[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Notices]
[Page 68152]
[FR Doc No: 2012-27751]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

Preparations for the 24th Session of the UN Sub-committee of
Experts on the Globally Harmonized System of Classification and
Labelling of Chemicals (GHS) and Stakeholder Meeting

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice of Public Meeting.

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

SUMMARY: OSHA invites interested parties to participate in an open,
informal public meeting to discuss proposals in preparation for the
24th session of the United Nations Sub-committee of Experts on the
Globally Harmonized System of Classification and Labelling of Chemicals
(UNSCEGHS). The UNSCEGHS meeting will be held December 12-14, 2012, in
Geneva, Switzerland. OSHA, along with the U.S. Interagency GHS
Coordinating Group, plans to consider the comments and information
gathered at this public meeting when developing the U.S. Government
positions for the UNSCEGHS meeting.

DATES: The date for the public meeting is as follows: November 28,
2012, beginning at 2 p.m., in Washington, DC.

ADDRESSES: The location for the public meeting is as follows: The U.S.
Department of Labor, Francis Perkins Building, 200 Constitution Avenue
NW., Washington, DC 20210, Room C5320, and Conference Room 6.
    Conference Call Information: Conference call-in capability will be
provided for this meeting. To participate by telephone, dial 1-800-369-
1938, and enter participant passcode 12725. During the call, please
press *6 to mute/unmute your individual lines.

FOR FURTHER INFORMATION CONTACT: Maureen Ruskin, Director, Office of
Chemical Hazards-Metals, OSHA Directorate of Standards and Guidance,
Room N-3718, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington DC 20210; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    Copies of this Federal Register notice can be obtained as follows:
Electronic copies are available at http://www.regulations.gov. This
Federal Register notice, as well as other relevant information, is
available also on the OSHA Web page at http://www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. Meeting

    OSHA is hosting an open informal public meeting of the U.S.
Interagency GHS Coordinating Group to provide interested groups and
individuals with an update on GHS-related issues and an opportunity to
express their views orally and in writing for consideration in
developing U.S. Government positions for the upcoming UNSCEGHS meeting.
The public is invited to attend without prior notification.
    The Meeting Agenda, in general, is as follows:
     Discussion of working papers for the 24th Session of the
UNSCEGHS
     Update on UNSCEGHS correspondence group activity
     Discussion of the program of work for the 2013-2014
biennium

II. Background

    The GHS was formally adopted by the United Nations Committee of
Experts on the Transport of Dangerous Goods and on the Globally
Harmonized System of Classification and Labelling of Chemicals in
December 2002. The GHS is a single, harmonized system for
classification of chemicals according to their health, physical, and
environmental effects. It also provides harmonized communication
elements, including labels and safety data sheets. The GHS is
considered to be a living document and is regularly revised and updated
as necessary to reflect new technology and scientific developments or
to provide additional explanatory text. OSHA incorporated the GHS 3rd
revision into its Hazard Communication Standard on March 26th of this
year, 77 FR 17574, and intends to update the standard from time to time
through rulemaking in order to remain consistent with any revisions to
the GHS as appropriate under the OSH Act.
    The UNSCEGHS is responsible for maintaining and updating the GHS.
The U.S. has been an active member of the UNSCEGHS for many years, and
OSHA currently serves as the head of the U.S. delegation for this Sub-
committee.
    In preparation for the bi-annual meetings of the UNSCEGHS, the U.S.
Interagency GHS Coordinating Group meets to discuss issues related to
the GHS and to develop a coordinated U.S. position on issues and
proposals regarding the GHS. The U.S. Interagency Coordinating Group
consists of U.S. agencies that regulate in the area of chemical hazard
communication and includes the Department of Transportation (DOT), the
Environmental Protection Agency (EPA), the Consumer Product Safety
Commission (CPSC), and OSHA.
    Information on the work of the UNSCEGHS, including meeting agendas,
reports, and documents from previous sessions, can be found on the
United Nations Economic Commission for Europe (UNECE) Transport
Division Web site located at the following web address: http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html. The UNSCEGHS
bases its decisions on Working Papers. The Working Papers for the 24th
session of the UNSCEGHS are located at http://www.unece.org/trans/main/dgdb/dgsubc4/c42012.html.
    Informal Papers submitted to the UNSCEGHS provide information for
the subcommittee and are used either as a mechanism to provide
information to the subcommittee or as the basis for future Working
Papers. Informal Papers for the 24th session of the UNSCEGHS are
located at: http://www.unece.org/trans/main/dgdb/dgsubc4/c4inf24.html.

Authority and Signature

    This document was prepared under the direction of David Michaels,
Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and
Health, U.S. Department of Labor, pursuant to sections 4, 6, and 8 of
the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655,
657), and Secretary's Order 1-2012 (77 FR 3912), (Jan. 25, 2012).

    Signed at Washington, DC, on November 9, 2012.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2012-27751 Filed 11-14-12; 8:45 am]
BILLING CODE 4510-26-P


generation. The numbers of implantation sites and viable litters were
similar in the treated and control

groups in both generations.  No treatment-related gross or microscopic
lesions were observed in reproductive organs.

The lowest-observed-adverse-effect level (LOAEL) for reproductive
toxicity of AE

C638206 in rats was not determined; therefore the
no-observed-adverse-effect level

(NOAEL) is >2000 ppm (>179.9 mg/kg bw/day in males and >193.3 mg/kg
bw/day in

females).

No treatment-related effects were observed on the behavior or other
clinical signs of offspring of either generation.  No treatment-related
effects were observed on litter size, sex ratio, or any survival index
(postimplantation survival, live birth, viability, and lactation
indices) in F1 or F2 offspring.  The day of attainment of sexual
maturation and the body weight at attainment were not affected by
treatment with the test material in male or female F1 offspring.  Body
weight was significantly reduced by 7-13% in high-dose group F1 and F2
male and female pups 14, 21, and 28 days old.  Weight gain over the
28-day postnatal period was significantly decreased by 8-9% in high-dose
F1 male and female pups and by 11-14% in high-dose F2 male and female
pups compared with that of controls due primarily to decreases in weight
gain occurring after

postnatal day 7.  Statistically significant changes in organ weights in
F1 and F2 weanlings

(absolute and/or relative spleen, thymus and/or brain) were not
accompanied by gross lesions in these organs and microscopic
examinations were not conducted.

The lowest-observed-adverse-effect level (LOAEL) for offspring toxicity
of AE C638206 in rats is 2000 ppm (144.6-179.9 mg/kg by/day in males and
159.7-193.3 mg/kg bw/day in females) based on decreases in body weight
and weight gain F1 and F2 male and female pups.  The
no-observed-adverse-effect level (NOAEL) is 500 ppm (36.4–43.7 mg/kg
bw/day for males and 41.0-46.9 mg/kg bw/day in females).

Kidney toxicity was observed in the parental animals at the high-dose
level; therefore, the

animals in this study were adequately dosed to assess both reproductive
and offspring toxicity.

This study is Acceptable/Guideline and it satisfies the guideline
requirement for a two-

generation reproductive study (OPPTS 870.3800); OECD 416 in rats.

A.3.4	Chronic Toxicity

	870.4100a (870.4300) Chronic Toxicity – Rat

A combined chronic toxicity/carcinogenicity study in rats is included in
section A.3.5 below.

	870.4100b Chronic Toxicity – Dog

In a chronic toxicity study (MRID 46474128) AE C638206 (95.9%, Lot No.
OP2050046) was administered to 5 beagle dogs/sex/dose by oral gavage at
concentrations of 0, 70, 300 and 1000 mg/kg/day for 52 weeks.

There were no significant compound-related effects based on mortality,
clinical signs, food consumption, opthalmoscopic examinations,
urinalysis, hematology, clinical chemistry, organ weight, gross
pathology or histopathology.  Body weight gain was inhibited in males
treated with 1000 mg fluopicolide/kg/day.  Although increased
cholesterol concentrations at the end of the study were statistically
significant and slightly above the historical range in females treated
with 1000 mg/kg/day, there were no correlative changes indicating an
exposure-related effect on lipid metabolism in these animals.  One
female in the 300 mg/kg/day dosage group died during the study, however,
the death was not conclusively associated with exposure to fluopicolide.

The LOAEL for AE C638206 in male dogs was 1000 mg/kg/day based on
decreased body weight gain.  The NOAELs were 300 and 1000 mg/kg/day for
males and females, respectively.

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

A.3.5	Carcinogenicity

	870.4200a Carcinogenicity Study – rat

In a combined chronic toxicity/carcinogenicity study (MRID 46474139), AE
C638206 (Fluopicolide, 95.9%, a.i.; Batch No. OP2050046) was
administered to 60 Crl:CD (SD) IGS BR rats/sex/dose in the diet at
concentrations of 0 (controls), 50, 200, 750 or 2500 ppm (equivalent to
0, 2.1, 8.4, 31.5 or 109.4 mg/kg bw/day in males and 0, 2.8, 10.8, 41.0
or 142.2 mg/kg bw/day in females) for up to 104 weeks.  An additional 20
animals/sex/dose were administered the same concentration and sacrificed
after 52 weeks of treatment for a interim sacrifice.  A third set of 10
animals/sex/dose were fed the treated diet at the same concentrations
for 52 weeks followed by 13 weeks of being fed basal diet prior to
sacrifice in a recovery study.  A report, MRID 46474138, which consisted
of a summary of the study profile was provided as an additional source
of information.

Statistical analysis showed no increased incidence of mortality in any
of the treated groups compared to controls.  The only clinical signs
observed were in the females rats and consisted of yellow perigenital
staining, brown staining of the pinna and brown staining of the dorsum.
Statistical significance was not evaluated for these clinical signs.
Yellow perigenital staining and the brown staining of the pinna was
observed primarily in the 2500 ppm females in the main study with these
signs beginning around week 13 and increasing to weeks 47-53 when they
were observed in 21-31% of the females at 2500 ppm.  Both effects then
started to diminish and were

seen in few animals (<5%) by the end of the second year.  Similar
results were observed in the 52 week study.  Brown staining of the
dorsum was observed but was not seen in a concentration-related
increase, affecting controls as well as treated females.  These clinical
signs appear to be of low toxicological significance due to a lack of
corresponding urinalysis, clinical chemistry or histopathology effects
identified, and they were transient with most effects minimizing after
the first year.  While palpable masses were observed and monitored,
there was not a treatment-related increase in the incidence of these
masses.

