82 FR 53423 - Tebufenozide; Pesticide Tolerance Actions

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 220 (November 16, 2017)

EPA is establishing tolerances for residues of tebufenozide in or on multiple commodities, which are identified and discussed later in this document. In addition, EPA is correcting commodity definitions, updating crop group tolerances, and harmonizing U.S. tolerances with Codex. EPA is also removing tolerances for residues of tebufenozide that are no longer needed due to the changes listed. EPA is also amending the existing tolerance for almond, hulls under the Federal Food, Drug, and Cosmetic Act (FFDCA).

[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Rules and Regulations]
[Pages 53423-53426]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24881]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0824; FRL-9966-10]
RIN 2070-ZA16


Tebufenozide; Pesticide Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is establishing tolerances for residues of tebufenozide in 
or on multiple commodities, which are identified and discussed later in 
this document. In addition, EPA is correcting commodity definitions, 
updating crop group tolerances, and harmonizing U.S. tolerances with 
Codex. EPA is also removing tolerances for residues of tebufenozide 
that are no longer needed due to the changes listed. EPA is also 
amending the existing tolerance for almond, hulls under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 16, 2017. However, certain 
regulatory actions will not occur until the date specified in the 
regulatory text. Objections and requests for hearings must be received 
on or before January 16, 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-2008-0824, 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: Christina Scheltema, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 308-2201; 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 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-2008-0824 in the subject line on the first 
page of your submission. All objections and requests for a hearing

[[Page 53424]]

must be in writing, and must be received by the Hearing Clerk on or 
before January 16, 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-2008-0824, 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. Background

A. What actions is the agency taking?

    In the Federal Register of October 14, 2016 (81 FR 71029) (FRL-
9952-75), EPA proposed, pursuant to its authority in section 408(e) of 
the FFDCA, 21 U.S.C. 346a(d)(3), to establish, amend, and remove 
certain tolerances for residues of tebufenozide. The Agency proposed 
that 40 CFR 180.482 be amended by establishing tolerances for residues 
of tebufenozide in or on the following commodities: Bushberry subgroup 
13-07B at 3.0 part per million (ppm); caneberry subgroup 13-07A at 3.0 
ppm; fruit, citrus, group 10-10 at 2.0 ppm; fruit, pome group 11-10 at 
1.0 ppm; nut, tree, group 14-12 at 0.1 ppm; sugarcane, cane at 1.0 ppm; 
sugarcane, molasses at 3.0 ppm; vegetable, fruiting, group 8-10 at 1.0 
ppm. EPA also proposed to increase the existing tolerances for almond, 
hulls from 25 to 30 parts per million (ppm). Finally, EPA proposed to 
remove as unnecessary the following tolerances upon establishment of 
the new tolerances: Apple; berry, group 13; fruit, citrus, group 10; 
fruit, pome; nut, tree, group 14; pistachio; vegetable, fruiting, group 
8; and walnut.
    The proposed rule of October 14, 2016 (FRL-9952-75), provided for a 
60-day comment period and invited public comments. EPA received 
anonymous public comments from three private citizens. The comments and 
EPA's response are presented in Unit IV. E.
    In this final rule, the Agency is establishing, modifying, and 
revoking the tolerances as indicated in its proposal of October 14, 
2016, under its authority in FFDCA section 408(e)(1)(A). EPA is also 
establishing an expiration date for the existing tolerances for fruit, 
pome.

B. What is the Agency's authority for taking this action?

    EPA may issue a regulation establishing, modifying, or revoking a 
tolerance under FFDCA section 408(e).

C. When do these actions become effective?

    As stated in the DATES section, this regulation is effective 
November 16, 2017. In addition, the tolerance for fruit, pome, at 1.5 
ppm, expires on May 16, 2018.

