UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

THIS DOCUMENT IN ON THE H:\ DRIVE

MEMORANDUM

DATE:		September 3, 2008

SUBJECT:		Tier I Estimated Drinking Water Concentrations of
Fenpropathrin: IR-4 Tolerance Petition for the Use of Fenpropathrin on
Tree Nuts and Pistachio, Barley, Tropical and Sub Tropical Fruits,
Bushberries, Fruiting Vegetables, Peas, Caneberries and Olives (PC Code
127901, DP Barcodes D313331, D333118,  D342501 and D347897).

FROM:	José Luis Meléndez, Chemist

				Environmental Risk Branch V

				Environmental Fate and Effects Division (7507P)

TO:				Sidney Jackson, Risk Manager

				Daniel Rosenblatt, Branch Chief

				Risk Integration, Minor Use and Emergency Response Branch

				Registration Division (7505P)

				Olga Odiot, Risk Manager Reviewer

				George LaRocca, Risk Manager

				Marion Johnson, Branch Chief

				Insecticide Branch

				Registration Division (7505P)

AND				Christina Swartz, Branch Chief

				Registration Action Branch II

				Health Effects Division (7509P)

THROUGH:	Mah T. Shamim, Ph.D., Chief

Environmental Risk Branch V

				Environmental Fate and Effects Division (7507P)

This memo presents the Tier I Estimated Drinking Water Concentrations
(EDWCs) for fenpropathrin, calculated using FIRST (surface water) and
SCI-GROW (ground water) for use in the human health risk assessment.
The registrant seeks to establish tolerances for use on tree nuts and
pistachio, barley, tropical and sub tropical fruits, bushberries,
fruiting vegetables, peas, caneberries and olives.

The EFED has found that the scenario with the highest rate and minimum
interval between applications is grapes.  This scenario was assessed in
the previous drinking waters assessment (D295472) and the Division is
relying on it to cover the new uses.

For surface water, the acute (peak) value is 10.3 ppb and the chronic
(annual average) value is 1.81 ppb.  The groundwater screening
concentration is 0.00480 ppb.  These values generally represent
upper-bound estimates of the concentrations that might be found in
surface water and groundwater due to the use of fenpropathrin on grapes.
 Both models provide estimates suitable for screening purposes.
Additional refinements can be developed should they be needed by HED.
Should any questions arise, please, contact José Meléndez (EFED).

Data gaps:

The database for fenpropathrin is substantially complete.  The mobility
(batch equilibrium) study was found to be supplemental because
Freundlich KF’s and KFOC’s could only be determined for the loam.
Kd’s and KOC’s could not be determined for the silt loam sediment,
and sandy loam, silt loam, sandy loam and clay loam soils at all
concentrations.  However, at this time, no additional data are required.

EXECUTIVE SUMMARY

)-α-cyano-3-phenoxybenzyl 2,2,3,3-tetramethylcyclopropanecarboxylate]
is a Type II synthetic pyrethroid insecticide and miticide (IRAC’s
classification Group 3 – includes pyrethroids and pyrethrins).
Fenpropathrin has two chiral centers, one in the carbon attached to the
cyano group and one in a carbon of the cyclopropyl moiety (refer to
structure in the appendix).

Fenpropathrin is a neural toxic insecticide acting through direct
contact and ingestion, having a slight repellent effect. The primary
biological effects of fenpropathrin and other pyrethroids on insects and
vertebrates reflect an inhibition of the correct firing of
neurotransmitter deliver signals from one cell to another via nerve
membrane inhibition of the voltage-gated Ca2+ channels (calcium ion
channels) coupled with a stimulatory effect on the voltage-gated Na+
channels (sodium ion channels).  All pyrethroids act as axonic poisons,
affecting both the peripheral and central nervous systems, and share
similar modes of action.  Pyrethroids, including fenpropathrin,
stimulate repetitive action in the nervous system by binding to
voltage-gated sodium channels, prolonging the sodium ion permeability
during the excitatory phase of the action potential.  This action leads
to spontaneous depolarizations, augmented neurotransmitter secretion
rate and neuromuscular block, which ultimately results in paralysis of
the insect.

Fenpropathrin is currently used on a variety of crops, including cotton,
head and stem brassica, bushberries and currant, citrus, cucurbits,
fruiting vegetables, grapes, peanuts, pome fruits, strawberries and
peas.  The registrant seeks to establish tolerances for use on tree nuts
and pistachio, barley, tropical and sub tropical fruits, bushberries,
fruiting vegetables, peas, caneberries crop and olives (Section 3 –
new use or IR-4 requests).  Fenpropathrin may be applied by ground,
airblast or aerial methods.

This is a Tier 1 screening-level drinking water analysis (DWA) as a
result of a Section 3 and IR-4 requests for tolerances.  The Tier 1
models utilized were FIRST and SCI-GROW for surface and ground waters,
respectively.  There are no major degradates for fenpropathrin;
therefore, no degradates were modeled in this assessment.  Only the
parent compound was included in the drinking water expression.  A source
of uncertainty for the results of fenpropathrin is that Kd’s and
KOC’s could not be determined for four of the soils and sediments at
all concentrations.  Table 1 provides a summary of the EDWCs obtained in
the assessment.  The EFED relied on the previous DWA since the scenario
of highest exposure is grapes, which was assessed in the previous DWA.
Please, refer to the appendix, which contains an electronic copy of the
Tier 1 DWA that was performed earlier.  Additional refinements are
available using higher tier aquatic models, should it be needed by HED.

Table 1.  Maximum Tier I Estimated Drinking Water Concentrations (EDWCs)
for drinking water assessment based on aerial application of
Fenpropathrin

DRINKING WATER SOURCE (MODEL USED) 	USE (rate modeled)	MAXIMUM ESTIMATED
DRINKING WATER CONCENTRATION  (EDWC)  ( ppb)

Groundwater (SCI-GROW)	Grapes (0.8 lb a.i./A/season)	Acute and Chronic
0.00480

Surface water  (FIRST)	Grapes (0.8 lb a.i./A/season)	Acute	10.3

Chronic	            1.81

Use Characterization

A summary table of all use patterns, with the new uses shaded, and Tier
I modeled uses in bold font, is illustrated below (Table 2).

  SEQ CHAPTER \h \r 1

Table 2.  Summary use information for fenpropathrin, based on DANITOL®
2.4 EC Spray (Reg. No. 59639-35) current and proposed labels (shaded).
The use pattern selected for modeling is bolded.

USE	SINGLE  APP. RATE             (lbs. a.i./A)	NUMBER OF APPS.	SEASONAL
APP. RATE (lbs. a.i./A)	INTERVAL BETWEEN APPS. (days)	APP. METHOD
PRE-HARVEST INTERVAL (days)

Head and stem brassica (broccoli, brussel sprouts, cabbage, cauliflower,
cavalo broccolo, Chinese broccoli-gal lon, Chinese cabbage-napa, Chinese
mustard cabbage-gal choy, Kohlrabi, Brussels sprouts, cauliflower)
0.2-0.3	3-4	0.8	7	G, A	7

Citrus	0.2-0.4	2-4	0.8	10	G, Airblast, A	1

Cotton	0.15-0.3	3-5	0.8	7	G, A	21

Cucurbits (balsam apple, balsam pear, bitter melon, chayote, Chinese
cucumber, Chinese waxgourd, citron melon, cucumber, edible gourd,
gherkin, honeydew, Momordica spp., muskmelon, pumpkin, summer squash,
watermelon, winter squash)	0.2-0.3	3-4	0.8	7	G, A	7

Fruiting vegetables (bell pepper, chili pepper, cooking pepper,
eggplant, ground cherry-Physalis spp., pepino, pimento, sweet pepper,
tomatillo, tomato)	0.15-0.2	4-5	0.8	7	G, A	3

Grape	0.1-0.4	2-8	0.8	7	G, A	21

Peanut	0.1-0.3	3-8	0.8	7	G, A	14

Pome fruit (apple, crabapple, loquat, mayhaw, quince, oriental pear,
pear)	0.2-0.4	2-8	0.8	10	Airblast	14

Strawberry	0.2-0.4	2-8	0.8	30	G	2

Pea (English pea, garden pea, green pea, pigeon pea)	0.2	4	0.8	7	G, A	7

Currant	0.2-0.3	3	0.8	7	G	21

Bushberries (blueberry-highbush and lowbush, elderberry, gooseberry,
huckleberry, juneberry, lingonberry, rabbiteye, salal)	0.2-0.3	2	0.6	14
G, A	3

Caneberries (blackberry-including bingleberry, boysenberry, dewberry,
lowberry, marionberry, olallieberry and youngberry; loganberry; black
raspberry; red raspberry)	0.2-0.3	2	0.6	14	G, A	3

Olive	0.2-0.3	3-4	0.8	14	G	7

Stone fruits (such as apricot, cherry, nectarine, peach, plum and prune)
0.2-0.4	2-4	0.8	10	Airblast	14

Tree nut (such as almond, beechnut, cashew, chestnut, chinquapin,
filbert (hazelnut), hickory, macadamia, pecan, pistachio, walnut)
0.2-0.4	2-4	0.8	10	Airblast	14

Barley	0.2	1	0.2	N/A	G	14

Tropical and subtropical fruits (inedible peel, including but not
limited to avocado, canistel, mango, papaya, sapodilla, black and mamey
sapote, star apple)	0.3-0.4	2	0.8	14	G	1

APPENDIX A. Chemical Structure of Fenpropathrin

Fenpropathrin

APPENDIX B.  Copy of Drinking Water Assessment Dated January 22, 2003

C O P Y

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

OFFICE  OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

January 22, 2003

MEMORANDUM

SUBJECT:	IR-4 Tolerance Petition for the Use of Fenpropathrin (PC #
127901) on Bushberry Crop Subgroup 13-B (DP Bar Code: D295472).  Tier I
Estimated Drinking Water Concentrations of Fenpropathrin.

