18330 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Proposed Rules 

is not required for an exemption from 

the requirement of a tolerance. Contact: 

RD. 

6. PP IN–10781. (EPA–HQ–OPP– 

2015–0018). Technology Sciences 

Group, Inc., 1150 18th Street NW., Suite 

1000, Washington, DC 20036, on behalf 

of BYK Additives, Inc., 1600 W. Hill 

Street, Louisville, KY 40210, requests to 

establish an exemption from the 

requirement of a tolerance for residues 

for quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite (CAS Reg. No. 1574487–61–8), 

when used as an inert ingredient in 

pesticide formulations applied to 

growing crops only under 40 CFR 

180.920. The petitioner believes no 

analytical method is needed because it 

is not required for an exemption from 

the requirement of a tolerance. Contact: 

RD. 

7. PP IN–10784. (EPA–HQ–OPP– 

2015–0064). Momentive Performance 

Materials, 260 Hudson River Rd., 

Waterford, NY 12188, on behalf of the 

Dow Chemical Company, 2301 N. 

Brazosport Blvd., Freeport, TX 77541, 

requests to establish an exemption from 

the requirement of a tolerance for 

residues of acrylic acid, butyl acrylate, 

styrene copolymer (CAS Reg. No. 

25586–20–3) with a minimum number 

average molecular weight (in amu) of 

5,200, when used as an inert ingredient 

in pesticide formulations under 40 CFR 

180.960. The petitioner believes no 

analytical method is needed because it 

is not required for an exemption from 

the requirement of a tolerance. Contact: 

RD. 

Amended Tolerance Exemption 

1. PP 2E8080. (EPA–HQ–OPP–2013– 

0098). Toxcel, LLC, 7140 Heritage 

Village Plaza, Gainesville, VA 20156 on 

behalf of Penn A Kem, LLC, 3324 

Chelsea Avenue, Memphis, TN 38108, 

requests to amend an exemption from 

the requirement of a tolerance in 40 CFR 

180.1263 for residues of 

tetrahydrofurfuryl alcohol (THFA), 

(CAS Reg. No. 97–99–4), when used as 

a pesticide inert ingredient (solvent/cosolvent), to include allowance of one 

herbicide application prior to the 

preboot stage to wheat, buckwheat, 

barley, oats, rye, sorghum, triticale, rice 

and wild rice; extended use on canola 

to the early bolting stage; extended use 

on soybeans up to the bloom growth 

stage; and allowance of use in 

herbicides with two applications to field 

corn and pop corn up to 36 inches tall 

(V8 stage). The petitioner believes no 

analytical method is needed because it 

is not required for the amendment of an 

exemption from the requirement of a 

tolerance. Contact: RD. 

2. PP 4F8336. (EPA–HQ–OPP–2008– 

0762). BASF Corporation, 26 Davis Dr., 

Research Triangle Park, NC 27709, 

requests to amend an exemption from 

the requirement of a tolerance in 40 CFR 

180.1128 for residues of the 

biofungicide, Bacillus 

amyloliquefaciens MBI 600 (antecedent 

Bacillus subtilis MBI 600), in or on all 

food commodities, including residues 

resulting from post-harvest uses, when 

applied or used in accordance with 

good agricultural practices. The 

petitioner believes no analytical method 

is needed because Bacillus 

amyloliquefaciens MBI 600 (antecedent 

Bacillus subtilis MBI 600) has an 

exemption from the requirement of a 

tolerance without numerical limitations. 

Contact: BPPD. 

Amended Tolerance 

PP 4E8328. (EPA–HQ–OPP–2014– 

0878). Interregional Research Project 

Number 4 (IR–4), 500 College Road East, 

Suite 201 W, Princeton, NJ 08540, 

requests to amend the existing tolerance 

in 40 CFR part 180.411 for residues of 

the herbicide fluazifop-p-butyl in or on 

rhubarb, from 0.5 parts per million 

(ppm) to 0.4 ppm. Analytical 

methodology has been developed and 

validated for enforcement purposes. 

This method has been submitted to the 

Agency and is in PAM Vol. II, Method 

II. Contact: RD. 

Authority: 21 U.S.C. 346a. 

Dated: March 30, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

[FR Doc. 2015–07828 Filed 4–3–15; 8:45 am] 

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 

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 


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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 caseby-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 


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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 


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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 proinflammatory 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 nonmammalian 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 


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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 °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 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 


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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 (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 

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 wellcharacterized 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 userfriendly 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. 


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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 


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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 screeninglevel, 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/for-agencies/

nanotechnology-regulation-andoversight-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. Oberdo ̈rster, Gunter, Oberdo ̈rster, 

Eva, and Oberdo ̈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 | doi:10.1038/ 

nnano.2009.242. 

8. 2009. NIOSH. Approaches to Safe 

Nanotechnology: Managing the Health 

and Safety Concerns Associated with 

Engineered Nanomaterials. Available online at http://www.cdc.gov/niosh/docs/

2009-125/pdfs/2009-125.pdf. 

9. 2009. European Commission, DirectorateGeneral 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, MaederAlthaus, 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. TwentyVerDate Sep<11>2014 15:03 Apr 03, 2015 Jkt 235001 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 E:\FR\FM\06APP1.SGM 06APP1

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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. 

