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[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Proposed Rules]
[Pages 18330-18342]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07497]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 704

[EPA-HQ-OPPT-2010-0572; FRL-9920-90]
RIN 2070-AJ54

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing reporting and recordkeeping requirements for 
certain chemical substances when they are manufactured or processed at 
the nanoscale as described in this rule. Specifically, EPA proposes to 
require 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 the specific chemical identity, production volume, methods of 
manufacture and processing, exposure and release information, and 
existing data concerning environmental and health effects. This 
proposal involves one-time reporting for existing nanoscale materials 
and one-time reporting for new discrete nanoscale materials before they 
are manufactured or processed. This information would facilitate EPA's 
evaluation of the materials and a determination of whether further 
action, including additional information collection, is needed. 
Consistent with the President's memorandum for Executive Agencies 
regarding Principles for Regulation and Oversight of Emerging 
Technologies, this proposed rule would 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.

DATES: Comments must be received on or before July 6, 2015.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2010-0572, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at  http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim 
Alwood, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone

[[Page 18331]]

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. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
or process or intend to manufacture or process nanoscale forms of 
certain chemical substances. 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 would not be subject to this action. In 
addition, the discussion in Unit III.A. describes in more detail which 
chemical substances would and would not be subject to reporting under 
the proposed rule. You may also consult 40 CFR 704.3 and 704.5, as well 
as the proposed regulatory text in this document, for further 
information on the applicability of these and other exemptions to this 
proposed 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).
     Research and Development in the Physical, Engineering, and 
Life Sciences (except Biotechnology) (NAICS code 541712).

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

    The Toxic Substances Control 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. EPA is proposing this rule under section 8(a) of TSCA, 15 
U.S.C. 2607(a). See also Unit II.A.

C. What action is the agency taking?

    EPA is proposing reporting and recordkeeping requirements for 
persons that manufacture (including import) or process certain chemical 
substances as described in Unit III.A. Persons who currently 
manufacture or process these chemical substances as discrete nanoscale 
materials would be required to notify EPA of certain information 
described in Unit III.C., including specific chemical identity, 
production volume, methods of manufacture and processing, use, exposure 
and release information, and available health and safety data. EPA is 
also proposing that any persons who intend to begin to manufacture or 
process chemical substances as discrete nanoscale materials after the 
effective date of this rule notify EPA of the same information at least 
135 days before the intended date of commencement of manufacture or 
processing. The TSCA section 8(a) rule proposed here involves one-time 
reporting for existing discrete nanoscale forms of certain chemical 
substances and one-time reporting for new discrete nanoscale forms of 
certain chemical substances before they are manufactured or processed. 
A chemical substance as defined under TSCA section 3(2) does not 
include any food, food additive, drug, cosmetic, medical device, 
pesticide or other excluded materials. Such materials are not be 
subject to this rule.
    Included in this proposal are electronic reporting requirements 
similar to those established in 2013 for other kinds of information: 
EPA is proposing to require submitters to use EPA's Central Data 
Exchange (CDX), the Agency's electronic reporting portal, for all 
reporting under this rule. In the Federal Register of December 4, 2013 
(78 FR 72818) (FRL 9394-6), 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). In proposing to require similar 
electronic reporting under this rule, EPA intends to save time, improve 
data quality and increase efficiencies for both the submitters and the 
Agency (Ref. 1).
    This proposed rule and the discussion of the potential risks do not 
conclude and are not intended to conclude 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, 
EPA would use information gathered through this reporting rule to 
determine if any further action under TSCA, including additional 
information collection, is needed. EPA intends to make conclusions on 
the basis of specific scientific evidence. As with current new chemical 
review of nanomaterials, each chemical substance manufactured at the 
nanoscale will be evaluated on a case-by-case basis and not with the 
presumption of either harm or safety, but rather its evaluation will be 
based on the specific nanoscale chemical substance's own properties. If 
adequate data are not available for the properties of the nanoscale 
chemical substance, EPA will use data on structural analogues. Being 
nanoscale is not itself an indication of, or criterion for, hazard or 
exposure potential. Any potential future restrictions on chemical 
substances manufactured at the nanoscale would be tailored to protect 
against the specific harms identified for individual substances or 
categories. EPA would focus any toxicity concerns or data requirements 
based on available exposure or hazard data for specific nanoscale 
chemical substances. If the information provided indicates low risk, 
EPA would not need to consider further review or regulation of that 
nanoscale chemical substance unless subsequent information raises risk 
concerns. For example during review of new chemical substances that are 
nanoscale materials, EPA typically does not request inhalation toxicity 
data for chemical substances that are manufactured in forms or handled 
by processes where no inhalation exposure occurs.
    EPA is not proposing to publish an inventory of chemical substances 
manufactured at the nanoscale based on the information that would be 
collected pursuant to these proposed TSCA section 8(a) reporting 
requirements. EPA will make non-confidential information reported under 
the proposed rule available in ChemView (see http://www.epa.gov/chemview/).

D. Why is the agency taking this action?

    These reporting and recordkeeping requirements would assist EPA in 
its continuing evaluation of chemical substances manufactured at the 
nanoscale, informed by available scientific, technical and economic 
evidence. This proposed rule is not intended to indicate restrictions 
or conclusions about the risks of chemical substances manufactured at 
the nanoscale in general. Rather, the requirements would facilitate 
EPA's

[[Page 18332]]

evaluation of the materials and its determination of whether any 
further action under TSCA, including additional information collection, 
is needed.
    Consistent with the June 9, 2011 memorandum on the Policy 
Principles for the U.S. Decision-Making Concerning Regulation and 
Oversight of Applications of Nanotechnology and Nanomaterials, this 
proposal is not making any finding about the potential risks of 
nanoscale materials in general or any specific nanoscale materials 
(Ref. 2). These generally applicable principles are relevant to 
promoting a balanced, science-based approach to regulating chemical 
substances manufactured at the nanoscale and other applications of 
nanotechnology in a manner that protects human health, safety, and the 
environment without prejudging new technologies or creating unnecessary 
barriers to trade or hampering innovation. These principles build on 
the foundation provided by current regulatory statutes and do not 
supersede existing legal authorities. In this proposal, EPA's approach 
seeks to support the policy principle to ``[s]eek and develop adequate 
information with respect to the potential effects of nanomaterials on 
human health and the environment and take into account new knowledge 
when it becomes available'' (Ref. 2). As with current new chemical 
reviews of chemical substances manufactured at the nanoscale, each 
nanoscale material would be evaluated on a case-by-case basis and not 
with the 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.

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

    EPA has evaluated the potential costs of establishing the proposed 
reporting and recordkeeping requirements for potential manufacturers 
and processors. This analysis (Ref. 3), which is available in the 
docket, is briefly summarized here.
    Under the proposed rule, industry is conservatively estimated to 
incur a burden of approximately 206,098 hours in the first year and 
22,755 hours in subsequent years, with costs of approximately $13.9 
million and $1.5 million, respectively (see Chapter 3 in Ref. 3), while 
the Agency is expected to use approximately 6,539 hours in the first 
year and 723 hours in subsequent years, with costs of approximately 
$0.51 million and $0.06 million respectively (see Chapter 4 in Ref. 3). 
Discounted over a 10-year period at three and seven percent, total 
annualized costs are estimated to be approximately $2.80 million and 
$3.08 million, respectively. (Ref. 3.)

F. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. Overview of Applicable Authority

    1. TSCA section 8(a) reporting. Section 8(a) of TSCA authorizes EPA 
to promulgate rules which require each person (other than a small 
manufacturer or processor) who manufactures, processes, or proposes to 
manufacture or process a chemical substance, to maintain such records 
and submit such reports as the EPA Administrator may reasonably 
require. TSCA section 8(a) gives EPA authority to determine the format 
of reporting under this section.
    Small manufacturers and processors, as defined by EPA, are exempt 
from TSCA section 8(a) reporting requirements, unless the manufacture 
or processing is subject to a rule proposed or promulgated under TSCA 
sections 4, 5(b)(4), or 6, or an order under section 5(e). Under TSCA 
section 8(a)(3)(B), after consultation with the Administrator of the 
Small Business Administration (SBA), EPA may prescribe standards for 
determining which manufacturers and processors qualify as small for 
purposes of reporting under a TSCA section 8(a) rule.
    General provisions for TSCA section 8(a) rules appear in 40 CFR 
part 704 Subpart A. These provisions describe definitions, exemptions 
(including for articles and research and development), confidential 
business information claims, and recordkeeping that apply to TSCA 
section 8(a) rules. For example in 40 CFR 704.3 the definition of known 
to or reasonably ascertainable by is defined to mean all information in 
a person's possession or control, plus all information that a 
reasonable person similarly situated might be expected to possess, 
control, or know.
    In addition, the definitions in TSCA section 3 apply to this 
rulemaking.
    2. Electronic reporting under the Government Paperwork Elimination 
Act (GPEA). 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's Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR 
part 3) (Ref. 4), provides that any requirement in title 40 of the CFR 
to submit a report directly to EPA can be satisfied with an electronic 
submission that meets certain conditions once the Agency published a 
document in the Federal Register announcing that EPA is prepared to 
receive certain documents in electronic form. For more information 
about CROMERR, go to http://www.epa.gov/cromerr.

B. Why is EPA interested in nanoscale materials?

    There is a growing body of scientific evidence showing the 
differences that exist between chemical substances and chemical 
substances manufactured in nanoscale forms (Ref. 5). Chemical 
substances manufactured at the nanoscale may have different or enhanced 
properties--for example, electrical, chemical, magnetic, mechanical, 
thermal, or optical properties--or features, such as improved hardness 
or strength, that are highly desirable for applications in commercial, 
medical, military, and environmental sectors (Ref. 6). These properties 
are a direct consequence of decreasing size, where surface area per 
unit of volume increases exponentially and quantum effects may appear 
in the low tens of nanometers and below. Small size itself can also be 
a desirable property of nanoscale materials. The small size can be 
exploited for miniaturization of applications/processes and/or 
stabilization or delivery of payloads to diverse environments or 
incorporation into diverse products.
    Nanoscale materials have a range of potentially beneficial public 
and commercial applications, including medicine and public health, 
clean energy, pollution reduction and

[[Page 18333]]

environmental cleanup, and improved products such as stronger, lighter, 
and more durable or conductive materials. These benefits arise from the 
distinctive properties of nanoscale materials, in that they are 
potentially more interactive or durable than other chemical substances. 
Altering the size of a material from conventional particle size can 
enhance or produce unique properties that are desirable for a variety 
of commercial applications. However, these unique and enhanced 
properties can raise new questions, such as whether the material in the 
smaller form may present increased hazards to humans and the 
environment.
    Government, academic, and private sector scientists in multiple 
countries are performing research into the environmental and human 
health effects of diverse nanoscale materials, resulting in a 
substantial and rapidly growing body of scientific evidence. This 
research also indicates that, in biological systems or in the 
environment, not all materials in the nanoscale size range behave 
differently from larger sized materials of the same substance (Ref. 7). 
Recently, a governmental organization and an independent scientific 
committee have reviewed and summarized this evidence and offered views 
about the implications of this evidence for environmental and human 
health and safety.
    In 2009, the National Institute of Occupational Safety and Health 
(NIOSH) issued a report (Ref. 8) that summarized the available 
scientific information about nanoscale materials and identified the 
following potential health and safety properties:
     ``Nanomaterials have the greatest potential to enter the 
body through the respiratory system if they are airborne and in the 
form of respirable-sized particles (nanoparticles). They may also come 
into contact with the skin or be ingested.''
     ``Based on results from human and animal studies, airborne 
nanoparticles can be inhaled and deposited in the respiratory tract; 
and based on animal studies, nanoparticles can enter the blood stream, 
and translocate to other organs.''
     ``Experimental studies in rats have shown that equivalent 
mass doses of insoluble incidental nanoparticles are more potent than 
large particles of similar composition in causing pulmonary 
inflammation and lung tumors. Results from in vitro cell culture 
studies with similar materials are generally supportive of the 
biological responses observed in animals.''
     ``Experimental studies in animals, cell cultures, and 
cell-free systems have shown that changes in the chemical composition, 
crystal structure, and size of particles can influence their oxidant 
generation properties and cytotoxicity.''
     ``Studies in workers exposed to aerosols of some 
manufactured or incidental microscopic (fine) and nanoscale (ultrafine) 
particles have reported adverse lung effects including lung function 
decrements and obstructive and fibrotic lung diseases. The implications 
of these studies to engineered nanoparticles, which may have different 
particle properties, are uncertain.''
     ``Some nanomaterials may initiate catalytic reactions 
depending on their composition and structure that would not otherwise 
be anticipated based on their chemical composition.''
    Earlier the same year, the Scientific Committee on Emerging and 
Newly Identified Health Risks (SCENIHR), an independent scientific 
committee advising the European Commission's Health and Consumer 
Directorate, issued a report (Ref. 9) that identified properties 
similar to those identified in the NIOSH report:
     ``Some specific hazards, discussed in the context of risk 
for human health, have been identified. These include the possibility 
of some nanoparticles to induce protein fibrillation, the possible 
pathological effects caused by specific types of carbon nanotubes, the 
induction of genotoxicity, and size effects in terms of 
biodistribution.''
     ``For some nanomaterials, toxic effects on environmental 
organisms have been demonstrated, as well as the potential to transfer 
across environmental species, indicating a potential for 
bioaccumulation in species at the end of that part of the food chain.''
    In another survey of scientific research on nanoscale materials 
(Ref. 10), the authors reported:

    Many studies have examined the pro-inflammatory effects of 
manufactured nanoparticles, on the basis that their ability to cause 
inflammation is a major predictor of potential hazard in such 
particles. The first important finding was that nanoparticles have a 
more pronounced effect on inflammation, cell damage and cell 
stimulation than an equal mass of particles of the same material of 
greater size. This appears to hold true for materials as varied as 
carbon black, titanium dioxide, various metals and polystyrene. 
Surface area is the metric driving the pro-inflammatory effects and 
this is evident both in vitro and in vivo, particles of various 
sizes producing inflammatory effects that are directly related to 
the surface area dose.

