UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

DATE:	24 March 2009

SUBJECT:	Boscalid.  Petition   SEQ CHAPTER \h \r 1 Requesting the
Establishment of a Permanent Tolerance for Residues Associated with Food
Use of the Fungicide on Imported Coffee.  Summary of Analytical
Chemistry and Residue Data.

PC Code:  128008	DP Barcode:  355919

Decision Number:  394535	Registration Number:  NA

Petition Number:  8E7367	Regulatory Action:  Amended Section 3

Risk Assessment Type:  NA	Case Number:  NA

TXR Number:  NA	CAS Number:  188425-85-6

MRID Numbers:  47353903 to -06	40CFR §180.589

Chemical Class:  Carboxamide (Anilide) 			      Fungicide	Trade Name:
Cantus®

FROM:	  SEQ CHAPTER \h \r 1 William T. Drew, Chemist

		Alternative Risk Integration and Assessment (ARIA) Team

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

		Registration Division (RD), 7505P

THROUGH:	William Cutchin, Acting Senior Scientist

		ARIA/RIMUERB/RD, 7505P

TO:		Tony Kish and Bryant Crowe, RM Team 22

		Fungicide Branch (FB)/RD, 7505P

  SEQ CHAPTER \h \r 1 This data evaluation record (DER) was originally
prepared under contract by Dynamac Corporation (2275 Research Boulevard,
Suite 300; Rockville, MD 20850).  The DER has been reviewed by the
Registration Division (RD), and revised to reflect current Office of
Pesticide Programs (OPP) policies.

Executive Summary

	Boscalid is a carboxamide (anilide) fungicide that inhibits
mitochondrial respiration, thereby inhibiting spore germination, germ
tube elongation, mycelial growth, and sporulation of pathogenic fungi on
the leaf surface.  Boscalid is currently registered to BASF Corporation,
as water-dispersible granule (WDG) formulations, for use on a wide
variety of food/feed crops.

	BASF Corporation has submitted four volumes of coffee field trial data
in support of a petition, PP#8E7367, to establish a tolerance for
residues of boscalid in imported coffee, arising from the proposed use
on coffee grown in Brazil.  It was noted that the current tolerance
action was submitted along with an application for an amended use
pattern on, and tolerance in, bananas (PP#8E7366; D355200; D. Dotson; 24
November 2008).  Section F of PP#8E7367 has proposed the establishment
of a tolerance (without registration) for residues of the fungicide
boscalid [3-pyridinecarboxamide,
2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl)] in or on imported coffee, at
the level listed below.

Coffee	0.05 ppm

	The end-use product (EP) relevant to this tolerance action is Cantus, a
WDG formulation containing 50% of the active ingredient (ai), boscalid.
Cantus is claimed to be effective for the control of Phoma (Phoma
costaricencis) and Ascochyta (Ascochyta coffeae) spots on coffee grown
in Brazil.  Cantus is proposed for one foliar spray treatment to coffee,
at a maximum rate of 0.075 kg ai/ha (0.067 lb ai/A), with a pre-harvest
interval (PHI) of 45 days.

	Boscalid tolerances for plant commodities are listed in 40CFR
§180.589[a][1], and are currently expressed in terms of the parent
compound, boscalid.  Plant commodity tolerances range from 0.05 ppm in
peanuts, and tuberous and corm vegetables (subgroup 1C), to 60 ppm in
leafy greens (subgroup 4A), except head and leaf lettuce.

	  SEQ CHAPTER \h \r 1 The nature of the residue in plants is adequately
understood.  HED has determined that, in target crops, boscalid per se
is the residue of concern (ROC) for purposes of risk assessment and
tolerance expression.

	There are no significant livestock feedstuffs associated with the
proposed use pattern on coffee.  Therefore, no livestock metabolism
data, enforcement methods, storage stability data, or feeding studies
are required to support this petition.  The requirements for rotational
crop data are also not relevant to this petition request, because coffee
crops are typically not rotated, and data for Guidelines 860.1850 and
860.1900 are not required to establish tolerances in imported
commodities.

	An adequate gas chromatograph with mass spectrometer detection (GC/MS)
 SEQ CHAPTER \h \r 1 method (Method D0008) is available for enforcing
tolerances in plant commodities.  The method has been approved by the
Analytical Chemistry Branch (ACB) of the Biological and Economic
Analysis Division (BEAD).  Residues in samples from the coffee field
trials associated with this petition were determined using a
high-performance liquid chromatograph with ultraviolet detection
(HPLC/UV) method (BASF Method 441/0).  This method was adequately
validated prior to, and in conjunction with, the field trial analyses;
the validated limit of quantitation (LOQ) was 0.05 ppm for boscalid in
coffee green beans.

	The requirements for multiresidue methods (MRM) testing data have been
fulfilled.  Residues of boscalid and its hydroxy metabolite were not
adequately recovered using the MRMs.  The MRM data have been forwarded
to FDA for a future updating of PAM, Volume I.

	Adequate storage stability data are available from previous boscalid
petitions.  These data indicate that boscalid is reasonably stable under
frozen conditions in diverse crop matrices for intervals of at least 24
months.  Samples from the coffee trials were stored for a maximum
duration of approximately 16 months prior to residue analysis.  There
are no storage stability issues or corrections that need to be applied
to the results of the coffee field trials.

	Adequate magnitude of the residue data were submitted for coffee.  The
results indicate that residues of boscalid were below the method LOQ
(<0.05 ppm) in all samples of coffee green beans harvested 45 days
following foliar broadcast treatment of coffee plants with the 50% WDG
formulation at 0.134 lb ai/A (2X the proposed maximum use rate).
Residues were also <0.05 ppm in samples treated at the same rate, and
collected at PHIs of 0, 15, 30, and 60 days.  Although the available
coffee field trial data represent 2X the proposed maximum seasonal use
rate specified on the Cantus label, the data will support the proposed
use on coffee grown in Brazil, as well as the proposed raw agricultural
commodity (RAC) tolerance of 0.05 ppm.  However, a revised Section F
should be submitted to correct the commodity definition, (which is
“coffee, green bean”).  The Agency reserves the right to require
additional field trial data, as well as use pattern information, in the
event that boscalid use on coffee grown in countries other than Brazil
is proposed in the future.

	A coffee processing study was not submitted with this petition.  Data
investigating the potential of boscalid residues to concentrate in
roasted coffee beans, and instant coffee are required.

	The Codex Alimentarius Commission has established a maximum residue
limit (MRL) for residues of boscalid in/on coffee beans at 0.05 ppm,
which is in harmony with the tolerance recommended by HED and ARIA/RD.

	Analytical reference standards for boscalid are available at the EPA
National Pesticide Standards Repository.

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry
Deficiencies

	Pending submission of a coffee processing study, and a revised Section
F, there are no residue chemistry issues that would preclude the
establishment of a tolerance for boscalid residues in imported coffee,
arising from the requested use of boscalid on coffee in Brazil.
Provided that the forthcoming human health risk assessment does not
identify any issues of concern, the submitted data support a tolerance
for residues of boscalid in/on imported coffee, at the level listed
below.

Coffee, green bean	0.05 ppm

	860.1520 Processed Food and Feed

	A study investigating the potential of boscalid residues to concentrate
in roasted coffee beans, and instant coffee, is required.  The study
should be conducted at an exaggerated application rate (5X), in order to
obtain sufficient residue levels for the calculation of processing
factors.

	860.1550 Proposed Tolerances

	The petitioner should submit a revised Section F to correct the
commodity definition, as recommended in Table 7, on page 11.

