Declaration of Prion as a Pest Under FIFRA and Amendment of EPA's Regulatory Definition of Pests To Include Prion, 4602-4608 [2011-1636]
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Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Proposed Rules
contact Ms. Cheryl Vetter, Air Quality
Policy Division, Office of Air Quality
Planning and Standards (C504–03),
Environmental Protection Agency,
Research Triangle Park, NC 27711;
telephone number: (919) 541–4391; fax
number: (919) 541–5509; e-mail address:
vetter.cheryl@mailto:epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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A. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through https://
www.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. Send or deliver
information identified as CBI only to the
following address: Roberto Morales,
OAQPS Document Control Officer
(C404–02), U.S. EPA, Research Triangle
Park, NC 27711, Attention Docket ID
No. EPA–HQ–OAR–2010–1033.
2. Tips for Preparing Your Comments.
When submitting comments, remember
to
• Identify the rulemaking by docket
number and other identifying
information (subject heading, Federal
Register date and page number).
• 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.
• Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
• Describe any assumptions and
provide any technical information and/
or data that you used.
• If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
• Provide specific examples to
illustrate your concerns, and suggest
alternatives.
• Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
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• Make sure to submit your
comments by the comment period
deadline identified.
B. Where can I get a copy of this
document and other related
information?
In addition to being available in the
docket, an electronic copy of this notice
will also be available on the World
Wide Web (WWW). Following
signature, a copy of this notice will be
posted in the regulations and standards
section of our EPA New Source review
home page located at https://
www.epa.gov/nsr.
Dated: January 20, 2011.
Mary E. Henigin,
Acting Director, Office of Air Quality Planning
and Standards.
[FR Doc. 2011–1637 Filed 1–25–11; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 152
[EPA–HQ–OPP–2010–0427; FRL–8850–4]
RIN 2070–AJ26
Declaration of Prion as a Pest Under
FIFRA and Amendment of EPA’s
Regulatory Definition of Pests To
Include Prion
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA proposes to declare a
prion (i.e., proteinaceous infectious
particle) a ‘‘pest’’ under the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA), and to amend its
regulations to expressly include prion
within the regulatory definition of pest.
EPA currently considers a prion to be a
pest under FIFRA, so a product
intended to reduce the infectivity of any
prion on inanimate surfaces (i.e., a
‘‘prion-related product’’) is considered to
be a pesticide and regulated as such.
Any company seeking to distribute or
sell a pesticide product regulated under
FIFRA must obtain a section 3
registration, section 24(c) registration, or
a section 18 emergency exemption
before it can be distributed or sold in
the United States. This proposed rule
would codify the Agency’s current
interpretation of FIFRA, and provides
interested parties the opportunity to
comment about how it is adding prion
to the list of pests in the regulatory
definition of pest. This amendment,
together with the formal declaration that
a prion is a pest, will eliminate any
SUMMARY:
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confusion about the status of prionrelated products under FIFRA.
Codifying the Agency’s current
interpretation of FIFRA will not change
the manner in which EPA currently
regulates prion-related products under
FIFRA sections 3, 24(c) and 18.
Regulating prion-related products under
FIFRA is appropriate for protecting
human health and the environment
against unreasonable adverse effects and
ensuring that such products are
effective.
DATES: Comments must be received on
or before March 28, 2011.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2010–0427, by
one of the following methods:
• Federal eRulemaking Portal: https://
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–
0427. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
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 email. The regulations.gov website 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
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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 https://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 https://
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: Jeff
Kempter, Antimicrobials Division,
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5448; fax number: (703) 308–
6467; e-mail address:
kempter.carlton@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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A. Does this action apply to me?
You may be potentially affected by
this action if you apply for or own
pesticide registrations. Potentially
affected entities may include, but are
not limited to:
• Producers of pesticide products
(NAICS code 32532).
• Producers of antimicrobial
pesticides (NAICS code 32561).
• Veterinary testing laboratories
(NAICS code 541940).
• Medical pathology laboratories
(NAICS code 621511).
• Taxidermists, independent (NAICS
code 711510).
• Surgeons (NAICS code 621111).
• Dental surgeons (NAICS code
621210).
• Mortician services (NAICS code
812210).
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• Manufacturers of medical tissue
devices of human and animal origin
(NAICS code undetermined).
• Manufacturers of other human
cellular and tissue products (NAICS
code undetermined).
• Organ banks, body (NAICS code
621991).
• Plasma, blood, merchant
wholesalers (NAICS code 424210).
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 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.
B. 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
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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, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
II. Background
A. What action is the Agency taking?
EPA has decided that under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) a prion is
considered to be a pest, and proposes to
declare a prion to be a pest and to
explicitly include it in the lists of pests
in 40 CFR 152.5. These actions would
affirm the Agency’s authority to regulate
products distributed or sold for the
purpose of reducing the infectivity of
prions on inanimate surfaces (i.e., prionrelated products). Prion-related
products are currently regulated under
FIFRA and subject to all requirements
and provisions of the Act based on
EPA’s September 10, 2003 decision that
prions share enough characteristics of
an ‘‘other micro-organism’’ or ‘‘form of
life’’ (as those terms are used in FIFRA)
to fall within the scope of FIFRA section
2(t) and 40 CFR 152.5(d). This proposal
ensures that the regulatory definition
reflects the Agency’s authority to
regulate products distributed or sold for
the purpose of reducing the infectivity
of prions on inanimate surfaces (i.e.,
prion-related products). The primary
impact of declaring that a prion is a pest
and including ‘‘prion’’ in the regulatory
definition of ‘‘pest’’ is to provide
regulatory clarity that prion-related
products must be registered or
exempted under FIFRA sections 3,
24(c), or 18 before such products may be
distributed or sold in the United States.
Note that not all prions and prionrelated products are affected by the
proposed rule. Firstly, EPA’s regulations
at 40 CFR 152.5(d) exclude pests ‘‘* * *
in or on living man or other living
animals and those on or in processed
food or processed animal feed,
beverages, drugs * * * and cosmetics.’’
Therefore, the proposed rule would not
apply to those uses of prion-related
products. Secondly, the definition of
‘‘pesticide’’ in FIFRA section 2(u)
excludes new animal drugs and liquid
chemical sterilants intended for use on
a critical or semi-critical device.
Accordingly, products which fall into
those categories would not be covered
by the proposed rule.
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B. What is the Agency’s authority for
taking this action?
This action is issued under the
authority of sections 2 through 34 of
FIFRA (7 U.S.C. 136–136y).
III. Prion as a Pest Under FIFRA
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A. What is a prion?
Prions (‘‘proteinaceous infectious
particles’’) may occur in the central
nervous system tissues of animals as an
abnormal (‘‘misfolded’’), infectious form
of prion protein. Prion protein in its
normal form, or conformation, can be
designated PrPc (‘‘cellular’’ isoform)
while abnormal conformations of prion
proteins are generally called prions.
Different types of prions are commonly
designated by the type of diseases they
produce, such as PrPSc (prions
associated with scrapie) and PrPBSE
(prions associated with bovine
spongiform encephalopathy—mad cow
disease).
In the disease process, prions (such as
PrPsc) recruit normal prion proteins
(PrPc) and convert them into prions
(e.g., another copy of PrPSc). This
recruitment and conversion process
results in the progressive accumulation
of disease-producing prions. When this
process takes place in the brain, it
causes disease that slowly progresses
from neuronal dysfunction and
degeneration to death. These
neurodegenerative prion diseases are
known collectively as transmissible
spongiform encephalopathies (TSEs).
TSEs include scrapie disease in sheep,
bovine spongiform encephalopathy
(BSE) in cattle, chronic wasting disease
(CWD) in deer and elk, kuru and variant
Creutzfeld-Jakob Disease (vCJD) in
humans, and similar diseases in other
animals. EPA and other agencies are
concerned that animal-related prions
may spread to other animals (e.g.,
scrapie to sheep, CWD to cervids) or to
humans (e.g., BSE), and that humanrelated prions may be passed to other
humans (e.g., kuru or CJD). These
diseases are always fatal in humans and
animals alike, and there are no known
treatments or cures.
B. Legal/Regulatory Background
Under section 25(c)(1) of FIFRA, the
Administrator, after notice and
opportunity for hearing, is authorized
‘‘to declare a pest any form of plant or
animal life (other than man and other
than bacteria, virus, and other microorganisms on or in living man or other
living animals) which is injurious to
health or the environment.’’ Therefore,
the Agency has the authority to decide
whether or not a prion should be
considered to be a pest under FIFRA
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and whether to issue a regulation
implementing that decision.
On September 10, 2003, the EPA
decided that a prion should be
considered to be a ‘‘pest’’ under FIFRA
and that products intended to inactivate
prions (i.e., ‘‘prion-related products’’)
should be regulated under FIFRA (Ref.
1). This decision was made partly in
connection with the widespread
occurrence of chronic wasting disease
(CWD) among deer and elk in a number
of states, particularly in the Rocky
Mountain region. Although CWD had
been endemic to that region for a long
time, concerns were growing inside and
outside of EPA as to how to prevent or
minimize the movement of what is
believed to be the causative agent for
CWD—prions—through the
environment.
At the same time, EPA was receiving
inquiries from states about obtaining
FIFRA section 18 exemptions to allow
use of a disinfectant against prions on
inanimate surfaces in government and
commercial laboratories. EPA was also
aware that the World Health
Organization (WHO) recommended the
use of sodium hydroxide or sodium
hypochlorite for treating surfaces
potentially contaminated with prions
even though those chemicals were not
registered by EPA for that specific
purpose. Subsequent to the September
2003 decision, EPA has granted a total
of 19 quarantine exemptions under
FIFRA section 18 to numerous states
(California, Colorado, Maine,
Minnesota, Montana, North Dakota,
South Dakota, Utah, and Wyoming) and
the U.S. Department of Agriculture
(USDA) for the use of a commercial
aqueous acid phenolic product, Environ
LpH, for treatment on hard, nonporous
surfaces in government and commercial
laboratories contaminated with CWD
and other kinds of prions.
Other Federal agencies are
responsible for implementing controls
to prevent the spread of prion diseases
to animals and humans. For example, to
eliminate scrapie within the United
States, USDA’s Animal and Plant Health
Inspection Service (APHIS) administers
the national scrapie eradication program
(9 CFR parts 54 and 79). APHIS also
intends to establish a herd certification
program to prevent and control CWD
from farmed or captive cervids in the
United States (9 CFR parts 55 and 81).
In addition, APHIS regulates the
importation of animals and animal
products into the United States to guard
against the introduction of various
animal diseases, including BSE (9 CFR
parts 92, 93, 94, and 95). To prevent the
spread of BSE through animal feed, the
Food & Drug Administration (FDA)
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prohibits the use of most mammalian
protein in the manufacture of animal
feed used for ruminants and prohibits
high risk cattle materials from all animal
feed (21 CFR part 589). To prevent
potential human exposure to the BSE
agent, USDA’s Food Safety and
Inspection Service prohibits for use as
human food cattle materials that could
potentially contain the BSE agent (9
CFR 310.22). FDA has also issued an
interim final rule (69 FR 42256, July 14,
2004) prohibiting the use of certain
cattle materials in human food and
cosmetics to address the potential risk
of BSE (21 CFR 189.5 and 700.27).
C. EPA’s Interpretation of FIFRA
1. Applicable FIFRA provisions.
FIFRA section 25(c)(1) authorizes the
Administrator ‘‘to declare a pest any
form of plant or animal life (other than
man and other than bacteria, virus, and
other micro-organisms on or in living
man or other living animals) which is
injurious to health or the environment.’’
FIFRA section 2(t) defines a pest, in
part, as ‘‘* * * any other form of
terrestrial or aquatic plant or animal life
or virus, bacteria or other microorganism * * * which the
Administrator declares to be a pest
under section 25(c)(1).’’ These FIFRA
sections provide EPA the authority to
declare an entity to be a ‘‘pest’’ if it
meets these statutory provisions.
2. EPA’s interpretation of FIFRA.
EPA’s decision to declare a prion to be
a pest under FIFRA rests on its statutory
interpretation of FIFRA sections 25(c)(1)
and 2(t). EPA believes that Congress
intended that the phrases ‘‘any other
form of plant or animal life’’ and ‘‘other
micro-organism’’ be broadly interpreted
to include biological entities that are
injurious to humans or the environment.
The following points provide EPA’s
rationale for this interpretation.
• In FIFRA, Congress has over the
years used the term ‘‘other microorganism’’ more broadly than most
microbiologists currently would define
the term because, as used in FIFRA, the
term ‘‘micro-organism’’ includes viruses,
which many microbiologists do not
consider to be microorganisms.
Therefore, the term ‘‘micro-organism,’’ as
currently defined by many
microbiologists, is narrower than the
potential scope of the term ‘‘other microorganism’’ in FIFRA.
• As used in FIFRA, the term ‘‘other
micro-organism’’ includes entities other
than viruses and bacteria, but it is
unclear which entities. It is reasonable
to assume that it includes those entities
that most microbiologists currently
recognize as microorganisms (i.e.,
microfungi, yeasts, and protists).
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Because the statutory language
explicitly includes viruses among
micro-organisms in the definition of
‘‘pest,’’ the term ‘‘other micro-organism’’
in its statutory context reasonably may
be interpreted to include some other
entities that many microbiologists may
not categorize as microorganisms.
• Today, microbiologists do not
generally classify viruses as
microorganisms because they are not
alive (i.e., they cannot reproduce
sexually or asexually, grow or perform
self-maintenance). Therefore, the term
‘‘other micro-organism’’ as used in
FIFRA appears broad enough to include
some entities that are not alive.
• Congress’ rationale for including
viruses within the FIFRA definition of
‘‘pest’’ is not known as there is no
available legislative history on this
issue. However, it is reasonable to infer
that Congress included viruses within
the FIFRA definition of ‘‘pest’’ and
within the scope of the meaning of
‘‘micro-organism’’ because viruses share
important characteristics of other pests.
The characteristics of a virus that make
it resemble a micro-organism in the
context of ‘‘pest’’ are pathogenicity,
infectivity, transmissibility, the ability
to increase in number, and the ability to
evolve. EPA believes that Congress
intended the terms ‘‘pest’’ and ‘‘other
micro-organism’’ as used in FIFRA to be
broadly inclusive.
• One entity that shares the
characteristics of pathogenicity,
infectivity, transmissibility, the ability
to increase in number, and the ability to
evolve (but which, like viruses, is not
alive) is the prion. A prion is an
infectious agent occurring in the tissues
of animals that is widely, though not
universally, believed to be composed of
an abnormal (misfolded) protein
without nucleic acid. Prions are also
unquestionably injurious to the health
of humans and other animals. They
cause TSE diseases that attack the
nervous system, inflict irreversible
damage, and are always fatal to infected
animals and humans. Once introduced
into an animal or human host, prions
can induce the formation of new prions
in the animal or human host. Prions are
considered among the most difficult of
all biological entities to mitigate and
few methods are available for effectively
doing so. Moreover, current test
methods cannot demonstrate complete
destruction or inactivation of prions.
For these reasons, EPA believes that the
public needs assurance of the safety and
efficacy of products intended to reduce
the infectivity of prions.
• Congress expressly included
‘‘prion’’ within another statute’s
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definition of ‘‘pest,’’ namely in the
Animal Health Protection Act of 2002.
For these reasons, EPA concluded that
a prion is appropriately included in the
phrase ‘‘other micro-organism.’’ Because
prions are also severely injurious to
human and animal health, EPA has also
concluded that a prion is appropriately
included in the FIFRA definition of
‘‘pest.’’
D. EPA’s Prion Science Evaluation and
Efficacy Test Guidance Documents
To assure that this rulemaking is
based on the best available scientific
information, EPA reviewed and
summarized the most relevant scientific
studies and publications related to the
issue of whether a prion is a pest in a
‘‘white paper’’ (Ref. 2). EPA presented
the draft white paper to the FIFRA
Scientific Advisory Panel (SAP) for peer
review and comment on March 31 and
April 1, 2009. The SAP provided
comments to EPA on the draft white
paper on June 29, 2009 (Ref. 3). EPA
subsequently responded to the SAP’s
comments (Ref. 4) and made revisions to
the white paper in response to the SAP
comments (Ref. 5). All of these
referenced documents are available in
the docket for this declaration and
proposed rule.
IV. FIFRA Review Requirements
In accordance with FIFRA section
25(a), EPA has submitted a draft of the
proposed rule to the FIFRA SAP, the
Secretary of Agriculture (USDA), and
appropriate Congressional Committees.
In addition, pursuant to FIFRA section
21(b), EPA submitted a draft of the
proposed rule to the Secretary of Health
and Human Services (HHS).
The FIFRA SAP waived its review of
this proposal on June 1, 2010, because
the significant scientific issues involved
have already been reviewed by the SAP
and additional review is not necessary.
A copy of this waiver is available in the
docket.
As required by FIFRA section 25(a),
the written comments on the draft
proposal received from USDA and HHS,
along with EPA responses, are available
in the docket. EPA addressed these
comments as part of the interagency
review process under Executive Order
12866, and changes made to the
proposed rule in response to all
comments received during that
interagency review are documented in
the docket as required by Executive
Order 12866.
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V. Statutory and Executive Order
Reviews
A. Regulatory Review
Pursuant to Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993),
the Office of Management and Budget
(OMB) has determined that this
proposed rule is a ‘‘significant regulatory
action’’ because this action might raise
novel legal or policy issues arising out
of legal mandates, the President’s
priorities, or the principles set forth in
the Executive Order. Accordingly, EPA
submitted this proposed rulemaking to
OMB for review under Executive Order
12866. Any changes made in response
to OMB comments have been
documented in the docket for this
rulemaking as required by the Executive
Order.
EPA has prepared an economic
analysis of the potential costs associated
with this proposed action, entitled
Economic Analysis of the Notice of
Proposed Rulemaking Concerning the
Status of Prion as a Pest under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (Ref. 8). A copy
of this document is available in the
docket for this rulemaking, and is
briefly summarized here.
The Economic Analysis (EA) presents
the Agency’s assessment of the potential
costs and benefits expected to result
from the proposed rule. In terms of
benefits, the proposed rule will ensure
that EPA can protect human health and
the environment by subjecting prionrelated products to regulation under
FIFRA, including all data and labeling
requirements. In terms of costs, using
pre-2003 costs as the baseline, the
incremental costs of the proposed rule
per registration action range from
$424,000 to $4.72 million.
The EA presents the costs of various
types of registrations under the
proposed rule and presents expected
incremental costs for three product
registration types. The three types of
registration actions which are possible
under the proposed rule are the
registration of: (1) A new active
ingredient, (2) a new use product, or
(3) a new use amendment registration.
The EA estimates that three firms may
seek registrations for major new use
products in the first year. If all uses are
high exposure (e.g., indirect food uses),
the maximum potential total cost to
industry in the first year would be
approximately $7.05 million, and costs
per firm would be approximately $2.35
million. Given the uncertainty that
characterizes the market for prionrelated products at this time, the Agency
did not speculate further on the
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expected number of registrations in
subsequent years. However,
registrations that occur after the initial
major new use product registrations
would probably be major new use
amendments. Data requirements would
entail only product-specific efficacy
data for major new use amendments at
a cost of approximately $431,000 per
registration action. Approximately 80%
of the firms in the pesticide
manufacturing industry are small firms
with revenues of $22 million, on
average. A cost of $7.05 million suggests
that the incremental cost per firm of
$2.35 million dollars would equal
nearly 11% of annual revenues.
However, after the initial three
registrations, a major new use
amendment at a cost of $431,000 would
represent fewer than 2% of average
annual revenues.
The EA identifies three categories of
persons who could be affected by the
proposed rule—pesticide registrants,
users of prion-related products, and
researchers. The registration related
requirements under FIFRA, however,
are imposed on the entity that registers
the prion-related product. Users of
prion-related products and researchers
are affected indirectly. The EA
summarizes potential qualitative
impacts of regulating prion-related
products that were expressed by
product users to EPA during its
outreach efforts to these users.
The EA evaluates the impacts of the
data required to support the registration
of a prion-related product, specifically
the need for a product performance test
that will measure the ability of an
individual product to reduce the
infectivity of prions. The Agency has
developed draft test guidelines for
prions which will ensure that the
Agency receives the data needed to
make objective and reliable
determinations as to whether a prionrelated product meets the Agency’s
efficacy data requirements for
registration. Providing clear guidance on
EPA’s efficacy data requirements for
prion-related products will benefit
registrants by enabling them to submit
relevant, correct and complete data
submissions in support of applications
for registration to the Agency.
One unintended consequence of using
products approved for use under FIFRA
section 18 exemptions is that at least
one state, California, requires that such
products be applied only by certified
applicators. EPA further understands,
however, that California has no such
requirement for pesticide products that
are registered under FIFRA section 3 or
24(c) that are not classified for restricted
use. Hence, laboratories in California
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that use prion-related products
registered under section 3 or 24(c)
would not be subject to a certified
applicator requirement. The initial cost
of obtaining the certified applicator’s
license in California is $140, and the
renewal fee is $60 every 2 years (see
https://www.cdpr.ca.gov/docs/license/
qac.htm). In addition, 20 hours of
continuing education is required to
obtain renewal. If a similar requirement
is imposed by other states, the cost to
laboratories for obtaining applicator
licenses would probably be about the
same. No such cost is associated with
products registered under section 3 or
24(c).
B. Paperwork Activities
The information collection
requirements, i.e., the paperwork
collection activities, contained in this
proposal are already approved by OMB
under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq.
Specifically, the activities contained in
this proposed rule are already addressed
in the following information collection
requests (ICRs):
1. The activities associated with the
establishment of a tolerance are
currently approved under OMB Control
No. 2070–0024 (EPA ICR No. 0597).
2. The activities associated with the
application for a new or amended
registration of a pesticide are currently
approved under OMB Control No. 2070–
0060 (EPA ICR No. 0277).
3. The activities associated with the
generation of data in response to a DataCall-In issued subsequent to registration
(e.g., as part of the review of an existing
registration), are currently approved
under OMB Control No. 2070–0174
(EPA ICR No. 2288).
The existing ICRs cover the
paperwork activities contained in this
proposal because the activities already
occur as part of existing program
activities. These program activities are
an integral part of the Agency pesticide
program and the corresponding ICRs are
regularly renewed. Although this
proposal involves already approved
activities, the estimated frequency of
those activities may increase as a result
of this proposal. The total estimated
average annual public reporting burden
currently approved by OMB for these
various activities ranges from
approximately 8 hours to 3,000 hours
per respondent, depending on the
activity and other factors surrounding
the particular pesticide product.
According to EPA’s EA for this
proposed rule (Ref. 8), using the
estimate of three major new use product
registrations in the first year, the
additional registration of three
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Fmt 4702
Sfmt 4702
antimicrobial products making prionrelated claims will result in an increase
in new registration applications for the
Agency from 140 to 143 and an increase
in tolerance petitions of from 64 to 67.
The increase in paperwork burden for
the registrant will be nearly $38,000
(600 hours for three registrations) for
registration activities and a little more
than $423,000 (5,200 hours for three
registrations) for paperwork for
tolerance petitions (Ref. 8).
An agency may not conduct or
sponsor, and a person is not required to
respond to an information collection
request unless it displays a currently
valid OMB control number, or is
otherwise required to submit the
specific information by a statute. The
OMB control numbers for EPA’s
regulations, after appearing in the
preamble of the final rule, are listed in
40 CFR part 9 and 48 CFR chapter 15,
and included on the related collection
instrument (e.g., form or survey).
Under the PRA, ‘‘burden’’ means the
total time, effort, or financial resources
expended by persons to generate,
maintain, retain, or disclose or provide
information to or for a Federal agency.
This includes the time needed to review
instructions; develop, acquire, install,
and utilize technology and systems for
the purposes of collecting, validating,
and verifying information, processing
and maintaining information, and
disclosing and providing information;
adjust the existing ways to comply with
any previously applicable instructions
and requirements; train personnel to be
able to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
Comments are requested on the
Agency’s need for this information, the
accuracy of the burden estimates, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
techniques. Send comments to EPA as
part of your overall comments on this
proposed action in the manner specified
under ADDRESSES. In the final rule, the
Agency will address any comments
received regarding the information
collection requirements contained in
this proposed rule.
C. Small Entity Impacts
Pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA), 5
U.S.C. 601 et seq., after considering the
potential economic impacts of this
proposed rule on small entities, I hereby
certify that this proposed rule would not
have a significant adverse economic
impact on a substantial number of small
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entities. This determination is based on
the Agency’s economic analysis (Ref. 8),
and is briefly summarized here.
Under the RFA, small entities include
small businesses, small organizations,
and small governmental jurisdictions.
For purposes of assessing the impacts of
today’s proposed rule on small entities,
small entity is defined as: (1) A small
business as defined by the Small
Business Administration’s (SBA)
regulations at 13 CFR 121.201 (in this
case based on maximum number of
employees or sales for small businesses
in each industry sector, as defined by a
6-digit NAICS code); (2) a small
governmental jurisdiction that is a
government of a city, county, town,
school district or special district with a
population of less than 50,000; and (3)
a small organization that is any not-forprofit enterprise which is independently
owned and operated and is not
dominant in its field. Since the
regulated community does not include
small governmental jurisdictions or
small not-for-profit organizations, the
analysis focuses on small businesses.
According to the Agency’s economic
analysis (Ref. 8), only three firms are
expected to apply for registrations of
prion-related products. One of these
firms is known to be a large firm. Given
that approximately 79% of the firms in
the antimicrobial industry are small
firms, it is possible that any or all of the
remaining two other firms could qualify
as a small entity under the SBA
definition.
The incremental costs of the proposed
rule could represent from 2% to 11% of
the average annual revenues of a small
firm. In general, the Agency does not
believe that prion-related products are
an important market segment for
sodium hydroxide or sodium
hypochlorite producing firms and does
not anticipate a large number of product
registrations beyond the first year the
final rule would take effect. If small
entities apply to register products for
prion control, they would likely pursue
a registration where they could likely
cite a substantial amount of data and not
incur 100% of the initial costs of testing
(Ref. 8).
EPA continues to be interested in the
potential impacts of this proposed rule
on small entities and welcomes
comments on issues related to such
impacts.
D. Unfunded Mandates
This action does not contain any
Federal mandates for State, local, or
tribal governments or the private sector
under the provisions of Title II of the
Unfunded Mandates Reform Act
(UMRA), 2 U.S.C. 1531–1538. EPA has
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17:13 Jan 25, 2011
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determined that this regulatory action
will not result in annual expenditures of
$100 million or more for State, local,
and tribal governments, in the aggregate,
or for the private sector. As described in
Unit IV.A., the incremental costs for the
proposed rule are estimated from
$424,000 to $4.72 million. Since State,
local, and tribal governments are rarely
pesticide applicants, the proposed rule
is not expected to significantly or
uniquely affect small governments. As
such, EPA has determined that this
action does not impose any enforceable
duty, contain any unfunded mandate, or
otherwise have any affect on small
governments. Accordingly, this action is
not subject to the requirements of
sections 202, 203 or 205 of UMRA.
E. Federalism Implications
Pursuant to Executive Order 13132,
entitled Federalism (64 FR 43255,
August 10, 1999), EPA has determined
that this proposed rule does not have
‘‘federalism implications’’ because it will
not have substantial direct effects on the
states, on the relationship between the
national government and the states, or
on the distribution of power and
responsibilities among the various
levels of government, as specified in the
Order. As indicated previously,
instances where a state is a registrant are
extremely rare. Therefore, this proposed
rule may seldom affect a state
government. Thus, Executive Order
13132 does not apply to this proposed
rule.
In the spirit of the Order, and
consistent with EPA policy to promote
communications between the Agency
and State and local governments, EPA
specifically solicits comment on this
proposed rule from State and local
officials.
F. Tribal Implications
As required by Executive Order
13175, entitled Consultation and
Coordination with Indian Tribal
Governments (65 FR 67249, November
6, 2000), EPA has determined that this
proposed rule does not have ‘‘tribal
implications’’ because it will not have
substantial direct effects on tribal
governments, on the relationship
between the Federal government and
the Indian tribes, or on the distribution
of power and responsibilities between
the Federal government and Indian
tribes, as specified in the Order. As
indicated previously, at present, no
tribal governments hold, or have
applied for, a pesticide registration.
Thus, Executive Order 13175 does not
apply to this proposed rule.
In the spirit of the Order, and
consistent with EPA policy to promote
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Fmt 4702
Sfmt 4702
4607
communications between the Agency
and State and local governments, EPA
specifically solicits comment on this
proposed rule from tribal officials.
G. Children’s Health
EPA interprets Executive Order
13045, entitled Protection of Children
from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23,
1997), as applying only to those
regulatory actions that concern health or
safety risks, such that the analysis
required under section 5–501 of
Executive Order 13045 has the potential
to influence the regulation. This action
is not subject to Executive Order 13045
because it does not establish an
environmental standard intended to
mitigate health or safety risks, and it is
not designated as an ‘‘economically
significant’’ regulatory action as defined
by Executive Order 12866 (see Unit
V.A.). To the contrary, this action will
provide added protection for children
from pesticide risk.
H. Energy Effects
This action is not a ‘‘significant energy
action’’ as defined in Executive Order
13211, entitled Actions Concerning
Regulations that Significantly Affect
Energy Supply, Distribution, or Use (66
FR 28355, May 22, 2001), because it is
not likely to have an effect on the
supply, distribution, or use of energy as
described in the Order.
I. Technical Standards
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (NTTAA), 15 U.S.C. 272
note, directs EPA to use voluntary
consensus standards in its regulatory
activities unless to do so would be
inconsistent with applicable law or
impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
and sampling procedures) that are
developed or adopted by voluntary
consensus standards bodies. NTTAA
directs EPA to provide Congress,
through OMB, explanations when the
Agency decides not to use available and
applicable voluntary consensus
standards.
This action does not propose to
require any technical standards that
would require Agency consideration of
voluntary consensus standards. This
action proposes the types of data to be
required to support the registration of
antimicrobial pesticide products with
prion-related claims but does not
propose to require specific methods or
standards to generate those data.
The Agency invites comment on its
conclusion regarding the applicability of
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voluntary consensus standards to this
proposed rulemaking.
J. Environmental Justice
This proposed rule does not have an
adverse impact on the environmental
and health conditions in low-income
and minority communities. Therefore,
under Executive Order 12898, entitled
Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations (59 FR 7629, February 16,
1994), the Agency does not need to
consider environmental justice-related
issues.
VI. References
As indicated under ADDRESSES, a
docket has been established for this
rulemaking under docket ID number
EPA–HQ–OPP–2010–0427. 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 in developing this
proposed rule, 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 listed under FOR FURTHER
INFORMATION CONTACT.
mstockstill on DSKH9S0YB1PROD with PROPOSALS
1. U.S. Environmental Protection Agency.
2004. Considerations of Prions as a Pest
under FIFRA. Memorandum to The Record
from Susan B. Hazen, Principal Deputy
Assistant Administrator, Office of
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17:13 Jan 25, 2011
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Prevention, Pesticides, and Toxic Substances.
April 29, 2004.
2. U.S. Environmental Protection Agency.
2009. ‘‘Scientific Information Concerning the
Issue of Whether Prions Are a ‘Pest’ under
the Federal Insecticide, Fungicide, and
Rodenticide Act.’’ Draft dated February 23,
2009.
3. U.S. Environmental Protection Agency.
2009. Transmittal of Meeting Minutes of the
FIFRA Scientific Advisory Panel Meeting
Held March 31–April 1, 2009 on Scientific
Issues Associated with Designating a Prion as
a ‘Pest’ under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), and
Related Efficacy Test Methods. Memorandum
from Myrta R. Christian, Designated Federal
Official, FIFRA Scientific Advisory Panel,
Office of Science Coordination and Policy, to
Debbie Edwards, PhD, Director, Office of
Pesticide Programs. June 29, 2009. See
https://www.epa.gov/scipoly/sap/meetings/
2009/march/033109panelmembers.html.
4. U.S. Environmental Protection Agency.
2010. EPA Responses to Comments by the
FIFRA Scientific Advisory Panel Concerning
‘‘Scientific Information Concerning the Issue
of Whether Prions Are a ‘Pest’ under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA).’’ February 17, 2010.
5. U.S. Environmental Protection Agency.
2010. Scientific Information Concerning the
Issue of Whether A Prion Is a ‘‘Pest’’ under
the Federal Insecticide, Fungicide, and
Rodenticide Act. February 17, 2010.
6. U.S. Environmental Protection Agency.
2009. Product Performance Test Guidelines
OPPTS 810.XXXX Products with Prion
Related Claims. Draft dated February 23,
2009.
7. U.S. Environmental Protection Agency.
2009. Product Performance Test Guidelines
OPPTS 810.XXXX Products with Prion
Related Claims. Draft dated December 8,
2009.
PO 00000
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Fmt 4702
Sfmt 9990
8. U.S. Environmental Protection Agency.
2010. Economic Analysis of the Notice of
Proposed Rulemaking Concerning that Status
of a Prion as a Pest under the Federal
Insecticide, Fungicide, and Rodenticide Act
(FIFRA). February 17, 2010.
List of Subjects in 40 CFR Part 152
Environmental protection,
Antimicrobial pesticides, Prion.
Dated: January 14, 2011.
Lisa P. Jackson,
Administrator.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
PART 152—[AMENDED]
1. The authority citation for part 152
continues to read as follows:
Authority: 7 U.S.C. 136–136y; subpart U
is also issued under 31 U.S.C. 9701.
2. Section 152.5 is amended by
revising paragraph (d) to read as
follows:
§ 152.5
Pests.
*
*
*
*
*
(d) Any fungus, bacterium, virus,
prion, or other microorganism, except
for those on or in living man or other
living animals and those on or in
processed food or processed animal
feed, beverages, drugs (as defined in
FFDCA section 201(g)(1)) and cosmetics
(as defined in FFDCA section 201(i)).
[FR Doc. 2011–1636 Filed 1–25–11; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 76, Number 17 (Wednesday, January 26, 2011)]
[Proposed Rules]
[Pages 4602-4608]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1636]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 152
[EPA-HQ-OPP-2010-0427; FRL-8850-4]
RIN 2070-AJ26
Declaration of Prion as a Pest Under FIFRA and Amendment of EPA's
Regulatory Definition of Pests To Include Prion
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA proposes to declare a prion (i.e., proteinaceous
infectious particle) a ``pest'' under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), and to amend its regulations to
expressly include prion within the regulatory definition of pest. EPA
currently considers a prion to be a pest under FIFRA, so a product
intended to reduce the infectivity of any prion on inanimate surfaces
(i.e., a ``prion-related product'') is considered to be a pesticide and
regulated as such. Any company seeking to distribute or sell a
pesticide product regulated under FIFRA must obtain a section 3
registration, section 24(c) registration, or a section 18 emergency
exemption before it can be distributed or sold in the United States.
This proposed rule would codify the Agency's current interpretation of
FIFRA, and provides interested parties the opportunity to comment about
how it is adding prion to the list of pests in the regulatory
definition of pest. This amendment, together with the formal
declaration that a prion is a pest, will eliminate any confusion about
the status of prion-related products under FIFRA. Codifying the
Agency's current interpretation of FIFRA will not change the manner in
which EPA currently regulates prion-related products under FIFRA
sections 3, 24(c) and 18. Regulating prion-related products under FIFRA
is appropriate for protecting human health and the environment against
unreasonable adverse effects and ensuring that such products are
effective.
DATES: Comments must be received on or before March 28, 2011.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0427, by one of the following methods:
Federal eRulemaking Portal: https://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-
2010-0427. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://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 website 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
[[Page 4603]]
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 https://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 https://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: Jeff Kempter, Antimicrobials Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5448; fax number: (703) 308-6467; e-mail address:
kempter.carlton@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you apply for or
own pesticide registrations. Potentially affected entities may include,
but are not limited to:
Producers of pesticide products (NAICS code 32532).
Producers of antimicrobial pesticides (NAICS code 32561).
Veterinary testing laboratories (NAICS code 541940).
Medical pathology laboratories (NAICS code 621511).
Taxidermists, independent (NAICS code 711510).
Surgeons (NAICS code 621111).
Dental surgeons (NAICS code 621210).
Mortician services (NAICS code 812210).
Manufacturers of medical tissue devices of human and
animal origin (NAICS code undetermined).
Manufacturers of other human cellular and tissue products
(NAICS code undetermined).
Organ banks, body (NAICS code 621991).
Plasma, blood, merchant wholesalers (NAICS code 424210).
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 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.
B. 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, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What action is the Agency taking?
EPA has decided that under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) a prion is considered to be a pest, and
proposes to declare a prion to be a pest and to explicitly include it
in the lists of pests in 40 CFR 152.5. These actions would affirm the
Agency's authority to regulate products distributed or sold for the
purpose of reducing the infectivity of prions on inanimate surfaces
(i.e., prion-related products). Prion-related products are currently
regulated under FIFRA and subject to all requirements and provisions of
the Act based on EPA's September 10, 2003 decision that prions share
enough characteristics of an ``other micro-organism'' or ``form of
life'' (as those terms are used in FIFRA) to fall within the scope of
FIFRA section 2(t) and 40 CFR 152.5(d). This proposal ensures that the
regulatory definition reflects the Agency's authority to regulate
products distributed or sold for the purpose of reducing the
infectivity of prions on inanimate surfaces (i.e., prion-related
products). The primary impact of declaring that a prion is a pest and
including ``prion'' in the regulatory definition of ``pest'' is to
provide regulatory clarity that prion-related products must be
registered or exempted under FIFRA sections 3, 24(c), or 18 before such
products may be distributed or sold in the United States.
Note that not all prions and prion-related products are affected by
the proposed rule. Firstly, EPA's regulations at 40 CFR 152.5(d)
exclude pests ``* * * in or on living man or other living animals and
those on or in processed food or processed animal feed, beverages,
drugs * * * and cosmetics.'' Therefore, the proposed rule would not
apply to those uses of prion-related products. Secondly, the definition
of ``pesticide'' in FIFRA section 2(u) excludes new animal drugs and
liquid chemical sterilants intended for use on a critical or semi-
critical device. Accordingly, products which fall into those categories
would not be covered by the proposed rule.
[[Page 4604]]
B. What is the Agency's authority for taking this action?
This action is issued under the authority of sections 2 through 34
of FIFRA (7 U.S.C. 136-136y).
III. Prion as a Pest Under FIFRA
A. What is a prion?
Prions (``proteinaceous infectious particles'') may occur in the
central nervous system tissues of animals as an abnormal
(``misfolded''), infectious form of prion protein. Prion protein in its
normal form, or conformation, can be designated PrP\c\ (``cellular''
isoform) while abnormal conformations of prion proteins are generally
called prions. Different types of prions are commonly designated by the
type of diseases they produce, such as PrP\Sc\ (prions associated with
scrapie) and PrP\BSE\ (prions associated with bovine spongiform
encephalopathy--mad cow disease).
In the disease process, prions (such as PrP\sc\) recruit normal
prion proteins (PrP\c\) and convert them into prions (e.g., another
copy of PrP\Sc\). This recruitment and conversion process results in
the progressive accumulation of disease-producing prions. When this
process takes place in the brain, it causes disease that slowly
progresses from neuronal dysfunction and degeneration to death. These
neurodegenerative prion diseases are known collectively as
transmissible spongiform encephalopathies (TSEs). TSEs include scrapie
disease in sheep, bovine spongiform encephalopathy (BSE) in cattle,
chronic wasting disease (CWD) in deer and elk, kuru and variant
Creutzfeld-Jakob Disease (vCJD) in humans, and similar diseases in
other animals. EPA and other agencies are concerned that animal-related
prions may spread to other animals (e.g., scrapie to sheep, CWD to
cervids) or to humans (e.g., BSE), and that human-related prions may be
passed to other humans (e.g., kuru or CJD). These diseases are always
fatal in humans and animals alike, and there are no known treatments or
cures.
B. Legal/Regulatory Background
Under section 25(c)(1) of FIFRA, the Administrator, after notice
and opportunity for hearing, is authorized ``to declare a pest any form
of plant or animal life (other than man and other than bacteria, virus,
and other micro-organisms on or in living man or other living animals)
which is injurious to health or the environment.'' Therefore, the
Agency has the authority to decide whether or not a prion should be
considered to be a pest under FIFRA and whether to issue a regulation
implementing that decision.
On September 10, 2003, the EPA decided that a prion should be
considered to be a ``pest'' under FIFRA and that products intended to
inactivate prions (i.e., ``prion-related products'') should be
regulated under FIFRA (Ref. 1). This decision was made partly in
connection with the widespread occurrence of chronic wasting disease
(CWD) among deer and elk in a number of states, particularly in the
Rocky Mountain region. Although CWD had been endemic to that region for
a long time, concerns were growing inside and outside of EPA as to how
to prevent or minimize the movement of what is believed to be the
causative agent for CWD--prions--through the environment.
At the same time, EPA was receiving inquiries from states about
obtaining FIFRA section 18 exemptions to allow use of a disinfectant
against prions on inanimate surfaces in government and commercial
laboratories. EPA was also aware that the World Health Organization
(WHO) recommended the use of sodium hydroxide or sodium hypochlorite
for treating surfaces potentially contaminated with prions even though
those chemicals were not registered by EPA for that specific purpose.
Subsequent to the September 2003 decision, EPA has granted a total of
19 quarantine exemptions under FIFRA section 18 to numerous states
(California, Colorado, Maine, Minnesota, Montana, North Dakota, South
Dakota, Utah, and Wyoming) and the U.S. Department of Agriculture
(USDA) for the use of a commercial aqueous acid phenolic product,
Environ LpH, for treatment on hard, nonporous surfaces in government
and commercial laboratories contaminated with CWD and other kinds of
prions.
Other Federal agencies are responsible for implementing controls to
prevent the spread of prion diseases to animals and humans. For
example, to eliminate scrapie within the United States, USDA's Animal
and Plant Health Inspection Service (APHIS) administers the national
scrapie eradication program (9 CFR parts 54 and 79). APHIS also intends
to establish a herd certification program to prevent and control CWD
from farmed or captive cervids in the United States (9 CFR parts 55 and
81). In addition, APHIS regulates the importation of animals and animal
products into the United States to guard against the introduction of
various animal diseases, including BSE (9 CFR parts 92, 93, 94, and
95). To prevent the spread of BSE through animal feed, the Food & Drug
Administration (FDA) prohibits the use of most mammalian protein in the
manufacture of animal feed used for ruminants and prohibits high risk
cattle materials from all animal feed (21 CFR part 589). To prevent
potential human exposure to the BSE agent, USDA's Food Safety and
Inspection Service prohibits for use as human food cattle materials
that could potentially contain the BSE agent (9 CFR 310.22). FDA has
also issued an interim final rule (69 FR 42256, July 14, 2004)
prohibiting the use of certain cattle materials in human food and
cosmetics to address the potential risk of BSE (21 CFR 189.5 and
700.27).
C. EPA's Interpretation of FIFRA
1. Applicable FIFRA provisions. FIFRA section 25(c)(1) authorizes
the Administrator ``to declare a pest any form of plant or animal life
(other than man and other than bacteria, virus, and other micro-
organisms on or in living man or other living animals) which is
injurious to health or the environment.'' FIFRA section 2(t) defines a
pest, in part, as ``* * * any other form of terrestrial or aquatic
plant or animal life or virus, bacteria or other micro-organism * * *
which the Administrator declares to be a pest under section 25(c)(1).''
These FIFRA sections provide EPA the authority to declare an entity to
be a ``pest'' if it meets these statutory provisions.
2. EPA's interpretation of FIFRA. EPA's decision to declare a prion
to be a pest under FIFRA rests on its statutory interpretation of FIFRA
sections 25(c)(1) and 2(t). EPA believes that Congress intended that
the phrases ``any other form of plant or animal life'' and ``other
micro-organism'' be broadly interpreted to include biological entities
that are injurious to humans or the environment. The following points
provide EPA's rationale for this interpretation.
In FIFRA, Congress has over the years used the term
``other micro-organism'' more broadly than most microbiologists
currently would define the term because, as used in FIFRA, the term
``micro-organism'' includes viruses, which many microbiologists do not
consider to be microorganisms. Therefore, the term ``micro-organism,''
as currently defined by many microbiologists, is narrower than the
potential scope of the term ``other micro-organism'' in FIFRA.
As used in FIFRA, the term ``other micro-organism''
includes entities other than viruses and bacteria, but it is unclear
which entities. It is reasonable to assume that it includes those
entities that most microbiologists currently recognize as
microorganisms (i.e., microfungi, yeasts, and protists).
[[Page 4605]]
Because the statutory language explicitly includes viruses among micro-
organisms in the definition of ``pest,'' the term ``other micro-
organism'' in its statutory context reasonably may be interpreted to
include some other entities that many microbiologists may not
categorize as microorganisms.
Today, microbiologists do not generally classify viruses
as microorganisms because they are not alive (i.e., they cannot
reproduce sexually or asexually, grow or perform self-maintenance).
Therefore, the term ``other micro-organism'' as used in FIFRA appears
broad enough to include some entities that are not alive.
Congress' rationale for including viruses within the FIFRA
definition of ``pest'' is not known as there is no available
legislative history on this issue. However, it is reasonable to infer
that Congress included viruses within the FIFRA definition of ``pest''
and within the scope of the meaning of ``micro-organism'' because
viruses share important characteristics of other pests. The
characteristics of a virus that make it resemble a micro-organism in
the context of ``pest'' are pathogenicity, infectivity,
transmissibility, the ability to increase in number, and the ability to
evolve. EPA believes that Congress intended the terms ``pest'' and
``other micro-organism'' as used in FIFRA to be broadly inclusive.
One entity that shares the characteristics of
pathogenicity, infectivity, transmissibility, the ability to increase
in number, and the ability to evolve (but which, like viruses, is not
alive) is the prion. A prion is an infectious agent occurring in the
tissues of animals that is widely, though not universally, believed to
be composed of an abnormal (misfolded) protein without nucleic acid.
Prions are also unquestionably injurious to the health of humans and
other animals. They cause TSE diseases that attack the nervous system,
inflict irreversible damage, and are always fatal to infected animals
and humans. Once introduced into an animal or human host, prions can
induce the formation of new prions in the animal or human host. Prions
are considered among the most difficult of all biological entities to
mitigate and few methods are available for effectively doing so.
Moreover, current test methods cannot demonstrate complete destruction
or inactivation of prions. For these reasons, EPA believes that the
public needs assurance of the safety and efficacy of products intended
to reduce the infectivity of prions.
Congress expressly included ``prion'' within another
statute's definition of ``pest,'' namely in the Animal Health
Protection Act of 2002.
For these reasons, EPA concluded that a prion is appropriately
included in the phrase ``other micro-organism.'' Because prions are
also severely injurious to human and animal health, EPA has also
concluded that a prion is appropriately included in the FIFRA
definition of ``pest.''
D. EPA's Prion Science Evaluation and Efficacy Test Guidance Documents
To assure that this rulemaking is based on the best available
scientific information, EPA reviewed and summarized the most relevant
scientific studies and publications related to the issue of whether a
prion is a pest in a ``white paper'' (Ref. 2). EPA presented the draft
white paper to the FIFRA Scientific Advisory Panel (SAP) for peer
review and comment on March 31 and April 1, 2009. The SAP provided
comments to EPA on the draft white paper on June 29, 2009 (Ref. 3). EPA
subsequently responded to the SAP's comments (Ref. 4) and made
revisions to the white paper in response to the SAP comments (Ref. 5).
All of these referenced documents are available in the docket for this
declaration and proposed rule.
IV. FIFRA Review Requirements
In accordance with FIFRA section 25(a), EPA has submitted a draft
of the proposed rule to the FIFRA SAP, the Secretary of Agriculture
(USDA), and appropriate Congressional Committees. In addition, pursuant
to FIFRA section 21(b), EPA submitted a draft of the proposed rule to
the Secretary of Health and Human Services (HHS).
The FIFRA SAP waived its review of this proposal on June 1, 2010,
because the significant scientific issues involved have already been
reviewed by the SAP and additional review is not necessary. A copy of
this waiver is available in the docket.
As required by FIFRA section 25(a), the written comments on the
draft proposal received from USDA and HHS, along with EPA responses,
are available in the docket. EPA addressed these comments as part of
the interagency review process under Executive Order 12866, and changes
made to the proposed rule in response to all comments received during
that interagency review are documented in the docket as required by
Executive Order 12866.
V. Statutory and Executive Order Reviews
A. Regulatory Review
Pursuant to Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that this proposed rule is a ``significant
regulatory action'' because this action might raise novel legal or
policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order.
Accordingly, EPA submitted this proposed rulemaking to OMB for review
under Executive Order 12866. Any changes made in response to OMB
comments have been documented in the docket for this rulemaking as
required by the Executive Order.
EPA has prepared an economic analysis of the potential costs
associated with this proposed action, entitled Economic Analysis of the
Notice of Proposed Rulemaking Concerning the Status of Prion as a Pest
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
(Ref. 8). A copy of this document is available in the docket for this
rulemaking, and is briefly summarized here.
The Economic Analysis (EA) presents the Agency's assessment of the
potential costs and benefits expected to result from the proposed rule.
In terms of benefits, the proposed rule will ensure that EPA can
protect human health and the environment by subjecting prion-related
products to regulation under FIFRA, including all data and labeling
requirements. In terms of costs, using pre-2003 costs as the baseline,
the incremental costs of the proposed rule per registration action
range from $424,000 to $4.72 million.
The EA presents the costs of various types of registrations under
the proposed rule and presents expected incremental costs for three
product registration types. The three types of registration actions
which are possible under the proposed rule are the registration of: (1)
A new active ingredient, (2) a new use product, or (3) a new use
amendment registration.
The EA estimates that three firms may seek registrations for major
new use products in the first year. If all uses are high exposure
(e.g., indirect food uses), the maximum potential total cost to
industry in the first year would be approximately $7.05 million, and
costs per firm would be approximately $2.35 million. Given the
uncertainty that characterizes the market for prion-related products at
this time, the Agency did not speculate further on the
[[Page 4606]]
expected number of registrations in subsequent years. However,
registrations that occur after the initial major new use product
registrations would probably be major new use amendments. Data
requirements would entail only product-specific efficacy data for major
new use amendments at a cost of approximately $431,000 per registration
action. Approximately 80% of the firms in the pesticide manufacturing
industry are small firms with revenues of $22 million, on average. A
cost of $7.05 million suggests that the incremental cost per firm of
$2.35 million dollars would equal nearly 11% of annual revenues.
However, after the initial three registrations, a major new use
amendment at a cost of $431,000 would represent fewer than 2% of
average annual revenues.
The EA identifies three categories of persons who could be affected
by the proposed rule--pesticide registrants, users of prion-related
products, and researchers. The registration related requirements under
FIFRA, however, are imposed on the entity that registers the prion-
related product. Users of prion-related products and researchers are
affected indirectly. The EA summarizes potential qualitative impacts of
regulating prion-related products that were expressed by product users
to EPA during its outreach efforts to these users.
The EA evaluates the impacts of the data required to support the
registration of a prion-related product, specifically the need for a
product performance test that will measure the ability of an individual
product to reduce the infectivity of prions. The Agency has developed
draft test guidelines for prions which will ensure that the Agency
receives the data needed to make objective and reliable determinations
as to whether a prion-related product meets the Agency's efficacy data
requirements for registration. Providing clear guidance on EPA's
efficacy data requirements for prion-related products will benefit
registrants by enabling them to submit relevant, correct and complete
data submissions in support of applications for registration to the
Agency.
One unintended consequence of using products approved for use under
FIFRA section 18 exemptions is that at least one state, California,
requires that such products be applied only by certified applicators.
EPA further understands, however, that California has no such
requirement for pesticide products that are registered under FIFRA
section 3 or 24(c) that are not classified for restricted use. Hence,
laboratories in California that use prion-related products registered
under section 3 or 24(c) would not be subject to a certified applicator
requirement. The initial cost of obtaining the certified applicator's
license in California is $140, and the renewal fee is $60 every 2 years
(see https://www.cdpr.ca.gov/docs/license/qac.htm). In addition, 20
hours of continuing education is required to obtain renewal. If a
similar requirement is imposed by other states, the cost to
laboratories for obtaining applicator licenses would probably be about
the same. No such cost is associated with products registered under
section 3 or 24(c).
B. Paperwork Activities
The information collection requirements, i.e., the paperwork
collection activities, contained in this proposal are already approved
by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq.
Specifically, the activities contained in this proposed rule are
already addressed in the following information collection requests
(ICRs):
1. The activities associated with the establishment of a tolerance
are currently approved under OMB Control No. 2070-0024 (EPA ICR No.
0597).
2. The activities associated with the application for a new or
amended registration of a pesticide are currently approved under OMB
Control No. 2070-0060 (EPA ICR No. 0277).
3. The activities associated with the generation of data in
response to a Data-Call-In issued subsequent to registration (e.g., as
part of the review of an existing registration), are currently approved
under OMB Control No. 2070-0174 (EPA ICR No. 2288).
The existing ICRs cover the paperwork activities contained in this
proposal because the activities already occur as part of existing
program activities. These program activities are an integral part of
the Agency pesticide program and the corresponding ICRs are regularly
renewed. Although this proposal involves already approved activities,
the estimated frequency of those activities may increase as a result of
this proposal. The total estimated average annual public reporting
burden currently approved by OMB for these various activities ranges
from approximately 8 hours to 3,000 hours per respondent, depending on
the activity and other factors surrounding the particular pesticide
product. According to EPA's EA for this proposed rule (Ref. 8), using
the estimate of three major new use product registrations in the first
year, the additional registration of three antimicrobial products
making prion-related claims will result in an increase in new
registration applications for the Agency from 140 to 143 and an
increase in tolerance petitions of from 64 to 67. The increase in
paperwork burden for the registrant will be nearly $38,000 (600 hours
for three registrations) for registration activities and a little more
than $423,000 (5,200 hours for three registrations) for paperwork for
tolerance petitions (Ref. 8).
An agency may not conduct or sponsor, and a person is not required
to respond to an information collection request unless it displays a
currently valid OMB control number, or is otherwise required to submit
the specific information by a statute. The OMB control numbers for
EPA's regulations, after appearing in the preamble of the final rule,
are listed in 40 CFR part 9 and 48 CFR chapter 15, and included on the
related collection instrument (e.g., form or survey).
Under the PRA, ``burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
Comments are requested on the Agency's need for this information,
the accuracy of the burden estimates, and any suggested methods for
minimizing respondent burden, including through the use of automated
collection techniques. Send comments to EPA as part of your overall
comments on this proposed action in the manner specified under
ADDRESSES. In the final rule, the Agency will address any comments
received regarding the information collection requirements contained in
this proposed rule.
C. Small Entity Impacts
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., after considering the potential economic impacts
of this proposed rule on small entities, I hereby certify that this
proposed rule would not have a significant adverse economic impact on a
substantial number of small
[[Page 4607]]
entities. This determination is based on the Agency's economic analysis
(Ref. 8), and is briefly summarized here.
Under the RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. For purposes of
assessing the impacts of today's proposed rule on small entities, small
entity is defined as: (1) A small business as defined by the Small
Business Administration's (SBA) regulations at 13 CFR 121.201 (in this
case based on maximum number of employees or sales for small businesses
in each industry sector, as defined by a 6-digit NAICS code); (2) a
small governmental jurisdiction that is a government of a city, county,
town, school district or special district with a population of less
than 50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field. Since the regulated community does not include
small governmental jurisdictions or small not-for-profit organizations,
the analysis focuses on small businesses.
According to the Agency's economic analysis (Ref. 8), only three
firms are expected to apply for registrations of prion-related
products. One of these firms is known to be a large firm. Given that
approximately 79% of the firms in the antimicrobial industry are small
firms, it is possible that any or all of the remaining two other firms
could qualify as a small entity under the SBA definition.
The incremental costs of the proposed rule could represent from 2%
to 11% of the average annual revenues of a small firm. In general, the
Agency does not believe that prion-related products are an important
market segment for sodium hydroxide or sodium hypochlorite producing
firms and does not anticipate a large number of product registrations
beyond the first year the final rule would take effect. If small
entities apply to register products for prion control, they would
likely pursue a registration where they could likely cite a substantial
amount of data and not incur 100% of the initial costs of testing (Ref.
8).
EPA continues to be interested in the potential impacts of this
proposed rule on small entities and welcomes comments on issues related
to such impacts.
D. Unfunded Mandates
This action does not contain any Federal mandates for State, local,
or tribal governments or the private sector under the provisions of
Title II of the Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1531-
1538. EPA has determined that this regulatory action will not result in
annual expenditures of $100 million or more for State, local, and
tribal governments, in the aggregate, or for the private sector. As
described in Unit IV.A., the incremental costs for the proposed rule
are estimated from $424,000 to $4.72 million. Since State, local, and
tribal governments are rarely pesticide applicants, the proposed rule
is not expected to significantly or uniquely affect small governments.
As such, EPA has determined that this action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
affect on small governments. Accordingly, this action is not subject to
the requirements of sections 202, 203 or 205 of UMRA.
E. Federalism Implications
Pursuant to Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999), EPA has determined that this proposed rule
does not have ``federalism implications'' because it will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government, as
specified in the Order. As indicated previously, instances where a
state is a registrant are extremely rare. Therefore, this proposed rule
may seldom affect a state government. Thus, Executive Order 13132 does
not apply to this proposed rule.
In the spirit of the Order, and consistent with EPA policy to
promote communications between the Agency and State and local
governments, EPA specifically solicits comment on this proposed rule
from State and local officials.
F. Tribal Implications
As required by Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000), EPA has determined that this proposed rule does not have
``tribal implications'' because it will not have substantial direct
effects on tribal governments, on the relationship between the Federal
government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes, as
specified in the Order. As indicated previously, at present, no tribal
governments hold, or have applied for, a pesticide registration. Thus,
Executive Order 13175 does not apply to this proposed rule.
In the spirit of the Order, and consistent with EPA policy to
promote communications between the Agency and State and local
governments, EPA specifically solicits comment on this proposed rule
from tribal officials.
G. Children's Health
EPA interprets Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997), as applying only to those regulatory actions that
concern health or safety risks, such that the analysis required under
section 5-501 of Executive Order 13045 has the potential to influence
the regulation. This action is not subject to Executive Order 13045
because it does not establish an environmental standard intended to
mitigate health or safety risks, and it is not designated as an
``economically significant'' regulatory action as defined by Executive
Order 12866 (see Unit V.A.). To the contrary, this action will provide
added protection for children from pesticide risk.
H. Energy Effects
This action is not a ``significant energy action'' as defined in
Executive Order 13211, entitled Actions Concerning Regulations that
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001), because it is not likely to have an effect on the
supply, distribution, or use of energy as described in the Order.
I. Technical Standards
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), 15 U.S.C. 272 note, directs EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or impractical. Voluntary consensus
standards are technical standards (e.g., materials specifications, test
methods, and sampling procedures) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
This action does not propose to require any technical standards
that would require Agency consideration of voluntary consensus
standards. This action proposes the types of data to be required to
support the registration of antimicrobial pesticide products with
prion-related claims but does not propose to require specific methods
or standards to generate those data.
The Agency invites comment on its conclusion regarding the
applicability of
[[Page 4608]]
voluntary consensus standards to this proposed rulemaking.
J. Environmental Justice
This proposed rule does not have an adverse impact on the
environmental and health conditions in low-income and minority
communities. Therefore, under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994), the Agency does
not need to consider environmental justice-related issues.
VI. References
As indicated under ADDRESSES, a docket has been established for
this rulemaking under docket ID number EPA-HQ-OPP-2010-0427. 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 in developing this proposed rule,
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 listed under FOR
FURTHER INFORMATION CONTACT.
1. U.S. Environmental Protection Agency. 2004. Considerations of
Prions as a Pest under FIFRA. Memorandum to The Record from Susan B.
Hazen, Principal Deputy Assistant Administrator, Office of
Prevention, Pesticides, and Toxic Substances. April 29, 2004.
2. U.S. Environmental Protection Agency. 2009. ``Scientific
Information Concerning the Issue of Whether Prions Are a `Pest'
under the Federal Insecticide, Fungicide, and Rodenticide Act.''
Draft dated February 23, 2009.
3. U.S. Environmental Protection Agency. 2009. Transmittal of
Meeting Minutes of the FIFRA Scientific Advisory Panel Meeting Held
March 31-April 1, 2009 on Scientific Issues Associated with
Designating a Prion as a `Pest' under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test
Methods. Memorandum from Myrta R. Christian, Designated Federal
Official, FIFRA Scientific Advisory Panel, Office of Science
Coordination and Policy, to Debbie Edwards, PhD, Director, Office of
Pesticide Programs. June 29, 2009. See https://www.epa.gov/scipoly/sap/meetings/2009/march/033109panelmembers.html.
4. U.S. Environmental Protection Agency. 2010. EPA Responses to
Comments by the FIFRA Scientific Advisory Panel Concerning
``Scientific Information Concerning the Issue of Whether Prions Are
a `Pest' under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA).'' February 17, 2010.
5. U.S. Environmental Protection Agency. 2010. Scientific
Information Concerning the Issue of Whether A Prion Is a ``Pest''
under the Federal Insecticide, Fungicide, and Rodenticide Act.
February 17, 2010.
6. U.S. Environmental Protection Agency. 2009. Product
Performance Test Guidelines OPPTS 810.XXXX Products with Prion
Related Claims. Draft dated February 23, 2009.
7. U.S. Environmental Protection Agency. 2009. Product
Performance Test Guidelines OPPTS 810.XXXX Products with Prion
Related Claims. Draft dated December 8, 2009.
8. U.S. Environmental Protection Agency. 2010. Economic Analysis
of the Notice of Proposed Rulemaking Concerning that Status of a
Prion as a Pest under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). February 17, 2010.
List of Subjects in 40 CFR Part 152
Environmental protection, Antimicrobial pesticides, Prion.
Dated: January 14, 2011.
Lisa P. Jackson,
Administrator.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 152--[AMENDED]
1. The authority citation for part 152 continues to read as
follows:
Authority: 7 U.S.C. 136-136y; subpart U is also issued under 31
U.S.C. 9701.
2. Section 152.5 is amended by revising paragraph (d) to read as
follows:
Sec. 152.5 Pests.
* * * * *
(d) Any fungus, bacterium, virus, prion, or other microorganism,
except for those on or in living man or other living animals and those
on or in processed food or processed animal feed, beverages, drugs (as
defined in FFDCA section 201(g)(1)) and cosmetics (as defined in FFDCA
section 201(i)).
[FR Doc. 2011-1636 Filed 1-25-11; 8:45 am]
BILLING CODE 6560-50-P