Alcohols, C>14, 38096-38101 [2016-13794]
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38096
Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0858; FRL–9946–16]
Alcohols, C>14, Ethoxylated;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
I. General Information
This regulation amends an
exemption from the requirement of a
tolerance for residues of a-alkyl-whydroxypoly (oxypropylene) and/or
poly (oxyethylene) polymers where the
alkyl chain contains a minimum of six
carbons, and a alkyl-w-hydroxypoly
(oxypropylene) and/or poly
(oxyethylene) polymers where the alkyl
chain contains a minimum of six
carbons and a minimum number
average molecular weight (in amu) 1,100
(herein referred to as ‘‘AAAs’’ (alkyl
alcohol alkoxylates)) to include
alcohols, C>14, ethoxylated, Chemical
Abstract Service Registry Number (CAS
Reg. No.) 251553–55–6 when used as an
inert ingredient (surfactant) in pesticide
formulations. Baker Petrolite LLC
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting an amendment to
an existing exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of alcohols, C>14,
ethoxylated.
SUMMARY:
This regulation is effective June
13, 2016. Objections and requests for
hearings must be received on or before
August 12, 2016, 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–2015–0858, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
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DATES:
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information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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.
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–2015–0858 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 August 12, 2016. 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
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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–
2015–0858, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of August 5,
2009 (74 FR 38935) (FRL–8430–1), EPA
issued a document pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (PP
9E7534) by The Joint Inerts Task Force
(JITF), Cluster Support Team Number 1
(CST1), c/o CropLife America, 1156
15th Street NW., Suite 400, Washington,
DC 20005. The petition requested that
40 CFR 180.910, 40 CFR 180.930, 40
CFR 180.940(a), and 40 CFR 180.960 be
amended by establishing exemptions
from the requirement of a tolerance for
residues of a group of substances known
as AAAs. The exemptions narratively
describe the subject chemical as a-alkylw-hydroxypoly (oxypropylene) and/or
poly (oxyethylene) polymers where the
alkyl chain contains a minimum of six
carbons and specify the individual
chemicals covered by the exemptions by
a listing of CAS Reg. Nos. The current
petition seeks to expand these
exemptions by adding an additional
chemical, alcohols, C>14, ethoxylated,
identified by CAS Reg. No. 251553–55–
6.
In the Federal Register of March 16,
2016 (81 FR 14032) (FRL– 9942–86),
EPA issued a notice pursuant to section
408 of FFDCA, 21 U.S.C. 346A,
announcing the filing of a pesticide
petition (IN–10889) by Baker Petrolite
LLC (12645 W. Airport Blvd., Sugar
Land, TX 77478). The petition requested
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that 40 CFR 180.910, 180.930,
180.940(a), and 180.960 be amended by
modifying the exemption from the
requirement of a tolerance for residues
of AAAs by adding residues of alcohols,
C>14, ethoxylated which meets the
chemical identity a-alkyl-whydroxypoly (oxypropylene) and/or
poly (oxyethylene) polymers where the
alkyl chain contains a minimum of six
carbons. In cases where the minimum
number average molecular weight is
1,100 or more, the request is to include
the alcohols, C>14, ethoxylated under 40
CFR 180.960. For lower the molecular
weights the request is to amend the
existing exemption from the
requirement of a tolerance under 40 CFR
180.910, 180.930, and 180.940(a).
Based upon review of the data
supporting the petition, EPA has
confirmed that the requested CAS Reg.
No. is acceptable for consideration
under the currently approved
descriptor. This determination is based
on the Agency’s risk assessment which
can be found at https://
www.regulations.gov in document ‘‘IN–
10544. Requesting to Amend the
Exemption from the Requirement of a
Tolerance for a-alkyl-w-hydroxypoly
(oxypropylene) and/or poly
(oxyethylene) polymers where the alkyl
chain contains a minimum of six
carbons, and a-alkyl- w-hydroxypoly
(oxypropylene) and/or
poly(oxyethylene) polymers where the
alkyl chain contains a minimum of six
carbons and a minimum number
average molecular weight (in amu)
1,100, under 40 CFR 180.910, 180.930,
180.940(a) or 180.960.’’ in docket ID
number EPA–HQ–OPP–2013–2010.
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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.
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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 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 AAAs including
exposure resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with AAAs follows.
The Agency agrees with the petitioner
that alcohols, C>14, ethoxylated, CAS
Reg. No. 251553–55–6, is an AAA
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having a molecular structure
conforming to the chemical description
given in the tolerance exemption
expression, i.e., a-alkyl-w-hydroxypoly
(oxypropylene) and/or poly
(oxyethylene) polymers where the alkyl
chain contains a minimum of six
carbons and which do not contain
additional structural elements that are
not included within the tolerance
exemption expression description. In
2009, in establishing the exemption for
the AAAs, EPA assessed their safety
generally using worst case exposure
assumptions. (August 5, 2009 (74 FR
38935)). EPA concluded that that
assessment showed that exempting the
AAAs from the requirement from a
tolerance would be safe. Inclusion of
additional chemicals described above in
the risk assessment for the AAAs 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 AAAs, by including the
additional chemicals described above,
under reasonably foreseeable
circumstances. Therefore, the
amendment of an exemption from the
requirement of a tolerance under 40 CFR
180.910, 180.930, 180.940(a), and
180.960, for residues of AAAs to
include the chemical described above 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
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Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / 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.
The Codex not established a MRL for
AAAs.
C. Response to Comments
No comments have been received.
