[Federal Register Volume 85, Number 196 (Thursday, October 8, 2020)]
[Rules and Regulations]
[Pages 63450-63453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19761]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0338; FRL-10013-94]


Kasugamycin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of kasugamycin in or on almonds. This action is in response to 
EPA's granting of an emergency exemption under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
on almond trees. This regulation establishes maximum permissible levels 
for residues of kasugamycin in or on this commodity. The time-limited 
tolerances expire on December 31, 2023.

DATES: This regulation is effective October 8, 2020. Objections and 
requests for hearings must be received on or before December 7, 2020, 
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-2020-0338, 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting 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 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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-
2020-0338 in the subject line on the first page of your submission. All 
objections and requests for a hearing must be in writing and must be 
received by the Hearing Clerk on or before December 7, 2020. 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

[[Page 63451]]

by docket ID number EPA-HQ-OPP-2020-0338, by one of the following 
methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6), 21 U.S.C. 346a(e) and 346a(1)(6), is establishing 
time-limited tolerances 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 Almond at 0.04 parts per 
million (ppm); and Almond, hulls at 0.4 ppm. These time-limited 
tolerances expire on December 31, 2023.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    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. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Kasugamycin on Almond Trees

    According to the California Department of Pesticide Regulation 
(CDPR), the California almond industry has been experiencing frequent 
frost events with concurrent wetness and temperatures below 0 [deg]C in 
the last several years, specifically from 2013 to 2019. In recent 
seasons (2017, 2018, and 2019), early-spring cold spells have resulted 
in a high incidence of bacterial blast in almond buds and blossoms in 
several almond production areas in California. CDPR claims that these 
freeze events caused direct crop losses in the form of blasted flowers, 
dropped fruit, and shoot dieback affecting future fruiting wood on the 
tree. CDPR claims that frost injury has been described as one of the 
main limiting factors to crop production in many locations in 
California. Some plants' frost injuries have been shown to involve an 
interaction of certain leaf surface bacteria and low temperature 
stress. Some epiphytic bacteria such as P. syringae cause frost-
sensitive plants to become more susceptible to freeze damage by 
initiating the formation of ice that results in frost injury. Many 
pathovars of P. syringae are active in ice nucleation and are the most 
common ice nucleation active bacteria found on plants in the United 
States.
    After having reviewed the submission, EPA determined that an 
emergency condition exists for this State, and that the criteria for 
approval of an emergency exemption were met. EPA has authorized a 
specific exemption under FIFRA section 18 for the use of kasugamycin on 
almond trees for control of bacterial blast in almonds in California.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of kasugamycin 
in or on almonds. In doing so, EPA considered the safety standard in 
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance 
under FFDCA section 408(l)(6) would be consistent with the safety 
standard and with FIFRA section 18. Consistent with the need to move 
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in FFDCA section 408(l)(6). Although 
these time-limited tolerances expire on December 31, 2023, under FFDCA 
section 408(l)(5), residues of the pesticide not in excess of the 
amounts specified in the tolerance remaining in or on almond after that 
date will not be unlawful, provided the pesticide was applied in a 
manner that was lawful under FIFRA, and the residues do not exceed a 
level that was authorized by these time-limited tolerances at the time 
of that application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
kasugamycin meets FIFRA's registration requirements for use on almonds 
or whether permanent tolerances for this use would be appropriate. 
Under these circumstances, EPA does not believe that this time-limited 
tolerance decision serves as a basis for registration of kasugamycin by 
a State for special local needs under FIFRA section 24(c). Nor does 
this tolerance by itself serve as the authority for persons in any 
State other than California to use this pesticide on the applicable 
crops under FIFRA section 18 absent the issuance of an emergency 
exemption applicable within that State. For additional information 
regarding the emergency exemption for kasugamycin, contact the Agency's 
Registration Division at the address provided under FOR FURTHER 
INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    On March 6, 2018, EPA published in the Federal Register a final 
rule establishing tolerances for residues of

