Dimethenamid; Pesticide Tolerance, 49350-49354 [E6-13660]
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Federal Register / Vol. 71, No. 163 / Wednesday, August 23, 2006 / Rules and Regulations
adopted by voluntary consensus
standards bodies.
This rule does not use technical
standards. Therefore, we did not
consider the use of voluntary consensus
standards.
Environment
We have analyzed this rule under
Commandant Instruction M16475.1D,
and Department of Homeland Security
Management Directive 5100.1, which
guide the Coast Guard in complying
with the National Environmental Policy
Act of 1969 (NEPA) (42 U.S.C. 4321–
4370f), and have concluded that there
are no factors in this case that would
limit the use of a categorical exclusion
under section 2.B.2 of the Instruction.
Therefore, this rule is categorically
excluded, under figure 2–1, paragraph
(32)(e) of the Instruction, from further
environmental documentation
considering that it relates to the
promulgation of operating regulations or
procedures for drawbridges. Under
figure 2–1, paragraph (32)(e) of the
Instruction, an ‘‘Environmental Analysis
Check List’’ and a ‘‘Categorical
Exclusion Determination’’ are not
required for this rule.
List of Subjects in 33 CFR Part 117
Bridges.
I For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 117 as follows:
PART 117—DRAWBRIDGE
OPERATION REGULATIONS
1. The authority citation for part 117
continues to read as follows:
I
Authority: 33 U.S.C. 499; 33 CFR 1.05–1(g);
Department of Homeland Security Delegation
No. 0170.1; section 117.255 also issued under
the authority of Public Law 102–587, 106
Stat. 5039.
2. From September 8, 2006 through
December 30, 2006, § 117.795 is
amended by suspending paragraph (b)
and adding a temporary paragraph (d),
to read as follows:
I
§ 117.795 Jamaica Bay and Connecting
Waterways.
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*
*
*
*
*
(d)(1) The New York City Highway
Bridge (Belt Parkway), mile 0.8, across
Mill Basin, need only open one
moveable span for the passage of vessel
traffic from March 8, 2006 through
December 30, 2006. The draw need not
be opened for the passage of vessel
traffic from 12 p.m. to 9 p.m. on
Sundays from May 15 through
September 30, and on Memorial Day,
Independence Day, and Labor Day.
However, on these days the draw shall
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open on signal from the time two hours
before to one hour after the predicted
high tide(s).
(2) For the purpose of this section,
predicted high tide(s) occur 15 minutes
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Hook, as documented in the tidal
current data, which is updated,
generated and published by the National
Oceanic and Atmospheric
Administration/National Ocean Service.
Dated: August 7, 2006.
Timothy S. Sullivan,
Rear Admiral, U.S. Coast Guard, Commander,
First Coast Guard District.
[FR Doc. E6–13895 Filed 8–22–06; 8:45 am]
BILLING CODE 4910–15–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0165; FRL–8079–3]
Dimethenamid; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of dimethenamid
in or on leek;onion, green; onion,Welsh;
shallot, fresh leaves. Interregional
Research Project No.4 (IR-4) requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA).
DATES: This regulation is effective
August 23, 2006. Objections and
requests for hearings must be received
on or before October 23, 2006, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0165. All documents in the
docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information (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
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Building),
PO 00000
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2777 S. Crystal Drive, Arlington, VA.
The Docket Facility is open 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:
Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001; telephone number:
(703) 305-6463; e-mail address:
Madden.Barbara@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 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
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Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gpo/
opptsfrs/home/guidelin.htm
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C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2006–0165 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before October 23, 2006.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2006–0165, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S-4400, One
Potomac Yard (South 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) 3055805.
