[Federal Register Volume 82, Number 87 (Monday, May 8, 2017)]
[Notices]
[Pages 21386-21389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09182]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0144; FRL-9961-30]


Assignment and Application of the ``Unique Identifier'' Under 
TSCA Section 14; Notice of Public Meeting and Opportunity To Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Recent amendments to the Toxic Substances Control Act (TSCA) 
require EPA to assign a ``unique identifier'' whenever it approves a 
Confidential Business Information (CBI) claim for the specific chemical 
identity of a chemical substance, to apply this unique identifier to 
other information or submissions concerning the same substance, and to 
ensure that any nonconfidential information received by the Agency 
identifies the chemical substance using the unique identifier while the 
specific chemical identity of the chemical substance is protected from 
disclosure. EPA is requesting comment on approaches for assigning and 
applying unique identifiers. In addition, EPA invites all interested 
parties to attend a public meeting to provide oral comment.

DATES: Meeting Date: The public meeting will be held from 1 p.m. to 4 
p.m. on May 24, 2017.
    Meeting Registration: You may register online (preferred) or in 
person at the meeting. To register online, for the meeting, go to: 
https://tsca-unique-identifier.eventbrite.com. Advance registration for 
the meeting must be completed no later than May 22, 2017. On-site 
registration will be permitted, but seating and speaking priority will 
be given to those who pre-register by the deadline.
    Comments: EPA will hear oral comments at the meeting, and will 
accept written comments and materials submitted to the docket on or 
before July 7, 2017.

ADDRESSES: Meeting: The meeting will be held at the Ronald Reagan 
Building and International Trade Center, in the Horizon Ballroom, 
located at 1300 Pennsylvania Avenue Northwest, Washington, DC 20004. 
The meeting will also be available by remote access for registered 
participants. Registered participants will receive information on how 
to connect to the meeting prior to its start.
    Comments: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2017-0144, 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.
    Meeting.

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].
    To request accommodation of a disability, please contact Jessica 
Barkas, preferably at least 10 days prior to the meeting, to give EPA 
as much time as possible to process your request.
    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. General Information

A. Does this action apply to me?

    You may be affected by this action if you have or expect to submit 
information to EPA under TSCA. Persons who would use unique identifiers 
assigned by the Agency to seek information may also be affected by this 
action. The following list of North American Industrial Classification 
System (NAICS) codes is not intended to be exhaustive, but rather 
provides a guide to help readers determine whether this document 
applies to them. Potentially affected entities may include:
     Manufacturers, importers, or processors of chemical 
substances (NAICS codes 325 and 324110), e.g., chemical manufacturing 
and petroleum refineries.

[[Page 21387]]

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information 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

A. TSCA Section 14 Requirement To Assign a ``Unique Identifier''

    TSCA, as amended June 22, 2016, by the Frank R. Lautenberg Chemical 
Safety for the 21st Century Act, includes a requirement in section 
14(g)(4) for EPA to, among other things, ``assign a unique identifier 
to each specific chemical identity for which the Administrator approves 
a request for protection from disclosure. . . .''. EPA is required to 
use the ``unique identifier assigned under this paragraph to protect 
the specific chemical identity in information that the Administrator 
has made public'' and to ``clearly link the specific chemical identity 
to the unique identifier in such information to the extent 
practicable.'' 15 U.S.C. 2613(g)(4).
    The full requirements of TSCA section 14(g)(4) are as follows:
    EPA must:
    1. Develop a system to assign a unique identifier to each specific 
chemical identity for which the Administrator approves a request for 
protection from disclosure, which shall not be either the specific 
chemical identity or a structurally descriptive generic term. Sec.  
14(g)(4)(A)(i).
    2. Apply that identifier consistently to all information relevant 
to the applicable chemical substance. Sec.  14(g)(4)(A)(ii).
    3. 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. Sec.  14(g)(4)(B).
    4. Ensure that any nonconfidential information received by the 
Administrator with respect to a chemical substance included on that 
list while the specific chemical identity of the chemical substance is 
protected from disclosure under TSCA section 14 identifies the chemical 
substance using the unique identifier. Sec.  14(g)(4)(C).
    5. For each claim for protection of a specific chemical identity 
that has been denied by the Administrator or expired, or that has been 
withdrawn by the person who asserted the claim, and for which the 
Administrator has used a unique identifier assigned under Sec.  
14(g)(4) to protect the specific chemical identity in information that 
the Administrator has made public, clearly link the specific chemical 
identity to the unique identifier in such information to the extent 
practicable. Sec.  14(g)(4)(D).

