UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF PREVENTION, PESTICIDE

                   AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  05/March/2009

SUBJECT:	Pyrimethanil; Section 3 Registration Request to Register New
Postharvest Uses on Stone Fruit, Crop Group 12 and a Preharvest Use on
Lemon.  Summary of Analytical Chemistry and Residue Data.

PC Code:  288201	DP Barcode:  D361301

Decision No.:  393117	Registration No.:  43813-32 and 264-788

Petition No.:  8E7353	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  None	Case No.:  None

TXR No.: None	CAS No.:  53112-28-0

MRID No.:  47425601 through 47425605	40 CFR:180.518

FROM:	  SEQ CHAPTER \h \r 1 Debra Rate, Ph.D., Biologist  SEQ CHAPTER \h
\r 1

		Alternative Risk Integration and Assessment (ARIA)

		Risk Integration, Minor Use, and Emergency Response Branch (RIMUERB)

		Registration Division (RD; 7505P)

THROUGH:	William Cutchin, Acting Senior Branch Scientist

		ARIA/RIUMERB/RD (7505P)

		George F. Kramer, Ph.D., Senior Chemist

		Risk Assessment Branch 1 (RAB1)

Health Effects Division (HED; 7509P)

TO:		Susan Stanton, Environmental Specialist  SEQ CHAPTER \h \r 1   SEQ
CHAPTER \h \r 1

		Minor Use Team

		RIUMERB/RD (7505P)

I.	 CONCLUSIONS

Regulatory Recommendations

Provided that a revised Section B, label (see requirements under
Directions for Use) and Section F (see requirements under Proposed
Tolerances) are submitted in addition to the submission of analytical
reference standards to replace expired samples; there are no residue
chemistry issues that would preclude granting a registration for uses of
pyrimethanil (Penbotec® 400SC (EPA Reg. No. 43813-32-2792) and Scala SC
(EPA Reg. No. 264-788)) on stone fruit and citrus fruit.  ARIA
recommends for the following permanent tolerances:

Fruits, stone, group 12	10 ppm

Fruit, citrus, group 10	11 ppm

ARIA recommends for the removal of the following tolerances
concomitantly with the establishment of the above tolerances:

Fruit, stone (except cherry), group 12	3.0 ppm

Fruit, citrus group 10 (postharvest)	10 ppm

Residue Chemistry Deficiencies

860.1200 Directions for Use

The label should be revised to prohibit the use of adjuvants with Scala
SC in the preharvest treatment of lemons.  The submitted label for
PENBOTEC 400SC states that stone fruit can be treated by high volume
spray, drench or dip; however, only stone fruit (except cherries) may be
treated with low-volume spray.  A revised Section B should be submitted
which accurately reflects the field trial data and label instructions
for both products.

860.1550 Proposed Tolerances

A summary of the recommended tolerances along with recommendations for
commodity definitions are presented in Table 9.  The petitioner should
submit a revised Section F to reflect these tolerance and commodity
definitions.

860.1650 Submittal of Analytical Reference Standards

The petitioner should submit new analytical standards for pyrimethanil,
to replace the expired samples.

II.	ACTION REQUESTED

Interregional Research Project No. 4 (IR-4) has submitted a request to
add a new preharvest use of pyrimethanil on lemons and postharvest uses
on stone fruit, crop group 12.  Pyrimethanil is used to control brown
rot and gray mold.  The end-use products (EPs) relevant to this
registration request are Penbotec® 400SC (EPA Reg. No. 43813-32) and
Scala SC (EPA Reg. No. 264-788) which are soluble concentrate (SC)
formulations containing 37.14% (equivalent to 3.27 lb ai/gal) and 54.6%
(equivalent to 5.0 lb ai/gal) active ingredient (ai), respectively.  The
EPs are proposed for postharvest treatment of fruit at 400 g ai/100 gal
mix (dipping) or a high-volume application rate of 400 g ai/200,000 lb
fruit, or preharvest application of mature fruit at a rate of
approximately 0.70 lb ai/A, respectively.  The proposed preharvest
interval (PHI) is 7 days for lemons.

Concurrently, IR-4 has proposed for the establishment of permanent
tolerances for residues of the fungicide pyrimethanil,
4,6-dimethyl-N-phenyl-2-pyrimidinamine, in/on the raw agricultural
commodities:

Fruit, stone, group 12	10 ppm

Fruit, citrus (except lemon), group 10 (postharvest)	10 ppm

Lemon	11 ppm

Upon approval of the aforementioned tolerances, IR-4 requests the
removal of the following established tolerances of the fungicide
pyrimethanil, 4,6-dimethyl-N-phenyl-2-pyrimidinamine, in/on the raw
agricultural commodities:

Fruit, stone (except cherry), group 12	3.0 ppm

Fruit, citrus group 10 (postharvest)	10 ppm

III.	Executive Summary

Pyrimethanil [4,6-dimethyl-N-phenyl-2-pyrimidinamine] is an amino acid
synthesis inhibitor that inhibits the secretion of fungal enzymes
necessary for fungal infection.  Pyrimethanil is currently registered in
the U.S. for use on almonds, pome fruit, citrus fruit, stone fruit
(except cherry), bananas, grapes, onions, pistachios, strawberries,
tomatoes and tuberous and corm vegetables.  Pyrimethanil is applied to
the above crops as 1-6 broadcast applications (foliar or mature fruit)
per year not to exceed the maximum seasonal rate (0.7 - 2.1 lb ai/A),
depending on the crop.  Minimum preharvest intervals (PHIs) range from 0
to 7 days.

Permanent tolerances have been established for residues of pyrimethanil
per se in/on plant commodities at levels ranging from 0.05 ppm in/on
vegetable, tuberous and corm, subgroup 1C to 150 ppm in/on citrus oil
[40 CFR §180.518(a)(1)].  Tolerances have also been established for
pyrimethanil residues and its metabolite
4-[4,6-dimethyl-2-pyrimidinyl)amino]phenol in fat (0.01 ppm), kidney
(2.5 ppm) and byproducts (except kidney) (0.01 ppm) of cattle, goats,
horses and sheep and in milk (0.05 ppm) [40 CFR §180.518(a)(2)].

  SEQ CHAPTER \h \r 1 The qualitative nature of the pyrimethanil residue
in plant commodities is adequately understood based on acceptable
metabolism studies in lettuce, grapes, and tomatoes.  The HED Metabolism
Assessment Review Committee (MARC) has determined that for risk
assessment and tolerance expression that the parent is the only residue
of concern.  Future new uses on root crops whose tops are significant
food/feed items will require the analysis of metabolite AEC614278.

The crop uses proposed in this petition include dried citrus pulp (i.e.
proposed preharvest use on lemons) which is a regulated livestock
feedstuff; however, citrus pulp was addressed in a previous Agency
memorandum (DP# 284001, J. Morales and G. Kramer, 12/JAN/2004) and the
addition of this lemon use will not change previously calculated
livestock tolerances.  Therefore, issues pertaining to livestock
metabolism, analytical methods and storage stability data for and
residues in livestock commodities are not addressed in the current
petition.

A high-performance liquid chromatography (HPLC) residue analytical
method entitled, “Analytical Method for the Determination of Residues
of ZK 100309 in Vines, Strawberries, and Apples by HPLC” was submitted
in conjunction with an earlier pyrimethanil petition, PP#4E4384, for the
establishment of a tolerance on imported wine grapes.  The method has
been subjected to a successful independent laboratory validation (ILV)
and was subsequently forwarded to Analytical Chemistry Branch
(ACB)/Biological and Economics Analysis Division (BEAD) for a successful
petition method validation (PMV).

The data collection method used to generate residue data in conjunction
with magnitude of the residue studies associated with this petition is a
gas chromatography with mass selective detection (GC/MSD).  The limit of
quantitation (LOQ) ranged from 0.01-0.062 ppm; the calculated limit of
detection (LOD), ranged from 0.001 ppm to 0.021 ppm.  The adequacy of
the GC/MSD method for data collection was verified in each matrix by
fortifying control samples with pyrimethanil at tolerance-setting
levels.  Method recoveries were within the acceptable range of 70-120%
for all fortified samples.

Adequate field trial data, reflecting the proposed use pattern according
to the label directions, were submitted for lemons.  Maximum residues
following preharvest treatment at 0.690-0.817 lb ai/A (1.0x) and PHIs of
7 days were 0.27 ppm in/on lemons.  Maximum residues following
postharvest treatment by combinations of an aqueous drench (500 or 1000
ppm), storage wax line spray (2000 ppm), pack out wax line spray (2000
ppm), and an aqueous dip (1000 ppm) or line sprayer (2000 ppm) were 6.35
ppm in/on lemons.  The available data suggest that the recommended
tolerance of 11 ppm in/on citrus fruit for all of the labeled and
proposed uses (preharvest and postharvest) will not be exceeded when
maximum residues from all routes of pyrimethanil exposure are considered
(1 ppm for preharvest (lemon only) + 10 ppm for postharvest by line
spray aqueous and wax + postharvest by dipping).

Adequate postharvest data were submitted for the representative crops of
fruit, stone, group 12 (tart cherries, sweet cherries, peaches, and
plums).  These data indicate that following one postharvest treatment
via dipping or spraying of stone fruits using an SC formulation at 0.882
lb ai/200,000 fruit (2.0x the proposed rate; except for tart cherries
(0.65x and 0.86x)), maximum residues of pyrimethanil were 1.39 ppm in/on
tart cherries, 13.0 ppm in/on sweet cherries, 8.2 ppm in/on peaches and
2.0 ppm in/on plums.  The available data suggest that the proposed crop
group tolerance of 10 ppm for stone fruits will be not be exceeded when
maximum residues from all routes of pyrimethanil exposure at the
labeled/proposed use rate to stone fruits are considered (preharvest +
postharvest by line spray aqueous and wax + postharvest by dipping).

