[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Rules and Regulations]
[Pages 43298-43309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14886]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0038; FRL-7726-8]


2,4-D; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 2,4-
dichlorophenoxyacetic acid (2,4-D) in or on hop, soybean, and wild rice 
. Interregional Research Project Number 4 (IR-4) and the Industry Task 
Force II on 2,4-D Research Data (Task Force) and its registrant members 
and affiliates on behalf of IR-4 requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective July 27, 2005. Objections and 
requests for

[[Page 43299]]

hearings must be received on or before September 26, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2005-0038. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket/. 
Although listed in the index, some information is not publicly 
available, i.e., Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either electronically in 
EDOCKET or in hard copy at the Public Information and Records Integrity 
Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. Bell St., 
Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
ProtectionAgency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

     In addition to using EDOCKET (http://www.epa.gov/edocket/), you 
may access this Federal Register document electronically through the 
EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 
CFR part 180 is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. To access the OPPTS Harmonized Guidelines 
referenced in this document, go directly to the guidelines athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of March 14, 2002 (67 FR 11480) (FRL-6826-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
6E4636) by Interregional Research Project Number 4 (IR-4), 681 U.S. 
Highway 1 South, North Brunswick, NJ 08902-3390. The petition 
requested that 40 CFR 180.142 be amended by establishing a tolerance 
for residues of the herbicide 2,4-D in or on wild rice at 0.1 parts per 
million (ppm). That notice included a summary of the petition prepared 
by Rhone-Poulenc Ag Co., the registrant. In the Federal Register of 
December 15, 2004 (69 FR 75066) (FRL-7688-2), EPA issued a notice 
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of a pesticide petition (PP 4E3060) by the Task 
Force and its registrant members and affiliates, 1900 K St., NW., 
Washington, DC 20006 on behalf of IR-4. The petition requested that 40 
CFR 180.142(a)(11) be amended by removing the expiration date of 
December 31, 2004 for 2,4-D in or on the raw agricultural commodity 
soybean seed at 0.02 ppm. That notice included a summary of the 
petition prepared by the Task Force, the petitioner. In the Federal 
Register of April 13, 2005 (70 FR 19442) (FRL-7707-9), EPA issued a 
notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of a pesticide petition (PP 2E6352) by IR-4, 681 
U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The 
petition requested that 40 CFR part 180 be amended by establishing a 
tolerance for residues of the herbicide 2,4-D in or on hop at 0.05 ppm. 
That notice included a summary of the petition prepared by IR-4, the 
petitioner. Two comments were received in response to the notices of 
filing and they are addressed in Unit IV.D.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of 2,4-D on hop at 
0.05 ppm, soybean at 0.02 ppm, and wild rice at 0.1 ppm. EPA's 
assessment of exposures and risks associated with establishing the 
tolerance follows.

[[Page 43300]]

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the toxic effects caused by 2,4-D are discussed in Table 1 of this 
unit as well as the no-observed-adverse-effect-level (NOAEL) and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
reviewed.

                             Table 1.--2,4-D Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                        Study type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity--       NOAEL = 15 milligrams/kilogram/day (mg/kg/
                                          rodents--rats                day)
                                                                      LOAEL = 100 mg/kg/day based on decreases
                                                                       in body weight/gain, alterations in
                                                                       hematology and clinical chemistry
                                                                       (decreased T3 and T4) parameters, and
                                                                       cataract formation in females.
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity--       NOAEL = 1 mg/kg/day
                                          nonrodents--beagle dogs     LOAEL = 3 mg/kg/day based on decreased
                                                                       body weight/body-weight gain and food
                                                                       consumption (males), alterations in
                                                                       clinical chemistry parameters (increased
                                                                       blood urea nitrogen (BUN) (both sexes),
                                                                       creatinine (males)), and decreased testis
                                                                       weight in males.
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity--       NOAEL = 1 mg/kg/day
                                          nonrodents--beagle dogs     LOAEL = 3.75 mg/kg/day based on decreased
                                                                       body-weight gain (both sexes) and food
                                                                       consumption (males), as well as
                                                                       alterations in clinical chemistry
                                                                       parameters (increased BUN, creatinine,
                                                                       and alanine aminotransferase) in both
                                                                       sexes, and decreased testes weight and
                                                                       slightly higher incidence of
                                                                       hypospermatogenesis/juvenile testis and
                                                                       inactive/juvenile prostate were observed.
----------------------------------------------------------------------------------------------------------------
870.3200                                 21-Day dermal toxicity       NOAEL = 1,000 mg/kg/day
                                                                      LOAEL = >1,000 mg/kg/day based on no
                                                                       adverse effects at the limit dose.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental--     Maternal:
                                          rodents--rats               NOAEL = 25 mg/kg/day
                                                                      LOAEL = 75 mg/kg/day based on decreased
                                                                       body-weight gains. Survival was not
                                                                       affected by treatment.
                                                                      Developmental:
                                                                      NOAEL = 25 mg/kg/day
                                                                      LOAEL = 75 mg/kg/day based on skeletal
                                                                       abnormalities.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental--     Maternal:
                                          nonrodents--rabbits         NOAEL = 30 mg/kg/day
                                                                      LOAEL = 90 mg/kg/day based on clinical
                                                                       signs (ataxia, decreased motor activity,
                                                                       loss of righting reflex, cold
                                                                       extremities), abortion (2), decreased
                                                                       body-weight gains. Survival was not
                                                                       affected by treatment.
                                                                      Developmental:
                                                                      NOAEL = 30 mg/kg/day
                                                                      LOAEL = 90 mg/kg/day based on abortions.
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility   Parental/Systemic:
                                          effects--rats               NOAEL = 5 mg/kg/day
                                                                      LOAEL = 20 mg/kg/day based on decreased
                                                                       female body weight/body-weight gain (F1)
                                                                       and renal tubule alteration in males (F0
                                                                       and F1).
                                                                      Reproductive:
                                                                      NOAEL = 20 mg/kg/day
                                                                      LOAEL = 80 mg/kg/day based on an increase
                                                                       in gestation length (F0 females producing
                                                                       F1b pups).
                                                                      Offspring:
                                                                      NOAEL = 5 mg/kg/day
                                                                      LOAEL = 20 mg/kg/day based on decreased
                                                                       pup body weight (F1b). At 80 mg/kg/day,
                                                                       there was an increase in dead pups.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity--dogs       NOAEL = 1 mg/kg/day
                                                                      LOAEL = 5 mg/kg/day based on decreased
                                                                       body-weight gain (both sexes) and food
                                                                       consumption (females), as well as
                                                                       alterations in clinical chemistry
                                                                       parameters (increased BUN, creatinine,
                                                                       and alanine aminotransferase, decreased
                                                                       glucose) in both sexes, and decreased
                                                                       brain weight in females, and
                                                                       histopathological lesions in liver and
                                                                       kidneys.
----------------------------------------------------------------------------------------------------------------

