Prions; Proposed Amendment To Clarify Product Performance Data for Products With Prion-Related Claims and Availability of Draft Test Guidelines, 71294-71299 [2011-29463]
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Dated: October 24, 2011.
Melissa Hartman,
Deputy Assistant Secretary for Privacy,
Transparency, and Records.
[FR Doc. 2011–29384 Filed 11–16–11; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 158 and 161
[EPA–HQ–OPP–2010–0427; FRL–8886–1]
RIN 2070–AJ26
Prions; Proposed Amendment To
Clarify Product Performance Data for
Products With Prion-Related Claims
and Availability of Draft Test
Guidelines
Environmental Protection
Agency (EPA).
ACTION: Supplemental proposed rule.
AGENCY:
As a supplement to the
proposed rule to declare a prion (i.e.,
proteinaceous infectious particle) a
‘‘pest’’ under the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), and to amend its regulations to
expressly include prion within the
regulatory definition of pest, EPA is
now proposing to amend its product
performance data requirements to
clarify that efficacy data are required for
all products with prion-related claims.
The existing product performance data
requirements already require efficacy
data to be submitted when the
‘‘pesticide product bears a claim to
control pest microorganisms that pose a
threat to human health and whose
presence cannot readily be observed by
the user including, but not limited to,
microorganisms infectious to man in
any area of the inanimate environment.
* * *’’ Since this general requirement
applies to products with prion-related
claims, EPA is proposing to amend the
regulation to specifically identify that
efficacy data are required for products
with prion-related claims. In addition,
EPA is announcing the availability for
public review and comment of draft test
guidelines concerning the generation of
product performance data for prionrelated products.
DATES: Comments must be received on
or before January 17, 2012.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2010–0427, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
SUMMARY:
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Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2010–
0427. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or
email. The regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email comment directly
to EPA without going through
regulations.gov, your email address will
be automatically captured and included
as part of the comment that is placed in
the docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either in the
electronic docket at https://
www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
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holidays. The Docket Facility telephone
number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT: Jeff
Kempter, Antimicrobials Division
(7510P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5448; fax number: (703) 308–
6467; email address:
kempter.carlton@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you apply for or own
pesticide registrations. Potentially
affected entities may include, but are
not limited to:
• Producers of pesticide products
(NAICS code 32532).
• Producers of antimicrobial
pesticides (NAICS code 32561).
• Veterinary testing laboratories
(NAICS code 541940).
• Medical pathology laboratories
(NAICS code 621511).
• Taxidermists, independent (NAICS
code 711510).
• Surgeons (NAICS code 621111).
• Dental surgeons (NAICS code
621210).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
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will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
II. Background
A. What is a Prion?
Prions (‘‘proteinaceous infectious
particles’’) may occur in the central
nervous system tissues of animals as an
abnormal (‘‘misfolded’’), infectious form
of prion protein. Prion protein in its
normal form, or conformation, can be
designated PrPc (‘‘cellular’’ isoform)
while abnormal conformations of prion
proteins are generally called prions.
Different types of prions are commonly
designated by the type of diseases they
produce, such as PrPSc (prions
associated with scrapie) and PrPBSE
(prions associated with bovine
spongiform encephalopathy—mad cow
disease).
In the disease process, prions (such as
PrPsc) recruit normal prion proteins
(PrPc) and convert them into prions
(e.g., another copy of PrPSc). This
recruitment and conversion process
results in the progressive accumulation
of disease-producing prions. When this
process takes place in the brain, it
causes disease that slowly progresses
from neuronal dysfunction and
degeneration to death. These
neurodegenerative prion diseases are
known collectively as transmissible
spongiform encephalopathies (TSE).
TSE’s include scrapie disease in sheep,
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bovine spongiform encephalopathy
(BSE) in cattle, chronic wasting disease
(CWD) in deer and elk, kuru and variant
Creutzfeld-Jakob Disease (vCJD) in
humans, and similar diseases in other
animals. EPA and other agencies are
concerned that animal-related prions
may spread to other animals (e.g.,
scrapie to sheep, CWD to cervids) or to
humans (e.g., BSE), and that humanrelated prions may be passed to other
humans (e.g., kuru or CJD). These
diseases are always fatal in humans and
animals alike, and there are no known
treatments or cures.
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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
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136
et seq.) and that products intended to
inactivate prions (i.e., ‘‘prion products’’)
should be regulated under FIFRA
(Ref. 1).
On January 26, 2011 (76 FR 4602)
(FRL–8850–4), to eliminate any
confusion about the status of prionrelated products under FIFRA, EPA
issued a proposed rule that, when
finalized, would declare a prion a
‘‘pest’’ under FIFRA, and amend EPA’s
regulations to expressly include prion
within the regulatory definition of pest.
EPA currently considers a prion to be a
pest under FIFRA; in addition, a
product intended to reduce the
infectivity of any prion on inanimate
surfaces (i.e., a ‘‘prion-related product’’)
is considered to be a pesticide and
regulated as such. Subject to some
exceptions, any pesticide product must
be registered or exempted under FIFRA
sections 3, 24(c), or 18 before the
product may be distributed or sold in
the United States.
C. Data Requirements for Pesticides
First promulgated in 1984, EPA’s
pesticide data requirements outline the
kinds of data and related information
typically needed to register a pesticide.
Since there is much variety in pesticide
chemistry, exposure, and hazard, the
requirements are designed to be flexible.
Test notes to the data requirements
tables explain the conditions under
which data are typically needed.
Essentially, the data requirements
identify the questions that the applicant
will need to answer regarding a
pesticide product before the Agency can
register it.
