NANOSCALE MATERIALS 

STEWARDSHIP PROGRAM 

Interim Report 

January 2009 

U.S. Environmental Protection Agency 

Office of Pollution Prevention and Toxics 
Nanoscale Materials Stewardship Program 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 represent 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 policies and regulations; however, this report should not be used as a 

substitute for existing policy documents and regulations. Further, all classifications and 

comparisons in the report represent the best information 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 Materials 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 submitting 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 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

1 Executive Summary

The Nanoscale Materials Stewardship Program (NMSP) was developed to help provide a 

firmer scientific foundation for regulatory decisions by encouraging submission and 

development of information for nanoscale materials. 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 and program evaluation at the conclusion of the 

NMSP in early 2010. 

Under the Basic Program, EPA invited participants to voluntarily report available 

information by July 29, 2008 on the engineered nanoscale materials they manufacture, import, 

process or use. By that date, the Agency received submissions from 16 companies and trade 

associations covering 91 different nanoscale materials. As of December 8, 2008, twenty-nine 

companies or associations submitted information 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 available for nanoscale materials already reported or 

to identify additional nanoscale materials to report under the Basic Program. 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 representative nanoscale materials 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 Control Act to help address those gaps. 

EPA will continue to review new chemical 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 section 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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Nanoscale Materials Stewardship Program Interim Report January 2009 

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 In­Depth Program Participation...............................................................19

7 Other Relevant Activities in the US Government and Internationally.....................20

7.1 Data 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 Committee 229 (ISO/TC229)

  22

7.2 Regulatory 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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Nanoscale Materials Stewardship Program Interim Report January 2009 

2 Introduction  

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

health and the environment. Under the Toxic Substances Control Act (TSCA), EPA has the 

obligation to ensure that potential risks are adequately understood and controlled to protect 

human health and the environment. The same special properties that make nanoscale materials 

useful are also properties that may cause some nanoscale materials to pose potential risks to 

humans and the environment, under specific conditions. At this point not enough information 

exists to fully assess these risks. This information is important because EPA will need a sound 

scientific basis for assessing and managing any unforeseen future impacts resulting from the 

introduction of nanoscale materials into the environment. A challenge for environmental 

protection is to help fully realize the societal benefits of nanotechnology while identifying and 

minimizing any adverse impacts to humans or ecosystems from exposure to nanoscale materials. 

 The growing diversity and complexity of the types and uses of nanoscale materials 

available and being developed presents challenges in evaluating 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 toxicity 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 relate to nanoscale materials will be necessary 

for EPA to evaluate and manage any potential risks: chemical identification and physical 

properties characterization, environmental fate, environmental detection and analysis, human and 

environmental exposure, human health effects, and 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 nanoscale materials, as well as in environmental 

detection, monitoring, and clean-up. 

 

This understanding will come from scientific information generated by environmental 

research and development activities within government 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 Nanotechnology Initiative will sponsor some of this research. 

Individual agencies such as the National Institute for Occupational Safety and Health (NIOSH) 

and EPA are currently conducting this type of research. The Organization for Economic Cooperation and Development (OECD) will spur further research through its Sponsorship Program 

for Safety Testing a Representative Set of Manufactured Nanomaterials. Manufacturers and 

users of nanoscale materials will also develop this information. TSCA clearly states in section 

2(b)(1) that it is the responsibility of manufacturers to develop such information for chemical 

substances they manufacture. 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

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 regulatory activities on nanoscale materials. The 

program was designed to help the Agency gather existing data and information from 

manufacturers, importers, processors, and users 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 materials. 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 determine next steps in development of 

environmental health and safety data and appropriate regulatory actions under TSCA. EPA 

believes that participation in the NMSP will encourage responsible development of nanoscale 

materials and will benefit all stakeholders. EPA views the data development efforts under the 

NMSP to be an important integral component 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 potential voluntary pilot program 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 and Toxics Advisory Committee (NPPTAC), to 

develop 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 TSCA and nanoscale materials, including possible elements of an 

EPA voluntary program for existing chemical nanoscale materials

(http://www.epa.gov/oppt/npptac/pubs/nanowgoverviewdocument20051125.pdf). The document 

was submitted by the NPPTAC to EPA for its consideration in November 2005. 

