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Hydramethylnon (BASF).
August 13, 2003. Pesticide Tolerance for Pineapple at 0.05 ppm.
Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2003/August/Day-13/p20432.htm
[Federal Register: August 13, 2003 (Volume 68, Number 156)]
[Rules and Regulations]
[Page 48302-48312]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au03-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0251; FRL-7319-5]
Hydramethylnon; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
hydramethylnon in or on pineapple. BASF 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 August 13, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0251,
must be received on or before October 14, 2003.
[[Page 48303]]
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Richard J. Gebken, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 305-6701; e-mail address:
gebken.richard@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
¥ Crop production (NAICS 111)
¥ Food manufacturing (NAICS 311)
¥ Pesticide manufacturing (NAICS 32532)
¥ Animal production (NAICS 112)
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 Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0251 The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2,
1921 Jefferson Davis Hwy., 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.
2. Electronic access. 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 http://www.access.
gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, 
a beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of October 6, 1999 (64 FR Page 54300-54303)
(FRL-6029-9), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the
filing of a pesticide petition (PP 2F02609) by BASF Corporation, 26
Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528.
That notice included a summary of the petition prepared by BASF
Corporation, the registrant. There were no comments received in
response to the notice of filing.
The petition requested that 40 CFR 180.395 be amended by
establishing a tolerance for residues of the insecticide Hydramethylnon
in or on pineapple at 0.05 parts per million (ppm).
Section 408(b)(2)(A)(i) of the 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 the 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 the 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 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 the 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 the FFDCA, for a tolerance for residues of hydramethylnon
on pineapple at 0.05 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 hydramethylnon are
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies reviewed.
[[Page 48304]]
Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 Subchronic Feeding NOAEL = 2.5 mg/kg/
- Rat day
LOAEL = 5.0 mg/kg/
day - decreased
testicular
weights (34%),
and testicular
atrophy.
------------------------------------------------------------------------
870.3150 Subchronic Gavage - NOAEL = 3 mg/kg/
Dog day - LDT;
decreased food
consumption (11%/
20%, males/
females) and body
weight gain (11%/
9%, males/
females).
LOAEL = not
defined
Lethal Dose = 6
mg/kg/day -
decreased food
consumption and
body weight gain,
↑SGPT, cachexia,
wasting of muscle
and subcutaneous
fat, testicular
atrophy, and
death.
------------------------------------------------------------------------
870.3150 Subchronic Gavage - NOAEL = 1.0 mg/kg/
Dog day
LOAEL = 3.0 mg/kg/
day - increased
incidence of soft
stools, mucoid
stools, and
diarrhea.
------------------------------------------------------------------------
870.3200 21-Day Dermal - NOAEL = 250 mg/kg/
Rabbit day (HDT)
Food consumption
was depressed as
much as 38% and
45% in the high-
dose males and
females, compared
to controls. The
high-dose males
and females
weighed as much
as 8% and 9% less
than the
controls. The
platelet count in
the high-dose
females at
termination was
54% less than
controls, but was
not considered
adverse because
it is a common
finding following
skin abrasion.
------------------------------------------------------------------------
870.3700 Developmental Maternal NOEL = 3
Toxicity - Rat mg/kg/day
Maternal NOAEL =
10 mg/kg/day - 8%
decrease in body
weight and
yellowish
discoloration of
the fat.
Maternal LOAEL =
30 mg/kg/day -
16% decrease in
body weight;
increased
incidence of
nasal mucus,
alopecia, soft
stools, staining
of the anogenital
fur, yellowish
discoloration of
the fat, and
small thymus.
Developmental
NOEL = 10 mg/kg/
day
Developmental
LOAEL = 30 mg/kg/
day - decreased
mean fetal
weights and
increased
incidence of
rudimentary
structures and
incompletely
ossified
supraoccipitals.
