[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Page 10201]
[FR Doc No: 2015-03873]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Revonergy Inc., Siberian Energy Group Inc., Tao
Minerals Ltd., (n/k/a Canam Gold Corp.), and Todays Alternative Energy
Corp.; Order of Suspension of Trading

February 20, 2015.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Revonergy Inc. because it has not filed any periodic reports since the
period ended September 30, 2011.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Siberian Energy Group Inc. because it has not filed any periodic
reports since the period ended June 30, 2012.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Tao Minerals Ltd. (n/k/a Canam Gold Corp.) because it has not filed any
periodic reports since the period ended October 31, 2011.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Todays Alternative Energy Corp. because it has not filed any periodic
reports since the period ended July 31, 2012.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed companies is suspended for the period from 9:30 a.m. EST
on February 20, 2015, through 11:59 p.m. EST on March 5, 2015.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-03873 Filed 2-24-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Proposed Rules]
[Pages 50713-50714]
[FR Doc No: 2011-20763]

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

Coast Guard

46 CFR Part 401

[USCG-2011-0328]
RIN 1625-AB70

2012 Rates for Pilotage on the Great Lakes

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking; correction.

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SUMMARY: This document corrects the preamble to a proposed rule
published in the Federal Register of August 4, 2011, concerning rates
for pilotage on the Great Lakes. This correction provides four rows
that were missing from Table 36 in the earlier document and corrects a
misspelled column heading in Table 37 of that document.

FOR FURTHER INFORMATION CONTACT: For questions on this notice contact
Mr. Todd Haviland, Management & Program Analyst, Office of Great Lakes
Pilotage, Commandant (CG-5522), Coast Guard; telephone<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>or fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Correction

    In proposed rule FR Doc. 2011-19746, on page 47109 in the issue of
August 4, 2011, the second column heading in Table 37 should read
``Table Multiplier.'' Also on that page, correct Table 36 to read as
follows:

                     Table 36--Proposed Adjustment of Pilotage Rates, Areas in District Two
----------------------------------------------------------------------------------------------------------------
                                                                            Rate                   Adjusted rate
                                               2011 Rate                 multiplier                  for 2012
----------------------------------------------------------------------------------------------------------------
Area 4--Lake Erie:
    6 hour period.........................            $791          x           0.964          =            $762
    Docking or undocking..................             609          x           0.964          =             587
    Any point on Niagara River below Black           1,554          x           0.964          =           1,497
     Rock Lock............................
Area 5--Southeast Shoal to Port Huron, MI
 between any point on or in:
    Toledo or any point on Lake Erie W. of           1,412          x           0.972          =           1,372
     Southeast Shoal......................
    Toledo or any point on Lake Erie W. of           2,389          x           0.972          =           2,231
     Southeast Shoal & Southeast Shoal....
    Toledo or any point on Lake Erie W. of           3,102          x           0.972          =           3,014
     Southeast Shoal & Detroit River......
    Toledo or any point on Lake Erie W. of           2,389          x           0.972          =           2,321
     Southeast Shoal & Detroit Pilot Boat.
    Port Huron Change Point & Southeast              4,162          x           0.972          =           4,044
     Shoal (when pilots are not changed at
     the Detroit Pilot Boat)..............
    Port Huron Change Point & Toledo or              4,821          x           0.972          =           4,684
     any point on Lake Erie W. of
     Southeast Shoal (when pilots are not
     changed at the Detroit Pilot Boat)...
    Port Huron Change Point & Detroit                3,126          x           0.972          =           3,037
     River................................
    Port Huron Change Point & Detroit                2,432          x           0.972          =           2,363
     Pilot Boat...........................
    Port Huron Change Point & St. Clair              1,729          x           0.972          =           1,680
     River................................
    St. Clair River.......................           1,412          x           0.972          =           1,372
    St. Clair River & Southeast Shoal                4,162          x           0.972          =           4,044
     (when pilots are not changed at the
     Detroit Pilot Boat)..................
    St. Clair River & Detroit River/                 3,126          x           0.972          =           3,037
     Detroit Pilot Boat...................
    Detroit, Windsor, or Detroit River....           1,412          x           0.972          =           1,372
    Detroit, Windsor, or Detroit River &             2,389          x           0.972          =           2,321
     Southeast Shoal......................
    Detroit, Windsor, or Detroit River &             3,102          x           0.972          =           3,014
     Toledo or any point on Lake Erie W.
     of Southeast Shoal...................
    Detroit, Windsor, or Detroit River &             3,126          x           0.972          =           3,037
     St. Clair River......................
    Detroit Pilot Boat & Southeast Shoal..           1,729          x           0.972          =           1,680
    Detroit Pilot Boat & Toledo or any               2,389          x           0.972          =           2,321
     point on Lake Erie W. of Southeast
     Shoal................................
    Detroit Pilot Boat & St. Clair River..           3,126          x           0.972          =           3,037
----------------------------------------------------------------------------------------------------------------

    Dated: August 10, 2011.
Kathryn Sinniger,
Chief, Office of Regulations and Administrative Law, United States
Coast Guard.
[FR Doc. 2011-20763 Filed 8-15-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 75, Number 238 (Monday, December 13, 2010)]
[Notices]
[Pages 77645-77647]
[FR Doc No: 2010-31195]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0622]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Color Additive Certification Requests and
Recordkeeping

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of FDA's regulations governing batch certification of color
additives manufactured for use in foods, drugs, cosmetics or medical
devices in the United States.

DATES: Submit either electronic or written comments on the collection
of information by February 11, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://

www.regulations.gov. Submit written comments on the collection of
information to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
All comments should be identified with the docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Color Additive Certification Requests and Recordkeeping--21 CFR Part 80
(OMB Control Number 0910-0216)--Extension

    FDA has regulatory oversight for color additives used in foods,
drugs, cosmetics, and medical devices. Section 721(a) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379e(a))
provides that a color additive shall be deemed to be unsafe unless it
meets the requirements of a listing regulation, including any
requirement for batch certification, and is used in accordance with the
regulation. FDA lists color additives that have been shown to be safe
for their intended uses in title 21 of the Code of Federal Regulations
(CFR). FDA requires batch certification for all color additives listed
in 21 CFR part 74 and for all color additives provisionally listed in
21 CFR part 82. Color additives listed in 21 CFR part 73 are exempted
from certification.
    The requirements for color additive certification are described in
part 80 (21 CFR part 80). In the certification procedure, a
representative sample of a new batch of color additive, accompanied by
a ``request for certification'' that provides information about the
batch, must be submitted to FDA's Office of Cosmetics and Colors. FDA
personnel perform chemical and other analyses of the representative
sample and, providing the sample satisfies all certification
requirements, issue a certification lot number for the batch. FDA
charges a fee for certification based on the batch weight and requires
manufacturers to keep records of the batch pending and after
certification.
    Under Sec.  80.21, a request for certification must include: Name
of color additive, manufacturer's batch number and weight in pounds,
name and address of manufacturer, storage conditions, statement of
use(s), certification fee, and signature of person requesting
certification. Under Sec.  80.22, a request for certification must
include a sample of the batch of color additive that is the subject of
the request. The sample must be labeled to show: Name of color
additive, manufacturer's batch number and quantity, and name and
address of person requesting certification. Under Sec.  80.39, the
person to whom a certificate is issued must keep complete records
showing the disposal of all of the color additive covered by the
certificate. Such records are to be made available upon request to any
accredited representative of FDA until at least 2 years after disposal
of all of the color additive.
    The purpose for collecting this information is to help FDA assure
that only safe color additives will be used in foods, drugs, cosmetics,
and medical devices sold in the United States. The required information
is unique to the batch of color additive that is the subject of a
request for certification. The manufacturer's batch number is used for
temporarily identifying a batch of color additive until FDA issues a
certification lot number and for identifying a certified batch during
inspections. The manufacturer's batch number also aids in tracing the
disposal of a certified batch or a batch that has been denied
certification for noncompliance with the color additive regulations.
The manufacturer's batch weight is used for assessing the certification
fee. The batch weight also is used to account for the disposal of a
batch of certified or certification-denied color additive. The batch
weight can be used in a recall to determine whether all unused color
additive in the batch has been recalled. The manufacturer's name and
address and the name and address of the person requesting certification
are used to contact the person responsible should a question arise
concerning compliance with the color additive regulations. Information
on storage conditions pending certification is used to evaluate whether
a batch of certified color additive is inadvertently or intentionally
altered in a manner that would make the sample submitted for
certification analysis unrepresentative of the batch. FDA checks
storage information during inspections. Information on intended uses
for a batch of color additive is used to assure that a batch of
certified color additive will be used in accordance with the
requirements of its listing regulation. The statement of the fee on a
certification request is used for accounting purposes so that a person
requesting certification can be notified promptly of any discrepancies.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section              Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
80.21...........................              32             185           5,920            0.17           1,006

80.22...........................              32             185           5,920            0.05             296
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,302
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                Table 2--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section              Number of     frequency of    Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
----------------------------------------------------------------------------------------------------------------
80.39...........................              32             185           5,920            0.25           1,480
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,480
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA bases its estimate on its review of the certification requests
received over the past 3 fiscal years (FY). The annual burden estimate
for this information collection is 2,782 hours. The estimated reporting
burden for this information collection is 1,302 hours and the estimated
recordkeeping burden for this information collection is 1,480 hours.
From FY 2008 to FY 2010, FDA processed an average of 5,932 responses
(requests for certification of batches of color additives) per year.
There were 32 different respondents, corresponding to an average of
approximately 185 responses from each respondent per year. Using
information from industry personnel, FDA estimates that an average of
0.22 hour per response is required for reporting (preparing
certification requests and accompanying samples) and an average of 0.25
hour per response is required for recordkeeping.
    FDA's Web-based color certification information system allows
certifiers to request color certification online, follow their
submissions through the process, and obtain information on account
status. The system sends back the certification results electronically,
allowing certifiers to sell their certified color before receiving hard
copy certificates. Any delays in the system result only from shipment
of color additive samples to FDA's Office of Cosmetics and Colors for
analysis. FDA has estimated a reduction in the hour burden for
reporting from use of the Web-based system.

