AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

	OPEN MEETING

July 23, 2010

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ- OPP-2009-0378

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Scientific Issues related to the Comparative Adult and Juvenile
Sensitivity Toxicity Protocols for Pyrethroids

Please note that all times are approximate

(See note at the end of the Agenda)

		Friday, July 23, 2010

8:30 A.M.	Opening of Meeting and Administrative Procedures by Designated
Federal Official – Sharlene Matten, Ph.D., Designated Federal
Official, Office of Science Coordination and Policy, EPA

8:35 A.M.	Introduction and Identification of Panel Members –

	Steven Heeringa, Ph.D., Chair, FIFRA Scientific Advisory Panel

8:40 A.M.	Welcome and Opening Remarks – Tina Levine, Ph.D., Director,
Health Effects Division, Office of Pesticide Programs, EPA

9:00 A.M.	Regulatory Overview and Objectives – Edward Scollon, Ph.D.,

	Health Effect Division, Office of Pesticide Programs, EPA

10:00  A.M.	BREAK

10:15  A.M.	PUBLIC COMMENTS

11:15  A.M.	Charge Question 1

Auditory Startle Response or Acoustic Startle Reflex (ASR)

1.1      The auditory startle is a commonly used technique to assess
neurobehavioral effects in rats.  Auditory startle reflex is a motor
reflex characterized by a sequence of reflexive muscle movements
elicited by sudden and intense acoustic stimuli measured by a change in
motor output. The proposed reflex path is short, consisting of the
auditory nerve, posteroventral cochlear nucleus, the nucleus reticularis
pontis caudalis, and motor neurons in the spinal cord   ADDIN EN.CITE
<EndNote><Author>Davis</Author><Year>1982</Year><RecNum>306</RecNu
m><DisplayText>(Davis et al.
1982)</DisplayText><record><rec-number>306</rec-number><foreign-keys><ke
y app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">306</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>M
Davis</author><author>DS Gendelman</author><author>MD
Tischler</author><author>PM
Gendelman</author></authors></contributors><titles><title>a primary
acoustic startle circuit; lesion and stimulation
studies</title><secondary-title>J
Neurosci</secondary-title></titles><periodical><full-title>J
Neurosci</full-title></periodical><pages>791-805</pages><volume>6</volum
e><dates><year>1982</year></dates><urls></urls></record></EndNote
> (Davis et al. 1982) .  This mechanism is susceptible to a variety of
drugs and toxicants making the reflex a useful model of sensorimotor
reactivity across animal taxa, including rat and human   ADDIN EN.CITE
<EndNote><Author>Lee</Author><Year>1996</Year><RecNum>307</RecNum>
<DisplayText>(Lee et al.
1996)</DisplayText><record><rec-number>307</rec-number><foreign-keys><ke
y app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">307</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Lee,
Younglim</author><author>Lopez, Dolores E.</author><author>Meloni,
Edward G.</author><author>Davis,
Michael</author></authors></contributors><titles><title>A Primary
Acoustic Startle Pathway: Obligatory Role of Cochlear Root Neurons and
the Nucleus Reticularis Pontis Caudalis</title><secondary-title>J.
Neurosci.</secondary-title></titles><periodical><full-title>J.
Neurosci.</full-title></periodical><pages>3775-3789</pages><volume>16</v
olume><number>11</number><dates><year>1996</year><pub-dates><date>June
1,
1996</date></pub-dates></dates><urls><related-urls><url>http://www.jneur
osci.org/cgi/content/abstract/16/11/3775</url></related-urls></urls></re
cord></EndNote> (Lee et al. 1996) .  With regard to pyrethroids,
auditory startle data in adult rats have demonstrated differing response
patterns related to pyrethroid structure   ADDIN EN.CITE   ADDIN
EN.CITE.DATA   (Crofton and Reiter 1984; Tilson et al. 1985; Crofton and
Reiter 1988; Hijzen et al. 1988; Hijzen and Slangen 1988) ; Type I
pyrethroids produced an increase in startle amplitude and Type II
pyrethroids produced a decrease in startle amplitude.  In addition, ASR
has been used to demonstrate age-dependent toxicity in rats following
high oral doses of pyrethroids   ADDIN EN.CITE
<EndNote><Author>Sheets</Author><Year>2000</Year><RecNum>343</RecN
um><DisplayText>(Sheets et al. 1994; Sheets
2000)</DisplayText><record><rec-number>343</rec-number><foreign-keys><ke
y app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">343</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>LP
Sheets</author></authors></contributors><titles><title>A consideration
of age-dependent differences in susceptability to organophosphorus and
pyrethroid
insecticides</title><secondary-title>Neurotoxicology</secondary-title></
titles><periodical><full-title>NeuroToxicology</full-title></periodical>
<pages>57-63</pages><volume>21</volume><dates><year>2000</year></dates><
urls></urls></record><Author>Sheets</Author><Year>1994</Yea
r><RecNum>133</RecNum><record><rec-number>133</rec-number><foreign-keys>
<key app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">133</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Sheets, L.
P.</author><author>Doherty, J. D.</author><author>Law, M.
W.</author><author>Reiter, L. W.</author><author>Crofton, K.
M.</author></authors></contributors><titles><title>Age-Dependent
Differences in the Susceptibility of Rats to
Deltamethrin</title><secondary-title>Toxicology and Applied
Pharmacology</secondary-title></titles><pages>186-190</pages><volume>126
</volume><number>1</number><dates><year>1994</year></dates><isbn>0041-00
8X</isbn><urls><related-urls><url>http://www.sciencedirect.com/science/a
rticle/B6WXH-45PVPD7-1M/2/3fc364aacc860e51234f16417c460620</url></relate
d-urls></urls></record></EndNote> (Sheets et al. 1994; Sheets
2000) .  Therefore, ASR is a potentially sensitive measure to evaluate
differences in neurobehavioral effects between adults and pups.

