83 FR 9442 - Kasugamycin; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 44 (March 6, 2018)

Page Range		9442-9446
FR Document		2018-04529
This regulation establishes tolerances for residues of kasugamycin in or on the cherry subgroup 12-12A and walnut. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Federal Register, Volume 83 Issue 44 (Tuesday, March 6, 2018)
[Federal Register Volume 83, Number 44 (Tuesday, March 6, 2018)]
[Rules and Regulations]
[Pages 9442-9446]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04529]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0519; FRL-9972-96]


Kasugamycin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
kasugamycin in or on the cherry subgroup 12-12A and walnut. 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 March 6, 2018. Objections and 
requests for hearings must be received on or before May 7, 2018, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0519, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
    To access the OCSPP test guidelines referenced in this document

[[Page 9443]]

electronically, please go to http://www.epa.gov/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-2016-0519 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 
May 7, 2018. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0519, 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 June 8, 2017 (82 FR 26641) (FRL-9961-
14), 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 
6E8450) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201W, Princeton, NJ 08540. The petition 
requested that 40 CFR 180.614 be amended by establishing tolerances for 
residues of the fungicide kasugamycin, (3-O-[2-amino-4-[(carboxyimino-
methyl)amino]-2,3,4,6-tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-
chiro-inositol, in or on fruit, stone, subgroup 12-12A at 0.6 parts per 
million (ppm) and walnut at 0.04 ppm. That document referenced a 
summary of the petition prepared by Arysta LifeScience North America, 
LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    In accordance with EPA's significance figures policy, as discussed 
in Unit IV.C., the established tolerance for cherry subgroup 12-12A is 
adjusted slightly from the petition request.

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 kasugamycin including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with kasugamycin 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.
    Kasugamycin is an aminoglycoside antibiotic pesticide with limited 
activity against some plant bacterial and fungal pathogens. There are 
no human or veterinary therapeutic applications due to low efficacy, 
but at one time was used clinically in Japan to treat Pseudomonas 
kidney infections in humans (Shuwirth et al. (2006) Nat. Struct. Mol. 
Biol. 13(10):879-886). The mode of action is distinct from other 
aminoglycosides such as streptomycin, which also has pesticidal uses. 
Kasugamycin inhibits formation of the 30S ribosomal subunit at 
initiation of protein synthesis by perturbing the mRNA-tRNA codon/
anticodon interaction; other aminoglycoside antibiotics bind to the 30S 
ribosomal subunit, but disrupt translation of mRNA at later stages of 
initiation.
    The primary target organs identified for kasugamycin were the 
testes and kidney. These effects were seen at higher dose levels, 
generally at the highest dose tested (HDT). In the rat combined chronic 
toxicity/carcinogenicity study, an increased incidence and severity of 
testicular tubular atrophy was observed at histopathological 
evaluations at 6, 12 and 24 months. Testicular degeneration and atrophy 
were also observed in adult F1 males in the rat reproductive toxicity 
study at the highest dose. Testicular tubular dilatation and 
degeneration were observed in the subchronic mouse study at a dose that 
exceeded the limit dose, but not in the mouse carcinogenicity study, 
which tested at much lower doses. In the dog chronic toxicity study, 
testicular inflammation was reported at the high dose, but was not 
accompanied by atrophic or degenerative changes, and was not considered 
a treatment-related adverse effect.
    Kidney toxicity is often associated with exposure to aminoglycoside 
antibiotics. In the rat reproductive toxicity study, kidney dilatation 
and increased incidence of chronic progressive nephropathy were 
observed in F1 males. In the subchronic rat study, increased incidence 
of eosinophilic bodies (slight severity) in the renal proximal tubular 
cells was reported in males at several dose levels. These effects were 
considered treatment-related but not adverse due to the low severity 
and lack of associated findings.

