OFFICE OF PESTICIDE PROGRAMS
ENVIRONMENTAL PROTECTION AGENCY
February 9, 1996
TABLE OF CONTENTS
I. Introduction
II. General Overview
III. How
to Submit a 24(c) Registration
IV. General Policies--Questions
and Answers
V. EPA Oversight
VI. Addendum for FIFRA
24(c) Registration
I. INTRODUCTION
As part of its streamlining and risk reduction
efforts, the Agency has evaluated the 24(c) registration process
and developed guidance and process improvements which will enable
the states and EPA to process 24(c) registrations faster with fewer
resources, and to promote EPA's goals of risk reduction and pollution
prevention. The policies contained in this guidance document are
effective immediately and are expected to result in significant
benefits for all concerned. A new internal standard operating procedure
is also being adopted to go along with the policies in this guidance
document and to streamline the processing of 24(c) registrations.
Under the authority of §24(c) of FIFRA, states
may register an additional use of a federally registered pesticide
product, or a new end use product to meet special local needs. EPA
reviews these registrations, and may disapprove the state registration
if, among other things, the use is not covered by necessary tolerances,
or the use has been previously denied, disapproved, suspended or
canceled by the Administrator, or voluntarily canceled subsequent
to a notice concerning health or environmental concerns.
In October 1991, EPA formed an internal work group,
the Center for Excellence for Special Local Needs [24(c)] Registrations,
to identify problems, propose solutions and to update policies and
procedures related to 24(c) registrations. The work group focused
on the procedures and issues which had proven to be problematic
in administering the §24(c) program. The goals of the work group
were to clarify the Agency's position on these issues, to streamline
the process and to provide guidance within EPA as well as to the
state lead agencies.
In July 1992, EPA held a workshop with states
and EPA regional representatives to collect and address a list of
24(c) issues of concern. The participants reviewed the list, prioritized
it and developed options for addressing the most significant issues.
EPA committed itself to resolving as many of these issues as possible,
to improving the 24(c) registration process and to providing clear
guidance to the states and regions.
This document culminates the efforts of the 24(c)
Center for Excellence to streamline the process, to empower the
states to reduce risks and to clarify EPA's position on important
policy issues. This guidance document is not intended to replace
the §24(c) regulations at 40 CFR part 162, rather to clarify the
regulations and to provide additional guidance. Specifically, this
document describes the states' and EPA's roles in the 24(c) registration
process, how states should submit notifications and EPA's position
on numerous issues. Finally, this guidance document is intended
to empower the states to operate as independently as possible to
reduce the resources EPA uses to review 24(c) applications and to
assure the public that no unreasonable adverse effects will occur
from 24(c) registrations.
Please note that this document is intended solely
as guidance and does not represent final agency action. It is not
intended, nor can it be relied upon, to create any rights enforceable
by any party in litigation with the United States. EPA officials
may decide to follow the guidance provided in this document, or
to act at variance with such guidance, based on analysis of specific
circumstances raised by a given 24(c) action.
II. GENERAL OVERVIEW
This section provides background information on
the states' and EPA's responsibilities under the law, how to submit
24(c) applications to EPA, and general policies.
A. STATES' RESPONSIBILITIES
States have been granted the authority by FIFRA
to issue special local needs registrations under certain conditions
while EPA is responsible for overseeing the general program. States
may register a new end use product for any use, or an additional
use of a federally registered pesticide product, if the following
conditions exist:
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Special Local Need. Special local
need means an existing or imminent pest problem within a state
for which the state lead agency, based upon satisfactory supporting
information, has determined that an appropriate federally registered
pesticide product is not sufficiently available. Refer to Section
IV (General Policies), Question 1, for the definition of Special
Local Need.
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The additional use is covered
by necessary tolerances or other clearances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
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Registration for the same use
has not previously been denied, disapproved, suspended, or canceled
by the Administrator, or voluntarily canceled by the registrant
subsequent to issuance of a notice of intent to cancel because
of health or environmental concerns about an ingredient contained
in the pesticide product. If new data becomes available that
resolves the Agency's health or environmental concerns, a 24(c)
may be submitted.
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Registration is in accord with
the purposes of FIFRA.
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If the proposed use or product
falls into one of the following categories, the state has determined
that it will not cause unreasonable adverse effects on man or
the environment:
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Use of a product which has a composition not similar to any federally
registered product.
Use of a product involving a use pattern not similar to any federally
registered use of the same product or a product of similar composition.
Use of a product for which other uses of the same product, or
uses of a product of similar composition, have had registration
denied, disapproved, suspended, or canceled by the Administrator.
In addition to these general conditions, states
must follow the specific procedures set forth in the regulations.
To assure that their 24(c) registrations are properly issued and
reported to EPA, states should also follow the guidance in this
document.
B. EPA'S RESPONSIBILITIES
EPA's role is to assure that each 24(c) registration
meets the requirements of FIFRA since these registrations become
federal registrations within 90 days unless EPA objects to them.
