83_FR_5971 83 FR 5942 - Rimsulfuron; Pesticide Tolerances

83 FR 5942 - Rimsulfuron; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 29 (February 12, 2018)

Page Range5942-5947
FR Document2018-02676

This regulation establishes tolerances, including tolerances with regional registration, for residues of rimsulfuron in or on multiple commodities that are identified and discussed later in this document. In addition, this regulation removes several previously established tolerances that are superseded by this final rule. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 83 Issue 29 (Monday, February 12, 2018)
[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Rules and Regulations]
[Pages 5942-5947]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02676]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0516; FRL-9972-36]


Rimsulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances, including tolerances 
with regional registration, for residues of rimsulfuron in or on 
multiple commodities that are identified and discussed later in this 
document. In addition, this regulation removes several previously 
established tolerances that are superseded by this final rule. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 12, 2018. Objections and 
requests for hearings must be received on or before April 13, 2018, 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-2016-0516, 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-2016-0516 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 
April 13, 2018. 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-2016-0516, 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 Thursday, March 23, 2017 (82 FR 14846) 
(FRL-9957-99), 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 6E8496) by IR-4 Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201W, Princeton, 
NJ 08540. The petition requested that 40 CFR 180.478 be amended by 
establishing tolerances for residues of the herbicide rimsulfuron, N-
[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]-3-(ethylsulfonyl)-2-
pyridinesulfonamide, in or on Berry, low growing, except strawberry, 
subgroup 13-07H at 0.01 parts per million (ppm); Fruit, citrus, group 
10-10 at 0.01 ppm; Fruit, pome, group 11-10 at 0.01 ppm; Fruit, small, 
vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm; 
Fruit, stone, group 12-12 at 0.01 ppm; Nut,

[[Page 5943]]

tree, group 14-12 at 0.01 ppm; Vegetable, tuberous and corm, subgroup 
1C at 0.1 ppm; and tolerances with regional restrictions in or on 
Fescue, forage at 0.01 ppm; Fescue, hay at 0.01 ppm; Ryegrass, 
perennial, forage at 0.01 ppm; and Ryegrass, perennial, hay at 0.01 
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. There were no comments 
received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerance levels that vary from what the petition 
requested. The reason for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for rimsulfuron including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with rimsulfuron 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 toxicity database indicates that target organs for rimsulfuron 
are the liver and kidney in the rat and dog, along with the testis and 
blood in the mouse and dog. In the mouse, the stomach was also a target 
organ.
    Adverse changes in body weight and food consumption were observed 
in rats, mice and dogs. In subchronic and chronic toxicity studies in 
rats, toxic effects included decreased body weight, decreased body 
weight gain, increased relative liver and absolute kidney weights, and 
diuresis. In the subchronic study in mice, increased red blood cell and 
hemoglobin, and decreased body weight gain and food efficiency were 
observed. In the chronic study in mice, decreased body weight, 
increased incidences of dilation and cysts in the glandular stomach, 
and degeneration of the testicular artery and tunica albuginea were 
observed. In the subchronic study in dogs, diuresis was indicated by 
urinary volume, platelet concentration and kidney weights accompanied 
by decreased urinary osmolality. In the chronic study in dogs, 
increased absolute liver and kidney weights, increased seminiferous 
tubule degeneration, and increased number of spermatid giant cells 
present in epididymides in males were observed.
    In the developmental toxicity study in rats, no toxicity was seen 
at the highest dose tested (HDT). In the developmental toxicity study 
in rabbits, and in the 2-generation reproduction toxicity study in 
rats, developmental/offspring toxicity was seen in the presence of 
maternal/systemic toxicity and at similar dose levels. There is no 
quantitative or qualitative evidence of increased susceptibility 
following pre- and/or post-natal exposures in the developmental and 
reproduction studies.
    There is no indication in the database that rimsulfuron is 
neurotoxic or immunotoxic. Rimsulfuron is not mutagenic and has been 
classified as ``not likely to be carcinogenic to humans,'' based on the 
lack of evidence for carcinogenicity in studies conducted in rats and 
mice.
    Specific information on the studies received and the nature of the 
adverse effects caused by rimsulfuron 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 entitled, ``SUBJECT: Rimsulfuron. Human 
Health Risk Assessment in Support of a Petition (PP#6E8496) for the 
Establishment of Permanent Tolerances on Tuberous and Corm Vegetable 
Subgroup 1C, Small Vine Climbing Fruit Except Fuzzy Kiwifruit Subgroup 
13-07F, Low Growing Berry Except Strawberry Subgroup 13-07H, Tolerances 
with Regional Registrations for Ryegrass and Fescue and Crop Group 
Conversions for Citrus Fruit Group 10-10, Pome Fruit Group 11-10, Stone 
Fruit Group 12-12, and Tree Nut Group 14-12,'' dated May 5, 2017 at pp. 
31-34 in docket ID number EPA-HQ-OPP-2016-0516.

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-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for rimsulfuron used for 
human risk assessment is shown in Table 1 of this unit.

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                    Table 1--Summary of Toxicological Doses and Endpoints for Rimsulfuron 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 (All populations)..  An endpoint attributable to a single dose was not identified in the database.
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Chronic dietary (All populations)  NOAEL= 11.8 mg/kg/    Chronic RfD = 0.118  Combined Chronic/Carcinogenicity--
                                    day.                  mg/kg/day.           Rat.
                                   UFA = 10x...........  cPAD = 0.118 mg/kg/  LOAEL = 121 mg/kg/day based on
                                   UFH = 10x...........   day.                 decreased body weight gains and
                                   FQPA SF = 1x........                        liver effects.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)   Rimsulfuron is considered ``not likely to be carcinogenic to humans'' due to
                                        the absence of tumors in the available rat and mouse carcinogenicity
                                                                      studies.
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FQPA SF = Food Quality Protection Act Safety Factor, NOAEL = no observed adverse effect level, LOAEL = lowest
  observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose,
  LOC = level of concern, 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 rimsulfuron, EPA considered exposure under the petitioned-
for tolerances as well as all existing rimsulfuron tolerances in 40 CFR 
180.478. EPA assessed dietary exposures from rimsulfuron 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 
identified in the toxicological studies for rimsulfuron; 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 National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, EPA assumed that rimsulfuron residues were 
present at tolerance levels in all commodities for which tolerances 
have been established and currently proposed, and 100 percent crop 
treated (PCT) with rimsulfuron.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that rimsulfuron 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 or PCT information in the dietary 
assessment for rimsulfuron. Tolerance level residues and 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 rimsulfuron in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of rimsulfuron. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticides in Flooded Applications Model (PFAM) and 
the Wisconsin cranberry (worst case) scenario to conduct an assessment 
of surface water exposure to total toxic residue (TTR) of rimsulfuron 
(PFAM model was developed specifically for regulatory applications to 
estimate exposure for pesticides used in flooded agriculture such as 
rice paddies and cranberry bogs) and Pesticide Root Zone Model Ground 
Water (PRZM GW) and the Tier I assessment for applications of 
rimsulfuron to corn in Wisconsin (worst case), the estimated drinking 
water concentrations (EDWCs) of rimsulfuron for acute exposures are 
estimated to be 9.59 parts per billion (ppb) for surface water and 22.2 
ppb for ground water. Chronic exposures for non-cancer assessments are 
estimated to be 1.70 ppb for surface water and 19.7 ppb for ground 
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 19.7 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).
    Rimsulfuron 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.''
    Rimsulfuron belongs to the class of pesticides known as 
sulfonylureas (SUs). The SUs share a core chemical structure with 
varying degrees of structural similarity. In addition, the SUs share a 
pesticidal mode of action (i.e., the inhibition of acetolactate 
synthase (ALS)), although the function of ALS in humans is unknown and 
the relevance of this mode of action (MOA) in humans in unclear. Based 
on toxicity studies, the SUs do not share a common toxicological 
profile; instead the target organs vary among the class and are often 
unspecific, such as changes in body weight or general effects on the 
liver. Further dividing the SUs into subclasses based on the urea 
substituent did not result in a clear association of a target organ 
with any particular substructure.
    Based on the weight of the evidence, considering the lack of common 
toxicological profile of the SUs, the uncertainty in the human 
relevance of ALS inhibition, and the lack of

