[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Rules and Regulations]
[Pages 53316-53322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21542]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0286; FRL-9999-57]


Cyromazine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyromazine in or on multiple commodities which are identified and 
discussed later in this document. The Interregional Research Project 
Number 4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

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

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2018-0286, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under 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-2018-0286 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing and must be received by the Hearing Clerk on or before 
December 6, 2019. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2018-0286, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets. Additional instructions on commenting or visiting the docket, 
along with more information about dockets generally, is available at 
http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 24, 2018 (83 FR 34968) (FRL-9980-
31), 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 
8E8673) by The Interregional Research Project Number 4 (IR-4), Rutgers, 
The State University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.414 be 
amended by establishing tolerances for residues of the insecticide 
cyromazine, N-cyclopropyl-1,3,5-triazine-2,4,6-triamine, in or on 
Brassica, leafy greens, subgroup 4-16B

[[Page 53317]]

at 10.0 parts per million (ppm); Celtuce at 7.0 ppm; Chickpea, edible 
podded at 0.4 ppm; Chickpea, succulent shelled at 0.3 ppm; Dwarf pea, 
edible podded at 0.4 ppm; Edible podded pea, edible podded at 0.4 ppm; 
English pea, succulent shelled at 0.3 ppm; Florence fennel at 7.0 ppm; 
Garden pea, succulent shelled at 0.3 ppm; Grass-pea, edible podded at 
0.4 ppm; Green pea, edible podded at 0.4 ppm; Green pea, succulent 
shelled at 0.3 ppm; Kohlrabi at 10.0 ppm; Leaf petiole subgroup 22B at 
7.0 ppm; Leafy green subgroup 4-16A at 7.0 ppm; Lentil, edible podded 
at 0.4 ppm; Lentil, succulent shelled at 0.3 ppm; Onion, bulb, subgroup 
3-07A at 0.2 ppm; Onion, green, subgroup 3-07B at 3.0 ppm; Pepper/
eggplant 8-10B at 1.0 ppm; Pigeon pea, edible podded at 0.4 ppm; Pigeon 
pea, succulent shelled at 0.3 ppm; Snap pea, edible podded at 0.4 ppm; 
Snow pea, edible podded at 0.4 ppm; Sugar snap pea, edible podded at 
0.4 ppm; Tomato subgroup 8-10A at 1.0 ppm; Vegetable, brassica, head 
and stem, group 5-16, except broccoli at 10.0 ppm; and Vegetable, 
tuberous and corm, subgroup 1C at 0.8 ppm.
    Upon establishing those tolerances, the petition also proposed to 
remove existing tolerances for residues of cyromazine (N-cyclopropyl-
1,3,5-triazine-2,4,6-triamine) in or on cabbage, abyssinian at 10.0 
ppm; cabbage, seakale at 10.0 ppm; garlic at 0.2 ppm; garlic, great-
headed, bulb at 0.2 ppm; Hanover salad, leaves at 10.0 ppm; leek at 3.0 
ppm; onion, bulb at 0.2 ppm; onion, green at 3.0 ppm; onion, potato at 
3.0 ppm; onion, tree at 3.0 ppm; onion, welsh at 3.0 ppm; pepper at 1.0 
ppm; potato at 0.8 ppm; rakkyo, bulb at 0.2 ppm; shallot, bulb at 0.2 
ppm; shallot, fresh leaves at 3.0 ppm; tomato at 0.5 ppm; turnip, 
greens at 10.0 ppm; vegetable, brassica, leafy, group 5, except 
broccoli at 10.0; vegetable, leafy, except brassica, group 4 at 7.0 
ppm. That document referenced a summary of the petition prepared by 
