Document ID: EPA-HQ-OPPT-2012-0159-0001
Agency: epa
Document Type: Notice
Title: Electronic Reporting; Toxic Substances Control Act Notifications of Substantial Risk and For Your Information Submissions
Posted Date: 2014-03-19T04:00Z

[Federal Register Volume 79, Number 53 (Wednesday, March 19, 2014)]
[Notices]
[Pages 15329-15332]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06050]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2012-0159; FRL-9401-1]

Electronic Reporting; Toxic Substances Control Act Notifications 
of Substantial Risk and for Your Information Submissions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing that notifications of substantial risk under 
section 8(e) of the Toxic Substances Control Act (TSCA) and voluntary 
For Your Information (FYI) submissions may now be filed electronically 
using EPA's electronic document submission system, the Central Data 
Exchange (CDX). Use of this electronic reporting option will streamline 
and reduce the administrative costs and burdens of submitting paper-
based notifications of substantial risks and FYI submissions.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Katherine Sleasman, Chemical Control Division (7405M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001: telephone number: 
(202) 564-7716; email address: sleasman.katherine@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?

    You may be potentially affected by this action if you manufacture, 
process, import, or distribute in commerce chemical substances and 
mixtures. The following North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. 
Potentially affected entities may include, but are not limited to:
     Petroleum refiners and distributors (NAICS code 324).
     Chemical manufacturers, processors, and distributors 
(NAICS code 325).
     Electronics manufacturing (NAICS codes 334 and 335).
     Paints and coatings and adhesive manufacturing (NAICS code 
3255).
     Cleaning compounds and similar products manufacturing 
(NAICS code 3256).
     Automobiles manufacturing (NAICS code 3361).
     Manufacturers of plastic parts and components (NAICS code 
325211).
     Aircraft manufacturing (NAICS code 336411).
    If you have any questions regarding the applicability of this 
action to a particular entity, consult the technical person listed 
under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2012-0159. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, will be publicly 
available only in hard copy. Publicly available docket materials are 
available electronically at http://www.regulations.gov, or, if only 
available in hard copy, at the OPPT Docket. The OPPT Docket is located 
in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 
Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room 
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The telephone number of the EPA/DC Public 
Reading Room is (202) 566-1744, and the telephone number for the OPPT 
Docket is (202) 566-0280. Docket visitors are required

[[Page 15330]]

to show photographic identification, pass through a metal detector, and 
sign the EPA visitor log. All visitor bags are processed through an X-
ray machine and subject to search. Visitors will be provided an EPA/DC 
badge that must be visible at all times in the building and returned 
upon departure.

II. Background

A. What action is the Agency taking?

    The Agency is announcing the availability of an electronic 
reporting option for use by those who must submit a notification of 
substantial risk under TSCA section 8(e) and by those who wish to 
voluntarily submit a FYI submission. EPA is providing an electronic 
reporting option as part of broader Federal Government efforts to move 
to modern, electronic methods of information collection, which 
streamline processes and reduce overall burdens for all involved.
    EPA's TSCA section 8(e) 1978 policy statement and the amended 2003 
policy statement describe how paper-based submissions should be 
delivered to the Agency (Refs. 1 and 2). This document supplements the 
policy statements and describes how to use CDX, the Chemical Safety and 
Pesticide Program (CSPP) option, and the Chemical Information 
Submission System (CISS) web-based reporting tool to submit the 
notifications of substantial risk required by TSCA section 8(e), as 
well as voluntary FYI submissions, electronically to the Agency. The 
Agency will make appropriate information about electronic reporting 
related to TSCA section 8(e) notification of substantial risk and FYI 
submissions available online at http://www.epa.gov/oppt/tsca8e/pubs/reportingrequirements.html#submitreport.

B. What is the Agency's authority for taking this action?

    TSCA section 8(e) states, ``Any person who manufactures, processes, 
or distributes in commerce a chemical substance or mixture and who 
obtains information which reasonably supports the conclusion that such 
substance or mixture presents a substantial risk of injury to health or 
the environment shall immediately inform the Administrator of such 
information unless such person has actual knowledge that the 
Administrator has been adequately informed of such information.'' 15 
U.S.C. 2607(e).
    The Government Paperwork Elimination Act (GPEA), 44 U.S.C. 3504), 
(Ref. 3) requires Executive agencies to provide, when practicable, for:
    1. The option of the electronic maintenance, submission, or 
disclosure of information as a substitute for paper.
    2. The use and acceptance of electronic signatures.

C. Is Electronic reporting through CDX available for other EPA TSCA 
programs?

    For previous documents discussing electronic reporting under TSCA, 
including the use of CDX, see Refs. 4-7.

D. What are the benefits of CDX reporting and use of CISS?

    EPA encourages submitters of TSCA section 8(e) notifications of 
substantial risk and voluntary submissions, including FYI submissions, 
to adopt electronic reporting as the preferred submission method. 
Electronic reporting reduces the reporting burden for submitters by 
reducing the cost and time required to review, edit, and transmit data 
to the Agency, as well as the cost to retain required records related 
to that submission. CISS, the web-based reporting tool, enables 
efficient data transmittal and reduces errors through the use of the 
built-in validation procedures. CISS also allows submitters to share a 
draft submission within their organization, and more easily save a copy 
for their records or future use. The resource and time requirements to 
review and process data by the Agency will also be reduced and document 
storage and retrieval will require fewer resources. EPA will also 
benefit from receiving electronic submissions and being able to 
communicate back electronically with submitters.

