2,4-D; Time-Limited Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: March 8, 2002 (Volume 67, Number 46)]
[Rules and Regulations]
[Page 10622-10631]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr02-10]

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

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301219; FRL-6827-1]
RIN 2070-AB78]

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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

SUMMARY: This regulation extending the time-limited tolerance for
residues of 2,4-D in or on soybeans. Industry Task Force II on 2,4-D
Research Data requested this tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act
(FQPA) of 1996. The tolerance will expire on December 31, 2004.

DATES: This regulation is effective March 8, 2002. Objections and
requests for hearings, identified by docket control number OPP-301219
must be received by EPA on or before May 7, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301219 in the
subject line on the first page of your response.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
Examples of
Categories NAICS Codes Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------

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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action

[[Page 10623]]

to a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents''. You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301219. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Register of October 24, 2001 (66 FR 53791) (FRL-
6803-5), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the
FQPA (Public Law 104-170) announcing the filing of a pesticide petition
(PP) for tolerance by the Industry Task Force II on 2,4-D Research
Data, McKenna and Cuneo, 1900 K Street, NW., Washington, DC 20006-1108.
This notice included a summary of the petition prepared by Industry
Task Force II on 2,4-D Research Data, the registrant. The Agency
received one public comment in response to this notice from the World
Wildlife Fund (WWF) in a letter from K. Thayer et al dated November 21,
2001 (Docket No. PF-1045). The WWF's comment concerned the size of the
FQPA Safety Factor and are further discussed in the Safety Factor for
Infants and Children section below.
The petition requested that 40 CFR 180.142 be amended by extending
the time-limited tolerance for residues of the herbicide 2,4-D, 2,4-
dichlorophenoxyacetic acid, in or on soybeans at 0.02 part per million
(ppm). The tolerance will expire on December 31, 2004.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe''. Section
408(b)(2)(A)(ii) 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)
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 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances November 26, 1997 (62 FR 62961) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), 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), for a tolerance for residues of 2,4-D on soybeans at 0.02
ppm. EPA's assessment of exposures and risks associated with
establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by 2,4-D are discussed
below as well as the no observed adverse effect level (NOAEL) and the
lowest observed adverse effect level (LOAEL) from the toxicity studies
reviewed.
An oral LD₅₀ of 2,4-D acid is 699 milligrams/kilograms
(mg/kg) in the rat. The dermal LD₅₀ in the rabbit is > 2,000
mg/kg. The acute inhalation LC₅₀ in the rat is > 1.8 mg/
liter. A primary eye irritation study in the rabbit showed severe
irritation. A dermal irritation study in the rabbit showed moderate
irritation. A dermal sensitization study in the guinea pig showed no
skin sensitization. An acute neurotoxicity study in the rat produced a
NOAEL of 227 mg/kg for systemic toxicity and a neurobehavioral NOAEL of
67 mg/kg with a LOAEL of 227 mg/kg.
Mutagenicity studies including gene mutation, chromosomal
aberrations, and direct DNA damage tests were negative for mutagenic
effects.
A 2-generation reproduction study was conducted in rats with NOAELs
for parental and developmental toxicity of 5 mg/kg/day. The LOAELs for
this study are established at 20 mg/kg/ day based on reductions in body
weight gain in F₀ and F_2b pups, and reduction in
pup weight at birth and during lactation. A teratology study in rabbits
given gavage doses at 0, 10, 30, and 90 mg/kg on days 6 through 18 of
gestation was negative for developmental toxicity at all doses tested.
A teratology study in rats given gavage doses at 0, 8, 25, and 75 mg/kg
on days 6 through 15 of gestation was negative for developmental
toxicity at all doses tested. A NOAEL for fetotoxicity was established
at 25 mg/kg/day based on delayed ossification at the 75 mg/kg dose
level. The effects on pups occurred in the presence of parental
toxicity.
A subchronic dietary study was conducted with mice fed diets
containing 0, 1, 15, 100, and 300 mg/kg/day with a NOAEL of 15 mg/kg/
day. The LOAEL was established at 100 mg/kg/day based on decreased
glucose and thyroxine levels, increases in absolute and relative kidney
weights, and histopathological lesions in the liver and kidneys. A 90-
day dietary study in