II. Background and Statutory Findings
In the Federal Register of March 22,
2006 (71 FR 14521) (FRL–7766–7), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
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pesticide petition (PP 4E6844) by
Interregional Research Project No. 4 (IR4), Technology Center of New Jersey,
Rutgers, the State University of New
Jersey, 681 U.S. Highway #1 South,
North Brunswick, NJ 08902-3390. The
petition requested that 40 CFR 180.464
be amended by establishing a tolerance
for residues of the herbicide
dimethenamid, (R,S)-2-chloro-N-[(1methyl-2-methoxy) ethyl]-N-(2,4dimethylthien-3-yl)-acetamide in or on
the raw agricultural commodities:
onion, green at 0.01 parts per million
(ppm); leek at 0.01 ppm; onion, Welsh
at 0.01 ppm; and shallot, fresh leaves at
0.01 ppm. That notice included a
summary of the petition prepared by
BASF Corporation, the registrant. There
were no comments received in response
to the notice of filing.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue....’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of the
FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and
Determination of Safety
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA, for a tolerance for residues of
dimethenamid, (R,S)-2-chloro-N-(1methyl-2-methoxy) ethyl-N-(2,4-
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dimethylthien-3-yl)-acetamide in or on
the raw agricultural commodities:
onion, green at 0.01 ppm; leek at 0.01
ppm; onion, Welsh at 0.01 ppm; and
shallot, fresh leaves at 0.01 ppm. EPA’s
assessment of exposures and risks
associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the toxic effects caused by
dimethenamid as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://www.epa.gov/
fedrgstr/EPA-PEST/2004/September/
Day-24/p21501.htm.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which no adverse
effects are observed (the NOAEL) from
the toxicology study identified as
appropriate for use in risk assessment is
used to estimate the toxicological level
of concern (LOC). However, the lowest
dose at which adverse effects of concern
are identified (the LOAEL) is sometimes
used for risk assessment if no NOAEL
was achieved in the toxicology study
selected. An uncertainty factor (UF) is
applied to reflect uncertainties inherent
in the extrapolation from laboratory
animal data to humans and in the
variations in sensitivity among members
of the human population as well as
other unknowns.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases. More
information can be found on the general
principles EPA uses in risk
characterization at https://www.epa.gov/
pesticides/health/human.htm.
A summary of the toxicological
endpoints for dimethenamid used for
human risk assessment is discussed in
Unit III.B. of the final rule published in
the Federal Register of September 24,
2004 (69 FR 57197) (FRL–7680–1).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.464) for the
residues of dimethenamid in or on a
variety of raw agricultural commodities.
Risk assessments were conducted by
EPA to assess dietary exposures from
chemical name in food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a one-day or
single exposure.
The Dietary Exposure Evaluation
Model software with the Food
Commodity Intake Database (DEEMFCIDTM, Version 1.3) which
incorporates food consumption data as
reported by respondents in the USDA
1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated
exposure to the chemical for each
commodity. The following assumptions
were made for the acute exposure
assessments: one hundred percent of
proposed and registered crops are
treated with dimethenamid (100% CT)
and tolerance-level residues for all
commodities.
ii. Chronic exposure.
In conducting the chronic dietary
exposure assessment EPA used the
Dietary Exposure Evaluation Model
software with the Food Commodity
Intake Database (DEEM-FCIDTM,
Version 1.3) which incorporates food
consumption data as reported by
respondents in the USDA 1994-1996
and 1998 Nationwide Continuing
Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to
the chemical for each commodity. The
following assumptions were made for
the chronic exposure assessments: one
hundred percent of proposed and
registered crops are treated with
dimethenamid (100% CT) and
tolerance-level residues for all
commodities
iii. Cancer. Dimethenamid (50:50 S:R
isomers) was classified as a group <2005
15:49 Aug 22, 2006
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(males). The incidence of liver tumors
was just slightly increased from the
level in the historical control data.
Higher doses did not demonstrate the
occurrence of liver adenomas
significantly different from the controls.
No dose-related tumors were seen in the
mouse carcinogenicity study, and a
battery of mutagenicity studies with
dimethenamid-P (90:10 S:R isomers)
were negative or equivocal for genetic
mutations including unscheduled DNA
synthesis.