III. Electronic Reporting Procedures

    This unit provides an overview of CDX, CSPP, and the CISS web-based 
reporting tool. It also provides instructions for the electronic 
reporting process for TSCA section 8(e) notifications of substantial 
risk and FYI submissions.

A. What is CDX?

    CDX is EPA's point of entry for environmental data submissions to 
the Agency. CDX also provides the capability for submitters to access 
their data through the use of web services. CDX enables EPA to work 
with stakeholders, including governments, regulated industries, and the 
public to enable streamlined, electronic submission of data via the 
Internet. To report under the procedures discussed in this notice, 
submitters would register with CDX, select the CSPP option, and use 
CISS to access reporting of TSCA section 8(e) notification of 
substantial risk and FYI submissions. More information about CDX is 
available online at http://www.epa.gov/cdx.

B. What is CISS?

    CISS is a web-based reporting tool for the submission of forms, 
reports, and other documents including TSCA section 8(e) notification 
of substantial risk and FYI submissions, electronically to the Agency. 
The tool is available for use with Windows, Mac, Linux, and UNIX 
computer systems, using ``Extensible Markup Language'' (XML) 
specifications for efficient data transmission across the Internet. 
CISS provides user-friendly navigation, works with CDX to secure online 
communication, creates a completed Portable Document Format (PDF) for 
review prior to submission, and enables data, reports, and other 
information to be submitted easily as PDF attachments, or by other 
electronic standards, such as XML. As currently implemented, one or 
more representatives from each facility must establish an account with 
EPA's CDX in order to prepare, transmit, certify, and submit forms, 
reports, and other documents.

C. How will TSCA Section 8(e) notification of substantial risk and FYI 
submissions be submitted via the internet using CDX?

    Submitters register with EPA's CDX, select the CSPP Program, and 
use CISS to prepare a data file for submission.
    1. Registering with CDX. To submit electronically to EPA via CDX, a 
user would register with CDX available online at https://cdx.epa.gov. 
CDX registration enables EPA to authenticate user identities and verify 
user authorizations.
    To register in CDX, the CDX registrant (also referred to as 
``Electronic Signature Holder'' or ``Public/Private Key Holder'') would 
agree to the terms and conditions, provide information about the user 
and organization, select a user name and password, and follow the 
procedures outlined in the guidance document for CDX available online 
at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf.
    2. Submission. Submitters choosing to submit electronically will 
use CISS to prepare their submissions. CISS guides users through a 
``hands-on'' process of creating an electronic submission. Once a user 
completes the relevant data fields and attaches appropriate PDF files 
or other file types, such as XML files, the web-based tool validates 
the submission by performing a basic error check and makes sure all the 
required fields and attachments are provided and complete.

[[Page 15331]]

Further instructions on submitting information and instructions for 
uploading PDF attachments or other file types, such as XML will be 
available through CISS reporting guidance available online at http://www.epa.gov/oppt/tsca8e/pubs/reportingrequirements.html#submitreport.

D. Can CBI be submitted using CISS?

    Yes, CISS enables the user to submit CBI in an electronic format. 
All information sent by the user via CDX is transmitted securely to 
protect CBI. CISS also guides the user through the process of 
submitting CBI by prompting the user to check a CBI checkbox if using a 
form or by submitting a scanned document containing CBI by bracketing, 
underlining, or otherwise marking the confidential information on the 
document prior to scanning. As with paper-based submissions, a 
sanitized copy of any document containing CBI would be included by the 
user in the electronic submission. The CISS reporting guidance 
instructs users on how to submit CBI and substantiate CBI claims 
information using CISS.

E. How will CBI be protected when submitting via CDX?

    The Agency ensures secure transmission of the data, reports, and 
other documents sent from the user through the Internet via the 
Transport Layer Security (TLS) 1.0 protocol. TLS 1.0 is a widely used 
approach for securing Internet transactions and is endorsed by the 
National Institute of Standards and Technology (NIST) as a means for 
protecting data sent over the Internet. See NIST Special Publication 
800-52, ``Guidelines for the Selection and Use of Transport Layer 
Security (TLS) Implementations,'' available online at http://csrc.nist.gov/publications/nistpubs/800-52/SP800-52.pdf.
    In addition, CISS enables the submitter to electronically sign, 
encrypt, and transmit submissions, which the Agency subsequently 
provides back to the user as an unaltered copy of record. This assures 
the user that the Agency has received exactly what the user sent to the 
Agency. CISS encrypts using a module based on the 256-bit Advanced 
Encryption Standard (AES) adopted by NIST. Details about AES can be 
found on the NIST Web site at http://csrc.nist.gov/publications/fips/fips197/fips-197.pdf. EPA may incorporate other encryption modules into 
future versions of CISS. Information submitted via CDX is processed 
within EPA by secure systems certified for compliance with Federal 
Information Processing Standards available online at http://www.nist.gov/itl/fips.cfm.