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mammalian MOA data, a testable hypothesis for a common mechanism of 
action cannot be identified. Therefore, the Agency concludes that no 
common mechanism of toxicity exists among these pesticides and a 
cumulative risk assessment (CRA) approach is not appropriate for this 
class of pesticides. For further explanation, see ``SUBJECT: 
Sulfonylureas: Screening Analysis of Toxicological Profiles to Consider 
Whether a Candidate Common Mechanism Group Can Be Established'', dated 
9/9/2015, found at http://www.regulations.gov in docket ID number EPA-
HQ-OPP-2016-0516.
    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 website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-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 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. In the developmental 
toxicity study in rats, no developmental toxicity was seen at the 
highest dose tested. In the developmental toxicity study in rabbits and 
in the 2-generation reproductive study in rats, developmental and 
offspring toxicity were seen only in the presence of maternal/systemic 
toxicity. There is no evidence of quantitative or qualitative increased 
susceptibility following pre- and/or postnatal exposures to 
rimsulfuron.
    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 rimsulfuron is complete.
    ii. There is no indication that rimsulfuron is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or increased SF to account for neurotoxicity.
    iii. There is no evidence that rimsulfuron 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. No acute toxicological endpoint was identified. The chronic 
dietary food and drinking water exposure assessment utilizes tolerance-
level residues and 100 PCT information for all commodities. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to rimsulfuron in drinking water. 
These assessments will not underestimate the exposure and risks posed 
by rimsulfuron.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
rimsulfuron 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 
rimsulfuron from food and water will utilize 1.5% of the cPAD for all 
infants less than 1 year old, the population group receiving the 
greatest exposure. There are no residential uses for rimsulfuron. 
Therefore, the chronic aggregate risk is the same as the chronic 
dietary risk and not of concern.
    3. Short- and intermediate-term risks. Short- and intermediate-term 
aggregate exposures take into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Because there is no 
short- or intermediate-term residential exposure and chronic dietary 
exposure has already been assessed under the appropriately protective 
cPAD, no further assessment of short- or intermediate-term risk is 
necessary.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, rimsulfuron is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to rimsulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, DuPont method 15033 using high-
performance liquid chromatography/electrospray ionization tandem mass 
spectrometry (HPLC/ESI-MS/MS), is available for determination of 
residues of rimsulfuron in petitioned-for commodities.
    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 MRLs for residues of rimsulfuron in/
on any commodity associated with this action.

C. International Trade Considerations

    In this final rule, EPA is establishing a crop subgroup tolerance 
for subgroup

[[Page 5946]]

1C (vegetable, tuberous and corm, subgroup 1C) at 0.10 ppm. This 
subgroup includes the commodity potato, for which a tolerance is 
currently set at 0.1 ppm. Setting a new tolerance at 0.10 ppm on potato 
as part of subgroup 1C has a theoretically trade restrictive effect on 
the import of potatoes, resulting from rounding to significant figures 
when quantifying residues of rimsulfuron, compared with the current 
tolerance of 0.1 ppm.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA intends to promptly 
publish this action with the WTO. Although he subgroup 1C tolerance is 
being established at 0.10 ppm and is unlikely to impact trade, EPA is 
establishing an expiration date for the existing potato tolerance 
following publication of this rule in order to provide a six-month 
reasonable interval for producers in exporting countries to adapt the 
modified tolerance. Before that date, residues of rimsulfuron on potato 
will be permitted under the current tolerance of 0.1 ppm; after that 
date, residues will need to be in compliance with the new 0.10 ppm 
subgroup 1C tolerance level.
    The tolerance level is appropriate based on available data and 
residues levels resulting from registered use patterns. The tolerance 
level for all subgroup 1C commodities is not discriminatory; the same 
food safety standard contained in the FFDCA applies equally to 
domestically produced and imported foods. None of the other tolerance 
actions taken in this rulemaking restrict permissible pesticide 
residues below currently allowed levels in the United States.
    Any commodities listed in the regulatory text of this document that 
are treated with the pesticides subject to this final rule, and that 
are in the channels of trade following the tolerance revocation, shall 
be subject to FFDCA section 408(1)(5), as established by FQPA. Under 
this unit, any residues of these pesticides in or on such food shall 
not render the food adulterated so long as it is shown to the 
satisfaction of the Food and Drug Administration that:
    1. The residue is present as the result of an application or use of 
the pesticide at a time and in a manner that was lawful under FIFRA.
    2. The residue does not exceed the level that was authorized at the 
time of the application or use to be present on the food under a 
tolerance or exemption from tolerance. Evidence to show that food was 
lawfully treated may include records that verify the dates that the 
pesticide was applied to such food.

D. Revisions to Petitioned-For Tolerances

    EPA is establishing the tolerance level for ``Berry, low growing, 
except strawberry, subgroup 13-07H'' at 0.02 ppm, instead of 0.01 ppm 
as requested, to fully account for residue loss in the field trial 
samples during freezer storage from the time of harvest to the time of 
analysis. Concurrent storage stability samples indicate that as much as 
half of the residue present in the samples may have been lost between 
the time of harvest and the time of analysis; therefore, 0.02 ppm 
(twice LOQ) was selected as the appropriate tolerance for subgroup 13-
07H. In addition, the tolerance for subgroup 1C is being established as 
0.10 ppm rather than 0.1 ppm to conform with the Agency's practice of 
using two significant figures.

V. Conclusion

    Therefore, tolerances are established for residues of rimsulfuron, 
N-[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]-3-(ethylsulfonyl)-2-
pyridinesulfonamide, to be determined by measuring only rimsulfuron, in 
or on Berry, low growing, except strawberry, subgroup 13-07H at 0.02 
ppm; Fruit, citrus, group 10-10 at 0.01 ppm; Fruit, pome, group 11-10 
at 0.01 ppm; Fruit, small, vine climbing, except fuzzy kiwifruit, 
subgroup 13-07F at 0.01 ppm; Fruit, stone, group 12-12 at 0.01 ppm; 
Nut, tree, group 14-12 at 0.01 ppm; Vegetable, tuberous and corm, 
subgroup 1C at 0.10 ppm; and tolerances with regional restriction on 
Fescue, forage at 0.01 ppm; Fescue, hay at 0.01 ppm; Ryegrass, 
perennial, forage at 0.01 ppm; and Ryegrass, perennial, hay at 0.01 
ppm. In addition, the Agency is removing the existing tolerances for 
``fruit, citrus, group 10'', ``fruit, pome, group 11'', ``fruit, pome, 
group 12'', ``grape'', ``nut, tree, group 14'', and ``pistachio'' since 
they are superseded by the tolerances being established in this action. 
Finally, the Agency is establishing a six-month expiration date for the 
existing ``potato'' tolerance 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); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or 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 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).

