Methamidophos, Oxydemeton-methyl, Profenofos, and Trichlorfon; Proposed Tolerance Actions, 28912-28920 [07-2561]
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Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Proposed Rules
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0261; FRL–8130–8]
Methamidophos, Oxydemeton-methyl,
Profenofos, and Trichlorfon; Proposed
Tolerance Actions
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
SUMMARY: EPA is proposing to revoke
certain tolerances for the insecticides
methamidophos and oxydemetonmethyl. Also, EPA is proposing to
modify certain tolerances for the
insecticides methamidophos,
oxydemeton-methyl, profenofos, and
trichlorfon. In addition, EPA is
proposing to establish new tolerances
for the insecticides methamidophos and
profenofos. 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).
Comments must be received on
or before July 23, 2007.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2007–0261, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
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’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–2007–
0261. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
www.regulations.gov, including any
personal information provided, unless
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DATES:
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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 Federal regulations.gov
website is an ‘‘anonymous access’’
system, which 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 email 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
in regulations.gov. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
web site to view the docket index or
access available documents. 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
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Ave, NW., Washington, DC 20460–0001;
telephone number: (703) 308–8037; email 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).
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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.
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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 time frames 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, remove,
modify, and establish specific tolerances
for residues of the insecticides
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methamidophos, oxydemeton-methyl,
profenofos, and trichlorfon in or on
commodities listed in the regulatory
text.
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 the 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: 1 (800)
490–9198; fax: 1 (513) 489–8695;
internet at https://www.epa.gov/
ncepihom/ and from the National
Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA
22161, telephone: 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. The methamidophos,
oxydemeton-methyl, and profenofos
REDs and triclorfon TRED are found 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:
(1) Lawful use (sometimes through a
label change) may result in a higher
residue level on the commodity.
(2) The tolerance remains safe,
notwithstanding increased residue level
allowed under the tolerance. In REDs,
Chapter IV on ‘‘Risk management,
Reregistration, and Tolerance
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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 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. Copies of
the Residue Chemistry Chapter
documents are found in the
Administrative Record and paper copies
for methamidophos, oxydemetonmethyl, profenofos, and trichlorfon are
available in the public docket for this
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 number EPA–HQ–
OPP–2007–0261, then click on that
docket 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
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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
domestic commodities legally treated.
1. Methamidophos. Because
methamidophos is a metabolite of
acephate, EPA determined that residues
of methamidophos resulting from the
application of acephate should be
included under the tolerance
regulations for methamidophos as a
pesticide. Therefore, EPA is proposing
to recodify the tolerances for
methamidophos from 40 CFR 180.315(a)
into (a)(1) for permanent tolerances for
residues of methamidophos (O,Sdimethyl phosphoramidothioate) in or
on food commodities as a result of the
application of the insecticide
methamidophos and (a)(2) for residues
of methamidophos (O,S-dimethyl
phosphoramidothioate) in or on food
commodities as a result of the
application of the insecticide acephate.
Currently, 40 CFR 180.3, the section
on tolerances for related pesticide
chemicals, contains a paragraph (d)(8)
stating that where tolerances are
established for residues of O,S-dimethyl
phosphoramidothioate, resulting from
the use of acephate (O,S-dimethyl
acetylphos-phoramidothioate) and/or
O,S-dimethylphosphoramidothioate on
the same agricultural commodity, the
total amount of O,S-dimethylphosphoramidothioate shall not yield
more residue than that permitted by the
higher of the two tolerances. However,
with the proposed change to include
tolerances for methamidophos that
result from the application of acephate
under the methamidophos tolerance
regulations in 40 CFR 180.315(a)(2),
there is no longer a need for the related
pesticide chemical regulation under 40
CFR 180.3(d)(8); and therefore, EPA is
proposing to remove existing paragraph
(d)(8).
With the exception of uses on cotton
and potatoes, EPA canceled all
methamidophos FIFRA section 3
registrations and, with the exception of
uses on tomatoes, all section 24(c)
regional registrations (62 FR 67071,
December 23, 1997) (FRL–5764–2).
Because there are no active registrations
for uses of either methamidophos or
acephate on broccoli, cabbage,
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cucumber, eggplant, and melon, the
associated tolerances in 40 CFR 180.315
are no longer needed and should be
revoked. Therefore, EPA is proposing to
revoke the tolerances in 40 CFR 180.315
on broccoli, cabbage, cucumber,
eggplant, and melon. Also, on July 31,
2002 (67 FR 49606)(FRL–7191–4), EPA
published a final rule in the Federal
Register in which it responded to the
Canadian Horticultural Council’s
comment asking that certain tolerances
in 40 CFR 180.315, including those on
broccoli and cabbage, not be revoked. At
that time, the Agency responded that it
would not revoke the tolerances on
broccoli and cabbage in 40 CFR 180.315,
but would follow-up to see that data
requirements were met should an
interested party support those
tolerances for import purposes.
However, in the interim period, no
interested party has declared an interest
and committed in writing to do the
required data to support the broccoli
and cabbage tolerances for import
purposes.
However, because there are registered
acephate uses on Brussels sprouts,
cauliflower, celery, and head lettuce,
EPA is proposing to recodify the
tolerances for Brussels sprouts,
cauliflower, and lettuce from 40 CFR
180.315(a) into (a)(2) and celery from (b)
into (a)(2). Also, in order to reflect
active registered use of acephate on
head lettuce, EPA is proposing in 40
CFR 180.315(a)(2) to revise ‘‘lettuce’’ to
‘‘lettuce, head.’’ In addition, because
there is an existing tolerance for
acephate use on cauliflower, which has
been reassessed in the acephate RED at
the same level, such that residues from
metabolism to methamidophos are
expected to be no greater than 0.5 parts
per million (ppm), EPA is proposing to
decrease the tolerance on cauliflower in
40 CFR 180.315(a)(2) from 1.0 to to 0.5
ppm. Also, this proposed level will
harmonize with the Codex MRL of 0.5
mg/kg on cauliflower.
At the time of the completion of the
methamidophos IRED, a registrant
submitted an import tolerance petition
for peppers, strawberries, and squash.
This petition has not been reviewed.
Because there is an existing tolerance
for acephate use on peppers, which in
the acephate RED has been reassessed at
the same level, such that residues from
metabolism to methamidophos are
expected to be no greater than 1.0 ppm,
EPA is proposing to recodify the
tolerance on pepper from 40 CFR
180.315(a) to (a)(2) at 1.0 ppm. Also,
this proposed level will harmonize with
the Codex MRL of 1.0 mg/kg on sweet
peppers.
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Because there are registered
methamidophos uses on potato, EPA is
proposing to recodify the tolerance at
0.1 ppm on potato from 40 CFR
180.315(a) into (a)(1). There is a Codex
MRL of 0.05 ppm on potato, but
harmonization is not possible because of
differences in agricultural practices.
Based on available data that showed
methamidophos residues as high as
0.191 ppm on cottonseed, EPA
determined that the tolerance on
cottonseed should be increased from 0.1
to 0.2 ppm. Therefore, the Agency is
proposing to recodify the tolerance on
cotton, undelinted seed from 40 CFR
180.315(a) to (a)(1) and increase the
tolerance to 0.2 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. Also, this proposed
level will harmonize with the Codex
MRL of 0.2 mg/kg on cottonseed.
Based on available data that showed
methamidophos residues as high as 8.03
ppm on cotton gin byproducts, EPA
determined that a tolerance on cotton
gin byproducts should be established at
10.0 ppm. Therefore, the Agency is
proposing to establish a tolerance on
cotton, gin byproducts in 40 CFR
180.315(a)(1) at 10.0 ppm.
