Document ID: EPA-HQ-OPP-2008-0247-0001
Agency: epa
Document Type: Rule
Title: Pesticide Regulations; Technical Amendments
Posted Date: 2008-12-12T05:00Z

[Federal Register: December 12, 2008 (Volume 73, Number 240)]
[Rules and Regulations]               
[Page 75592-75600]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12de08-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPP-2008-0247; FRL-8146-6]

 
Pesticide Regulations; Technical Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA has reviewed its pesticide regulations contained in 40 CFR 
Parts 150-180, and is making technical changes in a number of areas. 
These technical changes will correct errors and cross-references, 
improve presentation and format, and conform the regulations to current 
CFR practice. These changes have no substantive impact on any 
requirements. As such, notice and public comment procedures are 
unnecesary, and EPA finds that this constitutes good cause under the 
Administrative Procedure Act.

DATES: This final rule is effective February 10, 2009.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0247. To access the 
electronic docket, go to http://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 website 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 http://
www.regulations.gov, or, if only available in hard copy, at the Office 
of Pesticide Programs (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: Kathryn Boyle, Field and External 
Affairs Division (7506P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6304; fax number: (703) 305-5884; e-
mail address: boyle.kathryn@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    You may be potentially affected by this action if you produce or 
register pesticide products, or petition the Agency to establish or 
modify a pesticide tolerance. Potentially affected entities may 
include, but are not limited to Pesticide Producers (NAICS 32532), 
e.g., pesticide manufacturers or formulators of pesticide products or 
importers of pesticide products.
    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.

II. Background

    Under the Federal Insecticide, Fungicide and Rodenticide Act 
(FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA), the Agency 
regulates the sale, distribution and use of pesticides. EPA regulations 
covering activities under these statutes are contained in 40 CFR parts 
150 - 180. Many of these regulations were promulgated or last revised 
in the 1970s and 1980s and have not been significantly updated.
    Over the past year, EPA has conducted a detailed review of its 
pesticide regulations, contained in 40 CFR parts 150 - 180. EPA 
believes that improvements in these regulations are warranted. Today's 
final rule makes ``housekeeping'' or non-substantive technical changes 
to a series of regulations. Future rulemakings implementing substantive 
changes will be issued as proposed rules with opportunity for comment. 
The types of changes being made today involve error correction, 
conforming changes, and general non-substantive improvements in 
presentation and format.

III. Today's final rule

    In today's final rule EPA is making the following key types 
ofchanges to the regulations in 40 CFR parts 150 - 180.
    1. EPA is removing compliance and effective dates that have 
passed.These involve certain provisions concerning:
    a. Data compensation (part 152, subpart E);
    b. Worker protection interim provisions and exceptions (part 170).
    2. EPA is removing unnecessary or obsolete references, including:
    a. References to the Pesticide Assessment Guidelines that are 
notneeded in regulatory text (part 172);
    b. Definitions related solely to plant-incorporated protectants 
that are not used in the regulatory text of part 152. These definitions 
are duplicative of definitions in part 174.
    c. Reference in Sec.  180.34 to the certification of usefulness, a 
provision eliminated by the Food Quality Protection Act (FQPA) in 1996.
    3. EPA is removing most references to section 409 of the FFDCA. 
Prior to 1996, EPA established tolerances for raw agricultural 
commodities under section 408 and food additive regulations for certain 
pesticide residues in processed foods under section 409, which pertains 
to food additives. As part of the FQPA, Congress combined EPA's 
authority to regulate all pesticide chemical residues in food under 
section 408 of the FFDCA (leaving the Food and Drug Administration the 
sole authority under section 409 to regulate food additives). As it no 
longer has any regulatory authority under section 409, EPA is 
eliminating most references to FFDCA section 409 from its regulations. 
Those retained are needed for continued enforcement of pre-FQPA 
provisions.
    4. EPA is correcting other statutory and regulatory cross-
references.
    a. EPA is correcting the references to data compensation provisions 
in FIFRA sec. 3(c)(1)(D), which is now 3(c)(1)(F).
    b. EPA is correcting the references to FIFRA sec. 4, which is now 
FIFRA sec. 11.
    c. EPA is correcting the regulatory cross-references from Sec.  
156.10(h) to Sec.  156.62 and Sec.  162.11 to part 154. These 
regulations were restructured a number of years ago, but the cross-
references were not.
    5. EPA is correcting part 155, subpart C, Registration Review 
Procedures, to include the mandatory 15-year

[[Page 75593]]

registration review and minor changes to docket procedures required 
under the Pesticide Regulatory Improvement Renewal Act.
    6. EPA is updating organizational and docket references in the 
regulations. For example, EPA is revising a reference to the U.S. 
Bureau of Mines to refer to the National Institute for Occupational 
Safety and Health. EPA is revising the URL for the location of EPA's 
electronic dockets to www.regulations.gov.
    7. EPA is revising the regulations to conform with current CFR 
practice.
    a. EPA is revising the structure used to present definitions. 
Current CFR practice is to list definitions alphabetically without 
numeric or alpha paragraph designations. EPA is revising various 
definitions sections to provide for greater consistency in presentation 
by removing numeric and alpha paragraph designations from parts 154, 
157, 162, 166, and 172. In addition, EPA is standardizing the 
introductory material and, in a few cases, revising a definition from 
``term includes'' or ``term refers to'' to ``term means.'' In each 
instance where EPA is making this revision the existing definition 
contains language that makes the definition all-inclusive, so that the 
term ``includes'' in actuality means ``means.''
    b. EPA is removing the topic headings in part 180, which are no 
longerused in regulations.
    8. EPA is reformatting certain material without substantive change 
for greater clarity and understanding.
    a. EPA is restructuring the opening paragraphs of Sec.  152.1 and 
Sec.  160.1
    b. EPA is revising certain table titles in part 158 to clearly 
identify experimental use permit versus registration data requirements.
    9. EPA is revising section titles to reflect statutory 
language.Specifically, EPA is revising the titles of Sec.  152.10 and 
Sec.  152.20 to accurately reflect the underlying statutory language.