[[Page 5947]]

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: January 22, 2018.
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.  180.478:
0
i. Remove the entries for ``Fruit, citrus group 10''; ``Fruit, pome, 
group 11''; ``Fruit, stone, group 12''; ``Grape''; ``Nut, tree, group 
14''; and ``Pistachio'' from the table in paragraph (a).
0
ii. Add alphabetically the entries to the table in paragraph (a) 
``Berry, low growing, except strawberry, subgroup 13-07H''; ``Fruit, 
citrus, group 10-10''; ``Fruit, pome, group 11-10''; ``Fruit, small, 
vine climbing, except fuzzy kiwifruit, subgroup 13-07F''; ``Fruit, 
stone, group 12-12''; and ``Nut, tree, group 14-12''.
0
iii. Revise the entry for ``Potato'' in the table in paragraph (a).
0
iv. Add alphabetically the entry to the table in paragraph (a) 
``Vegetable, tuberous and corm, subgroup 1C''.
0
v. Add footnote 1 to the table in paragraph (a).
0
vi. Revise paragraph (c).
    The additions and revisions read as follows:


Sec.  180.478  Rimsulfuron; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Berry, low growing, except strawberry, subgroup 13-07H..            0.02
 
                              * * * * * * *
Fruit, citrus, group 10-10..............................            0.01
Fruit, pome, group 11-10................................            0.01
Fruit, small, vine climbing, except fuzzy kiwifruit,                0.01
 subgroup 13-07F........................................
Fruit, stone, group 12-12...............................            0.01
 
                              * * * * * * *
Nut, tree, group 14-12..................................            0.01
 
                              * * * * * * *
Potato 1................................................             0.1
 
                              * * * * * * *
Vegetable, tuberous and corm, subgroup 1C...............            0.10
------------------------------------------------------------------------
1 This tolerance expires on August 12, 2018.

* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations, as defined in Sec.  180.1(1), are established 
for residues of the herbicide rimsulfuron, including its metabolites 
and degradates, in or on the commodities in the following table. 
Compliance with the tolerance levels specific in the following table is 
to be determined by measuring only rimsulfuron, N-[[(4,6-dimethoxy-2-
pyrimidinyl)amino] carbonyl]-3-(ethylsulfonyl)-2-pyridinesulfonamide.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Fescue, forage..........................................            0.01
Fescue, hay.............................................            0.01
Ryegrass, perennial, forage.............................            0.01
Ryegrass, perennial, hay................................            0.01
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-02676 Filed 2-9-18; 8:45 am]
BILLING CODE 6560-50-P



                                             5942             Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Rules and Regulations

                                             adopted on December 7, 1990 and                         Docket Center (EPA/DC), West William                  objections and requests for a hearing
                                             revised on December 4, 2006.                            Jefferson Clinton Bldg., Rm. 3334, 1301               must be in writing, and must be
                                               (B) Mojave Desert Air Quality                         Constitution Ave. NW, Washington, DC                  received by the Hearing Clerk on or
                                             Management District.                                    20460–0001. The Public Reading Room                   before April 13, 2018. Addresses for
                                               (1) Rule 444, adopted on October 8,                   is open from 8:30 a.m. to 4:30 p.m.,                  mail and hand delivery of objections
                                             1976 and amended on September 25,                       Monday through Friday, excluding legal                and hearing requests are provided in 40
                                             2006.                                                   holidays. The telephone number for the                CFR 178.25(b).
                                               (2) Rule 1106, Marine Coating                         Public Reading Room is (202) 566–1744,                  In addition to filing an objection or
                                             Operations, adopted on August 28, 2006                  and the telephone number for the OPP                  hearing request with the Hearing Clerk
                                             and amended on October 23, 2006.                        Docket is (703) 305–5805. Please review               as described in 40 CFR part 178, please
                                               (3) Previously approved on July 16,                   the visitor instructions and additional               submit a copy of the filing (excluding
                                             2008 in paragraph (c)(350)(i)(B)(2) of                  information about the docket available                any Confidential Business Information
                                             this section and now deleted with                       at http://www.epa.gov/dockets.                        (CBI)) for inclusion in the public docket.
                                             replacement in (c)(498)(i)(B)(1), Rule                  FOR FURTHER INFORMATION CONTACT:                      Information not marked confidential
                                             1106, adopted on August 28, 2006 and                    Michael L. Goodis, Registration Division              pursuant to 40 CFR part 2 may be
                                             amended on October 23, 2006.                            (7505P), Office of Pesticide Programs,                disclosed publicly by EPA without prior
                                             *     *     *    *    *                                 Environmental Protection Agency, 1200                 notice. Submit the non-CBI copy of your
                                               (498) * * *                                           Pennsylvania Ave. NW, Washington, DC                  objection or hearing request, identified
                                               (i) * * *                                             20460–0001; main telephone number:                    by docket ID number EPA–HQ–OPP–
                                               (B) Mojave Desert Air Quality                         (703) 305–7090; email address:                        2016–0516, by one of the following
                                             Management District.                                    RDFRNotices@epa.gov.                                  methods:
                                                                                                                                                             • Federal eRulemaking Portal: http://
                                               (1) Rule 1106, ‘‘Marine and Pleasure                  SUPPLEMENTARY INFORMATION:                            www.regulations.gov. Follow the online
                                             Craft Coating Operations,’’ amended on
                                                                                                     I. General Information                                instructions for submitting comments.
                                             October 24, 2016.
                                                                                                                                                           Do not submit electronically any
                                             [FR Doc. 2018–02669 Filed 2–9–18; 8:45 am]              A. Does this action apply to me?                      information you consider to be CBI or
                                             BILLING CODE 6560–50–P                                     You may be potentially affected by                 other information whose disclosure is
                                                                                                     this action if you are an agricultural                restricted by statute.
                                                                                                     producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                             ENVIRONMENTAL PROTECTION                                pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                             AGENCY                                                  list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.
                                                                                                     Classification System (NAICS) codes is                NW, Washington, DC 20460–0001.
                                             40 CFR Part 180                                                                                                 • Hand Delivery: To make special
                                                                                                     not intended to be exhaustive, but rather
                                             [EPA–HQ–OPP–2016–0516; FRL–9972–36]                     provides a guide to help readers                      arrangements for hand delivery or
                                                                                                     determine whether this document                       delivery of boxed information, please
                                             Rimsulfuron; Pesticide Tolerances                       applies to them. Potentially affected                 follow the instructions at http://
                                             AGENCY:  Environmental Protection                       entities may include:                                 www.epa.gov/dockets/contacts.html.
                                             Agency (EPA).                                              • Crop production (NAICS code 111).                  Additional instructions on
                                                                                                        • Animal production (NAICS code                    commenting or visiting the docket,
                                             ACTION: Final rule.                                                                                           along with more information about
                                                                                                     112).
                                             SUMMARY:    This regulation establishes                    • Food manufacturing (NAICS code                   dockets generally, is available at http://
                                             tolerances, including tolerances with                   311).                                                 www.epa.gov/dockets.
                                             regional registration, for residues of                     • Pesticide manufacturing (NAICS                   II. Summary of Petitioned-For
                                             rimsulfuron in or on multiple                           code 32532).                                          Tolerance
                                             commodities that are identified and                     B. How can I get electronic access to                    In the Federal Register of Thursday,
                                             discussed later in this document. In                    other related information?                            March 23, 2017 (82 FR 14846) (FRL–
                                             addition, this regulation removes                                                                             9957–99), EPA issued a document
                                                                                                        You may access a frequently updated
                                             several previously established                                                                                pursuant to FFDCA section 408(d)(3), 21
                                                                                                     electronic version of EPA’s tolerance
                                             tolerances that are superseded by this                                                                        U.S.C. 346a(d)(3), announcing the filing
                                                                                                     regulations at 40 CFR part 180 through
                                             final rule. Interregional Research Project                                                                    of a pesticide petition (PP 6E8496) by
                                                                                                     the Government Printing Office’s e-CFR
                                             Number 4 (IR–4) requested these                                                                               IR–4 Headquarters, Rutgers, The State
                                                                                                     site at http://www.ecfr.gov/cgi-bin/text-
                                             tolerances under the Federal Food,                                                                            University of New Jersey, 500 College
                                                                                                     idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                             Drug, and Cosmetic Act (FFDCA).                                                                               Road East, Suite 201W, Princeton, NJ
                                                                                                     40tab_02.tpl.
                                             DATES: This regulation is effective                                                                           08540. The petition requested that 40
                                             February 12, 2018. Objections and                       C. How can I file an objection or hearing             CFR 180.478 be amended by
                                             requests for hearings must be received                  request?                                              establishing tolerances for residues of
                                             on or before April 13, 2018, and must                     Under FFDCA section 408(g), 21                      the herbicide rimsulfuron, N-[[(4,6-
                                             be filed in accordance with the                         U.S.C. 346a, any person may file an                   dimethoxy-2-pyrimidinyl)amino]
                                             instructions provided in 40 CFR part                    objection to any aspect of this regulation            carbonyl]-3-(ethylsulfonyl)-2-
                                             178 (see also Unit I.C. of the                          and may also request a hearing on those               pyridinesulfonamide, in or on Berry,
                                             SUPPLEMENTARY INFORMATION).                             objections. You must file your objection              low growing, except strawberry,
                                             ADDRESSES: The docket for this action,                  or request a hearing on this regulation               subgroup 13–07H at 0.01 parts per
daltland on DSKBBV9HB2PROD with RULES