No processed food and feed studies were necessary or submitted for the
proposed uses and requested tolerances of the current petition.
Processing studies for citrus fruit and plum were previously reviewed
(DP# 284001 & 284870, J. Morales, 12/JAN/2004) and while pyrimethanil
residues were found not to concentrate in prunes, following an
exaggerated (5x) study, pyrimethanil residues concentrated 16x in citrus
oil.

Stone fruits and lemons are typically not rotated.  Therefore, residue
data pertaining to confined and field accumulation in rotational crops
are not germane to this tolerance petition.

DETAILED CONSIDERATIONS

Background

  SEQ CHAPTER \h \r 1 Pyrimethanil is an anilinopyrimidine fungicide
that inhibits the secretion of fungal enzymes which are required during
the infection process.  Pyrimethanil blocks the ability of the fungus to
degrade and digest the plant tissues, thus stopping penetration and
development of the disease.  The precise mechanism of inhibition of
enzyme secretion has not been fully established.  Protein synthesis is
not inhibited, and evidence suggests that extracellular enzymes
accumulate inside the fungus, their release being blocked in the
presence of the fungicide.  Pyrimethanil penetrates rapidly into the
plant tissues, where it stops the development of the disease, providing
a significant curative action.  In vitro, germ tube extension and
mycelial growth are inhibited.

Pyrimethanil does not exhibit cross-resistance to sterol-inhibitors,
dicarboximides, benzimidazoles, quinone outside inhibitors, or
phenylamides, but may exhibit cross-resistance in certain plant
pathogenic fungi including anilinopyridine (AP) compounds such as
cyprodinil and mepanipyrim.  The nomenclature of pyrimethanil is
summarized in Table 1.  The physicochemical properties of pyrimethanil
are summarized in Table 2.

Table 1.  Test Compound Nomenclature

Chemical structure

Common name	Pyrimethanil

Company experimental name	NR*

IUPAC name	N-(4,6-dimethylpyrimidin-2yl)aniline

CAS name	4,6-dimethyl-N-phenyl-2-pyrimidinamine

CAS #	53112-28-0

End-use product/(EP)	Penbotec® 400SC and Scala SC

*NR = Not Reported

Table 2.  Physicochemical Properties of the Technical Grade Test
Compound

Parameter	Value	References

Melting point/range	96oC	The Pest Manual.  British Crop Protection
Council.  Twelfth Edition, Editor: C.D.S. Tomlin.

pH (water solution at 25oC)	6.1

	Specific gravity at 20oC	1.15

	Water solubility (g/l at 25oC)	0.121

	Solvent solubility (g/l at 20oC)	 acetone – 389, ethyl acetate –
617, methanol – 176, methylene chloride – 1000, n-hexane – 23.7,
toluene – 412

	Vapour pressure at 25oC	2.2 mPa

	Octanol/water partition coefficient log (KOW)  	2.84

	UV/visible absorption spectrum	No UV absorption above 290 nm	Pest
Management Regulatory Agency Health, Canada, 2006.

860.1200 Directions for Use

Table 3.  Summary of Section B Directions for Use of Pyrimethanil.

Applic. Timing, Type, and Equip.	Formulation

[EPA Reg. No.]	Applic. Rate	Max. No. Applic. per Season	Max. Seasonal
Applic. Rate	PHI

(days)	Use Directions and Limitations

Stone Fruit, Crop Group 12

High-Volume Spray, Drench or Dip

	PENBOTEC 400SC

[43813-32]

	16 fl.oz/100 gal water with water or wax/oil emulsion to treat 200,000
lbs. fruit	1

	16 fl.oz/100 gal water/200,000 lbs. fruit

(0.0255 lb ai/oz)

	NA

	Do not make more than one postharvest application.  May be applied the
same day as sold or eaten.

Low-Volume Spray

	PENBOTEC 400SC

[43813-32]

	64 fl.oz/100 gal water with water or wax/oil emulsion.  Apply 10-25 gal
to treat 200,000 lbs. fruit	1

	64 fl.oz/100 gal water Apply 10-25 gal to 200,000 lbs. fruit

	NA

	Do not make more than one postharvest application.  May be applied the
same day as sold or eaten.  Do not use this method of application on
cherry.

Lemon

Foliar air blast

	SCALA SC

[264-788]

	18 fl oz/A (0.690 lb ai/A)

	1

	18 fl oz/A/season (0.690 lb ai/A/season)	7

	Do not apply with in 7 days of harvest (7-day PHI).  Do not apply more
than 18 fl oz /A/year in the field.

Text in bold-type is present on the label but is missing from the
Section B.

Conclusions  The submitted label for PENBOTEC 400SC states that stone
fruit can be treated by high volume spray, drench or dip; however, only
stone fruit (except cherries) may be treated with low-volume spray.  The
Section B should be revised and submitted to match the label for this
condition.

The submitted label for SCALA SC does not include use directions for
lemon.  No adjuvants were used in the lemon studies.  The label should
be revised to include the proposed use for lemons, and to prohibit the
use of adjuvants in the preharvest treatment of lemons.

860.1300 Nature of the Residue – Plants

DP#s 284001 & 284870, J. Morales and G. Kramer, 12/JAN/2004 (PP#s
2F06439 and 2F06480)

  SEQ CHAPTER \h \r 1 The qualitative nature of the pyrimethanil residue
in plant commodities is adequately understood based on acceptable
metabolism studies in lettuce, grapes, and tomatoes.  The HED Metabolism
Assessment Review Committee (MARC) has determined that for risk
assessment and tolerance expression, parent only is the residue of
concern.  Future new uses on root crops whose tops are significant
food/feed items will require the analysis of metabolite AEC614278.

860.1340 Residue Analytical Methods

DP# 284866, D. Vogel, et al, 11/15/2004.

Enforcement methods

A residue analytical method entitled “Analytical Method for the
Determination of Residues of ZK 100309 in Vines, Strawberries, and
Apples by HPLC” was submitted in conjunction with an earlier
pyrimethanil petition, PP#4E4384, for the establishment of a tolerance
on imported wine grapes.  The method has been subjected to a successful
PMV by ACB/BEAD (DP# 288256, E. Kolbe, 7/JUL/2004).

Data-collection method(s)

The data-collection method used to generate residue data in conjunction
with magnitude of the residue studies associated with this petition is a
GC/MSD method derived from “Fruit and Vegetables: Analytical Method
for the Determination of Residues (Improved Version), Pyrimethanil,
Active Substance.”  Briefly, pyrimethanil residues were extracted by
homogenization with acetone.  An aliquot of the extract was acidified
then washed with hexane before adding base to enable solvent partition.
Final clean-up was by silica solid phase extraction (SPE), with
determination by GC/MSD.  The lowest level of method validation (LLMV)
was 0.05 ppm, the LOD and LOQ were calculated to range from 0.001 ppm to
0.021 ppm and 0.01-0.062 ppm, respectively.  The adequacy of the GC/MSD
method for data collection was concurrently verified by fortifying
control samples of each matrix with pyrimethanil at tolerance-setting
levels.  Method recoveries were within the acceptable range of 70-120%
for all fortified samples.

860.1360 Multiresidue Methods

DP# 284001 and 284870, J. Morales and G. Kramer, 12/JAN/2004 (PP#s
2F06439 and 2F06480)

  SEQ CHAPTER \h \r 1 Pyrimethanil was tested through Protocols C, D,
and E of the standard Food and Drug Administration (FDA) Multiresidue
Protocols.  Pyrimethanil was found to be nondetectable by the
electron-capture (EC) detector.  The use of a nitrogen-specific detector
is recommended.  Recovery was complete (>100%) using the Luke procedure
for grapes (non-fatty food) fortified at 0.05 and 5.0 ppm.  No recovery
was obtained from cottonseed oil (fatty food) fortified at 0.05 ppm.
For cottonseed oil fortified at 0.5 ppm, average recoveries of 28%
(range 16-40%) and 78% (range 75-82%) were obtained when using the ether
and the methylene chloride system, respectively.  Pyrimethanil eluted
from the standardized Florisil column.  Recovery ranged from 86 to 98%
using two different systems.

860.1380 Storage Stability

47425601.der.doc, D. Rate, 03/NOV/2008. (Peach)

47425602.der.doc, D. Rate, 03/NOV/2008. (Plum)

47425603.der.doc, D. Rate, 03/NOV/2008. (Sweet Cherry)

47425604.der.doc, D. Rate, 03/NOV/2008. (Lemon)

47425605.der.doc, D. Rate, 03/NOV/2008. (Cherry)

Fruit samples that were collected from the pre- and postharvest residue
studies associated with this petition were stored frozen prior to
residue analysis for durations of 0 days to 523 days.  No additional
supporting storage stability data were included in the review package.
However, it has been previously reported that residues of pyrimethanil
are reasonably stable under frozen storage conditions in/on apples for
up to 676 days (DP# 347247 and 347248, G. Kramer, 17/JUL/2008).

860.1480 Meat, Milk, Poultry, and Eggs

The crop uses proposed in this petition include dried citrus pulp (i.e.
proposed preharvest use on lemons) which is a regulated livestock
feedstuff; however, citrus pulp was addressed in a previous Agency
memorandum (DP# 284001, J. Morales and G. Kramer, 12/JAN/2004) and the
addition of this lemon use will not change previously calculated
livestock tolerances.  Therefore, issues pertaining to livestock
metabolism, analytical methods and storage stability data for and
residues in livestock commodities are not addressed in the current
petition.

860.1500 Crop Field Trials

Lemon

47425604.der.doc, D. Rate, 03/NOV/2008. (Lemon)

Table 4.  Summary of Residue Data from Crop Field Trials with
Pyrimethanil.

Commodity	Total Applic. Rate

 (lb ai/A)	PHI

(days)	Sample size (n)	Residue Levels (ppm)

Min.	Max.	HAFT*	Median	Mean	Std. Dev.

