Trifloxystrobin; Pesticide Tolerance, 55313-55319 [06-8060]
Download as PDF
<![CDATA[
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations
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 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
Commodity
55313
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: September 12, 2006.
Lois Rossi,
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 180.511 is amended by
alphabetically revising commodities and
adding cotton seed to the table in
paragraph (a) to read as follows:
I
§ 180.511
residues
(a) *
Buprofezin; tolerance for
*
*
Parts per million
Expiration/revocation
dates
*
*
*
*
*
Almond hulls ......................................................................................................................................
2.0
None
*
*
*
*
*
Cotton, gin byproducts .......................................................................................................................
20.0
None
Cotton seed .......................................................................................................................................
0.35
None
*
*
*
*
*
Tomato ...............................................................................................................................................
*
*
*
*
*
0.40
None
*
*
*
*
*
[FR Doc. 06–8065 Filed 9–21–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
rwilkins on PROD1PC63 with RULES_1
[EPA–HQ–OPP–2005–0299; FRL–8093–8]
Trifloxystrobin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
Final rule.
VerDate Aug<31>2005
16:03 Sep 21, 2006
Jkt 208001
SUMMARY: This regulation establishes
tolerances for combined residues of
Trifoxystrobin (Benzeneacetic acid,
(E,E)-a-(methoxyimino)-2-[[[[1-[3(trifluoromethyl)
phenyl]ethylidene]amino]oxy]methyl]-,
methyl ester and the free form of its acid
metabolite CGA-321113 ((E,E)methoxyimino-(2-[1-(3trifluoromethylphenyl)
ethylideneaminooxymethyl]
phenyl)acetic acid)) in or on soybean,
forage at 10.0 parts per million (ppm),
soybean, hay at 25.0 ppm, and soybean,
seed at 0.08 ppm. Bayer CropScience
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
PO 00000
Frm 00033
Fmt 4700
Sfmt 4700
(FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
This regulation is effective
September 22, 2006. Objections and
requests for hearings must be received
on or before November 21, 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).
DATES:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2005–0299. All documents in the
docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
ADDRESSES:
E:\FR\FM\22SER1.SGM
22SER1
55314
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations
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:
Janet Whitehurst, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6129; e-mail address:
janet.whitehurst@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
rwilkins on PROD1PC63 with RULES_1
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.
VerDate Aug<31>2005
16:03 Sep 21, 2006
Jkt 208001
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
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–2005–0299 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 November 21, 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–2005–0299, 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
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
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 January 4,
2006 (71 FR 340) (FRL–7750–6), 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 5F6956) by Bayer
CropScience, P.O. Box 12014, 2 T.W.
Alexander Drive, Research Triangle
Park, NC 27709. The petition requested
that 40 CFR 180.555 be amended by
establishing tolerances for combined
residues of the fungicide trifloxystrobin,
(Benzeneacetic acid, (E,E)-a(methoxyimino)-2-[[[[1-[3(trifluoromethyl)
phenyl]ethylidene]amino]oxy]methyl]-,
methyl ester and the free form of its acid
metabolite CGA-321113 ((E,E)methoxyimino-(2-[1-(3trifluoromethylphenyl)
ethylideneaminooxymethyl)phenyl)
acetic acid)) in or on soybean, forage at
8.0 ppm, soybean, hay at 20.0 ppm, and
soybean, seed at 0.08 ppm. That notice
included a summary of the petition
prepared by BayerCropScience, the
registrant. The petition also proposed a
4.2 ppm tolerance for aspirated grain
fractions (AGF) derived from soybean
seed. However, this tolerance is not
necessary as residues in/on soybean
AGF are covered by the existing 5.0
ppm tolerance or AGF, which was
established in conjunction with the use
of trifloxystrobin on wheat. 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
E:\FR\FM\22SER1.SGM
22SER1
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations
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/EPAPEST/1997/November/Day-26/
p30948.htm
https://www.epa.gov/oppfead1/trac/
science
https://www.epa.gov/pesticides/
factsheets/ riskassess.htm
https://www.epa.gov/pesticides/trac/
science/ aggregate.pdf.
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 combined
residues of trifloxystrobin and CGA
321113 on soybean, forage at 10.0 ppm,
soybean, hay at 25.0 ppm, and soybean,
seed at 0.08 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
trifloxystrobin as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found in the Federal Register of
March 29, 2006 (71 FR 15597) (FRL–
7759–9).
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which the NOAEL from
the toxicology study identified as
appropriate for use in risk assessment is
used to estimate the toxicological level
55315
of concern (LOC). However, the LOAEL
of concern identified 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 either of the
following websites:
https://www.epa.gov/pesticides/
factsheets/riskassess. htm;
https://www.epa.gov/oppfead1/trac/
science.
A summary of the toxicological
endpoints for trifloxystrobin human risk
assessment is shown in the following
Table 1:
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FOR USE IN HUMAN RISK ASSESSMENT
Exposure Scenario
Dose Used in Risk Assessment, UF
FQPA SF and Level of
Concern for Risk Assessment
NOAEL = 250 mg/kg/day
UF = 100
Acute RfD = 2.5 mg/kg/day
Acute dietary
General Population including infants and children. There were no appropriate toxicological effects attributable to a single exposure (dose) observed in oral toxicity studies including maternal effects in developmental studies in rats and rabbits. Therefore, a dose and endpoint were not identified for this risk assessment.
