October 1, 1996
PESTICIDE REGULATION (PR) NOTICE 96-6
NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS
AND REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION: Persons Responsible for Registration of Pesticide
Products
SUBJECT: Pet Pesticide Product Label Statements
This notice specifies statements that should be added to the
labels of pesticide products which are registered for use on dogs
and/or cats. The label statements outlined in this notice will
help to ensure that products bear labeling that will reduce the
potential for misuse of pet pesticide products and protect pet
and human health.
I. BACKGROUND
The Environmental Protection Agency (the Agency) has received
reports of adverse reactions as a result of the application of
various types of pesticide products registered for use on dogs
and/or cats. While most of the reports involve exposure to cats,
some involve exposure to dogs and humans. Many of the reported
adverse reactions appear to be the result of product misuse or
accidental exposure to animals. More specifically, some animal
and human adverse reactions appear to be due to overdose or
repeated applications at too frequent intervals, or simultaneous
application of multiple pesticide products to pets and their
environment.
Some adverse effects cited in the reports include
neurological, general systemic, respiratory or gastrointestinal.
Some reports claim animal deaths that mostly involve cats. The
number and similarity of the adverse effects have led the Agency
to conclude that the label changes set out in this notice should
minimize misuse and thus reduce the potential risk of adverse
effects to dogs, cats and humans from the use of pet pesticide
products.
II. POLICY
Based on the adverse effects information currently available
to the Agency concerning dog, cat and human health risks
associated with the use of pesticide products for dogs and/or
cats, the Agency believes that registrants should revise the
product labels for such products to include additional use
directions and other statements described in this notice. The
Agency believes that by including the statements outlined in this
notice on pet pesticide product labels, registrants should
significantly reduce misuse and the related risks of adverse
effects to cats, dogs and humans, which should result in a
reduction of the number of incidents associated with such
products. The Agency also believes that the incremental cost of
such label changes is outweighed by the health benefits of having
comprehensive and appropriate label use directions and other
statements which assure the proper use of pet pesticide products.
III. SCOPE
This notice applies to labeling for pesticide products
registered for use directly on dogs and/or cats.
IV. LABEL STATEMENTS
Labels for all end-use pesticide products registered for use
directly on dogs and/or cats should be amended to include the
following types of statements as necessary in addition to
statements that are currently required on labels. Note that this
notice does not replace more restrictive statements or
information currently required on labels.
1. Direct User to Read Entire Label Before Each Use.
Direct user to read entire label by inserting the
following statement at the top of the rear or side
panel in bold, all caps.
"READ ENTIRE LABEL BEFORE EACH USE."
2. Clearly Indicate Registered Species.
The statement "Read Entire Label Before Each Use"
should be followed immediately by the following
statement in bold and caps:
"USE ONLY ON (DOGS, CATS, or DOGS OR CATS)."
In the case of a large number of misuse incidents
regarding an unregistered use or incidents regarding
specific breeds, then the product label should include:
"Do not use on (specific breed) ."
3. Clarify Reapplication Limitation.
The reapplication statement needs to be product
specific; and the statement should be one of the
following:
(a) "Do not Reapply Product For _____ _____.
(Insert number of day(s), week(s) or
month(s).)"
(b) "Reapply every _____ _____." (Insert number
of day(s), week(s), or month(s).)
(c) "Do Not Repeat Treatment For _____ _____."
(Insert number of day(s), week(s), or
month(s).)
(d) "Repeat every _____ _____." (Insert number
of day(s), week(s) or month(s).)
Note: Efficacy and/or domestic animal safety data
should be taken into consideration in determining the
reapplication limitation.
4. Clearly Indicate Minimum Age Of Animals.
Every product label should have:
"Do Not Use On ______ Under ______ Weeks."
The minimum age may not be less than 12 weeks unless
accepted domestic animal safety data are on file at the
Agency to support use on younger animals.
Note: There are only a few products with data that
would support a younger age than 12 weeks.
5. Include Statement Concerning Debilitated, Aged,
Pregnant or Nursing Animals.
The registrant should adopt the statement below or
submit, cite data/information indicating this statement
(or portion of it) is not needed.
"Consult a veterinarian before using this product
on debilitated, aged, pregnant or nursing
animals."
6. Include Adverse Reaction Information.
All products should have the following precautionary
statements.
"Sensitivities may occur after using ANY pesticide
product for pets. If signs of sensitivity occur
bathe your pet with mild soap and rinse with large
amounts of water. If signs continue, consult a
veterinarian immediately."