[[Page 9444]]

However, in female rats, increased epithelial cells in the urinary 
sediment, along with decreased urine pH (also seen in males), was 
considered evidence of possible kidney toxicity. Slight lipofuscin 
deposition in the rat combined chronic toxicity/carcinogenicity study 
was not considered adverse due to the lack of other related findings 
(this study tested up to the NOAEL of the subchronic study). The rat 
metabolism study indicated higher levels of radioactivity in the 
kidneys than other tissues. In the subchronic mouse study, minimal to 
severe basophilia/hyperplasia in the renal pars recta in females was 
observed. No renal effects were seen in the mouse carcinogenicity study 
or in the dog.
    Kasugamycin caused decreased body weight and/or weight gain in 
subchronic studies in the rat, mouse and dog. The chronic studies, 
which tested at lower doses, did not show body weight effects. 
Decreased body weight was also observed in developmental and 
reproductive studies in the rat and the range-finding study for the 
rabbit developmental study. Body weight effects in the mouse 
immunotoxicity study were observed only at a dose exceeding the limit 
dose.
    Kasugamycin appears to be irritating to the oral and 
gastrointestinal tract mucosa. Anal lesions and perianal/perigenital 
staining were observed in the subchronic mouse study. Red and swollen 
skin around the anal opening, and inflammation and ulceration of the 
rectum, were noted in male and female rats of both generations in the 
2-generation reproduction study. In the rat developmental toxicity 
study, distention of the large intestine with stool in the cecum, and 
an increased incidence of loose stool, were reported. Similar findings 
were seen in the rabbit developmental range-finding study among females 
that died or were sacrificed in extremis. These effects may be related 
to the acidity (or other irritant property) of the active ingredient, 
which is primarily excreted unabsorbed and un-metabolized in the feces. 
In the dog, tongue and mouth lesions were reported at the highest dose 
tested in the subchronic toxicity study (but not the chronic study, 
which tested at a lower dose). Systemic effects were not observed in 
the rat 21-day dermal study at doses up to the limit dose, but local 
dermal irritation was observed.
    The available studies, including rat acute and subchronic 
neurobehavioral screening studies, did not show evidence of 
neurotoxicity. A 28-day mouse immunotoxicity study did not show 
evidence of immune system effects.
    There was no evidence of increased quantitative or qualitative 
susceptibility in rat or rabbit developmental toxicity studies, or in 
the rat reproductive study. No developmental effects were seen in the 
rat developmental study up to doses causing maternal toxicity 
(decreased body weight gain, food consumption, and feed efficiency). No 
maternal or developmental toxicity was observed in the main rabbit 
developmental toxicity study, in the dose range-finding study, but 
maternal weight loss, reduced food consumption during dosing and 
abortions (GD 18 or later) were observed at higher doses. Fetal weight 
was decreased at the maternally toxic dose, but could not be evaluated 
at higher doses due to maternal death and abortions. In the rat 
reproductive toxicity study, parental toxicity included decreased body 
weight/weight gain. No offspring toxicity was observed. Reproductive 
toxicity at the highest dose tested (above the parental LOAEL) included 
testicular atrophy, decreased fertility and fecundity in the F1 parents 
for both litters, and an increased pre-coital interval during the F2b 
litter mating period.
    Kasugamycin is classified as ``not likely to be carcinogenic to 
humans,'' based on lack of evidence of carcinogenicity in rat and mouse 
carcinogenicity studies. There was no evidence of genotoxicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by kasugamycin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Kasugamycin. Human Health 
Risk Assessment for the Proposed Section 3 Registration of New Uses of 
the Antibiotic Fungicide on Cherry Subgroup 12-12A and Walnuts'' on 
pages 30-39 in docket ID number EPA-HQ-OPP-2016-0519.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for 
kasugamycin used for human risk assessment is discussed in Unit III.B 
of the final rule published in the Federal Register of August 29, 2014 
(79 FR 51492) (FRL-9911-57).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to kasugamycin, EPA considered exposure under the petitioned-
for tolerances as well as all existing kasugamycin tolerances in 40 CFR 
180.614. EPA assessed dietary exposures from kasugamycin in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
kasugamycin; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United Stated 
Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008). 
As to residue levels in food, EPA assumed tolerance level residues and 
100% crop treated for all registered and proposed crops.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that kasugamycin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.