Lemon	0.690 – 0.817	7	10	0.068	0.31	0.27	0.22	0.20	0.080

*HAFT = Highest Average Field Trial

IR-4 submitted field trial data to support the establishment of a
tolerance for residue of pyrimethanil in or on lemon.  Five field trials
were conducted for this study during the 2004 – 2005 growing season in
CA (Region 10).  At each trial, one foliar air blast application of
Scala( SC (54.6 % pyrimethanil) with no adjuvants or additives was made
at a rate of approximately 0.70 lb ai/A.  Mature lemons were harvested 7
days after the application.

Residues of pyrimethanil were analyzed in the IR-4 Western Region
Laboratory, Davis, CA.  The procedure used for the analysis was derived
from the AgrEvo UK Limited method 140/01/012, “Fruit and Vegetables:
Analytical Method for the Determination of Residues (Improved Version),
Pyrimethanil, Active Substance.”  Pyrimethanil residues in lemon were
extracted by homogenization with acetone.  An aliquot of the extract was
acidified then washed with hexane before adding base to enable solvent
partition.  Final clean-up was by silica SPE, with determination by
GC/MSD.

Based on recoveries of samples fortified at the LLMV, 0.05 ppm, the LOD
and LOQ were calculated as 0.017 ppm and 0.052 ppm, respectively.  No
residue decline data was submitted.

Conclusions:  In combination with previously reviewed data and the
established tolerance of 10 ppm for postharvest treatment of citrus
fruit, ARIA recommends for a tolerance in/on fruit, citrus, group 10 at
11 ppm which will include the labeled preharvest and postharvest
applications of pyrimethanil to lemons and the postharvest applications
to the remainder of the citrus fruit group.  Concomitant with the
establishment of the recommended tolerance, ARIA recommends for the
removal of the current 10 ppm tolerance on fruit, citrus, group 10
postharvest.

Stone Fruit - Postharvest Studies

47425601.der.doc, D. Rate, 03/NOV/2008. (Peach)

47425602.der.doc, D. Rate, 03/NOV/2008. (Plum)

47425603.der.doc, D. Rate, 03/NOV/2008. (Sweet Cherry)

47425605.der.doc, D. Rate, 03/NOV/2008. (Cherry)

Peach:

Table 5.  Summary of Residue Data from Crop Field Trials with
Pyrimethanil.

Commodity	Analyte	Total Application Rate,

(lb ai/100 gal mix)	Total Application  Rate

(ml ai /200,000 lb fruit)	Residue Levels (ppm)

Sample size (n)	Min.	Max.	HAFT*	Median	Mean	Std. Dev.

Peach	Pyrimethanil	0.868 – 0.882

6	3.4	8.2	7.4	5.7	5.5	1.8

	0.882 – 0.917	4	0.97	2.1	2.0	1.4	1.5	0.57

	0.926 – 0.935	4	2.3	3.3	2.9	2.6	2.7	0.43

*HAFT = Highest Average Field Trial

  SEQ CHAPTER \h \r 1 IR-4 submitted data for postharvest use of
pyrimethanil on peach.  To support the establishment of a tolerance for
pyrimethanil, the submitted data were obtained from 2 trials conducted
in California (EPA Region 10) and 1 trial in New Jersey (EPA Region 2).
Postharvest trials were conducted to represent the main growing regions
and methods of application.

At each test location peaches were dipped for approximately 30 seconds
in the fungicide solution with concentration 0.882 lb ai/100 gal
(treatment 2; 2x the proposed application rate).  Two additional
treatments were examined at the two California trials where peaches were
sprayed with Penbotec 400SC at a rate of approximately 0.882 lb
ai/200,000 lb fruit in a high-volume spray (treatment 3) and in a low
volume spray (treatment 4).  A fruit wax adjuvant was added to the
applied mixtures in all treatments.  After treatment, the peaches were
allowed to dry and the pits were removed.

Pyrimethanil residues were extracted from homogenized samples and after
clean-up analyzed by GC/MSD.  The procedure was derived from the AgrEvo
UK Limited method, “Fruit and Vegetables: Analytical Method for the
Determination of Residues (Improved Version), Pyrimethanil, Active
Substance.”  The method is acceptable as a data-gathering method.

Plum:

Table 6.  Summary of Residue Data from Crop Field Trials with
Pyrimethanil.

Commodity	Total Applic. Rate

 (lb ai/100 gal)	PHI (days)	Residue Levels (ppm)

	Sample size (n)	Min.	Max.	HAFT*	Median	Mean	Std. Dev.

Plum	0.879 – 0.881	NA	6	0.612	2.00	1.90	0.908	1.146	0.597

	0.890	NA	2	0.200	0.204	0.202	0.202	0.202	–

	0.916	NA	2	0.295	0.347	0.321	0.321	0.321	–

*HAFT = Highest Average Field Trial

  SEQ CHAPTER \h \r 1 IR-4 submitted data for postharvest use of
pyrimethanil on plum.  To support the establishment of a tolerance for
pyrimethanil, the submitted data were obtained from 1 trial conducted in
California (EPA Region 10), 1 trial in Washington (EPA Region 11) and
one in Michigan (EPA Region 5) during the 2004 growing season.  The
number of field trials and geographic representation are not in
accordance with OPPTS Guideline 860.1500 as this is a postharvest study.
 Postharvest trials were conducted to represent the main growing regions
and methods of application.

At each trial, plums were dipped for approximately 30 seconds in the
fungicide solution with a concentration of approximately 0.881 lb ai/100
gal mix (treatment 2; 2x the proposed application rate).  Two additional
treatments were examined at the California trial where plums were
sprayed with Penbotec 400SC at rates of approximately 0.890 lb ai/
200,000 lb fruit in a high-volume spray (treatment 3) and 0.917 lb ai/
200,000 lb fruit and in a low-volume spray (treatment 4).  A fruit wax
adjuvant was added to the applied mixtures in all treatments.  After
treatment, the plums were allowed to dry and the pits were removed.

Pyrimethanil residues were extracted from homogenized samples and after
clean-up analyzed by GC/MSD.  The procedure was derived from the AgrEvo
UK Limited method, “Fruit and Vegetables: Analytical Method for the
Determination of Residues (Improved Version), Pyrimethanil, Active
Substance.”  The method is acceptable as a data-gathering method.

Tart Cherry:

Table 7.  Summary of Residue Data at 0 day after application from Crop
Field Trials with Pyrimethanil

Commodity	Total Applic. Rate

 (ppm)	Sample size (n)	Residue Levels (ppm)

	Min.	Max.	HAFT*	Median	Mean	Std. Dev.

Cherry	323	16	0.61	1.21	1.16	1.03	0.98	0.20

	430	16	0.93	1.39	1.25	1.22	1.19	0.14

*HAFT = Highest Average Field Trial

  SEQ CHAPTER \h \r 1 IR-4 submitted data to support the establishment
of a tolerance for pyrimethanil postharvest use on cherry.  The
submitted data were obtained from 4 trials with cherries from different
origins (Chile and Argentina) of South America.  Cherries were purchased
at the local German market.  The field portion of the study was
conducted by eurofins-GAB GmbH in Niefern-Öschelbronn, Germany.  The
analytical portion of the study was conducted by eurofins-GAB GmbH at
Pforzheim, Germany.

Control samples were taken before the application.  One postharvest
application of active ingredient LAG 2002 259 (synonym: Penbotec 400 SC)
was made using two different treatments with two different
concentrations: ~300 ppm and ~400 ppm (0.65x and 0.86x the proposed
rate, respectively).  The fruits were dipped once into the treatment
solution for 30 – 60 seconds (treatment 1) and for 45 seconds
(treatment 2).  After being dried at room temperature, fruit samples
were stored at different testing conditions: chilled (CS), ambient (AS)
or at a combination of chilled and ambient storage conditions (CAS).
Treated samples were taken at different storage time intervals.  After
stones were removed from the fruits, treated and untreated samples were
placed and stored in deep freezing conditions at ≤ –19o C until
analysis.

Residues were extracted with acetonitrile and were analyzed by HPLC with
tandem mass spectrometry (MS/MS) detection.  Method validation recovery
at fortification levels 0.01 ppm – 2.0 ppm was 93 ( 5 % with a LOQ of
0.01 ppm.  This method is adequate for data collection.

Sweet Cherry:

Table 8.  Summary of Residue Data from Crop Field Trials with
Pyrimethanil.

Commodity	Total Applic. Rate

 (g ai/ 100 gal)

[Dip]	Total Applic. Rate

 (g ai/ 25,000 lb fruit)

[High volume]	Sample size (n)	Residue Levels (ppm)

Min.	Max.	HAFT*	Median	Mean	Std. Dev.

Sweet Cherry	398.89 – 399.70

6	2.1	13.0	12.5	5.7	6.8	4.7

399.05 –  418.10	4	1.2	12.0	12.0	6.6	6.6	6.2

*HAFT = Highest Average Field Trial

  SEQ CHAPTER \h \r 1 IR-4 submitted data for postharvest use of
pyrimethanil on sweet cherry.  To support the establishment of a
tolerance for pyrimethanil in/on sweet cherry, the submitted data were
obtained from one trial conducted in California (EPA Region 10), one
trial in Washington (EPA Region 11) and one in Michigan (EPA Region 5)
during the 2006 growing season.  The number of field trials and
geographic representation are not in accordance with OPPTS Guideline
860.1500 as this is a postharvest study.  Postharvest trials were
conducted to represent the main growing regions and methods of
application.

At each trial, fruit was dipped for approximately 30 seconds in the
fungicide solution (Penbotec 400 SC) with a concentration of
approximately 400 g ai/100 gal mix (treatment 2; 2x the proposed
application rate).  Two additional treatments were examined at a
high-volume application rate of 400 g ai/25,000 lb fruit at the
California and Washington trials, where cherries were sprayed on a
packing line (treatment 3) and with a backpack sprayer (treatment 4),
respectively. A fruit wax was added to the applied mixtures in all
treatments.  After treatment, the fruit was allowed to dry and the stems
and pits were removed.