At this time, the data requirements for
conventional, biochemical, and
microbial pesticides are codified in 40
CFR part 158, and data requirements for
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antimicrobial pesticides are codified in
40 CFR part 161. In addition, part 158
contains general provisions concerning
data for the pesticides covered by the
regulation (subpart A), instructions on
how to use the data tables in the
regulation (subpart B), and a series of
data tables that identify data
requirements tailored to specific kinds
of pesticides, i.e., conventional
pesticides (subparts D–O), biochemical
pesticides (subpart U), microbial
pesticides (subpart V), and several
reserved subparts as placeholders for
future tailoring of the data requirements
that is underway to facilitate the utility
of the data tables for pesticide
registrants.
On October 26, 2007, EPA revised the
structure of part 158 and the data
requirements for conventional
pesticides (72 FR 60934) (FRL–8106–5),
and biochemical pesticides and
microbial pesticides (72 FR 60988)
(FRL–8109–8). In conjunction with
those revisions, EPA also transferred
intact the original 1984 pesticide data
requirements that had been in part 158
into a new part 161, entitled ‘‘Data
Requirements for Antimicrobial
Pesticides’’ (72 FR 60251, October 24,
2007) (FRL–8116–2). In essence, part
161 is intended to be transitional by
preserving the existing data
requirements applicable to
antimicrobial pesticides until a new
final regulation that tailors the data
requirements for antimicrobial
pesticides is promulgated. On October
8, 2008 (73 FR 59382), EPA proposed to
establish data requirements specific to
antimicrobial pesticide chemicals in 40
CFR part 158, subpart W and to remove
part 161.
D. Test Guidelines Used To Develop
Data for Submission to EPA
EPA’s Office of Chemical Safety and
Pollution Prevention (OCSPP) has
issued a series of harmonized test
guidelines for use in the testing of
pesticides and toxic substances, and the
development of test data for submission
to the Agency. The OCSPP harmonized
test guidelines are documents that
specify methods that EPA recommends
be used to generate data that are
submitted to EPA to support the
registration of a pesticide under FIFRA
(7 U.S.C. 136 et seq.), setting of a
tolerance or tolerance exemption for
pesticide residues under section 408 of
the Federal Food, Drug, and Cosmetic
Act (FFDCA) (21 U.S.C. 346a), or the
decision making process for an
industrial chemical under the Toxic
Substances Control Act (TSCA) (15
U.S.C. 2601 et seq.).
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The OCSPP harmonized test
guidelines are developed by EPA
scientists and non-EPA individuals with
a particular interest or expertise in the
subject matter covered, including
representatives from the scientific
community, industry, non-profit
organizations, and other governments.
Some of these guidelines harmonize
EPA’s test methods with guidelines
established by the Organization for
Economic Cooperation and
Development (OECD), an international
organization whose membership
includes most industrialized nations
which maintain comprehensive testing
methods for pesticides and industrial
chemicals. When necessary, significant
scientific issues are presented for
external peer review to the FIFRA
Scientific Advisory Panel (SAP) or to
another group of scientific experts for
that particular topic.
The OCSPP harmonized test
guidelines serve as a compendium of
accepted scientific methodologies and
protocols for conducting the studies
routinely used for generating data on
pesticides and industrial chemicals
regulated under FIFRA, FFDCA, and
TSCA, and may also be useful for
voluntary testing purposes.
Under FIFRA and FFDCA, studies
conducted according to the OCSPP test
guidelines or another approved protocol
may be used in satisfying FIFRA data
requirements in 40 CFR part 158 and 40
CFR part 161, Data-Call-In’s issued
pursuant to FIFRA section 3(c)(2)(B), as
needed to satisfy data requirements
appropriate for specific pesticide
registration applications, or for
satisfying data requirements to
demonstrate the safety of a tolerance or
tolerance exemption under FFDCA
section 408.
As a guidance document, the test
guidelines are not binding on either
EPA or any outside parties. At places in
the guidance, the Agency uses the word
‘‘should.’’ In the guidance, use of
‘‘should’’ with regard to an action
means that the action is recommended
rather than mandatory. The procedures
contained in the test guidelines are
recommended for generating the data
that are the subject of the test guideline,
but EPA recognizes that departures may
be appropriate in specific situations.
EPA will consider alternatives to the
recommendations described in the test
guidelines on a case-by-case basis, after
assessing whether the alternative will
provide the data necessary to inform the
regulatory decision that must be made.
The OCSPP harmonized test
guidelines can be accessed online at
https://epa.gov/ocspp/pubs/frs/home/
testmeth.htm. Please note that although
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collectively referred to as the ‘‘OCSPP
Test Guidelines,’’ the individual
guidelines issued before April 22, 2010,
use ‘‘OPPTS’’ in the titles. On April 22,
2010, the office name changed from
‘‘Office of Prevention, Pesticides, and
Toxic Substances’’ or ‘‘OPPTS’’ to
‘‘Office of Chemical Safety and
Pollution Prevention’’ and ‘‘OCSPP.’’
III. Proposed Data Requirement
A. What is the agency’s authority for
taking this action?
This action is issued under the
authority of sections 2 through 34 of
FIFRA (7 U.S.C. 136–136y). In
particular, the proposed rule is issued
pursuant to FIFRA section 25(a) (7
U.S.C. 136w(a)).
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B. What action is the agency taking?
EPA is proposing to amend its
pesticide data requirement regulations
to clarify that efficacy data are required
to support the registration of all end-use
products that are intended to be used on
inanimate items and/or environmental
surfaces, and which bear label claims to
reduce the infectivity of prions.
Specifically, EPA proposes to amend the
data requirements for product
performance testing that are currently
found in 40 CFR 158.400 and 40 CFR
161.640 by inserting an entry in the data
tables to more clearly specify that
efficacy data are required for prionrelated products.
