[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Rules and Regulations]
[Pages 45844-45849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19760]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0505; FRL-9982-21]


Spiromesifen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
spiromesifen in or on coffee. Bayer CropScience requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 11, 2018. Objections and 
requests for hearings must be received on or before November 13, 2018, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0505, 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: [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-2017-0505 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 
November 13, 2018. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2017-0505, 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 February 27, 2018 (83 FR 8408) (FRL-
9972-17), 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 
7E8584) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle 
Park, NC 27709. The petition requested that 40 CFR part 180 be amended 
by establishing tolerances for residues of spiromesifen; 2-oxo-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate, and its enol metabolite (4-hydroxy-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one calculated as the 
stoichiometric equivalent of spiromesifen in or on the raw agricultural 
commodities: Coffee bean, green at 0.20 parts per million (ppm); 
coffee, instant at 0.20 ppm; and coffee bean, roasted at 0.20 ppm. That 
document referenced a summary of the petition prepared by Bayer 
CropScience, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the commodities for which tolerances are being established. 
The reason for these changes is explained in Unit IV.D.

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

[[Page 45845]]

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 spiromesifen including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with spiromesifen 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.
    Following oral administration of spiromesifen, the target organs 
included the thyroid gland for rats and dogs (increased thyroid-
stimulating hormone (TSH), increased thyroxine binding capacity, 
decreased triiodothyronine (T3) and thyroxine 
(T4) levels, colloidal alteration, and thyroid follicular 
cell hypertrophy), the liver for rats and dogs (increased alkaline 
phosphatase, alanine transaminase (ALT), and decreased cholesterol and 
triglycerides), the spleen for rats (atrophy, decreased spleen cell 
count, and increased macrophages), and the adrenal gland for mice 
(discoloration, decrease in fine vesiculation, and the presence of 
cytoplasmic eosinophilia in zona fasciculata cells). For rats, 
additional effects included reduced body weights and clinical signs 
(piloerection, reduced motility, spastic gait, and increased reactivity 
when touched).
    There were no adverse effects in rats following dermal exposure up 
to the limit dose (1,000 milligrams/kilograms/day (mg/kg/day)). 
Decreased spleen weights were also observed for rats in a 5-day 
inhalation toxicity study, along with gross pathological findings in 
the lung (dark red areas or foci) and clinical signs (e.g., tremors, 
clonic-tonic convulsions, reduced activity, bradypnea, etc.).
    While the clinical signs observed in rats following oral and 
inhalation exposures could indicate neurotoxicity, there was no 
evidence of neurotoxicity in the rest of the toxicological database, 
including the acute neurotoxicity study up to the limit dose (2,000 
milligrams/kilograms (mg/kg)) and the subchronic neurotoxicity study; 
however, the doses tested in the subchronic neurotoxicity study were 
lower than the doses causing clinical signs in the 90-day dietary study 
in rats. There was no evidence of immunotoxicity in an antibody plaque-
cell forming assay.
    There was no evidence of increased pre- or post-natal 
susceptibility. In the developmental toxicity studies in rats and 
rabbits, maternal effects were observed in the absence of fetal 
effects. In the rat two-generation reproductive toxicity study, the 
reported parental effects, consisting of decreased spleen weights 
(relative and absolute) and a decreasing number of ovarian follicles, 
occurred at a dose level that also caused pup body weight decrements 
during lactation.
    Spiromesifen is classified as ``Not likely to be Carcinogenic to 
Humans'' based on the absence of treatment-related tumors in two 
adequate rodent carcinogenicity studies. There was no concern for 
mutagenicity or genotoxicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by spiromesifen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled, ``Spiromesifen. Human 
Health Risk Assessment in Support of Proposed Tolerance for Residues of 
in/on Imported Coffee'' in docket ID number EPA-HQ-OPP-2017-0505.