                                             identified by docket identification (ID)                in accordance with the instructions                   million (ppm); Fruit, citrus, group 10–
                                             number EPA–HQ–OPP–2016–0516, is                         provided in 40 CFR part 178. To ensure                10 at 0.01 ppm; Fruit, pome, group 11–
                                             available at http://www.regulations.gov                 proper receipt by EPA, you must                       10 at 0.01 ppm; Fruit, small, vine
                                             or at the Office of Pesticide Programs                  identify docket ID number EPA–HQ–                     climbing, except fuzzy kiwifruit,
                                             Regulatory Public Docket (OPP Docket)                   OPP–2016–0516 in the subject line on                  subgroup 13–07F at 0.01 ppm; Fruit,
                                             in the Environmental Protection Agency                  the first page of your submission. All                stone, group 12–12 at 0.01 ppm; Nut,


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                                                              Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Rules and Regulations                                           5943

                                             tree, group 14–12 at 0.01 ppm;                          studies to human risk. EPA has also                   toxicity studies can be found at http://
                                             Vegetable, tuberous and corm, subgroup                  considered available information                      www.regulations.gov in document
                                             1C at 0.1 ppm; and tolerances with                      concerning the variability of the                     entitled, ‘‘SUBJECT: Rimsulfuron.
                                             regional restrictions in or on Fescue,                  sensitivities of major identifiable                   Human Health Risk Assessment in
                                             forage at 0.01 ppm; Fescue, hay at 0.01                 subgroups of consumers, including                     Support of a Petition (PP#6E8496) for
                                             ppm; Ryegrass, perennial, forage at 0.01                infants and children.                                 the Establishment of Permanent
                                             ppm; and Ryegrass, perennial, hay at                       The toxicity database indicates that               Tolerances on Tuberous and Corm
                                             0.01 ppm. That document referenced a                    target organs for rimsulfuron are the                 Vegetable Subgroup 1C, Small Vine
                                             summary of the petition prepared by E.                  liver and kidney in the rat and dog,                  Climbing Fruit Except Fuzzy Kiwifruit
                                             I. du Pont de Nemours and Company,                      along with the testis and blood in the                Subgroup 13–07F, Low Growing Berry
                                             the registrant, which is available in the               mouse and dog. In the mouse, the                      Except Strawberry Subgroup 13–07H,
                                             docket, http://www.regulations.gov.                     stomach was also a target organ.
                                                                                                                                                           Tolerances with Regional Registrations
                                             There were no comments received in                         Adverse changes in body weight and
                                                                                                                                                           for Ryegrass and Fescue and Crop Group
                                             response to the notice of filing.                       food consumption were observed in
                                                                                                                                                           Conversions for Citrus Fruit Group 10–
                                                Based upon review of the data                        rats, mice and dogs. In subchronic and
                                                                                                     chronic toxicity studies in rats, toxic               10, Pome Fruit Group 11–10, Stone
                                             supporting the petition, EPA is
                                                                                                     effects included decreased body weight,               Fruit Group 12–12, and Tree Nut Group
                                             establishing tolerance levels that vary
                                             from what the petition requested. The                   decreased body weight gain, increased                 14–12,’’ dated May 5, 2017 at pp. 31–
                                             reason for these changes are explained                  relative liver and absolute kidney                    34 in docket ID number EPA–HQ–OPP–
                                             in Unit IV.C.                                           weights, and diuresis. In the subchronic              2016–0516.
                                                                                                     study in mice, increased red blood cell               B. Toxicological Points of Departure/
                                             III. Aggregate Risk Assessment and                      and hemoglobin, and decreased body
                                             Determination of Safety                                                                                       Levels of Concern
                                                                                                     weight gain and food efficiency were
                                                Section 408(b)(2)(A)(i) of FFDCA                     observed. In the chronic study in mice,                  Once a pesticide’s toxicological
                                             allows EPA to establish a tolerance (the                decreased body weight, increased                      profile is determined, EPA identifies
                                             legal limit for a pesticide chemical                    incidences of dilation and cysts in the               toxicological points of departure (POD)
                                             residue in or on a food) only if EPA                    glandular stomach, and degeneration of                and levels of concern to use in
                                             determines that the tolerance is ‘‘safe.’’              the testicular artery and tunica                      evaluating the risk posed by human
                                             Section 408(b)(2)(A)(ii) of FFDCA                       albuginea were observed. In the                       exposure to the pesticide. For hazards
                                             defines ‘‘safe’’ to mean that ‘‘there is a              subchronic study in dogs, diuresis was                that have a threshold below which there
                                             reasonable certainty that no harm will                  indicated by urinary volume, platelet                 is no appreciable risk, the toxicological
                                             result from aggregate exposure to the                   concentration and kidney weights
                                                                                                                                                           POD is used as the basis for derivation
                                             pesticide chemical residue, including                   accompanied by decreased urinary
                                                                                                                                                           of reference values for risk assessment.
                                             all anticipated dietary exposures and all               osmolality. In the chronic study in dogs,
                                                                                                                                                           PODs are developed based on a careful
                                             other exposures for which there is                      increased absolute liver and kidney
                                             reliable information.’’ This includes                   weights, increased seminiferous tubule                analysis of the doses in each
                                             exposure through drinking water and in                  degeneration, and increased number of                 toxicological study to determine the
                                             residential settings, but does not include              spermatid giant cells present in                      dose at which no adverse effects are
                                             occupational exposure. Section                          epididymides in males were observed.                  observed (the NOAEL) and the lowest
                                             408(b)(2)(C) of FFDCA requires EPA to                      In the developmental toxicity study in             dose at which adverse effects of concern
                                             give special consideration to exposure                  rats, no toxicity was seen at the highest             are identified (the LOAEL). Uncertainty/
                                             of infants and children to the pesticide                dose tested (HDT). In the developmental               safety factors are used in conjunction
                                             chemical residue in establishing a                      toxicity study in rabbits, and in the 2-              with the POD to calculate a safe
                                             tolerance and to ‘‘ensure that there is a               generation reproduction toxicity study                exposure level—generally referred to as
                                             reasonable certainty that no harm will                  in rats, developmental/offspring toxicity             a population-adjusted dose (PAD) or a
                                             result to infants and children from                     was seen in the presence of maternal/                 reference dose (RfD)—and a safe margin
                                             aggregate exposure to the pesticide                     systemic toxicity and at similar dose                 of exposure (MOE). For non-threshold
                                             chemical residue . . . .’’                              levels. There is no quantitative or                   risks, the Agency assumes that any
                                                Consistent with FFDCA section                        qualitative evidence of increased                     amount of exposure will lead to some
                                             408(b)(2)(D), and the factors specified in              susceptibility following pre- and/or                  degree of risk. Thus, the Agency
                                             FFDCA section 408(b)(2)(D), EPA has                     post-natal exposures in the                           estimates risk in terms of the probability
                                             reviewed the available scientific data                  developmental and reproduction                        of an occurrence of the adverse effect
                                             and other relevant information in                       studies.                                              expected in a lifetime. For more
                                             support of this action. EPA has                            There is no indication in the database             information on the general principles
                                             sufficient data to assess the hazards of                that rimsulfuron is neurotoxic or                     EPA uses in risk characterization and a
                                             and to make a determination on                          immunotoxic. Rimsulfuron is not                       complete description of the risk
                                             aggregate exposure for rimsulfuron                      mutagenic and has been classified as
                                                                                                                                                           assessment process, see http://
                                             including exposure resulting from the                   ‘‘not likely to be carcinogenic to
                                                                                                                                                           www2.epa.gov/pesticide-science-and-
                                             tolerances established by this action.                  humans,’’ based on the lack of evidence
                                                                                                                                                           assessing-pesticide-risks/assessing-
                                             EPA’s assessment of exposures and risks                 for carcinogenicity in studies conducted
                                                                                                     in rats and mice.                                     human-health-risk-pesticides.
                                             associated with rimsulfuron follows.
daltland on DSKBBV9HB2PROD with RULES




