[Federal Register Volume 82, Number 8 (Thursday, January 12, 2017)]
[Rules and Regulations]
[Pages 3641-3655]
[FR Doc No: 2017-00052]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 704

[EPA-HQ-OPPT-2010-0572; FRL-9957-81]
RIN 2070-AJ54

Chemical Substances When Manufactured or Processed as Nanoscale
Materials; TSCA Reporting and Recordkeeping Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is establishing reporting and recordkeeping requirements
for certain chemical substances when they are manufactured or processed
at the nanoscale as described in this rule. Specifically, EPA is
requiring persons that manufacture (defined by statute to include
import) or process, or intend to manufacture or process these chemical
substances to electronically report to EPA certain information, which
includes insofar as known to or reasonably ascertainable by the person
making the report, the specific chemical identity, production volume,
methods of manufacture and processing, exposure

and release information, and existing information concerning
environmental and health effects. This rule involves one-time reporting
for existing discrete forms of certain nanoscale materials, and a
standing one-time reporting requirement for new discrete forms of
certain nanoscale materials before those new forms are manufactured or
processed.

DATES: This final rule is effective May 12, 2017.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2010-0572, is available
electronically at http://www.regulations.gov or in person at the Office
of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental
Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC.
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
OPPT Docket is<PHONE_NUMBER>. Please review the visitor instructions
and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:  For technical information contact:
Jim Alwood, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8974; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Who does this action apply to?

    You may be potentially affected by this action if you manufacture
or process or intend to manufacture or process nanoscale forms (forms
with particle sizes of 1-100 nm) of certain chemical substances as
defined in section 3 of TSCA. You are not manufacturing or processing a
TSCA chemical substance when you are manufacturing or processing a
chemical for use as, e.g., a pesticide (as defined in the Federal
Insecticide, Fungicide, and Rodenticide Act), food, food additive,
drug, cosmetic or device (as such terms are defined in section 201 of
the Federal Food, Drug, and Cosmetic Act). However, persons that
manufacture or process, or intend to manufacture or process these
chemical substances as part of articles, as impurities, or in small
quantities solely for research and development will not be subject to
this action. In addition, the discussion in Unit III. describes in more
detail which chemical substances will and will not be subject to
reporting under the rule. You may also consult 40 CFR 704.3 and 704.5,
as well as the regulatory text in this document, for further
information on the applicability of these and other exemptions to this
rule.
    The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document may
apply to them:
     Chemical Manufacturing or Processing (NAICS codes 325).
     Synthetic Dye and Pigment Manufacturing (NAICS code
325130).
     Other Basic Inorganic Chemical Manufacturing (NAICS code
325180).
     Rolled Steel Shape Manufacturing (NAICS code 331221).
     Semiconductor and Related Device Manufacturing (NAICS code
334413).
     Carbon and Graphite Product Manufacturing (NAICS code
335991).
     Home Furnishing Merchant Wholesalers (NAICS code 423220).
     Roofing, Sliding, and Insulation Material Merchant
Wholesalers (NAICS code 423330).
     Metal Service Centers and Other Metal Merchant Wholesalers
(NAICS code 423510).

B. What action is the Agency taking?

    On April 6, 2015 (80 FR 18330; FRL-9920-90) (Ref. 1), EPA proposed
reporting and recordkeeping requirements for persons that manufacture
(including import) or process certain chemical substances as described
in the proposed rule. EPA received numerous public comments and
conducted a public meeting on June 11, 2015 to obtain additional public
input. This final rule is based on that proposal and the consideration
of the public comments received.
    This TSCA section 8(a) rule requires one-time reporting of certain
information, including specific chemical identity, production volume,
methods of manufacture and processing, use, exposure and release
information, and available health and safety information; as well as
keeping records of this information for 3 years. EPA is finalizing the
proposed requirements with changes to the definition of a reportable
chemical substance, including a definition of unique and novel
properties and a numerical value to replace the proposed term of trace
amounts. There are also additional exemptions to reporting for certain
biological materials, while zinc oxide and nanoclays are no longer
exempt from reporting. The definition of a small manufacturer or
processor exempt from reporting requirements has been changed. These
changes, the reasons for the changes, and other clarifications are
discussed in more detail in Unit III. EPA has also prepared a detailed
response to public comments document (Ref. 2) that is available in the
docket. EPA's responses to some of those comments are summarized in
Unit III.

C. Why is the Agency taking this action?

    These reporting and recordkeeping requirements will assist EPA in
its continuing evaluation of chemical substances manufactured at the
nanoscale, informed by available scientific, technical and economic
evidence. As with current new chemical reviews of chemical substances
manufactured at the nanoscale, each nanoscale material derived from
substances on the TSCA inventory would be evaluated on a case-by-case
basis without a presumption of either harm or safety. Any evaluation
will be based on the specific nanoscale material's own properties and
those of any structural analogs.
    As indicated in the proposed rule, the requirements of the rule are
not based on an assumption that nanoscale materials as a class, or
specific uses of nanoscale materials, necessarily give rise to or are
likely to cause harm to people or the environment. Rather, any
information gathered under this rule will facilitate EPA's
determination of whether further action, including additional
information collection, is needed for that specific nanoscale material.
Consistent with the President's memorandums for Executive Agencies
regarding Principles for Regulation and Oversight of Emerging
Technologies and U.S. Decision-Making Concerning Regulation and
Oversight of Applications of Nanotechnology and Nanomaterials (Ref. 3),
this rule will facilitate assessment of risks and risk management,
examination of the benefits and costs of further measures, and making
future decisions based on available scientific evidence.
    In addition, EPA will not publish an inventory of chemical
substances manufactured at the nanoscale based on the information that
will be collected pursuant to the rule. EPA will make non-confidential
information reported

under the rule available in ChemView (see http://www.epa.gov/chemview/
).

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

    As described in more detail in Unit II.A. of the proposed rule, the
Toxic Substances Control Act as amended by the Frank R. Lautenberg
Chemical Safety for the 21st Century Act (TSCA), 15 U.S.C. 2601 et
seq., provides EPA with authority to require reporting, recordkeeping
and testing, and impose restrictions relating to chemical substances
and/or mixtures. 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.
    EPA is issuing this rule under TSCA section 8(a), 15 U.S.C.
2607(a), in compliance with the requirements of section 8(a)(5). Under
TSCA section 8(a)(5)(A) EPA is to the extent feasible: (A) Not require
reporting which is unnecessary or duplicative; (B) minimize the cost of
compliance with this section and the rules issued thereunder on small
manufacturers and processors; and (C) apply any reporting obligations
to those persons likely to have information relevant to the effective
implementation of TSCA. As noted in the response to comments several
elements of this rule address duplicative reporting such as the
exemption for chemical substances that are nanoscale materials that
have already been reported under section 5 of TSCA and for the
exemption for information already submitted under the Nanoscale
Materials Stewardship Program. The response also explains why this rule
does not duplicate chemical data reporting (CDR) under 40 CFR part 711.
EPA's economic analysis demonstrated that this rule would not have a
significant adverse economic impact on a substantial number of small
entities. The rationale supporting this conclusion is summarized in
Unit V.C. of this rule and is presented in the small entity impact
analysis that EPA prepared for this action as part of the Agency's
economic analysis in the public docket for this rule. This rule focuses
on manufacturers and processors of chemical substances as nanoscale
materials with unique and novel properties which are the persons likely
to have relevant information on nanoscale materials in commerce.

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

    EPA has evaluated the potential costs of this reporting and
recordkeeping requirement for manufacturers and processors. This
analysis (Ref. 4), which is available in the docket, is briefly
summarized here.
    Industry is conservatively estimated to incur a burden of
approximately 360,000 hours in the first year and 40,100 hours in
subsequent years, with costs of approximately $27.79 million and $3.09
million, respectively (see Chapter 3 in Ref. 4), while the Agency is
expected to use approximately 16,300 hours in the first year and 1,800
hours in subsequent years, with costs of approximately $1.34 million
and $0.15 million respectively (see Chapter 4 in Ref. 4). Discounted
over a 10-year period at three and seven percent, total annualized
social costs are estimated to be approximately $5.71 million and $6.26
million, respectively. (Ref. 4).

II. Overview of the Final Rule

    EPA is describing in this unit the reporting and recordkeeping
requirements for manufacturers and processors of certain chemical
substances pursuant to TSCA section 8(a). A processor is someone who
prepares a chemical substance or mixture after its manufacture for
distribution in commerce. Processor activities include a variety of
activities. Some examples of processing of a chemical substance are
developing or modifying formulations for additional processing or use
in commercial applications, incorporating a chemical substance into
articles, and using the chemical substance to form other chemical
substances.