    A report in the scientific literature has indicated that nanoscale 
polystyrene beads may cross the placental barrier (in an ex-vivo human 
placental perfusion model (Ref. 11). Another study found that 
nanoparticles could translocate to diverse organs following oral 
exposure in rodents. Once in these diverse sites and organs, the large 
surface area of nanoscale materials may facilitate increased reactivity 
and/or an inflammatory response, resulting in toxic effects (Ref. 12).
    Two literature surveys describe a broad range of effects in non-
mammalian species following exposure to nanoscale materials (Ref. 13 
and 14). These include, for example, increased ventilation rates, mucus 
production, and pathologies, and related alteration of enzyme 
activities and indicators of oxidative stress in rainbow trout, 
Oncorhyncus mykiss (Ref. 15) and ingestion and accumulation of 
nanoscale material in the digestive tract, as well as mortality, 
increased heart rates, and reduced fecundity in Daphnia magna (Ref. 16, 
17, and 18). Translocation of nanoscale materials from gill and gut 
surface to blood and other organs in exposed Medaka, Oryzius latipes, 
has also been reported (Ref. 19) and carbon nanotubes, although unable 
to cross the egg surface, have been shown to delay hatching in zebra 
fish, Danio rerio (Ref. 20).
    Published reports of human and ecological exposure to nanomaterials 
are also limited. For example, in its ``Current Intelligence Bulletin 
65: Occupational Exposure to Carbon Nanotubes and Nanofibers'' (Ref. 
21), NIOSH summarized and evaluated the available published information 
on worker exposures to carbon nanotubes (CNT) and nanofibers (CNF). 
NIOSH determined that, although the potential for worker exposure to 
CNT and CNF can occur throughout the life cycle of CNT- and CNF-product 
use (processing, use, disposal, recycling), the extent to which workers 
are exposed has not been completely characterized. ``Comprehensive 
workplace exposure evaluations are needed to characterize and quantify 
worker exposure to CNT and CNF at various job tasks and operations, and 
to determine what control measures are the most effective in reducing 
worker exposures.'' ``Data are particularly needed on workplace 
exposures to CNT and CNF, as well as information on whether in-place 
exposure control measures (e.g., engineering controls) and work 
practices are effective in reducing worker exposures.''
    There are many scientific questions about the impacts of chemical

[[Page 18334]]

substances manufactured at the nanoscale on human health and the 
environment. Part of EPA's mission under TSCA is to understand 
potential risks in order to protect human health and the environment. 
As stated in EPA's White Paper on Nanotechnology (Ref. 22):

    Some of the same special properties that make nanoscale 
materials useful are also properties that may cause some nanoscale 
materials to pose risks to humans and the environment, under 
specific conditions.

EPA needs a sound scientific basis for assessing and managing potential 
impacts resulting from the introduction of chemical substances 
manufactured at the nanoscale into commerce.
    As described in the 2008 TSCA Inventory Status of Nanoscale 
Substances--General Approach, many nanoscale materials are considered 
chemical substances as defined under TSCA section 3(2) (Ref. 23). 
Nanoscale forms of chemical substances that are not on the TSCA 
Inventory in any form are considered new chemical substances that 
require reporting under TSCA section 5. EPA has assessed over 170 of 
these nanoscale materials as new chemical substances and taken action 
to control exposures to prevent any potential unreasonable risks to 
human health or the environment pending development of information 
which will allow EPA to more fully assess those risks. Nanoscale 
materials based on chemical substances already on the TSCA Inventory 
are considered existing chemical substances. These nanoscale materials 
do not require reporting as new chemical substances because they are 
nanoscale forms of chemical substances already in commerce.
    EPA developed a voluntary Nanoscale Materials Stewardship Program 
(NMSP or ``the program'') to complement and support its regulatory 
activities on chemical substances manufactured at the nanoscale. EPA 
conducted the program from January 2008 to December 2009. Thirty one 
companies or associations submitted information to EPA for 132 chemical 
substances manufactured at the nanoscale with available information on 
how those nanoscale materials were manufactured, processed or used. For 
more details on the NMSP, see the program's interim report, a copy of 
which is in the docket (Ref. 24). EPA solicited existing data and 
information, on a voluntary basis, from manufacturers, processors, and 
users of chemical substances manufactured at the nanoscale to 
expeditiously develop knowledge about commercially available nanoscale 
materials. In addition, the program was designed to identify and 
encourage use of risk management practices in developing and 
commercializing chemical substances manufactured at the nanoscale. EPA 
also participated in a series of National Nanotechnology Initiative 
public workshops, including co-Chairing a public Risk Management 
Methods workshop. This workshop was also useful in further identifying 
additional considerations in risk management practices towards 
developing and commercializing chemical substances manufactured at the 
nanoscale of interest to EPA. In the NMSP interim report, which was 
based on the information EPA received prior to January 2009, EPA 
identified data needs for existing nanoscale material production, uses, 
and exposures. For example, in the report EPA estimated that companies 
provided information on only about 10 percent of the chemical 
substances manufactured at the nanoscale that may be commercially 
available in 2009.
    To address some of the data needs identified in the NMSP interim 
report, EPA is proposing reporting requirements under TSCA section 8(a) 
for persons who are manufacturing, or processing chemical substances 
manufactured at the nanoscale or intend to manufacture or process these 
nanoscale materials for commercial purposes. This information would 
facilitate EPA's evaluation of the materials and determination if any 
further action under TSCA, including additional information collection, 
is needed. By gathering data regarding the characteristics, uses, and 
exposure pertaining to chemical substances manufactured at the 
nanoscale, EPA will create a more robust database that will expand the 
Agency's understanding of commercially available nanoscale substances 
including available environmental health and safety data and risk 
management practices.

