Azinphos-methyl, Disulfoton, Esfenvalerate, Ethylene oxide, Fenvalerate, et al.; Proposed Tolerance Actions, 80317-80332 [E8-31182]
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Federal Register / Vol. 73, No. 251 / Wednesday, December 31, 2008 / Proposed Rules
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Program Authority: 20 U.S.C. 1098a.
Dated: December 24, 2008.
Vince Sampson,
Deputy Assistant Secretary for Postsecondary
Education.
[FR Doc. E8–31176 Filed 12–30–08; 8:45 am]
BILLING CODE 4000–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0834; FRL–8394–7]
Azinphos-methyl, Disulfoton,
Esfenvalerate, Ethylene oxide,
Fenvalerate, et al.; Proposed Tolerance
Actions
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
SUMMARY: EPA is proposing to revoke
certain tolerances for the fungicides
prothioconazole and thiabendazole; the
herbicide primisulfuron- methyl; and
the insecticides azinphos-methyl,
disulfoton, esfenvalerate, fenvalerate,
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and phosalone; the plant growth
regulator 1-naphthaleneacetic acid; and
the antimicrobial/insecticidal agent
ethylene oxide. Also, EPA is proposing
to modify certain tolerances for the
insecticides disulfoton, esfenvalerate,
and phosmet; and the plant growth
regulator 1-naphthaleneacetic acid. In
addition, EPA is proposing to establish
new tolerances for the insecticides
disulfoton, esfenvalerate, and phosmet;
and the antimicrobial/insecticidal agent
ethylene oxide and ethylene
chlorohydrin (a reaction product formed
during the fumigation/sterilization
process). The regulatory actions
proposed in this document are in
follow-up to the Agency’s reregistration
program under the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), and tolerance reassessment
program under the Federal Food, Drug,
and Cosmetic Act (FFDCA), section
408(q).
DATES: Comments must be received on
or before March 2, 2009.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2008–0834, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2008–
0834. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The regulations.gov website is an
‘‘anonymous access’’ system, which
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means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
regulations.gov, your e-mail address
will be automatically captured and
included as part of the comment that is
placed in the docket and made available
on the Internet. If you submit an
electronic comment, EPA recommends
that you include your name and other
contact information in the body of your
comment and with any disk or CD-ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. 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 in the
electronic docket at https://
www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Joseph Nevola, Special Review and
Reregistration Division (7508P), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave, NW., Washington, DC 20460–0001;
telephone number: (703) 308–8037; email address: nevola.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
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I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
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• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
Unit II.A. If you have any questions
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD-ROM that
you mail to EPA, mark the outside of the
disk or CD-ROM as CBI and then
identify electronically within the disk or
CD-ROM the specific information that is
claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
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vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
C. What Can I do if I Wish the Agency
to Maintain a Tolerance that the Agency
Proposes to Revoke?
This proposed rule provides a
comment period of 60 days for any
person to state an interest in retaining
a tolerance proposed for revocation. If
EPA receives a comment within the 60–
day period to that effect, EPA will not
proceed to revoke the tolerance
immediately. However, EPA will take
steps to ensure the submission of any
needed supporting data and will issue
an order in the Federal Register under
FFDCA section 408(f), if needed. The
order would specify data needed and
the timeframes for its submission, and
would require that within 90 days some
person or persons notify EPA that they
will submit the data. If the data are not
submitted as required in the order, EPA
will take appropriate action under
FFDCA.
EPA issues a final rule after
considering comments that are
submitted in response to this proposed
rule. In addition to submitting
comments in response to this proposal,
you may also submit an objection at the
time of the final rule. If you fail to file
an objection to the final rule within the
time period specified, you will have
waived the right to raise any issues
resolved in the final rule. After the
specified time, issues resolved in the
final rule cannot be raised again in any
subsequent proceedings.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to revoke, modify,
and establish specific tolerances for
residues of the fungicides
prothioconazole and thiabendazole; the
herbicide primisulfuron-methyl; and the
insecticides azinphos-methyl,
disulfoton, esfenvalerate, fenvalerate,
phosalone, and phosmet; the plant
growth regulator 1-naphthaleneacetic
acid; and the antimicrobial/insecticidal
agent ethylene oxide and its reaction
product ethylene chlorohydrin in or on
commodities listed in the regulatory
text.
EPA is proposing these tolerance
actions for disulfoton, ethylene oxide, 1naphthaleneacetic acid, and phosmet to
implement the tolerance
recommendations made during the
reregistration and tolerance
reassessment processes (including
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follow-up on canceled or additional
uses of pesticides). However, in the case
of prothioconazole, the proposed
tolerance revocation herein is not
associated with the reregistration or
tolerance reassessment processes, but
rather with an existing label prohibition.
In the cases of azinphos-methyl,
fenvalerate, primisulfuron-methyl, and
thiabendazole, the proposed tolerance
revocations herein are associated with
no active U.S. registrations for specific
food uses, and in the case of phosalone,
the proposed revocations are associated
with a follow-up to the withdrawal of a
comment to maintain tolerances for
import purposes, as described in Unit
II.A. In the case of esfenvalerate, an
isomer of fenvalerate, proposed
tolerances to be established (for those
food commodities with U.S.
registrations for esfenvalerate) are being
converted from fenvalerate tolerances
due to a phase out of fenvalerate use in
the United States, and the proposed
tolerance revocation on a processed
commodity tolerance is associated with
data that shows such residues are
covered by the appropriate tolerance on
the raw agricultural commodity for
which the Agency is proposing a
decreased level herein. As part of these
processes, EPA is required to determine
whether each of the amended tolerances
meets the safety standard of FFDCA.
The safety finding determination of
‘‘reasonable certainty of no harm’’ is
discussed in detail in each
Reregistration Eligibility Decision (RED)
and Report of the Food Quality
Protection Act (FQPA) Tolerance
Reassessment Progress and Risk
Management Decision (TRED) for the
active ingredient. REDs and TREDs
recommend the implementation of
certain tolerance actions, including
modifications to reflect current use
patterns, meet safety findings, and
change commodity names and
groupings in accordance with new EPA
policy. Printed copies of many REDs
and TREDs may be obtained from EPA’s
National Service Center for
Environmental Publications (EPA/
NSCEP), P.O. Box 42419, Cincinnati,
OH 45242–2419; telephone number: 1–
800–490–9198; fax number: 1–513–489–
8695; Internet at https://www.epa.gov/
ncepihom and from the National
Technical Information Service (NTIS),
5285 Port Royal Rd., Springfield, VA
22161; telephone number: 1–800–553–
6847 or (703) 605–6000; Internet at
https://www.ntis.gov. Electronic copies of
REDs and TREDs are available on the
Internet in public dockets for 1naphthaleneacetic acid (EPA–HQ–OPP–
2006–0507) and TREDs for ethylene
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oxide (EPA–HQ–OPP–2005–0203) and
primisulfuron-methyl (EPA–HQ–OPP–
2002–0163) at https://
www.regulations.gov and REDs for
azinphos-methyl, disulfoton, phosmet,
and thiabendazole at https://
www.epa.gov/pesticides/reregistration/
status.htm.
The selection of an individual
tolerance level is based on crop field
residue studies designed to produce the
maximum residues under the existing or
proposed product label. Generally, the
level selected for a tolerance is a value
slightly above the maximum residue
found in such studies, provided that the
tolerance is safe. The evaluation of
whether a tolerance is safe is a separate
inquiry. EPA recommends the raising of
a tolerance when data show that:
• Lawful use (sometimes through a
label change) may result in a higher
residue level on the commodity.
• The tolerance remains safe,
notwithstanding increased residue level
allowed under the tolerance.
In REDs, Chapter IV on ‘‘Risk
Management, Reregistration, and
Tolerance Reassessment’’ typically
describes the regulatory position, FQPA
assessment, cumulative safety
determination, determination of safety
for U.S. general population, and safety
for infants and children. In particular,
the human health risk assessment
document which supports the RED
describes risk exposure estimates and
whether the Agency has concerns. In
TREDs, the Agency discusses its
evaluation of the dietary risk associated
with the active ingredient and whether
it can determine that there is a
reasonable certainty (with appropriate
mitigation) that no harm to any
population subgroup will result from
aggregate exposure. EPA also seeks to
harmonize tolerances with international
standards set by the Codex Alimentarius
Commission, as described in Unit III.
Explanations for proposed
modifications in tolerances and/or
establishments of tolerances for
disulfoton, ethylene oxide, 1naphthaleneactic acid, and phosmet can
be found in the RED and TRED
document and in more detail in the
Residue Chemistry Chapter document
which supports the RED and TRED.
Esfenvalerate was not subject to the
reregistration program because it was
registered after November 1, 1984.
However, the explanation for the
proposed modification in one tolerance
and establishments of other tolerances
for esvenvalerate can be found in the
Residue Chemistry Chapter available in
the public docket for this proposed rule.
Copies of the Residue Chemistry
Chapter documents are found in the
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Administrative Record and paper copies
for ethylene oxide and 1naphthaleneacetic acid can be found
under their respective public docket ID
numbers, identified in Unit II.A. Paper
copies for disulfoton, esfenvalerate, and
phosmet are available in the public
docket for this proposed rule. Electronic
copies are available through EPA’s
electronic public docket and comment
system, regulations.gov at https://
www.regulations.gov. You may search
for docket ID number EPA–HQ–OPP–
2008–0834, then click on that docket ID
number to view its contents.
EPA has determined that the aggregate
exposures and risks are not of concern
for the above mentioned pesticide active
ingredients based upon the data
identified in the RED or TRED which
lists the submitted studies that the
Agency found acceptable.
EPA has found that the tolerances that
are proposed in this document to be
modified, are safe; i.e., that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residues, in accordance with
FFDCA section 408(b)(2)(C). (Note that
changes to tolerance nomenclature do
not constitute modifications of
tolerances). These findings are
discussed in detail in each RED or
TRED. The references are available for
inspection as described in this
document under SUPPLEMENTARY
INFORMATION.
In addition, EPA is proposing to
revoke certain specific tolerances
because either they are no longer
needed or are associated with food uses
that are no longer registered under
FIFRA. Those instances where
registrations were canceled were
because the registrant failed to pay the
required maintenance fee and/or the
registrant voluntarily requested
cancellation of one or more registered
uses of the pesticide. It is EPA’s general
practice to propose revocation of those
tolerances for residues of pesticide
active ingredients on crop uses for
which there are no active registrations
under FIFRA, unless any person in
comments on the proposal indicates a
need for the tolerance to cover residues
in or on imported commodities or
legally treated domestic commodities.
1. Azinphos-methyl. On December 28,
2005 (70 FR 76827) (FRL–7752–5), the
Agency published a notice in the
Federal Register and approved requests
from registrants to voluntarily amend
their product registrations to terminate
certain azinphos-methyl uses effective
December 28, 2005. These amendments
follow a September 30, 2002 Federal
Register Notice of Receipt of Requests
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(67 FR 61337) (FRL–7199–6) from the
azinphos-methyl registrants to amend
their product registrations to terminate
certain uses. The amendments
terminated azinphos-methyl use on a
number of commodities, including
alfalfa, bean (succulent and snap),
broccoli, cabbage (including chinese),
cauliflower, celery, citrus, clover,
cucumber, eggplant, grape, hazelnut
(filbert), melon, onion (green and dry
bulb), pecan, pepper, fresh plum, dried
plum, quince, spinach, strawberry,
tomato, and birdsfoot trefoil. All sale
and distribution of existing stocks of
end-use products bearing these uses by
registrants was prohibited 90-calendar
days after receipt of EPA approved
revised labels reflecting the use
deletions; i.e., after August 2003. The
Agency believes that end users will
have had sufficient time to exhaust
existing stocks and for treated
commodities to have cleared the
channels of trade. Therefore the
associated tolerances are no longer
needed. Consequently, EPA is proposing
to revoke the tolerances in 40 CFR
180.154 on alfalfa, forage; alfalfa, hay;
bean, snap, succulent; broccoli; cabbage;
cauliflower; celery; clover, forage;
clover, hay; cucumber; eggplant; fruit,
citrus, group 10; grape; hazelnut; melon;
onion; pecan; pepper; plum, prune;
quince; spinach; strawberry; tomato,
postharvest; trefoil, forage; and trefoil,
hay.
On July 5, 2006 (71 FR 38148) (FRL–
8076–4) and March 29, 2006 (71 FR
15731) (FRL–7771–4), the Agency
published notices in the Federal
Register and approved requests from
registrants to voluntarily amend their
product registrations to terminate
certain azinphos-methyl uses on
caneberry (blackberry, boysenberry,
loganberry, raspberry), cotton,
cranberry, nectarine (covered by the
peach tolerance under 40 CFR 180.1(g)),
peach, and potato effective September
30, 2006. The Agency believes that end
users will have had sufficient time for
treated commodities to have cleared the
channels of trade. Therefore the
associated tolerances are no longer
needed. Consequently, EPA is proposing
to revoke the tolerances in 40 CFR
180.154 on blackberry; boysenberry;
cotton, undelinted seed; cranberry;
loganberry; peach; potato; and
raspberry.
On March 26, 2008 (73 FR 16006)
(FRL–8355–1) and February 20, 2008
(73 FR 9328) (FRL–8349–8), the Agency
published notices in the Federal
Register and approved requests from
registrants to voluntarily cancel and
amend their product registrations to
terminate azinphos-methyl uses on
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Brussels sprouts effective September 30,
2008, on almonds, pistachios, and
walnuts effective October 30, 2009, and
on apples, blueberries, cherries, parsley,
and pears effective September 30, 2012.
Treated commodities subject to the final
rule and that are in the channels of trade
following the tolerance revocations are
subject to FFDCA section 408(l)(5).
Residues of pesticides whose tolerances
have been revoked do not render the
food adulterated so long as it is shown
to the satisfaction of the Food and Drug
Administration that residue is present
as the result of an application or use of
the pesticide at a time and in a manner
that was lawful under FIFRA and the
residue does not exceed the level that
was authorized at the time of the
application or use to be present on the
food under a tolerance or exemption
from tolerance. Evidence to show that
food was lawfully treated may include
records that verify the dates that the
pesticide was applied to such food.
Therefore, the associated tolerances will
no longer be needed after the last use
dates specified. Consequently, EPA is
proposing to revoke the tolerances in 40
CFR 180.154 on Brussels sprouts on the
date of publication of the final rule in
the Federal Register, on almond;
almond, hulls; pistachio; and walnut;
each with an expiration/revocation date
of October 30, 2009, and on apple;
crabapple; blueberry; cherry; parsley,
leaves; parsley, turnip rooted, roots; and
pear; each with an expiration/revocation
date of September 30, 2012.
In addition, because the tolerance
expired on June 30, 2000, EPA is
proposing to remove the tolerance in 40
CFR 180.154 on sugarcane, cane.
Also, EPA is proposing to revise the
section heading in 40 CFR 180.154 from
O,O-Dimethyl S-[(4-oxo-1,2,3benzotriazin-3(4H)yl)methyl]phosphorodithioate to that of
azinphos-methyl.
There are Codex Maximum Residue
Limits (MRLs) for residues of azinphosmethyl on alfalfa forage; almonds;
almond hulls; apple; blueberries;
broccoli; cherries; clover hay or fodder;
cottonseed; cranberry; cucumber; fruits
(except as otherwise listed); melons,
except watermelon; peach; pear; pecan;
peppers, chili (dry); peppers, sweet;
plums (including prunes); potato;
tomato; vegetables (except as otherwise
listed); and walnuts.
2. Disulfoton, O,O-Diethyl S-[2(ethylthio)ethyl]phosphorodithioate.
Currently, tolerances for disulfoton in
40 CFR 180.183(a) and (c) are
established for the combined residues of
disulfoton, O,O-diethyl S-[2(ethylthio)ethyl] phosphorodithioate,
and its cholinesterase-inhibiting
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metabolites, calculated as demeton.
Based on plant and animal metabolism
data, the Agency determined that
residues of concern should include the
sulfoxide and sulfone degradates and
oxygen analogues of the sulfoxide and
sulfone degradates and calculated as
disulfoton in compatibility with the
Codex expression. Therefore, EPA is
proposing to revise the introductory text
containing the tolerance expression in
40 CFR 180.183(a) to read as follows:
‘‘Tolerances are established for the
combined residues of the insecticide
disulfoton, O,O-diethyl S-[2(ethylthio)ethyl] phosphorodithioate;
demeton-S, O,O-diethyl S-[2(ethylthio)ethyl] phosphorothioate;
disulfoton sulfoxide, O,O-diethyl S-[2(ethylsulfinyl)ethyl]
phosphorodithioate; disulfoton oxygen
analog sulfoxide, O,O-diethyl S-[2(ethylsulfinyl)ethyl] phosphorothioate;
disulfoton sulfone, O,O-diethyl S-[2(ethylsulfonyl)ethyl]
phosphorodithioate; and disulfoton
oxygen analog sulfone, O,O-diethyl S-[2(ethylsulfonyl)ethyl] phosphorothioate;
calculated as disulfoton, in or on food
commodities as follows.’’
Also, EPA is proposing to revise the
introductory text containing the
tolerance expression in 40 CFR
180.183(c) to read as follows:
‘‘Tolerances with regional registration
are established for the combined
residues of the insecticide disulfoton,
O,O-diethyl S-[2-(ethylthio)ethyl]
phosphorodithioate; demeton-S, O,Odiethyl S-[2-(ethylthio)ethyl]
phosphorothioate; disulfoton sulfoxide,
O,O-diethyl S-[2-(ethylsulfinyl)ethyl]
phosphorodithioate; disulfoton oxygen
analog sulfoxide, O,O-diethyl S-[2(ethylsulfinyl)ethyl] phosphorothioate;
disulfoton sulfone, O,O-diethyl S-[2(ethylsulfonyl)ethyl]
phosphorodithioate; and disulfoton
oxygen analog sulfone, O,O-diethyl S-[2(ethylsulfonyl)ethyl] phosphorothioate;
calculated as disulfoton, in or on food
commodities as follows.’’
In the Federal Register of May 21,
2008 (73 FR 29507) (FRL–8364–7), EPA
issued a notice regarding EPA’s
announcement of the receipt of requests
from a registrant to voluntarily amend
certain registrations for disulfoton,
including deletion of the last barley and
wheat uses from disulfoton
registrations. EPA approved the barley
and wheat use deletions for disulfoton
and issued a cancellation order on July
30, 2008 (73 FR 44263) (FRL–8375–7)
and permitted the registrants to sell and
distribute product under the previously
approved labeling for a period of 6
months after the effective date of the
cancellation order; i.e., until January 30,
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2009. The Agency believes that end
users will have had sufficient time to
exhaust existing stocks and for
disulfoton-treated barley and wheat
commodities to have cleared the
channels of trade by January 30, 2010.
Therefore, EPA is proposing to revoke
the tolerances in 40 CFR 180.183(a) on
barley, grain; barley, straw; wheat, hay;
wheat, grain; and wheat, straw; each
with an expiration/revocation date of
January 30, 2010. In addition, based on
field trial data and in order to be
compatible with Codex MRLs of 0.2
milligram/kilogram (mg/kg), EPA
determined that the tolerance on wheat,
grain should be decreased from 0.3 to
0.2 parts per million (ppm). Also, the
Agency determined that wheat data may
be translated to barley and the tolerance
on barley, grain should be decreased
from 0.75 to 0.2 ppm. Therefore, EPA is
proposing to decrease the tolerances in
40 CFR 180.183 on barley, grain and
wheat, grain; each to 0.2 ppm, the
appropriate tolerance level for the
interim period before each tolerance
expires on January 30, 2010.