Pyrimethanil residues were extracted from homogenized samples, and
analyzed by GC/MSD after SPE clean-up.

Conclusions:  The petitioner requested a tolerance of 10 ppm on stone
fruit.  Preharvest uses currently have an established tolerance of 3 ppm
on stone fruit (except cherry).  The data submitted with this petition
are for the postharvest application to representative crops of peaches,
plums and cherries.  The field trial studies were performed at 2x the
proposed application rate for all commodities except the tart cherries
for which the two submitted studies were performed at 0.65x and 0.86x
the proposed use rate.  Due to the nature of the postharvest
applications, the Agency will allow on a case-by-case basis for the
residues to be normalized to the proposed 1x application rate.
Following a normalization process for all submitted data and
commodities, the highest postharvest application residues would likely
occur at a level of 6.5 ppm on sweet cherries.  The highest postharvest
application residues (6.5 ppm) + the established tolerance for
preharvest uses on stone fruit (except cherry) (3 ppm) are not expected
to exceed the requested tolerance of 10 ppm.

The submitted data in conjunction with previously reviewed data support
a tolerance of 10 ppm on the proposed/labeled pre- and postharvest uses
of stone fruit.  Thus, ARIA recommends for the following tolerances: 10
ppm in/on fruit, stone.  ARIA also recommends for the removal of the
current tolerance of 3.0 ppm on fruit, stone (except cherry)
(postharvest).

860.1520 Processed Food and Feed

Processing studies for plum and citrus fruit were previously reviewed
(DP# 284001 and 284870, J. Morales, 12/JAN/2004) and pyrimethanil
residues were found not to concentrate in prunes, following an
exaggerated (5x) study.  However, pyrimethanil residues did concentrate
(16x) in citrus oil.  No additional processed food and feed studies were
necessary or submitted for the proposed uses and requested tolerances of
the current petition.

  SEQ CHAPTER \h \r 1 860.1650 Submittal of Analytical Reference
Standards

Analytical standards for pyrimethanil, with an expiration date
01/SEP/2008, are currently available in the EPA National Pesticide
Standards Repository.  The petitioner should submit new analytical
standards for pyrimethanil, to replace the expired samples.

860.1850 and 1900 Confined and Field Accumulation in Rotational Crops

Stone fruits and lemons are typically not rotated.  Therefore, residue
data pertaining to confined and field accumulation in rotational crops
are not germane to this tolerance petition.

860.1550 Proposed Tolerances

The Agency has determined that the residue of concern for the purpose of
tolerance expression in plants is parent only.  The residues of concern
for tolerance expression in ruminant tissues are parent + Metabolite
AEC614276, and for milk are parent + Metabolite AEC614277; see Figure 1
(Attachment 1) for chemical names and structures of these regulated
compounds.  The tolerance expressions proposed by the petitioner in its
submission of Section F are consistent with the tolerance definitions
for pyrimethanil in 40 CFR §180.518.

A summary of the recommended tolerances for the commodities addressed in
the current petition is listed in Table 9.

The recommended tolerance of 10 ppm for stone fruits (crop group 12) is
adequate and is supported by the submitted residue data.  When the
maximum residues from all routes of pyrimethanil exposure to stone
fruits (crop group 12) are considered (i.e., postharvest by high-volume
spray, drench or dip, or low-volume spray + preharvest application), the
total residues (ppm) are expected to be below the recommended tolerance.

The proposed tolerance of 10 ppm for citrus fruits (crop group 10)
(except lemon) is adequate and is supported by previously reviewed
residue data reflecting the proposed use pattern (DP#   SEQ CHAPTER \h
\r 1 284001 and 284870,   SEQ CHAPTER \h \r 1 J. Morales and   SEQ
CHAPTER \h \r 1 G. Kramer,   SEQ CHAPTER \h \r 1 12/JAN/2004).  However,
when the maximum residues from all routes of pyrimethanil exposure to
citrus fruits (crop group 10), are considered (i.e., postharvest by line
spray aqueous and wax + postharvest by dip or drench + preharvest use on
lemons), the expected total residues (ppm) will exceed the proposed
tolerance.  Thus, ARIA recommends for a tolerance of 11 ppm for all
labeled uses of pyrimethanil on fruit, citrus (crop group 10).

Codex maximum residue limits (MRLs) have been established for
pyrimethanil per se in/on plant commodities.  Codex MRLs are listed for
citrus fruit at 7 ppm (postharvest); cherry (postharvest), peach and
nectarine at 4 ppm; apricot at 3 ppm; and plum at 2 ppm.  Presumably due
to differences in application and use patterns, harmonization is not
feasible at this time.

A Canadian MRL for citrus fruit (Calamondins, citrus citron, citrus
hybrids, grapefruits, kumquats, lemons, limes, oranges, pummelos,
satsuma mandarins, tangerines) is established at 10 ppm and for stone
fruit (apricots,  nectarines, peaches, plumcots, plums, prune plums)
established at 3 ppm.  There are no Mexican MRLs established for
residues of pyrimethanil in commodities associated with this review.

An International Residue Limit (IRL) form is appended to this Summary
Document and follows this section.

Table 9.  Tolerance Summary for Pyrimethanil.

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

40 CFR §180.518 (a)(1)

Stone Fruits (Crop Group 12) 	10	10	Fruit, stone, group 12

Citrus Fruits (Crop Group 10) 	10	11	Fruit, citrus, group 10

	Fruit, stone (except cherry), group 12	3.0	Remove

	Fruit, citrus, group 10 (postharvest)	10	Remove

References

DP#:	NA

Subject:	Magnitude of the Residue Studies

From:	S. Usachenko

To:	D. Rate

Dated:	03/NOV/2008

MRIDs:	47425601, 47425602, 47425603, 47425604, 47425605

DP#:		284866

Subject:	  SEQ CHAPTER \h \r 1 PP#s: 2F6480, 9E6054, 2F6439.
Pyrimethanil in/on Tree Nuts, Bulb Vegetables, Grapes, Stone Fruit
(except Cherry), Pome Fruit, Citrus Fruit, Tuberous and Corm Vegetables,
Strawberry, Tomato, and Imported Banana.  Health Effects Division (HED)
Risk Assessment.  PC Code: 288201.

From:	D. Vogel and Y. Yang

To:	S. Gardner and M. Waller

Dated:	15/NOV/2004

MRIDs:	  SEQ CHAPTER \h \r 1 NA

DP#:	  SEQ CHAPTER \h \r 1 284001 and 284870

Subject:	  SEQ CHAPTER \h \r 1 PP#s 2F06439 & 2F06480.  Pyrimethanil on
Tree Nuts, Stone Fruit, Bulb

Vegetables, Grapes, Pome Fruit, Tuber & Corm Vegetables, Strawberries,

and Tomatoes.  Summary of Analytical Chemistry and Residue Data.

From:		J. Morales and G. Kramer

To:		D. Vogel and M. Waller

Dated:		12/JAN/2004

MRIDs:	Various

  SEQ CHAPTER \h \r 1 Attachment:

International Residue Limit Status sheet

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:

4,6-Dimethyl-N-phenyl-2-pyrimidinamine	Common Name:

Pyrimethanil

	√ Proposed/Recommended Tolerance

( Reevaluated tolerance

( Other	Date:  01/13/2008

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

( No Codex proposal step 6 or above

( No Codex proposal step 6 or above for the crops requested	Petition
Number:  PP#  8E7353

DP#:  361301

Other Identifier:

Residue definition (step 8/CXL): pyrimethanil for plant commodities.
For compliance with MRLs and estimation of dietary intake for plant
commodities: pyrimethanil

For compliance with MRLs for milk: the sum of pyrimethanil and
2-anilino-4,6-dimethylpyrimidin-5-ol, expressed as pyrimethanil, and for
livestock tissues (excluding poultry) is the sum of pyrimethanil and
2-(4-hydroxyanilino)-4,6-dimethylpyrimidine, expressed as pyrimethanil.

	Reviewer/Branch:  D. Rate/ARIA/RIMUERB

	Residue definition:

Plants  - Parent only

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

Citrus fruit (post harvest)	7	Citrus Fruit (Crop Group 10), 	11

Cherry (post harvest)	4	Stone Fruit (Crop Group 12) 	10

Apricot	3

Peach	4

Nectarine	4

Plum	2

Limits for Canada	Limits for Mexico

( No Limits

( No Limits for the crops requested	( No Limits

 √ No Limits for the crops requested

Residue definition:

4,6-dimethyl-N-phenyl-2-pyrimidinamine

	Residue definition:  pyrimethanil

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

Calamondins, citrus citron, citrus

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S. Funk, 01/13/2009.

Pyrimethanil	Summary of Analytical Chemistry and Residue Data	DP# 361301

Page   PAGE  12  of   NUMPAGES  17


[Federal Register Volume 86, Number 84 (Tuesday, May 4, 2021)]
[Notices]
[Page 23713]
[FR Doc No: 2021-09357]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP21-751-000]

ConocoPhillips Company, Direct Energy Business Marketing, LLC,
Exelon Corporation, NextEra Energy Marketing, LLC v. Panhandle Eastern
Pipe Line Company, LP; Notice of Complaint

    Take notice that on April 23, 2021, pursuant to section 5 of the
Natural Gas Act, 15 U.S.C. 717d (2018), and Rule 206 of the Rules of
Practice and Procedures of the Federal Energy Regulatory Commission
(Commission), 18 CFR 385.206 (2021), ConocoPhillips Company, Direct
Energy Business Marketing, LLC, Exelon Corporation, and NextEra Energy
Marketing, LLC (Complainants) filed a formal complaint against
Panhandle Eastern Pipe Line Company, LP (Respondent), alleging that
Respondent's failure to waive operational flow order penalties incurred
after February 15, 2021 is unduly discriminatory, inconsistent with
Commission policy and precedent, and inconsistent with Respondent's
tariff, all as more fully explained in the complaint.
    The Complainants certify that copies of the complaint were served
on the contacts listed for Respondent in the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Comment Date: 5:00 p.m. Eastern Time on May 13, 2021.