Other Considerations

	HED and ARIA/RD note that there are still outstanding deficiencies
and/or issues (listed below) from an early boscalid petition (PP#1F6313;
D278385; M.J. Nelson; 15 August 2003), which should also be addressed by
the petitioner.  These data gaps do not affect the subject petition.

	1. The petitioner should submit radiovalidation data, demonstrating the
efficiency of the hydrolysis step in the proposed tolerance enforcement
method (DFG S19) for livestock matrices.  These radiovalidation data
will also be used in support of the data collection method (BASF Method
471/0) for livestock matrices.

	2. The petitioner should submit radiovalidation data demonstrating the
efficiency of the microwave hydrolysis step in BASF Method 476/0, which
determines bound residues of boscalid in milk and liver.

	3. Data are required, demonstrating the frozen storage stability of
boscalid residues in processed grape juice over an interval of at least
2 months.

Background

	The chemical structure and nomenclature of boscalid are presented in
Table 1, below.  The physicochemical properties of the technical grade
of boscalid are presented in Table 2, below.

TABLE 1	Boscalid Nomenclature.

Compound structure

Empirical formula	C18H12Cl2N2O

Molecular weight	343.2

Common name	Boscalid

Company experimental name	BAS 510F

IUPAC name	2-chloro-N-(4'-chlorobiphenyl-2-yl)-nicotinamide

CAS name
2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl)-3-pyridinecorboxamide

CAS registry number	188425-85-6

End-use product (EP)	Cantus (50% WDG)

TABLE 2	Physicochemical Properties of Boscalid (Technical Grade).

Parameter	Value	References

Melting point/range (ºC)	142.8-143.8	MRIDs #45404802 and #45404804 to
-09

pH	Does not dissociate in water.

	Relative density (g/cm3 at 20ºC)	1.381

	Water solubility (mg/L at 20ºC)	4.64 at pH 6

	Solvent solubility (g/100 mL at 20ºC)	Acetone			16-20

Ethyl acetate		6.7-8.0

Methanol			4-5

2-Propanol		<0.01

Acetonitrile		4-5

Dichloromethane		20-25

Toluene			2-5

n-Heptane			<0.01

1-Octanol			<0.01

Olive oil			2.9

N,N-DMF			>25

	Vapor pressure (hPa)	7 x 10-9

	Dissociation constant, pKa	None

	Octanol/water partition coefficient, Log (KOW)	2.96

	UV/visible absorption spectrum	UV molecular extinction(e[lmol-1cm-1]) =

3.15 x 104 at 228 nm; 1.53 x 103 at 290 nm.

860.1200 Directions for Use

	The petitioner has submitted a specimen label for Cantus, a WDG
formulation containing 50% boscalid.  The label was affixed with an
approval stamp from Brazil’s Ministry of Agriculture, dated 21
February 2005.  Section B of the petition specifies that the proposed
use is on coffee grown in Brazil only.  Cantus is proposed for the
control of Phoma (Phoma costaricencis) and Ascochyta (Ascochyta coffeae)
spots on coffee.  A summary of the proposed use pattern is summarized in
Table 3, below.

Table 3	Summary of Use Directions for Boscalid.

Use Timing; Type; and Equipment	Formulated Product	Use Rate

(lb ai/A)

[kg ai/ha]	Maximum # of Uses per Season	Max Seasonal Use Rate

(lb ai/A)

[kg ai/ha]	PHI

(Days)	Use Directions and Limitations

Coffee Grown in Brazil

First sign of disease; foliar broadcast;

ground	50% WDG	0.067

[0.075]	1	0.067

[0.075]	45	Application should be made evenly, using a spray volume of
500-1,000 L/ha.

	Conclusions:  The proposed use directions for application on coffee are
adequately described, and sufficient to allow evaluation of the residue
data relative to the proposed use.  Although the available coffee field
trial data represent 2X the maximum use rate specified on the Cantus
label, the data will support the proposed use on coffee grown in Brazil,
because residues were nonquantifiable in all samples.

860.1300 Nature of the Residue - Plants

	PP#1F6313 Residue Chemistry Memo; D278385; M.J. Nelson; 15 August 2003

	HED MARC Decision Memo; D286786; M.J. Nelson; 9 January 2003

	  SEQ CHAPTER \h \r 1 The nature of boscalid residues in target
(primary) crops is adequately understood, based upon acceptable 14C
metabolism studies conducted on grapes, lettuce and beans; these studies
were reviewed in the initial boscalid petition, PP#1F6313.  No
significant metabolism of boscalid occurred in grapes or lettuce;
unchanged parent was the only component identified, accounting for
92-98% and 99% total radioactive residues (TRR), respectively.  In bean
plants, boscalid metabolized slowly; unchanged parent was the major
component identified, accounting for up to 72% TRR in dry bean seeds,
and 99% TRR in bean plants.  Cleavage products,
1-(chlorophenyl)-2-aminobenzene and 2-chloronicotinic acid, were present
in small amounts, accounting for <1% and <10% TRR, respectively.

	HED has concluded that the parent compound, boscalid, is the sole ROC
for risk assessment, and the tolerance expression, for primary (target)
crops.  The cleavage products were not included, based on the limited
cleavage which occurred, and the low levels of their ingestion expected
from dietary and environmental sources.

860.1300 Nature of the Residue - Livestock

	PP#1F6313 Residue Chemistry Memo; D278385; M.J. Nelson; 15 August 2003

	HED MARC Decision Memo; D286786; M.J. Nelson; 9 January 2003

	There are no significant livestock feedstuffs associated with the
proposed use on coffee.  Nonetheless, it has been determined that the
SEQ CHAPTER \h \r 1 nature of boscalid residues in livestock is
adequately understood, based upon acceptable 14C metabolism studies
conducted on lactating goats, and laying hens.  In both the goat and the
hen, parent boscalid, M510F 01 (hydroxy metabolite), and M510F 02
(M510F01 glucuronide) were identified as the major residues, with 10%
TRR.  No amide bridge cleavage products were identified.  Based on the
structural similarity of boscalid and M510F 01, and the fact that the
enzymatic hydrolysis step in the proposed enforcement method will
release M510F 02 back to free M510F 01, HED concluded that the combined
residues of parent BAS 510 F, M510F 01, and M510F02 are the ROCs for
risk assessment, and the tolerance expression, in livestock matrices.

860.1340 Residue Analytical Methods

	DER Reference List (Reviewed for PP#1F6313):

		46351405; Data Collection, BASF Method 445/0

		45405027; Data Collection, BASF Method D9908

		45405028; Tolerance Enforcement, BASF Method D0008

	PP#1F6313 Residue Chemistry Memo; D278385; M.J. Nelson; 15 August 2003

	PMV Results Memo D284510; D. Swineford and E. Kolbe; 12 August 2003

	An adequate GC/MS method (Method D0008) is available for enforcing
boscalid tolerances in plant commodities.  BEAD/ACB concluded that the
method is acceptable for enforcement purposes in plants without the need
for an EPA validation.

