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Federal Register / Vol. 72, No.

167 / Wednesday, August 29, 2007 / Proposed Rules 49689

Dated: August 16, 2007. deliveries of boxed information. The The hours of operation of this Docket
J.I. Palmer, Jr., Docket telephone number is (703) 305– Facility are from 8:30 a.m. to 4 p.m.,
Regional Administrator, Region 4. 5805. Monday through Friday, excluding legal
[FR Doc. E7–17133 Filed 8–28–07; 8:45 am] Instructions: Direct your comments to holidays. The Docket telephone number
BILLING CODE 6560–50–P
docket ID number EPA–HQ–OPP–2007– is (703) 305-5805.
0182. EPA’s policy is that all comments FOR FURTHER INFORMATION CONTACT:
received will be included in the docket Tracy Ward, Registration Division
ENVIRONMENTAL PROTECTION without change and may be made (7505P), Office of Pesticide Programs,
AGENCY available on-line at http:// Environmental Protection Agency, 1200
www.regulations.gov, including any Pennsylvania Ave, NW., Washington,
40 CFR Part 180 personal information provided, unless DC 20460-0001; telephone number:
the comment includes information (703) 308–9361; e-mail address:
[EPA–HQ–OPP–2007–0182; FRL–8143–3] claimed to be Confidential Business ward.tracyh@epa.gov.
Information (CBI) or other information
Dibasic Esters (CAS Reg. No. 95481– SUPPLEMENTARY INFORMATION:
whose disclosure is restricted by statute.
62–2); Proposed Pesticide Tolerance
Do not submit information that you I. General Information
Exemption
consider to be CBI or otherwise
AGENCY: Environmental Protection protected through regulations.gov or e- A. Does this Action Apply to Me?
Agency (EPA). mail. The Federal regulations.gov You may be potentially affected by
ACTION: Proposed rule. website is an ‘‘anonymous access’’ this action if you are an agricultural
system, which means EPA will not producer, food manufacturer, or
SUMMARY: This document proposes to know your identity or contact pesticide manufacturer. Potentially
establish an exemption from the information unless you provide it in the affected entities may include, but are
requirement of a tolerance for residues body of your comment. If you send an not limited to:
of dibasic esters (DBE; CAS Reg. No. e-mail comment directly to EPA without • Crop production (NAICS code 111).
95481–62–2) under 40 CFR 180.1277 going through regulations.gov, your e- • Animal production (NAICS code
when used as an inert ingredient solvent mail address will be automatically 112).
material/anti-freeze microencapsulated captured and included as part of the • Food manufacturing (NAICS code
at 10% weight/weight (W/W) or less in comment that is placed in the docket 311).
pesticide formulations with the active and made available on the Internet. If • Pesticide manufacturing (NAICS
ingredient cyfluthrin. Whitmire Micro- you submit an electronic comment, EPA code 32532).
Gen Research Laboratories, Inc. recommends that you include your This listing is not intended to be
submitted a petition to EPA under the name and other contact information in exhaustive, but rather provides a guide
Federal Food, Drug, and Cosmetic Act the body of your comment and with any for readers regarding entities likely to be
(FFDCA), as amended by the Food disk or CD-ROM you submit. If EPA affected by this action. Other types of
Quality Protection Act of 1996 (FQPA), cannot read your comment due to entities not listed in this unit could also
requesting an exemption from the technical difficulties and cannot contact be affected. The North American
requirement of a tolerance. New data you for clarification, EPA may not be Industrial Classification System
were received by EPA after the able to consider your comment. (NAICS) codes have been provided to
publication of the petitoner’s Notice of Electronic files should avoid the use of assist you and others in determining
Filing, therefore, EPA is providing the special characters, any form of whether this action might apply to
public with an additional opportunity to encryption, and be free of any defects or certain entities. To determine whether
comment on the petitioner’s request in viruses. you or your business may be affected by
this proposed rule. Docket: All documents in the docket this action, you should carefully
are listed in the docket index available examine the applicability provisions in
DATES: Comments must be received on Unit II. If you have any questions
in regulations.gov. To access the
or before October 29, 2007. electronic docket, go to http:// regarding the applicability of this action
ADDRESSES: Submit your comments, www.regulations.gov, select ‘‘Advanced to a particular entity, consult the person
identified by docket identification (ID) Search,’’ then ‘‘Docket Search.’’ Insert listed under FOR FURTHER INFORMATION
number EPA–HQ–OPP–2007–0182, by the docket ID number where indicated CONTACT.
