Polyester Polyol Polymers; Tolerance Exemption, 76640-76644 [2015-30510]
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Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0465; FRL–9936–91]
Polyester Polyol Polymers; Tolerance
Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of D-glucitol,
polymer with decanedioic acid,
octadecanoate; D-glucitol, polymer with
decanedioic acid, docosanoate; Dglucitol, polymer with decanedioic acid,
docosanoate; D-glucitol, polymer with
decanedioic acid and 1,3-propanediol,
docosanoate; D-glucitol, polymer with
decanedioic acid and 1,3-propanediol,
octadecanoate; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid
and sorbitol; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid,
1,3-propanediol and stearic acid; fatty
acids, C18-unsatd., dimers, polymers
with sorbitol and stearic acid; fatty
acids, C18-unsatd., dimers, polymers
with 1,3-propanediol, sorbitol and
stearic acid; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid
and sorbitol; and fatty acids, C18unsatd., dimers, polymers with
docosanoic acid, 1,3-propanediol and
sorbitol when used as inert ingredients
in a pesticide chemical formulation.
Spring Trading Co., on behalf of Croda
Inc., submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an exemption
from the requirement of a tolerance.
This regulation eliminates the need to
establish a maximum permissible level
for residues of D-glucitol, polymer with
decanedioic acid, octadecanoate; Dglucitol, polymer with decanedioic acid,
docosanoate; D-glucitol, polymer with
decanedioic acid, docosanoate; Dglucitol, polymer with decanedioic acid
and 1,3-propanediol, docosanoate; Dglucitol, polymer with decanedioic acid
and 1,3-propanediol, octadecanoate;
fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid and
sorbitol; fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid, 1,3propanediol and stearic acid; fatty acids,
C18-unsatd., dimers, polymers with
sorbitol and stearic acid; fatty acids, C18unsatd., dimers, polymers with 1,3propanediol, sorbitol and stearic acid;
fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid and
sorbitol; and fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid,
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SUMMARY:
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1,3-propanediol and sorbitol on food or
feed commodities.
DATES: This regulation is effective
December 10, 2015. Objections and
requests for hearings must be received
on or before February 8, 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–2015–0465, 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-
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C. 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–2015–0465 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before February 8, 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–
2015–0465, 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. Background and Statutory Findings
In the Federal Register of August 26,
2015 (80 FR 51763) (FRL–9931–74),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the receipt of a pesticide
petition (PP IN–10830) filed by Spring
Trading Company, 203 Dogwood Trl.,
Magnolia, TX 77354 (on behalf of Croda,
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Inc., 315 Cherry Ln., New Castle, DE
19720). The petition requested that 40
CFR 180.960 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of D-glucitol, polymer with decanedioic
acid, octadecanoate (CAS Reg. No.
68562–93–6); D-glucitol, polymer with
decanedioic acid, docosanoate (CAS
Reg. No. 943440–33–3); D-glucitol,
polymer with decanedioic acid,
docosanoate (CAS Reg. No. 1681043–
28–6); D-glucitol, polymer with
decanedioic acid and 1,3-propanediol,
docosanoate (CAS Reg. No. 1681043–
31–1); D-glucitol, polymer with
decanedioic acid and 1,3-propanediol,
octadecanoate (CAS Reg. No. 1681043–
33–3); fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid and
sorbitol (CAS Reg. No. 1685270–83–0);
fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid, 1,3propanediol and stearic acid (CAS Reg.
No. 1685270–84–1); fatty acids, C18unsatd., dimers, polymers with sorbitol
and stearic acid (CAS Reg. No.
1685270–99–8); fatty acids, C18-unsatd.,
dimers, polymers with 1,3-propanediol,
sorbitol and stearic acid (CAS Reg, No.
1685271–01–5); fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid
and sorbitol (CAS Reg. No. 1685271–02–
6); and fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid, 1,3propanediol and sorbitol. That
document included a summary of the
petition prepared by the petitioner and
solicited comments on the petitioner’s
request. No comments were received by
the Agency in response to the notice of
filing. 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 exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and
use 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 an
exemption from the requirement of 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 . . .’’ and specifies
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factors EPA is to consider in
establishing an exemption.