Since ASR is a behavioral measurement, it is important to consider
development, dose-response and variability during interpretation of the
results.  In rats, the onset of ASR response corresponds to the
development of the external auditory meatus.  In the rat, this usually
occurs between 13 and 16 days of age.  Sheets et al.   ADDIN EN.CITE
<EndNote><Year>1988</Year><RecNum>556</RecNum><DisplayText>(1988)
</DisplayText><record><rec-number>556</rec-number><foreign-keys><key
app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">556</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>LP
Sheets</author><author>KF Dean</author><author>LW
Reiter</author></authors></contributors><titles><title>Ontogeny of the
acoustic startle response and sensitization to background noise in the
rat</title><secondary-title>Behavioral
Neuroscience</secondary-title></titles><periodical><full-title>Behaviora
l
Neuroscience</full-title></periodical><pages>706-13</pages><volume>102</
volume><number>5</number><dates><year>1988</year></dates><urls></urls></
record></EndNote> (1988)  have shown the ability of rats to
respond to ASR as early as PND 13, however, the amplitude of response
continued to increase through PND 21.  Pyrethroids modify the voltage
gated sodium channels in the central nervous system and therefore the
brain is considered the major target organ for toxicity.  Kim et al.
ADDIN EN.CITE <EndNote><Year>2010</Year><RecNum>548</RecNum><DisplayText>(2010)
</DisplayText><record><rec-number>548</rec-number><foreign-keys><key
app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">548</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Kim, K.
B.</author><author>Anand, S. S.</author><author>Kim, H.
J.</author><author>White, C. A.</author><author>Fisher, J.
W.</author><author>Tornero-Velez, R.</author><author>Bruckner, J.
V.</author></authors></contributors><auth-address>Department of
Pharmaceutical Engineering, Inje University, Gimhae, Gyongam 621-749,
Korea.</auth-address><titles><title>Age, dose, and time-dependency of
plasma and tissue distribution of deltamethrin in immature
rats</title><secondary-title>Toxicol
Sci</secondary-title></titles><periodical><full-title>Toxicol
Sci</full-title></periodical><pages>354-68</pages><volume>115</volume><n
umber>2</number><edition>2010/03/10</edition><dates><year>2010</year><pu
b-dates><date>Jun</date></pub-dates></dates><isbn>1096-0929
(Electronic)
1094-2025
(Linking)</isbn><accession-num>20211939</accession-num><urls><related-ur
ls><url>http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d
b=PubMed&dopt=Citation&list_uids=20211939</url></related-urls></
urls><electronic-resource-num>kfq074
[pii]
10.1093/toxsci/kfq074</electronic-resource-num><language>eng</
language></record></EndNote> (2010)  determined the distribution
of deltamethrin, a Type II pyrethroid, in brain, fat, liver, plasma, and
muscle in PND 10, 21, 40, and 90 rats for up to 510 hours.  Brain
concentrations in PND 10 pups were elevated for a longer time relative
to the adults.  This suggests that pyrethroid kinetics in the brain of
pups may not mirror those of adult rats.  The Kim et al.   ADDIN EN.CITE
<EndNote><Year>2010</Year><RecNum>548</RecNum><DisplayText>(2010)
</DisplayText><record><rec-number>548</rec-number><foreign-keys><key
app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">548</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Kim, K.
B.</author><author>Anand, S. S.</author><author>Kim, H.
J.</author><author>White, C. A.</author><author>Fisher, J.
W.</author><author>Tornero-Velez, R.</author><author>Bruckner, J.
V.</author></authors></contributors><auth-address>Department of
Pharmaceutical Engineering, Inje University, Gimhae, Gyongam 621-749,
Korea.</auth-address><titles><title>Age, dose, and time-dependency of
plasma and tissue distribution of deltamethrin in immature
rats</title><secondary-title>Toxicol
Sci</secondary-title></titles><periodical><full-title>Toxicol
Sci</full-title></periodical><pages>354-68</pages><volume>115</volume><n
umber>2</number><edition>2010/03/10</edition><dates><year>2010</year><pu
b-dates><date>Jun</date></pub-dates></dates><isbn>1096-0929
(Electronic)
1094-2025
(Linking)</isbn><accession-num>20211939</accession-num><urls><related-ur
ls><url>http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d
b=PubMed&dopt=Citation&list_uids=20211939</url></related-urls></
urls><electronic-resource-num>kfq074
[pii]
10.1093/toxsci/kfq074</electronic-resource-num><language>eng</
language></record></EndNote> (2010)  study emphasizes the
importance of determining the appropriate time course of effects (i.e.,
time-to-peak-effect and/or time-to-tissue-recovery) in both adult and
non-adult lifestages prior to measuring ASR responses.  Additionally,
the standard deviation for peak amplitude, the ASR measure proposed by
the PPTWG, can vary greatly in guideline DNT studies (20-125%) and
literature reviews   ADDIN EN.CITE
<EndNote><Author>Raffaele</Author><Year>2004</Year><RecNum>545</Re
cNum><DisplayText>(Raffaele et al.
2004)</DisplayText><record><rec-number>545</rec-number><foreign-keys><ke
y app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">545</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Raffaele, Kathleen
C.</author><author>Fisher Jr, J. Edward</author><author>Hancock,
Scott</author><author>Hazelden, Keith</author><author>Sobrian, Sonya
K.</author></authors></contributors><titles><title>Determining normal
variability in a developmental neurotoxicity test A report from the ILSI
Research Foundation/Risk Science Institute expert working group on
neurodevelopmental endpoints</title><secondary-title>Neurotoxicology and
Teratology</secondary-title></titles><periodical><full-title>Neurotoxico
logy and
Teratology</full-title></periodical><pages>288-325</pages><volume>30</vo
lume><number>4</number><keywords><keyword>Developmental neurotoxicity
testing</keyword><keyword>DNT</keyword><keyword>Variability in DNT
testing</keyword><keyword>Regulatory
testing</keyword></keywords><dates><year>2004</year><pub-dates><date>200
8/8//</date></pub-dates></dates><isbn>0892-0362</isbn><urls><related-url
s><url>http://www.sciencedirect.com/science/article/B6T9X-4RHWP06-1/2/81
993766065e550b9b791ec103e19127</url></related-urls></urls></record></Cit
e></EndNote> (Raffaele et al. 2004) .  However, this variability can be
reduced down to 20-30% if the studies are conducted in proven
laboratories   ADDIN EN.CITE
<EndNote><Author>Sette</Author><Year>2004</Year><RecNum>543</RecNu
m><DisplayText>(Sette et al.
2004)</DisplayText><record><rec-number>543</rec-number><foreign-keys><ke
y app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">543</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>W.F.
Sette</author><author>K.M. Crofton</author><author>S.L.
Makris</author><author>J.D. Doherty</author><author>K.C.
Raffaele</author></authors></contributors><titles><title>Auditory
startle reflex habituation in developmental neurotxicity testing; a
cross-laboroatory comparison of control data</title><secondary-title>The
Toxicologist</secondary-title></titles><periodical><full-title>The
Toxicologist</full-title></periodical><pages>275</pages><volume>78</volu
me><dates><year>2004</year></dates><urls></urls></record></EndNot
e> (Sette et al. 2004) .

