[Federal Register Volume 83, Number 27 (Thursday, February 8, 2018)]
[Notices]
[Pages 5623-5625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02548]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0144; FRL-9972-94]


Assignment and Application of the ``Unique Identifier'' Under 
TSCA Section 14; Notice of Additional Information 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 develop a system 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 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 previously requested 
comment on approaches for assigning and applying unique identifiers, 
and has developed an additional approach on which it now requests 
comment.

DATES: EPA will accept written comments and materials submitted to the 
docket on or before March 12, 2018.

ADDRESSES: 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.

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. General Information

A. Does this action apply to me?

    You may be affected by this action if you have submitted 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.

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''

    The June 22, 2016, amendments to TSCA by the Frank R. Lautenberg 
Chemical Safety for the 21st Century Act added a requirement in TSCA 
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 ``apply that identifier 
consistently to all information relevant to the applicable chemical 
substance,'' including ``any nonconfidential information received by 
the Administrator with respect to a

[[Page 5624]]

chemical substance . . . while the specific chemical identity of the 
chemical substance is protected from disclosure.'' 15 U.S.C. 
2613(g)(4).
    The requirements to assign a unique identifier and the unreconciled 
requirements concerning application of the unique identifier and 
protection of CBI are more fully discussed in the Federal Register 
document published previously. (See 82 FR 21386; May 8, 2017; hereafter 
``May 8 Federal Register document''.) EPA has noted drawbacks to each 
of the two alternative approaches discussed in the May 8 Federal 
Register document.
    EPA has developed a third alternative approach for reconciling the 
competing requirements of TSCA section 14(g), and now invites public 
comment on this new alternative.
    A brief explanation of CBI claims for chemical identity provides 
context for understanding the potential effects of applying a unique 
identifier. TSCA section 14 permits a person to assert a CBI claim to 
seek to protect from public disclosure certain information in a 
submission, including a specific chemical identity. A CBI claim for 
specific chemical identity is intended to protect from disclosure the 
existence of the chemical substance and/or the fact that the chemical 
substance is (or is intended to be) manufactured by any person for 
commercial purposes in the United States (note that under TSCA, the 
term ``manufacture'' includes import).
    When a chemical identity on the TSCA Inventory (Inventory) is 
claimed as CBI, then the chemical substance is maintained on the 
confidential portion of the Inventory. Conversely, a specific chemical 
identity that appears on the public portion of the Inventory, and is 
therefore known to be (or to have been) manufactured for commercial 
purposes in the United States, is generally not eligible for 
confidential protection (see, e.g., Chemical Data Reporting regulations 
at 40 CFR 711.30(b)). If another company reveals that they manufacture 
the substance for commercial purposes, such as in a non-CBI submission 
filed under TSCA, the chemical identity is no longer eligible for 
confidential protection, and a CBI claim for chemical identity would be 
denied upon evaluation. Because the meaning of a CBI claim for chemical 
identity is limited, companies that wish to protect other information 
in a submission (such as company identity or specific information 
regarding the use, function, or application of that chemical substance) 
should claim that specific information as CBI rather than (or in 
addition to) chemical identity.

B. Third Alternative Approach

    Under this approach, EPA would assign one unique identifier (UID) 
per chemical substance. In most cases EPA would apply the UID to all 
non-confidential information concerning the same chemical substance, 
from any company. However, in a small number of cases, EPA would not 
apply the UID to some non-confidential documents, in order to preserve 
approved CBI claims for specific chemical identity where the non-
confidential document itself does not undermine the CBI claim, but 
EPA's application of the UID to that document would result in a linkage 
that does undermine the CBI claim. The basic criterion for application 
of the UID to submissions made by different submitters is that the 
Agency's act of applying the UID must not disclose to the public the 
confidential specific chemical identity that the UID was assigned to 
protect.
    Specifically, prior to applying a UID to public versions of 
documents concerning the same substance, and filed by different 
submitters, those documents would be reviewed for presence of the 
specific chemical identity. If the specific chemical identity (e.g., 
Chemical Abstracts Service (CAS) name or CAS number) appears in any of 
the documents, EPA would revisit the CBI claim in the remaining 
document(s) to assure that the claim is unexpired and otherwise still 
valid. If the CBI claim remains valid, EPA would not apply the UID to 
the document that reveals the specific chemical identity, in order to 
preserve the CBI claim in the other document(s) (if the claim has 
expired, been withdrawn, or appears no longer valid, EPA would act in 
accordance with section 14(f)(2)(B) and/or 14(g)(4)(D), as 
appropriate). All of the documents would be available to the public, 
and the specific chemical identity would be revealed in the document 
where it was not claimed as CBI--the document revealing the specific 
chemical identity would simply not be connected by the UID to the other 
document(s) where the specific chemical identity is CBI.
    For example, Company A files a Premanufacture Notice (PMN) and 
later, a Notice of Commencement (NOC), claiming chemical identity as 
CBI to protect from disclosure the fact that the chemical is now being 
manufactured for commercial purposes in the United States and hence is 
being added to the Inventory. EPA approves the CBI claim and assigns a 
UID. Company A subsequently files a section 8(e) notice concerning the 
same substance, claiming chemical identity as CBI again. The UID is 
applied to that submission as well. Sometime later, Company B files a 
section 8(e) notice on the same substance, which it asserts it is using 
for research and development (R&D) purposes, but does not claim 
chemical identity as CBI. EPA revisits Company A's original CBI claim 
and confirms that it is not expired, has not been withdrawn, and has 
not been denied. Company B's submission does not reveal that the 
substance is on the Inventory or that it is in commerce (as other than 
an R&D substance). If EPA applied the UID to Company B's submission, 
that act would link Company B's section 8(e) notice to Company A's NOC, 
revealing that the specific chemical identity in Company B's section 
8(e) notice is also the subject of an NOC and has therefore been 
manufactured for commercial purposes, and is on the Inventory. Thus, 
EPA's linkage of the two documents through the applied UID--as opposed 
to any information contained in the non-confidential document itself--
would undermine the previously approved CBI claim for chemical 
identity. EPA would not apply the UID to Company B's submission in this 
case, to preserve Company A's CBI claim.
    By way of contrast, if Company B's non-confidential section 8(e) 
notice itself revealed that the chemical substance was manufactured for 
commercial purposes in the United States--for instance, if the filing 
were an incident report relating to the commercial manufacture or use 
of that chemical substance, as opposed to an R&D exploration as 
originally described--then this would indicate that Company A's CBI 
claim may no longer be valid, and EPA would reevaluate the prior CBI 
claim in accordance with TSCA section 14(f)(2)(B) and/or 14(g)(4)(D), 
as appropriate.
    EPA expects that exceptions to application of the UID will be 
fairly rare. For example, in reviewing all non-confidential section 
8(e) submissions submitted over the past 5 years that included a CAS 
number (such that Inventory status can be readily checked), EPA found 
that fewer than 4% of these submissions mentioned substances that are 
currently on the confidential portion of the TSCA Inventory. Further, 
on preliminary review (i.e., without completing a full CBI review and 
determination), it appeared that several of these submissions were 
under circumstances indicating that the original CBI claim may have 
been withdrawn or otherwise became invalid, suggesting that there may 
be even fewer exceptional cases

