Alpha-cypermethrin; Proposed Pesticide Tolerance, 60940-60943 [2017-27806]
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60940
Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Proposed Rules
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 60
[EPA–HQ–OAR–2017–0638; FRL–9972–45–
OAR]
Denial of Petition To List Concentrated
Animal Feeding Operations Under
Clean Air Act
Environmental Protection
Agency (EPA).
ACTION: Notice of final action denying
petition for rulemaking.
AGENCY:
The U.S. Environmental
Protection Agency (EPA) is providing
notice that it has responded to a petition
for rulemaking titled ‘‘Petition To List
Concentrated Animal Feeding
Operations under Clean Air Act Section
111(b)(1)(A) of the Clean Air Act, and
To Promulgate Standards of
Performance Under Clean Air Act
Sections 111(b)(1)(B) and 111(d).’’ The
Administrator denied the request in a
separate letter to the petitioners. The
letter, which provides a full explanation
of the agency’s rationale for the denial,
is in the docket for this action.
DATES: This action is effective on
December 26, 2017.
FOR FURTHER INFORMATION CONTACT: Mrs.
Allison Costa, Sector Policies and
Programs Division (E143–03), Office of
Air Quality Planning and Standards,
Environmental Protection Agency,
Research Triangle Park, North Carolina
27711; telephone number: (919) 541–
1322; fax number: (919) 541–0516;
email address: costa.allison@epa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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I. How can I get copies of this document
and other related information?
This Federal Register document, the
petition for rulemaking, and the letter
denying the petition for rulemaking are
available in the docket the EPA
established under Docket ID No. EPA–
HQ–OAR–2017–0638. All documents in
the docket are listed on the
www.regulations.gov website. Although
listed in the index, some information is
not publicly available, e.g., confidential
business information or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically through
www.regulations.gov or in hard copy at
the EPA Docket Center (EPA/DC), Room
3334, EPA WJC West Building, 1301
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Constitution Ave. NW, Washington, DC.
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 Air Docket
is (202) 566–1742.
II. Judicial Review
Section 307(b)(1) of the Clean Air Act
indicates which Federal Courts of
Appeals have venue for petitions for
review of final EPA actions. This section
provides, in part, that the petitions for
review must be filed in the United
States Court of Appeals for the District
of Columbia Circuit if: (i) The agency
action consists of ‘‘nationally applicable
regulations promulgated, or final action
taken, by the Administrator,’’ or (ii)
such actions are locally or regionally
applicable, if ‘‘such action is based on
a determination of nationwide scope or
effect and if in taking such action the
Administrator finds and publishes that
such action is based on such a
determination.’’
Any petitions for review of the letter
denying the petition to list concentrated
animal feeding operations as a source
category described in this notice must
be filed in the United States Court of
Appeals for the District of Columbia
Circuit by February 26, 2018.
Dated: December 18, 2017.
E. Scott Pruitt,
Administrator.
[FR Doc. 2017–27622 Filed 12–22–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0234; FRL–9969–97]
Alpha-cypermethrin; Proposed
Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
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.
SUMMARY:
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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: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
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:
DATES:
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
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Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Proposed Rules
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
https://www.epa.gov/dockets/
comments.html.
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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
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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 zetacypermethrin are enriched isomers of
the pyrethroid insecticide cypermethrin.
Although cypermethrin, zetacypermethrin, 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 alphacypermethrin, 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); zetacypermethrin 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.
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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
https://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 alphacypermethrin (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).
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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 alphacypermethrin). 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
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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 alphacypermethrin 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
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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
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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]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.418, paragraph (a)(3):
a. Revise the existing entries for
‘‘Fruit, citrus, group 10–10’’; and ‘‘Hog,
fat’’; and add footnote 1’’; and
■ b. Add alphabetically the following
entries for ‘‘Fruit, citrus, group 10–10’’;
and ‘‘Hog, fat’’.
The additions and revisions read as
follows:
■
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■
§ 180.418 Cypermethrin and isomers
alpha-cypermethrin and zeta-cypermethrin;
tolerances for residues.
(a)(3) * * *
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60943
Comments must be received by
January 25, 2018.
ADDRESSES: Submit your comments,
identified by Docket ID no. EPA–HQ–
*
*
*
*
*
1 .........
Fruit, citrus, group 10–10
10 SFUND–1989–0011, by one of the
Fruit, citrus, group 10–10 ...........
0.35 following methods:
• https://www.regulations.gov. Follow
on-line instructions for submitting
*
*
*
*
*
Hog, fat 1 .....................................
1.0 comments.
Hog, fat .......................................
0.10
• Email: Project Manager:
Hadlock.holly@epa.gov or Community
*
*
*
*
*
Involvement Coordinator: Lane.jackie@
1 This tolerance expires on June 26, 2018.
epa.gov.
• Mail: Holly Hadlock (SFD–7–3),
*
*
*
*
*
U.S. EPA, 75 Hawthorne Street, San
[FR Doc. 2017–27806 Filed 12–22–17; 8:45 am]
Francisco, CA 94105.
BILLING CODE 6560–50–P
• Hand delivery: Holly Hadlock
(SFD–7–3), U.S. EPA, 75 Hawthorne
Street, San Francisco, California. Such
ENVIRONMENTAL PROTECTION
deliveries are accepted only during
AGENCY
EPA’s normal hours of operation, and
special arrangements should be made
40 CFR Part 300
for deliveries of boxed information.
[EPA–HQ–SFUND–1989–0011; FRL–9972–
Instructions: Direct your comments to
58—Region 9]
Docket ID no. EPA–HQ–SFUND–1989–
0011. EPA’s policy is that all comments
National Oil and Hazardous
received will be included in the public
Substances Pollution Contingency
docket without change and may be
Plan; National Priorities List: Partial
made available online at https://
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www.regulations.gov, including any
Lines Superfund Site
personal information provided, unless
the comment includes information
AGENCY: Environmental Protection
claimed to be Confidential Business
Agency.
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ACTION: Notice of proposed rulemaking.
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SUMMARY: The Environmental Protection Do not submit information that you
Agency (EPA) Region 9 is issuing a
consider to be CBI or otherwise
Notice of Intent for Partial Deletion of
protected through https://
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(Site) located in Fillmore, California,
an ‘‘anonymous access’’ system, which
from the National Priorities List (NPL)
means EPA will not know your identity
and requests public comments on this
or contact information unless you
proposed action. The NPL, promulgated provide it in the body of your comment.
pursuant to section 105 of the
If you send an email comment directly
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made available on the internet. If you
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cannot read your comment due to
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Electronic files should avoid the use of
Superfund.
special characters, any form of
This partial deletion pertains to the
encryption, and be free of any defects or
surface soil; a map indicating the area
viruses.
to be deleted is in the public docket.
Docket: All documents in the docket
The groundwater will remain on the
are listed in the https://
NPL and is not being considered for
www.regulations.gov index. Although
deletion as part of this action.
listed in the index, some information is
PO 00000
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]]>Agencies
[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: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://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:
[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. 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 https://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
https://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