[[Page 10624]]

rats fed diets containing 0, 1, 15, 100, or 300 mg/kg/day resulted in a
NOAEL of 15 mg/kg/day and a LOAEL of 100 mg/kg/day. The LOAEL was based
on decreases in body weight and food consumption, alteration in
clinical pathology, changes in organ weights, and histopathological
lesions in the kidney, liver, and adrenal glands of both sexes of rats.
A 90-day feeding study was conducted in dogs fed diets containing 0,
0.3, 1, 3, and 10 mg/kg/day with a NOAEL of 1 mg/kg/day. The LOAEL was
established at 3 mg/kg/day based on histopathological changes in the
kidneys of male dogs.
A 1-year dietary study was conducted in the dog using doses of 0,
1, 5, and 7.5 mg/kg/day. The NOAEL was 1 mg/kg/day and the LOAEL was 5
mg/kg/day based on clinical chemistry changes and histopathological
lesions in the liver and kidney. A 2-year feeding/carcinogenicity study
was conducted in mice fed diets containing 0, 1, 15, and 45 mg/kg/day
with a NOAEL of 1 mg/kg/day. The systemic LOAEL was established at 15
mg/kg/day based on increased kidney and adrenal weights and homogeneity
of renal tubular epithelium due to cytoplasmic vacuoles. No
carcinogenic effects were observed under the conditions of the study at
any dosage level tested. A second 2-year oncogenicity study was
conducted in mice fed diets containing 0, 5, 62.5, and 125 mg/kg/day
(males) and 0, 5, 150, and 300 mg/kg/day (females). No treatment-
related oncogenicity was observed. A 2-year feeding/carcinogenicity
study was conducted in rats fed diets containing 0, 1, 15, and 45 mg/
kg/day with a NOAEL of 1 mg kg/day. Although there appeared to be a
slight treatment-related incidence of benign brain tumors
(astrocytomas) in male rats fed diets containing 45 mg/kg/day, two
different statistical evaluations found no strong statistical evidence
of carcinogenicity in male rats. There were no carcinogenic effects
observed in female rats. A second 2-year feeding/carcinogenicity study
was conducted in rats fed diets containing 0, 5, 75, and 150 mg/kg/day.
The NOAEL was 5 mg/kg/day and the LOAEL was 75 mg/kg/day based on
decreased body weight, body weight gain, and food consumption; clinical
chemistry changes; organ weight changes and histopathological lesions.
No treatment-related carcinogenic effects or increased incidences of
astrocytomas were observed.
The metabolism of phenyl ring labeled 14C-2,4-D was
studied in the rat following a single intravenous or oral dose of
approximately 1 mg/kg/day. At 48 hours after treatment, recovery of
radioactivity in urine was in excess of 98%. Parent 2,4-D was the major
metabolite (72.9% to 90.5%) found in the urine.

B. Toxicological Endpoints

The dose at which 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, is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the refrence dose (RfD) by such
additional factor. The acute or chronic Population Adjusted Dose (aPAD
or cPAD) is a modification of the RfD to accommodate this type of FQPA
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 is expressed as 1 x
10-6 or one in a million). Under certain specific
circumstances, MOE calculations will be used for the carcinogenic risk
assessment. In this non-linear approach, a ``point of departure'' is
identified below which carcinogenic effects are not expected. The point
of departure is typically a NOAEL based on an endpoint related to
cancer effects though it may be a different value derived from the dose
response curve. To estimate risk, a ratio of the point of departure to
exposure (MOE_cancer = point of departure/exposures) is
calculated. A summary of the toxicological endpoints for 2,4-D used for
human risk assessment is shown in the following Table 1.

Table 1.--Summary of Toxicological Dose and Endpoints for 2,4-D for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk FQPA* SF and Endpoint Study and Toxicological
Exposure Scenario Assessment, UF for Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (females 13-50 years of NOAEL = 25 mg/kg/day FQPA SF = 3 LOAEL = 75 mg/kg/day
age) UF = 100............... aPAD = 0.083 mg/kg/day. based on skeletal
Acute RfD = 0.25 mg/kg/ variations, reduced
day. ossification of the
vertebral arches, and
unossified sternebrae
observed in the
prenatal developmental
study in rats
----------------------------------------------------------------------------------------------------------------
Acute Dietary (general population NOAEL = 67 mg/kg/day FQPA SF = 3 LOAEL = 227 mg/kg/day
including infants and children) UF = 100............... aPAD = 0.22 mg/kg/day.. based on increased
Acute RfD = 0.67 mg/kg/ incidence of
day. incoordination and
slight gait
abnormalities in both
sexes on Day 1 FOB
measurements in the
acute neurotoxicity
study in rats

[[Page 10625]]

----------------------------------------------------------------------------------------------------------------
Chronic Dietary (all Populations) NOAEL = 1 mg/kg/day FQPA SF = 3 LOAEL = 5 mg/kg/day
UF = 100............... cPAD = 0.0033 mg/kg/day based on alterations
Chronic RfD = 0.01 mg/ in serum chemistry
kg/day. with corroborative
histopathological
lesions in the liver
and kidneys in the
chronic dog study
----------------------------------------------------------------------------------------------------------------
Short-Term Incidental Oral (1 day to NOAEL = 25 mg/kg/day FQPA SF = 3 LOAEL = 75 mg/kg/day
1 month) UF = 100............... LOC for MOE = 300...... based on non-
significant decrease
in body weight gain
during the dosing
period (maternal
effects) in the rat
developmental study
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Incidental Oral (1 NOAEL = 1 mg/kg/day FQPA SF = 3 LOAEL = 5 mg/kg/day
month to 6 months) UF = 100............... LOC for MOE = 300...... (see chronic dietary)
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 day to 1 month) NOAEL = 25 mg/kg/day FQPA SF = 3 LOAEL = 75 mg/kg/day
UF = 100............... (residential) (see acute dietary f
Dermal absorption rate LOC for MOE = 300 13-50)
= 5.8%. (residential).
LOC for MOE = 100
(worker).
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 month to NOAEL = 1 mg/kg/day FQPA SF = 3 LOAEL = 5 mg/kg/day
6 months) UF = 100............... (residential) (see chronic dietary)
Dermal absorption rate LOC for MOE = 300
= 5.8%. (residential).
LOC for MOE = 100
(worker).
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate-Term N/A N/A Not required based on
Inhalation LC₅₀ > 1.79 mg/L and
Toxicity Category III
----------------------------------------------------------------------------------------------------------------
Cancer N/A N/A Classified as a Group D
chemical (not
classifiable as to
human carcinogenicity)

----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.142) for the residues of 2,4-D, in or on a
variety of raw agricultural commodities. A time limited tolerance of
0.1 ppm was previously established for residues of 2,4-D on soybeans
resulting from the preplant use of 2,4-D ester or amine 40 CFR
180.142(a)(11). In order for EPA to recommend favorably for the
establishment of permanent tolerances on soybeans, additional field
trial data and processing data were required. In response, the Industry
Task Force II on 2,4-D Research Data (Task Force II) submitted field
residue data on soybeans. EPA has reviewed these data and concluded
that a temporary tolerance of 0.02 ppm is appropriate for soybean. Task
Force II has thus proposed to extend the soybean tolerance to December
31, 2004 at a level of 0.02 ppm. Risk assessments were conducted by EPA
to assess dietary exposures from 2,4-D in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. The Dietary Exposure Evaluation Model
(DEEM) analysis evaluated the individual food consumption as
reported by respondents in the USDA 1989-1992 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments: The acute exposure analysis for all
subgroups was performed using tolerance-level residues (with the
exception of anticipated residues on citrus) and 100 percent crop
treated. Using these assumptions, acute dietary exposure from food to
2,4-D will occupy 7.3% of the acute population adjusted dose (aPAD) for
the U.S. population, 12% of the aPAD for females 13 years and older,
9.4% of the aPAD for infants less than 1 year old, 12% of the aPAD for
children 1 - 6 years old, and 8.8% of the aPAD for children 7 - 12
years old.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: The chronic
exposure analysis for all subgroups was performed using anticipated
residues on the most highly consumed food items (and tolerance-level
residues on the remaining food items) and percent crop treated data for
various crops. Using these assumptions, chronic dietary exposure to
2,4-D from food will utilize 24% of the chronic popolation adjusted
dose (cPAD) for the U.S. population, 20% for females 13 years and
older, 19% of the cPAD for infants less than 1 year old, 46% of the
cPAD for children 1 - 6 years old, and 36% of the cPAD for children 7 -
12 years old.
Section 408(b)(2)(E) 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 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

[[Page 10626]]

require similar data on a time frame it deems appropriate. As required
by section 408(b)(2)(E), EPA will issue a data call-in for information
relating to anticipated residues to be submitted no later than 5 years
from the date of issuance of this tolerance.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of percent crop
treated (PCT) as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used percent crop treated (PCT) information as follows.

------------------------------------------------------------------------
Percent
Crop crop
treated
------------------------------------------------------------------------
Asparagus.................................................. 13
Barley..................................................... 37
Corn (pop)................................................. 15
Corn (sweet)............................................... 9
Barley..................................................... 37
Grapefruit................................................. 2
Lemons..................................................... 1
Oats....................................................... 15
Oranges.................................................... 4
Rice....................................................... 14
Rye........................................................ 1
Sorghum.................................................... 13
Sugarcane.................................................. 35
Tangerines................................................. 4
Wheat...................................................... 34
Wheat germ oil............................................. 55
------------------------------------------------------------------------

The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. 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, 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. Information is available
from the U.S. Geological Survey (USGS) National Water Quality
Assessment (NAWQA) program concerning residues of 2,4-D in water.
Regarding groundwater, USGS-NAWQA monitoring data indicate a maximum
2,4-D concentration in groundwater of 14.8 ppb. Therefore, the exposure
value of 14.8 ppb will be used in both the chronic aggregate risk and
acute aggregate risk assessments for groundwater. Regarding surface
water, an assessment of USGS-NAWQA monitoring data indicate a maximum
ambient 2,4-D concentration of 15.0 ppb in rivers and streams.
Therefore, the exposure value of 15 ppb will be used for chronic
aggregate risk assessment for surface water. For acute aggregate risk
assessment for surface water, however, calculations indicate that
direct water application of 2,4-D will yield the highest water
concentrations for all labeled 2,4-D use patterns. The value for the
water concentrations calculated from direct water application of 2,4-D
is 1,561 ppb; therefore, the exposure value of 1,561 ppb will be used
in acute aggregate risk assessment for surface water.
Drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to 2,4-D, they are further
discussed in the aggregate risk sections below.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
2,4-D is currently registered for use on the following residential
non-dietary sites: ornamental turf, lawns, and grasses, golf course
turf, recreational areas, and several other indoor and outdoor uses.
The risk assessment was conducted using the following residential
exposure assumptions: There are chemical-specific and site-specific
data available to determine the potential risks associated with
residential exposures from the registered uses of 2,4-D. Dislodgeable
residues of 2,4-D taken during exposure sessions showed a rapid decline
from 1 hour following application (8%) to 24 hours following
applications (1%). No detectable residues were found in urine samples
supplied by volunteers exposed to sprayed turf 24 hours following
application. Intermediate-term postapplication exposure is thus not
expected. The following assessments are based on the available chemical
specific data.
i. Chronic exposure and risk. Although a chronic endpoint was
chosen, this risk assessment was not conducted because there is no
chronic exposure scenario for this use.
ii. Short- and intermediate-term exposure and risk. For short-term
dermal margin of exposure (MOE) calculations, EPA used the maternal
NOAEL of 30 mg/kg/day from the oral developmental toxicity study in
rabbits. The LOAEL of 90 mg/kg/day was based on abortions, clinical
signs (ataxia, decreased motor activity, and cold extremities during
gestation), and decreased body weight gain. For acute toxicity, EPA
reduced the FQPA factor of 10 to 3 for females 13+ and removed the FQPA
factor for all other population subgroups. As the short-term and acute
endpoints are based on the oral developmental toxicity study, this
decision is also applicable to the short-