2. Dietary exposure from drinking
water.
The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
dimethenamid in drinking water.
Because the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the physical characteristics of
dimethenamid. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the PRZM/EXAMS and SCIGROW models, the estimated
environmental concentrations (EECs) of
dimethenamid for acute exposures are
estimated to be 49 parts per billion
(ppb) for surface water and 0.42 ppb for
ground water. The EECs for chronic
exposures are estimated to be 7.9 ppb
for surface water and 0.42 ppb for
ground water.Modeled estimates of
drinking water concentrations were
directly entered into the dietary
exposure model (DEEM-FCIDTM,
Version 1.3). For acute dietary risk
assessment, the peak water
concentration value of 49 ppb was used
to access the contribution to drinking
water. For chronic dietary risk
assessment, the annual average
concentration of 7.9 ppb was used to
access the contribution to drinking
water
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Dimethenamid is not registered for
use on any sites that would result in
residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
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‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
dimethenamid and any other substances
and dimethenamid does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
not assumed that dimethenamid has a
common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see the policy statements
released by EPA’s Office of Pesticide
Programs concerning common
mechanism determinations and
procedures for cumulating effects from
substances found to have a common
mechanism on EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional tenfold margin of safety for
infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the data base on
toxicity and exposure unless EPA
determines based on reliable data that a
different margin of safety will be safe for
infants and children. Margins of safety
are incorporated into EPA risk
assessments either directly through use
of a MOE analysis or through using
uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk to humans. In applying
this provision, EPA either retains the
default value of 10X when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional safety
factor value based on the use of
traditional uncertainty factors and/or
special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
No offspring pre- or postnatal
susceptibility to either dimethenamid
(50:50 S:R isomers) or dimethenamid-P
(90:10 S:R isomers) was seen in a rabbit
or two rat developmental studies and
reproduction study. There is low
concern for pre- or postnatal toxicity
since the developmental effects from the
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[S] and [RS] mixture are similar and
occur at similar doses.
3. Conclusion. There is a complete
toxicity data base for dimethenamid and
exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures.
EPA determined that the safety factor
for dimethenamid should be 100 (10X
safety factor for interspecies
extrapolation and 10X for intraspecies
variation). The additional FQPA SF was
removed taking into account the low
concerns and lack residual uncertainties
with regard to prenatal and postnatal
toxicity and the completeness of the
toxicity and exposure data base.
E. Aggregate Risks and Determination of
Safety
The Agency currently has two ways to
estimate total aggregate exposure to a
pesticide from food, drinking water, and
residential uses. First, a screening
assessment can be used, in which the
Agency calculates drinking water levels
of comparison (DWLOCs) which are
used as a point of comparison against
estimated drinking water concentrations
(EDWCs). The DWLOC values are not
regulatory standards for drinking water,
but are theoretical upper limits on a
pesticide’s concentration in drinking
water in light of total aggregate exposure
to a pesticide in food and residential
uses. More information on the use of
DWLOCs in dietary aggregate risk
assessments can be found at https://
www.epa.gov/oppfead1/trac/science/
screeningsop.pdfMore recently the
Agency has used another approach to
estimate aggregate exposure through
food, residential and drinking water
pathways. In this approach, modeled
surface and ground water EDWCs are
directly incorporated into the dietary
exposure analysis, along with food. This
provides a more realistic estimate of
exposure because actual body weights
and water consumption from the CSFII
are used. The combined food and water
exposures are then added to estimated
exposure from residential sources to
calculate aggregate risks. The resulting
exposure and risk estimates are still
considered to be high end, due to the
assumptions used in developing
drinking water modeling inputs.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
dimethenamid will occupy <1% of the
aPAD for females 13 years and older.
Therefore, EPA does not expect the
aggregate exposure to exceed 100% of
the aPAD.
