BecyclBd/BeeycIabla - Printed with Vegetable Oi! Based Inks on 100% Recycled Paper (50% Postconsumer)
-------
-------
Contents
INTRODUCTION
I. PESTICIDE REREGISTRATION
A. Reregistration Process Background
B. Current Status of Reregistration
H. REREGISTRATION PROGRESS
A. REDs Completed This Quarter
B. RED Candidates for Fiscal Years 1994 and 1995
C. Suspended Chemical Cases
D. Data Submitted for Reregistration
m. OTHER MEASURES OF PROGRESS
A. Minor Uses
B. Rejection Rate Analysis
C. Product Reregistration Status
IV. TOPICS OF THE QUARTER
A. Minor Use Report Lists Unsupported Uses
B. OPP Workshop - Summary of Closing Remarks
V. SPECIAL REVIEW DECISIONS
VL CALENDAR OF EVENTS (FY 1994)
Appendix A. Cumulative Summary of Reregistration Actions
Appendix B. Other Sources of Information
2
2
3
4
4
5
7
7
10
10
12
13
14
14
14
17
20
21
24
-------
-------
INTRODUCTION
The Pesticide Reregistration Progress Report is
produced quarterly by the Special Review and
Reregistration Division (SRRD), Office of
Pesticide Programs (OPP), U.S. Environmental
Protection Agency (EPA), to provide information
on progress towards pesticide reregistration as
mandated under the 1988 amendments to the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA). Progress is reported both for the
current quarter of the fiscal year and cumula-
tively.
This issue of the Progress Report describes the
status of reregistration through the third quarter
fiscal year 1994 (FY 94). Sixty-one REDs have
been completed since 1991 representing 99
chemicals/active ingredients (AIs), 3,091 prod-
ucts, and 263 tolerances. Approximately 411
products have completed the process and have
been reregistered. Please see Appendix A for a
more detailed cumulative summary.
The fiscal year runs from October through September, and is divided into four quarters: the
first quarter consists of October, November, December; the second quarter consists of January,
February, March; the third quarter consists of April, May, June; and the fourth quarter consists
of July, August, September.
-------
I. PESTICIDE REREGISTRATION
A. Reregistration Process Background
EPA is required by law to reregister existing
pesticides that originally were registered years
ago when the standards for government approval
were less stringent than they are today. This
comprehensive reevaluation of pesticide safety is
critical to protecting human health and the
environment. In 1988, Congress amended the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) to strengthen and accelerate EPA's
reregistration program. The nine-year reregistra-
tion scheme mandated by "FIFRA "88" applies to
each registered pesticide product containing an
active ingredient initially registered before
November 1,1984.
In 1988, approximately 600 groups of related
pesticide active ingredients, or "cases," repre-
senting 1,150 active ingredients in 45,000 formu-
lated products, required reevaluation. As FIFRA
'88 directed, EPA divided these 600 cases into
four lists: List A, B, C and D.
List A - List A consisted of the 194 chemical
cases (or 350 individual active ingredients) for
which EPA had issued Registration Standards
prior to the effective date of FIFRA '88. Most
pesticides with food-related uses are on List A.
List B, C and D - The remaining pesticides were
divided into three lists based upon their potential
for exposure and other factors, with List B being
of highest concern and D of least. Some of the
classification criteria included potential for
residues of concern in food or drinking water,
significance of outstanding data requirements,
potential for worker exposure, Special Review or
restricted use status, and unintended adverse
effects to animals and plants.
FIFRA '88 established mandatory reregistration
timeframes and duties. The five phases of the
reregistration process are:
Phase 1: Listing of Active Ingredients - EPA
published Lists A, B, C, and D within 10 months
of FIFRA '88 and asked registrants of these
pesticides whether they intended to seek reregis-
tration.
Phase 2: Declaration of Intent and Identification
of Studies - Registrants were required to notify
EPA whether or not they intended to reregister
their products; to identify and commit to provid-
ing necessary new studies; and to pay the first
installment of the reregistration fee. During this
phase, EPA issued guidance to registrants for
preparing their Phase 2 and Phase 3 responses.
Phase 2 activities were completed in 1990.
Phase 3: Summarization of Studies - Registrants
were required to submit summaries and refor-
matted acceptable studies, "flag" studies indicat-
ing adverse effects, re-commit to satisfying all
applicable data requirements, and pay the final
installment of the reregistration fee. Phase 3
ended in October 1990.
Phase 4: EPA Review and Data Call-in's - In
Phase 4, EPA reviewed all Phase 2 and 3 submis-
sions and required registrants to meet any unful-
filled data requirements within four years. Phase
4 was completed in 1993.
Phase 5: Reregistration Decisions - In this
phase, EPA reviews all the studies that have been
submitted for a chemical case, and decides
whether or not to reregister products containing
the active ingredients in that case. A pesticide
will be considered eligible for reregistration if its
data base is substantially complete, and if it does
not cause unreasonable adverse effects to people
or the environment when it is used according to
product label directions and restrictions.
-------
B. Current Status of Registration
Figure 1 shows the status of supported chemi-
cal cases in Lists A, B, C, D, and all lists com-
bined, through the end of the third quarter fiscal
year 1994. Each column shows the total number
of supported chemical cases currently on each
list. Also shown are the numbers and percent-
ages of those cases that have REDs completed,
and cases that are in the category of
Awaiting Data/Data in Review. Of the total of
612 cases2 (representing 1,138 AI's) that were
eligible for reregistration in 1988, 405 (repre-
senting 590 AI's) still are supported while 207
are not supported by their registrants. A list of
REDs completed appears in Appendix A, Cumu-
lative Summary of Reregistration Actions.
