Document ID: EPA-HQ-OPP-2014-0340-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Trinexapac-ethyl
Posted Date: 2015-05-20T04:00Z

[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Rules and Regulations]
[Pages 28843-28848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11972]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0340; FRL-9926-62]

Trinexapac-ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
trinexapac-ethyl in or on multiple commodities which are identified and 
discussed later in this document. Syngenta Crop protection LLC 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective May 20, 2015. Objections and 
requests for hearings must be received on or before July 20, 2015, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also

[[Page 28844]]

Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0340, 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), West William Jefferson Clinton 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
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 
Publishing 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-2014-0340 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 
July 20, 2015. 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-2014-0340, 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 
20460-0001.
     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 August 1, 2014 (79 FR 44731) (FRL-9911-
67), 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 
4F8254) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419. The petition requested that 40 CFR 180.662 be amended by 
establishing tolerances for residues of the plant growth regulator 
trinexapac-ethyl, (4-(cyclopropyl-a-hydroxy-methylene)-3,5-dioxo-
cyclohexanecarboxylic acid ethyl ester), and its primary metabolite 
CGA-179500 in or on rice, bran at 1.5 parts per million (ppm); rice, 
grain at 0.4 ppm; rice, straw at 0.07 ppm; rice, wild, grain at 0.4 
ppm; rye, bran at 2.5 ppm; rye, grain at 2.0 ppm; rye, hay at 0.8 ppm; 
and rye, straw at 0.4 ppm. That document referenced a summary of the 
petition prepared by Syngenta Crop Protection LLC, 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 proposed tolerances on rye commodities to rye, bran at 6.0 
ppm; rye, grain at 4.0 ppm; rye, hay at 1.5 ppm; and rye, straw at 0.9 
ppm. The reason for these changes are 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 trinexapac-ethyl including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with trinexapac-
ethyl follows.

A. Toxicological Profile

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

[[Page 28845]]

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.
    Trinexapac-ethyl exhibits low acute toxicity as shown in the 
standard acute toxicity battery as well as in the acute neurotoxicity 
study in rats with no systemic or neurotoxic effects up to the limit 
dose. The dog appears to be the most sensitive species while no 
systemic adverse effects were seen in rats, rabbits, or mice up to the 
limit dose (1,000 milligram/kilogram/day (mg/kg/day)) following 
subchronic or chronic oral exposure. In the dogs; however, decreased 
body weight gain and food consumption, diffuse thymic atrophy, and 
changes in the epithelial cells of the renal tubules were seen in the 
90-day dog study at 516/582 mg/kg/day (males/females). Following 
chronic exposure, dose-related neuropathology of the brain 
characterized as focal bilateral vacuolation of the dorsal medial 
hippocampus and/or lateral midbrain was seen at >=365/357 mg/kg/day in 
male and female dogs, respectively. The lesions remained confined to 
the supporting cells in the central nervous system and did not progress 
to more advanced or more extensive damage of the nervous tissue. These 
lesions were not associated with other neuropathological findings or 
overt neurological signs, so their biological significance is unknown. 
Similar lesions were not observed in the rat or mouse following 
subchronic or chronic dietary exposure, and there was no other evidence 
in any other species tested to indicate a neurotoxicity potential. 
Furthermore, the brain lesions observed in the chronic dog study are 
not likely to develop from a short-term exposure and were not observed 
in either the rat or mouse short-term studies. In support of these 
findings, no evidence of neurotoxicity in the acute or subchronic rat 
neurotoxicity studies was found.
    In the rat and rabbit developmental toxicity studies, there is 
evidence of increased qualitative and quantitative susceptibility in 
the rat (increased incidence of asymmetrical sternebrae at the limit 
dose) and rabbit (decreased number of live fetuses/litter and increased 
post-implantation loss and early resorption at 360 mg/kg/day) in the 
absence of maternal toxicity. Qualitative sensitivity was observed in 
the 2-generation reproduction study but only in excess of the limit 
dose (1,212 mg/kg/day). The decreased pup survival when analyzed with 
sexes combined, resulted in statistical significance (5-7%); this 
finding was not significant when the data were analyzed separately. 
Further evaluation of the individual litters suggested that one or two 
litters were the cause of the reduced pup survival at the highest dose 
tested. Reproductive toxicity was not observed up to the limit dose. 
There was also no indication of immunotoxicity in mice up to the limit 
dose.
    Data from the combined chronic toxicity/carcinogenicity study in 
the rat did not demonstrate an increase in any tumor type that would be 
relevant to humans. The observation of squamous cell carcinomas in the 
non-glandular portion of the stomach of two males at 806 mg/kg/day does 
not provide reasonable evidence of a possible deleterious effect of 
trinexapac-ethyl on the pharynx and/or esophagus (non-glandular areas) 
of the human. This is because trinexapac-ethyl would not be in contact 
with human tissues for a significant period of time compared to the 
length of time it was in contact with the non-glandular portion of the 
rat stomach. Follicular adenocarcinomas of the thyroid were 
significantly increased in males (5%) at 806 mg/kg/day but this value 
was within the historical control range. In the mouse, there was no 
evidence of carcinogenicity. The mutagenicity database is complete, 
with no evidence of mutagenicity. The cancer classification for 
trinexapac-ethyl is ``Not Likely to be Carcinogenic to Humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by trinexapac-ethyl 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 document ``Trinexapac-ethyl: Human Health Risk 
Assessment to Support New Uses on Rice and Rye'' on page 34 in docket 
ID number EPA-HQ-OPP-2014-0340.