III. Determination of Safety

    There have been no changes in the Agency's assessment of the safety 
of these tolerances since the issuance of the proposal, and no 
additional information or concerns were raised by the commenters 
warranting a reconsideration of the Agency's safety finding in the 
proposal. Therefore, the Agency is incorporating the Aggregate Risk 
Assessment and Determination of Safety as contained in Unit III. of its 
October 14, 2016 proposal and relying upon the findings therein to 
support its conclusion that there is a reasonable certainty that no 
harm will result to the general population, or to infants and children, 
from aggregate exposure to tebufenozide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology is available to enforce the 
tolerance expression, as indicated in the proposal.

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.
    As indicated in the proposed rule, EPA is harmonizing its U.S. 
tolerances for sugarcane; fruit, citrus, group 10-10; fruit, pome, 
group 11-10; and almond, hulls, with Codex MRLs.

C. International Trade Considerations

    In this final rule, EPA is converting the existing crop group 
tolerance on fruit, pome, to fruit, pome, group 11-10, and in the 
process, reducing the crop group tolerance from 1.5 ppm to 1.0 ppm to 
harmonize with Codex MRLs. For the commodities included in crop group 
11-10 that are not covered by the fruit, pome tolerance, the new 
tolerances allow import of those additional commodities with residues 
of tebufenozide up to 1.0 ppm, which is not currently permitted under 
the existing tolerance. However, for the commodities currently in the 
crop group that continue to be included in crop group 11-10, the 
tolerance is reduced from 1.5 ppm to 1.0 ppm. With very few exceptions, 
all of the MRLs for tebufenozide on pome fruits are already at or below 
EPA's proposed tolerance level of 1.0 ppm. As a result, EPA believes 
that a reasonable interval between the publication of this rule and the 
effective date of these tolerances is not necessary; therefore, the 
Agency proposes to make the tolerance of 1.0 ppm for crop group 11-10, 
fruit, pome, effective upon publication of this final rule. 
Nonetheless, because this tolerance change represents a reduction in 
the allowable amount of tebufenozide residues allowed in or on fruit, 
pome, crop group 11, EPA is establishing an expiration date for the 
existing tolerances for fruit, pome, that is six months from the date 
of publication of this final rule. Before that date, residues of 
tebufenozide on those commodities will be permitted up to the 1.5 ppm 
level under the existing fruit, pome, tolerance; after that date, 
residues will need to comply with the new reduced 1 ppm tolerance level 
under crop group 11-10.

[[Page 53425]]

    The Agency is reducing the tolerances on commodities in this crop 
group to harmonize with the Codex MRL. The reduction is appropriate 
based on available data and residues levels resulting from registered 
use patterns. This reduction in tolerance levels is not discriminatory; 
the same food safety standard contained in the FFDCA applies equally to 
domestically produced and imported foods. None of the other tolerance 
actions taken in this rulemaking restrict permissible pesticide 
residues below currently allowed levels in the United States. In 
accordance with the World Trade Organization's (WTO) Sanitary and 
Phytosanitary Measures (SPS) Agreement, EPA intends to promptly publish 
this action with the WTO.

D. Existing Stocks Considerations

    Any commodities listed in the regulatory text of this document that 
are treated with the pesticides subject to this final rule, and that 
are in the channels of trade following the tolerance revocations, shall 
be subject to FFDCA section 408(1)(5), as established by FQPA. Under 
this unit, any residues of this pesticide in or on such food shall not 
render the food adulterated so long as it is shown to the satisfaction 
of the Food and Drug Administration that:
    1. The residue is present as the result of an application or use of 
the pesticide at a time and in a manner that was lawful under FIFRA.
    2. The residue does not exceed the level that was authorized at the 
time of the application or use to be present on the food under a 
tolerance or exemption from tolerance. Evidence to show that food was 
lawfully treated may include records that verify the dates that the 
pesticide was applied to such food.