Figure 1
Current Status of Reregistration - Supported Chemical Cases - Third Quarter FY 94
COMPLETED REDS AND SUPPORTED
CHEMICAL CASES
LIST
A
LIST
B
LIST
C
LIST
D
Reregistration Eligibility
Decisions (REDs)
22
Supported: Awaiting
Data/Data in Review
61
ALL
LISTS
15%
42 I61%| 344 185% I
(Total Supported
151) (Total 104) (Total 81) (Total 69) (Total 405)
Note: These numbers change frequently as the reregistration process continues. Percentage discrepancies may
result from rounding.
This number was originally 611 cases, which became 612 when two active ingredients were
separated to become individual cases.
-------
II. REREGISTRATION PROGRESS
A. REDs Completed This Quarter
This section summarizes RED production
during the third quarter of fiscal year 1994, and
summarizes the information in the individual
REDs.
In reviewing pesticides for reregistration, EPA
gathers a substantially complete set of data on
each chemical case, examines related health and
environmental effects, and attempts to mitigate
effects of concern. This evaluation and risk
management process is complete when EPA is
satisfied that the pesticide(s), used in accordance
with approved labeling, will not pose unreason-
able risks to human health or the environment.
When some or all uses of a pesticide are deter-
mined to be eligible for reregistration (or when
another regulatory conclusion has been reached),
EPA issues a Reregistration Eligibility Decision
(RED), usually embodied in a RED document.
About 14 months later, once certain product-
specific data and revised labeling are submitted
and approved, EPA begins reregistering single-
active ingredient products containing the pesti-
cides included in these REDs. Products that
contain active ingredients in addition to these
will not be reregistered until all of their active
ingredients are eligible for reregistration.
FY 94 REDs Production
Figure 2 shows the number of REDs scheduled
to be completed by quarter during fiscal year
1994, and the number actually completed
through the third quarter. Two REDs were
completed in the third quarter, covering a total of
3 chemicals and 28 products. So far, 14 REDs
have been completed in fiscal year 1994. The
target for the fiscal year is 38 REDs. A total of
61 REDs have been completed to date. Further
information about the completed REDs can be
found in Appendix A, Cumulative Summary of
Reregistration Actions.
Figure 2
BEDs Scheduled and Completed - FY 94
IS i
Q 10
|
:!
5 -•
.'.Z..........J REDs Completed
—m REDs Scheduled
1st Quarter
2nd Quarter
3rd Quarter
4th Quarter
-------
3rd Quarter REP Summaries
During the third quarter of fiscal year 1994,
EPA completed the REDs summarized below.
Maleic Hydrazide - Maleic hydrazide is a plant
growth regulator and herbicide that is used to
inhibit sprouting of potatoes and onions, suckers
in tobacco, and weeds, grasses and trees on/
among lawns, turf, ornamentals, non-bearing
citrus trees, rights-of-way, airports and industrial
land. Most maleic hydrazide used in the U.S. is
applied to tobacco crops. All uses of currently
registered products containing maleic hydrazide
are eligible for reregistration.
Maleic hydrazide is of low acute toxicity, but
contains the contaminant hydrazine which has
been shown to induce tumors. Between 1976
and 1982, EPA conducted a Special Review of
maleic hydrazide which resulted in administrative
suspension and cancellation of the DEA-MH
formulation, and establishment of a 15 ppm
upper limit for hydrazine in the technical grade
product. This level alleviates any concern of
lifetime cancer risk from both dietary and worker
exposure.
Although it does not pose risks to ground
water, maleic hydrazide has the potential to
contaminate surface water and to drift. EPA is
requiring a surface water advisory statement to
address these concerns. Also, to mitigate risks
to non-target plants, the Agency is limiting
application rates at several sites to once per year.
For additional information, please contact
Suzanne Cerrelli at (703) 308-8077.
N6-Benzyladenine - N6-Benzyladenine is a
plant growth regulator used on certain trees,
calla lily tubers and spinach grown for seed. It is
considered a biochemical because it resembles
natural plant growth regulators and uses a non-
toxic mode of action. All registered uses are
eligible for reregistration.
N6-Benzyladenine is of moderate to low acute
toxicity but causes developmental and maternal
toxicity in laboratory animals. The potential for
dietary exposure is negligible, and applicator risk
will be mitigated by use of personal protective
equipment and restricted entry interval. Use of
N6-Benzyladenine is not expected to pose a
significant risk to terrestrial or aquatic organ-
isms, or to endangered species. For additional
information, please contact Ruby Whiters at
(703) 308-8079.
B. RED Candidates for Fiscal Years 1994 and 1995
Table 1 shows the RED candidates for fiscal
year 1994. It is likely that for some of these
chemicals, REDs will be postponed until the next
fiscal year. EPA completed REDs for two of
these chemical cases in the third quarter for a
cumulative total of 14 REDs completed so far in
fiscal year 1994. The target for this fiscal year is
a total of 3 8 REDs.
Table 2 shows the proposed RED candidates
for fiscal year 1995.
-------
Table 1
RED Candidates for FY 94
List A
Amitraz
Barium Metaborate *
Bentazon
ListB
Ethalfluralin
Fosamine Ammonium
Mercaptobenzothiazole
Difenzoquat
Fenitrothion
Hexazinone
Maleic Hydrazide ***
Metalaxyl
Methiocarb **
N6-Benzyladenine ***
Terbuthylazine
ListP
2,4-Xylenol Chlorine
Bromine * Hexacadienol Acetates **
Metolachlor Pronamide **
Oryzalin Tebuthiuron **
Picloram Vendex
ListC
Chloron-m-xylenol Lithium Hypochlorite *
DBNPA Piperalin
DCDIC Sodium Cyanide
Limonene
2- [(Hydroxymethyl)Amino] Ethanol **
m-Cresol Muscalure Peroxy Compounds *
Mineral Acids * Periplanone B ** Vegatable and Flower Oils *
* REDs were completed for these chemical cases during the first quarter of FY 94.
