Assignment and Application of the “Unique Identifier” Under TSCA Section 14; Notice of Public Meeting and Opportunity To Comment, 21386-21389 [2017-09182]
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TABLE 2—LINURON HUMAN HEALTH AND ECOLOGICAL RISK ASSESSMENTS
Registration review case name
and No.
Docket ID No.
Linuron, 0047 ..............................................
EPA–HQ–OPP–2010–0228 ......
III. How should comments, data and
information be submitted?
EPA is providing another opportunity
under 40 CFR 155.53(c) for interested
parties to provide comments and input
concerning the Agency’s draft human
health and ecological risk assessments
for the chemicals identified in this
document. Such comments and input
could address, among other things, the
Agency’s risk assessment methodologies
and assumptions, as applied to a draft
risk assessment. The Agency will
consider all comments received during
the public comment periods and make
changes, as appropriate, to a draft
human health and/or ecological risk
assessment. EPA will then issue a
revised risk assessment, explain any
changes to the draft risk assessment, and
respond to comments.
As indicated in the November 29,
2016 Federal Register document,
anyone may submit data or information
in response to this document. To be
considered during a pesticide’s
registration review, the submitted data
or information must meet the
requirements enumerated in that
document. To submit comments, or
access the dockets, please follow the
detailed instructions provided under
ADDRESSES in the Federal Register
document of November 29, 2016. If you
have questions, consult the persons
listed under FOR FURTHER INFORMATION
CONTACT.
Authority: 7 U.S.C. 136 et seq.
Dated: February 2, 2017,
Yu-Ting Guilaran,
Director, Pesticide Re-Evaluation Division,
Office of Pesticide Programs.
[FR Doc. 2017–09179 Filed 5–5–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[EPA–HQ–OPPT–2017–0144; FRL–9961–30]
Assignment and Application of the
‘‘Unique Identifier’’ Under TSCA
Section 14; Notice of Public Meeting
and Opportunity To Comment
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
Recent amendments to the
Toxic Substances Control Act (TSCA)
SUMMARY:
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Chemical review manager and contact information
Katherine St. Clair, stclair.katherine@epa.gov, 703–347–8778.
require EPA to assign a ‘‘unique
identifier’’ whenever it approves a
Confidential Business Information (CBI)
claim for the specific chemical identity
of a chemical substance, to apply this
unique identifier to other information or
submissions concerning the same
substance, and to ensure that any
nonconfidential information received by
the Agency identifies the chemical
substance using the unique identifier
while the specific chemical identity of
the chemical substance is protected
from disclosure. EPA is requesting
comment on approaches for assigning
and applying unique identifiers. In
addition, EPA invites all interested
parties to attend a public meeting to
provide oral comment.
DATES: Meeting Date: The public
meeting will be held from 1 p.m. to 4
p.m. on May 24, 2017.
Meeting Registration: You may
register online (preferred) or in person
at the meeting. To register online, for
the meeting, go to: https://tsca-uniqueidentifier.eventbrite.com. Advance
registration for the meeting must be
completed no later than May 22, 2017.
On-site registration will be permitted,
but seating and speaking priority will be
given to those who pre-register by the
deadline.
Comments: EPA will hear oral
comments at the meeting, and will
accept written comments and materials
submitted to the docket on or before
July 7, 2017.
ADDRESSES: Meeting: The meeting will
be held at the Ronald Reagan Building
and International Trade Center, in the
Horizon Ballroom, located at 1300
Pennsylvania Avenue Northwest,
Washington, DC 20004. The meeting
will also be available by remote access
for registered participants. Registered
participants will receive information on
how to connect to the meeting prior to
its start.
Comments: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2017–0144, by
one of the following methods:
• Federal eRulemaking Portal: https://
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.
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• 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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
Meeting.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Jessica
Barkas, Environmental Assistance
Division, Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 250–8880; email address:
barkas.jessica@epa.gov.
To request accommodation of a
disability, please contact Jessica Barkas,
preferably at least 10 days prior to the
meeting, to give EPA as much time as
possible to process your request.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCAHotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be affected by this action if
you have or expect to submit
information to EPA under TSCA.
Persons who would use unique
identifiers assigned by the Agency to
seek information may also be affected by
this action. The following list of North
American Industrial Classification
System (NAICS) codes is not intended
to be exhaustive, but rather provides a
guide to help readers determine whether
this document applies to them.
Potentially affected entities may
include:
• Manufacturers, importers, or
processors of chemical substances
(NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum
refineries.
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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
https://www.epa.gov/dockets/
comments.html.
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II. Background
A. TSCA Section 14 Requirement To
Assign a ‘‘Unique Identifier’’
TSCA, as amended June 22, 2016, by
the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, includes
a requirement in section 14(g)(4) for
EPA to, among other things, ‘‘assign a
unique identifier to each specific
chemical identity for which the
Administrator approves a request for
protection from disclosure. . . .’’. EPA
is required to use the ‘‘unique identifier
assigned under this paragraph to protect
the specific chemical identity in
information that the Administrator has
made public’’ and to ‘‘clearly link the
specific chemical identity to the unique
identifier in such information to the
extent practicable.’’ 15 U.S.C.
