[Federal Register: July 27, 2005 (Volume 70, Number 143)]
[Rules and Regulations]
[Page 43298-43309]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jy05-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0038; FRL-7726-8]
2,4-D; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of 2,4-
dichlorophenoxyacetic acid (2,4-D) in or on hop, soybean, and wild rice
. Interregional Research Project Number 4 (IR-4) and the Industry Task
Force II on 2,4-D Research Data (Task Force) and its registrant members
and affiliates on behalf of IR-4 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 July 27, 2005. Objections and
requests for
[[Page 43299]]
hearings must be received on or before September 26, 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-2005-0038. 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: Joanne I. Miller, Registration
Division (7505C), Office of Pesticide Programs, Environmental
ProtectionAgency, 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 March 14, 2002 (67 FR 11480) (FRL-6826-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6E4636) by Interregional Research Project Number 4 (IR-4), 681 U.S.
Highway 1 South, North Brunswick, NJ 08902-3390. The petition
requested that 40 CFR 180.142 be amended by establishing a tolerance
for residues of the herbicide 2,4-D in or on wild rice at 0.1 parts per
million (ppm). That notice included a summary of the petition prepared
by Rhone-Poulenc Ag Co., the registrant. In the Federal Register of
December 15, 2004 (69 FR 75066) (FRL-7688-2), EPA issued a notice
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide petition (PP 4E3060) by the Task
Force and its registrant members and affiliates, 1900 K St., NW.,
Washington, DC 20006 on behalf of IR-4. The petition requested that 40
CFR 180.142(a)(11) be amended by removing the expiration date of
December 31, 2004 for 2,4-D in or on the raw agricultural commodity
soybean seed at 0.02 ppm. That notice included a summary of the
petition prepared by the Task Force, the petitioner. In the Federal
Register of April 13, 2005 (70 FR 19442) (FRL-7707-9), EPA issued a
notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide petition (PP 2E6352) by IR-4, 681
U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The
petition requested that 40 CFR part 180 be amended by establishing a
tolerance for residues of the herbicide 2,4-D in or on hop at 0.05 ppm.
That notice included a summary of the petition prepared by IR-4, the
petitioner. Two comments were received in response to the notices of
filing and they are addressed in Unit IV.D.
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 residues of 2,4-D on hop at
0.05 ppm, soybean at 0.02 ppm, and wild rice at 0.1 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.
[[Page 43300]]
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by 2,4-D 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.
Table 1.--2,4-D Subchronic, Chronic, and Other Toxicity
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Guideline No. Study type Results
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870.3100 90-Day oral toxicity-- NOAEL = 15 milligrams/kilogram/day (mg/kg/
rodents--rats day)
LOAEL = 100 mg/kg/day based on decreases
in body weight/gain, alterations in
hematology and clinical chemistry
(decreased T3 and T4) parameters, and
cataract formation in females.
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870.3150 90-Day oral toxicity-- NOAEL = 1 mg/kg/day
nonrodents--beagle dogs LOAEL = 3 mg/kg/day based on decreased
body weight/body-weight gain and food
consumption (males), alterations in
clinical chemistry parameters (increased
blood urea nitrogen (BUN) (both sexes),
creatinine (males)), and decreased testis
weight in males.
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870.3150 90-Day oral toxicity-- NOAEL = 1 mg/kg/day
nonrodents--beagle dogs LOAEL = 3.75 mg/kg/day based on decreased
body-weight gain (both sexes) and food
consumption (males), as well as
alterations in clinical chemistry
parameters (increased BUN, creatinine,
and alanine aminotransferase) in both
sexes, and decreased testes weight and
slightly higher incidence of
hypospermatogenesis/juvenile testis and
inactive/juvenile prostate were observed.
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870.3200 21-Day dermal toxicity NOAEL = 1,000 mg/kg/day
LOAEL = >1,000 mg/kg/day based on no
adverse effects at the limit dose.
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870.3700 Prenatal developmental-- Maternal:
rodents--rats NOAEL = 25 mg/kg/day
LOAEL = 75 mg/kg/day based on decreased
body-weight gains. Survival was not
affected by treatment.
