UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

        			      OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		6 March 2008

	Subject:	Cyazofamid. PP# 7E7244:  Petition for the Establishment of a
Tolerance for the Combined Residues of Cyazofamid and its Metabolite
CCIM, in/on Carrot, Roots.  Summary of Analytical Chemistry and Residue
Data.

             DP Number :	343419

 Decision No.  	381623

PC Code:

085651	Submission:

40 CFR §180

601

MRID/PMRA No.

47186801/1460112

	From:	Amelia Acierto, Chemist

		Registration Action Branch 3

		Health Effects Division (7509P)

	Through:	Paula Deschamp, Branch Chief

		Registration Action Branch 3

		Health Effects Division (7509P)

	To:	Barbara Madden, Team Leader

		Minor Use, Inerts and Emergency Response Branch (MUIERB)

       Registration Division (7505P)

			and

		Cynthia Giles-Parker, Chief

	      Fungicide Branch

      Registration Division (7505P)

Executive Summary

The Agriculture and Agri-Food Canada (AAFC) and the Interregional
Research Project No. 4 (IR-4), Rutgers, The State University of New
Jersey on behalf of the Agricultural Experiment Stations of Florida,
California, Washington, Georgia and New York have proposed the
establishment of a tolerance for the combined residues of cyazofamid
[4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfona
mide] and its metabolite  CCIM
[4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile], expressed as
cyazofamid, in/on carrot, root at 0.06 ppm.

Permanent tolerances are currently established (40 CFR §180.601) for
the combined residues of cyazofamid and its metabolite CCIM at 0.02 ppm
in/on potato, 0.10 ppm in/on cucurbits, 0.20 ppm in/on tomato, and 1.5
ppm in/on grape, wine.

The nature of the residue in plants is adequately understood based on
previously submitted metabolism studies on grape, potato, tomato, goat
and hen as well as a confined metabolism studies using   SEQ CHAPTER \h
\r 1  [benzene-14C]cyazofamid and [imidazole-14C]cyazofamid as test
substances.  The plant and livestock metabolism studies indicated that
several of the metabolites resulting from the cyazofamid metabolism are
common to both plants and livestock.  The proposed metabolic pathways in
the plants (tomato, potato and grape) were identical.  The studies have
been reviewed and deemed acceptable by the Agency.  (D285650, A.
Acierto, 2/20/04).

In support of the current petition for a minor use of cyazofamid in/on
carrots, the AAFC and the IR-4 have submitted residue data from crop
field studies conducted during the 2004-2005 growing season in Canada at
Zone 1A (1 trial in Prince Edward Island), Zone 5 (2 trials in
Manitoba), Zone 5B (2 trials in Quebec), and in the US at field sites
located in Region 2 (1 in Georgia), Region 3 (1 in Florida), Region 5 (1
in Michigan), Region 6 (1 in Texas), Region 10 (4 in California), and
Region 11 (1 in Washington).  The formulation used in the studies is the
3.33 lb ai/gal suspension concentrate (Ranman™ 400SC, EPA Reg, No.
71512-3, registered to ISK Biosciences Corporation).  The application
parameters consisted of one pre-emergent broadcast application directly
to the soil, followed by 4 foliar applications at the seedling to the
vegetative stage with retreatment intervals (RTI) from 12 to 92 days.
The treatment rate ranged from 163 – 186 g a.i./ha/application [0.146
– 0.166 lb ai/A/application] for a total seasonal rate ranging from
853 – 905 g a.i./ha [0.799 – 0.807 lb. a.i./A].  The preharvest
interval (PHI) ranged from 14 - 16 days.  Two decline studies were
included with PHIs at 0, 7-8, 14-15, 20-21 and 28-29 days.   The field
trials were designated either as Treatment 2 or Treatment 3.
Applications of cyazofamid in Treatment 2 was followed by sprinkler
irrigation within 6 hours.  In Treatment 3, the first 2 applications
were followed by sprinkler irrigation to ensure germination, but after
the third, fourth and fifth applications, sprinkler irrigation was not
permitted until after 24 hours  This study was added to determine the
worst case situation (i.e., 24 hour delayed irrigation after the third,
fourth and fifth treatments) as recommended by HED’s ChemSAC
(2/4/2004).

In a meeting of 2/18/04, the HED MARC concluded that for risk assessment
and tolerance expression, the parent, cyazofamid and CCIM metabolite are
the residues of concern in plants (grape, potato and tomato) and
livestock.  The parent is the residue of concern in rotational crops.

Adequate enforcement methodology is available to enforce the proposed
tolerances.  Cyazofamid and the metabolite CCIM are completely recovered
(>80% recovery) using FDA’s Multi-Residue Protocol D (without
cleanup).  In addition, the petitioner has submitted the results of an
Independent Laboratory validation (ILV) for a HPLC/UV method (high
performance liquid chromatography method using an ultra violet detector)
which can be used as a single analyte confirmatory method.

An adequate data collection method, “Independent Laboratory Validation
of the Residue Method for IKF-916 and CCIM in Tomatoes”, Document
Number 013033-0, Pyxant Labs Inc, with slight modification was used to
determine the residues of cyazofamid and CCIM.  Quantitation was
achieved by liquid chromatography/mass spectrometry/mass spectrometry
(LC/MS/MS). Based on recoveries of samples fortified with cyazofamid at
the lowest level of method validation (LLMV) of 0.01 ppm, the limit of
detection (LOD) and limit of quantitation (LOQ) were calculated to be
0.002 ppm and 0.005 ppm, respectively.  Based on recoveries of samples
fortified with CCIM at the LLMV of 0.01 ppm, the LOD and LOQ were
calculated to be 0.003 ppm, and 0.009 ppm, respectively. This method is
deemed acceptable for the determination of residues of cyazofamid and
CCIM in/on carrots.

Harvested carrot samples from these field trials were stored frozen for
a maximum of 373 days prior to extraction and analysis. A freezer
storage stability study was conducted in conjunction with the residue
study to determine the stability of cyazofamid residues in the field
trial samples under frozen conditions.  Untreated control field samples
were fortified with cyazofamid (0.10 ppm) and CCIM (0.10 ppm) and stored
frozen (<-20 °C) for 374 days. Mean recoveries of 70 – 120 % (±20 %
SD) indicated that residues of cyazofamid remained stable throughout the
storage period.  Mean recoveries of 42 ± 2 % indicated that residues of

CCIM were not stable during the storage period.