2613(g)(4).
The full requirements of TSCA
section 14(g)(4) are as follows:
EPA must:
1. Develop a system to assign a unique
identifier to each specific chemical
identity for which the Administrator
approves a request for protection from
disclosure, which shall not be either the
specific chemical identity or a
structurally descriptive generic term.
§ 14(g)(4)(A)(i).
2. Apply that identifier consistently to
all information relevant to the
applicable chemical substance.
§ 14(g)(4)(A)(ii).
3. Annually publish and update a list
of chemical substances, referred to by
their unique identifiers, for which
claims to protect the specific chemical
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identity from disclosure have been
approved, including the expiration date
for each such claim. § 14(g)(4)(B).
4. Ensure that any nonconfidential
information received by the
Administrator with respect to a
chemical substance included on that list
while the specific chemical identity of
the chemical substance is protected
from disclosure under TSCA section 14
identifies the chemical substance using
the unique identifier. § 14(g)(4)(C).
5. For each claim for protection of a
specific chemical identity that has been
denied by the Administrator or expired,
or that has been withdrawn by the
person who asserted the claim, and for
which the Administrator has used a
unique identifier assigned under
§ 14(g)(4) to protect the specific
chemical identity in information that
the Administrator has made public,
clearly link the specific chemical
identity to the unique identifier in such
information to the extent practicable.
§ 14(g)(4)(D).
B. Assigning the Unique Identifier
The identifier cannot be the specific
chemical identity, or a structurally
descriptive generic term. TSCA section
14(a)(4)(A)(i). Consequently, EPA must
develop a system to assign such
identifiers for each substance for which
it makes a final determination
approving a CBI claim for specific
chemical identity. EPA is considering
using a numeric identifier, which will
incorporate the year the claim was
approved. Including this date will
facilitate tracking of the expiration of
the CBI claims for specific chemical
identity made in that document,
pursuant to TSCA section 14(f)(3). EPA
considered using a pre-existing
identifier, specifically accession
numbers, but language in TSCA section
8(b)(7)(B) suggests that accession
numbers were intended to be distinct
from the unique identifier (15 U.S.C.
2607(b)(7)(B)), and expanding the use of
accession numbers beyond their current
use and purpose could be confusing
(accession numbers are currently
assigned following a notice of
commencement of commercial
manufacture or import under section 5,
and identify chemicals that are or were
formerly on the confidential portion of
the TSCA Inventory, while the unique
identifier is an outcome of a CBI
determination under section 14—at this
stage, very few chemicals with
accession numbers have been subject to
this new CBI review requirement, so the
fact that a substance is identified using
an accession number would not indicate
anything reliable about whether
chemical identity claims concerning the
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substance had been reviewed (let alone
when they might expire)).
C. Application of the Unique Identifier
Once the unique identifier is
assigned, section 14(g)(4)(A)(ii) requires
that EPA apply it to ‘‘all information
relevant to the applicable chemical
substance.’’ Section 14(g)(4)(C) instructs
that any nonconfidential information
received with respect to the chemical
substance ‘‘while the specific chemical
identity of the chemical substance is
protected from disclosure,’’ identify the
chemical substance using the unique
identifier. In addition, section
14(g)(4)(D) requires that after the
underlying CBI claim for specific
chemical identity expires, is denied by
EPA, or is withdrawn, specific chemical
identity be ‘‘clearly link[ed]’’ to the
unique identifier in public documents
that previously used the unique
identifier to ‘‘protect the specific
chemical identity in information that
the Administrator has made public.’’
The two general requirements, (1)
applying the unique identifier to other,
non-confidential information
concerning that substance (section
14(g)(4)(A)(ii) and (C)); and (2) ‘‘while
the specific chemical identity is
protected from disclosure,’’ using the
unique identifier in a manner that
would ‘‘protect the specific chemical
identity in information that the
Administrator has made public,’’
(section 14(g)(4)(C) and (D)), do not
appear to be completely reconciled in
the statute. EPA has identified several
situations where applying the same
unique identifier to every instance
where information pertaining to the
same chemical substance is reported
under TSCA could cause CBI, including
specific chemical identity, to be
revealed.
The intent of Congress with respect to
the protection of confidential chemical
identities is explicit in the legislative
history: ‘‘The Committee expects that
redactions or the use of approved
generic names or unique identifiers will
be employed to meaningfully inform the
public without comprising [sic] trade
secrets.’’ H.R. Rep. No.114–176, at 30
(2015). Yet the specific instructions in
section 14(g)(4) regarding assigning,
applying, publishing and using the
unique identifier would in some cases
seem to disclose the very CBI that
Congress has directed EPA to protect.
Following is a more detailed discussion
of the statutory provision. EPA desires
comment on how to reconcile the
different objectives of the provision.