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

or has achieved its overall goal and other objectives would 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; 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

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

o Risk management practices appropriate to nanoscale substances. 

The Overview Document stated that a voluntary stewardship program was an important 

early step in assisting EPA to assess and address potential risks of engineered nanoscale 

materials and that a high level of participation and cooperation will provide the public with 

greater assurance that engineered nanoscale materials will be managed in a responsible and 

accountable manner. A key outcome of the proposed voluntary program would be to “provide 

the information and experience necessary to develop an overall approach to the treatment of 

nanoscale chemical substances under TSCA...” 

3.2 Development of the NMSP

 EPA subsequently undertook to develop a voluntary stewardship program for nanoscale 

materials generally following the approach suggested by the NPPTAC document. EPA 

conducted a scientific public peer 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 practices. One point of general agreement was that 

EPA should continue to work closely with NIOSH regarding risk management practices for 

nanoscale materials. EPA continues to consult with NIOSH, especially regarding risk 

management practices for new chemical nanoscale materials. 

In July 2007 (http://www.epa.gov/fedrgstr/EPA-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 solicit 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 second scientific public peer 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 information and contained a series of questions on 

discussion topics for the material characterization of nanoscale materials. Discussions 

surrounding those questions informed EPA of data elements that are important for material 

characterization. Several panel members specifically mentioned surface modification as a 

potentially important data element. Multiple panelists discussed their view that virtually all 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

properties have some importance. Some panelists commented that because there is a lack of 

information regarding potential effects associated with exposure to nanoscale materials, EPA 

should attempt to acquire as much information as possible rather than limiting the effort to 

investigate certain properties. Other panelists acknowledged that all 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 likely 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 Program and an In-Depth Program: 

 

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

chemical nanoscale materials to submit existing information on their nanoscale materials, 

i.e., physical and chemical properties, hazard, 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 engineered nanoscale materials to participate. 

• Under the In-Depth Program, EPA 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 choose 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 completion, 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 description of the WPMN). 

 EPA conducted an extensive outreach campaign to educate and encourage participation 

in the NMSP. In addition to the Federal Register notices, public meeting, and two peer 

consultations discussed above, the Agency reached out to over 150 individual companies and 11 

trade associations through letters, 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 federal agencies to get their input and to encourage federal and 

non-federal researchers to participate in the program. 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

4 Summary of Data Received under the Basic Program

 Under the Basic Program, EPA invited participants to voluntarily report available 

information by July 28, 2008 on the engineered nanoscale materials they manufacture, import, 

process or use. By that date, the Agency received submissions from 16 companies and trade 

associations covering 91 different nanoscale materials based on 47 different chemicals1. The 

comparative work in this report is based only on submissions received by September 1, 20082

and includes submissions from 21 companies and trade associations and on 106 nanoscale 

materials based on 52 different chemicals. A listing of participating 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 submissions and, when supplied by NMSP participants, 

sanitized versions of confidential submissions on the website. The information and results 

presented in this section are 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 (realized or projected), basic manufacturing and 

processes as well as risk management practices. However, very few submissions 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 report 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 relative commercialization 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 nanoscale material issues including 

environmental fate, toxicity, and physical-chemical properties in comparison to 

the bulk scale. The Agency anticipates drawing 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 companies and trade associations have submitted 

information to EPA covering 123 nanoscale materials based on 58 different chemicals. Another 

seven companies have committed to submit information. 

2

 Technical challenges with repeating the comparison as new submissions continue to be 

received prevents on-they-fly updates. 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

 Figure 1 illustrates the number 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 “nanoscale materials” 

throughout this report. “Chemical substances”, as defined under TSCA, are distinguished by 

unique molecular identities, and, in this report, are referred to as chemicals. This issue is 

discussed in more detail in the EPA paper 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 other 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 substance 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 molecular 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 materials include research, precommercial, and commercial nanoscale substances and may be different chemicals (e.g. anatase 

titanium dioxide and rutile titanium dioxide) or that are different 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 material whose overall material size was greater than 

100 nanometers (nm) but which contained active structures 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 NMs

Number

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 least one commercial nanoscale material 

submission for the majority of cases. 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

 Although not being able to identify the specific molecular identity of all nanoscale 

materials provided, the Agency has identified 18 nanoscale materials in the NMSP submissions 

as potentially being “new” chemicals under TSCA; these, include nanoscale materials that are at 

the research and development stages. As the molecular identities of many submissions are 

incomplete, any designations of a chemical or nanoscale material as “new” or “existing” in this 

report is based solely on the best available information and is not a determination for regulatory 

purposes. 

