83_FR_5650 83 FR 5623 - Assignment and Application of the “Unique Identifier” Under TSCA Section 14; Notice of Additional Information and Opportunity To Comment

83 FR 5623 - Assignment and Application of the “Unique Identifier” Under TSCA Section 14; Notice of Additional Information and Opportunity To Comment

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 27 (February 8, 2018)

Page Range5623-5625
FR Document2018-02548

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.

Federal Register, Volume 83 Issue 27 (Thursday, February 8, 2018)
[Federal Register Volume 83, Number 27 (Thursday, February 8, 2018)]
[Notices]
[Pages 5623-5625]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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



                                                                           Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Notices                                             5623

                                               NYISO Electric System Planning                          approves a Confidential Business                      information to EPA under TSCA.
                                               Working Group Meeting                                   Information (CBI) claim for the specific              Persons who would use unique
                                                                                                       chemical identity of a chemical                       identifiers assigned by the Agency to
                                               February 22, 2018, 10:00 a.m.–4:00 p.m.
                                                                                                       substance, to apply this unique                       seek information may also be affected by
                                               (EST)
                                                                                                       identifier to other information                       this action. The following list of North
                                                 The above-referenced meeting will be                  concerning the same substance, and to                 American Industrial Classification
                                               via web conference and teleconference.                  ensure that any nonconfidential                       System (NAICS) codes is not intended
                                                 The above-referenced meeting is open                  information received by the Agency                    to be exhaustive, but rather provides a
                                               to stakeholders.                                        identifies the chemical substance using               guide to help readers determine whether
                                                 Further information may be found at:                  the unique identifier while the specific              this document applies to them.
                                               http://www.nyiso.com/public/                            chemical identity of the chemical                     Potentially affected entities may
                                               committees/documents.jsp?com=bic_                       substance is protected from disclosure.               include:
                                               espwg&directory=2018-02-22                              EPA previously requested comment on                     • Manufacturers, importers, or
                                                                                                       approaches for assigning and applying                 processors of chemical substances
                                               NYISO Management Committee
                                                                                                       unique identifiers, and has developed                 (NAICS codes 325 and 324110), e.g.,
                                               Meeting
                                                                                                       an additional approach on which it now                chemical manufacturing and petroleum
                                               February 28, 2018, 10:00 a.m.–2:00 p.m.                 requests comment.                                     refineries.
                                               (EST)                                                   DATES: EPA will accept written
                                                                                                                                                             B. What should I consider as I prepare
                                                  The above-referenced meeting will be                 comments and materials submitted to
                                                                                                                                                             my comments for EPA?
                                               via web conference and teleconference.                  the docket on or before March 12, 2018.
                                                  The above-referenced meeting is open                 ADDRESSES: Submit your comments,                         1. Submitting CBI. Do not submit this
                                               to stakeholders.                                        identified by docket identification (ID)              information to EPA through
                                                  Further information may be found at:                 number EPA–HQ–OPPT–2017–0144, by                      regulations.gov or email. Clearly mark
                                               http://www.nyiso.com/public/                            one of the following methods:                         the part or all of the information that
                                               committees/documents.jsp?com=mc&                          • Federal eRulemaking Portal: http://               you claim to be CBI. For CBI
                                               directory=2018-02-28                                    www.regulations.gov. Follow the online                information in a disk or CD–ROM that
                                                  The discussions at the meetings                      instructions for submitting comments.                 you mail to EPA, mark the outside of the
                                               described above may address matters at                  Do not submit electronically any                      disk or CD–ROM as CBI and then
                                               issue in the following proceedings:                     information you consider to be                        identify electronically within the disk or
                                                                                                       Confidential Business Information (CBI)               CD–ROM the specific information that
                                               New York Independent System                                                                                   is claimed as CBI. In addition to one
                                                                                                       or other information whose disclosure is
                                                  Operator, Inc., Docket No. ER13–102.                 restricted by statute.                                complete version of the comment that
                                               New York Independent System                               • Mail: Document Control Office                     includes information claimed as CBI, a
                                                  Operator, Inc., Docket No. ER15–                     (7407M), Office of Pollution Prevention               copy of the comment that does not
