[Federal Register Volume 84, Number 125 (Friday, June 28, 2019)]
[Rules and Regulations]
[Pages 30933-30939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13546]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0493; FRL-9985-41]


Ethiprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
insecticide ethiprole in or on coffee, green bean. Bayer CropScience LP 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective June 28, 2019. Objections and 
requests for

[[Page 30934]]

hearings must be received on or before August 27, 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-2009-0493, 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, P.E., Director, 
Registration Division (750P), 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-2009-0493 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 
August 27, 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-2009-0493, 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 October 24, 2018 (83 FR 53594) (FRL-
9983-46), 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 
7E8586) by Bayer CropScience LP, P.O. Box 12014, 2 T.W. Alexander Dr., 
Research Triangle Park, NC 27709-2014. The petition requested that 40 
CFR 180.652 be amended by establishing tolerances for residues of the 
insecticide ethiprole, 5-amino-1-[2,6-dichloro-4-
(trifluoromethyl)phenyl]-4-(ethylsulfinyl)-1H-pyrazole-3-carbonitrile, 
in or on coffee (green beans) and roasted coffee and instant coffee at 
0.1 parts per million (ppm). That document referenced a summary of the 
petition prepared by Bayer CropScience LP, the registrant, which is 
available in the docket, http://www.regulations.gov. These tolerances 
were requested to cover residues of ethiprole in or on coffee resulting 
from uses of this pesticide on coffee outside the United States. There 
is no current U.S. registration for use of ethiprole on coffee. The 
only comment submitted to this docket supported this rulemaking.
    Based upon review of the data supporting the petition, EPA has 
concluded that tolerances are not needed for the processed coffee 
commodities since available data demonstrate that residues of ethiprole 
did not concentrate in these processed commodities.

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 ethiprole including exposure 
resulting from the tolerances established by this action.

[[Page 30935]]

EPA's assessment of exposures and risks associated with ethiprole 
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.
    Ethiprole has a low acute toxicity via the oral, dermal, and 
inhalation routes of exposure, and is not a skin sensitizer nor a skin 
or eye irritant. In the mammalian toxicology database, the critical 
effects of ethiprole are liver toxicity and thyroid toxicity. The rat 
was the most sensitive species overall after administration of 
ethiprole. Evidence of hepatotoxicity is seen in the rat, dog, and 
mouse and was manifested as increased liver weight and hepatocellular 
hypertrophy and changes in clinical chemistry such as increased alanine 
transaminase and alkaline phosphates activities; increased cholesterol 
and triglycerides levels; and increased total protein concentration. 
Thyroid toxicity was observed in the rat and was manifested as 
increased thyroid weight, thyroid follicular hypertrophy along with 
higher TSH plasma levels, and reduced T4 (thyroxine) plasma levels. 
Mechanism studies of thyroid toxicity suggested that ethiprole acts by 
disrupting thyroid hormone homeostasis and indirectly influences the 
thyroid by inducing the hepatic microsomal enzyme T4- glucuronyl 
transferase.
    Ethiprole is neither a reproductive nor a developmental toxicant. 
Although no teratogenic effects were observed in the existing database, 
there is uncertainty regarding the potential impact of ethiprole on 
thyroid hormone homeostasis in the developing organism.
    In the acute neurotoxicity study, clinical signs showed consistent 
effects that might be anticipated for a chemical interacting with 
neurotransmitter chloride channels, including low arousal levels, 
increased eye closure, increased incidence of body tremors, and 
decreased rearing counts in females at the mid dose. However, no 
neurotoxicity effects were noted in the subchronic neurotoxicity study 
up to and including the highest dose of 400 ppm (33.0 mg/kg/day). There 
were no effects on neuropathology in any of the studies.
    Based on a battery of mutagenicity studies, ethiprole is not 
considered to be genotoxic. In accordance with the EPA's Final 
Guidelines for Carcinogen Risk Assessment (March 2005), ethiprole is 
classified as ``Suggestive Evidence of Carcinogenicity, but Not 
Sufficient to Assess Human Carcinogenicity Potential'' based on 
increased incidences of hepatocellular adenomas in females at the 
highest dose tested in the carcinogenicity study in mice. While the 
evidence from animal data is suggestive of carcinogenicity, a cancer 
risk to humans from dietary exposure to ethiprole is of low concern, 
and a nonlinear approach is appropriate for assessing potential cancer 
risk based on the following weight-of-evidence considerations:
    1. The liver tumors in mice were benign with no progression to 
malignancy;
    2. The thyroid tumors in rats were also benign (with no progression 
to malignancy), and the increase in the tumor incidences at the high 
dose did not reach statistical significance when compared to controls;
    3. In both species (mice and rats), tumors were observed only at 
the high dose level (i.e., there was a lack of evidence of a dose-
response relationship);
    4. There is no concern for mutagenicity/genotoxicity;
    5. The no-observed-adverse-effect level (NOAEL) of 0.85 milligrams/
kilograms/day (mg/kg/day) used for deriving the cRfD is approximately 
86-fold lower than the dose (73 mg/kg/day) that induced benign tumors 
in mice; and
    6. The reduction of the Food Quality Protection Act Safety Factor 
(FQPA SF) to 1x yields a chronic Population Adjusted Dose (cPAD) of 
0.03 mg/kg/day. The Agency has determined that the cPAD will adequately 
account for all chronic effects, including carcinogenicity, likely to 
result from exposure to ethiprole.
    More detailed information on the studies received and the nature of 
the adverse effects caused by ethiprole as well as the NOAEL and the 
LOAEL from the toxicological studies can be found in the document 
entitled, ``Ethiprole: Human Health Risk Assessment for a Proposed 
Tolerance without U.S. Registration in/on Imported Coffee, Green 
Bean,'' dated April 29, 2019, by going to http://www.regulations.gov. 
The referenced document is available in the docket established by this 
action, which is described under ADDRESSES. Locate and click on the 
hyperlink for docket ID number EPA-HQ-OPP-2009-0493. Double-click on 
the document to view the referenced information.