** REDs were completed for these chemical cases during the second quarter of FY 94.
*** REDs were completed for these chemical cases during the third quarter of FY 94.
Table 2
RED Candidates for FY 95
List A
Alachlor
Amitrole
Asulam
Benomyl
Bromacil
Captan
Chlorothalonil
Chlorpropham
Chlorpyrifos
Copper Compounds II
Copper Sulfate
Coumaphos
Cryolite
DCPA
Dicofol
Diflubenzuron
Diquat Dibromide
EPTC
Ethephon
Fenamiphos
Fluometuron
Linuron
Methomyl
Metribuzin
Nabam
Naled
Napthalene
Nitrapyrin
Norflurazon
Paraquat Dichloride
Phenmedipham
Prometryn
Propanil
Sulprofos
Terbacil
Terbufbs
Tetrachlorvinphos
Trichlorfon
Trifluralin
ListB
Bis(trichloromethyl)sulfone
Bronopol
Butralin
Dibromodicyanobutane
Methyl Isothiocyanate
Methylene bis(thiocyanate)
NPV Inclusion Bodies
Oxadiazon
Starlicide
TroysanKKlOSA
Vinclozolin
ListC
Alkyl Imidazolines
Ancymidol
BHAP
Busan74
Cellosolve Esters
Chlorhexidine Derivatives
Cosan 145
Dowicil 100
Hydroxyethyl Octyl Sulfide
Methyl Nonyl Ketone
Methyloxazolidines
Oil of Citronella
p-Chloro-m-Cresol
Propamocarb
Sodium Fluoroacetate
Tanol Derivatives
Triethylhexahydrotriazine
List D
Agrobacterium Radiobacter
Aliphatic Alcohols, C1-C5
Polybutene
-------
C. Suspended Chemical Cases
EPA may issue a Notice of Intent to Suspend
(NOTTS) a pesticide product based on a finding
that the registrant has failed to submit data under
the requirement(s) of a FIFRA section 3(c)(2)(B)
or a 4(d)(6) Data Call-In (DCI). Events that
may result in the issuance of a NOITS include
failing to provide adequate responses or data on
time during the reregistration process or the
Special Review process.
Suspension is an Agency action which affects
the legal status of a pesticide product registra-
tion. After a suspension becomes final and
effective, the pesticide registrant subject to
suspension may not legally distribute, sell, use,
offer for sale, hold for sale, ship, or deliver to
any person the product(s) subject to the suspen-
sion. The product registration, however, remains
in existence.
Suspension of the registration of each product
will become final unless, within 30 days of
receipt, one of the following actions is taken by
the registrant: 1) compliance with the Agency's
requirements is shown, 2) the registration is
withdrawn, or the use which triggered the re-
quirements is withdrawn, or 3) a hearing with
EPA is requested.
EPA's Office of Compliance Monitoring (OCM)
has initiated 713 NOITS actions for non-compli-
ance with FIFRA resulting in 112 product sus-
pensions from November 1989 to July 1994. In
other cases, various outcomes resulted; for
example, suspensions did not occur because data
were submitted after the NOITS's were issued,
or the matters were settled resulting in data
submission.
D. Data Submitted for Reregistration
While EPA has formally evaluated the risks of
only 61 chemical cases for which REDs have
been completed, the Agency actually has ob-
tained a substantial amount of information on the
remaining chemicals.
Figure 3 shows the total number of studies
received and reviewed by discipline for List A
chemicals. The studies were submitted in re-
sponse to the Registration Standards issued prior
to FIFRA '88, as well as subsequent Data Call-In
Notices.
Figures 4, 5, and 6 show the total number of
studies received and reviewed so far for List B,
C, and D chemicals respiectively in response to
Data Call-Ins under FIFRA '88.
-------
Figures
List A - Total Studies Received and Reviewed as of Third Quarter FY 94
(A
•a
i
i
8
55
2,537
I Number of Studies Received
i Number of Studies Reviewed
Residue Environmental Re-Entry
Chemistry Fate Non-Dietary
ToxNon-
Cort*
ToxCort**
Ecological
Effects
Figure 4
List B - Total Studies Received and Reviewed as of Third Quarter FY 94
I
I
tn
t_i
o
s
1,338
Residue
Chemistry
I Number of Studies Received
1 Number of Studies Reviewed
1,913
Environmental
Fate
Re-Entry Non-
Dietary
ToxNon-
Cort*
Tox Cort**
Ecological
Effects
**TOX (CORT): Chronic Feeding, Carcinogenicity (Oncogenicity), Reproduction, and Developmental Toxicity
(Teratology).
* TOX (Non-CORT): These studies measure toxicity of pesticides in other than CORT studies.
-------
Figures
List C - Total Studies Received and Reviewed as of Third Quarter FY 94
129
Residue
Chemistry
1,039
305
5 0
-t-
Environmental Re-Entry
Fate Non-Dietary
ToxNon-
Cort*
Number of Studies Received
Number of Studies Reviewed
Tox Cort** Ecological
Effects
Figure 6
List D - Total Studies Received and Reviewed as of Third Quarter FY 94
I
•s
,5
96
Residue
Chemistry
554
H Number of Studies Received
H Number of Studies Reviewed
268
Environmental Re-Entry Tox Non-
Fate Non-Dietary Cort*
Tox Cort**
Ecological
Effects
**TOX (CORT): Chronic Feeding, Carcinogenicity (Oncogenicity), Reproduction, and Developmental Toxicity
(Teratology).
