83_FR_30297 83 FR 30173 - Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting Under the Toxic Substances Control Act; Notice of Availability

83 FR 30173 - Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting Under the Toxic Substances Control Act; Notice of Availability

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 124 (June 27, 2018)

Page Range30173-30174
FR Document2018-13832

EPA is announcing the availability of the following guidance document: ``Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under TSCA.'' This guidance document, which is required by the Toxic Substances Control Act (TSCA), as amended in 2016 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, provides information to assist companies in creating structurally descriptive generic names for chemical substances whose specific chemical identities are claimed confidential, for the purposes of protecting the specific chemical identities from disclosure while describing the chemical substance as specifically as practicable, and for listing substances on the TSCA Chemical Substance Inventory.

Federal Register, Volume 83 Issue 124 (Wednesday, June 27, 2018)
[Federal Register Volume 83, Number 124 (Wednesday, June 27, 2018)]
[Notices]
[Pages 30173-30174]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13832]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0292; FRL-9979-02]


Guidance for Creating Generic Names for Confidential Chemical 
Substance Identity Reporting Under the Toxic Substances Control Act; 
Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is announcing the availability of the following guidance 
document: ``Guidance for Creating Generic Names for Confidential 
Chemical Substance Identity Reporting under TSCA.'' This guidance 
document, which is required by the Toxic Substances Control Act (TSCA), 
as amended in 2016 by the Frank R. Lautenberg Chemical Safety for the 
21st Century Act, provides information to assist companies in creating 
structurally descriptive generic names for chemical substances whose 
specific chemical identities are claimed confidential, for the purposes 
of protecting the specific chemical identities from disclosure while 
describing the chemical substance as specifically as practicable, and 
for listing substances on the TSCA Chemical Substance Inventory.

DATES: Submit comments on or before August 27, 2018.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2018-0292, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Tracy Williamson, Chemistry, 
Economics, and Sustainable Strategies Division (Mailcode 7406M), Office 
of Pollution Prevention and Toxics, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 564-8569; email address: tscainventory@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: 

[[Page 30174]]

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are a company 
needing assistance in creating structurally descriptive generic names 
for chemical substances whose specific chemical identities are claimed 
confidential, for purposes of protecting the specific chemical 
identities from disclosure and listing the substances on the TSCA 
Chemical Substance Inventory. This action may be of particular interest 
to entities that are regulated under TSCA (e.g., entities identified 
under North American Industrial Classification System (NAICS) codes 
324, 325, and 324110, among others). Since other entities also may be 
interested, the Agency has not attempted to describe all the specific 
entities and corresponding NAICS codes for entities that may be 
interested in or affected by this action.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

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

    The docket for this action, identified by docket identification 
(ID) number EPA-HQ-OPPT-2018-0292, is available online at http://www.regulations.gov or in person 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 that is available at http://www.epa.gov/dockets. You 
also will find this document and the ``Guidance for Creating Generic 
Names for Confidential Chemical Substance Identity Reporting under 
TSCA'' at http://www.epa.gov/tsca-inventory.

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

    As amended by the Frank R. Lautenberg Chemical Safety for the 21st 
Century Act in June 2016, TSCA section 14(c)(4), 15 U.S.C. 2613(c)(4), 
requires that EPA develop guidance regarding the determination of 
structurally descriptive generic names provided for chemical substances 
whose specific chemical identities have been claimed confidential in a 
TSCA notice. TSCA section 14(c)(1)(C) was amended to require submitters 
who assert a confidentiality claim for specific chemical identity to 
include a structurally descriptive generic name for the chemical 
substance that EPA may disclose to the public. The generic name must be 
consistent with EPA's guidance, and should describe the chemical 
structure of the substance as specifically as practicable while 
protecting those features of the chemical structure that are claimed as 
confidential and the disclosure of which would be likely to cause 
substantial harm to the competitive position of the claimant.