EPA reviews the individual 24(c) registrations and broadly oversees
the states' 24(c) registration programs.
EPA will limit its review of individual 24(c)
registrations to a minimal level which empowers states to meet the
requirements of FIFRA and which avoids any duplication of effort
by EPA. As described in the General Policies section, EPA will generally
not request data for amendments to federal products or new products
which are substantially similar to currently registered products
in composition and use. For 24(c) products which are not substantially
similar, EPA will ask for only a brief summary of the data, the
state's conclusions, and a certification that the product will not
cause unreasonable adverse effects as defined in FIFRA for registration
of pesticides. This approach will respect the states' independence
and responsibilities while allowing EPA to carry out its review
function with minimal resources.
EPA will also conduct general oversight by periodically reviewing
its records of 24(c) registrations to assure that states and EPA
have properly followed procedures and policies. If EPA finds problems,
it will discuss and resolve them with the appropriate state(s).
EPA will make every effort to work out problems with states, but
as a last resort EPA has the authority to rescind a state's authority
to issue 24(c) registrations if necessary.III. HOW
TO SUBMIT A NOTIFICATION OF 24(c) REGISTRATION
BASIC STEPS
1. The state should submit a complete 24(c) notification
package for each registration to the following address:
Document Processing Desk (SLN)
Office of Pesticide Programs - (7504C)
U.S. Environmental Protection Agency
401 M Street SW
Washington, D.C. 20460-0001
The 24(c) application notifies the Agency of a
state pesticide registration for a special local need issued under
the authority of FIFRA §24(c). The application also indicates the
date the state registration was issued. The state must notify the
Agency within 10 days of the date of issuance of the registration.
The Agency has90 days from the date the state registration
was issued to make a final decision on the 24(c) application. If
the state does not notify the Agency of the issuance of the registration
within10 days of its effective date, then the90 day
"clock" begins on the date that the agency receives the application
package [see 40 CFR 162.154(c)].
The application package should include the following items [see
40 CFR 162.153]:
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A properly completed Notification
of State Registration (EPA Form
8570-25).All requested information on the application
form should be provided.
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A cover letter with a description
of what special local need is being met by the issuance of the
24(c) and a clear explanation of how the definition of special
local need is met.
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A copy of the labeling approved
by the state.
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A properly completed copy of the
Confidential Statement of Formula (CSF) -Note:Only
required if the product isnot federally registered.
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An Unreasonable Adverse Effects Determination
Statement which summarizes the state's assessment of risks and benefits
which supports its conclusion that no unreasonable adverse effects
will occur.Note:An Unreasonable Adverse Effects Determinaton
Statement is only required if:
- The product isnot substantially similar in
composition and use pattern to a federally registered product.
or
- Other uses of the same product, or of a product
with a similar composition, have had registration denied, disapproved,
suspended, or canceled by the Administrator.
2. When received at the Agency, the application package
is processed by the Document Processing Desk and sent to the Front
End Processing Unit (FEPU) of the Information Services Branch (ISB).
The FEPU screens the application package to ensure that the previously
mentioned items are present (see 40 CFR 162.153). If any of the
items is not properly completed or is missing, the application package
is considered incomplete and is considered to be an improper notification.
The Head of the FEPU notifies the state, in writing, with a copy
to the registrant of record, of the deficiencies in the package
and that if proper notification is not provided, "the 24(c) registration
will be considered invalid as issued".
3. The state applicant is allowed14 days from
the date of issuance of the FEPU's notice to respond to the Agency
with a completed application package. If there are any questions
concerning the notification, the applicant may contact the head
of the FEPU at (703) 305-5264. The 90 day "clock" will begin upon
receipt of the resubmission.
4. If the state does not respond within 14 days,
the FEPU prepares a written response to the applicant, and a courtesy
copy to the registrant, stating that the Agency was not properly
notified of the state registration, and therefore, without the requested
information, "EPA considers this registration to have been invalid
as issued." The 24(c) registration will not be valid as of the date
EPA issues this letter. The Information Services Branch (ISB) Chief
signs the letter, which, with associated materials, is returned
to the state via certified mail.
5. If the application package is complete, the FEPU
enters pertinent information into an on-line tracking system. The
FEPU also publishes the 24(c) in the Federal Register (FR) Notice
summarizing all recent state registrations made under FIFRA § 24(c)
[see 40 CFR 162.153(i)] and sends the state an acknowledgement letter
concerning the receipt and completeness of the application package.
6. At this point, the application and any accompanying
data are forwarded to the Product Manager for review and determination
as to whether the 24(c) registration is acceptable (refer to the
Standard Operating Procedure for details). Any further communications
would come either from the Product Manager (PM) or higher level
officials as described in the SOP.
ADDITIONAL INFORMATION
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If the EPA Form 8570-25
indicates in block 2 (Product Is), that the cited EPA Registration
Number is a supplemental distributor registration, i.e., the
Reg. No. is a three part number such as XXX-XX-XXX, the PM notifies
the state that the 24(c) is invalid as issued. The 24(c) must
be issued based on the §3 registration of the product on which
the distributor registration is based (see issues 17 & 29).
