Concept Paper for the Nanoscale Materials Stewardship Program under TSCA


Purpose: EPA has developed this draft concept paper including Annexes
A-D to outline its initial thinking on the design and development of a
Stewardship Program for nanoscale materials under the Toxic Substances
Control Act (TSCA) (15 USC 2601).  EPA will publish a Federal Register
notice announcing the availability of this document and related
documents (TSCA Inventory Status of Nanoscale Substances – General
Approach, and a proposed Information Collection Request) for public
comment.  EPA also intends to conduct a public meeting to receive
further input and comment on all aspects of the Stewardship Program. 
EPA will also collaborate with other agencies in the development of the
program as appropriate.

1) Introduction and Summary

There is a growing class of materials commonly referred to as engineered
nanoscale materials.  Materials having structures with dimensions in the
nanoscale (approximately 1-100 nanometers (nm)), also known as nanoscale
materials or nanoscale substances, may have organizations and properties
different than the same chemical substances with structures at a larger
scale (See Annex A for a description of these terms).  

Nanoscale materials that meet the TSCA section 3(2)(A) definition of
“chemical substance” are subject to TSCA.  TSCA provides EPA with a
strong framework for ensuring that new and existing chemical substances
are manufactured and used in a manner that protects human health and the
environment.  For more details on EPA’s current oversight of nanoscale
materials please consult the TSCA Framework Document.  (Annex C)

EPA is developing a Nanoscale Materials Stewardship Program (“the
program”) to complement and support its new and existing chemical
efforts on nanoscale materials.  The program is intended to include but
not limited to engineered nanoscale materials manufactured or imported
for commercial purposes as defined in 40 CFR 720.3(r).  

The program is intended to:

Help the Agency assemble existing data and information from
manufacturers and processors of existing chemical nanoscale materials; 

Identify and encourage use of risk management practices in developing
and commercializing nanoscale materials; and 

Encourage the development of test data needed to provide a firmer
scientific foundation for future work and regulatory/policy decisions. 

Encourage responsible development. 

This paper outlines proposed ideas for reporting on existing nanoscale
materials in commerce, developing data on representative nanoscale
materials and identifying risk management practices.  The paper
describes who may wish to participate and the reporting expectations for
participants.  It also generally describes what EPA intends to do with
the data, what the program could entail, and why someone would choose to
participate.  It also describes the potential benefits of participation.
 These benefits include applying a stewardship approach to identify and
adopt environmental health and safety practices throughout an industrial
supply chain.  

The stewardship program would help address some of the issues identified
in EPA’s Nanotechnology White Paper.  The White Paper describes the
issues that EPA should consider to ensure that society benefits from
advances such as environmental protection that nanotechnology may offer,
and to understand the environmental health and safety implications of
nanoscale nanomaterials.

Participation in the program would not relieve or replace any
requirements under TSCA that a manufacturer, importer, or processor of
nanoscale materials may otherwise have.  

2) Who would participate? 

EPA envisions participation in the program by persons or entities that
do or intend to do any of the following, with the intent to offer a
commercially available product:

Manufacture or import engineered nanoscale materials

Physically or chemically modify an engineered nanoscale material

Physically or chemically modify a non-nanoscale material to create an
engineered nanoscale material

Use engineered nanoscale materials in the manufacture of a product  

The program is intended to encompass a broad range of participants who
manufacture, process, use, or import types of nanoscale materials for
commercial purposes as described above.  Both new and existing
substances (as determined by the status of the substance on the TSCA
inventory of chemical substances), regardless of whether they qualify
for exemptions or fall below a reporting or a notification threshold can
be included in the program.  Participation in the program would be
voluntary.  It will be left to the individual company to determine its
suitability for participation.  EPA is considering a program in two
parts.  One part, a “basic” program, would request participants to
report all known or reasonably ascertainable information regarding
specific nanoscale materials.  The other part, an “in-depth" portion,
would entail development of data as described in section 4.  EPA expects
that participants in the basic program could forward information as soon
as the program is developed.  Participants in the in-depth program would
develop a plan and submit data over a longer period.  

Annex A of this document gives further description and examples on who
may wish to report and what materials they would report.  The
description of who would report is not meant to be exclusive. 

3) Information to be Reported as Part of the Basic Program

The types of data that EPA has identified to be reported are detailed in
Annex B of this document.  These data include information on material
characterization, hazard, use, potential exposures, and risk management
practices.  EPA intends to conduct a scientific peer consultation on
material characterization to receive views and comments on the type of
material characterization information to be reported for nanoscale
materials.  EPA will announce that meeting in a separate Federal
Register notice.  Also attached is a draft form for submission of the
data.  Participants would be encouraged but not required to use this
form to submit information to the program.  This form and the types of
data to be reported are based on EPA’s Premanufacture Notice Form and
the information reported to EPA for new chemical substances under TSCA. 
EPA has also identified additional information that may be pertinent to
nanoscale materials.  More information is available about the data to be
reported in the proposed Information Collection Request for the program.

