Oxirane, 2-methyl-, polymer with oxirane, mono [2-[2-(2-)butoxymethylethoxy))methylethoxyl] ether; Tolerance Exemption, 41283-41286 [E8-16317]
Download as PDF
Federal Register / Vol. 73, No. 139 / Friday, July 18, 2008 / Rules and Regulations
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the Clean
Air Act, petitions for judicial review of
this action must be filed in the United
States Court of Appeals for the
appropriate circuit by September 16,
2008. Filing a petition for
reconsideration by the Administrator of
this final rule does not affect the finality
of this rule for the purposes of judicial
review nor does it extend the time
within which a petition for judicial
review may be filed, and shall not
postpone the effectiveness of such rule
or action. This action may not be
challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Ozone, Reporting and recordkeeping
requirements, Volatile organic
compounds.
Dated: July 3, 2008.
Kathleen H. Johnson,
Acting Regional Administrator, Region IX.
Chapter I, title 40 of the Code of
Federal Regulations is amended as
follows:
I
PART 52—[AMENDED]
1. The authority citation for Part 52
continues to read as follows:
I
Authority: 42 U.S.C. 7401 et seq.
Subpart F—California
2. Section 52.220 is amended by
adding paragraph (c)(355) to read as
follows:
I
§ 52.220
Identification of plan.
rwilkins on PROD1PC63 with RULES
*
*
*
*
*
(c) * * *
(355) The following plan revision was
submitted on November 30, 2007, by the
Governor’s designee.
(i) Incorporation by reference.
(A) California Air Resources Board.
(1) Attachment 3 to Executive Order
S–07–003, Appendix H, Revised
Proposed Revision to the Pesticide
Element of the 1994 Ozone SIP for the
Ventura County Nonattainment Area
(August 13, 2007).
(2) California Air Resources Board,
Executive Order S–07–003, November
30, 2007; to Wit: Revised Pesticide
VerDate Aug<31>2005
16:19 Jul 17, 2008
Jkt 214001
Element of the 1994 Ozone SIP for the
Ventura County Nonattainment Area.
[FR Doc. E8–16388 Filed 7–17–08; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0254; FRL–8371–7]
Oxirane, 2-methyl-, polymer with
oxirane, mono [2-[2-(2-)
butoxymethylethoxy))methylethoxyl]
ether; Tolerance Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of oxirane, 2methyl-, polymer with oxirane, mono
[2-[2-(2-)butoxymethylethoxy)
methylethoxy]methylethyl] ether; (CAS
Reg. No. 926031–36–9) when used as an
inert ingredient in a pesticide chemical
formulation. Rhodia, Inc. c/o SciReg,
Inc., submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA)
requesting an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of oxirane, 2-methyl-,
polymer with oxirane, mono [2-[2-(2)
butoxymethylethoxy))methylethoxy]
methylethyl] ether.
DATES: This regulation is effective July
18, 2008. Objections and requests for
hearings must be received on or before
September 16, 2008, 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–2008–0254. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
PO 00000
Frm 00049
Fmt 4700
Sfmt 4700
41283
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:
Karen Samek, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 347–8825; e-mail address:
samek.karen@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:
• 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 an electronic
copy of this Federal Register document
through the electronic docket 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
E:\FR\FM\18JYR1.SGM
18JYR1
41284
Federal Register / Vol. 73, No. 139 / Friday, July 18, 2008 / Rules and Regulations
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
rwilkins on PROD1PC63 with RULES
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, as
amended by FQPA, 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–2008–0254 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 September 16, 2008.
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–2008–0254, 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’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
In the Federal Register of May 16,
2008 (73 FR 28461) (FRL–8361-6), EPA
issued a notice pursuant to section 408
of FFDCA, 21 U.S.C. 346a, as amended
by FQPA (Public Law 104–170),
announcing the filing of a pesticide
VerDate Aug<31>2005
16:19 Jul 17, 2008
Jkt 214001
petition (PP 8E7315) by Rhodia, Inc. c/
o SciReg, Inc., 12733 Director’s Loop,
Woodbridge, Va 22192.. The petition
requested that 40 CFR 180.960 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of oxirane, 2-methyl-, polymer
with oxirane, mono [2-[2-(2butoxymethylethoxy)methylethoxy]
methylethyl] ether; (CAS Reg. No.
926031–36–9). That notice included a
summary of the petition prepared by the
petitioner. There were no comments in
response to the notice of filing.
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing an
exemption from the requirement of a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue * * *.’’ and specifies
factors EPA is to consider in
establishing an exemption.