    Dated: December 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31195 Filed 12-10-10; 8:45 am]
BILLING CODE 4160-01-P


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

Date:		October 21, 2008

Subject:  	Metolachlor:  Metolachlor Residue Chemistry Data For Crop Subgroup

6-b Commodities; and a Field Accumulation in Rotational Crops Study with Metolachlor Using Oats and Wheat.

PC Code: 108800	DP Barcodes:   D336373/D348268

MRID Nos.:  47015301, 47312501	Registration No.: Numerous

Petition No.: N/A 	Regulatory Action: Section 3

Assessment Type:  N/A                    	Reregistration Case No.: 0001

TXR No.: None	CAS No.:  51218-45-2

Decision #s:  348979/388477

From:		Dennis McNeilly, Chemist

RAB2, Health Effects Division, (7509P)

Through:  	    Douglas Dotson, Ph.D., Chemist

		RAB2, Health Effects Division (7509P)

			And

Michael Doherty, Ph.D., Senior Chemist

		RAB2, Health Effects Division (7509P)

TO:		Eugene Wilson/Joanne Miller, RM 23

Herbicide Branch, Registration Division (7505P)

				and

		Michael Goodis, RM53

Special Review and Reregistration Division (7508P)

The Metolachlor Task Force sponsored field trial data for metolachlor on Crop

Subgroup 6-b commodities (MRID 47015301) to fulfill a data gap identified in the Metolachlor RED and TRED (TRED for Metolachlor and S-Metolachlor, D292881, S. Kinard, 8/15/03.  Five field trials were conducted in the United States using succulent beans (four trials) and succulent peas (one trial) during the 2005 growing season.  The field trials with beans encompassed EPA Growing Zones 1, 2, and 3, while the field trial with peas was in Zone 1.  Treated plots received one pre-plant incorporated (PPI) application at a nominal application rate of 1.33 lb ai/A for coarse soils or 1.67 lb ai/A for medium soils.  Pre-harvest intervals (PHIs) ranged from 51 to 69 days for peas, beans, and forage, and from 54 to 76 days for hay.

The Metolachlor Task Force also submitted a field accumulation in rotational crops study using metolachlor (MRID 47312501) in response to a 2004 data call-in (DCI).  Two rotational crop studies were conducted using oat and wheat as the rotational crops during the 2006-2007 growing season in CA and GA.  At both sites, the first application was made at a target rate of 1.33 lb ai/A/application and the second was made at a rate of 1.67 lb ai/A/ application, with a 41- to 95-day retreatment interval, for a  total seasonal rate of 3.0 lb ai/A.

Executive Summary

Metolachlor is a selective, chloroacetanilide herbicide that is applied to a variety of crops as a preplant, preplant-incorporated (PPI), pre-emergence, or post-emergence-directed application (Note: there is no post-emergence application for Crop Group 6 commodities), primarily for the control of grass weeds.  Metolachlor is registered for use on a wide variety of crops including: corn, cotton, grasses grown for seed, legume vegetables, peanuts, potatoes, safflower, sorghum, sunflower, and tomatoes.

The nature of metolachlor residues in plants and animals is understood.  For metolachlor (and S-metolachlor, an enriched isomer) the residues of concern in plants and animals include the parent compound (both R and S-enantiomers) and its metabolites, determined as the derivatives CGA-37913 and CGA-49751 (for both tolerance and risk assessment purposes).  Following recommendations made in the revised Tolerance Reassessment Eligibility Decision (TRED) for Metolachlor and S-Metolachlor (D292881, S. Kinard, 8/15/03), tolerances for metolachlor and S-metolachlor have been separated.  Permanent tolerances for combined (free and bound) S-metolachlor residues have been established in/on plant commodities ranging from 0.1 ppm in/on a variety of crops to 20 ppm in/on peanut hay [40 CFR §180.368(a)(2)].  (Note:  The enforcement methods in PAM Vol. II both determine residues of metolachlor and its metabolitres as either CGA-37913 or CGA-49751 following acid hydrolysis.)  Permanent tolerances for indirect or inadvertent residues of metolachlor have also been established for non-grass animal feeds (group 18), and the forage, hay, grain and straw of small cereal grains (barley, buckwheat, oats, rice, rye and wheat).  Tolerances for rotational crops range from 0.1 ppm in/on various cereal grains to 1.0 ppm in/on non-grass animal feeds and hay of barley, oats and wheat [40 CFR §180.368(d)].

Adequate methodology is available for enforcing the current tolerances.  The Pesticide Analytical Manual (PAM, Vol. II) lists a GC/NPD method (Methods I) for determining residues in/on plants and a GC/MSD method (Method II) for determining residues in livestock commodities.  These methods determine residues of metolachlor and its metabolites as either CGA-37913 or CGA-49751 following acid hydrolysis.  Adequate data are available on the recovery of metolachlor through multi-residue method testing protocols.  The FDA PESTDATA database indicates that metolachlor is completely recovered through Method 302, PAM Vol. I (3rd ed., revised 10/97).

S  SEQ CHAPTER \h \r 1 torage stability data are available for other plant commodities that could translate to support the sample storage conditions and durations from the submitted field trials.  Data are available indicating that CGA-37913 is stable at ≤10°C for at least 24 months in corn (grain and forage), peanuts, potatoes (tubers, wet peel and flakes), soybean (hulls and meal), and tomatoes, for at least 29 months in cottonseed oil, and for at least 37 months in cottonseed and corn oil.  The derivative CGA-49751 is also stable at ≤10°C for at least 24 months in corn (grain and forage), peanuts, potatoes (tubers, wet peel and flakes), soybean (hulls and meal), and tomatoes, and for at least 37 months in cottonseed and cottonseed oil (D282931, S. Kinard, 4/22/2002).

Storage stability data relating to this specific study (i.e., Crop Subgroup 6-b field trial data) have not been submitted to demonstrate the stability of metolachlor and its metabolites in Crop Subgroup 6-b, matrices; however, a storage stability study was reported to be underway at the time of the study report publication.  This study should be submitted.

The submitted Crop Subgroup 6-b, legume vegetable field trial data are not adequate by themselves to support the use of metolachlor on succulent shelled peas and beans (Crop Subgroup 6-b).  However, when related data from Crop Subgroups 6-a and 6-c and other existing Crop Subgroup 6-b data are evaluated together with these data; the overall data are adequate for tolerance reassessment of Crop Subgroup 6-b commodities.

An adequate confined rotational crop study is available (D341704, D. Soderberg, 11/28/2007).  That study shows that total radioactive residues (TRR) for all commodities except wheat grain are significantly greater than 0.1 ppm at all plant back intervals.  TRR for wheat grain are 0.5 ppm at a 30-day plantback interval (PBI), but are only about 0.05 ppm for all longer intervals.  Analyses for metolachlor, per se, show, at most, only very trace findings in any crops where they have been done.  The residues of concern in rotated crops are the same as in the primary crops, metolachlor and its metabolites determined as CGA-37913 and CGA-49751.

The submitted wheat and oat rotational crop field trials are adequate and support the minimum PBI of 4.5 months for barley, oats, rye and wheat.

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

No major deficiencies were noted in the submitted field trials or rotational crop field trials that would preclude reassessing tolerances for metolachlor residues in/on Crop Subgroup 6-b, legume vegetables (except soybean), or for rotational small cereal grains.  However, a few minor deficiencies must be resolved as a condition of registration (see below).

A revised human health risk assessment is not required for metolachlor for the following reasons:  1) The tolerance for Crop Subgroup 6-b commodities was reassessed at its current value of 0.3 ppm. 2) Only very minor changes have been made to crop rotation tolerances with the reassessed or calculated tolerance being lower for both significant feed items, i.e., grain and forage.  The reassessed tolerance for straw was slightly higher and would not affect secondary residues in livestock commodities. 3)  There have been no changes in the toxicology database since the last human health risk assessment was conducted which was associated with the RED/TRED (TRED for Metolachlor and S-Metolachlor, D292881, S. Kinard, 8/15/03).  For these reasons, the exposure and risk estimates given in the previous risk assessment do not increase for the general U.S. population or any population subgroup.

HED recommends establishing a reassessed permanent tolerance for the combined residues of  metolachlor and its metabolites in/on the succulent, shelled peas and beans (Crop Subgroup 6-b) at 0.3 ppm.  The use it supports is a single broadcast soil or PPI application at planting or as a single broadcast foliar application.  The data support maximum single and seasonal use rates of 1.33 lb ai/A for coarse soils or 1.67 lb ai/A for medium soils, and a 50-day PHI.  The residue data indicate that the tolerance of 0.3 ppm for Crop Subgroup 6-b is adequate.

