71294 Federal Register / Vol. 76, No. 222 / Thursday, November 17, 2011 / Proposed Rules 

individual or to granting access to an 

investigative file pertaining to such 

individual could: 

(i) Interfere with investigative and 

enforcement proceedings, 

(ii) Deprive codefendants of a right to 

a fair trial or an impartial adjudication, 

(iii) Constitute an unwarranted 

invasion of the personal privacy of 

others, 

(iv) Disclose the identity of 

confidential sources and reveal 

confidential information supplied by 

such sources, 

(v) Disclose investigative techniques 

and procedures. 

(3) 5 U.S.C. 552a(e)(1). This provision 

of the Privacy Act requires each agency 

to maintain in its records only such 

information about an individual as is 

relevant and necessary to accomplish a 

purpose of the agency required to be 

accomplished by statute or executive 

order. The reasons for exempting this 

system of records from the foregoing are 

as follows: 

(i) The IRS will limit the system to 

those records that are needed for 

compliance with the provisions of Title 

26, 31 U.S.C. 330, and regulations 

applicable to paid tax return preparers. 

However, an exemption from the 

foregoing is needed because, 

particularly in the early stages of an 

investigation, it is not possible to 

determine the relevance or necessity of 

specific information. 

(ii) Relevance and necessity are 

questions of judgment and timing. What 

appears relevant and necessary when 

first received may subsequently be 

determined to be irrelevant or 

unnecessary. It is only after the 

information is evaluated that the 

relevance and necessity of such 

information can be established with 

certainty. 

(5) 5 U.S.C. 552a(e)(4)(I). This 

provision of the Privacy Act requires the 

publication of the categories of sources 

of records in each system of records. 

The reasons an exemption from this 

provision has been claimed, are as 

follows: 

(i) Revealing categories of sources of 

information could disclose investigative 

techniques and procedures. 

(ii) Revealing categories of sources of 

information could cause sources who 

supply information to investigators to 

refrain from giving such information 

because of fear of reprisal, or fear of 

breach of promises of anonymity and 

confidentiality. 

Treasury will publish the notice of the 

proposed new system of records 

separately in the Federal Register. 

Pursuant to Executive Order 12866, it 

has been determined that this proposed 

rule is not a significant regulatory 

action, and therefore, does not require a 

regulatory impact analysis. Because no 

notice of proposed rulemaking is 

required, the provisions of the 

Regulatory Flexibility Act, 5 U.S.C. 601– 

612, do not apply. 

The regulation will not have a 

substantial direct effect on the States, on 

the relationship between the Federal 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Therefore, it is 

determined that this proposed rule does 

not have federalism implications under 

Executive Order 13132. 

Pursuant to the requirements of the 

Regulatory Flexibility Act, 5 U.S.C. 601– 

612, it is hereby certified that these 

regulations will not significantly affect a 

substantial number of small entities. 

The proposed rule imposes no duties or 

obligations on small entities. 

List of Subjects in 31 CFR Part 1 

Privacy. 

Part 1, subpart C of title 31 of the 

Code of Federal Regulations is amended 

as follows: 

PART 1—[AMENDED] 

1. The authority citation for part 1 

continues to read as follows: 

Authority: 5 U.S.C. 301 and 31 U.S.C. 321. 

Subpart A also issued under 5 U.S.C. 552 as 

amended. Subpart C also issued under 5 

U.S.C. 552a. 

2. Section 1.36 paragraph (g)(1)(viii) is 

amended by adding the following text to 

the table in numerical order. 

§ 1.36 Systems exempt in whole or in part 

from provisions of 5 U.S.C. 552a and this 

part. 

(g) * * * 

(1) * * * 

(viii) * * * 

Number Name of system 

* * * * * 

IRS 37.111 ....... Preparer Tax Identification 

Number Records. 

* * * * * 

Dated: October 24, 2011. 

Melissa Hartman, 

Deputy Assistant Secretary for Privacy, 

Transparency, and Records. 

[FR Doc. 2011–29384 Filed 11–16–11; 8:45 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 158 and 161 

[EPA–HQ–OPP–2010–0427; FRL–8886–1] 

RIN 2070–AJ26 

Prions; Proposed Amendment To 

Clarify Product Performance Data for 

Products With Prion-Related Claims 

and Availability of Draft Test 

Guidelines 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Supplemental proposed rule. 

