Document ID: EPA-HQ-OPP-2019-0141-0001
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Clothianidin; Emergency Exemptions
Posted Date: 2019-10-07T04:00Z

[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Rules and Regulations]
[Pages 53331-53336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21540]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0141; FRL-9996-15]

Clothianidin; Pesticide Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of clothianidin in or on rice, grain. This action is in 
response to EPA's granting of an emergency exemption under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of 
thiamethoxam on rice. Emergency use of thiamethoxam on rice results in 
potential clothianidin (a major metabolite of thiamethoxam) residues 
that when combined with the residues from legal use of clothianidin on 
rice, require an increase in the tolerance for residues of clothianidin 
in rice. Although there is an existing regulation establishing a 
maximum permissible level for residues of clothianidin in or on rice, 
grain at 0.01 ppm, this rule would establish a new, time-limited 
maximum permissible level at 0.5 ppm for clothianidin in or on rice, 
grain. The time-limited tolerance expires on December 31, 2024. This 
action is also associated with the utilization of a crisis exemption 
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of thiamethoxam on rice.

DATES: This regulation is effective October 7, 2019. Objections and 
requests for hearings must be received on or before December 6, 2019 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2019-0141, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Publishing Office's e-CFR site at 
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp. and select 
``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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

[[Page 53332]]

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-2019-0141 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 December 
6, 2019. Addresses for mail and hand delivery of objections and hearing 
requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2019-0141, 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing a time-limited tolerance for residues of clothianidin, 
(E)-N-[(2-chloro-5-thiazolyl)methyl]-N ' -methyl-N '' -nitroguanidine, 
in or on rice, grain at 0.5 parts per million (ppm). This time-limited 
tolerance expires on December 31, 2024.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    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 . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Thiamethoxam on Rice and FFDCA Tolerances 
for Clothianidin Residues

    During 2015, the first year the rice delphacid pest appeared in 
Texas, the Texas Department of Agriculture (TDA) reported ratoon rice 
losses as high as 25%. TDA claims that they are experiencing high 
numbers of rice delphacid in ratoon rice and recently, pest populations 
over 8,000 nymphs and adult rice delphacids per 10 sweeps were observed 
in a rice field in Galveston county. Approximately 60% of Texas' rice 
crop is ratooned and in 2018, this represented more than 100,000 acres. 
There are no insecticides labeled specifically for rice delphacid, and 
TDA says that products registered for leafhopper control in rice are 
not efficacious in controlling rice delphacid. On October 31, 2018, the 
TDA issued a crisis exemption for use of thiamethoxam on rice. The 
crisis exemption expired on November 9, 2018. Due to the short duration 
of the crisis exemption, the pest was not fully controlled and 
therefore, TDA submitted a quarantine request for this use pattern.
    After having reviewed the submission, EPA determined that an 
emergency condition existed in this State, and that the criteria for 
approval of an emergency exemption were met. On March 3, 2019, EPA 
authorized a quarantine exemption under FIFRA section 18 for the use of 
thiamethoxam on rice for control of rice delphacid in Texas. EPA is 
establishing a time-limited tolerance for thiamethoxam on rice through 
a separate rulemaking. The emergency use of thiamethoxam in rice can 
potentially result in residues of clothianidin (a major metabolite of 
thiamethoxam) which might exceed the existing tolerance level of 0.01 
ppm clothianidin in rice. Therefore, a time-limited tolerance for 
residues of clothianidin in rice, grain is being established. As part 
of its evaluation of the emergency exemption application for 
thiamethoxam, EPA assessed the potential risks presented by residues of 
clothianidin in or on rice, since clothianidin is a major metabolite of 
thiamethoxam. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerances under 
FFDCA section 408(l)(6) would be consistent with the safety standard 
and with FIFRA section 18. Consistent with the need to move quickly on 
the emergency exemption in order to address an urgent, non-routine 
situation and to ensure that the resulting food is safe and lawful, EPA 
is issuing these tolerances without notice and opportunity for public 
comment as provided in FFDCA section 408(l)(6). Although this time-
limited tolerance expires on December 31, 2024, under FFDCA section 
408(l)(5), residues of the pesticide not in excess of the amounts 
specified in the tolerance remaining in or on rice after that date will 
not be unlawful, provided the pesticide was applied in a manner that 
was lawful under FIFRA, and the residues do not exceed a level that was 
authorized by these time-limited tolerances at the time of that 
application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe. This time-limited tolerance increase is being approved to