IV. Good Cause Exemption

    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 there is good cause for issuing today's rule final 
without prior proposal and opportunity for comment because notice and 
public comment are unnecessary. EPA is making only technical changes 
that have no substantive effect on any requirement, while improving the 
clarity and usefulness of its regulations. EPA finds that this 
constitutes good cause under 5 U.S.C. 553(b)(B).

V. FIFRA Review Requirements

    In accordance with FIFRA sec. 25(a), a draft of this final rule was 
submitted to the Secretary of Agriculture, the FIFRA SAP, and 
appropriate Congressional Committees. The FIFRA SAP and the Secretary 
of Agriculture waived review of the final rule.

VI. Statutory and Executive Order Reviews

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), this action is not a 
``significant regulatory action'' subject to review by the Office of 
Management and Budget (OMB) under Executive Order 12866, nor does this 
rule contain any information collections subject to OMB approval under 
the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
    Because the Agency has made a ``good cause'' finding that this 
action is not subject to notice-and-comment requirements under the APA 
or any other statute (see Unit IV.), it is not subject to the 
regulatory flexibility provisions of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.), or to sections 202 and 205 of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does this action significantly or uniquely affect small governments or 
impose a significant intergovernmental mandate, as described in 
sections 203 and 204 of UMRA.
    This rule will 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 Executive Order 13132, entitled 
Federalism (64 FR 43255, August 10, 1999), nor will this rule have any 
``tribal implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000).
    This rule does not require any special considerations, 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). Nor will this rule have any affect on energy 
supply, distribution or use as described in Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001).
    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, Public Law 104-113, section 12(d) (15 U.S.C. 272 note). 
The rule also does not involve special consideration of environmental 
justice related issues under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (55 FR 7629, February 16, 1994).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report 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

40 CFR Parts 152 and 154

    Environmental protection, Administrative practice and procedure, 
Pesticides and pest, Reporting and recordkeeping requirements.

40 CFR Part 155

    Environmental protection, Administrative practice and procedure, 
Confidential business information, Pesticides and pest, Reporting and 
recordkeeping requirements.

40 CFR Part 156

    Environmental protection, Administrative practice and procedure, 
labeling, Pesticides and pest, Reporting and recordkeeping 
requirements.

40 CFR Part 157

    Environmental protection, Administrative practice and procedure, 
Infants and children, Packaging and containers, Pesticides and pest, 
Reporting and recordkeeping requirements.

40 CFR Parts 158 and 159

    Environmental protection, Confidential business information, 
Pesticides and pest, Reporting and recordkeeping requirements.

[[Page 75594]]

40 CFR Part 160

    Environmental protection, Laboratories, Pesticides and pest, 
Reporting and recordkeeping requirements.

40 CFR Part 162

    Environmental protection, Administrative practice and procedure, 
Intergovernmental relations, Laboratories, Pesticides and pest.

40 CFR Part 164

    Environmental protection, Administrative practice and procedure, 
Pesticides and pest.

40 CFR Part 166

    Environmental protection, Administrative practice and procedure, 
Intergovernmental relations, Laboratories, Pesticides and pest.

40 CFR Part 168

    Environmental protection, Administrative practice and procedure, 
Advertising, Pesticides and pest.

40 CFR Part 170

    Environmental protection, Intergovernmental relations, Labeling, 
Occupational safety and health, Pesticides and pest.

40 CFR Part 171

    Environmental protection, Indian lands, Intergovernmental 
relations, Laboratories, Pesticides and pest, Reporting and 
recordkeeping requirements.

40 CFR Part 172

    Environmental protection, Intergovernmental relations, Labeling, 
Pesticides and pest, Reporting and recordkeeping requirements, 
Research.

40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Pesticides and pest, Reporting and recordkeeping requirements.

    Dated: December 2, 2008.
James B. Gulliford,
Assistant Administrator for 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. By revising Sec.  152.1 to read as follows:

Sec.  152.1  Scope.

    (a) Part 152 sets forth procedures, requirements and criteria 
concerning the registration of pesticide products under FIFRA section 
3, including plant-incorporated protectants (PIPs). Unless specifically 
superseded by part 174, the regulations in part 152 apply to PIPs.
    (b) Part 152 also describes associated regulatory activities 
affecting registration, as described in this paragraph.
    (1) Data compensation and exclusive use of data in support of 
registration. Refer to subpart E of this part.
    (2) Rights and obligations of registrants. Refer to subpart G of 
this part.
    (3) Classification of pesticide uses. Refer to subpart I of this 
part.
    (4) Fees. Refer to subpart U of this part.
    (5) Requirements pertaining to pesticide devices. Refer to subpart 
Z of this part.

0
3. In Sec.  152.3 by removing the definitions of ``Genetic material 
necessary for the production,'' ``In a living plant,'' ``Noncoding, 
nonexpressed nucleotide sequences,'' ``Pesticidal substance,'' 
``Produce thereof,'' and ``Regulatory region'', and by revising the 
definitions of ``Applicant,'' and subparagraph (1) under the definition 
for ``New use'' to read as follows:

Sec.  152.3  Definitions.