TO:		Shaja Brothers, PM Team Reviewer

Robert Forrest, Chief

Registration Division (7505C)

and		Gary Bangs

Health Effects Division (7509C)

FROM:	José Luis Meléndez, Chemist

Environmental Risk Branch V/EFED

THROUGH:	Mah T. Shamim, Ph.D., Chief

Environmental Risk Branch V

Environmental Fate and Effects Division (7507C)

This memo presents the Tier I Estimated Drinking Water Concentrations
(EDWCs) for fenpropathrin, calculated using FIRST (surface water) and
SCIGROW (ground water) for use in the human health risk assessment.  The
registrant seeks to establish tolerances for use on bushberry crop
(subgroup 13-B).

For surface water, the acute (peak) value is 10.3 ppb and the annual
average value is 1.8 ppb.  The groundwater screening concentration is
<0.006 ppb.  These values generally represent upper-bound estimates of
the concentrations that might be found in surface water and groundwater
due to the use of fenpropathrin on grapes, which represents the scenario
with the highest application rate with the lowest interval between
applications.  Both models provide estimates suitable for screening
purposes.  Additional refinements can be developed should they be needed
by HED.

Use of Fenpropathrin on Bushberry Crops (Subgroup 13-B):

The proposed petition for tolerance for the use of fenpropathrin is for
use in the production of bushberry (subgroup 13B).  The product used is
Danitol 2.4 EC Spray (30.9% a.i.).  It would be used on Blueberries
(highbush and lowbush), Elderberries, Gooseberries, Huckleberries,
Lingonberries, Juneberries, and Salal, for the control of Japanese
Beetle, Blueberry Maggot, and Obliquebanded Leafroller.  Two
applications can be made with 14 day interval at a maximum of 0.3 lb
a.i./A/application, and not to exceed a seasonal application rate of 0.6
lb a.i./A.  According to the submission (section B), the chemical can be
applied by ground methods only.

Background Information on FIRST:

FIRST is a screening model designed to estimate the pesticide
concentrations found in water for use in drinking water assessments.  It
provides high-end values on the concentrations that might be found in a
small drinking water reservoir due to the use of pesticide.  Like
GENEEC, the model previously used for Tier I screening level, FIRST is a
single-event model (one run-off event).  It can also account for spray
drift from multiple applications.  FIRST takes into consideration the so
called Index Drinking Water Reservoir by representing a larger field and
pond than the standard GENEEC scenario.  The FIRST scenario includes a
427 acres field immediately adjacent to a 13 acres reservoir, 9 feet
deep, with continuous flow (two turnovers per year).  The pond receives
a spray drift event from each application plus one runoff event.  The
runoff event moves a maximum of 8% of the applied pesticide into the
pond.  This amount can be reduced due to degradation on field and the
effect of binding to soil.  Spray drift is equal to 6.4% of the applied
concentration from the ground spray application and 16% for aerial
applications.

FIRST also makes adjustments for the percent crop area. While FIRST
assumes that the entire watershed would not be treated, the use of a PCA
is still a screen because it represents the highest percentage of crop
cover of any large watershed in the US, and it assumes that the entire
crop is being treated.  Various other conservative assumptions of FIRST
include the use of a small drinking water reservoir surrounded by a
runoff-prone watershed, the use of the maximum use rate, no buffer zone,
and a single large rainfall.

Background Information on SCIGROW:

SCIGROW  V.2.3 provides a groundwater screening exposure value to be
used in determining the potential risk to human health from drinking
water contaminated with the pesticide.  Since the SCIGROW concentrations
are likely to be approached in only a very small percentage of drinking
water sources, i.e., highly vulnerable aquifers, it is not appropriate
to use SCIGROW for national or regional exposure estimates.

SCIGROW estimates likely groundwater concentrations if the pesticide is
used at the maximum allowable rate in areas where groundwater is
exceptionally vulnerable to contamination.  In most cases, a large
majority of the use area will have groundwater that is less vulnerable
to contamination than the areas used to derive the SCIGROW estimate.

Estimated concentrations of chemicals with Koc values greater than 9995
ml/g are beyond the scope of the regression data used in SCI-GROW
development.  If there are concerns for such chemicals, a higher tier
groundwater exposure assessment should be considered, regardless of the
concentration returned by SCI-GROW.

Modeling Inputs and Results:

Tables 1 and 2 summarize the input values used in the model runs for
FIRST 1.0 and SCIGROW, respectively.  The lowest non-sand KD was used in
FIRST.  The median KOC value was used in SCIGROW.  There was one
available aerobic soil metabolism half-life for fenpropathrin.  Three
times the available half-life was used for the aerobic soil metabolism
input in FIRST.  The modeling results associated with maximum allowable
rate per year (on peanuts, 0.27 lb ai/A applied three times at 7 days
intervals), are presented in Table 3.  Attached to this memo are copies
of the original printouts generated from FIRST and SCIGROW runs.

According to the label, there is a buffer zone of 25 feet between the
treated fields and streams, ponds, lakes, rivers, springs, swamps,
marshes, or irrigation canals containing water year around for ground
applications, and 150 feet for aerial applications.  If ultra low volume
(ULV) application is made, the buffer zone should be increased to 450
feet.

Table 1.	Environmental Fate and Other Input Parameters for the
Estimation of Fenpropathrin using FIRST

Parameter

Value

Source

Water Solubility (25(C)

0.0103 ppm

MRID# 44370001

Hydrolysis Half-Life (pH 7) (stable)

0

MRID# 42599901

Aerobic Soil Metabolism Half-Life (3X available value)

456 days

MRID# 42525902

Aerobic Aquatic Metabolism Half-life (2X aerobic soil input)

912 days

NA

Aqueous Photolysis Half-Life (stable)

0

MRID# 42546402

Coefficient (Lowest non-sand Kd)

212

MRID#.s 42584101 and 44370002

Pesticide is Wetted-In

No

Label

Method of Application

aerial

Label

PCA

0.87

Default for grapes

Depth of Incorporation (Broadcast)

0.0 in.

Label

Table 2.	Environmental Fate Input Parameters for the Estimation of
Fenpropathrin using SCIGROW.

Parameter

Value

Source

Organic Carbon Partition Coefficient (median KOC)

293000

MRID#’s 42584101 and 44370002

Aerobic Soil Metabolism Half-Life (available value)

152 days

MRID# 42525902

Table 3.  Modeling Results for Use of Fenpropathrin on Grapes

Parameter

Grapes

Source

Application Method

aerial

Label

Application Rate

0.4 lb a.i./A

Label

Applications Permitted per Year

2

Label

Application Interval

7 days

N/A

FIRST 1.0 Peak Untreated Water Concentration

10.3 ppb

N/A

FIRST 1.0 Annual Average Untreated Water Concentration

1.8 ppb

N/A

SCIGROW Ground Water Concentration

<0.006 ppb

N/A

Appendix I.	SURFACE WATERS (FIRST) and GROUND WATERS OUTPUT RUNS FOR
GRAPES

	Estimated Surface Water Concentrations for Fenpropathrin

   RUN No.   1 FOR Fenpropathrin    ON   Grapes        * INPUT VALUES *

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

   RATE (#/AC)   No.APPS &   SOIL  SOLUBIL   APPL TYPE  %CROPPED INCORP

    ONE(MULT)    INTERVAL     Kd   (PPB )    (%DRIFT)     AREA    (IN)

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

   .400(   .796)   2   7     212.0   10.3   AERIAL(16.0)  87.0      .0

   FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)

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

   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED

    (FIELD)  RAIN/RUNOFF  (RESERVOIR)  (RES.-EFF)   (RESER.)   (RESER.)

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

    456.00        2          N/A       .00-     .00   912.00    912.00

   UNTREATED WATER CONC (MICROGRAMS/LITER (PPB))    Ver 1.0 AUG 1, 2001

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

        PEAK DAY  (ACUTE)      ANNUAL AVERAGE (CHRONIC)

          CONCENTRATION             CONCENTRATION

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

             10.300                      1.811

	Estimated Ground Water Concentrations for Fenpropathrin

                           SCIGROW

                          VERSION 2.3

            ENVIRONMENTAL FATE AND EFFECTS DIVISION

                 OFFICE OF PESTICIDE PROGRAMS

             U.S. ENVIRONMENTAL PROTECTION AGENCY

                        SCREENING MODEL

                FOR AQUATIC PESTICIDE EXPOSURE

 SciGrow version 2.3

 chemical:Fenpropathrin

 time is  1/20/2004  10:21:32

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

  Application      Number of       Total Use    Koc      Soil Aerobic

  rate (lb/acre)  applications   (lb/acre/yr)  (ml/g)   metabolism
(days)

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

      0.400           2.0           0.800      2.93E+05      152.0

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

 groundwater screening cond (ppb) =   4.80E-03*

 *Estimated concentrations of chemicals with Koc values greater than
9995 ml/g

 are beyond the scope of the regression data used in SCI-GROW
development.

 If there are concerns for such chemicals, a higher tier groundwater
exposure

 assessment should be considered, regardless of the concentration
returned

 by SCI-GROW.

 ***********************************************************************
*

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( PAGE  10 (

  PAGE   11


[Federal Register: May 7, 2007 (Volume 72, Number 87)]
[Notices]
[Page 25809-25823]
[DOCID:fr07my07-94]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-8794; 34-55682]

Order Making Fiscal Year 2008 Annual Adjustments to the Fee Rates
Applicable Under Section 6(b) of the Securities Act of 1933 and
Sections 13(e), 14(g), 31(b), and 31(c) of the Securities Exchange Act
of 1934

April 30, 2007.