B. Assigning the Unique Identifier

    The identifier cannot be the specific chemical identity, or a 
structurally descriptive generic term. TSCA section 14(a)(4)(A)(i). 
Consequently, EPA must develop a system to assign such identifiers for 
each substance for which it makes a final determination approving a CBI 
claim for specific chemical identity. EPA is considering using a 
numeric identifier, which will incorporate the year the claim was 
approved. Including this date will facilitate tracking of the 
expiration of the CBI claims for specific chemical identity made in 
that document, pursuant to TSCA section 14(f)(3). EPA considered using 
a pre-existing identifier, specifically accession numbers, but language 
in TSCA section 8(b)(7)(B) suggests that accession numbers were 
intended to be distinct from the unique identifier (15 U.S.C. 
2607(b)(7)(B)), and expanding the use of accession numbers beyond their 
current use and purpose could be confusing (accession numbers are 
currently assigned following a notice of commencement of commercial 
manufacture or import under section 5, and identify chemicals that are 
or were formerly on the confidential portion of the TSCA Inventory, 
while the unique identifier is an outcome of a CBI determination under 
section 14--at this stage, very few chemicals with accession numbers 
have been subject to this new CBI review requirement, so the fact that 
a substance is identified using an accession number would not indicate 
anything reliable about whether chemical identity claims concerning the 
substance had been reviewed (let alone when they might expire)).

C. Application of the Unique Identifier

    Once the unique identifier is assigned, section 14(g)(4)(A)(ii) 
requires that EPA apply it to ``all information relevant to the 
applicable chemical substance.'' Section 14(g)(4)(C) instructs that any 
nonconfidential information received with respect to the chemical 
substance ``while the specific chemical identity of the chemical 
substance is protected from disclosure,'' identify the chemical 
substance using the unique identifier. In addition, section 14(g)(4)(D) 
requires that after the underlying CBI claim for specific chemical 
identity expires, is denied by EPA, or is withdrawn, specific chemical 
identity be ``clearly link[ed]'' to the unique identifier in public 
documents that previously used the unique identifier to ``protect the 
specific chemical identity in information that the Administrator has 
made public.''
    The two general requirements, (1) applying the unique identifier to 
other, non-confidential information concerning that substance (section 
14(g)(4)(A)(ii) and (C)); and (2) ``while the specific chemical 
identity is protected from disclosure,'' using the unique identifier in 
a manner that would ``protect the specific chemical identity in 
information that the Administrator has made public,'' (section 
14(g)(4)(C) and (D)), do not appear to be completely reconciled in the 
statute. EPA has identified several situations where applying the same 
unique identifier to every instance where information pertaining to the 
same chemical substance is reported under TSCA could cause CBI, 
including specific chemical identity, to be revealed.
    The intent of Congress with respect to the protection of 
confidential chemical identities is explicit in the legislative 
history: ``The Committee expects that redactions or the use of approved 
generic names or unique identifiers will be employed to meaningfully 
inform the public without comprising [sic] trade secrets.'' H.R. Rep. 
No.114-176, at 30 (2015). Yet the specific instructions in section 
14(g)(4) regarding assigning, applying, publishing and using the unique 
identifier would in some cases seem to disclose the very CBI that 
Congress has directed EPA to protect. Following is a more detailed 
discussion of the statutory provision. EPA desires comment on how to 
reconcile the different objectives of the provision.
    TSCA section 14(g)(4)(A)(ii) states that EPA shall apply the unique 
identifier ``consistently to all