The PPTWG is proposing that the ASR provides a robust and sensitive
measure of neurotoxicity and is well suited to assess age-dependent
sensitivity to pyrethroids.  Please comment on the appropriateness of
the ASR technique as a measure of pyrethroid induced toxicity, including
suggestions to assure quality of the study design (i.e., appropriate
time-to-peak response, variability of peak response, etc.) and resulting
data.

Age-dependent toxicity has been observed in rat studies following high
doses (i.e., LD50 studies resulting in 50% mortality of test subjects)
of Type II pyrethroids   ADDIN EN.CITE   ADDIN EN.CITE.DATA
(Cantalamessa 1993; Sheets et al. 1994; Sheets 2000) .  However, in
sublethal studies using the ASR as a measure of toxicity, ED50 (dose at
which 50% of the test subjects are affected) values were similar between
postnatal day (PND) 21 and adult rats.  These findings suggest that
age-dependent toxicity may only be observed at high doses.  Based on in
vivo   ADDIN EN.CITE
<EndNote><Author>Cantalamessa</Author><Year>1993</Year><RecNum>342
</RecNum><DisplayText>(Cantalamessa
1993)</DisplayText><record><rec-number>342</rec-number><foreign-keys><ke
y app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">342</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>F
Cantalamessa</author></authors></contributors><titles><title>Acute
toxicity of two pyrethroids, permethrin and cypermethrin, in neonatal
and adult rats</title><secondary-title>Archives of
Toxicology</secondary-title></titles><pages>510-3</pages><volume>67</vol
ume><dates><year>1993</year></dates><urls></urls></record></EndNo
te> (Cantalamessa 1993)  and in vitro   ADDIN EN.CITE
<EndNote><Author>Anand</Author><Year>2006</Year><RecNum>147</RecNu
m><DisplayText>(Anand et al.
2006)</DisplayText><record><rec-number>147</rec-number><foreign-keys><ke
y app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">147</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Anand, Sathanandam
S.</author><author>Bruckner, James V.</author><author>Haines, Wendy
T.</author><author>Muralidhara, Srinivasa</author><author>Fisher,
Jeffrey W.</author><author>Padilla,
Stephanie</author></authors></contributors><titles><title>Characterizati
on of deltamethrin metabolism by rat plasma and liver
microsomes</title><secondary-title>Toxicology and Applied
Pharmacology</secondary-title></titles><pages>156-166</pages><volume>212
</volume><number>2</number><keywords><keyword>Carboxylesterases</keyword
><keyword>CYP450s</keyword><keyword>Deltamethrin</keyword><keyword>Pyret
hroid metabolism</keyword><keyword>Liver
microsomes</keyword><keyword>Plasma</keyword><keyword>Vmax and
Km</keyword><keyword>Rat</keyword></keywords><dates><year>2006</year></d
ates><isbn>0041-008X</isbn><urls><related-urls><url>http://www.sciencedi
rect.com/science/article/B6WXH-4H45GTM-1/2/ef2038f2560398715f630d868e5a8
9f5</url></related-urls></urls></record></EndNote> (Anand et al.
2006)  studies, the apparent discrepancy between high- and low-dose
age-dependent toxicity is likely attributable to incomplete maturation
of the enzymes that detoxify pyrethroids in immature animals,
particularly the carboxylesterases and cytochrome P450s.  These
clearance mechanisms are overwhelmed in younger animals given LD50
doses, leading to increased accumulation of the pyrethroids in nervous
tissue and ultimately increased toxicity.

