the general U.S. population and all population subgroups.

As noted above, EPA has assumed that BAM’s potential for
carcinogenicity is similar to that of  dichlobenil, which is classified
as “Group C, possible human carcinogen” with the RfD approach
utilized for quantification of human risk.  The quantification of cancer
risk using the RfD approach is identical to the assessment for chronic
effects; no separate carcinogenic risk assessment is necessary.

8.0	Cumulative Risk Assessments and Risk Characterization  TC \l1 "8.0
Aggregate Risk Assessments and Risk Characterization

Unlike pesticides for which EPA has followed a cumulative risk approach
based on a common mechanism of toxicity, EPA has not made a common
mechanism of toxicity finding as to BAM and any other substances and BAM
does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has not assumed that BAM has a common mechanism of toxicity with other
substances. For information regarding EPA’s efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements released
by EPA’s Office of Pesticide Programs concerning common mechanism
determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA’s website at   HYPERLINK
http://www.epa.gov/pesticides/cumulative/.
http://www.epa.gov/pesticides/cumulative/.

Fluopicolide and dichlobenil can form the common metabolite BAM.  To
establish new tolerances for fluopicolide, EPA conducted this human
health risk assessment for exposure to BAM resulting from the use of
current and proposed uses of fluopicolide and the herbicide dichlobenil.
 The risk assessment is conservative in terms of potential dietary and
non-dietary exposures.  In addition, the Agency retained the additional
10X FQPA safety factor for the protection of infants and children.  The
assessment includes evaluations of risks for various subgroups,
including those composed of infants and children.

9.0	Occupational Exposure/Risk Pathway  TC \l1 "9.0	Occupational
Exposure/Risk Pathway

Occupational and Residential Risk Assessment of Metabolite BAM (to
Support Request for Registration of Fluopicolide on a Variety of Crops,
Residential Turf and Ornamentals), DP #345920, K. O’Rourke, 10/9/07

9.1	Short-/Intermediate-/Long-Term/Cancer (if needed) Handler Risk  TC
\l2 "9.1	Short-/Intermediate-/Long-Term/Cancer (if needed) Handler Risk

Occupational handler exposure was not evaluated because the metabolite
BAM is believed to form slowly in plants and soil after the product
containing the parent (fluopicolide) has been applied.

9.2	Short-/Intermediate-/Long-Term/Cancer (if needed) Postapplication
Risk  TC \l2 "9.2	Short-/Intermediate-/Long-Term/Cancer (if needed)
Postapplication Risk

The registration action for fluopicolide involves application to
agricultural crops as well as turf and ornamentals.  Postapplication
inhalation exposure is expected to be negligible, however, dermal
exposure to the metabolite BAM is possible for workers: entering treated
areas to tend or harvest crops, mow/maintain turfgrass, or tend
ornamentals in nurseries and greenhouses.  A dislodgeable foliar residue
(DFR) study on fluopicolide was submitted by the registrant (MRID#:
46708641) for use in assessing postapplication activities.  As discussed
in the fluopicolide assessment (K. O’Rourke, DP #326082, 10/9/07),
this study is considered to be acceptable, and the results indicate that
the initial dislodgeable residue of fluopicolide is 29% of the
application rate.  The data were considered applicable to residue
estimation for agricultural crops and ornamentals.  A turf transferable
residue (TTR) study was not available.  Therefore, turf scenario
calculations were based on the standard turf residue assumption of 5% of
the application rate for the initial transferable residue for
fluopicolide.

In order to adjust these estimates to reflect BAM residues, which were
not measured in the DFR study, data from plant metabolism studies were
considered.  Grape, lettuce, and potato metabolism data indicate that
the majority of total radioactive residue (TRR) was located on the
surface of foliage and fruit samples (DP #327026, A. Acierto, 8/20/07).
The parent fluopicolide was the primary residue identified in grape
fruit, lettuce leaves, and potato foliage and tubers, accounting for
51-98% TRR.  The metabolite BAM was found in foliarly-treated grapes
(fruit),  lettuce leaves, and potato foliage at <4% TRR.  Although BAM
was found at higher percentages in lettuce which had received soil
drench application (17-20% TRR) and potato tubers (12-26% TRR), the
actual concentration was lower than BAM occurring on grapes (fruit),
lettuce leaves, and potato foliage.  For the purposes of this
postapplication exposure assessment, it was conservatively assumed that
the surface residues of BAM are dislodgeable/transferable, and that they
are present at 4% of the initial amount of parent fluopicolide.

In addition to DFR and TTR, transfer coefficients (Tc) are used to
relate the residue values to activity patterns, which take place after
application, to estimate potential human exposure.  The transfer
coefficients used in this assessment are from an interim transfer
coefficient guidance document developed by HED’s Science Advisory
Council for Exposure using proprietary data from the Agricultural
Re-entry Task Force (ARTF) database (SOP# 3.1).

Postapplication MOEs are typically estimated for “Day 0" exposure
(i.e., the day of application).  As shown in Table 9.2, the
short-/intermediate-term MOEs for BAM are greater than the LOC of 100 on
the day of application for all agricultural, turf and ornamental uses of
fluopicolide, and are not of concern.

The fluopicolide technical material has been classified in Toxicity
Categories III-IV for acute dermal and primary skin irritation, and
Category III for primary eye irritation.  Per the Worker Protection
Standard (WPS), a 12-hr restricted entry interval (REI) is required for
chemicals classified under Toxicity Category III/IV.  The proposed
fluopicolide labels indicate an REI of 12 hrs, which is in compliance
with the WPS for uses that reach an MOE of 100 on the day of
application.  Fluopicolide is also intended for non-agricultural use
sites (e.g., golf course) to which the WPS does not apply; the labels
appropriately contain language cautioning unprotected persons to keep
out of treated areas until sprays have dried.

Table 9.2.  Summary of Estimated Post-application MOEs for Agricultural
Crops

Crop	Application Rate

(lb ai/A) 1	DAT 2	DFR or TTR 3

(μg/cm2)	TC 4

(cm2/hr)	Activity 4	Short-/Int-

Term MOE 5

Agricultural Crops

Fruiting Vegetables	0.13	0	0.017	500	Irrigation, scouting, thinning,
weeding immature plants	26,000

700	Irrigation and scouting mature plants	18,000

1,000	Hand harvesting, pruning, staking, tying	13,000

Cucurbit & Leafy Vegetables

0	0.017	500	Irrigation, scouting, thinning, weeding immature plants
26,000

1,500	Irrigation, scouting, weeding mature plants	8,600

2,500	Hand harvesting, pulling, pruning, and thinning mature plants
5,200

Grapes

0	0.017	500	Hedging, irrigation, scouting, hand weeding	26,000

1,000	Scouting	13,000

5,000	Hand harvest, leaf pulling, thinning, pruning, training/tying
2,600

10,000	Girdling and cane turning	1,300

Sweet Potatoes

0	0.017	300	Irrigation, scouting, thinning, weeding immature plants
43,000

1,500	Irrigation and scouting mature plants	8,600

2,500	Hand harvesting	5,200

Turf

Turf	0.27	0	0.0060

3,400	Mowing and other maintenance activities	11,000

6,800	Sod harvesting and transplanting	5,300

Ornamentals – Nursery Stock

Nursery Stock	0.54	0	0.070	100	Hand pruning containerized ornamentals
31,000

400	Harvesting, ball/burlap containerized ornamentals	7,800

Ornamentals – Cut Flowers

Cut Flowers	0.54	0	0.070	500	Pinching	6,200

5,100	Hand harvesting, pruning, thinning, pinching	610

1 Maximum application rate from proposed fluopicolide labels.

2 DAT = Days after treatment needed to reach the LOC of 100; DAT 0 = The
day of treatment, after sprays have dried; assumed to be approximately
12 hours.

3 DFR or TTR (µg/cm2) = dislodgeable foliar residues (for agricultural
crops and ornamentals) corresponding to DAT, based on results from a
fluopicolide-specific DFR study (MRID 46708641) or turf transferable
residue based on the standard assumption for turf.  Plant metabolism
data were used to adjust residues for amount of BAM.

4 TC (cm2/hr) = transfer coefficients and associated activities from
ExpoSAC Policy Memo #003.1 “Agricultural Transfer Coefficients”,
8/17/2000.

5 MOE = MOE on the corresponding DAT.  MOE = NOAEL / Daily Dose.

   Daily Dose = [(TTR or DFR x  TC x 100% Dermal absorption  x  8-hr
Exposure Time)] / [(CF: 1000 µg/mg) x (70-kg Body Weight)]

   Short-/intermediate-term NOAEL = 25 mg/kg/day.  The LOC is 100.10.0
Data Needs and Label Recommendations  TC \l1 "10.0	Data Needs and Label
Recommendations

10.1	Toxicology  TC \l2 "10.1	Toxicology

None.

10.2	Residue Chemistry  TC \l2 "10.2	Residue Chemistry

Refer to the Fluopicolide Risk Assessment Document, DP #325091 (N. Dodd,
11/21/07).

