[Federal Register Volume 69, Number 139 (Wednesday, July 21, 2004)]
[Rules and Regulations]
[Pages 43525-43533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16213]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0141; FRL-7364-1]


Acequinocyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of acequinocyl, 2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione, and its 
metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, expressed as 
acequinocyl equivalents in or on almond; almond, hulls; apple, wet 
pomace; citrus, oil; fat and liver of cattle, goat, horse, and sheep; 
fruit, citrus, group 10; fruit, pome, group 11; pistachio; and 
strawberry. Arvesta Corporation requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective July 21, 2004. Objections and 
requests for hearings must be received on or before September 20, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
ID number OPP-2004-0141. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket/. Although listed in the 
index, some information is not publicly available, i.e., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 South Bell St., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Marilyn Mautz, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 305-6785; e-mail address:[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of February 25, 2004 (69 FR 8645) (FRL-
7344-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
2F6440 and 3F6596) by Arvesta Corporation, 100 First St., Suite 1700, 
San Francisco, CA 94105. That notice included a summary of the 
petitions prepared by Arvesta Corporation, the registrant. There were 
no comments received in response to the notice of filing.
    The petitions requested that 40 CFR part 180 be amended by 
establishing tolerances for combined residues of the insecticide 
acequinocyl, 3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate, and 
its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone (acequinocyl-
OH), expressed as acequinocyl equivalents, in or on the listed 
commodities as follows:

PP 2F6440: Fruit, pome group at 0.4 parts per million (ppm); apple, wet 
pomace at1.0 ppm; fruit, citrus, group at 0.3 ppm; orange, oil at 30 
ppm; almond and pistachio at 0.01 ppm; almond, hulls at 1.5 ppm; 
cattle, meat and kidney at 0.01 ppm; cattle, liver and fat at 0.02 ppm; 
and milk at 0.01 ppm.

PP 3F6595: Strawberries at 0.4 ppm

    The petition, PP 2F6440, was subsequently amended to: Increase the 
tolerances for almond and pistachio from 0.01 ppm to 0.02 ppm; increase 
the tolerance for almond hulls from 1.5 ppm to 2.0 ppm; to decrease the 
tolerance for citrus fruit group from 0.3 ppm to 0.20 ppm; add separate 
tolerances for fat and liver of goat, horse and sheep; withdraw the 
proposed tolerances for milk, and meat and kidney of cattle; and to 
correct the terms for certain commodities as summarized in the Table 1 
of this unit.
    The almond and pistachio tolerances were increased to account for 
the combined limit of quantification (LOQ) of the residue analytical 
method for the parent and its metabolite. The LOQ for each one is 0.01 
ppm in/on each plant and livestock commodity, with the exception of 
citrus oil, where the LOQ for each one is 0.5 ppm. The withdrawal of 
the proposed milk, kidney and meat commodities and the addition of 
other livestock commodities are based on the results of the submitted 
cattle feeding study.
    In addition, the chemical name is corrected from 3-dodecyl-1,4-
dihydro-1,4-dioxo-2-naphthyl acetate to 2-(acetyloxy)-3-dodecyl-1,4-
naphthalenedione to be consistent with the nomenclature used in the 
Chemical Abstracts Chemical Substance Index, published by the American 
Chemical Society.


[[Page 43526]]