SUMMARY: As a supplement to the 

proposed rule 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 is 

now proposing to amend its product 

performance data requirements to 

clarify that efficacy data are required for 

all products with prion-related claims. 

The existing product performance data 

requirements already require efficacy 

data to be submitted when the 

‘‘pesticide product bears a claim to 

control pest microorganisms that pose a 

threat to human health and whose 

presence cannot readily be observed by 

the user including, but not limited to, 

microorganisms infectious to man in 

any area of the inanimate environment. 

* * *’’ Since this general requirement 

applies to products with prion-related 

claims, EPA is proposing to amend the 

regulation to specifically identify that 

efficacy data are required for products 

with prion-related claims. In addition, 

EPA is announcing the availability for 

public review and comment of draft test 

guidelines concerning the generation of 

product performance data for prionrelated products. 

DATES: Comments must be received on 

or before January 17, 2012. 

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. 


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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 Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through 

regulations.gov, your email address will 

be automatically captured and included 

as part of the comment that is placed in 

the docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

at http://www.regulations.gov. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either in the 

electronic docket at http:// 

www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

hours of operation of this Docket 

Facility are from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: Jeff 

Kempter, Antimicrobials Division 

(7510P), 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; email 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). 

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 email. 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 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 (TSE). 

TSE’s include scrapie disease in sheep, 


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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. Regulatory History of Products With 

Prion-Related Claims 

On September 10, 2003, EPA 

determined that a prion should be 

considered to be a ‘‘pest’’ under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) (7 U.S.C. 136 

et seq.) and that products intended to 

inactivate prions (i.e., ‘‘prion products’’) 

should be regulated under FIFRA 

(Ref. 1). 

On January 26, 2011 (76 FR 4602) 

(FRL–8850–4), to eliminate any 

confusion about the status of prionrelated products under FIFRA, EPA 

issued a proposed rule that, when 

finalized, would declare a prion a 

‘‘pest’’ under FIFRA, and amend EPA’s 

regulations to expressly include prion 

within the regulatory definition of pest. 

EPA currently considers a prion to be a 

pest under FIFRA; in addition, 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. Subject to some 

exceptions, any pesticide product must 

be registered or exempted under FIFRA 

sections 3, 24(c), or 18 before the 

product may be distributed or sold in 

the United States. 

C. Data Requirements for Pesticides 

First promulgated in 1984, EPA’s 

pesticide data requirements outline the 

kinds of data and related information 

typically needed to register a pesticide. 

Since there is much variety in pesticide 

chemistry, exposure, and hazard, the 

requirements are designed to be flexible. 

Test notes to the data requirements 

tables explain the conditions under 

which data are typically needed. 

Essentially, the data requirements 

identify the questions that the applicant 

will need to answer regarding a 

pesticide product before the Agency can 

register it. 

At this time, the data requirements for 

conventional, biochemical, and 

microbial pesticides are codified in 40 

CFR part 158, and data requirements for 

antimicrobial pesticides are codified in 

40 CFR part 161. In addition, part 158 

contains general provisions concerning 

data for the pesticides covered by the 

regulation (subpart A), instructions on 

how to use the data tables in the 

regulation (subpart B), and a series of 

data tables that identify data 

requirements tailored to specific kinds 

of pesticides, i.e., conventional 

pesticides (subparts D–O), biochemical 

pesticides (subpart U), microbial 

pesticides (subpart V), and several 

reserved subparts as placeholders for 

future tailoring of the data requirements 

that is underway to facilitate the utility 

of the data tables for pesticide 

registrants. 

On October 26, 2007, EPA revised the 

structure of part 158 and the data 

requirements for conventional 

pesticides (72 FR 60934) (FRL–8106–5), 

and biochemical pesticides and 

microbial pesticides (72 FR 60988) 

(FRL–8109–8). In conjunction with 

those revisions, EPA also transferred 

intact the original 1984 pesticide data 

requirements that had been in part 158 

into a new part 161, entitled ‘‘Data 

Requirements for Antimicrobial 

Pesticides’’ (72 FR 60251, October 24, 

2007) (FRL–8116–2). In essence, part 

161 is intended to be transitional by 

preserving the existing data 

requirements applicable to 

antimicrobial pesticides until a new 

final regulation that tailors the data 

requirements for antimicrobial 

pesticides is promulgated. On October 

8, 2008 (73 FR 59382), EPA proposed to 

establish data requirements specific to 

antimicrobial pesticide chemicals in 40 

CFR part 158, subpart W and to remove 

part 161. 