III. 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.
PO 00000
Frm 00050
Fmt 4700
Sfmt 4700
IV. Risk Assessment and Statutory
Findings
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be shown that the
risks from aggregate exposure to
pesticide chemical residues under
reasonably foreseeable circumstances
will pose no appreciable risks to human
health. In order to determine the risks
from aggregate exposure to pesticide
inert ingredients, the Agency considers
the toxicity of the inert in conjunction
with possible exposure to residues of
the inert ingredient through food,
drinking water, and through other
exposures that occur as a result of
pesticide use in residential settings. If
EPA is able to determine that a finite
tolerance is not necessary to ensure that
there is a reasonable certainty that no
harm will result from aggregate
exposure to the inert ingredient, an
exemption from the requirement of a
tolerance may be established.
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness and reliability and the
relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children. In the
case of certain chemical substances that
are defined as polymers, the Agency has
established a set of criteria to identify
categories of polymers that should
present minimal or no risk. The
definition of a polymer is given in 40
CFR 723.250(b) and the exclusion
criteria for identifying these low-risk
polymers are described in 40 CFR
723.250(d). Oxirane, 2-methyl-, polymer
with oxirane, mono [2-[2-(2butoxymethylethoxy)methylethoxy]
methylethyl] ether conforms to the
definition of a polymer given in 40 CFR
723.250(b) and meets the following
criteria that are used to identify low risk
polymers:
1. The polymer is not a cationic
polymer nor is it reasonably anticipated
to become a cationic polymer in a
natural aquatic environment.
2. The polymer does contain as an
integral part of its composition the
atomic elements carbon, hydrogen, and
oxygen.
3. The polymer does not contain as an
integral part of its composition, except
as impurities, any element other than
those listed in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed
nor can it be reasonably anticipated to
E:\FR\FM\18JYR1.SGM
18JYR1
Federal Register / Vol. 73, No. 139 / Friday, July 18, 2008 / Rules and Regulations
substantially degrade, decompose, or
depolymerize.
5. The polymer is manufactured or
imported from monomers and/or
reactants that are already included on
the TSCA Chemical Substance
Inventory or manufactured under an
applicable TSCA section 5 exemption.
6. The polymer is not a water
absorbing polymer with a number
average molecular weight (MW) greater
than or equal to 10,000 daltons.
Additionally, the polymer also meets
as required the following exemption
criteria specified in 40 CFR 723.250(e).
7. The polymer’s number average MW
of 3,000 daltons is greater than 1,000
and less than 10,000 daltons. The
polymer contains less than 10%
oligomeric material below MW 500 and
less than 25% oligomeric material
below MW 1,000, and the polymer does
not contain any reactive functional
groups.
Thus, oxirane, 2-methyl-, polymer
with oxirane, mono [2-[2-(2butoxymethylethoxy)methylethoxy]
methylethyl] ether meets all the criteria
for a polymer to be considered low risk
under 40 CFR 723.250. Based on its
conformance to the criteria in this unit,
no mammalian toxicity is anticipated
from dietary, inhalation, or dermal
exposure to oxirane, 2-methyl-, polymer
with oxirane, mono [2-[2-(2butoxymethylethoxy)methylethoxy]
methylethyl] ether.
rwilkins on PROD1PC63 with RULES
V. Aggregate Exposures
For the purposes of assessing
potential exposure under this
exemption, EPA considered that
oxirane, 2-methyl-, polymer with
oxirane, mono [2-[2-(2butoxymethylethoxy)methylethoxy]
methylethyl] ether could be present in
all raw and processed agricultural
commodities and drinking water, and
that non-occupational non-dietary
exposure was possible. The number
average MW of oxirane, 2-methyl-,
polymer with oxirane, mono [2-[2-(2butoxymethylethoxy)methylethoxy]
methylethyl] ether is 3,000 daltons.
Generally, a polymer of this size would
be poorly absorbed through the intact
gastrointestinal tract or through intact
human skin. Since oxirane, 2-methyl-,
polymer with oxirane, mono [2-[2-(2butoxymethylethoxy)methylethoxy]
methylethyl] ether conforms to the
criteria that identify a low-risk polymer,
there are no concerns for risks
associated with any potential exposure
scenarios that are reasonably
foreseeable. The Agency has determined
that a tolerance is not necessary to
protect the public health.
VerDate Aug<31>2005
16:19 Jul 17, 2008
Jkt 214001
VI. Cumulative Effects
Section 408 (b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance or tolerance exemption, the
Agency consider ‘‘available
information’’ concerning the cumulative
effects of a particular chemical’s
residues and ‘‘other substances that
have a common mechanism of toxicity.’’