III. Risk Assessment and Statutory
Findings
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be shown 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(b)(2)(D), EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness and reliability and the
relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children. In the
case of certain chemical substances that
are defined as polymers, the Agency has
established a set of criteria to identify
categories of polymers expected to
present minimal or no risk. The
definition of a polymer is given in 40
CFR 723.250(b) and the exclusion
criteria for identifying these low-risk
polymers are described in 40 CFR
723.250(d).
D-Glucitol, polymer with decanedioic
acid, octadecanoate; D-glucitol, polymer
with decanedioic acid, docosanoate; Dglucitol, polymer with decanedioic acid,
docosanoate; D-glucitol, polymer with
decanedioic acid and 1,3-propanediol,
docosanoate; D-glucitol, polymer with
decanedioic acid and 1,3-propanediol,
octadecanoate; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid
and sorbitol; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid,
1,3-propanediol and stearic acid; fatty
acids, C18-unsatd., dimers, polymers
with sorbitol and stearic acid; fatty
acids, C18-unsatd., dimers, polymers
with 1,3-propanediol, sorbitol and
stearic acid; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid
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and sorbitol; and fatty acids, C18unsatd., dimers, polymers with
docosanoic acid, 1,3-propanediol and
sorbitol conform to the definition of a
polymer given in 40 CFR 723.250(b) and
meet the following criteria that are used
to identify low-risk polymers.
1. The polymer is not a cationic
polymer nor is it reasonably anticipated
to become a cationic polymer in a
natural aquatic environment.
2. The polymer does contain as an
integral part of its composition the
atomic elements carbon, hydrogen, and
oxygen.
3. The polymer does not contain as an
integral part of its composition, except
as impurities, any element other than
those listed in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed
nor can it be reasonably anticipated to
substantially degrade, decompose, or
depolymerize.
5. The polymer is manufactured or
imported from monomers and/or
reactants that are already included on
the TSCA Chemical Substance
Inventory or manufactured under an
applicable TSCA section 5 exemption.
6. The polymer is not a water
absorbing polymer with a number
average molecular weight (MW) greater
than or equal to 10,000 Daltons.
Additionally, the polymer also meets
as required the following exemption
criteria specified in 40 CFR 723.250(e).
7. The polymer’s minimum number
average molecular weight is greater
1,000 Daltons. The oligomer content is
less than 10% (w/w) below a number
average molecular weight of 500 and
less than 25% (w/w) below a number
average molecular weight of 1,000.
Thus, D-glucitol, polymer with
decanedioic acid, octadecanoate; Dglucitol, polymer with decanedioic acid,
docosanoate; D-glucitol, polymer with
decanedioic acid, docosanoate; Dglucitol, polymer with decanedioic acid
and 1,3-propanediol, docosanoate; Dglucitol, polymer with decanedioic acid
and 1,3-propanediol, octadecanoate;
fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid and
sorbitol; fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid, 1,3propanediol and stearic acid; fatty acids,
C18-unsatd., dimers, polymers with
sorbitol and stearic acid; fatty acids, C18unsatd., dimers, polymers with 1,3propanediol, sorbitol and stearic acid;
fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid and
sorbitol; and fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid,
1,3-propanediol and sorbitol meet the
criteria for a polymer to be considered
low risk under 40 CFR 723.250. Based
on their conformance to the criteria in
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this unit, no mammalian toxicity is
anticipated from dietary, inhalation, or
dermal exposure to these polymers.
IV. Aggregate Exposures
For the purposes of assessing
potential exposure under this
exemption, EPA considered that these
polymers could be present in all raw
and processed agricultural commodities
and drinking water, and that nonoccupational non-dietary exposure was
possible. The minimum number average
molecular weight of each of these
polymers is 1,100 Daltons. Generally,
polymers of this size would be poorly
absorbed through the intact
gastrointestinal tract or through intact
human skin. Since these polymers
conform to the criteria that identify a
low-risk polymer, there are no concerns
for risks associated with any potential
exposure scenarios that are reasonably
foreseeable. The Agency has determined
that a tolerance is not necessary to
protect the public health.