E. Response to Comments

    The Agency received three comments on its October 14, 2016 
proposal. The comments and EPA's responses follow.
    Comment by private citizen. An anonymous commenter expressed 
concerns about the toxicity of tebufenozide and pesticides in general.
    Agency response. The commenter did not take issue with EPA's 
specific proposal to establish or amend tolerances for tebufenozide or 
with the underlying risk assessments supporting the proposal. The 
commenter did not refer to any specific studies pertaining to the 
toxicity of tebufenozide or the conclusions of the tebufenozide risk 
assessments. Therefore, EPA has not changed its previous determination 
that the tolerances in question are safe and is not making any changes 
in response to these comments.
    Comment by private citizen. An anonymous commenter expressed 
support for implementing the tolerances in the proposed rule. However, 
the commenter also expressed some concern about the potential of 
tebufenozide to cause harm to humans, other mammals, and ecosystems.
    Agency response. The commenter supported EPA's specific proposal to 
establish and amend tolerances with tebufenozide. Although the 
commenter expressed concern regarding the potential effects of 
tebufenozide, he or she did not refer to any specific studies 
pertaining to the conclusions of the risk assessments. Therefore, EPA 
has not changed its previous determination that the tolerances in 
question are safe.
    Comment by private citizen. An anonymous commenter supported the 
crop group reassignments in the proposed rule. This commenter also 
expressed concern that the public might not support the proposed 
increase of the almond hull tolerance from 25 to 30 ppm.
    Agency Response: This commenter did not provide any evidence to 
support his or her concern regarding public support for the proposed 
increase of the almond hull tolerance.
    Therefore, the Agency has not changed its previous determination 
that the 30 ppm almond hull tolerance is safe.

V. Conclusion

    EPA has determined that there is a reasonable certainty that no 
harm will result to the general population, or to infants and children, 
from aggregate exposure to tebufenozide residues. The details of the 
Agency's assessment of the safety of the tebufenozide tolerances may be 
found in the proposed rule; there have been no changes since its 
issuance. Therefore, EPA is incorporating the Aggregate Risk Assessment 
and Determination of Safety as contained in Unit III of its October 14, 
2016 proposal to support the conclusion of a reasonable certainty of no 
harm.
    The Agency hereby establishes tolerances for residues of 
tebufenozide in bushberry subgroup 13-07B at 3.0 ppm; caneberry 
subgroup 13-07A at 3.0 ppm; fruit, citrus, group 10-10 at 2.0 ppm; 
fruit, pome group 11-10 at 1.0 ppm; nut, tree, group 14-12, at 0.1 ppm; 
sugarcane, cane at 1.0 ppm; sugarcane, molasses at 3.0 ppm; and 
vegetable, fruiting, group 8-10 at 1.0 ppm. The Agency is also 
increasing the tolerance for almond, hulls from 25 ppm to 30 ppm. 
Further, upon the establishment of these tolerances, the Agency is 
removing the existing tolerances for apple; berry, group 13; fruit, 
citrus, group 10; nut, tree, group 14; pistachio; vegetable, fruiting, 
group 8; and walnut because they will be superseded by the newly 
established tolerances. Finally, the Agency is establishing a six-month 
expiration date for the current fruit, pome, tolerance.

VI. Statutory and Executive Order Reviews

    In this final rule, EPA is establishing, modifying, and revoking 
tolerances under FFDCA section 408(e). The Office of Management and 
Budget (OMB) has exempted these types of actions (e.g., establishment 
and modification of a tolerance and tolerance revocation for which 
extraordinary circumstances do not exist) from review under Executive 
Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this rule has been exempted from review under 
Executive Order 12866 due to its lack of significance, it 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). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), or 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.). Nor does 
it require any special considerations as required by Executive Order 
12898, entitled ``Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations'' (59 FR 7629, February 
16, 1994); or OMB review or any other Agency action under Executive 
Order 13045, entitled ``Protection of Children from Environmental 
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This 
final rule 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). Pursuant to the Regulatory Flexibility 
Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed 
whether establishment of tolerances, exemptions from tolerances, 
raising of tolerance levels, expansion of exemptions, or revocations 
might significantly impact a substantial number of small entities and 
concluded that, as a general matter, these actions do not impose a 
significant economic impact on a substantial number of small entities. 
These analyses