10.3	Occupational and Residential Exposure   TC \l2 "10.3	Occupational
and Residential Exposure

None.

References:  TC \l1 "References:

Fluopicolide.  PP#5F7016.  Petition for Establishment of Tolerances for
Use on Tuberous and Corm Vegetables, Leafy Vegetables (except Brassica),
Fruiting Vegetables, Cucurbit Vegetables, Grapes and on the Rotational
Crop Wheat.  Summary of Analytical Chemistry and Residue Data, DP
Number326080, Amelia Acierto, 11/19/07.

2,6-Dichlorobenzamide (BAM) as a Metabolite of Fluopicolide and
Dichlobenil.  Acute and Chronic Aggregate Dietary (Food and Drinking
Water) Exposure and Risk Assessments for the Section 3 Registration
Actions for Fluopicolide on Tuberous and Corm Vegetables, Leafy
Vegetables (except Brassica), Fruiting Vegetables, Cucurbit Vegetables,
and Grapes, and for Indirect or Inadvertent Residues on the Rotational
Crop Wheat, DP Number 340366, N. Dodd, 11/21/07.

Occupational and Residential Risk Assessment of Metabolite BAM (to
Support Request for Registration of Fluopicolide on a Variety of Crops,
Residential Turf and Ornamentals), DP #345920, K. O’Rourke, 10/9/07.

Drinking Water Assessment for the BAM (2,6-Dichlorobenzamide) Degradate
of Dichlobenil, DP #340773, J. Angier, Ph.D., 8/29/07.

Drinking Water Exposure Assessment for Fluopicolide Uses on Grapes,
Vegetables, Potatoes, Sugar Beet, Onion, and Turf – Exposure of
2,6-Dichlorobenzamide (BAM), DP #325804, J. Lin, 5/3/07.

Appendix A:  Toxicity Profile Table and Executive Summaries/Published
Abstracts   TC \l1 " Appendix A:  Toxicity Profile Table and Executive
Summaries/Published Abstracts

Table 3.1a.  Acute toxicity profile for soil metabolite
2,6-dichlorobenzamide (BAM)a

Guideline No./Study Type

MRID No.

Results	Toxicity Category

870.1100/Acute oral toxicity (mouse)	42940201	LD50 ≥ 1538/1144 mg/kg
(M/F)	III

870.1100/Acute oral toxicity (rat)	46708602	LD50 ≥ 2000  mg/kg (M) and
 LD50 ≥300 mg/kg (F)	II

a According to Reregistration Eligibility Decision (1998)

Table 3.1b.  SUBCHRONIC, CHRONIC, AND GENO- TOXICITY PROFILE FOR
METABOLITE, 2,6-DICHLOROBENZAMIDE (BAM)

Guideline No./

Study Type

MRID No. (Year)/Doses/ Classification

Results

870.3100

90-day oral (rat; dietary)

00067654 (1967)

0, 50, 180, 600, or 2300 ppm (equal to 0, 4, 14, 49, or 172 mg/kg/day)

Acceptable/Guideline

NOAEL = 14 mg/kg/day

LOAEL = 49 mg/kg/day based on decreased body weight gain (M) and reduced
skeletal muscle tone (M&F)

870.3150

90-day oral (dog; dietary)

00067655 (1967)

0, 100, 300, or 2000 ppm (equal to 0, 7.5, 22.5, or 150 mg/kg/day)

Unacceptable/Guideline due to parasitic infections (ascariasis) in most
animals

NOAEL = 22.5 mg/kg/day

LOAEL = 150 mg/kg/day based on clinical signs (thin appearance, dull
coat, hair loss) and increased liver weight and serum alkaline
phosphatase concentrations (F) and clinical signs (thin appearance, dull
coat, hair loss) (M)

870.4700

Chronic toxicity oral (dogs; dietary)

42940203 (1971)

0, 60, 100, 180, or 500 ppm (equal to 0, 1.5, 2.5, 4.5, or 12.5
mg/kg/day)

Acceptable/Guideline

NOAEL = 4.5 mg/kg/day

LOAEL = 12.5 mg/kg/day based on decreased body weight and body weight
gain

870.4300

Combined Chronic Toxicity/ Carcinogenicity oral (rat; dietary)

42940202 (1971), 44043601 (1996), 44052901 (1996)

0, 60, 100, 180, or 500 ppm [equal to 0, 2.2/2.8, 3.6/4.7, 6.5/8.5, or
19/25 mg/kg/day (M/F)]

Acceptable/Guideline

NOAEL = 6.5 (M) and 4.7 mg/kg/day (F)

LOAEL = 19 mg/kg/day (M) and 8.5 mg/kg/day (F) based on decreased body
weight and body weight gain (≥ week 26) and an increased incidence of
hepatocellular alteration (eosinophilic foci)

Borderline statistically significant (P=0.049) increased incidence of
hepatocellular adenomas at 25 mg/kg/day (F only); dosing considered
adequate (M&F)

870.3700

Developmental toxicity oral (rabbit; gavage)

43003601 (1986), 43265201 (1994)

0, 10, 30, or 90 mg/kg/day

Acceptable/Guideline

Maternal NOAEL= 30 mg/kg/day

Maternal LOAEL= 90 mg/kg/day based on increased incidences of clinical
signs (late abortion, thin appearance) and decreased (severe) body
weight gain and food consumption during dosing

Developmental NOAEL = 30 mg/kg/day

Developmental LOAEL = 90 mg/kg/day based on increased

incidences of late abortion and skeletal (bipartite interparietal

bone) and visceral (postcaval lung lobe agenesis) anomalies

870.3800

3-generation reproduction oral (rat; dietary)

	42940204 (1971)

0, 60, 100, or 180 ppm (equivalent 0, 4.5, 7.5, or 13.5 mg/kg/day)

Unacceptable/Guideline due to lack of individual animal data	Parental
NOAEL = 13.5 mg/kg/day

Parental LOAEL was not observed.

Reproductive NOAEL = 13.5 mg/kg/day

Reproductive LOAEL was not observed.

Offspring NOAEL = 13.5 mg/kg/day

Offspring LOAEL was not observed.

Non-guideline (literature)

Adult mouse olfactory study (single injection; i.p.)	Brittebo et al.
(1991); no MRID

0, 25, 50, or 100 mg/kg/day (i.p.)

cus production) observed at ≥25 mg/kg/day (reversible); degeneration
of olfactory epithelium and necrosis of Bowman’s glands observed at
100 mg/kg/day (sustained)

870.5100

In vitro bacterial reverse mutation (Ames test)

43003603 (1992)

At concentrations up to 5000 g/plate (-/+ activation) in S.
typhimurium

Acceptable/Guideline

Negative with or without activation.

870.5395

In vivo mouse erythrocyte micronucleus assay

43003602 (1993), 43747101 (1995)

0, 250 mg/kg

Acceptable/Guideline

Negative.

Lethargy observed in dose-range finding (pilot) study at 100 mg/kg/day
(=LOAEL; NOAEL not observed); clinical signs worsened with increasing
dose

870.5550

In vitro Unscheduled DNA synthesis (rat hepatocytes)

43003604 (1993)

g/ml

Acceptable/Guideline

Negative.

BAM

90-day rat

In a 13-week oral toxicity study (MRID 00067654), 2,6-dichlorobenzamide
technical (dichlobenil soil metabolite) (batch # 133/2/4/104; purity not
reported) was administered to 10 Wistar rats/sex/dose in the diet at
dose levels of 0, 50, 180, 600, or 2300 ppm (equal to 0, 4, 14, 49, or
172 mg/kg bw/day).

There were no treatment-related effects on survival.  Increased
relaxation scores (muscle hypotonus; P<0.05) were observed at 600 ppm on
day 4 only in males and on days 91 and 92 only in females (Table 1).  At
2300 ppm, increases in relaxation scores (P<0.05) were observed at each
measurement in both sexes.  Mean terminal body weights were decreased in
both males (18%) and females (11%) at 2300 ppm, relative to controls.
Mean body weight gain in males treated at 2300 ppm was decreased by 30%
(P=0.01) during weeks 2-11, while food consumption in the same group was
decreased by 16% (P=0.01).  In females, mean body weight gain was
decreased by 18% (P=0.01) after 11 weeks at 600 ppm and by 30% (P=0.01)
at 2300 ppm.  Food consumption was decreased by 17% (P=0.01) at 2300 ppm
only.

No treatment-related changes were observed in hematological or
urinalysis parameters.  A 19% (P=0.02) decrease in mean blood
coagulation time in males at 2300 ppm was not considered clinically
significant and was also not dose-dependent.  Mean serum urea
concentration in males was increased by 55% (P<0.001) after 6 weeks at
2300 ppm.  After 12 weeks in males, mean serum urea concentration was
increased by 53% (P=0.04) at 600 ppm and by 69% (P=0.04) at 2300 ppm.
In the absence of histopathological correlates in the kidney or liver,
increased urea concentrations were not considered toxicologically
significant.  No biologically significant changes in clinical chemistry
were observed in females.  There was also no difference in
bromosulphthalein serum retention (measure of liver function) between
control and high-dose animals.

