[Federal Register Volume 69, Number 185 (Friday, September 24, 2004)]
[Rules and Regulations]
[Pages 57207-57216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21500]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0293; FRL-7680-2]


Lactofen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
lactofen in or on cotton undelinted seed, cotton gin byproducts, and 
peanut. Valent U.S.A. Corporation 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 September 24, 2004. Objections and 
requests for hearings must be received on or before November 23, 2004.

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-2004-0293. 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., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material,

[[Page 57208]]

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 
<greek-i>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 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address: 
<a href="/cdn-cgi/l/email-protection#92fffbfefef7e0bcf8fdf3fcfcf7d2f7e2f3bcf5fde4"><span class="__cf_email__" data-cfemail="ff929693939a8dd195909e91919abf9a8f9ed1989089">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
    <bullet> Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
    <bullet> Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
    <bullet> 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 at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of January 29, 2003 (68 FR 4475) (FRL-7287-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
8F3591 and 9F3798) by Valent U.S.A. Corporation, 1333 North California 
Blvd., Suite 600, Walnut Creek, CA 94596-8025. The petitions requested 
that 40 CFR 180.432 be amended by establishing tolerances for residues 
of the herbicide lactofen, 1-(carboethoxy)ethyl 5-[2-chloro-4-
(trifluoromethyl)phenoxy]-2-nitrobenzoate, in or on cottonseed at 0.01 
part per million (ppm), cotton gin byproducts at 0.02 ppm (PP 9F3798), 
and peanut nutmeats at 0.01 ppm (PP 8F3591). That notice included a 
summary of the petitions prepared by Valent U.S.A. Corporation, the 
registrant. There were no comments received in response to the notice 
of filing.
    The proposed and established tolerances are corrected to conform to 
the Food and Feed Commodity Vocabulary Database (http://www.epa.gov/pesticides/foodfeed/) and to lower the established tolerances for snap 
bean and soybean to 0.01 ppm as required by the Lactofen Tolerance 
Reassessment (http://www.epa.gov/pesticides/reregistration/lactofen/) 
to read as follows: Tolerances for residues of the herbicide lactofen, 
1-(carboethoxy)ethyl 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-
nitrobenzoate, in or on beans, snap, succulent (excluding limas) at 
0.01 ppm; cotton, undelinted seed at 0.01 ppm; cotton, gin byproducts 
at 0.02 ppm; peanut at 0.01 ppm; and soybean, seed at 0.01 ppm.
    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 tolerances for residues of lactofen on cotton, 
undelinted seed at 0.01 ppm; cotton, gin byproducts at 0.02 ppm; and 
peanut at 0.01 ppm ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by lactofen 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.

[[Page 57209]]



