[Federal Register Volume 61, Number 74 (Tuesday, April 16, 1996)]
[Notices]
[Pages 16632-16634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9353]



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ENVIRONMENTAL PROTECTION AGENCY
[OPP-38512; FRL-5363-8]


Existing Stocks of Pesticide Products; Amendment to Statement of 
Policy

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; Amendment to Statement of Policy.

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SUMMARY: In June 1991, EPA published a notice to be used as a guide for 
Agency decision-making regarding the sale, distribution, and use of 
existing stocks of pesticide products whose registrations under the 
Federal, Insecticide, Fungicide, and Rodenticide Act (FIFRA) are 
amended, canceled, or suspended. This Notice announces an amendment to 
the 1991 Notice that the Agency will provide notice and an opportunity 
to comment when it intends to modify the existing stocks provision for 
a canceled pesticide for which the Agency has a risk concern. Except 
for circumstances where the Agency determines that an emergency exists, 
it will provide notice and an opportunity for comment prior to making a 
final determination on modifications to existing stocks provisions. The 
Agency will publish its final decision, findings, and rationale when it 
modifies existing stocks provisions for chemicals of concern.

DATES: This policy takes effect April 16, 1996. Comments must be 
received by May 16, 1996.

ADDRESSES: The Agency invites any interested person who has concerns 
about the implementation of this action to submit written comments in 
triplicate to: By mail: Program Resources Section, Public Response and 
Program Resources Branch, Field Operations Division (7506C), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
In person, bring comments to: Rm. 1132, Crystal Mall #2, 1921 Jefferson 
Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number ``OPP-38512.'' No Confidential Business Information 
(CBI) should be submitted through e-mail. Electronic comments on this 
document may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found in Unit 
IV. of this document.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. A copy of the comment that 
does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential may be disclosed publicly 
by EPA without prior notice. All written comments will be available for 
public inspection in Rm. 1132 at the Virginia address given above from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Richard Dumas, Special Review 
Branch, Special Review and Reregistration Division (7508W), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number, and e-mail address: Special Review 
Branch, 3rd floor, Rm. 3-M, 2800 Crystal Drive, Arlington, VA, (703) 
308-8015, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    This policy statement will help achieve the Agency's goal of 
increasing the degree of public involvement in risk management 
decisions under FIFRA, which was initially articulated in the Federal 
Register notice entitled ``Public Involvement in Significant Risk 
Reduction Decisions on Registered Pesticides'' describing EPA's policy 
on public involvement in significant risk reduction decisions (59 FR 
40905, August 10, 1994). Consistent with that policy, EPA believes that 
in certain circumstances, it is desirable to obtain the views of the 
public before modifying an existing stocks provision.
    On August 15, 1995, the United Farmworkers of America filed suit in 
the U.S. District Court for the District of Columbia, challenging EPA's 
modification of the Mevinphos Cancellation Order, which extended the 
period during which the sales, distribution, and use of existing stocks 
would be permitted to November 30, 1995. As part of its settlement 
agreement, EPA agreed to amend its

[[Page 16633]]

existing stocks policy to permit a greater degree of public involvement 
in its existing stocks dispositions.

II. Background

A. Existing Stocks Policy

    Since 1991, EPA has generally made its decisions concerning the 
disposition of existing stocks of canceled pesticides in accordance 
with the policy entitled ``Existing Stocks of Pesticide Products; 
Statement of Policy'' which was published in the Federal Register of 
June 26, 1991 (56 FR 29362). That Notice established the policies that 
would generally guide EPA in making individual decisions concerning 
whether, and under what conditions, EPA would permit the continued 
sale, distribution, and use of existing stocks of pesticide products 
whose registrations under FIFRA were amended, canceled, or suspended.
    As the 1991 Notice discussed, in making existing stocks 
dispositions, EPA distinguishes between pesticides associated with 
significant risk, and those that are not associated with a significant 
risk. In general, if there are significant risk concerns associated 
with a canceled pesticide, the Agency will not allow continued sale, 
distribution, or use of the product, unless the benefits associated 
with such sale, distribution, or use will exceed the risk. Where there 
are no significant risk concerns associated with the cancellation of a 
pesticide, the Agency will generally allow unlimited use of existing 
stocks, and unlimited sale by persons other than the registrant. In 
such cases, a registrant will generally be allowed to continue to sell 
existing stocks for one year after the date cancellation is requested.