Mean absolute thymus, heart, and brain weights were decreased in males
by 28% (P=0.01), 21% (P=0.01), and 7% (P=0.01), resp., while mean
absolute spleen, thymus, and heart weights were decreased in females by
13% (P=0.05), 23% (P=0.01), and 9% (P=0.01), resp.  However, there was
no difference in mean relative weights for these organs in either sex,
and the differences from control are likely related to the observed
decreases in body weight.  For these reasons and because
histopathological correlates were lacking in these organs, the changes
in organ weights were not considered toxicologically significant.

The LOAEL for males is 600 ppm (49 mg/kg/day), based on reduced skeletal
muscle tone (males and females) and decreased body weight gain
(females).  The NOAEL is 180 ppm (14 mg/kg/day).

This 90-day oral toxicity study in the rat is Acceptable/Guideline and
does satisfy the guideline requirement for a 90-day oral toxicity study
in rodents (OPPTS 870.3100; OECD 408).

Chronic Toxicity/Carcinogenicity (Rat)

In a combined chronic toxicity/carcinogenicity study (MRID 42940202,
44052901), 2,6-dichlorobenzamide (dichlobenil soil metabolite) (99.5%;
batch# 195) was administered in the diet for 106 weeks to Crl:CD®BR
rats (35/sex/dose) at daily dose levels of 0, 60, 100, 180, or 500 ppm
(equal to 0, 2.2, 3.6, 6.5, or 19 mg/kg/day in males and 0, 2.8, 4.7,
8.5, or 25 mg/kg/day in females).  No treatment-related mortality or
clinical signs of toxicity were observed.

Body weight, relative to controls, at 500 ppm was decreased by 13%
(P<0.05) in males at termination and by 10-21% in females from week 13
until the end of the study.  At 180 ppm, body weight in females was
decreased by 13% at termination only.  At 500 ppm, mean body weight gain
was decreased by 10-16% in males and by 16-26% in females from on or
after week 26.  Body weight gain in females treated at 180 ppm was also
decreased by 10-17% during the second half of the study.  No
treatment-related differences in food consumption or food efficiency
were observed during the study.  Ophthalmological findings were similar
between the control and high-dose groups.

Mean hematocrit levels were decreased in males at 500 ppm by 4% (week
39) and 11% (week 103).  Decreases were also observed in females at 180
ppm (9%, week 26) and at 500 ppm (7%, week 52).  Mean hemoglobin
concentration (Hb) was decreased by 3% (week 26), 8% (week 39), 7% (week
52), and 9% (week 103) at 500 ppm.  A decrease (6%) in females was
observed at 180 ppm during week 26 only.  Mean erythrocyte counts were
decreased in males at 180 ppm (6%, week 40) and at 500 ppm (9%, week 26;
7%, week 39).  In females, the same parameter was decreased at 500 ppm
by 5% (week 26).  Last, mean corpuscular hemoglobin concentration was
also decreased by 3% at 500 ppm in females at week 103.  Although
statistically significant, the magnitude of change in the hematological
parameters was not biologically significant.  No treatment-related
changes were observed in clinical chemistry or urinalysis measurements.

A 25% increases in mean relative liver weight was observed at 500 ppm in
females, as was a 48% increase in mean relative adrenal weight.  The
increase in liver weight was considered toxicologically significant due
to the presence of liver histopathology at 500 ppm.  No
treatment-related changes were observed at necropsy.

Non-neoplastic histopathological observations in the liver are
summarized in Tables 1 and 2.  Dose-dependence was lacking for several
parameters measured in the liver (Table 1).  An increase in
“moderate” fat deposition was observed at 500 ppm in females (14/35
vs. 6/26); however, the incidence of “marked” fat deposition (more
severe) was higher at 60 ppm than at 500 ppm.  In addition, the reported
incidences of fat deposition are unreliable, because the sum of the
number of animals with and without fat deposition at each dose is less
than the number of animals examined per dose.  Upon reanalysis of
non-neoplastic liver findings (MRID 44043601), increases in the
incidences of eosinophilic (focal) hepatocytes (21/34 vs. 5/26; P<0.01)
and centrilobular hepatocytic vacuolation (16/34 vs. 5/26; P<0.05) were
observed in males at 500 ppm (Table 2).  The increase in eosinophilic
(focal) staining hepatocytes at 100 ppm (P<0.01) was not considered
toxicologically significant, since the incidence at the next highest
dose (180 ppm) was not statistically significant.  In females, an
increase in the incidence of eosinophilic hepatocytes (focal) was
observed at 180 ppm (16/32 vs. 5/25; P<0.05) and 500 ppm (23/35 vs.
5/25; P<0.01).  Increases were also observed at 500 ppm in the
incidences of focal basophilic hepatocytes (23/35 vs. 9/25; P<0.05) and
eosinophilic (diffuse) hepatocytes (18/35 vs. 2/25; P<0.01).  No
treatment-related histopathological effects were observed in any other
examined organ.

The LOAEL is 500 ppm (19 mg/kg/day) in males, based on decreased body
weight and body weight gain and an increased incidence of hepatocellular
alteration (eosinophilic foci); and 180 ppm (8.5 mg/kg/day) in females,
based on decreased body weight and body weight gain and an increased
incidence of hepatocellular alteration (eosinophilic foci).  The NOAEL
is 180 ppm (6.5 mg/kg/day) in males and 100 ppm (4.7 mg/kg/day) in
females.

Upon re-analysis of the tumor data (MRID 44043601), a marginally
significant increase (P=0.049) in the incidence of hepatocellular
adenomas was observed in females at 500 ppm (Table 3).  No
hepatocellular carcinomas were observed in female rats, and neither
adenomas nor carcinomas were observed in males.  Dosing was considered
adequate at 500 ppm, based on decreased body weight and body weight gain
and increased incidence of hepatocellular alteration in both sexes.

This combined chronic toxicity/carcinogenicity study in the rat is
Acceptable/Guideline and does satisfy the guideline requirement for a
combined chronic toxicity/carcinogenicity study in mammals [OPPTS
870.4300; OECD 453].

2-year dog

In a 2-year toxicity study (MRID 42940203), 2, 6-dichlorobenzamide
(dichlobenil soil metabolite) (97% a.i.; batch # 133-2-4-104) was
administered in the diet to Beagle dogs (4/sex/dose) at daily dose
levels of 0, 60, 100, 180, or 500 ppm (equal to 0, 1.5, 2.5, 4.5, or
12.5 mg/kg/day).  No animals died during the study, and it was reported
that there were no treatment-related clinical signs of toxicity.  Mean
body weight in males treated at 500 ppm was decreased (non-stat. sig.)
at weeks 54 (14%) and 103 (12%), while in females mean body weight was
decreased (P<0.01) at weeks 14 (12%), 54 (21%), and 103 (23%) at 500
ppm, relative to controls.  Mean cumulative body weight gains (week
0-103) in males were 19% and 38% lower than control values at 180 and
500 ppm, resp.  However, neither was statistically significantly
different from controls (Table 1).  Similarly, in females, mean
cumulative body weight gains at 100, 180, and 500 ppm were 27%, 32%, and
69% lower than control values, respectively, without statistical
significance.  Changes in body weight or body weight gain at ≤180 ppm
were not considered toxicologically significant based on the wide
variation in these measured parameters (Tables 1 and 2).  No adverse
effects were observed on hematological or clinical chemistry parameters,
at necropsy, or on organ weights.  Microscopic pathology was not
observed as a function of dose.

The LOAEL is 500 ppm (12.5 mg/kg/day), based on decreased body weight
and body weight gain.  The NOAEL is 180 ppm (4.5 mg/kg/day).

This chronic toxicity study in the dog is Acceptable/Guideline and does
satisfy the guideline requirement for a chronic toxicity study in
non-rodents (OPPTS 870.4100; OECD 452).

3-gen. repro. (rat)

The following executive summary provides an overview of the submitted
results of a 3-generation reproduction study (MRID 42940204), but for
which individual animal data were not submitted.  BAM
(2,6-dichlorobenzamide; 99.5% a.i.; batch # 195) was administered in the
diet to Long-Evans rats (10 males/dose and 20 females/dose in the P, F1,
and F2 generations) at daily dose levels of 0, 60, 100, or 180 ppm
(equivalent to 0, 4.5, 7.5, or 13.5 mg/kg/day) for 3 consecutive
generations.  Two litters were produced in each generation.  The number
of pups per litter was counted on postnatal days (PNDs) 1, 5, and 21
(also weighed).  Litters were culled to ten animals each on PND 5.  P,
F1, and F2 generation parental animals were weighed and examined for
gross pathology on the day of termination (unspecified).  Organ weights
were measured, and histopathology was performed on select F3b weanlings
only.