Makhteshim Agan of North American, Inc., (ADAMA) and Syngenta Crop 
Protection, LLC, the registrants, which is available in the docket, 
http://www.regulations.gov. Three 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 
corrected the terminology for several commodities and is establishing 
tolerances at levels other than petitioned for on some of the 
commodities. 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, aggregate exposure for cyromazine including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with cyromazine 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.
    No specific toxicity was associated with cyromazine, with lowest 
observed adverse effects levels (LOAELs) occurring at relatively high 
doses. Decreases in body weight and food consumption are the common 
features of cyromazine toxicity following subchronic or chronic oral 
exposures as seen in dogs, rats, mice, and rabbits. Other effects 
reported were organ weight (relative) changes and changes to some 
hematological parameters that were biologically insignificant and non-
adverse. No dermal or systemic toxicity was seen at the highest dose 
tested (greater than 2,000 mg/kg/day) in two 21-day dermal toxicity 
studies in rabbits. In a 28-day inhalation study in rats, cyromazine 
produced clinical signs of toxicity (hunched posture, piloerection, and 
reduced spontaneous activity) consistent with dyspnea at all 
concentrations tested. An acute neurotoxicity study demonstrated 
reduced motor activity as the main effect with no treatment-related 
effects on mortality, brain weight, or gross and histologic pathology 
or neuropathology up to the limit dose tested.
    There is no evidence of developmental toxicity following in utero 
exposures or that offspring are more susceptible following postnatal 
exposure. In the 2-generation reproduction study in rats no 
reproductive effects were observed. The available oral perinatal, 
prenatal and postnatal data demonstrated no indication of increased 
sensitivity of rats or rabbits to in utero exposure to cyromazine. No 
quantitative or qualitative susceptibility was observed in any study. 
In the prenatal developmental rat toxicity study, the NOAEL (300 mg/kg/
day) for developmental effects (increased incidence of minor skeletal 
variations) was higher than the maternal NOAEL (100 mg/kg/day). In the 
developmental toxicity study in rabbits, no evidence of developmental 
toxicity was noted since the NOAEL was the highest dose tested (60 mg/
kg/day). In the 2-generation reproduction rat study, no reproductive 
effects were observed up to the highest dose tested (150 mg/kg/day).
    Cyromazine was not carcinogenic in mice or rats following long-term 
dietary administration and was classified ``Group E--Evidence of 
Noncarcinogenicity for Humans.'' The available mutagenicity data 
suggest that cyromazine does not have genotoxic activity. Cyromazine is 
categorized as Toxicity Category III for acute oral, dermal and 
inhalation toxicity. Cyromazine is neither an eye irritant nor a dermal 
sensitizer; however, it is mild skin irritant.
    Specific information on the studies received and the nature of the 
adverse effects caused by cyromazine 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 ``Cyromazine: Human health Risk 
Assessment for Proposed New Foliar Uses on Edible Podded pea and 
Succulent Shelled Pea Commodities, Crop Group Conversion on Leafy green 
subgroup 4-16A, Leaf petiole subgroup 22B, Celtuce, and Florence 
fennel; Vegetable, brassica, head and stem,