EPA will request that participants provide all the information described
in Annex B and the draft reporting form to the extent it is known or
reasonably ascertainable.  EPA is not requesting that participants
develop additional data.  If the information identified is not available
or applicable to the nanoscale substance, participants simply would not
submit those data.  However, it would be informative for respondents to
describe to EPA why the information is not available or applicable.  EPA
also encourages participants in the basic program to provide additional
data as it becomes available.  Each nanoscale material should be
reported separately.  If using the form, one form would be submitted for
each nanoscale material.  Participants who wish to identify nanoscale
materials collectively will be requested to describe the parameters that
form the basis for grouping.

As noted earlier, participation in the stewardship program would not
relieve or replace any requirements under TSCA that a manufacturer,
importer, or processor of nanoscale materials may otherwise have.  If a
manufacturer of a nanoscale material that is a new chemical substance
under TSCA submits a premanufacture notification to EPA, they may also
participate in the stewardship program by submitting the information to
the program.  Alternatively, the manufacturer may notify EPA of the PMN
submission of a nanoscale material it wants to include in the program.  

Confidential Business Information (CBI)

Recognizing this is a program which involves voluntary submissions of
information, EPA is advising potential participants in the stewardship
program that submission of information under the program will constitute
consent for the Agency to disclose this information as if it had been
submitted under TSCA.  Claims of confidentiality will therefore be
handled pursuant to 15 U.S.C. section 2613 and 40 CFR parts 2 and 720. 
EPA has a long history of successfully handling and protecting TSCA CBI
information.   

EPA encourages participants to give careful consideration to what they
will and will not claim CBI.  EPA encourages participants to make as
much data as possible available to the public.  EPA will protect
information claimed as CBI in accordance with procedures in 40 CFR parts
2 and 720.  Under some circumstances, EPA may, where possible, share
aggregated data with the public.  To achieve EPA’s mission of
protecting human health and the environment, EPA has long been committed
to integrating, in a meaningful way, the knowledge and opinions of
others into its decision-making processes.  As presented in EPA’s
Public Involvement Policy (Final May 2003), EPA believes that
“effective public involvement can both improve the content of the
Agency’s decisions and enhance the deliberative process.”  One
important aspect of EPA’s strong commitment to transparency is
involving stakeholders and the public in its decision-making processes. 

Risk Management Practices

Participants in the basic program would agree to implement a risk
management program that includes consideration of the nanoscale
material(s).   Participants would also agree to consider information
provided by EPA that is relevant to risk management for nanoscale
materials and to provide information about the risk management practices
and other aspects of their risk management program that are relevant to
nanoscale materials. On October 19-20, 2006, EPA conducted a scientific
peer consultation on Risk Management Practices to receive public input
in the development of these considerations.  EPA will include input from
this scientific peer consultation when developing risk management
considerations (Final Meeting Summary Report,   HYPERLINK
"http://www.epa.gov/opptintr/nano/nanopublicmeetingsummaryfinaloct2006.p
df" 
http://www.epa.gov/opptintr/nano/nanopublicmeetingsummaryfinaloct2006.pd
f ).  EPA encourages anyone with additional information on risk
management practices for nanoscale materials to submit the information
to EPA.  New information that EPA receives in the program or is
available from other sources may result in EPA amending the information
it considers relevant to risk management practices for nanoscale
materials.   EPA expects to further develop and communicate details on
risk management practices following public comment but prior to
initiation of the program. 

4) In-depth Data Development

The program outlined above is the structure of a basic reporting phase. 
It identifies data that participants would submit if they are in the
participant’s possession or reasonably ascertainable as defined in 40
CFR720.3(p).  The data and experience generated by the basic reporting
phase including input from the program evaluation of the basic reporting
phase will help to inform the types of in-depth data to be developed.  
In-depth data development could begin at any time and would entail a
certain subset of those data in a greater amount of detail.  In-depth
data development could also include additional data if they are
identified.

In-depth data development would likely apply to a smaller set of
representative nanoscale materials designated for further evaluation by
mutual agreement of EPA and participants, with input from stakeholders. 
For example, EPA and program participants could review existing data,
conduct preliminary assessments, and identify additional data needed to
better characterize hazard, risk, and exposure issues for the material. 
Once these needs are identified, a plan of action would be agreed upon
that could include:

Characterizing the physical/chemical properties of the material;

Testing for health and environmental hazards;

Monitoring or estimating exposures and releases;

Determining fate and transport characteristics;

Evaluating the effectiveness of protective equipment or engineering
controls;

Developing a model worker education program; and 

Other evaluations agreed to under the plan of action.

