[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Rules and Regulations]
[Pages 33039-33041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16335]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 152

[OPP-300110; FRL-5372-8]
RIN 2070-AC98


Notification Procedures for Pesticide Registration Modifications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule amends EPA's notification and non-notification 
procedures for certain registration modifications. The rule no longer 
specifies the types of modifications that may be accomplished by 
notification or without notification to EPA. The rule provides that EPA 
will issue procedures for notification and non-notification. EPA will 
thereafter designate modifications that may be accomplished through the 
notification and non-notification procedures by notice to registrants. 
This revision will streamline the regulations by eliminating listings 
of very specific modifications, and provide greater flexibility to 
expand the scope of the notification/non-notification process.

DATES: This action is effective on August 26, 1996 unless adverse 
comments are received by July 26, 1996. If the final rule is withdrawn, 
timely notice will be published in the Federal Register.

ADDRESSES: The Agency invites any interested person to submit written 
comments to: By mail: Program Resources Section, Public Response and 
Program Resources Branch, Field Operations Division (7506C), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
In person, bring comments to: Rm. 1132, Crystal Mall #2, 1921 Jefferson 
Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number ``OPP-30110.'' No Confidential Business Information 
(CBI) should be submitted through e-mail. Electronic comments on this 
document may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found in Unit 
VI. of this preamble.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. A copy of the comment that 
does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential may be disclosed publicly 
by EPA without prior notice. All written comments will be available for 
public inspection in Rm. 1132 at the Virginia address given above from 
8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location, telephone 
number, and e-mail address: Rm. 713, CM#2, 1921 Jefferson Davis Hwy., 
Arlington, VA 22202, Telephone: 703-305-5448, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:
    Regulated entities. Entities potentially regulated by this action 
are pesticide producers who register pesticides.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be regulated by this 
action. To determine whether you are subject to regulation by this 
action, you should carefully examine 40 CFR 152.44.

[[Page 33040]]

I. Background

    In March 1995, President Clinton announced a new initiative under 
which all Federal agencies, including EPA, would review their existing 
regulations. This Regulatory Reinvention initiative is intended to 
identify opportunities for streamlining, simplifying, reducing 
reporting and recordkeeping burdens, and promoting partnerships and 
stakeholder involvement in EPA's regulation review.
    In connection with this initiative, EPA has identified changes 
which could be made to its processes for reviewing and approving 
revisions to pesticide registration. One of these changes would be to 
give EPA greater flexibility to permit certain low risk, minor 
modifications to be accomplished by notification or without 
notification rather than by the amendment process. Today's action 
implements those changes to the regulations to provide this 
flexibility.
    The provisions in today's rule affect the process through which the 
Agency approves or permits certain minor modifications to pesticide 
registrations and do not affect the substance of the types of 
amendments which may be made to pesticide registrations. Because EPA 
views this rule as non-controversial, it anticipates no adverse 
comments and is therefore publishing this action without prior 
proposal. If EPA receives such comments, the final rule will be 
withdrawn before the effective date by publishing a subsequent document 
that will withdraw the final action. The public comments received will 
then be addressed in a subsequent final rule or EPA will seek 
additional comments. Any parties interested in commenting on this 
action should do so at this time in accordance with the instructions 
set forth above.

II. Rule Changes

    The significant portion of today's action amends existing 40 CFR 
152.46. Section 152.46 currently provides that the Agency will permit 
registrants to make certain minor changes to their registrations 
without prior Agency review and approval. Section 152.46(a) lists seven 
separate registration actions that may be accomplished by notifying the 
Agency of those changes before the product is distributed or sold. 
These actions are commonly referred to as ``notifications.'' Section 
152.46(b) allows five other minor changes in labeling or packaging to 
be made without notification to the Agency. These actions are commonly 
referred to as ``non-notifications.''
    This rule amends Sec. 152.46 so that it no longer lists the 
specific actions that may be accomplished through notification or non-
notification. Rather, the rule as amended today provides that EPA will 
issue procedures, following an opportunity for public comment, 
specifying the types of registration amendments that may be 
accomplished by notification or non-notification. In fact, these 
procedures were issued following an opportunity for public comment in 
advance of this rule on May 31, 1995, as Pesticide Regulation (PR) 
Notice 95-2, which clarifies and expands the types of registration 
actions that may be made through notification. If EPA changes the 
procedures, it will issue a revised PR Notice (first in draft for 
public comment, then final) and a technical amendment to the rule.
    As with current Sec. 152.46(a), today's amendment continues to 
provide that upon the Agency's receipt of a notification, a registrant 
may distribute or sell the modified product. Similarly, as with current 
Sec. 152.46(b), if the product is modified under the ``non-
notification'' provisions of that section, a registrant is not required 
to notify the Agency before it distributes or sells the modified 
product.
    In addition, consistent with the current Sec. 152.46(a), 
Sec. 152.46(a)(2) of today's amendments provides that EPA may, upon 
receipt of a notification, require the registrant to submit an 
application for amended registration. If it does so, the Agency will 
notify the registrant and request that the registrant submit an 
application for amended registration. If the registrant thereafter 
fails to submit an application, the Agency may determine that the 
product is not in compliance with the requirements of the Act.
    It is important to note that the provision of Sec. 152.46(a)(2) 
described above, as with current Sec. 152.46, only applies to those 
notifications that are consistent with EPA instructions. It reserves 
EPA's right to request registrants to submit applications for amended 
registration for modifications that could otherwise be made through 
notification. It was not intended and does not provide registrants with 
a means to attempt to make modifications to registrations by 
notification that are not permitted by Agency procedures. Accordingly, 
new Sec. 152.46(c) is intended to clarify this point by providing that 
if a registrant modifies a product by notification or non-notification 
in a manner inconsistent with Sec. 152.46(a) and (b) and the procedures 
issued thereunder, the Agency may initiate regulatory and/or 
enforcement action without first providing the registrant with an 
opportunity to submit an application for amended registration.

