parameters in several
strains of rats of this age.

870.3100

	90-Day oral toxicity (rat)	43078601 (1993)

Acceptable/supplementary

0, 20, 350, 700, or 1400 ppm

M/F: 0/0, 1.4/1.6, 24.7/29.6, 52.8/57.3, and

106.8/118.1 mg/kg/d	NOAEL = 20 ppm (1.5/2.0 mg/kg/day in males/females)

LOAEL = 350 ppm (27.3/35.4 mg/kg/day in males/females), based on
decreased body weight gain in males and increased liver weights in
females.

870.3100

	90-Day oral toxicity (mouse)	46950013 (1987)

Acceptable/non-guideline

0, 5, 15, 300, or 600 ppm M: 0, 0.7, 2.2, 43.8, or 88.7 mg/kg bw/d

F: 0, 1.0, 3.2, 70.2, or 128.2 mg/kg bw/d 	NOAEL = 15 ppm (2.2 and 3.2
mg/kg bw/day in males and females)

LOAEL = 300 ppm (43.8 and 70.2 mg/kg bw/day in males and females), based
on decreased body weight gain in both sexes and evidence of liver
effects (increased liver weight in both sexes, periacinar hepatocytic
eosinophilia in males, and single cell hepatocyte necrosis in both
sexes).

870.3150

	90-Day oral toxicity (dog)	40607719 (1986)

Acceptable/guideline

0, 20, 100, 500

0, 0.8. 4.0 and 20.0 mg/kg	NOAEL = 0.8 mg/kg/day

LOAEL = 4.0 mg/kg/day, based on increased absolute liver weight &
hepatocytomegaly.

870.3200

	21/28-Day dermal toxicity (rat)	40624306 (1988)

Acceptable/guideline

0, 50, 250, 1250 mg/kg/d 	NOAEL = 250 mg/kg/day

LOAEL 1250 mg/kg/day, based on decreased body weight gain and food
consumption (M), increased AST (males), creatinine (females),
cholesterol (both sexes).

870.3700a

	Prenatal developmental in (rat)	40607721 (1985)

Acceptable/guideline

0, 6. 12, 24, 48 mg/kg/d

	Maternal NOAEL = 6 mg/kg/day

Maternal LOAEL = 12 mg/kg/day, based on decreased BWG during dosing

Developmental NOAEL = 6 mg/kg/day

Developmental LOAEL = 12 mg/kg/day, based on increased incidence of
supernumerary ribs, malformations [hydrocephaly] at 24 & 48 mg/kg/day
and cleft palate at 48 mg/kg/day.

870.3700b

	Prenatal developmental in (rabbit)	42175401 (1991),

Acceptable/guideline

0, 2, 10, 50 mg/kg/d

	Maternal NOAEL = 10 mg/kg/day

Maternal LOAEL = 50 mg/kg/day, based on decreased body weight gain.

Developmental NOAEL. = 2 mg/kg/day

Developmental LOAEL = 10 mg/kg/day, based on increased incidence of
malformed fetuses & litters with malformed fetuses.

870.3700b

	Prenatal developmental in (rabbit)	40607720 (1986)

Acceptable/guideline

0, 2, 10, 50 mg/kg/d

	Maternal NOAEL = 10 mg/kg/day

Maternal LOAEL = 50 mg/kg/day, based on inhibited BWG during treatment.

Developmental NOAEL < 2 mg/kg/day

Developmental LOAEL = 2 mg/kg/day, based on incidence of hydrocephalus
internus.

870.3800

	Reproduction and fertility effects

(rat)	4067723 (1987)

Acceptable/guideline

0, 4, 20, 120 ppm

0, 0.4, 1.7 or 10.6 mg/kg/d

	Parental NOAEL = 20 ppm (1.7 mg/kg/day)

Parental LOAEL = 120 ppm (10.6mg/kg/day), based on liver effects.

Reproductive toxicity NOAEL = 120 ppm (10.6 mg/kg/day), although
gestation length was slightly increased and litter size were decreased,
the changes are not considered treatment-related.

Reproductive LOAEL was not determined.

870.4100b

	Chronic toxicity

(dog)	41212901 (1988)

Acceptable/guideline

0, 30, 100, and 350 ppm M/F: 0/0, 1.0/1.0, 3.2/3.2, and 12. 1/12.6
mg/kg/d)	NOAEL = 30 ppm (1.0 mg/kg/day)

LOAEL = 100 ppm (3.2 mg/kg/day), based on liver effects (P450 induction
in females and histopathology, laminar eosinophilic intrahepatocytic
bodies in males).

