
[Federal Register Volume 84, Number 59 (Wednesday, March 27, 2019)]
[Rules and Regulations]
[Pages 11416-11420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05877]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0194; FRL-9989-65]


Sulfometuron-methyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
sulfometuron-methyl in or on sugarcane, cane. E.I. du Pont de Nemours 
and Company requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 27, 2019. Objections and 
requests for hearings must be received on or before May 28, 2019, 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-2017-0194, 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 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: 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 
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-2017-0194 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 
May 28, 2019. 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-2017-0194, 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 September 15, 2017 (82 FR 43352) (FRL-
9965-43), 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 
6E8529) by E. I. du Pont de Nemours and Company, 974 Centre Road, 
Wilmington, Delaware 19805, now Corteva Agriscience after E.I. du Pont 
de Nemours and Company merged with Dow AgroScience. The petition 
requested that 40 CFR 180 be amended by establishing tolerances for 
residues of the herbicide sulfometuron-methyl, in or on sugarcane, 
cane; sugarcane, sugar, refined; and sugarcane, molasses at 0.01 parts 
per million (ppm). That document referenced a summary of the petition 
prepared by E. I. du Pont de Nemours and Company, the registrant, which 
is available in the docket, http://www.regulations.gov. One comment was 
received in response to the notice of filing, and the Agency's response 
can be found in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
determined a tolerance of 0.1 sugarcane, cane is appropriate, but that 
tolerances on sugarcane, sugar, refined and sugarcane, molasses is not 
needed. The reasons for these changes are further explained in Unit 
IV.D.

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

[[Page 11417]]

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 sulfometuron-methyl including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with sulfometuron-
methyl 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 primary toxic effect in the toxicological database is changes 
in hematological parameters and body weight decrements. There is no 
evidence that sulfometuron-methyl is a developmental toxicant based on 
a prenatal developmental study in rats and increased susceptibility was 
not commonly observed in the database for other registered sulfonylurea 
herbicides (SUs). There is no evidence of neurotoxicity or 
immunotoxicity in the toxicology databased for sulfometuron-methyl. 
Sulfometuron-methyl is classified as ``not likely to be carcinogenic to 
humans'' based on lack of treatment-related increases in tumor 
incidence compared to controls in the mouse carcinogenicity study and 
negative findings in the genotoxicity toxicity studies. Sulfometuron-
methyl has low acute toxicity via oral, dermal, and inhalation routes 
of exposure. It shows minimal eye irritation and is not a dermal 
irritant or sensitizer. Specific information on the studies received 
and the nature of the adverse effects caused by sulfometuron-methyl 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 ``Sulfometuron-Methyl. 
Human Health Risk Assessment for a Tolerance without a U.S. 
Registration for Residues in/on Imported Sugarcane'' at pages 18-20 in 
docket ID number EPA-HQ-OPP-2017-0194.

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 NOAEL and 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 used for human risk 
assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Sulfometuron-methyl for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)......  A dose and endpoint of concern attributable to a single dose was not
                                        observed at doses relevant for human health risk assessment.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL = 27.5 mg/kg/day   Chronic RfD = 0.275 mg/  Chronic Oral Toxicity
                                       UFA = 10x..............   kg/day                   Study (dog) LOAEL =
                                       UFH = 10x..............  cPAD = 0.275 mg/kg/day.   148.5 mg/kg/day based
                                       FQPA SF = 1x...........                            on decreases in body-
                                                                                          weight gain in males,
                                                                                          hemolytic anemia, and
                                                                                          a slight increase in
                                                                                          alkaline phosphates in
                                                                                          both sexes.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....  Sulfometuron-methyl is classified as ``not likely to be carcinogenic to
                                        humans'' based on lack of treatment-related increases in tumor incidence
                                        compared to controls in the mouse carcinogenicity study and negative
                                        findings in the mutagenicity/genetic toxicity studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population
  adjusted dose (c = chronic). RfD = reference dose. 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 sulfometuron-methyl, EPA considered exposure under the 
petitioned-for tolerances. EPA assessed dietary exposures from 
sulfometuron-methyl 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. No such effects were

[[Page 11418]]

identified in the toxicological studies for sulfometuron-methyl; 
therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture (USDA) 2003-2008 Nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII). As to residue levels in 
food, EPA assumed 100% crop treated (CT) and used tolerance-level 
residues for the sugarcane commodities. The 2018 default processing 
factors were used (in this case, the factors were 1 for sugarcane 
commodities).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that sulfometuron-methyl 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 sulfometuron-methyl. Tolerance level residues 
and/or 100% CT were assumed for sugarcane.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for sulfometuron-methyl in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of sulfometuron-methyl. 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.
    Instead of generating chemical-specific estimated drinking water 
concentrations (EDWCs) for sulfometuron-methyl, EPA used model inputs 
(rate, soil mobility, persistence) from all the sulfonylurea herbicides 
(sulfometuron-methyl is a sulfonylurea herbicide) to determine coarse-
screen estimates that should exceed upper-bound, chemical-specific 
EDWCs for any SU. The resulting coarse-screen EDWCs generated with the 
Pesticide Root Zone Model Ground Water (PRZM GW) were higher than the 
surface water estimates and were used as conservative estimates of 
potential residues from sulfometuron-methyl in drinking water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.492 ppm 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). Sulfometuron-methyl 
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.''
    In 2016, EPA's Office of Pesticide Programs released a guidance 
document entitled, Pesticide Cumulative Risk Assessment: Framework for 
Screening Analysis https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework. EPA has 
utilized this framework for sulfometuron-methyl and determined that 
although sulfometuron-methyl shares some chemical and/or toxicological 
characteristics (e.g., chemical structure or apical endpoint) with 
other pesticides, the toxicological database does not support a 
testable hypothesis for a common mechanism of action. No further data 
are required to determine that no common mechanism of toxicity exists 
for sulfometuron-methyl and other pesticides, and no further cumulative 
evaluation is necessary for sulfometuron-methyl.