    Dated: April 29, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-09357 Filed 5-3-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Proposed Rules]
[Pages 37704-37705]
[FR Doc No: 2014-15579]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 13

[FRL-9910-13-OCFO]

Administrative Wage Garnishment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: Environmental Protection Agency (EPA) is proposing to amend
EPA's claims collection standards to include administrative wage
garnishment. This rule amends the EPA's debt collection regulations to
implement the administrative wage garnishment (AWG) provisions of the
Debt Collection Act of 1982, as amended by the Debt Collection
Improvement Act of 1996 (DCIA). The proposed rule will allow the EPA to
garnish non-Federal wages to collect delinquent non-tax debts owed the
United States without first obtaining a court order. In the Rules and
Regulations section of this Federal Register we are approving an
amendment to EPA's regulations on claims collection standards by using
administrative wage garnishment as a direct final rule without a prior
proposed rule. If we receive no adverse comment, the direct final rule
will go into effect and we will not take further action on this
proposed rule.

DATES: Written comments must be received by August 1, 2014.

ADDRESSES: Submit your comments by one of the following methods:
    1. Email<EMAIL_ADDRESS>    2. Fax:<PHONE_NUMBER>.
    3. Mail: OCFO-2014-0001; FRL-9910-13-OCFO, FPPS c/o Anita Jones,
OCFO/OFM/FPPS, Mailcode 2733R, Environmental Protection Agency, 1300
Pennsylvania Ave. NW., Washington, DC 20460.
    Comments may be submitted electronically by following the detailed
instructions in the ADDRESSES section of the direct final rule located
in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: FPPS c/o Anita Jones, OCFO/OFM/FPPS,
Mailcode 2733R, Environmental Protection Agency, 1300 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    This proposed rule implements the administrative wage garnishment
provisions in section 31001(o) of the Debt Collection Improvement Act
of the 1996 (DCIA), Public Law 104-134, 110 Stat. 1321-358, codified as
31 U.S.C. 3720D. Under the administrative wage garnishment provisions
of the DCIA, Federal agencies may garnish administratively up to 15
percent of the disposal pay of a debtor to satisfy a delinquent non-tax
debt owed to the United States. Prior to the enactment of the DCIA,
Federal agencies were required to obtain a court judgment before
garnishing non-Federal wages. Section 31001(o) of the DCIA preempts
State laws that prohibit wage garnishment or otherwise govern wage
garnishment procedures.
    As authorized by the DCIA, a Federal agency collecting a delinquent
non-tax debt may garnish a delinquent debtor's wages in accordance with
regulations promulgated by the Secretary of the Treasury. The Bureau of
Fiscal Services, a bureau of the Department of the Treasury (Treasury),
is responsible for promulgating the regulations implementing this and
other debt collection tools established by the DCIA. The Bureau of
Fiscal Services published its final rule at 63 FR 25136, May 6 1998,
(Treasury Final Rule) and published technical amendments at 64 FR
22906, 22908, April 28, 1999 and 66 FR 51867, 51868, October 11, 2001.
The Treasury Final Rule, as amended, is published in Sec.  285.11 of
title 31 of the Code of Federal Regulations. Pursuant to 31 CFR 285.11
(f), Federal agencies must either prescribe regulations for the conduct
of AWG hearings consistent with the procedural requirements set forth
in the Treasury Final Rule or adopt Sec.  285.11 without change by
reference.

Basic Provisions

    In accordance with the requirements of the DCIA and the
implementing regulations at 31 CFR 285.11, the EPA is adopting the
provisions of 31 CFR 285.11concerning administrative wage garnishment,
including the hearing procedures described in 31 CFR 285.11(f).

Use of the Direct Final Rule

    This document proposes to take action on amending EPA's regulations
on claims collection standards by using administrative wage
garnishment. We have published a direct final rule amending EPA's
regulations on claims collection standards by using administrative wage
garnishment in the ``Rules and Regulations'' section of today's Federal
Register because we view this as a noncontroversial action and
anticipate no adverse comment. We have explained our reasons for this

action in the preamble to the direct final rule.
    If we receive no adverse comment, we will not take further action
on this proposed rule. If we receive adverse comment, we will withdraw
the direct final rule and it will not take effect. We would address all
public comments in any subsequent final rule based on this proposed
rule.
    We do not intend to institute a second comment period on this
action. Any parties interested in commenting must do so at this time.
For further information, please see the information provided in the
ADDRESSES section of this document.

    Dated: June 23, 2014.
Jeanne Conklin,
Acting Director, Office of Financial Management.
[FR Doc. 2014-15579 Filed 7-1-14; 8:45 am]
BILLING CODE 6560-50-P


well as some comments that suggest specific outreach programs, such as:
•
Providing an expanded program that would educate and train all stakeholders,
including substantially more and varied educational programs before the full
enforcement of the IFR, and escalating training efforts in the area of shipper and
carrier education and compliance;
•
Establishing an effective mechanism for disseminating answers to specific
questions to affected persons;
•
Providing enforcement guidance that addresses specific enforcement issues, such
as enforcement of the food facility registration requirements at the time of prior
notice submission and describing enforcement procedures in detail;
•
Providing guidelines on the procedures to submit prior notice either via FDA’s
PNSI or CBP’s ABI, such as instructions on cancellation or change of a prior
notice and descriptions on what is meant by identifying goods by the common,
usual or market name;
•
Explaining procedures of the rule in foreign languages and establishing point of
contacts in foreign countries;
•
Publicizing the rule to individual Americans who will travel abroad, and making
compliance with it a simple, practicable, and straight forward process;
•
Providing a web-based tutorial;
•
Using CBP’s ABI Administrative Messages to announce changes in PNSI;

316
•
Establishing an FDA and CBP agency-industry working group and/or a more
formal advisory committee with representatives of various industry groups;
•
Improving staffing on the “hotline” and/or creation of an exclusive Help Line
staffed with individuals with the requisite technical expertise and the ability to
resolve operational problems as they arise;
•
Creating dedicated e-mail addresses within FDA to which specific questions can
be addressed and/or specific e-mail addresses for different technical and
operations areas;
•
Providing prompt information to submitters regarding inadequacies or
inaccuracies in prior notice, including shipment level feedback to the filer; and
•
Holding public meetings before the final rule takes effect to ensure that all
affected parties understand the rule and can be heard.
(Response) We will provide outreach and training on the final rule as resources permit.
At a minimum, we will provide guidance and instructions on the process for filing prior notice
on our web site.  This guidance, along with detailed instructions on the use of PNSI, including
step-by-step help, is available at http://www.cfsan.fda.gov/~furls/helpf.html.
We agree with the recommendation to establish an effective mechanism for
disseminating answers to specific questions to industry, and have issued guidance documents for
each of the rules we have issued to implement the authorities in the Bioterrorism Act that provide
our response to the frequently asked questions (FAQs), including the prior notice IFR.  We
anticipate doing the same for this final rule.  These guidance documents are designed to help
affected parties comply with the legal requirements established by the various rules.  We intend
to issue additional guidance as new questions arise and as resources permit.

317
In terms of providing enforcement guidance, in December 2003, FDA and CBP issued a
CPG that stated that, until August 12, 2004, the two agencies generally would utilize
communication and education strategies with escalating imposition of civil monetary penalties
rather than refusal of shipments.  The two agencies revised the CPG in June 2004, August 2004
(August 16, 2004; 69 FR 50389), November 2004, March 2005, and November 2005 (November
14, 2005; 70 FR 69160), as our enforcement policies changed and evolved.  Published elsewhere
in this issue of the FEDERAL REGISTER is a notice of availability for the Prior Notice Final
Rule Draft CPG, which describes FDA’s and CBP’s proposed policies for enforcing this final
rule.  A copy of the CPG may be found at http://www.fda.gov/ora under “Compliance
References.”
Generally, FDA enforcement procedures regarding imports are provided in FDA’s
Regulatory Procedures Manual, Chapter 9.  This guidance is posted at
http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9/default.htm.
FDA agrees, in part, with the recommendation about providing user guidelines and has
provided guidance and instructions on the process for filing prior notice.  This guidance, along
with detailed instructions on the use of the PNSI, including step-by-step help, is available at
http://www.cfsan.fda.gov/~furls/helpf.html.  Instructions for contacting FDA with questions
about prior notice are also available at that web site.
FDA cannot provide specific instructions on the use of ABI software to file prior notice,
as that software is developed and made available through private vendors.  Users should contact
their vendor for specific instructions on the use of their ABI software.  CBP does regularly issue
to filers ABI Administrative Messages which provide instruction and guidance regarding
submission of prior notice through ABI/ACS.

