United States December 1988
Environmental Protection Washington DC
Agency
Pesticides and Toxic Substances
Highlights
Of the 1988
Pesticide Law
The Federal
Insecticide,
Fungicide, and
Rodenticide Act
Amendments
Of 1988
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On October 25, 1988, the President signed into
law the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) Amendments of 1988.
The 1988 amendments to FIFRA, which is
administered by the Environmental Protection
Agency (EPA), strengthen the Agency's authority
in several major areas of pesticide regulation.
Among other things, the amendments require a
substantial acceleration of the reregistration
processor previously registered (licensed)
pesticides and authorize the collection of fees to
support reregistration activities. The law also
changes EPA's responsibilities and funding
requirements for the storage and disposal of
suspended and cancelled pesticides and the
indemnification of holders of remaining stocks of
such cancelled pesticides. Most provisions of the
1988 amendments are effective December 24, 1988.
Background on FIFRA
Under FIFRA, all pesticides must be registered
with EPA before they may be sold or distributed
in commerce. FIFRA sets an overall risk/benefit
standard for pesticide registration, requiring that
pesticides perform their intended function, when
used according to labeling directions, without
posing unreasonable risks of adverse effects on
human health or the environment. In making
pesticide registration decisions, EPA is required
by law to take into account the economic, social,
and environmental costs and benefits of pesticide
uses.
FIFRA was first enacted in 1947. Thousands of
pesticide products have been registered since
then. However, the standards for pesticide
registration have not remained the same since
1947, but have evolved in tandem with science
and public policy. In particular, test data
requirements for pesticides have become
increasingly stringent in light of advances in such
areas as toxicology and analytical chemistry.
Under FIFRA, pesticide registrants (companies
that hold pesticide registrations) are responsible
for providing all test data necessary to satisfy
EPA's registration requirements.
To ensure that previously registered pesticides
measure up to current scientific and regulatory
standards, FIFRA requires the review and
"reregistration" of all existing pesticides. This has
proved to be a massive undertaking. A
combination of factors has impeded the Agency's
progress in carrying out the reregistration
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mandate, including inadequate resources and the
sheer magnitude of the task. Of the approximately
600 pesticide active ingredients that require
reregistration under FIFRA, EPA has issued
"Registration Standards" for about 185. A,
Registration Standard includes a comprehensive
review of all th% avaii
reregister currently registered pesticides,
Reregistration will take place in five phases, as
follows:
• Phase 1: EPA is required to publish lists of
pesticide active ingredients subject to
reregistration and to ask registrants of pestkicfe
products containing those active ingrecnente
whether they intend to seek reregi's*rc?<&>,
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registrants seeking reregistration must aiso
identify missing and inadequate scientific studies
required to satisfy EPA's current data
requirements, formally agree to fill these "data
gaps" according to prescribed deadlines, and pay
the first portion of a reregistration fee. Phase 2
responses are required within three months after
EPA publishes each chemical list. If a registrant
de<;jd&s not to Seek reregistration, the registration
will b
• Phase 3: Registrants are required to s
and reformat key existing studies to facilitate EPA
review/ to certify that they possess OT have access
to "raw data" (such as laboratory records) from
studies, to "flag" any studies that indicate adverse
effects, to make a commitment either to generate
or to share the cost of generating new test data
where studies are missing or inadequate, and to
pay the final reregistration fee. Registrants are
required to accomplish these Phase 3
requirements within one and one-half to two
years after passage of the 1988 amendments.
Registrants must then fulfill remaining data
requirements within designated time periods.
* Phase 4: EPA is required to complete its review
of submissions made by registrants under Phases
2 and 3, to independently identify data gaps, and
to issue requirements for registrants to fill those
gaps. This will take place over a period of two to
four years after enactment of the 1988
amendments.
* Phase 5: This phase culminates the reregistration
process under FIFRA as amended in 1988, It
requires EPA to conduct a thorough,
comprehensive examination of all data submitted
in support of pesticide reregistration. Based on
this review, the Agency will either reregister a
pesticide or take other appropriate regulatory
action. This phase will occur over a span of
approximately three to nine years after enactment
of the 1988 amendments, depending on such
variables as the complexity of the studies required
for reregistration and the time required for
registrants to complete and for EPA to review
these studies.
Expedited Registration
The 1988 amendments also require EPA to give
expedited consideration to applications for initial
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or amended registration of products which are
similar to pesticides already registered with EPA,
"Similar" products include not only those which
are identical in composition to currently registered
products/ but also those which differ from
registered products only in ways that would not
significantly increase the risk to public health and
the environment. In addition, the Agency is
required to expedite certain minor amendments to
existing product registrations.
Under the expedited review provisions, an
applicant will be notified, within 45 days after the
Agency receives an application, \vhether the
application is complete. Within 90 days after the
Agency has received a fully complete application,
the registrant will be notified in writing whether
the request is granted or denied; if it is denied,
the specific reasons for denial will be given. A
portion of the fees collected by EPA will be made
available to the Agency for the purpose of
carrying out expedited processing of similar
applications and minor amendments to
registrations,
Fees
Reregistration is a complex regulatory process that
is expected to cost about $250 million over the
nine years of the 5-phase process. Approximately
$110-120 million of that cost is expected to come
from a continuation of the current level of EPA's
budget for reregistration activities, The remaining
funds will come from the pesticide industry
through two kinds of fees: a reregistration fee for
each active ingredient, and an annual fee for
registration maintenance to be paid for each
registered product.
For each active ingredient intended for use on
major food or animal feed crops, registrants will
be required to pay reregistration fees totalling
$150,000, In most cases, an initial payment of
$50,000 is due during Phase 2, and the balance in
Phase 3. For pesticide active ingredients not
intended for major food or feed uses, registrants
will be required to pay a fee of not more than
$150,000 and not less than $50,000. (The exact fee
depends on, among other things, whether a
Registration Standard has already been issued for
the pesticide and the extent of data required for
reregistration.) Active ingredient fees are to be
apportioned among registrants of each active
ingredient, based on market share.
Reregistration fee reductions or waivers will be
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granted for certain pesticide registrants. Any
antimicrobial active ingredient for which the
annual level of production does not exceed
1 million pounds is exempt; also exempt is any
active ingredient for which the value or volume of
use is considered minor. In addition, for any
"small business" registrant (any company with
150 or fewer employees and average annual
chemical sales of S40 million or less over the
three-year period prior to reregistration), the
reregistrarion fee will be based on a graduated
rate ranging from 0,5 to 1.5 percent of average
annual pesticide sales.
Unlike the reregistration fee, which is levied on
the basis of active ingredients, the annual
maintenance fee is assessed for each individual
pesticide product. For up to 50 product
registrations held by a registrant, the annual fee
has been tentatively calculated to be $425 per
product. For up to 200 products, the fee would be
$425 per product for the first 50 and SiOO for the
rest. However, there are maximum limits on the
total annual maintenance fees payable by any
registrant: the maximum possible total in
maintenance fees for any registrant for up to 50
product registrations is $20,000; and the absolute
maximum total in maintenance fees for any
registrant for any number of product registrations
is $35,000,
The objective of the maintenance fee program is
to generate approximately $14 million annually in
additional operating funds for the Agency. In the
event that there are not enough pesticide product
registrations to raise $14 million, EPA must
increase these annual maintenance fees. However,
regardless of any increase in per-product fees, the
maximum limits of $20,000 and $35,000 will
continue to apply.
During the nine-year period that these fee
provisions are in effect, the Agency is prohibited
from levying any other fee for the registration of a
pesticide. (The registration fees established by
regulation in May 1988 will be in abeyance during
this period.) However, the payment of fees for the
establishment of tolerances (maximum legal limits)
for pesticide residues in food or feed products,
required by the Federal Food, Drug, and Cosmetic
Act, is not affected by the 1988 amendments to
FIFRA.
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Storage and Disposal of Suspended or Cancelled
Pesticides
The 1988 amendments expand EPA's authority to
regulate the storage, transportation, and disposal
of pesticides. In addition to the authority to
require data on storage and disposal methods,
EPA is authorized to establish labeling
requirements for transportation, storage, and
disposal of the pesticide and its container. The
new law also enables EPA, for the first time, to
take direct enforcement action against violations
of storage, disposal, and transportation
requirements.
The 1988 amendments eliminate from FIFRA the
requirement that EPA, upon request, must accept
suspended and cancelled pesticides and dispose
of them at government expense. Under the new
law, EPA may require registrants and distributors
to recall suspended and cancelled pesticide
products. The Agency is authorized to require
registrants to give evidence of their financial
capacity to carry out such a recall. To facilitate any
recalls of this kind, EPA may require all persons
who sell, distribute, or commercially use
pesticides to notify EPA and state and local
officials of the quantities and locations of
suspended and cancelled pesticides in their
possession.
A registrant who wishes to become eligible for
reimbursement of storage costs incurred as a
result of a recall must submit a plan for storage
and disposal of the pesticide that meets criteria to
be established by EPA. Registrants will be
reimbursed for portions of their storage costs that
are attributable to delays in approval of storage
plans.
In order to lessen the problems associated with
pesticide container disposal, the amendments
require EPA to conduct a study of options to
encourage or require:
• The return, refill, and reuse of pesticide
containers.
• The development and use of pesticide
formulations that facilitate the removal of
pesticide residues from containers.
• The use of bulk storage facilities to reduce the
number of pesticide containers requiring disposal.
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The 1988 amendments also authorize EPA to
regulate procedures for storage, transport, and
disposal of containers, rinsates (such as water
used to clean a pesticide container), or other
materials used to contain or collect excess or
spilled pesticides. Additionally, in order to
promote the safe storage and disposal of
pesticides, EPA is directed to issue, within three
years, regulations for the design of pesticide
containers. These forthcoming regulations will
facilitate the safe use, disposal, and refill and
reuse of pesticide containers.
Indemnity Payments
Prior to the 1988 amendments, if EPA suspended
and cancelled the registration of a pesticide, the
Agency was required under FIFRA to indemnify
holders of the pesticide for losses suffered, up to
the cost of the pesticide. Moreover, FIFRA was
silent as to the source of funding for any
indemnification (or disposal) payments that might
occur. Persons previously covered by
indemnification included "end users" (such as
farmers and commercial pesticide applicators) as
well as pesticide formulators, pesticide dealers
and distributors, and registrants.
The 1988 amendments end automatic
entitlement to indemnity payments for all persons
other than certain end users, and provide that all
indemnity payments made will come from the
Judgment Fund of the Treasury, not from EPA's
operating budget. End users, such as farmers, will
continue to be eligible for indemnification through
the Judgment Fund.
Indemnification to anyone other than an end
user may be paid under the 1988 amendments,
only if Congress provides a line-item
appropriation. The 1988 amendments also require
all sellers of a pesticide (including registrants and
wholesalers) to reimburse the buyer for the
purchase price of a product whose registration is
suspended and cancelled, unless at the time of
purchase the seller told the buyer in writing that
the seller would not make such refunds. If EPA
determines that a business insolvency or
bankruptcy makes such reimbursements
impossible, dealers and/or distributors will also be
eligible for indemnification from the Judgment
Fund.
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Miscellaneous Provisions
The 1988 amendments also contain a number of
other provisions designed primarily to make it
easier for EPA to implement the major provisions
described above, including:
• Penalties: Criminal penalties are increased for
registrants, applicants for registration, or other
pesticide producers who knowingly violate the
pesticide law.
• Unlawful acts: The 1988 amendments provide
that certain acts, such as submitting false test
data, violating suspension or cancellation orders,
and failure to submit required records or allow
inspection, will be unlawful.
• Records and inspection: To help ensure
compliance with storage and disposal provisions,
additional authority is provided for EPA to
request records and to inspect places where
pesticides are being kept.
• Unregistered pesticides: The Agency is given new
authority to regulate unregistered pesticides.
• Scientific Advisory Panel (SAP): The 1988
amendments provide that the FIFRA SAP, a panel
of outside experts convened by EPA to review
major pesticide decisions or regulations, will be
permanent. Prior to the 1988 amendments, the
SAP required reauthorization every five years.
• Congressional review: The 1988 amendments
shorten the period of Congressional review of
final regulations from 60 days of continuous
Congressional session to 60 days.
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