[Federal Register: September 22, 2006 (Volume 71, Number 184)]
[Rules and Regulations]
[Page 55307-55313]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22se06-8]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0170; FRL-8092-2]
Buprofezin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for combined residues
or residues of buprofezin in or on almond hulls; cotton, gin
byproducts: Cottonseed; and tomato. Nichino America, Inc., Linden Park
Suite 501, 4550 New Linden Hill Road, Wilmington, DE 19908 requested
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA),
as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective September 22, 2006. Objections and
requests for hearings must be received on or before November 21, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0170. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The 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: Kevin Sweeney, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5063; e-mail address: sweeney.kevin@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.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the
[[Page 55308]]
submission of objections and requests for hearings appear in 40 CFR
part 178. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0170. in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before November 21, 2006.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0170, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of June 21, 2000 (65 FR 38549) (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 Road, Wilmington, DE, 19808. The petition requested that 40 CFR
180. 511 be amended by establishing a tolerance for combined residues
or residues of the insecticide buprofezin, 2[(1,1-di-
methylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-
thiadizin-4-one, in or on almond hulls at 0.7 parts per million (ppm);
cotton, gin byproducts at 23 ppm; cotton, undelinted seed at 1.0 ppm;
and tomato at 0.8 ppm at tolerance level ppm. That notice included a
summary of the petition prepared by Aventis CropScience USA LP
(formerly AgrEvo USA Company), 2 T.W. Alexander Drive, Research
Triangle Park, NC 27709, the registrant. There were no comments
received in response to the notice of filing. Subsequently, in the
Federal Register of September 5, 2001 (66 FR 46381) (FRL-6696-6), EPA
issued a Final Rule to section 408 of FFDCA, 21 U.S.C. 345a(d)(3), that
established time limited tolerances for residues of the insecticide
[buprofezin, 2-[(1,1-di- methylethyl)imino]tetrahydro-3(1-methylethyl)-
5-phenyl-4H-1,3,5-thiadiazin-4-1], in or on almond hulls at 0.7 ppm;
cotton, gin byproducts at 15.0 ppm; cotton, undelinted seed at 0.4 ppm;
and tomato at 0.40 ppm. These tolerances expired on December 31, 2005.
The conditions for these time limited tolerances were as follows: A
comparative thyroid assay (young/adult rat), a revised section B, a
revised section F, Plant Enforcement Method (BF/10/97)- Confirmatory
Method, Interference Study, and successful Agency Validation, Plant
Enforcement Method (BF/02/96) - Confirmatory Method and Interference
Study, Livestock Enforcement Method - successful Agency Validation and
Radiovalidation, Storage Stability Data, validation of frozen storage
intervals, petition method validation, an interference study,
Additional almond, banana, citrus, cotton, and tomato field trial data,
and a citrus processing study. EPA reevaluated the available thyroid
toxicity data in regard to the severity of effects and hormonal
measurements and concluded that a study evaluating thyrioid levels in
adult rats would be more appropriate. This study is confirmatory and is
not a condition of granting these tolerances. All of the conditions
above have been addressed and the Agency is issuing permanent
tolerances based on the registrant's proposed final rule request dated
August 25, 2005 (November 30, 2005 (70 FR 71838) (FRL-7735-7)).
