Electronic Reporting; Toxic Substances Control Act Notifications of Substantial Risk and for Your Information Submissions, 15329-15332 [2014-06050]

Download as PDF sroberts on DSK5TPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Notices Applicants: KMC Thermo, LLC. Description: Market-Based Rate Application to be effective 5/16/2014. Filed Date: 3/12/14. Accession Number: 20140312–5042. Comments Due: 5 p.m. ET 4/2/14. Docket Numbers: ER14–1469–000. Applicants: PJM Interconnection, L.L.C. Description: Revisions to OA Sec 18.17 Permitting Sharing of Data with Gas Pipeline Operators to be effective 3/ 13/2014. Filed Date: 3/12/14. Accession Number: 20140312–5046. Comments Due: 5 p.m. ET 4/2/14. Docket Numbers: ER14–1470–000. Applicants: Midcontinent Independent System Operator, Inc. Description: 2014–03–11_SA 2645 Ameren-White Oak Facilities Service Agreement to be effective 5/11/2014. Filed Date: 3/12/14. Accession Number: 20140312–5156. Comments Due: 5 p.m. ET 4/2/14. Docket Numbers: ER14–1472–000. Applicants: Public Service Company of Colorado. Description: 2014–3–12_PSC–WAPA– T-Poncha SS PPA–358–0.0.0 to be effective 2/24/2014. Filed Date: 3/12/14. Accession Number: 20140312–5207. Comments Due: 5 p.m. ET 4/2/14. Docket Numbers: ER14–1473–000. Applicants: Central Maine Power Company. Description: Central Maine Power Company submits tariff filing per 35.13(a)(2)(iii: Amended Warren Interconnection Agreement to be effective 3/13/2014. Filed Date: 3/12/14. Accession Number: 20140312–5214. Comments Due: 5 p.m. ET 4/2/14. Take notice that the Commission received the following electric reliability filings. Docket Numbers: RD14–7–000. Applicants: North American Electric Reliability Corporation. Description: Petition of the North American Electric Reliability Corporation for Approval of Proposed Reliability Standard PER–005–2 and Retirement of Reliability Standard PER– 005–1. Filed Date: 3/7/14. Accession Number: 20140307–5142. Comments Due: 5 p.m. ET 4/11/14. The filings are accessible in the Commission’s eLibrary system by clicking on the links or querying the docket number. Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 VerDate Mar<15>2010 18:28 Mar 18, 2014 Jkt 232001 and 214 of the Commission’s Regulations (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding. eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/ docs-filing/efiling/filing-req.pdf. For other information, call (866) 208–3676 (toll free). For TTY, call (202) 502–8659. Dated: March 12, 2014. Nathaniel J. Davis, Sr., Deputy Secretary. [FR Doc. 2014–06038 Filed 3–18–14; 8:45 am] BILLING CODE 6717–01–P 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 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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. SUMMARY: SUPPLEMENTARY INFORMATION: PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 15329 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 E:\FR\FM\19MRN1.SGM 19MRN1 15330 Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Notices 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. sroberts on DSK5TPTVN1PROD with NOTICES 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: VerDate Mar<15>2010 18:28 Mar 18, 2014 Jkt 232001 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 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. E:\FR\FM\19MRN1.SGM 19MRN1 Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Notices 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/reporting requirements.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. sroberts on DSK5TPTVN1PROD with NOTICES 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/SP80052.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 VerDate Mar<15>2010 18:28 Mar 18, 2014 Jkt 232001 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 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 15331 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 E:\FR\FM\19MRN1.SGM 19MRN1 15332 Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Notices 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 ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–ORD–2014–0189; FRL–9908–30– ORD] Human Studies Review Board; Notification of a Public Meeting U.S. Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The Environmental Protection Agency (EPA) Office of the Science Advisor announces a public meeting of the Human Studies Review Board to advise the Agency on the EPA ethical and scientific reviews of research with human subjects. DATES: This public meeting will be held on April 8–9, 2014, from approximately 9:30 p.m. to approximately 5:30 p.m. Eastern Time. Comments may be sroberts on DSK5TPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:28 Mar 18, 2014 Jkt 232001 submitted on or before noon (Eastern Time) on Tuesday, April 1, 2014. ADDRESSES: The meeting will be held at the Environmental Protection Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202. Comments: Submit your written comments, identified by Docket ID No. EPA–HQ–ORD–2014–0189, by one of the following methods: Internet: http://www.regulations.gov: Follow the online instructions for submitting comments. Email: ORD.Docket@epa.gov. Mail: The EPA Docket Center EPA/ DC, ORD Docket, Mail code: 28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460. Hand Delivery: The EPA/DC Public Reading Room is located in the EPA Headquarters Library, Room Number 3334 in the EPA WJC West, at 1301 Constitution Avenue NW., Washington, DC 20460. The hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday, excluding federal holidays. Please call (202) 566– 1744 or email the ORD Docket at ord.docket@epa.gov for instructions. Updates to Public Reading Room access are available on the Web site http:// www.epa.gov/epahome/dockets.htm. Instructions: Direct your comments to Docket ID No. EPA–HQ–ORD–2014– 0189. The Agency’s policy is that all comments received will be included in the public docket without change and may be made available online at http:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information or other information the disclosure of which is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http:// www.regulations.gov or email. The http://www.regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through http:// www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any electronic storage media you submit. If the EPA cannot read your comment due to technical difficulties and cannot PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 contact you for clarification, the EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to receive further information should contact Jim Downing at telephone number (202) 564–2468; fax: (202) 564– 2070; email address: downing.jim@epa.gov; mailing address Environmental Protection Agency, Office of the Science Advisor, Mail code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC 20460. General information concerning the EPA HSRB can be found on the EPA Web site at http://www.epa.gov/hsrb. SUPPLEMENTARY INFORMATION: Meeting access: Seating at the meeting will be on a first-come basis. To request accommodation of a disability, please contact the persons listed under FOR FURTHER INFORMATION CONTACT at least ten business days prior to the meeting using the information under FOR FURTHER INFORMATION CONTACT, so that appropriate arrangements can be made. Procedures for providing public input: Interested members of the public may submit relevant written or oral comments for the HSRB to consider during the advisory process. Additional information concerning submission of relevant written or oral comments is provided in Section I, ‘‘Public Meeting’’ under subsection D. ‘‘How May I Participate in this Meeting?’’ of this notice. Webcast: This meeting may be webcast. Please refer to the HSRB Web site, http://www.epa.gov/hsrb/ for information on how to access the webcast. Please note that the webcast is a supplementary public process provided only for convenience. If difficulties arise resulting in webcasting outages, the meeting will continue as planned. I. Public Meeting A. Does this action apply to me? This action is directed to the public in general. This Notice may, however, be of particular interest to persons who conduct or assess human studies, especially studies on substances regulated by the EPA, or to persons who are, or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act or the Federal Insecticide, Fungicide, and Rodenticide Act. This notice might also be of special interest to participants of studies involving human subjects, or representatives of study participants or E:\FR\FM\19MRN1.SGM 19MRN1

Agencies

[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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