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 trinexapac-ethyl used 
for human risk assessment is discussed in Unit III B. of the final rule 
published in the Federal Register of March 2, 2012 (77 FR 12742) (FRL-
9337-9).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to trinexapac-ethyl, EPA considered exposure under the 
petitioned-for tolerances (as revised in this regulation) as well as 
all existing trinexapac-ethyl tolerances in 40 CFR 180.662. EPA 
assessed dietary exposures from trinexapac-ethyl 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 trinexapac-ethyl. In estimating acute dietary exposure, EPA used 
food consumption information from the United States 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 that residues are present in all commodities at the 
tolerance level and that 100% of all commodities with trinexapac-ethyl 
tolerances are treated. The acute dietary exposure was only estimated 
for females 13 to 49 years old based on an in utero effect (decrease in 
mean number of fetuses/litter and an increase in post-implantation 
loss) identified in the rabbit developmental study. An endpoint of 
concern was not identified for the general U.S. population; however, 
the acute dietary assessment will ensure protection of women that may 
become pregnant.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data

[[Page 28846]]

from the USDA 2003-2008 (NHANES/WWEIA). As to residue levels in food, 
EPA assumed that residues are present in all commodities at the 
tolerance level and that 100% of all commodities with trinexapac-ethyl 
tolerances are treated.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that trinexapac-ethyl 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 and/or PCT information in the 
dietary assessment for trinexapac-ethyl. 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 trinexapac-ethyl in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of trinexapac-ethyl. 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 Pesticide Root Zone Model Ground 
Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of 
trinexapac-ethyl for acute exposures are estimated to be 31.68 parts 
per billion (ppb) for surface water and 0.116 ppb for ground water. The 
EDWCs of trinexapac-ethyl for chronic exposures for non-cancer 
assessments are estimated to be 31.68 ppb for surface water and 0.054 
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 31.68 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 31.68 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). Trinexapac-ethyl is 
currently registered for the following uses that could result in 
residential exposures: Residential lawns, athletic fields, parks, and 
golf courses. EPA assessed residential exposure using the following 
assumptions: That homeowner handlers wear shorts, short-sleeved shirts, 
socks, and shoes, and that they complete all tasks associated with the 
use of a pesticide product including mixing/loading, if needed, as well 
as the application. Residential handler exposure scenarios for both 
dermal and inhalation are considered to be short-term only, due to the 
infrequent use patterns associated with homeowner products.
    EPA uses the term ``post-application'' to describe exposure to 
individuals that occur as a result of being in an environment that has 
been previously treated with a pesticide. Trinexapac-ethyl can be used 
in many areas that can be frequented by the general population 
including residential areas (e.g., home lawns, recreational turf). As a 
result, individuals can be exposed by entering these areas if they have 
been previously treated. Therefore, short-and intermediate-term dermal 
post-application exposures and risks were also assessed for trinexapac-
ethyl. There is the potential for dermal and incidental oral exposure 
to children; however, since there is no toxicological endpoint of 
concern for that route, a quantitative assessment was not conducted. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 
trinexapac-ethyl to share a common mechanism of toxicity with any other 
substances, and trinexapac-ethyl does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that trinexapac-ethyl 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 Food Quality 
Protection Act Safety Factor (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. Evidence of increased 
qualitative and/or quantitative susceptibility of the offspring was 
seen only at high doses in the developmental rat and rabbit studies, 
and in the rat reproduction study. Developmental toxicity in the rat 
was only observed at the limit dose (increased incidence of 
asymmetrical sternebrae at 1,000 mg/kg) in the absence of maternal 
toxicity. In the rabbit, no maternal toxicity was demonstrated at the 
highest dose tested (360 mg/kg/day), but there was a decrease in the 
mean number of fetuses/litter and an increase in post-implantation loss 
and early resorptions at this dose level.
    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 trinexapac-ethyl is complete.
    ii. There is no indication that trinexapac-ethyl is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional Uncertainty Factor's to account for neurotoxicity.
    iii. Although, there is evidence of susceptibility in the rat and 
rabbit developmental studies and qualitative susceptibility in the 2-
generation rat reproduction study, these effects only occurred at the 
highest doses tested for each study, and there were clearly identified 
NOAELs/LOAELs for the rabbit developmental study, the rat developmental 
study and for the reproduction study for each fetal/offspring effect. 
Therefore, there are no residual concerns with respect to developmental 
and reproductive effects.

