[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Rules and Regulations]
[Pages 53326-53331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21539]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0779; FRL-9996-14]


Thiamethoxam; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of thiamethoxam in or on rice. 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 the pesticide 
on rice. This regulation establishes a maximum permissible level for 
residues of thiamethoxam in or on these commodities. The time-limited 
tolerances expire on December 31, 2024. This action is also associated 
with the utilization of a crisis exemption under the FIFRA authorizing 
use of the pesticide 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-2018-0779, 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: 

[[Page 53327]]

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 Printing 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 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-
2018-0779 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-2018-0779, 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 time-limited tolerances for residues of thiamethoxam, 3-
[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine, in or on rice, grain at 6 parts per million (ppm) 
and rice, straw at 2 ppm. These time-limited tolerances expire 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

    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.

[[Page 53328]]

    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of thiamethoxam 
in or on rice. 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 these time-
limited tolerances expire 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.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
thiamethoxam meets FIFRA's registration requirements for use on rice or 
whether permanent tolerances for this use would be appropriate. Under 
these circumstances, EPA does not believe that this time-limited 
tolerance decision serves as a basis for registration of thiamethoxam 
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 this pesticide 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 thiamethoxam, 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 and 
the time-limited tolerances for residues of thiamethoxam on rice, grain 
at 6 ppm rice, straw at 2 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 thiamethoxam used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of February 15, 2017 (82 FR 10714) 
(FRL-9957-00).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to thiamethoxam, EPA considered exposure under the time-
limited tolerances established by this action as well as all existing 
thiamethoxam tolerances in 40 CFR 180.565. EPA assessed dietary 
exposures from thiamethoxam in food as follows:
    i. Acute exposure. Acute effects were identified for thiamethoxam. 
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 100 percent crop treated.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's 2003-2008 
NHANES/WWEIA). As to residue levels in food, EPA assumed field-trial 
average residues and 100 percent crop treated (PCT).
    iii. Cancer. Based on the data summarized in Unit IV.A., EPA has 
concluded that thiamethoxam 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 thiamethoxam. 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 thiamethoxam in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of thiamethoxam. 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 Flooded Applications Model (PFAM) or 
Tier 1 Rice Model and Pesticide in Water Calculator (PWC)), the 
estimated drinking water concentrations (EDWCs) of thiamethoxam for 
acute exposures are estimated to be 20 ppb parts per billion (ppb) for 
surface water and 63 ppb for ground water.
    For chronic exposures for non-cancer assessments EDWCs are 
estimated to be 1.05 ppb for surface water and 58 ppb for ground 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 63 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 58 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in

[[Page 53329]]