In some cases, a particular company may choose to do one or more aspects
of the plan, or a consortia of companies and other stakeholders may work
together to implement aspects of the plan.  The last three bullets above
are specific examples where input from OSHA and NIOSH would be valuable.
 At the completion of the plan, EPA and participants, with input from
stakeholders, would again meet to review the information gathered;
conduct final assessments; and consider any further action.  Any step
that would go beyond what is called for in the plan would be considered
on a case-by-case basis.

5) What Does EPA Plan To Do With the Data?

EPA will use the data to gain an understanding of which nanoscale
materials are produced, in what quantities, how they are used, and the
data that is available for such materials.  EPA scientists will use data
collected through this program, where appropriate, to aid in determining
how and whether certain nanoscale materials or categories of nanoscale
materials may present risks to human health and the environment.  

EPA may also use the information submitted to the program to make the
following determinations:

Identify the data that are missing to conduct an informed risk
assessment of a specific nanoscale material.  EPA may contact
participants on a case-by-case basis to clarify if further data are
available or why certain data were unavailable or not submitted.  

Identify nanoscale materials or categories of nanoscale materials that
may not warrant future concerns or actions, or should otherwise be
treated as a lower priority for further consideration. 

 

If the data is confidential business information, it may also be used by
other Federal agencies that have TSCA CBI clearance, in accordance with
CBI procedures.  Non-confidential portions of this information may be
used by the public, academics, states, local and tribal government, as
well as foreign governments and international organizations. 

If the hazard, exposure, and risk data submitted by a participant
indicate that potential risks may exist for a specific nanoscale
material, the data will be used by EPA and the participant to determine
the appropriate action necessary to avoid or mitigate the risks.  EPA
will address that situation on a case-by-case basis.

If the data submitted by a participant indicates that the participant is
manufacturing a nanoscale material that is reportable under section 5 of
TSCA (15 USC 2613) as a new chemical substance, EPA will immediately
inform the participant of that situation and the applicable TSCA
requirements (See Annex C for further discussion on TSCA Framework). 

EPA may publish a summarized interim report approximately one year after
initiation of the basic reporting phase of the program.  The report will
summarize to the extent possible considering CBI claims, the types of
data available, the reasons some data were reported as not being
available, additional data that would be needed for a better risk
assessment and any activities for which data are being used. 

EPA will also develop a more detailed report and evaluation of the
program two years after initiation of the program.  This report will
also address any program evaluation criteria EPA develops based on
public comment as well as how the stewardship program addressed the
objectives identified in section 6 below.  At that time EPA will
determine the future direction of the basic reporting phase as well as
in-depth data development..   

After public comment and further development of the stewardship program,
EPA will present a more detailed description of what it expects to do
with the data received in the NMSP. 

6) Why should I participate?

In the introduction to this paper EPA identified several objectives of
the program:

Help the Agency assemble existing data and information from
manufacturers and processors of existing chemical nanoscale materials; 

Identify and encourage use of risk management practices in developing
and commercializing nanoscale materials; and 

Encourage the development of test data needed to provide a firmer
scientific foundation for future work and regulatory/policy decisions:
and

Encourage responsible development. 1 

EPA believes that participation in the program will encourage
responsible development of nanoscale materials and will benefit all
stakeholders.  Development and sharing of data on nanoscale materials to
the fullest extent possible will enhance each stakeholder’s ability to
make informed decisions regarding nanoscale materials.  Applying a
stewardship approach will help participants to identify and adopt
environmental health and safety practices throughout an industrial
supply chain.  EPA is committed to an open and transparent process in
the development and implementation of the stewardship program. 

EPA is seeking comments and ideas on incentives for participation in the
program and how it can identify and reach out to the many small and
medium sized nanotechnology businesses.  Many of these entities have
limited experience with TSCA and limited resources to devote to
environmental programs, including the stewardship program.  EPA is
considering a series of workshops for such businesses, to inform them of
TSCA requirements as well as the stewardship program. 

ANNEX A

Description of Nanoscale Materials for Reporting

  SEQ CHAPTER \h \r 1 Scope

Included Substances

The Nanoscale Materials Stewardship Program (hereafter “the
Program”) is intended to encompass any substance in a form with one or
more dimensions in the nanoscale that has been manufactured or imported
for commercial purposes. Under TSCA, commercial purposes also include
research and development when there is a clear commercial intent.  The
program is open to both new and existing substances (as determined by
the status of the substance on the TSCA inventory of chemical
substances), regardless of whether they may qualify for any exemptions
or fall below a reporting or a notification threshold.