HED recommends for the revision of, and/or the establishment of, indirect or inadvertent tolerances (40CFR 180.368(d)), as specified in Table 8 under the heading “reassessed tolerances.”  The registrant should submit a petition to revise these tolerances.  End-use labels for metolachlor should reflect the 4.5 month (135-day) plant back interval restriction, as reflected in the submitted study (as well as the maximum seasonal application rate of 3.0 lbs ai/A).

Additional Data Needs.

1)  Storage stability data relating to this specific study (i.e., Crop Subroup 6-b field trial data) have not been submitted to demonstrate the stability of metolachlor and its metabolites in the Crop Subgroup 6-b matrices.  A storage stability study was reported to be underway at the time of the study report publication.  The maximum storage interval from harvest to extraction was 250 days for forage, 216 days for hay, and 167 days for pods.  The study reported to be underway at the time of the study report publication should be submitted.

Background

  SEQ CHAPTER \h \r 1 Metolachlor [2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl) acetamide] is a selective, chloroacetanilide herbicide that is applied to a variety of crops as a preplant, PPI, preemergence, or post-emergence-directed application, primarily for the control of grass weeds.  Metolachlor is used on a wide variety of crops.  An extensive review of metolachlor uses and tolerances was conducted in the Revised TRED for Metolachlor and S-Metolachlor (D292881, S. Kinard, 8/15/03).

In response to deficiencies noted in these earlier reviews, the Metolochlor Task Force has provided the following data:  1) field trial data supporting the use of metolachlor on succulent shelled peas and beans, Crop Subgroup 6-b; and 2) field accumulation in rotational crop studies on representative small grains (wheat and oats).

The chemical structure and nomenclature of metolachlor and its derivatives CGA-49751 and CGA-37913, and the physicochemical properties of the technical grade of metolachlor are presented in Tables 1 and 2.

TABLE 1.	Test Compound Nomenclature.

Compound

Common name	Metolachlor

Company experimental name	Not applicable

IUPAC name 2-chloro-N-(6-ethyl-o-tolyl)-N-[(1RS)-2-methoxy-1-methylethyl]acetamide

or

)-2-chloro-6′-ethyl-N-(2-methoxy-1-methylethyl)acet-o-toluidide

CAS name 2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide

CAS registry number	51218-45-2

End-use product (EP)	Stalwart® Herbicide (EPA Reg. No. 60063-34; 8 lb/gal EC)

Compound

Common name	CGA-49751

Chemical name	4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholine

CAS registry number	61520-54-5

Compound

Common name	CGA-37913

Chemical name	2-[(2-ethyl-6-methylphenyl)amino]-1-propanol

CAS registry number	61520-53-4

TABLE 2.	Physicochemical Properties of Technical Grade Metolachlor

Parameter	Value	Reference1

Physical state (color)	Liquid (pale yellow to light brown)	TRED Product Chemistry Chapter (D274330)

Boiling point	100OC at 0.001 mm mercury.	RED

pH	7-9 @ 25OC (1% aqueous dispersion)	TRED Product Chemistry Chapter (D274330)

Density	1.117 g/mL at 20OC	TRED Product Chemistry Chapter (D274330)

Water solubility	0.48 g/L @ 25OC	TRED Product Chemistry Chapter (D274330)

Solvent solubility	Miscible in xylene, toluene,

ethylene dichloride, and cyclohexanone.	RED

Vapor pressure	2.8 x 10-5 mm Hg @ 25OC	TRED Product Chemistry Chapter (D274330)

Octanol/water partition coefficient, Log(KOW)	3.05 @ 25OC	TRED Product Chemistry Chapter (D274330)

860.1200  Directions for Use

Three end-use product labels (EPA Reg. Nos.:  19713-539, 56077-69, and 60063-17) were submitted with the two studies for HED review.  The submitted field trial data reflect the use of a single application of metolachlor at total application rates of 1.3-1.7 lb ai/A on pod crops (beans and peas) grown in the United States.

The end use labels have the following restrictions:  Do not apply more than 3 pints/A (3 lbs ai/A) of this product during one crop year.  One of the labels has the following restriction:  “FOR CA ONLY:  Broadcast this product to the soil and thoroughly incorporate with a disk or similar implement set to till to 4 to 6 inches deep.  For more thorough incorporation, till the soil in two different directions (cross-till).”

860.1300 Nature of the Residue - Plants

The qualitative nature of metolachlor residues in plants is adequately understood based upon the adequate corn, potato, and soybean metabolism studies.  The metabolism of metolachlor involves conjugation with glutathione, breakage of this bond to form the mercaptan, conjugation of the mercaptan with glucuronic acid, O-demethylation of the methyl ether, and conjugation of the resultant alcohol with a neutral sugar.  A minor pathway may involve sugar conjugation of metolachlor directly to the corresponding oxo-compounds.  Residues of concern in plants (for both tolerance and risk assessment purposes) include metolachlor and its metabolites, determined as the derivatives CGA-37913 and CGA-49751.

The Agency has also reviewed plant metabolism data on S-metolachlor from field tests on soybeans and corn, in vitro tests on corn seedlings, and greenhouse tests on seedlings of corn, sorghum, soybeans and peanuts (D279110, S. Kinard, 8/15/03).

860.1300 Nature of the Residue - Livestock

Adequate studies are available depicting the metabolism of metolachlor in ruminants and poultry.  Metolachlor is rapidly metabolized and almost totally eliminated in the urine and feces of ruminants (goats), non-ruminants (rats), and poultry.  Metolachlor per se was not detected in any of the excreta or tissues.  As in plants, metolachlor residues of concern in animal commodities include metolachlor and its metabolites, determined as the derivatives CGA-37913 and CGA-49751.

The Agency has also reviewed animal metabolism data on S-metolachlor (D292881, S. Kinard, 8/15/03).  Data from a goat metabolism study indicated that S-metolachlor was readily absorbed and extensively metabolized by goats via glutathione conjugation and/or oxidation reactions.  Oxidized metabolites were also conjugated with glucuronic acid.  Data from a poultry metabolism study indicated that S-metolachlor was also extensively metabolized via O-demethylation and subsequent glucuronic acid conjugation or oxidation to dihydroxy or carboxylic acid metabolites that may also be conjugated with glucuronic acid.

860.1340 Residue Analytical Methods

Enforcement methods:    SEQ CHAPTER \h \r 1 Adequate methodology is available for enforcing the established and recommended tolerances.  The Pesticide Analytical Manual (PAM) Vol. II, Pesticide Regulation Section 180.368 lists a GC/NPD method (Methods I) for determining residues in/on plants and a GC/MSD method (Method II) for determining residues in animal commodities.  These methods determine residues of metolachlor and its metabolites as either CGA-37913 or CGA-49751 following acid hydrolysis.

Data-gathering methods:

Crop Subgroup 6-b, vegetables:  The samples were analyzed using EPL-BAS method 478S01B-1, which is based on the analytical method appearing in PAM II, Section 180.368.  Concurrent laboratory fortification samples were prepared for each matrix from each site and run with each analytical set.  Fortifications took place using metolachlor and each of the two metabolites (CGA 37913 and CGA 49751).  Overall, individual concurrent recoveries ranged from 67% to 118% for metolachlor, from 72% to 106% for CGA 37913, and from 71% to 118% for CGA 49751.

Field Accumulation in Rotational Crops Study:  Samples of rotated oat and wheat commodities were analyzed for residues of metolachlor and its metabolites convertible to CGA-49751 and CGA-37913 using an LC/MS/MS method.  The method was developed from the GC/NPD enforcement method for plant commodities, Method I in the Pesticide Analytical Manual Vol. II.

Briefly, samples were subjected to acid hydrolysis in 6 N HCl at reflux for 16 hours (or overnight) to convert residues of metolachlor and its metabolites to either CGA-49751 or CGA-37913.  The hydrolysate was isolated by filtration and diluted to volume with water.  An aliquot was partitioned four times with dichloromethane (DCM).  The DCM phases, which contain CGA-49751, were combined, and the aqueous phase, which contains CGA-37913, was reserved.  The combined DCM  phases were concentrated and partitioned with 5% sodium carbonate; the DCM phase was concentrated to near dryness and reconstituted in acetonitrile: water (1:1; v:v) for analysis.  For determination of CGA-37913, the reserved aqueous phase was made basic with 50% NaOH and partitioned twice with hexane.  The hexane phases were combined, evaporated to dryness, and reconstituted in acetonitrile: water (1:1; v:v) for analysis.  The extracts were analyzed by LC/MS/MS using a reverse phase column and a gradient mobile phase of water and acetonitrile, each containing 0.5% formic acid.  Residues were quantified using external standards.  The registrant stated that, because matrix suppression of CGA-49751 was observed, residues of this analyte were quantified using a calibration curve of matrix-matched standards.

The reported limit of detection (LOD) was 0.002 ppm and the limit of quantitation (LOQ) was 0.010 ppm for each analyte in oat and wheat commodities, expressed as parent equivalents.  The LOQs expressed as CGA-49751 and CGA-37913 equivalents were 0.0088 ppm and 0.0068 ppm, respectively.   The method was validated prior to sample analysis using untreated samples of rotated wheat commodities fortified with each analyte at the LOQ, 10xLOQ, and 50xLOQ for forage, hay, and straw, and the LOQ and 10xLOQ for wheat grain.  In addition, the method was validated concurrently with sample analysis by fortifying samples of each rotated crop commodity (except wheat forage) with each analyte at the LOQ and 10xLOQ.