No treatment-related mortality was observed in the P, F1b, or F2b
parental generations.  A 6% (P<0.05) decrease in mean parental terminal
body weight was observed at 180 ppm in the F2b generation; however, the
decrease was not biologically significant and not observed in P or F1b
parental animals.  No treatment-related gross pathology was observed in
P, F1b, or F2b parental animals.  Fertility and gestation indices were
similar across treatment groups in P, F1, and F2 generation dams.

The parental systemic LOAEL was not observed.  The parental systemic
NOAEL is 180 ppm (13.5 mg/kg bw/day).

The reproductive LOAEL was not observed.  The reproductive NOAEL is 180
ppm (13.5 mg/kg bw/day).

No treatment-related differences were observed in the mean number of
pups per litter on PNDs 1, 5 (pre-cull), or 21 in the F1, F2 or F3
generations.  Viability and lactation indices were similar across the
treatment groups in F1, F2, and F3 generation pups.  Mean survival from
birth to PND 5 (viability index) was slightly reduced (86.2%, P<0.01;
vs. 95.7% in controls) at 180 ppm in the F3b generation; however this
decrease was not observed in any other generation.  In addition, mean
survival from birth to weaning was similar across dose for each of the
three generations of offspring.  Hyperexcitability was observed in pups
(number not reported) from four litters in the F1b generation only.

Mean weanling weights (calculated as entire litter weight divided by
number of pups per litter) at 180 ppm were decreased by 15% (P<0.05),
12% (P<0.05), and 14% (P<0.01) in the F1b, F3a, and F3b generations,
respectively (Table 1); however, the decreases were not dose-dependent,
not observed in the F2 generation, and not calculated from individual
pup body weights.  No treatment-related differences were observed in
mean absolute brain weights or mean brain-to-body weight ratios in F3b
generation weanling rats of either sex.  A 12% increase in mean absolute
kidney weights and mean kidney-to-body weight ratios (P<0.01) was
observed in F3b generation female weanlings at 180 ppm.  A 10% increase
in mean absolute liver weights and mean liver-to-body weight ratios
(P<0.05) in males at 180 ppm and at ≥100 ppm in females was observed
in this same generation. Changes in F3b generation weanling mean organ
weights were not considered toxicologically significant, however, due to
a lack of histopathological correlates in the liver and kidney.

The offspring LOAEL was not observed.  The offspring NOAEL is 180 ppm
(13.5 mg/kg bw/day).

This study in the rat is Unacceptable/Guideline and does not satisfy the
guideline requirement for a 2-generation reproduction study in mammals
(OPPTS 870.3800; OECD 416).  Individual animal data necessary to verify
summary results were not

submitted.

Developmental tox (rabbit)

In a prenatal developmental toxicity study (MRID 43003601, 43265201),
2,6-dichlorobenzamide  (dichlobenil soil metabolite) (99.4% a.i.; batch#
FUX001000) was administered by gavage in 1% gum tragacanth to 16
pregnant New Zealand white rabbits/sex/dose from gestation day (GD) 7-19
inclusive at daily dose levels of 0, 10, 30, or 90 mg/kg/day.  Five (of
16) females treated at 90 mg/kg/day were sacrificed in extremis.  Three
of the 5 sacrificed high-dose dams had late abortions (GD 19, 21, and
22, resp.). The incidence of abortion followed by sacrifice at 0, 10,
and 30 mg/kg/day was 1/16, 1/16, and 0/16, respectively.  The other 2/5
high-dose animals were sacrificed moribund.  Moribund condition followed
by sacrifice was observed in 1/16, 0/16, and 2/16 animals at 0, 10, and
30 mg/kg/day, resp.  The incidence of thin appearance was increased at
90 mg/kg/day (10/16), whereas the incidences at 0, 10, and 30 mg/kg/day
were 1/16, 0/16, and 2/16, respectively.

A decrease (129%) in mean body weight gain, relative to controls, was
observed during the dosing period (GD 7-19) in does treated at 90
mg/kg/day.  Similarly, food consumption at 90 mg/kg/day was decreased
during the dosing period by 49%, relative to controls.  Body weight gain
and food consumption in high-dose animals rebounded above control levels
during the post-dosing period (GD 20-28).  No treatment-related gross
pathology was observed.

The maternal LOAEL is 90 mg/kg bw/day, based on increased incidences of
clinical signs (late abortion, thin appearance) and decreased (severe)
body weight gain and food consumption during dosing.  The maternal NOAEL
is 30 mg/kg bw/day.

No treatment-related effects were observed on several developmental
endpoints, including the number of resorptions, post-implantation loss,
litter size, and sex ratio.  Mean fetal body weight at 90 mg/kg bw/day
(33.9 g) was decreased by 6%, relative to controls; however, the change
was not statistically significant and the mean value fell within the
historical control range (27.7 g-39.4 g).  No treatment-related changes
were observed on the incidences of external defects.

An increase in the incidence of bipartite interparietal bone was
observed at 90 mg/kg bw/day.  Litter incidences were 1/14, 1/15, 2/14,
and 3/11 litters at 0, 10, 30, and 90 mg/kg/day.  Bipartite
interparietal bone is considered a malformation in rats.  Historical
control data were not provided for the litter incidences of bipartite
interparietal bone, and fetal incidences only were reported for the
current study.  However, the fetal incidences were not statistically
significant different from concurrent controls, and the concurrent
control fetal incidence (0.8%) exceeded that of the historical controls
(0.3%).  An increase in the incidence of postcaval lung lobe agenesis
was also observed at 90 mg/kg bw/day.  Litter incidences were 0/14,
0/15, 1/14, and 3/11 at 0, 10, 30, and 90 mg/kg/day.  The fetal
incidence of postcaval lung lobe agenesis at 90 mg/kg bw/day (3.2%)
exceeded that of the historical controls (1.2%), whereas that at 30
mg/kg bw/day (0.9%) did not.

The developmental LOAEL is 90 mg/kg bw/day, based on increased
incidences of late abortion and skeletal (bipartite interparietal bone)
and visceral (postcaval lung lobe agenesis) anomalies.  The
developmental NOAEL is 30 mg/kg bw/day.

This study in the rabbit is Acceptable/Guideline and does satisfy the
guideline requirement for a prenatal developmental toxicity study in
non-rodents (OPPTS 870.3700; OECD  414).

Acute (i.p.) (mouse)

The toxic effects of the herbicide chlorthiamid
(2,6-dichlorothiobenzamide) and its major environmental metabolite
2,6-dichlorobenzamide (DCBA) were examined in the nasal passages of
C57Bl mice following single ip injections. Chlorthiamid (12.25, and 50
mg/kg) induced an extensive destruction of the olfactory region, similar
to that previously observed with the analogue dichlobenil
(2,6-dichlorobenzonitrile). Necrosis of Bowman's glands was evident
first, whereas degeneration and necrosis of the olfactory
neuroepithelium developed less rapidly. The lesions were most severe in
the dorsomedial region of the nasal cavity. At longer post-treatment
intervals, the olfactory epithelium was replaced by a respiratory-like
epithelium, and there was fibrosis of the lamina propria. DCBA was also
toxic to the olfactory region (100 mg/kg), inducing necrosis of the
Bowman's glands and the neuroepithelium in the dorsomedial region of the
nasal cavity. No lesions were observed in other parts of the nasal
cavity or in the liver after administration of chlorthiamid or DCBA.
Chlorthiamid (IC50 = 51 microM), but not DCBA, inhibited the covalent
binding of 14C-labeled dichlobenil in the olfactory mucosa in vitro. It
is proposed that the toxic effects of chlorthiamid and dichlobenil in
the olfactory mucosa are mediated by common or closely related
metabolites.

Genotoxicity

870.5100

g/plate (-/+ activation) in S. typhimurium

Acceptable/Guideline

Negative with or without activation.

870.5395

In vivo mouse erythrocyte micronucleus assay

43003602 (1993), 43747101 (1995)

0, 250 mg/kg

Acceptable/Guideline

Negative.

Lethargy observed in dose-range finding (pilot) study at 100 mg/kg/day
(=LOAEL; NOAEL not observed)

870.5550

In vitro Unscheduled DNA synthesis (rat hepatocytes)

43003604 (1993)

At concentrations up to 1000 g/ml

Acceptable/Guideline

Negative.

Dichlobenil

5-day dermal (mouse)

2,6-Dichlorobenzonitrile (dichlobenil) is an herbicide which has
previously been reported by other investigators to be toxic to the
olfactory mucosa following intraperitoneal administration. The objective
of this study was to determine whether a more occupationally-relevant
route of pesticide exposure, namely dermal exposure to dichlobenil, also
resulted in olfactory system damage. Male C57Bl mice were clipped and
administered 0-200 mg/kg dichlobenil dermally in acetone either as a
single dose or for five consecutive days. In addition, olfactory bulb
glial fibrillary acidic protein (GFAP) analysis was performed in order
to determine whether the damage in the olfactory mucosa translated into
damage which could be measured as an astroglial increase in GFAP
concentration in the olfactory bulb, a marker of central nervous system
neuronal loss. Olfactory mucosal histology revealed that single or
multiple exposures to 50, 100, 150 and 200 mg/kg dichlobenil dermally
caused olfactory epithelial damage (primarily sensory cell loss) in the
epithelium lining the dorsal medial meatus of the nasal cavity. While
the olfactory epithelial lesions were much less severe than those caused
by i.p. administration of dichlobenil, GFAP was significantly elevated
in both the 150 and 200 mg/kg treatment groups, demonstrating that
relatively minor damage to a portion of the olfactory mucosa in the
nasal cavity can be detected in the central nervous system.