Based on available data that showed
methamidophos residues as high as 1.4
ppm on tomatoes, EPA determined that
the tolerance on tomato should be
increased from 1.0 to 2.0 ppm. Because
there are only active FIFRA section
24(c) registrations for use of
methamidophos on tomatoes and no
active registrations for use of acephate
on tomatoes, the Agency has determined
that the tolerance should be recodified
as a regional tolerance. Therefore, the
Agency is proposing to recodify 40 CFR
180.315(b) as (c) and the tolerance on
tomato from 40 CFR 180.315(a) to (c),
and increase the tolerance to 2.0 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 revise the tolerance
expression in newly recodified 40 CFR
180.315(c), as follows:
Tolerances with regional registration,
as defined in 40 CFR 180.1(m), are
established for residues of
methamidophos (O,S-dimethyl
phosphoramidothioate) in or on the
following food commodities as a result
of the application of the insecticide
methamidophos.
In addition, EPA is proposing to
revise 40 CFR 180.315 by adding
separate paragraphs (b) and (d), and
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reserving those sections for tolerances
with section 18 emergency exemptions,
and indirect or inadvertent residues,
respectively.
Because there are existing tolerances
for use of acephate on dry and succulent
beans and cranberries, which in the
acephate RED have been reassessed at
the same level, such that residues from
metabolism to methamidophos are
expected to be no greater than 1.0 ppm
and 0.1 ppm, respectively, EPA is
proposing to establish tolerances in 40
CFR 180.315(a)(2) for residues of
methamidophos as a result from the
application of acephate on bean, dry,
seed at 1.0 ppm, bean, succulent at 1.0
ppm, and cranberry at 0.1 ppm.
Because there is an existing tolerance
for use of acephate on mint hay, which
in the acephate RED has been reassessed
to be increased from 15.0 to 27.0 ppm,
such that residues from metabolism to
methamidophos are expected to be
increased from no greater than 1.0 to 2.0
ppm, EPA is proposing to establish a
tolerance in 40 CFR 180.315(a)(2) for
residues of methamidophos as a result
from the application of acephate on
mint, hay at 2.0 ppm and revise it to
‘‘peppermint, tops’’ and ‘‘spearmint,
tops.’’
2. Oxydemeton-methyl. Currently, the
tolerances in 40 CFR 180.330 are
expressed for residues of oxydemetonmethyl and its cholinesterase-inhibiting
metabolites. Based on the Agency’s
determination that only residues of
oxydemeton-methyl and its metabolite
oxydemeton-methyl sulfone are of
concern in plants, the tolerances in 40
CFR 180.330 should be recodified for
plant commodities from 40 CFR
180.330(a) to (a)(1) and animal
commodities from 40 CFR 180.330(a) to
(a)(2). Therefore, EPA is proposing to
recodify plant tolerances in 40 CFR
180.330(a)(1) and animal tolerances in
40 CFR 180.330(a)(2) and revise the
tolerance expression in 40 CFR 180.330
as follows:
(a) General. (1) Tolerances are established
for the combined residues of the insecticide
oxydemeton-methyl (S-(2-(ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate) and
its metabolite oxydemeton-methyl sulfone in
or on the following food commodities.
(2) Tolerances are established for the
combined residues of the insecticide
oxydemeton-methyl (S-(2-(ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate) and
its cholinesterase-inhibiting metabolites in or
on the following food commodities.
Because certain registered uses have
product labels which prohibit harvest
within one year of application, so that
there is no reasonable expectation of
residues on food commodities, the
Agency considers them to be nonfood
uses of oxydemeton-methyl. As a result,
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the tolerances in 40 CFR 180.330 for
these nonfood uses are no longer needed
and should be revoked for apple,
apricot, grape, and plum, prune, fresh.
Therefore, the Agency is proposing to
revoke the tolerances in 40 CFR
180.330(a) on apple, grape, and plum,
prune, fresh and in 40 CFR 180.330(c)
on apricot.
Because bean, lima, forage; clover,
seed screenings; and sorghum milled
fractions (except flour) are no longer
considered by the Agency to be
significant animal feed items, their
tolerances in 40 CFR 180.330 are no
longer needed and should be revoked.
Therefore, the Agency is proposing to
revoke the tolerances in 40 CFR 180.330
on bean, lima, forage; clover, seed
screenings; and sorghum, milled
fractions (except flour).
In 1994, the technical registrant for
oxydemeton-methyl (ODM) agreed not
to market ODM on snap beans, field
corn, popcorn, pears, and turnips but
retained them on registrations with the
possibility of requesting to reinstate
them on marketing labels after EPA’s
review of needed ODM data and
completion of dietary and worker risk
assessments. In a letter to the Agency
dated February 4, 2004, the technical
registrant requested to amend the
registrations for both a technical and
end-use registration and delete those
uses. In the Federal Register of
November 4, 2005 (70 FR 67167) (FRL–
7744–7), EPA published a notice
announcing the receipt of requests for
amendments to delete uses in certain
pesticide registrations, including
deletion for ODM use on snap beans,
field corn, popcorn, pears, and turnips
concerning registrations for one
technical and one end use product. That
notice had an effective date of December
5, 2005 and allowed the registrant to sell
or distribute product under the
previously approved labelling for a
period of 18 months after approval of
the revision. There have been no end
use marketing labels for ODM use on
these commodities since September 18,
1995. However, there has been one
active technical registration with these
uses from 1995 through the December 5,
2005 effective date that amended its
label. Nevertheless, despite the
allowance by EPA that existing stocks
for the technical and end use
registrations could be sold or distributed
by the registrant for 18 months, the
Agency believes that no end users have
used ODM on snap beans, field corn,
popcorn, pears, and turnip commodities
since 1995. Therefore, EPA believes that
existing stocks of end use product was
exhausted years ago and that such ODM
treated-snap beans, field corn, popcorn,
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pears, and turnip commodities passed
through channels of trade long ago and
that sufficient time has passed.
Consequently, EPA is proposing to
revoke the tolerances in 40 CFR 180.330
on bean, snap, succulent; bean, snap,
forage; corn, grain; pear; turnip; and
turnip, greens; all on the date of
publication of the final rule.
Based on available data that showed
combined oxydemeton-methyl residues
of concern as high as 0.9 ppm in or on
corn forage, EPA determined that the
tolerance on corn forage should be
decreased from 3.0 to 1.0 ppm.
Therefore, the Agency is proposing in
40 CFR 180.330 to decrease the
tolerance on corn, forage to 1.0 ppm and
revise it to corn, sweet, forage. No
tolerance on field corn forage is needed.
Based on available data that showed
combined oxydemeton-methyl residues
of concern as high as 9.84 ppm in or on
clover hay grown for seed, EPA
determined that the tolerance on clover
hay grown for seed should be decreased
from 11.0 to 10.0 ppm. Therefore, the
Agency is proposing in 40 CFR 180.330
to decrease the tolerance on clover, hay,
grown for seed to 10.0 ppm and revise
it to clover, hay.
Based on available data that showed
combined oxydemeton-methyl residues
of concern as high as 0.15 ppm in or on
lima beans, 0.2 ppm in or on melons,
less than 0.1 ppm in or on pumpkins,
and less than 0.05 ppm in or on
walnuts, EPA determined that the
tolerances on lima beans, cottonseed,
melons, pumpkins, and walnuts should
be decreased from 0.5 to 0.2 ppm, 0.1
to 0.02 ppm, 0.3 to 0.2 ppm, 0.3 to 0.2
ppm, and 0.3 to 0.05 ppm, respectively.
Therefore, the Agency is proposing in
40 CFR 180.330 to decrease the
tolerances on bean, lima to 0.2 ppm,
cotton, undelinted seed to 0.02 ppm,
melon to 0.2 ppm, pumpkin to 0.2 ppm,
and walnut to 0.05 ppm.
Based on available data that showed
combined oxydemeton-methyl residues
of concern as high as 1.22 ppm in or on
cabbage, EPA determined that the
tolerance on cabbage should be
increased from 1.0 to 2.0 ppm.
Therefore, the Agency is proposing in
40 CFR 180.330 to increase the tolerance
on cabbage to 2.0 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, because there is
one active FIFRA section 24(c)
registration for foliar use of
oxydemeton-methyl on broccoli raab,
EPA determined that data could be
translated from cabbage and broccoli to
broccoli raab, and therefore a tolerance
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should be established on broccoli raab
at 2.0 ppm. Therefore, EPA is proposing
to establish a regional tolerance on
broccoli raab in 40 CFR 180.330(c) at 2.0
ppm and revise the tolerance expression
in 40 CFR 180.330(c) as follows:
(c) Tolerances with regional registrations,
as defined in 40 CFR 180.1(m), are
established for the combined residues of the
insecticide oxydemeton-methyl (S-(2(ethylsulfinyl)-ethyl) O,O-dimethyl
phosphorothioate) and its metabolite
oxydemeton-methyl sulfone in or on the
following food commodities.
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Based on a poultry metabolism study
at the 6x feeding level that showed no
residues of toxicological concern in
poultry commodities and an earlier
poultry metabolism study that showed
residues were present in eggs and
tissues, EPA determined that egg and
poultry tolerances should be established
at the limit of quantitation (LOQ) of 0.01
ppm. Therefore, the Agency is
proposing to establish tolerances in 40
CFR 180.330(a)(2) on egg; poultry, fat;
poultry, meat; and poultry, meat
byproducts at 0.01 ppm.
Also, EPA is proposing to revise
commodity terminology in 40 CFR
180.330 to conform to current Agency
practice as follows: ‘‘alfalfa, green’’ to
‘‘alfalfa, forage;’’ ‘‘alfalfa, hay, grown for
seed’’ to ‘‘alfalfa, hay;’’ ‘‘beet, sugar’’ to
‘‘beet, sugar, roots;’’ ‘‘corn, stover’’ to
‘‘corn, sweet, stover’’ (no tolerances are
needed on field corn stover or popcorn
stover) ‘‘mint, hay’’ to ‘‘peppermint,
tops’’ and ‘‘spearmint, tops;’’ ‘‘onion,
dry bulb’’ to ‘‘onion, bulb;’’ ‘‘orange,
sweet’’ to ‘‘orange;’’ ‘‘sorghum, forage’’
to ‘‘sorghum, forage, forage’’ and
‘‘sorghum, grain, forage;’’ ‘‘sorghum,
grain’’ to ‘‘sorghum, grain, grain.’’
There are no Codex MRLs for
oxydemeton-methyl.
3. Profenofos. Currently, the
tolerances in 40 CFR 180.404(a) are
expressed for residues of profenofos and
its metabolites converted to 4-bromo-2chlorophenyl and calculated as
profenofos. Based on the Agency’s
determination that only residues of
profenofos per se are of toxicological
concern, the tolerance expression in 40
CFR 180.404 should be revised to reflect
that profenofos per se is the only
regulated residue. Therefore, EPA is
proposing to revise the tolerance
expression in 40 CFR 180.404(a) as
follows:
(a) General. Tolerances are established for
residues of the insecticide profenofos (O-(4bromo-2-chlorophenyl)-O-ethyl-S-propyl
phosphorothioate) in or on the following
food commodities.
Based on available data that showed
profenofos residues were as high as 1.1
ppm on cottonseed, EPA determined
that the tolerance should be decreased
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from 3.0 to 2.0 ppm. Therefore, the
Agency is proposing to decrease the
tolerance in 40 CFR 180.404 on cotton,
undelinted seed to 2.0 ppm. Also, this
proposed level will harmonize with the
Codex MRL of 2 mg/kg on cottonseed.
Based on available data that showed
profenofos residues as high as 53 ppm,
EPA determined that a tolerance of 55.0
ppm should be established for cotton
gin byproducts. Therefore, the Agency is
proposing to establish a tolerance in 40
CFR 180.404 for the residues of
profenofos on cotton, gin byproducts at
55.0 ppm.
4. Trichlorfon. There are no active
registrations for the use of the
insecticide trichlorfon for cattle
commodities in the United States.
However, trichlorfon is used as a dermal
pour-on application for cattle for import
purposes. Based on cattle metabolism
data from dermal application of
trichlorfon which showed residues of
trichlorfon as high as 0.2 ppm in muscle
and less than 0.5 ppm in fat, EPA
determined that the tolerances on cattle
meat and cattle fat should be increased
from 0.1 ppm to 0.2 ppm and 0.1 to 0.5
ppm, respectively. Therefore, EPA is
proposing in 40 CFR 180.198 to increase
the tolerances on cattle, meat to 0.2 ppm
and cattle, fat to 0.5 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. Dichlorvos is a
degradate of trichlorfon. However, as
stated in the 2006 Dichlorvos RED, nondetectable dichlorvos residues in
livestock commodities are expected as a
result of trichlorfon use, and dichlorvos
was not a significant metabolite in the
trichlorfon dermal metabolism data.
Therefore, dietary (food) exposure to
dichlorvos residues resulting from use
of trichlorfon is considered by the
Agency to be negligible.
Also, in 40 CFR 180.198, 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. In addition,
in order to conform to current Agency
practice, EPA is proposing to revise 40
CFR 180.198 and establish subparts (a)
through (d), recodify general tolerances
under 40 CFR 180.198(a) and reserve
sections (b) for tolerances with section
18 emergency exemptions, (c) for
regional registrations, and (d) for
indirect or inadvertent residues.
There are no Codex MRLs for
trichlorfon.
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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 the 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 the FFDCA, 21 U.S.C. 342(a).
Such food may not be distributed in
interstate commerce (21 U.S.C. 331(a)).
For a food-use 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 in follow-up to the tolerance
recommendations made during the
reregistration and tolerance
reassessment processes (including
follow-up on canceled or additional
uses of pesticides). The safety finding
determination under section 408 of the
FFDCA standard 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.
EPA has issued post-FQPA REDs for
methamidophos, oxydemeton-methyl,
and profenofos, and a TRED for
trichlorfon, whose RED was completed
prior to FQPA. REDs and TREDs contain
the Agency’s evaluation of the data base
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,
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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 the 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
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
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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.
EPA has developed guidance
concerning submissions for import
tolerance support (65 FR 35069, June 1,
2000) (FRL–6559–3). This guidance will
be made available to interested persons.
Electronic copies are available on the
internet at https://www.epa.gov/. On the
Home Page select ‘‘Laws, Regulations,
and Dockets,’’ then select Regulations
and Proposed Rules and then look up
the entry for this document under
‘‘Federal Register—Environmental
Documents.’’ You can also go directly to
the ‘‘Federal Register’’ listings at https://
www.epa.gov/fedrgstr/.
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 rule 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?
EPA is proposing that the actions
herein become effective on the date of
publication of the final rule in the
Federal Register, because their
associated uses have been canceled for
several years. 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 had sufficient
time for passage 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
channels of trade following the
tolerance revocations, shall be subject to
FFDCA section 408(1)(5), as established
by FQPA. Under this section, 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 the
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
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international Maximum Residue Limits
(MRLs) established by the Codex
Alimentarius Commission, as required
by section 408(b)(4) of the FFDCA. 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,
section 408(b)(4) of FFDCA 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 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
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,
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
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15:44 May 22, 2007
Jkt 211001
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), respectively,
and were provided to the Chief Counsel
for Advocacy of the Small Business
Administration. Taking into account
this analysis, and available information
concerning the pesticides listed in this
proposed rule, the Agency hereby
certifies that this proposed action 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
pesticide 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
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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 the
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
6, 2000). Executive Order 13175,
requires EPA to develop an accountable
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.
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 16, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
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PART 180—[AMENDED]
Commodity
1. The authority citation for part 180
continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
§180.3
Lettuce, head ..................
Pepper ............................
Peppermint, tops ............
Spearmint, tops ..............
1.0
1.0
2.0
2.0
[Amended]
2. Section 180.3 is amended by
removing paragraph (d)(8) and
redesignationg paragraphs (d)(9)
through (d)(14) as paragraphs (d)(8)
through (d)(13).
3. Section 180.198 is revised to read
as follows:
§180.198 Trichlorfon; tolerances for
residues.
(a) General. Tolerances are
established for residues of the
insecticide trichlorfon (dimethyl (2,2,2trichloro-1-hydroxyethyl) phosphonate)
in or on the following food
commodities:
Commodity
0.2
0.1
are no U.S. registrations for cattle
commodities as of June 24, 1999.
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
4. Section 180.315 is revised to read
as follows:
§180.315 Methamidophos; tolerances for
residues.
(a) General. (1) Tolerances are
established for residues of
methamidophos (O,S-dimethyl
phosphoramidothioate) in or on the
following food commodities as a result
of the application of the insecticide
methamidophos.
Parts per million
Cotton, gin byproducts ...
Cotton, undelinted seed
Potato .............................
10.0
0.2
0.1
(2) Tolerances are established for
residues of methamidophos (O,Sdimethyl phosphoramidothioate) in or
on the following food commodities as a
result of the application of the
insecticide acephate.
Commodity
Parts per million
Bean, dry, seed ..............
Bean, succulent ..............
Brussels sprouts .............
Cauliflower ......................
Celery .............................
Cranberry ........................
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Commodity
Parts per million
Tomato
2.0
(d) Indirect or inadvertent residues.
[Reserved]
5. Section 180.330 is revised to read
0.5 as follows:
1There
Commodity
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. Tolerances with regional
registration, as defined in 180.1(m), are
established for residues of
methamidophos (O,S-dimethyl
phosphoramidothioate) in or on the
following food commodities as a result
of the application of the insecticide
methamidophos.
Parts per million
Cattle, fat 1 .....................
Cattle, meat 1 .................
Cattle, meat byproducts 1
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Parts per million
15:44 May 22, 2007
1.0
1.0
1.0
0.5
1.0
0.1
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§180.330 S-(2-(Ethylsulfinyl)ethyl) O,Odimethyl phosphorothioate; tolerances for
residues.
(a) General. (1) Tolerances are
established for the combined residues of
the insecticide oxydemeton-methyl (S(2-(ethylsulfinyl)-ethyl) O,O-dimethyl
phosphorothioate) and its metabolite
oxydemeton-methyl sulfone in or on the
following food commodities:
Commodity
Parts per million
Alfalfa, forage .................
Alfalfa, hay ......................
Bean, lima .......................
Beet, sugar, roots ...........
Beet, sugar, tops ............
Broccoli ...........................
Brussels sprouts .............
Cabbage .........................
Cauliflower ......................
Clover, forage .................
Clover, hay .....................
Corn, sweet, forage ........
Corn, sweet, kernel plus
cob with husks removed .........................
Corn, sweet, stover ........
Cotton, undelinted seed
Cucumber .......................
Eggplant ..........................
Filbert ..............................
Grapefruit ........................
Lemon .............................
Lettuce, head ..................
Melon ..............................
Onion, bulb .....................
Orange ............................
Pepper ............................
Peppermint, tops ............
Pumpkin ..........................
Safflower, seed ...............
Sorghum, forage, forage
Sorghum, grain, forage ...
PO 00000
Frm 00025
Fmt 4702
Sfmt 4702
5.0
11.0
0.2
0.3
0.5
1.0
1.0
2.0
1.0
5.0
10.0
1.0
Commodity
28919
Parts per million
Sorghum, grain, grain .....
Spearmint, tops ..............
Squash, summer ............
Squash, winter ................
Strawberry ......................
Walnut .............................
0.75
12.5
1.0
0.3
2.0
0.05
(2) Tolerances are established for the
combined residues of the insecticide
oxydemeton-methyl (S-(2(ethylsulfinyl)-ethyl) O,O-dimethyl
phosphorothioate) and its
cholinesterase-inhibiting metabolites in
or on the following food commodities.
Commodity
Parts per million
Cattle, fat ........................
Cattle, meat ....................
Cattle, meat byproducts
Egg .................................
Goat, fat ..........................
Goat, meat ......................
Goat, meat byproducts ...
Hog, fat ...........................
Hog, meat .......................
Hog, meat byproducts ....
Horse, fat ........................
Horse, meat ....................
Horse, meat byproducts
Milk .................................
Poultry, fat ......................
Poultry, meat ..................
Poultry, meat byproducts
Sheep, fat .......................
Sheep, meat ...................
Sheep, meat byproducts
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. Tolerances with regional
registrations, as defined in 180.1(m), are
established for the combined residues of
the insecticide oxydemeton-methyl (S(2-(ethylsulfinyl)-ethyl) O,O-dimethyl
phosphorothioate) and its metabolite
oxydemeton-methyl sulfone in or on the
following food commodities:
Commodity
Parts per million
Broccoli raab ...................
0.5
3.0
0.02
1.0
1.0
0.05
1.0
1.0
2.0
0.2
0.05
1.0
0.75
12.5
0.2
1.0
2.0
2.0
2.0
(d) Indirect or inadvertent residues.
[Reserved]
6. Section 180.404, paragraph (a) is
revised to read as follows:
§180.404 Profenofos; tolerances for
residues.
(a) General. Tolerances are
established for residues of the
insecticide profenofos (O-(4-bromo-2chlorophenyl)-O-ethyl-S-propyl
phosphorothioate) in or on the
following food commodities:
Commodity
Cattle, fat ........................
E:\FR\FM\23MYP1.SGM
23MYP1
Parts per million
0.05
28920
Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Proposed Rules
Commodity
Parts per million
Cattle, meat ....................
Cattle, meat byproducts
Cotton, gin byproducts ...
Cotton, undelinted seed
Goat, fat ..........................
Goat, meat ......................
Goat, meat byproducts ...
Horse, fat ........................
Horse, meat ....................
Horse, meat byproducts
Milk .................................
Sheep, fat .......................
Sheep, meat ...................
Sheep, meat byproducts
*
*
*
*
0.05
0.05
55.0
2.0
0.05
0.05
0.05
0.05
0.05
0.05
0.01
0.05
0.05
0.05
*
FR Doc. 07–2561 Filed 5–22–07; 8:45 am
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0766; FRL–8126–1]
[RIN 2070–AJ28]
Pesticide Tolerance Crop Grouping
Program; Proposed Expansion
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
cprice-sewell on PROD1PC71 with PROPOSALS
AGENCY:
SUMMARY: EPA is proposing revisions to
its pesticide tolerance crop grouping
regulations, which allow establishment
of tolerances for multiple related crops,
based on data from a representative set
of crops. The present revision would
create a new crop group for edible fungi
(mushrooms), expand existing crop
groups by adding new commodities,
establish new crop subgroups, and
revise the representative crops in some
groups. Additionally, EPA is revising
the generic crop group regulation to add
a subsection explaining how the Agency
will implement revisions to crop
groups. EPA expects these revisions to
promote greater use of crop groupings
for tolerance-setting purposes and, in
particular, will assist in retaining or
making available pesticides for minor
crop uses. This is the first in a series of
planned crop group updates expected to
be proposed over the next several years.
DATES: Comments must be received on
or before July 23, 2007.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2006–0766, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
VerDate Aug<31>2005
15:44 May 22, 2007
Jkt 211001
• 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 Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’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 telephone number is (703) 305–
5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2006–
0766. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line 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 Federal regulations.gov
website is an ‘‘anonymous access’’
system, which 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 email 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. 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
PO 00000
Frm 00026
Fmt 4702
Sfmt 4702
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
Building), 2777 S. Crystal Drive,
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
telephone number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
`
Rame Cromwell, Field and External
Affairs Division, Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (703) 308–9068; fax number:
(703) 305–5884; e-mail address:
cromwell.rame@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.
Potentially affected entities may
include, but are not limited to:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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. 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
www.regulations.gov or e-mail. Clearly
mark the part or all of the information
that you claim to be CBI. For CBI
E:\FR\FM\23MYP1.SGM
23MYP1
Agencies
[Federal Register Volume 72, Number 99 (Wednesday, May 23, 2007)]
[Proposed Rules]
[Pages 28912-28920]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-2561]
[[Page 28912]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0261; FRL-8130-8]
Methamidophos, Oxydemeton-methyl, Profenofos, and Trichlorfon;
Proposed Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to revoke certain tolerances for the
insecticides methamidophos and oxydemeton-methyl. Also, EPA is
proposing to modify certain tolerances for the insecticides
methamidophos, oxydemeton-methyl, profenofos, and trichlorfon. In
addition, EPA is proposing to establish new tolerances for the
insecticides methamidophos and profenofos. 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 July 23, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0261, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line 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'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-
2007-0261. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line 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 e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which 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 in regulations.gov. To access the electronic docket, go to
https://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov web
site to view the docket index or access available documents. 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).
[[Page 28913]]
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 time frames 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, remove, modify, and establish specific
tolerances for residues of the insecticides methamidophos, oxydemeton-
methyl, profenofos, and trichlorfon in or on commodities listed in the
regulatory text.
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 the 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: 1 (800) 490-9198;
fax: 1 (513) 489-8695; internet at https://www.epa.gov/ncepihom/ and
from the National Technical Information Service (NTIS), 5285 Port Royal
Road, Springfield, VA 22161, telephone: 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. The methamidophos, oxydemeton-
methyl, and profenofos REDs and triclorfon TRED are found 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:
(1) Lawful use (sometimes through a label change) may result in a
higher residue level on the commodity.
(2) 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 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. Copies of
the Residue Chemistry Chapter documents are found in the Administrative
Record and paper copies for methamidophos, oxydemeton-methyl,
profenofos, and trichlorfon are available in the public docket for this
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 number EPA-HQ-OPP-2007-
0261, then click on that docket 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
[[Page 28914]]
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 domestic commodities legally
treated.
1. Methamidophos. Because methamidophos is a metabolite of
acephate, EPA determined that residues of methamidophos resulting from
the application of acephate should be included under the tolerance
regulations for methamidophos as a pesticide. Therefore, EPA is
proposing to recodify the tolerances for methamidophos from 40 CFR
180.315(a) into (a)(1) for permanent tolerances for residues of
methamidophos (O,S-dimethyl phosphoramidothioate) in or on food
commodities as a result of the application of the insecticide
methamidophos and (a)(2) for residues of methamidophos (O,S-dimethyl
phosphoramidothioate) in or on food commodities as a result of the
application of the insecticide acephate.
Currently, 40 CFR 180.3, the section on tolerances for related
pesticide chemicals, contains a paragraph (d)(8) stating that where
tolerances are established for residues of O,S-dimethyl
phosphoramidothioate, resulting from the use of acephate (O,S-dimethyl
acetylphos-phoramidothioate) and/or O,S-dimethylphosphoramidothioate on
the same agricultural commodity, the total amount of O,S-dimethyl-
phosphoramidothioate shall not yield more residue than that permitted
by the higher of the two tolerances. However, with the proposed change
to include tolerances for methamidophos that result from the
application of acephate under the methamidophos tolerance regulations
in 40 CFR 180.315(a)(2), there is no longer a need for the related
pesticide chemical regulation under 40 CFR 180.3(d)(8); and therefore,
EPA is proposing to remove existing paragraph (d)(8).
With the exception of uses on cotton and potatoes, EPA canceled all
methamidophos FIFRA section 3 registrations and, with the exception of
uses on tomatoes, all section 24(c) regional registrations (62 FR
67071, December 23, 1997) (FRL-5764-2). Because there are no active
registrations for uses of either methamidophos or acephate on broccoli,
cabbage, cucumber, eggplant, and melon, the associated tolerances in 40
CFR 180.315 are no longer needed and should be revoked. Therefore, EPA
is proposing to revoke the tolerances in 40 CFR 180.315 on broccoli,
cabbage, cucumber, eggplant, and melon. Also, on July 31, 2002 (67 FR
49606)(FRL-7191-4), EPA published a final rule in the Federal Register
in which it responded to the Canadian Horticultural Council's comment
asking that certain tolerances in 40 CFR 180.315, including those on
broccoli and cabbage, not be revoked. At that time, the Agency
responded that it would not revoke the tolerances on broccoli and
cabbage in 40 CFR 180.315, but would follow-up to see that data
requirements were met should an interested party support those
tolerances for import purposes. However, in the interim period, no
interested party has declared an interest and committed in writing to
do the required data to support the broccoli and cabbage tolerances for
import purposes.
However, because there are registered acephate uses on Brussels
sprouts, cauliflower, celery, and head lettuce, EPA is proposing to
recodify the tolerances for Brussels sprouts, cauliflower, and lettuce
from 40 CFR 180.315(a) into (a)(2) and celery from (b) into (a)(2).
Also, in order to reflect active registered use of acephate on head
lettuce, EPA is proposing in 40 CFR 180.315(a)(2) to revise ``lettuce''
to ``lettuce, head.'' In addition, because there is an existing
tolerance for acephate use on cauliflower, which has been reassessed in
the acephate RED at the same level, such that residues from metabolism
to methamidophos are expected to be no greater than 0.5 parts per
million (ppm), EPA is proposing to decrease the tolerance on
cauliflower in 40 CFR 180.315(a)(2) from 1.0 to to 0.5 ppm. Also, this
proposed level will harmonize with the Codex MRL of 0.5 mg/kg on
cauliflower.