TSCA section 14(g)(4)(A)(ii) states
that EPA shall apply the unique
identifier ‘‘consistently to all
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information relevant to the applicable
chemical substance.’’ Section 14(g)(4)(C)
states that EPA shall ‘‘ensure that any
nonconfidential information . . . with
respect to a chemical substance’’ for
which a unique identifier has been
assigned ‘‘identifies the chemical
substance using the unique identifier.’’
Reading these words in isolation
suggests that a particular chemical
substance would have a single unique
identifier, assigned the first time EPA
makes a final determination concerning
a CBI claim to protect the specific
chemical identity of that substance, and
applied to public versions of other
filings pertaining to that substance.
Section 14(g)(4)(A)(ii) and (C). Further,
if the CBI claim is later denied, expires,
or is withdrawn, EPA is required (to the
extent practicable) to clearly link the
specific chemical identity to the unique
identifier in any information that it has
made public that used the unique
identifier to protect the specific
chemical identity. § 14(g)(4)(D). The
purpose of the unique identifier is to
provide a specific reference identifier
that protects the confidentiality claim to
the specific chemical identity for the
duration of the claim, while providing
a way for the public to identify other
filings pertaining to that substance.
However, having a single unique
identifier that is publicly applied to
every submission containing that
chemical identity and used for every
instance in which there is
nonconfidential information concerning
that chemical substance may cause CBI
to be revealed to one or more other
parties (or the public at large), in some
circumstances the specific chemical
identity that EPA has determined is
entitled to confidential treatment, and
which was intended to be protected as
noted in section 14(g)(4)(C) and (D).
If documents concerning the same
substance, submitted by different
companies, at different times, and for
different purposes, were to always be
assigned the same unique identifier,
then each company could learn that the
substance was marketed in the United
States by another company, and
possibly learn of new uses and other
information concerning the substance.
Thus, one of the rationales for a CBI
claim for specific chemical identity, i.e.,
that the chemical substance is
manufactured for commercial purposes
in the United States, might be disclosed
to competitors, undermining the
protection of that specific chemical
identity that is part of the purpose for
section 14(g)(4).
Example 1: Company A files a
Premanufacture Notice (PMN) and later
commences import of Chemical X, for
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which its CBI claim for chemical
identity is approved by EPA, resulting in
Chemical X being placed on the
confidential portion of the TSCA
Inventory. Company B subsequently
files a notice of substantial risk under
TSCA section 8(e) on the same
substance, which it is utilizing for
research and development, also
claiming chemical identity as CBI. EPA
approves this claim and assigns the
same unique identifier.
By connecting submissions from
different companies with the unique
identifier, Company B can determine
the confidential information that
Chemical X is in US commerce (without
having to submit and meet the terms of
a bona fide request under 40 CFR
720.25). Both companies can now
determine that another company has an
active interest in the same chemical.
Both companies also can determine any
non-CBI information about the other
company, uses, or other information
that might be in the other submission.
Further, if the specific chemical
identity is not uniformly claimed as CBI
in all such submissions, applying the
unique identifier to a submission with
a non-confidential chemical identity
effectively destroys the CBI claim for
chemical identity in all other
documents that use the same unique
identifier. E.g., in Example 1, if
Company B chose to not claim chemical
identity as CBI in its section 8(e) filing
regarding an R & D use, and EPA
applied the unique identifier to the
section 8(e) submission, this submission
could be readily linked to Company A’s
submission, and the confidential
chemical identity in Company A’s
submission would be revealed to the
public, along with the fact that
Chemical X is in commerce in the
United States.
There are additional circumstances
where the action or inaction of one
company could cause the CBI of another
company to be revealed:
Example 2: EPA receives and
approves Company A’s CBI claim for
chemical identity in a Notice of
Commencement (NOC). The substance
is placed on the confidential portion of
the Inventory and a unique identifier is
assigned. Subsequently, Company B
files a bona fide notice concerning the
same substance. Company B does not
claim chemical identity as CBI. In
accordance with section 14(g)(4)(C),
EPA applies the unique identifier to the
public version of the bona fide
submission.
Applying the unique identifier to the
bona fide submission effectively
discloses the identity of Company A’s
chemical, and reveals that the substance
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is in US commerce. Because it is now
not a secret that the substance is in US
commerce, the substance would be
removed from the confidential portion
of the Inventory, and all information
concerning uses, company identity, and
other information that was not claimed
as CBI in the underlying PMN, NOC,
and the bona fide notice could be linked
together, potentially further disclosing
information about the chemical that the
other company may have claimed as
confidential.
Alternative Approaches
Following are two alternative
approaches to applying the unique
identifier to other submissions for the
same chemical substance to
meaningfully inform the public without
compromising trade secrets. These
approaches are intended to give the
greatest possible effect to the language
of section 14(g)(4) concerning the
application of the unique identifier to
related submissions, while (also in
accordance with section 14(g)(4))
maintaining the EPA-approved
confidentiality of certain chemical
identities. EPA invites comments on
applying the unique identifier to all
submissions containing a particular
chemical substance and on these
alternative approaches, as well as
suggestions for other possible
approaches.
First Alternative
There are readings of section 14(g)(4)
that may avoid or ameliorate what are
otherwise contradictory instructions.
For example, section 14(g)(4)(C) may
plausibly be read as instructing EPA to
ensure that any non-confidential
information received by EPA concerning
a confidential chemical substance
should identify the substance using only
the unique identifier, so long as the
confidential identity remains protected
from disclosure. In this way, the public
(including other companies) could
identify the various submissions
concerning a particular chemical, but
could not identify the specific chemical.
However, the fact that information not
claimed as confidential would need to
be treated as such might be viewed as
inconsistent with policy (as reflected in
the FOIA and in TSCA amendments) to
limit CBI protection to relatively narrow
set of circumstances. This option also
presents a number of implementation
challenges. For example, this approach
would require EPA to carefully screen
incoming, non-CBI submissions against
its list of confidential chemical names,
and to treat as CBI information to which
no such claim was made, a process that
carries considerable risk of error.
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Further, the facts of a specific case may
affect whether the original, unaltered
and non-CBI submissions could be
prevented from release pursuant to a
Freedom of Information Act (FOIA)
request. Finally, screening and redacting
submissions in this way may be such a
burden on EPA resources as to be
impracticable.
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Second Alternative
Under this approach, unique
identifiers, once assigned, are applied to
other submissions concerning that
chemical substance, but only those that
are submitted by the same person/
company. Additional submissions
concerning the same substance that are
submitted by a different company
would be assigned a different unique
identifier. The unique identifier would
not be applied to or associated with
non-confidential information if the
effect of that application would be to
reveal the identity of an approved
confidential chemical that is otherwise
protected from disclosure under section
14. The public would be able to link
some submissions on the same
chemical, but not necessarily all
submissions on that chemical.
The public could use generic
identities and the identities provided in
non-confidential filings to group
together submissions on similar
chemicals, but would not be able to tell,
with certainty, whether filings bearing
different unique identifiers pertain to
the same chemical or two different
chemicals with generically similar
structures. This option at least partly
fulfills the intent to link information
concerning the same substance, while
maintaining the approved
confidentiality claims of each submitter,
until such claims are withdrawn, expire,
or are subsequently denied by EPA. At
that time, EPA would then append or
otherwise make known to the public the
specific identity that corresponds to the
unique identifier used in such filings, in
accordance with section 14(g)(4)(D).
EPA notes that this alternative is
consistent with EPA’s history of
reconciling ambiguities and apparent
contradictions concerning TSCA
confidentiality. Since the inception of
TSCA, the Agency has needed to
balance the requirements and interests
in protecting confidentiality with the
requirements and interests in public
disclosure of chemical information. For
example, in the preamble to the final
rule establishing the initial TSCA
Inventory, EPA discussed an apparent
conflict between TSCA sections 8(b) and
5(a)’s requirements to include certain
chemical identities on the Inventory (to
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publish a list of ‘‘each chemical
substance which is manufactured in the
United States,’’ including ‘‘each
chemical substance which any person
reports under section 5’’), and section
14’s requirement that information
exempt from disclosure under FOIA
exemption 4 (5 U.S.C. 552(b)(4)) not be
disclosed except in accordance with
section 14(a) and (b). 42 FR 64573
(December 23, 1977). EPA ultimately
resolved this apparent conflict by
attempting to balance the competing
concerns (informing the public and
defining what is a new chemical under
TSCA, versus protecting CBI and trade
secrets) by creating a confidential
portion of the Inventory, and setting up
the bona fide inquiry process to permit
limited disclosure of CBI to individual
companies seeking to determine
whether they are required to file a PMN.
Another example can be found in the
preamble to the final rule implementing
section 12(b) of TSCA, the export
notification requirements. 45 FR 82847
(December 16, 1980). Section 12(b)
requires EPA to report certain specific
chemical identities to certain foreign
governments under specified
circumstances. Section 14(b) prohibits
disclosure of information claimed as
CBI except under specified
circumstances, such that it appeared
that EPA could not report the
information required under section
12(b) without violating section 14.
Reasoning that because the statute must
be interpreted to give the fullest
possible effect to both sections, EPA
concluded that section 12(b) requires
the notification to foreign governments,
even if the chemical identity is
confidential, but prohibits disclosure of
such confidential information to other
persons. Otherwise, the notification
required by section 12(b) would be
meaningless and not carry out the
purpose of the section.
D. Opportunity To Comment on
Approach To Applying the Unique
Identifier
In addition to general comments on
the possible approaches outlined above,
EPA invites comment on other
suggested approaches.
III. Meeting
The meeting will be accessible
remotely for registered participants.
Registered participants will receive
information on how to connect remotely
to the meeting prior to its start.
Frm 00026
B. Public Participation at the Meeting
Anyone may register to attend the
meeting as observers and may also
register to provide oral comments on the
day of the meeting. A registered speaker
is encouraged to focus on issues directly
relevant to the meeting’s subject matter.