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/
[fxsp0]EPA-PEST/1997/November/[fxsp0]Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for combined residues or residues
of buprofezin on almond, hulls at 2.0 ppm; cotton, gin byproducts at 20
ppm; cotton, undelinted seed at 0.35 ppm; and tomato at 0.40 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by buprofezin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the OPP
Regulatory Public Docket number EPA-HQ-OPP-2006-0170.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which NOAEL from the toxicology study
identified as appropriate for use in risk assessment is used to
estimate the toxicological level of concern (LOC). However, the LOAEL
[[Page 55309]]
identified is sometimes used for risk assessment if no NOAEL was
achieved in the toxicology study selected. An uncertainty factor (UF)
is applied to reflect uncertainties inherent in the extrapolation from
laboratory animal data to humans and in the variations in sensitivity
among members of the human population as well as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for buprofezin used for
human risk assessment is shown in the following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for Buprofezin for Use in Human Risk Assessment
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Dose Used in Risk
Assessment, Special FQPA SF and
Exposure/Scenario Interspecies and Level of Concern (LOC) Study and Toxicological
Intraspecies and any for Risk Assessment Effects
Traditional UF
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Acute dietary (females 13-49 years of NOAEL = 200 mg/kg/day Special FQPA SF = 1 LOAEL = 800 mg/kg/day
age) UF = 100............... aPAD = acute RfD/ based on incomplete
Acute RfD = 2.0 mg/kg/ Special FQPA SF = 2.0 ossification and
day. mg/kg/day. reduced pup weight
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Acute dietary (general population NOAEL = NA1 mg/kg/day Special FQPA SF = NA1 No appropriate endpoint
including infants and children) UF = NA................ aPAD = acute RfD....... was identified for the
Acute RfD = NA mg/kg/ Special FQPA SF = NA mg/ general population
day. kg/day. LOAEL = NA mg/kg/day
based on NA
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Chronic dietary (all populations) NOAEL = 1.0 mg/kg/day Special FQPA SF = 1 Two-year chronic
UF = 300............... cPAD = chronic RfD feeding study - rat
Chronic RfD = 0.0033 mg/ Special FQPA SF = LOAEL = 8.7 mg/kg/day
kg/day. 0.0033 mg/kg/day. based on organ weight
changes and
microscopic findings
in the liver and
thyroid of both males
and females and in the
kidney of males
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Short-term incidental oral (1-30 Oral NOAEL = 13.0 mg/kg/ Residential = NA2 90-day oral toxicity
days) day study -rat
(Residential = NA2).................. LOAEL 68.6 mg/kg/day
based on
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Short-term dermal (1 to 30 days) Dermal NOAEL = 300 mg/ Occupational LOC for 24-Day dermal toxicity
(Residential = NA2................... kg/day (dermal MOE = < 100 study - rat
absorption rate = (Residential = NA2).... LOAEL = 1,000 mg/kg/day
NA2%) based on inflammatory
infiltrate of the
liver in females and
increase in acanthosis
and hyperkeratosis of
the skin in females
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Intermediate-term dermal (1 week to Dermal NOAEL = 300 mg/ Occupational LOC for 24-Day dermal toxicity
several months) kg/day (dermal MOE = < 100 study - rat
(Residential = NA2).................. absorption rate = (Residential = NA2).... LOAEL = 1,000 mg/kg/day
NA2%) based on inflammatory
infiltrate of the
liver in females and
increase in acanthosis
and hyperkeratosis of
the skin in females
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to Oral NOAEL = 1.0 mg/kg/ Occupational LOC for Two-year chronic
lifetime) day (dermal absorption MOE = < 300 feeding study - rat
(Residential = NA2).................. rate = 10%) (Residential = NA2).... LOAEL = 8.7 mg/kg/day
based on based on
increased incidence of
follicular cell
hyperplasia and
hypertrophy in the
thyroid in males
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Short-term inhalation (1 to 30 days) Oral study NOAEL = 13.0 Occupational LOC for 90-Day oral toxicity
(residential = NA2) mg/kg/day (inhalation MOE = < 300 study - rat
absorption rate = (Residential = NA2).... LOAEL = 68.6 mg/kg/day
100%) based on organ weight
changes and
microscopic findings
in the liver and
thyroid of both males
and females and in the
kidney of males
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week Oral study NOAEL = 13.0 Occupational LOC for 90-Day oral toxicity
to several months) mg/kg/day (inhalation MOE = < 300 study - rat
(Residential = NA2).................. absorption rate = (Residential = NA2).... LOAEL = 68.6 mg/kg/day
100%) based on organ weight
changes and
microscopic findings
in the liver and
thyroid of both males
and females and in the
kidney of males
----------------------------------------------------------------------------------------------------------------
[[Page 55310]]
Long-term inhalation (several months Oral study NOAEL = 1.0 Occupational LOC for Two-year chronic
to lifetime) mg/kg/day (inhalation MOE = < 300 feeding study -rat
(Residential = NA2).................. absorption rate = (Residential = NA2).... LOAEL = 8.7 mg/kg/day
100%) based on increased
incidence of
follicular cell
hyperplasia and
hypertrophy in the
thyroid of males
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) No quantification No quantification No quantification is
appropriate because
the evidence was
limited to one sex in
one species of animal.
