Document ID: EPA-HQ-OPP-2006-0073-0004
Agency: epa
Document Type: Rule
Title: Fomesafen; Pesticide Tolerance
Posted Date: 2006-05-03T14:53:42Z

[Federal Register: May 3, 2006 (Volume 71, Number 85)]
[Rules and Regulations]               
[Page 25945-25951]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my06-12]                         

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0073; FRL-8062-6]

 
Fomesafen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
fomesafen in or on dry bean, snap bean and cotton. Interregional 
Research Project No. 4 (IR-4), and Syngenta Crop Protection 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 May 3, 2006. Objections and 
requests for hearings must be received on or before July 3, 2006.

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 EPA-HQ-

[[Page 25946]]

OPP-2006-0073. All documents in the docket are listed on the 
regulations.gov Web site. (EDOCKET, EPA's electronic public docket and 
comment system was replaced on November 25, 2005, by an enhanced 
federal-wide electronic docket management and comment system located at 
http://www.regulations.gov. Follow the on-line instructions). 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.
     Important Note: OPP will be moving to a new location the 
first week of May 2006. As a result, from Friday, April 28 to Friday, 
May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any 
deliveries at the Crystal Mall 2 address and this facility 
will be closed to the public. Beginning on May 8, 2006, the OPP 
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will 
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S. 
Crystal Drive, Arlington, VA 22202. The mail code for the mailing 
address will change to (7502P), but will otherwise remain the same. The 
OPP Regulatory Public Docket telephone number and hours of operation 
will remain the same after the move.

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: 
miller.joanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

    In addition to using EDOCKET (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 at 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 1, 2006 (71 FR 10508) (FRL-7763-
1), 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 
1E6228, 6E4653, and 1F5068) by Interregional Research Project No. 4 
(IR-4), 681 U. S. Highway No. 1 South, North Brunswick, NJ 08902-3390; 
and Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 
27410. The petitions requested that 40 CFR 180.433 be amended by 
establishing tolerances for residues of the herbicide sodium salt of 
fomesafen, 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-
2-nitrobenzamide, in or on the food commodities dry beans (PP 1E6228), 
snap beans (PP 6E4653), cotton seed and cotton gin byproducts (1F5068) 
at 0.025 parts per million (ppm). That notice included a summary of the 
petition prepared by IR4 and Syngenta Crop Protection, Inc, the 
registrant. There were no comments received in response to the notice 
of filing. EPA has determined that the residue of concern is fomesafen, 
per se. The tolerance expression is revised by removing the phrase 
``sodium salt of''.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish tolerances 
(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 the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

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 fomesafen on bean, 
dry; bean, snap, succulent; cotton, undelinted seed and cotton, gin 
byproducts at 0.025 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the

[[Page 25947]]