A. What chemical substances are reportable under this rule?

    1. Reportable chemical substances. This rule applies to chemical
substances, as defined in section 3 of TSCA, that are solids at 25
[deg]C and standard atmospheric pressure; that are manufactured or
processed in a form where any particles, including aggregates and
agglomerates, are in the size range of 1-100 nanometers (nm) in at
least one dimension; and that are manufactured or processed to exhibit
one or more unique and novel properties. This rule does not apply to
chemical substances manufactured or processed in forms that contain
less than 1% by weight of any particles, including aggregates and
agglomerates, in the size range of 1-100 nm. These parameters are for
purposes of identifying chemical substances that are subject to the
rule and do not establish a definition of nanoscale material.
    EPA added a definition of unique and novel properties in the
definitions section of the regulatory text (See 704.20(a)). Unique and
novel properties means any size-dependent properties that vary from
those associated with other forms or sizes of the same chemical
substance, and such properties are a reason that the chemical substance
is manufactured or processed in that form or size. A reportable
chemical substance is not just a substance containing particles in the
size range of 1-100 nm; it must also demonstrate a size-dependent
property different from properties at sizes greater than 100 nm and is
a reason the chemical is manufactured or processed in that form or
size. Chemical substances manufactured or processed at the nanoscale
that contain incidental amounts of particles in the size range of 1-100
nm are not reportable chemical substances. EPA used ``trace amounts''
in the proposed rule to define this concept. However, based on the
public comments to better define trace amounts including several
comments to establish a numerical value, EPA is now using a numerical
value of less than 1% of particles from 1-100 nm by weight to define
those chemical substances that are not reportable.
    i. Discrete forms. Manufacturers and processors of multiple
nanoscale forms of the same chemical substance will, in some cases,
need to report separately for each discrete form of the reportable
chemical substance. Reporting of these discrete forms are not the same
as new chemical reporting under TSCA section 5. The rule distinguishes
between discrete forms in three different ways. The first is based on a
combination of three factors: (1) A change in process to effect a
change in size, a change in properties of the chemical substances
manufactured at the nanoscale, or both; (2) a change in mean particle
size greater than 7 times the standard deviation of the measured values
(7 times the standard deviation); and (3) the change in at
least one of the following properties, zeta potential, specific surface
area, dispersion stability, or surface reactivity, is greater than 7
times the standard deviation of the measured values (7
times the standard deviation).
    For example, if the specific surface area of one discrete form was
measured to be 50 m\2\/g with a standard deviation of 5
m\2\/g, then a change resulting in a new average specific surface area
of 85 m\2\/g would result in a discrete form of a reportable chemical
substance, if factors 1 and 2 were also met. While testing is not
required, if performing the test EPA recommends using the same test
medium and method when measuring the change in these properties, as
even minor changes in the

medium and methods can result in large differences in the measured
results. EPA's intent for these reporting requirements is to focus
reporting on chemical substances on the TSCA inventory that are
intentionally manufactured at the nanoscale.
    It is the combination of the above three factors, rather than
simply size, which distinguishes between different forms of a chemical
substance manufactured at the nanoscale, so that unintended variation
in size range between production batches does not trigger separate
reporting for each batch. The rule does not rely solely on process
changes because there may be process changes that are not intended to
change the material produced, but rather are intended to improve the
efficiency of the process or to use a less expensive reactant. EPA is
focusing on the properties of zeta potential, specific surface area,
dispersion stability, and surface reactivity because these properties
are of particular interest in health and safety evaluation. Other
properties of chemical substances manufactured at the nanoscale (e.g.,
the wavelength at which light is emitted) may be important for how that
form of the chemical substance functions but are less likely to be
relevant to hazard, fate, exposure, or risk. The combination of the
above three factors provides a clear and transparent way to distinguish
among discrete forms of chemical substances manufactured at the
nanoscale for purposes of TSCA section 8(a) reporting.
    For the purposes of this rule, specific surface area is the ratio
of the surface area of the nanoscale material to its mass (m\2\/kg), or
the area of the surface of the nanoscale material divided by volume
(m\2\/m\3\). This is an important factor because chemical reactions
take place at the surface of the material. Thus, the higher the surface
area, the greater the chemical reactivity, which is an important
consideration for human health toxicity and environmental toxicity
assessments.
    Zeta potential is the electrostatic potential near the particle
surface. It can be measured using various methods. See the
International Organization for Standardization (ISO) ISO/TR 13014:2012
``Guidance on Physicochemical Characterization for Manufactured Nano-
objects Submitted for Toxicological Testing'' (Ref. 5) and the
description of zeta potential by Colloidal Dynamics (Ref. 6) for
examples. It is typically measured by electrophoresis. This is also an
important factor as it measures chemical reactivity at the particle
surface.
    Dispersion stability is the ability of a dispersion to resist
changes in properties over time and can be defined in terms of the
change in one or more physical properties over a given time period. See
ISO/TR 13097:2013 ``Guidelines for characterization of dispersion
stability'' (Ref. 7) as an example. Changes in dispersion stability
affect physical properties that in turn can affect the environmental
fate and hazard properties of a chemical substance.
    Surface reactivity is the degree to which the nanoscale material
will react with biological systems. The surface reactivity of the form
of a chemical substance is dependent upon factors such as redox
potential, which is a measure of the tendency of a chemical species to
lose or acquire electrons, and photocatalytic activity, including the
potential to generate free radicals. Reactive oxygen species and free
radicals are important in considering toxicity for these materials.
    The second way of distinguishing a discrete nanoscale form of a
particular chemical substance is by morphology or shape. Examples
include spheres, rods, ellipsoids, cylinders, needles, wires, fibers,
cages, hollow shells, trees, flowers, rings, tori, cones, and sheets.
The third way is that forms of a reportable chemical substance that are
coated with different chemical substances would be considered discrete
forms for each chemical coating.
    ii. Chemical mixtures. Chemical substances that are manufactured or
processed in a nanoscale form for the purposes of being sold to others
for use as a component of a mixture, encapsulated material, or
composite are subject to reporting. Chemical substances at the
nanoscale that are manufactured but are then incorporated into
mixtures, encapsulated materials or composites by that manufacturer do
not require separate reporting for their incorporation. However, the
person reporting as to the chemical substance must report the
information required as to each step of its manufacture, processing and
use to the extent it is known or reasonably ascertainable.
    2. Substances excluded from reporting. EPA is excluding from the
requirements of this rule certain biological materials including DNA,
RNA, proteins, enzymes, lipids, carbohydrates, peptides, liposomes,
antibodies, viruses, and microorganisms.
    EPA is excluding chemical substances which dissociate completely in
water to form ions with a size of less than 1 nm. This exclusion does
not apply to chemical substances manufactured at the nanoscale that
release ions but do not dissociate in water to form those ions.
Chemical substances that dissociate completely in water to form ions
with a size of less than 1 nm do not exhibit new size-dependent
properties because the same properties would manifest in the
dissociated form regardless of whether the substance is at the
nanoscale before dissociation. Manufacturing or processing such
substances are therefore not subject to the reporting requirements of
the rule.
    EPA is excluding chemical substances formed at the nanoscale as
part of a film on a surface. See the explanation in Unit III. for the
changes from the proposed rule and the detailed response to comments in
the docket for EPA's explanation and reasoning.
    3. General exemptions to TSCA Section 8(a) reporting. The general
exemptions to TSCA section 8(a) reporting at 40 CFR 704.5 are
applicable to this rule. These include, among other exemptions, the
exemption for research and development (R&D) under which a person who
manufactures or processes a chemical substance only in small quantities
for research and development is exempt from the reporting requirements
of this rule. Examples of R&D activity are the analysis of the chemical
or physical characteristics, the performance, or the production
characteristics of a chemical substance. It can include production of a
chemical substance for use by others in their R&D activities. R&D
activity generally includes specific monitored tests undertaken as part
of a planned program of activity.
    There is also an exemption from reporting for TSCA section 8(a)
rules for small manufacturers and processors. For purposes of this rule
EPA is defining and exempting any small manufacturer or processor as a
company that has sales of less than $11 million per year.
    4. Other exceptions to reporting. The rule does not require
manufacturers or processors to report certain information that has
already been submitted to EPA. A person who submitted a notice under
TSCA section 5 to EPA for a reportable chemical substance on or after
January 1, 2005 is not required to report regarding the same substance
under this rule, except where the person manufactured or processed a
new discrete form of the reportable chemical substance. In addition,
any person who has already reported part of or all of the information
that is required under this rule for EPA's Nanoscale Materials
Stewardship Program (NMSP) would not need to report that information
again under this rule. If, however,

information required by this rule was not reported under the NMSP
(including information for each discrete form of a reportable chemical
substance), then reporting of that information would be required under
this rule. The purpose of these exemptions is to avoid duplicative
reporting. For example, new chemical notices under TSCA section 5 that
have been reviewed by EPA as nanoscale materials are not subject to
reporting for the discrete form of a reportable chemical substance that
was submitted and reviewed.

B. When will reporting be required?

    Persons who manufacture or process a discrete form of a reportable
chemical substance at any time during the three years prior to the
final effective date of this rule must report to EPA one year after the
final effective date of the rule. There is also a standing one-time
reporting requirement for persons who intend to manufacture or process
a discrete form of a reportable chemical substance on or after the
effective date of the rule. These persons must report to EPA at least
135 days before manufacture or processing of that discrete form except
where the person has not formed an intent to manufacture or process a
discrete form of a reportable chemical substance 135 days before such
manufacturing or processing, in which case the information must be
filed within 30 days of the formation of such an intent. For example,
if a person forms the intent on July 1 to manufacture a reportable
chemical substance and intends to commence manufacture of the substance
in less than 135 days, that person must report the required information
as to the chemical substance no more than 30 days after forming the
intent, which would be July 31.