                                                                                                        Specific information on the studies                  A summary of the toxicological
                                             A. Toxicological Profile                                received and the nature of the adverse                endpoints for rimsulfuron used for
                                               EPA has evaluated the available                       effects caused by rimsulfuron as well as              human risk assessment is shown in
                                             toxicity data and considered its validity,              the no-observed-adverse-effect-level                  Table 1 of this unit.
                                             completeness, and reliability as well as                (NOAEL) and the lowest-observed-
                                             the relationship of the results of the                  adverse-effect-level (LOAEL) from the


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                                             5944             Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Rules and Regulations

                                                                  TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR RIMSULFURON FOR
                                                                                   USE IN HUMAN HEALTH RISK ASSESSMENT
                                                                                          Point of                 RfD, PAD, LOC
                                                                                       departure and
                                                    Exposure/scenario                                                  for risk                             Study and toxicological effects
                                                                                      uncertainty/safety            assessment
                                                                                           factors

                                             Acute Dietary (All populations)                               An endpoint attributable to a single dose was not identified in the database.

                                             Chronic dietary (All populations)      NOAEL= 11.8 mg/              Chronic RfD = 0.118       Combined Chronic/Carcinogenicity—Rat.
                                                                                     kg/day.                       mg/kg/day.              LOAEL = 121 mg/kg/day based on decreased body weight
                                                                                    UFA = 10x                    cPAD = 0.118 mg/            gains and liver effects.
                                                                                    UFH = 10x                      kg/day
                                                                                    FQPA SF = 1x

                                             Cancer (Oral, dermal, inhala-          Rimsulfuron is considered ‘‘not likely to be carcinogenic to humans’’ due to the absence of tumors in the avail-
                                               tion).                                                                  able rat and mouse carcinogenicity studies.
                                               FQPA SF = Food Quality Protection Act Safety Factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect
                                             level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, LOC = level of concern, UFA = extrapolation from animal
                                             to human (interspecies), UFH = potential variation in sensitivity among members of the human population (intraspecies).


                                             C. Exposure Assessment                                  residues and 100 PCT were assumed for                     3. From non-dietary exposure. The
                                                1. Dietary exposure from food and                    all food commodities.                                  term ‘‘residential exposure’’ is used in
                                             feed uses. In evaluating dietary                           2. Dietary exposure from drinking                   this document to refer to non-
                                             exposure to rimsulfuron, EPA                            water. The Agency used screening level                 occupational, non-dietary exposure
                                             considered exposure under the                           water exposure models in the dietary                   (e.g., for lawn and garden pest control,
                                             petitioned-for tolerances as well as all                exposure analysis and risk assessment                  indoor pest control, termiticides, and
                                             existing rimsulfuron tolerances in 40                   for rimsulfuron in drinking water. These               flea and tick control on pets).
                                             CFR 180.478. EPA assessed dietary                       simulation models take into account                       Rimsulfuron is not registered for any
                                             exposures from rimsulfuron in food as                   data on the physical, chemical, and fate/              specific use patterns that would result
                                             follows:                                                transport characteristics of rimsulfuron.              in residential exposure.
                                                i. Acute exposure. Quantitative acute                Further information regarding EPA                         4. Cumulative effects from substances
                                             dietary exposure and risk assessments                   drinking water models used in pesticide                with a common mechanism of toxicity.
                                             are performed for a food-use pesticide,                 exposure assessment can be found at                    Section 408(b)(2)(D)(v) of FFDCA
                                             if a toxicological study has indicated the              http://www2.epa.gov/pesticide-science-                 requires that, when considering whether
                                             possibility of an effect of concern                     and-assessing-pesticide-risks/about-                   to establish, modify, or revoke a
                                             occurring as a result of a 1-day or single              water-exposure-models-used-pesticide.                  tolerance, the Agency consider
                                             exposure. No such effects were                                                                                 ‘‘available information’’ concerning the
                                                                                                        Based on the Pesticides in Flooded                  cumulative effects of a particular
                                             identified in the toxicological studies
                                                                                                     Applications Model (PFAM) and the                      pesticide’s residues and ‘‘other
                                             for rimsulfuron; therefore, a quantitative
                                                                                                     Wisconsin cranberry (worst case)                       substances that have a common
                                             acute dietary exposure assessment is
                                                                                                     scenario to conduct an assessment of                   mechanism of toxicity.’’
                                             unnecessary.
                                                ii. Chronic exposure. In conducting                  surface water exposure to total toxic                     Rimsulfuron belongs to the class of
                                             the chronic dietary exposure assessment                 residue (TTR) of rimsulfuron (PFAM                     pesticides known as sulfonylureas
                                             EPA used the food consumption data                      model was developed specifically for                   (SUs). The SUs share a core chemical
                                             from the United States Department of                    regulatory applications to estimate                    structure with varying degrees of
                                             Agriculture (USDA) 2003–2008 National                   exposure for pesticides used in flooded                structural similarity. In addition, the
                                             Health and Nutrition Examination                        agriculture such as rice paddies and                   SUs share a pesticidal mode of action
                                             Survey, What We Eat in America                          cranberry bogs) and Pesticide Root Zone                (i.e., the inhibition of acetolactate
                                             (NHANES/WWEIA). As to residue levels                    Model Ground Water (PRZM GW) and                       synthase (ALS)), although the function
                                             in food, EPA assumed that rimsulfuron                   the Tier I assessment for applications of              of ALS in humans is unknown and the
                                             residues were present at tolerance levels               rimsulfuron to corn in Wisconsin (worst                relevance of this mode of action (MOA)
                                             in all commodities for which tolerances                 case), the estimated drinking water                    in humans in unclear. Based on toxicity
                                             have been established and currently                     concentrations (EDWCs) of rimsulfuron                  studies, the SUs do not share a common
                                             proposed, and 100 percent crop treated                  for acute exposures are estimated to be                toxicological profile; instead the target
                                             (PCT) with rimsulfuron.                                 9.59 parts per billion (ppb) for surface               organs vary among the class and are
                                                iii. Cancer. Based on the data                       water and 22.2 ppb for ground water.                   often unspecific, such as changes in
                                             summarized in Unit III.A., EPA has                      Chronic exposures for non-cancer                       body weight or general effects on the
                                             concluded that rimsulfuron does not                     assessments are estimated to be 1.70                   liver. Further dividing the SUs into
                                             pose a cancer risk to humans. Therefore,                ppb for surface water and 19.7 ppb for                 subclasses based on the urea substituent
                                             a dietary exposure assessment for the                   ground water.                                          did not result in a clear association of
                                                                                                        Modeled estimates of drinking water                 a target organ with any particular
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                                             purpose of assessing cancer risk is
                                             unnecessary.                                            concentrations were directly entered                   substructure.
                                                iv. Anticipated residue and percent                  into the dietary exposure model. For                      Based on the weight of the evidence,
                                             crop treated (PCT) information. EPA did                 chronic dietary risk assessment, the                   considering the lack of common
                                             not use anticipated residue or PCT                      water concentration of value 19.7 ppb                  toxicological profile of the SUs, the
                                             information in the dietary assessment                   was used to assess the contribution to                 uncertainty in the human relevance of
                                             for rimsulfuron. Tolerance level                        drinking water.                                        ALS inhibition, and the lack of