 For initial comparative purposes, Figures 2 and 3 group the NMSP nanoscale 

materials by general chemical category and general physical shape, respectively, noting the 

breakdown of commercial versus R&D as in Figure 1. 

 

0

10

20

30

40

50

Other

Nanoclays

Organic

molecules

Organic

polymer

Amorphous

silica

Carbon

Metal

oxides

Metals

Number 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 utility or completeness of the data elements of the 

submissions; this analysis will be provided in the final report of the NMSP. 

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Nanoscale Materials Stewardship Program 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 element Percent of NMs 
Nanoscale Materials Stewardship Program 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 comprehensive database of nanoscale materials, which 

is a critical need for better understanding the universe of commercially available nanoscale 

materials. Consequently, over the past several months, EPA developed a baseline of the 

nanoscale materials that are apparently commercially-relevant in the United States. In 

developing this baseline, EPA evaluated two well-recognized data sources3 for nanoscale 

materials, the Nanowerk Nanomaterials Database and the Wilson Center Project on Emerging 

Nanotechnologies (PEN) Inventory of Nanomaterials 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 preliminary and may change as the Agency receives 

more information and finalizes its assessment of the NMSP submissions and the underlying 

datasets. 

 

5.1 Limitations of the Comparison

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

Nanowerk and Wilson Center databases; 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 publishes information on nanoscale materials that 

are available for commercial and research sale. The Nanowerk database does not, for example: 

distinguish between research and commercial use; regularly update the availability of the listed 

nanoscale materials from the companies listed; or verify the characterization data provided by 

the companies. Furthermore, not every material that 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 analogous to carbon fullerenes, nanoclays, and 

dendrimers). 

The Wilson Center PEN collects, catalogs, and publishes information on commercial 

products for which the manufacturer makes a reasonable claim or appears to make a claim that 

the product contains nanoscale materials. The PEN database does not verify whether a particular 

product actually does contain nanoscale materials nor does it always provide the specific 

molecular identity and form of a particular nanoscale material for verification. Commercial 

 

3

 Further data sources under consideration by EPA for its ongoing analyses include: 

Environmental Working Group Survey of Nano-Scale Ingredients in Cosmetics, the National 

Nanotechnology Initiative and EPA reports on nanoscale materials, results of similar initiatives 

in other countries reported through the OECD WPMN, and from searching scientific literature 

and company promotional websites. 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

products that are not advertised by manufacturers to contain nanoscale materials are not likely 

included in the database. 

It is important to note that many of the products 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 include every supplier or every commercial form of a 

nanoscale material that may be available for sale. 

5.2 Comparison Results

At the Agency’s request, the Nanowerk data were graciously provided by Nanowerk LLC 

as of July 15, 2008, with some data removed to protect intellectual property. The Agency did not 

remove non-US companies from the comparison because the substances may be available for 

import into the US. As part of the comparison, 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 identity, 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 identified 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 nanoscale materials from the other sources. 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 products (77%) for a total of 566 nanoscale materials (some products 

appeared to contain multiple 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 1st, 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 commercial product forms for this interim report 

largely because, in reviewing individual nanoscale materials it became clear that a high 

proportion were likely to be “made to order” and/or available only for R&D, particularly when 

only one or a few forms were listed. EPA would like to better refine this baseline approach for 

the final report, and would welcome comments 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 nanoscale material in 63 products, based on available 

14
Nanoscale Materials Stewardship Program Interim Report January 2009 

of a nanoscale material in a single commercial product to be sufficient for meeting the threshold 

of commercial-relevance. Using this threshold, 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 nanoscale 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 nanoscale 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 commercial status and whether the nanoscale material 

is on the TSCA Inventory (i.e., “existing”). Comparing either the Nanowerk or PEN datasets to 

the submissions received under the NMSP demonstrates 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 between the different datasets of existing 

chemicals and existing commercially-relevant ones, respectively. EPA found a total of 234 

unique existing chemicals with Nanowerk having 199, PEN with 48, and the NMSP with 34. 