                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 13-Week oral toxicity--     NOAEL = 14.1 milligrams/kilogram/day (mg/kg/
                                          rodents (rat)               day).
                                                                     LOAEL = 73.7 mg/kg/day based on decreased
                                                                      body weight, increased incidence of
                                                                      anemia, increased levels of serum enzymes
                                                                      and bilirubin, decreased levels of
                                                                      glucose, increased liver weights, and
                                                                      increased incidence of microscopic liver
                                                                      lesions.
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity--      NOAEL = not established.
                                          rodents (mouse)            LOAEL = 28.6 mg/kg/day based on changes
                                                                      clinical chemistry parameters, increases
                                                                      in organ weight, and histopathological
                                                                      findings.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL = 50 mg/kg/day.
                                          rodents (rat)              Maternal LOAEL = 150 mg/kg/day based on
                                                                      signs of toxicity (excessive salivation,
                                                                      lethargy, dried red material around the
                                                                      nares and inguinal regions) and
                                                                      statistically significant decreases in
                                                                      body weight gain.
                                                                     Developmental NOAEL = 50 mg/kg/day.
                                                                     Developmental LOAEL = 150 mg/kg/day based
                                                                      on decreased fetal weight and skeletal
                                                                      abnormalities (increased incidence of bent
                                                                      ribs and/or limb bones) and reduced
                                                                      ossification of vertebral arches.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL >= 20 mg/kg/day.
                                          nonrodents (rabbit)        Maternal LOAEL > 20 mg/kg/day Highest Dose
                                                                      Tested (HDT).
                                                                     Developmental NOAEL >= 20 mg/kg/day.
                                                                     Developmental LOAEL > 20 mg/kg/day HDT.
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 2.6 mg/kg/day.
                                          effects                    Parental/Systemic LOAEL = 26.2 mg/kg/day
                                                                      based on mortality and decreased male
                                                                      fertility.
                                                                     Reproductive NOAEL = 2.6 mg/kg/day.
                                                                     Reproductive LOAEL = 26.2 mg/kg/day based
                                                                      on decreased male fertility.
                                                                     Offspring NOAEL = 2.6 mg/kg/day.
                                                                     Offspring LOAEL = 26.2 mg/kg/day based on
                                                                      reduced pup body weigh and decreases in
                                                                      the absolute and relative spleen weight.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity--dogs      NOAEL = 0.79 mg/kg/day.
                                                                     LOAEL = 3.96 mg/kg/day based on increased
                                                                      incidence of proteinaceous casts in the
                                                                      kidneys, and statistically significant
                                                                      increases in the absolute weights of the
                                                                      thyroid and adrenal glands in males.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined Chronic toxicity   NOAEL = 2 mg/kg/day.
                                          Carcinogenicity--rats      LOAEL = 19 mg/kg/day based on statistically
                                                                      significant increases in the incidence of
                                                                      mottled or discolored livers and changes
                                                                      in clinical chemistry.
                                                                     No evidence of carcinogenicity.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity--mice       NOAEL = not established.
                                                                     LOAEL = 1.4 mg/kg/day Lowest Dose Tested
                                                                      (LDT) based on hepatocytomegaly, increased
                                                                      liver weight, and increased sinusoidal
                                                                      cell pigmentation.
                                                                     Likely to be carcinogenic to humans at high
                                                                      enough doses to cause these biochemical
                                                                      and histopathological effects (peroxisome
                                                                      proliferation) in the livers of rodents
                                                                      but unlikely to be carcinogenic at doses
                                                                      below those causing these changes.
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation in S.         No cytotoxicity evident at 50 [mu]g (gram)/
                                          typhimurium/                plate in the absence or presence of
                                          mammalianmicrosome          metabolic activation. PPG-844 induced a
                                          mutagenicity assay.         dose-relatedincrease in revertant colonies
                                                                      of strain TA1538 in the absence of S9
                                                                      activation; however, no effect seen in
                                                                      strain TA98 (derived from TA1538).
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation in S.         Cytotoxicity was not evident for any strain
                                          typhimurium/mammalian       up to the limit dose (5,000Fg/plate). No
                                          microsome mutagenicity      evidence of PPG-844 induced mutagenic
                                          assay                       effect.
----------------------------------------------------------------------------------------------------------------
870.5375                                 In vitro cytogenetic assay  No evidence of clastogenic effect in the
                                          with Chinese Hamster        presence or absence of S9 activation.
                                          Ovary (CHO) cells
----------------------------------------------------------------------------------------------------------------
870.5375                                 Mammalian cells in culture  No evidence of cytotoxicity at any dose
                                          gene mutation in CHO        tested. No clear indication of mutagenic
                                          cells                       effect in the presence or absence of S9
                                                                      activation.
----------------------------------------------------------------------------------------------------------------
870.5550                                 Unscheduled DNA Synthesis   No unscheduled DNA synthesis.
----------------------------------------------------------------------------------------------------------------

[[Page 57210]]

 
                                         In vivo DNA covalent        A covalent binding index of 1.4 <plus-
                                          binding in mouse liver      minus> 0.6 was determined for lactofen.
                                                                      This suggests a low binding to mouse
                                                                      hepatic DNA may occur. This finding could
                                                                      not be attributed solely to DNA binding
                                                                      since some protein-binding of the parent
                                                                      compound and/or metabolite could be
                                                                      occurring.
----------------------------------------------------------------------------------------------------------------
                                         Analysis of biochemical     Aryl CoA oxidase, catalase, and carnitine
                                          and microscopic             acetlytransferase activities not affected
                                          parameters in Chimpanzee    by treatment. No nuclear enlargement,
                                          liver                       cytoplasmic eosinophilia, or hepertrophy
                                                                      observed in liver biopsies after 0, 1, and
                                                                      3 months of treatment. Slight + response
                                                                      for peroxisomal staining (brown
                                                                      stippling).
----------------------------------------------------------------------------------------------------------------
                                         Results of the analysis of  Catalase and CN-insensitive palmiloyl CoA
                                          biochemical parameters in   oxidase increased. Rats (2,000 ppm) and
                                          mouse and rat liver         mice (50 ppm) showed increased nuclear
                                         Following Exposure to PPG-   enlargement, cytoplasmic eosinophilia,
                                          844.                        hypertrophy, and peroxisomes in number of
                                                                      peroxisomes.
                                                                     The NOAEL for this study was established at
                                                                      0.3 mg/kg/day, based on increased
                                                                      activities of liver enzymes and increased
                                                                      incidence of liver histopathological
                                                                      findings at the LOAEL of 1.5 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
                                         Measurement of peroxisome   Concentration-dependent increase in CN-
                                          proliferation in primary    insensitive palmitoyl CoA oxidase
                                          rat hepatocytes induced     activities with each of the metabolites.
                                          by PPG-844 and five of     EM: Lactofen (0.01 millimole (mM))
                                          its metabolites             increased number of peroxisomes and
                                                                      glycogen aggregates. Other metabolites
                                                                      showed occasional peroxisomes.
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    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 uncertainty factors 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 uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the 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 and children primarily as a result of the 
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<SUP>-</SUP>\5\), one in a million (1 X 10<SUP>-</SUP>\6\), or one in 
ten million (1 X 10<SUP>-</SUP>\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 (MOE<INF>cancer</INF> = point of departure/exposures) is 
calculated.
    A summary of the toxicological endpoints for lactofen used for 
human risk assessment is shown in Table 2 of this unit:

[[Page 57211]]



       Table 2.--Summary of Toxicological Dose and Endpoints for lactofen 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 = 50 mg/kg/day UF  Special FQPA SF = 3      Rat Developmental
(Females 13-50 years of age).........   = 100 Acute RfD = 0.5    aPAD = acute RfD/        Toxicity Study
                                        mg/kg/day                Special FQPA SF = 0.17  LOAEL = 150 mg/kg/day
                                                                 mg/kg/day                based on decreased
                                                                                          fetal weight and
                                                                                          skeletal
                                                                                          abnormalities.
----------------------------------------------------------------------------------------------------------------
Acute Dietary                           An endpoint attributable to a single dose (exposure) was not identified
(General population including infants   from the available studies, including the developmental toxicity studies
 and children).                                                   in rats and rabbits.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary                        NOAEL = 0.79 mg/kg/day   Special FQPA SF = 1      Dog chronic toxicity
(All populations)....................   UF = 100 Chronic RfD =   cPAD = chronic RfD/     LOAEL = 3.96 mg/kg/day
                                        0.008 mg/kg/day          Special FQPA SF =        based on increased
                                                                 0.008 mg/kg/day          incidence of
                                                                                          proteinaceous casts in
                                                                                          the kidneys, and
                                                                                          statistically
                                                                                          significant increases
                                                                                          in the absolute
                                                                                          weights of the thyroid
                                                                                          and adrenal glands in
                                                                                          males.
----------------------------------------------------------------------------------------------------------------
Cancer                                  Lactofen acts via a peroxisome proliferation mechanism of action. Likely
(Oral, dermal, inhalation)...........       to be carcinogenic to humans at high enough doses to cause these
                                         biochemical and histopathological effects (peroxisome proliferation) in
                                          the livers of rodents but unlikely to be carcinogenic at doses below
                                          those causing these changes. Lactofen is considered to be a threshold
                                        carcinogen. NOAEL = 0.3 mg/kg/day based on increased activities of liver
                                         enzymes and increased incidence of liver histopathological findings at
                                                               the LOAEL of 1.5 mg/kg/day.
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.432) for the residues of lactofen in or on 
succulent snap bean and soybeans. Risk assessments were conducted by 
EPA to assess dietary exposures from lactofen in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide, if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure.
    The Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated 
the individual food consumption as reported by respondents in the USDA 
1989-1992 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII) and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the acute exposure assessments: 
The acute dietary analysis uses average food residue values from field 
trial studies and percent crop treated (PCT) information.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the DEEM\TM\ analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 CSFII and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the chronic exposure assessments: The chronic 
dietary analysis utilized average residue values based on field trial 
studies, concentration factors from processing studies, and PCT 
information.
    iii. Cancer. In conducting this cancer dietary risk assessment, the 
DEEM\TM\ analysis evaluated the individual food consumption as reported 
by respondents in the USDA 1989-1992 CSFII and accumulated exposure to 
the chemical for each commodity. The following assumptions were made 
for the chronic exposure assessments: The chronic dietary analysis 
utilized the average consumption values for food and average residue 
values for those foods over a 70-year lifetime.
    iv. Anticipated residue and 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 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. As 
required by section 408(b)(2)(E) of FFDCA, EPA will issue a data call-
in for information relating to anticipated residues to be submitted no 
later than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) 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.--PCT for Registered Lactofen Uses
------------------------------------------------------------------------
                   Crop                                  PCT
------------------------------------------------------------------------
Cotton                                      5
Succulent snap beans                        5
Soybeans                                    5
------------------------------------------------------------------------

    The Agency believes that the three conditions listed in this unit 
have been met. With respect to Condition 1, PCT estimates are derived 
from Federal and private market survey data, which are

[[Page 57212]]

reliable and have a valid basis. EPA uses a weighted average PCT for 
chronic dietary exposure estimates. This weighted average PCT figure is 
derived by averaging State-level data for a period of up to 10 years, 
and weighting for the more robust and recent data. A weighted average 
of the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which lactofen 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 lactofen 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 lactofen.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) to estimate pesticide concentrations in surface 
water and Screening Concentration in Ground Water (SCI-GROW), which 
predicts pesticide concentrations in ground water. In general, EPA will 
use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) 
for a screening-level assessment for surface water. The GENEEC model is 
a subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes 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.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD. 
Instead drinking water levels of comparison (DWLOCs) are calculated and 
used as a point of comparison against the model estimates of a 
pesticide's concentration in water. DWLOCs are theoretical upper limits 
on a pesticide's concentration in drinking water in light of total 
aggregate exposure to a pesticide in food, and from residential uses. 
Since DWLOCs address total aggregate exposure to lactofen they are 
further discussed in the aggregate risk sections in Unit III.E.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of lactofen 
for acute exposures are estimated to be 0.39 parts per billion (ppb) 
for surface water and 0.006 ppb for ground water. The EECs for chronic 
exposures are estimated to be 0.008 ppb for surface water and 0.006 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).
    Lactofen is not registered for use on any sites that would result 
in residential exposure.
    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.''
    Lactofen is a member of the diphenyl ether group of herbicides, 
which includes acifluorfen (lactofen's major metabolite), nitrofen, 
oxyfluorfen, and fomefasen. In addition, lactofen degrades to 
acifluorfen in the environment. The Agency has evidence that these 
compounds induce similar toxic effects but has not yet determined 
whether these compounds exhibit a common mechanism of toxicity. The 
Agency defers the cumulative risk assessment of lactofen and the other 
diphenyl ethers to a later date. For the purposes of this tolerance 
action, therefore, EPA has not assumed that lactofen 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 web site 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 uncertainty (safety) factors 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

[[Page 57213]]

factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The toxicology database for 
lactofen is complete for FQPA purposes except for a developmental 
toxicity study in rabbits. Based on the quality of the exposure data, 
EPA determined that the 10X SF to protect infants and children should 
be reduced to 3X and still be protective for any possible toxicity to 
infants and children which might be observed in the missing rabbit 
developmental study. The FQPA factor was reduced based on the 
following:
    i. The available data provide no indication of quantitative or 
qualitative increased susceptibility from in utero and/or postnatal 
exposure to lactofen in rats.
    ii. The available rabbit developmental toxicity study was 
considered unacceptable because dosing was not done at a high enough 
level to observe significant toxicity. However, the study provides 
sufficient information to indicate that the NOAEL for both maternal and 
developmental effects will be 20 mg/kg/day (the HDT that elicited no 
significant toxicity) or higher. The acute dietary risk assessment for 
which the missing rabbit developmental study could potentially be used 
currently uses a NOAEL = 50 mg/kg/day from the rat developmental study. 
Risk estimates using a new developmental rabbit study could increase at 
most by a factor of 2.5X (50/20 mg/kg/day); therefore, a 3X UF is 
protective for any toxicity which might be observed in the outstanding 
rabbit developmental study.
    iii. Endpoints for other risk assessments (chronic and cancer) 
utilize NOAELs significantly lower than 20mg/kg/day; therefore the 
developmental rabbit study will not affect these assessments. Based on 
mechanistic studies with transgenic mice, lactofen has been classified 
as a non-genotoxic hepatocarcinogen in rodents with peroxisome 
proliferation being a plausible mode of action. Lactofen is currently 
classified as likely to be carcinogenic to humans at high enough doses 
to cause the biochemical and histopathological changes in the liver of 
rodents, but unlikely to be carcinogenic to humans below those doses 
causing these changes. A non-linear methodology (MOE) was applied for 
the estimation of human cancer risk using a NOAEL of 0.3 mg/kg/day. 
Generally, for threshold cancer effects where the mode of action is 
well understood, the general margin of exposure that indicates a 
reasonable certainty of no harm would be 100 (10X for intraspecies 
extrapolation and 10X for interspecies variation). Given that the % 
cPAD (Food) is < 0.1 % and the cancer MOE is 300,000 for the U.S. 
population, a 100 fold safety factor would be protective for chronic 
and cancer toxicity.
    iv. Adequate actual data, surrogate data, and/or modeling outputs 
are available to satisfactorily assess food exposure and to provide a 
screening level drinking water exposure assessment (there are currently 
no residential uses). Since there is uncertainty associated with the 
data gap for a developmental toxicity study in rabbits with lactofen 
the safety factor is reduced to 3X.
    3. Conclusion. There is a complete toxicity data base for lactofen 
except for a developmental toxicity study in rabbits and exposure data 
are complete or are estimated based on data that reasonably accounts 
for potential exposures.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against EECs. DWLOC values are 
not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food and residential 
uses. In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)]. This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
lactofen will occupy <0.1% of the aPAD for females 13 years and older. 
In addition, there is potential for acute dietary exposure to lactofen 
in drinking water. After calculating DWLOCs and comparing them to the 
EECs for surface and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the aPAD, as shown in Table 4 of this unit:

                                           Table 4.--Aggregate Risk Assessment for Acute Exposure to Lactofen
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Surface Water EEC       Ground Water EEC
        Population Subgroup               aPAD (mg/kg)            % aPAD (Food)              (ppb)                  (ppb)            Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13 years and older           0.17                    <0.1%                   0.39                   0.006                  5,100
--------------------------------------------------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to lactofen 
from food will utilize <0.1% of the cPAD for the U.S. population, <0.1 
% of the cPAD for children 1-6, and <0.1% of the cPAD for Females 13 
years and older. There are no residential uses for lactofen that

[[Page 57214]]

result in chronic residential exposure to lactofen. In addition, there 
is potential for chronic dietary exposure to lactofen in drinking 
water. After calculating DWLOCs and comparing them to the EECs for 
surface and ground water, EPA does not expect the aggregate exposure to 
exceed 100% of the cPAD, as shown in Table 5 of this unit:

                                    Table 5.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Lactofen
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Surface Water EEC       Ground Water EEC
        Population Subgroup              cPAD mg/kg/day           % cPAD (Food)              (ppb)                  (ppb)           Chronic DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population                      0.08                    <0.1%                   0.008                  0.006                  80
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-50                        0.08                    <0.1%                   0.008                  0.006                  80
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-6                         0.08                    <0.1%                   0.008                  0.006                  80
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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).
    Lactofen is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    4. Aggregate cancer risk for U.S. population. Lactofen is 
considered to be a threshold carcinogen. Because lactofen is considered 
to be unlikely to be carcinogenic at low doses, the chronic exposure 
value is compared with a NOAEL to determine the cancer risk estimate. 
DWLOCs were calculated based on NOAEL of 0.3 mg/kg/day from a special 
7-week rodent study which evaluated peroxisome proliferation in the 
liver of rats and mice. The aggregate cancer risk is presented in Table 
6 of this unit.

