Ethyl-2E,4Z-Decadienoate (Pear Ester); Exemption From the Requirement of a Tolerance, 53051-53054 [2013-21019]
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53051
Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations
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 no
Codex MRLs established for residues of
halosulfuron-methyl in/on any
commodity.
wreier-aviles on DSK5TPTVN1PROD with RULES
V. Conclusion
Therefore, tolerances are established
for residues of the herbicide
halosulfuron-methyl, methyl 5-[(4,6dimethoxy-2-pyrimidiny)amino]
carbonylaminosulfonyl]-3-chloro-1methyl-1H-pyrazole-4-carboxylate,
including its metabolites and
degradates, in or on the commodities
artichoke at 0.05 ppm and caneberry
subgroup 13–07A 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
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Jkt 229001
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: August 14, 2013.
Lois Rossi,
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 § 180.479, add alphabetically the
following commodities to the table in
paragraph (a)(2) to read as follows:
■
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§ 180.479 Halosulfuron-methyl; tolerances
for residues.
(a) * * *
(2) * * *
Parts per
million
Commodity
*
*
*
*
Artichoke .....................................
*
0.05
*
*
*
*
Caneberry subgroup 13–07A .....
*
0.05
*
*
*
*
*
*
*
*
*
*
[FR Doc. 2013–20906 Filed 8–27–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2011–1018; FRL–9396–8]
Ethyl-2E,4Z-Decadienoate (Pear Ester);
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of the biochemical
pesticide ethyl-2E,4Z-decadienoate
(pear ester) in or on all food
commodities. This regulation eliminates
the need to establish a maximum
permissible level for residues of ethyl2E,4Z-decadienoate (pear ester).
DATES: This regulation is effective
August 28, 2013. Objections and
requests for hearings must be received
on or before October 28, 2013, 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–2011–1018, 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), EPA West
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
SUMMARY:
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Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Gina
Burnett, Biopesticides and Pollution
Prevention Division (7511P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001;
telephone number: (703) 605–0513;
email address: burnett.gina@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 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.
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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–2011–1018 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 October 28, 2013. 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
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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–
2011–1018, 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.htm.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Background and Statutory Findings
In the Federal Register of March 14,
2012 (77 FR 15012) (FRL–9335–9), EPA
issued a notice pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
tolerance petition (PP 1F7901) by
Wagner Regulatory Associates, Inc. (the
Petitioner), on behalf of Bedoukian
Research, Inc., 21 Finance Drive,
Danbury, CT 06810. The petition
requested that 40 CFR part 180 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of ethyl-2E,4Z-decadienoate
(pear ester). The notice referenced a
summary of the petition prepared by the
Petitioner, which is available in the
docket, https://www.regulations.gov. No
relevant comments were received on
this notice of filing.
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement of a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(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
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residential settings, but does not include
occupational exposure. Pursuant to
FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in FFDCA section
408(b)(2)(C), which require 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 . . . . ’’ Additionally,
FFDCA section 408(b)(2)(D) requires
that the Agency consider ‘‘available
information concerning the cumulative
effects of a particular pesticide’s
residues’’ and ‘‘other substances that
have a common mechanism of toxicity.’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. First,
EPA determines the toxicity of
pesticides. Second, EPA examines
exposure to the pesticide through food,
drinking water, and through other
exposures that occur as a result of
pesticide use in residential settings.
III. Toxicological Profile
Consistent with FFDCA section
408(b)(2)(D), EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness and reliability, and the
relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children.
A. Overview of Pear Ester
Ethyl-2E,4Z-decadienoate (pear ester)
is a naturally occurring, volatile
substance emitted from mature, ripening
fruit, that is attractive to the codling
moth (CM), Cydia pomonella, a major
agricultural pest of pome fruit
worldwide. Male and female moths are
attracted to pear ester and fly to the
ripening fruit, where they mate and lay
their eggs. Synthetic pear ester is
structurally and functionally identical
to the natural compound, and its
intended pesticidal use is to disrupt CM
mating behavior by attracting the moths
away from the fruit, reducing their
chances of finding mates and laying
eggs in fruit orchards.
B. Biochemical Pesticide Toxicology
Data Requirements
All applicable mammalian toxicology
data requirements supporting the
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Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations
petition to exempt residues of pear ester
from the requirement of a tolerance in
or on all food commodities have been
fulfilled. No toxic endpoints were
identified in studies conducted and data
obtained from open technical literature.
Moreover, pear ester is not likely a
mutagen or developmental toxicant.