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. There is no evidence that 
sulfometuron-methyl is a developmental toxicant based on a prenatal 
developmental study in rats and increased susceptibility was not 
commonly observed in the database for other registered SUs.
    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 sulfometuron-methyl is complete.
    ii. There is no indication that sulfometuron-methyl is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that sulfometuron-methyl results in 
increased susceptibility in rabbits in a prenatal developmental study. 
EPA has concluded based on a weight-of-evidence approach that the rat 
developmental and reproduction toxicity studies are not required for 
sulfometuron-methyl at this time for the following reasons: (1) 
Increased susceptibility was not commonly observed in the SU database; 
and (2) the chronic oral dog study, which is the study used to 
establish points of departure for sulfometuron-methyl, provides similar 
or lower NOAEL/LOAEL values than the rat developmental and rat 
reproduction toxicity studies across the SU database.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to sulfometuron-methyl in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
sulfometuron-methyl.

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

[[Page 11419]]

exposure estimates from dietary consumption of food and drinking water. 
No adverse effect resulting from a single oral exposure was identified 
and no acute dietary endpoint was selected. Therefore, sulfometuron-
methyl is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
sulfometuron-methyl from food and water will utilize 9.7% of the cPAD 
for all infants (<1 year old), the population group receiving the 
greatest exposure. There are no residential uses for sulfometuron-
methyl; therefore, the chronic aggregate risk assessment is equivalent 
to the chronic dietary assessment. There are no chronic dietary risks 
of concern.
    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). Because there 
are no uses for sulfometuron-methyl that result in residential 
exposures, the short-term aggregate assessment is equivalent to the 
chronic dietary assessment. There are no chronic dietary risks of 
concern as described above.
    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). Because there are no uses for sulfometuron-methyl that result 
in residential exposures, the intermediate-term aggregate assessment is 
equivalent to the chronic dietary assessment. There are no chronic 
dietary risks of concern as described above.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in the rodent mouse carcinogenicity study 
and negative findings in the mutagenicity/genetic toxicity studies, 
sulfometuron-methyl 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 sulfometuron-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography-tandem 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 sulfometuron-methyl.

C. Response to Comments

    One comment was submitted insisting that no residues of 
sulfometuron-methyl be permitted in food, although no additional 
information was provided that would support a conclusion that the 
tolerances requested for sulfometuron-methyl are not safe. Although 
some individuals do not want pesticides to be used on food, the FFDCA 
authorizes EPA to establish tolerances that permit certain levels of 
pesticide residues in or on food when the Agency can determine that 
such residues are safe. EPA has made that determination for the 
tolerances subject to this action, and the commenter provided no 
information to support a determination that the tolerance is not safe.

D. Revisions to Petitioned-For Tolerances

    The petitioner requested a tolerance for residues of 0.01 ppm in/on 
sugarcane, cane; sugarcane, sugar, refined; and sugarcane, molasses. 
The residue data support a tolerance on sugarcane, cane of 0.1 ppm. 
This value is also harmonized with the MRL established in the major 
exporting country, Brazil. A value of 0.01 ppm may create a perceived 
trade irritant if the U.S. tolerance is lower than the MRL in the major 
exporting country. Tolerances for residues in/on sugarcane, sugar, 
refined and sugarcane, molasses are not needed, since residues are not 
expected to concentrate in the processed commodities.

V. Conclusion

    Therefore, a tolerance is established for residues of sulfometuron-
methyl, in or on sugarcane, cane at 0.1 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) nor is considered a regulatory 
action under Executive Order 13771, entitled ``Reducing Regulations and 
Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). 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

[[Page 11420]]

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: March 18, 2019.
Donna Davis,
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. Add Sec.  180.704 to subpart C to read as follows:


Sec.  180.704   Sulfometuron-methyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide sulfometuron-methyl, including its metabolites and 
degradates, in or on the commodity in the table below. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only sulfometuron-methyl, (methyl 2-[[[[(4,6-dimethyl-2-
pyrimidinyl)amino]carbonyl]amino]sulfonyl]benzoate), in or on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Sugarcane, cane \1\.....................................             0.1
------------------------------------------------------------------------
\1\ There are no U.S. Registrations on Sugarcane as of September 24,
  2018.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2019-05877 Filed 3-26-19; 8:45 am]
 BILLING CODE 6560-50-P