[[Page 53333]]

address the potential increase in clothianidin residues from the use of 
thiamethoxam under emergency conditions. The clothianidin risk 
assessment appears in the February 6, 2019 memorandum titled 
``Thiamethoxam. 19TX02 and 19TX03. Human Health Risk Assessment for 
Section 18 Emergency Exemption Use on Rice in Texas.'' Under these 
circumstances, EPA does not believe that this time-limited tolerance 
decision serves as a basis for registration of clothianidin by a State 
for special local needs under FIFRA section 24(c), nor does this 
tolerance by itself serve as the authority for persons in any State 
other than Texas to use clothianidin on the applicable crops under 
FIFRA section 18, absent the issuance of an emergency exemption 
applicable within that State. For additional information regarding the 
emergency exemption for clothianidin, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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 expected as a result of this emergency exemption request for 
thiamethoxam, and the time-limited tolerances for residues of 
clothianidin on rice, grain at 0.5 ppm. EPA's assessment of exposures 
and risks associated with establishing time-limited tolerances follows.

A. 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    A summary of the toxicological endpoints for clothianidin used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of August 29, 2012 (77 FR 52248) 
(FRL-9360-4).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to clothianidin, EPA considered exposure from application of 
thiamethoxam under the time-limited tolerances established by this 
action as well as all existing clothianidin tolerances in 40 CFR 
180.586. EPA assessed dietary exposures from clothianidin in food as 
follows:
    i. Acute exposure. Acute effects were identified for clothianidin. 
In estimating acute dietary exposure, EPA used food consumption 
information 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 
tolerance-level residues and that 100% of the commodities in the 
assessment were treated (100 PCT) with both clothianidin and 
thiamethoxam.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). As to residue levels in food, EPA assumed 
field-trial average residues and that 100% of the commodities in the 
assessment were treated (100 PCT) with both clothianidin and 
thiamethoxam.
    iii. Cancer. Based on the data summarized in Unit IV.A., EPA has 
concluded that clothianidin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for clothianidin. Tolerance level residues and 100% 
CT were assumed for all food commodities with both clothianidin and 
thiamethoxam.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for clothianidin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of clothianidin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticides in Water Calculator and Tier 1 Rice Model, 
the estimated drinking water concentrations (EDWCs) of clothianidin for 
acute exposures are estimated to be 67 parts per billion (ppb) for 
surface water and 180 ppb for ground water. For chronic exposures for 
non-cancer assessments are estimated to be 67 ppb for surface water and 
139 ppb for ground water. This is based on use of clothianidin as a 
pesticide active ingredient and does not include clothianidin as a 
thiamethoxam metabolite, because when thiamethoxam is applied to crops, 
the clothianidin metabolite is not a major residue in drinking water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 180 ppb was used to assess 
the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration value 
of 139 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).
    Clothianidin is currently registered for the following uses that 
could result in residential exposures: Turf, ornamental plants and 
indoor surfaces. EPA assessed residential exposure using the following 
assumptions: Short-term handler (adults) and post-application exposures 
(adults and children) may occur in accordance with existing uses.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

[[Page 53334]]

    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found clothianidin to share a common mechanism of 
toxicity with any other substances, and clothianidin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
clothianidin does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is no residual concern 
for increased qualitative or quantitative susceptibility in the rat or 
rabbit developmental toxicity studies; however, there was increased 
quantitative susceptibility in the two-generation reproduction and 
developmental neurotoxicity studies in the rat, as the offspring NOAELs 
were below the parental NOAELs. Clear NOAELs were identified for the 
offspring effects in these rat studies. There were indications of 
potential immunotoxicity in the database. Decreased absolute and 
relative thymus and spleen weights were observed in multiple studies. 
Juvenile rats in the two-generation reproduction study appeared to be 
more susceptible to these effects, indicating a concern for qualitative 
susceptibility. However, a guideline immunotoxicity study showed no 
evidence of clothianidin-mediated immunotoxicity in adult rats, and a 
developmental immunotoxicity study demonstrated no susceptibility with 
respect to offspring immunotoxicity. Therefore, the residual concern 
for immunotoxicity in adults and offspring is reduced. Since there is 
evidence of increased quantitative susceptibility of the young 
following exposure to clothianidin in the rat reproduction study and 
the rat developmental neurotoxicity study (DNT), the Agency performed a 
degree of concern analysis to: (1) Determine the level of concern for 
the effects observed when considered in the context of all available 
toxicity data; and, (2) identify any residual uncertainties after 
establishing toxicity endpoints and traditional uncertainty factors to 
be used in the clothianidin risk assessment. If residual uncertainties 
are identified, the Agency examines whether the residual uncertainties 
can be addressed by a FQPA safety factor, and if so, what factors 
should be retained. Considering the overall toxicity profile and the 
endpoints and doses selected for the clothianidin risk assessment, the 
Agency characterized the degree of concern for the effects observed in 
the clothianidin two-generation reproduction and DNT studies as low 
because: (1) There are clear NOAELs for the offspring effects and 
regulatory doses were selected to be protective against these effects; 
(2) no other residual uncertainties were identified with respect to 
susceptibility of infants and children; and (3) the endpoints and doses 
selected for clothianidin are protective against adverse effects in 
both offspring and adults.
    3. Conclusion. EPA has determined that reliable data show that 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 clothianidin is complete, and includes 
developmental neurotoxicity, adult immunotoxicity and developmental 
immunotoxicity studies.
    ii. The degree of concern for the quantitative susceptibility 
observed in the clothianidin two-generation reproduction and DNT 
studies is low based on the clear NOAELs for the offspring effects and 
the selection of regulatory doses that are protective of those effects.
    iii. The rat is the most sensitive species tested, and the NOAEL 
and LOAEL selected from the two-generation reproduction study in rats 
are protective of effects observed in other species throughout the 
toxicology database.
    iv. There are no residual uncertainties for pre- and/or post-natal 
toxicity.
    v. The Agency is regulating the use of clothianidin based upon the 
most sensitive offspring effects observed in the reproduction toxicity 
study, and therefore the risk assessment is protective of these and 
other effects that occurred at higher doses.
    vi. The exposure databases (dietary food, drinking water, and 
residential) are complete.
    vii. The risk assessment for each potential exposure scenario 
includes all metabolites and/or degradates of concern and does not 
underestimate potential exposure and risk for infants or children. EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to clothianidin in drinking 
water. EPA used similarly conservative assumptions to assess post 
application exposure of children as well as incidental oral exposure of 
toddlers. These assessments will not underestimate the exposure and 
risks posed by clothianidin.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to clothianidin will occupy 19% of the aPAD for infants less than 1-
year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
clothianidin from food and water will utilize 9% of the cPAD for 
(infants less than 1-year old), the population group receiving the 
greatest exposure. Based on the explanation in the unit regarding 
residential use patterns, chronic residential exposure to residues of 
clothianidin is not expected.

[[Page 53335]]

    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Clothianidin is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to clothianidin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 390 for adults 
and 150 for children. Because EPA's level of concern for clothianidin 
is an MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). Because no intermediate-term adverse effect 
was identified, clothianidin is not expected to pose an intermediate-
term risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, clothianidin is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to clothianidin residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate method using liquid solvent extraction, solvent and 
solid-phase extraction clean-up, and high-performance liquid 
chromatography (HPLC) Method AG-675, is available to enforce the 
tolerances.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The time-limited tolerance of 0.5 ppm in or on rice, grain is 
consistent with the existing Codex MRL of 0.5 ppm. EPA is recommending 
that the tolerance level of 0.4 ppm suggested by the OECD Calculation 
Procedures be raised to 0.5 ppm to harmonize with the Codex MRL. The 
Agency notes that the compliance residue definitions for the US, 
Canada, and Codex are harmonized; all specify only clothianidin.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
clothianidin, (E)-N-[(2-chloro-5-thiazolyl)methyl]-N[hairsp]' -methyl-
N[hairsp]'' -nitroguanidine, in or on rice, grain at 0.5 ppm. This 
tolerance expires on December 31, 2024.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and 
408(l)(6). The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). 
Because this action has been exempted from review under Executive Order 
12866, this action is not subject to Executive Order 13211, entitled 
``Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive 
Order 13045, entitled ``Protection of Children from Environmental 
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This 
action does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., nor does it require any special considerations under Executive 
Order 12898, entitled ``Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations'' (59 FR 
7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance 
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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).

VIII. 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.

[[Page 53336]]

    Dated: September 19, 2019.
Michael 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.  180.586, add alphabetically the entry ``Rice, grain'' to 
the table in paragraph (b) to read as follows:

Sec.  180.586  Clothianidin; tolerances for residues.

* * * * *

------------------------------------------------------------------------
                                             Parts per      Expiration
                Commodity                     million          date
------------------------------------------------------------------------
 
                              * * * * * * *
Rice, grain.............................             0.5      12/31/2024
------------------------------------------------------------------------

* * * * *

[FR Doc. 2019-21540 Filed 10-4-19; 8:45 am]
 BILLING CODE 6560-50-P