                                                  2059.                                                and Toxics (OPPT), Environmental                      contain the information claimed as CBI
                                               New York Independent System                             Protection Agency, 1200 Pennsylvania                  must be submitted for inclusion in the
                                                  Operator, Inc., Docket No. ER17–                     Ave. NW, Washington, DC 20460–0001.                   public docket. Information so marked
                                                  2327.                                                  • Hand Delivery: To make special                    will not be disclosed except in
                                                  For more information, contact James                  arrangements for hand delivery or                     accordance with procedures set forth in
                                               Eason, Office of Energy Market                          delivery of boxed information, please                 40 CFR part 2.
                                               Regulation, Federal Energy Regulatory                   follow the instructions at http://                       2. Tips for preparing your comments.
                                               Commission at (202) 502–8622 or                         www.epa.gov/dockets/contacts.html.                    When preparing and submitting your
                                               James.Eason@ferc.gov.                                     Additional instructions on                          comments, see the commenting tips at
                                                 Dated: February 2, 2018.                              commenting or visiting the docket,                    http://www.epa.gov/dockets/
                                                                                                       along with more information about                     comments.html.
                                               Kimberly D. Bose,
                                                                                                       dockets generally, is available at http://
                                               Secretary.                                                                                                    II. Background
                                                                                                       www.epa.gov/dockets.
                                               [FR Doc. 2018–02534 Filed 2–7–18; 8:45 am]
                                                                                                       FOR FURTHER INFORMATION CONTACT: For                  A. TSCA Section 14 Requirement To
                                               BILLING CODE 6717–01–P
                                                                                                       technical information contact: Jessica                Assign a ‘‘Unique Identifier’’
                                                                                                       Barkas, Environmental Assistance
                                                                                                                                                               The June 22, 2016, amendments to
                                                                                                       Division, Office of Pollution Prevention
                                               ENVIRONMENTAL PROTECTION                                                                                      TSCA by the Frank R. Lautenberg
                                                                                                       and Toxics, Environmental Protection
                                               AGENCY                                                                                                        Chemical Safety for the 21st Century
                                                                                                       Agency, 1200 Pennsylvania Ave. NW,
                                                                                                                                                             Act added a requirement in TSCA
                                               [EPA–HQ–OPPT–2017–0144; FRL–9972–94]                    Washington, DC 20460–0001; telephone
                                                                                                                                                             section 14(g)(4) for EPA to, among other
                                                                                                       number: (202) 250–8880; email address:
                                                                                                                                                             things, ‘‘assign a unique identifier to
                                               Assignment and Application of the                       barkas.jessica@epa.gov.
                                                                                                         For general information contact: The                each specific chemical identity for
                                               ‘‘Unique Identifier’’ Under TSCA
                                                                                                       TSCA-Hotline, ABVI-Goodwill, 422                      which the Administrator approves a
                                               Section 14; Notice of Additional
                                                                                                       South Clinton Ave., Rochester, NY                     request for protection from disclosure.’’
                                               Information and Opportunity To
                                                                                                       14620; telephone number: (202) 554–                   EPA is required to use the ‘‘unique
                                               Comment
                                                                                                       1404; email address: TSCA-Hotline@                    identifier assigned under this paragraph
                                               AGENCY: Environmental Protection                        epa.gov.                                              to protect the specific chemical identity
daltland on DSKBBV9HB2PROD with NOTICES




                                               Agency (EPA).                                                                                                 in information that the Administrator
                                                                                                       SUPPLEMENTARY INFORMATION:                            has made public’’ and to ‘‘apply that
                                               ACTION: Notice.
                                                                                                       I. General Information                                identifier consistently to all information
                                               SUMMARY:   Recent amendments to the                                                                           relevant to the applicable chemical
                                               Toxic Substances Control Act (TSCA)                     A. Does this action apply to me?                      substance,’’ including ‘‘any
                                               require EPA to develop a system to                        You may be affected by this action if               nonconfidential information received by
                                               assign a ‘‘unique identifier’’ whenever it              you have submitted or expect to submit                the Administrator with respect to a


