2,4-D; Pesticide Tolerance, 43298-43309 [05-14886]
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Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations
contrary; and resolution of the factual
issues(s) in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866 due to its lack of
significance, this rule is not subject to
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are
established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
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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
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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 18, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—AMENDED
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.556 is amended by
alphabetically adding the commodity to
the table in paragraph (a) to read as
follows:
I
§ 180.556 Pymetrozine; tolerances for
residues.
(a) * * *
Commodity
Parts per million
Asparagus .......................
*
*
*
*
*
*
*
*
0.04
*
*
[FR Doc. 05–14598 Filed 7–26–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0038; FRL–7726–8]
2,4-D; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of 2,4dichlorophenoxyacetic 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
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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
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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
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available on E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines athttps://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 RhonePoulenc 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 IR4. 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
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43299
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.
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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-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL)
from the toxicity studies reviewed.
TABLE 1.—2,4-D SUBCHRONIC, CHRONIC, AND OTHER TOXICITY
Guideline
No.
Study type
Results
870.3100
90–Day oral toxicity—rodents—rats
NOAEL = 15 milligrams/kilogram/day (mg/kg/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.
870.3150
90–Day oral toxicity—nonrodents—beagle
dogs
NOAEL = 1 mg/kg/day
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.
870.3150
90–Day oral toxicity—nonrodents—beagle
dogs
NOAEL = 1 mg/kg/day
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.
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.
870.3700
Prenatal developmental—rodents—rats
Maternal:
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.
870.3700
Prenatal
rabbits
Maternal:
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.
870.3800
Reproduction and fertility effects—rats
Parental/Systemic:
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.
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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43301
TABLE 1.—2,4-D SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued
Guideline
No.
Study type
Results
870.4300
Combined chronic toxicity carcinogenicity
—rodents (rats)
NOAEL = 5 mg/kg/day
LOAEL = 75 mg/kg/day based on decreased 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
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
870.5265
Gene mutation Ames, reverse mutation
No evidence of bacterial mutation in S. typhimurium strains TA1535, TA1537,
TA1538, TA98, TA100, with and without S9.
870.5395
In vivo erythrocyte micro-nucleus assay
Institute for Cancer Research (ICR)
mice
No significant increase in bone marrow polychromatic erythrocytes.
870.5375
Cytogenetics in vitro chromosome aberration (human lymphocytes)
No evidence of increased chromosome aberrations in human lymphocytes.
870.5385
Cytogenetics in vivo chromosome aberration (Wistar rat bone marrow)
Equivocal (+ at top 2 doses, but results were similar to dimethyl sulfoxide (DMSO)
control).
870.5450
Other effects
(Unscheduled DNA synthesis assay)
No evidence of induction of unscheduled DNA synthesis.
870.6200
Acute neurotoxicity screening battery—
rats
NOAEL = 67 mg/kg/day
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.
870.6200
Subchronic neurotoxicity screening battery—rats
NOAEL = 75 mg/kg/day
LOAEL = 150 mg/kg/day based on increased forelimb grip strength.
870.7485
Metabolism and pharmacokinetics—rats
85.5%–93.7% of dose eliminated in urine; 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.
870.7600
Dermal penetration
5.8%
Special studies pharmacokinetics/ metabolism study (single exposure) Fischer
344 ratand beagle dogs
Study designed specifically to compare the rat and dog with respect to the excretion of 2,4-D and the relevancy of the dog data for risk assessment.
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
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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
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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
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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, interspecies and
intraspecies and any traditional UF
Exposure scenario
Special FQPA SF and
level of concern for risk assessment
Study and toxicological effects
Acute dietary
(Females 13–50 years of age)
NOAEL = 25 mg/kg/day
UF = 1,000
Acute RfD = 0.025 mg/kg/
day
Special FQPA SF = 1
aPAD = acute RfD/Special
FQPA SF = 0.025 mg/
kg/day
Rat developmental toxicity study
LOAEL = 75 mg/kg/day based on skeletal abnormalities.
Acute dietary
(General population including
infants and children)
NOAEL = 67 mg/kg/day
UF = 1,000
Acute RfD = 0.067 mg/kg/
day
Special FQPA SF = 1
aPAD = acute RfD/Special
FQPA SF = 0.067 mg/
kg/day
Acute neurotoxicity study in rats
LOAEL = 227 mg/kg/day based on gait abnormalities.