[[Page 53318]]

group 5-16, except broccoli; Brassica, leafy greens, subgroup 4-16B; 
Kohlrabi; Hanover salad, leaves; Turnip, greens; Cabbage, Abyssinian; 
and Cabbage, seakale; Tomato subgroup 8-10A; Pepper/eggplant subgroup 
8-10B; and Expansion of Vegetable, tuberous ad corm, subgroup 1C, 
Onion, bulb, subgroup 3-07A; and Onion, green, subgroup 3-07B'' at page 
number 11 and ``Cyromazine: Human Health Risk Assessment for 
Registration Review'' at pages 51-53 in docket ID number EPA-HQ-OPP-
2018-0286.

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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    A summary of the toxicological endpoints for cyromazine used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Cyromazine for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13+ years   No developmental effects attributable to a single dose were seen following in
 of age).                           utero exposures to rats and rabbits.
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..  LOAEL = 250 mg/kg/    Acute RfD = 2.5 mg/  Acute Neurotoxicity Study in rats.
                                    day.                  kg/day.             LOAEL = 250 mg/kg/day based on
                                   UFA = 10x...........  aPAD = 0.83 mg/kg/    decreased motor activity (mean
                                   UFH = 10x...........   day.                 cumulative ambulatory LMA counts,
                                   FQPA SF = 3x........                        44%) in males at the time of peak
                                                                               effect on Day 0, and decreased
                                                                               food consumption (17%) on Day 1.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 50 mg/kg/day  Chronic RfD = 0.5    Two-Generation Reproductive Study
                                   UFA = 10x...........   mg/kg/day.           in rats.
                                   UFH = 10x...........  cPAD = 0.5 mg/kg/    LOAEL = 150 mg/kg/day for
                                   FQPA SF = 1x........   day.                 decreased body weights (27%) that
                                                                               were associated with decreased
                                                                               food efficiency.
                                                                              Co-critical with:
                                                                              Chronic Carcinogenicity Study in
                                                                               the rat.
                                                                              LOAEL = 150 mg/kg/day based on
                                                                               decreased body weight (20% males,
                                                                               29% females) associated with
                                                                               lower food consumption (10-15%)
                                                                               compared to controls.
----------------------------------------------------------------------------------------------------------------
Cancer (All routes)..............  Group E--No evidence for carcinogenicity in humans.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-
  effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyromazine, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyromazine tolerances in 40 CFR 
180.414. EPA assessed dietary exposures from cyromazine 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 cyromazine. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA's) 2003-2008 National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, EPA used tolerance-level residues and 100% crop 
treated assumptions.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). As to residue levels in food, EPA used 
tolerance-level residues and 100% crop treated assumptions.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that cyromazine does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for cyromazine. Tolerance level residues and 100% CT 
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for cyromazine in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of cyromazine. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/pesticide-science-

[[Page 53319]]

and-assessing-pesticide-risks/about-water-exposure-models-used-
pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of cyromazine for acute exposures 
are estimated to be 47.1 parts per billion (ppb) for surface water and 
111 ppb for ground water. For chronic exposures for non-cancer 
assessments, EDWCs are estimated to be 15.8 ppb for surface water and 
86 ppb for ground water. Modeled estimates of drinking water 
concentrations were directly entered into the dietary exposure model. 
For acute dietary risk assessment, the water concentration value of 111 
ppb was used to assess the contribution to drinking water. For chronic 
dietary risk assessment, the water concentration value of 86 ppb was 
used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Cyromazine is not 
registered for any specific use patterns that would result in 
residential exposure. Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be found 
at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has determined that the 
available toxicological data suggests cyromazine does not share a 
similar toxicological profile, and thus no common mechanism of 
toxicity, with other pesticides. No further cumulative evaluation is 
necessary for cyromazine. This analysis can be found at http://www.regulations.gov in document ``Chitin Synthesis Inhibitors 
(Buprofezin and Cyromazine): Screening Analysis of Toxicological 
Profiles to Consider Whether a Candidate Common Mechanism Group Can Be 
Established'' in docket ID number EPA-HQ-OPP-2018-0286.

