[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Proposed Rules]
[Pages 21294-21299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9191]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 158
[EPA-HQ-OPP-2010-0670; FRL-8857-7]
RIN 2070-AJ80
Pesticides; Microbial Pesticide Definitions and Applicability;
Clarification and Availability of Draft Test Guideline for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: As promulgated, EPA's regulations distinguish ``isolates'' and
``strains'' in a confusing and non-obvious manner. This has resulted in
significant uncertainty within the regulated industry. This proposed
rule addresses this problem by proposing new regulatory language that
clarifies the requirements applicable to new strains that are
considered to be new active ingredients under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). EPA is also soliciting comment
on a draft microbial pesticide test guideline, explaining the
deposition of a sample in a nationally recognized culture collection
data requirement, for comment. The revisions proposed in this rule also
include several other minor corrections to words and references. The
changes should enhance the ability of industry to efficiently manage
their microbial pesticide registration submissions.
DATES: Comments must be received on or before July 14, 2011.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0670, 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. 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-
2010-0670. 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 e-
mail. 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 e-
mail comment directly to EPA without going through regulations.gov,
your e-mail 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
[[Page 21295]]
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: Rose Kyprianou, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5354; fax number: (703) 305-5884; e-
mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are a
producer or registrant of a microbial pesticide product. This proposal
also may affect any person or company who might petition the Agency for
a tolerance or an exemption from the requirement of a tolerance for the
residues of a microbial pesticide, holds a pesticide registration with
an existing tolerance or tolerance exemption for a microbial pesticide,
or is interested in obtaining or retaining a tolerance or tolerance
exemption in the absence of a registration (i.e., an import tolerance
or tolerance exemption for a microbial pesticide). Potentially affected
entities may include, but are not limited to:
Pesticide and Other Agricultural Chemical Manufacturing
(NAICS code 325320), e.g., pesticide manufacturers or formulators of
pesticide products, importers, or any person or company who seeks to
register a pesticide or to obtain a tolerance or tolerance exemption
for a pesticide.
Crop Production (NAICS code 111).
Animal Production (NAICS code 112).
Food Manufacturing and Processing (NAICS 311).
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 e-mail. 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. What is EPA's authority for taking this action?
This action is issued under the authority of sections 3, 5, 10, 12,
and 25 of the Federal, Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended, and section 408 of the Federal Food, Drug, and
Cosmetic Act (FFDCA).
III. What action is EPA taking?
EPA is proposing several changes and corrections to the Microbial
Pesticides data requirements (40 CFR part 158, subpart V). Two
revisions are proposed to be made to text found in the Microbial
Pesticides Definition and Applicability section (40 CFR 158.2100). The
first is a correction, replacing ``part'' with ``subpart'' in 40 CFR
158.2100(c)(1). The other is a clarification, involving revisions to 40
CFR 158.2100(c)(2), and is in response to recent confusion over the
distinction between isolates and strains and exactly how EPA is
considering both of these terms. The clarification to 40 CFR
158.2100(c)(2) also proposes to include a requirement for the use of a
unique identifier, as part of the microbial pesticide active ingredient
taxonomic name, to allow for improved identification of company-
specific registered isolates.
In conjunction with the change detailed for 40 CFR 158.2100(c)(2),
EPA is also developing a draft microbial pesticide test guideline
(OCSPP Guideline 885.1250) to explain the data requirement for the
deposition of a sample in a nationally recognized culture collection,
which is found in the tables in 40 CFR 158.2120(c) and 40 CFR
158.2171(c); presently, there is no test guideline referenced in the
tables for this requirement. A copy of this draft test guideline is in
the docket for this action to solicit public comment. Additionally, to
clarify this microbial deposition data requirement, EPA is proposing to
add a test note to the aforementioned tables, emphasizing the need for
the continuing maintenance of a culture deposit to ensure it remains
available in case EPA requests a sample. Finally, EPA is proposing to
remove incorrect references, in 40 CFR 158.2120 and 40 CFR 158.2171, to
a paragraph (e) that does not exist.