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. Oberdo ̈rster, Eva, Zhu, Shiqian, 

Zhu, Blickley, T. Michelle, McClellanGreen, 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/epananotechnology-whitepaper-0207.pdf. 

23. 2008. EPA. TSCA Inventory Status of 

Nanoscale Substances—General 

Approach. Available online at http://

www.epa.gov/oppt/nano/nmspinventorypaper2008.pdf. 

24. 2009. EPA. EPA Interim Report on the 

Nanoscale Materials Stewardship 

Program. Available online at http://

www.epa.gov/oppt/nano/nmsp-interimreport-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: 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 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) 

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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] 

■ 1. The authority citation for part 704 

continues to read as follows: 

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

■ 2. Add § 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 


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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 °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 (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. 

(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 § 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 


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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. 

(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. 

[FR Doc. 2015–07497 Filed 4–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 12 

[PS Docket No. 14–193; PS Docket No. 13– 

75; FCC 14–186] 

911 Governance and Accountability; 

Improving 911 Reliability 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule; extension of 

comment and reply comment deadlines. 

SUMMARY: In this document, the Public 

Safety and Homeland Security Bureau 

(Bureau) extends the deadline for filing 

comments and reply comments on its 

911 Governance and Accountability 

Notice of Proposed Rulemaking (911 

Governance NPRM), which sought 

comment on mechanisms to ensure, in 

cooperation with state and local 

partners, that the nation’s 911 

governance structure keeps pace with 

evolving technology so that all entities 

providing 911 service capabilities 

remain accountable for reliable 911 call 

completion and accurate situational 

awareness. 

DATES: The comment period for the 

proposed rule published January 22, 

2015 (80 FR 3191) is reopened. 

Comments were due on or before March 

23, 2015, and reply comments are due 

on or before April 21, 2015. 

ADDRESSES: You may submit comments 

to the 911 Governance NPRM, identified 

by PS Docket Nos. 14–193 and 13–75, 

by any of the following methods: 

• Electronic Filers: Federal 

Communication Commission’s 

Electronic Comments Filing System 

(ECFS): http://fjallfoss.fcc.gov/ecfs2/. 

Follow the instructions for submitting 

comments. 

• Paper Filers: All hand-delivered or 

messenger-delivered paper filings for 

the Commission’s Secretary must be 

delivered to FCC Headquarters at 445 

12th Street SW., Room TW–A325, 

Washington, DC 20554. The filing hours 

are 8 a.m. to 7 p.m. Eastern Time (ET). 

All hand deliveries must be held 

together with rubber bands or fasteners. 

Any envelopes and boxes must be 

disposed of before entering the building. 

Commercial overnight mail (other than 

U.S. Postal Service Express Mail and 

Priority Mail) must be sent to 9300 East 

Hampton Drive, Capitol Heights, MD 

20743. U.S. Postal Service first-class, 

Express, and Priority mail must be 

addressed to 445 12th Street SW., 

Washington, DC 20554. 

• People With Disabilities: To request 

materials in accessible formats for 

people with disabilities (braille, large 

print, electronic files, or audio format), 

send an email to fcc504@fcc.gov or call 

the Consumer & Governmental Affairs 

Bureau at 202–418–0530 (voice), (202) 

418–0432 (TTY). 

FOR FURTHER INFORMATION CONTACT: Eric 

Schmidt, Attorney Advisor, Public 

Safety and Homeland Security Bureau, 

(202) 418–1214, eric.schmidt@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Bureau’s Order in PS 

Docket Nos. 14–193 and 13–75, DA 15– 

299, adopted and released on March 6, 

2015, and pertaining to the proposed 

rule published January 22, 2015 (80 FR 

3191). The complete text of this 

document is available for public 

inspection and copying from 8 a.m. to 

4:30 p.m. ET Monday through Thursday 

or from 8 a.m. to 11:30 a.m. ET on 

Fridays in the FCC Reference 

Information Center, 445 12th Street SW., 

Room CY–A257, Washington, DC 20554. 

The complete text is also available on 

the Commission’s Web site at http://

transition.fcc.gov/Daily_Releases/Daily_

Business/2015/db0306/DA-15- 

299A1.pdf, or by using the search 

function on the ECFS Web page at 

http://www.fcc.gov/cgb/ecfs/. 

Summary 

The Bureau released an Order on 

March 6, 2015, which extends the 

comment and reply comment filing 

deadlines for the 911 Governance 

NPRM, 80 FR 3191, January 22, 2015. 

The Order responded to a joint petition 

by the Association for 

Telecommunications Industry Solutions 

(ATIS); the Association of Public Safety 

Communications Officials International 

(APCO); the Industry Council for 

Emergency Response Technologies 

(iCERT); the National Association of 

State 911 Administrators (NASNA); the 

National Emergency Number 

Association (NENA); and the United 

States Telecom Association (USTA) 

seeking an extension of the comment 

period. Pursuant to sections 4(i) of the 

Communications Act of 1934, as 

amended, and pursuant to the authority 

delegated in 47 CFR 0.191, 0.392, and 

1.46, the Bureau extended the deadline 

for filing comments until March 23, 

2015, and extends the deadline for reply 

comments until April 21, 2015. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary. 

[FR Doc. 2015–07392 Filed 4–3–15; 8:45 am] 

BILLING CODE 6712–01–P 


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