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).
    Thiamethoxam is currently registered for the following uses that 
could result in residential exposures: Turfgrass (including golf 
courses, residential lawns, and athletic fields), residential 
landscapes, structural/perimeter applications (indoors and outdoors in 
schools, apartments, etc.), and indoor control of bed bugs. EPA 
assessed residential exposure using the following assumptions: Short-
term exposures, lasting from 1 to 30 days, may occur from uses of 
thiamethoxam in residential settings. These exposures may occur by 
dermal, inhalation, and incidental oral (children <6 years old) routes.
    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.
    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 thiamethoxam to share a common mechanism of 
toxicity with any other substances, and thiamethoxam does not appear to 
produce a toxic metabolite produced by other substances. Thiamethoxam 
and its clothianidin metabolite have different mechanisms of toxicity 
in mammals, and since clothianidin has a complete database owing to its 
registration as a pesticide active ingredient, it is appropriate for 
EPA to evaluate its risks separately. For the purposes of this 
tolerance action, therefore, EPA has assumed that thiamethoxam 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. In mammals, toxicological 
effects are seen primarily in the liver, kidney, testes, and blood 
cellular (hematopoietic) system. In addition, developmental 
neurological effects were observed in rats. These developmental effects 
were used to assess risk associated with acute exposure to 
thiamethoxam, and the liver and testicular effects are the basis for 
assessing longer-term exposures. The PODs used for risk assessment are 
protective of all effects, including quantitative susceptibility 
observed in developmental and reproduction studies, and the exposure 
assessments do not underestimate exposures.
    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 thiamethoxam is complete.
    ii. Evidence of neurotoxicity was seen in the acute and DNT studies 
in the rat. However, there is a low degree of concern for the potential 
neurotoxic effects of thiamethoxam since: (1) Clear NOAELs were 
identified for the neurotoxic effects; (2) the neurotoxic effects were 
not the most sensitive endpoint in the toxicity database; and (3) the 
endpoints chosen for risk assessment are protective of any potential 
neurotoxicity.
    iii. There is no evidence that thiamethoxam 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. There was no evidence of increased quantitative susceptibility 
in the core guideline toxicity studies. The maternal/parental NOAELs/
LOAELs in the 1998 two-generation reproduction toxicity study and the 
core developmental toxicity studies (rats and rabbits) occur at doses 
lower than or equal to the developmental/offspring NOAELs/LOAELs and 
are, therefore, not indicative of a quantitative susceptibility. 
Furthermore, the severity of effects in the parent and fetus/offspring 
generations in the three studies are comparable and therefore are not 
indicative of qualitative sensitivity. However, in the DNT and the 2004 
2-generation reproduction toxicity studies in rats, developmental/
offspring effects were seen in the absence of maternal toxicity; 
therefore, there is evidence of quantitative susceptibility. In the 
2004 two-generation rat reproduction study, decreased total litter 
weights were observed in pups in the absence of parental adverse 
effects. In the rat DNT study, decreased body weight and body weight 
gain, as well as reduced brain weight and size were observed in the 
pups in the absence of adverse effects in dams. However, considering 
the overall toxicity profile and the doses and endpoints selected for 
risk assessment, the degree of concern for the effects observed in the 
studies is low because (1) the developmental/offspring effects observed 
in the studies are well characterized and (2) clear NOAELs/LOAELs have 
been identified in the studies for the effects of concern. 
Additionally, the Agency is confident that the endpoints and PODs 
selected for risk assessment are protective of potential developmental/
reproductive effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. There are no residual uncertainties with respect to dietary 
or residential exposure. The dietary exposure assessments are based on 
high-end residue levels from crop field trials and empirical and 
default processing factors, both of which account for parent and 
metabolites of concern, and the assumption of 100 PCT for all 
agricultural commodities. Furthermore, conservative, upper-bound 
assumptions were used to determine exposure through drinking water, 
such that these exposures have not been underestimated. Therefore, the 
actual risk from exposure to thiamethoxam will likely be much lower 
than calculated risk estimates. In addition, the residential exposure 
estimates are conservative and do not underestimate exposure and risk. 
EPA made conservative (protective) assumptions in the ground and 
surface water modeling used to assess exposure to thiamethoxam in 
drinking water. EPA used similarly conservative assumptions to assess 
post-application exposure of youth and children as well as incidental 
oral exposure of children 1 to 2 years old (1 < 2). These assessments 
will not

[[Page 53330]]

underestimate the exposure and risks posed by thiamethoxam.

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 thiamethoxam will occupy 12% of the aPAD for children 1 to 2 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
thiamethoxam from food and water will utilize 74% of the cPAD for 
(children 1 to 2 years old) the population group receiving the greatest 
exposure.
    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).
    Thiamethoxam 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 thiamethoxam.
    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 ranging from 130 for 
adults to 330 for children less than 6 years old. Because EPA's level 
of concern for thiamethoxam 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, thiamethoxam 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, thiamethoxam 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 thiamethoxam 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 
tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    Neither the Codex nor Canada has established specific MRLs for 
thiamethoxam residues in rice commodities. Canada has established an 
``All food crops'' MRL at 0.02 ppm for thiamethoxam that would apply to 
rice, but it is not specific to a use on rice.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine, in or on rice, grain at 6 ppm and 
rice, straw at 2 ppm. These tolerances expire 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

[[Page 53331]]

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.

    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.  180.565, revise paragraph (b) to read as follows:


Sec.  180.565   Thiamethoxam; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the table are established for residues of the insecticide 
thiamethoxam, including its metabolites and degradates. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only thiamethoxam 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-
N-nitro-4H-1,3,5-oxadiazin-4-imine and its metabolite CGA-322704 N-[(2-
chloro-thiazol-5-yl)methyl]-N'-methyl-N''-nitro-guanidine, calculated 
as the stoichiometric equivalent of thiamethoxam, in or on the 
specified agricultural commodities, resulting from use of the pesticide 
pursuant to FFIFRA section 18 emergency exemptions. The tolerances 
expire on the date specified in the table.

------------------------------------------------------------------------
                                               Parts per    Expiration
                  Commodity                     million        date
------------------------------------------------------------------------
Rice, grain.................................           6      12/31/2024
Rice, straw.................................           2      12/31/2024
------------------------------------------------------------------------

* * * * *

[FR Doc. 2019-21539 Filed 10-4-19; 8:45 am]
 BILLING CODE 6560-50-P


