Pesticide Data Requirements; Technical Amendments, 61025-61029 [E7-20827]
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TABLE—EUP MICROBIAL PESTICIDES NONTARGET ORGANISMS AND ENVIRONMENTAL FATE DATA REQUIREMENTS
Use Patterns
Terrestrial
Guideline
Number
Aquatic
Data Requirement
Food/
Feed
Forestry
Nonfood
Greenhouse
Indoor
Outdoor
Food/
Feed/
Nonfood
Residential
Food/
Nonfood
Food/
Nonfood
Industrial
Test
Substance
Test
Notes
885.4050
Avian oral
toxicity
NR
R
R
R
R
NR
NR
NR
TGAI
1, 2
885.4200
Freshwater fish toxicity/
pathogenicity
NR
R
R
R
NR
NR
NR
NR
TGAI
1, 2, 3
885.4240
Freshwater invertebrate
toxicity/pathogenicity
NR
R
R
R
NR
NR
NR
NR
TGAI
1, 2, 3
885.4300
Nontarget plant
testing
NR
NR
NR
R
NR
NR
NR
NR
TEP
1, 4
885.4340
Nontarget insect testing
R
R
R
R
NR
NR
NR
NR
TGAI
1, 5
885.4380
Honey bee testing
R
R
R
R
NR
NR
NR
NR
TGAI
1
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(e) Test notes. The following test
notes are applicable to the data
requirements for microbial pesticides
nontarget organism and environmental
fate as referenced in the last column of
the table contained in paragraph (d) of
this section.
1. Tests for pesticides intended solely for
indoor application would be required on a
case-by-case basis, depending on use pattern,
production volume, and other pertinent
factors. Tests to support EUP’s are based on
the application timing and acreage.
2. The preferred species for the avian oral
study is either the upland game or waterfowl.
The preferred species for the avian inhalation
toxicity/pathogenicity study and the avian
chronic toxicity/pathogenicity study is the
upland game. There is also the option to test
a passerine species if there is a concern. The
coldwater fish is preferred for freshwater fish
testing. However, two species (coldwater and
warmwater fish are the preferred species)
must be tested for uses involving direct
freshwater exposure. Freshwater
invertebrates are preferred for invertebrate
testing.
3. Required when there will be significant
exposure to aquatic organisms (fish and
invertebrates).
4. Required if the microbial pesticide is
taxonomically related to a known plant
pathogen.
5. Data are not required unless an active
microbial ingredient controls the target insect
pest by a mechanism of infectivity; i.e. may
create an epizootic condition in nontarget
insects.
[FR Doc. E7–20828 Filed 10–25–07; 8:45 am]
BILLING CODE 6560–50–S
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 152, 156, 159, 160, 168
and 172
[EPA–HQ–OPP–2004–0387; FRL–8114–1]
Pesticide Data Requirements;
Technical Amendments
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This document makes
technical changes and revises cross
references in the Code of Federal
Regulations (CFR) to reflect changes in
pesticide data requirements being
promulgated elsewhere in today’s
Federal Register. These technical
changes are solely to conform other
parts of the CFR to the new rules, and
have no substantive impact on any
requirements. This regulation is a
technical amendment which requires no
opportunity for comment or public
participation.
DATES: This final rule is effective
December 26, 2007.
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2004–0387. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
web site to view the docket index or
access available documents. All
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documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (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
Public Docket, in Rm. S–4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
telephone number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT: Jean
Frane, Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5944; fax number: (703) 305–
5884; e-mail address:
frane.jean@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this Action Apply to Me
You may be potentially affected by
this action if you are a producer or
registrant of a pesticide product. This
action may also affect any person or
company who might petition the
Agency for new tolerances, hold a
pesticide registration with existing
tolerances, or any person or company
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Federal Register / Vol. 72, No. 207 / Friday, October 26, 2007 / Rules and Regulations
who is interested in obtaining or
retaining a tolerance in the absence of
a registration, that is, an import
tolerance. Potentially affected entities
may include, but are not limited to:
• Pesticide Producers (NAICS code
32532), 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 for a pesticide.
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) code has 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 persons listed under FOR FURTHER
INFORMATION CONTACT.
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II. Background
In the Federal Register of March 11,
2005 [70 FR 12276] and March 8, 2006
[71 FR 12072], EPA proposed to amend
pesticide data requirements in 40 CFR
part 158 for conventional pesticides and
for biochemical and microbial
pesticides, respectively. EPA is today
issuing final rules for both proposals. In
order to preserve existing data
requirements for antimicrobial
pesticides, that were contained in part
158, but not proposed for revision, EPA
issued a final rule on October 24, 2007,
transferring the bulk of current part 158
to new part 161. Together part 158 and
part 161 contain the entirety of pesticide
data requirements previously contained
only in part 158.
This final rule makes certain technical
changes and corrects cross-references
elsewhere in pesticide regulations to
conform to new parts 161 and 158. By
issuing a separate technical changes
rule, EPA intends that the promulgation
of the substantive revisions for
conventional, biochemical and
microbial pesticide data requirements
will be straightforward without
confusing technical changes. The key
changes are:
1. Formulators’ Exemption. EPA has
consolidated requirements and policies
for the formulators’ exemption into part
152. EPA has combined existing
material from § 152.85 and § 158.50 in
one location (§ 152.85) and made minor
conforming changes to reflect the
consolidation. The consolidation is
discussed in detail in the final rule for
conventional pesticides.