Based on level of interest in speaking,
each speaker may be limited to five
minutes to provide oral comments. To
accommodate as many registered
speakers as possible, speakers may
present oral comments only, without
visual aids or written material.
C. Submitting Written Materials
Anyone may submit written materials
to the docket as described under
ADDRESSES.
IV. How can I request to participate in
the meeting?
A. Registration
To attend the meeting in person or to
receive remote access, you must register
no later than May 22, 2017, using the
method described under DATES. While
on-site registration will be available,
seating will be on a first-come, firstserved basis, with priority given to early
registrants, until room capacity is
reached. The Agency anticipates that
approximately 150 people will be able
to attend the meeting in person. For
registrants not able to attend in person,
the meeting will also provide remote
access capabilities; registered
participants will be provided
information on how to connect to the
meeting prior to its start.
B. Required Registration Information
Members of the public may register to
attend as observers or speak if planning
to offer oral comments during the
scheduled public comment period. To
register for the meeting online, you must
provide your full name, organization or
affiliation, and contact information to
the on-line signup. Do not submit any
information in your request that is
considered CBI. Requests to participate
in the meeting, identified by docket ID
No. EPA–HQ–OPPT–2017–0144, must
be received on or before May 22, 2017.
Authority: 15 U.S.C. 2613.
A. Remote Access
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Dated: April 21, 2017.
Louise P. Wise,
Acting Assistant Administrator, Office of
Chemical Safety and Pollution Prevention.
[FR Doc. 2017–09182 Filed 5–5–17; 8:45 am]
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Agencies
[Federal Register Volume 82, Number 87 (Monday, May 8, 2017)]
[Notices]
[Pages 21386-21389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09182]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2017-0144; FRL-9961-30]
Assignment and Application of the ``Unique Identifier'' Under
TSCA Section 14; Notice of Public Meeting and Opportunity To Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Recent amendments to the Toxic Substances Control Act (TSCA)
require EPA to assign a ``unique identifier'' whenever it approves a
Confidential Business Information (CBI) claim for the specific chemical
identity of a chemical substance, to apply this unique identifier to
other information or submissions concerning the same substance, and to
ensure that any nonconfidential information received by the Agency
identifies the chemical substance using the unique identifier while the
specific chemical identity of the chemical substance is protected from
disclosure. EPA is requesting comment on approaches for assigning and
applying unique identifiers. In addition, EPA invites all interested
parties to attend a public meeting to provide oral comment.
DATES: Meeting Date: The public meeting will be held from 1 p.m. to 4
p.m. on May 24, 2017.
Meeting Registration: You may register online (preferred) or in
person at the meeting. To register online, for the meeting, go to:
https://tsca-unique-identifier.eventbrite.com. Advance registration for
the meeting must be completed no later than May 22, 2017. On-site
registration will be permitted, but seating and speaking priority will
be given to those who pre-register by the deadline.
Comments: EPA will hear oral comments at the meeting, and will
accept written comments and materials submitted to the docket on or
before July 7, 2017.
ADDRESSES: Meeting: The meeting will be held at the Ronald Reagan
Building and International Trade Center, in the Horizon Ballroom,
located at 1300 Pennsylvania Avenue Northwest, Washington, DC 20004.
The meeting will also be available by remote access for registered
participants. Registered participants will receive information on how
to connect to the meeting prior to its start.
Comments: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2017-0144, by one of the following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
Meeting.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Jessica Barkas, Environmental Assistance Division, Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 250-8880; email address: barkas.jessica@epa.gov.
To request accommodation of a disability, please contact Jessica
Barkas, preferably at least 10 days prior to the meeting, to give EPA
as much time as possible to process your request.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be affected by this action if you have or expect to submit
information to EPA under TSCA. Persons who would use unique identifiers
assigned by the Agency to seek information may also be affected by this
action. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers, importers, or processors of chemical
substances (NAICS codes 325 and 324110), e.g., chemical manufacturing
and petroleum refineries.
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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 https://www.epa.gov/dockets/comments.html.
II. Background
A. TSCA Section 14 Requirement To Assign a ``Unique Identifier''
TSCA, as amended June 22, 2016, by the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, includes a requirement in section
14(g)(4) for EPA to, among other things, ``assign a unique identifier
to each specific chemical identity for which the Administrator approves
a request for protection from disclosure. . . .''. EPA is required to
use the ``unique identifier assigned under this paragraph to protect
the specific chemical identity in information that the Administrator
has made public'' and to ``clearly link the specific chemical identity
to the unique identifier in such information to the extent
practicable.'' 15 U.S.C. 2613(g)(4).
The full requirements of TSCA section 14(g)(4) are as follows:
EPA must:
1. Develop a system to assign a unique identifier to each specific
chemical identity for which the Administrator approves a request for
protection from disclosure, which shall not be either the specific
chemical identity or a structurally descriptive generic term. Sec.
14(g)(4)(A)(i).
2. Apply that identifier consistently to all information relevant
to the applicable chemical substance. Sec. 14(g)(4)(A)(ii).