7/28-day inhalation (rat)

In a subchronic inhalation toxicity study (MRID 46398701),
Sprague-Dawley rats (10/sex/concentration) were exposed by nose-only
inhalation to Dichlobenil technical (98.1% a.i., Lot/Batch #: BFI-4138)
as a dust aerosol at concentrations of 0, 2.3, 5.1, or 12 mg/m3
(equivalent to 0, 0.0023, 0.0051, and 0.012 mg/L, respectively) for 6
hours/day, 5 days/week for 4 weeks.

There were no treatment-related effects on survival, clinical
observations, FOB, motor activity, body weights, body weight gains, food
consumption, ophthalmoscopy, hematology, clinical chemistry, organ
weights, gross pathology, or histopathology in either sex at any
concentration.

The LOAEL was not observed in this study, and the investigators did not
test to the limit concentration (2 mg/L).  However, the 7-day
range-finding study (MRID 46653001) indicated that toxicity occurred at
21 mg/m3 based on trace to mild nasal degeneration in males and females.
The nasal effects are considered adverse rather than adaptive since the
nasal tissue has been determined to be a target by routes of exposure
other than inhalation.

The LOAEL is 21 mg/m3 (equivalent to 5.5 mg/kg/day) based on increased
incidence of nasal degeneration (from the 7 day study).  The NOAEL is 12
mg/m3 (equivalent to 3.1 mg/kg/day), the highest concentration tested.

At the request of the Agency, this study was conducted for a duration of
28 days, instead of the 90 days required by Guideline OPPTS 870.3465.
Aside from the different study duration, this study was conducted in
accordance with Guideline OPPTS 870.3465.

This 28-day study is classified as Acceptable/Guideline and does satisfy
the guideline requirement (OPPTS 870.3465; OECD 413) for a subchronic
inhalation study in the rat.

Appendix B:  Metabolism Assessment  TC \l1 "Appendix B:  Metabolism
Assessment

B.1	Metabolism Guidance and Considerations TC \l2 "B.1	Metabolism
Guidance and Considerations

BAM is a metabolite and/or environmental degradate of both fluopicolide
and dichlobenil.

BAM is included in the tolerance expression for dichlobenil because it
is a major metabolite/degradate of dichlobenil.

BAM is a minor metabolite of fluopicolide.  The tolerance expression for
plants will include fluopicolide (parent) as an indicator of combined
residues of fluopicolide and BAM.  HED determined that BAM should be
included as a residue of concern for the risk assessment for the
proposed uses of fluopicolide on the primary domestic plants [cucurbit
vegetables, fruiting vegetables, grapes, leafy vegetables, and tuberous
and corm vegetables (except potato)].

Based on two aerobic soil metabolism studies, fluopicolide (parent) and
BAM are the residues of concern in drinking water.  BAM was a major
metabolite of fluopicolide in these aerobic soil metabolism studies,
present at levels up to 40%.

B.2	Chemical Names and Structures  TC \l2 "B.2	Chemical Names and
Structures

Appendix I.  Chemical Names and Structures

Common name/code	Chemical name	Chemical structure

Dichlobenil	2,6-dichlorobenzonitrile

Fluopicolide

AE C638206
2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl-2-pyridinyl]methyl]benzamid
e

AE C653711

BAM	2,6-dichlorobenzamide

AE C657188

PCA	3-chloro-5-trifluoromethylpyridine-2-carboxylic acid

AE 1344122

P1X	3-methylsulfinyl-5-trifluoromethylpyridine-2-carboxylic acid

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on data from studies in which adult human subjects were intentionally
exposed to a pesticide or other chemical.  These studies, listed below,
have been determined to require a review of their ethical conduct.  They
are also subject to review by the Human Studies Review Board.  The
listed studies have received the appropriate review.

The PHED Task Force, 1995.  The Pesticide Handlers Exposure Database,
Version 1.1.  Task Force members Health Canada, U.S. Environmental
Protection Agency, and the National Agricultural Chemicals Association,
released February, 1995.

   HYPERLINK
"http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo
l=pubmed_Abstract&term=%22Solecki+R%22%5BAuthor%5D" \o "Click to search
for citations by this author."  Solecki R ,   HYPERLINK
"http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo
l=pubmed_Abstract&term=%22Burgin+H%22%5BAuthor%5D" \o "Click to search
for citations by this author."  Burgin H ,   HYPERLINK
"http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo
l=pubmed_Abstract&term=%22Buschmann+J%22%5BAuthor%5D" \o "Click to
search for citations by this author."  Buschmann J  et al. 2001.
Harmonisation of rat fetal skeletal terminology and classification.
Report of the Third Workshop on the Terminology in Developmental
Toxicology. Berlin, 14-16 September 2000.   HYPERLINK
"javascript:AL_get(this,%20'jour',%20'Reprod%20Toxicol.');"  Reprod
Toxicol  15(6):713-21.

 Calculated as follows: Dose (mg/kg bw/day) = (Concentration of a.i. in
ppm) x (1 ppm ÷ 0.075 mg/kg bw/day)

   HYPERLINK
"http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo
l=pubmed_Abstract&term=%22Solecki+R%22%5BAuthor%5D" \o "Click to search
for citations by this author."  Solecki R ,   HYPERLINK
"http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo
l=pubmed_Abstract&term=%22Burgin+H%22%5BAuthor%5D" \o "Click to search
for citations by this author."  Burgin H ,   HYPERLINK
"http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo
l=pubmed_Abstract&term=%22Buschmann+J%22%5BAuthor%5D" \o "Click to
search for citations by this author."  Buschmann J  et al. 2001.
Harmonisation of rat fetal skeletal terminology and classification.
Report of the Third Workshop on the Terminology in Developmental
Toxicology. Berlin, 14-16 September 2000.   HYPERLINK
"javascript:AL_get(this,%20'jour',%20'Reprod%20Toxicol.');"  Reprod
Toxicol  15(6):713-21.

   HYPERLINK
"http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&T
ermToSearch=1916084&ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubm
ed_ResultsPanel.Pubmed_RVDocSum"  Brittebo EB, Eriksson C, Feil V, Bakke
J, Brandt I.  (1991). Toxicity of 2,6-dichlorothiobenzamide
(chlorthiamid) and 2,6-dichlorobenzamide in the olfactory nasal mucosa
of mice. Fundam Appl Toxicol 17(1):92-102.

   HYPERLINK
"http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo
l=pubmed_Abstract&term=%22Deamer+NJ%22%5BAuthor%5D"  Deamer NJ ,
HYPERLINK
"http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo
l=pubmed_Abstract&term=%22O%27Callaghan+JP%22%5BAuthor%5D"  O'Callaghan
JP ,   HYPERLINK
"http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo
l=pubmed_Abstract&term=%22Genter+MB%22%5BAuthor%5D"  Genter MB . (1994).
Olfactory toxicity resulting from dermal application of
2,6-dichlorobenzonitrile (dichlobenil) in the C57Bl mouse.
Neurotoxicology 15(2):287-93.

 of    NUMPAGES \* arabic \* MERGEFORMAT  66

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[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Rules and Regulations]
[Pages 36285-36286]
[FR Doc No: 2011-15305]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0116; Airspace Docket No. 11-ANE-1]

Establishment of Class E Airspace; Brunswick, ME

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action establishes Class E Airspace at Brunswick, ME, to
accommodate the additional airspace needed for the Standard Instrument
Approach Procedures developed for Brunswick Executive Airport. This
enhances the safety and airspace management of Instrument Flight Rules
(IFR) operations at the airport. This action also corrects errors in
the legal description published as a proposed rule in the Federal
Register on March 18, 2011.

DATES: Effective 0901 UTC, August 25, 2011. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On March 18, 2011, the FAA published in the Federal Register a
notice of proposed rulemaking to establish Class E airspace at
Brunswick Executive Airport, Brunswick, ME (75 FR 14824) Docket No.
FAA-2011-0116. Interested parties were invited to participate in this
rulemaking effort by submitting written comments on the proposal to the
FAA. No comments were received. Subsequent to publication, a
typographical error was found in the controlled airspace radius
mileage. This action will make the correction.

    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9U dated August 18, 2010, and effective September 15,
2010, which is incorporated by reference in 14 CFR Part 71.1. The Class
E airspace designations listed in this document will be published
subsequently in the Order.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 establishes Class E airspace extending upward from 700 feet
above the surface at Brunswick, ME to provide controlled airspace
required to support the standard instrument approach procedures
developed for Brunswick Executive Airport. This action is necessary for
the safety and management of IFR operations at the airport. Brunswick
Executive Airport uses the same facilities as the former Brunswick
Naval Air Station (NAS), which closed in September 2010 (see 75 FR
57848).
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes Class E airspace at Brunswick, ME.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9U, Airspace Designations and Reporting
Points, dated August 18, 2010, effective September 15, 2010, is amended
as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANE ME E5 Brunswick, ME [New]

Brunswick Executive Airport, ME
    (Lat. 43[deg]53'32''N., long. 69[deg]56'19'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.7-mile radius of Brunswick Executive Airport.

