Polymers; exemptions from the requirement of a tolerance., 65831-65834 [2012-26521]
Download as PDF
<-2-[[[[1-[3
(trifluoromethyl)phenyl]ethylidene]
amino] oxy]methyl]-methyl ester), in or
on almond, hulls from 3.0 ppm to 9.0
ppm. EPA is also granting the
petitioner’s request to remove the
tolerance for Vegetable, root, except
sugar beet, subgroup 1B, except radish.
This tolerance should have been
removed by EPA in its January 2, 2008
rulemaking, (73 FR 52) (FRL–8342–6),
that added a tolerance for ‘‘Vegetable,
root, except sugar beet, subgroup 1B.’’
The ‘‘Vegetable, root, except sugar beet,
subgroup 1B’’ tolerance was intended as
a replacement for the tolerance
‘‘Vegetable, root, except sugar beet,
subgroup 1B, except radish.’’ EPA is
correcting that error in this action.
Finally, the specific tolerance is
removed for almonds because this
commodity is covered by crop group
tolerances.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This final rule does not
contain any information collections
VerDate Mar<15>2010
16:49 Oct 30, 2012
Jkt 229001
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
PO 00000
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Fmt 4700
Sfmt 4700
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: October 15, 2012.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.555, in the table in
paragraph (a), remove the entries for
‘‘Almond’’ and ‘‘Vegetable, root, except
sugar beet, subgroup 1B, except radish’’
and revise the entry for ‘‘Almond,
hulls’’ to read as follows:
■
§ 180.555 Trifloxystrobin; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
*
*
*
*
Almond, hulls ............................
*
*
*
*
*
*
*
*
9.0
*
*
[FR Doc. 2012–26757 Filed 10–30–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0279; FRL–9365–3]
A-(R-Nonylphenyl)poly(oxypropylene)
Block Polymer With Poly(oxyethylene);
Tolerance Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation amends an
exemption from the requirement of a
tolerance for residues of a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene); when
used as an inert ingredient in a pesticide
chemical formulation. Stephan
Company 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
SUMMARY:
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Federal Register / Vol. 77, No. 211 / Wednesday, October 31, 2012 / Rules and Regulations
need to establish a maximum
permissible level for residues of a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene) on food
or feed commodities.
DATES: This regulation is effective
October 31, 2012. Objections and
requests for hearings must be received
on or before December 31, 2012, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2012–0279, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
William Cutchin, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7099; email address:
cutchin.william@epa.gov.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with RULES
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
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Jkt 229001
through the Government Printing
Office’s e-CFR site at https://
ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. 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–2012–0279 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before December 31, 2012. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any CBI) for inclusion in the public
docket. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit the nonCBI copy of your objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2012–0279, by one of
the following methods.
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Background and Statutory Findings
In the Federal Register of July 25,
2012 (77 FR 43562) (FRL–9353–6), EPA
issued a notice pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the receipt of a pesticide petition (PP
PO 00000
Frm 00060
Fmt 4700
Sfmt 4700
2E8000) filed by Stephan Company, 22
West Frontage Rd., Northfield Illinois
60093. The petition requested that 40
CFR 180.960 be amended by revising an
exemption from the requirement of a
tolerance for residues of a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene); CAS
No. 37251–69–7. That notice included a
summary of the petition prepared by the
petitioner and solicited comments on
the petitioner’s request. The Agency did
not receive any comments.
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.
E:\FR\FM\31OCR1.SGM
31OCR1
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Federal Register / Vol. 77, No. 211 / Wednesday, October 31, 2012 / Rules and Regulations
Consistent with FFDCA section
408(b)(2)(D), EPA has reviewed the
available scientific data and other
relevant information in support of this
final rule 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). a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene)
conforms to the definition of a polymer
given in 40 CFR 723.250(b) and meets
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 number average MW
of 1,889 is greater than 1,000 and less
than 10,000 daltons. The polymer
contains less than 10 percent oligomeric
material below MW 500 and less than
25 percent oligomeric material below
MW 1,000, and the polymer does not
contain any reactive functional groups.
Thus, a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene) meets
the criteria for a polymer to be
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Jkt 229001
considered low risk under 40 CFR
723.250. Based on its conformance to
the criteria in 40 CFR 723.250, no
mammalian toxicity is anticipated from
dietary, inhalation, or dermal exposure
to a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene).
IV. Aggregate Exposures
For the purposes of assessing
potential exposure under this
exemption, EPA considered that a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene) could
be present in all raw and processed
agricultural commodities and drinking
water, and that non-occupational nondietary exposure was possible. The
number average MW of a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene) is 1,889
daltons. Generally, a polymer of this
size would be poorly absorbed through
the intact gastrointestinal tract or
through intact human skin. Since a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene)
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 a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene) to
share a common mechanism of toxicity
with any other substances, and a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene) does
not appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene) does
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.
PO 00000
Frm 00061
Fmt 4700
Sfmt 4700
65833
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 a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene), 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 a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene).
VIII. Other Considerations
A. Existing Exemptions From a
Tolerance
There is an existing tolerance for a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene); poly
oxyethylene content 30 to 90 moles;
molecular weight (in amu) averages
3,000 in 40 CFR 180.960.
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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Federal Register / Vol. 77, No. 211 / Wednesday, October 31, 2012 / Rules and Regulations
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 a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene).
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IX. Conclusion
Accordingly, EPA finds that
exempting residues of a-(rNonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene) from
the requirement of a tolerance will be
safe.
X. Statutory and Executive Order
Reviews
This final rule establishes an
exemption from the requirement of a
tolerance under FFDCA section 408(d)
in response to a petition submitted to
the Agency. The Office of Management
and Budget (OMB) has exempted these
rules 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 involve
any technical standards that would
require Agency consideration of
voluntary consensus standards pursuant
to section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272
note).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
VerDate Mar<15>2010
16:49 Oct 30, 2012
Jkt 229001
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, or otherwise have any unique
impacts on local governments. Thus, the
Agency has determined that Executive
Order 13132, entitled ‘‘Federalism’’ (64
FR 43255, August 10, 1999) and
Executive Order 13175, entitled
‘‘Consultation and Coordination with
Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
Although this action does not 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), EPA seeks to achieve
environmental justice, the fair treatment
and meaningful involvement of any
group, including minority and/or lowincome populations, in the
development, implementation, and
enforcement of environmental laws,
regulations, and policies. As such, to the
extent that information is publicly
available or was submitted in comments
to EPA, the Agency considered whether
groups or segments of the population, as
a result of their location, cultural
practices, or other factors, may have
atypical or disproportionately high and
adverse human health impacts or
environmental effects from exposure to
the pesticide discussed in this
document, compared to the general
population.
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.
PO 00000
Frm 00062
Fmt 4700
Sfmt 4700
Dated: October 15, 2012.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In the table to § 180.960, revise the
following polymer entry which appears
immediately above the polymer entry
which reads in part ‘‘Octadecanoic acid,
12-hydroxy-* * *’’, with ‘‘CAS No.
58128–22–6,’’ to read as follows:
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
*
*
*
*
Polymer
CAS No.
*
*
*
a-(r-Nonylphenyl)poly
(oxypropylene) block polymer with poly(oxyethylene); poly oxyethylene
content 30 to 90 moles;
minimum number average
molecular weight (in amu),
1,889 .................................
*
*
*
*
*
*
*
*
*
37251–69–7
*
*
*
[FR Doc. 2012–26521 Filed 10–30–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0278; FRL–9365–4]
Residues of Fatty Acids, Tall-Oil,
Ethoxylated Propoxylated; Tolerance
Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of fatty acids, talloil, ethoxylated propoxylated; when
used as an inert ingredient in a pesticide
chemical formulation. Stephan
Company 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 fatty
SUMMARY:
E:\FR\FM\31OCR1.SGM
31OCR1
]]>Agencies
[Federal Register Volume 77, Number 211 (Wednesday, October 31, 2012)]
[Rules and Regulations]
[Pages 65831-65834]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-26521]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0279; FRL-9365-3]
[Alpha]-([Rho]-Nonylphenyl)poly(oxypropylene) Block Polymer With
Poly(oxyethylene); Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends an exemption from the requirement of a
tolerance for residues of [alpha]-([rho]-Nonylphenyl)poly(oxypropylene)
block polymer with poly(oxyethylene); when used as an inert ingredient
in a pesticide chemical formulation. Stephan Company 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
[[Page 65832]]
need to establish a maximum permissible level for residues of [alpha]-
([rho]-Nonylphenyl)poly(oxypropylene) block polymer with
poly(oxyethylene) on food or feed commodities.
DATES: This regulation is effective October 31, 2012. Objections and
requests for hearings must be received on or before December 31, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0279, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: William Cutchin, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7099; email address: cutchin.william@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. 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-2012-0279 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
December 31, 2012. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any CBI) for inclusion in the public docket.
Information not marked confidential pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior notice. Submit the non-CBI copy
of your objection or hearing request, identified by docket ID number
EPA-HQ-OPP-2012-0279, by one of the following methods.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.htm. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-
6), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a,
announcing the receipt of a pesticide petition (PP 2E8000) filed by
Stephan Company, 22 West Frontage Rd., Northfield Illinois 60093. The
petition requested that 40 CFR 180.960 be amended by revising an
exemption from the requirement of a tolerance for residues of [alpha]-
([rho]-Nonylphenyl)poly(oxypropylene) block polymer with
poly(oxyethylene); CAS No. 37251-69-7. That notice included a summary
of the petition prepared by the petitioner and solicited comments on
the petitioner's request. The Agency did not receive any comments.
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.
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Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this final rule 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). [alpha]-([rho]-
Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene)
conforms to the definition of a polymer given in 40 CFR 723.250(b) and
meets 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 number average MW of 1,889 is greater than 1,000
and less than 10,000 daltons. The polymer contains less than 10 percent
oligomeric material below MW 500 and less than 25 percent oligomeric
material below MW 1,000, and the polymer does not contain any reactive
functional groups.
Thus, [alpha]-([rho]-Nonylphenyl)poly(oxypropylene) block polymer
with poly(oxyethylene) meets the criteria for a polymer to be
considered low risk under 40 CFR 723.250. Based on its conformance to
the criteria in 40 CFR 723.250, no mammalian toxicity is anticipated
from dietary, inhalation, or dermal exposure to [alpha]-([rho]-
Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene).
IV. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that [alpha]-([rho]-
Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene)
could be present in all raw and processed agricultural commodities and
drinking water, and that non-occupational non-dietary exposure was
possible. The number average MW of [alpha]-([rho]-
Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene) is
1,889 daltons. Generally, a polymer of this size would be poorly
absorbed through the intact gastrointestinal tract or through intact
human skin. Since [alpha]-([rho]-Nonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene) 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 [alpha]-([rho]-Nonylphenyl)poly(oxypropylene)
block polymer with poly(oxyethylene) to share a common mechanism of
toxicity with any other substances, and [alpha]-([rho]-
Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene)
does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that [alpha]-([rho]-Nonylphenyl)poly(oxypropylene) block
polymer with poly(oxyethylene) does 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 [alpha]-([rho]-
Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene),
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 [alpha]-([rho]-
Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene).
VIII. Other Considerations
A. Existing Exemptions From a Tolerance
There is an existing tolerance for [alpha]-([rho]-
Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene);
poly oxyethylene content 30 to 90 moles; molecular weight (in amu)
averages 3,000 in 40 CFR 180.960.
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
[[Page 65834]]
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 [alpha]-([rho]-
Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene).
IX. Conclusion
Accordingly, EPA finds that exempting residues of [alpha]-([rho]-
Nonylphenyl)poly(oxypropylene) block polymer with poly(oxyethylene)
from the requirement of a tolerance will be safe.
X. Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these rules 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 involve any technical standards that
would require Agency consideration of voluntary consensus standards
pursuant to section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes, or otherwise have any unique
impacts on local governments. Thus, the Agency has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999) and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000) do not apply to this final rule. In addition, this final rule
does not impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
Although this action does not 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), EPA seeks to achieve
environmental justice, the fair treatment and meaningful involvement of
any group, including minority and/or low-income populations, in the
development, implementation, and enforcement of environmental laws,
regulations, and policies. As such, to the extent that information is
publicly available or was submitted in comments to EPA, the Agency
considered whether groups or segments of the population, as a result of
their location, cultural practices, or other factors, may have atypical
or disproportionately high and adverse human health impacts or
environmental effects from exposure to the pesticide discussed in this
document, compared to the general population.
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: October 15, 2012.
Lois Rossi,
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 the table to Sec. 180.960, revise the following polymer entry
which appears immediately above the polymer entry which reads in part
``Octadecanoic acid, 12-hydroxy-* * *'', with ``CAS No. 58128-22-6,''
to read as follows:
Sec. [emsp14]180.960 Polymers; exemptions from the requirement of a
tolerance.
* * * * *
------------------------------------------------------------------------
Polymer CAS No.
------------------------------------------------------------------------
* * * * *
[alpha]-([rho]-Nonylphenyl)poly(oxypropylene) block 37251-69-7
polymer with poly(oxyethylene); poly oxyethylene
content 30 to 90 moles; minimum number average
molecular weight (in amu), 1,889.......................
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-26521 Filed 10-30-12; 8:45 am]
BILLING CODE 6560-50-P
