83_FR_30295 83 FR 30171 - Guidance on Expanded Access to TSCA Confidential Business Information; Notice of Availability

83 FR 30171 - Guidance on Expanded Access to TSCA Confidential Business Information; Notice of Availability

ENVIRONMENTAL PROTECTION AGENCY

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

Page Range30171-30173
FR Document2018-13828

The amendments to the Toxic Substances Control Act in June 2016 expanded the categories of people to whom EPA may disclose TSCA confidential business information (CBI) by specifically authorizing EPA to disclose TSCA CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders, under certain conditions, including consistency with guidance that EPA is required to develop. This document announces the availability of three guidance documents that address this requirement.

Federal Register, Volume 83 Issue 124 (Wednesday, June 27, 2018)
[Federal Register Volume 83, Number 124 (Wednesday, June 27, 2018)]
[Notices]
[Pages 30171-30173]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13828]


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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0652; FRL-9979-75]


Guidance on Expanded Access to TSCA Confidential Business 
Information; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The amendments to the Toxic Substances Control Act in June 
2016 expanded the categories of people to whom EPA may disclose TSCA 
confidential business information (CBI) by specifically authorizing EPA 
to disclose TSCA CBI to state, tribal, and local governments; 
environmental, health, and medical professionals; and emergency 
responders, under certain conditions, including consistency with 
guidance that EPA is required to develop. This document announces the 
availability of three guidance documents that address this requirement.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Jessica Barkas, Environmental 
Assistance Division, Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 250-8880; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. What action is EPA taking?

    As directed by TSCA, EPA has developed guidance for each of three 
new expanded TSCA CBI access provisions. The guidance documents cover 
the content and form of the agreements and statements of need required 
under each provision, and include some basic logistical information on 
where and how to submit requests to EPA.
    EPA maintains a list of Significant Guidance Documents at http://www.epa.gov/regulations/guidance/ as called for by the Office of 
Management and Budget's (OMB) Final Bulletin for Agency Good Guidance 
Practices (https://www.thefederalregister.org/fdsys/pkg/FR-2007-01-25/pdf/E7-1066.pdf). Please be aware that the EPA list of Significant Guidance 
Documents does not include every guidance document issued by EPA and 
only encompasses those documents that are ``significant'' as defined by 
OMB's Bulletin.
    These final documents have been determined to be EPA Significant 
Guidance Documents per the OMB Bulletin definition and are included on 
the EPA list of significant guidance documents. OMB's Bulletin directs 
agencies to allow for the public to submit comments on any Significant 
Guidance Document that appears on the Agency's list of significant 
guidance documents. EPA allows for public comments to be submitted 
through the Agency's electronic docket and commenting system at http://www.regulations.gov. Please note that although you may receive an 
acknowledgement that EPA has received your comment, you may not receive 
a detailed response to your comment. Your feedback is nevertheless 
important to EPA and will be forwarded to the appropriate program for 
consideration.

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

    TSCA section 14(c)(4)(B) requires that EPA develop guidance 
concerning the ``content and form of the statements of need and 
agreements required'' under TSCA section 14(d)(4), (5), and (6). 15 
U.S.C. 2613.

C. Does this action apply to me?

    You may be potentially affected by this action if you are a state, 
tribal, or local government, or are employed by a

[[Page 30172]]

government (federal, state, local, or tribal) or in the private sector 
and your duties concern: Chemical regulation; chemical-related law 
enforcement; diagnosing or treating chemical exposures; and/or chemical 
spill, incident, accident, or emergency response, including injury to 
humans or the environment. You may also be affected by this action if 
you have or may in the future submit information to EPA that you claim 
as TSCA CBI.

D. What are the potential incremental economic impacts of taking this 
action?

    The potential incremental economic impacts that are associated with 
the information collection activities contained in the guidance 
documents are enumerated in the Information Collection Request (ICR) 
entitled ``Guidance on Expanded Access to TSCA Confidential Business 
Information'' (EPA ICR No. 2570.01 and OMB Control No. 2070-(new)), 
which published in the Federal Register on March 12, 2018 (83 FR 10719) 
(FRL-9975-24). The annual public reporting and recordkeeping burden for 
this collection of information is estimated to average 14.8 hours and 
cost about $868 per response. The comment period closed on May 11, 
2018. No comments were received.