* TOX (Non-CORT): These studies measure toxicity of pesticides in other than CORT studies.
-------
III. OTHER MEASURES OF PROGRESS
A. Minor Uses
Table 2 provides information from the U.S. cancellations. The information here was first
Department of Agriculture, National Agricultural published in the RNN, May 1994. For further
Pesticide Impact Assessment Program information on any of the following pesticides,
(NAPIAP). The Reregistration Notification contact your NAPIAP State Liaison Representa-
Network (RNN) provides information to inter- tive or USDA at 301-504-8846.
ested parties on recent or impending pesticide
Table 2
Proposed Use Cancellations or Tolerance Revocations - Third Quarter FY 94
Chemical
Products
Affected Uses
Benomyl
Benlate
DuPont Company plans to delete MUSHROOMS from all
labels of the fungicide, benomyl, due to the cost of reregistra-
tion. They have recently notified EPA of this action, but EPA
has not yet accepted this deletion. DuPont will consider
supporting this use if another party wishes to develop the
required data. ;
Dicofol
Kelthane
EPA is staying (postponing) the effective date of a final rule
revoking the food additive tolerance for dicofol in or on
DPJED TEA. This revocation has been postponed because of
petitions submitted by the Dicofol Task Force (Makhtesnim-
Agan of North America, Inc., and Rohm and Haas Company)
andNACA.
EBDCs
Mancozeb,
Maneb, Metiram
EPA has announced that it plans to hold a hearing concerning
the request of Elf Atochem and Griffin Corporations to amend
all product labels of maneb, mancozeb, and metiram, which
were affected by the final EBDC Cancellation Order. The
amendment of these fungicide labels was requested to allow
the use of more than one EBDC active ingredient per season
per crop. Currently, these labels state, "If this product is used
on a crop, no other product containing a different EBDC
active ingredient may be used on the same crop during the
same growing season." The proposed amendments would not
change the current maximum allowable amount of EBDCs.
Granular Carbofuran
EPA has proposed to deny the request from FMC Corporation
to reinstate the use of granular carbofuran on CORN and
SORGHUM, but to grant FMC's request for an extension of
two years to the phase-out period on RICE. These three uses
of granular carbofuran are currently being phased out accord-
ing to the terms on an Agreement in Principle between FMC
Corp., and EPA that concluded the Special Review of granular
carbofuran in 1991. EPA finds no basis for reinstating either
corn or sorghum uses of granular carbofuran and the final date
of use on these crops remains 9/1/94. EPA is proposing the
extension of use on rice until 9/1/97 because there are cur-
rently no efficacious alternatives. Registration of reduced risk
alternatives to control rice weevil is being encouraged.
10
-------
Table 2, cont
Proposed Use Cancellations or Tolerance Revocations - Third Quarter FY 94
Chemical
Products
Affected Uses
Methazole
Probe
EPA has extended the existing stocks provision for the
cancellation of methazole for one year. This herbicide was
registered for use on COTTON. Retailers still have an
inventory of approximately 2,000 pounds of methazole and in
order to deplete existing stocks, EPA is allowing the distribu-
tion, sale, and use of the remaining methazole product with
revised supplemental labeling until 12/31/94.
Mevinphos
Phosdrin
EPA has received from Amvac Chemical Corporation, the sole
technical registrant of mevinphos, an insecticide and miticide,
a request to delete 26 sites from their labels and waive the 90-
day comment period. Therefore, these deletions are effective
as of 4/20/94. The deleted sites are ALFALFA, APPLES,
BEANS, BEETS, CARROTS, CHERRIES, CLOVER, CORN,
CUCUMBERS, DRIED PEAS, EGGPLANT, GRAPEFRUIT,
OKRA, ONIONS, ORANGES, PEACHES, PEARS,
PEPPERS, PLUMS, POTATOES, RASPBERRIES, SOR-
GHUM, SUMMER SQUASH, TOMATOES, TURNIPS (ALL),
and WALNUTS. EPA will notify you as soon as the final dates
for the sale, distribution, and use of the existing stocks of
mevinphos products labeled for these uses are finalized. A
petition has been submitted by the Sierra Legal Defense Fund
and the Farmworker Justice Fund to the EPA to immediately
suspend and cancel all uses of mevinphos due to worker
incidents. The Agency is currently considering this request
among other options.
Pentachloronitrobenzene
PCNB
EPA has revoked the tolerance for residues of PCNB on
BANANAS as of 4/13/94. This action has been taken
because no registered use for this fungicide on bananas exists
or has existed for more than six years.
11
-------
B. Rejection Rate Analysis
The Rejection Rate Analysis was developed to
address the high rate of rejected studies submit-
ted to OPP during the reregistration process.
EPA discovered that the submission of unaccept-
able studies is the most significant factor in
delaying REDs. Conducting replacement studies
can add several years to the reregistration
process.
EPA's study of rejection rates, with the coop-
eration and active involvement of the pesticide
industry, is an intensive effort to analyze rejected
studies and understand the reasons for rejection.
The resulting reports for each discipline should
minimize the reoccurrence of deficiencies in
future studies as the Agency enters the major
data submission phase of reregistration.
The Residue Chemistry, Toxicology, Environ-
mental Fate, and Occupational and Residential
Exposure Chapters of the Rejection Rate Analy-
sis all have been completed and are available
from U.S. EPANCEPI, telephone (513) 891-
6561, Fax (513) 891-6685. See Appendix B,
Other Sources of Information, for the publication
numbers of these documents.
The Ecological Effects chapter will be com-
pleted this summer.