C. What information must be reported?

    This rule requires one-time reporting of certain information,
including specific chemical identity, actual or anticipated production
volume, methods of manufacture and processing, use, exposure and
release information, and available health and safety information.
    EPA developed a form (Ref. 8) for reporting information including
specific chemical identity, material characterization, physical
chemical properties, production volume, use, methods of manufacturing
and processing, exposure and release information, and existing
information concerning environmental and health effects. Any person
required to report under this rule must supply the information
identified in the form to the extent it is known to or reasonably
ascertainable by them. EPA intends to issue guidance for the final rule
within six months of issuing the rule including guidance on the
reasonably ascertainable standard, consolidating submissions and
generic chemical names.

D. How will information be submitted to EPA?

    The rule requires electronic reporting similar to the requirements
established in 2013 for submitting other information under TSCA (see
704.20(e)). Submitters will use EPA's CDX, the Agency's electronic
reporting portal, for all reporting under this rule. 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.
9) The final rule follows two previous rules requiring similar
electronic reporting of information submitted to EPA for TSCA Chemical
Data Reporting and for Pre-Manufacture Notices. EPA expects that
electronic reporting will save time, improve data quality and increase
efficiencies for both the submitters and the Agency.
    EPA developed the Chemical Information Submission System (CISS) for
use in submitting data for TSCA sections 4, 8(a), and 8(d)
electronically to the Agency. The web reporting tool is available for
use with Windows, iOS, Linux, and UNIX based computers, using
``Extensible Markup Language'' (XML) specifications for efficient data
transmission across the Internet. CISS, a web-based reporting tool,
provides user-friendly navigation, works with CDX to secure online
communication, creates a completed document in Portable Document Format
(PDF) for review prior to submission, and enables data, reports, and
other information to be submitted easily as PDF attachments, or by
other electronic standards, such as XML.
    EPA is requiring submitters to follow the same submission
procedures used for other TSCA submissions, i.e., to register with
EPA's CDX (if not already registered) and use CISS to prepare a data
file for submission. Registration enables CDX to authenticate identity
and verify authorization. To submit electronically to EPA via CDX,
individuals must first register with that system at http://cdx.epa.gov/epa_home.asp. To register in CDX, 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, selects a user name and password, and
follows the procedures outlined in the guidance document for CDX
available at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf.
    Users who have previously registered with CDX for other TSCA
submissions, Chemical Data Reporting, or the Toxics Release Inventory
TRI-ME web reporting flow, can add the ``Submission for Chemical Safety
and Pesticide Program (CSPP)'' CDX flow to their current registration,
and use the CISS web-based reporting tool.
    All submitters must use CISS to prepare their submissions. CISS
guides users through the process of creating an electronic submission.
Once a user completes the relevant data fields, attaches appropriate
PDF files, or other file types, such as XML files, and completes
metadata information, CISS validates the submission by performing a
basic error check and makes sure all the required fields and
attachments are provided and complete. Further instructions on
submitting and instructions for uploading PDF attachments or other file
types, such as XML, and completing metadata information are available
through CISS reporting guidance.
    CISS allows the user to choose ``Print,'' ``Save,'' or ``Transmit
through CDX.'' When ``Transmit through CDX'' is selected, the user is
asked to provide the user name and password that was created during the
CDX registration process. CISS then encrypts the file and submits it
via CDX. The user will log in to the application and check the status
of their submissions. Upon successful receipt of the submission by EPA,
the status of the submissions will be flagged as ``Completed.'' The CDX
inbox is currently used to notify the users of any correspondence
related to user registration. Information on accessing the CDX user
inbox is provided in the guidance document for CDX at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf. To access CISS
go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx
and follow the appropriate links and for further instructions to go
http://www.epa.gov/oppt/chemtest/ereporting/index.html. Procedures for
reporting chemical substances under this rule are similar.
    Any person submitting a reporting form could claim any of the
information on the form as CBI. Any information which is claimed as
confidential will be disclosed by EPA only to the extent and by the
means of the procedures set forth in 40 CFR part 2.

D. Confidentiality and the Recent Revisions to TSCA

    The Frank R. Lautenberg Chemical Safety for the 21st Century Act
was signed into law on June 22, 2016, and became immediately effective.
This final rule contains one minor change to reflect the new statutory
requirements for asserting confidentiality claims. Section 14(c)(1)(B)
of the law now requires a supporting statement for confidentiality
claims. This statement is similar to the certification currently
required in 40 CFR 704.7, which is cross-referenced in the proposed
rule. In this final rule, EPA is substituting the wording of the
section 14(c)(1)(B) statement for the wording of the certification in
Sec.  704.7(d) so as to eliminate any possibility of doubt that the
certification meets the statutory requirements. While this change was
not discussed in the proposed rule, EPA finds there is good cause to
make this change without notice and comment. Notice and comment are
unnecessary because the new statement is required by statute, and the
new language is sufficiently similar to that in the Sec.  704.7(d)
certification that EPA anticipates no significant effect of the change
on companies reporting under the rule or on the public in general.
    The law also requires that a generic chemical identity be provided
when companies claim a specific chemical identity as confidential. No
conforming change is necessary for this rule, because companies
reporting under this rule will be claiming chemical identities as
confidential only when there is already a generic identity on the
confidential portion of the TSCA Chemical Substances Inventory. CISS
will automatically populate the submission with the generic chemical
name associated with the Inventory listing. This process provides the
greatest degree of structural specificity that is practicable to afford
at the current time. EPA will develop guidance regarding generic names
as required by TSCA, and will determine appropriate procedures
regarding their use and submission.

III. Summary of Response to Comments Including Changes and
Clarifications From the Proposed Rule

    This unit summarizes EPA's responses to comments for several
general areas of comments from multiple stakeholders, and where
responses are particularly relevant to the requirements of the final
rule. EPA also discusses any changes to and clarifications from the
proposed rule. A separate document that summarizes the comments
relevant to the proposal and EPA's responses to those comments has been
prepared and is available in the docket for this rulemaking (Ref. 2).
    Comment 1: Several commenters stated that TSCA applies to chemical
substances, not different physical forms or different particle sizes of
chemical substances, and that discrete forms or discrete physical forms
are not ``chemical substances'' subject to reporting under section 8(a)
of TSCA.
    Response: TSCA section 8(a) authorizes EPA to promulgate rules for
submission of such reports as the Agency ``may reasonably require.''
EPA believes that the information from this reporting will help EPA to
determine whether chemical substances manufactured and processed at the
nanoscale may exhibit behavior relevant to health and safety that is
different from that of non-nanoscale forms of chemical substances. EPA
thus has the authority to require reporting pertaining to different
forms of chemical substances.
    Comment 2: Several commenters stated that the proposed information
requests are outside those allowed by section 8(a) of TSCA. Commenters
specifically identified material characterization including particle
size and morphology, methods of manufacture, weight percent of
impurities, environmental release information, general population,
consumer exposure, risk management practices, and engineering controls.
One commenter wanted EPA to explain more clearly the basis of authority
for requesting information that does not fall within the scope of the
clear statutory authority of TSCA section 8(a).
    Response: Section 8(a) gives EPA broad authority to collect
information that the Administrator may reasonably require. Section
8(a)(1) authorizes EPA to require reporting of such information with
respect to chemical substances as the Administrator may reasonably
require. Although it contains limitations with respect to requirements
to report with mixtures and to chemical substances manufactured in
small quantities for experimentation, those limitations are not
relevant to the requirements imposed by this rulemaking. Section
8(a)(2) is best interpreted as listing examples of the kinds of
information EPA can require reporting on under section 8(a)(1), not as
limiting EPA's authority. If Congress had intended to impose
limitations on the kinds of information EPA can collect under section
8(a)(1), it would have added them to the limitations it included in
section 8(a)(1). EPA has always interpreted section 8(a) in this
fashion, see 58 FR 63134 (November 30, 1993)--an interpretation that is
supported by the legislative history of section 8(a), H.R. Conf. Rep.
94-1679, at 80 (1976); S. Rep. No. 94-698, at 22 (1976), H.R. Rep. No.
94-1341, at 42 (1976). Further, the information required under the rule
is consistent with the examples of information discussed in section
8(a)(2). For example, requiring weight percent of impurities is
analogous to byproducts, material characterization including particle
size and morphology is analogous to molecular structure of chemical
substances manufactured and processed at the nanoscale, environmental
release falls under methods of disposal, while methods of manufacture,
risk management practices, engineering controls, general population and
consumer exposure fall under estimates of individuals who would be
exposed.
    Comment 3: Several commenters noted that processors do not know
about the particle size and other characteristics of formulations they
process or use and should not be required to report.
    Response: Reporting of information under TSCA section 8(a) is
required only to the extent the information is known or reasonably
ascertainable, and includes information that the Administrator may
reasonably require. This standard applies both to the extent of an
entity's obligation to determine whether it is required to report, and
to the extent of information any entity is required to report. If
processors do not know about specific physical properties of chemical
substances, they must still take reasonable measures to ascertain the
information that would determine whether they are subject to the rule.
If processors do not know about specific properties such as particle
size and other properties that would allow them to know if they are
processing a chemical substance subject to the rule, it would be within
the reasonably ascertainable standard to ask their suppliers for
information that would enable the processor to determine whether the
supplier is selling them a nanoscale material subject to reporting and
if so provide them with what reportable information they have. Their
supplier is not required to provide any additional information to the
processor but might provide other supporting information, for example,
whether their supplier has reported or intends to report the chemical
substance under this rule. If the supplier provides information
indicating that the substance is not reportable or if the processor
lacks any other means of