Chronic dietary (all populations)
Parental NOAEL= 3.8 mg/
kg/day
UF = 100
Chronic RfD = 0.038 mg/
kg/day
FQPA SF = 1X
cPAD = cRfD
FQPA SF= 0.038 mg/kg/
day
Two-generation reproduction study - rat
LOAEL = 55.3 mg/kg/day, based upon decreases in body weight, body weight gains,
reduced
food
consumption
and
histopathological lesions in the liver, kidneys
and spleen.
Short-term (1-30 days) and
intermed-term (1-6 months)
oral
Offspring NOAEL= 3.8 mg/
kg/day
LOC for MOE = 100 (residential, includes the
FQPA SF)
Two-Generation reproduction study - rat
LOAEL = 55.3 mg/kg/day, based upon reduced
pup body weights during lactation
Short-term (1-30 days) and
intermed-term (1-6 months)
dermal
rwilkins on PROD1PC63 with RULES_1
Acute dietary (female 13-49
only)
Dermal study NOAEL =
100 mg/kg/day
LOC for MOE = 100 (occupational)
LOC for MOE = 100 (residential, includes the
FQPA SF)
28-Day dermal toxicity study - rat
LOAEL = 1,000 mg/kg/day, based upon increases in mean absolute and relative liver
and kidney weights
Long-term dermal (>6 months)
Oral study NOAEL= 3.8
mg/kg/day (dermal absorption rate = 33%)
LOC for MOE = 100 (occupational)
LOC for MOE = 100 (residential, includes the
FQPA SF)
Two-generation reproduction study - rat
LOAEL = 55.3 mg/kg/day, based upon decreases in body weight, body weight gains,
reduced
food
consumption
and
histopathological lesions in the liver, kidneys
and spleen
VerDate Aug<31>2005
16:03 Sep 21, 2006
Jkt 208001
PO 00000
Frm 00035
FQPA SF = 1X
aPAD = aRfD
FQPA SF= 2.5 mg/kg/day
Study and Toxicological Effects
Fmt 4700
Sfmt 4700
Developmental toxicity - rat
LOAEL = 500 mg/kg/day, based upon increased fetal skeletal anomalies.
E:\FR\FM\22SER1.SGM
22SER1
55316
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FOR USE IN HUMAN RISK ASSESSMENT—Continued
Dose Used in Risk Assessment, UF
Exposure Scenario
Short-term (1-30 days),
intermed-term (1-6 months)
and long-term >6 months) inhalation
Oral study NOAEL= 3.8
mg/kg/day
(Inhalation absorption rate
= 100%)
Cancer (oral, dermal, inhalation)
FQPA SF and Level of
Concern for Risk Assessment
Study and Toxicological Effects
LOC for MOE = 100 (occupational)
LOC for MOE = 100 (residential, includes the
FQPA SF)
Two-generation reproduction study - rat
LOAEL = 55.3 mg/kg/day, based upon decreases in body weight, body weight gains,
reduced
food
consumption
and
histopathological lesions in the liver, kidneys
and spleen
Trifloxystrobin is classified as ‘‘Not Likely Human Carcinogen’’ based on the lack of evidence of carcinogenicity in mouse and rat cancer studies
rwilkins on PROD1PC63 with RULES_1
1 UF = uncertainty factor, FQPA SF = Special FQPA SF, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect
level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.555) for the
combined residues of trifloxystrobin
and CGA 321113 in or on a variety of
raw agricultural commodities. Risk
assessments were conducted by EPA to
assess dietary exposures from
trifloxystrobin 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 1–day or single
exposure.
In conducting the acute dietary
exposure assessment EPA used the
Dietary Exposure Evaluation Model
software with the Food Commodity
Intake Database (DEEM-FCIDTM), 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: The acute dietary exposure
analysis for trifloxystrobin is a Tier 1
assessment (assuming 100 percent crop
treated (%CT) and tolerance level
residues). The acute dietary endpoint
was found to be applicable only to the
population subgroup females 13-49
years old. An acute dietary endpoint for
the general population including infants
and children was not identified.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the DEEM-FCIDTM, which
incorporates food consumption data as
reported by respondents in the USDA
1994–1996 and 1998 Nationwide CSFII,
and accumulated exposure to the
chemical for each commodity. The
following assumptions were made for
the chronic exposure assessments: A
conservative chronic dietary analysis for
VerDate Aug<31>2005
16:03 Sep 21, 2006
Jkt 208001
trifloxystrobin was conducted using
tolerance-level residues for all
commodities with existing and
proposed tolerances except for meat
byproducts of cattle, goats, horses, and
sheep because the metabolite L7a (the
taurine conjugate of trifloxystrobin) is
included in the risk assessment for liver.
For all commodities, 100% CT was
used.
iii. Cancer. Trifloxystrobin is
classified as a ‘‘Not Likely Human
Carcinogen.’’ Due to the classification,
no cancer risk assessment was
performed.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
trifloxystrobin 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
trifloxystrobin. 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. EPA
determined estimated drinking water
concentrations (EDWCs) of
trifloxystrobin using the PRZM/EXAMS,
FIRST and SCI-GROW models. The
highest EDWCs for surface water and
ground water acute exposure (92 parts
per billion (ppb)) and surface water and
ground water chronic exposure (140
ppb) were used in the dietary analysis.
