# NANOSCALE MATERIALS

STEWARDSHIP PROGRAM

Interim Report

January 2009

U.S. Environmental Protection Agency

Office of Pollution Prevention and ToxicsNanoscale Materials Stewardship Pr ogram Interim Report January 2009



### Disclaimer

The purpose of this report is to summarize the information that has been submitted to the Agency under the Nanoscale Materials Stewardship Program. The findings and conclusions in this report should not be construed or interpreted to repres ent any Agency regulatory or statutory guidance or statement of official Agency policy. Every effort has been made to ensure that this document is consistent with existing polic ies and regulations; however, this report should not be used as a substitute for existing policy documents and re gulations. Further, al l classifications and comparisons in the report represent the best info rmation available to the Agency at the time of release and have not necessarily been reviewed or confirmed by the entities who have submitted information. Mention of trade names or commercial products does not constitute endorsement or

recommendation for use.

Comments on this report or the Nanoscale Mate rials Stewardship Program in general may be

submitted via http://www.epa.gov/oppt/nano/nano-contact.htm or emailed to: nano.stewardship@epa.gov . Confidential business information (CBI) should not be submitted electronically to EPA; instructions for submitti ng CBI are available on the contact web page.

Cover Photo: The balls in this picture are germanium and the wires are zinc oxide. They were fabricated inside a tube furnace system at temperature of 900-1000 Celsius degree. The source materials for this synthesis are zinc oxide powder, germanium powder and graphite powder. At the reaction temperature, zinc oxide and germanium oxide powders were reduced by graphite through a reduction reaction, providing zinc and germanium sources for zinc oxide nanowires and germanium balls growth, respectively. In this growth, the germanium balls act as the catalyst which direct the zinc oxide nanowires growth to finally sitting on the top of the nanowires. The diameter of the germanium balls is in the range of 1 to 5 micrometers and the diameter of the zinc oxide nanowires is in the range of 100 to 200

nanometers.

Concept for Image by UGA Fine Art Associate Professor Michael Oliveri FEI scans taken and assembled by Michael Oliveri Reprinted from http://michaeloliveri.com by Michael Oliveri with permission of Michael Oliveri

Nano structures created by UGA Physics and Engineering Assistant Professor Dr. Zhengwei Pan, along with his Post-Doctoral research associates Dr. Zhanjun Gu and Dr. Feng Liu. Credits: Michael Oliveri, Innerspace 4

2Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



## 1 Executive Summary

The Nanoscale Materials Stewardship Program (NMSP) was developed to help provide a
firmer scientific foundation for regulator y decisions by encouraging submission and
development of information for nanoscale materi als. The NMSP comprised two sub-programs,
the Basic Program and the In-Depth Program. When the NMSP was initiated, EPA committed to
issue this interim report after one year. The Agency welcomes comments on this interim report
EPA will issue a more detailed final report a nd program evaluation at the conclusion of the
NMSP in early 2010.

Under the Basic Program, EPA invited par ticipants to voluntarily report available
information by July 29, 2008 on the engineered na noscale materials they manufacture, import,
process or use. By that date, the Agency re ceived submissions from 16 companies and trade
associations covering 91 different nanoscale mate rials. As of December 8, 2008, twenty-nine
companies or associations submitted informati on to EPA covering 123 nanoscale materials and a
further seven companies have outstanding commitments to the Basic Program. EPA also invited
participants to submit new data that became ava ilable for nanoscale materials already reported or
to identify additional nanoscale materials to re port under the Basic Progr am. EPA is evaluating
the information submitted under the Basic Program through a process similar to that of a new

chemical review.

Under the In-Depth Program, EPA invited participants to work with the Agency and
others on a plan for the development of data on re presentative nanoscale ma terials over a longer
time frame. By the 6-month mark, one company had agreed to participate in the In-Depth
Program; by December 8, 2008, 4 companies have agreed to participate.

Based on the current interim results, the NMSP can be considered successful. However, a
number of the environmental health and safety data gaps the Agency hoped to fill through the
NMSP still exist. EPA is considering how to best use testing and information gathering

authorities under the Toxic Substances C ontrol Act to help address those gaps.

EPA will continue to review new chemi cal nanoscale materials submitted under the
Toxic Substances Control Act sections 5(a) and 5(h)(4) and apply, as appropriate, testing
requirements and exposure controls under sectio n 5(e) and Significant New Use Rules (SNURs)
under section 5(a)(2).

EPA continues to welcome new participants and information submissions for the NMSP,
which will continue until January 2010. The Agency will also continue to explore the best ways
to gather the information needed to provide a firmer scientific foundation for regulatory

decisions on nanoscale materials.

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## Table of Contents

1 Executive Summary ..................................................................................................................... 3

2 Introduction ................................................................................................................................... 5

3 Development of the Nanoscale Materials Stewardship Program (NMSP) ................ 6

3.1 Early Steps .............................................................................................................................................6

3.2 Development of the NMSP ...............................................................................................................7

4 Summary of Data Received under the Basic Program ..................................................... 9

5 Comparison of Data Received in the Basic Program with Available Information

on Commercial Nanoscale Materials ............................................................................................13

5.1 Limitations of the Comparison ................................................................................................... 13

5.2 Comparison Results ........................................................................................................................ 14

5.3 Summary and Next Steps of the Comparison ......................................................................... 18

6 Report on the In

­ Depth Program Participation ...............................................................19

7 r Rele Othe vant Activities in the US Government and Internationally .....................20

7.1 Da ta and Standards Development (Research and Testing) ............................................. 21

7.1.1 ORD’s Nanomaterial Research Strategy (NRS)

............................................................... ................21

7.1.2 NNI/NEHI

.............................................................................................................................. .........................21

7.1.3 OECD

.............................................................................................................................. ...................................22

7.1.4 International Organization for Standardization Technical Commit tee 229 (ISO/TC229)

22

7.2 Re gulatory and Policy Development ........................................................................................ 22

7.2.1 Regulatory Efforts on New Chemical Nanoscale Materials ........................................................22

7.2.2 Nanotechnology Policy Coordination Group (NPCG)

............................................................... ....23

7.2.3 Other

.............................................................................................................................. ...................................24

7.2.4 International Policy Coordination Efforts

............................................................... ..........................24

8 Conclusions

............................................................................................................................... ....26

9 Next Steps

............................................................................................................................... .......28

10 Annex A ­ Summary of EPA Nanomaterial Research Strategy ...............................29

11 Annex B ­ Description of OECD Working Party on Manufactured

Nanomaterials

............................................................................................................................... .......32

12 Annex C ­ Current NMSP Participants (as of December 8, 2008) .........................33

13 Annex D ­ OECD Sponsorship Program for the Testing of Manufactured

Nanomaterials (MN) ...........................................................................................................................36

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## 2 Introduction

There are unanswered questions about the po tential risks of nanoscale materials to human

health and the environment. Under the Toxic Substances Control Ac t (TSCA), EPA has the obligation to ensure that poten tial risks are adequately under stood and controlled to protect human health and the environment. The same sp ecial properties that ma ke nanoscale materials useful are also properties that may cause some nanoscale materials to pose potential risks to humans and the environment, under specific cond itions. At this point not enough information exists to fully assess these risks. This inform ation is important because EPA will need a sound scientific basis for assessing and managing a ny unforeseen future impacts resulting from the introduction of nanoscale materials into the environment. A challenge for environmental protection is to help fully r ealize the societal benefits of nanotechnology while identifying and minimizing any adverse impacts to humans or ec osystems from exposure to nanoscale materials

.

The growing diversity and complexity of the types and uses of nanoscale materials available and being developed pr esents challenges in evaluati ng risks associated with the

manufacture and use of these materials. A risk assessment combines an evaluation of exposure to a given substance with information on the toxici ty of the substance to assess or predict the probability, nature, and magnitude of the adverse effects that may occur. Understanding the following key aspects of risk assessment as they re late to nanoscale materials will be necessary for EPA to evaluate and manage any potential risks: chemical identification and physical properties characterization, environmental fate, e nvironmental detection a nd analysis, human and environmental exposure, human health effects, a nd ecological effects. In addition, EPA needs to understand how to best apply nanotechnology for pollution prevention in current manufacturing processes and in the manufacture of new nanoscal e materials, as well as in environmental detection, monitoring, and clean-up.

