[Federal Register Volume 76, Number 17 (Wednesday, January 26, 2011)]
[Proposed Rules]
[Pages 4602-4608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1636]
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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.
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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: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0427. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov 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 http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: 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:
[email protected].
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 http://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 http://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