[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Rules and Regulations]
[Pages 67048-67052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26772]



40 CFR Part 180

[EPA-HQ-OPP-2012-0876; FRL-9400-4]

Prothioconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
prothioconozole in or on bushberries (crop subgroup 13-07B); low 
growing berries, except strawberry (crop subgroup 13-07H); and cucurbit 
vegetables (crop group 9). Bayer CropScience requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 8, 2013. Objections and 
requests for hearings must be received on or before January 7, 2014, 
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-2012-0876, 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 
(RD), 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-2012-0876, 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

[[Page 67049]]

before January 7, 2014. 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-2012-0876, 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.html.

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 December 19, 2012 (77 FR 75082) (FRL-
9372-6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition 2F8044 
by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research 
Triangle Park, NC 27709. The petition requested that 40 CFR 180.626 be 
amended by establishing tolerances for residues of the fungicide 
prothioconazole, (2-(2-(1-chlorocyclpropyl)-3-(2-chlorophenyl)2-
hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione), in or on 
bushberry, subgroup 13-07B at 2.0 ppm; berry, low growing, except 
strawberry subgroup 13-07H at 0.15 ppm; and vegetables, cucurbit, crop 
group 9 at 0.30 parts per million (ppm). That document referenced a 
summary of the petition prepared by Bayer CropScience, 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 
increased the 13-07H berry requested tolerance from 0.15 to 0.20 ppm. 
The reason for this change 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 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 prothioconazole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with prothioconazole 

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 
    Prothioconazole has low acute toxicity by oral, dermal, and 
inhalation routes. It is not a dermal sensitizer, or a skin or eye 
irritant. Prothioconazole's metabolite, prothioconazole-desthio, also 
has low acute toxicity by oral, dermal, and inhalation routes. This 
metabolite is not a dermal sensitizer, or skin irritant, but it is a 
slight eye irritant. The subchronic and chronic studies show that the 
target organs at the lowest observable adverse effects level (LOAEL) 
include the liver, kidney, urinary bladder, thyroid, and blood. In 
addition, the chronic studies showed body weight and food consumption 
changes, and toxicity to the lymphatic and gastrointestinal systems.
    Prothioconazole and its metabolites may be developmental toxicants 
producing effects including malformations in the conceptus at levels 
equal to or below maternally toxic levels in some studies, particularly 
those studies conducted using prothioconazole-desthio. Reproduction 
studies in the rat with prothioconazole and prothioconazole-desthio 
suggest that these chemicals may not be reproductive toxicants.
    The available data show that the prothioconazole-desthio metabolite 
produces toxicity at lower dose levels in subchronic developmental, 
reproductive, and neurotoxicity studies as compared with 
prothioconazole and the two additional metabolites that were tested.
    The available carcinogenicity and/or chronic studies in the mouse 
and rat, using both prothioconazole and prothioconazole-desthio, show 
no increase in tumor incidence. Therefore, EPA has concluded that 
prothioconazole and its metabolites are not carcinogenic, and are 
classified as ``Not likely to be carcinogenic to humans'' according to 
the 2005 Cancer Guidelines.
    Specific information on the studies received and the nature of the 
adverse effects caused by prothioconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies 
can be found at http://www.regulations.gov in document 
``Prothioconazole: Human Health Risk Assessment for Proposed Used on 
Low Growing Berry Subgroup (except Strawberry), Bushberry, Subgroup, 
and Cucurbit Vegetables'' dated June 15, 2013 in docket ID number EPA-

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

[[Page 67050]]

toxicological study to determine the dose at which the NOAEL and the 
lowest dose at which adverse effects of concern are identified. 
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 prothioconazole used 
for human risk assessment is discussed in Unit III. of the final rule 
published in the Federal Register of October 5, 2011 (76 FR 61587) 

