[Federal Register Volume 74, Number 195 (Friday, October 9, 2009)]
[Rules and Regulations]
[Pages 52148-52151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24415]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0601; FRL-8794-1]
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.
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SUMMARY: This document moves the effective date of the revocation of
six inert ingredient tolerance exemptions as
[[Page 52149]]
set forth in the Federal Register on August 7, 2009 (74 FR 39543).
DATES: In the final rule published August 9, 2006 (71 FR 45415), and
delayed on August 4, 2008 (73 FR 45312), and August 7, 2009 (74 FR
39543):
1. The effective date is delayed from October 9, 2009, to February
9, 2010, for the following amendments to Sec. 180.910: 2.m., n., and
cc.
2. The effective date is delayed from October 9, 2009, to February
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
December 8, 2009, 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 http://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 http://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: [email protected].
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:
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 Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's e-CFR site at http://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. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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 on or before December 8, 2009.
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 your copies, identified by docket ID
number EPA-HQ-OPP-2009-0601, by one of the following methods:
Federal eRulemaking Portal: http://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 had insufficient data to make the safety finding of FFDCA
section 408(c)(2) and revoked the inert ingredient tolerance 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
[[Page 52150]]
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.
B. Moving the Effective Date of the Revocation for Six Tolerance
Exemptions
Following the publication of the August 7, 2009, final rule
delaying the effective date for the six revoked tolerance exemptions,
EPA received significant additional toxicity, metabolism and
environmental fate data from the petitioners in further support of
pesticide tolerance petitions 8E7466 and 8E7478 which have been
determined by the Agency to have a significant bearing on its safety
evaluation under FFDCA section 408(c)(2) of the petition proposing that
these exemptions be reestablished. Much of the data submitted were not
previously available and thus could not have been submitted sooner.
EPA, therefore, concludes that additional time is necessary to complete
the safety determinations for these six tolerance exemptions and that
the effective date of the revocation of these tolerance exemptions
should be moved by four months to February 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 August 7,
2009 (74 FR 39543) 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 February 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 a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by
[[Page 52151]]
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: October 5, 2009.
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), and August 7, 2009 (74 FR
39543) the effective date is delayed from October 9, 2009, to February
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), and August 7, 2009 (74 FR
39543) the effective date is delayed from October 9, 2009, to February
9, 2010, for the following amendmentsto Sec. 180.930: 4.t., u., and v.
[FR Doc. E9-24415 Filed 10-6-09; 4:15 pm]
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