318
As part of our outreach efforts for the prior notice IFR, we issued a number of documents
explaining the requirements of the IFR and/or PNSI and provided them on our Web site in
English and one or more other languages, including:
•
FDA Industry Systems, Index of Help Pages at
http://www.cfsan.fda.gov/~furls/helpol.html) (also available in Spanish);
•
HELP:  Getting Started: Create New Account Quick Start Guide) (also
available in Spanish);
•
OUTREACH:  Overview of Prior Notice Interim Final Rule (Slide
Presentation) (also available in Arabic, French, Malay and Spanish);
•
Booklet: What You Need to Know About Prior Notice of Imported Food
Shipments (also available in French and Spanish); and
•
Fact Sheet on the Interim Final Rule - Prior Notice of Imported Food
Shipments (also available in French, Malay, Polish, Portuguese, Spanish,
Arabic, Chinese, Hindi, and Japanese).
We also have an “FDA Food and Cosmetic International/Foreign Language Documents
and Videos,” which is a list of all food (and cosmetic) documents that have been translated and
the languages in which they are available on our Web site at
http://www.cfsan.fda.gov/~mow/internat.html.  Many of the documents describing prior notice
requirements and guidance have been translated into foreign languages.
FDA does not currently maintain staff in foreign countries.  However, FDA has
developed the Beyond our Borders initiative, which includes plans to build an on-the-ground
presence for FDA in Asia, Europe, Latin America, and the Middle East.  In March of 2008, we
received approval from the U.S. State Department to establish eight full time permanent FDA

319
positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from
the Chinese government.  Furthermore, CBP, U.S. State Department, and USDA Food
Agricultural Service staff are located at U.S. Embassies in many foreign countries.  These U.S.
government entities frequently provided assistance to foreign stakeholders, including foreign
government officials and private companies, in understanding the requirements of various U.S.
regulations, including those provided in our Bioterrorism Act regulations. We will routinely
update these U.S. officials abroad about changes to and implementation of this prior notice final
rule.
As resources permit, we also will continue to translate guidance documents and system
instructions into other languages.
FDA agrees with the comment requesting publicizing the rule to individual Americans
who will travel abroad, and making compliance with it a simple, practicable, and straight
forward process.  CBP Publication # 0000-0512, revised January 13, 2005, Know Before You
Go - Regulations for U.S. Residents, is posted at
http://www.cbp.gov/xp/cgov/travel/vacation/kbyg/.  This publication is the primary CBP
guidance document concerning import regulations targeted to travelers and contains information
about the prior notice final rule’s requirements for importation of food.  In addition to providing
information about prior notice requirements, the publication also provides a link to FDA’s Web
site at www.fda.gov/oc/bioterrorism/bioact.html.
FDA also agrees with the comment that requests us to provide a web-based tutorial.
Since October 2003, FDA has provided a PNSI tutorial in the form of step-by-step help on its
web site (http://www.cfsan.fda.gov/~furls/helpf.html).  FDA welcomes any additional comments

320
or suggestions on how to improve the help information; these can be submitted to the PNC using
the phone number or e-mail provided on that web page.
FDA and CBP agree that operational issues impacting ABI filers should be announced
using Administrative Messages, and intend to continue to use that system, as we have routinely
done since December 2003.  When appropriate, information about the PNSI system will also be
announced both on the FDA web site and through CBP’s Administrative Messages.
CBP also has established avenues of communication with trade working groups and
ensures FDA’s participation when the subject for discussion is prior notice.  FDA does not plan
to establish a formal advisory committee to address prior notice.
FDA agrees with the comment to improve help desk staffing, as resources permit.  Our
website contains a tutorial on how to submit a registration for a facility subject to the
requirements at 21 CFR part 1, subpart H.  In addition, the PNC staff can answer questions about
how to submit prior notice.  Questions regarding clarification of the rule that are not addressed in
this preamble or existing publications should be submitted to FDA at <FONT STYLE="font-size<EMAIL_ADDRESS>STYLE="font-size: 12.00pt">.  We
will generally not provide an individual response to these questions, but will answer them in
Question and Answer Guidance Documents so the information will be broadly available.
FDA has included features in PNSI to inform submitters of many types of inadequacies in
the information provided, such as missing required fields.  FDA also has coordinated with CBP
to provide prompt messaging back to users when Prior Notice is filed through ACS.  FDA notes
that certain inaccuracies cannot be identified electronically, but could be detected in an intensive
prior notice review (e.g., the packaging of an actual shipment (12 oz. cans of tuna fish) does not
match the prior notice data submitted for that shipment (e.g., 6 oz. cans of tuna fish)).

321
With respect to holding public meetings to provide an opportunity for parties to voice
their opinions on the IFR, FDA and CBP published the IFR on October 10, 2003, and opened the
comment period through December 24, 2003.  We reopened the comment period from April 14,
2004, through July 13, 2004.  We reviewed 320 timely comments that raised multiple issues, and
have considered those comments as we developed this final rule.  We also held numerous
outreach meetings both domestically and abroad--in person and by video conferencing--to
explain the requirements of the IFR to affected parties and answer questions of clarification to
ensure all were able to provide meaningful comment to FDA and CBP.  The comment period
was the time for all parties to be heard on the provisions of the IFR. While the agencies
welcome discussion and wanted to ensure that all stakeholders understand their obligations under
the statute and the IFR, the comment period ended July 13, 2004, and the agencies did not
consider comments submitted outside of the open comment periods.
(Comments) Several comments recommend that FDA provide feedback to the industry
detailing areas of noncompliance and compliance.  One foreign government stated its willingness
to work with FDA to increase the level of industry compliance within their country through
outreach and education activities. It requests that FDA provide it on a timely basis detailed
information concerning noncompliance by their industry.  Another comment suggests that FDA
could post on its website a description of the types of errors most commonly observed in filed
prior notices.
(Response) We agree, and have been posting on our website summary information about
submission of prior notice, including data on the types of errors.  See
http://www.cfsan.fda.gov/~pn/pnsum.html.  We stated that this information will also be analyzed
to help FDA take appropriate enforcement action when necessary.  FDA presented the Summary

322
Information in two categories: (1) General Interest--Information about the number and types of
prior notices that are being submitted, and which systems are being used to submit them; and (2)
Specific requirements--Information about submission of the required information.  We provided
an initial posting of the summary information and two subsequent updates.  The August 2004
update included some summary information from December 2003 through April 2004 and some
snapshots of activity in July 2004, along with information on specific information requirements
such as registration number and carrier information.
We also posted information summarizing the number of facilities registered pursuant to
21 CFR part 1, subpart H at:  http://www.cfsan.fda.gov/~furls/ffregsum.html.  This summary
includes a breakdown of the number of registered facilities by country and U.S. state.
4. Enforcement Timeframe
(Comments) Many comments state that because FDA and CBP have not informed prior
notice submitters of specific deficiencies in their submissions, FDA must extend the enforcement
date of the rule to allow more time to communicate errors and allow adequate time to fix them.
One comment suggests that the agencies should develop and implement a notice-specific
informational system that provides detailed feedback to submitters when a prior notice is deemed
to be non-compliant.  Another comment states that exporters should be advised of non-compliant
shipments in order to take corrective action prior to the shift to full enforcement.  One comment
believes that part of the phase-in period should include a feedback program to let brokers know
which importers and corresponding transactions are handled with inadequate or no prior notice.
The comment states that this program should be developed in conjunction with the industry to
define measurements (history profile and/or transactional), and determine what the notification
process should be.  One comment encourages FDA to expeditiously publish a notice that it

323
intends to continue outreach and delay enforcement of the regulation so that the business
community may have a greater opportunity for education, training, and continued dialogue with
the agencies.  Other comments recommend a delay in the final phase of enforcement until all
systems are fully operational.
(Response) FDA disagrees.  The obligation to comply with applicable regulations is on
the parties subject to a regulation as specified therein; FDA does not have an obligation to inform
all prior notice submitters of specific deficiencies in their submissions before beginning
enforcement of a rule.  FDA and CBP, however, were cognizant of the potential effect the prior
notice IFR could have on trade and thus, after publication of the IFR, FDA published guidance
that included a transition period during which we emphasized education to achieve compliance,
rather than general refusal of non-compliant shipments (the December 2003 Prior Notice Interim
Final Rule CPG) (68 FR 69708).  In addition, during the prior notice transition periods from
April 2004 through April 2005, we provided compliance summaries that informed submitters,
and those who transmit on their behalf, of the major areas of deficiencies with respect to missing
data elements.  These represented the general deficiencies we were seeing in prior notice
submissions during the educational transition period (see
http://www.cfsan.fda.gov/~pn/pnsum.html).  The compliance summaries also generally
described the deficiencies in prior notices that are not confirmed for review (e.g., failure to
provide a valid registration number).  However, we do not plan to communicate submission
deficiencies to other than the submitter and transmitter.  FDA believes that the effective date of
180 days after publication of the final rule provides sufficient time for the business community to
become familiar with all the provisions of the final rule.  Moreover, we plan to conduct outreach
after publication of the final rule to affected industry and other governments, as resources allow.

324
These efforts will focus on changes to the final rule.  Given the delayed effective date, the fact
that the changes in the final rule are not very extensive, and the public’s experience in complying
with the IFR, FDA believes there is no need for a phased-in enforcement approach similar to
what was done for the IFR.
(Comments) One comment states that if FDA discovers that a large number of problems
are experienced during the grace period between publication of this final rule and the effective
date, FDA should consider extending the effective date, especially for first time offenders.
(Response) FDA believes that the 180 day delay in effective date is adequate for affected
parties to become familiar with all the provisions in the Prior Notice Final Rule.  While we do
not anticipate extending the effective date past 180 days, we intend to take into account the
circumstances of the violation in enforcing the final rule.
5. Enforcement Penalties
(Comments) One comment requests that the agencies publish procedures that clearly
define what types of penalties will be issued for failure to comply under § 1.284 and to whom.
(Response) Sections 1.283 and 1.284 of the final rule describe the consequences for
failing to submit adequate prior notice or otherwise failing to comply with the final rule.  We
believe these adequately describe the types of penalties.  The Prior Notice Final Rule Draft CPG
describes our proposed enforcement policies, and states, for example, that we intend to focus our
resources on more serious violations and repeat or flagrant violations.
Civil monetary penalties, which are issued by CBP, may also be assessed in response to a
prior notice violation.  CBP has posted a variety of publications that explain both the
administrative process for fines, penalties, forfeitures, and liquidated damages, such as: “What
Every Member of the Trade Community Should Know About: Customs Administrative

325
Enforcement Process: Fines, Penalties, Forfeitures and Liquidated Damages,” which is posted at:
http://www.cbp.gov/linkhandler/cgov/toolbox/legal/informed_compliance_pubs/penalties/icp052
.ctt/icp052.pdf, and “What Every Member of the Trade Community Should Know About:
Mitigation Guidelines: Fines, Penalties, Forfeitures and Liquidated Damages,” which is posted at
http://www.cbp.gov/linkhandler/cgov/toolbox/legal/informed_compliance_pubs/penalties/icp069
.ctt/icp069.pdf.
N. The Joint Food and Drug Administration-Customs and Border Protection Plan for Increasing
Integration and Assessing the Coordination of Prior Notice Timeframes
We stated in the preamble to the IFR (68 FR 58974 at 58995) that FDA and CBP would
publish a plan, including an implementation schedule, to achieve the goal of a uniform,
integrated system and to coordinate prior notice timeframes for air and truck modes of
transportation with timeframes finalized by CBP when they finalize their rule entitled “Required
Advance Electronic Presentation of Cargo Information,” all while fulfilling the Bioterrorism Act
mandates.  For this reason, as well as to obtain comments on other aspects of the rule, we issued
an IFR, with an opportunity for public comment for 75 days.  Moreover, to ensure that those who
comment on this IFR would have had the benefit of actual experience with the systems,
timeframes, and data elements, FDA also stated it intended to reopen the comment period for an
additional 30 days to coincide with the issuance of the plan by FDA and CBP relating to
timeframes. We extended this comment period twice on April 14, 2004, and May 18, 2004,
thereby providing an opportunity for affected persons to comment for 165 days.
In April 2004, FDA and CBP announced the Joint Food and Drug Administration-
Customs and Border Protection Plan for Increasing Integration and Assessing the Coordination
of Prior Notice Timeframes (the Plan).

