[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Rules and Regulations]
[Pages 32157-32161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12457]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0461; FRL-9385-9]


Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate; Exemption from 
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of methyl 5-(dimethylamino)-2-methyl-5-
oxopentanoate (1174627-68-9) when used as an inert ingredient solvent 
in

[[Page 32158]]

pesticide formulations applied to growing crops or to raw agricultural 
commodities after harvest. SciReg, Inc. (12733 Director's Loop, 
Woodbridge, VA 22192), on behalf of Rhodia Inc. (CN 7500, 8 Cedar Brook 
Drive, Cranbury, NJ 08512-7500) submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment 
of an exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate.

DATES: This regulation is effective May 29, 2013. Objections and 
requests for hearings must be received on or before July 29, 2013, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0461. All documents in the 
docket are available at http://www.regulations.gov or at the Office of 
Pesticide Programs Regulatory Public Docket (OPP Docket) in the 
Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., 
Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Mark Dow, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5533; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2012-0461 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
July 29, 2013. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0461, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at  http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of August 22, 2012 (77 FR 50661) (FRL-9358-
9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 2E8010) by 
SciReg, Inc. (12733 Director's Loop, Woodbridge, VA 22192), on behalf 
of Rhodia Inc. (CN 7500, 8 Cedar Brook Drive, Cranbury, NJ 08512-7500). 
The petition requested that 40 CFR 180.910 be amended by establishing 
an exemption from the requirement of a tolerance for residues of methyl 
5-(dimethylamino)-2-methyl-5-oxopentanoate (1174627-68-9) when used as 
an inert ingredient (solvent) in pesticide formulations applied to 
growing crops or to raw agricultural commodities after harvest (40 CFR 
180.910). That document referenced a summary of the petition prepared 
by SciReg, Inc. (12733 Director's Loop, Woodbridge, VA 22192), on 
behalf of Rhodia Inc. (CN 7500, 8 Cedar Brook Drive, Cranbury, NJ 
08512-7500), the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

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. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the

[[Page 32159]]

legal limit for a pesticide chemical residue in or on a food) only if 
EPA determines that the tolerance is ``safe.'' Section 408(b)(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 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 . . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated 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 FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of, and to make a 
determination on aggregate exposure for methyl 5-(dimethylamino)-2-
methyl-5-oxopentanoate, including exposure resulting from the exemption 
established by this action. EPA's assessment of exposures and risks 
associated with methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies 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. Specific information on the studies received and the nature 
of the adverse effects caused by methyl 5-(dimethylamino)-2-methyl-5-
oxopentanoate as well as the no-observed-adverse-effect-level (NOAEL) 
and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity 
studies are discussed in this unit.
    Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate is not acutely 
toxic via the oral or dermal routes of exposure. It is not a primary 
eye irritant, a primary skin irritant, or a dermal sensitizer. A repeat 
dose reproduction/developmental toxicity study showed no treatment-
related effects on mating or fertility. There were no treatment-related 
effects on gestation, litter size, litter growth, and development as 
compared to controls. There was no evidence of any toxicity in the 
parameters evaluated in this study. The NOAEL for systemic toxicity was 
considered to be 1,000 milligram/kilograms body weight/day (mg/kg bw/
day), the highest dose tested; a LOAEL was not observed in this study. 
A Bacterial Reverse Mutation Assay with Salmonella typhimurium 
concluded methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate did not 
induce mutagenic activity. A Gene Mutation Assay with Chinese hamster 
cells showed no reproducible dose-dependent increase in gene mutation 
frequency. A Chromosome Aberration Test with Human Lymphocytes in vitro 
showed no signs of cells carrying structural chromosomal aberrations. 
There was no evidence of an increase in polyploidy metaphases after 
treatment with methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate. A 
Mammalian Erythrocyte Micronucleus Test with mice revealed no 
statistically significant decreases in the PCE/NCE ratio therefore, 
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate, is considered to be 
negative for genotoxicity. Methyl 5-(dimethylamino)-2-methyl-5-
oxopentanoate, is considered non-mutagenic, there are no known data 
that directly suggest that methyl 5-(dimethylamino)-2-methyl-5-
oxopentanoate is carcinogenic. Based on the absence any toxicity at the 
limit dose, lack of mutagenicity concerns, and lack of carcinogenicity 
triggers in the Derek analysis, EPA concluded that methyl 5-
(dimethylamino)-2-methyl-5-oxopentanoate is unlikely to pose a cancer 
risk at anticipated human exposures. Neurotoxicity was not observed in 
a reproduction/developmental toxicity screening study in rats, where 
neurotoxic parameters were evaluated. Immunotoxicity studies were not 
available for review. However, signs of immunotoxicity were not 
observed in any of the submitted studies.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that methyl 5-
(dimethylamino)-2-methyl-5-oxopentanoate has a very low overall 
toxicity. The NOAEL is 1,000 mg/kg bw/day (limit dose). Since signs of 
toxicity were not observed at the limit dose, an endpoint of concern 
for risk assessment purposes was not identified. Therefore, since no 
endpoint of concern was identified for the acute, and chronic dietary 
exposure assessments, and short-, and intermediate-term dermal, and 
inhalation exposure assessments, a quantitative risk assessment for 
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate is not necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate, EPA 
considered exposure under the proposed exemption from the requirement 
of a tolerance. EPA assessed dietary exposures from methyl 5-
(dimethylamino)-2-methyl-5-oxopentanoate in food as follows: Dietary 
exposure to methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate can occur 
from eating food treated with pesticide formulations containing this 
inert ingredient. In addition, food can pick up residues of methyl 5-
(dimethylamino)-2-methyl-5-oxopentanoate that has been used in 
pesticide formulations applied to treat food contact surfaces, thus 
resulting in indirect exposure. However, since an endpoint of concern 
for risk assessment was not identified, a quantitative dietary exposure 
assessment for methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate was 
not conducted.
    2. Dietary exposure from drinking water. Dietary exposure from 
drinking water to methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate can 
occur by drinking water that has been contaminated by run-off from a 
pesticide treated area, and from antimicrobial formulations used in 
food-contact surface sanitizing solutions. Since an endpoint for risk 
assessment was not identified, a quantitative dietary exposure 
assessment from drinking

[[Page 32160]]

water for methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate was not 
conducted.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate may be used in 
inert ingredients in pesticide products that are registered for 
specific uses that may result in both indoor and outdoor residential 
exposures. However, since there are no toxicological effects of concern 
occurring below the limit dose of 1,000 mg/kg bw/day, it is not 
necessary to conduct quantitative assessments of residential (non-
occupational) exposures and risks. There are no dermal or inhalation 
toxicological endpoints of concern to the Agency, therefore, 
quantitative assessments have not been conducted.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate 
to share a common mechanism of toxicity with any other substances, and 
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate does not have 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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 database on 
toxicity and exposure, unless EPA determines, based on reliable data 
that a different margin of safety will be safe for infants and 
children. This additional margin of safety is commonly referred to as 
the Food Quality Protection Act (FQPA) safety factor. In applying this 
provision, EPA either retains the default value of 10X, or uses a 
different additional safety factor when reliable data available to EPA 
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
qualitative or quantitative susceptibility of infants and children in 
the available database.
    3. Conclusion. As part of its qualitative assessment, the Agency 
did not use safety factors for assessing risk, and no additional safety 
factor is needed for assessing risk to infants and children. The 
available toxicity studies suggest low toxicity of methyl 5-
(dimethylamino)-2-methyl-5-oxopentanoate. The toxicity database for 
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate contains acute oral, 
dermal and inhalation toxicity studies; skin, eye, and sensitization 
studies; mutagenicity studies (gene mutation, chromosomal aberrations 
assay), including in vivo micronucleus assay; and reproduction/
developmental toxicity screening study in the rat. There is no 
indication based upon the available data that methyl 5-(dimethylamino)-
2-methyl-5-oxopentanoate is a neurotoxic or immunotoxic chemical, or 
results in increased qualitative or quantitative susceptibility in 
infants or children. Based on this information, there is no concern, at 
this time, for increased sensitivity to infants and children to this 
chemical when used as inert ingredient in pesticides formulations.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on methyl 5-
(dimethylamino)-2-methyl-5-oxopentanoate, EPA has determined that there 
is a reasonable certainty that no harm to any population subgroup will 
result from aggregate exposure to methyl 5-(dimethylamino)-2-methyl-5-
oxopentanoate under reasonably foreseeable circumstances. Therefore, 
the establishment of an exemption from tolerance under 40 CFR 180.910 
for residues of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate when 
used as an inert ingredient, specifically as a solvent, in pesticide 
formulations applied to growing crops and to raw agricultural 
commodities after harvest, is safe under FFDCA section 408.
    1. Aggregate cancer risk for U.S. population. For the reasons 
stated in Unit IV.A. methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate 
is not expected to pose a cancer risk to humans.
    2. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate residues 
when used as an inert ingredient in pesticide formulations under 40 CFR 
180.910.

V. 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 Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food 
and Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for Methyl 5-(dimethylamino)-2-
methyl-5-oxopentanoate.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for methyl 5-(dimethylamino)-2-methyl-
5-oxopentanoate. (1174627-68-9) when used as an inert ingredient 
(solvent) in pesticide formulations applied to growing crops and to raw 
agricultural commodities after harvest.

VII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to

[[Page 32161]]

the Agency. The Office of Management and Budget (OMB) has exempted 
these types of actions from review under Executive Order 12866, 
entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 
1993). Because this final rule has been exempted from review under 
Executive Order 12866, this final rule is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), 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 FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: May 20, 2013
Lois A. Rossi,
Director, Registration Division, Office of Pesticide Programs.
    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. In Sec.  180.910, alphabetically add the following inert ingredient 
to the table to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
      Inert ingredients              Limits                 Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Methyl 5-(dimethylamino)-2-   ....................  Solvent
 methyl-5-oxopentanoate
 (1174627-68-9).
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2013-12457 Filed 5-28-13; 8:45 am]
BILLING CODE 6560-50-P