TSCA Inventory Notification (Active-Inactive) Requirements, 4255-4269 [2016-31923]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Proposed Rules]
[Pages 4255-4269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31923]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 710

[EPA-HQ-OPPT-2016-0426; FRL-9956-28]
RIN 2070-AK24


TSCA Inventory Notification (Active-Inactive) Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The recent amendments to the Toxic Substances Control Act 
(TSCA) require EPA to designate chemical substances on the TSCA 
Chemical Substance Inventory as either ``active'' or ``inactive'' in 
U.S. commerce. To accomplish that, EPA is proposing to require a 
retrospective electronic notification of chemical substances on the 
TSCA Inventory that were manufactured (including imported) for non-
exempt commercial purposes during the ten-year time period ending on 
June 21, 2016. EPA would also accept such notices for chemical 
substances that were processed. EPA would use these notifications to 
distinguish active substances from inactive substances. EPA would 
include the active and inactive designations on the TSCA Inventory and 
as part of its regular publications of the Inventory. EPA is also 
proposing to establish procedures for forward-looking electronic 
notification of chemical substances on the TSCA Inventory that are 
designated as inactive, if and when the manufacturing or processing of 
such chemical substances for non-exempt commercial purposes is expected 
to resume. Upon receipt of a valid notice, EPA would change the 
designation of the pertinent chemical substance on the TSCA Inventory 
from inactive to active. EPA is proposing the procedures regarding the 
manner in which such retrospective and forward-looking activity 
notifications must be submitted, the details of the notification 
requirements, exemptions from such requirements, and procedures for 
handling claims of confidentiality.

DATES: Comments must be received on or before March 14, 2017.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2016-0426, 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.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Myrta R. Christian, Chemistry, 
Economics, and Sustainable Strategies Division (Mailcode 7401M), Office 
of Pollution Prevention and Toxics, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (202) 564-8498; email address: christian.myrta@epa.gov.
    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. Executive Summary

A. Does this action apply to me?

    You may be affected by this action if you domestically 
manufactured, imported, or processed chemical substances listed on the 
TSCA Chemical Substance Inventory for nonexempt commercial purposes 
during the ten-year time period ending on June 21,

[[Page 4256]]

2016. You may also be affected by this action if you intend to 
domestically manufacture, import, or process chemical substances listed 
on the TSCA Chemical Substance Inventory in the future. The following 
list of North American Industrial Classification System (NAICS) codes 
are not intended to be exhaustive, but rather provides a guide to help 
readers determine whether this action may apply to them:
     Chemical manufacturing or processing (NAICS code 325).
     Petroleum and Coal Products Manufacturing (NAICS code 
324).

In addition, the discussion in Unit III.A. describes in more detail 
which chemical substances would and would not be subject to reporting 
under this proposed action. You may also consult 40 CFR 710.3 and 
710.4, as well as the proposed regulatory text in this document, for 
further information on the applicability of exemptions to this proposed 
rule. If you have any questions regarding the applicability of this 
action to a particular entity, consult the technical person listed 
under FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    EPA is proposing this rule under TSCA section 8(b), 15 U.S.C. 
2607(b). As described in more detail in Unit II.A., TSCA was amended by 
the Frank R. Lautenberg Chemical Safety for the 21st Century Act, 
Public Law 114-182. The Government Paperwork Elimination Act (GPEA), 44 
U.S.C. 3504, provides that, when practicable, Federal organizations use 
electronic forms, electronic filings, and electronic signatures to 
conduct official business with the public.
    Note that TSCA's statutory definition of ``manufacture'' includes 
importing. Accordingly, the regulatory definition of ``manufacture'' 
for this rule includes importation. All references to manufacturing in 
this notice should be understood to also encompass importing. Where 
EPA's intent is to specifically refer to domestic manufacturing or 
importing (both activities constitute ``manufacture''), this notice 
will do so expressly.

C. What action is the Agency taking?

    Pursuant to TSCA section 8(b)(4)(A), EPA is proposing procedural, 
retrospective notification requirements for persons who manufactured 
chemical substances on the TSCA Inventory as described in Unit III.A. 
Persons who manufactured these chemical substances for nonexempt 
commercial purposes during the ten-year time period ending on June 21, 
2016, would be required to notify the Agency of certain information 
described in Unit III.C., including chemical identity and the date 
range when manufacture occurred in that ten-year time period. EPA would 
use the chemical identity information obtained from this retrospective 
reporting to designate as active those chemical substances on the TSCA 
Inventory for which notices were received. If no notice is received 
during this retrospective reporting for a chemical substance subject to 
designation on the TSCA Inventory, then that substance would be 
designated as inactive. EPA would require date range information in 
order to obtain confirmation that the chemical substance in question 
had indeed been manufactured or processed between June 21, 2006 and 
June 21, 2016.
    Pursuant to TSCA section 8(b)(5)(B), EPA is also proposing 
procedural, forward-looking notification requirements for persons who 
intend to manufacture or process inactive chemical substances on the 
TSCA Inventory. After EPA's first publication of the TSCA Inventory 
that includes active and inactive designations determined by the 
retrospective reporting, persons who intend to manufacture or process 
for nonexempt commercial purposes those chemical substances designated 
as inactive on the TSCA Inventory would be required to notify the 
Agency of certain information described in Unit III.C. Such 
notification must occur before the actual date of manufacturing or 
processing. EPA is proposing that notification, which shall include 
chemical identity and the actual date of manufacturing or processing, 
occur no more than 30 days before the actual date of manufacturing or 
processing.
    Included in this proposed rule are electronic reporting 
requirements described in Unit III.D. that are similar to those 
established in 2013 for reporting other kinds of information to EPA 
under TSCA sections 4, 5, 8(a), and 8(d). See 78 FR 72818, December 4, 
2013 (FRL 9394-6). The Agency is proposing to require submitters to use 
EPA's Central Data Exchange (CDX), the Agency's electronic reporting 
portal, for reporting information under this proposed rule. The 
information would be submitted to the Agency under TSCA section 8(b), 
but the practical rationales for requiring submissions to proceed 
through CDX, cited in 2013, are also pertinent here by analogy.
    Also included in this proposal are amendments to 40 CFR part 710, 
which conform the definitions applicable to these reporting 
requirements with those that apply to Chemical Data Reporting rule 
requirements (definitions found at 40 CFR 704.3 and 711.3) and the 
submission of Premanufacture Notifications (definitions found at 40 CFR 
720.3). EPA believes that basing Section 8(b) reporting on definitions 
that are already familiar to the public from CDR and PMN reporting 
would reduce the potential for confusion and reduce the burden of rule 
familiarization. EPA is not proposing to modify the 40 CFR part 710 
definitions in any manner that either is not conforming to Part 704, 
710, or 720, or is a purely technical correction (e.g., eliminating 
references to the Canal Zone from the definition of ``State''). Any 
other changes to the definitions in 40 CFR part 710 are beyond the 
scope of this proposal.
    Included in this proposed rule are procedures for persons who co-
manufacture or co-process a reportable chemical substance. These 
procedures would allow the submission of a single commercial activity 
notification in single instances of co-manufacturing or co-processing 
of a particular volume of a chemical substance. These proposed 
procedures are similar to Chemical Data Reporting rule requirements (40 
CFR 711.22) when two or more persons are involved in a particular 
manufacture or import transaction. EPA believes that allowing a single 
notification for co-manufacturers and co-processors would serve to 
provide the Agency with the information necessary to designate a 
chemical substance as active on the TSCA Inventory while reducing 
duplicative reporting.
    Also included in this proposed rule are requirements for filing a 
joint submission when specific chemical identity information is claimed 
confidential by a supplier. If an importer cannot provide the specific 
chemical identity of a reportable substance to EPA because the 
information is claimed confidential by a supplier, and therefore is 
unknown to the importer, the importer would be required to ask the 
supplier to provide the confidential chemical identity information 
directly to the Agency in a joint submission. If a domestic 
manufacturer or processor cannot provide the specific chemical identity 
of a reportable substance to EPA because the chemical identity of a 
reactant is claimed confidential by a supplier, and therefore is 
unknown to the domestic manufacturer or processor, the manufacturer or 
processor would be required to ask the supplier to provide the 
confidential chemical identity information directly to the Agency in a 
joint submission. EPA would only accept joint submissions that are 
submitted electronically using CDX.

[[Page 4257]]

This requirement is similar to Chemical Data Reporting rule 
requirements (40 CFR 711.15) and would allow EPA to obtain the 
information necessary to identify the specific chemical identity of a 
reportable substance and designate it as active on the TSCA Inventory.

D. Why is the Agency taking this action?

    TSCA section 8(b)(4)(A) requires EPA to issue a final retrospective 
reporting rule by June 22, 2017. These proposed reporting requirements 
would enable EPA to fulfill a statutory obligation to designate 
chemical substances on the TSCA Inventory as active or inactive in U.S. 
commerce. This proposed rule is not intended to indicate conclusions 
about the risks of chemical substances on the TSCA Inventory. 
Nonetheless, the designation of a chemical substance as active or 
inactive would be relevant to the Agency's prioritization of chemical 
substances in U.S. commerce under TSCA section 6(b).
    Furthermore, TSCA section 8(b)(5) establishes a forward-looking 
notification requirement that goes into effect as soon as EPA 
designates inactive substances. EPA is proposing to establish the 
procedural framework whereby manufacturers and processors would 
discharge their notice obligations under this section of TSCA.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs of establishing the proposed 
reporting requirements for manufacturers and processors. This analysis, 
which is available in the docket, is discussed in Unit VI. and is 
briefly summarized here (Ref. 1).
    During the retrospective (or ``start-up'') period, between 
approximately June 2017 and June 2018, typical costs per firm are 
estimated at $1,346 per submission (with an estimated seven chemicals 
per submission), with possible additional costs at $40.22 per CDX 
registration in the event that the submitter is not currently 
registered in CDX. Among manufacturers, an estimated 6,169 firms would 
undertake rule familiarization with 4,692 completing compliance 
determination, form completion, and recordkeeping. For manufacturers, 
the total burden during start-up is estimated at 86,783 hours with an 
associated total cost of $6.68 million. For processors, the estimate of 
the universe of potentially affected firms is 161,550 who might 
initiate rule familiarization. For processors initiating rule 
familiarization, the cost would be 4 hours per firm (about $300 per 
firm). EPA believes that it is unlikely that 100% of processors will 
initiate rule familiarization and that the percentage will be less. EPA 
estimates that only 100 processors will complete compliance 
determination, form completion, and recordkeeping. For the 100 
processors who complete a submission with one chemical, the burden 
during start-up is estimated at 692 hours with an associated cost of 
$0.05 million. Lastly, for 469 new CDX registrations (for individuals 
lacking previous experience with electronic reporting to EPA), burden 
during start-up is estimated at 249 hours with an associated cost of 
$0.02 million.
    The rule has minimal burden and cost implications related to 
ongoing reporting after the start-up year. The forward-looking (or 
``Ongoing'') reporting after June 2018 involves compliance 
determination, form completion, and recordkeeping for twenty 
manufacturers and/or processors per year. Burden and cost are estimated 
to total 142 burden hours per year with an associated cost of $10,790 
per year.
    Agency activities due to the rule include CDX and Chemical 
Information Submission System (CISS) capacity expansions, time to 
manage commercial activity notices, and increased costs incurred when 
making revisions to the TSCA Inventory. Associated costs are estimated 
at $3.84 million during start-up, and $0.20 million annually 
thereafter.
    Combining Industry and Agency cost estimates, and annualizing over 
a 10-year period, the total cost of the rule is estimated at $7.22 
million per year using a 3% discount rate, and at $8.77 million per 
year using a 7% discount rate.

F. 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 CD-ROM 
or other electronic media that you mail to EPA, mark the outside of the 
media as CBI and then identify electronically within the media 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 would 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. Overview of Applicable Authority

    EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to 
compile and keep current a list of chemical substances manufactured or 
processed in the United States. In 1977, EPA promulgated a rule under 
TSCA section 8(a), 15 U.S.C. 2607(a), to provide the information 
necessary for EPA to compile a list of chemical substances that had 
been in commerce since January of 1975 (Ref. 2). This list is known as 
the TSCA Chemical Substance Inventory (or simply the ``TSCA 
Inventory''). Since compiling the initial TSCA Inventory, EPA regularly 
adds new chemical substances that have completed new chemical review 
requirements pursuant to TSCA section 5(a), 15 U.S.C. 2604(a), and that 
have been manufactured or processed for nonexempt commercial purposes. 
EPA maintains the TSCA Inventory as the authoritative list of all the 
chemical substances reported to the Agency for inclusion on the TSCA 
Inventory.
    1. Retrospective reporting under TSCA section 8(b)(4)(A). TSCA 
section 8(b)(4)(A) requires EPA to promulgate a rule that requires 
manufacturers to notify the Agency, by not later than 180 days after 
the date on which the final rule is published in the Federal Register, 
of each chemical substance on the TSCA Inventory that was manufactured 
for nonexempt commercial purpose during the 10-year period ending on 
June 21, 2016. If EPA receives a valid notice for a chemical substance 
on the TSCA Inventory, EPA must designate that chemical substance as an 
active substance. If EPA receives no valid notice for a chemical 
substance on the TSCA Inventory (and that is subject to designation), 
EPA must designate that chemical substance as an inactive substance.
    2. Forward-looking reporting under TSCA section 8(b)(5)(B). TSCA 
section 8(b)(5)(B) requires persons who intend to manufacture or 
process chemical substances for nonexempt commercial purposes in the 
future that are designated on the TSCA Inventory as inactive to notify 
EPA prior to the date that these chemicals are to be manufactured or 
processed. Upon receiving a valid notice, EPA must change the 
designation of the chemical substance from inactive to active.
    3. Processors. TSCA section 8(b)(4)(A) indicates that the 
Administrator may require processors to report similarly to

[[Page 4258]]

manufacturers under the rule. This proposed rule would not require 
processors to report during the retrospective reporting period. 
However, once EPA has designated a chemical substance as an inactive 
substance, the processing of that chemical substance for a non-exempt 
commercial purpose would be unlawful, unless the processor first 
submits a notice as required by TSCA section 8(b)(5)(B). Therefore, 
this proposed rule would allow processors to report during the 
retrospective reporting period, extended to not later than 360 days 
after the date on which the final rule is published in the Federal 
Register (which will be 180 days after EPA's publication of the first 
version of the TSCA Inventory with preliminary commercial activity 
designations). Processors could report any chemical substance that they 
had processed for a nonexempt commercial purpose during the 10-year 
period ending on June 21, 2016. The extended submission period for 
processors would allow processors time to evaluate whether they wish to 
voluntarily report chemical substances that have not been reported by 
manufacturers or importers and that are preliminarily designated as 
inactive on EPA's publication of the first version of the revised TSCA 
Inventory. (These designations would be merely preliminary so there 
would not yet be an obligation to report under TSCA Section 
8(b)(5)(B).) If EPA receives no notice on a chemical substance that is 
subject to designation, EPA then must designate that preliminarily 
inactive substance as actually inactive. Hence, persons who processed a 
chemical substance between June 2006 and June 2016 may wish to report 
under TSCA section 8(b)(4)(A) in order to avoid a subsequent obligation 
to curtail processing on the day that EPA designates the substance as 
inactive, under TSCA section 8(b)(5)(B). Processing could resume as 
soon as the notice under TSCA section 8(b)(5)(B) is submitted, but 
processors may nonetheless find it less disruptive to ensure that the 
chemical substance is earlier reported as active under TSCA section 
8(b)(5)(A).
    4. General provisions. General provisions for TSCA section 8(b) 
rules appear in 40 CFR part 710. These provisions include definitions 
that apply to reporting under this proposed rule and also describe the 
scope of the Inventory. For example, 40 CFR 710.1 describes 
requirements for EPA to compile and keep current the TSCA Inventory of 
chemical substances manufactured or processed for commercial purposes, 
including the periodic updates to the Inventory to include new chemical 
substances reported under TSCA section 5(a) and commercialized for 
nonexempt purposes. In addition, the definitions in TSCA section 3 
apply to this rulemaking.
    5. Electronic reporting under the Government Paperwork Elimination 
Act (GPEA). GPEA, 44 U.S.C. 3504, provides that, when practicable, 
Federal organizations should use electronic forms, electronic filings, 
and electronic signatures to conduct official business with the public. 
EPA's Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR 
part 3), provides that any requirement in title 40 of the CFR to submit 
a notice directly to the Agency can be satisfied with an electronic 
submission that meets certain conditions once the Agency published a 
document in the Federal Register announcing that EPA is prepared to 
receive certain documents in electronic form (Ref. 3). For more 
information about CROMERR, go to https://www.epa.gov/cromerr.

III. Summary of Proposed Rule

    EPA is proposing reporting and procedural requirements for 
manufacturers and processors of chemical substances pursuant to TSCA 
section 8(b).

A. What chemical substances would be reportable under this rule?

    1. Reportable chemical substances. As a general matter, the 
retrospective reporting requirement of this proposed rule would apply 
to chemical substances listed on the TSCA Inventory that were 
manufactured for a nonexempt commercial purposes during the 10-year 
period ending on June 21, 2016. This lookback period is set by statute. 
TSCA also establishes forward-looking reporting requirements, at 
section 8(b)(5)(B), with respect to chemical substances listed on the 
TSCA Inventory that EPA designates as inactive. The TSCA Inventory is 
available at https://www.epa.gov/tsca-inventory.
    2. Exemptions from reporting. i. Statutory background. This 
proposed rule provides exemptions from reporting based on sections 
8(b)(4) and (5) and the general objectives that EPA can infer from that 
text. Unlike the reporting that informed the initial compilation of the 
TSCA Inventory (which arose under TSCA section 8(a)), the reporting 
requirements described in this proposed rule arise directly under TSCA 
section 8(b). EPA must finalize the retrospective reporting 
requirements by June 22, 2017, and all mandatory reporting under TSCA 
section 8(b)(4) must be completed by not later than 180 days 
thereafter. TSCA section 8(b)(4) and 8(b)(5) reporting requirements 
apply to ``each chemical substance,'' found on the TSCA Inventory, 
subject to the provision that reporting obligations shall only be 
triggered by manufacturing or processing for a ``nonexempt commercial 
purpose.'' The retrospective reporting requirements under TSCA section 
8(b)(4) are expressed as being ``subject to the limitations'' of TSCA 
section 8(a)(5)(A). TSCA section 8(a)(5)(A), in turn, specifies that 
``to the extent feasible,'' EPA shall: (1) Avoid requiring reporting 
that is ``unnecessary or duplicative;'' (2) ``minimize the cost of 
compliance'' to small manufacturers and processors; and (3) apply 
reporting obligations to the persons likely to have information 
relevant for effective implementation.
    Furthermore, as EPA interprets its statutory authority, the 
reporting is intended to support two key objectives. First, to enable 
EPA to determine which reportable chemical substances are active in 
U.S. commerce. EPA will accomplish this based on notices received. 
Reportable chemical substances for which no notices are received would 
be considered inactive in U.S. commerce. See TSCA section 
8(b)(4)(A)(iii). Second, with respect to chemical substances identified 
as being active in commerce that are listed on the confidential portion 
of the TSCA Inventory, to require that persons manufacturing or 
processing such chemical substances request that existing claims for 
protection against disclosure of the specific chemical identity be 
maintained. See TSCA sections 8(b)(4)(B)(ii), 8(b)(4)(C), 8(b)(5).
    ii. Excluded chemical substances. If a chemical substance is not 
listed on the TSCA Inventory, then by the terms of TSCA sections 
8(b)(4) and (5), it is not subject to reporting under this proposed 
rule. For example, chemical substances that are manufactured under a 
TSCA section 5(h) exemption are not added to the TSCA Inventory. 
Accordingly, this proposed rule would not require that reporting occur 
with respect to such substances. This is reflected in the proposed 
definitions at 40 CFR 710.23, which are drafted in such a manner that 
if a chemical substance was not on the TSCA Inventory as of June 22, 
2016, it would not be subject to reporting.
    Naturally occurring chemical substances also are proposed to be 
excluded from reporting under this proposed rule, so long as the 
manufacturing and processing of such substances meets the criteria set 
forth in 40 CFR 710.27(b). When EPA required

[[Page 4259]]

manufacturers and processors to submit notices in support of the 
original compilation of the TSCA Inventory in 1977, EPA made clear that 
reporting on naturally occurring chemical substances would not be 
necessary, as these substances would automatically be included in the 
Inventory as a category: ``Naturally Occurring Chemical Substances,'' 
42 FR 64578 (1977). EPA proposes to simply designate the whole category 
of Naturally Occurring Chemical Substances as active substances, by 
rule, without the need for reporting to differentiate among such 
substances.
    Finally, this proposed rule would not require manufacturers to 
report chemical substances that are on both the non-confidential 
portion of the TSCA Inventory and the interim list of active substances 
described in TSCA section 8(b)(6). Such reporting would be unnecessary, 
since EPA already has reporting data to establish that the chemical 
substance was in active commerce at some time between June 21, 2006 and 
June 21, 2016. Furthermore, for such substances, there are no existing 
claims for protection against disclosure of the specific identity of 
the chemical substance for any party to elect to maintain or not 
maintain. With respect to chemical substances on the confidential 
portion of the TSCA Inventory, however, such reporting still serves a 
statutory function under TSCA sections 8(b)(4)(B)(ii) and 8(b)(4)(C), 
even where there is already adequate evidence, prior to reporting, that 
the substance was in active commerce during the lookback period.
    Regarding the composition of the interim list of active substances, 
TSCA section 8(b)(6) requires EPA to compile an interim list of active 
substances reported under 40 CFR part 711 for the purposes of TSCA 
section 6(b), before promulgation of the rule. The definition of the 
interim list is somewhat ambiguous, since it refers to the ``reporting 
period that most closely preceded June 22, 2016.'' The term ``reporting 
period'' is not defined under 40 CFR part 711. In light of the 
definitional ambiguity of TSCA section 8(b)(6) and EPA's weighing of 
the statutory objectives noted previously, EPA has construed the 
``interim list of active substances'' to include 2012 CDR data, which 
avoids delay of this proposed rule, but would allow for the 2016 CDR 
data to give rise to a reporting exemption as soon as they are publicly 
released in final form. Under the proposal, manufacturers and 
processors of chemical substances on the non-confidential portion of 
the Inventory would be exempt from reporting if the manufacture of that 
chemical substance was already reported (by any party) in response to 
2012 or 2016 CDR.
    iii. Manufacturing or processing for an exempt commercial purpose. 
TSCA section 8(b) directs EPA to limit reporting obligations to 
manufacturing and processing for ``nonexempt commercial purpose.'' This 
phrase had a commonly-accepted usage at the time that TSCA was amended, 
in 2016. See, for example, ``Certain New Chemicals; Receipt and Status 
Information'' (referencing TSCA section 5 requirements as applying to 
manufacture for ``nonexempt commercial purpose'') (Ref. 4), and ``2016 
Chemical Data Reporting Frequent Questions'' (associating ``nonexempt 
commercial purpose'' with exemptions codified at 40 CFR 720.30 and 40 
CFR 711.10(a)) (Ref. 5). Since reporting under TSCA section 8(b) is a 
form of existing chemical reporting, EPA construes the phrase 
``nonexempt commercial purpose'' consistent with the manner in which 
the 40 CFR 720.30 exemptions from pre-manufacture reporting 
requirements were adapted for use in the CDR at 40 CFR 711.10. Thus, 
for example, the manufacturing or processing of chemical substances 
solely in small quantities for research and development would not 
trigger reporting obligations under this proposed rule. Similarly, the 
manufacturing or processing of impurities, or byproducts that have no 
subsequent commercial purpose, would not trigger reporting obligations 
under this proposed rule. Finally, since the CDR integrates reporting 
exemptions for persons who import chemical substances solely as part of 
articles with reporting exemptions for nonexempt commercial purposes 
(see 40 CFR 711.10), EPA construes the TSCA 8(b) reference to 
``nonexempt commercial purpose'' as also encompassing this article 
exemption. Further supporting this interpretation, EPA believes it 
would be incongruous to establish a more comprehensive reporting 
obligation for the import of inactive existing chemical substances 
under TSCA section 8(b)(5) (i.e., including import as part of an 
article), than would be applicable to the import of new chemical 
substances under TSCA section 5 (i.e., excluding import as part of an 
article).
    3. Chemical substances added to the Inventory on or after June 22, 
2016. In this proposed rule, chemical substances added to the Inventory 
on or after June 22, 2016 would be designated as active, without the 
need for any reporting to establish that the chemical substance is 
active and without the need for any statement by manufacturers or 
processors indicating whether such persons wish to maintain an existing 
claim for protection against disclosure of the specific chemical 
identity of the chemical substance. Reporting under TSCA section 
8(b)(4) is based on manufacturing or processing, for non-exempt 
commercial purposes, that occurred between June 21, 2006 and June 21, 
2016. TSCA section 8(b)(4)(A)(iii) directs EPA to classify a chemical 
substance as inactive if no notice of manufacturing or processing is 
received by EPA. A substance added to the Inventory on or after June 
22, 2016, however, would be added so recently that it has no 
manufacturing or processing overlapping with the lookback period. It 
would be illogical to designate a very recent addition to the Inventory 
as inactive, on the grounds that the chemical substance was too 
recently added to the Inventory to be captured in the retrospective 
reporting of current manufacturing and processing. Furthermore, if a 
chemical substance was added to the Inventory on or after June 22, 
2016, then any claim for the protection against disclosure of the 
specific chemical identity of such a substance would be a new claim 
rather than the maintenance of an existing claim for protection of the 
information. For the reasons presented previously, EPA construes TSCA 
section 8(b)(4) reporting requirements to be limited to chemical 
substances that were added to the Inventory prior to June 22, 2016.

B. When would reporting be required?

    1. Retrospective reporting period for manufacturers. This proposed 
rule would require manufacturers to report to the Agency not later than 
180 days after the final rule is published in the Federal Register. The 
180-day time period for this retrospective reporting for manufacturers 
is the maximum time allowed under TSCA section 8(b)(4)(A). Following 
this retrospective reporting for manufacturers, EPA would include the 
active and inactive designations, determined by the notices received, 
on the TSCA Inventory.
    2. Retrospective reporting period for processors. This proposed 
rule would allow processors to report to the Agency not later than 360 
days after the final rule is published in the Federal Register. The 
360-day time period for this retrospective reporting for processors 
would allow processors to search EPA's publication of a first draft of 
the TSCA Inventory with active designations and draft inactive 
designations, based on retrospective reporting by manufacturers, and to 
report only those chemical substances

[[Page 4260]]

not already reported. This first draft of the TSCA Inventory with 
active designations and draft inactive designations would not have the 
legal effect of actually designating any chemical substance as 
inactive. Processors would have the option to simply not report under 
TSCA section 8(b)(4) and continue processing until such time when EPA 
has actually designated a chemical substance as inactive. At such time, 
any further processing of the chemical substance, without prior 
notification to EPA, would be prohibited by section 8(b)(5). Prior 
notification would allow EPA to add the chemical substance to the TSCA 
Inventory as an active substance.
    3. Forward-looking reporting. After EPA completes its review of the 
notices submitted under TSCA section 8(b)(4)(A), it must designate as 
inactive any chemical substance (subject to designation) for which no 
notice was received. TSCA section 8(b)(5)(B) provides that, once a 
chemical substance has been designated as inactive, any person who 
intends to manufacture or process that inactive substance for a 
nonexempt commercial purpose must first notify the Agency before the 
date on which the inactive substance is manufactured or processed. EPA 
proposes to furthermore limit the submission period for such notices, 
so that they may not be submitted more than 30 days before the actual 
date of manufacturing or processing.
    The 30-day time period for forward-looking reporting is based on 
EPA's experience with Premanufacture Notices (PMNs). Although persons 
often form the intent to commercially manufacture or process chemical 
substances several months ahead of time, EPA's experience with 
processing PMNs is that business decisions, technical difficulties, and 
other unforeseen circumstances may delay a company's plans to 
commercialize. EPA believes that a commercial activity notice reflects 
a more tentative or provisional intent to manufacture or process if it 
is submitted more than 30 days prior to the actual date of 
manufacturing or processing of the chemical substance. As such, it is 
less reliable as evidence that placement as active Inventory is 
warranted. Reassigning chemical substances from inactive to active 
status, based on relatively unreliable indicia of intent to 
manufacture, could affect the reliability of the Inventory 
designations. Therefore, this proposed rule would require that forward-
looking reporting of chemical substances designated as inactive on the 
TSCA Inventory occur not earlier than 30 days before companies intend 
to manufacturing or processing for nonexempt commercial purposes.

C. What information would be reported?

    1. Retrospective reporting period for manufacturers. This proposed 
rule would require that manufacturers reporting for the retrospective 
reporting period provide certain information including chemical 
identity, type of commercial activity (i.e., whether it is domestic 
manufacture and/or import), date range of manufacture for nonexempt 
commercial purpose during the 10-year reporting period ending on June 
21, 2016, and whether they seek to maintain an existing claim for 
protection against disclosure of a confidential chemical identity, if 
applicable.
    2. Retrospective reporting period for processors. This proposed 
rule would allow processors to report for the retrospective reporting 
period, provided that the processor reports timely and consistent with 
the pertinent reporting requirements, including providing certain 
information such as chemical identity, date range of processing for 
nonexempt commercial purpose during the 10-year reporting period ending 
on June 21, 2016, and whether they seek to maintain an existing claim 
for protection against disclosure of a confidential chemical identity, 
if applicable.
    3. Forward-looking reporting. TSCA section 8(b)(5) requires that 
manufacturers and processors of inactive substances notify EPA before 
the date on which they manufacture or process an inactive substance for 
non-exempt commercial purposes. This proposed rule stipulates that they 
would do so in the following manner: By reporting certain information 
including chemical identity, type of commercial activity (i.e., whether 
it is domestic manufacture, import, and/or processing), actual date of 
manufacturing or processing for nonexempt commercial purpose, and 
whether they seek to maintain an existing claim for protection against 
disclosure of a confidential chemical identity, if applicable.
    4. Reporting forms. EPA developed two versions of a Notice of 
Activity (NOA) reporting form for submitting the information described 
in this proposed rule for the two reporting scenarios, retrospective 
and forward-looking (Ref. 6). NOA Form A (EPA Form No. TBD-1) would be 
used by manufacturers for the retrospective reporting period. It would 
also be used by processors who report for the retrospective reporting 
period. NOA Form B (EPA Form No. TBD-2) would be used by manufacturers 
and processors for forward-looking reporting. The new NOA forms are 
based on EPA's Notice of Commencement (NOC) form (Ref. 7), since much 
of the information submitted in an NOC form is the same or similar to 
the information proposed in the NOA.
    Any person required to report under this proposed rule would 
provide the information identified in the relevant version of the NOA 
forms to the extent it is known to or reasonably ascertainable by them. 
Drafts of the two versions of the proposed NOA reporting forms are 
available in the docket for public review (Ref. 6).
    As noted previously, these forms require very basic explanatory 
information about the type of commercial activity at issue (domestic 
manufacture, import, or processing) as well as the date range over 
which the activity occurred or the date when the activity is intended 
to resume. The collection of this explanatory information is intended 
to reduce the likelihood of receiving erroneous notices (e.g., notices 
regarding commercial activity outside the lookback period), to support 
EPA's capacity to inquire into the accuracy of activity notices, and 
thus to increase the reliability of commercial activity designations on 
the TSCA Inventory.

D. How would information be submitted to EPA?

    In 2013, EPA finalized a rule to require electronic reporting of 
certain information submitted to the Agency under TSCA sections 4, 5, 
8(a) and 8(d) (Ref. 8). The final rule followed two previous rules 
requiring similar electronic reporting of information submitted to the 
Agency for TSCA Chemical Data Reporting and Pre-Manufacture 
Notifications. This proposed rule would require electronic reporting 
similar to the requirements established in 2013 for submitting certain 
other information under TSCA (see 711.35 and 720.40). This proposed 
rule would require submitters to use EPA's CDX, the Agency's electronic 
reporting portal, and EPA's Chemical Information Submission System 
(CISS), a web-based reporting tool, for all reporting under this 
proposed rule in accordance with section 3.2000 of 40 CFR part 3 
(CROMERR) (Ref. 3).
    This proposed rule would require persons submitting notices of 
activity to EPA under TSCA section 8(b) to follow these same electronic 
reporting procedures used for other TSCA submissions, i.e., to register 
with EPA's CDX and use CISS to prepare a data file for submission. 
Registration in CDX

[[Page 4261]]

enables CDX to authenticate identity and verify authorization. To 
register, the CDX registrant (also referred to as ``Electronic 
Signature Holder'' or ``Public/Private Key Holder'') agrees to the 
Terms and Conditions, provides information about the submitter and 
organization, and selects a user name and password. Users who have 
previously registered with CDX for other submissions would be able to 
add the ``Submission for Chemical Safety and Pesticide Program'' 
service to their current registration in CDX and use the CISS web-based 
reporting tool.
    EPA developed the Chemical Information Submission System (CISS) for 
use in submitting data electronically under TSCA sections 4, 5, 8(a), 
and 8(d) to the Agency. The tool is available for use with Windows, 
Macs, Linux, and UNIX based computers and uses ``Extensible Markup 
Language'' (XML) specifications for efficient data transmission across 
the Internet. CISS works with CDX to secure online communication and 
provides user-friendly navigation. The NOA forms described in this 
proposed rule will be included in an e-NOA software module in CISS. 
Once a user completes entry of the relevant data fields and metadata 
information in the appropriate NOA form, the CISS reporting tool 
validates the submission by performing a basic error check. CISS also 
allows the user to choose ``Preview,'' ``Save,'' or ``Submit.'' When 
``Submit'' is selected, the user is asked to provide the user name and 
password that was created during the CDX registration process. CISS 
then submits the data via CDX. Upon successful receipt of the 
submission by EPA, the status of the submissions will be flagged as 
``Submitted.'' The user can also login to the application and download 
their Copy of Record.
    EPA believes that electronic reporting reduces the reporting burden 
for submitters by reducing the cost and time required to review, edit, 
and transmit data to the Agency. It also allows submitters to share a 
draft submission within their organization and more easily save a copy 
for their records or future use. The resource and time requirements to 
review, process, store, and retrieve data by the Agency would also be 
reduced.
    Any person submitting a reporting form could claim any part or all 
of the form as confidential. Except as otherwise provided in this 
proposed rule, any information that is claimed as confidential would be 
disclosed by EPA only to the extent and by the means of the procedures 
set forth in 40 CFR part 2.

E. How would CBI claims and requests be handled?

    Notices pursuant to this rulemaking may contain two different types 
of CBI assertions: Claims for protection of information other than 
specific chemical identify, and requests to maintain existing claims 
for protection of specific chemical identify.
    1. Information other than specific chemical identity. For all new 
claims for protection (i.e., for all CBI assertions under this rule 
other than requests to maintain existing claims for protection of 
specific chemical identity), TSCA section 14(c)(1)(B) and 14(c)(5) 
require that persons claiming CBI must provide a specific, 
certification statement regarding the basis for the CBI claims. In 
addition, this proposed rule would require that all such claims be 
substantiated at the time of submission, except for claims for 
information exempted from substantiation under section 14(c)(2). In 
view of the rapid EPA review of claims required by section 14(g)(1), 
and in order to reduce the likelihood of unwarranted claims, EPA 
believes that a concurrent substantiation is required. EPA will review 
a representative subset of these claims as specified by section 
14(g)(1).
    2. Requests to maintain existing CBI claims for chemical identity. 
Requests to maintain existing CBI claims for specific chemical identity 
on Form A are governed in part by TSCA sections 8(b)(4)(C-E). TSCA 
section 8(b)(4)(C), in particular, requires EPA to issue a rule to 
establish a review plan for these requests. That review plan must 
specify a time when the Form A CBI requests for specific chemical 
identity are to be substantiated. EPA will be conducting a separate 
rulemaking to establish this review plan. Therefore, this proposal does 
not include mandatory substantiation requirements for Form A CBI 
requests for chemical identity. Mandatory substantiation requirements 
will be part of the review plan promulgated under section 8(b)(4)(C). 
However, the Agency proposes to allow companies to submit early 
substantiation at the same time that their Form A is filed, if they so 
choose. As long as the period between the date these earlier 
substantiations are received and the due date to be established in the 
review plan (yet to be proposed) is not more than five years, these 
early substantiations would exempt the company from the requirement to 
submit additional substantiation for their Form A under the terms of 
the review plan. See section 8(b)(4)(D)(i). EPA will review requests to 
maintain CBI claims for specific chemical identity in accordance with 
the 8(b)(4)(D) review plan in the timeframe mandated by section 
8(b)(4)(E).
    Any manufacturer or processor submitting an active chemical 
notification under TSCA section 8(b)(4)(A) may seek to maintain an 
existing CBI claim for specific chemical identity, regardless of 
whether that person asserted the original claim that caused the 
specific chemical identity to be treated as confidential. EPA believes 
this is the correct interpretation of ``a manufacturer or processor . . 
. that seeks to maintain an existing claim for protection of against 
disclosure'' of specific chemical identity. A number of manufacturers 
and processors may legitimately benefit from the confidential status of 
a specific chemical identity, and the initial claimant may no longer 
exist. EPA does not believe that Congress intended for specific 
confidential chemical identities to be disclosed without providing the 
opportunity for manufacturers and processors to make a request that the 
identities should remain confidential simply because the original 
claimants no longer manufacture the chemical substances.
    Pursuant to TSCA section 8(b)(4)(B)(iv), EPA would move an active 
chemical substance from the confidential portion of the Inventory to 
the non-confidential portion if no manufacturer or processor submitting 
an active chemical notification under TSCA section 8(b)(4)(A) requests 
to maintain the existing CBI claim for the specific identity of that 
chemical substance. See proposed 710.37(a).
    Requests to maintain existing CBI claims for specific chemical 
identity on Form B are governed by TSCA section 8(b)(5)(B), which 
provides that the request to maintain the claim must be substantiated 
not later than 30 days after submitting Form B. See section 
8(b)(5)(B)(ii)(II). Proposed substantiation requirements for Form B CBI 
claims for chemical identity are found in section 710.37(a)(1)(ii).
    Although TSCA section 8(b)(5) provides that substantiation for 
requests to maintain existing CBI claims for specific chemical identity 
must be provided not later than 30 days after submitting a Form B, 
persons submitting a Form B may find it more efficient to simply 
provide the substantiation for a CBI claim for specific chemical 
identity at the time of filing. Section 8(b)(5)(iii)(II) provides that 
the Agency shall ``promptly'' review CBI claims for specific chemical 
identity in Form B. The Agency intends to review these claims within 90 
days of receipt of the substantiation.

[[Page 4262]]

IV. Request for Comments

    EPA is seeking public comment on all aspects of this proposed rule, 
including specific issues throughout this document, as well as other 
issues discussed in this Unit.

A. Considerations for the Agency's Economic Impact Analysis

    EPA has evaluated the potential costs for manufacturers and 
processors of chemical substances reportable under this proposed rule 
(Ref. 1). EPA is specifically seeking additional information and data 
that the Agency could consider in developing the final economic 
analysis. In particular, EPA is seeking data that could facilitate the 
Agency's further evaluation of the potentially affected industry and 
firms, including data related to potential impacts for those small 
businesses that would be subject to reporting.

B. Electronic Reporting

    Requiring electronic reporting under this proposed rule that is 
similar to those established in 2013 for other TSCA reporting, EPA 
expects to save time, improve data quality, and provide efficiencies 
for both submitters and the Agency. EPA is specifically interested in 
comments related to the adoption of the existing mechanisms and 
procedures for use in transmitting the notices proposed in this rule, 
including comments related to the extent to which potential reporting 
entities are already familiar with these mechanisms and procedures 
because of their existing use for other TSCA reporting. EPA is also 
interested in feedback on how electronic reporting affects potential 
reporting entities in terms of reporting time, reporting efficiency, 
and potential burden associated with training to use the electronic 
systems (i.e., CDX and CISS).

V. References

    The following is a listing of the documents that are specifically 
referenced in this proposed rule. The docket includes these references 
and other information considered by EPA. For assistance in locating 
these other documents, please consult the technical contact listed 
under FOR FURTHER INFORMATION CONTACT.

1. 2016. EPA. Burden and Cost Report for the Proposed Rule: TSCA 
Inventory Notification Requirements (RIN 2070-AK24, December 21, 
2016).
2. 1977. EPA. Inventory Reporting Requirements; Final Rule. Federal 
Register (42 FR 64572, December 23, 1977) (FRL 817-1).
3. 2005. EPA. Cross-Media Electronic Reporting Rule (CROMERR); Final 
Rule. Federal Register (70 FR 59848, October 13, 2005) (FRL 7977-1).
4. 2010. EPA. Certain New Chemicals; Receipt and Status Information; 
Notice. Federal Register (75 FR 71688, November 24, 2010) (FRL 8852-
1).
5. 2016. EPA. 2016 Chemical Data Reporting Frequent Questions. 
https://www.epa.gov/chemical-data-reporting/2016-chemical-data-reporting-frequent-questions.
6. 2016. EPA. Notice of Activity Form A and Form B; Draft.
7. 2009. EPA. Notice of Commencement Form; Final.
8. 2013. EPA. Electronic Reporting Under the Toxic Substances 
Control Act; Final Rule. Federal Register (78 FR 72818, December 4, 
2013) (FRL 9394-6).
9. 2016. EPA. Information Collection Request for the TSCA section 
8(b) Proposed Reporting Requirements for TSCA Inventory Notification 
Active-Inactive (EPA ICR No. 2517.01).
10. 2016. EPA. Small Entity Analysis Report for the Proposed Rule: 
TSCA Inventory Notification Requirements (December 16, 2016).

VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action that was 
submitted to the Office of Management and Budget (OMB) for review under 
Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 
3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    The information collection activities associated with this proposed 
rule have been submitted to OMB for review and approval under the PRA, 
44 U.S.C. 3501 et seq. Specifically, EPA has prepared an Information 
Collection Request (ICR) to estimate the potential burden and costs 
associated with the proposed requirements (Ref. 9). The ICR, which is 
available in the docket, has been assigned the EPA ICR No. 2517.01 (OMB 
Control No. 2070-[new]). You can find a copy of the ICR in the docket 
for this proposed rule (Ref. 9), and it is briefly summarized here.
    Start-Up Year Burden/Cost (Retrospective). Covers respondents/
affected entities, i.e., persons who manufacture chemical substances.
    Respondents' obligation to respond: Mandatory.
    Estimated number of respondents: 4,692.
    Frequency of response: Once and on-occasion.
    Estimated burden: 86,783 hours. The term ``burden'' is defined at 5 
CFR 1320.3(b).
    Estimated cost: $6.68 million.
    Note that an additional number of respondents (i.e., processors), 
as high as 161,550, are each assumed to undergo four hours of rule 
familiarization (about $300 per firm), but would likely not be required 
to submit information. This is based on an assumption that 100 percent 
of processor firms would undertake rule familiarization. However, EPA 
believes that it is unlikely that 100% of processors would initiate 
rule familiarization and that the actual percentage would be lower. 
Although this count, and the associated burden and costs, are not 
included in the estimates, the estimated burden and costs account for 
the bulk of total start-up costs (88%). In addition, the estimated 
burden and costs includes 469 CDX registrations in addition to NOA 
submissions.
    Ongoing Annual Burden/Cost (Forward-looking): Covers respondents/
affected entities, i.e., persons who manufacture or process chemical 
substances.
    Respondents' obligation to respond: Mandatory.
    Estimated number of respondents: 20.
    Frequency of response: On-occasion.
    Total estimated burden: 142 hours.
    Total estimated cost: $10,790.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40 CFR are listed in 40 CFR part 9 and included on any 
related collection instrument (e.g., the form).
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates and any suggested methods for 
minimizing respondent burden to EPA using the docket identified at the 
beginning of this proposed rule. You may also send your ICR-related 
comments to OMB's Office of Information and Regulatory Affairs via 
email to OIRA_submission@omb.eop.gov, Attention: Desk Officer for EPA. 
Since OMB is required to make a decision concerning the ICR between 30 
and 60 days after receipt, OMB must receive comments no later than 
February 13, 2017. EPA will respond to any ICR-related comments in the 
final rule.

[[Page 4263]]

C. Regulatory Flexibility Act (RFA)

    EPA certifies under section 605(b) of the RFA, 5 U.S.C. 601 et 
seq., that this action will not have a significant economic impact on a 
substantial number of small entities under the RFA. In making this 
determination, the impact of concern is any significant adverse 
economic impact on small entities. An agency may certify that a rule 
would not have a significant economic impact on a substantial number of 
small entities if the rule has a very small level of impact on the 
small entities subject to the rule.
    The small entities subject to the requirements of this action are 
manufacturers, and processors of chemical substances. As the most 
burdensome conditions are incurred during the start-up year for 
manufacturers, these reporters are the subject of the quantitative 
analysis with other reporters and other years assessed by inference. 
The detailed analysis is available in the docket (Ref. 10).
    The quantitative analysis addresses the ``most affected'' subset of 
entities who are expected to incur the highest typical burden under the 
proposed rule as entities manufacturing (or importing) chemicals that 
must submit NOAs involving an average of seven chemicals per entity in 
the start-up year. These small entities most directly regulated by this 
rule are small businesses in NAICS 325: Chemical Manufacturing, and 
324: Petroleum and Coal Products Manufacturing reporting during the 
start-up year. EPA has determined that all of the small entities 
(comprising about 96% of the total number of entities) within the scope 
of the quantitative analysis would experience an impact of less than 1% 
of revenues. This analysis follows EPA guidance on Regulatory 
Flexibility Act (RFA) and Small Business Regulatory Enforcement 
Fairness Act (SBREFA) analyses. Per this guidance document, the 
preferred measure of economic impacts is the ``sales test:'' Annualized 
compliance costs as a percentage of sales (or revenue or receipts when 
sales data are not readily available). This measure is termed ``cost 
impact percentage'' in the small entity analysis.
    Additional groups of small entities may be affected by the rule and 
are expected to incur similar or lesser impacts, by inference. First, 
processors submitting NOAs during the start-up year are expected to 
incur a smaller unit burden with one chemical per NOA, and therefore 
experience similar or lesser impacts than manufacturers. Secondly, all 
reporters in future years, with lower counts and relatively smaller 
unit burdens, would therefore incur much lower impact than entities 
during the start-up year, Therefore, inferences drawn regarding small 
entity impacts on the most affected group may be extended to 
characterize the impacts on processors during the start-up year and all 
entities for future years.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate as described in 
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect 
small governments. The action is not expected to impose enforceable 
duty on any state, local or tribal governments, and the requirements 
imposed on the private sector are not expected to result in annual 
expenditures of $100 million or more for the private sector. As such, 
EPA has determined that the requirements of UMRA sections 202, 203, 
204, or 205 do not apply to this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications because it would 
not have any effect on the states, on the relationship between the 
national government and the states, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132 (64 FR 43255, August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications because it is not 
expected to have any effect on tribal governments, on the relationship 
between the Federal government and the Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175 (65 
FR 67249, November 9, 2000).

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), 
as applying only to those regulatory actions that concern health or 
safety risks, such that the analysis required under section 5-501 of 
Executive Order 13045 has the potential to influence the regulation. 
This action is not subject to Executive Order 13045 because it does not 
establish an environmental standard intended to mitigate health or 
safety risks.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not 
likely to have a significant adverse effect on energy supply, 
distribution, or use.

I. National Technology Transfer and Advancement Act (NTTAA)

    Since this action does not involve any technical standards, NTTAA 
section 12(d), 15 U.S.C. 272 note, does not apply to this action.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994), because EPA has determined that this action 
would not have disproportionately high and adverse human health or 
environmental effects on minority or low-income populations. This 
action does not affect the level of protection provided to human health 
or the environment.

List of Subjects in 40 CFR Part 710

    Environmental protection, Chemicals, Reporting and Recordkeeping, 
TSCA Inventory.

    Dated: December 23, 2016.
James J. Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 710--[AMENDED]

0
1. The authority citation for part 710 would continue to read as 
follows:

    Authority: 15 U.S.C. 2607(a).

0
2. Redesignate Sec. Sec.  710.1 through 710.4 as subpart A under the 
following subpart A heading:

PART 710--COMPILATION OF THE TSCA CHEMICAL SUBSTANCE INVENTORY

Subpart A--General Provisions
Sec.
710.1 Scope and compliance.
710.3 Definitions.
710.4 Scope of the Inventory.
Subpart B--Commercial Activity Notification
710.23 Definitions.

[[Page 4264]]

710.25 Persons subject to the notification requirement.
710.27 Activities for which notification is not required.
710.29 Information required in the notification.
710.30 When to submit notifications.
710.33 Co-manufacturers and co-processors.
710.35 Recordkeeping requirements.
710.37 Confidentiality claims.
710.39 Electronic filing.
* * * * *
0
3. Revise Sec.  710.1 paragraph (b) to read as follows:

Subpart A--General Provisions


Sec.  710.1  Scope and compliance.

* * * * *
    (b) This part applies to the activities associated with the 
compilation of the TSCA Chemical Substance Inventory (TSCA Inventory) 
and the designation of chemical substances on the TSCA Inventory as 
active or inactive in U.S. commerce.
* * * * *
0
4. Revise Sec.  710.3 paragraph (d) to read as follows:


Sec.  710.3  Definitions.

* * * * *
    (d) The following definitions also apply to this part:
    Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
    Administrator means the Administrator of the U.S. Environmental 
Protection Agency, any employee or authorized representative of the 
Agency to whom the Administrator may either herein or by order delegate 
his/her authority to carry out his/her functions, or any other person 
who will by operation of law be authorized to carry out such functions.
    Article means a manufactured item (1) which is formed to a specific 
shape or design during manufacture, (2) which has end use function(s) 
dependent in whole or in part upon its shape or design during end use, 
and (3) which has either no change of chemical composition during its 
end use or only those changes of composition which have no commercial 
purpose separate from that of the article and that may occur as 
described in Sec.  710.4(d)(5); except that fluids and particles are 
not considered articles regardless of shape or design.
    Byproduct means a chemical substance produced without a separate 
commercial intent during the manufacture, processing, use, or disposal 
of another chemical substance(s) or mixture(s).
    CASRN means Chemical Abstracts Service Registry Number.
    Chemical substance means any organic or inorganic substance of a 
particular molecular identity, including any combination of such 
substances occurring in whole or in part as a result of a chemical 
reaction or occurring in nature, and any chemical element or uncombined 
radical; except that ``chemical substance'' does not include: (1) Any 
mixture; (2) any pesticide when manufactured, processed, or distributed 
in commerce for use as a pesticide; (3) tobacco or any tobacco product, 
but not including any derivative products; (4) any source material, 
special nuclear material, or byproduct material; (5) any pistol, 
firearm, revolver, shells, and cartridges; and (6) any food, food 
additive, drug, cosmetic, or device, when manufactured, processed, or 
distributed in commerce for use as a food, food additive, drug, 
cosmetic, or device.
    Commerce means trade, traffic, transportation, or other commerce 
(1) between a place in a State and any place outside of such State or 
(2) which affects trade, traffic, transportation, or commerce between a 
place in a State and any place outside of such State.
    Customs territory of the United States means the 50 States, Puerto 
Rico, and the District of Columbia.
    Distribute in commerce and distribution in commerce means to sell 
in commerce, to introduce or deliver for introduction into commerce, or 
to hold after its introduction into commerce.
    Domestic means within the geographical boundaries of the 50 United 
States, the District of Columbia, the Commonwealth of Puerto Rico, the 
Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, and 
any other territory or possession of the United States.
    EPA means the U.S. Environmental Protection Agency.
    Importer means any person who imports any chemical substance, 
including a chemical substance as part of a mixture or article, into 
the customs territory of the United States. ``Importer'' includes the 
person primarily liable for the payment of any duties on the 
merchandise or an authorized agent acting on his or her behalf. The 
term also includes, as appropriate, (1) the consignee, (2) the importer 
of record, (3) the actual owner if an actual owner's declaration and 
superseding bond has been filed in accordance with 19 CFR 141.20, or 
(4) the transferee, if the right to draw merchandise in a bonded 
warehouse has been transferred in accordance with subpart C of 19 CFR 
144.
    Impurity means a chemical substance which is unintentionally 
present with another chemical substance.
    Intermediate means any chemical substance that is consumed, in 
whole or in part, in chemical reaction(s) used for the intentional 
manufacture of other chemical substance(s) or mixture(s), or that is 
intentionally present for the purpose of altering the rate(s) of such 
chemical reaction(s).
    Inventory means the TSCA Chemical Substance Inventory, which is 
EPA's comprehensive list of confidential and non-confidential chemical 
substances manufactured or processed in the United States for non-
exempt commercial purpose that EPA compiled and keeps current under 
section 8(b) of the Act.
    Manufacture means to manufacture, produce, or import, for 
commercial purposes. Manufacture includes the extraction, for 
commercial purposes, of a component chemical substance from a 
previously existing chemical substance or complex combination of 
chemical substances. When a chemical substance, manufactured other than 
by import, is: (1) Produced exclusively for another person who 
contracts for such production, and (2) that other person specifies the 
identity of the chemical substance and controls the total amount 
produced and the basic technology for the plant process, then that 
chemical substance is co-manufactured by the producing manufacturer and 
the person contracting for such production.
    Manufacture for commercial purposes means: (1) To manufacture, 
produce, or import with the purpose of obtaining an immediate or 
eventual commercial advantage, and includes, among other things, the 
``manufacture'' of any amount of a chemical substance or mixture (i) 
for commercial distribution, including for test marketing, or (ii) for 
use by the manufacturer, including use for product research and 
development or as an intermediate. (2) The term also applies to 
substances that are produced coincidentally during the manufacture, 
processing, use, or disposal of another substance or mixture, including 
byproducts that are separated from that other substance or mixture and 
impurities that remain in that substance or mixture. Byproducts and 
impurities without separate commercial value are nonetheless produced 
for the purpose of obtaining a commercial advantage, since they are 
part of the manufacture of a chemical substance for commercial 
purposes.
    Manufacturer means a person who manufactures a chemical substance.
    Mixture means any combination of two or more chemical substances if 
the combination does not occur in nature and is not, in whole or in 
part, the result of a chemical reaction; except that

[[Page 4265]]

``mixture'' does include (1) any combination which occurs, in whole or 
in part, as a result of a chemical reaction if the combination could 
have been manufactured for commercial purposes without a chemical 
reaction at the time the chemical substances comprising the combination 
were combined, and if all of the chemical substances comprising the 
combination are not new chemical substances, and (2) hydrates of a 
chemical substance or hydrated ions formed by association of a chemical 
substance with water, so long as the nonhydrated form is itself not a 
new chemical substance.
    New chemical substance means any chemical substance which is not 
included on the Inventory.
    Person includes any individual, firm, company, corporation, joint-
venture, partnership, sole proprietorship, association, or any other 
business entity; any State or political subdivision thereof; any 
municipality; any interstate body; and any department, agency, or 
instrumentality of the Federal Government.
    Process means to process for commercial purposes. Process includes 
the preparation of a chemical substance or mixture, after its 
manufacture, (1) in the same form or physical state as, or in a 
different form or physical state from, that in which it was received by 
the person so preparing such substance or mixture, or (2) as part of a 
mixture or article containing the chemical substance or mixture.
    Process for commercial purposes means the preparation of a chemical 
substance or mixture after its manufacture for distribution in commerce 
with the purpose of obtaining an immediate or eventual commercial 
advantage for the processor. Processing of any amount of a chemical 
substance or mixture is included in this definition. If a chemical 
substance or mixture containing impurities is processed for commercial 
purposes, then the impurities also are processed for commercial 
purposes.
    Processor means any person who processes a chemical substance or 
mixture.
    Site means a contiguous property unit. Property divided only by a 
public right-of-way will be considered one site. More than one 
manufacturing plant may be located on a single site. (1) For chemical 
substances manufactured under contract, i.e., by a toll manufacturer, 
the site is the location where the chemical substance is physically 
manufactured. (2) The site for an importer who imports a chemical 
substance described in Sec.  710.25 is the U.S. site of the operating 
unit within the person's organization that is directly responsible for 
importing the chemical substance. The import site, in some cases, may 
be the organization's headquarters in the United States. If there is no 
such operating unit or headquarters in the United States, the site 
address for the importer is the U.S. address of an agent acting on 
behalf of the importer who is authorized to accept service of process 
for the importer.
    Small quantities solely for research and development (or ``small 
quantities solely for purposes of scientific experimentation or 
analysis or chemical research on, or analysis of, such substance or 
another substance, including such research or analysis for the 
development of a product'') means quantities of a chemical substance 
manufactured, imported, or processed or proposed to be manufactured, 
imported, or processed solely for research and development that are not 
greater than reasonably necessary for such purposes.
    State means any State of the United States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, 
American Samoa, the Northern Mariana Islands, or any other territory or 
possession of the United States.
    Technically qualified individual means a person (1) who because of 
his/her education, training, or experience, or a combination of these 
factors, is capable of appreciating the health and environmental risks 
associated with the chemical substance which is used under his/her 
supervision, (2) who is responsible for enforcing appropriate methods 
of conducting scientific experimentation, analysis, or chemical 
research in order to minimize such risks, and (3) who is responsible 
for the safety assessments and clearances related to the procurement, 
storage, use, and disposal of the chemical substance as may be 
appropriate or required within the scope of conducting the research and 
development activity. The responsibilities in this paragraph may be 
delegated to another individual, or other individuals, as long as each 
meets the criteria in paragraph (1) of this definition.
    Test marketing means the distribution in commerce of no more than a 
predetermined amount of a chemical substance, mixture, or article 
containing that chemical substance or mixture, by a manufacturer or 
processor to no more than a defined number of potential customers to 
explore market capability in a competitive situation during a 
predetermined testing period prior to the broader distribution of that 
chemical substance, mixture, or article in commerce.
    United States, when used in the geographic sense, means all of the 
States, territories, and possessions of the United States.
0
5. Add a new subpart B to read as follows:

Subpart B--Commercial Activity Notification


Sec.  710.23  Definitions.

    The following definitions also apply to subpart B of this part.
    Active substance means any interim active substance, any naturally 
occurring chemical substance as defined by Sec.  710.27(b), any 
substance added to the TSCA Inventory on or after June 22, 2016, and 
any chemical substance subject to commercial activity designation that 
the Administrator designated as active based on the receipt of a notice 
under this subpart.
    Central Data Exchange or CDX means EPA's centralized electronic 
document reporting portal, or its successors.
    Chemical substance subject to commercial activity designation means 
a chemical substance that requires a designation as either an active or 
an inactive substance. A chemical substance is subject to commercial 
activity designation if it was added to the TSCA Inventory before June 
22, 2016, it is not an interim active substance, it is not a naturally 
occurring chemical substance as defined by Sec.  710.27(b), and it has 
not yet been designated by the Administrator as either an active or an 
inactive substance.
    Chemical Information Submission System or CISS means EPA's web-
based reporting tool for preparing and submitting a Notice of Activity.
    e-NOA means EPA's software module within CISS for generating and 
completing Notice of Activity forms A and B.
    Existing claim for protection of specific chemical identity against 
disclosure is a claim to continue protection of specific chemical 
identity of a chemical substance that is listed on the confidential 
portion of the TSCA Inventory.
    Inactive substance means any chemical substance subject to 
commercial activity designation, that the Administrator designates as 
inactive based on the lack of receipt of a notice under this subpart.
    Interim active substance means any chemical substance that was 
reported, pursuant to 40 CFR part 711, as having been manufactured in 
either 2010 or 2011. After such time when EPA has made public a 
compiled list of chemical

[[Page 4266]]

substances that were reported, pursuant to 40 CFR part 711, as having 
been manufactured in either 2012, 2013, 2014, or 2015, the term shall 
also include any such additional chemical substances that were there 
reported as having been manufactured in those additional years.
    Known to or reasonably ascertainable by means all information in a 
person's possession or control, plus all information that a reasonable 
person similarly situated might be expected to possess, control, or 
know.
    Lookback period means the period beginning on June 21, 2006 and 
ending on June 21, 2016.
    Reportable chemical substance means a chemical substance that is 
listed on the TSCA Inventory and that is either: (1) A chemical 
substance subject to commercial activity designation for which 
notification is required or allowed under Sec.  710.25(a) and Sec.  
710.25(b), (2) an interim active substance for which notification is 
required under Sec.  710.25(a), or (3) an inactive substance for which 
notification is required under Sec.  710.25(c).
    Submission period means the applicable period for submitting a 
Notice of Activity under Sec.  710.25.


Sec.  710.25   Persons subject to the notification requirement.

    The following persons are subject to the requirements of this 
subpart.
    (a) Who must submit the Notice of Activity Form A? Any person who 
manufactured a chemical substance subject to commercial activity 
designation or who manufactured an interim active substance that is on 
the confidential portion of the TSCA Inventory, at any time during the 
lookback period, except as provided in Sec.  710.27, must submit a 
Notice of Activity Form A as specified under Sec.  710.29 and Sec.  
710.30.
    (b) Who else may submit the Notice of Activity Form A? Any person 
who processed a chemical substance subject to commercial activity 
designation, at any time during the lookback period, except as provided 
in Sec.  710.27, may submit a Notice of Activity Form A as specified 
under Sec.  710.29 and Sec.  710.30.
    (c) Who must submit the Notice of Activity Form B? Any person who 
intends to manufacture or process an inactive chemical substance, 
except as provided in Sec.  710.27, after the effective date of the 
Administrator's designation of such chemical substance as an inactive 
substance, must submit a Notice of Activity Form B as specified under 
Sec.  710.29 and Sec.  710.30.


Sec.  710.27  Activities for which notification is not required.

    (a) In general. The following activities do not trigger 
notification requirements under this subpart:
    (1) The manufacturing or processing of a chemical substance solely 
in small quantities for research and development.
    (2) The import of a chemical substance as part of an article.
    (3) The manufacturing or processing of a chemical substance as 
described in Sec.  720.30(g) or (h).
    (b) Manufacturing or processing naturally occurring chemical 
substances. The following activities do not trigger notification 
requirements under this subpart:
    (1) The manufacture of a naturally occurring chemical substance, as 
described in Sec.  710.4(b). Some chemical substances can be 
manufactured both as described in Sec.  710.4(b) and by means other 
than those described in Sec.  710.4(b). If a person manufactures a 
chemical substance by means other than those described in Sec.  
710.4(b), this exemption is inapplicable, regardless of whether the 
chemical substance also could have been produced as described in Sec.  
710.4(b). This exemption does not cover the manufacture of a chemical 
substance from a naturally occurring chemical substance.
    (2) The processing of a naturally occurring chemical substance only 
by manual, mechanical, or gravitational means; by dissolution in water; 
by flotation; or by heating solely to remove water.


Sec.  710.29   Information required in the notification.

    (a) Reporting information to EPA. Any person who reports 
information to EPA, including post-notification substantiation of 
confidentiality claims under Sec.  710.37(b), must do so using the e-
NOA software module, the CISS reporting tool, and the CDX electronic 
reporting portal provided by EPA at the addresses set forth in Sec.  
710.39. For notices of activity under Sec.  710.25(a) and Sec.  
710.25(b), the submission must include all information described in 
paragraph (b) of this section. For a Notice of Activity under Sec.  
710.25(c), the submission must include all information described in 
paragraph (c) of this section. A person must submit a separate form for 
each chemical substance that the person is required to report. CDX, 
CISS, and e-NOA allow a person to report multiple chemical substances 
in one session that will be transmitted to EPA on separate forms. Using 
e-NOA and registering in CDX are described in instructions available 
from EPA at the Web sites set forth in Sec.  710.39.
    (b) Information to be reported on the Notice of Activity Form A. 
Any person submitting a Notice of Activity Form A under Sec.  710.25(a) 
or Sec.  710.25(b) must submit the information described in this 
paragraph for each reportable chemical substance during the submission 
period specified in Sec.  710.30(a). A person submitting information 
under Sec.  710.25(a) or Sec.  710.25(b) must report information to the 
extent that such information is known to or reasonably ascertainable by 
that person. A notice must be submitted for each chemical substance for 
which the person is required to report. A person reporting information 
under Sec.  710.25(a) or Sec.  710.25(b) must report the following:
    (1) Information specified in Sec.  710.29(d).
    (2) The type of commercial activity for each reportable chemical 
substance: Whether the chemical substance was domestically manufactured 
in the United States, imported into the United States, or both 
domestically manufactured in the United States and imported into the 
United States during the lookback period.
    (3) The first date and the last date that each reportable chemical 
substance was domestically manufactured in the United States, imported 
into the United States, or both domestically manufactured in the United 
States and imported into the United States during the lookback period.
    (c) Information to be reported on a Notice of Activity Form B. Any 
person submitting a Notice of Activity Form B under Sec.  710.25(c) 
must provide the information described in this paragraph for each 
inactive chemical substance intended to be manufactured or processed at 
the time specified in Sec.  710.30(b). A person submitting information 
under Sec.  710.25(c) must report information to the extent that such 
information is known to or reasonably ascertainable by that person. A 
notice must be submitted for each chemical substance that the person 
intends to manufacture or process. A person submitting a notice of 
activity under Sec.  710.25(c) must report the following:
    (1) Information specified in Sec.  710.29(d).
    (2) The type of intended commercial activity for the inactive 
substance: Whether the inactive substance is intended to be 
domestically manufactured in the United States, imported into the 
United States, processed in the United States, or a particular 
combination of these.

[[Page 4267]]

    (3) The actual date by which the inactive substance is to be 
domestically manufactured in the United States, imported into the 
United States, or processed in the United States.
    (d) Information to be reported on either the Notice of Activity 
Form A or Form B.
    (1) Company. The name of the submitting company.
    (2) Authorized official. The name and address of the authorized 
official for the submitting company.
    (3) Technical contact. The name and telephone number of a person 
who will serve as technical contact for the submitting company and who 
will be able to answer questions about the information submitted by the 
company to EPA.
    (4) Chemical-specific information. The correct CA Index name as 
used to list the chemical substance on the Inventory and the correct 
corresponding CASRN must be submitted for each reportable chemical 
substance. Persons who wish to report chemical substances listed on the 
confidential portion of the TSCA Inventory must report the chemical 
substances using a TSCA Accession Number and generic name.
    (i) If an importer submitting a notice cannot provide the 
information specified in Sec.  710.29(d)(4) because it is unknown to 
the importer and claimed as confidential by the supplier of the 
chemical substance or mixture, the importer must ask the supplier to 
provide the specific chemical identity information directly to EPA in a 
joint submission using the same e-NOA software module used for 
commercial activity reporting. Such request must include instructions 
for submitting chemical identity information electronically, using e-
NOA, CISS, and CDX (see Sec.  710.39), and for clearly referencing the 
importer's submission. Contact information for the supplier, a trade 
name or other name for the chemical substance or mixture, and a copy of 
the request to the supplier must be included with the importer's 
submission with respect to the chemical substance.
    (ii) If a manufacturer or processor submitting a notice cannot 
provide the information specified in Sec.  710.29(d)(4) because the 
reportable chemical substance is manufactured or processed using a 
reactant having a specific chemical identity that is unknown to the 
manufacturer or processor and claimed as confidential by its supplier, 
the manufacturer or processor must ask the supplier of the confidential 
reactant to provide the specific chemical identity of the confidential 
reactant directly to EPA in a joint submission using the same e-NOA 
software module used for commercial activity reporting. Such request 
must include instructions for submitting chemical identity information 
electronically using e-NOA, CISS, and CDX (see Sec.  710.39), and for 
clearly referencing the manufacturer's or processor's submission. 
Contact information for the supplier, a trade name or other name for 
the chemical substance, and a copy of the request to the supplier must 
be included with the manufacturer's or processor's submission with 
respect to the chemical substance.
    (iii) EPA will only accept joint submissions that are submitted 
electronically using e-NOA, CISS, and CDX (see Sec.  710.39) and that 
clearly reference the primary submission to which they refer.
    (5) Certification statement. The authorized official must certify 
that the submitted information has been completed in compliance with 
the requirements of this part and that the confidentiality claims made 
on the form are true and correct using the certification statement in 
this paragraph.
    (i) The certification must be signed and dated by the authorized 
official for the submitting company.
    (ii) The following is the required certification language:
    ``I certify under penalty of law that this document and all 
attachments were prepared under my direction or supervision and the 
information contained therein, to the best of my knowledge is, true, 
accurate, and complete. I am aware there are significant penalties for 
submitting incomplete, false and/or misleading information, including 
the possibility of fine and imprisonment for knowing violations.''


Sec.  710.30   When to submit notifications.

    (a) When must a Notice of Activity Form A be submitted? The Notice 
of Activity Form A required to be submitted under Sec.  710.25(a) must 
be submitted during the applicable submission period.
    (1) Manufacturers. The submission period for manufacturers under 
Sec.  710.25(a) begins on [date on which the final rule is published in 
the Federal Register] and ends on [180 days after the date on which the 
final rule is published in the Federal Register].
    (2) Processors. The submission period for processors under Sec.  
710.25(b) begins on [date on which the final rule is published in the 
Federal Register] and ends on [360 days after the date on which the 
final rule is published in the Federal Register].
    (b) When must a Notice of Activity Form B be submitted? The Notice 
of Activity Form B required to be submitted under Sec.  710.25(c) must 
be submitted before a person manufactures or processes the inactive 
substance, but not more than 30 days prior to the actual date of 
manufacturing or processing.


Sec.  710.33   Co-manufacturers and co-processors.

    (a) Notice of Activity submitted by co-manufacturers. When, in a 
single instance of manufacturing or importing a particular volume of a 
chemical substance during the lookback period, two or more persons 
qualify as the manufacturer or importer of that volume, they may 
determine among themselves who should make the required submission 
under Sec.  710.25(a). If no notice is submitted as required under this 
subpart, EPA will hold each such person liable for failure to submit a 
notice.
    (b) Notice of activity by prospective co-manufacturers or co-
processors. If two or more persons intend to manufacture, import, or 
process a particular volume of an inactive substance, such that 
multiple persons would qualify as the manufacturer, importer, or 
processor of that volume, they may determine among themselves who will 
submit the required notice under Sec.  710.25(c). If no notice is 
submitted as required under this subpart, all of the persons remain 
subject to the reporting requirements, and EPA will hold each such 
person liable for a failure to submit a notice prior to the date of 
manufacturing, importing, or processing.


Sec.  710.35   Recordkeeping requirements.

    Each person who is subject to the notification requirements of this 
part must retain records that document any information reported to EPA. 
Records relevant to a notice of activity under Sec.  710.25(a) and 
Sec.  710.25(b) must be retained for a period of 5 years beginning on 
the last day of the submission period. Records relevant to a notice of 
activity under Sec.  710.25(c) must be retained for a period of 5 years 
beginning on the day that the notice was submitted.


Sec.  710.37   Confidentiality claims.

    (a) Chemical identity. Any persons submitting information under 
this part may request to maintain an existing claim of confidentiality 
for the specific chemical identity of a reportable chemical substance 
only if the identity of the chemical substance is listed on the 
confidential portion of the TSCA

[[Page 4268]]

Inventory as of the time the notice is submitted for that chemical 
substance under this part. Any such requests to maintain an existing 
claim of confidentiality must be made at the time the information is 
submitted. If no person submitting the information specified in Sec.  
710.29(d)(4) for a particular chemical substance requests that the 
claim be maintained, EPA will treat the specific chemical identity of 
that chemical substance as not subject to a confidentiality claim and 
will move the chemical substance to the public portion of the TSCA 
Inventory. Except as set forth in this subsection, information claimed 
as confidential in accordance with this section will be treated and 
disclosed in accordance with the procedures in 40 CFR part 2. The 
following steps must be taken to maintain an existing claim of 
confidentiality for the specific chemical identity of a reportable 
chemical substance.
    (1) Substantiation of requests.
    (i) Notice of Activity Form A. A person requesting to maintain an 
existing claim of confidentiality for specific chemical identity may 
submit with the notice detailed written answers to the questions in 
paragraph (1)(iii) of this section, signed and dated by an authorized 
official. If these early answers are received less than five years 
before the date on which substantiation is due pursuant to TSCA Section 
8(b)(4)(D)(i) the early answers will be deemed to be substantiations 
made under TSCA Section (8)(b)(4)(D)(i) and the person will be exempt 
from further substantiation requirements under Section (8)(b)(4)(D)(i). 
Early answers that do not include the answers to questions in paragraph 
(1)(iii) of this section will not be deemed to be substantiations made 
under the TSCA section (8)(b)(4)(D)(i) requirement.
    (ii) Notice of Activity Form B. A person requesting to maintain an 
existing claim of confidentiality for specific chemical identity must 
submit detailed written answers to the questions in paragraph (1)(iii) 
of this section within 30 days of submitting the notice, signed and 
dated by an authorized official. If this information is not submitted 
within 30 days of submitting the notice, EPA will consider the specific 
chemical identity as not subject to a confidentiality claim and may 
make the information public without further notice.
    (iii) Substantiation questions.
    (A) What harmful effects to your competitive position, if any, or 
to your supplier's competitive position, do you think would result from 
the identity of the chemical substance being disclosed in connection 
with reporting under this part? How could a competitor use such 
information? Would the effects of disclosure be substantial? What is 
the causal relationship between the disclosure and the harmful effects?
    (B) How long should confidential treatment be given? Until a 
specific date, the occurrence of a specific event, or permanently? Why?
    (C) Has the chemical substance been patented? If so, have you 
granted licenses to others with respect to the patent as it applies to 
the chemical substance? If the chemical substance has been patented and 
therefore disclosed through the patent, why should it be treated as 
confidential?
    (D) Has the identity of the chemical substance been kept 
confidential to the extent that your competitors do not know it is 
being manufactured for a commercial purpose by anyone?
    (E) Is the fact that the chemical substance is being manufactured 
for a commercial purpose available to the public, for example in 
technical journals, libraries, or State, local, or Federal agency 
public files?
    (F) What measures have been taken to prevent undesired disclosure 
of the fact that the chemical substance is being manufactured for a 
commercial purpose?
    (G) To what extent has the fact that this chemical substance is 
manufactured for commercial purposes been revealed to others? What 
precautions have been taken regarding these disclosures? Have there 
been public disclosures or disclosures to competitors?
    (H) Does this particular chemical substance leave the site of 
manufacture in any form, e.g., as product, effluent, emission? If so, 
what measures have been taken to guard against the discovery of its 
identity?
    (I) If the chemical substance leaves the site in a product that is 
available to the public or your competitors, can the chemical substance 
be identified by analysis of the product?
    (J) For what purpose do you manufacture the chemical substance?
    (K) Has EPA, another Federal agency, or any Federal court made any 
pertinent confidentiality determinations regarding this chemical 
substance? If so, please attach copies of such determinations.
    (2) Identification of claims. If any of the information contained 
in the answers to the questions listed in paragraph (a)(1)(iii) of this 
section is asserted to be confidential, the submitter must clearly 
identify the information that is claimed as confidential by marking the 
specific information on each page with a label such as ``confidential 
business information,'' ``proprietary,'' or ``trade secret.''
    (b) Information other than specific chemical identity. Any persons 
submitting information under this part may assert a claim of 
confidentiality for information other than specific chemical identity. 
Any such confidentiality claims must be made at the time the 
information is submitted. Confidentiality claims will apply only to the 
information submitted with the claim. Confidentiality claims cannot be 
made when a response field on a reporting form is left blank or 
designated as not known or reasonably ascertainable. Except as set 
forth in this section, information claimed as confidential in 
accordance with this subsection will be treated and disclosed in 
accordance with 40 CFR part 2. The following steps must be taken to 
assert a claim of confidentiality for information other than specific 
chemical identity. If no claim is asserted at the time the information 
is submitted, or if the following steps are not taken, EPA will 
consider the information as not subject to a confidentiality claim and 
may make the information public without further notice.
    (1) Substantiation of claims. A person asserting a claim of 
confidentiality for information other than specific chemical identity 
must submit detailed written answers to the following questions at the 
time of submission, signed and dated by an authorized official.
    (i) For what period of time do you request that the information be 
maintained as confidential, e.g., until a certain date, until the 
occurrence of a specified event, or permanently? If the occurrence of a 
specific event will eliminate the need for confidentiality, please 
specify that event.
    (ii) Information submitted to the EPA becomes stale over time. Why 
should the information you claim as confidential be protected for the 
time period specified in your answer to question #1?
    (iii) What measures have you taken to protect the information 
claimed as confidential? Have you disclosed the information to anyone 
other than a governmental body or someone who is bound by an agreement 
not to disclose the information further? If so, why should the 
information be considered confidential?
    (iv) Is the information contained in any publicly available 
material such as the Internet, publicly available databases, 
promotional publications, annual reports, or articles? If so, specify 
which.

[[Page 4269]]

    (v) Is there any means by which a member of the public could obtain 
access to the information? Is the information of a kind that you would 
customarily not release to the public?
    (vi) Has any governmental body made a determination as to the 
confidentiality of the information? If so, please attach a copy of the 
determination.
    (vii) For each item or category of information claimed as 
confidential, explain with specificity why release of the information 
is likely to cause substantial harm to your competitive position. 
Explain the specific nature of those harmful effects, why they should 
be viewed as substantial, and the causal relationship between 
disclosure and such harmful effects. How could your competitors make 
use of this information to your detriment?
    (viii) Do you assert that the information is submitted on a 
voluntary or a mandatory basis? Please explain the reason for your 
assertion. If you assert that the information is voluntarily submitted 
information, please explain whether the information is the kind that 
would customarily not be released to the public.
    (ix) Whether you assert the information as voluntary or 
involuntary, please address why disclosure of the information would 
tend to lessen the availability to the EPA of similar information in 
the future.
    (x) If you believe any information to be (a) trade secret(s), 
please so state and explain the reason for your belief. Please attach 
copies of those pages containing such information with brackets around 
the text that you claim to be (a) trade secret(s).
    (xi) Explain any other issue you deem relevant.
    (2) Identification of claims. If any of the information contained 
in the answers to the questions listed in paragraph (b)(1) of this 
section is asserted to be confidential, the submitter must clearly 
identify the information that is claimed as confidential by marking the 
specific information on each page with a label such as ``confidential 
business information,'' ``proprietary,'' or ``trade secret.''
    (3) Certification statement for claims. In submitting a claim of 
confidentiality, a person must certify the truth of the following four 
statements concerning all information which is claimed as confidential:
    (i) My company has taken reasonable measures to protect the 
confidentiality of the information.
    (ii) I have determined that the information is not required to be 
disclosed or otherwise made available to the public under any other 
Federal law.
    (iii) I have a reasonable basis to conclude that disclosure of the 
information is likely to cause substantial harm to the competitive 
position of the person.
    (iv) I have a reasonable basis to believe that the information is 
not readily discoverable through reverse engineering.


Sec.  710.39   Electronic filing.

    (a) EPA will accept information submitted under this subpart only 
if submitted in accordance with this section. All information must be 
submitted electronically to EPA via CDX. Prior to submission to EPA via 
CDX, Notices of Activity and any associated information must be 
generated and completed using the e-NOA software module.
    (b) Obtain instructions for registering in CDX as follows:
    (1) Web site. The CDX Registration User Guide is available at 
https://www.epa.gov/sites/production/files/documents/cdx_registration_guide_v0_02.pdf. To register in CDX, go to https://cdx.epa.gov and follow the appropriate links.
    (2) Telephone. Contact the EPA CDX Help Desk at 1-888-890-1995.
    (3) Email. Email the EPA CDX Help Desk at HelpDesk@epacdx.net.
    (c) Obtain instructions for using the e-NOA software module as 
follows:
    (1) Web site. Go to the EPA New Chemicals under the Toxic 
Substances Control Act Web site at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn and 
follow the appropriate links.
    (2) Telephone. Contact the EPA TSCA Hotline at 1-202-554-1404.
    (3) Email. Email the EPA TSCA Hotline at TSCA-Hotline@epa.gov.

[FR Doc. 2016-31923 Filed 1-12-17; 8:45 am]
 BILLING CODE 6560-50-P