	Samples of coffee green beans were analyzed for residues of boscalid
using an HPLC/UV method (BASF Method 441/0), entitled Determination of
BAS 510 F Residues in Potato, Tomato, Garlic, Onion, Carrot, Melon,
Cucumber, Grape and Coffee.  Briefly, samples were extracted with
methanol, and then vacuum filtered through a sintered funnel.  The
filter cake was washed with water/methanol (20:80, v:v).  The filtrate
was then diluted with water, and cleaned up using two C18 cartridges.
Residues were eluted with isooctane/ethyl acetate (90:10, v:v).  The
eluate was put through a silica cartridge, and the residues were eluted
with ethyl acetate.  The silica cartridge eluate was evaporated to
dryness, the residues were dissolved in water/acetonitrile
(ACN)/tetrahydrofuran (THF) (90:5:5, v:v:v), and further cleaned up
using a chromatography pre-column system.  The fraction corresponding to
the interval between 6.0 and 10.3 minutes was collected and diluted with
water/ACN/THF (90:5:5, v:v:v) for HPLC/UV determination of boscalid.
The method LOQ, determined as the lowest level of method validation
(LLMV) was 0.05 ppm for residues of boscalid in coffee green beans.  The
limit of detection (LOD) was not reported.  To verify the adequacy of
the method for data collection, untreated samples of coffee green beans
were fortified with boscalid at levels of 0.05 and 0.50 ppm.  Method
recoveries ranged from 84 to 108%.

860.1360 Multiresidue Methods

	PP#1F6313 Residue Chemistry Memo; D278385; M.J. Nelson; 15 August 2003

	  SEQ CHAPTER \h \r 1 Residues of boscalid and its metabolite, M510F01,
were not adequately recovered using the multiresidue methods.  Protocol
A was not applicable.  Protocol B was not applicable for boscalid, and
yielded inconsistent recoveries of M510F01.  Residues of boscalid and
its hydroxy metabolite, M510F01, had good responses with GC/ECD on a
DB-1 column, under Protocol C.  Neither analyte was recovered at >30%
using Protocols D, E and F.  The study has been forwarded to FDA for a
future updating of PAM, Volume I.

860.1380 Storage Stability

	DER Reference List (Reviewed for PP#s   SEQ CHAPTER \h \r 1 1F6313,
3E6791, 4F6875 & 5E6933):

		  SEQ CHAPTER \h \r 1 46351404; Plant Matrices

		46160103; Tomato Paste

	PPs#1F6313, 3E6791, 4F6875 & 5E6933 Residue Chemistry Memo; D322235; D.
Dotson; 3 				November 2005

ively stable at ≤-20ºC in fortified samples of cabbage (leafy
vegetable), canola seed (oil seed), peach (fruit/fruiting vegetable),
sugar beet roots (root crop), peas (legume vegetable), wheat grain
(non-oily grain), wheat forage (foliage), and wheat straw (dry feed) for
intervals of up to 24 months.  Data are also available indicating that
boscalid is stable for up to 45 days in peanut oil, and for up to 38.4
months in tomato paste stored at ≤-20ºC.  It was noted that the
initial boscalid petition, PP#1F6313, requested storage stability data
on grape processed commodities; this data requirement remains
outstanding.  The storage conditions and durations for coffee green bean
samples are summarized in Table 4, below.

TABLE 4	Summary of Storage Conditions and Durations for Samples from the
Coffee Field Trials.

Crop [Matrix]	Storage Temperature (°C)	Actual Storage Duration (Days)
[Months] 1	Interval of Demonstrated Storage Stability (Months) 2

Coffee

[green bean]	-20 ± 2	409-474

[13.4-15.6]	24

  SEQ CHAPTER \h \r 1 1. Actual storage duration from harvest to
analysis.  Extraction dates were not reported.

2. Based on data from diverse crop matrices (D322235; D. Dotson; 3
November 2005).

	Conclusions:  Adequate storage stability data are available,
demonstrating that residues of boscalid are stable under frozen
conditions in diverse crop matrices for intervals of at least 24 months.
 Samples from the coffee trials were stored for a maximum of about 16
months prior to residue analysis.  There are no storage stability issues
or corrections that need to be applied to the results of residue studies
relevant to the coffee petition.

860.1400 Water, Fish, and Irrigated Crops

	This guideline requirement is not relevant to the current petition, as
there are no aquatic uses being proposed for boscalid.

860.1460 Food Handling

	This guideline requirement is not relevant to the current petition, as
there are no food handling uses being proposed for boscalid.

860.1480 Meat, Milk, Poultry, and Eggs

	There are no significant livestock feedstuffs associated with the
proposed use on coffee.  Therefore, data requirements pertaining to
meat, milk, poultry and eggs are not relevant to this tolerance
petition.

860.1500 Crop Field Trials

	DER Reference List:

		47353903 to -06; Coffee Green Beans

	Four coffee field trials were conducted in Brazil during the 2000
growing season.  At each test location, an untreated plot, and a treated
plot were established, with each plot containing mature coffee trees.
The treated plots received a single foliar broadcast application of the
50% WDG formulation of boscalid at a rate of either 0.134 lb ai/A (0.15
kg ai/ha) or 0.268 lb ai/A (0.30 kg ai/ha).  All applications were made
using ground equipment, in spray volumes of approximately 53 gal/A (500
L/ha), without an adjuvant.  Samples of mature coffee cherries were
harvested 45 days after treatment (BBCH 79-89).  At one site, additional
samples were harvested 0, 15, 30 and 60 days after treatment, in order
to generate residue decline data.  The harvested coffee cherries were
then dried for 10 days, and processed into coffee green beans using a
manual pulper.  The coffee green beans were stored frozen (at roughly
-20°C) for a maximum of 474 days (15.6 months) prior to residue
analysis.  There are adequate storage stability data from previous
boscalid submissions to support the storage conditions and durations of
the coffee bean samples.

	Samples of coffee green beans were analyzed for residues of boscalid
using an HPLC/UV method (BASF Method 441/0).  The validated LOQ was 0.05
ppm for boscalid in coffee green beans.  To verify the adequacy of the
method for data collection, untreated samples of coffee green beans were
fortified with boscalid at levels of 0.05 and 0.50 ppm.  Method
recoveries ranged from 84 to 108%.

	The results (see Table 5, below) indicate that residues of boscalid
were below the method LOQ (<0.05 ppm) in all samples of coffee green
beans harvested 45 days following foliar treatment of coffee crops with
the 50% WDG at 0.134 lb ai/A (2X the maximum proposed rate).  Residues
were also <0.05 ppm in samples treated at the same rate, and collected
at PHIs of 0, 15, 30 and 60 days.  Samples treated at the higher rate of
0.268 lb ai/A contained residues of <0.05-0.08 ppm.

TABLE 5	Summary of Residue Data from Coffee Field Trials with Boscalid.

Crop [Matrix]	Total Use Rate

(lb ai/A) [kg ai/ha]	PHI (Days)	Residue Levels (ppm) 1

	n	Min.	Max.	HAFT 2	Median	Mean	Std. Dev.

Coffee

[green bean]	0.134 [0.150]	45	4	<0.05	<0.05	<0.05	0.05	0.05	0

	0.268 [0.300]	45	3	<0.05	0.08	0.08	0.05	0.06	0.02

1. For calculation of the median, mean, and standard deviation, the LOQ
(0.05 ppm) was used for residues reported 	as <LOQ.

2. HAFT = Highest Average Field Trial.

	Conclusions:  The submitted residue data for coffee are adequate, and
the number of trials performed is consistent with OPPTS Guideline
860.1500 (Crop Field Trials).  Based on the NAFTA Guidance Document on
Data Requirements for Tolerances on Imported Commodities in the United
States and Canada (dated December 2005), 3 trials would be required to
establish a tolerance in imported coffee beans (see Table 6, below).
The amount of coffee available for consumption that is imported is more
than 75%, while the maximum percent of the diet for coffee is less than
0.05%.

