[Federal Register: April 8, 2005 (Volume 70, Number 67)]
[Rules and Regulations]
[Page 17901-17908]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap05-4]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0412; FRL-7691-8]
Buprofezin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
buprofezin in or on avocado, papaya, star apple, black sapote, mango,
sapodilla, canistel, mamey sapote, sugar apple, cherimoya, atemoya,
custard apple, ilama, soursop, birida, guava, feijoa, jaboticaba, wax
jambu, starfruit, passionfruit, and acerola at 0.30 parts per million
(ppm); pome fruit at 0.30 ppm; peach at 9.0 ppm, meat (cattle, goat,
hog, horse, and sheep) at 0.05 ppm; kidney (cattle, goat, hog, horse,
and sheep) at 0.05 ppm.; lettuce, head at 5.0 ppm, Lettuce, leaf at
13.0 ppm, and Vegetable, cucurbit at 0.5 ppm; fruit, citrus, group 10
at 2.5 ppm; citrus, dried, pulp at 7.5 ppm; and citrus, oil at 80 ppm.
Nichino America, Inc., Linden Park, Suite 501, 4550 New Linden Hill
Road, Wilmington, DE 19808 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 April 8, 2005. Objections and
requests for hearings must be received on or before June 7, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2004-0412. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
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 electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S.
Bell St., Arlington, VA. This 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: Richard J. Gebken, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6701; e-mail address:
gebken.richard@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 and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of March 17, 2004 (69 FR 12676) (FRL-7347-
1), EPA issued a notice pursuant to section
[[Page 17902]]
408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a
pesticide petition (PP 3E6636, 3E6741, and 3E6747) by Interregional
Research Project Number (IR-4), 681 U.S. Highway 1 South,
North Brunswick, NJ 08902 and Nichino America, Inc., Linden Park, Suite
501, 4550 New Linden Hill Road, Wilmington, DE 19808. The petition
requested that 40 CFR 180.511 be amended by establishing a tolerance
for residues of the insecticide buprofezin (2-[(1,1-
dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4H-1,3,5-
thiadiazin-4-one), in or on the raw agricultural commodities: Fruit,
pome, group 11, except apple and apple, pomace at 4.0 parts per million
(ppm) (PP 3E6636), apple at 1.2 ppm (PP 3E6636), apple, pomace at 2.5
ppm (PP 3E6636), peach, apricot, and nectarine at 3.0 ppm (PP 3E6741),
and avocado, papaya, star apple, black sapote, mango, sapodilla,
canistel, mamey sapote, sugar apple, cherimoya, atemoya, custard apple,
ilama, soursop, biriba, guava, feijoa, jaboticaba, wax jambu,
starfruit, passionfruit, and acerola at 0.30 ppm (PP 3E6747).
In the Federal Register of June 21, 2000 (65 FR 38543) (FRL-6557-
3), 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
0F6087) by Nichino America, Inc., Linden Park, Suite 501, 4550 New
Linden Hill Road, Wilmington, DE 19808, (formerly Aventis CropScience,
formerly AgrEvo USA Company). The petition requested that 40 CFR
180.511 be amended by establishing a tolerance for residues of the
insecticide buprofezin] (2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-
methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one), in or on the
following meat commodities; (Cattle, goats, hogs, horse, and sheep at
0.05 ppm) and kidney commodities for (cattle, goats, hogs, horse, and
sheep at 0.05 ppm) respectively.
In the Federal Register of December 22, 2004 (69 FR 76719) (FRL-
7689-4), 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
4F6873) by Nichino America, Inc., Linden Park, Suite 501, 4550 New
Linden Hill Road, Wilmington, DE 19808. The petition requested that 40
CFR 180.511 be amended by establishing increased tolerances for
residues of buprofezin (2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-
methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one) in or on the following
agricultural commodities: Fruit, citrus, Group 10 at 2.5 ppm); citrus,
dried pulp at 7.5 ppm; and citrus, oil at 80 ppm.
In the Federal Register of December 23, 2004 (69 FR 76942) (FRL-
7694-1), 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
4F6887) by Nichino America, Inc., Linden Park, Suite 501, 4550 New
Linden Hill Road, Wilmington, DE 19808. The petition requested that 40
CFR 180.511 be amended by establishing tolerances for residues of
buprofezin (2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-
phenyl-4H-1,3,5-thiadiazin-4-one) in or on the following raw
agricultural commodities: Head lettuce at 5 ppm, leaf lettuce at 13
ppm, and Vegetables, cucurbits, group 9 at 0.5 ppm.
Each respective notice included a summary of the petition prepared
by the registrant Nichino America, Incorporated, 4550 New Linden Hill
Road, Suite 501, Wilmington, DE 19808, or the previous, registrant
Aventis CropScience.
