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*** Deliberative Document – Do NOT Cite, Quote or Release ***

Reference 1 –

Response to Comments to the Proposed Rule, Chemical Substances When

Manufactured or Processed as Nanoscale Materials; TSCA Reporting and

Recordkeeping Requirements

The chemical substances subject to this rule are chemical substances as

defined in section 3 of TSCA.

December 27, 2016

Docket # EPA-HQ-OPPT-2010-0572

RIN 2070-AJ54

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Comment 1: Several commenters stated that TSCA applies to chemical substances not different

physical forms or different particle sizes of chemical substances and that discrete forms or

discrete physical forms are not “chemical substances” subject to reporting under section 8(a) of

TSCA.

Response: TSCA section 8(a) authorizes EPA to promulgate rules for submissions of such

reports as the Agency “may reasonably require.” EPA believes that the information from this

reporting will help EPA to determine whether chemical substances manufactured and processed

at the nanoscale may exhibit behavior relevant to health and safety that is different from that of

non-nanoscale forms of chemical substances. EPA thus has the authority to require reporting

pertaining to different forms of chemical substances.

Comment 2: Commenters stated that molecular structure, molecular identity, (one commenter

defined molecule as the smallest fundamental unit of a compound that can take part in a

chemical reaction), chemical substance definition, CAS Index name and chemical nomenclature

have been used by EPA to distinguish chemical substances when administering TSCA. Some of

these commenters cited the premanufacture notice (PMN) program as an example of how TSCA

applies these parameters to chemical substances. The commenters asked why EPA had

authority under section 8(a) of TSCA to require reporting for discrete physical forms of existing

chemical substances while it defined chemical substances differently under section 5 of TSCA.

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Response: How EPA applies section 5 of TSCA for reporting of new chemical substances that

are not on the TSCA Inventory may be different from reporting requirements for certain

chemical substances at the nanoscale under Section 8 of TSCA. The parameters identified by

commenters to distinguish chemical identity would not distinguish non-nanoscale forms of

chemical substances from nanoscale forms of chemical substances. EPA does not want to

require reporting of non-nanoscale forms of chemical substances in this rule.

Comment 3: Several commenters stated that reporting on chemical substances that are

nanoscale materials as described in the proposed rule was not justified on the basis of health or

environmental risk; health or environmental hazards; or potential for exposure. Reporting

should not be based on a chemical substance being nanoscale or other arbitrary parameters.

EPA should gather further information on properties or characteristics regarding hazards and

exposures then focus reporting requirements based on these parameters.

Response: TSCA section 8(a) rules are not based on risk or hazard findings. In the proposed

rule EPA discussed and referenced numerous studies illustrating the differences that exist

between chemical substances and chemical substances manufactured in nanoscale forms.

Altering the size of a material from conventional particle size can produce unique or novel

properties that are desirable for a variety of commercial applications. However, these unique or

novel properties can also result in nanoscale materials presenting increased hazards to humans

and the environment. Because of the potential for unique and novel properties of nanoscale

materials, EPA needs more information about chemical substances manufactured and processed

at the nanoscale that are in commerce and available health and safety information. Despite a

voluntary reporting program for chemical substances at the nanoscale and research for its

economic analysis, EPA has been unable to obtain reliable information about chemical

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substances at the nanoscale in commerce and any available hazard and exposure information

regarding those nanoscale chemical substances. The purpose of the TSCA section 8(a) rule is to

obtain this information and determine if any additional information gathering or risk reduction

actions under TSCA are needed.

Comment 4: Several commenters stated that the proposed information requests are outside those

allowed by section 8(a) of TSCA. Commenters specifically identified material characterization

including particle size and morphology, methods of manufacture, weight percent of impurities,

environmental release information, general population, consumer exposure, risk management

practices, and engineering controls. One commenter wanted EPA to explain more clearly the

basis of authority for requesting information that does not fall within the scope of the clear

statutory authority of TSCA section 8(a).

Response: Section 8(a) gives EPA broad authority to collect information that the Administrator

may reasonably require. The categories in section 8(a)(2) are examples of what can be required

under section 8(a). Section 8(a)(1) authorizes EPA to require reporting of such information with

respect to chemical substances as the Administrator may reasonably require. Although it

contains limitations with respect to requirements to report with mixtures and to chemical

substances manufactured in small quantities for experimentation, those limitations are not

relevant to the requirements imposed by this rulemaking. Section 8(a)(2) is best interpreted as

listing examples of the kinds of information EPA can require reporting on under section 8(a)(1),

not as limiting EPA’s authority. If Congress had intended to impose limitations on EPA’s

section 8(a)(1) authority, it would have added them to the limitations it included in section 8(a)

(1). EPA has always interpreted section 8(a) in this fashion, see 58 FR 63134 (November 30,

1993) – an interpretation that is supported by the legislative history of section 8(a), H.R. Conf.

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Rep. 94-1679, at 80 (1976); S. Rep. No. 94-698, at 22 (1976), H.R. Rep. No. 94-1341, at 42

(1976).

Further, the information required under the rule is consistent with the examples of

information discussed in section 8(a)(2). For example, requiring weight percent of impurities is

analogous to byproducts (and EPA has long interpreted impurities to be within the scope of

information that it may require under section 5(b)(1)(A) of TSCA, which incorporates section

8(a)(2); see 40 CFR 720.45(b)), material characterization including particle size and morphology

is analogous to the molecular structure of chemical substances manufactured and processed at

the nanoscale, environmental release falls under methods of disposal, while methods of

manufacture, risk management practices, engineering controls, general population and consumer

exposure fall under estimates of individuals who would be exposed (see 740.45(g)). Adopting a

narrow interpretation of section 8(a) rulemaking authority as suggested by the commenters

would result in EPA being unable to require available characterization information that

differentiates one form of a discrete reportable chemical substance from another form. EPA

would also be unable to require available estimates of the amounts of human and environmental

exposure.

Comment 5: Several commenters supported the proposed data collection elements and use of the

proposed form. One commenter suggested additional details on reporting exposure and release

information relating to publicly owned treatment works (POTW) including function and

application categories to be used for reporting, and whether discharges were directly to sewers

or from products without direct or common pathways for discharges. Another commenter

suggested including experimental conditions when measuring zeta potential and other physical-

chem properties.

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Response: Until EPA has further information on nanoscale forms of certain chemical substances

in commerce that are being released to water and for which uses, the level of detail suggested by

the commenter for POTW releases would be better addressed by additional TSCA actions or

actions under other statutes. If a person subject to the requirements of this rule is reporting

physical-chemical properties, they would be required to submit available or reasonably

ascertainable data regarding the physical-chemical properties which could include descriptions of

the experimental conditions.

Comment 6: Another commenter asked EPA to evaluate the need for the extensive data elements

in the proposed reporting form which is different from previous TSCA section 8(a) rules and

current TSCA section 5 reporting.

Response: When EPA considered the types of information to be reported, it considered the types

of information that would be needed to achieve the goals identified in the proposed rule to find

out about chemical substances at the nanoscale in commerce and information on how those

chemical substances could be better assessed. The information is important because it is the

information EPA uses to assess risks to human health and the environment for chemical

substances. Some information collection elements were added specific to nanoscale materials

that were not included in previous reporting requirements because those reporting requirements

did not focus on information specific to nanoscale forms of chemical substances.

Comment 7: Several commenters proposed much more limited reporting of information because of

potential burden with one commenter suggesting that companies report only some chemical

identity and characterization information and characteristics exhibited by the chemical

substance in its nanoscale form because of its size.

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Response: Information required by this rule must only be reported if it is known to or

reasonably ascertainable by persons subject to the rule. This 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. Because TSCA section 8(a) rules do not

require companies to develop or report information that is not known or reasonably

ascertainable, the current descriptions for information to be reported such as chemical identity

and characterization, human exposure and environmental release, test data, physical properties,

and information specific to nanoscale materials will allow persons subject to the rule to identify

and report available information without undue burden.

Comment 8: One commenter asked EPA to clarify what was required to be reported for an

overview of the life cycle of the nanoscale material while another commenter stated that EPA

should evaluate the need for the reporting of the overview of life cycle.

Response: EPA will remove the requirement for an overview of the life cycle in Section C of the

reporting form, as that information duplicates information already identified in the reporting

requirements of manufacturing, processing and use information in Sections A, B, and D.

Comment 9: Commenters suggested using the chemical data reporting (CDR) and the

Preliminary Assessment Information Rule (PAIR) forms as a basis for reporting because of

previous use in TSCA section 8(a) rules and because the proposed form goes beyond information

allowed to be reported under TSCA section 8(a).

Response: As described in the response to comment 3, all of the information required by this

rule may be required under section 8(a). When EPA selected the form for reporting, it considered

the types of reasonably ascertainable information to be reported that would be needed to achieve

the goals identified in the proposed rule to find out about nanoscale materials in commerce and

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information on how those nanoscale materials could be better assessed. The PAIR and CDR

forms do not provide sufficient information to allow EPA to analyze the impact of chemical

substances produced at the nanoscale.

Comment 10: Many commenters stated the proposal gives too much discretion to interpret

compliance obligations. Commenters suggested clarifying the definition of unique or novel

properties, adopting an alternative, or not using it at all. One commenter noted that if the

requirement that reportable chemicals exhibit unique and novel attributes due to particle size is

removed from the definition, the rule would not differentiate genuinely new nanoscale materials

from traditional legacy products in commerce. Several commenters stated there should be some

differentiation between genuinely new nanoscale materials in commerce and traditional

products. Two commenters supported the definition while one commenter supported a definition

of 1-100 nm and unique or novel characteristics.

Response: Based on these comments, EPA agrees that what is a reportable chemical substance

should be better defined and clarified. EPA is finalizing the rule with further explanation of

“unique and novel properties” as described in the National Nanotechnology Initiative’s

definition. Some nanostructured materials are stronger or have different magnetic properties

compared to other forms or sizes of the same material. Others are better at conducting heat or

electricity. See www.nano.gov. They may become more chemically reactive or reflect light

better or change color as their size or structure is altered. A property is novel when it is different

from the properties associated with other forms or sizes of the same chemical substance. As also

noted on www.nano.gov , when particle sizes of solid matter in the visible scale are compared to

what can be seen in a regular optical microscope, there is little difference in the properties of the

particles. But when particles are created with dimensions of about 1–100 nanometers, the

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http://www.nano.gov/


materials’ properties can change significantly from those at larger scales. See also comment 11

and the response for further clarification on what is considered a reportable chemical substance.

