This notice has been superseded by CALIFORNIA NOTICE 96-4
CALIFORNIA NOTICE 96-2
TO: Economic Poison Registrants
SUBJECT: CALIFORNIA'S NOTIFICATION PROCESS FOR MINOR
REVISIONS TO PESTICIDE LABELS AND FORMULATIONS
THE PURPOSE OF THIS NOTICE IS TO INFORM REGISTRANTS OF THE
IMPLEMENTATION OF A CALIFORNIA NOTIFICATION PROCESS FOR MINOR
CHANGES TO PESTICIDE LABELING OR FORMULATION. The Department of
Pesticide Regulation's (DPR) process is similar to the
U.S. Environmental Protection Agency's (U.S. EPA) notification
process, but differs in certain areas. This notice will identify
those label changes which can be made through DPR's notification
process, as well as those that do not require notification, and
those that require full review and evaluation as label
Implementation of this procedure is part of our continuing effort
to reduce the amount of time and effort utilized in processing
minor label and formulation changes. This should eliminate
delays in processing minor changes.
Attached is Notification Form #039-031 to be used when submitting
minor label or formulation revisions which meet the notification
criteria. A copy of the federal notification document and other
specified documents are also required to be submitted.
I. LABELING AND FORMULATION REVISIONS WHICH CAN BE MADE BY
NOTIFICATION TO DPR.
A. Deleting Pests or Use Sites. All other labeling
references pertaining to the pest or use site being
deleted must also be deleted. Adding a pest or use
site (except indoor nonfood antimicrobial) cannot be
made by notification. Use deletions related to data
call-ins are also allowed by notification.
B. Adding Indoor Nonfood Sites for Antimicrobial Products
No additional data (such as efficacy, ecological
effects, etc.) are required for the added nonfood site;
Sites are within an already registered use pattern for
A directive does not explicitly prohibit addition of
The technical product label does not prohibit the
The dosage, concentration, frequency, or method of
application do not change.
C. Advisory Statements - Addition, Revision, or Deletion.
Statements such as those related to use precautions,
efficacy, crop damage, and product incompatibility may
be added or revised, provided that they are not
mandatory phrases and do not negate or detract from the
precautionary statements or other label statements.
The addition, deletion, or revision of statements
cannot trigger efficacy, human health, or environmental
concerns, and cannot change the dosage, frequency,
concentration, or method of application. The
statements cannot be false or misleading and cannot
negate or conflict with statements made on any other
product label which refers to use of the subject
product or chemical. Advisory statements may be
Examples of advisory statements include "Product not
recommended on natural marble surfaces" and "This
product should not be used with products containing X
due to risk of explosive reaction."
If you have questions regarding specific advisory
statements, please call the registration specialist
assigned to your company.
D. Changes in Package Size and Net Contents provided all
of the following criteria are met:
Dosage, concentration, frequency, or method of
application do not change;
Exposure is not likely to be increased;
Product is not subject to child resistant packaging
before or after the change;
Product is not a rodenticide. Changes to rodenticide
package size and net contents may not be made through
notification, but require submission as label
No Worker Protection Standard labeling statements are
Package size is not reduced to the point that the net
contents of the package is smaller than the dosage
required by directions for use;
Container size, net contents, or other characteristics
are not changed in a way that violates U.S. EPA-
No changes are made to bait stations, control stations,
attractant stations, or other packaging that houses the
pesticide during its use.
E. Adding Storage and Disposal Statements. The statements
must be in compliance with U.S. EPA PR Notices 83-3
F. Adding Bilingual Labeling. Labeling may be added even
though not required by U.S. EPA. The foreign text must
be a true, complete, and accurate translation of the
English text. Both language versions of the labeling
must appear on a container in their entirety.
G. Adding Symbols and Graphics. Symbols and graphics
cannot substitute for, or conflict with, label text,
and cannot be false or misleading. Examples of
acceptable items include arrow diagrams demonstrating
how to open product containers; graphics displaying
application patterns, such as aerial application,
pictograms displaying various exposure routes, pictures
of where the product can be used, and pictures of
persons wearing appropriate protective clothing.
H. Removal of Redundant Labeling Statements. Statements
may be combined to remove redundancy anywhere on the
label, provided that statements required by DPR or
U.S. EPA are not removed or changed.
