80_FR_54416 80 FR 54242 - Cyprodinil; Pesticide Tolerances

80 FR 54242 - Cyprodinil; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 174 (September 9, 2015)

Page Range54242-54248
FR Document2015-22031

This regulation establishes tolerances for residues of cyprodinil in or on multiple commodities that are identified and discussed later in this document, and removes the established tolerance on fruit, stone, group 12. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 80 Issue 174 (Wednesday, September 9, 2015)
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Rules and Regulations]
[Pages 54242-54248]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-22031]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0506; FRL-9930-04]


Cyprodinil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyprodinil in or on multiple commodities that are identified and 
discussed later in this document, and removes the established tolerance 
on fruit, stone, group 12. Interregional Research Project Number 4

[[Page 54243]]

(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective September 9, 2015. Objections and 
requests for hearings must be received on or before November 9, 2015, 
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-2014-0506, 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 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-2014-0506 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 9, 2015. 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-2014-0506, 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 September 5, 2014 (79 FR 53009) (FRL-
9914-98), 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 
4E8293) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 
08540. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide cyprodinil, 4-
cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on acerola at 1.5 
parts per million (ppm); artichoke, globe at 4.0 ppm; feijoa at 1.5 
ppm; fruit, stone group 12-12 at 2.0 ppm; guava at 1.5 ppm; jaboticaba 
at 1.5 ppm; passionfruit at 1.5 ppm; pomegranate at 7.0 ppm; starfruit 
at 1.5 ppm; and wax jambu at 1.5 ppm. This petition additionally 
requested to remove the tolerance in 40 CFR 180.532 for residues of 
cyprodinil in or on fruit, stone, group 12 at 2.0 ppm. That document 
referenced a summary of the petition prepared on behalf of IR-4 by 
Syngenta Crop Protection, 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 
revised the proposed tolerance on pomegranate, and has revised the 
commodity definition for artichoke to artichoke, globe. The reasons for 
these changes are 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 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

[[Page 54244]]

aggregate exposure for cyprodinil including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with cyprodinil follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The major target organs of cyprodinil are the liver and the kidney. 
Liver effects were consistent among rats and mice in both subchronic 
and chronic studies and typically included increased liver weights and 
increases in serum clinical chemistry parameters, associated with 
adverse effects on liver function (i.e., increased cholesterol and 
phospholipid levels). Microscopic lesions in rats and mice included 
hepatocyte hypertrophy and hepatocellular necrosis. In the kidneys, 
chronic tubular lesions and chronic kidney inflammation following 
subchronic exposure and increased kidney weights and progressive 
nephropathy following chronic exposures in male rats. Chronic effects 
in dogs were limited to decreased body-weight gain, decreased food 
consumption and decreased food efficiency. The hematopoietic system 
also appeared to be a target of cyprodinil, as mild anemia was seen 
following subchronic rat exposure (reductions in hematocrit and 
hemoglobin and microcytosis). Although increases in thyroid weight or 
hypertrophy of thyroid follicular cells were observed at higher doses 
in the 28-day and 90-day oral toxicity study in rats, treatment-related 
changes in thyroid weights or gross/microscopic observations were not 
observed in the chronic rat study or in other studies.
    A 28-day dietary immunotoxicity study in mice resulted in no 
apparent suppression of the humoral component of the immune system. The 
only effect attributed to cyprodinil treatment was higher liver weights 
at the highest dose tested. There were no treatment-related effects on 
spleen or thymus weights; no effects on specific activity or total 
activity of splenic immunoglobulin M (IgM) antibody-forming cells to 
the T cell-dependent antigen sheep red blood cells (sRBC).
    An acute neurotoxicity study indicated systemic toxicity with signs 
of induced hunched posture, pilorection, and reduced responsiveness to 
sensory stimuli and reduced motor activity. Clinical signs, 
hypothermia, and changes in motor activity were found to be reversible 
by day 8 and 15 investigations. A subchronic neurotoxicity study showed 
no treatment related effects on mortality, clinical signs, or gross or 
histological neuropathology. Functional observational battery (FOB) and 
motor activity testing revealed no treatment related effects up to the 
highest dose tested.
    There was no evidence of increased susceptibility in the 
developmental rat or rabbit study following in utero exposure or in the 
two-generation reproduction study following pre- and post-natal 
exposure. Fetal toxicity, manifested as significantly lower fetal 
weights and an increased incidence of delayed ossification in the rat 
and a slight increase in litters showing extra ribs in the rabbit, was 
reported in developmental toxicity studies. In a rat two-generation 
reproduction study, significantly lower pup weights for F1 
and F2 offspring were observed. Each of these fetal or 
neonatal effects occurred at the same dose levels at which maternal 
toxicity (decreased body weight gain) was observed and were considered 
to be secondary to maternal toxicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by cyprodinil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: Cyprodinil. Human Health Risk 
Assessment for the Expansion of Existing Crop Group/Representative 
Commodity Uses to Stone Fruit Group 12-12, and Adding New Uses on the 
Artichoke, Guava, Pomegranate, Passionfruit, Feijoa, Jaboticaba, Wax 
Jambu, Starfruit, and Acerola and Amended Uses on Greenhouse Cucumbers 
and Small Tomatoes at pages 36-40 in docket ID number EPA-HQ-OPP-2014-
0506.

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 cyprodinil used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of October 16, 2012 (77 FR 49732) 
(FRL-9359-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyprodinil, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyprodinil tolerances in 40 CFR 
180.532. EPA assessed dietary exposures from cyprodinil 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. Such effects were identified 
for cyprodinil. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) National Health and Nutrition Examination Survey, 
What We Eat in America, (NHANES/WWEIA), from 2003 to 2008. As to 
residue levels in food, EPA utilized tolerance-level residues and 100 
percent crop treated (PCT) for all commodities. The acute assessment 
also incorporated Dietary Exposure Evaluation Model software with the 
Food Commodity Intake Database (DEEM-FCID) Version 3.18 default 
processing factors; and empirical processing factors for tomato paste/
tomato puree and lemon/lime juice, where 1X empirical processing 
factors were used to modify the tolerance values.

[[Page 54245]]

    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA. As to residue levels in food, EPA utilized average field trial 
residues for pome fruit, head lettuce, leaf lettuce, spinach, tomato, 
and grape and tolerance-level residues for the remaining commodities. 
The Agency also assumed 100 PCT. The chronic assessment also 
incorporated DEEM default processing factors except for tomato paste/
tomato puree and lemon juice/lime juice, where a 1X empirical 
processing factor was used to modify the tolerance values.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that cyprodinil 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. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    2. Dietary exposure from drinking water. The residues of concern in 
drinking water for risk assessment purposes are cyprodinil and the 
degradate CGA 249287. The estimated drinking water concentrations 
(EDWCs) for each of these was calculated using a molecular weight 
conversion and then combined for each modeled scenario. The Agency used 
screening level water exposure models in the dietary exposure analysis 
and risk assessment for cyprodinil and CGA 249287 in drinking water. 
These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of cyprodinil and CGA 
249287. Further information regarding EPA drinking water models used in 
pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS), Screening Concentration in Ground Water (SCI-
GROW), and Pesticide Root Zone Model for Groundwater (PRZM-GW) models, 
the EDWCs of cyprodinil and CGA 249287 for acute exposures are 
estimated to be 34.8 parts per billion (ppb) for surface water and 2.05 
ppb for ground water. EDWCs for chronic exposures for non-cancer 
assessments are estimated to be 24.7 ppb for surface water and 1.80 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The water concentration values 
of 34.8 ppb and 24.7 ppb were used to assess the contribution to 
drinking water for the acute and chronic dietary risk assessments, 
respectively.
    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).
    Cyprodinil is currently registered for the following uses that 
could result in residential exposures: Ornamental landscapes. EPA 
assessed residential exposure using the following assumptions: Short-
term inhalation exposures to adult residential handlers from the 
application of cyprodinil to ornamental landscapes. The residential 
handler exposure scenarios were considered to be short-term only, due 
to the infrequent use patterns associated with homeowner products. 
Dermal exposures were not assessed since there was no dermal endpoint 
identified for cyprodinil. Postapplication exposures to adults or 
children were not expected and were not assessed. Further information 
regarding EPA standard assumptions and generic inputs for residential 
exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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 cyprodinil to share a common mechanism of 
toxicity with any other substances, and cyprodinil does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
cyprodinil 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 Web site 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 available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. In a rat developmental 
toxicity study, there were significantly lower mean fetal weights in 
the high dose group compared to controls as well as a significant 
increase in skeletal anomalies in the high dose group due to abnormal 
ossification. The skeletal anomalies or variations were considered to 
be a transient developmental delay that occurred secondary to the 
maternal toxicity noted in the high dose group. In the rabbit study, 
the only treatment-related developmental effect was the indication of 
an increased incidence of a 13th rib at maternally toxic doses. Signs 
of fetal effects in the reproductive toxicity study included 
significantly lower F1 and F2 pup weights in the high dose group during 
lactation, which continued to be lower than controls post-weaning and 
after the pre-mating period in the F1 generation. Reproductive effects 
were seen only at doses that also caused parental toxicity.
    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 for non-inhalation exposure scenarios. For 
inhalation exposure scenarios for all population groups, EPA is 
retaining a 10X FQPA SF. That decision is based on the following 
findings:
    i. The toxicity database for cyprodinil is complete, except for a 
90-day inhalation toxicity study. In the absence of a route-specific 
inhalation study, EPA is relying on the 28-day feeding/range-

