[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Rules and Regulations]
[Pages 44440-44444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17823]

[[Page 44440]]



40 CFR Part 180

[EPA-HQ-OPP-2012-0419; FRL-9390-2]

Imazosulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
imazosulfuron in or on the melon subgroup 9A and the tuberous and corm 
subgroup 1C. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 

DATES: This regulation is effective July 24, 2013. Objections and 
requests for hearings must be received on or before September 23, 2013, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0419, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: [email protected].


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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2012-0419 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 
September 23, 2013. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0419, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 22, 2012 (77 FR 50661) (FRL-9358-
9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2E8025) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201W., Princeton, NJ 08540. The petition requested 
that 40 CFR 180.651 be amended by establishing tolerances for residues 
of the herbicide imazosulfuron, (2-chloro-N-[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl] imidazo-[1,2-a]pyridine-3-sulfonamide), in 
or on tuberous and corm vegetables, crop subgroup 1C at 0.02 parts per 
million (ppm); and in melon, crop subgroup 9A at 0.02 ppm. That 
document referenced a summary of the petition prepared by Valent USA 
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the commodity definitions to be consistent with Agency policy. 
The reason for these changes is explained in Unit IV.C.

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

[[Page 44441]]

reasonable certainty that no harm will result to infants and children 
from aggregate exposure to the pesticide chemical residue.* * *''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for imazosulfuron including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with imazosulfuron 

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 
    The toxicology data for imazosulfuron suggest that this herbicide 
possesses relatively low toxicity. Many of the effects of single or 
repeated dosing were observed near or beyond the respective limit 
    The primary target organ of imazosulfuron in repeated-dose studies 
was the liver in all species tested. Mild to moderate thyroid effects 
were apparent only in the chronic toxicity study in dogs. Dramatic eye 
effects (retinal degeneration, lens vascularization, cataracts and 
corneal scarring) were observed in rats fed >1,000 mg/kg/day beginning 
at 3 months in the chronic toxicity/carcinogenicity study. Ocular 
effects (increased incidence of eye opacity, corneal edema, 
inflammation and neovascularization) were also observed in the high-
dose males (4,577 mg/kg/day) in the 90-day feeding toxicity study in 
rats. Decreased body weight and body weight gain compared to control 
were frequent findings throughout the toxicology database for 
    Clinical signs (decreased motor activity, abnormal gait, upward 
curvature of the spine and piloerection) were observed in males at the 
limit dose of the acute neurotoxicity study; however, these effects can 
be attributed to generalized toxicity and were resolved by day 2 of the 
study. No neurotoxic effects were observed during the subchronic 
screening battery or noted as clinical signs in any other repeated-dose 
    No developmental effects were observed at the highest dose tested 
(HDT) (125 mg/kg/day) in the rabbit developmental toxicity study. No 
developmental or reproductive toxicity was observed in the 1-generation 
rat study. Decreased pup viability was observed in the rat 2-generation 
reproduction study at a dose approaching the limit dose (LOAEL = 892 
mg/kg/day) in both the F1 and F2 offspring generations. Mortality was 
also observed in the parental generation at this dose. No increased 
qualitative or quantitative offspring susceptibility was apparent in 
any of the submitted studies for imazosulfuron.
    There was no evidence of carcinogenicity in rats and mice up to the 
limit dose at 24 and 18 months, respectively. Imazosulfuron was 
determined to be non-mutagenic in bacteria and negative in an in vivo 
mammalian cytogenetics assay. Overall, there was no evidence that 
imazosulfuron was either mutagenic or clastogenic in either in vivo or 
in vitro assays. The cancer classification is ``not likely to be 
carcinogenic to humans,'' based on the absence of significant tumor 
increases in the carcinogenicity studies.
    Specific information on the studies received and the nature of the 
adverse effects caused by imazosulfuron 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 titled ``Imazosulfuron: Human 
Health Risk Assessment for Proposed Uses on Melon (Crop Subgroup 9A) 
and Tuberous and Corm Vegetables (Crop Subgroup 1C),'' pp. 29-33 in 
docket ID number EPA-HQ-OPP-2012-0419.

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 imazosulfuron used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of December 29, 2010 (75 FR 81878) 

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to imazosulfuron, EPA considered exposure under the 
petitioned-for tolerances as well as all existing imazosulfuron 
tolerances in 40 CFR 180.651. EPA assessed dietary exposures from 
imazosulfuron 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.
    Such effects were identified for imazosulfuron. In estimating acute 
dietary exposure, EPA used food consumption information from the U.S. 
Department of Agriculture (USDA) 2003-2008 National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, EPA assumed 100 percent crop treated (PCT) 
and tolerance-level residues for all registered and proposed uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and 
tolerance-level residues for all registered and proposed uses.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that imazosulfuron 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 PCT information. EPA did not use 
anticipated residue and/or PCT

[[Page 44442]]