The diagrams indicate that each dataset contains 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 nanoclays or polymers) for which a 

specific molecular identity could not be ascertained. 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. 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

nanoscale exclusive to that dataset: 85% in Nanowerk, 46% in PEN, and 26% in the NMSP. 

EPA found a total of 91 unique commercially-relevant existing chemicals with Nanowerk having 

54, PEN with 48, and the NMSP with 15. The diagrams 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 significant challenge and follow-up activity is to 

determine the uniqueness of substances for which 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 has a significant proportion 

of chemicals unique to that dataset, 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 substances common to all three datasets of existing 

chemicals (Figure 8) are targeted for testing. Only 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 nanotube 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 increased. They are treated as 

‘new’ chemicals, however, and therefore are not included in the existing chemicals analysis. Number of Chemicals 

 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

Figure 7 Overlap of existing chemicals between the Nanowerk, PEN, and NMSP datasets. 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 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

5.3 Summary and Next Steps of the Comparison

Combining all three datasets, EPA identified over 200 existing chemicals 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 chemicals 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 production – the rest were R&D submissions. 

The NMSP also included four submissions on existing commercial chemicals 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 chemicals 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 priorities discussed in Section 7.1.3), the Agency has identified 

additional commercially available nanoscale materials that would not meet the likely commercial 

production thresholds from the Nanowerk and PEN datasets 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, considering the comparison as an additional source of 

information to possibly refine the chemical categories 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 categories of relevant chemicals with similar properties may 

assist the Agency in developing models to predict relevant physical-chemical and other 

properties as they apply to nanoscale materials. Additionally, the Agency has already used the 

datasets to identify and reach out to potential stakeholders and will continue these outreach 

activities. 

 

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Nanoscale Materials Stewardship Program 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 representative nanoscale materials over a longer 

time frame. As December 8, 2008 four companies have committed to participate thus far; 

SouthWest NanoTechnologies, Inc., Swan Chemicals Inc., Unidym, and Selah Technologies. 

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

 In early 2009, EPA plans to initiate an appropriate procedure to further discussions with 

these companies towards the design and implementation of an In-Depth testing program. 

 In addition, the American Chemistry Council (ACC) has expressed an interest in working 

with EPA towards a research program that may help develop a better understanding of the risks 

of nanoscale materials. 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

7 Other Relevant Activities in the US Government and Internationally

EPA is providing leadership regarding the development 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 with other regulatory entities, undertake extensive outreach 

activities, and regulate new chemical nanoscale materials. The NMSP exists in the context of 

these ongoing data development (research and testing) and regulatory 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 Chemicals1

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 Organization 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 efforts on new chemical nanoscale materials, which is 

addressed in Section 7.2.1. 

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Nanoscale Materials Stewardship Program 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 Strategy is to guide the EPA’s Office of Research and 

Development’s program in nanomaterial research. The strategy builds on and is consistent with the 

foundation of scientific needs identified by the Nanotechnology 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/nanotech/epa-nanotechnologywhitepaper-0207.pdf)). The purpose of EPA’s nanotechnology research program is to conduct 

focused research to inform decisions related to nanomaterial implications 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 research program likely will have use in areas beyond the 

Agency’s purview. EPA is collaborating across 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 effects 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 and 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/html/about/home_about.html). The NNI consists 

of the individual and cooperative nanotechnology-related activities of 25 Federal agencies with a 

range of research and regulatory roles and responsibilities. The NNI does not itself fund research. 