Participants

EPA envisions participation in the program by persons or entities that
do any of the following, with the intent to offer a commercially
available product:

Manufacture or import engineered nanoscale materials

Physically or chemically modify an engineered nanoscale material

Physically or chemically modify a non-nanoscale material to create an
engineered nanoscale material

Use engineered nanoscale materials in the manufacture of a product  

Breadth

The program is intended to encompass a broad range of types of nanoscale
materials and participants.  Participation is voluntary.  It will be
left to the individual company to determine its suitability for and
extent of participation.

Clarifications and Descriptions

“Engineered Nanoscale Material”

No official U.S. Government definition exists for the terms
“engineered nanoscale material” and “nanoscale.”  The
description given herein should not be considered to be definitive for
any purpose other than for EPA’s Nanoscale Materials Stewardship
Program; this definition is only applicable within the context of the
Program as a guideline for determining if a material is appropriate for
inclusion in the Program.

Briefly, an “engineered nanoscale material” is any particle,
substance, or material that has been engineered to have one or more
dimensions in the nanoscale.

“Engineered”

The term “engineered” is intended to mean that the material is 1)
purposefully produced and 2) purposefully designed to be a nanoscale
material.  The material may be produced from a “bottom-up” (i.e.,
through a process that causes atoms, ions, and/or molecules to bind
together to form larger materials; e.g., Chemical Vapor Deposition) or a
“top-down” (i.e., through a process that breaks down a macroscale
material; e.g., ball milling) technique.

“Nanoscale”

The term “nanoscale” is generally used to refer to the scale
measured in nanometers (1 x 10-9 meters).  For the purposes of the
Program, nanoscale is the size range between the atomic/molecular state
and the bulk/macro state.  This is generally, but not exclusively, below
100 nm and above 1 nm.  Materials engineered to be in this size range
can exhibit novel or enhanced properties.

Number of dimensions

For the purpose of the Program, any substance engineered with one or
more dimensions in the nanoscale may be appropriate for inclusion in the
program.

One-dimensional nanoscale materials 

The category of “one-dimensional nanoscale materials”—that is,
materials that have one dimension in the nanoscale and two dimensions
larger than the nanoscale—may be divided into two:

Particles

Films and coatings.

One-dimensional nanoscale materials that exist as particles (for
example, those having dimensions such as 50 nm x 1 µm x 1 µm) may be
appropriate for inclusion in the Program.  

It is generally assumed that films and coatings are not commercially
available as such (that is, as a solid, thin sheet), but rather are
available in a to-be-applied state (e.g., a mixture, solution or
suspension, such as paint, that is to be applied to a surface) or are
applied to another product, which is itself commercially available. 
To-be-applied films and coatings may also be divided into two
categories:

Those containing engineered nanoscale materials

Those that do not contain engineered nanoscale materials (e.g., a
chemical that will self-assemble into a one-dimensional nanoscale film
or coating upon application and treatment)

To-be-applied films and coatings in the first category (containing
engineered nanoscale materials) are intended to be included in the
Program.  To-be-applied films and coatings in the second category (not
containing engineered nanoscale materials) are not intended to be
included in the Program.

Products that have an already-applied nanoscale film or coating are not
intended to be included in the Program.

“Nanotechnology”

There are three terms regarding “nanotechnology / nanotechnologies”
that may be considered in the context of the Program: one developed by
the International Standards Organization (ISO), one developed by the
American Society for Testing and Materials (ASTM),  and the other by the
U. S. Government’s National Nanotechnology Initiative (NNI).  

The scope of the Program is tied to engineered nanoscale materials and
not to the definition of nanotechnology.  However, nanoscale materials
are expected to be created by nanotechnology, and, as such, it may be
instructive to consider these definitions in determining whether a
material is an engineered nanoscale material.

ISO identified the scope of its technical committee, TC 229, as:

Standardization in the field of nanotechnologies that includes either or
both of the following:

Understanding and control of matter and processes at the nanoscale,
typically, but not exclusively, below 100 nanometers in one or more
dimensions where the onset of size-dependent phenomena usually enables
novel applications.

Utilizing the properties of nanoscale materials that differ from the
properties of individual atoms, molecules, and bulk matter, to create
improved materials, devices, and systems that exploit these new
properties.

Specific tasks include developing standards for: terminology and
nomenclature; metrology and instrumentation, including specifications
for reference materials; test methodologies; modeling and simulation;
and science-based health, safety and environmental practices.