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V. Cumulative Effects From Substances
With a Common Mechanism of Toxicity
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found that these
polymers to share a common
mechanism of toxicity with any other
substances, and these polymers does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that these
polymers do not have a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s Web site at https://
www.epa.gov/pesticides/cumulative.
VI. Additional Safety Factor for the
Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA
provides that EPA shall apply an
additional tenfold margin of safety for
infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the data base unless
EPA concludes that a different margin of
safety will be safe for infants and
children. Due to the expected low
toxicity of these polymers, EPA has not
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used a safety factor analysis to assess
the risk. For the same reasons the
additional tenfold safety factor is
unnecessary.
VII. Determination of Safety
Based on the conformance to the
criteria used to identify a low-risk
polymer, EPA concludes that there is a
reasonable certainty of no harm to the
U.S. population, including infants and
children, from aggregate exposure to
residues of D-glucitol, polymer with
decanedioic acid, octadecanoate; Dglucitol, polymer with decanedioic acid,
docosanoate; D-glucitol, polymer with
decanedioic acid, docosanoate; Dglucitol, polymer with decanedioic acid
and 1,3-propanediol, docosanoate; Dglucitol, polymer with decanedioic acid
and 1,3-propanediol, octadecanoate;
fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid and
sorbitol; fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid, 1,3propanediol and stearic acid; fatty acids,
C18-unsatd., dimers, polymers with
sorbitol and stearic acid; fatty acids, C18unsatd., dimers, polymers with 1,3propanediol, sorbitol and stearic acid;
fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid and
sorbitol; and fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid,
1,3-propanediol and sorbitol.
VIII. Other Considerations
A. Existing Exemptions From a
Tolerance
There are no existing tolerance
exemptions for this polymer.
B. 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.
C. 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
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different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for D-glucitol, polymer with
decanedioic acid, octadecanoate; Dglucitol, polymer with decanedioic acid,
docosanoate; D-glucitol, polymer with
decanedioic acid, docosanoate; Dglucitol, polymer with decanedioic acid
and 1,3-propanediol, docosanoate; Dglucitol, polymer with decanedioic acid
and 1,3-propanediol, octadecanoate;
fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid and
sorbitol; fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid, 1,3propanediol and stearic acid; fatty acids,
C18-unsatd., dimers, polymers with
sorbitol and stearic acid; fatty acids, C18unsatd., dimers, polymers with 1,3propanediol, sorbitol and stearic acid;
fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid and
sorbitol; and fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid,
1,3-propanediol and sorbitol.
IX. Conclusion
Accordingly, EPA finds that
exempting residues of D-glucitol,
polymer with decanedioic acid,
octadecanoate; D-glucitol, polymer with
decanedioic acid, docosanoate; Dglucitol, polymer with decanedioic acid,
docosanoate; D-glucitol, polymer with
decanedioic acid and 1,3-propanediol,
docosanoate; D-glucitol, polymer with
decanedioic acid and 1,3-propanediol,
octadecanoate; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid
and sorbitol; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid,
1,3-propanediol and stearic acid; fatty
acids, C18-unsatd., dimers, polymers
with sorbitol and stearic acid; fatty
acids, C18-unsatd., dimers, polymers
with 1,3-propanediol, sorbitol and
stearic acid; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid
and sorbitol; and fatty acids, C18unsatd., dimers, polymers with
docosanoic acid, 1,3-propanediol and
sorbitol from the requirement of a
tolerance will be safe.
X. Statutory and Executive Order
Reviews
This action 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 action
has been exempted from review under
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Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action 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 action 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 action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
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
(NTTAA) (15 U.S.C. 272 note).
XI. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: November 23, 2015.
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 § 180.960, add alphabetically the
polymers to the table to read as follows:
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
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Polymer
CAS No.
*
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*
D-Glucitol, polymer with decanedioic acid, docosanoate, minimum number average molecular weight (in amu) 1,100 ..............