[[Page 43301]]

 
870.4300                                 Combined chronic toxicity    NOAEL = 5 mg/kg/day
                                          carcinogenicity --rodents   LOAEL = 75 mg/kg/day based on decreased
                                          (rats)                       body-weight gain (females) and food
                                                                       consumption (females), alterations in
                                                                       hematology (decreased red blood cells
                                                                       (RBC), hematocrit (HCT), and hemoglobin
                                                                       (HGB) (females), platelets (both sexes))
                                                                       and clinical chemistry parameters
                                                                       (increased creatinine (both sexes),
                                                                       alanine and aspartate aminotransferases
                                                                       (males), alkaline phosphatase (both
                                                                       sexes), decreased T4 (both sexes),
                                                                       glucose (females), cholesterol (both
                                                                       sexes), and triglycerides (females)),
                                                                       increased thyroid weights (both sexes at
                                                                       study termination), and decreased testes
                                                                       and ovarian weights. At highest dose
                                                                       tested (HDT), there were microscopic
                                                                       lesions in the eyes, liver, adipose
                                                                       tissue, and lungs.
                                                                      There was no evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity--mice        NOAEL = 5 mg/kg/day
                                                                      LOAEL = 62/150 mg/kg/day based on an
                                                                       increased absolute and/or relative kidney
                                                                       weights and an increased incidence of
                                                                       renal microscopic lesions.
                                                                      There was no evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5265                                 Gene mutation Ames, reverse  No evidence of bacterial mutation in S.
                                          mutation                     typhimurium strains TA1535, TA1537,
                                                                       TA1538, TA98, TA100, with and without S9.
----------------------------------------------------------------------------------------------------------------
870.5395                                 In vivo erythrocyte micro-   No significant increase in bone marrow
                                          nucleus assay Institute      polychromatic erythrocytes.
                                          for Cancer Research (ICR)
                                          mice
----------------------------------------------------------------------------------------------------------------
870.5375                                 Cytogenetics in vitro        No evidence of increased chromosome
                                          chromosome aberration        aberrations in human lymphocytes.
                                          (human lymphocytes)
----------------------------------------------------------------------------------------------------------------
870.5385                                 Cytogenetics in vivo         Equivocal (+ at top 2 doses, but results
                                          chromosome aberration        were similar to dimethyl sulfoxide (DMSO)
                                          (Wistar rat bone marrow)     control).
----------------------------------------------------------------------------------------------------------------
870.5450                                 Other effects                No evidence of induction of unscheduled
                                         (Unscheduled DNA synthesis    DNA synthesis.
                                          assay).
----------------------------------------------------------------------------------------------------------------
870.6200                                 Acute neurotoxicity          NOAEL = 67 mg/kg/day
                                          screening battery--rats     LOAEL = 227 mg/kg/day based on an
                                                                       increased incidence of incoordination and
                                                                       slight gait abnormalities (described as
                                                                       forepaw flexing or knuckling) and
                                                                       decreased total motor activity.
----------------------------------------------------------------------------------------------------------------
870.6200                                 Subchronic neurotoxicity     NOAEL = 75 mg/kg/day
                                          screening battery--rats     LOAEL = 150 mg/kg/day based on increased
                                                                       forelimb grip strength.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and               85.5%-93.7% of dose eliminated in urine;
                                          pharmacokinetics--rats       3.6%-10.5% of dose eliminated via the
                                                                       feces; no differences noted between the
                                                                       sexes; at the high-dose level, it appears
                                                                       that a nonlinear region (decreased
                                                                       clearance) is being reached in the
                                                                       disposition of 2,4-D.
                                                                      Parent 2,4-D was the major metabolite
                                                                       found in urine (72.9%-90.5% of the oral
                                                                       dose), with small amounts of
                                                                       uncharacterized compounds (0.6%-1.3% and
                                                                       0%-0.7%) being found in the urine.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal penetration           5.8%
----------------------------------------------------------------------------------------------------------------
                                         Special studies              Study designed specifically to compare the
                                          pharmacokinetics/            rat and dog with respect to the excretion
                                          metabolism study (single     of 2,4-D and the relevancy of the dog
                                          exposure) Fischer 344        data for risk assessment.
                                          ratand beagle dogs
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    Three other types of safety or UFs may be used:``Traditional 
uncertainty factors;'' the ``special FQPA safety factor;'' and the 
``default FQPA safety factor.'' By the term ``traditional uncertainty 
factor,'' EPA is referring to those additional UFs used prior to FQPA 
passage to account for database deficiencies. These traditional 
uncertainty factors have been incorporated by FQPA into the additional 
safety factor for the protection of infants and children. The term 
``special FQPA safety factor'' refers to those safety factors that are 
deemed necessary for the protection of infants

