Alpha-cypermethrin; Pesticide Tolerances, 73210-73213 [2014-28934]
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Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations
described in the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104–4).
Executive Order 13132: Federalism
This action also does not have
Federalism implications because it does
not 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, as specified in
Executive Order 13132 (64 FR 43255,
August 10, 1999). This action merely
disapproves a state rule, and does not
alter the relationship or the distribution
of power and responsibilities
established in the CAA.
Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This rule is not approved to apply on
any Indian reservation land or in any
other area where EPA or an Indian tribe
has demonstrated that a tribe has
jurisdiction. In those areas of Indian
country, the rule does not have tribal
implications as specified by Executive
Order 13175 (65 FR 67249, November 9,
2000), nor will it impose substantial
direct costs on tribal governments or
preempt tribal law.
Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
This rule also is not subject to
Executive Order 13045 ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), because it disapproves
a state rule.
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Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
Because it is not a ‘‘significant
regulatory action’’ under Executive
Order 12866 or a ‘‘significant energy
action,’’ this action is also not subject to
Executive Order 13211, ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001).
National Technology Transfer
Advancement Act
In reviewing state submissions, EPA’s
role is to approve state choices,
provided that they meet the criteria of
the CAA. In this context, in the absence
of a prior existing requirement for the
state to use voluntary consensus
standards (VCS), EPA has no authority
to disapprove a state submission for
failure to use VCS. It would thus be
inconsistent with applicable law for
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EPA, when it reviews a state
submission, to use VCS in place of a
state submission that otherwise satisfies
the provisions of the CAA. Thus, the
requirements of section 12(d) of the
National Technology Transfer and
Advancement Act of 1995 (15 U.S.C.
272 note) do not apply.
Executive Order 12898: Federal Actions
to Address Environmental Justice in
Minority Populations and Low-Income
Populations
Executive Order 12898 (59 FR 7629
(Feb. 16, 1994)) establishes Federal
executive policy on environmental
justice. Its main provision directs
Federal agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations and low-income
populations in the United States.
EPA lacks the discretionary authority
to address environmental justice in this
action. In reviewing SIP submissions,
EPA’s role is to approve or disapprove
state choices, based on the criteria of the
CAA. Accordingly, this action merely
disapproves certain state requirements
for inclusion into the SIP under section
110 and subchapter I, part D of the CAA
and will not in-and-of itself create any
new requirements. Accordingly, it does
not provide EPA with the discretionary
authority to address, as appropriate,
disproportionate human health or
environmental effects, using practicable
and legally permissible methods, under
Executive Order 12898.
Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. 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. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
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Court of Appeals for the appropriate
circuit by February 9, 2015. Filing a
petition for reconsideration by the
Administrator of this final rule does not
affect the finality of this rule for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action may not
be challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Nitrogen oxides, Ozone, Volatile organic
compounds.
Dated: November 25, 2014.
Susan Hedman,
Regional Administrator, Region 5.
40 CFR part 52 is amended as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
2. Section 52.777 is amended by
adding paragraph (ss), to read as
follows:
■
§ 52.777 Control strategy: photochemical
oxidents (hydrocarbons).
*
*
*
*
*
(ss) Disapproval. EPA is disapproving
Indiana’s December 5, 2012, ozone
redesignation request for Lake and
Porter Counties for the 2008 ozone
standard. EPA is also disapproving
Indiana’s motor vehicle emission
budgets and ozone maintenance plan
submitted with the redesignation
request.
[FR Doc. 2014–28799 Filed 12–9–14; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0601; FRL–9918–88]
Alpha-cypermethrin; Pesticide
Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of alphacypermethrin in or on food
SUMMARY:
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commodities/feed commodities in food/
feed handling establishments. BASF on
behalf of Whitmire Micro-Gen Research
Laboratories requested this tolerance
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
This regulation is effective
December 10, 2014. Objections and
requests for hearings must be received
on or before February 9, 2015, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0601, is
available at https://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 https://www.epa.gov/dockets.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, 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
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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).
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B. How can I get electronic access to
other related information?
II. Summary of Petitioned-For
Tolerance
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 https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
In the Federal Register of September
5, 2014 (79 FR 53009) (FRL–9914–98),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 3F8189) by BASF
on behalf of Whitmire Micro-Gen
Research Laboratories, 3568 Tree Court
Industrial Blvd., St. Louis, MO 63122–
6682. The petition requested that 40
CFR part 180 be amended by
establishing tolerances for residues of
the insecticide alpha-cypermethrin, in
or on food/feed handling establishments
at 0.05 parts per million (ppm). That
document referenced a summary of the
petition prepared by BASF on behalf of
Whitmire Micro-Gen Research
Laboratories, the registrant, which is
available in the docket, https://
www.regulations.gov. Comments were
received on the notice of filing. EPA’s
response to these comments is
discussed in Unit IV.C.