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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for ethiprole used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 30936]]



   Table 1--Summary of Toxicological Doses and Endpoints for Ethiprole for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute Dietary (All populations)..  NOAEL = 35 mg/kg/day  Acute RfD = 0.35 mg/ Acute Neurotoxicity in Rats Study.
                                   UFA = 10x...........   kg/day.             LOAEL = 250 mg/kg/day based on
                                   UFH = 10x...........  aPAD = 0.35 mg/kg/    decreased locomotor activity and
                                   FQPA SF = 1x........   day.                 functional observational battery
                                   Combined UFs = 100x.                        (FOB) findings in both sexes on
                                                                               the day of treatment.
Chronic Dietary (All populations)  NOAEL = 0.85 mg/kg/   Chronic RfD = 0.03   Combined Chronic/Carcinogenicity
                                    day.                  mg/kg/day.           Oral (Dietary) Toxicity in Rats.
                                   UFA = 3x............  cPAD = 0.03 mg/kg/   LOAEL = 3.21/4.40 mg/kg/day M/F
                                   UFH = 10x...........   day.                 based on observed effects in the
                                   FQPA SF = 1x........                        thyroid and/or liver
                                   Combined UFs = 30x..                        (histopathologic changes,
                                                                               increased organ weights, and/or
                                                                               altered thyroid hormone or
                                                                               bilirubin levels).
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Cancer Dietary (Oral, Dermal,      Classification: ``Suggestive Evidence of Carcinogenicity, but Not Sufficient
 Inhalation).                       to Assess Human Carcinogenicity Potential'' Quantification using a cancer
                                    potency factor is not needed; a nonlinear approach based on the cRfD is
                                    protective of potential cancer risk.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. NOAEL = no-
  observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