D. Test Guidelines Used To Develop 

Data for Submission to EPA 

EPA’s Office of Chemical Safety and 

Pollution Prevention (OCSPP) has 

issued a series of harmonized test 

guidelines for use in the testing of 

pesticides and toxic substances, and the 

development of test data for submission 

to the Agency. The OCSPP harmonized 

test guidelines are documents that 

specify methods that EPA recommends 

be used to generate data that are 

submitted to EPA to support the 

registration of a pesticide under FIFRA 

(7 U.S.C. 136 et seq.), setting of a 

tolerance or tolerance exemption for 

pesticide residues under section 408 of 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA) (21 U.S.C. 346a), or the 

decision making process for an 

industrial chemical under the Toxic 

Substances Control Act (TSCA) (15 

U.S.C. 2601 et seq.). 

The OCSPP harmonized test 

guidelines are developed by EPA 

scientists and non-EPA individuals with 

a particular interest or expertise in the 

subject matter covered, including 

representatives from the scientific 

community, industry, non-profit 

organizations, and other governments. 

Some of these guidelines harmonize 

EPA’s test methods with guidelines 

established by the Organization for 

Economic Cooperation and 

Development (OECD), an international 

organization whose membership 

includes most industrialized nations 

which maintain comprehensive testing 

methods for pesticides and industrial 

chemicals. When necessary, significant 

scientific issues are presented for 

external peer review to the FIFRA 

Scientific Advisory Panel (SAP) or to 

another group of scientific experts for 

that particular topic. 

The OCSPP harmonized test 

guidelines serve as a compendium of 

accepted scientific methodologies and 

protocols for conducting the studies 

routinely used for generating data on 

pesticides and industrial chemicals 

regulated under FIFRA, FFDCA, and 

TSCA, and may also be useful for 

voluntary testing purposes. 

Under FIFRA and FFDCA, studies 

conducted according to the OCSPP test 

guidelines or another approved protocol 

may be used in satisfying FIFRA data 

requirements in 40 CFR part 158 and 40 

CFR part 161, Data-Call-In’s issued 

pursuant to FIFRA section 3(c)(2)(B), as 

needed to satisfy data requirements 

appropriate for specific pesticide 

registration applications, or for 

satisfying data requirements to 

demonstrate the safety of a tolerance or 

tolerance exemption under FFDCA 

section 408. 

As a guidance document, the test 

guidelines are not binding on either 

EPA or any outside parties. At places in 

the guidance, the Agency uses the word 

‘‘should.’’ In the guidance, use of 

‘‘should’’ with regard to an action 

means that the action is recommended 

rather than mandatory. The procedures 

contained in the test guidelines are 

recommended for generating the data 

that are the subject of the test guideline, 

but EPA recognizes that departures may 

be appropriate in specific situations. 

EPA will consider alternatives to the 

recommendations described in the test 

guidelines on a case-by-case basis, after 

assessing whether the alternative will 

provide the data necessary to inform the 

regulatory decision that must be made. 

The OCSPP harmonized test 

guidelines can be accessed online at 

http://epa.gov/ocspp/pubs/frs/home/ 

testmeth.htm. Please note that although 


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collectively referred to as the ‘‘OCSPP 

Test Guidelines,’’ the individual 

guidelines issued before April 22, 2010, 

use ‘‘OPPTS’’ in the titles. On April 22, 

2010, the office name changed from 

‘‘Office of Prevention, Pesticides, and 

Toxic Substances’’ or ‘‘OPPTS’’ to 

‘‘Office of Chemical Safety and 

Pollution Prevention’’ and ‘‘OCSPP.’’ 

III. Proposed Data Requirement 

A. 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). In 

particular, the proposed rule is issued 

pursuant to FIFRA section 25(a) (7 

U.S.C. 136w(a)). 

B. What action is the agency taking? 

EPA is proposing to amend its 

pesticide data requirement regulations 

to clarify that efficacy data are required 

to support the registration of all end-use 

products that are intended to be used on 

inanimate items and/or environmental 

surfaces, and which bear label claims to 

reduce the infectivity of prions. 