EPA does not have, at this time,
available data to determine whether
oxirane, 2-methyl-, polymer with
oxirane, mono [2-[2-(2butoxymethylethoxy)methylethoxy]
methylethyl] ether has a common
mechanism of toxicity with other
substances. Unlike other pesticides for
which EPA has followed a cumulative
risk approach based on a common
mechanism of toxicity, EPA has not
made a common mechanism of toxicity
finding as to oxirane, 2-methyl-,
polymer with oxirane, mono [2-[2-(2butoxymethylethoxy)methylethoxy]
methylethyl] ether and any other
substances and Oxirane, 2-methyl-,
polymer with oxirane, mono [2-[2-(2butoxymethylethoxy)methylethoxy]
methylethyl] ether does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
not assumed that oxirane, 2-methyl-,
polymer with oxirane, mono [2-[2-(2butoxymethylethoxy)methylethoxy]
methylethyl] ether has a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see the policy statements released by
EPA’s Office of Pesticide Programs
concerning common mechanism
determinations and procedures for
cumulating effects from substances
found to have a common mechanism on
EPA’s Web site at https://www.epa.gov/
pesticides/cumulative.
VII. Additional Safety Factor for the
Protection of Infants and Children
Section 408 of FFDCA provides that
EPA shall apply an additional tenfold
margin of safety for infants and children
in the case of threshold effects to
account for prenatal and postnatal
toxicity and the completeness of the
data base unless EPA concludes that a
different margin of safety will be safe for
infants and children. Due to the
expected low toxicity of oxirane, 2methyl-, polymer with oxirane, mono
[2-[2-(2-butoxymethylethoxy)
methylethoxy]methylethyl] ether, EPA
has not used a safety factor analysis to
PO 00000
Frm 00051
Fmt 4700
Sfmt 4700
41285
assess the risk. For the same reasons the
additional tenfold safety factor is
unnecessary.
VIII. Determination of Safety
Based on the conformance to the
criteria used to identify a low-risk
polymer, EPA concludes that there is a
reasonable certainty of no harm to the
U.S. population, including infants and
children, from aggregate exposure to
residues of oxirane, 2-methyl-, polymer
with oxirane, mono [2-[2-(2butoxymethylethoxy)methylethoxy]
methylethyl] ether.
IX. 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 Tolerances
The Agency is not aware of any
country requiring a tolerance for
oxirane, 2-methyl-, polymer with
oxirane, mono [2-[2-(2butoxymethylethoxy)methylethoxy]
methylethyl] ether nor have any CODEX
Maximum Residue Levels (MRLs) been
established for any food crops at this
time.
X. Conclusion
Accordingly, EPA finds that
exempting residues of oxirane, 2methyl-, polymer with oxirane, mono
[2-[2-(2-butoxymethylethoxy)
methylethoxy]methylethyl] ether from
the requirement of a tolerance will be
safe.
XI. 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 rule has
been exempted from review under
Executive Order 12866, this rule is not
subject to Executive Order 13211,
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
E:\FR\FM\18JYR1.SGM
18JYR1
41286
Federal Register / Vol. 73, No. 139 / Friday, July 18, 2008 / Rules and Regulations
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 rule. In addition, This 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).
XII. Congressional Review Act
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this rule in the Federal
Register. This 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: July 3, 2008.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
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.
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.960 is amended by
adding in alphabetical order a polymer
to the table to read as follows:
I
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
*
*
*
Polymer
CAS No.
*
*
*
*
*
Oxirane, 2-methyl-, polymer with oxirane, mono [2-[2-(2-butoxymethylethoxy)methylethoxy]methylethyl]
ether, minimum number average molecular weight (in amu), 3,000.
*
*
*
[FR Doc. E8–16317 Filed 7–17–08; 8:45 am]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 52 and 64
[CG Docket No. 03–123 and WC Docket No.
05–196; FCC 08–151]
Telecommunications Relay Services
and Speech-to-Speech Services for
Individuals With Hearing and Speech
Disabilities; E911 Requirements for IPEnabled Service Providers
rwilkins on PROD1PC63 with RULES
SUMMARY: In this document, the
Commission adopts a system for
assigning users of Internet-based
Telecommunications Relay Services
(TRS), specifically Video Relay Service
VerDate Aug<31>2005
16:19 Jul 17, 2008
Jkt 214001
*
*
(VRS) and Internet Protocol (IP) Relay,
ten-digit telephone numbers linked to
the North American Numbering Plan
(NANP). This numbering system will
further the TRS functional equivalency
mandate by ensuring that Internet-based
TRS users can be reached by voice
telephone users in the same way that
voice telephone users are called. The
measures the Commission adopts also
are intended to ensure that emergency
calls placed by Internet-based TRS users
will be routed directly and
automatically to the appropriate
emergency services authorities by
Internet-based TRS providers.