3. Annually publish and update a list of chemical substances,
referred to by their unique identifiers, for which claims to protect
the specific chemical identity from disclosure have been approved,
including the expiration date for each such claim. Sec. 14(g)(4)(B).
4. Ensure that any nonconfidential information received by the
Administrator with respect to a chemical substance included on that
list while the specific chemical identity of the chemical substance is
protected from disclosure under TSCA section 14 identifies the chemical
substance using the unique identifier. Sec. 14(g)(4)(C).
5. For each claim for protection of a specific chemical identity
that has been denied by the Administrator or expired, or that has been
withdrawn by the person who asserted the claim, and for which the
Administrator has used a unique identifier assigned under Sec.
14(g)(4) to protect the specific chemical identity in information that
the Administrator has made public, clearly link the specific chemical
identity to the unique identifier in such information to the extent
practicable. Sec. 14(g)(4)(D).
B. Assigning the Unique Identifier
The identifier cannot be the specific chemical identity, or a
structurally descriptive generic term. TSCA section 14(a)(4)(A)(i).
Consequently, EPA must develop a system to assign such identifiers for
each substance for which it makes a final determination approving a CBI
claim for specific chemical identity. EPA is considering using a
numeric identifier, which will incorporate the year the claim was
approved. Including this date will facilitate tracking of the
expiration of the CBI claims for specific chemical identity made in
that document, pursuant to TSCA section 14(f)(3). EPA considered using
a pre-existing identifier, specifically accession numbers, but language
in TSCA section 8(b)(7)(B) suggests that accession numbers were
intended to be distinct from the unique identifier (15 U.S.C.
2607(b)(7)(B)), and expanding the use of accession numbers beyond their
current use and purpose could be confusing (accession numbers are
currently assigned following a notice of commencement of commercial
manufacture or import under section 5, and identify chemicals that are
or were formerly on the confidential portion of the TSCA Inventory,
while the unique identifier is an outcome of a CBI determination under
section 14--at this stage, very few chemicals with accession numbers
have been subject to this new CBI review requirement, so the fact that
a substance is identified using an accession number would not indicate
anything reliable about whether chemical identity claims concerning the
substance had been reviewed (let alone when they might expire)).
C. Application of the Unique Identifier
Once the unique identifier is assigned, section 14(g)(4)(A)(ii)
requires that EPA apply it to ``all information relevant to the
applicable chemical substance.'' Section 14(g)(4)(C) instructs that any
nonconfidential information received with respect to the chemical
substance ``while the specific chemical identity of the chemical
substance is protected from disclosure,'' identify the chemical
substance using the unique identifier. In addition, section 14(g)(4)(D)
requires that after the underlying CBI claim for specific chemical
identity expires, is denied by EPA, or is withdrawn, specific chemical
identity be ``clearly link[ed]'' to the unique identifier in public
documents that previously used the unique identifier to ``protect the
specific chemical identity in information that the Administrator has
made public.''
The two general requirements, (1) applying the unique identifier to
other, non-confidential information concerning that substance (section
14(g)(4)(A)(ii) and (C)); and (2) ``while the specific chemical
identity is protected from disclosure,'' using the unique identifier in
a manner that would ``protect the specific chemical identity in
information that the Administrator has made public,'' (section
14(g)(4)(C) and (D)), do not appear to be completely reconciled in the
statute. EPA has identified several situations where applying the same
unique identifier to every instance where information pertaining to the
same chemical substance is reported under TSCA could cause CBI,
including specific chemical identity, to be revealed.
The intent of Congress with respect to the protection of
confidential chemical identities is explicit in the legislative
history: ``The Committee expects that redactions or the use of approved
generic names or unique identifiers will be employed to meaningfully
inform the public without comprising [sic] trade secrets.'' H.R. Rep.
No.114-176, at 30 (2015). Yet the specific instructions in section
14(g)(4) regarding assigning, applying, publishing and using the unique
identifier would in some cases seem to disclose the very CBI that
Congress has directed EPA to protect. Following is a more detailed
discussion of the statutory provision. EPA desires comment on how to
reconcile the different objectives of the provision.
TSCA section 14(g)(4)(A)(ii) states that EPA shall apply the unique
identifier ``consistently to all
[[Page 21388]]
information relevant to the applicable chemical substance.'' Section
14(g)(4)(C) states that EPA shall ``ensure that any nonconfidential
information . . . with respect to a chemical substance'' for which a
unique identifier has been assigned ``identifies the chemical substance
using the unique identifier.'' Reading these words in isolation
suggests that a particular chemical substance would have a single
unique identifier, assigned the first time EPA makes a final
determination concerning a CBI claim to protect the specific chemical
identity of that substance, and applied to public versions of other
filings pertaining to that substance. Section 14(g)(4)(A)(ii) and (C).
Further, if the CBI claim is later denied, expires, or is withdrawn,
EPA is required (to the extent practicable) to clearly link the
specific chemical identity to the unique identifier in any information
that it has made public that used the unique identifier to protect the
specific chemical identity. Sec. 14(g)(4)(D). The purpose of the
unique identifier is to provide a specific reference identifier that
protects the confidentiality claim to the specific chemical identity
for the duration of the claim, while providing a way for the public to
identify other filings pertaining to that substance.