I. Background

    The Commission collects fees under various provisions of the
securities laws. Section 6(b) of the Securities Act of 1933
(``Securities Act'') requires the Commission to collect fees from
issuers on the registration of securities.\1\ Section 13(e) of the
Securities Exchange Act of 1934 (``Exchange Act'') requires the
Commission to collect fees on specified repurchases of securities.\2\
Section 14(g) of the Exchange Act requires the Commission to collect
fees on proxy solicitations and statements in corporate control
transactions.\3\ Finally, Sections 31(b) and (c) of the Exchange Act
require national securities exchanges and national securities
associations, respectively, to pay fees to the

Commission on transactions in specified securities.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 77f(b).
    \2\ 15 U.S.C. 78m(e).
    \3\ 15 U.S.C. 78n(g).
    \4\ 15 U.S.C. 78ee(b) and (c). In addition, Section 31(d) of the
Exchange Act requires the Commission to collect assessments from
national securities exchanges and national securities associations
for round turn transactions on security futures. 15 U.S.C. 78ee(d).
---------------------------------------------------------------------------

    The Investor and Capital Markets Fee Relief Act (``Fee Relief
Act'') \5\ amended Section 6(b) of the Securities Act and Sections
13(e), 14(g), and 31 of the Exchange Act to require the Commission to
make annual adjustments to the fee rates applicable under these
sections for each of the fiscal years 2003 through 2011, and one final
adjustment to fix the fee rates under these sections for fiscal year
2012 and beyond.\6\
---------------------------------------------------------------------------

    \5\ Pub. L. No. 107-123, 115 Stat. 2390 (2002).
    \6\ See 15 U.S.C. 77f(b)(5), 77f(b)(6), 78m(e)(5), 78m(e)(6),
78n(g)(5), 78n(g)(6), 78ee(j)(1), and 78ee(j)(3). Section 31(j)(2)
of the Exchange Act, 15 U.S.C. 78ee(j)(2), also requires the
Commission, in specified circumstances, to make a mid-year
adjustment to the fee rates under Sections 31(b) and (c) of the
Exchange Act in fiscal years 2002 through 2011.
---------------------------------------------------------------------------

II. Fiscal Year 2008 Annual Adjustment to the Fee Rates Applicable
Under Section 6(b) of the Securities Act and Sections 13(e) and 14(g)
of the Exchange Act

    Section 6(b)(5) of the Securities Act requires the Commission to
make an annual adjustment to the fee rate applicable under Section 6(b)
of the Securities Act in each of the fiscal years 2003 through 2011.\7\
In those same fiscal years, Sections 13(e)(5) and 14(g)(5) of the
Exchange Act require the Commission to adjust the fee rates under
Sections 13(e) and 14(g) to a rate that is equal to the rate that is
applicable under Section 6(b). In other words, the annual adjustment to
the fee rate under Section 6(b) of the Securities Act also sets the
annual adjustment to the fee rates under Sections 13(e) and 14(g) of
the Exchange Act.
---------------------------------------------------------------------------

    \7\ The annual adjustments are designed to adjust the fee rate
in a given fiscal year so that, when applied to the aggregate
maximum offering price at which securities are proposed to be
offered for the fiscal year, it is reasonably likely to produce
total fee collections under Section 6(b) equal to the ``target
offsetting collection amount'' specified in Section 6(b)(11)(A) for
that fiscal year.
---------------------------------------------------------------------------

    Section 6(b)(5) sets forth the method for determining the annual
adjustment to the fee rate under Section 6(b) for fiscal year 2008.
Specifically, the Commission must adjust the fee rate under Section
6(b) to a ``rate that, when applied to the baseline estimate of the
aggregate maximum offering prices for [fiscal year 2008], is reasonably
likely to produce aggregate fee collections under [Section 6(b)] that
are equal to the target offsetting collection amount for [fiscal year
2008].'' That is, the adjusted rate is determined by dividing the
``target offsetting collection amount'' for fiscal year 2008 by the
``baseline estimate of the aggregate maximum offering prices'' for
fiscal year 2008.
    Section 6(b)(11)(A) specifies that the ``target offsetting
collection amount'' for fiscal year 2008 is $234,000,000.\8\ Section
6(b)(11)(B) defines the ``baseline estimate of the aggregate maximum
offering price'' for fiscal year 2008 as ``the baseline estimate of the
aggregate maximum offering price at which securities are proposed to be
offered pursuant to registration statements filed with the Commission
during [fiscal year 2008] as determined by the Commission, after
consultation with the Congressional Budget Office and the Office of
Management and Budget * * *.''
---------------------------------------------------------------------------

    \8\ Congress determined the target offsetting collection amounts
by applying reduced fee rates to the CBO's January 2001 projections
of the aggregate maximum offering prices for fiscal years 2002
through 2011. In any fiscal year through fiscal year 2011, the
annual adjustment mechanism will result in additional fee rate
reductions if the CBO's January 2001 projection of the aggregate
maximum offering prices for the fiscal year proves to be too low,
and fee rate increases if the CBO's January 2001 projection of the
aggregate maximum offering prices for the fiscal year proves to be
too high.
---------------------------------------------------------------------------

    To make the baseline estimate of the aggregate maximum offering
price for fiscal year 2008, the Commission is using the same
methodology it developed in consultation with the Congressional Budget
Office (``CBO'') and Office of Management and Budget (``OMB'') to
project aggregate offering price for purposes of the fiscal year 2007
annual adjustment. Using this methodology, the Commission determines
the ``baseline estimate of the aggregate maximum offering price'' for
fiscal year 2008 to be $5,959,775,433,491.\9\ Based on this estimate,
the Commission calculates the fee rate for fiscal 2008 to be $39.30 per
million. This adjusted fee rate applies to Section 6(b) of the
Securities Act, as well as to Sections 13(e) and 14(g) of the Exchange
Act.
---------------------------------------------------------------------------

    \9\ Appendix A explains how we determined the ``baseline
estimate of the aggregate maximum offering price'' for fiscal year
2008 using our methodology, and then shows the purely arithmetical
process of calculating the fiscal year 2008 annual adjustment based
on that estimate. The appendix includes the data used by the
Commission in making its ``baseline estimate of the aggregate
maximum offering price'' for fiscal year 2008.
---------------------------------------------------------------------------

III. Fiscal Year 2008 Annual Adjustment to the Fee Rates Applicable
Under Sections 31(b) and (c) of the Exchange Act

    Section 31(b) of the Exchange Act requires each national securities
exchange to pay the Commission a fee at a rate, as adjusted by our
order pursuant to Section 31(j)(2),\10\ which currently is $15.30 per
million of the aggregate dollar amount of sales of specified securities
transacted on the exchange. Similarly, Section 31(c) requires each
national securities association to pay the Commission a fee at the same
adjusted rate on the aggregate dollar amount of sales of specified
securities transacted by or through any member of the association
otherwise than on an exchange. Section 31(j)(1) requires the Commission
to make annual adjustments to the fee rates applicable under Sections
31(b) and (c) for each of the fiscal years 2003 through 2011.\11\
---------------------------------------------------------------------------

    \10\ Order Making Fiscal Year 2007 Annual Adjustments to the Fee
Rates Applicable under Section 6(b) of the Securities Act of 1933
and Sections 13(e), 14(g), 31(b) and 31(c) of the Securities
Exchange Act of 1934, Rel. No. 33-8681 (April 28, 2006), 71 FR 26132
(May 3, 2006).
    \11\ The annual adjustments, as well as the mid-year adjustments
required in specified circumstances under Section 31(j)(2) in fiscal
years 2002 through 2011, are designed to adjust the fee rates in a
given fiscal year so that, when applied to the aggregate dollar
volume of sales for the fiscal year, they are reasonably likely to
produce total fee collections under Section 31 equal to the ``target
offsetting collection amount'' specified in Section 31(l)(1) for
that fiscal year.
---------------------------------------------------------------------------

    Section 31(j)(1) specifies the method for determining the annual
adjustment for fiscal year 2008. Specifically, the Commission must
adjust the rates under Sections 31(b) and (c) to a ``uniform adjusted
rate that, when applied to the baseline estimate of the aggregate
dollar amount of sales for [fiscal year 2008], is reasonably likely to
produce aggregate fee collections under [Section 31] (including
assessments collected under [Section 31(d)]) that are equal to the
target offsetting collection amount for [fiscal year 2008].''
    Section 31(l)(1) specifies that the ``target offsetting collection
amount'' for fiscal year 2008 is $892,000,000.\12\ Section 31(l)(2)
defines the ``baseline estimate of the aggregate dollar amount of
sales'' as ``the baseline estimate of the aggregate dollar amount of
sales of securities * * * to be transacted on each national securities
exchange and by or through any member of each national securities
association (otherwise than on a national securities

exchange) during [fiscal year 2008] as determined by the Commission,
after consultation with the Congressional Budget Office and the Office
of Management and Budget * * *.''
---------------------------------------------------------------------------

    \12\ Congress determined the target offsetting collection
amounts by applying reduced fee rates to the CBO's January 2001
projections of dollar volume for fiscal years 2002 through 2011. In
any fiscal year through fiscal year 2011, the annual and, in
specified circumstances, mid-year adjustment mechanisms will result
in additional fee rate reductions if the CBO's January 2001
projection of dollar volume for the fiscal year proves to be too
low, and fee rate increases if the CBO's January 2001 projection of
dollar volume for the fiscal year proves to be too high.
---------------------------------------------------------------------------

    To make the baseline estimate of the aggregate dollar amount of
sales for fiscal year 2008, the Commission is using the same
methodology it developed in consultation with the CBO and OMB to
project dollar volume for purposes of prior fee adjustments.\13\ Using
this methodology, the Commission calculates the baseline estimate of
the aggregate dollar amount of sales for fiscal year 2008 to be
$78,732,152,559,457. Based on this estimate, and an estimated
collection of $18,017 in assessments on security futures transactions
under Section 31(d) in fiscal year 2008, the uniform adjusted rate for
fiscal year 2008 is 11.00 per million.\14\
---------------------------------------------------------------------------