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If data/studies are submitted
in support of a 24(c) application, the following applies:
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When fullstudies
are submitted in support of a 24(c) application, they
must comply with Pesticide Regulation Notice 86-5 format
(PR Notice). Studies that pass the PR Notice 86-5 screen
will be entered into the Agency maintained collection
of documents of regulatory significance called the Pesticide
Document Management System (PDMS); and archived onto
microfiche.
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Whendata are submitted
that do not constitute a formal study or are embedded
in correspondence, compliance with PR Notice 86-5 format
is not a requirement. The data will be retained in the
24(c) file and will not be added to the PDMS collection.
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Provided it is validly issued,
a 24(c) registration which is an amendment to a federally registered
product that has a use pattern similar to the registered product
may only be disapproved if that product: (a) has been previously
denied, disapproved, suspended or canceled by EPA because of
health or environmental concerns, or voluntarily canceled subsequent
to a notice of intent to cancel, (b) would cause an imminent
hazard (i.e., should be suspended), or (c) may result in food
residues not covered by tolerances.
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A 24(c) registration which is
a new product is either substantially similar to a federally
registered product or not similar. A 24(c) that is substantially
similar to an existing federal product has the same status as
an amendment. A 24(c) registration which is determined not to
be substantially similar to a federally registered product is
subject to additional requirements and is subject to disapproval
on reasonable grounds.
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If it is determined that a disapproval
is likely, the product manager (PM) will issue a Notice of Intent
to Disapprove the state Registration which will provide the
reasons for disapproval. This notice will generally require
the state to respond within 10 days of receipt of the notice
and will invite the state to consult with the appropriate Agency
designee [see 40 CFR 162.154(a)(2)]. The state applicant may
request, within 10 days of receipt of this notice, that the
PM Team consult with appropriate state officials prior to the
final decision on disapproval.
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If an application falls under
a general disapproval, disapproval must occur within a 90-day
review period and prior to disapproval, the state shall be notified,
in writing, of the Agency's intent to disapprove, and the reasons
for disapproval.
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If an application falls under
a special disapproval, that is, the registration would constitute
an imminent hazard or may result in a residue on food or feed
exceeding or not covered by a tolerance, exemption or clearance,
disapproval may occur at any time. The state does not need to
be notified prior to a special disapproval of the Agency's intent
to disapprove as required for general disapprovals. EPA will
notify the State as-soon-as practical of the special disapproval.
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If it is determined that labeling
changes are necessary, the PM will prepare and issue a letter
requesting that required labeling changes be made. The letter
will direct that one copy of the amended labeling be submitted
from the registrant,through the state, andto the
Agency.
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If the state applicant was issued
a Notice of Intent to Disapprove, and it is determined that
there are no longer reasons for disapproval, the PM team will
prepare a letter to the state notifying them of the Agency's
change in position.
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When a 24(c) is disapproved, the
Product Manager prepares and publishes a Federal Register Notice
which announces the disapproval of the 24(c) registration.
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Rescission of Previously Issued
Disapproval. In order to rescind a previously issued disapproval,
the PM Team must receive a submission from the state that issued
the 24(c) addressing previously noted deficiencies. Upon completion
of the review process, if it is determined that all previously
noted deficiencies have been resolved, the PM will prepare a
letter that rescinds the former disapproval. The letter addresses
resolution of deficiencies and informs the issuing state that
the disapproval is rescinded. The PM will publish a notice of
the rescission of disapproval in the Federal Register
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Request to Amend a 24(c) Registration.
In order to process an amendment, the PM Team must receive the
amended 24(c) registration from the state that issued the 24(c).
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Request to Withdraw a 24(c) Registration.
In order to process a withdrawal, the PM Team must receive a
request to withdraw the 24(c) registration from the state that
issued the 24(c).
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Request to Voluntarily Cancel
a 24(c) Registration. In order to process a voluntary cancellation,
the PM Team must receive a request from the registrant that
maintains the 24(c) registration. Also, the registrant should
send a copy of the voluntary cancellation request to the state
that issued that 24(c). A Federal Register Notice will be issued
which allows 90 days from date of publication for comment on
the request. A cancellation order listing the 24(c) registration
number will be prepared and signed. The cancellation order is
then sent to the registrant via certified mail and cancellation
information is posted to OPP data systems. A registrant can
choose to withdraw a request for voluntary cancellation during
the comment period by submitting a request in writting to the
Agency. If a third party is interested in the continuance of
the registration, they should contact the appropriate registrant.
