Document ID: EPA-HQ-OPP-2010-0122-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fomesafen
Posted Date: 2011-03-09T05:00Z

[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Rules and Regulations]
[Pages 12877-12882]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5070]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0122; FRL-8858-5]

Fomesafen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fomesafen in or on pepper (bell and non-bell), potato, and tomato. 
Syngenta Crop Protection, Inc. requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 9, 2011. Objections and 
requests for hearings must be received on or before May 9, 2011, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0122. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., 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 in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: stanton.susan@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 those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide 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 get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2010-0122 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
May 9, 2011. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0122, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-for Tolerance

    In the Federal Registers of September 4, 2009 (74 FR 45848) (FRL-
8434-4) and March 19, 2010 (75 FR 13277) (FRL-8813-2), EPA issued 
notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide petitions (PP 9F7563 and PP 9F7667) 
by Syngenta Crop Protection, Inc., PO Box 18300, Greensboro, NC 27419-
8300. The petitions requested that 40 CFR 180.433

[[Page 12878]]

be amended by establishing tolerances for residues of the herbicide 
fomesafen, 5-[2-cloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-
nitrobenzamide, in or on potato and tomato (PP 9F7563); and pepper (PP 
9F7667) at 0.025 parts per million (ppm). Those notices referenced 
summaries of the petitions prepared by Syngenta Crop Protection, Inc., 
the registrant, which are available in the dockets, http://www.regulations.gov. There were no comments received in response to the 
notice of filing of PP 9F7563. Comments were received on the notice of 
filing of PP 9F7667. EPA's response to these comments is discussed in 
Unit IV.C.
    EPA has revised the proposed tolerance expression and the commodity 
terms for peppers in accordance with current Agency policy. These 
revisions are discussed in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    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. * * 
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in 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 for fomesafen including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with fomesafen 
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.
    Fomesafen has a low order of acute toxicity by the oral route of 
exposure, is severely irritating to the eye, and is moderately 
irritating to the skin. In the subchronic and chronic toxicity studies 
in rats and mice, food consumption or food efficiency, body weight/body 
weight gain, and histopathological changes in the liver were the 
parameters that were most often affected. Dogs and mice also showed 
hematological changes (e.g., decreased erythrocyte count, hemoglobin, 
or hematocrit). There was no evidence of neurotoxicity or 
immunotoxicity in the toxicological studies with fomesafen. There was 
no evidence that fomesafen results in increased susceptibility of rat 
or rabbit fetuses in the prenatal developmental studies or in young 
rats in the 2-generation reproduction study.
    There was no evidence of carcinogenicity in the rat chronic 
toxicity/carcinogenicity study. Liver tumors were produced in the mouse 
carcinogenicity study; however, EPA classified fomesafen as ``Not 
Likely to be Carcinogenic to Humans,'' based on the weight-of-evidence 
supporting activation of peroxisome proliferator-activated receptor 
alpha (PPAR[alpha]) 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 
unlikely to take place in humans based on quantitative species 
differences in PPAR[alpha] activation and toxicokinetics. Detailed 
information on the factors EPA considered in making this determination 
can be found at http://www.regulations.gov in the document ``FOMESAFEN: 
Second Report of the Cancer Assessment Review Committee'' in docket ID 
number EPA-HQ-OPP-2010-0122.
    Specific information on the studies received and the nature of the 
adverse effects caused by fomesafen as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Fomesafen Sodium: Human Health 
Risk Assessment for the Establishment of Tolerances and Registration of 
New Uses of Fomesafen Sodium on Potatoes and Peppers,'' p. 30 in docket 
ID number EPA-HQ-OPP-2010-0122.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fomesafen used for 
human risk assessment is shown the Table of this unit.

[[Page 12879]]