II. Background

    Enacted on June 22, 2016, the Frank R. Lautenberg Chemical Safety 
for the 21st Century Act (Pub. L. 114-182), changed and expanded many 
parts of TSCA (15 U.S.C. 2601 et seq.). Among these changes, TSCA 
section 14(d) as amended expands the categories of people who may now 
access TSCA CBI. TSCA CBI is information submitted to EPA under TSCA, 
for which a business has made a claim of business confidentiality which 
has not been withdrawn by the business, expired, or denied by EPA. 
There are three new provisions expanding access to CBI, each under 
certain conditions:
     Under TSCA section 14(d)(4), 15 U.S.C. 2613(d)(4), EPA may 
disclose CBI to state, tribal, and local governments;
     Under TSCA section 14(d)(5), 15 U.S.C. 2613(d)(5), EPA 
may, in non-emergency situations, disclose CBI to a health or 
environmental professional employed by a Federal or state agency or 
tribal government, or to a treating physician or nurse; and
     Under TSCA section 14(d)(6), 15 U.S.C. 2613(d)(6), EPA 
may, in the event of an emergency, disclose CBI to a treating or 
responding physician, nurse, agent of a poison control center, public 
health or environmental official of a state, political subdivision of a 
state, or tribal government, or to a first responder (including any 
individual duly authorized by a Federal agency, state, political 
subdivision of a state, or tribal government who is trained in urgent 
medical care or other emergency procedures, including a police officer, 
firefighter, or emergency medical technician).
    The conditions for access vary under each of the new provisions, 
but generally include the following;
     The requester must show that he or she has a need for the 
information related to their employment, professional, or legal duties;
     The recipient of TSCA CBI is prohibited from disclosing or 
permitting further disclosure of the information to individuals not 
authorized to receive it (physicians/nurses may disclose the 
information to their patient or person authorized to make medical or 
health care decisions on behalf of the patient); and
     EPA generally must notify the entity that made the CBI 
claim at least 15 days prior to disclosing the CBI. There is an 
exception for disclosures in emergency situations, which require that 
EPA make the notification as soon as practicable (see TSCA section 
14(g)(2)(C)(ii)).
    In addition, under these new provisions, requesters are generally 
required to sign an agreement and may be required to submit a statement 
of need to EPA. Emergency requestors only need to sign an agreement and 
submit a statement of need if the person who made the claim so 
requests, following the notification required under TSCA section 
14(g)(2)(C)(ii).

III. Response to Public Comments

    EPA previously collected public comment on draft versions of the 
three guidance documents (83 FR 11748 (March 16, 2018)). Thirteen 
relevant comments were received, from state governments and government 
organizations (3), tribal governments (2), industry (3), a utility 
group (1), a fire fighters' organization (1), and medical, health and 
environmental groups (3). Most commentary on the guidance documents 
concerned EPA's request processing time; the scope of some definitions 
in the 14(d)(5) and (d)(6) documents; requested additional means 
through which to request or access information; suggested revisions to 
a provision in the confidentiality agreements included in the 14(d)(5) 
and (d)(6) documents; or requested that EPA establish a contact 
available for emergency requests after business hours. A Response to 
Comments document is available in the docket for this action.

IV. References

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

EPA. 2018. Response to Comment Document for TSCA Section 14(d) 
Guidance Documents.

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    OMB has determined that these guidance documents qualify as 
significant under Executive Order 12866 (58 FR 51735, October 4, 1993). 
As such, the documents were submitted to OMB for review under Executive 
Orders 12866 and 13563 (76 FR 3821, January 21, 2011). Any changes to 
the documents that were made in response to OMB recommendations have 
been documented in the docket for this action as required by section 
6(a)(3)(E) of Executive Order 12866.

B. Paperwork Reduction Act (PRA)

    In the Federal Register on March 12, 2018 (83 FR 10719) (FRL-9975-
24), EPA announced the availability of and solicited comment on the 
draft ICR entitled ``Guidance on Expanded Access to TSCA Confidential 
Business Information'' (EPA ICR No. 2570.01 and OMB Control No. 2070-
(new)). The ICR identifies the information collection activities 
contained in the guidance and provides EPA's estimates for the related 
burden and costs. The comment period closed on May 11, 2018. No 
comments were received. The final ICR will be submitted to OMB for 
review and approval under the PRA, 44 U.S.C. 3501 et seq.