* * * * *
    Applicant means a person who applies for a registration or amended 
registration under FIFRA sec. 3.
* * * * *
    New use * * *
    (1) Any proposed use pattern that would require the establishment 
of, the increase in, or the exemption from the requirement of a 
tolerance or food additive regulation under section 408 of the Federal 
Food, Drug and Cosmetic Act;
* * * * *

0
4. In Sec.  152.6 by revising paragraph (a)(2) to read as follows:

Sec.  152.6  Substances excluded from regulation by FIFRA.

* * * * *
    (a) * * *
    (2) Claims. The product must bear a sterilant claim, or a sterilant 
plus subordinate level disinfection claim. Products that bear 
antimicrobial claims solely at a level less than ``sterilant'' are not 
excluded and are jointly regulated by EPA and FDA.
* * * * *

0
5. By revising the section heading of Sec.  152.10 to readas follows:

Sec.  152.10  Products that are not pesticides because they are not 
intended for a pesticidal purpose.

* * * * *

0
6. By revising the section heading of Sec.  152.20 to readas follows:

Sec.  152.20  Exemptions for pesticides adequately regulated by another 
Federal agency.

* * * * *

0
7. Section 152.50 is amended by revising paragraph (i), and by adding 
paragraph (j) to read as follows:

Sec.  152.50  Contents of application.

* * * * *
    (i) Statement concerning tolerances. (1) If the proposed labeling 
bears instructions for use of the pesticide on food or feed crops, or 
if the intended use of the pesticide results or may be expected to 
result, directly or indirectly, in pesticide chemical residues in or on 
food or feed (including residues of any active ingredient, inert 
ingredient, metabolite, or degradation product), the applicant must 
submit a statement indicating whether such residues are authorized by a 
tolerance or exemption from the requirement of a tolerance issued under 
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA).
    (2) If such residues have not been authorized, the application must 
be accompanied by a petition for establishment of appropriate 
tolerances or exemptions from the requirement of a tolerance, in 
accordance with part 180 of this chapter.
    (j) Fees. (1) The applicant shall identify the appropriate fee 
category in the schedule provided for by FIFRA sec. 33, and shall 
submit the fee for that category as prescribed by the latest EPA notice 
of section 33 fees.
    (2) If FIFRA sec. 33 is not in effect, the applicant shall submit 
any fees required by subpart U of this part, if applicable.

0
8. By revising Sec.  152.80 to read as follows:

Sec.  152.80  General.

    This subpart E describes the information that an applicant must 
submit with his application for registration or amended registration to 
comply (and for the Agency to determine compliance) with the provisions 
of FIFRA sec. 3(c)(1)(F). This subpart also describes the procedures by 
which data submitters may challenge registration actions which 
allegedly failed to comply with these procedures. If the Agency 
determines that an applicant has failed to comply with the requirements 
and procedures in this subpart, the application may be denied. If the 
Agency determines, after

[[Page 75595]]

registration has been issued, that an applicant failed to comply with 
these procedures and requirements, the Agency may issue a notice of 
intent to cancel the product's registration.

Sec.  152.83  [Amended]

0
9. Section 152.83 is amended by removing the alpha paragraph 
designations from the definitions, and revising the reference to 
``FIFRA section 3(c)(1)(D)'' to read ``FIFRA section 3(c)(1)(F)'', 
wherever it appears.

Sec.  152.86  [Amended]

0
10. Section 152.86 is amended by revising the reference ``FIFRA section 
3(c)(1)(D)'' to read ``FIFRA section 3(c)(1)(F)'' wherever it appears.

0
11. Section 152.93 is amended by revising the introductory text of 
paragraph (b)(2), paragraphs (b)(2)(iii) and (b)(3) to read as follows:

Sec.  152.93  Citation of a previously submitted valid study.

* * * * *
    (b) * * *
    (2) Citation with offer to pay compensation to the original data 
submitter. The applicant may cite any valid study that is not subject 
to the exclusive use provisions of FIFRA section 3(c)(1)(F)(i) without 
written authorization from the original data submitter if the applicant 
certifies to the Agency that he has furnished to the original data 
submitter:
* * * * *
    (iii) An offer to pay the person compensation to the extent 
required by FIFRA section 3(c)(1)(F);
* * * * *
    (3) Citation without authorization or offer to pay. The applicant 
may cite any valid study without written authorization from, or offer 
to pay to, the original data submitter if the study was originally 
submitted to the Agency on or before the date that is 15 years before 
the date of the application for which it is cited, and the study is not 
an exclusive use study, as defined in Sec.  152.83(c).

Sec. Sec.  152.94, 152.95, 152.98, and 152.99  [Amended]

0
12. Sections 152.94, 152.95, 152.98, are amended by revising the 
reference ``FIFRA section 3(c)(1)(D)'' to read ``FIFRA section 
3(c)(1)(F)'' and Sec.  152.99 is amended by revising the reference 
``FIFRA section 3(c)(1)(D)(ii)'' to read ``FIFRA section 
3(c)(1)(F)(ii)'' whichever occurs and wherever it occurs.

0
13. By revising Sec.  152.110 to read as follows:

Sec.  152.110  Time for agency review.

    The Agency will complete its review of applications as 
expeditiously as possible. Applications subject to specific timeframes 
under the fee schedule established by FIFRA section 33 will be reviewed 
within the timeframes established for the application or action type.

0
14. In Sec.  152.112 by revising paragraph (d) to read as follows, and 
in paragraph (g), by revising the phrase ``under FFDCA sec. 408, sec. 
409 or both; and'' to read ``under FFDCA sec. 408, and''.