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. Based on the available data, 
there is no quantitative and qualitative evidence of increased 
susceptibility observed following in utero cyromazine exposure to rats 
and rabbits or following prenatal/postnatal exposure in the 2-
generation reproduction study. The database is considered adequate for 
selection of study endpoints and determination of a dose/response to 
characterize the potential prenatal or postnatal toxicity of cyromazine 
to infants and children. No increase in susceptibility was seen in 
developmental toxicity studies in rat and rabbit or reproductive 
toxicity studies in the rat. Toxicity to offspring was observed at dose 
levels the same or greater than those causing maternal or parental 
toxicity. Based on the results of developmental and reproductive 
toxicity studies, there is not a concern or increased qualitative and/
or quantitative susceptibility following in utero exposure to 
cyromazine.
    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 the chronic dietary exposure assessment 
and retained at 3X for the acute dietary exposure assessment. That 
decision is based on the following findings:
    i. The toxicity database for cyromazine is complete for assessing 
the risks to infants and children. However, the study providing the 
basis for the acute dietary exposure POD lacks a NOAEL, so the Agency 
is retaining a 3X FQPA SF for extrapolating a NOAEL.
    ii. There is no evidence of neurotoxicity in the cyromazine 
repeated dose studies, which include subchronic or chronic dosing in 
multiple species. However, in the acute neurotoxicity study conducted 
in rats, reduced motor activity was seen at all doses tested and 
additional neurological effects (decreased foot splay in males and 
increased rearing behavior in females) were observed at the highest 
dose tested. Because a NOAEL was not established for the acute 
neurotoxicity effects, an FQPA SF will be retained for the acute risk 
assessment. In this case, the default FQPA SF of 10X can be reduced to 
3X for the following reasons:
    (1) the toxicity database is considered complete for cyromazine and 
no other studies via the oral route showed clinical signs or 
histopathology indicative of neurotoxicity;
    (2) a 3X SF yields an acute PAD of 0.83 mg/kg/day, which is similar 
to the chronic PAD of 0.5 mg/kg/day. The chronic POD is considered very 
conservative and is based on 27% decreased body weight seen at the 
LOAEL of 150 mg/kg/day in absence of any other significant effects. The 
aPAD is conservative because it is unlikely that decreased motor 
activity would occur at doses similar to the chronic endpoint. The 
effects used to derive the chronic POD (decrease in body weight) were 
observed only after repeated exposure (15 weeks) and there was no 
indication of decreased activity or other neurological clinical signs 
in the chronic study; and
    (3) motor activity seems to be a very sensitive indicator of acute 
toxicity of cyromazine. While there are indications of neurotoxicity in 
the ACN and inhalation studies, the selected endpoints are protective 
of those effects, therefore there is no concern for developmental 
neurotoxicity resulting from exposure to cyromazine. Based on the 
findings in the acute neurotoxicity study and the total weight of 
evidence, the requirement for the subchronic neurotoxicity study was 
waived.
    iii. There is no evidence that cyromazine results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to cyromazine in drinking water. These assessments 
will not underestimate the exposure and risks posed by cyromazine.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure

[[Page 53320]]

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 cyromazine will occupy 18% of the aPAD for children 1 to 2 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
cyromazine from food and water will utilize 8.3% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. There are no residential uses for cyromazine that would 
result in chronic exposure.
    3. Short-term and Intermediate-term risk. Short- and intermediate-
term aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, cyromazine 
is not registered for any use patterns that would result in short- or 
intermediate-term residential exposure. Short- and intermediate-term 
risk is assessed based on short- and intermediate-term residential 
exposure plus chronic dietary exposure. Because there is no short- or 
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 short- or 
intermediate-term risk), no further assessment of short- or 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risk for cyromazine.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, cyromazine is not expected to pose a cancer risk to humans.
    5. 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 cyromazine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. Adequate methods are available in Pesticide 
Analytical Manual (PAM), Vol. II for enforcement of the established 
tolerances for cyromazine in/on plant commodities. The working method 
``Determination of Cyromazine in Bean (snap)'' Revision O, was derived 
from Ciba-Geigy Analytical Method No. AG0621, ``Analytical Method for 
the Determination of Cyromazine and its Metabolite Melamine residues in 
Crops by Gas Chromatography with a Nitrogen/Phosphorous detector in the 
Nitrogen Specific Mode. (January 12, 1995).'' Minor modifications were 
made to improve the performance of the method. The limit of 
quantitation for cyromazine is 0.05 ppm in most plant commodities. 
Adequate methods are available in PAM, Vol. II for enforcement of the 
established tolerances for cyromazine in/on meat, milk, poultry, and 
eggs. Cyromazine, per se, was recovered when analyzed through Protocol 
III (present Protocol D). The Agency concluded that the data were 
acceptable and no additional cyromazine multiresidue method (MRM) 
recovery data were required.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are Codex MRLs established for residues of cyromazine in/on 
several commodities. The U.S. tolerances being established for Onion, 
green, subgroup 3-07B and Tomato subgroup 8-10A are harmonized with 
Codex. The U.S. is not able to harmonize with Codex for Onion, bulb, 
subgroup 3-07A; Leafy green subgroup 4-16A; Leaf petiole subgroup 22B; 
Brassica, leafy greens, subgroup 4-16B; and pepper/eggplant subgroup 8-
10B because differences in use patterns and residues in submitted field 
trials support higher U.S. tolerances; harmonization would cause 
tolerance exceedances and violative residues, despite legal use of 
cyromazine pursuant to U.S. labels. There are no Codex MRLs for the 
other commodities in this action.