870.4200b

.	Carcinogenicity (mouse)

	41147201(1989)

Acceptable/guideline

0, 5, 15, 100,200 ppm M/F: 0/0.69/1.03, 1.84/2.56, 13.17/17.65, or
27.85/36.30 mg/kg/d	NOAEL = M/F: 1.8/2.6 mg/kg/day

LOAEL = M/F: 13.2/17.7 mg/kg/day, based on increased incidence of
hepatocytic single-cell necrosis; increased incidence of hepatocellular
adenomas and carcinomas

870.4300

	Combined Chronic

Toxicity/Carcinogenicity (rat)	41164701 (1988)

Acceptable/guideline

0, 20, 50 or 350 ppm

M/F: 0/0, 1.0/1.2, 2.2/2/7 and 15.6/21.8 mg/kg/d 	NOAEL = 50 ppm (2.2
mg/kg/day)

LOAEL = 350 ppm (15.6 mg/kg/day), based on decreased body weight and
increased incidence of fatty infiltration in liver (M).  Dosing was
inadequate in females.

870.5100	Bacterial Reverse

Mutation Test	40607725 (1986)

Acceptable/guideline

0, 1,5, 10, 100, 500, 1000 ug/plate w/wt rat S9 mix	Negative.

870.5100	Bacterial Reverse

Mutation Test	40624307 (1985)

Unacceptable/guideline

0, 10, 100, 250, 400, 500 or 550 ug/plate w/wt rat S9 mix	Negative.

870.5300	In Vitro Gene Mutation assay in Chinese Hamster Ovary cells
40607726 (1985)

Acceptable/guideline

0, 20, 50, 100 or 200 ug/mL w/wt S9.	Negative.

870.5375	In Vitro Mammalian Chromosomal Aberration	41757801 (1990)

Unacceptable/guideline

60.1, 100.0, 150.0 or 200 ug/mL wt S9; 45.0, 59.9, 99.9 or 150.0 w S9.
Can not be interpreted.

870.5375	In Vitro Mammalian Chromosomal Aberration	46950019 (1995)

Acceptable/guideline

0, 50, 100, 200 or 400 µg/mL without S9

0, 25, 50, 100 or 200 µg/mL with metabolic

0, 50, 100, 200 or 400 µg/mL without  S9

0, 100, 200, 400 or 800 µg/mL with metabolic activation	Negative.

870.5375	In Vitro Mammalian Chromosomal Aberration	41757701 (1988)

Unacceptable/guideline

100, 150 or 200 ug/mL wt S9; 100, 150, 200 or 250   w S9.	Positive w/wt
S9.

870.5395 	In Vivo Mammalian Cytogenetics - Erythrocyte Micronucleus
Assay in Mice	40607728 (1984)

Acceptable/guideline

0, 16.7, 55.7, 167 mg/kg

	Negative.

	Cell Transformation	40607724 (1985)

Acceptable

0, 20, 50, 100 or 200 ug//mL w/wt S9 (assumed)	Negative.

870.5450	Rodent Dominant Lethal	41961401 (1991)

Acceptable/guideline

20, 40 or 80 mg/kg/d	Negative.

870.5550	Unscheduled DNA

Synthesis in Mammalian

Cells in Culture	40607729 (1988)

Unacceptable/guideline

0.15,0.5, 1.5, 5, 15, 50, 100, 150 ug//mL 	Can’t be evaluated.

870.5550	Unscheduled DNA

Synthesis in Mammalian

Cells in Culture	40607727 (1985)

Unacceptable/guideline

0.15,0.5, 1.5, 5, 15, 50, 100, 150 ug//mL 	Can’t be evaluated.

870.7485

	Metabolism and pharmacokinetics

(rat)

	41701901 (1987)

Acceptable/guideline

oral - 10mg/kg , 910 mg/kg x

14 days;

iv - 10 and 130 mg/kg

	Absorption, distribution, excretion and blood kinetics were examined.
Almost completely absorbed in males (84%) and females (106%),
extensively metabolized; diastereomers A & B of parent + 13 metabolites
identified & isolated; 35 metabolites detected; metabolic profiles for
urine, feces, bile similar; major metabolic reactions include oxidative
elimination of triazole ring; hydroxylation of C bearing CH3 group;
oxidation of CH3 group to carbinol & further to oxidation carboxylic
acid; rapid excretion with majority appearing in feces [biliary
excretion]; residual ‘4C found within renal fat, adrenals, liver;
potential liver accumulation in long-term studies.

870.7485	Metabolism and pharmacokinetics

(rat)

	46152903 (2003)

0.5 mg/kg. Animals were

dosed with the radioactive test substance daily for up to 14 days	The
majority of the total administered dose (96.5%) was recovered in the
feces (56.3%) and urine

(40.2%).

The highest blood levels were found ten days after the start of dosing
(0.08 ppm SAN 619F equivalents). Three days after the final dosing,
radioactivity was almost completely excreted. The calculated half-life
for the depletion of radioactivity (assuming mono-phasic first-order
kinetics) from the tissues ranged from one to three days. The greater
persistence and longer half-life of radioactivity in blood compared to
plasma indicated some partitioning of radioactivity into the red blood
cells. The highest concentrations of radioactivity were observed in the
liver (1.37 ppm SAN 619F equivalents), adrenals (0.93 ppm), lungs (0.56
ppm), fat (0.49 ppm), kidneys (0.25 ppm), pancreas, (0.22 ppm), and
ovaries (0.16 ppm) seven days after the start of dosing.