reasonably ascertaining whether the substance is reportable, the
processor does not need to perform tests to determine whether the
substance is reportable. Information developed in the normal course of
business or that the processor chooses to develop must also be used.
The processor may want to document the steps they took to determine if
reporting was required. Companies that purchase formulations but do not
change or modify those formulations and only use them are not
considered processors and are not required to report.
    If the information provided by the supplier indicates that
reporting is required, the processor is required to report information
that is known or reasonably ascertainable, which may include
information obtained from the supplier. This would include situations
where the processor may not know the exact chemical identity or some of
its physical properties.
    The obligations imposed by the reasonably ascertainable standard
are discussed more fully in the Chemical Data Reporting final rule, 76
FR 50816, 50829 (August 16, 2011).
    Comment 4: Several commenters also asked EPA if manufacturers and
processors are only required to report available or reasonably
ascertainable information, does this mean they need to develop
information to comply with the rule. Other commenters asked EPA to
clarify if manufacturers and processors need to develop information to
comply with the rule.
    Response: Manufacturers and processors are not required to conduct
testing or develop new information under this rule. However, they are
required to report information that is known or reasonably
ascertainable.
    Comment 5: Many commenters stated the proposal gives too much
discretion to interpret compliance obligations. Commenters suggested
clarifying the definition of unique and novel properties, adopting an
alternative, or not using it at all. One commenter noted that if the
requirement that reportable chemicals exhibit unique and novel
attributes due to particle size is removed from the definition, the
rule would not differentiate genuinely new nanoscale materials from
traditional legacy products in commerce. Several commenters stated
there should be some differentiation between genuinely new nanoscale
materials in commerce and traditional products. Two commenters
supported the proposed definition while one commenter supported a
definition of 1-100 nm and unique or novel characteristics.
    Response: Based on these comments, EPA agrees that what is a
reportable chemical substance should be better defined and clarified.
EPA is finalizing the rule with further explanation of ``unique and
novel properties'' as described in the National Nanotechnology
Initiative's definition. Some nanostructured materials are stronger or
have different magnetic properties compared to other forms or sizes of
the same material. Others are better at conducting heat or electricity.
See http://www.nano.gov. They may become more chemically reactive or
reflect light better or change color as their size or structure is
altered. A property is novel when it is different from the properties
associated with other forms or sizes of the same chemical substance. As
also noted on http://www.nano.gov, when particle sizes of solid matter
in the visible scale are compared to what can be seen in a regular
optical microscope, there is little difference in the properties of the
particles. But when particles are created with dimensions of about 1-
100 nm, the materials' properties can change significantly from those
at larger scales. See also comment 11 and the response for further
clarification on what is considered a reportable chemical substance.
    For purposes of this rule, EPA is defining unique and novel
properties to include an element of intent, meaning that those
properties are the reason why the chemical substance is manufactured in
that form or size. The rule includes a definition of unique and novel
properties in the definitions section of the regulatory text (See Sec.
704.20(a)). Unique and novel properties means any size-dependent
properties that vary from those associated with other forms or sizes of
the same chemical substance, and such properties are a reason that the
chemical substance is manufactured or processed in that form or size.
In order to be reportable it's not sufficient that a chemical substance
contains particles in the size range of 1-100 nm; it must also have a
size-dependent property different from properties at sizes greater than
100 nm and those properties are a reason that the chemical substance is
manufactured or processed in that form or size. Intentionally
manufacturing or processing nanoscale gold so that it exhibits a red or
purple color instead of a yellow color would create a unique or novel
optical property seen at the nanoscale. Such a change would likely
result in changes of other properties, such as specific surface area
which can result in different health and safety impacts. Unique and
novel properties which impact performance generally cannot be isolated
from concurrent changes in properties that impact biological systems.
For example, see the discussion in Unit II.B. of the proposed rule of
the range of biological impacts of nanoscale materials. EPA is
exempting certain biological materials, in part, because they do not
exhibit different size-dependent properties in the size range of 1-100
nm.
    Other chemical substances, including as an example some chemicals
that commenters proposed that EPA exempt from reporting, such as
pigments, polymers, and polymer dispersions, could be manufactured in
nanoscale forms that both exhibit unique and novel properties and in
forms that do not. In the concept paper for the NMSP (Ref. 10), EPA
stated that many polymers or oligomers, particularly linear or planar
polymers, should not be reported even though they have dimensions in
the nanoscale. Those polymers did not demonstrate size-dependent
properties. The paper did note that when conditions of polymerization
or post-reaction processing create free particles that fit the general
description of ``engineered nanoscale material'' those chemical
substances should be reported under the NMSP. Please also refer to the
comment and response to comment 12 in the response to comments document
regarding the difference between enhanced and novel properties.
    Comment 6: Several commenters suggested alternative definitions of
trace amounts stating that the term in the proposed rule is not
definitive and gives too much discretion to interpret compliance
obligations. The commenters suggested including a numerical value to
define trace amount. Most commenters did not suggest a specific value,
although one commenter noted the original definition of the Agency's
draft proposed rule submitted to OMB would have required reporting for
those substances containing =10% particles in the range of
1-100 nm while another commenter suggested using a numerical value of
less than 10% of particles as trace amount that would not be considered
to be a reportable chemical substance. Commenters asked EPA to clarify
if particle size was to be determined by weight, volume, or count. One
commenter stated that EPA should not use weight based criteria to
determine particle size as that measurement is sometimes skewed by the
inclusion of very large particles. Several other commenters suggested
using weight based criteria to identify particle size but did not give
any reasons why.