Effective August 18, 2008, except
for 47 CFR 64.605 (a) and (b), and
64.611 (a), (b), (c) and (f), which contain
information collection requirements
subject to the Paperwork Reduction Act
(PRA) of 1995, Public law 104–13, that
have not been approved by the Office of
Management and Budget (OMB). The
Commission will publish a separate
DATES:
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
PO 00000
Frm 00052
*
Fmt 4700
Sfmt 4700
*
*
926031–36–9
*
*
document in the Federal Register
announcing the effective date of these
requirements. Interested parties
(including the general public, OMB, and
other Federal agencies) that wish to
submit written comments on the PRA
information collection requirements
must do so on or before September 16,
2008.
ADDRESSES: Interested parties may
submit PRA comments identified by
OMB Control Number 3060–1089, by
any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Federal Communications
Commission’s Web Site: https://
www.fcc.gov/cgb/ecfs/. Follow the
instructions for submitting comments.
• E-mail: Parties who choose to file
by e-mail should submit their comments
to PRA@fcc.gov. Please include CG
Docket Number 03–123, WC Docket
Number 05–196, and OMB Control
E:\FR\FM\18JYR1.SGM
18JYR1
Agencies
[Federal Register Volume 73, Number 139 (Friday, July 18, 2008)]
[Rules and Regulations]
[Pages 41283-41286]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16317]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0254; FRL-8371-7]
Oxirane, 2-methyl-, polymer with oxirane, mono [2-[2-(2-
)butoxymethylethoxy))methylethoxyl] ether; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of oxirane, 2-methyl-, polymer with
oxirane, mono [2-[2-(2-)butoxymethylethoxy)methylethoxy]methylethyl]
ether; (CAS Reg. No. 926031-36-9) when used as an inert ingredient in a
pesticide chemical formulation. Rhodia, Inc. c/o SciReg, Inc.,
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA) requesting an exemption from the requirement of a tolerance.
This regulation eliminates the need to establish a maximum permissible
level for residues of oxirane, 2-methyl-, polymer with oxirane, mono
[2-[2-(2)butoxymethylethoxy))methylethoxy]methylethyl] ether.
DATES: This regulation is effective July 18, 2008. Objections and
requests for hearings must be received on or before September 16, 2008,
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-2008-0254. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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: Karen Samek, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 347-8825; e-mail address: samek.karen@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:
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 an electronic copy of this Federal
Register document through the electronic docket 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
[[Page 41284]]
also access a frequently updated electronic version of 40 CFR part 180
through the Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, as amended by FQPA, 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-2008-0254 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 September 16, 2008.
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-2008-0254, 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'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
In the Federal Register of May 16, 2008 (73 FR 28461) (FRL-8361-6),
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a,
as amended by FQPA (Public Law 104-170), announcing the filing of a
pesticide petition (PP 8E7315) by Rhodia, Inc. c/o SciReg, Inc., 12733
Director's Loop, Woodbridge, Va 22192.. The petition requested that 40
CFR 180.960 be amended by establishing an exemption from the
requirement of a tolerance for residues of oxirane, 2-methyl-, polymer
with oxirane, mono [2-[2-(2-
butoxymethylethoxy)methylethoxy]methylethyl] ether; (CAS Reg. No.
926031-36-9). That notice included a summary of the petition prepared
by the petitioner. There were no comments in response to the notice of
filing.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue * * *.'' and
specifies factors EPA is to consider in establishing an exemption.
III. 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. Risk Assessment and Statutory Findings
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers that should present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). Oxirane, 2-methyl-, polymer with
oxirane, mono [2-[2-(2-butoxymethylethoxy)methylethoxy]methylethyl]
ether conforms to the definition of a polymer given in 40 CFR
723.250(b) and meets the following criteria that are used to identify
low risk polymers:
1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
2. The polymer does contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably
anticipated to
[[Page 41285]]
substantially degrade, decompose, or depolymerize.
5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
7. The polymer's number average MW of 3,000 daltons is greater than
1,000 and less than 10,000 daltons. The polymer contains less than 10%
oligomeric material below MW 500 and less than 25% oligomeric material
below MW 1,000, and the polymer does not contain any reactive
functional groups.