	Although the coffee field trial data represent 2X the maximum use rate
specified on the Cantus label, the data will support the proposed use
because residues were nonquantifiable in all samples.  The submitted
data support the proposed RAC tolerance of 0.05 ppm.  However, a revised
Section F should be submitted to correct the commodity definition from
“coffee” to “coffee, green bean.”  The Agency reserves the right
to require additional field trial data, as well as use pattern
information, in the event that boscalid use on coffee grown in countries
other than Brazil is proposed in the future.

Table 6	Coffee Imported to the United States (Five-Year Average,
2003-2007)*

Country	Coffee (1,000 Metric Tons)	% Total Imported	Estimated Number of
Trials

Brazil	288,265	21.6%	0.6

Colombia	235,872	17.6%	0.5

Vietnam	165,010	12.3%	0.4

Guatemala	106,408	8.0%	0.2

Mexico	87,544	6.5%	0.2

Indonesia	83,996	6.3%	0.2

Costa Rica	52,395	3.9%	0.1

Germany	47,711	3.6%	0.1

Peru	47,431	3.5%	0.1

Others	222,286	16.6%	0.5

World 	1,336,916	100.0%	3

* USDA/Economic Research Service Data (last updated 15 March 2008).

860.1520 Processed Food and Feed

	A coffee processing study was not submitted with this petition.  Data
investigating the potential of boscalid residues to concentrate in
roasted coffee beans, and instant coffee, are required.  The study
should be conducted at an exaggerated application rate (5X), in order to
obtain sufficient residue levels for the calculation of processing
factors.

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

	Analytical reference standards for boscalid (with an expiration date of
1 April 2014) are currently available in the EPA National Pesticide
Standards Repository (personal communication with Dallas Wright;
ACB/BEAD; 27 August 2008).  Upon expiration, reference standards for
boscalid should be replenished as requested by the Repository.  The
reference standards should be sent to ACB, located at Fort Meade, to the
attention of either Theresa Cole or Frederic Siegelman, at the address
listed below.

	USEPA

	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

	701 Mapes Road

	Fort George G. Meade, MD   20755-5350

(Please note that the shipment will be returned if the extended zip code
is not used.)

860.1850 and 860.1900 Confined and Field Accumulation in Rotational
Crops

	The requirements for rotational crop data are not relevant to the
current petition because coffee is typically not a rotated crop.  Also,
data for Guidelines 860.1850 and 860.1900 are not required to establish
tolerances in imported commodities.

860.1550 Proposed Tolerances

	HED has determined that the ROC in plants is boscalid per se for the
purposes of risk assessment and tolerance expression (MARC Decision
Memo; D286786; M.J. Nelson; 9 January 2003).  Boscalid tolerances in
plant commodities are listed in 40CFR §180.589[a][1], and are expressed
in terms of residues of the fungicide, boscalid [3-pyridinecarboxamide,
2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl)].  The tolerance expression
proposed by BASF in the current petition is consistent with the
tolerance definition for plant commodities listed in 40CFR
§180.589[a][1].

	The field trial data indicate that residues of boscalid were below the
method LOQ (<0.05 ppm) in all samples of coffee green beans harvested 45
days following foliar treatment of coffee trees with the 50% WDG
formulation, at a rate of 0.134 lb ai/A (2X the proposed maximum
seasonal use rate).  Residues were also <0.05 ppm in samples treated at
the same rate, and collected at PHIs of 0, 15, 30 and 60 days.  Based on
these data, ARIA/RD recommends in favor of establishing the proposed
tolerance for residues of boscalid in the RAC (coffee, green bean) at
0.05 ppm.  However, a revised Section F is required to correct the
commodity definition.  A tolerance summary is presented below, in Table
7.

	The Codex Alimentarius Commission has established an MRL for residues
of boscalid in/on coffee beans at 0.05 ppm, which is in harmony with the
recommended tolerance in imported coffee.  An International Residue
Limit Status Form is appended to this document.

Table 7	Tolerance Summary for Boscalid.

Commodity	Proposed

Tolerance (ppm)	Recommended

Tolerance (ppm)	Comments;

Correct Commodity Definition

Coffee	0.05	0.05	Adequate field trial data are available; Coffee, green
bean

References

	PP#1F06313.  BAS 510 F (Common Name: Boscalid), New Fungicide Active
Ingredient.  Residue Chemistry Summary Document.; D278385, D282532,
D286787, D287829;  SEQ CHAPTER \h \r 1  M.J. Nelson; 15 August 2003.

	PP#s 1F6313, 3E6791, 4F6875, and 5E6933:  Boscalid, Registrant’s
Response to Deficiencies Cited in Tolerance Petition 1F6313.  Summary of
Analytical Chemistry and Residue Data for Rotational Root Crops, Direct
Uses on Celery, Spinach, Bananas, Strawberries, Almonds, and Potatoes,
and Seed Treatment Uses on Bulb Vegetables, Brassica Leafy Vegetables,
Legume Vegetables, Peanuts, and Sunflowers.; D322235;   SEQ CHAPTER \h
\r 1 D. Dotson; 3 November 2005.

	PP# 1F06313.  BAS 510 F in/on Various Plant and Animal Commodities.
HED Metabolism Assessment Review Committee (MARC) Decision Memo.;
D286786; M.J. Nelson; 9 January 2003.

  SEQ CHAPTER \h \r 1 Attachment:  International Residue Limit Status
sheet

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  3-pyridinecarboxamide,
2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl	Common Name:  Boscalid	X
Recommended tolerance

 Re-evaluated tolerance

hS

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 hS

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 h3

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 hY

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dex Status (Maximum Residue Limits)	US Tolerances (Recommended)

 No Codex proposal step 6 or above

 No Codex proposal step 6 or above for the crops requested	Petition
Number:  PP#8E7367

DP Number:  355919

 No Limits

X No Limits for the crops requested	X No Limits

 No Limits for the crops requested

Residue definition:  2-chloro-N-(4'-chloro[1,1'-

biphenyl]-2-yl)-3-pyridinecarboxamide

	Residue definition:  NA 2

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

	Notes:  	1. Per Steve Funk, 26 August 2008.

	2. NA = Not Applicable.

Boscalid	Summary of Analytical Chemistry and Residue Data	D355919

Page   PAGE  12  of   NUMPAGES  12

Page   PAGE  1  of   NUMPAGES  12


[Federal Register Volume 87, Number 205 (Tuesday, October 25, 2022)]
[Notices]
[Page 64509]
[FR Doc No: 2022-23120]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3585-EM; Docket ID FEMA-2022-0001]

South Carolina; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of South Carolina (FEMA-3585-EM), dated
September 29, 2022, and related determinations.

DATES: The declaration was issued September 29, 2022.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 29, 2022, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the State of South Carolina resulting from Hurricane Ian
beginning on September 25, 2022, and continuing, are of sufficient
severity and magnitude to warrant an emergency declaration under the
Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (``the Stafford Act''). Therefore, I declare
that such an emergency exists in the State of South Carolina.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), including direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Kevin A.
Wallace Sr., of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the State of South Carolina have been
designated as adversely affected by this declared emergency:

    Emergency protective measures (Category B), including direct
federal assistance, under the Public Assistance program for all 46
South Carolina counties.