C. Response to Comments

    EPA received three comments to the Notice of Filing. Two comments 
expressed concerns about wildfires, health and habitats. These comments 
did not raise any issues related to the Agency's safety determination 
of cyromazine tolerances. The receipt of these comments is acknowledged 
however, these comments are not relevant to this action. Another 
commenter stated the following, ``In rule making, please use the 
following standard: The amounts of residues found in food must be safe 
for consumers and must be as low as possible.'' When new or amended 
tolerances are requested for residues of a pesticide in food or feed, 
the Agency, as is required by section 408 of the FFDCA, estimates the 
risk of the potential exposure to these residues. The Agency has 
concluded after this assessment, that there is a reasonable certainty 
that no harm will result from aggregate human exposure to cyromazine 
and that, accordingly, the cyromazine tolerances on these commodities 
are safe. The commenter has provided no information suggesting that the 
levels approved are not safe.

D. Revisions to Petitioned-For Tolerances

    EPA made two minor wording changes to the existing tolerance 
expression by deleting the phrases ``the insecticide'' and ``. . . , in 
or on the commodity'' at the end of the tolerance expression for 
consistency with Agency policy. For harmonization purposes, the Agency 
is establishing different tolerances for the following commodities than 
what was petitioned for: Leafy green subgroup 4-l6A, Brassica, leafy 
greens, subgroup 4-16B, Celtuce, Fennel, Florence, fresh leaves and 
stalk, Kohlrabi, Leaf petiole vegetable subgroup 22B, Onion, bulb, 
subgroup 3-07A, Pepper/eggplant subgroup 8-10B, and Vegetable, 
brassica, head and stem, group 5-16, except broccoli. Additionally, the 
Agency revised the commodity terminology to use the following correct 
commodity definitions: Leafy greens subgroup 4-16A, Leaf petiole 
vegetable subgroup 22B, Fennel, Florence, fresh

[[Page 53321]]

leaves and stalk, and Pepper/eggplant subgroup 8-10B. Finally, EPA is 
establishing several tolerances that differ from the petitioned-for 
tolerance levels to conform to the Agency's rounding classes.

E. International Trade Considerations

    In this rule, EPA is establishing lower tolerances for cyromazine 
residues in or on onion, potato than the current tolerance. The current 
tolerance for onion, potato is 3.0 ppm, but onion, potato is a 
commodity in the onion, bulb, subgroup 3-07A, for which EPA is 
establishing a new tolerance in this rulemaking at 0.3 ppm. As a 
result, EPA intends for the allowable residues onion, potato to be 
reduced. As discussed in EPA's crop grouping rulemaking, EPA has 
determined that onion, potato is similar to other bulb onions and 
appropriately categorized in subgroup 3-07A. See 72 FR 69150 (Dec. 7, 
2007). Based on residue data supporting the 0.3 ppm tolerance for 
subgroup 3-07A and the similarity of onion, potato to other bulb 
onions, EPA concludes that it is appropriate to reduce the tolerance on 
onion, potato as well.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the 
WTO of the changes to these tolerances in order to satisfy its 
obligations under the Agreement. In addition, the SPS Agreement 
requires that Members provide a ``reasonable interval'' between the 
publication of a regulation subject to the Agreement and its entry into 
force to allow time for producers in exporting Member countries to 
adapt to the new requirement. Accordingly, EPA is establishing an 
expiration date for the existing tolerance to allow this tolerance to 
remain in effect for a period of six months after the effective date of 
this final rule. After the six-month period expires, this tolerance 
will be reduced or revoked, as indicated in the regulatory text, and 
allowable residues on onion, potato must conform to the tolerance for 
subgroup 3-07A.
    This reduction in tolerance level is not discriminatory; the same 
food safety standard contained in the FFDCA applies equally to 
domestically produced and imported foods. The new tolerance level is 
supported by available residue data.

