83 FR 30168 - TSCA Chemical Substances; Unique Identifier Assignment and Application Policy; Notice of Availability

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 124 (June 27, 2018)

As amended in 2016, the Toxic Substances Control Act (TSCA) requires EPA to develop a system to assign a unique identifier (UID) whenever it approves a confidential business information (CBI) claim for the specific chemical identity of a chemical substance, to apply this UID to other information concerning the same chemical substance, and to ensure that any non-confidential information received by the Agency identifies the chemical substance using the UID while the specific chemical identity of the chemical substance is protected from disclosure. EPA previously requested comment on several approaches for assigning and applying UIDs. EPA has determined that it will use a numerical identifier that incorporates the year the CBI claim was asserted, and will apply this UID to non-confidential information related to the chemical substance, except where the Agency's act of applying the UID would itself disclose to the public the confidential specific chemical identity that the UID was assigned to protect.

[Federal Register Volume 83, Number 124 (Wednesday, June 27, 2018)]
[Notices]
[Pages 30168-30171]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13829]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0144; FRL-9979-59]


TSCA Chemical Substances; Unique Identifier Assignment and 
Application Policy; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: As amended in 2016, the Toxic Substances Control Act (TSCA) 
requires EPA to develop a system to assign a unique identifier (UID) 
whenever it approves a confidential business information (CBI) claim 
for the specific chemical identity of a chemical substance, to apply 
this UID to other information concerning the same chemical substance, 
and to ensure that any non-confidential information received by the 
Agency identifies the chemical substance using the UID while the 
specific chemical identity of the chemical substance is protected from 
disclosure. EPA previously requested comment on several approaches for 
assigning and applying UIDs. EPA has determined that it will use a 
numerical identifier that incorporates the year the CBI claim was 
asserted, and will apply this UID to non-confidential information 
related to the chemical substance, except where the Agency's act of 
applying the UID would itself disclose to the public the confidential 
specific chemical identity that the UID was assigned to protect.

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 UIDs 
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. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification 
(ID) number EPA-HQ-OPPT-2017-0144, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics 
Docket (OPPT Docket), Environmental Protection Agency Docket Center 
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW, Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

II. Background

A. What is the authority for this action?

    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 non-confidential information received by 
the Administrator with respect to a chemical substance . . . while the 
specific chemical identity of the chemical substance is protected from 
disclosure.'' 15 U.S.C. 2613(g)(4).

B. EPA Sought Public Comment

    The requirements to assign a UID and the unreconciled requirements 
concerning application of the UID and protection of CBI are more fully 
discussed in a document that published in the Federal Register on May 
8, 2017. (See 82 FR 21386; May 8, 2017; hereafter ``May 2017 Federal 
Register document''.) EPA noted drawbacks to each of the two 
alternative approaches discussed in the May 2017 Federal Register 
document, and subsequently developed a third alternative approach for 
reconciling the competing requirements of TSCA section 14(g), on which 
it requested comment in the Federal Register on February 8, 2018. (See 
83 FR 5623; hereafter ``February 2018 Federal Register document'').

III. Policy

A. UIDs Will Be a Numerical Identifier

    The UID cannot be the specific chemical identity, or a structurally 
descriptive generic term. TSCA section 14(a)(4)(A)(i). Consequently, 
EPA has developed a system to assign UIDs for each substance for which 
it makes a final determination approving a CBI claim for specific 
chemical identity. The UID is a number that incorporates the year that 
the claim was asserted (e.g., the first approved claim asserted in 2019 
would be UID-2019-00001). 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(e). The reasons for not 
using a preexisting identifier, such as the accession number, are 
further explained in the May 2017 Federal Register document. Note that 
in the May 2017 Federal Register document, it was suggested that the 
UID year would be based on year the claim was approved. See 82 FR at 
21387. However, because the year of approval may be different from the 
year the claim was asserted (e.g., claims made in December may not be 
approved until the following February), and because the initial 
expiration date of the claim runs from the point that the claim was 
asserted, EPA determined that the date would better facilitate claim 
expiration tracking if it were based on the year the claim was 
asserted.

B. EPA Will Apply UIDs to Related Documents, Except Where It Discloses 
Confidential Chemical Identity

    EPA is adopting the ``third alternative approach,'' as described in 
the February

[[Page 30169]]