[[Page 28847]]

    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 ground and surface water modeling used 
to assess exposure to trinexapac-ethyl 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 
trinexapac-ethyl.

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. Therefore, acute aggregate risk is equivalent to the 
acute dietary risk as discussed in Unit III.C.1.i. All risk estimates 
are below EPA's level of concern. The acute dietary exposure estimate 
for females 13 to 49 years old will only utilize 2% of the aPAD, which 
is well below the Agency's level of concern (100% of the aPAD).
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
trinexapac-ethyl from food and water will utilize 6% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure.
    3. Short- and intermediate-term risk: Short- and immediate-term 
aggregate exposure take into account short-term and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Trinexapac-ethyl is 
currently registered for uses that could result in short- and 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with short-term and intermediate-term residential exposures to 
trinexapac-ethyl. The short- and intermediate-term toxicological 
endpoints for trinexapac-ethyl are the same for each route of exposure. 
Therefore, for residential exposure scenarios, only short-term 
exposures were assessed, and are considered to be protective of 
intermediate-term exposure and risk.
    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 4500 for children 
11-16 years old and 230 for adult females. Because EPA's level of 
concern for trinexapac-ethyl is a MOE of 100 or below, these MOEs are 
not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, chemical name 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 trinexapac-ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method GRM020.01A, which utilizes 
high performance liquid chromatography with triple-quadrupole mass 
spectrometry (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: 
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 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 a MRL for trinexapac-ethyl.

C. Revisions to Petitioned-For Tolerances

    EPA revised the petitioned-for tolerances on rye which were 
determined by extrapolating from residue data on barley. EPA concurs 
with translating from the existing cereal grains, however, from a 
residue perspective, rye is more similar to wheat than to barley. Since 
the tolerances for wheat commodities are higher than the tolerances for 
barley commodities, EPA has revised the tolerances for rye to be 
consistent with the wheat tolerances. The use of the higher wheat 
tolerances also represents a more conservative (protective) approach 
for assessing risk from total residues.

 V. Conclusion

    Therefore, tolerances are established for residues of trinexapac-
ethyl, (4-(cyclopropyl-a-hydroxy-methylene)-3,5-dioxo-
cyclohexanecarboxylic acid ethyl ester), and the associated metabolite 
trinexapac, (4-(cyclopropylhydroxymethylene)-3,5-
dioxocyclohexanecarboxylic acid), calculated as the stoichiometric 
equivalent of trinexapac-ethyl, in or on rice, bran at 1.5 ppm; rice, 
grain at 0.4 ppm; rice, straw at 0.07 ppm; rice, wild, grain at 0.4 
ppm; rye, bran at 6.0 ppm; rye, grain at 4.0 ppm; rye, hay at 1.5 ppm; 
and rye, straw at 0.9 ppm.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action 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 action 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

[[Page 28848]]

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 action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(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 (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: May 8, 2015.
G. Jeffery Herndon,
Acting 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 180.662, is amended by alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:

Sec.  180.662  Trinexapac-ethyl; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Rice, bran.................................................          1.5
Rice, grain................................................          0.4
Rice, straw................................................         0.07
Rice, wild, grain..........................................          0.4
Rye, bran..................................................          6.0
Rye, grain.................................................          4.0
Rye, hay...................................................          1.5
Rye, straw.................................................          0.9
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-11972 Filed 5-19-15; 8:45 am]
 BILLING CODE 6560-50-P