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

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-23120 Filed 10-24-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 158 (Friday, August 15, 2014)]
[Notices]
[Page 48136]
[FR Doc No: 2014-19302]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. DI14-3-000]

Chenega Bay Utilities; Notice of Declaration of Intention and
Soliciting Comments, Protests, and/or Motions To Intervene

    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Declaration of Intention
    b. Docket No: DI14-3-000
    c. Date Filed: June 6, 2014
    d. Applicant: Chenega Bay Utilities
    e. Name of Project: Chenega Hydroelectric Project
    f. Location: The proposed Chenega Hydroelectric Project will be
located on Anderson Creek immediately downstream from the city water
supply dam, near the village of Chenega Bay, Alaska, affecting T. 001S,
R. 008E, S. 23 and 26, Seward Meridian.
    g. Filed Pursuant to: Section 23(b)(1) of the Federal Power Act, 16
USC 817(b) (2012).
    h. Applicant Contact: Charles Totemoff, Chenega Bay Utilities, 3000
C Street, Suite 301, Anchorage, AK 99503; telephone:<PHONE_NUMBER>,
<EMAIL_ADDRESS>mail to<EMAIL_ADDRESS>    i. FERC Contact: Any questions on this notice should be addressed
to Jennifer Polardino,<PHONE_NUMBER>, or Email address:
<EMAIL_ADDRESS>    j. Deadline for filing comments, protests, and/or motions is: 30
days from the issuance of this notice by the Commission.
    Comments, Motions to Intervene, and Protests may be filed
electronically via the Internet. See 18 CFR 385.2001(a)(l)(iii) (2014)
and the instructions on the Commission's Web site under the ``eFiling''
link. If unable to be filed electronically, documents may be paper-
filed. To paper-file, an original and eight copies should be mailed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE., Washington, DC 20426. For more information on how to
submit these types of filings, please go to the Commission's Web site
located at http://www.ferc.gov/filing-comments.asp.
    Please include the docket number (DI14-03-000) on any comments,
protests, and/or motions filed.
    k. Description of Project: The proposed 60-kW run-of-river Chenega
Hydroelectric Project will consist of: (1) An intake chamber, making
use of Anderson Creek (2) a 14-inch-diameter, 1600-foot-long pipe,
which will be buried a minimum of three feet under the existing roadway
and will convey the water from the intake to the powerhouse; (3) a 16
feet by 20 feet powerhouse at an elevation of 64 feet above mean sea
level; (4) a twin-jet Pelton turbine rated at 170 feet of net head
coupled to a generator with an average inflow of 5.4 cfs; (5) a 24-inch
diameter, 40-foot long culvert pipe (6) a 4.5-foot-wide by one-foot-
deep stream channel excavated from the existing ground (7) a screening
box and new constructed spillway; (8) and appurtenant facilities.
    When a Declaration of Intention is filed with the Federal Energy
Regulatory Commission, the Federal Power Act requires the Commission to
investigate and determine if the project would affect the interests of
interstate or foreign commerce. The Commission also determines whether
or not the project: (1) Would be located on a navigable waterway; (2)
would occupy public lands or reservations of the United States; (3)
would utilize surplus water or water power from a government dam; or
(4) would be located on a non-navigable stream over which Congress has
Commerce Clause jurisdiction and would be constructed or enlarged after
1935.
    l. Locations of the Application: Copies of this filing are on file
with the Commission and are available for public inspection. This
filing may be viewed on the web at http://www.ferc.gov using the
``eLibrary'' link. Enter the Docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is also
available for inspection and reproduction at the address in item (h)
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents--All filings must
bear in all capital letters the title ``COMMENTS'', ``PROTESTS'', AND/
OR ``MOTIONS TO INTERVENE'', as applicable, and the Docket Number of
the particular application to which the filing refers. A copy of any
Motion to Intervene must also be served upon each representative of the
Applicant specified in the particular application.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

    Dated: August 7, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-19302 Filed 8-14-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 6, 2007 (Volume 72, Number 234)]
[Notices]
[Page 68950]
[DOCID:fr06de07-122]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Request Revision From the Office of
Management and Budget of a Currently Approved Information Collection
Activity, Request for Comments; FAA Entry Point Filing Form--
International Registry

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget (OMB) to approve a current
information collection. The respondents supply information through the
AC 8050-135 to the FAA Civil Aviation Registry's Aircraft Registration
Branch in order to obtain an authorization code for access to the
International Registry.

DATES: Please submit comments by February 4, 2008.

FOR FURTHER INFORMATION CONTACT: Carla Mauney on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: FAA Entry Point Form--International Registry.
    Type of Request: Extension without change of an approved
collection.
    OMB Control Number: 2120-0697.
    Forms(s): 8050-135.
    Affected Public: A total of 15,000 Respondents.
    Frequency: The information is collected on occasion.
    Estimated Average Burden per Response: Approximately 30 minutes per
response.
    Estimated Annual Burden Hours: An estimated 7,500 hours annually.
    Abstract: The respondents supply information through the AC 8050-
135 to the FAA Civil Aviation Registry's Aircraft Registration Branch
in order to obtain an authorization code for access to the
International Registry.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Mauney, Room 712, Federal Aviation Administration, IT Enterprise
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on November 29, 2007.
Carla Mauney,
FAA Information collection Officer, IT Enterprises Business Services
Division, AES-200.
[FR Doc. 07-5962 Filed 12-5-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register: June 29, 2010 (Volume 75, Number 124)]
[Notices]
[Page 37488]
[DOCID:fr29jn10-106]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act; Notice of Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, July 1,
2010 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Casey, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
July 1, 2010 will be:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Consideration of amicus participation;
An opinion; and
Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: June 24, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-15821 Filed 6-25-10; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 98 (Monday, May 21, 2012)]
[Rules and Regulations]
[Pages 29866-29867]
[FR Doc No: 2012-12165]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0847; Airspace Docket No. 11-ASW-11]

Amendment of Class E Airspace; Springhill, LA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class E airspace for Springhill, LA.
Decommissioning of the Springhill non-directional beacon (NDB) at
Springhill Airport has made this action necessary to enhance the safety
and management of Instrument Flight Rule (IFR) operations at the
airport. The geographic coordinates of the airport also are adjusted.

DATES: Effective date: 0901 UTC, July 26, 2012. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On January 31, 2012, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace for Springhill,
LA, reconfiguring controlled airspace at Springhill Airport (77 FR
4707) Docket

No. FAA-2011-0847. Interested parties were invited to participate in
this rulemaking effort by submitting written comments on the proposal
to the FAA. No comments were received. Class E airspace designations
are published in paragraph 6005 of FAA Order 7400.9V dated August 9,
2011, and effective September 15, 2011, which is incorporated by
reference in 14 CFR 71.1. The Class E airspace designations listed in
this document will be published subsequently in the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace extending upward from 700 feet
above the surface for the Springhill, LA area. Decommissioning of the
Springhill NDB and cancellation of the NDB approach at Springhill
Airport has made reconfiguration of the airspace necessary for the
safety and management of IFR operations at the airport. Geographic
coordinates are updated to coincide with the FAA's aeronautical
database.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Springhill Airport, Springhill, LA.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

0
1. The authority citation for 14 CFR Part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective September 15,
2011 is amended as follows:
* * * * *

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

ASW LA E5 Springhill, LA [Amended]

Springhill Airport, LA
    (Lat. 32[deg]59'00'' N., long. 93[deg]24'33'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Springhill Airport.