Developmental:
NOAEL = 25 mg/kg/day
LOAEL = 75 mg/kg/day based on skeletal
abnormalities.
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870.3700 Prenatal developmental-- Maternal:
nonrodents--rabbits NOAEL = 30 mg/kg/day
LOAEL = 90 mg/kg/day based on clinical
signs (ataxia, decreased motor activity,
loss of righting reflex, cold
extremities), abortion (2), decreased
body-weight gains. Survival was not
affected by treatment.
Developmental:
NOAEL = 30 mg/kg/day
LOAEL = 90 mg/kg/day based on abortions.
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870.3800 Reproduction and fertility Parental/Systemic:
effects--rats NOAEL = 5 mg/kg/day
LOAEL = 20 mg/kg/day based on decreased
female body weight/body-weight gain (F1)
and renal tubule alteration in males (F0
and F1).
Reproductive:
NOAEL = 20 mg/kg/day
LOAEL = 80 mg/kg/day based on an increase
in gestation length (F0 females producing
F1b pups).
Offspring:
NOAEL = 5 mg/kg/day
LOAEL = 20 mg/kg/day based on decreased
pup body weight (F1b). At 80 mg/kg/day,
there was an increase in dead pups.
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870.4100 Chronic toxicity--dogs NOAEL = 1 mg/kg/day
LOAEL = 5 mg/kg/day based on decreased
body-weight gain (both sexes) and food
consumption (females), as well as
alterations in clinical chemistry
parameters (increased BUN, creatinine,
and alanine aminotransferase, decreased
glucose) in both sexes, and decreased
brain weight in females, and
histopathological lesions in liver and
kidneys.
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[[Page 43301]]
870.4300 Combined chronic toxicity NOAEL = 5 mg/kg/day
carcinogenicity --rodents LOAEL = 75 mg/kg/day based on decreased
(rats) body-weight gain (females) and food
consumption (females), alterations in
hematology (decreased red blood cells
(RBC), hematocrit (HCT), and hemoglobin
(HGB) (females), platelets (both sexes))
and clinical chemistry parameters
(increased creatinine (both sexes),
alanine and aspartate aminotransferases
(males), alkaline phosphatase (both
sexes), decreased T4 (both sexes),
glucose (females), cholesterol (both
sexes), and triglycerides (females)),
increased thyroid weights (both sexes at
study termination), and decreased testes
and ovarian weights. At highest dose
tested (HDT), there were microscopic
lesions in the eyes, liver, adipose
tissue, and lungs.
There was no evidence of carcinogenicity
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870.4300 Carcinogenicity--mice NOAEL = 5 mg/kg/day
LOAEL = 62/150 mg/kg/day based on an
increased absolute and/or relative kidney
weights and an increased incidence of
renal microscopic lesions.
There was no evidence of carcinogenicity
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870.5265 Gene mutation Ames, reverse No evidence of bacterial mutation in S.
mutation typhimurium strains TA1535, TA1537,
TA1538, TA98, TA100, with and without S9.
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870.5395 In vivo erythrocyte micro- No significant increase in bone marrow
nucleus assay Institute polychromatic erythrocytes.
for Cancer Research (ICR)
mice
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870.5375 Cytogenetics in vitro No evidence of increased chromosome
chromosome aberration aberrations in human lymphocytes.
(human lymphocytes)
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870.5385 Cytogenetics in vivo Equivocal (+ at top 2 doses, but results
chromosome aberration were similar to dimethyl sulfoxide (DMSO)
(Wistar rat bone marrow) control).
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870.5450 Other effects No evidence of induction of unscheduled
(Unscheduled DNA synthesis DNA synthesis.
assay).
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870.6200 Acute neurotoxicity NOAEL = 67 mg/kg/day
screening battery--rats LOAEL = 227 mg/kg/day based on an
increased incidence of incoordination and
slight gait abnormalities (described as
forepaw flexing or knuckling) and
decreased total motor activity.