Conclusions.  Adequate enforcement methods are available for determining residues in plant and animal commodities, and the LC/MS/MS methods used for data collection in the submitted field trials and processing studies were adequately validated in conjunction with the analysis of treated samples from each of the studies.

860.1360 Multiresidue Methods

  SEQ CHAPTER \h \r 1 Adequate data are available on the recovery of metolachlor through multiresidue method testing protocols.  The FDA PESTDATA database indicates that metolachlor is completely recovered through Method 302, PAM Vol. I (3rd ed., revised 10/97).

860.1380 Storage Stability

No storage stability data were submitted to support this specific study; however, a study was reported to be underway.  S  SEQ CHAPTER \h \r 1 torage stability data are available for other plant and animal commodities (D166637, B. Cropp-Kohlligian, 4/16/92).  For plant commodities, the available data indicate that CGA-37913 is stable at ≤-10°C for at least 2 years in corn (grain and forage), peanut, potato (tubers, wet peel and flakes), soybean (hulls and meal) and tomatoes, for at least 29 months in cottonseed oil, and for at least 37 months in cottonseed and corn oil.  The derivative CGA-49751 is also stable at ≤-10°C for at least 2 years in corn (grain, forage, and oil), peanuts, potatoes (tubers, wet peel and flakes), soybeans (hulls and meal) and tomatoes, and for at least 37 months in cottonseeds and cottonseed oil.  In addition, storage stability studies conducted concurrently with the asparagus, green onion, and carrot field trials also indicate that both analytes are stable at -20°C for at least 14.1 months in asparagus, 24.3 months in carrots, and 21.7 months in green onions.

Conclusions.  Storage stability data are available for translation to support the storage durations and conditions for samples from the submitted field trials and field accumulation study.  However; a storage stability study was reported to be underway at the time of the study report publication and should be submitted.  Samples from the Crop Subgroup 6-b trials were stored frozen (-20(C) prior to analysis; the maximum storage interval from harvest to extraction was 250 days (ca. 8 months) for forage, 216 days (ca. 7 months) for hay, and 167 days (ca. 5 months) for pods.

860.1500 Crop Field Trials

47015301.der.doc  Legume Vegetables, Succulent Shelled Beans and Peas (Crop Subgroup 6-b)

HED’s review dated May 22, 2002 (D282931; S. Kinard) stated that:  “Current tolerances on seed and pod vegetables (excluding soybean) should be replaced by separate tolerances for the subgroup for the edible-podded legume vegetables, dried shelled peas and beans (except soybean), and succulent shelled peas and beans.”  That review further stated that: “Adequate metolachlor residue data are available on edible-podded and shelled dried peas and beans; however, data are required on representative succulent shelled peas and beans.”  HED’s review (D206103, David Miller, “Addendum to the RED”) of magnitude of the residue data for legume vegetables cited three MRIDs as providing data for this crop group:  00064182, 00128731, and 43295701.  MRID 00064182 contains Crop Group 6 data analyzed by Craven Labs and is not being used in this analysis.

That review went on to state:  “Adequate residue data are available to support uses on edible-podded and dried shelled legume vegetables (excluding soybean).  Following a PPI application of metolachlor at 3.0 lb ai/A, combined residues were <0.08-0.44 ppm in/on edible podded peas and beans and <0.08-<0.11 ppm in/on dried shelled peas and beans.  However, adequate data are not available on shelled, succulent peas and beans; these data are required”.

The Metolachlor Task Force sponsored a field trial study for metolachlor on Crop Subgroup 6-b.  Five field trials were conducted in the United States using succulent beans (four trials) and succulent peas (one trial) during the 2005 growing season.  The trials with beans encompassed Zones 1 (1 trial in Pennsylvania), 2 (1 trial in New Jersey, 1 trial in Georgia), and 3 (1 trial in Florida) and the trial with peas encompassed Zone 1 (1 trial in New Jersey).  At each location, there was one treated plot and one untreated plot. Treated plots received one pre-plant incorporated application of Stalwart® Herbicide, an emulsifiable concentrate (EC) formulation.  Each application was performed at a nominal application rate of 1.33 lb ai/A for coarse soils or 1.67 lb ai/A for medium soils. Adjuvants were not added to the spray mixtures.  At each site, duplicate bean or pea samples, forage (green vine) samples, and hay samples were collected from the control and treated plots at normal harvest.  Prior to collection of the hay samples, the hay was dried for 3 to 7 days in the field or under shelter after harvest.  Pre-harvest intervals (PHIs) ranged from 51 to 69 days for peas, or beans, and forage, and from 54 to 76 days for hay.

The analytical method used to analyze samples for this study was EPL-BAS method 478S01B-1, which allows for quantification of metolachlor by quantifying the amounts of the pair of acid hydrolyzed products CGA 37913 and CGA 49751.  Samples were analyzed using high performance liquid chromatography with tandem mass selective detection (HPLC/MS/MS).  The method is based on the analytical method appearing in PAM II, Section 180.368. Method validation and concurrent laboratory fortified samples were prepared using metolachlor and the metabolites CGA 37913 and CGA 49751.

Following a single application of metolachlor at a rate of 1.33 lb ai/A to 1.67 lb ai/A, combined residues of CGA 37913 and CGA 49751 (total metolachlor equivalents) ranged from below the LOQ to 0.089 ppm in succulent beans and peas, 0.41 ppm to 2.3 ppm in bean and pea forage, and 0.12 ppm to 0.49 ppm in bean and pea hay (Table 3).

Method validation samples were prepared and analyzed prior to the study using sample matrices collected from Field Trial Site 1 (PA site).  Additionally, concurrent laboratory fortification samples were prepared for each matrix from each site and run with each analytical set.  Fortifications took place using metolachlor and each of the two metabolites (CGA 37913 and CGA 49751).  Both metabolite fortifications were made to the same sample.  The metolachlor fortifications were made to a different sample.  Target fortification levels for method validation fortifications were the LOQ (0.01 ppm) and 10X LOQ (0.1 ppm) and target fortification levels for the concurrent laboratory fortifications ranged from 0.01 ppm to 0.1 ppm for pods, from 0.01 ppm to 0.25 ppm for forage, and from 0.1 ppm to 3 ppm for hay.  Overall, individual concurrent recoveries ranged from 67% to 118% for metolachlor, from 72% to 106% for CGA 37913, and from 71% to 118% for CGA 49751.

The following issues should be noted with regard to the fortification results:

The study author corrected the recoveries for the residue detected in control replicate A only.  The study report did not explain why control replicate B was not used in the correction.

Recoveries for metolachlor fortifications are based only on the concentration of metabolite CGA 37913.  According to the Study Report, it has been demonstrated that this metabolite is the only metabolite found upon analysis of the hydrolysate.  Additionally, a correction factor of 2 was applied to the recoveries from the metolachlor fortifications because the study report states that only about a 50% yield of CGA 37913 is expected after exhaustive hydrolysis of metolachlor (EPA Recovery Study, PAM Volume II, Section 180.368).  A correction factor was applied to metolachlor recoveries as a means of normalizing the data to a 100% recovery basis. This was done to show that metolachlor recoveries fall within an approximate range of 70-120%, given the limitations of the reaction yield.  The metolachlor recovery data were presented to demonstrate that the parent molecule hydrolysis was consistent and were not used as a definitive means of evaluating the validity of individual analytical sets.

TABLE 3.	Summary of Residue Data from Crop Field Trials with Metolachlor

Matrix	Total Applic. Rate

 [lb a.i./A]	Residue Levels

 (ppm)

N	Min.	Max.	HAFT	Median

(STMdR)	Mean

(STMR)	Std. Dev.

Total Metolachlor Residue (ppm)

Pod (Bean or Pea)	1.31 to 1.72	10	0.02 (<LOQ)	0.089	0.087	0.047	0.048 0.025

Hay

10	0.41	2.3	2.0	1.0	1.1	0.60

Forage

10	0.12	0.49	0.47	0.31	0.30	0.12

CGA 37913 Residue (Metolachlor equivalents, ppm)

Pod (Bean or Pea)	1.31 to 1.72	10	0.01 (<LOQ)	0.074	0.073	0.035	0.036 0.024

Hay

10	0.34	1.9	0.99	0.83	0.86	0.51

Forage

10	0.089	0.42	0.40	0.235	0.23	0.11

CGA 49751 Residue (Metolachlor equivalents, ppm)

Pod (Bean or Pea)	1.31 to 1.72	10	0.01 (<LOQ)	0.015	0.015	0.010 (<LOQ) 0.012	0.0022

Hay

10	0.067	0.42	0.34	0.23	0.23	0.11

Forage

10	0.013	0.098	0.47	0.071	0.064	0.027

HAFT = Highest Average Field Trial.

LOQ = 0.01 ppm for each analyte

Statistical calculations were performed using a value of LOQ when residues were reported as <LOQ.

Conclusions:  The submitted field trial data reflect the use of a single application of metolachlor (Stalwart® Herbicide formulation) at total application rates of 1.3-1.7 lb ai/A on pod crops (beans and peas) grown in the United States.  Four bean trials and one pea trial were conducted; however, the EPA guidelines (860.1500, Table 3) recommend conducting six bean trials and six pea trials for Crop Subgroup 6-b.