Available wheat processing data
showed that disulfoton residues of
concern concentrated in wheat aspirated
grain fractions at 1.35X and based on a
reassessed tolerance for wheat, grain at
0.2 ppm (see the disulfoton RED), and
the translation of wheat data to barley,
EPA determined that a tolerance should
be established on aspirated grain
fractions at 0.3 ppm. Therefore, EPA is
proposing to establish a tolerance in 40
CFR 180.183(a) on grain, aspirated
fractions at 0.3 ppm with an expiration/
revocation date of January 30, 2010.
Based on available field trial data that
showed combined disulfoton residues of
concern as high as <0.2 ppm on coffee
beans, EPA determined that the
tolerance should be decreased from 0.3
to 0.2 ppm. Therefore, EPA is proposing
to decrease the tolerance in 40 CFR
180.183(a) on coffee, bean to 0.2 ppm.
In the Federal Register of September
12, 2008 (73 FR 53007) (FRL–8380–7),
EPA issued a notice regarding EPA’s
announcement of the receipt of requests
from a registrant to voluntarily cancel
certain registrations for disulfoton,
including termination of the last
spinach and tomato uses from
disulfoton registrations. On October 14,
2008, EPA approved the registration
cancellations for disulfoton and issued
a cancellation order to the registrant and
permitted the registrant to sell and
distribute product under the previously
approved labeling until April 11, 2009.
Typically, the Agency will permit a
registrant to sell and distribute existing
stocks for 1 year after the date the
cancellation request was received. Such
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policy is in accordance with the
Agency’s statement of policy as set forth
in the Federal Register of June 26, 1991
(56 FR 29362) (FRL–3846–4). However,
in this case, the registrant, Bonide
Products, Inc. (Bonide), has provided
information to the Agency that these
registrations were dormant, the
pesticide has not been recently
produced or distributed by Bonide, and
that no existing stocks provision is
needed by Bonide in association with
these cancellation requests. However, in
its request of April 11, 2008 for
voluntary cancellation, Bonide noted
that previously sold/distributed product
may be in the channels of trade. The
Agency believes that end users will
have had sufficient time (18 months) to
exhaust existing stocks and for
disulfoton-treated spinach and tomato
commodities to have cleared the
channels of trade by October 14, 2009.
Therefore, EPA is proposing to revoke
the tolerances in 40 CFR 180.183(a) on
spinach and tomato; each with an
expiration/revocation date of October
14, 2009.
Also, in Federal Register notices of
September 12, 2008 (73 FR 53007)
(FRL–8380–7) and May 21, 2008 (73 FR
29507) (FRL–8364–7), EPA announced
the receipt of requests from registrants
to voluntarily cancel certain or amend
registrations for disulfoton, which
include the last potato use registrations.
On October 14, 2008, the Agency issued
a cancellation order for specific Bonide
registrations and permitted the
registrant to sell and distribute product
under the previously approved labeling
until April 11, 2009. However, Bonide,
the registrant, had informed the Agency
in its request of April 11, 2008, that
while the associated registrations were
dormant ones where the pesticide has
not been recently produced or
distributed by the registrant such that it
did not need an existing stocks
provision, previously sold/distributed
product in the channels of trade would
need an existing stocks provision. The
Agency believes that end users will
have had sufficient time to exhaust
existing stocks and for disulfotontreated potato commodities to have
cleared the channels of trade by October
14, 2009. However, the Agency issued
an order on July 30, 2008 (73 FR 44263)
(FRL–8375–7) to amend and terminate
certain uses, including potato, for
specific Bayer CropSciences
registrations and permitted the
registrant to sell and distribute product
under the previously approved labeling
until January 30, 2009. The Agency
believes that end users will have had
sufficient time to exhaust existing stocks
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and for disulfoton-treated potato
commodities to have cleared the
channels of trade by January 30, 2010.
Consequently, using the latter date, EPA
is proposing to revoke the tolerance in
40 CFR 180.183(a) on potato with an
expiration/revocation date of January
30, 2010. In addition, based on field
trial data that showed disulfoton
residues of concern at less than 0.5
ppm, EPA determined that the tolerance
on potatoes should be decreased from
0.75 to 0.5 ppm. Therefore, EPA is
proposing to decrease the tolerance in
40 CFR 180.183 on potato to 0.5 ppm,
the appropriate tolerance level for the
interim period before it expires on
January 30, 2010.
In the Federal Register of December
15, 2004 (69 FR 75061) (FRL–7689–8),
EPA issued a notice which announced
the receipt of requests from a registrant
to voluntarily amend a specific
registration for disulfoton, including
deletion of the last peanut and pepper
uses. EPA approved the amendments,
including the peanut and pepper use
deletions for disulfoton in an order
issued on October 10, 2007 (72 FR
57571) (FRL–8151–8), and permitted the
registrant and others to sell, distribute,
and use product under the previously
approved labeling until stocks are
exhausted. The registrant and others
have had more than 4 years since the
voluntary amendment requests and
more than 1 year since the amendment
order to sell and distribute stocks and
the Agency believes that end users will
have had sufficient time to exhaust
existing stocks and for disulfotontreated peanut and pepper commodities
to have cleared the channels of trade by
January 30, 2010. Also, based on
available data that showed combined
disulfoton residues of concern below 0.1
ppm in or on nutmeat, the Agency
determined that the tolerance should be
decreased from 0.75 to 0.1 ppm.
Therefore, EPA is proposing to revoke
the tolerances in 40 CFR 180.183(a) on
peanut and pepper; each with an
expiration/revocation date of January
30, 2010, and decrease the tolerance on
peanut to 0.1 ppm for the interim period
before it expires.
There have been no active
registrations in the United States for
disulfoton use on peas since 2002. The
Agency believes that end users have had
sufficient time to exhaust existing stocks
and for disulfoton-treated peas to have
cleared the channels of trade. Therefore,
EPA is proposing to revoke the
tolerances in 40 CFR 180.183(a) on pea,
dry, seed; pea, field, vines; and pea,
succulent.
Based on available field trial data that
showed combined disulfoton residues of
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concern as high as 1.15 ppm on leaf
lettuce, EPA determined that the
existing tolerance for lettuce at 0.75
ppm should be revised and a separate
tolerance for leaf lettuce should be
increased from 0.75 to 2 ppm.
Therefore, EPA is proposing to revise
the tolerance on lettuce at 0.75 ppm in
40 CFR 180.183(a) and separate it into
lettuce, head at 0.75 and lettuce, leaf at
2 ppm. The Agency determined that the
increased tolerance is safe; i.e., there is
a reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue.
Based on available metabolism and
cattle feeding data (3.6X) that showed
combined disulfoton residues of
concern in milk were as high as 0.012
ppm, EPA calculated residues at the 1X
feeding level to be <0.01 ppm.
Therefore, EPA determined that a
tolerance should be established on milk
at 0.01 ppm with an expiration/
revocation date of January 30, 2010.
Also, based on available metabolism
and cattle feeding data (0.7X) that
showed combined disulfoton residues of
concern in or on meat and meat
byproducts as high as <0.01 ppm in fat
and muscle, and 0.03 ppm in kidney,
EPA calculated that residues at the 1X
feeding level are expected to be <0.05
ppm in meat byproducts. Therefore,
EPA determined that tolerances on the
fat, meat and meat byproducts of cattle,
goats, hogs, horses, and sheep should be
established at 0.05 ppm. Currently,
there are label restrictions against the
grazing of disulfoton-treated cotton
fields and feeding of treated cotton
forage to livestock and cotton forage is
not considered by EPA to be a
significant livestock feed item. While
cotton gin byproducts may occasionally
serve as a livestock feed, the Agency has
determined that there is no reasonable
expectation that disulfoton residues
would transfer to livestock tissue.
However, based on the feed crops of
barley, peanut, and wheat that are
proposed herein for tolerance
revocation, each with an expiration/
revocation date of January 30, 2010, the
Agency determined that the livestock
and milk tolerances should be
established, each with an expiration/
revocation date of January 30, 2010.
Consequently, EPA is proposing to
establish tolerances in 40 CFR
180.183(a) on cattle, fat; cattle, meat;
cattle, meat byproducts; goat, fat; goat,
meat; goat, meat byproducts; hog, fat;
hog, meat; hog, meat byproducts; horse,
fat; horse, meat; horse, meat byproducts;
sheep, fat; sheep, meat; and sheep, meat
byproducts, each at 0.05 ppm and with
an expiration/revocation date of January
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30, 2010, and on milk at 0.01 ppm with
an expiration/revocation date of January
30, 2010.
There are Codex MRLs for combined
residues of disulfoton, demeton-S, and
their sulfoxides and sulfones on a
number of commodities, including
barley, barley straw, peanut, wheat, and
wheat straw.
3. Esfenvalerate. Existing tolerances
for fenvalerate are proposed herein to be
converted to esfenvalerate tolerances for
those crops with U.S. registrations for
esfenvalerate. This is because
fenvalerate uses are being phased out in
the United States. Esfenvalerate and
fenvalerate are considered chemically
and toxicologically equivalent by EPA.
Esfenvalerate is the S,S-isomer (the most
insecticidally active isomer) enriched
version of fenvalerate. Currently,
esfenvalerate tolerances in 40 CFR
180.533(a) are established for residues
of esfenvalerate, (S)-cyano(3phenoxyphenyl)methyl-(S)-4-chloro-a(1-methylethyl)benzeneacetate. The
Agency had determined that residues of
concern should include its non-racemic
isomer, (R)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and its
diastereomers (S)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and (R)cyano(3-phenoxyphenyl)methyl-(S)-4chloro-a-(1-methylethyl)benzeneacetate.
In addition, the Agency determined that
proposed and existing tolerances for
residues of concern as a result of
esfenvalerate use on food commodities
should be recodified into 40 CFR
180.533(a)(1) and separated from the
proposed tolerance on food
commodities for residues of concern as
a result of esfenvalerate use in foodhandling establishments. Therefore,
EPA is proposing to revise the
introductory text containing the
tolerance expression in 40 CFR
180.533(a) and recodify that section
under 40 CFR 180.533(a)(1), as follows:
‘‘Tolerances are established for the
combined residues of the insecticide
esfenvalerate, (S)-cyano(3phenoxyphenyl)methyl-(S)-4-chloro-a(1-methylethyl)benzeneacetate, its nonracemic isomer, (R)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and its
diastereomers (S)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and (R)cyano(3-phenoxyphenyl)methyl-(S)-4chloro-a-(1-methylethyl)benzeneacetate,
in or on food commodities as follows:.’’
In order to cover current registrations
for use of esfenvalerate in food-handling
establishments, EPA is proposing to
establish a tolerance of 0.05 ppm under
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newly recodified 40 CFR 180.533(a)(2)
on raw agricultural food commodities
(other than those food commodities
already covered by a higher tolerance as
a result of use on growing crops) for the
combined residues of the insecticide
esfenvalerate, (S)-cyano(3phenoxyphenyl)methyl-(S)-4-chloro-a(1-methylethyl)benzeneacetate, its nonracemic isomer, (R)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and its
diastereomers (S)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and (R)cyano(3-phenoxyphenyl)methyl-(S)-4chloro-a-(1-methylethyl)benzeneacetate.
Based on available data that showed
combined esfenvalerate residues of
concern that were non-detectable (<0.01
ppm) in or on sugar beet roots, and in
order to harmonize with the fenvalerate
Codex MRL for root and tuber
vegetables, EPA determined that the
tolerance should be decreased from 0.5
to 0.05 ppm. Therefore, EPA is
proposing to decrease the tolerance in
newly recodified 40 CFR 180.533(a)(1)
on beet, sugar, roots to 0.05 ppm. In
addition, based on available processing
data that showed an average
concentration factor of 4.5X for dried
sugar beet pulp and the highest average
field trial (HAFT) for sugar beet roots
(<0.01 ppm), EPA determined that the
expected combined esfenvalerate
residues of concern in dried sugar beet
pulp are <0.045 ppm. Because the
proposed tolerance for the raw
agricultural commodity (sugar beet root)
at 0.05 ppm should sufficiently cover
expected combined esfenvalerate
residues of concern in or on sugar beet
pulp resulting from registered use, the
Agency determined that the existing
tolerance on dried sugar beet pulp is no
longer needed and should be revoked.
Therefore, the Agency is proposing to
revoke the tolerance in newly recodified
40 CFR 180.533(a)(1) on beet, sugar,
dried pulp.
Because the existing tolerances for
kohlrabi and head lettuce support
regional registrations in Texas and
Arizona, California, Colorado, Florida,
New Mexico, and Texas, respectively,
EPA determined that these tolerances
are no longer general tolerances and
should be redesignated as regional
registrations. Therefore, the Agency is
proposing to recodify tolerances on
kohlrabi at 2.0 ppm and lettuce, head at
5.0 ppm from 40 CFR 180.533(a) into 40
CFR 180.533(c) for regional tolerances.
Also, because that section is currently
reserved, EPA is proposing introductory
text as follows: ‘‘Tolerances with
regional registration are established for
the combined residues of the insecticide
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esfenvalerate, (S)-cyano(3phenoxyphenyl)methyl-(S)-4-chloro-a(1-methylethyl)benzeneacetate, its nonracemic isomer, (R)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and its
diastereomers (S)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and (R)cyano(3-phenoxyphenyl)methyl-(S)-4chloro-a-(1-methylethyl)benzeneacetate,
in or on food commodities as follows:.’’
Currently, many crop commodities
registered for esfenvalerate, the S,Sisomer of fenvalerate, have been covered
by tolerances in 40 CFR 180.379 for
fenvalerate, a racemic mixture of four
stereoisomers (the S,S; R,S; S,R; and R,R
isomers). However, as described earlier
in this document, EPA is proposing to
revoke fenvalerate tolerances. Therefore,
EPA is proposing to establish separate
tolerances for esfenvalerate in 40 CFR
180.533 as described below.
Based on the available bridging data
from fenvalerate that compared residues
of fenvalerate with esfenvalerate for
certain crop commodities and using a
tiered approach of residue conversion,
EPA determined that fenvalerate
tolerances less than 1.0 ppm should be
established for esfenvalerate at levels
that remain unchanged due to the
increased variability in analytical data
as the limit of quantitation is
approached. Therefore, the Agency is
proposing to establish tolerances in
newly recodified 40 CFR 180.533(a)(1)
for combined esfenvalerate residues of
concern on almond at 0.2 ppm; bean,
dry, seed at 0.25 ppm; carrot, roots at
0.5 ppm; cauliflower at 0.5 ppm; corn,
field, grain at 0.02 ppm; corn, pop, grain
at 0.02 ppm; corn, sweet, kernel plus
cob with husks removed at 0.1 ppm;
cotton, undelinted seed at 0.2 ppm;
cucumber at 0.5 ppm; hazelnut at 0.2
ppm; lentil, seed at 0.25 ppm; pea, dry,
seed at 0.25 ppm; peanut at 0.02 ppm;
pecan at 0.2 ppm; potato at 0.02 ppm;
radish, roots at 0.3 ppm; soybean, seed
at 0.05 ppm; squash, summer at 0.5
ppm; turnip, roots at 0.5 ppm; and
walnut at 0.2 ppm.
Based on the available bridging data
from fenvalerate that compared residues
of fenvalerate with esfenvalerate for
certain crop commodities and using a
tiered approach of residue conversion,
EPA determined that fenvalerate
tolerances that range from 1.0 to 2.0
ppm should be established for
esfenvalerate at levels divided by 2.
Therefore, the Agency is proposing to
establish tolerances in newly recodified
40 CFR 180.533(a)(1) for combined
esfenvalerate residues of concern on
apple at 1.0 ppm; bean, snap, succulent
at 1.0 ppm; broccoli at 1.0 ppm;
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cantaloupe at 0.5 ppm; eggplant at 0.5
ppm; melon, honeydew at 0.5 ppm;
muskmelon at 0.5 ppm; pea, succulent
at 0.5 ppm; pear at 1.0 ppm; pepper at
0.5 ppm; pumpkin at 0.5 ppm; squash,
winter at 0.5 ppm; sugarcane, cane at
1.0 ppm; sunflower, seed at 0.5 ppm;
tomato at 0.5 ppm; and watermelon at
0.5 ppm.
Based on the available bridging data
from fenvalerate that compared residues
of fenvalerate with esfenvalerate for
certain crop commodities and using a
tiered approach of residue conversion,
EPA determined that fenvalerate
tolerances greater than 2.0 ppm should
be established for esfenvalerate at levels
divided by 3 and rounded to the nearest
whole number. Therefore, the Agency is
proposing to establish tolerances in
newly recodified 40 CFR 180.533(a)(1)
for combined esfenvalerate residues of
concern on almond, hulls at 5.0 ppm;
blueberry at 1.0 ppm; cabbage, except
chinese cabbage at 3.0 ppm; caneberry
subgroup 13A at 1.0 ppm; collards at 3.0
ppm; elderberry at 1.0 ppm; fruit, stone,
group 12 at 3.0 ppm; gooseberry at 1.0
ppm; radish, tops at 3.0 ppm; and
turnip, tops at 7.0 ppm.
Based on the available bridging data
from fenvalerate that compared residues
of fenvalerate with esfenvalerate for
corn and using a tiered approach of
residue conversion, the Agency
determined that tolerances should be
established for combined esfenvalerate
residues of concern on the forage of
field and sweet corn and the stover of
field, pop, and sweet corn, each at 15.0
ppm. Therefore, the Agency is
proposing to establish tolerances in
newly recodified 40 CFR 180.533(a)(1)
for combined esfenvalerate residues of
concern on corn, field, forage at 15.0
ppm; corn, field, stover at 15.0 ppm;
corn, pop, stover at 15.0 ppm; corn,
sweet, forage at 15.0 ppm; and corn,
sweet, stover at 15.0 ppm.
In order to cover potential secondary
residues in or on milk and ruminant
tissues which could result from
registered uses of esfenvalerate on many
livestock feed items and livestock
premises, and because the ruminant
metabolism of esfenvalerate is similar to
fenvalerate, EPA determined that animal
commodity tolerances for esfenvalerate
should be established at levels which
match the existing tolerances for
fenvalerate. Therefore, the Agency is
proposing to establish tolerances in 40
CFR 180.533(a)(1) on cattle, fat; cattle,
meat; cattle, meat byproducts; goat, fat;
goat, meat; goat, meat byproducts; hog,
fat; hog, meat; hog, meat byproducts;
horse, fat; horse, meat; horse, meat
byproducts; sheep, fat; sheep, meat; and
sheep, meat byproducts; each at 1.5
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ppm; in milk at 0.3 ppm; and in milk,
fat at 7.0 ppm.
Based on a petition with data
submitted by the Interregional Research
Project No. 4 (IR-4) in support of the use
of esfenvalerate on sweet potatoes that
showed residues of concern at <0.05
ppm, EPA determined that a tolerance
should be established at 0.05 ppm.
Therefore, the Agency is proposing to
establish a tolerance in 40 CFR
180.533(a)(1) on sweet potato, roots at
0.05 ppm.
