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

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CBI claim appears no longer valid (i.e., 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or appears to have been withdrawn (for 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denied by EPA, is withdrawn by the 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 

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 

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: barkas.jessica@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: 

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/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 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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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. 

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 

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/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 


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

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: EPA is announcing the 

availability of the following guidance 

document: ‘‘Guidance for Creating 

Generic Names for Confidential 

Chemical Substance Identity Reporting 

under TSCA.’’ This guidance document, 

which is required by the Toxic 

Substances Control Act (TSCA), as 

amended in 2016 by the Frank R. 

Lautenberg Chemical Safety for the 21st 

Century Act, provides information to 

assist companies in creating structurally 

descriptive generic names for chemical 

substances whose specific chemical 

identities are claimed confidential, for 

the purposes of protecting the specific 

chemical identities from disclosure 

while describing the chemical substance 

as specifically as practicable, and for 

listing substances on the TSCA 

Chemical Substance Inventory. 

DATES: Submit comments on or before 

August 27, 2018. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2018–0292, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT:

For technical information contact: 

Tracy Williamson, Chemistry, 

Economics, and Sustainable Strategies 

Division (Mailcode 7406M), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; telephone number: (202) 

564–8569; email address: 

tscainventory@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 


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