Residues of cyazofamid in treated carrot field samples ranged from <
0.01 ppm to 0.045 ppm and residues of CCIM (corrected for storage
dissipation) were all < 0.02 ppm (i.e., the combined residues were 0.03
ppm to 0.065 ppm) at the target PHI of 14 days (13 – 16 days).  Two
residue decline trials indicate that the residues of cyazofamid and CCIM
did not decline with increasing PHI.

Regulatory Recommendations and Residue Chemistry Deficiencies

Pending the resolution of the deficiencies noted below, there are no
residue chemistry issues that would preclude granting the use of
cyazofamid on the requested crop.   Sufficient data are available to
support the establishment of a permanent tolerance for the combined
residues of cyazofamid and CCIM in/on carrots.

Provided the forthcoming Human Health Risk Assessment does not identify
any risks of concern, HED recommends establishment of the tolerance as
follows:

	Carrot, root …………………………………………… 0.09
ppm

860.1200 Directions for Use

1)	As no adjuvants were used in the carrot field trials, a revised
Section B is required 	to prohibit the use of adjuvants on carrots.

860.1550   Proposed Tolerances

2)	A revised Section F is required in order to propose a tolerance for
the combined residues of cyazofamid and CCIM at 0.09 ppm in/on carrot,
root.

Background

Cyazofamid, a fungicide which belongs to a novel  chemical class based
on the cyanoimidazole moiety, is a broad spectrum fungicide active
against oomycete fungi (such as Phytophthora, Plasmopara,
Pseudoperonospora, and Pythium) and Plasmodiophoromycetes
(Plasmodiospora brassicae).  It inhibits all stages of fungal
development in the life cycle of Phythophthora infestans which causes
late blight disease on potatoes and tomatoes,  and inhibits the
germination and formation of zoosporangia, germination of cytospores,
zoospore mobility and mycelial growth.  It controls downy mildew on
cucurbit vegetables and grapes.

Cyazofamid is proposed for use on carrot to control fungal diseases:
root dieback (caused by Pythium violae and P. sulcatum), cavity spot
(caused by P. ultimum) and forking (caused by P. irregulare and P.
splendens).   Permanent tolerances are established for the combined
residues of cyazofamid and CCIM in cucurbit vegetables, group 9; grape,
wine; potato; and tomato under 40 CFR §180.601.

The chemical names and structures of cyazofamid and its major
metabolite, CCIM, are shown in Table A.1., and the physicochemical
properties of the parent are summarized in Table A.2.

Table  A.1.  Chemical Names and Structures of Cyazofamid and CCIM.

cyazofamid	Chemical Structure

Common name	Cyazofamid

Company experimental name	N/A

IUPAC name	  SEQ CHAPTER \h \r 1 4-chloro-2-cyano-N,
N-dimethyl-5-p-tolylimidazole-1-sulfonamide

CAS name	  SEQ CHAPTER \h \r 1
4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfonam
ide

CAS #	120116-88-3

End-use product/(EP)	RANMAN 400SC Agricultural Fungicide

CCIM	Chemical Structure

IUPAC name	4-chloro-5-p-tolylimidazole-2-carbonitrile

CAS name

	4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile

TABLE A.2.	Physicochemical Properties of the Technical Grade Cyazofamid.

Parameter	Value	Reference

Melting point (°C)	152.7	REG2006-05

pH	4.9	e-Pesticide Manual,

13th Edition

Density at 20 °C (g/mL)	1.446

	Water solubility (at 20 °C)	pH	Solubility (mg/L)	REG2006-05

*MRID 45408907

	5

7

9	0.121

0.107

0.109

	Solvent solubility (at 21.2°C)	Solvent	Solubility (g/L)

Acetone

Ethyl acetate

Methanol

Dichloromethane

Toluene

Hexane

n-Octanol

Acetaonitrile

2-Propanol	43.1

16.19

1.74

94.82

6.0

0.03

0.04

29.446

0.43

	Vapour pressure at 25°C	<1.33 x 10-5 Pa

	Dissociation constant (pKa)	Does not dissociate in water. No pKa in the
pH range of 2-12.

	Octanol/water partition coefficient 	LogKOW = 3.2

KOW = 1.585 X 103

	UV/visible absorption spectrum	pH	Λmax (nm)

2

7

10	285

279

287

	*Reviewed by RD (Dr. Shyam Mathur D295479).

860.1200  Directions for Use

The petitioners, Agriculture and Agri-Food Canada (AAFC) and the
Interregional Research Project No. 4 (IR-4), submitted a copy of a
supplemental label for the use of Ranman( 400SC (EPA Reg. No 71512-3)
in/on carrot.  The proposed use directions are summarized in Table A.3.

Table A.3.  Summary of Directions for Use of Cyazofamid on Carrot

Application Timing, Type, Equipment	Formulation  (EPA Reg No)	Appli Rate

g a.i./ha

[lb. a.i./A]	Max. No. Appl. per season	Total Rate

g a.i./ha

[lb. a.i./A]	PHI

(days)

Use Directions & Limitations

Broadcast or band:

 Soil:

   -Pre-emergent

 Foliar:

   - 0.5 -1” seedling

   - 2-6” vegetative

   - 6” vegetative, true

      leaves

   -18-26” vegetative

RANMAN

400SC

Reg. No.

71512-3

176.5

[0.156]

5

865.2 -880

[0.77 - 0.79]

14	1) For pre-plant incorporated (broadcast or band) applications: Apply
in sufficient water to obtain adequate coverage within 3 days of
planting and mechanically incorporate into the soil or incorporate with
at least 1/4 inch of water

2) Surface applications (Broadcast or band) may be made 14 days after
plant emergence and continue on a 14-21-day schedule. Incorporate into
the soil with ½ - 1 inch of water.

3) May be applied via an overhead irrigation system using calibration
technique directions. Apply near last 2 hours of cycle.

4) For banded applications, a 6 to 8-inch band is recommended. Use
formula to calculate amount required in the band.

      1EP = End-use Product

Conclusions.      The submitted proposed use directions are adequate to
allow evaluation of the submitted residue data for carrots.   The crop
field trial data submitted with this petition reflect the use of
cyazofamid only.  As no adjuvants were used in the carrot field trials,
a revised label is required to prohibit the use of adjuvants on carrots.

860.1300  Nature of the Residue - Plants

No new plant metabolism studies were submitted with this petition.
Adequate plant metabolism studies with cyazofamid on grape, potato and
tomato were submitted in conjunction with PP# 1F06305.  In each study,
the cyazofamid test substances were radiolabeled in either the phenyl
ring ([benzene-14C]cyazofamid) or in the 4th position of the imidazole
ring ([imidazole-14C]cyazofamid).  The principal residue component
identified in whole grapes, potatoes and tomatoes was the unchanged
parent cyazofamid and the metabolite CCIM was identified at much lower
levels.  Comparison of the metabolic profile of the initial extract with
that of the stored sample demonstrates that cyazofamid changed (degraded
by ~24%) over the 6 month storage period, with a corresponding increase
in the metabolite CCIM in  potato but remained relatively unchanged for
9 – 9.5 months in tomato under frozen conditions.