Note: In the case of a collar, registrants should
replace the second sentence with:
"If signs of sensitivity occur remove collar and
bathe your pet with mild soap and rinse with large
amounts of water."
7. Include Information for Medicated Animals.
The registrant should adopt the statement below unless
the Agency's evaluation of the data indicates this
statement is not needed.
(a) "Certain medications can interact with
pesticides. Consult a veterinarian before
using on medicated animals."; -OR-
(b) Add the following to the label statement
under # 5:
"medicated"; or
"animals on medication."
8. Include A Statement Pertaining to Cholinesterase
Inhibitors.
Products which inhibit cholinesterase should have the
following Precautionary and Practical Treatment (or
First Aid) Statement on label.
(a) "Do not use this product on animals
simultaneously or within 30 days before or
after treatment with or exposure to
cholinesterase inhibiting drugs, pesticides
or chemicals. However, flea and tick collars
may be immediately replaced."; and
(b) Under the First Aid statement, expand the
"Note to Physicians" to include "and
veterinarians"; and include information for
veterinarians.
9. Replace The Label Section Header "Statement of
Practical Treatment" With The Header "First Aid."
Registrants may use either "Statement of Practical
Treatment" or "First Aid."
Note: "First Aid" is preferable for consumer product
labels.
10. Include Telephone Number on Label.
Every product label should have a company or Animal
Poison Control Center, or other telephone number that
consumers may call for the purpose of receiving
information concerning proper use of the product and
specific actions to take in case of emergencies.
V. IMPLEMENTATION OF POLICY
In order to remain in compliance with FIFRA registrants of
products subject to this notice should take either of the
following actions:
(a) Registrants adopting the exact (word for word) label
statements specified in this notice should submit a
notification for each product with a completed
Application for Registration (EPA Form 8570-1). A
photocopy of the EPA application form is acceptable; an
original form is not needed. The application should
bear the following statements:
"Notification of label change per PR Notice 96-6.
This notification is consistent with the provisions of
PR Notice 96-6 and EPA regulations at 40 CFR 152.46,
and no other changes have been made to the labeling or
the confidential statement of formula of this product.
I understand that it is a violation of 18 U.S.C. Sec.
1001 to willfully make any false statement to EPA. I
further understand that if this notification is not
consistent with the terms of PR Notice 96-6 and 40 CFR
152.46, this product may be in violation of FIFRA and I
may be subject to enforcement action and penalties
under sections 12 and 14 of FIFRA."
(b) Registrants who wish to modify the label statements
specified in this PR Notice should submit an
application for amended registration. This application
should include the following items: EPA application
form 8570-1 (filled in), five copies of the draft
label, and a description on the application, such as,
"Amended in accordance with PR Notice 96-6."
Registrants should send notifications and applications for
amendment to the appropriate following address:
U.S. Postal Service Deliveries
The following official mailing address should be used for
all correspondence or data submissions sent to OPP by mail:
Document Processing Desk (AMEND) or (NOTIF) [as applicable]
Office of Pesticide Programs (7504-C)
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460-0001
Personal/Courier Service Deliveries
The following address should be used for all correspondence
or data submissions that are hand-carried or sent by courier
service Monday through Friday, from 8:00 AM to 4:30 PM, excluding
Federal holidays:
Document Processing Desk (AMEND) or (NOTIF) [as applicable]
Office of Pesticide Programs (7504-C)
U.S. Environmental Protection Agency
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, Virginia 22202
As stated above, the Agency believes that the statements
outlined in this notice should reduce adverse effects to pets and
humans. For this reason all products released for shipment by
registrants after October 1, 1998 should bear labeling that is
consistent with this notice. It is the responsibility of
registrants to submit applications or notification in a timely
manner. After these dates, the Agency may either issue a notice
of Intent to Cancel or bring enforcement action against products
not bearing labeling necessary to prevent potential for possible
misuse of pet products and protect pet and human health.
Registrants should submit label changes in a timely manner
so as to meet the October 1st deadline. Adequate review time
should be allowed for amendments that require Agency review and
approval. If only a notification of a labeling change is
submitted, the registrant may send in the notification near the
compliance deadline. If an application for label amendment is
submitted, the registrant will need to allow several months for
EPA's review and additional time for states' reviews.
VI. FOR FURTHER INFORMATION
If you have questions regarding this notice, contact the
Labeling Unit (703-308-8641).
// signed by //
Stephen L. Johnson, Director
Registration Division
http://www.epa.gov/opppmsd1/PR_Notices/pr96-6.html
updated September 18, 1997