                                           Table 1.--Tolerance Summary
----------------------------------------------------------------------------------------------------------------
                                        Proposed tolerance (in
              Commodity                          ppm)               Amended (in ppm)      Correct commodity term
----------------------------------------------------------------------------------------------------------------
Almond                                 0.01                     0.02
--------------------------------------
Almond, hulls                          1.5                      2.0
--------------------------------------
Apple, wet pomace                      1.0
--------------------------------------
Cattle, fat                            0.02
--------------------------------------
Cattle, kidney                         0.01                     Withdrawn
--------------------------------------
Cattle, liver                          0.02
--------------------------------------
Cattle, meat                           0.01                     Withdrawn
--------------------------------------
Fruit, citrus, group                   0.3                      0.20                     Fruit, citrus, group 10
--------------------------------------
Fruit, pome group                      0.4                      0.40                     Fruit, pome, group 11
--------------------------------------
Goat, fat                                                       0.02
--------------------------------------
Goat, liver                                                     0.02
--------------------------------------
Horse, fat                                                      0.02
--------------------------------------
Horse, liver                                                    0.02
--------------------------------------
Milk                                   0.01                     Withdrawn
--------------------------------------
Orange, oil                            30                                                Citrus, oil
--------------------------------------
Pistachio                              0.01                     0.02
--------------------------------------
Sheep, fat                                                      0.02
--------------------------------------
Sheep, liver                                                    0.02
--------------------------------------
Strawberries                           0.4                      0.40                     Strawberry
----------------------------------------------------------------------------------------------------------------


    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for tolerances for combined residues of acequinocyl 
and its metabolite, acequincyl-OH, on almond, pistachio, and the liver 
and fat of cattle, horse, goat, and sheep at 0.02 ppm; almond hulls at 
2.0 ppm; wet apple pomace at 1.0 ppm; citrus fruit crop group 10 at 
0.20 ppm; citrus oil at 30 ppm; and pome fruit crop group 11 and 
strawberry at 0.40 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by acequinocyl are 
discussed in Table 2 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 43527]]