Carboxylesterases and P450 enzymes are the two major enzyme families
responsible for metabolism of pyrethroids.  In the rat, it has been
shown that carboxylesterase activities are below adult levels at weaning
  ADDIN EN.CITE   ADDIN EN.CITE.DATA   (Moser et al. 1998; Karanth and
Pope 2000; Anand et al. 2006; de Zwart et al. 2008; Yang et al. 2009) .
Information on the ontogeny of carboxylesterase development in the human
is more limited.  However, increased plasma esterase activity during
postnatal maturation has been reported   ADDIN EN.CITE
<EndNote><Author>Ecobichon</Author><Year>1973</Year><RecNum>557</R
ecNum><DisplayText>(Ecobichon and Stephens
1973)</DisplayText><record><rec-number>557</rec-number><foreign-keys><ke
y app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">557</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>DJ
Ecobichon</author><author>DS
Stephens</author></authors></contributors><titles><title>Perinatal
development of human blood esterases</title><secondary-title>Clinical
Pharmacology and
Therapeutics</secondary-title></titles><periodical><full-title>Clinical
Pharmacology and
Therapeutics</full-title></periodical><pages>41-7</pages><volume>14</vol
ume><number>1</number><dates><year>1973</year></dates><urls></urls></rec
ord></EndNote> (Ecobichon and Stephens 1973) .  In contrast, Pope
et al.   ADDIN EN.CITE <EndNote><Year>2005</Year><RecNum>404</RecNum><DisplayText>(2005)
</DisplayText><record><rec-number>404</rec-number><foreign-keys><key
app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">404</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Pope, Carey
N.</author><author>Karanth, Subramanya</author><author>Liu,
Jing</author><author>Yan,
Bingfang</author></authors></contributors><titles><title>Comparative
carboxylesterase activities in infant and adult liver and their in vitro
sensitivity to chlorpyrifos oxon</title><secondary-title>Regulatory
Toxicology and
Pharmacology</secondary-title></titles><pages>64-69</pages><volume>42</v
olume><number>1</number><keywords><keyword>Age-related
sensitivity</keyword><keyword>Risk
assessment</keyword><keyword>Organophosphates</keyword><keyword>Detoxifi
cation</keyword></keywords><dates><year>2005</year></dates><isbn>0273-23
00</isbn><urls><related-urls><url>http://www.sciencedirect.com/science/a
rticle/B6WPT-4FJTP9Y-3/2/a80156cc0bd89f6c5c5ea3679101e704</url></related
-urls></urls></record></EndNote> (2005)  found carboxylesterase
activity in hepatic tissues were similar for humans ranging in age from
2 months to 36 years, however, the sample sizes were small and
variability among the age groups was high.  Maturation of the P450
enzymes shows a similar trend.  2C19, a P450 enzyme which has shown high
pyrethroid metabolic activity   ADDIN EN.CITE
<EndNote><Author>Godin</Author><Year>2006</Year><RecNum>402</RecNu
m><DisplayText>(Godin et al.
2006)</DisplayText><record><rec-number>402</rec-number><foreign-keys><ke
y app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">402</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Godin, Stephen
J.</author><author>Scollon, Edward J.</author><author>Hughes, Michael
F.</author><author>Potter, Philip M.</author><author>DeVito, Michael
J.</author><author>Ross, Matthew
K.</author></authors></contributors><titles><title>Species Differences
in the in Vitro Metabolism of Deltamethrin and Esfenvalerate:
Differential Oxidative and Hydrolytic Metabolism by Humans and
Rats</title><secondary-title>Drug Metab
Dispos</secondary-title></titles><pages>1764-1771</pages><volume>34</vol
ume><number>10</number><dates><year>2006</year><pub-dates><date>October
1,
2006</date></pub-dates></dates><urls><related-urls><url>http://dmd.aspet
journals.org/cgi/content/abstract/34/10/1764</url></related-urls></urls>
<electronic-resource-num>10.1124/dmd.106.010058</electronic-resource-num
></record></EndNote> (Godin et al. 2006) , increases rapidly in
the human during first 2 years of life, whereas numerous P450s examined
in the rat have minimal expression levels through gestation and do not
approach adult levels of expression until PND10 days or later   ADDIN
EN.CITE <EndNote><Author>de
Zwart</Author><Year>2008</Year><RecNum>403</RecNum><DisplayText>(de
Zwart et al.
2008)</DisplayText><record><rec-number>403</rec-number><foreign-keys><ke
y app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">403</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>de Zwart,
Loeckie</author><author>Scholten, Martijn</author><author>Monbaliu,
Johan G.</author><author>Annaert, Pieter P.</author><author>Van Houdt,
Jos M.</author><author>Van den Wyngaert, Ilse</author><author>De
Schaepdrijver, Luc M.</author><author>Bailey, Graham
P.</author><author>Coogan, Timothy P.</author><author>Coussement, Werner
C.</author><author>Mannens, Geert
S.</author></authors></contributors><titles><title>The ontogeny of drug
metabolizing enzymes and transporters in the
rat</title><secondary-title>Reproductive
Toxicology</secondary-title></titles><pages>220-230</pages><volume>26</v
olume><number>3-4</number><keywords><keyword>Juvenile
animals</keyword><keyword>Ontogeny</keyword><keyword>Metabolizing
enzymes</keyword><keyword>Transporters</keyword></keywords><dates><year>
2008</year><pub-dates><date>2008/12//</date></pub-dates></dates><isbn>08
90-6238</isbn><urls><related-urls><url>http://www.sciencedirect.com/scie
nce/article/B6TC0-4TMBPSC-3/2/9d9dc93a5df5eb40242776111c859516</url></re
lated-urls></urls></record></EndNote> (de Zwart et al. 2008) .

Comparisons between lifestages in the rat and human are difficult
because of the ontogeny of the brain development and metabolizing
enzymes are not an exact match.  However, PND 11 rats are considered to
be close in development to newborn humans and PND 17 rats are believed
to be closer developmentally to human toddlers   ADDIN EN.CITE   ADDIN
EN.CITE.DATA   (Davision and Dobbing 1966; Dobbing and Smart 1974;
Benjamins and McKhann 1981) .  From the aspect of exposure, previous
experience with developing cumulative risk assessments for other
insecticide groups, ongoing work on HED's Standard Operating Procedures
for Residential Pesticide Exposure Assessment, and the Agency's Guidance
on Selecting Age Groups for Monitoring and Assessing Childhood Exposures
for Environmental Contaminants  HYPERLINK
"http://www.epa.gov/raf/publications/guidance-on-selecting-age-groups.ht
m"
http://www.epa.gov/raf/publications/guidance-on-selecting-age-groups.htm
, the Agency believes that children three years old and younger,
particularly those who are mobile (crawling, walking) and who exhibit
hand-to-mouth behavior, have the potential for the greatest exposure to
pyrethroids.  Based on 1) the current understanding that the two major
enzyme families responsible for the metabolism of pyrethroids are below
adult activity levels at weaning (i.e., PND 21); 2) PND 17 rats are
approximately comparable to human toddlers in terms of development; and
3) children younger than 3 years of age are expected to have the
greatest exposures to pyrethroids, the Agency is concerned with the
PPTWG’s proposal to conduct ASR studies in PND 21 rats.  Instead, PND
15 to 17 rats, which have been shown to respond to ASR stimuli   ADDIN
EN.CITE
<EndNote><Author>Sheets</Author><Year>1988</Year><RecNum>556</RecN
um><DisplayText>(Sheets et al.
1988)</DisplayText><record><rec-number>556</rec-number><foreign-keys><ke
y app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">556</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>LP
Sheets</author><author>KF Dean</author><author>LW
Reiter</author></authors></contributors><titles><title>Ontogeny of the
acoustic startle response and sensitization to background noise in the
rat</title><secondary-title>Behavioral
Neuroscience</secondary-title></titles><periodical><full-title>Behaviora
l
Neuroscience</full-title></periodical><pages>706-13</pages><volume>102</
volume><number>5</number><dates><year>1988</year></dates><urls></urls></
record></EndNote> (Sheets et al. 1988) , may better represent the
most susceptible human lifestage.