III. Statutory Review Requirements

    In accordance with FIFRA section 25(a), a copy of this rule was 
provided to appropriate Congressional Committees, the U.S. Department 
of Agriculture and the FIFRA Scientific Advisory Panel.

IV. Public Record

     A record has been established for this rule under docket number 
``OPP-30110'' (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8 a.m. to 
4:30 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Rm. 1132 of the Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:

    [email protected]

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for the rule as well as the public version, as 
described above will be kept in paper form. Accordingly, EPA will 
transfer all comments received electronically into printed, paper form 
as they are received and will place the paper copies in the official 
record which will also include all comments submitted directly in 
writing. The official rulemaking record is the paper record maintained 
at the address in ``ADDRESSES'' at the beginning of this document.

V. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), it has 
been determined that this rule is not ``significant'' and is not 
subject to OMB review.

B. Regulatory Flexibility Act

    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), EPA 
has determined that this regulatory action does not impose any adverse 
economic impacts on small entities. Any comments regarding the economic

[[Page 33041]]

impacts that this regulatory action may impose on small entities should 
be submitted to the Agency at the address listed under the ADDRESSES 
unit.

C. Paperwork Reduction Act

    The information collection requirements contained in this rule have 
been previously approved by the Office of Management and Budget under 
the provisions of the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 
et seq. and have been assigned OMB Control No. 2070-0060. A copy may be 
obtained from the Information Policy Branch (7405), EPA, 401 M St., 
SW., Washington, DC 20460, or by calling (202) 260-2744.

D. Unfunded Mandates

    Under Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4), this action does not result in the expenditure of $100 million 
or more by any State, local or tribal governments, or by anyone in the 
private sector, and will not result in any ``unfunded mandates'' as 
defined by Title II. The costs associated with this action are 
described in the Executive Order 12866 unit above.
    Under Executive Order 12875 (58 FR 58093, October 28, 1993), EPA 
must consult with representatives of affected State, local, and tribal 
governments before promulgating a discretionary regulation containing 
an unfunded mandate. This action does not contain any mandates on 
States, localities or tribes and is therefore not subject to the 
requirements of Executive Order 12875.

E. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act 
(APA) as amended by the Small Business Regulatory Enforcement Fairness 
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted 
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 General Accounting Office prior to publication of the 
rule in today's Federal Register. This rule is not a ``major rule'' as 
defined by 5 U.S.C. 804(2) of the APA as amended.

List of Subjects in Part 152

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

    Dated: June 20, 1996.
Carol M. Browner,
Administrator.

    Therefore, 40 CFR part 152 is amended as follows:

PART 152--[AMENDED]

    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.

    2. Section 152.44 is amended by adding new paragraph (b)(4), to 
read as follows:


Sec. 152.44   Applications for amended registration.

    *    *    *    *    *
    (b)  *  *  *
    (4) Permit an applicant to modify a registration by notification or 
non-notification in accordance with Sec. 152.46.
    3. Section 152.46 is revised to read as follows:


Sec. 152.46   Notification and non-notification changes to 
registrations.

    (a) Changes permitted by notification. (1) EPA may determine that 
certain minor modifications to registration having no potential to 
cause unreasonable adverse effects to the environment may be 
accomplished by notification to the Agency, without requiring that the 
registrant obtain Agency approval. If EPA so determines, it will issue 
procedures following an opportunity for public comment describing the 
types of modifications permitted by notification and any conditions and 
procedures for submitting notifications.
    (2) A registrant may modify a registration consistent with 
paragraph (a)(1) of this section and any procedures issued thereunder 
and distribute or sell the modified product as soon as the Agency has 
received the notification. Based upon the notification, the Agency may 
require that the registrant submit an application for amended 
registration. If it does so, the Agency will notify the registrant and 
state its reasons for requiring an application for amended 
registration. Thereafter, if the registrant fails to submit an 
application the Agency may determine that the product is not in 
compliance with the requirements of the Act. Notification under this 
paragraph is considered a report filed under the Act for the purposes 
of FIFRA section 12(a)(2)(M).
    (b) Changes permitted without notification. EPA may determine that 
certain minor modifications to registration having no potential to 
cause unreasonable adverse effects to the environment may be 
accomplished without notification to or approval by the Agency. If EPA 
so determines, it will issue procedures following an opportunity for 
public comment describing the types of amendments permitted without 
notification (also known as non-notification). A registrant may 
distribute or sell a product changed in a manner consistent with such 
procedures without notification to or approval by the Agency.
    (c) Effect of non-compliance. Notwithstanding any other provision 
of this section, if the Agency determines that a product has been 
modified through notification or without notification in a manner 
inconsistent with paragraphs (a) or (b) of this section and any 
procedures issued thereunder, the Agency may initiate regulatory and/or 
enforcement action without first providing the registrant with an 
opportunity to submit an application for amended registration.

[FR Doc. 96-16335 Filed 6-25-96; 8:45 am]
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