Currently, EPA’s regulations at 40
CFR 158.400(e)(1) and 161.640(b)(1)
require efficacy data to be submitted
when the ‘‘pesticide product bears a
claim to control pest microorganisms
that pose a threat to human health and
whose presence cannot readily be
observed by the user including, but not
limited to, microorganisms infectious to
man in any area of the inanimate
environment. * * *’’ Because a prionrelated product would bear a claim to
reduce the infectivity of prions (that
poses a threat to human health), an
applicant or registrant would be
required by existing regulations to
submit valid data that demonstrate that
its prion-related product is effective. As
such, this amendment simply provides
more specificity for those who are
considering whether to register a
product for use on inanimate items and/
or environmental surfaces and make
claims that the product will reduce the
infectivity of prions.
As indicated in Unit II.C., EPA issued
a proposed rule in 2008 (73 FR 59382,
October 8, 2008) that proposed to codify
the data requirements for antimicrobial
pesticide chemicals in 40 CFR part 158,
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subpart W. That 2008 proposed rule also
proposed the following:
• To remove the existing data
requirements for antimicrobial pesticide
chemicals that currently appear in 40
CFR part 161 (see 73 FR at 59446).
• To amend the table in 40 CFR
158.400(d) by removing the category
‘‘Efficacy of antimicrobial agents’’ and
all of the entries under that category (see
73 FR at 59431).
• To create a new provision and table
to address product performance data for
antimicrobial agents in 40 CFR 158.2220
(see 73 FR at 59432).
EPA is therefore also presenting an
alternate proposal to amend the table
that proposed to consolidate the product
performance data requirements for
antimicrobials in proposed 40 CFR
158.2220 to include an entry in the
proposed data table at 40 CFR
158.2220(c) to specify that efficacy data
are required for prion-related products.
In summary, EPA is proposing to
more clearly specify that efficacy data
are required for prion-related products
by either:
• Inserting a new entry in the data
tables that are currently found in 40
CFR 158.400 and 40 CFR 161.640.
• If the 2008 proposal concerning
proposed 40 CFR 158.2220 has been
finalized, by inserting a new entry in the
data table that was proposed to be
included in 40 CFR 158.2220.
IV. Draft Test Guidelines
EPA is also announcing the
availability of draft test guidelines for
public review and comment that the
Agency intends to include in the OCSPP
harmonized test guidelines described in
Unit II.D., as part of the 810 Series of
Product Performance Test Guidelines.
Specifically, the draft guidelines
address product performance tests for
products with prion-related claims and
are identified as ‘‘Product Performance
Test Guidelines; OCSPP 810.2700:
Products with Prion-Related Claims’’
(Ref. 2). The guidelines for products
with prion-related claims are designed
to provide the data and information
needed to assess the efficacy of
antimicrobial pesticides intended to be
used on inanimate items and/or
environmental surfaces, and which bear
label claims to reduce the infectivity of
prions.
On March 31 and April 1, 2009, EPA
presented its draft test guidelines to the
FIFRA SAP for peer review (Ref. 3),
along with a ‘‘white paper’’
summarizing the most relevant
scientific studies and publications
related to the issue of whether a prion
is a pest in support of the separate
proposed rule on that issue. The SAP
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provided comments on the draft
guidance document on June 29, 2009
(Ref. 4). EPA has considered the SAP’s
recommendations and incorporated
changes, as appropriate (Ref. 5). In
addition, the draft test guidelines
underwent interagency review in 2010.
With this document, EPA is providing
an opportunity for public review and
comment on the revised draft test
guidelines.
V. FIFRA Review Requirements
In accordance with FIFRA sections
25(a), 25(d), and 21(b), the Agency
submitted a draft of this proposed rule
to the Committee on Agriculture in the
House of Representatives, the
Committee on Agriculture, Nutrition,
and Forestry in the United States
Senate, the Secretary of Agriculture, the
FIFRA Scientific Advisory Panel (SAP),
and the Secretary of Health and Human
Services. The SAP and the Secretaries of
Agriculture and Health and Human
Services waived review of this proposed
rule.
VI. Statutory and Executive Order
Reviews
This action only proposes to amend
an existing regulation to include more
specificity regarding an existing efficacy
data requirement for products intending
to make prion-related claims. It does not
otherwise propose to amend or impose
any other requirements. The proposed
rule will not otherwise involve any
significant policy or legal issues, and
will not impact existing costs. As such,
the Office of Management and Budget
(OMB) has determined that this is not a
‘‘significant regulatory action’’ under
Executive Order 12866, entitled
Regulatory Planning and Review (58 FR
51735, October 4, 1993) and this action
is therefore not subject to review under
Executive Orders 12866 and 13563,
entitled Improving Regulation and
Regulatory Review (76 FR 3821, January
21, 2011).
Nor does it impose or change any
information collection burden that
requires additional review by OMB
under the provisions of the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.).
The information collection activities
contained in the regulation are already
approved under information collection
instruments related to: (1) The
submission of data to EPA in to
establish a tolerance or an exemption
from the requirement to have a tolerance
currently approved under 2070–0024
(EPA ICR No. 0276); (2) the activities
associated with the application for a
new or amended registration of a
pesticide currently approved under
OMB Control No. 2070–0060 (EPA ICR
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No. 0277); (3) the activities associated
with the application for an experimental
use permit currently approved under
OMB Control No. 2070–0040 (EPA ICR
No. 0276); and (4) activities associated
with the generation of data in response
to a Data-Call-In currently approved
under OMB Control No. 2070–0174
(EPA ICR No. 2288). An agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
The OMB control numbers for certain
EPA regulations in 40 CFR are listed in
40 CFR part 9 and in the Federal
Register, as appropriate.
Pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency hereby
certifies that this proposed rule does not
have a significant adverse economic
impact on a substantial number of small
entities. The proposed amendment does
not change existing impacts. In general,
EPA strives to minimize potential
adverse impacts on small entities when
developing regulations to achieve the
environmental and human health
protection goals of the statute and the
Agency. EPA solicits comments
specifically about potential small
business impacts.
State, local, and tribal governments
are rarely pesticide applicants or
registrants, so this proposed rule is not
expected to affect these governments.
Accordingly, pursuant to Title II of the
Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1531–1538), EPA has
determined that this action is not
subject to the requirements in sections
202 and 205 because it does not contain
a Federal mandate that may result in
expenditures of $100 million or more
for State, local, and tribal governments,
in the aggregate, or for the private sector
in any 1 year. In addition, this action
does not significantly or uniquely affect
small governments or impose a
significant intergovernmental mandate,
as described in sections 203 and 204 of
UMRA. For the same reasons, EPA has
determined that this proposed rule does
not have ‘‘federalism implications’’ as
specified in Executive Order 13132,
entitled Federalism (64 FR 43255,
August 10, 1999), because it would not
have substantial direct effects on the
States, on the relationship between the
national government and the States, or
on the distribution of power and
responsibilities among the various
levels of government, as specified in the
Order. Thus, Executive Order 13132
does not apply to this proposed rule.
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Nor does it have ‘‘tribal implications’’ as
specified in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
22951, November 9, 2000). EPA is not
aware of any tribal governments which
are pesticide registrants. Thus,
Executive Order 13175 does not apply
to this action.
Since this action is not economically
significant under Executive Order
12866, it is not subject to Executive
Order 13045, entitled Protection of
Children from Environmental Health
Risks and Safety Risks (62 FR 19885,
April 23, 1997), and Executive Order
13211, entitled Actions Concerning
Regulations that Significantly Affect
Energy Supply, Distribution, or Use (66
FR 28355, May 22, 2001).
This action does not involve technical
standards that would require the
consideration of voluntary consensus
standards pursuant to section 12(d) of
the National Technology Transfer and
Advancement Act (NTTAA) (15 U.S.C.
272 note).
This action does not have an adverse
impact on the environmental and health
conditions in low-income and minority
communities. Therefore, this action
does not involve special consideration
of environmental justice related issues
as specified in Executive Order 12898,
entitled Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
VII. References
As indicated under ADDRESSES, a
docket has been established for this
rulemaking under docket ID number
EPA–HQ–OPP–2010–0427. The
following is a listing of the documents
that are specifically referenced in this
document. The docket includes these
documents and other information
considered by EPA, including
documents that are referenced within
the documents that are included in the
docket, even if the referenced document
is not physically located in the docket.
For assistance in locating these other
documents, please consult the technical
contact listed under FOR FURTHER
INFORMATION CONTACT.
1. U.S. Environmental Protection Agency.
2004. Considerations of Prions as a Pest
under FIFRA. Memorandum to the
Record from Susan B. Hazen, Principal
Deputy Assistant Administrator, Office
of Prevention, Pesticides, and Toxic
Substances. April 29, 2004.
2. U.S. Environmental Protection Agency.
2010. Product Performance Test
PO 00000
Frm 00028
Fmt 4702
Sfmt 4702
Guidelines, Series 810, Draft OCSPP No.
810.2700, entitled ‘‘Products with Prion
Related Claims.’’ Draft dated November
12, 2010.
3. U.S. Environmental Protection Agency.
2009. Product Performance Test
Guidelines, Series 810, Draft OCSPP No.
810.2400, entitled ‘‘Products with Prion
Related Claims.’’ Draft dated February
23, 2009.
4. U.S. Environmental Protection Agency.
2009. Transmittal of Meeting Minutes of
the FIFRA Scientific Advisory Panel
Meeting Held March 31–April 1, 2009 on
‘‘Scientific Issues Associated with
Designating a Prion as a ‘Pest’ under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and Related
Efficacy Test Methods.’’ Memorandum
from Myrta R. Christian, Designated
Federal Official, FIFRA Scientific
Advisory Panel, Office of Science
Coordination and Policy, to Debbie
Edwards, Ph.D., Director, Office of
Pesticide Programs. June 29, 2009. See
https://www.epa.gov/scipoly/sap/
meetings/2009/march/
033109panelmembers.html.
5. U.S. Environmental Protection Agency.
2010. EPA Responses to Comments by
the FIFRA Scientific Advisory Panel
Concerning ‘‘Scientific Information
Concerning the Issue of Whether Prions
Are a ‘Pest’ under the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA).’’ February 17, 2010.
List of Subjects in 40 CFR Parts 158 and
161
Environmental protection,
Administrative practice and procedures,
Agricultural commodities, Chemical
testing, Pesticides and pests, Reporting
and recordkeeping requirements, Test
guidelines.
Dated: October 31, 2011.
Lisa P. Jackson,
Administrator.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
PART 158—[AMENDED]
1. The authority citation for part 158
continues to read as follows:
Authority: 7 U.S.C. 136–136y, 21 U.S.C.
346a.
2. In § 158.400(d), amend the table
under the category ‘‘Efficacy of
antimicrobial agents’’ by adding a new
entry at the end of the category to read
as follows:
§ 158.400 Product performance data
requirements table.
*
*
*
(d) * * *
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Federal Register / Vol. 76, No. 222 / Thursday, November 17, 2011 / Proposed Rules
TABLE—PRODUCT PERFORMANCE DATA REQUIREMENTS
Use pattern
Guideline
No.
Data
requirement
Terrestrial
Food
crop
Aquatic
Non-food
crop
Test substance to
support
Greenhouse
Food
Non-food
Food
crop
Non-food
crop
NR
*
NR
NR
*
NR
Forestry
Residential
outdoor
Test note
No.