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 for the product by part 158 or part 
161 of this chapter, as applicable.
* * * * *

Sec.  152.116 and Sec.  152.135  [Amended]

0
15. Section 152.116 and 152.135 are amended by revising the reference 
``FIFRA sec. 3(c)(1)(D)(i)'' to read ``FIFRA sec. 3(c)(1)(F)(i)'' or by 
revising the reference ``FIFRA sec. 3(c)(1)(D)'' to read ``FIFRA 
section 3(c)(1)(F)'', whichever occurs and wherever it occurs.

0
16. Section 152.125 is revised to read as follows:

Sec.  152.125  Submission of information pertaining to adverse effects.

    If at any time the registrant receives or becomes aware of any 
factual information regarding unreasonable adverse effects of the 
pesticide on the environment that has not previously been submitted to 
the Agency, the registrant shall, in accordance with FIFRA section 
6(a)(2) and the requirements of part 159, subpart D of this chapter, 
provide such information to the Agency, clearly identified as FIFRA 
6(a)(2) data.

PART 154--[AMENDED]

0
17. The authority citation for part 154 is revised to read as follows:

    Authority: 7 U.S.C. 136a, d, and w.

0
18. Section 154.3 is revised to read as follows:

Sec.  154.3  Definitions.

    Terms used in this part have the same meaning as in the Act. In 
addition, as used in this part, the following terms shall apply:
    Act or FIFRA means the Federal Insecticide, Fungicide, and 
Rodenticide Act, as amended.
    Administrator means the Administrator of the Environmental 
Protection Agency or any officer or employee thereof to whom authority 
has been delegated to act for the Administrator.
    Confidential business information means trade secrets or 
confidential commercial or financial information under FIFRA section 
10(b) or 5 U.S.C. 552(b)(3) or (4).
    Other significant evidence means factually significant information 
that relates to the uses of the pesticide and its adverse risk to man 
or to the environment but does not include evidence based only on 
misuse of the pesticide unless such misuse is widespread and commonly 
recognized practice.
    Person means an applicant, registrant, manufacturer, pesticide 
user, environmental group, labor union, or other individual or group of 
individuals interested in pesticide regulation.
    Pesticide use means a use of a pesticide (described in terms of the 
application site and other applicable identifying factors) that is 
included in the labeling of a pesticide product which is registered, or 
for which an application for registration is pending, and the terms and 
conditions (or proposed terms and conditions) of registration for the 
use.
    Terms and conditions of registration means the terms and conditions 
governing lawful sale, distribution, and use approved in conjunction 
with registration, including labeling, use classification, composition, 
and packaging.
    Validated test means a test determined by the Agency to have been 
conducted and evaluated in a manner consistent with accepted scientific 
procedures.

PART 155--[AMENDED]

0
19. The authority citation for part 155 is revised to read as follows:

    Authority: 7 U.S.C. 136a and 136w.

0
20. By revising Sec.  155.40(a) to read as follows:

Sec.  155.40  General.

    (a) Purpose. These regulations establish procedures for the 
registration review program required in FIFRA section 3(g). 
Registration review is the periodic review of a pesticide's 
registration to ensure that each pesticide registration continues to 
satisfy the FIFRA standard for registration. Under

[[Page 75596]]

FIFRA section 3(g), each pesticide is required to be reviewed every 15 
years.
* * * * *

0
21. By revising Sec.  155.52(a) and (c), to read as follows:

155.52  Stakeholder engagement.

* * * * *
    (a) Minutes of meetings with persons outside of government. Subject 
to paragraph (c) of this section, if the Agency meets with one or more 
individuals that are not government employees to discuss matters 
relating to a registration review, the Agency will place in the docket 
a list of meeting attendees, minutes of the meeting, and any documents 
exchanged at the meeting, not later than the earlier of:
    (1) 45 days after the meeting; or
    (2) The date of issuance of the registration review decision.
* * * * *
    (c) Confidential business information. The Agency will identify, 
but not include in the docket, any confidential business information 
whose disclosure is prohibited by FIFRA section 10.

PART 156--[AMENDED]

0
22. The authority citation for part 156 continues to read as follows:

    Authority: 7 U.S.C. 136 - 136y.

0
23. Section 156.10 is amended by revising paragraphs (i)(2)(ix), and 
(i)(2)(x)(D), and the introductory text of paragraph (j) to read as 
follows:

Sec.  156.10  Labeling requirements.

* * * * *
    (i) * * *
    (2) * * *
    (ix) Specific directions concerning the storage, residue removal 
and disposal of the pesticide and its container, in accordance with 
subpart H of this part. These instructions must be grouped and appear 
under the heading,``Storage and Disposal.'' This heading must be set in 
type of the same minimum sizes as required for the child hazard 
warning. (See table in Sec.  156.60(b))
    (x) * * *
    (D) For total release foggers as defined in Sec.  156.78(d)(1), the 
following statements must be included in the ``Directions for Use.''
* * * * *
    (j) Statement of use classification. Any pesticide product for 
which some uses are classified for general use and others for 
restricted use shall be separately labeled according to the labeling 
standards set forth in this subsection, and shall be marketed as 
separate products with different registration numbers, one bearing 
directions only for general use(s) and the other bearing directions for 
restricted use(s) except that, if a product has both restricted use(s) 
and general use(s), both of these uses may appear on a product labeled 
for restricted use. Such products shall be subject to the provisions of 
paragraph (j)(2) of this section.
* * * * *

0
24. Section 156.200 is amended by revising paragraph (c) to read as 
follows:

Sec.  156.200  Scope and applicability.

* * * * *
    (c) Effective dates. No product to which this subpart applies shall 
be distributed or sold without amended labeling by any registrant after 
April 21, 1994, or by any person after October 23, 1995.

0
25. Section 156.203 is amended by revising the definition of 
``Restricted-entry interval'' to read as follows:

Sec.  156.203  Definitions.

* * * * *
    Restricted-entry interval or REI means the time after the end of a 
pesticide application during which entry to the treated area is 
restricted.

0
26. Section 156.204 is amended by revising paragraph (b) to read as 
follows:

Sec.  156.204  Modification and waiver of requirements.

* * * * *
    (b) Other modifications. The Agency, pursuant to this subpart and 
authorities granted in FIFRA sections 3, 6, and 12, may, on its 
initiative or based on data submitted by any person, modify or waive 
the requirements of this subpart, or permit or require alternative 
labeling statements. Supporting data may be either data conducted 
according to Subdivisions U or K of the Pesticide Assessments 
guidelines or data from medical, epidemiological, or health effects 
studies. A registrant who wishes to modify any of the statements 
required in Sec. Sec.  156.206, 156.208, 156.210, or 156.212 must 
submit an application for amended registration unless specifically 
directed otherwise by the Agency.

Sec. Sec.  156.206, 156.208, 156.210, and 156.212  [Amended]

0
27. Sections 156.206(e), 156.208(c)(1), 156.210(b)(1), and 
156.212(d)(2) are amended by revising the reference ``Sec.  
156.10(h)(l)'' to read ``Sec.  156.62'', wherever it occurs.

PART 157--[AMENDED]

0
28. The authority citation for part 157 continues to read as follows:

    Authority: 7 U.S.C. 136w.

Sec.  157.21  [Amended]

0
29. Section 157.21 is amended by removing the alpha paragraph 
designations from the definitions.

PART 158--[AMENDED]

0
30. The authority citation for part 158 continues to read as follows:

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

Sec.  158.220  [Amended]

0
31. In Sec.  158.220, the title of the table in paragraph (c) is 
revised to read ``Table--Experimental Use Permit Data Requirements for 
Product Performance''.

Sec.  158.230  [Amended]

0
32. In Sec.  158.230, the title of the table in paragraph (c) is 
revised to read ``Table--Experimental Use Permit Toxicity Data 
Requirements.''

Sec.  158.243  [Amended]

0
33. In Sec.  158.243, the title of the table in paragraph (c) is 
revised to read ``Table--Experimental Use Permit Terrestrial and 
Aquatic Nontarget Organism Data Requirements.''

Sec.  158.260  [Amended]

0
34. In Sec.  158.260, the title of the table in paragraph (c) is 
revised to read ``Table--Experimental Use Permit Environmental Fate 
Data Requirements.''

PART 159--[AMENDED]

0
35. The authority citation for part 159 continues to read as follows:

    Authority: 7 U.S.C. 136 - 136y.

0
36. Section 159.153 is amended by revising the introductory text of 
paragraph (b) to read as follows:

Sec.  159.153  Definitions.

* * * * *
    (b) For purposes of reporting information pursuant to FIFRAsection 
6(a)(2), the following definitions apply only to this subpart:
* * * * *

0
37. Section 159.160 is amended by revising paragraph (b)(4) to read as 
follows:

Sec.  159.160  Obligations of former registrants.

* * * * *
    (b) * * *
    (4) The information pertains solely to a formerly registered 
product that no longer meets the definition of ``pesticide'' in section 
2(u) of FIFRA.
* * * * *

[[Page 75597]]

Sec.  159.165  [Amended]

0
38. Section 159.165 is amended in paragraph (a)(2) by revising the 
reference ``40 CFR 156.10(h)'' to read ``40 CFR 156.62'' and in the 
introductory text of paragraph (d)(2) by revising the phrase ``90 
calendar days or less,'' to read ``more than 90 calendar days.''

PART 160--[AMENDED]

0
39. The authority citation for part 160 is revised to read as follows:

    Authority: 7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136t, 136v, 
136w; 21 U.S.C. 346a, 371, Reorganization Plan No. 3 of 1970.

0
40. Section 160.1 is revised to read as follows:

Sec.  160.1  Scope and applicability.

    (a) This part prescribes good laboratory practices for conducting 
studies that support or are intended to support applications for 
research or marketing permits for pesticide products regulated by the 
EPA. This part is intended to assure the quality and integrity of data 
submitted pursuant to sections 3, 4, 5, 8, 18 and 24(c) of the Federal 
Insecticide, Fungicide, and Rodenticide Act, as amended, and section 
408 or 409 of the Federal Food, Drug and Cosmetic Act.
    (b) This part applies to any study described by paragraph (a) of 
this section which any person conducts, initiates, or supports on or 
after October 16, 1989.

0
41. In Sec.  160.3 revise the introductory text of the definition for 
Application for research or marketing permit, and in the same 
definition, revise paragraph (5), and revise the definition for 
``person'' to read as follows:

Sec.  160.3  Definitions.

* * * * *
    Application for research or marketing permit means any of the 
following:
* * * * *
    (5) A petition or other request for establishment or modification 
of a food additive regulation or other clearance by EPA under FFDCA 
section 409 that was submitted prior to August 3, 1996.
* * * * *
    Person means an individual, partnership, corporation, association, 
scientific or academic establishment, government agency or 
organizational unit thereof, or any other legal entity.
* * * * *

PART 162--[AMENDED]

0
42. The authority citation for part 162 continues to read as follows:

    Authority: 7 U.S.C. l36v, 136w.

0
43. Section 162.151 is revised to read as follows:

Sec.  162.151  Definitions.

    Terms used in this part have the same meaning as in the Act and 
part 152 of this chapter. In addition, as used in this subpart, the 
following terms shall apply:
    Federally registered means currently registered under section 3 of 
the Act, after having been initially registered under the Federal 
Insecticide, Fungicide, and Rodenticide Act of 1947 by the Secretary of 
Agriculture or under FIFRA by the Administrator.
    Manufacturing-use product means any pesticide product other than a 
product to be labeled with directions for end use. This term includes 
any product intended for use as a pesticide after reformulation or 
repackaging.
    New product means a pesticide product which is not a federally 
registered product.
    Pest problem means:
    (1) A pest infestation and its consequences, or
    (2) Any condition for which the use of plant regulators, 
defoliants, or desiccants would be appropriate.
    Product or pesticide product means a pesticide offered for 
distribution and use, and includes any labeled container and any 
supplemental labeling.
    Similar composition means a pesticide product which contains only 
the same active ingredient(s), or combinations of active ingredients, 
and which is in the same toxicity category, as defined in Sec.  156.62 
of this chapter, as a federally registered pesticide product.
    Similar product means a pesticide product which, when compared to a 
federally registered product, has a similar composition and a similar 
use pattern.
    Similar use pattern means a use of a pesticide product which, when 
compared to a federally registered use of a product with a similar 
composition, does not require a change in precautionary labeling under 
part 156 of this chapter, and which is substantially the same as the 
federally registered use. Registrations involving changed use patterns 
are not included in this term.
    Special local need means an existing or imminent pest problem 
within a State for which the State lead agency, based upon satisfactory 
supporting information, has determined that an appropriate federally 
registered pesticide product is not sufficiently available.
    State or State lead agency means the State agency designated by the 
State to be responsible for registering pesticides to meet special 
local needs under section 24(c) of the Act.

0
44. Section 162.152 is amended by revising paragraph (b)(1)(i) to read 
as follows:

Sec.  162.152  State registration authority.

* * * * *
    (b) * * *
    (1) * * *
    (i)Subject to the provisions of paragraphs (a) and (b)(1)(ii) 
through (iv) of this section, States may register any new use of a 
federally registered pesticide product.
* * * * *

0
45. Section 162.153 is amended by redesignating paragraph (a)(6) as 
paragraph (j), and by revising the last sentence of paragraph (c)(2) to 
read as follows:

Sec.  162.153  State registration procedures.

* * * * *
    (c) * * *
    (2) * * * Such determinations may also involve consideration of the 
effect of the anticipated classification of the product or use under 
paragraph (g) of this section.
* * * * *

PART 164--[AMENDED]

0
46. The authority citation for part 164 continues to read as follows:

    Authority: 7 U.S.C. 136d.

0
47. Section 164.2 is amended by revising paragraphs (l)(2) and (s) to 
read as follows:

Sec.  164.2  Definitions.

* * * * *
    (l) * * *
    (2) Qualification. A judicial officer shall be a permanent or 
temporary employee or officer of the Agency who may perform other 
duties for the Agency. Such judicial officer shall not be employed by 
the Office of Prevention, Pesticides, and Toxic Substances or have any 
connection with the preparation or presentation of evidence for a 
hearing.
* * * * *
    (s) The term Respondent means the Assistant Administrator of the 
Office of Prevention, Pesticides, and Toxic Substances.
* * * * *

PART 166--[AMENDED]

0
48. The authority citation for part 166 is revised to read as follows:

    Authority: 7 U.S.C. 136p, and 136w.

0
49. Section 166.3 is revised to read as follows:

[[Page 75598]]

Sec.  166.3  Definitions.

    Terms used in this part have the same meaning as in the Act. In 
addition, as used in this part, the following terms shall apply:
    Act means the Federal Insecticide, Fungicide, and Rodenticide Act, 
as amended.
    Agency and EPA mean the U. S. Environmental Protection Agency.
    Beneficial organism means any pollinating insect, or any pest 
predator, parasite, pathogen or other biological control agent which 
functions naturally or as part of an integrated pest management program 
to control another pest.
    Emergency condition means an urgent, non-routine situation that 
requires the use of a pesticide(s) and shall be deemed to exist when:
    (1) No effective pesticides are available under the Act that have 
labeled uses registered for control of the pest under the conditions of 
the emergency; and
    (2) No economically or environmentally feasible alternative 
practices which provide adequate control are available; and
    (3) The situation:
    (i) Involves the introduction or dissemination of an invasive 
species or a pesticide new to or not theretofore known to be widely 
prevalent or distributed within or throughout the United States and its 
territories; or
    (ii) Will present significant risks to human health; or
    (iii) Will present significant risks to threatened or endangered 
species, beneficial organisms, or the environment; or
    (iv) Will cause significant economic loss due to:
    (A) An outbreak or an expected outbreak of a pest; or
    (B) A change in plant growth or development caused by unusual 
environmental conditions where such change can be rectified by the use 
of a pesticide(s).
    First food use means the use of a pesticide on a food or in a 
manner which otherwise would be expected to result in residues in a 
food, if no tolerance or exemption from the requirements of a tolerance 
for residues of the pesticide on any food has been established for the 
pesticide under section 408 of the Federal Food, Drug, and Cosmetic 
Act.
    Food means any article used for food or drink for man or animals.
    Invasive species means, with respect to a particular ecosystem, any 
species that is not native to that ecosystem, and whose introduction 
does or is likely to cause economic or environmental harm or harm to 
human health.
    IR-4 means the Interregional Research Project No. 4, a cooperative 
effort of the state land grant universities, the U.S. Department of 
Agriculture and EPA, to address the chronic shortage of pest control 
options for minor crops, which are generally of too small an acreage to 
provide economic incentive for registration by the crop protection 
industry.
    New chemical means an active ingredient not contained in any 
currently registered pesticide.
    Significant economic loss means that, compared to the situation 
without the pest emergency and despite the best efforts of the affected 
persons, the emergency conditions at the specific use site identified 
in the application are reasonably expected to cause losses meeting any 
of the following criteria:
    (1) For pest activity that primarily affects the current crop or 
other output, one or more of the following:
    (i) Yield loss greater than or equal to 20%.
    (ii) Economic loss, including revenue losses and cost increases, 
greater than or equal to 20% of gross revenues.
    (iii) Economic loss, including revenue losses and cost increases 
greater than or equal to 50% of net revenues.
    (2) For any pest activity where EPA determines that the criteria in 
paragraph (1) of this definition would not adequately describe the 
expected loss, substantial loss or impairment of capital assets, or a 
loss that would affect the long-term financial viability expected from 
the productive activity.
    Special Review means any interim administrative review of the risks 
and benefits of the use of a pesticide conducted pursuant to the 
provisions of part 154 of this chapter, or Sec.  162.11 of this chapter 
prior to November 27, 1985, or any subsequent version of those rules.
    Unreasonable adverse effects on the environment means any 
unreasonable risk to man or the environment, taking into account the 
economic, social, and environmental costs and benefits of the use of 
any pesticide.

PART 168--[AMENDED]

0
50. The authority citation for part 168 continues to read as follows:

    Authority: 7 U.S.C. 136 - 136y.

0
51. Section 168.65 is amended by revising the last sentence of 
paragraph (b)(1)(ii), and paragraph (b)(1)(vii), to read as set forth 
below.

Sec.  168.65  Pesticide export label and labeling requirements.

* * * * *
    (b) * * *
    (1) * * *
    (ii) * * * Where the U.S. warning or caution statement, as 
translated, is obviously inappropriate to protect residents of the 
importing country (for example, where a statement calls for a gas mask 
meeting the specifications of the National Institute of Occupational 
Safety and Health), an equivalent caution must be substituted.
* * * * *
    (vii) Additional warning for highly toxic pesticides. If the 
pesticide, device or active ingredient is highly toxic to humans, the 
skull and crossbones, the word ``Poison,'' and a first aid statement 
must appear on the label. The word ``Poison'' and the first aid 
statement shall be in English and in the appropriate foreign languages, 
as described in paragraph (b)(4) of this section. The skull and 
crossbones may be in red or black. For criteria on what pesticides are 
highly toxic, see Sec.  156.62 of this chapter.
* * * * *

PART 170--[AMENDED]

0
52. The authority citation for part 170 continues to read as follows:

    Authority: 7 U.S.C. 136w.

Sec.  170.5  [Removed]

0
53. Section 170.5 is removed.

Sec.  170.104  [Amended]

0
54. Section 170.104 is amended by revising the acronym ``PPE'' in 
paragraph (b)(2)(iii) to read ``personal protective equipment'' and by 
removing paragraph (c).

Sec.  170.112  [Amended]

0
55. Section 170.112 is amended by removing paragraphs (e)(7)(i) and 
(e)(7)(iv), and by redesignating paragraphs (e)(7)(ii) and (e)(7)(iii) 
as paragraphs (e)(7)(i) and (e)(7)(ii), respectively.

0
56. Section 170.130 is amended by revising paragraph (a)(3)(i) to read 
as follows, by removing paragraph (a)(3)(iii) and by revising paragraph 
(d)(3) to read as follows:.

Sec.  170.130  Pesticide safety training for workers.

    (a) * * *
    (3) * * * (i) Information before entry. Except as provided in 
paragraph (a)(2) of this section, before a worker enters any areas on 
the agricultural establishment where, within the last 30

[[Page 75599]]

days a pesticide to which this subpart applies has been applied or the 
restricted-entry interval for such pesticide has been in effect, the 
agricultural employer shall assure that the worker has been provided 
the pesticide safety information specified in paragraph (c) of this 
section, in a manner that agricultural workers can understand, such as 
by providing written materials or oral communication or by other means. 
The agricultural employer must be able to verify compliance with this 
requirement.
* * * * *
    (d) * * *
    (3) Any person who issues an EPA-approved Worker Protection 
Standard worker training certificate must assure that the worker who 
receives the training certificate has been trained in accordance with 
paragraph (d)(4) of this section.
* * * * *

Sec.  170.204  [Amended]

0
57. Section 170.204 is amended by removing paragraph (c).

PART 171--[AMENDED]

0
58. The authority citation for part 171 is revised to read as follows:

    Authority: 7 U.S.C. 136i and 136w.

0
59. Section 171.2 is amended by revising the introductory text of 
paragraph (a) and by revising paragraph (b)(4) to read as follows:

Sec.  171.2  Definitions.

    (a) Terms used in this subpart have the same meaning as in the Act. 
In addition, the following definitions are applicable to all aspects of 
the certification of pesticide applicator program in this part:
* * * * *
    (b) * * *
    (4) The term uncertified person means any person who is not holding 
a currently valid certification document indicating that he is 
certified under section 11 of FIFRA in the category of the restricted 
use pesticide made available for use.
* * * * *

PART 172--[AMENDED]

0
60. 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
61. Section 172.1 is revised to read as follows

Sec.  172.1  Definitions.