For purposes of this rule, EPA is defining unique and novel properties to include an

element of intent, meaning that those properties are the reason why the chemical substance is

manufactured in that form or size. The rule includes a definition of unique and novel properties

in the definitions section of the regulatory text (See 704.20(a)). Unique and novel properties

means any size-dependent properties that vary from those associated with other forms or sizes of

the same chemical substance, and such properties are a reason that the chemical substance is

manufactured or processed in that form or size. In order to be reportable it’s not sufficient that a

chemical substance contains particles in the size range of 1-100 nanometers; it must also have a

size-dependent property different from properties at sizes greater than 100 nanometers and those

properties are the reason that the chemical substance is manufactured or processed in that form

or size. Intentionally manufacturing or processing nanoscale gold so that it exhibits a red or

purple color instead of a yellow color would create a unique or novel optical property seen at the

nanoscale. Such a change would likely result in changes of other properties, such as specific

surface area which can result in different health and safety impacts. Unique and novel properties

which impact performance generally cannot be isolated from concurrent changes in properties

that impact biological systems. For example, see the discussion in Unit II.B. of the proposed rule

of the range of biological impacts of nanoscale materials. EPA is exempting certain biological

materials, in part, because they do not exhibit different size-dependent properties in the size

range of 1-100 nanometers.

Other chemical substances, including as an example some chemicals that commenters proposed

that EPA exempt from reporting, such as pigments, polymers, and polymer dispersions, could be

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manufactured in nanoscale forms that both exhibit unique and novel properties and in forms that

do not. In the concept paper for the NMSP (Ref. 10), EPA stated that many polymers or

oligomers, particularly linear or planar polymers, should not be reported even though they have

dimensions in the nanoscale. Those polymers did not demonstrate size-dependent properties.

The paper did note that when conditions of polymerization or post-reaction processing create

free particles that fit the general description of “engineered nanoscale material” those chemical

substances should be reported under the NMSP. Please also refer to the comment and response

to comment 12 regarding the difference between enhanced and novel properties.

Comment 11: Several commenters also suggested a better definition of trace amounts, stating

that the term is not definitive and gives too much discretion to interpret compliance obligations.

The commenters suggested including a numerical value to define trace amount. Most

commenters did not suggest a specific value although one commenter noted the original

definition of the Agency’s draft proposed rule submitted to OMB would have required reporting

for those substances containing ≥10% particles in the range of 1-100 nm while another

commenter suggested using a numerical value of less than 10% of particles as trace amount that

would not be considered to be a reportable chemical substance. Commenters asked EPA to

clarify if particle size was to be determined by weight, volume, or count. One commenter stated

that EPA should not use weight based criteria to determine particle size as that measurement is

sometimes skewed by the inclusion of very large particles. Several other commenters suggested

using weight based criteria to identify particle size but did not give any reasons why.

Response: Chemical substances manufactured or processed at the nanoscale that contain

incidental amounts of particles in the size range of 1-100 nanometers are not reportable chemical

substances. EPA used trace amounts in the proposed rule to define this concept. However,

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based on the public comments to more clearly define trace amounts including several comments

to establish a numerical cutoff, EPA is instead using a numerical value of less than 1% of

particles from 1-100 nm by weight to more clearly define those chemical substances that would

not be reportable. EPA has chosen this number because it is the percentage cut-off used in

OSHA’s hazard communication standard for all chemicals substances that are not OSHA

carcinogens (for which there is a 0.1% cut-off) (Ref. 11). This 1% cut-off is a level that industry

has used to identify chemicals in safety data sheets (and previously in material safety data

sheets.) Industry is already using this cut-off to identify at least some nanoscale chemical

substances, e.g., carbon nanotubes in mixtures. EPA is using the weight based method for

measuring particles even though that measurement is sometimes altered by the presence of very

large particles because it is the most widely use method and more data will be available. The

final rule does not require reporting for any chemical substance where less than 1% percent of

the particle size distribution by weight is less than 100 nanometers.

Comment 12: Commenters noted that enhanced properties are not the same as unique and novel

properties and asked EPA to clarify the definition of enhanced property and replace it with

“novel” in section C.5. of the reporting form to be consistent with the definition of nanoscale

material.

Response: Enhanced properties are generally described as increased reactivity or surface area

when particle size decreases. While reactivity and surface area increase, there is often little

difference in the intrinsic properties of the particles in ranges above 100 nanometers. When

particles are created with dimensions in the 1–100 nanometer range, the materials’ properties can

change significantly from those at larger scales. EPA agrees that not all enhanced properties are

unique or novel. For example, grinding or engineering pigments for better performance which

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results only in incidental amounts of particles between 1-100 nm would not constitute a

nanoscale material with unique or novel properties. Grinding or engineering pigments for better

performance which results in almost all particles that are less than 100 nm would constitute a

nanoscale material with unique or novel properties. EPA will replace the word enhanced with

novel in section C.5. of the reporting form.

Comment 13: One commenter suggested that “EPA should use the same definition of

nanomaterials that was applied in the Nanoscale Materials Stewardship Program ("NMSP") to

identify the volumes and uses of nanoscale substances currently in commerce and then use this

information to identify those substances of concern for which the collection of data on those

materials is warranted” The commenter stated “such an approach by EPA would prevent

confusion and unnecessary reporting because of the vague terms and concepts of exhibit unique

and novel characteristics or properties because of their size."

Response: The NMSP did not define nanoscale materials. It described the types of chemical

substances that could be nanoscale materials and the types of chemical substances that generally

were not nanoscale materials. This approach would therefore be too vague for persons to

determine whether they are subject to the rule. Because it does not identify which chemical

substances are subject to reporting, EPA cannot use that approach for regulatory requirements.

Comment 14: One commenter stated that EPA should use the ISO TS 27687 definition of

nanomaterials for the definition of reportable chemical substance because it is an

internationally recognized definition of nanomaterials and distinguishes between two subgroups,

nano-objects and nanostructured materials.

Response: The ISO definition of a nanomaterial is a material with any external dimension in the

nanoscale or having internal structure or surface structure in the nanoscale. That definition

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would include chemical substances that were not manufactured or engineered for size-dependent

properties and contain particles greater than 100 nm. EPA’s definition of a reportable chemical

substance is not intended to include those types of chemical substances.

Comment 15: Several commenters asked EPA to clarify the objects and collections of objects to

which the 1-100 nm measurement applies. In other words does that mean any form with

particles 1-100 nm or does that include aggregates and agglomerates greater than 100 nm but

based on primary particles less than 100 nm?

Response: Chemical substances required to be reported would include any form with particles 1-

100 nm but would not include aggregates or agglomerates greater than 100 nm even if they

contain primary particles less than 100 nm. EPA has modified the description of particles that

would be subject to reporting in the definition of reportable chemical substance to better reflect

this understanding. The language in reportable chemical substance now reads. ”..where any

particles, including aggregates, or agglomerates.”

Comment 16: A commenter asked “Is it EPA’s intention to require reporting on large molecules

within the size range of 1 – 100 nm, which are not normally considered to be nanoscale

materials (for example, monomers, polymers, colloids, etc.). The commenter also asked “Are

polymers or metals attached to a ligands which are larger than 1 nm in size also considered a

nanoscale material for reporting.”

Response: In order to be a reportable chemical substance, the chemical must not only be a

particle in the size range of 1-100 nanometers. It must also have a unique or novel property,

which is any size-dependent property that varies from those associated with other forms or sizes

of the same chemical substance, and such property is a reason that the chemical substance is

manufactured or processed in that form. As described in the example cited in Comment 10, there

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are examples of monomers, polymers, and colloids that are not reportable chemical substances.

Large molecules and chemicals attached to ligands greater than 1 nm that do not meet the

definition do not need to be reported unless they form particles that meet the definition of a

reportable chemical substance.

Comment 17: One commenter stated that “We have experienced cases where the Chemical

Abstract Service (CAS) has not provided industry with a new registry number for a nanoscale

form of an existing CAS‐designed material. Will EPA provide guidance to industry in these

cases?”

Response: EPA will provide guidance to industry but it will focus on the definition of a

reportable chemical substance and the properties of the nanoscale material. CAS does not issue a

different CAS registry number for different nanoscale forms of the same chemical substance and

EPA does not use CAS registry number to identify different nanoscale forms of the same

chemical substance. Whether a CAS number is assigned or not will not affect whether a

chemical substance should be reported.

Comment 18: One commenter noted that “.. nanoscale materials larger than the arguably

somewhat arbitrary cut-off of 100 nm may also pose unique health or environmental concerns

compared to bulk substances. The same commenter stated “While we appreciate the pragmatic

need to establish specific size parameters for a Section 8(a) reporting rule, we encourage the

Agency not to limit itself to materials <100 nm as it works towards characterizing the risks of

nanoscale materials in the future.”

Response: EPA acknowledges that nanoscale materials greater than 100 nm may have different

properties unique to health or environmental concerns. For this rule, EPA chose the generally

accepted range of 1-100 nm to gather information on certain chemical substances in commerce

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as a starting point and will consider in the future potential risks from nanoscale materials greater

than 100 nm. EPA believes that using a specific generally recognized size range will result in

more useful data than if a less specific parameter were used. The commenter did not suggest an

alternative size range or other parameter to be used. EPA reiterates that 1-100 nm is a commonly

recognized size range for nanoscale materials.

Comment 19: A variety of commenters stated that EPA should add additional exemptions for

biological materials such as enzymes, lipids, carbohydrates, peptides, polypeptides, nucleotides,

liposomes, antibodies, viruses, virus-like particles, viral based products, organelles, and

microorganisms. The commenters stated that the additional biological materials should be

exempted for the same reason EPA proposed to exempt DNA, RNA, and proteins, that the

additional biological materials did not exhibit properties as a function of their size range.

Response: Because the other biological materials meet the same criteria that EPA identified in

the proposed rule, EPA is adding an exemption for enzymes, lipids, carbohydrates, peptides,

liposomes, antibodies, viruses, and microorganisms in the final rule. The properties of all the

exempted biological materials are not a function of the size range per se which can be in the

nanoscale but rather of the precise nucleotide sequence (in the case of DNA and RNA), shape,

and complex biological structures (living cells).

Comment 20: Several commenters identified additional possible exemptions for organic and

inorganic pigments and dyes because they are well understood or characterized and present low

risk and low potential for exposure. Commenters also stated that most organic and inorganic

pigments do not meet the definition of particles of 1-100 nm and a unique or novel property and

that some forms typically exist in the 1-100 nm range.

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Response: A reportable chemical substance is not just a substance containing particles in the size

range of 1-100 nanometers; it must also have a size-dependent property different from properties

at sizes greater than 100 nanometers. Organic and inorganic pigments and dyes could be

manufactured in nanoscale forms that both exhibit unique and novel properties andin forms that

do not. If a chemical substance does not exhibit unique and novel properties, then no reporting

would be required. EPA lacks information demonstrating minimal risk and exposure for

nanoscale forms of organic and inorganic pigments and dyes that would be subject to reporting.

