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I U.S. ENVIRONMENTAL PROTECTION AGENCY
XOFFICE OF INSPECTOR GENERAL
EPA Needs to Manage
Nariomaterial Risks More
Effectively
Report No. 12-P-0162
December 29, 2011

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Report Contributors:
Natalie Hanson
Jeffrey Harris
Lauretta A. Joseph
Kalpana Ramakrishnan
Thane Thompson
Abbreviations
CBI
Confidential business information
EPA
U.S. Environmental Protection Agency
FIFRA
Federal Insecticide, Fungicide, and Rodenticide Act
NNI
National Nanotechnology Initiative
NMSP
Nanoscale Materials Stewardship Program
OAR
Office of Air and Radiation
OCSPP
Office of Chemical Safety and Pollution Prevention
OECA
Office of Enforcement and Compliance Assurance
OIG
Office of Inspector General
OMB
Office of Management and Budget
OPP
Office of Pesticide Programs
OPPT
Office of Pollution Prevention and Toxics
ORD
Office of Research and Development
OW
Office of Water
SNUR
Significant New Use Rule
TSCA
Toxic Substances Control Act
Cover photos: From left: hollow silica nanoshells for imaging and targeted drug and gene
delivery treatments for cancer (photo credit William Trogler, Ph.D. and Sadik Esener, Ph.D.);
quantum dots being used to reveal the molecular fingerprints of individual cells for early cancer
detection (photo credit Jian Liu, Ph.D. and Shuming Nie, Ph.D.); ZnO wire arrays (photo credit
Z.L. Wang, Ph.D.); and a 5-micron bead surrounded by 60-nanometer gold particles (photo
credit Ximei Qian, Ph.D. and Shuming Nie, Ph.D.). (photographs courtesy National Cancer
Institute http://nano.cancer.gov/learn/understanding/library.asp)
Hotline
To report fraud, waste, or abuse, contact us through one of the following methods:
e-mail:	OIG Hotline@epa.gov.	write: EPA Inspector General Hotline
phone:	1-888-546-8740	1200 Pennsylvania Avenue NW
fax:	202-566-2599	Mailcode 2431T
online:	http://www.epa.gov/oiq/hotline.htm.	Washington, DC 20460

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*. U.S. Environmental Protection Agency	12-P-0162
I JBL - Office of Inspector General	December 29, 2011
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At a Glance
Why We Did This Review
EPA Needs to Manage Nanomaterial Risks More Effectively
The purpose of this review was
to determine how effectively
the U.S. Environmental
Protection Agency (EPA) is
managing the human health and
environmental risks of
nanomaterials.
Background
Nanomaterials are currently
used in a wide variety of
applications, including
consumer products, health care,
transportation, energy, and
agriculture. The Agency
considers nanomaterials as
chemical substances that are
controlled at the scale of
approximately one-billionth of
a meter. EPA has the authority,
through several environmental
statutes, to regulate
nanomaterials. Although the
development of nanomaterials
and nanomaterial-enhanced
products is expanding rapidly,
the health implications of
nanomaterials have not yet
been determined.
What We Found
We found that EPA does not currently have sufficient information or processes to
effectively manage the human health and environmental risks of nanomaterials.
EPA has the statutory authority to regulate nanomaterials but currently lacks the
environmental and human health exposure and toxicological data to do so
effectively. The Agency proposed a policy under the Federal Insecticide,
Fungicide, and Rodenticide Act to identify new pesticides being registered with
nanoscale materials. After minimal industry participation in a voluntary data
collection program, the Agency has proposed mandatory reporting rules for
nanomaterials under the Federal Insecticide, Fungicide, and Rodenticide Act, and
is also developing proposed rules under the Toxic Substances Control Act.
However, even if mandatory reporting rules are approved, the effectiveness of
EPA's management of nanomaterials remains in question for a number of
reasons:
•	Program offices do not have a formal process to coordinate the
dissemination and utilization of the potentially mandated information.
•	EPA is not communicating an overall message to external stakeholders
regarding policy changes and the risks of nanomaterials.
•	EPA proposes to regulate nanomaterials as chemicals and its success in
managing nanomaterials will be linked to the existing limitations of those
applicable statutes.
•	EPA's management of nanomaterials is limited by lack of risk
information and reliance on industry-submitted data.
These issues present significant barriers to effective nanomaterial management
when combined with existing resource challenges. If EPA does not improve its
internal processes and develop a clear and consistent stakeholder communication
process, the Agency will not be able to assure that it is effectively managing
nanomaterial risks.
For further information, contact
our Office of Congressional and
Public Affairs at (202) 566-2391.
The full report is at:
www.epa.qov/oiq/reports/2012/
20121229-12-P-0162.pdf
What We Recommend
We recommend that the Assistant Administrator for Chemical Safety and
Pollution Prevention develop a process to assure effective dissemination and
coordination of nanomaterial information across relevant program offices. The
Agency agreed with our recommendation and provided a corrective action plan
with milestone dates. This recommendation is open with agreed-to actions
pending.

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
December 29, 2011
MEMORANDUM
SUBJECT: EPA Needs to Manage Nanomaterial Risks More Effectively
Report No. 12-P-0162
FROM: Arthur A. Elkins, Jr.
Inspector General
TO:	Jim Jones
Acting Assistant Administrator for Chemical Safety and Pollution Prevention
This is our report on the subject evaluation conducted by the Office of Inspector General (OIG)
of the U.S. Environmental Protection Agency (EPA). This report contains findings that describe
the problems the OIG has identified and corrective actions the OIG recommends. This report
represents the opinion of the OIG and does not necessarily represent the final EPA position.
Final determinations on matters in this report will be made by EPA managers in accordance with
established audit resolution procedures.
Action Required
Because you have provided a corrective action plan with milestone dates, you are not required
to provide a written response to this report. Should you choose to provide a response, your
response will be posted on the OIG's public website, along with our memorandum commenting
on your response. Your response should be provided as an Adobe PDF file that complies with
the accessibility requirements of Section 508 of the Rehabilitation Act of 1973, as amended.
The final response should not contain data that you do not want to be released to the public; if
your response contains such data, you should identify the data for redaction or removal. We
have no objections to the further release of this report to the public. We will post this report to
our website at http://www.epa.gov/oig.
If you or your staff have any questions, please contact Wade Najjum at (202) 566-0827 or
naiiurn. wade@epa.gov; Jeffrey Harris at (202) 566-0831 or harris.ieffrev@epa.gov; or Lauretta
Joseph, Project Manager, at (212) 637-3049 or ansah.lauretta@epa.gov.
