[Federal Register Volume 83, Number 44 (Tuesday, March 6, 2018)]
[Rules and Regulations]
[Pages 9442-9446]
[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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; 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

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.

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.

    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

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:<PHONE_NUMBER>; 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


[Federal Register Volume 87, Number 225 (Wednesday, November 23, 2022)]
[Notices]
[Pages 71652-71654]
[FR Doc No: 2022-25516]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2796]

Bristol Myers Products Inc.; Proposal To Withdraw Approval of a
New Drug Application for Bufferin (Aspirin) Tablets; Opportunity for a
Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is proposing to withdraw approval
of a new drug application (NDA) for Bufferin (aspirin) tablets, for
which Bristol Myers Products Inc., 1350 Liberty Ave., Hillside, NJ
07205 is the last holder of record, and is announcing an opportunity
for the holder of the NDA to request a hearing on this proposal. The
basis for the proposal is that the holder of the NDA has repeatedly
failed to file required annual reports for this NDA.

DATES: The holder of the NDA may submit a request for a hearing by
December 23, 2022. Submit all data, information, and analyses upon
which the request for a hearing relies by January 23, 2023. Submit
electronic or written comments by January 23, 2023.

ADDRESSES: The request for a hearing may be submitted by the holder of
the NDA by either of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments to submit your request
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a
hearing, will be posted to the docket unchanged.

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     Because your request for a hearing will be made public,
you are solely responsible for ensuring that your request does not
include any confidential information that you or a third party may not
wish to be posted, such as medical information, your or anyone else's
Social Security number, or confidential business information, such as a
manufacturing process. The request for a hearing must include the
Docket No. FDA-2022-N-2796 for ``Bristol Myers Products Inc.; Proposal
To Withdraw Approval of a New Drug Application for Bufferin (Aspirin)
Tablets; Opportunity for a Hearing.'' The request for a hearing will be
placed in the docket and publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday. The holder of the NDA may submit all
data and analyses upon which the request for a hearing relies in the
same manner as the request for a hearing except as follows:
     Confidential Submissions--To submit any data analyses with
confidential information that you do not wish to be made publicly
available, submit your data and analyses only as a written/paper
submission. You should submit two copies total of all data and
analyses. One copy will include the information you claim to be
confidential with a heading or cover note that states ``THIS DOCUMENT
CONTAINS

CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including
the claimed confidential information, in its consideration of any
decisions on this matter. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov or available
at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday
through Friday. Submit both copies to the Dockets Management Staff. Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law.
    Comments Submitted by Other Interested Parties: For all comments
submitted by other interested parties, submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-2796 for ``Bristol Myers Products Inc.; Proposal To Withdraw
Approval of a New Drug Application for Bufferin (Aspirin) Tablets;
Opportunity for a Hearing.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jennifer Forde, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
348-3035.

SUPPLEMENTARY INFORMATION: On June 30, 1948, NDA 006499 for Bufferin
(aspirin) tablets became effective. The holder of NDA 006499 is
currently identified in FDA's records as Bristol Myers Products Inc.
The Agency has received conflicting information regarding the identity
of the current NDA holder. However, to change the holder of record,
information specified in Sec.  314.72 (21 CFR 314.72) must be provided
to the Agency. Since the time that the holder of record was identified
as Bristol Myers Products Inc., the Agency has not received change of
application ownership information that would satisfy the requirements
of Sec.  314.72. The Agency therefore is identifying Bristol Myers
Products Inc. as the NDA holder of record in this Federal Register
notice, but in the event that another entity holds NDA 006499, the
Agency is also providing notice to that entity.
    The holder of an approved NDA to market a new drug for human use is
required to submit annual reports to FDA concerning its approved NDA
under Sec.  314.81 (21 CFR 314.81). The holder of NDA 006499 for
Bufferin (aspirin) tablets has repeatedly failed to submit the required
annual reports.
    Therefore, notice is given to the holder of NDA 006499 and to all
other interested persons that the Director of CDER proposes to issue an
order, under section 505(e) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(e)), withdrawing approval of NDA 006499 and
all amendments and supplements thereto on the grounds that the holder
of the NDA has failed to submit reports required under Sec.  314.81.
    In accordance with section 505 of the FD&C Act and part 314 (21 CFR
part 314), the holder of NDA 006499 is hereby provided an opportunity
for a hearing to show why the approval of NDA 006499 should not be
withdrawn and an opportunity to raise, for administrative
determination, all issues relating to the legal status of the drug
product covered by NDA 006499.
    Withdrawal of the approval of NDA 006499 will not impact
nonprescription aspirin products that are legally marketed without an
approved application as over the counter (OTC) monograph drugs in
accordance with section 505G of the FD&C Act (21 U.S.C 355h), including
conforming to applicable conditions of use specified in OTC Monograph
M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products
for Over-the-Counter Human Use (See OTC