VI. Conclusions
Therefore, the exemptions from the
requirement of a tolerance under 40 CFR
180.910, 180.930, 180.940(a), and
180.960 for a-alkyl-w-hydroxypoly
(oxypropylene) and/or poly
(oxyethylene) polymers when used as
an inert ingredient as a surfactant in
pesticide formulations applied to
growing crops, animals, or food contact
surfaces are amended to add the CAS
Reg. No. 251553–55–6 to the description
of AAAs.
VII. Statutory and Executive Order
Reviews
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This final rule establishes a tolerance
under section 408(d) of FFDCA 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
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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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104–4).
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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), Public Law 104–113, section
12(d) (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: May 31, 2016.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, the table is amended
by revising the following inert
ingredient(s) to read as follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
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Inert ingredients
Limits
Uses
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a-alkyl-w-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains
a minimum of six carbons (CAS Reg. Nos.: 9002–92–0; 9004–95–9; 9004–98–2; 9005–00–9; 9035–
85–2; 9038–29–3; 9038–43–1; 9040–05–5; 9043–30–5; 9087–53–0; 25190–05–0; 24938–91–8;
25231–21–4; 251553–55–6; 26183–52–8; 26468–86–0; 26636–39–5; 27252–75–1; 27306–79–2;
31726–34–8; 34398–01–1; 34398–05–5; 37251–67–5; 37311–00–5; 37311–01–6; 37311–02–7;
37311–04–9; 39587–22–9; 50861–66–0; 52232–09–4; 52292–17–8; 52609–19–5; 57679–21–7;
59112–62–8; 60828–78–6; 61702–78–1; 61725–89–1; 61791–13–7; 61791–20–6; 61791–28–4;
61804–34–0; 61827–42–7; 61827–84–7; 62648–50–4; 63303–01–5; 63658–45–7; 63793–60–2;
64366–70–7; 64415–24–3; 64415–25–4; 64425–86–1; 65104–72–5; 65150–81–4; 66455–14–9:
66455–15–0; 67254–71–1; 67763–08–0; 68002–96–0; 68002–97–1; 68131–39–5; 68131–40–8;
68154–96–1; 68154–97–2; 68154–98–3; 68155–01–1; 68213–23–0; 68213–24–1; 68238–81–3;
68238–82–4; 68409–58–5; 68409–59–6; 68439–30–5; 68439–45–2; 68439–46–3; 68439–48–5;
68439–49–6; 68439–50–9; 68439–51–0; 68439–53–2; 68439–54–3; 68458–88–8;.
68526–94–3; 68526–95–4; 68551–12–2; 68551–13–3; 68551–14–4; 68603–20–3; 68603–25–8;
68920–66–1; 68920–69–4; 68937–66–6; 68951–67–7; 68954–94–9; 68987–81–5; 68991–48–0;
69011–36–5; 69013–18–9; 69013–19–0; 69227–20–9; 69227–21–0; 69227–22–1; 69364–63–2;
70750–27–5; 70879–83–3; 70955–07–6; 71011–10–4; 71060–57–6; 71243–46–4; 72066–65–0;
72108–90–8; 72484–69–6; 72854–13–8; 72905–87–4; 73018–31–2; 73049–34–0; 74432–13–6;
74499–34–6; 78330–19–5; 78330–20–8; 78330–21–9; 78330–23–1; 79771–03–2; 84133–50–6;
85422–93–1; 97043–91–9; 97953–22–5; 102782–43–4; 103331–86–8; 103657–84–7; 103657–85–8;
103818–93–5; 103819–03–0; 106232–83–1; 111905–54–5; 116810–31–2; 116810–32–3; 116810–
33–4; 120313–48–6; 120944–68–5; 121617–09–2; 126646–02–4; 126950–62–7; 127036–24–2;
139626–71–4; 152231–44–2; 154518–36–2; 157627–86–6; 157627–88–8; 157707–41–0; 157707–
43–2; 159653–49–3; 160875–66–1; 160901–20–2; 160901–09–7; 160901–19–9; 161025–21–4;
161025–22–5; 166736–08–9; 169107–21–5; 172588–43–1; 176022–76–7; 196823–11–7; 287935–
46–0; 288260–45–7; 303176–75–2; 954108–36–2)
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Surfactants, related adjuvants of surfactants.
