Pesticide Registration (PR) Notice 94-8: Water Soluble Packaging (WSP)
September 27, 1994
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 of pesticide 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.
This notice applies to currently registered products, amendments and applications for registration of new products which are compatible with WSP.
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:
- Any WSP film 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 regarding the acceptability of WSP films or inks should be referred to the contact person listed in Section IV.B. Applications for approval of new WSP films or inks should be submitted in accordance with the procedures described in PR Notice 87-6.
- The film(s) and ink(s) should not react with the ingredients of the product.
- The directions for use on the product label submitted to EPA must provide mixing directions both for WSP and other forms of packaging approved for that product. The product as distributed and sold must bear the appropriate directions for the packaging (WSP or non-WSP). The WSP directions should result in a mixed solution which will be applied at the same dosage (i.e., pounds/per acre, liters/hectare), concentration (ppm, oz./gal, ml/l) and frequency (number of applications permitted over a specified period of time) as approved for other types of packaging for that product.
- At a minimum, labeling of individual WSP units should bear the following:
product name, statement of the active ingredients, signal word, skull
and crossbones (if required), "Keep Out of Reach of Children," EPA registration
number, Restricted Use Statement (if so classified) and a referral statement
to the main label. Labeling of an individual WSP unit is optional if
the WSP is integrally sealed in an outer container that bears appropriate
labeling. III. PROCEDURES
A. Existing Non-WSP Registration
WSP may be added to an existing registration by notification by submitting an Application for Registration (EPA Form 8570-1), a listing of the chemical and/or trade names of the WSP films and/or inks and one copy of the master label containing use directions for WSP and other packaging types as described in Section III.2. above. The notification should contain the following statement:
"I certify that this notification is consistent with the provisions of PR Notice 94-8 and EPA regulations at 152.46 and that no other changes have been made to the labeling or the confidential statement of formula of this product. I further understand that if this notification is not consistent with the terms of PR Notice 94-8 and 152.46, then 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."
Any claims of confidentiality should be made on the application for registration form. Changes in label text related to WSP should be clearly marked so that the changes are legible and can be photocopied. Normally, EPA will screen the notification within 30 days and will inform the registrant if the submission may not be processed as a notification.
B. New Registration
An applicant for a new registration involving WSP should comply with Section II. above.
C. Pending Applications
A registrant who has an application pending with EPA for 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-WSP registrations for an identical formulation and wishes to combine the registrations may request voluntary cancellation of the WSP product and separately submit a notification to add WSP packaging to the non-WSP product. WSP may not be deleted from a currently registered product except by amendment in accordance with PR Notice 91-1.
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 appear on the master label which should be submitted with a notification or application for registration as described in Section II.2.]
A. Notifications should be sent to:
For USPS Submissions:
Document Processing Desk (NOTIF) Office of Pesticide Programs (7504C) U.S. Environmental Protection Agency 401 M Street, S.W.
Washington, D.C. 20460-0001
For Courier Deliveries:
Office of Pesticide Programs 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 to:
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.
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.
Stephen L. Johnson, Director Registration Division (7505C)