    \13\ Appendix B explains how we determined the ``baseline
estimate of the aggregate dollar amount of sales'' for fiscal year
2007 using our methodology, and then shows the purely arithmetical
process of calculating the fiscal year 2007 annual adjustment based
on that estimate. The appendix also includes the data used by the
Commission in making its ``baseline estimate of the aggregate dollar
amount of sales'' for fiscal year 2007.
    \14\ The calculation of the adjusted fee rate assumes that the
current fee rate of $15.30 per million will apply through October
31, 2007, due to the operation of the effective date provision
contained in Section 31(j)(4)(A) of the Exchange Act.
---------------------------------------------------------------------------

IV. Effective Dates of the Annual Adjustments

    Section 6(b)(8)(A) of the Securities Act provides that the fiscal
year 2008 annual adjustment to the fee rate applicable under Section
6(b) of the Securities Act shall take effect on the later of October 1,
2007, or five days after the date on which a regular appropriation to
the Commission for fiscal year 2008 is enacted.\15\ Section 13(e)(8)(A)
and 14(g)(8)(A) of the Exchange Act provide for the same effective date
for the annual adjustments to the fee rates applicable under Sections
13(e) and 14(g) of the Exchange Act.\16\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 77f(b)(8)(A).
    \16\ 15 U.S.C. 78m(e)(8)(A) and 78n(g)(8)(A).
---------------------------------------------------------------------------

    Section 31(j)(4)(A) of the Exchange Act provides that the fiscal
year 2008 annual adjustments to the fee rates applicable under Sections
31(b) and (c) of the Exchange Act shall take effect on the later of
October 1, 2007, or 30 days after the date on which a regular
appropriation to the Commission for fiscal year 2008 is enacted.

V. Conclusion

    Accordingly, pursuant to Section 6(b) of the Securities Act and
Sections 13(e), 14(g), and 31 of the Exchange Act,\17\
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 77f(b), 78m(e), 78n(g), and 78ee(j).
---------------------------------------------------------------------------

    It is hereby ordered that the fee rates applicable under Section
6(b) of the Securities Act and Sections 13(e) and 14(g) of the Exchange
Act shall be $39.30 per million effective on the later of October 1,
2007, or five days after the date on which a regular appropriation to
the Commission for fiscal year 2008 is enacted; and
    It is further ordered that the fee rates applicable under Sections
31(b) and (c) of the Exchange Act shall be $11.00 per million effective
on the later of October 1, 2007, or 30 days after the date on which a
regular appropriation to the Commission for fiscal year 2008 is
enacted.

    By the Commission.
Nancy M. Morris,
Secretary.

Appendix A

    With the passage of the Investor and Capital Markets Relief Act,
Congress has, among other things, established a target amount of
monies to be collected from fees charged to issuers based on the
value of their registrations. This appendix provides the formula for
determining such fees, which the Commission adjusts annually.
Congress has mandated that the Commission determine these fees based
on the ``aggregate maximum offering prices,'' which measures the
aggregate dollar amount of securities registered with the Commission
over the course of the year. In order to maximize the likelihood
that the amount of monies targeted by Congress will be collected,
the fee rate must be set to reflect projected aggregate maximum
offering prices. As a percentage, the fee rate equals the ratio of
the target amounts of monies to the projected aggregate maximum
offering prices.
    For 2008, the Commission has estimated the aggregate maximum
offering prices by projecting forward the trend established in the
previous decade. More specifically, an ARIMA model was used to
forecast the value of the aggregate maximum offering prices for
months subsequent to March 2007, the last month for which the
Commission has data on the aggregate maximum offering prices.
    The following sections describe this process in detail.

A. Baseline Estimate of the Aggregate Maximum Offering Prices for
Fiscal Year 2008

    First, calculate the aggregate maximum offering prices (AMOP)
for each month in the sample (March 1997-March 2007). Next,
calculate the percentage change in the AMOP from month to month.
    Model the monthly percentage change in AMOP as a first order
moving average process. The moving average approach allows one to
model the effect that an exceptionally high (or low) observation of
AMOP tends to be followed by a more ``typical'' value of AMOP.
    Use the estimated moving average model to forecast the monthly
percent change in AMOP. These percent changes can then be applied to
obtain forecasts of the total dollar value of registrations. The
following is a more formal (mathematical) description of the
procedure:
    1. Begin with the monthly data for AMOP. The sample spans ten
years, from March 1997 to March 2007.
    2. Divide each month's AMOP (column C) by the number of trading
days in that month (column B) to obtain the average daily AMOP
(AAMOP, column D).
    3. For each month t, the natural logarithm of AAMOP is reported
in column E.
    4. Calculate the change in log(AAMOP) from the previous month as
[Delta]t = log (AAMOPt) -
log(AAMOPt-1). This approximates the percentage change.
    5. Estimate the first order moving average model
[Delta]t = [alpha] + [beta]et-1 +
et, where et denotes the forecast error for
month t. The forecast error is simply the difference between the
one-month ahead forecast and the actual realization of
[Delta]t. The forecast error is expressed as
et = [Delta]t - [alpha] -
[beta]t-1. The model can be estimated using standard
commercially available software such as SAS or Eviews. Using least
squares, the estimated parameter values are [alpha] = 0.00781 and
[beta] = -0.76766.
    6. For the month of April 2007 forecast
[Delta]t = 4/07 = [alpha] + [beta]et = 3/07.
For all subsequent months, forecast [Delta]t = [alpha].
    7. Calculate forecasts of log(AAMOP). For example, the forecast
of log(AAMOP) for June 2007 is given by FLAAMOP t = 6/07
= log(AAMOP t = 3/07) + [Delta] t = 4/07 +
[Delta]t = 5/07 + [Delta]t = 6/07.
    8. Under the assumption that et is normally
distributed, the n-step ahead forecast of AAMOP is given by
exp(FLAAMOPt + [sigma]n2/2), where
[sigma]n denotes the standard error of the n-step ahead
forecast.
    9. For June 2007, this gives a forecast AAMOP of $21.2 Billion
(Column I), and a forecast AMOP of $444.9 Billion (Column J).
    10. Iterate this process through September 2008 to obtain a
baseline estimate of the aggregate maximum offering prices for
fiscal year 2008 of $5,959,775,433,491.

B. Using the Forecasts From A to Calculate the New Fee Rate

    1. Using the data from Table A, estimate the aggregate maximum
offering prices between 10/1/07 and 9/30/08 to be
$5,959,775,433,491.
    2. The rate necessary to collect the target $234,000,000 in fee
revenues set by Congress is then calculated as: $234,000,000 /
$5,959,775,433,491 = 0.00003926 (or $39.30 per million.).
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BILLING CODE 8010-01-C

Appendix B

    With the passage of the Investor and Capital Markets Relief Act,
Congress has, among other things, established a target amount of
monies to be collected from fees charged to investors based on the
value of their transactions. This appendix provides the formula for
determining such fees, which the Commission adjusts annually, and
may adjust semi-annually.\18\ In order to maximize the likelihood
that the amount of monies targeted by Congress will be collected,
the fee rate must be set to reflect projected dollar transaction
volume on the securities exchanges and certain over-the-counter
markets over the course of the year. As a percentage, the fee rate
equals the ratio of the target amounts of monies to the projected
dollar transaction volume.
---------------------------------------------------------------------------

    \18\ Congress requires that the Commission make a mid-year
adjustment to the fee rate if four months into the fiscal year it
determines that its forecasts of aggregate dollar volume are
reasonably likely to be off by 10% or more.
---------------------------------------------------------------------------

    For 2008, the Commission has estimated dollar transaction volume
by projecting forward the trend established in the previous decade.
More specifically, dollar transaction volume was forecasted for
months subsequent to March 2007, the last month for which the
Commission has data on transaction volume.
    The following sections describe this process in detail.

A. Baseline Estimate of the Aggregate Dollar Amount of Sales for
Fiscal Year 2008

    First, calculate the average daily dollar amount of sales (ADS)
for each month in the sample (March 1997-March 2007). The monthly
aggregate dollar amount of sales (exchange plus certain over-the-
counter markets) is presented in column C of Table B.
    Next, calculate the change in the natural logarithm of ADS from
month to month. The average monthly percentage growth of ADS over
the entire sample is 0.014 and the standard deviation 0.115.
Assuming the monthly percentage change in ADS follows a random walk,
calculating the expected monthly percentage growth rate for the full
sample is straightforward. The expected monthly percentage growth
rate of ADS is 2.1%.
    Now, use the expected monthly percentage growth rate to forecast
total dollar volume. For example, one can use the ADS for March 2007
($238,343,650,750) to forecast ADS for April 2007 ($243,433,544,609
= $238,343,650,750 x 1.021).\19\ Multiply by the number of trading
days in April 2007 (20) to obtain a forecast of the total dollar
volume for the month ($4,868,670,892,189). Repeat the method to
generate forecasts for subsequent months.
---------------------------------------------------------------------------

    \19\ The value 1.021 has been rounded. All computations are done
with the unrounded value.
---------------------------------------------------------------------------

    The forecasts for total dollar volume are in column G of Table
B. The following is a more formal (mathematical) description of the
procedure:
    1. Divide each month's total dollar volume (column C) by the
number of trading days in that month (column B) to obtain the
average daily dollar volume (ADS, column D).
    2. For each month t, calculate the change in ADS from the
previous month as [Delta]t = log (ADSt /
ADSt-1), where log (x) denotes the natural logarithm of
x.
    3. Calculate the mean and standard deviation of the series
{[Delta]1, [Delta]2, * * *
[Delta]120{time} . These are given by [mu] = 0.014 and
[sigma] = 0.115, respectively.
    4. Assume that the natural logarithm of ADS follows a random
walk, so that [Delta]s and [Delta]t are
statistically independent for any two months s and t.
    5. Under the assumption that [Delta]t is normally
distributed, the expected value of ADSt/ADSt-1
is given by exp ([mu] + [sigma]\2\/2), or on average ADSt
= 1.021 x ADSt-1.
    6. For April 2007, this gives a forecast ADS of 1.021 x
$238,343,650,750 = $243,433,544,609. Multiply this figure by the 20
trading days in April 2007 to obtain a total dollar volume forecast
of $4,868,670,892,189.
    7. For May 2007, multiply the April 2007 ADS forecast by 1.021
to obtain a forecast ADS of $248,632,134,545. Multiply this figure
by the 22 trading days in May 2007 to obtain a total dollar volume
forecast of $5,469,906,959,979.
    8. Repeat this procedure for subsequent months.