[[Page 9445]]

    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for kasugamycin. Tolerance-level residues and 100 PCT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for kasugamycin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of kasugamycin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model 5/Variable Volume Water 
Model (VVWM) and Pesticide Root Zone Model Ground Water (PRZM GW), the 
estimated drinking water concentrations (EDWCs) of kasugamycin for 
chronic exposures are estimated to be 1.63 parts per billion (ppb) for 
surface water and 41.71 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration value of 41.71 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).
    Kasugamycin is not registered for any specific use patterns that 
would result in residential exposure.
    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 kasugamycin to share a common mechanism of 
toxicity with any other substances, and kasugamycin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
kasugamycin does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the 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. There was no evidence of 
increased quantitative or qualitative pre- and/or postnatal 
susceptibility in developmental toxicity studies in two species, or the 
rat 2-generation reproductive toxicity study. Abortions and a reduction 
in fetal body weight in the rabbit developmental toxicity range-finding 
study were considered secondary to maternal toxicity (weight loss, and 
decreased food consumption). No toxicity to offspring was observed in 
the rat reproductive toxicity study.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for kasugamycin is complete.
    ii. There is no indication that kasugamycin is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that kasugamycin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to kasugamycin in drinking water. These assessments 
will not underestimate the exposure and risks posed by kasugamycin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
kasugamycin is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
kasugamycin from food and water will utilize 4.2% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for kasugamycin.
    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). Because there 
are no residential uses, kasugamycin is not expected to pose a short-
term risk.
    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. Because there are no residential uses, kasugamycin is not 
expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, kasugamycin 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

[[Page 9446]]

from aggregate exposure to kasugamycin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An approved tolerance enforcement method for crops is available for 
kasugamycin using a reverse-phase, ion pairing HPLC/UV method (Morse 
Laboratories Method #Meth-146, Revision #4) for collecting data and 
enforcing tolerances for kasugamycin in plant commodities. The method 
may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for kasugamycin.

C. Revisions to Petitioned-For Tolerances

    In establishing the tolerance for cherry subgroup 12-12A, EPA added 
a significant figure (0.60 ppm rather than the proposed 0.6 ppm). This 
is in order to avoid the situation where rounding of an observed 
residue to the level of precision of the tolerance expression would be 
considered non-violative (such as 0.64 ppm being rounded to 0.6 ppm).

V. Conclusion

    Therefore, tolerances are established for residues of kasugamycin, 
(3-O-[2-amino-4-[(carboxyimino-methyl)amino]-2,3,4,6-tetradeoxy-
[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol), in or on cherry 
subgroup 12-12A at 0.60 ppm and walnut at 0.04 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); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or 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 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: February 23, 2018.
Michael L. 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.  180.614, add alphabetically the entries ``Cherry subgroup 
12-12A''; and ``Walnut'' to the table in paragraph (a) to read as 
follows:


Sec.  180.614   Kasugamycin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cherry subgroup 12-12A......................................        0.60
 
                                * * * * *
Walnut......................................................        0.04
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-04529 Filed 3-5-18; 8:45 am]
 BILLING CODE 6560-50-P
9442 Federal Register / Vol. 83, No. 44 / Tuesday, March 6, 2018 / Rules and Regulations