2. Chronic risk. Using the exposure
assumptions described in this unit for
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chronic exposure, EPA has concluded
that exposure to dimethenamid food
and water will utilize <1 % of the cPAD
for the U.S. population, 1.2 % of the
cPAD for all infants < 1 year old, the
subpopulation at greatest exposure, and
<1 % of the cPAD for children 1-2 years
old. There are no residential uses for
dimethenamid. Therefore, EPA does not
expect the aggregate exposure to exceed
100% of the cPAD.
3. Short-term and Intermediate-term
risk.
Short-term and Intermediate-term
aggregate exposures take into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Dimethenamid is not registered for
use on any sites that would result in
residential exposure. Therefore, the
aggregate risk is the sum of the risk from
food and water, which do not exceed
the Agency’s level of concern.
4. Aggregate cancer risk for U.S.
population. The Agency considers the
chronic aggregate risk assessment,
making use of the cPAD, to be protective
of any aggregate cancer risk. See Unit
III.E.2.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, and to infants and children
from aggregate exposure to
dimethenamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(AM-0884-0193-1) is available to enforce
the tolerance expression. AM-08840193-1 is a gas chromatography (GC)
method using an HP-1 or HP-5 column
and mass selective detection (MSD). The
method may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; email address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or
Mexican MRLs for dimethenamid in or
on the proposed commodities.
Therefore, harmonization of tolerances
is not an issue.
V. Conclusion
Therefore, tolerance are established
for residues of dimethenamid, (R,S)-2chloro-N-[(1-methyl-2-methoxy) ethyl]N-(2,4-dimethylthien-3-yl)-acetamide in
or on the commodities onion, green at
0.01 ppm; leek at 0.01 ppm; onion,
Welsh at 0.01 ppm; and shallot, fresh
leaves at 0.01 ppm.
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VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866 due to its lack of
significance, this 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 final 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 under 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 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). Since
tolerances and exemptions that are
established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. 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
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Federal Register / Vol. 71, No. 163 / Wednesday, August 23, 2006 / Rules and Regulations
sroberts on PROD1PC70 with RULES
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 final 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 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
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 rule.
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
VerDate Aug<31>2005
15:49 Aug 22, 2006
Jkt 208001
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 7, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.464 is amended by
alphabetically adding commodities to
the table in paragraph (a) to read as
follows:
I
§ 180.464
residues.
Dimethenamid; tolerances for
(a) * * *
Commodity
Parts per million
*
*
*
Leek
*
*
*
*
*
*
*
*
*
*
*
0.01
Onion, green
Onion, Welsh
*
*
0.01
0.01
*
Shallot, fresh leaves
*
*
*
0.01
[FR Doc. E6–13660 Filed 8–22–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0461; FRL–8078–1]
Triflumizole; Pesticide Tolerances for
Emergency Exemptions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
time-limited tolerances for combined
residues of triflumizole in or on turnip,
greens. Additionally, this regulation
increases the tolerance levels and
extends time–limited tolerances for
Chinese Napa cabbage, collards,
coriander leaves (cilantro), kale,
kohlrabi, mustard greens and parsley.
Further, this regulation extends time–
limited tolerances for broccoli,
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
dandelion and Swiss chard. This action
is in response to EPA’s granting of
emergency exemptions under section 18
of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA)
authorizing use of the pesticide on
parsley, dandelion, Swiss chard,
collards, kale, kohlrabi, mustard greens,
Chinese Napa cabbage, broccoli,
coriander leaves (cilantro), and turnip
greens. This regulation establishes,
revises, and/or extends a maximum
permissible level for residues of
triflumizole in these food commodities.
These tolerances expire and are revoked
on December 31, 2009.
DATES: This regulation is effective
August 23, 2006. Objections and
requests for hearings must be received
on or before October 23, 2006, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION.
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0461. All documents in the
docket are listed on the regulations.gov
website. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either in the electronic docket
at https://www.regulations.gov, or, if only
available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S–4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive Arlington, VA. The hours
of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Libby Pemberton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9364; e–mail address: Sec–
18–Mailbox@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
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Agencies
[Federal Register Volume 71, Number 163 (Wednesday, August 23, 2006)]
[Rules and Regulations]
[Pages 49350-49354]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-13660]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0165; FRL-8079-3]
Dimethenamid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
dimethenamid in or on leek;onion, green; onion,Welsh; shallot, fresh
leaves. Interregional Research Project No.4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective August 23, 2006. Objections and
requests for hearings must be received on or before October 23, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0165. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (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 https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open 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: Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6463; e-mail address: Madden.Barbara@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 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing
[[Page 49351]]
Office's pilot e-CFR site at https://www.gpoaccess.gov/ecfr. To access
the OPPTS Harmonized Guidelines referenced in this document, go
directly to the guidelines at https://www.epa.gpo/opptsfrs/home/
guidelin.htm
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0165 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 23, 2006.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0165, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
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.
II. Background and Statutory Findings
In the Federal Register of March 22, 2006 (71 FR 14521) (FRL-7766-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4E6844) by Interregional Research Project No. 4 (IR-4), Technology
Center of New Jersey, Rutgers, the State University of New Jersey, 681
U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The
petition requested that 40 CFR 180.464 be amended by establishing a
tolerance for residues of the herbicide dimethenamid, (R,S)-2-chloro-N-
[(1-methyl-2-methoxy) ethyl]-N-(2,4-dimethylthien-3-yl)-acetamide in or
on the raw agricultural commodities: onion, green at 0.01 parts per
million (ppm); leek at 0.01 ppm; onion, Welsh at 0.01 ppm; and shallot,
fresh leaves at 0.01 ppm. That notice included a summary of the
petition prepared by BASF Corporation, the registrant. There were no
comments received in response to the notice of filing.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of dimethenamid,
(R,S)-2-chloro-N-(1-methyl-2-methoxy) ethyl-N-(2,4-dimethylthien-3-yl)-
acetamide in or on the raw agricultural commodities: onion, green at
0.01 ppm; leek at 0.01 ppm; onion, Welsh at 0.01 ppm; and shallot,
fresh leaves at 0.01 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by dimethenamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://
www.epa.gov/fedrgstr/EPA-PEST/2004/September/Day-24/p21501.htm.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at https://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for dimethenamid used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of September 24, 2004 (69 FR 57197)
(FRL-7680-1).
[[Page 49352]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.464) for the residues of dimethenamid in or on
a variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from chemical name in food
as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one-day or single exposure.
The Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID\TM\, Version 1.3) which
incorporates food consumption data as reported by respondents in the
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the acute exposure
assessments: one hundred percent of proposed and registered crops are
treated with dimethenamid (100% CT) and tolerance-level residues for
all commodities.
ii. Chronic exposure.
In conducting the chronic dietary exposure assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\, Version 1.3) which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the chronic exposure
assessments: one hundred percent of proposed and registered crops are
treated with dimethenamid (100% CT) and tolerance-level residues for
all commodities
iii. Cancer. Dimethenamid (50:50 S:R isomers) was classified as a
group <https://www.epa.gov/oppefed1/models/water/
index.htm.
Based on the PRZM/EXAMS and SCI-GROW models, the estimated
environmental concentrations (EECs) of dimethenamid for acute exposures
are estimated to be 49 parts per billion (ppb) for surface water and
0.42 ppb for ground water. The EECs for chronic exposures are estimated
to be 7.9 ppb for surface water and 0.42 ppb for ground water.Modeled
estimates of drinking water concentrations were directly entered into
the dietary exposure model (DEEM-FCID\TM\, Version 1.3). For acute
dietary risk assessment, the peak water concentration value of 49 ppb
was used to access the contribution to drinking water. For chronic
dietary risk assessment, the annual average concentration of 7.9 ppb
was used to access the contribution to drinking water
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Dimethenamid is not registered for use on any sites that would
result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to dimethenamid and any other
substances and dimethenamid does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that dimethenamid has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at https://www.epa.gov/pesticides/
cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. No offspring pre- or
postnatal susceptibility to either dimethenamid (50:50 S:R isomers) or
dimethenamid-P (90:10 S:R isomers) was seen in a rabbit or two rat
developmental studies and reproduction study. There is low concern for
pre- or postnatal toxicity since the developmental effects from the
[[Page 49353]]
[S] and [RS] mixture are similar and occur at similar doses.
3. Conclusion. There is a complete toxicity data base for
dimethenamid and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures.
EPA determined that the safety factor for dimethenamid should be
100 (10X safety factor for interspecies extrapolation and 10X for
intraspecies variation). The additional FQPA SF was removed taking into
account the low concerns and lack residual uncertainties with regard to
prenatal and postnatal toxicity and the completeness of the toxicity
and exposure data base.
E. Aggregate Risks and Determination of Safety
The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against estimated drinking water
concentrations (EDWCs). The DWLOC values are not regulatory standards
for drinking water, but are theoretical upper limits on a pesticide's
concentration in drinking water in light of total aggregate exposure to
a pesticide in food and residential uses. More information on the use
of DWLOCs in dietary aggregate risk assessments can be found at https://
www.epa.gov/oppfead1/trac/science/
screeningsop.pdfMore recently the Agency has used another
approach to estimate aggregate exposure through food, residential and
drinking water pathways. In this approach, modeled surface and ground
water EDWCs are directly incorporated into the dietary exposure
analysis, along with food. This provides a more realistic estimate of
exposure because actual body weights and water consumption from the
CSFII are used. The combined food and water exposures are then added to
estimated exposure from residential sources to calculate aggregate
risks. The resulting exposure and risk estimates are still considered
to be high end, due to the assumptions used in developing drinking
water modeling inputs.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to dimethenamid will occupy <1% of the aPAD for females 13 years and
older. Therefore, EPA does not expect the aggregate exposure to exceed
100% of the aPAD.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
dimethenamid food and water will utilize <1 % of the cPAD for the U.S.
population, 1.2 % of the cPAD for all infants < 1 year old, the
subpopulation at greatest exposure, and <1 % of the cPAD for children
1-2 years old. There are no residential uses for dimethenamid.
Therefore, EPA does not expect the aggregate exposure to exceed 100% of
the cPAD.
3. Short-term and Intermediate-term risk.
Short-term and Intermediate-term aggregate exposures take into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Dimethenamid is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
4. Aggregate cancer risk for U.S. population. The Agency considers
the chronic aggregate risk assessment, making use of the cPAD, to be
protective of any aggregate cancer risk. See Unit III.E.2.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to dimethenamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (AM-0884-0193-1) is available to
enforce the tolerance expression. AM-0884-0193-1 is a gas
chromatography (GC) method using an HP-1 or HP-5 column and mass
selective detection (MSD). The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or Mexican MRLs for dimethenamid in
or on the proposed commodities. Therefore, harmonization of tolerances
is not an issue.
V. Conclusion
Therefore, tolerance are established for residues of dimethenamid,
(R,S)-2-chloro-N-[(1-methyl-2-methoxy) ethyl]-N-(2,4-dimethylthien-3-
yl)-acetamide in or on the commodities onion, green at 0.01 ppm; leek
at 0.01 ppm; onion, Welsh at 0.01 ppm; and shallot, fresh leaves at
0.01 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this 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 final 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 under 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 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). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. 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
[[Page 49354]]
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 final 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 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 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 rule.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 7, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.464 is amended by alphabetically adding commodities to
the table in paragraph (a) to read as follows:
Sec. 180.464 Dimethenamid; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Leek 0.01
* * * * *
Onion, green 0.01
Onion, Welsh 0.01
* * * * *
Shallot, fresh leaves 0.01
* * * * *
------------------------------------------------------------------------
[FR Doc. E6-13660 Filed 8-22-06; 8:45 am]
BILLING CODE 6560-50-S