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2. Cross-reference changes. Crossreferences in parts 152, 156, 159, 160,
168 and 172 are being revised to reflect
the new data requirements structure of
part 158 and part 161. The majority of
these changes reflect the addition of
new part 161 for antimicrobial
pesticides. Others are revised to reflect
the new definition of biochemical or
microbial pesticide.
III. Why are these Technical Revisions
Issued as a Final Rule?
Section 553 of the Administrative
Procedure Act (APA), 5 U.S.C.
553(b)(B), provides that, when an
Agency for good cause finds that notice
and public procedure are impracticable,
unnecessary or contrary to the public
interest, the Agency may issue a final
rule without providing notice and an
opportunity for public comment. EPA
has determined that it is unnecessary to
make today’s rule final without prior
proposal and opportunity for comment,
because EPA is simply making
corrections to cross-references for
accuracy. EPA finds that this constitutes
good cause under 5 U.S.C. 553(b)(B).
IV. Regulatory Assessment
Requirements
This rule makes technical changes
and cross-reference corrections in the
EPA regulations governing pesticides.
The amendments are administrative in
nature and, for the most part, amend the
CFR so that it is consistent with
regulations concerning data
requirements being promulgated
elsewhere in this issue of the Federal
Register. Other than making EPA
regulations more accurate, these
amendments are not expected to have
any impact on regulated parties or the
public.
Accordingly, these amendments are
not subject to review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993), as a significant
regulatory action. Because this rule has
been exempted from review under
Executive Order 12866 due to its lack of
significance, this rule is not subject to
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This rule does not contain
any information collections subject to
OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act of 1995 (UMRA)
(Public Law 104-4). Nor does it require
any special considerations under
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Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or
any Agency action under Executive
Order 13045, entitled Protection of
Children from Environmental Health
Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not
involve any technical standards that
would require Agency consideration of
voluntary consensus standards pursuant
to section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104113, section 12(d) (15 U.S.C. 272 note).
Since this action is not subject to notice
and comment requirements under the
Administrative Procedure Act or any
other statute, it is not subject to the
regulatory flexibility provisions of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq).
In addition, the Agency has
determined that this action will not
have a substantial direct effect on States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive Order to
include regulations that 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.’’ This rule is
directed at pesticide manufacturers and
others who seek to register, amend or
maintain a registration or to establish,
modify, or revoke pesticide tolerances
or exemptions, not States. For these
same reasons, the Agency has
determined that this rule does not have
any ‘‘tribal implications’’ as described
in Executive Order 13175, entitled
Consultation and Coordination with
Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
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Executive Order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
V. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
Agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and the Comptroller General of
the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. This rule is not a
‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 152
Environmental protection,
Administrative practice and procedure,
Pesticides and pests, Reporting and
recordkeeping requirements.
List of Subjects in 40 CFR Part 156
List of Subjects in 40 CFR Part 159
Environmental protection, Pesticides
and pests, Reporting and recordkeeping
requirements.
List of Subjects in 40 CFR Part 160
Environmental protection,
Laboratories, Pesticides and pests,
Reporting and recordkeeping
requirements.
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PART 152—[AMENDED]
1. The authority citation for part 152
continues to read as follows:
I
Authority: 7 U.S.C. 136–136y. Subpart U is
also issued under 31 U.S.C. 9701.
2. Section 152.20 is amended by
revising paragraph (a)(3) to read as
follows:
I
§ 152.20 Exemptions for pesticides
regulated by another Federal agency.
*
*
*
*
*
(a) * * *
(3) The following biological control
agents are not exempt from FIFRA
requirements:
(i) A eucaryotic microorganism
including, but not limited to, protozoa,
algae and fungi;
(ii) A procaryotic microorganism
including, but not limited to, Eubacteria
and Archaebacteria; or
(iii) A parasitically-replicating
microscopic element, including, but not
limited to, viruses.
*
*
*
*
*
I 3. Section 152.43 is amended by
revising paragraph (b)(4) to read as
follows:
§ 152.43
Alternative formulations.
*
*
*
*
(b) * * *
(4) The analytical method required
under § 158.355 of this chapter must be
suitable for use on both the basic
formulation and the alternate
formulation.
*
*
*
*
*
I 4. Amend § 152.50 in paragraph (f)(1)
by revising the reference to ‘‘FIFRA sec.
3(c)(1)(D)’’ to read ‘‘FIFRA sec.
3(c)(1)(F)’’, and by revising paragraph
(c) and paragraph (f)(2) to read as
follows:
Contents of application.
*
Environmental protection,
Administrative practice and procedure,
Advertising, Exports, Labeling,
Pesticides and pests, Reporting and
recordkeeping requirements.
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Therefore, 40 CFR chapter I is
amended as follows:
I
§ 152.50
List of Subjects in 40 CFR Part 168
16:25 Oct 25, 2007
Dated: October 11, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention,
Pesticides, and Toxic Substances.
*
Environmental protection, Labeling,
Pesticides and pests, Reporting and
recordkeeping requirements.
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List of Subjects in 40 CFR Part 172
Environmental protection,
Intergovernmental relations, Labeling,
Pesticides and pests, Reporting and
recordkeeping requirements, Research.
