Meeting Summary Report

Nanoscale Materials Stewardship Program

(August 2, 2007 Meeting)

Prepared for:

U.S. Environmental Protection Agency

Office of Prevention, Pesticides and Toxic Substances

1200 Pennsylvania Avenue, NW

Washington, D.C. 20460

Prepared by:

Eastern Research Group, Inc.

14555 Avion Parkway 

Suite 200

Chantilly, VA 20151-1102

August 8, 2007

EPA Contract No. EP-W-05-014

Work Assignment 3-0TABLE OF CONTENTS

Page

  TOC \o "1-3" \h \z    HYPERLINK \l "_Toc174363150"  1.0	Introduction	 
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  HYPERLINK \l "_Toc174363151"  1.1	Background and Purpose	  PAGEREF
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  HYPERLINK \l "_Toc174363152"  1.2	Key Questions	  PAGEREF
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  HYPERLINK \l "_Toc174363153"  2.0	Remarks and Comments	  PAGEREF
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  HYPERLINK \l "_Toc174363154"  2.1	Introductory Remarks	  PAGEREF
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  HYPERLINK \l "_Toc174363155"  2.2	Public Comments from Registered
Speakers	  PAGEREF _Toc174363155 \h  2-2  

  HYPERLINK \l "_Toc174363156"  2.2.1	Dr. Shaun Clancy of Degussa
Corporation on behalf of the American Chemistry Council	  PAGEREF
_Toc174363156 \h  2-2  

  HYPERLINK \l "_Toc174363157"  2.2.2	Dr. Richard Denison, Environmental
Defense	  PAGEREF _Toc174363157 \h  2-4  

  HYPERLINK \l "_Toc174363158"  2.2.3	Bernard Made, Environment Canada	 
PAGEREF _Toc174363158 \h  2-6  

  HYPERLINK \l "_Toc174363159"  2.2.4	Carolyn Nunley Cairns, Consumers
Union	  PAGEREF _Toc174363159 \h  2-7  

  HYPERLINK \l "_Toc174363160"  2.2.5	Scott Slaughter, the Center for
Regulatory Effectiveness	  PAGEREF _Toc174363160 \h  2-8  

  HYPERLINK \l "_Toc174363161"  2.2.6	Terry Davies, Woodrow Wilson
Center	  PAGEREF _Toc174363161 \h  2-9  

  HYPERLINK \l "_Toc174363162"  2.2.7	James Cooper, Synthetic Organic
Chemical Manufacturers Association	  PAGEREF _Toc174363162 \h  2-10  

  HYPERLINK \l "_Toc174363163"  2.2.8	Igor Linkov, Intertox, Inc.	 
PAGEREF _Toc174363163 \h  2-12  

  HYPERLINK \l "_Toc174363164"  2.2.9	Kristin Kulinowski, International
Council on Nanotechnology, Rice University	  PAGEREF _Toc174363164 \h 
2-12  

  HYPERLINK \l "_Toc174363165"  2.2.10	Sean Murdock, NanoBusiness
Alliance	  PAGEREF _Toc174363165 \h  2-13  

  HYPERLINK \l "_Toc174363166"  3.0	Question and Answer Session for Key
Issues	  PAGEREF _Toc174363166 \h  3-1  

  HYPERLINK \l "_Toc174363167"  3.1	General Questions and Answers	 
PAGEREF _Toc174363167 \h  3-1  

  HYPERLINK \l "_Toc174363168"  3.2	Key Questions and Answers	  PAGEREF
_Toc174363168 \h  3-2  

 

Appendix A:	MEETING AGENDA

Appendix B:	LIST OF OBSERVERS

Introduction

	This report summarizes remarks and public comments made during the
public meeting on the voluntary Nanoscale Materials Stewardship Program
(NMSP) organized by the U.S. Environmental Protection Agency (EPA). The
meeting was announced in a Federal Register notice (72 FR 38081, 12 July
2007) and took place in Arlington, Va. on August 2, 2007 at the Holiday
Inn Rosslyn at Key Bridge. 

	The meeting agenda was structured to allow formal comments from eight,
pre-registered stakeholders. Time in the afternoon was also allocated to
allow additional stakeholders who requested time to speak to make public
comments. An opportunity to make any additional comments or ask
questions was provided.  The meeting concluded with a question and
answer session focusing on key issues that were specifically identified
by EPA in the Federal Register notice.  Appendix A contains a copy of
the meeting agenda.

	 The meeting brought together 124 participants, including stakeholders
in academia, non-governmental organizations (NGOs), government,
industry, professional organizations, the press, international entities,
and the general public.  Appendix B presents the final list of
observers.

	Eastern Research Group, Inc. (ERG), a contractor to EPA, provided
logistical support and prepared this summary report.  Meeting minutes
were not prepared and a transcript was not recorded.  The intent of this
report is to provide an overview of the discussion that occurred.  No
attempt has been made to analyze or evaluate any portion of the
discussions.  The discussion and comments presented in this summary
reflect individual opinions of the commenters and should not be
considered to be the opinion or belief of EPA.  Formal, written comments
that are received per instructions in the Federal Register notice will
be incorporated into the public docket. 

Background and Purpose

	In two separate Federal Register notices, EPA announced the
availability of the “Concept Paper for the Nanoscale Materials
Stewardship Program under TSCA” and the “TSCA Inventory Status of
Nanoscale Substances - General Approach” (72 FR 38083, 12 July 2007)
and the proposed Information Collection Request’s supporting statement
and draft reporting form  (72 FR 38079, 12 July 2007). The purpose of
the meeting was to discuss and receive comments on the development of
the voluntary NMSP, including comments on the associated program
documents referenced above. 

Key Questions

	EPA outlined several key questions for stakeholders’ consideration. 
These questions were intended to form the basis of discussion for this
meeting.  EPA specifically asked for input from participants on each
question after conclusion of the comment presentations. The discussion
is summarized in Section 3.0 of this document.  Specifically, EPA
(through the FR notice) asked stakeholders to comment on:

Whether the data elements that have been identified in the NMSP are
appropriate for nanoscale materials;

 

The timing and phasing of submissions under the NMSP basic and in-depth
programs and whether approaches for tiering data submissions are
appropriate; 

Who would participate in the NMSP and how to encourage participation,
especially from small and medium sized enterprises; 

What criteria to use for NMSP program evaluation and views on the timing
and nature of any reports the Agency may issue;  

How to engage industry and other stakeholders in the NMSP in-depth
program and approaches for generating test data; 

The processes and roles for EPA, participants, and other stakeholders
during development and evaluation of data for the in-depth program; 

Possible approaches for identification and use of alternative sources of
data, in order to minimize the burden of information collection
associated with the NMSP; 

Uses for the data submitted to EPA under the NMSP program;  

Issues relevant to scope, definitions and descriptions; 

The suitability of the approach for determining the TSCA Inventory
status of nanoscale materials discussed in the Inventory paper; and

Whether, in combination, the TSCA Inventory paper and the NMSP concept
paper are sufficiently clear in how EPA plans at this time to address
nanoscale materials that are new or existing chemicals under TSCA and
the NMSP. Remarks and Comments

Introductory Remarks

	Jim Willis (Director, Chemical Control Division, Office of Pollution
Prevention and Toxics, EPA) greeted meeting participants and provided an
overview of logistics for the meeting. He also reminded participants
that comments must be submitted to the Docket by September 10, 2007.  

	Jim Gulliford (Assistant Administrator, Office of Prevention,
Pesticides, and Toxic Substances, EPA) provided keynote remarks. Mr.
Gulliford thanked participants in advance for their input and noted that
stakeholder input is an integral piece of the process for developing a
voluntary program. Mr. Guilliford acknowledged that the use of nanoscale
materials is an exciting field with many potential benefits, but
recognized that, as a new technology, the proper regulatory oversight is
required to ensure responsible and safe development of nanoscale
chemicals and applications under the Toxic Substances Control Act or
TSCA.

	Mr. Guilliford commented that EPA is working with other federal
agencies engaged in research, development, and regulation to ensure
adequate oversight of nanoscale materials. Mr. Gulliford emphasized that
the Nanoscale Materials Stewardship Program is not a regulatory program
or framework – it is a tool to inform EPA’s overall approach to
address nanoscale materials.

	Charlie Auer (Director, Office of Pollution Prevention and Toxics, EPA)
discussed the purpose of the meeting and provided a brief overview of
the NMSP.  Mr. Auer reiterated that the NMSP is one component of an
overall approach for EPA to address nanoscale materials.  Further, he
stated that EPA has taken several actions over the last several years to
address the oversight of nanoscale materials, including:

Holding an initial meeting in June 2005 on the Toxic Substances Control
Act (TSCA) and Nanotechnology.

Working with the National Pollution Prevention and Toxics Advisory
Committee (NPPTAC), which produced an Overview Document for EPA’s
consideration in November 2005.  The NPPTAC Overview Document identified
issues related to development of a stewardship program for nanoscale
materials under TSCA, and EPA has drawn from many of the NPPTAC concepts
presented in the document. 

