Reregistration Eligibility Decision (RED): Ethephon


         -
         I        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                    WASHINGTON, D.C. 20460
CERTIFIED MAIL
                                                                         OFFICE OF
                                                                     PREVENTION, PESTICIDES
                                                                     AND TOXIC SUBSTANCES

                                                                      28  APR 1995
Dear Registrant:

       I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case ethephon.  The
enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the
data base of this chemical, its conclusions of the potential human health and environmental
risks of the current product uses, and its decisions and conditions under which these uses and
products will be eligible for reregistration.  The RED includes the data and labeling
requirements for products for reregistration. It also includes requirements for additional data
(generic) on the active ingredient to confirm the risk assessments.

       To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED."  This summary also refers  to other enclosed
documents which include further instructions.  You must follow all instructions and submit
complete and timely responses.  The first set of required responses are due 90 days from
the receipt of this letter.  The second set of required responses are due 8 months from
the date of this letter.  Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.

       If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative,
Wanda Daughtry at (703) 308-8171.  Address any questions on required generic data to the
Special Review and Reregistration Division representative, Judy Loranger at (703) 308-8056.

                                                     Sincerely yours,
                                                     Peter Caulkins, Acting Director
                                                      Special Review
                                                      and Reregistration Division
 Enclosures

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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)

1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-A Product Specific Data Call-In is
enclosed with this RED and must be completed and submitted within 90 days of receipt of this
package. The response consistes of a "Data Call-In Response" form and a "Requirements
Status and Registrant's Response" form. Additional generic may also be required to confirm
or support the assessment of the active ingredient. If generic data are required, Generic Data
Call-Ins are being sent only to certain manufacturing use registrants. Generic Data Call-Ins
are not being sent to end use product registrants. However, please note that instructions for
completing the Data Call-ins, which are incorporated as an Appendix to the RED, may
address both generic and product specific data. If you are an end use registrant, be sure to
follow the instructions for product specific data.

2. TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.

3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).

a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.

b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication "General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).

c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).

d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must

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REREGISTRATION ELIGIBILITY DECISION

                ETHEPHON

                  LIST A

                CASE 0382
           ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF PESTICIDE PROGRAMS
        SPECIAL REVIEW AND REREGISTRATION DIVISION

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                         TABLE OF CONTENTS
ETHEPHON REKEGISTRAT1ON ELIGIBILITY DECISION TEAM	i


      EXECUTIVE SUMMARY  	v

I.     INTRODUCTION	1

H.    CASE OVERVIEW	2
      A.   Chemical Overview  	2
      B.   Use Profile	2
      C.   Estimated Usage of Pesticide  	6
      D.   Data Requirements	7
      E.   Regulatory History	7

m.   SCIENCE ASSESSMENT	7
      A.   Physical Chemistry Assessment	7
      B.   Human Health Assessment	8
           1.    Toxicology Assessment	8
                 a.    Acute Toxicity  	8
                 b.    Subchronk Toxicity	9
                 c.    Chronic Toxicity	9
                 d.    Carcinogenicity	10
                 e.    Developmental Toxicity  	10
                 f.    Reproductive Toxicity 	11
                 g.    Mutagenicity  	11
                 h.    Metabolism  	12
                 i.     Neurotoxicity	12
                 j.    Reference Dose/Other Toxicological Considerations	12
                 k.    Other Adverse Effects 	14
           2.    Exposure Assessment	14
                 a.    Dietary Exposure   	14
                 b.    Occupational and Residential  	21
           3.    Risk Assessment	22
                 a.    Dietary  	23
                 b.    Occupational and Residential  	26
      C.   Environmental Assessment	27
           1.    Environmental Fate	 . 27
                 a.    Environmental Chemistry, Fate and Transport  	27
                 b.    Environmental Fate Assessment	31
           2.    Ecological Effects	31
                 a.    Ecological Effects Data	32

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comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.

e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.

4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.

5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)

By U.S. Mail:

Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001

By express:

Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202

6. EPA'S REVIEWS-EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.

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      Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
             	 217
      Attachment 7. Cost Share Data Compensation Forms, Confidential
            Statement of Formula Form and Instructions  	 219
APPENDIX G. FACT SHEET	229

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ETHEPHON REREGISTRATION ELIGIBILITY DECISION TEAM

Office of Pesticide Programs:

Biological and Economic Analysis Division
Joseph E. Hogue
George W. Keitt

Environmental Fate and Effects Division

Kathy Monk
Nick Mastrota
Dana Spatz

Health Effects Division

Jane Smith
Jeff Evans
Bonnie Cropp-Kohlligian
Robert Zendzian
Stephen Schaible

Registration Division

James Stone
Mark Perry

Special Review and Reregistration Division

Carol Stangel
Judy Loranger
Economic Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Risk Characterization and Analysis Branch
Occupational and Residential Exposure Branch
Reregistration Support Chemistry Branch
Toxicology Branch I
Science Analysis Branch
Fungicide-Herbicide Branch
Registration Support Branch
Policy, Planning and Operations Branch
Reregistration Branch

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                        (1)    Terrestrial Data	32
                        (2)    Aquatic Data	33
                        (3)    Non-Target Insects Data	34
                        (4)    Non-Target Plants Data  	34
                  b.    Ecological Effects Risk Assessment	36

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION	42
      A.    Determination of Eligibility	42
            1.     Eligibility Decision 	43
            2.     Eligible and Ineligible Uses  	43
      B.    Regulatory Position  	43
            1.     Tolerance Reassessment	43
            2.     Risk Mitigation  	53
            3.     Endangered Species Statement  	54
            4.     Labeling Rationale	55
      V.    ACTIONS REQUIRED BY REGISTRANTS  	59
      A.    Manufacturing-Use Products	59
            1.     Additional Generic Data Requirements	59
      B.    End-Use Products 	59
            1.     Additional Product-Specific Data Requirements	59
            2.     Labeling Requirements for End-Use Products	60
      C.    Existing Stocks  	74

VL  APPENDICES	75
      APPENDIX A. Table of Use Patterns Subject to Reregistration 	77
      APPENDIX B. Table of the Generic Data Requirements and Studies Used to
            Make the Reregistration Decision	89
      APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
            Reregistration of Ethephon  	  103
      APPENDIX D. List of Available Related Documents  	  129
      APPENDIX E	  133
            PR Notice 86-5	  135
            PR Notice 91-2	  155
      APPENDIX F. Combined Generic and Product Specific Data Call-In	  161
            Attachment 1. Chemical Status Sheets	  181
            Attachment 2. Combined Generic and Product Specific Data Call-in
                  Response Forms (Form A inserts) Plus Instructions  	  185
            Attachment 3. Generic and Product Specific Requirement Status and
                  Registrant's Response Forms (Form B inserts) and Instructions
                   	  191
            Attachment 4. EPA Batching of End-Use Products for Meeting Data
                  Requirements for Reregistration	  199
            Attachment 5. EPA Acceptance Criteria 	203

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GLOSSARY OF TERMS AND ABBREVIATIONS

AE Acid equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking water) lifetime
exposure at which adverse, non carcinogenic health effects are not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such as a
terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized As Safe as designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to municipalities and other organizations when
emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to cause death
in 50% of test animals. It is usually expressed as the weight of substance per weight or volume of water, air or feed,
e.g., mg/L, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of the test
animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of substance
per unit weight of animal, e.g., mg/kg.
LD,0 Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOC Level of Concern
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate contaminants in
drinking water under the Safe Drinking Water Act.
Mg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MOE Margin Of Exposure
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PPE Personal Protective Equipment
ppb Parts Per Billion
111

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EXECUTIVE SUMMARY

This Reregistration Eligibility Decision document (RED) addresses the reregistration
eligibility of the pesticide ethephon.

Ethephon is a plant growth regulator used to promote fruit ripening, abscission, flower
induction, breaking of apical dominance and other plant responses. Ethephon is registered for
use on a number of terrestrial food, feed and nonfood crops, greenhouse nonfood crops and
outdoor residential plants. Ethephon formulations include formulated intermediates and
soluble concentrates. Application is by broadcast to plant foliage by either ground or aerial
equipment. Ethephon may also be applied by hand sprayer to select home garden vegetables.

Ethephon was discovered in 1965 and introduced commercially in 1973 by the
AmChem/Union Carbide company as a plant growth regulator. The Union Carbide
registrations were sold to Rhone-Poulenc Ag Company. Cedar Chemical Corporation also has
registered ethephon products. The Registration Standard on ethephon (NTIS # PB89-109427)
was issued in September 1988. The Registration Standard continued the registration of
ethephon but required submission of environmental fate, toxicology, residue chemistry, and
environmental effects data. This RED document reflects a reassessment of all data which
were submitted in response to the Registration Standard.

The Agency has now completed its review of the ethephon target data base including
data submitted in response to the Registration Standard and has determined that uses of
ethephon as currently registered will not cause unreasonable risk to humans or the
environment. All currently registered uses of ethephon are eligible for reregistration. The
Agency is, however, requiring product chemistry, poultry metabolism (Guideline 171-4b),
residue analytical method in plants and animals (Guideline 171-4c/d), storage stability
(Guideline 171-4e), magnitude of the residue in peppers, cantaloupes, grapes, wheat forage
and hay, and cotton gin byproducts (Guideline 171-4k), magnitude of the residue in processed
sugarcane (Guideline 171-41), magnitude of the residue in poultry and ruminants (Guideline
171-4J), a batch equilibrium study on the degradate 2-hydroxy ethyl phosphonic acid
(Guideline 163-1), and acute and subchronic neurotoxicity (Guidelines 81-8 and 82-7). These
data are required to confirm the reregistration eligibility of ethephon.

