[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Proposed Rules]
[Pages 60940-60943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27806]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0234; FRL-9969-97]


Alpha-cypermethrin; Proposed Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This document proposes to amend existing tolerances for 
residues of alpha-cypermethrin in or on fruit, citrus, group 10-10 and 
hog fat under the Federal Food, Drug, and Cosmetic Act (FFDCA). This 
proposal sets an expiration date for the existing tolerances while 
establishing new lower tolerance levels that will cover the same 
commodities when the current tolerances expire. EPA is proposing these 
changes to correct an error in a previous rulemaking that established 
these tolerances at an unintended level.

DATES: Comments must be received on or before February 26, 2018.

ADDRESSES: Submit your comments, identified by docket identification 
(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 Confidential Business 
Information (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.

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

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. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that

[[Page 60941]]

you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then 
identify electronically within the disk or CD-ROM the specific 
information that is claimed as CBI. In addition to one complete version 
of the comment that includes information claimed as CBI, a copy of the 
comment that does not contain the information claimed as CBI must be 
submitted for inclusion in the public docket. Information so marked 
will not be disclosed except in accordance with procedures set forth in 
40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. This Proposal

    EPA, on its own initiative under FFDCA section 408(e), 21 U.S.C. 
346a(e), is proposing to amend the 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 or on hog, fat from 1.0 ppm to 0.10 ppm. EPA 
is proposing 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 
had reviewed residue field trial data and determined that the 
appropriate tolerance levels for fruit, citrus, group 10-10 and for 
hog, fat were 0.35 ppm and 0.10 ppm, respectively. Unfortunately, the 
instructions to the Federal Register contained incorrect tolerance 
values for these commodities and the incorrect tolerance levels were 
finalized in that rule. To remedy that error, EPA is proposing to 
correct the tolerance levels.

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), 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, consistent with FFDCA 
section 408(b)(2), for tolerances for residues of alpha-cypermethrin.
    Alpha-cypermethrin and zeta-cypermethrin are enriched isomers of 
the pyrethroid insecticide cypermethrin. Although cypermethrin, zeta-
cypermethrin, and alpha-cypermethrin are separate active ingredients 
with different end-use products, they are included together in the 
hazard evaluation for the purpose of human health risk assessment. The 
toxicology database for the cypermethrins includes studies with 
cypermethrin and both of its enriched isomers, and is considered 
complete for the purpose of risk assessment. When considering alpha-
cypermethrin, the EPA also considers potential exposures from the other 
registered cypermethrins (i.e., cypermethrin and zeta-cypermethrin), 
since the three active ingredients are essentially the same active from 
the mammalian toxicity perspective.
    In the final rule published in the Federal Register of February 1, 
2013 (78 FR 7266) (FRL-9376-1), EPA established tolerances for residues 
of alpha-cypermethrin in multiple commodities. Since the publication of 
that final rule, the toxicity profile of alpha-cypermethrin (as 
described in that rule) has not changed, and there have been no 
revisions to the toxicological database for the cypermethrins since 
that rule. In addition, although new tolerances have been established 
since that 2013 rule (tolerances for residues of alpha-cypermethrin in 
or on food commodities/feed commodities (other than those covered by a 
higher tolerance as a result of use on growing crops) in food/feed 
handling establishments at 0.05 ppm December 1, 2014 (79 FR 73210) 
(FRL-9918-88); zeta-cypermethrin in or on alfalfa, forage at 15 ppm and 
alfalfa, hay at 30 ppm December 24, 2014 (79 FR 77391) (FRL-9920-23) 
and corn, field, forage at 9.0 ppm, corn, field, stover at 30 ppm, 
corn, pop, stover at 30 ppm July 30, 2015 (80 FR 45435) (FRL-9929-74), 
these new tolerances have not increased exposure warranting a new risk 
assessment since the rulemaking in February 2013. Because the risk 
assessments supporting the establishment of the February 2013 
tolerances assessed the correct tolerances associated with fruit, 
citrus, group 10-10 (0.35 ppm) and hog fat (0.10 ppm) and found them to 
be adequate, that risk assessment continues to support this proposal. 
Therefore, EPA is relying on those risk assessments in order to support 
the corrected tolerances for alpha-cypermethrin in fruit, citrus, group 
10-10 and hog fat. EPA did ensure that the percent crop treated 
information assessed in the 2010 risk assessment is still valid. The 
most recent Screening Level Usage Analysis (SLUA) dated September 29, 
2016 updating PCT data shows that the 2010 estimates are actually 
overestimates. For a detailed discussion of the aggregate risk 
assessments and determination of safety, refer to the February 1, 2013 
Federal Register final rule and its supporting documents, available at 
http://www.regulations.gov in docket ID number EPA-HQ-OPP-2010-0234.
    Based on the risk assessments and information described in this 
unit, 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 alpha-cypermethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate tolerance-enforcement methods are available in PAM Volume 
II for determining residues of cypermethrin, zeta-cypermethrin and 
alpha-cypermethrin in plant (Method I) and livestock (Method II) 
commodities. Both methods are gas chromatographic methods with 
electron-capture detection (GC/ECD), and have undergone successful 
Agency petition method validations (PMVs). Method I has a limit of 
detection (LOD) of 0.01 ppm, and Method II has LODs of 0.005 ppm in 
milk, and 0.01 ppm in livestock tissues. These methods are not 
stereospecific; thus no distinction is made between residues of 
cypermethrin (all eight stereoisomers), zeta-cypermethrin (enriched in 
four isomers) and alpha-cypermethrin (two isomers).