Urine was found to contain at least 21 metabolite fractions by
two-dimensional TLC. Individual fractions were detected in similar
proportions on Days 0-1, 6-7, and 13-14. The combined urinary metabolite
fractions accounted for 20.8-41.0% of the daily administered doses.

870.7600	Dermal penetration (rat)	43 173701 (1993),

Acceptable/guideline

0, 2.5 15 and 120 ug/cm2 for 0.5,

1,2,4 10,24 hr	At dose levels of 2.5, 15, and 120 .ig/cm2 cyproconazole,
the percent absorbed [0.87-7.69, 0.59-11.88, and 0.92-0.89,
respectively] increased with duration of exposure and decreased with
dose. The quantity absorbed increased with dose and duration of
exposure. At the 10-hour exposure time point, 10.8 1% of the low dose
was absorbed.

% absorbed = 11% for 10 hours

Cyproconazole Toxicology Executive Summaries

Reference: Memo, P. Terse, TXR No. 0053768, 11/17/2005.

1) Developmental Toxicity Study in New Zealand Rabbits	MRID 42175401

In a developmental toxicity study (MRID 42175401), cyproconazole (95%
a.i. Batch # 8507)) was administered to pregnant New Zealand White
rabbits (18/dose) in 1% aqueous methyl cellulose by gavage at dose
levels of 0, 2, 10, or 50 mg/kg bw/day from days 6 through 18 of
gestation.

Maternal toxicity as indicated by decreased body-weight gain and food
consumption was observed at the high-dose level. The pregnancy rate was
88.9% in the control, low-, and mid-dose groups and 77.8% in the
high-dose group. The number of litters with viable young was 16, 11, 14,
and 10 for the control, low-, mid-, and high-dose groups, respectively.
There was no effect noted on the numbers of implants or live fetuses per
doe, on the number of resorptions or fetal deaths, and overall mean
fetal weight and mean fetal weight/sex were comparable among the groups.
Pre- and post-implantation losses were comparable among the groups.

There was an increased incidence of total external/visceral or skeletal
malformations at the high-dose level, which was statistically
significant when compared to the concurrent control group. The incidence
in external/visceral and skeletal variations was increased in a
dose-related manner in some instances. It is concluded that the highest
dose level resulted in a slight increase in the incidence of several
malformations and variations. This is based on the facts that (1)
several of the malformations were not observed in either the concurrent
control or historical control data; (2) each of these malformations
occurred in more than one fetus and in more than one litter; (3) the
malformation, malrotated hindlimbs, was also observed at the mid-dose
but at a lower incidence than in the high-dose group (dose-related); (4)
of the twenty-three skeletal malformations observed in the study, all
but 4 were observed only at the high-dose level [one control fetus had
one malformation, one mid-dose fetus displayed 3 malformations, and one
additional mid-dose fetus displayed 1 malformation (2 different
litters)]; and (5) the mid- and high-dose fetuses displayed more
malformations/variations per fetus than the low-dose, concurrent, and
historical control groups. Also to be considered are the facts that (1)
the high-dose had the highest number of non-pregnant does and, were
these does to have been pregnant, the number of fetal findings might
have been greater for this group; and (2) both the mid- and high-dose
groups had fewer fetuses/litter than the low-dose and control groups
[5.O and 5.5 vs 6.9 and 6.4, respectively).

The maternal NOAEL was 10 mg/kg/day, the LOAEL was 50 mg/kg/day, based
on decreased body-weight gains and food consumption.

The developmental toxicity NOAEL was 2 mg/kg/day, the LOAEL was 10
mg/kg/day, based on the increased incidence of malformed fetuses and
litters with malformed fetuses.

This developmental toxicity study is classified acceptable/Guideline and
satisfy the guideline requirement for a developmental toxicity study
(OPPTS 870.3700; OECD 414) in the rabbit.

This study provided the basis for the dose and endpoint selected for
acute dietary and short- and intermediate-term dermal and inhalation
assessment.

2) Chronic Toxicity Study in Beagle Dogs		MRID 41212901

In a chronic toxicity study (MRID 41212901), cyproconazole (95% a.i.)
was administered through diet to 4 beagle dogs/sex/dose at
concentrations of 0, 30, 100 or 350 ppm [equivalent to 0, 1.0, 3.2, or
12.1 9 (males); 12.6 (females) mg/kg/day, respectively] for 52 weeks.

The results indicated liver as a target organ of toxicity.  Absolute and
relative liver weights were increased in the high dose animals of both
sexes compared to controls but statistical significance was attained
only in the males.  Elevated alkaline phosphatase and ALT levels
(males), decreased total protein, albumin and cholesterol levels were
observed in high dose animals.  Relative kidney weight was increased
significantly in both the low and high dose females but there was no
dose dependence.  Statistically significant increases were observed in
cytochrome P450 in both sexes of the high dose and in the mid dose
females.  Glutathione S-transferase (GST) values in the mid and high
dose females were significantly and dose dependently decreased.  Laminar
eosinophilic intrahepatocytic bodies were observed in all high dose
males, one mid dose male and two high dose females.

Under the conditions of this study, the LOAEL for cyproconazole in
beagle dogs is 3.2 mg/kg/day (100ppm), based on liver effects [P450
induction and GST inhibition in females and histopathology (laminar
eosinophilic intrahepatocytic bodies in male)]. The NOAEL is 1.0
mg/kg/day (30 ppm).

This chronic study in the dog is Acceptable/Guideline and satisfies the
guideline requirement for a chronic oral study [OPPTS 870.4100, OECD
452] in dog.

This study provided the basis for the dose and endpoint selected for
chronic dietary, long-term dermal and inhalation assessment.

3) Subchronic Oral Toxicity Study in Rats		MRID 46152901

In a subchronic oral toxicity study (MRID 46152901), SAN 619 A
(Cyproconazole, 95.5% a.i., Batch # Charge 8507) was administered to 15
Wistar rats/sex/dose in the diet at dose levels of 0, 20, 350, 700, or
1400 ppm (equivalent to 0/0, 1.4/1.6, 24.7/29.6, 52.8/57.3, and
106.8/118.1 mg/kg/day in males/females) for 13 weeks.  Five
rats/sex/dose were subjected to neuropathological examination, and also
evaluated in the functional observational battery, and for the
assessment of motor activity.

No treatment-related effect was observed on survival, clinical signs,
the functional observational battery, food consumption ratios, water
consumption, the eyes, gross pathology or neuropathology.

At >350 ppm, absolute and relative to body liver weights were increased
(p<0.05) by 13-55% in the both sexes.  Increased incidences of liver
fatty change in males and liver hypertrophy in both sexes were observed.
 Increased incidences of thyroid gland follicular hypertrophy were noted
in both sexes.  Pituitary gland distal lobe hypertrophy was observed in
the males.  Additionally, relative to body spleen weights were decreased
(p<0.05) in the females by 14-25%, compared to controls.

Systemically, body weights and cumulative body weight gains were
decreased (p<0.01) throughout treatment in the >700 ppm males and 1400
ppm females.  Food consumption was reduced (p<0.01) in the 1400 ppm
males during Weeks 1-7 and 11-13, and overall mean food consumption
(calculated by reviewers) was also decreased.  Motor activity was
decreased (p<0.05) in the 1400 ppm males at Week 13 in total distance,
number of movements, and movement times.

Additional effects were observed on the liver.  Increased (p<0.001)
gamma-glutamyl transpeptidase was observed in the 1400 ppm males and the
>700 ppm females.  Additional differences (p<0.01) noted at 1400 ppm
included increased alanine aminotransferase and aspartate
aminotransferase in the males, decreased triglycerides in the males, and
increased cholesterol and globulin in the females.

Increased (p<0.05) leukocytes were observed in the >700 ppm groups.
Several types of leukocytes were increased in number (g/l) in the 700
and/or 1400 ppm groups, including neutrophils, lymphocytes, monocytes,
and large unstained cells.  Urinary leukocyte levels were increased
(p<0.05) in the 1400 ppm males.

In addition to the increase in relative to body spleen weight, spleen
congestion was also observed in the >700 ppm females.  Additionally, a
decreased incidence of extramedullary hematopoiesis in the spleen was
noted in the 1400 ppm group.

Increased incidences of the following microscopic lesions were also
observed: (i) fatty change in the adrenal cortex in >700 ppm males; (ii)
single cell necrosis in the adrenal gland cortex in >700 ppm females;
(iii) ceroid deposition in the adrenal gland cortex in >700 ppm females;
and (iv) renal hemosiderosis in the 1400 ppm males and >700 ppm females.

The LOAEL is 350 ppm (equivalent to 24.7/29.6 mg/kg/day in
males/females), based on increased liver weight and increased incidence
of liver hypertrophy in both sexes and increased incidence of liver
fatty change in males.  The NOAEL is 20 ppm (equivalent to 1.4/1.6
mg/kg/day in males/females).

This study is classified as acceptable/guideline and satisfies the
guideline requirements (OPPTS 870.3100a; OECD 408) for a subchronic oral
toxicity study in the rat.

This study provided the basis for the dose and endpoint selected for
short- and intermediate-term incidental oral risk assessment.

4) 21-Day Dermal Toxicity Study in New Zealand White Rabbits	MRID
43968317

In a 21-day dermal toxicity study (MRID 43968317), SAN 619 F 320 SC 412
DP Formulation (29.4% a.i.; Batch #: 6616-01) was applied as supplied to
the shaved intact skin of 5 New Zealand White rabbits/sex/dose at dose
levels of 0, 100, 300, or 1000 mg/kg bw/day (limit dose), 6 hours/day
for at least 21 consecutive days.  Dermal irritation was evaluated daily
using the Draize method.

No compound-related effects on mortality, clinical signs, body weight,
body weight gain, food consumption, organ weights, or gross pathology
were observed.