[[Page 10627]]

term, nonoccupational assessment. Therefore, based on this
recommendation, the MOE needed for females 13+ is 300. Since there are
no intermediate residential exposures, intermediate risk assessment is
not required.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether 2,4-D has a common mechanism of toxicity with other substances
or how to include this pesticide in a cumulative risk assessment.
Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, 2,4-D does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has not assumed that
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 final rule for Bifenthrin Pesticide Tolerances
(62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

1. Safety factor for infants and children--i. In general. FFDCA
section 408 provides that EPA shall apply an additional tenfold margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
data base on toxicity and exposure unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a MOE analysis or through using uncertainty
(safety) factors in calculating a dose level that poses no appreciable
risk to humans.
ii. Prenatal and postnatal sensitivity. The toxicological data base
for evaluating prenatal and postnatal toxicity for 2,4-D is complete
with respect to current data requirements. There are no prenatal
toxicity concerns for infants and children based on the lack of
evidence of quantitative or qualitative increased susceptibility in the
prenatal developmental toxicity studies in rats and rabbits or in the
2-generation reproduction study in rats.
The WWF commented that the 10x FQPA Safety Factor should be
retained based on two rationales: (1) Evidence of quantitative
susceptibility in the developmental rat study and (2) evidence of
qualitative susceptibility because it is a thyroid endocrine disruptor.
Therefore, the Agency has reevaluated the results of the developmental
toxicity study in rats to assess the potential for increased
susceptibility to infants and children following exposure to 2,4-D.
Regarding evidence of quantitative susceptibility in the
developmental toxicity study in rats, the initial review of this study
concluded that for maternal toxicity, the NOAEL was 25 mg/kg/day and
the LOAEL was 75 mg/kg/day based on decreases in body weight gain in
the maternal animals during the dosing period (gestation days 6 through
15). When compared to the vehicle control group, maternal body weight
gain decreases were: -43% during gestation days 6 through 10 and -21%
during days 6 through 15 at the 75 mg/kg/day group. Although these
decreases were not statistically significant, they are biologically
significant and attributed to treatment because decreases in body
weight gain were also seen in the 2-generation reproduction study in
the same strain of rats at a comparable dietary dose level (75 mg/kg/
day). Additionally, the fact that the maternal animals regained their
body weight following cessation of exposure (dosing) indicated that the
decreases were indeed due to treatment with 2,4-D. EPA reconfirmed that
maternal toxicity was seen at 75 mg/kg/day, the LOAEL.
With regard to the developmental toxicity, fetal effects are
manifested as skeletal variations (not malformations) at the same dose
that caused maternal toxicity. The skeletal variations included:
presence of 7th cervical rib; presence of 14th rudimentary rib; mal-
aligned sternebrae; reduced ossification of the vertebral arches and
unossified sternebrae. These effects were not considered to be severe
in nature because: (1) The presence of ribs indicate extra
ossification; (2) malaligned sternebrae, reduced ossification of the
vertebral arches and unossified sternebrae which are delays in
ossification, were also seen in the controls; (3) there was no dose-
response relationship for any of the variations; (4) the incidences
were not statistically significant when compared to the vehicle
control; (5) no increases were seen when litter incidences were
considered; (6) fetal variations were seen in the presence of maternal
toxicity; and (7) no malformations were seen at any dose level.
Based on these results, EPA reconfirmed that there is no evidence
for increased susceptibility since the mild fetal effects were seen in
the presence of maternal toxicity. This conclusion is supported by the
lack of evidence for either quantitative or qualitative susceptibility
in the developmental toxicity study in rabbits or in the 2-generation
reproduction study. In rabbits, no developmental toxicity was seen at
the highest dose tested. In the two-generation reproduction study,
offspring toxicity (decreased pup body weight during lactation in
F_1b pups) was seen in the presence of parental/systemic
toxicity (degeneration of male kidney tubule and decreased weight gain
in females) at the same dose. In addition, no evidence of
susceptibility was seen in the developmental toxicity studies conducted
with the salts and esters of 2,4-D; in these studies, the developmental
toxicity occurred either at the same dose levels or higher dose levels
that caused maternal toxicity.
Regarding evidence of qualitative susceptibility as potential
thyroid endocrine disruptor, the thyroid effects seen in the subchronic
(decreases in T4, follicular cell hypertrophy) and chronic (decreases
in T4, increase in thryoid weights) toxicity study in rats occurred
only at high doses. These effects were seen in the presence of other
systemic (liver or kidney) toxicity, and there was no evidence of
thyroid toxicity in dogs. No evidence of endocrine disruptions were
seen in the appropriate parameters that evaluated this effect in the
two-generation reproduction study.
EPA is currently developing policy, procedures and data
requirements for endocrine disruptors. If, as a part of the review
under reregistration, 2,4-D is identified as a potential endocrine
disruptor, 2,4-D will be assessed according to EPA policy and
appropriate data will be requested.
iii. Conclusion. There is a complete toxicity data base for 2,4-D
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. An FQPA safety factor is
necessary for 2,4-D since there is evidence of neuropathology (retinal
degeneration) in female rats at the 1-year measurements made in the
chronic neurotoxicity study in rats. This finding triggers the need for
a developmental neurotoxicity study and an FQPA safety factor for this
data gap. However, the safety factor can be reduced to 3x based on the
fact that the