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kasugamycin in or on cherry subgroup 12-12A and walnut based on the 
Agency's conclusion that aggregate exposure to kasugamycin is safe for 
the general population, including infants and children. See (83 FR 
9442) (FRL-9972-96). EPA is including the following portions of that 
document by reference here, as they have not changed in the Agency's 
current assessment of kasugamycin tolerances: The toxicological 
profile, assumptions for exposure assessment, and the Agency's 
determination regarding the children's safety factor, which have not 
changed. The Agency is also incorporating the toxicological points of 
departure that are referenced in that document and published in Federal 
Register published on August 29, 2014 (79 FR 51492) (FRL-9911-57), 
which have not changed.
    EPA's exposure assessments have been updated to include the 
additional exposure from use of kasugamycin from use on almonds, 
assuming both tolerance-level residues and 100 percent crop treated.
    An acute dietary endpoint was not identified for kasugamycin, as a 
result, acute dietary risk is not of concern and a separate acute 
dietary exposure analysis was not performed. Chronic dietary risk 
estimates for kasugamycin are below the Agency's level of concern of 
100% of the chronic population adjusted dose (cPAD) for all population 
subgroups. The most highly exposed population subgroup, children 1-2 
years old, had a risk estimate of 4.5% of the cPAD, while the general 
US population had a risk estimate of 1.3% of the cPAD. There are no 
dietary risk estimates of concern associated with the section 18 use of 
kasugamycin on almonds in California, when considered along with 
existing uses of the fungicide.
    Since there are no residential uses of kasugamycin and no 
commercial uses that could result in residential exposure, aggregate 
risk estimates are equivalent to dietary risk estimates, which are not 
of concern.
    Occupational handler exposures to kasugamycin were estimated 
assuming the maximum application rate, and label-recommended equipment 
and methods, and standard assumptions with respect to the area treated. 
In the absence of chemical-specific data to assess handler's exposure 
and risk, EPA relied on surrogate unit exposure data to estimate 
exposure and risk. The Agency assumed a single layer of clothing 
(baseline), without additional personal protective equipment (PPE). The 
resulting handler risk estimates, or margins of exposures, are all 
above 100, and are not of concern.
    Therefore, based on the risk assessments and information described 
above, EPA concludes 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. More detailed information 
on the Agency's analysis to establish a time-limited tolerance in or 
almonds 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'' dated September 27, 2017, in 
docket ID EPA-HQ-OPP-2016-0519 and the document titled, ``Kasugamycin. 
20CA01. Human Health Risk Assessment for the Proposed Section 18 
Specific Exemption for Use on Almonds'' dated April 15, 2020, in docket 
ID number EPA-HQ-OPP-2020-0338.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology (a reverse-phase, ion pairing 
HPLC/UV method (Morse Laboratories Method #Meth-146, Revision #4)) is 
available 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 MRLs for kasugamycin.

VI. Conclusion

    Therefore, time-limited 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 
Almond at 0.04 ppm and Almond, hulls at 0.4 ppm. These tolerances 
expire on December 31, 2023.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(l)(6) in 
response to an emergency exemption application submitted to the Agency. 
The Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled ``Regulatory 
Planning and Review'' (58 FR 51735, October 4, 1993). Because this 
action has been exempted from review under Executive Order 12866, this 
action is not subject to Executive Order 13211, entitled ``Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive Order 
13045, entitled ``Protection of Children from Environmental Health 
Risks and Safety Risks'' (62 FR 19885, April 23, 1997), nor is it 
considered a regulatory action under Executive Order 13771, entitled 
``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, 
February 3, 2017). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(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 in support of 
a FIFRA section 18 emergency exemption do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (5 
U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, but does not directly regulate 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

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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 
(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 (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 25, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, the EPA amends 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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 paragraph (b) to read as follows:


Sec.  180.614  Kasugamycin; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of 
kasugamycin, including metabolites and degradates, in or on the 
specified agricultural commodities, resulting from use of the pesticide 
pursuant to FIFRA section 18 emergency exemptions. Compliance with the 
tolerance levels specified is to be determined by measuring only 
kasugamycin (3-O-[2-amino-4-[(carboxyimino-methyl)amino]-2,3,4,6-
tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol) in or on 
the commodity. The tolerances expire on the date specified in the 
table.

------------------------------------------------------------------------
                                      Parts per
              Commodity                million       Expiration date
------------------------------------------------------------------------
Almond..............................       0.04  December 31, 2023.
Almond, hulls.......................        0.4  December 31, 2023.
------------------------------------------------------------------------

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[FR Doc. 2020-19761 Filed 10-7-20; 8:45 am]
BILLING CODE 6560-50-P