The PPTWG has proposed to use conduct ASR studies on 21-day old rats.
Please comment on the appropriateness of this age group in regards to i)
assessing age-dependent toxicity and ii) assessing whether the 21-day
old rat will adequately inform the Agency regarding toxicity as it
relates to children three years of age and younger.

12:00  P.M.	LUNCH

1:00 P.M. 	Charge Question 1 cont’d

2:00 P.M.	Charge Question 2

Physiologically-Based Pharmacokinetic (PBPK) Modeling

The PPTWG is proposing to use a model developed collaboratively by
EPA’s Office of Research and Development (ORD) and the University of
Georgia as a starting point in their modeling effort.  EPA’s ORD has
published a series of papers that describe the development and
enhancement of pyrethroid PBPK models starting with a deltamethrin model
in rats by Mirfazaelian et al.   ADDIN EN.CITE <EndNote><Year>2006</Year><RecNum>477</RecNum><DisplayText>(2006)
</DisplayText><record><rec-number>477</rec-number><foreign-keys><key
app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">477</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Mirfazaelian,
A</author><author>Kim, KB</author><author>Anand, SS</author><author>Kim,
HJ</author><author>Tornero-Velez, R</author><author>Bruckner,
JV</author><author>Fisher,
JW</author></authors></contributors><titles><title>Development of a
physiologically based pharmacokinetic model for deltamethrin in the
adult male Sprague-Dawley rat</title><secondary-title>Toxicol
Sci</secondary-title></titles><periodical><full-title>Toxicol
Sci</full-title></periodical><pages>432 -
442</pages><volume>93</volume><number>2</number><dates><year>2006</year>
</dates><urls></urls></record></EndNote> (2006)  , improved by
Godin et al.  ADDIN EN.CITE <EndNote><Year>2010</Year><RecNum>542</RecNum><DisplayText>(2010)
</DisplayText><record><rec-number>542</rec-number><foreign-keys><key
app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">542</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Godin, Stephen
J.</author><author>DeVito, Michael J.</author><author>Hughes, Michael
F.</author><author>Ross, David G.</author><author>Scollon, Edward
J.</author><author>Starr, James M.</author><author>Setzer, R.
Woodrow</author><author>Conolly, Rory B.</author><author>Tornero-Velez,
Rogelio</author></authors></contributors><titles><title>Physiologically
Based Pharmacokinetic Modeling of Deltamethrin: Development of a Rat and
Human Diffusion-Limited Model</title><secondary-title>Toxicol.
Sci.</secondary-title></titles><periodical><full-title>Toxicol.
Sci.</full-title></periodical><pages>330-343</pages><volume>115</volume>
<number>2</number><dates><year>2010</year><pub-dates><date>June 1,
2010</date></pub-dates></dates><urls><related-urls><url>http://toxsci.ox
fordjournals.org/cgi/content/abstract/115/2/330</url></related-urls></ur
ls><electronic-resource-num>10.1093/toxsci/kfq051</electronic-resource-n
um></record></EndNote> (2010) , modified for permethrin by
Tornero-Velez et al. (in prep.), and finally expanded to include age-
and chemical-dependent parameters by Tornero-Velez et al.   ADDIN
EN.CITE <EndNote><Year>2010</Year><RecNum>541</RecNum><DisplayText>(2010)
</DisplayText><record><rec-number>541</rec-number><foreign-keys><key
app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">541</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Rogelio
Tornero-Velez</author><author>Ahmad
Mirfazaelian</author><author>Kyu-Bong Kim</author><author>Sathanandam S.
Anand</author><author>Hyo J. Kim</author><author>Wendy T.
Haines</author><author>James V, Bruckner</author><author>Jeffrey W.
Fisher</author></authors></contributors><titles><title>Evaluation of
deltamethrin kinetics and dosimetry in the maturing rat using a PBPK
model</title><secondary-title>Toxicol Appl
Pharmacol</secondary-title></titles><periodical><full-title>Toxicol Appl
Pharmacol</full-title></periodical><pages>208-17</pages><volume>244</vol
ume><dates><year>2010</year></dates><urls></urls></record></EndNo
te> (2010) .  In 2007, ORD and OPP jointly presented an issue paper to
the SAP   ADDIN EN.CITE
<EndNote><Author>USEPA</Author><Year>2007</Year><RecNum>561</RecNu
m><DisplayText>(USEPA
2007)</DisplayText><record><rec-number>561</rec-number><foreign-keys><ke
y app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">561</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>USEPA</author></aut
hors></contributors><titles><title>Assessing Approaches for the
Development of PBPK Models of Pyrethroid Pesticides.
www.epa.gov/scipoly/sap/meetings/2007/august/pyrethroidpbpk_sap_2007_fin
alv1.pdf</title></titles><dates><year>2007</year></dates><urls></urls></
record></EndNote> (USEPA 2007)  which described an approach for
using a generic model structure with chemical specific parameters for
pyrethroids.  The “family modeling” approach was endorsed by the SAP
and has been successfully applied in the above PBPK efforts.  The Agency
believes that it is both reasonable and scientifically sound to use the
Tornero-Velez et al.   ADDIN EN.CITE <EndNote><Year>2010</Year><RecNum>541</RecNum><DisplayText>(2010)
</DisplayText><record><rec-number>541</rec-number><foreign-keys><key
app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">541</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Rogelio
Tornero-Velez</author><author>Ahmad
Mirfazaelian</author><author>Kyu-Bong Kim</author><author>Sathanandam S.
Anand</author><author>Hyo J. Kim</author><author>Wendy T.
Haines</author><author>James V, Bruckner</author><author>Jeffrey W.
Fisher</author></authors></contributors><titles><title>Evaluation of
deltamethrin kinetics and dosimetry in the maturing rat using a PBPK
model</title><secondary-title>Toxicol Appl
Pharmacol</secondary-title></titles><periodical><full-title>Toxicol Appl
Pharmacol</full-title></periodical><pages>208-17</pages><volume>244</vol
ume><dates><year>2010</year></dates><urls></urls></record></EndNo
te> (2010)  PBPK model as the starting point for the PPTWG effort to
build PBPK models for pyrethroids to assess young children.
Furthermore, the PPTWG is proposing to develop PBPK models using in
vitro and in vivo rat data, and then using human in vitro data to inform
model to predict human internal dosimetry, similar to the approach which
was previously supported by the 2007 SAP.