    Table--Summary of Toxicological Doses and Endpoints for Fomesafen for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
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Acute dietary (All population          No toxic effects attributable to a single dose of fomesafen were found in
 subgroups, including Females 13-49                                   the database.
 years of age, infants and children).
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Chronic dietary (All populations)....  NOAEL= 0.25 mg/kg/day    Chronic RfD = 0.0025 mg/ Chronic toxicity--rat
                                        UFA = 10x.               kg/day.                  LOAEL = 5 mg/kg/day
                                       UFH = 10x FQPA SF = 1x.                            based on hyalinization
                                                                                          of the liver in males.
                                                                cPAD = 0.0025 mg/kg/
                                                                 day.
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....   Fomesafen is classified as ``Not Likely to be Carcinogenic to Humans.''
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UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fomesafen, EPA considered exposure under the petitioned-for 
tolerances as well as all existing fomesafen tolerances in 40 CFR 
180.433. EPA assessed 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 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 food consumption data from the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intakes by Individuals (CSFII). As to 
residue levels in food, EPA assumed that residues would be present in 
all commodities at the tolerance level and that 100% of all crops are 
treated with fomesafen. Dietary Exposure Evaluation Model/Food 
Commodity Intake Database (DEEM-FCID\TM\), Version 2.03, default 
processing factors were used to determine residues in processed 
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fomesafen does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for fomesafen. Tolerance level residues and 100 PCT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used a 
screening-level water exposure model to estimate residues of fomesafen 
in surface water. This simulation model, the Pesticide Root Zone Model/
Exposure Analysis Modeling System (PRZM/EXAMS), takes into account data 
on the physical, chemical, and fate/transport characteristics of 
fomesafen. Further information regarding EPA drinking water models used 
in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the model results, the estimated drinking water 
concentration (EDWC) of fomesafen for chronic exposures for non-cancer 
assessments is estimated to be 10.535 parts per billion (ppb) for 
surface water.
    The Agency estimated residues of fomesafen in ground water based on 
the results of a prospective ground water monitoring study, submitted 
by the registrant, Syngenta Crop Protection, Inc. The maximum residue 
found in the study, which was conducted on a vulnerable North Carolina 
soil using a soybean cropping system, was 1 ppb, an order of magnitude 
lower than the modeled estimate for surface water.
    The modeled estimate of fomesafen in surface water was used in the 
dietary exposure analysis and risk assessment for fomesafen in drinking 
water. For chronic dietary risk assessment, the water concentration of 
value 10.535 ppb was directly entered into the dietary exposure model 
to assess the contribution to drinking 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 any specific use patterns 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.''
    Fomesafen is a member of the diphenyl ether chemical family. The 
common toxicity that these compounds share is induction of liver 
effects (liver hypertrophy, increase in liver weight, tumors). Members 
of this class have been shown to induce rodent liver effects/tumors 
through the activation of the peroxisome proliferator-activated 
receptor (PPAR[alpha]). It should be noted that liver hypertrophy and 
increases in liver weight are part of the range of morphological 
changes that result from chemically-mediated effects on the PPAR[alpha] 
receptor and hepatocarcinogenesis. Although PPAR[alpha] agonists can 
induce liver rodent tumors, the potential for PPAR[alpha] agonists to 
induce liver tumors in other species, including humans, appears to be 
unlikely. This is because evidence shows that these other species are 
quantitatively less sensitive to the effects of PPAR[alpha] agonism due 
to toxicodynamic differences between the human and rodent nuclear 
PPAR[alpha] receptor. Thus, while this mode of action for liver tumors 
in rodent is

[[Page 12880]]