[email protected] web page available at https://www.accessdata.fda.gov/scripts/cder/omuf/?event=reqOrders). Based on information available to
the Agency, it appears that the product covered by NDA 006499 has not
been marketed for many years and another buffered aspirin drug product,
using the same trade name ``Bufferin'' but with a different
formulation, is currently being marketed as an OTC monograph drug. The
marketing of this current ``Bufferin'' product is subject to the
requirements for legal marketing of OTC monograph drugs under section
505G of the FD&C Act and will be unaffected by withdrawal of approval
of NDA 006499.
    To seek a hearing, the NDA holder must file the following: (1) a
written notice of participation and request for a hearing (see DATES
and ADDRESSES) and (2) the data, information, and analyses relied on to
demonstrate that there is a genuine and substantial issue of fact that
requires a hearing (see DATES and ADDRESSES). Any other interested
person may also submit comments on this notice. The procedures and
requirements governing this notice of opportunity for a hearing, notice
of participation and request for a hearing, the information and
analyses to justify a hearing, other comments, and a grant or denial of
a hearing are contained in Sec.  314.200 and in 21 CFR part 12.
    The failure of the NDA holder to file a timely written notice of
participation and request for a hearing, as required by Sec.  314.200,
constitutes an election by the NDA holder not to avail itself of the
opportunity for a hearing concerning CDER's proposal to withdraw
approval of the application and constitutes a waiver of any contentions
concerning the legal status of the drug product. FDA will then withdraw
approval of the application, and the drug product may not thereafter be
lawfully introduced or delivered for introduction into interstate
commerce. Any new drug product introduced or delivered for introduction
into interstate commerce without an approved application is subject to
regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or
denials but must present specific facts showing that there is a genuine
and substantial issue of fact that requires a hearing. If a request for
a hearing is not complete or is not supported, the Commissioner of Food
and Drugs will enter summary judgment against the person who requests
the hearing, making findings and conclusions, and denying a hearing.
    Paper submissions under this notice of opportunity for a hearing
must be filed in two copies. Except for data and information prohibited
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the
submissions may be seen at the Dockets Management Staff (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at https://www.regulations.gov.
    This notice is issued under section 505(e) of the FD&C Act and
under authority delegated to the Director of CDER by the Commissioner
of Food and Drugs.

    Dated: November 17, 2022.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 2022-25516 Filed 11-22-22; 8:45 am]
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[Federal Register Volume 88, Number 96 (Thursday, May 18, 2023)]
[Notices]
[Pages 31843-31845]
[FR Doc No: 2023-10634]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0154; FMCSA-2013-0124; FMCSA-2014-0102; FMCSA-
2014-0103; FMCSA-2014-0104; FMCSA-2014-0106; FMCSA-2014-0107; FMCSA-
2015-0328; FMCSA-2016-0003; FMCSA-2018-0135; FMCSA-2018-0136; FMCSA-
2018-0137; FMCSA-2020-0027; FMCSA-2020-0028]

Qualification of Drivers; Exemption Applications; Hearing

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to renew exemptions for 28
individuals from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these hard of hearing and deaf
individuals to continue to operate CMVs in interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates provided
below.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room
W64-224, Washington, DC 20590-0001,<PHONE_NUMBER>,
[email protected]. Office hours are 8:30 a.m. to 5 p.m. ET Monday
through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number (FMCSA-2012-0154, FMCSA-2013-0124, FMCSA-2014-0102, FMCSA-2014-
0103, FMCSA-2014-0104, FMCSA-2014-0106, FMCSA-2014-0107, FMCSA-2015-
0328, FMCSA-2016-0003, FMCSA-2018-0135, FMCSA-2018-0136, FMCSA-2018-
0137, FMCSA-2020-0027, or FMCSA-2020-0028) in the keyword box and click
``Search.'' Next, sort the results by ``Posted (Newer-Older),'' choose
the first notice listed, and click ``Browse Comments.'' If you do not
have access to the internet, you may view the docket online by visiting
Dockets Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m. ET Monday through Friday, except Federal holidays. To
be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption requests. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov. As described in the system of records
notice DOT/ALL 14 (Federal Docket Management System), which can be
reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices, the comments are searchable by the name of
the submitter.