The PPTWG proposes to increase the complexity of the Tornero-Velez et
al.   ADDIN EN.CITE <EndNote><Year>2010</Year><RecNum>541</RecNum><DisplayText>(2010)
</DisplayText><record><rec-number>541</rec-number><foreign-keys><key
app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">541</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Rogelio
Tornero-Velez</author><author>Ahmad
Mirfazaelian</author><author>Kyu-Bong Kim</author><author>Sathanandam S.
Anand</author><author>Hyo J. Kim</author><author>Wendy T.
Haines</author><author>James V, Bruckner</author><author>Jeffrey W.
Fisher</author></authors></contributors><titles><title>Evaluation of
deltamethrin kinetics and dosimetry in the maturing rat using a PBPK
model</title><secondary-title>Toxicol Appl
Pharmacol</secondary-title></titles><periodical><full-title>Toxicol Appl
Pharmacol</full-title></periodical><pages>208-17</pages><volume>244</vol
ume><dates><year>2010</year></dates><urls></urls></record></EndNo
te> (2010)  PBPK model by modifying some aspects.  For example, the
PPTWG is proposing to:

Predict intestinal permeability through the use of Ussing Chamber
technique with rat cells and human Caco-2 cells, with the potential to
increase the number of compartments within the intestinal tract

In vitro determination of partition coefficients

Obtain estimates of protein binding

Please comment on the proposed modifications to the Tornero-Velez et al.
  ADDIN EN.CITE <EndNote><Year>2010</Year><RecNum>541</RecNum><DisplayText>(2010)
</DisplayText><record><rec-number>541</rec-number><foreign-keys><key
app="EN"
db-id="zdpes0tpafsdwre0ssb5w9si25trr2fsa9wr">541</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Rogelio
Tornero-Velez</author><author>Ahmad
Mirfazaelian</author><author>Kyu-Bong Kim</author><author>Sathanandam S.
Anand</author><author>Hyo J. Kim</author><author>Wendy T.
Haines</author><author>James V, Bruckner</author><author>Jeffrey W.
Fisher</author></authors></contributors><titles><title>Evaluation of
deltamethrin kinetics and dosimetry in the maturing rat using a PBPK
model</title><secondary-title>Toxicol Appl
Pharmacol</secondary-title></titles><periodical><full-title>Toxicol Appl
Pharmacol</full-title></periodical><pages>208-17</pages><volume>244</vol
ume><dates><year>2010</year></dates><urls></urls></record></EndNo
te> (2010)  model as described in sections 4.3 of the PPTWG proposal.
Please include in

your comments consideration for balancing potentially improved
performance resulting from the increased complexity with model
parsimony.

2.2   	Microsomal incubation studies have been used to inform the
pyrethroid PBPK models developed by ORD (Mirfazaelian et al. 2006;
Scollon et al. 2009; Godin et al. 2010; Tornero-Velez et al. 2010;
Tornero-Velez in prep.). The PPTWG has proposed to use intact
hepatocytes instead because they may provide a better prediction of
metabolism compared to microcellular fractions (Hewitt et al. 2007).
Additionally, the PPTWG is proposing to compare the clearance activity
of human hepatocytes and microsomal fractions for several age groups.
However, the Agency notes that there are a limited number of human
hepatocyte samples available to inform the PBPK model. Pooled human
microsomes are available representing larger segments of the population
relative to hepatocyte availability. The Working Group suggests
characterization of the hepatocytes (i.e., cypP450 and esterase
composition) and establishing a relationship between hepatocytes and
microsomal fraction activities may reduce model uncertainty in light of
limited data.

Please comment on the strengths and weaknesses of the PPTWG proposal to
use hepatocytes in the PBPK effort, including the potential for
hepatocytes to decrease uncertainty of model predictions in light of
limited data.

3:15 P.M.	BREAK

3:30 P.M.	Charge Question 3

Alternative Study Design(s) For Evaluating Age Differences in
Pharmacokinetics

The Agency gives special consideration to the potential pre- and
postnatal lifestages regarding potential exposure to pesticides.
Pre-natal exposure to pyrethroids has been evaluated extensively in over
80 developmental toxicity, reproductive toxicity, and DNT test guideline
studies and no sensitivity from in utero exposure has been observed.  As
previously described, there are gaps in knowledge surrounding the
potential for post-natal sensitivity and, as described in Question 1.2,
the Agency considers children less than 3 years of age to be the most
susceptible population.  The PPTWG has proposed a robust PBPK model
development effort to describe pyrethroid dosimetry across several
lifestages; however, these models will not be ready for use by the
Agency until approximately 2013.

Are there alternative approaches using empirical or data generation
techniques potentially requiring less time than the PBPK effort proposed
by the PPTWG for evaluating the potential for post-natal sensitivity,
particularly with respect to differences in pharmacokinetic profiles,
that could be used by the Agency?