                    Table 6.--Aggregate Risk Assessment for Cancer From Exposure to Lactofen
----------------------------------------------------------------------------------------------------------------
                                    Cancer MOE from    Surface Water EEC   Ground Water EEC
       Population Subgroup            food alone             (ppb)               (ppb)        Cancer DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                   300,000             0.005               0.006               105
----------------------------------------------------------------------------------------------------------------

    5. The Agency also conducted an aggregate chronic and cancer risk 
assessment for acifluorfen, derived from the use of the herbicides 
lactofen and sodium acifluorfen, by comparing the total acifluorfen 
surface water and groundwater EECs with the corresponding DWLOCs. As 
indicated in Table 7 of this unit, the EECs for all exposures were less 
than the corresponding DWLOCs; therefore, the Agency has no concern for 
the aggregate risk of the acifluorfen degradate from both lactofen and 
sodium acifluorfen.

                  Table 7.--Aggregate Chronic and Cancer Risk Assessments From Exposure to Total Aciflurofen Degradate From all Sources
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        Surface Water EEC       Surface Water EEC       Ground Water EEC
        Population Subgroup              (ppb) (Chronic)         (ppb) (Cancer)              (ppb)           Chronic DWLOC (ppb)     Cancer DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population                      2.43                    1.34                    3.71                   80                     105
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 lactofen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--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: <a href="/cdn-cgi/l/email-protection#3e4c5b4d575a4b5b535b4a56515a4d7e5b4e5f10595148"><span class="__cf_email__" data-cfemail="eb998e98828f9e8e868e9f83848f98ab8e9b8ac58c849d">[email protected]</span></a>.

B. International Residue Limits

    No maximum residue limits (MRLs) for lactofen have been established 
or proposed by Codex, Canada, or Mexico for any agricultural commodity; 
therefore, no compatibility questions exist with respect to U.S. 
tolerances.

C. Conditions

    The following data must be submitted: Developmental toxicity study 
in rabbits.

V. Conclusion

    Therefore, the tolerance is established for residues of lactofen, 
1-(carboethoxy)ethyl 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-
nitrobenzoate, in or on cotton, undelinted seed at 0.01 ppm; cotton, 
gin byproducts at 0.02 ppm, and peanut at 0.01 ppm.
    In addition, this regulatory action is part of the tolerance 
reassessment requirements of section 408(q) of FFDCA, 21 U.S.C. 
346a(q), as amended by FQPA. By law, EPA is required to reassess all 
tolerances in existence on August 2, 1996 by August 2006. This 
regulatory action will count for two reassessments toward the August 
2006 deadline.

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

[[Page 57215]]

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-2004-0293 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 November 
23, 2004.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (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-2004-0293, 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: <a href="/cdn-cgi/l/email-protection#4f203f3f622b202c242a3b0f2a3f2e61282039"><span class="__cf_email__" data-cfemail="127d62623f767d71797766527762733c757d64">[email protected]</span></a>. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. 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, 
entitled Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This 
final rule does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4). Nor does it require any special 
considerations under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or OMB review or any 
Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a petition under 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,

[[Page 57216]]

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: September 16, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


    2. Section 180.432 is revised to read as follows:


Sec.  180.432  Lactofen; tolerances for residues.

    (a) Tolerances are established for residues of the herbicide 
lactofen, 1-(carboethoxy)ethyl 5-[2-chloro-4-(trifluoromethyl)phenoxy]-
2- nitrobenzoate, in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Beans, snap, succulent (excluding limas)...................         0.01
Cotton, gin byproducts.....................................         0.02
Cotton, undelinted seed....................................         0.01
Peanut.....................................................         0.01
Soybean, seed..............................................         0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 04-21500 Filed 9-23-04; 8:45 am]
BILLING CODE 6560-50-S


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