A private citizen responded to petitions PP 3E6636, 3E6741, 3E6747,
4F6873, and 4F6887. The substantive public comments and corresponding
Agency responses are addressed in a separate document available in the
docket for this action under Docket identification (ID) number OPP-
2004-0362.
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 FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
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 buprofezin in or on
avocado, papaya, star apple, black sapote, mango, sapodilla, canistel,
mamey sapote, sugar apple, cherimoya, atemoya, custard apple, ilama,
soursop, birida, guava, feijoa, jaboticaba, wax jambu, starfruit,
passionfruit, and acerola at 0.30 parts per million (ppm); pome fruit
at 4.0 ppm; peach at 9.0 ppm, meat (cattle, goat, hog, horse, and
sheep) at 0.05 ppm; kidney (cattle, goat, hog, horse, and sheep) at
0.05 ppm; Lettuce, head at 5.0 ppm, Lettuce, leaf at 13 ppm; Vegetable,
cucurbit group 9 at 0.50 ppm; Fruit, citrus, Group 10 at 2.5 parts per
million (ppm); Citrus, dried pulp at 7.5 ppm, and citrus, oil at 80
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. The nature of the toxic effects caused by buprofezin as well
as the no observed adverse effect level (NOAEL) and the lowest observed
adverse effect level (LOAEL) from the toxicity studies reviewed are
discussed in the Federal Register of June 25, 2003 (68 FR 37765) (FRL-
7310-7).
B. Toxicological Endpoints
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
[[Page 17903]]
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors;'' the ``special FQPA safety
factor;'' and the ``default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors have
been incorporated by the FQPA into the additional safety factor for the
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary for
the protection of infants and children primarily as a result of the
FQPA. The ``default FQPA safety factor'' is the additional 10X safety
factor that is mandated by the statute unless it is decided that there
are reliable data to choose a different additional factor (potentially
a traditional uncertainty factor or a special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of
100 to account for interspecies and intraspecies differences and any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor is
used, this additional factor is applied to the RfD by dividing the RfD
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 X
10-5), one in a million (1 X 10-6), or one in ten
million (1 X 10-7). Under certain specific circumstances,
MOE calculations will be used for the carcinogenic risk assessment. In
this non-linear approach, a ``point of departure'' is identified below
which carcinogenic effects are not expected. The point of departure is
typically a NOAEL based on an endpoint related to cancer effects though
it may be a different value derived from the dose response curve. To
estimate risk, a ratio of the point of departure to exposure
(MOEcancer = point of departure/exposures) is calculated.
A summary of the toxicological endpoints for buprofezin used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of June 25, 2003 (68 FR 37765) (FRL-
7310-7).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.511) for the residues of buprofezin, in or on a
variety of raw agricultural commodities. Tolerances for residues of
buprofezin are currently established for ruminant fat, meat byproducts,
and liver at 0.05 ppm (40 CFR 180.511). Tolerances are being
established for meat (cattle, goat, hog, horse, and sheep) at 0.05 ppm;
and kidney (cattle, goat, hog, horse, and sheep) at 0.05 ppm; based on
additional animal metabolism studies provided from Nichino America,
Inc. Risk assessments were conducted by EPA to assess dietary exposures
from buprofezin in food as follows:
i. Acute and chronic exposure. Acute dietary 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 risk assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\) (ver. 1.30) and Lifeline\TM\ (ver.
2.00) models, 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 analysis assumed
tolerance level residues, 100% crop treated for all uses, and DEEM\TM\
(ver. 7.76) default processing factors for all registered/proposed
commodities (Tier 1). The chronic analysis assumed DEEM\TM\ (ver.7.76)
default processing factors for all registered/proposed commodities and
incorporated percent crop treated estimates and average field trial
residues.
ii. Cancer. In accordance with the EPA Guidelines for Carcinogen
Risk Assessment, the Carcinogen Assessment Review Commission classified
buprofezin as having ``suggestive evidence of carcinogenicity, but not
sufficient to assess human carcinogenic potential'' based on liver
tumors in female mice. The Committee further recommended no
quantification of cancer risk.
iii. Anticipated residue and percent crop treated (PCT)
information. Section 408(b)(2)(F) of FFDCA states that the Agency may
use data on the actual percent of food treated for assessing chronic
dietary risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid basis
to show what percentage of the food derived from such crop is likely to
contain such pesticide residue; Condition 2, that the exposure estimate
does not underestimate exposure for any significant subpopulation
group; and Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
The Agency used PCT information as follows:
5% crop treated (PCT) for cantaloupes;
2.5% crop treated for cotton, grapefruit, grapes, lemons,
limes, oranges, squash, tangelos, tangerines, tomatoes, and watermelon;
Market share % crop treated was projected not to exceed 5%
for apples, and 13% for peaches;
All other crops currently registered and/or proposed
commodities were assumed to be 100% crop treated.