EPA has corrected the proposed
commodity definition to read 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.
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–2014–0601 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 February 9, 2015. 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–
2014–0601, 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 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.
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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
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aggregate exposure for alphacypermethrin including exposure
resulting from the tolerances established
by this action. EPA’s assessment of
exposures and risks associated with
alpha-cypermethrin follows.
Alpha-cypermethrin is an enriched
isomer of the pyrethroid insecticide
cypermethrin. In addition, zetacypermethrin is also an enriched isomer
of cypermethrin. 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 3 active ingredients are
essentially the same active from the
mammalian toxicity perspective. The
recommended tolerance of 0.05 ppm
associated with the food handling
establishment use of alphacypermethrin is at the same level as the
one currently established for zetacypermethrin. Based on the available
alpha-cypermethrin residue data
submitted for the food handling
establishment use, this use will not
result in alpha-cypermethrin residues
higher than 0.05 ppm and is the same
as the existing tolerance of 0.05 ppm
established to support the food handling
establishment uses for zetacypermethrin. The existing dietary and
aggregate risk assessments already
account for the impact of the existing
zeta-cypermethrin food handling
establishment use (i.e. 100% crop
treated for all commodities without an
existing tolerance). Therefore, the
addition of the food handling
establishment use for alphacypermethrin will have no impact on
the dietary risk estimates, as they are
already covered in the existing dietary
and aggregate risk assessments.
In the Federal Register of February 1,
2013 (78 FR 7266) (FRL–9376–1), the
EPA published a final rule to establish
tolerances for residues of the insecticide
alpha-cypermethrin in or on alfalfa, hay
at 15 ppm; citrus, dried pulp at 1.8 ppm;
citrus fruit, Group 10 at 0.35 ppm;
citrus, oil at 4.0 ppm; corn, grain;
cottonseed; cucurbit vegetables, Group
9; dried shelled pea and bean, except
soybean, subgroup 6C; edible podded
legume vegetable, subgroup 6A; fruiting
vegetables, Group 8; head and stem
Brassica, subgroup 5A at 2.0 ppm; leafy
vegetable, except Brassica, Group 4 at 10
ppm; pop-corn; rice, grain at 1.5 ppm;
root and tuber vegetables, Group 1 at 0.1
ppm; sorghum, grain at 0.5 ppm;
soybeans; succulent shelled pea and
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bean, subgroup 6B; sugar beet, roots at
0.05 ppm; sugar beet, tops; sweet corn;
tree nuts, Group 14; and wheat, grain at
0.2 ppm. Since the publication of the
February 1, 2013 final rule, the toxicity
profile of alpha-cypermethrin has not
changed and since the food handling
establishment use for alphacypermethrin will have no impact on
the dietary or aggregate risk estimates,
the risk assessments that supported the
establishment of those alphacypermethrin tolerances published in
the February 1, 2013 Federal Register
remain valid. Therefore, EPA is relying
on those risk assessments in order to
support the new food handling
tolerance for alpha-cypermethrin.
For a detailed discussion of the
aggregate risk assessments and
determination of safety for the food
handling tolerance, please refer to the
February 1, 2013 Federal Register
document and its supporting
documents, available at https://
www.regulations.gov in Docket ID
number EPA–HQ–OPP–2010–0234. EPA
relies upon those supporting risk
assessments and the findings made in
the Federal Register document in
support of this final rule.
Based on the risk assessments and
information described above, 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. Further
information can also be found in the
document, ‘‘Alpha-Cypermethrin—
Human Health Risk Assessment for Two
New Proposed Products for Use in
Commercial/Residential Settings’’ in
docket ID number EPA–HQ–OPP–2014–
0601.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate tolerance-enforcement
methods are available in Pesticide
Analytical Manual (PAM) Volume II for
determining residues of cypermethrin,
zeta-cypermethrin and alphacypermethrin 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
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(enriched in four isomers) and alphacypermethrin (two isomers).
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
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.
There is no Codex MRL for residues
of alpha-cypermethrin in or on food
commodities/feed commodities (other
than those covered by a higher tolerance
as a results of use on growing crops) in
food/feed handling establishments.