^EDSX
* JL \
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EPA Needs to Manage Nanomaterial Risks
More Effectively
12-P-0162
Table of C
Chapters
1	Introduction		1
Purpose		1
Background		1
Prior Reports		7
Noteworthy Achievements		7
Scope and Methodology		8
2	EPA Does Not Have Sufficient Information and Processes to
Effectively Manage Nanomaterial Risks		9
Formal Coordination Process Needed to Prioritize Work and
Assess Nanomaterial Risks		9
EPA Should Improve Communicating Nanomaterial Information to the
General Public		10
Existing TSCA Limitations Challenge Nanomaterial Management		10
Limitations in Detection and Assessment Inhibit
Effective Management		11
Conclusions		11
Recommendation		12
Agency Comments and OIG Evaluation		12
Status of Recommendations and Potential Monetary Benefits		13
Appendices
A Agency Response and OIG Comment	 14
B Distribution	 23

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Chapter 1
introduction
Purpose
The purpose of this review was to determine how effectively the U.S.
Environmental Protection Agency (EPA) is managing the human health and
environmental risks of nanomaterials.
Background
Nanomaterials encompass a wide range of substances based on the understanding
and control of matter at the scale of nanometers—the equivalent of one-billionth
of a meter. Nanomaterials are nanoscale materials or materials that contain
nanoscale structures internally or on their surfaces. Nanomaterials are currently
used in a wide variety of applications, including consumer products, health care,
transportation, energy, and agriculture. While some nanomaterials can occur
naturally, this report focuses on intentionally manufactured nanomaterials.
Figure 1 illustrates the relative size of nanomaterials.
Figure 1: Size and scale of nanomaterials
DNA
2J lumyivfim
diameter
Bacterium
2-5 m*romft(o
long
x 100.000
Strand of Hair
lOOmKftuww-rt
dimeter
House
lOmetffi
1 00,000
l.OOO
Single-walled
Carbon Nanotobe
1 nanometer diameter
Source: National Nanotechnology Institute website.
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Though the development of nanomaterials and nanomaterials-enhanced products
is expanding rapidly, the health or environmental implications of nanomaterials
have not yet been determined.1 Research has shown that exposure to
nanomaterials may produce effects that differ from those observed with
conventionally scaled materials. Some nanomaterials may cross the human blood-
brain or placental barrier in ways that larger particles cannot.2'3
The many applications of nanomaterials present new opportunities to improve
products, processes, and technologies. Some of these applications may improve
how contaminants are measured, monitored, managed, and minimized in the
environment. However, there also exists the potential for exposures to
nanomaterials during product manufacturing, use, and/or at the end of the product
life cycle through recycling, landfills, and waste incineration. Depending on the
individual properties, nanomaterials may be able to enter the human body through
the skin, through ingestion, and through inhalation. For example, because some
carbon nanotubes resemble asbestos fibers, researchers are questioning whether
they may lead to diseases such as mesothelioma. Further, research has shown that,
when combined with ultraviolet light and sweat, nanotitanium dioxide in
sunscreen is capable of altering proteins in the skin. More research is needed to
determine whether this may cause skin diseases.
Risks to public health are dependent, in part, on exposure. Public exposure has
likely been limited to date. Table 1 illustrates examples of commercial
applications of nanomaterials and their respective potential routes of exposure to
the public.
1	EPA's website states that in some cases there may be beneficial characteristics of nanomaterials when used for
drug delivery and disease treatments. EPA acknowledges that this characteristic could also result in unintended
impacts for manufactured nanomaterials not designed for disease therapies.
2	P. Wick, A. Malek, P. Manser, D. Meili, X. Maeder-Althaus, L. Diener, P.A. Diener, A. Zisch, H.F. Krug, U. von
Mandach, "Barrier Capacity of Human Placenta for Nanosized Materials", Environmental Health Perspectives, vol.
118, no. 3, pp. 432-6, March 2010.
3	Panyala, NR; Pena-Mendez, EM; Havel, J. (2008). Silver or silver nanoparticles: a hazardous threat to the
environment and human health? Journal of Applied Biomedicine, 6(3): 117-29.
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Table 1: Consumer exposure for several types of nanomaterial products
Product type
Release and/or exposure source
Exposed
population
Potential exposure
route
Sunscreen
Product application by consumer to skin
Consumer
Dermal
Release by consumer to water supply (e.g.,
washing with soap and water)
General
population
Ingestion
Disposal of sunscreen container with residual
sunscreen after use to landfill or incineration
General
population
Inhalation or ingestion
Paints and
coating
Weathering, disposal
Consumers,
general population
Dermal, inhalation or
ingestion
Clothing
Wear, washing, disposal
Consumers,
general population
Dermal, inhalation,
ingestion from surface
or ground water
Electronics
Release at end of life or recycling stage
Consumers,
general population
Dermal, ingestion from
surface or ground
water
Sporting goods
Release at end of life or recycling stage
Consumers,
general population
Dermal, inhalation,
ingestion from surface
or ground water
Source: EPA, Nanotechnology White Paper, 2007.
In 2010, federal support of nanomaterial research and development totaled
$1.9 billion. Federal research and development efforts are coordinated by the
National Nanotechnology Initiative (NNI). The NNI creates a framework for
shared goals, priorities, and strategies for each federal agency to leverage the
resources of all participating agencies. Along with 25 other federal agencies, EPA
works with the NNI to conduct research on nanomaterials.
EPA is one of nine federal agencies that dedicate funding to identify any potential
adverse effects of nanomaterials and the risks these nanomaterials pose to human
health and the environment. Each size, formulation, and application of a
nanomaterial used as a pesticide or industrial chemical could potentially introduce
a unique risk that EPA is required to understand and address.
EPA's Approach to Managing Nanomaterials
EPA has the statutory authority to regulate nanomaterials during various stages of
their production, use, and disposal. EPA can regulate nanomaterials during their
manufacture, formulation, distribution in commerce, use, and/or disposal through
the Toxic Substances Control Act (TSCA). EPA can regulate nanomaterials in
pesticides through the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), the authority under which EPA regulates the sale, distribution, and use
of pesticide products in the United States. EPA can regulate nanomaterials
released into the environment using the Clean Air Act; the Clean Water Act; the
Comprehensive Environmental Response, Compensation and Liability Act; or the
Resource Conservation and Recovery Act.