NNI description of “nanotechnology”

The NNI has described nanotechnology in the following way:

Nanotechnology is the understanding and control of matter at dimensions
of roughly 1 to 100 nanometers, where unique phenomena enable novel
applications. Encompassing nanoscale science, engineering and
technology, nanotechnology involves imaging, measuring, modeling, and
manipulating matter at this length scale.  (  HYPERLINK
"http://nnco5.nano.gov/html/facts/whatIsNano.html" 
http://nnco5.nano.gov/html/facts/whatIsNano.html )

2.2.3	ASTM definition of “nanotechnology”

ASTM defines nanotechnology as:  

	A term referring to a wide range of technologies that measure,
manipulate, or 	incorporate materials and/or features with at least one
dimension between 1 and 	100 nanometers.  Such applications exploit the
properties, distinct from 	bulk/macroscopic systems, of nanoscale
components.

Examples

The list of examples given herein should not be considered exhaustive,
but rather, should serve as guidance in determining whether a material
is appropriate for inclusion in the Program.

Examples of materials that would be appropriate for inclusion in the
Program:

Metal (e.g., Au, Ag, etc.) or metal oxide (e.g., TiO2, SiO2)
nanoparticles, quantum dots, nanotubes, nanowires, etc., including those
with core-shell structures (e.g., SiO2 coated with Au)

, where n ≥ 28)

Polymeric dendrimers (three dimensional polymers)

Materials derived from natural sources and further processed to produce
nanoscale-sized materials

Examples of materials that would not be appropriate for inclusion in the
Program:

Materials that have one or more dimensions smaller than the nanoscale
and/or are commonly considered organic molecules that only extend into
the nanoscale by virtue of having approximately 10 or more atoms
covalently bonded in a chain or a planar network.  Examples:

Polymers or oligomers, particularly linear or planar polymers, wherein
one or two dimensions may be in the nanoscale or larger.  Polymers are
explicitly excluded, when enough polymeric units or polymer molecules
are bound together to create macroscale materials.  E.g., polyethylene,
polystyrene, polyvinyl alcohol, polydimethylsiloxane.

Exceptions may be made when conditions of polymerization or
post-reaction processing have created free particles that otherwise fit
the general description “engineered nanoscale material.”

Exceptions will be made for polymeric dendrimers

Heavy Fuel Oils

Organic dyes 

Materials that only exist as a nanoscale material when in solution
should not be included.  Examples: 

Surfactant micelles

Salts

Soluble linear or planar polymers

Biological materials (e.g. DNA, RNA, proteins).  (The National
Institutes of Health (NIH) has issued a corollary that generally
excludes purely biological materials from the definition of
nanotechnology while acknowledging that many biological materials fall
within the range of the nanoscale.)

Materials that would be regulated solely by statutes other than TSCA
would not be included in the program.  If such materials are submitted
to the Program, the submitter will be advised to also contact the
appropriate office or other Federal agency.  Examples:

Materials that would fall under the authority of FDA (intended food
additives, pharmaceuticals, medical devices, cosmetics)

Materials that would fall under the authority of FIFRA (intended
pesticides)

Explosives

Certain radioactive materials

Examples of size-dependent, novel, or enhanced properties:

Surface area that is dramatically increased in comparison to the bulk
material

Reactivity that dramatically differs from the molecular or bulk material

Solubility or suspend-ability that differs dramatically in comparison to
molecular or bulk material

Absorption, transmission, emission, and/or fluorescence spectra that
differ substantially in wavelengths and/or intensity from the molecular
or bulk material

Paramagnetism

Ability to cross typical physiological barriers, such as skin,
blood-brain barrier, placenta, and cell membranes

Toxicity that differs from the bulk material

Characteristics (e.g., strength, absorption of light) of a macroscale
material (e.g., composite) that differ markedly when it is made from the
nanoscale material

ANNEX B 

DATA ELEMENTS

1. General Notes

Participation in the Program is voluntary.  EPA would request that all
relevant information that is known or reasonably ascertainable by the
participant be submitted.  EPA would also encourage participants in the
basic program to provide additional data as it becomes available.  EPA
will protect information claimed as CBI in the same manner as CBI
submitted under TSCA in accordance with procedures in 40 CFR parts 2 and
720 

A data submission form has been developed for the Program, which is
based on the standard PMN submission form.  Submitters are encouraged
but not required to use this form to submit information to the Program.