                                Table 2.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                        Study type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity--       NOAEL = Male/Female (M/F); 16/21
                                          rodents; mouse               milligrams/kilogram/day (mg/kg/day)
                                                                      LOAEL = M/F; 81/100 mg/kg/day based on
                                                                       hepatocyte vacuolation
----------------------------------------
870.3100                                 90-Day oral toxicity--       NOAEL = M/F; 30.4/32.2 mg/kg/day
                                          rodents; rat                LOAEL = M/F; 119.5/129.2 mg/kg/day based
                                                                       on increased prothrombin times in males
                                                                       and increased activated partial
                                                                       thromboplastin times in both sexes
----------------------------------------
870.3150                                 90-Day oral toxicity--       NOAEL = M/F; 40/40 mg/kg/day
                                          nonrodents                  LOAEL = M/F; 160/160 mg/kg/day based on
                                                                       decreased body weight gains and reduced
                                                                       food efficiencies in males and for female
                                                                       beagle dogs based on increased platelet
                                                                       counts
----------------------------------------
870.3200                                 21/28-Day dermal toxicity    Systemic NOAEL = 200 mg/kg/day
                                                                      Systemic LOAEL = 1,000 mg/kg/day based on
                                                                       increased clotting factor times
                                                                      Dermal NOAEL= 1,000 mg/kg/day
                                                                      Dermal LOAEL not established
----------------------------------------
870.3700                                 Prenatal developmental--     Maternal NOAEL = 150 mg/kg/day
                                          rodents                     Maternal LOAEL = 500 mg/kg/day based on
                                                                       signs of internal hemorrhage and
                                                                       increased incidence of clinical signs
                                                                       (pale eyes, piloerection, red vaginal
                                                                       discharge)
                                                                      Developmental NOAEL = 500 mg/kg/day
                                                                      Developmental LOAEL = 750 mg/kg/day based
                                                                       on increased resorptions
----------------------------------------
870.3700                                 Prenatal developmental--     Maternal NOAEL = 60 mg/kg/day
                                          nonrodents                  Maternal LOAEL = 120 mg/kg/day based on
                                                                       treatment-related clinical signs leading
                                                                       to premature sacrifice (hematuria,
                                                                       reduced fecal output, body weight loss,
                                                                       and reduced food consumption) and gross
                                                                       necropsy findings (pale lungs and liver,
                                                                       hemorrhaging uterus, fluid in the cecum,
                                                                       fur in the stomach, blood stained vaginal
                                                                       opening, blood-stained urinary bladder
                                                                       contents/urine, and hair loss)
                                                                      Developmental NOAEL = 60 mg/kg/day
                                                                      Developmental LOAEL =120 mg/kg/day based
                                                                       on increased number of complete
                                                                       resorptions
----------------------------------------
870.3800                                 Reproduction and fertility   Parental/Systemic NOAEL = M/F; 7.3/134 mg/
                                          effects                      kg/day
                                                                      Parental/Systemic LOAEL = Males; 58.9 mg/
                                                                       kg/day based on increased incidences of
                                                                       hemorrhagic effects in F1 males.
                                                                      Parental/Systemic LOAEL was not
                                                                       established for females
                                                                      Reproductive NOAEL = M/F; 124/136 mg/kg/
                                                                       day
                                                                      Reproductive LOAEL = was not established
                                                                      Offspring NOAEL = M/F; 7.3/8.7 mg/kg/day
                                                                      Offspring LOAEL = M/F; 58.9/69.2 mg/kg/day
                                                                       based on hemorrhagic effects, swollen
                                                                       body parts, protruding eyes, clinical
                                                                       signs, delay in pupil development, and
                                                                       increased mortality post weaning
----------------------------------------
870.4100                                 Chronic toxicity--dogs       NOAEL = M/F; 80/80 mg/kg/day
                                                                      LOAEL = M/F; 320/320 mg/kg/day based on
                                                                       premature sacrifice (inappetence, body
                                                                       weight loss)
----------------------------------------
870.4300                                 Combined chronic/            NOAEL = M/F; 2.25/46.20 mg/kg/day
                                          carcinogenicity--rats       LOAEL = M/F; 9.02/93.56 mg/kg/day based on
                                                                       enlarged eyeballs in male and female rats
                                                                       (coagulopathy)
                                                                      No evidence of carcinogenicity
----------------------------------------
870.4300                                 Combined chronic/            NOAEL = M/F; 2.7/3.5 mg/kg/day
                                          carcinogenicity--mouse      LOAEL = M/F; 7.0/8.7 mg/kg/day based on
                                                                       clinical chemistry and microscopic
                                                                       nonneoplastic lesions (brown pigmented
                                                                       cells and perivascular inflammatory cells
                                                                       in liver)
                                                                      No evidence of carcinogenicity
----------------------------------------
870.5100                                 Gene mutation                There was no evidence of induced mutant
                                                                       colonies over background
----------------------------------------
870.5300                                 Gene mutation                There was no clear evidence of
                                                                       biologically significant induction of
                                                                       mutant colonies over background
----------------------------------------
870.5375                                 Chromosome aberration        There was no evidence of chromosome
                                                                       aberrations induced over background
----------------------------------------
870.5395                                 Mammalian erythrocyte        There was no statistically significant
                                          micronucleus test in mice    increase in the frequency of
                                                                       micronucleated polychromatic erythrocytes
                                                                       in mouse bone marrow at any dose or
                                                                       harvest time
----------------------------------------

[[Page 43528]]

 
870.7485                                 Metabolism and               Acequinocyl exhibits marginal absorption,
                                          pharmacokinetics             relatively rapid and complete excretion
                                                                       primarily via the bile and feces, and
                                                                       undergoes nearly complete metabolism to
                                                                       hydrolysis products and a glucuronide
                                                                       conjugate. There was no evidence for
                                                                       selective tissue accumulation or
                                                                       sequestration of acequinocyl or its
                                                                       metabolites in rats
----------------------------------------
870.7600                                 Dermal penetration           Percent of dose absorbed decreased with
                                                                       exposure concentration indicating that
                                                                       saturation of absorption at/or about the
                                                                       high dose. Absorption at 168 hours was
                                                                       12.23%, 19.75%, and 14.77% for the 0.1,
                                                                       0.01, and 0.001 mg/centimeter squared
                                                                       (cm\2\ dose groups, respectively
----------------------------------------------------------------------------------------------------------------