326
The comments addressing the Plan are discussed in the following paragraphs.  Comments
addressing our assessment of reducing the prior notice timeframes are found earlier in section
III.F (“When must prior notice be submitted to FDA?” (§ 1.279)) of this document.  We respond
to the other questions (e.g., special programs and flexible alternatives) raised in our April 14
th
reopening of the comment period in sections III.D (“What is the Scope of this subpart?” (§
1.277)) and III.M (Outreach and Enforcement) of this preamble.
1. Increased Integration
FDA and CBP have increased their integration and are continuing to do so in the
following ways:
•
Co-location of all FDA Prior Notice staff with CBP's targeting staff;
•
Further refinement to FDA's targeting rule sets in CBP's targeting system,
coupled with additional training in targeting techniques;
•
Continued targeting support from CBP and other Federal law enforcement
analysts; and
•
Enhancement of communications and cooperation with CBP to facilitate
information exchange and to ensure expeditious access and examination of
food shipments FDA has decided to inspect upon arrival.
(Comments) One comment suggests that FDA should consider performing the OASIS
review concurrently with the “FDA BTA review” to eliminate duplicative work and burdens on
both the importing community and FDA.  Another comment suggests that FDA coordinate the
prior notice procedure with FDA’s “Hold Intact Notice” so that FDA can avail itself of the
opportunity to identify in advance shipments for inspection, sampling or detention, or permit the
shipment to pass and be delivered without delay.

327
(Response) FDA disagrees.  As we previously explained in an earlier response in section
III.J.11 of this document, FDA does not agree that doing the OASIS review under section 801(a)
of the act concurrently with the prior notice review under section 801(m) of act would be
beneficial to industry or FDA.  Because the section 801(m) review must occur prior to arrival,
concurrent section 801(a) and section 801(m) reviews also would have to occur prior to arrival.
FDA believes such a concurrent process would be inefficient and impractical and would likely
increase congestion at the ports of arrival.
(Comments) Comments state that co-locating FDA PNC staff with CBP’s targeting staff
is a positive step since the two agencies’ personnel are both accountable for the risk analysis
process, and thus, both agencies’ personnel can easily interact and share information, leading to
increased efficiencies and integration of the risk analysis process.
(Response) FDA agrees and has co-located the PNC with CBP’s targeting staff.
(Comments) Comments strongly support further refinement of FDA’s targeting rule sets
in order to maintain and improve the risk analysis system to flag specific shipments for security
concerns.  Comments further support the continuing plan to target shipments for which little is
known, while maintaining expedited processing for those shipments and importers that are well
known and have provided FDA and CBP with the means by which they can assure general
compliance.  These comments also argue that products subject to FDA’s prior notice
requirements should be eligible for full expedited processing and information transmission
benefits allowed with C-TPAT, FAST, and any other similar programs established in the future.
One comment specifically encourages FDA and CBP to incorporate the current information
contained within these programs and allow for the removal of the maximum number of flags

328
within the risk analysis system for those companies that demonstrate their compliance by
participation in these additional security programs.
(Response) FDA agrees that refining our targeting rule sets helps to improve both
agencies’ risk analysis systems.  As we discussed previously, FDA has decided not to consider
any special programs, such as C-TPAT and FAST, in implementing the prior notice rule.
(Comments) All the comments favor initiatives to provide additional training of FDA
staff in targeting techniques that will increase the efficiency and effectiveness of the border
crossing systems.  One comment particularly notes that additional training should be targeted
towards those individuals and issues that will provide measurable additional value to the prompt
and efficient release of compliant cargo.
(Response) Any effective targeting technique allows for the identification of food likely
to be at risk for adulteration based on a scientific risk assessment.  Targeted training will be
provided, as resources permit.
(Comments) Comments support enhanced communications and cooperation with CBP to
facilitate information exchange and ensure fast access to foods that are subject to prior notice
holds.  Comments state that this will be critical to the food industry, as any delays will translate
into added costs and inefficiencies to their current supply chain.  One comment encourages FDA
and CBP to integrate technologies used for implementing the Bioterrorism Act with NEXUS, US
VISIT, FAST, C-TPAT, and other programs at the border.
(Response) FDA agrees that exchanging information between the agencies is important to
evaluation of and response to food safety and security challenges.

329
(Comments) One comment encourages FDA and CBP to work with their Canadian
counterparts to ensure that information is shared and technologies are working in parallel to
make crossing the border seamless, efficient, and safe.
(Response) FDA agrees that exchange of information between its international
counterparts, when feasible, is critical to evaluation and response to food safety and security
challenges.
(Comments) One comment notes that FDA recently announced the signing of an MOU
with CBP to commission CBP officers in ports and other locations to conduct investigations and
examinations of imported foods on behalf of FDA.  The comment questions whether this would
have any consequences on the selections for controls by CBP officials stationed in EU ports.
(Response) Investigation and examination of food as a result of prior notice is conducted
upon or after arrival of the food in the United States.  Therefore, the MOU should not have any
consequences on CBP operations at EU ports.
2. General Comments on the Plan
The Plan as announced in April 2004 and revised in November 2004 outlines the
following:
•
From November 1, 2004, to January 3, 2005, we plan to assess existing
procedures and staffing needed to receive, review, and respond to the prior
notices submitted in accordance with the Prior Notice IFR (i.e., 2 hours before
arrival by land by road; 4 hours before arrival by air or by land by rail; and 8
hours before arrival by water).
•
From January 4, 2005, to February 3, 2005, we intend to identify what
changes to work practices and staffing would be necessary to determine if

330
FDA could continue to receive, review, and respond to all prior notice
submissions with reduced timeframes (e.g., 1 hour/30 minutes before arrival
by land by road; 2 hours before arrival by land by rail; and by "wheels up" for
flights originating in North and Central America, South America (north of the
Equator only), the Caribbean, and Bermuda; otherwise 4 hours before arrival
by air).
•
From February 4, 2005, to May 3, 2005, we plan to implement necessary
changes and make appropriate adjustments to ensure we could receive,
review, and respond to all prior notice submissions with reduced timeframes.
Under the Bioterrorism Act, any timeframe must be sufficient to receive, review, and
respond to prior notice submissions, as set out in section 801(m)(2)(A) of the act, 21 U.S.C.
801(m)(2)(A). The agencies emphasized that the evaluation of whether to reduce the timeframes
for prior notice review will depend on the level of compliance industry achieves during the
assessment.
(Comments) Numerous comments concur with the proposed joint FDA-CBP plan for
increasing integration of both agencies’ activities, as this would eliminate the requirement for
importers to maintain two different timeframes for submission of data.  One comment concurs
with the joint plan and states that it would minimize procedures and costs for firms.  One
comment states that it was confident that, with proper planning and development, additional
integration of the security processes and the differing timeframes can be coordinated through the
actions outlined in the published joint plan.
(Response) FDA agrees that increased integration of activities, including timeframes
when appropriate and feasible, would be advantageous, provided FDA still is able to meet its

331
statutory obligation to receive, review, and respond to prior notice. As discussed previously (see
section III.F When must prior notice be submitted to FDA? (§ 1.279)), FDA conducted an
assessment of FDA response times with reduced timeframes and determined that if it changed
the prior notice timeframes to be consistent with those of CBP's advance electronic information
rule, the agency would not have adequate time to receive, review, and respond to the prior
notices.  Moreover, commerce actually would be adversely impacted by shorter prior notice
timeframes for submission, because this would significantly increase the number of shipments
where FDA would not be able to decide whether it should examine the food at the port of arrival
by the end of the timeframe.  Such shipments would be delayed at the port of arrival until FDA
has either completed its review or decided to examine or not examine the food at the port or
arrival without the benefit of a complete review.  Accordingly, FDA has retained the timeframes
in the IFR.
(Comments) One comment requests that FDA explain why the maritime transportation


[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Pages 40036-40037]
[FR Doc No: 2018-17372]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2002-0059; FRL-9982-14-OW]