                                          VerDate Sep<11>2014   17:18 Feb 07, 2018   Jkt 244001   PO 00000   Frm 00021   Fmt 4703   Sfmt 4703   E:\FR\FM\08FEN1.SGM   08FEN1


                                               5624                        Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Notices

                                               chemical substance . . . while the                      B. Third Alternative Approach                         The UID is applied to that submission
                                               specific chemical identity of the                          Under this approach, EPA would                     as well. Sometime later, Company B
                                               chemical substance is protected from                    assign one unique identifier (UID) per                files a section 8(e) notice on the same
                                               disclosure.’’ 15 U.S.C. 2613(g)(4).                     chemical substance. In most cases EPA                 substance, which it asserts it is using for
                                                  The requirements to assign a unique                  would apply the UID to all non-                       research and development (R&D)
                                               identifier and the unreconciled                         confidential information concerning the               purposes, but does not claim chemical
                                               requirements concerning application of                                                                        identity as CBI. EPA revisits Company
                                                                                                       same chemical substance, from any
                                               the unique identifier and protection of                                                                       A’s original CBI claim and confirms that
                                                                                                       company. However, in a small number
                                               CBI are more fully discussed in the                                                                           it is not expired, has not been
                                                                                                       of cases, EPA would not apply the UID
                                               Federal Register document published                                                                           withdrawn, and has not been denied.
                                                                                                       to some non-confidential documents, in
                                               previously. (See 82 FR 21386; May 8,                                                                          Company B’s submission does not
                                                                                                       order to preserve approved CBI claims
                                               2017; hereafter ‘‘May 8 Federal Register                                                                      reveal that the substance is on the
                                                                                                       for specific chemical identity where the
                                               document’’.) EPA has noted drawbacks                                                                          Inventory or that it is in commerce (as
                                                                                                       non-confidential document itself does
                                               to each of the two alternative                                                                                other than an R&D substance). If EPA
                                                                                                       not undermine the CBI claim, but EPA’s
                                               approaches discussed in the May 8                                                                             applied the UID to Company B’s
                                                                                                       application of the UID to that document
                                               Federal Register document.                                                                                    submission, that act would link
                                                  EPA has developed a third alternative                would result in a linkage that does
                                                                                                                                                             Company B’s section 8(e) notice to
                                               approach for reconciling the competing                  undermine the CBI claim. The basic
                                                                                                                                                             Company A’s NOC, revealing that the
                                               requirements of TSCA section 14(g), and                 criterion for application of the UID to
                                                                                                                                                             specific chemical identity in Company
                                               now invites public comment on this                      submissions made by different
                                                                                                                                                             B’s section 8(e) notice is also the subject
                                               new alternative.                                        submitters is that the Agency’s act of
                                                                                                                                                             of an NOC and has therefore been
                                                  A brief explanation of CBI claims for                applying the UID must not disclose to
                                                                                                                                                             manufactured for commercial purposes,
                                               chemical identity provides context for                  the public the confidential specific                  and is on the Inventory. Thus, EPA’s
                                               understanding the potential effects of                  chemical identity that the UID was                    linkage of the two documents through
                                               applying a unique identifier. TSCA                      assigned to protect.                                  the applied UID—as opposed to any
                                               section 14 permits a person to assert a                    Specifically, prior to applying a UID
                                                                                                                                                             information contained in the non-
                                               CBI claim to seek to protect from public                to public versions of documents
                                                                                                                                                             confidential document itself—would
                                               disclosure certain information in a                     concerning the same substance, and
