Document ID: EPA-HQ-OPP-2010-0427-0002
Agency: epa
Document Type: Proposed Rule
Title: Declaration of Prion as a Pest and Amendment of Regulatory Definition of Pests to Include Prion
Posted Date: 2011-01-26T05:00Z

[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]

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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: 
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 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