one of the following methods: and select the ‘‘Submit’’ button. Follow
• Federal eRulemaking Portal: http:// B. What Should I Consider as I Prepare
the instructions on the regulations.gov
www.regulations.gov. Follow the on-line My Comments for EPA?
web site to view the docket index or
instructions for submitting comments. access available documents. Although 1. Submitting CBI. Do not submit this
• Mail: Office of Pesticide Programs listed in the index, some information is information to EPA through
(OPP) Regulatory Public Docket (7502P), not publicly available, e.g., CBI or other regulations.gov or e-mail. Clearly mark
Environmental Protection Agency, 1200 information whose disclosure is the part or all of the information that
Pennsylvania Ave., NW., Washington, restricted by statute. Certain other you claim to be CBI. For CBI
DC 20460–0001. material, such as copyrighted material, information in a disk or CD ROM that
• Delivery: OPP Regulatory Public is not placed on the Internet and will be you mail to EPA, mark the outside of the
Docket (7502P), Environmental publicly available only in hard copy disk or CD ROM as CBI and then
Protection Agency, Rm. S-4400, One form. Publicly available docket identify electronically within the disk or
Potomac Yard (South Building), 2777 S. materials are available either in the CD ROM the specific information that is
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Crystal Drive, Arlington, VA. Deliveries electronic docket at http:// claimed as CBI. In addition to one
are only accepted during the Docket’s www.regulations.gov, or, if only complete version of the comment that
normal hours of operation (8:30 a.m. to available in hard copy, at the OPP includes information claimed as CBI, a
4 p.m., Monday through Friday, Regulatory Public Docket in Rm. S-4400, copy of the comment that does not
excluding legal holidays). Special One Potomac Yard (South Building), contain the information claimed as CBI
arrangements should be made for 2777 S. Crystal Drive, Arlington, VA. must be submitted for inclusion in the

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49690 Federal Register / Vol. 72, No. 167 / Wednesday, August 29, 2007 / Proposed Rules

public docket. Information so marked August 5, 1999 (64 FR 42692)] in which available information concerning the
will not be disclosed except in the Agency issued a testing consent variability of the sensitivities of major
accordance with procedures set forth in order incorporating an enforceable identifiable subgroups of consumers,
40 CFR part 2. consent agreement (ECA) under section including infants and children. The
2. Tips for preparing your comments. 4 of the Toxic Substance Control Act nature of the toxic effects caused by the
When submitting comments, remember (TSCA). EPA reviewed the new data [see dibasic esters (DBE) are discussed in
to: the Federal Register of August 17, 2005 this unit. EPA has sufficient data to
i. Identify the document by docket ID (70 FR 48418)] and considered the study assess the hazards of, and to make a
number and other identifying results in evaluating this petition. The determination on, aggregate exposure
information (subject heading, Federal Agency and the U.S. Consumer Product for this chemical.
Register date and page number). Safety Commission (CPSC) agreed that
ii. Follow directions. The Agency may all testing requirements were The following provides a brief
ask you to respond to specific questions completed, and that a third testing summary of the risk assessment and
or organize comments by referencing a phase (in vivo dermal penetration rate conclusions for the Agency’s review of
Code of Federal Regulations (CFR) part testing) was unnecessary. Considering DBE. The full decision document for
or section number. this new data were not part of the this action is available on EPA’s
iii. Explain why you agree or disagree; December 23, 1998 Notice of Filing, Electronic Docket at http://
suggest alternatives and substitute EPA is providing the public with an www.regulations.gov/ under docket
language for your requested changes. additional opportunity to comment on number EPA–HQ–OPP–2007–0182.