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                                                              Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Rules and Regulations                                           5945

                                             mammalian MOA data, a testable                          developmental neurotoxicity study or                  exposure and chronic dietary exposure
                                             hypothesis for a common mechanism of                    increased SF to account for                           has already been assessed under the
                                             action cannot be identified. Therefore,                 neurotoxicity.                                        appropriately protective cPAD, no
                                             the Agency concludes that no common                       iii. There is no evidence that                      further assessment of short- or
                                             mechanism of toxicity exists among                      rimsulfuron results in increased                      intermediate-term risk is necessary.
                                             these pesticides and a cumulative risk                  susceptibility in in utero rats or rabbits               4. Aggregate cancer risk for U.S.
                                             assessment (CRA) approach is not                        in the prenatal developmental studies or              population. Based on the lack of
                                             appropriate for this class of pesticides.               in young rats in the 2-generation                     evidence of carcinogenicity in two
                                             For further explanation, see ‘‘SUBJECT:                 reproduction study.                                   adequate rodent carcinogenicity studies,
                                             Sulfonylureas: Screening Analysis of                      iv. There are no residual uncertainties             rimsulfuron is not expected to pose a
                                             Toxicological Profiles to Consider                      identified in the exposure databases. No              cancer risk to humans.
                                             Whether a Candidate Common                              acute toxicological endpoint was                         5. Determination of safety. Based on
                                             Mechanism Group Can Be Established’’,                   identified. The chronic dietary food and              these risk assessments, EPA concludes
                                             dated 9/9/2015, found at http://                        drinking water exposure assessment                    that there is a reasonable certainty that
                                             www.regulations.gov in docket ID                        utilizes tolerance-level residues and 100             no harm will result to the general
                                             number EPA–HQ–OPP–2016–0516.                            PCT information for all commodities.                  population, or to infants and children
                                                For information regarding EPA’s                      EPA made conservative (protective)                    from aggregate exposure to rimsulfuron
                                             efforts to determine which chemicals                    assumptions in the ground and surface                 residues.
                                             have a common mechanism of toxicity                     water modeling used to assess exposure
                                             and to evaluate the cumulative effects of               to rimsulfuron in drinking water. These               IV. Other Considerations
                                             such chemicals, see EPA’s website at                    assessments will not underestimate the                A. Analytical Enforcement Methodology
                                             http://www2.epa.gov/pesticide-science-                  exposure and risks posed by
                                             and-assessing-pesticide-risks/                          rimsulfuron.                                             Adequate enforcement methodology,
                                             cumulative-assessment-risk-pesticides.                                                                        DuPont method 15033 using high-
                                                                                                     E. Aggregate Risks and Determination of               performance liquid chromatography/
                                             D. Safety Factor for Infants and                        Safety                                                electrospray ionization tandem mass
                                             Children                                                   EPA determines whether acute and                   spectrometry (HPLC/ESI–MS/MS), is
                                                1. In general. Section 408(b)(2)(C) of               chronic dietary pesticide exposures are               available for determination of residues
                                             FFDCA provides that EPA shall apply                     safe by comparing aggregate exposure                  of rimsulfuron in petitioned-for
                                             an additional tenfold (10X) margin of                   estimates to the acute PAD (aPAD) and                 commodities.
                                             safety for infants and children in the                  chronic PAD (cPAD). For linear cancer                    The method may be requested from:
                                             case of threshold effects to account for                risks, EPA calculates the lifetime                    Chief, Analytical Chemistry Branch,
                                             prenatal and postnatal toxicity and the                 probability of acquiring cancer given the             Environmental Science Center, 701
                                             completeness of the database on toxicity                estimated aggregate exposure. Short-,                 Mapes Rd., Ft. Meade, MD 20755–5350;
                                             and exposure unless EPA determines                      intermediate-, and chronic-term risks                 telephone number: (410) 305–2905;
                                             based on reliable data that a different                 are evaluated by comparing the                        email address: residuemethods@
                                             margin of safety will be safe for infants               estimated aggregate food, water, and                  epa.gov.
                                             and children. This additional margin of                 residential exposure to the appropriate
                                                                                                                                                           B. International Residue Limits
                                             safety is commonly referred to as the                   PODs to ensure that an adequate MOE
                                             FQPA SF. In applying this provision,                    exists.                                                  In making its tolerance decisions, EPA
                                             EPA either retains the default value of                    1. Acute risk. An acute aggregate risk             seeks to harmonize U.S. tolerances with
                                             10X, or uses a different additional safety              assessment takes into account acute                   international standards whenever
                                             factor when reliable data available to                  exposure estimates from dietary                       possible, consistent with U.S. food
                                             EPA support the choice of a different                   consumption of food and drinking                      safety standards and agricultural
                                             factor.                                                 water. No adverse effect resulting from               practices. EPA considers the
                                                2. Prenatal and postnatal sensitivity.               a single oral exposure was identified                 international maximum residue limits
                                             In the developmental toxicity study in                  and no acute dietary endpoint was                     (MRLs) established by the Codex
                                             rats, no developmental toxicity was seen                selected. Therefore, rimsulfuron is not               Alimentarius Commission (Codex), as
                                             at the highest dose tested. In the                      expected to pose an acute risk.                       required by FFDCA section 408(b)(4).
                                             developmental toxicity study in rabbits                    2. Chronic risk. Using the exposure                The Codex Alimentarius is a joint
                                             and in the 2-generation reproductive                    assumptions described in this unit for                United Nations Food and Agriculture
                                             study in rats, developmental and                        chronic exposure, EPA has concluded                   Organization/World Health
                                             offspring toxicity were seen only in the                that chronic exposure to rimsulfuron                  Organization food standards program,
                                             presence of maternal/systemic toxicity.                 from food and water will utilize 1.5% of              and it is recognized as an international
                                             There is no evidence of quantitative or                 the cPAD for all infants less than 1 year             food safety standards-setting
                                             qualitative increased susceptibility                    old, the population group receiving the               organization in trade agreements to
                                             following pre- and/or postnatal                         greatest exposure. There are no                       which the United States is a party. EPA
                                             exposures to rimsulfuron.                               residential uses for rimsulfuron.                     may establish a tolerance that is
                                                3. Conclusion. EPA has determined                    Therefore, the chronic aggregate risk is              different from a Codex MRL; however,
                                             that reliable data show the safety of                   the same as the chronic dietary risk and              FFDCA section 408(b)(4) requires that
                                             infants and children would be                           not of concern.                                       EPA explain the reasons for departing
                                             adequately protected if the FQPA SF                        3. Short- and intermediate-term risks.             from the Codex level.
                                                                                                     Short- and intermediate-term aggregate
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                                             were reduced to 1X. That decision is                                                                             The Codex has not established MRLs
                                             based on the following findings:                        exposures take into account short- and                for residues of rimsulfuron in/on any
                                                i. The toxicity database for                         intermediate-term residential exposure                commodity associated with this action.
                                             rimsulfuron is complete.                                plus chronic exposure to food and water
                                                ii. There is no indication that                      (considered to be a background                        C. International Trade Considerations
                                             rimsulfuron is a neurotoxic chemical                    exposure level). Because there is no                    In this final rule, EPA is establishing
                                             and there is no need for a                              short- or intermediate-term residential               a crop subgroup tolerance for subgroup


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                                             5946             Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Rules and Regulations

                                             1C (vegetable, tuberous and corm,                       D. Revisions to Petitioned-For                        not subject to Executive Order 13211,
                                             subgroup 1C) at 0.10 ppm. This                          Tolerances                                            entitled ‘‘Actions Concerning
                                             subgroup includes the commodity                            EPA is establishing the tolerance level            Regulations That Significantly Affect
                                             potato, for which a tolerance is                        for ‘‘Berry, low growing, except                      Energy Supply, Distribution, or Use’’ (66
                                             currently set at 0.1 ppm. Setting a new                 strawberry, subgroup 13–07H’’ at 0.02                 FR 28355, May 22, 2001); Executive
                                             tolerance at 0.10 ppm on potato as part                 ppm, instead of 0.01 ppm as requested,                Order 13045, entitled ‘‘Protection of
                                             of subgroup 1C has a theoretically trade                                                                      Children from Environmental Health
                                                                                                     to fully account for residue loss in the
                                             restrictive effect on the import of                                                                           Risks and Safety Risks’’ (62 FR 19885,
                                                                                                     field trial samples during freezer storage
                                             potatoes, resulting from rounding to                                                                          April 23, 1997); or Executive Order
                                                                                                     from the time of harvest to the time of
                                             significant figures when quantifying                                                                          13771, entitled ‘‘Reducing Regulations
                                                                                                     analysis. Concurrent storage stability
                                             residues of rimsulfuron, compared with                                                                        and Controlling Regulatory Costs’’ (82
                                                                                                     samples indicate that as much as half of
                                             the current tolerance of 0.1 ppm.                                                                             FR 9339, February 3, 2017). This action
                                                In accordance with the World Trade                   the residue present in the samples may
                                                                                                     have been lost between the time of                    does not contain any information
                                             Organization’s (WTO) Sanitary and                                                                             collections subject to OMB approval
                                             Phytosanitary Measures (SPS)                            harvest and the time of analysis;
                                                                                                     therefore, 0.02 ppm (twice LOQ) was                   under the Paperwork Reduction Act
                                             Agreement, EPA intends to promptly                                                                            (PRA) (44 U.S.C. 3501 et seq.), nor does
                                             publish this action with the WTO.                       selected as the appropriate tolerance for
                                                                                                     subgroup 13–07H. In addition, the                     it require any special considerations
                                             Although he subgroup 1C tolerance is                                                                          under Executive Order 12898, entitled
                                             being established at 0.10 ppm and is                    tolerance for subgroup 1C is being
                                                                                                     established as 0.10 ppm rather than 0.1               ‘‘Federal Actions to Address
                                             unlikely to impact trade, EPA is                                                                              Environmental Justice in Minority
                                             establishing an expiration date for the                 ppm to conform with the Agency’s
                                                                                                     practice of using two significant figures.            Populations and Low-Income
                                             existing potato tolerance following                                                                           Populations’’ (59 FR 7629, February 16,
                                             publication of this rule in order to                    V. Conclusion                                         1994).
                                             provide a six-month reasonable interval                                                                          Since tolerances and exemptions that
                                             for producers in exporting countries to                    Therefore, tolerances are established
                                                                                                     for residues of rimsulfuron, N-[[(4,6-                are established on the basis of a petition
                                             adapt the modified tolerance. Before                                                                          under FFDCA section 408(d), such as
                                             that date, residues of rimsulfuron on                   dimethoxy-2-pyrimidinyl)amino]
                                                                                                     carbonyl]-3-(ethylsulfonyl)-2-                        the tolerance in this final rule, do not
                                             potato will be permitted under the                                                                            require the issuance of a proposed rule,
                                             current tolerance of 0.1 ppm; after that                pyridinesulfonamide, to be determined
                                                                                                     by measuring only rimsulfuron, in or on               the requirements of the Regulatory
                                             date, residues will need to be in                                                                             Flexibility Act (RFA) (5 U.S.C. 601 et
                                             compliance with the new 0.10 ppm                        Berry, low growing, except strawberry,
                                                                                                     subgroup 13–07H at 0.02 ppm; Fruit,                   seq.), do not apply.
                                             subgroup 1C tolerance level.
                                                The tolerance level is appropriate                   citrus, group 10–10 at 0.01 ppm; Fruit,                  This action directly regulates growers,
                                             based on available data and residues                    pome, group 11–10 at 0.01 ppm; Fruit,                 food processors, food handlers, and food
                                             levels resulting from registered use                    small, vine climbing, except fuzzy                    retailers, not States or tribes, nor does
                                             patterns. The tolerance level for all                   kiwifruit, subgroup 13–07F at 0.01 ppm;               this action alter the relationships or
                                             subgroup 1C commodities is not                          Fruit, stone, group 12–12 at 0.01 ppm;                distribution of power and
                                             discriminatory; the same food safety                    Nut, tree, group 14–12 at 0.01 ppm;                   responsibilities established by Congress
                                             standard contained in the FFDCA                         Vegetable, tuberous and corm, subgroup                in the preemption provisions of FFDCA
                                             applies equally to domestically                         1C at 0.10 ppm; and tolerances with                   section 408(n)(4). As such, the Agency
                                             produced and imported foods. None of                    regional restriction on Fescue, forage at             has determined that this action will not
                                             the other tolerance actions taken in this               0.01 ppm; Fescue, hay at 0.01 ppm;                    have a substantial direct effect on States
                                             rulemaking restrict permissible                         Ryegrass, perennial, forage at 0.01 ppm;              or tribal governments, on the
                                             pesticide residues below currently                      and Ryegrass, perennial, hay at 0.01                  relationship between the national
                                             allowed levels in the United States.                    ppm. In addition, the Agency is                       government and the States or tribal
                                                Any commodities listed in the                        removing the existing tolerances for                  governments, or on the distribution of
                                             regulatory text of this document that are               ‘‘fruit, citrus, group 10’’, ‘‘fruit, pome,           power and responsibilities among the
                                             treated with the pesticides subject to                  group 11’’, ‘‘fruit, pome, group 12’’,                various levels of government or between
                                             this final rule, and that are in the                    ‘‘grape’’, ‘‘nut, tree, group 14’’, and               the Federal Government and Indian
                                             channels of trade following the                         ‘‘pistachio’’ since they are superseded               tribes. Thus, the Agency has determined
                                             tolerance revocation, shall be subject to               by the tolerances being established in                that Executive Order 13132, entitled
                                             FFDCA section 408(1)(5), as established                 this action. Finally, the Agency is                   ‘‘Federalism’’ (64 FR 43255, August 10,
                                             by FQPA. Under this unit, any residues                  establishing a six-month expiration date              1999) and Executive Order 13175,
                                             of these pesticides in or on such food                  for the existing ‘‘potato’’ tolerance at 0.1          entitled ‘‘Consultation and Coordination
                                             shall not render the food adulterated so                ppm.                                                  with Indian Tribal Governments’’ (65 FR
                                             long as it is shown to the satisfaction of                                                                    67249, November 9, 2000) do not apply
                                                                                                     VI. Statutory and Executive Order                     to this action. In addition, this action
                                             the Food and Drug Administration that:                  Reviews
                                                1. The residue is present as the result                                                                    does not impose any enforceable duty or
                                             of an application or use of the pesticide                 This action establishes tolerances                  contain any unfunded mandate as
                                             at a time and in a manner that was                      under FFDCA section 408(d) in                         described under Title II of the Unfunded
                                             lawful under FIFRA.                                     response to a petition submitted to the               Mandates Reform Act (UMRA) (2 U.S.C.
                                                2. The residue does not exceed the                   Agency. The Office of Management and                  1501 et seq.).
                                             level that was authorized at the time of                Budget (OMB) has exempted these types                    This action does not involve any
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                                             the application or use to be present on                 of actions from review under Executive                technical standards that would require
                                             the food under a tolerance or exemption                 Order 12866, entitled ‘‘Regulatory                    Agency consideration of voluntary
                                             from tolerance. Evidence to show that                   Planning and Review’’ (58 FR 51735,                   consensus standards pursuant to section
                                             food was lawfully treated may include                   October 4, 1993). Because this action                 12(d) of the National Technology
                                             records that verify the dates that the                  has been exempted from review under                   Transfer and Advancement Act
                                             pesticide was applied to such food.                     Executive Order 12866, this action is                 (NTTAA) (15 U.S.C. 272 note).