At 30 mg/kg/day,
a 16% decrease in
maternal body
weight, increased
incidence of
clinical signs
(nasal mucus,
alopecia, soft
stool, staining
of anogenital
fur), yellowish
discoloration of
the fat, and
small thymus were
observed.
------------------------------------------------------------------------
870.3700 Developmental Maternal NOAEL = 5
Toxicity - Rabbit mg/kg/day - soft
stools, and
reduced amount of
stools.
Maternal LOAEL =
10 mg/kg/day -
abortions, soft
stools, reduced
amount of stools,
and anogenital
matting and
discharge.
Developmental
NOAEL = 5 mg/kg/
day - decreased
fetal weight
(8%).
Developmental
LOAEL = 10 mg/kg/
day - abortions,
decreased fetal
weight (16%).
------------------------------------------------------------------------
870.3800 2-Generation Reproductive/
Reproductive Systemic NOAEL =
Toxicity - Rat 25 ppm (1.66/2.01
mg/kg/day, male/
female)
Reproductive/
Systemic LOAEL =
50 ppm (3.32 /
4.13 mg/kg/day,
male/female)
(degeneration of
the germinal
epithelium (1/29)
and aspermia (1/
29)
------------------------------------------------------------------------
870.4100 Chronic Feeding See 870.3150
Toxicity - Dog
------------------------------------------------------------------------
870.4200 Carcinogenicity NOAEL = 25 ppm
Feeding - Mouse (3.57 mg/kg/day)
(18 months) in males
NOAEL = not
defined in
females.
LOAEL = 50 ppm
(6.93 mg/kg/day)
in males
(testicular
lesions)
LOAEL = 25 ppm
(4.45 mg/kg/day)
in females (LDT;
combined lung
adenomas and
carcinomas)
The high-dose
females were
sacrificed after
5 weeks due to
high mortality.
------------------------------------------------------------------------
[[Page 48305]]
870.4300 Chronic Feeding NOAEL = 50 ppm
Toxicity/ (2.4 mg/kg/day in
Carcinogenicity- males, 3.0 mg/kg/
Rat day in females)
LOAEL = 100 ppm
(4.9 mg/kg/day in
males, 6.2 mg/kg/
day in females)
(small, soft
testes, decreased
testicular
weights, and
testicular
atrophy in males;
decreased body
weight gain in
females)
------------------------------------------------------------------------
870.5100 Bacterial Reverse Negative
Mutation Test
(Ames Assay)
------------------------------------------------------------------------
870.5375 In Vitro Negative
Chromosomal
Aberration in
Chinese Hamster
Ovary (CHO) Cells
------------------------------------------------------------------------
870.5450 Rodent Dominant Negative
Lethal Assay -
Rat
------------------------------------------------------------------------
870.5575 D4 Mitotic Gene Negative
Conversion Assay
------------------------------------------------------------------------
P1 Forward Gene Negative
Mutation Assay
------------------------------------------------------------------------
870.7485 Metabolism - Rat The majority of
the administered
dose of phenyl-
or pyrimidinyl-
14C-Cl 217,300
was recovered in
the feces (85-
98%). Recovery in
the urine was
minimal (1- to 2%
of the
administered
dose). There were
no sex or dose-
related
differences in
urinary or fecal
elimination.
------------------------------------------------------------------------
870.7600 Dermal Penetration Sprague-Dawley
- Rat rats were
dermally dosed
with a gel
formulation
containing 2%
a.i. (Maxforce
Gel[reg]). Total
dose absorbed
after 10 hours
was 0.414%
------------------------------------------------------------------------
870.7600 Dermal Penetration Sprague-Dawley
- Rat rats were
dermally dosed
with a gel
formulation
containing 2.16%
a.i.
(Siege[reg]).
Total dose
absorbed after 10
hours was 0.97%
------------------------------------------------------------------------
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 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 intra species differences.
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 the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factors
(SF) is retained due to concerns unique to the FQPA, 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 FQPA SF.