Indoor
MP
*
R
NR
EP
Efficacy of antimicrobial agents
810.2700
*
Products
with
prionrelated
claims.
*
NR
NR
*
*
*
*
*
*
*
*
3. As proposed at 73 FR 59432,
October 8, 2008, § 158.2220(c) is further
*
NR
NR
*
*
amended by adding a new entry at the
end of the table to read as follows:
*
EP
*
§ 158.2220
*
................
*
Product performance.
*
*
(c) * * *
*
*
TABLE—ANTIMICROBIAL PRODUCT PERFORMANCE DATA REQUIREMENTS
Guideline No.
Data requirement
All use patterns
*
*
810.2700 ............................................
*
*
*
Products with prion-related claims ..................................
*
R ................................
entry at the end of the category to read
as follows:
5. In § 161.640(a), amend the table
under the category ‘‘Efficacy of
antimicrobial agents’’ by adding a new
4. The authority citation for part 161
is revised to read as follows:
§ 161.640 Product performance data
requirements table.
(a) * * *
General use patterns
Terrestrial
(b) Notes
Food
crop
*
EP.
Authority: 7 U.S.C. 136–136y, 21 U.S.C.
346a
PART 161—[AMENDED]
Kind of
data
required
Test substance
Test substance
Greenhouse
Aquatic
Non-food
crop
Food
Non-food
Food
crop
Non-food
crop
*
................
..........
*
................
..........
*
................
Data to
support
MP
Forestry
Domestic
outdoor
*
................
*
R ............
................
*
EP * ........
Indoor
................
Data to
support
EP
Guideline
reference
No.
Efficacy of anti-microbial agent
Products
with
prion-related
claims.
*
................
..........
*
*
*
*
*
*
*
*
*
*
*
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]]>Agencies
[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Proposed Rules]
[Pages 71294-71299]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29463]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 158 and 161
[EPA-HQ-OPP-2010-0427; FRL-8886-1]
RIN 2070-AJ26
Prions; Proposed Amendment To Clarify Product Performance Data
for Products With Prion-Related Claims and Availability of Draft Test
Guidelines
AGENCY: Environmental Protection Agency (EPA).
ACTION: Supplemental proposed rule.
-----------------------------------------------------------------------
SUMMARY: As a supplement to the proposed rule to declare a prion (i.e.,
proteinaceous infectious particle) a ``pest'' under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to amend its
regulations to expressly include prion within the regulatory definition
of pest, EPA is now proposing to amend its product performance data
requirements to clarify that efficacy data are required for all
products with prion-related claims. The existing product performance
data requirements already require efficacy data to be submitted when
the ``pesticide product bears a claim to control pest microorganisms
that pose a threat to human health and whose presence cannot readily be
observed by the user including, but not limited to, microorganisms
infectious to man in any area of the inanimate environment. * * *''
Since this general requirement applies to products with prion-related
claims, EPA is proposing to amend the regulation to specifically
identify that efficacy data are required for products with prion-
related claims. In addition, EPA is announcing the availability for
public review and comment of draft test guidelines concerning the
generation of product performance data for prion-related products.
DATES: Comments must be received on or before January 17, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0427, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S.
[[Page 71295]]
Crystal Dr., Arlington, VA. Deliveries are only accepted during the
Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays). Special arrangements
should be made for deliveries of boxed information. The Docket Facility
telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0427. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or
email. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-5448; fax number: (703) 308-6467; email address:
kempter.carlton@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you apply for or
own pesticide registrations. Potentially affected entities may include,
but are not limited to:
Producers of pesticide products (NAICS code 32532).
Producers of antimicrobial pesticides (NAICS code 32561).
Veterinary testing laboratories (NAICS code 541940).
Medical pathology laboratories (NAICS code 621511).
Taxidermists, independent (NAICS code 711510).
Surgeons (NAICS code 621111).
Dental surgeons (NAICS code 621210).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What is a Prion?
Prions (``proteinaceous infectious particles'') may occur in the
central nervous system tissues of animals as an abnormal
(``misfolded''), infectious form of prion protein. Prion protein in its
normal form, or conformation, can be designated 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). TSE's include scrapie
disease in sheep,
[[Page 71296]]
bovine spongiform encephalopathy (BSE) in cattle, chronic wasting
disease (CWD) in deer and elk, kuru and variant Creutzfeld-Jakob
Disease (vCJD) in humans, and similar diseases in other animals. EPA
and other agencies are concerned that animal-related prions may spread
to other animals (e.g., scrapie to sheep, CWD to cervids) or to humans
(e.g., BSE), and that human-related prions may be passed to other
humans (e.g., kuru or CJD). These diseases are always fatal in humans
and animals alike, and there are no known treatments or cures.
B. Regulatory History of Products With Prion-Related Claims
On September 10, 2003, EPA determined that a prion should be
considered to be a ``pest'' under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.) and that products
intended to inactivate prions (i.e., ``prion products'') should be
regulated under FIFRA (Ref. 1).
On January 26, 2011 (76 FR 4602) (FRL-8850-4), to eliminate any
confusion about the status of prion-related products under FIFRA, EPA
issued a proposed rule that, when finalized, would declare a prion a
``pest'' under FIFRA, and amend EPA's regulations to expressly include
prion within the regulatory definition of pest. EPA currently considers
a prion to be a pest under FIFRA; in addition, a product intended to
reduce the infectivity of any prion on inanimate surfaces (i.e., a
``prion-related product'') is considered to be a pesticide and
regulated as such. Subject to some exceptions, any pesticide product
must be registered or exempted under FIFRA sections 3, 24(c), or 18
before the product may be distributed or sold in the United States.
