Inert Ingredients; Extension of Effective Date of Revocation of Certain Tolerance Exemptions with Insufficient Data for Reassessment, 6314-6316 [2010-2801]
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Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations
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[FR Doc. 2010–2706 Filed 2–8–10; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0601; FRL–8812–3]
Inert Ingredients; Extension of
Effective Date of Revocation of Certain
Tolerance Exemptions with Insufficient
Data for Reassessment
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AGENCY: Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
SUMMARY: This document moves the
effective date of the revocation of six
inert ingredient tolerance exemptions as
set forth in the Federal Register on
October 9, 2009 (74 FR 52148).
DATES: In the final rule published
August 9, 2006 (71 FR 45415), and
delayed on August 4, 2008 (73 FR
45312), August 7, 2009 (74 FR 39543),
and October 9, 2009 (74 FR 52148):
1. The effective date is delayed from
February 9, 2010, to May 9, 2010, for the
following amendments to §180.910:
2.m., n., and cc.
2. The effective date is delayed from
February 9, 2010, to May 9, 2010, for the
following amendments to §180.930: 4.t.,
u., and v.
Objections and requests for hearings
must be received on or before April 12,
2010, 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–2009–0601. 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
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14:32 Feb 08, 2010
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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; e-mail 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
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).
• 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 Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 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
PO 00000
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Fmt 4700
Sfmt 4700
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2009–0601 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before April 12, 2010.
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 that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2009–0601, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
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 and Statutory Findings
A. Background
In a final rule published in the
Federal Register on August 9, 2006 (71
FR 45415)(FRL–8084–1), EPA revoked
inert ingredient tolerance exemptions
because insufficient data were available
to the Agency to make the safety
determination required by Federal Food,
Drug, and Cosmetic Act (FFDCA)
section 408(c)(2). In reassessing the
safety of the tolerance exemptions, EPA
considered the validity, completeness,
and reliability of the data that are
available to the Agency [FFDCA section
408 (b)(2)(D)] and the available
information concerning the special
susceptibility of infants and children
(including developmental effects from
in utero exposure) [FFDCA section
408(b)(2)(C)]. EPA concluded it has
insufficient data to make the safety
finding of FFDCA section 408(c)(2) and
revoked the inert ingredient tolerance
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Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations
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exemptions identified in the final rule
under 40 CFR 180.910, 180.920,
180.930, and 180.940, with the
revocations effective on August 9, 2008.
In a direct final rule published in the
Federal Register on August 4, 2008 (73
FR 45312)(FRL–8372–7), EPA moved
the effective date of the revocation of
certain inert ingredient tolerance
exemptions from August 9, 2008, until
August 9, 2009. This determination was
made based on requests for an extension
of the revocation date from pesticide
registrants and inert ingredient
manufacturers who had demonstrated
their intent to support certain inert
ingredient tolerance exemptions and
who had provided data development
plans and schedules for data submission
to the Agency. In a subsequent direct
final rule published in the Federal
Register on August 7, 2009 (74 FR
39543)(FRL–8431–8), EPA moved the
effective date of the revocation of six
inert ingredient tolerance exemptions
from August 9, 2009, until October 9,
2009. This action was based on the fact
that EPA had received petitions for the
establishment of tolerance exemptions
which included the submission of data
for these inert ingredients. Notices of
filing of these petitions (PP 8E7466 and
PP 8E7478) were published in the
Federal Register on March 25, 2009 (74
FR 12856)(FRL–8399–4). The August 7,
2009, direct final rule was published to
allow for the completion of the Agency’s
risk assessments needed to evaluate the
petitions and to complete the safety
determinations for the six tolerance
exemptions. The October 9, 2009 (74 FR
52148)(FRL–8794–1), direct final rule
was published to move the effective
date of the revocation of six inert
ingredient tolerance exemptions from
October 9, 2009 to February 9, 2010 to
allow for the review and evaluation of
significant additional toxicity,
metabolism and environmental fate data
submitted by the petitioners in further
support of pesticide tolerance petitions
8E7466 and 8E7478.
B. Moving the Effective Date of the
Revocation for Six Tolerance
Exemptions
Following the publication of the
October 9, 2009, final rule delaying the
effective date for the six revoked
tolerance exemptions, EPA did its own
search of the public literature and found
new information that the Agency
determined would have significant
bearing on its safety evaluation under
FFDCA section 408(c)(2) of the petitions
(8E7466 and 8E7478) which are
proposing that these exemptions be
reestablished. EPA, therefore, concludes
that additional time is necessary to
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14:32 Feb 08, 2010
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complete the safety determinations for
these six tolerance exemptions in order
to allow time to review and evaluate
this new information and that the
effective date of the revocation of these
tolerance exemptions should be moved
by three months to May 9, 2010.
C. What is the Agency’s Authority for
Taking this Action?
A ‘‘tolerance’’ represents the
maximum level for residues of pesticide
chemicals legally allowed in or on raw
agricultural commodities and processed
foods. Section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA, Public Law
104–170, authorizes the establishment
of tolerances, exemptions from tolerance
requirements, modifications in
tolerances, and revocation of tolerances
for residues of pesticide chemicals in or
on raw agricultural commodities and
processed foods. Without a tolerance or
exemption, food containing pesticide
residues is considered to be unsafe and
therefore ‘‘adulterated’’ under FFDCA
section 402(a), 21 U.S.C. 342(a). Such
food may not be distributed in interstate
commerce (21 U.S.C. 331(a)). For a fooduse pesticide to be sold and distributed,
the pesticide must not only have
appropriate tolerances under FFDCA,
but also must be registered under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA)(7 U.S.C. 136 et
seq.). Food-use pesticides not registered
in the United States must have
tolerances in order for commodities
treated with those pesticides to be
imported into the United States. Under
FFDCA section 408(e)(1)(B), 21 U.S.C.
346a(e)(1)(B), EPA may take action
establishing, modifying, suspending, or
revoking a tolerance exemption.
III. Delayed Effective Date for Certain
Tolerance Exemptions
The amendatory designations listed in
this unit are reprinted from the final
rule published in the Federal Register
issue of October 9, 2009 (74 FR 52148)
for the convenience of the user. The
structure mirrors the amendatory
designations in the original document.
The amendatory designations shown are
those with the effective date delayed
until May 9, 2010.
Section 180.910
m. a-(p-Nonylphenyl)-whydroxypoly(oxyethylene) mixture of
dihydrogen phosphate and
monohydrogen phosphate esters and the
corresponding ammonium, calcium,
magnesium, monoethanolamine,
potassium, sodium, and zinc salts of the
phosphate esters; the nonyl group is a
propylene trimer isomer and the poly
PO 00000
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Fmt 4700
Sfmt 4700
6315
(oxyethylene) content averages 4–14
moles or 30 moles.
n. a-(p-Nonylphenyl)-whydroxypoly(oxyethylene)sulfate,
ammonium, calcium, magnesium,
potassium, sodium, and zinc salts; the
nonyl group is a propylene trimer
isomer and the poly(oxyethylene)
content averages 4 moles.
cc. a-[p-(1,1,3,3Tetramethylbutyl)phenyl]-whydroxypoly(oxyethylene) produced by
the condensation of 1 mole of p-(1,1,3,3tetramethylbutyl)phenol with a range of
1–14 or 30–70 moles of ethylene oxide:
if a blend of products is used, the
average range number of moles of
ethylene oxide reacted to produce any
product that is a component of the
blend shall be in the range of 1–14 or
30–70.
Section 180.930
t. a-(p-Nonylphenyl)-whydroxypoly(oxyethylene) mixture of
dihydrogen phosphate and
monohydrogen phosphate esters and the
corresponding ammonium, calcium,
magnesium, monoethanolamine,
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 moles.
u. a-(p-Nonylphenyl)-whydroxypoly(oxyethylene)sulfate, and
its ammonium, calcium, magnesium,
potassium, sodium, and zinc salts; the
nonyl group is a propylene trimer
isomer and the poly(oxyethylene)
content averages 4 moles.
v. a-(p-Nonylphenyl)-whydroxypoly(oxyethylene)sulfate, and
its ammonium, calcium, magnesium,
monoethanolamine, potassium, sodium,
and zinc salts; the nonyl group is a
propylene trimer isomer and the
poly(oxyethylene) content averages 4–
14 or 30–90 moles of ethylene oxide.
IV. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to petitions 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
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Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations
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Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 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).
V. 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
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14:32 Feb 08, 2010
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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: February 2, 2010.
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.
§180.910
ACTION:
Correcting amendments.
SUMMARY: On January 15, 2010, the
Commission released a Report and
Order in the matter of ‘‘Revisions to
Rules Authorizing the Operation of Low
Power Auxiliary Stations in the 698–806
MHz Band; Public Interest Spectrum
Coalition, Petition for Rulemaking
Regarding Low Power Auxiliary
Stations, including Wireless
Microphones, and the Digital Television
Transition.’’ This document contains
corrections to the final regulations that
appeared in the Federal Register of
January 22, 2010 (75 FR 3622).
DATES:
February 9, 2010.
FOR FURTHER INFORMATION CONTACT: Paul
D’Ari, Wireless Telecommunications
Bureau, (202) 418–1550, e-mail
Paul.Dari@fcc.gov, or Hugh Van Tuyl,
Office of Engineering and Technology,
(202) 418–7506, e-mail
Hugh.VanTuyl@fcc.gov.
SUPPLEMENTARY INFORMATION:
Background
[AMENDED]
2. In the final rule published August
9, 2006 (71 FR 45415), and delayed on
August 4, 2008 (73 FR 45312), August
7, 2009 (74 FR 39543) and October 9,
2009 (74 FR 52148) the effective date is
delayed from February 9, 2010, to May
9, 2010, for the following amendments
to §180.910: 2.m., n., and cc.
The Federal Communications
Commission published a document
amending part 2 in the Federal Register
of January 22, 2010 (75 FR 3622). The
Commission makes the following
correction to § 2.106 of the rules.
§180.930
As published, the final regulations
contain an error, which requires
immediate correction.
■
[AMENDED]
3. In the final rule published August
9, 2006 (71 FR 45415), and delayed on
August 4, 2008 (73 FR 45312), August
7, 2009 (74 FR 39543) and October 9,
2009 (74 FR 52148) the effective date is
delayed from February 9, 2010, to May
9, 2010, for the following amendments
to §180.930: 4.t., u., and v.
■
[FR Doc. 2010–2801 Filed 2–8–10; 8:45 am]
BILLING CODE 6560–50–S
47 CFR Part 2
[WT Docket No. 08–166, 08–167; ET Docket
No. 10–24; FCC 10–16]
Revisions to Rules Authorizing the
Operation of Low Power Auxiliary
Stations in the 698–806 MHz Band;
Public Interest Spectrum Coalition,
Petition for Rulemaking Regarding
Low Power Auxiliary Stations,
Including Wireless Microphones, and
the Digital Television Transition
AGENCY: Federal Communications
Commission.
Frm 00018
Fmt 4700
List of Subjects in 47 CFR Part 2
Communications equipment.
Federal Communications Commission.
Marlene H. Dortch,
Secretary.
Accordingly, 47 CFR part 2 is
corrected by making the following
correcting amendments:
■
FEDERAL COMMUNICATIONS
COMMISSION
PO 00000
Need for Correction
Sfmt 4700
PART 2—FREQUENCY ALLOCATIONS
AND RADIO TREATY MATTERS;
GENERAL RULES AND REGULATIONS
1. The authority citation for part 2
continues to read as follows:
■
Authority: 47 U.S.C. 154, 302a, 303, and
336, unless otherwise noted.
2. Section 2.106, Table of Frequency
Allocations, is amended by revising
page 27 and footnote NG 159 to read as
follows:
■
§ 2.106
*
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Table of Frequency Allocations.
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Agencies
[Federal Register Volume 75, Number 26 (Tuesday, February 9, 2010)]
[Rules and Regulations]
[Pages 6314-6316]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-2801]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0601; FRL-8812-3]
Inert Ingredients; Extension of Effective Date of Revocation of
Certain Tolerance Exemptions with Insufficient Data for Reassessment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: This document moves the effective date of the revocation of
six inert ingredient tolerance exemptions as set forth in the Federal
Register on October 9, 2009 (74 FR 52148).
DATES: In the final rule published August 9, 2006 (71 FR 45415), and
delayed on August 4, 2008 (73 FR 45312), August 7, 2009 (74 FR 39543),
and October 9, 2009 (74 FR 52148):
1. The effective date is delayed from February 9, 2010, to May 9,
2010, for the following amendments to Sec. 180.910: 2.m., n., and cc.
2. The effective date is delayed from February 9, 2010, to May 9,
2010, for the following amendments to Sec. 180.930: 4.t., u., and v.
Objections and requests for hearings must be received on or before
April 12, 2010, 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-2009-0601. 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; e-mail 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 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).
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 Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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-2009-0601 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before April 12, 2010.
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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0601, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line 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 and Statutory Findings
A. Background
In a final rule published in the Federal Register on August 9, 2006
(71 FR 45415)(FRL-8084-1), EPA revoked inert ingredient tolerance
exemptions because insufficient data were available to the Agency to
make the safety determination required by Federal Food, Drug, and
Cosmetic Act (FFDCA) section 408(c)(2). In reassessing the safety of
the tolerance exemptions, EPA considered the validity, completeness,
and reliability of the data that are available to the Agency [FFDCA
section 408 (b)(2)(D)] and the available information concerning the
special susceptibility of infants and children (including developmental
effects from in utero exposure) [FFDCA section 408(b)(2)(C)]. EPA
concluded it has insufficient data to make the safety finding of FFDCA
section 408(c)(2) and revoked the inert ingredient tolerance
[[Page 6315]]
exemptions identified in the final rule under 40 CFR 180.910, 180.920,
180.930, and 180.940, with the revocations effective on August 9, 2008.
In a direct final rule published in the Federal Register on August
4, 2008 (73 FR 45312)(FRL-8372-7), EPA moved the effective date of the
revocation of certain inert ingredient tolerance exemptions from August
9, 2008, until August 9, 2009. This determination was made based on
requests for an extension of the revocation date from pesticide
registrants and inert ingredient manufacturers who had demonstrated
their intent to support certain inert ingredient tolerance exemptions
and who had provided data development plans and schedules for data
submission to the Agency. In a subsequent direct final rule published
in the Federal Register on August 7, 2009 (74 FR 39543)(FRL-8431-8),
EPA moved the effective date of the revocation of six inert ingredient
tolerance exemptions from August 9, 2009, until October 9, 2009. This
action was based on the fact that EPA had received petitions for the
establishment of tolerance exemptions which included the submission of
data for these inert ingredients. Notices of filing of these petitions
(PP 8E7466 and PP 8E7478) were published in the Federal Register on
March 25, 2009 (74 FR 12856)(FRL-8399-4). The August 7, 2009, direct
final rule was published to allow for the completion of the Agency's
risk assessments needed to evaluate the petitions and to complete the
safety determinations for the six tolerance exemptions. The October 9,
2009 (74 FR 52148)(FRL-8794-1), direct final rule was published to move
the effective date of the revocation of six inert ingredient tolerance
exemptions from October 9, 2009 to February 9, 2010 to allow for the
review and evaluation of significant additional toxicity, metabolism
and environmental fate data submitted by the petitioners in further
support of pesticide tolerance petitions 8E7466 and 8E7478.
B. Moving the Effective Date of the Revocation for Six Tolerance
Exemptions
Following the publication of the October 9, 2009, final rule
delaying the effective date for the six revoked tolerance exemptions,
EPA did its own search of the public literature and found new
information that the Agency determined would have significant bearing
on its safety evaluation under FFDCA section 408(c)(2) of the petitions
(8E7466 and 8E7478) which are proposing that these exemptions be
reestablished. EPA, therefore, concludes that additional time is
necessary to complete the safety determinations for these six tolerance
exemptions in order to allow time to review and evaluate this new
information and that the effective date of the revocation of these
tolerance exemptions should be moved by three months to May 9, 2010.
C. What is the Agency's Authority for Taking this Action?
A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a,
as amended by FQPA, Public Law 104-170, authorizes the establishment of
tolerances, exemptions from tolerance requirements, modifications in
tolerances, and revocation of tolerances for residues of pesticide
chemicals in or on raw agricultural commodities and processed foods.
Without a tolerance or exemption, food containing pesticide residues is
considered to be unsafe and therefore ``adulterated'' under FFDCA
section 402(a), 21 U.S.C. 342(a). Such food may not be distributed in
interstate commerce (21 U.S.C. 331(a)). For a food-use pesticide to be
sold and distributed, the pesticide must not only have appropriate
tolerances under FFDCA, but also must be registered under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA)(7 U.S.C. 136 et
seq.). Food-use pesticides not registered in the United States must
have tolerances in order for commodities treated with those pesticides
to be imported into the United States. Under FFDCA section
408(e)(1)(B), 21 U.S.C. 346a(e)(1)(B), EPA may take action
establishing, modifying, suspending, or revoking a tolerance exemption.
III. Delayed Effective Date for Certain Tolerance Exemptions
The amendatory designations listed in this unit are reprinted from
the final rule published in the Federal Register issue of October 9,
2009 (74 FR 52148) for the convenience of the user. The structure
mirrors the amendatory designations in the original document. The
amendatory designations shown are those with the effective date delayed
until May 9, 2010.
Section 180.910
m. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene)
mixture of dihydrogen phosphate and monohydrogen phosphate esters and
the corresponding ammonium, calcium, magnesium, monoethanolamine,
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 moles or 30 moles.
n. [alpha]-(p-Nonylphenyl)-[omega]-
hydroxypoly(oxyethylene)sulfate, ammonium, calcium, magnesium,
potassium, sodium, and zinc salts; the nonyl group is a propylene
trimer isomer and the poly(oxyethylene) content averages 4 moles.
cc. [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of
ethylene oxide: if a blend of products is used, the average range
number of moles of ethylene oxide reacted to produce any product that
is a component of the blend shall be in the range of 1-14 or 30-70.
Section 180.930
t. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene) mixture
of dihydrogen phosphate and monohydrogen phosphate esters and the
corresponding ammonium, calcium, magnesium, monoethanolamine,
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 moles.
u. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene)sulfate,
and its ammonium, calcium, magnesium, potassium, sodium, and zinc
salts; the nonyl group is a propylene trimer isomer and the
poly(oxyethylene) content averages 4 moles.
v. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene)sulfate,
and its ammonium, calcium, magnesium, monoethanolamine, potassium,
sodium, and zinc salts; the nonyl group is a propylene trimer isomer
and the poly(oxyethylene) content averages 4-14 or 30-90 moles of
ethylene oxide.
IV. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to petitions 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
[[Page 6316]]
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 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).
V. 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: February 2, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
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.
Sec. 180.910 [AMENDED]
0
2. In the final rule published August 9, 2006 (71 FR 45415), and
delayed on August 4, 2008 (73 FR 45312), August 7, 2009 (74 FR 39543)
and October 9, 2009 (74 FR 52148) the effective date is delayed from
February 9, 2010, to May 9, 2010, for the following amendments to
Sec. 180.910: 2.m., n., and cc.
Sec. 180.930 [AMENDED]
0
3. In the final rule published August 9, 2006 (71 FR 45415), and
delayed on August 4, 2008 (73 FR 45312), August 7, 2009 (74 FR 39543)
and October 9, 2009 (74 FR 52148) the effective date is delayed from
February 9, 2010, to May 9, 2010, for the following amendments to
Sec. 180.930: 4.t., u., and v.
[FR Doc. 2010-2801 Filed 2-8-10; 8:45 am]
BILLING CODE 6560-50-S