2. Types of Data 

The types of data being collected in the Program fall into these broad
categories:

General information about the submitter

General / identifying information about the substance

Production, importation, and use information

Exposure information

Risk management practices

Hazard information

Pollution Prevention information

Physical and chemical properties

2.1. General Information about the Submitter

Company name and contact information

Name and contact information of authorized official, agent, and
technical contact, as appropriate

2.2 General / identifying information about the substance

Chemical name

Common or trade name

Molecular formula and structure

Chemical identity (e.g. CAS number)

Reactants / monomers

Impurities and byproducts resulting from manufacture, process, use or
disposal

2.3 Production / importation information

Total amount of substance to be manufactured / imported

Amount of substance manufactured / imported for each use category 

Operational description

Current state of manufacture / importation and commercial availability

2.4 Exposure information and risk management practices 

(**includes input from the October 2006 EPA Risk Management Practices
for Nanoscale Materials Scientific Peer Consultation**) 

Overview of the lifecycle

All facilities and processes used in manufacturing and processing

All uses including expected consumer uses

Disposal of byproducts and end products

Number of people (e.g. workers, consumers) who may be exposed

Activities resulting in exposure

Duration of exposure

Environmental releases including amounts and medium of release

Environmental fate and transport

Exposure monitoring techniques and data

Control technology and rationale for their use at each release point

Data and measurement methods of waste treatment or purification
efficiency studies 

Additional procedures or equipment intended to mitigate exposures

Worker training

Hazard communication (e.g. MSDS)

Engineering controls and rationale for their use

Personal protective equipment (PPE) and rationale for their use

Cleaning, reuse, and disposal of equipment, including engineering
controls and PPE

2.5 Hazard information including any test data on: 

Health/environmental effects

Bioaccumulation / biomagnification

Biodegradation	

Fate and transport

2.6 Pollution prevention information

Information that may be used to assess overall net reductions in
toxicity or environmental releases and exposures

2.7 Physical and chemical properties

2.7.1 Properties found on standard PMN form

Physical state

Vapor pressure 

Density

Solubility in water or other solvents

Melting temperature

Boiling/sublimation temperature

Spectra

Dissociation constant

Octanol/water partition coefficient

Henry’s Law constant 

Volatilization from water and soil

pH 

Flammability / Explodability

Adsorption coefficient 	

2.7.2 Properties specific to nanoscale materials:  

(**will include input from future EPA Materials Characterization
scientific peer consultation **).

General description of unique or enhanced properties related to nanosize

Crystal structure

Agglomeration state/dispersion state   				

Particle size, shape, and mass

Surface area, charge, and chemical composition

Porosity

Diffusion

Gravitational settling

Sorption

Wet and dry transport

Influence of Redox and photochemical reaction

Mobility through soil

2.7.3 Obtaining the data

Methods and equipment used to obtain data

Cost of obtaining the data

Reasons for not collecting data

ANNEX C 

OPPT TSCA Framework

TSCA is a multi-media statute bridging the more narrow focus of media
specific statutes.  TSCA applies to “chemical substances.” 
Nanoscale materials which meet the TSCA definition of “chemical
substances” are subject to TSCA.  For the purposes of the Concept
Paper, “nanoscale materials” refers to chemical substances where one
or more dimensions are in the length scale of approximately 1 to 100
nanometers (i.e., nanosized).  They may also exhibit unique properties
that are different from those exhibited by the same substances as bulk
material and are usually the result of deliberate control of matter to
produce the substance at the nanoscale.  Several provisions of TSCA make
it an effective EPA tool for assessing and managing potential risks of
nanoscale materials.  

TSCA authorizes EPA to:

Receive notifications, assess, and manage risks of new chemicals, i.e.,
those chemicals not currently in commerce, which are not on the TSCA
Chemical Substances Inventory. (TSCA §5).

Manage existing chemicals which present “unreasonable risks,” which
is a standard under which EPA considers both costs and benefits of a
proposed action. (TSCA §6).

Define through rulemaking “significant new uses” of chemical
substances and require notification to the Agency prior to such
“significant new uses.”  EPA then has an opportunity to assess and
manage risks associated with those notified uses in a manner similar to
that used for new chemicals. (TSCA §5(a)(1)(B)).

Receive statutorily required notifications of “substantial risk”
information from chemical manufacturers, processors, and distributors.
(TSCA §8(e)).

Require manufacturers and processors of chemical substances to submit
lists or copies of reasonably ascertainable health and safety studies
(TSCA §8(d)).

Require manufacturers and processors to develop new test data on
chemicals. (TSCA §4).

Require manufacturers and processors to report information on chemical
use and exposures and other information. (TSCA §8(a)).

“Chemical substance” as defined under TSCA does not include certain
substances in specified circumstances such as drugs and pesticides as
defined under other authorities when manufactured, processed or
distributed in commerce for use as drugs or pesticides (TSCA §3(2)(b)).

New Chemicals

TSCA §5 facilitates EPA consideration of potential health and
environmental risks before a chemical substance is manufactured for
commercial purposes.  TSCA §5 requires persons to give EPA a 90-day
advance notice of their intent to manufacture or import a new substance
not listed on the TSCA Inventory.  TSCA §5 also authorizes EPA to
designate a specific use of a new chemical as a "significant new use"
through a significant new use rule (SNUR). In addition to requirements
and procedures for the submission of Premanufacture Notices (PMNs),
exemption notices can also be submitted under certain circumstances. 
These exemptions include among others:  (1) a low volume exemption
(LVE), (2) a low release and exposure exemption (LoREx), (3) a polymer
exemption, (4) exemption for R&D purposes, and (5) a test marketing
exemption (TME).