12
-------
C. Product Reregistration Status
Figure 7 shows the status of products subject to
Reregistration Eligibility Decisions (REDs)
issued to date. "Current Decisions" covers those
products for which EPA should have made a
decision to reregister as of July 7, 19943 In this
category, 309 products have been reregistered,
14 registrations have been amended, 440 prod-
ucts have been voluntarily cancelled, 305 product
registrations have been suspended, and 348 still
need a decision, for a total of 1,416 products.
"Future Decisions" includes the 1,446 products
for which the Agency's product reregistration
decision is not yet due. In this category, 280
products have been voluntarily cancelled, 259
suspended, 102 reregistered, and 805 are pro-
gressing toward a reregistration decision.
So overall, a total of 411 products have been
reregistered, 720 have been voluntarily cancelled,
564 have been suspended, and 1,153 are pend-
ing.
Figure 7
Product Reregistration Status of 2,862 Products for 50 REDs* as of July 7,1994
FUTURE DECISIONS
NOT DUE YET (805)
CURRENT DECISIONS
CANCELLED (440)
REREGISTERED
(102)
SUSPENDED (259)
SUSPENDED (305)
CANCELLED (280)
OVERDUE (348)
* Involves 84 active ingredients. As of 7/7/94, EPA has issued product
specific data call-in's for 50 REDs covering/including 2,862 products.
According to FIFRA, the Agency should reach a reregistration decision on each product 14
months after issuance of a RED, provided that the registrant(s) submit(s) acceptable data on
time.
13
-------
IV. TOPICS OF THE QUARTER
A. Minor Use Report Lists Unsupported Uses
In April, EPA and the Interregional Research
Project No. Four (IR-4) presented an updated
report on the status of certain minor use pesti-
cides to the Minor Use Pesticide Working Group
at USD A. Members from this workgroup
represent the National Agricultural Chemical
Association (NACA), and the Chemical Produc-
ers and Distributors Association (CPDA) and
various grower groups concerned with minor use
pesticide issues.
The report included a printout of IR-4's candi-
date database which had been updated using
EPA's reregistration database. The updating
resulted in 250 modifications to IR-4's database.
The report listed 5000 Agricultural uses catego-
rized into four groups: use retained, use can-
celled, use not supported, and use currently
supported by IR-4.
Once these categories are confirmed by the
registrants for each pesticide, USDA's National
Agricultural Pesticide Impact Assessment Pro-
gram (NAPLAP) will notify grower groups
concerning those pesticides with unsupported
uses via the Reregistration Notification Network
(RNN). If you would like to receive notices of
the RNN concerning these unsupported pesticide
uses, call Kent Smith (USDA) at (301) 504-
8846.
Minor uses are uses of pesticides on crops
(hops and pineapples, for example) that are
generally grown on small acreages where rev-
enues from pesticide sales are too small for a
pesticide manufacturer to seek or continue
registration of a pesticide for production of that
crop. These pesticide uses have been especially
hard hit by reregistration. Many registrants have
elected not to support the reregistration of these
uses due to the cost of the required studies. The
IR-4 program is a national agricultural program
formed to obtain residue tolerances for minor use
pesticides. The IR-4 program will continue to
use this updated database to identify and priori-
tize unsupported pesticide uses for inclusion in
the IR-4 minor use program.
B. OPP Workshop - Summary of Closing Remarks
For those -who -were unable to attend the final
session of the OPP Workshop, the following is a
summary of closing remarks by Dan Barolo,
Director of the Office of Pesticide Programs.
I have enjoyed "the honeymoon," if you could
call it that—my first several weeks in this posi-
tion. However, it is now time to start making
decisions, and this inevitably will piss people off.
In dealing with OPP, be aware that I am asking
the staff to conduct business guided by the
following principles:
Teamwork - Work as a team with other
Divisions and Branches, rather than defen-
sively guarding your territory.
Take Pride/Have Some Fun - Unlike those
who work for public interest groups or
private industry, OPP employees have no
opportunity to be outraged. That's not our
job or our role. We are here to listen to both
sides, and then to make reasonable decisions
that fall somewhere between the extremes.
This is not an excuse for us to be bureau-
14
-------
crats, however; we must act, and act respon-
sibly, taking pride in our work.
People outside the Program are reminded
that the OPP staff is a good one. Let them
get on with their work, rather than besieging
them with phone calls, special requests, etc.
• Open Up -1 am committed to making
information available to the public. Let us
know how you think this can be done more
effectively.
• Make Decisions - OPP will make earlier and
timelier decisions. And be forewarned: the
Agency also will take earlier, timelier en-
forcement actions. (For example, when
studies are not received on time or are not
acceptable, products will be suspended.)
It is my intention to:
• Open Up the Decision Process - Involve
users/growers and others in OPP's registra-
tion and reregistration decisions.
• Target Resources - OPP does not have
enough resources to do everything. We
must and will drop some of our current
projects/activities so that we can do others
better.
• Automate - OPP should be able to have
access to (and provide) fact sheets on every
registered pesticide chemical, on an auto-
mated system that is updated regularly.
• Make Consistent Decisions - In sports, no
one likes it when the same plays are called
differently every time. The same is true in
pesticide regulatory matters, and we will try
to do a better job in this respect.
• Communicate our Accomplishments - OPP
is criticized roundly for what is NOT YET
DONE. The fact is that we have a LOT
going on (such as issuing REDs, reassessing
tolerances, registering new, safer chemicals,
etc.). We need to publicize what IS going
on, more widely.
• Delegate Authority - The authority to make
decisions is going to be pushed down to the
real people in the organization, so that our
decisions will be better grounded in solid
experience, and so the staff can take pride in
making these decisions work.
• Take Enforcement Action - We will suspend
products for which there are overdue or
rejected studies. Users are asked to make
sure their registrants (registrants of the
pesticides they depend upon) are delivering
the required studies.
• Knowingly Respect Others - We respect the
agricultural community in the U.S. We are
aware that you are not there pouring every
pesticide you can get everywhere in sight.
On the other hand, please understand and
respect our duty to protect.
Finally, this is what I expect from you:
• Users - Maintain pressure on registrants.
Make sure the registrants of pesticides you
use understand your local needs. Also, press
your user association to represent you fully.
• Environmental Groups - Understand the
limitations of the law. We need to find a way
to put a set of FIFRA amendments together
that will fill the holes that now exist in the
law.
15
-------
Registrants - Bring users into the picture.
Consider what they want and need as you
make product development plans and prod-
uct support decisions.
OPP - Don't be afraid to make decisions.
Answer questions; provide information in a
usable form (such as fact sheets).
Media - We don't have an active, informed,
involved media to carry our messages to the
world, or to let the public know what is
going on. We need your involvement.
Other Agencies - We need to build our
partnerships at both the Federal and State
level. USDA/Extension Service, FDA, the
States, etc., all need to be fully involved.
Help us find a way to accomplish this.
16
-------
V. SPECIAL REVIEW DECISIONS
This section summarizes the significant regula-
tory decisions made on chemicals in the Special
Review process during the third quarter, fiscal
year 1994. The formal Special Review process
for chemicals which have met or exceeded risk
criteria of unreasonable adverse effects is set
forth in 40 CFR Part 154.
Special Review decisions represent major EPA
actions which may ultimately cancel, deny, or
reclassify the registration of pesticide products,
because uses of the products may cause unrea-
sonable adverse effects on human health or the
environment. In addition, Special Review
decisions may establish policy or guidelines on
which other environmental decisions relating to
pesticide registrations are based.
Figure 8, Special Review Decisions Scheduled
and Completed, shows that OPP exceeded the
scheduled target completing four special review
decisions for the third quarter of FY 94. The
target for FY 94 is a total of eight special review
decisions. For further information on Special
Review chemicals, please call (703) 308-8010.
Figures
Special Review Decisions Scheduled and Completed - FY 94
5 -
4 -
3 -
2 -
1 -
0 -
f. •• •.-.-. •• '?] Speci
2
V \O s %
«. •- •- -• ^ ff ••
"" •. •*. "••
1st Quarter
al Reviews Completed
2
>r * :JTC."'
-;••>••-„ /• <• " •• »;
2nd Quarter
4
V'' *
-.-. *
'•'• >
Decision:; Scheduled
2
: g
| ,.„___ ! _ (
3rd Quarter 4th Quarter
3rd Quarter Special Review Decision Summaries
Delaney Action (Final Rule, Denial of Stay) -
EPA responded to objections and hearing and
stay requests filed in response to a final rule
revoking certain food additive regulations (toler-
ances) under section 409 of the Federal Food,
Drug, and Cosmetic Act. EPA is denying the
objections and hearing and stay requests on the
following section 409 food additive regulations:
1) benomyl- raisins and processed tomato prod-
ucts; 2) trifluralin - peppermint and spearmint oil;
3) mancozeb - bran of wheat; and 4) phosmet -
cottonseed oil. As a result of this denial action,
the above food additive regulations have been
revoked.
17
-------
Delaney Action (Proposed Rule Revoking
Certain Food Additive Regulations) - EPA
proposed to revoke certain food additive regula-
tions for several pesticides which EPA has
determined "induce cancer" within the meaning
of the Delaney Clause. The food additive regula-
tions being proposed for revocation include
captan, ethylene oxide, mancozeb, oxyfluorfen,
propargite, propylene oxide and simazine.
Delaney Action Final Rule; Mancozeb on
Raisins; Removal of Food Additive Regulation -
EPA removed the food additive regulation for
mancozeb on raisins in 40 CFR 185.6300. Data
show that this regulation is not needed because
any residues of mancozeb on raisins are covered
by the tolerance set for the corresponding raw
commodity (grapes).
Simazine (Notice of Intent to Cancel) - EPA
announced its intent to cancel the remaining
pesticide registrations for simazine products used
in swimming pools, hot tubs and whirlpool baths.
This action has been taken because the Agency
believes that the use of the products has the
potential to cause cancer and non-cancer effects
as a result of exposure to simazine in swimming
pools. The Agency believes that the risks from
this particular use exceed the benefits derived
from the use. The notice of intent to cancel was
signed on June 28 and published in the FR on
July 6. The cancellation becomes effective in 30
days unless a hearing is requested. No further
sale, distribution, or use of existing stocks of the
cancelled products will be allowed. All other
registrations for these uses of simazine were
previously voluntarily cancelled.
Wyoming Toad Issue - The Wyoming toad has
been on the Endangered Species list since 1984.
A March 1994 revised Biological Opinion by the
Fish and Wildlife Service (FWS) listed 43 active
ingredients as likely to jeopardize the continued
existence of the Wyoming toad, and recom-
mended that EPA implement "reasonable and
prudent alternatives" to protect the toad from
these pesticides. EPA headquarters worked in
conjunction with EPA Region 8, the Wyoming
Toad Recovery Group, FWS, and the U.S.
Department of Agriculture to coordinate the
1994 Toad Protection Program. As a result of
the program, a number of steps have been taken
this year to protect the toad:
1) Agreements were reached with all
Wyoming landowners within the range of
the toad to search high quality potential
habitat.
2) Landowners and Albany County Wyo-
ming mosquito districts agreed not to
apply pesticides in high quality habitat
areas until searches were completed and
no toads were discovered.
