[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Rules and Regulations]
[Pages 5942-5947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02676]


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

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.

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

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established tolerances that are superseded by this final rule.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.

[[Page 5944]]



                    Table 1--Summary of Toxicological Doses and Endpoints for Rimsulfuron for
                                       Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
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/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.
----------------------------------------------------------------------------------------------------------------
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

[[Page 5945]]

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