At 1000 mg/kg/day, dermal irritation characterized by slight to well
defined erythema and edema with sloughing was observed in both sexes.
Histopathological effects observed in the treated skin in both sexes
included: (i) trace to minimal diffuse acanthosis; (ii) trace to minimal
diffuse inflammatory cells in the superficial dermis; and (iii) minimal
diffuse hyperkeratosis.  The dermal effects were transient in the males
(occurring between Days 5-15) and only slight erythema was observed in
3/5 females from Day 15 to the end of the study.

The systemic LOAEL was not observed.  The systemic NOAEL is 1000
mg/kg/day (limit dose).

The dermal LOAEL was established at 1000 mg/kg/day (limit dose) based on
erythema, edema, sloughing and histopathological effects (acanthosis,
inflammatory cells infiltration, and hyperkeratosis) in both sexes. The
dermal NOAEL is 300 mg/kg/day.

This study is classified as acceptable/guideline and satisfies the
guideline requirement (OPPTS 870.3200; OECD 410) for a 21-day dermal
toxicity study in rabbits.

5) Dermal Penetration Study in Human and Rat Skin	MRID 44883301

In a non-guideline study (MRID 44883301), the penetration rate of
[14C]-cyproconazole through human and rat skin was assessed in vitro.
[14C]-Cyproconazole (>98% radiochemical purity, batch # 900919) was
mixed with SAN 1414 F 360 SL 001 BS (6.41% w/w cyproconazole, 300 g/L
didecyldimethylammonium chloride) to a final nominal radioactive
concentration of 1 μCi/18 mg, at nominal doses of 0.641, 0.01, or
0.0012 mg a.i./cm2.  The doses approximated exposure to the undiluted
commercial formulation and to the dilute aqueous spray used in the
field.  The formulated test substance was applied to excised rat skin or
human skin (1.77 cm2/sample) mounted in an in vitro dermal penetration
cell to compare the rates of dermal penetration.  Ten samples of each
type of tissue were treated and results from the first five were
reported.  The integrity of the skin was first tested using tritiated
water, and then penetration of the test formulations was measured at 0,
1, 2, 4, 6, 10, and 24 h following application to the skin samples.

The rate of penetration of [14C]-cyproconazole following dermal
application of SAN 1414 F 360 SL 001 BS was greater through rat skin
than through human skin.  The rate of penetration of the undiluted
formulation through rat skin was 12.30 μg/cm2/h, compared to 0.501
μg/cm2/h for human skin.  As the dilution factor increased, the rate of
penetration decreased, and the permeability coefficients increased.

Recovery of radioactivity from the isolated rat and human skin samples
was >90% of the applied dose for all formulations.  The amount of
radioactivity found in the receptor fluid was greater for rat skin
(32.39-72.40% of the applied dose) than for human skin (1.32-49.22% of
the applied dose), reflecting the greater permeability of rat skin
compared to human skin.  This percentage increased with increasing
dilution for both species.

For rat skin, the percentage of radioactivity recovered in the surface
wash (8.88-16.47% of the applied dose) was less than that recovered in
the skin sample (17.45-50.78% of the applied dose).  Conversely, for
human skin, the percentage of radioactivity recovered in the surface
wash (35.52-66.42% of the applied dose) was greater than that recovered
in the skin sample (22.54-27.44% of the applied dose).

This study is classified as acceptable/non-guideline.

6) In Vivo Bone Marrow Chromosome Aberration Assay	MRID 46152902

In an in vivo bone marrow chromosome aberration assay (MRID 46152902), 5
CD1 mice/sex/dose/sampling time were treated once via oral gavage (10
mL/kg) with SAN 619 A (Cyproconazole; 95.5% a.i., Batch #: CHARGE 8507)
in Arachis oil at doses of 0, 50, 100, or 200 mg/kg.  Bone marrow cells
were harvested at 16, 24, or 48 hours after treatment in the 0 and 200
mg/kg groups, and after 24 hours in the 50 and 100 mg/kg treatment
groups and the positive controls (cyclophosphamide; 64 mg/kg).

No mortalities were observed.  Signs of toxicity (hyperactivity, ataxia,
piloerection, hunched posture, and decreased body weight) were observed
at 200 mg/kg, and to a lesser degree at 100 mg/kg.  Although there was
no indication of bone marrow toxicity (decreased mitotic index), the
animals received the maximum tolerated dose (MTD).  No treatment-related
increases in the percent of aberrant cells (including or excluding gaps)
were observed at any dose or sampling time compared to concurrent
controls.  The positive control induced the appropriate response.  There
was no evidence of chromosome aberration induced over background.

This study is classified as acceptable/guideline and satisfies the
guideline requirement (OPPTS 870.5385; OECD 475) for in vivo cytogenetic
mutagenicity data.

In a rat metabolism study (MRID 46152903, 46622801), [Phenyl-U-14C]-SAN
619F (cyproconazole; Batch # ILA-117.1; 95.9% radiochemical purity) in
2/2/1 polyethylene glycol/ethanol/water (v/v) was administered to female
HanBrl:  WIST (SPF) rats by gavage at a nominal dose level of 0.5 mg/kg.
 Animals were dosed with the radioactive test substance daily for up to
14 days, and groups of four rats were killed 1, 7, 14, or 20 days after
the first administration.  The distribution of radioactivity between
tissues was determined in all subgroups.  Radioactivity in the urine,
feces, and blood was measured, and identification of metabolites in the
urine and feces was determined in the subgroup of rats killed 20 days
after the first administration.