                                                                                                                                                             undermine the previously approved CBI
                                               submission, including a specific                        filed by different submitters, those
                                                                                                                                                             claim for chemical identity. EPA would
                                               chemical identity. A CBI claim for                      documents would be reviewed for                       not apply the UID to Company B’s
                                               specific chemical identity is intended to               presence of the specific chemical                     submission in this case, to preserve
                                               protect from disclosure the existence of                identity. If the specific chemical                    Company A’s CBI claim.
                                               the chemical substance and/or the fact                  identity (e.g., Chemical Abstracts                       By way of contrast, if Company B’s
                                               that the chemical substance is (or is                   Service (CAS) name or CAS number)                     non-confidential section 8(e) notice
                                               intended to be) manufactured by any                     appears in any of the documents, EPA                  itself revealed that the chemical
                                               person for commercial purposes in the                   would revisit the CBI claim in the                    substance was manufactured for
                                               United States (note that under TSCA,                    remaining document(s) to assure that                  commercial purposes in the United
                                               the term ‘‘manufacture’’ includes                       the claim is unexpired and otherwise                  States—for instance, if the filing were an
                                               import).                                                still valid. If the CBI claim remains                 incident report relating to the
                                                  When a chemical identity on the                      valid, EPA would not apply the UID to                 commercial manufacture or use of that
                                               TSCA Inventory (Inventory) is claimed                   the document that reveals the specific                chemical substance, as opposed to an
                                               as CBI, then the chemical substance is                  chemical identity, in order to preserve               R&D exploration as originally
                                               maintained on the confidential portion                  the CBI claim in the other document(s)                described—then this would indicate
                                               of the Inventory. Conversely, a specific                (if the claim has expired, been                       that Company A’s CBI claim may no
                                               chemical identity that appears on the                   withdrawn, or appears no longer valid,                longer be valid, and EPA would
                                               public portion of the Inventory, and is                 EPA would act in accordance with                      reevaluate the prior CBI claim in
                                               therefore known to be (or to have been)                 section 14(f)(2)(B) and/or 14(g)(4)(D), as            accordance with TSCA section
                                               manufactured for commercial purposes                    appropriate). All of the documents                    14(f)(2)(B) and/or 14(g)(4)(D), as
                                               in the United States, is generally not                  would be available to the public, and                 appropriate.
                                               eligible for confidential protection (see,              the specific chemical identity would be                  EPA expects that exceptions to
                                               e.g., Chemical Data Reporting                           revealed in the document where it was                 application of the UID will be fairly
                                               regulations at 40 CFR 711.30(b)). If                    not claimed as CBI—the document                       rare. For example, in reviewing all non-
                                               another company reveals that they                       revealing the specific chemical identity              confidential section 8(e) submissions
                                               manufacture the substance for                           would simply not be connected by the                  submitted over the past 5 years that
                                               commercial purposes, such as in a non-                  UID to the other document(s) where the                included a CAS number (such that
                                               CBI submission filed under TSCA, the                    specific chemical identity is CBI.                    Inventory status can be readily
                                               chemical identity is no longer eligible                    For example, Company A files a                     checked), EPA found that fewer than
                                               for confidential protection, and a CBI                  Premanufacture Notice (PMN) and later,                4% of these submissions mentioned
                                               claim for chemical identity would be                    a Notice of Commencement (NOC),                       substances that are currently on the
                                               denied upon evaluation. Because the                     claiming chemical identity as CBI to                  confidential portion of the TSCA
                                               meaning of a CBI claim for chemical                     protect from disclosure the fact that the             Inventory. Further, on preliminary
                                               identity is limited, companies that wish                chemical is now being manufactured for                review (i.e., without completing a full
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                                               to protect other information in a                       commercial purposes in the United                     CBI review and determination), it
                                               submission (such as company identity                    States and hence is being added to the                appeared that several of these
                                               or specific information regarding the                   Inventory. EPA approves the CBI claim                 submissions were under circumstances
                                               use, function, or application of that                   and assigns a UID. Company A                          indicating that the original CBI claim
                                               chemical substance) should claim that                   subsequently files a section 8(e) notice              may have been withdrawn or otherwise
                                               specific information as CBI rather than                 concerning the same substance,                        became invalid, suggesting that there
                                               (or in addition to) chemical identity.                  claiming chemical identity as CBI again.              may be even fewer exceptional cases


