
[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Rules and Regulations]
[Pages 73934-73937]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29903]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0669; FRL-9369-3]


Bacillus subtilis Strain QST 713 Variant Soil; Amendment to an 
Exemption From the Requirement of a Tolerance for Bacillus subtilis 
Strain QST 713 To Include Residues of Bacillus subtilis Strain QST 713 
Variant Soil

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the existing exemption from the 
requirement of a tolerance for residues of the Bacillus subtilis strain 
QST 713 in or on all food commodities by including residues of Bacillus 
subtilis strain QST 713 variant soil. Agraquest, Inc. submitted a 
petition to the EPA under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), requesting an amendment to an existing exemption from the 
requirement of a tolerance for Bacillus subtilis strain QST 713 to 
include residues of products containing Bacillus subtilis strain QST 
713 variant soil in or on all agricultural commodities. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Bacillus subtilis strain QST 713 variant soil under the 
FFDCA.

DATES: This regulation is effective December 12, 2012. Objections and 
requests for hearings must be received on or before February 11, 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-2011-0669, is 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: Michael Glikes, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 305-6231; email 
address: glikes.michael@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. 
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. To access the OCSPP test guidelines referenced in this 
document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''

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 the EPA, you must 
identify docket ID number EPA-HQ-OPP-2011-0669 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 February 11, 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 CBI) for inclusion in the public docket. 
Information not marked confidential pursuant to 40 CFR part 2 may be 
disclosed publicly by the EPA without prior notice. Submit the non-CBI 
copy of your objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0669, 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 Confidential Business 
Information (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

[[Page 73935]]

follow the instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of September 7, 2011 (76 FR 55329) (FRL-
8886-7), the EPA issued a notice pursuant to FFDCA section 408(d)(3), 
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 1F7896) by Agraquest, Inc., 1540 Drew Ave., Davis, CA 
95618. The petition requested that 40 CFR part 180.1209 be amended by 
including residues of Bacillus subtilis strain QST 713 variant soil. 
This notice referenced a summary of the petition prepared by the 
petitioner, Agraquest, Inc., which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows the 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 the EPA determines 
that the exemption 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. Pursuant to FFDCA section 
408(c)(2)(B), in establishing or maintaining in effect an exemption 
from the requirement of a tolerance, EPA must take into account the 
factors set forth in FFDCA section 408(b)(2)(C), which require 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 * * *.'' Additionally, FFDCA section 408(b)(2)(D) requires that 
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.''
    The EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, the EPA determines the 
toxicity of pesticides. Second, the EPA examines exposure to the 
pesticide through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with FFDCA section 408(b)(2)(D), the 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. 
The EPA has also considered available information concerning the 
variability of the sensitivities of major identifiable subgroups of 
consumers, including infants and children.
    Bacillus subtilis is a rod-shaped, gram-positive, aerobic flagellar 
bacterium that is ubiquitous in nature and has been recovered from 
water, soil, air, and decomposing plant residues (Ref 1.). The 
bacterium produces an endospore that allows it to endure extreme 
conditions of heat and desiccation in the environment (Ref. 1). 
Bacillus subtilis is not considered toxic or pathogenic to humans, 
animals, or plants (Ref. 2). Several strains of Bacillus subtilis are 
used predominantly as fungicidal active ingredients in various 
pesticides registered with the EPA.
    In 2000, the EPA first registered Bacillus subtilis strain QST 713 
as a pesticide active ingredient. EPA described the nature and 
toxicological profile of Bacillus subtilis strain QST 713 in the 
Federal Register of July 5, 2000 (65 FR 41365) (FRL-6555-3) as the 
basis for establishing the tolerance exemption for Bacillus subtilis 
strain QST 713 in or on all food commodities at 40 CFR 180.1209. A 
battery of tests, as described in that Federal Register citation, 
determined that Bacillus subtilis strain QST 713 is not pathogenic and 
has no significant toxicity. The petitioner is now requesting that this 
tolerance be amended to include residues of Bacillus subtilis strain 
QST 713 variant soil. Bacillus subtilis strain QST 713 variant soil is 
a naturally occurring variant of Bacillus subtilis strain QST 713 and 
is present in products containing the active ingredient Bacillus 
subtilis strain QST 713, although at low levels (Ref. 3). The variant 
strain is distinguished from the parent strain by the presence of the 
swrA gene, which is an essential gene for Bacillus to move over solid 
substances, and by a phenotype associated with enhanced biofilm 
formation, growth promotion and disease protection (Ref. 3). Based on 
its review of the variant and studies submitted by the petitioner, EPA 
concludes that the variant and the parent strain are substantially 
similar for the purposes of assessing toxicity, pathogenicity and 
infectivity (Ref. 3).
    The applicant, Agraquest, Inc., cited or submitted adequate 
mammalian toxicology data and information to support the exemption from 
the requirement of a tolerance for residues of Bacillus subtilis strain 
QST 713 variant soil in or on all raw agricultural commodities. These 
data are cited and described in the EPA's March 2012 Bacillus subtilis 
Final Registration Review Decision (Ref. 1). In addition, Agraquest 
submitted an acute injection toxicity/pathogenicity study (OCSPP 
Guideline 885.3200; MRID 48530909) that showed that Bacillus subtilis 
strain QST 713 variant soil TGAI was not toxic, infective, or 
pathogenic to rats when injected intravenously at a dose of 6.6 x 10\8\ 
colony forming units.
    The applicant reported that no hypersensitivity incidents occurred 
during research, development, or testing of Bacillus subtilis strain 
QST 713 variant soil. Acceptable Tier I mammalian toxicology data and 
information support registration of the proposed end-use product, 
Serenade Soil DPZ. In light of the results of the acute toxicity/
pathogenicity data and the absence of hypersensitivity incidents, the 
EPA did not require testing at higher tiers (i.e., Tiers II and III).