    Issued in Fort Worth, Texas, on May 11, 2012.
Walter L. Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2012-12165 Filed 5-18-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 837-838]
[FR Doc No: 2019-00497]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84981; File No. SR-PHLX-2018-72]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To Establish Rules Governing the Give Up of a Clearing Member by
a Member Organization on Exchange Transactions

January 9, 2019.
    On November 6, 2018, Nasdaq PHLX LLC filed with the Securities and
Exchange Commission (``Commission''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a

proposed rule change to establish rules governing the give up of a
Clearing Member by a member organization on Exchange transactions. The
proposed rule change was published for comment in the Federal Register
on November 26, 2018.\3\ The Commission has received three comment
letters regarding the proposed rule change.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 84624 (November 19,
2018), 83 FR 60547.
    \4\ See letters to Brent J. Fields, Secretary Commission, from
Matthew R. Scott, President, Merrill Lynch Professional Clearing
Corp., dated December 7, 2018; Ellen Greene, Managing Director,
Capital Markets, SIFMA, dated December 17, 2018; and John P.
Davidson, President and Chief Operating Officer, The Options
Clearing Corporation, dated December 19, 2018.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ provides that, within 45 days of
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it find such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is January 10, 2019. The Commission is extending this 45-day time
period.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change. Accordingly, the
Commission pursuant to Section 19(b)(2) of the Act,\6\ designates
February 24, 2019, as the date by which the Commission shall either
approve or disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-PHLX-2018-72).
---------------------------------------------------------------------------

    \6\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2019-00497 Filed 1-30-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 184 (Tuesday, September 22, 2020)]
[Notices]
[Pages 59574-59576]
[FR Doc No: 2020-20839]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89897; File No. SR-NASDAQ-2020-062]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing of Proposed Rule Change To Amend Listing Rules
Applicable to Special Purpose Acquisition Companies Whose Business Plan
Is To Complete One or More Business Combinations

September 16, 2020.
    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 September 3, 2020, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III 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

    The Exchange proposes to amend listing rules applicable to
companies whose business plan is to complete one or more business
combinations.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/nasdaq/rules, at
the principal office of the Exchange, 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 these 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 aspects of such
statements.

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

1. Purpose
    In 2009, Nasdaq adopted additional listing requirements for a
company whose business plan is to complete an initial public offering
and engage in a merger or acquisition with one or more unidentified
companies within a specific period of time (``Acquisition
Companies'').\3\ Such a company is required to keep at least 90% of the
proceeds from its initial public offering in an escrow account and,
until the company has completed one or more business combinations
having an aggregate fair market value of at least 80% of the value of
the escrow account, must meet the requirements for initial listing
following each business combination.\4\ If a shareholder vote on the
business combination is held, public shareholders voting against a
business combination must have the right to convert their shares of
common stock into a pro rata share of the aggregate amount then in the
escrow account (net of taxes payable and amounts distributed to
management for working capital purposes) if the business combination is
approved and consummated.\5\ If the combined company does not meet the
initial listing requirements following a business combination, Nasdaq
Staff will

issue a Staff Delisting Determination under Nasdaq Rule 5810.
---------------------------------------------------------------------------

    \3\ Securities Exchange Act Release No. 58228 (July 25, 2008),
73 FR 44794 (July 31, 2008) (adopting the predecessor to IM-5101-2).
    \4\ See Nasdaq Rule IM-5101-2(d) and (e) [sic].
    \5\ See Nasdaq Rule IM-5101-2(d). If a shareholder vote on the
business combination is not held, the company must provide all
shareholders with the opportunity to redeem their shares for cash
equal to their pro rata share of the aggregate amount then in the
deposit account (net of taxes payable and amounts distributed to
management for working capital purposes). Nasdaq Rule IM-5101-2(e).
---------------------------------------------------------------------------

    Under the existing rules, ``following each business combination''
with an Acquisition Company, the resulting company must satisfy all
initial listing requirements. The rule does not provide a timetable for
the company to demonstrate that it satisfies those requirements,
however. Accordingly, Nasdaq proposes to modify the rule to specify if
the Acquisition Company demonstrates that it will satisfy all
requirements except the applicable round lot shareholder requirement,
then the company will receive 15 calendar days following the closing to
demonstrate that it satisfied the applicable round lot shareholder
requirement immediately following the transaction's closing.
    Ordinarily, in determining compliance with the round lot
shareholder requirement at the time of a business combination, Nasdaq
will review a company's public disclosures and information provided by
the company about the transaction. For example, the merger agreement
may result in the Acquisition Company issuing a round lot of shares to
more than 300 holders of the target of the business combination at
closing. If public information is not available that enables Nasdaq to
determine compliance, Nasdaq will typically request that the company
provide additional information such as registered shareholder lists
from the company's transfer agent, data from Cede & Co. about shares
held in street name, or data from broker-dealers and from third parties
that distribute information such as proxy materials for the broker-
dealers.\6\ If the company can provide information demonstrating
compliance before the business combination closes, no further
information would be required.
---------------------------------------------------------------------------

    \6\ Companies must seek this information from third parties
because many accounts are held in street name and shareholders may
object to being identified to the company.
---------------------------------------------------------------------------

    However, Nasdaq has observed that in some cases it can be difficult
for a company to obtain evidence demonstrating the number of
shareholders that it has or will have following a business combination.
As noted above, shareholders of an Acquisition Company may redeem or
tender their shares until just before the time of the business
combination, and the company may not know how many shareholders will
choose to redeem until very close to the consummation of the business
combination. In cases where the number of round lot shareholders is
close to the applicable requirement, this could affect the ability for
Nasdaq to determine compliance before the business combination closes.
Accordingly, for a company that has demonstrated that it will satisfy
all initial listing requirements except for the round lot shareholder
requirement before consummating the business combination, Nasdaq will
allow the company 15 calendar days after the closing of the business
combination, if necessary, to demonstrate that it also complied with
the round lot requirement at the time of the business combination. To
be clear, the company must still demonstrate that it satisfied the
round lot shareholder requirement immediately following the business
combination; the proposal is merely giving the company 15 calendars
days to provide evidence that it did.
    Nasdaq believes that this proposal balances the burden placed on
the Acquisition Company to obtain accurate shareholder information for
the new entity and the need to ensure that a company that does not
satisfy the initial listing requirements following a business
combination enters the delisting process promptly. If the company does
not evidence compliance within the proposed time period, Nasdaq staff
would issue a delisting determination, which the company could appeal
to an independent Hearings Panel as described in the 5800 Series of the
Nasdaq Rules.
    Finally, Nasdaq proposes a non-substantive change to eliminate a
duplicate paragraph in paragraphs (d) and (e) of IM-5101-2 and to add a
new paragraph designation.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\7\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\8\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest,
by imposing a specific timeline for Acquisition Companies to
demonstrate that they will comply with the initial listing requirements
following a business combination and allowing a reasonable period of
time for the company to provide evidence that it complied with the
round lot shareholder requirement at the time of the business
combination.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The proposed rule would specify the time when an Acquisition
Company must demonstrate compliance with the initial listing standards
following the completion of a business combination, thereby enhancing
investor protection. Specifically, it would require an Acquisition
Company to provide evidence before completing the business combination
that it will satisfy all requirements for initial listing, except for
the round lot shareholder requirement. While the proposed rule would
allow Acquisition Companies 15 calendar days, if needed, to provide
evidence that they also complied with the round lot shareholder
requirement at the time of the business combination, that additional
time is a reasonable accommodation given both the difficulty companies
face in identifying their shareholders and the ability for the
Acquisition Company's shareholders to redeem their shares when the
business combination is consummated. In that regard, Acquisition
Companies are unlike other newly listing companies, which do not face
redemptions and are not already listed and trading at the time they
must demonstrate compliance. Importantly, the company must still
demonstrate that it satisfied the round lot shareholder requirement
immediately following the business combination. As such, Nasdaq
believes that the proposed rule change appropriately balances the
protection of prospective investors with the protection of shareholders
of the Acquisition Company, the latter of whom would be harmed if
Nasdaq issued a delisting determination at a time when the company did,
in fact, satisfy all initial listing requirements but could not yet
provide proof.
    The proposed rule change is also consistent with Section 6(b)(7) of
the Act in that it provides a fair procedure for the prohibition or
limitation by the Exchange of any person with respect to access to
services offered. The proposed rule change accounts for the particular
difficulties encountered by Acquisition Companies when attempting to
determine their total number of shareholders due to the ability of
shareholders to redeem their shares. Acquisition Companies will still
be required to demonstrate compliance with all initial listing
standards immediately following the business combination, which is the
initial listing of the combined company. This is no different from the
requirements imposed on other newly listing companies.
    The non-substantive changes to eliminate a duplicate paragraph in