This understanding will come from scientif ic information generated by environmental research and development activities within gove rnment agencies, academia, and the private sector. Specific academic examples are the Centers for the Environmental Implications of Nanotechnology (CEIN) 

### and EPA's Science to Achieve Results (STAR) grants on nanotechnology. The National Nanot echnology Initiative will sponsor some of this research. Individual agencies such as the National Inst itute for Occupational Safe ty and Health (NIOSH) and EPA are currently conducting this type ofresearch. The Organization for Economic Cooperation and Development (OECD) will spur further research through its Sponsorship Program for Safety Testing a Representa tive Set of Manufactured Nanoma terials. Manufacturers and users of nanoscale materials will also develop this information. TSCA clearly states in section 2(b)(1) that it is the responsibi lity of manufacturers to develo p such information for chemical substances they manufacture.

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## 3 Development of the Nanoscale Materials Stewardship Program (NMSP)

EPA developed the Nanoscale Materials Stewardship Program (“NMSP” or “the program”) to complement and support its regul atory activities on nanosca le materials. The program was designed to help the Agency ga ther existing data and information from manufacturers, importers, processors, and us ers of nanoscale materials; to build EPA’s knowledge base in this area; and to identify and encourage use of risk management practices in developing and commercializing nanoscale materi als. EPA decided to initiate the NMSP to quickly learn about commercially available nanoscale materials, while identifying and encouraging risk management practices. Data developed for and obtained from the NSMP will help EPA to address some of the recommendations identified in the February 2007 EPA Nanotechnology White Paper ( http://www.epa.gov/osa/pdfs/ nanotech/epa-nanotechnologywhitepaper-0207.pdf ). The data will also help to dete rmine next steps in development of environmental health and safety data and appr opriate regulatory actions under TSCA. EPA believes that participation in the NMSP will encourage responsible development of nanoscale

materials and will benefit all stakeholders. EP A views the data development efforts under the NMSP to be an important integral compone nt of EPA’s commitment to national and international efforts to understand exposures, hazards, and risks of nanoscale materials.



### 3.1 Early Steps

The Agency held an initial public meeting in June 2005 on the TSCA and Nanotechnology (70 FR 24574) to discuss a poten tial voluntary pilot pr ogram for certain

nanoscale materials and the information needed to adequately inform the conduct of the pilot program. During the period July through November 2005, EPA worked with a federal advisory committee, the National Pollution Prevention an d Toxics Advisory Committee (NPPTAC), todevelop further understanding on TSCA and nanotechnology issues. A NPPTAC Interim Adhoc Workgroup on Nanoscale Materials was formed and developed an Overview Document that discussed several aspects of TS CA and nanoscale materials, incl uding possible elements of an EPA voluntary program for existi ng chemical nanoscale materials ( http://www.epa.gov/oppt/npptac/pu bs/nanowgoverviewdocument20051125.pdf ). The document was submitted by the NPPTAC to EPA for its consideration in November 2005.

The Overview Document stated that the de gree to which a voluntary program is meeting

or has achieved its overall goal and other objectives w ould depend on the following:

• The rate of participation;

• The amount and quality of information generated by the program participants;

• The adequacy and potential effectiveness of existing risk management practices; and

• The lessons and conclusions that can be drawn from the program experience, for example:

o Characteristics of nanoscale substances that should be considered in risk assessment and risk management;

6Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

o Which, if any, regulatory changes are needed to address nanoscale materials; and

o Risk management practices appr opriate to nanoscale substances.

The Overview Document stated that a volunt ary stewardship program was an important early step in assisting EPA to assess and addr ess potential risks of engineered nanoscale materials and that a high level of participa tion and cooperation will provide the public with greater assurance that engineer ed nanoscale materials will be managed in a responsible and accountable manner. A key outcome of the propos ed voluntary program would be to “provide the information and experience necessary to deve lop an overall approach to the treatment of

nanoscale chemical substances under TSCA...”



### 3.2 Development of the NMSP

EPA subsequently undertook to develop a vol untary stewardship program for nanoscale materials generally following the approach suggested by the NPPTAC document. EPA conducted a scientific public pe er consultation on risk management practices for nanoscale materials in October 2006, ( http://www.epa.gov/opptintr/nano/ nanopublicmeetingsummaryfinaloct2006.pdf ). In a discussion paper prepared for the meeting, EPA presented the results of a literature search and asked for input on risk management practices. EPA identified the NIOSH document “Approaches to Safe Nanotechnology: an Information Exchange with NIOSH ” as a primary resource. Attendees and panelists offered additional comments and resources on risk management practic es. One point of general agreement was that EPA should continue to work closely with NI OSH regarding risk management practices for

nanoscale materials. EPA continues to consul t with NIOSH, especially regarding risk management practices for new ch emical nanoscale materials.

In July 2007 ( http://www.epa.gov/fedrgstr/E PA-TOX/2007/July/Day-12/t13558.htm ), the Agency announced the availability of three draft documents pertaining to the NMSP:

o A Concept Paper for the Nanoscale Materials Stewardship Program;

o TSCA Inventory Status of Nanoscale Materials - General Approach; and

o An Information Collection Request for the NMSP that included a proposed optional reporting form.

EPA held a public meeting in August 2007 to soli cit input on the draft documents and the design of the NMSP ( http://epa.gov/oppt/nano/mtgsummary080207.pdf ).

In September 2007, the Agency held a sec ond scientific public p eer consultation. This

second consultation focused on material characterization of nanoscale materials ( http://www.epa.gov/oppt/nano/mc09072007-mtgsummary.pdf ). EPA prepared a document for the meeting which provided background informa tion and contained a series of questions on discussion topics for the materi al characterization of nanoscale materials. Discussions surrounding those questions informed EPA of data elements that are important for material characterization. Several panel members spec ifically mentioned surface modification as a potentially important data element. Multiple panelists discussed their view that virtually all

7Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

properties have some importance. Some panelists commented that because there is a lack of information regarding potential effects associated with exposur e to nanoscale materials, EPA should attempt to acquire as much information as possible rather than limiting the effort to investigate certain properties. Ot her panelists acknowledged that a ll properties could potentially result in an impact; however, they felt it would be more appropriate to prioritize efforts and focus on properties that are most likel y to result in an impact. They acknowledged that the costs associated with testing may have an impact on which tests should be performed, if only limited useful information would be produced.

EPA finalized its approach under the NMSP based on written public comments, comments received at the public meeting, and the two scientific peer consultations. Subsequently, on January 28, 2008, the Agency announced the final design and format of the NMSP in the Federal Register ( http://www.epa.gov/fedrgstr/EPA-TOX/2008/January/Day28/t1411.htm ) and invited interested parties to participate in the program.

The NMSP has two components, a Basic Pr ogram and an In-Depth Program:

• Under the Basic Program, EPA asked manufacturers, processors, importers, and users of

chemical nanoscale materials to submit existi ng information on their nanoscale materials, i.e., physical and chemical properties, h azard, exposure, use, and risk management practices or plans, during the first six months of the program. The Agency also invited researchers who develop or study engineer ed nanoscale materials to participate.

• Under the In-Depth Program, EP A invited participants to sponsor the development of test data for representative nanoscale materials and to work with the Agency to devise a data development plan. A particular sponsor may ch oose to implement one or more aspects of the plan; or a consortium of sponsors and other stakeholders may work together to implement aspects of the plan. At its co mpletion, EPA and sponsors will review the information gathered; consider input from stakeholders; conduct final assessments; and consider further action. Efforts under the In-Depth Program are relevant to the work being done under the OECD Working Party on Manufactured Nanomaterials (WPMN) (see Section 7.1.3 for further desc ription of the WPMN).

EPA conducted an extensive outreach campai gn to educate and encourage participation

in the NMSP. In addition to the Federal Re gister notices, public meeting, and two peer consultations discussed above, the Agency reac hed out to over 150 individual companies and 11 trade associations through letter s, phone calls, and meetings. EPA senior managers and staff presented on the NMSP at over 30 international, national, and regional meetings. EPA also

discussed the NMSP with other fede ral agencies to get their input and to encourage federal and non-federal researchers to pa rticipate in the program.

8Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



## 4 Summary of Data Received under the Basic Program

Under the Basic Program, EPA invited par ticipants to voluntarily report available information by July 28, 2008 on the engineered na noscale materials they manufacture, import, process or use. By that date, the Agency received submissions from 16 companies and trade associations covering 91 diffe rent nanoscale materials base d on 47 different chemicals 1 . The comparative work in this report is based only on submissions received by September 1, 2008 2
and includes submissions from 21 companies and trade associations and on 106 nanoscale

materials based on 52 different chemicals. A listing of participati ng companies and trade associations and the nanoscale materials they have reported is attached as Annex C. A more upto-date listing is also available on EPA’s NMSP website ( http://www.epa.gov/oppt/nano/ stewardship.htm ) which is updated whenever EPA receives additional information. EPA has posted copies of all non-confidential submissi ons and, when supplied by NMSP participants,

sanitized versions of confidential submissions on the website. The information and results presented in this section ar e preliminary and may change as the Agency receives more

information and finalizes its assessment of the NMSP submissions.

Thus far, the program has considerably increased the Agency’s understanding of the types of nanoscale materials in commerce. Most submissions included information on physical and chemical properties, commercial use (real ized or projected), basic manufacturing and processes as well as risk management practices. However, very few subm issions provided either toxicity or fate studies. Because many submitters claimed some information as confidential business information, the Agency is limited in the details of what it can re port for any particular

submission.

In reviewing the submissions, the Agency recognized that many materials are currently produced only for research and development (R&D ) purposes. This information is important to the Agency for several reasons, including:

• Providing a baseline assessment of the re lative commercializa tion of different nanoscale materials;

• Allowing the Agency to identify nanoscale materials near commercialization and prioritizing future research and regulatory efforts; and

• Informing Agency staff on various na noscale material issues including environmental fate, toxicity, and physica l-chemical properties in comparison to the bulk scale. The Agency anticipates dr awing upon this in-house experience in future nanoscale material regulatory and research work, including the New Chemicals Program.

1 As of December 8, 2008, twenty-nine compan ies and trade associations have submitted information to EPA covering 123 nanoscale material s based on 58 different chemicals. Another seven companies have committed to submit information.

2 Technical challenges with re peating the comparison as new submissions continue to be received prevents on-they-fly updates.

9Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

Figure 1 illustrates the numb er of nanoscale materials and chemicals used for R&D purposes as well as commercial activities submitted to the NMSP. It is important to note that

EPA maintains a distinction between “chemical substances” and “na noscale materials” throughout this report. “Chemi cal substances”, as defined under TSCA, are distinguished by unique molecular identities, and, in this report, are referred to as chemi cals. This issue is discussed in more detail in the EPA pape r on the TSCA Inventory Status of Nanoscale Substances – General Approach ( http://www.epa.gov/oppt/nano/nmsp-inventorypaper2008.pdf ).

From submissions to the NMSP as well as othe r information sources used in the comparison

discussed in Section 5 , it is not always possible to determine the exact molecular identities of the nanoscale materials provided. Information in some submissions was such that only a portion of the molecular identity was reported, e.g. this might be the case for a substance that was coated

with another unidentified substance or for a s ubstance for which the crystal structure was not provided. For the purposes of this report, these materials with incomplete or unidentifiable molecular identities are grouped based on the available information regarding the primary composition of the core substance (as opposed to a surface coating). As part of the follow-up work, EPA will work to clarify the mol ecular identities of the submissions.

For this NMSP interim report, the Agency considered each substance submitted to the Basic Program to be a unique “nanoscale material ”. Nanoscale material s include research, precommercial, and commercial nanoscale substances and may be different chemicals (e.g. anatase

titanium dioxide and rutile titani um dioxide) or that are differe nt physical forms of the same chemical (e.g. 10 nm rutile titanium dioxide and 20 nm rutile titanium dioxide). Some submitters reported “nanostructured” materials, i.e. a materi al whose overall material size was greater than 100 nanometers (nm) but which contained active stru ctures within the materials of less than 100 nm. The Agency would find it helpful to continue to receive more information on each of the commercial nanoscale materials being produced. 

## 0 20 40 60 80 100 120

Chemicals NMsNumber 

### Commercial

R&D

Figure 1 Many nanoscale materials (NMs) in the NMSP are for R&D purposes only. However, when those submissions are grouped into chemical substances, Agency received at leas t one commercial nanoscale material submission for the majority of cases.

10Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

Although not being able to identify the specific molecula r identity of all nanoscale materials provided, the Agency has identified 18 nanoscale materials in the NMSP submissions as potentially being “new” chemi cals under TSCA; these, include na noscale materials that are at the research and development stages. As the molecular identities of many submissions are incomplete, any designations of a chemical or na noscale material as “new” or “existing” in this report is based solely on the best available info rmation and is not a dete rmination for regulatory

purposes.

For initial comparative purposes, Fi gures 2 and 3 group the NMSP nanoscale materials by general chemical category and ge neral physical shape, respectively, noting the breakdown of commercial versus R&D as in Figure 1.



## 0 10 20 30 40 50OtherNanoclaysOrganicmoleculesOrganicpolymerAmorphoussilicaCarbonMetaloxidesMetalsNumber of NMs 

### Commercial

R&D

Figure 2 Submissions of the nanoscale materials (NMs) in the NMSP grouped by chemical category.

Figure 4 illustrates data elements reported as a percentage of NMSP submissions; most of the reported data elements in the NMSP were for use, material characterization, and risk management practices. Relatively little environmental health and safety data was reported. For this interim report, EPA did not analyze the utilit y or completeness of the data elements of the submissions; this analysis will be provid ed in the final report of the NMSP.

11Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

12 Figure 3 Submissions of the nanoscale materials (NMs) in the NMSP grouped by physical shape

Figure 4 Submissions of nanoscale material (NMs) to the NMSP by inclusion of data for a particular elementPercent of NMsNanoscale Materials Stewardship Pr ogram Interim Report January 2009



## 5 Comparison of Data Received in the Basic Program with Available

Information on Commercial Nanoscale Materials

As far as EPA is aware, there is no comprehe nsive database of nanoscale materials, which is a critical need for better understanding th e universe of commercia lly available nanoscale materials. Consequently, over the past seve ral months, EPA developed a baseline of the nanoscale materials that are apparently commer cially-relevant in the United States. In developing this baseline, EPA evalua ted two well-recognized data sources 3 for nanoscale materials, the Nanowerk Nanomaterials Databa se and the Wilson Center Project on Emerging Nanotechnologies (PEN) Inventory of Nanomateri als in Consumer Products, and compared the

information in these data sources with information received in the NMSP submissions. The Agency welcomes further views on expanding and refining this comparison. The information and results presented in this section are prelim inary and may change as the Agency receives

more information and finalizes its assessmen t of the NMSP submissions and the underlying

datasets.



### 5.1 Limitations of the Comparison

In utilizing this data, the Agency acknow ledges there are limitations with both the

Nanowerk and Wilson Center databa ses; neither were designed to answer questions regarding any specific company’s production or use of a particular nanoscale material. These databases

had other limitations that are described below.

Nanowerk LLC collects, catalogs, and publishe s information on nanoscale materials that

are available for commercial and research sale. The Nanowerk database does not, for example: distinguish between resear ch and commercial use; regularly update the ava ilability of the listed nanoscale materials from the companies listed; or verify the characterization data provided by the companies. Furthermore, not every material th at the Agency has identified from its review of the literature as being produced in the nanoscale form is included in the Nanowerk database (e.g., non-carbon nanotubes and caged structures anal ogous to carbon fullerenes, nanoclays, and dendrimers).

The Wilson Center PEN collects, catalogs , and publishes information on commercial products for which the manufacturer makes a reasona ble claim or appears to make a claim that the product contains nanoscale materials. The PE N database does not verify whether a particular product actually does contain na noscale materials nor does it always provide the specific molecular identity and form of a particular na noscale material for ve rification. Commercial

3 Further data sources under consideration by EPA for its ongoing analyses include: Environmental Working Group Survey of Nano-S cale Ingredients in Cosmetics, the National Nanotechnology Initiative and EPA reports on nanoscal e materials, results of similar initiatives in other countries reported through the OECD WPMN, and from se arching scientif ic literature and company promotional websites.

13Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

products that are not advertised by manufacturer s to contain nanoscale materials are not likely

included in the database.

It is important to note that many of the pr oducts and materials included in the PEN and Nanowerk databases may be excluded from or exempted under TSCA regulation (cosmetics, pesticides, R&D chemicals, etc.). Additionally, some substances or products may be manufactured outside the U.S., but for this report, EPA assumes that they may be available for importation. These databases also do not includ e every supplier or every commercial form of a

nanoscale material that ma y be available for sale.