The Agency believes that the three conditions listed in Unit C. 1.
iii. have been met. With respect to Condition 1, PCT estimates are
derived from Federal and private market survey data, which are reliable
and have a valid basis. For previously registered crops, EPA used an
average of the values from these surveys over the last 5 years for
estimating PCT for chronic dietary
[[Page 17904]]
exposure assessments. For most newly registered crops, the Agency
assumed 100% PCT. In estimating PCT for the apples and peaches as
newly-registered crops, EPA assumed that the PCT for buprofezin would
at least equal or exceed the PCT for the leading comparable insect
growth regulatory pesticide alternative on that crop. For peaches, PCT
for buprofezin was projected to potentially exceed the leading
alternative's PCT by a factor of five because buprofezin has a slight
cost advantage over the alternative on that crop. With regards to
apples, buprofezin was projected to slightly exceed sales of the
leading alternative's PCT because buprofezin is an excellent technical
fit as an insect pest management (IPM) insecticide for apples. The
Agency is reasonably certain that the percentage of the food treated is
not likely to be an underestimation.
As to Conditions 2 and 3, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which buprofezin may
be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for buprofezin 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 buprofezin.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) to estimate pesticide concentrations in surface
water and Screening Concentrations in Groundwater (SCI-GROW), which
predicts pesticide concentrations in ground water. In general, EPA will
use GENEEC (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model)
for a screening-level assessment for surface water. The GENEEC model is
a subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. GENEEC incorporates a farm pond scenario,
while PRZM/EXAMS incorporate an index reservoir environment in place of
the previous pond scenario. The PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Since DWLOCs address total aggregate exposure to buprofezin they are
further discussed in the aggregate risk sections in Unit E.
Based on the GENEEC, PRZM/EXAMS and SCI-GROW models, the EECs of
buprofezin for acute exposures are estimated to be 19.2 parts per
billion (ppb) for surface water and 0.1 ppb for ground water. The EECs
for chronic exposures are estimated to be 4.5 ppb for surface water and
0.1 ppb for ground 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). Buprofezin 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 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 buprofezin and any other
substances and buprofezin 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 buprofezin 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 OPP concerning common mechanism
determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA's web site at http://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. The Agency concluded that
the available studies provided no indication of increased
susceptibility of rats or
[[Page 17905]]
rabbits following in utero exposure or of rats following prenatal/
postnatal exposure to buprofezin.
3. Conclusion. There is a complete toxicity data base for
buprofezin and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X SF to protect infants and children should be reduced to
1X.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs 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. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 Liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
buprofezin will occupy 5.0% of the aPAD for females 13 to 19 years old.
In addition, there is potential for acute dietary exposure to
buprofezin] in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface water and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the aPAD, as shown in
Table 1 of this unit:
Table 1.--Aggregate Risk Assessment for Acute Exposure to Buprofezin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 2.0 5 19.2 0.1 57,000
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, the chronic aggregate risk assessment takes
into account average exposure estimates from dietary consumption of
buprofezin (food and drinking water). However, there are no residential
uses for buprofezin that result in chronic residential exposure to
buprofezin. Therefore, the chronic aggregate risk assessment will
consider exposure from food and drinking water only. There is potential
for chronic dietary exposure to buprofezin in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface water and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in Table 2 of this unit:
Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Buprofezin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.01 38 4.5 0.1 220
---------------------------------------------------------------------------
All infants (< 1 yr old) 0.01 64 4.5 0.1 36
---------------------------------------------------------------------------
Children (1-2 years old) 0.01 81 4.5 0.1 19
---------------------------------------------------------------------------
Youth (13-19 years old) 0.01 32 4.5 0.1 200
---------------------------------------------------------------------------
Adults (50 years + old) 0.01 39 4.5 0.1 21
---------------------------------------------------------------------------
Females (13-49 years old) 0.01 34 4.5 0.1 200
----------------------------------------------------------------------------------------------------------------
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). Buprofezin 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. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure
[[Page 17906]]
plus chronic exposure to food and water (considered to be a background
exposure level). Buprofezin 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.
5. Aggregate cancer risk for U.S. population. In chronic studies in
the rat, an increased incidence of follicular cell hyperplasia and
hypertrophy in the thyroid of males was reported. Increased relative
liver weights were reported in female dogs. Buprofezin was not
carcinogenic to male and female rats. In the mouse, increased absolute
liver weights in males and females, along with an increased incidence
of hepatocellular adenomas and hepatocellular adenomas plus carcinomas
in females were reported. Buprofezin was negative in in vitro and in
vivo genotoxicity assays. The findings from the published literature
indicate that buprofezin causes cell transformation and induces
micronuclei in vitro. In the absence of a positive response in an in
vivo micronucleus assay, the Agency concluded that buprofezin may have
aneugenic potential, which is not expressed in vivo. In sum, buprofezin
was negative in the rat, negative for mutagenicity and negative for
male mice; however, in female mice, a slight or marginal increase in
combined adenomas and carcinomas was observed. Given these findings in
the cancer and mutagenicity studies, EPA regards the carcinogenic
potential of buprofezin as very low and concludes that it poses no
greater than a negligible cancer risk to humans.