The improved clarity and transparency of the information proposed
as changes to 40 CFR part 158, subpart V should enhance the ability of
industry to efficiently manage their microbial pesticide registration
submissions. Applicants may save time and money by understanding the
[[Page 21296]]
standards and interpretations of the definitions for the data that are
needed. Having all required studies and information available to EPA at
the time of application may reduce potential delays in the registration
process, thereby enabling registration of microbial pesticides sooner
and allowing microbial pesticide products to enter the market faster.
IV. Today's Proposed Revisions
A. Correcting the Statement in 40 CFR 158.2100(c)(1)
The Agency believes that 40 CFR 158.2100(c)(1), after replacing
``part'' with ``subpart,'' should read as follows: ``This subpart
applies to microbial pesticides as specified in paragraphs (c)(2), (3),
and (4) of this section.'' This section, as currently presented, could
be misconstrued or interpreted to mean that all of 40 CFR part 158
applies to microbial pesticides and conflicts with the information
presented in 40 CFR 158.1(c)(3).
B. Clarifying the Statement in 40 CFR 158.2100(c)(2)
The preamble of the final rule (71 FR 60988, October 26, 2007),
codifying the provision found at 40 CFR 158.2100(c)(2), explained that
registering a new isolate of an already registered microbial strain did
not necessarily increase the amount of data needed to obtain such a
registration. The following language is from that preamble:
EPA carefully considered the comment raising the issue of
whether an isolate occasionally could be evaluated to satisfy a
subset of data requirements at a higher taxonomic level than strain
level and whether an isolate might sometimes be included as part of
a very similar strain. EPA believes the proposed microbial pesticide
definition applicability provision is sufficiently flexible to
ensure adequate consideration and data on new isolates, while
allowing use of existing data to support registration if similar to
an existing strain that is already registered. The wording of the
provision relating to applicability of the microbial data
requirements reads, ``each new isolate of a microbial pesticide is
treated as a new strain and must be registered independently of any
similar registered microbial pesticide strain and supported by data
required in this subpart.'' This wording does not preclude the
possibility of using data from another isolate to support the
assessment if it can be shown that the two isolates are sufficiently
closely related. In this way, it ensures that each isolate will be
independently considered for registration purposes. The differences
in taxonomy between different microorganism classifications,
particularly for baculoviruses, would make any attempt to further
clarify this provision very complex and potentially confusing as the
systematic nomenclature of these organisms change over time. The
Agency intends to use its best scientific judgment in each instance
to determine if one isolate is sufficiently closely related to
another isolate to allow sharing of data or waiving of data
requirements.
In this action, EPA is proposing new language for 40 CFR
158.2100(c)(2) to clarify that the use of the phrase ``is treated as a
new strain'' was intended to illustrate that a new strain is considered
to be a new active ingredient. EPA believes that this interpretation is
consistent with its discussion in the 2007 final rule preamble and with
how EPA has been implementing this regulation. Moreover, in order to
allow for improved identification of company-specific registered
isolates, these modifications will include a provision requiring use of
a unique identifier as part of the microbial pesticide active
ingredient taxonomic name (e.g., a culture collection deposit
identification number or another unique identifier, such as company
initials followed by a number). Currently registered microbial
pesticide active ingredients would not have to conform to this
identification provision until they go through the registration review
process.
C. Clarifying Particular Information Found in 40 CFR 158.2120 and
158.2171 Through Development of a Draft Test Guideline
In conjunction with the proposed change detailed for 40 CFR
158.2100(c)(2) (see Unit IV.B.), EPA is also developing a draft
microbial pesticide test guideline (OCSPP Guideline 885.1250) to
explain the deposition of a sample in a nationally recognized culture
collection data requirement, which is currently found in the tables in
40 CFR 158.2120(c) and 40 CFR 158.2171(c). Presently, there is no test
guideline referenced in the tables for this requirement. Instead,
information on this data requirement is briefly mentioned at the end of
the Microbial Pesticide Test Guideline for Manufacturing Process (OPPTS
Guideline 885.1200): ``A sample of registered [Microbial Pest Control
Agents] MPCAs is to be maintained on deposit in a nationally recognized
culture collection.'' In 1996, this particular statement was
transferred from the 1989 revision of Subdivision M of the Pesticide
Assessment Guidelines (specifically 151A-11) to the Microbial Pesticide
Test Guideline for Manufacturing Process (OPPTS Guideline 885.1200).