[[Page 21388]]

information relevant to the applicable chemical substance.'' Section 
14(g)(4)(C) states that EPA shall ``ensure that any nonconfidential 
information . . . with respect to a chemical substance'' for which a 
unique identifier has been assigned ``identifies the chemical substance 
using the unique identifier.'' Reading these words in isolation 
suggests that a particular chemical substance would have a single 
unique identifier, assigned the first time EPA makes a final 
determination concerning a CBI claim to protect the specific chemical 
identity of that substance, and applied to public versions of other 
filings pertaining to that substance. Section 14(g)(4)(A)(ii) and (C). 
Further, if the CBI claim is later denied, expires, or is withdrawn, 
EPA is required (to the extent practicable) to clearly link the 
specific chemical identity to the unique identifier in any information 
that it has made public that used the unique identifier to protect the 
specific chemical identity. Sec.  14(g)(4)(D). The purpose of the 
unique identifier is to provide a specific reference identifier that 
protects the confidentiality claim to the specific chemical identity 
for the duration of the claim, while providing a way for the public to 
identify other filings pertaining to that substance.
    However, having a single unique identifier that is publicly applied 
to every submission containing that chemical identity and used for 
every instance in which there is nonconfidential information concerning 
that chemical substance may cause CBI to be revealed to one or more 
other parties (or the public at large), in some circumstances the 
specific chemical identity that EPA has determined is entitled to 
confidential treatment, and which was intended to be protected as noted 
in section 14(g)(4)(C) and (D).
    If documents concerning the same substance, submitted by different 
companies, at different times, and for different purposes, were to 
always be assigned the same unique identifier, then each company could 
learn that the substance was marketed in the United States by another 
company, and possibly learn of new uses and other information 
concerning the substance. Thus, one of the rationales for a CBI claim 
for specific chemical identity, i.e., that the chemical substance is 
manufactured for commercial purposes in the United States, might be 
disclosed to competitors, undermining the protection of that specific 
chemical identity that is part of the purpose for section 14(g)(4).
    Example 1: Company A files a Premanufacture Notice (PMN) and later 
commences import of Chemical X, for which its CBI claim for chemical 
identity is approved by EPA, resulting in Chemical X being placed on 
the confidential portion of the TSCA Inventory. Company B subsequently 
files a notice of substantial risk under TSCA section 8(e) on the same 
substance, which it is utilizing for research and development, also 
claiming chemical identity as CBI. EPA approves this claim and assigns 
the same unique identifier.
    By connecting submissions from different companies with the unique 
identifier, Company B can determine the confidential information that 
Chemical X is in US commerce (without having to submit and meet the 
terms of a bona fide request under 40 CFR 720.25). Both companies can 
now determine that another company has an active interest in the same 
chemical. Both companies also can determine any non-CBI information 
about the other company, uses, or other information that might be in 
the other submission.
    Further, if the specific chemical identity is not uniformly claimed 
as CBI in all such submissions, applying the unique identifier to a 
submission with a non-confidential chemical identity effectively 
destroys the CBI claim for chemical identity in all other documents 
that use the same unique identifier. E.g., in Example 1, if Company B 
chose to not claim chemical identity as CBI in its section 8(e) filing 
regarding an R & D use, and EPA applied the unique identifier to the 
section 8(e) submission, this submission could be readily linked to 
Company A's submission, and the confidential chemical identity in 
Company A's submission would be revealed to the public, along with the 
fact that Chemical X is in commerce in the United States.
    There are additional circumstances where the action or inaction of 
one company could cause the CBI of another company to be revealed:
    Example 2: EPA receives and approves Company A's CBI claim for 
chemical identity in a Notice of Commencement (NOC). The substance is 
placed on the confidential portion of the Inventory and a unique 
identifier is assigned. Subsequently, Company B files a bona fide 
notice concerning the same substance. Company B does not claim chemical 
identity as CBI. In accordance with section 14(g)(4)(C), EPA applies 
the unique identifier to the public version of the bona fide 
submission.
    Applying the unique identifier to the bona fide submission 
effectively discloses the identity of Company A's chemical, and reveals 
that the substance is in US commerce. Because it is now not a secret 
that the substance is in US commerce, the substance would be removed 
from the confidential portion of the Inventory, and all information 
concerning uses, company identity, and other information that was not 
claimed as CBI in the underlying PMN, NOC, and the bona fide notice 
could be linked together, potentially further disclosing information 
about the chemical that the other company may have claimed as 
confidential.

