[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Rules and Regulations]
[Pages 25941-25943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12066]



40 CFR Part 180

[EPA-HQ-OPP-2010-0234; FRL-9976-73]

Alpha-cypermethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation amends existing tolerances for residues of 
alpha-cypermethrin in or on fruit, citrus group 10-10 and hog fat. EPA 
is modifying these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA) to correct an error in a previous rulemaking that 
established these tolerances at an unintended level.

DATES: This regulation is effective June 5, 2018. Objections and 
requests for hearings must be received on or before August 6, 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-2010-0234, 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.

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: 


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.

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-2010-0234 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 
August 6, 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-2010-0234, 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 
     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. Proposed Rule

    In the Federal Register of December 26, 2017 (82 FR 60940) (FRL-
9969-97), EPA, pursuant to FFDCA section 408(e), 21 U.S.C. 346a(e), 
proposed revisions to existing tolerances for the insecticide alpha-
cypermethrin to reduce the allowable levels of the pesticide in or on 
fruit, citrus, group 10-10 from 10 parts per million (ppm) to 0.35 ppm 
and in

[[Page 25942]]

or on hog, fat from 1.0 ppm to 0.10 ppm. EPA proposed this action in 
order to correct a typographical error that occurred in the final rule 
establishing these tolerances on February 1, 2013 (78 FR 7266) (FRL-
9376-1). In support of the 2013 final rule, EPA reviewed residue field 
trial data and determined that the appropriate tolerance levels for 
fruit, citrus, group 10-10 and hog, fat were 0.35ppm and 0.10 ppm, 
respectively. Unfortunately, the instruction to the Federal Register 
contained incorrect tolerance values for these commodities, resulting 
in incorrect tolerance levels being finalized in that rule. The 
proposal would correct that error.
    In the proposal, EPA discussed the Agency's assessment of risk and 
proposed determination of safety for aggregate exposures to alpha-
cypermethrin. In summary, the Agency concluded that the proposed 
tolerances for fruit, citrus, group 10-10 and hog, fat would be safe.
    Two comments were received on the proposal. One simply read 
``Good'' and the other was related to the impact of wind-power 
facilities on bat populations and is therefore not relevant to this 

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 alpha-cypermethrin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with alpha-
cypermethrin can be found in the proposed rule published December 26, 
2017, and EPA is incorporating its findings in that preamble into this 
final rule. For the reasons stated in the proposal, EPA concludes that 
there is a reasonable certainty that no harm will result to the general 
population, including infants and children, from aggregate exposure to 

IV. International Trade Considerations

A. International Residue Limits

    As noted in the proposal, 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 
    There is a Codex MRL established for citrus fruits at 0.3 ppm but 
not one for hog fat. Because the U.S. use patterns differ from those 
upon which the Codex MRLs are based, EPA is not harmonizing the U.S. 
tolerance for citrus fruit.

B. World Trade Organization Sanitary and Phytosanitary Measures 

    In this Final Rule, EPA is reducing the existing tolerances for 
commodities in crop group 10-10 from 10 ppm to 0.35 ppm and on hog, fat 
from 1.0 ppm to 0.1 ppm. The Agency is reducing these tolerances to 
correct the tolerance levels that EPA intended to establish in a 
previous rulemaking based on available residue data.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA notified the WTO of its 
proposed tolerance revision on January 10, 2018. See http://spsims.wto.org/en/Notifications/Search, U.S. Notification (G/SPS/N/USA/
2976). EPA also intends to submit another notification to the WTO in 
order to satisfy its obligation to promptly publish this rule in such a 
manner as to enable interested WTO members to become acquainted with 
this rule. In addition, the SPS Agreement requires that Members provide 
a ``reasonable interval'' between the publication of a regulation 
subject to the Agreement and its entry into force to allow time for 
producers in exporting Member countries to adapt to the new 
requirement. At this time, EPA is establishing an expiration date for 
the existing tolerances to allow those tolerances to remain in effect 
for a period of six months after the effective date of this final rule, 
in order to address this requirement.
    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. The new tolerance levels are 
supported by available residue data.

V. Conclusion

    Therefore, tolerances are established for residues of alpha-
cypermethrin, alpha-cypermethrin, in or on fruit, citrus group 10-10 
and hog fat at 0.35 and 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This action amends existing tolerances under FFDCA section 408(e) 
in an action taken on the Agency's own initiative. 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 due to its lack of 
significance, 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), nor 
is it subject to 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.), 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 
under 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 
Agency action under Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). 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

[[Page 25943]]

(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 for tolerance establishments 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 in order 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. Furthermore, 
for alpha-cypermethrin, 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. In addition, the 
Agency has determined that this action 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 action directly regulates growers, food processors, 
food handlers, and food retailers, not States. This action 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 
action 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 action 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 action.

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: April 30, 2018.
Richard P. Keigwin, Jr.,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.418, in the table in paragraph (a)(3):
i. Amend the existing entries for ``Fruit, citrus, group 10-10''; and 
``Hog, fat'' by adding footnote references and add footnote 1 to the 
end of the table; and
ii. Add alphabetically new entries for ``Fruit, citrus, group 10-10''; 
and ``Hog, fat''.
    The additions to the table in paragraph (a)(3) read as follows:

Sec.  180.418  Cypermethrin and isomers alpha-cypermethrin and zeta-
cypermethrin; tolerances for residues.

    (a)(3) * * *

                                                               Parts per
                          Commodity                             million
                                * * * * *
Fruit, citrus, group 10-10 \1\..............................          10
Fruit, citrus, group 10-10..................................        0.35
                                * * * * *
Hog, fat \1\................................................         1.0
Hog, fat....................................................        0.10
                                * * * * *
\1\ This tolerance expires on December 5, 2018.

* * * * *
[FR Doc. 2018-12066 Filed 6-4-18; 8:45 am]