III. Summary of Proposed TSCA Section 8(a) Rule

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

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

    1. Reportable chemical substances. This proposed rule would apply 
to chemical substances that are solids at 25 [deg]C and atmospheric 
pressure and that are manufactured or processed in a form where the 
primary particles, aggregates, or agglomerates are in the size range of 
1-100 nanometers (nm) and exhibit unique and novel characteristics or 
properties because of their size. The proposed rule would apply to 
chemical substances containing primary particles, aggregates, or 
agglomerates in the size range of 1-100 nm in at least one dimension. 
This proposed rule would not apply to chemical substances that only 
have 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. EPA is proposing these parameters for purposes of 
identifying chemical substances that are subject to the rule, not to 
establish a definition of what is a nanoscale material.
    i. Discrete forms. Manufacturers and processors of multiple 
nanoscale forms of the same chemical substance would, in some cases, 
need to report separately for each discrete form of the reportable 
chemical substance. EPA is proposing to distinguish based on a 
combination of three factors: (1) a change in process to affect a 
change in size and/or a change in properties of the chemical substances 
manufactured at the nanoscale; (2) a change in mean particle size of 
10% or greater; and (3) the measured 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 +/- 5 m\2\/g, then a change resulting in a new 
average specific area of 85 m\2\/g would be reportable if factors 1 and 
2 were also met. EPA recommends using the same medium and method when 
measuring the change in these properties, as even minor changes in the 
medium and methods can result in large differences in the measured 
results. EPA's intent for proposing these reporting requirements is to 
focus reporting on intentionally manufactured chemical substances at 
the nanoscale.
    EPA is proposing the combination of these three factors rather than 
simply size to distinguish between different chemical substances 
manufactured at the nanoscale so that unintended variation in size 
range between production batches would not trigger TSCA section 8(a) 
reporting. Also, EPA is proposing not to rely solely on process changes 
because there may be process changes that are not intended to change 
the material produced but rather intended to improve the efficiency of 
the process or to use a cheaper reactant. EPA is focusing on the 
properties of zeta

[[Page 18335]]

potential, specific surface area, dispersion stability, or surface 
reactivity because these properties are of particular interest in a 
health and safety context, whereas other unique 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 important in a health and 
safety context. EPA believes that the combination of these three 
factors will provide a clear and transparent way for the regulated 
community to distinguish among different chemical substances 
manufactured at the nanoscale for purposes of TSCA section 8(a) 
reporting.
    For the purposes of this proposed rule, specific surface area is 
the ratio of the surface area of the nanoscale material to its mass or 
the area of the surface of the nanoscale material divided by volume. 
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. 
Specific surface area is the ratio of the area of the surface of a 
nanoscale material divided by the mass (m\2\/kg) or the area of the 
surface of the nanoscale material divided by volume (m\2\/m\3\).
    Zeta potential is the electrokinetic potential in colloidal 
systems. It is measured as the net number of positive and negative 
charges per unit particle surface area in Coulomb/m\2\ (Ref. 25) and is 
typically measured by electrophoresis.
    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. 26) as an example.
    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 an entity to lose or 
acquire electrons, and photocatalytic activity, including the potential 
to generate free radicals. Reactive oxygen species (ROS) and free 
radicals are important in considering toxicity for these materials.
    A nanoscale form of a particular chemical substance with a 
different morphology or shape would also qualify as a discrete form. 
Examples include spheres, rods, ellipsoids, cylinders, needles, wires, 
fibers, cages, hollow shells, trees, flowers, rings, tori, cones, and 
sheets. Nanoscale forms of a particular 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 solely as a component of a mixture, 
encapsulated material, or composite would also have to be reported. 
Chemical substances at the nanoscale that are manufactured but are then 
incorporated into mixtures, encapsulated materials or composites by 
that manufacturer would not require separate reporting for their 
incorporation. However, the person reporting the chemical substance 
would have to report each step of its manufacture, processing and use 
to the extent it is known or reasonably ascertainable.
    2. Substances excluded from reporting. EPA is proposing to exclude 
from the requirements of this rule certain biological materials (e.g., 
DNA, RNA, and proteins). EPA is seeking comment to identify other 
specific biological materials that should be excluded from reporting 
and the reasons for excluding them, including microorganisms and viral 
based products (or other combinations of RNA, DNA and protein), lipids, 
carbohydrates, enzymes, and peptides. However, the properties of 
biological materials such as DNA, RNA and proteins are not a function 
of the size range per se but rather the precise nucleotide sequence (in 
the case of DNA and RNA), shape, and other features.
    EPA is proposing to exclude chemical substances which dissociate 
completely in water to form ions that are less than 1 nanometer. This 
exclusion would not apply to chemical substances manufactured at the 
nanoscale materials that release ions but do not dissociate in water to 
form those ions. EPA believes that the chemical substances that would 
be excluded do not exhibit new properties when their size falls in the 
range of 1-100 nanometers and manufacture or processing such substances 
at the nanoscale should therefore not be subject to the reporting 
requirements of the proposed rule. EPA is seeking comment to identify 
other water soluble compounds that should be excluded from reporting 
and the reasons for excluding them.
    EPA is proposing to exclude from the requirements of this rule 
nanoclays, zinc oxide and chemical substances manufactured at the 
nanoscale as part of a film on a surface. The Agency believes that 
information collected on these materials would be of limited value 
because either they have been well-characterized or they present little 
exposure potential. EPA requests comment on these proposed exclusions 
and whether other chemical substances manufactured at the nanoscale 
should be excluded. EPA requests that commenters explain why they 
believe the chemical substances manufactured at the nanoscale should be 
excluded.
    3. General exemptions to TSCA Section 8(a) reporting. The general 
exemptions to TSCA section 8(a) reporting at 40 CFR 704.5 would be 
applicable to this proposed rule. This includes, among other 
exemptions, the exemption for research and development under which a 
person who manufactures or processes, a chemical substance only in 
small quantities for research and development would be exempt from the 
reporting requirements of this proposed rule. Examples of research and 
development (R&D) activity are the analysis of the chemical or physical 
characteristics, the performance, or the production characteristics of 
a chemical substance, a mixture containing the substance, or an 
article. 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.
    EPA is proposing an alternate exemption for the existing small 
manufacturer exemption. Under other TSCA section 8(a) rules, a company 
qualifies as a small manufacturer in 40 CFR 704.3 by meeting either of 
the following two standards. The first is that sales of the company are 
less than $40 million per year and the company does not manufacture 
more than 100,000 pounds annually of an individual substance at any 
individual site owned or controlled by the company. The second is that 
sales are less than $4 million regardless of the quantity manufactured.
    EPA is proposing a different exemption for purposes of this rule by 
eliminating the first standard and defining a small manufacturer or 
processor as any company with sales of less than $4 million. The 
100,000-pound threshold in the existing exemption did not contemplate 
typical production volumes for chemical substances manufactured at the 
nanoscale. EPA has reviewed over 200 chemical substances manufactured 
at the nanoscale in the NMSP and the new chemicals program under TSCA. 
At least 170 of those

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chemical substances manufactured at the nanoscale had reported or 
estimated production volumes less than 22,000 pounds. Based on this 
experience, exempting manufacturers or processors from reporting annual 
production volumes of up to 100,000 pounds would exclude a large 
proportion of companies that characteristically manufacture chemical 
substances manufactured at the nanoscale in small amounts but would not 
otherwise be considered small. Given that chemical substances 
manufactured at the nanoscale tend to be produced in small volumes, EPA 
does not believe production volume should be a relevant consideration 
in determining whether a nanotechnology company is a small manufacturer 
or processor. EPA requests comment on the proposed small manufacturer 
or processor exemption that would apply for this proposed rule.
    4. Proposed exceptions to reporting. The proposed rule would not 
require manufacturers or processors to report certain information that 
has already been submitted to EPA. A person who submitted a TSCA 
chemical notice under section 5 to EPA on or after January 1, 2005 
would not be required to report regarding the same substance under this 
proposed TSCA section 8(a) 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 would be required under this proposed TSCA section 
8(a) rule under the NMSP would not need to report that information 
again under this proposed TSCA section 8(a) rule. If, however, 
information required by this proposed rule was not reported under 
section 5 or the NMSP (including information for each discrete form of 
a reportable chemical substance), then reporting of that information 
would be required under this proposed TSCA section 8(a) rule. The 
purpose of these exemptions is to avoid duplicative reporting. For 
example new chemical notices that have been reviewed as nanoscale 
materials would not be subject to reporting the same information under 
this rule.

B. When would reporting be required?

    EPA proposes that 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 the rule would report to EPA 
six months after the final effective date of the rule. EPA also 
proposes a continuing requirement that persons who intend to 
manufacture or process a discrete form of a reportable chemical 
substance on or after the effective date of the rule would report to 
EPA at least 135 days before commencement of manufacture or processing.
    The 135-day period is based on EPA's experience with PMN 
submissions. TSCA section 8(a) applies to a person ``who manufactures 
or processes or proposes to manufacture or process a chemical 
substance''. A company proposes to manufacture or process a chemical 
substance by forming the intent to do so. Based on EPA's experience, 
persons form the intent to manufacture or process chemical substances 
at least 135 days ahead of time. This belief is based on EPA's 
experience with Premanufacture Notice (PMN) submissions and subsequent 
notices of commencement (NOCs). Pursuant to section 5(a)(1) of TSCA and 
40 CFR 720.22, PMNs are submitted by a person who intends to 
manufacture a chemical substance, at least 90 days before commencing 
manufacture. Under 40 CFR 720.102, a company that has submitted a PMN 
for which the statutory 90-day review period has expired and which has 
commenced manufacture of that substance must submit an NOC to EPA 
within 30 days following commencement. For fiscal years 2009-2011, EPA 
received 1,723 PMNs. Based on EPA's review of NOC receipt date 
information, EPA determined that NOCs were received within 45 days of 
completion of the 90-day PMN review for only 16% of these submitted 
PMNs. Thus, for 84% of the submitted PMNs, the intent to manufacture 
was formed at least 135 days (i.e., the 90-day PMN review period plus 
45 days) before commercialization. Because a company must by necessity 
form the intent to manufacture a chemical substance some period of time 
before the PMN is submitted to EPA, the intent to manufacture or 
process would be made at least 135 days in advance as a general matter.

C. What information would be reported?

    This TSCA section 8(a) rule proposes 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 data.
    EPA developed an information reporting form for the NMSP (Ref. 27) 
which has been slightly modified for purposes of this proposed rule. 
The same information that was requested in the NMSP would be required 
by this proposed rule, including information on specific chemical 
identity, material characterization, physical chemical properties, 
production volume, use, methods of manufacturing and processing, 
exposure and release information, and existing data concerning the 
environmental and health effects. The information would be reported on 
a form similar to that used in the NMSP (Ref. 27). Any person required 
to report under this proposed rule would supply the information 
identified in the form to the extent it is known to or reasonably 
ascertainable by them. A draft of the proposed reporting form (EPA Form 
No. 7710-[tbd]) is available in the docket for public review (Ref. 28).
    EPA is requesting comment on whether any information proposed to be 
collected requested in this proposed rule is duplicative of information 
collected under other federal statutes and, thus should be excluded. 
Please identify the statute and the information that you believe is 
duplicative.

D. How would information be submitted to EPA?

    EPA is proposing electronic reporting similar to the requirements 
established in 2013 for submitting other information under TSCA (see 
proposed 704.20(e)). EPA is proposing to require submitters to use 
EPA's CDX, the Agency's electronic reporting portal, for all reporting 
under this rule. In 2013 (Ref. 1), 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). 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 Notifications. In proposing to require similar electronic 
reporting under this rule, EPA intends to 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 tool is available for use with 
Windows, Macs, 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 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.

[[Page 18337]]

    EPA is proposing to require submitters to follow the same 
submission procedures used for other TSCA submissions, i.e., to 
register with EPA's CDX and use CISS to prepare a data file for 
submission. Registration enables CDX to authenticate identity and 
verify authorization. To submit electronically to EPA via CDX, 
individuals must first register with that system at http://cdx.epa.gov/epa_home.asp. To register in CDX, the CDX registrant (also referred to 
as ``Electronic Signature Holder'' or ``Public/Private Key Holder'') 
agrees to the Terms and Conditions, provides information about the 
submitter and organization, selects a user name and password, and 
follows the procedures outlined in the guidance document for CDX 
available at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf.
    Users who have previously registered with CDX for other TSCA 
submissions, Chemical Data Reporting, or the Toxic Release Inventory 
TRI-ME web reporting flow, would be able to 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 would be required to use CISS to prepare their 
submissions. CISS guides users through a ``hands-on'' 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, the web-based tool 
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 voluntary submissions, such as under 
MOUs, are available, and instructions for uploading PDF attachments or 
other file types, such as XML, and completing metadata information 
would be available through CISS reporting guidance.
    CISS, a web-based reporting tool, also allows the user to choose 
``Print,'' ``Save,'' or ``Transmit through CDX.'' When ``Transmission 
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 login to 
the application and check the status of their submissions. Upon 
successful receipt of the submission by EPA, the status of the 
submissions will be flagged as ``Completed.'' The CDX inbox is 
currently used to notify the users of any correspondence related to 
user registration. Information on accessing the CDX user inbox is 
provided in the guidance document for CDX at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf. To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the 
appropriate links and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html. Procedures for 
reporting chemical substances under this proposed rule would be 
similar. EPA will put a version of the reporting tool in the docket for 
commenters, and is interested in feedback on the extent of and burden 
associated with training for using CDX.
    EPA believes that electronic reporting reduces the reporting burden 
for submitters by reducing the cost and time required to review, edit, 
and transmit data to the Agency. It also allows submitters to share a 
draft submission within their organization, and more easily save a copy 
for their records or future use. The resource and time requirements to 
review and process data by the Agency will also be reduced and document 
storage and retrieval will require fewer resources. EPA expects to 
benefit from receiving electronic submissions and communicating back 
electronically with submitters.
    Any person submitting a reporting form could claim any part or all 
of 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.