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                                                                           Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Notices                                            5625

                                               once EPA revisits the original CBI                         This third alternative approach would              ENVIRONMENTAL PROTECTION
                                               claim(s).                                               avoid several problems that EPA has                   AGENCY
                                                  EPA acknowledges that this approach                  identified with assigning more than one
                                               would occasionally create the                                                                                 [EPA–HQ–OPP–2017–0687; FRL–9971–89]
                                                                                                       UID to a single substance (see ‘‘Second
                                               possibility that the application of the                 Alternative Approach,’’ May 8 Federal                 Proposed Information Collection
                                               UID to submissions from two or more                     Register document (at 21389). One such                Request (EPA ICR No. 1204.13);
                                               companies may alert each company to                     problem is that assigning more than one               Comment Request; Submission of
                                               the other’s manufacture of the same                     UID per chemical substance would work                 Unreasonable Adverse Effects
                                               chemical substance. However, such                       against one of the purposes of assigning              Information Under FIFRA Section
                                               disclosures frequently arise in the                     UIDs, to ‘‘provide a specific reference               6(a)(2)
                                               normal course of business under TSCA,                   identifier that protects the
                                               independent of UID. One reason for this                 confidentiality claim to the specific                 AGENCY: Environmental Protection
                                               is that a single accession number is                    chemical identity for the duration of the             Agency (EPA).
                                               typically assigned to each Inventory                    claim, while providing a way for the                  ACTION: Notice.
                                               substance, and the accession number is                  public to identify other filings
                                               often used for subsequent reporting, e.g.,              pertaining to that substance.’’ (See                  SUMMARY:    The Environmental Protection
                                               under the Chemical Data Reporting                       discussion in EPA’s May 8 Federal                     Agency is planning to submit an
                                               (CDR) rule. Accession numbers are also                  Register document (at 21388).) In                     information collection request (ICR),
                                               included alongside other regulatory                     addition, it is unclear how multiple                  ‘‘Submission of Unreasonable Adverse
                                               information, such as relevant section 5                 UIDs per chemical can be reconciled                   Effects Information under FIFRA
                                               significant new use rule (SNUR)                         with the section 8(b)(7) requirement to               Section 6(a)(2)’’ (EPA ICR No. 1204.13,
                                               citations, reported in public databases,                publish and keep current a list of each               OMB Control No. 2070–0039), to the
                                               such as the Substance Registry Service                  confidential Inventory chemical, with                 Office of Management and Budget
                                               (SRS), and in the Inventory file that EPA               its UID, accession number, generic                    (OMB) for review and approval in
                                               makes available to the public                           name, and PMN number, where                           accordance with the Paperwork
                                               (confidential inventory chemicals are                   applicable. Any list that includes all of             Reduction Act. Before doing so, EPA is
                                               listed by PMN number, accession                         this information for each chemical                    soliciting public comments on specific
                                               number, and generic name). (See                         would automatically link submissions                  aspects of the proposed information
                                               https://www.epa.gov/tsca-inventory/                     from different companies by including                 collection as described below. This is a
                                               how-access-tsca-inventory.) Anyone that                 all of the UIDs and/or by using the same              proposed extension of the ICR, which is
                                               has an accession number for a given                     accession number for multiple listings                currently approved through September
                                               confidential inventory substance can                    on the same chemical. (i.e., if Chemical              30, 2018. An Agency may not conduct
                                               query the CDR database and learn                        X has three UIDs, assigned to three                   or sponsor and a person is not required
                                               whether other companies have                            different company claims, they would                  to respond to a collection of information
                                               manufactured the chemical in CDR-                       all be linked on this list, because                   unless it displays a currently valid OMB
                                               reportable amounts, or query the public                 Chemical X only has one accession                     control number.
                                               Inventory to find out the PMN number                    number, and the list is supposed to                   DATES: Comments must be submitted on
                                               of the original submission.                             include both accession number and                     or before April 9, 2018.