[[Page 5625]]

once EPA revisits the original CBI claim(s).
    EPA acknowledges that this approach would occasionally create the 
possibility that the application of the UID to submissions from two or 
more companies may alert each company to the other's manufacture of the 
same chemical substance. However, such disclosures frequently arise in 
the normal course of business under TSCA, independent of UID. One 
reason for this is that a single accession number is typically assigned 
to each Inventory substance, and the accession number is often used for 
subsequent reporting, e.g., under the Chemical Data Reporting (CDR) 
rule. Accession numbers are also included alongside other regulatory 
information, such as relevant section 5 significant new use rule (SNUR) 
citations, reported in public databases, such as the Substance Registry 
Service (SRS), and in the Inventory file that EPA makes available to 
the public (confidential inventory chemicals are listed by PMN number, 
accession number, and generic name). (See https://www.epa.gov/tsca-inventory/how-access-tsca-inventory.) Anyone that has an accession 
number for a given confidential inventory substance can query the CDR 
database and learn whether other companies have manufactured the 
chemical in CDR-reportable amounts, or query the public Inventory to 
find out the PMN number of the original submission.
    While not every company reports under the CDR for every chemical 
that they manufacture (for example, specialty chemical companies may be 
making relatively small quantities of a substance, for a specialized 
use, and may not meet the reporting thresholds for CDR), the fact that 
a chemical substance is on the Inventory can be revealed in other ways. 
For example, a company that intends to manufacture a chemical substance 
for commercial purposes may file a bona fide submission under 40 CFR 
720.25 to determine whether the chemical substance is already on the 
Inventory. The response to the bona fide inquiry, where EPA tells the 
submitter whether a chemical substance is on the confidential portion 
of the Inventory, would indicate whether another company has 
manufactured the chemical substance for commercial purposes in the 
United States. Also, submitters of section 5 notices that are 
subsequently deemed to be invalid because the substance is already on 
the Inventory and thus not subject to section 5 reporting requirements 
are informed of the Inventory status and are provided the accession 
number.
    This third alternative approach would avoid several problems that 
EPA has identified with assigning more than one UID to a single 
substance (see ``Second Alternative Approach,'' May 8 Federal Register 
document (at 21389). One such problem is that assigning more than one 
UID per chemical substance would work against one of the purposes of 
assigning UIDs, 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.'' (See discussion 
in EPA's May 8 Federal Register document (at 21388).) In addition, it 
is unclear how multiple UIDs per chemical can be reconciled with the 
section 8(b)(7) requirement to publish and keep current a list of each 
confidential Inventory chemical, with its UID, accession number, 
generic name, and PMN number, where applicable. Any list that includes 
all of this information for each chemical would automatically link 
submissions from different companies by including all of the UIDs and/
or by using the same accession number for multiple listings on the same 
chemical. (i.e., if Chemical X has three UIDs, assigned to three 
different company claims, they would all be linked on this list, 
because Chemical X only has one accession number, and the list is 
supposed to include both accession number and UID.) It is also unclear 
to EPA how using one UID per chemical, per company, would operate in 
the case that a company or parts of a company changes ownership; how 
such UIDs would be applied to EPA-generated documents that are relevant 
to more than one submission; or how the multiple UIDs would be handled 
in the case that one company withdraws or permits its CBI claim to 
expire while the other does not. Using one UID per chemical, and 
applying that same UID to related documents in all but a very few 
exceptional cases, would avoid these issues.

C. Opportunity To Comment on Approach to Applying the Unique Identifier

    EPA invites comment on the possible approach outlined above.

    Authority: 15 U.S.C. 2613.

    Dated: January 26, 2018.
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical 
Safety and Pollution Prevention.
[FR Doc. 2018-02548 Filed 2-7-18; 8:45 am]
 BILLING CODE 6560-50-P