[[Page 53426]]

for tolerance establishment and modifications, and for tolerance 
revocations were published in the Federal Register of May 4, 1981 (46 
FR 24950) and December 17, 1997 (62 FR 66020) (FRL-5753-1), 
respectively, and were provided to the Chief Counsel for Advocacy of 
the Small Business Administration. In a memorandum dated May 25, 2001, 
EPA determined that eight conditions must all be satisfied for an 
import tolerance or tolerance exemption revocation to adversely affect 
a significant number of small entity importers, and that there is a 
negligible joint probability of all eight conditions holding 
simultaneously with respect to any particular revocation. (This Agency 
document is available in the docket for this rule). Furthermore, for 
tebufenozide, the Agency knows of no extraordinary circumstances that 
exist as to the present rule that would change EPA's previous analysis. 
Taking into account this analysis, and available information concerning 
the pesticides listed in this rule, EPA hereby certifies that this rule 
will not have a significant negative economic impact on a substantial 
number of small entities. The Agency has determined that this rule will 
not have a substantial direct effect on States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999). Executive Order 13132 requires EPA to develop 
an accountable process to ensure ``meaningful and timely input by State 
and local officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This rule directly regulates growers, food processors, 
food handlers, and food retailers, not States. This rule does not alter 
the relationships or distribution of power and responsibilities 
established by Congress in the preemption provisions of FFDCA section 
408(n)(4). For these same reasons, the Agency has determined that this 
rule does not have any ``tribal implications'' as described in 
Executive Order 13175, entitled ``Consultation and Coordination with 
Indian Tribal Governments'' (65 FR 67249, November 9, 2000). Executive 
Order 13175 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by tribal officials in the development of 
regulatory policies that have tribal implications.'' ``Policies that 
have tribal implications'' is defined in the Executive order to include 
regulations that have ``substantial direct effects on one or more 
Indian tribes, on the relationship between the Federal Government and 
the Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.'' This rule will not 
have substantial direct effects on tribal governments, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

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: October 24, 2017.
Richard P. Keigwin, Jr.,
Director, 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.  180.482, the table in paragraph (a)(1) is revised to read 
as follows:


Sec.  180.482  Tebufenozide; tolerances for residues.

    (a) * * * (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................          30
Apple, dry pomace...........................................         3.0
Apple, wet pomace...........................................         3.0
Bushberrry subgroup 13-07B..................................         3.0
Brassica, head and stem, subgroup 5A........................         5.0
Brassica, leafy greens, subgroup 5B.........................        10.0
Canola, refined oil.........................................         4.0
Canola, seed................................................         2.0
Caneberry subgroup 13-07A...................................         3.0
Citrus, oil.................................................        15.0
Cotton......................................................         1.5
Cotton, gin byproducts......................................          30
Cranberry...................................................         1.0
Fruit, citrus, group 10-10..................................         2.0
Fruit, pome \1\.............................................         1.5
Fruit, pome, group 11-10....................................         1.0
Grape.......................................................         3.0
Kiwifruit \2\...............................................         0.5
Leaf petioles subgroup 4B...................................         2.0
Leafy greens subgroup 4A....................................        10.0
Nut, tree, group 14-12......................................         0.1
Peppermint, tops............................................        10.0
Spearmint, tops.............................................        10.0
Sugarcane, cane.............................................         1.0
Sugarcane, molasses.........................................         3.0
Turnip, greens..............................................         9.0
Turnip, roots...............................................         0.3
Vegetable, fruiting, group 8-10.............................         1.0
Vegetable, tuberous and corm, except potato, subgroup 1D....       0.015
------------------------------------------------------------------------
\1\ This tolerance expires on May 16, 2018.
\2\ There are no U.S. registrations on kiwifruit.

* * * * *
[FR Doc. 2017-24881 Filed 11-15-17; 8:45 am]
 BILLING CODE 6560-50-P