Specifically, EPA proposes to amend the 

data requirements for product 

performance testing that are currently 

found in 40 CFR 158.400 and 40 CFR 

161.640 by inserting an entry in the data 

tables to more clearly specify that 

efficacy data are required for prionrelated products. 

Currently, EPA’s regulations at 40 

CFR 158.400(e)(1) and 161.640(b)(1) 

require efficacy data to be submitted 

when the ‘‘pesticide product bears a 

claim to control pest microorganisms 

that pose a threat to human health and 

whose presence cannot readily be 

observed by the user including, but not 

limited to, microorganisms infectious to 

man in any area of the inanimate 

environment. * * *’’ Because a prionrelated product would bear a claim to 

reduce the infectivity of prions (that 

poses a threat to human health), an 

applicant or registrant would be 

required by existing regulations to 

submit valid data that demonstrate that 

its prion-related product is effective. As 

such, this amendment simply provides 

more specificity for those who are 

considering whether to register a 

product for use on inanimate items and/ 

or environmental surfaces and make 

claims that the product will reduce the 

infectivity of prions. 

As indicated in Unit II.C., EPA issued 

a proposed rule in 2008 (73 FR 59382, 

October 8, 2008) that proposed to codify 

the data requirements for antimicrobial 

pesticide chemicals in 40 CFR part 158, 

subpart W. That 2008 proposed rule also 

proposed the following: 

• To remove the existing data 

requirements for antimicrobial pesticide 

chemicals that currently appear in 40 

CFR part 161 (see 73 FR at 59446). 

• To amend the table in 40 CFR 

158.400(d) by removing the category 

‘‘Efficacy of antimicrobial agents’’ and 

all of the entries under that category (see 

73 FR at 59431). 

• To create a new provision and table 

to address product performance data for 

antimicrobial agents in 40 CFR 158.2220 

(see 73 FR at 59432). 

EPA is therefore also presenting an 

alternate proposal to amend the table 

that proposed to consolidate the product 

performance data requirements for 

antimicrobials in proposed 40 CFR 

158.2220 to include an entry in the 

proposed data table at 40 CFR 

158.2220(c) to specify that efficacy data 

are required for prion-related products. 

In summary, EPA is proposing to 

more clearly specify that efficacy data 

are required for prion-related products 

by either: 

• Inserting a new entry in the data 

tables that are currently found in 40 

CFR 158.400 and 40 CFR 161.640. 

• If the 2008 proposal concerning 

proposed 40 CFR 158.2220 has been 

finalized, by inserting a new entry in the 

data table that was proposed to be 

included in 40 CFR 158.2220. 

IV. Draft Test Guidelines 

EPA is also announcing the 

availability of draft test guidelines for 

public review and comment that the 

Agency intends to include in the OCSPP 

harmonized test guidelines described in 

Unit II.D., as part of the 810 Series of 

Product Performance Test Guidelines. 

Specifically, the draft guidelines 

address product performance tests for 

products with prion-related claims and 

are identified as ‘‘Product Performance 

Test Guidelines; OCSPP 810.2700: 

Products with Prion-Related Claims’’ 

(Ref. 2). The guidelines for products 

with prion-related claims are designed 

to provide the data and information 

needed to assess the efficacy of 

antimicrobial pesticides intended to be 

used on inanimate items and/or 

environmental surfaces, and which bear 

label claims to reduce the infectivity of 

prions. 

On March 31 and April 1, 2009, EPA 

presented its draft test guidelines to the 

FIFRA SAP for peer review (Ref. 3), 

along with a ‘‘white paper’’ 

summarizing the most relevant 

scientific studies and publications 

related to the issue of whether a prion 

is a pest in support of the separate 

proposed rule on that issue. The SAP 

provided comments on the draft 

guidance document on June 29, 2009 

(Ref. 4). EPA has considered the SAP’s 

recommendations and incorporated 

changes, as appropriate (Ref. 5). In 

addition, the draft test guidelines 

underwent interagency review in 2010. 

With this document, EPA is providing 

an opportunity for public review and 

comment on the revised draft test 

guidelines. 

V. FIFRA Review Requirements 

In accordance with FIFRA sections 

25(a), 25(d), and 21(b), the Agency 

submitted a draft of this proposed rule 

to the Committee on Agriculture in the 

House of Representatives, the 

Committee on Agriculture, Nutrition, 

and Forestry in the United States 

Senate, the Secretary of Agriculture, the 

FIFRA Scientific Advisory Panel (SAP), 

and the Secretary of Health and Human 

Services. The SAP and the Secretaries of 

Agriculture and Health and Human 

Services waived review of this proposed 

rule. 

VI. Statutory and Executive Order 

Reviews 

This action only proposes to amend 

an existing regulation to include more 

specificity regarding an existing efficacy 

data requirement for products intending 

to make prion-related claims. It does not 

otherwise propose to amend or impose 

any other requirements. The proposed 

rule will not otherwise involve any 

significant policy or legal issues, and 

will not impact existing costs. As such, 

the Office of Management and Budget 

(OMB) has determined that this is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866, entitled 

Regulatory Planning and Review (58 FR 

51735, October 4, 1993) and this action 

is therefore not subject to review under 

Executive Orders 12866 and 13563, 

entitled Improving Regulation and 

Regulatory Review (76 FR 3821, January 

21, 2011). 

Nor does it impose or change any 

information collection burden that 

requires additional review by OMB 

under the provisions of the Paperwork 

Reduction Act (44 U.S.C. 3501 et seq.). 

The information collection activities 

contained in the regulation are already 

approved under information collection 

instruments related to: (1) The 

submission of data to EPA in to 

establish a tolerance or an exemption 

from the requirement to have a tolerance 

currently approved under 2070–0024 

(EPA ICR No. 0276); (2) the activities 

associated with the application for a 

new or amended registration of a 

pesticide currently approved under 

OMB Control No. 2070–0060 (EPA ICR 


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No. 0277); (3) the activities associated 

with the application for an experimental 

use permit currently approved under 

OMB Control No. 2070–0040 (EPA ICR 

No. 0276); and (4) activities associated 

with the generation of data in response 

to a Data-Call-In currently approved 

under OMB Control No. 2070–0174 

(EPA ICR No. 2288). An agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

The OMB control numbers for certain 

EPA regulations in 40 CFR are listed in 

40 CFR part 9 and in the Federal 

Register, as appropriate. 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that this proposed rule does not 

have a significant adverse economic 

impact on a substantial number of small 

entities. The proposed amendment does 

not change existing impacts. In general, 

EPA strives to minimize potential 

adverse impacts on small entities when 

developing regulations to achieve the 

environmental and human health 

protection goals of the statute and the 

Agency. EPA solicits comments 

specifically about potential small 

business impacts. 

State, local, and tribal governments 

are rarely pesticide applicants or 

registrants, so this proposed rule is not 

expected to affect these governments. 

Accordingly, pursuant to Title II of the 

Unfunded Mandates Reform Act 

(UMRA) (2 U.S.C. 1531–1538), EPA has 

determined that this action is not 

subject to the requirements in sections 

202 and 205 because it does not contain 

a Federal mandate that may result in 

expenditures of $100 million or more 

for State, local, and tribal governments, 

in the aggregate, or for the private sector 

in any 1 year. In addition, this action 

does not significantly or uniquely affect 

small governments or impose a 

significant intergovernmental mandate, 

as described in sections 203 and 204 of 

UMRA. For the same reasons, EPA has 

determined that this proposed rule does 

not have ‘‘federalism implications’’ as 

specified in Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999), because it would 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. Thus, Executive Order 13132 

does not apply to this proposed rule. 

Nor does it have ‘‘tribal implications’’ as 

specified in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

22951, November 9, 2000). EPA is not 

aware of any tribal governments which 

are pesticide registrants. Thus, 

Executive Order 13175 does not apply 

to this action. 

Since this action is not economically 

significant under Executive Order 

12866, it is not subject to Executive 

Order 13045, entitled Protection of 

Children from Environmental Health 

Risks and Safety Risks (62 FR 19885, 

April 23, 1997), and Executive Order 

13211, entitled Actions Concerning 

Regulations that Significantly Affect 

Energy Supply, Distribution, or Use (66 

FR 28355, May 22, 2001). 

This action does not involve technical 

standards that would require the 

consideration of voluntary consensus 

standards pursuant to section 12(d) of 

the National Technology Transfer and 

Advancement Act (NTTAA) (15 U.S.C. 

