FR Doc E8-2094

[Federal Register: February 6, 2008 (Volume 73, Number 25)]
[Proposed Rules]
[Page 6867-6879]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06fe08-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0674; FRL-8345-2]

2,4-D, Bensulide, DCPA, Desmedipham, Dimethoate, Fenamiphos,
Phorate, Sethoxydim, Terbufos, and Tetrachlorvinphos; Proposed
Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke certain tolerances for the
herbicide sethoxydim and the insecticides dimethoate, fenamiphos,
terbufos, and tetrachlorvinphos. Also, EPA is proposing to modify
certain tolerances for the herbicides 2,4-D, DCPA, desmedipham, and
sethoxydim and the insecticides dimethoate, fenamiphos, phorate, and
tetrachlorvinphos. In addition, EPA is proposing to establish new
tolerances for the herbicides bensulide and sethoxydim. 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 April 7, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0674 by one of the following methods:
Federal eRulemaking Portal: http://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-
2007-0674. EPA's policy is that all comments

[[Page 6868]]

received will be included in the docket without change and may be made
available on-line at http://www.regulations.gov, including any personal

information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
regulations.gov or e-mail. The regulations.gov website is an
``anonymous access'' system, which 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
http://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
website 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 http://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: Jane Smith, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0048; e-mail
address: smith.jane-scott@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II.A. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.

C. What Can I do if I Wish the Agency to Maintain a Tolerance that the
Agency Proposes to Revoke?

This proposed rule provides a comment period of 60 days for any
person to state an interest in retaining a tolerance proposed for
revocation. If EPA receives a comment within the 60-day period to that
effect, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
FFDCA section 408(f), if needed. The order would specify data needed
and the timeframes for its submission, and would require that within 90
days some person or persons notify EPA that they will submit the data.
If the data are not submitted as required in the order, EPA will take
appropriate action under FFDCA.
EPA issues a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposal, you may also submit an objection
at the time of the final rule. If you fail to file an objection to the
final rule within the time period specified, you will have waived the
right to raise any issues resolved in the final rule. After the
specified time, issues resolved in the

[[Page 6869]]

final rule cannot be raised again in any subsequent proceedings.

II. Background

A. What Action is the Agency Taking?

EPA is proposing to revoke, modify, and establish specific
tolerances for residues of the herbicides 2,4-D, bensulide, DCPA,
desmedipham, and sethoxydim and the insecticides fenamiphos, phorate,
dimethoate, terbufos, and tetrachlorvinphos 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 FFDCA. The safety finding determination of ``reasonable
certainty of no harm'' is discussed in detail in each Reregistration
Eligibility Decision (RED) and Report of the Food Quality Protection
Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision
(TRED) for the active ingredient. REDs and TREDs recommend the
implementation of certain tolerance actions, including modifications to
reflect current use patterns, meet safety findings, and change
commodity names and groupings in accordance with new EPA policy.
Printed copies of many REDs and TREDs may be obtained from EPA's
National Service Center for Environmental Publications (EPA/NSCEP),
P.O. Box 42419, Cincinnati, OH 45242-2419; telephone number: 1-800-490-
9198; fax number: 1-513-489-8695; Internet at http://www.epa.gov/ncepihom
and from the National Technical Information Service (NTIS),

5285 Port Royal Rd., Springfield, VA 22161; telephone number: 1-800-
553-6847 or (703) 605-6000; Internet at http://www.ntis.gov. Electronic

copies of REDs, TREDs, and IREDs are available on the Internet at
http://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 electronically. Electronic copies are available through EPA's
electronic public docket and comment system, regulations.gov at http://www.regulations.gov.
You may search for docket ID number EPA-HQ-OPP-

2007-0674 and/or 2,4-D (EPA-HQ-OPP-2004-0167), Bensulide (EPA-HQ-OPP-
2007-0674 and EPA-HQ-OPP-2007-0151), DCPA (EPA-HQ-OPP-2007-0097),
Desmedipham (EPA-HQ-OPP-2004-0261), Dimethoate (EPA-HQ-OPP-2005-0084),
Fenamiphos (EPA-HQ-OPP-2007-0674 and EPA-HQ-OPP-2007-0151), Phorate
(EPA-HQ-OPP-2007-0674 and EPA-HQ-OPP-2007-0151), Sethoxydim (EPA-HQ-
OPP-2005-0323), Terbufos (EPA-HQ-OPP-2007-0674 and EPA-HQ-OPP-2007-
0151), and Tetrachlorvinphos (EPA-HQ-OPP-2007-0674 and EPA-HQ-OPP-2007-
0151) then click on that docket ID number to view its contents.
EPA has determined that the aggregate exposures and risks are not
of concern for the above-mentioned pesticide active ingredients based
upon the data identified in the RED or TRED which lists the submitted
studies that the Agency found acceptable.
EPA has found that the tolerances that are proposed in this
document to be modified, are safe; i.e., that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residues, in accordance
with FFDCA section 408(b)(2)(C). (Note that changes to tolerance
nomenclature do not constitute modifications of tolerances). These
findings are discussed in detail in each RED or TRED. The references
are available for inspection as described in this document under
SUPPLEMENTARY INFORMATION.
In addition, EPA is proposing to revoke certain specific tolerances
because either they are no longer needed or are associated with food
uses that are no longer registered under FIFRA. Those instances where
registrations were canceled were because the registrant failed to pay
the required maintenance fee and/or the registrant voluntarily
requested cancellation of one or more registered uses of the pesticide.
It is EPA's general practice to propose revocation of those tolerances
for residues of pesticide active ingredients on crop uses for which
there are no active registrations under FIFRA, unless any person in
comments on the proposal indicates a need for the tolerance to cover
residues in or on imported commodities or legally treated domestic
commodities.
1. 2,4-D. In the Federal Register notices published on June 6, 2007
(72 FR 31221) (FRL-8122-7) and September 12, 2007 (72 FR 52013) (FRL-
8142-2), the Agency determined in error that the tolerances in/on
grapes, stone fruits, and pome fruits should be decreased to 0.1 ppm
rather than 0.05 ppm. In that same proposal, the tolerance for
strawberries was increased to 0.1 ppm in error, when, in fact, it
should have remained unchanged at 0.05 ppm. Therefore, EPA proposes
correcting the tolerances in 40 CFR 180.142(a) for the combined 2,4-D
residues of concern in/on grape from 0.1 to 0.05 ppm; fruit, stone,
group 12 from 0.1 to 0.05 ppm; fruit, pome group 11 from 0.1 to 0.05
ppm, and strawberry from 0.1 to 0.05 ppm.
2. Bensulide. In order to account for the instability of bensulide
in/on cucurbits and leafy vegetables as evidenced in a non-concurrent
storage stability study, the Agency has determined the tolerances
should be increased from 0.1 to 0.15 ppm in/on vegetable, cucurbit
group 9 and vegetable, leafy, except brassica group 4. The Agency is
also revising commodity terminology to conform to current practice
including removing the negligible residue designation (N)