D-Glucitol, polymer with decanedioic acid, docosanoate, minimum number average molecular weight (in amu) 1,100 ..............
D-Glucitol, polymer with decanedioic acid, octadecanoate, minimum number average molecular weight (in amu) 1,100 ...........
D-Glucitol, polymer with decanedioic acid and 1,3-propanediol, minimum number average molecular weight (in amu) 1,100 ....
D-Glucitol, polymer with decanedioic acid and 1,3-propanediol, octadecanoate, minimum number average molecular weight
(in amu) 1,100 ..............................................................................................................................................................................
*
*
*
*
*
*
Fatty acids, C18-unsatd., dimers, polymers with docosanoic acid and sorbitol, minimum number average molecular weight (in
amu) 1,100 ...................................................................................................................................................................................
Fatty acids, C18-unsatd., dimers, polymers with docosenoic acid and sorbitol, minimum number average molecular weight (in
amu) 1,100 ...................................................................................................................................................................................
Fatty acids, C18-unsatd., dimers, polymers with docosenoic acid, 1,3-propanediol and sorbitol, minimum number average molecular weight (in amu) 1,100 ......................................................................................................................................................
Fatty acids, C18-unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and stearic acid, minimum number average
molecular weight (in amu) 1,100 .................................................................................................................................................
Fatty acids, C18-unsatd., dimers, polymers with 1,3-propanediol, sorbitol and stearic acid ...........................................................
Fatty acids, C18-unsatd., dimers, polymers with sorbitol and stearic acid, minimum number average molecular weight (in amu)
1,100 ............................................................................................................................................................................................
Lhorne on DSK5TPTVN1PROD with RULES
*
*
*
*
*
*
[FR Doc. 2015–30510 Filed 12–9–15; 8:45 am]
BILLING CODE 6560–50–P
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1681043–28–6
68562–93–6
1681043–31–1
1681043–33–3
*
1685270–83–0
1685271–02–6
1685271–04–8
1685270–84–1
1685271–01–5
1685270–99–8
*
76644
Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Rules and Regulations
and Mitigation Administration, Federal
Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,
(202) 646–4064, or (email)
Luis.Rodriguez3@fema.dhs.gov.
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
The
Federal Emergency Management Agency
(FEMA) makes the final determinations
listed below for the modified BFEs for
each community listed. These modified
elevations have been published in
newspapers of local circulation and
ninety (90) days have elapsed since that
publication. The Deputy Associate
Administrator for Mitigation has
resolved any appeals resulting from this
notification.
This final rule is issued in accordance
with section 110 of the Flood Disaster
Protection Act of 1973, 42 U.S.C. 4104,
and 44 CFR part 67. FEMA has
developed criteria for floodplain
management in floodprone areas in
accordance with 44 CFR part 60.
Interested lessees and owners of real
property are encouraged to review the
proof Flood Insurance Study and FIRM
available at the address cited below for
each community. The BFEs and
modified BFEs are made final in the
communities listed below. Elevations at
selected locations in each community
are shown.
National Environmental Policy Act.
This final rule is categorically excluded
from the requirements of 44 CFR part
10, Environmental Consideration. An
environmental impact assessment has
not been prepared.
Regulatory Flexibility Act. As flood
elevation determinations are not within
the scope of the Regulatory Flexibility
SUPPLEMENTARY INFORMATION:
44 CFR Part 67
[Docket ID FEMA–2015–0001]
Final Flood Elevation Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
Base (1% annual-chance)
Flood Elevations (BFEs) and modified
BFEs are made final for the
communities listed below. The BFEs
and modified BFEs are the basis for the
floodplain management measures that
each community is required either to
adopt or to show evidence of being
already in effect in order to qualify or
remain qualified for participation in the
National Flood Insurance Program
(NFIP).
DATES: The date of issuance of the Flood
Insurance Rate Map (FIRM) showing
BFEs and modified BFEs for each
community. This date may be obtained
by contacting the office where the maps
are available for inspection as indicated
in the table below.
ADDRESSES: The final BFEs for each
community are available for inspection
at the office of the Chief Executive
Officer of each community. The
respective addresses are listed in the
table below.
FOR FURTHER INFORMATION CONTACT: Luis
Rodriguez, Chief, Engineering
Management Branch, Federal Insurance
SUMMARY:
Flooding source(s)
Act, 5 U.S.C. 601–612, a regulatory
flexibility analysis is not required.
Regulatory Classification. This final
rule is not a significant regulatory action
under the criteria of section 3(f) of
Executive Order 12866 of September 30,
1993, Regulatory Planning and Review,
58 FR 51735.
Executive Order 13132, Federalism.
This final rule involves no policies that
have federalism implications under
Executive Order 13132.
Executive Order 12988, Civil Justice
Reform. This final rule meets the
applicable standards of Executive Order
12988.
List of Subjects in 44 CFR Part 67
Administrative practice and
procedure, Flood insurance, Reporting
and recordkeeping requirements.
Dated: November 18, 2015.
Roy E. Wright,
Deputy Associate Administrator for Insurance
and Mitigation, Department of Homeland
Security, Federal Emergency Management
Agency.
Accordingly, 44 CFR part 67 is
amended as follows:
PART 67—[AMENDED]
1. The authority citation for part 67
continues to read as follows:
■
Authority: 42 U.S.C. 4001 et seq.;
Reorganization Plan No. 3 of 1978, 3 CFR,
1978 Comp., p. 329; E.O. 12127, 44 FR 19367,
3 CFR, 1979 Comp., p. 376.
§ 67.11
[Amended]
2. The tables published under the
authority of § 67.11 are amended as
follows:
■
* Elevation in feet
(NGVD)
+ Elevation in feet
(NAVD)
# Depth in feet
above ground
∧ Elevation in
meters (MSL)
Modified
Location of referenced elevation
Communities
affected
Montgomery County, Pennsylvania (All Jurisdictions)
Docket No.: FEMA–B–1175
At the Pennypack Creek confluence ...................................
+211
Blair Mill Run Tributary .............
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Blair Mill Run ............................
Huntingdon Valley Creek ..........
At the downstream side of County Line Road ....................
At the upstream side of West Monument Avenue ..............
At the downstream side of East County Line Road ...........
Approximately 800 feet downstream of Red Lion Road .....
+261
+228
+252
+120
Meadow Brook ..........................
Approximately 0.9 mile upstream of Byberry Road ............
At the Pennypack Creek confluence ...................................
+267
+118
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Borough of Hatboro, Township of Horsham, Township of Upper Moreland.
Borough of Hatboro.
Borough of Bryn Athyn,
Township of Lower
Moreland.
Township of Abington, Township of Lower Moreland.
]]>Agencies
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Rules and Regulations]
[Pages 76640-76644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30510]
[[Page 76640]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0465; FRL-9936-91]
Polyester Polyol Polymers; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of D-glucitol, polymer with decanedioic
acid, octadecanoate; D-glucitol, polymer with decanedioic acid,
docosanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D-
glucitol, polymer with decanedioic acid and 1,3-propanediol,
docosanoate; D-glucitol, polymer with decanedioic acid and 1,3-
propanediol, octadecanoate; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid and sorbitol; fatty acids,
C18-unsatd., dimers, polymers with docosanoic acid, 1,3-
propanediol and stearic acid; fatty acids, C18-unsatd.,
dimers, polymers with sorbitol and stearic acid; fatty acids,
C18-unsatd., dimers, polymers with 1,3-propanediol, sorbitol
and stearic acid; fatty acids, C18-unsatd., dimers, polymers
with docosanoic acid and sorbitol; and fatty acids, C18-
unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and
sorbitol when used as inert ingredients in a pesticide chemical
formulation. Spring Trading Co., on behalf of Croda Inc., submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of D-glucitol, polymer with decanedioic acid,
octadecanoate; D-glucitol, polymer with decanedioic acid, docosanoate;
D-glucitol, polymer with decanedioic acid, docosanoate; D-glucitol,
polymer with decanedioic acid and 1,3-propanediol, docosanoate; D-
glucitol, polymer with decanedioic acid and 1,3-propanediol,
octadecanoate; fatty acids, C18-unsatd., dimers, polymers
with docosanoic acid and sorbitol; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid, 1,3-propanediol and stearic
acid; fatty acids, C18-unsatd., dimers, polymers with
sorbitol and stearic acid; fatty acids, C18-unsatd., dimers,
polymers with 1,3-propanediol, sorbitol and stearic acid; fatty acids,
C18-unsatd., dimers, polymers with docosanoic acid and
sorbitol; and fatty acids, C18-unsatd., dimers, polymers
with docosanoic acid, 1,3-propanediol and sorbitol on food or feed
commodities.
