[alpha]-(p-Nonylphenol)-[omega]-hydroxypoly(oxyethylene) Sulfate and Phosphate Esters; Exemption From the Requirement of a Tolerance, 27126-27130 [2012-10933]
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2011–0526; FRL–9340–2]
α-(p-Nonylphenol)-whydroxypoly(oxyethylene) Sulfate and
Phosphate Esters; Exemption From
the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of a-(pnonylphenol)-whydroxypoly(oxyethylene) mixture of
dihydrogen phosphate and
monohydrogen phosphate esters and the
corresponding ammonium, calcium,
magnesium, potassium, sodium, and
zinc salts of the phosphate esters and a(p-nonylphenol)-whydroxypoly(oxyethylene) sulfate,
ammonium, calcium, magnesium,
potassium, sodium, and zinc salts when
used as inert ingredients at levels not to
exceed 7% in pesticide formulations
applied to growing crops, raw
agricultural commodities after harvest
and animals. The Joint Inerts Task
Force, (JITF) Cluster Support Team
Number (CST) 9 submitted a petition to
EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting
SUMMARY:
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establishment of an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of a-(p-nonylphenol)-whydroxypoly(oxyethylene) mixture of
dihydrogen phosphate and
monohydrogen phosphate esters and the
corresponding ammonium, calcium,
magnesium, potassium, sodium, and
zinc salts of the phosphate esters and a(p-nonylphenol)-whydroxypoly(oxyethylene) sulfate,
ammonium, calcium, magnesium,
potassium, sodium, and zinc salts.
DATES: This regulation is effective May
9, 2012. Objections and requests for
hearings must be received on or before
July 9, 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).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2011–0526. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8811; email address:
leifer.kerry@epa.gov.
ADDRESSES:
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. Potentially
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Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
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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. To access the OCSPP test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2011–0526 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 July 9, 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 that does not
contain 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 a copy of
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15:36 May 08, 2012
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your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2011–0526, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Background
In the Federal Register of August 26,
2011 (76 FR 53372) (FRL–8884–9), EPA
issued a notice pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (PP
1E7860) by Joint Inerts Task Force,
Cluster Support Team 9, c/o CropLife
America, 1156 15th St. NW., Suite 400,
Washington, DC 20005. The petition
requested that 40 CFR 180.910 and 40
CFR 180.930 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of a-(p-nonylphenol)-whydroxypoly(oxyethylene) mixture of
dihydrogen phosphate and
monohydrogen phosphate esters and the
corresponding ammonium, calcium,
magnesium, potassium, sodium, and
zinc salts of the phosphate esters and a(p-nonylphenol)-whydroxypoly(oxyethylene) sulfate,
ammonium, calcium, magnesium,
potassium, sodium, and zinc salts when
used as inert ingredients at levels not to
exceed 7% in pesticide formulations
applied to growing crops and raw
agricultural commodities after harvest
and to animals. That notice referenced
a summary of the petition prepared by
JITF, CST 9, the petitioner, which is
available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Previously, in the Federal Register of
May 17, 2010 (75 FR 27434) (FRL–8826–
3), EPA established a time-limited
tolerance exemption for a-(pnonylphenol)-whydroxypoly(oxyethylene) mixture of
dihydrogen phosphate and
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monohydrogen phosphate esters and the
corresponding ammonium, calcium,
magnesium, potassium, sodium, and
zinc salts of the phosphate esters and a(p-nonylphenol)-whydroxypoly(oxyethylene) sulfate,
ammonium, calcium, magnesium,
potassium, sodium, and zinc salts
(herein referred to in this document as
nonylphenol ethoxylate phosphate and
sulfate derivatives or NPEPSDs) with an
expiration date of May 17, 2012. The 2year time limitation was established for
two purposes:
1. To provide time for the
development and submission of
confirmatory toxicity data to address
equivocal results in the available
genotoxicity studies conducted on
NPEPSDs (as described in Unit IV of the
May 17, 2010 final rule); and
2. To provide additional time, should
the initial testing not confirm EPA’s
conclusion regarding the lack of a
cancer concern, for registrants to attain
EPA approval of registration
amendments for reformulation of their
pesticide products to remove NPEPSDs
and to replace existing products with
reformulated products.
In establishing the time-limited
tolerance exemption for NPEPSDs, EPA
stated that if the submitted data
confirmed its conclusion regarding a
lack of cancer concern, the Agency
intended to remove the expiration date
from the tolerance exemption prior to
expiration of the exemption.
III. Inert Ingredient Definition
Inert ingredients are all ingredients
that are not active ingredients as defined
in 40 CFR 153.125 and include, but are
not limited to, the following types of
ingredients (except when they have a
pesticidal efficacy of their own):
Solvents such as alcohols and
hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty
acids; carriers such as clay and
diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
dispensers; microencapsulating agents;
and emulsifiers. The term ‘‘inert’’ is not
intended to imply nontoxicity; the
ingredient may or may not be
chemically active. Generally, EPA has
exempted inert ingredients from the
requirement of a tolerance based on the
low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
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legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. * * *’’
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated that the risks from
aggregate exposure to pesticide
chemical residues under reasonably
foreseeable circumstances will pose no
appreciable risks to human health. In
order to determine the risks from
aggregate exposure to pesticide inert
ingredients, the Agency considers the
toxicity of the inert in conjunction with
possible exposure to residues of the
inert ingredient through food, drinking
water, and through other exposures that
occur as a result of pesticide use in
residential settings. If EPA is able to
determine that a finite tolerance is not
necessary to ensure that there is a
reasonable certainty that no harm will
result from aggregate exposure to the
inert ingredient, an exemption from the
requirement of a tolerance may be
established.
Consistent with FFDCA section
408(c)(2)(A), and the factors specified in
FFDCA section 408(c)(2)(B), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for NPEPSDs
including exposure resulting from the
exemption established by this action.
In the Federal Register of May 17,
2010, EPA issued a final rule
establishing an exemption from the
requirement of a tolerance for residues
of NPEPSDs when used as an inert
ingredient at levels not to exceed 7% in
pesticide formulations applied to
growing crops and raw agricultural
commodities after harvest under 40 CFR
180.910 with an expiration date of May
17, 2012. EPA has determined that
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establishing an exemption from the
requirement of a tolerance for residues
of NPEPSDs when used as an inert
ingredient at levels not to exceed 7% in
pesticide formulations applied to
growing crops and raw agricultural
commodities after harvest will not
significantly change the risk
assessments the Agency relied on to
support the May 17, 2010, tolerance
action, as explained in this unit.
As part of the Agency’s conduct of the
risk assessment in support of the May
17, 2010, tolerance action, it was
determined that there were no acute,
chronic, short- or intermediate term
aggregate risks of concern. With regards
to aggregate cancer risk, the assessment
concluded that based on a weight of the
evidence consideration of the available
data, the Agency believed that cancer
risks would be negligible. However, due
to the equivocal findings in the
mutagenicity data base, the Agency
asked for confirmatory data.
Specifically, EPA recommended that
supporters of the NPEPSD tolerance
exemption perform the following
studies for confirmatory purposes:
A new Ames assay (OCSPP
Harmonized Guideline 870.5100—
Bacterial reverse mutation test) and a
mouse lymphoma assay (OCSPP
Harmonized Guideline 870.5300—in
vitro Mammalian cell gene mutation
test).
A bone marrow assay (OCSPP
Harmonized Guideline 870.5395—
Mammalian erythrocyte micronucleus
test).
Since in vivo mutagenicity studies
such as the bone marrow assay are
generally regarded as more definitive
than in vitro studies, and a negative
result in the bone marrow test may
outweigh whatever results are found in
the Ames test and mouse lymphoma
assay, supporters of the NPEPSD
tolerance exemption were given the
option of conducting the mammalian
erythrocyte micronucleus test in lieu of
the two in vitro mutagenicity studies. If
those data did not confirm EPA’s cancer
conclusion, then EPA would need 2year cancer bioassays in the mouse and
rat (OCSPP Harmonized Guideline
870.4200—Carcinogenicity (mouse) and
OCSPP Harmonized Guideline
870.4300—Combined Chronic Toxicity/
Carcinogenicity (rat)) to make a safety
finding in support of the tolerance
exemption.
In response to the May 17, 2010, final
rule, the JITF, CST 9 conducted an in
vivo Mouse Bone Marrow Erythrocyte
Micronucleus Test Following Oral
Administration (OCSPP Harmonized
Test Guideline 870.5395) of two
representative test compounds,
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poly(oxy-1,2-ethanediyl)-a-(pnonylphenyl)-w-hydroxy-, branched,
phosphates (CAS Reg. No. 68412–53–3)
and poly(oxy-1,2-ethanediyl)-a-sulfo-w(nonylphenoxy), sodium salt (CAS Reg.
No. 9014–90–8). These data were
submitted to the Agency on November
12, 2010 (MRID 48293401 and
48293402).
The data were evaluated by EPA and
it was determined that the test
substances did not induce numerical or
structural chromosomal damage,
providing further confirmation that
NPEPSDs are not of concern for
aggregate cancer risk. Further details of
this evaluation can be found at https://
www.regulations.gov in the document
‘‘Nonylphenol Ethoxylates and Their
Phosphate and Sulfate Derivatives (JITF
CST 9 Inert Ingredients)-Review of
Confirmatory Mutagencity Toxicity
Data’’ in docket ID number EPA–HQ–
OPP–2011–0526.
Refer to the May 17, 2010, Federal
Register document, available at https://
www.regulations.gov, for a detailed
discussion of the aggregate risk
assessment and determination of safety.
Therefore, based on this information
and the findings in the final rule
published in the Federal Register of
May 17, 2010, EPA concludes that there
is a reasonable certainty that no harm
will result to the general population, or
to infants and children from aggregate
exposure to NPEPSD residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
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EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for NPEPSDs.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
for residues of a-(p-nonylphenol)-whydroxypoly(oxyethylene) mixture of
dihydrogen phosphate and
monohydrogen phosphate esters and the
corresponding ammonium, calcium,
magnesium, potassium, sodium, and
zinc salts of the phosphate esters and a(p-nonylphenol)-whydroxypoly(oxyethylene) sulfate,
ammonium, calcium, magnesium,
potassium, sodium, and zinc salts when
used as an inert ingredient at levels not
to exceed 7% in pesticide formulations
applied to growing crops and raw
agricultural commodities after harvest
under 40 CFR 180.910 and in pesticide
formulations applied to animals under
40 CFR 180.930.
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Pub, L. 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VIII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. 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 this final rule in the
Federal Register. This final rule 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: April 26, 2012.
G. Jeffery Herndon,
Acting 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. Section 180.910 is amended by
revising the following entries in the
table of inert ingredients to read as
follows:
■
§ 180.910 Inert ingredients used pre and
post-harvest; exemptions from the
requirement of a tolerance.
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Inert ingredients
Limits
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a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, potassium, sodium, and zinc salts of the phosphate esters; the nonyl
group is a propylene trimer isomer and the poly(oxyethylene) content averages 4–
14 or 30 moles (CAS Reg. Nos. 51811–79–1, 59139–23–0, 67922–57–0, 68412–
53–3, 68553–97–9, 68954–84–7, 99821–14–4, 152143–22–1, 51609–41–7,
37340–60–6, 106151–63–7, 68584–47–4, 52503–15–8, 68458–49–1).
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Not to exceed 7% of pesticide formulation.
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Surfactants, related adjuvants of surfactants.
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a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts the nonyl group is propylene trimer isomer and the poly(oxyethylene) content averages 4 moles (CAS Reg. Nos. 9014–
90–8, 9051–57–4, 9081–17–8, 68649–55–8, 68891–33–8.
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Not to exceed 7% of pesticide formulation.
*
Surfactants, related adjuvants of surfactants.
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Inert ingredients
*
*
Limits
*
3. Section 180.930 is amended by
revising the following entries in the
*
*
*
*
§ 180.930 Inert ingredients applied to
animas; exemptions from the requirement
of a tolerance.
table of inert ingredients to read as
follows:
■
Uses
*
*
*
*
*
Inert ingredients
Limits
*
*
*
*
a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, potassium, sodium, and zinc salts of the phosphate esters; the nonyl
group is a propylene trimer isomer and the poly(oxyethylene) content averages 4–
14 or 30 moles (CAS Reg. Nos. 51811–79–1, 59139–23–0, 67922–57–0, 68412–
53–3, 68553–97–9, 68954–84–7, 99821–14–4, 152143–22–1, 51609–41–7,
37340–60–6, 106151–63–7, 68584–47–4, 52503–15–8, 68458–49–1).
a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts the nonyl group is propylene trimer isomer and the poly(oxyethylene) content averages 4 moles (CAS Reg. Nos. 9014–
90–8, 9051–57–4, 9081–17–8, 68649–55–8, 68891–33–8.
*
*
Not to exceed 7% of pesticide formulation.
*
Surfactants, related adjuvants of surfactants.
Not to exceed 7% of pesticide formulation.
Surfactants, related adjuvants of surfactants.
*
*
*
[FR Doc. 2012–10933 Filed 5–8–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0261; FRL–9339–6]
Ametoctradin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of ametoctradin
in or on multiple commodities which
are identified and discussed later in this
document. BASF Corporation requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May
9, 2012. Objections and requests for
hearings must be received on or before
July 9, 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).
SUMMARY:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2010–0261. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
sroberts on DSK5SPTVN1PROD with RULES
ADDRESSES:
VerDate Mar<15>2010
15:36 May 08, 2012
Jkt 226001
*
*
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Shaunta Hill, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 347–8961; email address:
hill.shaunta@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. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
PO 00000
Frm 00018
Fmt 4700
Uses
Sfmt 4700
*
*
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
E:\FR\FM\09MYR1.SGM
09MYR1
Agencies
[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Rules and Regulations]
[Pages 27126-27130]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10933]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0526; FRL-9340-2]
[alpha]-(p-Nonylphenol)-[omega]-hydroxypoly(oxyethylene) Sulfate
and Phosphate Esters; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of [alpha]-(p-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, potassium, sodium, and zinc salts of the phosphate esters
and [alpha]-(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene) sulfate,
ammonium, calcium, magnesium, potassium, sodium, and zinc salts when
used as inert ingredients at levels not to exceed 7% in pesticide
formulations applied to growing crops, raw agricultural commodities
after harvest and animals. The Joint Inerts Task Force, (JITF) Cluster
Support Team Number (CST) 9 submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of [alpha]-(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene)
mixture of dihydrogen phosphate and monohydrogen phosphate esters and
the corresponding ammonium, calcium, magnesium, potassium, sodium, and
zinc salts of the phosphate esters and [alpha]-(p-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium,
potassium, sodium, and zinc salts.
DATES: This regulation is effective May 9, 2012. Objections and
requests for hearings must be received on or before July 9, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0526. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 308-8811; email address: leifer.kerry@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.
Potentially
[[Page 27127]]
affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
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. To access the OCSPP test guidelines referenced in this
document electronically, please go to https://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0526 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
July 9, 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 that does not contain 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0526, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP)
Regulatory Public Docket (7502P), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background
In the Federal Register of August 26, 2011 (76 FR 53372) (FRL-8884-
9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide petition (PP 1E7860) by Joint
Inerts Task Force, Cluster Support Team 9, c/o CropLife America, 1156
15th St. NW., Suite 400, Washington, DC 20005. The petition requested
that 40 CFR 180.910 and 40 CFR 180.930 be amended by establishing an
exemption from the requirement of a tolerance for residues of [alpha]-
(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene) mixture of dihydrogen
phosphate and monohydrogen phosphate esters and the corresponding
ammonium, calcium, magnesium, potassium, sodium, and zinc salts of the
phosphate esters and [alpha]-(p-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium,
potassium, sodium, and zinc salts when used as inert ingredients at
levels not to exceed 7% in pesticide formulations applied to growing
crops and raw agricultural commodities after harvest and to animals.
That notice referenced a summary of the petition prepared by JITF, CST
9, the petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.
Previously, in the Federal Register of May 17, 2010 (75 FR 27434)
(FRL-8826-3), EPA established a time-limited tolerance exemption for
[alpha]-(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene) mixture of
dihydrogen phosphate and monohydrogen phosphate esters and the
corresponding ammonium, calcium, magnesium, potassium, sodium, and zinc
salts of the phosphate esters and [alpha]-(p-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium,
potassium, sodium, and zinc salts (herein referred to in this document
as nonylphenol ethoxylate phosphate and sulfate derivatives or NPEPSDs)
with an expiration date of May 17, 2012. The 2-year time limitation was
established for two purposes:
1. To provide time for the development and submission of
confirmatory toxicity data to address equivocal results in the
available genotoxicity studies conducted on NPEPSDs (as described in
Unit IV of the May 17, 2010 final rule); and
2. To provide additional time, should the initial testing not
confirm EPA's conclusion regarding the lack of a cancer concern, for
registrants to attain EPA approval of registration amendments for
reformulation of their pesticide products to remove NPEPSDs and to
replace existing products with reformulated products.
In establishing the time-limited tolerance exemption for NPEPSDs,
EPA stated that if the submitted data confirmed its conclusion
regarding a lack of cancer concern, the Agency intended to remove the
expiration date from the tolerance exemption prior to expiration of the
exemption.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the
[[Page 27128]]
legal limit for a pesticide chemical residue in or on a food) only if
EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii)
of FFDCA defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C) of
FFDCA requires EPA to give special consideration to exposure of infants
and children to the pesticide chemical residue in establishing a
tolerance and to ``ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to the
pesticide chemical residue. * * *''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for NPEPSDs including exposure
resulting from the exemption established by this action.
In the Federal Register of May 17, 2010, EPA issued a final rule
establishing an exemption from the requirement of a tolerance for
residues of NPEPSDs when used as an inert ingredient at levels not to
exceed 7% in pesticide formulations applied to growing crops and raw
agricultural commodities after harvest under 40 CFR 180.910 with an
expiration date of May 17, 2012. EPA has determined that establishing
an exemption from the requirement of a tolerance for residues of
NPEPSDs when used as an inert ingredient at levels not to exceed 7% in
pesticide formulations applied to growing crops and raw agricultural
commodities after harvest will not significantly change the risk
assessments the Agency relied on to support the May 17, 2010, tolerance
action, as explained in this unit.
As part of the Agency's conduct of the risk assessment in support
of the May 17, 2010, tolerance action, it was determined that there
were no acute, chronic, short- or intermediate term aggregate risks of
concern. With regards to aggregate cancer risk, the assessment
concluded that based on a weight of the evidence consideration of the
available data, the Agency believed that cancer risks would be
negligible. However, due to the equivocal findings in the mutagenicity
data base, the Agency asked for confirmatory data. Specifically, EPA
recommended that supporters of the NPEPSD tolerance exemption perform
the following studies for confirmatory purposes:
A new Ames assay (OCSPP Harmonized Guideline 870.5100--Bacterial
reverse mutation test) and a mouse lymphoma assay (OCSPP Harmonized
Guideline 870.5300--in vitro Mammalian cell gene mutation test).
A bone marrow assay (OCSPP Harmonized Guideline 870.5395--Mammalian
erythrocyte micronucleus test).
Since in vivo mutagenicity studies such as the bone marrow assay
are generally regarded as more definitive than in vitro studies, and a
negative result in the bone marrow test may outweigh whatever results
are found in the Ames test and mouse lymphoma assay, supporters of the
NPEPSD tolerance exemption were given the option of conducting the
mammalian erythrocyte micronucleus test in lieu of the two in vitro
mutagenicity studies. If those data did not confirm EPA's cancer
conclusion, then EPA would need 2-year cancer bioassays in the mouse
and rat (OCSPP Harmonized Guideline 870.4200--Carcinogenicity (mouse)
and OCSPP Harmonized Guideline 870.4300--Combined Chronic Toxicity/
Carcinogenicity (rat)) to make a safety finding in support of the
tolerance exemption.
In response to the May 17, 2010, final rule, the JITF, CST 9
conducted an in vivo Mouse Bone Marrow Erythrocyte Micronucleus Test
Following Oral Administration (OCSPP Harmonized Test Guideline
870.5395) of two representative test compounds, poly(oxy-1,2-
ethanediyl)-[alpha]-(p-nonylphenyl)-[omega]-hydroxy-, branched,
phosphates (CAS Reg. No. 68412-53-3) and poly(oxy-1,2-ethanediyl)-
[alpha]-sulfo-[omega]-(nonylphenoxy), sodium salt (CAS Reg. No. 9014-
90-8). These data were submitted to the Agency on November 12, 2010
(MRID 48293401 and 48293402).
The data were evaluated by EPA and it was determined that the test
substances did not induce numerical or structural chromosomal damage,
providing further confirmation that NPEPSDs are not of concern for
aggregate cancer risk. Further details of this evaluation can be found
at https://www.regulations.gov in the document ``Nonylphenol Ethoxylates
and Their Phosphate and Sulfate Derivatives (JITF CST 9 Inert
Ingredients)-Review of Confirmatory Mutagencity Toxicity Data'' in
docket ID number EPA-HQ-OPP-2011-0526.
Refer to the May 17, 2010, Federal Register document, available at
https://www.regulations.gov, for a detailed discussion of the aggregate
risk assessment and determination of safety.
Therefore, based on this information and the findings in the final
rule published in the Federal Register of May 17, 2010, EPA concludes
that there is a reasonable certainty that no harm will result to the
general population, or to infants and children from aggregate exposure
to NPEPSD residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that
[[Page 27129]]
EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for NPEPSDs.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of [alpha]-(p-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, potassium, sodium, and zinc salts of the phosphate esters
and [alpha]-(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene) sulfate,
ammonium, calcium, magnesium, potassium, sodium, and zinc salts when
used as an inert ingredient at levels not to exceed 7% in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest under 40 CFR 180.910 and in pesticide formulations
applied to animals under 40 CFR 180.930.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub, L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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: April 26, 2012.
G. Jeffery Herndon,
Acting 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. Section 180.910 is amended by revising the following entries in the
table of inert ingredients to read as follows:
Sec. 180.910 Inert ingredients used pre and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
[alpha]-(p-Nonylphenol)-[omega]- Not to exceed 7% Surfactants,
hydroxypoly(oxyethylene) mixture of pesticide related
of dihydrogen phosphate and formulation. adjuvants of
monohydrogen phosphate esters surfactants.
and the corresponding ammonium,
calcium, magnesium, potassium,
sodium, and zinc salts of the
phosphate esters; the nonyl
group is a propylene trimer
isomer and the poly(oxyethylene)
content averages 4-14 or 30
moles (CAS Reg. Nos. 51811-79-1,
59139-23-0, 67922-57-0, 68412-53-
3, 68553-97-9, 68954-84-7, 99821-
14-4, 152143-22-1, 51609-41-7,
37340-60-6, 106151-63-7, 68584-
47-4, 52503-15-8, 68458-49-1).
* * * * * * *
[alpha]-(p-Nonylphenol)-[omega]- Not to exceed 7% Surfactants,
hydroxypoly(oxyethylene) of pesticide related
sulfate, ammonium, calcium, formulation. adjuvants of
magnesium, potassium, sodium, surfactants.
and zinc salts the nonyl group
is propylene trimer isomer and
the poly(oxyethylene) content
averages 4 moles (CAS Reg. Nos.
9014-90-8, 9051-57-4, 9081-17-8,
68649-55-8, 68891-33-8.
[[Page 27130]]
* * * * * * *
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0
3. Section 180.930 is amended by revising the following entries in the
table of inert ingredients to read as follows:
Sec. 180.930 Inert ingredients applied to animas; exemptions from the
requirement of a tolerance.
* * * * *
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Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
[alpha]-(p-Nonylphenol)-[omega]- Not to exceed 7% Surfactants,
hydroxypoly(oxyethylene) mixture of pesticide related
of dihydrogen phosphate and formulation. adjuvants of
monohydrogen phosphate esters surfactants.
and the corresponding ammonium,
calcium, magnesium, potassium,
sodium, and zinc salts of the
phosphate esters; the nonyl
group is a propylene trimer
isomer and the poly(oxyethylene)
content averages 4-14 or 30
moles (CAS Reg. Nos. 51811-79-1,
59139-23-0, 67922-57-0, 68412-53-
3, 68553-97-9, 68954-84-7, 99821-
14-4, 152143-22-1, 51609-41-7,
37340-60-6, 106151-63-7, 68584-
47-4, 52503-15-8, 68458-49-1).
[alpha]-(p-Nonylphenol)-[omega]- Not to exceed 7% Surfactants,
hydroxypoly(oxyethylene) of pesticide related
sulfate, ammonium, calcium, formulation. adjuvants of
magnesium, potassium, sodium, surfactants.
and zinc salts the nonyl group
is propylene trimer isomer and
the poly(oxyethylene) content
averages 4 moles (CAS Reg. Nos.
9014-90-8, 9051-57-4, 9081-17-8,
68649-55-8, 68891-33-8.
* * * * * * *
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[FR Doc. 2012-10933 Filed 5-8-12; 8:45 am]
BILLING CODE 6560-50-P