The data show no
greater than
suggestive evidence of
carcinogenicity.
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1NA = Not applicable.
2NA = Not applicable. There are no residential uses for buprofezin.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.511) for the combined residues or residues of
buprofezin, in or on a variety of raw agricultural commodities.
Tolerances of buprofezin are established in milk at 0.01 ppm and in
ruminant fat (0.05 ppm), meat byproducts (0.05 ppm), and liver at 0.05
ppm. Risk assessments were conducted by EPA to assess dietary exposures
from buprofezin in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
The Dietary Exposure Evaluation Model (DEEMTM) analysis
evaluated the individual food consumption 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 DEEM (ver. 7.76)
default processing factors and 100% crop treated (CT) for all
commodities. Tolerance level residues were assumed for all commodities
excluding meat and milk. Since meat and milk (LOQ tolerances) residues
were only detected in the feeding study at 6.8-9.3x the Maximum
Theoretical Dietary Burden (MTDB), residues in these commodities were
normalized to 1x the MTDB. The acute analysis also incorporated the
acute Pesticide Root Zone Model/Exposure Analysis Modeling System
(PRZM-EXAMS) surface drinking water estimate resulting from application
of buprofezin to citrus in Florida (highest acute drinking water
estimate). No acute endpoint was identified for the remaining
population subgroups.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEMTM software with the FCID, which
incorporates food consumption data as reported by respondents in the
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: The chronic analysis assumed DEEM (ver. 7.76) default
processing factors for all commodities and incorporated percent crop
treated (PCT) estimates or projected PCT estimates. Tolerance level or
average field trial residues were assumed for all crop commodities and
since meat and milk (LOQ tolerances) residues were only detected in the
feeding study at 6.8-9.3x the MTDB, residue in these commodities were
normalized to 1x the MTDB. The chronic analysis also incorporated the
chronic PRZM-EXAMS surface drinking water estimate resulting from
application of buprofezin to citrus in Florida (highest chronic
drinking water estimate).
iii. Cancer. Due to the fact that the data showed no greater than
suggestive evidence of carcinogenicity, the chronic exposure and risk
assessment was deemed protective of any cancer effect.
iv. Anticipated residue and 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: 10% CT for cantaloupes;
5% CT for cauliflower; 2.5% CT for cotton, grapefruit, grapes,
honeydew, lemons, oranges, tomatoes, and watermelon; market share PCT
was projected not to exceed 5% for apples, and 13% for peaches for the
first four to five years buprofezin is on the market. All other crops
currently registered and/or proposed commodities were assumed to be
100% CT. The Agency believes that the three conditions listed in Unit
C.1.iv. 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 exposure assessments. For most newly
registered crops, the Agency assumed 100% CT. In estimating PCT for the
apples, EPA assumed that the PCT for
[[Page 55311]]
buprofezin would at least equal or exceed the PCT for the leading
comparable insect growth regulator pesticide alternative on that crop.
For peaches, PCT for buprofezin was projected to potentially exceed the
leading alternative's PCT 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 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. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the PRZM/EXAMS and Screening Concentration in Ground Water
(SCI-GROW) models, the estimated environmental concentrations (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.
Modeled estimates of drinking water concentrations were directly
entered into the DEEMTM/FCID. For chronic dietary risk
assessment, the annual average concentration of 4.5 ppb was used to
access the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
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 the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to 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 Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at 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
margin of exposure (MOE) analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional safety factor value based on the use of
traditional UFs and/or special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. Prenatal and postnatal
sensitivity is not of concern for buprofezin based on the results of
the developmental toxicity studies in rats and rabbits and the two-
generation reproduction study in rats. The results indicate that there
is no increased susceptibility of rats or rabbits following in utero
exposure or of rats following prenatal/postnatal exposure to
buprofezin. The toxicology data do not indicate a basis for concern for
neurotoxicity, therefore, acute, subchronic, and developmental
neurotoxicity studies are not required.