[[Page 6870]]

associated with the tolerances. Therefore, EPA proposes increasing and
revising the tolerances in 40 CFR 180.241(a) for the combined bensulide
residues of concern in/on cucurbits at 0.10 (N) ppm to vegetable,
cucurbit group 9 at 0.15; and vegetable, leafy at 0.1 (N) ppm to
vegetable, leafy, except brassica group 4 at 0.15 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.
Because the use of bensulide is limited to Texas, the Agency has
determined that the carrot tolerance should be a regional tolerance.
Therefore, EPA proposes transferring the carrot, root at 0.1 ppm
tolerance in 40 CFR 180.241(a) to 40 CFR 180.241(c).
Based on available field trial data that indicate bensulide
residues of concern are less than 0.15 ppm in/on the representative
commodities (broccoli, cabbage, and Brussels sprouts) of the vegetable,
brassica, leafy group 5, the Agency determined that the tolerance
should be established for vegetable, brassica, leafy group 5 at 0.15
ppm. Therefore, EPA proposes establishing a tolerance in 40 CFR
180.241(a) for combined bensulide residues of concern in/on vegetable,
brassica, leafy group 5 at 0.15 ppm.
The Agency is revising commodity terminology to conform to current
practice. Therefore, EPA proposes revising the tolerances in 40 CFR
180.241 from onion, dry bulb to onion, bulb; and vegetable, fruiting to
vegetable, fruiting, group 8.
Currently, there are no Codex MRLs (maximum residue levels) in
place for bensulide.
3. DCPA. In the Federal Register proposal and final rule published
on June 6, 2007 (72 FR 31221) (FRL-8122-7), and September 12, 2007 (72
FR 52013) (FRL-8142-2), the permanent tolerance on vegetable, brassica,
leafy, group 5 at 5 ppm was transferred to inadvertent tolerance
because there were no uses on brassica vegetables. Since then, it has
been determined that there are direct uses of DCPA on brassica
vegetables and a permanent tolerance in/on vegetable, brassica, leafy,
group 5 at 5 ppm is appropriate. Therefore, EPA proposes transferring
the tolerance vegetable, brassica, leafy, group 5 at 5 ppm in 40 CFR
180.185(d) to 40 CFR 180.185(a) for the combined residues of the
herbicide DCPA and its metabolites MTP and TCP (calculated as DCPA).
4. Desmedipham. Based on field trial data received subsequent to
the TRED that indicate residues of desmedipham as high as 0.05 ppm in/
on sugar beet roots and an average of 1.38 ppm (standard deviation 2.88
ppm) in/on sugar beet tops, the Agency determined that the tolerance
should be decreased from 0.2 ppm to 0.1 ppm in/on sugar beet roots and
increased from 0.2 ppm to 5.0 ppm in/on sugar beet tops. Therefore, EPA
proposes revising the tolerance on sugar beet (roots and tops) from 0.2
ppm to sugar, beet, roots at 0.1 ppm and sugar, beet, tops at 5.0 ppm
in 40 CFR 180.353(a) for residues of the herbicide desmedipham (ethyl-
m-hydroxycarbanilate carbanilate). 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.
Currently, there are no Codex MRLs in place for desmedipham.
5. Dimethoate. The uses on apples, cabbage, collards, head lettuce,
spinach, and grapes were canceled due to revisions of the human health
risk assessment for tolerance reassessment as published in Federal
Register Notices dated Sept 10, 2003 (69 FR 53371) (FRL-7321-2),
January 28, 2004 (69 FR 4135) (FRL-7340-1), and May 12, 2004 (69 FR
26384) (FRL-7354-3). Although the use on head lettuce has been
canceled, the use on leaf lettuce remains. There are no active
registrations with the use on blueberries; however, the blueberry
tolerance is for the purpose of imports and for this reason will not be
revoked. Lentils are covered by the existing pea, dry tolerance in
accordance with 40 CFR 180.1(g). Therefore, EPA proposes revoking the
tolerances in 40 CFR 180.204(a) for the combined dimethoate residues of
concern in/on apple at 2 ppm; cabbage at 2 ppm; collards at 2 ppm;
grape at 1 ppm; lentil, seed at 2 ppm; and spinach at 2 ppm; and revise
lettuce to lettuce, leaf.
Based on field trial residue data serving as the basis of the
tolerance on potatoes at 0.2 ppm and translating those data to turnip
roots, the Agency has determined that the tolerance in/on turnip roots
should be decreased to 0.2 ppm. Therefore, EPA proposes decreasing the
tolerance in 40 CFR 180.204(a) for the combined dimethoate residues of
concern in/on turnip, roots from 2 ppm to 0.2 ppm.
Based on available field trial data that indicate dimethoate
residues of concern less than 0.1 ppm in/on sorghum grain and forage,
the Agency determined that the tolerance should be decreased to 0.1 ppm
in/on sorghum, grain, forage and a tolerance should be established for
sorghum, grain, stover at 0.1 ppm. EPA is also revising the commodity
terminology to conform to current Agency practice. Therefore, EPA
proposes decreasing and revising the tolerance in 40 CFR 180.204(a) for
the combined dimethoate residues of concern from sorghum, forage at 0.2
ppm to sorghum, grain, forage at 0.1 ppm and establishing a tolerance
on sorghum, grain, stover at 0.1 ppm.
EPA is revising the commodity terminology to conform to current
Agency practice. Also, when the tolerance reassessment was conducted
for reregistration on dimethoate, the tolerance on ``wheat, green
fodder'' existed. The correct terminology for ``wheat, green fodder''
is ``wheat, hay'' and ``wheat, forage.'' Recently, 40 CFR 180.204 has
been revised to align commodity terminology to current standards. At
that time, the ``wheat, green fodder'' tolerance was revised to
``wheat, hay'' and the tolerance for ``wheat, forage'' was
inadvertently omitted; therefore, the wheat, forage tolerance should be
established. Lastly, the Agency is correcting the reference to 180.1(n)
to 180.1(m) in 40 CFR 180.204(c). Therefore, EPA proposes revising the
tolerances in 40 CFR 180.204(a) for the combined dimethoate residues of
concern in/on alfalfa to alfalfa, forage and alfalfa, hay; from corn,
forage to corn, field, forage and corn, sweet, forage; corn, grain to
corn, field, grain and corn, pop, grain; corn, stover to corn, field,
stover and corn, pop, stover; sorghum, grain to sorghum, grain, grain;
soybean to soybean, seed; and turnip, greens to turnip, tops; proposes
establishing a tolerance in/on wheat, forage at 2.0 ppm and proposes
revising tolerances in 40 CFR 180.204(c) from cherry to cherry, sweet
and cherry, tart and revising the reference of 180.1(n) to 180.1(m).
The Codex Alimentarius Commission has established separate maximum
residue limits (MRLs) for dimethoate per se and omethoate per se in/on
various commodities resulting from application of the insecticides
dimethoate, formothion, and omethoate. By contrast, the U.S. tolerance
expression is in terms of the combined residues of dimethoate and
omethoate, as a metabolite. Formothion and omethoate are not currently
registered for use in the U.S. Therefore, the Codex MRLs and U.S.
tolerances are not harmonized with respect to MRL/tolerance expression.
6. Fenamiphos. Based on the available field trial data that
indicate fenamiphos residues of concern are up to 1.0 ppm in/on
peanuts, the Agency determined that the tolerance should be increased
to 1.0 ppm. Therefore, EPA proposes increasing the tolerance in 40 CFR

[[Page 6871]]