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IV. GENERAL POLICIES:
QUESTIONS AND ANSWERS ABOUT §24(c) REGISTRATION
DEFINITION OF SPECIAL LOCAL NEED
1. Issue: What is the definition of "Special Local Need"?
Response: 40 CFR 162.151 states that special local
need (SLN) means an existing or imminent pest problem within a state
for which the state lead agency, based upon satisfactory supporting
information, has determined that an appropriate federally registered
pesticide product is not sufficiently available. EPA's current interpretation
of this definition of SLN is as follows:
a. "...existing or imminent pest problem..." means a problem which
already exists or is likely to exist.
b. "...based upon satisfactory information an appropriate federally
registered pesticide is not sufficiently available..." means a state
can document that a federally registered product a) is not available
in the state for the desired site(s) to adequately control the target
pest(s), or b) cannot be applied without causing unacceptable risks
to human health or the environment, or c) is necessary to maintain
an IPM, resistance management, or minor use pest control program,
or d) could be replaced by a formulation that poses less risk to
man or the environment.
States may consider uses such as the following
as candidates for special local needs: new method or timing of application,
new crop/new site, new pest, changed rate, application in particular
soil type, new product/different formulation, and products useful
in managing pesticide resistance in a particular crop.
States generally may not consider a price differential between
products as a candidate for a special local need.
When submitting a 24(c) notification to the Agency,
the state should include in the cover letter a description of what
special local need is being met by the issuance of the 24(c) and
a clear explanation of how the definition of special local need
is met.
2. Issue: Are there circumstances under which §24(c) registrations
should not be issued?
Response: Yes, a 24(c) registration should not
be issued under any circumstance that would trigger further data
requirements for a §3 registration to be issued. A 24(c) registration
must meet all the requirements of a §3 registration, and there must
be data to support the use. Expanding the use pattern of a §3 label
would be inappropriate if the added exposure would raise human or
environmental risk concerns. Situations such as the chemical is
under special review or the §3 label restricts the use to specific
geographic areas because of groundwater concerns, and the 24(c)
would expand the use in a manner that could contaminate groundwater,
a 24(c) should not be issued without consulting with the product
manager responsible for the chemical/use pattern. If the state can
demonstrate that the recommended 24(c) registration constitutes
no added exposure or risks, or that the exposure or risks are reduced,
a 24(c) may be appropriate. If a state has questions about a proposed
24(c), they should call the product manager responsible for the
chemical/use pattern.
EPA will make every effort to work with the states
on the 24(c) program, but if there is the need, the Administrator
may suspend a state's registration authority due to lack of, or
failure to exercise adequate control by the state over §24(c) program
as outlined in 40 CFR 162.155.
3. Issue: Can states issue §24(c) registrations which negate or
void voluntary or mandatory restrictions on §3 labels?
Response: §24(c) of FIFRA allows states to amend
federally registered products to meet specific local needs. Such
amendments may take the form of new uses or new use directions which
may differ from those on the §3 label. However, to the extent that
such provisions negate or void provisions of the §3 label in a manner
that could raise risk concerns, the use of 24(c) would be inappropriate
unless the state has data to demonstrate that the proposed change
will not cause unreasonable adverse effects to man or the environment.
4. Issue: Can states use §24(c) registrations to impose more restrictive
measures than are on §3 labels (e.g., reentry intervals, VOC programs,
etc.)? Can states issue §24(c) registrations which limit the use
of a §24(c) product to a subset of the uses on the §3 labels?
Response: Yes, under certain circumstances states
may impose more restrictive measures than are on §3 labels, or limit
use to a subset of uses on §3 labels. First, the state should determine
by contacting the EPA Product Manager whether the labeling changes
sought by the state may be accomplished by amendment to the §3 label
of the product. If a label amendment is not feasible, the state
would need to conclude that a special local need exists for a product
with specific restrictions which are not currently available in
that state and then proceed to issue a 24(c) registration. EPA encourages
states to communicate their needs to the Product Manager and to
work closely with the involved registrant(s) so that the most expeditious
solution to the problem may be obtained.
5. Issue: Can §24(c) be used to implement special programs such
as groundwater, endangered species, worker protection, etc. where
the label will refer to or contain detailed, localized restrictions
or use directions which are not on §3 labels?
Response: As stated in the response to issue 4,
states may issue §24(c) registrations to implement more restrictive
labeling under certain circumstances. If a state wishes to invoke
these circumstances for broad programs covering many products, it
may do so. However, EPA encourages the states to wait for EPA to
initiate such programs nationally on §3 labels. In this way, labeling
among products will be consistent and federally enforceable while
still permitting requirements unique to each state. For example,
EPA's groundwater program will involve a labeling statement which
requires compliance with a state management plan developed by each
state. Another example is EPA's endangered species program which
will involve a labeling statement referring to a county-specific
bulletin which describes where products may not be applied. While
states may choose to implement special programs sooner than EPA
and to use §24(c) registrations as the vehicle, they may do so at
a greater cost and may risk being inconsistent with EPA's programs.
6. Issue: Is offering growers a choice of products or a less hazardous
formulation (to humans, non-target organisms, or other environmental
component) an acceptable justification for a §24(c) registration?
Response: Yes. This would enable pollution prevention
and risk reduction as determined by the state. The state would need
to provide a clear explanation of the benefits and data to support
the special local need. States must review the data prior to issuing
the 24(c). This would include product chemistry data identifying
the amount of active and inert ingredients, making sure all ingredients
are cleared for food use by EPA, acute toxicity data on which the
toxicity category and precautionary labeling would be based, and
any additional data as needed such as residue, efficacy and environmental
fate. In the case of a new formulation, the state generally will
need to make a no unreasonable adverse effects finding.
7. Issue: Can states issue §24(c) registrations for the purpose
of avoiding buildup of pest resistance?
Response: Yes. The avoidance of pest resistance
can be described as a special local need if the state lead agency
possesses satisfactory supporting information to document the need.
Generally, such a finding can be supported only if the following
criteria are met:
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The pesticide registered under
the 24(c) must have a different mode of action from that already
available or if registering two pesticides under a 24(c), they
must have different modes of action.
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If there are currently registered
pesticides, there is only one effective mode of action remaining.
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The pest has a history of developing
resistance to existing or canceled pesticides which is documented
through field studies or references to field studies. Information
is needed on previously reported resistance incidences and economic
impacts resulting from pest resistance.
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The currently registered pesticide
has a history of resistance which is documented through field
studies or references to field studies.
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Evidence must exist that the pest(s),
use patterns, and climatic conditions for the proposed use under
the 24(c) is the same or substantially similar to situations
where resistance has been documented, i.e. similar pests, use
patterns, and climatic conditions.
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A brief description of the implementation
plan for resistance management and how the use under the 24(c)
will fit into the plan.
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8. Issue: When does a pest problem become regional or national
in scope so that it should no longer qualify for §24(c) registration?
How can states know whether a registrant is using §24(c) to avoid
federal registration?
Response: The term "special local need" does not
include situations such as interregional or nationwide pest problems.
The purpose of this exclusion is to prevent a registrant from seeking
special local needs registrations in many states rather than applying
for and obtaining a federal registration. States are strongly encouraged
to ensure that this does not occur. Generally speaking, If the same
§24(c) registration is issued in more than five (5) states, states
should start to question if the pest problem is a "special local
need" and not "interregional" or "national" in scope. If the same
§24(c) registration is issued in fifteen (15) states, generally,
further §24(c) registration will be denied and the Agency will contact
the registrant involved to discuss the situation. In situations
where a commodity is grown in a limited number of states, the Agency
may seek consultation with the registrant involved if a §24(c) registration
is issued by all most all the states growing the commodity. The
Agency realizes there are situations such as third party registration
for a widely used herbicide where a 24(c) registration may be needed
in multiple states based on local needs in each state. In this situation,
states should provide an explanation as to why the situation is
a "special local need".
Some resources the states can use to determine
what other states have already issued 24(c)s for particular situations
are CERIS (Center for Environmental & Regulatory Information
Systems), Pest Bank or the EPA Regional Office. CERIS' telephone
number is (317) 494-6614 or 494-6616.
ADMINISTRATIVE
9. Issue: May a state issue a §24(c) registration
for a use which has been voluntarily deleted from a federally registered
product or lost through voluntary cancellation of products?
Response: A state may issue a §24(c) registration
for a use which has been voluntarily deleted or canceled, but only
if the state or registrant submits any missing data required to
register or reregister that use. The Agency has already called in
reregistration data for most products. If a registrant decides not
to support certain uses, EPA publishes those uses in the Federal
Register to determine if anyone else wants to support them.
If no one wants to support them, they must be removed from the federal
label. If a state wants to issue a §24(c) registration for an unsupported
use, it must submit a letter, following the procedures given in
the FR notice, describing the data to be submitted, if required,
and providing a contact person. The state should contact the registrant
if it has questions concerning what missing data are required to
register or reregister a particular use. The Agency will then determine
whether the studies to be provided are likely to be adequate. If
so, the state will be advised to submit the studies with the §24(c)
application. When received, the studies will be reviewed by the
Agency and a determination will be made on the acceptability of
the §24(c) registration.
10. Issue: Should states set time limits for §24(c) registrations?
If so, how long should the limits be? Why does EPA not recognize
the states' expirations dates?
Response: The states are encouraged to set time
limits. However, since §24(c) registrations are deemed by FIFRA
to be §3 registrations after 90 days, EPA generally is not in a
position to impose time limits on §24(c) registrations. So long
as the §24(c) registrant complies with FIFRA requirements for maintaining
the registration (e.g., fee payment), EPA will not cancel the registration
even if the state has done so, unless the registrant voluntarily
cancels the product or EPA has a cause to issue a notice of intent
to cancel. Of course, the product may not be legally sold or distributed
in the state if the state has canceled the registration. The state
should encourage the registrant to cancel the 24(c) with EPA either
by filing a voluntary cancellation request or by not paying the
annual pesticide registration maintenance fee.
11. Issue: How does a registrant or state notify EPA in order to
voluntarily cancel a §24(c) registration?
Response: It is necessary for EPA to receive a
cancellation request from the registrant of record. It can be a
copy of a letter sent to the state or can be sent directly from
the registrant. Under present policies, the states cannot eliminate
§24(c) registrations from EPA's system without receiving authorization
from the registrant.
12. Issue: What is the status for use of a product in 90-day period
between state approval and EPA denial (if denied)?
Response: When the state issues the §24(c) registration
it is assumed to be valid and the product may be sold or distributed
and used after that time. If a disapproval is issued, sale and distribution
by the registrant or other persons would be in violation of §12(a)(1)(A)
beginning on the date of disapproval. However, use may continue
unless the disapproval notice states otherwise. EPA may rescind
the right for a state to issue a 24(c) registration if the state's
registrations are routinely denied or found unacceptable.
13. Issue: What is the status for use of a product when the state
receives a certified letter from EPA indicating the registration
is invalid as issued?
Response: Under EPA's new procedures, when an
application package is incomplete, the Agency considers this to
be an improper notification of state registration. The Head of FEPU
notifies the state, in writing, of the improper notification and
that if the proper notification is not provided, the §24(c) registration
will be considered invalid as issued. If the state does not respond
within 14 days, FEPU prepares a written response to the applicant
(cc:registrant) stating that the Agency was not properly notified
of the state registration, and therefore, without the requested
information, EPA considers this registration to have been invalid
as issued. The §24(c) registration is no longer valid.
14. Issue: Can a distributor request a §24(c) registration prior
to the §3 being registered?
Response: No, distributor registrations are based
on a federal registration and cannot differ from the basic registration
except that the product name and the company name and address may
be different than the basic manufacturers label or the distributor
label may contain a subset of the uses from the basic registration.
Until the basic registration has been accepted for other uses, the
distributor cannot know what the accepted label will be. In addition,
for the reason outlined above the basic registrant must request
a §24(c).
15. Issue: How should states review a §24(c) request on a product
which does not have federal registration?
Response: States may register new products only
in accordance with 40 CFR 162.152(b)(2). Where such new products
have a composition or use pattern different from a federally registered
product, or where use of a similar product has previously been denied,
disapproved, suspended, or canceled by EPA, the states must make
a determination prior to registration that the use of the product
will not result in unreasonable adverse effects on the environment.
The state must certify to and provide a rationale for this determination
in the notification of registration sent to EPA.
16. Issue: Can more than one §24(c) registration be issued for
the same use in the same state?
Response: Yes, however, the state should ensure
that additional §24(c) registrations are necessary to meet a state's
special local need and adequate data have been submitted to support
the use. Data submitted with the first §24(c) registration may satisfy
this requirement.
17. Issue: Can states issue §24(c) registrations citing a supplemental
distributor registration?
Response: A supplemental distributor product can
be used for a 24(c). The 24(c) is issued on the §3 registration
on which the distributor registration is based. The distributor
product is the same as the §3 registration and is incorporated under
the §3 registration. The 24(c) should be issued on the §3 registration
even if the distributor product is the only product available in
that state. A separate 24(c) registration is not needed for the
distributor product. With the approval of the basic registrant,
the distributor may produce a 24(c) label based on the basic registrant's
label.
18. Issue: Can a state issue a §24(c) registration citing more
than one §3 registration?
Response: No, each §24(c) registration must cite only one §3 registration.
ENFORCEMENT
19. Issue: What should states do when they obtain information that
other registrants are possibly misusing the §24(c) registration
process?
Response: For clear enforcement issues, states
should make referrals to the Regional enforcement office. If it
is more of a policy issue question, state officials should call
the §24(c) Coordinator through the Registration Division main office
(currently 703-305-5447).
20. Issue: What should be done with old, expired §24(c) registrations?
Some products were only used with §24(c) product labeling, their
§3 usages being made obsolete by other better products.
Response: A state may choose to provide a period
of use for existing stocks or may choose to prohibit the use of
existing stock. However, the product would continue to be registered
with EPA unless the fees were not paid or other appropriate action
under §6 occurred. If EPA cancels or suspends the product, use will
be permitted, if at all, in accordance with any existing stocks
order issued by the Agency.
21. Issue: Can a product be used up according to the §24(c) product
label as long as it is in the possession of the user?
Response: Yes, unless either the state, if it
has such authority, or EPA has prohibited the use of the product
as part of a cancellation order. To date this has been a rare occurrence.
22. Issue: What should states do when they discover that a §24(c)
registration issued in one state is being used in another state?
Response: It is a misuse to use a §24(c) product
in a state if it is not registered in that state. The state should
inform the EPA Regional Office of enforcement and followup with
appropriate enforcement action.
DATA REQUIREMENTS
23. Issue: What are EPA's guidelines relative to the age of residue
data (applicability of older methods when recovery data are included)?