    Issued in College Park, Georgia, on June 2, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2011-15305 Filed 6-21-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 226 (Monday, November 29, 2021)]
[Notices]
[Pages 67704-67706]
[FR Doc No: 2021-25940]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2290-122]

Southern California Edison Company; Notice of Intent To File
License Application, Filing of Pre Application Document (Pad),
Commencement of Pre Filing Process, and Scoping; Request for Comments
on the Pad and Scoping Document, and Identification of Issues and
Associated Study Requests

    a. Type of Filing: Notice of Intent to File License Application for
a New License and Commencing Pre-filing Process.
    b. Project No.: 2290-122.
    c. Dated Filed: September 22, 2021.
    d. Submitted By: Southern California Edison Company (SCE).
    e. Name of Project: Kern River No. 3 Hydroelectric Project (Kern 3
Project).
    f. Location: The project is located on the North Fork Kern River
and on Salmon and Corral Creeks in Kern and Tulare Counties,
California. The existing FERC project boundary encompasses a total of
234.6 acres of land, consisting of 9.4 acres of land owned by SCE and
225.2 acres of federal land in Sequoia National Forest administered by
the U.S. Forest Service.
    g. Filed Pursuant to: 18 CFR part 5 of the Commission's
Regulations.
    h. Potential Applicant Contact: Martin Ostendorf, Senior Manager,
Southern California Edison Company, 1515 Walnut Grove Avenue, Rosemead,
CA 91770;<PHONE_NUMBER>; [email protected].
    i. FERC Contact: Quinn Emmering at<PHONE_NUMBER> or email at
[email protected].
    j. Cooperating Agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item o below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See 94 FERC ]
61,076 (2001).
    k. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service and/or the National Oceanic and
Atmospheric Administration Fisheries under section 7 of the Endangered
Species Act and the joint agency regulations thereunder at 50 CFR part
402 and (b) the State

Historic Preservation Office, as required by section 106, National
Historic Preservation Act, and the implementing regulations of the
Advisory Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating SCE as the Commission's
non-federal representative for carrying out informal consultation,
pursuant to section 7 of the Endangered Species Act and section 106 of
the National Historic Preservation Act.
    m. SCE filed with the Commission a Pre-Application Document (PAD),
including a proposed process plan and schedule, pursuant to 18 CFR 5.6
of the Commission's regulations.
    n. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents via the internet through
the Commission's Home Page (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. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Register online at https://ferconline.ferc.gov/FERCOnline.aspx to
be notified via email of new filing and issuances related to this or
other pending projects. For assistance, contact FERC Online Support.
    o. With this notice, we are soliciting comments on the PAD and
Commission staff's Scoping Document 1 (SD1), as well as study requests.
All comments on the PAD and SD1, and study requests should be sent to
the address above in paragraph h. In addition, all comments on the PAD
and SD1, study requests, requests for cooperating agency status, and
all communications to and from staff related to the merits of the
potential application must be filed with the Commission.
    The Commission strongly encourages electronic filing. Please file
all documents using the Commission's eFiling system at https://ferconline.ferc.gov/FERC.aspx. Commenters can submit brief comments up
to 6,000 characters, without prior registration, using the eComment
system at https://ferconline.gov/QuickComment.aspx. You must include
your name and contact information at the end of your comments. For
assistance, please contact FERC Support at [email protected]
In lieu of electronic filing, you may submit a paper copy. Submissions
sent via the U.S. Postal Service must be addressed to: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street
NE, Room 1A, Washington, DC 20426. Submissions sent via any other
carrier must be addressed to: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852. The first page of any filing should include docket number P-
2290-122.
    All filings with the Commission must bear the appropriate heading:
``Comments on Pre-Application Document,'' ``Study Requests,''
``Comments on Scoping Document 1,'' ``Request for Cooperating Agency
Status,'' or ``Communications to and from Commission Staff.'' Any
individual or entity interested in submitting study requests,
commenting on the PAD or SD1, and any agency requesting cooperating
status must do so by January 20, 2022.
    p. The Commission's scoping process will help determine the
required level of analysis and satisfy the National Environmental
Policy Act (NEPA) scoping requirements, irrespective of whether the
Commission prepares an environmental assessment or environmental impact
statement.

Scoping Meetings

    Due to on-going concerns with large gatherings related to COVID-19,
we do not intend to hold in-person public scoping meetings or an in-
person environmental site review. Rather, Commission staff will hold
two public scoping meetings using a telephone conference line. The
daytime scoping meeting will focus on resource agency, Indian tribes,
and non-governmental organization (NGO) concerns, while the evening
scoping meeting will focus on receiving input from the public. We
invite all interested agencies, Native American tribes, NGOs, and
individuals to attend one of these meetings to assist us in identifying
the scope of environmental issues that should be analyzed in the NEPA
document. Additionally, a virtual site tour of the Kern 3 Project is
available on SCE's website. The dates and times of the meetings as well
as how to access the virtual site tour are listed below.

Virtual site tour of the project: Access online at: www.sce.com/regulatory/hydro-licensing/kr3.
Meeting for resource agencies, Tribes, and NGOs: Tuesday, December 14,
2021, 9:00 a.m.-12:00 p.m. PST. Call in number:<PHONE_NUMBER>. Access
code: 2762 739 2357. When prompted for attendee ID: Press #.
Meeting for the general public: Tuesday, December 14, 2021, 6:00 p.m.-
8:00 p.m. PST. Call in number:<PHONE_NUMBER>. Access code: 2762 506
0330. When prompted for attendee ID: Press #.

    SD1, which outlines the subject areas to be addressed in the
environmental document, was mailed to the individuals and entities on
the Commission's mailing list and SCE's distribution list. Copies of
SD1 may be viewed on the web at http://www.ferc.gov, using the
``eLibrary'' link. Follow the directions for accessing information in
paragraph n. Based on all oral and written comments, a Scoping Document
2 (SD2) may be issued. SD2 may include a revised process plan and
schedule, as well as a list of issues, identified through the scoping
process.

Meeting Objectives

    At the scoping meetings, Commission staff will: (1) Initiate
scoping of the issues; (2) review and discuss existing conditions; (3)
review and discuss existing information and identify preliminary
information and study needs; (4) review and discuss the process plan
and schedule for pre-filing activity that incorporates the time frames
provided for in Part 5 of the Commission's regulations and, to the
extent possible, maximizes coordination of federal, state, and tribal
permitting and certification processes; and (5) discuss the potential
of any federal or state agency or Indian tribe to act as a cooperating
agency for development of an environmental document. Meeting
participants should come prepared to discuss their issues and/or
concerns. Please review the PAD in preparation for the scoping
meetings. Directions on how to obtain a copy of the PAD and SD1 are
included in item n of this document.

Meeting Procedures

    Commission staff will be moderating the scoping meetings. The
meetings will begin promptly at their respective start times listed
above. After calling the phone number listed above, enter the correct
access code and when prompted to enter the attendee ID press the `#'
button (no ID number is required). All participants will be
automatically muted upon joining the meeting.
    At the start of the meeting, staff will provide further
instructions regarding the meeting setup, agenda, and time period for
comments and questions. We ask for your patience as staff present
information and field participant

comments in orderly manner. To indicate you have a question or comment,
press * and 3 to virtually ``raise your hand''. Oral comments will be
limited to 5 minutes in duration for each participant. The meetings
will be recorded by a stenographer and will be filed to the public
record of the project.
    Please note, that if no participants join the meetings within 15
minutes after the start time, staff will end the meeting and conference
call. The meetings will end after participants have presented their
oral comments or at the specified end time, whichever occurs first.

    Dated: November 22, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-25940 Filed 11-26-21; 8:45 am]
BILLING CODE 6717-01-P


  SEQ CHAPTER \h \r 1  	ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R03-OAR-2006-0682; FRL-       ]

Approval and Promulgation of Air Quality Implementation Plans; West
Virginia; Redesignation of the West Virginia Portion of the Wheeling,
WV-OH 8-Hour Ozone Nonattainment Area to Attainment and Approval of the
Area’s Maintenance Plan

AGENCY:	Environmental Protection Agency (EPA).

ACTION:	Final rule.