5:00 P.M.	Adjourn

Please be advised that agenda times are approximate; when the discussion
for one topic is completed, discussions for the next topic will begin.
For further information, please contact the Designated Federal Official
for this meeting, Dr. Sharlene Matten, via telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; or email:   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>.

 PAGE

 PAGE   2


[Federal Register Volume 77, Number 174 (Friday, September 7, 2012)]
[Notices]
[Pages 55202-55203]
[FR Doc No: 2012-22052]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13005-003]

Oliver Hydro LLC; Notice of Application Accepted for Filing and
Soliciting Motions To Intervene and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Original Major License.
    b. Project No.: 13005-003.
    c. Date filed: December 14, 2011.
    d. Applicant: Oliver Hydro LLC.
    e. Name of Project: William Bacon Oliver Lock and Dam Hydroelectric
Project.
    f. Location: At the U.S. Army Corps of Engineers' (Corps) William
Bacon Oliver Lock and Dam on the Black Warrior River, in Tuscaloosa
County, Alabama. The project would occupy 8.7 acres of United States
lands administered by the Corps' Mobile District.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)--825(r).
    h. Applicant Contact: Brent Smith, Symbiotics LLC, 371 Upper
Terrace, Suite 2, Bend, OR 97702;<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    i. FERC Contact: Allan Creamer at<PHONE_NUMBER>, or via email at
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted, but is not ready for
environmental analysis at this time.
    l. The proposed project would utilize the Corps' existing William
Bacon Oliver Lock and Dam, and would consist of the following new
facilities: (1) A forebay; (2) an intake structure; (3) a powerhouse
containing two generating units with a total capacity of 11.72
megawatts (MW); (4) a 150-foot-long, 68-foot-wide tailrace; (5) a
proposed 1.7-mile-long, 25 kilovolt (kV) transmission line; (6) a
switchyard; and (7) appurtenant facilities. The proposed project would
have an average annual generation of 42.6 GWh, and operate in a run-of-
river mode utilizing surplus water from the William Bacon Oliver Lock
and Dam, as directed by the Corps.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov, using the ``eLibrary''
link. Enter the docket number, excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Anyone may submit a protest or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, 385.211, and 385.214. In determining the appropriate
action to take, the Commission will consider all protests filed, but
only those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any protests
or motions to intervene must be received on, or before, the specified
deadline date for the particular application.
    All filings must: (1) Bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE;'' (2) set forth in the heading
the name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to

intervene must be served upon each representative of the applicant
specified in the particular application.
    o. Procedural schedule and final amendments: The application will
be processed according to the following Hydro Licensing Schedule.
Revisions to the schedule will be made as appropriate.

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

------------------------------------------------------------------------
Issue Scoping Document 1...............  August 2012.
Issue Scoping Document 2 (if necessary)  October 2012.
Notice of application is ready for       February 2013.
 environmental analysis.
Notice of availability of the EA.......  October 2013.
------------------------------------------------------------------------

    Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.
    n. Any qualified applicant desiring to file a competing application
must submit to the Commission, on or before the specified intervention
deadline date, a competing development application, or a notice of
intent to file such an application. Submission of a timely notice of
intent allows an interested person to file the competing development
application no later than 120 days after the specified intervention
deadline date. Applications for preliminary permits will not be
accepted in response to this notice.
    A notice of intent must specify the exact name, business address,
and telephone number of the prospective applicant, and must include an
unequivocal statement of intent to submit a development application. A
notice of intent must be served on the applicant(s) named in this
public notice.

    Dated: August 31, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-22052 Filed 9-6-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Notices]
[Pages 29634-29635]
[FR Doc No: 2012-12072]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of FERC Staff Attendance at the Louisiana Public Service
Commission's Business and Executive Session Meeting

    The Federal Energy Regulatory Commission hereby gives notice that
members of its staff may attend the meeting noted below. Their
attendance is part of the Commission's ongoing outreach efforts.

Louisiana Public Service Commission's Business and Executive Session
Meeting

    May 23, 2012 9:30 a.m.
    This meeting will be held at the Lafayette Consolidated Government
Building Council Auditorium, 705 West University Ave., Lafayette, LA
70506.
    The discussions may address matters at issue in the following
proceedings:

Docket No. OA07-32                          Entergy Services, Inc.
Docket No. EL00-66                          Louisiana Public Service
                                             Commission v. Entergy
                                             Services, Inc.
Docket No. EL01-88                          Louisiana Public Service
                                             Commission v. Entergy
                                             Services, Inc.
Docket No. EL08-51                          Louisiana Public Service
                                             Commission v. Entergy
                                             Services, Inc.
Docket No. EL08-60                          Ameren Services Co. v.
                                             Entergy Services, Inc.
Docket No. EL09-43                          Arkansas Public Service
                                             Commission v. Entergy
                                             Services, Inc.
Docket No. EL09-50                          Louisiana Public Service
                                             Commission v. Entergy
                                             Services, Inc.
Docket No. EL09-61                          Louisiana Public Service
                                             Commission v. Entergy
                                             Services, Inc.
Docket No. EL10-65                          Louisiana Public Service
                                             Commission v. Entergy
                                             Services, Inc.

Docket No. EL11-34                          Midwest Independent System
                                             Transmission Operator, Inc.
Docket No. EL11-63                          Louisiana Public Service
                                             Commission v. Entergy
                                             Services, Inc.
Docket No. ER05-1065                        Entergy Services, Inc.
Docket No. ER07-682                         Entergy Services, Inc.
Docket No. ER09-833                         Entergy Services, Inc.
Docket No. ER10-794                         Entergy Services, Inc.
Docket No. ER10-1350                        Entergy Services, Inc.
Docket No. ER10-1676                        Entergy Services, Inc.
Docket No. ER10-2001                        Entergy Arkansas, Inc.
Docket No. ER10-3357                        Entergy Arkansas, Inc.
Docket No. ER11-3156                        Entergy Arkansas, Inc.
Docket No. ER11-3657                        Entergy Arkansas, Inc.
Docket No. ER12-480                         Midwest Independent
                                             Transmission System
                                             Operator, Inc.
Docket No. ER12-1384                        Entergy Services, Inc.
Docket No. ER12-1385                        Entergy Services, Inc.
Docket No. ER12-1386                        Entergy Services, Inc.
Docket No. ER12-1387                        Entergy Services, Inc.
Docket No. ER12-1388                        Entergy Services, Inc.
Docket No. ER12-1390                        Entergy Services, Inc.

