[Federal Register Volume 82, Number 129 (Friday, July 7, 2017)]
[Rules and Regulations]
[Pages 31471-31476]
[FR Doc No: 2017-14315]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0218; FRL-9962-97]

Prosulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
prosulfuron in or on grain, cereal, forage, fodder, and straw, group
16, stover; grain, cereal, forage, fodder, and straw, group 16, forage;
grain, cereal, forage, fodder, and straw, group 16, hay; grain, cereal,
forage, fodder, and straw, group 16, straw; and grain, cereal, group
15. Syngenta Crop Protection, LLC requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 7, 2017. Objections and
requests for hearings must be received on or before September 5, 2017,
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-2016-0218, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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
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-2016-0218 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 5, 2017. 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-2016-0218, 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 May 19, 2016 (81 FR 31581) (FRL-9946-
02), 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
6F8455) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR 180.481 be amended by
establishing tolerances for residues of the herbicide prosulfuron, (N-
[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]-2-(3,3,3-
trifluoropropyl)benzenesulfonamide), in or on grain, cereal, forage,
fodder, and straw, group 16, fodder at 0.01 parts per million (ppm);
grain, cereal, forage, fodder, and straw, group 16, forage at 0.10 ppm;
grain, cereal, forage, fodder, and straw, group 16, hay at 0.20 ppm;
grain, cereal, forage, fodder, and straw, group 16, straw at 0.02 ppm;
and grain, cereal, group 15 at 0.01 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
revised the commodity definition from grain, cereal, forage, fodder,
and straw, group 16, fodder to grain, cereal, forage, fodder, and
straw, group 16, stover. 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 prosulfuron including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with prosulfuron follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The most prevalent effect observed across species and study
durations following administration of prosulfuron was decreased body
weight observed in subchronic and chronic oral toxicity studies in rats
and dogs. Additionally, subchronic and chronic oral toxicity studies in
dogs showed decreased hematological parameters and hepatic toxicity.
Evidence of neurotoxicity was observed in an acute neurotoxicity study
but not in the subchronic neurotoxicity study. The neurological effects
seen in the acute neurotoxicity study were transient, affecting primary
sensorimotor and gait functions. In a developmental range-finding study
in rabbits, ataxia, hypoactivity, and neuropathology were observed
starting at doses of 150 mg/kg/day. However, these potential signs of
neurotoxicity were not consistent with findings in the two main
developmental studies in rabbits where there were no signs of
neurotoxicity observed up to 200 mg/kg/day. Additionally, other
repeated dosing studies in the rat, mouse, and dog did not show
evidence of neurotoxicity. There is no evidence that prosulfuron is an
immunotoxic chemical. Prosulfuron is classified as ``Not Likely to Be
Carcinogenic to Humans'' based on the lack of evidence of
carcinogenicity in mice and rats and no concern for mutagenicity.
Prosulfuron has low acute toxicity by the oral, dermal, and inhalation
routes of exposure, it is not considered an eye or skin irritant and it
is not a skin sensitizer.
    There was no evidence from the developmental and reproductive
studies of increased susceptibility in rat or rabbit fetuses. In the
first of two rabbit developmental studies, there were no signs of
maternal or developmental toxicity. The second rabbit (tested using
higher doses than the first) and the rat developmental studies showed
dose-related increases in small fetuses and skeletal effects but these
occurred at maternally toxic doses. In the reproductive study in rats,
decreases in body weights were noted for both the adults of the
P0 and P1 generations and for the F1
and F2 pups.
    Specific information on the studies received and the nature of the
adverse effects caused by prosulfuron 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 Prosulfuron. Human Health Risk
Assessment in Support of a Section 3 Petition for the Expansion of Crop
Groups 15 and 16 to Include Permanent Tolerances for Residues of
Prosulfuron in Rice, pages 9-12 in docket ID number EPA-HQ-OPP-2016-
0218.