The chronic exposure value is higher
than the acute exposure value due to
some very conservative assumptions in
the chronic assessment. These estimates
of residues in drinking water were
incorporated directly into the DEEMFCID model of the dietary risk
assessment.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
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).
Trifloxystrobin is currently registered
for use on the following residential nondietary sites: Turfgrass and ornamentals.
The risk assessment was conducted
using the following residential exposure
assumptions: Trifloxystrobin is
currently registered for residential uses
including disease control in turfgrass
and ornamentals. Up to three
applications may be made in a season,
with the shortest interval between
applications being 5-7 days. Because
FQPA requires consideration of
aggregate exposure to all likely nonoccupational uses, this assessment uses
non-occupational post-application
contact with trifloxystrobin following
use on turfgrass as the most common
and worst case contributor to such
exposures.There is potential for dermal
(adults and children) and incidental oral
exposure (children only) during postapplication activities. The following
post-application exposure scenarios
resulting from lawn treatment were
assessed: i. Dermal exposure from
pesticide residues on lawns, ii.
incidental non-dietary ingestion of
pesticide residues on lawns from handto-mouth transfer, iii. incidental nondietary ingestion of residues from
object-to-mouth activities (pesticidetreated turfgrass), and iv. incidental
non-dietary ingestion of soil from
pesticide-treated residential areas. Postapplication exposures from various
activities following lawn treatment are
considered to be the most common and
significant in residential settings. The
exposure via incidental non-dietary
ingestion involving other plant material
may occur but is considered negligible.
Intermediate and chronic, or long-term
exposures are not expected.
4. Cumulative effects from substances
with a common mechanism of toxicity.
E:\FR\FM\22SER1.SGM
22SER1
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations
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
trifloxystrobin and any other substances
and trifloxystrobin 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 trifloxystrobin 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.
rwilkins on PROD1PC63 with RULES_1
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 margin of exposure (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 UFs and/or special
FQPA safety factors, as appropriate.
2. Conclusion. The Agency found that
because the toxicology database are
complete for FQPA purposes and that
there are no residual uncertainties for
prenatal/postnatal toxicity, the 10X
FQPA Safety Factor (SF) can be reduced
VerDate Aug<31>2005
16:03 Sep 21, 2006
Jkt 208001
to 1x. The FQPA SF is reduced to 1X
because:
• There is no indication of increased
susceptibility of rat or rabbits to
trifloxystrobin. In the developmental
and reproduction toxicity studies,
effects in the fetuses/offspring were
observed only at or above treatment
levels which resulted in evidence of
parental toxicity;
• The EPA determined that a
developmental neurotoxicity study in
rats is not required;
• The acute and chronic dietary food
exposure assessments utilize existing
and proposed tolerance level residues
and 100% CT information for all
commodities. By using these screeninglevel assessments, actual exposures/
risks will not be underestimated;
• The exposure assessments will not
underestimate the potential dietary
(food and drinking water) or non-dietary
exposures for infants and children from
the use of trifloxystrobin;
• The dietary drinking water
assessment utilizes water concentration
values generated by model and
associated modeling parameters, which
are designed to provide conservative,
health protective, high-end estimates of
water concentrations, which are not
likely to be exceeded; and
• The residential postapplication
assessment is based upon using
residential standard operating
procedures (SOPs). The assessment is
based upon surrogate study data. These
data are reliable and are not expected to
underestimate risk to adults or children.
The residential SOPs are based upon
reasonable ‘‘worst-case’’ assumptions
and are not expected to underestimate
risk.
E. Aggregate Risks and Determination of
Safety
1. Acute risk. The aggregate acute risk
estimates include exposure to residues
of trifloxystrobin in food and drinking
water, and does not include dermal,
inhalation or incidental oral exposure.
Since the dietary exposure assessment
already includes the highest acute
exposure from the drinking water
modeling data, no further calculations
are necessary. The food and drinking
water exposure estimates for females 1349 years old is <1% acute population
adjusted dose (aPAD). The acute risk
estimate for females 13-49 years,
resulting from aggregate exposure to
trifloxystrobin in food and drinking
water is below EPA’s level of concern.
2. Chronic risk. The aggregate chronic
risk assessment takes into account
average exposure estimates from dietary
consumption of trifloxystrobin (food
and drinking water) and residential
PO 00000
Frm 00037
Fmt 4700
Sfmt 4700
55317
uses. Since the exposure from turf is
considered short-term, the aggregate
chronic assessment included food and
drinking water only. Since the dietary
exposure assessment already includes
the highest chronic exposure from the
drinking water modeling data, no
further calculations are necessary. The
general U.S. population and all
population subgroups have exposure
and risk estimates which are below
EPA’s level of concern (i.e., the
percentages of the (cPADs are all below
100%). The exposure to the U.S.
population was 21% of the cPAD and
the most highly exposed subgroup,
cildren 1-2 years old, was at 62% of the
cPAD. Therefore, chronic risk estimates
resulting from aggregate exposure to
trifloxystrobin in food and drinking
water are below EPA’s level of concern
from all population subgroups.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level). The
short-term aggregate risk assessment
estimates risks likely to result from 1–
30 day exposure to trifloxystrobin
residues from food, drinking water, and
residential pesticide uses. High-end
estimates of residential exposure are
used in the short-term assessment,
while average values are used for food
and drinking water exposure (i.e.
chronic exposures).
