Alkyl Amines Polyalkoxylates; Exemption From the Requirement of a Tolerance, 61515-61518 [2012-24776]
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Federal Register / Vol. 77, No. 196 / Wednesday, October 10, 2012 / Rules and Regulations
Subpart V—Maryland
particulate matter (PM2.5) standard’’ to
read as follows:
2. In § 52.1070, the table in paragraph
(e) is amended by adding at the end of
the table an entry for ‘‘2002 Base Year
Emissions Inventory for the 1997 fine
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
§ 52.1070
■
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Name of non-regulatory SIP revision
State submittal date
Applicable geographic area
*
*
*
*
2002 Base Year Emissions Inven- Maryland portion of the Washington
tory for the 1997 fine particulate DC–MD–VA 1997 PM2.5 nonmatter (PM2.5) standard.
attainment area.
3. In § 52.1075, paragraph (l) is added
to read as follows:
■
§ 52.1075
Base year emissions inventory.
*
*
*
*
*
(l) EPA approves as a revision to the
Maryland State Implementation Plan the
2002 base year emissions inventory for
the Maryland portion of the Washington
DC–MD–VA 1997 fine particulate matter
(PM2.5) nonattainment area submitted by
the Maryland Department of
Environment on April 3, 2008. The 2002
base year emissions inventory includes
emissions estimates that cover the
general source categories of point
sources, non-road mobile sources, area
sources, on-road mobile sources, and
biogenic sources. The pollutants that
comprise the inventory are nitrogen
oxides (NOX), volatile organic
compounds (VOCs), PM2.5, coarse
particles (PM10), ammonia (NH3), and
sulfur dioxide (SO2).
[FR Doc. 2012–24645 Filed 10–9–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2011–0949; FRL–9361–7]
Alkyl Amines Polyalkoxylates;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation amends the
exemption from the requirement of a
tolerance for residues alkyl amines
polyalkoxylates under 40 CFR 180.920
and 40 CFR 180.930 to include the
additional Chemical Abstract Service
Registry Number (CAS Reg. No.)
1266162–49–5. BASF Corporation
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
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SUMMARY:
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61515
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
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(e) EPA-approved nonregulatory and
quasi-regulatory material.
EPA approval date
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4/3/08 10/10/12 [Insert page number where
the document begins].
(FFDCA), requesting an amendment to
an existing requirement of a tolerance.
DATES: This regulation is effective
October 10, 2012. Objections and
requests for hearings must be received
on or before December 10, 2012, 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–2011–0949 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
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Fertich, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 347–8560; email address:
fertich.elizabeth@epa.gov.
SUPPLEMENTARY INFORMATION:
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Identification of plan.
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Additional
explanation
*
§ 52.1075(l)
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://
ecfr.gpoaccess.gov/cgi/t/text/textidx?&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–2011–0949 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 December 10, 2012. 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 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-
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Federal Register / Vol. 77, No. 196 / Wednesday, October 10, 2012 / Rules and Regulations
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CBI copy of your objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2011–0949, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.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. Petition for Exemption
In the Federal Register of March 14,
2012 (77 FR 15012) (FRL–9335–9), EPA
issued a notice pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (PP
1E7931) by BASF Corporation, 100
Campus Drive; Florham Park, NJ 07932.
The petition requested that 40 CFR
180.920 and 180.930 be amended by
modifying an exemption from the
requirement of a tolerance for residues
of N,N-Bis-a-ethyl-w-hydroxypoly(oxy1,2-ethanediyl) C8–C18 saturated and
unsaturated alkylamines; the poly(oxy1,2-ethanediyl) content is 2–60 moles
(CAS Reg. Nos. 10213–78–2, 25307–17–
9, 26635–92–7, 26635–93–8, 288259–
52–9, 58253–49–9, 61790–82–7, 61791–
14–8, 61791–24–0, 61791–26–2, 61791–
31–9, 61791–44–4, 68155–33–9, 68155–
39–5, 68155–40–8,70955–14–5, 73246–
96–5); herein referred to as alkyl amines
polyalkoxylates. Specifically, the
petition requested that the exemption
also include the alkyl amines
polyalkoxylate described by CAS Reg.