EPA is not including an exemption for these chemical substances because it would exempt some

of the chemical substances at the nanoscale in commerce for which EPA is collecting

information on health and safety effects which would allow EPA to better assess and manage

risks of nanoscale materials.

Comment 21: Several commenters identified additional possible exemptions for polymers

including polymer dispersions because they are well understood or characterized and present

low risk and low potential for exposure. Commenters also stated that polymers and polymer

dispersions do not demonstrate a unique or novel property although they often exist in the 1-100

nm range. Commenters suggested that EPA include an exemption for polymers and polymer

dispersions to be consistent with the polymer exemption under section 5 of TSCA.

Response: A reportable chemical substance is not just a substance containing particles in the size

range of 1-100 nanometers; it must also have a size-dependent property different from properties

at sizes greater than 100 nanometers. Polymers and polymer dispersions could be manufactured

in nanoscale forms that both exhibit unique and novel properties andin forms that do not. If a

chemical substance does not exhibit unique and novel properties, then no reporting would be

required. EPA lacks information demonstrating minimal risk and exposure for nanoscale forms

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of polymers and polymer dispersions that would be subject to reporting. The polymer exemption

under TSCA section 5 is not based on whether the polymer is a chemical substance at the

nanoscale subject to reporting and does not include all polymers. EPA is not including an

exemption for polymers and polymer dispersions because it would exempt some of the chemical

substances at the nanoscale in commerce for which EPA is collecting information on health and

safety effects which would allow EPA to better assess and manage risks of nanoscale materials.

Comment 22: Several commenters identified additional possible exemptions for chemical

substances used in adhesives, coatings and sealants and chemical substances when they are

embedded in a polymer matrix or incorporated into a formulated product such as adhesives,

cement, ink, coatings, glass, paint, plastic and rubber. Commenters stated these types of

materials are well-understood or characterized and present low risk and low potential for

exposure. Commenters also noted TSCA section 5 regulations such as SNURs which exempted

requirements for carbon nanotubes, silica, and pigments when incorporated into polymer

matrices.

Response: Most of the activities described by commenters for exemption would only require

reporting for a reportable chemical substance before it is incorporated into a formulated product

or polymer matrix. Reporting would not be required by persons who use the formulated product

or polymer matrix. EPA lacks information demonstrating minimal risk and exposure for

formulated products or processing a chemical substance in a nanoscale form into a polymer

matrix. EPA is not including the proposed exemptions because they pertain to chemical

substances at the nanoscale in commerce for which EPA is collecting information on health and

safety effects which would allow EPA to better assess and manage risks of nanoscale materials.

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Comment 23: Several commenters proposed limited or no reporting for other nanoscale

materials such as carbon black, silica, titanium dioxide, and nanosilver based on the proposed

exemption for nanoclays and zinc oxide. The commenters asked EPA to better define the criteria

it used to exempt nanoclays and zinc oxide as well-characterized so that it could be applied to

these chemical substances. Several commenters also described the hazards and exposures of

these chemical substances as well-characterized. Several commenters stated that EPA should

not exempt zinc oxide and nanoclays as EPA had not identified and made available the data that

demonstrated why they are well-characterized.

Response: EPA has decided to not exempt nanoclays and zinc oxide from reporting. When

considering the comments to exempt other chemical substances based on its proposed exemption

for zinc oxide and nanoclays, EPA realized that it had given too much weight to the available

information on zinc oxide and nanoclays. While there is some available information on these

chemical substances, EPA does not consider the available information sufficient to extrapolate

this information to all other forms of these chemical substances to exclude information collection

under TSCA. Further, this limited information is not a sufficient basis to create a broader

exemption by analogy for other chemical substances. Thus, even for chemical substances

manufactured as nanoscale materials that could be described as a group as well-characterized or

demonstrating low hazard, EPA lacks information on how much and what type of specific

nanoscale materials are in commerce and what kind of information is available to assess the

properties that can impact health and safety and thus potential risks of those nanoscale materials.

The chemical substances that commenters and EPA stated were well characterized could be

manufactured in nanoscale forms that both exhibit unique and novel properties andin forms that

do not. EPA is not exempting from reporting any of the chemical substances proposed by

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commenters, including zinc oxide and nanoclays because doing so would exempt some of the

nanoscale materials in commerce for which EPA is collecting information on health and safety

effects which would allow EPA to better assess and manage risks of nanoscale materials. See

also the response to comment 25.

Comment 24: A commenter also suggested exempting nanocellulose because it was also as well

characterized as the chemical substances described in comment 23 and that available data for

commercial forms of nanocellulose demonstrate low hazard and risk.

Response: EPA is not exempting nanocellulose for the same reasons described in comment 23.

The type of information described by the commenter is the type of information EPA seeks to

collect, to identify nanoscale materials in commerce and to provide available information useful

in the assessment of those materials.

Comment 25: Several other commenters disagreed with exempting nanoclays and zinc oxide

from reporting because EPA did not give an adequate basis for exempting them and even if

current forms are well-characterized why exempt future new forms without information on those

new forms. One commenter gave an example of needing more information on new forms of zinc

oxide to address water quality issues from additional use.

Response: As noted in the response to comment 23, EPA will not finalize the proposed

exemption of zinc oxide and nanoclays. The rule will also require reporting of any new future

nanoscale forms of those chemical substances.

Comment 26: Some commenters proposed a volume cutoff below which no reporting is required

such as 10 or 100 kg.

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Response: EPA is not adopting a volume cutoff below which reporting is not required, in order

to obtain a better understanding of nanoscale forms of chemical substances in commerce

including those with high added value but low production volume. One time gathering of

information on even low volume nanoscale materials could result in data relevant to their

environmental and health effects.

Comment 27: Several commenters stated that EPA should exempt naturally occurring or mined

nanoscale materials. One commenter noted that CDR regulations exempt naturally occurring

chemical substances as described at 40 CFR § 710.4(b). Several commenters also stated

naturally occurring nanoscale materials should be exempt from reporting as they do not meet

the criteria of the definition of “manufactured or processed.” Another commenter suggested

limiting reporting to engineered nanomaterials as they are “generated for a specific function”

or “deliberately manipulated.”

Response: EPA did not exempt naturally occurring materials or limit reporting to chemical

substances engineered at the nanoscale because some of these chemical substances meet the

criteria of a reportable chemical substance and some of them do not. These chemical substances

must be reported only if they meet the definition of containing particles in the size range of 1-

100 nanometers and a size-dependent property different from properties at sizes greater than

100 nanometers. EPA expects that reportable chemical substances would usually be the result

of processing of naturally occurring or mined materials by manufacturers and processors

Comment 28: A commenter stated that EPA should add an explicit exemption for nanoscale

substances that are unintentionally generated during manufacturing and processing. Another

commenter asked EPA to clarify if it matters if a nanoscale substance is intentionally added

versus accidentally formed.

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Response: If a nanoscale chemical substance is unintentionally generated or added and not

intended to be part of the commercially manufactured or processed chemical substance, it may

be considered a byproduct or impurity and would be exempt under 40 CFR 704.5(b) or (c). If a

nanoscale chemical substance is unintentionally formed but is considered to be part of the

function of the commercial product, it would be a reportable chemical substance. There are

examples where a chemical substance is intentionally produced, but unintentionally produced at

the nanoscale, and the manufacturer knows that it contributes to the function of their product. In

those cases, where a company knows about its functionality, the chemical substance is still

subject to TSCA reporting requirements. See, for example, EPA's PMN regulations at 40 CFR

720.30(h)(2), which exempts from reporting a byproduct not used for commercial purposes, but

retains the reporting requirement if the byproduct is used for commercial purposes. The rule

does not require a company to determine the functionality of every impurity or byproduct. A

company is required to report that chemical substance when it knows the chemical substance has

commercial functionality.

Comment 29: Several commenters asked EPA to clarify the exemption for chemical substances

manufactured at the nanoscale as part of a film on a surface. EPA should more clearly

differentiate the nanoscale structures in semiconductor devices from the discrete nanoscale

materials that are reportable under the rule and that the exemption should state …”chemical

substances manufactured or processed at the nanoscale as part of a film on a surface” because

forming these types of film are often considered processing and not thought of as manufacturing.

Two commenters also suggested that EPA include specific techniques in the definition to make

clear it is the nanoscale film less than 100 nm that is exempt. The commenters stated “To

achieve these refinements, the commenter recommends that the exemption language at 704.20(c)

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(1)(iii) be worded as follows: “Chemical substances manufactured or processed at nanoscale as

part of a film on a surface, utilizing vapor or atomic layer deposition, ion implant, sputtering,

diffusion, plating, spin‐on processing or other deposition technique.” This would help to clarify

that the key to the exemption is the application of chemical substances to a surface “as part of a

film,”

Response: As noted by the commenters who suggested modified language for this exemption, in

many applications films less than 100 nm can be formed over a wide variety of surfaces. In

some cases, these films can be formed even though the chemical substances used to form the

film are not nanoscale materials. The purpose of the exemption is not to require reporting on

films on a surface because those films do not exhibit size-dependent properties. In those

instances where the chemical substances that are used to form a film on a surface are nanoscale

forms subject to reporting under the rule, the manufacturer or processors would report that they

are used to form a film on a surface. EPA is not including the language regarding techniques

suggested by commenters because it does not want to limit or suggest the exemption is limited to

specific techniques. The exemption is directed to a chemical substance formed as a film

regardless of technique. Because “chemical substances manufactured at the nanoscale as part of

a film on a surface” did not adequately describe the films on a surface exemption that was

proposed and may also confuse manufacturers or processors who form a film using nanoscale

chemical substances, EPA will change the wording of the exemption to state “chemical

substances formed at the nanoscale as part of a film on a surface.”

Comment 30: Several commenters suggested that EPA not exempt chemical substances

manufactured at the nanoscale as part of a film on a surface to obtain more data as it emerges.

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The commenters either gave no explanation or assumed EPA’s basis was low exposure and

noted the potential for exposure from the constituents of films or coatings.

Response: While the rule does exempt chemical substances manufactured at the nanoscale as

part of a film on a surface, EPA will nonetheless receive information on reportable nanoscale

materials that are used to manufacture chemical substances at the nanoscale that are incorporated

into such a film.. When EPA reviews the reported information the Agency can evaluate the data

from that commercial activity.