The nature of the residue in plants is adequately understood for the
purposes of this petition.

860.1300 Nature of the Residue - Livestock

No new livestock metabolism studies were submitted with this petition.
Metabolism studies with goat and hen were submitted previously (PP#
1F06305, DP# 285650, A. Acierto, 2/20/2004).  The studies were conducted
on goat (MRID 45409018) and hen (MRID 45409019).  The studies have been
reviewed and deemed acceptable.  It was concluded by the HED’s MARC
that although potatoes constitute a significant feed item for cattle,
the proposed uses fall under 40 CFR § 180.6(a)(3).

As in the previous petition, there are no poultry feed items associated
with the uses of cyazofamid.

860.1340 Residue Analytical Methods

Enforcement Method:  Adequate enforcement methodology is available to
enforce the proposed tolerances.  Cyazofamid and the metabolite CCIM are
completely recovered (>80% recovery) using FDA’s Multi-Residue
Protocol D (without cleanup).  In addition, the petitioner has submitted
the results of an Independent Laboratory validation (ILV) for a HPLC/UV
method (high performance liquid chromatography method using an ultra
violet detector) which can be used as a single analyte confirmatory
method.  ((DP# 285650, 2/20/2004, A. Acierto).

Data Collection Method:  The petitioners used the analytical method,
“Independent Laboratory Validation of the Residue Method for IKF-916
and CCIM in Tomatoes”, Document Number 013033-0, Pyxant Labs Inc”,
with slight modifications.  Quantitation was by LC/MS/MS.  Briefly,
residues of cyazofamid and CCIM were extracted from 20 grams of carrot
with acetonitrile (ACN).  After filtration, the extract was transferred
to a separatory funnel, washed with hexane, cleaned up on a Nexus SPE
column, and the eluate was concentrated by using a TurboVap LV
workstation.  After reconstitution in 50:50 ACN:H2O, quantitation was
achieved by liquid chromatography/mass spectrometry/mass spectrometry
(LC/MS/MS).  With the exception of mean method validation and concurrent
recovery values of 64 ± 5 % and 64 ± 6 %, respectively, for samples
spiked with 0.010 ppm cyazofamid, acceptability of the method was
confirmed by method validation and concurrent recoveries of 70 – 120 %
(± 20 % standard deviation (SD) for both cyazofamid and CCIM.  Based on
recoveries of samples fortified with cyazofamid at the lowest level of
method validation (LLMV) of 0.01 ppm, the LOD and LOQ were calculated to
be 0.002 ppm and 0.005 ppm, respectively.  Based on recoveries of
samples fortified with CCIM at the LLMV of 0.01 ppm, the LOD and LOQ
were calculated to be 0.003 ppm, and 0.009 ppm, respectively. This
method is deemed acceptable for the determination of residues of
cyazofamid and CCIM in/on carrots.

860.1360 Multiresidue Methods

Adequate multiresidue method data for cyazofamid and its metabolites
were submitted previously in conjunction with PP# 1F06305.   Cyazofamid
and its metabolite CCIM were analyzed according to the FDA Multi-Residue
Method (MRM) Test guidelines in PAM, Volume I Appendix II (1/94).
Testing using Protocols A and B is not required because cyazofamid and
CCIM do not have an N-methylcarbamate structure and are not acid or
phenol compounds.  Using Protocol C, injections of cyazofamid and CCIM
yielded adequate responses to several of the Section 302 GLC systems.
Cyazofamid and CCIM were completely recovered (>80% recovery) using
Protocol D (without cleanup).  Cyazofamid was partially recovered
(50-80% recovery) using Protocols E and F.  CCIM was not further tested
with Protocols E and F, because <30% of CCIM was recovered from the
Florisil column cleanup tests.

Conclusions.  The Agency found that the FDA Multi-Residue Method,
Protocol D (without cleanup) met the requirement of the Residue
Chemistry Test Guideline 860.1360 to enforce tolerances for non-fatty
commodities and recommended its use as the enforcement method to enforce
the tolerances for residues of cyazofamid and CCIM in potato, tomato,
vegetable cucurbit group 9, and grapes.  The data collection method have
been reviewed previously by the Agency’s Analytical Chemistry Branch
(ACB) and concluded that the submitted method was sufficiently validated
by an independent laboratory and that the method met the OPPTS 860.1340
Residue Chemistry Test Guidelines.

860.1380 Storage Stability

Storage stability data submitted previously (PP# 1F06305, DP# 285650,
2/20/2004, A. Acierto) demonstrated that the stability of cyazofamid and
its metabolite CCIM in grape juice, raisins, potato chips, potato
granules, potato wet peel, and tomato puree yielded variable results
when stored at -25 to 0oC for up to ~3 years.  Cyazofamid was found
stable in grape fruit up to 12 months but declined by ~50% after 24
months of storage.   Metabolite CCIM was reasonably stable for up to 6
months but declined by an average of ~50% after 24 months of storage.
Cyazofamid was relatively stable in potatoes for up ~8 months but
declined by an average of 35% after 12-36 months.  CCIM was relatively
stable for ~26 months.  In tomatoes, cyazofamid and CCIM were reasonably
stable for up to ~36 months.

In the current petition, a freezer storage stability study was conducted
in conjunction with the residue study to determine the stability of
cyazofamid residues in carrots under frozen conditions.  Untreated
control field samples were fortified with cyazofamid (0.10 ppm) and CCIM
(0.10 ppm) and stored frozen (<-20 °C) for 374 days (~12.5 months).
Mean recoveries of 70 – 120 % (±20 % SD) indicated that residues of
cyazofamid remained stable throughout the storage period.  Mean
recoveries of 42 ± 2 % which indicated that residues of CCIM were not
stable during the storage period.

	Conclusion:  The storage stability data are acceptable and are
consistent with the results observed in the other plant commodities
reported in the previous petition (PP1F06305).

860.1400 Water, Fish, and Irrigated Crops

There are no proposed uses that are relevant to this guideline topic.

860.1460 Food Handling

Cyazofamid is presently not registered or proposed for use in
food-handling establishments.