For any new chemical submission a review is conducted by EPA.  During
this review, additional information may be requested from the submitter
as appropriate (e.g., material characterization, engineering controls
and on-site treatment information) to help in assessing potential risk
from manufacture and use of the new chemical.  Because use of current
modeling tools may be limited for some nanoscale materials, qualitative
assessments would be prepared by EPA where appropriate.  The need and
options for possible control measures of the new nanoscale material are
presented at an OPPT Decision Meeting.  Decisions on each submission are
determined on a case-by-case basis, using the criteria in TSCA §5 and
in the relevant EPA regulations at 40 CFR parts 720, 721 and 723. 

Existing Chemicals

Chemical substances listed on the TSCA Inventory are considered to be
“existing chemicals” (including new chemicals that have been
reviewed by EPA, manufactured, and then added to the Inventory).  Under
TSCA section 6, EPA has the authority to prohibit or limit the
manufacture, import, processing, distribution in commerce, use, or
disposal of a chemical if there is a reasonable basis to conclude that
the chemical “presents or will present an unreasonable risk” of
injury to health or the environment.  “Unreasonable risk” is a
risk-benefit standard.  In order to regulate under section 6, EPA must
consider the effects of the substance on human health and the
environment, the benefits of the substance and the availability of
substitutes, and the reasonably ascertainable economic consequences of
the contemplated action.  Section 6(a) of TSCA requires that the
Administrator use the “least burdensome” regulatory measures that
protect adequately against risk.  

Reporting on Significant New Uses

EPA can also issue a SNUR for an existing chemical substance.  To
promulgate such a SNUR, EPA needs to find that a use or uses of an
existing chemical substance, in this case a nanoscale material,
constitutes a significant new use.  This involves considering a series
of statutory factors in the context of the chemical substance (e.g.,
projected volume of manufacturing and processing; extent to which a use
changes the type, form, or magnitude and duration of exposure; the
reasonably anticipated manner and methods of manufacturing, processing,
etc.).  In developing such a regulation, EPA also typically considers
potential hazards or risks and might identify testing that would help to
characterize the health or environmental effects of the chemical
substance.  The effect of such SNURs is to funnel subject chemical
substances into a notification and review process that, as a starting
point, is similar to that used for new chemicals but can be tailored to
meet the needs of the new use.  Regulatory actions (including testing
and control measures) similar to those for new chemicals can be taken if
the appropriate regulatory findings are made.  

Reporting on Production and Use Information and Health and Safety
Information

As an alternative or in addition to the use of SNURs, EPA can issue a
TSCA section 8(a) rule to obtain reporting of information on, among
other things, the manufacture or processing of an existing chemical. 
EPA could also consider issuing a TSCA section 8(d) rule to obtain
reporting on existing health and safety information on nanoscale
materials. 

Reporting of Information on Substantial Risks 

Section 8(e) of TSCA requires that chemical manufacturers, processors,
and distributors notify EPA of information that “reasonably supports
the conclusion that a chemical substance or chemical mixture presents a
substantial risk of injury to human health or the environment.” 
Section 8(e) reports most often contain toxicity data or
product/environmental contamination data but may also contain
information on exposure, environmental persistence or actions being
taken to reduce human health and environmental risks.  The information
submitted may be either full reports of studies known to the submitter
or summarized results on commercial or research & development chemicals.
 TSCA section 8(e) data are made publicly available (excluding any
Confidential Business Information).  

ANNEX D

Issues and Challenges  

Definitions of Nanotechnology and Nanoscale Materials.

The NNI describes nanotechnology as “The understanding and control of
matter at dimensions of roughly 1 to 100 nanometers, where unique
phenomena enable novel applications.”  Although the various agencies
and departments participating in the NNI have made use of this
definition, there are potentially a number of challenges to be worked
out in attempting to determine whether, and if so how, to apply it for
regulatory or other programmatic purposes, e.g., what the terms
“unique phenomena” and “novel applications” mean.  In addition,
other bodies such as the American Society for Testing and Materials
Nanotechnology Committee (ASTM E56), the American National Standards
Institute- Nanotechnology Standards Panel (ANSI-NSP), and the U.S.
Technical Advisory Group to the Technical Committee on Nanotechnology of
the International Standards Organization (US TAG to ISO TC 229) are
working on nanotechnology definitions.  In December 2006, ASTM issued
standard terminology relating to nanotechnology.  At some point it may
be appropriate for EPA to offer one or more definitions, possibly
accompanied by guidance, for programmatic and/or regulatory purposes.