180.349(a)(1) for fenamiphos residues of concern in/on peanut from 0.02
ppm to 1.0 ppm. The Agency determined that the increased tolerance is
safe; i.e., there is a reasonable certainty that no harm will result
form aggregate exposure to the pesticide chemical residue.
Based on the available field trial data that indicate fenamiphos
residues of concern are less than 0.05 ppm in/on eggplant and Brussels
sprouts, the Agency determined that the tolerances should be decreased
to 0.05 ppm. The Agency is also decreasing the Brussels sprouts
tolerance to harmonize with Codex. Therefore, EPA proposes decreasing
the tolerance in 40 CFR 180.349(a)(1) for fenamiphos residues of
concern in/on eggplant from 0.10 ppm to 0.05 ppm and Brussels sprouts
from 0.10 ppm to 0.05 ppm.
Pineapple bran is no longer regulated as a commodity in accordance
with Table 1.--Raw Agricultural and Processed Commodities and
Feedstuffs Derived from Crops which is found in Residue Chemistry Test
Guidelines OPPTS 860.1000 dated August 1996, available at http://www.epa.gov/opptsfrs/publications/OPPTS
Harmonized/860 Residue

Chemistry Test Guidelines/Series; consequently, the Agency has
determined that a pineapple bran tolerance is no longer needed. There
are no active registrations for the use of fenamiphos on cotton,
consequently the Agency has determined the cotton undelinted seed
tolerance should be revoked. Therefore, EPA proposes removing the
tolerance in/on pineapple, bran and revoking the tolerance in/on
cotton, undelinted seed in 40 CFR 180.349(a)(1) for fenamiphos residues
of concern.
There are currently individual tolerances for grapefruit, lemon,
lime, orange, and tangerine each at 0.60 ppm. Because there are
established tolerances for the representative commodities for the
fruit, citrus, group 10 and the use patterns on these commodities are
the same, the Agency determined that the individual tolerances should
be replaced with the fruit, citrus, group 10 tolerance. Further, in
order to harmonize with the Codex MRLs, the Agency has determined the
tolerances associated with these commodities should be decreased from
0.60 to 0.50 ppm. Therefore, EPA proposes removing the tolerances in 40
CFR 180.349(a)(1) for fenamiphos residues of concern in/on grapefruit;
lemon; lime; orange, sweet; and tangerine each at 0.60 ppm and
establishing a tolerance for fruit, citrus, group 10 at 0.50 ppm.
Based on revisions of the OPPTS Harmonized Test Guidelines--Series
860 Residue Chemistry Guidelines (August 1996) Table 1 available at
http://www.epa.gov/opptsfrs/publications/OPPTS Harmonized/860 Residue

Chemistry Test Guidelines/Series eliminating several animal feed items
used to estimate secondary residues in livestock commodities, the
Agency determined there is no expectation of finite residues in animal
commodities in accordance with Category 40 CFR 180.6(a)(3). Therefore,
EPA proposes revoking all of the tolerances in 40 CFR 180.349(a)(2) for
fenamiphos residues of concern in cattle, fat; cattle, meat; cattle,
meat byproducts; goat, fat; goat, meat; goat, meat byproducts; hog,
fat; hog, meat; hog, meat byproducts; horse, fat; horse, meat; horse,
meat byproducts; milk; sheep, fat; sheep, meat; sheep, meat byproducts
each at 0.05 ppm; remove 40 CFR 180.349(a)(2); and designate 40 CFR
180.349(a)(1) as 40 CFR 180.349(a).
The Agency is revising commodity terminology to correspond to
current Agency practice. Therefore, EPA proposes revising tolerances in
40 CFR 180.349(a)(1) for fenamiphos residues of concern in/on grape,
raisins to grape, raisin and cherry to cherry, sweet and cherry, tart.
In accordance with section 6(f)(1) of FIFRA, the Agency issued a
cancellation order published on December 10, 2003 (68 FR 68901) (FRL-
7332-5). The order reflects the voluntary cancellations submitted by
Bayer CropScience for product registrations containing fenamiphos
effective May 31, 2007. The order requires the registrant to cease
sale/distribution of products (by persons other that Bayer CropScience)
containing fenamiphos by May 31, 2008. Bayer CropScience anticipates
that commodities treated with fenamiphos may continue to be imported
into the U.S. after the final effective dates and therefore supports
import tolerances for banana; fruit, citrus, group 10; garlic; grape;
and pineapple. In order to permit the use of existing stocks of
products to clear the channels of trade and for tolerances to cover
subsequent fenamiphos residues of concern on commodities, the Agency
determined the tolerances should expire on December 31, 2009 except for
those tolerances for import commodities (banana; fruit, citrus, group
10; citrus, dried pulp; citrus, oil; garlic; grape; and pineapple). The
tolerances for banana; fruit, citrus, group 10; garlic; grape; and
pineapple will not have a U.S. registration as of December 31, 2009,
and will be designated as such by a footnote. Therefore, EPA proposes
establishing an expiration/revocation date of December 31, 2009, on
tolerances in 40 CFR 180.349 for fenamiphos residues of concern in/on
apple; Brussels sprouts; cabbage; cherry, sweet; cherry, tart;
eggplant; okra; peach; peanut; raspberry; strawberry; asparagus; beet,
garden, roots; beet, garden, tops; Bok choy; kiwifruit; and pepper,
nonbell and add the footnote ``1 There are no U.S. registrations as of
December 31, 2009.''
7. Phorate. Based on available field trial data that indicate
phorate residues of concern do not exceed 0.05 ppm in or on beans,
field and sweet corn; sorghum, grain; soybean; and sugarcane, cane; the
Agency determined that the tolerance should be decreased to 0.05 ppm
in/on field and sweet corn, sorghum, grain; soybean; and sugarcane,
cane. Based on available field trial data that indicate phorate
residues of concern do not exceed 0.2 ppm in/on potato and in order to
harmonize with CODEX, the Agency has determined the tolerance should be
decreased to 0.2 ppm. Therefore, EPA proposes decreasing the tolerances
in 40 CFR 180.206(a) for phorate residues of concern in/on bean; corn,
sweet, kernel plus cob with husks removed; corn, grain; sorghum, grain;
soybean; and sugarcane, cane from 0.1 to 0.05 ppm; and potato from 0.5
to 0.2 ppm.
Based on available field trial data that indicate phorate residues
of concern are up to 2.0 ppm in or on hops, the Agency determined that
the tolerance should be increased to 2.0 ppm. Therefore, EPA is
proposing to increase the tolerances in 40 CFR 180.206(a) for phorate
residues of concern in/on hop from 0.5 to 2.0 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.
The current tolerances in 40 CFR 180.206 are expressed in terms of
phorate and its cholinesterase-inhibiting metabolites. The Agency has
determined that the tolerance expression should be revised to harmonize
with CODEX by regulating phorate, phorate sulfoxide, phorate sulfone,
phorate oxygen analog, phorate oxygen analog sulfoxide, and the phorate
oxygen analog sulfone, specifically. Therefore, EPA proposes revising
the tolerance expression in 40 CFR 180.206(a) to regulate the combined
residues of the insecticide phorate (O,O-diethyl S[(ethylthio)
methyl]phosphorodithioate), phorate sulfoxide, phorate sulfone, phorate
oxygen analog, phorate oxygen analog sulfoxide, and phorate oxygen
analog sulfone.
When the tolerance reassessment was conducted for reregistration on
phorate, the tolerance on ``wheat, green fodder''

