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Federal Register / Vol. 71, No.

143 / Wednesday, July 26, 2006 / Rules and Regulations 42285

‘‘major rule’’ as defined by 5 U.S.C. Quality Protection Act of 1996 (FQPA) for readers regarding entities likely to be
804(2). requesting an exemption from the affected by this action. Other types of
requirement of a tolerance. This entities not listed in this unit could also
List of Subjects in 40 CFR Part 180
regulation eliminates the need to be affected. The North American
Environmental protection, establish a maximum permissible level Industrial Classification System
Administrative practice and procedure, for residues of oxirane, methyl-, (NAICS) codes have been provided to
Agricultural commodities, Pesticides polymer with oxirane, monobutyl ether. assist you and others in determining
and pests, Reporting and recordkeeping DATES: This regulation is effective July whether this action might apply to
requirements. 26, 2006. Objections and requests for certain entities. If you have any
hearings must be received on or before questions regarding the applicability of
Dated: July 17, 2006. this action to a particular entity, consult
September 25, 2006, and must be filed
Lois Rossi, the person listed under FOR FURTHER
in accordance with the instructions
Director, Registration Division, Office of provided in 40 CFR part 178 (see also INFORMATION CONTACT.
Pesticide Programs.
Unit I.C. of the SUPPLEMENTARY B. How Can I Access Electronic Copies
■Therefore, 40 CFR part 180 is INFORMATION). of this Document?
amended as follows:
ADDRESSES: EPA has established a In addition to accessing an electronic
PART 180—[AMENDED] docket for this action under docket copy of this Federal Register document
identification (ID) number EPA–HQ– through the electronic docket at http://
■ 1. The authority citation for part 180 OPP–2006–0588. All documents in the www.regulations.gov, you may access
continues to read as follows: docket are listed in the index for the this ‘‘Federal Register’’ document
Authority: 21 U.S.C. 321(q), 346a and 371. docket. Although listed in the index, electronically through the EPA Internet
■ 2. In § 180.960, the table is amended some information is not publicly under the ‘‘ Federal Register ’’ listings
by adding alphabetically a polymer to available, e.g., Confidential athttp://www.epa.gov/fedrgstr. You may
read as follows: BusinessInformation (CBI) or other also access a frequently updated
information whose disclosure is electronic version of 40 CFR part 180
§ 180.960 Polymers; exemptions from the restricted by statute. Certain other through the Government Printing
requirement of a tolerance. material, such as copyrighted material, Office’s pilot e-CFR site at http://
* * * * * is not placed on the Internet and will be www.gpoaccess.gov/ecfr.
publicly available only in hard copy
form. Publicly available docket C. Can I File an Objection or Hearing
Polymer CAS No. Request?
materials are available in the electronic
* * * * * docketat http://www.regulations.gov, or, Under section 408(g) of the FFDCA, as
if only availablein hard copy, at the OPP amended by the FQPA, any person may
2-Propenoic, 2-methyl-, poly- 888969–14–0 Regulatory Public Docket in Rm. S-4400, file an objection to any aspect of this
mers with ethyl acrylate One Potomac Yard (South Building), regulation and may also request a
and polyethylene glycol 2777 S. Crystal Drive, Arlington, VA. hearing on those objections. The EPA
methylacrylate C18-22 alkyl
The Docket Facility is open from 8:30 procedural regulations which govern the
ethers
* * * * * a.m. to 4 p.m., Monday through Friday, submission of objections and requests
excluding legal holidays. The Docket for hearings appear in 40 CFR part 178.
telephone number is (703) 305–5805. You must file your objection or request
[FR Doc. E6–11824 Filed 7–25–06; 8:45 am] FOR FURTHER INFORMATION CONTACT: a hearing on this regulation in
BILLING CODE 6560–50–S Bipin Gandhi, Registration Division accordance with the instructions
(7505P), Office of Pesticide Programs, provided in 40 CFR part 178. To ensure
Environmental Protection Agency, 1200 proper receipt by EPA, you must
ENVIRONMENTAL PROTECTION Pennsylvania Ave., NW., Washington, identify docket ID number EPA–HQ–
AGENCY DC 20460–0001; telephone number: OPP–2006–0588 in the subject line on
(703) 308–8380; e-mail the first page of your submission. All
40 CFR Part 180 address:gandhi.bipin@epa.gov. requests must be in writing, and must be
[EPA–HQ–OPP–2006–0588; FRL–8078–4] mailed or delivered to the Hearing Clerk
SUPPLEMENTARY INFORMATION:
on or before September 25, 2006.
Oxirane, Methyl-, Polymer with I. General Information In addition to filing an objection or
Oxirane, Monobutyl Ether; Tolerance hearing request with the Hearing Clerk
A. Does this Action Apply to Me? as described in 40 CFR part 178, please
Exemption
You may be potentially affected by submit a copy of the filing that does not
AGENCY: Environmental Protection this action if you are an agricultural contain any CBI for inclusion in the
Agency (EPA). producer, food manufacturer, or public docket that is described in
ACTION: Final rule. pesticide manufacturer. Potentially ADDRESSES. Information not marked
affected entities may include, but are confidential pursuant to 40 CFR part 2
SUMMARY: This regulation establishes an not limited to: may be disclosed publicly by EPA
exemption from the requirement of a • Crop production (NAICS code 111) without prior notice. Submit your
tolerance for residues of oxirane, • Animal production (NAICS code copies, identified by docket ID number
methyl-, polymer with oxirane, 112) EPA–HQ–OPP–2006–0588, by one of
monobutyl ether; when used as an inert • Food manufacturing (NAICS code the following methods.
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ingredient in a pesticide chemical 311) • Federal eRulemaking Portal:http://