Regulations That Significantly Affect V. Congressional Review Act before May 7, 2018, and must be filed
Energy Supply, Distribution, or Use’’ (66 Pursuant to the Congressional Review in accordance with the instructions
FR 28355, May 22, 2001) or Executive Act (5 U.S.C. 801 et seq.), EPA will provided in 40 CFR part 178 (see also
Order 13045, entitled ‘‘Protection of submit a report containing this rule and Unit I.C. of the SUPPLEMENTARY
Children from Environmental Health other required information to the U.S. INFORMATION).
Risks and Safety Risks’’ (62 FR 19885, Senate, the U.S. House of ADDRESSES: The docket for this action,
April 23, 1997); nor is it considered a Representatives, and the Comptroller identified by docket identification (ID)
regulatory action under Executive Order General of the United States prior to number EPA–HQ–OPP–2016–0519, is
13771, entitled ‘‘Reducing Regulations publication of the rule in the Federal available at http://www.regulations.gov
and Controlling Regulatory Costs’’ (82 Register. This action is not a ‘‘major or at the Office of Pesticide Programs
FR 9339, February 3, 2017). This action rule’’ as defined by 5 U.S.C. 804(2). Regulatory Public Docket (OPP Docket)
does not contain any information in the Environmental Protection Agency
collections subject to OMB approval List of Subjects in 40 CFR Part 180 Docket Center (EPA/DC), West William
under the Paperwork Reduction Act Environmental protection, Jefferson Clinton Bldg., Rm. 3334, 1301
(PRA), 44 U.S.C. 3501 et seq., nor does Administrative practice and procedure, Constitution Ave. NW, Washington, DC
it require any special considerations Agricultural commodities, Pesticides 20460–0001. The Public Reading Room
under Executive Order 12898, entitled and pests, Reporting and recordkeeping is open from 8:30 a.m. to 4:30 p.m.,
‘‘Federal Actions to Address requirements. Monday through Friday, excluding legal
Environmental Justice in Minority Dated: February 23, 2018. holidays. The telephone number for the
Populations and Low-Income Richard Keigwin, Jr., Public Reading Room is (202) 566–1744,
Populations’’ (59 FR 7629, February 16, and the telephone number for the OPP
Director, Office of Pesticide Programs.
1994). Docket is (703) 305–5805. Please review
Therefore, 40 CFR chapter I is the visitor instructions and additional
Since tolerances and exemptions that amended as follows:
are established on the basis of a petition information about the docket available
at http://www.epa.gov/dockets.
under FFDCA section 408(d), such as PART 180—[AMENDED]
the tolerance exemption in this action, FOR FURTHER INFORMATION CONTACT:
do not require the issuance of a ■ 1. The authority citation for part 180 Michael L. Goodis, Director,
proposed rule, the requirements of the continues to read as follows: Registration Division (7505P), Office of
Regulatory Flexibility Act (RFA) (5 Pesticide Programs, Environmental
Authority: 21 U.S.C. 321(q), 346a and 371.
U.S.C. 601 et seq.) do not apply. Protection Agency, 1200 Pennsylvania
■ 2. Add § 180.1353 to subpart D to read Ave. NW, Washington, DC 20460–0001;
This action directly regulates growers, as follows: main telephone number: (703) 305–
food processors, food handlers, and food 7090; email address: RDFRNotices@
retailers, not States or tribes. As a result, § 180.1353 Lipochitooligosaccharide
(LCO) SP104; exemption from the
epa.gov.
this action does not alter the
relationships or distribution of power requirement of a tolerance. SUPPLEMENTARY INFORMATION:
and responsibilities established by Residues of the biochemical pesticide I. General Information
Congress in the preemption provisions Lipochitooligosaccharide (LCO) SP104
of FFDCA section 408(n)(4). As such, (which has been used in accordance A. Does this action apply to me?
EPA has determined that this action will with label directions and good You may be potentially affected by
not have a substantial direct effect on agricultural practices) are exempt from this action if you are an agricultural
States or tribal governments, on the the requirement of a tolerance in or on producer, food manufacturer, or
relationship between the national all food commodities. pesticide manufacturer. The following
government and the States or tribal [FR Doc. 2018–04534 Filed 3–5–18; 8:45 am] list of North American Industrial
governments, or on the distribution of BILLING CODE 6560–50–P Classification System (NAICS) codes is
power and responsibilities among the not intended to be exhaustive, but rather
various levels of government or between provides a guide to help readers
the Federal Government and Indian ENVIRONMENTAL PROTECTION determine whether this document
tribes. Thus, EPA has determined that AGENCY applies to them. Potentially affected
Executive Order 13132, entitled entities may include:
‘‘Federalism’’ (64 FR 43255, August 10, 40 CFR Part 180 • Crop production (NAICS code 111).
1999), and Executive Order 13175, [EPA–HQ–OPP–2016–0519; FRL–9972–96] • Animal production (NAICS code
entitled ‘‘Consultation and Coordination 112).
with Indian Tribal Governments’’ (65 FR Kasugamycin; Pesticide Tolerances • Food manufacturing (NAICS code
67249, November 9, 2000), do not apply 311).
to this action. In addition, this action
AGENCY: Environmental Protection • Pesticide manufacturing (NAICS
Agency (EPA). code 32532).
does not impose any enforceable duty or
ACTION: Final rule.
contain any unfunded mandate as B. How can I get electronic access to
described under Title II of the Unfunded SUMMARY: This regulation establishes other related information?
Mandates Reform Act (UMRA) (2 U.S.C. tolerances for residues of kasugamycin You may access a frequently updated
1501 et seq.). in or on the cherry subgroup 12–12A electronic version of EPA’s tolerance
jstallworth on DSKBBY8HB2PROD with RULES