Rather, it informs and influences the Federal budget and planning processes through NNI’s 

individual member agencies, each of which conducts its own nanotechnology activities, 

including research, in a manner consistent with its mission. EPA coordinates its nanotechnology 

research activities with other federal agencies 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 Implications (NEHI) Working Group of the NSET 

coordinates research relevant to and practices that protect human health and safety as well as the 

environment (http://www.nano.gov/html/society/NEHI.html). The NSET Subcommittee and 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

NEHI Working Group provide leadership in establishing the national nanotechnology 

environmental, health, and safety research agenda and in communicating data and information 

related to environmental and health aspects of nanotechnology between NNI agencies and with 

the public. 

7.1.3 OECD

The OECD Council established the Working Party on Manufactured 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 understanding of the properties and potential 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 effects and fate testing of fullerenes, 

single walled carbon nanotubes, multiwalled carbon nanotubes, silver nanoparticles and cerium 

oxide as part of the OECD program. Annex D lists the 14 representative nanoscale materials and 

contains a summary of sponsors as of October 13, 2008. 

7.1.4 International Organization for Standardization Technical Committee 229

(ISO/TC229)

The International Organization for Standardization (ISO) has established a technical 

committee to develop international standards for nanotechnology. This technical committee, 

ISO/TC229, is working to develop 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. EPA actively 

participates and contributes 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 substances that have a molecular identity 

different from those listed on the TSCA Chemical Substances Inventory 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 Status 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 constitute a single chemical 

substance for purposes of the TSCA Inventory and new chemical reporting7

. 

 

7

 Available at: http://www.epa.gov/oppt/nano/nmsp-inventorypaper2008.pdf. 

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Nanoscale Materials Stewardship Program 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 Inventory, 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 substances from graphite or other allotropes of carbon 

listed on the TSCA Inventory. Since January 2005, EPA has received and reviewed more than 

fifty new chemical notices under TSCA for nanoscale 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 equipment, such as impervious gloves and 

NIOSH approved respirators; and 

• limiting environmental releases. 

The Agency has also required testing to generate health and environmental effects data where 

appropriate. EPA has permitted limited manufacture of new chemical nanoscale materials by 

using administrative orders under section 5(e) of TSCA and/or Significant New Use Rules under 

section 5(a)(2) of TSCA. The Agency has also allowed limited manufacture of new chemical 

nanoscale materials under the terms of certain regulatory exemptions (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 equipment and stringent 

environmental release limitations). 

 

The Agency believes the NMSP and other initiatives described in the previous paragraphs 

will ultimately provide strong support for activities conducted under EPA’s New Chemicals 

program. Each submission in the NMSP is undergoing a review similar to that of a new 

chemical. At the current time, EPA has utilized the existing framework of the new chemicals 

review process with some additional questions specifically designed to deal with nanoscale 

materials. As part of the review process, EPA is identifying additional 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 coordination, EPA proposed and contributed to the 

establishment of the Federal Nanotechnology Policy Coordination Group (NPCG). The NPCG 

identifies, coordinates, and addresses policy questions 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 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

contributed to the development and elaboration of a coordinated federal policy approach, 

including development of a document entitled “Principles for Nanotechnology Environmental, 

Health, and Safety Oversight”. This document outlined generally applicable principles relevant 

to oversight for nanotechnology by the Federal government and was issued on November 8, 

2007. (http://www.ostp.gov/galleries/defaultfile/Nano%20EHS%20Principles%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. For example, EPA regulates products intended to 

control pests under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act 

(FIFRA). The Food and Drug Administration uses 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 marketplace 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. EPA’s implementation of the NMSP gives due 

consideration to the important roles of these agencies in evaluating and addressing the potential 

risks of nanoscale materials. In addition, EPA 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 Voluntary Schemes and Regulatory 

Programs illustrates the benefits of sharing experiences with other governments. EPA was able 

to share internationally the information available through its NPPTAC overview document, peer 

consultations and other experiences in developing the NMSP. EPA has also learned from the 

experience of other countries in developing and implementing voluntary reporting programs of 

the necessity for confidentiality, outreach, and deadlines to make such programs more successful. 

EPA has also exchanged information with other governments regarding application of 

regulations to nanoscale materials. 

