[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Rules and Regulations]
[Pages 17901-17908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7066]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0412; FRL-7691-8]


Buprofezin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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: 
[email protected].

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: 
[email protected].

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: [email protected]. 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