272 note). 

This action does not have an adverse 

impact on the environmental and health 

conditions in low-income and minority 

communities. Therefore, this action 

does not involve special consideration 

of environmental justice related issues 

as specified in Executive Order 12898, 

entitled Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

VII. 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, 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. 

2010. Product Performance Test 

Guidelines, Series 810, Draft OCSPP No. 

810.2700, entitled ‘‘Products with Prion 

Related Claims.’’ Draft dated November 

12, 2010. 

3. U.S. Environmental Protection Agency. 

2009. Product Performance Test 

Guidelines, Series 810, Draft OCSPP No. 

810.2400, entitled ‘‘Products with Prion 

Related Claims.’’ Draft dated February 

23, 2009. 

4. 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, Ph.D., Director, Office of 

Pesticide Programs. June 29, 2009. See 

http://www.epa.gov/scipoly/sap/ 

meetings/2009/march/ 

033109panelmembers.html. 

5. 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. 

List of Subjects in 40 CFR Parts 158 and 

161 

Environmental protection, 

Administrative practice and procedures, 

Agricultural commodities, Chemical 

testing, Pesticides and pests, Reporting 

and recordkeeping requirements, Test 

guidelines. 

Dated: October 31, 2011. 

Lisa P. Jackson, 

Administrator. 

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows: 

PART 158—[AMENDED] 

1. The authority citation for part 158 

continues to read as follows: 

Authority: 7 U.S.C. 136–136y, 21 U.S.C. 

346a. 

2. In § 158.400(d), amend the table 

under the category ‘‘Efficacy of 

antimicrobial agents’’ by adding a new 

entry at the end of the category to read 

as follows: 

§ 158.400 Product performance data 

requirements table. 

* * * * * 

(d) * * * 


pmangrum on DSK3VPTVN1PROD with PROPOSALS-1
Federal Register / Vol. 76, No. 222 / Thursday, November 17, 2011 / Proposed Rules 71299 

TABLE—PRODUCT PERFORMANCE DATA REQUIREMENTS

Guideline 

No. 

Data 

requirement 

Use pattern Test substance to 

support 

Test note 

No. 

Terrestrial Aquatic Greenhouse 

Forestry Residential 

outdoor Indoor Food MP EP 

crop 

Non-food 

crop Food Non-food 

Food 

crop 

Non-food 

crop 

Efficacy of antimicrobial agents 

* * * * * * * 

810.2700 Products 

with 

prionrelated 

claims.

NR NR NR NR NR NR NR NR R NR EP ................

* * * * * * * 

* * * * * 

3. As proposed at 73 FR 59432, 

October 8, 2008, § 158.2220(c) is further 

amended by adding a new entry at the 

end of the table to read as follows: 

§ 158.2220 Product performance. 

* * * * * 

(c) * * * 

TABLE—ANTIMICROBIAL PRODUCT PERFORMANCE DATA REQUIREMENTS

Guideline No. Data requirement All use patterns Test substance 

*******

810.2700 ............................................ Products with prion-related claims .................................. R ................................ EP. 

PART 161—[AMENDED] 

4. The authority citation for part 161 

is revised to read as follows: 

Authority: 7 U.S.C. 136–136y, 21 U.S.C. 

346a 

5. In § 161.640(a), amend the table 

under the category ‘‘Efficacy of 

antimicrobial agents’’ by adding a new 

entry at the end of the category to read 

as follows: 

§ 161.640 Product performance data 

requirements table. 

(a) * * * 

Kind of 

data 

required 

(b) Notes 

General use patterns Test substance 

Guideline 

reference 

No. 

Terrestrial Aquatic Greenhouse 

Forestry Domestic 

outdoor Indoor 

Data to 

support 

MP 

Data to 

support 

EP Food 

crop 

Non-food 

crop Food Non-food 

Food 

crop 

Non-food 

crop 

Efficacy of anti-microbial agent 

* * * * * * * 

Products 

with 

prion-related 

claims.

................ .......... ................ .......... ................ .......... ................ ................ ................ R ............ ................ EP * ........ 810.2700 

*******

* * * * * 

[FR Doc. 2011–29463 Filed 11–16–11; 8:45 am] 

BILLING CODE 6560–50–P 


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