Document ID: EPA-HQ-OPP-2010-0427-0020
Agency: epa
Document Type: Proposed Rule
Title: Clarification of Product Performance Data for Products with Prion-Related Claims; Availability
Posted Date: 2011-11-17T05:00Z

[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: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S.

[[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 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or 
email. The regulations.gov Web site is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an email 
comment directly to EPA without going through regulations.gov, your 
email address will be automatically captured and included as part of 
the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials Division 
(7510P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5448; fax number: (703) 308-6467; email address: 
kempter.carlton@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you apply for or 
own pesticide registrations. Potentially affected entities may include, 
but are not limited to:
     Producers of pesticide products (NAICS code 32532).
     Producers of antimicrobial pesticides (NAICS code 32561).
     Veterinary testing laboratories (NAICS code 541940).
     Medical pathology laboratories (NAICS code 621511).
     Taxidermists, independent (NAICS code 711510).
     Surgeons (NAICS code 621111).
     Dental surgeons (NAICS code 621210).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What is a Prion?

    Prions (``proteinaceous infectious particles'') may occur in the 
central nervous system tissues of animals as an abnormal 
(``misfolded''), infectious form of prion protein. Prion protein in its 
normal form, or conformation, can be designated 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 
http://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 http://www.epa.gov/scipoly/sap/meetings/2009/march/033109panelmembers.html.
5. U.S. Environmental Protection Agency. 2010. EPA Responses to 
Comments by the FIFRA Scientific Advisory Panel Concerning 
``Scientific Information Concerning the Issue of Whether Prions Are 
a `Pest' under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA).'' February 17, 2010.

List of Subjects in 40 CFR Parts 158 and 161

    Environmental protection, Administrative practice and procedures, 
Agricultural commodities, Chemical testing, Pesticides and pests, 
Reporting and recordkeeping requirements, Test guidelines.

    Dated: October 31, 2011.
Lisa P. Jackson,
Administrator.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 158--[AMENDED]

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

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

    2. In 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