[Federal Register Volume 67, Number 46 (Friday, March 8, 2002)]
[Rules and Regulations]
[Pages 10622-10631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5606]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301219; FRL-6827-1]
RIN 2070-AB78]


2,4-D; Time-Limited Pesticide Tolerance

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: [email protected].

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 F2b 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 (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 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 
F1b 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 [email protected], or by 
mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    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: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. 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