C. Regulatory Flexibility Act (RFA)

    This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA 
applies only to rules subject to notice and

[[Page 30173]]

comment rulemaking requirements under the Administrative Procedure Act 
(APA), 5 U.S.C. 553, or any other statute. This action is not subject 
to the APA but is subject to TSCA, which does not require notice and 
comment rulemaking to take this action.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. As such, the 
requirements of UMRA sections 202, 203, 204, or 205, 2 U.S.C. 1531-
1538, do not apply to this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government, as 
specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    Consistent with the EPA Policy on Consultation and Coordination 
with Indian Tribes, the EPA consulted with tribal officials during the 
development of this action. EPA coordinated and engaged with tribal 
partners early in the process during the development of the guidance 
documents as well as continued to conduct outreach to tribes during the 
release of the draft guidance documents. In addition, EPA held a tribal 
consultation with tribes that requested further information. The Agency 
plans to continue to work with our tribal partners to introduce the 
guidance and provide a forum for open dialogue with tribes.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), 
as applying only to those regulatory actions that concern environmental 
health or safety risks that EPA has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of Executive Order 13045. This 
action is not subject to Executive Order 13045 because it does not 
establish an environmental standard intended to mitigate environmental 
health risks or safety risks.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not 
likely to have a significant adverse effect on energy supply, 
distribution, or use. This action is announcing the availability of 
guidance concerning obtaining access to CBI under TSCA, which will not 
have a significant effect on the supply, distribution or use of energy.

I. National Technology Transfer and Advancement Act (NTTAA)

    Since this action does not involve any technical standards, NTTAA 
section 12(d) (15 U.S.C. 272 note) does not apply to this action.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    EPA believes that this action does not have disproportionately high 
and adverse human health or environmental effects on minority 
populations, low-income populations and/or indigenous peoples, as 
specified in Executive Order 12898 (59 FR 7629, February 16, 1994). 
This action does not affect the level of protection provided to human 
health or the environment.

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).

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

    Dated: June 21, 2018.
E. Scott Pruitt,
Administrator.
[FR Doc. 2018-13828 Filed 6-26-18; 8:45 am]
BILLING CODE 6560-50-P



                                                                            Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Notices                                             30171