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 is expressed as 1 x 10-6 or one in a million).
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 hydramethylnon used for human risk assessment is shown in
the following Table 2:
[[Page 48306]]
Table 2.--Summary of Toxicological Dose and Endpoints for hydramethylnon for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of NOAEL = 5 mg/kg/day FQPA SF = 1 Developmental toxicity
age) UF = 100............... aPAD = acute RfD / FQPA in rabbits
Acute RfD = 0.05 mg/kg/ SF = 0.05 mg/kg/day. LOAEL = 10 mg/kg/day
day. based on abortions.
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population - - There is no appropriate
including infants and children) single dose endpoint
for the general
population.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL= 1.66 mg/kg/day FQPA SF = 1 cPAD = 2-Generation
UF = 100............... chronic RfD / FQPA SF reproductive toxicity
Chronic RfD = 0.017 mg/ = 0.017 mg/kg/day in rats
kg/day. LOAEL = 3.32 mg/kg/day
based on testicular
effects.
----------------------------------------------------------------------------------------------------------------
Short-Term Incidental Oral (1-30 Oral NOAEL= 1.66 mg/kg/ LOC for MOE = 100 2-Generation
days) day (Residential) reproductive toxicity
in rats
LOAEL = 3.32 mg/kg/day
based on testicular
effects.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Incidental Oral (1- Oral NOAEL= 1.66 mg/kg/ LOC for MOE = 100 2-Generation
6 months) day (Residential) reproductive toxicity
in rats
LOAEL = 3.32 mg/kg/day
based on testicular
effects.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 30 Oral NOAEL= 1.66 mg/kg/ LOC for MOE = 100 2-Generation
days)(Residential) day (dermal absorption (Residential) reproductive toxicity
rate = 1%) in rats
LOAEL = 3.32 mg/kg/day
based on testicular
effects.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 week to 6 Oral NOAEL = 1.66 mg/kg/ LOC for MOE = 100 2-Generation
months) (Residential) day(dermal absorption (Residential) reproductive toxicity
rate = 1%) in rats
LOAEL = 3.32 mg/kg/day
based on testicular
effects.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to Oral NOAEL= 1.66 mg/kg/ LOC for MOE = 100 2-Generation
lifetime) (Residential) day (dermal absorption (Residential) reproductive toxicity
rate = 1%) in rats
LOAEL = 3.32 mg/kg/day
based on testicular
effects.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7 days) inhalation (or oral) LOC for MOE = 100 2-Generation
(Residential) study NOAEL= 1.66 mg/ (Residential) reproductive toxicity
kg/day(inhalation in rats
absorption rate = LOAEL = 3.32 mg/kg/day
100%) based on testicular
effects.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week inhalation (or oral) LOC for MOE = 100 2-Generation
to several months) (Residential) study NOAEL = 1.66 mg/ (Residential) reproductive toxicity
kg/day(inhalation in rats
absorption rate = LOAEL = 3.32 mg/kg/day
100%) based on testicular
effects.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months inhalation (or oral) LOC for MOE = 100 2-Generation
to lifetime) (Residential) study NOAEL= 1.66 mg/ (Residential) reproductive toxicity
kg/day(inhalation in rats
absorption rate = LOAEL = 3.32 mg/kg/day
100%) based on testicular
effects.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) The Agency's Cancer Peer Review Committee determined that hydramethylnon
should be classified as a Group C-possible human carcinogen, and
recommended that, for the purpose of risk characterization, the
Reference Dose approach should be used for quantification of human risk.
The Cancer Peer Review report was issued on March 28, 1991. The Agency's
HIARC committee concurred with the cancer classification on March 4,
2003.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.395) for the residues of hydramethylnon, on
grass and grass hay for pasture and rangeland at 0.05 ppm established
in terms of parent only, tetrahydro-5,5-dimethyl-2(1H)-pyrimidinone (3-
(4-(trifluoromethyl)phenyl)-1-(2-(4-(trifluoromethyl)phenyl)ethenyl)-2-
propenylidene) hydrazone. The Agency determined that the residue of
concern in grasses and the milk, meat, and meat byproducts of ruminants
is hydramethylnon per se, and that there is no reasonable expectation
of finite hydramethylnon residues of concern in
[[Page 48307]]
the milk, meat, and meat byproducts of ruminants 40 CFR 180.6(a)(3) as
a result of hydramethylnon use on grasses. The Agency has also
previously recommended that the grass forage tolerance be increased to
2.0 ppm and the grass hay tolerance be increased to 0.1 ppm. The
residue chemistry and toxicological databases support the requested
tolerance of 0.05 ppm for hydramethylnon on pineapple. Since there are
no detectable hydramethylnon residues in the pineapple feed item,
process residues, tolerances for hydramethylnon residues in animal
commodities need not be established. Risk assessments were conducted by
EPA to assess dietary exposures from hydramethylnon in food as follows:
i. Acute 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 one day
or single exposure. An unrefined, Tier 1 acute dietary exposure
assessment was conducted using tolerance-level residues and assuming
100% crop treated (CT) for all registered and proposed commodities. The
acute analysis was conducted for females 13-49 years old only as no
appropriate single dose endpoint was established for the general U.S.
population and infants and children.
The acute dietary exposure estimates are well below the Agency's
level of concern (<100% aPAD) at the 95th exposure percentile for
females 13-49 years old (<1% of the aPAD).
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM[reg])
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1994-1996/1998 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: A Tier 1 (conservative, deterministic
assessment using tolerance-level residues, and 100% crop treated (CT)
for the proposed commodity; and DEEM-FCID[reg]
ver. 1.30,
processing factors set to (1) a chronic dietary exposure assessment was
conducted for the general U.S. population and various population
subgroups. The chronic dietary exposure estimates are well below the
Agency's level of concern (<100% cPAD) for the general U.S. population
(<1% of the cPAD) and all population subgroups.
iii. Cancer. In a chronic feeding/carcinogenicity study in Charles
River CD rats, no compound-related clinical signs were observed and
survival was not affected by treatment. The LOAEL was based on small,
soft testes, decreased testicular weights (27%), and testicular atrophy
in males; and decreased body weight gain in females (22%).
Statistically significant findings of neoplasia were found in the
uterus (adenomatous polyps) and adrenals (medullary adenomas), but
these were not considered toxicologically significant because they were
seen at doses above the MTD.
In an 18 month carcinogenicity feeding study in Charles River CD-1
mice, survival decreased as the dose increased, but not enough to
jeopardize the study. The LOAEL was based on testicular degeneration
(hypospermia, interstitial cell hyperplasia of Leydig cells, and
germinal cell degeneration) in males, and combined lung adenomas and
carcinomas in females. Findings of hyperplasia and neoplasia in the
lungs of males were not considered toxicologically significant because
they were seen at doses above the MTD. Findings in females of
statistically significant increases in lung adenomas and combined lung
adenomas/carcinomas were, however, considered toxicologically
significant.
The Agency's Cancer Peer Review Committee classified hydramethylnon
as a Group C-possible human carcinogen, and recommended that, for the
purpose of risk characterization, the Reference Dose approach should be
used for quantification of human risk. This classification was based
upon statistically significant increases in lung adenomas and combined
lung adenomas/carcinomas in female mice. Dietary risk concerns due to
long-term consumption of hydramethylnon residues are adequately
addressed by the chronic exposure analysis using the RfD.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(F) of the 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 the FFDCA, EPA may require registrants to
submit data on PCT.
A routine chronic dietary exposure analysis for pineapple was based
on 100% of pineapple crop treated, and 100% of grasses, forage (pasture
and rangeland) treated with hydramethylnon.
