
[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Rules and Regulations]
[Pages 18822-18825]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07557]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[EPA-HQ-OPPT-2012-0209; FRL-9907-36]


Final Enforceable Consent Agreement and Testing Consent Order for 
Octamethylcyclotetrasiloxane (D4); Export Notification

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; enforceable consent agreement and testing consent 
order.

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SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA has issued 
a testing consent order (Order) that incorporates an enforceable 
consent agreement (ECA) with Dow Corning Corporation, Evonik 
Corporation, Momentive Performance Materials USA Inc., Shin-Etsu 
Silicones of America, Inc., and Wacker Chemical Corporation (the 
Companies). The Companies have agreed to certain environmental testing 
that will be used by EPA to characterize sources and pathways of 
release of octamethylcyclotetrasiloxane (D4) to the environment and 
resulting exposures of aquatic and sediment dwelling organisms to D4, 
contributing to the Agency's efforts to understand potential 
environmental effects of D4. This document revises the listing for D4 
in the table of testing consent orders for substances and mixtures with 
Chemical Abstract Service (CAS) Registry Numbers. This document 
announces the ECA and the Order that incorporates the ECA for this 
testing, and summarizes the terms of the ECA. As a result of this 
action, exporters of D4, CAS No. 556-67-2, including persons who do not 
sign the ECA, are subject to TSCA export notification requirements.

DATES: The effective date of the ECA, the Order that incorporates the 
ECA, and this action is April 4, 2014.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2012-0209, 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.

FOR FURTHER INFORMATION CONTACT: For information on the ECA, contact: 
Mark Seltzer, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-2901; email address: seltzer.mark@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. Does this action apply to me?

    This action is directed to the public in general. The requirements 
in the ECA and the Order that incorporates the ECA only apply to those 
companies that are specifically named in the ECA. As of April 4, 2014 
any person who exports or intends to export any chemical that is the 
subject of the ECA and the Order that incorporates the ECA is subject 
to the export notification requirements of TSCA section 12(b) (see 40 
CFR part 707, subpart D, and Unit IV.B.). Although other types of 
entities could also be affected, most chemical manufacturers are 
usually identified under North American Industrial Classification 
System (NAICS) code 325 (Chemical manufacturing).

II. Background

A. What is Octamethylcyclotetrasiloxane (D4)?

    D4 is used as an intermediate for silicone copolymers and other 
chemicals. D4 is also used in industrial processing applications as a 
solvent (which becomes part of a product formulation or mixture), 
finishing agent, and an adhesive and sealant chemical (Ref. 1). It is 
also used for both consumer and commercial purposes in paints and 
coatings, and plastic and rubber products (Ref. 1) and has consumer 
uses in polishes, sanitation, soaps, detergents, adhesives, and 
sealants (Ref. 2).

B. Why does EPA need environmental effects data on D4?

    D4 persists in sediment and bioaccumulates in aquatic species. Data 
show D4 to be toxic to aquatic and sediment-dwelling species. EPA has 
concerns regarding the environmental effects of D4. Environmental 
testing will help develop a better understanding of the potential 
effects of this chemical in the environment.

III. ECA Development and Conclusion

A. How is EPA going to obtain environmental testing on D4?

    EPA initiated steps and agreed to enter into this ECA with the 
Companies. On February 26, 2014, EPA received the ECA signed by the 
Companies, and on March 28, 2014, EPA signed the ECA and the Order that 
incorporates the ECA. The effective date of the ECA and the Order that 
incorporates the ECA is April 4, 2014.
    EPA uses ECAs to accomplish testing of chemicals for public health 
and environmental effects where a consensus exists concerning the need 
for and scope of testing (40 CFR 790.1(c)). The procedures for ECA 
negotiations and the factors for determining whether a consensus exists 
are described at 40 CFR 790.22.

B. What is the subject of the ECA and order incorporating the ECA?

    As specified in the ECA, the purpose of the testing program is to 
conduct environmental testing to help in characterizing sources and 
pathways of release of D4 to the environment and

[[Page 18823]]

resulting exposures of aquatic and sediment dwelling organisms to D4.
    The signatory companies shall submit a draft Study Plan and Quality 
Assurance Project Plan (QAPP) to carry out the environmental testing 
program set forth in Section VII. and Appendices 1-8 of the ECA. EPA 
will review of the signatory companies' draft submissions and, if 
consistent with Section IX.A. of the ECA, shall approve the 
submissions. The signatory companies shall conduct environmental 
testing in accordance with the Final Study Plan and Final QAPP approved 
by EPA. Following completion of environmental testing, the signatory 
companies shall submit a final report to EPA.