SUMMARY:  EPA is approving a redesignation request and a State
Implementation Plan (SIP) revision submitted by the State of West
Virginia.  The West Virginia Department of Environmental Protection
(WVDEP) is requesting that the Marshall and Ohio County, West Virginia
(Wheeling) portion of the Wheeling, WV-OH area (herein referred to as
the “Area”) be redesignated as attainment for the 8-hour ozone
national ambient air quality standard (NAAQS).  In conjunction with its
redesignation request, the State submitted a SIP revision consisting of
a maintenance plan for Wheeling that provides for continued attainment
of the 8-hour ozone NAAQS for the next 12 years, until 2018.  EPA is
also approving the adequacy determination for the motor vehicle emission
budgets (MVEBs) that are identified in the Wheeling 8-hour ozone
maintenance plan for purposes of transportation conformity, and is
approving those MVEBs.  EPA is approving the redesignation request and
the maintenance plan revision to the West Virginia SIP in accordance
with the requirements of the CAA.

EFFECTIVE DATE:  This final rule is effective on [insert date 30 days
from date of publication].

ADDRESSES:  EPA has established a docket for this action under Docket ID
Number EPA- R03-OAR-2006-0682.  All documents in the docket are listed
in the     HYPERLINK "http://www.regulations.gov"  www.regulations.gov
website.  Although listed in the electronic docket, some information is
not publicly available, i.e., confidential business information (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
through     HYPERLINK "http://www.regulations.gov"  www.regulations.gov
or in hard copy for public inspection during normal business hours at
the Air Protection Division, U.S. Environmental Protection Agency,
Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.  Copies
of the State submittal are available at the West Virginia Department of
Environmental Protection, Division of Air Quality, 601 57th Street SE,
Charleston, WV 25304.

FOR FURTHER INFORMATION CONTACT:  Amy Caprio,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:

I.  Background

On October 2, 2006 (71 FR 57894), EPA published a notice of proposed
rulemaking (NPR) for the State of West Virginia.  The NPR proposed
approval of West Virginia’s redesignation request and a SIP revision
that establishes a maintenance plan for Wheeling that sets forth how
Wheeling will maintain attainment of the 8-hour ozone NAAQS for the next
12 years.  The formal SIP revision was submitted by the WVDEP on July
24, 2006.  Other specific requirements of West Virginia’s
redesignation request SIP revision for the maintenance plan and the
rationales for EPA’s proposed actions are explained in the NPR and
will not be restated here.

On October 20, 2006, EPA received a comment, from the West Virginia
Division of Highways, in support of its October 2, 2006 NPR.  Also, on
October 28, 2006, EPA received adverse comments on the said October 2,
2006 NPR.  A summary of the comments submitted and EPA’s responses are
provided in Section II of this document.

  SEQ CHAPTER \h \r 1 II.  Summary of Public Comments and EPA Responses

Comment:  The commenter stated that on behalf of the West Virginia
Division of Highways, they would like to go on record as supporting the
redesignation of the Wheeling, West Virginia portion of the Wheeling,
WV-OH interstate area from nonattainment to attainment.

Response:  EPA acknowledges the comment of support for our final action.

Comment:  The commenter states that the Wheeling Area redesignation is
based on 2002-2004 air quality data, and should instead be based on the
most recent three years of air quality data, 2004-2006.

Response:  EPA disagrees that the 2006 data was available as a basis for
redesignating Wheeling to attainment, and also disagrees with the
comment that the redesignation cannot be based on the quality assured
2002-2004 air quality data.  EPA may redesignate an area to attainment
of the 8-hour ozone NAAQS if three years of quality assured data
indicate that the area has attained the standard and the most recent
quality assured air quality data indicates that the area is still
attaining the standard at the time of the redesignation.  EPA has
determined that the Wheeling, WV portion of the Wheeling, WV-OH
nonattainment area has attained compliance with the 8-hour ozone NAAQS
subsequent to the calendar year 2004 ozone season (April –October)
based on three years (2002-2004) of quality assured data.  It is also
worth noting that while our determination that the Area has attained the
standard is based on the 2002-2004 data, the 2005 calendar year quality
assured data and the newly available quality assured data from 2006,
indicate that the Area continues to attain the standard.  The 2005 and
2006 data support our conclusion in the notice of proposed rulemaking
(NPR) on October 2, 2006 (71 FR 57894) that emissions reductions in the
Area can be contributed to permanent and enforceable measures throughout
the Area and that air quality monitoring date indicates that the Area
continues to attain the 8-hour ozone NAAQS.

Comment:  The commenter asserts that EPA should not approve the
redesignation of Wheeling because the Wheeling monitor was twice
relocated during calendar years 2004 and 2005.  The commenter states
that (at its current location) the Wheeling ozone monitor should operate
for one additional year in order to confirm attainment of the NAAQS and
that EPA should not act on WVDEP’s redesignation request until the air
quality data for the additional monitoring period has been evaluated.

Response:  Since 1982, WVDEP has operated and maintained an ozone
monitoring station for the West Virginia portion of the Wheeling Area.
The commenter refers to the Wheeling monitor as having been relocated
from “Site 7” to “Site 9,” and finally to “Site 10.”  The
monitoring station was originally located at WVDEP’s Northern
Panhandle Regional Office.  The station continued to operate at this
location (Site 7) until WVDEP had to discontinue the operations at the
site due to the relocation of its Northern Panhandle Regional Office
prior to the calendar year 2004 ozone season (April through October).
As a result, WVDEP installed an interim ozone station in the Wheeling
Area which was located approximately four miles south of the station’s
original location and collected data for the 2004 ozone season (Site 9).
 In anticipation of the 2005 season, WVDEP established a new site for
the Wheeling ozone monitor which was approximately three-tenths of a
mile south of the monitor’s original location (Site 10).  The new
monitoring site is similar in characteristics to the original monitoring
site.  The sites are located in the same river valley with no
obstructions between the sites and have a similar distribution of
surrounding ozone sources.  Both monitoring locations are located within
the City of Wheeling, West Virginia and the surrounding areas have
comparable population density, with no large industrial sources, and no
adjacent highways.  The current location of the Wheeling ozone monitor
is in an area which has the infrastructure and arranged access to
operate for many years.

The data from monitoring sites 7, 9, and 10 was pooled for two three-
year periods: (1) 2002, 2003, and 2004 (Sites 7 and 9) and (2) 2003,
2004 and 2005 (Sites 7, 9, 10).  In addition, the data from monitoring
sites 9 and 10 were pooled for 2004-2006.  See also, footnote 1.  The
commenter asserted that data obtained from Site 9 was a “poor site”
and that the data obtained from this site in 2004 was of low value for
purpose of the 8-hour ozone NAAQS.  EPA evaluated ozone statistics for
the Wheeling Area for 2004 (i.e. number of days with eight-hour averages
greater than 0.0084 ppm and 4th highest eight-hour average for the
year), and found them to be reasonable and consistent when compared to
ozone measurements collected in Wheeling and at other nearby monitoring
stations in the Ohio River Valley during the period examined (1998 thru
2005).

  SEQ CHAPTER \h \r 1 Based on a review of ozone air quality data from
the Wheeling Area for this period, the proximity and characteristics of
the monitoring sites, and giving consideration to WVDEP’s reasons for
relocating the ozone monitoring station during period of 2003-2005, EPA
has concluded that the integrity of ozone data submitted for this Area
was not affected by the fact that the data was collected from three
different, and relatively close together, monitoring locations.  This
data is acceptable for purposes of redesignating the Wheeling Area to
attainment of the 8-hour ozone NAAQS.

Comment:  The commenter asserts that cold and wet summers, rather than
enforceable emissions reductions are a significant cause of improvement
of air quality in Wheeling, although the commenter also asserts based on
the number of days exceeding 84 ppb in 2005 that the air quality is
actually not improving.

Response:  In accordance with Appendix I to 40 CFR Part 50, compliance
with the 8-hour ozone NAAQS is met at an ambient air monitoring site
when the 3-year average of the annual fourth-highest daily maximum
8-hour average ozone concentration is less than or equal to 0.08 ppm; it
is not based on the number of days which exceed the 8-hour ozone
standard.  Additionally, EPA uses the three-year averaging period to
minimize year to year variations in the summer (i.e., ozone season)
weather.  See Redesignation of Pittsburgh, Pennsylvania, 66 FR 53094,
53100 (October 19, 2001).  Therefore, the number of days exceeding 84
ppb are not relevant to a determination of whether an area (or portion
thereof), has attained the 8-hour ozone NAAQS.  Information relative to
long term trends of West Virginia summer temperatures and rainfall-based
data was obtained from the National Oceanic and Atmospheric
Administration’s (NOAA) National Climate Data Center (please see
attached).  Based on EPA’s review, this information shows that the
summers 2000 through 2006 experienced year to year variations in average
summer temperature and rainfall typical of the summer seasons in the
State of West Virginia.  Thus the improvement in air quality is not due
to unusually cold and wet summers.  Rather, the improvement in air
quality is due to the implementation of permanent and enforceable
measures as explained in the NPR.  The permanent and enforceable
measures listed in the Wheeling NPR include the National Low Emissions
Vehicle (NLEV), motor vehicle fleet turnover with new vehicles meeting
the Tier 2 standards, and the Clean Diesel Program.  These federal
vehicle programs along with the NOx SIP Call resulted in a 0.9 tons per
year (tpy) decrease in VOC emissions and a 69.8 tpy decrease in NOx
emissions throughout the Wheeling Area between 2002 and 2004.
Therefore, EPA believes that the improvement in 8-hour ozone air quality
is a result of identifiable, permanent and enforceable reductions in
ozone precursor emissions, not unusually cold and wet summers.