formulation. BASF Corporation, • Pesticide manufacturing (NAICS www.regulations.gov. Follow the on-line
submitted a petition to EPA under the code 32532) instructions for submitting comments.
Federal Food, Drug, and Cosmetic Act This listing is not intended to be • Mail: Office of Pesticide Programs
(FFDCA), as amended by the Food exhaustive, but rather provides a guide (OPP) Regulatory Public Docket (7502P),

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42286 Federal Register / Vol. 71, No. 143 / Wednesday, July 26, 2006 / Rules and Regulations

Environmental Protection Agency, 1200 III. Inert Ingredient Definition CFR 723.250(b). The following
Pennsylvania Ave., NW., Washington, Inert ingredients are all ingredients exclusion criteria for identifying these
DC 20460–0001. that are not active ingredients as defined low risk polymers are described in 40
• Delivery: OPP Regulatory Public in 40 CFR 153.125 and include, but are CFR 723.250(d).
Docket (7502P), Environmental not limited to, the following types of 1. The polymer, oxirane, methyl-,
Protection Agency, Rm. S-4400, One ingredients (except when they have a polymer with oxirane, monobutyl ether,
Potomac Yard (South Building), 2777 S. pesticidal efficacy of their own): is not a cationic polymer nor is it
Solvents such as alcohols and reasonably anticipated to become a
Crystal Drive, Arlington, VA. Deliveries
hydrocarbons; surfactants such as cationic polymer in a natural aquatic
are only accepted during the Docket’s
polyoxyethylene polymers and fatty environment.
normal hours of operation (8:30 a.m. to
2. The polymer, oxirane, methyl-,
4 p.m., Mondaythrough Friday, acids; carriers such as clay and
polymer with oxirane, monobutyl ether,
excluding legal holidays). Special diatomaceous earth; thickeners such as
does contain as an integral part of its
arrangements should be made for carrageenan and modified cellulose;
composition the atomic elements
deliveries of boxed information. The wetting, spreading, and dispersing
carbon, hydrogen, and oxygen.
Docket telephone number is (703) 305– agents; propellants in aerosol 3. The polymer, oxirane, methyl-,
5805. dispensers; microencapsulating agents; polymer with oxirane, monobutyl ether,
and emulsifiers. The term ‘‘inert’’ is not does not contain as an integral part of
II. Background and Statutory Findings intended to imply nontoxicity; the its composition, except as impurities,
In the Federal Register of June 1, 2005 ingredient may or may not be any element other than those listed in
(70 FR 31453) (FRL–7711–2), EPA chemicallyactive. Generally, EPA has 40 CFR 723.250(d)(2)(ii).
issued a notice pursuant to section 408 exempted inert ingredients from the 4. The polymer, oxirane, methyl-,
of the FFDCA, 21 U.S.C. 346a, as requirement of a tolerance based on the polymer with oxirane, monobutyl ether,
amended by the FQPA (Public Law 104– low toxicity of the individual inert is neither designed nor can it be
ingredients. reasonably anticipated to substantially
170), announcing the filing of a
pesticide petition (PP 5E6917) by BASF IV. Risk Assessment and Statutory degrade, decompose, or depolymerize.
Corporation, 100 Campus Drive, Findings 5. The polymer, oxirane, methyl-,
Florham Park, NJ 07932. The petition polymer with oxirane, monobutyl ether,
EPA establishes exemptions from the is manufactured or imported from
requested that 40CFR 180.960 be requirement of a tolerance only in those
amended by establishing an exemption monomers and/or reactants that are
cases where it can be shown that the already included on the TSCA Chemical
from the requirement of a tolerance for risks from aggregate exposure to
residues of oxirane, methyl-, polymer Substance Inventory or manufactured
pesticide chemical residues under under an applicable TSCA section 5