There was no statistically significant difference in body weight in any
of the treated groups.  A statistically significant (p< 0.05 or p<0.01)
decrease in mean body weight gain was observed in weeks 0-1 in both
studies at the highest dose in males (33%) and females (28%), compared
to controls.  In the main study, a statistically significant (p<0.01)
decrease was also seen in the females at 200 (20%) and 750(32%) ppm
groups.  The only significant decrease in body weight gain in weeks 1-2
of the main study was in males at 2500 ppm and females at 50 and 2500
ppm, and these gains were decreased 11% in the males and 15 and 42% in
the females, respectively, compared to controls.  After this time, body
weight and body weight gain remained lower than controls (n.s.) with the
overall body weight gain of the 2500 ppm group being 11% and 17% less
than controls in the males and females, respectively.  In the animals
dosed for 52 weeks, the similar effect of decreased body weight gain in
the highest dosed males and females was

observed with statistical significance in the first 2 weeks.  Both male
and female rats had

comparable body weight gain by the end of the recovery period.  A
corresponding decrease in

food consumption and food efficiency was observed in the highest dosed
group of males and females during the first two weeks of treatment;
however, statistical analysis was not included in the report.

Statistical differences in hematology and clinical chemistry were not
toxicologically significant.  Those observed were minor, sporadic and
did not have a clear treatment-related association.

Statistically significant increases (p<0.01 or 0.05) in relative (to
body weight) and absolute kidney (122- 137%), thyroid (154-163%) and
liver (122-134%) weights were observed in the males at 2500 ppm in the
main study.  These same increases were observed in the males at 2500 ppm
in the 52 week study, except for absolute kidney weight.  Females at
2500 ppm in the 52 week study had statistically significant increases in
relative, but not absolute, liver and kidney weights; this was
associated with a significant decrease in terminal body weight.

Males had a statistically significant increase in the incidence of and
severity of non-neoplastic microscopic lesions in the thyroid, kidney
and liver in the main study.  A corresponding increase (p< 0.05) in the
incidence of enlarged kidneys and thyroids were present in the males at
2500 ppm compared to controls on gross observation.  On
histopathological examination, an increased incidence of thyroid cystic
follicular hyperplasia was present in the males and observed in 0/60,
1/37, 0/37, 4/35 and 7/60 (p < 0.05) in the controls, 50, 200, 750 or
2500 ppm males.  Lesions in the kidney were those associated with the
alpha -2u-globulin accumulation normally present in male aged rats and
are not considered adverse or applicable to human risk assessment.  The
liver effect, centrilobular hepatocyte hypertrophy, observed both at 52
and 104 weeks was considered to be an adaptive change due to treatment.
During the recovery period, all lesions present were reversed except for
a slight increase in the severity of the renal cortical tubular
basophilia in the males.  Females had no statistically significant
differences in lesions in any of the dose groups in either the toxicity
or the main study.

The lowest-observed-adverse effect level (LOAEL) for AE C638206 in rats
is 2500 ppm (109.4 and 142.2 mg/kg/day for males and females,
respectively) based on decreases in body weight gain (M and F) and an
increase in thyroid organ weight with corresponding increases in the
incidence of thyroid lesions (M only).  The no-observed-adverse effect
level (NOAEL) for AE C638206 is 750 ppm (31.5 and 41.0 in males and
females, respectively).

At the doses tested, there was not a treatment related increase in tumor
incidence of any type in animals dosed with up to 2500 ppm AE C638206
for up to 104 weeks.  Dosing was considered adequate based on the
decreased body weight gain in the male and female rats at 2500 ppm, and
the non-neoplastic lesions observed at 2500 ppm in males.  While effects
were minimal in the female, a reproductive study, MRID 46474124 (main
study) and 46474125 (supplemental study histopathological evaluation of
liver and kidneys) indicated kidney toxicity (microscopic

lesions) in male and female rats in both parental generations and
decreased body weight

gain in the F0 females treated with AC638206 for 16 weeks at 2000 ppm
indicating adequate dosing in this study at 2500 ppm.

This chronic/carcinogenicity study in the rat is Acceptable/Guideline
and satisfies the guideline requirement for a chronic/carcinogenicity
study [(OPPTS 870.4300); OECD 453] in rats.

	870.4200b Carcinogenicity (feeding) – Mouse

In a carcinogenicity study (MRID 46474130) AE C638206 (Fluopicolide)
(95.9% a.i., batch #OP2050046) was administered to 50 C57BL/6
mice/sex/dose in the diet at dietary levels of 0, 50, 400, or 3200 ppm
(equivalent to 0, 7.9, 64.5, 551.0 mg/kg bw/day for males, and 0, 11.5,
91.9, and 772.3 mg/kg bw/day for females) for 18 months.  Satellite
groups of 10 C57BL/6 mice/sex/dose were similarly treated for 12 months.
 Historical control incidences of hepatocellular lesions were provided
(MRID 46474135).

2/10 for each lesion).

The LOAEL for AE C638206 in mice is 3200 ppm for both sexes (551.0
mg/kg/day for males, 772.3 mg/kg/day for females), based on severely
decreased body weights and body weight gains and liver lesions in both
sexes.  The NOAEL is 400 ppm in both sexes (64.5 mg/kg/day for males,
91.9 mg/kg/day for females).

At the doses tested, there was a treatment related increase in the
incidence of hepatocellular adenoma when compared to controls.  The 3200
ppm animals had statistically significant increases in hepatocellular
adenoma in both sexes after 78 weeks, and a small increase after 52
weeks.  The adenoma incidence after 78 weeks at 0, 50, 400 and 3200 ppm
was 5/50, 0/50, 5/50, and 11/50, respectively, for males, and 1/50,
2/50, 0/50, and 16/50, respectively, for females.  After 52 weeks,
hepatocellular adenoma was found in 3/10 high-dose females but no males.
   The adenomas were correlated with an increased incidence of liver
masses and nodules at necropsy.  Dosing was considered adequate based on
decreased body weight gains, decreased food efficiency, and liver
lesions seen in both sexes at the high dose.

This carcinogenicity study is Acceptable/Guideline and satisfies
guideline requirements for a carcinogenicity study [OPPTS 870.4200b;
OECD 451] in mice.

A.3.6	Mutagenicity

	Gene Mutation

Guideline 84-2, Reverse gene mutation

MRID 46474146

Unacceptable/guideline

	dose range:  1.6 to 5000 µg/plate

No increases in revertant colonies were found in either test series at
concentrations up to the limit dose, 5000 µg/plate. Therefore,
AEC638206 00 IC99 0005 is considered nonmutagenic in the conventional
battery of bacterial strains.

This study was considered unacceptable/guideline because purity
information for the test material was not provided.

Guideline 84-2, Reverse gene mutation

MRID 46474202

acceptable/guideline

	dose range:  1.6 to 5000 µg/plate

No increases in revertant colonies were found in either test series at
concentrations up to the limit dose, 5000 µg/plate. Therefore,
AEC638206 00 IC99 0001 is considered nonmutagenic in the conventional
battery of bacterial strains.

Guideline 84-2, Reverse gene mutation

MRID 46474148

acceptable/guideline

	dose range:  1.6 to 5000 µg/plate

No increases in revertant colonies were found in either test series at
concentrations up to the limit dose, 5000 µg/plate. Therefore,
AEC638206 00 IB99 0002 is considered nonmutagenic in the conventional
battery of bacterial strains.

Guideline 84-2, Reverse gene mutation

MRID 46474144

acceptable/guideline

	dose range:  1.6 to 5000 µg/plate

No increases in revertant colonies were found in either test series at
concentrations up to the limit dose, 5000 µg/plate. Therefore,
AEC638206 Technical is considered nonmutagenic in the conventional
battery of bacterial strains.

Guideline 84-2, Reverse gene mutation

MRID 46474142

acceptable/guideline

	dose range:  5 to 5000 µg/plate

AE C638206 (fluopicolide) is considered mutagenic at precipitating
concentrations in the conventional battery of bacterial strains.

	Cytogenetics

Guideline 84-2, in vitro mammalian cells in culture/gene mutation assay
in Chinese hamster lung cells

MRID 46474204

Acceptable/guideline

	1.2 to 3820 µg/mL,  0.4 to 120 µg/mL and 0.313 to 60 µg/mL with and
without activation

No concentration in any of the three experiments was a biologically
relevant, reproducible increase in mutant colonies found at
concentrations up to the highest subcytotoxic levels.  Both positive
controls showed marked increases.

Guideline 84-2, in vivo mammalian chromosome
aber慲楴湯൳前䑉㐠㐶㐷〲സ捁散瑰扡敬术極敤楬敮܍⸱
㔲琠㈶‵枵洯⁌楷桴畯⁴捡楴慶楴湯愠摮㐠㠮‸潴㘠
㔲딠⽧䱭眠瑩捡楴慶楴湯

In the presence of  ≥50% reduction in the MI, no statistically
significant increases in the structural or numerical (polyploidy)
aberrant metaphases were found at any test concentration in either
trial, compared to marked (p≤0.001) increases in both positive
controls.

Guideline 84-2, in vitro mammalian chromosome aberrations

MRID 46474206

Acceptable/guideline

	3.2 to 100 µg/mL with and without activation; 0.1 to 6.3 µg/mL
without activation

This batch mixture of AE C638206 is considered a clastogen in the in
vitro Chinese hamster lung (V79) cell system in the absence of S9
activation.

Guideline 84-2, in vivo mammalian cytogenetics

MRID 46474214

Acceptable/guideline

	IP injection of 150, 300 or 600 mg/kg/day

No dose up to the HDT was a significantly increased number of mPCEs
recorded, in the presence of a statistically increased ratio of PCEs to
NCEs (evidence of interference with erythropoiesis), either when
compared to vehicle controls, or to the laboratory’s 8-year historical
control data base. The positive control registered a marked increase in
mPCEs, in the absence of any alteration of erythropoietic effects.

Guideline 84-2, in vivo mammalian cytogenetics

MRID 46474210

Acceptable/guideline

	Two oral doses of 200, 600, or 2000 mg/kg/day, 24 hours apart

No adverse clinical signs were observed during the main study. The ratio
of polychromatic to normochromatic erythrocytes was unaffected by
treatment. Additionally, at no dose level up to the limit dose, (2000
mg/kg/day), were increased numbers of mPCEs induced by the test article,
compared with the marked increases observed in CPA-treated cells.

	Other Genotoxicity

Guideline (no # given),  Unscheduled DNA synthesis in hepatocytes

MRID 46474216

acceptable/guideline	600 or 2000 mg/kg

There was no evidence (or a dose-related positive response) that
unscheduled DNA synthesis, as determined by radioactive tracer
procedures (nuclear silver grain counts) was induced at either timed
sacrifice in rats exposed to the test material up to the limit dose
(2000 mg/kg).

A.3.7	Neurotoxicity

	870.6100 Delayed Neurotoxicity Study – Hen

Not required for this chemical.

	870.6200 Acute Neurotoxicity Screening Battery

In an acute neurotoxicity study (MRID 46474218; summarized in MRID
46474217), groups of fasted, 6- to 7-week old CD rats (10/sex) were
given a single oral dose of AE C638206 (95.9% a.i., batch/lot
#OP2050046) in 1% methylcellulose at doses of 0, 10, 100, or 2000 mg/kg
bw and observed for 15 days.  Doses were based on a range-finding study
in which single doses of 50 mg/kg induced behavioral changes (MRID
46474219).  Neurobehavioral assessment (functional observational battery
[FOB] and motor activity testing) was performed in 10 animals/sex/group
pretreatment, on Day 1 (at six hours post-dosing, the time of peak
effect), and on Days 8 and 15.  Cholinesterase activity was not
determined.  At study termination, 5 animals/sex/group were euthanized
and perfused in situ for neuropathological examination.  Of the perfused
animals, the control and high-dose groups were subjected to
histopathological evaluation of brain and peripheral nervous system
tissues.

There was no effect of treatment on body weight, body weight gain, food
consumption, food efficiency, brain weight, brain measurements (cerebral
hemispheres), or incidence of gross or microscopic lesions.  Lower body
temperature in the high-dose males and females at the time of peak
effect (6 hours post-dosing) on the day of treatment (Day 1) was the
only treatment-related observation during the FOB.  This sign was not
observed on Days 8 or 15.  A statistically significant decrease in
forelimb grip strength in females in the 2000 mg/kg group on Day 8,
reduced motor activity of males in the 2000 mg/kg treatment group on Day
1, and increased motor activity in females in the 2000 mg/kg group on
Day 15 were considered incidental to treatment as these effects were not
clearly dose-related and were not observed in the other sex.

The LOAEL for AE C638206 in male and female rats was 2000 mg/kg, based
on the transient effect of lower body temperature.  The NOAEL for male
and female rats was 100 mg/kg.

This neurotoxicity study is classified as Acceptable/Guideline, and
satisfies the guideline

requirement for an acute neurotoxicity study in rats (870.6200; OECD
424) provided positive

control neuropathology data are submitted by the conducting laboratory.

	870.6200 Subchronic Neurotoxicity Screening Battery

In a subchronic neurotoxicity study (MRID 46474221), Technical Grade AE
C638206 (97.8% a.i., Batch # OP2050046) was administered to 10 CD
rats/sex at dietary concentrations of 0, 200, 1400, or 10,000 ppm for 13
weeks.  Time-weighted average doses were 0, 15.0, 106.6, or 780.6
mg/kg/day, respectively, for males and 0, 18.0, 125.2, or 865.8
mg/kg/day, respectively, for females.  Neurobehavioral assessment
(functional observational battery [FOB] and motor activity testing) was
performed on all animals pre-test and at weeks 4, 8, and 13.  At study
termination, 6 animals/sex/group were euthanized and perfused in situ
for neuropathological examination.  Of the perfused animals, control and
high-dose rats were subjected to histopathological evaluation of brain
and peripheral nervous system tissues.  Positive control data for FOB
and motor activity testing were submitted in MRID 46474222 and were
summarized in MRID 46474220.

All animals survived to scheduled sacrifice.  No treatment-related
clinical signs of toxicity or gross lesions were observed in any group.
FOB findings and motor activity were similar between the treated and
control groups.

Mean body weight of the low-dose males and females was similar to the
controls throughout the study.  Mid- and high-dose males and females had
slightly lower body weight than that of the control group beginning at
week 1 but these data were not analyzed statistically.  Overall body
weight gain by the high-dose males and females and mid-dose females was
81%, 72%, and 87% (p  0.05 or 0.01), respectively, of the respective
control levels.  The most pronounced effect on body weight gain in the
high-dose groups was during weeks 0-1 when males and females gained 56%
and 63%, respectively, of the control level.  Weight gain by the
mid-dose groups appeared to be consistently less than that of controls
at each weekly interval.  Food consumption by the high-dose males and
females was slightly less than that of the controls for most weekly
intervals of the study.  Excessive food scatter was observed by the mid-
and high-dose males and by all treated female groups.  Overall food
conversion efficiency by the high-dose males and females and mid-dose
females was 87%, 79%, and 89%, respectively, of the respective control
levels.  The most pronounced effect on food efficiency in the high dose
groups was during week 1 when males and females were 62% and 69%,
respectively, of the control level.

Treatment-related lesions observed in the liver (hypertrophy) of males
and females and the male kidney (hyaline droplets) were not considered
adverse or relevant to humans.

Therefore, the systemic and neurotoxicity LOAEL for AE C638206 in male
and female rats is 10,000 and 1400 ppm, respectively (780.6 and 125.2
mg/kg/day for males and females, respectively) based on decreased body
weight gain, food consumption, and food efficiency.  The NOAEL for males
and females was 1400 and 200 ppm, respectively (106.6 and 18.0 mg/kg/day
for males and females, respectively).

The study is classified as Acceptable/Guideline and does satisfy the
guideline requirement for a subchronic neurotoxicity study in rats
(870.6200b) provided positive control neuropathology data are submitted
by the conducting laboratory.

	870.6300 Developmental Neurotoxicity Study

Not required for this chemical.

A.3.8	Metabolism

	870.7485	Metabolism - Rat

Five studies (MRIDs 46474226, 46474239, 46474241, 46474242, and
46474244) were conducted to examine the metabolism and disposition of AE
C638206 (fluopicolide) in male and female Sprague-Dawley CD rats
following single doses of [14C-2,6-pyridyl]-AE C638206 at 10 mg/kg bw or
[14C-2,6-pyridyl]-AE C538206 and [14C-U-phenyl]-AE C638206 at 10 and 100
mg/kg bw.  Rats were subjected to the dosing regimens above using
[14C-2,6-pyridyl]-AE C538206 (lot nos. 903AE-3 and GAR 2034-/4; >99% and
97% radiochemical purity) or [14C-U-phenyl]-AE C538206 (lot no. CFQ
12747; 99.1% radiochemical purity) and nonlabeled test article (batch
no. R001737, 99.3% chemical purity).  Excretion, tissue distribution,
pharmacokinetics (blood/plasma), and metabolite profiles were
determined.  In MRID 46474242, metabolite profiles were assessed in
urine and fecal extracts of male and female rats given a single oral 10
mg/kg bw dose of [14C-2,6-pyridyl]-AE C638206 and sacrificed at 48 hours
post-dosing.

There were no biologically significant treatment-related effects noted
during the course of the study.  Overall recovery of administered
radioactivity was an acceptable 93.9-103.6%.  The data supported the
contention that AE C538206 is readily absorbed and rapidly excreted
within 72 hours following a single oral dose of 10 mg/kg.  Fecal
elimination accounted for 68.8-72.4% of the administered radioactivity
whereas urinary excretion accounted for only 18.8-21.4% of the
administered radioactivity.  In the bile excretion study (MRID
46474244), 51.7% of the administered radioactive dose in both sexes was
excreted by the cannulated bile duct indicating a significant portion of
the radioactivity recovered in feces is derived from hepatic metabolism
of AE C638206.  Time-course blood/plasma and tissue studies revealed
rapid absorption and distribution of administered radioactivity to all
organs and tissues followed by moderately rapid excretion with reduction
to background levels in most tissues and organs within 72 hours.  Tissue
concentrations peaked at 6-7 hours post-dosing and about 96% of the peak
tissue concentrations were dissipated between 6-7 hours and 168 hours
post-dose.  Absorption and excretory patterns did not exhibit
gender-related variability, but blood/plasma kinetic studies (MRID
46474226) suggest near-saturation of absorption at the high dose (100
mg/kg bw).  Based upon tissue burden data, neither AE C638206 nor its
metabolites appear to undergo any significant tissue sequestration.
With the exception of transiently higher levels in the liver, kidneys,
and intestines during the elimination phase, radioactivity
concentrations in any given tissue consistently represented considerably
less than 1% of the administered dose within 24 hours of administration
of AE C638206.

Both urinary and fecal metabolites were quantified by HPLC and most were
identified using HPLC or HPLC/MS in conjunction with known standards.
The major metabolites identified appeared to be oxidative N-dealkylation
cleavage products.  Extraction efficiency appeared to be excellent and
most components in both of the matrices examined (urine and feces) were
adequately quantified and characterized.  The available data, based upon
studies using [14C-2,6-pyridyl]-AE C638206, affirmed the metabolism
pathway (Appendix, Figure 1) proposed by the investigators.

These metabolism studies (MRID 46474226, 46474239, 46474241, 46474242,
and 46474244) are, collectively, Acceptable/Guideline and satisfy the
requirements for a Metabolism and Pharmacokinetics Study
[OPPTS 870.7485 (§85-1)].  The studies were properly designed,
conducted and reported.

	870.7485	Metabolism - Rat

In a non-guideline metabolite identification study (MRID 46708632), five
pooled urine samples from rats given a single oral dose (amount not
provided) of [Pyridyl-2,6-14C]AE C638206 (Batch/Lot # and radiochemical
purity not provided) were analyzed by LC/MS(MS).  Urine was pooled from
male rats at 0-6, 6-24, and 24-48 h after administration of the
radiolabeled test substance, while urine from females was pooled at 0-6
and 24-48 h post-administration.  Structure proposals of identified
metabolites and corresponding fragmentation schemes and spectra were
generated.

Thirty-six metabolite structures (or sets of alternative structures)
were proposed for all relevant signals of the five urine samples.  Six
metabolites identified in a previously performed rat metabolism study
and two metabolites identified in non-animal metabolism studies were
confirmed.  Most of the metabolites observed were derivatives of AE
C638206 fitting well with the prior known metabolites, implying cysteine
or N-acetyl-cysteine introduction on the phenyl ring from gluthione
conjugation, hydroxylation, or other conjugations.  For some compounds
containing no chlorine, polar biomolecules or bioconjugates with no
relationship to the parent instead of the proposed metabolites can not
be excluded.

This metabolite identification study in the rat is classified
acceptable/non-guideline.

	870.7485	Metabolism - Rat

In a metabolism study (MRID 46708636) [Pyridyl-2,6-14C]-AE C657188
(Batch # DCR25/1; radiochemical purity 99.0%) suspended in aqueous 0.75%
methyl cellulose was administered by oral gavage to four Sprague Dawley
(SD) rats/sex at a dose level of 10 mg/kg.  The recovery of
radioactivity over five days was determined, and the concentrations of
radioactivity in tissues and excreta were determined.  Metabolites were
identified and quantified in the urine and feces.  AE C657188
[3-chloro-5-(trifluoromethyl)pyridine-2-carboxylic acid] is a
significant plant metabolite of fluopicolide (AE C638206); therefore,
the present study was performed to assess the absorption, distribution,
metabolism, and excretion of this compound.

