[Federal Register: July 14, 2006 (Volume 71, Number 135)]
[Proposed Rules]
[Page 40051-40057]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy06-19]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-2006-0056; FRL-8075-4]
Bentazon, Carboxin, Dipropyl Isocinchomeronate, and Oil of
Lemongrass (Oil of Lemon) and Oil of Orange; 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
fungicide carboxin, the insecticide dipropyl isocinchomeronate, and the
fungicide/animal repellent oil of lemon (oil of lemongrass) and oil of
orange. Also, EPA is proposing to modify certain tolerances for the
herbicide bentazon and the fungicide carboxin. In addition, EPA is
proposing to establish new tolerances for the herbicide bentazon. The
regulatory actions proposed in this document are part of the Agency's
reregistration program under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and the tolerance reassessment requirements of
the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as
amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA
is required by August 2006 to reassess the tolerances that were in
existence on August 2, 1996. No tolerance reassessments will be counted
at the time of a final rule because tolerances in existence on August
2, 1996 that are associated with actions proposed herein were
previously counted as reassessed at the time of the completed
Reregistration Eligibility Decision (RED), Report of Food Quality
Protection Act (FQPA) Tolerance Reassessment Progress and Risk
Management Decision (TRED), or Federal Register.
DATES: Comments must be received on or before September 12, 2006.
[[Page 40052]]
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0056, 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
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-
2006-0056. EPA's policy is that all comments 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 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. 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 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 Building), 2777 S. Crystal Drive,
Arlington, VA. The hours of operation for 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: Monisha Dandridge, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave, NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0410; e-mail
address: dandridge.monisha@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
http://www.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 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
[[Page 40053]]
submitted as required in the order, EPA will take appropriate action
under FFDCA.
EPA issues a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposal, you may also submit an objection
at the time of the final rule. If you fail to file an objection to the
final rule within the time period specified, you will have waived the
right to raise any issues resolved in the final rule. After the
specified time, issues resolved in the final rule cannot be raised
again in any subsequent proceedings.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to revoke, modify and establish specific
tolerances for residues of the herbicide bentazon, the fungicide
carboxin, the insecticide dipropyl isocinchomeronate, and the
fungicide/animal repellent oil of lemon (oil of lemongrass) and oil of
orange 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 FQPA. The safety finding determination of ``reasonable
certainty of no harm'' is discussed in detail in each Reregistration
Eligibility Decision (RED) and Report of the 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
http://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 http://www.ntis.gov.
Electronic copies of REDs and TREDs are available on the internet for
bentazon, carboxin, dipropyl isocinchomeronate, and flower and
vegetable oils (this refers to oil of lemongrass (oil of lemon) and oil
of orange) at http://www.epa.gov/pesticides/reregistration/status.htm,
and also for carboxin and dipropyl isocinchomeronate in public dockets
EPA-HQ-OPP-2004-0233, EPA-HQ-OPP-2004-0124 and, EPA-HQ-OPP-2003-0123,
respectively. Paper copies for bentazon and flower and vegetable oils,
which includes oil of lemon (oil of lemongrass) and oil of orange,
available in the public docket for this rule.
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. 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 and (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.
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 carboxin can be found under its respective
public docket number EPA-HQ-OPP-2004-0124, identified above. Paper
copies for bentazon are available in the public docket for this rule.
Because food use registrations have not existed for oil of lemon (oil
of lemongrass), oil of orange, and dipropyl isocinchomeronate, the
Agency residue assessment was not needed. Electronic copies are
available through EPA's electronic public docket and comment system,
regulations.gov at http://www.regulations.gov. You may search for this
rule under docket number EPA-HQ-OPP--2006-0056, or for an individual
chemical under its respective docket number, then click on that docket
number to view its contents.
The aggregate exposures and risks are not of concern for the
pesticide active ingredient bentazon, carboxin, dipropyl
isocinchomeronate, and oil of lemon (oil of lemongrass) and oil of
orange 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 established or 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 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 canceled
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. Bentazon. The available residue data for bentazon indicate that
the established tolerances for cowpea, forage; pea, dry, seed; pea,
field, hay; soybean, forage; and soybean, hay should be increased.
Therefore, EPA is proposing to increase tolerances in 40 CFR
180.355(a)(1) for the residues of bentazon in or on cowpea, forage from
3.0 to 10.0 ppm; pea, dry, seed from 0.05 to 1.0 ppm; pea, field, hay
from 3.0 to 8.0; soybean, forage from 3.0 to 8.0 ppm and soybean, hay
from 3.0 to 8.0 ppm. The Agency has determined that
[[Page 40054]]
the increased tolerances are safe; i.e., there is no reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue.
The Agency determined that the tolerance on pepper, nonbell should
be decreased to 0.05 ppm, which is the limit of detection for bentazon
residues of concern. Therefore, the Agency is proposing to decrease the
tolerances in 40 CFR 180.355(a)(1) for the combined residues of
bentazon and its metabolites in or on pepper, nonbell to 0.05 ppm.
The processing data on rice indicate the residues concentrate in
hulls. Therefore, EPA is proposing to establish a tolerance in 40 CFR
180.355(a)(1) for the combined residues of bentazon and its metabolites
in or on rice, hulls at 0.25 ppm.
In order to conform to current Agency policy on commodity
terminology, EPA is proposing to modify the tolerance in 40 CFR
180.355(a)(1), for residues of bentazon in or on mint to peppermint,
tops and spearmint, tops and maintain the tolerance level at 1.0 ppm.
2. Carboxin. According to the TRED, the tolerance expression, which
is currently expressed as ``combined residues of the fungicide carboxin
(5,6-dihydro-2-methyl-1,4-oxathiin-3-carboxanilide) and its metabolite
5,6-dihydro-3-carboxanilide-2-meth yl-1,4-oxathiin-4-oxide (calculated
as carboxin) (from treatment of seed prior to planting) in or on raw
agricultural commodities as follows'' in 40 CFR 180.301(a) should be
modified. The residue chemistry data indicates that as crops mature,
insoluble anilide complexes as well as polar metabolites increased.
These complexes of carboxin or carboxin derivatives with macromolecules
such as lignin are insoluble in water and organic solvents and liberate
aniline upon hydrolysis. Further, analytical methods for detection of
carboxin regulated residues produce aniline (convert carboxin and
carboxin derived metabolite to aniline), which is determined either
spectrophotometrically or by gas-liquid chromatography (GLC).
Therefore, the residues of concern are carboxin, carboxin sulfoxide,
and insoluble anilide complexes. Consequently, EPA is proposing that
the tolerance expression in 40 CFR 180.301(a) read as follows: ``(a)
General. Tolerances are established for the combined residues of the
fungicide carboxin (5,6-dihydro-2-methyl-1,4-oxathiin-3-carboxanilide)
and its metabolites determined as aniline and expressed as parent
compound, in or on food commodities as follows:''
Because bean forage, hay, and straw are no longer considered
significant livestock feed stuffs and have been deleted from Table
OPPTS 860.1000 (available at http://www.epa.gov/opptsfrs /OPPTS--
Harmonized/ 860-- Residue--Chemistry-- Test--Guidelines/Series); the
tolerances are no longer needed. Therefore, EPA is proposing to revoke
the tolerances in 40 CFR 180.301(a) on bean, forage; bean, hay; and
bean, straw.
Carboxin has had no active registrations for uses on sorghum over a
period of many years. Therefore, EPA is proposing to revoke the
tolerances in 40 CFR 180.301(a) for residues of carboxin in or on
sorghum are no longer needed, EPA is proposing to revoke the tolerances
in 40 CFR 180.301(a) for sorghum, forage; sorghum, grain; and sorghum,
grain, stover.
Based on the ruminant feeding study, the lack of residues detected
on the poultry feedstuff produced from treated seeds and the use of
carboxin only as a fungicide on seeds indicate there is no propensity
for residues to accumulate in animal tissues, the tolerance should be
established at the level of quantitation of the analytical method of
0.05 ppm rather than the current tolerance level of 0.01 ppm.
Therefore, EPA is proposing to increase the tolerances in 40 CFR
180.301(a) for combined residues of carboxin and its metabolites in or
on egg from 0.01 to 0.05 ppm. The Agency has determined that the
increased tolerances are safe; i.e., there is a reasonable certainty
that no harm will result from aggregate exposure to the pesticide
chemical residue.
Based on 14C-radiolabeled dairy cattle feeding data at
an exaggerated 1.15x feeding level, milk showed combined carboxin
residues of concern. The 14C-radiolabeled feeding study had
a lower limit of quantitation (LOQ) than the enforcement method and
therefore the tolerance should be established at the LOQ of the
enforcement analytical method (0.05 ppm). Therefore, EPA is proposing
to increase the tolerance in 40 CFR 180.301(a) for combined residues of
carboxin and its metabolites in or on ``milk'' from 0.01 to 0.05 ppm.
The Agency has 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.
A dairy cattle feeding study conducted at an exaggerated (1.15x)
feeding level, shows combined carboxin regulated residues were as low
as 0.023 and 0.007 ppm in meat and fat. Therefore, EPA is proposing to
decrease the tolerances in 40 CFR 180.301(a) for residues of carboxin
in or on the meat and fat of cattle, goats, hogs, horses, and sheep
from 0.01 to 0.05 ppm, respectively.
In order to conform to current Agency practice, EPA is proposing to
revise the commodity terminology in 40 CFR 180.301(a), for residues of
carboxin in or on corn, stover to read corn, field, stover; corn, pop,
stover and corn, sweet, stover; corn, forage to corn, field, forage;
and, corn, sweet, forage; ``corn, fresh, including sweet corn, kernel
plus cob with husks removed to read corn, sweet, kernel plus cob with
husks removed; corn, grain to corn, field, grain and corn, pop, grain;
oat, seed to read oat, grain; rice to rice, grain; and soybean to read
soybean, seed.
3. Dipropyl isocinchomeronate (MGK 326). There have been no active
registrations for uses associated with livestock or milk commodities
since 1996, such that these tolerances are no longer needed, and
therefore EPA is proposing to revoke the commodity tolerances in 40 CFR
180.143(a) for residues of dipropyl isocinchomeronate in or on cattle,
fat; cattle, meat; cattle, meat byproducts; goat, fat; goat, meat;
goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts;
horse, fat; horse, meat; horse, meat byproducts; milk; sheep, fat;
sheep, meat; and, sheep, meat byproducts.
4. Oil of lemongrass (oil of lemon) and oil of orange. Oil of lemon
is not a registered pesticide active ingredient nor has it ever been an
active ingredient in any pesticide product. However, the Agency has
determined that the exemptions from the requirement of a tolerance
under 40 CFR 180.1238 apply to Oil of lemongrass, which is a registered
active ingredient included in the 1993 RED entitled Flower and
Vegetable Oils. There have been no active food-use registrations within
the past 10 years which contain either oil of lemongrass or oil of
orange as pesticide active ingredients. Therefore, EPA is proposing to
revoke the tolerance exemptions on raw agricultural commodities in 40
CFR 180.1238 and 180.1239 for oil of lemon (oil of lemongrass) and oil
of orange, respectively, when used as a postharvest fungicide.
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,
[[Page 40055]]
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 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 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 a post-FQPA RED for carboxin and dipropyl
isocinchomeronate (MGK 326), and a pre-FQPA RED for bentazon, whose
tolerances were reassessed post-FQPA as part of the Agency's
determination on March 8, 2000 (65 FR 12122) (FRL-6492-7) to establish
new bentazon uses and therefore a TRED to reassess its tolerances was
not needed. Also, EPA has issued a TRED for oil of lemongrass (oil of
lemon) and oil of orange, as these active ingredients were part of the
Flower and Vegetable Oils pre FQPA RED. 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,
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
FQPA 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.
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 revocations, modifications, and
establishments of tolerances, and commodity terminology revisions
become effective on the date of publication of the final rule in the
Federal Register. For this rule, proposed revocations will affect
tolerances for uses which have been canceled for many years or are no
longer needed. 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
[[Page 40056]]
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.
D. What Is the Contribution to Tolerance Reassessment?
By law, EPA is required by August 3, 2006 to reassess the
tolerances in existence on August 2, 1996. As of May 30, 2006, EPA has
reassessed over 8,140 tolerances. Regarding tolerances mentioned in
this proposed rule, tolerances in existence as of August 2, 1996 were
previously counted as reassessed at the time of the signature
completion of a post-FQPA RED or TRED for each active ingredient.
Therefore, no further tolerance reassessments would be counted toward
the August 2006 review deadline.
III. Are The Proposed Actions Consistent with International
Obligations?
The tolerance revocations in this proposal are not discriminatory
and are designed to ensure that both domestically-produced and imported
foods meet the food safety standard established by the FFDCA. The same
food safety standards apply to domestically produced and imported
foods.
EPA is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. EPA considers
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in
reassessing them. MRLs are established by the Codex Committee on
Pesticide Residues, a committee within the Codex Alimentarius
Commission, an international organization formed to promote the
coordination of international food standards. It is EPA's policy to
harmonize U.S. tolerances with Codex MRLs to the extent possible,
provided that the MRLs achieve the level of protection required under
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the
tolerance reassessment section of individual Reregistration Eligibility
Decision documents. EPA has developed guidance concerning submissions
for import tolerance support of June 1, 2000, (65 FR 35069 FRL-6559-3).
This guidance will be made available to interested persons. Electronic
copies are available on the internet at http://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 http://www.epa.gov/fedrgstr.
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 (i.e.,
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) (Pub. 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), Pub. 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
[[Page 40057]]
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
``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: July 5, 2006.
James Jones,
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.
Sec. 180.143 [Removed]
2. Section 180.143 is removed.
3. Section 180.301 is amended by revising paragraph (a) to read as
follows:
Sec. 180.301 Carboxin; tolerances for residues.
(a) General. Tolerances are established for the combined residues
of the fungicide carboxin (5,6-dihydro-2-methyl-1,4-oxathiin-3-
carboxanilide) and its metabolites determined as aniline and expressed
as parent compound, in or on food commodities as follows:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Barley, grain........................................ 0.2
Barley, straw........................................ 0.2
Bean, dry, seed...................................... 0.2
Bean, succulent...................................... 0.2
Canola, seed......................................... 0.03
Cattle, fat.......................................... 0.05
Cattle, meat......................................... 0.05
Cattle, meat byproducts.............................. 0.1
Corn, field, forage.................................. 0.2
Corn, field, grain................................... 0.2
Corn, field, stover.................................. 0.2
Corn, pop, grain..................................... 0.2
Corn, pop, stover.................................... 0.2
Corn, sweet, forage.................................. 0.2
Corn, sweet, kernel plus cob with husks removed...... 0.2
Corn, sweet, stover.................................. 0.2
Cotton, undelinted seed.............................. 0.2
Egg.................................................. 0.05
Goat, fat............................................ 0.05
Goat, meat........................................... 0.05
Goat, meat byproducts................................ 0.1
Hog, fat............................................. 0.05
Hog, meat............................................ 0.05
Hog, meat byproducts................................. 0.1
Horse, fat........................................... 0.05
Horse, meat.......................................... 0.05
Horse, meat byproducts............................... 0.1
Milk................................................. 0.05
Oat, forage.......................................... 0.5
Oat, grain........................................... 0.2
Oat, straw........................................... 0.2
Onion, bulb.......................................... 0.2
Peanut............................................... 0.2
Peanut, hay.......................................... 0.2
Poultry, fat......................................... 0.1
Poultry, meat........................................ 0.1
Poultry, meat byproducts............................. 0.1
Rice, grain.......................................... 0.2
Rice, straw.......................................... 0.2
Safflower, seed...................................... 0.2
Sheep, fat........................................... 0.05
Sheep, meat.......................................... 0.05
Sheep, meat byproducts............................... 0.1
Soybean, seed........................................ 0.2
Wheat, forage........................................ 0.5
Wheat, grain......................................... 0.2
Wheat, straw......................................... 0.2
------------------------------------------------------------------------
* * * * *
4. Section 180.355 is amended by revising the table in paragraph
(a) to read as follows:
Sec. 180.355 Bentazon; tolerances for residues.
(a) General. * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Bean, dry, seed...................................... 0.05
Bean, succulent...................................... 0.5
Corn, field, forage.................................. 3.0
Corn, field, grain................................... 0.05
Corn, field, stover.................................. 3.0
Corn, pop, grain..................................... 0.05
Corn, sweet, kernel plus cob with husks removed...... 0.05
Cowpea, forage....................................... 10.0
Cowpea, hay.......................................... 3.0
Flax, seed........................................... 1.0
Pea, dry, seed....................................... 1.0
Pea, field, hay...................................... 8.0
Pea, field, vines.................................... 3.0
Pea, succulent....................................... 3.0
Peanut............................................... 0.05
Peanut, hay.......................................... 3.0
Pepper, nonbell...................................... 0.05
Peppermint, tops..................................... 1.0
Rice, grain.......................................... 0.05
Rice, hulls.......................................... 0.25
Rice, straw.......................................... 3.0
Sorghum, forage...................................... 0.20
Sorghum, grain....................................... 0.05
Sorghum, grain, stover............................... 0.05
Soybean, seed........................................ 0.05
Soybean, forage...................................... 8.0
Soybean, hay......................................... 8.0
Spearmint, tops...................................... 1.0
------------------------------------------------------------------------
* * * * *
Sec. Sec. 180.1238 and 180.1239 [Removed]
5. Sections 180.1238 and 180.1239 are removed.
[FR Doc. E6-11016 Filed 7-13-06; 8:45 am]
BILLING CODE 6560-50-S