IV. Development of Additional Data in Connection With the TSCA Section 
8(a) Rule

    A TSCA section 8(a) rule may require persons subject to the rule to 
submit test data in their possession or control and to describe any 
other data known to or reasonably ascertainable by them, but may not 
require persons to develop test data for submission to the Agency. 
However, in view of the lack of information regarding chemical 
substances manufactured at the nanoscale, EPA would encourage 
respondents to this proposed rule to provide the Agency with any 
relevant data on chemical substances manufactured at the nanoscale they 
decide to develop.
    Persons choosing to develop test data should provide data that 
conform to the Good Laboratory Practice Standards, which are codified 
at 40 CFR part 792. There are also standard test methods available for 
properties and information identified in the proposed rule from a 
number of sources. Some of these sources include but are not limited to 
ASTM International, the International Organization for Standardization, 
the National Institute of Standards and Technology, and the 
Organization for Economic Cooperation and Development. EPA encourages 
persons who intend to conduct testing to consult with the Agency before 
selecting a protocol for testing a chemical substance manufactured at 
the nanoscale. EPA would also encourage persons that would be required 
to submit TSCA section 8(a) data under this proposed rule to provide 
information on the potential benefits regarding the reportable chemical 
substance.

V. Request for Comments

    EPA is seeking public comment on all aspects of this proposed rule. 
In addition to specific requests for comment included throughout this 
document, EPA is interested in comments pertaining to the specific 
issues discussed in this unit. EPA also anticipates conducting a public 
meeting during the comment period to further discuss these and any 
other issues concerning the proposed rule.
    1. Identifying the chemical substances that would be subject to 
reporting. EPA has developed the proposed approach based on the 
approximate size range of 1-100 nm as used by the NNI for defining 
nanotechnology (Ref. 6), experience in conducting assessments of new 
chemicals manufactured at the nanoscale by EPA under TSCA, and data 
submitted to EPA under the NMSP. EPA is soliciting comment on each 
aspect of the proposed approach to identifying the chemical substances 
that would be subject to the reporting requirements of the rule. The 
Agency is seeking comment on these approaches and alternative 
approaches for reporting requirements. For example the proposed rule 
would apply to reportable chemical substances that contain primary 
particles, aggregates, or agglomerates in the size range of 1-100 nm in 
at least one dimension. EPA is seeking comments on that aspect of 
reportable chemical substances. EPA is asking commenters if the current 
proposal sufficiently encompasses these types of reportable chemical 
substances.
    2. Distinguishing between nanoscale forms of a reportable chemical 
substance. EPA considered several different approaches to distinguish 
between nanoscale forms of a reportable chemical substance including a 
percentage or numerical change in measured properties. The agency is 
also seeking comment on an approach based solely on the behavior of the 
reportable chemical substance. For example, if a manufacturer or 
processor knows about

[[Page 18338]]

or engineers a reportable chemical substance with multiple nanoscale 
forms with different performance characteristics then each nanoscale 
form would be reported. If multiple nanoscale forms of a reportable 
chemical substance do not perform differently then only a single report 
of the entire range would be reported. EPA is seeking comment on these 
and other alternative approaches. EPA is especially interested in 
comments on whether these approaches would require reporting of 
sufficiently distinct nanoscale forms of a chemical substance so that 
reporting would be focused on those nanoscale forms with potential for 
significantly different physical or chemical characteristics or 
properties. EPA also seeks comment on each aspect of its proposed 
reporting such as size increments, the number of standard deviations, 
morphology, the specific physical-chemical properties identified, 
exclusions to reporting, and whether companies have the analytical 
tools to make such distinctions.
    3. Reporting discrete forms at least 135 days before commencement 
of manufacture or processing. As discussed in Unit III.B., EPA proposed 
the 135-day period based on EPA's experience with PMN submissions, and 
the determination that the intent to manufacture was formed at least 
135 days before commercialization (i.e., the 90-day PMN review period 
plus 45 days). EPA is specifically seeking comment on whether this 
time-period should be 135 days as proposed, 90 days to be similar to 
the PMN review period, or some other time period. It would be most 
helpful if commenters explain why the time period they suggest is 
appropriate.
    4. Considerations for the Agency's economic analysis. EPA has 
evaluated the potential costs for manufacturers and processors of 
reportable chemical substances for this proposed rule (Ref. 3). EPA is 
specifically seeking additional information and data that EPA could 
consider in developing the final economic analysis. In particular, data 
that could facilitate the Agency's further evaluation of the 
potentially affected industry and firms, including data related to 
potential impacts for those small businesses that would be subject to 
reporting. EPA is especially interested in available data or other 
measures of the number of and potential growth in the number of 
commercial nanoscale materials or firms that might manufacture or 
process such materials.
    5. Electronic reporting. In proposing to require electronic 
reporting under this rule that is similar to those established in 2013 
for other TSCA reporting, EPA intends to save time, improve data 
quality and increase efficiencies for both the submitters and the 
Agency. EPA is specifically interested in comments related to the 
adoption of the existing mechanisms and related procedures for use in 
transmitting the reports proposed in this rule, including comments 
related to the extent to which potentially reporting entities are 
already familiar with those mechanisms given their existing use for 
other TSCA reporting. EPA is also interested in feedback on how 
electronic reporting mechanisms affect reporting entities in terms of 
reporting time, added efficiencies, and potential burden associated 
with training to use the electronic systems (i.e., CDX and CISS).
    6. Consideration of potential future rulemaking regarding periodic 
reporting. EPA is also seeking comment on the possibility of a future 
rule that would require periodic reporting of chemical substances 
manufactured at the nanoscale, similar to reporting that occurs under 
the Chemical Data Reporting (CDR) rule at 40 CFR part 711. Such a rule 
could require manufacturers and processors of chemical substances 
manufactured at the nanoscale to report the type of information 
collected under the CDR rule to EPA at the same reporting interval as 
currently required by CDR reporting (every four years). That reporting 
could occur at lower thresholds for criteria such as production volume. 
The CDR is a program designed to collect screening-level, exposure-
related information on chemical substances and to make that information 
available for use by EPA and to the public consistent with 
confidentiality under TSCA Section 14 and EPA regulations in 40 CFR 
part 2. The CDR rule data are used by EPA to support risk screening, 
assessment, priority setting and management activities and constitute 
the most comprehensive source of basic screening-level, exposure-
related information on chemicals available to EPA. For further 
information see http://www.epa.gov/oppt/cdr.