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 the NOAEL and the LOAEL are identified. 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for spiromesifen used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Spiromesifen for Use in Human Health Risk Assessment
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                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
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Acute dietary (All populations)....  No appropriate toxicological effect attributable to a single dose was
                                      observed. Therefore, a dose and endpoint were not identified for this risk
                                      assessment.
----------------------------------------------------------------------------------------------------------------

[[Page 45846]]

 
Chronic dietary (All populations)..  NOAEL = 2.2 mg/kg/day.  Chronic RfD = 0.022 mg/ Two-Generation Reproduction
                                     UFA = 10x.............   kg/day.                 Study--Rats
                                     UFH = 10x.............  cPAD = 0.022 mg/kg/day  Parental LOAEL = 8.8 mg/kg
                                     FQPA SF = 1x..........                           bw/day based on
                                                                                      significantly decreased
                                                                                      spleen weight (absolute
                                                                                      and relative in parental
                                                                                      females and F1 males) and
                                                                                      significantly decreased
                                                                                      growing ovarian follicles
                                                                                      in females.
----------------------------------------------------------------------------------------------------------------
Oral short-term (1 to 30 days) and   NOAEL = 2.2 mg/kg/day.  LOC for MOE = 100.....  Two-Generation Reproduction
 intermediate-term (1-6 months).     UFA = 10x.............                           Study--Rats
                                     UFH = 10x.............                          Parental LOAEL = 8.8 mg/kg
                                     FQPA SF = 1x..........                           bw/day based on
                                                                                      significantly decreased
                                                                                      spleen weight (absolute
                                                                                      and relative in parental
                                                                                      females and F1 males) and
                                                                                      significantly decreased
                                                                                      growing ovarian follicles
                                                                                      in females.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30       Inhalation study NOAEC  LOC for MOE = 30        5-Day Inhalation Toxicity
 days) and intermediate-term (1-6     = 0.0794 mg/L/day.                              Study--Rats LOAEC = 0.5143
 months).                            UFA = 3x..............                           mg/L/day based on clinical
                                     UFH = 10x.............                           signs (tremors, clonic-
                                     FQPA SF = 1x..........                           tonic convulsions, reduced
                                                                                      activity, bradypnea,
                                                                                      labored breathing,
                                                                                      vocalization, avoidance
                                                                                      reaction, giddiness,
                                                                                      piloerection, limp,
                                                                                      emaciation, cyanosis,
                                                                                      squatted posture, apathy
                                                                                      and salivation), gross
                                                                                      pathology (dark red areas
                                                                                      or foci in the lungs and
                                                                                      bloated stomachs and pale
                                                                                      livers), and decreased
                                                                                      spleen weights.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..  Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                      absence of treatment-related tumors in two adequate rodent carcinogenicity
                                      studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). NOAEC = non-observed adverse-effect concentration. LOAEC =
  lowest-observed adverse-effect concentration.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spiromesifen, EPA considered exposure under the petitioned-
for tolerances as well as all existing spiromesifen tolerances in 40 
CFR 180.607. EPA assessed dietary exposures from spiromesifen in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for spiromesifen; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA; 2003-2008). 
As to residue levels in food, the chronic (food and water) analysis 
assumed 100 percent crop treated (PCT) and tolerance-level residues or 
tolerance-level residues adjusted to account for the residue of 
concern.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that spiromesifen 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 PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
spiromesifen. Tolerance level residues or tolerance-level residues 
adjusted to account for the residue of concern 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 spiromesifen in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of spiromesifen. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Provisional Cranberry model and Pesticide Water 
Calculator--Groundwater (PWC-GW) model, the estimated drinking water 
concentrations (EDWCs) of spiromesifen for chronic exposures are 
estimated to be 188 parts per billion (ppb) for surface water and 116 
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the chronic dietary risk 
assessment, the water concentration of value 188 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).
    Spiromesifen is currently registered for the following uses that 
could result in residential exposures: Ornamentals. EPA assessed 
residential exposure using the following assumptions: Short-term 
inhalation exposure to residential handlers is expected. A dermal 
assessment (handler and post-

[[Page 45847]]

application) was not conducted since no hazard was identified via the 
dermal route. Post-application inhalation exposures were not assessed 
due to the low vapor pressure and the expected dilution in outdoor 
sites. Post-application incidental oral exposure is considered unlikely 
since the use is restricted to ornamental plants (turf treatment is not 
permitted). Therefore, only short-term inhalation exposure to handlers 
was assessed. Further information regarding EPA standard assumptions 
and generic inputs for residential exposures may be found at http://www2.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 spiromesifen to share a common mechanism of 
toxicity with any other substances, and spiromesifen does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
spiromesifen 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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased pre- or post-natal susceptibility. In the developmental 
toxicity studies in rats and rabbits, maternal effects were observed in 
the absence of fetal effects. In the rat two-generation reproductive 
toxicity study, the reported parental effects, consisting of decreased 
spleen weights (relative and absolute) and a decreasing number of 
ovarian follicles, occurred at a dose level that also caused pup body 
weight decrements during lactation.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for spiromesifen is complete.
    ii. There is no indication that spiromesifen is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that spiromesifen results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to spiromesifen 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 
spiromesifen.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
spiromesifen is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
spiromesifen from food and water will utilize 68% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
spiromesifen 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). Spiromesifen 
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 spiromesifen.
    Because the level of concern (LOC) for inhalation (LOC for MOEs 
<30) and oral (LOC for MOEs <100) exposure differ, the aggregate 
assessment was calculated using the aggregate risk index (ARI) 
approach. The ARI was devised as a way to aggregate MOEs that have 
dissimilar uncertainty factors. The ARI is an extension of the MOE 
concept and as with the MOE, risk increases as the ARI decreases. An 
ARI that is greater than or equal to 1 is not of concern.
    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 an aggregate ARI of 1.87. Because 
EPA's level of concern for spiromesifen is an ARI of 1 or below, this 
ARI is not of concern.
    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, 
spiromesifen 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 
dietary exposure. Because there is no

[[Page 45848]]

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 spiromesifen.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, spiromesifen 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 spiromesifen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass 
spectrometry/mass spectrometry (LC/MS/MS)) 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: 
res[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 a MRL for residues of only spiromesifen in/on coffee 
beans of 0.05 ppm. Since the residue expression for the U.S. and Codex 
tolerances differ and since the maximum combined residues of 
spiromesifen and BSN 2060-enol in/on coffee green bean from the field 
trials was greater than 0.1 ppm, harmonization with the Codex 
expression/value is not possible. Note that BSN 2060-enol is included 
in the tolerance expression due to the demonstrated degradation of 
parent to BSN 2060-enol during storage.

C. Response to Comments

    Three comments were submitted to the docket for this action. Two 
comments, one about ``China's ongoing economic war against the United 
States'' and another about air and water pollution in China relative to 
that of the United States, are not relevant to this action. The third 
comment stated in part that ``the people drinking coffee should not 
have this toxic chemical as part of its drink.''
    The Agency recognizes that some individuals believe that pesticides 
should be banned on agricultural crops; however, the existing legal 
framework provided by section 408 of the FFDCA states that tolerances 
may be set when persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute. This citizen's comment appears to be directed at the 
underlying statute and not EPA's implementation of it; the citizen has 
made no contention that EPA has acted in violation of the statutory 
framework nor have they provided any specific information or allegation 
that would support a finding that these tolerances are unsafe.

D. Revisions to Petitioned-For Tolerances

    The green coffee bean tolerance being established is identical to 
that proposed by the petitioner. EPA has determined that separate 
tolerances for the processed commodities of roasted coffee bean and 
instant coffee are unnecessary because the processing data indicates 
that combined residues of spiromesifen and BSN 2060-enol do not 
concentrate in roasted or instant coffee.

V. Conclusion

    Therefore, a tolerance is established for residues of spiromesifen, 
including its metabolites and degradates, in or on coffee, green bean 
at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) 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.).

[[Page 45849]]

    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: August 28, 2018.
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.  180.607, add alphabetically the commodity ``coffee, green 
bean'' and footnote 1 to the table in paragraph (a)(1) to read as 
follows:

Sec.  180.607  Spiromesifen; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Coffee, green bean \1\.....................................         0.20
 
                                * * * * *
------------------------------------------------------------------------
\1\ This use has not been registered in the United States as of August
  28, 2018.

* * * * *

[FR Doc. 2018-19760 Filed 9-10-18; 8:45 am]
 BILLING CODE 6560-50-P