Total radioactivity recovered was 93-94% of the administered dose, with
no sex differences observed.  The majority of the radioactivity was
recovered in the urine, while feces was a lesser route of elimination.
The minimum levels of absorption were estimated from the total recovery
of radioactivity in urine, cage washes, and tissues.  From these, it was
estimated that at least 87% of the administered dose was absorbed,
indicating high oral bioavailability.  Very little radioactivity
remained in the tissues 120 h post-dosing.  Low levels of radioactivity
were only detected in the residual carcass and the skin and fur.  These
data did not suggest bioaccumulation; however, tissue concentrations
were assayed at only one time point.

The test compound was not appreciably metabolized.  HPLC analyses of
urine and fecal extract samples resolved up to nine peaks in the urine
and three peaks in the feces; however, only one major peak was detected
in both urine and feces.  The retention time of this peak corresponded
to that of unmetabolized parent.  This was confirmed by
co-chromatography and MS/MS of the urine and fecal extracts spiked with
[14C]-AE C657188.  Parent accounted for a total of 79-86% of the
administered dose.  All other peaks were <1.4% of the administered dose,
and were not identified.

This metabolism study in the rat is classified acceptable/guideline and
satisfies the guideline requirement for a Tier 1 metabolism study [OPPTS
870.7485, OECD 417] in rats.

	870.7485    Metabolism – Rat

AE C653711 (2,6-dichlorobenzamide) is a soil metabolite of fluopicolide
(AE C638206) that is taken up into crops to form crop residues;
therefore, the present study was performed to assess the absorption,
distribution, metabolism, and excretion of this compound.  In a series
of metabolism studies (MRIDs 46708633, 46708634, and 46708635)
[Phenyl-U-14C]-AE C653711 (Batch # SEL/1059; radiochemical purity >98%)
suspended in aqueous 0.75% methyl cellulose was administered by oral
gavage to three groups of Sprague Dawley rats/sex.  Two groups of four
rats/sex were given a single dose of [14C]-AE C653711 at dose levels of
10 or 150 mg/kg.  A third group of five rats/sex was given 14 daily
doses of [14C]-AE C653711 at a dose level of 10 mg/kg.  The recovery of
radioactivity over six days (seven days for the single high dose group)
was determined, and the concentrations of radioactivity in tissues and
excreta were determined.  Metabolites were identified and quantified in
the urine and feces.

Total recovery ranged from 92.2-98.6% of the administered doses, with no
differences observed between sexes, dose levels, or single or multiple
doses.  The majority of the radioactivity was recovered in the urine.
Absorption and excretion of the test compound was relatively rapid.  The
minimum levels of absorption were estimated from the total recovery of
radioactivity in urine, cage washes, and tissues to be at least
77.7-85.9% of the administered dose, indicating high oral
bioavailability.  Excretion of radioactivity in the urine and feces was
mostly complete by 48 (single low dose study) to 72 (single high dose
and repeat low dose studies) h post-dosing.  The tissues (including the
residual carcass) accounted for <2.2% of the administered dose 144 or
168 h post-dosing.  In general, the highest concentrations of
radioactivity were detected in the kidneys, liver, Harderian gland, skin
(and fur), and adrenals.

The test compound was extensively metabolized to at least 18 compounds.
The majority of radioactivity in urine and fecal extract samples was
present as parent and a mercapturic acid conjugate of
hydroxyl-chlorobenzamide.  Metabolic profiles were qualitatively similar
across dose levels, multiple doses had no appreciable effect on
metabolism, and generally, no differences were noted between sexes.  In
excreta, parent and identified compounds accounted for 50.3-78.6% of the
administered dose.  Unidentified metabolites accounted for 8.2-14.6% of
the administered dose, but each compound represented <5% of the
administered dose.  The total administered dose accounted for in the
analyzed excreta was 64.4-90.2%.

Parent compound accounted for 13.0-24.6% of the total radioactivity
eliminated, and was found in both urine and fecal extracts.  The
majority of the radioactivity was associated with a mercapturic acid
conjugate of hydroxyl-chlorobenzamide (15-5-26.2%), present in the
urine.  Other metabolites present at >5% of the administered dose were
identified, and included the cysteine and O-glucuronide conjugates of
chlorobenzamide (3.4-6.6%), the cysteine conjugate of
hydroxy-chlorobenzamide (1.9-12.4%), the O-sulfate conjugate of
dichlorobenzamide/thiomethyl-chlorobenzamide (5.4-13.8%), and
3-hydroxy-chlorobenzamide (2.7-7.3%; detected in the high dose study
only).

This metabolism study in the rat is classified acceptable/guideline and
satisfies the guideline requirement for a Tier 1 metabolism study [OPPTS
870.7485, OECD 417] in rats.

	870.7600	Dermal Absorption – Rat

In a dermal penetration study (MRID 46708638), [14C-Phenyl]-AE C638206
(Fluopicolide; 99.8% radiochemical purity; Batch No. SEL/1200) in a
commercial concentrate (or aqueous dilution of a concentrate for the low
dose) was applied to the skin of 5 male Sprague-Dawley rats/time
point/dose. The dose (1.43 or 659 μg/cm2 skin) was applied to 12 cm2
skin and removed after 8 hours.  The animals were sacrificed at 8, 24,
72, or 144 hours after application.  Additionally, 2 male rats/time
point/dose were treated similarly in a preliminary study and were
sacrificed at 24, 72, or 144 hours, except only 1 rat was treated with
the low dose in the 144 hour group.

Recovery of the applied dose was 91-109%.  The distribution profile of
radioactivity was qualitatively similar between the two dose groups.
The majority of the administered dose (41-69% of the low dose and 87-91%
of the high dose) was recovered from the swabs used to remove the test
compound from the skin after 8 hours of treatment.  A total of 56-81%
(low dose) or 92-95% (high dose) was considered not absorbed.  After 144
hours, only 2-7% remained at the dose site and was considered available
for absorption.  Estimates of dermal absorption were based on the sum of
urine + feces + cage wash + tissues + treated skin + stratum corneum.
Dermal absorption ranged from 3-8% (high dose) to 22-37% (low dose).  In
the main studies, dermal absorption was greatest at 24 hours after
application, but there was no clear evidence for increased dermal
absorption with time at either dose.  Although there was not a
time-dependent increase in total dermal absorption at either dose, there
was a time-dependent increase in absorption through the stratum corneum
at the low dose (but not the high dose).

This study is classified as acceptable/guideline and satisfies the
guideline requirements (OPPTS 870.7600; OECD none) for a dermal
penetration study in rats.

In a non-guideline in vitro dermal penetration study (MRID 46708637),
[14C-Phenyl]-AE C638206 (Fluopicolide; 99.8% radiochemical purity; Batch
No. SEL/1200) was applied to excised human and rat skin in a suspension
concentrate formulation (EXP 11120A) at 2 dose concentrations, 1.9 and
744 μg/cm2 skin.  Flow-through diffusion cells were prepared for each
skin type at each dose level (n=7/group).  Dermatomed membranes of
approximately 300 µm thickness were tested for permeability prior to
treatment.  Receptor fluid samples were collected each hour after
treatment for 24 hours.  At 8 hours after test compound application, the
skin was swabbed with a mild detergent solution.  After 24 hours, the
experiment was terminated, and the skin membranes were tape stripped.
The initial 2 tape strips were assumed to represent the residual
(non-absorbed) dose.  Subsequent tape strips, the remaining skin, and
the receptor fluid remaining in the cell and outlet tubing at the end of
the experiment were also assayed.  Radioactivity was determined by
liquid scintillation counting.  Results for 5-7 skin
samples/species/dose were reported.

Total recovery was 92.3-96.5%.  The total amounts of applied
radioactivity absorbed within 24 hours at the high dose level were
0.022% in humans and 0.172% in rats, while at low dose levels the
amounts absorbed were 1.454% in humans and 14.26% in rats.  Therefore,
the amount of radioactive material absorbed was 7.8 times greater for
rat skin than for human skin at the high dose level, and 9.8 times
greater for rat skin than human skin at the low dose level.  These data
indicate that dermal penetration studies in the rat will provide a very
conservative estimate of dermal absorption in humans for risk
assessment.

This study is acceptable/non-guideline.

A.3.9	Special/Other Studies

	None.

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

	B.1	Metabolism Guidance and Considerations  tc  \l 2 "B.1	Metabolism
Guidance and Considerations"

Fluopicolide is a fungicide to be used on tuberous and  corm vegetables,
leafy vegetables (except Brassica), fruiting vegetables, cucurbit
vegetables, grapes, turf, and ornamental plants.   Tolerances have been
proposed for these crops and the rotational crop wheat.  Four foliar
applications are to be made to cucurbit vegetables, fruiting vegetables,
grapes, leafy vegetables, potatoes, and sweet potatoes at the maximum
seasonal application rate of 0.34-0.375 lb ai/A.  Minimum retreatment
intervals of 7-12 days and a preharvest interval of 2-21 days are to be
observed.

2,6-Dichlorobenzamide (BAM; AE C653711) is a metabolite and/or
environmental degradate of both fluopicolide and dichlobenil.  BAM is a
minor metabolite/degradate of fluopicolide.  BAM is included in the
tolerance expression for dichlobenil because it is a major
metabolite/degradate of dichlobenil.

HED (Paula Deschamp, Amelia Acierto, Nancy Dodd, Kelly O’Rourke, and
Myron Ottley) and EFED (Thuy Nguyen and James Lin) met on April 12, 2007
to determine the residues to include in the drinking water risk
assessment.  It was determined based on two aerobic soil metabolism
studies that the residues to be included in the drinking water risk
assessment are parent fluopicolide and the metabolite/degradate BAM.
BAM was a major metabolite/degradate, present at levels up to 40%.

HED has determined that the residue of concern for the tolerance
expression in the domestic primary plants (cucurbit vegetables, fruiting
vegetables, grapes, leafy vegetables, and tuberous and corm vegetables)
is fluopicolide (parent) as an indicator of combined residues of
fluopicolide and its metabolite 2,6-dichlorobenzamide.  For the risk
assessment, the residues of concern in the domestic primary plants
except tuberous and corm vegetables are fluopicolide (parent) and
2,6-dichlorobenzamide (BAM).  For tuberous and corm vegetables, the
residues of concern for the risk assessment are fluopicolide (parent),
BAM, and 3-chloro-5-trifluoromethylpyridine-2-carboxylic acid (PCA).

As determined by HED, the residue of concern for the tolerance
expression for rotational crops is fluopicolide (parent) as an indicator
of combined residues of fluopicolide and its metabolite
2,6-dichlorobenzamide.  The residues of concern for the risk assessment
are fluopicolide (parent) and BAM for all rotational crops except the
grain of cereal grains used as human food.  The residues of concern for
the risk assessment for the grain portion of cereal grain rotational
crops used as human food are fluopicolide (parent), BAM, PCA, and
3-methylsulfinyl-5-fluoromethylpyridine-2-carboxylic acid (P1X; AE
1344122).