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Inert ingredients
Limits
Uses
*
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a-alkyl-w-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains
a minimum of six carbons (CAS Reg. Nos.: 9002–92–0; 9004–95–9; 9004–98–2; 9005–00–9; 9035–
85–2; 9038–29–3; 9038–43–1; 9040–05–5; 9043–30–5; 9087–53–0; 25190–05–0; 24938–91–8;
25231–21–4; 251553–55–6; 26183–52–8; 26468–86–0; 26636–39–5; 27252–75–1; 27306–79–2;
31726–34–8; 34398–01–1; 34398–05–5; 37251–67–5; 37311–00–5; 37311–01–6; 37311–02–7;
37311–04–9; 39587–22–9; 50861–66–0; 52232–09–4; 52292–17–8; 52609–19–5; 57679–21–7;
59112–62–8; 60828–78–6; 61702–78–1; 61725–89–1; 61791–13–7; 61791–20–6; 61791–28–4;
61804–34–0; 61827–42–7; 61827–84–7; 62648–50–4; 63303–01–5; 63658–45–7; 63793–60–2;
64366–70–7; 64415–24–3; 64415–25–4; 64425–86–1; 65104–72–5; 65150–81–4; 66455–14–9:
66455–15–0; 67254–71–1; 67763–08–0; 68002–96–0; 68002–97–1; 68131–39–5; 68131–40–8;
68154–96–1; 68154–97–2; 68154–98–3; 68155–01–1; 68213–23–0; 68213–24–1; 68238–81–3;
68238–82–4; 68409–58–5; 68409–59–6; 68439–30–5; 68439–45–2; 68439–46–3; 68439–48–5;
68439–49–6; 68439–50–9; 68439–51–0; 68439–53–2; 68439–54–3; 68458–88–8; 68526–94–3;
68526–95–4; 68551–12–2; 68551–13–3; 68551–14–4; 68603–20–3; 68603–25–8; 68920–66–1;
68920–69–4; 68937–66–6; 68951–67–7; 68954–94–9; 68987–81–5; 68991–48–0; 69011–36–5;
69013–18–9; 69013–19–0; 69227–20–9; 69227–21–0; 69227–22–1; 69364–63–2; 70750–27–5;
70879–83–3; 70955–07–6; 71011–10–4; 71060–57–6; 71243–46–4; 72066–65–0; 72108–90–8;
72484–69–6; 72854–13–8; 72905–87–4; 73018–31–2; 73049–34–0; 74432–13–6; 74499–34–6;
78330–19–5; 78330–20–8; 78330–21–9; 78330–23–1; 79771–03–2; 84133–50–6; 85422–93–1;
97043–91–9; 97953–22–5; 102782–43–4; 103331–86–8; 103657–84–7; 103657–85–8; 103818–93–5;
103819–03–0; 106232–83–1; 111905–54–5; 116810–31–2; 116810–32–3; 116810–33–4; 120313–
48–6; 120944–68–5; 121617–09–2; 126646–02–4; 126950–62–7; 127036–24–2; 139626–71–4;
152231–44–2; 154518–36–2; 157627–86–6; 157627–88–8; 157707–41–0; 157707–43–2; 159653–
49–3; 160875–66–1; 160901–20–2; 160901–09–7; 160901–19–9; 161025–21–4; 161025–22–5;
166736–08–9; 169107–21–5; 172588–43–1; 176022–76–7; 196823–11–7; 287935–46–0; 288260–
45–7; 303176–75–2; 954108–36–2).
*
..................
*
Surfactants, related adjuvants of surfactants.
3. In § 180.930, the table is amended
by revising the following inert
ingredients to read as follows:
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§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
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Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Rules and Regulations
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
4. In § 180.940, the table is amended
by revising the following entry to the
table in paragraph (a):
■
(a) * * *
Pesticide chemical
CAS Reg. No.
*
*
a-alkyl-w-hydroxypoly (oxypropylene) and/
or poly (oxyethylene) polymers where
the alkyl chain contains a minimum of
six carbons (CAS Reg. No 251553–55–
6).
*
*
*
*
9002–92–0; 9004–95–9; 9004–98–2; 9005–00–9; 9035–85–2; 9038–29–3; 9038–43–1;
9040–05–5; 9043–30–5; 9087–53–0; 25190–05–0; 24938–91–8; 25231–21–4;
251553–55–6; 26183–52–8; 26468–86–0; 26636–39–5; 27252–75–1; 27306–79–2;
31726–34–8; 34398–01–1; 34398–05–5; 37251–67–5; 37311–00–5; 37311–01–6;
37311–02–7; 37311–04–9; 39587–22–9; 50861–66–0; 52232–09–4; 52292–17–8;
52609–19–5; 57679–21–7; 59112–62–8; 60828–78–6; 61702–78–1; 61725–89–1;
61791–13–7; 61791–20–6; 61791–28–4; 61804–34–0; 61827–42–7; 61827–84–7;
62648–50–4; 63303–01–5; 63658–45–7; 63793–60–2; 64366–70–7; 64415–24–3;
64415–25–4; 64425–86–1; 65104–72–5; 65150–81–4; 66455–14–9: 66455–15–0;
67254–71–1; 67763–08–0; 68002–96–0; 68002–97–1; 68131–39–5; 68131–40–8;
68154–96–1; 68154–97–2; 68154–98–3; 68155–01–1; 68213–23–0; 68213–24–1;
68238–81–3; 68238–82–4; 68409–58–5; 68409–59–6; 68439–30–5; 68439–45–2;
68439–46–3; 68439–48–5; 68439–49–6; 68439–50–9; 68439–51–0; 68439–53–2;
68439–54–3; 68458–88–8; 68526–94–3; 68526–95–4; 68551–12–2; 68551–13–3;
68551–14–4; 68603–20–3; 68603–25–8; 68920–66–1; 68920–69–4; 68937–66–6;
68951–67–7; 68954–94–9; 68987–81–5; 68991–48–0; 69011–36–5; 69013–18–9;
69013–19–0; 69227–20–9; 69227–21–0; 69227–22–1; 69364–63–2; 70750–27–5;
70879–83–3; 70955–07–6; 71011–10–4; 71060–57–6; 71243–46–4; 72066–65–0;
72108–90–8; 72484–69–6; 72854–13–8; 72905–87–4; 73018–31–2; 73049–34–0;
74432–13–6; 74499–34–6; 78330–19–5; 78330–20–8; 78330–21–9; 78330–23–1;
79771–03–2; 84133–50–6; 85422–93–1; 97043–91–9; 97953–22–5; 102782–43–4;
103331–86–8; 103657–84–7; 103657–85–8; 103818–93–5; 103819–03–0; 106232–
83–1; 111905–54–5; 116810–31–2; 116810–32–3; 116810–33–4; 120313–48–6;
120944–68–5; 121617–09–2; 126646–02–4; 126950–62–7; 127036–24–2; 139626–
71–4; 152231–44–2; 154518–36–2; 157627–86–6; 157627–88–8; 157707–41–0;
157707–43–2; 159653–49–3; 160875–66–1; 160901–20–2; 160901–09–7; 160901–
19–9; 161025–21–4; 161025–22–5; 166736–08–9; 169107–21–5; 172588–43–1;
176022–76–7; 196823–11–7; 287935–46–0; 288260–45–7; 303176–75–2; 954108–
36–2.
*
*
*
*
*
*
*
*
*
Limits
*
*
*
*
§ 180.960; Polymers; exemptions from the
requirement of a tolerance.
5. In § 180.960, the table is amended
by revising the following entry to read
as follows:
■
CAS No.
*
*
a-alkyl-w-hydroxypoly (oxypropylene) and/or
poly (oxyethylene) polymers where the alkyl
chain contains a minimum of six carbons and
a minimum number average molecular weight
(in amu) 1,100
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Polymer
*
*
*
*
*
9002–92–0; 9004–95–9; 9004–98–2; 9005–00–9; 9035–85–2; 9038–29–3; 9038–43–1; 9040–
05–5; 9043–30–5; 9087–53–0; 25190–05–0; 24938–91–8; 25231–21–4; 251553–55–6;
26183–52–8; 26468–86–0; 26636–39–5; 27252–75–1; 27306–79–2; 31726–34–8; 34398–
01–1; 34398–05–5; 37251–67–5; 37311–00–5; 37311–01–6; 37311–02–7; 37311–04–9;
39587–22–9; 50861–66–0; 52232–09–4; 52292–17–8; 52609–19–5; 57679–21–7; 59112–
62–8; 60828–78–6; 61702–78–1; 61725–89–1; 61791–13–7; 61791–20–6; 61791–28–4;
61804–34–0; 61827–42–7; 61827–84–7; 62648–50–4; 63303–01–5; 63658–45–7; 63793–
60–2; 64366–70–7; 64415–24–3; 64415–25–4; 64425–86–1; 65104–72–5; 65150–81–4;
66455–14–9: 66455–15–0; 67254–71–1; 67763–08–0; 68002–96–0; 68002–97–1; 68131–
39–5; 68131–40–8; 68154–96–1; 68154–97–2; 68154–98–3; 68155–01–1; 68213–23–0;
68213–24–1; 68238–81–3; 68238–82–4; 68409–58–5; 68409–59–6; 68439–30–5; 68439–
45–2; 68439–46–3; 68439–48–5; 68439–49–6; 68439–50–9; 68439–51–0; 68439–53–2;
68439–54–3; 68458–88–8; 68526–94–3; 68526–95–4; 68551–12–2; 68551–13–3; 68551–
14–4; 68603–20–3; 68603–25–8; 68920–66–1; 68920–69–4; 68937–66–6; 68951–67–7;
68954–94–9; 68987–81–5; 68991–48–0; 69011–36–5; 69013–18–9; 69013–19–0; 69227–
20–9; 69227–21–0; 69227–22–1; 69364–63–2; 70750–27–5; 70879–83–3; 70955–07–6;
71011–10–4; 71060–57–6; 71243–46–4; 72066–65–0; 72108–90–8; 72484–69–6; 72854–
13–8; 72905–87–4; 73018–31–2; 73049–34–0; 74432–13–6; 74499–34–6; 78330–19–5;
78330–20–8; 78330–21–9; 78330–23–1; 79771–03–2; 84133–50–6; 85422–93–1; 97043–
91–9; 97953–22–5; 102782–43–4; 103331–86–8; 103657–84–7; 103657–85–8; 103818–93–
5; 103819–03–0; 106232–83–1; 111905–54–5; 116810–31–2; 116810–32–3; 116810–33–4;
120313–48–6; 120944–68–5; 121617–09–2; 126646–02–4; 126950–62–7; 127036–24–2;
139626–71–4; 152231–44–2; 154518–36–2; 157627–86–6; 157627–88–8; 157707–41–0;
157707–43–2; 159653–49–3; 160875–66–1; 160901–20–2; 160901–09–7; 160901–19–9;
161025–21–4; 161025–22–5; 166736–08–9; 169107–21–5; 172588–43–1; 176022–76–7;
196823–11–7; 287935–46–0; 288260–45–7; 303176–75–2; 954108–36–2.
*
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Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Rules and Regulations
[FR Doc. 2016–13794 Filed 6–10–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0350; FRL–9946–48]
D-glucurono-6-deoxy-L-manno-Dglucan, Acetate, Calcium Magnesium
Potassium Sodium Salt (Diutan Gum);
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 D-glucurono-6deoxy-L-manno-D-glucan, acetate,
calcium magnesium potassium sodium
salt (diutan gum) Chemical Abstract
Service Registration Number ((CAS Reg.
No.) 595585–15–2) when used as an
inert ingredient stabilizer/suspension
agent applied to crops pre- and postharvest and to food contact surfaces.
Keller and Heckman on behalf of CP
Kelco U.S., Inc submitted a petition to
EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting
establishment of an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of D-glucurono-6-deoxy-Lmanno-D-glucan, acetate, calcium
magnesium potassium sodium salt
(diutan gum).
DATES: This regulation is effective June
13, 2016. Objections and requests for
hearings must be received on or before
August 12, 2016, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0350, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
mstockstill on DSK3G9T082PROD with RULES
ADDRESSES:
VerDate Sep<11>2014
16:33 Jun 10, 2016
Jkt 238001
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 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. To access the OCSPP test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’
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–2015–0350 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 August 12, 2016. Addresses for
mail and hand delivery of objections
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
38101
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–
2015–0350, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of Monday,
April 25, 2016 (81 FR 24046) (FRL–
9944–86), EPA issued a document
pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a
pesticide petition (PP IN–10815) by
Keller and Heckman LLP (1001 G Street
NW., Suite 500 West, Washington, DC
20001), on behalf of CP Kelco U.S., Inc
(3100 Cumberland Blvd., Suite 600,
Atlanta, GA 30339). The petition
requested that 40 CFR 180.910 and 40
CFR 180.940 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of D-glucurono-6-deoxy-L-manno-Dglucan, acetate, calcium magnesium
potassium sodium salt (diutan gum)
(CAS Reg. No. 595585–15–2) when used
as an inert ingredient stabilizer/
suspension agent in pesticide
formulations applied to crops pre- and
post-harvest and to food contact
surfaces. That document referenced a
summary of the petition prepared by
Keller and Heckman on behalf of CP
Kelco U.S., Inc., the petitioner, which is
available in the docket, https://
www.regulations.gov. There were no
E:\FR\FM\13JNR1.SGM
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Agencies
[Federal Register Volume 81, Number 113 (Monday, June 13, 2016)]
[Rules and Regulations]
[Pages 38096-38101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13794]
[[Page 38096]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0858; FRL-9946-16]
Alcohols, C>14, Ethoxylated; Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends an exemption from the requirement of a
tolerance for residues of [alpha]-alkyl-[omega]-hydroxypoly
(oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain
contains a minimum of six carbons, and [alpha] alkyl-[omega]-
hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the
alkyl chain contains a minimum of six carbons and a minimum number
average molecular weight (in amu) 1,100 (herein referred to as ``AAAs''
(alkyl alcohol alkoxylates)) to include alcohols, C>14,
ethoxylated, Chemical Abstract Service Registry Number (CAS Reg. No.)
251553-55-6 when used as an inert ingredient (surfactant) in pesticide
formulations. Baker Petrolite LLC submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment
to an existing exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of alcohols, C>14, ethoxylated.
DATES: This regulation is effective June 13, 2016. Objections and
requests for hearings must be received on or before August 12, 2016,
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-2015-0858, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 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-2015-0858 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
August 12, 2016. 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-2015-0858, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of August 5, 2009 (74 FR 38935) (FRL-8430-
1), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 9E7534) by The
Joint Inerts Task Force (JITF), Cluster Support Team Number 1 (CST1),
c/o CropLife America, 1156 15th Street NW., Suite 400, Washington, DC
20005. The petition requested that 40 CFR 180.910, 40 CFR 180.930, 40
CFR 180.940(a), and 40 CFR 180.960 be amended by establishing
exemptions from the requirement of a tolerance for residues of a group
of substances known as AAAs. The exemptions narratively describe the
subject chemical as [alpha]-alkyl-[omega]-hydroxypoly (oxypropylene)
and/or poly (oxyethylene) polymers where the alkyl chain contains a
minimum of six carbons and specify the individual chemicals covered by
the exemptions by a listing of CAS Reg. Nos. The current petition seeks
to expand these exemptions by adding an additional chemical, alcohols,
C>14, ethoxylated, identified by CAS Reg. No. 251553-55-6.
In the Federal Register of March 16, 2016 (81 FR 14032) (FRL- 9942-
86), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346A, announcing the filing of a pesticide petition (IN-10889) by Baker
Petrolite LLC (12645 W. Airport Blvd., Sugar Land, TX 77478). The
petition requested
[[Page 38097]]
that 40 CFR 180.910, 180.930, 180.940(a), and 180.960 be amended by
modifying the exemption from the requirement of a tolerance for
residues of AAAs by adding residues of alcohols, C>14,
ethoxylated which meets the chemical identity [alpha]-alkyl-[omega]-
hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the
alkyl chain contains a minimum of six carbons. In cases where the
minimum number average molecular weight is 1,100 or more, the request
is to include the alcohols, C>14, ethoxylated under 40 CFR
180.960. For lower the molecular weights the request is to amend the
existing exemption from the requirement of a tolerance under 40 CFR
180.910, 180.930, and 180.940(a).
Based upon review of the data supporting the petition, EPA has
confirmed that the requested CAS Reg. No. is acceptable for
consideration under the currently approved descriptor. This
determination is based on the Agency's risk assessment which can be
found at https://www.regulations.gov in document ``IN-10544. Requesting
to Amend the Exemption from the Requirement of a Tolerance for [alpha]-
alkyl-[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene)
polymers where the alkyl chain contains a minimum of six carbons, and
[alpha]-alkyl- [omega]-hydroxypoly (oxypropylene) and/or
poly(oxyethylene) polymers where the alkyl chain contains a minimum of
six carbons and a minimum number average molecular weight (in amu)
1,100, under 40 CFR 180.910, 180.930, 180.940(a) or 180.960.'' in
docket ID number EPA-HQ-OPP-2013-2010.
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 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 AAAs including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with AAAs follows.