*
*
*
*
(c) Summary of the application. Each
application must include a list of the
data submitted with the application,
together with a brief description of the
results of the studies. The list of data
submitted may be the same as the list
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61027
required by § 158.32 or § 161.32, as
applicable, of this chapter. The
summary must state that it is releasable
to the public after registration in
accordance with § 152.119.
*
*
*
*
*
(f) * * *
(2) An applicant must furnish any
data specified in part 158 or part 161 of
this chapter, as applicable, of this
chapter which are required by the
Agency to determine that the product
meets the registration standards of
FIFRA sec. 3(c)(5) or (7). Each study
must comply with:
(i) Section 158.32 of this chapter, with
respect to format of data submission.
(ii) Section 158.33 of this chapter,
with respect to studies for which a
claim of trade secret or confidential
business information is made.
(iii) Section 158.34 of this chapter,
with respect to flagging for potential
adverse effects.
(iv) Section 160.12 of this chapter,
with respect to a statement whether
studies were conducted in accordance
with Good Laboratory Practices of part
160.
*
*
*
*
*
I 5. Revise § 152.85 to read as follows:
§ 152.85
Formulators’ exemption.
(a) Statutory provision. FIFRA section
3(c)(2)(D) excuses an applicant from the
requirement to submit or cite data
pertaining to any pesticide contained in
his product that is derived solely from
one or more EPA-registered products
which the applicant purchases from
another person. This provision is
commonly referred to as the
formulators’ exemption.
(b) Applicability of the formulators’
exemption. (1) The formulators’
exemption applies only to data
concerning the purchased product or its
ingredients. These data may include,
but are not limited to, product
chemistry, toxicology, residue
chemistry, exposure, environmental
fate, and ecological effects.
(2) The data to which the formulators’
exemption applies usually will concern
the safety of one or more of the
product’s active ingredients,
specifically, those active ingredients
which are contained in the purchased
product. In general, data for which the
required test substance is the technical
grade of the active ingredient, the pure
active ingredient, the radiolabeled pure
active ingredient, or a typical end-use
product are eligible for the formulators’
exemption.
(3) The formulators’ exemption
generally does not apply to data on the
applicant’s product itself, including the
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safety or efficacy of the product, unless
the composition of the product is
identical to the purchased product. In
general, data for which the required test
substance is the product proposed for
registration are not eligible for the
formulators’ exemption.
(c) Limitation of the formulators’
exemption. EPA interprets FIFRA
section 3(c)(2)(D) as allowing an
applicant to use the formulators’
exemption with respect to data
concerning an ingredient of his product
only if:
(1) The application indicates that the
ingredient’s presence in the product is
attributable solely to the purchase from
another person of an identified,
registered product containing that
ingredient and the use of the purchased
product in formulating the product; and
(2) The purchased product is a
registered manufacturing-use product
whose label does not prohibit its use for
making an end-use product labeled for
any use for which the applicant’s
product will be labeled; or
(3) The purchased product is a
registered end-use product labeled for
each use for which the applicant’s
product will be labeled.
(d) Claiming eligibility for the
exemption. (1) If the product contains
one or more ingredients eligible for the
formulators’ exemption, the applicant
need not comply with the requirements
of §§ 152.90 through 152.96 with respect
to any data requirement pertaining to
such ingredient, provided that he
submits to the Agency a certification
statement containing the following
information (a form for this purpose is
available from the Agency):
(i) Identification of the applicant, and
of the product by EPA registration
number or file symbol.
(ii) Identification of each ingredient in
the pesticide that is eligible for the
formulators’ exemption, and the EPA
registration number of the product that
is the source of that ingredient.
(iii) A statement that the listed
ingredients meet the requirements for
the formulators’ exemption.
(iv) A statement that the applicant has
submitted (either previously or with the
current application) a complete,
accurate and current Confidential
Statement of Formula.
(v) The name, title and signature of
the applicant or his authorized
representative and the date of signature.
(2) An applicant for amended
registration is not required to submit a
new formulators’ exemption statement,
if the current statement in Agency files
is complete and accurate.
(e) Approval of registration.
Notwithstanding FIFRA section
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3(c)(2)(D), EPA will not approve an
application unless there are available to
EPA for its review all data that are
necessary to make the required risk/
benefit finding under FIFRA section
3(c)(5) or section 3(c)(7).
I 6. Revise § 152.90(a)(2) to read as
follows:
§ 152.90
The selective method.
*
*
*
*
*
(a) * * *
(2) If a Registration Standard has not
been issued, or if an issued Registration
Standard does not cover all data
requirements for products containing
the active ingredient in question, the
applicant must list the applicable
requirements as prescribed by 40 CFR
part 158 or part 161, as applicable. All
required (R) studies, and any studies
that could be conditionally required
(CR) based upon composition, use
pattern, or the results of required
studies, are to be listed. The applicant
may demonstrate via the data gap
procedures in § 152.96 that a
conditional requirement need not be
satisfied by the submission or citation of
data at the time of application.
*
*
*
*
*
§ 152.91
[Amended]
7. In § 152.91(b) revise the reference
‘‘40 CFR 158.45’’ to read ‘‘40 CFR
158.45 or 40 CFR 161.45’’.
I 8. Revise § 152.97(a)(2)(iii) to read as
follows:
I
§ 152.97 Rights and obligations of data
submitters.