with oxirane, monobutyl ether; CAS reasonably foreseeable circumstances
Reg. No. 9038–95–3. That notice exemption.
will pose no appreciable risks to human 6. The polymer, oxirane, methyl-,
included a summary of the petition health. In order to determine the risks
prepared by the petitioner. There were polymer with oxirane, monobutyl ether,
from aggregate exposure to pesticide is not a water absorbing polymer with
no comments in response to the notice inert ingredients, the Agency
of filing. a number average molecular weight
considersthe toxicity of the inert in (MW) greater than or equal to 10,000
Section 408(c)(2)(A)(i) of the FFDCA conjunction with possible exposure to daltons.
allows EPA to establish an exemption residues of the inert ingredient through Additionally, the polymer, oxirane,
from the requirement for a tolerance (the food, drinking water, and through other methyl-, polymer with oxirane,
legal limit for a pesticide chemical exposures that occur as a result of monobutyl ether, also meets as required
residue in or on a food) only if EPA pesticide use in residential settings. If the following exemption criteria
determines that the tolerance is‘‘safe.’’ EPA is able to determine that a finite specified in 40 CFR 723.250(e).
Section 408(c)(2)(A)(ii) of the FFDCA tolerance is not necessary to ensure that 7. The polymer’s number average MW
defines‘‘safe’’ to mean that ‘‘there is a there is a reasonable certainty that no of 4,000 is greater than 1,000 and less
reasonable certainty that no harm will harm will result from aggregate than 10,000 daltons. The polymer
result from aggregate exposure to the exposure to the inert ingredient, an contains less than 10% oligomeric
pesticide chemical residue, including exemption from the requirement of a material below MW 500 and less than
all anticipated dietary exposures and all tolerance may be established. 25% oligomeric material below MW
other exposures forwhich there is Consistent with section 408(b)(2)(D) 1,000, and the polymer does not contain
reliable information.’’ This includes of the FFDCA, EPA has reviewed the any reactive functional groups.
exposure through drinking water and in available scientific data and other Thus, oxirane, methyl-, polymer with
residential settings, but does not include relevant information in support of this oxirane, monobutyl ether meet all the
occupational exposure. Section action and considered its validity, criteria for a polymer to be considered
408(b)(2)(C) of the FFDCA requires EPA completeness and reliability and the low risk under 40 CFR 723.250. Based
to give special consideration to relationship of this information to on its conformance to the above criteria,
exposure of infants and children to the human risk. EPA has also considered no mammalian toxicity is anticipated
pesticide chemical residue in available information concerning the from dietary, inhalation, or dermal
establishing an exemption from the variability of the sensitivities of major exposure to oxirane, methyl-, polymer
requirement of a tolerance and to identifiable subgroups of consumers, with oxirane, monobutyl ether.
‘‘ensure that there is a reasonable including infants and children. In the
certainty that no harm will result to case of certain chemical substances that V. Aggregate Exposures
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infants and children from aggregate are defined as polymers, the Agency has For the purposes of assessing
exposure to the pesticide chemical established a set of criteria to identify potential exposure under this
residue...’’ and specifies factors EPA is categories of polymers that should exemption, EPA considered that
to consider in establishing an present minimal or no risk. The oxirane, methyl-, polymer with oxirane,
exemption. definition of a polymer is given in 40 monobutyl ether could be present in all

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Federal Register / Vol. 71, No. 143 / Wednesday, July 26, 2006 / Rules and Regulations 42287

raw and processed agricultural children in the case of threshold effects Order 13211, Actions Concerning
commodities and drinking water, and to account for prenatal and postnatal Regulations That Significantly Affect
that non-occupational non-dietary toxicity and the completeness of the Energy Supply, Distribution, or Use (66
exposure was possible. The number data base unless EPA concludes that a FR 28355, May 22, 2001). This final rule
average MW of oxirane, methyl-, different margin of safety will be safe for does not contain any information
polymer with oxirane, monobutyl ether infants and children. Due to the collections subject to OMB approval
is 4,000 daltons. Generally, a polymer of expected low toxicity of oxirane, under the Paperwork Reduction Act
this size would be poorly absorbed methyl-, polymer with oxirane, (PRA), 44 U.S.C. 3501 et seq., or impose
through the intact gastrointestinal tract monobutyl ether, EPA has not used a any enforceable duty or contain any
or through intact human skin. Since safety factor analysis to assess the risk. unfunded mandate as described under
oxirane, methyl-, polymer with oxirane, For the same reasons the additional Title II of the Unfunded Mandates
monobutyl ether conform to the criteria tenfold safety factor is unnecessary. Reform Act of 1995 (UMRA) (Public
thatidentify a low risk polymer, there Law 104–4). Nor does it require any
VIII. Determination of Safety
are no concerns for risks associated with special considerations under Executive
any potential exposure scenarios that Based on the conformance to the Order 12898, entitled Federal Actions to
are reasonably foreseeable. The Agency criteria used to identify a low risk Address Environmental Justice in
has determined that a tolerance is not polymer, EPA concludes that there is a Minority Populations and Low-Income
necessary to protect the public health. reasonable certainty of no harm to the Populations (59 FR 7629, February 16,
U.S. population, including infants and
VI. Cumulative Effects 1994); or OMB review or any Agency
children, from aggregate exposure to
Section 408 (b)(2)(D)(v) of FFDCA action under Executive Order 13045,
residues of oxirane, methyl-, polymer
requires that, when considering whether entitled Protection of Children from
with oxirane, monobutyl ether.
to establish, modify, or revoke a Environmental Health Risks and Safety
tolerance or tolerance exemption, the IX. Other Considerations Risks (62 FR 19885, April 23, 1997).
Agency consider ‘‘available This action does not involve any
A. Endocrine Disruptors
information’’ concerning the cumulative technical standards that would require
There is no available evidence that Agency consideration of voluntary
effects of a particular chemical’s oxirane, methyl-, polymer with oxirane,
residues and ‘‘other substances that consensus standards pursuant to section
monobutyl ether is an endocrine 12(d) of the National Technology
have a common mechanism of toxicity.’’ disruptor.
EPA does not have, at this time, Transfer and Advancement Act of 1995
available data to determine whether B. Analytical Enforcement Methodology (NTTAA), Public Law 104–113, section
oxirane, methyl-, polymer with oxirane, 12(d) (15 U.S.C. 272 note). Since
An analytical method is not required tolerances and exemptions that are
monobutyl ether has a common for enforcement purposes since the
mechanism of toxicity with other established on the basis of a petition