paragraphs (d) and (e) of IM-5101-2 and to add a new paragraph
designation will improve the rule's readability and thereby remove an
impediment to a free and open market and a national market system and
help to better protect investors, which Nasdaq believes is consistent
with the requirements of Section 6(b)(5) of the Act.\9\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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. The proposed rule would clarify
that a company listing in connection with a merger with an Acquisition
Company must provide evidence before completing the business
combination that it will satisfy all requirements for initial listing,
although a reasonable accommodation would be made to allow the company
to demonstrate compliance with the round lot shareholder requirement
before issuing a delisting letter if that is the only requirement that
the company cannot demonstrate compliance with before completing the
business combination. This change is not expected to have any impact on
competition.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

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-2020-062 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2020-062. 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 website (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 website 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 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NASDAQ-2020-062, and should be submitted
on or before October 13, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-20839 Filed 9-21-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 1, 2010 (Volume 75, Number 210)]
[Notices]
[Page 67088-67090]
[DOCID:fr01no10-26]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0818; FRL-9218-6]

Clean Water Act (CWA) and Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) Common Aquatic Life Effects Assessment for
Pesticides Using Available Data

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of national meeting and request for public comment.

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

SUMMARY: EPA will conduct a national stakeholders meeting to solicit
input on methods being evaluated by the Office of Pesticide Programs
(OPP) and the Office of Water (OW), with the support of the Office of
Research and Development (ORD) to develop common characterizations of
effects from pesticides on fish, other aquatic organisms, and aquatic
plants in aquatic ecosystems. The national meeting will be held in
Washington, DC, December 1, 2010. EPA has developed a set of draft
white papers that explore: (1) The use of various tools to estimate
aquatic toxicity data; (2) approaches for deriving community level
benchmarks; and (3) procedures for better integrating plant effects
data into community level assessments. EPA is soliciting stakeholder
input on the tools and approaches presented in the draft white papers
via public comment and at the national meeting.

DATES: The national stakeholders meeting will be held December 1, 2010;
the agency must receive written requests (via e-mail or US Mail to one
of the points of contact listed below) to deliver verbal comments at
the National Stakeholder prior to the meeting on December 1, 2010.
Written comments may be submitted to the docket (see instructions
below) anytime between November 1, 2010 and prior to the close of the
docket on January 15, 2010.

ADDRESSES: EPA will hold a national stakeholders meeting at the
following address: USEPA East (EPA East) [Old ICC Building], 1201
Constitution Avenue, NW., Washington, DC 20004, Room  1153 EPA
East.
    To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.
    You may submit comments, identified by the Docket ID: EPA-HQ-OW-
2010-0818, by any of the following methods:
     Federal Rulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Agency Web Site<EMAIL_ADDRESS>Follow the instructions
for submitting comments on the<EMAIL_ADDRESS>     E-mail<EMAIL_ADDRESS>Include EPA-HQ-OW-2010-0818 in
the subject line of the message.
     Mail: US Environmental Protection Agency, EPA Docket
Center (EPA/DC) Water Docket, MC 4101T,1200

Pennsylvania Avenue, NW., Washington, DC 20460
     Hand Delivery/Courier: Public Reading Room, Room B102, EPA
West Building, 1301 Constitution Avenue, NW., Washington, DC. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.

FOR FURTHER INFORMATION CONTACT: Joseph Beaman, Health and Ecological
Criteria Division (4304T), Office of Water, U.S. EPA, 1200 Pennsylvania
Ave., NW., Washington, DC 20460;<PHONE_NUMBER><EMAIL_ADDRESS>    Mark Corbin, Environmental Fate and Effects Division (7507P),
Office of Pesticide Programs, U.S. EPA, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460;<PHONE_NUMBER><EMAIL_ADDRESS>    Cindy Roberts, Office of Science Policy (8104R), Office of Research
and Development, U.S. EPA, 1200 Pennsylvania Ave., NW., Washington, DC
20460;<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

    A. Instructions: All submissions received must include the agency
name and docket number for this notice. All comments received will be
posted without change to www.regulations.gov, including any personal
information provided.
    B. Meeting: This meeting is open to the public; registration is not
required for attending this meeting. Seats will be available on a first
come, first served basis.
    C. Does this Action Apply to Me? This action is directed to the
public in general, and may be of interest to a wide range of
stakeholders, including environmental, water resources professionals,
and agricultural advocates, the chemical industry, pesticide users, and
members of the public interested in the sale, distribution, or use of
pesticides. Since others also may be interested, the Agency has not
attempted to describe all the specific entities that may be affected by
this action. If you have any questions regarding the applicability of
this action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
    D. How Can I Get Copies of this Document and Other Related
Information? EPA has established a docket for this action under docket
ID number EPA-HQ-OW-2010-0818. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the Office
of Water's (OW) Public Reading Room, Room B102, EPA West Building, 1301
Constitution Avenue, NW., Washington, DC. The hours of operation of
this Docket Facility are from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The Docket Facility telephone number
is<PHONE_NUMBER>.
    Alternatively, the documents for this meeting as well as materials
related to this action that have been previously developed can be found
on the EPA Web site: Office of Water link: http://www.epa.gov/
waterscience/criteria/aqlife/cem.html Office of Pesticide Programs
link: http://www.epa.gov/oppefed1/cwa_fifra_effects_methodology/.