Thus, oxirane, 2-methyl-, polymer with oxirane, mono [2-[2-(2-
butoxymethylethoxy)methylethoxy]methylethyl] ether meets all the
criteria for a polymer to be considered low risk under 40 CFR 723.250.
Based on its conformance to the criteria in this unit, no mammalian
toxicity is anticipated from dietary, inhalation, or dermal exposure to
oxirane, 2-methyl-, polymer with oxirane, mono [2-[2-(2-
butoxymethylethoxy)methylethoxy]methylethyl] ether.
V. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that oxirane, 2-methyl-, polymer with
oxirane, mono [2-[2-(2-butoxymethylethoxy)methylethoxy]methylethyl]
ether could be present in all raw and processed agricultural
commodities and drinking water, and that non-occupational non-dietary
exposure was possible. The number average MW of oxirane, 2-methyl-,
polymer with oxirane, mono [2-[2-(2-
butoxymethylethoxy)methylethoxy]methylethyl] ether is 3,000 daltons.
Generally, a polymer of this size would be poorly absorbed through the
intact gastrointestinal tract or through intact human skin. Since
oxirane, 2-methyl-, polymer with oxirane, mono [2-[2-(2-
butoxymethylethoxy)methylethoxy]methylethyl] ether conforms to the
criteria that identify a low-risk polymer, there are no concerns for
risks associated with any potential exposure scenarios that are
reasonably foreseeable. The Agency has determined that a tolerance is
not necessary to protect the public health.
VI. Cumulative Effects
Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance or tolerance
exemption, the Agency consider ``available information'' concerning the
cumulative effects of a particular chemical's residues and ``other
substances that have a common mechanism of toxicity.'' EPA does not
have, at this time, available data to determine whether oxirane, 2-
methyl-, polymer with oxirane, mono [2-[2-(2-
butoxymethylethoxy)methylethoxy]methylethyl] ether has a common
mechanism of toxicity with other substances. Unlike other pesticides
for which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding as to oxirane, 2-methyl-, polymer with oxirane, mono [2-[2-(2-
butoxymethylethoxy)methylethoxy]methylethyl] ether and any other
substances and Oxirane, 2-methyl-, polymer with oxirane, mono [2-[2-(2-
butoxymethylethoxy)methylethoxy]methylethyl] ether does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has not assumed that
oxirane, 2-methyl-, polymer with oxirane, mono [2-[2-(2-
butoxymethylethoxy)methylethoxy]methylethyl] ether has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's Web site at https://www.epa.gov/pesticides/cumulative.
VII. Additional Safety Factor for the Protection of Infants and
Children
Section 408 of FFDCA provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base unless EPA concludes that a different
margin of safety will be safe for infants and children. Due to the
expected low toxicity of oxirane, 2-methyl-, polymer with oxirane, mono
[2-[2-(2-butoxymethylethoxy)methylethoxy]methylethyl] ether, EPA has
not used a safety factor analysis to assess the risk. For the same
reasons the additional tenfold safety factor is unnecessary.
VIII. Determination of Safety
Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of oxirane, 2-methyl-, polymer with
oxirane, mono [2-[2-(2-butoxymethylethoxy)methylethoxy]methylethyl]
ether.
IX. 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 Tolerances
The Agency is not aware of any country requiring a tolerance for
oxirane, 2-methyl-, polymer with oxirane, mono [2-[2-(2-
butoxymethylethoxy)methylethoxy]methylethyl] ether nor have any CODEX
Maximum Residue Levels (MRLs) been established for any food crops at
this time.
X. Conclusion
Accordingly, EPA finds that exempting residues of oxirane, 2-
methyl-, polymer with oxirane, mono [2-[2-(2-
butoxymethylethoxy)methylethoxy]methylethyl] ether from the requirement
of a tolerance will be safe.
XI. 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, 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
[[Page 41286]]
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 rule. In addition, This
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).
XII. 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 rule in the Federal
Register. This 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: July 3, 2008.
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.
0
2. Section 180.960 is amended by adding in alphabetical order a polymer
to the table to read as follows:
Sec. 180.960 Polymers; exemptions from the requirement of a
tolerance.
* * * * *
------------------------------------------------------------------------
Polymer CAS No.
------------------------------------------------------------------------
* * * * * * *
Oxirane, 2-methyl-, polymer with 926031-36-9
oxirane, mono [2-[2-(2-
butoxymethylethoxy)methylethoxy]met
hylethyl] ether, minimum number
average molecular weight (in amu),
3,000.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. E8-16317 Filed 7-17-08; 8:45 am]
BILLING CODE 6560-50-S