[[Page 10628]]

toxicology data base is complete for the core studies required for FQPA
assessment, that there is no evidence of quantitative or qualitative
increased susceptibility in the prenatal developmental toxicity studies
in rats and rabbits or in the 2-generation reproduction study in rats,
and that the exposure assessments will not underestimate the potential
dietary (food and water) and non-dietary exposure resulting from the
use of 2,4-D.
Since there is a concern for neuropathology which triggers a
developmental neurotoxicity study, the FQPA safety factor is applicable
to all population subgroups for acute and chronic dietary assessments
and to residential exposure and risk assessment of all durations. The
result of the developmental neurotoxicity study could inform all
endpoint selections.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the
calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes
with reasonable certainty that exposures to the pesticide in drinking
water (when considered along with other sources of exposure for which
OPP has reliable data) would not result in unacceptable levels of
aggregate human health risk at this time. Because OPP considers the
aggregate risk resulting from multiple exposure pathways associated
with a pesticide's uses, levels of comparison in drinking water may
vary as those uses change. If new uses are added in the future, OPP
will reassess the potential impacts of residues of the pesticide in
drinking water as a part of the aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to 2,4-D
will occupy 7.3% of the aPAD for the U.S. population, 12% of the aPAD
for females 13 years and older, 9.4% of the aPAD for infants less than
1 year old and 8.8% of the aPAD for children 7 - 12 years old. In
addition, there is potential for acute dietary exposure to 2,4-D in
drinking water. After calculating DWLOCs and comparing them to the EECs
for surface and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the aPAD, as shown in the following Table 2:

Table 2.--Aggregate Risk Assessment for Acute Exposure to 2,4-D
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................ 0.22 7.3 1,561 14.8 7,100
All Infants (< 1 year) old..................... 0.22 9.4 1,561 14.8 2,000
Children 1-6 yrs old........................... 0.22 12 1,561 14.8 1,900
Children 7-12 yrs old.......................... 0.22 8.8 1,561 14.8 2,000
Females 13-50 yrs old.......................... 0.083 12 1,561 14.8 2,200
----------------------------------------------------------------------------------------------------------------