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870.6200 Subchronic neurotoxicity NOAEL = 75 mg/kg/day
screening battery--rats LOAEL = 150 mg/kg/day based on increased
forelimb grip strength.
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870.7485 Metabolism and 85.5%-93.7% of dose eliminated in urine;
pharmacokinetics--rats 3.6%-10.5% of dose eliminated via the
feces; no differences noted between the
sexes; at the high-dose level, it appears
that a nonlinear region (decreased
clearance) is being reached in the
disposition of 2,4-D.
Parent 2,4-D was the major metabolite
found in urine (72.9%-90.5% of the oral
dose), with small amounts of
uncharacterized compounds (0.6%-1.3% and
0%-0.7%) being found in the urine.
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870.7600 Dermal penetration 5.8%
----------------------------------------------------------------------------------------------------------------
Special studies Study designed specifically to compare the
pharmacokinetics/ rat and dog with respect to the excretion
metabolism study (single of 2,4-D and the relevancy of the dog
exposure) Fischer 344 data for risk assessment.
ratand beagle dogs
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B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, 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 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
[[Page 43302]]
and children primarily as a result of 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 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 2,4-D used for human
risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for 2,4-D 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
traditional UF
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Acute dietary NOAEL = 25 mg/kg/day Special FQPA SF = 1 Rat developmental
(Females 13-50 years of age)......... UF = 1,000............ aPAD = acute RfD/ toxicity study
Acute RfD = 0.025 mg/kg/ Special FQPA SF = LOAEL = 75 mg/kg/day
day. 0.025 mg/kg/day. based on skeletal
abnormalities.
----------------------------------------------------------------------------------------------------------------
Acute dietary NOAEL = 67 mg/kg/day Special FQPA SF = 1 Acute neurotoxicity
(General population including infants UF = 1,000............ aPAD = acute RfD/ study in rats
and children). Acute RfD = 0.067 mg/kg/ Special FQPA SF = LOAEL = 227 mg/kg/day
day. 0.067 mg/kg/day. based on gait
abnormalities.
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Chronic dietary NOAEL = 5 mg/kg/day Special FQPA SF = 1 Rat chronic toxicity
(All populations).................... UF = 1,000............ cPAD = chronic RfD/ study
Chronic RfD =.......... Special FQPA SF = LOAEL = 75 mg/kg/day
0.005 mg/kg/day........ 0.005 mg/kg/day. based on decreased
body-weight gain
(females) and food
consumption (females),
alterations in
hematology (decreased
RBC, HCT, and HGB
(females), platelets
(both sexes)) and
clinical chemistry
parameters (increased
creatinine (both
sexes), alanine and
aspartate
aminotransferases
(males), alkaline
phosphatase (both
sexes), decreased T4
(both sexes), glucose
(females), cholesterol
(both sexes), and
triglycerides
(females)).
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Short-term incidental oral Oral study LOC for MOE = 1,000 Rat developmental
(1 to 30 days)....................... NOAEL = 25 mg/kg/day.. (Residential).......... toxicity study
(Residential)........................ LOAEL = 75 mg/kg/day
based on decreased
maternal body-weight
gain.
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Intermediate-term incidental oral Oral study LOC for MOE = 1,000 Subchronic oral
(1 to 6 months)...................... NOAEL = 15 mg/kg/day.. (Residential).......... toxicity--rat
(Residential)........................ LOAEL = 100 mg/kg/day
based on decreased
body weight/body-
weight gain,
alterations in some
hematology (decreased
platelets (both
sexes)) and clinical
chemistry (decreased
T3 (females) and T4
(both sexes))
parameters, and
cataract formation.
----------------------------------------------------------------------------------------------------------------
Short-term dermal Oral study LOC for MOE = 1,000 Rat developmental
(1 to 7 days)........................ NOAEL = 25 mg/kg/day.. (Residential)......... toxicity study
(Residential)........................ (Dermal absorption rate LOAEL = 75 mg/kg/day
= 10 %). based on decreased
maternal body-weight
gain and skeletal
abnormalities.
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[[Page 43303]]
Intermediate-term dermal Oral study LOC for MOE = 1,000 Subchronic oral
(1 week to several months)........... NOAEL = 15 mg/kg/day... (Residential).......... toxicity--rat
(Residential)........................ (Dermal absorption rate LOAEL = 100 mg/kg/day
= 10 %. based on decreased
body weight/body-
weight gain,
alterations in some
hematology (decreased
platelets (both
sexes)) and clinical
chemistry (decreased
T3 (females) and T4
(both sexes))
parameters, and
cataract formation.
----------------------------------------------------------------------------------------------------------------
Long-term dermal Oral study LOC for MOE = 1,000 Rat chronic toxicity
(Several months to lifetime)......... NOAEL = 5 mg/kg/day... (Residential).......... study
(Residential)........................ (Dermal absorption rate LOAEL = 75 mg/kg/day
= 10 % when based on decreased
appropriate). body-weight gain
(females) and food
consumption (females),
alterations in
hematology (decreased
RBC, HCT, and HGB
(females), platelets
(both sexes)) and
clinical chemistry
parameters (increased
creatinine (both
sexes), alanine and
aspartate
aminotransferases
(males), alkaline
phosphatase (both
sexes), decreased T4
(both sexes), glucose
(females), cholesterol
(both sexes), and
triglycerides
(females)), increased
thyroid weights (both
sexes at study
termination), and
decreased testes and
ovarian weights.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation Inhalation (or oral) LOC for MOE = 1,000 Rat developmental
(1 to 7 days)........................ study (Residential).......... toxicity study
(Residential)........................ NOAEL = 25 mg/kg/day.. LOAEL = 75 mg/kg/day
(Inhalation absorption based on decreased
rate = 100%). maternal body-weight
gain and skeletal
abnormalities.
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation Inhalation (or oral) LOC for MOE = 1,000 Subchronic oral
(1 week to several months)........... study (Residential).......... toxicity--rat
(Residential)........................ NOAEL = 15 mg/kg/day.. LOAEL = 100 mg/kg/day
(Inhalation absorption based on decreased
rate = 100%). body weight/body-
weight gain,
alterations in some
hematology (decreased
platelets (both
sexes)) and clinical
chemistry (decreased
T3 (females) and T4
(both sexes))
parameters, and
cataract formation.
----------------------------------------------------------------------------------------------------------------
Long-term inhalation Inhalation (or oral) LOC for MOE = 1,000 Rat chronic toxicity
(Several months to lifetime)......... study (Residential).......... study
(Residential)........................ NOAEL = 5 mg/kg/day... LOAEL = 75 mg/kg/day
(Inhalation absorption based on decreased
rate = 100%). body-weight gain
(females) and food
consumption (females),
alterations in
hematology (decreased
RBC, HCT, and HGB
(females), platelets
(both sexes)) and
clinical chemistry
parameters (increased
creatinine (both
sexes), alanine and
aspartate
aminotransferases
(males), alkaline
phosphatase (both
sexes), decreased T4
(both sexes), glucose
(females), cholesterol
(both sexes), and
triglycerides
(females)), increased
thyroid weights (both
sexes at study
termination), and
decreased testes and
ovarian weights.
----------------------------------------------------------------------------------------------------------------
Cancer Not likely to pose a cancer risk based on the lack of carcinogenicity in
(Oral, dermal, inhalation)........... a rat carcinogenicity study and a mouse carcinogenicity study.
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.142) for the residues of 2,4-D, in or on a
variety of raw agricultural commodities, fish, meat, milk, poultry, and
eggs. Risk assessments were conducted by EPA to assess dietary
exposures from 2,4-D in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
In conducting the acute dietary risk assessment EPA used Lifeline
Model Version 2.0 (Lifeline) and the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-FCID, Version
1.33). DEEM incorporates consumption data from United States Department
of Agriculture's (USDA) Continuing
[[Page 43304]]
Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.
Lifeline uses food consumption data from USDA's CSFII from 1994-1996
and 1998. Lifeline uses recipe files contained within the program to
relate raw agricultural commodities (RACs) to foods ``as-eaten.''
Lifeline converts the RAC residues into food residues by randomly
selecting a RAC residue value from the ``user defined'' residue
distribution (created from the residue, percent crop treated (PCT), and
processing factors data), and calculating a net residue for that food
based on the ingredients' mass contribution to that food item. The
following assumptions were made for the acute exposure assessments: For
the acute analyses, tolerance-level residues were assumed for most food
commodities with 2,4-D tolerances except the highest-field trial
residue value was used for citrus commodities, and it was assumed that
all of the crops included in the analysis were treated. One half of the
average Level of Detection (LOD) from Pesticide Data Program (PDP)
monitoring data was used as the milk exposure value because no milk
sample contained detectable 2,4-D residues over several years of PDP.
The PCT data were not used in the acute risk assessment.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used Lifeline and DEEM-FCID, Version 1.33. DEEM
incorporates consumption data from USDA's CSFII, 1994-1996 and 1998.
Lifeline uses food consumption data from the USDA's CSFII from 1994-
1996 and 1998. Lifeline uses recipe files contained within the program
to relate RACs to foods ``as-eaten.'' Lifeline converts the RAC
residues into food residues by randomly selecting a RAC residue value
from the ``user defined'' residue distribution (created from the
residue, PCT, and processing factors data), and calculating a net
residue for that food based on the ingredients' mass contribution to
that food item. The following assumptions were made for the chronic
exposure assessments: For the chronic analyses, tolerance-level
residues were assumed for food commodities with 2,4-D tolerances except
averages of field trial data and processing study factors were used for
small grains, citrus, and sugarcane sugar and molasses; percentage of
crop treated information was used for most commodities; and the highest
observed groundwater monitoring concentration (15 parts per billion
(ppb)) in drinking water is used to calculate the aggregate risk. One
half of the average LOD from PDP monitoring data was used as the milk
exposure value because no milk sample contained detectable 2,4-D
residues over several years of PDP.
iii. 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 will issue such data call-ins
for information relating to anticipated residues as are required by
section 408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of
FFDCA. Such data call-ins will be required to be submitted no later
than 5 years from the date of issuance of this tolerance.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid
basis to show what percentage of the food derived from such crop is
likely to contain such pesticide residue.
Condition 2, that the exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require
registrants to submit data on PCT.
The Agency used PCT information as follows:
Table 3.--Percent Crop Treated (PCT) for Registered 2,4-D Uses
----------------------------------------------------------------------------------------------------------------
Crop Acreage PCT Lbs./acre (ai)
----------------------------------------------------------------------------------------------------------------
Alfalfa 23,704,000 0.6 69,000
----------------------------------------------------------------------------------------------------------------
Almonds 583,000 10 70,000
----------------------------------------------------------------------------------------------------------------
Apples 477,000 36 250,000
----------------------------------------------------------------------------------------------------------------
Apricots 23,0008 8 3,000
----------------------------------------------------------------------------------------------------------------
Asparagus 77,000 15 20,000
----------------------------------------------------------------------------------------------------------------
Barley 5,914,000 43 1,290,000
----------------------------------------------------------------------------------------------------------------
Beans/peas, dry 2,133,000 3 30,000
----------------------------------------------------------------------------------------------------------------
Beans/peas, vegetable 677,000 1.2 8,000
----------------------------------------------------------------------------------------------------------------
Blueberries 62,000 0.5 200
----------------------------------------------------------------------------------------------------------------
Canola/rapeseed 1,281,000 2 11,000
----------------------------------------------------------------------------------------------------------------
Cherries 105,000 24 30,000
----------------------------------------------------------------------------------------------------------------
Corn, field 75,241,000 12 3,660,000
----------------------------------------------------------------------------------------------------------------
[[Page 43305]]
Cotton 13,793,000 3 234,000
----------------------------------------------------------------------------------------------------------------
Cranberries 32,000 9 6,000
----------------------------------------------------------------------------------------------------------------
Fallow, Summer 22,879,000 10 2,003,000
----------------------------------------------------------------------------------------------------------------
Flax 143,000 9 7,000
----------------------------------------------------------------------------------------------------------------
Filberts 31,000 58 35,000
----------------------------------------------------------------------------------------------------------------
Grapefruit 165,000 19 1,100
----------------------------------------------------------------------------------------------------------------
Grapes 1,006,000 2 13,000
----------------------------------------------------------------------------------------------------------------
Hay, other 33,777,000 8 1,824,000
----------------------------------------------------------------------------------------------------------------
Lemons 72,000 1.5 1,100
----------------------------------------------------------------------------------------------------------------
Millet 318,000 23 35,000
----------------------------------------------------------------------------------------------------------------
Nectarines 34,000 10 1,000
----------------------------------------------------------------------------------------------------------------
Oats 4,036,000 19 380,000
----------------------------------------------------------------------------------------------------------------
Oranges 940,000 7 20,000
----------------------------------------------------------------------------------------------------------------
Pasture/rangeland 469,536 5 16,371,000
----------------------------------------------------------------------------------------------------------------
Peaches 158,000 12 25,000
----------------------------------------------------------------------------------------------------------------
Peanuts 1,416,000 4 30,000
----------------------------------------------------------------------------------------------------------------
Pears 70,000 14 15,000
----------------------------------------------------------------------------------------------------------------
Pecans 496,000 5 20,000
----------------------------------------------------------------------------------------------------------------
Pistachios 100,000 5 5,000
----------------------------------------------------------------------------------------------------------------
Potatoes 1,291,000 2 4,000
----------------------------------------------------------------------------------------------------------------
Prunes/plums 151,000 17 25,000
----------------------------------------------------------------------------------------------------------------
Rice 3,231,000 17 527,000
----------------------------------------------------------------------------------------------------------------
Rye 298,000 21 30,000
----------------------------------------------------------------------------------------------------------------
Seed crops 1,383,000 36 275,000
----------------------------------------------------------------------------------------------------------------
Sorghum 9,077,000 16 667,000
----------------------------------------------------------------------------------------------------------------
Soybeans 70,993,000 7 2,410,000
----------------------------------------------------------------------------------------------------------------
Strawberries 47,000 7 5,000
----------------------------------------------------------------------------------------------------------------
Sugarcane 939,000 53 490,000
----------------------------------------------------------------------------------------------------------------
Sunflowers 2,040,000 4 50,000
----------------------------------------------------------------------------------------------------------------
Sweet Corn 678,000 5 15,000
----------------------------------------------------------------------------------------------------------------
Walnuts 229,000 9 40,000
----------------------------------------------------------------------------------------------------------------
Wheat, Spring 18,903,000 4 50,000
----------------------------------------------------------------------------------------------------------------
Wheat, Winter 42,403,000 24 5,140,000
----------------------------------------------------------------------------------------------------------------
Wild rice 26,000 10 600
----------------------------------------------------------------------------------------------------------------
EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available Federal, State, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of five. EPA uses a maximum PCT for acute dietary risk
analysis. The
[[Page 43306]]
maximum PCT figure is the single-maximum value reported overall from
available Federal, State, and private market survey data on the
existing use, across all years, and rounded up to the nearest multiple
of five.
The Agency believes that the three conditions listed Unit
III.C.1.iii. have been met. With respect to Condition 1 of Unit
III.C.1.iii. , PCT estimates are derived from Federal and private
market survey data, which are reliable and have a valid basis. The
Agency is reasonably certain that the percentage of the food treated is
not likely to be an underestimation. As to Conditions 2 and 3 of Unit
III.C.1.iii., regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which 2,4-D may be
applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for 2,4-D 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 2,4-D.
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 Concentration in Ground Water Modeling System
(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.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of 2,4-D for
acute exposures are estimated to be 118 ppb for surface water. The EECs
for chronic exposures are estimated to be 23 ppb for surface water.
Based on actual monitoring of 2,4-D the acute and chronic exposures are
15 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).
2,4-D is currently registered for use on the following residential
non-dietary sites: Turf. The risk assessment was conducted using the
following residential exposure assumptions: Homeowners (or others) may
be exposed to 2,4-D while treating their lawns. All homeowner-use
products are available in liquid or granular form. 2,4-D is applied
using hose-end sprayers, pump sprayers, ready-to-use sprayers,
broadcast spreaders, belly grinders, and hand application, either
before or after seasonal weed emergence, at a rate up to 1.5 lbs./ai.
2,4-D uses in the residential setting include applications to home
lawns. The following scenarios were assessed for residential post
application risks: Toddlers playing on treated turf, adults performing
yard work on treated turf, and adults playing golf on treated turf.
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 2,4-D and any other
substances and 2,4-D does not appear to produce a toxic metabolite
produced by other substances. EPA has also evaluated comments submitted
that suggested there might be a common mechanism among 2,4-D and other
named pesticides that cause brain effects. EPA concluded that the
evidence did not support a finding of common mechanism for 2,4-D and
the named pesticides. For the purposes of this tolerance action,
therefore, EPA has not assumed that 2,4-D 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 website at http://www.epa.gov/pesticides/cumulative/
.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
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. Prenatal and postnatal sensitivity. The toxicity database for
2,4-D includes acceptable developmental and reproductive toxicity
studies. Developmental toxicity studies were conducted in both rats and
rabbits for most 2,4-D forms. There is qualitative evidence of
susceptibility in the rat developmental toxicity study with 2,4-D acid
and DEA salt where fetal effects (skeletal abnormalities) were observed
at a dose level that produced less severe
[[Page 43307]]
maternal toxicity (decreased body-weight gain and food consumption).
There is no evidence of increased (quantitative or qualitative)
susceptibility in the prenatal developmental toxicity study in rabbits
or in the 2-generation reproduction study in rats on 2,4-D. Regarding
the 2,4-D amine salt and ester forms, no evidence of increased
susceptibility (quantitative or qualitative) was observed in the
prenatal developmental toxicity study in rat and rabbits (except for
2,4-D DEA) dosed with any of the amine salts or esters of 2,4-D. There
is evidence of increased susceptibility (qualitative) in the prenatal
developmental study in rabbits for 2,4-D DEA salt. After establishing
developmental toxicity endpoints to be used in the risk assessment with
traditional uncertainty factors (10x for interspecies variability and
10x for intraspecies variability), the Agency has no residual concerns
for the effects seen in the developmental toxicity studies.
3. Conclusion. EPA has concerns with regard to the completeness of
the toxicity database. A developmental neurotoxicity (DNT) study in
rats is required for 2,4-D. The Agency concluded that there is a
concern for developmental neurotoxicity resulting from exposure to 2,4-
D. There is evidence of neurotoxicity, including clinical signs such as
ataxia and decreased motor activity in pregnant rabbits following
dosing during gestation days 6-15 in studies on 2,4-D itself and 2,4-D
amine salts and esters, and tremors in dogs that died on test following
repeat exposure to 2,4-D. Incoordination and slight gait abnormalities
(forepaw flexing or knuckling) were also observed following dosing in
the acute neurotoxicity study with 2,4-D. There is also evidence of
developmental toxicity, as discussed above. In addition, the Agency
determined that a repeat two generation reproduction study using a new
protocol is required to address concerns for endocrine disruption
(thyroid and immunotoxicity measures). Examination of the existing
database does not reveal a basis for concluding that aggregate exposure
to 2,4-D will be safe for infants and children in the absence of the
additional 10X FQPA safety factor. Therefore, the Agency determined
that the 10X FQPA safety factor, in the form of a database uncertainty
factor (UFDB), will be retained.
E. Aggregate Risks and Determination of Safety
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to 2,4-D
will occupy 18% (DEEM) of the aPAD for the U.S. population, 43 %
(Lifeline) of the aPAD for females 13-49 years old, and 31% (DEEM) of
the aPAD for children 1-2 years old.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to 2,4-D
from food and drinking water will utilize 10% (DEEM) of the cPAD for
the U.S. population, 24% (DEEM) of the cPAD for all Infants (< 1 year
old), and 18% (DEEM) of the cPAD for children 1-2 years old. There are
no residential uses for 2,4-D that result in chronic residential
exposure to 2,4-D.