B. Public Involvement in Significant Risk Reduction Decisions

    On August 10, 1994 (59 FR 40905), EPA issued a notice in the 
Federal Register describing its general approach for public involvement 
prior to reaching final significant risk reduction decisions on 
registered pesticides. In that Notice, the Agency reaffirmed its 
commitment to involve the public in the decision making process, gave 
examples of mechanisms that the Agency had used for soliciting public 
comment, and requested public comment on ways to improve its efforts to 
get better public involvement. In that Notice, EPA noted that:

    The Agency understands the importance of public input in 
reaching regulatory decisions, especially input from grower and user 
groups closely associated with a particular pesticide of concern, 
who may provide useful risk and benefit information. . . .Other 
critical information that could be obtained through public input and 
that the Agency views as essential to making effective decisions 
includes human or environmental incident data held by end-user 
groups or other environmental organizations.

III. Amendment to Policy

    This Notice announces that EPA will generally provide public notice 
of, and an opportunity to comment on, proposals to modify the sale, 
distribution and use of the existing stocks of certain pesticides whose 
registrations have been canceled. The policy applies to reductions as 
well as extensions of the period in which existing stocks could be 
sold, distributed, or used. Typically, EPA will provide a 30-day 
comment period. Should the Agency modify the existing stocks 
provisions, EPA will publish its decision and its rationale for the 
amendment.
    This policy would only apply to certain categories of 
modifications, for which EPA determined that public involvement would 
outweigh the increased administrative burden associated with the notice 
and comment process. In general, EPA expects that most frequently it 
will make such a determination in cases involving the existing stocks 
of pesticides associated with a significant risk. In such 
circumstances, the public's interest in being informed of, and in 
participating in, decisions that could result in increased human and 
environmental exposure will generally outweigh the increased 
administrative burden. Additionally, in such circumstances, the public 
input from grower and user groups, and other interested parties closely 
associated with a particular pesticide of concern may provide EPA with 
useful risk and benefit information, such as human or environmental 
incident data.
    For certain categories of modifications, EPA has determined that 
notice and comment would generally be warranted. As a general matter, 
EPA intends to provide an opportunity for notice and comment on 
proposals to modify the existing stocks dispositions for pesticides 
whose registrations were involuntarily canceled pursuant to FIFRA 
section 6(b), and for pesticides whose registrations were voluntarily 
canceled as a result of the issuance of a Notice of Intent to Cancel or 
Notice of Intent to Suspend. In addition, pesticides whose 
registrations were voluntarily canceled following publication of: (a) A 
preliminary notification of intent to initiate a Special Review to 
registrants and applicants for registration, pursuant to 40 CFR 154.21; 
(b) a public announcement of final decision whether or not to initiate 
a Special Review, pursuant 40 CFR 154.25; (c) a Notice of Preliminary 
Determination, pursuant to 40 CFR 154.31; or (d) a Notice of Final 
Determination pursuant to 40 CFR 154.33.
    EPA also intends to apply this policy in other circumstances where, 
in the Agency's exercise of reasoned discretion, the toxicity and 
nature, degree, or amount of exposure to a pesticide during the period 
of the proposed modification, or other information, warrant public 
notice and comment prior to the modification of an existing stocks 
provision. Examples of circumstances that could warrant such notice 
include where the Agency has information that would tend to demonstrate 
a significant risk associated with the product. Such information could 
include circumstances in which EPA has knowledge that a state has 
suspended or canceled a product based on risk concerns, or in which EPA 
has reviewed reports submitted under FIFRA section 6(a)(2), that 
indicate potential risks.
    The absence of information characterizing a significant risk could 
also potentially warrant notice and comment. For example, where little 
data have been submitted on a pesticide product's environmental fate, 
and yet its composition is such that EPA would expect to see some 
degree of persistence and mobility, an opportunity for public notice 
and comment would generally be warranted. In this type of situation, an 
opportunity for public comment could provide input from grower and user 
groups closely associated with the pesticide that might provide useful 
risk and benefit information such as human or environmental incident 
data.
    Existing stocks can arise from a number of actions, such as when, 
during the reregistration process, a registrant chooses to delete a use 
rather than to submit the data necessary to support it, or when, after 
EPA mandates a label change, a registrant has some amount of the 
product with the old label ready and waiting to be released for 
shipment. These situations are more common than the cancellations of 
end-use products or entire active ingredients, resulting from an EPA 
risk-management decision. In applying this policy, EPA would not 
distinguish between existing stocks dispositions made for a use 
deletion and a cancellation of an entire end-use product. If a 
modification request has been made for a pesticide that falls within 
one of the above categories, EPA intends in most cases to offer an