There are no known effects on
endocrine systems via oral, dermal, or
inhalation routes of exposure. For a
more in-depth synopses of the data
upon which EPA relied and its human
health risk assessment based on that
data can be found in the document
entitled, ‘‘Federal Food, Drug, and
Cosmetic Act (FFDCA) Considerations
for Ethyl-2E,4Z-decadienoate (Pear
Ester),’’ available in the docket for this
action as described under ADDRESSES.
IV. Aggregate Exposures
In examining aggregate exposure,
FFDCA section 408 directs EPA to
consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational exposures, including
drinking water from ground water or
surface water and exposure through
pesticide use in gardens, lawns, or
buildings (residential and other indoor
uses).
A. Dietary Exposure
The proposed use patterns may result
in dietary exposure to pear ester,
although its residues are not expected to
be any greater than that of current
exposure due to use of pear ester as a
flavoring agent. No significant exposure
via drinking water is expected when
pear ester is used according to the
product label directions. The reason for
this conclusion is that pear ester is
applied at low rates, degrades rapidly,
and is not directly applied to water.
Should exposure occur, however,
minimal to no risk is expected for the
general population, including infants
and children, due to the low toxicity of
pear ester as demonstrated in the data
submitted and evaluated by the Agency.
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B. Other Non-Occupational Exposure
Non-occupational exposure is not
expected because pear ester will be
applied as a codling moth mating
disruptor for agricultural purposes only.
V. Cumulative Effects From Substances
With a Common Mechanism of Toxicity
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
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substances that have a common
mechanism of toxicity.’’
EPA has determined pear ester to
have a non-toxic mode of action, and
does not appear to produce any toxic
metabolites; therefore, 408(b)(2)(D)(v)
does not apply. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site at https://
www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S.
Population, Infants and Children
FFDCA section 408(b)(2)(C) provides
that, in considering the establishment of
a tolerance or tolerance exemption for a
pesticide chemical residue, EPA shall
assess the available information about
consumption patterns among infants
and children, special susceptibility of
infants and children to pesticide
chemical residues, and the cumulative
effects on infants and children of the
residues and other substances with a
common mechanism of toxicity. In
addition, FFDCA section 408(b)(2)(C)
provides that EPA shall apply an
additional tenfold (10X) margin of safety
for infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the database on toxicity
and exposure, unless EPA determines
that a different margin of safety will be
safe for infants and children. This
additional margin of safety is commonly
referred to as the Food Quality
Protection Act Safety Factor. In
applying this provision, EPA either
retains the default value of 10X, or uses
a different additional or no safety factor
when reliable data are available to
support a different additional or no
safety factor. As part of its qualitative
assessment, EPA evaluated the available
toxicity and exposure data on pear ester
and considered its validity,
completeness, and reliability, as well as
the relationship of this information to
human risk. EPA considers the toxicity
database to be complete and has
identified no residual uncertainty with
regard to prenatal and postnatal toxicity
or exposure. No hazard was identified
based on the available studies. Based
upon its evaluation, EPA concludes that
there are no threshold effects of concern
to infants, children, or adults when pear
ester is applied as a mating disruptor of
codling moth and used in accordance
with label directions and good
agricultural practices. As a result, EPA
concludes that no additional margin of
exposure (safety) is necessary.
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53053
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes because EPA
is establishing an exemption from the
requirement of a tolerance without any
numerical limitation.
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.
The Codex has not established a MRL
for ethyl-2E,4Z-decadienoate (pear
ester).
VIII. Conclusion
EPA concludes that there is a
reasonable certainty that no harm will
result to the U.S. population, including
infants and children, from aggregate
exposure to residues of ethyl-2E,4Zdecadienoate (pear ester). EPA is
therefore establishing an exemption
from the requirement of a tolerance for
residues of ethyl-2E,4Z-decadienoate
(pear ester) in or on all food
commodities when applied as a codling
moth mating disruptor and used in
accordance with good agricultural
practices.
IX. Statutory and Executive Order
Reviews
This final rule establishes an
exemption from the requirement of a
tolerance 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
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wreier-aviles on DSK5TPTVN1PROD with RULES
53054
Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations
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 exemption 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).
X. 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.
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14:52 Aug 27, 2013
Jkt 229001
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: August 22, 2013.
Steven Bradbury,
Director, 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. Add § 180.1323 to subpart D to read
as follows:
■
§ 180.1323 Ethyl-2E,4Z-decadienoate (Pear
Ester); exemption from the requirement of
a tolerance.
An exemption from the requirement
of a tolerance is established for residues
of the biochemical pesticide, ethyl2E,4Z-decadienoate (pear ester), in or on
all food commodities, when used in
accordance with label directions and
good agricultural practices.