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 fomesafen 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.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3050                          28-Day oral         NOAEL = 209
                                   toxicity --         milligrams/
                                   rodents (mouse)     kilogram/day (mg/
                                                       kg/day) for males
                                                       (M) and 247 mg/kg/
                                                       day for females
                                                       (F)
                                                      LOAEL = 917 mg/kg/
                                                       day (M) and 1247
                                                       mg/kg/day (F)
                                                       based on
                                                       decreased body
                                                       weights and body
                                                       weight gains,
                                                       decreased food
                                                       efficiency,
                                                       hematology
                                                       (decreased
                                                       erythrocyte
                                                       count,
                                                       hemoglobin, mean
                                                       corpuscular
                                                       volume, and mean
                                                       corpuscular
                                                       hemoglobin), bile
                                                       duct hyperplasia,
                                                       decreased uterine
                                                       size in females,
                                                       and decreased
                                                       size of the
                                                       seminal vesicles
                                                       in males
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = 0.5 mg/kg/
                                   toxicity --         day
                                   rodents (rat)      LOAEL = 10 mg/kg/
                                                       day based on
                                                       hyalinization of
                                                       hepatocytes,
                                                       increased
                                                       eosinophilia,
                                                       reduced
                                                       granulation,
                                                       increased liver
                                                       weights in males
                                                       and females, and
                                                       increases in
                                                       plasma alkaline
                                                       phosphatase,
                                                       alanine
                                                       transaminase and
                                                       aspartate
                                                       transaminase in
                                                       males
------------------------------------------------------------------------
870.3150                          26-Week oral        NOAEL = 1 mg/kg/
                                   toxicity --         day
                                   nonrodents (dog)   LOAEL = 25 mg/kg/
                                                       day based on
                                                       hematology
                                                       (decreased
                                                       hemoglobin and
                                                       hematocrit
                                                       concentrations
                                                       and erythrocyte
                                                       count and
                                                       increased
                                                       platelet count
                                                       and prothrombin
                                                       time
------------------------------------------------------------------------
870.3200                          21-Day dermal       NOAEL = 1,000 mg/
                                   toxicity (rabbit)   kg/day, Highest
                                                       Dose Tested (HDT)
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental --    100 mg/kg/day
                                   rodents (rat)      Maternal LOAEL =
                                                       200 mg/kg/day
                                                       based on staining
                                                       of the ventral
                                                       fur and
                                                       significantly
                                                       decreased body
                                                       weight gain
                                                       (>10%) .
                                                      Developmental
                                                       NOAEL = 100 mg/kg/
                                                       day
                                                      Developmental
                                                       LOAEL = 200 mg/kg/
                                                       day based on
                                                       postimplantation
                                                       loss
------------------------------------------------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects   NOAEL = 12.5 mg/
                                   (rat)               kg/day
                                                      Parental/Systemic
                                                       LOAEL = 50 mg/kg/
                                                       day based on
                                                       liver
                                                       histopathology in
                                                       males and females
                                                       of both
                                                       generations.
                                                      Reproductive NOAEL
                                                       = 50 mg/kg/day,
                                                       HDTReproductive
                                                       LOAEL = Not
                                                       established
                                                      Offspring NOAEL =
                                                       12.5 mg/kg/day
                                                      Offspring LOAEL =
                                                       50 mg/kg/day
                                                       based on
                                                       increased
                                                       incidence of
                                                       liver
                                                       hyalinization in
                                                       males
------------------------------------------------------------------------
870.4200                          Carcinogenicity-    NOAEL = 1.5 mg/kg/
                                   mice                day
                                                      LOAEL = 15 mg/kg/
                                                       day based on the
                                                       presence of liver
                                                       tumors and liver
                                                       weight increases
                                                       in male and
                                                       female mice
------------------------------------------------------------------------
870.4300                          Chronic toxicity/   NOAEL = 0.25 mg/kg/
                                   Carcinogenicity-    day
                                   rat                LOAEL = 5 mg/kg/
                                                       day based on
                                                       hyalinization of
                                                       the liver in
                                                       males
------------------------------------------------------------------------
870.5100                          Gene mutation -     Negative
                                   bacterial
------------------------------------------------------------------------
870.5300                          Gene mutation -     Negative
                                   mammalian
------------------------------------------------------------------------
870.5375                          Structural          Negative
                                   chromosomal
                                   abberations
------------------------------------------------------------------------
870.5395                          Other genotoxic     Negative
                                   effects
------------------------------------------------------------------------

[[Page 25948]]

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which the NOAEL from the toxicology study 
identified as appropriate for use in risk assessment is used to 
estimate the toxicological level of concern (LOC). However, the 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-\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 fomesafen used for 
human risk assessment is shown in Table 2 of this unit:

      Table 2.--Summary of Toxicological Dose and Endpoints for Fomesafen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,
          Exposure Scenario                Interspecies and     Special FQPA SF and LOC  Study and Toxicological
                                         Intraspecies and any     for Risk Assessment            Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary                           An endpoint of concern for females 13-50 years of age attributable to a
(Females 13-50 years of age).........            single dose was not identified in the hazard database.
----------------------------------------------------------------------------------------------------------------
Acute Dietary                             An endpoint of concern for the general population attributable to a
(General population including infants            single dose was not identified in the hazard database.
 and children).
----------------------------------------------------------------------------------------------------------------
Chronic Dietary                        NOAEL= 0.25 mg/kg/day    Special FQPA SF = 1X     Chronic toxicity - rat
(All populations)....................  UF = 100...............  cPAD =.................  LOAEL = 5 mg/kg/day
                                       Chronic RfD = 0.0025 mg/ chronic RfD /Special      based on hyalinization
                                        kg/day.                  FQPA SF.                 of the liver in males
                                                                = 0.0025 mg/kg/day.....
----------------------------------------------------------------------------------------------------------------
Cancer                                      In accordance with the EPA Final Guidelines for Carcinogen Risk
(oral, dermal, inhalation)...........   Assessment (March 29, 2005), EPA classified fomesafen as ``Not likely to
                                         be carcinogenic to humans''. This decision was based on the weight-of-
                                         evidence which supports activation of peroxisome proliferator-activated
                                            receptor alpha (PPAR) as the mode of action for fomesafen-induced
                                              hepatocarcinogenesis in mice. The data did not support either
                                          mutagenesis or cytotoxicity followed by regenerative proliferation as
                                        alternative modes of action. While the proposed mode of action for liver
                                               tumors in mice is theoretically plausible in humans, it is
                                        quantitatively implausible and unlikely to take place in humans based on
                                         quantitative species differences in PPAR activation and toxicokinetics.
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.433) for the residues of sodium salt of 
fomesafen, in or on soybeans. Risk assessments were conducted by EPA to 
assess dietary exposures from fomesafen 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