Comment 31: Several commenters stated that EPA cannot require information that violates the

language under the Toxic Substances Control Act (TSCA) § 8(a) prohibiting “any reporting

which is unnecessary or duplicative.” Commenters stated that requiring reporting of some of

the information already reported to the NMSP would be duplicated especially the large amount

of health and safety information submitted for broad classes of chemical substances such as

silica and carbon black. Commenters also asked EPA to explain why the proposed reporting

requirements do not duplicate reporting required under CDR.

Response: The reporting required by this rule does not duplicate reporting EPA would receive

under other TSCA regulations. Chemical data reporting (CDR) under 40 CFR part 711 does not

require manufacturers to distinguish reporting for different forms of chemical substances

including nanoscale materials. This rule also exempts reporting for chemical substances that are

nanoscale materials that have already been reported under section 5 of TSCA since 2005 except

for new discrete forms. As noted in the interim report on the NMSP (Ref. 12), EPA received

limited reporting on nanoscale materials in commerce. The reporting for nanoscale materials

such as silica and carbon black gave an overview of the entire industry but not information on

individual nanoscale materials. A company reporting a silica or carbon black-based nanoscale

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material does not have to resubmit the information submitted under the NMSP. However, any

reporting of silica or carbon black nanoscale materials would need to include any health and

safety information that company possesses for the specific nanoscale material it is reporting. As

already noted, CDR reporting does not distinguish between different nanoscale forms of

chemical substances. Several commenters stated that EPA needs more information on nanoscale

materials in commerce. EPA addresses more specific comments about information required by

the rule in other response to comments.

Comment 32: Several commenters noted that processors do not know about the particle size and

other characteristics of formulations they process or use and should not be required to report.

Response: Reporting of information under TSCA section 8(a) is required only to the extent the

information is known or reasonably ascertainable, and includes information that the

Administrator may reasonably require. This standard applies both to the extent of an entity’s

obligation to determine whether it is required to report, and to the extent of information any

entity is required to report. If processors do not know about specific physical properties of

chemical substances, they must still take reasonable measures to ascertain the information that

would determine whether they are subject to the rule. If processors do not know about specific

properties such as particle size and other properties that would allow them to know if they are

processing a chemical substance subject to the rule, it would be within the reasonably

ascertainable standard to ask their suppliers for information that would enable to processor to

determine whether the supplier is selling them a nanoscale material subject to reporting and if so

provide them with what reportable information they have. Their supplier is not required to

provide any additional information to the processor but might provide other supporting

information, for example, whether their supplier has reported or intends to report the chemical

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substance under this rule. If the supplier provides information indicating that the substance is not

reportable or if the processor lacks any other means of reasonably ascertaining whether the

substance is reportable, the processor does not need to perform tests to determine whether the

substance is reportable. Information developed in the normal course of business or that the

processor chooses to develop must also be used. The processor may want to document the steps

they took to determine if reporting was required. Companies that purchase formulations but do

not change or modify those formulations and only use them are not considered processors and

are not required to report.

If the information provided by the supplier indicates that reporting is required, the

processor is required to report information that is known or reasonably ascertainable, which may

include information obtained from the supplier. This would include situations where the

processor may not know the exact chemical identity or some of its physical properties.

The obligations imposed by the reasonably ascertainable standard are discussed more

fully in the Chemical Data Reporting final rule, 76 FR 50816, 50829 (August 16, 2011),

Comment 33: Several commenters asked EPA to clarify if manufacturers and processors are

only required to report available or reasonably ascertainable information does this mean they

need to develop information to comply with the rule. Other commenters asked EPA to clarify if

manufacturers and processors need to develop information to comply with the rule.

Response: Manufacturers and processors are not required to conduct testing or develop

information under this rule. However, they are required to report information that is known or

reasonably ascertainable.

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Comment 34: Several commenters objected to imposing the same reporting requirements on

both processors and manufacturers stating that some processors will not be aware of

information known to manufacturers such as for example chemical identity, physical-chemical

properties, byproducts, impurities, health effects data, and general population exposure. In

addition, the commenters speculated that processors may report uses and processes already

reported by the manufacturer. The commenters felt the reporting requirements place

impractical or burdensome obligations on processors without collecting information that would

serve the intended purposes of the rule when manufacturers were in the best position to report

information required by the rule. Commenters suggested limiting reporting to only

manufacturers or limiting the information to be reported by processors.

Response: Processors are only required to submit information that is known or reasonably

ascertainable. In addition, processors may have access to pertinent information that

manufacturers do not have access to. Processors can often describe in greater detail how the

nanoscale material is processed and used and any characteristics that change because of

processing. Details on the processing and use of nanoscale forms of chemical substances with

unique or novel properties will give EPA a better understanding regarding how to assess those

chemical substances and whether any further actions are warranted under TSCA.

Comment 35: One commenter noted that OSHA does not require particle size information and

asked if EPA will work towards mandating reporting of this information to customers.

Response: EPA would encourage manufacturers to inform their customers if they distribute a

chemical substance subject to reporting for this rule so their customers would know they are also

subject to reporting.

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Comment 36: A commenter asked if processors of a chemical submitted as a PMN are required

to report. Another commenter stated that all manufacturers and processors should be exempt

from reporting for a chemical substance already the subject of a section 5 submission, not just

the original submitter.

Response: Only persons who submitted the section 5 submission after January 1, 2005 are

exempt from reporting. Other manufacturers and processors would still be required to report.

The additional information they would have on details of manufacture, processing, and use

would not be duplicative reporting because that information would not be reasonably

ascertainable by the PMN submitter.

Comment 37: A commenter asked if a nanoscale substance is reported as a new chemical for one

use but later has a different use from the one reported, would this require section 8(a) reporting.

Because this rule includes one-time reporting of nanoscale forms of chemical substances in

commerce, new uses of reportable chemical substances do not require additional reporting.

However, if the person manufactures or processes a discrete form of the reportable chemical

substance then that person would be required to report under this rule.

Comment 38: A commenter asked if “reporting for mixtures is notifier-specific or substance-

specific. For example if a manufacturer reports and sells to 10 processors, does each customer

report?”

Response: Reporting for mixtures is not required but is required for a reportable chemical

substance in a mixture. Any reportable chemical substance that is incorporated into a mixture or

substrate would require reporting for manufacturing or processing of that chemical substance. If

a manufacturer sells a mixture containing a reportable chemical substance to multiple processors

then each processor is also required to report.

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Comment 39: A commenter asked “would each manufactured material containing the

nanoparticles throughout this supply chain all the way to the end use need to be separately

reported, or would reporting of only the primary discrete nanoparticle need to be reported at the

point of manufacture to avoid redundant reporting of the same primary material?” The

commenter also asked if this includes incorporation into articles and substrates.

Response: Each manufacturer and processor in the supply chain would need to report reasonably

ascertainable information on how the nanoscale form of the chemical substance is manufactured,

processed or used throughout the supply chain. The additional information they would have on

details of manufacture, processing, and use would not be duplicative reporting because that

information would not be reasonably ascertainable by the manufacturer. Once a chemical

substance has been incorporated into an article, no further reporting is required as persons that

manufacture or process chemical substances as part of articles are exempt from reporting.

Comment 40: One commenter stated that EPA has publicly expressed misgivings about the value of

processor reporting under TSCA. In March 2013, the Government Accountability Office issued a

report on the TSCA program that recommended issuance of a Section 8 rule requiring reporting of

exposure-related data by chemical processors. The GAO report includes a letter from EPA

responding to this recommendation. EPA questioned the value of processor data, noting that

“processors” are not always end-users of products, and that end-users “often have little exposure-

relevant data.”

Response: Because this rule focuses on chemical substances manufactured as nanoscale materials with

unique and novel properties, processors are expected to have information on whether those nanoscale

materials are handled differently than other chemicals or if the nanoscale materials have any

additional characteristics because of processing details not known to manufacturers or end users.

This rule does not require reporting from end users unless the end users are also processors.

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Comment 41: Some commenters noted how the CBI interests of downstream companies that

supply confidential information to manufacturers may not be protected when manufacturers

provide that information as part of their reporting but do not claim the information as

confidential.

One of the commenters stated that “The form that would be required under this proposed rule

seeks highly detailed information from chemical suppliers about what they may know about their

customers’ businesses, technologies and operations. Unintentional public release of the

intellectual property of customers would result in severe and substantial economic impacts to

U.S.-based industry. The current CBI protection provisions in 40 CFR Part 704 and Part 2,

were not designed with a scenario like the Nano Reporting Rule in mind and thus should be

upgraded to protect the reasonable interests of downstream companies.” One commenter

suggested procedures for addressing this issue such as EPA could review information regarding

Industrial Sites Controlled by Others and on the Lifecycle Overview on the proposed reporting form.

“In conducting this review, EPA could also take into consideration the number of facilities that the

reporter is characterizing (which would be identified on page 11) to determine whether the

information reported is characterizing specific facilities or a more generalized description of a

downstream industry. Looking at the specific entries on these few pages, EPA would determine

whether a CBI claim “could be expected” by an affected business if that business knew that the

information on these pages would be publicly disclosed.” Other commenters stated that “EPA

should also include in the form instructions a statement that reporters should consult with their

customers on these sections of the form and an explanation that reporters should assert CBI

claims for information that they expect to be considered CBI by their customers.”

Response: While 40 CFR 2.204(c)(2)(i) requires EPA to make an inquiry regarding CBI claims

when “a company might be expected to assert a claim if it knew EPA proposed to disclose the

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information,” EPA is generally not in a position to speculate concerning CBI claims that might

be asserted by downstream or upstream companies. Therefore it is properly up to the businesses

involved to communicate regarding confidentiality. Once information has been received and not

claimed as confidential, it may be difficult if not impossible to protect it. EPA will add language

to the form instructions that “You may want to consult with your customers or suppliers about

the confidentiality of any information you report about them on this form.”

Comment 42: There were numerous comments to not include the 135 day reporting requirement

for new discrete forms. This requirement was characterized by several commenters as de facto

new chemical reporting. The commenters noted it is burdensome, would adversely affect

commercialization and was arbitrary as reporting before commercialization of an existing

chemical was not part of TSCA 8(a) authority. One commenter stated EPA should give a risk-

based explanation for the proposed reporting. Numerous commenters stated EPA should make

clear when commercialization can begin – for example after notification to EPA or after 135

days. Commenters offered alternatives such as 60 days before commercialization or up to six

months after commercialization. The 135 day reporting requirement was supported by several

commenters who stated it would allow EPA time to evaluate the reported nanoscale materials

and take any necessary actions under TSCA.