    Response: Chemical substances manufactured or processed at the
nanoscale that contain incidental amounts of particles in the size
range of 1-100 nm are not reportable chemical substances. EPA used
trace amounts in the proposed rule to define this concept. However,
based on the public comments to more clearly define trace amounts
including several comments to establish a numerical cutoff, EPA is
instead using a numerical value of less than 1% of particles from 1-100
nm by weight to more clearly define those chemical substances that
would not be reportable. EPA has chosen this number because it is the
percentage cut-off used in OSHA's hazard communication standard for all
chemicals substances that are not OSHA carcinogens (for which there is
a 0.1% cut-off) (Ref. 11). This 1% cut-off is a level that industry has
used to identify chemicals in safety data sheets (and previously in
material safety data sheets.) Industry is already using this cut-off to
identify at least some nanoscale chemical substances, e.g., carbon
nanotubes in mixtures. EPA is using the weight based method for
measuring particles even though that measurement is sometimes altered
by the presence of very large particles because it is the most widely
used method, and more data will therefore be available. The final rule
does not require reporting for any chemical substance where less than
1% percent of the particle size distribution by weight is less than 100
nm.
    Changes to the Definition of a Reportable Chemical Substance in the
Final Rule. EPA has added a definition of unique and novel properties
in the definitions section of the regulatory text (See 704.20(a)).
Unique and novel properties means any size-dependent property that vary
from other properties associated with other forms or sizes of the same
chemical substance, and such properties are the reason that the
chemical substance is manufactured or processed in that form or size. A
reportable chemical substance is not just a substance containing
particles in the size range of 1-100 nm; it must also have a size-
dependent property different from properties at sizes greater than 100
nm. The final rule no longer states that a reportable chemical
substance does not include a chemical substance that only has trace
amounts of primary particles, aggregates, or agglomerates in the size
range of 1-100 nm, such that the chemical substance does not exhibit
the unique and novel characteristics or properties because of particle
size. The final rule now states that a reportable chemical substance
does not include a chemical substance that is manufactured or processed
in a form where less than 1% of any particles, including aggregates and
agglomerates, measured by weight are in the size range of 1-100 nm.
    Comment 7: A variety of commenters stated that EPA should add
additional exemptions for biological materials such as enzymes, lipids,
carbohydrates, peptides, polypeptides, nucleotides, liposomes,
antibodies, viruses, virus-like particles, viral based products,
organelles, and microorganisms. The commenters stated that the
additional biological materials should be exempted for the same reason
EPA proposed to exempt DNA, RNA, and proteins, that the additional
biological materials did not exhibit properties as a function of their
size range.
    Response: Because they meet the same criteria that EPA identified
in the proposed rule, EPA is adding an exemption for enzymes, lipids,
carbohydrates, peptides, liposomes, antibodies, viruses, and
microorganisms in the final rule. The properties of all the exempted
biological materials, which can be in the nanoscale, are not a function
of the size range per se but rather of the precise nucleotide sequence
(in the case of DNA and RNA), shape, and complex biological structures
(living cells).
    Comment 8: Several commenters identified additional possible
exemptions for organic and inorganic pigments and dyes; polymers
including polymer dispersions; and chemical substances used in
adhesives, coatings and sealants and chemical substances when they are
embedded in a polymer matrix or incorporated into a formulated product
such as adhesives, cement, ink, coatings, glass, paint, plastic and
rubber because they are well understood or characterized and present
low risk and low potential for exposure. Commenters suggested that EPA
include an exemption for polymers and polymer dispersions to be
consistent with the polymer exemption under section 5 of TSCA.
Commenters also noted TSCA section 5 regulations such as SNURs which
exempted requirements for carbon nanotubes, silica, and pigments when
incorporated into polymer matrices.
    Response: A reportable chemical substance is not just a substance
containing particles in the size range of 1-100 nm; it must also have a
size-dependent property different from properties at sizes greater than
100 nm. The chemical substances or activities identified by commenters
could be manufactured in nanoscale forms that both exhibit unique and
novel properties and in forms that do not. If a chemical substance does
not exhibit unique and novel properties, then no reporting would be
required. EPA lacks information demonstrating minimal risk and exposure
for nanoscale forms of the chemical substances or activities that
commenters proposed for exemption. The polymer exemption under TSCA
section 5 is not based on any consideration of the potential for
impacts from polymers with size dependent properties and does not
include all polymers. Most of the activities described by commenters
for exemption would only require reporting for a reportable chemical
substance before it is incorporated into a formulated product or
polymer matrix. Reporting would not be required by persons who use the
formulated product or polymer matrix. EPA is not including an exemption
for these chemical substances and activities because doing so would
exempt some of the nanoscale materials in commerce for which EPA is
collecting information on health and safety effects which would allow
EPA to better assess and manage risks of nanoscale materials.
    Comment 9: Several commenters proposed limited or no reporting for
nanoscale materials such as carbon black, silica, titanium dioxide,
nanosilver, and nanocellulose, based on the proposed exemption for
nanoclays and zinc oxide. The commenters asked EPA to better define the
criteria it used to exempt nanoclays and zinc oxide as well-
characterized so that the criteria could be applied to these chemical
substances. One commenter noted that available information for
commercial forms of nanocellulose demonstrate low hazard and risk.
Several commenters also described the hazards and exposures of these
chemical substances as well-characterized. Several commenters stated
that EPA should not exempt zinc oxide and nanoclays as EPA had not
identified and made available the data that demonstrated why they are
well-characterized.
    Response: EPA has decided to not exempt nanoclays and zinc oxide
from reporting. When considering the comments to exempt other chemical
substances based on its proposed exemption for zinc oxide and
nanoclays, EPA realized that it had given too much weight to the
available information on zinc oxide and nanoclays. While there is some
available information on these chemical substances, EPA does not
consider the available information sufficient to extrapolate to all
other forms of these chemical substances to exclude information
collection under TSCA. Further, this limited information

is not a sufficient basis to create a broader exemption by analogy for
other chemical substances. Thus, even for chemical substances
manufactured as nanoscale materials that could be described as a group
as well-characterized or demonstrating low hazard based on data not
relating to nanoscale forms in particular, EPA lacks information on how
much and what type of specific nanoscale materials are in commerce and
what kind of information is available to assess the properties that can
impact health and safety and thus potential risks of those nanoscale
materials. The chemical substances that commenters and EPA stated were
well characterized could be manufactured in nanoscale forms that both
exhibit unique and novel properties and in forms that do not. EPA is
not exempting from reporting any of the chemical substances proposed by
commenters, including zinc oxide and nanoclays because doing so would
exempt some of the nanoscale materials in commerce for which EPA is
collecting information on health and safety effects which would allow
EPA to better assess and manage risks of nanoscale materials. The type
of information described by the commenter regarding nanocellulose is
the type of information on health and safety effects which would allow
EPA to better assess and manage risks of nanoscale materials.
    Changes to Chemical Substances That are Exempt from the Final Rule:
EPA added exemptions for enzymes, lipids, carbohydrates, peptides,
liposomes, antibodies, viruses, microorganisms in the final rule. EPA
did not add any other exemptions to the final rule. EPA did not include
the proposed exemptions for nanoclays and zinc oxide in the final rule.
    Comment 10: Several commenters stated that EPA cannot require
information that violates the language under TSCA section 8(a)
prohibiting ``any reporting which is unnecessary or duplicative.''
Commenters stated that requiring reporting of some of the information
already reported to the NMSP would be duplicative, especially the large
amount of health and safety information submitted for broad classes of
chemical substances such as silica and carbon black. Commenters also
asked EPA to explain why the proposed reporting requirements do not
duplicate reporting required under CDR.
    Response: The reporting required by this rule does not duplicate
reporting EPA would receive under other TSCA regulations. Chemical data
reporting (CDR) under 40 CFR part 711 does not require manufacturers to
distinguish reporting for different forms of chemical substances
including nanoscale materials. This rule also exempts reporting for
chemical substances that are nanoscale materials that have already been
reported under section 5 of TSCA since 2005 except for new discrete
forms. As noted in the interim report on the NMSP (Ref. 12), EPA
received limited reporting on nanoscale materials in commerce. The
reporting for nanoscale materials such as silica and carbon black gave
an overview of the entire industry but not information on individual
nanoscale materials. A company reporting a silica or carbon black-based
nanoscale material does not have to resubmit the information submitted
under the NMSP. However, any reporting of silica or carbon black
nanoscale materials would need to include any health and safety
information that company possesses for the specific nanoscale material
it is reporting. As already noted, CDR reporting does not distinguish
between different nanoscale forms of chemical substances. Several
commenters stated that EPA needs more information on nanoscale
materials in commerce. In the full response to comments document, EPA
addresses more specific comments about information required by the
rule.
    Comment 11: There were numerous comments to not include the 135 day
reporting requirement for new discrete forms. This requirement was
characterized by several commenters as de facto new chemical reporting.
Commenters also asked EPA to clarify if persons subject to the rule had
to wait until the 135 day period was completed before commencing
manufacture or processing. The 135 day reporting requirement was
supported by several commenters because it provides the Agency with
more time to identify potential concerns and initiate appropriate
action to address them.
    Response: EPA did not intend to create de facto new chemical
reporting for new discrete forms of nanoscale materials, because the
135-day period is not a formal review-period that prohibits manufacture
before the end of the 135-day period. Rather, based on EPA's experience
with the Premanufacture Notice (PMN) program, EPA believes that in most
cases companies have the requisite intent to manufacture or process at
least 135 days before manufacturing or processing will begin, and the
rule requires reporting based upon this presumed intent. However, if a
company does not form the requisite intent 135 days ahead of time, the
company must report within 30 days of the formation of such an intent.
Moreover, if a company desires to begin manufacture or processing less
than 135 days after the submission for this rule is made, the company
is free to do so. There is no obligation upon the company to wait 135
days after reporting to manufacture or process. EPA is revising the
language in 704.20(f)(2) to clarify that the rule does not prevent
manufacturing before the 135-day period has passed. If the company
changes its schedule or does not form the intent until a later time, it
may wish to document supporting facts.
    Further, the comments made EPA realize that the regulatory text as
written in the proposal created a result unintended by the Agency (and
not commented upon): Because (1) the default period of 135 days is
greater than the advance of periods required for various section 5
submissions, and (2) the reporting exemption for section 5 submissions
in 704.20(c)(2) of the proposal would apply only where the company had
already filed a section 5 submission, a company proposing to
manufacture a discrete form of a reportable substance for which a
section 5 submission had not been filed might conceivably be required
to first file a section 8(a) report, followed by a section 5
submission. In such cases EPA only needs the section 5 submission and
exercise whatever section 5 authority might be necessary in a specific
case, rather than imposing an additional burden of requiring a
duplicative section 8(a) submission. Therefore EPA is adding a new
subcategory of non-reportable chemical substances to 704.20(c)(1), for
chemical substances that are not on the TSCA Inventory at the time
reporting would otherwise be required, to clarify the Agency's original
intent in the NPRM. If a reportable chemical substance is not on the
TSCA Inventory a manufacturer only needs to submit a new chemical
notification under section 5 of TSCA.
    Changes to the 135-day Reporting Requirement for Discrete Forms of
a Reportable Chemical Substance: EPA has added language to 40 CFR part
704.20(f)(2): ``except where the person has not formed an intent to
manufacture or process that discrete form at least 135 days before
commencing such manufacture or processing, in which case the
information must be filed within 30 days of the formation of such an
intent.'' The language makes clear what companies must do if they do
form an intent to manufacture or process a discrete form of a
reportable chemical substance less than 135 days ahead of manufacture
or processing.
    Changes to Chemical Substances That Are Not Reportable: EPA has
added language to 704.20(c)(1), exempting