The Agency believes that the three conditions previously discussed
have been met. With respect to Condition 1, EPA used a conservative,
model assessment as outlined in Unit III.C.1.ii. above, using
tolerance-level residues and 100% CT for the proposed commodity
pineapple, and existing commodities. 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 hydramethylnon 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 hydramethylnon 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 use pattern,
physical characteristics and environmental fate of hydramethylnon.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The screening concentation in ground water (SCI-GROW) model
is used to predict pesticide concentrations in shallow groundwater. For
a screening-level assessment for surface water EPA will use FIRST (a
tier 1
[[Page 48308]]
model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides and an index reservoir with the percent crop
area adjustment.
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 and transformation of
pesticides from the source water. The primary use of these models by
the Agency at this stage is to provide an initial screen for sorting
out pesticides for which it is highly unlikely that drinking water
concentrations would ever 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 from these models to quantify
drinking water exposure and risk as a percent of reference dose or
percent of population adusted dose (%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 hydramethylnon they are
further discussed in the aggregate risk sections in Unit III.E.
Based on the FIRST and SCI-GROW models the EECs of hydramethylnon
for acute exposures are estimated to be 76.09 parts per billion (ppb)
for surface water and 0.035 ppb for ground water. The EECs for chronic
exposures are estimated to be 1.45 ppb for surface water and 0.035 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).
Hydramethylnon is currently registered for use on the following
residential non-dietary sites: Hydramethylnon is used as a bait in
child resistant packaging (CRP) and as a gel bait to control ants and
roaches indoors, and as a granular formulation to control ants in yards
and on lawns. It is also applied by pest control operators (PCOs) in
the same forms for indoor and outdoor pest control. The risk assessment
was conducted using the following residential exposure assumptions: The
Agency has completed a non-dietary exposure and risk assessment for
hydramethylnon including the following uses: residential consumers
applying granular and gel formulations; children and adults contacting
recreational turf or residential lawns treated with hydramethylnon; and
toddlers' incidental nondietary ingestion of products applied around
the home. Non-occupational handler exposures from the granular
formulations applied to outdoor residential sites are assumed to be
short-term in duration, based on rapid dissipation and insect foraging.
No chemical-specific data were submitted for the registration of
hydramethylnon uses. Per an Agency policy, non-occupational handler
assessments are based on surrogate unit exposures from the draft
Standard Operating Procedures (SOPs) for Residential Exposure
Assessments (12/18/97) and recommended approaches by the Agency's
Exposure Science Advisory Committee (ExpoSAC). Updates to the
Residential SOPs (02/01) alter the residential postapplication scenario
assumptions. These updated assumptions are expected to better represent
residential exposure and are still considered to be high-end, screening
level assumptions. The non-occupational handler assessments for push
type granular spreaders were based on surrogate unit exposures from two
Outdoor Residential Exposure Task Force (ORETF) studies.
The ant bait stations containing hydramethylnon are in child-
resistant packaging (CRP). The bait stations are supposed to be placed
in less accessible locations such as in or under kitchen counters.
However, handling or mouthing of the bait stations is the most commonly
reported incidental ``exposure'' to hydramethylnon. Such exposures
involve, at most, children mouthing the bait container with little or
no contact with the actual bait. In the absence of an applicable acute
dietary endpoint, and with the vast majority of incident data resulting
in little or no health effects, no quantitative assessment of
accidental exposure to the internal contents of bait stations was
conducted. The gel product containing hydramethylnon is supposed to be
applied in dime-sized portions in locations inaccessible to children.
Accidental ingestion of gel from such application is considered
unlikely and was therefore not assessed.
Adult consumer exposures when installing and removing bait stations
are expected to be minimal. Consumer exposure when applying the gel
compound from a syringe is considered negligible. Limited accessibility
(i.e., crack, crevice, behind appliances, in crawl spaces) of the gel
and granular formulations when used by professional applicators in the
home make it unlikely that residents would be exposed to these
formulations indoors. For the proposed application of granules to
outdoor residential sites, dermal MOEs calculated for non-occupational
handlers were 10,000 or greater.