Response: EPA did not intend to create de facto new chemical reporting for new discrete forms

of nanoscale materials, because the 135-day period is not a formal review-period that prohibits

manufacture before the end of the 135-day period. Rather, based on EPA's experience with the

Premanufacture Notice (PMN) program, EPA believes that in most cases companies have the

requisite intent to manufacture or process at least 135 days before manufacturing or processing

will begin, and the rule requires reporting based upon this presumed intent. However, if a

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company does not form the requisite intent 135 days ahead of time, the company must report

within 30 days of the formation of such an intent. Moreover, if a company desires to begin

manufacture or processing less than 135 days after the submission for this rule is made, the

company is free to do so. There is no obligation upon the company to wait 135 days after

reporting to manufacture or process. EPA is revising the language in 704.20(f)(2) to clarify that

the rule does not prevent manufacturing before the 135-day period has passed. If the company

changes its schedule or does not form the intent until a later time, it may wish to document

supporting facts.

Further, the comments made EPA realize that the regulatory text as written in the

proposal created a result unintended by the Agency (and not commented upon): because (1) the

default period of 135 days is greater than the advance of periods required for various section 5

submissions, and (2) the reporting exemption for section 5 submissions in 704.20(c)(2) of the

proposal would apply only where the company had already filed a section 5 submission, a

company proposing to manufacture a discrete form of a reportable substance for which a section

5 submission had not been filed might conceivably be required to first file a section 8(a) report,

followed by a section 5 submission. In such cases EPA only needs the section 5 submission, and

sees no value in the additional burden of requiring a duplicative section 8(a) submission.

Therefore EPA is adding a new subcategory of non-reportable chemical substances to 704.20(c)

(1), for chemical substances that are not on the TSCA Inventory at the time reporting would

otherwise be required, to clarify the Agency’s original intent in the NPRM. If a reportable

chemical substance is not on the TSCA Inventory a manufacturer only needs to submit a new

chemical notification under section 5 of TSCA.

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Comment 43: Several commenters stated that the reporting requirement for discrete forms of

existing chemicals is not reasonable or necessary. One commenter stated that “The proposed

reports and 135 day waiting period with no sunset, for an entire class of emerging technology,

would establish a notification program for existing chemicals that takes longer, and is more

burdensome, than for new chemical substances under section 5.” The commenter stated that it

“does not agree with EPA’s determination that this aspect of the proposal is consistent with

existing Administration policy, and urges its withdrawal entirely” and that “has reviewed EPA’s

existing guideline for reporting nanoscale substances to the TSCA Inventory, and two policy

statements issued by the White House Office of Science and Technology Policy. These policy

statements have concluded that the U.S. regulatory framework as it exists today is sufficient to

regulate nanomaterials.”

Response: As described in the response to comment 42 the reporting requirements in this rule

serve only as a reporting program and do not regulate commercialization of existing chemical

substances. As described in the response to comment 1, reporting requirements for discrete forms

of chemical substance is consistent with TSCA section 8(a) authority. The reporting

requirements for discrete forms of reportable chemical substances will allow EPA to gather

additional information on nanoscale materials in commerce when it becomes available and to

determine if any further actions under TSCA are necessary.

Comment 44: Several commenters stated EPA should allow more time for companies to report

chemical substances in commerce. One commenter stated “we don’t have enough time to

prepare the report especially for first period (six months) because preparing the report will be a

time consuming process for the company manufacturing several types of nanoscale materials.”

In order for any new reporting requirements of this rule not to coincide with reporting

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requirements of the 2016 CDR rule another commenter suggested “that any reporting obligations

under this rule commence no earlier than September 30, 2017, one year after the 2016 CDR data

reporting period closes”

Response: Based on these comments, EPA will extend the period to report chemical substances

in commerce to one year after the effective date of the rule. This will allow companies time to

familiarize themselves with the new reporting requirements and to comply with requirements if

they have multiple reportable chemical substances. It will also ensure that the reporting

requirements of this rule do not coincide with the 2016 CDR reporting.

Comment 45: There is not standardized testing for the physical properties in the proposed rule

identified for manufacturers and processors to determine if they qualify for the rule. EPA should

identify test methods to be used to comply with the rule. Many processors will not know to test

for these properties. EPA cannot require this testing until validated protocols are developed.

Response: Testing or developing new information is not required by the rule. Only known or

reasonably ascertainable information needs to be reported. Companies are only required to

report on known or reasonably ascertainable information. See the response to comment 3 for

guidance as to situations in which a company does not know about the physical properties

identified in the regulation. In the proposed rule, EPA supplied examples of testing guidelines

that could be used for these types of properties should the company desire to do such testing.

Comment 46: Commenters asked EPA to either reevaluate or justify the use of seven standard

deviations as the numerical change in property values to determine the discrete form of a

reportable chemical substance. One commenter stated that “The scientific basis for the use of

seven standard deviations as a cutoff for reporting is not presented in the proposed rule.

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Therefore, it should either be justified or supplanted with a justified cut-off. The use of standard

deviation as a measure of confidence in statistical conclusions is generally useful. It is assumed

that the measured value is the mean of the values measured, although this is not stated. Also, is

this cut-off of seven times the standard deviation for physicochemical values assumed to be

based on a normal distribution?” One commenter stated EPA should reconsider seven times the

standard deviation as the numerical change in property values to determine the discrete form of

a reportable chemical substance because “This approach sets a very high bar: It would not only

require potentially very large changes in size/properties to trigger new reporting, but it would

also exclude from reporting even very large changes in size unless accompanied by a large

change in properties – and vice versa.”

Response: The standard deviation is a measure of how spread out a distribution of values are, in

this case particle size distribution. EPA is continuing to use seven standard deviation as it allows

for natural variations in change for variable materials such as nanoscale materials. When

determining to use seven standard deviations, EPA attempted to balance how much variation to

allow for discrete forms of a reportable chemical substance and whether companies have the

analytical tools to make such distinctions. Using this approach permits materials with wide or

narrow ranges of variability to be treated in the same proportion. Unless the physical property

measurement already contains a measured mean and a distribution based on multiple

measurements such as a particle size distribution, the mean should be assumed to be the

measured value and a normal distribution should be assumed.

Comment 47: There were several suggestions to better align reporting with Canadian

nanoscale materials reporting such as only identifying specific substances for reporting, only

have manufacturers and importers report, the quantity and scope of materials covered, information to

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be reported and subsequent reporting requirements. One commenter stated “… if the U.S. and

Canadian approaches are not more closely aligned, the comparability of information and ability

to move forward in a coordinated manner would be at risk and that the reporting burden on

industry could be extremely high.” Another commenter stated “The reporting burden on

companies that are required to report to both governments will be extremely high unless the U.S.

and Canadian approaches are aligned.”

Response: The commenters did not identify a specific reason why not aligning the proposals

would be unduly burdensome other than the US approach required more information on more

nanoscale materials for a longer period of time, nor did they suggest a way to align the different

approaches. EPA believes the approach it has taken is consistent with the intent of TSCA and

believes an alignment solely for purposes of alignment would be arbitrary. Because these rules

were developed under different statues and review processes, EPA and Canada were unable to

make additional changes to align the rules as they were being developed, proposed, and

finalized. EPA will continue to work with Canada to align, where appropriate, any additional

information gathering or risk management activities.

Comment 48: One commenter asked EPA to enable submitters to authorize EPA to share CBI

provided under this rule with Environment Canada and Health Canada.

Response: In order to continue work on sharing available information and to inform future

alignment on activities pertaining to nanoscale materials, EPA will include in final rule the

option to share information with Canada. As suggested by the commenter the reporting form

will include the option to authorize sharing of all CBI information with Environment and

Climate Change Canada and Health Canada. Any shared CBI would be subject to the CBI

protection policies of those agencies.

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Comment 49: Several commenters supported the existing $4 million dollar small business

exemption. Because of the uncertainty of hazards for nanomaterials, one commenter wanted a

smaller dollar amount so that more small businesses would be required to report. Other

commenters stated it should be increased to $9.5 million dollars to account for inflation since

1988 when the current small business amount of $4 million was established.

Response: Based on these comments and updated economic information, EPA is changing the

definition of small business in the final rule to include any company with sales of $11 million

dollars or less. In suggesting EPA change the value to $9.5 million, the commenter assumed the

original $4 million was promulgated in 1988. However, the $4 million was initially promulgated

in 1984 (49 FR 45425) with a base year of 1983. Therefore, it is appropriate to inflate the $4

million from $1983 to $2015. When accounting for inflation since 1983, EPA calculated the

figure to be $11 million dollars.

In proposing this definition, EPA provided notice and comment on the criteria for small

manufacturers and processors subject to this rule, and consulted with the Small Business

Administration (SBA) in accordance with TSCA section 8(a)(3)(B). EPA’s change to this

definition is consistent with both public comments and the feedback we received from SBA.

EPA recognizes that recent amendments to TSCA include a new and separate obligation under

amended TSCA section 8(a)(3)(C), which requires EPA, after consultation with the SBA, to

review the adequacy of the standards for determining the manufacturers and processors which

qualify as small manufacturers and processors for purposes of TSCA sections 8(a)(1) and 8(a)

(3). TSCA furthermore requires that (after consulting with the SBA and providing public notice

and an opportunity for comment) EPA make a determination as to whether revision of the

standards is warranted. In the Federal Register of December 15, 2016 (81 FR 90840) (FRL-

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9956-03), EPA sought public comment on whether a revision of the current size standard

definitions is warranted at this time; announced EPA’s initiation of the required consultation

with the SBA, and provided its preliminary determination that revision to the currently codified

size standards for TSCA Section 8(a) is indeed warranted. As part of this effort, EPA will review

the adequacy of the standards for small manufacturers and processors in existing TSCA section

8(a) rules, including this one. Any changes resulting from the assessment will undergo

consultation with SBA and will be proposed for notice and comment as required by TSCA

section 8(a)(3)(C).

Comment 50: One commenter stated that “EPA also should implement a different, higher

annual sales figure for small business processors in this rule” because “sales of the processed

product can result in annual sales figures that will easily exceed the proposed small business

threshold of four million dollars for an otherwise small business processing operation.”

Another commenter objected to the change eliminating the production volume limit for the small

business exemption suggesting to exclude producers of very small amounts because “The fact

that nanomaterials may only be processed in small volumes points to the fact that the potential

for exposure to man or the environment still remains low for these materials.”

Response: As explained in the proposed rule, EPA does not believe that the production volume

of chemical substances manufactured or processed as nanoscale materials is the most relevant

consideration for defining the small business exemption for the rule, because many nanoscale

chemical substances manufactured or processed in small volumes. For the same reason, EPA

would not consider it relevant to consider only nanoscale chemical substance sales or a different

sales figure for a processor to identify what is considered a small processor exempt from the rule.