III. What action is the Agency taking?

    EPA is announcing the availability of the following guidance 
document: ``Guidance for Creating Generic Names for Confidential 
Chemical Substance Identity Reporting under TSCA.'' This guidance 
document is intended to assist companies in creating structurally 
descriptive generic names for chemical substances whose specific 
chemical identities are claimed confidential, for purposes of 
protecting the specific chemical identities from disclosure while 
describing the chemical substance as specifically as practicable, and 
for listing substances on the TSCA Chemical Substance Inventory.
    EPA previously published guidance to assist companies in creating 
structurally descriptive generic names in an appendix to the 1985 
publication of the TSCA Inventory (Appendix B, ``Generic Names for 
Confidential Chemical Substance Identities,'' in the ``TSCA Inventory, 
1985 Edition''). The new guidance document updates and replaces the 
1985 guidance. Consistent with TSCA section 14(c)(1)(C) and 14(c)(4) 
requirements, the updated guidance document provides more detail and 
clarity to companies regarding the approach for creating structurally 
descriptive generic names.
    As a nonbinding guidance document, this updated guidance document 
is a living document which may be revised periodically and without 
notice. In addition to seeking comments within the next 60 days, EPA 
welcomes public input on this guidance document at any time in the 
future.

    Authority: 15 U.S.C. 2613(c)(4).

    Dated: June 21, 2018.
E. Scott Pruitt,
Administrator.
[FR Doc. 2018-13832 Filed 6-26-18; 8:45 am]
 BILLING CODE 6560-50-P



                                                                            Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Notices                                            30173