C. What testing does the ECA for D4 require?

    The ECA requires testing for the presence of D4 around specified 
wastewater treatment plants (WWTP) at the method detection limits 
specified in the test standards described in Appendices 4-8 of the ECA.
    Environmental testing will be conducted at direct discharge sites 
WWTPs (Appendix 1 of the ECA). Direct discharge sites are D4 
manufacturing and/or processing sites that discharge process wastewater 
into the environment after on-site wastewater treatment. The 
concentration of D4 in the WWTP effluent (Appendix 4 of the ECA), and 
surface water (Appendix 5 of the ECA), sediment (Appendix 7 of the 
ECA), and biota (benthic organisms and two species of fish as noted in 
Appendix 8 of the ECA) in the WWTP receiving stream will be measured.
    Environmental testing will be conducted at WWTPs serving indirect 
discharge sites (Appendix 2 of the ECA). Indirect discharge sites are 
D4 processing sites (including product formulation sites) that 
discharge process wastewater to offsite WWTPs. The concentration of D4 
in the WWTP influent (Appendix 4 of the ECA), effluent (Appendix 4 of 
the ECA), and biosolids (Appendix 6 of the ECA), along with surface 
water (Appendix 5 of the ECA), sediment (Appendix 7 of the ECA), and 
biota (benthic organisms and two species of fish as noted in Appendix 8 
of the ECA) in the WWTP receiving stream will be measured.
    Primarily non-industrial WWTPs receive less than 15% of wastewater 
from industrial facilities and, preferably, no wastewater from D4 
manufacturing or processing (including product formulation) sites 
(Appendix 3 of the ECA). Environmental testing will be conducted at 
WWTPs serving primarily non-industrial wastewater treatment sites. The 
concentration of D4 in the WWTP influent (Appendix 4 of the ECA) and 
effluent (Appendix 4 of the ECA), and biosolids (Appendix 6 of the 
ECA), along with surface water (Appendix 5 of the ECA), sediment 
(Appendix 7 of the ECA), and biota (benthic organisms and two species 
of fish as noted in Appendix 8 of the ECA) in the WWTP receiving stream 
will be measured.

   Table 1--Required Testing, Test Standards, Reporting Requirements:
                  Phases of the Testing Program for D4
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                                     Enforceable consent
    Event            Phase         agreement (ECA) section     Deadline
                                          and terms           (days)\1\
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1............  Effective date..  XXII. Date of Federal                 0
                                  Register document
                                  publication.
2............  Submission of     IX.A. No more than 120              120
                Study Plan to     days after effective date
                EPA.              and at least 45 days
                                  prior to testing
                                  initiation.
3............  Submission of     IX.A. No more than 180              180
                Quality           days after effective date
                Assurance         and at least 45 days
                Project Plan      prior to testing
                (QAPP) to EPA.    initiation (EPA
                                  Requirements for Quality
                                  Assurance Project Plans
                                  (QA/R5)) (Ref. 3).
6............  Study Plan/QAPP   IX.A. Study plan/QAPP               240
                Approval.         approval at same time,
                                  within 60 days of receipt
                                  of QAPP by EPA.
7............  Start of testing  IX.B. Testing start no              300
                                  more than 60 days after
                                  study plan/QAPP approval;
                                  specific tests to be
                                  conducted at each site
                                  type as described in Unit
                                  III.C.
10...........  End of testing..  IX.B. Testing completed             660
                                  within 360 days of
                                  testing start.
12...........  Environmental     IX.D. Final report no               810
                Monitoring        later than 150 days
                Report.           following completion of
                                  testing.
------------------------------------------------------------------------
\1\ Number of days, starting with the day following the completion of
  the previous ECA phase.

D. What are the uses for the test data to be developed under the ECA?

    The final report is intended to be released to the public, as 
described at Section IX.D. of the ECA. These data will be used to 
develop D4 environmental exposure and risk assessments. In addition, 
the data could be used by other Federal agencies (e.g., the Agency for 
Toxic Substances and Disease Registry (ATSDR), the Consumer Product 
Safety Commission (CPSC), and the Food and Drug Administration (FDA)) 
in assessing chemical risks and in taking appropriate actions within 
their programs.

IV. Other Impacts of the ECA

A. What if EPA should require additional environmental testing on D4?

    If EPA decides in the future that it requires additional 
environmental testing data, the Agency has authority to re-open the 
testing consent order process according to 40 CFR 790.68.