                                               and/or other identifiers). These                        the first annual list on EPA’s internet                South Clinton Ave., Rochester, NY
                                               documents would be reviewed for                         site in November of 2018.                              14620; telephone number: (202) 554–
                                               relevance (i.e., to ensure that they are                                                                       1404; email address: TSCA-Hotline@
                                                                                                       VI. References
                                               not mislabeled with the wrong CASRN                                                                            epa.gov.
                                               or PMN number), then searched for                         The following is a listing of the
                                                                                                                                                              SUPPLEMENTARY INFORMATION:
                                               mention of the confidential specific                    documents that are specifically
                                               chemical identity that is protected by                  referenced in this document. The docket                I. Executive Summary
                                               the UID (e.g., CASRN and/or specific                    includes these documents and other
                                                                                                                                                              A. What action is EPA taking?
                                               chemical name).                                         information considered by EPA,
                                                  Any relevant documents that do not                   including documents that are referenced                   As directed by TSCA, EPA has
                                               reveal the confidential specific chemical               within the documents that are included                 developed guidance for each of three
                                               identity in the public version would be                 in the docket, even if the referenced                  new expanded TSCA CBI access
                                               labeled with the UID. Any relevant                      document is not physically located in                  provisions. The guidance documents
                                               documents that mention this                             the docket. For assistance in locating                 cover the content and form of the
                                               confidential specific chemical identity                 these other documents, please consult                  agreements and statements of need
                                               in the public version would be set aside                the person listed under FOR FURTHER                    required under each provision, and
                                               for additional screening. EPA                           INFORMATION CONTACT.                                   include some basic logistical
                                               anticipates that documents in the latter                1. EPA. 2018. Response to Comment
                                                                                                                                                              information on where and how to
                                               category will be fairly rare. Documents                     Document for Unique Identifier                     submit requests to EPA.
                                               subject to additional screening would be                    Assignment and Application Policy.                    EPA maintains a list of Significant
                                               examined for information indicating                                                                            Guidance Documents at http://
                                                                                                         Authority: 15 U.S.C. 2613.
                                               that the confidential TSCA Inventory                                                                           www.epa.gov/regulations/guidance/ as
                                               status may no longer be warranted (e.g.,                  Dated: June 21, 2018.                                called for by the Office of Management
                                               if the document reveals to the public                   E. Scott Pruitt,                                       and Budget’s (OMB) Final Bulletin for
                                               that the chemical substance is offered                  Administrator, Environmental Protection                Agency Good Guidance Practices
                                               for commercial distribution in the                      Agency.                                                (https://www.gpo.gov/fdsys/pkg/FR-
                                               United States for TSCA uses). If there is               [FR Doc. 2018–13829 Filed 6–26–18; 8:45 am]            2007-01-25/pdf/E7-1066.pdf). Please be
                                               no such public information                              BILLING CODE 6560–50–P                                 aware that the EPA list of Significant
                                               undermining the approved CBI claim,                                                                            Guidance Documents does not include
                                               then the UID would not be applied to                                                                           every guidance document issued by
                                               this document. The document would                       ENVIRONMENTAL PROTECTION                               EPA and only encompasses those
                                               continue to be available to the public,                 AGENCY                                                 documents that are ‘‘significant’’ as
                                               and continue to include reference to the                [EPA–HQ–OPPT–2017–0652; FRL–9979–75]                   defined by OMB’s Bulletin.
                                               confidential chemical identity, but it                                                                            These final documents have been
                                               would not be labeled with the UID.                      Guidance on Expanded Access to                         determined to be EPA Significant
                                                  If the result of the additional                      TSCA Confidential Business                             Guidance Documents per the OMB
                                               screening is that the chemical identity                 Information; Notice of Availability                    Bulletin definition and are included on
                                               CBI claim appears no longer valid (i.e.,                                                                       the EPA list of significant guidance
                                               EPA develops a reasonable basis to                      AGENCY: Environmental Protection                       documents. OMB’s Bulletin directs
                                               believe that the information no longer                  Agency (EPA).                                          agencies to allow for the public to
                                               qualifies for protection from disclosure)               ACTION: Notice.                                        submit comments on any Significant
                                               or appears to have been withdrawn (for                                                                         Guidance Document that appears on the
                                               example, where a subsequent                             SUMMARY:   The amendments to the Toxic
                                                                                                                                                              Agency’s list of significant guidance
                                               submission by the original claimant                     Substances Control Act in June 2016
                                                                                                                                                              documents. EPA allows for public
                                               does not claim the specific chemical                    expanded the categories of people to
                                                                                                                                                              comments to be submitted through the
                                               identity as CBI), EPA will proceed in                   whom EPA may disclose TSCA
                                                                                                                                                              Agency’s electronic docket and
                                               accordance with section 14(f)(2)(B) and/                confidential business information (CBI)
                                                                                                                                                              commenting system at http://
                                               or 14(e)(1)(B)(ii), as appropriate.                     by specifically authorizing EPA to
                                                                                                                                                              www.regulations.gov. Please note that
                                               Consistent with section 14(g)(4)(D),                    disclose TSCA CBI to state, tribal, and
                                                                                                                                                              although you may receive an
                                               whenever a claim for protection of a                    local governments; environmental,
                                                                                                                                                              acknowledgement that EPA has received
                                               specific chemical identity for which a                  health, and medical professionals; and
                                                                                                                                                              your comment, you may not receive a
                                               UID has been assigned is subsequently                   emergency responders, under certain
                                                                                                                                                              detailed response to your comment.
                                               denied by EPA, is withdrawn by the                      conditions, including consistency with
                                                                                                                                                              Your feedback is nevertheless important
                                               claimant, or expires, EPA will, to the                  guidance that EPA is required to
                                                                                                                                                              to EPA and will be forwarded to the
                                               extent practicable, clearly link the                    develop. This document announces the
                                                                                                                                                              appropriate program for consideration.
                                               specific chemical identity to the UID in                availability of three guidance
                                               information that EPA has made public.                   documents that address this                            B. What is the Agency’s authority for
                                                                                                       requirement.                                           taking this action?
                                               V. Annual UID List
                                                                                                       FOR FURTHER INFORMATION CONTACT:                          TSCA section 14(c)(4)(B) requires that
                                                  Under TSCA section 14(g)(4)(B), EPA                     For technical information contact:                  EPA develop guidance concerning the
                                               is required to ‘‘annually publish and                   Jessica Barkas, Environmental                          ‘‘content and form of the statements of
                                               update a list of chemical substances,                   Assistance Division, Office of Pollution               need and agreements required’’ under
daltland on DSKBBV9HB2PROD with NOTICES