II. Background

    On March 1, 2023, FMCSA published a notice announcing its decision
to renew exemptions for 28 individuals from the hearing standard in 49
CFR 391.41(b)(11) to operate a CMV in interstate commerce and requested
comments from the public (88 FR 13007). The public comment period ended
on March 31, 2023, and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would likely achieve a level
of safety that is equivalent to, or greater than, the level that would
be achieved by complying with Sec.  391.41(b)(11).
    The physical qualification standard for drivers regarding hearing
found in Sec.  391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5--1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing aid
(35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 8, 1971),
respectively).

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based upon its evaluation of the 28 renewal exemption applications,
FMCSA announces its decision to exempt the following drivers from the
hearing requirement in Sec.  391.41 (b)(11).
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of March and
are discussed below:
    As of March 3, 2023, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following 14 individuals have satisfied the renewal
conditions for obtaining an exemption from the hearing requirement in
the FMCSRs for interstate CMV drivers (88 FR 13007):

Kevin Beacham (MD)
Mark Cole (MD)
Joseph Conversa (IL)
Chauncey Crawford (OH)
Tyjuan Davis (VA)
John Dumars (FL)
Scott Friede (TX)
Calvin Gousby (NV)
Joshua Johnson (CO)
Kimothy McLoed (GA)
Dustin R. Miller, (MI)
Taryn Peterson (IA)
Nolen Soler (NE)
Brandon Veronie (LA)

    The drivers were included in docket numbers FMCSA-2012-0154, FMCSA-
2014-0103, FMCSA-2014-0106, FMCSA-2015-0328, FMCSA-2016-0003, FMCSA-
2018-0135, FMCSA-2018-0136, FMCSA-2020-0027, or FMCSA-2020-0028. Their
exemptions were applicable as of March 3, 2023 and will expire on March
3, 2025.
    As of March 10, 2023, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following two individuals have satisfied the renewal
conditions for obtaining an exemption from the hearing requirement in
the FMCSRs for interstate CMV drivers (88 FR 13007):

Susan D. Helgerson (WI) and David A. Helgerson (WI).

    The drivers were included in docket number FMCSA-2013-0124. Their
exemptions were applicable as of March 10, 2023 and will expire on
March 10, 2025.
    As of March 13, 2023, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following two individuals have satisfied the renewal
conditions for obtaining an exemption from the hearing requirement in
the FMCSRs for interstate CMV drivers (88 FR 13007):

John L. Huey (GA) and Scott M. Putnam (FL)

    The drivers were included in docket number FMCSA-2014-0107. Their
exemptions were applicable as of March 13, 2023 and will expire on
March 13, 2025.
    As of March 19, 2023, and in accordance with 49 U.S.C. 31136(e) and
31315(b), Victor H. Morales (TX) has satisfied the renewal conditions
for obtaining an exemption from the hearing requirement in the FMCSRs
for interstate CMV drivers (88 FR 13008).
    This driver was included in docket number FMCSA-2014-0106. The
exemption was applicable as of March 19, 2023 and will expire on March
19, 2025.
    As of March 22, 2023, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following three individuals have satisfied the renewal
conditions for obtaining an exemption

from the hearing requirement in the FMCSRs for interstate CMV drivers
(88 FR 13007):

William B. Britt (TN); Lawrence Hung K. Lam (CA); and Phillip P. Shook
(MS)

    The drivers were included in docket number FMCSA-2018-0137. Their
exemptions were applicable as of March 22, 2023 and will expire on
March 22, 2025.
    As of March 29, 2023, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following six individuals have satisfied the renewal
conditions for obtaining an exemption from the hearing requirement in
the FMCSRs for interstate CMV drivers (88 FR 13008):

Jeremy Brandyberry (NE)
Kenneth Harris (TX)
Joseph Kelly (PA)
Timothy Laporte (SC)
Brandon Londo (TX)
Jesse Shelander (TX)

    The drivers were included in docket numbers FMCSA-2013-0124, FMCSA-
2014-0102, FMCSA-2014-0103, FMCSA-2014-0104, or FCMSA-2014-0106. Their
exemptions were applicable as of March 29, 2023 and will expire on
March 29, 2025.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) the person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136, 49
U.S.C. chapter 313, or the FMCSRs.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-10634 Filed 5-17-23; 8:45 am]
BILLING CODE 4910-EX-P