                                               comment rulemaking requirements                         environmental health risks or safety                   SUMMARY:   EPA is announcing the
                                               under the Administrative Procedure Act                  risks.                                                 availability of the following guidance
                                               (APA), 5 U.S.C. 553, or any other                                                                              document: ‘‘Guidance for Creating
                                                                                                       H. Executive Order 13211: Actions
                                               statute. This action is not subject to the                                                                     Generic Names for Confidential
                                                                                                       Concerning Regulations That
                                               APA but is subject to TSCA, which does                                                                         Chemical Substance Identity Reporting
                                                                                                       Significantly Affect Energy Supply,
                                               not require notice and comment                                                                                 under TSCA.’’ This guidance document,
                                                                                                       Distribution, or Use
                                               rulemaking to take this action.                                                                                which is required by the Toxic
                                                                                                          This action is not a ‘‘significant                  Substances Control Act (TSCA), as
                                               D. Unfunded Mandates Reform Act                         energy action’’ as defined in Executive                amended in 2016 by the Frank R.
                                               (UMRA)                                                  Order 13211 (66 FR 28355, May 22,                      Lautenberg Chemical Safety for the 21st
                                                 This action does not contain an                       2001), because it is not likely to have a              Century Act, provides information to
                                               unfunded mandate of $100 million or                     significant adverse effect on energy                   assist companies in creating structurally
                                               more as described in UMRA, 2 U.S.C.                     supply, distribution, or use. This action              descriptive generic names for chemical
                                               1531–1538, and does not significantly or                is announcing the availability of                      substances whose specific chemical
                                               uniquely affect small governments. As                   guidance concerning obtaining access to                identities are claimed confidential, for
                                               such, the requirements of UMRA                          CBI under TSCA, which will not have                    the purposes of protecting the specific
                                               sections 202, 203, 204, or 205, 2 U.S.C.                a significant effect on the supply,                    chemical identities from disclosure
                                               1531–1538, do not apply to this action.                 distribution or use of energy.                         while describing the chemical substance
                                                                                                       I. National Technology Transfer and                    as specifically as practicable, and for
                                               E. Executive Order 13132: Federalism                                                                           listing substances on the TSCA
                                                                                                       Advancement Act (NTTAA)
                                                 This action does not have federalism                                                                         Chemical Substance Inventory.
                                               implications. It will not have substantial                Since this action does not involve any               DATES: Submit comments on or before
                                               direct effects on the States, on the                    technical standards, NTTAA section                     August 27, 2018.
                                               relationship between the national                       12(d) (15 U.S.C. 272 note) does not                    ADDRESSES: Submit your comments,
                                               government and the States, or on the                    apply to this action.                                  identified by docket identification (ID)
                                               distribution of power and                               J. Executive Order 12898: Federal                      number EPA–HQ–OPPT–2018–0292, by
                                               responsibilities among the various                      Actions To Address Environmental                       one of the following methods:
                                               levels of government, as specified in                   Justice in Minority Populations and                       • Federal eRulemaking Portal: http://
                                               Executive Order 13132 (64 FR 43255,                     Low-Income Populations                                 www.regulations.gov. Follow the online
                                               August 10, 1999).                                                                                              instructions for submitting comments.
                                                                                                          EPA believes that this action does not
                                               F. Executive Order 13175: Consultation                                                                         Do not submit electronically any
                                                                                                       have disproportionately high and
                                               and Coordination With Indian Tribal                                                                            information you consider to be
                                                                                                       adverse human health or environmental
                                               Governments                                                                                                    Confidential Business Information (CBI)
                                                                                                       effects on minority populations, low-
                                                                                                                                                              or other information whose disclosure is
                                                                                                       income populations and/or indigenous
                                                  Consistent with the EPA Policy on                                                                           restricted by statute.
                                                                                                       peoples, as specified in Executive Order                  • Mail: Document Control Office
                                               Consultation and Coordination with
                                                                                                       12898 (59 FR 7629, February 16, 1994).                 (7407M), Office of Pollution Prevention
                                               Indian Tribes, the EPA consulted with
                                                                                                       This action does not affect the level of               and Toxics (OPPT), Environmental
                                               tribal officials during the development
                                                                                                       protection provided to human health or                 Protection Agency, 1200 Pennsylvania
                                               of this action. EPA coordinated and
                                                                                                       the environment.                                       Ave. NW, Washington, DC 20460–0001.
                                               engaged with tribal partners early in the
                                               process during the development of the                   VI. Congressional Review Act                              • Hand Delivery: To make special
                                               guidance documents as well as                                                                                  arrangements for hand delivery or
                                                                                                         The Congressional Review Act, 5                      delivery of boxed information, please
                                               continued to conduct outreach to tribes                 U.S.C. 801 et seq. does not apply
                                               during the release of the draft guidance                                                                       follow the instructions at http://
                                                                                                       because this action is not a rule as that              www.epa.gov/dockets/contacts.html.
                                               documents. In addition, EPA held a                      term is defined in 5 U.S.C. 804(3).
                                               tribal consultation with tribes that                                                                              Additional instructions on
                                               requested further information. The                        Authority: 15 U.S.C. 2613(c).                        commenting or visiting the docket,
                                               Agency plans to continue to work with                     Dated: June 21, 2018.                                along with more information about
                                               our tribal partners to introduce the                    E. Scott Pruitt,                                       dockets generally, is available at http://
                                               guidance and provide a forum for open                                                                          www.epa.gov/dockets.
                                                                                                       Administrator.
                                               dialogue with tribes.                                                                                          FOR FURTHER INFORMATION CONTACT:
                                                                                                       [FR Doc. 2018–13828 Filed 6–26–18; 8:45 am]
                                                                                                                                                                 For technical information contact:
                                               G. Executive Order 13045: Protection of                 BILLING CODE 6560–50–P
                                                                                                                                                              Tracy Williamson, Chemistry,
                                               Children From Environmental Health                                                                             Economics, and Sustainable Strategies
                                               Risks and Safety Risks                                                                                         Division (Mailcode 7406M), Office of
                                                                                                       ENVIRONMENTAL PROTECTION
                                                 EPA interprets Executive Order 13045                                                                         Pollution Prevention and Toxics,
                                                                                                       AGENCY
                                               (62 FR 19885, April 23, 1997), as                                                                              Environmental Protection Agency, 1200
                                               applying only to those regulatory                       [EPA–HQ–OPPT–2018–0292; FRL–9979–02]                   Pennsylvania Ave. NW, Washington, DC
                                               actions that concern environmental                                                                             20460–0001; telephone number: (202)
                                               health or safety risks that EPA has                     Guidance for Creating Generic Names                    564–8569; email address:
                                               reason to believe may                                   for Confidential Chemical Substance                    tscainventory@epa.gov.
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                                               disproportionately affect children, per                 Identity Reporting Under the Toxic                        For general information contact: The
                                               the definition of ‘‘covered regulatory                  Substances Control Act; Notice of                      TSCA-Hotline, ABVI-Goodwill, 422
                                               action’’ in section 2–202 of Executive                  Availability                                           South Clinton Ave., Rochester, NY
                                               Order 13045. This action is not subject                                                                        14620; telephone number: (202) 554–
                                                                                                       AGENCY: Environmental Protection                       1404; email address: TSCA-Hotline@
                                               to Executive Order 13045 because it                     Agency (EPA).
                                               does not establish an environmental                                                                            epa.gov.
                                                                                                       ACTION: Notice.
                                               standard intended to mitigate                                                                                  SUPPLEMENTARY INFORMATION:



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                                               30174                        Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Notices

                                               I. General Information                                  legal holidays. The telephone number                   replaces the 1985 guidance. Consistent
                                                                                                       for the Public Reading Room is (202)                   with TSCA section 14(c)(1)(C) and
                                               A. Does this action apply to me?
                                                                                                       566–1744, and the telephone number for                 14(c)(4) requirements, the updated
                                                  You may be potentially affected by                   the OPPT Docket is (202) 566–0280.                     guidance document provides more
                                               this action if you are a company needing                Please review the visitor instructions                 detail and clarity to companies
                                               assistance in creating structurally                     and additional information about the                   regarding the approach for creating
                                               descriptive generic names for chemical                  docket that is available at http://                    structurally descriptive generic names.
                                               substances whose specific chemical                      www.epa.gov/dockets. You also will                        As a nonbinding guidance document,
                                               identities are claimed confidential, for                find this document and the ‘‘Guidance                  this updated guidance document is a
                                               purposes of protecting the specific                     for Creating Generic Names for                         living document which may be revised
                                               chemical identities from disclosure and                 Confidential Chemical Substance                        periodically and without notice. In
                                               listing the substances on the TSCA                      Identity Reporting under TSCA’’ at                     addition to seeking comments within
                                               Chemical Substance Inventory. This                      http://www.epa.gov/tsca-inventory.                     the next 60 days, EPA welcomes public
                                               action may be of particular interest to                                                                        input on this guidance document at any
                                               entities that are regulated under TSCA                  II. What is the Agency’s authority for
                                                                                                                                                              time in the future.
                                               (e.g., entities identified under North                  this action?
                                                                                                                                                                Authority: 15 U.S.C. 2613(c)(4).
                                               American Industrial Classification                         As amended by the Frank R.
                                               System (NAICS) codes 324, 325, and                      Lautenberg Chemical Safety for the 21st                  Dated: June 21, 2018.
                                               324110, among others). Since other                      Century Act in June 2016, TSCA section                 E. Scott Pruitt,
                                               entities also may be interested, the                    14(c)(4), 15 U.S.C. 2613(c)(4), requires               Administrator.
                                               Agency has not attempted to describe all                that EPA develop guidance regarding                    [FR Doc. 2018–13832 Filed 6–26–18; 8:45 am]
                                               the specific entities and corresponding                 the determination of structurally                      BILLING CODE 6560–50–P
                                               NAICS codes for entities that may be                    descriptive generic names provided for
                                               interested in or affected by this action.               chemical substances whose specific
                                                                                                       chemical identities have been claimed                  FEDERAL COMMUNICATIONS
                                               B. What should I consider as I prepare                  confidential in a TSCA notice. TSCA
                                               my comments for EPA?                                                                                           COMMISSION
                                                                                                       section 14(c)(1)(C) was amended to
                                                  1. Submitting CBI. Do not submit this                require submitters who assert a                        [OMB 3060–0349]
                                               information to EPA through                              confidentiality claim for specific
                                                                                                                                                              Information Collection Being Reviewed
                                               regulations.gov or email. Clearly mark                  chemical identity to include a
                                                                                                                                                              by the Federal Communications
                                               the part or all of the information that                 structurally descriptive generic name for
                                                                                                                                                              Commission
                                               you claim to be CBI. For CBI                            the chemical substance that EPA may
                                               information in a disk or CD–ROM that                    disclose to the public. The generic name               AGENCY: Federal Communications
                                               you mail to EPA, mark the outside of the                must be consistent with EPA’s guidance,                Commission.
                                               disk or CD–ROM as CBI and then                          and should describe the chemical                       ACTION: Notice and request for
                                               identify electronically within the disk or              structure of the substance as specifically             comments.
                                               CD–ROM the specific information that                    as practicable while protecting those
                                               is claimed as CBI. In addition to one                   features of the chemical structure that                SUMMARY:   As part of its continuing effort
                                               complete version of the comment that                    are claimed as confidential and the                    to reduce paperwork burdens, and as
                                               includes information claimed as CBI, a                  disclosure of which would be likely to                 required by the Paperwork Reduction
                                               copy of the comment that does not                       cause substantial harm to the                          Act of 1995 (PRA), the Federal
                                               contain the information claimed as CBI                  competitive position of the claimant.                  Communications Commission (FCC or
                                               must be submitted for inclusion in the                                                                         Commission) invites the general public
                                                                                                       III. What action is the Agency taking?                 and other Federal agencies to take this
                                               public docket. Information so marked
                                               will not be disclosed except in                            EPA is announcing the availability of               opportunity to comment on the
                                               accordance with procedures set forth in                 the following guidance document:                       following information collections.
                                               40 CFR part 2.                                          ‘‘Guidance for Creating Generic Names                  Comments are requested concerning:
                                                  2. Tips for preparing your comments.                 for Confidential Chemical Substance                    Whether the proposed collection of
                                               When preparing and submitting your                      Identity Reporting under TSCA.’’ This                  information is necessary for the proper
                                               comments, see the commenting tips at                    guidance document is intended to assist                performance of the functions of the
                                               http://www.epa.gov/dockets/                             companies in creating structurally                     Commission, including whether the
                                               comments.html.                                          descriptive generic names for chemical                 information shall have practical utility;
                                                                                                       substances whose specific chemical                     the accuracy of the Commission’s
                                               C. How can I get copies of this                         identities are claimed confidential, for               burden estimate; ways to enhance the
                                               document and other related                              purposes of protecting the specific                    quality, utility, and clarity of the
                                               information?                                            chemical identities from disclosure                    information collected; ways to minimize
                                                 The docket for this action, identified                while describing the chemical substance                the burden of the collection of
                                               by docket identification (ID) number                    as specifically as practicable, and for                information on the respondents,
                                               EPA–HQ–OPPT–2018–0292, is available                     listing substances on the TSCA                         including the use of automated
                                               online at http://www.regulations.gov or                 Chemical Substance Inventory.                          collection techniques or other forms of
                                               in person at the Office of Pollution                       EPA previously published guidance to                information technology; and ways to
                                               Prevention and Toxics Docket (OPPT                      assist companies in creating structurally              further reduce the information
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                                               Docket), Environmental Protection                       descriptive generic names in an                        collection burden on small business
                                               Agency Docket Center (EPA/DC), West                     appendix to the 1985 publication of the                concerns with fewer than 25 employees.
                                               William Jefferson Clinton Bldg., Rm.                    TSCA Inventory (Appendix B, ‘‘Generic                    The FCC may not conduct or sponsor
                                               3334, 1301 Constitution Ave. NW,                        Names for Confidential Chemical                        a collection of information unless it
                                               Washington, DC. The Public Reading                      Substance Identities,’’ in the ‘‘TSCA                  displays a currently valid Office of
                                               Room is open from 8:30 a.m. to 4:30                     Inventory, 1985 Edition’’). The new                    Management and Budget (OMB) control
                                               p.m., Monday through Friday, excluding                  guidance document updates and                          number. No person shall be subject to


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Document Created: 2018-11-06 09:52:41
Document Modified: 2018-11-06 09:52:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit comments on or before August 27, 2018.
ContactFor technical information contact: Tracy Williamson, Chemistry, Economics, and Sustainable Strategies Division (Mailcode 7406M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
FR Citation83 FR 30173 

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