B. Using the Forecasts From A to Calculate the New Fee Rate

    1. Use Table B to estimate fees collected for the period 10/1/07
through 10/31/07. The projected aggregate dollar amount of sales for
this period is $6,355,786,096,164. Projected fee collections at the
current fee rate of 0.0000153 are $97,243,527.
    2. Estimate the amount of assessments on securities futures
products collected during 10/1/07 and 9/30/08 to be $18,017 by
projecting a 2.1% monthly increase from a base of $1,150 in March
2007.
    3. Subtract the amounts $97,243,527 and $18,017 from the target
offsetting collection amount set by Congress of $892,000,000 leaving
$794,738,456 to be collected on dollar volume for the period 11/1/07
through 9/30/08.
    4. Use Table B to estimate dollar volume for the period 11/1/07
through 9/30/08. The estimate is $72,376,366,463,293. Finally,
compute the fee rate required to produce the additional $794,738,456
in revenue. This rate is $794,738,456 divided by $72,376,366,463,293
or 0.0000109806.
    5. Round the result to the seventh decimal point, yielding a
rate of .0000110 (or $11.00 per million).
BILLING CODE 8010-01-P

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[FR Doc. 07-2194 Filed 5-4-07; 8:45 am]

BILLING CODE 8010-01-C


[Federal Register: May 1, 2008 (Volume 73, Number 85)]
[Notices]
[Page 24079-24080]
[DOCID:fr01my08-61]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1751-DR]

Arkansas; Amendment No. 5 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Arkansas (FEMA-1751-DR), dated March 26, 2008, and
related determinations.

DATES: Effective Date: April 22, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, 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 Arkansas is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the catastrophe declared a major disaster by the President in his
declaration of March 26, 2008.

    Cleburne, Jefferson, Lee, Miller, Phillips, and Sebastian
Counties for Individual Assistance.
    Crawford, St. Francis, and White Counties for Individual
Assistance (already designated for Public Assistance.)
    Searcy and Yell Counties for Individual Assistance (already
designated for Public

Assistance, including direct Federal assistance.)
    Clark, Cleburne, Lee, Little River, Mississippi, Phillips, and
Pike Counties for Public Assistance.
    Hot Spring and Washington Counties for Public Assistance
(already designated for Individual Assistance and emergency
protective measures [Category B], limited to direct Federal
assistance, under the Public Assistance program.)

(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
Presidential Declared Disaster Areas; 97.049, Presidential Declared
Disaster Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidential Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
 [FR Doc. E8-9533 Filed 4-30-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register: August 4, 2008 (Volume 73, Number 150)]
[Notices]
[Page 45270]
[DOCID:fr04au08-92]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2008-30]

Petition for Exemption; Summary of Petition Received; Correction

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received; correction.

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

SUMMARY: This notice corrects the docket number of a previously-
published petition for exemption. It also extends the comment period
for the petition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before August 25, 2008.

ADDRESSES: You may send comments identified by Docket Number FAA2007-
0323, using any of the following methods:
     Government-wide rulemaking Web site: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
(202) 493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Kenna Sinclair<PHONE_NUMBER>,
Transport Airplane Directorate, ANM-113, Federal Aviation
Administration, 1601 Lind Avenue, SE., Renton, WA 98055-4056, or
Frances Shaver<PHONE_NUMBER>, Office of Rulemaking, ARM-204, Federal
Aviation Administration, 800 Independence Avenue, SW., Washington, DC
20591.

SUPPLEMENTARY INFORMATION:

Background

    On July 25, 2008 (73 FR 43484), the FAA published a petition for
exemption from the Boeing Company (PE-2008-30). However, the FAA docket
number listed for this petition was incorrect. This notice corrects the
docket number. In addition, the FAA is extending the comment period for
this petition until August 25, 2008 since the lack of a correct docket
number may have prevented interested parties from being able to submit
their comments.

The Correction

    1. In the issue of July 25, 2008, on page 43484, in the second
column, in the ADDRESSES section, the Docket Number should read FAA-
2007-0323.
    2. On page 43484, third column, under the heading ``Petition for
Exemption'', the Docket number should read FAA-2007-0232.

    Issued in Washington, DC on July 30, 2008.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2007-0323.
    Petitioner: The Boeing Company.
    Section of 14 CFR Affected: Sec. Sec.  25.857(e), 25.785(j), and
25.1447(c)(1).
    Description of Relief Sought: The Boeing Company requests exemption
from the airworthiness standards for transport category airplanes that
would allow up to eleven (11) supernumeraries to access the main deck
cargo compartment on a Boeing Model 777F airplane for all types of
cargo operations, namely: (1) Cargo only, (2) live animals only, and
(3) mixed cargo consisting of live animals and regular cargo.

[FR Doc. E8-17823 Filed 8-1-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 72 (Monday, April 15, 2019)]
[Notices]
[Pages 15228-15229]
[FR Doc No: 2019-07405]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2019-0138]

Boston Area Maritime Security Advisory Committee; Vacancies,
Coast Guard Sector Boston, MA

AGENCY: Coast Guard, Department of Homeland Security.

ACTION: Solicitation for membership.

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

SUMMARY: This notice requests individuals interested in serving on the
Boston Area Maritime Security Committee (AMSC) to submit their
applications for membership, to the Captain of the Port (COTP), Boston,
MA.

DATES: Requests for membership should reach the U.S. Coast Guard COTP
Boston May 15, 2019.

ADDRESSES: Applications for membership should be submitted to the
Captain of the Port Boston at the following address: Commander (sx),
USCG Sector Boston, 427 Commercial Street, Boston, MA 02109 or by email
to [email protected].

FOR FURTHER INFORMATION CONTACT: For questions about submitting an
application or about the AMSC in general, contact Mr. Ron Catudal at
617-223-5727 or by email to [email protected].

SUPPLEMENTARY INFORMATION:

Authority

    Section 102 of the Maritime Transportation Security Act (MTSA) of
2002 (Pub. L. 107-295) added section 70112 to Title 46 of the U.S.
Code, and authorized the Secretary of the Department in which the Coast
Guard is operating to establish Area Maritime Security Advisory
Committees for any port area of the United States. Under 46 U.S.C.
70112(b)(7), the Federal Advisory Committee Act (FACA) does not apply
to AMSCs.

Boston AMSC Purpose

    The AMSCs shall assist the Captain of the Port in the development,
review, update, and exercise of the Area Maritime Security Plan for
their area of responsibility. Such matters may include, but are not
limited to: Identifying critical port infrastructure and operations;
Identifying risks (threats, vulnerabilities, and consequences);
Determining mitigation strategies and implementation methods;
Developing strategies to facilitate the recovery of the MTS after a
Transportation Security Incident; Developing and describing the process
to continually evaluate overall port security by considering
consequences and vulnerabilities, how they may change over time, and
what additional mitigation strategies can be applied

AMSC Composition

    The composition of an AMSC, to include the Boston AMSC, is
prescribed under 33 CFR 103.305. Pursuant to that

regulation, members may be selected from the Federal, Territorial, or
Tribal government; the State government and political subdivisions of
the State; local public safety, crisis management, and emergency
response agencies; law enforcement and security organizations; maritime
industry, including labor; other port stakeholders having a special
competence in maritime security; and port stakeholders affected by
security practices and policies. Also, at least 7 of the AMSC members
must each have 5 or more years of experience related to maritime or
port security operations.

AMSC Membership

    The Boston AMSC has 41 members who represent Federal, State, local,
and industry stakeholders from Massachusetts. We are seeking to fill
sixteen positions with this solicitation for 2019, twelve of which are
due to expire in 2019.
    Applicants may be required to pass an appropriate security
background check prior to appointment to the committee. Members' terms
of office will be for 5 years; however, a member is eligible to serve
additional terms of office. Members will not receive any salary or
other compensation for their service on an AMSC.

Request for Applications

    Those seeking membership are not required to submit formal
applications to the local Captain of the Port, however, because we do
have an obligation to ensure that a specific number of members have the
prerequisite maritime security experience, we encourage the submission
of resumes highlighting experience in the maritime and security
industries.
    The Department of Homeland Security does not discriminate in
selection of Committee members on the basis of race, color, religion,
sex, national origin, political affiliation, sexual orientation, gender
identity, marital status, disability and genetic information, age,
membership in an employee organization, or other non-merit factor. The
Department of Homeland Security strives to achieve a widely diverse
candidate pool for all of its recruitment actions.

    Dated: April 10, 2019.
Eric J. Doucette,
Captain, U.S. Coast Guard, Captain of the Port Boston, Federal Maritime
Security Coordinator Boston.
[FR Doc. 2019-07405 Filed 4-12-19; 8:45 am]
BILLING CODE 4910-15-P


[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Proposed Rules]
[Page 73014-73015]
[DOCID:fr29no10-33]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 61

Notice of Public Meeting: Updating the Flight Instructor Renewal
Process To Enhance Safety of Flight

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of public meeting.

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SUMMARY: The FAA announces a public meeting to receive industry input
as to how to improve the Certificated Flight Instructor (CFI) biennial
renewal process to enhance the safety of flight in the General Aviation
(GA) community. This is an information gathering meeting.

DATES: The public meetings will be held on the following dates.
     December 6, 2010, from 9 a.m. until no later than 4 p.m.,
and
     December 7, 2010 from 9 p.m. until no later than 4 p.m.

