UNITED STATES ENVIRONMENTAL PROTECTION
WASHINGTON, D.C. 20460
AGENCY
-N~9 4012
9/27/94
PESTICIDE REGULATION (PR) NOTICE 94-8
THE ADMINISTRATOR
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS
AND REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION: Persons Responsible for Federal Registration and
Reregistration of Pesticide Products
SUBJECT:
Water Soluble Packaging (WSP)
This notice describes the registration requirements for
pesticide products containing water soluble packaging (WSP). EPA
is simplifying and streamlining the requirements for registration
ฐ! Pes^lclde Products using WSP as described in Section II below
Effective_ immediately, WSP will be accepted under the same
registration number as other packaging provided certain conditions
are met. in addition, WSP may be added to an existing registration
via notification rather than by formal amendment. This policy is
intended to encourage the use of WSP because of its potential to
reduce risks for pesticide handlers and to prevent pollution by
reducing the number of conventional pesticide containers requiring
cleaning prior to disposal.
I. SCOPE I
This notice applies to currently registered products
amendments and applications for registration of new products which
are compatible with WSP. j
I
II. POLICY AND REQUIREMENTS !
EPA will approve WSP as a form of packaging under the same
registration number as other packaging for a product if it meets
the following conditions: i
j
1. Any WSP yf ilm or ink proposed for use must have been
previously determined by EPA to be acceptable for such use. Each
constituent component of a WSP film or ink must be individually
approved for use and, if the product is to be registered for food
use, have the appropriate tolerance exemption under 40 CFR 180.1001
(c), (d) or (e). The registrant should provide the trade name and
chemical name (if available) and/or trade name and supplier's name
and address for each proposed WSP film and printing ink. Questions
Printed on Recycled Paper
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I
regarding the acceptability of WSP filler -
Sp^alofnel
Sith the procedures described in PR
87-6.
should not
in accordance
react with the
2. The film(s) and ink(s)
ingredients of the product.
A
I: sBSrss s.r.rf ;p
labeling.
III. PROCEDURES
A. Existing Non-WSP Registration
WSP may be added to an existing registration by notification
ano other changes have been made to tn- labe^ng^r the
confidential statement of formula of this Pr.od^;lB JJ^S
unriP-rstand that if this notification is not consistent witn
Se terms of PR Notice 94-8 and 152.46, then this product may
beeineviolฐationNof FIPRA and I may be subject to -forcement
action and pe/alties under sections 12 and 14 of PIFRA.
"
Any claims of confidentiality "should nbe,
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not be processed as a notification. . i
B. ,New Registration ' ... ;-'. ; |.: < :. '' ' ,;
'-.-- _ . \-~ , - ' ' ' '. v
An applicant for a new registration involving WSP should
comply with Section II. above. | :--:
C. "landing Applications --._' _ ' , :
A Iregistrant who has an application pending "With EPA fpr a
separate registration of a WSP product ' (which.could: be merged, with
an already, registered and identical product);should send a letter
to the appropriate Product Manager withdrawing that-application and
separately submit a notification as described above.
D.- Existing Separate Registrations ,
A registrant who holds-separate WSP and non-WSjP registrations
for an .identical formulation and wishes to combine the
registrations may request voluntary cancellation -pfi the WSP product
and separately'submit a notification to add WSP packaging to, the ;,
non-WSP product. WSP may not .be deleted frcpm a currently
registered product except by amendment in accordance with PR '.Notice
91-1. ' , - . . ' '""'; r . ..;'. ;.. ' _:
E. Final printed labeling ! ,
For each product, final printed labeling should be submitted
either as part of the notification or separately in {accordance with
P.R.. Notice 82-2 before the product .may be ,distributed or sold.
[Note; Final printed labeling and labeling on,a product .ready to
be sold or distributed should contain only those ' use directions
which pertain to the packaging of that product. ' However, all use,
directions for all types of! packaging must appea:r on the-master
label which should'be submitted; with a notification or application
for registration as described in Section II.2.] j,
IV. ADDRESSES ' ' .'.-;' ':..ซ'(
A. Notifications should be sent to; .] .
For US PS Submissions: : ". i ']
- ' - ' 1 . " ', - . .' '" - : ij ~. " '' ' " -'.'''
Document Processing Desk (NOTIF) , ,
Office of Pesticide Programs (7504C)
U.S./Environmental Protection Agency
401/M Street/-S.W. . j
Washington, D.C.. 20460-0001 , j" ... ,
. For Courier Deliveries?: -;. . , j " . .{
Office of Pesticide Programs j
3 ' J
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to:
Document Processing Desk (NOTIF)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, Virginia 22202
B. Applications for clearance of new inerts should be sent
Dr. Tina Levine, Head
Project Coordination Section
Registration Support Branch (7505W)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., S.W.
Washington, D.C. 20460-0001
V. DISTRIBUTION AND SALE
Once EPA has received a notification to add WSP to a
registered product, or has registered a new product with WSP, the
registrant may distribute or sell the product with WSP or other
packaging provided that the labeling bears only those use
directions which apply to the product's packaging type.
VI. COMPLIANCE
Registrants are responsible for the content and accuracy of
labeling and for compliance with labeling requirements.
Registrants that submit notifications which do not comply with this
notice or EPA's requirements may be subject to enforcement action
under FIFRA sections 12 and 14.
VII. ADDITIONAL INFORMATION
For further information about this notice, contact Dr. Tina
Levine, (703) 308-308-8393. For information about registering or
amending a specific product, contact the appropriate Product
Manager.
, Director
ision (7505C)
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