### 5.2 Comparison Results

At the Agency’s request, the Nanowerk da ta were graciously pr ovided by Nanowerk LLC as of July 15, 2008, with some data removed to pr otect intellectual property. The Agency did not remove non-US companies from the comparison b ecause the substances may be available for import into the US. As part of the comparis on, the Agency merged equivalent fields from disparate tables to create a single table describing 2,084 potential nanoscale materials. Excluding

materials not of interest to EPA for the NMSP and materials that would be considered “new” chemicals under TSCA (such as carbon nanotubes and fullerenes) 4 , and by grouping together

entries that had the same molecular iden tity, EPA identified 1332 nanoscale material submissions based on 199 unique existing chemicals. For the purposes of this report and as a starting point for discussion, EPA considered evidence of 5 commercial product forms (as

described as in Section 4 of this report) of a chemical substance in the Nanowerk database to

indicate commercial relevance. 5 Using this threshold, EPA id entified 55 commercially-relevant

chemicals in the Nanowerk database.

EPA utilized the PEN data from the February 22, 2008 update of the database for this comparison. As with the Nanowerk database, the Agency merged equivalent fields from this

table with a master table of na noscale materials from the other s ources. Of the 606 products in the database, EPA was able to identify or make a reasonable estimate of at least the partial molecular identity in 467 produc ts (77%) for a total of 566 nanoscale materials (some products appeared to contain mult iple nanoscale materials) 6 . The Agency considered the likely presence

4 For the purposes of this report, “new” chemicals include those that would have been reported to the Agency as a new chemical in commerce since January 1 st , 2005, as well as chemicals that have not yet been reported. “Materials not of interest” to the NMSP are based on the 2008 NMSP Concept paper, Annex A, Section 3.2 available at: http://www.epa.gov/oppt/nano/nmspconceptpaper.pdf , but these exclusions are applied only to the PEN and Nanowerk datasets for comparison purposes.

5 The Agency selected the threshold of 5 co mmercial product forms for this interim report largely because, in reviewing individual nanos cale materials it became clear that a high proportion were likely to be “made to order” and/or available onl y for R&D, particularly when only one or a few forms were liste d. EPA would like to better refi ne this baseline approach for the final report, and would welcome co mments on the selected methodology.

6 EPA was not able to identify any nanoscale material in 66 of the products and made a reasonable estimate for the identity of a nanos cale material in 63 products, based on available

14Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

of a nanoscale material in a single commercial pr oduct to be sufficient for meeting the threshold of commercial-relevance. Using this thre shold, EPA identified 48 commercially-relevant

chemicals in the PEN database.

0 200 400 600 800 1000 1200 1400 1600 1800 2000

All Commercial Existing Commercial,
Existing Nanowerk

PEN

NMSP

Figure 5 Comparison of Nanowerk, PEN, and NMSP nanos cale materials. Only nanoscale materials with a molecular identity of interest to EPA under the NMSP are counted, and ‘existing’ refers to nanoscale materials that have a molecular identity corresponding to an existing chemical on the TSCA Inventory.Number of NMs

compares the number of distinct nanosca le materials in the three datasets using

the three different data sources. compares the number of distinct chemicals in the three datasets. Both figures consider the likely commer cial status and whether the nanoscale material is on the TSCA Inventory (i.e., “existing”). Comp aring either the Nanowerk or PEN datasets to

the submissions received under the NMSP demons trates the potential for significant gaps between existing chemicals that may already be commercialized and those submitted under the

NMSP. Figure 5
Figure 6

and Figure 8 examine the overlap be tween the different datasets of existing chemicals and existing commercially-relevant ones, respectively. EPA found a total of 234 unique existing chemicals with Nanowerk havi ng 199, PEN with 48, and the NMSP with 34. The diagrams indicate that each dataset contai ns a significant number of chemicals at the Figure 7

information. The Agency suspected that 78 of the products might contain a nanoscale material,

but was not able to ascertain the molecular identity. EPA identified 48 existing chemicals of interest and four categories of nanoscale materials (such as nanoc lays or polymers) for which a specific molecular identity could not be ascertai ned. For the cases where only chemical category could be determined, we counted each instance as a unique chemical. Fluorinated polymers in the PEN database are counted as a single chemical although they may ultimately have different chemical identities as they originate from a single company and brand.

15Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

nanoscale exclusive to that dataset: 85% in Na nowerk, 46% in PEN, and 26% in the NMSP. EPA found a total of 91 unique commercially-relev ant existing chemicals with Nanowerk having 54, PEN with 48, and the NMSP with 15. The diagra ms indicate that each dataset contains a significant number of chemicals at the nanoscale exclusive to that dataset: 63% in Nanowerk, 58% in PEN, and 29% in the NMSP. A signifi cant challenge and follow-up activity is to determine the uniqueness of substances for whic h only limited molecular identity information is available. For example, each incomplete polymeric substance is counted as unique because of the tremendous variety of polymers available today. While each dataset ha s a significant proportion of chemicals unique to that datase t, the overlap of the datasets is remarkably consistent with the OECD testing efforts (described in Section 7.1.3 ) on a representative group of 14 commercial

nanoscale materials. Seven of the twelve substan ces common to all three datasets of existing chemicals (Figure 8) are targeted for testing. On ly four substances are missing from all three datasets: nanoclays, dendrimers, polystyrene , and iron. Twelve of the fourteen OECD representative substances are covered by the NMSP; only iron and dendrimers are missing.



## 0 200 400 600 800

All Commercial Existing Existing,

Commercial 

### Nanowerk

PEN

NMSP

Figure 6 Comparison of Nanowerk, PEN, and NMSP chemicals. Only NMs with a molecular identity of interest to EPA under the NMSP are counted, and ‘existing’ refers to NMs that have a molecular identity corresponding to an existing chemical on the TSCA Inventory.

Note: For counting purposes in this report, each carbon nanotu be in the datasets is counted as a unique chemical (over 400 in Nanowerk) because the Agency has not yet set a policy for distinguishing or grouping carbon nanotubes for TSCA Inventory purposes. Hence, chemical counts are significantly increa sed. They are treated as ‘new’ chemicals, however, and therefore are not included in the existing chemicals analysis.Number of Chemicals

16Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

Figure 7 Overlap of existing chemicals between the Nanowe rk, PEN, and NMSP datase ts. EPA found a total of 234 unique existing chemicals. The counts refer to the chemicals in each category of overlap. In addition to the 34 existing chemicals, the NMSP contained 18 new or likely to be considered new chemicals.

Figure 8 Overlap of existing commercially-relevant chemicals between the Nanowerk, PEN, and NMSP datasets. EPA found a total of 91 unique chemicals. The counts refer to the chemicals in each category of overlap. Beyond the 15 chemicals

17Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



### 5.3 Summary and Next Steps of the Comparison

Combining all three datasets, EPA identified over 200 existing chemic als that are produced at the nanoscale for commercial and R&D purposes, of which 91 are likely to be manufactured for commercial purposes. Of these, 28 chem icals are included in the NMSP submissions under the Basic Program. However, only 15 of these 28 commercially-relevant, existing chemicals in the NMSP had submissions indicating commercial pr oduction – the rest we re R&D submissions.

The NMSP also included four subm issions on existing commercial chem icals that were not in the Nanowerk or PEN datasets. While the comparison is not complete, it illustrates a potential gap between the approximately 91 different chemical s from which commercially-relevant nanoscale materials may be produced and the submissions under the NMSP. However, through the NMSP and the TSCA New Chemicals programs, as well as as other programs described in Section 7 (in particular, the OECD testing pr iorities discussed in Section 7.1.3 ), the Agency has identified additional commercially available nanoscale materi als that would not meet the likely commercial production thresholds from the Nanowerk and PEN data sets alone. The Agency will continue to

consider other sources of data and tools for identifying commercial production of nanoscale

materials.

This interim comparison provides a framework that supports the Agency’s evaluations and decision-making. EPA is, for example, consideri ng the comparison as an additional source of information to possibly refine the chemical cat egories of nanoscale materials proposed in the material characterization public meeting held in September 2007 ( http://www.epa.gov/oppt/nano/ mc09072007-mtgsummary.pdf ). Because the differences between bulk and nanoscale materials are poorly understood, developing ca tegories of relevant chemicals with similar properties may assist the Agency in developing models to predict relevant physica l-chemical and other properties as they apply to nanos cale materials. Additionally, th e Agency has already used the datasets to identify and reach out to potential stakeholders and will continue these outreach

activities.

18Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



### 6 

## Report on the In

‐ Depth Program Participation

Under the In-Depth Program, EPA invited participants to work with the Agency and others on a plan for the development of data on re presentative nanoscale ma terials over a longer time frame. As December 8, 2008 four companie s have committed to participate thus far; SouthWest NanoTechnologies, Inc., Swan Chemi cals Inc., Unidym, and Selah Technologies.

The nanoscale materials covered are carbon nanotubes and a carbon nanoparticle.

In early 2009, EPA plans to initiate an appr opriate procedure to further discussions with these companies towards the design and implem entation of an In-Depth testing program.

In addition, the American Chemistry Council (A CC) has expressed an interest in working with EPA towards a research prog ram that may help develop a bett er understanding of the risks

of nanoscale materials.

19Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



## 7 Other Relevant Activities in the US Government and Internationally

EPA is providing leadership regarding the de velopment and implementation of regulatory oversight on nanoscale materials that are regulated under TSCA. These efforts have involved a variety of activities for nanoscale materials as described in this report to develop data, engage nationally and internationally wi th other regulatory entities, undertake extensive outreach activities, and regulate new chemical nanoscale ma terials. The NMSP exists in the context of these ongoing data development (re search and testing) and regulat ory programs. At the Agency, overarching research goals were outlined in the February 2007 EPA Nanotechnology White Paper.



## Other Agencies

ORD NRS NNI/NEHI “ Bi-lateral ” 

## OECD WPMN

NMSP

Health and Environmental

Decisions 

## New Chemicals 1 

## Other countries

Figure 9 The NMSP in the context of other research and regulatory programs. The Office of Research and Development (ORD) has developed a Nanomaterial Research Strategy (NRS) that is discussed in Section 7.1.1. The National Nanotechnology Initiative (NNI) has established the Nanotechnology Environmental and Health Implications (NEHI) working group to coordinate federal research on environmental health and safety studies (Section 7.1.2). At the international level, the Organi zation for Economic Co-operation and Development (OECD) has established the Working Party on Manufactured Nanomaterials (WPMN), which is discussed in Section 7.1.3.

1 The NMSP directly interacts with EPA’s regulatory effo rts on new chemical nanoscale materials, which is

addressed in Section 7.2.1.

20Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



### 7.1 Data and Standards Development (Research and Testing)

7.1.1 ORD’s Nanomaterial Research Strategy (NRS)

The purpose of the Nanomaterial Research Strate gy is to guide the EPA’s Office of Research and Development’s program in nanomater ial research. The strategy builds on and is consistent with the

foundation of scientific need s identified by the Nanotechnolog y Environmental and Health Implications Working Group ( http://www.nano.gov/NNI_EHS _Research_Strategy.pdf ), and in the

EPA’s Nanotechnology White Paper ( http://www.epa.gov/osa/pdfs/na notech/epa-nanotechnologywhitepaper-0207.pdf )). The purpose of EPA’s nanotechnolo gy research program is to conduct

focused research to inform decisi ons related to nanomaterial implicat ions and applications that may

be made under the various environmental statutes for which the EPA is responsible. EPA recognizes that the information generated through its resear ch program likely will have use in areas beyond the Agency’s purview. EPA is collaborating acros s the government, industry, and the international community to implement this strategy. EPA’s in -house research program has the capability to leverage results from EPA grant programs, as well as to collaborate with grantees to address the many challenging research issues outlined in this strategy. EPA’s strategy focuses on four areas that take advantage of EPA’s scientific expertise as well as fill gaps not addressed by other organizations.

The four research themes are:

 Identifying sources, fate, transport, and exposure

 Understanding human health and ecological eff ects to inform risk assessments and test

methods

 Developing risk assessment approaches

 Preventing and mitigating risks

Annex A provides a fuller description of the NRS.



### 7.1.2 NNI/NEHI

The 21st Century Nanotechnology Research a nd Development Act resulted in the implementation of The National Nanotechnology Initiative (NNI). The NNI created a framework for a comprehensive nanotechnology R&D program by establishing shared goals, priorities, and strategies (http://www.nano.gov/ht ml/about/home_about.html). The NNI consists of the individual and cooperative nanotechnology-re lated activities of 25 Federal agencies with a range of research and regulatory roles and respon sibilities. The NNI does not itself fund research. Rather, it informs and influences the Fede ral budget and planning processes through NNI’s individual member agencies, each of whic h conducts its own nanot echnology activities, including research, in a manner consistent with its mission. EP A coordinates its nanotechnology research activities with other federal agen cies through the NNI. The Nanoscale Science, Engineering and Technology (NSET) Subcommittee coordinates many of the NNI activities that provide channels for the exchange of information and the formulation of research strategies that accelerate progress towards understanding the risks and benefits of nanotechnology. The Nanotechnology Environmental and Health Impl ications (NEHI) Working Group of the NSET

coordinates research relevant to and practices that protect human h ealth and safety as well as the environment ( http://www.nano.gov/htm l/society/NEHI.html ). The NSET Subcommittee and

21Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

NEHI Working Group provide l eadership in establishing the national nanotechnology environmental, health, and safety research ag enda and in communicating data and information

related to environmental and h ealth aspects of nanotechnology be tween NNI agencies and with the public.



### 7.1.3 OECD

The OECD Council establishe d the Working Party on Manu factured Nanomaterials (WPMN) as a subsidiary body of the Chemicals Committee in September 2006. The Program of

Work of the WPMN can be found at: http://appli1.oecd.org/olis/2008doc.nsf/linkto/env-jmmono(2008)2 . EPA participates in and chairs the WPMN . The WPMN is engaged in a variety of projects to further the understa nding of the properties and potentia l risks of nanoscale materials. (See Annex B for further description) One project involves a Sponsorship Program for Safety Testing a Representative Set of Manufactured Nanomaterials . The program is designed to have sponsors develop a set of testing endpoints for a representative group of 14 commerciallyrelevant nanoscale materials. For more information on the endpoints and the list of

manufactured nanoscale materials see http://appli1.oecd.org/olis/2008doc.nsf/linkto/env-jmmono(2008)13-rev . EPA is sponsoring environmental effe cts and fate testing of fullerenes, single walled carbon nanotubes, mu ltiwalled carbon nanotubes, silv er nanoparticles and cerium oxide as part of the OECD progr am. Annex D lists the 14 representative nanoscale materials and contains a summary of spons ors as of October 13, 2008.



### 7.1.4 International Organization for Standardization Technical Committee 229 (ISO/TC229)

The International Organization for Standard ization (ISO) has esta blished a technical committee to develop international standards for nanotechnology. This technical committee, ISO/TC229, is working to develop standards fo r terminology and nomenclature, metrology and instrumentation, including specifications for re ference materials, test methodologies, modeling and simulation, and science-based health, safe ty and environmental practices. EPA actively participates and contribute s to ISO working groups.



### 7.2 Regulatory and Policy Development

7.2.1 Regulatory Efforts on New Chemical Nanoscale Materials

Under TSCA section 5, notices for chemical s ubstances that have a molecular identity

different from those listed on the TSCA Chemic al Substances Inventor y are required to be submitted to EPA for review prior to commercial manufacture or import. In January, 2008, EPA published a paper on the “TSCA Inventory St atus of Nanoscale Substances – General Approach.” This paper reiterated the Agency’s long-standing application of the definition of

“chemical substance” under TSCA Section 3(2)A that chemical substances that may be available in different physical forms but that have the same molecular identity cons titute a single chemical substance for purposes of the TSCA Inventory and new chemical reporting 7

.

7 Available at: http://www.epa.gov/oppt/nan o/nmsp-inventorypaper2008.pdf

.

22Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

Although the General Approach paper dealt with the case of allotropes of a material as being new chemicals if not listed on the I nventory, the Agency found some confusion among manufacturers particularly with respect to carbon nanotubes (CNTs). EPA subsequently published a Federal Register notice (73 FR 64946) on October 31, 2008 explicitly stating that

CNTs are considered distinct chemical substan ces from graphite or ot her allotropes of carbon listed on the TSCA Inventory. Since January 200 5, EPA has received and reviewed more than fifty new chemical notices under TSCA for na noscale materials including carbon nanotubes and fullerenes. In some cases, new chemical notices were submitted on nanoscale materials following a bona fide intent to manufacture query from a manufacturer to determine the TSCA Inventory status of the substance in question.

Where necessary, the Agency has taken steps to control or limit exposures to nanoscale materials submitted for TSCA new chemical review, including:

• limiting the uses of the nanoscale materials;

• requiring the use of personal protective e quipment, such as impervious gloves and NIOSH approved resp irators; and

• limiting environmental releases.