[[Page 16634]]

opportunity for public comment before making a final decision.
    EPA will also apply this policy regardless of the statutory 
mechanism EPA uses to extend the existing stocks period; thus, if EPA 
granted a section 18 emergency exemption, or allowed a state to issue a 
registration pursuant to section 24(c), to permit additional use of the 
existing stocks of a pesticide that falls within one of the above 
criteria, EPA would apply this policy. For example, if a state issued a 
section 24(c) registration for a voluntarily cancelled pesticide, that 
would effectively extend use beyond the existing stocks disposition, 
and the pesticide product fell within one of the categories discussed 
above, EPA intends to publish a notice of receipt in the Federal 
Register to solicit public comment, during EPA's 90-day review of the 
section 24(c) registration.
    EPA will not publish a notice before modifying the existing stocks 
provision for a pesticide that falls within one of the categories 
described above if EPA finds that an emergency exists. For purposes of 
this policy, an emergency is defined to exist only when EPA determines 
that the four following conditions occur: (1) Either the use of the 
pesticide is necessary to prevent an unacceptable risk to human health 
or the environment, or the continued use of the pesticide would present 
an unacceptable risk to human health or the environment; (2) there is 
not another feasible solution to prevent such a risk; (3) the time 
available to avert the risk is insufficient to permit the 30-day public 
comment period, and (4) the public interest requires modifying the 
provision in the manner described in EPA's proposal.
    An example of an emergency situation would be where EPA determined 
that it was necessary to reduce the existing stocks period to prevent 
an unreasonable risk, and that the risk would occur during the period 
necessary for notice and comment. In such a case, EPA would publish a 
notice after the emergency modification, explaining its action and the 
rationale for it.
    The statement of policy articulated here supplements, but does not 
replace EPA's 1991 existing stocks policy. Any decision to modify an 
existing stocks disposition would still be consistent with the general 
policies outlined in the 1991 notice. In some of the cases outlined in 
the policy, EPA regulations already require publication of a notice and 
solicitation of public comments, and the application of the policy 
announced today would result in minimal change to EPA practice. For 
example, if EPA were to receive a section 18 request that would 
effectively modify an existing stocks provision, EPA's regulations 
require EPA to publish a notice of the receipt of an application for 
the exemption and to solicit public comment in many cases to which this 
notice would apply. But in such circumstances, EPA would typically 
extend the comment period from the 15 days required by 40 CFR 166.24(c) 
to the 30 days specified in this policy. Nor would EPA waive the 
comment period except in the emergency circumstances outlined above.

IV. Comments

    The Agency is requesting comments and suggestions on the 
circumstances in which an opportunity for notice and comment would be 
provided. The Agency is also seeking comment on whether 30 days is an 
appropriate amount of time. Comments must bear a notation indicating 
the document control number [OPP-38512].
     A record has been established for this action under docket number 
``OPP-38512'' (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Rm. 1132 of the Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:

    [email protected]

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for the action as well as the public version, 
as described above will be kept in paper form. Accordingly, EPA will 
transfer all comments received electronically into printed, paper form 
as they are received and will place the paper copies in the official 
record which will also include all comments submitted directly in 
writing. The official rulemaking record is the paper record maintained 
at the address in ADDRESSES at the beginning of this document.

List of Subjects

    Environmental protection.

    Dated: April 10, 1996.
Daniel Barolo,
Director, Office of Pesticide Programs.
[FR Doc. 96-9353 Filed 4-11-96; 2:57 pm]
BILLING CODE 6560-50-F