[Federal Register Volume 68, Number 156 (Wednesday, August 13, 2003)]
[Rules and Regulations]
[Pages 48302-48312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20432]


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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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    [sbull] 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,
                                                       >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: 
[email protected].

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 [email protected], 
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: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy 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 (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 31, 2003.
Debra Edwards,
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), 346(a) and 371.

0
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