information in the dietary assessment for imazosulfuron. Tolerance 
level residues and/or 100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for imazosulfuron in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of imazosulfuron. 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 Tier 1 Rice Model and Screening Concentration in 
Ground Water (SCI-GROW) models, the estimated drinking water 
concentrations (EDWCs) of imazosulfuron for acute exposures are 
estimated to be 278.9 parts per billion (ppb) for surface water and 4.8 
ppb for ground water and for chronic exposures are estimated to be 
278.9 ppb for surface water and 4.8 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 278.9 ppb was used to 
assess the contribution to drinking water. For the chronic dietary risk 
assessment, the water concentration of value 278.9 ppb was used 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). Imazosulfuron is 
currently registered for the following uses that could result in 
residential exposures: Residential turfgrass and recreational areas. 
EPA assessed residential exposure using the following assumptions:
    Residential handlers may receive short-term dermal and inhalation 
exposure to imazosulfuron when mixing, loading, and applying the 
pesticide on home lawns. Since a dermal endpoint of concern was not 
identified for imazosulfuron, only short-term inhalation exposure of 
residential handlers was assessed.
    Post-application inhalation exposure is not expected due to the 
nature of pesticide applications to residential lawns. Based on climate 
effects (such as rain) and post-application activities (such as lawn 
mowing), inhalation exposure to imazosulfuron is expected to be 
negligible. Furthermore, imazosulfuron has low acute inhalation 
toxicity, low vapor pressure (<3.5 x 10-6 Pa) and a low 
proposed use rate (0.3 lb ai/A). Therefore, EPA assessed only short-
term post-application incidental oral exposure of children (toddlers) 
based on the following scenarios: Incidental oral exposure from treated 
turf via hand-to-mouth activities; incidental oral exposure from 
treated turf via object-to-mouth activities; and incidental oral 
exposure from treated turf via soil ingestion.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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.''
    EPA has not found imazosulfuron to share a common mechanism of 
toxicity with any other substances, and imazosulfuron does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
imazosulfuron does not have 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 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 
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility following in utero and/or postnatal exposure 
in the developmental toxicity studies in rats or rabbits, or in the 2-
generation rat reproduction study. Neither the rat nor rabbit 
developmental studies identified developmental effects. The parental 
NOAEL is clearly defined, less than or equal to the offspring NOAEL and 
based on general systemic toxicity. At near-limit dose, 20%-30% 
decreases in numbers of implants/dam, total pups/dam and live pups/dam 
on post-natal day (PND) 0, and viability index were observed in 
F1 pups of the 2-generation reproductive study in rats. 
Similarly, decreased live pups/dam and live births and viability and 
lactation indices were noted for F2 pups at doses that 
induced parental mortality. The points of departure are protective of 
these effects.
    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 
    i. The toxicity database for imazosulfuron is complete.
    ii. There is no indication that imazosulfuron is a neurotoxic 
chemical based on clinical observations of neurotoxicity during the 
conduct of developmental or chronic studies. No adverse neurobehavioral 
signs were observed at doses approaching the limit dose in any of the 
short-term studies (subchronic oral, 21-day dermal). No neurotoxic 
effects were observed during the subchronic neurotoxicity screen in 
which adverse effects of decreased body weight, body weight gain and 
food efficiency were observed at 575 mg/kg/day (LOAEL). The acute 
neurotoxicity screen (ACN) yielded a LOAEL at the limit dose for 
clinical signs, abnormal gait, decreased activity, piloerection and 
upward curvature of the spine and decreased motor activity in males, 
all of which were resolved by day 2. No treatment-related effects were 
observed in Functional Observational Battery (FOB) parameters, gross 
and neurohistopathology, motor activity or brain morphometrics of the 
ACN. The weight of evidence demonstrates that imazosulfuron is not a 
neurotoxic compound because the clinical findings in the ACN study 
occurred only at the limit dose and may be attributed to generalized 
toxicity. A developmental neurotoxicity study is not required at this 
    iii. As discussed in Unit III.D.2., there is no concern for 
increased susceptibility to offspring following pre- and postnatal 
exposure to rats or in utero exposure in rabbits.
    iv. There are no residual uncertainties identified in the exposure 

[[Page 44443]]

The dietary food exposure assessments were performed based on 100 PCT 
and tolerance-level residues. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to imazosulfuron in drinking water. EPA used similarly 
conservative assumptions to assess postapplication exposure of children 
as well as incidental oral exposure of toddlers. These assessments will 
not underestimate the exposure and risks posed by imazosulfuron.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to imazosulfuron will occupy 1.2% of the aPAD for all infants less than 
one year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
imazosulfuron from food and water will utilize 2% of the cPAD for all 
infants less than one year old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
imazosulfuron is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Imazosulfuron is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to imazosulfuron.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 33,000 for adults 
and 8,700 for children. Because EPA's level of concern for 
imazosulfuron is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
    An intermediate-term adverse effect was identified; however, 
imazosulfuron is not registered for any use patterns that would result 
in intermediate-term residential exposure. Because there is no 
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 intermediate-term 
risk), no further assessment of intermediate-term risk is necessary, 
and EPA relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for imazosulfuron.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, imazosulfuron is not expected to pose a cancer risk to humans.
    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 or to infants and children from aggregate 
exposure to imazosulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography method with tandem mass spectroscopy detection (LC/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; email address: 
[email protected].

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 United Nations 
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 any MRLs for imazosulfuron.

C. Revisions to Petitioned-For Tolerances

    The proposed commodity definitions are being modified from ``Melon 
crop subgroup 9A'' to ``Melon subgroup 9A'' and ``Tuberous and corm 
vegetables crop subgroup 1C'' to ``Vegetable, tuberous and corm, 
subgroup 1C'' to be in line with Agency terminology.

V. Conclusion

    Therefore, tolerances are established for residues of 
imazosulfuron, (2-chloro-N-[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl] imidazo-[1,2-a]pyridine-3-sulfonamide), in 
or on melon subgroup 9A at 0.02 ppm and vegetable, tuberous and corm, 
subgroup 1C at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this 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).

[[Page 44444]]

    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: July 17, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.651, in paragraph (a), add alphabetically the following 
commodities to the table to read as follows:

Sec.  180.651  Imazosulfuron; tolerances for residues.

    (a) * * *

                                                               Parts per
                          Commodity                             million
Melon subgroup 9A............................................       0.02
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C....................       0.02

* * * * *
[FR Doc. 2013-17823 Filed 7-23-13; 8:45 am]