(a) * * *
(2) * * *
(iii) For each such active ingredient,
the type(s) of study he has previously
submitted (corresponding to Guidelines
reference numbers given in tables in 40
CFR part 158 or part 161, as applicable),
the date of submission, and the EPA
registration number, file symbol, or
other identifying reference for which it
was submitted.
*
*
*
*
*
I 9. Revise § 152.104 to read as follows:
§ 152.104
Completeness of applications.
The applicant is responsible for the
accuracy and completeness of all
information submitted in connection
with the application. The Agency will
review each application to determine
whether it is complete. An application
is incomplete if any pertinent item
specified in § 152.50 has not been
submitted, or has been incorrectly
submitted (for example, data required
by part 158, or part 161 of this chapter,
as applicable, and not submitted in
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accordance with the requirements for
format, claims of confidential business
information, or flagging).
§ 152.107
[Amended]
10. In § 152.107(b)(3) revise the
reference ‘‘§ 158.34 of this chapter’’ to
read ‘‘§ 158.34 or § 161.34 of this
chapter’’.
I 11. Revise § 152.112(d) to read as
follows:
I
§ 152.112 Approval of registration under
FIFRA sec. 3(c)(5).
*
*
*
*
*
(d) The Agency has determined that
the composition of the product is such
as to warrant the proposed efficacy
claims for it, if efficacy data are required
to be submitted by part 158 or part 161,
as applicable, of this chapter for the
product.
*
*
*
*
*
I 12. Revise § 152.403(b) to read as
follows:
§ 152.403
Definitions of fee categories.
*
*
*
*
*
(b) New biochemical and microbial
registration review means review of an
application for registration of a
biochemical or microbial pesticide
product containing a biochemical or
microbial active ingredient not
contained in any other pesticide
product that is registered under FIFRA
at the time the application is made. For
purposes of this subpart, the definitions
of biochemical and microbial pesticides
contained in § 158.2000 and § 158.2100,
respectively, shall apply.
*
*
*
*
*
PART 156—[AMENDED]
13. The authority citation for part 156
continues to read as follows:
I
Authority: 7 U.S.C. 136–136y.
§ 156.208
[Amended]
14. In § 156.208(e)(1) revise the
reference to ‘‘§ 158.390’’ to read
‘‘§ 158.1070 or § 161.390’’.
I
PART 159—[AMENDED]
15. The authority citation for part 159
continues to read as follows:
I
Authority: 7 U.S.C. 136–136y.
§ 159.156
[Amended]
16. Section 159.156 is amended as
follows:
I a. In paragraph (e) revise the reference
to ‘‘§ 158.32 of this chapter’’ to read
‘‘§ 158.32 or § 161.32 of this chapter, as
applicable’’.
I
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61029
b. In paragraph (g) revise the reference
to ‘‘§ 158.33 of this chapter’’ to read
‘‘§ 158.33 or § 161.33 of this chapter, as
applicable’’.
I c. In paragraph (h) revise the reference
to ‘‘§ 158.34 of this chapter’’ to read
‘‘§ 158.34 or § 161.34 of this chapter, as
applicable’’.
I 17. Revise § 159.188(a)(2) to read as
follows:
chemical fate, persistence and residue,
or other characteristics in humans, other
living organisms, or media. The term
‘‘study’’does not include basic
exploratory studies carried out to
determine whether a test substance or a
test method has any potential utility.
*
*
*
*
*
product unregistered and subject to the
requirements of section 17 for
unregistered products. If the new use
added to the label is a food or feed use,
a tolerance must already be established
for the use of that pesticide in or on that
commodity.
*
*
*
*
*
PART 168—[AMENDED]
PART 172—[AMENDED]
§ 159.188 Failure of performance
information.
I
20. The authority citation for part 168
continues to read as follows:
I
I
(a) * * *
(2) A study which indicates that the
pesticide may not perform in
accordance with one or more claims
made by the registrant regarding uses
intended for control of microorganisms
tha may pose a risk to human health,
including any of the public health
antimicrobials identified in part 161 of
this chapter.
*
*
*
*
*
PART 160—[AMENDED]
Authority: 7 U.S.C. 136a, 136c, 136d, 136f,
136j, 136v, 136w; 21 U.S.C. 346a, 348, 371,
Reorganization Plan No. 3 of 1970.
19. In § 160.3, revise the definition for
the term ‘‘Study’’ to read as follows:
I
Definitions.
*
*
*
*
Study means any experiment at one of
more test sites, in which a test substance
is studied in a test system under
laboratory conditions or in the
environment to determine or help
predict its effects, metabolism, product
performance (efficacy studies only as
required by 40 CFR 158.400 or 161.640,
as applicable), environmental and
pwalker on PROD1PC71 with RULES
*
VerDate Aug<31>2005
18:30 Oct 25, 2007
21. Section 168.75 is amended by
revising the reference in paragraph
(b)(4)(ii) to ‘‘§ 158.640 of this chapter’’
to read ‘‘§ 158.400 or § 161.640 of this
chapter, as applicable’’, and by revising
paragraph (b)(3)(ii) to read as set
follows:
I
§ 168.75 Procedures for exporting
unregistered pesticides—purchaser
acknowledgement statements.
*
18. The authority citation for part 160
continues to read as follows:
I
§ 160.3
Authority: 7 U.S.C. 136–136y.