[FR Doc. 2013–21019 Filed 8–27–13; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[FCC 13–105; MB Docket No. 02–266; RM–
10557]
Radio Broadcasting Services;
Chillicothe, Dublin, Hillsboro, and
Marion, Ohio
Federal Communications
Commission.
ACTION: Final rule; application for
review.
AGENCY:
This document denies an
Application for Review filed by the
Committee for Competitive Columbus
Radio (‘‘Committee’’) of a Memorandum
Opinion and Order in this proceeding,
which denied the Committee’s Petition
for Reconsideration of an earlier Bureau
action, granting the reallotment, class
downgrade, and change of community
of license of an Ohio FM station. The
document finds that the Bureau
SUMMARY:
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properly applied the Commission’s
then-existing policy of not considering
compliance with the multiple
ownership rule at the allotment stage.
DATES: August 28, 2013.
FOR FURTHER INFORMATION CONTACT:
Andrew J. Rhodes, Media Bureau, (202)
418–2700.
SUPPLEMENTARY INFORMATION: This is a
synopsis of the Commission’s
Memorandum Opinion and Order, MM
Docket No. 02–266, adopted July 31,
2013, and released August 1, 2013. The
full text of this Commission decision is
available for inspection and copying
during normal business hours in the
FCC Reference Information Center
(Room CY–A257), 445 12th Street, SW.,
Washington, DC 20554. The complete
text of this decision may also be
purchased from the Commission’s copy
contractor, Best Copy and Printing, Inc.,
Portals II, 445 12th Street, SW., Room
CY–B402, Washington, DC 20554,
telephone 1–800–378–3160 or
www.BCPIWEB.com.
In the Report and Order in this
proceeding, the Bureau granted a
Petition for Rulemaking filed by Clear
Channel Communications for the
reallotment, downgrade in class of
channel, and change of community of
license for its Station WCGX(FM)
(formerly WMRN–FM) from Channel
295B at Marion, Ohio to Channel 294B1
at Dublin, Ohio, over the objection of
the Committee. See 70 FR 19337 (April
13, 2005). The Committee had argued
that the reallotment to Dublin could not
be implemented because it would
violate the local radio ownership rule.
However, the Report and Order rejected
this argument, explaining that multiple
ownership issues are not considered in
FM allotment proceedings. The
Committee sought reconsideration on
the same ground, and the Bureau denied
the petition in the Memorandum
Opinion and Order. See 71 FR 40927
(July 19, 2006).
On review, the Commission finds
that, contrary to the Committee’s
contention, the Bureau did not err in
deferring the issue of compliance with
the multiple ownership rule until an
implementing application was filed
because such an approach is consistent
with then-existing policy. Additionally,
the Commission concludes that the
Bureau did not err in referring to Station
WCGX(FM) as formerly licensed to
Marion because the Report and Order
did modify the Station WCGX(FM)
license to specify Dublin. However, that
modification had no immediate impact
on competition in the Columbus radio
market as Clear Channel was required to
file an implementing application and
E:\FR\FM\28AUR1.SGM
28AUR1
]]>Agencies
[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Rules and Regulations]
[Pages 53051-53054]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21019]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-1018; FRL-9396-8]
Ethyl-2E,4Z-Decadienoate (Pear Ester); Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the biochemical pesticide ethyl-2E,4Z-
decadienoate (pear ester) in or on all food commodities. This
regulation eliminates the need to establish a maximum permissible level
for residues of ethyl-2E,4Z-decadienoate (pear ester).
DATES: This regulation is effective August 28, 2013. Objections and
requests for hearings must be received on or before October 28, 2013,
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-2011-1018, 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), EPA West 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
[[Page 53052]]
the visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Gina Burnett, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (703) 605-0513; email
address: burnett.gina@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 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-2011-1018 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
October 28, 2013. 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-2011-1018, 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.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-
9), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP
1F7901) by Wagner Regulatory Associates, Inc. (the Petitioner), on
behalf of Bedoukian Research, Inc., 21 Finance Drive, Danbury, CT
06810. The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of ethyl-2E,4Z-decadienoate (pear ester). The notice
referenced a summary of the petition prepared by the Petitioner, which
is available in the docket, https://www.regulations.gov. No relevant
comments were received on this notice of filing.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require 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 . .
. . '' Additionally, FFDCA section 408(b)(2)(D) requires that the
Agency consider ``available information concerning the cumulative
effects of a particular pesticide's residues'' and ``other substances
that have a common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability,
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
A. Overview of Pear Ester
Ethyl-2E,4Z-decadienoate (pear ester) is a naturally occurring,
volatile substance emitted from mature, ripening fruit, that is
attractive to the codling moth (CM), Cydia pomonella, a major
agricultural pest of pome fruit worldwide. Male and female moths are
attracted to pear ester and fly to the ripening fruit, where they mate
and lay their eggs. Synthetic pear ester is structurally and
functionally identical to the natural compound, and its intended
pesticidal use is to disrupt CM mating behavior by attracting the moths
away from the fruit, reducing their chances of finding mates and laying
eggs in fruit orchards.