No. 1266162–49–5. That notice
referenced a summary of the petition
prepared by BASF Corporation, the
petitioner, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
In this petition, BASF Corporation
claims that the chemical represented by
CAS Reg. No. 1266162–49–5 (poly(oxy1,2-ethandiyl), a,a’-[[(2propylheptyl)imino]di-2,1ethanediyl]bis[w-hydroxy-) is covered
by the published tolerance exemption
for alkyl amines polyalkoxylates and
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that no further data or review is
required to amend the existing tolerance
exemption to include the additional
CAS Reg. No.
III. Inert Ingredient Definition
Inert ingredients are all ingredients
that are not active ingredients as defined
in 40 CFR 153.125 and include, but are
not limited to, the following types of
ingredients (except when they have a
pesticidal efficacy of their own):
Solvents such as alcohols and
hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty
acids; carriers such as clay and
diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
dispensers; microencapsulating agents;
and emulsifiers. The term ‘‘inert’’ is not
intended to imply nontoxicity; the
ingredient may or may not be
chemically active. Generally, EPA has
exempted inert ingredients from the
requirement of a tolerance based on the
low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for 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 * * *.’’
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated that the risks from
aggregate exposure to pesticide
chemical residues under reasonably
foreseeable circumstances will pose no
appreciable risks to human health. In
order to determine the risks from
aggregate exposure to pesticide inert
ingredients, the Agency considers the
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toxicity of the inert ingredient in
conjunction with possible exposure to
residues of the inert ingredient through
food, drinking water, and through other
exposures that occur as a result of
pesticide use in residential settings. If
EPA is able to determine that a finite
tolerance is not necessary to ensure that
there is a reasonable certainty that no
harm will result from aggregate
exposure to the inert ingredient, an
exemption from the requirement of a
tolerance may be established.
Consistent with FFDCA section
408(c)(2)(A), and the factors specified in
FFDCA section 408(c)(2)(B), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for alkyl amine
polyalkoxylates including exposure
resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with alkyl amine
polyalkoxylates follows.
The Agency agrees with the petitioner
that CAS Reg. No. 1266162–49–5 is an
alkyl amine polyalkoxylate similar to
the other alkyl amine polyalkoxylates
present in the exemption for N,N-Bis-aethyl-w-hydroxypoly(oxy-1,2ethanediyl) C8–C18 saturated and
unsaturated alkylamines; the poly(oxy1,2-ethanediyl) content is 2–60 moles
(CAS Reg. Nos. 10213–78–2, 25307–17–
9, 26635–92–7, 26635–93–8, 288259–
52–9, 58253–49–9, 61790–82–7, 61791–
14–8, 61791–24–0, 61791–26–2, 61791–
31–9, 61791–44–4, 68155–33–9, 68155–
39–5, 68155–40–8, 70955–14–5, 73246–
96–5). In 2009, in establishing the
exemption for the alkyl amine
polyalkoxylates, EPA assessed the safety
of the alkyl amine polyalkoxylates
generally using worst case exposure
assumptions. (74 FR 28616) (FRL–8418–
6). EPA concluded that that assessment
showed that exempting the alkyl amine
polyalkoxylates from the requirement
from a tolerance would be safe.
Inclusion of chemical described by the
CAS Reg. No. 1266162–49–5 in the risk
assessment for the alkyl amine
polyalkoxylates would in no way alter
that prior risk assessment given the
generic findings on toxicity and the
worst case exposure assumptions used
in that risk assessment. Accordingly,
based on the findings in that earlier
rule, EPA has determined that there is
a reasonable certainty that no harm to
any population subgroup, including
infants and children, will result from
aggregate exposure to alkyl amine
polyalkoxylates, including the chemical
described by the CAS Reg. No.
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Federal Register / Vol. 77, No. 196 / Wednesday, October 10, 2012 / Rules and Regulations
1266162–49–5, under reasonably
foreseeable circumstances. Therefore,
the amendment of an exemption from
tolerance under 40 CFR 180.920 and
180.930 for residues of alkyl amine
polyalkoxylates to include the chemical
described by the CAS Reg. No.
1266162–49–5 is safe under FFDCA
section 408.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency 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 an MRL for alkyl amine
polyalkoxylates.
VI. Conclusions
Therefore, the exemption from the
requirement of a tolerance under 40 CFR
180.920 and 180.930 for alkyl amine
polyalkoxylates is amended to include
CAS Reg. No. 1266162–49–5.
VII. Statutory and Executive Order
Reviews
This final rule establishes 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 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,
61517
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).