                                               referred to by their unique identifiers,                Prevention and Toxics, Environmental                   TSCA section 14(d)(4), (5), and (6). 15
                                               for which claims to protect the specific                Protection Agency, 1200 Pennsylvania                   U.S.C. 2613.
                                               chemical identity from disclosure have                  Ave. NW, Washington, DC 20460–0001;
                                               been approved, including the expiration                 telephone number: (202) 250–8880;                      C. Does this action apply to me?
                                               date for each such claim.’’ EPA will be                 email address: barkas.jessica@epa.gov.                   You may be potentially affected by
                                               using the approach announced in this                       For general information contact: The                this action if you are a state, tribal, or
                                               document and anticipates publishing                     TSCA-Hotline, ABVI-Goodwill, 422                       local government, or are employed by a


                                          VerDate Sep<11>2014   16:58 Jun 26, 2018   Jkt 244001   PO 00000   Frm 00077   Fmt 4703   Sfmt 4703   E:\FR\FM\27JNN1.SGM   27JNN1


                                               30172                        Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Notices

                                               government (federal, state, local, or                   tribal government, or to a first responder             document is available in the docket for
                                               tribal) or in the private sector and your               (including any individual duly                         this action.
                                               duties concern: Chemical regulation;                    authorized by a Federal agency, state,
                                                                                                                                                              IV. References
                                               chemical-related law enforcement;                       political subdivision of a state, or tribal
                                               diagnosing or treating chemical                         government who is trained in urgent                      The following is a listing of the
                                               exposures; and/or chemical spill,                       medical care or other emergency                        documents that are specifically
                                               incident, accident, or emergency                        procedures, including a police officer,                referenced in this document. The docket
                                               response, including injury to humans or                 firefighter, or emergency medical                      includes these documents and other
                                               the environment. You may also be                        technician).                                           information considered by EPA,
                                               affected by this action if you have or                     The conditions for access vary under                including documents that are referenced
                                               may in the future submit information to                 each of the new provisions, but                        within the documents that are included
                                               EPA that you claim as TSCA CBI.                         generally include the following;                       in the docket, even if the referenced
                                                                                                          • The requester must show that he or                document is not physically located in
                                               D. What are the potential incremental                                                                          the docket. For assistance in locating
                                               economic impacts of taking this action?                 she has a need for the information
                                                                                                       related to their employment,                           these other documents, please consult
                                                  The potential incremental economic                   professional, or legal duties;                         the person listed under FOR FURTHER
                                               impacts that are associated with the                                                                           INFORMATION CONTACT.
                                                                                                          • The recipient of TSCA CBI is
                                               information collection activities
                                                                                                       prohibited from disclosing or permitting               EPA. 2018. Response to Comment Document
                                               contained in the guidance documents                                                                               for TSCA Section 14(d) Guidance
                                                                                                       further disclosure of the information to
                                               are enumerated in the Information                                                                                 Documents.
                                                                                                       individuals not authorized to receive it
                                               Collection Request (ICR) entitled
                                                                                                       (physicians/nurses may disclose the                    V. Statutory and Executive Order
                                               ‘‘Guidance on Expanded Access to
                                                                                                       information to their patient or person                 Reviews
                                               TSCA Confidential Business
                                                                                                       authorized to make medical or health
                                               Information’’ (EPA ICR No. 2570.01 and                                                                           Additional information about these
                                                                                                       care decisions on behalf of the patient);
                                               OMB Control No. 2070-(new)), which                                                                             statutes and Executive Orders can be
                                                                                                       and
                                               published in the Federal Register on                                                                           found at https://www.epa.gov/laws-
                                               March 12, 2018 (83 FR 10719) (FRL–                         • EPA generally must notify the
                                                                                                                                                              regulations/laws-and-executive-orders.
                                               9975–24). The annual public reporting                   entity that made the CBI claim at least
                                               and recordkeeping burden for this                       15 days prior to disclosing the CBI.                   A. Executive Order 12866: Regulatory
                                               collection of information is estimated to               There is an exception for disclosures in               Planning and Review and Executive
                                               average 14.8 hours and cost about $868                  emergency situations, which require                    Order 13563: Improving Regulation and
                                               per response. The comment period                        that EPA make the notification as soon                 Regulatory Review
                                               closed on May 11, 2018. No comments                     as practicable (see TSCA section                         OMB has determined that these
                                               were received.                                          14(g)(2)(C)(ii)).                                      guidance documents qualify as
                                                                                                          In addition, under these new                        significant under Executive Order 12866
                                               II. Background                                          provisions, requesters are generally                   (58 FR 51735, October 4, 1993). As such,
                                                  Enacted on June 22, 2016, the Frank                  required to sign an agreement and may                  the documents were submitted to OMB
                                               R. Lautenberg Chemical Safety for the                   be required to submit a statement of                   for review under Executive Orders
                                               21st Century Act (Pub. L. 114–182),                     need to EPA. Emergency requestors only                 12866 and 13563 (76 FR 3821, January
                                               changed and expanded many parts of                      need to sign an agreement and submit                   21, 2011). Any changes to the
                                               TSCA (15 U.S.C. 2601 et seq.). Among                    a statement of need if the person who                  documents that were made in response
                                               these changes, TSCA section 14(d) as                    made the claim so requests, following                  to OMB recommendations have been
                                               amended expands the categories of                       the notification required under TSCA                   documented in the docket for this action
                                               people who may now access TSCA CBI.                     section 14(g)(2)(C)(ii).                               as required by section 6(a)(3)(E) of
                                               TSCA CBI is information submitted to                    III. Response to Public Comments                       Executive Order 12866.
                                               EPA under TSCA, for which a business
                                               has made a claim of business                               EPA previously collected public                     B. Paperwork Reduction Act (PRA)
                                               confidentiality which has not been                      comment on draft versions of the three                    In the Federal Register on March 12,
                                               withdrawn by the business, expired, or                  guidance documents (83 FR 11748                        2018 (83 FR 10719) (FRL–9975–24),
                                               denied by EPA. There are three new                      (March 16, 2018)). Thirteen relevant                   EPA announced the availability of and
                                               provisions expanding access to CBI,                     comments were received, from state                     solicited comment on the draft ICR
                                               each under certain conditions:                          governments and government                             entitled ‘‘Guidance on Expanded Access
                                                  • Under TSCA section 14(d)(4), 15                    organizations (3), tribal governments (2),             to TSCA Confidential Business
                                               U.S.C. 2613(d)(4), EPA may disclose CBI                 industry (3), a utility group (1), a fire              Information’’ (EPA ICR No. 2570.01 and
                                               to state, tribal, and local governments;                fighters’ organization (1), and medical,               OMB Control No. 2070-(new)). The ICR
                                                  • Under TSCA section 14(d)(5), 15                    health and environmental groups (3).                   identifies the information collection
                                               U.S.C. 2613(d)(5), EPA may, in non-                     Most commentary on the guidance                        activities contained in the guidance and
                                               emergency situations, disclose CBI to a                 documents concerned EPA’s request                      provides EPA’s estimates for the related
                                               health or environmental professional                    processing time; the scope of some                     burden and costs. The comment period
                                               employed by a Federal or state agency                   definitions in the 14(d)(5) and (d)(6)                 closed on May 11, 2018. No comments
                                               or tribal government, or to a treating                  documents; requested additional means                  were received. The final ICR will be
                                               physician or nurse; and                                 through which to request or access                     submitted to OMB for review and
daltland on DSKBBV9HB2PROD with NOTICES