3) During June and early July, all of the
properties containing high quality habitat
were searched for toads.
4) No new toad populations were identified,
so spraying was allowed in areas where
the toad was not found.
The 1994 Toad Protection Program is a good
example of federal, state, and local officials
working together to implement provisions of the
Endangered Species Act.
Tolerance Revocations
During the third quarter of fiscal year 1994,
SRRD processed two tolerance related actions.
A description of each of those follows.
Pentachloronitrobenzene - The Agency re-
voked the interim tolerance (40 CFR 180.319)
for residues of the fungicide pentachloroni-
trobenzene (PCNB) in or on bananas. No
registered uses for PCNB on bananas remained
18
-------
trobenzene (PCNB) in or on bananas. No
registered uses for PCNB on bananas remained
and the use was not being supported for reregis-
tration. The notice, a final rule, was published in
the Federal Register on April 4, 1994 (59 CFR
17486).
Perthane - The Agency proposed to revoke the
tolerances listed at 40 CFR 180.139 for residues
of the pesticide l,l-dichloro-2,2-bis(p-
ethylphenyl)ethane (also known as Perthane,
Ethylan, or diethyl diphenyl dichloroethane) in or
on raw agricultural commodities. The action is
being proposed because all registrations of
Perthane have been cancelled. The proposed
notice was published in the Federal Register on
June 1, 1994 (59 FR 28326).
19
-------
VI. CALENDAR OF EVENTS (FY 1994)
4th Quarter FY 94
Twenty-four REDs are scheduled to be completed,
for a total of 38 since the beginning of FY 94.
Two special review decisions are scheduled to be
completed for a total of 10 since the beginning of
FY 94.
The Ecological Effects chapter of the Rejection
Rate Analysis is scheduled to be completed.
20
-------
Appendix A. Cumulative Summary of Reregistration Actions
The following is a cumulative summary of the
reregistration actions completed to date. OPP
has completed REDs and summary fact sheets
for each of the pesticides (cases) listed below.
Copies of the REDs and the fact sheets may be
obtained during the public comment period from
the Docket, Public Response and Program
Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, U.S.
Environmental Protection Agency, Washington,
DC 20460 Tel: (703)305-5805. After the
CUMULATIVE RED TOTALS
Total REDs = 61
Total Chemicals/ATs Covered = 99
Total Products Covered = 3,091
Total Tolerances Reassessed = 263
comment period, documents are available from
the National Technical Information Service
(NTIS), Attention: Order Desk, 5285 Port
Royal Rd., Springfield, VA 22161 Tel: (703)
487-4650. RED documents issued since April
1994 are available free of charge while supplies
last from the National Center for Environmental
Publications and Information (NCEPI), P.O. Box
42419, Cincinnati, OH 45242 Tel: (513) 891-
6561, Fax: (513)891-6685.
DATA CALL-IN SUMMARY
Fiscal Year
FY 1990
FY 1991
FY 1992
FY 1993
FY 1994
Number of DCIs Issued
27
159
97
93
72
Total 448
FY 91 REDs Summary
RED Case Name
1. Carbon and Carbon Dioxide
2. Dried Blood
3. Fosetyl-Al (Aliette)
4. Heliothis zea (NPV)
5. Methoprene
6. Potassium Bromide
7. Propionic Acid
8. Silicon Dioxide/Silica Gel
9. Sodium and Calcium Hypochlorites
10. Sodium and Potassium Nitrates
11. Sodium Diacetate
12. Sulfur
13. Warfarin
List
D
D
A
A
A
A
D
D
A
D
D
A
A
Date
Signed
9/91
9/91
12/90
12/90
3/91
6/91
9/91
9/91
9/91
9/91
9/91
3/91
6/91
# Chemicals/AIs
Covered
2
1
1
1
1
1
1
2
2
2
1
1
2
# Products*
Covered
9
3
! 2
1
63
2
14
75
770
6
2
332
76
Total
Tolerances
0
0
24
0
23
0
0
0
0
0
0
0
0
Totals
18
1,355
47
* The number of products listed reflects the number registered at the time the RED was completed. This
number is constantly changing.
21
-------
FY 92 REDs Summary
RED Case Name
14. Alkyl Amine Hydrochloride
15. Allium Sativum (Garlic)
16. Bone Oil
17. Capsaicin
18. Chlorinated Isocyanurates
19. Citric Acid
20. Ethylene
21. Hepfachlor
22. Indole-3-Butyric Acid (TOA)
23. NosemaLocustae
24. Putrescent Whole Egg Solids
25. Soap Salts
26. Sodium Hydroxide
27. Streptomycin
28. Zinc Salts
Totals
** \foluntarily cancelled
FY 93 REDs Summary
REP Case Name
29. Biobor
30. Boric Acid
Sl.Butylate
32. Cedarwood Oil
33. Daminozide
34. Eugenol***
35. Glyphosate
36. Inorganic Halides
37. Iron Salts
38. Menthol
39. OBPA
40. Oxalic Acid
41. Oxytetracycline
42. PEP(phenylethyl Propionate)***
43. Silver
44. Sodium Lauryl Sulfate
45. Sulfuryl Fluoride
46. Thymol
47. Tris(hydroxymethyl)nitromethane
List
C
D
C
D
A
D
C
A
B
D
D
D
D
A
D
List
C
A
A
C
A
D
A
D
D
D
A
D
A
C
D
D
A
C
C
Date
Signed
8/92
6/92
**
6/92
9/92
6/92
9/92
3/92
8/92
9/92
6/92
9/92
9/92
9/92
8/92
Date
Signed
6/93
9/93
9/93
9/93
9/93
9/93
9/93
9/93
3/93
9/93
6/93
12/92
3/93
9/93
7/93
9/93
9/93
9/93
9/93
# Chemicals/AIs
Covered
1
1
1
1
5
1
1
1
1
1
1
2
1
2
2
22
# Chemicals/AIs
Covered
2
•7
1
1
1
1
2
2
3
1
1
1
3
1
1
1
1
1
1
# Products*
Covered
3
4
2
8
741 |
3
8
2
31
6
6
25
9
26
7
881
# Products*
Covered
12
189
14
5
4
5
56
35
5 i
1
15
4 [
7
5
65
2
1
5
9
Total
Tolerances
0
0
N/A
0
0
0
0
0
0
0
1
0
0
14
0
15
Total
Tolerances
0
1
3
0
0
1
126
0
0
1
0
0
2
0
0
1
0
0
0
Totals
32
439
135
* The number of products listed reflects the number registered at the time the RED was completed. This number is
constantly changing.
** \foluntarily cancelled.
*** Exempted from regulation as pesticides under Section 25(b) of FIFRA.
22
-------
FY 94 REDs Summary
RED Case Name
48. Barium Metaborate
49. Bromine
50. Lithium Hypochldrite
51. Mineral Acids
52. Peroxy Compounds
53. Vegetable and Flower Oils
54. 2-[(Hydroxymethyl) Amino]
Ethanol or Ethanolamine
55. Hexadecadienol Acetates
56. Methiocarb
57. Periplanone B
58. Pronamide
59. Tebuthiuron
60. Maleic Hydrazide
61. N6-Benzyladenine
Date * Chemicals/AIs # Products* Total
List Signed Covered Covered Tolerances
A 12/93 1 3 0
D 12/93 1 4 1
C 12/93 1 40 0
D 12/93 4 212 0
D 12/93 3 23 0
D 12/93 6** 32 0
C 3/94 2 3 0
D
A
B
A
A
A
B
3/94
3/94
3/94
3/94
3/94
6/94
6/94
2
1
1
1
1
2
1
18
22
1
18
12
26
2
0
0
0
46
15
4
0
Totals
27
416
66
* The number of products listed reflects the number registered at the time the RED was completed. This
number is constantly changing.
** One A.I., "essential oils" will become 24 A.Ls after the RED is issued; many of these will eventually be declared
inert ingredients.
23
-------
Appendix B. Other Sources of Information
For documents or further information on reregistration issues related to this progress report, please
contact the following sources.
I
The following publications are available from:
NCEPI
P.O. Box 42419
Cincinnati, OH 45242-0419
Tel: (513)891-6561
Fax: (513) 891-6685
Catalog of OPP Publications and Other Infor-
mation Media. March 1994
Publication Number: EPA 730-B-94-001
Lists titles and ordering information for many
types of documents published by the Office
of Pesticide Program.
Pesticide Reregistration Pamphlet May 1992
Publication Number: EPA 700-K92-004
Status of Pesticides in Reregistration and
Special Review (Rainbow Report). June 1994
Publication Number: EPA 738-R-94-003
Rejection Rate Analysis. Residue Chemistry
Chapter. June 1992
Publication Number: EPA 73 8-R-92-001
Rejection Rate Analysis Residue Chemistry
Guidance on Conducting Plant and Livestock
Metabolism Studies
Publication Number: EPA 738-B-92-001
July 1992.
Rejection Rate Analysis Residue Chemistry
Guidance for:
Storage Stability
Theoretical Concentration Factors
Raw Data Guidance
Publication Number: EPA 737-R-93-001
February 1993.
Rejection Rate Analysis Residue Chemistry/
Environmental Fate
Guidance for:
Conducting Rotational Crop Studies
Publication Number: EPA 738-B-93-001
February 1993.
Rejection Rate Analysis. Environmental Fate
Chapter. August 1993
Publication Number: EPA 738-R-93-010
• Rejection Rate Analysis Toxicology Chapter.
July 1993
Publication Number: EPA 738-R-93-004
• Rejection Rate Analysis Occupational and
Residential Exposure Chapter. August 1993
Publication Number: EPA 738-R-93-008
> Rejection Rate Analysis Residue Chemistry
Guidance for:
Updated Livestock Feed Tables
Aspirated Grain Fractions
Calculating Livestock Dietary Exposure
Number and Location of Domestic Crop
Field Trials
Publication Number: EPA 73 8-K-94-001
June 1994.
24
-------
Federal Register Publication of Lists A. B. C
andD
List A: FR 2/2/89, pages 7740-7750
ListB: FR 5/25/89, pages 22706-22714
List C: FR 7/24/89, pages 30846-43396
ListD: FR 10/24/89, pages 43388-43396
For information contact: (703) 305-5805
Status of Chemicals in Special Review.
April 1994
For information contact: (703) 308-8173
National Pesticide Telecommunications
Network (NPTlsn
For information about pesticide poisoning
symptoms and general information:
Tel: 1-800-858-7378; Fax: 806-743-3094
Comments
EPA welcomes your comments on this progress report or on activities related to reregistration.
Please address your comments to the following:
Attention: Ed Setren
Pesticide Reregistration Progress Report
Special Review and Reregistration Division (7508W)
United States Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
For more copies of this report (Publication Number: EPA 738-R-94-014) or to be added to the
"SRRD MABELS" mailing list, please write or fax to the following address:
U.S. EPA, NCEPI
P.O. Box 42419
Cincinnati, OH 45242-0419
Telephone: (513) 891-6561
Fax: (513)891-6685
25
-------
-------
-------
o
—. /~v
5 O
01
o
-fa-
(O
rn c
9
CD
a
o'
CD
I
CD
(0 5J
O) >
Q- Si
-n
s
(A
------- |