    More detailed information on the toxicological endpoints for 
ethiprole can be found in the document entitled, ``Ethiprole: Human 
Health Risk Assessment for a Proposed Tolerance without U.S. 
Registration in/on Imported Coffee, Green Bean,'' dated April 29, 2019, 
by going to http://www.regulations.gov. The referenced document is 
available in the docket established by this action, which is described 
under ADDRESSES. Locate and click on the hyperlink for docket ID number 
EPA-HQ-OPP-2009-0493. Double-click on the document to view the 
referenced information.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to ethiprole, EPA considered exposure under the petitioned-for 
tolerances as well as all existing ethiprole tolerances in 40 CFR 
180.652 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. In estimating acute dietary 
(food and drinking water) exposure, EPA used food consumption 
information from the Dietary Exposure Evaluation Model--Food Commodity 
Intake Database (DEEM-FCIDTM, Version 3.18), which 
incorporates 2003-2008 consumption data from the United States 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). An 
unrefined, acute dietary exposure assessment was conducted assuming 
tolerance-level residues and assuming 100 percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used DEEM-FCIDTM, Version 3.18, which 
incorporates 2003-2008 consumption data from the USDA's NHANES/WWEIA. 
An unrefined chronic dietary risk analysis was conducted assuming 
tolerance-level residues and 100 PCT.
    iii. Cancer. As explained in unit III.A., quantification of risk 
using a non-linear approach (i.e., a cPAD) will adequately account for 
all chronic toxicity, including carcinogenicity, that could result from 
exposure to ethiprole. No separate exposure assessment pertaining to 
cancer risk was performed for ethiprole; rather, EPA relied on the 
chronic exposure assessment described in this Unit for assessing the 
risk of all chronic effects, including cancer.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue information in the dietary 
assessment for ethiprole. Tolerance-level residues and/or 100% CT were 
assumed for all food commodities.
    More detailed information on the acute and chronic dietary (food 
only) exposure and risk assessment for ethiprole can be found in the 
document entitled, ``Ethiprole: Human Health Risk Assessment for a 
Proposed Tolerance without U.S. Registration in/on Imported Coffee, 
Green Bean,'' dated April 29, 2019, by going to http://www.regulations.gov. The referenced document is available in the docket 
established by this action, which is described under ADDRESSES. Locate 
and click on the hyperlink for docket ID number EPA-HQ-OPP-2009-0493. 
Double-click on the document to view the referenced information.
    2. Dietary exposure from drinking water. Ethiprole and its 
degradates were not considered for drinking water assessment because 
ethiprole is not registered for use in the U.S.; therefore, exposure to 
residues of ethiprole in drinking water is not expected.
    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). Ethiprole is not 
registered for any specific use patterns that would result in 
residential exposure.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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

[[Page 30937]]

substances that have a common mechanism of toxicity.'' EPA has not made 
a common mechanism of toxicity finding as to ethiprole and any other 
substances, and ethiprole does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action; therefore, EPA has not assumed that ethiprole has 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 the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10x) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10x, or uses a different additional safety factor when 
reliable data are available to EPA support the choice of a different 
safety factor.
    2. Prenatal and postnatal sensitivity. Although no teratogenic 
effects were observed in the existing toxicology database, there is 
uncertainty regarding the potential impact of ethiprole on thyroid 
hormone homeostasis in the developing organism. Observations 
demonstrated that thyroid hormones were affected in several studies 
throughout the ethiprole database. Thyroid hormones may play a critical 
role in the development of the nervous system.
    3. Conclusion. EPA has determined that reliable hazard and exposure 
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 toxicology database for ethiprole is complete for 
establishing tolerances without U.S. registration purposes. Previously 
the Agency determined that a CTA is required based on the weight-of-
evidence. Subsequently, the registrant submitted a request for a CTA 
waiver. Based on a weight-of-evidence approach that considered the 
relatively low exposure to the highest exposed populations and the fact 
that had the 10x been retained, the exposure levels would still result 
in estimated risks below the levels of concern, the Agency concludes 
that a CTA in pregnant animals, fetuses, postnatal animals, and adult 
animals is not required for ethiprole at this time.
    ii. In mammals, no neurotoxic effects were observed during the 
subchronic neurotoxicity study in which adverse effects of increased 
thyroid and liver weights were observed in males and females, 
respectively. The acute neurotoxicity study showed decreased locomotor 
activity (both sexes, day 1) and the FOB findings in both sexes on the 
day of treatment (4 hours after dosing). The FOB findings included 
increased tremors (females), decreased grooming (both sexes), decreased 
arousal alert (females), increased number of animals for which no 
assessment of gait was possible (females), increased eye closure 
(females), increased standing/sitting hunched (females), decreased 
activity and rearing counts (females), increased hindlimb and forelimb 
grip strength (males), decreased splay (females, day 1), and increased 
splay (males, day 8). The similarity in the NOAELs from the acute 
neurotoxicity and subchronic neurotoxicity studies are consistent with 
the metabolism data that suggesting that ethiprole is not accumulated 
in the system. Therefore, a developmental neurotoxicity (DNT) study is 
not required for ethiprole.
    iii. There is no evidence that ethiprole 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 
database for ethiprole. The dietary assessment is based on high end 
assumptions, assuming tolerance-level residues and 100 PCT. The 
assessment will not underestimate the exposure and risk posed by 
ethiprole.

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). Since there are no registered 
or proposed uses of ethiprole that result in residential exposure, the 
acute and chronic aggregate exposure and risk assessments are equal to 
the acute and chronic dietary exposure and risk estimates (food only), 
respectively. 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. Using the exposure assumptions described in this Unit 
for dietary and non-dietary acute exposures, EPA has concluded that 
acute dietary exposure to ethiprole from food only will utilize <1% of 
the aPAD for the general U.S. population. The most highly-exposed 
population subgroup, all infants (<1 year old), utilized 2.1% of the 
aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
Unit for chronic exposure, EPA has concluded that chronic dietary 
exposure to ethiprole from food only will utilize 2.0% of the cPAD for 
the general U.S. population. The most highly-exposed population 
subgroup, all infants (<1 year old), utilized 5.7% of the cPAD. Based 
on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of ethiprole is not 
expected.
    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). A short-term 
adverse effect was identified; however, ethiprole is not registered for 
any use patterns that would result in short-term residential exposure. 
Short-term risk is assessed based on short-term residential exposure 
plus chronic dietary exposure. Because there is no short-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess short-term risk), no further 
assessment of short-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short-term risk for 
ethiprole.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
ethiprole is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic

[[Page 30938]]

dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
ethiprole.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA concluded that the nonlinear approach for assessing 
potential cancer risk from exposure to ethiprole is appropriate. As 
noted in this Unit, the chronic risk aggregate exposure to ethiprole is 
below the Agency's level of concern; therefore, the Agency concludes 
that there is not a cancer risk of concern from exposure to ethiprole.
    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 U.S. population, or to infants and children from 
aggregate exposure to ethiprole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The HPLC/MS-MS enforcement method, Method 01128, is acceptable for 
determination of residues of ethiprole and its sulfone metabolite RPA 
097973 for data collection in plant commodities. The GC-ECD method 
(Report No. B003572) is suitable for determining residues of parent 
ethiprole and RPA in milk, eggs and tissues. The FDA multiresidue 
method testing study for ethiprole is adequate and indicates that PAM 
multiresidue methods are not suitable for enforcing tolerances for 
residues of ethiprole.
    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. Codex has not 
established maximum residue limits (MRLs) for residues of ethiprole in 
coffee commodities; therefore, there are no harmonization issues at 
this time.

V. Conclusion

    Therefore, a tolerance is established for residues of the 
insecticide ethiprole, 5-amino-1-[2,6-dichloro-4-
(trifluoromethyl)phenyl]-4-(ethylsulfinyl)-1H-pyrazole-3-carbonitrile, 
including its metabolites and degradates, in or on coffee, green bean 
at 0.1 ppm. EPA is also amending the footnote in the table in paragraph 
(a) to accommodate the coffee commodity.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339), February 
3, 2017). This action does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA) (44 
U.S.C. 3501 et seq.), nor does it require any special considerations 
under Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 19, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

[[Page 30939]]

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.  180.652, revise paragraph (a) to read as follows:


Sec.  180.652   Ethiprole; tolerances for residues.

    (a) General. Tolerances are established for residues of ethiprole, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only ethiprole, 5-amino-1-[2,6-
dichloro-4-(trifluoromethyl)phenyl]-4-(ethylsulfinyl)-1H-pyrazole-3-
carbonitrile.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Coffee, green bean \1\......................................         0.1
Rice, grain \1\.............................................         1.7
Tea, dried \1\..............................................          30
------------------------------------------------------------------------
\1\ There are no U.S. registrations for this commodity as of June 28,
  2019.

* * * * *
[FR Doc. 2019-13546 Filed 6-27-19; 8:45 am]
 BILLING CODE 6560-50-P