Also, based on a petition with data
submitted by IR-4 in support of a
regional registration (east of the
Mississippi River only) for use of
esfenvalerate on bok choy that showed
residues of concern at <1.0 ppm, EPA
determined that a regional tolerance
should be established at 1.0 ppm.
Therefore, the Agency is proposing to
establish a regional tolerance in 40 CFR
180.533(c) on cabbage, chinese, bok
choy at 1.0 ppm.
In addition, based on a petition with
data submitted by IR-4 regarding bulk
food storage areas and in support of
postharvest uses of esfenvalerate on
stored almonds, cacao beans, peanuts,
and walnuts that showed residues of
concern as high as 43.48 ppm, 0.79
ppm, 0.11 ppm and 13.05 ppm,
respectively, on samples collected from
exposed surface sections of sacks
(samples from interior sections of sacks
were mostly non-detectable; i.e., <0.1
ppm), EPA determined that postharvest
tolerances should be established on
almond, postharvest at 50 ppm; cacao
bean, postharvest at 1.0 ppm; peanut,
postharvest at 0.20 ppm; and walnut,
postharvest at 15 ppm. However, the
petitioner needs to submit a revised
Section B to limit number of
consecutive daily spray applications to
270 days and specify a retreatment
interval of 3-4 days when the proposed
formulation is used for space treatments
of food-handling establishments other
than on stored almonds, cacao beans,
peanuts, and walnuts. Therefore, the
Agency is not taking action to establish
such postharvest tolerances at this time.
Moreover, based on a petition with
data submitted by IR-4 in support of a
regional registration (for use of
esfenvalerate on Brussels sprouts grown
in all states except California) that
showed esfenvalerate residues of
concern as high as 0.141 ppm, EPA
determined that a postharvest tolerance
should be established at 0.20 ppm.
Provided that the use of esfenvalerate on
Brussels sprouts is limited to the EPAdefined growing regions represented by
Arkansas (Region 4) and North Carolina
(Region 2), no additional field trials are
required. However, the petitioner did
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not specify the minimum spray volumes
for ground versus aerial equipment
applications, and this information is
required since the amount of spray
volumes as well as equipment types can
affect the magnitude of residues.
Therefore, the Agency is not taking
action to establish such a tolerance for
Brussels sprouts at this time.
There are Codex MRLs for residues of
esfenvalerate on eggs; poultry meat; and
poultry, edible offal.
4. Ethylene oxide. Because there are
no active registrations for use of
ethylene oxide on coconut, EPA
determined that the tolerance on
coconut, copra is no longer needed and
should be revoked. Consequently, the
Agency is proposing to revoke the
tolerance in 40 CFR 180.151(a) on
coconut, copra.
EPA has determined that the tolerance
on processed spices at 50 ppm in 40
CFR 180.151(a)(2) should be reassigned
with the tolerance on whole spices at 50
ppm in 40 CFR 180.151(a)(1), as one
tolerance termed herbs and spices,
group 19, dried (except basil), and
should be lowered to 7 ppm based on
a reevaluation of a single chamber
process that showed much lower
residue levels. Therefore, the Agency is
proposing to revoke the tolerances on
processed (ground) spices in 40 CFR
180.151(a)(2) and the tolerance on
spices, whole in 40 CFR 180.151(a)(1),
and establish a tolerance in 40 CFR
180.151(a)(1) on herb and spice, group
19, dried, except basil at 7 ppm.
Based on data for spices/herbs and
single chamber treatment process, EPA
determined that a tolerance should be
established on dried vegetables at 7
ppm, provided that label amendments
are made as described above. Therefore,
the Agency is proposing to establish a
tolerance in 40 CFR 180.151(a)(1) for
residues of ethylene oxide in or on
vegetable, dried at 7 ppm.
Currently in 40 CFR 180.151(a)(2),
there are prescribed conditions of use
for ethylene oxide. The Agency believes
that these current sections in 40 CFR
180.151(a)(2) should be removed
because all treatment parameters should
be on the label. Ethylene chlorohydrin
is a reaction product that results from
the fumigation of foods with ethylene
oxide due to interaction of the ethylene
oxide with natural chlorides present in
the crop. Based on spice sterilization
data and a refined probabilistic acute
dietary assessment for all supported
ethylene oxide food uses, the Agency
concluded that ethylene chlorohydrin is
a residue of concern and should have
tolerances. Therefore, EPA is proposing
to remove existing paragraph (a)(2) and
establish a tolerance expression in
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newly revised 40 CFR 180.151(a)(2) as
follows: ‘‘Tolerances are established for
residues of the ethylene oxide reaction
product, 2-chloroethanol, commonly
referred to as ethylene chlorohydrin,
when ethylene oxide is used as a
postharvest fumigant in or on food
commodities as follows:.’’
Also, EPA is proposing to establish
tolerances in 40 CFR 180.151(a)(2) for
ethylene chlorohydrin on herb and
spice, group 19, dried, except basil at
940 ppm and vegetable, dried at 940
ppm.
In addition, EPA is proposing to
revise commodity terminology to
conform to current Agency practice as
follows: in 40 CFR 180.151(a)(1),
‘‘walnut, black’’ to ‘‘walnut.’’
There are no Codex MRLs for residues
of ethylene oxide or ethylene
chlorohydrin in or on spices/herbs. A
Canadian MRL exists for ethylene
chlorohydrin on spices at 1,500 ppm.
There is no Canadian MRL for ethylene
oxide on spices/herbs. However,
because the U.S. residue data showed
slightly lower levels of ethylene
chlorohydrin, the Agency is proposing a
940 ppm tolerance.
5. Fenvalerate. Fenvalerate is a
racemic mixture of four stereoisomers
(the S,S; R,S; S,R; and R,R isomers). On
August 5, 2004 (69 FR 47437) (FRL–
7369–5), EPA issued a cancellation
order for all technical registrations for
fenvalerate that permitted one technical
registrant to sell and distribute existing
stocks until March 27, 2004 and the
other technical registrant to sell and
distribute existing stocks until April 1,
2004. Since then, in the Federal
Register of April 30, 2008 (73 FR 23457)
(FRL–8363–5), EPA issued a notice
regarding EPA’s announcement of the
receipt of requests from end-use
registrants to voluntarily cancel certain
registrations for fenvalerate, cyano(3phenoxyphenyl)methyl-4-chloro-a-(1methylethyl)benzeneacetate, which
would terminate the last fenvalerate
products registered for use in the United
States. EPA approved the cancellations
effective on July 9, 2008, and permitted
the registrants to sell and distribute
product under the previously approved
labeling for a period of 1 year from the
date of the cancellation request (which
ranged from August 29, 2007 through
April 2, 2008), i.e., until April 2, 2009
for the last end-use registrations. These
last registrations were for uses
associated with agricultural, pet care,
domestic home and garden, and
commercial/industrial/food sites and
non-food/mosquito abatement. The
Agency believes that end users will
have had sufficient time to exhaust
existing stocks and for the fenvalerate-
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treated food commodities to have
cleared the channels of trade by April 2,
2010. Therefore, EPA is proposing to
revoke the tolerances in 40 CFR
180.379(a)(1) on almond, hulls; almond;
apple; artichoke, globe; bean, dry, seed;
bean, snap, succulent; broccoli;
blueberry; cabbage; caneberry subgroup
13A; cantaloupe; carrot, roots; cattle, fat;
cattle, meat byproducts; cattle, meat;
cauliflower; collards; corn, grain; corn,
forage; corn, stover; corn, sweet, kernel
plus cob with husks removed; cotton,
undelinted seed; cucumber; currant;
eggplant; elderberry; fruit, stone; goat,
fat; goat, meat byproducts; goat, meat;
gooseberry; hazelnut; hog, fat; hog meat
byproducts; hog, meat; horse, fat; horse,
meat byproducts; horse, meat;
huckleberry; melon, honeydew; milk;
milk, fat; muskmelon; peanut; pear; pea;
pea, dry, seed; pecan; pepper; potato;
pumpkin; radish, roots; radish, tops;
sheep, fat; sheep, meat byproducts;
sheep, meat; soybean; squash, summer;
squash, winter; sugarcane, cane;
sunflower, seed; tomato; turnip, greens;
turnip, roots; walnut; and watermelon;
each with an expiration/revocation date
of April 2, 2010. Also, EPA is proposing
to revoke the tolerance in 40 CFR
180.379(a)(3) on soybean, hulls and the
regional tolerance in 40 CFR 180.379(c)
on okra. In addition, EPA is proposing
to revoke a tolerance on raw agricultural
food commodities (other than those food
commodities already covered by a
higher tolerance as a result of use on
growing crops) at 0.05 ppm in 40 CFR
180.379(a)(2) for residues of fenvalerate
and esfenvalerate as a result of use in
food-handling establishments. A
separate tolerance for use of
esfenvalerate in food-handling
establishments is proposed by the
Agency to be established in 40 CFR
180.533(a)(2) as described earlier in this
document.
Due to the proposed tolerance
revocations herein, EPA is proposing to
revise the section heading in 40 CFR
180.379 from cyano(3phenoxyphenyl)methyl-4-chloro-a-(1methylethyl)benzeneacetate to that of
fenvalerate, remove the table in
paragraph (c) and reserve paragraph (c),
remove paragraphs (a)(2) and (a)(3),
revise paragraph (a)(1) into (a) and the
introductory text containing the
tolerance expression in newly
recodified 40 CFR 180.379(a) to read as
follows: ‘‘Tolerances are established for
residues of the insecticide fenvalerate,
cyano(3-phenoxyphenyl)methyl-4chloro-a-(1-methylethyl)benzeneacetate,
in or on food commodities as follows.’’
Also, EPA is proposing to revise
commodity terminology to conform to
current Agency practice in 40 CFR
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180.379(a) from ‘‘corn, forage’’ to ‘‘corn,
field, forage’’ and ‘‘corn, sweet, forage;’’
‘‘corn, grain’’ to ‘‘corn, field, grain’’ and
‘‘corn, pop, grain;’’ ‘‘corn, stover’’ to
‘‘corn, field, stover,’’ ‘‘corn, pop,
stover,’’ and ‘‘corn, sweet, stover;’’
‘‘fruit, stone’’ to ‘‘fruit, stone, group 12;’’
‘‘soybean’’ to ‘‘soybean, seed;’’ and
‘‘turnip, greens’’ to ‘‘turnip, tops.’’
Currently, there are existing Codex
MRLs for fenvalerate residues on beans,
shelled at 0.1 mg/kg; beans, except
broad bean and soya bean at 1 mg/kg;
berries and other small fruits at 1 mg/
kg; broccoli at 2 mg/kg; cabbages, head
at 3 mg/kg; cauliflower at 2 mg/kg;
cereal grains at 2 mg/kg; cherries at 2
mg/kg; cottonseed at 0.2 mg/kg;
cucumber at 0.2 mg/kg; edible offal
(mammalian) at 0.02 mg/kg; fat of meat
(from mammals other than marine
mammals) at 1 mg/kg; melons, except
watermelon at 0.2 mg/kg; milks at 0.1
mg/kg; peach at 5 mg/kg; peanut, whole
at 0.1 mg/kg; peas, shelled (succulent
seeds) at 0.1 mg/kg; peppers, chili (dry)
at 5 mg/kg; peppers, sweet at 0.5 mg/kg;
pome fruits at 2 mg/kg; root and tuber
vegetables at 0.05 mg/kg; soya bean
(dry) at 0.1 mg/kg; squash, summer at
0.5 mg/kg; sunflower seed at 0.1 mg/kg;
sweet corn (corn-on-the-cob) at 0.1 mg/
kg; tomato at 1 mg/kg; watermelon at 0.5
mg/kg; tree nuts at 0.2 mg/kg; and
winter squash at 0.5 mg/kg.
6. 1-Naphthaleneacetic acid.
Currently, tolerances in 40 CFR
180.155(a) are established for residues
of 1-naphthaleneacetic acid, in 40 CFR
180.155(b) for residues of the ethyl ester
of 1-naphthaleneacetic acid, and in 40
CFR 180.309 for combined residues of
a-naphthaleneacetamide and its
metabolite a-naphthaleneacetic acid
(calculated as a-naphthaleneacetic
acid). However, the Agency has
determined the residues of concern are
1-naphthaleneacetic acid and its
conjugates and therefore that the
introductory text in 40 CFR 180.155(a)
should be revised for residues of 1naphthaleneacetic acid and its
conjugates calculated as 1naphthaleneacetic acid that result from
application of the acid, its ammonium,
sodium, or potassium salts, ethyl ester,
or acetamide. Therefore, while
tolerances on apple, pear, and olive
should be proposed at reassessed levels
in 40 CFR 180.155(a), separate
tolerances on apple, pear, and olive in
40 CFR 180.155(b) and on apple and
pear in 40 CFR 180.309 are no longer
needed and should be revoked.
Consequently, EPA is proposing to
revoke the tolerances on apple, pear,
and olive in 40 CFR 180.155(b) and
revise and reserve that paragraph for
tolerances with section 18 emergency
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exemptions. Also, EPA is proposing to
revoke the tolerances on apple and pear
in 40 CFR 180.309, and remove that
section. In addition, EPA is proposing to
revise the introductory text in 40 CFR
180.155(a) as follows: ‘‘Tolerances are
established for the combined residues of
the plant growth regulator 1naphthaleneacetic acid and its
conjugates calculated as 1naphthaleneacetic acid from the
application of 1-naphthaleneacetic acid,
its ammonium, sodium, or potassium
salts, ethyl ester, and acetamide in or on
food commodities as follows:.’’
Because tolerances for residues of 1naphthaleneacetic acid by application of
its various forms will be combined into
one introductory text in 40 CFR
180.155(a), 40 CFR 180.3(d)(7), which
states that the total amount of residues
for a-naphthaleneacetamide and/or anaphthaleneacetic acid on the same raw
agricultural commodity shall not exceed
more residue than that permitted by the
higher of the two tolerances, is no
longer needed and therefore 40 CFR
180.3(d)(7) should be removed.
Consequently, EPA is proposing to
remove the current 40 CFR 180.3(d)(7)
and redesignate current 40 CFR
180.3(d)(8) through (d)(13) as 40 CFR
180.3(d)(7) through (d)(12), respectively.
Based on available field trial data that
showed combined naphthaleneacetic
acid residues of concern in or on apples
and pears as high as 0.06 ppm and 0.03
ppm, respectively, EPA determined that
the tolerances on apple, pear, and
quince in 40 CFR 180.155(a) should be
decreased from 1 to 0.1 ppm and revised
into a crop group tolerance entitled
fruit, pome, group 11. Therefore, EPA is
proposing to decrease the tolerances on
apple, pear, and quince in 40 CFR
180.155(a) to 0.1 ppm and revise them
into fruit, pome, group 11.
Based on available field trial data that
showed combinednaphthaleneacetic
acid residues of concern in or on olives
as high as 0.61 ppm, EPA determined
that the tolerances on olive in 40 CFR
180.155(a) should be increased from 0.1
to 0.7 ppm. Therefore, EPA is proposing
to increase the tolerance on olive in 40
CFR 180.155(a) to 0.7 ppm. The Agency
determined that the increased tolerance
is safe; i.e., there is a reasonable
certainty that no harm will result from
aggregate exposure to the pesticide
chemical residue. Also, EPA is
proposing to remove the ‘‘(N)’’
designation from the tolerance on olive
in 40 CFR 180.155(a) to conform to
current Agency administrative practice,
where the ‘‘(N)’’ designation means
negligible residue.
Also, in accordance with current
Agency practice, EPA is proposing to
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revise 40 CFR 180.155 by adding
separate paragraphs (c), and (d), and
reserving those sections for tolerances
with regional registrations and indirect
or inadvertent residues, respectively.
In addition, EPA is proposing to
revise commodity terminology to
conform to current Agency practice in
40 CFR 180.155(a) from ‘‘orange, sweet’’
to ‘‘orange.’’ Also, in order to reflect that
there are no U.S. registrations, but only
support for importation, EPA is
proposing to footnote the pineapple
tolerance and revise it from ‘‘pineapple
(from the application of the sodium salt
to the growing crop)’’ to ‘‘pineapple.’’
There are no Codex MRLs for residues
of 1-naphthaleneacetic acid, its salts,
ester, and acetamide.
7. Phosalone. In the Federal Register
of October 26, 1998 (63 FR 57062) (FRL–
6035–8), EPA responded to a comment
from Rhone-Poulenc Ag Company,
which requested that the Agency not
revoke tolerances for phosalone on
almonds; apricots; apples; cherries;
grapes; peaches; pears; and plums/
prunes in order to maintain them for
importation purposes, by not revoking
those tolerances at that time. Later, after
a merger, Rhone-Poulenc Ag Company
became Aventis CropScience, and was
eventually acquired by Bayer
CropScience, which later entered into
an agreement that transferred the global
rights of phosalone to Cheminova. On
April 30, 2008, Cheminova notified EPA
that for commercial reasons it will not
develop the requested data to support
the phosalone import tolerances.
However, Cheminova urged the Agency
to prevent trade irritants and consider
that Canada is phasing out the use of
phosalone. Health Canada’s Pest
Management Regulatory Agency
(PMRA) has scheduled a last date of
application for phosalone on apple;
cherry; grape; peach; pear; and plum/
prune as September 30, 2012, with the
earliest date for amending (revoking) its
MRLs as September 30, 2013. This
information is found on PMRA’s
website at https://www.pmra-arla.gc.ca/
english/pdf/rev/rev2008-02-e.pdf.
Therefore, EPA is proposing to revoke
the tolerances in 40 CFR 180.263 on
apple; cherry; grape; peach; pear; and
plum, prune, fresh; each with an
expiration date of September 30, 2013.
In addition, EPA is proposing to revoke
the tolerances in 40 CFR 180.263 on
almond and apricot effective on the day
of publication of the final rule in the
Federal Register.
In accordance with current Agency
practice, EPA is proposing to revise 40
CFR 180.263 by adding separate
paragraphs (b), (c), and (d), and
reserving those sections for tolerances
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with section 18 emergency exemptions,
regional registrations, and indirect or
inadvertent residues, respectively.
There are Codex MRLs for residues of
phosalone on almonds, pome fruits, and
stone fruits.
8. Phosmet, N(Mercaptomethyl)phthalimide S-(O,Odimethyl phosphorodithioate). Based on
metabolism and cattle feeding data
(0.2X (MTDB) that showed combined
phosmet residues of concern in milk
below the limit of quantitation (LOQ) of
0.05 ppm, EPA determined that a
tolerance should be established on milk
for phosmet residues of concern at the
combined LOQ level of 0.1 ppm.
Therefore, EPA is proposing to establish
a tolerance on milk in 40 CFR
180.261(a) at 0.1 ppm.
Based on available metabolism and
cattle feeding data (1.1X MTDB) that
showed combined phosmet residues of
concern in or on meat and meat
byproducts below the LOQ of 0.05 ppm,
EPA determined that the tolerances on
meat and meat byproducts of cattle,
goats, horses, and sheep should be set
at the combined LOQ of 0.1 ppm, and
therefore decreased from 0.2 to 0.1 ppm.
Consequently, EPA is proposing to
decrease tolerances in 40 CFR
180.261(a) on cattle, meat; goat, meat;
horse, meat; sheep, meat; cattle, meat
byproducts; goat, meat byproducts;
horse, meat byproducts; and sheep,
meat byproducts, each to 0.1 ppm.