Limitations of Current Knowledge Base.

The knowledge base of nanotechnology environmental health and safety
implications is limited.  A combination of approaches is being utilized
to help fill the gaps (identified through such sources as the EPA White
Paper and NNI research strategy).  These include research under the NNI,
testing by National Toxicology Program, National Institute of
Environmental Health Sciences, National Institute of Occupational Safety
and Health and others, Science To Achieve Results grants and budding
in-house programs in ORD, academic and corporate research.  This would
also include possible testing and/or other data submissions required by
OPPT under the new chemicals program or other means and testing by other
countries which is shared with the US (e.g. via the Organisation for
Economic Co-operation and Development (OECD)).  However, at present the
lack of a robust dataset leads to challenges in the risk assessment of
and decision-making on nanoscale materials. 

Inventory Status.

It will be important for the Agency to determine the extent of coverage
of nanoscale materials by the new chemicals provisions of TSCA.  The PMN
provisions of TSCA offer a solid foundation for review and
decision-making on nanoscale materials.  However, questions have been
raised regarding the extent to which nanoscale materials have molecular
identities that are the same as or different from those of chemicals
listed on the TSCA Inventory.  Such information would be valuable for
the Agency in determining the scope of any program that might be
desirable in addition to the review of nanoscale materials under Section
5 of TSCA.  It would also be helpful to industry to assist in
determining compliance.  The draft EPA document, TSCA Inventory Status
of Nanoscale Substances – General Approach, presents for comment
EPA’s current views regarding this issue.  

International.

A number of international activities are occurring in parallel to OPPT
activities, for example the development of voluntary programs in the
United Kingdom and Germany, work under the OECD Working Party on
Manufactured Nanomaterials to harmonize test guidelines and burden-share
the costs of testing nanoscale materials, and standards-setting work
under ISO.  It will be important for OPPT to stay abreast of, and where
appropriate provide leadership to certain aspects of this work.  Many of
the results, e.g., in the development of OECD test guidelines and ISO
standards, may have an impact on OPPT’s work on nanotechnology
including the stewardship program.   

E.  Data Scope Issues.

When receiving or requiring data, e.g., from manufacturers, there is a
wide variety of data that could be requested.  For example, the
International Life Sciences Institute report, (ILSI 2005) a report
developed by an expert working group sponsored by EPA to develop a
screening strategy for the hazard identification of engineered
nanomaterials, lists some 30 possible endpoints just for material
characterization.  It will be important for OPPT to define appropriate
data sets or tiers of data that would be useful to better understand
nanoscale materials, including material characterization, human health
hazard, environmental hazard, release and fate, and exposure.

F.  Testing and Test Guidelines.

It is not clear whether existing TSCA or OECD methods and test
guidelines need to be modified for use with nanoscale materials. 
Existing methods may in some cases need to be validated, and newer
methods, such as work in advancing in vitro methodologies, may be
desirable.  Specific materials characterizations issues for nanoscale
materials could come up in this context.  A certain amount of this work
will likely take place under the OECD Working Party on Manufactured
Nanomaterials, but certain aspects should also be addressed by EPA.  The
EPA Science Policy Council White Paper addresses a number of these
areas, including chemical identification and characterization,
environmental fate, environmental detection and analysis, potential
releases and human exposures, human 

 

health effects and ecological effects.  It will also be important to
look for opportunities to develop predictive models. 

G.  Risk Assessment Methodology.

At present, the state of the art of assessing the risk of nanomaterials
is still evolving.    

This capacity will need to rely on continuous improvement based on
practical experience reviewing nanoscale materials (e.g., as new
chemical submissions) and review and consideration of the efforts of
others (e.g., in the published literature, through the OECD, and to the
extent such reviews are undertaken by other programs or agencies). 
Where feasible, initiatives should be undertaken to help further build
this capacity.  For example, ORD and OPPT are jointly producing risk
assessment case studies on selected nanoscale materials.

	H.  Pollution Prevention Benefits

A number of nanoscale materials are likely to have environmental
benefits, including pollution prevention benefits.  It will be important
for OPPT to appropriately recognize the emerging pollution prevention
opportunities presented by nanotechnology.  In this regard a joint
OPPT/ORD conference on the pollution prevention benefits of
nanotechnology is being planned and will be announced in the Federal
Register.

I.  Materials Characterization  

As already described in paragraph E, further work remains to be done in
identifying the characteristics by which nanoscale materials or
subgroups of nanoscale materials will be described.  These
characteristics will be important for identifying various forms of
nanoscale materials and the appropriate methods to measure, evaluate,
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of the National Nanotechnology Initiative, The National Academies Press,
p. 73 (2006)

 PAGE   

 PAGE   21 