Alternative Approaches

    Following are two alternative approaches to applying the unique 
identifier to other submissions for the same chemical substance to 
meaningfully inform the public without compromising trade secrets. 
These approaches are intended to give the greatest possible effect to 
the language of section 14(g)(4) concerning the application of the 
unique identifier to related submissions, while (also in accordance 
with section 14(g)(4)) maintaining the EPA-approved confidentiality of 
certain chemical identities. EPA invites comments on applying the 
unique identifier to all submissions containing a particular chemical 
substance and on these alternative approaches, as well as suggestions 
for other possible approaches.

First Alternative

    There are readings of section 14(g)(4) that may avoid or ameliorate 
what are otherwise contradictory instructions. For example, section 
14(g)(4)(C) may plausibly be read as instructing EPA to ensure that any 
non-confidential information received by EPA concerning a confidential 
chemical substance should identify the substance using only the unique 
identifier, so long as the confidential identity remains protected from 
disclosure. In this way, the public (including other companies) could 
identify the various submissions concerning a particular chemical, but 
could not identify the specific chemical.
    However, the fact that information not claimed as confidential 
would need to be treated as such might be viewed as inconsistent with 
policy (as reflected in the FOIA and in TSCA amendments) to limit CBI 
protection to relatively narrow set of circumstances. This option also 
presents a number of implementation challenges. For example, this 
approach would require EPA to carefully screen incoming, non-CBI 
submissions against its list of confidential chemical names, and to 
treat as CBI information to which no such claim was made, a process 
that carries considerable risk of error.

[[Page 21389]]

Further, the facts of a specific case may affect whether the original, 
unaltered and non-CBI submissions could be prevented from release 
pursuant to a Freedom of Information Act (FOIA) request. Finally, 
screening and redacting submissions in this way may be such a burden on 
EPA resources as to be impracticable.