VI. References

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

1. 2013. EPA. Electronic Reporting Under the Toxic Substances 
Control Act; Final Rule. Federal Register (78 FR 72818, December 4, 
2013) (FRL 9394-6).
2. 2011. Executive Office of the President. Policy Principles for 
the U.S. Decision-Making Concerning Regulation and Oversight of 
Applications of Nanotechnology and Nanomaterials. http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf.
3. 2015. EPA. Economic Analysis for the TSCA Section 8(a) Proposed 
Reporting Requirements for Certain Nanoscale Materials (RIN 2070-
AJ54). March 12, 2015.
4. 2005. EPA. Cross-Media Electronic Reporting Rule (CROMERR); Final 
Rule. Federal Register (70 FR 59848, October 13, 2005) (FRL-7977-1).
5. 2005. Oberd[ouml]rster, Gunter, Oberd[ouml]rster, Eva, and 
Oberd[ouml]rster, Jan. Nanotoxicology: an emerging discipline 
evolving from studies of ultrafine particles. Environmental Health 
Perspectives. (113): 823-839.
6. 2014. National Nanotechnology Initiative (NNI). ``Supplement to 
the President's 2015 Budget,'' p. 3. http://www.nano.gov/sites/default/files/pub_resource/nni_fy15_budget_supplement.pdf.
7. 2009. Auffan, Melanie, Rose, Jerome, Bottero Jean-Yves, Lowry, 
Gregory V Jolivet Jean-Pierre, and Wiesner, Mark R. Towards a 
definition of inorganic nanoparticles from an environmental, health 
and safety perspective. Nature Nanotechnology 4, 634-641. Published 
online: 13 September 2009 [bond] doi:10.1038/nnano.2009.242.
8. 2009. NIOSH. Approaches to Safe Nanotechnology: Managing the 
Health and Safety Concerns Associated with Engineered Nanomaterials. 
Available on-line at http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf.
9. 2009. European Commission, Directorate-General for Health and 
Consumers. Scientific Committee on Emerging and Newly Identified 
Risks (SCENIR), Report: Risk Assessment of Products of 
Nanotechnologies. Available on-line at http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_s_01.pdf.
10. 2009. Seaton, Anthony, Tran, Lang, Aitken, Robert, and 
Donaldson, Kenneth. Nanoparticles, human health hazard and 
regulation. Journal of the Royal Society, Available on-line at 
http://rsif.royalsocietypublishing.org/content/early/2009/08/31/rsif.2009.0252.focus.full#ref-14 .
11. 2010. Wick, Peter, Malek, Antoine, Manser, Pius, Meili, 
Danielle, Maeder-Althaus, Xenia, Diener, Liliane, Diener, Pierre-
Andre, Zisch, Andreas, Krug, Harold F, and Mandach, Ursula von. 
Barrier Capacity of Human Placenta for Nanosized Materials. 
Environmental Health Perspectives. (118):432-436.
12. 2008. Kim, Yong Soon, Kim, Jin Sik, Cho, Hyun Sun, Rha, Dae Sik, 
Kim, Jae Min, Park, Jung Duck, Choi, Byung Sun, Lim, Ruth, Chang, 
Hee Kyung, Chung, Yong Hyun, Kwon, Il Hoon, Jeong, Jayoung, Han, 
Beom Seok, and Yu, Il Je. Twenty-

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Eight Day Oral Toxicity, Genotoxicity, and Gender-Related Tissue 
Distribution of Silver Nanoparticles in Sprague-Dawley Rats. 
Inhalation Toxicology. 20 (6): 575-583.
13. 2008. Handy, Richard D., Von der Kammer, Frank, Lead, Jamie R., 
Hassello, Martin, Owen, Richard, and Crane, Mark. The ecotoxicology 
and chemistry of manufactured nanoparticles. Ecotoxicology 17:287-
314.
14. 2008. Klaine, Stephen J., Alvarez, Pedro J., Batley, Graeme E., 
Fernandes, Teresa F., Handy, Richard D., Lyon, Delina Y., Mahendra, 
Shaily, McLaughlin, Michael J., and Lead, Jamie R. Nanomaterials in 
the Environment: Behavior, Fate, Bioavailability, and Effects. 
Environmental Toxicology and Chemistry. 27: 1825-1851.
15. 2007. Federici, Gillian, Shaw, Benjamin J., and Handy, Richard 
D. Toxicity of titanium dioxide to rainbow trout (Oncorhynchus 
mykiss): Gill injury, oxidative stress, and other physiological 
effects. Aquatic Toxicology. 84: 415-430.
16. 2007. Roberts, Aaron P., Mount, Andrew S., Seda, Brandon, 
Souther, Justin, Qiao, Rui, Lin, Sijie, Ke, Pu Chun, Rao, Apparao 
M., and Klaine, Stephen J. In vivo biomodification of lipid coated 
carbon nanotubes by Daphnia magna. Environmental Science and 
Technology. 41: 3025-3029.
17. 2006. Lovern, Sarah B., and Klaper, Rebecca. Daphnia magna 
mortality when exposed to titanium nanoparticles and fullerene (C60) 
nanoparticles. Environmental Toxicology and Chemistry. 25: 1132-
1137.
18. 2006. Oberd[ouml]rster, Eva, Zhu, Shiqian, Zhu, Blickley, T. 
Michelle, McClellan-Green, Patricia, and Haasch, Mary L. 
Ecotoxicology of carbon-based engineered nanoparticles: effects of 
fullerene (C-60) on aquatic organisms. Carbon. 44: 1112-1120.
19. 2006. Kashiwada, Shosaku. Distribution of nanoparticles in the 
see-through Medaka (Oryzias latipes). Environmental Health 
Perspectives. 114: 1697-1702.
20. 2007. Cheng, Jinping, Flahaut, Emmanuel, and Cheng, Shuk Han. 
Effect of carbon nanotubes on developing zebra fish (Danio rerio) 
embryos. Environmental Toxicology and Chemistry. 26:708-716.
21. 2013. NIOSH. Current Intelligence Bulletin 65: Occupational 
Exposure to Carbon Nanotubes and Nanofibers at http://www.cdc.gov/niosh/docs/2013-145/pdfs/2013-145.pdf.
22. 2007. EPA. EPA Nanotechnology White Paper. Available online at 
http://www.epa.gov/osa/pdfs/nanotech/epa-nanotechnology-whitepaper-0207.pdf.
23. 2008. EPA. TSCA Inventory Status of Nanoscale Substances--
General Approach. Available online at http://www.epa.gov/oppt/nano/nmsp-inventorypaper2008.pdf.
24. 2009. EPA. EPA Interim Report on the Nanoscale Materials 
Stewardship Program. Available online at http://www.epa.gov/oppt/nano/nmsp-interim-report-final.pdf.
25. 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.
26. 2013. ISO/TR. Guidelines for Characterization of Dispersion 
Stability. ISO/TR 13097:2013.
27. 2008. EPA. Nanoscale Materials Stewardship Program Data 
Submission Form. EPA Form No. 7710-25-NMSP; EPA ICR No. 2250.01; OMB 
Control No. 2070-0170.
28. 2015. EPA. Proposed Data Submission Form. TSCA 8(a) Data 
Reporting for Nanoscale Materials. EPA Form No. 7710-[tbd]; EPA ICR 
No. 2517.01; OMB Control No. 2070-NEW.
29. 2015. EPA. Proposed Addendum to an Existing EPA ICR Entitled: 
Chemical-Specific Rules, Toxic Substances Control Act Section 8(a). 
EPA ICR No. 2517.01; OMB Control No. 2070-NEW.

VII. Statutory and Executive Order Reviews

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

    The Office of Management and Budget (OMB) has designated this 
proposed rule as a ``significant regulatory action'' under section 3(f) 
of Executive Order 12866 (58 FR 51735, October 4, 1993). Accordingly, 
EPA submitted this proposed rulemaking to OMB for review under 
Executive Order 12866 and Executive Order 13563 (76 FR 3821, January 
21, 2011), and any changes made in response to OMB comments have been 
documented in the public docket for this rulemaking as required by 
section 6(a)(3)(E) of Executive Order 12866.