ADDRESSES: The December 6 and 7, 2010, public meetings will be held at
the FAA headquarters building B, located at 600 Independence Avenue,
SW., Washington, DC 20591.
    Because of limited capacity, we ask that all those who anticipate
attending the meeting contact<EMAIL_ADDRESS>with written
confirmation of attendance and the number of members in the attending
party. If we find that we are nearing capacity, we may request that
those who are planning on sending more than a single representative
reduce the number in their party. If this is the case, respondents will
be notified by e-mail and/or phone prior to the meeting date.

FOR FURTHER INFORMATION CONTACT: Requests to attend this public
meeting, questions regarding the logistics of the meeting, and any
technical questions should be directed to Inspector Gregory French,
AFS-800, General Aviation and Commercial Division, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone<PHONE_NUMBER>, facsimile<PHONE_NUMBER>, or, preferably, via
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA has been reviewing safety of flight data in the general
aviation (GA) community over the last ten years. Even with the advent
of new technologies to assist the GA pilot, there has been little
improvement in the accident/incident rate among that community of
aviators.
    CFIs are responsible for ensuring that pilots are properly educated
to operate safely within the National Airspace System (NAS). For CFIs
to accomplish that mission effectively they must be provided the means
and knowledge to do so, and there must be some objective method of
measuring that information transfer and retention. The FAA has been
reviewing indicators that suggest that the processes currently in place
may lack sufficient effectiveness in ensuring that CFIs are being
provided the best information in the most useful manner. This meeting
will elicit input from the community of authorized flight instructor
renewal program operators so that the FAA can better analyze how to
improve the process.

Purpose of the Public Meeting

    The purpose of this public meeting is for the FAA to hear the
public's views and obtain information relevant to improving the CFI
biennial renewal process. The FAA will consider comments made at this
public meeting before making decisions on any suggested changes to the
current policy.
    More specifically, the FAA seeks information on the following
questions. The FAA requests that that all meeting participants provide
written comments to support any positions they may express support for,
or disagreement with.
     How effective have Flight Instructor Refresher Clinics
been in transferring relevant information to flight instructors?
     What can be done to improve the effectiveness of flight
instructor refresher clinics?
     How effective are the written tests provided at the
conclusion of flight instructor refresher clinics?
     How can the effectiveness of flight instructor knowledge
be better assessed?
     How effective have the online courses been?
     How do we effectively measure the success of knowledge
transfer in online flight instructor renewal courses?
     Should there be changes to 14 CFR part 61.197?
     Are those non-FIRC methods of CFI biennial certificate
renewal found in 14 CFR part 61.197 adequate and effective in ensuring
that CFIs possess the most up to date information in terms of both
proficiency and knowledge?
     What can the community conducting flight instructor
recurrent training, the FIRC providers, do to contribute to enhancing
safety of flight among the GA community at large?

Participation at the Public Meetings

    Commenters who wish to present oral statements at the December 6
and 7, 2010, public meetings will be permitted to do so on an ad-hoc
basis during the meeting.
    The FAA will have available a projector and a computer capable of
accommodating Word and PowerPoint presentations from a compact disk
(CD) or USB memory device. Persons requiring any other kind of
audiovisual equipment should notify the FAA prior to the meeting.
    Sign and oral interpretation can be made available at the meeting,
as well

as an assistive listening device, if requested 10 calendar days before
the meeting.

Public Meeting Procedures

    A panel of representatives from the FAA will be present. An FAA
representative will facilitate the meetings in accordance with the
following procedures:
    (1) The meetings are designed to facilitate the public input on
policies that directly affect them. The meetings will be informal and
non-adversarial. No individual will be subject to cross-examination by
any other participant. Government representatives on the panel may ask
questions to clarify statements and to ensure an accurate record. Any
statement made during the meetings by a panel member should not be
construed as an official position of the government.
    (2) There will be no admission fees or other charges to attend or
to participate in the public meetings. The meetings will be open to all
persons, subject to availability of space in the meeting room. The FAA
will make every effort to accommodate all persons wishing to attend.
The FAA asks that participants sign in at 9 a.m. on each day of the
meeting being attended. The FAA will try to accommodate all speakers;
however if available time does not allow this, speakers will be
scheduled on a first-come-first-served basis. The FAA reserves the
right to exclude some speakers, if necessary, to obtain balanced
viewpoints. The meetings may adjourn early if scheduled speakers
complete their statements in less time than is scheduled for the
meetings.
    (3) The FAA will prepare agendas of speakers and presenters and
make the agendas available at the meetings.
    (4) The meeting is intended to produce an environment conducive to
an exchange of ideas. If speakers wish to give dedicated presentations,
they may be limited to 5-10-minute statements. If possible, the FAA
will notify speakers if additional time is available.
    (5) The FAA will review and consider all material presented by
participants at the public meetings. Position papers or materials
presenting views or information related to the topics discussed may be
accepted at the discretion of the presiding officer and will be
subsequently placed in the public docket. If the attendees wish to
provide written materials, the FAA requests that the presenters provide
at least 10 copies of all materials for distribution to the panel
members. Presenters may provide other copies to the audience at their
discretion.
    (6) Each person presenting comments is asked to submit data to
support the comments. The FAA will protect from disclosure all
proprietary data submitted in accordance with applicable laws.

    Issued in Washington, DC on November 18, 2010.
Melvin O. Cintron,
Manager, General Aviation and Commercial Division.
[FR Doc. 2010-29921 Filed 11-26-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 2, 2009 (Volume 74, Number 210)]
[Notices]
[Page 56652]
[DOCID:fr02no09-66]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2009-N-0664]

Pediatric Advisory Committee; Amendment of Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Pediatric Advisory Committee. This
meeting was announced in the Federal Register of October 6, 2009 (74 FR
51289). The amendment is being made to reflect a change in the Agenda
portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT:  Doreen Kezer, Office of Medical and
Scientific Programs, Office of the Commissioner, Food and Drug
Administration, 5600 Fishers Lane (HF-33), rm. 14-65, Rockville, MD
20857,<PHONE_NUMBER>, or FDA Advisory Committee Information Line, 1-800-
741-8138<PHONE_NUMBER> in the Washington, DC area), code<PHONE_NUMBER>.
Please call the Information Line for up-to-date information on this
meeting.

SUPPLEMENTARY INFORMATION:  In the Federal Register of October 6, 2009,
FDA announced that a meeting of the Pediatric Advisory Committee would
be held on December 8, 2009. On page 51290, in the first column, the
Agenda portion of the document is changed to read as follows:
    Agenda: On December 8, 2009, the Pediatric Advisory Committee will
meet to discuss pediatric-focused safety reviews, as mandated by the
Best Pharmaceuticals for Children Act and the Pediatric Research Equity
Act, for Abilify (aripiprazole), Argatroban (argatroban), Orencia
(abatacept), Humira (adalimumab), Cancidas (caspofungin acetate),
Evicel--fibrin sealant (human), Artiss--fibrin sealant (human),
Voluven--6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
injection, Reyataz (atazanavir sulfate), Kaletra (lopinavir/
ritonavir), Aptivus (tipranavir), Zetia (ezetimibe), Vytorin
(ezetimibe/simvastatin), Ventolin HFA (albuterol sulfate). An update to
address some of the committee's questions from the Pediatric Advisory
Committee meeting of November 18, 2008, on atypical antipsychotic drugs
will be provided. In addition to Abilify (aripiprazole), Risperidal
(risperidone), Zyprexa (olanzapine), Geodon (ziprasidone), and Seroquel
(quetiapine) will be included. Two products (Zemuron (rocuronium
bromide) and Cardiolite (technetium Tc99m sestamibi) previously planned
for presentation at this meeting are rescheduled for a later date.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: October 27, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26262 Filed 10-30-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Rules and Regulations]
[Page 30936]
[FR Doc No: 2015-13133]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2015-0210]

Safety Zone; Fourth of July Fireworks, City of Eureka, Humboldt
Bay, Eureka, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zone for the Fourth of
July Fireworks, City of Eureka in the Captain of the Port, San
Francisco area of responsibility during the dates and times noted
below. This action is necessary to protect life and property of the
maritime public from the hazards associated with the fireworks display.
During the enforcement period, unauthorized persons or vessels are
prohibited from entering into, transiting through, or anchoring in the
safety zone, unless authorized by the Patrol Commander (PATCOM).

DATES: The regulations in 33 CFR 165.1191, Table 1, Item number 3, will
be enforced from 12 p.m. on July 3, 2015 through 10:40 p.m. on July 4,
2015.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Lieutenant Junior Grade Joshua Dykman, Sector San
Francisco Waterways Safety Division, U.S. Coast Guard; telephone 415-
399-3585, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a safety zone
in navigable waters around and under the fireworks barge within a
radius of 100 feet during the loading, transit, and arrival of the
fireworks barge to the display location and until the start of the
fireworks display. From 12 p.m. on July 3, 2015 until 3 p.m. on July 4,
2015 the fireworks barge will be loaded off of Schneider Dock in
Eureka, CA in approximate position 40[deg]47'50'' N., 124[deg]11'11''
W. (NAD 83). From 3 p.m. to 4 p.m. on July 4, 2015 the loaded barge
will transit from Schneider Dock to the launch site off of Woodley
Island near Eureka, CA at approximate position 40[deg]48'29' N.,
124[deg]10'06'' W. (NAD 83) where it will remain until the commencement
of the fireworks display. Upon the commencement of the 25 minute
fireworks display, scheduled to begin at 10 p.m. on July 4, 2015, the
safety zone will increase in size to encompass the navigable waters
around and under the fireworks barge within a radius 1,000 feet at
approximate position 40[deg]48'29'' N., 124[deg]10'06'' W. (NAD 83) for
the Fourth of July Fireworks, City of Eureka in 33 CFR 165.1191, Table
1, Item number 3. This safety zone will be in effect from 12 p.m. on
July 3, 2015 until 10:40 p.m. on July 4, 2015.
    Under the provisions of 33 CFR 165.1191, unauthorized persons or
vessels are prohibited from entering into, transiting through, or
anchoring in the safety zone during all applicable effective dates and
times, unless authorized to do so by the PATCOM. Additionally, each
person who receives notice of a lawful order or direction issued by an
official patrol vessel shall obey the order or direction. The PATCOM is
empowered to forbid entry into and control the regulated area. The
PATCOM shall be designated by the Commander, Coast Guard Sector San
Francisco. The PATCOM may, upon request, allow the transit of
commercial vessels through regulated areas when it is safe to do so.
This notice is issued under authority of 33 CFR 165.1191 and 5 U.S.C.
552(a). In addition to this notice in the Federal Register, the Coast
Guard will provide the maritime community with extensive advance
notification of the safety zone and its enforcement period via the
Local Notice to Mariners.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.