B. Biochemical Pesticide Toxicology Data Requirements
All applicable mammalian toxicology data requirements supporting
the
[[Page 53053]]
petition to exempt residues of pear ester from the requirement of a
tolerance in or on all food commodities have been fulfilled. No toxic
endpoints were identified in studies conducted and data obtained from
open technical literature. Moreover, pear ester is not likely a mutagen
or developmental toxicant. There are no known effects on endocrine
systems via oral, dermal, or inhalation routes of exposure. For a more
in-depth synopses of the data upon which EPA relied and its human
health risk assessment based on that data can be found in the document
entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations
for Ethyl-2E,4Z-decadienoate (Pear Ester),'' available in the docket
for this action as described under ADDRESSES.
IV. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
A. Dietary Exposure
The proposed use patterns may result in dietary exposure to pear
ester, although its residues are not expected to be any greater than
that of current exposure due to use of pear ester as a flavoring agent.
No significant exposure via drinking water is expected when pear ester
is used according to the product label directions. The reason for this
conclusion is that pear ester is applied at low rates, degrades
rapidly, and is not directly applied to water. Should exposure occur,
however, minimal to no risk is expected for the general population,
including infants and children, due to the low toxicity of pear ester
as demonstrated in the data submitted and evaluated by the Agency.
B. Other Non-Occupational Exposure
Non-occupational exposure is not expected because pear ester will
be applied as a codling moth mating disruptor for agricultural purposes
only.
V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA has determined pear ester to have a non-toxic mode of action,
and does not appear to produce any toxic metabolites; therefore,
408(b)(2)(D)(v) does not apply. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at https://www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S. Population, Infants and Children
FFDCA section 408(b)(2)(C) provides that, in considering the
establishment of a tolerance or tolerance exemption for a pesticide
chemical residue, EPA shall assess the available information about
consumption patterns among infants and children, special susceptibility
of infants and children to pesticide chemical residues, and the
cumulative effects on infants and children of the residues and other
substances with a common mechanism of toxicity. In addition, FFDCA
section 408(b)(2)(C) provides that EPA shall apply an additional
tenfold (10X) margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the database on toxicity and exposure, unless EPA
determines that a different margin of safety will be safe for infants
and children. This additional margin of safety is commonly referred to
as the Food Quality Protection Act Safety Factor. In applying this
provision, EPA either retains the default value of 10X, or uses a
different additional or no safety factor when reliable data are
available to support a different additional or no safety factor. As
part of its qualitative assessment, EPA evaluated the available
toxicity and exposure data on pear ester and considered its validity,
completeness, and reliability, as well as the relationship of this
information to human risk. EPA considers the toxicity database to be
complete and has identified no residual uncertainty with regard to
prenatal and postnatal toxicity or exposure. No hazard was identified
based on the available studies. Based upon its evaluation, EPA
concludes that there are no threshold effects of concern to infants,
children, or adults when pear ester is applied as a mating disruptor of
codling moth and used in accordance with label directions and good
agricultural practices. As a result, EPA concludes that no additional
margin of exposure (safety) is necessary.
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes
because EPA is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
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.
The Codex has not established a MRL for ethyl-2E,4Z-decadienoate
(pear ester).
VIII. Conclusion
EPA concludes that there is a reasonable certainty that no harm
will result to the U.S. population, including infants and children,
from aggregate exposure to residues of ethyl-2E,4Z-decadienoate (pear
ester). EPA is therefore establishing an exemption from the requirement
of a tolerance for residues of ethyl-2E,4Z-decadienoate (pear ester) in
or on all food commodities when applied as a codling moth mating
disruptor and used in accordance with good agricultural practices.
IX. Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirement of a
tolerance 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
[[Page 53054]]
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 exemption 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).
X. 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: August 22, 2013.
Steven Bradbury,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Add Sec. 180.1323 to subpart D to read as follows:
Sec. 180.1323 Ethyl-2E,4Z-decadienoate (Pear Ester); exemption from
the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of the biochemical pesticide, ethyl-2E,4Z-decadienoate (pear
ester), in or on all food commodities, when used in accordance with
label directions and good agricultural practices.
[FR Doc. 2013-21019 Filed 8-27-13; 8:45 am]
BILLING CODE 6560-50-P