I. Changes in Warranty Statement. Warranty statements may
be revised provided they do not disclaim the
performance or safety of the product when used in
accordance with label directions, and are otherwise
consistent with Food and Agricultural Code
sections 12853 and 12854.
J. Changes in Source of Active Ingredient. A change in
the source of an active ingredient is allowed provided
that there is no resulting change in inert ingredients.
The alternate source must be U.S. EPA registered.
K. Other Minor Revisions. Other minor label changes not
described elsewhere in this notice may be made by
notification. These changes must be consistent with
the federal notification requirements.
L. Correcting Typographical and Grammatical Errors. This
includes typographical and printing errors as well as
changes in grammar and phrasing that do not change how
the product will be used.
M. Revision, Addition, or Deletion of Non-FIFRA Related
Label Elements, such as the following:
Symbols and graphics required by other governmental
agencies (i.e., Department of Transportation);
Change in the analysis of a fertilizer product;
Date of manufacture or label approval;
Use of metric units in addition to standard
United States units for net contents, dosages, and
other numeric expressions;
N. Redesign of Label Format. A registrant may redesign a
label's format provided the redesign does not modify
approved label text and is consistent with State and
federal format requirements and policy. This may
include, among other things, changes in color, type
size, or style, use of space, configuration or
placement of label elements.
II. CHANGES THAT CAN BE MADE WITHOUT NOTIFICATION TO DPR
(NOTE: MAY REQUIRE FEDERAL NOTIFICATION)
The source of an inert ingredient may be changed
The source of starting materials for integrated systems
products may be changed without notification;
The formulation process of a product made by a
nonintegrated system may be changed without
III. CHANGES WHICH ARE ALLOWED BY U.S. EPA AS NOTIFICATION
OR NONNOTIFICATION, BUT MUST BE SUBMITTED TO DPR FOR
REVIEW AND APPROVAL AS LABEL AMENDMENTS.
A. Alternate brand names;
B. Addition of any pests;
C. Any increase or decrease in the percentage of an active
D. Any inert ingredient change in identity or
E. Any change in the name or address of the registrant.
IV. SUBMISSION PROCESS FOR NOTIFICATION.
The registrant should identify the submission with a
statement such as "Minor label or formulation change per
CA Notice 96-2" in the cover letter, and attach a completed
Notification Form, #039-031.
Address submissions to:
Notification Project, Pesticide Registration Branch
Department of Pesticide Regulation
1020 N Street, Room 332
Sacramento, CA 95814-5624
Requests may also be hand-carried or courier delivered
Monday through Friday, 8:00 a.m. to 4:30 p.m., excluding
Attach a copy of the federal notification document and any
other documents submitted to U.S. EPA in support of the
federal notification. (There would not be any federal
documents for California-only products since federal
registration is not required.)
For label changes, attach two copies of the final printed
or printer's proof proposed label.
If you are informing us of changes that you have made to
your formulation, attach one copy of the Application for
Registration of Economic Poisons (Pesticides) form with
items 20-29 filled out. In lieu of filling out
items 20-29, you may attach the federal Confidential
Statement of Formula to the application. In either case,
remember to sign and date the application form. In
addition, submit any supporting information, such as
Material Safety Data Sheets, that you have for proposed
V. ADDITIONAL INFORMATION
A. Products distributed or sold with a changed label that
do not meet California's notification criteria are
considered misbranded and subject to enforcement
B. Registrants of California-only products (which do not
require federal registration) may utilize the
notification process for those label changes which meet
C. When change of a labeling or formulation is permissible
by notification, the notification must be received by
DPR before the registrant may distribute or sell the
product with the changed label or formulation. A
product distributed or sold with a changed label before
the notification documents and final printed labels are
received is misbranded.
D. If a registrant has an application for amended
registration pending with DPR which qualifies for
notification pursuant to this notice, the registrant
may: (1) send a letter to the registration specialist
assigned to its company requesting that the application
for amended registration be withdrawn; and (2) submit a
Notification Form and all other required information to
the address above.
VI. QUESTIONS REGARDING THIS NOTICE
If you have questions about this Notice and not about your
specific products, you may call Mr. Richard Bireley in the
Pesticide Registration Branch, at (916) 324-3930. If you have
questions about your specific products, please contact the
registration specialist assigned to your company.
Original Signed by 3-8-96
Barry Cortez, Chief Date
Pesticide Registration Branch
Attachment Notification of Minor Changes