Jkt 214001
*
*
*
*
(b) * * *
(3) * * *
(ii) An exporter who is also the
manufacturer of a U.S. registered
pesticide may add new uses to the label
of that product for export purposes,
without triggering the requirements of
section 17(a)(2), as long as the new uses
are within the same general use patterns
as those for the registered product. The
general pesticide use patterns are:
terrestrial food crop and terrestrial nonfood crop; greenhouse food crop and
greenhouse nonfood crop; aquatic food
crop and aquatic nonfood crop’ indoor
use’ and forestry use. Adding new uses
to the label which change the use
pattern, such as changes from nonfood
to food use, outdoor to indoor use, or
terrestrial to aquatic use, render the
PO 00000
Frm 00097
Fmt 4701
Sfmt 4700
22. The Authority citation for part 172
continues to read as follows:
Authority: 7 U.S.C. 136c, 136w. Section
172.4 is also issued under 31 U.S.C. 9701.
23. In § 172.43 revise the definition
for ‘‘microbial pesticide’’ to read as
follows:
I
§ 172.43
Definitions.
*
*
*
*
*
Microbial pesticide means a microbial
agent intended for preventing,
destroying, repelling, or mitigating any
pest, or intended for use as a plant
regulator, defoliant, or desiccant, that:
(1) Is a eucaryotic microorganism
including, but not limited to, protozoa,
algae and fungi;
(2) Is a procaryotic microorganism,
including, but not limited to, Eubacteria
and Archaebacteria; or
(3) Is a parasitically replicating
microscopic element, including, but not
limited to, viruses.
*
*
*
*
*
§ 172.46
[Amended]
24. In § 172.46(c) introductory text,
revise the phrases ‘‘§§ 158.32 and
158.33 of this chapter’’ to read
‘‘§§ 158.32 and 158.33 or 161.31 and
161.33 of this chapter’’
I
[FR Doc. E7–20827 Filed 10–25–07; 8:45 am]
BILLING CODE 6560–50–S
E:\FR\FM\26OCR2.SGM
26OCR2
Agencies
[Federal Register Volume 72, Number 207 (Friday, October 26, 2007)]
[Rules and Regulations]
[Pages 61025-61029]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20827]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 152, 156, 159, 160, 168 and 172
[EPA-HQ-OPP-2004-0387; FRL-8114-1]
Pesticide Data Requirements; Technical Amendments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document makes technical changes and revises cross
references in the Code of Federal Regulations (CFR) to reflect changes
in pesticide data requirements being promulgated elsewhere in today's
Federal Register. These technical changes are solely to conform other
parts of the CFR to the new rules, and have no substantive impact on
any requirements. This regulation is a technical amendment which
requires no opportunity for comment or public participation.
DATES: This final rule is effective December 26, 2007.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2004-0387. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (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
Public Docket, in Rm. S-4400, One Potomac Yard (South Building), 2777
S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
Docket telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Jean Frane, Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-5944; fax
number: (703) 305-5884; e-mail address: frane.jean@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this Action Apply to Me
You may be potentially affected by this action if you are a
producer or registrant of a pesticide product. This action may also
affect any person or company who might petition the Agency for new
tolerances, hold a pesticide registration with existing tolerances, or
any person or company
[[Page 61026]]
who is interested in obtaining or retaining a tolerance in the absence
of a registration, that is, an import tolerance. Potentially affected
entities may include, but are not limited to:
Pesticide Producers (NAICS code 32532), 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 for a pesticide.
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)
code has 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 persons listed under FOR FURTHER INFORMATION CONTACT.
II. Background
In the Federal Register of March 11, 2005 [70 FR 12276] and March
8, 2006 [71 FR 12072], EPA proposed to amend pesticide data
requirements in 40 CFR part 158 for conventional pesticides and for
biochemical and microbial pesticides, respectively. EPA is today
issuing final rules for both proposals. In order to preserve existing
data requirements for antimicrobial pesticides, that were contained in
part 158, but not proposed for revision, EPA issued a final rule on
October 24, 2007, transferring the bulk of current part 158 to new part
161. Together part 158 and part 161 contain the entirety of pesticide
data requirements previously contained only in part 158.
This final rule makes certain technical changes and corrects cross-
references elsewhere in pesticide regulations to conform to new parts
161 and 158. By issuing a separate technical changes rule, EPA intends
that the promulgation of the substantive revisions for conventional,
biochemical and microbial pesticide data requirements will be
straightforward without confusing technical changes. The key changes
are:
1. Formulators' Exemption. EPA has consolidated requirements and
policies for the formulators' exemption into part 152. EPA has combined
existing material from Sec. 152.85 and Sec. 158.50 in one location
(Sec. 152.85) and made minor conforming changes to reflect the
consolidation. The consolidation is discussed in detail in the final
rule for conventional pesticides.
2. Cross-reference changes. Cross-references in parts 152, 156,
159, 160, 168 and 172 are being revised to reflect the new data
requirements structure of part 158 and part 161. The majority of these
changes reflect the addition of new part 161 for antimicrobial
pesticides. Others are revised to reflect the new definition of
biochemical or microbial pesticide.
III. Why are these Technical Revisions Issued as a Final Rule?
Section 553 of the Administrative Procedure Act (APA), 5 U.S.C.
553(b)(B), provides that, when an Agency for good cause finds that
notice and public procedure are impracticable, unnecessary or contrary
to the public interest, the Agency may issue a final rule without
providing notice and an opportunity for public comment. EPA has
determined that it is unnecessary to make today's rule final without
prior proposal and opportunity for comment, because EPA is simply
making corrections to cross-references for accuracy. EPA finds that
this constitutes good cause under 5 U.S.C. 553(b)(B).