Based on a slightly exaggerated
dermal application, EPA determined
that combined phosmet residues of
concern in or on cattle fat were below
the combined LOQ and in order to
reflect both secondary residues from
feed and direct dermal application, the
Agency determined that overall
combined residues in or on cattle fat are
expected to be <0.2 ppm. However,
phosmet is not registered for dermal
application to goats, horses, and sheep,
and the fat tolerances on goats, horses
and sheep should be based on the cattle
feeding data alone and set at a combined
LOQ of 0.1 ppm, and therefore
decreased from 0.2 to 0.1 ppm.
Consequently, EPA is proposing to
decrease the tolerances in 40 CFR
180.261(a) on goat, fat; horse, fat; and
sheep, fat to 0.1 ppm.
Based on swine dermal treatment data
that showed combined phosmet
residues of concern in or on liver,
kidney, and muscle from animals at the
1–day pre-slaughter interval, each below
the combined LOQ of 0.04 ppm, EPA
determined that the tolerances on meat
and meat byproducts of hogs should be
decreased from 0.2 to 0.04 ppm.
Consequently, EPA is proposing to
decrease tolerances in 40 CFR
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180.261(a) on hog, meat; and hog, meat
byproducts, each to 0.04 ppm.
Based on available storage stability
data that showed no significant decline
in residues after 343 days of freezer
storage and field trial data that showed
combined phosmet residues of concern
in or on washed sweet potatoes as high
as 11.2 ppm following postharvest
treatment and 40–day storage, EPA
determined that the tolerance on sweet
potatoes should be increased from 10 to
12 ppm. Therefore, EPA is proposing to
increase the tolerance in 40 CFR
180.261(a) on sweet potato, roots to 12
ppm. The Agency determined that the
increased tolerance is safe; i.e., there is
a reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue.
Based on available field trial data that
showed combined phosmet residues of
concern in or on succulent pea pods,
and dry pea hay as high as 0.56 ppm
and 17.3 ppm, respectively, EPA
determined that the tolerance on field
pea hay should be increased from 10 to
20 ppm, and the pea tolerance at 0.5
ppm should be revised and divided into
pea, dry, seed at 0.5 ppm and pea,
succulent, which should be increased
from 0.5 to 1 ppm. Therefore, EPA is
proposing in 40 CFR 180.261(a) to
increase the tolerance on pea, field, hay
to 20 ppm and revise pea into pea, dry,
seed at 0.5 ppm and pea, succulent at
1 ppm. The Agency determined that the
increased tolerances are safe; i.e., there
is a reasonable certainty that no harm
will result from aggregate exposure to
the pesticide chemical residue.
Based on available field trial data that
showed combined phosmet residues of
concern below 20 ppm on alfalfa forage,
EPA determined that the tolerance on
alfalfa at 40 ppm should be revised and
divided into alfalfa, hay at 40 ppm and
alfalfa, forage, which should be
decreased from 40 to 20 ppm. Therefore,
EPA is proposing to revise the tolerance
in 40 CFR 180.261(a) on alfalfa into
alfalfa, hay at 40 ppm and alfalfa, forage
at 20 ppm.
Based on available processing data for
cotton that showed phosmet residues of
concern concentrated in cottonseed oil
at 2X the treatment of cotton, EPA
determined that a tolerance of 0.2 ppm
should be established based on the
existing tolerance of 0.1 ppm for cotton,
undelinted seed. Therefore, EPA is
proposing to establish a tolerance in 40
CFR 180.261(a) on cotton, refined oil at
0.2 ppm.
Also, EPA is proposing to revise
commodity terminology to conform to
current Agency practice in 40 CFR
180.261(a) from ‘‘fruit, citrus’’ to ‘‘fruit,
citrus, group 10’’ and ‘‘nut’’ to ‘‘nut,
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tree, group 14.’’ Moreover, in 40 CFR
180.261, EPA is proposing to remove the
‘‘(N)’’ designation from all entries to
conform to current Agency
administrative practice, where the ‘‘(N)’’
designation means negligible residues.
There is compatibility between U.S.
tolerances and Codex MRLs for residues
of phosmet on apple at 10 mg/kg;
apricot at 5 mg/kg; blueberries at 10 mg/
kg; citrus fruits at 5 mg/kg; grapes at 10
mg/kg; nectarine at 5 mg/kg; peach at 10
mg/kg; pear at 10 mg/kg. In addition,
there are Codex MRLs for residues of
phosmet on tree nuts at 0.2 mg/kg and
potato at 0.05 mg/kg.
9. Primisulfuron-methyl. There have
been no active registrations for use of
primisulfuron-methyl on sweet corn for
more than 10 years. Also, for at least 10
years, active registrations for
primisulfuron-methyl have shown a
label prohibition of its use on sweet
corn. Therefore, there is no longer a
need for the sweet corn tolerance.
Consequently, EPA is proposing to
revoke the tolerance in 40 CFR 180.452
on corn, sweet, kernel plus cob with
husks removed.
There are no Codex MRLs for residues
of primisulfuron-methyl.
10. Prothioconazole. Prothioconazole
is a fungicide first registered for use in
the United States in 2007. Therefore, it
did not need to be reviewed under the
reregistration or tolerance reassessment
programs. However, current active
registrations for the use of
prothioconazole on peanuts have a label
restriction against the feeding of peanut
hay or threshings to livestock or grazing
of livestock in treated areas. Based on
these restrictions, the Agency has
determined that the tolerance on peanut
hay is no longer needed, and therefore
should be revoked. Consequently, EPA
is proposing to revoke the tolerance in
40 CFR 180.626(a)(1) on peanut, hay.
There are no Codex MRLs for residues
of prothioconazole.
11. Thiabendazole. In the Federal
Register of December 28, 2007 (72 FR
73809) (FRL–8345–5), EPA issued a
notice regarding EPA’s announcement
of the receipt of requests from
registrants to voluntarily amend certain
registrations for several active
ingredients, including deletion of the
last sugar beet uses from thiabendazole
registrations. EPA approved the sugar
beet use deletions for thiabendazole and
made the last one effective on June 25,
2008, and permitted the registrants to
sell and distribute product under the
previously approved labeling for a
period of 18 months after approval of
the revision; i.e., until December 25,
2009. The Agency believes that end
users will have had sufficient time to
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exhaust existing stocks and for
thiabendazole-treated sugar beet
commodities to have cleared the
channels of trade by December 25, 2010.
Therefore, EPA is proposing to revoke
the tolerances in 40 CFR 180.242(a)(1)
on beet, sugar, dried pulp; beet, sugar,
roots; and beet, sugar, tops; each with an
expiration/revocation date of December
25, 2010.
There are no Codex MRLs for residues
of thiabendazole on sugar beets.
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B. What is the Agency’s Authority for
Taking this Action?
A ‘‘tolerance’’ represents the
maximum level for residues of pesticide
chemicals legally allowed in or on raw
agricultural commodities and processed
foods. Section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA of 1996,
Public Law 104–170, authorizes the
establishment of tolerances, exemptions
from tolerance requirements,
modifications in tolerances, and
revocation of tolerances for residues of
pesticide chemicals in or on raw
agricultural commodities and processed
foods. Without a tolerance or
exemption, food containing pesticide
residues is considered to be unsafe and
therefore ‘‘adulterated’’ under section
402(a) of FFDCA, 21 U.S.C. 342(a). Such
food may not be distributed in interstate
commerce (21 U.S.C. 331(a)). For a fooduse pesticide to be sold and distributed,
the pesticide must not only have
appropriate tolerances under the
FFDCA, but also must be registered
under FIFRA (7 U.S.C. 136 et seq.).
Food-use pesticides not registered in the
United States must have tolerances in
order for commodities treated with
those pesticides to be imported into the
United States.
EPA is proposing these tolerance
actions to implement the tolerance
recommendations made during the
reregistration and tolerance
reassessment processes (including
follow-up on canceled or additional
uses of pesticides). As part of these
processes, EPA is required to determine
whether each of the amended tolerances
meets the safety standard of FQPA. The
safety finding determination is
discussed in detail in each post-FQPA
RED and TRED for the active ingredient.
REDs and TREDs recommend the
implementation of certain tolerance
actions, including modifications to
reflect current use patterns, to meet
safety findings, and change commodity
names and groupings in accordance
with new EPA policy. Printed and
electronic copies of the REDs and
TREDs are available as provided in Unit
II.A.
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EPA has issued REDs for azinphosmethyl, disulfoton, 1-naphthaleneacetic
acid, phosmet, and thiabendazole, and
TREDs for ethylene oxide and
primisulfuron methyl. REDs and TREDs
contain the Agency’s evaluation of the
database for these pesticides, including
requirements for additional data on the
active ingredients to confirm the
potential human health and
environmental risk assessments
associated with current product uses,
and in REDs state conditions under
which these uses and products will be
eligible for reregistration. The REDs and
TREDs recommended the establishment,
modification, and/or revocation of
specific tolerances. RED and TRED
recommendations such as establishing
or modifying tolerances, and in some
cases revoking tolerances, are the result
of assessment under the FFDCA
standard of ‘‘reasonable certainty of no
harm.’’ However, tolerance revocations
recommended in REDs and TREDs that
are proposed in this document do not
need such assessment when the
tolerances are no longer necessary.
EPA’s general practice is to propose
revocation of tolerances for residues of
pesticide active ingredients on crops for
which FIFRA registrations no longer
exist and on which the pesticide may
therefore no longer be used in the
United States. EPA has historically been
concerned that retention of tolerances
that are not necessary to cover residues
in or on legally treated foods may
encourage misuse of pesticides within
the United States. Nonetheless, EPA
will establish and maintain tolerances
even when corresponding domestic uses
are canceled if the tolerances, which
EPA refers to as ‘‘import tolerances,’’ are
necessary to allow importation into the
United States of food containing such
pesticide residues. However, where
there are no imported commodities that
require these import tolerances, the
Agency believes it is appropriate to
revoke tolerances for unregistered
pesticides in order to prevent potential
misuse.
Furthermore, as a general matter, the
Agency believes that retention of import
tolerances not needed to cover any
imported food may result in
unnecessary restriction on trade of
pesticides and foods. Under section 408
of FFDCA, a tolerance may only be
established or maintained if EPA
determines that the tolerance is safe
based on a number of factors, including
an assessment of the aggregate exposure
to the pesticide and an assessment of
the cumulative effects of such pesticide
and other substances that have a
common mechanism of toxicity. In
doing so, EPA must consider potential
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
80327
contributions to such exposure from all
tolerances. If the cumulative risk is such
that the tolerances in aggregate are not
safe, then every one of these tolerances
is potentially vulnerable to revocation.
Furthermore, if unneeded tolerances are
included in the aggregate and
cumulative risk assessments, the
estimated exposure to the pesticide
would be inflated. Consequently, it may
be more difficult for others to obtain
needed tolerances or to register needed
new uses. To avoid potential trade
restrictions, the Agency is proposing to
revoke tolerances for residues on crops
uses for which FIFRA registrations no
longer exist, unless someone expresses
a need for such tolerances. Through this
proposed rule, the Agency is inviting
individuals who need these import
tolerances to identify themselves and
the tolerances that are needed to cover
imported commodities.
Parties interested in retention of the
tolerances should be aware that
additional data may be needed to
support retention. These parties should
be aware that, under FFDCA section
408(f), if the Agency determines that
additional information is reasonably
required to support the continuation of
a tolerance, EPA may require that
parties interested in maintaining the
tolerances provide the necessary
information. If the requisite information
is not submitted, EPA may issue an
order revoking the tolerance at issue.
When EPA establishes tolerances for
pesticide residues in or on raw
agricultural commodities, consideration
must be given to the possible residues
of those chemicals in meat, milk,
poultry, and/or eggs produced by
animals that are fed agricultural
products (for example, grain or hay)
containing pesticides residues (40 CFR
180.6). When considering this
possibility, EPA can conclude that:
1. Finite residues will exist in meat,
milk, poultry, and/or eggs.
2. There is a reasonable expectation
that finite residues will exist.
3. There is a reasonable expectation
that finite residues will not exist. If
there is no reasonable expectation of
finite pesticide residues in or on meat,
milk, poultry, or eggs, tolerances do not
need to be established for these
commodities (40 CFR 180.6(b) and (c)).
EPA has evaluated certain specific
meat, milk, poultry, and egg tolerances
proposed for revocation in this
document and has concluded that there
is no reasonable expectation of finite
pesticide residues of concern in or on
those commodities.
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C. When Do These Actions Become
Effective?
With the exception of certain
tolerances for azinphos-methyl,
disulfoton, fenvalerate, phosalone, and
thiabendazole for which EPA is
proposing specific expiration/revocation
dates, the Agency is proposing that
these revocations, modifications,
establishments of tolerances, and
revisions of tolerance nomenclature
become effective on the date of
publication of the final rule in the
Federal Register. With the exception of
the proposed revocation of specific
tolerances for azinphos-methyl,
disulfoton, fenvalerate, phosalone, and
thiabendazole, the Agency believes that
existing stocks of pesticide products
labeled for the uses associated with the
tolerances proposed for revocation have
been completely exhausted and that
treated commodities have cleared the
channels of trade. EPA is proposing
expiration/revocation dates of October
30, 2009, for azinphos-methyl tolerances
on almond; almond, hulls; pistachio;
and walnut; September 30, 2012, for
azinphos-methyl tolerances on apple;
crabapple; blueberry; cherry; parsley,
leaves; parsley, turnip rooted, roots; and
pear; October 14, 2009, for disulfoton
tolerances on spinach and tomato;
January 30, 2010, for disulfoton
tolerances on barley, grain; barley,
straw; grain, aspirated fractions; peanut;
pepper; potato; wheat, hay; wheat,
grain; wheat, straw; milk; and the fat,
meat, and meat byproducts of cattle,
goats, hogs, horses, and sheep; April 2,
2010, for most of the fenvalerate
tolerances (as described in Unit II.A.);
September 30, 2013, for phosalone
tolerances on apple; cherry; grape;
peach; pear; and plum, prune, fresh; and
December 25, 2010, for thiabendazole
tolerances on beet, sugar, dried pulp;
beet, sugar, roots; and beet, sugar, tops.
The Agency believes that these
revocation dates allow users to exhaust
stocks and allows sufficient time for
passage of treated commodities through
the channels of trade. However, if EPA
is presented with information that
existing stocks would still be available
and that information is verified, the
Agency will consider extending the
expiration date of the tolerance. If you
have comments regarding existing
stocks and whether the effective date
allows sufficient time for treated
commodities to clear the channels of
trade, please submit comments as
described under SUPPLEMENTARY
INFORMATION.
Any commodities listed in this
proposal treated with the pesticides
subject to this proposal, and in the
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17:24 Dec 30, 2008
Jkt 217001
channels of trade following the
tolerance revocations, shall be subject to
FFDCA section 408(l)(5), as established
by FQPA. Under this unit, any residues
of these pesticides in or on such food
shall not render the food adulterated so
long as it is shown to the satisfaction of
the Food and Drug Administration that:
1. The residue is present as the result
of an application or use of the pesticide
at a time and in a manner that was
lawful under FIFRA, and
2. The residue does not exceed the
level that was authorized at the time of
the application or use to be present on
the food under a tolerance or exemption
from tolerance. Evidence to show that
food was lawfully treated may include
records that verify the dates when the
pesticide was applied to such food.
III. Are the Proposed Actions
Consistent with International
Obligations?
The tolerance actions in this proposal
are not discriminatory and are designed
to ensure that both domestically
produced and imported foods meet the
food safety standards established by
FFDCA. The same food safety standards
apply to domestically produced and
imported foods.
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international MRLs established by the
Codex Alimentarius is a joint U.N. Food
and Agriculture Organization/World
Health Organization food standards
program, and it is recognized as an
international food safety standardssetting organization in trade agreements
to which the United States is a party.
EPA may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level in a notice
published for public comment. EPA’s
effort to harmonize with Codex MRLs is
summarized in the tolerance
reassessment section of individual REDs
and TREDs, and in the Residue
Chemistry document which supports
the RED and TRED, as mentioned in
Unit II.A. Specific tolerance actions in
this proposed rule and how they
compare to Codex MRLs (if any) are
discussed in Unit II.A.
IV. Statutory and Executive Order
Reviews
In this proposed rule, EPA is
proposing to establish tolerances under
FFDCA section 408(e), and also modify
and revoke specific tolerances
PO 00000
Frm 00016
Fmt 4702
Sfmt 4702
established under FFDCA section 408.
The Office of Management and Budget
(OMB) has exempted these types of
actions (e.g., establishment and
modification of a tolerance and
tolerance revocation for which
extraordinary circumstances do not
exist) from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this proposed
rule has been exempted from review
under Executive Order 12866 due to its
lack of significance, this proposed rule
is not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This proposed rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations as required by
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or
any other Agency action under
Executive Order 13045, entitled
Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Pursuant to
the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency
previously assessed whether
establishment of tolerances, exemptions
from tolerances, raising of tolerance
levels, expansion of exemptions, or
revocations might significantly impact a
substantial number of small entities and
concluded that, as a general matter,
these actions do not impose a significant
economic impact on a substantial
number of small entities. These analyses
for tolerance establishments and
modifications, and for tolerance
revocations were published on May 4,
1981 (46 FR 24950) and on December
17, 1997 (62 FR 66020) (FRL–5753–1),
respectively, and were provided to the
Chief Counsel for Advocacy of the Small
Business Administration. Taking into
account this analysis, and available
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information concerning the pesticides
listed in this proposed rule, the Agency
hereby certifies that this proposed rule
will not have a significant negative
economic impact on a substantial
number of small entities. In a
memorandum dated May 25, 2001, EPA
determined that eight conditions must
all be satisfied in order for an import
tolerance or tolerance exemption
revocation to adversely affect a
significant number of small entity
importers, and that there is a negligible
joint probability of all eight conditions
holding simultaneously with respect to
any particular revocation. (This Agency
document is available in the docket of
this proposed rule). Furthermore, for the
pesticides named in this proposed rule,
the Agency knows of no extraordinary
circumstances that exist as to the
present proposal that would change the
EPA’s previous analysis. Any comments
about the Agency’s determination
should be submitted to the EPA along
with comments on the proposal, and
will be addressed prior to issuing a final
rule. In addition, the Agency has
determined that this action will not
have a substantial direct effect on States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This proposed
rule directly regulates growers, food
processors, food handlers, and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this
proposed rule does not have any ‘‘tribal
implications’’ as described in Executive
Order 13175, entitled Consultation and
Coordination with Indian Tribal
Governments (65 FR 67249, November
9, 2000). Executive Order 13175,
requires EPA to develop an accountable
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17:24 Dec 30, 2008
Jkt 217001
process to ensure ‘‘meaningful and
timely input by tribal officials in the
development of regulatory policies that
have tribal implications.’’ ‘‘Policies that
have tribal implications’’ is defined in
the Executive order to include
regulations that have ‘‘substantial direct
effects on one or more Indian tribes, on
the relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
proposed rule will not have substantial
direct effects on tribal governments, on
the relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this proposed rule.
referred to as ethylene chlorohydrin,
when ethylene oxide is used as a
postharvest fumigant in or on food
commodities as follows:
Parts per
million
Commodity
Herb and spice, group 19,
dried, except basil .................
Vegetable, dried .......................
940
940
*
*
*
*
*
4. Section 180.154 is amended by
revising the section heading and the
table in paragraph (a) to read as follows:
§180.154 Azinphos-methyl; tolerances for
residues.