At the time of the completion of the methamidophos IRED, a
registrant submitted an import tolerance petition for peppers,
strawberries, and squash. This petition has not been reviewed. Because
there is an existing tolerance for acephate use on peppers, which in
the acephate RED has been reassessed at the same level, such that
residues from metabolism to methamidophos are expected to be no greater
than 1.0 ppm, EPA is proposing to recodify the tolerance on pepper from
40 CFR 180.315(a) to (a)(2) at 1.0 ppm. Also, this proposed level will
harmonize with the Codex MRL of 1.0 mg/kg on sweet peppers.
Because there are registered methamidophos uses on potato, EPA is
proposing to recodify the tolerance at 0.1 ppm on potato from 40 CFR
180.315(a) into (a)(1). There is a Codex MRL of 0.05 ppm on potato, but
harmonization is not possible because of differences in agricultural
practices.
Based on available data that showed methamidophos residues as high
as 0.191 ppm on cottonseed, EPA determined that the tolerance on
cottonseed should be increased from 0.1 to 0.2 ppm. Therefore, the
Agency is proposing to recodify the tolerance on cotton, undelinted
seed from 40 CFR 180.315(a) to (a)(1) and increase the tolerance to 0.2
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. Also, this proposed level
will harmonize with the Codex MRL of 0.2 mg/kg on cottonseed.
Based on available data that showed methamidophos residues as high
as 8.03 ppm on cotton gin byproducts, EPA determined that a tolerance
on cotton gin byproducts should be established at 10.0 ppm. Therefore,
the Agency is proposing to establish a tolerance on cotton, gin
byproducts in 40 CFR 180.315(a)(1) at 10.0 ppm.
Based on available data that showed methamidophos residues as high
as 1.4 ppm on tomatoes, EPA determined that the tolerance on tomato
should be increased from 1.0 to 2.0 ppm. Because there are only active
FIFRA section 24(c) registrations for use of methamidophos on tomatoes
and no active registrations for use of acephate on tomatoes, the Agency
has determined that the tolerance should be recodified as a regional
tolerance. Therefore, the Agency is proposing to recodify 40 CFR
180.315(b) as (c) and the tolerance on tomato from 40 CFR 180.315(a) to
(c), and increase the tolerance to 2.0 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 revise the tolerance
expression in newly recodified 40 CFR 180.315(c), as follows:
Tolerances with regional registration, as defined in 40 CFR
180.1(m), are established for residues of methamidophos (O,S-dimethyl
phosphoramidothioate) in or on the following food commodities as a
result of the application of the insecticide methamidophos.
In addition, EPA is proposing to revise 40 CFR 180.315 by adding
separate paragraphs (b) and (d), and
[[Page 28915]]
reserving those sections for tolerances with section 18 emergency
exemptions, and indirect or inadvertent residues, respectively.
Because there are existing tolerances for use of acephate on dry
and succulent beans and cranberries, which in the acephate RED have
been reassessed at the same level, such that residues from metabolism
to methamidophos are expected to be no greater than 1.0 ppm and 0.1
ppm, respectively, EPA is proposing to establish tolerances in 40 CFR
180.315(a)(2) for residues of methamidophos as a result from the
application of acephate on bean, dry, seed at 1.0 ppm, bean, succulent
at 1.0 ppm, and cranberry at 0.1 ppm.
Because there is an existing tolerance for use of acephate on mint
hay, which in the acephate RED has been reassessed to be increased from
15.0 to 27.0 ppm, such that residues from metabolism to methamidophos
are expected to be increased from no greater than 1.0 to 2.0 ppm, EPA
is proposing to establish a tolerance in 40 CFR 180.315(a)(2) for
residues of methamidophos as a result from the application of acephate
on mint, hay at 2.0 ppm and revise it to ``peppermint, tops'' and
``spearmint, tops.''
2. Oxydemeton-methyl. Currently, the tolerances in 40 CFR 180.330
are expressed for residues of oxydemeton-methyl and its cholinesterase-
inhibiting metabolites. Based on the Agency's determination that only
residues of oxydemeton-methyl and its metabolite oxydemeton-methyl
sulfone are of concern in plants, the tolerances in 40 CFR 180.330
should be recodified for plant commodities from 40 CFR 180.330(a) to
(a)(1) and animal commodities from 40 CFR 180.330(a) to (a)(2).
Therefore, EPA is proposing to recodify plant tolerances in 40 CFR
180.330(a)(1) and animal tolerances in 40 CFR 180.330(a)(2) and revise
the tolerance expression in 40 CFR 180.330 as follows:
(a) General. (1) Tolerances are established for the combined
residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-
ethyl) O,O-dimethyl phosphorothioate) and its metabolite oxydemeton-
methyl sulfone in or on the following food commodities.
(2) Tolerances are established for the combined residues of the
insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-ethyl) O,O-
dimethyl phosphorothioate) and its cholinesterase-inhibiting
metabolites in or on the following food commodities.
Because certain registered uses have product labels which prohibit
harvest within one year of application, so that there is no reasonable
expectation of residues on food commodities, the Agency considers them
to be nonfood uses of oxydemeton-methyl. As a result, the tolerances in
40 CFR 180.330 for these nonfood uses are no longer needed and should
be revoked for apple, apricot, grape, and plum, prune, fresh.
Therefore, the Agency is proposing to revoke the tolerances in 40 CFR
180.330(a) on apple, grape, and plum, prune, fresh and in 40 CFR
180.330(c) on apricot.
Because bean, lima, forage; clover, seed screenings; and sorghum
milled fractions (except flour) are no longer considered by the Agency
to be significant animal feed items, their tolerances in 40 CFR 180.330
are no longer needed and should be revoked. Therefore, the Agency is
proposing to revoke the tolerances in 40 CFR 180.330 on bean, lima,
forage; clover, seed screenings; and sorghum, milled fractions (except
flour).
In 1994, the technical registrant for oxydemeton-methyl (ODM)
agreed not to market ODM on snap beans, field corn, popcorn, pears, and
turnips but retained them on registrations with the possibility of
requesting to reinstate them on marketing labels after EPA's review of
needed ODM data and completion of dietary and worker risk assessments.
In a letter to the Agency dated February 4, 2004, the technical
registrant requested to amend the registrations for both a technical
and end-use registration and delete those uses. In the Federal Register
of November 4, 2005 (70 FR 67167) (FRL-7744-7), EPA published a notice
announcing the receipt of requests for amendments to delete uses in
certain pesticide registrations, including deletion for ODM use on snap
beans, field corn, popcorn, pears, and turnips concerning registrations
for one technical and one end use product. That notice had an effective
date of December 5, 2005 and allowed the registrant to sell or
distribute product under the previously approved labelling for a period
of 18 months after approval of the revision. There have been no end use
marketing labels for ODM use on these commodities since September 18,
1995. However, there has been one active technical registration with
these uses from 1995 through the December 5, 2005 effective date that
amended its label. Nevertheless, despite the allowance by EPA that
existing stocks for the technical and end use registrations could be
sold or distributed by the registrant for 18 months, the Agency
believes that no end users have used ODM on snap beans, field corn,
popcorn, pears, and turnip commodities since 1995. Therefore, EPA
believes that existing stocks of end use product was exhausted years
ago and that such ODM treated-snap beans, field corn, popcorn, pears,
and turnip commodities passed through channels of trade long ago and
that sufficient time has passed. Consequently, EPA is proposing to
revoke the tolerances in 40 CFR 180.330 on bean, snap, succulent; bean,
snap, forage; corn, grain; pear; turnip; and turnip, greens; all on the
date of publication of the final rule.
Based on available data that showed combined oxydemeton-methyl
residues of concern as high as 0.9 ppm in or on corn forage, EPA
determined that the tolerance on corn forage should be decreased from
3.0 to 1.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.330 to
decrease the tolerance on corn, forage to 1.0 ppm and revise it to
corn, sweet, forage. No tolerance on field corn forage is needed.
Based on available data that showed combined oxydemeton-methyl
residues of concern as high as 9.84 ppm in or on clover hay grown for
seed, EPA determined that the tolerance on clover hay grown for seed
should be decreased from 11.0 to 10.0 ppm. Therefore, the Agency is
proposing in 40 CFR 180.330 to decrease the tolerance on clover, hay,
grown for seed to 10.0 ppm and revise it to clover, hay.
Based on available data that showed combined oxydemeton-methyl
residues of concern as high as 0.15 ppm in or on lima beans, 0.2 ppm in
or on melons, less than 0.1 ppm in or on pumpkins, and less than 0.05
ppm in or on walnuts, EPA determined that the tolerances on lima beans,
cottonseed, melons, pumpkins, and walnuts should be decreased from 0.5
to 0.2 ppm, 0.1 to 0.02 ppm, 0.3 to 0.2 ppm, 0.3 to 0.2 ppm, and 0.3 to
0.05 ppm, respectively. Therefore, the Agency is proposing in 40 CFR
180.330 to decrease the tolerances on bean, lima to 0.2 ppm, cotton,
undelinted seed to 0.02 ppm, melon to 0.2 ppm, pumpkin to 0.2 ppm, and
walnut to 0.05 ppm.
Based on available data that showed combined oxydemeton-methyl
residues of concern as high as 1.22 ppm in or on cabbage, EPA
determined that the tolerance on cabbage should be increased from 1.0
to 2.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.330 to
increase the tolerance on cabbage to 2.0 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, because there is one active FIFRA
section 24(c) registration for foliar use of oxydemeton-methyl on
broccoli raab, EPA determined that data could be translated from
cabbage and broccoli to broccoli raab, and therefore a tolerance
[[Page 28916]]
should be established on broccoli raab at 2.0 ppm. Therefore, EPA is
proposing to establish a regional tolerance on broccoli raab in 40 CFR
180.330(c) at 2.0 ppm and revise the tolerance expression in 40 CFR
180.330(c) as follows:
(c) Tolerances with regional registrations, as defined in 40 CFR
180.1(m), are established for the combined residues of the
insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-ethyl) O,O-
dimethyl phosphorothioate) and its metabolite oxydemeton-methyl
sulfone in or on the following food commodities.
Based on a poultry metabolism study at the 6x feeding level that
showed no residues of toxicological concern in poultry commodities and
an earlier poultry metabolism study that showed residues were present
in eggs and tissues, EPA determined that egg and poultry tolerances
should be established at the limit of quantitation (LOQ) of 0.01 ppm.
Therefore, the Agency is proposing to establish tolerances in 40 CFR
180.330(a)(2) on egg; poultry, fat; poultry, meat; and poultry, meat
byproducts at 0.01 ppm.
Also, EPA is proposing to revise commodity terminology in 40 CFR
180.330 to conform to current Agency practice as follows: ``alfalfa,
green'' to ``alfalfa, forage;'' ``alfalfa, hay, grown for seed'' to
``alfalfa, hay;'' ``beet, sugar'' to ``beet, sugar, roots;'' ``corn,
stover'' to ``corn, sweet, stover'' (no tolerances are needed on field
corn stover or popcorn stover) ``mint, hay'' to ``peppermint, tops''
and ``spearmint, tops;'' ``onion, dry bulb'' to ``onion, bulb;''
``orange, sweet'' to ``orange;'' ``sorghum, forage'' to ``sorghum,
forage, forage'' and ``sorghum, grain, forage;'' ``sorghum, grain'' to
``sorghum, grain, grain.''
There are no Codex MRLs for oxydemeton-methyl.
3. Profenofos. Currently, the tolerances in 40 CFR 180.404(a) are
expressed for residues of profenofos and its metabolites converted to
4-bromo-2-chlorophenyl and calculated as profenofos. Based on the
Agency's determination that only residues of profenofos per se are of
toxicological concern, the tolerance expression in 40 CFR 180.404
should be revised to reflect that profenofos per se is the only
regulated residue. Therefore, EPA is proposing to revise the tolerance
expression in 40 CFR 180.404(a) as follows:
(a) General. Tolerances are established for residues of the
insecticide profenofos (O-(4-bromo-2-chlorophenyl)-O-ethyl-S-propyl
phosphorothioate) in or on the following food commodities.
Based on available data that showed profenofos residues were as
high as 1.1 ppm on cottonseed, EPA determined that the tolerance should
be decreased from 3.0 to 2.0 ppm. Therefore, the Agency is proposing to
decrease the tolerance in 40 CFR 180.404 on cotton, undelinted seed to
2.0 ppm. Also, this proposed level will harmonize with the Codex MRL of
2 mg/kg on cottonseed.
Based on available data that showed profenofos residues as high as
53 ppm, EPA determined that a tolerance of 55.0 ppm should be
established for cotton gin byproducts. Therefore, the Agency is
proposing to establish a tolerance in 40 CFR 180.404 for the residues
of profenofos on cotton, gin byproducts at 55.0 ppm.
4. Trichlorfon. There are no active registrations for the use of
the insecticide trichlorfon for cattle commodities in the United
States. However, trichlorfon is used as a dermal pour-on application
for cattle for import purposes. Based on cattle metabolism data from
dermal application of trichlorfon which showed residues of trichlorfon
as high as 0.2 ppm in muscle and less than 0.5 ppm in fat, EPA
determined that the tolerances on cattle meat and cattle fat should be
increased from 0.1 ppm to 0.2 ppm and 0.1 to 0.5 ppm, respectively.
Therefore, EPA is proposing in 40 CFR 180.198 to increase the
tolerances on cattle, meat to 0.2 ppm and cattle, fat to 0.5 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. Dichlorvos is a degradate
of trichlorfon. However, as stated in the 2006 Dichlorvos RED, non-
detectable dichlorvos residues in livestock commodities are expected as
a result of trichlorfon use, and dichlorvos was not a significant
metabolite in the trichlorfon dermal metabolism data. Therefore,
dietary (food) exposure to dichlorvos residues resulting from use of
trichlorfon is considered by the Agency to be negligible.
Also, in 40 CFR 180.198, 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. In addition, in order to conform to current Agency practice,
EPA is proposing to revise 40 CFR 180.198 and establish subparts (a)
through (d), recodify general tolerances under 40 CFR 180.198(a) and
reserve sections (b) for tolerances with section 18 emergency
exemptions, (c) for regional registrations, and (d) for indirect or
inadvertent residues.
There are no Codex MRLs for trichlorfon.
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 the 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 the FFDCA, 21 U.S.C. 342(a).
Such food may not be distributed in interstate commerce (21 U.S.C.
331(a)). For a food-use 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 in follow-up to the
tolerance recommendations made during the reregistration and tolerance
reassessment processes (including follow-up on canceled or additional
uses of pesticides). The safety finding determination under section 408
of the FFDCA standard 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.
EPA has issued post-FQPA REDs for methamidophos, oxydemeton-methyl,
and profenofos, and a TRED for trichlorfon, whose RED was completed
prior to FQPA. REDs and TREDs contain the Agency's evaluation of the
data base 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,
[[Page 28917]]
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 the 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 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.
EPA has developed guidance concerning submissions for import
tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3). This
guidance will be made available to interested persons. Electronic
copies are available on the internet at https://www.epa.gov/. On the
Home Page select ``Laws, Regulations, and Dockets,'' then select
Regulations and Proposed Rules and then look up the entry for this
document under ``Federal Register--Environmental Documents.'' You can
also go directly to the ``Federal Register'' listings at https://
www.epa.gov/fedrgstr/.
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 rule and has concluded that
there is no reasonable expectation of finite pesticide residues of
concern in or on those commodities.
C. When do These Actions Become Effective?
EPA is proposing that the actions herein become effective on the
date of publication of the final rule in the Federal Register, because
their associated uses have been canceled for several years. 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 had sufficient
time for passage 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 channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(1)(5), as
established by FQPA. Under this section, 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 the 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
[[Page 28918]]
international Maximum Residue Limits (MRLs) established by the Codex
Alimentarius Commission, as required by section 408(b)(4) of the FFDCA.
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 standards-setting
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, section 408(b)(4) of FFDCA 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 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 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, 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),
respectively, and were provided to the Chief Counsel for Advocacy of
the Small Business Administration. Taking into account this analysis,
and available information concerning the pesticides listed in this
proposed rule, the Agency hereby certifies that this proposed action
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 pesticide 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 the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any [ld]quo;tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable 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.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 16, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
[[Page 28919]]
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
Sec. 180.3 [Amended]
2. Section 180.3 is amended by removing paragraph (d)(8) and
redesignationg paragraphs (d)(9) through (d)(14) as paragraphs (d)(8)
through (d)(13).
3. Section 180.198 is revised to read as follows:
Sec. 180.198 Trichlorfon; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide trichlorfon (dimethyl (2,2,2-trichloro-1-hydroxyethyl)
phosphonate) in or on the following food commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat \1\...................................... 0.5
Cattle, meat \1\..................................... 0.2
Cattle, meat byproducts \1\.......................... 0.1
------------------------------------------------------------------------
\1\There are no U.S. registrations for cattle commodities as of June 24,
1999.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
4. Section 180.315 is revised to read as follows:
Sec. 180.315 Methamidophos; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
methamidophos (O,S-dimethyl phosphoramidothioate) in or on the
following food commodities as a result of the application of the
insecticide methamidophos.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cotton, gin byproducts............................... 10.0
Cotton, undelinted seed.............................. 0.2
Potato............................................... 0.1
------------------------------------------------------------------------
(2) Tolerances are established for residues of methamidophos (O,S-
dimethyl phosphoramidothioate) in or on the following food commodities
as a result of the application of the insecticide acephate.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Bean, dry, seed...................................... 1.0
Bean, succulent...................................... 1.0
Brussels sprouts..................................... 1.0
Cauliflower.......................................... 0.5
Celery............................................... 1.0
Cranberry............................................ 0.1
Lettuce, head........................................ 1.0
Pepper............................................... 1.0
Peppermint, tops..................................... 2.0
Spearmint, tops...................................... 2.0
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. Tolerances with
regional registration, as defined in 180.1(m), are established for
residues of methamidophos (O,S-dimethyl phosphoramidothioate) in or on
the following food commodities as a result of the application of the
insecticide methamidophos.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Tomato 2.0
------------------------------------------------------------------------
(d) Indirect or inadvertent residues. [Reserved]
5. Section 180.330 is revised to read as follows:
Sec. 180.330 S-(2-(Ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate;
tolerances for residues.
(a) General. (1) Tolerances are established for the combined
residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-
ethyl) O,O-dimethyl phosphorothioate) and its metabolite oxydemeton-
methyl sulfone in or on the following food commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Alfalfa, forage...................................... 5.0
Alfalfa, hay......................................... 11.0
Bean, lima........................................... 0.2
Beet, sugar, roots................................... 0.3
Beet, sugar, tops.................................... 0.5
Broccoli............................................. 1.0
Brussels sprouts..................................... 1.0
Cabbage.............................................. 2.0
Cauliflower.......................................... 1.0
Clover, forage....................................... 5.0
Clover, hay.......................................... 10.0
Corn, sweet, forage.................................. 1.0
Corn, sweet, kernel plus cob with husks removed...... 0.5
Corn, sweet, stover.................................. 3.0
Cotton, undelinted seed.............................. 0.02
Cucumber............................................. 1.0
Eggplant............................................. 1.0
Filbert.............................................. 0.05
Grapefruit........................................... 1.0
Lemon................................................ 1.0
Lettuce, head........................................ 2.0
Melon................................................ 0.2
Onion, bulb.......................................... 0.05
Orange............................................... 1.0
Pepper............................................... 0.75
Peppermint, tops..................................... 12.5
Pumpkin.............................................. 0.2
Safflower, seed...................................... 1.0
Sorghum, forage, forage.............................. 2.0
Sorghum, grain, forage............................... 2.0
Sorghum, grain, grain................................ 0.75
Spearmint, tops...................................... 12.5
Squash, summer....................................... 1.0
Squash, winter....................................... 0.3
Strawberry........................................... 2.0
Walnut............................................... 0.05
------------------------------------------------------------------------
(2) Tolerances are established for the combined residues of the
insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-ethyl) O,O-dimethyl
phosphorothioate) and its cholinesterase-inhibiting metabolites in or
on the following food commodities.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat.......................................... 0.01
Cattle, meat......................................... 0.01
Cattle, meat byproducts.............................. 0.01
Egg.................................................. 0.01
Goat, fat............................................ 0.01
Goat, meat........................................... 0.01
Goat, meat byproducts................................ 0.01
Hog, fat............................................. 0.01
Hog, meat............................................ 0.01
Hog, meat byproducts................................. 0.01
Horse, fat........................................... 0.01
Horse, meat.......................................... 0.01
Horse, meat byproducts............................... 0.01
Milk................................................. 0.01
Poultry, fat......................................... 0.01
Poultry, meat........................................ 0.01
Poultry, meat byproducts............................. 0.01
Sheep, fat........................................... 0.01
Sheep, meat.......................................... 0.01
Sheep, meat byproducts............................... 0.01
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. Tolerances with
regional registrations, as defined in 180.1(m), are established for the
combined residues of the insecticide oxydemeton-methyl (S-(2-
(ethylsulfinyl)-ethyl) O,O-dimethyl phosphorothioate) and its
metabolite oxydemeton-methyl sulfone in or on the following food
commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Broccoli raab........................................ 2.0
------------------------------------------------------------------------
(d) Indirect or inadvertent residues. [Reserved]
6. Section 180.404, paragraph (a) is revised to read as follows:
Sec. 180.404 Profenofos; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide profenofos (O-(4-bromo-2-chlorophenyl)-O-ethyl-S-propyl
phosphorothioate) in or on the following food commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat.......................................... 0.05
[[Page 28920]]
Cattle, meat......................................... 0.05
Cattle, meat byproducts.............................. 0.05
Cotton, gin byproducts............................... 55.0
Cotton, undelinted seed.............................. 2.0
Goat, fat............................................ 0.05
Goat, meat........................................... 0.05
Goat, meat byproducts................................ 0.05
Horse, fat........................................... 0.05
Horse, meat.......................................... 0.05
Horse, meat byproducts............................... 0.05
Milk................................................. 0.01
Sheep, fat........................................... 0.05
Sheep, meat.......................................... 0.05
Sheep, meat byproducts............................... 0.05
------------------------------------------------------------------------
* * * * *
FR Doc. 07-2561 Filed 5-22-07; 8:45 am
BILLING CODE 6560-50-S