                                                  While not every company reports                      UID.) It is also unclear to EPA how                   ADDRESSES: Submit your comments,
                                               under the CDR for every chemical that                   using one UID per chemical, per                       referencing Docket ID No. EPA–HQ–
                                               they manufacture (for example,                          company, would operate in the case that
                                               specialty chemical companies may be                                                                           OPP–2017–0687 online using
                                                                                                       a company or parts of a company                       www.regulations.gov (our preferred
                                               making relatively small quantities of a                 changes ownership; how such UIDs
                                               substance, for a specialized use, and                                                                         method), by email to OPP_Docket@
                                                                                                       would be applied to EPA-generated                     epa.gov, or by mail to: EPA Docket
                                               may not meet the reporting thresholds                   documents that are relevant to more
                                               for CDR), the fact that a chemical                                                                            Center, Environmental Protection
                                                                                                       than one submission; or how the                       Agency, Mail Code 28221T, 1200
                                               substance is on the Inventory can be                    multiple UIDs would be handled in the
                                               revealed in other ways. For example, a                                                                        Pennsylvania Ave. NW, Washington, DC
                                                                                                       case that one company withdraws or                    20460.
                                               company that intends to manufacture a                   permits its CBI claim to expire while the
                                               chemical substance for commercial                                                                                EPA’s policy is that all comments
                                                                                                       other does not. Using one UID per                     received will be included in the public
                                               purposes may file a bona fide                           chemical, and applying that same UID
                                               submission under 40 CFR 720.25 to                                                                             docket without change including any
                                                                                                       to related documents in all but a very                personal information provided, unless
                                               determine whether the chemical                          few exceptional cases, would avoid
                                               substance is already on the Inventory.                                                                        the comment includes profanity, threats,
                                                                                                       these issues.                                         information claimed to be Confidential
                                               The response to the bona fide inquiry,
                                               where EPA tells the submitter whether                   C. Opportunity To Comment on                          Business Information (CBI) or other
                                               a chemical substance is on the                          Approach to Applying the Unique                       information whose disclosure is
                                               confidential portion of the Inventory,                  Identifier                                            restricted by statute.
                                               would indicate whether another                                                                                FOR FURTHER INFORMATION CONTACT:
                                                                                                         EPA invites comment on the possible
                                               company has manufactured the                            approach outlined above.                              Amaris Johnson, Field and External
                                               chemical substance for commercial                                                                             Affairs Division, Office of Pesticide
                                                                                                         Authority: 15 U.S.C. 2613.                          Programs, (7506P), Environmental
                                               purposes in the United States. Also,
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                                               submitters of section 5 notices that are                  Dated: January 26, 2018.                            Protection Agency, 1200 Pennsylvania
                                               subsequently deemed to be invalid                       Charlotte Bertrand,                                   Ave. NW, Washington, DC 20460;
                                               because the substance is already on the                 Acting Principal Deputy Assistant                     telephone number: (703) 305–9542;
                                               Inventory and thus not subject to                       Administrator, Office of Chemical Safety and          email address: johnson.amaris@epa.gov.
                                               section 5 reporting requirements are                    Pollution Prevention.                                 SUPPLEMENTARY INFORMATION:
                                               informed of the Inventory status and are                [FR Doc. 2018–02548 Filed 2–7–18; 8:45 am]               Supporting documents which explain
                                               provided the accession number.                          BILLING CODE 6560–50–P                                in detail the information that the EPA


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Document Created: 2018-02-08 00:16:20
Document Modified: 2018-02-08 00:16:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesEPA will accept written comments and materials submitted to the docket on or before March 12, 2018.
ContactFor 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:
FR Citation83 FR 5623 

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