Guidance on Expanded Access to TSCA Confidential Business Information; Notice of Availability, 30171-30173 [2018-13828]

Download as PDF Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Notices daltland on DSKBBV9HB2PROD with NOTICES and/or other identifiers). These documents would be reviewed for relevance (i.e., to ensure that they are not mislabeled with the wrong CASRN or PMN number), then searched for mention of the confidential specific chemical identity that is protected by the UID (e.g., CASRN and/or specific chemical name). Any relevant documents that do not reveal the confidential specific chemical identity in the public version would be labeled with the UID. Any relevant documents that mention this confidential specific chemical identity in the public version would be set aside for additional screening. EPA anticipates that documents in the latter category will be fairly rare. Documents subject to additional screening would be examined for information indicating that the confidential TSCA Inventory status may no longer be warranted (e.g., if the document reveals to the public that the chemical substance is offered for commercial distribution in the United States for TSCA uses). If there is no such public information undermining the approved CBI claim, then the UID would not be applied to this document. The document would continue to be available to the public, and continue to include reference to the confidential chemical identity, but it would not be labeled with the UID. If the result of the additional screening is that the chemical identity CBI claim appears no longer valid (i.e., EPA develops a reasonable basis to believe that the information no longer qualifies for protection from disclosure) or appears to have been withdrawn (for example, where a subsequent submission by the original claimant does not claim the specific chemical identity as CBI), EPA will proceed in accordance with section 14(f)(2)(B) and/ or 14(e)(1)(B)(ii), as appropriate. Consistent with section 14(g)(4)(D), whenever a claim for protection of a specific chemical identity for which a UID has been assigned is subsequently denied by EPA, is withdrawn by the claimant, or expires, EPA will, to the extent practicable, clearly link the specific chemical identity to the UID in information that EPA has made public. V. Annual UID List Under TSCA section 14(g)(4)(B), EPA is required to ‘‘annually publish and update a list of chemical substances, referred to by their unique identifiers, for which claims to protect the specific chemical identity from disclosure have been approved, including the expiration date for each such claim.’’ EPA will be using the approach announced in this document and anticipates publishing VerDate Sep<11>2014 16:58 Jun 26, 2018 Jkt 244001 the first annual list on EPA’s internet site in November of 2018. VI. 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. 1. EPA. 2018. Response to Comment Document for Unique Identifier Assignment and Application Policy. Authority: 15 U.S.C. 2613. Dated: June 21, 2018. E. Scott Pruitt, Administrator, Environmental Protection Agency. [FR Doc. 2018–13829 Filed 6–26–18; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2017–0652; FRL–9979–75] Guidance on Expanded Access to TSCA Confidential Business Information; Notice of Availability Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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: barkas.jessica@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 SUMMARY: PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 30171 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. 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 https:// 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.gpo.gov/fdsys/pkg/FR2007-01-25/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 https:// 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 E:\FR\FM\27JNN1.SGM 27JNN1 30172 Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Notices 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. daltland on DSKBBV9HB2PROD with NOTICES 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 nonemergency 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 VerDate Sep<11>2014 16:58 Jun 26, 2018 Jkt 244001 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 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 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/lawsregulations/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 E:\FR\FM\27JNN1.SGM 27JNN1 Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Notices 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. daltland on DSKBBV9HB2PROD with NOTICES 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 VerDate Sep<11>2014 16:58 Jun 26, 2018 Jkt 244001 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, lowincome 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 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 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 30173 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: https:// 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 https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// 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: SUMMARY: E:\FR\FM\27JNN1.SGM 27JNN1

Agencies

[Federal Register Volume 83, Number 124 (Wednesday, June 27, 2018)]
[Notices]
[Pages 30171-30173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://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.gpo.gov/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 https://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
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