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).

A. Dietary Exposure

    1. Food exposure. Due to the ubiquitous nature of the Bacillus 
subtilis and the concentrations of Bacillus subtilis and other closely 
related Bacillus species that already exist in the environment, the EPA 
expects human exposure to Bacillus subtilis strain QST 713 variant soil 
resulting from the proposed pesticidal uses will be no greater than 
existing human exposure to background levels of Bacillus subtilis. The 
EPA in its registration review decision (Ref. 1) concluded ``the risk 
posed to adults, infants, and children is likely to be minimal because 
of the low acute oral toxicity/pathogenicity

[[Page 73936]]

potential of Bacillus subtilis strain QST 713.'' Based on the EPA's 
evaluation of the Bacillus subtilis strain QST 713 data and the EPA's 
conclusion that Bacillus subtilis strain QST 713 and Bacillus subtilis 
strain QST 713 variant soil are substantially similar for the purposes 
of assessing toxicity, pathogenicity, and infectivity (Ref. 3), no 
adverse effects from dietary exposure to Bacillus subtilis strain QST 
713 variant soil from its pesticidal uses are expected (see Unit III.).
    2. Drinking water exposure. Because Bacillus subtilis is ubiquitous 
in the environment, exposure to the microbe through drinking water may 
already be occurring and likely will continue (Ref. 3). EPA expects 
exposures to Bacillus subtilis strain QST 713 variant soil to be not 
much greater than background levels because the proposed use patterns 
are soil directed and/or soil incorporated, thereby limiting contact 
with surface water by drift and runoff. Furthermore, ground water is 
not expected to have significant exposure to Bacillus subtilis strain 
QST 713 variant soil since, like other microorganisms, this microbial 
pesticide would likely be filtered out by the particulate nature of 
many soil types. If residues of Bacillus subtilis strain QST 713 
variant soil were to be transferred to surface or ground waters that 
are intended for eventual human consumption (e.g., through spray drift 
or runoff) and directed to wastewater treatment systems or drinking 
water facilities, Bacillus subtilis strain QST 713 variant soil likely 
would not survive the conditions water is subjected to in such systems 
or facilities, including chlorination, pH adjustments, filtration, and/
or occasional high temperatures. As discussed in the EPA's Bacillus 
subtilis Case 6012, Final Registration Review Decision (Ref. 1), intake 
of low levels of ubiquitous Bacillus subtilis in drinking water may 
occur, but exposure would represent a minimal risk due to the low 
toxicity of the strain. Similarly, exposure to other strains of 
Bacillus subtilis would not represent a greater risk. It is reasonable 
to conclude, based on the similarity in product composition and 
production, measured physical/chemical, and pathogenicity/infectivity 
toxicity data, that the risk from any potential exposure to Bacillus 
subtilis strain QST 713 variant soil resulting from the proposed 
pesticidal use would be minimal and equivalent to the risk from 
exposure to Bacillus subtilis strain QST 713.

B. Other Non-occupational Exposures

    The use sites proposed for products containing Bacillus subtilis 
strain QST 713 variant soil include both agricultural and residential 
garden sites, so the EPA expects there to be some non-occupational 
exposure as a result of the application of this pesticide. Given 
Bacillus subtilis strain QST 713 variant soil's natural occurrence in 
soil, the EPA determined that non-occupational exposure to the 
bacterium likely is already occurring (Ref. 3). Additional exposure to 
the microorganism, due to pesticidal applications, is likely to occur 
but is not expected to exceed EPA's level of concern, particularly in 
light of available data that demonstrate Bacillus subtilis strain QST 
713 is not toxic (acute dermal toxicity and acute pulmonary toxicity/
pathogenicity), non-irritating (primary dermal irritation), and not 
pathogenic (acute pulmonary toxicity/pathogenicity) and the EPA's 
conclusion that Bacillus subtilis strain QST 713 and Bacillus subtilis 
strain QST 713 variant soil are substantially similar for the purposes 
of assessing toxicity, pathogenicity, and infectivity (Ref. 3). Based 
on the toxicity information submitted to the EPA, aggregate exposure to 
Bacillus subtilis strain QST 713 variant soil would be below the levels 
in the safety testing conducted on Bacillus subtilis strain QST 713 and 
would not represent an undue risk due to the lack of residues of 
toxicological concern and the low toxicity of the active ingredient. 
The EPA concluded that non-dietary exposures to the general population, 
including infants and children, would not be expected to pose any 
quantifiable risk due to a lack of residues of toxicological concern.

V. 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.''
    Bacillus subtilis strain QST 713 variant soil does not operate via 
a toxic mode of action and thus does not share a common mechanism of 
toxicity with any other substances. Therefore, section 408(b)(2)(D)(v) 
does not apply.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that, in considering the 
establishment of a tolerance or tolerance exemption for a pesticide 
chemical residue, EPA shall assess the available information about 
consumption patterns among infants and children, special susceptibility 
of infants and children to pesticide chemical residues, and the 
cumulative effects on infants and children of the residues and other 
substances with a common mechanism of toxicity. In addition, FFDCA 
section 408(b)(2)(C) provides that EPA shall apply an additional 
tenfold (10X) margin of exposure (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 that a different margin of exposure (safety) will 
be safe for infants and children. This additional margin of exposure 
(safety) is commonly referred to as the Food Quality Protection Act 
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.
    Based on the information discussed in Unit III.B., EPA concludes 
that there are no threshold effects of concern to infants, children, or 
adults when Bacillus subtilis strain QST 713 variant soil is used as 
labeled in accordance with good agricultural practices. As a result, 
EPA concludes that no additional margin of exposure (safety) is 
necessary to protect infants and children and that not adding any 
additional margin of exposure (safety) will be safe for infants and 
children.
    Moreover, based on the same data and EPA analysis as presented 
directly above, the Agency is able to conclude that there is a 
reasonable certainty that no harm will result to the U.S. population, 
including infants and children, from aggregate exposure to the residues 
of Bacillus subtilis strain QST 713 variant soil when it is used as 
labeled and in accordance with good agricultural practices. Such 
exposure includes all anticipated dietary exposures and all other 
exposures for which there is reliable information. As discussed 
previously, there appears to be no potential for harm from this 
bacterium in its use as an antifungal agent via dietary exposure since 
the microorganism is non-toxic, non-pathogenic, and not infective. This 
conclusion is supported by the data on the substantially similar strain 
Bacillus subtilis strain QST 713, public literature and EPA's Bacillus 
subtilis Case 6012, Final Registration Review Decision (Ref. 1). EPA 
concludes that there is a reasonable certainty of no harm to infants 
and children from aggregate exposure to Bacillus subtilis strain QST 
713 variant soil.

[[Page 73937]]

VII. 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, the EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. The 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 Nations 
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. The 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 Bacillus subtilis strain 
QST 713 variant soil.

VIII. Conclusions

    The EPA concludes that there is a reasonable certainty that no harm 
will result to the U.S. population, including infants and children, 
from aggregate exposure to residues of Bacillus subtilis strain QST 713 
variant soil. Therefore, the EPA is amending the tolerance exemption 
for Bacillus subtilis strain QST 713 to include residues of Bacillus 
subtilis strain QST 713 variant soil in or on all food commodities when 
used in accordance with good agricultural practices.

IX. References

    1. U.S. EPA. 2010. Bacillus subtilis Final Registration Review 
Decision. Case 6012. March 2010.
    2. U.S. EPA. 1997. Bacillus subtilis Final Risk Assessment.
    3. U.S. EPA. July 11, 2012. Memorandum from Dr. Ibrahim S. Barsoum 
and Dr. John L. Kough to Michael Glikes: Review of Product Chemistry 
and Acute Toxicity Studies for Section 3 Registration of a new TGAI, 
Bacillus subtilis strain QST variant soil, and a new EP, Serenade soil 
DPZ (EPA Reg. No. 69592-EI).

X. Statutory and Executive Order Reviews

    This final rule amends an exiting tolerance under FFDCA section 
408(d) in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children From Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the exemption from 
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).

XI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the 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: November 26, 2012.
Steven Bradbury,
Director, 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. Revise Sec.  180.1209 to read as follows:


Sec.  180.1209  Bacillus subtilisstrain QST 713 and strain QST 713 
variant soil; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticides Bacillus subtilis strain QST 713 
and strain QST 713 variant soil when used in or on all food 
commodities.

[FR Doc. 2012-29903 Filed 12-11-12; 8:45 am]
BILLING CODE 6560-50-P