The term ``maintained'' was used because some culture collections will
discard deposits after a certain time if they do not get subsequent
requests to purchase samples from that deposit. In creating a distinct
test guideline for the microbial deposition data requirement, EPA will
provide a more easily found reference that can be added to the data
requirement table. Furthermore, the draft test guideline will make
clear that the deposition requirement is analogous to the submittal of
samples data requirement (OPPTS Guideline 830.1900), which established
that chemical pesticides must be deposited in the EPA National
Pesticide Standard Repository. Some of this background information was
explained in the preamble to the proposed rule for Data Requirements
for Microbial and Biochemical Pesticides (71 FR 12072, March 8, 2006):
f. Submittal of samples. This provision is typically intended to
enable EPA to identify the active ingredient and provide standards
to governmental agencies needing to monitor chemical pesticide
residues and is conditionally required (CR). The Agency proposes to
require (R) these data as a product analysis requirement to be
deposited in a nationally recognized culture collection to allow EPA
to validate strain identity if issues arise (guideline 885.1200).
Since the Agency does not have capacity to store the variety of
microbial pesticides that may be submitted, EPA did not set up a
nationally recognized culture collection. There are several
nationally recognized culture collections in this country (and
abroad) such as the American Type Culture Collection and a microbial
collection maintained in Peoria, Ill., by the USDA. These facilities
have a vast number of microbial and cell cultures that [the
facilities] are dedicated to transferring, maintaining and
identifying. Rather than duplicate this effort, EPA chose to refer
microbial pesticide producers to these facilities who have the
routine expertise to keep and distribute (or protect) microbial
cultures. There is a certain element of required expertise but
really the cost and small number of our microbial pesticides would
make it prohibitively expensive for the Agency to do this collection
rather than direct the companies to these specialized facilities.
To clarify this microbial deposition data requirement, the Agency
is proposing to add a test note to the tables in 40 CFR 158.2120 and 40
CFR 158.2171, emphasizing the need for the continuing maintenance of a
culture deposit to ensure it remains available in case the Agency
requests a sample.
D. Correcting Statements in 40 CFR 158.2120 and 158.2171
The current paragraphs (a) and (b) of both 40 CFR 158.2120 and
158.2171 incorrectly reference a paragraph (e) that does not exist. EPA
proposes to remove these incorrect references. Specifically, EPA
proposes to do the following in 40
[[Page 21297]]
CFR 158.2120 and 158.2171: (1) Revise the last sentence of paragraph
(a) for each of these sections to read as ``Notes that apply to an
individual test and include specific conditions, qualifications, or
exceptions to the designated test are identified in paragraph (d) of
this section'' and (2) remove the last sentence in paragraph (b) for
each of these sections.
V. FIFRA Review Requirements
Pursuant to FIFRA sections 25(a) and (d), EPA has 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, and the U.S. Department of Agriculture
(USDA).
The FIFRA Scientific Advisory Panel (SAP) and the USDA waived
review of this proposed rule. The FIFRA SAP waived its review of this
proposed rule because the significant scientific issues involved have
already been reviewed by the SAP and additional review is not
necessary. The SAP waived its review of this proposed rule on August
17, 2010.
VI. Statutory and Executive Order Reviews
This action only proposes to clarify the existing regulatory text
to allow EPA and stakeholders a clearer understanding of 40 CFR part
158, subpart V. 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 increase existing
costs. As such, this action is not subject to review by the Office of
Management and Budget (OMB) as a ``significant regulatory action''
under Executive Order 12866, entitled Regulatory Planning and Review
(58 FR 51735, October 4, 1993). Nor does it impose or change any
information collection burden that requires additional review by OMB
under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.).