[[Page 43302]]

and children primarily as a result of FQPA. The ``default FQPA safety 
factor'' is the additional 10X safety factor that is mandated by the 
statute unless it is decided that there are reliable data to choose a 
different additional factor (potentially a traditional uncertainty 
factor or a special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, this additional factor is applied to the RfD by dividing the RfD 
by such additional factor. The acute or chronic Population Adjusted 
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this 
type of safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-\5\), one in a million (1 X 10-\6\), or one in 
ten million (1 X 10-\7\). Under certain specific 
circumstances, MOE calculations will be used for the carcinogenic risk 
assessment. In this non-linear approach, a ``point of departure'' is 
identified below which carcinogenic effects are not expected. The point 
of departure is typically a NOAEL based on an endpoint related to 
cancer effects though it may be a different value derived from the dose 
response curve. To estimate risk, a ratio of the point of departure to 
exposure (MOEcancer = point of departure/exposures) is 
calculated.
    A summary of the toxicological endpoints for 2,4-D used for human 
risk assessment is shown in Table 2 of this unit:

        Table 2.--Summary of Toxicological Dose and Endpoints for 2,4-D for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose used in risk
                                             assessment,          Special FQPA SF and
          Exposure scenario                interspecies and       level of concern for   Study and toxicological
                                         intraspecies and any       risk assessment              effects
                                            traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 25 mg/kg/day     Special FQPA SF = 1      Rat developmental
(Females 13-50 years of age).........   UF = 1,000............  aPAD = acute RfD/         toxicity study
                                       Acute RfD = 0.025 mg/kg/  Special FQPA SF =       LOAEL = 75 mg/kg/day
                                        day.                     0.025 mg/kg/day.         based on skeletal
                                                                                          abnormalities.
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 67 mg/kg/day     Special FQPA SF = 1      Acute neurotoxicity
(General population including infants   UF = 1,000............  aPAD = acute RfD/         study in rats
 and children).                        Acute RfD = 0.067 mg/kg/  Special FQPA SF =       LOAEL = 227 mg/kg/day
                                        day.                     0.067 mg/kg/day.         based on gait
                                                                                          abnormalities.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL = 5 mg/kg/day      Special FQPA SF = 1      Rat chronic toxicity
(All populations)....................   UF = 1,000............  cPAD = chronic RfD/       study
                                       Chronic RfD =..........   Special FQPA SF =       LOAEL = 75 mg/kg/day
                                       0.005 mg/kg/day........   0.005 mg/kg/day.         based on decreased
                                                                                          body-weight gain
                                                                                          (females) and food
                                                                                          consumption (females),
                                                                                          alterations in
                                                                                          hematology (decreased
                                                                                          RBC, HCT, and HGB
                                                                                          (females), platelets
                                                                                          (both sexes)) and
                                                                                          clinical chemistry
                                                                                          parameters (increased
                                                                                          creatinine (both
                                                                                          sexes), alanine and
                                                                                          aspartate
                                                                                          aminotransferases
                                                                                          (males), alkaline
                                                                                          phosphatase (both
                                                                                          sexes), decreased T4
                                                                                          (both sexes), glucose
                                                                                          (females), cholesterol
                                                                                          (both sexes), and
                                                                                          triglycerides
                                                                                          (females)).
----------------------------------------------------------------------------------------------------------------
Short-term incidental oral             Oral study               LOC for MOE = 1,000      Rat developmental
(1 to 30 days).......................   NOAEL = 25 mg/kg/day..  (Residential)..........   toxicity study
(Residential)........................                                                    LOAEL = 75 mg/kg/day
                                                                                          based on decreased
                                                                                          maternal body-weight
                                                                                          gain.
----------------------------------------------------------------------------------------------------------------
Intermediate-term incidental oral      Oral study               LOC for MOE = 1,000      Subchronic oral
(1 to 6 months)......................   NOAEL = 15 mg/kg/day..  (Residential)..........   toxicity--rat
(Residential)........................                                                    LOAEL = 100 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight/body-
                                                                                          weight gain,
                                                                                          alterations in some
                                                                                          hematology (decreased
                                                                                          platelets (both
                                                                                          sexes)) and clinical
                                                                                          chemistry (decreased
                                                                                          T3 (females) and T4
                                                                                          (both sexes))
                                                                                          parameters, and
                                                                                          cataract formation.
----------------------------------------------------------------------------------------------------------------
Short-term dermal                      Oral study               LOC for MOE = 1,000      Rat developmental
(1 to 7 days)........................   NOAEL = 25 mg/kg/day..   (Residential).........   toxicity study
(Residential)........................  (Dermal absorption rate                           LOAEL = 75 mg/kg/day
                                        = 10 %).                                          based on decreased
                                                                                          maternal body-weight
                                                                                          gain and skeletal
                                                                                          abnormalities.
----------------------------------------------------------------------------------------------------------------