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 intraspecies differences.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor'' is the additional 10X safety 
factor that is mandated by the statute unless it is decided that there 
are reliable data to choose a different additional factor (potentially 
a traditional uncertainty factor or a special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, this additional factor is applied to the RfD by dividing the RfD 
by such additional factor. The acute or chronic Population Adjusted 
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this 
type of safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-\5\), one in a million (1 X 10-\6\), or 1 in 
10 million (1 X 10-\7\). Under certain specific 
circumstances, MOE calculations will be used for the carcinogenic risk 
assessment. In this non-linear approach, a ``point of departure'' is 
identified below which carcinogenic effects are not expected. The point 
of departure is typically a NOAEL based on an endpoint related to 
cancer effects though it may be a different value derived from the dose 
response curve. To estimate risk, a ratio of the point of departure to 
exposure (MOEcancer = point of departure/exposures) is 
calculated.
    A summary of the toxicological endpoints for acequinocyl used for 
human risk assessment is shown in Table 3 of this unit:

     Table 3.--Summary of Toxicological Dose and Endpoints for Acequinocyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose used in risk
                                             assessment,          Special FQPA SF and
          Exposure scenario                interspecies and       level of concern for   Study and toxicological
                                         intraspecies and any       risk assessment              effects
                                            iraditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary                          Not applicable           None                     An endpoint of concern
                                                                                          attributable to a
                                                                                          single dose was not
                                                                                          identified. An aRfD
                                                                                          was not established
--------------------------------------

[[Page 43529]]

 
Chronic dietary                        NOAEL = 2.7              FQPA SF = 1X             18-month
(all populations)....................  UF = 100X..............  \1\ cPAD = 0.027.......   carcinogenicity study
                                       cRfD = 0.027...........                            in mice;
                                                                                         LOAEL = 7.0 mg/kg/day
                                                                                          based on clinical
                                                                                          chemistry and
                                                                                          microscopic
                                                                                          nonneoplastic lesions
                                                                                          (brown pigmented cells
                                                                                          and perivascular
                                                                                          inflammatory cells in
                                                                                          liver)
----------------------------------------------------------------------------------------------------------------
NOTE: UF = uncertainty factor; FQPA SF = special FQPA safety factor; NOAEL = no observed adverse effect level;
  LOAEL = lowest observed adverse effect level; PAD = population adjusted dose (c = chronic) RfD = reference
  dose.
\1\ cPAD = cRfD/FQPA SF.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. There are no 
tolerances established for residues of acequinocyl. Risk assessments 
were conducted by EPA to assess dietary exposures from acequinocyl 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 acute exposure assessment is unnecessary because no such effect 
was seen in the submitted studies.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: Tolerance-level residues, DEEM\TM\ ver. 7.76 default 
processing factors, and 100 percent crop treated (%CT) data were used 
in the chronic dietary assessment.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for acequinocyl in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of acequinocyl.
    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 Ground Water (SCI-GROW) model is used to 
predict pesticide concentrations in shallow ground water. For a 
screening-level assessment for surface water EPA will use FIRST (a tier 
1 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. Both FIRST and PRZM/EXAMS incorporate an index 
reservoir environment, and both models include a percent crop area 
factor as an adjustment to account for the maximum percent crop 
coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD. 
Instead, drinking water levels of comparison (DWLOCs) are calculated 
and used as a point of comparison against the model estimates of a 
pesticide's concentration in water. DWLOCs are theoretical upper limits 
on a pesticide's concentration in drinking water in light of total 
aggregate exposure to a pesticide in food and from residential uses. 
Since DWLOCs address total aggregate exposure to acequinocyl they are 
further discussed on the aggregate risk in Unit III.E.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of 
acequinocyl for chronic exposures are estimated to be 0.24 parts per 
billion (ppb) for surface water and 0.003 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).
    Acequinocyl is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to acequinocyl and any other 
substances and acequinocyl 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 acequinocyl has a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the policy statements released by EPA's OPP concerning 
common mechanism determinations and procedures for cumulating effects 
from substances found to have a common mechanism on EPA's web site at 
http://www.epa.gov/pesticides/cumulative/.