The information collection activities contained in the regulation
are already approved under Information Collection Request (ICR)
instruments related to the submission of data to EPA in order to
establish a tolerance or an exemption from the requirement of a
tolerance currently approved under OMB Control No. 2070-0024 (EPA ICR
No. 0597), the activities associated with the application for a new or
amended registration of a pesticide currently approved under OMB
Control No. 2070-0060 (EPA ICR No. 0277), the activities associated
with the application for an experimental use permit currently approved
under OMB Control No. 2070-0040 (EPA ICR No. 0276), and the activities
associated with the generation of data for regulatory review programs
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 EPA's regulations
in 40 CFR are listed in 40 CFR part 9.
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), EPA hereby certifies that this proposed rule
does not have a significant adverse economic impact on a substantial
number of small entities. This action only proposes to clarify the
existing regulatory text to allow EPA and stakeholders a clearer
understanding of 40 CFR part 158, subpart V. It does not otherwise
propose to amend or impose any other requirements. 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 one 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
that 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). In addition, EPA
interprets Executive Order 13045 as applying only to those regulatory
actions that concern health or safety risks, which is not the case in
this proposed rule.
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).
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).
List of Subjects in 40 CFR Part 158
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 7, 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. Amend Sec. 158.2100 as follows:
a. Revise paragraph (c)(1).
b. Revise paragraph (c)(2).
The revised text reads as follows:
[[Page 21298]]
Sec. 158.2100 Microbial pesticides definition and applicability.
* * * * *
(c) Applicability. (1) This subpart applies to microbial pesticides
as specified in paragraphs (c)(2), (3) and (4) of this section.
(2) Because of the potential for variation in microorganisms, each
new isolate of a microbial pesticide is treated as a new active
ingredient and must be registered independently of any similarly
designated and already registered microbial pesticide active
ingredient. Each new isolate for which registration is sought must have
a unique identifier following the taxonomic name of the microorganism,
and the registration application must be supported by data required in
this subpart. This does not preclude the possibility of using data from
another isolate, provided sufficient similarity is established, to
support registration.
* * * * *
3. Amend Sec. 158.2120 as follows:
a. Revise paragraph (a).
b. Revise paragraph (b).
c. Revise paragraph (c).
d. In paragraph (d), redesignate test notes 1 through 4 as 2
through 5, respectively, and add new test note 1.
The revised and added text reads as follows:
Sec. 158.2120 Microbial pesticides product analysis data requirements
table.
(a) General. Sections 158.100 through 158.130 describe how to use
this table to determine the product analysis data requirements and the
substance to be tested for a particular microbial pesticide. Notes that
apply to an individual test and include specific conditions,
qualifications, or exceptions to the designated test are identified in
paragraph (d) of this section.
(b) Key. R = Required; CR = Conditionally required; NR = Not
required; MP = Manufacturing-use product; EP = End-use product; TEP =
Typical end-use product; TGAI = Technical grade of the active
ingredient; All = All of the above.
(c) Table. The following table shows the data requirements for
microbial pesticides product analysis. The test notes are shown in
paragraph (d) of this section.
Table--Microbial Pesticides Product Analysis Data Requirements
----------------------------------------------------------------------------------------------------------------
Test substance
Guideline No. Data requirement All use ------------------------------------------ Test notes
patterns MP EP
----------------------------------------------------------------------------------------------------------------
Product Chemistry and Composition
----------------------------------------------------------------------------------------------------------------
885.1100........... Product identity. R MP EP ...............
885.1200........... Manufacturing R TGAI and MP TGAI and EP ...............
process.
885.1250........... Deposition of a R TGAI TGAI 1
sample in a
nationally
recognized
culture
collection.
885.1300........... Discussion of R TGAI and MP TGAI and EP ...............
formation of
unintentional
ingredients.
----------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
----------------------------------------------------------------------------------------------------------------
885.1400........... Analysis of R TGAI and MP TGAI and EP 2
samples.
885.1500........... Certification of R MP EP ...............
limits.
----------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
----------------------------------------------------------------------------------------------------------------
830.6302........... Color............ R TGAI TGAI ...............