IV. References

    The following is a list of references that are specifically 
referenced in this document and placed in the docket that was 
established under docket ID number EPA-HQ-OPPT-2012-0159.

    1. EPA. Toxic Substance Control Act; Notification of Substantial 
Risk Under Section 8(e); Notice. Federal Register (43 FR 11110, 
March 16, 1978) (FRL-849-2).
    2. EPA. TSCA Section 8(e); Notification of Substantial Risk; 
Policy Clarification and Reporting Guidance; Notice. Federal 
Register (68 FR 33129, June 3, 2003) (FRL-7287-4).
    3. EPA. Cross-Media Electronic Reporting; Final Rule. Federal 
Register (70 FR 59848, October 13, 2005) (FRL-7977-1).
    4. EPA. TSCA Inventory Update Reporting Rule; Electronic 
Reporting, Direct final rule. Federal Register (71 FR 52494, 
September 6, 2006) (FRL-7752-8).
    5. EPA. TSCA Section 5 Premanufacture and Significant New Use 
Notification Electronic Reporting; Revisions to Notification 
Regulations; Final rule. Federal Register (75 FR 773, January 6, 
2010) (FRL-8794-5).
    6. EPA. TSCA Inventory Update Reporting Modifications; Chemical 
Data Reporting; Final rule. Federal Register (76 FR 50816, August 
16, 2011) (FRL-8872-9).
    7. EPA. Electronic Reporting Under the Toxic Substances Control 
Act; Proposed rule. Federal Register (77 FR 22707, April 17, 2012) 
(FRL-9337-5).

V. Statutory and Executive Order Reviews

    This action is not a regulation, nor does it impose any binding 
requirements. Submitters of TSCA section 8(e) notifications of 
substantial risk are not required to adopt the electronic reporting 
option described in this document in order to satisfy the statutory 
requirements. In addition, this action does not require anyone seeking 
to voluntarily submit information, including FYI submissions, to do so 
using an electronic reporting method.

A. Executive Order 12866 and Executive Order 13563

    This action is not a ``regulatory action'' as that term is defined 
in Executive Order 12866 entitled ``Regulatory Planning and Review'' 
(58 FR 51735, October 4, 1993). Therefore, it is not subject to review 
by under Executive Orders 12866 and 13563 entitled ``Improving 
Regulation and Regulatory Review'' (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    Pursuant to the Paperwork Reduction Act (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 collection of information unless it displays 
a currently valid Office of Management and Budget (OMB) control number. 
The OMB control numbers for EPA's regulations, after appearing in the 
Federal Register, are listed in 40 CFR part 9 and 48 CFR chapter 15, 
and included on the related collection instrument or form, if 
applicable.
    The information collection activities related to TSCA section 8(e) 
and FYI submissions, including the CDX registration activities 
associated with the electronic reporting option, have been approved by 
OMB under OMB control number 2070-0046 (EPA ICR No. 0794.13). The 
estimated burden of initial section 8(e) or FYI submissions is 51 hours 
per response when submitted in paper and 49 hours per response when 
submitted electronically. The estimated burden of follow-up/
supplemental section 8(e) or FYI submissions is 5 hours per response 
when submitted in paper and 4 hours per response when submitted 
electronically. The total annual burden approved by OMB is 18,518 
hours. Burden is defined in 5 CFR 1320.3(b).

C. Regulatory Flexibility Act

    Since this action is not a rule under the Administrative Procedure 
Act (5 U.S.C. 551(4)), and does 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.

D. Unfunded Mandates Reform Act and Executive Orders 13132 and 13175

    This action will not have substantial direct effects on State or 
tribal governments, on the relationship between the Federal Government 
and States or Indian Tribes, or on the distribution of power and 
responsibilities between the Federal Government and States or Indian 
Tribes. As a result, no action is required under Executive Order 13132, 
entitled ``Federalism'' (64 FR 43255, August 10, 1999), or under 
Executive Order 13175, entitled ``Consultation and Coordination with 
Indian Tribal Governments'' (65 FR 67249, November 9, 2000). Nor does 
it impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 
U.S.C. 1531-1538).

E. Executive Orders 13045, 13211, and 12898

    As indicated previously, this action is not a ``regulatory action'' 
as defined by Executive Order 12866. As a result, this action is not 
subject to Executive Order

[[Page 15332]]

13045, entitled ``Protection of Children from Environmental Health 
Risks and Safety Risks'' (62 FR 19885, April 23, 1997) and Executive 
Order 13211 entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001). In addition, this action also does not 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).

F. National Technology Transfer and Advancement Act

    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 (15 U.S.C. 272 note).

VI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq. does not apply 
because this action is not a rule as that term is defined in 5 U.S.C. 
804(3).

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Business and industry, Chemicals, Reporting and recordkeeping 
requirements.

    Dated: March 12, 2014.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2014-06050 Filed 3-18-14; 8:45 am]
BILLING CODE 6560-50-P