In October 2006, EPA launched a collaborative process to design a
Nanoscale Materials Stewardship Program under TSCA to complement and
support its efforts on new and existing chemical nanoscale materials. As
part of this process, EPA developed draft documents pertaining to the
design of the NMSP which were published in the Federal Register on July
12, 2007, including:

A Concept Paper for the Nanoscale Materials Stewardship Program, 

TSCA Inventory Status of Nanoscale Materials - General Approach, and

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

	Mr. Auer then provided an overview of each of these documents.

	After completing the document summary, Mr. Auer then explained that EPA
anticipates three phases for the NMSP.  Phase 1 is the design phase and
is ongoing.  The second phase is the implementation stage where data on
nanoscale materials would be gathered by participants and submitted to
EPA.  The final phase is the evaluation phase, where EPA will assess
progress, review any additional information collected to inform the
evaluation, and determine the future direction of the program.  

	Mr. Auer stated that EPA intends to develop the details of the NMSP
based on input from this public meeting, written public comments in
response to the Federal Register Notices, input from the public
scientific peer consultation on risk management practices for nanoscale
materials held in October 2006, and the upcoming public scientific peer
consultation on material characterization for nanoscale materials, which
will be held September 6-7, 2007. 

	Mr. Auer encouraged industry and other stakeholders to actively
contribute to the design and implementation of the NMSP. He noted that
the understandings developed under the NMSP and the existing regulatory
frameworks within which EPA must work will together inform EPA of the
most appropriate next steps.

	Mr. Auer reminded participants that EPA will be sponsoring a conference
on pollution prevention through nanotechnology.  The conference will be
held on September 25-26, 2007. A primary purpose of the P2 conference is
to exchange information and ideas on the potential environmental and
pollution prevention benefits of innovative nanotechnologies and
nanomaterials.  A second area of concentration is to identify and
promote stewardship opportunities associated with applications of
nanotechnology

Public Comments from Registered Speakers

	Jim Willis initiated the public comment period by inviting registered
speakers to present their comments, which was then followed by questions
of clarification from the audience. Mr. Willis encouraged speakers to
formally submit their statements as written comments to the Docket.

Dr. Shaun Clancy of Degussa Corporation on behalf of the American
Chemistry Council

	Dr. Clancy presented comments on behalf of the Nanotechnology Panel of
the American Chemistry Council (ACC). Specific points made include:

The Nanotechnology Panel believes that EPA has done a commendable job in
developing the NMSP given the diversity of viewpoints;

The Nanotechnology Panel supports the basic elements of the NMSP and the
inclusion of both a basic and in-depth program, and believes doing so is
an excellent way to encourage participation by those who may have
limited data and/or information and/or may not have the resources needed
to support development of new data;

EPA and others should recognize that the use of nanomaterials may not be
as widespread as some may have suggested;

The Nanotechnology Panel urged EPA and others to measure the success of
the program in terms of the value of the information submitted and its
utility in assisting EPA in developing a firmer foundation for
scientific, regulatory, and policy decision-making;

Dr. Clancy noted that the Nanotechnology Panel has surveyed its members
regarding their respective risk management practices and will make the
results available to EPA and the public on the Panel’s Web site ( 
HYPERLINK "http://www.amercianchemistrycouncil.com/nanotechnology" 
http://www.amercianchemistrycouncil.com/nanotechnology ). 

The Nanotechnology Panel believes that it is important to manufacturers
of nanoscale materials that confidential business information (CBI)
remain confidential, and EPA’s ability to protect CBI will enhance the
likelihood of participation in the NMSP;

The Nanotechnology Panel urged EPA that the NMSP recognize the
importance of the need to characterize nanoscale materials;

The Nanotechnology Panel questioned whether the NMSP would be able to
determine the volume of nanoscale materials currently in use;

The Nanotechnology Panel encouraged the submission of data under the
MNSP for materials that are not explicitly included in the NMSP but may
be thought to be nanoscale materials as it may provide a better, more
reliable indication of the volumes of materials in commerce that are
thought to be nanoscale, but actually may not be nanoscale;

The Nanotechnology Panel noted that the NMSP does not address timing for
submitting and reviewing information;

The Nanotechnology Panel urged EPA to consider allowing participants of
the basic program to submit data and information for a period of nine
months after the NMSP formally begins;

The Nanotechnology Panel urged EPA to consider allowing participants of
the in-depth program to submit data and information for a period of two
years after the NMSP formally begins, but also allow the timeframe to be
flexible given uncertainties; and

Lastly, the Nanotechnology Panel urged EPA to consider identifying a
target date to conduct an interim evaluation of the NMSP and a date for
final evaluation of the NMSP.

	EPA asked why the Panel recommended nine months for the basic program. 
Dr. Clancy explained that the Panel sought a need to impose a deadline
to speed the program along.

Dr. Richard Denison, Environmental Defense

	Dr. Denison presented comments on behalf of Environmental Defense.
Specific points made include:

Environmental Defense initially supported the proposal for a voluntary
program under the premises that EPA would expeditiously enact a program
that would quickly inform EPA and the public as to which nanoscale
materials were in or soon to enter commerce and the extent of
risk-relevant information that was available;

Environmental Defense was disappointed that EPA is only now presenting
the concept for the voluntary program, and was concerned that EPA has
excluded key elements from the National Pollution Prevention and Toxics
Advisory Committee (NPPTAC) recommendations, specifically the lack of
deadlines and no regulatory backstop;

Environmental Defense concluded that it was unable to support EPA’s
proposal for a voluntary basic program given the delay, absence of
deadlines, and absence of a regulatory backstop;

Environmental Defense mentioned similar programs in the United Kingdom 
(UK) and Denmark and noted their poor rates of participation due to (in
the opinion of Environmental Defense) the lack of such key elements;

Environmental Defense noted that the Organization for Economic
Cooperation and Development (OECD) has recently discussed how
governments can make it easier for companies to participate in voluntary
programs;

Environmental Defense expressed concern over potential measures to
increase participation discussed at the OECD, including: greater
allowances for CBI claims, limiting the ways in which governments would
use information submitted, and allowing data to be submitted in any form
and format;

Environmental Defense feels that the U.S. and other OECD members are
losing sight of a key objective – to build public trust and confidence
by making robust information available;

Environmental Defense was concerned that there is significant potential
for participation in a voluntary program to be both limited and
selective which may result in a highly skewed picture regarding the
range of nanoscale materials in or soon to be in commerce;

Environmental Defense urged EPA to rapidly develop and implement
mandatory reporting rules;

Environmental Defense believes that mandatory reporting rules are the
only viable means to ensure a level playing field and submission of a
comprehensive and representative set of information;

If EPA chooses to proceed with the voluntary program, Environmental
Defense suggests that data be submitted under the basic program within
three months while concurrently pursuing the use of reporting rules;

With respect to the in-depth program, Environmental Defense observed
that EPA’s proposal does not address how its proposal relates to the
OECD’s Working Party of Manufactured Nanomaterials (WPMN) efforts to
undertake in-depth hazard data development for representative nanoscale
materials;

Environmental Defense noted that EPA’s resources and efforts would be
better spent in ensuring that the WPMN initiative is as robust and
executed as expeditiously as possible.  Environmental Defense also
stated that this work should focus on monitoring, estimating exposures,
and personal protective equipment for nanoscale materials and urged
working with NIOSH in this area immediately;

Environmental Defense disagreed with EPA’s proposed approach to
determining the TSCA Inventory status of a nanoscale material;

Environmental Defense believes that EPA’s approach does not need to be
based on precedent (i.e., EPA could use particle size to distinguish
among substances on the Inventory even though it has not done so in the
past). 

Environmental Defense also believes the approach reflects bad policy
because it suggests that nanoscale materials are nothing new; thereby,
eliminating any possibility of pre-market review through the New
Chemical’s Program;

Environmental Defense highlighted their concerns regarding the use of
Significant New Use Rules (SNURs) and noted that EPA will have serious
challenges to overcome if EPA proposes the use of existing chemical
SNURs as a means to ensure that engineered nanoscale materials are
effectively assessed prior to commercial introduction; and

Environmental Defense concluded that EPA’s documents fail to
acknowledge and consider the implications of the proposed approach with
respect to EPA’s ability both to carry out its responsibility to
ensure that engineered nanoscale materials do not pose undue risk to
human health or the environment, and to keep up with the
ever-accelerating pace of technology and new materials development.