DATES: This regulation is effective December 10, 2015. Objections and
requests for hearings must be received on or before February 8, 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-2015-0465, 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. 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-2015-0465 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
February 8, 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-2015-0465, 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. Background and Statutory Findings
In the Federal Register of August 26, 2015 (80 FR 51763) (FRL-9931-
74), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP IN-10830)
filed by Spring Trading Company, 203 Dogwood Trl., Magnolia, TX 77354
(on behalf of Croda,
[[Page 76641]]
Inc., 315 Cherry Ln., New Castle, DE 19720). The petition requested
that 40 CFR 180.960 be amended by establishing an exemption from the
requirement of a tolerance for residues of D-glucitol, polymer with
decanedioic acid, octadecanoate (CAS Reg. No. 68562-93-6); D-glucitol,
polymer with decanedioic acid, docosanoate (CAS Reg. No. 943440-33-3);
D-glucitol, polymer with decanedioic acid, docosanoate (CAS Reg. No.
1681043-28-6); D-glucitol, polymer with decanedioic acid and 1,3-
propanediol, docosanoate (CAS Reg. No. 1681043-31-1); D-glucitol,
polymer with decanedioic acid and 1,3-propanediol, octadecanoate (CAS
Reg. No. 1681043-33-3); fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid and sorbitol (CAS Reg. No. 1685270-83-0);
fatty acids, C18-unsatd., dimers, polymers with docosanoic
acid, 1,3-propanediol and stearic acid (CAS Reg. No. 1685270-84-1);
fatty acids, C18-unsatd., dimers, polymers with sorbitol and
stearic acid (CAS Reg. No. 1685270-99-8); fatty acids, C18-
unsatd., dimers, polymers with 1,3-propanediol, sorbitol and stearic
acid (CAS Reg, No. 1685271-01-5); fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid and sorbitol (CAS Reg. No.
1685271-02-6); and fatty acids, C18-unsatd., dimers,
polymers with docosanoic acid, 1,3-propanediol and sorbitol. That
document included a summary of the petition prepared by the petitioner
and solicited comments on the petitioner's request. No comments were
received by the Agency in response to the notice of filing. 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 exemption is
``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines ``safe'' to mean
that ``there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue, including all
anticipated dietary exposures and all other exposures for which there
is reliable information.'' This includes exposure through drinking
water and use 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 an exemption from the
requirement of 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 . . .'' and
specifies factors EPA is to consider in establishing an exemption.
III. Risk Assessment and Statutory Findings
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown 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(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d).
D-Glucitol, polymer with decanedioic acid, octadecanoate; D-
glucitol, polymer with decanedioic acid, docosanoate; D-glucitol,
polymer with decanedioic acid, docosanoate; D-glucitol, polymer with
decanedioic acid and 1,3-propanediol, docosanoate; D-glucitol, polymer
with decanedioic acid and 1,3-propanediol, octadecanoate; fatty acids,
C18-unsatd., dimers, polymers with docosanoic acid and
sorbitol; fatty acids, C18-unsatd., dimers, polymers with
docosanoic acid, 1,3-propanediol and stearic acid; fatty acids,
C18-unsatd., dimers, polymers with sorbitol and stearic
acid; fatty acids, C18-unsatd., dimers, polymers with 1,3-
propanediol, sorbitol and stearic acid; fatty acids, C18-
unsatd., dimers, polymers with docosanoic acid and sorbitol; and fatty
acids, C18-unsatd., dimers, polymers with docosanoic acid,
1,3-propanediol and sorbitol conform to the definition of a polymer
given in 40 CFR 723.250(b) and meet the following criteria that are
used to identify low-risk polymers.
1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
2. The polymer does contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 Daltons.
Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
7. The polymer's minimum number average molecular weight is greater
1,000 Daltons. The oligomer content is less than 10% (w/w) below a
number average molecular weight of 500 and less than 25% (w/w) below a
number average molecular weight of 1,000.
Thus, D-glucitol, polymer with decanedioic acid, octadecanoate; D-
glucitol, polymer with decanedioic acid, docosanoate; D-glucitol,
polymer with decanedioic acid, docosanoate; D-glucitol, polymer with
decanedioic acid and 1,3-propanediol, docosanoate; D-glucitol, polymer
with decanedioic acid and 1,3-propanediol, octadecanoate; fatty acids,
C18-unsatd., dimers, polymers with docosanoic acid and
sorbitol; fatty acids, C18-unsatd., dimers, polymers with
docosanoic acid, 1,3-propanediol and stearic acid; fatty acids,
C18-unsatd., dimers, polymers with sorbitol and stearic
acid; fatty acids, C18-unsatd., dimers, polymers with 1,3-
propanediol, sorbitol and stearic acid; fatty acids, C18-
unsatd., dimers, polymers with docosanoic acid and sorbitol; and fatty
acids, C18-unsatd., dimers, polymers with docosanoic acid,
1,3-propanediol and sorbitol meet the criteria for a polymer to be
considered low risk under 40 CFR 723.250. Based on their conformance to
the criteria in
[[Page 76642]]
this unit, no mammalian toxicity is anticipated from dietary,
inhalation, or dermal exposure to these polymers.
IV. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that these polymers could be present in all
raw and processed agricultural commodities and drinking water, and that
non-occupational non-dietary exposure was possible. The minimum number
average molecular weight of each of these polymers is 1,100 Daltons.
Generally, polymers of this size would be poorly absorbed through the
intact gastrointestinal tract or through intact human skin. Since these
polymers conform to the criteria that identify a low-risk polymer,
there are no concerns for risks associated with any potential exposure
scenarios that are reasonably foreseeable. The Agency has determined
that a tolerance is not necessary to protect the public health.
V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA has not found that these polymers to share a common mechanism
of toxicity with any other substances, and these polymers does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
these polymers do not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticides/cumulative.
VI. Additional Safety Factor for the Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of these polymers, EPA has
not used a safety factor analysis to assess the risk. For the same
reasons the additional tenfold safety factor is unnecessary.
VII. Determination of Safety
Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of D-glucitol, polymer with decanedioic
acid, octadecanoate; D-glucitol, polymer with decanedioic acid,
docosanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D-
glucitol, polymer with decanedioic acid and 1,3-propanediol,
docosanoate; D-glucitol, polymer with decanedioic acid and 1,3-
propanediol, octadecanoate; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid and sorbitol; fatty acids,
C18-unsatd., dimers, polymers with docosanoic acid, 1,3-
propanediol and stearic acid; fatty acids, C18-unsatd.,
dimers, polymers with sorbitol and stearic acid; fatty acids,
C18-unsatd., dimers, polymers with 1,3-propanediol, sorbitol
and stearic acid; fatty acids, C18-unsatd., dimers, polymers
with docosanoic acid and sorbitol; and fatty acids, C18-
unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and
sorbitol.
VIII. Other Considerations
A. Existing Exemptions From a Tolerance
There are no existing tolerance exemptions for this polymer.
B. 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.
C. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for D-glucitol, polymer with
decanedioic acid, octadecanoate; D-glucitol, polymer with decanedioic
acid, docosanoate; D-glucitol, polymer with decanedioic acid,
docosanoate; D-glucitol, polymer with decanedioic acid and 1,3-
propanediol, docosanoate; D-glucitol, polymer with decanedioic acid and
1,3-propanediol, octadecanoate; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid and sorbitol; fatty acids,
C18-unsatd., dimers, polymers with docosanoic acid, 1,3-
propanediol and stearic acid; fatty acids, C18-unsatd.,
dimers, polymers with sorbitol and stearic acid; fatty acids,
C18-unsatd., dimers, polymers with 1,3-propanediol, sorbitol
and stearic acid; fatty acids, C18-unsatd., dimers, polymers
with docosanoic acid and sorbitol; and fatty acids, C18-
unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and
sorbitol.