860.1480 Meat, Milk, Poultry, and Eggs

No feeding studies were submitted with this petition.  In conjunction
with the previous petition (PP# 1F06305), examination of the uses of
cyazofamid on cucurbits, potatoes, tomatoes, and imported grape, wine
indicated that potato culls and processed potato waste are the only
relevant feed items which may be fed to beef and dairy cattle.  The
contribution of potato culls and processed waste to the maximum
theoretical dietary burdens (MTDB) of cyazofamid to beef and dairy
cattle were 0.108 ppm and 0.093 ppm, respectively.

Based on the inclusion of the proposed use on carrots in this petition,
and the most recent guidance from HED concerning revisions of feedstuffs
percentages in Table 1, and constructing reasonably balanced livestock
diets (RBDs), a lower dietary burden has been estimated in Table C.1.
below (E-mail, J. Stokes, 3/17/08).

Table C.1.    Livestock dietary burdens for (cyazofamid) a      (Maximum
Reasonably Balanced Diet)

	%  Diet b	Residue (ppm)

Feedstuff	Type	Tolerance ppm	% Dry Matter	Beef	Dairy	Poultry	Swine	Beef
Diary 	Poultry 	Swine

Grass /nongrass/ cereal grain,  orage/silage/hay, untreated	R	--	--	15
45	--	--	--	--	--	--

Potato, processed waste	CC	0.02	15	30	10	Nu	Nu	0.04	0.013	--	--

carrot, culls	CC	0.09	12	Nu	10	Nu	Nu	--	0.075	--	--

Corn, field, grain/other grains/grain milled byproducts) , untreated	CC
--	--	50	25	--	--	--	--	--	--

Soybean, meal/other oilseed meals or seeds, untreated	PC	--	--	5	10	--
--	--	--	--	--

Totals

100	100	--	--	0.04	0.09	--	--

a    Residue levels for beef and dairy are corrected for moisture
content and are determined by formula: tolerance / %DM  x  % in diet.
Residue levels for poultry and swine are considered “as-is” and are
determined by formula: tolerance  x   % in diet.

Two feedstuffs, i.e., processed potato waste and carrot culls, can
contribute to estimate a maximum reasonably balanced diet.   Feedlot
beef will be fed processed potato waste (Note:  Cull potatoes are
usually added to the processing waste; therefore 30% is maximum for
potato feedstuffs).  Carrot culls will not be available for feeding
feedlot beef.  Dairy cows can be fed both.  However, HED has decided
that only one alternative type feedstuffs should be included in any
theoretical livestock diet.  For the dairy cow, of the two feedstuffs,
the carrot culls would be the major contributor to the dietary burden.

The results of the goat metabolism study (200x) relative to this revised
dietary burden (0.09 ppm, dairy) indicates that tolerances for residues
of cyazofamid in ruminants are not required for the purpose of petition,
PP# 1F06305 [40 CFR §180.6(a)(3)].

Tolerances for residues of cyazofamid in poultry commodities are not
required since there are no poultry feed items associated with the
proposed uses.  For poultry, the proposed uses also fall under 40 CFR
§180.6(a)(3).

860.1500 Crop Field Trials

47186801.DER

Residue data were submitted by AAFC (Agriculture and Agri-Food Canada)
and IR-4 (Interregional Research Project Number 4) to support the
establishment of an MRL/tolerance for the combined residues of
cyazofamid and its metabolite, CCIM in/on carrots for the control of
Pythium root dieback, cavity spot, and forking diseases.  Fourteen
residue trials were conducted in Canada and in the US in the 2004-2005
growing season in Zone 1A (1 in Prince Edward Island), Zone 2 (1 in
Georgia), Zone 3 (1 in Florida), Zone 5 (1 in Michigan, 2 in Manitoba),
Zone 5B (2 in Quebec), Zone 6 (1 in Texas), Zone 10 (4 in California),
and Zone 11 (1 in Washington).

Cyazofamid, formulated as a soluble concentrate, was applied as one
broadcast application to the soil and as four foliar treatments to
carrots, at rates ranging from 163.2 – 186.1 g a.i./ha [0.146 0.1660
lb. a.i./A/application], with a re-treatment interval of 12 – 92 days,
for total seasonal rates ranging from 852.9 – 904.6 g a.i./ha [0.80
– 0.81 lb. a.i./A].  An adjuvant was not added to the spray mixture in
any of the applications. There were one or two treated plots at each
site, with applications timed to harvest at a 14-day PHI.

Residues of cyazofamid in treated carrot samples ranged from < 0.01 ppm
to 0.045 ppm and residues of CCIM (corrected for storage dissipation)
were all < 0.02 ppm (i.e. combined residues of cyazofamid and CCIM
ranged from 0.03 ppm to 0.065 ppm) at the target PHI of 14 days (13 –
16 days) as summarized in Table C.2.   Two residue decline trials did
not indicate residues declined with increasing PHI.

TABLE C.2.	Summary of Residue Data from Crop Field Trials with
Cyazofamid.

Commodity	Total Applic. Rate

g a.i./ha

[lb. a.i./A]	PHI (days)	Residue Levels

 (ppm)

	n	Min.	Max.	HAFT1	Median

(STMdR)	Mean

(STMR)	Std. Dev.

Cyazofamid

Carrot	852.9 - 904.6

[0.7992-0.8070]	13-16	36	<0.01	0.045	0.039 	0.01	0.018 	0.010

CCIM

Carrot	852.9 – 904.6

[0.7992-0.8070]	13-16	36	<0.022	<0.02 2	<0.02 2	<0.02 2	<0.02 2	0

1HAFT = Highest Average Field Trial.

2Values were corrected to account for residue decline (58%) due to
storage.

Conclusion:  The crop field trials for cyazofamid in/on carrots are
considered scientifically valid.  The number and locations of  the field
trials are in accordance OPPTS Guideline 860.1500.  The results did not
differ when crops were irrigated immediately after treatment (Treatment
2) or under the worst case scenario where irrigation was delayed for 24
hour after the third, fourth and fifth treatments (Treatment 3).   The
use pattern of the field trials reflect the use pattern proposed for
carrots.  Two residue decline trials did not indicate that the residues
declined with increasing PHI.  Based on the tolerance calculation for
carrot (see Appendix II) the available field trial data will support a
tolerance of 0.09 ppm for the combined residues of cyazofamid and CCIM
in/on carrots.

860.1520 Processed Food and Feed

No processed commodities are associated with carrots.

860.1850 Confined Accumulation in Rotational Crops

No confined accumulation in rotational crop study was submitted with
this petition.  However, studies were submitted in conjunction with an
earlier petition (PP#1F06305) using test substances that were
radiolabeled in either the phenyl ring ([benzene-14C]cyazofamid) or in
the 4th position of the imidazole ring ([imidazole-14C]cyazofamid).
Loamy sand soil were treated separately with the test substances at the
maximum seasonal rate of 0.445 lb ai/A and aged for 31, 119, and 360
days prior to seeding with lettuce (a leafy vegetable), carrot (a root
vegetable), and wheat (a cereal grain).   The total radioactive residues
(TRR) were determined in mature and immature crop commodities.  The
results showed that the TRR in the [imidazole-14C] cyazofamid treated
samples were, overall, higher than the [benzene-14C]cyazofamid treated
samples and that residues were generally highest in samples from the 31
plant-back interval (PBI), and decreased to <0.01 ppm in the mature
lettuce, carrot root, and wheat grain sample at the 360-day PBI.
Residue characterization from the 31-day PBI with TRR >0.01 ppm
identified cyazofamid (0.2-0.6% TRR) as a minor residue component along
with the following metabolites: CCIM (0.2-0.9% TRR), CCIM-AM (0.1-0.9%
TRR), and CCBA (0.1-1.3% TRR).  The majority of radioactivity eluted at
the solvent front suggested that much of the bound residue was due to
incorporation of the label into biomolecules, consistent with the
results from the plant metabolism studies conducted on potatoes,
tomatoes and grapes.

860.1900 Field Accumulation in Rotational Crops

No data was submitted in support of this petition on carrots.  Based on
the confined rotational crop studies in PP# 1F06305 (see 45409036.DER),
HED did not require a field accumulation study in rotational crops
(OPPTS 860.1900) and did not require tolerances for rotational crop
commodities to be established.  These determinations were based on the
results of the study which showed that cyazofamid and structurally
related metabolites are not expected to be present at a level greater
than 0.01 ppm in/on three representative rotational crop commodities at
a plant back interval of 30 days.

Proposed Tolerance

The petitioners proposed the establishment of a permanent tolerance for
the combined residues of cyazofamid and CCIM in/on carrot, root at 0.06
ppm.   The Agency’s Guidance for Setting Pesticide Tolerances Based on
Field Trial Data was utilized for determining the appropriate tolerance
levels for carrot root (Appendix II).  The available field trial data
indicate that the proposed tolerance for carrot needs to be increased to
0.09 ppm.  The Section F should be revised to reflect the recommended
tolerance level as specified in Table D.

Presently, there are no maximum residue limits (MRL) established by
Codex, Canada or Mexico for cyazofamid.  Therefore, harmonization is not
an issue (Appendix I).

Table D.  Tolerance Summary of the Proposed and Recommended Tolerance
for the Combined Residues of Cyazofamid and CCIM.

Commodity	Proposed Tolerance

(ppm)	Recommended Tolerance

(ppm)	Residue Definition

Carrot, root	          0.06	              0.09	Combined Residues of
Cyazofamid,
4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfonam
ide and its metabolite, CCIM,
4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile

E.	REFERENCES

MRID No. 47186801/PMRA No. 1460112. Barney, W.P. (2007) Cyazofamid:
Magnitude of the Residue on Carrot: Lab Project Number: 08522. Study No.
08522.04-CAR05 Unpublished study prepared by Interregional Research
Project #4, Rutgers, The State University of New Jersey, Princeton, New
Jersey. 341 pages.

PMRA No. 1460007. Kane, S. (2001) Independent Laboratory Validation of
the Residue Method for IKF-916 and CCIM in tomatoes, Document Number
013033-0, Unpublished study prepared by Pyxant Labs Inc. Colorado
Springs, Colorado. 34 pages.

DP#:	285650

Subject:	PP# 1F06305.  Cyazofamid. Petition for the Establishment of
Permanent Tolerances for use on Cucurbits, Potatoes, Tomatoes, and
Imported Wine Grapes.  Summary of Analytical Chemistry and Residue Data.

From:	Amelia M. Acierto

To:	Janet Whitehurst/Cynthia Giles-Parker, PM Team #22

Date:	2/20/2004

MRID Nos:	45638502–45638510, 45409014-45409020, 45409022-45409036.

F.	DOCUMENT TRACKING

Petition Number:      7F7244

DP #:	343419

PC Code:	         085651

ATTACHMENTS:

APPENDIX I:		INTERNATIONAL RESIDUE LIMIT STATUS

APPENDIX II:	TOLERANCE ASSESSMENT CALCULATION

Template Version June 2005.

APPENDIX  I

  SEQ CHAPTER \h \r 1  INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:

4-Chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfonam
ide

	Common Name:  Cyazofamid

☐  Proposed tolerance

☐ Reevaluated tolerance

x Other  (updated)	Date:  02/28/2008

Codex Status (Maximum Residue Limits)	U. S. Tolerances

X  No Codex proposal step 6 or above

☐  No Codex proposal step 6 or above for the crops

      Requested	Petition Number:  PP# 7F7244

DP Barcode:  D343419

Other Identifier: IKF-916

Residue definition (step 8/CXL): N/A	Reviewer/Branch:  A. Acierto/RAB3

Crop (s)	MRL (mg/kg)	Crop(s) 	Tolerance (ppm)

Residue definition:    Combined Residues of Cyazofamid,
4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfonam
ide and its Metabolite, CCIM,
4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile

Carrot, root	0.09

Cucurbit vegetables, Group 9	0.10

Potatoes	0.02

Residue definition:  Combined Residues of Cyazofamid,
4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfonam
ide and its Metabolite, CCIM,
4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile

Tomato	0.20

Grape, wine *import	1.5

Limits for Canada	Limits for Mexi潣܇⁘丠楌業獴

☐  No Limits for the crops requested	X  No Limits

☐  No Limits for the crops requested

Residue definition: N/A	Residue definition: N/A

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (mg/kg)

Notes/Special Instructions:

S.Funk, 03/11/2008

APPENDIX  II.  TOLERANCE ASSESSMENT CALCULATION.

For each of the crops listed below, the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP, along with the tolerance
spreadsheet, was used for calculating recommended tolerances.  As
specified in the SOP, the minimum of the 95% upper confidence limit
(UCL) on the 95th percentile and the point estimate of the 99th
percentile was selected as the tolerance value in cases when the dataset
was large (greater than 15 samples) and reasonably lognormal.  For
datasets that were small (≤15 samples) and reasonably lognormal, the
upper bound estimate of the 95th percentile based on the median residue
value was compared to the minimum of the 95% UCL on the 95th percentile
and the point estimate of the 99th percentile, and the minimum value was
selected as the tolerance value.  For datasets that were not lognormal,
the upper bound on the 89th percentile was selected as the tolerance
value (distribution-free method).  The rounding procedures specified in
the SOP were also used.

Carrot, root

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ranged from <LOQ (<0.01 ppm) to 0.045 ppm and and CCIM were <LOQ.
Values below the LOQ are generally referred to as censored data.   The
use of maximum likelihood estimation (MLE) techniques to estimate the
mean and standard deviation of dataset is normally recommended if more
than 10-15% of the dataset is censored but not for datasets with large
degree of censoring (i.e., >60%) since the technique becomes unreliable.

Since >50% of the field trial samples were below the LOQ, the MLE
procedure was used to impute censored values.  The residue data were
first entered into the MLE spreadsheet to obtain the estimated values
and the cyazofamid MLE and CCIM MLE data set were then entered into the
tolerance spreadsheet.  After entering the MLE dataset into the
spreadsheet, visual inspection of the lognormal probability plot  (Fig.
1) indicates that the dataset is reasonably lognormal.  The result from
the S-F test statistic (Fig. 2) confirmed that the assumption of
lognormality should not be rejected.

The petitioners have proposed a tolerance of 0.06 ppm. The available
data indicate that 0.09 ppm is an appropriate value for the tolerance
for carrot, root.

Page   PAGE  1  of   NUMPAGES  17


[Federal Register: August 4, 2009 (Volume 74, Number 148)]
[Notices]
[Page 38676-38677]
[DOCID:fr04au09-84]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[ File No. 500-1]

 In the Matter of Gulf Alternative Energy Corporation; Order of
Suspension of Trading

July 31, 2009.

    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Gulf Alternative Energy Corporation (trading symbol: GAEC) because of
questions regarding the accuracy and adequacy of information contained
in press releases and on its website regarding the quality of the
company's technology and the company's business prospects and
agreements.
    The Commission is of the opinion that the public interest and the
protection of the investors require a suspension of trading in the
securities of Gulf Alternative Energy Corporation.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed company is suspended for the period from 9:30 a.m. EDT,
July 31, 2009, through 11:59 p.m. EDT, on August 13, 2009.

    By the Commission.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-18669 Filed 7-31-09; 4:15 pm]

BILLING CODE 8010-01-P


[Federal Register: May 5, 2008 (Volume 73, Number 87)]
[Notices]
[Page 24585]
[DOCID:fr05my08-463]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12667-003]

City of Hamilton, Ohio; Notice of Availability of Environmental
Assessment

April 25, 2008.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR Part 380 (Order No. 486, 52 FR 47897), the Office
of Energy Projects has reviewed the application for an Original Major
License for the Meldahl Hydroelectric Project.
    The project would be located at the Captain Anthony Meldahl Locks
and Dam and would occupy about 81 acres of federal lands administered
by the Huntington District of the U.S. Army Corps of Engineers. Staff
has prepared an environmental assessment (EA) for the project.
    The EA contains staff's analysis of the potential environmental
effects of the project and concludes that licensing the project, with
appropriate environmental protective measures, would not constitute a
major federal action that would significantly affect the quality of the
human environment.
    A copy of the EA is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,
202-502-8659.
    Any comments should be filed within 30 days from the date of this
notice and should be addressed to: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426. Please affix Project No. 12667-003 to all comments. Comments may
be filed electronically via the Internet in lieu of paper. The
Commission strongly encourages electronic filings. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
(http://www.ferc.gov) under the ``e-Filing'' link.
    For further information, please contact Peter Leitzke at 202-502-
6059 or at<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. E8-9780 Filed 5-2-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: September 5, 2007 (Volume 72, Number 171)]
[Proposed Rules]
[Page 50913-50916]
[DOCID:fr05se07-13]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R07-OAR-2007-0655; FRL-8462-8]

Approval and Promulgation of State Plans for Designated
Facilities and Pollutants; Iowa; Clean Air Mercury Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing to approve the State Plan submitted by Iowa
on August 15, 2006, and revisions submitted on April 26, 2007. The plan
addresses the requirements of EPA's Clean Air Mercury Rule (CAMR),
promulgated on May 18, 2005, and subsequently revised on June 9, 2006.
EPA is proposing to determine that the submitted State Plan fully meets
the CAMR requirements for Iowa.
    CAMR requires States to regulate emissions of mercury (Hg) from
large coal-fired electric generating units (EGUs). CAMR establishes
State budgets for annual EGU Hg emissions and requires States to submit
State Plans to ensure that annual EGU Hg emissions will not exceed the
applicable State budget. States have the flexibility to choose which
control measures to adopt to achieve the budgets, including
participating in the EPA-administered CAMR cap-and-trade program. In
the State Plan that EPA is proposing to approve Iowa would meet CAMR
requirements by participating in the EPA trading program.

DATES: Comments must be received on or before October 5, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2007-0655, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Mail: Michael Jay, Environmental Protection Agency, Air Planning
and Development Branch, 901 North 5th Street, Kansas City, Kansas
66101.
    4. Hand Delivery or Courier: Deliver your comments to: Michael Jay,
Environmental Protection Agency, 901 North 5th Street, Kansas City,
Kansas 66101. Such deliveries are only accepted during the Regional
Office's normal hours of operation. The Regional Office's official
hours of business are Monday through Friday, 8 a.m. to 4:30 p.m.,
excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R07-OAR-
2007-0655. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit through http://www.regulations.gov
 or e-mail, information that you consider to be CBI

or otherwise protected. The http://www.regulations.gov Web site is an

``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA

cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters
and any form of encryption and should be free of any defects or
viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov
 or in hard copy at the Environmental Protection

Agency, Air Planning and Development Branch, 901 North 5th Street,
Kansas City, Kansas 66101. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Michael Jay at<PHONE_NUMBER> or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. What Action Is EPA Proposing to Take?
II. What Is the Regulatory History of CAMR?
III. What Are the General Requirements of CAMR State Plans?
IV. How Can States Comply With CAMR?
V. Analysis of Iowa's CAMR State Plan Submittal
    A. State Budgets
    B. CAMR State Plan
VI. Statutory and Executive Order Reviews

I. What Action Is EPA Proposing to Take?

    EPA is proposing to approve Iowa's State Plan, submitted on August
15, 2006, and April 26, 2007. In its State Plan, Iowa would meet CAMR
by requiring certain coal-fired EGUs to participate in the EPA-
administered cap-and-trade program addressing Hg emissions. EPA is
proposing to determine that the State Plan meets the applicable
requirements of CAMR.

II. What Is the Regulatory History of CAMR?

    CAMR was published by EPA on May 18, 2005 (70 FR 28606, ``Standards
of Performance for New and Existing Stationary Sources: Electric
Utility Steam Generating Units; Final Rule''). In this rule, acting
pursuant to its authority under section 111(d) of the Clean Air Act
(CAA), 42 U.S.C. 7411(d), EPA required that all States and the District
of Columbia (all of which are referred to herein as States) meet
Statewide annual budgets limiting Hg emissions from coal-fired EGUs (as
defined in 40 CFR 60.24(h)(8)) under CAA section 111(d). EPA required
all States to submit State Plans with control measures that ensure that
total, annual Hg emissions from the coal-fired EGUs located in the
respective States do not exceed the applicable statewide annual EGU
mercury budget. Under CAMR, States may implement and enforce these
reduction requirements by participating in the EPA-administered cap-
and-trade program or by adopting any other effective and enforceable
control measures.
    CAA section 111(d) requires States, and along with CAA section
301(d) and the Tribal Air Rule (40 CFR part 49) allows Tribes granted
treatment as States (TAS), to submit State Plans to EPA that implement
and enforce the standards of performance. CAMR explains what must be
included in State Plans to address the requirements of CAA section
111(d). The State Plans were due to EPA by November 17, 2006. Under 40
CFR 60.27(b), the Administrator will approve or disapprove the State
Plans.

III. What Are the General Requirements of CAMR State Plans?

    CAMR establishes Statewide annual EGU Hg emission budgets and is to
be implemented in two phases. The first phase of reductions starts in
2010 and continues through 2017. The second phase of reductions starts
in 2018 and continues thereafter. CAMR requires States to implement the
budgets by either: (1) Requiring coal-fired EGUs to participate in the
EPA-administered cap-and-trade program; or (2) adopting other coal-
fired EGU control measures of the respective State's choosing and
demonstrating that such control measures will result in compliance with
the applicable State annual EGU Hg budget.
    Each State Plan must require coal-fired EGUs to comply with the
monitoring, recordkeeping, and reporting provisions of 40 CFR part 75
concerning Hg mass emissions. Each State Plan must also show that the
State has the legal authority to adopt emission standards and
compliance schedules necessary for attainment and maintenance of the
State's annual EGU Hg budget and to require the owners and operators of
coal-fired EGUs in the State to meet the monitoring, recordkeeping, and
reporting requirements of 40 CFR part 75.

IV. How Can States Comply With CAMR?

    Each State Plan must impose control requirements that the State
demonstrates will limit Statewide annual Hg emissions from new and
existing coal-fired EGUs to the amount of the State's applicable annual
EGU Hg budget. States have the flexibility to choose the type of EGU
control measures they will use to meet the requirements of CAMR. EPA
anticipates that many States will choose to meet the CAMR requirements
by selecting an option that requires EGUs to participate in the EPA-
administered CAMR cap-and-trade program. EPA also anticipates that many
States may chose to control Statewide annual Hg emissions for new and
existing coal-fired EGUs through an alternative mechanism other than
the EPA-administered CAMR cap-and-trade program. Each State that
chooses an alternative mechanism must include with its plan a
demonstration that the State Plan will ensure that the State will meet
its assigned State annual EGU Hg emission budget.
    A State submitting a State Plan that requires coal-fired EGUs to
participate in the EPA-administered CAMR cap-and-trade program may
either adopt regulations that are substantively identical to the EPA
model Hg trading rule (40 CFR part 60, subpart HHHH) or incorporate by
reference the model rule. CAMR provides that States may only make
limited changes to the model rule if the States want to participate in
the EPA-administered trading program. A State Plan may change the model
rule only by altering the allowance allocation provisions to provide
for State-specific allocation of Hg allowances using a methodology
chosen by the State. A State's alternative allowance allocation
provisions must meet certain allocation timing requirements and must
ensure that total allocations for each calendar year will not exceed
the State's annual EGU Hg budget for that year.

V. Analysis of Iowa's CAMR State Plan Submittal

A. State Budgets

    In this action, EPA is proposing to approve Iowa's State Plan that
adopts the annual EGU Hg budgets established for the State in CAMR,
i.e., 0.727 tons for EGU Hg emissions in 2010-2017 and 0.287 tons for
EGU Hg emissions in 2018 and thereafter. Iowa's State Plan sets these
budgets as the total amount of allowances available for allocation for

each year under the EPA-administered CAMR cap-and-trade program.