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 will utilize 24% of the cPAD for the U.S. population, 19% of
the cPAD for infants less than 1 year old and 46% of the cPAD for
children 1 - 6 years old. Based on the use pattern, chronic residential
exposure to residues of 2,4-D is not expected. In addition, there is
potential for chronic dietary exposure to 2,4-D in drinking water.
After calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 3:

Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to 2,4-D
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................ 0.0033 24 15 14.8 88
All Infants (< 1 year) old..................... 0.0033 19 15 14.8 27
Children 1-6 yrs old........................... 0.0033 46 15 14.8 18
Children 7-12 yrs old.......................... 0.0033 36 15 14.8 21
Females 13-50 yrs old.......................... 0.0033 20 15 14.8 80
----------------------------------------------------------------------------------------------------------------

[[Page 10629]]

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
and the Agency has determined that it is appropriate to aggregate
chronic food and water and short-term exposures for 2,4-D. Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded that food and residential exposures aggregated result
in aggregate MOEs of 853 for the U.S. population, 943 for infants less
than 1 year old, 912 for children 1 - 6 years old, and 859 for females
13 years and older. These aggregate MOEs do not exceed the Agency's
level of concern for aggregate exposure to food and residential uses.
In addition, short-term DWLOCs were calculated and compared to the EECs
for chronic exposure of 2,4-D in ground and surface water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in the following Table
4:

Table 4.--Aggregate Risk Assessment for Short-Term Exposure to 2,4-D
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup Aggregate MOE (Food + Aggregate Level of Water EEC Water EEC Short-Term
Residential) Concern (LOC) (ppb) (ppb) DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
US Population.................................................. 853 300 15 14.8 1,890
All Infants (< 1 year) old..................................... 943 300 15 14.8 568
Children 1-6 yrs old........................................... 912 300 15 14.8 559
Females 13-50 yrs old.......................................... 859 300 15 14.8 1,630
--------------------------------------------------------------------------------------------------------------------------------------------------------

4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to 2,4-D residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology is available (gas chromatography
(GC) with electron capture detection (ECD), EN-CAS Method ENC-2/93.
This GC/ECD method has undergone successful independent laboratory
validation and is available to enforce the time-limited tolerance on
soybean seed.

B. International Residue Limits

There are no Codex, Canadian or Mexican residue limits established
for 2,4-D on soybeans.

C. Conditions

This tolerance with an expiration date was required by EPA to allow
the Industry Task Force II on 2,4-D Research Data to submit additional
field residue trials, including bridging studies with ester and amine
formulations, plant metabolism studies, storage stability data, and
oncogenicity studies in two species, rat and mouse preferred. Because
the Agency has not completed the regulatory assessment of its
scientific findings, EPA is proposing to amend 40 CFR 180.142 to extend
the expiration date for these tolerances until December 31, 2004.

V. Conclusion

Therefore, the tolerance is established for residues of 2,4-D, 2,4-
dichlorophenoxyacetic acid, in or on soybeans at 0.02 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409.
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 control number OPP-301219 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 May 7,
2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of

[[Page 10630]]

the Administrator such a waiver or refund is equitable and not contrary
to the purpose of this subsection.'' For additional information
regarding the waiver of these fees, you may contact James Tompkins by
phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by
mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301219, 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.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

This final rule establishes a tolerance under FFDCA section 408(d)
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,
entitled 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4).
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. Submission to Congress and the Comptroller General

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

[[Page 10631]]

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: February 26, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

2. Section 180.142 is amended by revising paragraph (a)(11) to read
as follows:

Sec. 180.142 2,4-D, tolerances for residues.

(a) * * *
(11) A tolerance that expires on December 31, 2004 is established
for residues of the herbicide 2,4-D (2,4-dichlorophenoxyacetic acid)
resulting from the preplant use of 2,4-D ester or amine in or on the
raw agricultural commodity as follows:

------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Soybean, seed..................... 0.02 12/31/04
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-5606 Filed 3-7-02; 8:45 am]
BILLING CODE 6560-50-S

2,4-D; Time-Limited Pesticide Tolerance

Local Navigation