EPA oversees the management of nanomaterial products. The Office of Chemical
Safety and Pollution Prevention (OCSPP) stated that since 2005 it has received
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and reviewed over 120 new chemical notices under TSCA for nanoscale
materials, including carbon nanotubes. EPA's management of nanomaterials
under TSCA has evolved from a voluntary approach to a regulatory approach. In
January 2008, EPA began collecting data from manufacturers using the voluntary
Nanoscale Materials Stewardship Program (NMSP). EPA sought information on
production, importation, and use; exposures; risk management practices; hazards;
pollution prevention; and physical and chemical properties. EPA scientists
intended to use data collected through this program, where appropriate, to aid in
determining how and whether certain nanoscale materials or categories of
nanoscale materials present risks to human health and the environment. Although
29 companies provided data that described or identified 123 nanomaterials, only 4
companies were willing to participate in the portion of the program that
encouraged them to sponsor the development of test data and provide that
information to EPA. Based on the limited response to the program, EPA
discontinued the NMSP in December 2009 and began developing regulatory
approaches under Sections 5 and 8(a) of TSCA to collect nanomaterial data from
manufacturers of industrial chemicals.
As shown in table 2, EPA is developing proposals for new data reporting
requirements for FIFRA and TSCA. In July 2010, EPA submitted a request for a
modification of FIFRA to the Office of Management and Budget (OMB). This
submission sought to clarify the information collection ability of FIFRA
regulations by including a description of nanomaterials in the policy, which would
require manufacturers to submit more nano-specific data. In October 2010, EPA
submitted a proposed TSCA revision to OMB. Under this proposal, any chemical
substance from 1 to 100 nanometers will be subject to TSCA's Significant New
Use Rule (SNUR). This regulatory revision treats the nanomaterial as a new
chemical and requires submission of data to EPA at least 90 days prior to
commencing manufacture of these types of materials.
On June 17, 2011, EPA issued a Federal Register notice (76 FR 35383) seeking
comments on how the Agency could use FIFRA Section 6(a)(2) or FIFRA
Section 3(c)(2)(B) to gain information on what nanoscale materials are in
pesticide products. The notice also proposed a policy of classifying any
application for registration of a pesticide product containing nanoscale material as
an application for a "new" active or inert ingredient.
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Table 2: New and existing regulations affecting nanomaterials
Regulation
Description
Status
TSCA 5(a)(2)
Nanomaterial SNUR
This change under TSCA would require that production of certain
new nanoscale materials would constitute a significant new use
of a chemical substance. Manufacturers must notify EPA at least
90 days before starting production to provide EPA the
opportunity to evaluate the intended use and, if necessary, to
prohibit or limit its use.
Awaiting OMB approval
TSCA 8(a)
Information Gathering
This change under TSCA would require that persons who
manufacture nanomaterials already in commerce notify EPA of
information including production volume, methods of
manufacture and processing, exposure and release information,
and available health and safety data.
Awaiting OMB approval
TSCA Section 5 New
Chemical Review
OCSPP stated that since 2005 it has received and reviewed over
120 new chemical notices under TSCA for nanoscale materials,
including carbon nanotubes. The Agency has taken a number of
actions to control and limit exposures to these chemicals utilizing
its authority under TSCA Sections 5(e) and 5(a) (2).
Ongoing
FIFRA
6(a)(2) or 3(c)(2)(b)
EPA issued a Federal Register notice on June 17, 2011, seeking
comments on how the Agency could use FIFRA Section 6(a)(2)
or FIFRA Section 3(c)(2)(B) to gain information on what
nanoscale materials are in pesticide products. The notice also
proposed a policy of classifying any application for registration of
a pesticide product containing nanoscale material as an
application for a "new" active or inert ingredient.
Proposal currently
undergoing revisions by
EPA
Source: OIG analysis.
Until the TSCA and FIFRA reporting requirements are complete, EPA will
continue to lack the information to determine how and whether certain nanoscale
materials or categories of nanoscale materials present risks to human health and
the environment.
EPA has determined that nanomaterials will be regulated under existing statutes
for chemicals. Therefore, EPA's effectiveness in managing nanomaterials will
depend upon the effectiveness of its existing regulatory frameworks under FIFRA
and TSC A. In our 2010 evaluation of TSC A's New Chemicals Program, we
identified a number of shortcomings:
•	The program was limited by an absence of toxicity testing and
environmental fate data, and a reliance on modeling, as TSCA does not
require upfront testing. Because EPA depends on information reported by
industry, it can initially fail to identify chemical risks not self-disclosed by
manufacturers.
•	The program was limited by TSCA's requirement to protect claims of
confidential business information (CBI) on industry data submissions. The
report stated that the Office of Pollution Protection and Toxics (OPPT)
Chief of TSCA Security Staff estimated that up to 90 percent of TSCA
premanufacture notices contain claims of CBI. Excessive CBI
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designations inhibit independent peer reviews, oversight by external
parties, and information sharing across EPA offices.
Program Office Roles and Authority to Regulate Nanomaterials
The majority of EPA's nanomaterial funding has been appropriated to the Office
of Research and Development (ORD) to conduct research on nanomaterials.
According to the Office of Chemical Safety and Pollution Prevention, it was the
first to regulate nanomaterials based on the new chemical requirements under
TSCA Section 5(e).
Office of Research and Development
ORD is leading scientific efforts to understand the potential risks to
human health and the environment from exposure to nanomaterials. In
2008, ORD created the Nanomaterials Research Strategy document to help
guide the Agency in answering key science questions regarding the
source, fate, exposure, risk assessment, and risk management of
nanomaterials. In 2010, EPA received approximately $18 million for
nanotechnology research efforts, and ORD had approximately 35 full-time
equivalents4 engaged in both research and grant oversight. ORD plans to
incorporate nanomaterial research into a broader Chemical Safety and
Sustainability Research Program. According to ORD, this program is
intended to combine the use of high-throughput chemical screening and
prioritization approaches used in other toxicology efforts with ongoing
nanomaterial research. An ORD representative stated that if the TSCA and
FIFRA regulatory changes take effect, the additional information that
could be collected would be used to guide ORD's research efforts as the
Chemical Safety and Sustainability Research Program evolves into an
integrated chemicals-related research program.
Office of Chemical Safety and Pollution Prevention
OCSPP reviews, regulates, and evaluates the risks of industrial chemicals
and pesticides sold in and imported into the United States. OCSPP
currently has approximately five full-time equivalents working on
nanomaterial activities. Within OCSPP are OPPT and the Office of
Pesticide Programs (OPP). The primary responsibility of OPPT is to
implement TSCA and the Pollution Prevention Act. Under these laws,
EPA evaluates new and existing chemicals and their risks, and finds ways
to prevent or reduce pollution before it enters the environment. OPPT also
seeks to promote understanding of chemical risks by providing
information to the public. OPP is responsible for reviewing and registering
pesticides under FIFRA. One of OPP's primary efforts is evaluating
4 FTE employment is the total number of hours worked, divided by the compensable hours applicable to each fiscal
year. There are about 60 ORD scientists who spend some of their time on nanomaterials-related research.
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potential new pesticides. Nanomaterials are currently being included in
some pesticides. As nanomaterials become more widely used in
commerce, OPP expects that the need to review different types of
nanomaterial formulations will increase.
Other EPA Program Offices
Several other EPA program offices have the statutory authority to regulate
nanomaterials to address risks posed in the environment. The Office of Air
and Radiation (OAR), the Office of Solid Waste and Emergency
Response, and the Office of Water (OW) all have statutory authority to
regulate nanomaterials in their respective environmental media.
Additionally, the Office of Enforcement and Compliance Assurance
(OECA) will have the responsibility to enforce any regulations upon
enactment.
Prior Reports
In the EPA Office of Inspector General (OIG) Report No. 10-P-0066, EPA Needs
a Coordinated Plan to Oversee Its Toxic Substances Control Act Responsibilities,
issued February 17, 2010, we found that EPA's management of chemical risks
under TSCA was limited by an absence of chemical test data, reliance on risk
modeling rather than on actual test results, and a lack of transparency. The report
also stated that oversight of regulatory actions designed to reduce known risks
was a low priority, and that the resources allocated by EPA were not
commensurate with the scope of monitoring and oversight work. In addition, we
found that EPA's procedures for handling CBI requests were predisposed to
protect industry information rather than to provide public access to health and
safety studies.
The U.S. Government Accountability Office issued Report 10-549,
Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in
Regulating Risk, in May 2010. This report reviewed the current prevalence of
nanoscale materials in commerce, discussed the challenges related to regulating
nanoscale materials, and recommended that EPA utilize the authorities of FIFRA
and TSCA to regulate nanomaterials.
Noteworthy Achievements
EPA has been working to identify the risks that nanomaterials pose to human and
the environment. In 2005, EPA launched a collaborative public process to design
and develop the NMSP, and the program was initially implemented in 2008
NMSP encouraged manufacturers to develop and submit information on
nanoscale materials that were already in commerce. While EPA's NMSP did not
provide the results that the Agency was hoping to achieve, it was a positive step in
determining how to effectively gather information about nanomaterials.
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In 2007, EPA published the Nanomaterial White Paper to outline general
nanomaterial issues for the Agency to focus upon. EPA also published its
Nanomaterials Research Strategy in 2009, intended to guide ORD's nanomaterial
research program. EPA has also been active in sharing information with other
international organizations, including the Organization for Economic Cooperation
and Development and the International Organization for Standardization.
Scope and Methodology
We conducted this performance evaluation in accordance with generally accepted
government auditing standards. Those standards require that we plan and perform
the evaluation to obtain sufficient, appropriate evidence to provide a reasonable
basis for our findings and conclusions based on our objectives. We believe that
the evidence obtained provides a reasonable basis for our findings and
conclusions based upon our objectives. We conducted this evaluation from
October 2010 through September 2011.
The scope of this evaluation focused on EPA's responsibilities for oversight,
assessment, and regulation of nanomaterials. As a result, we interviewed all
applicable media offices, including OAR, OCSPP, OECA, Office of Solid Waste
and Emergency Response, and OW. We interviewed the Office of General
Counsel to determine its assessment of EPA's statutory authority to regulate
nanomaterials. We reviewed the American Bar Association analysis of EPA's
authority to regulate nanomaterials under TSCA; FIFRA; the Clean Air Act; the
Clean Water Act; the Comprehensive Environmental Response, Compensation
and Liability Act; and the Resource Conservation and Recovery Act.
We conducted interviews at a wide variety of academic institutions, including the
Smalley Institute for Nanoscale Science and Technology at Rice University, the
University of Michigan Risk Science Center, and the University of Dublin. We
interviewed representatives of nongovernmental organization such as Resources
for the Future, the Environmental Defense Fund, and the Silicon Valley Toxics
Coalition. We also interviewed representatives from the International
Organization for Standardization and the Organization of Economic Cooperation
and Development to better understand global aspects of nanomaterial regulation.
Finally, we reviewed nanomaterial management strategies and regulations from
Canada, the United Kingdom, Australia, and Japan.
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Chapter 2
EPA Does Not Have Sufficient Information and
Processes to Effectively Manage Nanomaterial Risks
At the time of our review, EPA did not have sufficient information or processes to
effectively manage the human health and environmental risks of nanomaterials.
EPA does not have a formal process to coordinate the dissemination and
utilization of nanomaterial information or communicate nanomaterial risks. EPA
is not clearly communicating policy changes and the risks of nanomaterials to
external stakeholders. Also, existing TSCA limitations and resource issues
challenge EPA's ability to assess the risks of nanomaterials using its existing
models. Finally, technological limitations inhibit nanomaterial detection in the
environment, and a reliance on industry data impedes effective nanomaterial
management. If these challenges are not resolved, EPA will continue to lack
assurance that it is making effective nanomaterial management decisions.
Formal Coordination Process Needed to Prioritize Work and Assess
Nanomaterial Risks
EPA does not have an Agency-wide, formal process to disseminate manufacturer
data gathered from TSCA and FIFRA data calls to program offices outside of
OCSPP. Program offices such as ORD need manufacturer data to prioritize work
and assess risks. OCSPP staff stated that both OPP and OPPT have established
relationships with specific individuals in ORD and in the Office of Science Policy
to guide discussions, share information, and review documents specific to
nanomaterials. However, this information sharing is not facilitated by a formal
process; rather, it depends on personal relationships between program office staff.
Information sharing based on personal relationships can be easily disrupted by
transfers, travel, retirements, or other personal factors.
Coordinated sharing of nanomaterial data call information will also be important
if additional regulatory actions become necessary. For instance, OW could use the
information-gathering provisions of the Clean Water Act to collect information
about potential effluent discharges containing nanomaterials. While OW has not
employed this authority, coordination with other offices will be important to
determine whether and when to employ that authority. Additionally, it will be
important for OECA to effectively enforce regulations to ensure that data
submission requirements are followed. OECA officials stated that OECA has
challenges developing enforcement cases for nanomaterials, and must rely heavily
on OCSPP's expertise.
Prior reports have also identified the need for more formal coordination. External
experts have recommended that the Agency convene a standing intra-Agency
group to foster information sharing on nanomaterial science and policy issues. In
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2007, OCSPP convened such a group, but, according to OCSPP staff, it was
disbanded in 2008 after only a few meetings. Because of the growing number of
nanomaterial products entering the marketplace and the anticipated receipt of new
TSCA and FIFRA data following approval of the requested information-gathering
rule changes, it will be increasingly necessary for these program offices to
formally share information and coordinate their efforts.
EPA Should Improve Communication of Nanomaterial Information to
the General Public
Through Federal Register notices, program office Web pages, public
presentations, and meetings, EPA has sought to communicate information related
to nanomaterials and to gather input from stakeholders. However, the Agency as a
whole has not provided a transparent overall message about nanomaterials to the
general public. For some important and/or controversial topics, such as lead
exposures and hydraulic fracturing, the Agency maintains websites that provide
an overall picture of the topic, including safety concerns and the Agency's related
activities. However, there is no such website for nanomaterials. Several program
offices have nanomaterial-related pages, but these pages only provide information
related to that particular program's activities.
Reports published by the Woodrow Wilson International Center for Scholars in
2005 and 20095 cautioned that poor public communication of nanomaterial risks
could threaten the beneficial advancements of the technology and lead to a lack of
public trust in the government to make the right decisions. The 2005 report
concluded that the public wants more information in order to make informed
decisions about nanomaterials.
The Agency should be prepared to communicate to the public any nonconfidential
risk information generated or collected through its FIFRA, TSCA, and research
activities. Because nanomaterials is an emerging issue, it will be important for
EPA to keep the public informed on the benefits and risks, how the public might
be exposed, and what regulatory approach the Agency is taking.
Existing TSCA Limitations Challenge Nanomaterial Management
Nanomaterials will pose additional challenges to EPA's TSCA programs. As
identified in a prior OIG report, the EPA New Chemicals Program is limited by
resources, a lack of information on new chemicals, and its resultant dependence
on modeling to conduct risk assessments. These shortcomings will be exacerbated
by the fact that, according to OPPT representatives, the predictive models they
use for traditional chemicals may not be applicable to nanomaterials. Because
5 Jane Macoubrie, Informed Public Perceptions ofNanotechnology and Trust in Government, 2005; Dan M. Khan
and David Rejeski, Toward a Comprehensive Strategy for Nanotechnology Risk Communication, 2009.
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OPPT relies on self-reported data from industry, it may miss chemical risks that
manufacturers have not disclosed.
In addition, the 2010 U.S. Government Accountability Office report identified
several challenges for the Agency in assessing the risks of nanomaterials using its
existing models. These challenges include the potential for variations in toxicity
corresponding to small differences in the size, shape, surface area, and reactivity
of each individual nanomaterial. As a result, accurately assessing any risks of new
nanomaterials will be difficult for the Agency.
Limitations in Detection and Assessment Inhibit Effective Management
EPA faces technological limitations in its ability to manage nanomaterials. As
stated earlier, technology may not currently exist to detect nanomaterials in the
ambient environment or to remove them if they are found. Thus, the Agency may
not be able to monitor, identify, and remediate nanomaterial contamination if it
were to occur in the natural environment. Traditional toxicological screenings for
nanomaterials are costly and time consuming. According to a senior ORD official,
traditional toxicological studies for chemicals cost approximately $10 million and
endure for 5 years. Although more resources are needed, the Agency is in the
process of testing a new high-throughput screening system called ToxCast,6
which is intended to allow the Agency to more rapidly assess chemicals
(including nanomaterials). Given EPA's resource limitations, potential budget
cuts, and the findings in our prior TSCA evaluation, the costs associated with
current methods to develop toxicological data may not be suited for nanomaterial
data generation.
Conclusions
EPA does not have sufficient information to determine the risks nanomaterials
pose to human health and the environment. Without a formal coordination
process, EPA depends on informal relationships between program office staff to
prioritize nanomaterial research efforts and communicate nanomaterial risks.
Further, industry stakeholders and the public are not receiving an overall message
about policy changes or nanomaterial risks. These management issues, combined
with the challenges of existing TSCA limitations, resource constraints, and
limitations on technical detection and risk assessment, provide significant barriers
to effective nanomaterial management. If EPA does not improve its internal
coordination and develop a clear and consistent stakeholder communication
process, the Agency will not be able to assure that it is effectively managing
nanomaterial risks.
6 EPA launched ToxCast to forecast toxicity using high-throughput screening. This screening examines hundreds of
thousands of chemicals to identify potential effects. In phase 2 of ToxCast, EPA is testing additional chemicals, 50
to 60 of which will be nanoscale materials.
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Recommendation
We recommend that the Assistant Administrator for Chemical Safety and
Pollution Prevention:
1. Develop a process to assure the effective dissemination and coordination
of nanomaterial information across relevant program offices.
Agency Comments and OIG Evaluation
The Agency agreed to our recommendation for a formal process to assure the
effective dissemination and coordination of nanomaterial information across
relevant program offices, and provided a corrective action plan with milestone
dates. The Agency also suggested a revised report title, to which the OIG agreed.
The Agency also provided additional information regarding OCSPP's ongoing
efforts to assess and manage the health and environmental risks of nanomaterials.
It identified numerous activities to demonstrate nanomaterial-related efforts at the
intra-Agency, interagency, and intergovernmental levels. The OIG did note most
of these activities while conducting the evaluation. We added a "Noteworthy
Achievements" section to chapter 1 of the report, which gives a brief overview of
these activities.
EPA did not agree with the OIG finding that the Agency is not clearly
communicating nanomaterial information to the public. However, the OIG still
believes that the Agency, as a whole, should provide a transparent overall
message and could make better use of its website to do so. The OIG believes that
as the Agency collects and gathers more information and takes further actions on
nanomaterials, it will be important to keep the public informed of the benefits,
risks, and potential exposures to nanomaterials, as well as EPA's regulatory
approach. The Agency's detailed response with the OIG's evaluation is provided
in appendix A.
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
POTENTIAL MONETARY
BENEFITS (In $000s)
Rec.
No.
Page
No.
Subject
Status1
Planned
Completion
Action Official	Date
12 Develop a process to assure the effective
dissemination and coordination of nanomaterial
information across relevant program offices.
Assistant Administrator for
Office of Chemical Safety
and Pollution Prevention
07/31/12
Claimed
Amount
Ag reed-To
Amount
1 0 = recommendation is open with agreed-to corrective actions pending
C = recommendation is closed with all agreed-to actions completed
U = recommendation is unresolved with resolution efforts in progress
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Appendix A
Agency Response and OIG Comment
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
X)
MEMORANDUM
OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
SUBJECT: Response to OIG Draft Report No. OPE-FY11-001: "EPA Cannot Effectively
Assess or Manage Nanomaterial Risks"
This memorandum is in response to the Office of Inspector General's (OIG) September 30, 2011,
Draft Report entitled "EPA Cannot Effectively Assess or Manage Nanomaterial Risk." The
Office of Chemical Safety and Pollution Prevention (OCSPP) appreciates the opportunity to
comment on this report.
While OCSPP recognizes the significant research that was done by the OIG's staff to prepare the
Draft Report, the report could be improved by correcting factual errors and by including
additional information on the substantial efforts that OCSPP already is undertaking to address
potential health and environmental risks from the use of nanomaterials. I am highlighting several
key items below, and others are discussed in more detail in the attached technical comments.
First, the title of the report significantly overstates the actual findings set forth in the body of the
report, and for that reason, gives a misleading impression about both EPA's authority over
nanomaterials and the actions the EPA already has been taking in this area. The title should more
accurately read, "EPA Needs to Manage Nanomaterial Risks More Effectively," and we
respectfully request that the title be changed accordingly. Indeed, the Draft Report contains only
a single recommendation, which simply states that the Agency should develop a process to
facilitate the distribution of information regarding nanomaterials across EPA. The current title
gives the inaccurate impression that EPA does not have authority to oversee nanomaterials, and
the limited scope of the recommendation and the findings in the Draft Report do not support the
sweeping declaration in the Draft Report that EPA "cannot effectively... manage nanomaterials."
FROM: Stephen A. Owens
Assistant Administrator
TO:
Arthur A. Elkins, Jr.
Inspector General
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OIG Response: We changed the report title as suggested.
There already is an existing process for coordination between OCSPP, the Office of Research
and Development and other program offices, but OCSPP nevertheless supports the OIG's
recommendation that the Agency establish a more formal process. Please see the attached
Corrective Action Plan for more details on our approach to implementing this recommendation,
which we believe can be accomplished during fiscal year 2012.
Additionally, the Draft Report does not discuss actions that the Agency already is taking to
assess and manage potential health and environmental risks from nanomaterials under both the
Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA). Information describing the Agency's efforts, as discussed below, would help
readers appreciate why the Draft Report's only recommended corrective action is to establish a
more formal process for internal agency coordination.
OIG Response: We understand and acknowledge that the Agency has conducted numerous
activities in the pursuit of effectively managing nanomaterials as described in OCSPP's
response. However, the purpose of this report is to present the result of our evaluation, the
objective of which was "to determine whether EPA is effectively managing the human health
and environmental risks of nanomaterials." As such, we did not find it necessary to include
many of the details OCSPP has described in this response. To provide better context in our
report and credit the Agency for steps taken to date, we have added a "Noteworthy
Achievements" section to chapter 1 of the report. This section gives a brief overview of many
of the activities listed in OCSPP's response.
Further, contrary to the Draft Report's statement that EPA is "not clearly communicating
nanomaterial information to the public," the Agency has taken significant steps to provide
information, seek public input, and engage the public in general on Agency actions to assess and
manage potential health and environmental risks from nanomaterials.
Outlined below are some of the significant steps the Agency has taken regarding its oversight of
nanomaterials and to engage and inform stakeholders and the public on these activities.
OIG Response: The OIG recognizes that EPA offices have made substantial efforts to
communicate with the public through the many avenues described in OCSPP's response. In
chapter 2 of the report, we added a statement recognizing these efforts, and we changed the
section heading to read, "EPA Should Improve Communication of Nanomaterial Information
to the General Public." It remains the OIG's conclusion that the Agency as a whole should
provide a more transparent overall message about nanomaterials, and it could better use its
website to do so. As our report indicates, as the Agency gathers more information and takes
further actions on nanomaterials, it will be important to keep the American people well
informed on nanomaterials' benefits and risks, exposures, and EPA's regulatory approach.
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Intra-agency, Interagency, and Intergovernmental Activities
EPA was an early leader in identifying science and policy issues regarding nanomaterials. In
December 2004, EPA's Science Policy Council created a cross-Agency workgroup charged with
describing key science issues EPA should consider to ensure that society accrues the important
benefits to environmental protection that nanotechnology may offer, as well as to better
understand any potential risks from exposure to nanomaterials in the environment. EPA released
an external peer review draft of the Nanotechnology White Paper in December 2005, and in a
Federal Register notice (70 FR 75812) announced its availability and the opening of a docket for
public comments. After review and consideration of public comments, EPA's Science Policy
Council issued the Nanotechnology White Paper in February 2007. The purpose of the White
Paper was to identify the science issues and needs associated with nanotechnology, to support
related EPA program office needs, and to communicate these nanotechnology science issues to
stakeholders and the public.
OCSPP collaborated closely with the Office of Research and Development (ORD) in the
development of ORD's Nanomaterial Research Strategy. As an example of this collaboration,
OCSPP established a requirement for carbon nanotube premanufacture notices (PMN) that
companies submit a one-gram sample of their PMN material for inclusion in the ToxCast portion
of ORD's research on nanomaterials.
EPA participates in a variety of interagency efforts relating to nanotechnology. For example,
OCSPP has taken a leadership role in addressing nanotechnology and nanomaterials as a member
of the White House Emerging Technologies Interagency Policy Coordination Committee
(ETIPC). EPA also was one of the key agencies most involved in the effort by the
Administration to develop a set of principles for regulation and oversight of nanotechnology
applications. The principles, entitled "Policy Principles for the U.S. Decision-Making
Concerning Regulation and Oversight of Nanotechnology and Nanomaterials," were announced
in June 2011, after an extensive interagency effort in which EPA played a leading role and are
intended to guide the development and implementation of the Administration's regulatory
approach to nanomaterials and nanotechnology. In addition, in partnership with ORD, OCSPP
has participated in the interagency Nanotechnology Environmental and Health Implications
(NEHI) working group, and through the NEHI contributed to both the 2008 and 2011 National
Nanotechnology Initiative (NNI) strategies for environmental, health, and safety research.
OCSPP chairs the steering committee of the multi-stakeholder NanoRelease Project, which is
composed of risk management experts from government, industry, nongovernmental
organizations, and international organizations. This activity is filling important gaps in our
knowledge of exposure to nanomaterials, and is focused on:
•	Providing focus to broad policy debates by working through scenarios under which specific
engineered nanomaterials might be released from products;
•	Examining the full life cycle of products that might act to release nanomaterials;
•	Cataloguing and disseminating published and unpublished data and methods (that meet
minimum criteria) used to evaluate release scenarios;
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•	Developing "state of the science" reports about release measurement for the specific material
types chosen that describe what is known and what research gaps exist; and
•	Enabling improvements, standardization, and widespread use of methods by carrying out
tests using reference nanomaterial-matrix and positive controls in a "round robin" or similar
approach.
Coordination and collaboration with the states has been an important element in EPA's approach
to nanotechnology. For instance, OCSPP's Office of Pollution Prevention and Toxics (OPPT)
interacted closely with the state of California on its carbon nanotube survey activities, including
participating in a stakeholders' workshop convened by California agencies. In addition, OCSPP
and ORD are co-funding a grant to the Environmental Council of the States (ECOS) to support
activities related to emerging chemicals issues, including nanomaterials.
OCSPP also has played a leadership role in international activities related to nanotechnology.
OCSPP chaired the OECD's Working Party on Manufactured Nanomaterials (WPMN) during its
first program of work, and continues to co-lead the United States delegation to the WPMN. A
number of OCSPP staff have contributed, and continue to contribute, to several WPMN
activities.
In September 2009, the Assistant Administrator for OCSPP gave the keynote address at an
international conference on nanotechnology in which he announced EPA's increased focus on
potential health and environmental risks from nanomaterials and the Agency's intention to utilize
its authority under TSCA and FIFRA more fully to assess and manage those risks. In addition,
OCSPP staff led the planning and implementation of a 2010 workshop between U.S. and
European scientists and regulators on nanomaterial science issues, and in 2011 developed a work
plan with the Canadian government to conduct joint activities related to information and
assessment needs for our respective nanotechnology-related regulatory and policy activities.
Activities under TSCA
Under TSCA, EPA is taking significant actions to ensure that new and existing nanoscale
materials are reviewed, that information on potential risks is collected and that any necessary risk
management actions are taken. Since 2005, EPA has received and reviewed over 120 new
chemical notices under TSCA's new chemicals program for a variety of new nanoscale
materials, including carbon nanotubes, fullerenes, quantum dots and nano-metal oxides. The
Agency has taken a number of actions to control and limit exposures to these chemicals,
including limiting the uses of the nanoscale materials, requiring the use of personal protective
equipment, such as impervious gloves and NIOSH approved respirators, limiting environmental
releases, and requiring testing to generate health and environmental effects data.
In 2006, EPA launched a collaborative public process to design and develop a voluntary effort,
the Nanoscale Materials Stewardship Program (NMSP), to help provide a firmer scientific
foundation for regulatory decisions by encouraging the submission and development of
information on nanoscale materials already in commerce. The Agency conducted scientific peer
consultations on risk management practices in October 2006, and on material characterization in
September 2007 to get public and stakeholder input on the NMSP. In July 2007, EPA announced
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the availability for public comment of a Concept Paper that outlined the Agency's initial thinking
on the design and development of the NMSP and conducted a public meeting to obtain additional
input in August 2007. EPA finalized the design and format of the NMSP based on written public
comments, and comments received at the public meeting and scientific peer consultations.
In January 2008, EPA announced the final NMSP and invited interested parties to participate in
the program. Thirty-one companies or associations submitted information to EPA covering over
132 nanoscale materials. EPA placed all public versions of NMSP submissions on its TSCA
nanotechnology webpage. A year later, in January 2009, EPA publicly released a report on the
NMSP reporting the information it had received.
Although the NMSP provided EPA with useful information regarding a limited number of
nanoscale materials in commerce, significant environmental health and safety data gaps remain
on a number of nanomaterials. Accordingly, in light of the limitations of the NMSP and the need
to better understand the existing nanomaterials already in commerce, EPA has begun efforts to
develop new data reporting requirements for nanomaterials under TSCA. EPA's new approach
was forecast by OCSPP's Assistant Administrator in his September 2009 keynote speech,
including the need to address these data gaps.
In January 2008, after providing the public and stakeholders an opportunity to review and
provide comment, EPA released a paper, "TSCA Inventory Status of Nanoscale Substances -
General Approach (2008)," that outlined EPA's thinking regarding whether a nanoscale material
is a "new" or "existing" chemical substance under TSCA. In October 2008, EPA published a
Federal Register notice regarding the TSCA Inventory status of carbon nanotubes which
indicated that EPA considers carbon nanotubes to be new chemical substances under TSCA, and
therefore they are subject to review prior to introduction into the marketplace.
In October 2010, the Agency submitted to the Office of Management and Budget (OMB) for
interagency review a proposed rule under TSCA Section 8(a) to require reporting of certain
information on nanomaterials by industry and a proposed "significant new use rule" (SNUR)
under TSCA §5(a)(2). Under these proposals, certain chemical substances with nanomaterials
not already manufactured would be subject to a SNUR under TSCA §5(a)(2) that would require
submission of a "significant new use notice" (SNUN) to EPA at least 90 days prior to
commencing manufacture of these types of materials. The notice would provide EPA with the
opportunity to evaluate the new use and address any unreasonable risks to human health or the
environment. Data on other chemical substances with nanomaterials already being manufactured
would be required to be reported to EPA under TSCA §8(a). These proposals were developed by
OCSPP after extensive discussions with stakeholders and public outreach.
Outreach as been integral to OPPT's nanotechnology activities. OPPT began its TSCA-related
nanotechnology outreach in 2005, when it convened a public meeting to discuss the regulatory
implications of manufactured nanomaterials. Later that year, OPPT engaged the National
Pollution Prevention and Toxics Advisory Committee (NPPTAC) in dialogue concerning
nanomaterials and TSCA, and later that year held a second public meeting focused on the
NPPTAC's recommendations to EPA. Since that time, on regulatory and policy implications of
nanomaterials for TSCA, OPPT has engaged in numerous outreach activities with many diverse
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stakeholders, ranging from the Transatlantic Consumer Dialogue to the American Chemistry
Council to Personal Care Products Council. In addition, OPPT has briefed many other federal
agencies, congressional staff, and state agencies, as well as interagency and government advisory
bodies such as ECOS, the NEHI, the President's Council of Advisors on Science and
Technology, and the National Academy of Sciences. OPPT also has conducted focused outreach
for specific programmatic activities, such the NMSP and its draft TSCA significant new use and
information-reporting rules. In many of these outreach activities, OPPT and ORD staff have
collaborated and in some cases have given joint presentations, so that communication and
discussion of the Agency's nanotechnology-related TSCA activities are conducted with full
appreciation for the interrelationships between the development of regulatory activities and the
evolving scientific understanding about the health and environmental implications of
nanotechnology.
Activities under FIFRA
The Agency has also undertaken multiple efforts under FIFRA with respect to the use of
nanomaterials in pesticides. These efforts can be described in three broad categories relating to
the development of scientific understanding of risk assessments for nanomaterials in pesticides,
the development of regulatory policies, and outreach to stakeholders.
Scientific Policies. Shortly after issuance of the 2005 draft White Paper, OCSPP's Office of
Pesticide Programs (OPP) assembled an interdisciplinary team of scientists and regulatory
specialists to develop policies and procedures for the assessment and regulation of pesticides
containing nanomaterials. This group participated in intra-agency and interagency activities to
become familiar with the scientific and regulatory issues facing other regulatory programs.
In 2009, OPP sought the advice of its FIFRA Scientific Advisory Panel (SAP) on how to assess
the risk of pesticides containing nanosilver. The SAP is a federal advisory committee that
includes independent external scientist who provide advice on scientific issues arising in the
regulation of pesticides. The SAP advised OPP that nanosilver could have different properties
from ionic or bulk silver and therefore should be separately tested and evaluated.
