Prepublication Copy Notice:

The Assistant Administrator for Chemical Safety and Pollution Prevention signed the 

following Federal Register document on March 20, 2015:

Title: Proposed Rule – Chemical Substances When Manufactured or 

Processed as Nanoscale Materials; TSCA Reporting and 

Recordkeeping Requirements

FRL: 9920-90

Docket No.: EPA-HQ-OPPT-2010-0572

This is a prepublication version of the document that EPA is submitting for 

publication in the Federal Register. While the Agency has taken steps to ensure the 

accuracy of this prepublication version of the document, it is not the official version

of the document for purposes of public comment or judicial review. Please refer to the 

official version of the document that will appear in a forthcoming Federal Register

publication, which is currently expected to occur within 10 work days of the signature 

date. 

 

Once the official version of the document publishes in the Federal Register, the 

prepublication version of the document posted on the agency’s internet will be 

replaced with a link to the document that appears in the Federal Register publication. 

At that time, you will also be able to access the on-line docket for this Federal 

Register document at http://www.regulations.gov. 

For further information about the docket and, if applicable, instructions for 

commenting, please consult the ADDRESSES section in the front of the Federal 

Register document.
BILLING CODE 6560–50–P

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.

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 

Page 1 of 48
benefits and costs of further measures, and making future decisions based on available scientific 

evidence. 

DATES: Comments must be received on or before [insert date 90 days after date of publication 

in the Federal Register].

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 number: (202) 564-8974; e-mail address: alwood.jim@epa.gov.

Page 2 of 48
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South 

Clinton Ave., Rochester, NY 14620; telephone number: (202) 554–1404; e-mail address: TSCAHotline@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).

Page 3 of 48
• 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 

Page 4 of 48
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 

Page 5 of 48
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 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 

Page 6 of 48
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 

Page 7 of 48
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 CDROM 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 

Page 8 of 48
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? 

Page 9 of 48
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 

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 

Page 10 of 48
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 

Page 11 of 48
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.” 

Page 12 of 48
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), 

Page 13 of 48
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 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 

Page 14 of 48
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. 

Page 15 of 48
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 oC 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 

Page 16 of 48
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 m2

/g, then a change 

resulting in a new average specific area of 85 m2/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 potential, specific surface area, dispersion stability, or surface reactivity 

Page 17 of 48
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 (m2

/kg) or the area of the surface of the nanoscale material divided by volume (m2/m3).

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/m2 (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 

Page 18 of 48
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. 

Page 19 of 48
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 

Page 20 of 48
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 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. 

Page 21 of 48
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 

Page 22 of 48
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 

Page 23 of 48
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.

Page 24 of 48
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. 

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 

Page 25 of 48
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 

Page 26 of 48
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 

Page 27 of 48
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 

Page 28 of 48
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 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 physicalchemical 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 

Page 29 of 48
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 

Page 30 of 48
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. DecisionMaking Concerning Regulation and Oversight of Applications of Nanotechnology and 

Nanomaterials. http://www.whitehouse.gov/sites/default/files/omb/inforeg/foragencies/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).

Page 31 of 48
5. 2005. Oberdörster, Gunter, Oberdörster, Eva, and Oberdörster, 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 | 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 online 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, 

Page 32 of 48
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-Eight Day Oral Toxicity, 

Genotoxicity, and Gender-Related Tissue Distribution of Silver Nanoparticles in SpragueDawley 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.

Page 33 of 48
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. Oberdörster, 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.

Page 34 of 48
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: ChemicalSpecific 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 

Page 35 of 48
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 a total incremental industry burden of 228,853 hours. 

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 [insert date of publication in the Federal Register], a comment to OMB is best assured of 

having its full effect if OMB receives it by [Insert date 30 days after publication in the Federal 

Page 36 of 48
Register]. 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-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 

Page 37 of 48
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).

Page 38 of 48
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 

Page 39 of 48
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.

Page 40 of 48

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

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

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

2. By adding § 704.20 to Subpart B, to read as follows 

§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 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);

Page 42 of 48
(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 oC 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 

Page 43 of 48
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 (m2

/kg) and the specific surface area by 

volume is the area of the surface of the reportable chemical substance divided by its volume 

m2/m3.

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/m2. 

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. 

Page 44 of 48
(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 

Page 45 of 48
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 § 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.

Page 46 of 48
(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 

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 §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.

Page 47 of 48
(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 §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 §704.7.

Page 48 of 48