[[Page 43303]]

 
Intermediate-term dermal               Oral study               LOC for MOE = 1,000      Subchronic oral
(1 week to several months)...........  NOAEL = 15 mg/kg/day...  (Residential)..........   toxicity--rat
(Residential)........................  (Dermal absorption rate                           LOAEL = 100 mg/kg/day
                                        = 10 %.                                           based on decreased
                                                                                          body weight/body-
                                                                                          weight gain,
                                                                                          alterations in some
                                                                                          hematology (decreased
                                                                                          platelets (both
                                                                                          sexes)) and clinical
                                                                                          chemistry (decreased
                                                                                          T3 (females) and T4
                                                                                          (both sexes))
                                                                                          parameters, and
                                                                                          cataract formation.
----------------------------------------------------------------------------------------------------------------
Long-term dermal                       Oral study               LOC for MOE = 1,000      Rat chronic toxicity
(Several months to lifetime).........   NOAEL = 5 mg/kg/day...  (Residential)..........   study
(Residential)........................  (Dermal absorption rate                           LOAEL = 75 mg/kg/day
                                        = 10 % when                                       based on decreased
                                        appropriate).                                     body-weight gain
                                                                                          (females) and food
                                                                                          consumption (females),
                                                                                          alterations in
                                                                                          hematology (decreased
                                                                                          RBC, HCT, and HGB
                                                                                          (females), platelets
                                                                                          (both sexes)) and
                                                                                          clinical chemistry
                                                                                          parameters (increased
                                                                                          creatinine (both
                                                                                          sexes), alanine and
                                                                                          aspartate
                                                                                          aminotransferases
                                                                                          (males), alkaline
                                                                                          phosphatase (both
                                                                                          sexes), decreased T4
                                                                                          (both sexes), glucose
                                                                                          (females), cholesterol
                                                                                          (both sexes), and
                                                                                          triglycerides
                                                                                          (females)), increased
                                                                                          thyroid weights (both
                                                                                          sexes at study
                                                                                          termination), and
                                                                                          decreased testes and
                                                                                          ovarian weights.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation                  Inhalation (or oral)     LOC for MOE = 1,000      Rat developmental
(1 to 7 days)........................   study                   (Residential)..........   toxicity study
(Residential)........................   NOAEL = 25 mg/kg/day..                           LOAEL = 75 mg/kg/day
                                       (Inhalation absorption                             based on decreased
                                        rate = 100%).                                     maternal body-weight
                                                                                          gain and skeletal
                                                                                          abnormalities.
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation           Inhalation (or oral)     LOC for MOE = 1,000      Subchronic oral
(1 week to several months)...........   study                   (Residential)..........   toxicity--rat
(Residential)........................   NOAEL = 15 mg/kg/day..                           LOAEL = 100 mg/kg/day
                                       (Inhalation absorption                             based on decreased
                                        rate = 100%).                                     body weight/body-
                                                                                          weight gain,
                                                                                          alterations in some
                                                                                          hematology (decreased
                                                                                          platelets (both
                                                                                          sexes)) and clinical
                                                                                          chemistry (decreased
                                                                                          T3 (females) and T4
                                                                                          (both sexes))
                                                                                          parameters, and
                                                                                          cataract formation.
----------------------------------------------------------------------------------------------------------------
Long-term inhalation                   Inhalation (or oral)     LOC for MOE = 1,000      Rat chronic toxicity
(Several months to lifetime).........   study                   (Residential)..........   study
(Residential)........................   NOAEL = 5 mg/kg/day...                           LOAEL = 75 mg/kg/day
                                       (Inhalation absorption                             based on decreased
                                        rate = 100%).                                     body-weight gain
                                                                                          (females) and food
                                                                                          consumption (females),
                                                                                          alterations in
                                                                                          hematology (decreased
                                                                                          RBC, HCT, and HGB
                                                                                          (females), platelets
                                                                                          (both sexes)) and
                                                                                          clinical chemistry
                                                                                          parameters (increased
                                                                                          creatinine (both
                                                                                          sexes), alanine and
                                                                                          aspartate
                                                                                          aminotransferases
                                                                                          (males), alkaline
                                                                                          phosphatase (both
                                                                                          sexes), decreased T4
                                                                                          (both sexes), glucose
                                                                                          (females), cholesterol
                                                                                          (both sexes), and
                                                                                          triglycerides
                                                                                          (females)), increased
                                                                                          thyroid weights (both
                                                                                          sexes at study
                                                                                          termination), and
                                                                                          decreased testes and
                                                                                          ovarian weights.
----------------------------------------------------------------------------------------------------------------
Cancer                                  Not likely to pose a cancer risk based on the lack of carcinogenicity in
(Oral, dermal, inhalation)...........        a rat carcinogenicity study and a mouse carcinogenicity study.
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.142) for the residues of 2,4-D, in or on a 
variety of raw agricultural commodities, fish, meat, milk, poultry, and 
eggs. Risk assessments were conducted by EPA to assess dietary 
exposures from 2,4-D in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    In conducting the acute dietary risk assessment EPA used Lifeline 
Model Version 2.0 (Lifeline) and the Dietary Exposure Evaluation Model 
software with the Food Commodity Intake Database (DEEM-FCID, Version 
1.33). DEEM incorporates consumption data from United States Department 
of Agriculture's (USDA) Continuing