Response: There is no specific date before which
residue data were generated that leads to automatic rejection of
that data. Provided the analytical method has been properly validated
(control, spiked, and treated samples) and measures the total residue
of concern as expressed in present tolerances, and is otherwise
consistent with current Agency requirements that residue data would
be considered valid.
24. Issue: How restrictive should states be relative to accepting
residue data and their conformity to GLP (# of replications, dosage
rate relative to label rate, etc.)? Is non-GLP data acceptable for
a §24(c) registration?
Response: Although any new data should follow
GLP, non-GLP data are not automatically rejected. The data submitter
should point out why the data do not meet GLP and submit a rationale
as to why the departure does not invalidate the data. The key factors
that EPA looks for in residue data are (1) evidence that the pesticide
was applied according to label directions resulting in highest residues
(maximum application rate, maximum number of applications, shortest
interval between applications and shortest preharvest interval)
and (2) recovery data showing the analytical method was capable
of measuring the total residue of concern. Any studies not meeting
these two requirements are likely to lead to rejection of the §24(c)
registration.
25. Issue: What data does EPA require to be submitted to EPA with
a §24(c) registration? Residue and efficacy data have been the primary
supporting data for most §24(c) registrations in the past. However,
EPA has been turning down or requiring revisions of §24(c) registrations
due to environmental and toxicological concerns. If this type of
data is required with a §24(c) registration, states need to know.
Response: No data should be submitted to EPA unless
it is requested or the state is unable to review it. If a state
is issuing a §24(c) registration for a new product that meets any
of the criteria in §162.153(c), the state is required to ensure
that there are no unreasonable adverse effects. If the state is
unable to make this determination, it should submit the data to
the Agency with the §24(c) notification and EPA will review it and
make the determination.
26. Issue: If a tolerance for a crop was issued many years ago
and EPA no longer considers the residue data adequate, can states
issue a §24(c) registration to add the new use covered by the tolerance?
Would additional residue data be required?
Response: The state can issue a §24(c) registration
as long as there is a tolerance in place. There is a possibility
that the Agency may request additional residue data during review.
In the circumstance where a regional tolerance exists. the state
should contact the product manager to find out what additional data
may be needed to allow consideration of a SLN.
27. Issue: What type of information does EPA need to keep a SLN
for seed use non-food. If EPA has a legitimate concern about carryover
to subsequent crop what kind of residue information is needed?
Response: The term "seed use" could be interpreted
to mean direct application of a pesticide to seeds before planting
(seed treatments) or application in the field to crops grown for
seed. We will discuss these separately.
With regard to seed treatments the use can be considered
non-food only if a radiotracer study shows no uptake of radioactivity
into the aerial portion of the crop (or into the underground portion
of root crops). Our experience with such studies is that it is quite
unlikely a seed treatment will be considered a non-food use. In
most cases a tolerance is established at the detection or quantitation
limit of the analytical method on the crop grown from the treated
seeds.
Applications to crops grown for seed
can be considered non-food uses if the following two conditions
are met:
(1) Subsequent to treatment no parts of the crop will be diverted
to use as human food or livestock feed.
(2) There is no likelihood of residues in crops grown from the
harvested seed.
Each of these two conditions is discussed in more detail below.
In some instances the first condition may be met by the timing
of the application. In other words, the condition is met if the
pesticide is applied to the seed crop at a point when it is no longer
fit for consumption. An example would be use of a desiccant on carrots
or radishes near the time of seed harvest. At this time the roots
would no longer be desirable as a food.
In those cases where the application timing does not satisfy the
first condition, there are two other possible means of meeting that
condition:
(A) The state in which the registration is sought
provides assurance through some regulatory process that the seed
crop will not be diverted to food or feed. This assurance must
include all crop parts that could be consumed by humans or livestock.
Crops of special concern are alfalfa, clover, and grass, which
may be cut for hay or whose seed screenings may end up as animal
feed. The first example of a state using this procedure was Washington
for registration of pesticides on alfalfa grown for seed.
(B) Cultural practices information is submitted showing
how the seed crop may be distinguished from the corresponding
food crop and how the seed crop is not commercially viable as
a food crop. Examples of such cultural practices might be smaller
crop spacing preventing adequate root formation or planting in
a different season to encourage bolting versus head formation.
Some general statements can be made at a crop grouping level with
regard to the chances of the first condition being met. Most cole
crops, leafy vegetables, and root crops grown for seed have a good
chance of meeting this requirement. On the other hand, crops where
the seeds themselves are major raw agricultural commodities such
as grains, beans, and peas have very little chance of non-food registrations.
Cucurbits and fruiting vegetables are probably not eligible for
non-food uses since the fruit is still edible at the stage when
the seeds have formed.
Now we will address the second condition to be met for a non-food
use: "There is no likelihood of residues in crops grown from the
harvested seed." In many cases this condition may be met without
actual residue data on the harvested seed or the crop grown from
that seed. The registrant and/or state should consider data or information
on the following factors when calculating a theoretical residue
in the crop grown from the harvested seeds.
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Weight of seed
|
- |
Weight of edible portion of following
crop
|
- |
Total weight of following crop
|
(The above weights could be expressed in terms of an individual
seed/plant or on a per acre basis. In either case the figures
would allow an estimate of the dilution of residues due to growth
of the plant.)
- |
Tolerances on other crops with
similar rate and preharvest interval
|
- |
Information as to whether the
seeds are directly exposed to the pesticide spray
|
(The above two factors can be used to estimate maximum likely
residues on the harvested seeds.)
- |
Seed treatment data for the pesticide
on other crops
|
- |
Degree to which the pesticide
translocates (how systemic?)
|
- |
Half-life of the pesticide on
other crops
|
(The above three factors can be used to estimate how much pesticide
might move from seed to the growing crop.)
If a calculation using reasonable assumptions and taking into account
the above factors indicates residues in the raw agricultural commodity
grown from the harvested seeds will be well below (for example,
one order of magnitude) the detection limit of the analytical method,
then condition two would be met. On the other hand, if the calculation
shows residues close to or above the detection limit, actual residue
data on the harvested seeds and/or following crop will be required
to show that the use can be considered non-food.
THIRD PARTY REGISTRANTS
28. Issue: Can EPA help the states develop a standard and effective
liability disclaimer for third party registrants?
Response: While EPA might assist the states in developing acceptable
disclaimer language for third party §24(c) registrations, whether
such disclaimers would be effective in court is a matter of individual
state tort law, and is therefore, beyond the control of EPA.
29. Issue: How will the agency address third party applications
that do not have the support of the basic producer?
Response: The Agency expects the state to make every effort to
ensure that the 24(c) issuance is agreed to by the registrant. The
Agency believes that FIFRA and EPA regulations do not prevent the
state from issuing a registration to a third party applicant even
if the registration does not have the support of the basic registrant.
In such instances, the third party registrant would actually become
the registrant and would be responsible for maintenance fees, any
data to support the 24(c) product, the addition of required label
language for worker protection standard, endangered species etc,
and all other obligations of a registrant under FIFRA.
COMMUNICATION
30. Issue: How can a state find out what EPA's response to a §24(c)
registration would be prior to actually submitting the registration?
Response: The state should contact the appropriate Product Manager
with specifics on the proposed 24(c) registration. If the state
does not know who the appropriate Product Manager is, the state
should contact the appropriate Branch Chief in the Registration
Division who can indicate which PM to contact.
31. Issue: Could states be given a list of product managers by
active ingredient? States need a list of people they can call on
for a given registration to ask about special requests [i.e., residue
data requirements on seed crops, environmental fate questions, residue
data comprehensiveness questions, labeling format, precautionary
statements on a §24(c) registration].
Response: The current PM/a.i. list is over one hundred pages long
and is being updated. It changes frequently due to new active ingredients
and switches between PM. It is our hope that the recently established
Information Management Strategy Group (which includes the states)
will be able to make available an electronic list in the near future.
We have included in this document a one-page summary listing the
Product Managers and the types of products they manage.
32. Issue: Should EPA make available a listing of issued §24(c)
registrations to all states? If so, what method would be preferable?
Response: The states should seek this information through the Information
Management Strategy Group. Questions may be directed to Branch Chief,
Systems Branch at 703-305-5484.
33. Issue: How can states find out if EPA canceled the special
local need; for instance, for failure to pay maintenance fees?
Response: The states should seek this information through the Information
Management Strategy Group. Questions my be directed to Branch Chief,
Systems Branch at 703-305-5484.
34. Issue: Whom should states call with questions about interpretations
of §24(c) regulations?
Response: Specific questions about a specific §24(c) registration
may be directed to the Product Manager. General questions may be
referred to the §24(c) Coordinator at 703-305-6250.
FEES
35. Issue: Can §24(c) registrations can be exempted from maintenance
fees?
Response: Maintenance fees can be reduced or waived for minor agricultural
uses when the Agency determines that the fee would be likely to
cause significant impact on the availability of the pesticide. If
a state believes a use qualifies, it may contact the maintenance
fee information line at 1-800-444-7255 for specific instructions.
V. PROPOSED MONITORING OF THE 24(c)
PROGRAM
To ensure the 24(c) program is being implemented
in accordance with these requirements, as well as best utilize resources,
we plan to put into place a program to monitor the 24(c)s.
The objectives of the monitoring program will be to:
1) Evaluate the states performance in exercising control over
their registrations and,
2) Evaluate the performance of OPP in overseeing the 24(c) program.
3) Monitor for the possible circumvention of §3 registration
through the use of 24(c)s.
EPA plans to monitor the performance of the 24(c)
program by reviewing a small selected sampling of previous 24(c)
reviews and decisions. EPA will monitor for unreasonable adverse
effects problems, tolerance problems, patterns in rejection rates,
and consistency in reviews. EPA will monitor the number of 24(c)
registrations being issued for individual products and use sites
to monitor compliance with the provisions outlined in issue 8.
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