    Dated: April 23, 2015.
Gregory G. Stump,
Captain, U.S. Coast Guard. Captain of the Port San Francisco.
[FR Doc. 2015-13133 Filed 5-29-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 186 (Tuesday, September 27, 2022)]
[Rules and Regulations]
[Pages 58445-58449]
[FR Doc No: 2022-20819]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2017-C-6238]

Listing of Color Additives Exempt From Certification; Calcium
Carbonate

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the
color additive regulations to provide for the safe use of calcium
carbonate in dietary supplement tablets and capsules. We are taking
this action in response to a color additive petition (CAP) submitted by
Colorcon, Inc. (Colorcon or petitioner).

DATES: This rule is effective October 28, 2022. Submit either
electronic or written objections and requests for a hearing on the
final rule by October 27, 2022. See section XI for further information
on the filing of objections. The incorporation of reference of certain
material listed in this rule is approved by the Director of the Federal
Register as of October 27, 2022.

ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. The https://www.regulations.gov electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of
October 27, 2022. Objections received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
received on or before that date.

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your objection will be
made public, you are solely responsible for ensuring that your
objection does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your objection, that information will be
posted on https://www.regulations.gov.
     If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Dockets
Management Staff, FDA will post your objection, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-C-6238 for ``Listing of Color Additives Exempt from
Certification; Calcium Carbonate.'' Received objections, those filed in
a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objections only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We
will review this copy, including the claimed confidential information,
in our consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20

and other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Christopher Kampmeyer, Office of Food
Additive Safety (HFS-255), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740-3835,<PHONE_NUMBER>; or Alexandra Jurewitz, Office of
Regulations and Policy (HFS-024), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notification published in the Federal Register on November 20,
2020 (85 FR 74304), we announced that we filed a color additive
petition (CAP 0C0318) submitted by Colorcon, Inc., 275 Ruth Rd.,
Harleysville, PA 19438. The petition proposed to amend the color
additive regulations in Sec.  73.70 ``Calcium Carbonate,'' by expanding
the permitted uses of calcium carbonate to include use in dietary
supplement tablets and capsules, including coatings and printing inks,
in amounts consistent with good manufacturing practice.

II. Background

    Calcium carbonate (CAS 471-34-1) is a fine, white powder prepared
either by grinding naturally occurring limestone or produced
synthetically through a precipitation process using heat, water, and
carbon dioxide. Calcium carbonate is slightly soluble in water and
dissociates into calcium and carbonate ions in an aqueous environment.
Calcium is abundant in the human body and is an integral component of
bones, teeth, and other biological structures. Carbonate is also
present in the human body, e.g., as a critical component of the pH
buffering system.
    Calcium carbonate is authorized under Sec.  73.70 for use as a
color additive in soft and hard candies, mints, and in inks used on the
surface of chewing gum, in amounts consistent with good manufacturing
practice, except that it may not be used to color chocolate or the
chocolate portion of candy, as the standards of identity for chocolate
do not provide for the use of color additives. Calcium carbonate is
also authorized under Sec.  73.1070 for use as a color additive in
drugs; generally, in amounts consistent with good manufacturing
practice. Additionally, food grade calcium carbonate and ground
limestone (consisting of not less than 94 percent calcium carbonate)
are affirmed as generally recognized as safe in 21 CFR 184.1191 and
184.1409, respectively. These two regulations do not include
limitations for use in food other than current good manufacturing
practice, which our regulations define at Sec.  184.1(b).
    The petitioner stated that calcium carbonate complies with the
specifications in the 10th edition of the Food Chemicals Codex (FCC
10), which was incorporated by reference into Sec.  73.70 (82 FR 51554,
November 7, 2017). Since this regulation became effective, the 13th
edition of the FCC (FCC 13) has published. The specifications for
calcium carbonate and ground limestone are the same in both FCC 10 and
FCC 13. Therefore, we are updating our incorporation by reference to
FCC 13. In an email dated May 26, 2022, the petitioner concurred with
updating the FCC reference from FCC 10 to FCC 13.
    The petitioner concluded that the amount of calcium carbonate
petitioned for use in dietary supplement tablets and capsules is self-
limiting because the addition of the color additive above a certain
level would be uneconomical and/or have adverse consequences on the
quality of the dietary supplements. Because the petitioner concluded
that the amount of calcium carbonate used as a color additive in
dietary supplement tablets and capsules would be self-limiting, they
did not propose any tolerances or other limitations. We determined
there is no need for a specific upper limit for this use of calcium
carbonate (Ref. 1).

III. Safety Evaluation

    Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive may not be listed
for a particular use unless the data and information available to FDA
establish that the color additive is safe for that use. Our color
additive regulations at 21 CFR 70.3(i) define ``safe'' to mean that
there is convincing evidence establishing with reasonable certainty
that no harm will result from the intended use of the color additive.
    To establish with reasonable certainty that a color additive
intended for use in foods is not harmful under its intended conditions
of use, we consider the projected human dietary exposure to the color
additive; the additive's toxicological data; and other relevant
information (such as published literature) available to us. We compare
the estimated dietary exposure, or estimated daily intake (EDI), of the
color additive from all dietary sources to an acceptable daily intake
(ADI) level established by toxicological data. The EDI is determined by
projections based on the amount of the color additive proposed for use
in particular foods and on data regarding the amount consumed from all
sources of the color additive. We commonly use the EDI for the 90th
percentile consumer of a color additive as a measure of high chronic
exposure.

IV. Safety of the Petitioned Use of the Color Additive

A. Dietary Exposure Estimate

    The petitioner estimates that the amount of calcium carbonate as a
color additive in dietary supplements would not exceed 24 milligrams
(mg) per dietary supplement (Ref. 2). The petitioner used data for
dietary supplements from the 2011-2014 National Health and Nutrition
Examination Survey (NHANES) to estimate dietary exposure to calcium
carbonate and elemental calcium from the proposed use. From the NHANES
data, the petitioner determined that the U.S. population aged 2 years
and older consumes two dietary supplements in a 24-hour period at the
mean and five at the 90th percentile. We note that these values could
represent two or five of the same or different dietary supplements. In
estimating dietary exposure, the petitioner assumed that all dietary
supplements consumed would contain calcium carbonate as a color
additive and that each dietary supplement consumed contains 24 mg
calcium carbonate. This results in a dietary exposure estimate to
calcium carbonate of 48 milligrams/person/day (mg/p/d) at the mean and
120 mg/p/d at the 90th percentile. Because calcium carbonate is
comprised of 40 percent calcium, the petitioner noted that the maximum
dietary exposure to calcium from this use of calcium carbonate is
estimated to be 19 mg/p/d at the mean and 48 mg/p/d at the 90th
percentile.
    The petitioner stated that the maximum amount of calcium carbonate
deposited as a printing ink on the surface of the dietary supplement
would

be 0.009 mg, which corresponds to approximately 0.004 mg of calcium per
dietary supplement. The petitioner concluded that the contribution to
the dietary exposure from use in printing ink on the surface of dietary
supplements is accounted for in the dietary exposure estimate for the
use of calcium carbonate as a color additive at the maximum proposed
use level in dietary supplements. FDA concurred with this approach
regarding the dietary exposure estimate for calcium and calcium
carbonate from the petitioned uses of calcium carbonate (Ref. 2).
    FDA previously determined the cumulative estimated dietary intake
(CEDI) for calcium from all sources to be 1,150 mg/p/d at the mean and
1,925 mg/p/d at the 90th percentile for the U.S. population aged 2
years and older (Ref. 3). The petitioner summed FDA's mean cumulative
dietary exposure to calcium (1,150 mg/p/d) (Ref. 3) with the mean
dietary exposure to calcium from the petitioned uses (19 mg/p/d) (Ref.
2) to estimate a revised mean CEDI for elemental calcium from the
existing uses as well as the petitioned use of calcium carbonate as a
color additive in dietary supplement tablets and capsules, including
coatings and printing inks. This resulted in a mean CEDI for calcium of
1,169 mg/p/d for the U.S. population aged 2 years and older. Using an
analogous approach, the 90th percentile CEDI for calcium, determined
previously (1,925 mg/p/d; Ref. 3), was summed with the 90th percentile
value (48 mg/p/d) from the petitioned uses to derive an upper bound
90th percentile CEDI for calcium of <2,000 mg/p/d for the U.S.
population aged 2 years and older (Ref. 2).