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Comment 51: One commenters stated that the definition of small manufacturer or processor

should be consistent with the Small Business Administration (SBA) definitions based upon its

analysis of sectors impacted, sales and employment.

Response: EPA consulted with the SBA on factors to be included in the definition. SBA’s

response is included in the docket. The only suggestion from SBA was to increase the sales

figure based on inflation to a higher number around $9.5 million. As discussed in Comment 49,

EPA chose a figure of $11 million in the final rule. The other considerations of sustainability,

sectors impacted, and employment do not greatly affect whether a company is considered a small

manufacturer or processor because they do not have measurable impact on the total sales of a

company.

Comment 52: Several commenters stated that EPA has underestimated the number of affected

entities and the number of discrete forms of nanoscale materials that individual companies may

have to report and the burden associated with that reporting. One commenter stated that in the

references cited by EPA in its economic analysis “There is no mention of large scale additives

or legacy products of any kind. In particular, there is no mention of color pigments” and

“EPA’s description and estimate of the size of the regulated community indicates that EPA could

not possibly have intended to include millions of pounds of color pigments or the thousands of

companies which manufacture and use color pigments in inks, paints, plastics, ceramics, cement

and other industries.” Another commenter stated that “…members have anecdotally mentioned

that they may have dozens or more potentially reportable discrete forms of nanoscale

substances, not the approximately 5 per company estimate in the EPA’s economic analysis of the

Proposed Rule. A commenter also stated that the data used to develop EPA’s estimates of

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number of affected entities is outdated. Commenters stated cost estimates should be adjusted

based on these considerations and the broad scope of the rule.

Response: EPA’s analysis for the proposed rule evaluated several sources of data to estimate the

number of companies affected by the rule, including BCC Research’s report: Nanotechnology: A

Realistic Market Assessment (2008). Since the proposal, BCC released an updated report (2014)

which EPA used to recalculate its estimate for the number of nanoscale material companies

following the same methodology as in the proposal. EPA found that there was no significant

difference in the estimated number of nanoscale material firms using the updated information

(there was actually a slight decline) and therefore, finds its estimate of nanoscale material firms

to be a reasonable estimate of those affected by the rule. Previous comments clarifying the

definition of a reportable chemical substance, trace amounts, and that every use of a formulation

would not require separate reporting should make it clear that reporting of every legacy product

such as color pigments would not be required, and EPA expects that reporting would be required

for very few. EPA recently reviewed premanufacturing notices (PMNs) for pigments and dyes

submitted to the Agency for fiscal years 2014, 2015, and 2016 (fiscal year 2016 ended May 31,

2016) and found that of the 179 PMNs submitted, 70 submitted information on particle size

(particle size is not required to be reported). Of those 70, only 1 pigment/dye would be of a size

(<100 nm) that would be reportable under this rule, although it is not known if that pigment/dye

would have met all other criteria which would make it subject to reporting. Commenters

provided no additional data or specific references which EPA could use to further assess the

likelihood or number of pigments requiring reporting.

EPA disagrees with those commenters who argue that EPA’s estimate of the number of

reportable nanoscale materials per firm are underestimated, providing no more than an anecdotal

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mention that companies may have more reportable nanoscale substances (“may have dozens or

more”) than estimated by EPA, stating that companies had an uncertain understanding of the

proposed definition of discrete forms. EPA has provided more clarification on definitions (e.g.,

responses to comments 10, 11, 12) to address uncertainty in what is a reportable substance.

EPA’s estimate of number of reportable nanoscale materials represents an average across firms,

therefore, any particular firm may have fewer or more materials that it must report. Because the

information is anecdotal, it is not clear what the basis of the commenter’s estimate is. EPA’s

estimate reflects an annual number of reportable nanoscale materials per year and includes

consideration that at any one time, a firm may have a number of nanoscale materials that may be

in various stages of development, including R&D and commercially relevant materials. Because

the rule provides an exemption for nanoscale materials being used for R&D, these are not

included in EPA’s estimate of reportable substances. It is not clear if the commenter’s anecdotal

information excludes these materials. EPA’s estimate of number of reportable nanoscale

materials represents an average across firms, therefore, any particular firm may have fewer or

more materials that it must report. Furthermore, to evaluate the effect of different estimates of

the number of reportable substances per company, EPA has also developed a sensitivity analysis

which evaluated a range of reportable substances per firm during the first year from .39

(implying fewer than one nanoscale material per year over the time frame of the analysis) to

25.67 which is included in the economic analysis. Commenters did not provide specific

references or data that would allow EPA to further revise its analysis on the basis of the number

of reportable nanoscale materials.

Comment 54: A commenter stated that EPA lacked quantitative data for its regulatory flexibility

analysis finding for processors, and should identify data for processors and conduct an

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economic analysis using that data. The commenter also stated that “Small businesses have

expressed concerns that some processors may not have the regulatory sophistication or

personnel to comply with the reporting requirements. As a result, these small businesses will

incur the cost of third party training and other professional assistance. Such additional costs are

not included in the agency's EA. In addition, the agency has not considered other important cost

factors in the EA such as the time and effort required to acquire, review and analyze the relevant

information to determine whether a material meets the reportable criteria and whether or not a

reporting obligation exists. In many cases, processors may not have the information and have to

take additional steps to obtain the information from their suppliers or manufacturers. This may

prove to be particularly burdensome for small processors with limited resources.” Based on

this EPA should recognize the different, potentially higher administrative costs for processors

and conduct an economic analysis on that basis.

Response: Notwithstanding this comment, EPA believes that the reporting burden per reportable

substance is the same for all entities reporting under the rule and does not include different

burden estimates for manufacturers and processors. The information required by this rule must

only be reported if it is known to or reasonably ascertainable by persons subject to the rule. This

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, know, or obtain (the

rule does not require companies to develop information).

EPA’s estimate of burden does include an estimate for completing all required information

elements. For some companies reporting on certain materials, it is possible some information

fields may not be known or reasonably ascertainable so that EPA’s estimate may overestimate

the costs for some reports. Furthermore, EPA does not expect that a processor would need to

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incur third party training or other professional assistance in order to provide reasonably known or

ascertainable information. What constitutes known or reasonably ascertainable may differ across

business types and sizes such that what may be reasonably ascertainable for one business, for

instance, a large manufacturer with more available resources, may not be the same for another

business, such as a small processor with limited resources. Regardless, EPA has provided an

exemption from the rule for the smallest businesses involved with manufacturing and processing

nanoscale materials (those with less than $11 million is sales) who may have more limited

resources.

Not only are companies required to report only that information which is known or reasonably

ascertainable, but companies, including processors, need only use information that is in their

possession or which is reasonably ascertainable to determine their compliance obligations under

the rule. Therefore, processors and are not expected to incur a significant burden for compliance

determination.

Comment 55: One commenter stated that “EPA should apply its annual growth rate

methodology to its estimate of the regulated community (described in section 2.2.4 of the EA)

and recalculate subsequent analyses based on this consideration to more accurately reflect

industry growth over time. Assuming EPA adopts the recommendation to apply the annual

industry growth rate methodology used in its sensitivity analysis to its broader EA, EPA should

amend its calculations to reflect the correct denominator (number of years). This recalculation

would increase the total number of firms impacted by this rulemaking, including, potentially, the

number of small firms affected.

Response: In EPA’s original analysis, it assumed no growth in the number of regulated entities

over time, however, provided a sensitivity analysis incorporating a growth rate to evaluate the

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effect of an increased number of firms subject to reporting over the time frame of the rule. The

commenter suggests that EPA incorporate this growth rate in its main analysis and make a

correction to the estimated growth rate based on a revised calculation. To determine whether to

incorporate the growth rate into the main analysis, EPA reviewed the estimated number of firms

manufacturing nanoscale materials and subject to the rule in its original analysis and compared it

to an estimate using more recent data to evaluate the growth in the industry. EPA’s original

analysis relied primarily on a 2008 market study to estimate the number of U.S. nanoscale

material manufacturers subject to the rule. EPA reviewed a 2014 version of the same study and,

following the same methodology, found little change (actually a slight decrease) in the number

of estimated nanoscale material manufacturing companies in the U.S. that would be subject to

the rule, supporting EPA’s assumption of no growth in the overall number of nanoscale material

firms.

EPA did, however, revise the growth rate in its sensitivity analysis to correct for an error

identified by the commenter.

Comment 56: Several commenters suggested that EPA should better define particle.

One commenter stated “The word “particle” is not a term with specific meaning. It is critical

that EPA is clear about the definition of “particle” so that companies understand what materials

require reporting. For example, does the term “particle” include solid objects that contain

internal crystalline domains at the nanoscale? Does it include dispersions, suspensions, or

aerosols? A definition of “particle” would provide an important starting point for determining

whether a material is subject to reporting. It should take into account the ability of a “particle”

to move freely in its environment.”

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Response: EPA will use the definition of particle from ISO which is a “minute piece of matter

with defined physical boundaries.” The notes to the ISO definition may assist in applying this

definition. Note 1: A physical boundary can also be described as an interface. Note 2: A particle

can move as a unit. EPA is using this definition because there is international agreement on the

definition and it addresses the commenter’s questions about the ability of a particle to move in

the environment and that it could include dispersions, suspensions, or aerosols.

Comment 57: Because the preamble to the rule stated that a reportable chemical substance

contained particles 1-100 nm in at least one dimension but the proposed regulation did not

specify the number of dimensions, several commenters suggested that EPA clarify the number of

dimensions for particles of 1-100 nm that are required for nanomaterial to be a reportable

chemical substance.

Response: Chemical substances that contain particles that are 1-100 nm in at least one dimension

are considered reportable chemical substance. EPA has changed the definition of reportable

chemical substance in the final rule to state that particles must 1-100 nm in at least one

dimension.

Comment 58: Several commenters asked for clarification of the criterion to exclude chemical

substances that dissociate completely in water to form ions that are smaller than 1 nm. The

commenters asked how fast or what the rate of dissociation would be.

Response: The rate of dissociation or how fast that dissociation occurs does not affect which

chemicals are excluded. If the chemical substance completely dissociates to form ions smaller

than 1 nm it is not a reportable chemical substance.

Comment 59: Several commenters stated that the shape criteria for identifying reportable

chemical substances are too vague and unworkable. The commenters asked what the criteria

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are to discern one shape from another. For example one commenter stated “For morphology,

how would manufacturers and processors distinguish between the different morphologies

identified in the proposed regulatory text: what definitions would distinguish for example a rod

from an ellipsoid, needle, wire, and/or fiber as these shapes could be considered on a

continuum? Another commenter stated “It is unclear how different the shapes of two forms

would have to be in order to trigger the discrete forms requirement.”