IV. Regulatory Assessment Requirements
This rule makes technical changes and cross-reference corrections
in the EPA regulations governing pesticides. The amendments are
administrative in nature and, for the most part, amend the CFR so that
it is consistent with regulations concerning data requirements being
promulgated elsewhere in this issue of the Federal Register. Other than
making EPA regulations more accurate, these amendments are not expected
to have any impact on regulated parties or the public.
Accordingly, these amendments are not subject to review under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993), as a significant regulatory action. Because
this rule has been exempted from review under Executive Order 12866 due
to its lack of significance, this rule is not subject to Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since this action is not subject to notice and
comment requirements under the Administrative Procedure Act or any
other statute, it is not subject to the regulatory flexibility
provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq).
In addition, the Agency has determined that this action will not
have a substantial direct effect on States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999). Executive Order 13132 requires EPA to develop an
accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that 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.'' This rule is directed at pesticide manufacturers and
others who seek to register, amend or maintain a registration or to
establish, modify, or revoke pesticide tolerances or exemptions, not
States. For these same reasons, the Agency has determined that this
rule does not have any ``tribal implications'' as described in
Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive
Order 13175, requires EPA to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' ``Policies that
have tribal implications'' is defined in the
[[Page 61027]]
Executive Order to include regulations that have ``substantial direct
effects on one or more Indian tribes, on the relationship between the
Federal Government and the Indian tribes, or on the distribution of
power and responsibilities between the Federal Government and Indian
tribes.'' This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
V. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 152
Environmental protection, Administrative practice and procedure,
Pesticides and pests, Reporting and recordkeeping requirements.
List of Subjects in 40 CFR Part 156
Environmental protection, Labeling, Pesticides and pests, Reporting
and recordkeeping requirements.
List of Subjects in 40 CFR Part 159
Environmental protection, Pesticides and pests, Reporting and
recordkeeping requirements.
List of Subjects in 40 CFR Part 160
Environmental protection, Laboratories, Pesticides and pests,
Reporting and recordkeeping requirements.
List of Subjects in 40 CFR Part 168
Environmental protection, Administrative practice and procedure,
Advertising, Exports, Labeling, Pesticides and pests, Reporting and
recordkeeping requirements.
List of Subjects in 40 CFR Part 172
Environmental protection, Intergovernmental relations, Labeling,
Pesticides and pests, Reporting and recordkeeping requirements,
Research.
Dated: October 11, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides, and Toxic
Substances.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 152--[AMENDED]
0
1. The authority citation for part 152 continues to read as follows:
Authority: 7 U.S.C. 136-136y. Subpart U is also issued under 31
U.S.C. 9701.
0
2. Section 152.20 is amended by revising paragraph (a)(3) to read as
follows:
Sec. 152.20 Exemptions for pesticides regulated by another Federal
agency.
* * * * *
(a) * * *
(3) The following biological control agents are not exempt from
FIFRA requirements:
(i) A eucaryotic microorganism including, but not limited to,
protozoa, algae and fungi;
(ii) A procaryotic microorganism including, but not limited to,
Eubacteria and Archaebacteria; or
(iii) A parasitically-replicating microscopic element, including,
but not limited to, viruses.
* * * * *
0
3. Section 152.43 is amended by revising paragraph (b)(4) to read as
follows:
Sec. 152.43 Alternative formulations.
* * * * *
(b) * * *
(4) The analytical method required under Sec. 158.355 of this
chapter must be suitable for use on both the basic formulation and the
alternate formulation.
* * * * *
0
4. Amend Sec. 152.50 in paragraph (f)(1) by revising the reference to
``FIFRA sec. 3(c)(1)(D)'' to read ``FIFRA sec. 3(c)(1)(F)'', and by
revising paragraph (c) and paragraph (f)(2) to read as follows:
Sec. 152.50 Contents of application.
* * * * *
(c) Summary of the application. Each application must include a
list of the data submitted with the application, together with a brief
description of the results of the studies. The list of data submitted
may be the same as the list required by Sec. 158.32 or Sec. 161.32,
as applicable, of this chapter. The summary must state that it is
releasable to the public after registration in accordance with Sec.
152.119.
* * * * *
(f) * * *
(2) An applicant must furnish any data specified in part 158 or
part 161 of this chapter, as applicable, of this chapter which are
required by the Agency to determine that the product meets the
registration standards of FIFRA sec. 3(c)(5) or (7). Each study must
comply with:
(i) Section 158.32 of this chapter, with respect to format of data
submission.
(ii) Section 158.33 of this chapter, with respect to studies for
which a claim of trade secret or confidential business information is
made.
(iii) Section 158.34 of this chapter, with respect to flagging for
potential adverse effects.
(iv) Section 160.12 of this chapter, with respect to a statement
whether studies were conducted in accordance with Good Laboratory
Practices of part 160.
* * * * *
0
5. Revise Sec. 152.85 to read as follows:
Sec. 152.85 Formulators' exemption.
(a) Statutory provision. FIFRA section 3(c)(2)(D) excuses an
applicant from the requirement to submit or cite data pertaining to any
pesticide contained in his product that is derived solely from one or
more EPA-registered products which the applicant purchases from another
person. This provision is commonly referred to as the formulators'
exemption.