C. Response to Comments
The EPA received 4 comments in
response to this Notice of Filing. Two
commenters were opposed to increasing
the amount of pesticides being used and
did not approve of the proposal. The
Agency understands the commenter’s
concerns and recognizes that some
individuals believe that certain
pesticide chemicals should not be
permitted in our food. However, the
existing legal framework provided by
section 408 of the FFDCA states that
tolerances may be set when EPA
determines that aggregate exposure to
that pesticide is safe, i.e., that there is
a reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue. When
making this determination, EPA
considers the toxicity, including any
potential carcinogenicity, of the
pesticide and all anticipated dietary
exposures and all other exposures for
which there is reliable information. EPA
also gives special consideration to the
potential susceptibility and exposures of
infants and children to the pesticide
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chemical residue when making this
determination. For alpha-cypermethrin,
the Agency has considered all the
available data, including all available
data concerning the potential for
carcinogenicity and concluded after
conducting a risk assessment, that there
is a reasonable certainty that no harm
will result from aggregate human
exposure to alpha-cypermethrin.
Two additional commenters raised
concerns regarding exposure to bees.
However, the proposed use is for
pesticide applications to be made
indoors to food/feed handling
establishments and therefore, there
should be no exposure to bees from the
proposed application.
V. Conclusion
Therefore, the tolerance is established
for residues of alpha-cypermethrin, in or
on food commodities/feed commodities
(other than those covered by a higher
tolerance as a results of use on growing
crops) in food/feed handling
establishments at 0.05 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). 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.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
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: November 26, 2014.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
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, revise the section
heading and add alphabetically the
following commodity to the table in
paragraph (a)(3) to read as follows:
■
§ 180.418 Cypermethrin and isomers
alpha-cypermethrin and zeta-cypermethrin;
tolerances for residues.
(a) * * *
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Parts per
million
Commodity
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Food commodities/feed commodities (other than those covered by a higher tolerance as a results of use on growing crops) in
food/feed handling establishments ..................................................................................................................................................
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[FR Doc. 2014–28934 Filed 12–9–14; 8:45 am]
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]]>Agencies
[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Rules and Regulations]
[Pages 73210-73213]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28934]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0601; FRL-9918-88]
Alpha-cypermethrin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of alpha-
cypermethrin in or on food
[[Page 73211]]
commodities/feed commodities in food/feed handling establishments. BASF
on behalf of Whitmire Micro-Gen Research Laboratories requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 10, 2014. Objections and
requests for hearings must be received on or before February 9, 2015,
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-2014-0601, is available at https://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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, 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. 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 https://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-2014-0601 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
February 9, 2015. 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-2014-0601, 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 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.
II. Summary of Petitioned-For Tolerance
In the Federal Register of September 5, 2014 (79 FR 53009) (FRL-
9914-98), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
3F8189) by BASF on behalf of Whitmire Micro-Gen Research Laboratories,
3568 Tree Court Industrial Blvd., St. Louis, MO 63122-6682. The
petition requested that 40 CFR part 180 be amended by establishing
tolerances for residues of the insecticide alpha-cypermethrin, in or on
food/feed handling establishments at 0.05 parts per million (ppm). That
document referenced a summary of the petition prepared by BASF on
behalf of Whitmire Micro-Gen Research Laboratories, the registrant,
which is available in the docket, https://www.regulations.gov. Comments
were received on the notice of filing. EPA's response to these comments
is discussed in Unit IV.C.
EPA has corrected the proposed commodity definition to read 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.
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
[[Page 73212]]
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 follows.
Alpha-cypermethrin is an enriched isomer of the pyrethroid
insecticide cypermethrin. In addition, zeta-cypermethrin is also an
enriched isomer of cypermethrin. 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 3 active ingredients are
essentially the same active from the mammalian toxicity perspective.
The recommended tolerance of 0.05 ppm associated with the food handling
establishment use of alpha-cypermethrin is at the same level as the one
currently established for zeta-cypermethrin. Based on the available
alpha-cypermethrin residue data submitted for the food handling
establishment use, this use will not result in alpha-cypermethrin
residues higher than 0.05 ppm and is the same as the existing tolerance
of 0.05 ppm established to support the food handling establishment uses
for zeta-cypermethrin. The existing dietary and aggregate risk
assessments already account for the impact of the existing zeta-
cypermethrin food handling establishment use (i.e. 100% crop treated
for all commodities without an existing tolerance). Therefore, the
addition of the food handling establishment use for alpha-cypermethrin
will have no impact on the dietary risk estimates, as they are already
covered in the existing dietary and aggregate risk assessments.