Recovery of [Phenyl-U-14C]-SAN 619F was 97.1% of the total administered
dose seven days after administration of the last dose.  The majority of
the total administered dose (96.5%) was recovered in the feces (56.3%)
and urine (40.2%).  The cage wash accounted for 0.19%, while the
carcass/tissues retained <0.42% of the total administered dose.

Blood kinetics showed increasing residue values with ongoing
administrations, peaking at approximately 0.075 ppm SAN 619F equivalents
within eight days after the start of dosing.  The highest blood levels
were found ten days after the start of dosing (0.08 ppm SAN 619F
equivalents).  After administration of the final dose, blood residues
declined rapidly, with a depletion half-life of approximately 40 h.

During the dosing period, a steady state in terms of excretion was
reached approximately four days after the first administration.
Thereafter, the amount of daily excretion remained nearly constant until
the end of dosing, accounting for approximately 40% of the daily dose
for urine and 55% of the daily dose for feces.  Three days after the
final dosing, radioactivity was almost completely excreted.

The levels of radioactivity reached plateau levels by seven days after
the start of dosing, and decreased rapidly once dosing ceased.  The
calculated half-life for the depletion of radioactivity (assuming
mono-phasic first-order kinetics) from the tissues ranged from one to
three days.  The greater persistence and longer half-life of
radioactivity in blood compared to plasma indicated some partitioning of
radioactivity into the red blood cells.  The highest concentrations of
radioactivity were observed in the liver (1.37 ppm SAN 619F
equivalents), adrenals (0.93 ppm), lungs (0.56 ppm), fat (0.49 ppm),
kidneys (0.25 ppm), pancreas, (0.22 ppm), and ovaries (0.16 ppm) seven
days after the start of dosing.  All other tissues had concentrations of
radioactivity that were comparable to or below the concentrations in
blood throughout the time course.

Urine was found to contain at least 21 metabolite fractions by
two-dimensional TLC.  Individual fractions were detected in similar
proportions on Days 0-1, 6-7, and 13-14.  The combined urinary
metabolite fractions accounted for 20.8-41.0% of the daily administered
doses.

More than 92.5% of the radioactivity was extractable from feces,
accounting for 25.6-56.3% of the administered daily dose.  Feces were
found to contain at least 13 metabolite fractions by two-dimensional
TLC.  The combined fecal metabolite fractions accounted for 23.7-52.5%
of the administered daily dose, while non-extractable radioactivity
accounted for 1.9-3.8% of the daily dose.  Two of the fractions
(Fractions 9 and 10) were identified as unmetabolized parent, and
Fraction 6 was identified as NOA 421153 (a diol metabolite of SAN 619F).

This metabolism study in the rat is classified acceptable/guideline and
does satisfy the guideline requirement for a Tier 1 metabolism study
[OPPTS 870.7485, OPP 85-1] in rats.

In a non-guideline study (MRID 46152909.), 5 CD-1 (Crl:CD®-1 (ICR) BR)
mice/sex/dose were exposed to SAN 619 A (Cyproconazole; 97.4% a.i.; Lot
#: MU 809073) daily in the diet at concentrations of 0, 50, 100 or 200
ppm (equivalent to 0/0, 9.0/12.7, 16.7/21.5, and 24.8/29.5 mg/kg/day
[M/F], respectively) for 14 days.  An additional group of 5 mice/sex was
treated with phenobarbitone, a known potent hepatic enzyme inducer.  On
Day 15, all animals were killed and the livers of all animals were
either processed or frozen.  The hepatic 100xg supernatant, microsomal
fraction, and cytosolic fraction were obtained by standard differential
centrifugation, and protein contents, microsomal cytochrome P450
content, enzyme activities, and immunoblot analysis for isozyme-specific
cytochrome P450 expression were determined.  The purpose of this study
was to examine whether repeated administration of SAN 619 A caused
induction of enzymes in the liver and to compare induction to
phenobarbitone.

No effects of treatment were observed on mortality, clinical
observations, body weights, food consumption, gross pathology, or
carcass weight. Relative (to body) liver weights were increased (p<0.05)
in both sexes at >100 ppm.  Absolute liver weights were increased
(p<0.001) in the 200 ppm males and the >100 ppm females.  At >50 ppm, an
increased incidence of centrilobular and midzonal hepatocellular
hypertrophy in both sexes was observed with a dose-dependent increase in
severity.  In both sexes, hypertrophy was frequently associated with
centrilobular cytoplasmic vacuolation and hepatocellular necrosis.  At
200 ppm, an increase in the incidence of mitotic activity was observed.
These liver weight and histopathological changes were similar to those
observed in phenobarbitone-treated animals.