Bernard Made, Environment Canada

	Mr. Made provided an overview of Canada’s perspective.  Specific
points made 	include:

The NMSP needs to be properly framed in term of risk assessment and risk
management;

The NMSP needs to be considered within existing legal and regulatory
contexts; 

Mr. Made explained that Canada has analogous programs that establish
information requirements, and Canada maintains a Domestics Substances
List that is very similar to the TSCA Inventory;

Mr. Made noted that Canada would like to address nanomaterials as new
chemicals based on properties that result in new effects;

He indicated however that based on existing Canadian law some
nanomaterials would be considered new and others would be considered
existing, and that the distinction would be based on chemical structure;

Canada encourages companies to contact regulatory authorities for
assistance in making the determination;

Environment Canada will be holding a meeting on September 27, 2007 in
Toronto to discuss similar issues, and plans to release a proposed
approach and discussion paper;

Environment Canada published an advisory that explained two proposed
phases of a program similar to the NMSP:

Phase 1 would describe regulatory issues and implications and would
consist of an information gathering initiative to identify who, what,
how much, how used, what is in commerce, and whether existing data
exist.  Mr. Made noted that it would be important to establish a
baseline to inform future decisions and recognize if issues currently
exist.

Phase 2 is expected to occur in mid-2008 and will address nomenclature
issues, develop specific requirements, and consider significant new
activity provisions of the Act for existing chemicals that will require
additional data to be submitted.

As part of a standard 5 year review, Canada’s Parliament is
considering modifying the Canadian Environmental Protection Act (CEPA);

This is a parliamentary review so, it is unclear whether or not
parliamentarians will consider changes to CEPA to establish special
provisions for nanomaterials;

Lastly, Mr. Made stressed the importance of international cooperation:

Agencies can benefit from international cooperation,

Environment Canada hopes that a similar approach between the U.S. and
Canada can be developed,

Mr. Made mentioned that Canada is also involved with the OECD working
group and the International Organization for Standardization, and

Environment Canada looks forward to information sharing.

Several questions of clarification were posed:

Mr. Made confirmed that the legal framework within which Canada is
working is similar to the U.S. and that Environment Canada will consider
the appropriateness of characterizing nanomaterials as new chemicals in
the future."

Mr. Made confirmed that the information gathering effort will begin in
2008.  Whether the effort will be voluntary versus mandatory has not
been determined and will be a subject of the September meeting.  He
noted that a combined approach could be an option where some data are
mandatory while other data could be voluntarily submitted.

Mr. Auer thanked Mr. Made for Environment Canada’s comments and
reiterated that EPA is continuing to work very closely with Environment
Canada and Health Canada.

Carolyn Nunley Cairns, Consumers Union

	Ms. Cairns presented comments on behalf of Consumers Union. Specific
points made include:

EPA should ensure materials are safe prior to introducing them into
commerce; 

A voluntary program is not sufficient given the potential risks;

If a voluntary program is undertaken, EPA should ensure that a thorough
substantiation of the submitted information occurs;

Public access to information is critical;

EPA must actively manage nanomaterials as new chemicals or as existing
chemicals with significant new uses;

Consumers Union is concerned that past lessons-learned are not being
considered (e.g., Ms. Cairns alluded to past history regarding the uses
of lead and mercury) – she argued that scientific understanding should
precede consumer exposure to ensure that unidentified risks do not
surface in the future. Ms. Cairns urged EPA to deal with nanotechnology
differently to better anticipate risk and manage risks prior to entry
into commerce;

Consumers Union noted that the primary shortcomings of EPA’s proposal
are its voluntary nature and the potential for inadequate participation;

Consumers Union commented that, given the current proposal, it was
difficult to see how the NMSP could expedite EPA’s and the public’s
understanding of nanomaterials;

Consumers Union urged EPA to conduct mandatory pre-market assessments
that, at a minimum, are conducted in parallel with the NMSP to ensure
that consumers are not subjected to materials prior to EPA assessing
risks;

Consumers Union expressed concern over the lack of a reporting schedule;

Consumers Union stressed the importance of ensuring publicly available
information in a standardized format;

Consumers Union suggested a two-track program whereby EPA could quickly
get a sense of the current state while planning for detailed information
requirements;

Ms. Cairns noted that a recent investigation shows a wide-range of
public opinions regarding risks and safety exists;

Consumers Union reiterated that lack of evidence of harm is not an
assurance of safety;

Consumers Union is concerned that EPA appears to be ignoring the science
that indicates nanomaterials are different enough that they should be
considered new chemicals and EPA should also issue SNURs; and

Consumers Union urged EPA to accelerate the regulatory process.

	EPA reminded participants to read the information contained in the
annexes of the documents.  EPA requested that stakeholders comment on
certain aspects that are presented in the annexes and specify whether
content should be more prominently presented.

	EPA indicated that it will consider Environmental Defense’s position
as comments and will consider them as the program is finalized.  EPA
noted that the proposed basic program was to span two years; however,
the American Chemistry Council suggests nine months and Environmental
Defense suggests three months followed by evaluation.  EPA may consider
a compromise between both suggestions if it is possible to accommodate a
shorter duration.  EPA noted that the basic program has to be completed
prior to moving forward and the quicker the better.

Scott Slaughter, the Center for Regulatory Effectiveness

	Scott Slaughter presented comments on behalf of the Center for
Regulatory Effectiveness. Specific points made include:

Mr. Slaughter encouraged voluntary submission of data, and encouraged
EPA to make the data publicly available when possible;

Mr. Slaughter stressed that data must meet data quality standards in
order to allow EPA to use the data, and he questioned how the data would
be reviewed and be determined to be in compliance with quality
requirements for use of data;

 

Mr. Slaughter encouraged EPA to establish a system for screening data
for compliance and require submitters to initially self-screen;

The Center for Regulatory Effectiveness is concerned that the Office of
Management and Budget will not approve the ICR without addressing such
issues;

Mr. Slaughter questioned whether the upcoming peer consultation on
materials characterization would address data quality.  [Mr. Auer
responded to this inquiry by noting that EPA wants any data regardless
of whether it is “scrubbed.”  He described EPA’s standard method
for assessing data quality and indicated the same process would be
utilized for the NMSP.  This process is based on the approach used when
assessing new chemicals which requires that all information be
submitted, some of which meets good laboratory practice (GLP) standards
and OECD test guidelines. EPA assesses the quality of information
submitted and may require further GLP testing if necessary.]

After listening to Mr. Auer’s response to his question, Mr. Slaughter
suggested that EPA provide a similar explanation, within the context of
data submitted for nanomaterials, in the supporting statement of the
ICR;

Terry Davies, Woodrow Wilson Center

	Terry Davies presented comments on behalf of the Project on Emerging
Nanotechnologies of the Woodrow Wilson International Center for
Scholars. Specific points made include:

Mr. Davies reminded meeting participants of the latest report issued by
the center: “EPA and Nanotechnology: Oversight for the 21st Century”
that was published in May [available at:
http://www.wilsoncenter.org/nano];

Mr. Davies agreed that the NMSP is potentially useful and that it makes
sense to have a program to inform the current state of nanotechnology so
long as it does not delay putting an adequate oversight system in place;
 

Mr. Davies urged EPA to feel a sense of urgency to get a handle on the
current state of these materials, as it is estimated that nanomaterials
are introduced in products at a rate of five products/week;

 

Mr. Davies was disappointed in the delay of initiating the NMSP and
encouraged EPA to “just do it and quickly” regarding establishment
of deadlines for implementing the program, receiving submissions, and
ultimately ending the voluntary program;

Mr. Davies raised concerns over his expected level of participation in
the NMSP and noted that incentives are lacking;

 

Mr. Davies is concerned about the definition of “chemical substance”
presented in the TSCA Inventory paper.  He stated that in his view, the
Agency is binding itself to the current definition, and that rather than
recognizing the issues associated with the definition, EPA should
consider whether changes are warranted;

Mr. Davies commented that the proposed policy ignores the important
distinction that size makes a difference;

 

Mr. Davies outlined several steps that he believes EPA should take,
including:

Initiate a regulatory program in tandem with the NMSP to gain a double
benefit of not delaying regulatory oversight and encouraging
participation,

EPA should consider the past success of the 33-50 program and consider
using it as a model,

EPA should recognize that the keystone to the regulatory effort should
be a SNUR applied to all nanomaterials,

EPA should consider utilizing TSCA 8(a) as a supplement or potential
substitute for a SNUR(s), and

The Inventory Paper needs to be revised to reflect that nanomaterials
are not the same, in terms of biological or ecological characteristics,
as the same material in the macroscopic scale.

James Cooper, Synthetic Organic Chemical Manufacturers Association

	James Cooper presented comments on behalf of the Synthetic Organic
Chemical Manufacturers Association (SOCMA). Specific points made
include:

Mr. Cooper explained that SOCMA’s position is that fine particulates
are not new chemicals, and that very few chemistries exist at the
nanoscale;

SOCMA noted that few products contain ingredients that are at the
nanoscale;

SOCMA also commented that no universal consensus on toxicity of
nanomaterials as a whole exists and SOCMA recognizes that the unique
properties warrant further research and consideration;

SOCMA commented that many materials are currently being studied and the
NMSP will facilitate quicker access to available information (noting
that journals do not typically publish negative studies but the NMSP
will gather this information);

Mr. Cooper noted that he was a member of the NPPTAC sub committee.  He
stated that within the NPPTAC there was no consensus regarding
development of a regulatory component, except as a regulatory backstop,
but there was agreement that something would be helpful – exactly what
was unclear;

Mr. Cooper noted that there was some agreement within NPPTAC that if
both a voluntary and regulatory program were run in parallel that would
be a disincentive for a voluntary program and small companies may only
focus on the regulatory requirements rather than participate in a
voluntary program;

SOCMA mentioned the High Production Volume Challenge Program and
commented that EPA should review lessons-learned when implementing it. 
For example, EPA should recognize the importance of flexibility in
timing (i.e., recognize that issues can arise with testing that must be
overcome, that developing consortia takes time);

SOCMA commented that the measure of the success of the program should be
the number of substances sponsored not the number of companies.

SOCMA reiterated the importance of handling CBI, noted that protection
of CBI is critical to ensure success and adequate participation, and
that CBI is the only way a small company has a competitive advantage
particularly for new uses;

 

SOCMA agreed that the data elements presented by EPA are sufficient 

SOCMA encouraged tiered participation whereby smaller firms would be
less intimidated.

SOCMA commented that the TSCA Inventory is a molecular-based list and
that changing the basis for the Inventory would require significant
review and modification of nomenclature issues;

SOCMA encouraged stakeholders to give the NMSP a chance to work before
instituting regulations;

SOCMA noted that public recognition of NMSP participation is a very
important incentive;

SOCMA was supportive of EPA’s suggestion to hold workshops to educate
smaller entities about TSCA and the NMSP which is also an incentive to
participation;

SOCMA emphasized the importance of coordination with other federal
agencies and the international community, especially with OECD;

SOCMA commented that a key item related to information collection and
the subsequent evaluation would be to focus on information that will
allow trends assessment and facilitate predications based on these
trends;

SOCMA questioned the need for a broad SNUR if the NMSP is effective and
suggested promulgating tailored SNURs, when necessary; and

Lastly, SOCMA commented that if a regulatory component is developed, EPA
should ensure that a level playing field exists among potentially
affected entities.

Igor Linkov, Intertox, Inc.

	Igor Linkov, Intertox, Inc. gave a presentation titled,
“Multi-Criteria Decision Analysis and Nanomaterials Risk
Management.”  EPA suggested that Mr. Linkov consider submitting the
presentation to the Docket as comments, and Mr. Linkov indicated he
would do so.

	Mr. Linkov’s presentation conveyed three primary points:

The relation of pattern, structure-activity and physico-chemical
properties of nanoparticles on toxicity and life-cycle risk is widely
unknown and available information is fragmented.

EPA View: Challenges of risk assessment and management for situations
with a limited knowledge base and high uncertainty and variability
require coupling traditional risk assessment with multi-criteria
decision analysis (MCDA) and Adaptive Management to support regulatory
decision making.

Industry View: Entities engaged in nanotechnology must consider
practical and innovative steps to minimize identified risks while
managing proactively for unknowns. EPA’s stewardship program should
provide value to business by helping focus on decreasing life-cycle
product risk while keeping costs down.

	Mr. Linkov encouraged EPA to be very explicit and clear on what
information is needed and why.  He also stated that EPA should covey how
the information can be beneficial to industry.  Mr. Linkov presented a
case study that demonstrated how such information could be used to
inform waste management decisions.

Kristin Kulinowski, International Council on Nanotechnology, Rice
University

	Dr. Kulinowski presented comments on behalf of the International
Council on Nanotechnology (ICON). Specific points made include:

Dr. Kulinowski indicated that ICON had engaged in considerable
discussion regarding merits of the NMSP; however, ICON is not taking an
formal position on the proposed program;

Dr. Kulinowski indicated that ICON is united in efforts to develop a
better understanding of interactions among nanomaterials and
environmental health and safety;

Specifically, ICON encouraged EPA to take action to:

Develop a publicly-accessible database of information gathered (e.g.,
physical/chemical data, and data on biological and environmental
interactions) to facilitate advancement of basic knowledge,

Make as much effort as practical to present the data in the public
domain, recognizing the importance of protecting CBI,

Structure data collection requests to conform to data standards and
published consensus standards (e.g., ASTM, ISO) and encourage
participants to use common submission formats, and

Continue to gather data on as many nanomaterials as possible.

Dr. Kulinowski’s stated that ICON’s comments should not be
interpreted as support for rigorous regulations;

ICON is currently working to develop a needs assessment to evaluate what
is known and the corresponding environmental and health and safety
implications; and to direct resources toward gaps to facilitate
obtaining information to better predict biological and environmental
interactions.  The goal of the project is the design of benign nanoscale
materials and safe applications and the project is relevant to the data
elements in the NMSP;

ICON is developing a framework that will enable prediction of the
interactions of nanomaterials;

The summaries of two workshops that were held on these topics will be
released in the fall. These summaries will highlight what
characteristics were viewed as important by participants; and

ICON looks forward to participating in the upcoming peer consultation on
materials characterization.

Sean Murdock, NanoBusiness Alliance

	Sean Murdock presented comments on behalf of NanoBusiness Alliance.
Specific points made include:

Mr. Murdock noted that the NanoBusiness Alliance has been a long-time
supporter of the concept of the NMSP and commended EPA on the overall
program design;

NanoBusiness Alliance noted that it is critical that the NMSP create
minimal burden on small companies, and that since the basic program does
not require an organization to generate new data, it will encourage
participation by small companies who have launched products;

NanoBusiness Alliance cautioned EPA that recent media coverage may
overestimate the market penetration and use of nanomaterials. 
NanoBusiness Alliance stated only a select few companies in the
NanoBusiness Alliance are actually producing nanomaterials at the
commercial scale;

The NanoBusiness Alliance stated that the number of small companies is
less than the ICR estimates because most companies are at the product
development stage;

The NanoBusiness Alliance believes that robust characterization of
nanomaterials is fundamental to the success of the in-depth program;

The NanoBusiness Alliance supports the principle of transparency and
encourages companies to place information in the public domain when
practical; and

NanoBusiness Alliance stressed the importance of protecting CBI due to
Intellectual Property considerations.

Several questions of clarification were posed:

The concept of “intended for commercial use” was discussed.  A
participant questioned how many concept products have actually launched
versus those that are in concept development.  Mr. Murdock indicated
that it is difficult to know for certain, but that many more products
are in the concept development phase. He suggested that efforts should
be focused on products that actually launch.

A participant questioned whether there was a way, such as patents, to
verify the number of products that have been commercialized.  Mr.
Murdock stated that he believes it is not possible because of the lack
of authoritative information on what exactly is in commerce.Question
and Answer Session for Key Issues

	EPA provided meeting participants with an opportunity to make any
additional comments or ask questions.  This discussion was followed by a
question and answer session focusing on key issues specifically
identified by EPA in the Federal Register notice.  A summary of these
discussions is presented below.

General Questions and Answers

	A meeting participant questioned whether the trade association
representatives had a sense of the expected level of participation among
their members.  The American Chemistry Council declined to provide a
specific number of companies that would participate, noting that
commitments would be made a company level, however ACC members are
generally supportive of the NMSP and are expected to make commitments. 
The NanoBusiness Alliance provided a similar response; indicating that
it is still premature, but they expect members will volunteer to
participate.

	One participant noted several criticisms of the NMSP that were raised
with respect to the similarities to the United Kingdom’s program and
their perceived lack of success.  He asked the audience if there is
anything EPA could do differently to ensure more successful
participation.  Sean Murdock (NanoBusiness Alliance) indicated that
there may have been a lack of motivation because no deadlines existed
and there was a perceived issue with protection of CBI in the UK, based
on past incidents.  Bill Gulledge (ACC) also noted that there is a
difference in market size; therefore, although the actual number of
participants is small, the percent of companies responding may not be.

	A participant commented that the TSCA inventory paper was helpful and
questioned whether EPA had given any further thought on use of SNURs. 
EPA responded that the paper’s annexes discuss the TSCA authorities
that address SNURs.  There are criteria established by the statute that
EPA must use to determine whether a use is a significant new use (i.e.,
understood as something that is not ongoing and is significant).  EPA
recognized that a challenge it will face if it considers a SNUR is
defining the conditions that would merit “significant new use” that
would trigger notification requirements.  EPA will need to determine how
that trigger would be defined in a general, overarching way.  EPA also
stated that it expects that experience gained through the NMSP and new
chemical program will help inform the Agency on whether a SNUR is
appropriate.

	Another participant noted that the United Kingdom allowed academic
institutions to participate in their voluntary program, where it appears
that the U.S. is restricting non-commercial applications. EPA indicated
that the program is not limited to engineered nanoscale materials
manufactured or imported for commercial purposes.  EPA referred
participants to text in the proposed NMSP paper that allows
non-commercial entities to participate and encouraged full
participation.  Another participant indicated that allowing submissions
from academic institutions was an excellent idea, stating that most
academics would like to publish test results in open literature but it
is not common to publish “negative results”.  Participation in the
NMSP would provide a venue to report negative results.  Multiple
participants suggested that EPA revise the NMSP description to clearly
state that non-commercial entities could participate.

Key Questions and Answers

	EPA outlined eleven specific key questions for stakeholders’
consideration in the Federal Register notice.  Jim Willis asked for the
meeting participants to provide verbal responses to each of these
questions, noting EPA requests written comments be submitted per
instructions in the Federal Register notice.  The questions, participant
responses, and subsequent discussions are summarized below.

Whether the data elements that have been identified in the NMSP are
appropriate for nanoscale materials; 

A participant noted that the list is comprehensive and questioned how
EPA would prioritize and use the data.  He suggested that clarifying
this may encourage participation.  He also suggested that the question
posed by EPA (whether the data elements are appropriate) cannot be
answered without knowing how the information will be used.

EPA replied that it intends to ask for information pertaining to all of
the data elements.  A subsequent evaluation of the responses will then
determine exactly how it will be used. 

EPA added that the draft data elements were developed based on EPA risk
assessors’ experience evaluating data that are requested for the PMN
review process.  EPA also stated that initially, EPA only wants
information that companies already possess.

EPA requested comments on the relevancy of these data elements with
respect to nanoscale and questioned whether there were other data
elements that may be more important, are easier to collect or are more
valuable.

A participant noted that octanol/water coefficient and volatilization
data are likely not needed.

EPA indicated that it may be valuable to review the Environmental
Defense/Dupont Framework to compare lists of data elements and note that
the OECD’s working group efforts would also be considered.

A participant representing a mid-sized firm commented that the reporting
format was “impressive and daunting” and resource intensive and that
her firm’s resources were already stretched thin given the European
Commission’s Registration, Evaluation, Authorization and Restriction
of Chemicals (REACH) compliance requirements.  

EPA questioned whether there was a subset of data elements that are most
important and suggested possibly prioritizing these data elements.

One participant noted her expectation that companies would have all of
this information prior to introducing a product/material into commerce. 
She also requested that there be a formal way to substantiate data and
claims to confirm their validity. 

EPA indicated that the usual practice to substantiate data is to request
method protocols and reference information to determine whether GLPs
were followed.  EPA would welcome such information to substantiate the
value of the data.  Additionally, EPA noted that it could request
additional information if necessary.

A participant questioned whether there were other examples of chemicals
on the TSCA Inventory that are listed based on crystalline structures. 
EPA indicated that separate entries can exist if crystalline structures
could be distinguished.

Another participant questioned how the data would be used and raised
concerns over “selective reporting.” He suggested that if certain
data elements were not provided that the submitter be required to state
one of two reasons why: 1) Information not provided because it does not
exist, or 2) Information not provided because of some other reason
(e.g., CBI).  Doing so would help to better characterize the state of
the information.

EPA noted that the proposed NMSP and data submission form encourages
submitters to submit all information, including stating why data is not
available.

Timing and phasing of submissions under the NMSP basic and in-depth
programs and whether approaches for tiering data submissions are
appropriate; 

EPA summarized comments provided earlier in the meeting that a timeframe
from 3 to 9 months was suggested for the general program.

One participant commented that the sooner EPA can collect the basic
program information the better.  She suggested that companies could
document information they currently do not have and note when the
information would likely be available.

Another participant commented that the overall end objective of the
basic program was to obtain information as quick as possible to get a
sense of what materials are out there. The in-depth program should
consider the key questions and the tests required to generate the
information.  The phases should be kept separate and work quickly to
initiate the basic program.

EPA suggested that a different timeline could be developed.  As an
example, rather than allowing two years for the basic program with
interim and final evaluations, establish a three to nine month reporting
period without an interim report and report on the overall assessment in
12 to 15 months.  Companies could submit updated data later.

EPA asked for input on how long it would take to assemble the right
information to conduct a meaningful evaluation.  EPA welcomes comments
on what the appropriate cutoff dates should be for both submission of
the data and EPA reporting the findings of the evaluation.

One participant questioned whether there were different objectives and
requested confirmation that the NMSP was not a substitution for
regulation and protecting human health and the environment.

EPA responded that the NMSP would not continue indefinitely; rather, EPA
would suggest a follow-on program which could have either or both a
voluntary and regulatory program.

A participant questioned whether summaries of raw studies, if written in
different language, must be submitted in English, noting the resource
requirements to translate documents may discourage participation.

EPA indicated that summaries should be submitted in English, but it may
not be necessary to translate the detailed studies.  However, EPA may
request translation of the raw studies if necessary.

A participant questioned how EPA would measure success of the program
– percent of companies or materials represented.

EPA indicated that it will measure the success of the program by the
quality of information that is received and whether it increases and
informs EPA’s knowledge.  This evaluation will help EPA to reasonably
determine what the next steps are. 

A participant questioned what data elements EPA will recommend companies
submit and noted the difficulty of interpreting inconsistently formatted
information.

EPA responded that, for the basic program, EPA wants companies to
provide whatever information is available.  Whether there is a set of
data that EPA would find most useful would most likely come about in the
in-depth program for tiered data. 

EPA also noted that the OECD working group is working on this issue. 
EPA thinks the in-depth program and OECD frameworks will provide the
means to provide a solid scientific understanding of these materials. 
EPA noted that it is possible that a preferred set of data elements
could emerge.

EPA noted several sources that are helping EPA better understand
environmental concerns surrounding nanomaterials, including: EPA’s
White Paper; the Office of Research and Development’s research
framework; ongoing, internal risk assessment case studies; the upcoming
peer consultation on material characterization; and reviews of
nano-sized PMNs.  All of these sources can help EPA to identify data
gaps or improve EPA’s understanding of the materials.

A participant noted that NPPTAC recommendations addressed timing and he
expressed concern about establishing a long-term program without
deadlines.  It was suggested that EPA should consider a second time
period to capture people who were not ready or were not in the market
when the basic program is initiated.  The participant also suggested
that the sign-up period for the basic program be very short.

Another participant encouraged EPA to harmonize its efforts with OECD
for the in-depth program to prevent companies from having to choose one
program over the other and to encourage a parallel effort.

EPA encouraged companies to work together on representative
nanomaterials.  EPA reminded participants that the in-depth program will
include mechanisms to handle proprietary nanomaterials. EPA supports the
convergence of programs and data for representative materials.

Who would participate in the NMSP and how to encourage participation,
especially from small and medium sized enterprises; 

A participant questioned how EPA would know the extent of the
participation level.

EPA responded that the authority afforded by TSCA section 8(a) could
require reporting.  EPA could rely on its rulemaking authority to gain a
comprehensive understanding.

A participant suggested that EPA should actively advertise and market
the NMSP.  EPA could contact state industry councils to help spread the
word.

A participant reiterated his position on having concurrent voluntary and
regulatory programs, and that, if done right, this approach could
provide an incentive for participation by making it clear that if
companies volunteer now, information requirements that will be imposed
later will already be satisfied and recognize those companies that
volunteer.

EPA requested suggestions on the best way to reach businesses and target
stakeholders that may not know they are stakeholders for potential
workshops.  EPA would like ideas on the types of training to hold before
the program is initiated and commented that holding additional training
workshops once the program is underway is a good idea.

A participant reminded EPA of the success of the 33-50 program and the
technical workshops that were held to increase understanding on how to
participate.

What criteria to use for NMSP program evaluation and views on the timing
and nature of any reports the Agency may issue;  

Participants had no general comments regarding this question. 

How to engage industry and other stakeholders in the NMSP in-depth
program and approaches for generating test data; 

Participants had no general comments regarding this question. 

The processes and roles for EPA, participants, and other stakeholders
during development and evaluation of data for the in-depth program; 

Participants had no general comments regarding this question. 

Possible approaches for identification and use of alternative sources of
data, in order to minimize the burden of information collection
associated with the NMSP; 

A participant urged harmonization of efforts among countries and noted
that expert judgment will take precedence for the near term and EPA
should determine how best to integrate expert judgment. The participant
suggested developing a framework or quantifiable way to integrate data
to make the information useful.

Uses for the data submitted to EPA under the NMSP program;  

Participants had no general comments regarding this question. 

EPA commented that there is a focus on data use scenarios and EPA would
like a reaction to those, as well as understanding other data uses.

Issues relevant to scope, definitions and descriptions; 

A participant questioned the distinction between films and coatings. 

A significant discussion ensued regarding various specific examples. EPA
welcomed suggestions for a better way to characterize the scope. 

A participant noted that the American Chemistry Council provides a
discussion of various nanotechnology terms on their Web site.

The suitability of the approach for determining the TSCA Inventory
status of nanoscale materials discussed in the Inventory paper; and, 

Participants had no general comments regarding this question. 

Whether, in combination, the TSCA Inventory paper and the NMSP concept
paper are sufficiently clear in how EPA plans at this time to address
nanoscale materials that are new or existing chemicals under TSCA and
the NMSP.  

Environmental Defense indicated that the documents are not adequate,
noting and reiterating comments that were made earlier in the meeting. 

A participant indicated that EPA should clearly describe what its intent
and current thinking is regarding the approach for addressing concerns
surrounding nanomaterials (i.e., use the authorities listed, wait and
see, start in parallel, etc.).

EPA indicated that, at this time, no decisions on regulations have been
made.  However, EPA is committed to a collaborative process whereby
stakeholders are given the opportunity to help shape the program, in
part through meetings such as today’s.  

A participant questioned clarification on TSCA section 8(e) reporting as
it relates to nanoscale materials. 

EPA indicated that all materials subject to TSCA are subject to 8(e),
including nanoscale materials.  Further, EPA has received some 8(e) data
on nanoscale materials, and if EPA determines additional information is
needed, a request will be submitted to the company.  EPA has
consistently requested additional data about size and phenomena on
nanoscale materials (both new and 8e submissions).

	The meeting concluded by EPA reminding stakeholders that five weeks
remain in the public comment period.  EPA encouraged stakeholders to
re-review the materials and to take advantage of clarifications and
comments made today when preparing written comments for submission to
the Docket. In addition, EPA requested that participants submit other
materials that would inform the process and facilitate further
understanding of all stakeholders.  Charlie Auer indicated that EPA’s
intention is to launch the NMSP by the end of the calendar year.

Appendix A

AGENDA

	

	United States 	

	Environmental Protection Agency

Public Meeting on the

Nanoscale Materials Stewardship Program

Holiday Inn Rosslyn at Key Bridge

Arlington, Virginia

August 2, 2007

Agenda

8:30 AM	Registration

9:00 AM	Welcome/Introductory Remarks – Jim Willis  

9:10 AM	Keynote Remarks - Jim Gulliford 

9:20 AM	Purpose – Nanoscale Materials Stewardship Program – Charlie
Auer

9:40 AM  	Carolyn Nunley Cairns, Consumers Union

		Bill Gulledge, American Chemistry Council

		Richard Denison, Environmental Defense

		Bernard Made, Environment Canada

	

10:40 AM	Break

11:00 AM	Scott Slaughter, The Center for Regulatory Effectiveness

		Terry Davies, Woodrow Wilson Center 

		James Cooper, Synthetic Organic Chemical Manufacturers Association

		Igor Linkov, Intertox, Inc. 

12:00 PM	Lunch

1:15 PM	Registered Speakers/Open Public Comments

2:45 PM	Break

3:00 PM	Register Speakers/Open Public Comments

4:15 PM	Wrap-up/Next StepsAppendix B

		United States 	

	Environmental Protection Agency

Public Meeting on the

Nanoscale Materials Stewardship Program



Holiday Inn Rosslyn at Key Bridge

Arlington, Virginia

August 2, 2007

Final List of Observers

Norris Alderson

Associate Commissioner for Science

U.S. Food and Drug Administration

5600 Fishers Lane (HF-32)

Rockville, MD 20857

301-827-3340

Email: norris.alderson@fda.hhs.gov

Mohammad Ali

Manager, Compliance & Quality Systems

Nanophase Technologies Corporation

453 Commerce Street 

Burr Ridge, IL 60527

630-323-4130

Fax: 630-323-9658

Email: mali@nanophase.com

Jim Alwood

OPPT/CCD

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7405M)

Washington, DC 20460

202-564-8974

Fax: 202-564-9490

Email: alwood.jim@epa.gov

Paul Anninos

SVP

ICF International

9300 Lee Highway 

Fairfax, VA 22031

703-934-3969

Email: panninos@icfi.com

Jay Ansell

Senior Director

The Cosmetic, Toiletry, and 

Fragrance Association (CTFA)

1101 17th Street, NW 

Washington, DC 20036

202-331-1770

Email: ansellj@ctfa.org

Jesse Ash

Associate 

Reed Smith LLP 

1301 K Street, NW 

Suite 1100 - East Tower 

Washington, DC 20005

202-414-9255 

Fax: 202-414-9299

Email: jash@reedsmith.com 

Andy Atkinson

Head, New Chemicals Evaluation

New Substances Division

Science and Risk Assessment Directorate

Environment Canada

351 St-Joseph Boulevard – PVM - 14th Floor

Gatineau, Québec J8Y 3Z5

Canada

819-997-3202

Fax: 819-953-7155

Email: andy.atkinson@ec.gc.ca

Charles Auer

Director

Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7401M)

Washington, DC 20460

202 564-3810

Fax: 202 564-0575

Email: auer.charles@epa.gov

John Balbus

Chief Health Scientist

Environmental Defense

1875 Connecticut Avenue, NW - Suite 600

Washington, DC 20009

202-387-3500

Email: jbalbus@environmentaldefense.org

Brenda Barry

Senior Toxicologist

ENSR

2 Technology Park Drive 

Westford, MA 01886

978-589-3075

Email: bbarry@ensr.aecom.com

Nancy Beck

Policy and Scientific Advisor

Physicians Committee for Responsible Medicine

5100 Wisconsin Avenue - Suite 400

Washington, DC 20016

Email: nbeck@pcrm.org

Lynn Bergeson

Managing Director

Bergeson & Campbell, P.C.

1203 Nineteenth Street, NW - Suite 300

Washington, DC 20036

202-557-3801

Fax: 202-557-3836

Email: lbergeson@lawbc.com

Ron Bloom

Environmental Officer

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

10903 New Hampshire Avenue 

Silver Spring, MD 20993

301-796-2185

Email: raanan.bloom@fda.hhs.gov

Elizabeth Buckley

Assistant Editor

Pesticide & Toxic Chemical News

2200 Clarendon Boulevard - Suite 1401

Arlington, VA 22201

703-527-1680 x122

Email: elizabeth.buckley@informa.com

Bruce Buxton

Senior Program Manager

Battelle

505 King Avenue 

Columbus, OH 43201

614-424-4547

Email: buxtonb@battelle.org

Carolyn Cairns

Program Leader, Product Safety

Product Safety Department

Technical Division

Consumers Union

101 Truman Avenue 

Yonkers, NY 10703

914-378-2303

Email: cairca@consumer.org

Richard Canino

Policy Researcher

N.E.D.O

2000 L Street NW - Suite 605

Washington, DC 20008

202-822-9298

Email: rcanino@nedodc.org

Patricia Casano

Counsel, Government Affairs

Corporate Environmental Programs

General Electric Company

1299 Pennsylvania Avenue, NW 

Suite 900 - West

Washington, DC 20004

202-637-4228

Fax: 202-637-4017

Email: pat.casano@ge.com

Rhitu Chatterjee

Reporter

Environmental Science and Technology

American Chemical Society

1155 16th Street, NW – Room 718

Washington, DC 20063

202-872-4541

Email: r_chatterjee@acs.org

Natalie Chin

Project Assistant

Project on Emerging Nanotechnologies

Woodrow Wilson International 

Center for Scholars

1300 Pennsylvania Avenue, NW 

Washington, DC 20004

202-691-4318

Email: natalie.chin@wilsoncenter.org

Myrta Christian

OPPT/EETD/ICB

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7201M)

Washington, DC 20460

202-564-8498

Email: christian.myrta@epa.gov

Shaun Clancy

Director - Product Regulatory Services

Degussa

379 Interpace Parkway 

Parsippany, NJ 07054

973-541-8047

Email: shaun.clancy@degussa.com

James Cooper

Senior Manager, Chemicals Policy

Synthetic Organic Chemical 

Manufacturers Association

1850 M Street, NW - Suite 700

Washington, DC 20036

202-721-4100

Email: cooperj@socma.com

Raymond David

Manager, Toxicology

BASF Corporation

100 Campus Drive 

Florham Park, NJ 07932

973-245-6858

Email: raymond.david@basf.com

Clive Davies

Chief

OPPT/EETD/DfE

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7406M)

Washington, DC 20460

202-564-3821

Email: davies.clive@epa.gov

Terry Davies

Senior Advisor 

Woodrow Wilson Center Project on Emerging Nanotechnologies

One Woodrow Wilson Plaza

1300 Pennsylvania Avenue, NW

Washington, DC 20004

202-691-4398 

Fax: 202-564-9490

James Delahay

Product Regulatory Specialist

BASF Corporation

1609 Biddle Avenue 

Wyandotte, MI 48192

734-324-5110

Email: james.delahay@basf.com

Paul DeLeo

Director, Environmental Safety

The Soap and Detergent Association

1500 K Street, NW - Suite 300

Washington, DC 20005

202-662-2516

Fax: 202-347-4110

Email: pdeleo@sdahq.org

Richard Denison

Senior Scientist

Environmental Defense

1875 Connecticut Avenue, NW - Suite 600

Washington, DC 20009

202-387-3500

Fax: 202-234-6049

Email: rdenison@environmentaldefense.org

John DiLoreto

Principle

NanoReg

Darnestown, MD 20878

301-987-0924

Email: johnd@nanoreg.net

Michael DiRienzo

Executive Director

Silver Institute

1200 G Street - Suite 800

Washington, DC 22302

202-835-0185

Fax: 202-835-0155

Email: mdirienzo@silverinstitute.org

Timothy Dole

Industrial Hygienist

OPP/HED

U.S. Environmental Protection Agency

One Potomac Yard (South Building)

2777 South Crystal Drive (7509P)

Arlington, VA 22202

703-305-6450

Email: dole.timothy@epa.gov

Eric Dubé

Technical & Regulatory Analyst

Steptoe & Johnson

1330 Connecticut Avenue, NW 

Washington, DC 20036

202-862-5765

Email: edube@steptoe.com

Jeremiah Duncan

AAAS Science Policy Fellow

OPPT/ORD

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW 

Washington, DC 20560

202-564-1117

Email: duncan.jeremiah@epa.gov

David Eberly

Burke, VA 22015

703-308-8645

John Festa

Senior Scientist

American Forest and Paper Association

1111 19th Street, NW 

Washington, DC 20036

202-463-2587

Colin Finan

Managing Editor, Environmental Policy Alert

Inside Washington Publishers

1225 South Clark Street - Suite 1400

Arlington, VA 22202

703-416-8564

Email: cfinan@iwpnews.com

Greg Fritz

OPPT/ICB

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7406M)

Washington, DC 20460

202-564-8583

Email: fritz.greg@epa.gov

Ray Garant

Assistant Director, Public Policy

Legislative and Government Affairs

American Chemical Society

1155 16th Street, NW

Washington, DC 20036

202-872-6063

Email: r_garant@acs.org

Mark Garvey

Attorney

Enforcement

Waste & Chemicals Enforcement

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (2245A)

Washington, DC 20460

202-564-4168

Email: Garvey.Mark@epa.gov

Josie Gaskey

Exec VP & COO

The Annapolis Center for 

Science-Based Public Policy

111 Forbes Street - Suite 200

Annapolis, MD 21401

410-268-3302

Fax: 410-268-4593

Email: jgaskey@annctr.org

Sarah Gerould

Program Coordinator, Contaminant Biology Program

U.S. Geolgocial Survey

12201 Sunrise Valley Drive (301)

Reston, VA 20192

703-648-6895

Email: sgerould@usgs.gov

Douglas Green

Healthy Environments and 

Consumer Safety Branch

New Substances 

Assessment and Control Bureau

Health Canada

123 Slater - 5th Floor (AL 3505A)

MacDonald Building

Ottawa, Ontario K1Y 1E8

Canada

613-946-8021

Fax: 613-946-6474

Email: doug_green@hc-sc.gc.ca

Mark Greenwood

Partner

Ropes & Gray

700 12th Street - Suite 900

Washington, DC 20005

202-508-4605

Email: Mark.Greenwood@ropesgray.com

Bill Gulledge

Managing Director

Manager, Nanotechnology Panel

Chemical Products & Technology Division

American Chemistry Council

1300 Wilson Boulevard - 10th Floor

Arlington, VA 22209

703-741-5613

Fax: 703-741-6091

Email: william_gulledge@

americanchemistry.com

James Gulliford

Assistant Administrator

Office of Prevention, Pesticides and Toxic Substances

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7101M)

Washington, DC 20460

202-564-2902

Email: gulliford.jim@epa.gov

Akinori Haratake

Director

Kanebo Cosmetics, Inc.

580 Broadway - Suite 1004

New York, NY 10012

646-613-7631

Fax: 646-613-1378

Email: haratake@kanebo.com

Stacey Harper

Research Associate

Oregon State University

1007 ALS 

Corvallis, OR 97331

541-737-2791

Email: harpers@science.oregonstate.edu

Kathy Hart

Environmental Protection Specialist

OPPT/EETD/DFE

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7406M)

Washington, DC 20460

202-564-8787

Email: hart.kathy@epa.gov

Tucker Helmes

Senior Director

VISIONS

Synthetic Organic Chemical 

Manufacturers Association

1850 M Street, NW - Suite 700

Washington, DC 20036

202-721-4154

Fax: 202-296-8120

Email: helmest@socma.com

Jessica Hejny

Environmental Defense

202-387-3411

Email: jhejny@environmentaldefense.org

Mark Herwig

CMP Program Manager

GE Corporate Environmental Programs

3135 Easton Turnpike (W1B)

Fairfield, CT 06828

203-373-2817

Email: Mark.Herwig@ge.com

Melissa Hockstad

Senior Technical Director

The Society of the Plastics Industry

1667 K Street, NW - Suite 1000

Washington, DC 20006

202-974-5258

Email: mhockstad@socplas.org

Leah Humes

Researcher

Food & Water Watch

1400 16th Street, NW - Suite 225

Washington, DC 20036

202-797-6567

Email: lhumes@fwwatch.org

Ian Illuminato

Health and Environment Campaigner

Friends of the Earth

1717 Massachusetts Avenue, NW

Suite 600

Washington, DC 20036

202-222-0735

Email: iilluminato@foe.org

Robert Johnston, Jr.

Latham & Watkins LLP

555 Eleventh Street, NW - Suite 1000

Washington, DC 20004

202-637-1086

Fax: 202-637-2201

Email: robert.johnston@lw.com

Lina Karaoglanova

Program Assistant

American Association for the Advancement of Science

1200 New York Avenue, NW

Washington, DC 20005

202-326-6789

Email: lkaraogl@aaas.org

Zofia Kosim

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (2242A)

Washington, DC 20460

202-564-8733

Email: kosim.zofia@epa.gov

Mary Kavanagh

Science Counselor

European Commission Delegation to the USA

2300 M Street, NW

Washington, DC 20007

George Kimbrell

Staff Attorney

International Center for Technology Assessment

John Kowalski

Senior Regulatory Specialist

ChemADVISOR, Inc.

811 Camp Horne Road - Suite 220

Pittsburgh, PA 15237

412-847-2000

Fax: 412-847-2010

Email: jkowalski@chemadvisor.com

Kristen Kulinowski

Director, International Council on Nanotechnology; 

Executive Director, Center for 

Biological & Environmental Nanotechnology

Rice University (MS 60)

Department of Chemistry - P.O. Box 1892

Houston, TX 77251-1892

713-348-8211

Email: kk@rice.edu

Ronke Lawal

Keller & Heckman

Stephen Lehrman

Legislative Assistant

Office of Senator Mark Pryor

255 Dirksen Senate Office Building 

Washington, DC 20510

202-224-2353

Email: Stephen_Lehrman@pryor.senate.gov

Barbara Leifheit

President

Leifheit & Company, Inc.

1840 Brandon Lane 

Racine, WI 53406

262-884-0670

Fax: 262-884-0672

Email: bleifheit@aol.com

Deanna Lekas

Program Associate

Woodrow Wilson Center Project on Emerging Nanotechnologies

One Woodrow Wilson Plaza 

1300 Pennsylvania Ave, NW

Washington, DC 20004

202-691-4398

Email: deanna.lekas@wilsoncenter.org

Jason Leuck

Director, Government & Regulatory Affairs

Washington Operations

Lockheed Martin Corporation

1550 Crystal Drive - Suite 300

Arlington, VA 22202

703-413-5810

Email: jason.leuck@lmco.com

Daniel Lin

Chemist

OPPT/EETD/ICB

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7406M)

Washington, DC 20460

202-564-8584

Email: lin.chuantung@epa.gov

Igor Linkov

Managing Scientist and Adjunct Professor of Engineering and Public
Policy

Intertox Inc. and Carnegie Mellon University

83 Winchester Street - Suite 1

Brookline, MA 02446

617-233-9869

Fax: 617-225-0813

Email: ilinkov@yahoo.com

David Lutter

Intern Analyst

U.S. Government Accountability Office

441 G Street, NW 

Washington, DC 20548

202-512-7792

Email: lutterd@gao.gov

Bernard Made

Director

Science and Technology Branch

New Substances Division

Environment Canada

351 St-Joseph Boulevard - 14th Floor

Gatineau, Canada J8Y 3Z5

819-997-4336

Fax: 819-953-7155

Email: bernard.made@ec.gc.ca

Cathy Malina

Program Associate

Environmental Defense

1875 Connecticut Avenue, NW - Suite 600

Washington, DC 20009

202-387-3500

Email: cmalina@environmentaldefense.org

Mark Mansour

Partner

Foley & Lardner LLP

3000 K Street, NW - Suite 500

Washington, DC 20007

202-672-5585

Email: mmansour@foley.com

Martha Marrapese

Attorney

Keller & Heckman LLP

1001 G Street, NW 

Washington, DC 20001

202-434-4123

Fax: 202-434-4646

Email: marrapese@khlaw.com

Nathanial Martin

Economic/Policy Analyst

OPP

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7500P)

Washington, DC 20460

703-305-6475

Email: martin.nathanael@epa.gov

Erin McNeill

Reporter

CQ

202-419-8268

Terry Medley

Global Director

Corporate Regulatory Affairs

Environmental  & Sustainable 

Growth Center

DuPont

1007 Market St D-6070 

Wilmington, DE 19382

302-773-3191

Fax: 302-774-1361

Email: terry.l.medley@usa.dupont.com

Celia Merzbacher

Executive Director, PCAST

Assistant Director for Technology R&D

Office of Science and Technology Policy

Executive Office of the President

Washington, DC

202-456-6108

Email: cmerzbacher@ostp.eop.gov

Ed Messina

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (2245A)

Washington, DC 20460

202-564-1191

Email: messina.edward@epa.gov

John Monica

Partner

Porter Wright Morris & Arthur LLP

1919 Penn Avenue, NW -Suite 500

Washington, DC 20006

202-788-3050

Email: jmonica@porterwright.com

Vladimir Murashov

National Institute for 

Occupational Safety and Health

395 E Street, SW - Suite 9200

Washington, DC 20201

202-245-0668

Sean Murdock

Executive Director

NanoBusiness Alliance

4901 Searle Parkway - Suite Q3606

Skokie, IL 60077

847-568-8413

Email: sean@nanobusiness.org

Irena Myers

OPPT/EAD/LB

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7408M)

Washington, DC 20460

202-564-8822

Email: myers.irina@epa.gov

James Nash

Reporter

ORC Worldwild

1800 K Street, NW

Washington, DC 20005

202-293-2960

Email: jim.nash@orcww.com

Richard Opatick

Consultant

Nanotechnology SME 

Manufacturers Association

1850 M Street, NW - Suite 700

Washington, DC 20036

202-255-9034

Email: ropatick@verizon.net

Marti Otto

Environmental Engineer

Technology Assessment

Technology Innovation & Field Services

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (5203P)

Washington, DC 20460

703-603-8853

Fax: 703-603-9135

Email: otto.martha@epa.gov

Joanne Papineau

Evaluation Specialist

Science and Technology Branch

New Substances Division

Environment Canada

Place Vincent Massey - 14th Floor 

351 St. Joseph Boulevard

Gatineau, Québec K1A 0H3

Canada

819-997-2721

Fax: 819-953-7155

Email: joanne.papineau@ec.gc.ca

Sandra Pecina

Partner and Media Relations Director

The Aker Partners, Inc.

2000 K Street, NW - Suite 801

Washington, DC 20006

202-789-2424

Email: specina@akerpartners.com

Dianne Poster

Research Chemist

Chemical Science and 

Technology Laboratory

National Institute of 

Standards and Technology

100 Bureau Drive (MS8392)

Gaithersburg, MD 20899

301-827-6686

Email: poster@nist.gov

Scott Prothero

Chemical Engineer

OPPT/EETD/CEB

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7406M)

Washington, DC 20460

202-564-8514

Abdiel Quetz

Federal Intern

Office of Health Safety and Security

U.S. Department of Energy

8500 Harwood Road, Apartment 7613

N. Richland Hills, TX 76180

817-281-5109

Email: quetz@andrews.edu

Kurt Rindfusz

Chemical Engineer

Eastern Research Group, Inc.

14555 Avion Parkway - Suite 200

Chantilly, VA 20151

703-633-1676

Email: kurt.rindfusz@erg.com

Molly Rodgers

Environmental Scientist

Eastern Research Group, Inc.

14555 Avion Parkway - Suite 200

Chantilly, VA 22033

757-962-4852

Email: molly.rodgers@erg.com

Zubain Saleem

Office of Solid Waste

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (5307P)

Washington, DC 20460

703-308-0467

Email: saleem.zubain@epa.gov

Phil Sayre

Risk Assessment Division/OPPT

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7403M)

Washington, DC 20460

202-564-7673

Email: sayre.phil@epa.gov

Linda-Jo Schierow

Specialist in Environmental Policy

Congressional Research Service

Library of Congress 

101 Independence Avenue, SE

Washington, DC 20540-7450

202-707-7279

Email: Lschierow@crs.loc.gov

Kathleen Sellers

Senior Environmental Engineer

AMEC

2 Robbins Road 

Westford, MA 01886

978-692-9090

Fax: 978-692-6633

Email: kathleen.sellers@amec.com

Susan Sharkey

Chemical Engineer

OPPT/EETD/EPAB

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7406M)

Washington, DC 20460

202-564-8789

Fax: 202-564-8893

Email: sharkey.susan@epa.gov

David Sheets

Senior Fellow

Army Environmental Policy Institute

1550 Crystal Drive - Suite 1301 

Arlington, VA 22202

703-604-2310

Fax: 703-604-2344

Email: david.sheets@hqda.army.mil

Scott Slaughter

The Center for Regulatory Effectiveness

11 DuPont Circle, NW - Suite 700

Washington, DC 20036

202-265-2383

Email: slaughter@mbsdc.com

Reut Snir

Environmental Lawyer

The George Washington University

1500 Massachusetts Avenue, NW 

Suite 455

Washington, DC 20005

202-419-1814

Email: reutsnir@yahoo.com

Jim Solyst

Principal Consultant

ENVIRON Corporation

4350 North Fairfax Drive 

Arlington, VA 22203

703-516-2330

Email: jsolyst@environcorp.com

Douglas Spicuzza

Senior Project Manager

Cummings/Riter Consultants, Inc.

10 Duff Road - Suite 500

Pittsburgh, PA 15235

412-241-4500

Fax: 412-241-7500

Email: dspicuzza@cummingsriter.com

Tzu-Yuan Su

Research Analyst

Washington CORE

4340 East West Highway - Suite 1110

Bethesda, MD 20814

301-654-2915

Email: tzuyuan@wcore.com

Derek Swick

Health Scientist

API

1220 L Street, NW 

Washington, DC 20009

202-682-8341

Email: swickd@api.org

Makito Takami

Chief Representative of 

Washington DC Office

New Energy and Industrial Technology Development Organization

2000 L Street, NW - Suite 605

Washington, DC 20036

202-822-9298

Fax: 202-822-9289

Email: takami@nedodc.org

Stacey-Ann Taylor

Counsel, Government Affairs Division

National Paint & Coatings Association

1500 Rhode Island Avenue, NW

Washington, DC 20005

202-462-6272

Email: staylor@paint.org

Tarell Taylor

OPPT Intern

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW

Washington, DC 20460

202-250-8816

Email: taylor.tarell@epa.gov

Treye Thomas

Toxicologist

Health Sciences

U.S. Consumer Product Safety Commission

4330 East West Highway

Bethesda, MD 20814

301-504-7738

Email: tthomas@cpsc.gov

Marisabel Torres

Government Affairs Associate

Specialty Graphic Imaging Association

10015 Main Street 

Fairfax, VA 22031

703-359-1304

Fax: 703-273-2870

Email: mtorres@sgia.org

Barbara Vogt

Product Stewardship and Regulatory Affairs

Cytec Industries Inc.

1937 W. Main Street 

Stamford, CT 06904

203-321-2303

Fax: 203-321-2978

Email: barbara.vogt@cytec.com

Kathleen Vokes

OPPT/EETD/DfE

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7406M)

Washington, DC 20460

202-564-9910

Email: vokes.kathleen@epa.gov

James Votaw

Counsel

Wilmer Hale

1875 Pennsylvania Avenue, NW 

Washington, DC 20006

202-663-6244

Email: james.votaw@wilmerhale.com

David Wagger

Director of Environmental Management

Institute of Scrap Recycling Industries

1615 L Street, NW - Suite 600

Washington, DC 20036

202-662-8533

Fax: 202-626-0933

Email: DavidWagger@isri.org

Dave Wagner

Office of General Counsel

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (2322A)

Washington, DC 20460

202-564-5557

Email: wagner.david@epa.gov

Meghan Wallace

Program Examiner

Environment Branch

Natural Resources Division

EOP/OMB

725 17th Street, NW - Room 8026 

New Executive Office Building

Washington, DC 20503

202-395-5894

Email: meghan_l._wallace@omb.eop.gov

Scott Walsh

Project Manager

Environmental Defense

1875 Connecticut Avenue, NW - Suite 600

Washington, DC 20009

202-387-3500

Email: swalsh@environmentaldefense.org

Aason Wardak

Nanotechnology Research Associate

Environmental Defense

Email: amw9v@virginia.edu

Katrina White

Environmental Toxicologist

U.S. Food and Drug Administration

5100 Paint Branch Parkway (HFS 246)

College Park, MD 20740

240-994-8351

Fax: 301-436-2976

Email: kewhite2@gmail.com

Tracy Williamson

OPPT/EETD/ICB

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7201M)

Washington, DC 20460

202-564-8569  

Email: williamson.tracy@epa.gov

Jim Willis

Division Director

OPPT/CCD

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7405M)

Washington, DC 20460

202-564-0104

Email: willis.jim@epa.gov

Jane Wishneff

Regulatory Counsel

Consumer Specialty Products Association

900 17th Street - Suite 300 

Washington, DC 20006

202-833-7303

Email: jwishneff@cspa.org

Teena Wooten

Environmental Scientist

Office of Solid Waste

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7201M)

Washington, DC 20460

703-308-8751    

Email: wooten.teena@epa.gov

Denise Wright

Special Assistant

Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (7401M)

Washington, DC 20460

202-564-0185    

Email: wright.denise@epa.gov

Joanne Wyman

Senior Manager

Battelle

1550 Crystal Drive 

Arlington, VA 22202

703-413-7277

Email: wymanj@battelle.org

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