Dermal postapplication exposure from lawns treated with
hydramethylnon granules at the maximum application rate of 2.2 lb
product per acre (0.022 lb ai/A) were estimated using standard
assumptions, as no chemical-specific residue data were available. For
adults and children playing actively for two hours on a just-treated
lawn, the estimated MOEs were 41,000 and 24,000, respectively. The
aggregate (dermal, hand-mouth and object-mouth) MOE for a 15 kg child
playing on a lawn was 4,000. The MOE for incidental ingestion of 3 mg
of 1% hydramethylnon granules found on the surface of the lawn was 850.
The hydramethylnon granules are formulated as small granules to allow
for ant removal, and are therefore not easily noticed by a child, and
ingestion is unlikely.
4. Cumulative exposure to 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.''
EPA does not have, at this time, available data to determine
whether hydramethylnon has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
hydramethylnon 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 hydramethylnon 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 final rule for Bifenthrin Pesticide Tolerances (62 FR 62961,
November 26, 1997).
[[Page 48309]]
D. Safety Factor for Infants and Children
1. In general. Section 408 of the 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 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.
2. Prenatal and postnatal sensitivity. The Agency has concluded
that there is no concern for pre- and/or postnatal toxicity resulting
from exposure to hydramethylnon.
3. Conclusion. There is a complete toxicity data base for
hydramethylnon and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. The Agency
determined that no special FQPA Safety Factor is needed (1x) for
hydramethylnon. The exposure databases (dietary food, drinking water,
and residential) are complete and the risk assessment for each
potential exposure scenario includes all metabolites and/or degradates
of concern and does not underestimate the potential risk for infants
and children.
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 the model estimates of
a pesticide's concentration in water (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 USEPA 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 groundwater are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA 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, EPA 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
hydramethylnon will occupy <1% of the aPAD for females 13 years and
older. In addition, there is potential for acute dietary exposure to
hydramethylnon in drinking water. After calculating DWLOCs and
comparing them to the EECs for surface and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the aPAD, as shown in
the following Table 3:
Table 3.--Aggregate Risk Assessment for Acute Exposure to hydramethylnon.
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 0.05 <1 76.09 0.035 1,500
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
hydramethylnon from food will utilize <1% of the cPAD for the U.S.
population, and <1% (0.02%) of the cPAD for children 1-2 years old.
Based on the use pattern, chronic residential exposure to residues of
hydramethylnon is not expected. In addition, there is potential for
chronic dietary exposure to hydramethylnon in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 4:
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to hydramethylnon
----------------------------------------------------------------------------------------------------------------
Chronic
cPAD mg/kg/ Food Surface Ground Chronic
Population Subgroup day Exposure Water EEC Water EEC DWLOC (ppb)
(mg/kg/day) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.017 0.000005 1.45 0.035 600
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old) 0.017 0.000012 1.45 0.035 170
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 0.017 0.000026 1.45 0.035 170
----------------------------------------------------------------------------------------------------------------
Children (3-5 years old) 0.017 0.000016 1.45 0.035 170
----------------------------------------------------------------------------------------------------------------
[[Page 48310]]
Children (6-12 years old) 0.017 0.000008 1.45 0.035 170
----------------------------------------------------------------------------------------------------------------
Youth (13-19 years old) 0.017 0.000002 1.45 0.035 170
----------------------------------------------------------------------------------------------------------------
Adults (20-49 years old) 0.017 0.000003 1.45 0.035 600
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 0.017 0.000004 1.45 0.035 510
----------------------------------------------------------------------------------------------------------------
Adults (50+ years old) 0.017 0.000002 1.45 0.035 600
----------------------------------------------------------------------------------------------------------------
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). Hydramethylnon is
currently registered for use that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic food and water and short-term
exposures for hydramethylnon.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of exposures for both adults (MOE =
8,000; handler and post-application) and children (MOE = 680; post-
application). Therefore, the turf-treatment exposure estimates were
aggregated with the chronic dietary (food) to provide a worst-case
estimate of short-term aggregate risk for the U.S. population and
children 1-2 years old (the child population subgroup with the highest
estimated average (chronic) dietary food exposure). These aggregate
MOEs do not exceed the Agency's level of concern for aggregate exposure
to food and residential uses. In addition, short-term DWLOCs were
calculated and compared to the EECs for chronic exposure of
hydramethylnon in ground and surface water. After calculating DWLOCs
and comparing them to the EECs for surface and ground water, EPA does
not expect short-term aggregate exposure to exceed the Agency's level
of concern, as shown in the following Table 5:
Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Hydramethylnon
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
US Population 7,700 100 76.09 0.035 580
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old 3,300 100 76.09 0.035 165
----------------------------------------------------------------------------------------------------------------
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Though
residential exposure could occur with the use of hydramethylnon, an
intermediate-term aggregate risk assessment was not performed because
it is based on the same toxic endpoint and dose as the short-term, and
the higher exposure used in the short-term assessment represents a
worse case.