OTHER METLACHLOR RESIDUE DATA FOR CROP GROUP 6

In MRID 00128731 there are limited data for Crop Subgroup 6-b (lima beans, pods and beans), for California and New York.  Five trials were performed: 4 for beans and one for peas.  The pertinent residue data from that study are as follows:

California    <0.08, <0.08.

New York   <0.08, <0.08, 0.16, 0.10, <0.08, <0.08, 0.15, 0.21.

In Table 4. residue data from MRID 43295701 for Crop Group 6 commodities are summarized.  While there are no data in this study for Crop Subgroup 6-b, it does indicate that residues are higher for Crop Subgroup 6-a commodities, and that a Crop Group tolerance is not appropriate.  Therefore, the data will not be translated to Crop Subgroup 6-b.

Table 4.  Other Crop Group 6, Residue Data  (MRID 43295701).

Test Location	PHI	Residue	Subgroup

Peas, dried

Washington	121	<0.08	6C

<0.08	“

Kansas	100	  0.04	“

  0.03	“

  0.04	“

<0.08	“

Pea, pods

Wisconsin	57	  0.05	6A

  0.06	“

California	52	  0.44	“

  0.39	“

Beans, dried

Washington	120	<0.08	6C

<0.08	 “

Colorado	102	<0.08	“

<0.08	“

Colorado

  0.03	6C

<0.08	“

California	119	  0.03	“

<0.08	“

Tennessee	65	  0.06	“

  0.04	“

Michigan	95	  0.04	“

  0.04	“

<0.08	“   Reanalysis

<0.08	“   Reanalysis

Bean, pods

Wisconsin	57	<0.08	6A

  0.03	“

Snap bean, pods

California	71	  0.24	6A

  0.20	“

  0.31	“  Reanalysis

  0.37	“  Reanalysis

Tennessee	60	  0.42	6A

  0.32	“

Michigan	63	  0.11	“

	63	  0.09	“

860.1650 Submittal of Analytical Reference Standards

The pesticide standards repository has recently depleted the supply of metolachlor parent CAS# 51218-45-2 from both MANA and the Metolachlor Task Force.  The repository has metolachlor oxanilic acid sodium salt (CGA-51202) CAS# 152019-73-3, lot # 8112-7-27 from the Metolachlor Task Force, but the certificate of analysis (COA) expired on 1/1/2008.    SEQ CHAPTER \h \r 1  The reference standard (or a reassay and an updated COA) should be sent to the Analytical Chemistry Lab, to the attention of Theresa Cole at the following address:

	USEPA

	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

	701 Mapes Road

	Fort George G. Meade, MD  20755-5350

(Note that the mail will be returned if the extended zip code is not used.)

If new COAs are being submitted, they should be faxed to the repository at<PHONE_NUMBER>.860.1900 Field Accumulation in Rotational Crops

47312501.der.doc  Field Accumulation in Rotational Crops using Wheat and Oats.

HED’s review dated Aug 15, 2003 (D255484, S. Kinard) stated that additional data were required depicting the residues of metolachlor in or on representative rotated cereal grains planted 4.5 months following a single application of metolachlor at the maximum rate for corn.  Field trials were to be conducted using wheat and oats.  Samples of forage, hay, straw and grain should be collected from each test of wheat and oats.  In addition, that review further stated that data for wheat and oats would be translated to support similar tolerances for barley, buckwheat, millet, rice, and rye.  It also stated that the established tolerances on milo commodities should be revoked as residues in/on milo commodities are covered by the current tolerances on sorghum.  In this review, the wheat data are translated to support barley, buckwheat, millet, rice, and rye because wheat commodities had the highest calculated tolerances (see Appendix I).

Recently HED has reviewed a confined rotational crop study for metolachlor using radish, lettuce, and wheat.  That review (D341704, D. Soderberg, 11/28/07) concluded that metolachlor residues in or on wheat grain were 0.54 ppm at 30 days, but otherwise declined to near 0.05 ppm and remained at this level until 360 days.  In wheat forage the TRR was 1.1 ppm at 30 days and  declined to 0.76 ppm at 360 days; in wheat straw the TRR dropped from 6.7 ppm at 30 days to 4.2 ppm at 360 days; TRR in wheat hay ranged from 6.4 ppm at 30 days to 2.6 ppm at 360 days.  In summary, the TRR exceeded 0.01 ppm for all the wheat commodities at 360 days.

The current field accumulation study provides information on the level of metolachlor residues in wheat and oat commodities (grain, forage, straw and hay) planted 133-136 days after the last application of metolachlor.

HED notes that the TRR and concentrations of parent metolachlor have now been adequately determined at the maximum application rates, for all plant back intervals tested; adequate characterization/identification of general metabolism has been provided for all commodities; and adequate characterization, in terms of the “enforcement method,” of the residues in radish, lettuce and wheat grain exist at 120 days.  The enforcement method involves hydrolysis of the many different metabolites of metolachlor to produce two common moiety molecules.

Table 5.  Summary of Indirect or Inadvertent  Tolerances for Metolachlor in or on Small Grains (40CFR 180.368(d)).

Commodity	Tolerance (pp)	Comments

Barley, grain	0.1

	Barley, hay	1.0

	Barley, straw	0.5

	Barley, forage	N/A	No tolerance listed.

Buckwheat, grain	0.1

	Buckwheat (hay, straw, forage)	N/A	No tolerances listed.

Oat, forage	0.5

	Oat, grain	0.1

	Oat, hay	1.0

	Oat, straw	0.5

	Rice, grain	0.1

	Rice, straw	0.5

	Rice, (forage, straw)	N/A	No tolerances listed.

Rye, grain	0.1

	Rye, straw	0.5

	Rye (forage, hay)	N/A	No tolerances listed.

Wheat, forage	0.5

	Wheat, grain	0.1

	Wheat, hay	1.0

	Wheat, straw	0.5

The Metolachlor Task Force submitted a field accumulation in rotational crops study for wheat and oats (which can be translated to support barley, buckwheat, millet, rice, and rye).  Two rotational crop studies were conducted using oat and wheat during the 2006-2007 growing season in California and Georgia.  Each trial consisted of one untreated plot, one treated plot, and at both sites, a primary crop of dry beans was planted.  At the CA site, the treated plot received one application of an 8 lb/gal emulsifiable concentrate (EC) formulation approximately 3 hours prior to planting dry beans, followed by a second application five days after the primary dry bean crop was harvested.  At the GA site, the treated plot received one application of an 8 lb/gal EC formulation one day after planting dry beans, followed by a second application one day after the harvest of the primary dry bean crop.  At both sites, the first application was made at a target rate of 1.33 lb ai/A/application and the second was made at a rate of 1.67 lb ai/A/application, with a 41- to 95-day retreatment interval, for a  total seasonal rate of 3.0 lb ai/A.  Applications were made using ground equipment in 20 gal/A spray volumes without the use of an adjuvant.

At the CA site, the dry bean plants were cut at the soil surface and then removed from the plot.  The method of destruction of the primary crop at the GA site was not described.  Rotational crops of oat and wheat were then planted at each site approximately 133-136 days after the last application of metolachlor.  Samples of oat and wheat forage, hay, grain, and straw were collected at appropriate crop growth stages, 98-101 days after planting (DAP) for forage, 126-136 DAP for hay, and 160-177 DAP for grain and straw.

Samples were stored frozen (<0ºC) from harvest to extraction for analysis for a maximum of 92 days (3.0 months) for forage, 97 days (3.2 months) for hay, 56 days (1.8 months) for grain, and 86 days (2.8 months) for straw; extracts were analyzed within 17 days of extraction.  To support sample storage conditions and durations, the registrant conducted a concurrent storage stability study with samples of fortified wheat commodities.  These data are adequate to support the storage conditions and durations of the rotational crop trials.

Samples of rotated oat and wheat commodities were analyzed using an LC/MS/MS method which determines residues of metolachlor and its metabolites convertible to CGA-49751 and CGA-37913 via acid hydrolysis.  The LOQ expressed as metolachlor equivalents was 0.01 ppm for each analyte, in each commodity.  The method was adequate for data collection based on generally acceptable method validation and concurrent method recovery data.  Concurrent method recoveries of CGA-49751 were low from straw samples (average of 58%); because recoveries were consistent, the method was deemed to be acceptable for data collection.

TABLE 6.  Summary of Residue Data in Rotational Crops Following Primary Treatment with Metolachlor.

Commodity	Applic. Rate

(lb ai/A)	PBI (days)	ppm, Metolachlor equivalents

	n	Min.	Max.	HAFT*	Median

(STMdR)	Mean

(STMR)	Std. Dev.