2018 Federal Register document. Under this approach, EPA will assign 
one UID per chemical substance. In most cases, EPA will apply the UID 
to all non-confidential information relevant to the applicable chemical 
substance, from any company. However, in a small number of cases, EPA 
will not apply the UID to some non-confidential documents, in order to 
preserve approved, still-valid CBI claims for specific chemical 
identity. These would be cases in which 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 would undermine the 
CBI claim and reveal the CBI. The 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.
    EPA believes that this is the best of the approaches considered 
because it most appropriately balances the two purposes of the UID 
provisions: to provide public linkages between related non-confidential 
information concerning a particular confidential chemical substance 
(i.e., to promote transparency), and to protect information that EPA 
has determined to be entitled to confidential treatment. It does so by 
providing linkages to the maximum extent possible while still 
preserving valid claims of CBI for chemical identity. The third 
alternative approach also has the advantage of being more 
straightforward to administer than the other two alternative approaches 
considered. Most public commenters supported this approach over the 
other alternatives for similar reasons.
    By contrast, the other two alternative approaches (described more 
fully in the May 2017 Federal Register document) would not provide this 
balance, and would have other significant disadvantages. The ``first 
alternative approach'' would have construed section 14(g)(4)(C) 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 UID, for so long as the 
confidential identity remained protected from disclosure. This approach 
would have involved carefully searching for and removing specific 
chemical identifying information from all documents relating to the 
applicable chemical, even where that information was not claimed as 
CBI, in order to replace that specific information with the UID. This 
approach would have provided a linkage between documents concerning the 
same chemical, while at least superficially maintaining the 
confidentiality of the CBI claim for chemical identity, but would 
require withholding or withdrawing information that would otherwise be 
(or was previously) public. Moreover, because many related documents 
may already have long been made public, removing chemical identities 
from these documents would have been ineffectual in some cases (such as 
when the older, complete version of a document can be compared with the 
newer version with specific chemical identity redacted).
    In the ``second alternative approach,'' whereby a UID would be 
assigned to each chemical-company combination (different companies 
submitting information on the same substance would be assigned 
different UIDs for that substance), the CBI protection goal would at 
least initially be met, but only at considerable expense to the other 
goal of the UID provisions--to provide the public with links between 
related documents. In addition, this approach would have raised its own 
administrative issues, such as what to do with the UID 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 a substance 
that is referenced in multiple submissions from different companies; 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. 
Finally, this approach seems unreconciled with the TSCA section 8(b)(7) 
requirement to publish UIDs alongside other identifiers for the same 
chemical--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. (For example, 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.)

IV. Public Comments

A. Summary of Public Comments

    In response to the two requests for comment, in the May 2017 and 
February 2018 Federal Register documents, EPA received a total of 20 
comments from 14 identified commenters (some commenters responded to 
both requests).
    In response to the first request for comment (May 2017 Federal 
Register document), most commenters, including seven of eight industry 
or trade group commenters, and one non-governmental organization (NGO) 
commenter, preferred the one UID per company-chemical combination 
approach (``second alternative approach''). No commenter supported the 
``first alternative approach.'' One NGO commenter argued that assigning 
more than one UID to any given chemical was contrary to the purpose and 
requirements of the UID provisions. One trade association argued for an 
even more complex system of UIDs (the ``parent-daughter identifier 
approach''), whereby even submissions from the same company may be 
assigned different UIDs, and would involve assigning additional UIDs 
for EPA-generated documents and other third-party submissions--none of 
which would be linkable by the public.
    In response to the second request for comment (February 2018 
Federal Register document), most commenters expressed support for the 
``third alternative approach''--applying the UID to all related 
information, but with some exceptions to preserve approved and still-
valid CBI claims for chemical identity, as explained above. Commenters 
supporting the third alternative approach included three trade groups 
that had previously supported the one UID per company-chemical 
combination approach, and two more trade groups that had not previously 
commented. One NGO commenter maintained the position that they had 
taken in their earlier comment, in response to the first request for 
comment, that EPA should apply the UID to all related documents, 
regardless of the effect on approved CBI claims for chemical identity. 
This same commenter indicated, however, that the third alternative 
approach was an improvement over, and would be preferred to, the other 
two alternatives. One trade group maintained its preference for a 
``parent-daughter identifier'' approach. Two commenters did not express 
a preference or position with respect to approach, but requested 
clarification regarding EPA's CBI review procedures or commented in 
general support of balancing public transparency with CBI protections.

B. Response to Comments

    EPA has prepared a separate response to comments document, a copy 
of which is available in the docket for this action (Ref. 1), and is 
also including the

[[Page 30170]]

