Office of Pesticides
•nd Toxic Substsnces
Wwhington DC 204t>0 February 1990
Office of Pesticide Programs
oEPA Environmental
Fact Sheet
PESTICIDE REREGISTRATION
INTRODUCTION
The Environmental Protection Agency (EPA) is required by law
to reregister existing pesticides that were originally registered
years ago when the standards for approval and the test data
requirements were much,less stringent .than they are today. This
comprehensive reevaluation of pesticide safety in light of modern
standards is critical to protecting human health and the
environment, and to maintaining public confidence in our food
supply. There are approximately 600 pesticide active ingredient
cases requiring reevaluation. Reregistration of these chemicals
has proved to be a massive undertaking and has proceeded slowly,
both because of inadequate resources and the sheer magnitude of the
task.
In 1988, The Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) was amended to strengthen EPA's pesticide regulatory
authority and responsibilities regarding the reregistration of
pesticides. These amendments mandate an accelerated reregistration
scheme, to be carried out in five phases concluding in 1997. The
new law (known as FIFRA '88) imposes explicit duties and strict
deadlines on EPA and pesticide registrants alike. The thrust of
the phased approach is to generate a complete scientific data base
for each pesticide product before evaluation by the Agency and
reregistration of products. Under FIFRA, pesticide registrants
have always h«en responsible for making data available to EPA.
The amendments also require, for the first time, that
registrants bear a significant portion of the cost of
reregistration by paying reregistration fees. The estimated cost
of accelerated reregistration is about $250 million. These and the
other provisions of FIFRA '88 are described in detail in Attachment
I — EPA's plan for implementing the amendments.
THE REGISTRATION STANDARDS PROGRAM
The Agency began a systematic reevaluation of existing
pesticides in 1980 through a process called the Registration
Standards program. A Registration Standard describes the Agency's
evaluation of the available data on an existing chemical,
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identifies and requires submission of additional data, and sets
forth other conditions a registrant must meet in order for EPA to
reregister pesticide products containing the active ingredient.
These other conditions typically include modifications to
registrations, labeling, and tolerances as necessary. In some
cases, Registration Standard review also results in restricting the
use of a pesticide or beginning a Special Review to deal with any
unreasonable risks. Registrants who do not comply with a
Standard's requirements are subject to suspension or cancellation
actions.
When EPA established the Registration Standards program, it
set priorities for conduting reviews giving priority to chemicals
with the highest potential for exposure — high-volume and food-
use chemicals. By December 1988, EPA had issued 194 Registration
Standards, roughly 25 per year. Because chemically-related active
ingredients have been grouped into Registration Standard "cases",
these 194 Standards actually represent 350 individual active
ingredients. Because of the priorities established for
reregistration, the 194 Standards issued account for 85 to 90
percent of the total volume of pesticides used in the United
States.
Once EPA receives the data required by a Registration
Standard, the Agency must thoroughly review those data and the
pesticide's uses and decide whether to reregister the active
ingredient and products containing it. This review of data is
called a second round review.
The Registration Standards for most of the chemicals
considered to be ready for second round review were issued in the
early 1980*s. Since that time EPA*s data requirements for
registration and testing guidelines have been revised and expanded.
Consequently, as EPA completed these second round reviews it has
levied yet additional data requirements, thus further postponing
reregistration decisions.
ACCELERATED REREGISTRATION
In recent years 't became increasingly apparent that under
the Registration Stan vds program EPA would not have been able to
complete reregistration of existing pesticides as quickly as
Congress originally envisioned. At the pace of issuing 25
Registration Standards per year, reregistration could not have been
completed until well beyond the year 2000. As a result of growing
public concern about how long it would take to reassess existing
pesticides, particularly those used to produce our food supply,
Congress acted in 1988 to substantially change EPA's approach to
the problem. The FIFRA "88 amendments were signed into law by the
President on October 25, 1988, and became effective on December 24,
1988.
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The reregistration provisions of FIFRA '88 establish mandatory
timeframes and duties, applicable to both EPA and pesticide
registrants, for reregistration of pesticides. The law now
requires EPA to complete, over approximately a 9-year period, the
reregistration review of each registered product containing any
active ingredient registered before November 1, 1984. (EPA's most
recent version of data requirements for registration were published
in November 1984; Congress was aware that most pesticides
registered after then would have up-to-date data bases.) Congress
directed EPA to carry out reregistration in five phases (see
Attachment II). These phases establish deadlines for pesticide
registrants to identify and supply the test data necessary for EPA
to make pesticide reregistration decisions, as well as for EPA to
analyze submissions and to determine whether to reregister
currently registered pesticides. Summaries of each of the five
phases, and what EPA has done on them to date, are described below.
Phase It Phase 1 requires EPA to publish lists of pesticide
active ingredients subject to reregistration and to ask registrants
of pesticide products containing those ingredients whether they
intend to seek reregistration. These lists must be published
within 10 months after the effective date of the amendments.
EPA has completed this phase of accelerated reregistration by
publishing the following four lists of pesticides subject to
reregistration. List A, by law, contains the 194 pesticide active
ingredient cases (350 individual active ingredients) for which
Registration Standards were issued prior to December 24, 1988.
Lists B, C, and D, were also developed by grouping chemically-
related pesticide chemicals. For the purposes of inclusion on
those lists, EPA was directed by Congress to prioritize chemicals
by applying the following criteria (again focusing on chemicals
with the highest potential for exposure) : use on food or feed,
whether there are residues of concern in drinking water, edible
fish or shellfish; significant outstanding data requirements prior
'it should be noted that *:he chemicals contained on List A
are not subject to the phase ata submission provisions of the
FIFRAx88 accelerated reregistration scheme (phases 2,3, and 4),
although the List A chemicals a subject to the fee provisions.
Congress did not set a phased data submission schedule for List A
chemicals because a large part of the work required of registrants
for reregistration under FIFRA '88 had already been done in the
Registration Standards program. Instead, EPA conducted an
inventory of active ingredients of List A to determine whether the
data submitted in response to Registration Standard review are
sufficient to conduct a thorough evaluation and make a
reregistration decision, or whether additional data are needed.
This inventory and the results are discussed in more detail
following the description of the phased approach to accelerated
reregistration.
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to December 24, 1988; and worker exposure. In addition, the Agency
identified additional listing criteria including: Special Review
status; restricted use pesticides; effects on non-target or
endangered species; and dioxin/furan contamination problems.
List A was published in the Federal Register on Feburary 22
1989. List B was published in April 1989; Lists C and D were
published at 3-month intervals after that date.
Phas« 2; Phase 2 requires registrants to declare (within 3
months after publication of each chemical list) whether they intend
to seek reregistration by identifying applicable data requirements
and missing studies, by committing to submit new studies or replace
inadequate existing data, and by paying the first installment of
the reregistration fee. If a registrant does not seek
reregistration EPA will cancel the registration.
EPA is now examining the results of the Phase 2 responses for
Lists B and C chemicals. The Agency received about 3,000 responses
and, in general, registrants have responded well to a new, very
complex process. The results to date show that a relatively high
number of chemicals are not being supported by the basic
registrants — 99 in 40 cases in List B and about 190 in 72 cases
in List C. Also, there appears to be a fairly low number of
requests to delete registered uses of chemicals.
Phase 3; Phase 3 adds to the responsibilities of registrants
who decide to comply with phase 2. During the nine months after
the Phase 2 deadlines registrants will be required to resubmit
existing studies that have been refo:.*matted and summarized
according to Agency guidance, to certify the availability of raw
data, to "flag" studies that indicate adverse effects, to make
additional commitments to satisfy all applicable data requirements,
and to pay the final installment of the registration fee.
Registrants who fail to comply may be subject to cancellation
actions.
- EPA is required to issue guideline to assist registrants in
summarizing and reformatting studies, i. .dentifying studies which
may be inadequate but still may be considered, and in "flagging"
adverse effects data. EPA issued these guidelines on December 22,
1989. In addition, the Agency will monitor the progress of
registrants in filling data requirements.
Phase 4: This phase requires that EPA review all Phase 2 and
3 submissions and to determine independent1 y whether all applicable
data requirements have actually been satisfied, and if not, require
registrants to fill any newly developed data requirements. It also
requires the Agency to notify the registrants when a data base is
complete. These activities will take place over a period of 1-3
years aftger enactment of FIFRA '88. At the same time, EPA expects
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to work on reregistration reviews for List A chemicals as discussed
below.
It should be noted here that each tine a registrant commits
to submit data in Phase 2 or 3, or when EPA requires data in Phase
4, those data must be submitted according to schedules established
by EPA, but no later than 4 years after the date of a registrants
commitment. In the past, EPA has beeen flexible in extending
deadlines for submitting required data. However, FIFRA '88 gives
EPA much less discretion in this area. Time extensions may be
granted only if there are "extraordinary circumstances" beyond the
registrant's control.
Phase 5: Phase 5 requires the Agency to conduct comprehensive
assessments of all data submissions and decide whether products
containing the active ingredients in question may be reregistered
(and if so, under what conditions), decide whether product-specific
data are needed, and reregister products of take other appropriate
regulatory action. This phase will occur over a span of roughly
3-9 years after enactment of FIFRA '88, depending on the scheduling
of individual chemicals, the complexity of the required studies,
and the time required to complete these tasks.