The residues of concern in livestock commodities are tentative since
additional information is needed to support the ruminant and poultry
metabolism studies.  Pending submission of additional data, HED has
tentatively determined that the residue of concern in livestock
commodities for a tolerance expression is 2,6-dichlorobenzamide (BAM).
For the risk assessment, the residues of concern in livestock
commodities have been tentatively determined to be fluopicolide (parent)
and BAM.

B.2	Tabular Summary of Fluopicolide and its Metabolites and Degradates
tc  \l 2 "B.2	Tabular Summary of Fluopicolide and its Metabolites and
Degradates"

	Table B.2    Summary of Fluopicolide and its Metabolites and Degradates

Chemical Name (other names in parenthesis)

Matrix	Percent TRR (PPM) 1	Structure

Matrices - Major Residue, >10%TRR	Matrices - Minor Residue, <10%TRR

	2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl]-benza
mide

(fluopicolide)

(AE C638206)	Primary Crops:

	Grapes (fruit)	87.4 - 91.2%

(0.910 - 1.15 ppm)

	Lettuce

(mature leaves)	95.9 – 96.4%

(12.84 - 13.98 ppm)

Potato (mature tuber)	51.1 – 70.2%

(0.037 - 0.041 ppm)

	Rotational Crops (29-day PBI):

Lettuce	11.1- 35.8%

(0.108- 0.112 ppm )

	Radish top	24.5- 51.1%

(1.072- 1.644 ppm)

	Radish root	41.1- 47.9%

(0.048- 0.069 ppm)

	Wheat forage	33.7- 36.6%

(1.445- 1.812 ppm)

	Wheat grain	27.3%

(0.043 ppm)	1.8%

(0.046 ppm)

Wheat straw	23.1- 34.9%

(2.462- 3.132 ppm)

	Rotational Crops (365-day PHI):

Lettuce	41.5%

(0.024 ppm)	2.1%

(0.013 ppm)

Radish top	25.2%

(0.106 ppm)	3.8%

(0.076 ppm)

Radish root	24.2- 55.8%

(0.009-0.018 ppm)

	Wheat forage	27.8%

(0.068 ppm)	4.8%

(0.042 ppm)

Wheat grain

2.9- 7.3%

(0.004- 0.005 ppm)

Wheat straw	27.5%

(0.277 ppm)	7.2%

(0.172 ppm)

Ruminants:

Fat	73.4- 76.3%

(0.0312- 0.034 ppm)

	Kidney

1.0- 1.8%

(0.003, 0.003  ppm)

Liver

0.9- 2.9%

(0.0055- 0.013 ppm)

Milk	28.6%

(0.0054 ppm)

	Muscle

2.9%

(0.0007 ppm)

Poultry:

Egg white

2.5%

(0.001ppm)

Egg yolk	10.5- 11%

(0.005- 0.017 ppm)

	Fat	15.6%

(0.004 ppm)	6%

(0.004 ppm)

	2,6-dichlorobenzamide

(BAM)

(AE C653711)

	Primary Crops:

	Grapes (fruit)

2.0%

(0.026 ppm)

Lettuce

0.9%

(0.112 ppm)

Potato	25.4%

(0.021 ppm)

Rotational Crops (29-day PBI):

Lettuce	81.2%

(0.822 pm)

	Radish top	65.3%

(4.381 ppm)

	Radish root	43.2%

(0.062 ppm)

	Wheat forage

6.3%

(0.312  ppm)

Wheat grain

3.6%

(0.006 ppm)

Wheat straw

3.4%

(0.461 ppm)

Rotational Crops (365-day PHI):

Lettuce	87.0%

(0.539 ppm)

	Radish top	87.5%

(1.755 ppm)

	Radish root	60.9%

(0.022 ppm)

	Wheat forage	14.8%

(0.128 ppm)

	Wheat grain	17.9%

(0.010 ppm)

	Wheat straw

5.1%

(0.121 ppm)

Ruminants:

Milk

3.9%

(0.0007 ppm)

Poultry:

Liver	37%

(0.361 ppm)

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

(PCA)

(AE C657188)	Primary Crops:

	Grapes (fruit)

2.3%

(0.024 ppm)

Lettuce

0.6%

(0.078 ppm)

Potato	12.0%

(0.007 ppm)

	Rotational Crops (29-day PBI):

Lettuce	17.4%

(0.053 ppm)

	Radish top	10.4%

(0.217 ppm)

	Radish root	33.5%

(0.039 ppm)

	Wheat forage	43.0%

(1.844 ppm)

	Wheat grain	69.6%

(1.809 ppm)

	Wheat straw

7.0%

(0.494 ppm)

Rotational Crops (365-day PHI):

Lettuce	11.8%

(0.007 ppm)

	Radish top	27.1%

(0.114 ppm)

	Radish root	10.0%

(0.003 ppm)

	Wheat forage

8.2%

0.020 ppm)

Wheat grain	14.2%

(0.025 ppm)

	Wheat straw

4.1%

(0.042 ppm)

	2,6-dichloro-N-[(3-chloro-5-trifluoromethylpyridin-2-yl)methyl]-3-hydro
xybenzamide

(AE C643890)	Primary Crops:

	Grapes (fruit)

0.2%

(0.002 ppm)

Potato

1.7- 2.4%

(0.001-0.003 ppm)

Rotational Crops(29-day PBI):

Wheat forage

1.4, <1.5%

(0.060, <0.074 ppm)

Wheat grain	13.1%

(0.021 ppm)

	Rotational Crops (365-day PHI):

Kidney

6.8%

(0.0207 ppm)

2.6% *

(0.005 ppm)*

Liver

1.6%

(0.0105 ppm)

4.0%*

(0.018 ppm)*

Poultry:

Liver

3.1%**

(0.030 ppm)**

	2,6-dichloro-3-hydroxybenzamide

(3-OH-BAM)

(BAM-OH)

(AE C657378)

	Rotational Crops (29-day PBI):

	Wheat forage	32.7%

(1.619 ppm)

	Wheat straw	13.6%

(1.844 ppm)

	Rotational Crops (365-day PBI):

Wheat forage	59.3%

(0.513ppm)

	Wheat grain	24.5%

(0.013 ppm)

	Wheat straw	28.0%

(0.663 ppm)

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

(P1X)

(AE 1344122)

	Rotational Crops (29-day PBI):

	Lettuce	13.0%

(0.039 ppm)

	Radish top

3.3%

(0.069 ppm)

Radish root

9.6%

(0.011 ppm)

Wheat forage

3.8%

(0.163 ppm)

Wheat grain	13.1%

(0.341 ppm)

	Wheat straw

7.7%

(0.544 ppm)

Rotational Crops (365-day PHI):

Lettuce

7.8%

(0.005 ppm)

Radish top

5.1%

(0.022 ppm)

Radish root

5.3%

(0.002 ppm)

Wheat forage	18.3%

(0.045 ppm)

	Wheat grain	64.9%

(0.116 ppm)

	Wheat straw	14.2%

(0.143 ppm)

3-chloro-5-(trifluoromethyl)-2-pyridinol

(AE B102859)	Rotational Crops (29-day PHI):

	Lettuce

5.3%

(0.016 ppm)

Radish top

4.8%

(0.100 ppm)

Rotational Crops (365-day PHI):

Lettuce

3.7%

(0.002 ppm)

Radish top

6.0%

(0.025 ppm)

Wheat forage

9.9%

(0.024 ppm)

	3-chloro-5-(trifluoromethyl)-2-pyridine carboxamide

(AE C653598)	Rotational Crops (365-day PHI):

	Lettuce

9.0%

(0.005 ppm)

Radish top

9.5%

(0.003 ppm)

Wheat forage

6.3%

(0.015 ppm)

Wheat straw

4.8%

(0.048 ppm)

	2,6-dichloro-N-[(3-chloro-5-trifluoromethyl-2-pyridyl)methyl]-4-hydroxy
benzamide

(AE 0712556)

	Ruminants:

	Kidney

3.3%

(0.0098 ppm)

Liver

1.2%

(0.0076 ppm)

Poultry:

Egg white	41.2%

(0.005)

	Egg yolk	15.9%]

(0.014 ppm)

	Fat	47.3%

(0.012 ppm)

	Liver

5.9%

(0.016 ppm)

	2,6-dichloro-N-{[3-chloro-5-(trifluoromethyl)pyridin-2-yl]methyl}-3-(me
thylsulfonyl)benzamide

(Metabolite 1)	Poultry:

	Egg white	51%

(0.022 ppm)

	Fat	38%

(0.023 ppm)

Hydroxy glucuronide of fluopicolide	Ruminants:

	Kidney

4.7%

(0.009 ppm)

Liver

4.9%

(0.022 ppm)

Poultry

	Dihydroxy glucuronide of fluopicolide	Ruminants:

	Kidney	10.0%

0.019 ppm

Hydroxy sulfate of fluopicolide	Ruminants:

	Kidney

5.2%***

(0.010 ppm)***

Liver

2.4%

(0.011 ppm)

Egg yolk

7.1%

(0.006 ppm)

Liver

1.0-1.4%

(0.003-0.004 ppm)

Check 46708519

	Dihydroxy sulfate of fluopicolide	Ruminants:

	kidney

Reported with hydroxysulfate above

Egg white	22.5%

(0.003 ppm)

	Egg yolk	34.0%

(0.015 ppm)

	Liver

1.9%

A (≈1x); 21-day PHI.

 Lettuce: MRID 46708520; two foliar applications for a total seasonal
rate of 0.36 lb ai/A (≈1x); 35-day PHI.

 Potato: MRID 46708521; two foliar applications for a total seasonal
rate of 0.36 lb ai/A (≈1x); 20-day PHI.

 Rotational Crops: MRID 46708546; bare soil treatment at 0.36 lb ai/A
(≈1x) and PBIs of 29 or 365 days.

 Ruminants: MRIDs 46708514 and 46708518; cows were dosed 7 days at 10 or
10.55 ppm.

 Poultry: MRIDs 46708515 and 46708519; hens were dosed 14 days at 10 or
10.7 ppm.

 Rats: MRID 46474242; one oral dose of [14C-2,6-pyridyl]-AE C638206 at
10 mg/kg bw.  The major metabolites in urine and feces were oxidative
N-dealkylation cleavage products.

 Water:

*AE C643890/ AE 0712556

**Also includes AE 0608000

*** Also includes dihydroxy sulfate of fluopicolide

Appendix C:  Tolerance Assessment Summary and Table

HED is recommending a revision of the proposed tolerance expression for
fluopicolide in/on plants to address issues of quantifiable residues
2,6-dichlorobenzamide (BAM) in/on RACs resulting from fluopicolide
application. HED has determined that the terminal residue of concern in
cucurbit vegetable, fruiting vegetable, grape, leafy vegetable, and
tuberous and corm vegetable commodities for the tolerance expression is
fluopicolide
[2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl]benzam
ide] as an indicator of combined residues of fluopicolide and its
metabolite 2,6-dichlorobenzamide.

