Source: https://www.govinfo.gov/content/pkg/FR-2013-02-28/html/2013-04613.htm
Timestamp: 2019-02-17 18:31:11
Document Index: 562237421

Matched Legal Cases: ['arts 158', 'art 158', 'art\n161', 'art 158', 'art 158', 'art 158', 'art 161', 'art 161', 'art 158', 'art 161', 'art 9', 'ART 152', 'ART 158', 'ART 161', 'art 161']

[Pages 13501-13507]
[FR Doc No: 2013-04613]
[EPA-HQ-OPP-2010-0427; FRL-9372-7]
Declaration of Prion as a Pest Under FIFRA; Related Amendments;
and Availability of Final Test Guidelines
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.
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.
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,
(703) 308-2716; fax number: (703) 308-6467; email address:
morrow.melba@epa.gov.
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:
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)).
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
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.
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.
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.
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
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
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
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.
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.
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.
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
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.
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.
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
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
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
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
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.
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
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
otherwise involve any significant policy or legal issues, but does
impact existing costs.
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
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.
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.
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).
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.
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
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.
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.
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
uniquely affect small governments. These amendments are unlikely to
affect State, local, and tribal governments at
all, and are likely to affect the private sector only trivially.
This rule does not have federalism implications because it will not
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.
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
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997),
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.
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not a significant regulatory action under
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.
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
Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
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
the rule must submit a report, which includes a copy of the rule, to
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
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
``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
``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
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.
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
Environmental protection, Administrative practice and procedures,
Agricultural commodities, Chemical testing, Pesticides and pests,
Reporting and recordkeeping requirements, Test guidelines.
PART 152--[AMENDED]
Authority:  7 U.S.C. 136-136y; subpart U is also issued under 31
U.S.C. 9701.
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
section 201(i)).
PART 158--[AMENDED]
Authority:  7 U.S.C. 136-136y, 21 U.S.C. 346a.
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
810.2700.......  Products with       NR................  NR................  NR................  NR................  NR................  NR................  NR................  NR................  R.................  NR...............  EP...............  1
prion-related
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 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
Sec.  161.640  Product performance data requirements table.
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
Products with prion-related     *................  .................  .................  .................  .................  .................  .................  .................  R...............  ................  EP *............  810.2700........