Once EPA has found an active ingredient to be eligible for
reregistration, the Agency must evaluate the end-use products
containing that active ingredient, based on product-specific data.
Accelerated reregistration provisions of FIFRA '88 allow for 8
months for generation of product-specific data (unless EPA decides
that more time is needed) . Upon receipt of those data, EPA is
required to review them within 90 days and to reregister products
of take other appropriate action within 6 months.
REREGISTRATION OF LIST A CHEMICALS
The Registration Standards program described above had as its
objective the reregistration of registered active ingredients.
However, the review of a chemical in this process generally
revealed ••*. t substantial additional data were -->quired before a
reregistre,.^on decision could be made. As past the preliminary
analyses for implementing the FIFRA '88 reregistration
requirements, the Agency reviewed each of these Registration
Standards to create an up-to-date inventory of the current status
of each of these chemical cases.
List A Inventory
Objective — In order to manage and prepare a plan for the
reregistration of the high exposure, and thus high priority, List
A chemicals, EPA conducted an inventory of the data requirements
and studies submitted in response to each Registration Standard.
The objective of this project was to identify action needed to
expedite the reregistration of each List A chemical. Through this
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process EPA identified chemicals with data bases complete enough
to permit a thorough evaluation and reregistration decision, and
chemicals for which additional data would be needed before a
reregistration decision could be made.
For those chemicals which essentially complete data bases, the
Agency will schedule a reregistration eligibility review. For
active ingredients with less complete data bases, EPA will issue
data call-in notices to promptly require the additional data needed
to evaluate the active ingredients and conduct reregistration
reviews when all key data are received. If EPA makes a decision
to reregister the active ingredient, the Agency will require
product-specific data to be submitted„
Inventory process — The inventory process consisted of
reviewing the data requirements levied in the Registration
Standards by scientific discipline and determining the following:
— whether the data requirements for currently registered
uses meet contemporary scientific standards
— whether a reevaluation of the acceptability of studies
previously submitted and reviewed is necessary
— whether new data requirements are necessary
The Agency also collected status information for each chemical to
show:
— the number and type of studies required by
discipline in the Registration Standard
— the number and type of studies received in response
to the Registration Standard by discipline and date
of receipt of the study
~ the number of new requirements, by discipline
~ the number eurtd type of studies reviewed, review
date, and whether the study was accepted, by
discipline
Inventory Results
Based on the information collected, the Agency assigned one
of the following classifications for each chemical.
— Reregistration Review - Data requirements levied
were appropriate and chemical is ready for rere-
gistration decision; or data requirements
appropriate and will be ready for reregistration
decision when data are submitted
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— Data Call-in - Inventory review concluded that
data are needed and will be required under FIFRA
section 2 (c)(2)(B) prior to reregistration review
— Follow-up and In-depth Review - Administrative
follow-up or review of data already submitted is
needed prior to determining if a data call-in notice
should be sent to the registrant or if the chemical
is ready for a reregistration review
The result of the inventory project is shown in the Table
below:
LIST A INVENTORY RESULTS
Decision No. of Chemical Cases
No longer subject to reregistration 28
(All products suspended or cancelled)
In Reregistration Queue 65
(All data in) (11)
(Awaiting data) (54)
Data Call-in 50
Follow-up and In-depth Review 51
(Follow-up) (30)
(In-depth Review) (21)
During the remainder of this fiscal year, the Agency will
conduct Phase 5 reregistrat*'«-»n review for the 11 cases which are
ready for it. EPA will also TJ induct the required data call-in for
the 50 cases requiring it and complete the in-depth review and.
follow-up for all of the remaining chemicals. EPA will establish
schedules for review of all chemicals in accordance with the
projected receipt dates for the required studies.
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ATTACHMENT I
Wednesday
April 26, 1989
Part II
Environmental
Protection Agency
Federal Insecticide, Fungicide, and
Rodenticlde Act Amendments of 1988;
Schedule of Implementation; Notice
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U078
Federal Renter / Vol. 54. No. 79 / Wednesday. April 28. 1989 / Notice*
ENVIRONMENTAL PROTECTION
AGENCY
Act AflMfKWMniB Off
Agency (EPA or Agency).
Acnesc Notice.
rs OB October 25.1888, tfat
{Resident signed into law the Federal
fasectJtide. Fungidde, and Rodeatidde
Act (FIFRA) Amendment* of 1988
(FIFRA "88). This notice summarizes the
provision* of FIFRA '88 and sets forth
EPA's general plan and tchedule for
implementing them. EPA invite*
comment* on it* general approach for
implementation.
BATES: Comment* on thi* notice mu*t be
submitted by July 25,1988.
aaomtr Comment* on thi* notice
should reference the document control
number "OPP-34000" and be mailed to:
Public Docket and Freedom of
Information Section. Field Operation*
Diviiion [H7506C], Office of Peiticide
Program*. Environmental Protection
Agency. 401 M Su SW, Washington. DC
20460.
In person, bring comment* to: Rm. 248.
CM #2.1921 lefferaon Davi* Highway,
Arlington, VA.
FOM PUKTHU INTOHMATIOM COMTACR
By mail Deborah J. Si*co. FIFRA '88
Task Force (H7501Q, Office of Pe*tidde
Program*. Environmental Protection
Agency. 401M SL, SW, Washington. DC
20460. Office location and telephone
number Rm. 1101, CM *! 1921 Jefferson
Davi* Highway. Arlington. VA.
Telephone (703) 557-7372.
I Background
A. Regulation of Pesticides Under
FIFRA
Under FIFRA. pestiddet mast be
registered (licensed by EPA before they
may be sold or distributed la commerce
m the United States. Pestiddes include
msectiddes. herbicides, fungicide*.
rodentiddes, disinfectants, plant growth
regulators, and other substance*
intended to control pests.
Approximately 35,000 to 40400 pesticide
products arc currently registered la the
United States. FIFRA require* that
pesticides used according to labeling
directions perform their intended
functions without causing unreasonable
adverse effects on people or the
environment In assessing the potential
to cause unreasonable risks for pestidde
registration decisions. EPA is required
by law to take into account the
economic, sodaL and environmental
casts and benefits of pestidde uses.
FffRA was first enacted in 1947.
Thousands of pestidde products have
since been registered. However.
Geagnss has amended FIFRA several
tirae* sine* 1947, and the standard* for
pcstidde registration have evolved to
taadem with advances in sdence and
public policy. In particular, teat data
nqearemeaU for pestiddes have
became increasingly more stringent to
light of advances in such areas as
toxicology and analytical chemistry.
Under FIFRA. the registrant or
applicant for registration has the
responsibility for demonstrating that a
pestidde meet* aQ the criteria far
registration. The Agency bases
registration decision* for new pestidde*
on its evaluation of test data provided
primarily by applicants for registration
(usually the companies that produce the
pestidde products). Required studies
include testing to show whether a
pestidde has the potential to cause
advene effect* in humans and wildlife,
including endangered spedes. Potential
humaa effects indude acute reactions
such as toxic poisoning and skin and
eye irritation, as well as other affect*
such a* cancer, birth defects, or
reproductive system disorders. In
addition. EPA must have data to
estimate exposure to pestiddes, such as
data on residues in food and potential
worker exposure. Data on
environmental fate, or how a pestidde
behaves in the environment an also
required so that EPA can determine,
among other things, whether a pestidde
poset a threat to ground or sanscc
water. Testing to acquire such data most
be conducted in accordance with Good
Laboratory Practice Regulations and
nay be subject to audit by the Agency.
te addition to registering new
pesticides, EPA is charged with
protecting human health TivH *t»*
•Bvironment from any unreasonable
adverse effect! associated win
pestiddes already registered and m oae.
FIFRA enthorizes EPA to cancel the
registration of an •**«*"g peatidd* If
data show mat it causes unreasonable
adverse effects on human health or the
environment The cancellation process
can take 2 years or more to ccmplet*.
Under certain circumstances, EPA may
take action to suspend the registration
af a pestidde to prevent aa «•«•«««••*
hazard during the cancellation review.
Until the 1968 amendment*, EPA waa
required under FIFRA to accept
pesticides suspended and cancelled due
to their potential for imminent hazard
for disposal at government expense, m
addition, an indemnification provision
required EPA to reimburse holders of
such suspended and cancelled
pestiddes for fiaaada! losses suffered.
•p to the fair market value of the
pestidde.
To ensure that previously registered
paatiddea meet current adeatific
standards. FIFRA requires that
pestiddes originally registered a number
of yean ago be "reregistered" under
current sdeotific standards. This is a
massive -««<*^«-H"t la the interest of
effidently Identifying needed data.
obtaining and reviewing those data, and
reaching regulatory conclusions
regarding the continued registrability of
pestiddes, EPA initialed its Registration
Standards and Data Call-In programs.
Through these programs, EPA has been
reexamining by current standsrds the
health and environmental safety of
pestiddes.
Pestidde products are normally
formulations of one or more pestiddally
active chemicals (the active ingredients)
combined with one or more pestiddally
inert ingredients. Products are regulated
primarily on the basis of their
pestiddally active ingredients. There are
approximately UOO individual active
ingredients, which the Agency has
combined into basic active ingredient
groups that may be regulated together as
active ingredient "cases" (e.g., salts and
eaten of the same chemical). A review
of the available data oa each active-
ingredient case and its use culminates in
the issuance of a Registration Standard
for the group of individual active
ingredients which constitute a case.
A Registration Standard describes the
Agency's evaluation of the available
data and the conditions registrants must
meet in order to reregister pestidde
products containing the active
Ingredient These conditions typically
Indude requirements for submission of
needed additional data; compliance
with requirements for product
composition and labeling and p*1*"**"*,
Certain changes to application methods
or other label directions may also be
required, and some uses may be
restricted for use by or under the direct
supervision of certified applicators as a
condition of continued use.
EPA has established priorities for
conducting Its Registration Standard
reviews on the basis of dustan of
pestiddes registered for similar uses,
each as grain funtigaats and fungiddas.
Hgh-volune and food-use pesticides
have been among the highest priority
dusters. Thus far. 194 Registration
Standards have been completed
Because certain active ingredients of the
same "chemical family" an grouped
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Federal Register / VoL 64, No. 79 / Wednesday. April 28. 1968 / Notion
M077
Into one Registration Standard "am".
these 1M Registration Standards
Huieaaut «D individual active
Ingredients. An example of each a
grouping ii
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18078
Federal Register / Vol. 54. No. 79 / Wednesday. April 28. 1969 / Notices
contain* the nonet of the pesticide
active ingredients for which Registration
Standards were *nuffd prior to
Decraber 24.1988. This list includes the
Registration Standard case nana and
the todrtfdoai pastidd* actfe*
ingredients covered in each specific
Registration Standard (See Unit L A for
exploration of Registration Standard
eases.) Reregisfttttion Phases 3, through 4
do not apply directly to List A.
Reregistration of List A active
ingredients will be discussed in
paragraph E.1. of this unit
I Litti B, C. and D. Lists B and C will
each consist of ISO active-ingredient
cases of currently registered pesticides.'
In developing these lists, the Agency
anst first determine which chemical
substances should be grouped as a
single active-ingredient ease. The
criteria for setting priorities described
above (as well as other pertinent
factors) will then be used to place
active-ingredient cases on List & C or
D. Because the due dates for several
subsequent sctions are based on the
date each list is published, the Agency
ir.tindt to issue Lists B. C and D, as
nearly ss possible on the exact dates
indicated in this unit Each of the lists
will be published in the Federal Register
with a brief discussion of the following:
A description of the various lists;
criteria for placement of active
ingredients on Lists & C. and D: tune
frame* for registrant responses; and
Agency contacts.
Eecb list will be sent by certified mail
to the registrant* holding registrations
for products containing the pesticide
active ingredients included on the
specific lists. EPA will slso send
instructions to registrants of List B. C
acd 0 pesticides on how to respond in
Phaser
B. Phate 2—Registzant*'Intent to Sea*
Rsitgistration
1. Lilts B. C andD. In Phase 2 of the
!stration process, the registrants of
pesticide active ingredient
identified on Lists B. C, aad 0 an
required to respond to the i
concerning their intent to i
nregistratioiL If a registrant intends to
include:
(a) Identification of data reqoired by
regulations to support the registration of
the pesticide active ingredient
(b) Identification of data that wen
previously submitted to support the
registration but an inadequate to meet
such regulations,
(c) Identification of required data that
have not previously been submitted to
the Agency.
(d) A commitment to replace or
submit any required data or an offer to
share in the coat of generating such data
within specified periods of time.
For the purpose of a registrant's Phase
X response, data an to be considered
inadequate if the registrant cannot
certify the availability of raw data boa
the study, er if the data wen first
submitted to EPA before January 1. ItTO
(unless the registrant demonstrates to
the Agency that such data should be
considered).
Registrants of listed active ingredients
an required to submit their Phase 2
responses to the Agency within 3
months after publication of the list in the
Federal Register. If publication occurs
on the precise dates indicated in Unit
ILA. of this Notice, the Phase 2
responses would be due as follows:
List B Response— July 24. 1989
List C Response— October 24. 1989
List D Response— January 24, 1990
The Agency is given limited discretion
to extend these deadlines under
extraordinary circumstances beyond the
control of the registrant
If a registrant commits to produce
data in its Phase 2 response, the data
must be submitted within a reasonable
period of time as determined by the
Agency but not more than 48 months
after the date of the registrant's
commitment Time periods for
submission of data will be provided to
registrants when the Agency mails each
list, as directed by FIFRA '88. EPA is
required to suspend the registration of a
pesticide if progress is insufficient to
ensure the submission of the required
data in a timely manner or if the data
are not submitted by the date specified.
Again, EPA is given limited discretion to
extend deadlines under extraordinary
circumstances beyond the control of the
registrant The Report of the Senate
Committee on Agriculture dtes as
examples of such circumstances the
unintentional loss of laboratory results,
the unintentional destruction of
laboratory equipment or facilities, mafar
2. Cancmllatioe and removal. If a
registrant submits a notice of Intention
not to seek reregistratian of a pestidde,
a notice to that effect win be published
in the Federal Rsttetar. and the
registrant's response will be treated as a
request for cancellation. If a registrant
fails to submit the required Phase 2
response within the prescribed time, the
Agency is required to issue a notice of
Intent to cancel the registration. After a
80-day comment period the Agency may
cancel the registration or take other
appropriate action without a hearing.
If no registrant satisfies the Phase 2
response requirements for a particular
active ingredient EPA must publish in
the Federal Register a notice of intent to
remove the active ingredient from the
list and a notice of latent to cancel the
registrations of all products containing
the active ingredient After a 80-day
comment period the Agency may cancel
&ose registrations unless, during that
period another person acquires the
rights of a registrant and files a notice of
tBteet to reregister tb* pesticide and
within 120 days of the Fjdaral Register
notice, completes the Phase 2
requirements.
C Phate 3—Registrant*'Submission of
Information
I, List* B. C andD. In Phase 3 of the
reregistration process, each registrant
who is seeking reregistntion of a
pesticide active ingredient on List B. C
or D shell submit the following
information on the specific active
ingredient to the Agency:
(a) A summary of each previously
submitted study considered by the
registrant to be adequate to support
registration.
(b) A summary of each previously
submitted study that may not comply
with the requirements of section 3 of
FIFRA and the regulations issued
thereunder, but which the registrant
asserts should be deemed sdequale to
support continued registration.
(c) Reformatted data from each
summarized study submitted to the
Agency prior to January 1,1962, which
concerns chronic dosing, oncogenicity,
reproductive effects, mutagenicity,
neurotoxieity. teratogenicity, or residue
chemistry (including metabolism
•todies) or. where these studies are not
required reformatted of acute and
subchroate dosing data.
(d) Identification of data indicating
adverse affects.
(e) Identifidaton of additional data
that tbt registrant believes will support
registration.
(!) Certification of access to raw data.
(g) A commitment to submit data to
fiQ outstanding data requirements or an
offer to share in the cost of developing
such data.
Registrants are required to submit the
Information outlined above within 12
months after publication of the list on
which the active ingredient is identified
If publication occurs on the precise
dates indicated in Unit ILA. of this
Notice, the Phase 3 responses would be
due as follows:
List B Response—Aprfl 24.1990
List C Response—July 24.1990
List D Response—October 24.1990
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Ttdtnl Register / Vol. 54. No. 79 / Wednescay. April tt. 1980 / Notice*
To assist registrants to <
with the requirements of AIM X1
wffl develop guidance and Mod it to
M who have <
List C Notice—July 14,1BB1 (MmomOu
declared feeir intent to •
ttek reregistretion. Guidelines an
discussed in detail la paragraph C of
this unit
i. Gonct/btfana, ff a registrant of •
pestidde fails to rabmit the Information
nqnirad ia Phase 3 within tht
prescribed time period, the Agency is
•squired to cancel tht registntion
without hearing. ff tht registrant submits
tht required information hot it doas not
conform to guidelines established by
EPA. tht Armey oust dtttmint
whethtr tht registrant madt a food laith
attempt to conform IU submission to tht
guidelines, and if to. a iMtonabla time
wffl bt allowed to make necessary
changes or correction*, ff tht Agency
finds that a good faith attempt was not
made, tht Agency may issue a notice of
intent to cancel and. unless tht
registrant requests a hearing within 30
days, cancel the registration. Hie only
matter for resolution at such a hearing
shall be whether the registrant madt a
good faith attempt to conform its
submission to the guidelines.
D. Phase 4— EPA ten** of
SubaiaiiaaM and Jdeatifiaatiott of Data
Copt
b Phase 4. EPA is required to review
the date and information submitted by
registrants during Phases X and S, and to
Identify date gaps mdependendy. To
assist ia this review, the Agency nay
require registrants to submit completed
copies of studies which have been
summarized, but in general, the Phase 4
review will identify date requirements
for which already submitted stadias are
adequate and those which warrant more
detailed review. It is possible mat a
detailed review of the date m Phate I
will reveal mat a study, which appeared
adequate based on the Phate 3
submission, D '•• to be replaced or
The Agency «, iMn required to
publish in the Federal Regbter the
outstanding date TaqalnaeaU far each
active ingrwfient and Lists B.C and D.
Concurrently, a notice ander section
*cX2KB) of FIFRA wffl be isewsd to
registrants requiring the aabuteioa of
the identified data.
The Agency is required to complete rts
Phase 4 review of registrant submissions
«ad publish the BOtic* of (he data gaps
within ths tine periods specified to
FEFRA *88 (assuming the planned Bat-
mbhcetkn dates, by the dates shown
below.
List B Notice-October 24.1990 fig
months after publication of List)
List O Notice—July 34, UtZ (33 awaths
after publication of Ust)
Toe rueee 4 nviawarooeas wul
resemble the process aaad to review
date onder the farmer Registration
however, that the review wffl proceed
more rapidly and efficiently since the
Agency wffl be reviewing summaries
and reformatted date to detarmhw
which an good candidates far Ban
detailed nview.
Rtngittntieat
Phase I culminates the reregistratioa
process under FIFRA *•. ft requires the
Agency to conduct a thorough,
comprehensive examination of aO date
submitted in support of reragistraoon.
Based on ui» review, EPA will either
reregister a pesticide or take other
appropriate regulatory action.
Once an the required date OB aa
active ingredient have been received
the Agency has 1 year to complete its
review and determine whether the
pesticides containing the active
ingredient an eligible for reregistntion.
ff they an eligible, the Agency mat
obtain any needed product-specific data
prior to reregistering individual
pesticide products. Registrants an
required to submit these date no later
than 8 months after a determination of
eligibility for nregistntioa. unless the
Agency finds that a longer period of
time is required to generate the data.
Once all the product-specific date
have been received, the Agency ia
required to review those date within to
days and to reregister the product or
take other appropriate action within •
months after receipt of the required
prodnct-tpedfic data.
1 Mas* Snrrigw of Lift A chcm/col*.
The Phase 8 review of List A chemicals
highlights some issues which wffl also
arise with the other lists. Of the 1M
Registration Standards issued to date. U
second round re views of the active-
ingredient cases have bees issued and
three more an m draft. While
theoretically the date base for a
pesticide active ingredient tmdngoing a
second round review should be
complete, or at least naariy so,
experience shows that most of (heee
second round reviews Identify a ***™*f*
of new date gaps, and a reregistratioo
decision must be postponed until theee
date an submitted and reviewed. This
situation results from several factors.
Including tier testing (u which (he
results of one study indicate (he need For
additional testing); revised guldelinaa; .
new date requireneata; and Inadequate
studies submitted by registrants.
For the active ingredients on Ust A
(active ingredients for which
Registration Standards have bean
issued), the Agency will identify
chemicals whose date bases an
complete enough to conduct a thorough
evaluation and make a reregUtretion
decision and those chemicals for which
more date an needed before
reregistration decision can be made. For
active ingredients wjjh essentially
complete date bases, the Agency wffl
achedule and conduct second round
reviews and issue date caO-m notices
for product-specific date. For chemicals
with leas complete date bases, the
Agency wffl develop an efficient process
for promptly requiring the additional
date needed to evaluate the active
ingredients, conducting second round
reviews when date are received, end
then calling in product-specific date. A
system and schedule are being
developed for completing reregistration
of the List A chemicals as soon as
possible within the 9 yean provided.
X. Dffinftion of nregittration. _
Registration of a pesticide under FIFRA
requires that EPA find that Hs use will
not result m unreasonable adverse
effects on people or the environment, m
fight of the continuing evolution of
scientific knowledge, and therefore
**•"!*"! da** needs for the evaluation
of a pesticide's risks, it wffl be
necessary for the Agency to define a
specific set of conditions that when
met wffl allow the Agency to make the
raregif trstion decision within the
deadlines established in FIFRA "a.
Although additional studies not now
anticipated may be needed in the future,
a reregistntion decision can then be
made once those conditions have been
met A definition of reregistntion might
mdnde, for example, completion and
satisfactory review of specific
categories of studies to provide
scientifically valid data which an
essential for the Agency to determine
that oat of a pesticide wffl not cause
unreasonable adverse effects and can
be reregistered. However, even after
nregistntioa, the Agency's obligation to
consider new date about pesticide's
affects continues, and date received
after raregistration may serve as the
basis for further regulatory action by the
Agency.
LFonnefdicuiao. The Agency must
also decide bow to present its decision
on nregistntioa and the procedures and
process to be followed in issuing those
decisions. Currently, EPA's
reregistration review of a pestidda
active ingredient Is prevented in the
-------
Federal Register / VoL SC No. 79 / Wednesday. April 38. 1986 / Notices
htm at the Registration Standard
doaenent The Registration Standard
summarises EPA's eveJaetioB of date
available for each sdeutifle dtodpiiM
tad describes the coaditfam that most
bt met before Ac Agency w& eeoaidar
Oeectrro mgredient eUgfUefor
reregisQ'eooBe However, rersgistretioii la
aot granted thi
Registration Staadard for either fte
i of the
active mgrediaat or iadividiial products.
f. Addressing btpoctt an Artfc/d*
EPA rermgnfreii the potential impact
of FIFRA tB on minor OM pestiddes.
Frequently, than ia insuffident
economic incentive for pesticide product
maoofactaren to Justify the timely
development of data needed to rapport
pesticide registration! for many small
scale, infrequently needed or specialty
pesticide uses. As discussed in its Policy
Statement on Minor Uses of Pesticides
(51 FR 11341. April 2, 1986), EPA
recognizes that me continued
availability of pesticides registered for
minor uses is important for the
production of a diverse food supply and
has taken an active role in addressing
the problem by giving minor uses special
attention in its regulatory activities.
FIFRA directs EPA to make data
requirements for minor uses
commensurate with the anticipated
extent and pattern of use and degree of
exposure of man and the environment to
the pesticide. FRFA 'SB also contains
provisions for reregtstration fee waivers
for active ingredients used solely for
minor uses, which indicate
Congressional intent that minor uses
should be accommodated.
Even pior to the enactment of FIFRA
•86. rereditration has had an impact on
the availability of pesticides for minor
sacs. Because EPA has given priority to
the review of high-volume and food use
pesticides, meet of the 194 active-
mgredieat eases for which the Agency
has already issued Registration
Standards are food use pesticides wt'
had both major and minor ate*. Ifinc.
eseg often lack suffidest maxket
potential to offset the coat of generating
data to meet statutory requirements for
laieglstiatien. As a result of 9Je .
Agency's issuing these RegMretion
Standards, for a number of minor use*
associated with the old pestiddee,
registrations have been vohmttrflr
withdrawn by registrants or suspended
and cancelled by the Agency for faflere
to meet data ceS-te requirements. Many
people believe the loss of existing
pestiddes far minor ases as a result of
dedciow by registrants not to support
raregistration will be accelerated under
FIFRA "SB.
Low-volume pestiddes and low-
volume uses of e major pestiddes ere at
Hak when die data requirements make
the generation of new data economically
unacceptable to the registrant When
were to no alternative pest control
method for a low-volume use, loaa of the
registered pesticide is likely to impact
•sen adversely.
m the pest the Agency has pnrsoed
polities designed to allow flexibility for
minor uses to the extent possible within
the context of FIFRA and the Federal
Pood, Drug and Coemetic Act (FFDCAL
One approach to this problem has been
to encourage third party organizations,
each as user groups and OU4
(Interregional Research Project Number
4, e nationwide cooperative effort
including EPA, the U.S. Department of
Agriculture, state agricultural
experiment stations, and industry), to
gather data needed to support continued
registration of minor uses which are not
supported by a registrant
The Agency ia aware that FIFRA '88
may place additional burdens on minor
oses, and will consider what can be
done to alleviate that burden. The
Agency is working with State lead
agendes to help ensure that user groups
and others are aware of the potential
impact of reregistration and of actions
that can be taken by users to aid
registrants in maintaining registrations.
m addition, the Agency ia developing
guidance for registrants and others on
how to determine data requirements for
minor uses and how to make the most
effective use of the Agency's existing
policies,
G, Guidance far Rengjitration Under
with goideimas to be issued by EPA.
Thfemdades both data which the
>with
data which.
believes to wmpi
^requirements and
FIFRA *» shifts a substantial portion
of the burden for the early review of
previously submitted data from EPA to
the registrants, m order for the Agency
ts review the data bases of more
efeesrieala m a shorter time, registrants
of List EC, and D active ingredients are
required to make the initial evaluation
of their data and to submit the results of
their review m the form prescribed to
Phase I. To assist registrants m
complying with the Phase S
requirements, FIFRA *88 requires EPA to
tame the following four seta of
guidelines. Although the law requires
net the four mandated guidelines be
issued by December 24. 1980, the
Agency wishes to make them available
•t soon as possible so that registrant*
wffl be able to begin preparing their
Phase t
> they may not fully comply with
reqdramenta, the registrant believes
should be relied upon.
Ukfamuttingguidtlinn, All studies
eubnflted to the Agency prior to January
limwMeh win[be relied upon for
ivregis&BOon and which mBcern
dironfo dosing, oncogsnidty,
feprodactfve effects. muUgeuidty,
Benraenfdty. temtogentdty, or residue
chemistry of the active ingredient must
be n£brme>ttod IB accordance with
guidelines to be issued by EPA. For
chemicals whose uses do not require the
date bated above, the registrants must
reformat acute and subchronic dosing
date sabmtttad prior to January 1.1982.
on which they intend to rely.