(b) Applicability of the formulators' exemption. (1) The
formulators' exemption applies only to data concerning the purchased
product or its ingredients. These data may include, but are not limited
to, product chemistry, toxicology, residue chemistry, exposure,
environmental fate, and ecological effects.
(2) The data to which the formulators' exemption applies usually
will concern the safety of one or more of the product's active
ingredients, specifically, those active ingredients which are contained
in the purchased product. In general, data for which the required test
substance is the technical grade of the active ingredient, the pure
active ingredient, the radiolabeled pure active ingredient, or a
typical end-use product are eligible for the formulators' exemption.
(3) The formulators' exemption generally does not apply to data on
the applicant's product itself, including the
[[Page 61028]]
safety or efficacy of the product, unless the composition of the
product is identical to the purchased product. In general, data for
which the required test substance is the product proposed for
registration are not eligible for the formulators' exemption.
(c) Limitation of the formulators' exemption. EPA interprets FIFRA
section 3(c)(2)(D) as allowing an applicant to use the formulators'
exemption with respect to data concerning an ingredient of his product
only if:
(1) The application indicates that the ingredient's presence in the
product is attributable solely to the purchase from another person of
an identified, registered product containing that ingredient and the
use of the purchased product in formulating the product; and
(2) The purchased product is a registered manufacturing-use product
whose label does not prohibit its use for making an end-use product
labeled for any use for which the applicant's product will be labeled;
or
(3) The purchased product is a registered end-use product labeled
for each use for which the applicant's product will be labeled.
(d) Claiming eligibility for the exemption. (1) If the product
contains one or more ingredients eligible for the formulators'
exemption, the applicant need not comply with the requirements of
Sec. Sec. 152.90 through 152.96 with respect to any data requirement
pertaining to such ingredient, provided that he submits to the Agency a
certification statement containing the following information (a form
for this purpose is available from the Agency):
(i) Identification of the applicant, and of the product by EPA
registration number or file symbol.
(ii) Identification of each ingredient in the pesticide that is
eligible for the formulators' exemption, and the EPA registration
number of the product that is the source of that ingredient.
(iii) A statement that the listed ingredients meet the requirements
for the formulators' exemption.
(iv) A statement that the applicant has submitted (either
previously or with the current application) a complete, accurate and
current Confidential Statement of Formula.
(v) The name, title and signature of the applicant or his
authorized representative and the date of signature.
(2) An applicant for amended registration is not required to submit
a new formulators' exemption statement, if the current statement in
Agency files is complete and accurate.
(e) Approval of registration. Notwithstanding FIFRA section
3(c)(2)(D), EPA will not approve an application unless there are
available to EPA for its review all data that are necessary to make the
required risk/benefit finding under FIFRA section 3(c)(5) or section
3(c)(7).
0
6. Revise Sec. 152.90(a)(2) to read as follows:
Sec. 152.90 The selective method.
* * * * *
(a) * * *
(2) If a Registration Standard has not been issued, or if an issued
Registration Standard does not cover all data requirements for products
containing the active ingredient in question, the applicant must list
the applicable requirements as prescribed by 40 CFR part 158 or part
161, as applicable. All required (R) studies, and any studies that
could be conditionally required (CR) based upon composition, use
pattern, or the results of required studies, are to be listed. The
applicant may demonstrate via the data gap procedures in Sec. 152.96
that a conditional requirement need not be satisfied by the submission
or citation of data at the time of application.
* * * * *
Sec. 152.91 [Amended]
0
7. In Sec. 152.91(b) revise the reference ``40 CFR 158.45'' to read
``40 CFR 158.45 or 40 CFR 161.45''.
0
8. Revise Sec. 152.97(a)(2)(iii) to read as follows:
Sec. 152.97 Rights and obligations of data submitters.
(a) * * *
(2) * * *
(iii) For each such active ingredient, the type(s) of study he has
previously submitted (corresponding to Guidelines reference numbers
given in tables in 40 CFR part 158 or part 161, as applicable), the
date of submission, and the EPA registration number, file symbol, or
other identifying reference for which it was submitted.
* * * * *
0
9. Revise Sec. 152.104 to read as follows:
Sec. 152.104 Completeness of applications.
The applicant is responsible for the accuracy and completeness of
all information submitted in connection with the application. The
Agency will review each application to determine whether it is
complete. An application is incomplete if any pertinent item specified
in Sec. 152.50 has not been submitted, or has been incorrectly
submitted (for example, data required by part 158, or part 161 of this
chapter, as applicable, and not submitted in accordance with the
requirements for format, claims of confidential business information,
or flagging).
Sec. 152.107 [Amended]
0
10. In Sec. 152.107(b)(3) revise the reference ``Sec. 158.34 of this
chapter'' to read ``Sec. 158.34 or Sec. 161.34 of this chapter''.
0
11. Revise Sec. 152.112(d) to read as follows:
Sec. 152.112 Approval of registration under FIFRA sec. 3(c)(5).
* * * * *
(d) The Agency has determined that the composition of the product
is such as to warrant the proposed efficacy claims for it, if efficacy
data are required to be submitted by part 158 or part 161, as
applicable, of this chapter for the product.
* * * * *
0
12. Revise Sec. 152.403(b) to read as follows:
Sec. 152.403 Definitions of fee categories.