[[Page 54246]]

finding rat oral study to estimate risk from inhalation exposures. EPA 
has determined that the use of this study to extrapolate an inhalation 
endpoint may understate risk. Accordingly, to address this uncertainty, 
EPA has concluded that the 10X FQPA SF should be retained for risk 
assessments involving inhalation exposure.
    ii. As to evidence of neurotoxicity, in an acute neurotoxicity 
study in rats clinical signs, hypothermia, and changes in motor 
activity were all found to be reversible and no longer seen at day 8 
and 15 investigations. There were no treatment-related effects on 
mortality or gross or histological neuropathology. Reduced motor 
activity, induced hunched posture, piloerection and reduced 
responsiveness to sensory stimuli were observed and disappeared in all 
animals by day three to four. For the subchronic neurotoxicity study in 
rats, there was no indication that cyprodinil is a neurotoxic chemical. 
Based on this evidence, there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. When toxicity was observed in the prenatal developmental 
toxicity studies in rats and rabbits and the two-generation 
reproduction study in rats, toxicity to the fetuses or offspring 
occurred at the same doses at which effects were observed in maternal/
parental animals. Additionally, the skeletal anomalies or variations 
were considered to be a transient developmental delay that occurred 
secondary to the maternal toxicity noted in the high dose group. 
Therefore, there is no evidence that cyprodinil results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the two-generation 
reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary assessment was conservative and based upon 
100 PCT and tolerance-level residues, as well as DEEM default and 
empirical processing factors. The chronic dietary assessment was 
partially refined with average field trial residues for some 
commodities and tolerance-level residues for the remaining commodities. 
DEEM default and empirical processing factors were also incorporated 
into the chronic dietary assessment. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to cyprodinil in drinking water. Based on the discussion in 
Unit III.C.3, postapplication exposure of children as well as 
incidental oral exposure of toddlers is not expected. These assessments 
will not underestimate the exposure and risks posed by cyprodinil.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to cyprodinil will occupy 8.6% of the aPAD for children one to two 
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 
cyprodinil from food and water will utilize 85% of the cPAD for 
children one to two 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 
cyprodinil 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). Cyprodinil 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 cyprodinil.
    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 MOE of 7,900. Because 
EPA's level of concern for cyprodinil is a MOE of 1,000 or below, these 
MOEs are 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, 
cyprodinil 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 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 
cyprodinil.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, cyprodinil 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 cyprodinil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate high performance liquid chromatography, using ultra-violet 
detection (HPLC/UV) methods (Methods AG-631 and AG-631B) are available 
to enforce the tolerance expression of cyprodinil in/on plant 
commodities.
    The methods 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,

[[Page 54247]]

FFDCA section 408(b)(4) requires that EPA explain the reasons for 
departing from the Codex level.
    The Codex has established MRLs for cyprodinil in or on stone fruit 
at 2.0 ppm. This MRL is the same as the tolerance established for 
cyprodinil in the United States for fruit, stone, group 12-12. The 
Codex has not established a MRL for cyprodinil in or on the other 
commodities associated with this action.

C. Response to Comments

    Several comments were received in response to the notice of filing. 
All but one were concerned with potential environmental impacts, and 
were not specifically related to the cyprodinil action. EPA notes that 
these comments address potential environmental concerns; however, the 
safety standard for approving tolerances under section 408 of the FFDCA 
focuses on potential harms to human health and does not permit 
consideration of effects on the environment.
    One additional comment was received that did not specifically 
address the cyprodinil action, but that raised concerns about the 
toxicity of pesticides and requested that no tolerance be established. 
The Agency understands the commenter's concerns and 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. EPA has found 
that there is a reasonable certainty of no harm to humans after 
considering the toxicological studies and the exposure levels of humans 
to cyprodinil.

D. Revisions to Petitioned-For Tolerances

    Based on the data submitted with the petition, EPA has determined 
that the proposed tolerance in or on pomegranate at 7.0 ppm should be 
established at 10 ppm. This tolerance level was determined by the 
Organization for Economic Cooperation and Development tolerance 
calculation procedures. Additionally, the Agency is establishing a 
tolerance in or on artichoke, globe, rather than the petitioned-for 
commodity artichoke in order to provide the correct commodity 
definition.

 V. Conclusion

    Therefore, tolerances are established for residues of cyprodinil, 
4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on acerola at 
1.5 ppm; artichoke, globe at 4.0 ppm; feijoa at 1.5 ppm; fruit, stone, 
group 12-12 at 2.0 ppm; guava at 1.5 ppm; jaboticaba at 1.5 ppm; 
passionfruit at 1.5 ppm; pomegranate at 10 ppm; starfruit at 1.5 ppm; 
and wax jambu at 1.5 ppm. Additionally, this action removes the 
tolerance established in or on fruit, stone, group 12 at 2.0 ppm as 
that crop group tolerance is superseded by the tolerance being 
established in this action for crop group 12-12.

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). 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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

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 13, 2015.
Susan Lewis,
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.  180.532, remove the entry, ``Fruit, stone, group 12'' and 
alphabetically add the following commodities to the table in paragraph 
(a) to read as follows:

[[Page 54248]]

Sec.  180.532  Cyprodinil; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................         1.5
 
                                * * * * *
Artichoke, globe............................................         4.0
 
                                * * * * *
Feijoa......................................................         1.5
 
                                * * * * *
Fruit, stone, group 12-12...................................         2.0
 
                                * * * * *
Guava.......................................................         1.5
 
                                * * * * *
Jaboticaba..................................................         1.5
 
                                * * * * *
Passionfruit................................................         1.5
 
                                * * * * *
Pomegranate.................................................          10
 
                                * * * * *
Starfruit...................................................         1.5
 
                                * * * * *
Wax jambu...................................................         1.5
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-22031 Filed 9-8-15; 8:45 am]
 BILLING CODE 6560-50-P



                                           54242        Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations

                                           beyond those imposed by state law. For                  required information to the U.S. Senate,              January 10, 2013. In addition, revisions
                                           that reason, this action:                               the U.S. House of Representatives, and                to the Utah State Implementation Plan
                                              • Is not a significant regulatory action             the Comptroller General of the United                 involving; Section X, Vehicle Inspection
                                           subject to review by the Office of                      States prior to publication of the rule in            and Maintenance Program, Part F,
                                           Management and Budget under                             the Federal Register. A major rule                    Cache County and Utah Rule R307–110–
                                           Executive Orders 12866 (58 FR 51735,                    cannot take effect until 60 days after it             36 were submitted for Agency action.
                                           October 4, 1993) and 13563 (76 FR 3821,                 is published in the Federal Register.                 These SIP revisions were adopted by the
                                           January 21, 2011);                                      This action is not a ‘‘major rule’’ as                UAQB November 6, 2013, they became
                                              • does not impose an information                     defined by 5 U.S.C. 804(2).                           State effective on November 7, 2013,
                                           collection burden under the provisions                     Under section 307(b)(1) of the Clean               and were submitted by the Governor to
                                           of the Paperwork Reduction Act (44                      Air Act, petitions for judicial review of             EPA by a letter dated January 28, 2014.
                                           U.S.C. 3501 et se.);                                    this action must be filed in the United                 (i) Incorporation by reference.
                                              • is certified as not having a                       States Court of Appeals for the                         (A)(1) Utah Rules R307,
                                           significant economic impact on a                        appropriate circuit by November 9,                    Environmental Quality, Air Quality,
                                           substantial number of small entities                    2015. Filing a petition for                           R307–110, General Requirements: State
                                           under the Regulatory Flexibility Act (5                 reconsideration by the Administrator of               Implementation Plan, R307–110–1,
                                           U.S.C. 601 et se.);                                     this final rule does not affect the finality          Incorporation by Reference, and R307–
                                              • does not contain any unfunded                      of this action for the purposes of judicial           110–31, Section X, Vehicle Inspection
                                           mandate or significantly or uniquely                    review nor does it extend the time                    and Maintenance Program, Part A,
                                           affect small governments, as described                  within which a petition for judicial                  General Requirements and
                                           in the Unfunded Mandates Reform Act                     review may be filed, and shall not                    Applicability; effective December 6,
                                           of 1995 (Public Law 104–4);                             postpone the effectiveness of such rule               2012, as proposed in the Utah State
                                              • does not have Federalism                           or action. This action may not be                     Bulletin on October 1, 2012, and
                                           implications as specified in Executive                  challenged later in proceedings to                    published as adopted in the Utah State
                                           Order 13132 (64 FR 43255, August 10,                    enforce its requirements. (See CAA                    Bulletin on January 1, 2013.
                                           1999);                                                  section 307(b)(2).)                                     (2) Section X, Vehicle Inspection and
                                              • is not an economically significant                                                                       Maintenance Program, Part A, General
                                           regulatory action based on health or                    List of Subjects in 40 CFR Part 52                    Requirements and Applicability,
                                           safety risks subject to Executive Order                   Environmental protection, Air                       adopted by the Utah Air Quality Board
                                           13045 (62 FR 19885, April 23, 1997);                    pollution control, Carbon monoxide,                   on December 5, 2012. (B)(1) Utah Rule
                                              • is not a significant regulatory action             Incorporation by reference,                           R307, Environmental Quality, Air
                                           subject to Executive Order 13211 (66 FR                 Intergovernmental relations, Nitrogen                 Quality, R307–110, General
                                           28355, May 22, 2001);                                   dioxide, Ozone, Particulate matter,                   Requirements: State Implementation
                                              • is not subject to requirements of                  Reporting and recordkeeping                           Plan, R307–110–36, Section X, Vehicle
                                           Section 12(d) of the National                           requirements, and Volatile organic                    Inspection and Maintenance Program,
                                           Technology Transfer and Advancement                     compounds.                                            Part F, Cache County; effective
                                           Act of 1995 (15 U.S.C. 272 note) because                                                                      November 7, 2013, as proposed in the
                                           application of those requirements would                     Authority: 42 U.S.C. 7401 et seq.
                                                                                                                                                         Utah State Bulletin on September 1,
                                           be inconsistent with the Clean Air Act;                   Dated: July 1, 2015.                                2013, and published as adopted in the
                                           and                                                     Shaun L. McGrath,                                     Utah State Bulletin on December 1,
                                              • does not provide EPA with the                      Regional Administrator, Region 8.                     2013.
                                           discretionary authority to address, as                                                                          (2) Section X, Vehicle Inspection and
                                           appropriate, disproportionate human                         40 CFR part 52 is amended as follows:
                                                                                                                                                         Maintenance Program Part F, Cache
                                           health or environmental effects, using                                                                        County, adopted by the Utah Air Quality
                                                                                                   PART 52 [AMENDED]
                                           practicable and legally permissible                                                                           Board on November 6, 2013.
                                           methods, under Executive Order 12898                    ■ 1. The authority citation for Part 52               *      *    *     *    *
                                           (59 FR 7629, February 16, 1994).                        continues to read as follows:
                                              The SIP is not approved to apply on                                                                        [FR Doc. 2015–22594 Filed 9–8–15; 8:45 am]
                                           any Indian reservation land or in any                       Authority: 42 U.S.C. 7401 et seq.                 BILLING CODE 6560–50–P
                                           other area where EPA or an Indian tribe                 Subpart TT—Utah
                                           has demonstrated that a tribe has
                                           jurisdiction. In those areas of Indian                                                                        ENVIRONMENTAL PROTECTION
                                                                                                   ■ 2. Section 52.2320 is amended by
                                           country, the rule does not have tribal                                                                        AGENCY
                                                                                                   adding paragraph (c)(80) to read as
                                           implications and will not impose                        follows:                                              40 CFR Part 180
                                           substantial direct costs on tribal
                                           governments or preempt tribal law as                    § 52.2320    Identification of plan.                  [EPA–HQ–OPP–2014–0506; FRL–9930–04]
                                           specified by Executive Order 13175 (65                  *     *     *    *     *
                                           FR 67249, November 9, 2000).                              (c) * * *                                           Cyprodinil; Pesticide Tolerances
                                              The Congressional Review Act, 5                        (80) Revisions to the Utah State                    AGENCY:  Environmental Protection
                                           U.S.C. 801 et seq., as added by the Small               Implementation Plan involving Section                 Agency (EPA).
                                           Business Regulatory Enforcement                         X, Vehicle Inspection and Maintenance                 ACTION: Final rule.
                                           Fairness Act of 1996, generally provides                Program, Part A, General Requirements
                                           that before a rule may take effect, the                 and Applicability, and Utah Rules                     SUMMARY:   This regulation establishes
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                                           agency promulgating the rule must                       R307–110–1 and R307–110–31. The                       tolerances for residues of cyprodinil in
                                           submit a rule report, which includes a                  Utah Air Quality Board (UAQB) adopted                 or on multiple commodities that are
                                           copy of the rule, to each House of the                  these SIP revisions on December 5,                    identified and discussed later in this
                                           Congress and to the Comptroller General                 2012, they became state effective on                  document, and removes the established
                                           of the United States. EPA will submit a                 December 6, 2012, and were submitted                  tolerance on fruit, stone, group 12.
                                           report containing this action and other                 by the Governor to EPA by a letter dated              Interregional Research Project Number 4


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                                                        Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations                                          54243

                                           (IR–4) requested these tolerances under                 site at http://www.ecfr.gov/cgi-bin/text-             500 College Road East, Suite 201W,
                                           the Federal Food, Drug, and Cosmetic                    idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  Princeton, NJ 08540. The petition
                                           Act (FFDCA).                                            40tab_02.tpl.                                         requested that 40 CFR part 180 be
                                           DATES: This regulation is effective                                                                           amended by establishing tolerances for
                                                                                                   C. How can I file an objection or hearing
                                           September 9, 2015. Objections and                                                                             residues of the fungicide cyprodinil, 4-
                                                                                                   request?
                                           requests for hearings must be received                                                                        cyclopropyl-6-methyl-N-phenyl-2-
                                           on or before November 9, 2015, and                        Under FFDCA section 408(g), 21                      pyrimidinamine, in or on acerola at 1.5
                                           must be filed in accordance with the                    U.S.C. 346a, any person may file an                   parts per million (ppm); artichoke, globe
                                           instructions provided in 40 CFR part                    objection to any aspect of this regulation            at 4.0 ppm; feijoa at 1.5 ppm; fruit, stone
                                           178 (see also Unit I.C. of the                          and may also request a hearing on those               group 12–12 at 2.0 ppm; guava at 1.5
                                           SUPPLEMENTARY INFORMATION).                             objections. You must file your objection              ppm; jaboticaba at 1.5 ppm; passionfruit
                                                                                                   or request a hearing on this regulation               at 1.5 ppm; pomegranate at 7.0 ppm;
                                           ADDRESSES: The docket for this action,
                                                                                                   in accordance with the instructions                   starfruit at 1.5 ppm; and wax jambu at
                                           identified by docket identification (ID)
                                                                                                   provided in 40 CFR part 178. To ensure                1.5 ppm. This petition additionally
                                           number EPA–HQ–OPP–2014–0506, is
                                                                                                   proper receipt by EPA, you must                       requested to remove the tolerance in 40
                                           available at http://www.regulations.gov
                                                                                                   identify docket ID number EPA–HQ–                     CFR 180.532 for residues of cyprodinil
                                           or at the Office of Pesticide Programs
                                                                                                   OPP–2014–0506 in the subject line on                  in or on fruit, stone, group 12 at 2.0
                                           Regulatory Public Docket (OPP Docket)
                                                                                                   the first page of your submission. All                ppm. That document referenced a
                                           in the Environmental Protection Agency
                                                                                                   objections and requests for a hearing                 summary of the petition prepared on
                                           Docket Center (EPA/DC), West William
                                                                                                   must be in writing, and must be                       behalf of IR–4 by Syngenta Crop
                                           Jefferson Clinton Bldg., Rm. 3334, 1301
                                                                                                   received by the Hearing Clerk on or                   Protection, the registrant, which is
                                           Constitution Ave. NW., Washington, DC
                                                                                                   before November 9, 2015. Addresses for                available in the docket, http://
                                           20460–0001. The Public Reading Room
                                                                                                   mail and hand delivery of objections                  www.regulations.gov. Comments were
                                           is open from 8:30 a.m. to 4:30 p.m.,
                                                                                                   and hearing requests are provided in 40               received on the notice of filing. EPA’s
                                           Monday through Friday, excluding legal
                                                                                                   CFR 178.25(b).                                        response to these comments is
                                           holidays. The telephone number for the                    In addition to filing an objection or               discussed in Unit IV.C.
                                           Public Reading Room is (202) 566–1744,                  hearing request with the Hearing Clerk                   Based upon review of the data
                                           and the telephone number for the OPP                    as described in 40 CFR part 178, please               supporting the petition, EPA has revised
                                           Docket is (703) 305–5805. Please review                 submit a copy of the filing (excluding                the proposed tolerance on pomegranate,
                                           the visitor instructions and additional                 any Confidential Business Information                 and has revised the commodity
                                           information about the docket available                  (CBI)) for inclusion in the public docket.            definition for artichoke to artichoke,
                                           at http://www.epa.gov/dockets.                          Information not marked confidential                   globe. The reasons for these changes are
                                           FOR FURTHER INFORMATION CONTACT:                        pursuant to 40 CFR part 2 may be                      explained in Unit IV.D.
                                           Susan Lewis, Registration Division                      disclosed publicly by EPA without prior
                                           (7505P), Office of Pesticide Programs,                                                                        III. Aggregate Risk Assessment and
                                                                                                   notice. Submit the non-CBI copy of your               Determination of Safety
                                           Environmental Protection Agency, 1200                   objection or hearing request, identified
                                           Pennsylvania Ave. NW., Washington,                      by docket ID number EPA–HQ–OPP–                          Section 408(b)(2)(A)(i) of FFDCA
                                           DC 20460–0001; main telephone                           2014–0506, by one of the following                    allows EPA to establish a tolerance (the
                                           number: (703) 305–7090; email address:                  methods:                                              legal limit for a pesticide chemical
                                           RDFRNotices@epa.gov.                                      • Federal eRulemaking Portal: http://               residue in or on a food) only if EPA
                                           SUPPLEMENTARY INFORMATION:                              www.regulations.gov. Follow the online                determines that the tolerance is ‘‘safe.’’
                                                                                                   instructions for submitting comments.                 Section 408(b)(2)(A)(ii) of FFDCA
                                           I. General Information                                                                                        defines ‘‘safe’’ to mean that ‘‘there is a
                                                                                                   Do not submit electronically any
                                           A. Does this action apply to me?                        information you consider to be CBI or                 reasonable certainty that no harm will
                                              You may be potentially affected by                   other information whose disclosure is                 result from aggregate exposure to the
                                           this action if you are an agricultural                  restricted by statute.                                pesticide chemical residue, including
                                           producer, food manufacturer, or                           • Mail: OPP Docket, Environmental                   all anticipated dietary exposures and all
                                           pesticide manufacturer. The following                   Protection Agency Docket Center (EPA/                 other exposures for which there is
                                           list of North American Industrial                       DC), (28221T), 1200 Pennsylvania Ave.                 reliable information.’’ This includes
                                           Classification System (NAICS) codes is                  NW., Washington, DC 20460–0001.                       exposure through drinking water and in
                                           not intended to be exhaustive, but rather                 • Hand Delivery: To make special                    residential settings, but does not include
                                           provides a guide to help readers                        arrangements for hand delivery or                     occupational exposure. Section
                                           determine whether this document                         delivery of boxed information, please                 408(b)(2)(C) of FFDCA requires EPA to
                                           applies to them. Potentially affected                   follow the instructions at http://                    give special consideration to exposure
                                           entities may include:                                   www.epa.gov/dockets/contacts.html.                    of infants and children to the pesticide
                                              • Crop production (NAICS code 111).                  Additional instructions on commenting                 chemical residue in establishing a
                                              • Animal production (NAICS code                      or visiting the docket, along with more               tolerance and to ‘‘ensure that there is a
                                           112).                                                   information about dockets generally, is               reasonable certainty that no harm will
                                              • Food manufacturing (NAICS code                     available at http://www.epa.gov/                      result to infants and children from
                                           311).                                                   dockets.                                              aggregate exposure to the pesticide
                                              • Pesticide manufacturing (NAICS                                                                           chemical residue. . . .’’
                                                                                                   II. Summary of Petitioned-For                            Consistent with FFDCA section
                                           code 32532).
                                                                                                   Tolerance                                             408(b)(2)(D), and the factors specified in
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                                           B. How can I get electronic access to                      In the Federal Register of September               FFDCA section 408(b)(2)(D), EPA has
                                           other related information?                              5, 2014 (79 FR 53009) (FRL–9914–98),                  reviewed the available scientific data
                                             You may access a frequently updated                   EPA issued a document pursuant to                     and other relevant information in
                                           electronic version of EPA’s tolerance                   FFDCA section 408(d)(3), 21 U.S.C.                    support of this action. EPA has
                                           regulations at 40 CFR part 180 through                  346a(d)(3), announcing the filing of a                sufficient data to assess the hazards of
                                           the Government Printing Office’s e-CFR                  pesticide petition (PP 4E8293) by IR–4,               and to make a determination on


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                                           54244        Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations

                                           aggregate exposure for cyprodinil                       and reduced responsiveness to sensory                 analysis of the doses in each
                                           including exposure resulting from the                   stimuli and reduced motor activity.                   toxicological study to determine the
                                           tolerances established by this action.                  Clinical signs, hypothermia, and                      dose at which no adverse effects are
                                           EPA’s assessment of exposures and risks                 changes in motor activity were found to               observed (the NOAEL) and the lowest
                                           associated with cyprodinil follows.                     be reversible by day 8 and 15                         dose at which adverse effects of concern
                                                                                                   investigations. A subchronic                          are identified (the LOAEL). Uncertainty/
                                           A. Toxicological Profile
                                                                                                   neurotoxicity study showed no                         safety factors are used in conjunction
                                              EPA has evaluated the available                      treatment related effects on mortality,               with the POD to calculate a safe
                                           toxicity data and considered its validity,              clinical signs, or gross or histological              exposure level—generally referred to as
                                           completeness, and reliability as well as                neuropathology. Functional                            a population-adjusted dose (PAD) or a
                                           the relationship of the results of the                  observational battery (FOB) and motor                 reference dose (RfD)—and a safe margin
                                           studies to human risk. EPA has also                     activity testing revealed no treatment                of exposure (MOE). For non-threshold
                                           considered available information                        related effects up to the highest dose                risks, the Agency assumes that any
                                           concerning the variability of the                       tested.                                               amount of exposure will lead to some
                                           sensitivities of major identifiable                        There was no evidence of increased                 degree of risk. Thus, the Agency
                                           subgroups of consumers, including                       susceptibility in the developmental rat               estimates risk in terms of the probability
                                           infants and children.                                   or rabbit study following in utero                    of an occurrence of the adverse effect
                                              The major target organs of cyprodinil                exposure or in the two-generation                     expected in a lifetime. For more
                                           are the liver and the kidney. Liver                     reproduction study following pre- and                 information on the general principles
                                           effects were consistent among rats and                  post-natal exposure. Fetal toxicity,                  EPA uses in risk characterization and a
                                           mice in both subchronic and chronic                     manifested as significantly lower fetal               complete description of the risk
                                           studies and typically included increased                weights and an increased incidence of                 assessment process, see http://
                                           liver weights and increases in serum                    delayed ossification in the rat and a                 www.epa.gov/pesticides/factsheets/
                                           clinical chemistry parameters,                          slight increase in litters showing extra              riskassess.htm.
                                           associated with adverse effects on liver                ribs in the rabbit, was reported in                      A summary of the toxicological
                                           function (i.e., increased cholesterol and               developmental toxicity studies. In a rat              endpoints for cyprodinil used for
                                           phospholipid levels). Microscopic                       two-generation reproduction study,                    human risk assessment is discussed in
                                           lesions in rats and mice included                       significantly lower pup weights for F1                Unit III.B. of the final rule published in
                                           hepatocyte hypertrophy and                              and F2 offspring were observed. Each of               the Federal Register of October 16, 2012
                                           hepatocellular necrosis. In the kidneys,                these fetal or neonatal effects occurred              (77 FR 49732) (FRL–9359–7).
                                           chronic tubular lesions and chronic                     at the same dose levels at which
                                           kidney inflammation following                                                                                 C. Exposure Assessment
                                                                                                   maternal toxicity (decreased body
                                           subchronic exposure and increased                       weight gain) was observed and were                       1. Dietary exposure from food and
                                           kidney weights and progressive                          considered to be secondary to maternal                feed uses. In evaluating dietary
                                           nephropathy following chronic                           toxicity.                                             exposure to cyprodinil, EPA considered
                                           exposures in male rats. Chronic effects                    Specific information on the studies                exposure under the petitioned-for
                                           in dogs were limited to decreased body-                 received and the nature of the adverse                tolerances as well as all existing
                                           weight gain, decreased food                             effects caused by cyprodinil as well as               cyprodinil tolerances in 40 CFR
                                           consumption and decreased food                          the no-observed-adverse-effect-level                  180.532. EPA assessed dietary
                                           efficiency. The hematopoietic system                    (NOAEL) and the lowest-observed-                      exposures from cyprodinil in food as
                                           also appeared to be a target of                         adverse-effect-level (LOAEL) from the                 follows:
                                           cyprodinil, as mild anemia was seen                     toxicity studies can be found at http://                 i. Acute exposure. Quantitative acute
                                           following subchronic rat exposure                       www.regulations.gov in document:                      dietary exposure and risk assessments
                                           (reductions in hematocrit and                           Cyprodinil. Human Health Risk                         are performed for a food-use pesticide,
                                           hemoglobin and microcytosis).                           Assessment for the Expansion of                       if a toxicological study has indicated the
                                           Although increases in thyroid weight or                 Existing Crop Group/Representative                    possibility of an effect of concern
                                           hypertrophy of thyroid follicular cells                 Commodity Uses to Stone Fruit Group                   occurring as a result of a 1-day or single
                                           were observed at higher doses in the 28-                12–12, and Adding New Uses on the                     exposure. Such effects were identified
                                           day and 90-day oral toxicity study in                   Artichoke, Guava, Pomegranate,                        for cyprodinil. In estimating acute
                                           rats, treatment-related changes in                      Passionfruit, Feijoa, Jaboticaba, Wax                 dietary exposure, EPA used food
                                           thyroid weights or gross/microscopic                    Jambu, Starfruit, and Acerola and                     consumption information from the
                                           observations were not observed in the                   Amended Uses on Greenhouse                            United States Department of Agriculture
                                           chronic rat study or in other studies.                  Cucumbers and Small Tomatoes at                       (USDA) National Health and Nutrition
                                              A 28-day dietary immunotoxicity                      pages 36–40 in docket ID number EPA–                  Examination Survey, What We Eat in
                                           study in mice resulted in no apparent                   HQ–OPP–2014–0506.                                     America, (NHANES/WWEIA), from
                                           suppression of the humoral component                                                                          2003 to 2008. As to residue levels in
                                           of the immune system. The only effect                   B. Toxicological Points of Departure/                 food, EPA utilized tolerance-level
                                           attributed to cyprodinil treatment was                  Levels of Concern                                     residues and 100 percent crop treated
                                           higher liver weights at the highest dose                   Once a pesticide’s toxicological                   (PCT) for all commodities. The acute
                                           tested. There were no treatment-related                 profile is determined, EPA identifies                 assessment also incorporated Dietary
                                           effects on spleen or thymus weights; no                 toxicological points of departure (POD)               Exposure Evaluation Model software
                                           effects on specific activity or total                   and levels of concern to use in                       with the Food Commodity Intake
                                           activity of splenic immunoglobulin M                    evaluating the risk posed by human                    Database (DEEM–FCID) Version 3.18
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                                           (IgM) antibody-forming cells to the T                   exposure to the pesticide. For hazards                default processing factors; and empirical
                                           cell-dependent antigen sheep red blood                  that have a threshold below which there               processing factors for tomato paste/
                                           cells (sRBC).                                           is no appreciable risk, the toxicological             tomato puree and lemon/lime juice,
                                              An acute neurotoxicity study                         POD is used as the basis for derivation               where 1X empirical processing factors
                                           indicated systemic toxicity with signs of               of reference values for risk assessment.              were used to modify the tolerance
                                           induced hunched posture, pilorection,                   PODs are developed based on a careful                 values.


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                                                        Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations                                         54245

                                             ii. Chronic exposure. In conducting                   Concentration in Ground Water (SCI–                   other substances. For information
                                           the chronic dietary exposure assessment                 GROW), and Pesticide Root Zone Model                  regarding EPA’s efforts to determine
                                           EPA used the food consumption data                      for Groundwater (PRZM–GW) models,                     which chemicals have a common
                                           from the USDA NHANES/WWEIA. As                          the EDWCs of cyprodinil and CGA                       mechanism of toxicity and to evaluate
                                           to residue levels in food, EPA utilized                 249287 for acute exposures are                        the cumulative effects of such
                                           average field trial residues for pome                   estimated to be 34.8 parts per billion                chemicals, see EPA’s Web site at
                                           fruit, head lettuce, leaf lettuce, spinach,             (ppb) for surface water and 2.05 ppb for              http://www.epa.gov/pesticides/
                                           tomato, and grape and tolerance-level                   ground water. EDWCs for chronic                       cumulative.
                                           residues for the remaining commodities.                 exposures for non-cancer assessments
                                                                                                                                                         D. Safety Factor for Infants and
                                           The Agency also assumed 100 PCT. The                    are estimated to be 24.7 ppb for surface
                                                                                                                                                         Children
                                           chronic assessment also incorporated                    water and 1.80 ppb for ground water.
                                           DEEM default processing factors except                     Modeled estimates of drinking water                   1. In general. Section 408(b)(2)(C) of
                                           for tomato paste/tomato puree and                       concentrations were directly entered                  FFDCA provides that EPA shall apply
                                           lemon juice/lime juice, where a 1X                      into the dietary exposure model. The                  an additional tenfold (10X) margin of
                                           empirical processing factor was used to                 water concentration values of 34.8 ppb                safety for infants and children in the
                                           modify the tolerance values.                            and 24.7 ppb were used to assess the                  case of threshold effects to account for
                                             iii. Cancer. Based on the data                        contribution to drinking water for the                prenatal and postnatal toxicity and the
                                           summarized in Unit III.A., EPA has                      acute and chronic dietary risk                        completeness of the database on toxicity
                                           concluded that cyprodinil does not pose                 assessments, respectively.                            and exposure unless EPA determines
                                           a cancer risk to humans. Therefore, a                      3. From non-dietary exposure. The                  based on reliable data that a different
                                           dietary exposure assessment for the                     term ‘‘residential exposure’’ is used in              margin of safety will be safe for infants
                                           purpose of assessing cancer risk is                     this document to refer to non-                        and children. This additional margin of
                                           unnecessary.                                            occupational, non-dietary exposure                    safety is commonly referred to as the
                                              iv. Anticipated residue and PCT                      (e.g., for lawn and garden pest control,              FQPA Safety Factor (SF). In applying
                                           information. Section 408(b)(2)(E) of                    indoor pest control, termiticides, and                this provision, EPA either retains the
                                           FFDCA authorizes EPA to use available                   flea and tick control on pets).                       default value of 10X, or uses a different
                                           data and information on the anticipated                    Cyprodinil is currently registered for             additional safety factor when reliable
                                           residue levels of pesticide residues in                 the following uses that could result in               data available to EPA support the choice
                                           food and the actual levels of pesticide                 residential exposures: Ornamental                     of a different factor.
                                           residues that have been measured in                     landscapes. EPA assessed residential                     2. Prenatal and postnatal sensitivity.
                                           food. If EPA relies on such information,                exposure using the following                          In a rat developmental toxicity study,
                                           EPA must require pursuant to FFDCA                      assumptions: Short-term inhalation                    there were significantly lower mean
                                           section 408(f)(1) that data be provided 5               exposures to adult residential handlers               fetal weights in the high dose group
                                           years after the tolerance is established,               from the application of cyprodinil to                 compared to controls as well as a
                                           modified, or left in effect, demonstrating              ornamental landscapes. The residential                significant increase in skeletal
                                           that the levels in food are not above the               handler exposure scenarios were                       anomalies in the high dose group due to
                                           levels anticipated. For the present                     considered to be short-term only, due to              abnormal ossification. The skeletal
                                           action, EPA will issue such data call-ins               the infrequent use patterns associated                anomalies or variations were considered
                                           as are required by FFDCA section                        with homeowner products. Dermal                       to be a transient developmental delay
                                           408(b)(2)(E) and authorized under                       exposures were not assessed since there               that occurred secondary to the maternal
                                           FFDCA section 408(f)(1). Data will be                   was no dermal endpoint identified for                 toxicity noted in the high dose group. In
                                           required to be submitted no later than                  cyprodinil. Postapplication exposures to              the rabbit study, the only treatment-
                                           5 years from the date of issuance of                    adults or children were not expected                  related developmental effect was the
                                           these tolerances.                                       and were not assessed. Further                        indication of an increased incidence of
                                              2. Dietary exposure from drinking                    information regarding EPA standard                    a 13th rib at maternally toxic doses.
                                           water. The residues of concern in                       assumptions and generic inputs for                    Signs of fetal effects in the reproductive
                                           drinking water for risk assessment                      residential exposures may be found at                 toxicity study included significantly
                                           purposes are cyprodinil and the                         http://www.epa.gov/pesticides/science/                lower F1 and F2 pup weights in the
                                           degradate CGA 249287. The estimated                     residential-exposure-sop.html.                        high dose group during lactation, which
                                           drinking water concentrations (EDWCs)                      4. Cumulative effects from substances              continued to be lower than controls
                                           for each of these was calculated using a                with a common mechanism of toxicity.                  post-weaning and after the pre-mating
                                           molecular weight conversion and then                    Section 408(b)(2)(D)(v) of FFDCA                      period in the F1 generation.
                                           combined for each modeled scenario.                     requires that, when considering whether               Reproductive effects were seen only at
                                           The Agency used screening level water                   to establish, modify, or revoke a                     doses that also caused parental toxicity.
                                           exposure models in the dietary exposure                 tolerance, the Agency consider                           3. Conclusion. EPA has determined
                                           analysis and risk assessment for                        ‘‘available information’’ concerning the              that reliable data show the safety of
                                           cyprodinil and CGA 249287 in drinking                   cumulative effects of a particular                    infants and children would be
                                           water. These simulation models take                     pesticide’s residues and ‘‘other                      adequately protected if the FQPA SF
                                           into account data on the physical,                      substances that have a common                         were reduced to 1X for non-inhalation
                                           chemical, and fate/transport                            mechanism of toxicity.’’                              exposure scenarios. For inhalation
                                           characteristics of cyprodinil and CGA                      EPA has not found cyprodinil to share              exposure scenarios for all population
                                           249287. Further information regarding                   a common mechanism of toxicity with                   groups, EPA is retaining a 10X FQPA
                                           EPA drinking water models used in                       any other substances, and cyprodinil                  SF. That decision is based on the
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                                           pesticide exposure assessment can be                    does not appear to produce a toxic                    following findings:
                                           found at http://www.epa.gov/oppefed1/                   metabolite produced by other                             i. The toxicity database for cyprodinil
                                           models/water/index.htm.                                 substances. For the purposes of this                  is complete, except for a 90-day
                                              Based on the Pesticide Root Zone                     tolerance action, therefore, EPA has                  inhalation toxicity study. In the absence
                                           Model/Exposure Analysis Modeling                        assumed that cyprodinil does not have                 of a route-specific inhalation study, EPA
                                           System (PRZM/EXAMS), Screening                          a common mechanism of toxicity with                   is relying on the 28-day feeding/range-


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                                           54246        Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations

                                           finding rat oral study to estimate risk                 underestimate the exposure and risks                  registered for any use patterns that
                                           from inhalation exposures. EPA has                      posed by cyprodinil.                                  would result in intermediate-term
                                           determined that the use of this study to                                                                      residential exposure. Intermediate-term
                                                                                                   E. Aggregate Risks and Determination of
                                           extrapolate an inhalation endpoint may                                                                        risk is assessed based on intermediate-
                                                                                                   Safety
                                           understate risk. Accordingly, to address                                                                      term residential exposure plus chronic
                                           this uncertainty, EPA has concluded                        EPA determines whether acute and                   dietary exposure. Because there is no
                                           that the 10X FQPA SF should be                          chronic dietary pesticide exposures are               intermediate-term residential exposure
                                           retained for risk assessments involving                 safe by comparing aggregate exposure                  and chronic dietary exposure has
                                           inhalation exposure.                                    estimates to the acute PAD (aPAD) and                 already been assessed under the
                                              ii. As to evidence of neurotoxicity, in              chronic PAD (cPAD). For linear cancer                 appropriately protective cPAD (which is
                                           an acute neurotoxicity study in rats                    risks, EPA calculates the lifetime                    at least as protective as the POD used to
                                           clinical signs, hypothermia, and                        probability of acquiring cancer given the             assess intermediate-term risk), no
                                           changes in motor activity were all found                estimated aggregate exposure. Short-,                 further assessment of intermediate-term
                                           to be reversible and no longer seen at                  intermediate-, and chronic-term risks                 risk is necessary, and EPA relies on the
                                           day 8 and 15 investigations. There were                 are evaluated by comparing the                        chronic dietary risk assessment for
                                           no treatment-related effects on mortality               estimated aggregate food, water, and                  evaluating intermediate-term risk for
                                           or gross or histological neuropathology.                residential exposure to the appropriate               cyprodinil.
                                           Reduced motor activity, induced                         PODs to ensure that an adequate MOE                      5. Aggregate cancer risk for U.S.
                                           hunched posture, piloerection and                       exists.                                               population. Based on the lack of
                                           reduced responsiveness to sensory                          1. Acute risk. Using the exposure                  evidence of carcinogenicity in two
                                           stimuli were observed and disappeared                   assumptions discussed in this unit for                adequate rodent carcinogenicity studies,
                                           in all animals by day three to four. For                acute exposure, the acute dietary                     cyprodinil is not expected to pose a
                                           the subchronic neurotoxicity study in                   exposure from food and water to                       cancer risk to humans.
                                           rats, there was no indication that                      cyprodinil will occupy 8.6% of the                       6. Determination of safety. Based on
                                           cyprodinil is a neurotoxic chemical.                    aPAD for children one to two years old,               these risk assessments, EPA concludes
                                           Based on this evidence, there is no need                the population group receiving the                    that there is a reasonable certainty that
                                           for a developmental neurotoxicity study                 greatest exposure.                                    no harm will result to the general
                                           or additional UFs to account for                           2. Chronic risk. Using the exposure
                                                                                                                                                         population, or to infants and children
                                           neurotoxicity.                                          assumptions described in this unit for
                                                                                                                                                         from aggregate exposure to cyprodinil
                                              iii. When toxicity was observed in the               chronic exposure, EPA has concluded
                                                                                                                                                         residues.
                                           prenatal developmental toxicity studies                 that chronic exposure to cyprodinil
                                           in rats and rabbits and the two-                        from food and water will utilize 85% of               IV. Other Considerations
                                           generation reproduction study in rats,                  the cPAD for children one to two years
                                                                                                                                                         A. Analytical Enforcement Methodology
                                           toxicity to the fetuses or offspring                    old, the population group receiving the
                                           occurred at the same doses at which                     greatest exposure. Based on the                          Adequate high performance liquid
                                           effects were observed in maternal/                      explanation in Unit III.C.3., regarding               chromatography, using ultra-violet
                                           parental animals. Additionally, the                     residential use patterns, chronic                     detection (HPLC/UV) methods (Methods
                                           skeletal anomalies or variations were                   residential exposure to residues of                   AG–631 and AG–631B) are available to
                                           considered to be a transient                            cyprodinil is not expected.                           enforce the tolerance expression of
                                           developmental delay that occurred                          3. Short-term risk. Short-term                     cyprodinil in/on plant commodities.
                                           secondary to the maternal toxicity noted                aggregate exposure takes into account                    The methods may be requested from:
                                           in the high dose group. Therefore, there                short-term residential exposure plus                  Chief, Analytical Chemistry Branch,
                                           is no evidence that cyprodinil results in               chronic exposure to food and water                    Environmental Science Center, 701
                                           increased susceptibility in in utero rats               (considered to be a background                        Mapes Rd., Ft. Meade, MD 20755–5350;
                                           or rabbits in the prenatal developmental                exposure level). Cyprodinil is currently              telephone number: (410) 305–2905;
                                           studies or in young rats in the two-                    registered for uses that could result in              email address: residuemethods@
                                           generation reproduction study.                          short-term residential exposure, and the              epa.gov.
                                              iv. There are no residual uncertainties              Agency has determined that it is
                                                                                                                                                         B. International Residue Limits
                                           identified in the exposure databases.                   appropriate to aggregate chronic
                                           The acute dietary assessment was                        exposure through food and water with                    In making its tolerance decisions, EPA
                                           conservative and based upon 100 PCT                     short-term residential exposures to                   seeks to harmonize U.S. tolerances with
                                           and tolerance-level residues, as well as                cyprodinil.                                           international standards whenever
                                           DEEM default and empirical processing                      Using the exposure assumptions                     possible, consistent with U.S. food
                                           factors. The chronic dietary assessment                 described in this unit for short-term                 safety standards and agricultural
                                           was partially refined with average field                exposures, EPA has concluded the                      practices. EPA considers the
                                           trial residues for some commodities and                 combined short-term food, water, and                  international maximum residue limits
                                           tolerance-level residues for the                        residential exposures result in an                    (MRLs) established by the Codex
                                           remaining commodities. DEEM default                     aggregate MOE of 7,900. Because EPA’s                 Alimentarius Commission (Codex), as
                                           and empirical processing factors were                   level of concern for cyprodinil is a MOE              required by FFDCA section 408(b)(4).
                                           also incorporated into the chronic                      of 1,000 or below, these MOEs are not                 The Codex Alimentarius is a joint
                                           dietary assessment. EPA made                            of concern.                                           United Nations Food and Agriculture
                                           conservative (protective) assumptions in                   4. Intermediate-term risk.                         Organization/World Health
                                           the ground and surface water modeling                   Intermediate-term aggregate exposure                  Organization food standards program,
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                                           used to assess exposure to cyprodinil in                takes into account intermediate-term                  and it is recognized as an international
                                           drinking water. Based on the discussion                 residential exposure plus chronic                     food safety standards-setting
                                           in Unit III.C.3, postapplication exposure               exposure to food and water (considered                organization in trade agreements to
                                           of children as well as incidental oral                  to be a background exposure level). An                which the United States is a party. EPA
                                           exposure of toddlers is not expected.                   intermediate-term adverse effect was                  may establish a tolerance that is
                                           These assessments will not                              identified; however, cyprodinil is not                different from a Codex MRL; however,


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                                                        Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations                                              54247

                                           FFDCA section 408(b)(4) requires that                   order to provide the correct commodity                section 408(n)(4). As such, the Agency
                                           EPA explain the reasons for departing                   definition.                                           has determined that this action will not
                                           from the Codex level.                                                                                         have a substantial direct effect on States
                                                                                                   V. Conclusion
                                              The Codex has established MRLs for                                                                         or tribal governments, on the
                                           cyprodinil in or on stone fruit at 2.0                     Therefore, tolerances are established              relationship between the national
                                           ppm. This MRL is the same as the                        for residues of cyprodinil, 4-                        government and the States or tribal
                                           tolerance established for cyprodinil in                 cyclopropyl-6-methyl-N-phenyl-2-                      governments, or on the distribution of
                                           the United States for fruit, stone, group               pyrimidinamine, in or on acerola at 1.5               power and responsibilities among the
                                           12–12. The Codex has not established a                  ppm; artichoke, globe at 4.0 ppm; feijoa              various levels of government or between
                                           MRL for cyprodinil in or on the other                   at 1.5 ppm; fruit, stone, group 12–12 at              the Federal Government and Indian
                                           commodities associated with this                        2.0 ppm; guava at 1.5 ppm; jaboticaba at              tribes. Thus, the Agency has determined
                                           action.                                                 1.5 ppm; passionfruit at 1.5 ppm;                     that Executive Order 13132, entitled
                                                                                                   pomegranate at 10 ppm; starfruit at 1.5               ‘‘Federalism’’ (64 FR 43255, August 10,
                                           C. Response to Comments                                 ppm; and wax jambu at 1.5 ppm.                        1999) and Executive Order 13175,
                                              Several comments were received in                    Additionally, this action removes the                 entitled ‘‘Consultation and Coordination
                                           response to the notice of filing. All but               tolerance established in or on fruit,                 with Indian Tribal Governments’’ (65 FR
                                           one were concerned with potential                       stone, group 12 at 2.0 ppm as that crop               67249, November 9, 2000) do not apply
                                           environmental impacts, and were not                     group tolerance is superseded by the                  to this action. In addition, this action
                                                                                                   tolerance being established in this                   does not impose any enforceable duty or
                                           specifically related to the cyprodinil
                                                                                                   action for crop group 12–12.                          contain any unfunded mandate as
                                           action. EPA notes that these comments
                                           address potential environmental                         VI. Statutory and Executive Order                     described under Title II of the Unfunded
                                           concerns; however, the safety standard                  Reviews                                               Mandates Reform Act (UMRA) (2 U.S.C.
                                           for approving tolerances under section                     This action establishes tolerances                 1501 et seq.).
                                           408 of the FFDCA focuses on potential                   under FFDCA section 408(d) in                            This action does not involve any
                                           harms to human health and does not                      response to a petition submitted to the               technical standards that would require
                                           permit consideration of effects on the                  Agency. The Office of Management and                  Agency consideration of voluntary
                                           environment.                                            Budget (OMB) has exempted these types                 consensus standards pursuant to section
                                              One additional comment was received                  of actions from review under Executive                12(d) of the National Technology
                                           that did not specifically address the                   Order 12866, entitled ‘‘Regulatory                    Transfer and Advancement Act
                                           cyprodinil action, but that raised                      Planning and Review’’ (58 FR 51735,                   (NTTAA) (15 U.S.C. 272 note).
                                           concerns about the toxicity of pesticides               October 4, 1993). Because this action                 VII. Congressional Review Act
                                           and requested that no tolerance be                      has been exempted from review under
                                           established. The Agency understands                     Executive Order 12866, this action is                   Pursuant to the Congressional Review
                                           the commenter’s concerns and                            not subject to Executive Order 13211,                 Act (5 U.S.C. 801 et seq.), EPA will
                                           recognizes that some individuals believe                entitled ‘‘Actions Concerning                         submit a report containing this rule and
                                           that pesticides should be banned on                     Regulations That Significantly Affect                 other required information to the U.S.
                                           agricultural crops. However, the existing               Energy Supply, Distribution, or Use’’ (66             Senate, the U.S. House of
                                           legal framework provided by section                     FR 28355, May 22, 2001) or Executive                  Representatives, and the Comptroller
                                           408 of the FFDCA states that tolerances                 Order 13045, entitled ‘‘Protection of                 General of the United States prior to
                                           may be set when persons seeking such                    Children from Environmental Health                    publication of the rule in the Federal
                                           tolerances or exemptions have                           Risks and Safety Risks’’ (62 FR 19885,                Register. This action is not a ‘‘major
                                           demonstrated that the pesticide meets                   April 23, 1997). This action does not                 rule’’ as defined by 5 U.S.C. 804(2).
                                           the safety standard imposed by that                     contain any information collections
                                           statute. This citizen’s comment appears                                                                       List of Subjects in 40 CFR Part 180
                                                                                                   subject to OMB approval under the
                                           to be directed at the underlying statute                Paperwork Reduction Act (PRA) (44                       Environmental protection,
                                           and not EPA’s implementation of it; the                 U.S.C. 3501 et seq.), nor does it require             Administrative practice and procedure,
                                           citizen has made no contention that                     any special considerations under                      Agricultural commodities, Pesticides
                                           EPA has acted in violation of the                       Executive Order 12898, entitled                       and pests, Reporting and recordkeeping
                                           statutory framework. EPA has found                      ‘‘Federal Actions to Address                          requirements.
                                           that there is a reasonable certainty of no              Environmental Justice in Minority                       Dated: August 13, 2015.
                                           harm to humans after considering the                    Populations and Low-Income
                                           toxicological studies and the exposure                                                                        Susan Lewis,
                                                                                                   Populations’’ (59 FR 7629, February 16,
                                           levels of humans to cyprodinil.                         1994).                                                Director, Registration Division, Office of
                                                                                                                                                         Pesticide Programs.
                                           D. Revisions to Petitioned-For                             Since tolerances and exemptions that
                                           Tolerances                                              are established on the basis of a petition              Therefore, 40 CFR chapter I is
                                                                                                   under FFDCA section 408(d), such as                   amended as follows:
                                             Based on the data submitted with the                  the tolerances in this final rule, do not
                                           petition, EPA has determined that the                   require the issuance of a proposed rule,              PART 180—[AMENDED]
                                           proposed tolerance in or on                             the requirements of the Regulatory
                                           pomegranate at 7.0 ppm should be                        Flexibility Act (RFA) (5 U.S.C. 601 et                ■ 1. The authority citation for part 180
                                           established at 10 ppm. This tolerance                   seq.), do not apply.                                  continues to read as follows:
                                           level was determined by the                                This action directly regulates growers,
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                                                                                                                                                             Authority: 21 U.S.C. 321(q), 346a and 371.
                                           Organization for Economic Cooperation                   food processors, food handlers, and food
                                           and Development tolerance calculation                   retailers, not States or tribes, nor does             ■  2. In § 180.532, remove the entry,
                                           procedures. Additionally, the Agency is                 this action alter the relationships or                ‘‘Fruit, stone, group 12’’ and
                                           establishing a tolerance in or on                       distribution of power and                             alphabetically add the following
                                           artichoke, globe, rather than the                       responsibilities established by Congress              commodities to the table in paragraph
                                           petitioned-for commodity artichoke in                   in the preemption provisions of FFDCA                 (a) to read as follows:


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                                           54248             Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations

                                           § 180.532 Cyprodinil; tolerances for                                   requests for hearings must be received               C. How can I file an objection or hearing
                                           residues.                                                              on or before November 9, 2015, and                   request?
                                               (a) * * *                                                          must be filed in accordance with the                   Under FFDCA section 408(g), 21
                                                                                                                  instructions provided in 40 CFR part                 U.S.C. 346a, any person may file an
                                                                                               Parts per          178 (see also Unit I.C. of the
                                                          Commodity                                                                                                    objection to any aspect of this regulation
                                                                                                million
                                                                                                                  SUPPLEMENTARY INFORMATION).                          and may also request a hearing on those
                                           Acerola ........................................                 1.5   ADDRESSES:    The docket for this action,            objections. You must file your objection
                                                                                                                  identified by docket identification (ID)             or request a hearing on this regulation
                                               *         *           *               *                  *                                                              in accordance with the instructions
                                           Artichoke, globe ..........................                      4.0   number EPA–HQ–OPP–2015–0143, is
                                                                                                                  available at http://www.regulations.gov              provided in 40 CFR part 178. To ensure
                                              *             *              *               *            *         or at the Office of Pesticide Programs               proper receipt by EPA, you must
                                           Feijoa ..........................................                1.5   Regulatory Public Docket (OPP Docket)                identify docket ID number EPA–HQ–
                                                                                                                  in the Environmental Protection Agency               OPP–2015–0143 in the subject line on
                                              *          *        *            *                        *
                                                                                                                  Docket Center (EPA/DC), West William                 the first page of your submission. All
                                           Fruit, stone, group 12–12 ...........                            2.0                                                        objections and requests for a hearing
                                                                                                                  Jefferson Clinton Bldg., Rm. 3334, 1301
                                                                                                                                                                       must be in writing, and must be
                                             *            *              *               *              *         Constitution Ave. NW., Washington, DC
                                                                                                                                                                       received by the Hearing Clerk on or
                                           Guava .........................................                  1.5   20460–0001. The Public Reading Room
                                                                                                                                                                       before November 9, 2015. Addresses for
                                                                                                                  is open from 8:30 a.m. to 4:30 p.m.,
                                              *         *              *               *                *                                                              mail and hand delivery of objections
                                                                                                                  Monday through Friday, excluding legal
                                           Jaboticaba ..................................                    1.5                                                        and hearing requests are provided in 40
                                                                                                                  holidays. The telephone number for the
                                                                                                                                                                       CFR 178.25(b).
                                              *          *              *               *               *         Public Reading Room is (202) 566–1744,                 In addition to filing an objection or
                                           Passionfruit .................................                   1.5   and the telephone number for the OPP                 hearing request with the Hearing Clerk
                                                                                                                  Docket is (703) 305–5805. Please review              as described in 40 CFR part 178, please
                                             *        *             *               *                   *         the visitor instructions and additional              submit a copy of the filing (excluding
                                           Pomegranate ..............................                       10    information about the docket available               any Confidential Business Information
                                                                                                                  at http://www.epa.gov/dockets.                       (CBI)) for inclusion in the public docket.
                                              *             *              *               *            *
                                           Starfruit .......................................                1.5   FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                       Information not marked confidential
                                                                                                                  Susan Lewis, Registration Division                   pursuant to 40 CFR part 2 may be
                                             *         *              *               *                 *                                                              disclosed publicly by EPA without prior
                                           Wax jambu ..................................                     1.5   (7505P), Office of Pesticide Programs,
                                                                                                                                                                       notice. Submit the non-CBI copy of your
                                                                                                                  Environmental Protection Agency, 1200
                                                                                                                                                                       objection or hearing request, identified
                                           *        *        *        *         *                                 Pennsylvania Ave. NW., Washington,
                                                                                                                                                                       by docket ID number EPA–HQ–OPP–
                                           [FR Doc. 2015–22031 Filed 9–8–15; 8:45 am]                             DC 20460–0001; main telephone
                                                                                                                                                                       2015–0143, by one of the following
                                           BILLING CODE 6560–50–P                                                 number: (703) 305–7090; email address:
                                                                                                                                                                       methods:
                                                                                                                  RDFRNotices@epa.gov.                                   • Federal eRulemaking Portal: http://
                                                                                                                  SUPPLEMENTARY INFORMATION:                           www.regulations.gov. Follow the online
                                           ENVIRONMENTAL PROTECTION
                                                                                                                                                                       instructions for submitting comments.
                                           AGENCY                                                                 I. General Information                               Do not submit electronically any
                                           40 CFR Part 180                                                        A. Does this action apply to me?                     information you consider to be CBI or
                                                                                                                                                                       other information whose disclosure is
                                           [EPA–HQ–OPP–2015–0143; FRL–9932–06]                                       You may be potentially affected by                restricted by statute.
                                                                                                                  this action if you are an agricultural                 • Mail: OPP Docket, Environmental
                                           Propylene Glycol Monomethyl Ether;                                                                                          Protection Agency Docket Center (EPA/
                                                                                                                  producer, food manufacturer, or
                                           Exemption from the Requirement of a                                                                                         DC), (28221T), 1200 Pennsylvania Ave.
                                           Tolerance                                                              pesticide manufacturer. The following
                                                                                                                  list of North American Industrial                    NW., Washington, DC 20460–0001.
                                           AGENCY:  Environmental Protection                                      Classification System (NAICS) codes is                 • Hand Delivery: To make special
                                           Agency (EPA).                                                          not intended to be exhaustive, but rather            arrangements for hand delivery or
                                           ACTION: Final rule.                                                    provides a guide to help readers                     delivery of boxed information, please
                                                                                                                  determine whether this document                      follow the instructions at http://
                                           SUMMARY:   This regulation establishes an                              applies to them. Potentially affected                www.epa.gov/dockets/contacts.html.
                                           exemption from the requirement of a                                    entities may include:                                Additional instructions on commenting
                                           tolerance for residues of propylene                                                                                         or visiting the docket, along with more
                                           glycol monomethyl ether (PGME; CAS                                       • Crop production (NAICS code 111).
                                                                                                                                                                       information about dockets generally, is
                                           No. 107–98–2) when used as an inert                                      • Animal production (NAICS code 112).
                                                                                                                                                                       available at http://www.epa.gov/
                                           ingredient under 40 CFR 180.910 as a                                     • Food manufacturing (NAICS code 311).
                                                                                                                    • Pesticide manufacturing (NAICS code
                                                                                                                                                                       dockets.
                                           solvent in pesticide formulations which
                                           include pre-and post–harvest use on                                    32532).                                              II. Petition for Exemption
                                           crops. Syngenta Crop Protection                                        B. How can I get electronic access to                  In the Federal Register of April 6,
                                           submitted a petition to EPA under the                                  other related information?                           2015 (80 FR 18327) (FRL–9924–00),
                                           Federal Food, Drug, and Cosmetic Act                                                                                        EPA issued a document pursuant to
                                           (FFDCA), requesting establishment of an                                  You may access a frequently updated                FFDCA section 408, 21 U.S.C. 346a,
Lhorne on DSK5TPTVN1PROD with RULES




                                           exemption from the requirement of a                                    electronic version of 40 CFR part 180                announcing the filing of a pesticide
                                           tolerance. This regulation eliminates the                              through the Government Printing                      petition inert ingredient (PP IN–10775)
                                           need to establish a maximum                                            Office’s e-CFR site at http://                       by Syngenta Crop Protection, P.O. Box
                                           permissible level for residues of PGME.                                www.ecfr.gov/cgi-bin/text-                           18300, Greensboro, NC 27409, The
                                           DATES: This regulation is effective                                    idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                 petition requested that 40 CFR 180.910
                                           September 9, 2015. Objections and                                      40tab_02.tpl.                                        be amended by establishing an


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Document Created: 2015-12-15 09:53:20
Document Modified: 2015-12-15 09:53:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective September 9, 2015. Objections and requests for hearings must be received on or before November 9, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation80 FR 54242 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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