ed mice.  Oxidation at all positions, except the 1α position in males,
contributed to this increase.  The expression of CYP 1A2, CYP 3A, and
two protein bands for CYP 2B, as determined by immunoblot analysis, was
increased in both sexes of SAN 619 A-treated mice at >50 ppm.  In
females, expression of one of two protein bands for CYP 4A was slightly
decreased at (100 ppm.

with 200 ppm SAN 619 A.  However, oxidation at the 16α position in
females and the 6α position in both sexes was more potent, and
conversion to androstenedione in both sexes was less potent when
compared to SAN 619 A-treated mice.  The expression of CYP 1A2 in
phenobarbitone-treated females, was considerably higher in than that
observed at 200 ppm in SAN 619 A-treated mice.  Additionally, decreased
expression of both protein bands identified by the antibody for CYP 4A
were observed in both sexes of phenobarbitone-treated mice, but not SAN
619 A-treated mice.

In summary, these results demonstrate an increase in isozyme-specific
cytochrome P450 activities (CYP 2B, CYP 2D, and CYP 3A families, CYP
2A4/5, and CYP 2A12 in both sexes and CYP 1A1/2, 2E1, and 4A in females)
and expression (CYP 1A2, CYP 3A, and CYP 2B), and increased phase II
enzyme activities (EH and GST in both sexes and lauric acid 11- and
12-hydroxylation in females).

The submitted study is classified as acceptable/non-guideline.

7) 13-Week feeding Study in Beagle Dogs	MRID 40607719

In a 13 Week feeding study (MRID 40607719), cyproconazole (95.6% a.i.)
was administered through diet to 4 beagle dogs/sex/dose at
concentrations of 0, 20, 100 or 500 ppm (approximately  0, 0.8, 4.0, or
20 mg/kg/day) for 13 weeks.

Changes associated with treatment observed in both sexes administered
the highest dietary level, included “slack muscle tone”, inhibited
body weight gain, increased platelet counts, decreased: bilirubin, total
cholesterol, HDL-cholesterol, triglycerides, total protein and albumin
and increased alkaline phosphatase and gamma glutamyl transferase.
Decreased food consumption was seen in high dose males.  Increased
absolute and relative liver weights and increased relative kidney
weights were noted for high dose males and females; relative brain
weights were increased in high dose females.  Histopathologic evidence
of liver toxicity in high dose males and females included
hepatocytomegaly, degeneration of single hepatocytes and cytoplasmic
inclusions.  Evidence of liver effects in mid dose dogs was increased
absolute liver weights in males and hepatocytomegaly in males and
females. However, these effects were considered adaptive changes.

Under the conditions of this study, the LOAEL for cyproconazole in
beagle dogs is 20.0  mg/kg/day (500 ppm), based on “slack muscle
tone”, inhibited body weight gain, liver effects (increased alkaline
phosphatase and gamma glutamyl transferase) and histopathologic
evidences (hepatocytomegaly, degeneration of single hepatocytes and
cytoplasmic inclusions). The NOAEL is 4.0 mg/kg/day (100 ppm).

This subchronic study in the dog is Acceptable/Guideline and satisfies
the guideline requirement for a 90-day oral toxicity study (OPPTS
870.3150; OECD 409) in non-rodent.

8) Developmental Toxicity Study in Chinchilla Rabbits	MRID 40607720

In a developmental toxicity study (MRID 40607720), SAN 619F (95.6 % a.i.
Lot # 8507)) was administered to pregnant Chinchilla rabbits (16/group)
in 4% aqueous methyl cellulose by gavage at dose levels of 0, 2, 10, or
50 mg/kg bw/day from days 6 through 18 of gestation.

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50 mg/kg. However, corrected body weight changes between groups were
comparable indicating maternal changes in body weight gain could be due
to increased resorptions.

Developmental toxicity, observed at 50 mg/kg, was evident from the
decreased number of live fetuses/dam and an increased incidence of
non-ossification in certain forelimb and hindlimb digits. Evidence of
Developmental toxicity at dosages of 10 and 50 mg/kg was indicated by an
increased incidence of embryonic and fetal resorptions.

Evidence of developmental toxicity included hydrocephalus internus,
observed in 1 fetus at each dosage level, and agenesia of the left
kidney and ureter in 1 high-dose fetus. The incidence of hydrocephalus
internus was 0.85, 0.83 and 0.93 for the low-, mid- and high-dose
fetuses and 0.08 for the historical control incidence. Hydrocephaly was
also seen at 2 dosage levels in a developmental toxicity study in rats
with this test material, however, this anomaly did not occur in the
concurrent controls of either study. In the another developmental
toxicity study in New Zealand White rabbits, Hydrocephaly was not seen.

The maternal NOAEL was 10 mg/kg, the LOAEL was 50 mg/kg, based on
decreased body-weight gains and food consumption.

Developmental toxicity NOAEL was not attained; Developmental LOAEL was 2
mg/kg, based on incidence of hydrocephalus internus.

This developmental toxicity study is classified Unacceptable/Guideline
and does not satisfy the guideline requirement for a developmental
toxicity study (OPPTS 870.3700; OECD 414) in the rabbit because: 1) a
NOAEL for developmental toxicity apparently was not attained and 2) the
concentrations of test material were not within the acceptable range (±
15% of nominal concentration) for the mid- and high dose suspensions
immediately after preparation.