Response: As noted in the proposed rule the different morphology could be any change in the

shape of particles. Different morphology does not include random shape changes or natural

variation in shapes of particles that are not definitive and that, as commenters have noted, occur

in a continuum. Some nanoscale materials are engineered to give all the particles a certain

morphology or shape. The change in shape needs to be a specifically engineered change in the

shape of particles of a nanoscale material, to effect a change and form a unique or novel property

for a chemical substance in the particle size range of 1-100 nm.

Comment 60: Several commenters stated that the definition of discrete forms of a reportable

chemical substance needed to be clarified, including factors to be used to distinguish discrete

forms. One commenter stated the factors should be eliminated from the rule as they are

unnecessarily burdensome, while other commenters suggested deleting some of the elements

such as zeta potential, dispersion stability, and surface reactivity. The commenters believe that

the proposed elements for reporting discrete forms “cannot reliably be measured” and that the

rule “compels companies to conduct tests on these or other physical-chemical properties to

determine whether they must report, many of which are not required or commonly performed.”

Response: To clarify the definition of discrete forms of a reportable chemical substance and

address these comments, EPA will include responses previously made to several other

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comments. EPA cannot require testing under a TSCA section 8(a) rule. While manufacturers

and processors are not required to test for the properties identified in the definition of discrete

forms of a reportable chemical substance, they are still required to determine their compliance

obligations under the rule based upon information that is in their possession or which is

reasonably ascertainable. If information within a company’s possession or that is reasonably

ascertainable does not demonstrate that the company is manufacturing or processing a discrete

form of a reportable chemical substance, there is no obligation to report. EPA expects that in

most cases such information will be in the company’s possession or reasonably ascertainable.

For example, persons subject to the rule may be required to report when they change a

manufacturing process to make a different size material in the range of 1-100 nm. However,

they are not required to report that different size material if particle size and surface area of the

nanoscale material have not sufficiently changed to meet the definition of a discrete form of a


Comment 61: Several commenters asked whether research and development is exempt from

reporting or asked EPA to clarify the exemption. One commenter asked EPA to define small

quantities. Others asked EPA if companies could sell research and development quantities for

profit or if reporting was required if the core commercial activity of a company was research

and development.

Response. As described in 40 CFR part 704.5(e), a person who manufactures (includes import),

processes, or proposes to manufacture or process a substance subject to reporting under this rule

only in small quantities solely for research and development is exempt from the reporting

requirements of the rule. Small quantities solely for research and development (or ‘‘small

quantities solely for purposes of scientific experimentation or analysis or chemical research on,

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or analysis of, such substance or another substance, including such research or analysis for the

development of a product’’) is defined in 40 CFR part 704.3 to mean quantities of a chemical

substance manufactured or processed or proposed to be manufactured or processed solely for

research and development that are not greater than reasonably necessary for such purposes. This

exemption applies if a company sells research and development quantities for a profit or if the

main commercial activity of the company is research and development.

Comment 62: A commenter asked what mechanism will be used to update any new information

if there is a change in manufacture, processing or use becomes necessary after the first

reporting of a discrete form.

Response: Because this rule only requires one time reporting, updating with new information is

not required unless a manufacturer or processor is reporting a new discrete form of a reportable

chemical substance.

Comment 63: Several commenters asked EPA to clarify reporting requirements for reportable

chemical substances that are contained in coatings and mixtures. One commenter asked EPA to

define coating. One commenter stated it is not clear why coated nanomaterials are defined

separately from chemical mixtures. The commenter stated there are cases where discrete

nanomaterials are surface treated (commonly coated with polymeric substances) in a similar

fashion as defined for chemical mixtures. Another commenter stated their seemed to be a

different standard for reporting on mixtures and that EPA needed to explain why this

information was necessary.

Response: Mixtures are not reportable under this rule; however the components of any mixture

that contains reportable chemical substances subject to the rule would be reported. The term

coating in the rule describes surface treating or coating of a reportable chemical substance with

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another chemical substance. The change in coating makes it a discrete form of a reportable

chemical substance subject to reporting even if all of the other intrinsic characteristics of the

reportable chemical substance remain the same. Coating or surface treating a nanoscale material

results in a nanoscale material with different properties. There is not a requirement that every

chemical substance coated or surface treated with another chemical substance must be reported.

However, any type of engineering including surface treatment of a chemical substance that

results in a reportable chemical substance requires reporting under this rule.

Comment 64: Commenters stated that EPA should clarify that the exemptions for new chemicals

reported since January 1, 2005 and the NMSP would not exempt information that has changed

since the original reporting.

Response: For a reportable chemical substance that was submitted as a new chemical substance

under section 5 of TSCA or as part of the NMSP, no updated information would need to be

reported unless a manufacturing or processing change resulted in a new discrete form of the


Comment 65: Several commenters asked EPA to clarify and confirm that articles are exempt.

Commenters asked if the article exemption would apply to textile yarns, fabrics, apparel,

nanometal metalized yarns, and extremely large and complex equipment. One commenter

supported the article exemption.

Response: As described in 40 CFR 704.5(a), a person who imports, processes, or proposes to

import or process a reportable chemical substance subject to this rule solely as part of an article

is exempt from the reporting requirements of this part with regard to that substance.

Manufacturers (including importers) or processors of a reportable chemical substance that is

incorporated into an article would be required to report any required information for activities

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before the chemical substance is incorporated into the article. An article is defined in 40 CFR

704.3 as manufactured item (1) which is formed to a specific shape or design during

manufacture, (2) which has end use function(s) dependent in whole or in part upon its shape or

design during end use, and (3) which has either no change of chemical composition during its

end use or only those changes of composition which have no commercial purpose separate from

that of the article, and that result from a chemical reaction that occurs upon end use of other

chemical substances, mixtures, or articles; except that fluids and particles are not considered

articles regardless of shape or design. The article exemption would usually apply to the products

cited by commenters. Any person who is not sure if their product meets the definition of an

article under TSCA should contact EPA for clarification.

Comment 66: Commenters stated that aggregates and agglomerates are not adequately defined.

One commenter asked if there was any threshold of energy for dispersion of aggregates and

agglomerates.

Response: There is no threshold of energy dispersion for aggregates and agglomerates.

Aggregates and agglomerate are defined using the definition from ISO to clarify the types of

particles that can be used to measure particle sizes, for purposes of determining if a chemical

substance is a reportable chemical substance subject to the rule. Primary particles are also

identified for this purpose.

Comment 67: Commenters asked for further clarification on emulsions and micro emulsions

and if they should be specifically included or excluded within the definition of a reportable

chemical substance.

Response: Emulsions and micro emulsions per se are not reportable chemical substances. If a

chemical substance contained in an emulsion meets the definition of a reportable chemical

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substance then that chemical substance is subject to the requirements of the rule. One example

cited by a commenter where a chemical substance had only incidental amounts of particles are

less than 100 nanometers and no size-dependent properties are being exploited would not be a


Comment 68: Commenters asked EPA to clarify that chemical substances used for

miniaturization through creation of nanostructures, and chemical substance used in nanoscale

manufacturing are not covered by this rule.

Response: If the chemical substances described by the commenter meet the definition of a

reportable chemical substance they would be subject to reporting requirements of the rule.

Whether a chemical substance is used in nanoscale manufacturing or miniaturization through

creation of nanostructures are not criteria of a reportable chemical substance.

Comment 69: A commenter asked that EPA allow reporting of multiple nanoscale forms of

reportable chemical substances in a single submission with appropriate identification of their

range in material properties. The commenter stated this would be more consistent with current

new chemicals reporting and should also assist with data management.

Response: Required reporting may be consolidated under the rule. Companies should consult

with EPA before submitting consolidated reports. EPA will issue guidance on consolidated

reporting on its website.

Comment 70: A commenter stated that crystallinity should be included in the reporting

requirements.

Response: Crystallinity is already included in the physical and chemical properties worksheet for

nanoscale materials specific data.

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Comment 71: Numerous commenters supported electronic reporting, although one commenter

supported only if it was fully functional. One commenter stated electronic reporting should be

voluntary. Other commenters noted the electronic reporting will not necessarily reduce the

reporting burden if it is not functional or for those persons who will be submitting a limited

number of reports.

Response. Even with the exceptions noted by commenters, overall electronic reporting remains

the least burdensome approach, based upon EPA’s extensive experience with electronic reporting

for PMNs and other submissions. EPA will assist persons subject to the rule with issues

regarding first time reporting or electronic reporting.

Comment 72: EPA specifically asked for comments on a future rulemaking for periodic

reporting on nanoscale materials in commerce. Numerous commenters did not support future

rulemaking for periodic reporting of nanoscale materials while another group of commenters

did support future periodic reporting requirements. Several commenters stated that it depended

on certain conditions such as limiting to manufacturers, no 135-day period, and the reporting

threshold.

Response: EPA will take these comments into consideration regarding any future rulemaking

proposal.

Comment 73: Commenters generally supported making data available to the public, including

reporting of aggregated information, integrating data with existing databases, including worker

exposure data, issuing for notice and comment each risk evaluation the agency conducts for

chemical substances reported under the rule, and making as much data public as possible

including limiting CBI claims. One commenter objected to using Chemview as it would just

generate a list of chemical substances/defacto Inventory with a negative connotation. The

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commenter asked if EPA would distinguish between different forms of the same chemical

substance.

Response: EPA will take these comments into consideration when making reported information

available to the public. EPA will make as much information publicly available as is feasible,

including different forms of the same chemical substance. How EPA presents that information

will depend on the information submitted and what is claimed as confidential.

Comment 74: A commenter stated that persons subject to the rule should be required to report

weight percentage of impurities and byproducts and should also be required to report the

chemical identity and particle size information.

Response: Chemical identity, particle size information, and weight percentage of impurities are

already part of the reporting requirements.

Comment 75: Several commenters did not support the exemption for reportable chemical

substances already reported under section 5 of TSCA. Commenters thought that additional

reporting of new information not previously reported would be an opportunity to update

production and use information.

Response: EPA continues to get updated data because of testing requirements and significant

new use notices for new chemical submissions that are nanoscale materials that have been

regulated under section 5 of TSCA. Under the 8(a) rule EPA will get reporting from

manufacturers or processors who did not report the nanoscale material under section 5 of TSCA.

EPA is including the exemption to avoid duplicate reporting.

Comment 76: Two commenters identified the three factors used to determine discrete forms of a

reportable chemical substance which are changes in process, size, and certain physical

properties for identifying a discrete form of a reportable chemical substance. The commenter

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proposed that a change in any one of those factors instead of all three factors should require

reporting of a discrete form of a chemical substance. One commenter stated this was because a

change in any one of these factors, “can independently affect the risk potential associated with

exposure to the substance and hence should trigger separate reporting.”