iv. Describe any assumptions and the petitioner’s request to establish a
provide any technical information and/ A. Human Health
tolerance exemption for DBE by
or data that you used. proposing to establish a tolerance The Agency reviewed the information
v. If you estimate potential costs or exemption for DBE in this document. submitted by the petitioner as well as
burdens, explain how you arrived at Section 408(b)(2)(A)(i) of the FFDCA additional information available to the
your estimate in sufficient detail to allows EPA to establish an exemption Agency and has determined that DBE
allow for it to be reproduced. from the requirement of a tolerance (the has low acute oral and inhalation
vi. Provide specific examples to legal limit for a pesticide chemical
illustrate your concerns and suggest toxicity and low subchronic oral
residue in or on a food) only if EPA
alternatives. toxicity with a no observed adverse
determines that the tolerance is ‘‘safe.’’
vii. Explain your views as clearly as effect level (NOAEL) of 842 mg/kg/day.
Section 408(b)(2)(A)(ii) of the FFDCA
possible, avoiding the use of profanity In acute eye toxicity studies on the
defines ‘‘safe’’ to mean that ‘‘ there is a
or personal threats. reasonable certainty that no harm will rabbit, DBE had mild to moderate eye
viii. Make sure to submit your result from aggregate exposure to the irritation. In subchronic inhalation
comments by the comment period pesticide chemical residue, including studies, DBE had a systemic inhalation
deadline identified. all anticipated dietary exposures and all NOAEL ≥ 0.40 mg/L (400 milligrams/
other exposures for which there is milliliter (mg/m3)), but a nasal irritation
II. Background and Statutory Findings NOAEL < 0.02 mg/L (20 mg/m3). DBE
reliable information.’’ This includes
In the Federal Register of December exposure through drinking water and in did not induce neurotoxicity or
23, 1998 (63 FR 71126) (FRL–6047–7), residential settings, but does not include carcinogenicity in the studies reviewed,
EPA issued a notice under section occupational exposure. Section and it was negative for mutagenicity in
408(d)(3) of the FFDCA, 21 U.S.C. 408(b)(2)(C) of the FFDCA requires EPA most tests, but positive for chromosomal
346a(d)(3), announcing the filing of a to give special consideration to aberrations under activated conditions.
pesticide petition (PP 5E4442) by exposure of infants and children to the In a repeat-dose inhalation reproduction
Whitmire Micro-Gen Research pesticide chemical residue in toxicity study, DBE had a NOAEL of
Laboratories, Inc., 3568 Tree Court establishing a tolerance and to ‘‘ensure 0.40 mg/L (400 mg/m3) and a Lowest
Industrial Blvd., St. Louis, MO 63122– that there is a reasonable certainty that effect level (LEL) of 1.0 mg/L (1,000 mg/
6682. The petition requested that 40 no harm will result to infants and m3) based on decreased pup weights at
CFR 180.910 and 180.930 be amended children from aggregate exposure to the weaning. In repeat-dose inhalation
by establishing a tolerance for residues pesticide chemical residue....’’ exposure studies, developmental
of the inert ingredient DBE. This notice EPA performs a number of analyses to toxicity was observed at higher doses
included a summary of the petition determine the risks from aggregate (1.0 mg/L or 1,000 mg/m3) than
prepared by Whitmire Micro-Gen exposure to pesticide residues. For maternal toxicity (0.16 mg/L or 160 mg/
Research Laboratories, Inc., the further discussion of the regulatory m3).
petitioner. There were no comments requirements of section 408 of the
received in response to the notice of In studies, DBE did not cause dermal
FFDCA and a complete description of
filing. irritation in animals exposed for four
the risk assessment process, see http://
The typical process used by EPA in www.epa.gov/fedrgstr/EPA-PEST/1997/ hours, but caused severe irritation
considering new tolerance exemptions November/Day-26/p30948.htm. (severe erythema and mild edema) in
for inert ingredients is to publish the one animal and reversible mild to
petition for public comment in a Notice III. Risk Characterization and moderate irritation in animals exposed
of Filing, evaluate the available data and Conclusions to DBE for 24 hours. DBE was not
information on the chemical, and Consistent with section 408(b)(2)(D) considered to be a skin-sensitizer in
publish a final rule in the Federal of the FFDCA, EPA has reviewed the guinea pigs. In repeat-dermal exposure
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Register if the Agency concludes that a available scientific data and other studies conducted on the rat, DBE had
tolerance exemption can be established. relevant information in support of this a systemic dermal NOAEL of 1,000 mg/
In the case of DBE, a significant number action and considered its validity, kg/day, and dermal irritation lowest
of new studies on DBE were received by completeness and reliability and the observed adverse effect level (LOAEL) of
EPA after the publication of the Notice relationship of this information to 100 mg/kg/day based on the slight, but
of Filing [see the Federal Register of human risk. EPA has also considered reversible, erythema and edema.