Different endpoints were identified by
EPA for short-term incidental oral and
dermal risk assessment (the basis for the
oral endpoint is reduced pup body
weights and the dermal endpoint is
based on increases in liver and kidney
weights). Therefore, it is not reasonable,
as a toxicological matter, to combine
dietary/incidental oral exposure with
dermal exposure. A short-term aggregate
risk assessment for dietary plus
incidental oral exposure is needed for
toddlers because there are residential
postapplication incidental oral exposure
scenarios. Toddlers’ incidental oral
exposure is assumed to include hand-tomouth exposure, object-to-mouth
exposure and exposure through
incidental ingestion of soil. Because
toddlers also have post-application
dermal exposure as a result of the
residential use and because it is not
scientifically appropriate to combine
oral and dermal exposures for
trifloxystrobin, a separate short-term
aggregate risk assessment is needed for
toddlers to assess the risk of dermal
exposure. This separate risk assessment
only takes into account dermal exposure
and compares this exposure to the
dermal endpoint. The short-term
aggregate oral exposure to all other
E:\FR\FM\22SER1.SGM
22SER1
55318
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations
population groups is from dietary
exposure alone (i.e. from food and
drinking water) because these
population groups do not have
incidental oral exposures. As with
toddlers, a separate short-term aggregate
risk assessment has been conducted for
dermal exposure. Table 2 summarizes
short-term aggregate risks. All shortterm aggregate risk estimates result is
MOEs greater than 100. Therefore, EPA
does not consider short-term aggregate
risk to be a concern.
TABLE 2.—SHORT-TERM AGGREGATE RISK (FOOD, DRINKING WATER AND RESIDENTIAL EXPOSURE)
Short-Term Scenario
LOC MOE1
Average
Food +
Water Exposure mg/kg/
day
Oral Residential Exposure2 mg/
kg/day
Dermal
Residential
Exposure
mg/kg/day
3.8
100
0.008145
NA
NA
470
U.S. population/adults dermal
100
100
NA
NA
0.079
1300
Youth (13-19 years old)
3.8
100
0.005969
NA
NA
640
Children (1-2 years old) oral
3.8
100
0.023704
0.00642
NA
130
Children (1-2 years old) dermal
100
100
NA
NA
0.130
770
Females (13-49 years old)
3.8
100
0.006396
NA
NA
590
Population
NOAEL mg/
kg/day
U.S. population/adults oral
1
2
3
The LOC MOE is 100, based on inter-species and intra-species safety factors totaling 100.
Oral Residential Exposure = Incidental Oral exposure from all possible sources.
Aggregate MOE = NOAEL ÷ (All exposures appropriate to the assessment).
4. Intermediate-term risk. An
intermediate-term aggregate risk
assessment (1 to 6 months of exposure
to trifloxystrobin residues from food,
drinking water, and residential pesticide
uses) is not expected to occur based on
the short soil half-life (about 2 days).
Therefore, an intermediate-term
aggregate risk assessment was not
performed.
5. Aggregate cancer risk for U.S.
population. EPA determined that
trifloxystrobin should be classified as a
‘‘Not Likely Human Carcinogen.’’ EPA
does not expect trifloxystrobin to pose
a cancer risk.
6. 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
trifloxystrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
rwilkins on PROD1PC63 with RULES_1
Aggregate
MOE3
An adequate Gas Liquid
Chromatography/Nitrogen Phosphorous
(GC/NPD) method, Method AG-659A, is
available for enforcing tolerances for the
combined residues of trifloxystrobin
and the free form of its acid metabolite
(CGA-321113) in plant and livestock
commodities. This method was
validated by the and forwarded to FDA
for inclusion in PAM Vol. II.
In the current soybean field trials and
processing study, residues of
trifloxystrobin and CGA-321113 were
VerDate Aug<31>2005
16:03 Sep 21, 2006
Jkt 208001
determined using a LC/MS/MS method
(Bayer Report No. 200177), which was
previously developed for the analysis of
residues in tomatoes and peppers. This
method uses the same extraction
procedures as the current tolerance
enforcement method, but uses different
clean up procedures and detection by
LC/MS/MS. This method is adequate for
collecting residue data on
trifloxystrobin and CGA-321113 in
soybean commodities.
B. International Residue Limits
There are currently no Codex,
Canadian, or Mexican MRL’s or
tolerances for trifloxystrobin on
soybeans. Therefore, international
harmonization is not an issue for this
petition.