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).

[[Page 60942]]

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.
    There are multiple Codex MRLs for alpha-cypermethrin, but all are 
in conjunction with MRLs for total cypermethrin isomers (no MRLs have 
been established solely for alpha-cypermethrin). However, although the 
definitions of the isomers covered differ formally between U.S. 
tolerances and Codex MRLs, the definitions of coverage are effectively 
harmonized since the tolerance enforcement methods are not 
stereospecific, and thus do not distinguish between residues of 
cypermethrin, zeta-cypermethrin and alpha-cypermethrin. For enforcement 
purposes, the same moiety is being regulated.
    There is a Codex MRL established for citrus fruits at 0.3 ppm and 
there is no Codex MRL for hog fat. Because the U.S. use patterns differ 
from those upon which the Codex MRLs are based, EPA is not proposing to 
harmonize the U.S. tolerance for citrus fruit.

C. International Trade Considerations

    In this proposal, EPA is proposing to reduce 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 intends to reduce 
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 will notify the WTO of 
its intent to revise this tolerance. 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 in order to allow time for producers in exporting Member 
countries to adapt to the new requirement. At this time, EPA is 
proposing to allow the existing tolerances remain for a period of six 
months after the effective date of the 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.

V. Conclusion

    Therefore, EPA is proposing to amend existing tolerances for 
residues of alpha-cypermethrin in or on fruit, citrus, group 10-10 and 
hog, fat at 0.35 ppm and 0.10 ppm, respectively. EPA is also proposing 
to establish a six-month expiration date for the existing tolerances 
while establishing new lower tolerances for these commodities.

VI. Statutory and Executive Order Reviews

    This proposed action would amend 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 
proposed action has been exempted from review under Executive Order 
12866 due to its lack of significance, this proposed 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 proposed 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 proposed 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). 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 proposed 
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 proposed action directly regulates 
growers, food processors, food handlers, and food retailers, not 
States. This proposed action does not alter the relationships or 
distribution of power and responsibilities established by Congress

[[Page 60943]]

in the preemption provisions of FFDCA section 408(n)(4). For these same 
reasons, the Agency has determined that this proposed 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 proposed 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 proposed action.

List of Subjects in 40 CFR Part 180

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

    Dated: November 13, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be 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.  180.418, paragraph (a)(3):
0
a. Revise the existing entries for ``Fruit, citrus, group 10-10''; and 
``Hog, fat''; and add footnote 1''; and
0
b. Add alphabetically the following entries for ``Fruit, citrus, group 
10-10''; and ``Hog, fat''.
    The additions and revisions 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 June 26, 2018.

* * * * *
[FR Doc. 2017-27806 Filed 12-22-17; 8:45 am]
 BILLING CODE 6560-50-P