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Federal Register / Vol. 72, No. 167 / Wednesday, August 29, 2007 / Proposed Rules 49691

B. Exposure Assessment produced by other substances. For the Actions Concerning Regulations That
The use of DBE in pesticide products purposes of this tolerance action, Significantly Affect Energy Supply,
is being limited to 10% or less of therefore, EPA has not assumed that Distribution, or Use (66 FR 28355, May
microencapsulated pesticide DBE has a common mechanism of 22, 2001). This proposed rule does not
formulations with the insecticide active toxicity with other substances. For contain any information collections
ingredient cyfluthrin. Uses of cyfluthrin information regarding EPA’s efforts to subject to OMB approval under the
are currently limited to food-use determine which chemicals have a Paperwork Reduction Act (PRA), 44
applications such as spot and crack and common mechanism of toxicity and to U.S.C. 3501 et seq., or impose any
crevice treatments in food processing evaluate the cumulative effects of such enforceable duty or contain any
plants and food storage areas, and it is chemicals, see EPA’s website at http:// unfunded mandate as described under
typically applied by commercial www.epa.gov/pesticides/cumulative. Title II of the Unfunded Mandates
applicators. Dietary exposures of E. Other Considerations Reform Act of 1995 (UMRA) (Public
concern from residues in food and Law 104–4). Nor does it require any
1. Analytical methods. Adequate special considerations under Executive
drinking water are not anticipated. The enforcement methodology is available to
microencapsulated formulation and its Order 12898, entitled Federal Actions to
enforce the tolerance expression. The Address Environmental Justice in
restriction to use with one active method may be requested from: Chief,
ingredient will reduce the potential for Minority Populations and Low-Income
Analytical Chemistry Branch, Populations (59 FR 7629, February 16,
residential exposures (inhalation and Environmental Science Center, 701
dermal) to a minimal level. DBE is also 1994); or OMB review or any Agency
Mapes Rd., Ft. Meade, MD 20755–5350; action under Executive Order 13045,
used in non-pesticide consumer telephone number: (410) 305-2905; e-
products such as paint solvents. The use entitled Protection of Children from
mail address: residuemethods@epa.gov. Environmental Health Risks and Safety
of DBE as an inert ingredient in Residues are not expected because of
pesticide formulations, with the above Risks (62 FR 19885, April 23, 1997).
the low amount that will be permitted This action does not involve any
limitations, is not expected to contribute in the pesticide formulation (limited to
significantly to exposures from its use in technical standards that would require
10% W/W or less) and the limitation of Agency consideration of voluntary
non-pesticide consumer products. use with one pesticide active ingredient. consensus standards pursuant to section
C. Safety Factor for Infants and Children 2. International tolerances. The
12(d) of the National Technology
Agency is not aware of any country
Section 408 of the FFDCA provides Transfer and Advancement Act of 1995
requiring a tolerance for DBE, nor have
that EPA shall apply an additional (NTTAA), Public Law 104–13, section
any CODEX Maximum Residue Levels
tenfold margin of safety for infants and 12(d) (15 U.S.C. 272 note). Pursuant to
(MRLs) been established for any food
children in the case of threshold effects the Regulatory Flexibility Act (RFA) (5
crops at this time.
to account for prenatal and postnatal U.S.C. 601 et seq.), the Agency hereby
toxicity and the completeness of the F. Determination of Safety and certifies that this proposed action will
database on toxicity and exposure Conclusions not have significant negative economic
unless EPA determines that a different Based on the information in this impact on a substantial number of small
margin of safety will be safe for infants preamble, EPA concludes that there is a entities. Establishing a pesticide
and children. Margins of safety are reasonable certainty of no harm to the tolerance or an exemption from the
incorporated into EPA risk assessments general population, including infants requirement of a pesticide tolerance is,
either directly through use of a MOE and children, from aggregate exposure in effect, the removal of a regulatory
analysis or through using uncertainty to residues of DBE. Accordingly, EPA restriction on pesticide residues in food
(safety) factors in calculating a dose finds that exempting DBE from the and thus such an action will not have
level that poses no appreciable risk to requirement of a tolerance will be safe. any negative economic impact on any
humans. The toxicity database is entities, including small entities. In
sufficient for DBE and potential IV. Conclusion addition, the Agency has determined
exposure is adequately characterized A tolerance exemption is proposed for that this action will not have a
based on the low use rate. In terms of residues of DBE when it is used as an substantial direct effect on States, on the
hazard, there are low concerns and no inert ingredient solvent material/anti- relationship between the National
residual uncertainties regarding prenatal freeze microencapsulated at 10% W/W government and the States, or on the
and/or postnatal toxicity. or less in pesticide formulations with distribution of power and
the active ingredient cyfluthrin. responsibilities among the various
D. Cumulative Exposure levels of government, as specified in
Section 408(b)(2)(D)(v) of the FFDCA V. Statutory and Executive Order Executive Order 13132, entitled
requires that, when considering whether Reviews Federalism (64 FR 43255, August 10,
to establish, modify, or revoke a This action proposes to establish a 1999). Executive Order 13132 requires
tolerance, the Agency consider tolerance exemption under section EPA to develop an accountable process
‘‘available information’’ concerning the 408(d) of the FFDCA in response to a to ensure ‘‘meaningful and timely input
cumulative effects of a particular petition submitted to the Agency. The by State and local officials in the
pesticide’s residues and ‘‘other Office of Management and Budget development of regulatory policies that
substances that have a common (OMB) has exempted these types of have federalism implications.’’ ‘‘Policies
mechanism of toxicity.’’ Unlike other actions from review under Executive that have federalism implications’’ is
pesticides for which EPA has followed Order 12866, entitled Regulatory defined in the Executive order to
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a cumulative risk approach based on a Planning and Review (58 FR 51735, include regulations that have
common mechanism of toxicity, EPA October 4, 1993). Because this proposed ‘‘substantial direct effects on the States,
has not made a common mechanism of rule has been exempted from review on the relationship between the national
toxicity finding as to DBE and any other under Executive Order 12866 due to its government and the States, or on the
substances, and the chemical does not lack of significance, this proposed rule distribution of power and
appear to produce a toxic metabolite is not subject to Executive Order 13211, responsibilities among the various

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49692 Federal Register / Vol. 72, No. 167 / Wednesday, August 29, 2007 / Proposed Rules

levels of government.’’ This proposed § 180.1277 Dibasic esters; Exemption from Reference Information Center at Portals
rule directly regulates growers, food the requirement of a tolerance. II, CY–A257, 445 Twelfth Street, SW.,
processors, food handlers and food Dibasic esters (CAS Reg. No. 95481– Washington, DC 20554. This document
retailers, not States. This action does not 62–2) is exempted from the requirement may also be purchased from the
alter the relationships or distribution of of a tolerance for residues when used as Commission’s copy contractor, Best
power and responsibilities established an inert ingredient (solvent material/ Copy and Printing, Inc., Portals II, 445
by Congress in the preemption anti-freeze) at 10% W/W or less in 12th Street, SW., Room CY–B402,
provisions of section 408(n)(4) of the microencapsulated pesticide Washington, DC 20554, telephone 1–
FFDCA. For these same reasons, the formulations with the active ingredient 800–378–3160 or www.BCPIWEB.com.
Agency has determined that this cyfluthrin. This document does not contain
proposed rule does not have any ‘‘tribal [FR Doc. E7–17109 Filed 8–28–07; 8:45 am] proposed information collection
implications’’ as described in Executive BILLING CODE 6560–50–S requirements subject to the Paperwork
Order 13175, entitled Consultation and Reduction Act of 1995, Public Law 104–
Coordination with Indian Tribal 13. In addition, therefore, it does not
Governments (65 FR 67249, November FEDERAL COMMUNICATIONS contain any proposed information
6, 2000). Executive Order 13175, COMMISSION collection burden ‘‘for small business
requires EPA to develop an accountable concerns with fewer than 25
process to ensure ‘‘meaningful and 47 CFR Part 73 employees,’’ pursuant to the Small
timely input by tribal officials in the Business Paperwork Relief Act of 2002,
[DA 07–3559; MB Docket No. 07–164; RM–
development of regulatory policies that 11386] Public Law 107–198, see 44 U.S.C.
have tribal implications.’’ ‘‘Policies that 3506(c)(4). Provisions of the Regulatory
have tribal implications’’ is defined in Radio Broadcasting Services; Peach Flexibility Act of l980 do not apply to
the Executive order to include Springs, Arizona this proceeding.
regulations that have ‘‘substantial direct Members of the public should note
effects on one or more Indian tribes, on AGENCY: Federal Communications that from the time a Notice of Proposed
the relationship between the Federal Commission. Rule Making is issued until the matter
Government and the Indian tribes, or on ACTION: Proposed rule. is no longer subject to Commission
the distribution of power and consideration or court review, all ex
responsibilities between the Federal SUMMARY: This document requests
parte contacts are prohibited in
Government and Indian tribes.’’ This comments on a petition for rulemaking Commission proceedings, such as this
proposed rule will not have substantial filed by Smoke and Mirrors LLC, one, which involve channel allotments.
direct effects on tribal governments, on requesting the substitution Channel See 47 CFR 1.1204(b) for rules
the relationship between the Federal 268C3 for vacant Channel 285C3 at governing permissible ex parte contacts.
Government and Indian tribes, or on the Peach Springs, Arizona, and to amend
For information regarding proper
distribution of power and the reference coordinates for that
filing procedures for comments, see 47
responsibilities between the Federal allotment. Channel 268C3 can be
CFR 1.415 and 1.420.
Government and Indian tribes, as allotted at reference coordinates 35–29–
specified in Executive Order 13175. 35 NL and 113–35–17 WL. List of Subjects in 47 CFR Part 73
Thus, Executive Order 13175 does not DATES: Comments must be filed on or Radio, Radio broadcasting.
apply to this proposed rule. before October 1, 2007, and reply
For the reasons discussed in the
comments on or before October 16,
List of Subjects in 40 CFR Part 180 preamble, the Federal Communications
2007.
Commission proposes to amend 47 CFR
Environmental protection, ADDRESSES: Federal Communications Part 73 as follows:
Administrative practice and procedure, Commission, 445 Twelfth Street, SW.,
Agricultural commodities, Pesticides Washington, DC 20554. In addition to PART 73—RADIO BROADCAST
and pests, Reporting and recordkeeping filing comments with the FCC, SERVICES
requirements. interested parties should serve the
petitioner’s counsel as follows: Robert L. 1. The authority citation for part 73
Dated: August 20, 2007. Olender, Esq., Koerner & Olender, P.C., continues to read as follows:
Lois Rossi, 11913 Grey Hollow Court, North Authority: 47 U.S.C. 154, 303, 334, 336.
Director, Registration Division, Office of Bethesda, Maryland 20852.
Pesticide Programs. § 73.202 [Amended]
FOR FURTHER INFORMATION CONTACT:
Therefore, it is proposed that 40 CFR Deborah A. Dupont, Media Bureau, 2. Section 73.202(b), the Table of FM
chapter I be amended as follows: (202) 418–7072. Allotments under Arizona is amended
by removing Channel 285C3 and adding
SUPPLEMENTARY INFORMATION: This is a
PART 180—[AMENDED] Channel 268C3 at Peach Springs.
synopsis of the Commission’s Notice of
Proposed Rule Making, MB Docket No. Federal Communications Commission.
1. The authority citation for part 180
continues to read as follows: 07–164, adopted August 8, 2007, and John A. Karousos,
released August 10, 2007. The full text Assistant Chief, Audio Division, Media
Authority: 21 U.S.C. 321(q), 346a and 371. Bureau.
of this Commission decision is available
2. Section 180.1277 is added to for inspection and copying during [FR Doc. E7–17014 Filed 8–28–07; 8:45 am]
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subpart D to read as follows: normal business hours in the FCC’s BILLING CODE 6712–01–P

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