[[Page 6872]]

existed. The correct terminology for ``wheat, green fodder'' is
``wheat, hay'' and ``wheat, forage.'' Recently, 40 CFR part 180 has
been revised to align commodity terminology to current standards. At
that time, the ``wheat, green fodder'' tolerance was revised to
``wheat, hay'' and the tolerance for ``wheat, forage'' was
inadvertently omitted. Therefore, the Agency has determined a tolerance
in/on wheat, forage at 1.5 ppm should be established. Therefore, EPA
proposes establishing a tolerance in 40 CFR 180.206(a) for the combined
residues of phorate and its cholinesterase-inhibiting metabolites in/on
wheat, forage at 1.5 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.
EPA is revising commodity terminology to conform to current Agency
practice. Therefore, EPA proposes revising the tolerances in 40 CFR
180.206(a) for the combined residues of phorate and its cholinesterase-
inhibiting metabolites from bean to bean, dry, seed and bean,
succulent; coffee, bean, green to coffee, green bean; corn, forage to
corn, field, forage and corn, sweet, forage; corn, grain to corn,
field, grain; hop to hop, dried cones; sorghum, grain to sorghum,
grain, grain; and soybean to soybean, seed; and revise the footnote to
``There are no U.S. registrations as of September 1, 1993, for the use
of phorate on the growing crop, coffee.''
The proposed tolerance actions herein for phorate, to implement the
recommendations of the phorate IRED, reflect use patterns in the U.S.
which support a different tolerance than the Codex level on beans,
beets, coffee beans, because of differences in good agricultural
practices. However, compatibility currently exists between U.S.
tolerances and Codex MRLs for cottonseed and will exist (upon
completion of this action) for phorate residues in or on potato,
sorghum grain, soybean seed, field and sweet corn/maize.
8. Sethoxydim. Based on available field trial data that indicate
residues of sethoxydim as high as 50.7 ppm in or on clover hay and 2.2
ppm in/on cranberry, the Agency determined that the tolerance should be
increased to 55 ppm in/on clover, hay and 2.5 ppm in/on cranberry.
Therefore, EPA is proposing to increase the tolerances in 40 CFR
180.412 for sethoxydim residues of concern in/on clover, hay from 50 to
55 ppm and cranberry from 2.0 to 2.5 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.
EPA is revising commodity terminology to conform to current Agency
practice. Therefore, EPA proposes revising the tolerances in 40 CFR
180.412(a) for sethoxydim residues of concern in/on bean, forage to
cowpea, forage; bean, hay to cowpea, hay; canola/rapeseed to rapeseed,
seed and canola, seed; canola/rapeseed, meal to rapeseed, meal and
canola, meal; coriander to coriander, leaves; corn, fodder to corn,
field, fodder; corn, forage to corn, field, stover; fruit, citrus to
fruit, citrus, group 10; fruit, pome to fruit, pome, group 11;
peppermint, tops (stems and leaves) to peppermint, tops; potato flakes
and potato granules to potato granules/flakes; potato waste, processed
(wet and dry) to potato waste, processed; safflower to safflower, seed;
soybean to soybean, seed; spearmint, tops (stems and leaves) to
spearmint, tops; turnip, greens to turnip, tops; and vegetable,
fruiting to vegetable, fruiting, group 8.
As part of improving sethoxydim tolerance harmonization between the
U.S. and Canada, the Agency has reexamined the residue data and
tolerance levels for bean, dry, seed at 20 ppm; lentil, seed at 30 ppm;
and pea, dry, seed 40 ppm. Using the tolerance/MRL calculator developed
under the North American Free Trade Agreement (NAFTA) and the dry peas,
lentil, and dry bean field trial data which reflect similar use
patterns, the Agency has determined the tolerances on the dry pea,
lentil seed, and dry bean commodities can be revised to the pea and
bean, dried shelled, except soybean, subgroup 6C at 25 ppm, which
covers these commodities. Therefore, EPA proposes revising the
tolerances in 40 CFR 180.412(a) for sethoxydim residues of concern from
bean, dry seed at 20 ppm; lentil, seed at 30 ppm; and pea, dry, seed at
40 ppm to pea and bean, dried shelled, except soybean, subgroup 6C at
25 ppm.
Because apple dry pomace, citrus molasses, cotton seed soapstock,
flax straw, peanut soapstock, tomato concentrated products, and tomato
dry pomace are no longer recognized as raw agricultural commodities and
are no longer considered to be significant food/feed items, the
associated tolerances are no longer needed. The tolerance for flax seed
currently covers the commodity flax, meal, therefore the flax, meal
tolerance is no longer needed. Therefore, EPA is removing the
tolerances in 40 CFR 180.412(a) in/on apple, dry pomace at 0.8 ppm;
citrus, molasses at 1.5 ppm; cotton, seed, soapstock at 15 ppm; flax,
straw at 2.0 ppm; flax, meal at 7 ppm; peanut, soapstock at 75.0 ppm;
tomato, concentrated products at 24 ppm; and tomato, dry pomace at 12.0
ppm.
Currently, there are no Codex MRLs in place for sethoxydim.
9. Terbufos. The current tolerance expression in 40 CFR 180.352
regulates the insecticide terbufos (S-[[1,1-dimethyl)thio]methyl]O,O-
diethyl phosphorodithioate) and its cholinesterase-inhibiting
metabolites. The Agency has determined that the chemical name for
terbufos should be corrected and the tolerance expression should be
more specific for the five phosphorylated (cholinesterase-inhibiting)
metabolites. Therefore, EPA proposes revising the tolerance expression
in 40 CFR 180.352(a) to regulate the combined residues of the
insecticide terbufos (phosphorodithioic acid, S-(t-butylthio)methyl
O,O-diethyl ester) and its phosphorylated (cholinesterase-inhibiting)
metabolites (phosphorothioic acid, S-(t-butylthio)methyl O,O-diethyl
ester; phosphorothioic acid, S-(t-butylsulfinyl)methyl O,O-diethyl
ester; phosphorothioic acid, S-(t-butylsulfonyl)methyl O,O-diethyl
ester; phosphorodithioic acid, S-(t-butylsulfinyl)methyl O,O-diethyl
ester; and phosphorodithioic acid, S-(t-butylsulfonyl)methyl O,O-
diethyl ester).
The Agency has determined that the coffee bean, green tolerance
should be established for import purposes. The Agency is also revising
the section to conform to current standards and configurations.
Therefore, EPA proposes transferring the tolerance in 40 CFR 180.352(b)
for the combined residues of terbufos and its cholinesterase-inhibiting
metabolites in/on coffee bean, green at 0.05 ppm to 40 CFR 180.352(a);
redesignate 40 CFR 180.352(b) as Section 18 emergency exemptions-
reserved; establish 40 CFR 180.352(c) as tolerances with regional
registrations-reserved and establish 40 CFR 180.352(d) as indirect or
inadvertent residues - reserved.
EPA is revising commodity terminology to conform to current Agency
practice and removing ``(N)''- negligible residue designation
associated with some of the tolerances because the term is no longer
applicable. Because tolerances on corn, pop, forage and corn, pop,
stover refer to the same commodity (i.e. duplicative) and because corn,
pop, stover is the most current terminology, the Agency has determined
the tolerance on corn, pop, forage should be removed. Therefore, EPA
proposes revising the tolerances in 40 CFR 180.352(a) for the