C. Data Requirements for Pesticides
First promulgated in 1984, EPA's pesticide data requirements
outline the kinds of data and related information typically needed to
register a pesticide. Since there is much variety in pesticide
chemistry, exposure, and hazard, the requirements are designed to be
flexible. Test notes to the data requirements tables explain the
conditions under which data are typically needed. Essentially, the data
requirements identify the questions that the applicant will need to
answer regarding a pesticide product before the Agency can register it.
At this time, the data requirements for conventional, biochemical,
and microbial pesticides are codified in 40 CFR part 158, and data
requirements for antimicrobial pesticides are codified in 40 CFR part
161. In addition, part 158 contains general provisions concerning data
for the pesticides covered by the regulation (subpart A), instructions
on how to use the data tables in the regulation (subpart B), and a
series of data tables that identify data requirements tailored to
specific kinds of pesticides, i.e., conventional pesticides (subparts
D-O), biochemical pesticides (subpart U), microbial pesticides (subpart
V), and several reserved subparts as placeholders for future tailoring
of the data requirements that is underway to facilitate the utility of
the data tables for pesticide registrants.
On October 26, 2007, EPA revised the structure of part 158 and the
data requirements for conventional pesticides (72 FR 60934) (FRL-8106-
5), and biochemical pesticides and microbial pesticides (72 FR 60988)
(FRL-8109-8). In conjunction with those revisions, EPA also transferred
intact the original 1984 pesticide data requirements that had been in
part 158 into a new part 161, entitled ``Data Requirements for
Antimicrobial Pesticides'' (72 FR 60251, October 24, 2007) (FRL-8116-
2). In essence, part 161 is intended to be transitional by preserving
the existing data requirements applicable to antimicrobial pesticides
until a new final regulation that tailors the data requirements for
antimicrobial pesticides is promulgated. On October 8, 2008 (73 FR
59382), EPA proposed to establish data requirements specific to
antimicrobial pesticide chemicals in 40 CFR part 158, subpart W and to
remove part 161.
D. Test Guidelines Used To Develop Data for Submission to EPA
EPA's Office of Chemical Safety and Pollution Prevention (OCSPP)
has issued a series of harmonized test guidelines for use in the
testing of pesticides and toxic substances, and the development of test
data for submission to the Agency. The OCSPP harmonized test guidelines
are documents that specify methods that EPA recommends be used to
generate data that are submitted to EPA to support the registration of
a pesticide under FIFRA (7 U.S.C. 136 et seq.), setting of a tolerance
or tolerance exemption for pesticide residues under section 408 of the
Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a), or the
decision making process for an industrial chemical under the Toxic
Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.).
The OCSPP harmonized test guidelines are developed by EPA
scientists and non-EPA individuals with a particular interest or
expertise in the subject matter covered, including representatives from
the scientific community, industry, non-profit organizations, and other
governments. Some of these guidelines harmonize EPA's test methods with
guidelines established by the Organization for Economic Cooperation and
Development (OECD), an international organization whose membership
includes most industrialized nations which maintain comprehensive
testing methods for pesticides and industrial chemicals. When
necessary, significant scientific issues are presented for external
peer review to the FIFRA Scientific Advisory Panel (SAP) or to another
group of scientific experts for that particular topic.
The OCSPP harmonized test guidelines serve as a compendium of
accepted scientific methodologies and protocols for conducting the
studies routinely used for generating data on pesticides and industrial
chemicals regulated under FIFRA, FFDCA, and TSCA, and may also be
useful for voluntary testing purposes.
Under FIFRA and FFDCA, studies conducted according to the OCSPP
test guidelines or another approved protocol may be used in satisfying
FIFRA data requirements in 40 CFR part 158 and 40 CFR part 161, Data-
Call-In's issued pursuant to FIFRA section 3(c)(2)(B), as needed to
satisfy data requirements appropriate for specific pesticide
registration applications, or for satisfying data requirements to
demonstrate the safety of a tolerance or tolerance exemption under
FFDCA section 408.
As a guidance document, the test guidelines are not binding on
either EPA or any outside parties. At places in the guidance, the
Agency uses the word ``should.'' In the guidance, use of ``should''
with regard to an action means that the action is recommended rather
than mandatory. The procedures contained in the test guidelines are
recommended for generating the data that are the subject of the test
guideline, but EPA recognizes that departures may be appropriate in
specific situations. EPA will consider alternatives to the
recommendations described in the test guidelines on a case-by-case
basis, after assessing whether the alternative will provide the data
necessary to inform the regulatory decision that must be made.
The OCSPP harmonized test guidelines can be accessed online at
https://epa.gov/ocspp/pubs/frs/home/testmeth.htm. Please note that
although
[[Page 71297]]
collectively referred to as the ``OCSPP Test Guidelines,'' the
individual guidelines issued before April 22, 2010, use ``OPPTS'' in
the titles. On April 22, 2010, the office name changed from ``Office of
Prevention, Pesticides, and Toxic Substances'' or ``OPPTS'' to ``Office
of Chemical Safety and Pollution Prevention'' and ``OCSPP.''
III. Proposed Data Requirement
A. What is the agency's authority for taking this action?
This action is issued under the authority of sections 2 through 34
of FIFRA (7 U.S.C. 136-136y). In particular, the proposed rule is
issued pursuant to FIFRA section 25(a) (7 U.S.C. 136w(a)).
B. What action is the agency taking?
EPA is proposing to amend its pesticide data requirement
regulations to clarify that efficacy data are required to support the
registration of all end-use products that are intended to be used on
inanimate items and/or environmental surfaces, and which bear label
claims to reduce the infectivity of prions. Specifically, EPA proposes
to amend the data requirements for product performance testing that are
currently found in 40 CFR 158.400 and 40 CFR 161.640 by inserting an
entry in the data tables to more clearly specify that efficacy data are
required for prion-related products.
