
[Federal Register Volume 79, Number 211 (Friday, October 31, 2014)]
[Proposed Rules]
[Pages 64722-64725]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25849]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2014-0684; FRL-9918-27]


Discarded Polyvinyl Chloride; TSCA Section 21 Petition; Reasons 
for Agency Response

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition; reasons for Agency response.

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SUMMARY: This document announces the availability of EPA's response to 
a petition it received under the Toxic Substances Control Act (TSCA). 
The TSCA section 21 petition was received from the Center for 
Biological Diversity (CBD) on July 29, 2014. The petitioner requested 
that EPA initiate rulemaking under TSCA to address risks related to 
polyvinyl chloride (PVC), vinyl chloride, and phthalates used as 
plasticizers. The petitioner alternatively requested that EPA initiate 
rulemaking under TSCA to require additional toxicity testing of these 
chemical substances. After careful consideration, EPA has denied the 
TSCA section 21 petition for the reasons discussed in this document. 
The TSCA section 21 petition was accompanied by an independent petition 
for EPA to take action under the authority of the Resource Conservation 
and Recovery Act (RCRA). EPA continues to review the petitioner's 
requests for action under RCRA.

DATES: EPA's response to this TSCA section 21 petition was signed 
October 24, 2014..

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Paul Lewis, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-6738; email address: lewis.paul@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may, 
however, be of interest to those persons who produce, or who use PVC, 
vinyl chloride, or phthalates used as plasticizers, or substitutes for 
such chemical substances. Since many other entities may also be 
interested, the Agency has not attempted to describe all the specific 
entities that may be affected by this action.

B. How can I access information about this TSCA section 21 petition?

    The docket for this TSCA section 21 petition, identified by docket 
identification (ID) number EPA-HQ-OPPT-2014-0684, is available at 
http://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW., Washington, DC. 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 OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

II. TSCA Section 21

A. What is a TSCA section 21 petition?

    Under TSCA section 21 (15 U.S.C. 2620), any person can petition EPA 
to initiate a rulemaking proceeding for the issuance, amendment, or 
repeal of a rule under TSCA section 4, 6, or 8 or an order under TSCA 
section 5(e) or 6(b)(2). A TSCA section 21 petition must set forth the 
facts that are claimed to establish the necessity for the action 
requested. EPA is required to grant or deny the petition within 90 days 
of its filing. If EPA grants the petition, the Agency must promptly 
commence an appropriate proceeding. If EPA denies the petition, the 
Agency must publish its reasons for the denial in the Federal Register. 
15 U.S.C. 2620(b)(3). A petitioner may commence a civil action in a 
U.S. district court to compel initiation of the requested rulemaking 
proceeding within 60 days of either a denial or the expiration of the 
90-day period. 15 U.S.C. 2620(b)(4).

B. What criteria apply to a decision on a TSCA section 21 petition?

    Section 21(b)(1) of TSCA requires that the petition ``set forth the 
facts which it is claimed establish that it is necessary'' to issue the 
rule or order requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21 
implicitly incorporates the statutory standards that apply to the 
requested actions. In addition, TSCA section 21 establishes standards a 
court must use to decide whether to order EPA to initiate rulemaking in 
the event of a lawsuit filed by the petitioner after denial of a TSCA 
section 21 petition. 15 U.S.C. 2620(b)(4)(B). Accordingly, EPA has 
relied on the standards in TSCA section 21 and in the provisions under 
which actions have been requested to evaluate this TSCA section 21 
petition.

III. TSCA Sections 6 and 4

    Of particular relevance to this TSCA section 21 petition are the 
legal standards regarding TSCA section 6 rules and TSCA section 4 
rules.

A. TSCA Section 6 Rules

    To promulgate a rule under TSCA section 6, the EPA Administrator 
must find that ``there is a reasonable basis to conclude that the 
manufacture, processing, distribution in commerce, use, or disposal of 
a chemical substance or mixture . . . presents or will present an 
unreasonable risk.'' 15 U.S.C.