Second Alternative

    Under this approach, unique identifiers, once assigned, are applied 
to other submissions concerning that chemical substance, but only those 
that are submitted by the same person/company. Additional submissions 
concerning the same substance that are submitted by a different company 
would be assigned a different unique identifier. The unique identifier 
would not be applied to or associated with non-confidential information 
if the effect of that application would be to reveal the identity of an 
approved confidential chemical that is otherwise protected from 
disclosure under section 14. The public would be able to link some 
submissions on the same chemical, but not necessarily all submissions 
on that chemical.
    The public could use generic identities and the identities provided 
in non-confidential filings to group together submissions on similar 
chemicals, but would not be able to tell, with certainty, whether 
filings bearing different unique identifiers pertain to the same 
chemical or two different chemicals with generically similar 
structures. This option at least partly fulfills the intent to link 
information concerning the same substance, while maintaining the 
approved confidentiality claims of each submitter, until such claims 
are withdrawn, expire, or are subsequently denied by EPA. At that time, 
EPA would then append or otherwise make known to the public the 
specific identity that corresponds to the unique identifier used in 
such filings, in accordance with section 14(g)(4)(D).
    EPA notes that this alternative is consistent with EPA's history of 
reconciling ambiguities and apparent contradictions concerning TSCA 
confidentiality. Since the inception of TSCA, the Agency has needed to 
balance the requirements and interests in protecting confidentiality 
with the requirements and interests in public disclosure of chemical 
information. For example, in the preamble to the final rule 
establishing the initial TSCA Inventory, EPA discussed an apparent 
conflict between TSCA sections 8(b) and 5(a)'s requirements to include 
certain chemical identities on the Inventory (to publish a list of 
``each chemical substance which is manufactured in the United States,'' 
including ``each chemical substance which any person reports under 
section 5''), and section 14's requirement that information exempt from 
disclosure under FOIA exemption 4 (5 U.S.C. 552(b)(4)) not be disclosed 
except in accordance with section 14(a) and (b). 42 FR 64573 (December 
23, 1977). EPA ultimately resolved this apparent conflict by attempting 
to balance the competing concerns (informing the public and defining 
what is a new chemical under TSCA, versus protecting CBI and trade 
secrets) by creating a confidential portion of the Inventory, and 
setting up the bona fide inquiry process to permit limited disclosure 
of CBI to individual companies seeking to determine whether they are 
required to file a PMN.
    Another example can be found in the preamble to the final rule 
implementing section 12(b) of TSCA, the export notification 
requirements. 45 FR 82847 (December 16, 1980). Section 12(b) requires 
EPA to report certain specific chemical identities to certain foreign 
governments under specified circumstances. Section 14(b) prohibits 
disclosure of information claimed as CBI except under specified 
circumstances, such that it appeared that EPA could not report the 
information required under section 12(b) without violating section 14. 
Reasoning that because the statute must be interpreted to give the 
fullest possible effect to both sections, EPA concluded that section 
12(b) requires the notification to foreign governments, even if the 
chemical identity is confidential, but prohibits disclosure of such 
confidential information to other persons. Otherwise, the notification 
required by section 12(b) would be meaningless and not carry out the 
purpose of the section.

D. Opportunity To Comment on Approach To Applying the Unique Identifier

    In addition to general comments on the possible approaches outlined 
above, EPA invites comment on other suggested approaches.

III. Meeting

A. Remote Access

    The meeting will be accessible remotely for registered 
participants. Registered participants will receive information on how 
to connect remotely to the meeting prior to its start.

B. Public Participation at the Meeting

    Anyone may register to attend the meeting as observers and may also 
register to provide oral comments on the day of the meeting. A 
registered speaker is encouraged to focus on issues directly relevant 
to the meeting's subject matter. Based on level of interest in 
speaking, each speaker may be limited to five minutes to provide oral 
comments. To accommodate as many registered speakers as possible, 
speakers may present oral comments only, without visual aids or written 
material.

C. Submitting Written Materials

    Anyone may submit written materials to the docket as described 
under ADDRESSES.

IV. How can I request to participate in the meeting?

A. Registration

    To attend the meeting in person or to receive remote access, you 
must register no later than May 22, 2017, using the method described 
under DATES. While on-site registration will be available, seating will 
be on a first-come, first-served basis, with priority given to early 
registrants, until room capacity is reached. The Agency anticipates 
that approximately 150 people will be able to attend the meeting in 
person. For registrants not able to attend in person, the meeting will 
also provide remote access capabilities; registered participants will 
be provided information on how to connect to the meeting prior to its 
start.

B. Required Registration Information

    Members of the public may register to attend as observers or speak 
if planning to offer oral comments during the scheduled public comment 
period. To register for the meeting online, you must provide your full 
name, organization or affiliation, and contact information to the on-
line signup. Do not submit any information in your request that is 
considered CBI. Requests to participate in the meeting, identified by 
docket ID No. EPA-HQ-OPPT-2017-0144, must be received on or before May 
22, 2017.

    Authority:  15 U.S.C. 2613.

    Dated: April 21, 2017.
Louise P. Wise,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2017-09182 Filed 5-5-17; 8:45 am]
 BILLING CODE 6560-50-P