Federal Register / Vol. 78, No. 40 / Thursday, February 28, 2013 / Rules and Regulations 13501 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian 

country, and EPA notes that it will not 

impose substantial direct costs on tribal 

governments or preempt tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by April 29, 2013. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this action for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. Parties with 

objections to this direct final rule are 

encouraged to file any comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the proposed rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged later in proceedings to 

enforce its requirements. See section 

307(b)(2). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Dated: February 12, 2013. 

A. Stanley Meiburg, 

Acting Regional Administrator, Region 4. 

40 CFR part 52 is amended as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart RR—Tennessee 

■ 2. Section 52.2220(c) is amended by 

revising entries in Table 3 for ‘‘Sections 

25.0 and 46.0’’ to read as follows: 

§ 52.2220 Identification of plan. 

* * * * * 

(c) * * * 

TABLE 3—EPA APPROVED KNOX COUNTY, REGULATIONS

State section Title/Subject State effective 

date EPA Approval date Explanation 

*******

Section 25.0 ............................... Permits ....................................... 10/10/2012 2/28/13 [Insert first page of publication].

*******

Section 46.0 ............................... Regulation of Volatile Organic 

Compounds.

8/12/2009 2/28/13 [Insert first page of publication].

*******

* * * * * 

[FR Doc. 2013–04412 Filed 2–27–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 152, 158 and 161 

[EPA–HQ–OPP–2010–0427; FRL–9372–7] 

RIN 2070–AJ26 

Declaration of Prion as a Pest Under 

FIFRA; Related Amendments; and 

Availability of Final Test Guidelines 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: With this final rule EPA 

declares a prion (i.e., proteinaceous 

infectious particle) to be a ‘‘pest’’ under 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) and amends 

the regulations to expressly include 

prion within the regulatory definition of 

pest. This final rule also amends 

existing pesticide product performance 

data requirements to clarify that efficacy 

data are required for pesticide products 

with prion-related claims. In addition, 

EPA is announcing the availability of 

final test guidelines on generating the 

product performance data for prionrelated pesticide products. 

DATES: This final rule is effective April 

29, 2013. 


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ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0427, is 

available at http://www.regulations.gov 

or at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in the 

EPA West Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. In 

addition to being available in the 

docket, a copy of the final test 

guidelines titled ‘‘Product Performance 

Test Guidelines, OCSPP 810.2700: 

Products with Prion-Related Claims’’ is 

available online at http://epa.gov/ocspp/ 

pubs/frs/home/testmeth.htm. 

FOR FURTHER INFORMATION CONTACT: 

Melba Morrow, Antimicrobials Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–2716; fax number: (703) 308– 

6467; email address: 

morrow.melba@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you apply for or own 

pesticide registrations. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document might 

apply to them. 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). 

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). In 

particular, the final rule is issued 

pursuant to FIFRA section 25(a) (7 

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

C. What action is the agency taking? 

EPA declares a prion (i.e., 

proteinaceous infectious particle) to be 

a ‘‘pest’’ under FIFRA, and amends its 

regulations to expressly include prion 

within the regulatory definition of pest. 

Since 2003, EPA has considered 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, subject to some possible 

exceptions, 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 rule codifies the 

Agency’s current interpretation of 

FIFRA with respect to prions. The 

amendment of the definition of ‘‘pest’’ 

in EPA’s regulations, together with the 

formal declaration under FIFRA section 

25(c)(1) that a prion is a pest, eliminates 

any confusion about the status of prionrelated products under FIFRA. 

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. 

EPA is also amending 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 product 

performance data requirement applies to 

products with prion-related claims, EPA 

is amending the regulation to 

specifically identify the efficacy data 

that are required for products with 

prion-related claims. In addition, EPA is 

announcing the availability of final test 

guidelines concerning the generation of 

product performance data for prionrelated products. 

D. What are the incremental costs and 

benefits of this action? 

This final rule will: (a) Codify the 

Agency’s current interpretation of 

FIFRA by adding ‘‘prion’’ to the list of 

pests in 40 CFR 152.5, and (b) amend 

the pesticide data requirement 

regulations to clarify that efficacy data 

are required to support the registration 

of all end-use products which bear label 

claims to reduce the infectivity of 

prions. The qualitative benefits of this 

final rule relate to the protection of 

human health and the environment by 

subjecting prion-related products to 

regulation under FIFRA, including all 

data and labeling requirements. The 

incremental costs of this rule are 

estimated to range from $424,000 to 

$4.72 million per pesticide registration 

action. See also Unit VI.A. 

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). 

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 among sheep, CWD among 

cervids) or to humans (e.g., BSE), and 

that human-related prions may be 

passed to other humans (e.g., kuru or 

vCJD). These diseases are always fatal in 

humans and animals alike, and there are 

no known treatments or cures. 


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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 

FIFRA (7 U.S.C. 136 et seq.) and that 

products intended to inactivate prions 

(i.e., ‘‘prion-related products’’) should 

be regulated under FIFRA (Ref. 1). 

In the Federal Register issue of 

January 26, 2011 (76 FR 4602) (FRL– 

8850–4), to eliminate any confusion 

about the status of prion-related 

products under FIFRA, EPA issued a 

proposed rule that, when finalized, 

would declare a prion a ‘‘pest’’ under 

FIFRA pursuant to the authority of 

FIFRA section 25(c)(1), 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. 

In the Federal Register issue of 

November 17, 2011 (76 FR 71294) (FRL– 

8886–1), as a supplement to the 

proposed rule to declare a prion (i.e., 

proteinaceous infectious particle) a 

‘‘pest’’ under FIFRA, and to amend its 

regulations to expressly include prion 

with the regulatory definition of pest 

(January 26, 2011; 76 FR 4602), EPA 

proposed to amend its product 

performance data requirements in 40 

CFR parts 158 and 161 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 product 

performance data requirement applies to 

products with prion-related claims, EPA 

proposed to amend the regulation to 

specifically identify the efficacy data 

required for products with prion-related 

claims. In addition, EPA announced the 

availability for public review and 

comment of draft test guidelines 

concerning the generation of product 

performance data for prion-related 

products. 

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 and other information in the 

regulation 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 

consider it for registration. 

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, such as reserved subpart W 

for antimicrobials. 

On October 26, 2007, EPA revised the 

structure of part 158 and the data 

requirements for conventional 

pesticides (72 FR 60934), and 

biochemical pesticides and microbial 

pesticides (72 FR 60988). 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, 

titled ‘‘Data Requirements for 

Antimicrobial Pesticides’’ (72 FR 60251, 

October 24, 2007). 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 

40 CFR part 161. To date, these 

proposed changes have not been 

promulgated. 

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 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 regulatory activities for other 

chemical substances under the Toxic 

Substances Control Act (TSCA) (15 

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

harmonized test guidelines serve as a 

compendium of EPA-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. The OCSPP harmonized test 

guidelines can be accessed online at 

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

testmeth.htm. 

III. Public Comments on the Proposed 

Rules 

All of the comments submitted to EPA 

on both of the proposed rules are 

included in the docket for this 

rulemaking under docket ID number 

EPA–HQ–OPP–2010–0427. EPA 

prepared two Response to Comment 

documents that summarize the 

comments received and provide EPA’s 

detailed responses to all comments 

received. This unit discusses, in general 

terms, the public comments and EPA’s 

responses to those comments. 

A. Public Comments on the January 

2011 Proposal 

In response to the January 2011 

proposed rule, six parties submitted 

comments—one in favor, four against, 

and one neutral. The commenter in 

favor of the proposed rule expressed 

concern about the threat posed to 

human health from prions and the need 

to use an existing regulatory scheme to 

assure protection of public health. The 

commenters disagreed with the 

proposed rule and cited a range of 

reasons: Poor statutory analysis, use of 

regulatory authority to modify the intent 

of Congress and to bypass the 

lawmaking processes, declaring prions 

to be pests even though they are not 


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13504 Federal Register / Vol. 78, No. 40 / Thursday, February 28, 2013 / Rules and Regulations 

alive, and declaring a prion to be a pest 

could lead to further declarations that 

other non-living materials are pests. 

EPA’s responses to these comments may 

be found in the document titled ‘‘EPA, 

Office of Pesticide Programs (OPP), 

Responses to Comments Received 

Concerning ‘Declaration of Prion as a 

Pest Under FIFRA and Amendment of 

EPA’s Regulatory Definition of Pests to 

Include Prion.’ ’’ (Ref. 2). Overall, EPA 

was not persuaded by the negative 

comments to not issue the final rule as 

proposed. 

B. Public Comments on the November 

2011 Supplemental Proposed Rule 

In response to the November 2011 

supplemental proposed rule (76 FR 

71294), two parties submitted 

comments—one in favor and one against 

the proposed supplemental rule. The 

first commenter advocated that EPA 

regulate all possible prion carriers that 

have any likelihood of being transmitted 

to human beings, since the commenter 

stated that she lost her mother to 

sporadic Creutzfeldt Jakob Disease. The 

second commenter expressed 

opposition to the proposed 

supplemental rule, submitting the exact 

same comments that he had submitted 

previously for the proposed rule. EPA’s 

responses to these comments may be 

found in the document titled ‘‘EPA, 

Office of Pesticide Programs (OPP), 

Responses to Comments Received 

Concerning ‘Prions: Proposed 

Amendment to Clarify Product 

Performance Data for Products With 

Prion-Related Claims and Availability of 

Draft Test Guidelines’ ’’ (Ref. 3). Overall, 

EPA was not persuaded by the negative 

comment to not issue the changes to 

EPA’s existing regulations as proposed. 

IV. The Final Rule 

EPA is finalizing the proposed 

changes as proposed. Specifically, EPA 

has determined that under FIFRA a 

prion is considered to be a pest; thus, 

pursuant to the authority of FIFRA 

section 25(c)(1), EPA is declaring a 

prion to be a pest. For the same reasons, 

EPA is amending the regulatory 

definition of ‘‘pests’’ in 40 CFR 152.5 to 

expressly include ‘‘prion.’’ These 

actions make explicit the Agency’s 

authority to regulate products 

distributed or sold for the purpose of 

reducing the infectivity of prions (i.e., 

prion-related products), other than 

prions on or in living humans 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)). 

Prion-related products are already 

regulated under FIFRA and subject to all 

requirements and provisions of the Act 

based on EPA’s September 10, 2003 

decision (Ref. 1) 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 rule ensures 

that the regulatory definition reflects the 

Agency’s authority to regulate prionrelated 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 under 

FIFRA sections 3 or 24(c), or otherwise 

exempted before such products may be 

distributed or sold in the United States. 

EPA is also amending 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 is amending 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 prion-related products. 

Currently, EPA’s regulations at 40 

CFR 158.400(e)(1) and 40 CFR 

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 prion-related 

product bears a claim to reduce the 

infectivity of prions (that poses a threat 

to human health), an applicant or 

registrant is required by existing 

regulations to submit valid data that 

demonstrate that its prion-related 

product is effective. As such, today’s 

amendment to the data requirements 

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. In 

summary, EPA is clearly specifying that 

efficacy data are required for prionrelated products by inserting a new 

entry in the data tables that are 

currently found in 40 CFR 158.400 and 

40 CFR 161.640. 

EPA is also announcing the 

availability of final test guidelines that 

the Agency now includes in the OCSPP 

harmonized test guidelines described in 

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

of Product Performance Test Guidelines. 

Specifically, the final 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. 4). The 

guidelines for products with prionrelated claims provide guidance 

concerning 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. 5), 

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 (Ref. 6). The 

SAP provided comments on the draft 

guidance document on June 29, 2009 

(Ref. 7). EPA has considered the SAP’s 

recommendations and incorporated 

changes, as appropriate (Ref. 8). In 

addition, the draft test guidelines 

underwent interagency review in 2010. 

V. FIFRA Mandated Reviews 

In accordance with FIFRA section 

25(a) and (d), on August 2, 2012, EPA 

submitted a draft of this final rule to the 

Secretary of the Senate, the Clerk of the 

House of Representatives, the 

Committee on Agriculture in the House 

of Representatives, the Committee on 

Agriculture, Nutrition, and Forestry in 

the United States Senate, the United 

States Department of Agriculture 

(USDA), and the FIFRA Scientific 

Advisory Panel (SAP). In accordance 

with FIFRA section 21(b), EPA also 

submitted a draft of this final rule to the 

Secretary of Health and Human Services 

(HHS). The HHS and SAP waived 

review of this final rule. USDA 

submitted comments on September 5, 

2012, to which EPA responded on 

December 3, 2012 (see docket noted in 

ADDRESSES above). 

VI. Statutory and Executive Order 

Reviews 

This action amends existing 

regulations to include prion as a pest 

and to add more specificity regarding an 

existing efficacy data requirement for 

products intending to make prionrelated claims. It does not otherwise 

amend or impose any other 

requirements. This rule does not 


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Federal Register / Vol. 78, No. 40 / Thursday, February 28, 2013 / Rules and Regulations 13505 

otherwise involve any significant policy 

or legal issues, but does impact existing 

costs. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This action is not a ‘‘significant 

regulatory action’’ under the terms of 

Executive Order 12866 (58 FR 51735, 

October 4, 1993) and was not therefore 

submitted to the Office of Management 

and Budget (OMB) for review under 

Executive Orders 12866 and 13563 (76 

FR 3821, January 21, 2011). 

EPA prepared an economic analysis of 

the potential costs associated with this 

action, titled ‘‘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).’’ The Economic Analysis (EA) 

presents the Agency’s assessment of the 

potential costs and benefits expected to 

result from this rule. In terms of 

benefits, the 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 this rule per 

registration action range from $424,000 

to $4.72 million (Ref. 9). 

The EA presents the costs of various 

types of registrations under this rule and 

presents expected incremental costs for 

three product registration types. The 

three types of registration actions which 

are possible under this rule are the 

registration of: (1) A new active 

ingredient, (2) a new use product, or (3) 

amendment of an existing registration to 

add a new use. 

The EA estimates that three firms 

might seek registrations for major new 

use products in the first year. If all uses 

are high exposure (e.g., indirect food 

uses) for a new active ingredient, 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 

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 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 

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 prionrelated products that were expressed by 

product users to EPA during its 

outreach efforts to these users. 

B. Paperwork Reduction Act (PRA) 

This action does not impose any new 

significant information collection 

burden that would require additional 

review or approval by OMB under the 

PRA, 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 to 

establish a tolerance or an exemption 

from the requirement to have a tolerance 

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 currently 

approved under OMB Control No. 2070– 

0060 (EPA ICR 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). 

4. Activities associated with the 

generation of data in response to a DataCall-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. 

C. Regulatory Flexibility Act (RFA) 

The RFA, 5 U.S.C. 601 et seq., 

generally requires an agency to prepare 

a regulatory flexibility analysis of any 

rule subject to notice and comment 

rulemaking requirements under the 

Administrative Procedure Act, 5 U.S.C. 

551–553, or any other statute unless the 

agency certifies that the rule will not 

have a significant economic impact on 

a substantial number of small entities. 

Small entities include small 

businesses, small organizations, and 

small governmental jurisdictions. For 

purposes of assessing the impacts of this 

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. A small 

business that manufactures pesticides 

and other agricultural chemicals as 

defined by NAICS code 325320 has 500 

or fewer employees based on the SBA 

standards. 

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; or 

3. A small organization that is any 

not-for-profit enterprise which is 

independently owned and operated and 

is not dominant in its field. 

After considering the economic 

impacts of this final rule on small 

entities, I certify that this action will not 

have a significant economic impact on 

a substantial number of small entities. 

The amendments do not change existing 

impacts. Although no small entities 

have been identified that are directly 

affected by these amendments, any such 

impacts are likely to be minimal. 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. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Title II of UMRA, 2 U.S.C. 1531–1538, 

establishes requirements for Federal 

agencies to assess the effects of their 

regulatory actions on State, local, and 

tribal governments and the private 

sector. This rule 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 the private sector in 

any 1 year. Thus, this rule is not subject 

to the requirements of UMRA sections 

202 or 205. This rule is also not subject 

to the requirements of UMRA section 

203, because it contains no regulatory 

requirements that might significantly or 

uniquely affect small governments. 

These amendments are unlikely to affect 

State, local, and tribal governments at 


srobinson on DSK4SPTVN1PROD with RULES
13506 Federal Register / Vol. 78, No. 40 / Thursday, February 28, 2013 / Rules and Regulations 

all, and are likely to affect the private 

sector only trivially. 

E. Executive Order 13132: Federalism 

This 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 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). State and local 

governments are rarely pesticide 

applicants or registrants, so these 

amendments are not expected to affect 

these governments. Thus, Executive 

Order 13132 does not apply to this 

action. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000). This action will not have 

substantial direct effects on Indian 

Tribes, will not significantly or uniquely 

affect the communities of Indian Tribal 

governments, and does not involve or 

impose any requirements that affect 

Indian Tribes. Tribal governments are 

rarely pesticide applicants or 

registrants, so these amendments are not 

expected to affect these governments. 

Thus, Executive Order 13175 does not 

apply to this action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

EPA interprets Executive Order 13045 

(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 the Executive 

Order 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, nor is it an ‘‘economically 

significant regulatory action’’ as defined 

in Executive Order 12866. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211 (66 FR 28355, May 22, 

2001), because it is not a significant 

regulatory action under Executive Order 

12866. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

Section 12(d) of 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 

otherwise impractical. Voluntary 

consensus standards are technical 

standards (e.g., materials specifications, 

test methods, sampling procedures, and 

business practices) 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 involve any technical 

standards. Therefore, EPA did not 

consider the use of any voluntary 

consensus standards. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

Executive Order 12898 (59 FR 7629, 

February 16, 1994) establishes Federal 

executive policy on environmental 

justice. Its main provision directs 

Federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA has determined that this final 

rule will not have disproportionately 

high and adverse human health or 

environmental effects on minority or 

low-income populations, because it 

generally increases the level of 

protection provided to human health or 

the environment and thereby not 

adversely affect any population. This 

rule does not entail special 

considerations of environmental justice 

related issues. 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a report, which includes a copy 

of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

VIII. References 

The following is a listing of the 

documents that are specifically 

referenced in this document. The docket 

(under docket ID number EPA–HQ– 

OPP–2010–0427) 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 contact 

person 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. 

2012. EPA, Office of Pesticide Programs 

(OPP), Responses to Comments Received 

Concerning ‘‘Declaration of Prion as a Pest 

Under FIFRA and Amendment of EPA’s 

Regulatory Definition of Pests to Include 

Prion.’’ 

3. U.S. Environmental Protection Agency. 

2012. EPA, Office of Pesticide Programs 

(OPP), Responses to Comments Received 

Concerning ‘‘Prions: Proposed Amendment 

to Clarify Product Performance Data for 

Products With Prion-Related Claims and 

Availability of Draft Test Guidelines.’’ 

4. U.S. Environmental Protection Agency. 

2012. Product Performance Test Guidelines, 

OCSPP 810.2700: ‘‘Products with PrionRelated Claims.’’ Final December 2012. 

5. U.S. Environmental Protection Agency. 

2009. Product Performance Test Guidelines, 

Series 810, Draft OCSPP No. 810.XXXX, 

titled ‘‘Products with Prion-Related Claims.’’ 

Draft dated February 23, 2009. 

6. 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 (FIFRA). Draft dated 

December 17, 2008. 

7. 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. 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 40 / Thursday, February 28, 2013 / Rules and Regulations 13507 

June 29, 2009. See http://www.epa.gov/ 

scipoly/sap/meetings/2009/march/033109

panelmembers.html. 

8. 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. 

9. U.S. Environmental Protection Agency. 

2010. 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). 

List of Subjects in 40 CFR Parts 152, 

158 and 161 

Environmental protection, 

Administrative practice and procedures, 

Agricultural commodities, Chemical 

testing, Pesticides and pests, Reporting 

and recordkeeping requirements, Test 

guidelines. 

Dated: February 21, 2013. 

Bob Perciasepe, 

Acting Administrator. 

Therefore, 40 CFR chapter I is 

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. In § 152.5, revise 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)). 

PART 158—[AMENDED] 

■ 3. The authority citation for part 158 

continues to read as follows: 

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

346a. 

■ 4. 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. 

* * * * * 

TABLE—PRODUCT PERFORMANCE DATA REQUIREMENTS

Guideline 

number Data requirement 

Use pattern Test substance to 

support 

Test 

note 

No. 

Terrestrial Aquatic Greenhouse 

Forestry 

Residential 

outdoor 

Indoor Food MP EP 

crop 

Nonfood 

crop Food Nonfood 

Food 

crop 

Nonfood 

crop 

Efficacy of antimicrobial agents 

*******

810.2700 ..... Products with prionrelated claims.NR ....... NR ....... NR ....... NR ....... NR ....... NR ....... NR ....... NR ....... R ......... NR ....... EP ....... 1 

* * * * * * * 

* * * * * 

PART 161—[AMENDED] 

■ 5. The authority citation for part 161 

continues to read as follows: 

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

346a. 

■ 6. In § 161.640, revise the section 

heading and in paragraph (a) amend the 

table by adding under the category 

‘‘Efficacy of antimicrobial agents’’ 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 

Nonfood 

crop Food Nonfood 

Food 

crop 

Nonfood 

crop 

Efficacy of antimicrobial agents 

* * * * * * * 

Products with 

prion-related 

claims.

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

*******

* * * * * 

[FR Doc. 2013–04613 Filed 2–27–13; 8:45 am] 

BILLING CODE 6560–50–P 


srobinson on DSK4SPTVN1PROD with RULES