X Guideliae» for identifying advene
dote. Guidance must be given for
registrants to identify adverse data
(required to be reported by FIFRA
section 6|e){2)}. An Interpretive Rule
spedfyiat; what Information must be
m Phase 8,afl previously submitted
studies on which a registrant wishes to
rely must be summarised in accordance
leader section 6(a)(2)ia
expected to be published this year. A
brief guidance document will be
prepared explaining how to identify
adverse data, but the interpretive rule
will determine what data must be
identified.
4. Identifying data that may not meet
guideline*. Even though e study may not
comply IB aQ respects with EPA's
Peetidde Assessment Guidelines, its
•lyff t{ajinina« may be suffidently minor
that the data an still of some use to
•support rengistretion. In such a case,
the Agency might not reject the data
outright The registrants must be given
guidance as to when EPA might accept
sock data. The Agency I* preparing
checklists to make it easier for
registrants to screen their data for
acceptability. .
K. 40 CFR Part 1S8 Data Requirement*
m addHte to the guidehaea
spedficaBy required by FIFRA *88 to
assist registrants in preparing their
Phase*responses, the Agency plans to
provide guidance for interpreting the
data requirements. At the time the lists
an sent to registrants. EPA will provide
Information on how to identify the data
required through the regulations
paH.hrifn to data requirements (40 CFR
Fart SSfl to support specific nee
categories, and clarify current data
requtoements in terms of the conditions •
•nder which certain studies an
required. For example, while Part 188 -
indicates that certain studies an
"conditionally required" on e case-by-
-------
Federal Register / V0L 54. No. 79 / Wednesday. April 28. 1889 / "Notice!
18081
expt
nee allows the
, for
registrants, dati routinely required to
support registration of • pesticide for
The Agency plans to propose an
amendment to 40 CFR Part 188 this year.
which will include an update of Part 156
to include routinely required date which
to date have not been identified
specifically tat the date tables of Part
158. EPA also expects to propose other
amendments to add new date
requirements. For example, new storage,
transportation, and disposal date
requirements provided for in FIFRA '88
will be added, m addition, many of the
Pesticide Assessment Guidelines may
be updated and new ones developed.
For example, the Agency intends to add
neurotoxidty and immunotoxicity
testing guidelines. (The Senate
Committee on Agriculture, on reporting
this bill requested that EPA intensify
the degree of testing for neurotoxic and
behavioral effects, including testing
related to chronic exposure, prenatal.
and neonatal effects.) Also, the Agency
expects to have in place amended Good
Laboratory Practice regulations (GLPs;
current regulations an at 40 CFR Part
180) which expand the scope of the
testing required to be performed under
GLPs.
Revisions to Part 158 to add new
requirements will take place over the
next few yean. While registrants an
not required to identify is their Phase 2
response date gaps that result from
these anticipated new requirements,
such future requirements represent an
additional expense which must be taken
into consideration when mey decide
whether they wish to support the
reregistration of the pesitidde.
Therefore, the Agency intends to
provide registrants with a description of
the changes fas date requirements which
It anticipates.
L Other Cuidaoct
IB addition. FIFRA 16 mey require
changes to some existing refutations
end policies. For example, the Agency's
prior policy which made voluntary
cancellations effective upon receipt
(published in the Federal Register on
March 27.1967.52 FR 9937) has been .
•uperceded by FIFRA IB. Under FIFRA
16, the Agency must publish in the .
Federal Register a notice of receipt of •
request for cancellation or for an
amendment to delete one or more uses
before approving ft. The Agency is
evaluating Its policies and procedures
and will amend them as appropriate to
implement the new requirements.
There may also be other giridanna
which win be appropriate to issue as
cases regulations must be amended. In
others, a Federal Register Notice of
Policy Statement new PR (Pesticide
Registration) Notice, or Standard
Operating Procedure mey be
appropriate. The Agency is currently
evaluating its •*H«HM guidance **"f
policies to establish priorities for
revising and creating new guidance.
/ Enhancement of Automated Data
Processing Syttaat
Effective management of the process
of accelerated reregistntion requires
that the progress of each active
ingredient toward reregistration be
monitored from the initial mailing of the
chemical lists to registrants to the final
reregistntion of end use products.
Significant modifications to EPA's
existing date processing systems,
several new systems, and information
integration will be required to support
this process.
To facilitate the submission end
processing of study summaries,
reformatted old studies, and new date,
EPA will assess the utility of the
electronic submission of date to improve
efficiency. Systems may also be
developed to support the assessment of
date and the development and
documentation of scientific and
regulatory determinations about each
active ingredient In addition, increased
automation of EPA laboratory facilities
msy be required to support the effident
validation of. residue methods and other
ectivities related to tolerance
reassessment
m. Expedited Regtstntion
Because of budgetary constraints hi
1988 through 1988, EPA wea forced to
choose among competing priorities. The
Agency chose to concentrate its
resources on processing applications for
new pestidde active ingredients and
oew uf 4 on reregistratiOB
•ctivitu .ocessing of applications for
registration of pesticide products that
an identical or substantially similar to
another registered pesticide product
(referred to es "me-too" appucatione)
•K/f minor amendments to ft*M*>f
registrations wen given a lower priority.
This redirection of resources resulted m
• predictable backlog of -me-too"
L 18 requires that EPA <
processing of these two classes i
applications and authorises up to 12
million to be allocated from the fees to
be collected under the Act far that
purpose. Expedited consideration must
be given to applications for initial or
emended registration of products which
are similar to pesticides aJready
registered with EPA. In sddition. the
Agency is required to expedite certain
minor amendments (amendments not
requiring scientific review of date).
Under the expedited review
provisions, an applicant must be
notified, within 45 days after the Agency
receives an eligible application, whether
the application is complete. Within 90
days after the Agency has received e
complete application.Se registrant must
be notified in writing whether the
request is granted or denied. If it is
denied, the specific reasons for denial
must be given.
As of the effective date of FIFRA '88.
the Agency bad over 3500 "me-too"
applications and over 4500 amendments
pending. Based on past yean' receipts.
the Agency estimates that
approximately 8000 to 6500 more
applications will have been received by
the end of the fiscal year (September 30,
1989).
The short-term approaches to
implementing the expedited registration
requirements focus on attaining two
goals: to handle applications received
after December 24.1968. within the
statutory time frames (45 days to
determine if the application is complete;
90 days to decide whether to grant or
deny the application): and to process as
quickly as possible applications that
were pending with the Agency prior to
the effective date of FIFRA *88 (referred
to as backlog applications).
Cue action already taken which will
reduce the number of applications
received each year is the promulgation
of the regulatory amendments to
Pesticide Registration Procedures
published in the Federal Register on
May 4,1988. and effective in August
1968 (53 FR15952). These regulatory
revisions, often referred to as the "maxi-
package". define categories of
amendments to registration that do not
require review or approval by the
Agency prior to implementation by
registrants. Such amendments fail into
two categories: notifications to a
registration that require the registrant to
notify the Agency before the modified
product is distributed or sold (referred
to as "notifications'") ejuf modifications
not needing Agency approval or
notification. Although portions of the
Bud-package may have to be revised
(ej~ voluntary cancellations, described
in Unit ttR of this notice certain types
of amendments that previously required
Agency approval now do not need to be
reviewed, thereby reducing some
demand on Agency resources and
-------
/ Vet S4. No. T» / Wednesday. April ».
ettoBef
> reajstraat marketing c
The Agency has slreadytokea the
&nt slspa necessary to seduce the
backlog. The pending appttcatioM have
bMn sorted fint into broad categories of
those reqairinf either atiBimalor BO
administrative review (notifications)
and those requiring administrative
review (•£• product cbtuiatryt,
precauaoBajy labeling, as* dinettoea].
rat Agency mtsnds to reduce
substantially tht bocklog of app&caati
by the sod of September 1880.
To improve the efficiency of
processing appncationSi a front^nd
processing operation to tents eD
applications is being developed ad wffl
be to pkee this spring. TWe eentnlind
processing Bait wffl send onrycoiapleto
applications OB far review by the
product management teems. If an
application if found to be hwampleto.
the unit will generate a letter within the
statutory 45-day time frame enumerating
the sppbcation's «uftH««rt«« sad and
prooaaa chaafoa. the Agaoey wiB
ceeaah with the Kgdatedtndaaay
tht pofalie to obteia taaUaadto
under FffKA. Congress calculated the
initial iee levels to generate $14 million
per year based eatta number of
regialntioBS to aTA awards at the toe.
Initial fee* setabbshed ia the law are
S43 par registration tor ap to SO
registrations held by the same registrant
plus $100 per registration for each
additional regisfratfon ap to 300 held by
activttin
tffldeacy. (e4, aotomatod d*U
fnooiaaion).
Aa the Agency aaeka to efavp&iy tbe
^^^^tt^mit*^ M^MM^KAM - Jiilif !!• mt me^^^^m^
fagwmoai pnoKeat •oamoBai vjmaM
Biay ba aaediBd The prtauiy d*tt
ing aapport raqgirad to the abort.
p
appBcmtioa fraddog tyttaa*
d predict toreatory rywtema. Thaae
the application package back to the
applicant.
to addition, the Agency ia developing
guidance tor registrants' ate ia
preparing applications tor registration of
pesticide products. The Agency speade
g •iffrriBrant am/nm! (jf tiBC reviewing
applications that an piwriy done or that
reqmn several raaubmiasions. Improved
guidance wffl aid applicant! m correctly
completing the required faxms and
documents, thereby reducing the
Agency's review time end the number of
resubmissions necessary. A new
instruction booklet wffl also serve as a
training guide far Agency staff aad
contractors. The agency MS sent a draft
of the booklet to frede associations aad
others for oouDent
Longsf torn pleas feeee ea anJuatfag
the current registration prof
idesttfymgen«r
improvements wffl facffitate the fc«*«*H"g
of the inaaaaad mfomMtiaa tmrtnuj
to eliminate the appbcatiOB backlog and
to namtor mmphance wttbtfaa-Baw
atatxtory procaaaiag baea. hi addtttOB, •
atudy of the feasibility of providtog
direct Rgiatnat aocaaa to ftaddag
mformatioa wilt be eoaduetod
IV.
expedited i
regiatretioB actioaa wtf be i
Intensive lagiilatory procaai
to coat at Mat 680 amUfeaa i
year period provided by CoBmreaa.
AppfaBdaatoty tUA to SUO ariUoB af
thcM costs an axpactad to be BM* tnm
B ewdBBatfoB ef the OBTCB! aenrtee
bvei of EPA'e bodget fcr icrefMntiaB.
The remaining Bwoey k to be obtafeed
frost two new fees. (1) a reiugieliaUuu
fee for each active togredleat subiect to
raregistration, aad (Z) an annaal
regtetratiaa aiatnfceisai;a fae far aach
ettdaacy. Tfaa Ageacy wffl foeaeae the
d^lyoparatioaaofthe] *
teteodedto
i that can be adopted to
hicreaae efficiency aad predaettvty.
•fflioam
Maifa
Improvement P
atiuly ts being
tea a
patajtial changes to
registration araceea to
aad waivan. OvereJL
Isc abodd generate abu.. «§!•
aaflttam hi lanauuai B»A's
budgat far
regisUatkjo
i wffl ideaafy operational i
aanacessarily. and masefoie i
atreamtoa
-------
Federal Register / Vol 54. No. 79 / Wedneao!ay. April 26, 19B9 / Nolicet
1B083
paid by the time prescribed dw Agency.
by order tad without hearing, nay
cancel the restoration. The filial <°rm
also gives registrants the opportunity to
request cancellation of a registration in
order to avoid payment of fee* on a
registration the registrant may no longer
wish to rapport.
In future yean, the fees wiD be
adjusted to comply with the intent of
Congress that as nearly as possible, 914
million per year be generated.
Maintenance fees will be due on March
1 of each year.
A Rfngutmtiaa Feet
Additional money wffl be collected
from fees levied on the registrants of
each active ingredient which is subject
to reregistration. including those active
ingredients for which Registration
Standards have already been issued by
the Agency. The size of the
reregistration fees prescribed by PIFRA
18 is related to the amount of Agency
review required for reregistration.
Active ingredients with major food or
feed uses are to be charged SlSOOOO.
Active ingredients with no major food or
feed uses for which Registration
Standards have been issued (those on
List A) will be charged S5OOOO to
tlOO.000; those for which a Registration
Standard has not been issued (those on
Lists B. C. and D) will be charged
$75,000 to $150,000.
1. Calculation of the fee. Consistent
with the fee structure described above,
all the individual active ingredients
which would be included in an active-
ingredient case (see Unit LA.) will be
considered to be one "active ingredient"
for the purpose of the calculation of
reregistration fees.
The reregistration fee Is to be paid for
each active ingredient subject to
reregistration with the exception of the
active ingredients eligible for waivers,
discussed in Unit IV.&2. Registrants
who .are eligible for a Generic Data
Exemption because they aorehaee
registered pesticides la order to
formulate another registered product are
exempt from contribution to the
reregistration fee.
When there an two or
second in Phase 3). The schedule for
payment of List A fees is left to the
discretion of the Agency but wifl
depend in large part on the time
required to obtain and process the
required information on exempt or
nonexem
of the same active ingredient the fee
will be apportioned among all of the
nonexempt registrants by market share
for the past 3 calendar yean. When a
registrant chooses to withdraw support
for a registered active ingredient and
therefore does not contribute to the fee,
the fee to be paid shall be reapportioned
among the remaining registrants.
.- Although the reregistration fee is a
one-time-only fee. the law provides for
Lists E C. and D fees to be paid in two
installments (the fint in Phase 2 and the
pt status and market shares.
Before billing registrants of product!
«IM § particular active ingredient
for their proportional share (If any) of
the required reregistration fee, the
Agency will obtain through Phase 2
responses specific information on
whether or not a registrant's source of
the active ingredient is another
registered product This wffl enable the
Agency to identify accurately those
products which are exempt from the
reregistration fee. For three products
which an not formulated from a
registered source of active ingredient
each registrant will also be required to
furnish market share information to be
used in calculating the proportional
contribution required. Been non-exempt
registrant will also be afforded an
opportunity to claim eligibility for and
submit data supporting a small business
waiver. The required contribution by
each non-exempt registrant will be
generally proportional to that
registrant's market share on an active
ingredient basis for the preceding 3
yean. Nevertheless, a minimum
contribution will apply for those non-
exempt registrants who have no market
share, and the contribution may be
reduced for those registrants who are
eligible for e small business waiver.
£ Fee waiven and reductions. FDPRA
•58 contains several provisions for
exemptions and reductions, or partial
waivers, of the reregistration fees. Small
businesses, defined as those firms
having 180 or fewer employees end
average annual gross sales of chemicals
in the prior 3 yean not exceeding MO
million will receive a partial waiver o"
fees depending on their average anm
aales cf pesticides containing *h*
ptfUCT1" active ingredient
Antimicrobial pettidde active
ingredients having no registered food or
feed uses and with production under 1
million pounds of that active ingredient
an exempt from the reregistntion fee.
Antimicrobial pesticides with
production levels larger man 1 mfllion
pounds of active ingredient or having
uses on food or feed sites an subject to
die same fees as ouer types of
pesticides.
PIFRA 18 also provides lor
exemptions from fees for active
ingredients which an contained only in
pesticides registered solely for
agricultural or nonagricultural minor
uses. It for e single active ingredient
regardless of use pattern, the value or
volume of use is small, an exemption
will be given for that pesticide from the
reregistntion fee.
C Management of Fund*
PIFRA -SB states that there shall be
established in the Treasury of the
United States a reregistntion and
expedited processing fund. All fees
collected shall be deposited into the
fund and shall be available to the
Agency without fiscal year limitation to
carry out reregistntion and expedited
processing of eligible applications.
The fund will be a "Revolving Fund".
The formal definition of a revolving
fond, as published by the Government
Accounting Office (GAO). is a "Public
Enterprise Revolving Fund Account:
Expenditure account authorized by
Congress to be credited with collections.
primarily from the public that an
generated by, and earmarked to finance,
a continuing cycle of business-type
operations."
The revolving fund will receive funds
from fees paid by registrants. EPA will
receive an apportionment (approval to
spend funds) from the Office of
Management and Budget (OMB) after
eubmiasion and approval of an
apportionment request However, the
Agency is allowed to spend only the
amount that is in the revolving fund.
Money in the fund not currently needed
shall be maintained on deposit or on
hand, invested in obligations of the
United States or those guaranteed
thereby. The investments an made by
die Department of the Treasury with
input by EPA if requested
The funds received in the Revolving
Fund will be available to EPA forme
only for rengistntion and expedited
processing and will be "No Year" funds.
This means that the budget authority
remains available for obligation for an
until
ority
was made available an attained
FIFRA *88 require* the Agency to
provide Congress with an annual
accounting of the fees collected and
disbursed from the fund The revolving
fond has been established and the
budget process is underway. The
Agency is developing en accounting
system to track all funds received and
disbursed to meet annual reporting
requirements.
V. Storage, Transportation, and Disposal
re
indefinite period of time, usually
die objectives for which the auth
The 1968 amendments significantly
expand EPA's authority to regulate the
storage, transportation, and disposal of
pesticides. FIFRA '88 provides that EPA
may. by regulation or as part of an order
-------
FecWaJ
/ Vei 84. Kp. Tg / Wednesday. April a. 1969 f Nottoa
lamed nder secta I of FffRA (the
i deabag wtft caacaOatfoaaBd
11 quire mants _ .
or disposal of pestiddes. their
which My be eoBtaBiDelod<»Mfe svc»
pestiddes. The Afracy may nojrtiee
this aaaaftty throng* A« tapeeftksi of
date mi labeifeig reqofrementi for
pestidde ngisttatfoa, cad ftreegfe attar
excawpestickies. container*, rfamtae
(sues a* the rinetogi fas* eoBtaieenr),
and otbe? materials aontajstnated by
pestidde residues, M writ as the
mstttetian of recaB ptuv far swpeaded
Oed p'v^lmjtBi whicby is
dUcuaeedmUnHVlofthie
The mthorfty to regalate storage,
traasportatton. and disposal of
pesticide* must be exercised in a
carefully planned itep-by-*tep
approach, not only because of I
the
resources it will require, bat alee-
bacaeae the Agency aeedc store
mformatfon before priorities can be
established aad effective procedure*.
guidance, aad regulations can be
developed.
Although this regulatory effort wi3
require 3 yean or more for fall
implemeatabon. the Agency wiD begin
in 1988 to fadUtats belter disposal
practice* and waste sciniBnzeoan. EPA
will explore opportunities lor improved
disposal, transportation, and storage
through its outreach efforts, certffk
and framing program, information
exchange, aad policy pronotnem*
These efforts will help reduce
envraanenUl bans and
tbe
success of tbe Agency's regulatory
efforts wfaea afiy Bapleaesiad.
A. Storm. Thjiuportatioa, and
Tke Agency pleas to eetabbah
requirement* iar atarage, tnaeportatioB
and dispoaal of pestiddea through
revisions to existing regalabeea
(currently ia 40 CFR Part 16»V hi
developing regnlattaaa, the Afeacy wffl
taJwMoewiaideratioatheretaletaTy
intent of me
Recovery Act (RCRA^ as we! aa the)
Agency's experience ai *at prograjB.
Alrhnngri EPA wffl eoatiaae aa gather
tnfbnnatkB an methods of disposal of
excess stocks, which may attar ear
current knowledge of disposal
technology, the Ageaey plans to begin
immediate development of pesfldde
disposal criteria and procadarea to be
followed aader a section ft supe&sic* or
caaceBatfoB order. Tat t evjioaa t»
existing regnktioBt arc schedaledior
completion ia Decaabi
AXooaOv
The Agency is also aathotked ta>
require pesticide product tebanag to
include requirement* and procedan
the storage, transport*
battevee that such configurations should
be identified aad eliminated, aad that
should abo be Jdenttfied
of the peatidd*. coatainen, dneataa.ee
other •ateriala which auy cootaiB
reaidaeaofthepaatidde.
The Ageaey belfevas that it My be
The Agency wffl ntOn this
tort
•sing uuttnct support,
iderali
appropriate to require significant
labeling changes. However, artl
procedure* aad guidance an develops a*
«ui prescribed by reguletioaa, and «Bb1
tfansportattoc. storage, aad rtaipnaal
data an received from registrants ar
other source*, najor cangea ia labaliaf;
requirements may be premature.
C. Contamen onfQxiitmffKnsottt
T» reduce probkm* assodatad with
•test Federal and State agenda*.
group*, and private
a December 7, !«•&. to
oa the proposed
contract The contractor's findings wffi
fce uttd ia support of planned regulatory
pesticide containers, EPA it required la
conduct • study to examse to*
feasibility tf returaabie/refiUabls
containers, formulation* that facilitate
the removal of pesticide residues'frost
packaging, and the use of bulk storage
facilities. EPA must ptaavtlfat*
regulatjou for the deaige of nmuiiieii
which will eaaure that peaticide
eontainen will fadhuie naidwe
removal ufe UM. diapmal and MMM el
contaia«n. la addilion. EPA auat iawe
regulation* preacribtnc aethoda of
removiog peatiodea froai eonlaiaan
prior to dupoeai FIFRA 'Make
authorizes EPA to reqtue !**»»"§ aa
described ia paragrapB B of thia nait eai
to adopt rafuJatiooe lor the storefe,
trarapcrtatkm. and diepoeei of
eontainen, rinaalae. or other matarteJa
used to contain or collect txcaes or
sytlled peaticidea whkk have ban
2. Pntxute eentaintr omig*. By
December 1881 the Agency must
promulgate final refutations lor the
design of pesticide containers that will
promote asle storage and disposal The
regutstioB* meat ensure that the
~«"t« designs fadlitate (1) residue
removek(2) saieuae (94^ BO "spUab-
back" ar leakage): (3) diaposaJ of
container*; and (4} safe refill and reuse
ipeat
ndedi
auspended or ceocaikd
i. Cootootr and riauotf ttady. Tke
Afeocy ia required to oaadect a rtedj af
waya to aacourat* or reajute (1) the
return, refill aad rm m <£ pntidde
coatainen; (2) the deveiooavKt af
pesticide farmaJettcw th«t fadlUata
removal; and (8) the aec of balk i
system* taredace the mber of
costfaiaMn far disposal. The Agency
Buat ooeaoh wtth a wide ruga of
aflaetad aad tatateaii
detemiae the ttuSbfttr sad costs of the
Thai reavits of die container study
described to tfaU emt will be need in the
fecmatioBof Iheae regabtiooa. FaD
eompKanee with the proriaioas of theee
reguiatk»a ia raqnired beginning
DecemberIfBa. A Cooipbance Strategy
witt be developed aad iasaed along with
tfaeregBtaooBa.
8. At tiadf outBinsr rmidue
nmoval. By December MB1 the Agency
Buat proamlgate regnlaoaDs prescribing
proceduea and staadanb far removal of
pesticide* from eoatainers. The
regBJaaoBa may provide for (1) Triple
rinsing or the aquiveJeat residue
removal etaBdarda for pesticWe
removat (2{ procedta^M that caa be
implemented promptly for residue
raaaevat (9 regae/disposel of rinse
water andreaidite; and (4) coonflneBoa
of laifieieaieiits aadw nmA with
appMcabiearovujioMoffteReeoarce
ConaersatfOB. aad Recovery Act of 197S.
Using *e isJormation gained from the
•etedy. the Ageaey will
alternatives. A report
must be saondttad ID i
DecembetlBgaFroai
guidance, the Aconey BBterpreB)
oontainer study mandate ia broad
BOtmai
eommer
ighm
certain fonnolafloa* or packagiar BMTV
resiOjaes tatfo Die awvooBMeil {aeca\ aa
leakage ia*e grauae) w^tr). The Agency
promulgate Part Y" -^guktory
psocedirea nat > t far IrW
aBimiBisBtiDB ov tt^vwaaf of riaaatea,
4, SCcflr primacy. Under section 26 of
PIPRA. States which have approved
oomprTance programs arxf euruiuetneat
procaAires have primary enforcement
fespoBoiDiBty lor pesticxieBse
violations, aad eader section 4, States
wttt SB approved certfieaooe phn are
fespoBeroie far certuymg pesouue
appBcaleiswtn respect to mat State.
Bcgtetag • Deceober 1983. States may
not axarcfse pmnary eaforceBMBt
appKeaton eader section 4. ealess the
Ageay R«ai mat tbe State is carrying
oat an adeqeete program fc> <
-------
ftdml Resistor / VoL 54. No. 79 / Wednesday. April 28. 1988 / Notices
18085
compliance with die new regulations
*.. .«-• . «w
pertaining to p
A mean* of reviewing But* compliance
programs will bt developed along with
other regulatory revisions.
C Data Rfquinatmtt
FIFRA "88 further providM that EPA
may require registrants to aabmit date
regarding method* of safe storage aad
disposal of pesticides. Hie Agency
intends to investigate what date
requirements would be appropriate to
effect safe storage for excess quantities
of pesticide formulations. The Agency
has also noted a lack of formulation-
spedfic data on the best methods for
disposal and the environmental fate of
products that have been disposed of by
various methods. The Agency is
investigating what data requirement
would be moat useful and will amend
the Part 158 registration data
requirements as necessary.
VL Recall, Storage, aad Indemnification
of Suspended end Cancelled Pesticides
Under FIFRA '88, if the Agency finds
that recall of a pesticide which has been
suspended and cancelled under section
B is necessary to protect health or the
environment, a recall must be ordered
The 1988 amendments also deleted from
the law the requirement that EPA, upon
request must accept and dispose of
suspended and cancelled pesticides at
government expense. The costs of
storage are now to be shared by the
registrant and EPA according to a
formula detailed by the Act In addition,
indemnification provisions are altered
so that only end users and. under limited
circumstances, certain dealers and
distributors are automatically entitled to
indemnification payments from EPA,
end the cost is not to be bone by the
Agency budget
A Recall Provitioat
m general, if the registration of •
pesticide has been suspended and
cancelled and EPA finde that a rscaO to
necessary, the Agency can initiate either
a voluntary or a mandatory recall
If EPA finds that a voluntary recall
may be as safe and effective as •
mandatory recall the Agency anat
request the registrant to submit, within
ao days, a plan to recall the pesticide.
EPA must order die registrant to conduct
• recall in accordance with the phut
unless the Agency determines after aa
Informal hearing that the plan will not
protect health or the environment
The mandatory recall procedure,
issued as a regulation, may require that
registrants, distributors, or sellers of the
pesticide (a) make storage facilities
evailabls to receive pesticides being
recalled aad inform the EPA
Administrator of the location of each
facility, (b) accept aad store existing
stocks of pesticides: (c) on request of
persons holding such pesticides, provide
transportation of the pesticide to a
storage facility: and (d] take reasonable
steps to inform holders of the pesticide
of the recall regulations, provisions, and
transportation arrangements. EPA will
define the criteria for acceptable recafl
plans and aD requirements that mast be
fulfilled through the adoption of
regulations.