V. Conclusion
Therefore, the tolerance is established
for combined residues of trifoxystrobin,
(Benzeneacetic acid, (E,E)-a(methoxyimino)-2-[[[[1-[3(trifluoromethyl) phenyl] ethylidene]
amino]oxy]methyl]-, methyl ester and
the free form of its acid metabolite CGA321113 ((E,E)-methoxyimino-(2-[1-(3trifluoromethylphenyl)
ethylideneaminooxymethyl)phenyl)
acetic acid)) in or on soybean, forage at
10.0 ppm, soybean, hay at 25.0 ppm,
and soybean, seed at 0.08 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
PO 00000
Frm 00038
Fmt 4700
Sfmt 4700
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
E:\FR\FM\22SER1.SGM
22SER1
rwilkins on PROD1PC63 with RULES_1
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations
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
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
VerDate Aug<31>2005
16:03 Sep 21, 2006
Jkt 208001
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: September 14, 2006.
Lois Rossi,
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 180.555 is amended by
alphabetically adding commodities to
the table in paragraph (a) to read as
follows:
I
§ 180.555
residues.
Trifloxystrobin; tolerances for
55319
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 300
[Docket ID No. EPA–HQ–SFUND–1994–
0009; FRL–8221–6]
National Oil and Hazardous
Substances Pollution Contingency
Plan; National Priorities List
Environmental Protection
Agency.
ACTION: Direct Final Notice of Deletion
of the Army Materials Technology
Laboratory Superfund Site from the
National Priorities List.
AGENCY:
SUMMARY: EPA Region 1 is publishing a
direct final notice of deletion of the
Army Materials Technology Laboratory
Superfund Site (Site), located in
Watertown, Massachusetts, from the
National Priorities List (NPL). The NPL,
promulgated pursuant to section 105 of
the Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA) of 1980, as amended, is
Appendix B of 40 CFR part 300, which
is the National Oil and Hazardous
Substances Pollution Contingency Plan
(NCP). EPA is publishing this direct
final notice of deletion with the
concurrence of the Commonwealth of
Massachusetts, through the Department
of Environmental Protection (MADEP),
because EPA determined that all
appropriate response actions under
CERCLA—other than operation and
maintenance and five-year reviews—
have been completed and further
remedial action pursuant to CERCLA is
not appropriate.
DATES: This direct final deletion will be
effective November 21, 2006 unless EPA
receives adverse comments by October
23, 2006. If adverse comments are
received, EPA will publish a timely
withdrawal of the direct final deletion
in the Federal Register informing the
public that the deletion will not take
effect.
Submit your comments,
identified by Docket ID No. EPA–HQ–
SFUND–1994–0009, by one of the
Parts per
following methods:
Commodity
million
• www.regulations.gov: Follow the
on-line instruction for submitting
*
*
*
*
*
comments.
• E-mail: keckler.kymberlee@epa.gov.
Soybean, forage .......................
10.0
• Fax: (617) 918–0385.
Soybean, hay ............................
25.0
• Mail: Kymberlee Keckler, Remedial
Soybean, seed ..........................
0.08
*
*
*
*
*
Project Manager, U.S. Environmental
Protection Agency, Region 1, 1 Congress
Street, Suite 1100 (HBT), Boston,
*
*
*
*
*
Massachusetts 02114–2023.
[FR Doc. 06–8060 Filed 9–21–06; 8:45 am]
• Hand delivery: 1 Congress Street,
BILLING CODE 6560–50–S
Suite 1100 (HBT), Boston,
ADDRESSES:
(a) * * *
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
E:\FR\FM\22SER1.SGM
22SER1
]]>Agencies
[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Rules and Regulations]
[Pages 55313-55319]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8060]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0299; FRL-8093-8]
Trifloxystrobin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for combined residues
of Trifoxystrobin (Benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-, methyl
ester and the free form of its acid metabolite CGA-321113 ((E,E)-
methoxyimino-(2-[1-(3-trifluoromethylphenyl) ethylideneaminooxymethyl]
phenyl)acetic acid)) in or on soybean, forage at 10.0 parts per million
(ppm), soybean, hay at 25.0 ppm, and soybean, seed at 0.08 ppm. Bayer
CropScience requested this tolerance 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 September 22, 2006. Objections and
requests for hearings must be received on or before November 21, 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-2005-0299. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly
[[Page 55314]]
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: Janet Whitehurst, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6129; e-mail address:
janet.whitehurst@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 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-2005-0299 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 November 21, 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-2005-0299, 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 January 4, 2006 (71 FR 340) (FRL-7750-
6), 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
5F6956) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
180.555 be amended by establishing tolerances for combined residues of
the fungicide trifloxystrobin, (Benzeneacetic acid, (E,E)-[alpha]-
(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)
phenyl]ethylidene]amino]oxy]methyl]-, methyl ester and the free form of
its acid metabolite CGA-321113 ((E,E)-methoxyimino-(2-[1-(3-
trifluoromethylphenyl) ethylideneaminooxymethyl)phenyl)acetic acid)) in
or on soybean, forage at 8.0 ppm, soybean, hay at 20.0 ppm, and
soybean, seed at 0.08 ppm. That notice included a summary of the
petition prepared by BayerCropScience, the registrant. The petition
also proposed a 4.2 ppm tolerance for aspirated grain fractions (AGF)
derived from soybean seed. However, this tolerance is not necessary as
residues in/on soybean AGF are covered by the existing 5.0 ppm
tolerance or AGF, which was established in conjunction with the use of
trifloxystrobin on wheat. 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
[[Page 55315]]
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
https://www.epa.gov/oppfead1/trac/science
https://www.epa.gov/pesticides/factsheets/riskassess.htm
https://www.epa.gov/pesticides/trac/science/aggregate.pdf.