Agency is establishing an exemption under section 408(d) of the FFDCA,
substances. Unlike other pesticides for from the requirement of a tolerance
which EPA has followed a cumulative such as the exemption in this final rule,
without any numerical limitation. do not require the issuance of a
risk approachbased on a common
mechanism of toxicity, EPA has not C. International Tolerances proposed rule, the requirements of the
made a common mechanism of toxicity The Agency is not aware of any Regulatory Flexibility Act (RFA) (5
finding as to oxirane, methyl-, polymer country requiring a tolerance for U.S.C. 601 et seq.) do not apply. In
with oxirane, monobutyl ether and any oxirane, methyl-, polymer with oxirane, addition, the Agency has determined
other substances and oxirane, methyl-, monobutyl ether nor have any CODEX that this action will not have a
polymer with oxirane, monobutyl ether Maximum Residue Levels (MRLs) been substantial direct effect on States, on the
does not appear to produce a toxic established for any food crops at this relationship between the national
metabolite produced by other time. government and the States, or on the
substances. For the purposes of this distribution of power and
tolerance action, therefore, EPA has not X. Conclusion responsibilities among the various
assumed that oxirane, methyl-, polymer Accordingly, EPA finds that levels of government, as specified in
with oxirane, monobutyl ether has a exempting residues of oxirane, Executive Order 13132, entitled
common mechanism of toxicity with methyl-, polymer with oxirane, Federalism (64 FR 43255, August 10,
other substances. For information monobutyl ether from the requirement 1999). Executive Order 13132 requires
regarding EPA’s efforts to determine of a tolerance will be safe. EPA to develop an accountable process
which chemicals have a common to ensure ‘‘meaningful and timely input
XI. Statutory and Executive Order by State and local officials in the
mechanism of toxicity and to evaluate
Reviews development of regulatory policies that
the cumulative effects of such
chemicals, see the policy statements This final rule establishes an have federalism implications. ’’
released by EPA’s Office of Pesticide exemption from the tolerance ‘‘Policies that have federalism
Programs concerning common requirement under section 408(d) of the implications’’ is defined in the
mechanism determinations and FFDCA in response to a petition Executive order to include regulations
procedures for cumulating effects from submitted to the Agency. The Office of that have‘‘substantial direct effects on
substances found to have a common Management and Budget (OMB) has the States, on the relationship between
mechanism on EPA’s website athttp:// exempted these types of actions from the national government and the States,
www.epa.gov/pesticides/cumulative. review under Executive Order 12866, or on the distribution of power and
entitled Regulatory Planning and responsibilities among the various
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VII. Additional Safety Factor for the Review (58 FR 51735, October 4, 1993). levels of government.’’ This final rule
Protection of Infants and Children Because this rule has been exempted directly regulates growers, food
Section 408 of the FFDCA provides from review under Executive Order processors, food handlers and
that EPA shall apply an additional 12866 due to its lack of significance, foodretailers, not States. This action
tenfold margin of safety for infants and this rule is not subject to Executive does not alter the relationships or