Proposed Information Collection Request; Comment Request; Safe
Drinking Water Act State Revolving Fund Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Safe Drinking Water
Act State Revolving Fund Program'' (EPA ICR No. 1803.08, OMB Control
No. 2040-0185) to the Office of Management and Budget (OMB) for review
and approval in accordance with the Paperwork Reduction Act (PRA).
Before doing so, the EPA is soliciting public comments on specific
aspects of the proposed information collection as described in the
SUPPLEMENTARY INFORMATION section. This is a proposed extension of the
ICR, which is currently approved through April 30, 2019. An Agency may
not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Comments must be submitted on or before October 12, 2018.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2002-0059, online using www.regulations.gov (our preferred method), by
email to [email protected], or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Howard Rubin, Drinking Water
Protection Division, Office of Ground Water and Drinking Water, 4606M,
U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. The
EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval. At that time, the EPA will issue another Federal
Register notice to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB.
    Abstract: The Safe Drinking Water Act (SDWA) Amendments of 1996
(Pub. L. 104-182) authorized the creation of the Drinking Water State
Revolving Fund (DWSRF; the Fund) program in each state and Puerto Rico,
to assist public water systems in financing the costs of infrastructure
needed to achieve or maintain compliance with the SDWA requirements and
to protect public health. The SDWA, section 1452, authorizes the
Administrator of the EPA to award capitalization grants to the states
and Puerto Rico which, in turn, provide low-cost loans and other types
of assistance to eligible drinking water systems. States can also
reserve a portion of their grants to conduct various set-aside
activities. The information collection activities will occur primarily
at the program level through the (1) Capitalization Grant Application
and Agreement/State Intended Use Plan; (2) Biennial Report; (3) Annual
Audit; (4) Assistance Application Review; and (5) DWSRF National
Information Management System and the Projects and Benefits Reporting
System.
    (1) Capitalization Grant Application and Agreement/State Intended
Use Plan: The state must prepare a Capitalization Grant Application
that includes an Intended Use Plan (IUP), outlining in detail how it
will use all the funds covered by the capitalization grant. The state
may, as an alternative, develop the IUP in a two-part process, with one
part identifying the distribution and uses of the funds among the
various set-asides in the DWSRF program and the other part dealing with
project assistance from the Fund.
    (2) Biennial Report: The state must agree to complete and submit a
Biennial Report on the uses of the capitalization grant. The scope of
the report must cover assistance provided by the Fund and all other
set-aside activities included under the Capital Grant Agreement. States
that jointly administer DWSRF and Clean Water State Revolving Fund
(CWSRF)

programs, in accordance with the SDWA, section 1452(g)(1), may submit
reports (according to the schedule specified for each program) that
cover both programs.
    (3) Annual Audit: A state must comply with the provisions of the
Single Audit Act Amendments of 1996. Best management practices suggest
and the EPA recommends that a state conduct an annual independent audit
of its DWSRF program. The scope of the report must cover the DWSRF and
all other set-aside activities included in the Capitalization Grant
Agreement. States that jointly administer DWSRF and CWSRF programs, in
accordance with the SDWA, section 1452(g)(1), may submit audits that
cover both programs but which report financial information for each
program separately.
    (4) Assistance Application Review: Local applicants seeking
financial assistance must prepare and submit DWSRF loan applications.
States then review completed loan applications and verify that proposed
projects will comply with applicable federal and state requirements.
    (5) DWSRF National Information Management System (DWNIMS) and the
Projects and Benefits Reporting System (PBR): To ensure that funds are
being used in an expeditious and timely manner for eligible projects
and expenses, states must annually enter state-level financial data
into the DWNIMS and quarterly enter project-level data into the PBR.
    Form numbers: None.
    Respondents/affected entities: Entities affected by this action are
states and local governments.
    Respondent's obligation to respond: Required to obtain or retain a
benefit per the Safe Drinking Water Act, section 1452(g)(1).
    Estimated number of respondents: 379 state and local respondents
(total).
    Frequency of response: Varies by requirement (i.e., quarterly,
semi-annually, and annually).
    Total estimated burden: 88,792.5 hours (per year) for state and
local respondents. Burden is defined at 5 CFR 1320.03(b).
    Total estimated cost: $3,355,516 (per year) for state and local
respondents.
    Changes in estimates: The EPA expects a decrease in the total
estimated respondent burden cost compared with the ICR currently
approved by OMB. The change in cost is due to moving from contractor-
provided hourly cost rates to Bureau of Labor Statistics (BLS) provided
hourly cost rates. Using BLS rates will ensure that the ICR is more
transparent and replicable. The present BLS rates are lower than
historical contractor-provided rates.

    Dated: August 2, 2018.
Peter Grevatt,
Director, Office of Ground Water & Drinking Water.
[FR Doc. 2018-17372 Filed 8-10-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Page 61836]
[FR Doc No: 2015-26174]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2015-0002]

Notice of Adjustment of Statewide Per Capita Impact Indicator

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: FEMA gives notice that the statewide per capita impact
indicator under the Public Assistance program for disasters declared on
or after October 1, 2015, will remain the same.

DATES:  Effective Date: October 1, 2015, and applies to major disasters
declared on or after October 1, 2015.

FOR FURTHER INFORMATION CONTACT: William Roche, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: 44 CFR 206.48 provides that FEMA will adjust
the statewide per capita impact indicator under the Public Assistance
program to reflect changes in the Consumer Price Index for All Urban
Consumers published by the Department of Labor.
    FEMA gives notice that the statewide per capita impact indicator
will remain at $1.41 for all disasters declared on or after October 1,
2015.
    FEMA bases the adjustment on an increase in the Consumer Price
Index for All Urban Consumers of 0.2 percent for the 12-month period
that ended in August 2015. The Bureau of Labor Statistics of the U.S.
Department of Labor released the information on September 16, 2015.

Catalog of Federal Domestic Assistance No. 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters).

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2015-26174 Filed 10-13-15; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 241 (Thursday, December 15, 2011)]
[Notices]
[Pages 78057-78059]
[FR Doc No: 2011-32143]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65929; File No. SR-NASDAQ-2011-171]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to Post-Only Order

December 9, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 6, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or
``NASDAQ'')

filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NASDAQ is filing with the Securities and Exchange Commission
(``Commission'') a proposal for the NASDAQ Options Market (``NOM'') to
amend Chapter VI, Trading Systems, Section 1, Definitions, to change
the definition of ``Post-Only Order,'' as described further below, and
delay its implementation until February 2012.
    The text of the proposed rule change is available at http:/
nasdaq.cchwallstreet.com/, at NASDAQ's principal office, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of those statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, Proposed Rule Change

1. Purpose
    The Exchange recently adopted a new order type called Post-Only
Order,\3\ which is an order that will not remove liquidity from the
System and is to be ranked and executed on the Exchange or cancelled,
as appropriate, without routing away to another market.\4\ Post-Only
Orders may not have a time-in-force designation of Good Til Cancelled
(``GTC'').\5\
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    \3\ See Securities Exchange Act Release No. 65761 (November 16,
2011), 76 FR 72230 (November 22, 2011)(SR-NASDAQ-2011-152).
    \4\ Post-Only Orders are evaluated at the time of entry with
respect to locking or crossing other orders as follows: (i) If a
Post-Only Order would lock or cross an order on the System, the
order will be re-priced to $.01 below the current low offer (for
bids) or above the current best bid (for offers) and displayed by
the System at one minimum price increment below the current low
offer (for bids) or above the current best bid (for offers); and
(ii) if a Post-Only Order would not lock or cross an order on the
System but would lock or cross the national best bid or offer as
reflected in the protected quotation of another market center, the
order will be handled pursuant to Chapter VI, Section 7(b)(3)(C).
    \5\ See NOM Rules, Chapter VI, Section 1(g).
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    At this time, the Exchange proposes to amend the definition in
Chapter VI, Section 1(e)(11), to provide that, like the time-in-force
designation of GTC, a Post-Only Order cannot have a time-in-force
designation of Immediate or Cancel (or IOC). Immediate or Cancel, which
is described in Chapter VI, Section 1(g)(2), means for orders so
designated, that if after entry into the System a marketable order (or
unexecuted portion thereof) becomes non-marketable, the order (or
unexecuted portion thereof) shall be canceled and returned to the
entering participant. Accordingly, IOC orders are available to trade
immediately and, if not executed, are then cancelled back to the
Participant.
    The Exchange believes that the IOC time-in-force designation is not
appropriate for Post-Only Orders, because IOC orders cannot post on the
book and Post-Only Orders cannot remove liquidity, such that there
would be no logical outcome for an IOC Post-Only Order. Accordingly,
the Exchange is proposing to expressly state in its rules that such
orders do not exist.
    In addition, the Exchange proposes to delay the implementation of
Post-Only Orders to take aforementioned change into account and delay
implementation until February 2012. The Exchange will announce the
specific date that these orders will become available to its membership
via an Options Trader Alert.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \6\ in general, and furthers the objectives of Section
6(b)(5) of the Act \7\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanisms of a free and open
market and a national market system, and, in general, to protect
investors and the public interest, because it better explains an
additional order type on NOM, making clear that the IOC time-in-force
is not available and the order type is not available until February
2012, which the Exchange believes is consistent with just and equitable
principles of trade. Because the Post-Only Order is designed to
encourage displayed liquidity and offer NOM market participants greater
flexibility to post liquidity on NOM, limiting the time-in-force is
consistent with removing impediments to and perfecting the mechanisms
of a free and open market and a national market system.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \8\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\9\
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \10\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6) permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange requests
that the Commission waive the 30-day operative delay in order to
implement this proposal prior to December 8, 2011, because, without
such a waiver, the Exchange's recent filing adopting the new Post-Only
order type would become operative on December 8,

2011.\11\ The Exchange, however, will not be ready to implement the new
order type until February 2012. The Commission believes that waiving
the 30-day operative delay is consistent with the protection of
investors and the public interest, because it will allow the Exchange
to immediately delay the implementation of Post-Only orders, preventing
a gap between when the new order type is operative under the rules and
when the new order type will be implemented and available for use in
February 2012. For these reasons, the Commission designates that the
proposed rule change become operative immediately upon filing.\12\
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    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ See supra note 3.
    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2011-171 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549.

All submissions should refer to File Number SR-NASDAQ-2011-171. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of NASDAQ. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2011-171 and should
be submitted on or before January 5, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-32143 Filed 12-14-11; 8:45 am]
BILLING CODE 8011-01-P