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                                                                      Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Rules and Regulations                                                                                                  5947

                                             VII. Congressional Review Act                                                  Dated: January 22, 2018.                                                   growing, except strawberry, subgroup
                                                                                                                          Michael L. Goodis,                                                           13–07H’’; ‘‘Fruit, citrus, group 10–10’’;
                                               Pursuant to the Congressional Review                                       Director, Registration Division, Office of                                   ‘‘Fruit, pome, group 11–10’’; ‘‘Fruit,
                                             Act (5 U.S.C. 801 et seq.), EPA will                                         Pesticide Programs.                                                          small, vine climbing, except fuzzy
                                             submit a report containing this rule and                                       Therefore, 40 CFR chapter I is                                             kiwifruit, subgroup 13–07F’’; ‘‘Fruit,
                                             other required information to the U.S.                                       amended as follows:                                                          stone, group 12–12’’; and ‘‘Nut, tree,
                                             Senate, the U.S. House of                                                                                                                                 group 14–12’’.
                                             Representatives, and the Comptroller                                         PART 180—[AMENDED]                                                           ■ iii. Revise the entry for ‘‘Potato’’ in the
                                             General of the United States prior to                                                                                                                     table in paragraph (a).
                                             publication of the rule in the Federal                                       ■ 1. The authority citation for part 180                                     ■ iv. Add alphabetically the entry to the
                                             Register. This action is not a ‘‘major                                       continues to read as follows:                                                table in paragraph (a) ‘‘Vegetable,
                                             rule’’ as defined by 5 U.S.C. 804(2).                                            Authority: 21 U.S.C. 321(q), 346a and 371.                               tuberous and corm, subgroup 1C’’.
                                                                                                                                                                                                       ■ v. Add footnote 1 to the table in
                                             List of Subjects in 40 CFR Part 180                                          ■  2. In § 180.478:                                                          paragraph (a).
                                                                                                                          ■  i. Remove the entries for ‘‘Fruit, citrus                                 ■ vi. Revise paragraph (c).
                                               Environmental protection,
                                                                                                                          group 10’’; ‘‘Fruit, pome, group 11’’;                                          The additions and revisions read as
                                             Administrative practice and procedure,
                                                                                                                          ‘‘Fruit, stone, group 12’’; ‘‘Grape’’; ‘‘Nut,                                follows:
                                             Agricultural commodities, Pesticides
                                                                                                                          tree, group 14’’; and ‘‘Pistachio’’ from
                                             and pests, Reporting and recordkeeping                                       the table in paragraph (a).                                                  § 180.478 Rimsulfuron; tolerances for
                                             requirements.                                                                ■ ii. Add alphabetically the entries to                                      residues.
                                                                                                                          the table in paragraph (a) ‘‘Berry, low                                          (a) * * *

                                                                                                                                                                                                                                                         Parts per
                                                                                                                                        Commodity                                                                                                         million


                                                       *                    *                  *                           *                                 *                                *                                                           *
                                             Berry, low growing, except strawberry, subgroup 13–07H .................................................................................................................                                           0.02

                                                           *                    *                                 *                                 *                                 *                                *                                  *
                                             Fruit,   citrus, group 10–10 ....................................................................................................................................................................                  0.01
                                             Fruit,   pome, group 11–10 ....................................................................................................................................................................                    0.01
                                             Fruit,   small, vine climbing, except fuzzy kiwifruit, subgroup 13–07F ..................................................................................................                                          0.01
                                             Fruit,   stone, group 12–12 ....................................................................................................................................................................                   0.01

                                                       *                      *                                 *                                 *                                 *                                *                                    *
                                             Nut, tree, group 14–12 ........................................................................................................................................................................                    0.01

                                                      *                                 *                                 *                                 *                                 *                                *                          *
                                             Potato 1 ................................................................................................................................................................................................           0.1

                                                     *                   *                      *                                 *                                 *                                *                                                    *
                                             Vegetable, tuberous and corm, subgroup 1C .....................................................................................................................................                                    0.10
                                                 1 This   tolerance expires on August 12, 2018.


                                             *     *     *     *     *                                                    herbicide rimsulfuron, including its                                         determined by measuring only
                                               (c) Tolerances with regional                                               metabolites and degradates, in or on the                                     rimsulfuron, N-[[(4,6-dimethoxy-2-
                                             registrations. Tolerances with regional                                      commodities in the following table.                                          pyrimidinyl)amino] carbonyl]-3-
                                             registrations, as defined in § 180.1(1),                                     Compliance with the tolerance levels                                         (ethylsulfonyl)-2-pyridinesulfonamide.
                                             are established for residues of the                                          specific in the following table is to be

                                                                                                                                                                                                                                                         Parts per
                                                                                                                                        Commodity                                                                                                         million

                                             Fescue, forage .....................................................................................................................................................................................               0.01
                                             Fescue, hay .........................................................................................................................................................................................              0.01
                                             Ryegrass, perennial, forage ................................................................................................................................................................                       0.01
                                             Ryegrass, perennial, hay .....................................................................................................................................................................                     0.01



                                             *        *         *         *         *
                                             [FR Doc. 2018–02676 Filed 2–9–18; 8:45 am]
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                                             BILLING CODE 6560–50–P




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Document Created: 2018-11-01 08:42:03
Document Modified: 2018-11-01 08:42:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective February 12, 2018. Objections and requests for hearings must be received on or before April 13, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactMichael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
FR Citation83 FR 5942 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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