B. Paperwork Reduction Act (PRA)

    An agency may not conduct or sponsor, and a person is not required 
to respond to an information collection request subject to the PRA, 44 
U.S.C. 3501 et seq., unless it displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations are listed in 40 
CFR part 9 and included on any related collection instrument (e.g., on 
the form or survey).
    The information collection requirements in 40 CFR part 704 related 
to TSCA section 8(a) reporting rules have already been approved by OMB 
under the PRA. That information collection request (ICR) has been 
assigned EPA ICR No. 1198.10 and OMB Control No. 2070-0067. Because 
this proposed rule would involve revised information collection 
activities that require additional OMB approval, EPA has prepared an 
addendum to the currently approved ICR. The addendum, identified under 
EPA ICR No. 2517.01 and OMB Control No. 2070-NEW (Ref. 29), is 
available in the docket and is briefly summarized here.
    If an entity were to submit a report to the Agency, the annual 
burden is estimated to average 137 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 proposed TSCA section 8(a) rule 
would create an industry burden of approximately 206,098 hours in the 
first year and 22,755 hours in subsequent years.
    To comment on the Agency's need for this information, the accuracy 
of the provided burden estimates, and any suggested methods for 
minimizing respondent burden, EPA has established a docket for this 
proposed rule, which includes this ICR, under docket ID number EPA-HQ-
OPPT-2010-0572. Submit any comments related to the ICR to EPA and OMB. 
See ADDRESSES for where to submit comments to EPA. Send comments to OMB 
via email to oira_submission@omb.eop.gov. Address comments to OMB Desk 
Officer for EPA.
    Since OMB is required to make a decision concerning the ICR between 
30 and 60 days after April 6, 2015, a comment to OMB is best assured of 
having its full effect if OMB receives it by May 6, 2015. The final 
rule will respond to any OMB or public comments on the information 
collection requirements contained in this proposed rule.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I 
hereby certify that this action would not have a significant adverse 
economic impact on a substantial number of small entities. The 
rationale supporting this conclusion is summarized here, and is 
presented in a small entity impact analysis that EPA prepared for this 
proposed action that is part of the Agency's economic analysis in the 
public docket for this proposed rule (Ref. 3).
    Under the RFA, small entities include small businesses, small 
organizations, and small governmental jurisdictions. For purposes of 
assessing the impacts of this proposed rule on small entities, small 
entity is defined as: (1) a small business, as defined by the Small 
Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a 
small governmental jurisdiction that is a government of a city, county, 
town, school district or special district with a population of less 
than 50,000; and (3) a small organization that is any not-for-

[[Page 18340]]

profit enterprise which is independently owned and operated and is not 
dominant in its field. Since the regulated community is not expected to 
include small governmental jurisdictions or small not-for-profit 
organizations, the analysis focuses on small businesses.
    A small business exemption exists under TSCA section 8(a) reporting 
rules, at 40 CFR 704.5(f). For this action, EPA is proposing to modify 
the exemption. EPA analyzed potential small business impacts from this 
proposed rule using both the SBA employee size standards and the TSCA 
sales-based definition of small business. EPA estimates that up to 174 
small businesses may be impacted by the proposed TSCA section 8(a) 
reporting rule and evaluated the number that may incur costs at below 
1%, between 1% and 3%, and above 3% of sales. EPA estimates that all 
174 small businesses identified would incur costs below 1% of sales.
    EPA continues to be interested in the potential impacts of this 
proposed rule on small entities that are not exempt from reporting and 
welcomes comments on issues related to such impacts.

D. Unfunded Mandates Reform Act (UMRA)

    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 would be impacted by 
this rulemaking. In addition, this action will not result in annual 
expenditures of $100 million or more for the private sector. As such, 
EPA has determined that this action does not impose any enforceable 
duty, contain any unfunded mandate, or otherwise have any effect on 
small governments, and that the requirements of sections 202, 203, 204, 
or 205 of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.

E. Executive Order 13132: Federalism

    This action does 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, as specified in Executive Order 13132 (64 FR 
43255, August 10, 1999).

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

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

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

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

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

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

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994), because EPA has determined that this action 
will not have disproportionately high and adverse human health or 
environmental effects on minority or low-income populations. This 
action does not affect the level of protection provided to human health 
or the environment.
    This action does not affect the level of protection provided to 
human health or the environment. However, the Agency believes that the 
information collected under this proposed rule, if finalized, will 
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 
protect human health and the environment, including in low-income and 
minority communities.

List of Subjects in 40 CFR Part 704

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

    Dated: March 20, 2015.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

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

PART 704 [AMENDED]

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.
    Chemical Information Submission System or CISS means EPA's 
electronic, web-based reporting tool for the completion and submission 
of data, reports, and other information, or its successors.
    A discrete form of a reportable chemical substance differs from 
another

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form of the same reportable chemical substance in that either:
    (1) The change in the reportable chemical substance is due to all 
of the following:
    (i) There is a change in process to affect a change in size and/or 
a change in one or more of the properties of the reportable chemical 
substances identified in (iii);
    (ii) 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
    (iii) There is a measured 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 value (+/- 7 times the standard deviation);
    (2) 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; or
    (3) 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.
    The 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.
    Primary particles are particles or droplets that form during 
manufacture of a chemical substance before aggregation or 
agglomerization occurs.
    A reportable chemical substance is a chemical substance that is 
solid at 25 [deg]C and atmospheric pressure that is manufactured or 
processed in a form where the primary particles, aggregates, or 
agglomerates are in the size range of 1-100 nm and exhibit unique and 
novel characteristics or properties because of their size. 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.
    A 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 $ 4 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\.
    Zeta Potential is the electrokinetic potential in colloidal 
systems. It is measured as the net number of positive and negative 
charges per unit particle surface area in Coulomb/m\2\.
    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.
    (b) Persons who must report.
    (1) 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 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) 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) Zinc oxide
    (ii) Nanoclays
    (iii) Chemical substances manufactured at the nanoscale as part of 
a film on a surface
    (iv) DNA
    (v) RNA
    (vi) Proteins
    (vii) Chemical substances which dissociate completely in water to 
form ions that are smaller than 1 nanometer.
    (2) Persons who submitted a TSCA chemical notice under 40 CFR part 
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 manufactured or 
processed 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 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

[[Page 18342]]

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 data concerning the environmental and health effects.
    (e) How to report. You must use CDX and the CISS tool to complete 
and submit the information required under this part to EPA 
electronically.
    (1) Reporting form. You must complete EPA Form No. 7710-xx, TSCA 
Sec.  8(a) Reporting for Nanoscale Materials: Data 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 six months 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 the 
chemical substance.
    (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. Persons submitting a notice 
under this rule are subject to the requirements for confidential 
business information claims in Sec.  704.7.

[FR Doc. 2015-07497 Filed 4-3-15; 8:45 am]
 BILLING CODE 6560-50-P
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