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 combined residues of
trifloxystrobin and CGA 321113 on soybean, forage at 10.0 ppm, soybean,
hay at 25.0 ppm, and soybean, seed at 0.08 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 trifloxystrobin 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 in the
Federal Register of March 29, 2006 (71 FR 15597) (FRL-7759-9).
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which 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 LOAEL
of concern identified 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 either of the following websites:
https://www.epa.gov/pesticides/factsheets/riskassess. htm;
https://www.epa.gov/oppfead1/trac/science.
A summary of the toxicological endpoints for trifloxystrobin human
risk assessment is shown in the following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (female 13-49 only) NOAEL = 250 mg/kg/day FQPA SF = 1X Developmental toxicity
UF = 100............... aPAD = aRfD............ rat
Acute RfD = 2.5 mg/kg/ FQPA SF= 2.5 mg/kg/day. LOAEL = 500 mg/kg/day,
day. based upon increased
fetal skeletal
anomalies.
----------------------------------------------------------------------------------------------------------------
Acute dietary General Population including infants and children. There were no
appropriate toxicological effects attributable to a single exposure
(dose) observed in oral toxicity studies including maternal effects in
developmental studies in rats and rabbits. Therefore, a dose and
endpoint were not identified for this risk assessment.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations) Parental NOAEL= 3.8 mg/ FQPA SF = 1X Two-generation
kg/day cPAD = cRfD............ reproduction study -
UF = 100............... FQPA SF= 0.038 mg/kg/ rat
Chronic RfD = 0.038 mg/ day. LOAEL = 55.3 mg/kg/day,
kg/day. based upon decreases
in body weight, body
weight gains, reduced
food consumption and
histopathological
lesions in the liver,
kidneys and spleen.
----------------------------------------------------------------------------------------------------------------
Short-term (1-30 days) and intermed- Offspring NOAEL= 3.8 mg/ LOC for MOE = 100 Two-Generation
term (1-6 months) oral kg/day (residential, includes reproduction study -
the FQPA SF) rat
LOAEL = 55.3 mg/kg/day,
based upon reduced pup
body weights during
lactation
----------------------------------------------------------------------------------------------------------------
Short-term (1-30 days) and intermed- Dermal study NOAEL = LOC for MOE = 100 28-Day dermal toxicity
term (1-6 months) dermal 100 mg/kg/day (occupational) study - rat
LOC for MOE = 100 LOAEL = 1,000 mg/kg/
(residential, includes day, based upon
the FQPA SF). increases in mean
absolute and relative
liver and kidney
weights
----------------------------------------------------------------------------------------------------------------
Long-term dermal (>6 months) Oral study NOAEL= 3.8 LOC for MOE = 100 Two-generation
mg/kg/day (dermal (occupational) reproduction study -
absorption rate = 33%) LOC for MOE = 100 rat
(residential, includes LOAEL = 55.3 mg/kg/day,
the FQPA SF). based upon decreases
in body weight, body
weight gains, reduced
food consumption and
histopathological
lesions in the liver,
kidneys and spleen
----------------------------------------------------------------------------------------------------------------
[[Page 55316]]
Short-term (1-30 days), intermed-term Oral study NOAEL= 3.8 LOC for MOE = 100 Two-generation
(1-6 months) and long-term >6 mg/kg/day (occupational) reproduction study -
months) inhalation (Inhalation absorption LOC for MOE = 100 rat
rate = 100%). (residential, includes LOAEL = 55.3 mg/kg/day,
the FQPA SF). based upon decreases
in body weight, body
weight gains, reduced
food consumption and
histopathological
lesions in the liver,
kidneys and spleen
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Trifloxystrobin is classified as ``Not Likely Human Carcinogen'' based on
the lack of evidence of carcinogenicity in mouse and rat cancer studies
----------------------------------------------------------------------------------------------------------------
1 UF = uncertainty factor, FQPA SF = Special FQPA SF, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose,
MOE = margin of exposure, LOC = level of concern
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.555) for the combined residues of
trifloxystrobin and CGA 321113 in or on a variety of raw agricultural
commodities. Risk assessments were conducted by EPA to assess dietary
exposures from trifloxystrobin 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 1-day or single exposure.
In conducting the acute dietary exposure assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\), 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: The
acute dietary exposure analysis for trifloxystrobin is a Tier 1
assessment (assuming 100 percent crop treated (%CT) and tolerance level
residues). The acute dietary endpoint was found to be applicable only
to the population subgroup females 13-49 years old. An acute dietary
endpoint for the general population including infants and children was
not identified.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID\TM\, which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 Nationwide CSFII, and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: A conservative chronic dietary analysis for
trifloxystrobin was conducted using tolerance-level residues for all
commodities with existing and proposed tolerances except for meat
byproducts of cattle, goats, horses, and sheep because the metabolite
L7a (the taurine conjugate of trifloxystrobin) is included in the risk
assessment for liver. For all commodities, 100% CT was used.
iii. Cancer. Trifloxystrobin is classified as a ``Not Likely Human
Carcinogen.'' Due to the classification, no cancer risk assessment was
performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for trifloxystrobin 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 trifloxystrobin. 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. EPA
determined estimated drinking water concentrations (EDWCs) of
trifloxystrobin using the PRZM/EXAMS, FIRST and SCI-GROW models. The
highest EDWCs for surface water and ground water acute exposure (92
parts per billion (ppb)) and surface water and ground water chronic
exposure (140 ppb) were used in the dietary analysis. The chronic
exposure value is higher than the acute exposure value due to some very
conservative assumptions in the chronic assessment. These estimates of
residues in drinking water were incorporated directly into the DEEM-
FCID model of the dietary risk assessment.