Response: Not all process changes result in significant changes in properties. Changing to just

one of those factors to require reporting would not allow for the natural variability of size and

properties of nanoscale materials. EPA will retain the approach of needing all three factors to

change.

Comment 77: One commenter stated that "release information" should specify that such

information should include any potential unintended releases into the environment such as

spills, fires, etc.

Response: Persons subject to the reporting requirements of the rule are already required to report

environmental releases from routine or repeated activity or even non-routine releases that are

known or reasonably ascertainable. However releases due to true emergency conditions such as

a fire or a catastrophic spill would not be reportable as that information is not reasonably

ascertainable and would be too speculative.

Comment 78: The definition of zeta potential appears incorrect in the proposed rule document,

and clarity is required to ensure the appropriate parameters are reported. The commenter

stated that “Zeta potential is not equivalent to the net surface charge on a particle, but rather an

estimation of that property. The zeta potential or electrokinetic potential of a particle is the

electrical potential of the particle’s interfacial double layer at the slip plane and is measured in

milliVolts.”

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Response: EPA agrees that the definition should be clarified. EPA will use a broader

description of zeta potential. Zeta potential is the electrostatic potential near the particle surface.

It can be measured using various methods. See ISO/TR 13014:2012 “Guidance on

Physicochemical Characterization for Manufactured Nano-objects Submitted for Toxicological

Testing” (Ref. 4) and the description of zeta potential by Colloidal Dynamics (Ref. 5) for

examples. It is typically measured by electrophoresis.

Comment 79: A commenter noted that the adverse effects cited refer to several articles wherein

the observed effects have been later attributed to residual solvent and inappropriate

experimental procedures.

Response: While some scientific information has changed for some of the articles referenced as

noted by the commenter, the scientific information in the other references in the proposed rule

and subsequent data that has been developed do demonstrate that some nanoscale materials may

have different properties regarding environmental health and safety.

Comment 80: One commenter stated the rule should include pesticides while other commenters

stated that the rule should not apply to any food, food additive, drug, cosmetic, medical device,

pesticide or other excluded material.”

Response: As stated in the preamble to the proposed rule, 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. This rule does not apply to those enumerated items

because there is no jurisdiction under TSCA to do so.

Comment 81: A commenter asked what the criteria are for distinguishing new processing

methods for a nanoscale material from existing methods. The commenter asked if EPA will

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provide guidance or regulatory citations as to what would constitute a process change that

would require filing a new report.

Response: The type of process change is not the criterion, it is the intent of the process change.

Any manufacturing or processing change that is intended to change particle size and properties

would be a process change that could require new reporting.

Comment 82: Two commenters stated that 22,000 pounds was still too large for a reporting

threshold and was not justified.

Response: The commenters are referring to the 22,000 pound production volume number cited

in the preamble of the proposed rule for premanufacture notices that were submitted for

nanoscale materials. EPA used that data to justify changing the small business exemption for this

rule. 22,000 pounds is not a reporting threshold in the final or proposed rule. There is no

quantitative reporting threshold.

Comment 83: Commenters stated that EPA should give more explanation on what it plans to do

with data.

Response: EPA intends to use the information to improve its assessment of nanoscale new

chemical substances. EPA will also review the information to determine if there are potential

risks that warrant risk management action. EPA will also make any non-confidential information

available to the public. Until EPA receives and reviews the data it is unable to give a more

detailed explanation of what it will do with the data.

Comment 84: A commenter stated the definition proposed for a discrete form needs to reflect

the preamble discussion that a change in both size and property is required, if this becomes part

of the final rule.

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Response: The definition in section 704.20(a) of the rule states that process, size, and property

must change to be considered a discrete form of a reportable chemical substance. EPA has

clarified the definition in a manner that reflect this.

Comment 85: A commenter noted that the preamble in the proposed rule stated that a change in

mean particle size of 10% or greater would be used to determine if a discrete form of a

reportable chemical substance differs from another form of the same reportable chemical

substance. However, the proposed regulatory text used 7 times the standard deviation of the

measured value (+/- 7 times the standard deviation) for the change in mean particle size. The

commenter asked EPA to clarify what was intended.

Response: In the proposed rule, the preamble inadvertently stated a change in mean particle size

of 10% or greater. The proposed regulatory text used the 7 times the standard deviation of the

measured values (+/- 7 times the standard deviation) for change in mean particle size. The 7

times the standard deviation language is what was intended and is contained in the final rule.

Comment 86: Commenters made numerous suggestions that fall outside the scope of the rule.

This included a future rule to define all nanosized chemical substances as new chemical

substances, reconsider promulgating the significant new use rule for nanomaterials, consider a

test rule and TSCA section 6 rule for nanomaterials, fully implement and fund TSCA, limit CBI

claims, explain how the requirements of the rule would inform safety-by-design principles, and

work with stakeholders to develop an international definition of nanomaterial.

Response: Because these comments fall outside the scope of the rule, EPA is not responding to

these comments. EPA may consider future measures based on submitted information

Comment 87: A commenter asked that EPA clarify that the film exemption includes polymer

coatings that are not in the 1-100 nm range.

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Response: If a polymer coating is not in the 1-100 nm range, it is not a reportable chemical

substance.

Comment 88: One commenter believes that the exemption for “ions” could be extended to any

material which fully dissociates or dissolves in water, regardless of size or degree of ionization,

as these materials will be equivalent to the molecular form in relevant environmental conditions

or during human exposures.

Response: EPA is not expanding the exemption as some nanoscale materials that do dissociate or

dissolve in water exhibit unique or novel properties.

Comment 89: One commenter stated “If the nanoscale material is fixed to non-nanoscale

materials and doesn't act as nanoscale material, it should be exempted from the scope of this

proposed rule because in such a case exposure will be very small.”

Response: If the nanoscale material is a reportable chemical substance then reporting would

still be required if it was “fixed” to a non-nanoscale material. EPA does not have enough

information on these types of materials to establish that exposures are small and exempt all of

them from reporting.

Comment 90: A commenter stated that “applications which result in low or no significant

pulmonary exposures to isolated nanoscale chemical substances should be exempt.”

Response: EPA does not have sufficient information to identify the applications or exposures

that would be the basis for an exemption. Therefore the Agency is not including such an

exemption.

Comment 91: EPA should clarify whether a final product made from a reportable chemical

substance that will be a solid article of non-nano scale such as a coated electrode or a

centimeter size crystal is subject to reporting.

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Response: If the final product meets the definition of an article at 40 CFR 704.5(a), it is exempt

from reporting. If a final product does not meet the definition of a reportable chemical

substance, it is not subject to reporting even if it was made using reportable chemical substances.

Comment 92: A commenter suggested that EPA exempt heavy fuel oils from reporting because

they are not manufactured to be 1-100 nm but some do fall within that size range.

Response: Heavy fuel oils would not require reporting as they are not solid chemical substances

and do not exhibit unique and novel properties because of their size. By definition a heavy fuel

oil is manufactured to be burned for energy. That intrinsic property will not change because of a

change in particle size.

Comment 93: A commenter noted there was no analysis of the impact of the 135-day notification

period, “Both in terms of sending a negative signal to the market and not allowing companies to

respond quickly to customer requests.” Commenters stated cost estimates should be adjusted to

consider potential profit losses due to the delay in market introduction.

Response: EPA’s responses to comments 42 and 43 have addressed that the 135 day period to

report a discrete form of a reportable chemical substance is only a notification program and does

not affect commercialization of existing chemical substances. Therefore, companies will not

experience delay in market introduction and potential profit losses as a result of this rule.

Comment 94: One commenter requested that the benefits to POTWs be included in the economic

analysis. They note that “Active EPA management of nanoscale materials will ensure that the

chance of costly incidents of wastewater treatment interference or restrictions on biosolids

disposal will be reduced.”

Response: The rule requires reporting on nanoscale materials only and does not assume that there

are risks related to these chemicals, nor does the proposed rule manage any potential risks

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associated with nanoscale materials. Therefore, it is not appropriate to include any benefits for

managing nanoscale materials in the benefits described in the Economic Analysis.

References from the Final Rule

1. EPA. Chemical Substances When Manufactured or Processed as Nanoscale

Materials; TSCA Reporting and Recordkeeping Requirements; Proposed Rule. Federal Register

April 6, 2015 (80 FR 18330) (FRL-9920-90).

2. 2016. EPA. Response to Comments to the Proposed Rule, Chemical Substances

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

Requirements; RIN 2070-AJ54. Docket # EPA-HQ-OPPT-2010-0572.

3. 2011. Executive Office of the President. Policy Principles for the U.S. Decision-

Making Concerning Regulation and Oversight of Applications of Nanotechnology and

Nanomaterials. https://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/

nanotechnology-regulation-and-oversight-principles.pdf

4. 2015. EPA. Economic Analysis for the TSCA Section 8(a) Reporting

Requirements for Certain Nanoscale Materials (RIN 2070-AJ54). xxxx xx, 2016.

5. 2012. International Organization for Standardization (ISO). Nanotechnologies—

Guidance on Physicochemical Characterization for Manufactured Nano-objects Submitted for

Toxicological Testing. ISO/TR (Technical Report) ISO/TR 13014:2012.

6. 1999. Colloidal Dynamics. The Zeta Potential.

http://www.colloidal-dynamics.com/docs/CDElTut1.pdf.

7. 2013. ISO/TR. Guidelines for Characterization of Dispersion Stability. ISO/TR

13097:2013.

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https://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf

https://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf


8. 2016. EPA. Information Submission Form. TSCA section 8(a) Information Reporting

for Nanoscale Materials. EPA Form No. 7710–[tbd]; EPA ICR No. 2517.02; OMB Control No.

2070–NEW.

9. 2013. EPA. Electronic Reporting Under the Toxic Substances Control Act; Final

Rule. Federal Register (78 FR 72818, December 4, 2013) (FRL 9394-6).

10. 2007. EPA. Nanoscale Materials Stewardship Program – Concept Paper.

11. OSHA. OSHA Hazard Communication Standard; 29 CFR part 1910.1200,

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099.

12. 2009. EPA. Interim Report on the Nanoscale Materials Stewardship Program.

13. 20##. EPA. Chemical-Specific Rules, Toxic Substances Control Act Section 8(a).

OMB control No. 2070-0067 (EPA ICR No. 1198.##).

14. 2015. EPA. Addendum to an Existing EPA ICR Entitled: Chemical-Specific Rules,

Toxic Substances Control Act Section 8(a). EPA ICR No. 2157.02; OMB Control No. 2070-

[new].

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