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to prothioconazole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing prothioconazole 
tolerances in 40 CFR 180.626. EPA assessed dietary exposures from 
prothioconazole 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 
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
2003-2008, Nationwide Health and Nutrition Examination Survey. As to 
residue levels in food, EPA conducted a moderately refined acute 
dietary exposure assessment. The acute assessment utilized EPA-
recommended tolerance values for all of the proposed uses, average 
field trial residue levels for the existing uses, empirical processing 
factors, and livestock commodity residues derived from feeding studies 
and a balanced dietary burden. The assessment assumed 100 percent crop 
treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008, 
National Health and Nutrition Survey. As to residue levels in food, EPA 
conducted a moderately refined chronic dietary exposure assessment. 
Empirical processing factors, average field trial residues for existing 
uses, EPA-recommended tolerance values for all of the proposed uses, 
and livestock commodity residues derived from feeding studies and a 
reasonably balanced dietary burden were incorporated into the chronic 
assessment which assumed 100 PCT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that prothioconazole is ``Not Likely to be Carcinogenic to 
Humans.'' Therefore a dietary exposure assessment for the purpose of 
assessing cancer risk is unnecessary.
    iv. Anticipated residue. Section 408(b)(2)(E) of FFDCA authorizes 
EPA to use available data and information on the anticipated residue 
levels of pesticide residues in food and the actual levels of pesticide 
residues that have been measured in food. If EPA relies on such 
information, EPA must require pursuant to FFDCA section 408(f)(1) that 
data be provided 5 years after the tolerance is established, modified, 
or left in effect, demonstrating that the levels in food are not above 
the levels anticipated. For the present action, EPA will issue such 
data call-ins as are required by FFDCA section 408(b)(2)(E) and 
authorized under FFDCA section 408(f)(1). Data will be required to be 
submitted no later than 5 years from the date of issuance of these 
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for prothioconazole in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of prothioconazole. 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Tier 1 Rice Model and the Screening 
Concentration in Ground Water (SCI-GROW) models, the estimated drinking 
water concentrations (EDWCs) of prothioconazole for acute exposures are 
estimated to be 99.0 parts per billion (ppb) for surface water and 0.83 
ppb for ground water.
    Chronic exposures for non-cancer assessments are estimated to be 
0.83 ppb for surface water and 91.9 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of 
99.0 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 91.9 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).
    Prothioconazole 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.''
    Prothioconazole is a member of the conazole (triazole) class of 
pesticides. Although conazoles act similarly in plants (fungi) by 
inhibiting ergosterol biosynthesis, there is not necessarily a 
relationship between their pesticidal activity and their mechanism of 
toxicity in mammals. Structural similarities do not constitute a common 
mechanism of toxicity. Evidence is needed to establish that the 
chemicals operate by the same, or essentially the same sequence of 
major biochemical events (EPA, 2002). In conazoles, however, a variable 
pattern of toxicological responses are found; some are heptotoxic and 
hepatocarconogenic in mice. Some induce thyroid tumors in rats. Some 
induce developmental, reproductive, and neurological effects in 
rodents. Furthermore, the conazoles produce a diverse range of 
biochemical events including altered cholesterol levels, stress 
responses, and altered DNA methylation. It is not clearly understood 
whether these biochemical events are directly connected to their 
toxicological outcomes. Thus, there is currently no evidence to 
indicate that conazoles share common mechanism of toxicity. For 
information regarding EPA's procedures for cumulating effects from 
substances found to have a common mechanism of toxicity, see EPA's Web 
site at http//www.epa.gov/pesticides/cumulative.

[[Page 67051]]

    Prothioconazole is a triazole-derived pesticide. Triazole-derived 
pesticides can form the common metabolite, 2,3,4-triazole and three 
triazole conjugates (triazole alanine, triazole acetic acid, and 
triazolylpyruvic acid). To support existing tolerances and to establish 
new tolerances for triazole-derivative pesticides, including 
prothioconazole, EPA conducted a health risk assessment for the 
exposure to 1,2,4-triazole, triazole alanine and triazole acetic acid 
resulting from the use of all current and pending uses of any triazole-
derived fungicide. The risk assessment is a highly conservative, 
screening-level evaluation in terms of hazards associated with common 
metabolites (e.g., use of a maximum combination of uncertainty factors) 
and potential dietary and non-dietary exposures). In addition, the 
Agency retained the additional 10X Food Quality Protection Act (FQPA) 
safety factor (SF) for the protection of infants and children. The 
Agency's prior risk assessment can be found in the propiconazole 
registration docket at http://www.regulations.gov. Updates to assess 
the addition of the commodities included in this rule may be found in 
docket ID number EPA-HQ-OPP-2012-0876 in the document titled ``Common 
Triazole Metabolites: Updated Dietary (Food + Water) Exposure and Risk 
Assessment to Address The New Section 3 Registrations For Use of 
Prothioconazole on Bushberry crop Subgroup 13-07B, Low Growing Berry, 
Except Strawberry, Crop Subgroup 13-07H, and Cucurbit Vegetables Crop 
Group 9; Use of Flutriafol on Coffee; and Ipconazole on Crop Group 6'' 
dated May 12, 2013.