[[Page 6873]]

combined residues of terbufos and its cholinesterase-inhibiting
metabolites from corn, grain to corn, field, grain and corn, pop,
grain; sorghum, forage to sorghum, grain, forage; and sorghum, grain to
sorghum, grain, grain and removing corn, pop, forage.
The proposed tolerance actions herein for terbufos, to implement
the recommendations of the terbufos RED, reflect different method
levels of detection (LOD) where the LOD under the CODEX system is 0.01
ppm and the LOD under the U.S. system is 0.05 ppm which result in
differing Codex levels on banana, corn/maize, popcorn, sugar beets, and
sweet corn than the U.S. tolerances. Other differences in MRLs and
tolerances between CODEX and the U.S. exist for cereal grain straw,
fodder and stover because some are measured on a dry weight basis
versus a wet weight basis. Lastly, the CODEX levels have changed since
the tolerance reassessment such that, currently none of the U.S.
tolerances and CODEX tolerances are harmonized.
10. Tetrachlorvinphos. Currently, the residue of concern in 40 CFR
180.252(a)(1) is tetrachlorvinphos (2-chloro-1-(2,4,5-
trichlorophenyl)vinyl dimethyl phosphate). The chemical name of
tetrachlorvinphos as specified in 40 CFR 180.252 should be replaced
with the CAS chemical name: (Z)-2-chloro-1-(2,4,5-trichlorophenyl)vinyl
dimethyl phosphate. The Agency has also determined that the
metabolites, 1-(2,4,5-trichlorophenyl)-ethanol (free and conjugated
forms), 2,4,5-trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-
ethanediol are also of toxicological concern and should be regulated.
Therefore, EPA proposes revising the tolerance expression in 40 CFR
180.252(a)(1) to regulate the residues of the insecticide
tetrachlorvinphos ((Z)-2-chloro-1-(2,4,5-trichlorophenyl)vinyl dimethyl
phosphate) and its metabolites, 1-(2,4,5-trichlorophenyl)-ethanol (free
and conjugated forms), 2,4,5-trichloroacetophenone, and 1-(2,4,5-
trichlorophenyl)-ethanediol.
Currently, EPA has insufficient data to establish permanent
tolerances for milk, cattle, hog and poultry commodities; however, EPA
has been able to estimate tolerances for these livestock commodities
using existing animal metabolism data on an interim basis of 18 months
to permit time for the submission of additional data to support
permanent tolerances. The tolerances are also being revised to address
the additional tetrachlorvinphos metabolites of concern. Based on the
metabolism data which indicate the tetrachlorvinphos residues of
concern as high as 0.18 ppm in/on cattle and hog fat; 0.50 ppm in/on
cattle and hog kidney; 0.38 ppm in/on cattle and hog liver; 1.86 ppm
in/on cattle and hog meat; 0.50 ppm in/on cattle and hog meat
byproducts except kidney and liver; 0.02 ppm in milk; 0.19 ppm in/on
eggs; 6.1 ppm in/on poultry fat; 2.32 ppm in/on poultry meat; 1.27 ppm
in/on poultry liver and 1.27 ppm in/on meat byproducts except liver,
the Agency determined that interim tolerances should be established for
18 months at the decreased levels of 0.2 ppm (of which no more than 0.1
ppm is tetrachlorvinphos per se) in/on cattle and hog fat; and 0.05 ppm
(of which no more than 0.05 ppm is tetrachlorvinphos per se) in/on
milk, fat. The Agency also determined that interim tolerances should be
established for 18 months at 1.0 ppm (of which no more than 0.05 ppm is
tetrachlorvinphos per se) in/on cattle and hog kidney; 0.5 ppm (of
which no more than 0.05 ppm is tetrachlorvinphos per se) in/on cattle
and hog liver; 2.0 ppm (of which no more than 2.0 ppm is
tetrachlorvinphos per se) cattle and hog meat; 1.0 ppm in/on cattle and
hog meat byproducts except liver and kidney; 3.0 ppm (of which no more
than 3.0 ppm is tetrachlorvinphos per se) in/on poultry meat; 2.0 ppm
(of which no more than 0.05 ppm is tetrachlorvinphos per se) in/on
poultry liver; and 2.0 ppm in/on poultry meat byproducts except liver.
The Agency determined that interim tolerances should be established for
18 months at the increased level of 0.2 ppm (of which no more than 0.05
ppm is tetrachlorvinphos per se) in/on eggs; and 7.0 ppm (of which no
more than 7.0 ppm is tetrachlorvinphos per se) in/on poultry fat.
Therefore, EPA proposes revising and establishing 18-month time-limited
tolerances in newly proposed 40 CFR 180.252(a)(1) for residues of the
insecticide tetrachlorvinphos and its metabolites in/on cattle, fat and
hog, fat from 1.5 ppm to 0.2 ppm (of which no more than 0.1 ppm is
tetrachlorvinphos per se); cattle, kidney and hog, kidney at 1.0 ppm
(of which no more than 0.05 ppm is tetrachlorvinphos per se); cattle,
liver and hog, liver at 0.5 ppm (of which no more than 0.05 ppm is
tetrachlorvinphos per se); cattle, meat and hog, meat at 2.0 ppm (of
which no more than 2.0 ppm is tetrachlorvinphos per se); cattle, meat
byproducts except kidney and liver and hog, meat byproducts except
kidney and liver at 1.0 ppm; milk, fat at 0.05 ppm reflecting
negligible residues in whole milk (of which no more than 0.05 ppm is
tetrachlorvinphos per se); eggs from 0.1 to 0.2 ppm (of which no more
than 0.05 ppm is tetrachlorvinphos per se); poultry, fat from 0.7 to
7.0 ppm (of which no more than 7.0 ppm is tetrachlorvinphos per se);
poultry, meat at 3.0 ppm (of which no more than 3.0 ppm is
tetrachlorvinphos per se); poultry, liver at 2.0 ppm (of which no more
than 0.05 ppm is tetrachlorvinphos per se); and poultry, meat
byproducts except liver at 2.0 ppm all of which expire on [18 months
from the date of final publication]. 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.
Because the Agency is taking action to establish the time-limited
tolerances in/on cattle, hog and poultry commodities (above), the
Agency has determined that the exception that permits ``the safe use of
tetrachlorvinphos as an additive to beef cattle, dairy cattle, horse
and swine feed at the rates of 0.00015 lb per 100 lb body weight per
day for cattle and horses, and 0.00011 lb per 100 lb body weight per
day for swine'' is no longer necessary. In addition, any uses of
tetrachlorvinphos in/on horses destined for slaughter are prohibited.
Therefore, EPA proposes revoking the tolerances in 40 CFR 180.252(a)(1)
for residues of the insecticide tetrachlorvinphos in/on goat, fat at
0.5 ppm; horse, fat at 0.5 ppm; removing 40 CFR 180.252(a)(2); and
changing the designation of 40 CFR 180.252(a)(1) to 40 CFR 180.252(a).
Currently, there are no Codex MRLs in place for tetrachlorvinphos.

B. What is the Agency's Authority for Taking this Action?

A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a,
as amended by FQPA of 1996, Public Law 104-170, authorizes the
establishment of tolerances, exemptions from tolerance requirements,
modifications in tolerances, and revocation of tolerances for residues
of pesticide chemicals in or on raw agricultural commodities and
processed foods. Without a tolerance or exemption, food containing
pesticide residues is considered to be unsafe and therefore
``adulterated'' under section 402(a) of FFDCA, 21 U.S.C. 342(a). Such
food may not be distributed in interstate commerce (21 U.S.C. 331(a)).
For a food-use pesticide to be sold and distributed, the pesticide must
not only have appropriate tolerances under the FFDCA, but also must be
registered

[[Page 6874]]

under FIFRA (7 U.S.C. 136 et seq.). Food-use pesticides not registered
in the United States must have tolerances in order for commodities
treated with those pesticides to be imported into the United States.
EPA is proposing these tolerance actions to implement the tolerance
recommendations made during the reregistration and tolerance
reassessment processes (including follow-up on canceled or additional
uses of pesticides). As part of these processes, EPA is required to
determine whether each of the amended tolerances meets the safety
standard of FQPA. The safety finding determination is discussed in
detail in each post-FQPA RED and TRED for the active ingredient. REDs
and TREDs recommend the implementation of certain tolerance actions,
including modifications to reflect current use patterns, to meet safety
findings, and change commodity names and groupings in accordance with
new EPA policy. Printed and electronic copies of the REDs and TREDs are
available as provided in Unit II.A.
EPA has issued post-FQPA REDs (and Interim REDs) for 2,4-D,
bensulide, DCPA, desmedipham, dimethoate, fenamiphos, phorate,
sethoxydim, terbufos, and tetrachlorvinphos, whose REDs were completed
prior to FQPA. Also, EPA issued a RED prior to FQPA for
tetrachlorvinphos and made a safety finding which reassessed its
tolerances according to the FFDCA standard, maintaining them when new
tolerances were established as noted in Unit II.A. REDs and TREDs
contain the Agency's evaluation of the database for these pesticides,
including requirements for additional data on the active ingredients to
confirm the potential human health and environmental risk assessments
associated with current product uses, and in REDs state conditions
under which these uses and products will be eligible for
reregistration. The REDs and TREDs recommended the establishment,
modification, and/or revocation of specific tolerances. RED and TRED
recommendations such as establishing or modifying tolerances, and in
some cases revoking tolerances, are the result of assessment under the
FFDCA standard of ``reasonable certainty of no harm.'' However,
tolerance revocations recommended in REDs and TREDs that are proposed
in this document do not need such assessment when the tolerances are no
longer necessary.
EPA's general practice is to propose revocation of tolerances for
residues of pesticide active ingredients on crops for which FIFRA
registrations no longer exist and on which the pesticide may therefore
no longer be used in the United States. EPA has historically been
concerned that retention of tolerances that are not necessary to cover
residues in or on legally treated foods may encourage misuse of
pesticides within the United States. Nonetheless, EPA will establish
and maintain tolerances even when corresponding domestic uses are
canceled if the tolerances, which EPA refers to as ``import
tolerances,'' are necessary to allow importation into the United States
of food containing such pesticide residues. However, where there are no
imported commodities that require these import tolerances, the Agency
believes it is appropriate to revoke tolerances for unregistered
pesticides in order to prevent potential misuse.
Furthermore, as a general matter, the Agency believes that
retention of import tolerances not needed to cover any imported food
may result in unnecessary restriction on trade of pesticides and foods.
Under section 408 of FFDCA, a tolerance may only be established or
maintained if EPA determines that the tolerance is safe based on a
number of factors, including an assessment of the aggregate exposure to
the pesticide and an assessment of the cumulative effects of such
pesticide and other substances that have a common mechanism of
toxicity. In doing so, EPA must consider potential 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 for uses for which FIFRA registrations no longer exist, unless
someone expresses a need for such tolerances. Through this proposed
rule, the Agency is inviting individuals who need these import
tolerances to identify themselves and the tolerances that are needed to
cover imported commodities.
Parties interested in retention of the tolerances should be aware
that additional data may be needed to support retention. These parties
should be aware that, under FFDCA section 408(f), if the Agency
determines that additional information is reasonably required to
support the continuation of a tolerance, EPA may require that parties
interested in maintaining the tolerances provide the necessary
information. If the requisite information is not submitted, EPA may
issue an order revoking the tolerance at issue.
When EPA establishes tolerances for pesticide residues in or on raw
agricultural commodities, consideration must be given to the possible
residues of those chemicals in meat, milk, poultry, and/or eggs
produced by animals that are fed agricultural products (for example,
grain or hay) containing pesticides residues (40 CFR 180.6). When
considering this possibility, EPA can conclude that:
1. Finite residues will exist in meat, milk, poultry, and/or eggs.
2. There is a reasonable expectation that finite residues will
exist.
3. There is a reasonable expectation that finite residues will not
exist. If there is no reasonable expectation of finite pesticide
residues in or on meat, milk, poultry, or eggs, tolerances do not need
to be established for these commodities (40 CFR 180.6(b) and (c)).
EPA has evaluated certain specific meat, milk, poultry, and egg
tolerances proposed for revocation in this document and has concluded
that there is no reasonable expectation of finite pesticide residues of
concern in or on those commodities.

C. When Do These Actions Become Effective?

EPA is proposing that the tolerance actions herein become effective
on the date of publication of the final rule in the Federal Register.
The tolerances proposed for revocation in this document are associated
with uses that have been canceled for several years and none of the
other tolerance actions proposed herein are expected to result in
adulterated commodities. The Agency believes 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 revising the expiration date of the tolerance in the
final rule. 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 unit, any residues

[[Page 6875]]

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 a tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates when the
pesticide was applied to such food.

III. Are the Proposed Actions Consistent with International
Obligations?

The tolerance actions in this proposal are not discriminatory and
are designed to ensure that both domestically produced and imported
foods meet the food safety standards established by FFDCA. The same
food safety standards apply to domestically produced and imported
foods.
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international Maximum Residue Limits (MRLs) established
by the Codex Alimentarius is a joint U.N. Food and Agriculture
Organization/World Health Organization food standards program, and it
is recognized as an international food safety 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, FFDCA section 408(b)(4) requires that EPA explain the reasons
for departing from the Codex level in a notice published for public
comment. EPA's effort to harmonize with Codex MRLs is summarized in the
tolerance reassessment section of individual REDs and TREDs, and in the
Residue Chemistry document which supports the RED and TRED, as
mentioned in Unit II.A. Specific tolerance actions in this proposed
rule and how they compare to Codex MRLs (if any) are discussed in Unit
II.A.

IV. Statutory and Executive Order Reviews

In this proposed rule, EPA is proposing to establish tolerances
under FFDCA section 408(e), and also modify and revoke specific
tolerances 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) (FRL-5753-1),
respectively, and were provided to the Chief Counsel for Advocacy of
the Small Business Administration. Taking into account this analysis,
and available information concerning the pesticides listed in this
proposed rule, the Agency hereby certifies that this proposed rule will
not have a significant negative economic impact on a substantial number
of small entities. In a memorandum dated May 25, 2001, EPA determined
that eight conditions must all be satisfied in order for an import
tolerance or tolerance exemption revocation to adversely affect a
significant number of small entity importers, and that there is a
negligible joint probability of all eight conditions holding
simultaneously with respect to any particular revocation. (This Agency
document is available in the docket of this proposed rule).
Furthermore, for the pesticide named in this proposed rule, the Agency
knows of no extraordinary circumstances that exist as to the present
proposal that would change EPA's previous analysis. Any comments about
the Agency's determination should be submitted to EPA along with
comments on the proposal, and will be addressed prior to issuing a
final rule. In addition, the Agency has determined that this action
will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 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

[[Page 6876]]

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: January 22, 2008.
Marty Monell,
Acting Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

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.

2. Section 180.142 is amended by revising the entries for
``Grape,'' ``Fruit, pome, group 11,'' ``Fruit, stone, group 12,'' and
``Strawberry'' in the table in paragraph (a) to read as follows:

Sec. 180.142 2,4-D; tolerances for residues.