No Codex, Canadian, or Mexican MRLs have been established for
fluopicolide.

-

4

:

<

\

]

_

`

i

Ã

Ë

Ì

-

=

_

`

†

£

Ã

Ä

Ë

Ì

ç

ༀ킄ᄂ킄㄂$葞ː葠ː摧爧Ø

'

(

,

-

6

9

>

?

Q

Y

\

]

e

f

q

r

z

{

†

‡

Œ

°

h~+

hE

ô

j¸

j;

j¬

j/

j

h«4

h¢x

㄀$摧䙵[

#

©

©

 hK

  hK

hZ

š

}

š

}

š

}

š

}

혈Fᴃ騀퐋괜$紆

ᴃ騀퐋괜$紆

š

}

š

}

š

}

š

}

혈Fᴃ騀퐋괜$紆

h›

h“

@

÷ñçÝÍÀÍµÝ«¤ñžñ˜‹~‹nñ«gñ«ñ]«TñM

 h

  h

 h

  h

 h

  h

 h

  h

h…

h…

h…

h…

摧᳞:

摧罕¸

ÓÜÓzñøèâèÜèâ

h…

h…

摧අ}

摧᳞:

摧罕¸

h…

h…

摧අ}

摧᳞:

摧罕¸

h…

h

hÝ

똁

똁

摧梏

摧Ṋ

똁

㄀$摧夝#

hî

 hî

 hî

hî

h

hÝ

h

¶

¶

l

n

h

萏Ғ萑ﭮ葞Ғ葠ﭮ摧⒃í

  h

h]

 h]

h]

kd

‘

’

<

)

E

V

’

Í

µ

µ

µ

µ

µ

µ

µ

µ

µ

µ

µ

µ

µ

µ

愀Ĥ摧煟l

愀Ĥ摧煟l

愀Ĥ摧煟l

愀Ĥ摧煟l

愀Ĥ摧煟l

愀Ĥ摧紺>

愀Ĥ摧紺>

愀Ĥ摧紺>

愀Ĥ摧紺>

愀Ĥ摧紺>

@

摧⇳

hó!

hó!

hó!

hó!

hó!

hó!

hó!

hó!

hó!

hó!

hó!

hó!

hó!

hó!

hó!

hó!

hó!

摧⇳

hó!

hó!

 hó!

hp

 hp

hp

hp

¶

¶

¶

¶

¶

¶

¶

¶

ÿ瑹嚩g$̀Ĥ옍)

"̀Ĥ옍)

摧嚩g$̀Ĥ옍)

摧嚩g$̀Ĥ옍)

옍)

摧嚩g$̀Ĥ옍)

$̀Ĥ옍)

옍)

옍)

$̀Ĥ옍)

愀Ĥ摧嚩g"̀Ĥ옍)

"̀Ĥ옍)

愀Ĥ摧嚩g$̀Ĥ옍)

摧嚩g$̀Ĥ옍)

옍)

摧嚩g$̀Ĥ옍)

ÿ瑹嚩g$̀Ĥ옍)

옍)

摧嚩g$̀Ĥ옍)

愀Ĥ摧嚩g"̀Ĥ옍)

摧嚩g$̀Ĥ옍)

愀Ĥ摧嚩g"̀Ĥ옍)

摧嚩g$̀Ĥ옍)

$̀Ĥ옍)

옍)

옍)

摧嚩g$̀Ĥ옍)

愀Ĥ摧嚩g"̀Ĥ옍)

摧嚩g$̀Ĥ옍)

愀Ĥ摧嚩g"̀Ĥ옍)

晆䆊$̀Ĥ옍)

옍)

ô

Î"`	ô

ô

Î" 	ô

愀Ĥ摧嚩g$̀Ĥ옍)

摧嚩g$̀Ĥ옍)

摧嚩g$̀Ĥ옍)

愀Ĥ摧嚩g$̀Ĥ옍)

摧嚩g$̀Ĥ옍)

摧嚩g$̀Ĥ옍)

摧嚩g$̀Ĥ옍)

옍)

Ȑ脈栖᝭

ș脈栖᝭

ȟ脈栕涯`栖᝭

栕涯`栖᝭

㄀$摧圶

Ȓ脈栖圶

栖圶

h

h

h

h

h6W

h

h

h

h

h

h

h

h:

$̀Ĥ옍)

 h$'

"̀Ĥ옍)

$̀Ĥ옍)

@

晆$̀Ĥ옍)

"̀Ĥ옍)

$̀Ĥ옍)

$̀Ĥ옍)

$̀Ĥ옍)

$̀Ĥ옍)

܀

 h$'

$̀Ĥ옍)

"̀Ĥ옍)

愀Ĥ摧嚩g$̀Ĥ옍)

kd$

$̀Ĥ옍)

愀Ĥ摧嚩g"̀Ĥ옍)

摧嚩g$̀Ĥ옍)

摧嚩g$̀Ĥ옍)

$̀Ĥ옍)

@

@

h

h

h

h

0

1

L

M

-

/

1

K

s

¯

´

>

œ

¯

Á

Õ

ô

ý

þ

 h

Õ

Ö

þ

@

h

h

h

h

h

  h

h

옍)

옍)

@

$

@

$

@

$

@

@

ô

@

@

@

@

@

@

@

@

摧㦾

摧㦾

摧㦾

摧㦾

摧㦾

摧㦾

摧㦾

摧㦾

摧㦾

摧㦾

摧㦾

摧㦾

摧㦾

摧㦾

 h„

~

&

u

€

@

@

  hû

@

@

@

\

\

kd

\

܀ā 将

㐀ۖĀ̊e攃昀Ĵ瑹➟pĀ

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

蘆ܐā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

蘆ܐā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

蘆ܐā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

蘆ܐā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

\

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

܀ā 将

	”

܀ā 将

܀ā 将

	”

܀ā 将

\

܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

蘆ܐā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

蘆ܐā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

\

\

\

\

\

\

\

	”

\

	”

\

\

\

\

\

\

\

\

\

\

\

ꀆ܅ā܀ā܀ā܀ā 将

\

ꀆ܅ā܀ā܀ā܀ā 将

\

kdC

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

蘆ܐā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

ꀆ܅ā܀ā܀ā܀ā 将

\

ꀆ܅ā܀ā܀ā܀ā 将

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

\

h¬

hf

ﰀ

ﱧ

ﱴ

ﲵ

ﴫ

ﵡ

ﵦ

﷈

﷏

ﷳ

ﻘ

ﻙ

＂

＃

Ｅ

Ｍ

￦

limit of quantitation of the method will be needed to register crops
with associated livestock feeds.  For a future risk assessment including
crops with associated livestock feeds, the residues of concern in
livestock commodities have been tentatively determined to be parent
fluopicolide and BAM.

Pending submission of the requested storage stability data/information,
adequate field trial data are available for tuberous and corm vegetables
(subgroup 1C and 1D), leafy vegetables (except Brassica, group 4),
fruiting vegetables (group 8), cucurbit vegetables (group 9), and
grapes.  The available field trial data will support tolerances for
residues of fluopicolide in/on grape at 2.0 ppm, the cucurbit vegetable
group at 0.50 ppm, the fruiting vegetable group at 1.6 ppm, the leafy
vegetable, except brassica, group at 25 ppm, and the tuberous and corm
vegetable subgroup at 0.02 ppm.  Because the majority of residues in
potatoes were below the LOQ, the tolerance spreadsheet in the Agency’s
Guidance for Setting Pesticide Tolerances Based on Field Trial Data was
not utilized for determining an appropriate tolerance level for the
tuberous and corm vegetable subgroup.  The data indicate that the
proposed tolerances of 0.8 ppm and 20 ppm for the fruiting vegetable and
leafy vegetable crop groups are too low; increased tolerances of 1.6 ppm
and 25 ppm are needed.

Pending submission of the requested storage stability information,
adequate extensive field rotational crop data are available for wheat
forage, hay, grain, and straw.  The available field trial data will
support tolerances for indirect or inadvertent residues of fluopicolide
in/on wheat forage at 0.20 ppm, wheat hay at 0.50 ppm, wheat grain at
0.02 ppm, and wheat straw at 0.50 ppm.  For wheat grain, the majority of
residues were below the LOQ; therefore, the tolerance spreadsheet was
not used for wheat grain.

Adequate processing data for grapes, potatoes, tomatoes, and wheat are
available pending submission of the requested storage stability
data/information.  The available processing data indicate that residues
of fluopicolide are not likely to concentrate in grape juice, in potato
chips and flakes, or in wheat flour.  Residues of fluopicolide were
found to concentrate in raisins, processed potato waste (wet peels),
tomato paste and puree, and wheat milled byproducts (bran, germ,
middlings, and shorts).  The processing data indicate that the proposed
tolerance of 6 ppm for raisins is appropriate.  In addition, a tolerance
for processed potato waste must be proposed at 0.05 ppm, and tolerances
for wheat milled byproducts and aspirated grain fractions must be
proposed at 0.07 ppm.  Separate tolerances for tomato processed
commodities are not needed as residues in these commodities are not
expected to exceed the recommended tolerance of 1.6 ppm for the fruiting
vegetable group.

The available cattle feeding study data indicate that tolerances for
ruminant and swine commodities are not needed to support the requested
fluopicolide uses.  The need for tolerances for poultry commodities will
be determined after the required poultry metabolism data have been
submitted.

The proposed tolerances should be revised to reflect the recommended
tolerance levels and correct commodity definitions as specified in Table
C.1.  Tolerances to be established when rotational crop and livestock
issues are resolved are specified in Table C.2.

Table C.1. 	Tolerance Summary for Fluopicolide.