qualitatively possible in humans, it is unlikely to take place in 
humans based on quantitative species differences in PPAR[alpha] 
activation and toxicokinetics. Accordingly, although members of the 
diphenyl ether family, as well as other classes of compounds, may share 
a common hepatocarcinogenic mode of action, cumulative exposure to 
PPAR[alpha] agonists is unlikely to induce liver carcinogenesis in 
humans.
    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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The pre- and postnatal 
database for fomesafen includes a prenatal developmental toxicity study 
in rabbits, two prenatal developmental toxicity studies in rats, and a 
2-generation reproduction toxicity study in rats. The rabbit 
developmental study was classified as unacceptable because of bacterial 
infection in the colony; however, the study provided information to 
assess potential developmental toxicity in rabbits. There was no 
significant difference between the treated and control animals for 
developmental abnormalities in the rabbit study. In the two rat 
developmental studies (considered together), developmental effects 
(postimplantation loss) occurred at the same dose causing maternal 
toxicity (staining of the ventral fur and significantly decreased body 
weight gain (>10%)). In the rat reproduction study, offspring effects 
(increased incidence of liver hyalinization in males) occurred at the 
same dose causing parental effects (liver histopathology in males and 
females of both generations).
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for fomesafen is largely complete, lacking 
only immunotoxicity and acute and subchronic neurotoxicity studies. EPA 
has evaluated the available toxicity data for fomesafen and determined 
that an additional database uncertainty factor is not needed to account 
for the lack of these studies. As stated in Unit III.A, fomesafen 
primarily impacts the parameters of food consumption or food 
efficiency, body weight/body weight gain, and histopathological changes 
in the liver. There is no evidence that fomesafen causes immunotoxic or 
neurotoxic effects in any of the available toxicity studies, and EPA 
does not believe that conducting immunotoxicity and acute/subchronic 
neurotoxicity testing will result in a NOAEL less than 0.25 mg/kg/day, 
which is presently used as the point of departure for chronic risk 
assessment.
    ii. There is no indication that fomesafen is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that fomesafen results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the surface water modeling used to assess 
exposure to fomesafen in drinking water. These assessments will not 
underestimate the exposure and risks posed by fomesafen.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
fomesafen is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fomesafen from food and water will utilize 32% of the cPAD for infants, 
less than 1 year old, the population group receiving the greatest 
exposure. There are no residential uses for fomesafen.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- or intermediate-term 
residential exposure plus chronic exposure from food and water 
(considered to be a background exposure level). Short-/intermediate-
term adverse effects (hyalinization of hepatocytes, increased 
eosinophilia, reduced granulation, increased liver weights in males and 
females, and increases in plasma alkaline phosphatase, alanine 
transminase and aspartate transaminase in males in the 90-day rat 
feeding study) were identified; however, fomesafen is not registered 
for any use patterns that would result in short- or intermediate-term 
residential exposure. Short- and intermediate-term risks are assessed 
based on short- or intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no short- or intermediate-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess short-term risk), no further 
assessment of short- or intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating short- and 
intermediate-term risk for fomesafen.
    4. Aggregate cancer risk for U.S. population. As explained in Unit 
III.A, EPA has concluded that the mode of action for fomesafen-induced 
hepatocarcinogenesis in mice is unlikely to take place in humans; 
therefore, fomesafen is not expected to pose a cancer risk to humans.
    5. 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, or to infants and children from aggregate 
exposure to fomesafen residues.

[[Page 12881]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography with tandem mass spectrometry detection (HPLC/MS/MS)) 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

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established a MRL for fomesafen on pepper, potato, or tomato.

C. Response to Comments

    An anonymous citizen objected to the presence of any pesticide 
residues on food. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that pesticides should be 
banned completely. However, the existing legal framework provided by 
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) 
contemplates that tolerances greater than zero may be set when persons 
seeking such tolerances or exemptions have demonstrated that the 
pesticide meets the safety standard imposed by that statute. This 
citizen's comment appears to be directed at the underlying statute and 
not EPA's implementation of it; the citizen has made no contention that 
EPA has acted in violation of the statutory framework.

D. Revisions to Petitioned-for Tolerances

    In its petition PP 9F7667, the registrant proposed a tolerance of 
0.025 ppm for residues of fomesafen in or on the commodity ``pepper.'' 
Consistent with recommendations in the Agency's Food and Feed Commodity 
Vocabulary, EPA is establishing separate tolerances for ``pepper, 
bell'' and ``pepper, non-bell'' at 0.025 ppm each.
    EPA is also revising the requested tolerance expression to clarify 
the chemical moieties that are covered by the tolerances and specify 
how compliance with the tolerances is to be measured. The revised 
tolerance expression makes clear that the tolerances cover residues of 
the herbicide fomesafen, including its metabolites and degradates, but 
that compliance with the tolerance levels is to be determined by 
measuring only fomesafen, 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-
(methylsulfonyl)-2-nitrobenzamide.

V. Conclusion

    Therefore, tolerances are established for residues of fomesafen, 
including its metabolites and degradates, in or on pepper, bell; 
pepper, non-bell; potato; and tomato at 0.025 ppm. Compliance with the 
tolerance levels is to be determined by measuring only fomesafen, 5-[2-
chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-nitrobenzamide.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been 
exempted from review under Executive Order 12866, this final 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) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). 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., 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).
    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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal governments, on the relationship between the national government 
and the States or Tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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.

[[Page 12882]]

    Dated: February 28, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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 amended by revising the introductory text in 
paragraph (a) and alphabetically adding the following commodities to 
the table in paragraph (a) to read as follows:

Sec.  180.433  Fomesafen; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide fomesafen, including its metabolites and degradates, in or on 
the following commodities. Compliance with the tolerance levels 
specified in the following table below is to be determined by measuring 
only fomesafen, 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-
(methylsulfonyl)-2-nitrobenzamide, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                 * * * *
Pepper, bell................................................       0.025
Pepper, non-bell............................................       0.025
Potato......................................................       0.025
 
                                 * * * *
Tomato......................................................       0.025
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-5070 Filed 3-8-11; 8:45 am]
BILLING CODE 6560-50-P