B. How does the order affect TSCA export notification?

    As of the effective date of the ECA and the Order that incorporates 
the ECA under TSCA section 4 (i.e., the date of publication of this 
document in the Federal Register) any of the Companies, as well as any 
other person, who exports or intends to export any D4 that is the 
subject of this ECA and Order that incorporates the ECA, in any form, 
are subject to the export notification requirements of TSCA section 
12(b). Procedures related to export notification are described in 40 
CFR part 707, subpart D. EPA maintains lists of all chemical substances 
and mixtures with CAS numbers (40 CFR 799.5000) that are subject to 
testing consent orders. This document revises the listing for D4, CAS. 
No. 556-67-2, that is the subject of this ECA and Order that 
incorporates the ECA in the list at 40 CFR 799.5000.
    Section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 
553(b)(3)(B), provides that, when an agency for good cause finds that 
public notice and comment procedures are impracticable, unnecessary, or 
contrary to the public interest, the agency may issue a rule without 
providing notice and an opportunity for public comment.

[[Page 18824]]

EPA has determined that there is good cause for adding this chemical to 
the list at 40 CFR 799.5000 without prior proposal and opportunity for 
comment because such notice and opportunity for comment is unnecessary 
since the export notification requirements are imposed by statute. 
Section 12(b) of TSCA requires any person who exports or intends to 
export to a foreign country a chemical substance or mixture for which 
the submission of data is required under TSCA section 4 to submit a 
notification of the export or intended export to EPA. TSCA section 
12(b) operates regardless of whether this chemical is added to the list 
at 40 CFR 799.5000; the inclusion of this chemical in the list promotes 
awareness of that operation of statutory law. Therefore, EPA has 
determined that notice and an opportunity for comment on whether this 
chemical is added to the list at 40 CFR 799.5000 is unnecessary because 
the export notification requirements in TSCA section 12(b) would apply 
even if this chemical is not added to 40 CFR 799.5000.

C. What are the economic implications of the ECA?

    Based on the economic analysis conducted for the ECA, the Agency 
expects the cost of the testing to be performed under this ECA to range 
from $1,000,000 to $1,200,000. The estimated total cost for industry to 
conduct the required testing under the ECA is $1,200,000, which is the 
upper end of the estimated cost range. EPA anticipates that the costs 
for testing under this ECA will have a low potential for adverse 
economic impact on the regulated community because the costs for 
testing will be shared across five companies that are signatories to 
the ECA and the Order that incorporates the ECA.
    Export regulations promulgated pursuant to TSCA section 12(b)--40 
CFR part 707, subpart D--require only a one-time notification to each 
foreign country of export for each chemical for which data are required 
to be developed under TSCA section 4. EPA prepared estimates of the 
cost and burden of the July 27, 1993, amendment to the rules 
implementing TSCA section 12(b) and included these in the Information 
Collection Request to support the rule most recently updated in 2012 
(Ref. 4). EPA estimates that the average cost of preparing and 
submitting the TSCA section 12(b) notification for a submitter of any 
TSCA section12(b) notification is $79 when adjusted for inflation to 
2012 dollars with an associated average burden of 1.3 hours (Ref. 5).

V. References

    As indicated under ADDRESSES, a docket has been established for 
this final rule under docket ID number EPA-HQ-OPPT-2012-0209. The 
following is a listing of the documents that are specifically 
referenced in this action. 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. EPA. Chemical Data Reporting Database. 2012.
    2. EPA. Inventory Update Reporting Database. 2006.
    3. EPA. EPA Requirements for Quality Assurance Project Plans 
(QA/R5).
    4. EPA. Export Notification Requirement; Change to Reporting 
Requirements; Final Rule. Federal Register (58 FR 40238, July 27, 
1993.)
    5. EPA. Estimates of Burden and Costs for the Siloxanes 
Enforceable Consent Agreement. 2014.
    6. EPA. EPA ICR No.: 0795.14 Information Collection Request for 
Notification of Chemical Exports--TSCA Section 12(b) Supporting 
Statement for Request for OMB Review under the Paperwork Reduction 
Act, OMB Control Number 2070-0030. 2012.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action announces an Order that incorporates an ECA between EPA 
and the Companies. Under Executive Order 12866, entitled ``Regulatory 
Planning and Review'' (58 FR 51735, October 4, 1993), this action is 
not a ``regulatory action'' subject to review by the Office of 
Management and Budget (OMB).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to, an 
information collection request unless it displays a currently valid 
control number assigned by OMB. The OMB control numbers for the EPA's 
regulations in title 40 of the CFR are listed in 40 CFR part 9.
    The information collection requirements related to the Order that 
incorporates the ECA have already been approved by OMB pursuant to PRA 
under OMB control number 2070-0033 (EPA ICR No. 1139.09). The one-time 
public burden for this collection of information is estimated to be 
approximately 200 hours per response (i.e., per company), or 1,000 
hours total burden for the companies (Ref. 5). Under PRA, ``burden'' 
means the total time, effort, or financial resources expended by 
persons to generate, maintain, retain, or disclose or provide 
information to or for a Federal agency. For this collection, it 
includes the time needed to review instructions; complete and review 
the collection of information; and transmit or otherwise disclose the 
information.
    The information collection requirements related to export 
notification requirements under TSCA section 12(b), including those 
related to the ECA and the Order that incorporates the ECA, have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0030 (EPA ICR No. 0795). The public reporting burden for this 
information collection is estimated to be 1.3 hours per response (Ref. 
6).

C. Regulatory Flexibility Act (RFA)

    Since the issuance of the ECA and the Order that incorporates the 
ECA, as well as the applicability of the export notification 
requirements of TSCA section 12(b) to chemicals addressed in the ECA 
and the Order that incorporates the ECA, do not require the issuance of 
a proposed rule, the requirements of RFA (5 U.S.C. 601 et seq.) do not 
apply.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of UMRA (2 U.S.C. 1501 et 
seq.). Therefore, this action is not subject to the requirements of 
UMRA.

E. Executive Order 13132 and 13175

    This action is not expected to impact State or Tribal governments 
because these governments are not expected to export the chemicals 
covered by the ECA or the Order that incorporates the ECA. As such, the 
Agency has determined that this action will not have a substantial 
direct effect on States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999). Nor will this action have Tribal implications because it 
does not significantly or uniquely affect the communities of Indian 
Tribal governments, or involve or impose any requirements that affect 
Indian Tribes. Accordingly, the requirements of Executive Order 13175, 
entitled

[[Page 18825]]

``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000), do not apply.

F. Executive Order 13045

    Executive Order 13045, entitled ``Protection of Children from 
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 
1997), does not apply to this action because this action is not 
designated as an ``economically significant'' regulatory action as 
defined by Executive Order 12866 (see Unit VI.A.), nor does this action 
establish an environmental standard that is intended to have a 
disproportionate effect on children. To the contrary, this action will 
provide data and information that EPA and others can use to assess the 
risks of these chemicals, including potential risks to sensitive 
subpopulations.

G. Executive Order 13211

    This action 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), because 
this action is not expected to affect energy supply, distribution, or 
use.

H. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of NTTAA (15 U.S.C. 272 note) directs EPA to use 
voluntary consensus standards in its regulatory activities unless to do 
so would be inconsistent with applicable law or otherwise impractical. 
Voluntary consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, and business 
practices) that are developed or adopted by voluntary consensus 
standards bodies. The NTTAA directs EPA to provide Congress, through 
OMB, explanations when the Agency decides not to use available and 
applicable voluntary consensus standards.
    The testing conducted under the ECA involves technical standards. 
The Agency conducted a search to identify potentially applicable 
voluntary consensus standards. No such standard was identified for 
environmental testing of D4 that is the subject of the ECA.

I. Executive Order 12898

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).

VII. 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 799

    Environmental protection, Chemicals, D4, Exports, Hazardous 
substances, Health and safety, Laboratories, 
Octamethylcyclotetrasiloxane, Reporting and recordkeeping requirements, 
Siloxane.

    Dated: March 28, 2014.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
    Therefore, 40 CFR chapter I is amended as follows:

PART 799--[AMENDED]

0
1. The authority citation for part 799 continues to read as follows:

    Authority:  15 U.S.C. 2603, 2611, 2625.


0
2. In Sec.  799.5000, revise the entry ``CAS Number 556-67-2'' to read 
as follows:


Sec.  799.5000  Testing consent orders for substances and mixtures with 
Chemical Abstract Service Registry Numbers.

* * * * *

------------------------------------------------------------------------
                    Substance or                         FR publication
    CAS No.         mixture name         Testing              date
------------------------------------------------------------------------
 
                              * * * * * * *
556-67-2.......  Octamethylcyclote  Chemical fate....  January 10, 1989.
                  trasiloxane (D4). Environmental      January 10, 1989.
                                     effects.          April 4, 2014.
                                    Environmental
                                     testing.
 
                              * * * * * * *
------------------------------------------------------------------------

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[FR Doc. 2014-07557 Filed 4-3-14; 8:45 am]
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