II. Background

    Section 304(a)(1) of the Clean Water Act (CWA) requires EPA to
develop, publish, and from time to time, revise criteria for water
quality that accurately reflect the latest scientific knowledge. Water
quality criteria are scientifically derived numeric values that measure
the level beyond which pollutants in ambient water are expected to have
deleterious effects on aquatic life or human health. Water quality
criteria developed under Section 304(a) are based solely on data and
scientific judgments on the relationship between pollutant
concentrations and environmental and human health effects. Section
304(a) criteria do not reflect consideration of economic impacts or the
technological feasibility of meeting the chemical concentrations in
ambient water.
    Section 304(a) criteria provide guidance to states and authorized
tribes in adopting water quality standards that ultimately provide the
basis for controlling discharges or releases of pollutants. The
criteria also provide guidance to EPA when promulgating federal
regulations under Section 303(c), when such action is necessary. Under
the CWA and its implementing regulations, states and authorized tribes
adopt water quality criteria to support designated uses (e.g., aquatic
life, public water supply, recreational use). EPA's recommended
criteria do not impose legally binding requirements. States and
authorized tribes have the discretion to adopt, where appropriate,
other water quality criteria based on scientifically defensible
approaches that differ from EPA's recommended criteria.
    FIFRA requires that all pesticides used in the U.S. be registered
by EPA and thus ensures federal control of distribution, sale, and use
of pesticides. Registration assures that pesticides will be properly
labeled and that, if used in accordance with labeled specifications,
will not cause unreasonable adverse effects on human health and the
environment. FIFRA ecological risk assessments quantitatively evaluate
reduced survival of aquatic animals from direct acute exposures and
survival, growth, and reproductive impairment for aquatic animals from
direct chronic exposures. Assessments for aquatic plants focus on
growth rates and biomass (reproduction) measurements. Effects
assessments are an important component of a FIFRA risk assessment.
    For FIFRA ecological effects assessments, EPA reviews toxicity data
provided by the registrant as required by regulation, as well as data
from public sources obtained from EPA's ECOTOX database. Current
testing requirements for aquatic organisms include toxicity studies
containing information on survival, reproduction, and growth endpoints
for freshwater and estuarine/marine animals and biomass and growth
endpoints for aquatic plants. These test requirements are defined for
each chemical class by use category in title 40 of the Code of Federal
Regulations, Part 158. Studies are performed on laboratory test
organisms in the following broad taxonomic groupings: freshwater fish
and invertebrates, estuarine/marine fish and invertebrates, and aquatic
plants. For screening-level assessments, OPP's effects assessments are
based on the lowest acute and chronic toxicity values from the most
sensitive species tested in acceptable studies. More refined
assessments may use the full species sensitivity distribution for a
given taxon or other toxicity endpoints, as for the variability and
uncertainty of the data (probabilistic approaches). The ``OPP Aquatic
Benchmarks'' is a web site developed by OPP that contains the aquatic
toxicity endpoints used in EPA pesticide risk assessments. (http://
www.epa.gov/oppefed1/ecorisk_ders/aquatic_life_benchmarks.htm).
    OPP toxicity benchmarks and OW AWQC are both developed with high
quality data pursuant to parallel but somewhat different rigorously
peer-reviewed assessment methodologies. The opportunity being addressed
by EPA is how best to build on the substantial high quality science
developed under both programs to develop a consistent and common set of
effects characterization methods that integrates these approaches for
regulators to use in different programs at both the Federal and State
level. Stakeholders have identified a need for

consistent and timely federal input that will allow EPA, states,
tribes, and the public to gauge whether pesticides represent a concern
for aquatic life, for example, based on water monitoring results. To
address these concerns, the Agency has begun a process to explore how
to build on the high quality science in both OW and OPP to develop
additional tools and approaches to support consistent and common
effects characterizations using the best available information. If
successful, this common tiered effects characterization methodology and
resultant advisory values would allow Federal and State risk managers
to make environmentally protective and scientifically defensible,
timely decisions about chemicals that may be found in ambient water in
a consistent manner while meeting the mandates of both CWA and FIFRA.
    A scoping document was published in April 2009, http://www.epa.gov/
oppefed1/cwa_fifra_effects_methodology/scope.html that described
this effort in more detail and invited public participation in our
collective efforts. Following through on this invitation, 6 regional
stakeholders meetings where held in January 2010. The feedback received
from stakeholders assisted EPA in crafting three draft white papers.
Now, a national stakeholders meeting is being planned for October 29,
2010 to solicit input on the Agency's draft white papers that address
the following topics:
    (1) The use of various tools to estimate aquatic toxicity data;
    (2) approaches for deriving community level benchmarks; and
    (3) procedures for better integrating plant effects data into
community level assessments.
    These white papers also describe how the potential new tools,
methods, and analytical approaches that may be used by the Agency,
state pesticide and water quality agencies, and other stakeholders to
gauge whether pesticides represent a concern for aquatic life.
Following this meeting, the Agency plans to revise the white papers,
based on public comments and feedback from the stakeholders. The white
papers will then be reviewed by EPA's Science Advisory Board in summer
2011.
    For more information about water quality criteria and Water Quality
Standards, refer to the following: Water Quality Standards Handbook
(EPA 823-B94-005a); Advanced Notice of Proposed Rule Making (ANPRM),
(63 FR 36742); Water Quality Criteria and Standards Plan--Priorities
for the Future (EPA 822-R-98-003); Guidelines and Methodologies Used in
the Preparation of Health Effects Assessment Chapters of the Consent
Decree Water Criteria Documents (45 FR 79347); Methodology for Deriving
Ambient Water Quality Criteria for the Protection of Human Health
(2000), EPA-822-B-00-004); Guidelines for Deriving Numerical National
Water Quality Criteria for the Protection of Aquatic Organisms and
Their Uses (EPA 822/R-85-100); National Strategy for the Development of
Regional Nutrient Criteria (EPA 822-R-98-002); and EPA Review and
Approval of State and Tribal Water Quality Standards (65 FR 24641). You
can find these publications through EPA's National Service Center for
Environmental Publications (NSCEP, previously NCEPI) or on the Office
of Science and Technology's home page (http://www.epa.gov/
waterscience).
    For more information about the OPP Ecological Exposure Assessment
Process under FIFRA, refer to the following: Overview of the Ecological
Risk Assessment Process in the Office of Pesticide Programs, which
describes how pesticide data are used in ecological risk assessments
(http://www.epa.gov/oppfead1/endanger/consultation/ecorisk-
overview.pdf). The data requirements for aquatic non-target plants and
animals for pesticides are described in title 40 of the Code of Federal
Regulations, revised July 1, 2008 (158.660 Non-target Plant Protection
Data Requirements). The required procedures for conducting the studies
are described in OPPTS Harmonized Test Guidelines. Series 850
Ecological Effects Test Guidelines--Public Drafts (http://www.epa.gov/
opptsfrs/publications/OPPTS_Harmonized/850_Ecological_Effects_
Test_Guidelines/Drafts/). Information on procedures used to evaluate
these studies are described in: Standard Evaluation Protocols, the
guidance document entitled the Rejection Rate Analysis: Ecological
Effects (EPA 738-R-94-035), and in the OPP Overview Document. Public
literature is accessed by OPP through EPA's ECOTOX database (http://
cfpub.epa.gov.ecotox/). The ``OPP Aquatic Benchmarks,'' a Web site
developed by OPP, contains the aquatic toxicity endpoints used in
pesticide assessments (http://www.epa.gov/oppefed1ecorisk_ders/
aquatic_life_benchmarks.htm).

III. What type of comments does EPA want to receive?

    EPA would like the public to comment on the following:
    1. The data, tools, and methods presented in the white papers;
    2. Alternate tools or methods that EPA should consider for
extrapolating or estimating aquatic toxicity data;
    3. Alternate methods EPA should consider for developing community
level benchmarks or aquatic life screening values when minimum data
requirements for national recommended aquatic life criteria are not
met;
    4. The types of values that are used by states and/or regions for
protecting aquatic life in the absence of ambient water quality
criteria; and
    5. Approaches to establishing plant-based criteria, or methods to
better incorporate plant effects data in community level benchmarks.

    Dated: September 27, 2010.
Ephraim S. King,
Director, Office of Science and Technology, Office of Water.
    Dated: September 29, 2010.
Steve Bradbury,
Director, Office of Pesticide Programs.
    Dated: September 29, 2010.
Fred Hauchman,
Director, Office of Science Policy, Office of Research and Development.
[FR Doc. 2010-27289 Filed 10-27-10; 8:45 am]
BILLING CODE 6560-50-P