    Terms used in this part have the same meaning as in the Act. In 
addition, as used in this part, the following terms shall apply:
    Act means the Federal Insecticide, Fungicide and Rodenticide Act, 
as amended.
    Applicant means any person who applies for an experimental use 
permit pursuant to section 5 of the Act.
    Cooperator means any person who grants permission to a permittee or 
a permittee's designated participant for the use of an experimental use 
pesticide at an application site owned or controlled by the cooperator.
    Experimental animals means individual animals or groups of animals, 
regardless of species, intended for use and used solely for research 
purposes. The term does not include animals intended to be used for any 
food purposes
    Participant means any person acting as a representative of the 
permittee and responsible for making available for use, or supervising 
the use or evaluation of, an experimental use pesticide to be applied 
at a specific application site.
    Permittee means any applicant to whom an experimental use permit 
has been granted.
    Value for pesticide purposes means that characteristic of a 
substance or mixture of substances which produces an efficacious action 
on a pest.

Sec.  172.3  [Amended]

0
62. Section 172.3(d) is amended by removing the third sentence which 
reads ``Subdivision I of the Pesticide Assessment Guidelines provides 
guidance on the procedures, data requirements, and general aspects 
pertaining to the issuance and use of EUPs.''

0
63. Section 172.4 is amended by revising paragraph (b)(2)(i) and (ii) 
to read as follows:

Sec.  172.4  Applications.

* * * * *
    (b) * * *
    (2) * * *
    (i) Submit evidence that a tolerance or exemption from the 
requirement of a tolerance has been established for residues of the 
pesticide in or on such food or feed under section 408 of the Federal 
Food, Drug, and Cosmetic Act; or
    (ii) Submit a petition proposing establishment of a tolerance or an 
exemption from the requirement of a tolerance under section 408 of the 
Federal Food, Drug, and Cosmetic Act; or
* * * * *

0
64. Section 172.21 is revised to read as follows:

Sec.  172.21  Definitions.

    Terms used in this subpart shall have the meaning set forth in 
FIFRA and in Sec.  172.1.
    Designated State Agency means the State agency designated by State 
law or other authority to be responsible for registering pesticides to 
meet special local needs.
    Public or Private Agricultural Research Agency or Educational 
Institution means any organization engaged in research pertaining to 
the agricultural use of pesticides, or any educational institution 
engaged in pesticide research. Any research agency or educational 
institution whose principal function is to promote, or whose principal 
source of income is directly derived from, the sale or distribution of 
pesticides (or their active ingredients) does not come within the 
meaning of this term.

0
65. Section 172.24 is amended by revising paragraphs (b)(3),(d)(1)(i) 
and (d)(1)(ii) to read as follows:

Sec.  172.24  State issuance of permits.

* * * * *
    (b) * * *
    (3) For use of a restricted use pesticide only if the pesticide is 
to be used by, or under the direct supervision of, an applicator 
certified in accordance with section 11 of FIFRA.
* * * * *
    (d) * * *
    (1) * * *
    (i) A tolerance or exemption from the requirement of a tolerance 
has been established for residues of the pesticide in or on such food 
or feed under section 408 of the Federal Food, Drug and Cosmetic Act; 
and
    (ii) The proposed program would not reasonably be expected to 
result in residues of the pesticide in or on such food or feed in 
excess of that authorized under section 408 of the Federal Food, Drug 
and Cosmetic Act; and
* * * * *

0
66. Section 172.26 is amended by revising paragraph (c)(1)(iii) to read 
as follows:

Sec.  172.26  EPA review of permits.

* * * * *
    (c) * * *
    (1) * * *
    (iii) That new evidence demonstrates that any tolerance upon which 
the permit is based will be inadequate to protect the public health, or 
that any exemption from the requirement for a tolerance is no longer 
appropriate; or
* * * * *

[[Page 75600]]

Sec.  172.46  [Amended]

0
67. In the introductory text to Sec.  172.46(c), revise ``161.31'' to 
read ``161.32.''.

PART 180--[AMENDED]

0
68. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
69. Part 180 is amended as follows:
0
a. By revising the part heading to read ``Tolerances and Exemptions for 
Pesticide Chemical Residues in Food.''
0
b. By removing the center heading that immediately follows the Subpart 
A heading.
0
c. Removing the center heading that immediately follows the Subpart B 
heading.
0
d. By removing the two center headings that immediately precedeSec.  
180.29.

0
70. Section 180.7 is amended by revising the last sentence in paragraph 
(b)(1), the last sentence in paragraph (d) and by revising the next to 
the last sentence in paragraph (f) to read as follows:

Sec.  180.7  Petitions proposing tolerances or exemptions for pesticide 
residues in or on raw agricultural commodities or processed foods.

* * * * *
    (b) * * *
    (1) * * * The electronic copy should be formatted according to the 
Office of Pesticide Programs' current standard for electronic data 
submission as specified at http://www.epa.gov/pesticides/regulating/
registering/submissions/index.htm.
* * * * *
    (d) * * * The Administrator shall make the full text of the summary 
referenced in paragraph (b)(1) of this section available to the public 
in the public docket at http://www.regulations.gov no later than 
publication in the Federal Register of the notice of the petition 
filing.
* * * * *
    (f) * * * The notice shall explicitly reference the specific docket 
identification number in the public docket at http://
www.regulations.gov where the full text of the summary required in 
paragraph (b) of this section is located, and refer interested parties 
to this document for further information on the petition.* * *
* * * * *

0
71. Section 180.34 is amended by revising the introductory text of 
paragraph (e) to read as follows:

Sec.  180.34  Tests on the amount of residue remaining.

* * * * *
    (e) Each of the following groups of crops lists raw agricultural 
commodities that are considered to be related for the purpose of 
paragraph (d) of this section. Commodities not listed in this paragraph 
are not considered to be related for the purpose of paragraph (d) of 
this section.
* * * * *

[FR Doc. E8-29375 Filed 12-11-08; 8:45 am]

BILLING CODE 6560-50-S