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).
2,4-D is currently registered for use that could result in short-
term residential exposure. Short-term aggregate risks were calculated
only for females 13-49 and children 1-6 because these population
subgroups have the highest exposure and are protective of the other
subgroups. The short-term aggregate MOEs are presented in Table 4 of
this unit and indicate that the short-term risks are not of concern
because the MOEs equal or exceed the target MOE of 1,000.
Table 4.--Aggregate Short-Term MOEs Including Turf Exposures for 2,4-D
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic
Estimated
Turf application Chronic food Short-term turf Drinking Water Drinking water Aggregate
Population subgroup rate (lbs. (ae)/ exposure (mg/ exposure (mg/kg/ Concentration exposure (mg/ exposure (mg/ Aggregate MOE
ai) kg/day) day) (EDWC) ([mu]g/ kg/day) kg/day)
liter)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-49 1.5 0.000195 0.024 15 0.00050 0.0247 1,000
------------------------------
Children 1-6 1.5 0.000424 0.021 15 0.0010 0.0224 1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Though residential exposure could occur with the use of 2,4-D,
intermediate-term residential risks were not calculated for any of the
residential scenarios because there are no intermediate term
residential scenarios; residential turf application exposures are
expected to be short-term in duration for broadcast treatments because
the label allows only two broadcast treatments per year and because
2,4-D dissipates rapidly from the turf after application. The turf
transferable residue studies indicated that the 2,4-D half life ranged
from less than 1 day to 2.8 days.
5. Aggregate cancer risk for U.S. population. The aggregate cancer
risk was not calculated for 2,4-D based on the lack of carcinogenicity
in a rat carcinogenicity study and a mouse carcinogenicity study. The
endpoint selected for cPAD is protective of the possible carcinogenic
activity of 2,4-D.
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 2,4-D residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromotography) 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
The Codex Alimentarius Commission has established several maximum
residue limits (MRLs) for residues of 2,4-D in/on various plant and
animal commodities. No Codex MRLs have been established, however, for
the crops
[[Page 43308]]
covered by this tolerance action: Hop, soybean, and wild rice.
C. Conditions
A developmental neurotoxicity study, a subchronic inhalation
toxicity study, a repeat 2-generation reproduction study (using the new
protocol) addressing concerns for endocrine disruption (thyroid and
immunotoxicity measures), grape processing study, wheat hay field
trials, and limited irrigated crop studies (sugar beet roots and tops
and strawberries) are requested.
D. Response to Comments
Public comments were received from B. Sachau who objected to the
proposed tolerances because of the amounts of pesticides already
consumed and carried by the American population. She further indicated
that testing conducted on animals have absolutely no validity and are
cruel to the test animals. B. Sachau's comments contained no scientific
data or evidence to rebut the Agency's conclusion that there is a
reasonable certainty that no harm will result from aggregate exposure
to 2,4-D, including all anticipated dietary exposures and all other
exposures for which there is reliable information. 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 tolerance is established for residues of 2,4-D in or
on hop at 0.05 ppm, soybean at 0.02 ppm, and wild rice at 0.1 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-2005-0038 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 September
26, 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 issue(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\ 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-2005-0038, 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 issue(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
[[Page 43309]]
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
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 20, 2005.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.142 is amended by alphabetically adding commodities to
the table in paragraph (a)(2) introductory text and removing and
reserving paragraph (a)(11) to read as follows:
Sec. 180.142 2,4-D; tolerances for residues.
(a) * * *
(2) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Hop........................................................ 0.05
* * * * *
Rice, wild................................................. 0.1
* * * * *
Soybean.................................................... 0.02
* * * * *
------------------------------------------------------------------------
---------------------------------------------------------------------------
* * * * *
[FR Doc. 05-14886 Filed 7-26-05; 8:45 am]
BILLING CODE 6560-50-S