This action does not involve any and walnut. The Interregional Research regulations at 40 CFR part 180 through
technical standards that would require Project Number 4 (IR–4) requested these the Government Printing Office’s e-CFR
EPA’s consideration of voluntary tolerances under the Federal Food, site at http://www.ecfr.gov/cgi-bin/text-
consensus standards pursuant to section Drug, and Cosmetic Act (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
12(d) of the National Technology DATES: This regulation is effective 40tab_02.tpl.
Transfer and Advancement Act March 6, 2018. Objections and requests To access the OCSPP test guidelines
(NTTAA) (15 U.S.C. 272 note). for hearings must be received on or referenced in this document

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9446 Federal Register / Vol. 83, No. 44 / Tuesday, March 6, 2018 / Rules and Regulations

from aggregate exposure to kasugamycin VI. Statutory and Executive Order to this action. In addition, this action
residues. Reviews does not impose any enforceable duty or
IV. Other Considerations This action establishes tolerances contain any unfunded mandate as
under FFDCA section 408(d) in described under Title II of the Unfunded
A. Analytical Enforcement Methodology response to a petition submitted to the Mandates Reform Act (UMRA) (2 U.S.C.
An approved tolerance enforcement Agency. The Office of Management and 1501 et seq.).
method for crops is available for Budget (OMB) has exempted these types This action does not involve any
kasugamycin using a reverse-phase, ion of actions from review under Executive technical standards that would require
pairing HPLC/UV method (Morse Order 12866, entitled ‘‘Regulatory Agency consideration of voluntary
Laboratories Method #Meth-146, Planning and Review’’ (58 FR 51735, consensus standards pursuant to section
Revision #4) for collecting data and October 4, 1993). Because this action 12(d) of the National Technology
enforcing tolerances for kasugamycin in has been exempted from review under Transfer and Advancement Act
plant commodities. The method may be Executive Order 12866, this action is (NTTAA) (15 U.S.C. 272 note).
requested from: Chief, Analytical not subject to Executive Order 13211,
Chemistry Branch, Environmental entitled ‘‘Actions Concerning VII. Congressional Review Act
Science Center, 701 Mapes Rd., Ft. Regulations That Significantly Affect
Meade, MD 20755–5350; telephone Energy Supply, Distribution, or Use’’ (66 Pursuant to the Congressional Review
number: (410) 305–2905; email address: FR 28355, May 22, 2001); Executive Act (5 U.S.C. 801 et seq.), EPA will
residuemethods@epa.gov. Order 13045, entitled ‘‘Protection of submit a report containing this rule and
Children from Environmental Health other required information to the U.S.
B. International Residue Limits Risks and Safety Risks’’ (62 FR 19885, Senate, the U.S. House of
In making its tolerance decisions, EPA April 23, 1997); or Executive Order Representatives, and the Comptroller
seeks to harmonize U.S. tolerances with 13771, entitled ‘‘Reducing Regulations General of the United States prior to
international standards whenever and Controlling Regulatory Costs’’ (82 publication of the rule in the Federal
possible, consistent with U.S. food FR 9339, February 3, 2017). This action Register. This action is not a ‘‘major
safety standards and agricultural does not contain any information rule’’ as defined by 5 U.S.C. 804(2).
practices. EPA considers the collections subject to OMB approval
international maximum residue limits under the Paperwork Reduction Act List of Subjects in 40 CFR Part 180
(MRLs) established by the Codex (PRA) (44 U.S.C. 3501 et seq.), nor does Environmental protection,
Alimentarius Commission (Codex), as it require any special considerations Administrative practice and procedure,
