Document ID: EPA-HQ-OPP-2010-0427-0029
Agency: epa
Document Type: Rule
Title: Declaration of Prion as Pest under Federal Insecticide, Fungicide, and Rodenticide Act: Related Amendments; Availability of Final Test Guidelines
Posted Date: 2013-02-28T05:00Z

[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Rules and Regulations]
[Pages 13501-13507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04613]

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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.

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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 prion-related pesticide products.

DATES: This final rule is effective April 29, 2013.

[[Page 13502]]

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 prion-related 
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 
prion-related 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 PrP\c\ (cellular isoform) while abnormal conformations of 
prion proteins are generally called prions. Different types of prions 
are commonly designated by the type of diseases they produce, such as 
PrP\Sc\ (prions associated with scrapie) and PrP\BSE\ (prions 
associated with bovine spongiform encephalopathy--mad cow disease).
    In the disease process, prions (such as PrP\sc\) recruit normal 
prion proteins (PrP\c\) and convert them into prions (e.g., another 
copy of PrP\Sc\). This recruitment and conversion process results in 
the progressive accumulation of disease-producing prions. When this 
process takes place in the brain, it causes disease that slowly 
progresses from neuronal dysfunction and degeneration to death. These 
neurodegenerative prion diseases are known collectively as 
transmissible spongiform encephalopathies (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.

[[Page 13503]]

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

[[Page 13504]]

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 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 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 
prion-related 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 prion-related 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 prion-related claims. It 
does not otherwise amend or impose any other requirements. This rule 
does not

[[Page 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 
prion-related 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 prion-related 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 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.

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

[[Page 13506]]

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 Prion-
Related 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.

[[Page 13507]]

June 29, 2009. See http://www.epa.gov/scipoly/sap/meetings/2009/march/033109panelmembers.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]

0
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.

0
2. In Sec.  152.5, revise paragraph (d) to read as follows:

Sec.  152.5  Pests.

* * * * *
    (d) Any fungus, bacterium, virus, prion, or other microorganism, 
except for those on or in living man or other living animals and those 
on or in processed food or processed animal feed, beverages, drugs (as 
defined in FFDCA section 201(g)(1)) and cosmetics (as defined in FFDCA 
section 201(i)).

PART 158--[AMENDED]

0
3. The authority citation for part 158 continues to read as follows:

    Authority:  7 U.S.C. 136-136y, 21 U.S.C. 346a.

0
4. In Sec.  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:

Sec.  158.400  Product performance data requirements table.

* * * * *

                                                                                                                  Table--Product Performance Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                         Use pattern                                                                                           Test substance to support
                                    --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   Guideline      Data requirement                 Terrestrial                               Aquatic                               Greenhouse                                                                                                                    Test note No.
     number                         ------------------------------------------------------------------------------------------------------------------------      Forestry           Residential           Indoor                MP                 EP
                                          Food crop         Non-food crop           Food              Non-food            Food crop         Non-food crop                              outdoor
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Efficacy of antimicrobial agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                                                                                  * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
810.2700.......  Products with       NR................  NR................  NR................  NR................  NR................  NR................  NR................  NR................  R.................  NR...............  EP...............  1
                  prion-related
                  claims.
 
                                                                                                                                  * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

PART 161--[AMENDED]

0
5. The authority citation for part 161 continues to read as follows:

    Authority: 7 U.S.C. 136-136y, 21 U.S.C. 346a.

0
6. In Sec.  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:

Sec.  161.640  Product performance data requirements table.

    (a) * * *

 
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                             General use patterns                                                                                     Test substance
                                                  -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Kind of data  required          (b) Notes                   Terrestrial                             Aquatic                             Greenhouse                                                                                                              Guideline
                                                  ------------------------------------------------------------------------------------------------------------------      Forestry      Domestic outdoor       Indoor        Data to support   Data to support    reference No.
                                                       Food crop        Non-food crop           Food             Non-food          Food crop        Non-food crop                                                                  MP                EP
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Efficacy of antimicrobial agents
 
                                                                                                                                  * * * * * * *
Products with prion-related     *................  .................  .................  .................  .................  .................  .................  .................  R...............  ................  EP *............  810.2700........
 claims.
 
                                                                                                                                  * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-04613 Filed 2-27-13; 8:45 am]
BILLING CODE 6560-50-P