Document ID: EPA-HQ-OPPT-2017-0652-0023
Agency: epa
Document Type: Notice
Title: Guidance: Expanded Access to TSCA Confidential Business Information
Posted Date: 2018-06-27T04:00Z

[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]

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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.

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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.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 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

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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]
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