                                                  • Under TSCA section 14(d)(6), 15                    information; suggested revisions to a                  approval under the PRA, 44 U.S.C. 3501
                                               U.S.C. 2613(d)(6), EPA may, in the event                provision in the confidentiality                       et seq.
                                               of an emergency, disclose CBI to a                      agreements included in the 14(d)(5) and
                                               treating or responding physician, nurse,                (d)(6) documents; or requested that EPA                C. Regulatory Flexibility Act (RFA)
                                               agent of a poison control center, public                establish a contact available for                        This action is not subject to the RFA,
                                               health or environmental official of a                   emergency requests after business                      5 U.S.C. 601 et seq. The RFA applies
                                               state, political subdivision of a state, or             hours. A Response to Comments                          only to rules subject to notice and


                                          VerDate Sep<11>2014   16:58 Jun 26, 2018   Jkt 244001   PO 00000   Frm 00078   Fmt 4703   Sfmt 4703   E:\FR\FM\27JNN1.SGM   27JNN1


                                                                            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.
daltland on DSKBBV9HB2PROD with NOTICES




                                               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:



                                          VerDate Sep<11>2014   16:58 Jun 26, 2018   Jkt 244001   PO 00000   Frm 00079   Fmt 4703   Sfmt 4703   E:\FR\FM\27JNN1.SGM   27JNN1



Document Created: 2018-11-06 09:53:15
Document Modified: 2018-11-06 09:53:15
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.
ContactFor technical information contact: Jessica Barkas, Environmental Assistance Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
FR Citation83 FR 30171 

2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR