[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Proposed Rules]
[Pages 35383-35395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14943]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Chapter I
[EPA-HQ-OPP-2010-0197; FRL-8877-9]
RIN 2070-ZA11
Pesticides; Policies Concerning Products Containing Nanoscale
Materials; Opportunity for Public Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed policy statement.
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SUMMARY: EPA seeks comment on several possible approaches for obtaining
information about what nanoscale materials are present in registered
pesticide products. Under one approach, EPA would use section 6(a)(2)
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to
obtain information regarding what nanoscale material is present in a
registered pesticide product and its potential effects on humans or the
environment. If EPA adopts this approach, 40 CFR 152.50(f)(3) would
also require the inclusion of such information with any application for
registration of a pesticide product that contains a nanoscale material.
Under an alternative approach, EPA would obtain such information using
Data Call-In notices (DCIs) under FIFRA section 3(c)(2)(B). If EPA
adopts this alternate approach, EPA would also
[[Page 35384]]
need to require the inclusion of this information with any application
for registration of a pesticide product that contains a nanoscale
material. It is EPA's view that FIFRA section 6(a)(2) is the most
efficient and expedient administrative approach to obtaining
information about nanoscale materials in pesticides and EPA would
prefer to use this approach. EPA is also proposing a new approach for
how EPA will determine on a case-by-case basis whether a nanoscale
active or inert ingredient is a ``new'' active or inert ingredient for
purposes of FIFRA and the Pesticide Registration Improvement Act
(PRIA), even when an identical, non-nanoscale form of the nanoscale
ingredient is already registered.
DATES: Comments must be received on or before July 18, 2011.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0197, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0197. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Jed Costanza, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 347-0204; fax number: (703) 308-8005; e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. What is this document about?
This document describes several possible approaches for obtaining
certain additional information on the composition of pesticide
products. The notice focuses particularly on information about what
nanoscale materials are present in registered pesticide products. In
connection with this document, EPA describes ``nanoscale material'' as
an active or inert ingredient and any component parts thereof
intentionally produced to have at least one dimension that measures
between approximately 1 and 100 nanometers (nm).
Under one approach, EPA would use section 6(a)(2) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) to obtain
information regarding what nanoscale material is present in a
registered pesticide product and its potential effects on humans or the
environment. If EPA adopts this approach, 40 CFR 152.50(f)(3) would
also require the inclusion of such information with any application for
registration of a pesticide product that contains a nanoscale material.
Under an alternative approach, EPA would obtain such information
using Data Call-In notices (DCIs) under FIFRA section 3(c)(2)(B). If
EPA adopts this alternate approach, EPA would also need to require the
inclusion of this information with any application for registration of
a pesticide product that contains a nanoscale material. EPA is
reviewing whether this could be done under existing regulations or
whether EPA would need to amend existing regulations to clarify that
the information is required with any application for registration.
It is EPA's view that FIFRA section 6(a)(2) is the most efficient
and expedient administrative approach to obtaining information about
nanoscale materials in pesticides and EPA would prefer to use this
approach.
This document also proposes a new approach for how EPA will
determine on a case-by-case basis whether a nanoscale active or inert
ingredient is a ``new'' active or inert ingredient for purposes of
FIFRA and the Pesticide Registration Improvement Act (PRIA), even when
an identical, non-nanoscale form of the nanoscale ingredient is already
registered.
After considering any public comments on the use of FIFRA section
6(a)(2) or DCIs under FIFRA section 3(c)(2)(B), as well as public
comments submitted in response to other questions posed in this
document, EPA plans to issue a subsequent document in the Federal
Register announcing its approach to gather this information. EPA is
also asking for specific input on the proposed approach for determining
whether a nanoscale material is ``new'' under FIFRA and PRIA.
B. Does this action apply to me?
This action is directed to those persons who manufacture,
distribute, sell, apply, or regulate pesticide products, including
agricultural, commercial, and residential products (NAICS codes 32532
and 32561). This listing is not intended to be exhaustive, but rather
provides a guide for readers regarding entities likely to be affected
by this action. Other types of entities not
[[Page 35385]]
listed in this unit could also be affected. The North American
Industrial Classification System (NAICS) codes have been provided to
assist you and others in determining whether this action might apply to
certain entities. If you have any questions regarding the applicability
of this action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.
C. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Applicable Statutory and Regulatory Requirements
As a general matter, pesticides may not be sold or distributed in
the United States unless they are registered with EPA. FIFRA section
3(a) (7 U.S.C. 136a(a)). In order to obtain a pesticide registration,
an applicant must provide EPA with data (or cite existing data)
demonstrating that the proposed registration complies with the
requirement for registration. FIFRA section 3(c)(1)(F) (7 U.S.C.
136a(c)(1)(F)). FIFRA contains two provisions under which EPA may
register pesticides: Section 3(c)(5) for ``unconditional'' registration
and section 3(c)(7) for ``conditional'' registration (7 U.S.C.
136a(c)(5) and 7 U.S.C. 136a(c)(7)). Importantly, EPA must make
statutorily required findings for each and every pesticide product for
which registration is sought, regardless of whether another pesticide
product with the same or similar composition and use patterns is
already registered.
The standard for determining whether an application should be
granted unconditionally is found in FIFRA section 3(c)(5). This section
provides that, in order to grant a registration, EPA must find that a
product's composition warrants the proposed claims for it; that the
product's labeling and other material required to be submitted comply
with FIFRA; that the product will perform its intended function without
causing unreasonable adverse effects on the environment; and that, when
used in accordance with widespread and commonly recognized practice,
the product will not cause unreasonable adverse effects on the
environment.
FIFRA defines ``unreasonable adverse effects on the environment''
as including ``any unreasonable risk to man or the environment, taking
into account the economic, social, and environmental costs and benefits
of the use of any pesticide.'' FIFRA section 2(bb) (7 U.S.C. 136(bb)).
Thus, a critical aspect of determining whether or not a pesticide
product should be granted a registration is an evaluation of whether
the benefits associated with the use of a pesticide outweigh the risks
associated with such use. The burden of demonstrating that a product
meets the standards for registration rests at all times on the
registrant or applicant for registration. See, e.g., Industrial Union
Dept. v. American Petroleum Institute, 448 U.S. 607, 653 n. 61 (1980);
Environmental Defense Fund v. EPA, 510 F.2d 1292, 1297, 1302 (DC Cir.
1975).
The Agency has promulgated regulations in 40 CFR parts 158 and 161
which identify the types of data EPA expects an applicant to provide to
support an application for registration of a pesticide product. The
Agency requires a wide variety of studies in order to evaluate whether
a pesticide will cause unreasonable adverse effects on the environment.
These required studies include both toxicity tests and data to
characterize exposure to a pesticide, including extensive information
on a product's composition, and its fate in the environment and within
the human body. For certain pesticides EPA also requires data on
product efficacy.
If an applicant cannot provide necessary data for EPA to make the
determinations required to register a product unconditionally under
FIFRA section 3(c)(5), EPA may still be able to register the product
``conditionally'' under FIFRA section 3(c)(7). FIFRA section 3(c)(7)
authorizes EPA to register a pesticide product on the condition that
the applicant provides additional data necessary to support a finding
that the product meets the statutory standards in FIFRA section
3(c)(5). FIFRA section 3(c)(7) authorizes conditional registration in
three circumstances. First, the Agency may conditionally register a
product if EPA determines, among other things, that the product is
identical or substantially similar to a currently registered pesticide
or differs only in ways that would not significantly increase the risk
of unreasonable adverse effects on the environment, and that approving
the registration in the manner proposed would not significantly
increase the risk of any unreasonable adverse effect on the
environment. FIFRA section 3(c)(7)(A) (7 U.S.C. 136a(c)(7)(A)).
Products approved under this authority are commonly called ``me-too
registrations.'' Second, EPA may register a pesticide for an additional
use, if the applicant provides data to evaluate the safety of the new
use, and use of the product would not significantly increase the risk
of unreasonable adverse effects on the environment compared to products
already registered. FIFRA section 3(c)(7)(B) (7 U.S.C. 136a(c)(7)(B)).
These product approvals are referred to as ``new use'' registrations.
Finally, EPA may conditionally register a pesticide product that
contains an active ingredient not present in any currently registered
pesticide product, if the Administrator determines that:
1. The applicant has provided all data necessary to evaluate the
safety of the pesticide, with the exception of any data which are
lacking because the applicant has not had enough time to generate
the data since learning of the requirement;
2. Use of the pesticide during the time period needed to develop
the additional data will not cause unreasonable adverse effects on
the environment; and
[[Page 35386]]
3. Use of the pesticide is in the public interest.
FIFRA section 3(c)(7)(C) (7 U.S.C. 136a(c)(7)(C)).
As with applications for unconditional registrations, applicants
for conditional registration bear the burden at all times of
demonstrating that the statutory standards are met.
The Agency's interest in data to evaluate the risks and benefits of
a pesticide does not necessarily end once EPA has registered a
pesticide product. Accordingly, other provisions of FIFRA allow the
Agency to require pesticide registrants to develop and submit
information the Agency believes it needs in order to maintain the
registration of pesticide products.
A. DCI
Under FIFRA section 3(c)(2)(B), EPA may send a DCI notice to a
registrant requiring the registrant to provide additional data or other
information, which the registrant may need to generate or compile.
Specifically, ``if the Administrator determines that additional data
are required to maintain in effect an existing registration of a
pesticide, the Administrator shall notify all existing registrants of
the pesticide to which the determination relates and provide a list of
such registrants to any interested person.'' Failure to respond to the
DCI can serve as the basis for suspending the registration of the
product, thereby making it unlawful for the registrant to sell or
distribute the pesticide.
Generally, EPA's determination that additional data are needed is
contemplated to occur for one of the following five reasons:
1. The Re-registration Program. Section 4 of FIFRA requires EPA to
re-assess the health and safety data for all pesticide active
ingredients registered before November 1, 1984, to determine whether
these ``older'' pesticides meet the criteria for registration that
would be expected of a pesticide being registered today for the first
time. Section 4 of FIFRA directs EPA to use section 3(c)(2)(B)
authority to obtain the required data.
2. The Registration Review Program. Section 3(g) of FIFRA contains
provisions to help achieve the goal of reviewing each pesticide every
15 years to assure that the pesticide continues to pose no risk of
unreasonable adverse effects on human health or the environment.
Section 3(g) instructs EPA to use the section 3(c)(2)(B) authority to
obtain the required data.
3. Anticipated Residue/Percent Crop Treated Information. Under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), before
a pesticide may be used on food or feed crops, the Agency must
establish a tolerance for the pesticide residues on that crop or
establish an exemption from the requirement to have a tolerance.
Section 408(b)(2)(E) and (F) of FFDCA authorize the use of anticipated
or actual residue (AR) data and percent crop treated (PCT) data to
establish, modify, maintain, or revoke a tolerance for a pesticide.
FFDCA requires that if AR data are used, data must be reviewed 5 years
after a tolerance is initially established.
4. The Special Review Program. EPA may conduct a Special Review if
EPA believes that a pesticide poses risks of unreasonable adverse
effects on human health or the environment. In the Special Review
Program, EPA focuses on specific hazards or uses of a pesticide.
Special Reviews are not intended to be comprehensive evaluations of the
pesticide; instead the Special Review DCIs are to address the specific
hazard or exposure concerns that are at issue.
5. Enforcement and Unanticipated Circumstances. The need for a DCI
may arise from the discovery of deficiencies in previously submitted
data, or from the discovery of specific attributes of the pesticide or
its ingredients. This may lead the Agency to determine that additional
information is necessary to reassess whether the pesticide will cause
unreasonable adverse effects on the environment. This type of DCI is
needed because the concern and therefore the need for data arise not
from a mandated review program like Re-registration or Registration
Review described above, but from unanticipated circumstances. Section
3(c)(2)(B) of FIFRA provides a means of obtaining any needed data.
B. FIFRA Section 6(a)(2)
FIFRA section 6(a)(2) provides that registrants must inform the
Agency of relevant information relating to their products, even though
it was not specifically requested by EPA. Specifically, FIFRA section
6(a)(2) requires that, ``[i]f at any time after the registration of a
pesticide the registrant has additional factual information regarding
unreasonable adverse effects on the environment of the pesticide, the
registrant shall submit such information to the Administrator.'' (7
U.S.C. 136d(a)(2)). For over 30 years, EPA has interpreted this
provision expansively to include not only information relating directly
to adverse effects caused by pesticides, but also to other types of
information and studies that EPA would typically use in assessing
whether a pesticide meets the statutory standard for registration
(i.e., the ``unreasonable adverse effects on the environment'' risk/
benefit standard). See 43 FR 37611 (August 23, 1978).
In 1997, EPA promulgated a final rule at 40 CFR part 159, subpart D
in the Federal Register issue of September 19, 1997 (62 FR 49370) (FRL-
5739-1), setting forth EPA's interpretation and enforcement policy
regarding FIFRA section 6(a)(2). The rule explains, among other things,
what information EPA regards as ``additional'' and ``factual,'' as well
as how quickly and to whom such information must be reported. The
regulation specifies many kinds of information, from varied scientific
disciplines, that EPA requires registrants to submit pursuant to FIFRA
section 6(a)(2). The types of information reflect the variety of
scientific data used by EPA in making the statutorily required
determinations--whether pesticides cause unreasonable adverse effects
on the environment. Thus, for example, the regulations generally
require registrants to report studies indicating that a pesticide
causes new or a higher incidence of toxic effects than previously
identified (see 40 CFR 159.165) and to report incidents involving
injury to humans, pets, or wildlife resulting from exposure to a
pesticide (40 CFR 159.184). But, EPA uses other types of information
that do not directly demonstrate adverse effects in its risk
assessments, and new factual information of this kind is also
reportable under the regulation. For example, registrants must report
studies that identify new metabolites, degradates, impurities, or
contaminants of pesticides (40 CFR 159.179); certain information on the
detection of pesticide residues in water, food, and feed (40 CFR
159.178); and new studies of human exposure (40 CFR 159.170). In sum,
EPA's regulation requires reporting of many types of information
relevant to EPA's assessment of the safety of a pesticide product--in
the words of section 6(a)(2) ``information regarding unreasonable
adverse effects on the environment of the pesticide''--not merely
information that directly concerns adverse effects.
In promulgating that regulation, however, EPA also recognized it
was impossible to establish rules addressing every type of factual
information that might become relevant in the future to judging whether
a registered pesticide product continued to meet the FIFRA statutory
standards. Accordingly, 40 CFR 159.195(a) provides:
[[Page 35387]]
The registrant shall submit to the Administrator information
other than that described in Sec. Sec. 159.165 through 159.188 if
the registrant knows, or reasonably should know, that if the
information should prove to be correct, EPA might regard the
information alone or in conjunction with other information about the
pesticide as raising concerns about the continued registration of a
product or about the appropriate terms and conditions of
registration of a product.
In addition, 40 CFR 159.195(c) provides that:
[t]he registrant shall submit * * * information other than that
described in Sec. Sec. 159.165 through 159.188 if the registrant
has been informed by EPA that such additional information has the
potential to raise questions about the continued registration of a
product or about the appropriate terms and conditions of
registration of a product.
Thus, once the Agency has informed registrants that EPA considers a
particular type of information relevant to determining whether a
pesticide has the potential to cause unreasonable adverse effects on
the environment, that type of information becomes reportable under
FIFRA section 6(a)(2).
Finally, EPA promulgated a regulation at 40 CFR part 152 addressing
the submission of applications for registration (53 FR 15952, May 4,
1988) (FRL-3266-9b). That rule specifies, among other things, certain
types of information that an application for registration of a
pesticide product must contain. The rule provides that the applicant
must ``furnish with his application any factual information of which he
is aware regarding unreasonable adverse effects of the pesticide on man
or the environment, which would be required to be reported under FIFRA
section 6(a)(2), if the product were registered.'' 40 CFR 152.50(f)(3).
Registrants' compliance with FIFRA section 6(a)(2) and EPA's
implementing regulations in 40 CFR parts 152 and 159 ensures that EPA
has access to any additional factual information that could be
important for determining whether a previous Agency decision to
register a pesticide remains a correct one, and whether a registered
pesticide can in fact be used without posing unreasonable adverse
effects to human health and the environment. This provision of FIFRA
recognizes that registrants may come into the possession of important
new information that was not anticipated by the Agency or of
information the importance of which was not previously known, and that
in the absence of registrants submitting such information, EPA might
well remain unaware of the information. Failures to report required
information, or delays in reporting, are regarded by EPA as violations
of FIFRA section 6(a)(2), which in turn makes them actionable under
FIFRA sections 12(a)(2)(B)(ii) and 12(a)(2)(N) (7 U.S.C.
136j(a)(2)(B)(ii) and 7 U.S.C. 136j(a)(2)(N)).
III. EPA's Interest in Nanoscale Materials as Pesticide Ingredients
EPA believes that certain information concerning pesticide
ingredients, which applicants and registrants have not routinely
provided previously, is relevant to the Agency's statutory obligation
to determine whether the registration of a pesticide may cause
unreasonable adverse effects on the environment. For the reasons
discussed below, EPA is particularly interested in nanoscale materials
in this context. Accordingly, EPA is considering how to collect
information about what nanoscale materials are in pesticide products
and is therefore soliciting public comment on two possible approaches.
It is important to first clarify how the term ``nanoscale material'' is
being used for purposes of this document.
A. Nanoscale Material
To date, EPA has not developed formal definitions for the terms
``nanotechnology'' or ``nanoscale materials'' or any similar terms for
regulatory purposes under any statute administered by the Agency. Broad
definitions for the terms ``nanotechnology'' or ``nanoscale materials''
and discussions of nanotechnology generally reflect the same common
elements, namely:
1. The material's particle size measures typically between
approximately 1 and 100 nm in at least one dimension;
2. The material exhibits unique or novel properties compared to
larger particles of the same material; and
3. Rather than occurring naturally, the material has been
manufactured or engineered at the nanoscale to take advantage of these
unique properties. See, for example, the definition from the National
Nanotechnology Initiative at: http://www.nano.gov/html/facts/whatIsNano.html.
These elements do not readily work in a regulatory context because
of the high degree of subjectivity involved with interpreting such
phrases as ``unique or novel properties'' or ``manufactured or
engineered to take advantage of these properties.'' Moreover, the
contribution of these subjective elements to risk has not been
established.
Instead, OPP will focus on more objective criteria in describing
when information about a ``nanoscale material'' in a pesticide product
may be relevant to determining whether the product has an unreasonable
adverse environmental effect. Specifically, such information may be
relevant in this context when the active or inert ingredient and any
component parts thereof is intentionally produced to have at least one
dimension that measures between approximately 1 and 100 nanometers,
regardless of the aggregation or agglomeration state of the final
material.
In determining whether an ingredient meets this description, EPA
may review particle size data and, among other things, the
manufacturing process to determine whether it employs processes
specifically to create or enhance the proportion of nanoscale materials
in the product, as compared with other processes used to produce
similar products. The Agency generally expects that these ingredients
may comprise, but are not limited to, metal-based (e.g., silver) and
carbon-based (e.g., carbon nanotubes) nanoscale materials. The Agency
does not, however, intend this description to cover biological
materials (e.g., DNA, RNA, proteins) or materials in their natural
state (e.g., clays). To the extent that the application of this
description to a particular product or ingredient is unclear, EPA would
review information provided by a registrant or applicant concerning the
composition of the pesticide product and to provide an Agency view on
whether the product did (or did not) contain a nanoscale material for
purposes of this policy.
B. Potential of Nanoscale Materials To Affect Human Health and the
Environment
There is a growing body of scientific evidence showing that
differences can exist between nanoscale material(s) and their non-
nanoscale counterpart(s) (Ref. 1). Nanoscale materials may have
different or enhanced properties--for example, electrical, chemical,
magnetic, mechanical, thermal, or optical properties--or features, such
as improved hardness or strength, that are highly desirable for
applications in commercial, medical, military, and environmental
sectors (Ref. 2). These properties are a direct consequence of small
size, which results in a larger surface area per unit of volume and/or
quantum effects that occur at the nanometer scale (i.e., 1 x 0-9
meters). Small size itself is also a desirable property of nanoscale
materials that is exploited for miniaturization of applications/
processes and/or
[[Page 35388]]
stabilization or delivery of payloads to diverse environments or
incorporation into diverse products.
Nanoscale materials have a range of potentially beneficial public
and commercial applications, including medicine and public health,
clean energy through more efficient solar panels, pollution reduction
and environmental cleanup, and improved products such as stronger,
lighter, and more durable or conductive materials. These benefits arise
from the distinctive properties of nanoscale materials, in that they
are potentially more interactive or durable than other chemicals as a
result of their size and composition. EPA sees the emergence of
nanoscale materials as offering potential benefits for society in many
different fields, including pest control products. The use of nanoscale
materials in pesticide products and treated articles may allow for more
effective targeting of pests, use of smaller quantities of a pesticide,
and minimizing the frequency of spray-applied surface disinfection.
These could contribute to improved human and environmental safety and
could lower pest control costs. For example, as a materials
preservative, nanosilver should maintain its efficacy longer and
require smaller quantities than other silver preservatives due to an
expected gradual and controlled release of silver as opposed to the
rapid release of for example, silver from a zeolite structure or the
immediate dissolution of a silver salt. Therefore EPA seeks to
encourage innovative work in developing nanoscale materials to realize
these benefits.
However, a number of organizations have considered whether the
small size of nanoscale materials or the unique or enhanced properties
of nanoscale materials may, under specific conditions, pose new or
increased hazards to humans and the environment. Government, academic,
and private sector scientists in multiple countries are performing
research into the human health effects of diverse nanoscale materials,
resulting in a substantial and rapidly growing body of scientific
evidence. Recently, governmental and expert peer review organizations
have reviewed and summarized this evidence and offered views about the
implications of this evidence for environmental and human health and
safety.
For instance, in 2009, the National Institute of Occupational
Safety and Health (NIOSH) issued a report, ``Approaches to Safe
Nanotechnology: Managing the Health and Safety Concerns Associated with
Engineered Nanomaterials,'' which summarized the available scientific
information about nanoscale materials and identified the following
potential health and safety properties:
Nanomaterials have the greatest potential to enter the
body through the respiratory system if they are airborne and in the
form of respirable-sized particles (nanoparticles). They may also
come into contact with the skin or be ingested.
Based on results from human and animal studies,
airborne nanoparticles can be inhaled and deposit in the respiratory
tract; and based on animal studies, nanoparticles can enter the
bloodstream, and translocate to other organs.
Experimental studies in rats have shown that equivalent
mass doses of insoluble incidental nanoparticles are more potent
than large particles of similar composition in causing pulmonary
inflammation and lung tumors. Results from in vitro cell culture
studies with similar materials are generally supportive of the
biological responses observed in animals.
Experimental studies in animals, cell cultures, and
cell-free systems have shown that changes in the chemical
composition, crystal structure, and size of particles can influence
their oxidant generation properties and cytotoxicity.
Studies in workers exposed to aerosols of some
manufactured or incidental microscopic (fine) and nanoscale
(ultrafine) particles have reported adverse lung effects including
lung function decrements and obstructive and fibrotic lung diseases.
The implications of these studies to engineered nanoparticles, which
may have different particle properties, are uncertain.
Some nanomaterials may initiate catalytic reactions
depending on their composition and structure that would not
otherwise be anticipated based on their chemical composition. (Ref.
3).
Earlier the same year, the Scientific Committee on Emerging and
Newly Identified Health Risks (SCENIHR), an independent scientific
committee advising the European Commission's Health and Consumer
Directorate, issued a report, ``Risk assessment of products of
nanotechnologies.'' The SCENIHR report identified properties similar to
those identified in the NIOSH report:
Some specific hazards, discussed in the context of risk for
human health, have been identified. These include the possibility of
some nanoparticles to induce protein fibrillation, the possible
pathological effects caused by specific types of carbon nanotubes,
the induction of genotoxicity, and size effects in terms of
biodistribution.
and:
For some nanomaterials, toxic effects on environmental organisms
have been demonstrated, as well as the potential to transfer across
environmental species, indicating a potential for bioaccumulation in
species at the end of that part of the food chain.
(Ref. 4).
In another recent survey of scientific research on nanoscale
materials, the authors reported:
Many studies have examined the pro-inflammatory effects of
manufactured NPs [nanoparticles], on the basis that their ability to
cause inflammation is a major predictor of potential hazard in such
particles. The first important finding was that NPs have a more
pronounced effect on inflammation, cell damage and cell stimulation
than an equal mass of particles of the same material of greater size
[* * *]. This appears to hold true for materials as varied as carbon
black, titanium dioxide, various metals and polystyrene [* * *].
Surface area is the metric driving the pro-inflammatory effects and
this is evident both in vitro [* * *] and in vivo [* * *], particles
of various sizes producing inflammatory effects that are directly
related to the surface area dose.
(Ref. 5 [reference numbers in the original were omitted]).
Other reports in the scientific literature have indicated that some
nanoscale materials may cross the placental barrier (Ref. 6) or
translocate to diverse organs following oral exposure (Ref. 7). Once in
these diverse sites and organs, the large surface area of nanoscale
materials may facilitate increased reactivity and/or an inflammatory
response, resulting in toxic effects.
Two recent literature surveys describe a broad range of effects in
non-mammalian species following exposure to nanoscale materials (Refs.
8 and 9). These include, for example, increased ventilation rates,
mucus production, and pathologies, and related alteration of enzyme
activities and indicators of oxidative stress in rainbow trout,
Oncorhyncus mykiss (Refs. 10 and 11), and ingestion and accumulation of
nanoscale material in the digestive tract, as well as mortality,
increased heart rates, and reduced fecundity in Daphnia magna (Refs.
12, 13, and 14). Translocation of nano-scale materials from gill and
gut surface to blood and other organs in exposed Medaka, Oryzius
latipes, has also been reported (Ref. 15) and carbon nanotubes,
although unable to cross the egg surface, have been shown to delay
hatching in zebrafish, Danio rerio (Ref. 16). A recent review of lethal
effects and concentrations determined for a wide variety of species
showed that some nanoscale materials, including nano-titanium, nano-
zinc oxide, nano-silver, nano-copper oxide, C60, and single- and multi-
walled carbon nanotubes, would be classified as harmful to extremely
toxic to non-mammalian species (Ref. 17).
While the reports and articles cited previously have focused
primarily on
[[Page 35389]]
differences between nanoscale material and conventionally sized
material of the same substances, EPA has also consulted with the FIFRA
Scientific Advisory Panel (SAP) on the extent to which different types
of nanoscale materials may display different properties. (The SAP is a
Federal advisory committee consisting of external, independent, expert,
scientific peer reviewers who provide advice to EPA on scientific
issues involved in the regulation of pesticides.) In response to EPA
questions on how size and other properties of nanoscale materials
potentially affect risk and how to assess such risks, the SAP said:
``Existing data clearly indicate that many properties of particles
change with size, including rate of release of ionic forms of metal,
reactivity or catalytic efficiency, Plasmon resonance, and quantum
effects. * * * The effect of particle size on biological responses to
particle exposure is less well defined.'' (Ref. 18). The SAP also noted
that ``[o]ther physicochemical properties, such as shape, charge and
surface coating, are also likely to impact biological response and
environmental fate [of nanoscale materials]. * * * The lack of a clear
understanding of how particle size and other physical properties affect
hazard profiles led most Panel members to be unsupportive of bridging
among silver-based materials with different properties.'' (Ref. 18).
It is important to emphasize that, while the conclusions described
previously apply to the specific material(s) and or context in which
the study was conducted, any individual type of nanoscale material may
not display all or even any of the characteristics observed and
reported for other nanoscale materials. In other words, some nanoscale
materials may have properties which, for purposes of assessing the risk
of a pesticide, are essentially identical to larger sized materials (or
particles) of the same substance. Furthermore, nanoscale materials may
also have properties that make them less risky, or more beneficial in
some other way, than larger sized materials (or particles) of the same
substance. So, it appears increasingly likely that there are few, if
any, universal ``nanoscale'' effects, and the distinctive effects seen
at nanoscale are specific to the properties of each material type under
specific exposure scenarios. Thus, EPA does not regard the fact that an
ingredient meets our description of a nanoscale material as evidence
that a pesticide containing the ingredient would cause unreasonable
adverse effects on the environment and thus would no longer meet the
statutory standards for registration. Rather, the presence of a
nanoscale material in a pesticide is grounds for EPA to consider the
possible need for data to characterize the potential of the ingredient
to pose risks. However, the registration status of a product would not
change merely as a result of providing information to EPA about the
presence of a previously-unreported nanoscale material. If, based on a
science based assessment of the risks of the specific pesticide
ingredients involved, EPA were to determine that the pesticide no
longer met the criteria for registration, or that some change was
needed in the conditions of use, EPA would conduct a separate action to
notify the manufacturer of that determination, consistent with current
FIFRA regulations.
Finally, scientifically speaking, there currently is no bright line
with respect to a size below (or above) which nanoscale materials do
(or do not) exhibit properties that might be of interest in assessing
whether a pesticide product has the potential to cause unreasonable
adverse effects on the environment. Therefore, the precise size range
in nanometers addressed by the policies proposed in this document might
be revised in the future as new information becomes available.
C. Nanoscale Materials and Pesticides
The Agency has information indicating that the use of
nanotechnology has started to expand into pesticide products, as it
already has in many other fields. For instance, a number of companies
have contacted EPA expressing an interest in obtaining registrations
for pesticide products containing ingredients identified as nanosilver
or nanosilver composite structures (jointly referred to as
``nanosilver''), and several companies have submitted applications to
register pesticides containing nanosilver. In addition, EPA now has
information suggesting that there are other pesticide products
currently registered and in the marketplace that contain nanosilver as
an active ingredient.
In order for EPA to fulfill its responsibilities to regulate
pesticides under FIFRA, it needs to determine whether pesticidal
products meet the statutory standards for registration. As summarized
previously, EPA believes that what intentionally produced nanoscale
materials are in a pesticide product, whether as an active or inert
ingredient, is relevant to that determination. Accordingly, EPA is
considering how to collect information not only about what nanoscale
materials are in pesticide products, but also other information that
may be relevant to the assessment of the potential of such pesticide
products to cause unreasonable adverse effects on the environment. Such
information may be important for EPA to determine whether EPA should
continue the registration of a product, or amend, as appropriate, the
terms and conditions of registration of a product. EPA is therefore
soliciting public comment on two possible approaches for obtaining this
information, as discussed in this document.
IV. Information Relevant To Assessing the Presence of Nanoscale
Materials in a Pesticide
In light of the foregoing and in consideration of the potential for
nanoscale material to cause different effects and to behave differently
in the environment and within organisms from larger particles of the
same substance, as well as from nanoscale materials with different
characteristics (see Unit III.B.), EPA believes that any of the
following types of information are relevant to assessing the potential
of a pesticide to cause unreasonable adverse effects on the
environment:
Any information concerning what nanoscale materials are
present in pesticides, whether as an active ingredient or as an inert
ingredient;
For any pesticide product that contains nanoscale
material, whether active or inert, any existing information that
characterizes the size and size distribution of the nanoscale material
as measured in nanometers;
For any pesticide product that contains nanoscale
materials, whether active or inert, any existing information that
describes the manufacturing process used to produce the nanoscale
material in whatever size range it is produced;
For any pesticide product that contains nanoscale
materials, whether active or inert, and that also is or will be used
for an end-use formulation that contain(s) a composite (e.g., the
active ingredient is a matrix complex comprised of the nanoscale
material(s) in combination with a carrier, such as silica or sulfur),
any existing information that characterizes the size and size
distribution of the composite; and
For any pesticide product that contains nanoscale
materials, whether active or inert, any existing information that shows
adverse effects at any level of exposure to the nanoscale material on
humans or nontarget species, and/or that shows the levels or nature
(e.g. routes, frequency, or life stage) of
[[Page 35390]]
potential human and environmental exposure.
Importantly, the foregoing is not intended to be an exclusive list.
To the extent that a registrant has a pesticide product that contains a
nanoscale material, and in addition has any other existing information
not captured in the previous list that pertains to, concerns, or
otherwise relates to the nanoscale material and has the potential to
raise questions about the continued registration of a product or the
appropriate terms and conditions of a product registration, EPA is also
considering whether this too should be submitted to the Agency.
EPA will review information submitted concerning what nanoscale
materials are present, including any existing information not
previously provided to the Agency on size and size distribution,
manufacturing process, and adverse effects. EPA will use this and
product use information to determine if it raises any issues, not
previously considered, regarding the product's potential to cause
unreasonable adverse effects on the environment. In some cases, EPA may
determine that additional information is needed to assess such
potential; in this case, additional data may be required including data
on physical and chemical properties, rate of nanoscale material
release, and acute, subchronic, and chronic toxicity to human and
ecological receptors.
V. Reporting the Presence of Nanoscale Materials in Pesticide Products
As discussed in Units III. and IV. of this document, EPA believes
that information about what nanoscale materials are in pesticide
products is important to its assessment of whether pesticides meet the
statutory standard for registration. EPA may require such information
under either FIFRA section 6(a)(2) or section 3(c)(2)(B). The Agency
believes that announcing the applicability of FIFRA section 6(a)(2) to
this type of information would be the most efficient and expedient
administrative approach to obtaining existing information about
nanoscale materials in pesticides, in which case any registrants with
this type of information would be required to report it to EPA. The
Agency is considering, however, an alternative approach under which it
would issue DCIs under FIFRA section 3(c)(2)(B) to obtain this
information, in which case registrants that received the DCI would be
required to respond. This unit of the document discusses the two
possible approaches and related procedures for obtaining information
concerning nanoscale materials in pesticides.
A. FIFRA Section 6(a)(2)
As mentioned previously, FIFRA section 6(a)(2) and implementing
regulations in 40 CFR part 159 require pesticide registrants to report
certain information if that information:
1. Is additional;
2. Is factual; and
3. Regards unreasonable adverse effects on the environment of the
pesticide.
Per 40 CFR 159.195, this includes information that, if correct, a
registrant knows, or reasonably should know, would be regarded by EPA,
either alone or in conjunction with other information about the
pesticide, as raising concerns about the continued registration of a
product or about the appropriate terms and conditions of registration
of a product.
Announcing the applicability of FIFRA section 6(a)(2) to
information about nanoscale materials in pesticides would not mean that
EPA is expanding its interpretation of FIFRA section 6(a)(2) or
changing its regulations. Rather, consistent with EPA's section 6(a)(2)
regulations, EPA would be merely identifying a set of information that
adds to the subset of reportable section 6(a)(2) data explicitly
identified at present under the section 6(a)(2) regulations.
Further, the Agency notes that the identification of information as
reportable under FIFRA section 6(a)(2) does not mean that any
particular pesticide or group of pesticides, to which such information
pertains, poses a risk. Rather, the requirement merely indicates that
EPA has determined that a particular type of information is relevant
to, and may improve the Agency's ability to assess, whether the
pesticide would cause an unreasonable adverse environmental effect.
As part of this approach, EPA would also require that any such
information be reported in connection with any application to register
a pesticide product containing any nanoscale material (40 CFR
152.50(f)(3)). As with the reporting obligation under FIFRA section
6(a)(2), EPA would consider the failure to provide these types of
information with an application for a product containing nanoscale
material to be a violation of FIFRA sections 12(a)(2)(B)(ii) and
12(a)(2)(N).
Agency regulations implementing FIFRA section 6(a)(2) provide that
a registrant must submit information to EPA that is reportable under
section 6(a)(2) no later than the 30th calendar day after the
registrant first possesses or becomes aware of the information (40 CFR
159.155). In addition, a registrant is required to submit to EPA any
section 6(a)(2) information not explicitly covered under the section
6(a)(2) regulations if EPA has informed the registrant that such
additional information has the potential to raise questions about the
continued registration of a product or the appropriate terms and
conditions of registration of a product (40 CFR 159.195).
After learning that EPA was considering relying on FIFRA 6(a)(2) to
require reporting, some stakeholders raised questions about the use of
FIFRA section 6(a)(2) to obtain this information. Even though, as
stated above, EPA is not making a judgment that the presence of any
particular nanoscale material poses a risk, it has been argued that use
of the ``adverse effects'' reporting authority in FIFRA section 6(a)(2)
could create a ``stigma'' for the nanotechnology industry.
EPA does not believe that using FIFRA section 6(a)(2) to gather
information on the presence of nanoscale materials in pesticide
products would create a stigma for the nanotechnology industry. EPA's
longstanding interpretation of section 6(a)(2) is that it is not
limited to requiring reporting only of actual ``adverse effects'' of
pesticides, and its use does not imply that ``adverse effects''
actually have occurred, or even could occur, in connection with the
pesticide or pesticide ingredient on which the information is being
obtained. FIFRA section 6(a)(2) requires reporting of ``additional
factual information regarding unreasonable adverse effects on the
environment,'' where ``unreasonable adverse effects on the
environment'' is specifically defined as a risk/benefit standard. EPA's
implementing regulations require reporting of a wide range of data,
which--like information on nanoscale materials--are relevant to EPA's
risk/benefit evaluations, but which do not indicate the pesticide
causes any adverse effects. Any suggestion that this information
gathering proposal implied an EPA position on the adverse effects of
pesticides containing nanoscale materials would be a misinterpretation
of EPA's intent.
It is further EPA's position that merely filing an additional
report under FIFRA section 6(a)(2) does not stigmatize pesticides and
would not stigmatize any nanomaterials in pesticides, since filing such
reports is quite common. On average, EPA receives 200 studies and
56,000 incident reports per year under this authority. In
[[Page 35391]]
fact, over the last 10 years, pesticide registrants have filed section
6(a)(2) reports on more than two-thirds of all pesticide active
ingredients.
Use of FIFRA section 6(a)(2) also would have only a minimal overall
administrative burden for both EPA and industry. Under section 6(a)(2),
only registrants who know that their products contain nanoscale
materials would be required to report to EPA. Further, they would be
required to report only the information they know about. Section
6(a)(2) does not require a registrant to generate new data or to seek
out additional information. Further, registrants and applicants whose
products do not contain nanoscale materials (or who do not know that
their products contain nanoscale materials) would have no reporting
obligation under FIFRA section 6(a)(2). Under this approach, EPA would
be required to keep track of each response received under 6(a)(2), but
would not otherwise need to prepare or track individual requests for
the information.
B. DCIs Under FIFRA Section 3(c)(2)(B)
As an alternative to relying on FIFRA section 6(a)(2) to obtain
information concerning nanoscale materials in pesticides, EPA is also
considering issuing DCIs under FIFRA section 3(c)(2)(B). The Agency has
authority under FIFRA section 3(c)(2)(B) to issue a DCI notice to a
pesticide registrant directing them to provide data ``required to
maintain in effect an existing registration of a pesticide * * *'' The
DCI notice is addressed to an individual registrant, specifically
identifies the information or data that the registrant must provide,
prescribes an initial response deadline of 90 days, and, if data are to
be generated, it may prescribe a timeframe for generating and providing
that data. Under FIFRA, EPA can suspend the registration of a pesticide
if the registrant fails to respond to a DCI.
As part of this alternate approach, EPA would also need to require
the inclusion of this information with any application for registration
of a pesticide product that contains a nanoscale material. EPA is
reviewing whether this could be done under existing regulations or
whether EPA would need to amend existing regulations to clarify that
this information is required with any application for registration. As
with the reporting obligation under FIFRA section 6(a)(2), EPA would
consider the failure to provide these types of information with an
application for a product containing nanoscale material to be a
violation of FIFRA sections 12(a)(2)(B)(ii) and 12(a)(2)(N).
Since EPA's goal is to identify what nanoscale materials are
contained in products (and the products that contain them) and to
gather existing information not previously provided to assess their
safety, the DCI would need to require the kinds of information
specified in Unit IV. of this document. Because such a request is not
consistent with the Re-registration or Registration Review programs,
the Agency would use the Enforcement and Unanticipated Circumstances
category available in the currently approved Information Collection
Request (73 FR 55072, September 24, 2008) (FRL-8719-3).
Unless a registrant has already disclosed the presence of nanoscale
material in all of its products, there currently is no way to identify
with certainty what nanoscale materials are in products (and the
products that contain them). Therefore, in order to identify what
nanoscale materials are in products, EPA could initially send an
individual Enforcement and Unanticipated Circumstances DCI order to
each of the 1,716 currently registered pesticide producers. Under this
approach each of these pesticide registrants would then be required to
respond within 90 days by either providing the requested information
about the nanoscale materials in their product(s) or certifying that
their product(s) do not contain nanoscale materials. In addition to
keeping track of each response like under FIFRA section 6(a)(2), the
approach under FIFRA section 3(c)(2)(B) could require EPA to also
prepare and track the issuance of individual DCIs for each pesticide
registrant, as well as determine and take any necessary enforcement
actions for non-responders. EPA notes that only pesticide registrants
receive DCIs; EPA would need to employ additional administrative
procedures to ensure that applicants also provided such information.
A variation on this approach would be for EPA to craft a DCI that
would be more targeted and place less burden on industry and the
Agency, possibly by not requiring a response from recipients of the DCI
who do not have (or who do not know that they have) nanoscale material
in their registered pesticide products. The Agency has not used such an
approach with any DCI in the past; however, and a number of issues,
including enforcement, would need to be addressed if it were to seek to
do so here. EPA could also focus its initial data gathering on certain
classes of pesticides that might be most likely to contain a nanoscale
material that EPA would be interested in knowing about. EPA is
interested in receiving comments on these variations.
It is useful to note that while FIFRA section 6(a)(2) can be used
to obtain existing information, the DCI approach under FIFRA section
3(c)(2)(B) allows the Agency to request that data be generated. If EPA
uses FIFRA section 6(a)(2) authority and the Agency learns, for
instance, the identity of a nanoscale material present in a product,
and subsequently determines that sufficient data are not available to
support the continued registration of the pesticide, EPA could then use
the DCI approach under FIFRA section 3(c)(2)(B) to gather such
information. EPA must use the DCI approach if EPA intends to require a
registrant to provide information which the registrant does not already
possess.
It is anticipated that some registrants will request that EPA
review information to determine if their product contains nanoscale
materials. To the extent that the description of nanoscale material to
a particular product or ingredient is unclear, EPA will review
information concerning the composition and manufacturing process of the
pesticide product and, based on that information, the Agency will
determine whether the product does (or does not) contain nanoscale
material.
It has been suggested that the use of a 3(c)(2)(B) approach would
result in submission of information that only reflected the composition
of registrants' products at the time of their responses, but that EPA
would need periodically to issue DCIs to ensure that registrants did
not alter the composition of the products to add nanoscale materials
after submitting their responses. EPA is interested in receiving
comments on options whereby it can ensure registrants report what
nanoscale materials are in products, regardless of when they are added
to the pesticide.
Under either the 6(a)(2) or the 3(c)(2)(B) approach, DCIs targeted
to individual pesticide products that contain specific nanoscale
materials would likely be used in the future to collect more specific
information or data about particular products. EPA would consider doing
so on a case-by-case basis and would tailor any request for information
accordingly.
C. Amending the Pesticide Data Requirement Regulations
Some stakeholders have suggested, as an alternative to relying on
either FIFRA section 6(a)(2) or 3(c)(2)(B) DCIs to obtain information
concerning nanoscale materials in pesticides, that EPA instead
promulgate a regulation amending the data requirements in 40
[[Page 35392]]
CFR parts 158 and 161. The Agency could amend the data requirements to
include disclosure of what nanoscale materials are present as part of
the pesticide registration process. However, completing this action
would not provide information on currently registered pesticide
products.
The Agency sees such proposed rulemaking with a broader scope in
that it would address not only the basic information such as
identifying what nanoscale materials are in products, but also many
other types of data required for making safety evaluations. The Agency
is currently making data need decisions on a case-by-case basis, and
EPA is trying to tailor data requirements to the particular
characteristics of each product. The Agency does not yet have the
knowledge base typically gained through the registration process to
support the development of specific data requirements that would be
imposed broadly for the registration of pesticides containing nanoscale
materials across all the application and use scenarios, as required for
such a rulemaking.
Although it could take considerable time to finalize and implement
a rule establishing standard data requirements for pesticides
containing nanoscale materials, and the Agency thus believes that this
approach by itself would not generate information on nanoscale
ingredients in pesticides in a timely manner, EPA also seeks comment on
this approach.
VI. Proposed Policy Regarding Classification of Applications Under
FIFRA and PRIA for Products Containing Nanoscale Active and Inert
Ingredients
As discussed in more detail earlier in this document, under FIFRA,
all pesticides must meet stringent statutory and regulatory standards
before they are registered by the Agency and allowed to be marketed and
sold. Pesticides containing nanoscale materials, whether as active or
inert ingredients, must meet the same safety standards as other
pesticides. Because of the large and increasing body of data described
in Unit III.B. of this document demonstrating that size can alter the
manner in which materials behave and, in turn, the potential risk to
human health and the environment associated with such materials, EPA
proposes to apply an initial presumption that active and inert
ingredients, which are the nanoscale versions of non-nanoscale active
and inert ingredients already present in registered pesticide products,
are potentially different from those conventionally sized counterparts.
Because the size, shape, and other characteristics of nanoscale
ingredients are likely to vary widely, EPA also proposes to apply an
initial presumption that nanoscale active and inert ingredients are
potentially different even from other, already-registered nanoscale
versions of the same ingredients. As explained later in this document,
however, applicants can overcome this presumption on a case-by-case
basis.
Historically, EPA has evaluated an application for registration of
a pesticide product that claims to have the same composition and uses
as a currently registered pesticide--a so-called ``me-too
application''--under either the ``conditional'' registration or
``unconditional'' registration authorities in FIFRA section 3(c)(7) and
section 3(c)(5), respectively. In making the statutory determinations
under section 3(c)(7)(A)--whether the applicant's product is identical
or substantially similar to a currently registered pesticide or differs
only in ways that would not significantly increase the risk of
unreasonable adverse effects on the environment, and that approving the
registration in the manner proposed would not significantly increase
the risk of any unreasonable adverse effect on the environment--EPA has
focused on whether the use patterns of the products are identical or
similar and whether the ingredients present in the products have the
same chemical structure and are present in about the same percentages.
Until recently, EPA generally has not focused on the size of an
ingredient as an attribute relevant to making the determinations under
section 3(c)(7)(A).
As noted previously, however, once the size of an ingredient is
reduced below approximately 100 nm, a substance can exhibit different
properties, and therefore it may also have different potential
environmental health and safety properties. Accordingly, for a product
containing an ingredient that is a nanoscale version of a
conventionally sized active or inert ingredient contained in an
already-registered product, EPA may require additional data in order to
determine that the nanoscale material differs only in ways that do not
significantly increase the risk of unreasonable adverse effects on the
environment and that approving the registration in the manner proposed
would not significantly increase the risk of any unreasonable adverse
effect on the environment, and/or require different terms and
conditions for the registration. EPA is thus proposing that it not make
the requisite findings absent specific information on the nanoscale
material included in a pesticide product when the application relies on
a comparison to a currently registered pesticide product containing
either a non-nanoscale version of the same ingredient or another
nanoscale version of the ingredient that has different characteristics.
Under this approach, the Agency would follow the same thinking in
making the statutorily required determinations under FIFRA section
3(c)(7)(B) and 3(c)(7)(C), as well as FIFRA section 3(c)(5).
For purposes of registration under FIFRA section 3(c)(5) or
3(c)(7), therefore, EPA would initially classify any application for
registration of a pesticide product containing an active or inert
ingredient that is a nanoscale material as an application for a ``new''
active or inert ingredient, even when another registered pesticide
product contains a non-nanoscale form of the ingredient or a nanoscale
form of the ingredient with different size dimensions or other
properties. This initial presumption, however, could be rebutted on a
case-by-case basis through the submission of, among other
possibilities, bridging data or other information demonstrating to
EPA's satisfaction that the nanoscale material's properties, which are
relevant to assessing the potential risks to human health and the
environment, are substantially similar to the properties of the
already-registered non-nanoscale or already-registered nanoscale form
of the material, or that the nanoscale material differs only in ways
that do not significantly increase the risk of unreasonable adverse
effects on the environment, and that approving the registration in the
manner proposed would not significantly increase the risk of any
unreasonable adverse effect on the environment.
If an applicant could make this showing to EPA's satisfaction, then
the application would be processed as a ``me-too'' application within
the timeframes prescribed for such applications. However, if an
applicant could not make this showing to EPA's satisfaction, then EPA
would process such products as new active ingredients or new inert
ingredients and would complete its review within the timeframes
prescribed for such applications. In those circumstances, the Agency
would likely require the applicant to provide the types of data
typically required for an assessment of the potential hazards and
exposure to a new active or inert ingredient. Under this proposed
policy, it would also follow that if a registrant wished to change the
composition of its product to include a nanoscale version of a
[[Page 35393]]
material that EPA had previously approved in non-nanoscale form, the
registrant would need to notify EPA and obtain EPA approval before
making such a change in the composition of its product. However, as
noted earlier, the registration status of a product would not change
merely as a result of providing information to EPA about the presence
of a previously-unreported nanoscale material. If EPA made an
affirmative finding that a change in status or conditions of use was
necessary, EPA would notify the registrant in accordance with
applicable regulations and procedures.
VII. Does this document contain binding requirements?
This document seeks 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 pesticides. Given that the Agency is seeking
comment before determining its approach to obtaining information on
what nanoscale materials are in pesticides, there are no binding
requirements in this document.
Once this document is finalized, the Agency's policy for
determining whether a nanoscale material is a new active or inert
ingredient for purposes of both FIFRA and PRIA would be intended only
as guidance to EPA personnel and decision-makers and to pesticide
applicants. While the requirements in the statute and Agency
regulations are binding on EPA and the applicants, the proposed policy
described in this document would not be binding on EPA personnel,
pesticide applicants, or the public. Accordingly, EPA may depart from
the policy proposed herein if and when circumstances warrant. Likewise,
pesticide applicants may assert that the proposed policy is not
applicable to a specific pesticide or situation in which EPA may be
expected to apply it.
VIII. Questions for Comment
The Agency is seeking public comment on several questions,
including whether it should use the FIFRA section 6(a)(2) reporting
obligation to obtain information on what nanoscale materials are in
pesticide products or use FIFRA section 3(c)(2)(B) as described in this
document to obtain such information.
With respect to the scope of reportable information, EPA
specifically invites comments on the following issues:
1. In view of the Agency's goal of identifying what nanoscale
materials are in products so that EPA can determine whether it needs
additional data to evaluate the products' safety under FIFRA, should
EPA change the description of a ``nanoscale material''? For example,
should the size range remain ``between approximately 1 and 100 nm in
one dimension''? Are there other characteristics that EPA should
consider, e.g., morphology, including shape and crystal structure;
surface chemistry and reactivity; specific surface area, charge;
solubility; conductive, magnetic, and optical properties?
2. Should the reporting requirement apply only to nanoscale
material that is ``intentionally produced to have at least one
dimension that measures between approximately 1 and 100 nanometers,''
or should it also apply to naturally occurring materials? Why?
3. Is the meaning of ``intentionally produced'' sufficiently clear?
If not, in what circumstances would the term be unclear and how might
it be clarified? Would offering a consultation procedure--by which a
registrant or applicant describes to EPA the production process that
results in the presence of a material in the nanoscale size range, and
EPA responds with a determination regarding whether reporting is
required--be an acceptable approach to providing clarity?
4. Should the reporting requirement apply to ingredients in
pesticides that contain any amount of a nanoscale material, or should
the requirement apply only if an ingredient contains more than a
specified percentage (e.g., 10%) of nanoscale material? If the latter,
what should the specified percentage be and why?
5. How should the reporting requirement apply to a pesticide
manufacturer who purchases ingredients that may contain nanoscale
material?
6. Are there ways in which the description of ``nanoscale
materials'' can be refined and clarified, including ways in which
agglomeration and aggregation could be considered as well as
suggestions for ways in which more subjective criteria, such as
``unique or novel properties'' can be incorporated into the screening
criteria?
7. Is EPA's description of ``nanoscale material'' inconsistent with
other definitions of nanoscale material or similar terms? If so, please
comment on whether such differences create any regulatory issues. In
particular, does the focus on ``intentionally produced'' materials
create any such inconsistency with other definitions of nanoscale
materials or similar terms?
8. If a pesticide is identified as containing a particular
nanoscale material, what would be the most useful next steps to inform
EPA's understanding of potential risks associated with the pesticide?
Are there tests that could provide useful information toward an
understanding of risk that would be common to all nanoscale materials,
or should the data requirements necessarily be compound- and situation-
specific? How should bioavailability be considered in determining
testing requirements (e.g., are nano-particles respirable or bound to
other components)?
With respect to the proposed approaches, EPA is seeking comment on
how to implement them to ensure efficient, effective, and timely review
of applications. EPA specifically invites comments on the following
issues:
1. Is there a way to determine, in advance of receiving an
application for registration of a product containing a nanoscale
material, whether a particular kind of nanoscale material has
properties that, for purposes of risk assessment, are essentially the
same as larger sized materials of the same substance? If so, how would
such determinations be made and on what would they be based?
2. What kinds of information should EPA accept as demonstrating
that a pesticide product containing a nanoscale ingredient is identical
or substantially similar to a currently registered pesticide or differs
only in ways that would not significantly increase the risk of
unreasonable adverse effects on the environment, and that approving the
registration in the manner proposed would not significantly increase
the risk of any unreasonable adverse effect on the environment?
3. Can you suggest any alternative(s) to the proposed approaches
that would be equally or even more effective in addressing the status
of nanoscale materials as new active or inert ingredients for purposes
of both FIFRA and PRIA, keeping in mind the data showing that size,
especially when reduced below approximately 100 nm, may alter the
manner in which materials behave and, in turn, the potential risk to
human health and the environment associated with such materials?
With respect to the potential alternative ways of obtaining the
needed information on what nanoscale materials are in pesticide
products, EPA specifically invites comments on the following issues:
1. Has EPA appropriately characterized in this document the current
scientific understanding of the potential risks of nanoscale materials?
If not, please comment on how to
[[Page 35394]]
characterize the potential risks of nanoscale materials. How would the
perception of the risks of nanoscale materials differ depending on the
approach used by EPA to require needed data on nanoscale materials in
pesticides? How could EPA lessen the possibility that issuance of a
final requirement to report what nanoscale materials are in pesticides
will result in a public misunderstanding of the potential risks of
nanotechnology more generally?
