PRN 97-7: Existing Stocks for Labeling Changes in PR Notices
September 19, 1997
Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products
Attention: Persons Responsible for Registration of Pesticide Products
Subject: Existing Stocks for Labeling Changes in PR Notices
This notice describes the Agency's policy to establish an annual compliance date by which registrants and supplemental distributors will normally implement labeling changes specified in PR Notices and similar documents. This notice also specifies existing stocks provisions that will generally be used in PR Notices concerning labeling changes. The policies in this notice are intended to streamline the process for the Agency, registrants and supplemental distributors.
Currently, the Agency specifies compliance dates and existing stocks provisions in PR Notices in accordance with its regulations (40 CFR 152.130(d)) and with its Existing Stocks Policy (56 FR 29362, June 26, 1991). The Agency's regulations specify that when EPA directs that labeling changes be made through issuance of a Registration Standard, a Label Improvement Program (LIP) notice, or a notice concluding a special review process, the Agency will specify the period of time that registrants and others may sell or distribute product bearing previously approved labeling. For purposes of that regulation, EPA considers any PR Notice or Reregistration Eligibility Determination (RED) directing that labeling changes be made to be a "Label Improvement Notice" such that the provisions of 152.130(d) apply. The Existing Stocks Policy describes how long the Agency will generally allow registrants, supplemental distributors and other persons to sell or distribute existing stocks of products subject to a LIP.
Under the President's reinvention program, the Agency has examined the way in which labeling changes in PR Notices are adopted and has looked for ways to make the process more efficient and less burdensome while still maintaining protection to human health and the environment. After evaluating different options, EPA has decided to:
- establish a single compliance date (October 1) by which all registrants and supplemental distributors will normally adopt labeling changes specified in PR Notices or similar notices issued in a fiscal year;
- normally set no compliance date for persons other than registrants and supplemental distributors to sell or distribute products bearing labeling changed in accordance with PR Notices or similar notices; and
- normally require that existing stocks of products (i.e., with old labeling) held by registrants and supplemental distributors be "released for shipment" by the compliance date.
The Agency has decided to establish one annual compliance date (October 1) for EPA-initiated labeling changes so that registrants and supplemental distributors will be able to revise their labels in an orderly fashion. An annual compliance date will also help streamline the Agency's processing of labeling changes, improve the coordination of EPA's labeling activities and lessen the economic impacts on registrants and supplemental distributors of making labeling changes throughout the year. The annual compliance date generally provides more time for registrants and supplemental distributors to distribute or sell products bearing old labeling than under EPA's current Existing Stocks Policy. Under the Existing Stocks Policy, if a LIP Notice is issued, the Agency provided that it would generally allow registrants and supplemental distributors to sell or distribute products bearing old labeling for one year after issuance of the LIP. Under the policy announced in this Notice, however, registrants and supplemental distributors will have as much as two years, including the one year period allotted under the Existing Stocks Policy, to distribute or sell products bearing old labeling. For example, under the new policy, a PR Notice issued on January 1, 1997 would not be effective until October 1, 1998 (22 months from the date of issue) for registrants and supplemental distributors, whereas such PR Notice would be effective January 1, 1998 (one year from the date of issue) for registrants under the Existing Stocks Policy. Therefore, registrants and supplemental distributors would have nine additional months to implement these EPA-initiated labeling changes, compared to the Existing Stocks Policy.
The Agency has determined that generally it will not set a compliance date for persons other than registrants and supplemental distributors to comply with labeling changes specified in PR Notices and similar notices, so that "old" labels in channels of trade are distributed or sold until supplies are exhausted. EPA believes that this approach will reduce unnecessary regulatory burdens while maintaining protection to human health and the environment.
The Agency has determined that the existing stocks provisions will normally be based on the "released for shipment" date. A product is "packaged, labeled, and released for shipment" by a producing establishment when the product has been produced, packaged and labeled, and it is the intent of the producer to introduce such product into commerce. Intent is considered to exist in any of the following situations:
- Previous experience with the pesticide industry in general or with a particular producer indicates that similarly situated products are intended for release.
- A product is stored in an area where finished products are held for shipment in the ordinary course of business (warehouse, loading docks, etc.). NOTE: Products that have not been released for shipment, but are stored in areas where finished products are held for shipment, must be physically separated and identified as not yet released for shipment.
- A producer asserts that the product is ready to be sold or distributed.
The phrase "packaged, labeled, and released for shipment" is only relevant at the producing establishment level. Products at the distributor and retail level have previously been released for shipment by the producing establishment. Keying on this date will allow the Agency to catch products at the earliest point and to deal with products sold on consignment. It will also allow the registrants and supplemental distributors to exercise more control over their inventory. Finally, labeling changes will be implemented without adverse economic consequences while still protecting human health and the environment.
EPA will generally follow these policies unless different measures are necessary to protect human health and the environment, or it is otherwise in the public interest to do so. Thus, at its discretion, the Agency may set a compliance date sooner than October 1, set a compliance date for persons other than registrants and supplemental distributors, or base the compliance date on "distribution or sale" of a product rather than on "released for shipment"
Clearly, for label changes attributed in part to risk concerns under review by the Agency (e.g., special reviews, cancellations, suspensions, reregistration decisions, data call-in notices, etc.), EPA will continue to impose compliance dates for distribution or sale of products by registrants and persons other than registrants. In addition, the annual compliance date set forth in this notice will generally not be applied to labeling changes made in response to these kinds of regulatory decisions. Rather, the Agency will follow its established specific existing stocks provisions for products subject to these actions as described in the Existing Stocks Policy.
Compliance Date For Registrants
The Agency generally intends to establish October 1 as the annual compliance date for EPA-initiated label changes specified by a PR Notice, FR Notice or similar mechanism. EPA will allow at least one year for an action to become effective. If that one year time period ends after October 1, the action becomes effective on the following October 1 compliance date. Registrants should submit label changes in a timely manner so as to meet the October 1st deadline. If only a notification of a labeling change is required, the registrant may send in the notification at any time before the compliance deadline. However, if an application for label amendment is required, the registrant should submit it well in advance of the compliance deadline to allow time for EPA's review and approval.
Compliance Date For Persons Other Than Registrants
Generally, no compliance date will be set for persons other than registrants and supplemental distributors for distribution or sale of existing stocks of "old" labeling.
Released For Shipment
The Agency will generally specify in a PR Notice or similar notice that labeling changes be made on a product prior to its release for shipment by the compliance date.
Exceptions To Policies
EPA may impose different existing stocks provisions than those described above as necessary to protect human health and the environment, or if it is in the public interest.
EPA is adopting the above policies immediately. In making any label changes covered by a PR Notice or similar notice, registrants and supplemental distributors should follow the provisions of that particular notice calling for the label changes, as well as all applicable provisions of FIFRA and the Agency's implementing regulations in 40 CFR Parts 152 and 156.
Anne E. Lindsay, Director
Field and External Affairs Division
Office of Pesticide Programs