Comment:  The commenter requests air quality data for time periods
outside the time period be used for redesignation, and for areas outside
the West Virginia portion of the Wheeling Area which is the subject of
this rulemaking, and other air quality data such as data provided by the
Clean Air Status and Trends Network (CASTNET) and the National
Atmospheric Deposition Program (NADP) monitoring networks which has not
been used to support this rulemaking.  The commenter also insists that
monitoring data from a rural ozone monitoring site, a CASTNET monitor,
located in adjacent Noble County, Ohio should have been considered in
this rulemaking.

Response:  As discussed previously, the redesignation is demonstrated by
the quality assured 2002-2004 ozone monitoring data, and continued
attainment of the 8-hour ozone NAAQS is demonstrated by the quality
assured 2005 and 2006 ozone monitoring data for the Wheeling Area.
Other air quality data, from other monitoring networks or for time
periods outside the years being used to support the redesignation
request, or which are located outside the Wheeling Area (i.e Noble
County, OH CASTNET monitor), are not relevant to the redesignation
request.  Furthermore, CASTNET and NADP monitors are not operated for
purposes of the regional ozone monitoring network nor do they satisfy
the quality assurance requirements necessary to support requests for
redesignation.

Additionally, the United States Court of Appeals for the District of
Columbia Circuit  recently vacated EPA’s April 30, 2004 “Final Rule
to Implement the 8-Hour Ozone National Ambient Standard” (the Phase 1
implementation rule).  South Coast Air Quality Management District v.
EPA, 472 F.3d 882 (D.C. Cir. 2007).  EPA issued a supplemental proposed
rulemaking that set forth its views on the potential effect of the
Court’s ruling on this and other proposed redesignation actions.  72
FR 13452 (March 22, 2007).  EPA proposed to find that the Court’s
ruling does not alter any requirements relevant to the proposed
redesignations that would prevent EPA from finalizing these
redesignations, for the reasons fully explained in the supplemental
notice.  EPA provided a 15-day review and comment period on this
supplemental proposed rulemaking.  The public comment period closed on
April 6, 2007.  EPA received six comments, all supporting EPA’s
supplemental proposed rulemaking, and supporting redesignation of the
affected areas.  EPA recognizes the support provided in these comments
as well, but again, we do not believe any specific response to comments
is necessary with respect to these comments.  In addition, several of
these comments included additional rationale for proceeding with these
proposed redesignations.  EPA had not requested comment on any
additional rationale, does not believe any additional rationale is
necessary, and similarly does not believe any specific response to these
comments is necessary, and thus has not provided any.

III.  Final Action

EPA is approving the State of West Virginia’s July 24, 2006
redesignation request and maintenance plan because the requirements for
approval have been satisfied.  EPA has evaluated West Virginia’s
redesignation request, submitted on July 24, 2006, and determined that
it meets the redesignation criteria set forth in section 107(d)(3)(E) of
the CAA.  EPA believes that the redesignation request and monitoring
data demonstrate that Wheeling has attained the 8-hour ozone standard.
The final approval of this redesignation request will change the
designation of Wheeling from nonattainment to attainment for the 8-hour
ozone standard.  EPA is approving the associated maintenance plan for
Wheeling, submitted on July 24, 2006, as a revision to the West Virginia
SIP.  EPA is approving the maintenance plan for Wheeling because it
meets the requirements of section 175A.

EPA is also approving the MVEBs submitted by West Virginia in
conjunction with its redesignation request.  In this final rulemaking,
EPA is notifying the public that we have found that the MVEBs for NOx
and VOCs in the Wheeling 8-hour ozone maintenance plan are adequate and
approved for conformity purposes.  As a result of our finding, Marshall
and Ohio Counties must use the MVEBs from the submitted 8-hour ozone
maintenance plan for future conformity determinations.  The adequate and
approved MVEBs are provided in the following table:

Adequate and Approved Motor Vehicle Emissions Budgets (MVEBs) in Tons
Per Day (TPD)

Budget Year	NOx	VOC

2009	4.3	2.5

2018	1.7	1.4

Wheeling is subject to the CAA’s requirements for basic ozone
nonattainment areas until and unless it is redesignated to attainment.

IV.  Statutory and Executive Order Reviews

A.  General Requirements

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this final
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 Fed. Reg. 28355 (May 22, 2001)).  This action
approves state law as meeting Federal requirements and imposes no
additional requirements beyond those imposed by state law.
Redesignation of an area to attainment under section 107(d)(3)(e) of the
Clean Air Act does not impose any new requirements on small entities.
Redesignation is an action that affects the status of a geographical
area and does not impose any new regulatory requirements on sources.
Accordingly, the Administrator certifies that this final rule will 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 rule approves pre-existing requirements under state law and
does 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 (Public Law 104-4).  This final rule also does 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), nor will it 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), because it affects the status of a
geographical area, does not impose any new requirements on sources, or
allow the state to avoid adopting or implementing other requirements,
and does not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act.  This final rule also
is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997),
because it approves a state rule implementing a Federal standard.  In
reviewing SIP submissions, EPA’s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  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 SIP submission for failure to use VCS.  It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission; to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act.  Redesignation is an
action that affects the status of a geographical area and does not
impose any new requirements on sources.  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.  As required by section 3 of
Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this
final rule, EPA has taken the necessary steps to eliminate drafting
errors and ambiguity, minimize potential litigation, and provide a clear
legal standard for affected conduct.  EPA has complied with Executive
Order 12630 (53 FR 8859, March 15, 1988) by examining the takings
implications of the rule in accordance with the “Attorney General’s
Supplemental Guidelines for the Evaluation of Risk and Avoidance of
Unanticipated Takings” issued under the executive order.

B.  Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States.  EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.  This rule is not a
“major rule” as defined by 5 U.S.C. 804(2).

C.  Petitions for Judicial Review

Under section 307(b)(1) of the Clean Air Act, petitions for judicial
review of this action must be filed in the United States Court of
Appeals for the appropriate circuit by [insert date 60 days from date of
publication of this document in the Federal Register].  Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action.

This action, to approve the redesignation request, maintenance plan and
adequacy determination for MVEBs for Wheeling, may not be challenged
later in proceedings to enforce its requirements.  (See section
307(b)(2)).

List of Subjects

40 CFR Part 52

Environmental protection, Air pollution control, Intergovernmental
relations, Ozone, Nitrogen Dioxides, Reporting and recordkeeping
requirements, Volatile organic compounds.

40 CFR Part 81

Environmental protection, Air pollution control, National parks,
Wilderness areas

						                          /s/

___________				                        ___________________________

Dated: 	 May 8, 2007				   	William T. Wisniewski, Acting

							Regional Administrator,

							Region III.

40 CFR parts 52 and 81 are amended as follows:

PART 52 - [AMENDED]

1.  The authority citation for part 52 continues to read as follows:

               Authority:  42 U.S.C. 7401 et seq.

Subpart XX– West Virginia

2. In § 52.2520, the table in paragraph (e) is amended by adding an
entry for the 8-Hour Ozone Maintenance Plan, Wheeling, WV-OH Area at the
end of the table to read as follows:

§ 52.2520  		Identification of plan.

*		*		*		*		*

(e)***

Name of non-regulatory SIP revision	Applicable geographic area	State
submittal date	EPA approval date	Additional

explanation

*                    *                      *                   *
           *                 *                    *

8-Hour Ozone Maintenance Plan for the Wheeling, WV-OH Area	Marshall and
Ohio County 	07/24/06	[Insert Federal Register publication date] [Insert
page number where the document begins]

PART 81 - [AMENDED]

	3.  The authority citation for Part 81 continues to read as follows:

		Authority:  42 U.S.C. 7401 et seq.

	4.  In § 81.349 the table entitled "West Virginia - Ozone (8-Hour
Standard)" is amended by revising the entry for the Wheeling, WV-OH Area
to read as follows

§ 81.349              West Virginia

*          *          *          *          *

		West Virginia - Ozone (8-Hour Standard)

Designated Area	Designationa	Category/Classification

	Date1	Type	Date1	Type

*          *          *         *         *          *          *

Wheeling, WV-OH Area

Marshall County	[Insert date of publication]	Attainment

Ohio County	[Insert date of publication]	Attainment

*          *          *         *         *          *         *

aIncludes Indian country located in each county or area except otherwise
noted.

1 This date is June 15, 2004, unless otherwise noted.

*          *          *         *         *

 The fourth highest 8-hour ozone monitoring values at the Ohio County,
West Virginia monitor for 2006 were 0.085 ppm, 0.083 ppm, 0.079 ppm, and
0.079 ppm.  Thus the design value at the Area monitor for monitoring
years 2004-2006 are still showing attainment of the 8-hour NAAQS with a
value of 0.077 ppm at the Wheeling monitor.

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