2. Do commenters believe that identification of the nanoscale
materials in pesticide products is relevant to EPA's statutory
determination regarding the potential for unreasonable adverse effects
on the environment? Please provide the scientific or legal basis for
your view.
3. Has EPA characterized the alternative approaches with respect to
which they would: (a) result in a misunderstanding of the potential
risks posed by nanoscale materials; (b) result in the timely submission
of needed information; and (c) impose burdens on pesticide companies,
those whose products do, and do not, contain nanoscale materials? If
not, please comment on those issues.
4. If EPA uses FIFRA section 6(a)(2) to obtain the needed
information on nanoscale materials in pesticides, how could the Agency
ensure that its action is not mischaracterized or misunderstood as a
determination that the mere fact that a pesticide contains nanoscale
materials causes unreasonable adverse environmental effects?
5. If EPA were to use DCIs to obtain the needed information on
nanoscale materials in pesticides, how could EPA reduce both the
burdens on registrants and on EPA, as well as the time required to
complete such a process? For example, is it possible to reduce the
burdens on registrants by targeting only certain types of products? If
so, how would EPA determine which products should receive DCIs?
6. What are the advantages and disadvantages of requesting
information on nanoscale materials specifically versus requesting
information on size distribution generally? (Note that either type of
information could be collected under either the 6(a)(2) or the
3(c)(2)(B) approach, except that 6(a)(2) cannot be used to require the
production of new information that does not already exist, while a
collection under 3(c)(2)(B) must be directed to an individual
registrant and requires a response.) Is identifying what nanoscale
materials are in products a useful first step, or should EPA move
towards immediate collection of more specific information, such as
particle size distribution, on products that might contain nanoscale
materials? Are there other physical and/or chemical properties that
might be equally or more important for assessing the potential of a
pesticide to cause unreasonable adverse effects on the environment
(e.g., morphology, including shape and crystal structure; surface
chemistry and reactivity; specific surface area, charge; solubility;
conductive, magnetic, and optical properties)? Should information on
these properties be separately requested? What would be the value and
burden of obtaining such information?
1. If EPA were to use rulemaking to establish data requirements for
pesticides containing nanoscale materials, what types of information
should EPA use to determine appropriate data requirements? What types
of studies should EPA require to evaluate a nanoscale material?
2. When choosing an approach for obtaining needed data, how should
EPA weigh considerations relating to the need to update its safety
evaluations of currently marketed pesticides in a timely manner, the
goal of ensuring marketplace equity, and the interest in minimizing the
burdens on regulated entities?
IX. References
As indicated under ADDRESSES, a docket has been established for
this document under docket ID number EPA-HQ-OPP-2010-0197. The
following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical contact person listed under FOR FURTHER INFORMATION CONTACT.
1. Oberd[ouml]rster, G. et al. 2005. Nanotoxicology: an emerging
discipline evolving from studies of ultrafine particles.
Environmental Health Perspectives. (113):823-839.
2. National Nanotechnology Initiative. 2011. Strategic Plan. http://www.nano.gov/nnistrategicplan211.pdf.
3. Department of Health and Human Services. Centers for Disease
Control and Prevention. National Institute for Occupational Safety
and Health. Approaches to Safe Nanotechnology: Managing the Health
and Safety Concerns Associated with Engineered Nanomaterials.
November 2009. http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf.
4. SCENIHR. 2009. Risk Assessment of Products of Nanotechnologies.
European Commission. Directorate-General for Health and Consumers.
Scientific Committee on Emerging and Newly Identified Risks,
Brussels: 28th Plenary Meeting. January 19, 2009. http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_s_01.pdf.
5. Seaton, A. et al. 2010. Nanoparticles, human health hazard and
regulation. J.R. Soc. Interface 7:S119-S129. http://rsif.royalsocietypublishing.org/content/early/2009/08/31/rsif.2009.0252.focus.full#ref-14.
6. Wick, P. et al. 2009. Barrier Capacity of Human Placenta for
Nanosized Materials. Environ. Health Perspect. 118:432-436.http://ehp.niehs.nih.gov/members/2009/0901200/0901200.pdf.
7. Kim, Y.S. et al. 2008. Twenty-Eight Day Oral Toxicity,
Genotoxicity, and Gender-Related Tissue Distribution of Silver
Nanoparticles in Sprague-Dawley Rats. Inhalation Toxicology. 20
(6):575-583.
8. Handy et al. 2008. The ecotoxicology and chemistry of
manufactured nanoparticles. Ecotoxicology 17:287-314.
9. Klaine et al. 2008. Nanomaterials in the Environment: Behavior,
Fate, Bioavailability, and Effects. Environ. Toxicol. Chem. 27:
1825-1851.
10. Federici et al. 2007. Toxicity of titanium dioxide to rainbow
trout (Oncorhynchus mykiss): Gill injury, oxidative stress, and
other physiological effects. Aquat. Toxicol. 84:415-430.
11. Smith et al. 2007. Toxicity of single walled carbon nanotubes on
rainbow trout (Oncorhyncos mykiss): Respiratory toxicity, organ
pathologies, and other physiological effects. Aquat. Toxicol. 82:94-
109.
12. Lovern and Klaper. 2006. Daphnia magna mortality when exposed to
titanium nanoparticles and fullerene (C60) nanoparticles. Environ.
Toxicol. Chem. 25:1132-1137.
13. Oberdorster et al. 2006. Ecotoxicology of carbon-based
engineered nanoparticles: effects of fullerene (C-60) on aquatic
organisms. Carbon 44:1112-1120.
14. Roberts et al. 2007. In vivo biomodification of lipidcoated
carbon nanotubes by Daphnia magna. Environ. Sci. Technol. 41:3025-
3029
15. Kashiwada et al. 2006. Distribution of nanoparticles in the see-
through Medaka (Oryzias latipes). Environ. Health Perspect.
114:1697-1702.
16. Cheng et al. 2007. Effect of carbon nanotubes on developing
zebrafish (Danio rerio) embryos. Environ. Toxicol. Chem. 26:708-716.
17. Kahru and Dubourguier. 2010. Review: From ecotoxicology to
nanoecotoxicology. Toxicology 269:105-119.
18. FIFRA Science Advisory Panel (SAP). 2010. ``Evaluation of Hazard
and Exposure Associated with Nanosilver and Other Nanometal
Pesticide
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Products.'' Report from the FIFRA Scientific Advisory Panel Meeting
of November 2009. http://www.epa.gov/scipoly/sap/meetings/2009/november/110309ameetingminutes.pdf.
X. Applicable Statutory and Executive Order Reviews
EPA submitted this document to the Office of Management and Budget
(OMB) for review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Any changes made in
response to OMB recommendations have been documented in the docket for
this action as required by section 6(a)(3)(E) of the Executive Order.
The information collection requirements associated with reporting
under FIFRA section 6(a)(2) as prescribed in 40 CFR part 159, subpart D
are approved under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq. The approval is identified under OMB Control No. 2070-0039 and EPA
ICR No. 1204. The information collection requirements associated with
DCIs is approved under OMB Control No. 2070-0174 and identified by EPA
ICR No. 2288. If EPA were to finalize a policy that required additional
reporting of information not currently collected, or that substantively
changed the burden for such reporting (for example if it resulted in a
larger number of such reports than covered in current burden
estimates), EPA would submit a request for revised PRA approval to OMB.
The various other statutory and Executive Order review requirements
that apply to a regulatory action do not apply to this action because
this document is not a regulatory action and does not otherwise impose
new requirements. As indicated previously, this document requests
comment on several approaches for applying existing requirements in
order to obtain information on nanoscale materials in pesticide
products and presents the Agency's proposed policy for determining
whether a nanoscale material is a new active or inert ingredient for
purposes of both FIFRA and PRIA.
List of Subjects
Environmental protection, Administrative practice and procedure,
Nanotechnology, Pesticides and pests.
Dated: June 8, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2011-14943 Filed 6-16-11; 8:45 am]
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