Currently, EPA's regulations at 40 CFR 158.400(e)(1) and
161.640(b)(1) require efficacy data to be submitted when the
``pesticide product bears a claim to control pest microorganisms that
pose a threat to human health and whose presence cannot readily be
observed by the user including, but not limited to, microorganisms
infectious to man in any area of the inanimate environment. * * *''
Because a prion-related product would bear a claim to reduce the
infectivity of prions (that poses a threat to human health), an
applicant or registrant would be required by existing regulations to
submit valid data that demonstrate that its prion-related product is
effective. As such, this amendment simply provides more specificity for
those who are considering whether to register a product for use on
inanimate items and/or environmental surfaces and make claims that the
product will reduce the infectivity of prions.
As indicated in Unit II.C., EPA issued a proposed rule in 2008 (73
FR 59382, October 8, 2008) that proposed to codify the data
requirements for antimicrobial pesticide chemicals in 40 CFR part 158,
subpart W. That 2008 proposed rule also proposed the following:
To remove the existing data requirements for antimicrobial
pesticide chemicals that currently appear in 40 CFR part 161 (see 73 FR
at 59446).
To amend the table in 40 CFR 158.400(d) by removing the
category ``Efficacy of antimicrobial agents'' and all of the entries
under that category (see 73 FR at 59431).
To create a new provision and table to address product
performance data for antimicrobial agents in 40 CFR 158.2220 (see 73 FR
at 59432).
EPA is therefore also presenting an alternate proposal to amend the
table that proposed to consolidate the product performance data
requirements for antimicrobials in proposed 40 CFR 158.2220 to include
an entry in the proposed data table at 40 CFR 158.2220(c) to specify
that efficacy data are required for prion-related products.
In summary, EPA is proposing to more clearly specify that efficacy
data are required for prion-related products by either:
Inserting a new entry in the data tables that are
currently found in 40 CFR 158.400 and 40 CFR 161.640.
If the 2008 proposal concerning proposed 40 CFR 158.2220
has been finalized, by inserting a new entry in the data table that was
proposed to be included in 40 CFR 158.2220.
IV. Draft Test Guidelines
EPA is also announcing the availability of draft test guidelines
for public review and comment that the Agency intends to include in the
OCSPP harmonized test guidelines described in Unit II.D., as part of
the 810 Series of Product Performance Test Guidelines. Specifically,
the draft guidelines address product performance tests for products
with prion-related claims and are identified as ``Product Performance
Test Guidelines; OCSPP 810.2700: Products with Prion-Related Claims''
(Ref. 2). The guidelines for products with prion-related claims are
designed to provide the data and information needed to assess the
efficacy of antimicrobial pesticides intended to be used on inanimate
items and/or environmental surfaces, and which bear label claims to
reduce the infectivity of prions.
On March 31 and April 1, 2009, EPA presented its draft test
guidelines to the FIFRA SAP for peer review (Ref. 3), along with a
``white paper'' summarizing the most relevant scientific studies and
publications related to the issue of whether a prion is a pest in
support of the separate proposed rule on that issue. The SAP provided
comments on the draft guidance document on June 29, 2009 (Ref. 4). EPA
has considered the SAP's recommendations and incorporated changes, as
appropriate (Ref. 5). In addition, the draft test guidelines underwent
interagency review in 2010.
With this document, EPA is providing an opportunity for public
review and comment on the revised draft test guidelines.
V. FIFRA Review Requirements
In accordance with FIFRA sections 25(a), 25(d), and 21(b), the
Agency submitted a draft of this proposed rule to the Committee on
Agriculture in the House of Representatives, the Committee on
Agriculture, Nutrition, and Forestry in the United States Senate, the
Secretary of Agriculture, the FIFRA Scientific Advisory Panel (SAP),
and the Secretary of Health and Human Services. The SAP and the
Secretaries of Agriculture and Health and Human Services waived review
of this proposed rule.
VI. Statutory and Executive Order Reviews
This action only proposes to amend an existing regulation to
include more specificity regarding an existing efficacy data
requirement for products intending to make prion-related claims. It
does not otherwise propose to amend or impose any other requirements.
The proposed rule will not otherwise involve any significant policy or
legal issues, and will not impact existing costs. As such, the Office
of Management and Budget (OMB) has determined that this is not a
``significant regulatory action'' under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993) and this
action is therefore not subject to review under Executive Orders 12866
and 13563, entitled Improving Regulation and Regulatory Review (76 FR
3821, January 21, 2011).
Nor does it impose or change any information collection burden that
requires additional review by OMB under the provisions of the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.). The information collection
activities contained in the regulation are already approved under
information collection instruments related to: (1) The submission of
data to EPA in to establish a tolerance or an exemption from the
requirement to have a tolerance currently approved under 2070-0024 (EPA
ICR No. 0276); (2) the activities associated with the application for a
new or amended registration of a pesticide currently approved under OMB
Control No. 2070-0060 (EPA ICR
[[Page 71298]]
No. 0277); (3) the activities associated with the application for an
experimental use permit currently approved under OMB Control No. 2070-
0040 (EPA ICR No. 0276); and (4) activities associated with the
generation of data in response to a Data-Call-In currently approved
under OMB Control No. 2070-0174 (EPA ICR No. 2288). An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number. The OMB control numbers for certain EPA regulations in
40 CFR are listed in 40 CFR part 9 and in the Federal Register, as
appropriate.
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this proposed
rule does not have a significant adverse economic impact on a
substantial number of small entities. The proposed amendment does not
change existing impacts. In general, EPA strives to minimize potential
adverse impacts on small entities when developing regulations to
achieve the environmental and human health protection goals of the
statute and the Agency. EPA solicits comments specifically about
potential small business impacts.