In the Federal Register of February 1, 2013 (78 FR 7266) (FRL-9376-
1), the EPA published a final rule to establish tolerances for residues
of the insecticide alpha-cypermethrin in or on alfalfa, hay at 15 ppm;
citrus, dried pulp at 1.8 ppm; citrus fruit, Group 10 at 0.35 ppm;
citrus, oil at 4.0 ppm; corn, grain; cottonseed; cucurbit vegetables,
Group 9; dried shelled pea and bean, except soybean, subgroup 6C;
edible podded legume vegetable, subgroup 6A; fruiting vegetables, Group
8; head and stem Brassica, subgroup 5A at 2.0 ppm; leafy vegetable,
except Brassica, Group 4 at 10 ppm; pop-corn; rice, grain at 1.5 ppm;
root and tuber vegetables, Group 1 at 0.1 ppm; sorghum, grain at 0.5
ppm; soybeans; succulent shelled pea and bean, subgroup 6B; sugar beet,
roots at 0.05 ppm; sugar beet, tops; sweet corn; tree nuts, Group 14;
and wheat, grain at 0.2 ppm. Since the publication of the February 1,
2013 final rule, the toxicity profile of alpha-cypermethrin has not
changed and since the food handling establishment use for alpha-
cypermethrin will have no impact on the dietary or aggregate risk
estimates, the risk assessments that supported the establishment of
those alpha-cypermethrin tolerances published in the February 1, 2013
Federal Register remain valid. Therefore, EPA is relying on those risk
assessments in order to support the new food handling tolerance for
alpha-cypermethrin.
For a detailed discussion of the aggregate risk assessments and
determination of safety for the food handling tolerance, please refer
to the February 1, 2013 Federal Register document and its supporting
documents, available at https://www.regulations.gov in Docket ID number
EPA-HQ-OPP-2010-0234. EPA relies upon those supporting risk assessments
and the findings made in the Federal Register document in support of
this final rule.
Based on the risk assessments and information described above, 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. Further information can also
be found in the document, ``Alpha-Cypermethrin--Human Health Risk
Assessment for Two New Proposed Products for Use in Commercial/
Residential Settings'' in docket ID number EPA-HQ-OPP-2014-0601.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate tolerance-enforcement methods are available in Pesticide
Analytical Manual (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).
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.
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.
There is no Codex MRL for residues of alpha-cypermethrin in or on
food commodities/feed commodities (other than those covered by a higher
tolerance as a results of use on growing crops) in food/feed handling
establishments.
C. Response to Comments
The EPA received 4 comments in response to this Notice of Filing.
Two commenters were opposed to increasing the amount of pesticides
being used and did not approve of the proposal. The Agency understands
the commenter's concerns and recognizes that some individuals believe
that certain pesticide chemicals should not be permitted in our food.
However, the existing legal framework provided by section 408 of the
FFDCA states that tolerances may be set when EPA determines that
aggregate exposure to that pesticide is safe, i.e., that there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue. When making this determination, EPA
considers the toxicity, including any potential carcinogenicity, of the
pesticide and all anticipated dietary exposures and all other exposures
for which there is reliable information. EPA also gives special
consideration to the potential susceptibility and exposures of infants
and children to the pesticide
[[Page 73213]]
chemical residue when making this determination. For alpha-
cypermethrin, the Agency has considered all the available data,
including all available data concerning the potential for
carcinogenicity and concluded after conducting a risk assessment, that
there is a reasonable certainty that no harm will result from aggregate
human exposure to alpha-cypermethrin.
Two additional commenters raised concerns regarding exposure to
bees. However, the proposed use is for pesticide applications to be
made indoors to food/feed handling establishments and therefore, there
should be no exposure to bees from the proposed application.
V. Conclusion
Therefore, the tolerance is established for residues of alpha-
cypermethrin, in or on food commodities/feed commodities (other than
those covered by a higher tolerance as a results of use on growing
crops) in food/feed handling establishments at 0.05 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). 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.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
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: November 26, 2014.
Susan Lewis,
Director, Registration Division, 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. 180.418, revise the section heading and add alphabetically
the following commodity to the table in paragraph (a)(3) to read as
follows:
Sec. 180.418 Cypermethrin and isomers alpha-cypermethrin and zeta-
cypermethrin; tolerances for residues.
(a) * * *
(3) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * * *
Food commodities/feed commodities (other than those 0.05
covered by a higher tolerance as a results of use on
growing crops) in food/feed handling establishments...
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2014-28934 Filed 12-9-14; 8:45 am]
BILLING CODE 6560-50-P