[[Page 64723]]

2605(a). This finding cannot be made considering risk alone. Under TSCA 
section 6, a finding of ``unreasonable risk'' requires the 
consideration of costs and benefits. Furthermore, the control measure 
adopted is to be the ``least burdensome requirement'' that adequately 
protects against the unreasonable risk. 15 U.S.C. 2605(a).
    In addition, TSCA section 21(b)(4)(B) provides the standard for 
judicial review should EPA deny a request for rulemaking under TSCA 
section 6(a): ``If the petitioner demonstrates to the satisfaction of 
the court by a preponderance of the evidence that . . . there is a 
reasonable basis to conclude that the issuance of such a rule . . . is 
necessary to protect health or the environment against an unreasonable 
risk of injury,'' the court shall order the EPA Administrator to 
initiate the requested action. 15 U.S.C. 2620(b)(4)(B). Also relevant 
to the issuance of regulations under TSCA section 6, TSCA section 9(b) 
directs EPA to take regulatory action on a chemical substance or 
mixture under other statutes administered by the Agency if the EPA 
Administrator determines that actions under those statutes could 
eliminate or reduce to a sufficient extent a risk posed by the chemical 
substance or mixture. If this is the case, the regulation under TSCA 
section 6 can be promulgated only if the EPA determines that it is in 
the ``public interest'' to protect against that risk under TSCA rather 
than the alternative authority. 15 U.S.C. 2608(b).

B. TSCA Section 4 Rules

    To promulgate a rule under TSCA section 4, EPA must make several 
findings. In all cases, EPA must find that data and experience are 
insufficient to reasonably determine or predict the effects of a 
chemical substance or mixture on health or the environment and that 
testing of the chemical substance is necessary to develop the missing 
data. 15 U.S.C. 2603(a)(1). In addition, EPA must find either that:
    1. The chemical substance or mixture may present an unreasonable 
risk of injury or
    2. The chemical substance is produced in substantial quantities and 
may either result in significant or substantial human exposure or 
result in substantial environmental release. 15 U.S.C. 2603(a)(1).
    In the case of a mixture, EPA must also find that ``the effects 
which the mixture's manufacture, distribution in commerce, processing, 
use, or disposal or any combination of such activities may have on 
health or the environment may not be reasonably and more efficiently 
determined or predicted by testing the chemical substances which 
comprise the mixture.'' 15 U.S.C. 2603(a)(2).