(a) General. * * *

* * * * *
3. Section 180.185 is amended by removing the entry for
``Vegetable, brassica, leafy, group 5'' from the table in paragraph (d)
and adding it alphabetically to the table in paragraph (a) to read as
follows.

Sec. 180.185 DCPA; tolerances for residues.

(a) General. * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Vegetable, brassica, leafy, group 5........................ 0.05
* * * * *
------------------------------------------------------------------------

* * * * *
4. Section 180.204 is amended by revising the table in paragraphs
(a) and (c) to read as follows:

Sec. 180.204 Dimethoate; tolerances for residues.

(a) General. * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage............................................ 2.0
Alfalfa, hay............................................... 2.0
Bean, dry, seed............................................ 2.0
Bean, lima................................................. 2.0
Bean, snap, succulent...................................... 2.0
Blueberry\1\............................................... 1.0
Broccoli................................................... 2.0
Cattle, meat byproducts.................................... 0.02
Cauliflower................................................ 2.0
Celery..................................................... 2.0
Citrus, dried pulp......................................... 5.0
Corn, field, forage........................................ 1.0
Corn, field, grain......................................... 0.1
Corn, field, stover........................................ 1.0
Corn, pop, grain........................................... 0.1
Corn, pop, stover.......................................... 1.0
Corn, sweet, forage........................................ 1.0
Cotton, undelinted seed.................................... 0.1
Egg........................................................ 0.02
Endive..................................................... 2.0
Goat, meat byproducts...................................... 0.02
Grapefruit................................................. 2.0
Hog, meat byproducts....................................... 0.02
Horse, meat byproducts..................................... 0.02
Kale....................................................... 2.0
Lemon...................................................... 2.0
Lettuce, leaf.............................................. 2.0
Melon...................................................... 1.0
Milk....................................................... 0.002
Mustard greens............................................. 2.0
Orange, sweet.............................................. 2.0
Pear....................................................... 2.0
Pea........................................................ 2.0
Pecan...................................................... 0.1
Pepper..................................................... 2.0
Potato..................................................... 0.2
Poultry, meat byproducts................................... 0.02
Safflower, seed............................................ 0.1
Sheep, meat byproducts..................................... 0.02
Sorghum, grain, forage..................................... 0.1
Sorghum, grain, grain...................................... 0.1
Sorghum, grain, stover..................................... 0.1
Soybean, seed.............................................. 0.05
Soybean, forage............................................ 2.0
Soybean, hay............................................... 2.0
Swiss chard................................................ 2.0
Tangerine.................................................. 2.0
Tomato..................................................... 2.0
Turnip, tops............................................... 2.0
Turnip, roots.............................................. 0.2
Wheat, forage.............................................. 2.0
Wheat, grain............................................... 0.04
Wheat, hay................................................. 2.0
Wheat, straw............................................... 2.0
------------------------------------------------------------------------
1There are U.S. registrations as of August 16, 1996.

* * * * *
(c) Tolerances with regional registrations. Tolerances with
regional registration, as defined in 180.1(m), are established for
total residues of dimethoate including its oxygen analog in or on the
following food commodities:

* * * * *
5. Section 180.206 is amended by revising paragraph (a) to read as
follows:

Sec. 180.206 Phorate; tolerances for residues.

(a) General. Tolerances are established for the combined residues
of the insecticide phorate (O,O-diethyl S[(ethylthio)
methyl]phosphorodithioate), phorate sulfoxide, phorate sulfone, phorate
oxygen analog, phorate oxygen analog sulfoxide, and phorate oxygen
analog sulfone in or on the following food commodities:

* * * * *
6. Section 180.241 is amended by revising the heading and
paragraphs (a) and (c) to read as follows:

Sec. 180.241 Bensulide; tolerances for residues.

(a) General. Tolerances are established for the residues of S-(O,O-
diisopropyl phosphorodithioate) of N-

[[Page 6877]]

(2-mercaptoethyl) benzenesulfonamide including its oxygen analog S-
(O,O-diisopropylphosphorodithioate) of N-(2-mercaptoethyl)
benzenesulfonamide in or on the following food commodities:

* * * * *
(c) Tolerances with regional registrations. Tolerances with
regional registration, as defined in 180.1(m), are established for the
residues of S-(O,O-diisopropyl phosphorodithioate) of N-(2-
mercaptoethyl) benzenesulfonamide including its oxygen analog S-(O,O-
diisopropylphosphorodithioate) of N-(2-mercaptoethyl)
benzenesulfonamide in or on the following food commodities:

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Carrot, roots.............................................. 0.10
------------------------------------------------------------------------

* * * * *
7. Section 180.252 is amended by revising paragraph (a) to read as
follows:

Sec. 180.252 Tetrachlorvinphos; tolerances for residues.

(a) General. Tolerances are established for the combined residues
of the insecticide tetrachlorvinphos ((Z)-2-chloro-1-(2,4,5-
trichlorophenyl) vinyl dimethyl phosphate) and its metabolites, 1-
(2,4,5-trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-
trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-ethanediol in/on
the following food commodities:

------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Cattle, fat (of which no more 0.2 [date 18 months
than 0.1 ppm is from the date of
tetrachlorvinphos per se) Final tolerance
publication]
Cattle, kidney (of which no more 1.0 [date 18 months
than 0.05 ppm is from the date of
tetrachlorvinphos per se) Final tolerance
publication]
Cattle, liver (of which no more 0.5 [date 18 months
than 0.05 ppm is from the date of
tetrachlorvinphos per se) Final tolerance
publication]
Cattle, meat (of which no more 2.0 [date 18 months
than 2.0 ppm is from the date of
tetrachlorvinphos per se) Final tolerance
publication]
Cattle, meat by products except 1.0 [date 18 months
kidney and liver from the date of
Final tolerance
publication]
Egg (of which no more than 0.05 0.2 [date 18 months
ppm is tetrachlorvinphos per from the date of
se) Final tolerance
publication]
Hog, fat (of which no more than 0.2 [date 18 months
0.1 ppm is tetrachlorvinphos from the date of
per se) Final tolerance
publication]
Hog, kidney (of which no more 1.0 [date 18 months
than 0.05 ppm is from the date of
tetrachlorvinphos per se) Final tolerance
publication]
Hog, liver (of which no more 0.5 [date 18 months
than 0.05 ppm is from the date of
tetrachlorvinphos per se) Final tolerance
publication]
Hog, meat (of which no more than 2.0 [date 18 months
2.0 ppm is tetrachlorvinphos from the date of
per se) Final tolerance
publication]
Hog, meat byproducts except 1.0 [date 18 months
kidney and liver from the date of
Final tolerance
publication]
Milk, fat (reflecting negligible 0.05 [date 18 months
residues in whole milk and of from the date of
which no more than 0.05 ppm is Final tolerance
tetrachlorvinphos per se) publication]
Poultry, fat (of which no more 7.0 [date 18 months
than 7.0 ppm is from the date of
tetrachlorvinphos per se) Final tolerance
publication]
Poultry, liver (of which no more 2.0 [date 18 months
than 0.05 ppm is from the date of
tetrachlorvinphos per se) Final tolerance
publication]
Poultry, meat (of which no more 3.0 [date 18 months
than 3.0 ppm is from the date of
tetrachlorvinphos per se) Final tolerance
publication]
Poultry, meat byproducts except 2.0 [date 18 months
liver from the date of
Final tolerance
publication]
------------------------------------------------------------------------

* * * * *
8. Section 180.349 is amended by revising paragraph (a) and the
table in paragraph (c) to read as follows:

Sec. 180.349 Fenamiphos; tolerances for residues.