However, having a single unique identifier that is publicly applied
to every submission containing that chemical identity and used for
every instance in which there is nonconfidential information concerning
that chemical substance may cause CBI to be revealed to one or more
other parties (or the public at large), in some circumstances the
specific chemical identity that EPA has determined is entitled to
confidential treatment, and which was intended to be protected as noted
in section 14(g)(4)(C) and (D).
If documents concerning the same substance, submitted by different
companies, at different times, and for different purposes, were to
always be assigned the same unique identifier, then each company could
learn that the substance was marketed in the United States by another
company, and possibly learn of new uses and other information
concerning the substance. Thus, one of the rationales for a CBI claim
for specific chemical identity, i.e., that the chemical substance is
manufactured for commercial purposes in the United States, might be
disclosed to competitors, undermining the protection of that specific
chemical identity that is part of the purpose for section 14(g)(4).
Example 1: Company A files a Premanufacture Notice (PMN) and later
commences import of Chemical X, for which its CBI claim for chemical
identity is approved by EPA, resulting in Chemical X being placed on
the confidential portion of the TSCA Inventory. Company B subsequently
files a notice of substantial risk under TSCA section 8(e) on the same
substance, which it is utilizing for research and development, also
claiming chemical identity as CBI. EPA approves this claim and assigns
the same unique identifier.
By connecting submissions from different companies with the unique
identifier, Company B can determine the confidential information that
Chemical X is in US commerce (without having to submit and meet the
terms of a bona fide request under 40 CFR 720.25). Both companies can
now determine that another company has an active interest in the same
chemical. Both companies also can determine any non-CBI information
about the other company, uses, or other information that might be in
the other submission.
Further, if the specific chemical identity is not uniformly claimed
as CBI in all such submissions, applying the unique identifier to a
submission with a non-confidential chemical identity effectively
destroys the CBI claim for chemical identity in all other documents
that use the same unique identifier. E.g., in Example 1, if Company B
chose to not claim chemical identity as CBI in its section 8(e) filing
regarding an R & D use, and EPA applied the unique identifier to the
section 8(e) submission, this submission could be readily linked to
Company A's submission, and the confidential chemical identity in
Company A's submission would be revealed to the public, along with the
fact that Chemical X is in commerce in the United States.
There are additional circumstances where the action or inaction of
one company could cause the CBI of another company to be revealed:
Example 2: EPA receives and approves Company A's CBI claim for
chemical identity in a Notice of Commencement (NOC). The substance is
placed on the confidential portion of the Inventory and a unique
identifier is assigned. Subsequently, Company B files a bona fide
notice concerning the same substance. Company B does not claim chemical
identity as CBI. In accordance with section 14(g)(4)(C), EPA applies
the unique identifier to the public version of the bona fide
submission.
Applying the unique identifier to the bona fide submission
effectively discloses the identity of Company A's chemical, and reveals
that the substance is in US commerce. Because it is now not a secret
that the substance is in US commerce, the substance would be removed
from the confidential portion of the Inventory, and all information
concerning uses, company identity, and other information that was not
claimed as CBI in the underlying PMN, NOC, and the bona fide notice
could be linked together, potentially further disclosing information
about the chemical that the other company may have claimed as
confidential.
Alternative Approaches
Following are two alternative approaches to applying the unique
identifier to other submissions for the same chemical substance to
meaningfully inform the public without compromising trade secrets.
These approaches are intended to give the greatest possible effect to
the language of section 14(g)(4) concerning the application of the
unique identifier to related submissions, while (also in accordance
with section 14(g)(4)) maintaining the EPA-approved confidentiality of
certain chemical identities. EPA invites comments on applying the
unique identifier to all submissions containing a particular chemical
substance and on these alternative approaches, as well as suggestions
for other possible approaches.
First Alternative
There are readings of section 14(g)(4) that may avoid or ameliorate
what are otherwise contradictory instructions. For example, section
14(g)(4)(C) may plausibly be read as instructing EPA to ensure that any
non-confidential information received by EPA concerning a confidential
chemical substance should identify the substance using only the unique
identifier, so long as the confidential identity remains protected from
disclosure. In this way, the public (including other companies) could
identify the various submissions concerning a particular chemical, but
could not identify the specific chemical.
However, the fact that information not claimed as confidential
would need to be treated as such might be viewed as inconsistent with
policy (as reflected in the FOIA and in TSCA amendments) to limit CBI
protection to relatively narrow set of circumstances. This option also
presents a number of implementation challenges. For example, this
approach would require EPA to carefully screen incoming, non-CBI
submissions against its list of confidential chemical names, and to
treat as CBI information to which no such claim was made, a process
that carries considerable risk of error.
[[Page 21389]]
Further, the facts of a specific case may affect whether the original,
unaltered and non-CBI submissions could be prevented from release
pursuant to a Freedom of Information Act (FOIA) request. Finally,
screening and redacting submissions in this way may be such a burden on
EPA resources as to be impracticable.