CGA-49751

Oat forage	3.0	133, 136	8	<0.01	0.065	0.040	0.019	0.025	0.020

Wheat forage

	8	<0.01	0.048	0.036	0.018	0.023	0.015

Oat hay	3.0	133, 136	8	<0.01	0.042	0.028	0.015	0.019	0.012

Wheat hay

	8	<0.01	0.085	0.076	0.038	0.043	0.035

Oat grain	3.0	133, 136	8	<0.01	<0.01	0.01	0.01	0.01	NA

Wheat grain

	8	<0.01	<0.01	0.01	0.01	0.01	NA

Oat straw	3.0	133, 136	8	<0.01	0.040	0.033	0.019	0.022	0.013

Wheat straw

	8	<0.01	0.106	0.097	0.049	0.054	0.047

* HAFT = Highest Average Field Trial

Following planting of rotational crops of oat and wheat 133 or 136 days after the last of two applications of an 8 lb/gal EC formulation to the soil at a total rate of 3.0 lb ai/A, total metolachlor residues in/on rotated oat and wheat commodities were, respectively:  <0.02-0.191 and <0.02-0.354 ppm in/on forage; <0.02-0.123 and <0.02-0.453 ppm in/on wheat hay; <0.02-<0.030 and <0.02-<0.027 ppm in/on grain; and <0.02-0.164 and <0.02-0.424 ppm in/on straw.  Residues of CGA-49751, expressed as metolachlor equivalents, in/on rotated oat and wheat commodities were, respectively:  <0.01-0.065 and <0.01-0.048 ppm in/on forage; <0.01-0.042 and <0.01-0.085 ppm in/on wheat hay; <0.01 ppm in/on grain; and <0.01-0.040 and <0.01-0.106 ppm in/on straw.  Residues of CGA-37913, expressed as metolachlor equivalents, in/on rotated oat and wheat commodities were, respectively:  <0.01-0.142 and <0.01-0.306 ppm in/on forage; <0.01-0.089 and <0.01-0.368 ppm in/on wheat hay; <0.01-0.020 and <0.01-0.017 ppm in/on grain, respectively; and <0.01-0.128 and <0.01-0.318 ppm in/on straw.

International Residue Limits

 TC \l3 " 5.1.11	International Residue Limits

Grains:

The following information was provided via email by Steve Funk, Ph.D. (5/1/2008):

a)  Metolachlor is not a Codex chemical, i.e., no MRLs.

b)  S-metolachlor (an enriched isomer of metolachlor) has MRLs in Canada, but none for small grains.  (There is an MRL for corn grain, 0.1 ppm.).

c)  Metolachlor has MRLs in Mexico, but none for small grains.  (There is an MRL for

     corn grain, 0.1 ppm)

Harmonization

The NAFTA Tolerance/MRL calculator indicates that a tolerance/MRL of 0.05 ppm is appropriate for rotational crop small grains; however, due to the existing 0.1 ppm MRLs for grains in both Canada and Mexico, HED recommends leaving the crop rotation grain tolerances at 0.1 ppm (Tables 5 and 7).

Crop Group 6 Commodities:

Canada has the following residue definition:  2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(1S)-2-methoxy-1-methylethyl)acet amide and 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(1R)-2-methoxy-1-methylethyl)acet amide including the metabolites 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(1S)-2-methoxy-1-methylethyl)acet amide and 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(1R)-2-methoxy-1-methylethyl)acet amide, including the metabolites 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone.  Mexico has the following residue definition:  S-metolachlor.

Selected MRLs (ppm) germane to this analysis for S-metolachlor are provided in Table 7 (Note:  It does not include all s-metolachlor MRLs):

Table 7. 	Selected MRLs for S-Metolachlor.

Commodity	Canada	Mexico

Bean	--	15

Chick pea	--	15

Corn, grain	0.1	0.1

Dry bean	0.3	--

Lentil	--	15

Lima bean	0.3	--

Pea	0.3	--

Snap bean	0.3	--

Sorghum, grain	--	0.3

Soybean, grain	0.2	0.2

Harmonization

Canada currently has a tolerance of 0.3 ppm for S-metolachlor in peas and snap beans. A higher United States tolerance could result in a trade irritant for these crops exported from the United States to Canada.  In addition, Canada has a tolerance of 0.3 ppm for S-metolachlor in dry beans. A lower United States tolerance could result in a trade irritant for these crops exported from Canada to the United States.  The residue data support harmonization of these tolerances at 0.3 ppm tolerance.

860.1550 Proposed Tolerances

Table 8.  Existing and Reassessed Indirect or Inadvertent Tolerances for Metolachlor for Small Grains (40CFR 180.368(d)).

Commodity	Existing Tolerance

 (ppm)	Reassessed Tolerance (ppm)

Barley, forage	No tolerance listed.	0.50  (0.45 calculated)*

Barley, grain	0.1	0.1 (0.05 calculated)**

Barley, hay	1.0	0.8

Barley, straw	0.5	0.8

Buckwheat, forage	No tolerance listed.	0.50  (0.45 calculated)*

Buckwheat, grain	0.1	0.1 (0.05 calculated)**

Buckwheat, hay	No tolerance listed.	0.8

Buckwheat, straw	No tolerance listed.	0.8

Oat, forage	0.5	0.50  (0.45 calculated)*

Oat, grain	0.1	0.1 (0.05 calculated)**

Oat, hay	1.0	0.4

Oat, straw	0.5	0.4

Rice, grain	0.1	0.1 (0.05 calculated)**

Rice, forage	No tolerance listed.	No tolerance required

Rice, hay	No tolerance listed.	No tolerance required

Rice, straw	0.5	0.8

Rye, grain	0.1	0.1 (0.05 calculated)**

Rye, forage	0.5	0.50  (0.45 calculated)*

Rye, hay 	No tolerance listed.	0.8

Rye, straw	0.5	0.8

Wheat, grain	0.1	0.1 (0.05 calculated)**

Wheat, forage	0.5	0.50  (0.45 calculated)*

Wheat, hay	1.0	0.8

Wheat, straw	0.5	0.8

*  The existing oat, rye and wheat forages tolerances are 0.5 ppm and, for harmonization purposes, HED recommends this level rather than the calculated values of 0.45 ppm.

** The NAFTA calculator indicates a tolerance of 0.05 ppm is appropriate; however, due to the existing 0.1 ppm MRLS for grains in both Canada and Mexico, HED recommends leaving the crop rotation grain tolerances at 0.1 ppm.

  SEQ CHAPTER \h \r 1 Attachment:

Appendix I - Tolerance Assessment CalculationsAppendix I.  Tolerance Assessment Calculations.

Crop Subgroup 6-b:  The dataset used to evaluate Crop Subgroup 6-b commodities  consisted of 10 field trials reflecting a single broadcast soil or PPI application at planting or as a single broadcast foliar application.  The data support maximum single and seasonal use rates of 1.33 lb ai/A for coarse soils or 1.67 lb ai/A for medium soils, and a 50-day PHI.  Other data from MRID 00128731 reflect 3.0 lb ai/A seasonal use rate and PHI of 88-123 days.  The residue data indicate that the existing tolerance of 0.3 ppm (the existing tolerance for pod vegetables) for Crop Subgroup 6-b is adequate.

Only 6 of the 20 field trial sample results were below the LOQ (LOQ = 0.08 ppm).  HED desired  a conservative estimate of the tolerance because the dataset reflected less than the normal 12 field trials for Crop Subgroup 6-b.  Therefore, maximum likelihood estimation (MLE) procedures were not used to impute the censored values.  Instead the LOQ value (0.08 ppm) was entered into the spreadsheet to calculate the required tolerance for Crop Subgroup 6-b.

Rotational Crops:  The dataset used to evaluate rotational crop tolerances for metolachlor on wheat and oat commodities consisted of field trial data reflecting rotational crops treated with metolachlor.  The first application was made at a target rate of 1.33 lb ai/A/application and the second was made at a rate of 1.67 lb ai/A/application, with a 41- to 95-day retreatment interval, for a  total seasonal rate of 3.0 lb ai/A.  Samples of oat and wheat forage, hay, grain, and straw were collected at appropriate crop growth stages, 98-101 days after planting (DAP) for forage, 126-136 DAP for hay, and 160-177 DAP for grain and straw.

Although the Guidance for Setting Pesticide Tolerances Based on Field Trial Data (SOP) specifies that the field trial application rates and PHIs should be within 25% of the maximum label application rate and minimum label PHI, respectively, the field trial data appear to represent the use pattern the petitioner wishes to support.  The residue values used to calculate the tolerance are provided in Tables II-2 through II-9.

Because 4 of 8 field trial sample results were below LOQ (LOQ = 0.08 ppm), maximum likelihood estimation (MLE) procedures were needed to impute censored values.  These values are indicated with the * symbol.  The data points were entered into the tolerance spreadsheet.  Visual inspection of the lognormal probability plot indicates that the dataset is reasonably lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure II-1) confirmed that the assumption of lognormality should not be rejected.

The field trial data for metolachlor represent a small dataset (i.e., less than 15 samples) and are reasonably lognormal.  Therefore, for all wheat and oat commodities the upper bound estimate of the 95th percentile based on the median residue value was compared to the minimum of the 95% upper confidence limit on the 95th percentile and the point estimate of the 99th percentile, and the minimum value was selected as the tolerance value.

Figure II-1.  Data Summary Table for Metolachlor Residues on Crop Subgroup 6-b Commodities.

	Regulator:	EPA

Chemical:	Metolachlor

Crop:	Crop Subgroup 6B

PHI:	51-69 Days

n:	20

min:	0.01

max:	0.21

median;	0.08

average:	0.08

95th Percentile	99th Percentile	99.9th Percentile

EU Method I

Normal	0.20	0.20	0.25

	(0.25)	(0.25)	(--)

EU Method I

Log Normal	0.25	0.45	0.90

	(0.50)	(1.1)	(--)

EU Method II

Distribution-Free

0.20

	California Method

Μ + 3σ

0.25

	UPLMedian95th

0.50

	Approximate Shapiro-Francia Normality Test Statistic	0.8941

	0.05 >= p-value > 0.01 : Reject lognormality assumption

Table II-1.	Metolachlor Residue Data for Crop Subgroup 6-b Commodities.

Metolachlor

Crop Subgroup,6B

51-69 Days

Residues

0.018

0.017

0.059

0.056

0.010

0.010

0.089

0.085

0.046

0.028

0.080

0.080

0.080

0.090

0.160

0.100

0.080

0.080

0.150

0.210

Figure II-2.  Data Summary Table for Metolachlor Residues on Oat Forage.

Table II-2.	Metolachlor Residue Data for Oat Forage.

EPA

Metolachlor

Oats, forage

Rotational Crop

Residues

0.191

0.107

0.170

0.170

0.008*

0.012*

0.014*

0.017*

Figure II-3.  Data Summary Table for Metolachlor Residues on Oat Hay.

Table II-3.  Metolachlor Residue Data for Oat Hay.

EPA

Metolachlor

Oats, hay

Rotational crop

Residues

0.093

0.109

0.106

0.123

0.008*

0.012*

0.014*

0.017*

Figure II-4.  Data Summary Table for Metolachlor Residues on Oat Grain.

Table II-4.  Metolachlor Residue Data for Oat Grain.

EPA

Metolachlor

Oats, grain

Rotational Crop

Residues

0.026

0.030

0.020

0.021

0.007*

0.010*

0.012*

0.014*

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Figure II-5.  Data Summary Table for Metolachlor Residues on Oat straw.

Table II-5.  Metolachlor Residue Data for Oat Straw.

EPA

Metolachlor

Oats, straw

Rotational crop

Residues

0.164

0.123

0.124

0.091

0.008*

0.012*

0.014*

0.017*

Figure II-6.  Data Summary Table for Metolachlor Residues on Wheat Forage.

Table II-6.  Metolachlor Residue Data for Wheat Forage.

EPA

Metolachlor

Wheat, forage

Rotational crop

Residues

0.163

0.102

0.354

0.262

0.008*

0.012*

0.014*

0.017*

Figure II-7.  Data Summary Table for Metolachlor Residues on Wheat hay.

Table II-7.  Metolachlor Residue Data for Wheat Hay.

EPA

Metolachlor

Wheat, hay

Rotational crop

Residues

0.352

0.453

0.331

0.213

0.008*

0.012*

0.014*

0.017*

Figure II-8.  Data Summary Table for Metolachlor Residues on Wheat grain.

Table II-8.  Metolachlor Residue Data for Wheat Grain.

EPA

Metolachlor

Wheat, grain

Rotational crop

Residues

0.025

0.027

0.025

0.026

0.008*

0.012*

0.014*

0.017*

Figure II-9.  Data Summary Table for Metoachlor Residues on Wheat straw.

Table II-9.  Metolachlor Residue Data for Wheat Straw.

EPA

Metolachlor

Wheat, straw

Rotational crop

Residues

0.424

0.344

0.306

0.365

0.008*

0.012*

0.014*

0.017*

Metolachlor                                                                          DP Barcodes:   336373/348268

PC Code 108800

 PAGE

 PAGE   1  of   NUMPAGES  30

DP Barcodes:   336373/348268


[Federal Register Volume 79, Number 108 (Thursday, June 5, 2014)]
[Notices]
[Page 32569]
[FR Doc No: 2014-13138]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2014-0006; OMB No. 1660-0011]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Debt Collection Financial Statement

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before July 7, 2014.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 500 C Street SW., Washington, DC 20472-
3100, facsimile number<PHONE_NUMBER>, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Collection of Information

    Title: Debt Collection Financial Statement.
    Type of information collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0011.
    Form Titles and Numbers: FEMA Form 127-0-1, Debt Collection
Financial Statement.
    Abstract: FEMA may request debtors to provide personal financial
information on FEMA Form 127-0-1 concerning their current financial
position. With this information, FEMA evaluates whether to allow its
debtors to pay their FEMA debts under installment repayment agreements
and if so, under what terms. FEMA also uses this data to determine
whether to compromise, suspend, or terminate collection efforts on
respondent's debts. This data is also used to locate the debtor's
assets if the debts are sent for judicial enforcement.
    Affected Public: Individuals or households.
    Estimated Number of Respondents: 2,000.
    Estimated Total Annual Burden Hours: 1,500 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $50,610.00. There are no annual costs to respondents'
operations and maintenance costs for technical services. There is no
annual start-up or capital costs. On February 18, 2014, FEMA published
a Notice for this information collection. 79 FR 9251. In that Notice,
FEMA indicated that the cost to the Federal Government was $189,319.75.
The cost of a U.S. postage stamp has increased, however, from $0.46 to
$0.49, and as a result, FEMA adjusts the total cost to the Federal
Government to $189,380.88 to reflect this change in the price of
postage.

    Dated: May 14, 2014.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2014-13138 Filed 6-4-14; 8:45 am]
BILLING CODE 9111-19-P


[Federal Register: April 1, 2009 (Volume 74, Number 61)]
[Rules and Regulations]
[Page 14734-14736]
[DOCID:fr01ap09-11]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[Docket No. EPA-R02-OAR-2008-0020; FRL-8775-6]

Approval and Promulgation of Implementation Plans; Variance
Determination for Particulate Matter From a Specific Source in the
State of New Jersey

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a
revision to the State Implementation Plan (SIP) submitted by the State
of New Jersey. This SIP revision consists of a source-specific
reasonably available control technology (RACT) determination for
controlling particulate matter from the cooling tower operated by the
PSEG Nuclear LLC Hope Creek and Salem Generating Stations. This action
approves a source-specific variance determination and emission
limitations that were made by New Jersey in accordance with the
provisions of its rule to help meet the national ambient air quality
standards (NAAQS) for particulate matter. The intended effect of this
rule is to approve source-specific emissions limitations required by
the Clean Air Act.

DATES: Effective Date: This rule will become effective on May 1, 2009.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R02-OAR-2008-0020. All documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically through
http://www.regulations.gov or in hard copy at the Environmental
Protection Agency, Region II Office, Air Programs Branch, 290 Broadway,
25th Floor, New York, New York 10007-1866. This Docket Facility is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The Docket telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Paul Truchan, Air Programs Branch,
Environmental Protection Agency, 290 Broadway, 25th Floor, New York,
New York 10278,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What Action Is EPA Taking Today?

    EPA is approving New Jersey's revision to the particulate matter
(PM) State Implementation Plan (SIP) submitted on November 2, 2007.
This SIP revision relates to New Jersey's PM variance determination for
the cooling tower at the PSEG Nuclear LLC Hope Creek and Salem
Generating Stations located in Lower Alloways Creek Township, Salem
County. As part of this variance evaluation, alternate emission
limitations are specified for total suspended particulates (TSP) and
PM-10 (particles with an aerodynamic diameter of 10 micrometers or
less). No variance was requested, or is being granted for PM2.5. This
evaluation and variance only involves the operation of the cooling
tower. The reader is referred to the proposed rulemaking on this action
(May 29, 2008, 73 FR 30873) for additional details.

II. What Comments Were Received and What Is EPA's Response?

    EPA received one anonymous comment which did not support the
variance request. The commenter indicated concern with the health
effects of particulate matter and the need to clean up our air. The
commenter also stated that the plant should be forced to upgrade and
that the proposed SIP revision should have included a discussion of
particulates smaller than 2.5 parts per million (ppm).
    EPA is also concerned with the health effects of particulates and
revised the national ambient air quality standard (NAAQS) for PM2.5 in
September 2006, lowering the 24-hour PM2.5 NAAQS from 65 [mu]g/
m3 to 35 [mu]g/m\3\ and readopted the annual PM2.5 NAAQS at
15 [mu]g/m\3\. States were required to make recommendations for
designating their counties as either attainment or nonattainment by
December 2007. On December 18, 2008, EPA's Administrator signed a final
rulemaking containing the new PM2.5 air quality designations.
    Based on current air quality monitoring data, Salem County is in
attainment of the new 24-hour PM2.5 standard. Salem County is currently
designated as attaining the previous 24-hour PM2.5 standard, and annual
PM2.5 standard, and this is confirmed with air quality monitoring data.
Therefore, the County where the cooling tower is located is currently
attaining the 65 [mu]g/m\3\ NAAQS and is also attaining the new lower
35 [mu]g/m\3\ NAAQS.