The Agency has also required testing to genera te health and environmental effects data where appropriate. EPA has permitted limited manufact ure of new chemical nanoscale materials by using administrative orders unde r section 5(e) of TSCA and/or Significant New Use Rules under section 5(a)(2) of TSCA. The Agency has al so allowed limited manufacture of new chemical

nanoscale materials under the term s of certain regulatory exem ptions (fewer than 10 through November 2008), but only in circumstances where exposures were tightly controlled to protect against unreasonable risks (using, for example, specific protective e quipment and stringent environmental release limitations).

The Agency believes the NMSP and other initiativ es described in the previous paragraphs will ultimately provide strong support for ac tivities conducted under EPA’s New Chemicals program. Each submission in the NMSP is unde rgoing a review similar to that of a new chemical. At the current time, EPA has utiliz ed the existing framework of the new chemicals review process with some additional questions specifically designed to deal with nanoscale materials. As part of the revi ew process, EPA is identifying a dditional issues and questions. A full analysis of experience and reviews under the new chemicals program will be included in the final report on the NMSP.



### 7.2.2 Nanotechnology Policy Coordination Group (NPCG)

Recognizing the need for policy coordina tion, EPA proposed and contributed to the establishment of the Federal Nanotechnology Po licy Coordination Group (NPCG). The NPCG identifies, coordinates, and addresses policy que stions associated with nanotechnology issues that affect multiple federal agencies with diverse goals and missions and is co-chaired by Office of Science and Technology Policy and the Council on Environmental Quality. The NPCG has

23Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

contributed to the development and elaborati on of a coordinated federal policy approach, including development of a doc ument entitled “Principles fo r Nanotechnology Environmental, Health, and Safety Oversight”. This document outlined generally applicable principles relevant to oversight for nanotechnology by the Federal government a nd was issued on November 8, 2007. ( http://www.ostp.gov/galleries/defaultfile/Nano%20EHS%20Principle s%20Memo_OSTP-CEQ_FINAL.pdf )



### 7.2.3 Other

There are other offices or federal agencies engaged in regulatory or policy development efforts applicable to nanoscale materials. Fo r example, EPA regulates products intended to control pests under the authority of the Federa l Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Food and Drug Administration us es its authority under the Federal Food, Drug, and Cosmetic Act (FFDCA) to ensure that drugs , drug delivery systems, cosmetics, medical devices, vaccines, and food products reaching the ma rketplace are safe and effective. Regulation of exposure to chemicals in the workplace falls under the Occupational Safety and Health Administration’s general industry standards. The National Institute for Occupational Safety and Health (NIOSH) is responsible for research on and development of recommended occupational exposure levels and work practices. EP A’s implementation of the NMSP gives due consideration to the important ro les of these agencies in evalua ting and addressing the potential risks of nanoscale materials. In addition, EP A is sharing information and experience gained through the NMSP with these agencies.



### 7.2.4 International Policy Coordination Efforts

The OECD WPMN project on Cooperation on Voluntar y Schemes and Regulatory Programs illustrates the benefits of sharing experiences with ot her governments. EPA was able to share internationally the information availa ble through its NPPTAC ov erview document, peer consultations and other experiences in developi ng the NMSP. EPA has also learned from the experience of other countries in developing and implementing voluntar y reporting programs of the necessity for confidentiality, outreach, and dead lines to make such progr ams more successful. EPA has also exchanged information with ot her governments regard ing application of regulations to nanoscale materials.

Other countries’ national chemical progr ams have also begun to address nanoscale materials. For example, the United Kingdom’s Department of Environment, Food, and Rural Affairs established a voluntary reporting progra m similar to the NMSP in September 2006. To date they have received 11 submissions – 9 from industry, 2 from academia 8 . Australia has published a voluntary call for information regard ing the volumes, types and data holdings of

nanoscale materials that are bei ng used within Australia as industrial chemicals in the 2008 calendar year. The voluntary call for information is directed to industry a nd researchers. Canada is developing a mandatory information gathering survey for nanoscale materials under the authority of the Canadian Environmental Pr otection Act of 1999. The European Commission

has determined that nanoscale materials are c overed under the REACH (Registration, Evaluation,

8 Defra, 2008. “The UK Voluntar y Reporting Scheme for Engin eered Nanoscale materials: Seventh Quarterly Update.” Accessed on December 12, 2008 at: http://defra.gov.uk/enviro nment/nanotech/pdf/vrs-s evetnh-progress-report.pdf

.

24Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

Authorization and Restriction of Chemicals) legisl ation and will consider if there is a need for specific REACH regulations as they pertain to nanoscale materials.

25Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



## 8 Conclusions

EPA has received a significant amount of data through NMSP submissions and believes that the NMSP has contributed to a considerably stro nger and better informed understanding of the

issues and commercial status of nanoscale materials in the United States. The Agency is still analyzing those data and expect s to receive additional submissi ons from companies that have committed to participate. Midway through th e program, the Agency considers the NMSP

successful for a number of reasons:

• The participating companies and associations have demonstrated solid commitment to the NMSP’s Basic Program and provided EPA with considerable amounts of valuable data (e.g., material characterization, uses, etc.) th e Agency would not have otherwise obtained in less than a year, including enhancing EPA’s understanding of:

o the risk management practices currently employed by companies for nanoscale materials; and

o nanoscale materials used in research and development, which has contributed to EPA’s Nanomaterial Research Strategy.

• The development and implementation of the NMSP has informed EPA’s regulatory understanding of nanoscale materials, including:

o how to structure and effectively report information on nanoscale materials, including the development and elaborati on on policy guidance which can be used in future regulatory or additional voluntary efforts on nanoscale materials;

o information related to reviews under the TSCA new chemicals program which has helped the Agency identify and follow up with several companies that needed to

file bona fide intent to manufacture no tices or pre-manufacture notices under TSCA for their carbon nanotubes and fullerenes; and

o policy issues relating to possible appro aches and strategies for effectively structuring any needed regulatory requirements.

• The NMSP has better informed the US Govern ment’s participation in the OECD WPMN:

o the experience gained in the NMSP, given the number and variety of submissions, has been a valuable input into the WPMN’s deliberations; and

o the fact that 12 of the 14 major na noscale materials in the OECD WPMN sponsorship program were reported under the NMSP has demonstrated the relevance of the OECD’s sponsorship program as a vehicle for speeding the collaborative development of needed test data and helps confirm that the NMSP Basic Program has captured nanoscale materials of global significance.

• Four companies have committed to support further testing of nanoscale materials in the NMSP In-Depth program which should help to accelerate the development of needed understanding for carbon nanotube s and carbon nanoparticles; and

26Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

• In the aggregate, the NMSP has sufficiently advanced EPA’s knowledge and understanding to enable the Agency to take further steps towards evaluating and, where appropriate, mitigating potential risk s to health and the environment.

The progress made under the NMSP should be temp ered against a number of considerations:

• It appears that nearly two-thirds of the ch emical substances from which commercially

available nanoscale materials are based we re not reported under the Basic Program.

• It appears that approx imately 90% of the different nanosca le materials that are likely to be commercially available were no t reported under the Basic Program.

• There is some uncertainty regarding whether each NMSP participant reported all of the

nanoscale materials it manufactures and there may be gaps in the data reported by each participant. Review of NMSP submissions re veal a number of instances where the details of the manufacturing, processing, and use of nanoscale materials were not reported.

• A number of the NMSP submissions did not co ntain exposure or hazard-related data. Exposure and hazard data are two of the majo r categories of information EPA identified in its concept paper for the NMSP that are n eeded to inform risk assessment and risk management of nanoscale materials.

• The low rate of engagement in the In-Depth Program sugge sts that most companies are not inclined to voluntarily te st their nanoscale materials.

• The need for additional progress towards addr essing NPPTAC's considerations discussed

in Section 3.1 of this report. For example:

o A higher rate of participation;

o An increased amount of information from program participants, where applicable;

o Understanding the adequacy and potential eff ectiveness of existing risk management practices; and

o Developing additional lessons and conc lusions from the program experience, including:

o What are the characteristics of nanoscale substances that should be considered in risk assessment and risk management;

o Which, if any, regulatory changes ma y be needed to address nanoscale materials; and

o What further risk management practices are appropriate for nanoscale

substances?

27Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



## 9 Next Steps

The NMSP is scheduled to run until January 2010. EPA welcomes new participants and

will continue its outreach to nanoscale materi als manufacturers and im porters through regional, national, and international conferences, meetings and calls. The Agency will continue to identify and inform companies of their obligations under TSCA for new chemical nanoscale materials.

EPA will initiate discussions with In-D epth participants. The Agency strongly encourages others to participate in the program as it develops. EPA will review the data gaps revealed by the NMSP in the context of other national and international data development initiatives, to inform the design and de velopment of the In-Depth program.

EPA will continue to evaluate the Basic Program submissions, including information on risk management practices, to identify characte ristics of nanoscale materials that should be considered in risk assessment as well as approaches for risk management. EPA will continue developing the comparison of comme rcially-relevant nanoscale mate rials and refining categories

of nanoscale materials based on molecular identi ty and physical propertie s in order to better understand their behavior and help prioritize resear ch and regulatory efforts. The Agency will ultimately incorporate this information into it s new and existing chemical review process.

EPA will consider how to best apply regulat ory approaches under TSCA section 8(a) to address the data gaps on existing chemical na noscale material production, uses and exposures that were identified through this analysis of the Basic Program information. Due to the limited participation in the In-Depth Program, EPA will also consider how best to apply rulemaking under TSCA section 4 to develop needed enviro nmental, health, and safety data. Such rulemaking would give due consid eration to testing planned or underway in other forums, e.g. OECD and In-Depth program, and ORD and NNI research.

EPA may adjust or decide ne xt steps for the NMSP as experi ence or test data warrant.

This includes:

o The Agency will take any necessary action to prevent unreasonable risks to human health and the environment. EPA has not yet id entified any NMSP submissions that would warrant those types of actions.

o The Agency will issue a more detailed report on the NMSP in January 2010 and decide on any additional NMSP activities as appropriate.

The Agency welcomes comments on this inte rim report, and will use those comments, as appropriate, in further refini ng the NMSP and in the development of the final NMSP report.

28Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



## 10 Annex A ‐ Summary of EPA Nanomaterial Research Strategy

The Nanomaterial Research Strategy (NRS ) describes the Environmental Protection Agency’s (EPA) strategy for conducting and s upporting research to unde rstand the potential human health and ecological (henceforth referred to jointly as “environmental”) implications from exposure to manufactured nanomaterials, and how nanotechnology can be used in environmental protection applications. EPA has wr itten this document with three main purposes: (1) to guide its own researchers and managers as they conduct EP A’s research program, (2) to assist scientists in other orga nizations as they plan their own research programs, and (3) to inform the public of how EPA intends to generate scientific information to guide environmental

decisions related to nanomaterials.

The purpose of EPA’s research program in support of the National Nanotechnology Initiative

is to conduct focused research to address ri sk assessment and risk management needs for nanomaterials in support of the various environm ental statutes for which the EPA is responsible. This program will be coordinated with research conducted by other federal agencies, where the

EPA will lead selected research areas and rely on research produc ts under the leadership of its federal research partners in ot her research areas. Co llaboration is encouraged among researchers across the government, industry, and the intern ational community. EPA’s in-house research program has the capability to leverage results from EPA grant programs, as well as to collaborate with grantees to address the many challenging research issues outlined in this strategy.

The NRS focuses on developing scientific info rmation for nanomaterial decision support. However, because other entities also conduct research related to nanomaterials and the environment, EPA is focusing on four areas that ta ke advantage of EPA’s sc ientific expertise as well as fill gaps not addressed by other orga nizations. The four re search themes are:

 Identifying sources, fate, transport, and exposure

 Understanding human health and ecological eff ects to inform risk assessments and test

methods

 Developing risk assessment approaches

 Preventing and mitigating risks

EPA believes that its research should advance two key objecti ves: (1) the development of approaches for identifying and addressing any haza rdous properties, while maintaining beneficial properties, before a nanomaterial enters the environment; and (2) iden tifying whether, once a nanomaterial enters the environment, it presents environmental risks. EPA will pursue these objectives from a life-cycle perspective—i.e., by understanding where en vironmental impacts may occur, and where benefits may be attaine d, throughout a nanomaterial’ s existence: from its production, through its use in products, and as it is disposed of or recycled.

ORD is focusing its initial in-house research on seven manuf actured nanomate rials: singlewalled carbon nanotubes, multi-walled carbon nanot ubes, fullerenes, cerium oxide, silver, titanium dioxide, zero-valent iron. Ultimately, ORD has as a goal the development of predictive

29Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

models and tools that will enable testing acro ss these material classes, since testing the many potential variations of materials within each of these seven classes would be very resource

intensive.

ORD selected these seven material types based on the materials’ current use in products, the near-term needs of EPA’s program and regional offices, research underway at other federal agencies, and the materials selected for testi ng in the OECD’s Working Party on Manufactured Nanomaterials. Over time, ORD expects to ex tend its efforts to other material types.

ORD evaluated several key issues and activities to identify priorities for the research program. The program will be problem-driven and focused on addressing EPA’s needs. Also research

recommendations from the EPA Nanotechnology White Paper and research coordination leadership in the NNI Strategy (2008) were important considerations. Defining questions are:

 Does the research support EPA’s mission to pr otect human health and the environment?

 Is the research important to support EP A regulatory decisions on nanomaterials?

 What is the role EPA played in leading/coor dinating this research topic under the NNI EHS strategy (2008)?

 Is the research part of an international agreement to coll aborate and leverage research

activities?

 What research themes are important to s upport Agency risk assessment and management

activities?

 How do partnerships with federal, academic , and industry researchers enhance research

activities?

Having considered these questions within the context of resource constraints and research being conducted by other organizations, ORD has focu sed its nanotechnology research program on the four research themes described above. The EPA research program will address key science questions.

Theme 1: Sources, Fate, Transport, and Exposure

• What technologies exist, can be modified, or must be developed to detect and quantify

manufactured nanomaterials in enviro nmental media and biological samples?

• What are the major processes and/or prope rties that govern the environmental fate, transport, and transformation of manufactured nanomaterials, and how are these related to the physical and chemical pr operties of those materials?

• What are the exposures that will result from releases of manufactured nanomaterials?

Theme 2: Human Health and Ecological Research to Inform Risk Assessment and Test Methods

• What are the effects of manufactured nanom aterials and their a pplications on human health, and how can these effects be best quantified and predicted?

• What are the effects of manufactured nanomat erials and their app lications on ecological receptors, and how can these effects be best quantified and predicted?

30Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

Theme 3: Risk Assessment Methods and Case Studies.

• In what ways, if at all, do risk assessment approaches need to be amended to incorporate special characteristics of manufactured nanomaterials?

Theme 4: Preventing and Managing Risks

• Which manufactured nanomaterials have a hi gh potential for release from a life-cycle perspective and what practices can be appl ied to minimize the risks of nanomaterials throughout their life cycle?

• How can manufactured nanomaterials be a pplied for treatment and remediation of contaminants, and what decision-making me thods need to be developed for risk management of nanomaterials?

The research described in the NRS will be implemented through multi-year plans (MYP). The Office of Research and Development’s rese arch multi-year plans present the long-term strategic vision of the EPA’s research pr ograms. The MYPs serve as a planning and

communication tool to describe the scope of research addr essing EPA’s priority science questions. The MYPs are also used to help (1) demonstrate how ORD’s research programs contribute to Agency outcomes and strategic goals; (2) provide in formation to aid in and support decisions during budget formulation; and (3) assi st in managing performance and accountability reporting, including the OMB Program Asse ssment Rating Tool (PART) review.

31Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



## 11 Annex B ‐ Description of OECD Working Party on Manufactured

Nanomaterials

In 2006, OECD’s Chemicals Committee agreed to a Program of Work on Manufactured Nanomaterials. This Program of Work is addr essing human health and environmental safety aspects of manufactured nanomaterials. The Ch emicals Committee also established a Working Party on Manufactured Nanomaterials (WPMN) to implement its Program of Work. The objective of the WPMN is to promote inte rnational cooperation in human health and environmental safety related aspe cts of manufactured nanomaterials (MN), in order to assist in the development of rigorous safety evaluation of nanomaterials. The work is being implemented through eight projects listed below:

• Development of a Database on Human Health and Environmental Safety Research; • Research Strategies on Manufactured Nanomaterials; • Safety Testing of a Represen tative Set of Manufactured Nanomaterials; • Manufactured Nanomaterials and Test Guidelines; • Cooperation on Voluntary Schemes and Regulatory Programs; • Cooperation on Risk Assessment;

• The Role of Alterna tive Methods in Nanotoxicology; and • Exposure Measurement and Exposure Mitigation

These eight projects are being managed by ei ght steering groups which are implementing their “operational plans”, each with their spec ific objectives and timelines. These steering groups (which average around 20 pa rticipants) are being led/ ch aired by members of the WPMN, with support from the OECD Secretariat. Much of the work has been (and is being) undertaken through teleconferences and electr onic means. At the same tim e, there are close linkages among the projects, and for this reason, “face-to-face” meetings of steering groups are organized as the

need arise. Results of each project are then evaluated a nd endorsed by the entire WPMN.

32Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



## 12 Annex C ‐ Current NMSP Participants (as of December 8, 2008)

Table 1

Company Name Chemical Name

Ahwanee multi-walled carbon nanotubes (MWCNT)

Altairnano lithium titanate

Arkema MWCNT BASF Corporation 1. butyl acrylate polymer 2. butadiene styrene copolymer 3. polymer

4. titanium dioxide 5. confidential business information (CBI)

6. CBI

7. CBI

Bayer Material Science CBI

Dow Chemical 1. CBI

2. CBI

3. CBI

DuPont 1. titanium dioxide 2. poly-(ethylene tereph thalate) resin with sepiolite clay Evonik/Degussa 1. titanium oxide

2. aluminum oxide

General Electric 1. antimony pentoxide 2. dimethyl siloxide, reaction product with

silica 3. silanamine, 1,1,1-thrimethyl-n- (thrimethylsilyl) hydrolysis product with silica

4. silver

International Carbon Black Association carbon black

Nano-C fullerenes (4 chemicals)

Nanofilm acrylic coating Nanophase Technologies Corporation 1. iron oxide

2. aluminum oxide

3. cerium oxide

Nantero CBI

Office ZPI cluster diamonds

PPG Industries 1. amorphous silica

2. CBI

33Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



### Company Name Chemical Name

Pressure Chemical 1. CBI

2. CBI

3. CBI Quantum Sphere manganese/manganese oxide

Sabic Plastic Innovations CBI

CBI

Sasol North America aluminum oxide hydroxide (3 materials) Selah Technologies, Inc. carbon nanoparticles

Showa Denko KK MWCNT SouthWest Nano Technologies, Inc. carbon nanotube (CNT)

Strem Chemicals aluminum oxide magnesium oxide

calcium oxide calcium oxide(high surface area) cerium (IV) oxide copper (II) oxide magnesium oxide magnesium oxide (high surface area) titanium (IV) oxide

zinc oxide MWCNT (5 chemicals) Single-walled ca rbon nanotubes (SWCNT) gold nanochain (AuNP)

AuNP embedded sticky gold nanoparticles sugar-coated gold nan oparticles (4 materials) gold nanorods gold triangles, hexagons, polygons, and rods (3 materials) water-soluble gold particles (4 materials) AuNP 30-40nm (starch) water soluble gold nanoparticles c itrates, (4 materials) AuNP 11-20nm (gelatin) Palladium nanoparticles, 1-5nm, PdNP (starch) PdNP, 2-3 (gelatin) PdNP, 2-4nm (gum arabic) platinum nanoparticles, PtNP (gum arabic) AgNP,10-15 nm, starch AgNP, 5-10 (gum Arabic) AgNP, 5-10 nm (gelatin) platinum, 2-5nm cobalt nanoparticles gold/tetra-n-octyla mmonium chloride colloid rhodium/tetra-n-octylammonium chloride

34Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



### Company Name Chemical Name

Strem Chemicals, cont. colloid purified (70-75% Rh) cobalt magnetic fluid in kerosenes with AOT (sodium dioctylsulfosuccinate) and LP4 (a fatty acid condensation polymer) platinum-rhuteniu m/tetra-n-octylammonium

chloride colloidrhodium colloid (polyethyleneglycoldodecylether, hydrosol) iron-cobalt nanopar ticles (surfaced modified with L-cysteine ethyl ester)(wet with ethanol) platinum-ruthenium colloid (polyethyleneglycol- dodecylether,hydrosol) nickel/tetra-n-octyla mmonium chloride colloid, purified (65-70%) iron-cobalt magnetic fluid in toluene stabilized with cashew nut liquid platinum/tetra-n-octylammonium chloride colloid purified (70-85 Pt)cobalt nanoparticles (surfaced modified with Lcysteine ethyl ester)(wet with ethanol) platinum colloid (polyethyleneglycoldodecylether,hydrosol) cobalt nanoparticles, toluene wet titanium cluster, tetrahydofuran adduct (30- 35% Ti) diphenyl(m-sulfonatophenyl)phosphine-gold nanocluster (water soluble) (1-3 nm) platinum, min.90%, (5-13 nm) cobalt nanoparticles coated with AOT (sodium dioctylsulfosuccinate) 10-12 nm titanium cluster, tetrahydofuran adduct (20- 25% Ti)

Swan Chemicals MWCNT

SWCNT Synthetic Amorphous Silica and Silicate Industry Association Synthetic Amorphous Silica

Unidym CNT CBI Company 1 CBI CBI Company 2 CBI

35Nanoscale Materials Stewardship Pr ogram Interim Report January 2009



## 13 Annex D ‐ OECD Sponsorship Program for the Testing of

Manufactured Nanomaterials (MN)

Current Sponsors (as of 13 October 2008 i )

Representative

Set of MN ii Lead sponsor(s) iii Co-sponsor(s) iv Contributors v

Fullerenes(C60) Japan

United States Denmark

China

SWCNTs Japan

United States Canada

France Germany

EC

China

BIAC

MWCNTs Japan

United States Korea

BIAC Canada Germany

France

EC

China

BIAC

Silver nanoparticles Korea

United States Canada Germany

Nordic Council of

Ministers Australia

France

EC

China

Iron nanoparticles China BIAC Canada

US

Nordic Council of

Ministers

36Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

37 Representative

Set of MN vi Lead sponsor(s) vii Co-sponsor(s) viii Contributors ix

Carbon black Denmark Germany

US

Titanium dioxide Germany Canada

Korea Spain

United States

BIAC Denmark

China

Aluminum oxide Germany

United States

Cerium oxide United States

United Kingdom/BIAC The Netherlands Australia Germany

EC

Zinc oxide United Kingdom/BIAC United States

BIAC Australia

Canada

Silicon dioxide EC Korea

BIAC Denmark

France
Polystyrene Korea

Dendrimers Spain United States

Nanoclays Denmark

United States

i The sponsors arrangement is under development there the table of current sponsors will be

revised as new information becomes available.

ii The phrase “representative nanomaterials” was intended to mean those manufactured

nanomaterials (MNs) now or soon to enter into commerce. See LIST OF MANUFACTURED

NANOMATERIALS AND LIST OF ENDPOINTS FOR PHASE ONE OF THE OECD TESTING

PROGRAMME [ ENV/JM/MONO(2008)13/REV ]

iii Lead Sponsor(s) assume responsibility for conducting or coordinating all of the testing

determined to be appropriate and feasible to address the endpoints of Phase 1 for a listed

nanomaterial. In some cases, “joint lead” arrangements may be developed where appropriate

and considering the degree of participation committed toward addressing endpoints.

iv Co ‐ Sponsor(s) conduct some of the testing determined to be appropriate and feasible to

address the endpoints of Phase 1 for a specific listed nanomaterial.Nanoscale Materials Stewardship Pr ogram Interim Report January 2009

38 v A Contributor provides test data, reference or testing materials or other relevant information

to the lead and co

‐ sponsors.

vi The phrase “representative nanomaterials” was intended to mean those manufactured

nanomaterials (MNs) now or soon to enter into commerce. See LIST OF MANUFACTURED

NANOMATERIALS AND LIST OF ENDPOINTS FOR PHASE ONE OF THE OECD TESTING

PROGRAMME [ ENV/JM/MONO(2008)13/REV ]

vii Lead Sponsor(s) assume responsibility for conducting or coordinating all of the testing

determined to be appropriate and feasible to address the endpoints of Phase 1 for a listed

nanomaterial. In some cases, “joint lead” arrangements may be developed where appropriate

and considering the degree of participation committed toward addressing endpoints.

viii Co ‐ Sponsor(s) conduct some of the testing determined to be appropriate and feasible to

address the endpoints of Phase 1 for a specific listed nanomaterial.

ix A Contributor provides test data, reference or testing materials or other relevant information

to the lead and co

‐ sponsors.