1. Financial ntourcft to conduct a
ncall. EPA also is authorized to require
registrants to give evidence of their
financial and other lesuuiues
demonstrating capability to carry out a
prescribed recall aad provide for the
disposition of the pesticide to the event
of suspension and cancellation. The
Agency will examine this authority aad
propose the format and the
circumstances where this authority can
best be need.
B. Storage Cott Rtimbunttnmt
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 pestidde that meets
criteria established by EPA. The plan
must be reviewed and approved by EPA.
Through the formula for reimbursement
set forth in FIFRA '88, both the Agency
and the registrant are given an incentive
to complete this process as
expeditiousry as possible. EPA is
required to reimburse registrants for
storage costs es follows:
(3) None of the ooets incurred before
the date of the submission of the plane
to EPA.
(2) One hundred percent of the costs
Incurred after the data of the submission
of an acceptable plan or the date of
cancellation of the pesticide, whichever
to later, bat before the approval ef the
plan by EPA.
(3) Fifty percent of the ooets iacomd
during the 1-year period beginning on
the date of approval of the plea or the .
date of cancellation of the pestidde,
whichever to later.
(4) None of the ooets incurred daring
me 8-year period beginning 1 year alter
the approval of the plan or the data of
cancellation, whichever to later.
(S) Twenty-five percent of the ooets
incurred miring the period begunine,
win the 84h year following the approval
of *he plan or tf^ date of f^ncrllatiflPa
whichever to later, and ending oa the
date that a disposal plaa for the
pestidde can be implemented
Although the provisions for storage
reimbursement are generally self*
executing. FIFRA *M does stete that any
plan for storage and disposal must meet
criteria established by EPA by
regulation. These criteria will be
established through regulations
scheduled for completion in December
1901.
C Indemnification Pnvitiont
The new indemnification provisions
require EPA to indemnify end users of
pestiddes that have been both
suspended and cancelled by making
payments from a general appropriation
called the lodgement Fund (SI U.S.C
1904), which to used to pay daims
against the government A buyer who is
not an and user may obtain
reimbursement from the seller of the
pestidde for losses caused by either
suspension or cancellation, of the
registration. The seller must reimburse
that buyer unless the seller gave written
notice at the time of sale that
reimbursement would not be provided
Pestidde dealers and distributors who
own a quantity of pestidds which has
been both suspended and cancelled are
also entitled to reimbursement from the
Judgement Fund if they suffer losses
because the person who sold to them to
insolvent (and that person hsd not
previously given notice that
reimbursement would not be provided).
These provisions for payment from the
Judgement Fund should result In less
delay In payment of those entitled to
indemnification than has been the case
in the past
Anyone else who suffers losses due to
the suspension and cancellation of a
pestidde may be reimbursed only if
Congress provides a line-item
appropriation for that purpose. This new
provision was not intended to change
EPA's **j«*
-------
/ Vol. 54. No. 79 / Wednesday, April 28. 1989 / Notice*
Notice will be published to
communicate tot notice requiiements to
tn* public.
Vtt CompOaBce Provision*
FXFRA previously gave EPA Ac
authority to require produeen of
pestiddes to keep certain records
regarding their product*, including ul«
and distribution records, and the data
that supported the registration*. Under
FIFRA *88. EPA can extend these
requirements for neordkeeping to
registrants and applicants for
registration as well
FffRA '88 also gives the Agency clear
authority to issue regulations that limit
the sale, distribution, and use of
unregistered pesticides if necessary to
prevent unreasonable adverse effects on
the environment and explicitly provides
that violation of any such regulation is
an unlawful act Under the former law.
the Agency's authority in this area and
ability to take action against violators
were not always clearly defined.
A. Books end Record*
The Agency may prescribe regulations
which require producers, registrants.
and applicants for registration to keep
records concerring their operations and
tile pesticides and devices produced, as
necessary fcr effective enforcement of
the Act. The current regulations at 40
GER Part 189 will be revised (scheduled
for completion in August 1991} to
include registrants and applicants for
registration.
B. Unnsiitend Peiticides
The Agency may, by regulation, limit
the sale, distribution, and use of
pesticides that are unregistered, or not
covered by the provisions of ao
Experimental Use Permit (section 5) or
Emergency Exemption (section 18), if
necessary to prevent such activities
from causing unreasonable advene
effects on the environment. The Agency,
in consultation with State*, will
determine the need for regulations to
address specific sitsationt where the
sale, distribution, or use of uaregisterad
pesticides could result in environmental
dak,
C FIFRA Enforcement Retpont Policy
There are a number of other changes
or additions to section 12 or FDFRA.
Unlawful Acts. For example, ft is now
unlawful fax '
fa) Refuse to prepare, maintain, or
•Botniit records or reports required by
various; sections of the Act
fb) Violate suspension orders issued
under sections 3(c)(2). 4. or 8.
(e) Fail to notify tb* Agency or
appropriate slate if in the possession of
a cancelled or suspended pesticide.
(d) Sabstit false mformetiee to the
Agency in support of a registration or
relating to tests oa a pestidde.
(e) Violate a regulation under section
8(a) or 19. A revised FIFRA Enforcement
Response Policy will be produced to
insure uniform enforcement of these
provisions across all EPA regions. The
revised policy is scheduled for
completion in December 1989.
D. Criminal Pvteltuf
Criminal penalties for knowingly
violating any provision of FIFRA by a
registrant applicant for registration, or
producer now include a fine of not more
than 850.000 or imprisonment for not
more than 1 year, or both.
Commercial applicators of restricted
use pesticides or other pesticide sellers
who knowingly violate the provisions of
FIFRA are subject to fines of up to
825.000 or imprisonment for up to a year
or both.
. Scientific Advisory Panel
The Administrator's Scientific
Advisory Panel (SAP), is s group of
independent non-government experts
who convene to advise the Agency on
major scientific issues under FIFRA. In
the past the SAP was required to be
reauthorized by Congress every 5 years.
FIFRA '88 makes the SAP permanent
DC.
Successful Implementation of FIFRA
'88 will require effective
communications OB many levels. The
Agency plans to communicate major
decisions and significant activities
according to individual Communication
Strategies which will be developed for
each action as H occurs. For example,
some of the activities for which
eommuaicatioB* are already being
planned ant the issuance of eachlist in
Phase 1. establishment of front-end
processing for expediting eligible
applications, cancellations (both
voluntary and for failure to comply).
issuance of guidelines and regulations,
major fee announcements, resolution of
major issues, and individual active
fngreoient dedsioQs.
to many eases, actions and dedsioos
will be published in the Federal
Register. FIFRA *98 requires publication
in the Federal Register of the chemical
lists, all regulations, and certain other
notices, b •4*ttM> there may be other
actions and notices that the Agency will
publish to tfae Federal Register to
increase their availability.
• Communication strategies generally
•ailing information to interested
parties, and telephone contact with key
affected groups. The pestidde industry
(chemical nunafacturen, fonnulators.
dUtribvtan, and retaflersrind their
support industries (such aa
laboratories); pesticide users (farmers.
commercial applicators, institutions, and
household users); the food industry
(growers, processors, and retailers): and
environmental and public interest
groups, aa wefl aa individual concerned
dthrens each has an interest in EPA's
implementation of this new law. The
Conores*. EPA Regions. State and local
governments, other Federal agencies,
and international interests also must b*
kept informed.
The Agency has compiled an
extensive mailing list of organizations
known to be interested in vuious
pesticide-related issues. Persons who
have a particular interest in one or more
planned activities and wish to have
their names added to the mailing list
may contact the Field Operations
Division. Program Communications
Branch at the address listed at the
beginning of this notice under
"ADMCSST (telephone (703) 557-5017).
The Agency also is interested in
learning what specific types of
information various groups would like to
receive and suggestions on ways to
improve communications among all
interested parties.
A number of other activities are
planned to help inform various
interested groups and individuals. A fact
sheet and informational charts
describing the law have been distributed
to EPA'* regional offices. States, and
other interested parties. The fact sheet
has also been mailed to every pestidde
registrant The Agency plans to
partidpate in seminars, conferences and
meetings around the country where the
subfsct of FIFRA *88 and related Issues
wfll be covered.
Dated: AprilJnXUBB.
Vtatsr|.RkBaa.
AeOag Astittent Administrator for AM
-------
PESTICIDE REREGISTRATION PROCESS
PHASE 1
EPA
PHASE 2
REGISTRANT
PHASE 3
REGISTRANT
PHASE 4
EPA
PHASE 5
EPA
PUBLISH
LISTS
RESPOND
IDENTIFY
DATA GAPS
AGREE TO
FILL GAPS
SUMMARIZE
AND
REFORMAT
CERTIFY
RAW DATA
"FLAG-
ADVERSE
DATA
REVIEW
SUBMISSIONS
(2
IDENTIFY
DATA GAPS
PUBLISH
DATA GAPS
AFTER ALL DATA IN
(FOR ALL LISTS)
1 YEAR REVIEW
OF DATA
PRODUCT SPECIFIC
DATA DUE 6 MOS.
LATER
REVIEW OF PRODUCT
SPECIFIC DATA IN
90 DAYS
o
a
s
td
PAY FEE
PAY FEE
EPA
GUIDELINES
12/24/89
ISSUE DCI
REREGISTER
OR TAKE
OTHER ACTION - 6MOS.
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