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments;
Correct Commodity Definition

Tolerances to be established under “(a) General” (1):

Tuberous and corm vegetables subgroup 1C

Arracacha 	0.02	0.02	Vegetable, tuberous and corm, except potato,
subgroup 1D

Arrowroot 	0.02

Artichoke, Chinese 	0.02

Artichoke, Jerusalem 	0.02

Canna, edible 	0.02

Cassava, bitter and sweet 	0.02

Chayote (root) 	0.02

Chufa 	0.02

Dasheen 	0.02

Ginger 	0.02

Leren 	0.02

Sweet potato 	0.02

Tanier 	0.02

Turmeric 	0.02

Yam bean 	0.02

Yam, true 	0.02

Vegetable, leafy, except brassica, group 4

Head Lettuce 	20	25	Vegetable, leafy, except brassica, group 4

Leaf Lettuce 	20

Spinach 	20

Arugula 	20

Chervil 	20

Chinese spinach 	20

Corn salad 	20

Dandelion 	20

Dock (sorrel) 	20

Edible chrysanthemum 	20

Endive 	20

Garden cress 	20

Garden purslane 	20

Garland Chrysanthemum 	20

New Zealand spinach 	20

Orach 	20

Parsley 	20

Red chicory 	20

Upland cress 	20

Vine spinach 	20

Winter purslane 	20

Cardoon 	20

Celery 	20

Celtuce 	20

Chinese celery 	20

Fennel 	20

Rhubarb 	20

Swiss chard 	20

Vegetable, fruiting, group 8

Tomato/Cherry tomato 	0.8	1.6	Vegetable, fruiting, group 8

Sweetpepper 	0.8

Bell pepper 	0.8

Chili pepper 	0.8

Cooking pepper 	0.8

Pimiento 	0.8

Eggplant 	0.8

Groundcherry 	0.8

Pepino 	0.8

Tomatillo 	0.8

Vegetable, cucurbit, group 9

Cantaloupe 	0.4	0.50	Vegetable, cucurbit, group 9

Citron melon 	0.4

Muskmelon 	0.4

Watermelon	0.4

Chayote (fruit) 	0.4

Chinese waxgourd 	0.4

Cucumber 	0.4

Gherkin 	0.4

Gourd, edible 	0.4

Momordica spp 	0.4

Pumpkin 	0.4

Squash, summer 	0.4

Squash, winter 	0.4

Other

Grape 	2	2.0

	Raisins 	6	6.0	Grape, raisin

Table C.2.  Tolerance Summary for Fluopicolide (To be Established when
All Deficiencies are Resolved).

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments;
Correct Commodity Definition

Tolerances to be established under “(a) General” (1):

Tuberous and corm vegetables subgroup 1C

Potato 	0.02	0.02	Vegetable, tuberous and corm, subgroup 1C

Other

Potato, processed potato waste	None proposed	0.05

	Tolerances to be established under “(a) General” (2):

Cattle fat	None proposed	0.05 ppm	Cattle, fat

Cattle meat	None proposed	0.02 ppm	Cattle, meat

Cattle meat byproducts	None proposed	0.05 ppm	Cattle, meat byproducts

Goat fat	None proposed	0.05 ppm	Goat, fat

Goat meat	None proposed	0.02 ppm	Goat, meat

Goat meat byproducts	None proposed	0.05 ppm	Goat, meat byproducts

Horse fat	None proposed	0.05 ppm	Horse, fat

Horse meat	None proposed	0.02 ppm	Horse, meat

Horse meat byproducts	None proposed	0.05 ppm	Horse, meat byproducts

Milk	None proposed	0.01 ppm	Milk

Sheep fat	None proposed	0.05 ppm	Sheep, fat

Sheep meat	None proposed	0.02 ppm	Sheep, meat

Sheep meat byproducts	None proposed	0.05 ppm	Sheep, meat byproducts

Tolerances to be established under “(d) Indirect or inadvertent
residues”:

Wheat forage 	0.2	0.20	Wheat, forage

Wheat grain 	0.02	0.02	Wheat, grain

Wheat hay 	0.5	0.50	Wheat, hay

Wheat straw 	0.5	0.50	Wheat, straw

Wheat, milled byproducts	None proposed	0.07

	Wheat, aspirated grain fractions	None proposed	0.07

	 TC \l1 "Appendix C:  Tolerance Assessment Summary and Table

Appendix D:  	Review of Human Research TC \l1 "Appendix D:  Review of
Human Research

This risk assessment relies in part 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.

Klonne, D. (1999) Integrated Report for Evaluation of Potential
Exposures to Homeowners and Professional Lawn Care Operators Mixing,
Loading, and Applying Granular and Liquid Pesticides to Residential
Lawns:  Lab Project Number:  OMA005: OMA001: OMA002.  Unpublished study
prepared by Riceerca, Inc., and Morse Laboratories.  2213 p. (MRID
44972201).

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.

഍ഄ഍഍倍条 景†–啎偍䝁卅尠牡扡捩尠䕍䝒
䙅剏䅍⁔ㄔ㠲ക഍慐敧ጠ倠䝁⁅ㄔᔰ漠–啎偍䝁卅ᐠ
㈱ᔸ഍഍഍慐敧
漠ጠ丠䵕䅐䕇⁓⩜愠慲楢⩜䴠剅䕇但䵒呁ᐠ㈱ᔸ഍
഍഍倍条 景†–啎偍䝁卅尠牡扡捩尠䕍䝒䙅剏
䅍⁔ㄔ㠲ക഍慐敧ጠ倠䝁⁅㜔ᔰ漠–啎偍䝁卅ᐠ㈱ᔸ
഍഍഍慐敧
漠ጠ丠䵕䅐䕇⁓⩜愠慲楢⩜䴠剅䕇但䵒呁ᐠ㈱ᔸ഍
഍഍倍条 景†–啎偍䝁卅尠牡扡捩尠䕍䝒䙅剏
䅍⁔ㄔ㠲ക഍慐敧ጠ倠䝁⁅ㄔㄲ―景ጠ丠䵕䅐䕇⁓ㄔ㠲
ക倍条–䅐䕇ᐠ㌷―景ጠ丠䵕䅐䕇⁓ㄔ㠲ക倍条–
䅐䕇ᐠ㈱ᔸ漠–啎偍䝁卅ᐠ㈱ᔸ഍č഍


[Federal Register: August 1, 2007 (Volume 72, Number 147)]
[Rules and Regulations]
[Page 41891-41894]
[DOCID:fr01au07-6]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2005-MD-0002; FRL-8447-6]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Clarification of Visible Emissions Exceptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving a State Implementation Plan (SIP) revision

submitted by the State of Maryland. This revision consists of
clarifications to the exception provisions of the Maryland visible
regulations.

DATES: Effective Date: This final rule is effective on August 31, 2007.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2005-MD-0002. All documents in the docket are listed
in the http://www.regulations.gov Web site. 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 http://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
Maryland Department of the Environment, 1800 Washington Boulevard,
Suite 705, Baltimore, Maryland 21230.

FOR FURTHER INFORMATION CONTACT: Linda Miller,<PHONE_NUMBER>, or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On December 1, 2003, the State of Maryland submitted a formal SIP
revision (03-10) that clarifies Maryland's federally-approved
general visible emissions (VE) regulations, including those related to
specific source categories. The revised language will ensure that
sources correctly interpret the exception provisions provided in those
regulations. On April 26, 2005 (70 FR 21337), EPA published a direct
final rule (DFR) approving revisions to Maryland's SIP pertaining to
its VE regulations.
    An explanation of the CAA's requirements and EPA's rationale for
approving this SIP revision were provided in the DFR and will not be
restated here. In accordance with direct final rulemaking procedures,
on April 26, 2005 (70 FR 21387), EPA also published a companion notice
of proposed rulemaking (NPR) for this SIP revision inviting interested
parties to comment on the DFR. Timely adverse comments were submitted
on EPA's April 26, 2005 DFR.
    On June 27, 2005 (70 FR 36844), due to the receipt of adverse
comments submitted in response to the DFR, EPA published a withdrawal
of the DFR. A summary of those comments and EPA's responses are
provided in Section II of this document.

II. Public Comment and EPA Response

    Comment: EPA received the same comment on behalf of two commenters.
The commenters state that the federal new source performance standards
(NSPS) and national emission standards for hazardous air pollutants
(NESHAPs) regulations allow exceedance of their respective opacity
standards for up to three hours per occurrence during periods of
startup, shutdown and repair. These federal regulations require the
installation of continuous opacity monitors (COM). The commenters claim
that air pollution control equipment on certain municipal waste
combustion (MWC) sources cannot achieve the visible emissions exception
requirements as stated in Maryland's clarified visible emissions rule
due to the occasional formation of ``condensed'' plumes after emissions
exit the stack, as a result of upset conditions that may occur during
the operation of emission control devices used to reduce nitrogen
oxides (NOX) emissions. The commenters believe that
Maryland's regulations regarding VE exceptions should be revised to be
consistent with the existing federal NSPS and NESHAP regulations for
MWCs.
    Response: EPA understands that the VE requirements established in
Maryland's regulations differ from those established in the NSPS and
NESHAP regulations that currently apply to MWCs. States have frequently
used VE limits as part of their efforts to attain the NAAQS. Under the
CAA's bifurcated scheme, the State is responsible for choosing how a
source must be regulated for purposes of attaining the NAAQS and EPA's
role is limited in reviewing the State's choice to ensure it meets the
minimum statutory requirements. Here, the commenter is not claiming
that the regulations do not meet the statutory minimum, but rather that
Maryland is seeking to require more than the minimum statutory
requirements. The CAA is based upon ``cooperative federalism,'' which
contemplates that each State will develop its own SIP, and that States
retain a large degree of flexibility in choosing which sources to
control and to what degree. EPA must approve a State's plan if it meets
the ``minimum requirements of the CAA. Union Elec. Co. v. EPA, 427 U.S.
246, 264-266 (1976).

III. Final Action

    EPA is approving revisions to the Maryland VE exception provisions
as a revision to the Maryland SIP.

IV. Statutory and Executive Order Reviews

A. General Requirements

    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 approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this 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 (Pub. L. 104-4). This rule also does not
have tribal implications because it will 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 action also does not have Federalism implications because it does
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 approves a state rule implementing a Federal
requirement, and does not alter the relationship or the distribution of
power and responsibilities established in the Clean Air Act. This 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 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. 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 rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

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 October 1, 2007. 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 revisions to the Maryland
regulations which clarify the visible emissions exception provisions
may not be challenged later in proceedings to enforce its requirements
may not be challenged later in proceedings to enforce its requirements.
(See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Particulate
matter, Reporting and recordkeeping requirements.

    Dated: July 19, 2007.
William T. Wisniewski,
Acting Regional Administrator, Region III.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart V--Maryland

0
2. In Sec.  52.1070, the table in paragraph (c) is amended by revising
the entries for COMAR <IP_ADDRESS>, 10.18.08 (Title), <IP_ADDRESS>,
<IP_ADDRESS>, and <IP_ADDRESS> to read as follows:

Sec.  52.1070  Identification of plan.

* * * * *
    (c) EPA approved regulations.

                                                      EPA-Approved Regulations in the Maryland SIP
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Code of Maryland administrative                                 State
    regulations (COMAR) citation          Title/subject      effective date     EPA approval date     Additional explanation/citation at 40 CFR 52.1100
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                           26.11.06 General Emission Standards, Prohibitions, and Restrictions
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
<IP_ADDRESS> [Except: .02A(1)(e),     Visible Emissions.....        11/24/03  08/01/07 [Insert page   Revised paragraph <IP_ADDRESS>A(2).
 (1)(g), (1)(h), (1)(i)].                                                     number where the
                                                                              document begins].