VIII. 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: September 28, 2012.
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 § 180.920, the table is amended
by revising the following inert
ingredient to read as follows:
■
§ 180.920 Inert ingredients use preharvest; exemptions from the requirement
of a tolerance.
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Inert ingredients
Limits
Uses
*
*
*
N,N-Bis-a-ethyl-w-hydroxypoly(oxy-1,2-ethanediyl) C8–C18 saturated and unsaturated alkylamines; the poly(oxy-1,2ethanediyl) content is 2–60 moles (CAS Reg. Nos. 10213–78–
2, 25307–17–9, 26635–92–7, 26635–93–8, 288259–52–9,
58253–49–9, 61790–82–7, 61791–14–8, 61791–24–0, 61791–
26–2, 61791–31–9, 61791–44–4, 68155–33–9, 68155–39–5,
68155–40–8,70955–14–5, 73246–96–5, 1266162–49–5).
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Not to exceed 25% in herbicide formulations and 10% in insecticide and fungicide formulations.
*
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Surfactants, related adjuvants of
surfactants.
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Federal Register / Vol. 77, No. 196 / Wednesday, October 10, 2012 / Rules and Regulations
Inert ingredients
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Limits
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Uses
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§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
3. In § 180.930, the table is amended
by revising the following inert
ingredient to read as follows:
■
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Inert ingredients
Limits
Uses
*
*
*
N,N-Bis-a-ethyl-w-hydroxypoly(oxy-1,2-ethanediyl) C8–C18 saturated and unsaturated alkylamines; the poly(oxy-1,2ethanediyl) content is 2–60 moles (CAS Reg. Nos. 10213–78–
2, 25307–17–9, 26635–92–7, 26635–93–8, 288259–52–9,
58253–49–9, 61790–82–7, 61791–14–8, 61791–24–0, 61791–
26–2, 61791–31–9, 61791–44–4, 68155–33–9, 68155–39–5,
68155–40–8,70955–14–5, 73246–96–5, 1266162–49–5).
*
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Not to exceed 25% in herbicide formulations and 10% in insecticide and fungicide formulations.
*
*
Surfactants, related adjuvants of
surfactants
*
*
*
[FR Doc. 2012–24776 Filed 10–9–12; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2008–0020; Internal
Agency Docket No. FEMA–8093]
Suspension of Community Eligibility
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
FEMA has scheduled one
community for suspension because of
its failure to adopt compliant floodplain
management regulations under the
National Flood Insurance Program
(NFIP). If documentation is received
from the community before the effective
suspension date, indicating it has
brought its floodplain management
program into compliance with the NFIP
requirements, FEMA will withdraw the
suspension.
DATES: Effective Dates: The effective
date of the community’s scheduled
suspension is the date listed in the
fourth column of the following table.
FOR FURTHER INFORMATION CONTACT:
David Stearrett, Federal Insurance and
Mitigation Administration, 1800 South
Bell Street Arlington, VA 20598–3072,
(202) 646–2953.
SUPPLEMENTARY INFORMATION: The
National Flood Insurance Program
(NFIP) enables property owners to
rmajette on DSK2TPTVN1PROD with RULES
SUMMARY:
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*
*
purchase flood insurance that is
generally not otherwise available. In
return, communities agree to adopt and
implement local floodplain management
regulations that contribute to protecting
lives and reducing the risk of property
damage from future flooding. Section
1315 of the National Flood Insurance
Act of 1968, as amended (42 U.S.C.
4022), prohibits flood insurance
coverage authorized under the National
Flood Insurance Program (42 U.S.C.
4001–4128) unless an appropriate
public body adopts adequate floodplain
management measures with effective
administration and enforcement
processes.
The community listed in this notice
currently has floodplain management
regulations that are scheduled to lapse
October 31, 2012. If the regulations
lapse as scheduled, the community will
no longer meet the NFIP requirements
set forth at 44 CFR Part 59 et seq. Under
44 CFR 59.24(d), a community will be
suspended from the NFIP for repealing
its floodplain management regulations,
allowing its regulations to lapse or
amending its regulations so that they no
longer meet the minimum requirements.
Accordingly, FEMA is suspending the
City of Philadelphia, Philadelphia
County, Pennsylvania (‘‘the City’’) on
the effective date in the fourth column
of the table. As of that date, the
purchase of new flood insurance
policies or the renewal of existing flood
insurance policies under the NFIP will
no longer be available.
FEMA will not suspend the City;
however, if the community submits the
documentation required by 44 CFR
59.24(d) to show that it has corrected
the deficiencies and remedied the
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*
*
violations identified in the Suspension
letter to the maximum extent possible.
This documentation must be received
by FEMA before the actual suspension
date. If the City successfully
demonstrates its compliance with NFIP
regulations, FEMA will continue its
eligibility for the sale of NFIP insurance.
In the interim, if you wish to determine
whether FEMA has suspended the City
on the suspension date, please contact
the FEMA Region III office at (215) 931–
5532. Additional information may also
be found at https://www.fema.gov/plan/
prevent/floodplain/nfipkeywords/
suspension.shtm.
FEMA identified the special flood
hazard areas (SFHAs) in this community
by publishing a Flood Insurance Rate
Map. The effective date of this map is
indicated in the last column of the table.
By law, no Federally regulated entity
may provide financial assistance for
acquisition or construction purposes for
property located in a SFHA unless the
community in which the property is
located is participating in the NFIP (42
U.S.C. 4106(a)). The prohibition against
certain types of Federal disaster
assistance also becomes effective for the
City on the date shown in the fourth
column (42 U.S.C. 4106(b)).
The Administrator finds that notice
and public comment procedure under 5
U.S.C. 553(b) is impracticable and
unnecessary because the community
listed in this final rule has been
adequately notified. The community
received a Letter from FEMA Region III
Administrator on March 2, 2012,
advising the City it must submit
compliant ordinance by May 31, 2012.
The city submitted its ordinance;
however, it has a sunset clause dated for
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Agencies
[Federal Register Volume 77, Number 196 (Wednesday, October 10, 2012)]
[Rules and Regulations]
[Pages 61515-61518]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24776]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0949; FRL-9361-7]
Alkyl Amines Polyalkoxylates; Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends the exemption from the requirement of a
tolerance for residues alkyl amines polyalkoxylates under 40 CFR
180.920 and 40 CFR 180.930 to include the additional Chemical Abstract
Service Registry Number (CAS Reg. No.) 1266162-49-5. BASF Corporation
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an amendment to an existing requirement of a
tolerance.
DATES: This regulation is effective October 10, 2012. Objections and
requests for hearings must be received on or before December 10, 2012,
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-2011-0949 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 the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Elizabeth Fertich, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 347-8560; email address:
fertich.elizabeth@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://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0949 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
December 10, 2012. 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 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-
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CBI copy of your objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0949, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.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. Petition for Exemption
In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-
9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide petition (PP 1E7931) by BASF
Corporation, 100 Campus Drive; Florham Park, NJ 07932. The petition
requested that 40 CFR 180.920 and 180.930 be amended by modifying an
exemption from the requirement of a tolerance for residues of N,N-Bis-
[alpha]-ethyl-[omega]-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated
and unsaturated alkylamines; the poly(oxy-1,2-ethanediyl) content is 2-
60 moles (CAS Reg. Nos. 10213-78-2, 25307-17-9, 26635-92-7, 26635-93-8,
288259-52-9, 58253-49-9, 61790-82-7, 61791-14-8, 61791-24-0, 61791-26-
2, 61791-31-9, 61791-44-4, 68155-33-9, 68155-39-5, 68155-40-8,70955-14-
5, 73246-96-5); herein referred to as alkyl amines polyalkoxylates.
Specifically, the petition requested that the exemption also include
the alkyl amines polyalkoxylate described by CAS Reg. No. 1266162-49-5.
That notice referenced a summary of the petition prepared by BASF
Corporation, the petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.
In this petition, BASF Corporation claims that the chemical
represented by CAS Reg. No. 1266162-49-5 (poly(oxy-1,2-ethandiyl),
[alpha],[alpha]'-[[(2-propylheptyl)imino]di-2,1-ethanediyl]bis[[omega]-
hydroxy-) is covered by the published tolerance exemption for alkyl
amines polyalkoxylates and that no further data or review is required
to amend the existing tolerance exemption to include the additional CAS
Reg. No.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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 * * *.''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert ingredient in conjunction with possible exposure to residues of
the inert ingredient through food, drinking water, and through other
exposures that occur as a result of pesticide use in residential
settings. If EPA is able to determine that a finite tolerance is not
necessary to ensure that there is a reasonable certainty that no harm
will result from aggregate exposure to the inert ingredient, an
exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for alkyl amine polyalkoxylates
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with alkyl
amine polyalkoxylates follows.