following summary response to selected comments.
    1. ``Parent-daughter identifier'' approach. One commenter proposed 
that EPA adopt a system of document identifiers, such that documents 
concerning the same substance would use several different identifiers, 
the relationship between which only EPA would be aware. Documents 
concerning the same substance, submitted by different companies, and 
even documents submitted by the same company, would or could have 
different identifiers. The public would be able to link together only 
those documents that are submitted by the same person, and that have 
the same CBI status (CBI vs. non-CBI). The commenter explained that 
this system would provide more protection to CBI information than would 
be provided by using one chemical identity per company, as in the 
second alternative approach.
    This approach would be largely inconsistent with both the letter of 
TSCA section 14(g)(4) and the intent of setting up a UID system. EPA 
interprets TSCA section 14(g)(4)(A)(i) (requiring the Agency to 
``assign a unique identifier to each specific chemical identity'' 
(emphasis added)), to indicate that the UID was intended to be a single 
identifier for each chemical. Moreover, as noted in the February 2018 
Federal Register document, the reason for assigning multiple UIDs per 
chemical (CBI protection) is not possible to reconcile with the TSCA 
section 8(b)(7) requirement that for each confidential chemical 
substance, EPA ``shall make available to the public . . . the unique 
identifier assigned under [section 14], accession number, generic name, 
and, if applicable, premanufacture notice case number.'' The 
publication of the UIDs alongside their corresponding accession number 
(for which there is generally only one per chemical) would cause all of 
the UIDs for a given substance to be linked together. The approach 
advocated in this comment would also largely defeat one of the two 
purposes of the UID provision--to provide a publicly-accessible link 
between information concerning the same substance.
    2. ``Straightforward'' approach. One commenter asserted that the 
text of section 14(g)(4) is plain about EPA's obligations to apply the 
UID uniformly, regardless of consequence for approved CBI claims, and 
thus advocated for a reading of the statute where one UID is assigned 
to each chemical, and making no exceptions in applying UIDs to related 
information (i.e., the ``straightforward'' approach). EPA disagrees 
that Congress plainly intended that approved, valid CBI claims should 
be disregarded as UIDs are applied to related documents. As is noted in 
the May 2017 Federal Register document, EPA understands the UID as 
having two purposes: providing a public linkage between information on 
the same chemical substance, and protecting approved CBI claims for 
specific chemical identity. Under the ``straightforward'' approach, 
those two purposes would conflict with each other in certain 
circumstances, while the third alternative approach selected by EPA 
balances the two purposes without this conflict.
    The UID is specifically described in the statute as an identifier 
assigned ``to protect the specific chemical identity'' of the subject 
chemical. Section 14(g)(4)(D). It would plainly undermine that 
Congressional purpose if application of the UID itself were the means 
by which an otherwise valid chemical identity CBI claim was disclosed. 
Congress' intention that the UID preserve valid CBI claims is further 
evidenced by the requirement that the UID ``shall not be . . . the 
specific chemical identity.'' Section 14(g)(4)(A)(i). Similarly, 
section 14(g)(4)(B) requires EPA to publish an annual list of 
confidential chemical substances ``referred to by their unique 
identifiers . . . including the expiration date for each such claim.'' 
This further reflects Congress' understanding that the duration of a 
valid CBI claim would be determined by its expiration date and that the 
UID would serve to link documents pertaining to a confidential chemical 
during that period, not to terminate the period. Section 14(g)(4)(C) in 
turn instructs EPA to ensure that any non-confidential information 
received by EPA regarding a chemical substance ``on the list published 
under paragraph (B)'' while the specific identity is protected from 
disclosure identifies the chemical using the UID. It is apparent that 
Congress intended the UID to serve the function of enabling the public 
to link such non-confidential information to other documents pertaining 
to the same confidential chemical during the life of the valid CBI 
claim as reflected on the list under paragraph (B), not to terminate 
the period of protection. Finally, section 14(g)(4)(D) requires EPA to 
link the specific identity of a chemical substance to the corresponding 
UID in three circumstances: where the claim has been denied, has 
expired, or has been withdrawn. If Congress had intended for the 
application of the UID itself to reveal the confidential chemical 
identity, it presumably would have included this circumstance in the 
list in section 14(g)(4)(D).
    The approach suggested by the commenter might also tend to increase 
CBI claims for chemical identity. Many TSCA section 8(e) filings, for 
example, concern chemicals that are in the research and development 
(R&D) stage. At this early stage, not all companies claim the chemical 
identity as CBI. Under the ``straightforward'' approach, any time a 
company chooses to not claim an R&D chemical identity as CBI, they 
would foreclose any chance (of theirs, or of a competitor's) to 
maintain a successful CBI claim for the specific identity of that 
substance in the future. This is because even if such a claim were made 
and approved in, for example, a section 5 Notice of Commencement, the 
confidential chemical identity, and the fact the substance is in 
commerce in the United States, would be revealed as soon as EPA applied 
the UID to the related R&D 8(e) submission and made the labeled 
submission public. In order to avoid this foreclosure of opportunity, 
TSCA section 8(e) submitters may feel compelled to claim more R&D 
chemical identities as CBI.
    EPA believes that section 14(g)(4) is best read as instructing EPA 
to provide a public linkage of non-confidential information that 
concerns each confidential chemical substance, while simultaneously 
protecting approved and valid CBI claims. It is both appropriate and 
lawful for EPA to interpret conflicting requirements of a provision in 
a manner that minimizes those conflicts, because provisions of a text 
should be interpreted in a way that renders them compatible and not 
contradictory. Accordingly, EPA is acting consistent with TSCA by 
attempting to balance two requirements that occasionally conflict with 
one another.
    3. UID application procedure. Several commenters urged EPA to 
develop procedures to assure that confidential chemical identities are 
not inappropriately disclosed as EPA applies UIDs to related non-
confidential documents. Some commenters also requested clarification on 
how exceptions to UID application will occur.
    EPA has developed procedures for applying UIDs to related 
documents, prior to releasing those labeled documents to the public. 
EPA will search its records and screen incoming submissions for non-
confidential information that relates to the applicable confidential 
chemical identity (using CASRN, accession number, PMN number, specific 
name,

[[Page 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