 

 Other countries’ national chemical programs have also begun to address nanoscale 

materials. For example, the United Kingdom’s Department of Environment, Food, and Rural 

Affairs established a voluntary reporting program similar to the NMSP in September 2006. To 

date they have received 11 submissions – 9 from industry, 2 from academia8

. Australia has 

published a voluntary call for information regarding the volumes, types and data holdings of 

nanoscale materials that are being used within Australia as industrial chemicals in the 2008 

calendar year. The voluntary call for information is directed to industry and researchers. Canada 

is developing a mandatory information gathering survey for nanoscale materials under the 

authority of the Canadian Environmental Protection Act of 1999. The European Commission 

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

 

8

 Defra, 2008. “The UK Voluntary Reporting Scheme for Engineered Nanoscale materials: 

Seventh Quarterly Update.” Accessed on December 12, 2008 at: 

http://defra.gov.uk/environment/nanotech/pdf/vrs-sevetnh-progress-report.pdf. 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

Authorization and Restriction of Chemicals) legislation and will consider if there is a need for 

specific REACH regulations as they pertain to nanoscale materials. 

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Nanoscale Materials Stewardship Program 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 stronger 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 expects to receive additional submissions from companies that have 

committed to participate. Midway through the 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.) the 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 elaboration 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 notices or pre-manufacture notices under 

TSCA for their carbon nanotubes and fullerenes; and 

o policy issues relating to possible approaches and strategies for effectively 

structuring any needed regulatory requirements. 

• The NMSP has better informed the US Government’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 nanoscale 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 nanotubes and carbon nanoparticles; and 

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Nanoscale Materials Stewardship Program 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 risks to health and the environment. 

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

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

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

• It appears that approximately 90% of the different nanoscale materials that are likely to 

be commercially available were not 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 reveal 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 contain exposure or hazard-related data. 

Exposure and hazard data are two of the major categories of information EPA identified 

in its concept paper for the NMSP that are needed to inform risk assessment and risk 

management of nanoscale materials. 

• The low rate of engagement in the In-Depth Program suggests that most companies are 

not inclined to voluntarily test their nanoscale materials. 

• The need for additional progress towards addressing 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 effectiveness of existing risk management 

practices; and 

o Developing additional lessons and conclusions 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 may be needed to address nanoscale 

materials; and 

o What further risk management practices are appropriate for nanoscale 

substances? 

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Nanoscale Materials Stewardship Program 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 materials manufacturers and importers 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-Depth 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 development of the In-Depth program. 

 EPA will continue to evaluate the Basic Program submissions, including information on 

risk management practices, to identify characteristics of nanoscale materials that should be 

considered in risk assessment as well as approaches for risk management. EPA will continue 

developing the comparison of commercially-relevant nanoscale materials and refining categories 

of nanoscale materials based on molecular identity and physical properties in order to better 

understand their behavior and help prioritize research and regulatory efforts. The Agency will 

ultimately incorporate this information into its new and existing chemical review process. 

 EPA will consider how to best apply regulatory approaches under TSCA section 8(a) to 

address the data gaps on existing chemical nanoscale 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 environmental, health, and safety data. Such 

rulemaking would give due consideration 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 next steps for the NMSP as experience 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 identified 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 interim report, and will use those comments, as 

appropriate, in further refining the NMSP and in the development of the final NMSP report. 

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Nanoscale Materials Stewardship Program 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 supporting research to understand 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 written this document with three main purposes: 

(1) to guide its own researchers and managers as they conduct EPA’s research program, (2) to 

assist scientists in other organizations 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 risk assessment and risk management needs for 

nanomaterials in support of the various environmental 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 products under the leadership of its 

federal research partners in other research areas. Collaboration is encouraged among researchers 

across the government, industry, and the international 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 information for nanomaterial decision support. 

However, because other entities also conduct research related to nanomaterials and the 

environment, EPA is focusing 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 effects to inform risk assessments and test 

methods 

 Developing risk assessment approaches 

 Preventing and mitigating risks 

EPA believes that its research should advance two key objectives: (1) the development of 

approaches for identifying and addressing any hazardous properties, while maintaining beneficial 

properties, before a nanomaterial enters the environment; and (2) identifying 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 environmental impacts 

may occur, and where benefits may be attained, 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 manufactured nanomaterials: singlewalled carbon nanotubes, multi-walled carbon nanotubes, fullerenes, cerium oxide, silver, 

titanium dioxide, zero-valent iron. Ultimately, ORD has as a goal the development of predictive 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

models and tools that will enable testing across 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 testing in the OECD’s Working Party on Manufactured 

Nanomaterials. Over time, ORD expects to extend 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 protect human health and the environment? 