[[Page 25949]]

occurring as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
fomesafen; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: For the chronic analyses, tolerance-level residues were 
assumed for all food commodities with current or proposed fomesafen 
tolerances, and it was assumed that all of the crops included in the 
analysis were treated. Percent Crop Treated (PCT) and/or anticipated 
residues were not used in the chronic risk assessment.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for fomesafen 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 fomesafen.
    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 incorporates 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 
LOC.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency uses 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 pecent Reference dose 
(%RfD) or percent population adjusted dose (%PAD).
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of fomesafen 
for chronic exposures are estimated to be 10.535 parts per billion 
(ppb) for surface water and 1.0 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).
    Fomesafen 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 the 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 fomesafen and any other 
substances and fomesafen does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that fomesafen 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 Office of Pesticide Programs 
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 database 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 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no concern and/or 
residual uncertainty with regard to prenatal and/or postnatal increased 
susceptibility. The requirement for an acceptable ``guideline'' 
developmental toxicity study in a second species has not been 
satisfied. The study in rabbits is deficient. Individual animal data 
were not reported and all fetuses were not examined for both soft 
tissue and skeletal alterations; and historical control data were not 
provided. Additionally, animals had an intercurrent infection that 
confounded interpretation of the results of the study. Therefore, the 
developmental toxicity study in the rabbit was classified 
``Unacceptable/Guideline''. However, a new developmental toxicity study 
in rabbits is not required at this time because sufficient numbers of 
fetuses were available for examination in the rabbit developmental 
toxicity study. There was no increase in fetal deaths at the highest 
dose tested even though the dams suffered with an intercurrent 
infection. There were no external or internal malformation/
abnormalities, soft tissue or skeletal that could be related to 
treatment with the test material at any of the three dosage levels 
tested including the highest dose level of 40 mg/kg/day. The study does 
not meet current guideline standards, but it does provide sufficient 
information on the possible effects the test material

[[Page 25950]]

might have on the developing rabbit fetus, especially since the 
maternal animals were additionally under considerable stress from 
infection.
    3. Conclusion. The fomesafen toxicity database is adequate for the 
risk assessment since we are not asking for a repeat developmental 
toxicity study in rabbits at this time. In addition, there is no 
evidence of increased susceptibility, no residual uncertainty in the 
database, and exposure data are complete or are estimated based on 
that, reasonably account for potential exposures. Accordingly, the 
additional 10X factor for the protection of infants and children is 
removed.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An endpoint of concern attributable to a single dose 
exposure to fomesafen was not identified in the hazard database. 
Therefore there are no acute toxicological concerns for fomesafen.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to fomesafen 
from food and drinking water will utilize 9.5% of the cPAD for the U.S. 
population, 31% of the cPAD for all infants (<  1 year old), and 15% of 
the cPAD for children 1-2 years old. Fomesafen 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 LOC.
    3. 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 fomesafen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (chemical derivatization followed 
by gas chromatography with Nitrogen-Phosphorus detection) 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: residuemethods@epa.gov.

B. International Residue Limits

    No Codex Maximum residue levels (MRLs) have been established for 
residues of fomesafen. Canadian MRLs have been established for residues 
of fomesafen in or on dry beans; lima beans; snap beans; and soybeans 
at 0.05 ppm, and a Mexican MRL of 0.05 mg/kg has been established for 
residues of fomesafen in or on soybeans. Syngenta Canada will be 
submitting a request to lower the fomesafen MRLs in Canada to match 
those being proposed for the USA. Therefore the MRLs will eventually be 
harmonized.

V. Conclusion

    Therefore, the tolerance is established for residues of fomesafen, 
5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-
nitrobenzamide, in or on bean, dry; bean, snap, succulent; cotton, 
undelinted seed and cotton, gin byproducts at 0.025 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 EPA-HQ-OPP-2006-0073 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 July 3, 
2006.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A.1., 
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 EPA-HQ-OPP-2006-0073, to: 
Public Information and Records Integrity Branch, Information Technology 
and Resources Management 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.

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

[[Page 25951]]

Budget (OMB) has exempted these types of actions from review under 
Executive Order 12866, entitled Regulatory Planning and Review (58 FR 
51735, October 4, 1993). Because this rule has been exempted from 
review under Executive Order 12866 due to its lack of significance, 
this rule is not subject to Executive Order 13211, Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires 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: April 27, 2006.
Lois Rossi,
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 180.433 is revised to read as follows:

Sec.  180.433   Fomesafen; tolerances for residues.

    (a) General. Tolerances are established for the residues of 
fomesafen 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-
nitrobenzamide from the application of its sodium salt in or on the 
following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Bean, dry..................................................        0.025
Bean, snap, succulent......................................        0.025
Cotton, gin byproducts.....................................        0.025
Cotton, undelinted seed....................................        0.025
Soybean....................................................         0.05
------------------------------------------------------------------------

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

[FR Doc. 06-4160 Filed 5-2-06; 8:45 am]

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