chemical substances that are not on the TSCA Inventory from reporting.
    Comment 12: There is not standardized testing for the physical
properties in the proposed rule identified for manufacturers and
processors to determine if they qualify for the rule. EPA should
identify test methods to be used to comply with the rule. Many
processors will not know to test for these properties. EPA cannot
require this testing until validated protocols are developed.
    Response: Testing or developing new information is not required by
the rule. Only known or reasonably ascertainable information needs to
be reported. Companies are only required to report on known or
reasonably ascertainable information. See the response to comment 3 for
guidance as to situations in which a company does not know about the
physical properties identified in the regulation. In the proposed rule,
EPA supplied examples of testing guidelines that could be used for
these types of properties should the company desire to do such testing.
    Comment 13: Several commenters supported the $4 million dollar
small business exemption. One commenter wanted an even smaller dollar
amount so that more small businesses would be required to report. Other
commenters supported just using the dollar amount but stated it should
be increased to $9.5 million dollars to account for inflation since
1988 when the current small business amount of $4 million was
established.
    Response: Based on these comments and updated economic information,
EPA is changing the definition of small business in the final rule to
include any company with sales of $11 million dollars or less. In
suggesting EPA change the value to $9.5 million, the commenter assumed
the original $4 million was promulgated in 1988. However, the $4
million was initially promulgated in 1984 (49 FR 45425) with a base
year of 1983. Therefore, it is appropriate to inflate the $4 million
from $1983 to $2015. When accounting for inflation since 1983, EPA
calculated the figure to be $11 million dollars.
    In proposing this definition, EPA provided notice and comment on
the criteria for small manufacturers and processors subject to this
rule, and consulted with the Small Business Administration (SBA) in
accordance with TSCA section 8(a)(3)(B). EPA's change to this
definition is consistent with both public comments and the feedback we
received from SBA.
    EPA recognizes that recent amendments to TSCA include a new and
separate obligation under amended TSCA section 8(a)(3)(C), which
requires EPA, after consultation with the SBA, to review the adequacy
of the standards for determining the manufacturers and processors which
qualify as small manufacturers and processors for purposes of TSCA
sections 8(a)(1) and 8(a)(3). TSCA furthermore requires that (after
consulting with the SBA and providing public notice and an opportunity
for comment) EPA make a determination as to whether revision of the
standards is warranted. In the Federal Register of December 15, 2016
(81 FR 90840) (FRL-9956-03), EPA sought public comment on whether a
revision of the current size standard definitions is warranted at this
time; announced EPA's initiation of the required consultation with the
SBA, and provided its preliminary determination that revision to the
currently codified size standards for TSCA section 8(a) is indeed
warranted. As part of this effort, EPA will review the adequacy of the
standards for small manufacturers and processors in existing TSCA
section 8(a) rules, including this one. Any changes resulting from the
assessment will undergo consultation with SBA and will be proposed for
notice and comment as required by TSCA section 8(a)(3)(C).
    Changes to the Definition of a Small Manufacturer or Processor
Exempt from the Reporting Requirements of the Rule: The final rule
retains a small business exemption based only on sales, but a small
manufacturer or processor will be defined as any company with sales of
less than $11 million per year.
    Comment 14: Several commenters asked EPA to clarify the objects and
collections of objects to which the 1-100 nm measurement applies. In
other words, does that mean any form with particles 1-100 nm or does
that include aggregates and agglomerates greater than 100 nm but based
on primary particles less than 100 nm?
    Response: Chemical substances required to be reported would include
any form with particles 1-100 nm but would not include aggregates or
agglomerates greater than 100 nm even if they contain primary particles
less than 100 nm. EPA has modified the description of particles that
would be subject to reporting in the definition of reportable chemical
substance to better reflect this understanding. The language in the
reportable chemical substance definition now reads, ``where any
particles, including aggregates and agglomerates, are in the size range
of 1-100 nm''
    Comment 15: Several commenters suggested that EPA should better
define particle. One commenter stated ``The word `particle' is not a
term with specific meaning. It is critical that EPA is clear about the
definition of `particle' so that companies understand what materials
require reporting. For example, does the term `particle' include solid
objects that contain internal crystalline domains at the nanoscale?
Does it include dispersions, suspensions, or aerosols? A definition of
`particle' would provide an important starting point for determining
whether a material is subject to reporting. It should take into account
the ability of a `particle' to move freely in its environment.''
    Response: EPA will use the definition of particle from ISO, which
is a ``minute piece of matter with defined physical boundaries.'' The
notes to the ISO definition should be used as guidance in applying this
definition. Note 1: A physical boundary can also be described as an
interface. Note 2: A particle can move as a unit. EPA is using this
definition because there is international agreement on the definition;
the definition addresses the commenter's questions about the ability of
a particle to move in the environment and whether ``particle'' includes
dispersions, suspensions, or aerosols.
    Changes to the Final Rule to Clarify the Types of Particles to be
Measured: EPA has added a definition of particle and modified the
language in the definition of reportable chemical substance for the
types of particles that will be measured.
    Comment 16: Several commenters stated that the shape criteria for
identifying reportable chemical substances are too vague and
unworkable. The commenters asked what the criteria are to discern one
shape from another. For example one commenter stated ``For morphology,
how would manufacturers and processors distinguish between the
different morphologies identified in the proposed regulatory text: What
definitions would distinguish for example a rod from an ellipsoid,
needle, wire, and/or fiber as these shapes could be considered on a
continuum? Another commenter stated ``It is unclear how different the
shapes of two forms would have to be in order to trigger the discrete
forms requirement.''
    Response: As noted in the proposed rule the different morphology
could be any change in the shape of particles. Different morphology
does not include random shape changes or natural variation in shapes of
particles that are not definitive and that, as commenters have noted,
occur in a continuum. Some nanoscale materials are engineered to give
all the particles a certain morphology or shape. The change in

shape needs to be a specifically engineered change in the shape of
particles of a nanoscale material, to effect a change and form a unique
and novel property for a chemical substance in the particle size range
of 1-100 nm.
    Comment 17: Several commenters objected to imposing the same
reporting requirements on both processors and manufacturers stating
that some processors will not be aware of information known to
manufacturers such as for example chemical identity, physical-chemical
properties, byproducts, impurities, health effects data, and general
population exposure. In addition, the commenters speculated that
processors may report uses and processes already reported by the
manufacturer. The commenters felt the reporting requirements place
impractical or burdensome obligations on processors without collecting
information that would serve the intended purposes of the rule when
manufacturers were in the best position to report information required
by the rule. Commenters suggested limiting reporting to only
manufacturers or limiting the information to be reported by processors.
    Response: Processors are only required to submit information that
is known or reasonably ascertainable. In addition, processors may have
access to pertinent information that manufacturers do not have access
to. Processors can often describe in greater detail how the nanoscale
material is processed and used and any characteristics that change
because of processing. Details on the processing and use of nanoscale
forms of chemical substances with unique or novel properties will give
EPA a better understanding regarding how to assess those chemical
substances and whether any further actions are warranted under TSCA.
    Comment 18: Several commenters stated that EPA should exempt
naturally occurring or mined nanoscale materials. One commenter noted
that CDR regulations exempt naturally occurring chemical substances as
described at 40 CFR 710.4(b). Several commenters also stated naturally
occurring nanoscale materials should be exempt from reporting as they
do not meet the criteria of the definition of ``manufactured or
processed.'' Another commenter suggested limiting reporting to
engineered nanomaterials as they are ``generated for a specific
function'' or ``deliberately manipulated.''
    Response: EPA did not exempt naturally occurring materials or limit
reporting to chemical substances engineered at the nanoscale because
some of these chemical substances meet the criteria of a reportable
chemical substance and some of them do not. These chemical substances
must be reported only if they meet the definition of containing
particles in the size range of 1-100 nanometers and a size-dependent
property different from properties at sizes greater than 100
nanometers. EPA expects that reportable chemical substances would
usually be the result of processing of naturally occurring or mined
materials by manufacturers and processors
    Comment 19: A commenter stated that EPA should add an explicit
exemption for nanoscale substances that are unintentionally generated
during manufacturing and processing. Another commenter asked EPA to
clarify if it matters if a nanoscale substance is intentionally added
versus accidentally formed.
    Response: If a nanoscale chemical substance is unintentionally
generated or added and not intended to be part of the commercially
manufactured or processed chemical substance, it may be considered a
byproduct or impurity and would be exempt under 40 CFR 704.5(b) or (c).
If a nanoscale chemical substance is unintentionally formed but is
considered to be part of the function of the commercial product, it
would be a reportable chemical substance. A chemical substance which is
intentionally produced but is in total or in part unintentionally
produced at the nanoscale is not an impurity or a byproduct. There are
examples where a chemical substance is intentionally produced, but
unintentionally produced at the nanoscale, and the manufacturer knows
that it contributes to the function of their product. In those cases,
where a company knows about its functionality, the chemical substance
is still subject to TSCA reporting requirements. See, for example,
EPA's PMN regulations at 40 CFR 720.30(h)(2), which exempts from
reporting a byproduct not used for commercial purposes, but retains the
reporting requirement if the byproduct is used for commercial purposes.
The rule does not require a company to determine the functionality of
every impurity or byproduct. A company is required to report that
chemical substance when it knows the chemical substance has commercial
functionality.
    Other Changes to the Final Rule: EPA made other changes to the
rule. See the Response to Comments Document (Ref. 2) for further
details. EPA has modified the definition of zeta potential to address
public comments that zeta potential was not accurately defined in the
proposed rule. Because ``chemical substances manufactured at the
nanoscale as part of a film on a surface'' did not adequately describe
the films on a surface exemption that was proposed, EPA changed the
wording of the exemption to state ``chemical substances formed at the
nanoscale as part of a film on a surface.''
    Changes to the Reporting Form: EPA made the following changes to
the reporting form. See the Response to Comments Document (Ref. 2) for
further explanation. EPA removed the requirement for an overview of the
life cycle in Section C of the reporting form, as that information
duplicates information already identified in other parts of the form.
Because not all enhanced properties are unique or novel properties, EPA
replaced the word enhanced with novel in section C.5. of the reporting
form. EPA added language to the form instructions that ``You may want
to consult with your customers or suppliers about the confidentiality
of any information you report about them on this form'' in response to
comments that manufacturers or processors may not accurately identify
confidential information obtained from suppliers or customers. In order
to help facilitate continued work on sharing available information and
to inform future alignment on activities pertaining to nanoscale
materials, EPA included the option on the reporting form to share
information with Environment and Climate Change Canada and Health
Canada per one commenter's request to provide the option of sharing
CBI.

IV. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    1. EPA. Chemical Substances When Manufactured or Processed as
Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements;
Proposed Rule. Federal Register April 6, 2015 (80 FR 18330) (FRL-
9920-90).
    2. 2016. EPA. Response to Comments to the Proposed Rule,
Chemical Substances When Manufactured or Processed as Nanoscale
Materials; TSCA Reporting and Recordkeeping Requirements; RIN 2070-
AJ54. Docket # EPA-HQ-OPPT-2010-0572.
    3. 2011. Executive Office of the President. Policy Principles
for the U.S. Decision-Making Concerning Regulation and Oversight

of Applications of Nanotechnology and Nanomaterials. https://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf, and
Principles for Regulation and Oversight of Emerging Technologies at
https://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/Principles-for-Regulation-and-Oversight-of-Emerging-Technologies-new.pdf.
    4. 2016. EPA. Economic Analysis for the TSCA Section 8(a)
Reporting Requirements for Certain Nanoscale Materials (RIN 2070-
AJ54). December 2016.
    5. 2012. International Organization for Standardization (ISO).
Nanotechnologies--Guidance on Physicochemical Characterization for
Manufactured Nano-objects Submitted for Toxicological Testing. ISO/
TR (Technical Report) ISO/TR 13014:2012.
    6. 1999. Colloidal Dynamics. The Zeta Potential. http://www.colloidal-dynamics.com/docs/CDElTut1.pdf.
    7. 2013. ISO/TR. Guidelines for Characterization of Dispersion
Stability. ISO/TR 13097:2013.
    8. 2016. EPA. Information Submission Form. TSCA section 8(a)
Information Reporting for Nanoscale Materials. EPA Form No. 7710-
[tbd]; EPA ICR No. 2517.02; OMB Control No. 2070--NEW.
    9. 2013. EPA. Electronic Reporting Under the Toxic Substances
Control Act; Final Rule. Federal Register (78 FR 72818, December 4,
2013) (FRL 9394-6).
    10. 2007. EPA. Nanoscale Materials Stewardship Program--Concept
Paper.
    11. OSHA. OSHA Hazard Communication Standard; 29 CFR part
1910.1200, https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099.
    12. 2009. EPA. Interim Report on the Nanoscale Materials
Stewardship Program.
    13. 2015. EPA. Chemical-Specific Rules, Toxic Substances Control
Act Section 8(a). OMB control No. 2070-0067 (EPA ICR No. 1198.10).
    14. 2015. EPA. Addendum to an Existing EPA ICR Entitled:
Chemical-Specific Rules, Toxic Substances Control Act Section 8(a).
EPA ICR No. 2157.02; OMB Control No. 2070--[new].

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://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 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), and any changes made in response to OMB
recommendations are documented in the docket. EPA prepared an economic
analysis for this action (Ref. 4), which is available in the docket and
discussed in Unit I.E.

B. Paperwork Reduction Act (PRA)

    The information collection activities in 40 CFR part 704 related to
TSCA section 8(a) reporting rules are approved by OMB under the PRA and
assigned OMB control No. 2070-0067 (EPA ICR No. 1198) (Ref. 13).
Because this rule revises those information collection activities and
the related collection instrument, additional approval by OMB is
required. As such, EPA has prepared an addendum to the currently
approved ICR; the addendum is identified under EPA ICR No. 2517.02 (OMB
Control No. 2070--[new]) (Ref. 14). The ICR document provides the
estimated burden and costs for the information collection activities
contained in this final rule. You can find a copy of the ICR in the
docket for this rule, and it is briefly summarized here. The
information collection requirements are not enforceable until OMB
approves them.
    Respondents/affected entities: Chemical manufacturers (including
importers) and processors.
    Respondent's obligation to respond: Mandatory.
    Estimated number of respondents: 2,681.
    Frequency of response: Variable.
    Total estimated burden: 146,855 hours (average per year). Burden is
defined at 5 CFR 1320.3(b).
    Total estimated burden cost: $11.33 million (per year), includes $0
annualized capital or operation and maintenance costs.
    Change in approved burden: The total burden in OMB's inventory for
the existing, approved ICR (275 hours), will be increased by 146,855
hours, for a new total burden of 147,130 hours. If an entity were to
submit a report to the Agency, the annual burden is estimated to
average 164 hours per response. Burden is defined in 5 CFR 1320.3(b).
As presented in the economic analyses and the ICR addenda, EPA
estimates that the TSCA section 8(a) rule will create a total
incremental industry burden of 440,566 hours over three years.
    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 the EPA
regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves
this ICR, the Agency will announce that approval in the Federal
Register and publish a technical amendment to 40 CFR part 9 to display
the OMB control number for the approved information collection
activities contained in this final rule.

C. Regulatory Flexibility Act (RFA)

    I certify 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. The small entities
subject to the requirements of this action are small businesses, small
governmental jurisdictions and small non-profits. A small business
exemption exists under TSCA section 8(a) reporting rules, at 40 CFR
704.5(f). For this action, EPA is modifying the exemption. EPA analyzed
potential small business impacts from this rule using both the SBA
employee size standards and the TSCA sales-based definition of small
business. The Agency has determined that up to 411 small businesses may
be impacted and evaluated the number that may incur costs at below 1%
and 3%, and above 3% of sales. EPA estimates that all 411 small
businesses identified will incur costs below 1% of sales, which EPA has
determined is not a significant adverse economic impact on a
substantial number of small entities. Details of this analysis are
presented in the small entity impact analysis that EPA prepared for
this action as part of the Agency's economic analysis that is in the
public docket for this rule (Ref. 4).

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. Based on EPA's
experience with proposing and finalizing rules under TSCA section 8(a),
State, local and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reason to believe that any
State, local or Tribal government will be impacted by this rulemaking.
In addition, this action will not result in annual expenditures of $100
million or more for the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects 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.

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

    This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not 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. Thus, Executive Order 13175 does not apply to this action.

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

    The EPA interprets Executive Order 13045 (62 FR 19885, April 23,
1997) as applying only to those regulatory actions that concern
environmental health or safety risks that the EPA has reason to believe
may disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order. This
action is not subject to Executive Order 13045 because it does not
concern an environmental health or safety risk. Nevertheless, the
information obtained by the reporting required by this rule will be
used to inform the Agency's decision-making process regarding chemical
substances to which children may be disproportionately exposed. This
information will also assist the Agency and others in determining
whether the chemical substances addressed in this rule present
potential risks, allowing the Agency and others to take appropriate
action to investigate and mitigate those 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)

    This action does not involve any technical standards, and is
therefore not subject to considerations under NTTAA section 12(d), 15
U.S.C. 272 note.

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

    This action will not have disproportionately high and adverse human
health or environmental effects on minority or low-income populations
as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
This action does not affect the level of protection provided to human
health or the environment. The information collected under this rule
will, however, assist EPA and others in determining the potential
hazards and risks associated with various chemicals manufactured
processed, and used at the nanoscale. Although not directly impacting
environmental justice-related concerns, this information will enable
the Agency to better assess and protect human health and the
environment, including in low-income and minority communities.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States. This
action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 704

    Environmental protection, Chemicals, Hazardous materials,
Recordkeeping, and Reporting requirements.

    Dated: December 29, 2016.
Louise P. Wise,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.

    Therefore, 40 CFR chapter I is amended as follows:

PART 704--REPORTING AND RECORDKEEPING REQUIREMENTS

0
1. The authority citation for part 704 continues to read as follows:

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

0
2. Add Sec.  704.20 to Subpart B, to read as follows:

Sec.  704.20   Chemical substances manufactured or processed at the
nanoscale.

    (a) Definitions. For purposes of this section the terms below are
defined as follows:
    An agglomerate is a collection of weakly bound particles or
aggregates or mixtures of the two where the resulting external surface
area is similar to the sum of the surface areas of the individual
components.
    An aggregate is a particle comprising strongly bonded or fused
particles where the resulting external surface area may be
significantly smaller than the sum of calculated surface areas of the
individual components.
    Central Data Exchange or CDX means EPA's centralized electronic
submission receiving system.
    CISS tool means the Chemical Information Submission System, EPA's
electronic, web-based reporting tool for the completion and submission
of data, reports, and other information, or its successors.
    Discrete form of a reportable chemical substance differs from
another form of the same reportable chemical substance in one or more
of the following 3 characteristics: (i) The change in the reportable
chemical substance is due to all of the following:
    (A) There is a change in process to effect a change in size, a
change in one or more of the properties of the reportable chemical
substances identified in paragraph (i)(C) of this definition, or both;
    (B) There is a size variation in the mean particle size that is
greater than 7 times the standard deviation of the mean particle size
(+/- 7 times the standard deviation); and
    (C) There is a change in at least one of the following properties:
Zeta potential, specific surface area, dispersion stability, or surface
reactivity, that is greater than 7 times the standard deviation of the
measured value (+/- 7 times the standard deviation).
    (ii) The reportable chemical substance has a different morphology.
Examples of morphologies include but are not limited to sphere, rod,
ellipsoid, cylinder, needle, wire, fiber, cage, hollow shell, tree,
flower, ring, torus, cone, and sheet.
    (iii) A reportable chemical substance that is coated with another
chemical substance or mixture at the end of manufacturing or processing
has a coating that consists of a different chemical substance or
mixture.
    Nanoscale Materials Stewardship Program was a program conducted by
EPA from January 2008 to December 2009 under which some nanoscale
material manufacturers and processors voluntarily provided EPA
available information on engineered nanoscale materials that were
manufactured, processed or used.
    Particle is a minute piece of matter with defined physical
boundaries.
    Primary particles are particles or droplets that form during
manufacture of a chemical substance before aggregation or
agglomerization occurs.

    Reportable chemical substance is a chemical substance as defined in
section 3 of TSCA that is solid at 25 [deg]C and standard atmospheric
pressure, that is manufactured or processed in a form where any
particles, including aggregates and agglomerates, are in the size range
of 1-100 nm in at least one dimension, and that is manufactured or
processed to exhibit unique and novel properties because of its size. A
reportable chemical substance does not include a chemical substance
that is manufactured or processed in a form where less than 1% of any
particles, including aggregates, and agglomerates, measured by weight
are in the size range of 1-100 nm.
    Small manufacturer or processor means any manufacturer or processor
whose total annual sales, when combined with those of its parent
company (if any), are less than $11 million. The definition of small
manufacturer in section 704.3 of this title does not apply to reporting
under this section (40 CFR 704.20).
    Specific surface area means the ratio of the area of the surface of
the reportable chemical substance to its mass or volume. Specific
surface area by mass is the ratio of the area of the surface of a
nanoscale material divided by the mass (m\2\/kg) and the specific
surface area by volume is the area of the surface of the reportable
chemical substance divided by its volume m\2\/m\3\.
    Surface reactivity means the reactivity at the surface of a
reportable chemical substance. It is dependent upon factors such as
redox potential, which is a measure of the tendency of a substance to
lose or acquire electrons, photocatalytic activity, including the
potential to generate free radicals.
    Unique and novel properties means any size-dependent properties
that vary from those associated with other forms or sizes of the same
chemical substance, and such properties are a reason that the chemical
substance is manufactured or processed in that form or size.
    Zeta potential is the electrostatic potential near the particle
surface.
    (b) Persons who must report. (1) Persons who can reasonably
ascertain that they are manufacturers and processors of a discrete form
of a reportable chemical substance during the three years prior to the
final effective date of the rule must report except as provided in
paragraph (c) of this section.
    (2) Persons who can reasonably ascertain that they propose to
manufacture or process a discrete form of a reportable chemical
substance after the final effective date of the rule which was not
reported under paragraph (b)(1) of this section must report except as
provided in paragraph (c) of this section.
    (c) When reporting is not required. (1) The following chemical
substances are not subject to reporting under this section:
    (i) Chemical substances formed at the nanoscale as part of a film
on a surface.
    (ii) DNA.
    (iii) RNA.
    (iv) Proteins.
    (v) Enzymes.
    (vi) Lipids.
    (vii) Carbohydrates.
    (viii) Peptides.
    (ix) Liposomes.
    (x) Antibodies.
    (xi) Viruses.
    (xii) Microorganisms.
    (xiii) Chemical substances which dissociate completely in water to
form ions that are smaller than 1 nanometer.
    (xiv) Chemical substances that are not on the TSCA Chemical
Substance Inventory at the time reporting would otherwise be required
under this section.
    (2) Persons who submitted a notice under 40 CFR parts 720, 721, or
723 for a reportable chemical substance on or after January 1, 2005 are
not required to submit a report for the reportable chemical substance
submitted except where the person manufactures or processes a discrete
form of the reportable chemical substance.
    (3) Section 704.5(a) through (e) apply to reporting under this
section. Small manufacturers and processors as defined in paragraph (a)
of this section are exempt from reporting under this section.
    (4) Persons who submitted some or all of the required information
for a reportable chemical substance as part of the Nanoscale Materials
Stewardship Program are not required to report the information
previously submitted except where the person manufactures or processes
a discrete form of the reportable chemical substance.
    (d) What information to report. The following information must be
reported for each discrete form of a reportable chemical substance to
the extent that it is known to or reasonably ascertainable by the
person reporting:
    (1) The common or trade name, the specific chemical identity
including the correct Chemical Abstracts (CA) Index Name and available
Chemical Abstracts Service (CAS) Registry Number, and the molecular
structure of each chemical substance or mixture. Information must be
reported as specified in Sec.  720.45.
    (2) Material characteristics including particle size, morphology,
and surface modifications.
    (3) Physical/chemical properties.
    (4) The maximum weight percentage of impurities and byproducts
resulting from the manufacture, processing, use, or disposal of each
chemical substance.
    (5)(i) Persons described in paragraph (b)(1) of this section must
report the annual production volume for the previous three years before
the effective date of the final rule and an estimate of the maximum
production volume for any consecutive 12-month period during the next
two years of production after the final effective date of this rule.
    (ii) Persons described in paragraph (b)(2) of this section must
report the estimated maximum 12 month production volume and the
estimated maximum production volume for any consecutive 12 month period
during the first three years of production.
    (iii) Estimates for paragraphs (d)(5)(i) and (ii) of this section
must be on 100% chemical basis of the discrete form of the solid
nanoscale material.
    (6) Use information describing the category of each use by function
and application, estimates of the amount manufactured or processed for
each category of use, and estimates of the percentage in the
formulation for each use.
    (7) Detailed information on methods of manufacturing or processing.
    (8) Exposure information with estimates of the number of
individuals exposed in their places of employment, descriptions and
duration of the occupational tasks that cause such exposure,
descriptions and estimates of any general population or consumer
exposures.
    (9) Release information with estimates of the amounts released,
descriptions and duration of the activities that cause such releases,
and whether releases are directly to the environment or to control
technology.
    (10) Risk management practices describing protective equipment for
individuals, engineering controls, control technologies used, any
hazard warning statement, label, safety data sheet, customer training,
or other information which is provided to any person who is reasonably
likely to be exposed to this substance regarding protective equipment
or practices for the safe handing, transport, use, or disposal of the
substance.
    (11) Existing information concerning the environmental and health
effects.
    (e) How to report. You must use CDX and the CISS tool to complete
and submit the information required under this part to EPA
electronically.
    (1) Reporting form. You must complete EPA Form No. 7710-xx, TSCA

Sec.  8(a) Reporting for Nanoscale Materials: Information Submission
Form.
    (2) Electronic submission. You must submit the required information
to EPA electronically via CDX and using the CISS tool.
    (i) To access the CDX portal, go to https://cdx.epa.gov.
    (ii) The CISS tool is accessible in CDX.
    (f) When to report. (1) Persons specified in paragraph (b)(1) of
this section must report the information specified in paragraph (d) of
this section within one year after the final effective date of the
rule.
    (2) Persons specified in paragraph (b)(2) of this section must
report the information specified in paragraph (d) of this section at
least 135 days before commencing manufacture or processing of a
discrete form of the reportable chemical substance, except where the
person has not formed an intent to manufacture or process that discrete
form at least 135 days before commencing such manufacture or
processing, in which case the information must be filed within 30 days
of the formation of such an intent.
    (g) Recordkeeping. Any person subject to the reporting requirements
of this section is subject to the recordkeeping requirements in Sec.
704.11(a) and (b).
    (h) Confidential business information. (1) Persons submitting a
notice under this rule are subject to the requirements for confidential
business information claims in Sec.  704.7(a) through (c).
    (2) In submitting a claim of confidentiality, a person attests to
the truth of the following four statements concerning all information
which is claimed confidential:
    (i) My company has taken 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.

[FR Doc. 2017-00052 Filed 1-11-17; 8:45 am]
 BILLING CODE 6560-50-P