(a) General. Tolerances are established for the combined residues
of the nematocide fenaminphos, (ethyl 3-methyl-4-(methylthio) phenyl
(1-methylethyl) phosphoramidate, and its cholinesterase inhibiting
metabolites ethyl 3-methyl-4-(methylsulfinyl) phenyl (1-methylethyl)
phosphoramidate and ethyl 3-methyl-4-(methylsulfonyl) phenyl (1-
methylethyl) phosporamidate in or on the following food commodities:

------------------------------------------------------------------------
Parts per Expiration/Revocation
Commodity million Date
------------------------------------------------------------------------
Apple.............................. 0.25 December 31, 2009
Banana\1\.......................... 0.10 None
Brussels sprouts................... 0.05 December 31, 2009
Cabbage............................ 0.10 December 31, 2009
Cherry, sweet...................... 0.25 December 31, 2009
Cherry, tart....................... 0.25 December 31, 2009
Citrus, dried pulp................. 2.5 None
Citrus, oil........................ 25.0 None
Eggplant........................... 0.05 December 31, 2009
Fruit, citrus, group 10\1\......... 0.50 None
Garlic\1\.......................... 0.50 None
Grape\1\........................... 0.10 None

[[Page 6878]]

Grape, raisin...................... 0.30 None
Okra............................... 0.30 December 31, 2009
Peach.............................. 0.25 December 31, 2009
Peanut............................. 1.0 December 31, 2009
Pineapple\1\....................... 0.30 None
Raspberry.......................... 0.10 December 31, 2009
Strawberry......................... 0.60 December 31, 2009
------------------------------------------------------------------------
\1\There are no U.S. registrations as of December 31, 2009.

* * * * *
(c) Tolerances with regional registrants. * * *

------------------------------------------------------------------------
Parts per Expiration/Revocation
Commodity million Date
------------------------------------------------------------------------
Asparagus.......................... 0.02 December 31, 2009
Beet, garden roots................. 1.5 December 31, 2009
Beet, garden, tops................. 1.0 December 31, 2009
Bok choy........................... 0.50 December 31, 2009
Kiwifruit.......................... 0.10 December 31, 2009
Pepper, nonbell.................... 0.60 December 31, 2009
------------------------------------------------------------------------

* * * * *
9. Section 180.352 is revised to read as follows:

Sec. 180.352 Terbufos; tolerances for residues.

(a) General. Tolerances are established for the combined residues
of the insecticide terbufos (phosphorodithioic acid, S-(t-
butylthio)methyl O,O-diethyl ester) and its phosphorylated
(cholinesterase-inhibiting) metabolites (phosphorothioic acid, S-(t-
butylthio)methyl O,O-diethyl ester; phosphorothioic acid, S-(t-
butylsulfinyl)methyl O,O-diethyl ester; phosphorothioic acid, S-(t-
butylsulfonyl)methyl O,O-diethyl ester; phosphorodithioic acid, S-(t-
butylsulfinyl)methyl O,O-diethyl ester; and phosphorodithioic acid, S-
(t-butylsulfonyl)methyl O,O-diethyl ester) in or on food commodities:

(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
10. Section 180.353 is amended by revising the table in paragraph
(a) to read as follows:

Sec. 180.353 Desmedipham; tolerances for residues.

(a) General.
* * * * *

* * * * *
11. Section 180.412 is amended by revising the table in paragraph
(a) to read as follows:

Sec. 180.412 Sethoxydim; tolerances for residues.

(a) General. * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage............................................ 40
Alfalfa, hay............................................... 40
Almond, hulls.............................................. 2.0
Apricot.................................................... 0.2
Apple, wet pomace.......................................... 0.8
Asparagus.................................................. 4.0
Bean, succulent............................................ 15
Beet, sugar, molasses...................................... 10
Beet, sugar, tops.......................................... 3.0
Blueberry.................................................. 4.0
Borage, meal............................................... 10
Borage, seed............................................... 6.0
Buckwheat, flour........................................... 25
Buckwheat, grain........................................... 19
Caneberry subgroup 13 A.................................... 5.0
Canola, meal............................................... 40
Canola, seed............................................... 35
Cattle, fat................................................ 0.2
Cattle, meat............................................... 0.2
Cattle, meat byproducts.................................... 1.0
Cherry, sweet.............................................. 0.2
Cherry, tart............................................... 0.2
Citrus, dried pulp......................................... 1.5
Clover, forage............................................. 35
Clover, hay................................................ 55
Coriander, leaves.......................................... 4.0
Corn, field, fodder........................................ 2.5
Corn, field, grain......................................... 0.5
Corn, field, stover........................................ 2.0
Corn, sweet, forage........................................ 3.0
Corn, sweet, kernel plus cob with husk removed............. 0.4
Corn, sweet, stover........................................ 3.5
Cotton, undelinted seed.................................... 5.0
Cowpea, forage............................................. 15
Cowpea, hay................................................ 50
Cranberry.................................................. 2.5
Dillweed, fresh leaves..................................... 10
Egg........................................................ 2.0
Flax, seed................................................. 5.0
Fruit, citrus, group 10.................................... 0.5
Fruit, pome, group 11...................................... 0.2
Goat, fat.................................................. 0.2
Goat, meat................................................. 0.2
Goat, meat byproducts...................................... 1.0
Grape...................................................... 1.0
Grape, raisin.............................................. 2.0
Hog, fat................................................... 0.2
Hog, meat.................................................. 0.2
Hog, meat byproducts....................................... 1.0
Horse, fat................................................. 0.2
Horse, meat................................................ 0.2
Horse, meat byproducts..................................... 1.0
Juneberry.................................................. 5.0
Lingonberry................................................ 5.0
Milk....................................................... 0.5
Nectarine.................................................. 0.2
Nut, tree, group 14........................................ 0.2
Okra....................................................... 2.5
Pea and bean, dried shelled, except soybean, subgroup 6C... 25
Pea, field, hay............................................ 40
Pea, field, vines.......................................... 20
Pea, succulent............................................. 10
Peach...................................................... 0.2
Peanut..................................................... 25
Peppermint, tops........................................... 30
Pistachio.................................................. 0.2
Potato granules/flakes..................................... 8.0
Potato waste, processed.................................... 8.0
Poultry, fat............................................... 0.2
Poultry, meat.............................................. 0.2

[[Page 6879]]

Poultry, meat byproducts................................... 2.0
Radish, tops............................................... 4.5
Rapeseed, meal............................................. 40
Rapeseed, seed............................................. 35
Safflower, seed............................................ 15
Salal...................................................... 5.0
Sheep, fat................................................. 0.2
Sheep, meat................................................ 0.2
Sheep, meat byproducts..................................... 1.0
Soybean, hay............................................... 10
Soybean, seed.............................................. 16
Spearmint, tops............................................ 30
Strawberry................................................. 10
Sunflower, meal............................................ 20
Sunflower, seed............................................ 7.0
Turnip, tops............................................... 5.0
Vegetable, brassica, leafy, group 5........................ 5.0
Vegetable, bulb, group 3................................... 1.0
Vegetable, cucurbit, group 9............................... 4.0
Vegetable, fruiting, group 8............................... 4.0
Vegetable, leafy, except brassica, group 4................. 4.0
Vegetable, root and tuber, group 1......................... 4.0
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-2094 Filed 2-5-08; 8:45 am]

BILLING CODE 6560-50-S