5. Aggregate cancer risk for U.S. population. A separate cancer
aggregate risk assessment was not performed because the Reference Dose
approach was recommended for quantification of human risk. Cancer risks
are adequately addressed by the chronic aggregate and assessment which
used the chronic reference dose (cRfD).
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 hydramethylnon residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The method presented by BASF Corporation and designated M 2458, is
the predecessor to method M 2458.01 for which BASF Corporation has
submitted as an independent method validation. The updated method
corrects some typographical errors and clarifies some of the
fractionation steps. Adequate enforcement methodology (example--gas
chromatography) 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
No maximum residue limits for hydramethylnon in/on pineapple have
been established or proposed by Codex, Canada, or Mexico for any
agricultural commodity; therefore, no compatibility concerns exist with
respect to U.S. tolerances.
C. Conditions
The following studies are required to further characterize the
environmental effects of hydramethylnon: Estuarine/marine fish
LC50 (72-1), Estuarine/marine invertebrate EC50
(72-2), and Sediment Toxicity Testing (Harmonized guidelines 850.1735
and 850.1740). In addition, the following studies are required for any
future expansion of hydramethylnon uses: Aquatic Photodegradation (161-
2), Aerobic Aquatic Metabolism (162-4), and Terrestrial Field
Dissipation (164-1).
[[Page 48311]]
D. Recommendation for Tolerances
The residue chemistry and toxicological databases support the
requested tolerance of 0.05 ppm for hydramethylnon on pineapple. The
Agency has also previously recommended that the grass (pasture and
rangeland) tolerance be increased to 2.0 ppm and the grass hay (pasture
and rangeland) tolerance be increased to 0.1 ppm (Hydramethylnon RED,
EPA 738-R-98-023, 12/98).
V. Conclusion
Therefore, the tolerance is established for residues of
hydramethylnon, in or on pineapple at 0.05 ppm., and revised for grass
(pasture and rangeland) at 2.0 ppm, and grass hay (pasture and
rangeland) at 0.1 ppm respectively.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the 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 the 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-2003-0251 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before October
14, 2003.
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 (1900C),
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 Rm.104, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. 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 Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0251, 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 Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy 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 the
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
[[Page 48312]]
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 the FFDCA, such as the tolerance in this final rule,
do not require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
In addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the 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 (59 FR 22951, 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: July 31, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.
¥ Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
¥ 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
¥ 2. Section 180.395 is amended by adding alphabetically the commodity
``pineapple'' to the table in paragraph (a) to read as follows:
Sec. 180.395 Hydramethylnon; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Pineapple............................................... 0.05
------------------------------------------------------------------------
* * * * *
[FR Doc. 03-20432 Filed 8-12-03; 8:45 am]
BILLING CODE 6560-50-S