Chronic dietary
(All populations)
NOAEL = 5 mg/kg/day
UF = 1,000
Chronic RfD =
0.005 mg/kg/day
Special FQPA SF = 1
cPAD = chronic RfD/Special FQPA SF = 0.005
mg/kg/day
Rat chronic toxicity study
LOAEL = 75 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)).
Short-term incidental oral
(1 to 30 days)
(Residential)
Oral study
NOAEL = 25 mg/kg/day
LOC for MOE = 1,000
(Residential)
Rat developmental toxicity study
LOAEL = 75 mg/kg/day based on decreased
maternal body-weight gain.
Intermediate-term incidental
oral
(1 to 6 months)
(Residential)
Oral study
NOAEL = 15 mg/kg/day
LOC for MOE = 1,000
(Residential)
Subchronic oral toxicity—rat
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
(1 to 7 days)
(Residential)
Oral study
NOAEL = 25 mg/kg/day
(Dermal absorption rate = 10
%)
LOC for MOE = 1,000
(Residential)
Rat developmental toxicity study
LOAEL = 75 mg/kg/day based on decreased
maternal body-weight gain and skeletal abnormalities.
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TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR 2,4-D FOR USE IN HUMAN RISK ASSESSMENT—
Continued
Exposure scenario
Dose used in risk assessment, interspecies and
intraspecies and any traditional UF
Special FQPA SF and
level of concern for risk assessment
Study and toxicological effects
Intermediate-term dermal
(1 week to several months)
(Residential)
Oral study
NOAEL = 15 mg/kg/day
(Dermal absorption rate = 10
%
LOC for MOE = 1,000
(Residential)
Subchronic oral toxicity—rat
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.
Long-term dermal
(Several months to lifetime)
(Residential)
Oral study
NOAEL = 5 mg/kg/day
(Dermal absorption rate = 10
% when appropriate)
LOC for MOE = 1,000
(Residential)
Rat chronic toxicity study
LOAEL = 75 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)), increased thyroid weights (both sexes at study
termination), and decreased testes and
ovarian weights.
Short-term inhalation
(1 to 7 days)
(Residential)
Inhalation (or oral) study
NOAEL = 25 mg/kg/day
(Inhalation absorption rate =
100%)
LOC for MOE = 1,000
(Residential)
Rat developmental toxicity study
LOAEL = 75 mg/kg/day based on decreased
maternal body-weight gain and skeletal abnormalities.
Intermediate-term inhalation
(1 week to several months)
(Residential)
Inhalation (or oral) study
NOAEL = 15 mg/kg/day
(Inhalation absorption rate =
100%)
LOC for MOE = 1,000
(Residential)
Subchronic oral toxicity—rat
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.
Long-term inhalation
(Several months to lifetime)
(Residential)
Inhalation (or oral) study
NOAEL = 5 mg/kg/day
(Inhalation absorption rate =
100%)
LOC for MOE = 1,000
(Residential)
Rat chronic toxicity study
LOAEL = 75 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)), increased thyroid weights (both sexes at study
termination), and decreased testes and
ovarian weights.
Cancer
(Oral, dermal, inhalation)
Not likely to pose a cancer risk based on the lack of carcinogenicity in 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
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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.
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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
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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
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TABLE 3.—PERCENT CROP TREATED (PCT) FOR REGISTERED 2,4-D USES—Continued
Crop
Acreage
PCT
Lbs./acre (ai)
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
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combining available Federal, State, and
private market survey data for that use,
averaging by year, averaging across all
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years, and rounding up to the nearest
multiple of five. EPA uses a maximum
PCT for acute dietary risk analysis. The
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maximum PCT figure is the singlemaximum 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 (SCIGROW) 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 highend runoff scenario for pesticides. Both
FIRST and PRZM/EXAMS incorporate
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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 SCIGROW 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 nonoccupational, 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
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toxicity, EPA has not made a common
mechanism of toxicity finding as to 2,4D 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 https://
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 2,4D acid and DEA salt where fetal effects
(skeletal abnormalities) were observed
at a dose level that produced less severe
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maternal toxicity (decreased bodyweight 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 2,4D 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 shortterm 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
Population subgroup
Turf application rate
(lbs. (ae)/ai)
Chronic food exposure
mg/kg/day)
Short-term turf
exposure
(mg/kg/day)
Chronic Estimated Drinking
Water Concentration (EDWC)
(µg/liter)
Drinking water
exposure
(mg/kg/day)
Aggregate exposure
(mg/kg/day)
Aggregate
MOE
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
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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.
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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; email 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
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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
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18:34 Jul 26, 2005
Jkt 205001
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 14th 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
PO 00000
Frm 00050
Fmt 4700
Sfmt 4700
location of the PIRIB described in
ADDRESSES. You may also send an
electronic copy of your request via email 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
E:\FR\FM\27JYR1.SGM
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Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations
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
VerDate jul<14>2003
18:34 Jul 26, 2005
Jkt 205001
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).
Parts per
million
Commodity
*
*
*
*
Soybean ....................................
*
*
*
*
*
*
*
*
*
0.02
*
*
[FR Doc. 05–14886 Filed 7–26–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0171; FRL–7720–3]
Lignosulfonates; Exemptions from the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: The Agency is establishing 44
exemptions from the requirement of a
tolerance for residues of various
lignosulfonate chemicals in or on raw
agricultural commodities when used as
inert ingredients in pesticide
formulations applied to growing crops
or to raw agricultural commodities after
harvest, or to animals under the Federal
List of Subjects in 40 CFR Part 180
Food, Drug, and Cosmetic Act (FFDCA),
as amended by the Food Quality
Environmental protection,
Protection Act of 1996 (FQPA). This
Administrative practice and procedure,
regulation eliminates the need to
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping establish a maximum permissible level
for residues of these lignosulfonate
requirements.
chemicals.
Dated: July 20, 2005.
DATES: This regulation is effective July
Donald R. Stubbs,
27, 2005. Objections and requests for
hearings must be received on or before
Acting Director, Registration Division, Office
of Pesticide Programs.
September 26, 2005.
ADDRESSES: To submit a written
I Therefore, 40 CFR chapter I is
objection or hearing request follow the
amended as follows:
detailed instructions as provided in
PART 180—[AMENDED]
Unit III. of the SUPPLEMENTARY
INFORMATION. EPA has established a
I 1. The authority citation for part 180
docket for this action under docket
continues to read as follows:
identification (ID) number OPP–2005–
Authority: 21 U.S.C. 321(q), 346a and 371.
0171. All documents in the docket are
listed in the EDOCKET index at http:/
I 2. Section 180.142 is amended by
/www.epa.gov/edocket/. Although listed
alphabetically adding commodities to
the table in paragraph (a)(2) introductory in the index, some information is not
publicly available, i.e., Confidential
text and removing and reserving
Business Information (CBI) or other
paragraph (a)(11) to read as follows:
information whose disclosure is
§ 180.142 2,4-D; tolerances for residues.
restricted by statute. Certain other
(a) * * *
material, such as copyrighted material,
(2) * * *
is not placed on the Internet and will be
publicly available only in hard copy
Parts per
form. Publicly available docket
Commodity
million
materials are available either
electronically in EDOCKET or in hard
*
*
*
*
*
Hop ...........................................
0.05 copy at the Public Information and
Records Integrity Branch (PIRIB), Rm.
*
*
*
*
*
Rice, wild ..................................
0.1 119, Crystal Mall #2, 1801 S. Bell St.,
PO 00000
Frm 00051
Fmt 4700
Sfmt 4700
E:\FR\FM\27JYR1.SGM
27JYR1
]]>Agencies
[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Rules and Regulations]
[Pages 43298-43309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14886]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 (https://www.epa.gov/edocket/), you
may access this Federal Register document electronically through the
EPA Internet under the ``Federal Register'' listings at https://
www.epa.gov/fedrgstr/. A frequently updated electronic version of 40
CFR part 180 is available on E-CFR Beta Site Two at https://
www.gpoaccess.gov/ecfr/. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines athttps://
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
----------------------------------------------------------------------------------------------------------------
Guideline No. Study type Results
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
[[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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
870.5395 In vivo erythrocyte micro- No significant increase in bone marrow
nucleus assay Institute polychromatic erythrocytes.
for Cancer Research (ICR)
mice
----------------------------------------------------------------------------------------------------------------
870.5375 Cytogenetics in vitro No evidence of increased chromosome
chromosome aberration aberrations in human lymphocytes.
(human lymphocytes)
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------
870.5450 Other effects No evidence of induction of unscheduled
(Unscheduled DNA synthesis DNA synthesis.
assay).
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
870.6200 Subchronic neurotoxicity NOAEL = 75 mg/kg/day
screening battery--rats LOAEL = 150 mg/kg/day based on increased
forelimb grip strength.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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)).
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
[[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
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