 IV. Summary of the TSCA Section 21 Petition

A. What action was requested?

    On July 29, 2014, the CBD submitted to EPA a ``Petition for 
Rulemaking Pursuant to Section 7004(a) of the Resource Conservation and 
Recovery Act, 42 U.S.C. 6974(A), and Section 21 of the Toxic Substances 
Control Act, 15 U.S.C. 2620, Concerning the Regulation of Discarded 
Polyvinyl Chloride and Associated Chemical Additives'' (Ref. 1). (The 
petitioner stated that it was submitting two ``independent and fully 
severable'' petitions: One under RCRA and another under TSCA. At this 
time, EPA is only responding to the TSCA section 21 petition. EPA 
continues to review the petitioner's requests for action under RCRA.)
    The TSCA section 21 petition states that it is requesting issuance 
of ``regulations governing the safe treatment, storage and disposal of 
polyvinyl chloride (``PVC''), vinyl chloride and associated dialkyl- 
and alkylarylesters of 1,2-benzenedicarboxylic acid, commonly known as 
phthalate plasticizers.'' In its conclusion, the petitioner urges EPA 
to ``promptly exercise its authority to ensure the safe disposal of 
discarded PVC.''
    The petitioner requested that EPA initiate rulemaking under TSCA 
section 6 ``to reduce the unreasonable risk to public health and the 
environment associated with continued dependence'' on PVC, vinyl 
chloride, and phthalates used as plasticizers. The petitioner also 
alternatively requested that EPA take action under TSCA section 4 
``requiring manufacturers and processors responsible for the generation 
of these compounds to undertake additional toxicity testing'' if ``the 
Agency concludes that there are insufficient data and experience upon 
which to determine or predict the effects of ubiquitous contamination'' 
for purposes of making a TSCA section 6 determination.
    EPA interprets the TSCA section 21 petition as requesting EPA to 
initiate a proceeding for the issuance of a rule under TSCA section 6 
to address risks related to the disposal of PVC. The TSCA section 21 
petition is unclear about whether it is referring to PVC resins or PVC-
based products, but, due to its emphasis on risks created by widespread 
disposal, EPA assumes the TSCA section 21 petition is about PVC-based 
products (i.e., plastics manufactured from PVC resin). EPA therefore 
interprets the TSCA section 21 petition as arguing that TSCA regulation 
of the disposal of PVC-based products is necessary in order to address 
certain post-disposal risks (including risks relating to chemical 
substances that the petitioner believes could be released by PVC-based 
products after disposal).
    Due to a lack of specificity regarding the particular action 
requested, and other grounds described in Unit V., EPA denied the TSCA 
section 21 petition to initiate rulemaking under TSCA section 6 to 
address risks from the disposal of PVC. As a part of its analysis, EPA 
also considered whether a broader interpretation of the TSCA section 21 
petition, as furthermore requesting regulation of the manufacture, 
processing, distribution, or use of PVC, would have altered the 
Agency's decision. EPA considered whether the facts set forth in the 
TSCA section 21 petition established that it was necessary to initiate 
TSCA section 6 rulemaking to ban or otherwise limit any specific use of 
PVC or vinyl chloride, phthalates as plasticizers, or metal-based heat 
stabilizers in manufacturing PVC as a means of reducing the quantities 
of such chemical substances that enter the disposal stream in the first 
place. As described in Unit V., EPA concluded that, under such a 
broader interpretation, EPA would have denied the TSCA section 21 
petition on similar grounds. The TSCA section 21 petition does not 
clearly state a pre-disposal risk management action that is sought, let 
alone demonstrate a risk that is unreasonable.
    Finally, EPA notes that it did not construe the petitioner's 
request for rulemaking under TSCA section 4 as a strictly contingent 
request, which EPA would only consider if it had previously reached 
particular factual conclusions on its own initiative (i.e., ``that 
there are insufficient data and experience upon which to determine or 
predict the effects of ubiquitous contamination''). Therefore, no 
inference of implicit agreement with such conclusions should be drawn 
from the fact that EPA has reviewed whether the TSCA section 21 
petition itself sets forth facts sufficient to justify the initiation 
of rulemaking to require toxicity testing under TSCA section 4.

B. What support does the petitioner offer?

    The petitioner states that PVC, vinyl chloride, and phthalates used 
as plasticizers pose ``significant threats'' to human health and the 
environment. While the TSCA section 21 petition

[[Page 64724]]

includes information on other chemical substances related to PVC (e.g., 
stating that vinyl chloride is also a concern), it focuses on the use 
of phthalates as plasticizers in PVC. The TSCA section 21 petition 
states that phthalates are the most abundant manmade chemicals in the 
environment and that ``virtually universal'' exposure to phthalates 
``could be the leading cause'' of human reproductive disorders. The 
petitioner expresses concern that ``these compounds'' bioaccumulate in 
living organisms, interfere with hormone regulation, and alter sexual 
development. The petitioner also expresses concern that ``human 
contamination probably exceeds previously published estimates'' and 
that harm might be occurring from ``exposure pathways outside the scope 
of traditional toxicity testing,'' such as ``synergistic'' effects from 
``multiple phthalates'' or other pollutants. Finally, citing a single 
study, the petitioner also states that ``less harmful alternatives'' to 
these chemical substances are available.