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        10.18.08/26.11.08 Control of Incinerators
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
<IP_ADDRESS>/<IP_ADDRESS>............  Visible Emissions.....        11/24/03  08/01/07 [Insert page   Revised COMAR citation; revised paragraph
                                                                              number where the        <IP_ADDRESS>C.
                                                                              document begins].

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
              26.11.09 Control of Fuel-Burning Equipment and Stationary Internal Combustion Engines, and Certain Fuel-Burning Installations
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
<IP_ADDRESS>........................  Visible Emissions.....        11/24/03  08/01/07 [Insert page   Revised paragraph <IP_ADDRESS>A(3).
                                                                              number where the
                                                                              document begins].

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               26.11.10 Control of Iron and Steel Production Installations
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
<IP_ADDRESS>........................  Visible Emissions.....        11/24/03  08/01/07 [Insert page   Revised paragraph <IP_ADDRESS>A(2).
                                                                              number where the
                                                                              document begins].

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
 [FR Doc. E7-14773 Filed 7-31-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 237 (Monday, December 10, 2012)]
[Notices]
[Page 73489]
[FR Doc No: 2012-29657]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4089-DR; Docket ID FEMA-2012-0002]

Rhode Island; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Rhode Island (FEMA-4089-DR), dated November 3, 2012,
and related determinations.

DATES: Effective Date: November 10, 2012.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Rhode Island is hereby amended to include the
following area among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of November 3, 2012.

    Kent County for Public Assistance, including direct federal
assistance.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-29657 Filed 12-7-12; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: August 20, 2010 (Volume 75, Number 161)]
[Notices]
[Page 51455-51457]
[DOCID:fr20au10-42]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PF10-13-000]

Transcontinental Gas Pipe Line Company, LLC; Notice of Intent To
Prepare an Environmental Assessment for the Planned Mid-South Expansion
Project and Request for Comments on Environmental Issues

August 13, 2010.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Mid-South Expansion Project
(MSEP) involving construction and operation of facilities by
Transcontinental Gas Pipe Line Company, LLC (Transco) in Coosa,
Randolph, Dallas, and Marengo Counties, Alabama; Gaston, Rowan,
Davidson, and Cleveland Counties, North Carolina; Walton, Coweta, and
Henry Counties, Georgia; and Spartanburg County, South Carolina. This
EA will be used by the Commission in its decision-making process to
determine whether the project is in the public convenience and
necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the project. Your input will help the Commission staff
determine what issues need to be evaluated in the EA. Please note that
the scoping period will close on September 13, 2010.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives are asked to notify their constituents of this planned
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, you may be contacted
by a pipeline company representative about the acquisition of an
easement to construct, operate, and maintain the planned facilities.
The company would seek to negotiate a mutually acceptable agreement.
However, if the project is approved by the Commission, that approval
conveys with it the right of eminent domain. Therefore, if easement
negotiations fail to produce an agreement, the pipeline company could
initiate condemnation proceedings where compensation would be
determined in accordance with state law.
    A fact sheet prepared by the FERC entitled ``An Interstate Natural
Gas Facility On My Land? What Do I Need To Know?'' is available for
viewing on the FERC Web site (http://www.ferc.gov). This fact sheet
addresses a number of typically-asked questions, including the use of
eminent domain and how to participate in the Commission's proceedings.

Summary of the Planned Project

    Transco is proposing to construct and operate five new pipeline
loops,\1\ construct one new compressor station, add compression at two
existing compressor stations, and perform other modifications to five
compressor stations. The MSEP would provide about 451 million standard
cubic feet of natural gas per day to Transco's existing mainline system
from the Clean Energy LNG import terminal currently under construction
in Pascagoula, Mississippi, with existing capacity on Transco's Mobile
Bay Lateral, down to existing Compressor Station 85. According to
Transco, its project would expand delivery capacity on its existing
pipeline system to growing markets in the east as far downstream as
Rockingham County, North Carolina.
---------------------------------------------------------------------------

    \1\ A pipeline loop is constructed parallel to an existing
pipeline to increase capacity.
---------------------------------------------------------------------------

    The MSEP would consist of the following facilities:
 Five pipeline loops located in Coosa and Randolph Counties,
Alabama, and Gaston, Rowan and Davidson Counties, North Carolina;
 One new compressor station, Station 95, to be located in
Dallas County, Alabama;
 Additional new compression at two existing compressor
stations:
    [cir] Station 90 in Marengo County, Alabama; and
    [cir] Station 125 in Walton County, Georgia;
 Modifications at the following existing compressor stations:
    [cir] Station 105 in Coosa County, Alabama;
    [cir] Station 115 in Coweta County, Georgia;
    [cir] Station 120 in Henry County, Georgia;
    [cir] Station 140 in Spartanburg County, South Carolina; and
    [cir] Station 145 in Cleveland County, North Carolina.

    The planned loops would be constructed with 42-inch-diameter steel
pipe and would have a combined total length of about 22.6 miles.

    The general location of the project facilities is shown in appendix
1.\2\
---------------------------------------------------------------------------

    \2\ The appendices referenced in this notice are not being
printed in the Federal Register. Copies of appendices were sent to
all those receiving this notice in the mail and are available at
http://www.ferc.gov using the link called ``eLibrary'' or from the
Commission's Public Reference Room, 888 First Street NE.,
Washington, DC 20426, or call<PHONE_NUMBER>. For instructions on
connecting to eLibrary, refer to the last page of this notice.
---------------------------------------------------------------------------

Land Requirements for Construction

    Construction of the planned facilities would disturb approximately
287.9 acres of land for the aboveground facilities and the pipeline.
Following construction, approximately 144.6 acres would be maintained
for permanent operation of the project's facilities; the remaining
acreage would be restored and allowed to revert to former uses. The
entire planned pipeline route either parallels or would be located
within existing pipeline, utility, or road rights-of-way.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\3\ to discover and address concerns the public may have about
proposals. This process is referred to as scoping. The main goal of the
scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. All comments
received will be considered during the preparation of the EA.
---------------------------------------------------------------------------

    \3\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
---------------------------------------------------------------------------

    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the planned project under these
general headings:

 Geology and soils;
 land use;
 water resources, fisheries, and wetlands;
 cultural resources;
 vegetation and wildlife;
 air quality and noise;
 endangered and threatened species; and
 public safety.

    We will also evaluate possible alternatives to the planned project
or portions of the project, and make recommendations on how to lessen
or avoid impacts on the various resource areas.
    Although no formal application has been filed, we have already
initiated our NEPA review under the Commission's pre-filing process.
The purpose of the pre-filing process is to encourage early involvement
of interested stakeholders and to identify and resolve issues before an
application is filed with the FERC. As part of our pre-filing review,
we have begun to contact some Federal and State agencies to discuss
their involvement in the scoping process and the preparation of the EA.
    Our independent analysis of the issues will be presented in the EA.
The EA will be placed in the public record and, depending on the
comments received during the scoping process, may be published and
distributed to the public. A comment period will be allotted if the EA
is published for review. We will consider all comments on the EA before
we make our recommendations to the Commission. To ensure your comments
are considered, please carefully follow the instructions in the Public
Participation section beginning on page 5.
    With this notice, we are asking agencies with jurisdiction and/or
special expertise with respect to environmental issues to formally
cooperate with us in the preparation of the EA. These agencies may
choose to participate once they have evaluated the proposal relative to
their responsibilities. Agencies that would like to request cooperating
agency status should follow the instructions for filing comments
provided under the Public Participation section of this notice.

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with applicable State Historic Preservation Office(s), and to solicit
their views and those of other government agencies, interested Indian
tribes, and the public on the project's potential effects on historic
properties.\4\ We will define the project-specific Area of Potential
Effects (APE) in consultation with the SHPO(s) as the project is
further developed. On natural gas facility projects, the APE at a
minimum encompasses all areas subject to ground disturbance (examples
include construction right-of-way, contractor/pipe storage yards,
compressor stations, and access roads). Our EA for this project will
document our findings on the impacts on historic properties and
summarize the status of consultations under section 106.
---------------------------------------------------------------------------

    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Historic
properties are defined in those regulations as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register for Historic
Places.
---------------------------------------------------------------------------

Currently Identified Environmental Issues

    We have already identified several issues that we think deserve
attention based on a preliminary review of the planned facilities and
the environmental information provided by Transco. This preliminary
list of issues may be changed based on your comments and our analysis.
 Cultural resources;
 Water resources, fisheries, and wetlands; and
 Threatened and endangered species.

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the project. Your comments should focus on
the potential environmental effects, reasonable alternatives, and
measures to avoid or lessen environmental impacts. The more specific
your comments, the more useful they will be. To ensure that your
comments are timely and properly recorded, please send your comments so
that they will be received in Washington, DC on or before September 13,
2010.
    For your convenience, there are three methods you can use to submit
your comments to the Commission. In all instances, please reference the
project docket number (PF10-13-000) with your submission. The
Commission encourages electronic filing of comments and has expert
eFiling staff available to assist you at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    (1) You may file your comments electronically by using the eComment
feature, which is located on the Commission's Web site at http://
www.ferc.gov under the link to Documents and Filings. An eComment is an
easy method for interested persons to submit brief, text-only comments
on a project;
    (2) You may file your comments electronically by using the eFiling
feature, which is located on the Commission's Web site at http://
www.ferc.gov under the link to Documents and Filings. With eFiling you
can provide comments in a variety of formats by attaching them as a
file with your submission. New eFiling users must first create an
account by clicking on ``eRegister.'' You will be asked to select the
type of filing you are

making. A comment on a particular project is considered a ``Comment on
a Filing''; or
    (3) You may file a paper copy of your comments at the following
address: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Room 1A, Washington, DC 20426.

Environmental Mailing List

    The environmental mailing list includes Federal, State, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
planned project.
    If the EA is published for distribution, copies will be sent to the
environmental mailing list for public review and comment. If you would
prefer to receive a paper copy of the document instead of the CD
version or would like to remove your name from the mailing list, please
return the attached Information Request (appendix 2).

Becoming an Intervenor

    Once Transco files its application with the Commission, you may
want to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are
included in the User's Guide under the ``e-filing'' link on the
Commission's Web site. Please note that the Commission will not accept
requests for intervenor status at this time. You must wait until a
formal application for the project is filed with the Commission.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (http://www.ferc.gov) using the eLibrary link. Click on
the eLibrary link, click on ``General Search'' and enter the docket
number, excluding the last three digits in the Docket Number field
(i.e., PF10-13). Be sure you have selected an appropriate date range.
For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at http://www.ferc.gov/EventCalendar/
EventsList.aspx along with other related information.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-20652 Filed 8-19-10; 8:45 am]
BILLING CODE 6717-01-P