The Agency agrees with the petitioner that alcohols,
C>14, ethoxylated, CAS Reg. No. 251553-55-6, is an AAA
having a molecular structure conforming to the chemical description
given in the tolerance exemption expression, i.e., [alpha]-alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers
where the alkyl chain contains a minimum of six carbons and which do
not contain additional structural elements that are not included within
the tolerance exemption expression description. In 2009, in
establishing the exemption for the AAAs, EPA assessed their safety
generally using worst case exposure assumptions. (August 5, 2009 (74 FR
38935)). EPA concluded that that assessment showed that exempting the
AAAs from the requirement from a tolerance would be safe. Inclusion of
additional chemicals described above in the risk assessment for the
AAAs 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 AAAs, by including the
additional chemicals described above, under reasonably foreseeable
circumstances. Therefore, the amendment of an exemption from the
requirement of a tolerance under 40 CFR 180.910, 180.930, 180.940(a),
and 180.960, for residues of AAAs to include the chemical described
above 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
[[Page 38098]]
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 not established a MRL for AAAs.
C. Response to Comments
No comments have been received.
VI. Conclusions
Therefore, the exemptions from the requirement of a tolerance under
40 CFR 180.910, 180.930, 180.940(a), and 180.960 for [alpha]-alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers
when used as an inert ingredient as a surfactant in pesticide
formulations applied to growing crops, animals, or food contact
surfaces are amended to add the CAS Reg. No. 251553-55-6 to the
description of AAAs.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104-4).
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), Public Law 104-113, section 12(d) (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: May 31, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.910, the table is amended by revising the following
inert ingredient(s) to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
[[Page 38099]]
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
[alpha]-alkyl-[omega]-hydroxypoly .......... Surfactants,
(oxypropylene) and/or poly (oxyethylene) related
polymers where the alkyl chain contains a adjuvants of
minimum of six carbons (CAS Reg. Nos.: surfactants.
9002-92-0; 9004-95-9; 9004-98-2; 9005-00-
9; 9035-85-2; 9038-29-3; 9038-43-1; 9040-
05-5; 9043-30-5; 9087-53-0; 25190-05-0;
24938-91-8; 25231-21-4; 251553-55-6;
26183-52-8; 26468-86-0; 26636-39-5; 27252-
75-1; 27306-79-2; 31726-34-8; 34398-01-1;
34398-05-5; 37251-67-5; 37311-00-5; 37311-
01-6; 37311-02-7; 37311-04-9; 39587-22-9;
50861-66-0; 52232-09-4; 52292-17-8; 52609-
19-5; 57679-21-7; 59112-62-8; 60828-78-6;
61702-78-1; 61725-89-1; 61791-13-7; 61791-
20-6; 61791-28-4; 61804-34-0; 61827-42-7;
61827-84-7; 62648-50-4; 63303-01-5; 63658-
45-7; 63793-60-2; 64366-70-7; 64415-24-3;
64415-25-4; 64425-86-1; 65104-72-5; 65150-
81-4; 66455-14-9: 66455-15-0; 67254-71-1;
67763-08-0; 68002-96-0; 68002-97-1; 68131-
39-5; 68131-40-8; 68154-96-1; 68154-97-2;
68154-98-3; 68155-01-1; 68213-23-0; 68213-
24-1; 68238-81-3; 68238-82-4; 68409-58-5;
68409-59-6; 68439-30-5; 68439-45-2; 68439-
46-3; 68439-48-5; 68439-49-6; 68439-50-9;
68439-51-0; 68439-53-2; 68439-54-3; 68458-
88-8;.
68526-94-3; 68526-95-4; 68551-12-2; 68551-
13-3; 68551-14-4; 68603-20-3; 68603-25-8;
68920-66-1; 68920-69-4; 68937-66-6; 68951-
67-7; 68954-94-9; 68987-81-5; 68991-48-0;
69011-36-5; 69013-18-9; 69013-19-0; 69227-
20-9; 69227-21-0; 69227-22-1; 69364-63-2;
70750-27-5; 70879-83-3; 70955-07-6; 71011-
10-4; 71060-57-6; 71243-46-4; 72066-65-0;
72108-90-8; 72484-69-6; 72854-13-8; 72905-
87-4; 73018-31-2; 73049-34-0; 74432-13-6;
74499-34-6; 78330-19-5; 78330-20-8; 78330-
21-9; 78330-23-1; 79771-03-2; 84133-50-6;
85422-93-1; 97043-91-9; 97953-22-5;
102782-43-4; 103331-86-8; 103657-84-7;
103657-85-8; 103818-93-5; 103819-03-0;
106232-83-1; 111905-54-5; 116810-31-2;
116810-32-3; 116810-33-4; 120313-48-6;
120944-68-5; 121617-09-2; 126646-02-4;
126950-62-7; 127036-24-2; 139626-71-4;
152231-44-2; 154518-36-2; 157627-86-6;
157627-88-8; 157707-41-0; 157707-43-2;
159653-49-3; 160875-66-1; 160901-20-2;
160901-09-7; 160901-19-9; 161025-21-4;
161025-22-5; 166736-08-9; 169107-21-5;
172588-43-1; 176022-76-7; 196823-11-7;
287935-46-0; 288260-45-7; 303176-75-2;
954108-36-2)
* * * * * * *
------------------------------------------------------------------------
0
3. In Sec. 180.930, the table is amended by revising the following
inert ingredients to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
[alpha]-alkyl-[omega]-hydroxypoly .......... Surfactants,
(oxypropylene) and/or poly (oxyethylene) related
polymers where the alkyl chain contains a adjuvants of
minimum of six carbons (CAS Reg. Nos.: surfactants.
9002-92-0; 9004-95-9; 9004-98-2; 9005-00-
9; 9035-85-2; 9038-29-3; 9038-43-1; 9040-
05-5; 9043-30-5; 9087-53-0; 25190-05-0;
24938-91-8; 25231-21-4; 251553-55-6;
26183-52-8; 26468-86-0; 26636-39-5; 27252-
75-1; 27306-79-2; 31726-34-8; 34398-01-1;
34398-05-5; 37251-67-5; 37311-00-5; 37311-
01-6; 37311-02-7; 37311-04-9; 39587-22-9;
50861-66-0; 52232-09-4; 52292-17-8; 52609-
19-5; 57679-21-7; 59112-62-8; 60828-78-6;
61702-78-1; 61725-89-1; 61791-13-7; 61791-
20-6; 61791-28-4; 61804-34-0; 61827-42-7;
61827-84-7; 62648-50-4; 63303-01-5; 63658-
45-7; 63793-60-2; 64366-70-7; 64415-24-3;
64415-25-4; 64425-86-1; 65104-72-5; 65150-
81-4; 66455-14-9: 66455-15-0; 67254-71-1;
67763-08-0; 68002-96-0; 68002-97-1; 68131-
39-5; 68131-40-8; 68154-96-1; 68154-97-2;
68154-98-3; 68155-01-1; 68213-23-0; 68213-
24-1; 68238-81-3; 68238-82-4; 68409-58-5;
68409-59-6; 68439-30-5; 68439-45-2; 68439-
46-3; 68439-48-5; 68439-49-6; 68439-50-9;
68439-51-0; 68439-53-2; 68439-54-3; 68458-
88-8; 68526-94-3; 68526-95-4; 68551-12-2;
68551-13-3; 68551-14-4; 68603-20-3; 68603-
25-8; 68920-66-1; 68920-69-4; 68937-66-6;
68951-67-7; 68954-94-9; 68987-81-5; 68991-
48-0; 69011-36-5; 69013-18-9; 69013-19-0;
69227-20-9; 69227-21-0; 69227-22-1; 69364-
63-2; 70750-27-5; 70879-83-3; 70955-07-6;
71011-10-4; 71060-57-6; 71243-46-4; 72066-
65-0; 72108-90-8; 72484-69-6; 72854-13-8;
72905-87-4; 73018-31-2; 73049-34-0; 74432-
13-6; 74499-34-6; 78330-19-5; 78330-20-8;
78330-21-9; 78330-23-1; 79771-03-2; 84133-
50-6; 85422-93-1; 97043-91-9; 97953-22-5;
102782-43-4; 103331-86-8; 103657-84-7;
103657-85-8; 103818-93-5; 103819-03-0;
106232-83-1; 111905-54-5; 116810-31-2;
116810-32-3; 116810-33-4; 120313-48-6;
120944-68-5; 121617-09-2; 126646-02-4;
126950-62-7; 127036-24-2; 139626-71-4;
152231-44-2; 154518-36-2; 157627-86-6;
157627-88-8; 157707-41-0; 157707-43-2;
159653-49-3; 160875-66-1; 160901-20-2;
160901-09-7; 160901-19-9; 161025-21-4;
161025-22-5; 166736-08-9; 169107-21-5;
172588-43-1; 176022-76-7; 196823-11-7;
287935-46-0; 288260-45-7; 303176-75-2;
954108-36-2).
* * * * * * *
------------------------------------------------------------------------
[[Page 38100]]
0
4. In Sec. 180.940, the table is amended by revising the following
entry to the table in paragraph (a):
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
(a) * * *
----------------------------------------------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
----------------------------------------------------------------------------------------------------------------
* * * * * * *
[alpha]-alkyl-[omega]-hydroxypoly 9002-92-0; 9004-95-9; 9004-98-2; 9005-00-9; 9035-85-2;
(oxypropylene) and/or poly (oxyethylene) 9038-29-3; 9038-43-1; 9040-05-5; 9043-30-5; 9087-53-0;
polymers where the alkyl chain contains a 25190-05-0; 24938-91-8; 25231-21-4; 251553-55-6; 26183-
minimum of six carbons (CAS Reg. No 251553- 52-8; 26468-86-0; 26636-39-5; 27252-75-1; 27306-79-2;
55-6). 31726-34-8; 34398-01-1; 34398-05-5; 37251-67-5; 37311-
00-5; 37311-01-6; 37311-02-7; 37311-04-9; 39587-22-9;
50861-66-0; 52232-09-4; 52292-17-8; 52609-19-5; 57679-
21-7; 59112-62-8; 60828-78-6; 61702-78-1; 61725-89-1;
61791-13-7; 61791-20-6; 61791-28-4; 61804-34-0; 61827-
42-7; 61827-84-7; 62648-50-4; 63303-01-5; 63658-45-7;
63793-60-2; 64366-70-7; 64415-24-3; 64415-25-4; 64425-
86-1; 65104-72-5; 65150-81-4; 66455-14-9: 66455-15-0;
67254-71-1; 67763-08-0; 68002-96-0; 68002-97-1; 68131-
39-5; 68131-40-8; 68154-96-1; 68154-97-2; 68154-98-3;
68155-01-1; 68213-23-0; 68213-24-1; 68238-81-3; 68238-
82-4; 68409-58-5; 68409-59-6; 68439-30-5; 68439-45-2;
68439-46-3; 68439-48-5; 68439-49-6; 68439-50-9; 68439-
51-0; 68439-53-2; 68439-54-3; 68458-88-8; 68526-94-3;
68526-95-4; 68551-12-2; 68551-13-3; 68551-14-4; 68603-