Second Alternative
Under this approach, unique identifiers, once assigned, are applied
to other submissions concerning that chemical substance, but only those
that are submitted by the same person/company. Additional submissions
concerning the same substance that are submitted by a different company
would be assigned a different unique identifier. The unique identifier
would not be applied to or associated with non-confidential information
if the effect of that application would be to reveal the identity of an
approved confidential chemical that is otherwise protected from
disclosure under section 14. The public would be able to link some
submissions on the same chemical, but not necessarily all submissions
on that chemical.
The public could use generic identities and the identities provided
in non-confidential filings to group together submissions on similar
chemicals, but would not be able to tell, with certainty, whether
filings bearing different unique identifiers pertain to the same
chemical or two different chemicals with generically similar
structures. This option at least partly fulfills the intent to link
information concerning the same substance, while maintaining the
approved confidentiality claims of each submitter, until such claims
are withdrawn, expire, or are subsequently denied by EPA. At that time,
EPA would then append or otherwise make known to the public the
specific identity that corresponds to the unique identifier used in
such filings, in accordance with section 14(g)(4)(D).
EPA notes that this alternative is consistent with EPA's history of
reconciling ambiguities and apparent contradictions concerning TSCA
confidentiality. Since the inception of TSCA, the Agency has needed to
balance the requirements and interests in protecting confidentiality
with the requirements and interests in public disclosure of chemical
information. For example, in the preamble to the final rule
establishing the initial TSCA Inventory, EPA discussed an apparent
conflict between TSCA sections 8(b) and 5(a)'s requirements to include
certain chemical identities on the Inventory (to publish a list of
``each chemical substance which is manufactured in the United States,''
including ``each chemical substance which any person reports under
section 5''), and section 14's requirement that information exempt from
disclosure under FOIA exemption 4 (5 U.S.C. 552(b)(4)) not be disclosed
except in accordance with section 14(a) and (b). 42 FR 64573 (December
23, 1977). EPA ultimately resolved this apparent conflict by attempting
to balance the competing concerns (informing the public and defining
what is a new chemical under TSCA, versus protecting CBI and trade
secrets) by creating a confidential portion of the Inventory, and
setting up the bona fide inquiry process to permit limited disclosure
of CBI to individual companies seeking to determine whether they are
required to file a PMN.
Another example can be found in the preamble to the final rule
implementing section 12(b) of TSCA, the export notification
requirements. 45 FR 82847 (December 16, 1980). Section 12(b) requires
EPA to report certain specific chemical identities to certain foreign
governments under specified circumstances. Section 14(b) prohibits
disclosure of information claimed as CBI except under specified
circumstances, such that it appeared that EPA could not report the
information required under section 12(b) without violating section 14.
Reasoning that because the statute must be interpreted to give the
fullest possible effect to both sections, EPA concluded that section
12(b) requires the notification to foreign governments, even if the
chemical identity is confidential, but prohibits disclosure of such
confidential information to other persons. Otherwise, the notification
required by section 12(b) would be meaningless and not carry out the
purpose of the section.
D. Opportunity To Comment on Approach To Applying the Unique Identifier
In addition to general comments on the possible approaches outlined
above, EPA invites comment on other suggested approaches.
III. Meeting
A. Remote Access
The meeting will be accessible remotely for registered
participants. Registered participants will receive information on how
to connect remotely to the meeting prior to its start.
B. Public Participation at the Meeting
Anyone may register to attend the meeting as observers and may also
register to provide oral comments on the day of the meeting. A
registered speaker is encouraged to focus on issues directly relevant
to the meeting's subject matter. Based on level of interest in
speaking, each speaker may be limited to five minutes to provide oral
comments. To accommodate as many registered speakers as possible,
speakers may present oral comments only, without visual aids or written
material.
C. Submitting Written Materials
Anyone may submit written materials to the docket as described
under ADDRESSES.
IV. How can I request to participate in the meeting?
A. Registration
To attend the meeting in person or to receive remote access, you
must register no later than May 22, 2017, using the method described
under DATES. While on-site registration will be available, seating will
be on a first-come, first-served basis, with priority given to early
registrants, until room capacity is reached. The Agency anticipates
that approximately 150 people will be able to attend the meeting in
person. For registrants not able to attend in person, the meeting will
also provide remote access capabilities; registered participants will
be provided information on how to connect to the meeting prior to its
start.
B. Required Registration Information
Members of the public may register to attend as observers or speak
if planning to offer oral comments during the scheduled public comment
period. To register for the meeting online, you must provide your full
name, organization or affiliation, and contact information to the on-
line signup. Do not submit any information in your request that is
considered CBI. Requests to participate in the meeting, identified by
docket ID No. EPA-HQ-OPPT-2017-0144, must be received on or before May
22, 2017.
Authority: 15 U.S.C. 2613.
Dated: April 21, 2017.
Louise P. Wise,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2017-09182 Filed 5-5-17; 8:45 am]
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