[[Page 43304]]

Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998. 
Lifeline uses food consumption data from USDA's CSFII from 1994-1996 
and 1998. Lifeline uses recipe files contained within the program to 
relate raw agricultural commodities (RACs) to foods ``as-eaten.'' 
Lifeline converts the RAC residues into food residues by randomly 
selecting a RAC residue value from the ``user defined'' residue 
distribution (created from the residue, percent crop treated (PCT), and 
processing factors data), and calculating a net residue for that food 
based on the ingredients' mass contribution to that food item. The 
following assumptions were made for the acute exposure assessments: For 
the acute analyses, tolerance-level residues were assumed for most food 
commodities with 2,4-D tolerances except the highest-field trial 
residue value was used for citrus commodities, and it was assumed that 
all of the crops included in the analysis were treated. One half of the 
average Level of Detection (LOD) from Pesticide Data Program (PDP) 
monitoring data was used as the milk exposure value because no milk 
sample contained detectable 2,4-D residues over several years of PDP. 
The PCT data were not used in the acute risk assessment.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used Lifeline and DEEM-FCID, Version 1.33. DEEM 
incorporates consumption data from USDA's CSFII, 1994-1996 and 1998. 
Lifeline uses food consumption data from the USDA's CSFII from 1994-
1996 and 1998. Lifeline uses recipe files contained within the program 
to relate RACs to foods ``as-eaten.'' Lifeline converts the RAC 
residues into food residues by randomly selecting a RAC residue value 
from the ``user defined'' residue distribution (created from the 
residue, PCT, and processing factors data), and calculating a net 
residue for that food based on the ingredients' mass contribution to 
that food item. The following assumptions were made for the chronic 
exposure assessments: For the chronic analyses, tolerance-level 
residues were assumed for food commodities with 2,4-D tolerances except 
averages of field trial data and processing study factors were used for 
small grains, citrus, and sugarcane sugar and molasses; percentage of 
crop treated information was used for most commodities; and the highest 
observed groundwater monitoring concentration (15 parts per billion 
(ppb)) in drinking water is used to calculate the aggregate risk. One 
half of the average LOD from PDP monitoring data was used as the milk 
exposure value because no milk sample contained detectable 2,4-D 
residues over several years of PDP.
    iii. Anticipated residue and percent crop treated (PCT) 
information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use 
available data and information on the anticipated residue levels of 
pesticide residues in food and the actual levels of pesticide chemicals 
that have been measured in food. If EPA relies on such information, EPA 
must pursuant to section 408(f)(1) of FFDCA require that data be 
provided 5 years after the tolerance is established, modified, or left 
in effect, demonstrating that the levels in food are not above the 
levels anticipated. Following the initial data submission, EPA is 
authorized to require similar data on a time frame it deems 
appropriate. For the present action, EPA will issue such data call-ins 
for information relating to anticipated residues as are required by 
section 408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of 
FFDCA. Such data call-ins will be required to be submitted no later 
than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if the Agency can make the following findings:
    Condition 1, that the data used are reliable and provide a valid 
basis to show what percentage of the food derived from such crop is 
likely to contain such pesticide residue.
    Condition 2, that the exposure estimate does not underestimate 
exposure for any significant subpopulation group.
    Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information as follows:

                         Table 3.--Percent Crop Treated (PCT) for Registered 2,4-D Uses
----------------------------------------------------------------------------------------------------------------
                 Crop                          Acreage                    PCT                 Lbs./acre (ai)
----------------------------------------------------------------------------------------------------------------
Alfalfa                                23,704,000               0.6                      69,000
----------------------------------------------------------------------------------------------------------------
Almonds                                583,000                  10                       70,000
----------------------------------------------------------------------------------------------------------------
Apples                                 477,000                  36                       250,000
----------------------------------------------------------------------------------------------------------------
Apricots                               23,0008                  8                        3,000
----------------------------------------------------------------------------------------------------------------
Asparagus                              77,000                   15                       20,000
----------------------------------------------------------------------------------------------------------------
Barley                                 5,914,000                43                       1,290,000
----------------------------------------------------------------------------------------------------------------
Beans/peas, dry                        2,133,000                3                        30,000
----------------------------------------------------------------------------------------------------------------
Beans/peas, vegetable                  677,000                  1.2                      8,000
----------------------------------------------------------------------------------------------------------------
Blueberries                            62,000                   0.5                      200
----------------------------------------------------------------------------------------------------------------
Canola/rapeseed                        1,281,000                2                        11,000
----------------------------------------------------------------------------------------------------------------
Cherries                               105,000                  24                       30,000
----------------------------------------------------------------------------------------------------------------
Corn, field                            75,241,000               12                       3,660,000
----------------------------------------------------------------------------------------------------------------

[[Page 43305]]

 
Cotton                                 13,793,000               3                        234,000
----------------------------------------------------------------------------------------------------------------
Cranberries                            32,000                   9                        6,000
----------------------------------------------------------------------------------------------------------------
Fallow, Summer                         22,879,000               10                       2,003,000
----------------------------------------------------------------------------------------------------------------
Flax                                   143,000                  9                        7,000
----------------------------------------------------------------------------------------------------------------
Filberts                               31,000                   58                       35,000
----------------------------------------------------------------------------------------------------------------
Grapefruit                             165,000                  19                       1,100
----------------------------------------------------------------------------------------------------------------
Grapes                                 1,006,000                2                        13,000
----------------------------------------------------------------------------------------------------------------
Hay, other                             33,777,000               8                        1,824,000
----------------------------------------------------------------------------------------------------------------
Lemons                                 72,000                   1.5                      1,100
----------------------------------------------------------------------------------------------------------------
Millet                                 318,000                  23                       35,000
----------------------------------------------------------------------------------------------------------------
Nectarines                             34,000                   10                       1,000
----------------------------------------------------------------------------------------------------------------
Oats                                   4,036,000                19                       380,000
----------------------------------------------------------------------------------------------------------------
Oranges                                940,000                  7                        20,000
----------------------------------------------------------------------------------------------------------------
Pasture/rangeland                      469,536                  5                        16,371,000
----------------------------------------------------------------------------------------------------------------
Peaches                                158,000                  12                       25,000
----------------------------------------------------------------------------------------------------------------
Peanuts                                1,416,000                4                        30,000
----------------------------------------------------------------------------------------------------------------
Pears                                  70,000                   14                       15,000
----------------------------------------------------------------------------------------------------------------
Pecans                                 496,000                  5                        20,000
----------------------------------------------------------------------------------------------------------------
Pistachios                             100,000                  5                        5,000
----------------------------------------------------------------------------------------------------------------
Potatoes                               1,291,000                2                        4,000
----------------------------------------------------------------------------------------------------------------
Prunes/plums                           151,000                  17                       25,000
----------------------------------------------------------------------------------------------------------------
Rice                                   3,231,000                17                       527,000
----------------------------------------------------------------------------------------------------------------
Rye                                    298,000                  21                       30,000
----------------------------------------------------------------------------------------------------------------
Seed crops                             1,383,000                36                       275,000
----------------------------------------------------------------------------------------------------------------
Sorghum                                9,077,000                16                       667,000
----------------------------------------------------------------------------------------------------------------
Soybeans                               70,993,000               7                        2,410,000
----------------------------------------------------------------------------------------------------------------
Strawberries                           47,000                   7                        5,000
----------------------------------------------------------------------------------------------------------------
Sugarcane                              939,000                  53                       490,000
----------------------------------------------------------------------------------------------------------------
Sunflowers                             2,040,000                4                        50,000
----------------------------------------------------------------------------------------------------------------
Sweet Corn                             678,000                  5                        15,000
----------------------------------------------------------------------------------------------------------------
Walnuts                                229,000                  9                        40,000
----------------------------------------------------------------------------------------------------------------
Wheat, Spring                          18,903,000               4                        50,000
----------------------------------------------------------------------------------------------------------------
Wheat, Winter                          42,403,000               24                       5,140,000
----------------------------------------------------------------------------------------------------------------
Wild rice                              26,000                   10                       600
----------------------------------------------------------------------------------------------------------------

    EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available Federal, State, and private market survey data for that use, 
averaging by year, averaging across all years, and rounding up to the 
nearest multiple of five. EPA uses a maximum PCT for acute dietary risk 
analysis. The

[[Page 43306]]

maximum PCT figure is the single-maximum value reported overall from 
available Federal, State, and private market survey data on the 
existing use, across all years, and rounded up to the nearest multiple 
of five.
    The Agency believes that the three conditions listed Unit 
III.C.1.iii. have been met. With respect to Condition 1 of Unit 
III.C.1.iii. , PCT estimates are derived from Federal and private 
market survey data, which are reliable and have a valid basis. The 
Agency is reasonably certain that the percentage of the food treated is 
not likely to be an underestimation. As to Conditions 2 and 3 of Unit 
III.C.1.iii., regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which 2,4-D may be 
applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for 2,4-D in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of 2,4-D.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The Screening Concentration in Ground Water Modeling System 
(SCI-GROW) model is used to predict pesticide concentrations in shallow 
ground water. For a screening-level assessment for surface water EPA 
will use FIRST (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. Both FIRST and PRZM/
EXAMS incorporate an index reservoir environment, and both models 
include a percent crop area factor as an adjustment to account for the 
maximum percent crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of 2,4-D for 
acute exposures are estimated to be 118 ppb for surface water. The EECs 
for chronic exposures are estimated to be 23 ppb for surface water. 
Based on actual monitoring of 2,4-D the acute and chronic exposures are 
15 ppb for ground water.
    3. From non-dietary exposure. The term``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    2,4-D is currently registered for use on the following residential 
non-dietary sites: Turf. The risk assessment was conducted using the 
following residential exposure assumptions: Homeowners (or others) may 
be exposed to 2,4-D while treating their lawns. All homeowner-use 
products are available in liquid or granular form. 2,4-D is applied 
using hose-end sprayers, pump sprayers, ready-to-use sprayers, 
broadcast spreaders, belly grinders, and hand application, either 
before or after seasonal weed emergence, at a rate up to 1.5 lbs./ai. 
2,4-D uses in the residential setting include applications to home 
lawns. The following scenarios were assessed for residential post 
application risks: Toddlers playing on treated turf, adults performing 
yard work on treated turf, and adults playing golf on treated turf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to 2,4-D and any other 
substances and 2,4-D does not appear to produce a toxic metabolite 
produced by other substances. EPA has also evaluated comments submitted 
that suggested there might be a common mechanism among 2,4-D and other 
named pesticides that cause brain effects. EPA concluded that the 
evidence did not support a finding of common mechanism for 2,4-D and 
the named pesticides. For the purposes of this tolerance action, 
therefore, EPA has not assumed that 2,4-D has a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the policy 
statements released by EPA's OPP concerning common mechanism 
determinations and procedures for cumulating effects from substances 
found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using UFs (safety) in calculating a dose level 
that poses no appreciable risk to humans. In applying this provision, 
EPA either retains the default value of 10X when reliable data do not 
support the choice of a different factor, or, if reliable data are 
available, EPA uses a different additional safety factor value based on 
the use of traditional uncertainty factors and/or special FQPA safety 
factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The toxicity database for 
2,4-D includes acceptable developmental and reproductive toxicity 
studies. Developmental toxicity studies were conducted in both rats and 
rabbits for most 2,4-D forms. There is qualitative evidence of 
susceptibility in the rat developmental toxicity study with 2,4-D acid 
and DEA salt where fetal effects (skeletal abnormalities) were observed 
at a dose level that produced less severe

[[Page 43307]]

maternal toxicity (decreased body-weight gain and food consumption). 
There is no evidence of increased (quantitative or qualitative) 
susceptibility in the prenatal developmental toxicity study in rabbits 
or in the 2-generation reproduction study in rats on 2,4-D. Regarding 
the 2,4-D amine salt and ester forms, no evidence of increased 
susceptibility (quantitative or qualitative) was observed in the 
prenatal developmental toxicity study in rat and rabbits (except for 
2,4-D DEA) dosed with any of the amine salts or esters of 2,4-D. There 
is evidence of increased susceptibility (qualitative) in the prenatal 
developmental study in rabbits for 2,4-D DEA salt. After establishing 
developmental toxicity endpoints to be used in the risk assessment with 
traditional uncertainty factors (10x for interspecies variability and 
10x for intraspecies variability), the Agency has no residual concerns 
for the effects seen in the developmental toxicity studies.
    3. Conclusion. EPA has concerns with regard to the completeness of 
the toxicity database. A developmental neurotoxicity (DNT) study in 
rats is required for 2,4-D. The Agency concluded that there is a 
concern for developmental neurotoxicity resulting from exposure to 2,4-
D. There is evidence of neurotoxicity, including clinical signs such as 
ataxia and decreased motor activity in pregnant rabbits following 
dosing during gestation days 6-15 in studies on 2,4-D itself and 2,4-D 
amine salts and esters, and tremors in dogs that died on test following 
repeat exposure to 2,4-D. Incoordination and slight gait abnormalities 
(forepaw flexing or knuckling) were also observed following dosing in 
the acute neurotoxicity study with 2,4-D. There is also evidence of 
developmental toxicity, as discussed above. In addition, the Agency 
determined that a repeat two generation reproduction study using a new 
protocol is required to address concerns for endocrine disruption 
(thyroid and immunotoxicity measures). Examination of the existing 
database does not reveal a basis for concluding that aggregate exposure 
to 2,4-D will be safe for infants and children in the absence of the 
additional 10X FQPA safety factor. Therefore, the Agency determined 
that the 10X FQPA safety factor, in the form of a database uncertainty 
factor (UFDB), will be retained.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 2,4-D 
will occupy 18% (DEEM) of the aPAD for the U.S. population, 43 % 
(Lifeline) of the aPAD for females 13-49 years old, and 31% (DEEM) of 
the aPAD for children 1-2 years old.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 2,4-D 
from food and drinking water will utilize 10% (DEEM) of the cPAD for 
the U.S. population, 24% (DEEM) of the cPAD for all Infants (< 1 year 
old), and 18% (DEEM) of the cPAD for children 1-2 years old. There are 
no residential uses for 2,4-D that result in chronic residential 
exposure to 2,4-D.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    2,4-D is currently registered for use that could result in short-
term residential exposure. Short-term aggregate risks were calculated 
only for females 13-49 and children 1-6 because these population 
subgroups have the highest exposure and are protective of the other 
subgroups. The short-term aggregate MOEs are presented in Table 4 of 
this unit and indicate that the short-term risks are not of concern 
because the MOEs equal or exceed the target MOE of 1,000.