    As part of the requirements for obtaining a variance, an air
quality modeling analysis may be required. Such an analysis was
performed for the potential increase in emissions from the PSEG cooling
tower which looked at annual and 24-hour TSP, PM10 and PM2.5 standards.
The PM2.5 standard regulates fine particulates with an aerodynamic
diameter of 2.5 micrometers or less (that is, all particulates 2.5
micrometers and smaller). The proposed approval (73 FR 30874, May 29,
2008) and the air quality modeling analysis included in the Docket for
this action addressed the PM2.5 emissions from the cooling tower.
Maximum modeled concentrations were compared to the respective
significant impact levels. In general, concentrations of pollutants (in
micrograms per cubic meter) above the significant impact levels may
contribute to a violation of a NAAQS. However, in this case, the
modeled impact of all three pollutants was less than their respective
significance levels. In addition, the modeled impacts were added to the
area-wide background concentrations, and all the results were less than
the NAAQS. Therefore, the proposed SIP revision has demonstrated no
interference with any NAAQS and satisfied section 110(l) of the Act,
and EPA concludes the proposed SIP revision will not interfere with
attainment or any other requirements of the Act. Further, as discussed
in the proposal (73 FR 30873), the cooling tower will have its annual
allowable particulate matter emissions limited to 65.9 tons per year
(tpy) instead of the current allowable of 129 tpy. Under worst case
assumptions, hourly emissions are allowed to increase to 42.0 pounds
per hour (lbs/hr) from 29.4 lbs/hr. The worst-case particulate matter
emissions were modeled and are not predicted to cause an exceedance of
the NAAQS.
    The variance request also included a review of the existing
controls at PSEG's cooling tower, an evaluation of other methods of
reducing emissions at this facility, including the cost of these
controls, and a comparison of controls that could be required on newly
constructed cooling towers. The control efficiency currently measured
for this cooling tower is comparable to or better than similar cooling
towers documented in EPA's RACT/BACT/LAER Clearinghouse. Therefore, no
additional controls are feasible.
    In determining whether to approve the variance request submitted by
New Jersey, EPA was guided by the applicable rules contained in the
State Implementation Plan (SIP), the results of air quality monitoring
for the area, the results of air quality modeling of the proposed
impact of the variance request, and the results of the technological
and economic evaluations which were used to justify the variance. The
New Jersey Administrative Code, Title 7, Chapter 27, Subchapter 6,
Control and Prohibition of Particulates from Manufacturing Processes,
Section 6.5 specifically permits variances to be issued and provides
procedures and requirements which must be met in order for the variance
to be granted. New Jersey has demonstrated to EPA's satisfaction that
these requirements have been met and that the variance will not cause
or contribute to an exceedance of the applicable NAAQS.

III. Conclusion

    EPA is approving New Jersey's SIP revision request for a variance
and an alternative emission limit determination for the PSEG Nuclear
LLC Hope Creek and Salem Generating Stations cooling tower. This SIP
revision contains source-specific particulate emission limitations
contained in New Jersey's Air Pollution Control Operating Permit for
this source of: TSP less than or equal to 65.9 tpy, PM-10 less than or
equal to 65.9 tpy, TSP less than or equal to 42 lbs/hr, and PM-10 less
than or equal to 42 lbs/hr.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 1, 2009. Filing a
petition for reconsideration of this rule with the Administrator does
not affect the finality of this action for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness

of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: February 12, 2009.
George Pavlou,
Acting Regional Administrator, Region 2.

0
Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

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

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

0
2. Section 52.1570 is amended by adding new paragraph (c)(86) to read
as follows:

Sec.  52.1570  Identification of plan.

* * * * *
    (c) * * *
    (86) Revisions to the New Jersey State Implementation Plan (SIP)
for particulate matter granting a variance from Subchapter 6, Control
and Prohibition of Particles from Manufacturing Processes for the
cooling tower at the PSEG Nuclear LLC Hope Creek and Salem Generating
Stations located in Lower Alloways Creek Township, Salem County dated
November 2, 2007 submitted by the New Jersey State Department of
Environmental Protection (NJDEP) which establishes hourly emission
limits for TSP and PM-10 (total) of less than or equal to 42 pounds per
hour and annual emission limits for TSP and PM-10 (total) of less than
or equal to 65.9 tons per year.
    (i) Incorporation by reference:
    (A) A letter from Lisa P. Jackson, Commissioner, New Jersey
Department of Environmental Protection, addressed to Alan J. Steinberg,
Regional Administrator, EPA, dated November 2, 2007 submitting the
variance for PSEG Nuclear LLC Hope Creek and Salem Generating Stations
without the attachments.
    (B) Section J, Facility Specific Requirements, Emission Unit U24
Cooling Tower, (Significant Modification Approval date August 7, 2007)
contained in the Air Pollution Control Operating Permit, Significant
Modification and Preconstruction Approval, PSEG Nuclear LLC Hope Creek
and Salem Generating Stations, Permit Activity Number: BOP05003.
* * * * *

 [FR Doc. E9-7179 Filed 3-31-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Rules and Regulations]
[Pages 48384-48385]
[FR Doc No: 2018-20738]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[Docket No. EPA-R02-OAR-2018-0622; FRL-9984-35--Region 2]

Adequacy Status of Motor Vehicle Emissions Budgets for the New
Jersey Portion of the New York-Northern New Jersey-Long Island, NY-NJ-
CT 2008 8-hour Ozone Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification of adequacy.

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

SUMMARY: In this document, the Environmental Protection Agency (``EPA''
or ``Agency'') is notifying the public that the Agency has found that
the 2017 motor vehicle emissions budgets (``budgets'') for volatile
organic compounds (``VOCs'') and nitrogen oxides (``NOX'')
submitted by the New Jersey Department of Environmental Protection for
the 2008 national ambient air quality standard (``NAAQS'') for ozone
are adequate for transportation conformity purposes for the New Jersey
portions of the New York-Northern New

Jersey-Long Island, NY-NJ-CT 8-hour ozone nonattainment area. The
transportation conformity rule) requires that the EPA conduct a public
process and make an affirmative decision on the adequacy of these
budgets before they can be used by metropolitan planning organizations
in conformity determinations. As a result of this finding, upon the
effective date of this notification of adequacy, the North Jersey
Transportation Planning Authority must use these budgets in future
transportation conformity determinations. The budgets are contained in
New Jersey's December 22, 2017, state implementation plan submittal for
the 2008 8-hour ozone NAAQS and are associated with the reasonable
further progress milestone demonstration.

DATES: This finding is effective October 10, 2018.

FOR FURTHER INFORMATION CONTACT: Reema Loutan, Environmental Protection
Agency Region 2, Air Programs Branch, 290 Broadway, 25th Floor, New
York, New York 10007-1866;<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we,''
``us,'' or ``our'' is used, we mean the EPA.
    This document is simply an announcement of a finding that we have
already made. EPA Region 2 sent a letter to the New Jersey Department
of Environmental Protection on August 16, 2018, stating that the 2017
motor vehicle emissions budgets (``budgets'') in the submitted state
implementation plan (``SIP'') for the 2008 national ambient air quality
standard for ozone for the New Jersey portions of the New York-Northern
New Jersey-Long Island, NY-NJ-CT 8-hour ozone nonattainment area are
adequate for transportation conformity purposes. These budgets are
associated with the SIP's reasonable further progress milestone
demonstration and must apply to future transportation conformity
determinations conducted by the North Jersey Transportation Planning
Authority (``NJTPA'').
    On December 22, 2017, the New Jersey Department of Environmental
Protection submitted a SIP revision for the New Jersey portion of the
New York-Northern New Jersey-Long Island, NY-NJ-CT 2008 8-hour ozone
nonattainment area. This revision to the SIP included 2017 summer day
volatile organic compound (``VOC'') and nitrogen oxides
(``NOX'') motor vehicle emissions budgets associated with
the SIP's reasonable further progress demonstration. We announced
availability of the plan and related budgets on the EPA's
transportation conformity website on February 8, 2018, requesting
comments by March 12, 2018. We received no comments in response to the
adequacy review posting.
    This finding will also be available at the EPA's conformity
website: https://www.epa.gov/state-and-local-transportation/conformity-adequacy-review-region-2.
    The motor vehicle emissions budgets are provided in Table 1 below.

         Table 1--2017 Motor Vehicle Emissions Budgets for NJTPA
                             [Tons per day]
------------------------------------------------------------------------
                     Year                           NOX          VOC
------------------------------------------------------------------------
2017..........................................      103.22        48.69
------------------------------------------------------------------------

    Transportation conformity is required by Clean Air Act section
176(c). The EPA's conformity rule requires that long-range
transportation plans, transportation improvement programs, and
transportation projects conform to a state's air quality SIP and
establishes the criteria and procedures for determining whether or not
they conform. Conformity to a SIP means that transportation activities
will not produce new air quality violations, worsen existing
violations, or delay timely attainment of the NAAQS.
    The criteria the EPA uses to determine whether a SIP's motor
vehicle emission budgets are adequate for conformity purposes are
outlined in 40 CFR 93.118(e)(4). We have further described our process
for determining the adequacy of submitted SIP budgets in 40 CFR
93.118(f), and we followed this rule in making our adequacy
determination. Please note that an adequacy review is separate from the
EPA's completeness review and should not be used to prejudge the EPA's
ultimate action on the SIP. Even if we find a budget adequate, the SIP
could later be disapproved.
    Pursuant to 40 CFR 93.104(e), within 2 years of the effective date
of this document, NJTPA and the U.S. Department of Transportation will
need to demonstrate conformity to the new budgets. For demonstrating
conformity to the budgets in this plan, the on-road motor vehicle
emissions from implementation of the long-range transportation plan
should be projected consistently with the budgets in this plan.

    Authority:  42 U.S.C. 7401-7671q.

    Dated: September 5, 2018.
Peter D. Lopez,
Regional Administrator, Region 2.
[FR Doc. 2018-20738 Filed 9-24-18; 8:45 am]
 BILLING CODE 6560-50-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited, I have five children, two of which are two year old twins, and they require alot of my personal time. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life, and allowed me many more years to spend with my children. My Uncle died of lung cancer, which He contracted as a direct result of using traditional combustable cigarettes. His parent's had to bury their child due to his use of traditional combustable cigarettes. I for one do not want my children to have to bury me because I was not afforded an opportunity to quit smoking, and I have tried to quit using the many other forms of alternatives. The only one that has succesfully worked is the electronic cigarette. I wish to provide you with science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

                                                                    Thank you sincerely
                                                                                Jonathan Milner