Regulatory actions. Consistent with recommendations by the Government Accountability Office
(GAO) in its 2010 report, in June 2011 EPA published a Federal Register notice proposing a new
policy on how it will use its authority under FIFRA to oversee and gather information on
nanoscale materials in pesticide products. In that Notice, the Agency proposed to classify any
application for registration of a pesticide product containing nanomaterials as an application for a
"new" active or inert ingredient and described how it could use FIFRA §6(a)(2) or §3(c)(2)(B) to
gain information on what nanoscale materials are in pesticide products. This Notice generated
significant public interest. EPA received 159 public submissions, three of which contained
12,895 letters. The majority of commenters expressed support for EPA's proposed policies.
OCSPP has reviewed the public comments and recently submitted a draft final policy to OMB
for interagency review.
OPP also is addressing individual pesticide products that contain nanomaterials. OPP has
received several applications for registration of new products that incorporate various
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nanomaterials in pesticide products. One of the early applications proposed to register a product
containing nanosilver for use as a materials preservative on textiles. Following the SAP's advice,
OPP developed a draft risk assessment for the pesticide. In 2010 EPA issued its risk assessment
for public comment as part of its proposed conditional registration of the nanosilver pesticide.
This was the first time that EPA had proposed to grant registration of a pesticide that explicitly
contained nanomaterial. The Agency received public comments on the proposed registration
from a broad spectrum of stakeholders, including private citizens and is in the process of making
a final decision on the registration.
In conjunction with its review of this nanosilver pesticide registration application, OPP has been
working to identify pesticides that contain nanomaterials that were not disclosed to EPA during
the registration process. EPA's ability to know which currently registered pesticide actually
contain nanomaterials would be enhanced by finalization of the FIFRA policy discussed above.
OPP has also held numerous pre-submission meetings with potential applicants for the
registration of pesticide products containing nanomaterials. At these meetings, OPP works with
the companies to ensure they understand Agency's registration process and the types of
information and data needed by the Agency to make the required statutory findings to register a
product.
Outreach. OPP has solicited extensive and frequent public comment on its actions relating to
nanomaterials, including at meetings of the Pesticide Program Dialogue Committee (PPDC) (a
committee consisting of members from academia, industry, non-governmental groups, and state
governments); the State FIFRA Issues Research and Evaluation Group (SFIREG); and the Tribal
Pesticide Program Council (TPPC). OPP also given presentations at and participated in
stakeholder forums to discuss its policy and regulatory thinking on nanomaterials, including, for
example, the September 2011 International Biocidal Products Directive Conference, the August
2011 Association of Structural Pest Control Regulatory Officials Conference, the April 2011
CropLife America meeting, the Responsible Industry for a Sound Environment (RISE) 2011
Spring Conference, and the May 2011 American Bar Association SEER Nano Governance
Program Planning Forum. Moreover, EPA presented its draft risk assessment of the nanosilver
pesticide product at multiple national scientific meetings, including the 2010 Society of
Environmental Toxicology and Chemistry annual meeting, the December 2010 Society for Risk
Analysis annual meeting, and the March 2011 American Chemical Society Spring meeting. In
addition, EPA's assessment was presented at the May 2011 Joint Special Meeting of The
Toxicology Forum/Regulatory Governance Initiative: Nanoparticles: Tools for Toxicology.
Factual Errors About EPA's TSCA and FIFRA Authority
Finally, the Draft Report contains several key factual errors that inaccurately characterize EPA's
statutory authority under FIFRA and TSCA. For example, the Agency is responsible for
regulating nanomaterials used in pesticides under FIFRA and in industrial chemicals under
TSCA. However, the Draft Report incorrectly suggests that EPA has jurisdiction over several
other uses for nanomaterials, such as foods and drugs, which are expressly excluded from EPA's
purview. In addition, the Draft Report does not discuss the fact that EPA's authority under TSCA
extends to distribution in commerce, and the use and disposal of nanomaterials, and it fails to
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discuss EPA's TSCA authority for new chemicals. Further, the Draft Report does not make clear
that FIFRA does not authorize the Agency to regulate the manufacturing process for pesticides
containing nanomaterials, and it inaccurately states that that "several nanomaterials have been
found to be effective when used as pesticides." Under FIFRA, EPA has not made any
determinations on the efficacy of nanomaterial products.
These errors are discussed in more detail in the attached technical comments, as are other errors
relating to other aspects of the Agency's efforts on nanomaterials.
OIG Response: In the above comments, OCSPP has expressed concerns over an omission
related to TSCA authority, and the potential for incorrect interpretation of the report language
related to TSCA and FIFRA jurisdiction. The OIG does not view these as "factual errors." To
ensure accurate interpretation of the language in the report, we made changes to the language
regarding TSCA and FIFRA jurisdiction and FIFRA responsibilities in chapter 1. We also
removed the statement "several nanomaterials have been found to be effective when used as
pesticides" to avoid the implication that EPA has made this claim. Additionally, we have
reviewed and incorporated as appropriate several of the suggested edits provided in OCSPP's
detailed "Technical Comments" document.
Conclusion
In sum, EPA has been committed for several years to developing and taking action to ensure the
safe use of nanoscale materials, and to engaging and informing our stakeholders and the public
on these actions. We believe that recognition of the scope and extent of the Agency's activities
regarding nanomaterials, and correction of the factual errors in the Draft Report would put your
report and its recommendation in better context.
Thank you again for the opportunity to comment on this Draft Report. OCSPP looks forward to
working with your office as the report is finalized and the recommendation implemented. If you
have questions, please feel free to contact Janet Weiner of my staff at (202) 564-2309.
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Corrective Action Plan for Report No. OPE-FY11-001
"EPA Cannot Effectively Assess or Manage Nanomaterial Risks"
11/28/11
Recommendation to the Assistant Administrator, Office of Chemical Safety and Pollution
Prevention: Develop a process for dissemination and coordination of nanomaterials information
across relevant program offices.
Specific Recommendation
Corrective Action
Target Date
Develop a process to assure
the effective dissemination
and coordination of
nanomaterials information
across relevant program
offices.
By January 31, 2012, convene
a workgroup consisting of
representatives from all
relevant offices to begin
development of process.
Complete draft document
outlining process.
January 31, 2012
July 31,2012
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Appendix B
Distribution
Office of the Administrator
Deputy Administrator
Acting Assistant Administrator for Chemical Safety and Pollution Prevention
Agency Follow-Up Coordinator
Agency Follow-Up Official (the CFO)
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for External Affairs and Environmental Education
Director, Office of Children's Health Protection and Environmental Education
Audit Follow-Up Coordinator, Office of Chemical Safety and Pollution Prevention
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