[[Page 43530]]

D. Safety Factor for Infants and Children

    1.In general. Section 408 of FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rat or rabbit fetuses to in utero exposure 
to acequinocyl. And, there is no qualitative and/or quantitative 
evidence of increased susceptibility to acequinocyl following pre/
postnatal exposure in a 2-generation reproduction study in rats. There 
is no concern for developmental neurotoxicity resulting from exposure 
to acequinocyl; a DNT study is not required.
    There is an apparent qualitative increase in susceptibility in the 
rat and rabbit developmental studies as indicated by increases in 
resorptions that occurred at the same or higher dose that caused 
maternal toxicity, but the concern is low since:
     The fetal effects were noted in the presence of maternal 
toxicity.
     There are no residual uncertainties for pre- and/or 
postnatal toxicity since the database is complete.
    Effects that could be indicative of neurotoxicity were shown in two 
studies, the 2-generation reproduction study and the subchronic rat 
oral toxicity study. In the 2-generation reproduction study, 
significant reduction in startle response in F2 pups was observed in 
high-dose groups (58.9/69.2 mg/kg/day and 111.2/133.5 mg/kg/day). In 
the subchronic rat oral toxicity study, neurotoxicity signs such as 
decreased motor activity, piloerection, and hunched posture were noted 
at the high dose 252.7/286.0 mg/kg/day.The concern is low since:
     EPA considered these effects as secondary as they were 
observed at very high doses.
     Other functional development tests (such as pupillary 
reflex test at 21 days post partum, an open field exploration test at 
35-48 days post partum and a water-maze test with a learning phase and 
a memory phase at 35-48 days post partum) that were performed on pups 
did not show significant differences as compared to control values even 
at the highest dosage level.
     Acequinocyl is a known Vitamin K antagonist; neurotoxic 
compounds of similar structure were not identified.
    3. Conclusion. There is a complete toxicity database for 
acequinocyl and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures.
    In evaluating whether to retain the 10X SF to protect infants and 
children or to select a different safety factor, EPA considered the 
following factors:
    i. There are no special concerns regarding pre- or postnatal 
toxicity exposure.
    ii. The exposure databases (food and drinking water) are complete 
and/or employ conservative assumptions.
    iii. There is no residential exposure.
    iv. The risk assessments cover or approximate all the metabolites 
and degradates of concern.
    v. The assessments do not underestimate the potential risk for 
infants and children.
    vi. The toxicity database is complete.
    Therefore, it is concluded that 1X is adequate to protect 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 EECs. DWLOC values are 
not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food and residential 
uses. In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)]. This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Acequinocyl is not expected to pose an acute risk 
because no acute effects were observed in the submitted studies.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
acequinocyl from food will utilize 4.2% of the cPAD for the U.S. 
population, 14% of the cPAD for all infants less than 1 year old, and 
23 % of the cPAD for children 1-2 years old. There are no residential 
uses for acequinocyl that result in chronic residential exposure to 
acequinocyl. In addition, there is potential for chronic dietary 
exposure to acequinocyl 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 
Table 4 of this unit:

[[Page 43531]]



              Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Acequinocyl
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        0.027          4.2         0.24        0.003          910
------------------------------------------------
All infants <=1year old                                0.027           14         0.24        0.003          230
------------------------------------------------
Children 1-2 years old                                 0.027           23         0.24        0.003          210
------------------------------------------------
Children 3-5 years old                                 0.027           15         0.24        0.003          230
------------------------------------------------
Children 6- 12 years old                               0.027          6.5         0.24        0.003          250
------------------------------------------------
Youth 13-19 years old                                  0.027          3.2         0.24        0.003          780
------------------------------------------------
Adults 20-49 years old                                 0.027          2.1         0.24        0.003          920
------------------------------------------------
Females 13-19 years old                                0.027          2.3         0.24        0.003          790
------------------------------------------------
Adults 50+ yeas old                                    0.027          2.4         0.24        0.003          920
----------------------------------------------------------------------------------------------------------------

    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).
    Acequinocyl is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Acequinocyl is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    5. Aggregate cancer risk for U.S. population. Acequinocyl is 
classified as not likely to be carcinogenic to humans and thus is not 
expected to pose a cancer risk.
    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 acequinocyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Method validation data support the following two plant methods and 
a livestock method: A high-performance liquid chromatography (HPLC)/
mass spectrometry (MS)/MS method (Morse Laboratories Method 
Meth-133, revision 3) for determining residues of 
acequinocyl and acequinocyl-OH in/on fruit commodities; an HPLC/MS/MS 
method (Morse Laboratories Method Meth-135) for determining 
residues of acequinocyl and acequinocyl-OH in/on almonds hulls and nut 
meats; and an HPLC/MS/MS method (Morse Laboratories Method 
Meth-139, Revision 2) for determining residues of 
acequinocyl and acequinocyl-OH in fat, milk, meat, and meat-by-
products.
    Methods Meth-135 and Meth-133, Revision 
3 have each undergone successful independent laboratory 
validation (ILV) trials. An ILV is not required for Method 
Meth-139, Revision2 because the aforementioned ILV's 
should be sufficient to cover this method based on the similarity of 
all three methods.
    Based on the available method validation data, these methods are 
adequate for collecting residue data in/on livestock commodities, milk, 
pome and citrus fruit commodities, strawberries, and tree nuts. 
Additional confirmatory methods for plants and livestock and 
specificity testing of the analytical enforcement methods for plants 
and livestock are required as conditions of registration. The validated 
LOQ for both acequinocyl and acequinocyl-OH is 0.01 ppm in/on each 
plant and livestock commodity, with the exception of citrus oil. The 
LOQ for each analyte in citrus oil is 0.5 ppm.
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected].

B. International Residue Limits

    There are no established or proposed Codex, Canadian, or Mexican 
maximum residue limits (MRLs) for acequinocyl.

C. Conditions

    The following information must be submitted as conditions for 
product registration related to these tolerances: the registrant will 
be required to submit additional confirmatory enforcement analytical 
methods and specificity testing for plants and livestock; a confined 
rotational crop study; and a new livestock storage stability study.

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
acequinocyl and its metabolite 2-dodecyl-3-hydroxy-1,4-naphthoquinone 
expressed as acequinocyl equivalents, in or on almond, pistachio, and 
fat and liver of cattle, goat, horse and sheep at 0.02 ppm; on almond 
hulls at 2.0 ppm; wet apple pomace at 1.0 ppm; fruit, citrus, group 10 
at 0.2 ppm; citrus oil at 30 ppm; and fruit, pome, group 11 and 
strawberry at 0.40 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new

[[Page 43532]]

section 408(d) of FFDCA, as was provided in the old sections 408 and 
409 of FFDCA. However, the period for filing objections is now 60 days, 
rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0141in 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 September 20, 
2004.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ Street NW, 
Washington, DC. The Office of the Hearing Clerk is open from 8 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the Office of the Hearing Clerk is (202) 5646255-.
    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 PIRIB for its inclusion in 
the official record that is described in ADDRESSES. Mail your copies, 
identified by docket ID number OPP-2004-0141, 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 PIRIB 
described in ADDRESSES. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. 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

[[Page 43533]]

have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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


    Dated: July 1, 2004.

James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.599 is added to subpart C to read as follows:


Sec.  180.599  Acequinocyl; tolerances for residues.

    (a) General. Tolerances for combined residues of the insecticide 
acequinocyl, 2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione, and its 
metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, expressed as 
acequinocyl equivalents in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond.....................................................         0.02
Almond, hulls..............................................          2.0
Apple, wet pomace..........................................          1.0
Cattle, fat................................................         0.02
Cattle, liver..............................................         0.02
Citrus, oil................................................           30
Fruit, citrus, group 10....................................         0.20
Fruit, pome, group 11......................................         0.40
Goat, fat..................................................         0.02
Goat, liver................................................         0.02
Horse, fat.................................................         0.02
Horse, liver...............................................         0.02
Pistachio..................................................         0.02
Sheep, fat.................................................         0.02
Sheep, liver...............................................         0.02
Strawberry.................................................         0.40
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 04-16213 Filed 7-20-04; 8:45 am]
BILLING CODE 6560-50-S