3. Conclusion. Oral exposure to buprofezin produced marginal
thyroid toxicity in adult rats manifested as increased incidence of
follicular cell hyperplasia, increased in thyroid weights and
microscopic findings in the thyroid. Although rats are very susceptible
to thyroid hormone disruption and thyroid follicular cell
carcinogenesis, no thyroid tumors were observed in chronic and
carcinogenicity studies in mice and rats. It is unknown to what extent
buprofezin alters thyroid hormones (T3, T4 and Thyroid-Stimulating
hormone levels) because these were not measured. Given the marginal
thyroid toxicity found, it is anticipated that any effects of
buprofezin on thyroid hormones may also be marginal. Thus, a
measurement of thyroid hormones in adult rats is viewed as a
confirmatory test to evaluate its effect on thyroid homeostasis. A FQPA
factor of 10X in the form of database UF is applied to chronic
Referance Dose (cRfD), chronic dermal exposure (endpoint based on oral
study) and all inhalation exposure durations as a conservative approach
to address any residual uncertainty associated with potential
susceptibility of the young to thyroid disruption. This FQPA factor in
the form of database uncertainty is not applicable to acute oral RfD
because a single dose of a chemical would not be expected to perturb
thyroid homeostasis in the adult or young due to the buffering of
thyroid hormone concentrations by homeostatic mechanisms for compound
with short half lives, like buprofezin (half-life of a couple of days).
This FQPA factor in the
[[Page 55312]]
form of database uncertainty is not applicable to short-and
intermediate-term dermal exposure because the endpoint of concern is
based on dermal study where liver toxicity was the critical effect
(thyroid effects were not observed). Since the thyroid effects were
seen in rats and it has been established that rats are more susceptible
to thyroid effects than humans, the Agency concluded that the
interspecies extrapolation factor for these assessments may be reduced
to 3X. The intraspecies variability factor remains as 10x. There is no
evidence of increased susceptibility due to postnatal exposure to
buprofezin in rats and rabbits or prenatal and postnatal exposure in
two-generation reproduction study. Therefore, there is no need to
retain the FQPA safety factor (SF) based on prenatal or postnatal
toxicity issues. Based on the conservative residue assumptions used in
the dietary risk assessment (there are currently no residential
exposures), and the completeness of the residue chemistry and
environmental fate databases, there is no need to retain the FQPA SF
based on exposure issues.
The total UF for chronic dietary, inhalation assessments (all
durations) and long-term dermal assessment is 300X (10X FQPA database
uncertainty, 3X interspecies variation, and 10X intraspecies variation)
and the total UF for acute dietary and dermal assessments (short-term
and intermediate-term) is 100X (10X interspecies variation and 10x
intraspecies variation).
E. Aggregate Risks and Determination of Safety
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to buprofezin will occupy 5% of the acute population adjusted dose
(aPAD) for females 13-49 years old. EPA does not expect the aggregate
exposure to exceed 100% of the aPAD.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
buprofezin from food will utilize 40% of the chronic population
adjusted dose (cPAD) for the U.S. population, 56% of the cPAD for all
infants less than 1-year old, and 87% of the cPAD for children 1-2
years old. There are no residential uses for buprofezin that result in
chronic residential exposure to buprofezin. Therefore, the EPA does not
expect the aggregate exposure to exceed 100% of the cPAD.
3. 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 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 summary,
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.
4. 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 using gas chromatography with
nitrogen phosphorous detection (GC/NPD) is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
There are no Canadian, Mexican, or Codex maximum residue limits
established for buprofezin in/on any of the commodities associated with
the current petition.
V. Conclusion
Therefore, the tolerance is established for combined residues or
residues of buprofezin, in or on almond, hulls at 2.0 ppm; cotton, gin
byproducts at 20 ppm; cotton, undelinted seed at 0.35 ppm; and tomato
at 0.40 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various
[[Page 55313]]
levels of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 12, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.511 is amended by alphabetically revising commodities
and adding cotton seed to the table in paragraph (a) to read as
follows:
Sec. 180.511 Buprofezin; tolerance for residues
(a) * * *
------------------------------------------------------------------------
Expiration/revocation
Commodity Parts per million dates
------------------------------------------------------------------------
* * * * *
Almond hulls................ 2.0 None
------------------------------------------------------------------------
* * * * *
Cotton, gin byproducts...... 20.0 None
------------------------------------------------------------------------
Cotton seed................. 0.35 None
------------------------------------------------------------------------
* * * * *
Tomato...................... 0.40 None
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 06-8065 Filed 9-21-06; 8:45 am]
BILLING CODE 6560-50-S