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 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. There is evidence of 
increased susceptibility following prenatal/or postnatal exposure in:
    i. Rat developmental toxicity studies with prothioconazole as well 
as its prothioconozole-desthio and sulfonic acid K salt metabolites.
    ii. Rabbit developmental toxicity studies with prothioconazole-
    iii. A rat developmental neurotoxicity study with prothioconazole-
    iv. Multi-generation reproduction studies in the rat with 
prothioconazole-destio effects, include skeletal structural 
abnormalities, such as cleft palate, deviated snout, malocclusion, 
extra ribs, and developmental delays. Available data also show that the 
skeletal effects such as extra ribs are not completely reversible after 
birth in the rat, but persist as development continues.
    Although increased susceptibility was seen in these studies, the 
Agency concluded there is a low concern and no residual uncertainties 
for prenatal and/or postnatal toxicity effects of prothioconazole 
because: Developmental toxicity NOAELs and LOAELs from prenatal 
exposure are well characterized after oral and dermal exposure; the 
off-spring toxicity NOAELs and LOAELs from postnatal exposures are well 
characterized; and the lowest NOAEL from the developmental studies, the 
NOAEL for the fetal effect malformed vertebral body and ribs in the rat 
dermal developmental study, is used for assessing acute risk of females 
13 years and older.
    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 prothioconazole is considered 
    ii. Evidence of quantitative and qualitative susceptibility of 
offspring were observed in the developmental studies. However, basing 
the POD on the offspring in the most sensitive of these studies 
provides the needed protection of offspring.
    iii. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and EPA-recommended tolerance values for all of the proposed 
uses, average field trial residue levels for the existing uses, 
empirical processing factors, and livestock commodity residues derived 
from feeding studies and a balanced dietary burden. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to prothioconazole 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 prothioconazole.

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.
    Based on the proposed and existing crop uses for prothioconazole, 
dietary aggregate exposures (i.e., food plus drinking water) are 
anticipated. There are no residential uses for prothioconazole and, 
therefore, no residential exposures are anticipated. Consequently, only 
dietary (food plus drinking water) exposures were aggregated for this 
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to prothioconazole will occupy 30% of the aPAD for females, 13-49 years 
of age, 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 
prothioconazole from food and water will utilize 57% of the cPAD for 
all infants (<1 year of age) the population group receiving the 
greatest exposure. There are no residential uses for prothioconazole.
    3. Aggregate cancer risk for U.S. population. Based on lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, prothioconazole is not expected to pose a cancer risk to 
    4. 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 prothioconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies, liquid chromatography methods 
with tandem mass spectrometry detection

[[Page 67052]]

(LC/MS/MS), are 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.
    There are no Canadian, Codex, or Mexican maximum residue limits 
(MRLs) in/on the proposed commodities. Canada will be establishing the 
same tolerances for members of the subject groups or subgroups. 
Therefore, harmonization is not an issue for this petition.

C. Revisions to Petitioned-For Tolerances

    The petitioned-for tolerance for the low growing berry, except 
strawberry, crop subgroup 13-07H was requested at 0.15 ppm. The Agency 
modified the requested 0.15 ppm tolerance to 0.20 ppm which is 
appropriate based on an evaluation of the crop field trial data with 
the Organization of Economic Cooperation and Development (OECD) Maximum 
Residue Level (MRL) Calculation Procedures.

V. Conclusion

    Therefore, tolerances are established for residues of 
prothioconazole, (2-(2-(1-chlorocyclpropyl)-3-(2-chlorophenyl)-2-
hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione), in or on 
bushberry, subgroup 13-07B at 2.0 ppm; berry, low growing, except 
strawberry, subgroup 13-07H at 0.20 ppm; and vegetables, cucurbit, crop 
group 9 at 0.30 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).
    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: October 22, 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.  180.626, add alphabetically the following new entries to 
the table in paragraph (a)(1) to read as follows:

Sec.  180.626  Prothioconazole; tolerances for residues.

    (a)(1) * * *

                                                              Parts per
                         Commodity                             million
                                * * * * *
Berry, low growing, except strawberry, subgroup 13-07H....          0.20
Bushberry, subgroup 13-07B................................          2.0
                                * * * * *
Vegetable, cucurbit, crop group 9.........................          0.30

* * * * *
[FR Doc. 2013-26772 Filed 11-7-13; 8:45 am]