    The meeting is open to the public.
    For more information, contact Patrick Clarey, Office of Energy
Market Regulation, Federal Energy Regulatory Commission at (317) 249-
5937 or<EMAIL_ADDRESS>
    Dated: May 14, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-12072 Filed 5-17-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Proposed Rules]
[Page 3466-3468]
[DOCID:fr21ja09-27]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-1167; Airspace Docket No. 08-ASO-16]

Proposed Amendment of the South Florida Low Offshore Airspace
Area; Florida

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend the altitude floor of the South
Florida Low Offshore Airspace Area, located off the east coast of the
United States (U.S.). This action would lower the floor of the area
from 2,700 feet above mean sea level (MSL) to 1,300 feet MSL. The
change would provide additional altitudes for air traffic control to
vector aircraft on arrival to various east coast airports, ensuring the
safety of aircraft and the efficient use of airspace within the
National Airspace System.

DATES: Comments must be received on or before March 9, 2009.

ADDRESSES: Send comments on the proposal to the U.S. Department of
Transportation, Docket Operations, M-30, 1200 New Jersey Avenue, SE.,
West Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
telephone:<PHONE_NUMBER>. You must identify the docket number FAA-
2008-1167 and Airspace Docket No. 08-ASO-16 at the beginning of your
comments. You may also submit comments on the Internet at http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace and Rules
Group, Office of System Operations Airspace and AIM, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2008-1167 and Airspace Docket No. 08-ASO-16) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenter's wishing the FAA to acknowledge receipt of their
comments on this action must submit with those comments a self-
addressed, stamped postcard on which the following statement is made:
``Comments to FAA

Docket No. FAA-2008-1167 and Airspace Docket No. 08-ASO-16.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://
www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_
amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. An
informal docket may also be examined during normal business hours at
the office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia
30337.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to modify the designated altitude floor of
the South Florida Low Offshore Airspace area. The proposed change would
lower the floor of the area from 2,700 feet MSL to 1,300 feet MSL.
Currently, Air Traffic Control (ATC) cannot vector arriving aircraft
below 2,700 feet MSL while operating within the South Low Offshore
Airspace Area. The proposed change would provide additional controlled
airspace so that ATC could use lower altitudes while vectoring aircraft
on arrival to Myrtle Beach, SC; Fort Myers, FL; Fort Lauderdale, FL;
and Miami, FL. The change would increase ATC system efficiency and
reduce complexity at these airports.
    Offshore airspace areas are published in paragraph 6007, of FAA
Order 7400.9S signed October 3, 2008 and effective October 31, 2008,
which is incorporated by reference in 14 CFR 71.1. The offshore
airspace area listed in this document will be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation: (1) Is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under Department of Transportation (DOT)
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies the low offshore airspace area in Florida.

ICAO Considerations

    As part of this proposal relates to navigable airspace outside the
United States, this notice is submitted in accordance with the
International Civil Aviation Organization (ICAO) International
Standards and Recommended Practices.
    The application of International Standards and Recommended
Practices by the FAA, Office of System Operations Airspace and AIM,
Airspace & Rules Group, in areas outside the United States domestic
airspace, is governed by the Convention on International Civil
Aviation. Specifically, the FAA is governed by Article 12 and Annex 11,
which pertain to the establishment of necessary air navigational
facilities and services to promote the safe, orderly, and expeditious
flow of civil air traffic. The purpose of Article 12 and Annex 11 is to
ensure that civil aircraft operations on international air routes are
performed under uniform conditions.
    The International Standards and Recommended Practices in Annex 11
apply to airspace under the jurisdiction of a contracting state,
derived from ICAO. Annex 11 provisions apply when air traffic services
are provided and a contracting state accepts the responsibility of
providing air traffic services over high seas or in airspace of
undetermined sovereignty. A contracting state accepting this
responsibility may apply the International Standards and Recommended
Practices that are consistent with standards and practices utilized in
its domestic jurisdiction.
    In accordance with Article 3 of the Convention, state-owned
aircraft are exempt from the Standards and Recommended Practices of
Annex 11. The United States is a contracting state to the Convention.
Article 3(d) of the Convention provides that participating state
aircraft will be operated in international airspace with due regard for
the safety of civil aircraft. Since this action involves, in part, the
designation of navigable airspace outside the United States, the
Administrator is consulting with the Secretary of State and the
Secretary of Defense in accordance with the provisions of Executive
Order 10854.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9S, Airspace Designations and Reporting

Points, signed October 3, 2008 and effective October 31, 2008, is
amended as follows:

Paragraph 6007 Offshore Airspace Areas.

* * * * *

South Florida Low, FL [Amended]

    That airspace extending upward from 1,300 feet MSL bounded on
the west by the Houston Oceanic CTA/FIR; bounded on the north from
west to east by the Jacksonville Air Route Traffic Control Center
boundary, a line 12 miles from and parallel to the U.S. shoreline
and lat. 34[deg]00'00'' N., bounded on the east by the New York
Oceanic CTA/FIR and the San Juan Oceanic CTA/FIR; bounded on the
south from east to west by the Santo Domingo FIR, the Port-Au-Prince
CTA/FIR and the Havana CTA/FIR; excluding the Grand Bahama TCA and
the Nassau TCA.
* * * * *

    Issued in Washington, DC, on January 12, 2009.
Edith V. Parish,
Manager, Airspace and Rules Group.
 [FR Doc. E9-1111 Filed 1-16-09; 8:45 am]

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