EPA 730-N-97-008
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, DC 20460
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
Fax-On-Demand
Telephone: (202) 401-0527 •
Item: 6103
PESTICIDE REGISTRATION (PR) NOTICE 97-7
Notice to Manufacturers, Producers, Formulators and
Registrants of Pesticides
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.
I. BACKGROUND
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 PR 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,
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Under the President's reinvention program, the Agency has examined the way hi 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:
(1) establish a single compliance date (October 1) by which all registrants and
supplemental distributors will normally adopt labeling changes specified hi PR
Notices or similar notices issued hi a fiscal year;
(2) 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
(3) 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 hi 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 moire
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 OP 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 hi 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
hi PR Notices and similar notices, so that "old" labels hi 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.
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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:
a. Previous experience with the pesticide industry hi general or with a particular
producer indicates that similarly situated products are intended for release.
b. A product is stored hi an area where finished products are held for shipment hi
the ordinary course of business (warehouse, loading docks, etc.). NOTE:
Products that have not been released for shipment, but are stored hi areas where
finished products are held for shipment, must be physically separated and
identified as not yet released for shipment.
c. 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
theur 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 hi this notice will generally not be applied to labeling changes made hi 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 hi the Existing
Stocks Policy.
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n. 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 hi the
notification at any tune 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 hi 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 hi the public interest.
m. IMPLEMENTATION
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 FJUFRA and the Agency's implementing regulations hi 40 CFR Parts 152 and
156. If you have questions regarding this notice, you may contact the Labeling Unit, Field
and External Affairs Division (703)308-9071.
n—
Anne E. Lindsay, Director v-/
Field and External Affairs Division
Office of Pesticide Programs
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