4602 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 

A. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through http:// 

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. 

• 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 http:// 

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 

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 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: 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 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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Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Proposed Rules 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., 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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4604 Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Proposed Rules 

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 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 

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 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 

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 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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4606 Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Proposed Rules 

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 

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 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 

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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Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Proposed Rules 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-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 

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 

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4608 Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Proposed Rules 

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: 

§ 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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