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).
Trifloxystrobin is currently registered for use on the following
residential non-dietary sites: Turfgrass and ornamentals. The risk
assessment was conducted using the following residential exposure
assumptions: Trifloxystrobin is currently registered for residential
uses including disease control in turfgrass and ornamentals. Up to
three applications may be made in a season, with the shortest interval
between applications being 5-7 days. Because FQPA requires
consideration of aggregate exposure to all likely non-occupational
uses, this assessment uses non-occupational post-application contact
with trifloxystrobin following use on turfgrass as the most common and
worst case contributor to such exposures.There is potential for dermal
(adults and children) and incidental oral exposure (children only)
during post-application activities. The following post-application
exposure scenarios resulting from lawn treatment were assessed: i.
Dermal exposure from pesticide residues on lawns, ii. incidental non-
dietary ingestion of pesticide residues on lawns from hand-to-mouth
transfer, iii. incidental non-dietary ingestion of residues from
object-to-mouth activities (pesticide-treated turfgrass), and iv.
incidental non-dietary ingestion of soil from pesticide-treated
residential areas. Post-application exposures from various activities
following lawn treatment are considered to be the most common and
significant in residential settings. The exposure via incidental non-
dietary ingestion involving other plant material may occur but is
considered negligible. Intermediate and chronic, or long-term exposures
are not expected.
4. Cumulative effects from substances with a common mechanism of
toxicity.
[[Page 55317]]
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 trifloxystrobin and any
other substances and trifloxystrobin 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 trifloxystrobin
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
margin of exposure (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 UFs and/or special FQPA safety factors, as appropriate.
2. Conclusion. The Agency found that because the toxicology
database are complete for FQPA purposes and that there are no residual
uncertainties for prenatal/postnatal toxicity, the 10X FQPA Safety
Factor (SF) can be reduced to 1x. The FQPA SF is reduced to 1X because:
There is no indication of increased susceptibility of rat
or rabbits to trifloxystrobin. In the developmental and reproduction
toxicity studies, effects in the fetuses/offspring were observed only
at or above treatment levels which resulted in evidence of parental
toxicity;
The EPA determined that a developmental neurotoxicity
study in rats is not required;
The acute and chronic dietary food exposure assessments
utilize existing and proposed tolerance level residues and 100% CT
information for all commodities. By using these screening-level
assessments, actual exposures/risks will not be underestimated;
The exposure assessments will not underestimate the
potential dietary (food and drinking water) or non-dietary exposures
for infants and children from the use of trifloxystrobin;
The dietary drinking water assessment utilizes water
concentration values generated by model and associated modeling
parameters, which are designed to provide conservative, health
protective, high-end estimates of water concentrations, which are not
likely to be exceeded; and
The residential postapplication assessment is based upon
using residential standard operating procedures (SOPs). The assessment
is based upon surrogate study data. These data are reliable and are not
expected to underestimate risk to adults or children. The residential
SOPs are based upon reasonable ``worst-case'' assumptions and are not
expected to underestimate risk.
E. Aggregate Risks and Determination of Safety
1. Acute risk. The aggregate acute risk estimates include exposure
to residues of trifloxystrobin in food and drinking water, and does not
include dermal, inhalation or incidental oral exposure. Since the
dietary exposure assessment already includes the highest acute exposure
from the drinking water modeling data, no further calculations are
necessary. The food and drinking water exposure estimates for females
13-49 years old is <1% acute population adjusted dose (aPAD). The acute
risk estimate for females 13-49 years, resulting from aggregate
exposure to trifloxystrobin in food and drinking water is below EPA's
level of concern.
2. Chronic risk. The aggregate chronic risk assessment takes into
account average exposure estimates from dietary consumption of
trifloxystrobin (food and drinking water) and residential uses. Since
the exposure from turf is considered short-term, the aggregate chronic
assessment included food and drinking water only. Since the dietary
exposure assessment already includes the highest chronic exposure from
the drinking water modeling data, no further calculations are
necessary. The general U.S. population and all population subgroups
have exposure and risk estimates which are below EPA's level of concern
(i.e., the percentages of the (cPADs are all below 100%). The exposure
to the U.S. population was 21% of the cPAD and the most highly exposed
subgroup, cildren 1-2 years old, was at 62% of the cPAD. Therefore,
chronic risk estimates resulting from aggregate exposure to
trifloxystrobin in food and drinking water are below EPA's level of
concern from all population subgroups.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). The short-term
aggregate risk assessment estimates risks likely to result from 1-30
day exposure to trifloxystrobin residues from food, drinking water, and
residential pesticide uses. High-end estimates of residential exposure
are used in the short-term assessment, while average values are used
for food and drinking water exposure (i.e. chronic exposures).