The Agency agrees with the petitioner that CAS Reg. No. 1266162-49-
5 is an alkyl amine polyalkoxylate similar to the other alkyl amine
polyalkoxylates present in the exemption for N,N-Bis-[alpha]-ethyl-
[omega]-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated and
unsaturated alkylamines; the poly(oxy-1,2-ethanediyl) content is 2-60
moles (CAS Reg. Nos. 10213-78-2, 25307-17-9, 26635-92-7, 26635-93-8,
288259-52-9, 58253-49-9, 61790-82-7, 61791-14-8, 61791-24-0, 61791-26-
2, 61791-31-9, 61791-44-4, 68155-33-9, 68155-39-5, 68155-40-8, 70955-
14-5, 73246-96-5). In 2009, in establishing the exemption for the alkyl
amine polyalkoxylates, EPA assessed the safety of the alkyl amine
polyalkoxylates generally using worst case exposure assumptions. (74 FR
28616) (FRL-8418-6). EPA concluded that that assessment showed that
exempting the alkyl amine polyalkoxylates from the requirement from a
tolerance would be safe. Inclusion of chemical described by the CAS
Reg. No. 1266162-49-5 in the risk assessment for the alkyl amine
polyalkoxylates would in no way alter that prior risk assessment given
the generic findings on toxicity and the worst case exposure
assumptions used in that risk assessment. Accordingly, based on the
findings in that earlier rule, EPA has determined that there is a
reasonable certainty that no harm to any population subgroup, including
infants and children, will result from aggregate exposure to alkyl
amine polyalkoxylates, including the chemical described by the CAS Reg.
No.
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1266162-49-5, under reasonably foreseeable circumstances. Therefore,
the amendment of an exemption from tolerance under 40 CFR 180.920 and
180.930 for residues of alkyl amine polyalkoxylates to include the
chemical described by the CAS Reg. No. 1266162-49-5 is safe under FFDCA
section 408.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency 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 an MRL for alkyl amine polyalkoxylates.
VI. Conclusions
Therefore, the exemption from the requirement of a tolerance under
40 CFR 180.920 and 180.930 for alkyl amine polyalkoxylates is amended
to include CAS Reg. No. 1266162-49-5.
VII. Statutory and Executive Order Reviews
This final rule establishes 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 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).
VIII. 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: September 28, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. In Sec. 180.920, the table is amended by revising the following
inert ingredient to read as follows:
Sec. 180.920 Inert ingredients use pre-harvest; exemptions from the
requirement of a tolerance.
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Inert ingredients Limits Uses
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N,N-Bis-[alpha]-ethyl-[omega]- Not to exceed 25% in Surfactants, related adjuvants of surfactants.
hydroxypoly(oxy-1,2-ethanediyl) C8- herbicide formulations
C18 saturated and unsaturated and 10% in insecticide
alkylamines; the poly(oxy-1,2- and fungicide
ethanediyl) content is 2-60 moles formulations.
(CAS Reg. Nos. 10213-78-2, 25307-17-
9, 26635-92-7, 26635-93-8, 288259-
52-9, 58253-49-9, 61790-82-7, 61791-
14-8, 61791-24-0, 61791-26-2, 61791-
31-9, 61791-44-4, 68155-33-9, 68155-
39-5, 68155-40-8,70955-14-5, 73246-
96-5, 1266162-49-5).
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3. In Sec. 180.930, the table is amended by revising the following
inert ingredient to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
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Inert ingredients Limits Uses
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N,N-Bis-[alpha]-ethyl-[omega]- Not to exceed 25% in Surfactants, related adjuvants of surfactants
hydroxypoly(oxy-1,2-ethanediyl) C8- herbicide formulations
C18 saturated and unsaturated and 10% in insecticide
alkylamines; the poly(oxy-1,2- and fungicide
ethanediyl) content is 2-60 moles formulations.
(CAS Reg. Nos. 10213-78-2, 25307-17-
9, 26635-92-7, 26635-93-8, 288259-
52-9, 58253-49-9, 61790-82-7, 61791-
14-8, 61791-24-0, 61791-26-2, 61791-
31-9, 61791-44-4, 68155-33-9, 68155-
39-5, 68155-40-8,70955-14-5, 73246-
96-5, 1266162-49-5).
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[FR Doc. 2012-24776 Filed 10-9-12; 8:45 am]
BILLING CODE 6560-50-P