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://www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for prosulfuron used for

human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Prosulfuron for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Females 13-49       NOAEL = 10 mg/kg/day  Acute RfD = 0.1 mg/  Acute Neurotoxicity Study--Rat
 years of age) (General            UFA = 10x...........   kg/day.             MRID 43387703
 population including infants and  UFH = 10x FQPA SF =   aPAD = 0.1 mg/kg/    LOAEL = 250 mg/kg/day based on
 children).                         1x.                   day.                 abnormal gait in females.
Chronic dietary (All populations)  NOAEL = 5.3 mg/kg/    Chronic RfD = 0.053  Subchronic Oral Toxicity Study--
                                    day.                  mg/kg/day.           Dog
                                   UFA = 10x...........  cPAD = 0.053 mg/kg/  MRID 42685230
                                   UFH = 10x...........   day.                LOAEL = 54 mg/kg/day based on
                                   FQPA SF = 1x........                        decreased feed efficiency,
                                                                               hematological findings and
                                                                               hepatotoxicity in both sexes.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)     Prosulfuron is classified as ``Not Likely to Be Carcinogenic to Humans''
                                      based on the lack of evidence of carcinogenicity in mice and rats and no
                                                              concern for mutagenicity.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to prosulfuron, EPA considered exposure under the petitioned-
for tolerances as well as all existing prosulfuron tolerances in 40 CFR
180.481. EPA assessed dietary exposures from prosulfuron 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 prosulfuron. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) Nationwide Health and Nutrition
Examination Survey, What We Eat In America (NHANES/WWEIA) conducted
from 2003-2008. As to residue levels in food, the acute dietary
analysis was obtained from the Dietary Exposure Evaluation Model using
the Food Commodity Intake Database (DEEM-FCID; version 3.18) and
assumed 100 percent crop treated (PCT) and tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA NHANES/
WWEIA conducted from 2003-2008. As to residue levels in food, the
chronic dietary analysis was obtained from the DEEM-FCID; version 3.18
database and assumed 100 PCT and tolerance-level residues.
    iii. Cancer. EPA has concluded that prosulfuron 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 prosulfuron. 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 prosulfuron in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of prosulfuron. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Tier 1 Rice Model and Pesticide Root Zone Model Ground
Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of
prosulfuron for both acute exposures and chronic exposures for non-
cancer assessments are estimated to be 37 parts per billion (ppb) for
both surface water and ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute and chronic dietary
risk assessment, the water concentration value of 37 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). Prosulfuron 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.''
    EPA has not found prosulfuron to share a common mechanism of
toxicity with any other substances, and prosulfuron does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
prosulfuron 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulativeassessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for prosulfuron includes a developmental toxicity
study in the rat, two developmental toxicity studies and a range-
finding developmental study in the rabbit, and a 2-generation
reproduction toxicity study in the rat. There was no evidence of
increased susceptibility of fetuses or offspring in any of these
studies.
    There were no maternal or fetal effects observed at any dose in the
first of two rabbit developmental toxicity studies. In the second
rabbit study and in the rat developmental toxicity study, a dose-
related increase in small fetuses and skeletal effects was observed,
but only in the presence of maternal toxicity (decreased body weight
gain in the rat study; and increases in abortions, decreases in food
consumption and decreased mean body weight gain in the rabbit study).
    In the developmental range-finding study in rabbits, ataxia,
hypoactivity, and neuropathology were observed starting at doses of 150
mg/kg/day. However, these potential signs of neurotoxicity were not
consistent with findings in the two main developmental studies in
rabbits where there were no signs of neurotoxicity observed up to 200
mg/kg/day. In the 2-generation reproduction study in the rat, decreases
in body weight were observed in the F1 and F2
offspring but these occurred at doses in which parental toxicity was
also observed. There was no evidence of neurotoxicity to fetuses or
offspring observed in any of the developmental or reproduction toxicity
studies.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
Food Quality Protection Act Safety Factor (FQPA SF) were reduced to 1x.
That decision is based on the following findings:
    i. The toxicity database for prosulfuron is complete.
    ii. Although there was evidence of neurotoxicity in the acute
neurotoxicity study and the range-finding developmental toxicity rabbit
study, the selected endpoints are protective of these effects since
they were seen at dose levels in excess of those where systemic
toxicity occurred and at doses at least 15-fold higher than the no-
observed adverse effect levels (NOAELs) selected for risk assessment.
Concern is also low since no neurotoxicity was observed in the rest of
the prosulfuron toxicological database, including the subchronic
neurotoxicity study in rats.
    iii. As discussed in Unit III.D.2., there is no evidence that
prosulfuron results in increased susceptibility in in utero rats or
rabbits in the prenatal developmental studies or in young rats in the
2-generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to prosulfuron in drinking water. These assessments
will not underestimate the exposure and risks posed by prosulfuron.

