Document ID: EPA-HQ-OPPT-2017-0652-0003
Agency: epa
Document Type: Notice
Title: Guidance: Expanded Access to TSCA Confidential Business Information
Posted Date: 2018-03-16T04:00Z

[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11748-11750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05402]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0652; FRL-9974-82]
RIN 2070-ZA19

Draft Guidance on Expanded Access to TSCA Confidential Business 
Information; Notice of Availability and Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The amendments to the Toxic Substances Control Act in June 
2016 expand 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availability of and solicits comments on three draft guidance documents 
that address this requirement. These documents are available in the 
docket for public review and comment.

DATES: Comments must be received on or before April 16, 2018.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2017-0652, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: 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 draft 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 invites 
comment from prospective guidance users and other stakeholders 
concerning these draft guidance documents.

[[Page 11749]]

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 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 qualifies 
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.

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

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

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, amended 
TSCA section 14(d) 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); 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 entity who made the claim so 
requests, following the notification required under TSCA section 
14(g)(2)(C)(ii).

III. Draft Documents for Public Review

Draft Implementing Guidance

    The Agency developed three separate draft guidance documents 
corresponding to each of the new authorities in TSCA section 14(d)(4), 
(5), and (6). The conditions for access vary under each of the new 
provisions, but generally include the following: Requesters must show 
that they have a need for the information related to their employment, 
professional, or legal duties; recipients of TSCA CBI are 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); and except in emergency 
situations EPA must notify the entity that made the CBI claim at least 
15 days prior to disclosing the CBI. In addition, under these new 
provisions, requesters (except in some emergency situations) are 
required to sign an agreement and may be required to submit a statement 
of need to EPA. In accordance with the requirements of TSCA section 
14(c)(4)(B), each guidance document covers the content and form of the 
agreements and statements required under each provision and include 
information on where and how to submit requests to EPA.

IV. 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 draft guidance documents qualified as 
significant under Executive Order 12866 (58 FR 51735, October 4, 1993). 
As such, the draft 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

[[Page 11750]]

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 draft guidance and provides EPA's estimates for the 
related burden and costs. The ICR, after addressing comments received, 
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 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

    This action does not have tribal implications because it will not 
have any effect on tribal governments, on the relationship between the 
Federal government and the Indian tribes, or on the distribution of 
power and responsibilities between the Federal government and Indian 
tribes, as specified in Executive Order 13175 (65 FR 67249, November 9, 
2000).

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 proposing service fees for 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.

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

    Dated: March 12, 2018,
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical 
Safety and Pollution Prevention.
[FR Doc. 2018-05402 Filed 3-15-18; 8:45 am]
 BILLING CODE 6560-50-P