V. Conclusion

    Therefore, tolerances are established for residues of the 
insecticide cyromazine, N-cyclopropyl-1,3,5-triazine-2,4,6-triamine, in 
or on Brassica, leafy greens, subgroup 4-16B at 35 ppm; Celtuce at 10 
ppm; Chickpea, edible podded at 0.4 ppm; Chickpea, succulent shelled at 
0.3 ppm; Dwarf pea, edible podded at 0.4 ppm; Edible podded pea, edible 
podded at 0.4 ppm; English pea, succulent shelled at 0.3 ppm; Fennel, 
Florence, fresh leaves and stalk at 10 ppm; Garden pea, succulent 
shelled at 0.3 ppm; Grass-pea, edible podded at 0.4 ppm; Green pea, 
edible podded at 0.4 ppm; Green pea, succulent shelled at 0.3 ppm; 
Kohlrabi at 35 ppm; Leaf petiole vegetable subgroup 22B at 10 ppm; 
Leafy greens subgroup 4-16A at 10 ppm; Lentil, edible podded at 0.4 
ppm; Lentil, succulent shelled at 0.3 ppm; Onion, bulb, subgroup 3-07A 
at 0.3 ppm; Onion, green, subgroup 3-07B at 3 ppm; Pepper/eggplant 
subgroup 8-10B at 3 ppm; Pigeon pea, edible podded at 0.4 ppm; Pigeon 
pea, succulent shelled at 0.3 ppm; Snap pea, edible podded at 0.4 ppm; 
Snow pea, edible podded at 0.4 ppm; Sugar snap pea, edible podded at 
0.4 ppm; Tomato subgroup 8-10A at 1 ppm; Vegetable, brassica, head and 
stem, group 5-16, except broccoli at 35 ppm; Vegetable, tuberous and 
corm, subgroup 1C at 0.8 ppm.
    In addition, EPA is removing the following tolerances because they 
are superseded by the new tolerances being established in this 
rulemaking: Cabbage, abyssinian at 10.0 ppm; cabbage, seakale at 10.0 
ppm, garlic at 0.2 ppm; garlic, great-headed, bulb at 0.2 ppm; Hanover 
salad, leaves at 10.0 ppm; leek at 3.0 ppm; onion, bulb at 0.2 ppm; 
onion, green at 3.0 ppm; onion, tree at 3.0 ppm; onion, welsh at 3.0 
ppm; pepper at 1.0 ppm; potato at 0.8 ppm; rakkyo, bulb at 0.2 ppm; 
shallot, bulb at 0.2 ppm; shallot, fresh leaves at 3.0 ppm; tomato at 
0.5 ppm; turnip, greens at 10.0 ppm; vegetable, brassica, leafy, group 
5, except broccoli at 10.0; vegetable, leafy, except brassica, group 4 
at 7.0 ppm. Finally, EPA is setting a six-month expiration date for the 
current onion, potato tolerance at 3.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the 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

[[Page 53322]]