B. Toxicological Considerations

    To support the safety of the petitioned use of calcium carbonate,
the petitioner noted that calcium carbonate and ground limestone are
affirmed as generally recognized as safe under Sec. Sec.  184.1191 and
184.1409, respectively. The petition referenced FDA's safety review of
calcium carbonate in CAP 6C0307 (Ref. 4), which resulted in FDA's
listing of calcium carbonate in Sec.  73.70. Calcium carbonate can
dissociate into calcium and carbonate ions in aqueous environments,
making those two ions relevant to a safety evaluation of ingested
calcium carbonate. Based on carbonate's chemical structure and
physiological functions, no further safety analysis of carbonate
exposure was necessary (Ref. 4). FDA also considered safety evaluations
by the Institute of Medicine (IOM) and safety information resulting
from a search of the published literature (Ref. 4). In the IOM's 2011
report on dietary reference intakes for calcium and vitamin D, the IOM
updated recommended tolerable upper limits (ULs) for calcium ranging
from 2,000 to 3,000 mg/p/d for the U.S. population aged 1 year and
older, based on a comprehensive literature review (Ref. 5). The IOM
considered the UL as the highest average daily exposure that is likely
to pose no risk of adverse effects to almost all individuals in the
general population (Ref. 5).
    We conducted a search of the literature from January 2016 until
December 2021 to identify publications germane to our safety evaluation
using several different databases (i.e., PubMed, Web of Science and
ToxNet). We reviewed the articles found in this search and other
relevant studies available to FDA on the safety of calcium and calcium
carbonate (Ref. 6). We also noted that in our previous safety review
(Ref. 4) we determined that no further safety analysis of carbonate was
necessary, based on its chemical structure and physiological functions
(Ref. 6).
    Based on our review, we considered the UL established by IOM for
calcium (2,000 mg/p/d) to remain an appropriate benchmark for assessing
the safety of dietary exposure to calcium from the petitioned use of
calcium carbonate (Ref. 6). For the U.S. population aged 2 years and
older, the dietary exposure estimate at the 90th percentile is below
the IOM's UL of 2,000 mg/p/d. Additionally, the body of literature on
calcium carbonate and calcium does not present evidence of safety
concerns at the expected dietary exposure (Ref. 6). Based on our review
of the recently published literature, and because the 90th percentile
dietary exposure to calcium from all dietary sources, including the
petitioned uses of calcium carbonate, is less than the UL determined by
IOM, the dietary exposure to calcium from the proposed use of calcium
carbonate as a color additive in dietary supplement tablets and
capsules, including coatings and printing inks, does not raise safety
concerns (Ref. 6). Therefore, we conclude that there is a reasonable
certainty of no harm from this proposed use as a color additive.

V. Incorporation by Reference

    FDA is incorporating by reference the monographs for calcium
carbonate and limestone, ground from the Food Chemicals Codex, 13th
ed., 2022, which was approved by the Office of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may purchase a
copy of the material from the United States Pharmacopeial Convention,
12601 Twinbrook Pkwy., Rockville, MD 20852, 1-800-227-8772, https://www.usp.org. You may inspect a copy at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852,<PHONE_NUMBER>, between 9 a.m. and 4 p.m., Monday
through Friday. Because materials incorporated by reference will no
longer be available at FDA's main library, we are revising Sec.  73.70
to update the location where referenced materials cited in FDA
regulations can be found; the new location will be at the Dockets
Management Staff.
    The FCC monographs establish a standard for purity and identity for
calcium carbonate. The monographs provide specifications and analytical
methodologies used to identify the substance and establish acceptable
purity criteria. The current color additive regulation for the use of
calcium carbonate (Sec.  73.70) indicates that the additive must meet
the specifications in the FCC 10. The most current version of the FCC
is the FCC 13, and the specifications for calcium carbonate in FCC 13
are identical to those in FCC 10. Therefore, we are amending Sec.
73.70 by adopting, and incorporating by reference, the specifications
for calcium carbonate and ground limestone in FCC 13 in place of FCC
10.

VI. Conclusion

    Based on the data and information in the petition and other
available relevant information, we conclude that the petitioned use of
calcium carbonate for use as a color additive in dietary supplement
tablets and capsules, including coatings and printing inks, is safe. We
further conclude that the color additive will achieve its intended
technical effect and is suitable for the petitioned use. Therefore, we
are amending the color additive regulations in part 73 to provide for
the safe use of this color additive as set forth in this document. In
addition, based on the factors in 21 CFR 71.20(b), we conclude that
batch certification of calcium carbonate, proposed for use as a color
additive in dietary supplement tablets and capsules, including coatings
and printing inks, is not necessary for the protection of public health
(Ref. 1).

VII. Public Disclosure

    In accordance with Sec.  71.15, the petition and the documents that
we considered and relied upon in reaching our decision to approve the
petition will be made available for public disclosure

(see FOR FURTHER INFORMATION CONTACT). As provided in Sec.  71.15, we
will delete from the documents any materials that are not available for
public disclosure.

VIII. Analysis of Environmental Impact

    As stated in the November 20, 2020, Federal Register notification
of filing, the petitioner claimed that this action is categorically
excluded under Sec.  25.32(k) because the substance is intended to
remain in food through ingestion by consumers and is not intended to
replace macronutrients in food. We further stated that if FDA
determines a categorical exclusion applies, neither an environmental
assessment nor an environmental impact statement is required. We did
not receive any new information or comments regarding this claim of
categorical exclusion. We considered the petitioner's claim of
categorical exclusion and determined that this action is categorically
excluded under Sec.  25.32(k). Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

X. Section 301(ll) of the FD&C Act

    Our review of this petition was limited to section 721 of the FD&C
Act. This final rule is not a statement regarding compliance with other
sections of the FD&C Act. For example, section 301(ll) of the FD&C Act
(21 U.S.C. 331(ll)) prohibits the introduction or delivery for
introduction into interstate commerce of any food that contains a drug
approved under section 505 of the FD&C Act (21 U.S.C. 355), a
biological product licensed under section 351 of the Public Health
Service Act (42 U.S.C. 262), or a drug or biological product for which
substantial clinical investigations have been instituted and their
existence has been made public, unless one of the exemptions in section
301(ll)(1) to (4) of the FD&C Act applies. In our review of this
petition, we did not consider whether section 301(ll) of the FD&C Act
or any of its exemptions apply to food containing this color additive.
Accordingly, this final rule should not be construed to be a statement
that a food containing this color additive, if introduced or delivered
for introduction into interstate commerce, would not violate section
301(ll) of the FD&C Act. Furthermore, this language is included in all
color additive final rules that pertain to food and therefore should
not be construed to be a statement of the likelihood that section
301(ll) of the FD&C Act applies.

XI. Objections

    This rule is effective as shown in the DATES section, except as to
any provisions that may be stayed by the filing of proper objections.
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Dockets Management Staff (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) to which you object, and
the grounds for your objection. Within each numbered objection, you
must specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a hearing on that objection. If you request a hearing,
your objection must include a detailed description and analysis of the
specific factual information you intend to present in support of the
objection in the event that a hearing is held. If you do not include
such a description and analysis for any particular objection, you waive
the right to a hearing on the objection.
    Any objections received in response to the regulation may be seen
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we
have received or lack thereof in the Federal Register.

XII. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

* 1. Memorandum from N. Hepp, Color Technology Branch, Office of
Cosmetics and Colors, Center for Food Safety and Applied Nutrition
(CFSAN), FDA to C. Kampmeyer, Division of Food Ingredients (DFI),
Office of Food Additive Safety (OFAS), CFSAN, FDA, May 11, 2022.
* 2. Memorandum from D. Doell, Chemistry Review Team, DFI, OFAS,
CFSAN, FDA to C. Kampmeyer, DFI, OFAS, CFSAN, FDA, May 11, 2022.
* 3. Memorandum from D. Doell, Division of Petition Review (DPR),
OFAS, CFSAN, FDA to J. Kidwell, DPR, OFAS, CFSAN, FDA, February 16,
2017.
* 4. Memorandum from T.S. Thurmond, DPR, OFAS, CFSAN, FDA to J.
Kidwell, DPR, OFAS, CFSAN, FDA, February 17, 2017.
5. Committee to Review Dietary Reference Intakes for Vitamin D and
Calcium, Food and Nutrition Board, Institute of Medicine, ``Dietary
Reference Intakes for Calcium and Vitamin D,'' National Academies
Press, Washington, DC 2011. Available at https://www.nap.edu/read/13050/chapter/1 (accessed July 27, 2021).
* 6. Memorandum from R. Chanderbhan, Toxicology Review Team, DFI,
OFAS, CFSAN, FDA to C. Kampmeyer, DFI, OFAS, CFSAN, FDA, May 11,
2022.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Incorporation by
reference, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for part 73 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.

0
2. Amend Sec.  73.70 by revising paragraphs (b) and (c) and adding
paragraph (f) to read as follows:

Sec.  73.70   Calcium carbonate.

* * * * *
    (b) Specifications. Calcium carbonate must meet the specifications
given in calcium carbonate (FCC 13) and limestone, ground (FCC 13).
    (c) Uses and restrictions. Calcium carbonate may be safely used in
amounts consistent with good manufacturing practice to color dietary
supplement tablets and capsules (including coatings and printing inks),
soft and hard candies and mints, and in inks used on the surface of
chewing gum, except that it may not be used to color chocolate for
which standards of identity have been promulgated under section 401 of
the Federal Food, Drug,

and Cosmetic Act unless added color is authorized by such standards.
* * * * *
    (f) Incorporation by reference. Material listed in this paragraph
(f) is incorporated by reference into this section with the approval of
the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR
part 51. All approved material is available for inspection at the Food
and Drug Administration and at the National Archives and Records
Administration (NARA). Contact the Food and Drug Administration between
9 a.m. and 4 p.m., Monday through Friday at: Dockets Management Staff,
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852,<PHONE_NUMBER>. For information on the availability
of this material at NARA, email: [email protected]; website:
www.archives.gov/federal-register/cfr/ibr-locations.html. You may
obtain the material from the U.S. Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852; website: www.usp.org.
    (1) Limestone, Ground, Food Chemicals Codex, 13th edition,
effective June 1, 2022 (FCC 13).
    (2) Calcium Carbonate, Food Chemicals Codex, 13th edition,
effective June 1, 2022 (FCC 13).

    Dated: September 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20819 Filed 9-26-22; 8:45 am]
BILLING CODE 4164-01-P