(a) * * *
Commodity
Dated: December 22, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
Almond ......................
Almond, hulls ............
Apple .........................
Blueberry ..................
Cherry .......................
Crabapple .................
Parsley, leaves .........
Parsley, turnip rooted, roots ................
Pear ..........................
Pistachio ...................
Walnut .......................
Parts per
million
Expiration/Revocation
Date
0.2
5.0
1.5
5.0
2.0
1.5
5.0
10/30/09
10/30/09
9/30/12
9/30/12
9/30/12
9/30/12
9/30/12
2.0
1.5
0.3
0.3
9/30/12
9/30/12
10/30/09
10/30/09
*
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
PART 180—[AMENDED]
*
*
*
*
5. Section 180.155 is revised to read
as follows:
1. The authority citation for part 180
continues to read as follows:
§ 180.155 1-Naphthaleneacetic acid;
tolerances for residues.
Authority: 21 U.S.C. 321(q), 346a and 371.
§ 180.3
[Amended]
2. Section 180.3 is amended by
removing paragraph (d)(7) and
redesignating paragraphs (d)(8) through
(d)(13) as paragraphs (d)(7) through
(d)(12), respectively.
3. Section 180.151 is amended by
revising the table in paragraph (a)(1) and
by revising paragraph (a)(2) to read as
follows:
§ 180.151
residues.
Commodity
Ethylene oxide; tolerances for
(a) * * *
(1) * * *
Parts per
million
Commodity
Herb and spice, group 19,
dried, except basil .................
Vegetable, dried .......................
Walnut .......................................
7
7
50
(2) Tolerances are established for
residues of the ethylene oxide reaction
product, 2-chloroethanol, commonly
PO 00000
(a) General. Tolerances are
established for the combined residues of
the plant growth regulator 1naphthaleneacetic acid and its
conjugates calculated as 1naphthaleneacetic acid from the
application of 1-naphthaleneacetic acid,
its ammonium, sodium, or potassium
salts, ethyl ester, and acetamide in or on
food commodities as follows:
Frm 00017
Fmt 4702
Sfmt 4702
Cherry, sweet ...........................
Fruit, pome, group 11 ...............
Olive ..........................................
Orange ......................................
Pineapple 1 ...............................
Tangerine ..................................
Parts per
million
0.1
0.1
0.7
0.1
0.05
0.1
1 There are no U.S. registrations since
1988.
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
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6. Section 180.183 is amended by
revising paragraph (a) and paragraph (c)
to read as follows:
Commodity
§ 180.183 O,O-Diethyl S-[2-(ethylthio)ethyl]
phosphorodithioate; tolerances for
residues.
Wheat, hay ...............
Wheat, straw .............
(a) General. Tolerances are
established for the combined residues of
the insecticide disulfoton, O,O-diethyl
S-[2-(ethylthio)ethyl]
phosphorodithioate; demeton-S, O,Odiethyl S-[2-(ethylthio)ethyl]
phosphorothioate; disulfoton sulfoxide,
O,O-diethyl S-[2-(ethylsulfinyl)ethyl]
phosphorodithioate; disulfoton oxygen
analog sulfoxide, O,O-diethyl S-[2(ethylsulfinyl)ethyl] phosphorothioate;
disulfoton sulfone, O,O-diethyl S-[2(ethylsulfonyl)ethyl]
phosphorodithioate; and disulfoton
oxygen analog sulfone, O,O-diethyl S-[2(ethylsulfonyl)ethyl] phosphorothioate;
calculated as disulfoton, in or on food
commodities as follows:
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Commodity
Barley, grain .............
Barley, straw .............
Bean, lima .................
Bean, snap, succulent .....................
Broccoli .....................
Brussels sprouts .......
Cabbage ...................
Cattle, fat ..................
Cattle, meat ..............
Cattle, meat byproducts ........................
Cauliflower ................
Coffee, bean .............
Cotton, undelinted
seed ......................
Goat, fat ....................
Goat, meat ................
Goat, meat byproducts ........................
Grain, aspirated fractions .......................
Hog, fat .....................
Hog, meat .................
Hog, meat byproducts ........................
Horse, fat ..................
Horse, meat ..............
Horse, meat byproducts ........................
Lettuce, head ............
Lettuce, leaf ..............
Milk ...........................
Peanut ......................
Pepper ......................
Potato .......................
Sheep, fat .................
Sheep, meat .............
Sheep, meat byproducts ........................
Spinach .....................
Tomato ......................
Wheat, grain .............
VerDate Aug<31>2005
Parts per
million
Expiration/Revocation
Date
0.2
5.0
0.75
1/30/10
1/30/10
None
0.75
0.75
0.75
0.75
0.05
0.05
None
None
None
None
1/30/10
1/30/10
0.05
0.75
0.2
1/30/10
None
None
0.75
0.05
0.05
None
1/30/10
1/30/10
0.05
1/30/10
1/30/10
1/30/10
0.05
0.05
0.05
1/30/10
1/30/10
1/30/10
0.05
0.75
2
0.01
0.1
0.1
0.5
0.05
0.05
1/30/10
None
None
1/30/10
1/30/10
1/30/10
1/30/10
1/30/10
1/30/10
0.05
0.75
0.75
0.2
1/30/10
10/14/09
10/14/09
1/30/10
Expiration/Revocation
Date
5.0
5.0
1/30/10
1/30/10
*
*
*
*
*
(c) Tolerances with regional
registrations. Tolerances with regional
registration are established for the
combined residues of the insecticide
disulfoton, O,O-diethyl S-[2(ethylthio)ethyl] phosphorodithioate;
demeton-S, O,O-diethyl S-[2(ethylthio)ethyl] phosphorothioate;
disulfoton sulfoxide, O,O-diethyl S-[2(ethylsulfinyl)ethyl]
phosphorodithioate; disulfoton oxygen
analog sulfoxide, O,O-diethyl S-[2(ethylsulfinyl)ethyl] phosphorothioate;
disulfoton sulfone, O,O-diethyl S-[2(ethylsulfonyl)ethyl]
phosphorodithioate; and disulfoton
oxygen analog sulfone, O,O-diethyl S-[2(ethylsulfonyl)ethyl] phosphorothioate;
calculated as disulfoton, in or on food
commodities as follows:
1/30/10
0.3
0.05
0.05
Parts per
million
17:24 Dec 30, 2008
Jkt 217001
Parts per
million
Commodity
Asparagus .................................
0.1
*
*
*
*
*
7. Section 180.242 is amended by
revising the table in paragraph (a)(1) to
read as follows:
§180.242 Thiabendazole; tolerances for
residues.
(a) * * *
(1) * * *
Commodity
Apple, wet pomace ...
Avocado 1 .................
Banana, postharvest
Bean, dry, seed ........
Beet, sugar, dried
pulp .......................
Beet, sugar, roots .....
Beet, sugar, tops ......
Cantaloupe 1 .............
Carrot, roots,
postharvest ............
Citrus, oil ...................
Fruit, citrus, group
10, postharvest .....
Fruit, pome, group
11, postharvest .....
Mango .......................
Mushroom .................
Papaya, postharvest
Potato, postharvest ...
Soybean ....................
Strawberry 1 ..............
PO 00000
Frm 00018
Fmt 4702
Parts per
million
Expiration/Revocation
Date
12.0
10.0
3.0
0.1
None
None
None
None
3.5
0.25
10.0
15.0
12/25/10
12/25/10
12/25/10
None
10.0
15.0
None
None
10.0
None
5.0
10.0
40.0
5.0
10.0
0.1
5.0
None
None
None
None
None
None
None
Sfmt 4702
Commodity
Sweet potato
(postharvest to
sweet potato intended only for use
as seed) ................
Wheat, grain .............
Wheat, straw .............
Parts per
million
Expiration/Revocation
Date
0.05
1.0
1.0
None
None
None
1 There are no U.S. registrations on the indicated commodity.
*
*
*
*
*
8. Section 180.261 is amended by
revising the table in paragraph (a) to
read as follows:
§180.261 N-Mercaptomethyl phthalimide
S-(O,O-dimethyl phosphorodithioate) and
its oxygen analog; tolerances for residues.
(a) * * *
Commodity
Alfalfa, forage ...........................
Alfalfa, hay ................................
Almond, hulls ............................
Apple .........................................
Apricot .......................................
Blueberry ..................................
Cattle, fat ..................................
Cattle, meat ..............................
Cattle, meat byproducts ...........
Cherry .......................................
Cotton, refined oil .....................
Cotton, undelinted seed ...........
Cranberry ..................................
Fruit, citrus, group 10 ...............
Goat, fat ....................................
Goat, meat ................................
Goat, meat byproducts .............
Grape ........................................
Hog, fat .....................................
Hog, meat .................................
Hog, meat byproducts ..............
Horse, fat ..................................
Horse, meat ..............................
Horse, meat byproducts ...........
Kiwifruit .....................................
Milk ...........................................
Nectarine ..................................
Nut, tree, group 14 ...................
Pea, dry, seed ..........................
Pea, field, hay ...........................
Pea, field, vines ........................
Pea, succulent ..........................
Peach ........................................
Pear ..........................................
Plum, prune, fresh ....................
Potato .......................................
Sheep, fat .................................
Sheep, meat .............................
Sheep, meat byproducts ..........
Sweet potato, roots ..................
*
Parts per
million
20
40
10
10
5
10
0.2
0.1
0.1
10
0.2
0.1
10
5
0.1
0.1
0.1
10
0.2
0.04
0.04
0.1
0.1
0.1
25
0.1
5
0.1
0.5
20
10
1
10
10
5
0.1
0.1
0.1
0.1
12
*
*
*
*
9. Section 180.263 is revised to read
as follows:
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§180.263 Phosalone; tolerances for
residues.
Commodity
(a) General. Tolerances are
established for residues of the
insecticide phosalone, S-(6-chloro-3(mercaptomethyl)-2-benzoxazolinone)
O,O-diethyl phosphorodithioate, in or
on the following food commodities:
Commodity
Parts per
million
Expiration/
Revocation
Date
10.0
15.0
10.0
15.0
10.0
15.0
9/30/13
9/30/13
9/30/13
9/30/13
9/30/13
9/30/13
Apple 1 ....................
Cherry 1 ..................
Grape 1 ...................
Peach 1 ...................
Pear 1 .....................
Plum, prune, fresh 1
1
There are no U.S. registrations since
1992.
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
§ 180.309
[Removed]
10. Section 180.309 is removed.
11. Section 180.379 is revised to read
as follows:
§180.379 Fenvalerate; tolerances for
residues.
(a) General. Tolerances are
established for residues of the
insecticide fenvalerate, cyano(3phenoxyphenyl)methyl-4-chloro-a-(1methylethyl)benzeneacetate, in or on
food commodities as follows:
pwalker on PROD1PC71 with PROPOSALS
Commodity
Almond ......................
Almond, hulls ............
Apple .........................
Artichoke, globe ........
Bean, dry, seed ........
Bean, snap, succulent .....................
Broccoli .....................
Blueberry ..................
Cabbage ...................
Caneberry subgroup
13A ........................
Cantaloupe ...............
Carrot, roots ..............
Cattle, fat ..................
Cattle, meat ..............
Cattle, meat byproducts ........................
Cauliflower ................
Collards .....................
Corn, field, forage .....
Corn, field, grain .......
Corn, field, stover .....
Corn, pop, grain ........
Corn, pop, stover ......
Corn, sweet, forage ..
VerDate Aug<31>2005
Parts per
million
Expiration/Revocation
Date
0.2
15.0
2.0
0.2
0.25
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
2.0
2.0
3.0
10.0
4/2/10
4/2/10
4/2/10
4/2/10
3.0
1.0
0.5
1.5
1.5
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
1.5
0.5
10.0
50.0
0.02
50.0
0.02
50.0
50.0
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
17:24 Dec 30, 2008
Jkt 217001
Corn, sweet, kernel
plus cob with husks
removed ................
Corn, sweet, stover ..
Cotton, undelinted
seed ......................
Cucumber .................
Currant ......................
Eggplant ....................
Elderberry .................
Fruit, stone, group 12
Goat, fat ....................
Goat, meat ................
Goat, meat byproducts ........................
Gooseberry ...............
Hazelnut ....................
Hog, fat .....................
Hog, meat .................
Hog, meat byproducts ........................
Horse, fat ..................
Horse, meat ..............
Horse, meat byproducts ........................
Huckleberry ...............
Melon, honeydew .....
Milk ...........................
Milk, fat .....................
Muskmelon ...............
Pea ...........................
Pea, dry, seed ..........
Peanut ......................
Pear ..........................
Pecan ........................
Pepper ......................
Potato .......................
Pumpkin ....................
Radish, roots ............
Radish, tops ..............
Sheep, fat .................
Sheep, meat .............
Sheep, meat byproducts ........................
Soybean, seed ..........
Squash, summer ......
Squash, winter ..........
Sugarcane, cane ......
Sunflower, seed ........
Tomato ......................
Turnip, roots .............
Turnip, tops ...............
Walnut .......................
Watermelon ..............
Parts per
million
Expiration/Revocation
Date
0.1
50.0
4/2/10
4/2/10
0.2
0.5
3.0
1.0
3.0
10.0
1.5
1.5
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
1.5
3.0
0.2
1.5
1.5
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
1.5
1.5
1.5
4/2/10
4/2/10
4/2/10
1.5
3.0
1.0
0.3
7.0
1.0
1.0
0.25
0.02
2.0
0.2
1.0
0.02
1.0
0.3
8.0
1.5
1.5
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
1.5
0.05
0.5
1.0
2.0
1.0
1.0
0.5
20.0
0.2
1.0
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
4/2/10
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
§ 180.452
[Amended]
12. Section 180.452 is amended by
removing from the table in paragraph (a)
the entry ‘‘corn, sweet, kernel plus cob
with husks removed.’’
13. Section 180.533 is amended by
revising paragraph (a) and adding
paragraph (c) to read as follows:
PO 00000
Frm 00019
Fmt 4702
Sfmt 4702
80331
§180.533 Esfenvalerate; tolerances for
residues.
(a) General. (1) Tolerances are
established for the combined residues of
the insecticide esfenvalerate, (S)cyano(3-phenoxyphenyl)methyl-(S)-4chloro-a-(1-methylethyl)benzeneacetate,
its non-racemic isomer, (R)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and its
diastereomers (S)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and (R)cyano(3-phenoxyphenyl)methyl-(S)-4chloro-a-(1-methylethyl)benzeneacetate,
in or on food commodities as follows:
Commodity
Almond ......................................
Almond, hulls ............................
Apple .........................................
Artichoke, globe ........................
Bean, dry, seed ........................
Bean, snap, succulent ..............
Beet, sugar, roots .....................
Beet, sugar, tops ......................
Blueberry ..................................
Broccoli .....................................
Cabbage, except chinese cabbage ......................................
Caneberry subgroup 13A .........
Cantaloupe ...............................
Carrot, roots ..............................
Cattle, fat ..................................
Cattle, meat ..............................
Cattle, meat byproducts ...........
Cauliflower ................................
Collards .....................................
Corn, field, forage .....................
Corn, field, grain .......................
Corn, field, stover .....................
Corn, pop, grain ........................
Corn, pop, stover ......................
Corn, sweet, forage ..................
Corn, sweet, kernel plus cob
with husks removed ..............
Corn, sweet, stover ..................
Cotton, undelinted seed ...........
Cucumber .................................
Egg ...........................................
Eggplant ....................................
Elderberry .................................
Fruit, stone, group 12 ...............
Goat, fat ....................................
Goat, meat ................................
Goat, meat byproducts .............
Gooseberry ...............................
Hazelnut ....................................
Hog, fat .....................................
Hog, meat .................................
Hog, meat byproducts ..............
Horse, fat ..................................
Horse, meat ..............................
Horse, meat byproducts ...........
Kiwifruit .....................................
Lentil, seed ...............................
Melon, honeydew .....................
Milk ...........................................
Milk, fat .....................................
Muskmelon ...............................
Mustard greens .........................
Pea, dry, seed ..........................
Pea, succulent ..........................
E:\FR\FM\31DEP1.SGM
31DEP1
Parts per
million
0.2
5.0
1.0
1.0
0.25
1.0
0.05
5.0
1.0
1.0
3.0
1.0
0.5
0.5
1.5
1.5
1.5
0.5
3.0
15.0
0.02
15.0
0.02
15.0
15.0
0.1
15.0
0.2
0.5
0.03
0.5
1.0
3.0
1.5
1.5
1.5
1.0
0.2
1.5
1.5
1.5
1.5
1.5
1.5
0.5
0.25
0.5
0.3
7.0
0.5
5.0
0.25
0.5
80332
Federal Register / Vol. 73, No. 251 / Wednesday, December 31, 2008 / Proposed Rules
Commodity
Parts per
million
pwalker on PROD1PC71 with PROPOSALS
Peanut ......................................
Pear ..........................................
Pecan ........................................
Pepper ......................................
Potato .......................................
Poultry, fat ................................
Poultry, liver ..............................
Poultry, meat ............................
Poultry, meat byproducts, except liver ................................
Pumpkin ....................................
Radish, roots ............................
Radish, tops ..............................
Sheep, fat .................................
Sheep, meat .............................
Sheep, meat byproducts ..........
Sorghum, forage .......................
Sorghum, grain, grain ...............
Sorghum, grain, stover .............
Soybean, seed ..........................
Squash, summer ......................
Squash, winter ..........................
Sugarcane, cane ......................
Sunflower, seed ........................
Sweet potato, roots ..................
Tomato ......................................
Turnip, roots .............................
Turnip, tops ...............................
Walnut .......................................
Watermelon ..............................
0.02
1.0
0.2
0.5
0.02
0.3
0.03
0.03
0.3
0.5
0.3
3.0
1.5
1.5
1.5
10.0
5.0
10.0
0.05
0.5
0.5
1.0
0.5
0.05
0.5
0.5
7.0
0.2
0.5
(2) A tolerance of 0.05 ppm on raw
agricultural food commodities (other
than those food commodities already
covered by a higher tolerance as a result
of use on growing crops) is established
for the combined residues of the
insecticide esfenvalerate, (S)-cyano(3phenoxyphenyl)methyl-(S)-4-chloro-a(1-methylethyl)benzeneacetate, its nonracemic isomer, (R)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and its
diastereomers (S)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and (R)cyano(3-phenoxyphenyl)methyl-(S)-4chloro-a-(1-methylethyl)benzeneacetate
as a result of the use of esfenvalerate in
food-handling establishments.
*
*
*
*
*
(c) Tolerances with regional
registrations. Tolerances with regional
registration are established for the
combined residues of the insecticide
esfenvalerate, (S)-cyano(3phenoxyphenyl)methyl-(S)-4-chloro-a(1-methylethyl)benzeneacetate, its nonracemic isomer, (R)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and its
diastereomers (S)-cyano(3phenoxyphenyl)methyl-(R)-4-chloro-a(1-methylethyl)benzeneacetate and (R)cyano(3-phenoxyphenyl)methyl-(S)-4chloro-a-(1-methylethyl)benzeneacetate,
in or on food commodities as follows:
VerDate Aug<31>2005
17:24 Dec 30, 2008
Jkt 217001
follow the instructions provided on the
Web site for submitting comments. In
completing the transmittal screen, filers
Cabbage, chinese, bok choy ....
1.0 should include their full name, U.S.