Different endpoints were identified by EPA for short-term
incidental oral and dermal risk assessment (the basis for the oral
endpoint is reduced pup body weights and the dermal endpoint is based
on increases in liver and kidney weights). Therefore, it is not
reasonable, as a toxicological matter, to combine dietary/incidental
oral exposure with dermal exposure. A short-term aggregate risk
assessment for dietary plus incidental oral exposure is needed for
toddlers because there are residential postapplication incidental oral
exposure scenarios. Toddlers' incidental oral exposure is assumed to
include hand-to-mouth exposure, object-to-mouth exposure and exposure
through incidental ingestion of soil. Because toddlers also have post-
application dermal exposure as a result of the residential use and
because it is not scientifically appropriate to combine oral and dermal
exposures for trifloxystrobin, a separate short-term aggregate risk
assessment is needed for toddlers to assess the risk of dermal
exposure. This separate risk assessment only takes into account dermal
exposure and compares this exposure to the dermal endpoint. The short-
term aggregate oral exposure to all other
[[Page 55318]]
population groups is from dietary exposure alone (i.e. from food and
drinking water) because these population groups do not have incidental
oral exposures. As with toddlers, a separate short-term aggregate risk
assessment has been conducted for dermal exposure. Table 2 summarizes
short-term aggregate risks. All short-term aggregate risk estimates
result is MOEs greater than 100. Therefore, EPA does not consider
short-term aggregate risk to be a concern.
Table 2.--Short-Term Aggregate Risk (Food, Drinking Water and Residential Exposure)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Short-Term Scenario
-----------------------------------------------------------------------------
Average
Population Food + Oral Dermal
NOAEL mg/kg/ LOC MOE1 Water Residential Residential Aggregate
day Exposure mg/ Exposure2 Exposure mg/ MOE3
kg/day mg/kg/day kg/day
---------------------------------------------------------------------------------------------------------------------------------------------
U.S. population/adults oral 3.8 100 0.008145 NA NA 470
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population/adults dermal 100 100 NA NA 0.079 1300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth (13-19 years old) 3.8 100 0.005969 NA NA 640
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old) oral 3.8 100 0.023704 0.00642 NA 130
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old) dermal 100 100 NA NA 0.130 770
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 3.8 100 0.006396 NA NA 590
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 The LOC MOE is 100, based on inter-species and intra-species safety factors totaling 100.
2 Oral Residential Exposure = Incidental Oral exposure from all possible sources.
3 Aggregate MOE = NOAEL / (All exposures appropriate to the assessment).
4. Intermediate-term risk. An intermediate-term aggregate risk
assessment (1 to 6 months of exposure to trifloxystrobin residues from
food, drinking water, and residential pesticide uses) is not expected
to occur based on the short soil half-life (about 2 days). Therefore,
an intermediate-term aggregate risk assessment was not performed.
5. Aggregate cancer risk for U.S. population. EPA determined that
trifloxystrobin should be classified as a ``Not Likely Human
Carcinogen.'' EPA does not expect trifloxystrobin to pose a cancer
risk.
6. 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 trifloxystrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate Gas Liquid Chromatography/Nitrogen Phosphorous (GC/NPD)
method, Method AG-659A, is available for enforcing tolerances for the
combined residues of trifloxystrobin and the free form of its acid
metabolite (CGA-321113) in plant and livestock commodities. This method
was validated by the and forwarded to FDA for inclusion in PAM Vol. II.
In the current soybean field trials and processing study, residues
of trifloxystrobin and CGA-321113 were determined using a LC/MS/MS
method (Bayer Report No. 200177), which was previously developed for
the analysis of residues in tomatoes and peppers. This method uses the
same extraction procedures as the current tolerance enforcement method,
but uses different clean up procedures and detection by LC/MS/MS. This
method is adequate for collecting residue data on trifloxystrobin and
CGA-321113 in soybean commodities.
B. International Residue Limits
There are currently no Codex, Canadian, or Mexican MRL's or
tolerances for trifloxystrobin on soybeans. Therefore, international
harmonization is not an issue for this petition.
V. Conclusion
Therefore, the tolerance is established for combined residues of
trifoxystrobin, (Benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl] ethylidene] amino]oxy]methyl]-,
methyl ester and the free form of its acid metabolite CGA-321113
((E,E)-methoxyimino-(2-[1-(3-trifluoromethylphenyl)
ethylideneaminooxymethyl)phenyl)acetic acid)) in or on soybean, forage
at 10.0 ppm, soybean, hay at 25.0 ppm, and soybean, seed at 0.08 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
[[Page 55319]]
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 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: September 14, 2006.
Lois Rossi,
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 180.555 is amended by alphabetically adding commodities to
the table in paragraph (a) to read as follows:
Sec. 180.555 Trifloxystrobin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Soybean, forage............................................ 10.0
Soybean, hay............................................... 25.0
Soybean, seed.............................................. 0.08
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 06-8060 Filed 9-21-06; 8:45 am]
BILLING CODE 6560-50-S