In a developmental toxicity study (MRID 40607721), SAN 619F (95% a.i.
Lot # 8507)) was administered to pregnant Wistar/Han rats (25/dose) in
4% aqueous methyl cellulose by gavage at dose levels of 0, 6, 12, 24 or
48 mg/kg bw/day from days 6 through 15 of gestation.

Evidence of maternal toxicity included inhibited body weight gain
(11.4%) during treatment at dosage levels of 12 mg/kg and above and
decreased body weight and food consumption among females in the 24 and
48 mg/kg dosage groups. These differences in maternal body weights could
have been influenced by treatment-related intrauterine effects (e.g.,
increased number of resorptions, decreased fetal weight). Evidence of
fetal toxicity was apparent from observed dose-related increases in the
number of litters with supernumerary ribs at dosages 12 mg/kg and above.
Developmental toxicity was apparent at 24 and 48 mg/kg from the
following observations: decreased total number of fetuses/dam, decreased
number of live fetuses/dam, increased percentage and number of fetal
resorptions, decreased body weight and incomplete ossification in
phalangeal nuclei and the absence of ossification in calcanea. There was
evidence of developmental toxicity in the 24 and 48 mg/kg groups.
Hydrocephaly was observed in 1 fetus in the 24 mg/kg and 2 fetuses in
the 48 mg/kg groups. Cleft palate was observed in 2 fetuses in the 48
mg/kg group.

The maternal NOAEL was 6 mg/kg, the LOAEL at 12 mg/kg based on decreased
body weight gain during treatment. The developmental toxicity NOAEL was
6 mg/kg, the LOAEL at 12 mg/kg based on increased incidence of
supernumerary ribs.

This developmental toxicity study is classified acceptable/Guideline and
satisfies the guideline requirement for a developmental toxicity study
(OPPTS 870.3700; OECD 414) in the rat.

9) Two-Generation Reproductive Toxicity Study in Rats		MRID 40607723

In a 2-generation reproduction study (MRID 40607723) cyproconazole
(purity, 95.6% a.i.; lot # 8507) was administered to groups of 26/sex
KFM-Wistar albino rats/dose, in the diet, at concentrations of 0, 4, 20,
or 120 ppm (F0, M/F: 0, 0.28/0.33, 1.39/1.67, 8.29/9.88 mg/kg/day,
respectively) during the pre-mating (10 wks and 12 wks, for the F0 and
F1 generation, respectively), mating, pregnancy and lactation periods.

Two of the reproductive parameters investigated in parental animals were
affected by treatment in F0 animals only: the duration of gestation at
the mid- and high doses was increased and a lower number of implantation
sites was seen in high-dose females, both in comparison to respective
concurrent control values. However, the HED/Peer Review committee (TXR #
0053466, Nov 15, 1993) concluded that the effects noted (increased
gestation length and litter size) were not treatment related.  Evidence
of liver toxicity was seen in high dose F0 males (increased lipid
storage and relative weight) and females (increased relative weight).

Parameters examined among the offspring which showed treatment-related
effects included decreased litter sizes in both the F1 and F2 high-dose
groups and the F1 mid-dose group during the early phase of lactation
(litters were standardized at day 4 post partum), decreased live birth
index in the high-dose F1 offspring and decreased viability index in the
high-dose F1 and F2 offspring. However, the HED/Peer Review committee
(TXR # 0053466, Nov 15, 1993) concluded that the effects noted (litter
size) were not treatment related.

The parental LOAEL for the systemic toxicity is 120 ppm (8.29
mg/kg/day), based on liver effects ((increased lipid storage and
relative weight).  The parental NOAEL for systemic toxicity is 20 ppm
(1.39 mg/kg/day).

The offspring toxicity NOAEL is > 120 ppm (8.29 mg/kg/day), LOAEL is not
established.

The reproductive toxicity NOAEL is > 120 ppm (8.29 mg/kg/day), LOAEL is
not established.

This study is classified Acceptable/Guideline and satisfies the
guideline requirement (It was noted that although dose levels were not
adequate, study need not be repeated since similar effects (increased
resorptions, decreased litter size) were observed in the rat
developmental study at dose levels of 24 and 48 mg/kg and a NOAEL for
these effects was established in that study.

Appendix B

Nomenclature of Triazole-related Metabolites.

Compound

Common name (Abbr)	1,2,4-Triazole (Triazole)

Chemical Name	1H-1,2,4-Triazole

CAS registry number	288-88-0

Compound

Common name (Abbr)	Triazole alanine (TA)

Chemical Name	α-amino-1H-1,2,4-triazole-1-proanoic acid

CAS registry number	114419-45-3

Compound

Common name (Abbr)	Triazole Acetic Acid (TAA)

Chemical Name	1H-1,2,4-Triazole-1-Acetic acid

CAS registry number	28711-29-7

Proposed Metabolic Profile of Cyproconazole in Laying Hens.

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