Kohlrabi .....................................
2.0 Postal Service mailing address, and the
Lettuce, head ............................
5.0
applicable docket or rulemaking
number.
*
*
*
*
*
• E-mail: ecfs@fcc.gov. To get filing
instructions, filers should send an e§ 180.626 [Amended]
mail to ecfs@fcc.gov, and include the
14. Section 180.626 is amended by
removing the entry for peanut, hay from following words in the body of the
message, ‘‘get form.’’ A sample form and
the table in paragraph (a)(1).
directions will be sent in response.
[FR Doc. E8–31182 Filed 12–30–08; 8:45 am]
• Mail: Filings can be sent by
BILLING CODE 6560–50–S
commercial overnight courier or by firstclass or overnight U.S. Postal Service
mail (although we continue to
FEDERAL COMMUNICATIONS
experience delays in receiving U.S.
COMMISSION
Postal Service mail). Parties who choose
to file by paper must file an original and
47 CFR Part 73
four copies of each filing. If more than
[MB Docket No. 08–255; FCC 08–281]
one docket or rulemaking number
appears in the caption of this
Implementation of Short-term Analog
proceeding, filers must submit two
Flash and Emergency Readiness Act;
additional copies for each additional
Establishment of DTV Transition
docket or rulemaking number. All
‘‘Analog Nightlight’’ Program
filings must be addressed to the
Commission’s Secretary, Office of the
AGENCY: Federal Communications
Secretary, Federal Communications
Commission.
Commission. Commercial overnight
ACTION: Proposed rule.
mail (other than U.S. Postal Service
SUMMARY: This document describes and
Express Mail and Priority Mail) must be
seeks comment on the Commission’s
sent to 9300 East Hampton Drive,
implementation of the Short-term
Capitol Heights, MD 20743. U.S. Postal
Analog Flash and Emergency Readiness Service first-class, Express, and Priority
Act (‘‘Analog Nightlight Act’’), S. 3663,
mail should be addressed to 445 12th
110th Cong., as enacted December 23,
Street, SW., Washington, DC 20554.
2008. The Analog Nightlight Act
• Hand Delivery/Courier: Filings can
requires the Commission to develop and be sent by hand or messenger delivery.
implement a program by January 15,
The Commission’s contractor will
2009, to ‘‘encourage and permit’’
receive hand-delivered or messengercontinued analog TV service for a
delivered paper filings for the
period of thirty days after the February
Commission’s Secretary at 236
17, 2009 DTV transition date, where
Massachusetts Avenue, NE., Suite 110,
technically feasible, to provide ‘‘public
Washington, DC 20002. The filing hours
safety information’’ and ‘‘DTV transition at this location are 8 a.m. to 7 p.m. All
information.’’ For consumers who are
hand deliveries must be held together
not capable of receiving digital
with rubber bands or fasteners. Any
television signals by the transition
envelopes must be disposed of before
deadline, the Analog Nightlight program entering the building. Parties who
proposed herein will ensure that there
choose to file by paper must file an
is no interruption in the provision of
original and four copies of each filing.
critical emergency information and will All filings must be addressed to the
provide useful information regarding
Commission’s Secretary, Office of the
the transition to help consumers
Secretary, Federal Communications
establish digital service.
Commission.
DATES: Comments are due on or before
• Accessibility Information: Contact
January 5, 2009; reply comments are
the FCC to request information in
due on or before January 8, 2009.
accessible formats (computer diskettes,
large print, audio recording, and Braille)
ADDRESSES: You may submit comments,
identified by MB Docket No. 08–255, by by sending an e-mail to fcc504@fcc.gov
or calling the FCC’s Consumer and
any of the following methods:
• Federal eRulemaking Portal: https:// Governmental Affairs Bureau at (202)
418–0530 (voice), (202) 418–0432
www.regulations.gov. Follow the
(TTY). This document can also be
instructions for submitting comments.
• Federal Communications
downloaded in Word and Portable
Commission’s Web Site: https://
Document Format (PDF) at: https://
www.fcc.gov/cgb/ecfs/. Filers should
www.fcc.gov.
PO 00000
Parts per
million
Commodity
Frm 00020
Fmt 4702
Sfmt 4702
E:\FR\FM\31DEP1.SGM
31DEP1
Agencies
[Federal Register Volume 73, Number 251 (Wednesday, December 31, 2008)]
[Proposed Rules]
[Pages 80317-80332]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-31182]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0834; FRL-8394-7]
Azinphos-methyl, Disulfoton, Esfenvalerate, Ethylene oxide,
Fenvalerate, et al.; Proposed Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to revoke certain tolerances for the
fungicides prothioconazole and thiabendazole; the herbicide
primisulfuron- methyl; and the insecticides azinphos-methyl,
disulfoton, esfenvalerate, fenvalerate, and phosalone; the plant growth
regulator 1-naphthaleneacetic acid; and the antimicrobial/insecticidal
agent ethylene oxide. Also, EPA is proposing to modify certain
tolerances for the insecticides disulfoton, esfenvalerate, and phosmet;
and the plant growth regulator 1-naphthaleneacetic acid. In addition,
EPA is proposing to establish new tolerances for the insecticides
disulfoton, esfenvalerate, and phosmet; and the antimicrobial/
insecticidal agent ethylene oxide and ethylene chlorohydrin (a reaction
product formed during the fumigation/sterilization process). The
regulatory actions proposed in this document are in follow-up to the
Agency's reregistration program under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), and tolerance reassessment
program under the Federal Food, Drug, and Cosmetic Act (FFDCA), section
408(q).
DATES: Comments must be received on or before March 2, 2009.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0834, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0834. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http:/
/www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or e-mail. The
regulations.gov website is an ``anonymous access'' system, which
[[Page 80318]]
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. 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 in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave, NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8037; e-mail
address: nevola.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II.A. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
C. What Can I do if I Wish the Agency to Maintain a Tolerance that the
Agency Proposes to Revoke?
This proposed rule provides a comment period of 60 days for any
person to state an interest in retaining a tolerance proposed for
revocation. If EPA receives a comment within the 60-day period to that
effect, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
FFDCA section 408(f), if needed. The order would specify data needed
and the timeframes for its submission, and would require that within 90
days some person or persons notify EPA that they will submit the data.
If the data are not submitted as required in the order, EPA will take
appropriate action under FFDCA.
EPA issues a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposal, you may also submit an objection
at the time of the final rule. If you fail to file an objection to the
final rule within the time period specified, you will have waived the
right to raise any issues resolved in the final rule. After the
specified time, issues resolved in the final rule cannot be raised
again in any subsequent proceedings.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to revoke, modify, and establish specific
tolerances for residues of the fungicides prothioconazole and
thiabendazole; the herbicide primisulfuron-methyl; and the insecticides
azinphos-methyl, disulfoton, esfenvalerate, fenvalerate, phosalone, and
phosmet; the plant growth regulator 1-naphthaleneacetic acid; and the
antimicrobial/insecticidal agent ethylene oxide and its reaction
product ethylene chlorohydrin in or on commodities listed in the
regulatory text.
EPA is proposing these tolerance actions for disulfoton, ethylene
oxide, 1-naphthaleneacetic acid, and phosmet to implement the tolerance
recommendations made during the reregistration and tolerance
reassessment processes (including
[[Page 80319]]
follow-up on canceled or additional uses of pesticides). However, in
the case of prothioconazole, the proposed tolerance revocation herein
is not associated with the reregistration or tolerance reassessment
processes, but rather with an existing label prohibition. In the cases
of azinphos-methyl, fenvalerate, primisulfuron-methyl, and
thiabendazole, the proposed tolerance revocations herein are associated
with no active U.S. registrations for specific food uses, and in the
case of phosalone, the proposed revocations are associated with a
follow-up to the withdrawal of a comment to maintain tolerances for
import purposes, as described in Unit II.A. In the case of
esfenvalerate, an isomer of fenvalerate, proposed tolerances to be
established (for those food commodities with U.S. registrations for
esfenvalerate) are being converted from fenvalerate tolerances due to a
phase out of fenvalerate use in the United States, and the proposed
tolerance revocation on a processed commodity tolerance is associated
with data that shows such residues are covered by the appropriate
tolerance on the raw agricultural commodity for which the Agency is
proposing a decreased level herein. As part of these processes, EPA is
required to determine whether each of the amended tolerances meets the
safety standard of FFDCA. The safety finding determination of
``reasonable certainty of no harm'' is discussed in detail in each
Reregistration Eligibility Decision (RED) and Report of the Food
Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk
Management Decision (TRED) for the active ingredient. REDs and TREDs
recommend the implementation of certain tolerance actions, including
modifications to reflect current use patterns, meet safety findings,
and change commodity names and groupings in accordance with new EPA
policy. Printed copies of many REDs and TREDs may be obtained from
EPA's National Service Center for Environmental Publications (EPA/
NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419; telephone number: 1-
800-490-9198; fax number: 1-513-489-8695; Internet at https://
www.epa.gov/ncepihom and from the National Technical Information
Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161; telephone
number: 1-800-553-6847 or (703) 605-6000; Internet at https://
www.ntis.gov. Electronic copies of REDs and TREDs are available on the
Internet in public dockets for 1-naphthaleneacetic acid (EPA-HQ-OPP-
2006-0507) and TREDs for ethylene oxide (EPA-HQ-OPP-2005-0203) and
primisulfuron-methyl (EPA-HQ-OPP-2002-0163) at https://
www.regulations.gov and REDs for azinphos-methyl, disulfoton, phosmet,
and thiabendazole at https://www.epa.gov/pesticides/reregistration/
status.htm.
The selection of an individual tolerance level is based on crop
field residue studies designed to produce the maximum residues under
the existing or proposed product label. Generally, the level selected
for a tolerance is a value slightly above the maximum residue found in
such studies, provided that the tolerance is safe. The evaluation of
whether a tolerance is safe is a separate inquiry. EPA recommends the
raising of a tolerance when data show that:
Lawful use (sometimes through a label change) may result
in a higher residue level on the commodity.
The tolerance remains safe, notwithstanding increased
residue level allowed under the tolerance.
In REDs, Chapter IV on ``Risk Management, Reregistration, and Tolerance
Reassessment'' typically describes the regulatory position, FQPA
assessment, cumulative safety determination, determination of safety
for U.S. general population, and safety for infants and children. In
particular, the human health risk assessment document which supports
the RED describes risk exposure estimates and whether the Agency has
concerns. In TREDs, the Agency discusses its evaluation of the dietary
risk associated with the active ingredient and whether it can determine
that there is a reasonable certainty (with appropriate mitigation) that
no harm to any population subgroup will result from aggregate exposure.
EPA also seeks to harmonize tolerances with international standards set
by the Codex Alimentarius Commission, as described in Unit III.
Explanations for proposed modifications in tolerances and/or
establishments of tolerances for disulfoton, ethylene oxide, 1-
naphthaleneactic acid, and phosmet can be found in the RED and TRED
document and in more detail in the Residue Chemistry Chapter document
which supports the RED and TRED. Esfenvalerate was not subject to the
reregistration program because it was registered after November 1,
1984. However, the explanation for the proposed modification in one
tolerance and establishments of other tolerances for esvenvalerate can
be found in the Residue Chemistry Chapter available in the public
docket for this proposed rule. Copies of the Residue Chemistry Chapter
documents are found in the Administrative Record and paper copies for
ethylene oxide and 1-naphthaleneacetic acid can be found under their
respective public docket ID numbers, identified in Unit II.A. Paper
copies for disulfoton, esfenvalerate, and phosmet are available in the
public docket for this proposed rule. Electronic copies are available
through EPA's electronic public docket and comment system,
regulations.gov at https://www.regulations.gov. You may search for
docket ID number EPA-HQ-OPP-2008-0834, then click on that docket ID
number to view its contents.
EPA has determined that the aggregate exposures and risks are not
of concern for the above mentioned pesticide active ingredients based
upon the data identified in the RED or TRED which lists the submitted
studies that the Agency found acceptable.
EPA has found that the tolerances that are proposed in this
document to be modified, are safe; i.e., that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residues, in accordance
with FFDCA section 408(b)(2)(C). (Note that changes to tolerance
nomenclature do not constitute modifications of tolerances). These
findings are discussed in detail in each RED or TRED. The references
are available for inspection as described in this document under
SUPPLEMENTARY INFORMATION.
In addition, EPA is proposing to revoke certain specific tolerances
because either they are no longer needed or are associated with food
uses that are no longer registered under FIFRA. Those instances where
registrations were canceled were because the registrant failed to pay
the required maintenance fee and/or the registrant voluntarily
requested cancellation of one or more registered uses of the pesticide.
It is EPA's general practice to propose revocation of those tolerances
for residues of pesticide active ingredients on crop uses for which
there are no active registrations under FIFRA, unless any person in
comments on the proposal indicates a need for the tolerance to cover
residues in or on imported commodities or legally treated domestic
commodities.
1. Azinphos-methyl. On December 28, 2005 (70 FR 76827) (FRL-7752-
5), the Agency published a notice in the Federal Register and approved
requests from registrants to voluntarily amend their product
registrations to terminate certain azinphos-methyl uses effective
December 28, 2005. These amendments follow a September 30, 2002 Federal
Register Notice of Receipt of Requests
[[Page 80320]]
(67 FR 61337) (FRL-7199-6) from the azinphos-methyl registrants to
amend their product registrations to terminate certain uses. The
amendments terminated azinphos-methyl use on a number of commodities,
including alfalfa, bean (succulent and snap), broccoli, cabbage
(including chinese), cauliflower, celery, citrus, clover, cucumber,
eggplant, grape, hazelnut (filbert), melon, onion (green and dry bulb),
pecan, pepper, fresh plum, dried plum, quince, spinach, strawberry,
tomato, and birdsfoot trefoil. All sale and distribution of existing
stocks of end-use products bearing these uses by registrants was
prohibited 90-calendar days after receipt of EPA approved revised
labels reflecting the use deletions; i.e., after August 2003. The
Agency believes that end users will have had sufficient time to exhaust
existing stocks and for treated commodities to have cleared the
channels of trade. Therefore the associated tolerances are no longer
needed. Consequently, EPA is proposing to revoke the tolerances in 40
CFR 180.154 on alfalfa, forage; alfalfa, hay; bean, snap, succulent;
broccoli; cabbage; cauliflower; celery; clover, forage; clover, hay;
cucumber; eggplant; fruit, citrus, group 10; grape; hazelnut; melon;
onion; pecan; pepper; plum, prune; quince; spinach; strawberry; tomato,
postharvest; trefoil, forage; and trefoil, hay.
On July 5, 2006 (71 FR 38148) (FRL-8076-4) and March 29, 2006 (71
FR 15731) (FRL-7771-4), the Agency published notices in the Federal
Register and approved requests from registrants to voluntarily amend
their product registrations to terminate certain azinphos-methyl uses
on caneberry (blackberry, boysenberry, loganberry, raspberry), cotton,
cranberry, nectarine (covered by the peach tolerance under 40 CFR
180.1(g)), peach, and potato effective September 30, 2006. The Agency
believes that end users will have had sufficient time for treated
commodities to have cleared the channels of trade. Therefore the
associated tolerances are no longer needed. Consequently, EPA is
proposing to revoke the tolerances in 40 CFR 180.154 on blackberry;
boysenberry; cotton, undelinted seed; cranberry; loganberry; peach;
potato; and raspberry.
On March 26, 2008 (73 FR 16006) (FRL-8355-1) and February 20, 2008
(73 FR 9328) (FRL-8349-8), the Agency published notices in the Federal
Register and approved requests from registrants to voluntarily cancel
and amend their product registrations to terminate azinphos-methyl uses
on Brussels sprouts effective September 30, 2008, on almonds,
pistachios, and walnuts effective October 30, 2009, and on apples,
blueberries, cherries, parsley, and pears effective September 30, 2012.
Treated commodities subject to the final rule and that are in the
channels of trade following the tolerance revocations are subject to
FFDCA section 408(l)(5). Residues of pesticides whose tolerances have
been revoked do not render the food adulterated so long as it is shown
to the satisfaction of the Food and Drug Administration that residue is
present as the result of an application or use of the pesticide at a
time and in a manner that was lawful under FIFRA and the residue does
not exceed the level that was authorized at the time of the application
or use to be present on the food under a tolerance or exemption from
tolerance. Evidence to show that food was lawfully treated may include
records that verify the dates that the pesticide was applied to such
food. Therefore, the associated tolerances will no longer be needed
after the last use dates specified. Consequently, EPA is proposing to
revoke the tolerances in 40 CFR 180.154 on Brussels sprouts on the date
of publication of the final rule in the Federal Register, on almond;
almond, hulls; pistachio; and walnut; each with an expiration/
revocation date of October 30, 2009, and on apple; crabapple;
blueberry; cherry; parsley, leaves; parsley, turnip rooted, roots; and
pear; each with an expiration/revocation date of September 30, 2012.
In addition, because the tolerance expired on June 30, 2000, EPA is
proposing to remove the tolerance in 40 CFR 180.154 on sugarcane, cane.
Also, EPA is proposing to revise the section heading in 40 CFR
180.154 from O,O-Dimethyl S-[(4-oxo-1,2,3-benzotriazin-3(4H)-
yl)methyl]phosphorodithioate to that of azinphos-methyl.
There are Codex Maximum Residue Limits (MRLs) for residues of
azinphos-methyl on alfalfa forage; almonds; almond hulls; apple;
blueberries; broccoli; cherries; clover hay or fodder; cottonseed;
cranberry; cucumber; fruits (except as otherwise listed); melons,
except watermelon; peach; pear; pecan; peppers, chili (dry); peppers,
sweet; plums (including prunes); potato; tomato; vegetables (except as
otherwise listed); and walnuts.
2. Disulfoton, O,O-Diethyl S-[2-
(ethylthio)ethyl]phosphorodithioate. Currently, tolerances for
disulfoton in 40 CFR 180.183(a) and (c) are established for the
combined residues of disulfoton, O,O-diethyl S-[2-(ethylthio)ethyl]
phosphorodithioate, and its cholinesterase-inhibiting metabolites,
calculated as demeton. Based on plant and animal metabolism data, the
Agency determined that residues of concern should include the sulfoxide
and sulfone degradates and oxygen analogues of the sulfoxide and
sulfone degradates and calculated as disulfoton in compatibility with
the Codex expression. Therefore, EPA is proposing to revise the
introductory text containing the tolerance expression in 40 CFR
180.183(a) to read as follows: ``Tolerances are established for the
combined residues of the insecticide disulfoton, O,O-diethyl S-[2-
(ethylthio)ethyl] phosphorodithioate; demeton-S, O,O-diethyl S-[2-
(ethylthio)ethyl] phosphorothioate; disulfoton sulfoxide, O,O-diethyl
S-[2-(ethylsulfinyl)ethyl] phosphorodithioate; disulfoton oxygen analog
sulfoxide, O,O-diethyl S-[2-(ethylsulfinyl)ethyl] phosphorothioate;
disulfoton sulfone, O,O-diethyl S-[2-(ethylsulfonyl)ethyl]
phosphorodithioate; and disulfoton oxygen analog sulfone, O,O-diethyl
S-[2-(ethylsulfonyl)ethyl] phosphorothioate; calculated as disulfoton,
in or on food commodities as follows.''