required by FFDCA section 408(b)(4). under Executive Order 12898, entitled Agricultural commodities, Pesticides
The Codex Alimentarius is a joint ‘‘Federal Actions to Address and pests, Reporting and recordkeeping
United Nations Food and Agriculture Environmental Justice in Minority requirements.
Organization/World Health Populations and Low-Income
Organization food standards program, Populations’’ (59 FR 7629, February 16, Dated: February 23, 2018.
and it is recognized as an international 1994). Michael L. Goodis,
food safety standards-setting Since tolerances and exemptions that Director, Registration Division, Office of
organization in trade agreements to are established on the basis of a petition Pesticide Programs.
which the United States is a party. EPA under FFDCA section 408(d), such as
may establish a tolerance that is the tolerances in this final rule, do not Therefore, 40 CFR chapter I is
different from a Codex MRL; however, require the issuance of a proposed rule, amended as follows:
FFDCA section 408(b)(4) requires that the requirements of the Regulatory
EPA explain the reasons for departing Flexibility Act (RFA) (5 U.S.C. 601 et PART 180—[AMENDED]
from the Codex level. seq.), do not apply.
The Codex has not established a MRL This action directly regulates growers, ■ 1. The authority citation for part 180
for kasugamycin. food processors, food handlers, and food continues to read as follows:
retailers, not States or tribes, nor does Authority: 21 U.S.C. 321(q), 346a and 371.
C. Revisions to Petitioned-For this action alter the relationships or
Tolerances distribution of power and ■ 2. In § 180.614, add alphabetically the
In establishing the tolerance for responsibilities established by Congress entries ‘‘Cherry subgroup 12–12A’’; and
cherry subgroup 12–12A, EPA added a in the preemption provisions of FFDCA ‘‘Walnut’’ to the table in paragraph (a)
significant figure (0.60 ppm rather than section 408(n)(4). As such, the Agency to read as follows:
the proposed 0.6 ppm). This is in order has determined that this action will not
to avoid the situation where rounding of have a substantial direct effect on States § 180.614 Kasugamycin; tolerances for
an observed residue to the level of or tribal governments, on the residues.
precision of the tolerance expression relationship between the national (a) * * *
would be considered non-violative government and the States or tribal
(such as 0.64 ppm being rounded to 0.6 governments, or on the distribution of Parts per
ppm). power and responsibilities among the Commodity million
various levels of government or between
V. Conclusion the Federal Government and Indian Cherry subgroup 12–12A ........... 0.60
jstallworth on DSKBBY8HB2PROD with RULES

Therefore, tolerances are established tribes. Thus, the Agency has determined
for residues of kasugamycin, (3-O-[2- that Executive Order 13132, entitled * * * * *
amino-4-[(carboxyimino-methyl)amino]- ‘‘Federalism’’ (64 FR 43255, August 10, Walnut ......................................... 0.04
2,3,4,6-tetradeoxy-a-D-arabino- 1999) and Executive Order 13175,
hexopyranosyl]-D-chiro-inositol), in or entitled ‘‘Consultation and Coordination * * * * *
on cherry subgroup 12–12A at 0.60 ppm with Indian Tribal Governments’’ (65 FR [FR Doc. 2018–04529 Filed 3–5–18; 8:45 am]
and walnut at 0.04 ppm. 67249, November 9, 2000) do not apply BILLING CODE 6560–50–P

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Document Created: 2018-11-01 08:49:34
Document Modified: 2018-11-01 08:49:34
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective March 6, 2018. Objections and requests for hearings must be received on or before May 7, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Contact		Michael L. Goodis, Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
FR Citation		83 FR 9442
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements