FR Doc 05-15523

[Federal Register: August 10, 2005 (Volume 70, Number 153)]
[Rules and Regulations]
[Page 46419-46428]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10au05-6]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0139; FRL-7724-8]

Aminopyralid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for free and conjugated
residues of aminopyralid in or on grass and wheat commodities; and
residues of aminopyralid in or meat; fat and meat byproducts, excluding
kidney; of cattle, goat, and sheep, and milk. Dow AgroSciences, LLC
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 10, 2005. Objections and
requests for hearings must be received on or before October 11, 2005.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under docket
identification (ID) number OPP-2004-0139. 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 S. Bell St.,
Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The docket telephone
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: JoanneMiller, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6224; e-mail address: miller.joanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; 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/.

To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/
.

II. Background and Statutory Findings

In the Federal Register of June 2, 2004 (69 FR 31106-31110) (FRL-
7359-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C.

[[Page 46420]]

346a(d)(3), announcing the filing of a pesticide petition (PP 4F6827,
incorrectly stated as 7F4851) by Dow AgroSciences, LLC, 9330 Zionsville
Rd., Indianapolis, IN 46268. The petition requested that 40 CFR part
180 be amended by establishing a tolerance for combined residues of the
herbicide aminopyralid (XDE-750): 4-amino-3,6-dichloropyridine-2-
carboxylic acid and its glucose conjugate, expressed as total parent in
or on grass forage at 25 parts per million (ppm), grass hay at 65 ppm,
wheat forage at 2 ppm, wheat hay at 4 ppm, wheat grain at 0.05 ppm,
wheat straw at 0.5 ppm, wheat bran at 0.1 ppm, wheat middlings at 0.02
ppm, wheat shorts at 0.05 ppm, wheat flour at 0.01 ppm, wheat germ at
0.02 ppm, wheat aspirated grain fractions at 0.5 ppm. Tolerances of the
parent, aminopyralid (free) were also proposed for milk at 0.02 ppm,
cream at 0.02 ppm, edible animal tissues except kidney at 0.05 ppm, and
kidney at 1.0 ppm. That notice included a summary of the petition
prepared by Dow AgroSciences, LLC, the registrant.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for free and conjugated residues;
of aminopyralid in or on grass, forage at 25 ppm; grass, hay at 50 ppm;
aspirated grain fractions at 0.2 ppm; wheat, bran at 0.1 ppm; wheat ,
forage at 2.0 ppm; wheat, grain at 0.04 ppm; wheat, hay at 4.0 ppm;
wheat, straw at 0.25 ppm; and for a tolerance for residues of
aminopyralid per se in or on cattle, fat at 0.02 ppm; cattle, meat at
0.02 ppm; cattle, meat byproducts, except kidney at 0.02 ppm; cattle,
kidney at 0.3 ppm; goat, fat at 0.02 ppm; goat, meat at 0.02 ppm; goat,
meat byproducts, except kidney at 0.02 ppm; goat, kidney at 0.3 ppm;
horse, fat at 0.02 ppm; horse, meat at 0.02 ppm; horse, meat
byproducts, except kidney at 0.02 ppm; horse, kidney at 0.3 ppm; sheep,
fat at 0.02 ppm; sheep, meat at 0.02 ppm; sheep, meat byproducts,
except kidney at 0.02 ppm; sheep,kidney at 0.3 ppm; and milk at 0.03
ppm. EPA's assessment of exposures and risks associatedwith
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 aminopyralid 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.
Studies were performed using aminopyralid technical acid (XDE-750)
and a formulation (GF-871) consisting of triisopropanolamine salt of
aminopyralid (XDE-750 TIPA). Doses (Table 1 and Table 2 of this unit)
are expressed as acid equivalents for all studies regardless of the
material administered to test animals.

Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
Guideline No. Study type Results
----------------------------------------------------------------------------------------------------------------
870.3100 2001 13-Week feeding--rat NOAEL = 500 milligrams/kilogram/day (mg/kg/
(XDE-750) with 4 week day) for males (M) and 1,000 mg/kg/day for
recovery period females (F)
LOAEL M = 1,000 mg/kg/day based on
hyperplasia of mucosal epithelium of the
ileum and cecum.
F = not determined
----------------------------------------
870.3100 2004 13-Week feeding--rat NOAEL = 520 mg/kg/day
(GF-871)................. LOAEL = mg/kg/day: not determined
----------------------------------------
870.3100 2001 13-Week feeding-- NOAEL = 1,000 mg/kg/day
mouse LOAEL = mg/kg/day: not determined
(XDE-750)................
----------------------------------------
870.3200 2002 28-Day dermal--rat Systemic:
(XDE-750)................ NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined
Dermal:
NOAEL = M= 100 mg/kg/day
F = 1,000 mg/kg/day
LOAEL = M = 500 mg/kg/day, based on
histopathological changes (slight epidermal
hyperplasia
F= not determined
----------------------------------------

[[Page 46421]]

870.3150 2002 13-Week feeding--dog NOAEL = M = 282 mg/kg/day
(XDE-750)................ F = 232 mg/kg/day
LOAEL = M = 1,070 mg/kg/day
F = 929 mg/kg/day, based on stomach
histopathology (slight diffuse hyperplasia
and hypertrophy of the mucosal epithelium)
----------------------------------------
870.3700 2002 Developmental tox-- Maternal:
rabbit NOAEL = 250 mg/kg/day
(XDE-750)................ LOAEL = 500 mg/kg/day, based on decrease in
body weight (GD 7-10), decreased food
consumption, incoordinated gait (23/26),
and ulcers and erosions of the stomach.
Developmental:
NOAEL = 500 mg/kg/day
LOAEL = (mg/kg/day) not determined
----------------------------------------
870.3700 2004 Developmental tox-- Maternal:
rabbit NOAEL = 104 mg/kg/day
(GF-871)................. LOAEL = 260 mg/kg/day, based on severe
inanition and body weight loss, decreased
fecal output, and mild incoordinated gait
Developmental:
NOAEL = 260 mg/kg/day
LOAEL = 520 mg/kg/day, based on decreased
fetal body weight.
----------------------------------------
870.3700 2001 Developmental tox-- Maternal:
rat NOAEL = 1,000 mg/kg/day
(XDE-750)................ LOAEL = (mg/kg/day) not determined
Developmental:
NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined
----------------------------------------
870.3700 2004 Developmental tox-- Maternal:
rat NOAEL = 520 mg/kg/day
(GF-871)................. LOAEL = mg/kg/day, not determined
Developmental:
NOAEL = 520 mg/kg/day
LOAEL = (mg/kg/day) not determined
----------------------------------------
870.3800 2003 2-Generation Parental/Systemic:
reproduction--rat NOAEL = 1,000 mg/kg/day
(XDE-750)................ LOAEL = (mg/kg/day) not determined
Reproductive:
NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined
Offspring:
NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined.
----------------------------------------
870.4100 2003 1-Year feeding--dogs NOAEL = M = 99 mg/kg/day
(XDE-750)................ F = 93 mg/kg/day
LOAEL = M = 967 mg/kg/day
F = 1038 mg/kg/day, based on thickening of
stomach mucosa (F), and stomach
histopathology in all animals (slight
diffuse hyperplasia and hypertrophy of the
mucosa epithelium, slight lymphoid
hyperplasia of the gastric mucosa and very
slight/slight chronic mucosal
inflammation).
----------------------------------------
870.4200 2003 18-Month NOAEL = M = 1,000 mg/kg/day
carcinogenicity--mice LOAEL = (mg/kg/day) not determined
(XDE-750)................
----------------------------------------
870.4300 2004 2-Year NOAEL = 50 mg/kg/day
carcinogenicity--rats LOAEL = 500 mg/kg/day based on cecal
(XDE-750)................ enlargement, slight mucosal hyperplasia (M)
and slightly decreased body weights.
----------------------------------------
870.5100 2004 Bacterial reverse Negative
mutation assay
(XDE-750)................
----------------------------------------
870.5100 2004 Bacterial reverse Negative
mutation assay
(GF-871).................
XDETIPA..................
----------------------------------------

[[Page 46422]]

870.5300 2004 In vitro mammalian Negative
cell gene mutation test
----------------------------------------
870.5300 2004 In vitro mammalian Negative
cell gene mutation test
(GF-871).................
----------------------------------------
870.5375 2004 In vitro mammalian XDE induced chromosome aberations, but only
cell chromosome at cytotoxic concentrations, the
aberration test clastogenic response was induced secondary
(XDE-750)................ to toxicity.
----------------------------------------
870.5375 2004 In vitro Mammalian Negative
cell chromosome
aberration test
(GF-871).................
----------------------------------------
870.5395 2002 Mammalian Negative
erythrocyte micronucleus
test (XDE-750)
----------------------------------------
870.5395 2004 Mammalian Negative
erythrocyte micronucleus
test (GF-871)
----------------------------------------
870.6200 Acute neurotoxicity NOAEL = 1,000 mg/kg/day
screening battery LOAEL = 2,000 mg/kg/day based on fecal
(XDE-750)................ soiling in M and urine soiling in F.
----------------------------------------
870.6200 Chronic neurotoxicity-- NOAEL = 1,000 mg/kg/day
rat (XDE-750) LOAEL = (mg/kg/day) not determined.
----------------------------------------
870.7485 2004 Metabolism and Recovery after 168 hrs: 96% in low dose
pharmacokinetics--rat (urine-50%, feces- 43%, tissues-0.1%, cage
(XDE-750)................ wash-3%), 95% in high dose (urine-41%,
feces-43%, tissues-1%, caged wash- 10%),
and 95% in the repeated low dose (urine-
59%, feces- 33%, tissues-0.1%, cage wash-
3%). XDE-750 represented >=96% of
administered dose (AD) in urine and 100% AD
in feces. Three unknown components (>=4%)
found in urine were also found in dose
formulations.
----------------------------------------
Non-guideline Triisopropanolamine \14\C-XDE-750 and \14\C-XDE-750-TIPA, when
Salt, Dissociation and administered orally to rats, were
Metabolism in Maile bioequivalent in terms of absorption,
Fischer 344--rats distribution, metabolism, and excretion of
(XDE-750)................ the amino-dichloro-picolinate portion of
the molecule(s)
----------------------------------------------------------------------------------------------------------------

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 UFs 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 UFs 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

[[Page 46423]]

occurrence of additional cancer cases (e.g., risk). An example of how
such a probability risk is expressed would be to describe the risk as
one in one hundred thousand (1 X 10^-\5\), one in a million
(1 X 10^-\6\), or one in ten million (1 X 10^-\7\).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated.
A summary of the toxicological endpoints for aminopyralid used for
human risk assessment is shown in Table 2 of this unit:

Table 2.--Summary of Toxicological Doses and Endpoints for Chemical for Use in Human Risk Assessments
----------------------------------------------------------------------------------------------------------------
Special FQPA SF and
Exposure scenario Dose used in risk level of concern for Study and toxicological
assessment, UF risk assessment effects
----------------------------------------------------------------------------------------------------------------
Acute dietary No appropriate
(General population, including toxicological endpoint
infants and children). attributable to a
single exposure was
identified in the
available toxicology
studies.
--------------------------------------
Chronic dietary NOAEL= 50 mg/kg/day cPAD= cRfd/FQPA SF Chronic toxicity/
(All populations).................... UF= 100............... cPAD= 0.5 mg/kg/day... carcinogenicity study
Chronic RfD=0.5 mg/kg/ LOAEL= 500mg/kg/
day. daybased on cecal
enlargement, slight
mucosal hyperplasia in
males and slightly
decreased body
weights.
--------------------------------------
Incidental oral NOAEL= 104 mg /kg/day Residential LOC for MOE Developmental rabbit
Short-term (1[dash]30 days)......... = 100 study (GF-871)
Occupational LOC for LOAEL=260 mg/kg/
MOE = 100. daybased on severe
inanition (exhaustion
due to lack of food)
and body weight loss,
decreased fecal
output, and mild
incoordinated gait.
--------------------------------------
Incidental oral NOAEL = 104 mg /kg/day Residential LOC for MOE Developmental rabbit
Intermediate-term (1-6 months)....... = 100 study (GF-871)
Occupational LOC for LOAEL=260 mg/kg/day
MOE = 100. based on severe
inanition (exhaustion
due to lack of food)
and body weight loss,
decreased fecal
output, and mild
incoordinated gait.
--------------------------------------
Dermal N/A N/A No endpoint identified
Short-term (1-30 days).............. for this group.
No absorption study
available.
No systemic toxicity
seen at the limit dose
(1,000 mg/kg/day) in
the 28-day dermal
toxicity study in
rats.
--------------------------------------
Dermal N/A N/A No endpoint identified
Intermediate-term (1-6 months)...... for this group.
No absorption study
available.
No systemic toxicity
seen at the limit dose
(1,000 mg/kg/day) in
the 28-day dermal
toxicity study in
rats.
--------------------------------------
Dermal N/A N/A No endpoint identified
Long-term (> 6 months).............. for this group.
No absorption study
available.
No systemic toxicity
seen at the limit dose
(1,000 mg/kg/day) in
the 28-day dermal
toxicity study in
rats.
--------------------------------------
Inhalation NOAEL = 104 mg /kg/day Residential LOC for MOE Developmental rabbit
Short-term (1-30 days)............... = 100 study (GF-871)
Occupational LOC for LOAEL = 260 mg/kg/day
MOE = 100. based on severe
inanition (loss of
vitality due to lack
of food) and body
weight loss, decreased
fecal output, and mild
incoordinated gait.
--------------------------------------
Inhalation NOAEL = 104 mg /kg/day Residential LOC for MOE Developmental rabbit
Intermediate-term (1-6 months)....... = 100 study (GF-871)
Occupational LOC for LOAEL=260 mg/kg/day
MOE = 100. based on severe
inanition (loss of
vitality due to lack
of food) and body
weight loss, decreased
fecal output, and mild
incoordinated gait.
--------------------------------------
Inhalation N/A N/A N/A
Long-term (> 6 months)..............
--------------------------------------
Cancer Classification: There was no treatment related increase in tumor
(Oral, dermal, inhalation)........... incidence when compared to control. This chemical is not likely to be a
carcinogen.
----------------------------------------------------------------------------------------------------------------
LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD =
reference dose, MOE = margin of exposure, LOC = level of concern, N/A = Not Applicable

[[Page 46424]]

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Currently, no
tolerances have been established for the residues of aminopyralid, in
or on any raw agricultural commodity. Risk assessments were conducted
by EPA to assess dietary exposures from aminopyralid 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 1-day or
single exposure. An endpoint of concern attributable to a single dose
of aminopyralid was not identified. Therefore, an acute dietary
exposure assessment was not conducted.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the Lifeline\TM\ Model Version 2.0 software 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. This risk assessment assumed that 100% crop treated for
all food and feed commodities and tolerance level residues.
The dietary exposure was based on residues of aminopyralid in or on
grass and wheat commodities treated with formulations of its
triisopropanolammonium (TIPA) salt and potential drinking water
exposure. Total dietary exposures for the U.S. population and all
subpopulations were less than 0.0013 mg/kg/day.
iii. Cancer. Aminopyralid is classified as ``not likely to be
carcinogenic to humans'' based on the lack of evidence for
carcinogenicity in mice and rats. Therefore, a quantitative cancer
exposure assessment was not conducted.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must pursuant
to section 408(f)(1) of FFDCA require that data be provided 5 years
after the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. Following the initial data submission, EPA is authorized
to require similar data on a time frame it deems appropriate. For the
present action, EPA did not rely on anticipated residues or PCT
information.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for aminopyralid 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 aminopyralid.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) to estimate pesticide concentrations in surface
water and the Screening Concentration in Ground Water Modeling System
(SCI-GROW), which predicts pesticide concentrations in ground water. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
Aminopyralid is relatively persistent in the environment at
relevant pH's and temperatures. It is rapidly photodegraded in water
under favorable light conditions. Laboratory studies found a half-life
of 0.6 day. In addition to carbon dioxide, there were two major
degradates, oxamic acid and malonamic acid, other degradates were at
least four different 2 and 3 carbon acid amides. Photodegradation is
expected to be a significant route of dissipation for aminopyralid in
the environment in clear shallow surface water. Aminopyralid
photogradades moderately slowly on soil, with half-life of 72.2 days in
one study.
Aminopyralid is mobile in soils and generally is not expected to
bind to aquatic sediments. Based on resultsreported in terrestrial
field dissipation studies, aminopyralid appears to be non-persistent in
the field. No majordegradates were identified.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency estimated environmental
concentrations (EECs), which are the model estimates of a pesticide's
concentration in water. Estimated drinking water concentration (EDWC)
derived from these models are used to quantify drinking water exposure
and risk as a %RfD or %PAD.
Based on the PRZM/EXAMS model, the EECs of aminopyralid for chronic
exposures are estimated to be 1.937 parts per billion (ppb) for surface
water and 0.630 ppb for ground water. The chronic estimated water
concentrations derived from surface water modeling results were
significantly higher than the modeled ground water concentrations, and
therefore protective of potential exposures via ground water sources of
drinking water when incorporated into aggregate exposure estimates. The
aminopyralid EEC's were incorporated into LifeLine\TM\ Model Version
2.0 to determine aggregate pesticide exposures from pesticide residues
in the diet.
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).Aminopyralid has no
pending applications to register any use on residential sites; however,
use of aminopyralid is requested on campgrounds and other natural
recreation areas. Such use could result in post-application incidental
oral exposures for infants and children.
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.''
Aminopyralid is a pyridinecarboxylic acids as are the pesticides
picloram and clopyralid. Although these pesticides share a common
herbicidal mode-of-action (auxinic growth regulation), this auxinic
growth process in plants is not

[[Page 46425]]

present in mammals. No common mode of mammalian toxicity has been
identified for auxinic herbicides. An evaluation of the mammalian
toxicology databases of all three active ingredients for target organ
toxicities indicates that there is no evidence that the same toxic
effect occurs in or at the same organ or tissue by essentially the same
sequence of major biochemical events.
For the purposes of this tolerance action, therefore, EPA has not
assumed that aminopyralid has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.

D. Safety Factor for Infants and Children

1.In general. Section 408 of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for pre-natal and post-natal
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 UFs (safety) 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. Pre-natal and post-natal sensitivity. There is no evidence of
increased qualitative or quantitative susceptibility of the fetuses in
the rat or rabbit developmental toxicity studies (XDE-750 and GF-871)
or in a 2-generation reproduction study (rat) after exposure to
aminopyralid. The toxicology database is complete with respect to pre-
and post-natal toxicity. Therefore, EPA has no residual uncertainty
regarding this finding.
In an acute neurotoxicity study in rats with XDE-750, there were no
treatment-related effects on the Functional Observational Battery
(FOB), motor activity, or neuropathological observations. Clinical
observations of rats in the 2,000 mg/kg/day group revealed a higher
incidence of fecal soiling in males and urine soiling in females
compared to the controls. However, these effects were transient (most
resolving within 3-4 days of treatment) and without gross or
neuropathologic changes. In addition, a chronic neurotoxicity study in
rats did not demonstrate effects that would suggest neurotoxicity. In
developmental toxicity studies in rabbits with aminopyralid (XDE-750
and GF-871) incoordinated gait was observed in males and females in the
mid- and high-dose groups. However this finding was transient, with
complete reversal within 2 hours post-dosing. Incoordinated gait was
not observed in any of the other toxicity studies reviewed. A
developmental neurotoxicity study (DNT) is not recommended based on
these studies.
3. Conclusion. There is a complete toxicity database for
aminopyralid and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures.The FQPA SF was
reduced to 1X, based upon the following: As mentioned above, there is
no quantitative or qualitative evidence of increased susceptibility of
rat and rabbit fetuses to in utero exposure to aminopyralid in
developmental toxicity studies. There is no quantitative or qualitative
evidence of increased susceptibility to aminopyralid following pre-/
post-natal exposure in a 2-generation reproduction study. In addition,
there is no concern for developmental neurotoxicity resulting from
exposure to aminopyralid, and a developmental neurotoxicity study is
not required. Furthermore, the chronic dietary food exposure assessment
assumes 100% crops treated for all commodities. The dietary drinking
water assessment utilizes water concentration values generated by model
and associated modeling parameters which are designed to provide
conservative, health protective, high-end estimates of water
concentrations which will not likely be exceeded. Finally, for the
proposed uses for aminopyralid which result in recreational exposure;
default assumptions, that result in high-end estimates of exposure,
were used.

E. Aggregate Risks and Determination of Safety

The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against EECs. The DWLOC values are not
regulatory standards for drinking water, but 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). 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. When new
uses are added OPP reassesses the potential impacts of residues of the
pesticide in drinking water as a part of the aggregate risk assessment
process.
More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface and ground water EECs are
directly incorporated into the dietary exposure analysis, along with
food. This provides a more realistic estimate of exposure because
actual body weights and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in

[[Page 46426]]

developing drinking water modeling inputs.
1. Acute risk. An endpoint of concern attributable to a single dose
was not identified. Therefore, no acute risk is expected.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
aminopyralid from food plus drinking water will utilize < 1% of the cPAD
for the U.S. population, < 1% of the cPAD for children 1-2 years old ,
and < 1% of the cPAD for children 6-12 years old. There are no
residential uses for aminopyralid that result in chronic residential
exposure to aminopyralid.
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).
Although there will not be any residential uses for aminopyralid,
Dow AgroSciences, LLC has pending applications for use-sites:
Campgrounds and recreational areas. EPA has completed short-term risk
assessment for these use-sites. The risk assessment was for the
potential post-application exposure of infants and children, based on
hand-to-mouth transfer of residues and ingestion of aminopyralid-
contaminated grass and soil. Post-application inhalation exposure is
not expected to occur. For the risk assessment of these incidental
exposures, the NOAEL of 104 mg/kg/day found in the rabbit development
study, was used. The combined exposures from food and drinking water
and these incidental exposures were used to estimate short-term
aggregate risk for infants and children. The Table 3 of this unit gives
the EPA's short-term exposure and risk estimates for aminopyralid,
resulting from potential exposures from food, drinking water and the
recreational uses of aminopyralid.

Table 3.--Short-Term Aggregate Exposure and Risk Estimates for Aminopyralid
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exposure, mg/kg/day
Population subgroup NOAEL, mg/kg/day ------------------------------------------------------------ Aggregate MOE
Dietary Total non-dietary Total aggregate
-------------------------------------------------------------------------------------------------------------------------------------
All infants (< 1 year) 104 0.00052 0.0021 0.00262 40,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 years 104 0.00120 0.0021 0.00330 32,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 3-5 years 104 0.00088 0.0021 0.00298 35,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 6-12 years 104 0.00052 0.0021 0.00262 40,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

The EPA acknowledges that the aggregate exposure and risk estimates
for infants and children are likely overestimates and the coincidence
of such exposures will not be common.
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).
Aminopyralid has no pending registration for any sites that would
result in intermediate-term exposure. While there is potential short-
term exposure from the campgrounds and recreation area uses, there are
no potential intermediate-term (30-180 days) exposures.
5. Aggregate cancer risk for U.S. population. Aminopyralid has not
been shown to be carcinogenic. Therefore, aminopyralid 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 aminopyralid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology, liquid chromotography and
positive ion electrospray tandem spectrometry with limits of
quantitation of 0.01 ppm, is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.

B. International Residue Limits

There are currently no established Codex, Canadian, or Mexican
maximum residue limits for aminopyralid.

C. Conditions

Dow AgroScience, LLC must submit storage stability data for grass
forage and hay reflecting up to approximately 15 months of frozen
storage.

D. Public Comments

One comment was received. B. Sachau objected to the proposed
tolerance because of the amounts of pesticides already consumed and
carried by the American population. The commenter also claimed that
tests conducted with animals have absolutely no validity and are cruel
to the testanimals. EPA has responded to B. Sachau's generalized
comments on numerous previous occasions. (See the Federal Register of
January 7, 2005 (70 FR 1349-1354) (FRL-7691-4) and the Federal Register
of October 29, 2004 (69 FR 63083-63096) (FRL-7681-9)).

V. Conclusion

Therefore, the tolerances are established for residues of
aminopyralid, free and conjugated residues, in or on aspirated grain
fractions at 0.2 ppm; grass, forage at 25 ppm; grass, hay at 50 ppm;
wheat bran at 0.1 ppm; wheat , forage at 2.0 ppm; wheat, grain at 0.04
ppm; wheat, hay at 4.0 ppm; wheat, straw at 0.25 ppm; and tolerances
are established for residues of aminopyralid in or on cattle, fat at
0.02 ppm; cattle, meat at 0.02 ppm; cattle, meat byproducts, except
kidney at 0.02 ppm; cattle, kidney at 0.3 ppm; goat, fat at 0.02 ppm;
goat, meat at 0.02 ppm; goat, meat byproducts, except kidney at 0.02
ppm; goat, kidney at 0.3 ppm; horse, fat at 0.02 ppm; horse, meat at
0.02 ppm; horse, meat byproducts, except kidney at 0.02 ppm; horse,
kidney at 0.3 ppm; milk at 0.03 ppm; sheep, fat at 0.02 ppm; sheep,
meat at 0.02 ppm; sheep, meat byproducts,

[[Page 46427]]

except kidney at 0.02 ppm; and sheep, kidney at 0.3 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.

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

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0139 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
11, 2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-0139 to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

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

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

[[Page 46428]]

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 27, 2005.
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 180.610 is added to subpart C to read as follows:

Sec. 180.610 Aminopyralid; tolerances for residues.

(a ) General. (1) Tolerances are established for free and
conjugated residues of the herbicide, aminopyralid (2-pyridine
carboxylic acid, 4-amino-3,6-dichloro-) calculated as aminopyralid in
or on:

(2) Tolerances are established for residues of the herbicide
aminopyralid in or on:

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat.................................... 0.02
Cattle, meat................................... 0.02
Cattle, meat byproducts, excluding kidney...... 0.02
Cattle, kidney................................. 0.3
Goat, fat...................................... 0.02
Goat, meat..................................... 0.02
Goat, meat byproducts, excluding kidney........ 0.02
Goat, kidney................................... 0.3
Horse, fat..................................... 0.02
Horse, meat.................................... 0.02
Horse, meat byproducts, excluding kidney....... 0.02
Horse, kidney.................................. 0.3
Milk........................................... 0.03
Sheep, fat..................................... 0.02
Sheep, meat.................................... 0.02
Sheep, meat byproducts, excluding kidney....... 0.02
Sheep, kidney.................................. 0.3
------------------------------------------------------------------------

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

[FR Doc. 05-15523 Filed 8-9-05; 8:45 am]

BILLING CODE 6560-50-S