Also, EPA is proposing to revise the introductory text containing
the tolerance expression in 40 CFR 180.183(c) to read as follows:
``Tolerances with regional registration are established for the
combined residues of the insecticide disulfoton, O,O-diethyl S-[2-
(ethylthio)ethyl] phosphorodithioate; demeton-S, O,O-diethyl S-[2-
(ethylthio)ethyl] phosphorothioate; disulfoton sulfoxide, O,O-diethyl
S-[2-(ethylsulfinyl)ethyl] phosphorodithioate; disulfoton oxygen analog
sulfoxide, O,O-diethyl S-[2-(ethylsulfinyl)ethyl] phosphorothioate;
disulfoton sulfone, O,O-diethyl S-[2-(ethylsulfonyl)ethyl]
phosphorodithioate; and disulfoton oxygen analog sulfone, O,O-diethyl
S-[2-(ethylsulfonyl)ethyl] phosphorothioate; calculated as disulfoton,
in or on food commodities as follows.''
In the Federal Register of May 21, 2008 (73 FR 29507) (FRL-8364-7),
EPA issued a notice regarding EPA's announcement of the receipt of
requests from a registrant to voluntarily amend certain registrations
for disulfoton, including deletion of the last barley and wheat uses
from disulfoton registrations. EPA approved the barley and wheat use
deletions for disulfoton and issued a cancellation order on July 30,
2008 (73 FR 44263) (FRL-8375-7) and permitted the registrants to sell
and distribute product under the previously approved labeling for a
period of 6 months after the effective date of the cancellation order;
i.e., until January 30,
[[Page 80321]]
2009. The Agency believes that end users will have had sufficient time
to exhaust existing stocks and for disulfoton-treated barley and wheat
commodities to have cleared the channels of trade by January 30, 2010.
Therefore, EPA is proposing to revoke the tolerances in 40 CFR
180.183(a) on barley, grain; barley, straw; wheat, hay; wheat, grain;
and wheat, straw; each with an expiration/revocation date of January
30, 2010. In addition, based on field trial data and in order to be
compatible with Codex MRLs of 0.2 milligram/kilogram (mg/kg), EPA
determined that the tolerance on wheat, grain should be decreased from
0.3 to 0.2 parts per million (ppm). Also, the Agency determined that
wheat data may be translated to barley and the tolerance on barley,
grain should be decreased from 0.75 to 0.2 ppm. Therefore, EPA is
proposing to decrease the tolerances in 40 CFR 180.183 on barley, grain
and wheat, grain; each to 0.2 ppm, the appropriate tolerance level for
the interim period before each tolerance expires on January 30, 2010.
Available wheat processing data showed that disulfoton residues of
concern concentrated in wheat aspirated grain fractions at 1.35X and
based on a reassessed tolerance for wheat, grain at 0.2 ppm (see the
disulfoton RED), and the translation of wheat data to barley, EPA
determined that a tolerance should be established on aspirated grain
fractions at 0.3 ppm. Therefore, EPA is proposing to establish a
tolerance in 40 CFR 180.183(a) on grain, aspirated fractions at 0.3 ppm
with an expiration/revocation date of January 30, 2010.
Based on available field trial data that showed combined disulfoton
residues of concern as high as <0.2 ppm on coffee beans, EPA determined
that the tolerance should be decreased from 0.3 to 0.2 ppm. Therefore,
EPA is proposing to decrease the tolerance in 40 CFR 180.183(a) on
coffee, bean to 0.2 ppm.
In the Federal Register of September 12, 2008 (73 FR 53007) (FRL-
8380-7), EPA issued a notice regarding EPA's announcement of the
receipt of requests from a registrant to voluntarily cancel certain
registrations for disulfoton, including termination of the last spinach
and tomato uses from disulfoton registrations. On October 14, 2008, EPA
approved the registration cancellations for disulfoton and issued a
cancellation order to the registrant and permitted the registrant to
sell and distribute product under the previously approved labeling
until April 11, 2009. Typically, the Agency will permit a registrant to
sell and distribute existing stocks for 1 year after the date the
cancellation request was received. Such policy is in accordance with
the Agency's statement of policy as set forth in the Federal Register
of June 26, 1991 (56 FR 29362) (FRL-3846-4). However, in this case, the
registrant, Bonide Products, Inc. (Bonide), has provided information to
the Agency that these registrations were dormant, the pesticide has not
been recently produced or distributed by Bonide, and that no existing
stocks provision is needed by Bonide in association with these
cancellation requests. However, in its request of April 11, 2008 for
voluntary cancellation, Bonide noted that previously sold/distributed
product may be in the channels of trade. The Agency believes that end
users will have had sufficient time (18 months) to exhaust existing
stocks and for disulfoton-treated spinach and tomato commodities to
have cleared the channels of trade by October 14, 2009. Therefore, EPA
is proposing to revoke the tolerances in 40 CFR 180.183(a) on spinach
and tomato; each with an expiration/revocation date of October 14,
2009.
Also, in Federal Register notices of September 12, 2008 (73 FR
53007) (FRL-8380-7) and May 21, 2008 (73 FR 29507) (FRL-8364-7), EPA
announced the receipt of requests from registrants to voluntarily
cancel certain or amend registrations for disulfoton, which include the
last potato use registrations. On October 14, 2008, the Agency issued a
cancellation order for specific Bonide registrations and permitted the
registrant to sell and distribute product under the previously approved
labeling until April 11, 2009. However, Bonide, the registrant, had
informed the Agency in its request of April 11, 2008, that while the
associated registrations were dormant ones where the pesticide has not
been recently produced or distributed by the registrant such that it
did not need an existing stocks provision, previously sold/distributed
product in the channels of trade would need an existing stocks
provision. The Agency believes that end users will have had sufficient
time to exhaust existing stocks and for disulfoton-treated potato
commodities to have cleared the channels of trade by October 14, 2009.
However, the Agency issued an order on July 30, 2008 (73 FR 44263)
(FRL-8375-7) to amend and terminate certain uses, including potato, for
specific Bayer CropSciences registrations and permitted the registrant
to sell and distribute product under the previously approved labeling
until January 30, 2009. The Agency believes that end users will have
had sufficient time to exhaust existing stocks and for disulfoton-
treated potato commodities to have cleared the channels of trade by
January 30, 2010. Consequently, using the latter date, EPA is proposing
to revoke the tolerance in 40 CFR 180.183(a) on potato with an
expiration/revocation date of January 30, 2010. In addition, based on
field trial data that showed disulfoton residues of concern at less
than 0.5 ppm, EPA determined that the tolerance on potatoes should be
decreased from 0.75 to 0.5 ppm. Therefore, EPA is proposing to decrease
the tolerance in 40 CFR 180.183 on potato to 0.5 ppm, the appropriate
tolerance level for the interim period before it expires on January 30,
2010.
In the Federal Register of December 15, 2004 (69 FR 75061) (FRL-
7689-8), EPA issued a notice which announced the receipt of requests
from a registrant to voluntarily amend a specific registration for
disulfoton, including deletion of the last peanut and pepper uses. EPA
approved the amendments, including the peanut and pepper use deletions
for disulfoton in an order issued on October 10, 2007 (72 FR 57571)
(FRL-8151-8), and permitted the registrant and others to sell,
distribute, and use product under the previously approved labeling
until stocks are exhausted. The registrant and others have had more
than 4 years since the voluntary amendment requests and more than 1
year since the amendment order to sell and distribute stocks and the
Agency believes that end users will have had sufficient time to exhaust
existing stocks and for disulfoton-treated peanut and pepper
commodities to have cleared the channels of trade by January 30, 2010.
Also, based on available data that showed combined disulfoton residues
of concern below 0.1 ppm in or on nutmeat, the Agency determined that
the tolerance should be decreased from 0.75 to 0.1 ppm. Therefore, EPA
is proposing to revoke the tolerances in 40 CFR 180.183(a) on peanut
and pepper; each with an expiration/revocation date of January 30,
2010, and decrease the tolerance on peanut to 0.1 ppm for the interim
period before it expires.
There have been no active registrations in the United States for
disulfoton use on peas since 2002. The Agency believes that end users
have had sufficient time to exhaust existing stocks and for disulfoton-
treated peas to have cleared the channels of trade. Therefore, EPA is
proposing to revoke the tolerances in 40 CFR 180.183(a) on pea, dry,
seed; pea, field, vines; and pea, succulent.
Based on available field trial data that showed combined disulfoton
residues of
[[Page 80322]]
concern as high as 1.15 ppm on leaf lettuce, EPA determined that the
existing tolerance for lettuce at 0.75 ppm should be revised and a
separate tolerance for leaf lettuce should be increased from 0.75 to 2
ppm. Therefore, EPA is proposing to revise the tolerance on lettuce at
0.75 ppm in 40 CFR 180.183(a) and separate it into lettuce, head at
0.75 and lettuce, leaf at 2 ppm. The Agency determined that the
increased tolerance is safe; i.e., there is a reasonable certainty that
no harm will result from aggregate exposure to the pesticide chemical
residue.
Based on available metabolism and cattle feeding data (3.6X) that
showed combined disulfoton residues of concern in milk were as high as
0.012 ppm, EPA calculated residues at the 1X feeding level to be <0.01
ppm. Therefore, EPA determined that a tolerance should be established
on milk at 0.01 ppm with an expiration/revocation date of January 30,
2010. Also, based on available metabolism and cattle feeding data
(0.7X) that showed combined disulfoton residues of concern in or on
meat and meat byproducts as high as <0.01 ppm in fat and muscle, and
0.03 ppm in kidney, EPA calculated that residues at the 1X feeding
level are expected to be <0.05 ppm in meat byproducts. Therefore, EPA
determined that tolerances on the fat, meat and meat byproducts of
cattle, goats, hogs, horses, and sheep should be established at 0.05
ppm. Currently, there are label restrictions against the grazing of
disulfoton-treated cotton fields and feeding of treated cotton forage
to livestock and cotton forage is not considered by EPA to be a
significant livestock feed item. While cotton gin byproducts may
occasionally serve as a livestock feed, the Agency has determined that
there is no reasonable expectation that disulfoton residues would
transfer to livestock tissue. However, based on the feed crops of
barley, peanut, and wheat that are proposed herein for tolerance
revocation, each with an expiration/revocation date of January 30,
2010, the Agency determined that the livestock and milk tolerances
should be established, each with an expiration/revocation date of
January 30, 2010. Consequently, EPA is proposing to establish
tolerances in 40 CFR 180.183(a) on cattle, fat; cattle, meat; cattle,
meat byproducts; goat, fat; goat, meat; goat, meat byproducts; hog,
fat; hog, meat; hog, meat byproducts; horse, fat; horse, meat; horse,
meat byproducts; sheep, fat; sheep, meat; and sheep, meat byproducts,
each at 0.05 ppm and with an expiration/revocation date of January 30,
2010, and on milk at 0.01 ppm with an expiration/revocation date of
January 30, 2010.
There are Codex MRLs for combined residues of disulfoton, demeton-
S, and their sulfoxides and sulfones on a number of commodities,
including barley, barley straw, peanut, wheat, and wheat straw.
3. Esfenvalerate. Existing tolerances for fenvalerate are proposed
herein to be converted to esfenvalerate tolerances for those crops with
U.S. registrations for esfenvalerate. This is because fenvalerate uses
are being phased out in the United States. Esfenvalerate and
fenvalerate are considered chemically and toxicologically equivalent by
EPA. Esfenvalerate is the S,S-isomer (the most insecticidally active
isomer) enriched version of fenvalerate. Currently, esfenvalerate
tolerances in 40 CFR 180.533(a) are established for residues of
esfenvalerate, (S)-cyano(3-phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-
(1-methylethyl)benzeneacetate. The Agency had determined that residues
of concern should include its non-racemic isomer, (R)-cyano(3-
phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-methylethyl)benzeneacetate
and its diastereomers (S)-cyano(3-phenoxyphenyl)methyl-(R)-4-chloro-
[alpha]-(1-methylethyl)benzeneacetate and (R)-cyano(3-
phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate. In addition, the Agency determined that
proposed and existing tolerances for residues of concern as a result of
esfenvalerate use on food commodities should be recodified into 40 CFR
180.533(a)(1) and separated from the proposed tolerance on food
commodities for residues of concern as a result of esfenvalerate use in
food-handling establishments. Therefore, EPA is proposing to revise the
introductory text containing the tolerance expression in 40 CFR
180.533(a) and recodify that section under 40 CFR 180.533(a)(1), as
follows: ``Tolerances are established for the combined residues of the
insecticide esfenvalerate, (S)-cyano(3-phenoxyphenyl)methyl-(S)-4-
chloro-[alpha]-(1-methylethyl)benzeneacetate, its non-racemic isomer,
(R)-cyano(3-phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate and its diastereomers (S)-cyano(3-
phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-methylethyl)benzeneacetate
and (R)-cyano(3-phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, in or on food commodities as follows:.''
In order to cover current registrations for use of esfenvalerate in
food-handling establishments, EPA is proposing to establish a tolerance
of 0.05 ppm under newly recodified 40 CFR 180.533(a)(2) on raw
agricultural food commodities (other than those food commodities
already covered by a higher tolerance as a result of use on growing
crops) for the combined residues of the insecticide esfenvalerate, (S)-
cyano(3-phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, its non-racemic isomer, (R)-cyano(3-
phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-methylethyl)benzeneacetate
and its diastereomers (S)-cyano(3-phenoxyphenyl)methyl-(R)-4-chloro-
[alpha]-(1-methylethyl)benzeneacetate and (R)-cyano(3-
phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate.
Based on available data that showed combined esfenvalerate residues
of concern that were non-detectable (<0.01 ppm) in or on sugar beet
roots, and in order to harmonize with the fenvalerate Codex MRL for
root and tuber vegetables, EPA determined that the tolerance should be
decreased from 0.5 to 0.05 ppm. Therefore, EPA is proposing to decrease
the tolerance in newly recodified 40 CFR 180.533(a)(1) on beet, sugar,
roots to 0.05 ppm. In addition, based on available processing data that
showed an average concentration factor of 4.5X for dried sugar beet
pulp and the highest average field trial (HAFT) for sugar beet roots
(<0.01 ppm), EPA determined that the expected combined esfenvalerate
residues of concern in dried sugar beet pulp are <0.045 ppm. Because
the proposed tolerance for the raw agricultural commodity (sugar beet
root) at 0.05 ppm should sufficiently cover expected combined
esfenvalerate residues of concern in or on sugar beet pulp resulting
from registered use, the Agency determined that the existing tolerance
on dried sugar beet pulp is no longer needed and should be revoked.
Therefore, the Agency is proposing to revoke the tolerance in newly
recodified 40 CFR 180.533(a)(1) on beet, sugar, dried pulp.
Because the existing tolerances for kohlrabi and head lettuce
support regional registrations in Texas and Arizona, California,
Colorado, Florida, New Mexico, and Texas, respectively, EPA determined
that these tolerances are no longer general tolerances and should be
redesignated as regional registrations. Therefore, the Agency is
proposing to recodify tolerances on kohlrabi at 2.0 ppm and lettuce,
head at 5.0 ppm from 40 CFR 180.533(a) into 40 CFR 180.533(c) for
regional tolerances. Also, because that section is currently reserved,
EPA is proposing introductory text as follows: ``Tolerances with
regional registration are established for the combined residues of the
insecticide
[[Page 80323]]
esfenvalerate, (S)-cyano(3-phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-
(1-methylethyl)benzeneacetate, its non-racemic isomer, (R)-cyano(3-
phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-methylethyl)benzeneacetate
and its diastereomers (S)-cyano(3-phenoxyphenyl)methyl-(R)-4-chloro-
[alpha]-(1-methylethyl)benzeneacetate and (R)-cyano(3-
phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, in or on food commodities as follows:.''
Currently, many crop commodities registered for esfenvalerate, the
S,S-isomer of fenvalerate, have been covered by tolerances in 40 CFR
180.379 for fenvalerate, a racemic mixture of four stereoisomers (the
S,S; R,S; S,R; and R,R isomers). However, as described earlier in this
document, EPA is proposing to revoke fenvalerate tolerances. Therefore,
EPA is proposing to establish separate tolerances for esfenvalerate in
40 CFR 180.533 as described below.
Based on the available bridging data from fenvalerate that compared
residues of fenvalerate with esfenvalerate for certain crop commodities
and using a tiered approach of residue conversion, EPA determined that
fenvalerate tolerances less than 1.0 ppm should be established for
esfenvalerate at levels that remain unchanged due to the increased
variability in analytical data as the limit of quantitation is
approached. Therefore, the Agency is proposing to establish tolerances
in newly recodified 40 CFR 180.533(a)(1) for combined esfenvalerate
residues of concern on almond at 0.2 ppm; bean, dry, seed at 0.25 ppm;
carrot, roots at 0.5 ppm; cauliflower at 0.5 ppm; corn, field, grain at
0.02 ppm; corn, pop, grain at 0.02 ppm; corn, sweet, kernel plus cob
with husks removed at 0.1 ppm; cotton, undelinted seed at 0.2 ppm;
cucumber at 0.5 ppm; hazelnut at 0.2 ppm; lentil, seed at 0.25 ppm;
pea, dry, seed at 0.25 ppm; peanut at 0.02 ppm; pecan at 0.2 ppm;
potato at 0.02 ppm; radish, roots at 0.3 ppm; soybean, seed at 0.05
ppm; squash, summer at 0.5 ppm; turnip, roots at 0.5 ppm; and walnut at
0.2 ppm.
Based on the available bridging data from fenvalerate that compared
residues of fenvalerate with esfenvalerate for certain crop commodities
and using a tiered approach of residue conversion, EPA determined that
fenvalerate tolerances that range from 1.0 to 2.0 ppm should be
established for esfenvalerate at levels divided by 2. Therefore, the
Agency is proposing to establish tolerances in newly recodified 40 CFR
180.533(a)(1) for combined esfenvalerate residues of concern on apple
at 1.0 ppm; bean, snap, succulent at 1.0 ppm; broccoli at 1.0 ppm;
cantaloupe at 0.5 ppm; eggplant at 0.5 ppm; melon, honeydew at 0.5 ppm;
muskmelon at 0.5 ppm; pea, succulent at 0.5 ppm; pear at 1.0 ppm;
pepper at 0.5 ppm; pumpkin at 0.5 ppm; squash, winter at 0.5 ppm;
sugarcane, cane at 1.0 ppm; sunflower, seed at 0.5 ppm; tomato at 0.5
ppm; and watermelon at 0.5 ppm.
Based on the available bridging data from fenvalerate that compared
residues of fenvalerate with esfenvalerate for certain crop commodities
and using a tiered approach of residue conversion, EPA determined that
fenvalerate tolerances greater than 2.0 ppm should be established for
esfenvalerate at levels divided by 3 and rounded to the nearest whole
number. Therefore, the Agency is proposing to establish tolerances in
newly recodified 40 CFR 180.533(a)(1) for combined esfenvalerate
residues of concern on almond, hulls at 5.0 ppm; blueberry at 1.0 ppm;
cabbage, except chinese cabbage at 3.0 ppm; caneberry subgroup 13A at
1.0 ppm; collards at 3.0 ppm; elderberry at 1.0 ppm; fruit, stone,
group 12 at 3.0 ppm; gooseberry at 1.0 ppm; radish, tops at 3.0 ppm;
and turnip, tops at 7.0 ppm.
