82 FR 31471 - Prosulfuron; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 129 (July 7, 2017)

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).

[Federal Register Volume 82, Number 129 (Friday, July 7, 2017)]
[Rules and Regulations]
[Pages 31471-31476]
From the Federal Register Online  [www.thefederalregister.org]
[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 (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: Michael L. Goodis, 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: 
[email protected].

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.

[[Page 31472]]

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

[[Page 31473]]

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.

[[Page 31474]]

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.

[[Page 31475]]

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: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

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

[[Page 31476]]

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