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 prosulfuron will occupy 6.4% of the aPAD for all infants (< 1 years
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
prosulfuron from food and water will utilize 3.9% of the cPAD for all
infants (< 1 years old), the population group receiving the greatest
exposure. There are no residential uses for prosulfuron.
    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).
    A short-term adverse effect was identified; however, prosulfuron is
not registered for any use patterns that would result in short-term
residential exposure. Short-term risk is assessed based on short-term
residential exposure plus chronic dietary exposure. Because there is no
short-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short-term risk), no
further assessment of short-term risk is necessary, and EPA relies on
the chronic dietary risk assessment for evaluating short-term risk for
prosulfuron.
    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
level).
    An intermediate-term adverse effect was identified; however,
prosulfuron is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary 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
prosulfuron.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, prosulfuron 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 prosulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, Method AG-590C (a high
performance liquid chromatography method with column switching and
ultraviolet (UV) detection), is available to enforce the tolerance
expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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 prosulfuron.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the commodity definition from ``grain, cereal,
forage, fodder, and straw, group 16, fodder'' to ``grain, cereal,
forage, fodder, and straw, group 16, stover'' to be consistent with the
general food and feed commodity vocabulary EPA uses for tolerances and
exemptions.

V. Conclusion

    Therefore, tolerances are established for residues of prosulfuron,
(N-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]-2-(3,3,3-
trifluoropropyl)benzenesulfonamide), including its metabolites and
degradates, in or on grain, cereal, forage, fodder, and straw, group
16, stover at 0.01 ppm; grain, cereal, forage, fodder, and straw, group
16, forage at 0.10 ppm; grain, cereal, forage, fodder, and straw, group
16, hay at 0.20 ppm; grain, cereal, forage, fodder, and straw, group
16, straw at 0.02 ppm; and grain, cereal, group 15 at 0.01 ppm.
    In addition, EPA has revised the tolerance expression to clarify
(1) that, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of prosulfuron not specifically mentioned;
and (2) that compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression. EPA has determined that it is reasonable to make
this change final without prior proposal and opportunity for comment,
because public comment is not necessary, in that the change has no
substantive effect on the tolerance, but rather is merely intended to
clarify the existing tolerance expression.

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 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: June 8, 2017.
Michael L. Goodis,
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. In Sec.  180.481, paragraph (a) is revised to read as follows:

Sec.  180.481   Prosulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of
prosulfuron,

including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only prosulfuron (N-[[(4-methoxy-6-
methyl-1,3,5-triazin-2-yl)amino]carbonyl]-2-(3,3,3-trifluoropropyl)
benzenesulfonamide) in or on the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Grain, cereal, forage, fodder, and straw, group 16,                 0.10
 forage.................................................
Grain, cereal, forage, fodder, and straw, group 16, hay.            0.20
Grain, cereal, forage, fodder, and straw, group 16,                 0.01
 stover.................................................
Grain, cereal, forage, fodder, and straw, group 16,                 0.02
 straw..................................................
Grain, cereal, group 15.................................            0.01
------------------------------------------------------------------------

* * * * *

[FR Doc. 2017-14315 Filed 7-6-17; 8:45 am]
 BILLING CODE 6560-50-P