20-3; 68603-25-8; 68920-66-1; 68920-69-4; 68937-66-6;
68951-67-7; 68954-94-9; 68987-81-5; 68991-48-0; 69011-
36-5; 69013-18-9; 69013-19-0; 69227-20-9; 69227-21-0;
69227-22-1; 69364-63-2; 70750-27-5; 70879-83-3; 70955-
07-6; 71011-10-4; 71060-57-6; 71243-46-4; 72066-65-0;
72108-90-8; 72484-69-6; 72854-13-8; 72905-87-4; 73018-
31-2; 73049-34-0; 74432-13-6; 74499-34-6; 78330-19-5;
78330-20-8; 78330-21-9; 78330-23-1; 79771-03-2; 84133-
50-6; 85422-93-1; 97043-91-9; 97953-22-5; 102782-43-4;
103331-86-8; 103657-84-7; 103657-85-8; 103818-93-5;
103819-03-0; 106232-83-1; 111905-54-5; 116810-31-2;
116810-32-3; 116810-33-4; 120313-48-6; 120944-68-5;
121617-09-2; 126646-02-4; 126950-62-7; 127036-24-2;
139626-71-4; 152231-44-2; 154518-36-2; 157627-86-6;
157627-88-8; 157707-41-0; 157707-43-2; 159653-49-3;
160875-66-1; 160901-20-2; 160901-09-7; 160901-19-9;
161025-21-4; 161025-22-5; 166736-08-9; 169107-21-5;
172588-43-1; 176022-76-7; 196823-11-7; 287935-46-0;
288260-45-7; 303176-75-2; 954108-36-2.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
5. In Sec. 180.960, the table is amended by revising the following
entry to read as follows:
Sec. 180.960; Polymers; exemptions from the requirement of a
tolerance.
------------------------------------------------------------------------
Polymer CAS No.
------------------------------------------------------------------------
* * * * * * *
[alpha]-alkyl-[omega]- 9002-92-0; 9004-95-9; 9004-98-2; 9005-00-
hydroxypoly (oxypropylene) 9; 9035-85-2; 9038-29-3; 9038-43-1; 9040-
and/or poly (oxyethylene) 05-5; 9043-30-5; 9087-53-0; 25190-05-0;
polymers where the alkyl 24938-91-8; 25231-21-4; 251553-55-6;
chain contains a minimum of 26183-52-8; 26468-86-0; 26636-39-5;
six carbons and a minimum 27252-75-1; 27306-79-2; 31726-34-8;
number average molecular 34398-01-1; 34398-05-5; 37251-67-5;
weight (in amu) 1,100 37311-00-5; 37311-01-6; 37311-02-7;
37311-04-9; 39587-22-9; 50861-66-0;
52232-09-4; 52292-17-8; 52609-19-5;
57679-21-7; 59112-62-8; 60828-78-6;
61702-78-1; 61725-89-1; 61791-13-7;
61791-20-6; 61791-28-4; 61804-34-0;
61827-42-7; 61827-84-7; 62648-50-4;
63303-01-5; 63658-45-7; 63793-60-2;
64366-70-7; 64415-24-3; 64415-25-4;
64425-86-1; 65104-72-5; 65150-81-4;
66455-14-9: 66455-15-0; 67254-71-1;
67763-08-0; 68002-96-0; 68002-97-1;
68131-39-5; 68131-40-8; 68154-96-1;
68154-97-2; 68154-98-3; 68155-01-1;
68213-23-0; 68213-24-1; 68238-81-3;
68238-82-4; 68409-58-5; 68409-59-6;
68439-30-5; 68439-45-2; 68439-46-3;
68439-48-5; 68439-49-6; 68439-50-9;
68439-51-0; 68439-53-2; 68439-54-3;
68458-88-8; 68526-94-3; 68526-95-4;
68551-12-2; 68551-13-3; 68551-14-4;
68603-20-3; 68603-25-8; 68920-66-1;
68920-69-4; 68937-66-6; 68951-67-7;
68954-94-9; 68987-81-5; 68991-48-0;
69011-36-5; 69013-18-9; 69013-19-0;
69227-20-9; 69227-21-0; 69227-22-1;
69364-63-2; 70750-27-5; 70879-83-3;
70955-07-6; 71011-10-4; 71060-57-6;
71243-46-4; 72066-65-0; 72108-90-8;
72484-69-6; 72854-13-8; 72905-87-4;
73018-31-2; 73049-34-0; 74432-13-6;
74499-34-6; 78330-19-5; 78330-20-8;
78330-21-9; 78330-23-1; 79771-03-2;
84133-50-6; 85422-93-1; 97043-91-9;
97953-22-5; 102782-43-4; 103331-86-8;
103657-84-7; 103657-85-8; 103818-93-5;
103819-03-0; 106232-83-1; 111905-54-5;
116810-31-2; 116810-32-3; 116810-33-4;
120313-48-6; 120944-68-5; 121617-09-2;
126646-02-4; 126950-62-7; 127036-24-2;
139626-71-4; 152231-44-2; 154518-36-2;
157627-86-6; 157627-88-8; 157707-41-0;
157707-43-2; 159653-49-3; 160875-66-1;
160901-20-2; 160901-09-7; 160901-19-9;
161025-21-4; 161025-22-5; 166736-08-9;
169107-21-5; 172588-43-1; 176022-76-7;
196823-11-7; 287935-46-0; 288260-45-7;
303176-75-2; 954108-36-2.
* * * * * * *
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[[Page 38101]]
[FR Doc. 2016-13794 Filed 6-10-16; 8:45 am]
BILLING CODE 6560-50-P