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 buprofezin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Plants. Adequate enforcement methodology gas chromatography using
nitrogen phosphorus detection is available to enforce the tolerance
expression.
Livestock. The Agency has successfully validated method BF/11/97
for enforcement of the livestock tolerances and the method was
forwarded to FDA's Technical Editing Group for publication in a future
revision of the Pesticide Analytical Manual I (PAM I).
The methods 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 Canadian, Mexican, or Codex maximum residue limits
(MRLs) established for buprofezin in/on any of the commodities
associated with the current petition. Therefore, harmonization is not
relevant.
V. Conclusion
Therefore, the tolerance is established for residues of buprofezin,
in or on avocado, papaya, star apple, black sapote, mango, sapodilla,
canistel, mamey sapote, sugar apple, cherimoya, atemoya, custard apple,
ilama, soursop, birida, guava, feijoa, jaboticaba, wax jambu,
starfruit, passionfruit, and acerola] at 0.30 ppm; Fruit, Pome, Crop
Group 11 at 4.0 ppm; Peach at 9.0 ppm; Meat (cattle, goat, hog, horse,
and sheep) at 0.05 ppm; and Kidney (cattle, goat, hog, horse, and
sheep) at 0.05 ppm; Lettuce, head at 5.0 ppm; Lettuce, leaf at 13 ppm;
and Vegetable, cucurbit group 9 at 0.50 ppm; Fruit, citrus, Group 10 at
2.5 ppm; citrus, dried pulp at 7.5 ppm; and citrus, oil at 80 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days. A. What Do I
Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0412 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 June 7,
2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-0412, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy
[[Page 17907]]
of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. 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. The Agency hereby certifies that this rule will not
have significant negative economic impact on a substantial number of
small entities. 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.
VIII. 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: March 29, 2005.
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 180.511 is amended by revising the entries for ``Fruit,
citrus''; ``Lettuce, head''; ``Lettuce, leaf''; and ``Vegetable,
cucurbit'' and by alphabetically adding commodities in the table in
paragraph (a) to read as follows:
Sec. 180.511 Buprofezin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per Revocation
million Date
------------------------------------------------------------------------
Acerola....................................... 0.30 None
* * * * *
Atemoya....................................... 0.30 None
Avocado....................................... 0.30 None
* * * * *
Birida........................................ 0.30 None
Black sapote.................................. 0.30 None
Canistel...................................... 0.30 None
* * * * *
Cattle, kidney................................ 0.05 None
[[Page 17908]]
* * * * *
Cattle, meat.................................. 0.05 None
* * * * *
Cherimoya..................................... 0.30 None
* * * * *
Citrus, dried pulp............................ 7.5 None
Citrus, oil................................... 80 None
* * * * *
Custard, apple................................ 0.30 None
Feijoa........................................ 0.30 None
Fruit, Citrus, Group 10....................... 2.5 None
Fruit, Pome, Crop Group 11.................... 4.0 None
* * * * *
Goat, kidney.................................. 0.05 None
Goat, meat.................................... 0.05 None
* * * * *
Guava......................................... 0.30 None
* * * * *
Hog, kidney................................... 0.05 None
Hog, meat..................................... 0.05 None
* * * * *
Horse, kidney................................. 0.05 None
Horse, meat................................... 0.05 None
* * * * *
Ilama......................................... 0.30 None
Jaboticaba.................................... 0.30 None
* * * * *
Lettuce, head................................. 5.0 None
Lettuce, leaf................................. 13.0 None
Mamey sapote.................................. 0.30 None
Mango......................................... 0.30 None
* * * * *
Papaya........................................ 0.30 None
Passion fruit................................. 0.30 None
Peach......................................... 9.0 None
* * * * *
Sapodilla..................................... 0.30 None
* * * * *
Sheep, kidney................................. 0.05 None
Sheep, meat................................... 0.05 None
* * * * *
Soursop....................................... 0.30 None
* * * * *
Star apple.................................... 0.30 None
Starfruit..................................... 0.30 None
Sugar apple................................... 0.30 None
* * * * *
Vegetable, Cucurbit, Group 9.................. 0.50 None
Wax jambu..................................... 0.30 None
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-7066 Filed 4-7-05; 8:45 am]
BILLING CODE 6560-50-S