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Pesticide Registration (PR) Notice 97-7: Existing Stocks for Labeling Changes in PR Notices
Resources
September 19, 1997
Fax-On-Demand
Phone: (202)401-0527
Item: 6103
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.
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 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:
(1) 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;
(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 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:
a. Previous experience with the pesticide industry in
general or with a particular producer indicates that
similarly situated products are intended for release.
b. 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.
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 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.
II. 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.
III. 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 FIFRA and the
Agency's implementing regulations in 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.
/signed/
Anne E. Lindsay, Director
Field and External Affairs Division
Office of Pesticide Programs