IX. Conclusion
Accordingly, EPA finds that exempting residues of D-glucitol,
polymer with decanedioic acid, octadecanoate; D-glucitol, polymer with
decanedioic acid, docosanoate; D-glucitol, polymer with decanedioic
acid, docosanoate; D-glucitol, polymer with decanedioic acid and 1,3-
propanediol, docosanoate; D-glucitol, polymer with decanedioic acid and
1,3-propanediol, octadecanoate; fatty acids, C18-unsatd.,
dimers, polymers with docosanoic acid and sorbitol; fatty acids,
C18-unsatd., dimers, polymers with docosanoic acid, 1,3-
propanediol and stearic acid; fatty acids, C18-unsatd.,
dimers, polymers with sorbitol and stearic acid; fatty acids,
C18-unsatd., dimers, polymers with 1,3-propanediol, sorbitol
and stearic acid; fatty acids, C18-unsatd., dimers, polymers
with docosanoic acid and sorbitol; and fatty acids, C18-
unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and
sorbitol from the requirement of a tolerance will be safe.
X. Statutory and Executive Order Reviews
This action 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 action has been
exempted from review under
[[Page 76643]]
Executive Order 12866, this action is not subject to Executive Order
13211, entitled ``Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22,
2001) or Executive Order 13045, entitled ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997). This action 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
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 (NTTAA) (15 U.S.C. 272 note).
XI. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 23, 2015.
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. 180.960, add alphabetically the polymers to the table to
read as follows:
Sec. 180.960 Polymers; exemptions from the requirement of a
tolerance.
* * * * *
------------------------------------------------------------------------
Polymer CAS No.
------------------------------------------------------------------------
* * * * * * *
D-Glucitol, polymer with decanedioic acid, 943440-33-3
docosanoate, minimum number average molecular weight
(in amu) 1,100.......................................
D-Glucitol, polymer with decanedioic acid, 1681043-28-6
docosanoate, minimum number average molecular weight
(in amu) 1,100.......................................
D-Glucitol, polymer with decanedioic acid, 68562-93-6
octadecanoate, minimum number average molecular
weight (in amu) 1,100................................
D-Glucitol, polymer with decanedioic acid and 1,3- 1681043-31-1
propanediol, minimum number average molecular weight
(in amu) 1,100.......................................
D-Glucitol, polymer with decanedioic acid and 1,3- 1681043-33-3
propanediol, octadecanoate, minimum number average
molecular weight (in amu) 1,100......................
* * * * * * *
Fatty acids, C18-unsatd., dimers, polymers with 1685270-83-0
docosanoic acid and sorbitol, minimum number average
molecular weight (in amu) 1,100......................
Fatty acids, C18-unsatd., dimers, polymers with 1685271-02-6
docosenoic acid and sorbitol, minimum number average
molecular weight (in amu) 1,100......................
Fatty acids, C18-unsatd., dimers, polymers with 1685271-04-8
docosenoic acid, 1,3-propanediol and sorbitol,
minimum number average molecular weight (in amu)
1,100................................................
Fatty acids, C18-unsatd., dimers, polymers with 1685270-84-1
docosanoic acid, 1,3-propanediol and stearic acid,
minimum number average molecular weight (in amu)
1,100................................................
Fatty acids, C18-unsatd., dimers, polymers with 1,3- 1685271-01-5
propanediol, sorbitol and stearic acid...............
Fatty acids, C18-unsatd., dimers, polymers with 1685270-99-8
sorbitol and stearic acid, minimum number average
molecular weight (in amu) 1,100......................
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2015-30510 Filed 12-9-15; 8:45 am]
BILLING CODE 6560-50-P
