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Notification Procedures for Pesticide Registration Modifications
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: June 26, 1996 (Volume 61, Number 124)]
[Rules and Regulations]
[Page 33039-33041]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn96-11]
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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 If the final rule is withdrawn,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: opp-docket@epamail.epa.gov. 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:
kempter.carlton@epamail.epa.gov.
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:
opp-docket@epamail.epa.gov
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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