State, local, and tribal governments are rarely pesticide
applicants or registrants, so this proposed rule is not expected to
affect these governments. Accordingly, pursuant to Title II of the
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-1538), EPA has
determined that this action is not subject to the requirements in
sections 202 and 205 because it does not contain a Federal mandate that
may result in expenditures of $100 million or more for State, local,
and tribal governments, in the aggregate, or for the private sector in
any 1 year. In addition, this action does not significantly or uniquely
affect small governments or impose a significant intergovernmental
mandate, as described in sections 203 and 204 of UMRA. For the same
reasons, EPA has determined that this proposed rule does not have
``federalism implications'' as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999), because it would
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in the Order. Thus, Executive Order 13132 does not apply
to this proposed rule. Nor does it have ``tribal implications'' as
specified in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 22951, November 9,
2000). EPA is not aware of any tribal governments which are pesticide
registrants. Thus, Executive Order 13175 does not apply to this action.
Since this action is not economically significant under Executive
Order 12866, it is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), and Executive Order 13211, entitled
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001).
This action does not involve technical standards that would require
the consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act (NTTAA)
(15 U.S.C. 272 note).
This action does not have an adverse impact on the environmental
and health conditions in low-income and minority communities.
Therefore, this action does not involve special consideration of
environmental justice related issues as specified in Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994).
VII. References
As indicated under ADDRESSES, a docket has been established for
this rulemaking under docket ID number EPA-HQ-OPP-2010-0427. The
following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical contact listed under FOR FURTHER INFORMATION CONTACT.
1. U.S. Environmental Protection Agency. 2004. Considerations of
Prions as a Pest under FIFRA. Memorandum to the Record from Susan B.
Hazen, Principal Deputy Assistant Administrator, Office of
Prevention, Pesticides, and Toxic Substances. April 29, 2004.
2. U.S. Environmental Protection Agency. 2010. Product Performance
Test Guidelines, Series 810, Draft OCSPP No. 810.2700, entitled
``Products with Prion Related Claims.'' Draft dated November 12,
2010.
3. U.S. Environmental Protection Agency. 2009. Product Performance
Test Guidelines, Series 810, Draft OCSPP No. 810.2400, entitled
``Products with Prion Related Claims.'' Draft dated February 23,
2009.
4. U.S. Environmental Protection Agency. 2009. Transmittal of
Meeting Minutes of the FIFRA Scientific Advisory Panel Meeting Held
March 31-April 1, 2009 on ``Scientific Issues Associated with
Designating a Prion as a `Pest' under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test
Methods.'' Memorandum from Myrta R. Christian, Designated Federal
Official, FIFRA Scientific Advisory Panel, Office of Science
Coordination and Policy, to Debbie Edwards, Ph.D., Director, Office
of Pesticide Programs. June 29, 2009. See https://www.epa.gov/scipoly/sap/meetings/2009/march/033109panelmembers.html.
5. U.S. Environmental Protection Agency. 2010. EPA Responses to
Comments by the FIFRA Scientific Advisory Panel Concerning
``Scientific Information Concerning the Issue of Whether Prions Are
a `Pest' under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA).'' February 17, 2010.
List of Subjects in 40 CFR Parts 158 and 161
Environmental protection, Administrative practice and procedures,
Agricultural commodities, Chemical testing, Pesticides and pests,
Reporting and recordkeeping requirements, Test guidelines.
Dated: October 31, 2011.
Lisa P. Jackson,
Administrator.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 158--[AMENDED]
1. The authority citation for part 158 continues to read as
follows:
Authority: 7 U.S.C. 136-136y, 21 U.S.C. 346a.
2. In 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.
* * * * *
(d) * * *
[[Page 71299]]
Table--Product Performance Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Use pattern Test substance to
----------------------------------------------------------------------------------------------------------- support
Terrestrial Aquatic Greenhouse ------------------------ Test note
Guideline No. Data requirement ------------------------------------------------------------------ Residential No.
Food Non-food Food Non-food Forestry outdoor Indoor MP EP
crop crop Food Non-food crop crop
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of antimicrobial agents
* * * * * * *
810.2700...................... Products with NR NR NR NR NR NR NR NR R NR EP ..........
prion-related
claims.
* * * * * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
3. As proposed at 73 FR 59432, October 8, 2008, Sec. 158.2220(c)
is further amended by adding a new entry at the end of the table to
read as follows:
Sec. 158.2220 Product performance.
* * * * *
(c) * * *
Table--Antimicrobial Product Performance Data Requirements
----------------------------------------------------------------------------------------------------------------
Guideline No. Data requirement All use patterns Test substance
----------------------------------------------------------------------------------------------------------------
* * * * * * *
810.2700....................... Products with R............................ EP.
prion-related
claims.
----------------------------------------------------------------------------------------------------------------
PART 161--[AMENDED]
4. The authority citation for part 161 is revised to read as
follows:
Authority: 7 U.S.C. 136-136y, 21 U.S.C. 346a
5. In Sec. 161.640(a), amend the table under the category
``Efficacy of antimicrobial agents'' by adding a new entry at the end
of the category to read as follows:
Sec. 161.640 Product performance data requirements table.
(a) * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------
Terrestrial Aquatic Greenhouse Guideline
Kind of data required (b) Notes ------------------------------------------------------------------- Domestic Data to Data to reference No.
Food Non-food Food Non-food Forestry outdoor Indoor support MP support EP
crop crop Food Non-food crop crop
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of anti-microbial agent
* * * * * * *
Products with prion-related ............ ........ ........... ....... ........... ....... ........... ........... ........... R.......... ........... EP *....... 810.2700
claims.
* * * * * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. 2011-29463 Filed 11-16-11; 8:45 am]
BILLING CODE 6560-50-P