B. CAMR State Plan

    The Iowa State Plan requires coal-fired EGUs to participate in the
EPA-administered CAMR cap-and-trade program. The State Plan
incorporates by reference the EPA model Hg trading rule but has adopted
an alternative allowance allocation methodology. Under the Hg allowance
allocation methodology in the model rule, Hg allowances are allocated
to units that have operated for 5 years, based on heat input data from
a 3-year period that are adjusted for coal rank by using coal factors
of 3.0 for the lignite combusted by the unit, 1.25 for the
subbituminous combusted by the unit, and 1 for other coal ranks
combusted by the unit. The model rule also provides a new unit set-
aside from which units without 5 years of operation are allocated
allowances based on the units' prior year emissions.
    States may establish in their State Plan submissions a different Hg
allowance allocation methodology that will be used to allocate
allowances to sources in the States if certain requirements are met
concerning the timing of submission of units' allocations to the
Administrator for recordation and the total amount of allowances
allocated for each control period. In adopting alternative Hg allowance
allocation methodologies, States have flexibility with regard to:
    1. The cost to recipients of the allowances, which may be
distributed for free or auctioned;
    2. The frequency of allocations;
    3. The basis for allocating allowances, which may be distributed,
for example, based on historical heat input or electric and thermal
output; and
    4. The use of allowance set-asides and, if used, their size.
    In Iowa's alternative allowance methodology, Iowa has modified the
portion of the model rule relating to the basis for allocating
allowances to new units commencing operation on or after January 1,
2001. In Iowa's rule 567-34.304, the State has limited the timeframe
within which a unit can meet the requirements to apply for allowances
under the new unit set-aside to units that commence operation on or
after January 1, 2001, and commence construction before January 1,
2006. As a result, one facility meets this criterion and is provided
the full allocation under the new source set-aside for both phases
amounting to 5 percent of the State's budget for phase I and 3 percent
for phase II. Also in the section relating to new units, in the event a
generator is served by two or more units, the nameplate capacity will
be attributed to each unit in equal fraction of the total nameplate
capacity multiplied by 7900 British Thermal Units per Kilowatt Hour for
the determination of heat input for each unit.
    Iowa's State Plan requires coal-fired EGUs to comply with the
monitoring, recordkeeping, and reporting provisions of 40 CFR part 75
concerning Hg mass emissions. Iowa's State Plan also demonstrates that
the State has the legal authority to adopt emission standards and
compliance schedules necessary for attainment and maintenance of the
State's annual EGU Hg budget and to require the owners and operators of
coal-fired EGUs in the State to meet the monitoring, recordkeeping, and
reporting requirements of 40 CFR part 75. Iowa cites Section 455B.133
of the Iowa Code, which contains the broad enabling authority for
Iowa's air pollution control regulations, as containing the legal
authority for the Iowa Environmental Protection Commission to adopt the
State's rule that allows for Iowa's participation in the nationwide cap
and trade program for mercury.
    Iowa has committed to revise a definition in its rule to fully
ensure allowances can be traded among all sources participating in the
EPA-administered cap-and-trade program for mercury as intended. EPA
discovered after review of other States' rules, but after Iowa had
adopted its Clean Air Interstate Rule (CAIR) and CAMR rules, an issue
related to the definition of ``permitting authority'' when it is
revised to refer to a specific State's permitting authority.
    In Iowa's rule designed to meet CAMR, the EPA model trading rule
was revised to limit all references to ``permitting authority'' to
refer to the Iowa Department of Natural Resources. This change is
acceptable in most, but not all, instances under the current model
rule. In certain definitions in the model rule incorporated by Iowa
(i.e., ``allocate'' or ``allocation,'' and ``Hg allowance''), it is
important that the term ``permitting authority'' cover permitting
authorities in all States that choose to participate in the respective
EPA-administered trading program. This is necessary to ensure that all
allowances issued in the EPA-administered trading program are fungible
and can be traded and used for compliance with the allowance-holding
requirement in any State in the program.
    On February 17, 2007, EPA provided a letter to Iowa that requested
and outlined necessary definition revisions for all rules intended to
meet CAIR and CAMR. EPA received a letter from Iowa on February 28,
2007, that provided a commitment to make the EPA suggested rule
revisions as soon as is practicable upon publication of the final rule
concerning the proposed Clean Air Mercury Rule (CAMR) Federal plan. The
CAMR Federal plan was proposed on December 22, 2006, and the rulemaking
also included changes to the CAMR model rule to integrate it with the
proposed Federal plan. Any final changes will need to be incorporated
in State rules, and Iowa prefers to wait and make one set of amendments
to its State rule to address both the above-referenced definition
changes and any final changes to the CAMR model rule reflecting the
final Federal plan. On April 11, 2007, EPA received an electronic
correspondence from Iowa stating that Iowa will, in any event, complete
these rule revisions before January 1, 2008. The State will be able to
simultaneously revise the ``permitting authority'' definition in all
cap-and-trade rules for both CAIR and CAMR, and properly update the
State's rule as necessary to meet the requirements of the EPA-
administered cap-and-trade-program for mercury.
    The final rule concerning the CAMR Federal plan is expected to be
published before the earliest, major deadline for compliance with
requirements for source owners and operators under the CAIR trading
programs, i.e., the January 1, 2008, deadline for emissions monitoring
requirements under the CAIR Annual Trading Program. EPA expects that,
by timing adoption of the EPA requested rule revisions to both Iowa's
CAIR and CAMR rules to be soon after the publication of the final rule
concerning the CAMR Federal plan, the State will ensure the revisions
to the definition of ``permitting authority'' will be completed prior
to any of the major compliance deadlines for source owners and
operators under the CAIR trading programs. Even if the final rule
concerning the CAMR Federal plan is not published in the expected
timeframe, the State will still need to ensure the necessary State rule
revisions are completed and submitted to EPA in advance of January 1,
2008.

VI. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May

22, 2001). This action merely proposes to approve State law as meeting
Federal requirements and would impose no additional requirements beyond
those imposed by State law. Accordingly, the Administrator certifies
that this proposed rule would not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.). Because this action proposes to approve
pre-existing requirements under State law and would not impose any
additional enforceable duty beyond that required by State law, it does
not contain any unfunded mandate or significantly or uniquely affect
small governments, as described in the Unfunded Mandates Reform Act of
1995 (Pub. L. 104-4).
    This proposal also does not have Tribal implications because it
would not have a substantial direct effect on one or more Indian
tribes, on the relationship between the Federal Government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian tribes, as specified by Executive
Order 13175 (65 FR 67249, November 9, 2000).
    This proposed action also does not have Federalism implications
because it would not have substantial direct effects on the States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132 (64 FR 43255,
August 10, 1999). This action merely proposes to approve a State rule
implementing a Federal standard. It does not alter the relationship or
the distribution of power and responsibilities established in the CAA.
This proposed rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it proposes to approve a
State rule implementing a Federal standard.
    Executive Order 12898, ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations,'' requires
Federal agencies to consider the impact of programs, policies, and
activities on minority populations and low-income populations. EPA
guidance \1\ states that EPA is to assess whether minority or low-
income populations face risk or a rate of exposure to hazards that is
significant and that ``appreciably exceed[s] or is likely to
appreciably exceed the risk or rate to the general population or to the
appropriate comparison group.'' (EPA, 1998) Because this rule merely
proposes to approve a state rule implementing the Federal standard
established by CAMR, EPA lacks the discretionary authority to modify
today's regulatory decision on the basis of environmental justice
considerations. However, EPA has already considered the impact of CAMR,
including this Federal standard, on minority and low-income
populations. In the context of EPA's CAMR published in the Federal
Register on May 18, 2005, in accordance with Executive Order 12898, the
Agency has considered whether CAMR may have disproportionate negative
impacts on minority or low income populations and determined it would
not.
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    \1\ U.S. Environmental Protection Agency, 1998. Guidance for
Incorporating Environmental Justice Concerns in EPA's NEPA
Compliance Analyses. Office of Federal Activities, Washington, DC,
April, 1998.
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    In reviewing State Plan submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the CAA. In this
context, in the absence of a prior existing requirement for the State
to use voluntary consensus standards (VCS), EPA has no authority to
disapprove a State Plan for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a State Plan
submission, to use VCS in place of a State Plan submission that
otherwise satisfies the provisions of the CAA. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This proposed rule would
not impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

List of Subjects in Part 62

    Environmental protection, Air pollution control, Electric
utilities, Intergovernmental relations, Mercury, Reporting and
recordkeeping requirements.

    Dated: August 23, 2007.
John B. Askew,
Regional Administrator, Region 7.
[FR Doc. E7-17414 Filed 9-4-07; 8:45 am]

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