830.6303........... Physical state... R TGAI TGAI ...............
830.6304........... Odor............. R TGAI TGAI ...............
830.6313........... Stability to R TGAI TGAI ...............
normal and
elevated
temperatures,
metals and metal
ions.
830.6317........... Storage stability R TGAI and MP TGAI and EP ...............
830.6319........... Miscibility...... R MP EP 3
830.6320........... Corrosion R MP EP 4
Characteristics.
830.7000........... pH............... R TGAI TGAI ...............
830.7100........... Viscosity........ R MP EP 5
830.7300........... Density/relative R TGAI TGAI ...............
density/bulk
density
(specific
gravity).
----------------------------------------------------------------------------------------------------------------
(d) * * *
1. Required for each isolate of a microbial pesticide. New isolates
must be deposited with an agreement to ensure that the sample will be
maintained and will not be discarded for the duration of the associated
registration(s).
* * * * *
4. Amend Sec. 158.2171 as follows:
a. Revise paragraph (a).
b. Revise paragraph (b).
c. Revise paragraph (c).
d. In paragraph (d), redesignate test notes 3 through 6 as 4
through 7, respectively and add a new test note 3.
The revised and added text reads as follows:
Sec. 158.2171 Experimental use permit microbial pesticides product
analysis data requirements table.
(a) General. Sections 158.100 through 158.130 describe how to use
this table to determine the product analysis data requirements and the
substance to be tested for a particular microbial pesticide. Notes that
apply to an individual test and include specific conditions,
qualifications, or exceptions to the designated test are identified in
paragraph (d) of this section.
(b) Key. R = Required; CR = Conditionally required; NR = Not
required; MP = Manufacturing-use product; EP = End-use product; TEP =
Typical end-use product; TGAI = Technical grade of the active
ingredient; All = All of the above.
(c) Table. The following table shows the data requirements for
experimental use permit microbial pesticides product analysis. The test
notes are shown in paragraph (d) of this section.
[[Page 21299]]
Table--EUP Microbial Product Analysis Data Requirements
----------------------------------------------------------------------------------------------------------------
Test substance
Guideline No. Data requirement All use ---------------------------------------- Test notes
patterns MP EP
----------------------------------------------------------------------------------------------------------------
Product Chemistry and Composition
----------------------------------------------------------------------------------------------------------------
885.1100.......... Product identity..... R MP EP ...............
885.1200.......... Manufacturing process R TGAI and MP TGAI and EP 1, 2
885.1250.......... Deposition of a R TGAI TGAI 3
sample in a
nationally
recognized culture
collection.
885.1300.......... Discussion of R TGAI and MP TGAI and EP 2
formation of
unintentional
ingredients.
----------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
----------------------------------------------------------------------------------------------------------------
885.1400.......... Analysis of samples.. R TGAI and MP TGAI and EP 2, 4
885.1500.......... Certification of R MP EP ...............
limits.
----------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
----------------------------------------------------------------------------------------------------------------
830.6302.......... Color................ R TGAI TGAI ...............
830.6303.......... Physical state....... R TGAI TGAI ...............
830.6304.......... Odor................. R TGAI TGAI ...............
830.6313.......... Stability to normal R TGAI TGAI ...............
and elevated
temperatures, metals
and metal ions.
830.6317.......... Storage stability.... R TGAI and MP TGAI and EP ...............
830.6319.......... Miscibility.......... R MP EP 5
830.6320.......... Corrosion R MP EP 6
characteristics.
830.7000.......... pH................... R TGAI TGAI ...............
830.7100.......... Viscosity............ R MP EP 7
830.7300.......... Density/relative R TGAI TGAI ...............
density/bulk density
(specific gravity).
----------------------------------------------------------------------------------------------------------------
(d) * * *
3. Required for each isolate of a microbial pesticide. New isolates
must be deposited with an agreement to ensure that the sample will be
maintained and will not be discarded for the duration of the associated
experimental use permit(s).
* * * * *
[FR Doc. 2011-9191 Filed 4-14-11; 8:45 am]
BILLING CODE 6560-50-P