V. Disposition of TSCA Section 21 Petition

    After careful consideration, EPA denied the petitioner's request to 
initiate a TSCA section 6 rulemaking, because the TSCA section 21 
petition does not:
     Specify what risk management action it is requesting,
     Set forth sufficient facts to establish that the disposal 
of PVC, vinyl chloride, or phthalates used as plasticizers presents or 
will present an unreasonable risk, or
     Explain why action under TSCA would be preferable to 
action under other statutory authorities.
    EPA also denied the petitioner's request to initiate a TSCA section 
4 rulemaking to require further toxicity testing of PVC, vinyl 
chloride, or phthalates used as plasticizers, because the TSCA section 
21 petition does not set forth sufficient facts for EPA to find that 
the toxicity information available to the Agency is insufficient to 
permit a reasoned evaluation of the health or environmental effects of 
these PVC constituents, or for EPA to conclude that toxicity testing is 
necessary to develop any missing data.

A. Request for a Rule Under TSCA Section 6

    With respect to its request that EPA initiate a proceeding for the 
issuance of a rule under TSCA section 6 to address risks related to the 
manner of disposal of PVC, the TSCA section 21 petition's primary 
deficiencies are its failure to specify the risk management action 
sought and its failure to discuss several major issues intrinsic to an 
unreasonable risk determination (i.e., risk reduction that would be 
accomplished by such action and the reasonably ascertainable economic 
and other social consequences of the action).
    Section 21 of TSCA authorizes any person to petition EPA for the 
``issuance . . . of a rule'' under TSCA section 6. As EPA interprets 
this provision, asking for a rule entails telling EPA, with reasonable 
specificity, what action is sought in the TSCA section 21 petition. 
Simply citing to general legal authority and stating a desired outcome 
does not define an action, and thus fails this threshold requirement 
under TSCA section 21. EPA's interpretation is consistent with the 
short 90-day deadline for responding to such rulemaking petitions, as 
well as with TSCA's grant of de novo judicial review to petitioners. In 
any such proceeding, it would be necessary to supply the court with a 
specific description of the relief sought to inform any requested 
injunction that EPA ``initiate the action requested by the 
petitioner.'' See 15 U.S.C. 2620(b)(4)(B). Since the court's de novo 
review is itself a rehearing of the Agency's prior review of the TSCA 
section 21 petition, it follows that the TSCA section 21 petition 
itself must supply the specific description of the relief sought.
    Although the TSCA section 21 petition asserts that ``the inadequate 
management of PVC, vinyl chloride, and phthalate plasticizers poses 
significant threats to human and ecosystem health,'' the petitioner's 
argument as to the existence of unreasonable risk is hindered by a 
nearly complete lack of detail as to the TSCA risk management that it 
is seeking. While the petitioner stated the overall outcome that it 
hoped could be achieved (reduce risk to human health and the 
environment from the disposal of PVC), the petitioner did not state, in 
any reasonable manner, what action available under TSCA section 6 it 
sought in order to achieve that outcome.
    The TSCA section 21 petition, furthermore, failed to set forth 
sufficient facts bearing on the relative risk reduction and the 
reasonably ascertainable economic and other social consequences of the 
unspecified risk management action. These issues are integral to EPA's 
assessment of whether rulemaking under TSCA section 6 is necessary and, 
even more fundamentally, its assessment of whether a particular risk is 
in fact an unreasonable risk. This is because the finding of 
unreasonable risk is a judgement under which the decisionmaker 
determines that the risk of health or environmental injury from the 
chemical substance or mixture outweighs the burden to society of 
potential regulations (Ref. 2). Because the TSCA section 21 petition 
omits discussion of multiple issues that are intrinsic to the finding 
of unreasonable risk, the TSCA section 21 petition fails to set forth 
sufficient facts to establish that the disposal of PVC, vinyl chloride, 
or phthalates used as plasticizers presents or will present an 
unreasonable risk.
    Finally, while the petitioner acknowledges that PVC disposal might 
also be regulated under other EPA statutory authorities, such as RCRA, 
it has not explained why it believes it would be preferable to address 
the risks of disposal under TSCA, rather than through other statutory 
authorities. The petitioner's views on this question are especially 
difficult to infer given the absence of information about the 
particular TSCA risk management action sought. This omission is an 
impediment to assessing whether a TSCA section 6 rule would be an 
appropriate means of reducing potential risks related to the disposal 
of PVC, and (if so) how such action could be coordinated, consistent 
with TSCA section 9(b), with other actions that EPA has already taken 
with respect to these chemical substances under other statutes that EPA 
administers.
    For example, the petitioner did not explain why it believes vinyl 
chloride poses an unreasonable risk that should be addressed under TSCA 
despite the impact of multiple rules regulating this chemical substance 
under the Clean Air Act (42 U.S.C. 7400 et seq.), including one that 
was recently established in 2012 (Ref. 3). See 40 CFR part 61, subpart 
F, and 40 CFR part 63, subparts DDDDDD and HHHHHHH.
    EPA also notes that, if it had construed the TSCA section 21 
petition more broadly (i.e., as also seeking actions to address the 
manufacturing, processing, distribution in commerce, and use of PVC), 
then the TSCA section 21 petition's deficiencies would have been 
multiplied still further, since there would have been even more 
uncertainty as to the risk management being sought and, thus, even more 
uncertainty as to the existence of an unreasonable risk that would be 
necessary to regulate under TSCA section 6.
    Though offering some limited information (i.e., noting PVC 
production volumes, supplying some basic information on the uses of 
PVC, and citing a paper that lists some possible candidate substitutes 
for di (2-ethylhexyl)phthalate (DEHP), the TSCA

[[Page 64725]]

section 21 petition largely omits the sort of information that would be 
relevant to a cost-benefit and regulatory alternatives analysis for a 
proposed rule to require the substitution of the chemical substances 
currently used in the manufacture of PVC. The TSCA section 21 petition 
provides almost no information on the usefulness and effectiveness of 
particular substitutes, their relative toxicity, cost, degree of 
availability, and potential to reduce risk. The TSCA section 21 
petition also does not include any information on the costs and 
benefits of regulatory alternatives to explain why the petitioner 
believes any particular risk management action is the least burdensome 
requirement that adequately protects against an unreasonable risk.
    For example, the TSCA section 21 petition lacks a meaningful 
discussion of the feasibility and implications of replacing vinyl 
chloride, any particular phthalate currently used as a plasticizer in 
PVC, or any particular heat stabilizer currently used in PVC. While the 
petitioner makes a passing reference to ``the availability of less 
harmful alternatives,'' the TSCA section 21 petition does not identify 
any specific chemical substance as a reasonable substitute for any 
other chemical substance currently in use in PVC products. In support 
of its general suggestion that ``less harmful alternatives'' are 
available, the TSCA section 21 petition cites only a single study, 
which was itself limited to reviewing ``candidates'' for replacing one 
specific phthalate (DEHP). The review itself was, furthermore, limited 
to assessing how well the candidate chemical substances satisfied 
leachability criteria (Ref. 4).
    EPA published an action plan for phthalates in 2009. For purposes 
of the plan, EPA identified eight phthalates as appropriate subjects 
for development of an assessment and management strategy: butyl benzyl 
phthalate (BBP), dibutyl phthalate (DBP), DEHP, diisobutyl phthalate 
(DIBP), diisodecyl phthalate (DIDP), diisononyl phthalate (DINP), di-n-
pentyl phthalate (DnNPP), and di-n-octyl phthalate (DnOP). See, http://www.epa.gov/opptintr/existingchemicals/pubs/actionplans/phthalates.html. EPA's Phthalates Action Plan (Ref. 5) already observes 
that there are ``various possible alternatives of phthalates in 
plasticized PVC.'' See, http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/phthalates_actionplan_revised_2012-03-14.pdf. While the 
study cited by the petitioner is consistent with EPA's prior 
observation, the TSCA section 21 petition has not set forth facts 
(e.g., bearing on relative risks, benefits, utility, and cost) to 
establish that a TSCA section 6 rule requiring the replacement of 
particular PVC plasticizers in one or more particular applications 
would be necessary.

