Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements, 3641-3655 [2017-00052]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 82, Number 8 (Thursday, January 12, 2017)]
[Rules and Regulations]
[Pages 3641-3655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00052]


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

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.

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

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

[[Page 3642]]

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 https://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 (202) 566-1744, and the telephone number for the 
OPPT Docket is (202) 566-0280. Please review the visitor instructions 
and additional information about the docket available at https://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: alwood.jim@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. 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

[[Page 3643]]

under the rule available in ChemView (see https://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

[[Page 3644]]

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,

[[Page 3645]]

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 https://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 https://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 https://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 
https://www.epa.gov/oppt/chemtest/ereporting/. 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.

[[Page 3646]]

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

[[Page 3647]]

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 https://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 https://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.

[[Page 3648]]

    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

[[Page 3649]]

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

[[Page 3650]]

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

[[Page 3651]]

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

[[Page 3652]]

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. https://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 https://www2.epa.gov/laws-regulations/laws-and-executive-orders.

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

    This action is 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.

[[Page 3653]]

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.

[[Page 3654]]

    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

[[Page 3655]]

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