 Is the research important to support EPA regulatory decisions on nanomaterials? 

 What is the role EPA played in leading/coordinating this research topic under the NNI EHS 

strategy (2008)? 

 Is the research part of an international agreement to collaborate and leverage research 

activities? 

 What research themes are important to support 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 focused 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 environmental media and biological samples? 

• What are the major processes and/or properties that govern the environmental fate, 

transport, and transformation of manufactured nanomaterials, and how are these related 

to the physical and chemical properties 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 nanomaterials and their applications on human 

health, and how can these effects be best quantified and predicted? 

• What are the effects of manufactured nanomaterials and their applications on ecological 

receptors, and how can these effects be best quantified and predicted? 

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Nanoscale Materials Stewardship Program 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 high potential for release from a life-cycle 

perspective and what practices can be applied to minimize the risks of nanomaterials 

throughout their life cycle? 

• How can manufactured nanomaterials be applied for treatment and remediation of 

contaminants, and what decision-making methods 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 research multi-year plans present the long-term 

strategic vision of the EPA’s research programs. The MYPs serve as a planning and 

communication tool to describe the scope of research addressing 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 information to aid in and support 

decisions during budget formulation; and (3) assist in managing performance and accountability 

reporting, including the OMB Program Assessment Rating Tool (PART) review. 

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Nanoscale Materials Stewardship Program 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 addressing human health and environmental safety 

aspects of manufactured nanomaterials. The Chemicals Committee also established a Working 

Party on Manufactured Nanomaterials (WPMN) to implement its Program of Work. The 

objective of the WPMN is to promote international cooperation in human health and 

environmental safety related aspects 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 Representative Set of Manufactured Nanomaterials; 

 • Manufactured Nanomaterials and Test Guidelines; 

 • Cooperation on Voluntary Schemes and Regulatory Programs; 

 • Cooperation on Risk Assessment; 

 • The Role of Alternative Methods in Nanotoxicology; and 

 • Exposure Measurement and Exposure Mitigation 

 

These eight projects are being managed by eight steering groups which are implementing 

their “operational plans”, each with their specific objectives and timelines. These steering 

groups (which average around 20 participants) are being led/ chaired by members of the WPMN, 

with support from the OECD Secretariat. Much of the work has been (and is being) undertaken 

through teleconferences and electronic means. At the same time, 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 and endorsed by the entire WPMN. 

 

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Nanoscale Materials Stewardship Program 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 terephthalate) 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 

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Nanoscale Materials Stewardship Program 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 carbon nanotubes (SWCNT) 

 gold nanochain (AuNP) 

 AuNP embedded 

 sticky gold nanoparticles 

 sugar-coated gold nanoparticles (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 citrates, (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-octylammonium chloride colloid 

 rhodium/tetra-n-octylammonium chloride 

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Nanoscale Materials Stewardship Program 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-rhutenium/tetra-n-octylammonium 

chloride colloid 

 rhodium colloid (polyethyleneglycoldodecylether, hydrosol) 

 iron-cobalt nanoparticles (surfaced modified 

with L-cysteine ethyl ester)(wet with ethanol) 

 platinum-ruthenium colloid 

(polyethyleneglycol-dodecylether,hydrosol) 

 nickel/tetra-n-octylammonium 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 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

13 Annex  D ‐ OECD Sponsorship Program for the Testing of

Manufactured Nanomaterials (MN)

Current Sponsors (as of 13 October 2008i)

Representative 

Set of MNii Lead sponsor(s)iii Co-sponsor(s)iv Contributorsv

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 

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Nanoscale Materials Stewardship Program Interim Report January 2009 

37

Representative 

Set of MNvi Lead sponsor(s)vii Co-sponsor(s)viii Contributorsix

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 Program 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.