Based on the available bridging data from fenvalerate that compared
residues of fenvalerate with esfenvalerate for corn and using a tiered
approach of residue conversion, the Agency determined that tolerances
should be established for combined esfenvalerate residues of concern on
the forage of field and sweet corn and the stover of field, pop, and
sweet corn, each at 15.0 ppm. Therefore, the Agency is proposing to
establish tolerances in newly recodified 40 CFR 180.533(a)(1) for
combined esfenvalerate residues of concern on corn, field, forage at
15.0 ppm; corn, field, stover at 15.0 ppm; corn, pop, stover at 15.0
ppm; corn, sweet, forage at 15.0 ppm; and corn, sweet, stover at 15.0
ppm.
In order to cover potential secondary residues in or on milk and
ruminant tissues which could result from registered uses of
esfenvalerate on many livestock feed items and livestock premises, and
because the ruminant metabolism of esfenvalerate is similar to
fenvalerate, EPA determined that animal commodity tolerances for
esfenvalerate should be established at levels which match the existing
tolerances for fenvalerate. Therefore, the Agency is proposing to
establish tolerances in 40 CFR 180.533(a)(1) on cattle, fat; cattle,
meat; cattle, meat byproducts; goat, fat; goat, meat; goat, meat
byproducts; hog, fat; hog, meat; hog, meat byproducts; horse, fat;
horse, meat; horse, meat byproducts; sheep, fat; sheep, meat; and
sheep, meat byproducts; each at 1.5 ppm; in milk at 0.3 ppm; and in
milk, fat at 7.0 ppm.
Based on a petition with data submitted by the Interregional
Research Project No. 4 (IR-4) in support of the use of esfenvalerate on
sweet potatoes that showed residues of concern at <0.05 ppm, EPA
determined that a tolerance should be established at 0.05 ppm.
Therefore, the Agency is proposing to establish a tolerance in 40 CFR
180.533(a)(1) on sweet potato, roots at 0.05 ppm.
Also, based on a petition with data submitted by IR-4 in support of
a regional registration (east of the Mississippi River only) for use of
esfenvalerate on bok choy that showed residues of concern at <1.0 ppm,
EPA determined that a regional tolerance should be established at 1.0
ppm. Therefore, the Agency is proposing to establish a regional
tolerance in 40 CFR 180.533(c) on cabbage, chinese, bok choy at 1.0
ppm.
In addition, based on a petition with data submitted by IR-4
regarding bulk food storage areas and in support of postharvest uses of
esfenvalerate on stored almonds, cacao beans, peanuts, and walnuts that
showed residues of concern as high as 43.48 ppm, 0.79 ppm, 0.11 ppm and
13.05 ppm, respectively, on samples collected from exposed surface
sections of sacks (samples from interior sections of sacks were mostly
non-detectable; i.e., <0.1 ppm), EPA determined that postharvest
tolerances should be established on almond, postharvest at 50 ppm;
cacao bean, postharvest at 1.0 ppm; peanut, postharvest at 0.20 ppm;
and walnut, postharvest at 15 ppm. However, the petitioner needs to
submit a revised Section B to limit number of consecutive daily spray
applications to 270 days and specify a retreatment interval of 3-4 days
when the proposed formulation is used for space treatments of food-
handling establishments other than on stored almonds, cacao beans,
peanuts, and walnuts. Therefore, the Agency is not taking action to
establish such postharvest tolerances at this time.
Moreover, based on a petition with data submitted by IR-4 in
support of a regional registration (for use of esfenvalerate on
Brussels sprouts grown in all states except California) that showed
esfenvalerate residues of concern as high as 0.141 ppm, EPA determined
that a postharvest tolerance should be established at 0.20 ppm.
Provided that the use of esfenvalerate on Brussels sprouts is limited
to the EPA-defined growing regions represented by Arkansas (Region 4)
and North Carolina (Region 2), no additional field trials are required.
However, the petitioner did
[[Page 80324]]
not specify the minimum spray volumes for ground versus aerial
equipment applications, and this information is required since the
amount of spray volumes as well as equipment types can affect the
magnitude of residues. Therefore, the Agency is not taking action to
establish such a tolerance for Brussels sprouts at this time.
There are Codex MRLs for residues of esfenvalerate on eggs; poultry
meat; and poultry, edible offal.
4. Ethylene oxide. Because there are no active registrations for
use of ethylene oxide on coconut, EPA determined that the tolerance on
coconut, copra is no longer needed and should be revoked. Consequently,
the Agency is proposing to revoke the tolerance in 40 CFR 180.151(a) on
coconut, copra.
EPA has determined that the tolerance on processed spices at 50 ppm
in 40 CFR 180.151(a)(2) should be reassigned with the tolerance on
whole spices at 50 ppm in 40 CFR 180.151(a)(1), as one tolerance termed
herbs and spices, group 19, dried (except basil), and should be lowered
to 7 ppm based on a reevaluation of a single chamber process that
showed much lower residue levels. Therefore, the Agency is proposing to
revoke the tolerances on processed (ground) spices in 40 CFR
180.151(a)(2) and the tolerance on spices, whole in 40 CFR
180.151(a)(1), and establish a tolerance in 40 CFR 180.151(a)(1) on
herb and spice, group 19, dried, except basil at 7 ppm.
Based on data for spices/herbs and single chamber treatment
process, EPA determined that a tolerance should be established on dried
vegetables at 7 ppm, provided that label amendments are made as
described above. Therefore, the Agency is proposing to establish a
tolerance in 40 CFR 180.151(a)(1) for residues of ethylene oxide in or
on vegetable, dried at 7 ppm.
Currently in 40 CFR 180.151(a)(2), there are prescribed conditions
of use for ethylene oxide. The Agency believes that these current
sections in 40 CFR 180.151(a)(2) should be removed because all
treatment parameters should be on the label. Ethylene chlorohydrin is a
reaction product that results from the fumigation of foods with
ethylene oxide due to interaction of the ethylene oxide with natural
chlorides present in the crop. Based on spice sterilization data and a
refined probabilistic acute dietary assessment for all supported
ethylene oxide food uses, the Agency concluded that ethylene
chlorohydrin is a residue of concern and should have tolerances.
Therefore, EPA is proposing to remove existing paragraph (a)(2) and
establish a tolerance expression in newly revised 40 CFR 180.151(a)(2)
as follows: ``Tolerances are established for residues of the ethylene
oxide reaction product, 2-chloroethanol, commonly referred to as
ethylene chlorohydrin, when ethylene oxide is used as a postharvest
fumigant in or on food commodities as follows:.''
Also, EPA is proposing to establish tolerances in 40 CFR
180.151(a)(2) for ethylene chlorohydrin on herb and spice, group 19,
dried, except basil at 940 ppm and vegetable, dried at 940 ppm.
In addition, EPA is proposing to revise commodity terminology to
conform to current Agency practice as follows: in 40 CFR 180.151(a)(1),
``walnut, black'' to ``walnut.''
There are no Codex MRLs for residues of ethylene oxide or ethylene
chlorohydrin in or on spices/herbs. A Canadian MRL exists for ethylene
chlorohydrin on spices at 1,500 ppm. There is no Canadian MRL for
ethylene oxide on spices/herbs. However, because the U.S. residue data
showed slightly lower levels of ethylene chlorohydrin, the Agency is
proposing a 940 ppm tolerance.
5. Fenvalerate. Fenvalerate is a racemic mixture of four
stereoisomers (the S,S; R,S; S,R; and R,R isomers). On August 5, 2004
(69 FR 47437) (FRL-7369-5), EPA issued a cancellation order for all
technical registrations for fenvalerate that permitted one technical
registrant to sell and distribute existing stocks until March 27, 2004
and the other technical registrant to sell and distribute existing
stocks until April 1, 2004. Since then, in the Federal Register of
April 30, 2008 (73 FR 23457) (FRL-8363-5), EPA issued a notice
regarding EPA's announcement of the receipt of requests from end-use
registrants to voluntarily cancel certain registrations for
fenvalerate, cyano(3-phenoxyphenyl)methyl-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, which would terminate the last fenvalerate
products registered for use in the United States. EPA approved the
cancellations effective on July 9, 2008, and permitted the registrants
to sell and distribute product under the previously approved labeling
for a period of 1 year from the date of the cancellation request (which
ranged from August 29, 2007 through April 2, 2008), i.e., until April
2, 2009 for the last end-use registrations. These last registrations
were for uses associated with agricultural, pet care, domestic home and
garden, and commercial/industrial/food sites and non-food/mosquito
abatement. The Agency believes that end users will have had sufficient
time to exhaust existing stocks and for the fenvalerate-treated food
commodities to have cleared the channels of trade by April 2, 2010.
Therefore, EPA is proposing to revoke the tolerances in 40 CFR
180.379(a)(1) on almond, hulls; almond; apple; artichoke, globe; bean,
dry, seed; bean, snap, succulent; broccoli; blueberry; cabbage;
caneberry subgroup 13A; cantaloupe; carrot, roots; cattle, fat; cattle,
meat byproducts; cattle, meat; cauliflower; collards; corn, grain;
corn, forage; corn, stover; corn, sweet, kernel plus cob with husks
removed; cotton, undelinted seed; cucumber; currant; eggplant;
elderberry; fruit, stone; goat, fat; goat, meat byproducts; goat, meat;
gooseberry; hazelnut; hog, fat; hog meat byproducts; hog, meat; horse,
fat; horse, meat byproducts; horse, meat; huckleberry; melon, honeydew;
milk; milk, fat; muskmelon; peanut; pear; pea; pea, dry, seed; pecan;
pepper; potato; pumpkin; radish, roots; radish, tops; sheep, fat;
sheep, meat byproducts; sheep, meat; soybean; squash, summer; squash,
winter; sugarcane, cane; sunflower, seed; tomato; turnip, greens;
turnip, roots; walnut; and watermelon; each with an expiration/
revocation date of April 2, 2010. Also, EPA is proposing to revoke the
tolerance in 40 CFR 180.379(a)(3) on soybean, hulls and the regional
tolerance in 40 CFR 180.379(c) on okra. In addition, EPA is proposing
to revoke a tolerance on raw agricultural food commodities (other than
those food commodities already covered by a higher tolerance as a
result of use on growing crops) at 0.05 ppm in 40 CFR 180.379(a)(2) for
residues of fenvalerate and esfenvalerate as a result of use in food-
handling establishments. A separate tolerance for use of esfenvalerate
in food-handling establishments is proposed by the Agency to be
established in 40 CFR 180.533(a)(2) as described earlier in this
document.
Due to the proposed tolerance revocations herein, EPA is proposing
to revise the section heading in 40 CFR 180.379 from cyano(3-
phenoxyphenyl)methyl-4-chloro-[alpha]-(1-methylethyl)benzeneacetate to
that of fenvalerate, remove the table in paragraph (c) and reserve
paragraph (c), remove paragraphs (a)(2) and (a)(3), revise paragraph
(a)(1) into (a) and the introductory text containing the tolerance
expression in newly recodified 40 CFR 180.379(a) to read as follows:
``Tolerances are established for residues of the insecticide
fenvalerate, cyano(3-phenoxyphenyl)methyl-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, in or on food commodities as follows.''
Also, EPA is proposing to revise commodity terminology to conform
to current Agency practice in 40 CFR
[[Page 80325]]
180.379(a) from ``corn, forage'' to ``corn, field, forage'' and ``corn,
sweet, forage;'' ``corn, grain'' to ``corn, field, grain'' and ``corn,
pop, grain;'' ``corn, stover'' to ``corn, field, stover,'' ``corn, pop,
stover,'' and ``corn, sweet, stover;'' ``fruit, stone'' to ``fruit,
stone, group 12;'' ``soybean'' to ``soybean, seed;'' and ``turnip,
greens'' to ``turnip, tops.''
Currently, there are existing Codex MRLs for fenvalerate residues
on beans, shelled at 0.1 mg/kg; beans, except broad bean and soya bean
at 1 mg/kg; berries and other small fruits at 1 mg/kg; broccoli at 2
mg/kg; cabbages, head at 3 mg/kg; cauliflower at 2 mg/kg; cereal grains
at 2 mg/kg; cherries at 2 mg/kg; cottonseed at 0.2 mg/kg; cucumber at
0.2 mg/kg; edible offal (mammalian) at 0.02 mg/kg; fat of meat (from
mammals other than marine mammals) at 1 mg/kg; melons, except
watermelon at 0.2 mg/kg; milks at 0.1 mg/kg; peach at 5 mg/kg; peanut,
whole at 0.1 mg/kg; peas, shelled (succulent seeds) at 0.1 mg/kg;
peppers, chili (dry) at 5 mg/kg; peppers, sweet at 0.5 mg/kg; pome
fruits at 2 mg/kg; root and tuber vegetables at 0.05 mg/kg; soya bean
(dry) at 0.1 mg/kg; squash, summer at 0.5 mg/kg; sunflower seed at 0.1
mg/kg; sweet corn (corn-on-the-cob) at 0.1 mg/kg; tomato at 1 mg/kg;
watermelon at 0.5 mg/kg; tree nuts at 0.2 mg/kg; and winter squash at
0.5 mg/kg.
6. 1-Naphthaleneacetic acid. Currently, tolerances in 40 CFR
180.155(a) are established for residues of 1-naphthaleneacetic acid, in
40 CFR 180.155(b) for residues of the ethyl ester of 1-
naphthaleneacetic acid, and in 40 CFR 180.309 for combined residues of
[alpha]-naphthaleneacetamide and its metabolite [alpha]-
naphthaleneacetic acid (calculated as [alpha]-naphthaleneacetic acid).
However, the Agency has determined the residues of concern are 1-
naphthaleneacetic acid and its conjugates and therefore that the
introductory text in 40 CFR 180.155(a) should be revised for residues
of 1-naphthaleneacetic acid and its conjugates calculated as 1-
naphthaleneacetic acid that result from application of the acid, its
ammonium, sodium, or potassium salts, ethyl ester, or acetamide.
Therefore, while tolerances on apple, pear, and olive should be
proposed at reassessed levels in 40 CFR 180.155(a), separate tolerances
on apple, pear, and olive in 40 CFR 180.155(b) and on apple and pear in
40 CFR 180.309 are no longer needed and should be revoked.
Consequently, EPA is proposing to revoke the tolerances on apple, pear,
and olive in 40 CFR 180.155(b) and revise and reserve that paragraph
for tolerances with section 18 emergency exemptions. Also, EPA is
proposing to revoke the tolerances on apple and pear in 40 CFR 180.309,
and remove that section. In addition, EPA is proposing to revise the
introductory text in 40 CFR 180.155(a) as follows: ``Tolerances are
established for the combined residues of the plant growth regulator 1-
naphthaleneacetic acid and its conjugates calculated as 1-
naphthaleneacetic acid from the application of 1-naphthaleneacetic
acid, its ammonium, sodium, or potassium salts, ethyl ester, and
acetamide in or on food commodities as follows:.''
Because tolerances for residues of 1-naphthaleneacetic acid by
application of its various forms will be combined into one introductory
text in 40 CFR 180.155(a), 40 CFR 180.3(d)(7), which states that the
total amount of residues for [alpha]-naphthaleneacetamide and/or
[alpha]-naphthaleneacetic acid on the same raw agricultural commodity
shall not exceed more residue than that permitted by the higher of the
two tolerances, is no longer needed and therefore 40 CFR 180.3(d)(7)
should be removed. Consequently, EPA is proposing to remove the current
40 CFR 180.3(d)(7) and redesignate current 40 CFR 180.3(d)(8) through
(d)(13) as 40 CFR 180.3(d)(7) through (d)(12), respectively.
Based on available field trial data that showed combined
naphthaleneacetic acid residues of concern in or on apples and pears as
high as 0.06 ppm and 0.03 ppm, respectively, EPA determined that the
tolerances on apple, pear, and quince in 40 CFR 180.155(a) should be
decreased from 1 to 0.1 ppm and revised into a crop group tolerance
entitled fruit, pome, group 11. Therefore, EPA is proposing to decrease
the tolerances on apple, pear, and quince in 40 CFR 180.155(a) to 0.1
ppm and revise them into fruit, pome, group 11.
Based on available field trial data that showed
combinednaphthaleneacetic acid residues of concern in or on olives as
high as 0.61 ppm, EPA determined that the tolerances on olive in 40 CFR
180.155(a) should be increased from 0.1 to 0.7 ppm. Therefore, EPA is
proposing to increase the tolerance on olive in 40 CFR 180.155(a) to
0.7 ppm. The Agency determined that the increased tolerance is safe;
i.e., there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue. Also, EPA is
proposing to remove the ``(N)'' designation from the tolerance on olive
in 40 CFR 180.155(a) to conform to current Agency administrative
practice, where the ``(N)'' designation means negligible residue.
Also, in accordance with current Agency practice, EPA is proposing
to revise 40 CFR 180.155 by adding separate paragraphs (c), and (d),
and reserving those sections for tolerances with regional registrations
and indirect or inadvertent residues, respectively.
In addition, EPA is proposing to revise commodity terminology to
conform to current Agency practice in 40 CFR 180.155(a) from ``orange,
sweet'' to ``orange.'' Also, in order to reflect that there are no U.S.
registrations, but only support for importation, EPA is proposing to
footnote the pineapple tolerance and revise it from ``pineapple (from
the application of the sodium salt to the growing crop)'' to
``pineapple.''
There are no Codex MRLs for residues of 1-naphthaleneacetic acid,
its salts, ester, and acetamide.
7. Phosalone. In the Federal Register of October 26, 1998 (63 FR
57062) (FRL-6035-8), EPA responded to a comment from Rhone-Poulenc Ag
Company, which requested that the Agency not revoke tolerances for
phosalone on almonds; apricots; apples; cherries; grapes; peaches;
pears; and plums/prunes in order to maintain them for importation
purposes, by not revoking those tolerances at that time. Later, after a
merger, Rhone-Poulenc Ag Company became Aventis CropScience, and was
eventually acquired by Bayer CropScience, which later entered into an
agreement that transferred the global rights of phosalone to Cheminova.
On April 30, 2008, Cheminova notified EPA that for commercial reasons
it will not develop the requested data to support the phosalone import
tolerances. However, Cheminova urged the Agency to prevent trade
irritants and consider that Canada is phasing out the use of phosalone.
Health Canada's Pest Management Regulatory Agency (PMRA) has scheduled
a last date of application for phosalone on apple; cherry; grape;
peach; pear; and plum/prune as September 30, 2012, with the earliest
date for amending (revoking) its MRLs as September 30, 2013. This
information is found on PMRA's website at https://www.pmra-arla.gc.ca/
english/pdf/rev/rev2008-02-e.pdf. Therefore, EPA is proposing to revoke
the tolerances in 40 CFR 180.263 on apple; cherry; grape; peach; pear;
and plum, prune, fresh; each with an expiration date of September 30,
2013. In addition, EPA is proposing to revoke the tolerances in 40 CFR
180.263 on almond and apricot effective on the day of publication of
the final rule in the Federal Register.
In accordance with current Agency practice, EPA is proposing to
revise 40 CFR 180.263 by adding separate paragraphs (b), (c), and (d),
and reserving those sections for tolerances
[[Page 80326]]
with section 18 emergency exemptions, regional registrations, and
indirect or inadvertent residues, respectively.
There are Codex MRLs for residues of phosalone on almonds, pome
fruits, and stone fruits.
8. Phosmet, N-(Mercaptomethyl)phthalimide S-(O,O-dimethyl