                                         Table 4.--Aggregate Short-Term MOEs Including Turf Exposures for 2,4-D
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Chronic
                                                                                         Estimated
                               Turf application    Chronic food     Short-term turf   Drinking Water    Drinking water     Aggregate
     Population subgroup       rate  (lbs. (ae)/  exposure   (mg/  exposure  (mg/kg/   Concentration    exposure  (mg/   exposure  (mg/   Aggregate MOE
                                      ai)             kg/day)            day)         (EDWC)  ([mu]g/      kg/day)          kg/day)
                                                                                          liter)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-49                  1.5               0.000195          0.024             15                0.00050          0.0247           1,000
------------------------------
Children 1-6                   1.5               0.000424          0.021             15                0.0010           0.0224           1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Though residential exposure could occur with the use of 2,4-D, 
intermediate-term residential risks were not calculated for any of the 
residential scenarios because there are no intermediate term 
residential scenarios; residential turf application exposures are 
expected to be short-term in duration for broadcast treatments because 
the label allows only two broadcast treatments per year and because 
2,4-D dissipates rapidly from the turf after application. The turf 
transferable residue studies indicated that the 2,4-D half life ranged 
from less than 1 day to 2.8 days.
    5. Aggregate cancer risk for U.S. population. The aggregate cancer 
risk was not calculated for 2,4-D based on the lack of carcinogenicity 
in a rat carcinogenicity study and a mouse carcinogenicity study. The 
endpoint selected for cPAD is protective of the possible carcinogenic 
activity of 2,4-D.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to 2,4-D residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromotography) is available 
to enforce the tolerance expression. The method may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
e-mail address: [email protected].

B. International Residue Limits

    The Codex Alimentarius Commission has established several maximum 
residue limits (MRLs) for residues of 2,4-D in/on various plant and 
animal commodities. No Codex MRLs have been established, however, for 
the crops

[[Page 43308]]

covered by this tolerance action: Hop, soybean, and wild rice.

C. Conditions

    A developmental neurotoxicity study, a subchronic inhalation 
toxicity study, a repeat 2-generation reproduction study (using the new 
protocol) addressing concerns for endocrine disruption (thyroid and 
immunotoxicity measures), grape processing study, wheat hay field 
trials, and limited irrigated crop studies (sugar beet roots and tops 
and strawberries) are requested.

D. Response to Comments

    Public comments were received from B. Sachau who objected to the 
proposed tolerances because of the amounts of pesticides already 
consumed and carried by the American population. She further indicated 
that testing conducted on animals have absolutely no validity and are 
cruel to the test animals. B. Sachau's comments contained no scientific 
data or evidence to rebut the Agency's conclusion that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to 2,4-D, including all anticipated dietary exposures and all other 
exposures for which there is reliable information. EPA has responded to 
B. Sachau's generalized comments on numerous previous occasions. (See 
the Federal Register of January 7, 2005 (70 FR 1349, 1354) (FRL-7691-4) 
and the Federal Register of October 29, 2004 (69 FR 63083, 63096) (FRL-
7681-9).

V. Conclusion

    Therefore, the tolerance is established for residues of 2,4-D in or 
on hop at 0.05 ppm, soybean at 0.02 ppm, and wild rice at 0.1 ppm.

VI. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0038 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before September 
26, 2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350,1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0038, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to:[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 issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501  et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety

[[Page 43309]]

Risks (62 FR 19885, April 23, 1997). This action does not involve any 
technical standards that would require Agency consideration of 
voluntary consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and 
exemptions that are established on the basis of a petition under 
section 408(d) of FFDCA, such as the tolerance in this final rule, do 
not require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. 
In addition, the Agency has determined that this action will not have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: July 20, 2005.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.142 is amended by alphabetically adding commodities to 
the table in paragraph (a)(2) introductory text and removing and 
reserving paragraph (a)(11) to read as follows:


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

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Hop........................................................         0.05
                                * * * * *
Rice, wild.................................................          0.1
                                * * * * *
Soybean....................................................         0.02
                                * * * * *
------------------------------------------------------------------------

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* * * * *

[FR Doc. 05-14886 Filed 7-26-05; 8:45 am]
BILLING CODE 6560-50-S