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42288 Federal Register / Vol. 71, No. 143 / Wednesday, July 26, 2006 / Rules and Regulations

distribution of power and PART 180—AMENDED identification (ID) number EPA–HQ–


responsibilities established by Congress OPP–2006–0551. All documents in the
in the preemption provisions of section ■ 1. The authority citation for part 180 docket are listed in the index for the
408(n)(4) of the FFDCA. For these same continues to read as follows: docket. Although listed in the index,
reasons, the Agency has determined that Authority: 21 U.S.C. 321(q), 346a and 371. some information is not publicly
this rule does not have any ‘‘tribal ■ 2. Section 180.960 is amended in the available, e.g., Confidential Business
implications’’ as described in Executive table by removing the entry for ‘‘a- Information (CBI) or other information
Order 13175, entitled Consultation and Butyl-w-hydroxypoly(oxypropylene) whose disclosure is restricted by statute.
Coordination with Indian Tribal block polymer with poly(oxyethylene); Certain other material, such as
Governments (65 FR 67249, November molecular weight (in amu) 2,400— copyrighted material, is not placed on
6, 2000). Executive Order 13175, 3,500’’ and by alphabetically adding a the Internet and will be publicly
requires EPA to develop an accountable polymer to read as follows: available only in hard copy form.
process to ensure ‘‘meaningful and Publicly available docket materials are
timely input by tribal officials in the § 180.960 Polymers; exemptions from the
requirement of a tolerance. available in the electronic docket at
development of regulatorypolicies that http://www.regulations.gov, or, if only
have tribal implications.’’ ‘‘Policies that * * * * *
available in hard copy, at the OPP
have tribal implications’’ is defined in Regulatory Public Docket in Rm. S–
the Executive order to include Polymer CAS No.
4400, One Potomac Yard (South
regulations that have ‘‘substantial direct * * * * * Building), 2777 S. Crystal Drive,
effects on one or more Indian tribes, on Arlington, VA. The Docket Facility is
the relationship between the Federal Oxirane, methyl-, polymer with open from 8:30 a.m. to 4 p.m., Monday
Government and the Indian tribes, or on Oxirane, Monobutyl Ether 9038–95–3 through Friday, excluding legal
the distribution of power and * * * * *
holidays. The Docket telephone number
responsibilities between the Federal
is (703) 305–5805.
Government and Indian tribes.’’ This
rule will not have substantial direct [FR Doc. E6–11952 Filed 7–25–06; 8:45 am] FOR FURTHER INFORMATION CONTACT:
effects on tribal governments, on the BILLING CODE 6560–50–S Bipin Gandhi, Registration Division
relationship between the Federal (7505P), Office of Pesticide Programs,
Government and Indian tribes, or on the Environmental Protection Agency, 1200
distribution of power and ENVIRONMENTAL PROTECTION Pennsylvania Ave., NW., Washington,
responsibilities between the Federal AGENCY DC 20460–0001; telephone number:
Government and Indian tribes, as (703) 308–8380; e-mail address:
40 CFR Part 180
specified in Executive Order 13175. gandhi.bipin@epa.gov.
Thus, Executive Order 13175 does not [EPA–HQ–OPP–2006–0551; FRL–8075–7]
apply to this rule. SUPPLEMENTARY INFORMATION:
2H-Azepin-2-one, 1-Ethenylhexahydro-,
XII. Congressional Review Act Homopolymer I; Tolerance Exemption I. General Information
The Congressional Review Act, 5 AGENCY: Environmental Protection A. Does this Action Apply to Me?
U.S.C. 801 et seq., as added by the Small Agency (EPA).
Business Regulatory Enforcement You may be potentially affected by
ACTION: Final rule.
Fairness Act of 1996, generally provides this action if you are an agricultural
that before a rule may take effect, the SUMMARY: This regulation establishes an producer, food manufacturer, or
agency promulgating the rule must exemption from the requirement of a pesticide manufacturer. Potentially
submit a rule report, which includes a tolerance for residues of 2H-azepin-2- affected entities may include, but are
copy of the rule, to each House of the one, 1-ethenylhexahydro-, not limited to:
Congress and to the Comptroller General homopolymer; when used as an inert • Crop production (NAICS code 111)
of the United States. EPA will submit a ingredient in a pesticide chemical
report containing this rule and other • Animal production (NAICS code
formulation BASF AG submitted a
required information to the U.S. Senate, petition to EPA under the Federal Food, 112)
the U.S. House of Representatives, and Drug, and Cosmetic Act (FFDCA), as • Food manufacturing (NAICS code
the Comptroller General of the United amended by the Food Quality Protection 311)
States prior to publication of this rule in Act of 1996 (FQPA) requesting an • Pesticide manufacturing (NAICS
the Federal Register. This rule is not a exemption from the requirement of a code 32532)
‘‘major rule ’’ as defined by 5 U.S.C. tolerance. This regulation eliminates the
804(2). need to establish a maximum This listing is not intended to be
permissible level for residues of 2H- exhaustive, but rather provides a guide
List of Subjects in 40 CFR Part 180 for readers regarding entities likely to be
azepin-2-one, 1-ethenylhexahydro-,
Environmental protection, homopolymer. affected by this action. Other types of
Administrative practice and procedure, entities not listed in this unit could also
DATES: This regulation is effective July be affected. The North American
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping 26, 2006. Objections and requests for Industrial Classification System
requirements. hearings must be received on or before (NAICS) codes have been provided to
September 25, 2006, and must be filed assist you and others in determining
Dated: July 17, 2006. in accordance with the instructions whether this action might apply to
rwilkins on PROD1PC63 with RULES_1

Lois Rossi, provided in 40 CFR part 178 (see also certain entities. If you have any
Director, Registration Division, Office of Unit I.C. of the SUPPLEMENTARY questions regarding the applicability of
Pesticide Programs. INFORMATION). this action to a particular entity, consult
■Therefore, 40 CFR chapter I is ADDRESSES: EPA has established a the person listed under FOR FURTHER
amended as follows: docket for this action under docket INFORMATION CONTACT.

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