* * * * *
(b) New biochemical and microbial registration review means review
of an application for registration of a biochemical or microbial
pesticide product containing a biochemical or microbial active
ingredient not contained in any other pesticide product that is
registered under FIFRA at the time the application is made. For
purposes of this subpart, the definitions of biochemical and microbial
pesticides contained in Sec. 158.2000 and Sec. 158.2100,
respectively, shall apply.
* * * * *
PART 156--[AMENDED]
0
13. The authority citation for part 156 continues to read as follows:
Authority: 7 U.S.C. 136-136y.
Sec. 156.208 [Amended]
0
14. In Sec. 156.208(e)(1) revise the reference to ``Sec. 158.390'' to
read ``Sec. 158.1070 or Sec. 161.390''.
PART 159--[AMENDED]
0
15. The authority citation for part 159 continues to read as follows:
Authority: 7 U.S.C. 136-136y.
Sec. 159.156 [Amended]
0
16. Section 159.156 is amended as follows:
0
a. In paragraph (e) revise the reference to ``Sec. 158.32 of this
chapter'' to read ``Sec. 158.32 or Sec. 161.32 of this chapter, as
applicable''.
[[Page 61029]]
0
b. In paragraph (g) revise the reference to ``Sec. 158.33 of this
chapter'' to read ``Sec. 158.33 or Sec. 161.33 of this chapter, as
applicable''.
0
c. In paragraph (h) revise the reference to ``Sec. 158.34 of this
chapter'' to read ``Sec. 158.34 or Sec. 161.34 of this chapter, as
applicable''.
0
17. Revise Sec. 159.188(a)(2) to read as follows:
Sec. 159.188 Failure of performance information.
(a) * * *
(2) A study which indicates that the pesticide may not perform in
accordance with one or more claims made by the registrant regarding
uses intended for control of microorganisms tha may pose a risk to
human health, including any of the public health antimicrobials
identified in part 161 of this chapter.
* * * * *
PART 160--[AMENDED]
0
18. The authority citation for part 160 continues to read as follows:
Authority: 7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136v, 136w; 21
U.S.C. 346a, 348, 371, Reorganization Plan No. 3 of 1970.
0
19. In Sec. 160.3, revise the definition for the term ``Study'' to
read as follows:
Sec. 160.3 Definitions.
* * * * *
Study means any experiment at one of more test sites, in which a
test substance is studied in a test system under laboratory conditions
or in the environment to determine or help predict its effects,
metabolism, product performance (efficacy studies only as required by
40 CFR 158.400 or 161.640, as applicable), environmental and chemical
fate, persistence and residue, or other characteristics in humans,
other living organisms, or media. The term ``study''does not include
basic exploratory studies carried out to determine whether a test
substance or a test method has any potential utility.
* * * * *
PART 168--[AMENDED]
0
20. The authority citation for part 168 continues to read as follows:
Authority: 7 U.S.C. 136-136y.
0
21. Section 168.75 is amended by revising the reference in paragraph
(b)(4)(ii) to ``Sec. 158.640 of this chapter'' to read ``Sec. 158.400
or Sec. 161.640 of this chapter, as applicable'', and by revising
paragraph (b)(3)(ii) to read as set follows:
Sec. 168.75 Procedures for exporting unregistered pesticides--
purchaser acknowledgement statements.
* * * * *
(b) * * *
(3) * * *
(ii) An exporter who is also the manufacturer of a U.S. registered
pesticide may add new uses to the label of that product for export
purposes, without triggering the requirements of section 17(a)(2), as
long as the new uses are within the same general use patterns as those
for the registered product. The general pesticide use patterns are:
terrestrial food crop and terrestrial non-food crop; greenhouse food
crop and greenhouse nonfood crop; aquatic food crop and aquatic nonfood
crop' indoor use' and forestry use. Adding new uses to the label which
change the use pattern, such as changes from nonfood to food use,
outdoor to indoor use, or terrestrial to aquatic use, render the
product unregistered and subject to the requirements of section 17 for
unregistered products. If the new use added to the label is a food or
feed use, a tolerance must already be established for the use of that
pesticide in or on that commodity.
* * * * *
PART 172--[AMENDED]
0
22. The Authority citation for part 172 continues to read as follows:
Authority: 7 U.S.C. 136c, 136w. Section 172.4 is also issued
under 31 U.S.C. 9701.
0
23. In Sec. 172.43 revise the definition for ``microbial pesticide''
to read as follows:
Sec. 172.43 Definitions.
* * * * *
Microbial pesticide means a microbial agent intended for
preventing, destroying, repelling, or mitigating any pest, or intended
for use as a plant regulator, defoliant, or desiccant, that:
(1) Is a eucaryotic microorganism including, but not limited to,
protozoa, algae and fungi;
(2) Is a procaryotic microorganism, including, but not limited to,
Eubacteria and Archaebacteria; or
(3) Is a parasitically replicating microscopic element, including,
but not limited to, viruses.
* * * * *
Sec. 172.46 [Amended]
0
24. In Sec. 172.46(c) introductory text, revise the phrases
``Sec. Sec. 158.32 and 158.33 of this chapter'' to read ``Sec. Sec.
158.32 and 158.33 or 161.31 and 161.33 of this chapter''
[FR Doc. E7-20827 Filed 10-25-07; 8:45 am]
BILLING CODE 6560-50-S