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 20, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
 1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.414, revise paragraph (a)(1) introductory text and 
amend the table in paragraph (a)(1) as follows:
0
 a. Add alphabetically the entries ``Brassica, leafy greens, subgroup 
4-16B'';
0
b. Remove the entries for ``Cabbage, abyssinian''; and ``Cabbage, 
seakale'';
0
 c. Add alphabetically the entries ``Celtuce''; ``Chickpea, edible 
podded''; ``Chickpea, succulent shelled''; ``Dwarf pea, edible 
podded''; ``Edible podded pea, edible podded''; ``English pea, 
succulent shelled''; ``Fennel, Florence, fresh leaves and stalk''; 
``Garden pea, succulent shelled'';
0
 d. Remove the entries for ``Garlic''; and ``Garlic, great-headed, 
bulb'';
0
 e. Add alphabetically the entries ``Grass-pea, edible podded''; 
``Green pea, edible podded''; and ``Green pea, succulent shelled'';
0
 f. Remove the entry for ``Hanover salad, leaves'';
0
g. Add alphabetically the entries ``Kohlrabi''; ``Leaf petiole 
vegetable subgroup 22B''; and ``Leafy greens subgroup 4-16A'';
0
h. Remove the entry for ``Leek'';
0
 i. Add alphabetically the entries ``Lentil, edible podded''; and 
``Lentil, succulent shelled'';
0
 j. Remove the entries for ``Onion, bulb''; and ``Onion, green'';
0
 k. Add alphabetically the entries ``Onion, bulb, subgroup 3-07A''; and 
``Onion, green, subgroup 3-07B'';
0
 l. Revise the entry for ``Onion, potato''; to add a footnote 2;
0
m. Remove the entries for ``Onion, tree''; ``Onion, welsh''; and 
``Pepper'';
0
 n. Add alphabetically the entries ``Pepper/eggplant subgroup 8-10B''; 
``Pigeon pea, edible podded''; and ``Pigeon pea, succulent shelled'';
0
 o. Remove the entries for ``Potato''; ``Rakkyo, bulb''; ``Shallot, 
bulb''; and ``Shallot, fresh leaves'';
0
 p. Add alphabetically the entries ``Snap pea, edible podded''; ``Snow 
pea, edible podded''; and ``Sugar snap pea, edible podded'';
0
 q. Remove the entry for ``Tomato'';
0
 r. Add alphabetically the entry ``Tomato subgroup 8-10A'';
0
 s. Remove the entry for ``Turnip, greens'';
0
 t. Add alphabetically the entry ``Vegetable, brassica, head and stem, 
group 5-16, except broccoli'';
0
u. Remove the entries for ``Vegetable, brassica, leafy, group 5, except 
broccoli''; and ``Vegetable, leafy, except brassica, group 4''; and
0
v. Add alphabetically the entry ``Vegetable, tuberous and corm, 
subgroup 1C''.
    The revisions and additions read as follows:


Sec.  180.414  Cyromazine; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
cyromazine, including its metabolites and degradates, in or on the 
commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only cyromazine, N-cyclopropyl-1,3,5-triazine-2,4,6-triamine.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Brassica, leafy greens, subgroup 4-16B......................          35
 
                                * * * * *
Celtuce.....................................................          10
Chickpea, edible podded.....................................         0.4
Chickpea, succulent shelled.................................         0.3
Dwarf pea, edible podded....................................         0.4
Edible podded pea, edible podded............................         0.4
 
                                * * * * *
English pea, succulent shelled..............................         0.3
Fennel, Florence, fresh leaves and stalk....................          10
Garden pea, succulent shelled...............................         0.3
 
                                * * * * *
Grass-pea, edible podded....................................         0.4
Green pea, edible podded....................................         0.4
Green pea, succulent shelled................................         0.3
 
                                * * * * *
Kohlrabi....................................................          35
Leaf petiole vegetable subgroup 22B.........................          10
Leafy greens subgroup 4-16A.................................          10
Lentil, edible podded.......................................         0.4
Lentil, succulent shelled...................................         0.3
 
                                * * * * *
Onion, bulb, subgroup 3-07A.................................         0.3
Onion, green, subgroup 3-07B................................           3
Onion, potato \2\...........................................         3.0
Pepper/eggplant subgroup 8-10B..............................           3
Pigeon pea, edible podded...................................         0.4
Pigeon pea, succulent shelled...............................         0.3
 
                                * * * * *
Snap pea, edible podded.....................................         0.4
Snow pea, edible podded.....................................         0.4
Sugar snap pea, edible podded...............................         0.4
Tomato subgroup 8-10A.......................................           1
Vegetable, brassica, head and stem, group 5-16, except                35
 broccoli...................................................
 
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C...................         0.8
------------------------------------------------------------------------
* * *
\2\ This tolerance expires on April 7, 2020.

* * * * *

[FR Doc. 2019-21542 Filed 10-4-19; 8:45 am]
 BILLING CODE 6560-50-P