B. Request for Action Under TSCA Section 4

    Apparently anticipating that EPA might deny its request to issue a 
TSCA section 6 rule on the grounds that there are not sufficient 
toxicity data to justify a section 6 rule, the petitioner asked EPA to 
alternatively adopt a rule under TSCA section 4 requiring manufacturers 
and processors of PVC, vinyl chloride, and phthalate plasticizers ``to 
undertake additional toxicity testing.''
    EPA's denial of the request to issue a TSCA section 6 rule is not 
predicated on a determination that there are insufficient toxicity data 
to justify action under TSCA section 6. Furthermore, the TSCA section 
21 petition's failure to set forth evidence to justify the necessity of 
rulemaking under TSCA section 6 is not in itself evidence that the 
currently available toxicity information is inadequate. As noted in 
Unit IV.A., many of the information gaps in the submitted TSCA section 
21 petition are either unrelated, or only indirectly related, to the 
toxicity of these chemical substances. And the petitioner does not 
contend that its efforts to explain why rulemaking under TSCA section 6 
is necessary were impeded by a lack of information about the toxicity 
of these chemical substances.
    EPA is denying the request for rulemaking under TSCA section 4 
because the TSCA section 21 petition does not set forth sufficient 
facts for EPA to find that the toxicity information available to the 
Agency is insufficient to permit a reasoned evaluation of the health or 
environmental effects of these chemical substances, or for EPA to 
conclude that toxicity testing is necessary to develop any missing 
data.
    Although the petitioner suggests in very general terms that ``[non-
] traditional toxicity testing'' might produce results showing that 
these chemical substances are riskier than currently known, the 
petitioner does not identify any particular deficiency in what is 
currently known about the toxicity of these chemical substances, or 
specify what kind of ``non-traditional'' toxicity tests the petitioner 
believes are necessary. Neither does the TSCA section 21 petition 
indicate whether (and if so, why) the petitioner believes that any 
deficiencies in the availability of information about the toxicity of 
these chemical substances are precluding a reasoned evaluation of 
health or environmental effects. Even if the TSCA section 21 petition 
had established that the currently available toxicity information could 
be improved in particular respects for one or more of these chemical 
substances, it would not automatically follow that the currently 
available toxicity information is insufficient to permit a reasoned 
evaluation of health or environmental effects.

VI. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

    1. CBD. Petition for Rulemaking Pursuant to Section 7004(a) of 
the Resource Conservation and Recovery Act, 42 U.S.C. Sec.  6974(A), 
and Section 21 of the Toxic Substances Control Act, 15 U.S.C. Sec.  
2620, Concerning the Regulation of Discarded Polyvinyl Chloride and 
Associated Chemical Additives. July 29, 2014.
    2. EPA. Lead Fishing Sinkers; Response to Citizens' Petition and 
Proposed Ban; Proposed Rule. Federal Register (59 FR 11122, March 9, 
1994) (FRL-4643-3).
    3. EPA. National Emission Standards for Hazardous Air Pollutants 
for Polyvinyl Chloride and Copolymers Production; Final Rule. 
Federal Register (77 FR 22848, April 17, 2012) (FRL-9636-2).
    4. Kastner et al. Aqueous leaching of di-2-ethylhexyl phthalate 
and `green' plasticizers from poly(vinyl chloride). Science of the 
Total Environment. p. 432. 2012.
    5. EPA. Phthalates Action Plan. Revised. March 14, 2012.

List of Subjects in Chapter I

    Environmental protection, Hazardous substances, Phthalates, 
Plasticizers, Polyvinyl chloride, Vinyl chloride.

    Dated: October 24, 2014.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2014-25849 Filed 10-30-14; 8:45 am]
BILLING CODE 6560-50-P