The Agency has determined that there is limited potential for risk to certain nontarget
plants from use of ethephon on cotton, macadamia nuts, pineapples, tobacco, blackberries and
apples in North Carolina. The registrant has proposed reducing the use rate on blackberries
and on apples in North Carolina. In addition the Agency has reviewed information provided
by the registrant indicating that maximum use rates of ethephon are only required when certain
weather conditions exist. The Agency has determined that most uses of ethephon would be
below the maximum rate and the risk quotient would, therefore, be below the Agency's level
of concern. The Agency has concluded that with these risk reduction measures the risk to
nontarget plants from the use of ethephon will be limited.

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I. INTRODUCTION

In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
of an active ingredient and the generation and submission of data to fulfill the requirements.
The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregistration.

FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus, reregistration involves a thorough review of the scientific data base
underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the
need for additional data on health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criterion of FIFRA.

This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of ethephon. The document consists of six sections. Section I is the
introduction. Section n describes ethephon, its uses, data requirements and regulatory
history. Section HI discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregistration decision for ethephon. Section
V discusses the reregistration requirements for ethephon. Finally, Section VI is the
Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.

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            GLOSSARY OF TERMS AND ABBREVIATIONS

ppm     Parts Per Million
PRN     Pesticide Registration Notice
Q',      The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC     Red Blood Cell
RED     Reregistration Eligibility Decision
REI     Restricted Entry Interval
RfD     Reference Dose
RS      Registration Standard
TC      Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD      Toxic Dose. The dose at which a substance produces a toxic effect.
TEP     Typical End-Use Product
TGAI    Technical Grade Active Ingredient
TMRC   Theoretical Maximum Residue Contribution
TLC     Thin Layer Chromatography
WP     Wettable Powder
WPS     Worker Protection Standard
                                               IV

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      TERRESTRIAL NONFOOD CROP - Grass grown for seed, ornamental and/or
      shade trees (including apple, crabapple, carob, olive), ornamental herbaceous
      plants, ornamental nonflowering plants (conifers), ornamental woody shrubs
      and vines, tobacco

      GREENHOUSE NONFOOD CROP - Ornamental herbaceous plants

      OUTDOOR RESIDENTIAL -Ornamental trees, ornamental herbaceous plants
      and shrubs

      Target Pests:  N/A, plant growth regulator

      Formulation Types:

      Soluble concentrate/liquid - 3.9 to 55.4%
      Formulation intermediate -71.3%

      Methods of Application:

      The table below summarizes the methods of application and equipment used to
apply ethephon.  Use rates can be found in Appendix A.
Ethephon Rates and Methods of Application
Crop
APPLE






BLACKBERRY (OR.WA)
Purpose/Timing
To thin Spur Red Delicious (SLN, NC only); the high rate
is for use when soil moisture is substantially below normal.
To increase flower bud development in young trees, 2-4
weeks after full bloom
To thin crop, 10-20 days after full bloom
To loosen fruit for harvest, 7-14 days before normal
harvest date
With a preharvest drop control agent, to promote uniform
ripening without loosening, 14-21 days before normal
harvest, 1-14 days before expected harvest date
To eliminate undesired fruit on ornamental apples, at
flower bud to full bloom, before fruit set
To defoliate nursery stock (WA only), to allow digging
before onset of unfavorable weather
To hasten ripening and loosen berries,
3 days before expected harvest.

Equipment
ground spray
ground spray
100-400 gal/A
ground spray
300-400 gal/A
ground spray
50-500 gal/A
ground spray
200-400 gal/A
ground spray
20 gal (area not
spec.)
ground spray
ground spray
50-500 eal/A

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Ethephon was classified as a Group D chemical (indicating insufficient weight of
evidence of carcinogenicity for humans) based on available data. A Reference Dose (RfD)
was established as 0.018 mg/kg/day based on clinical signs of toxicity observed at 1.8
mg/kg/day in a 28-day oral human study. An uncertainty factor of 100 was used to account
for intraspecies variability and the lack of a NOEL.

The Agency has conducted acute dietary exposure and risk assessments using USDA
food consumption information to estimate the distribution of single day exposures through the
diet for the U.S. population and certain subgroups. The one day dietary endpoint of concern
of 1.8 mg/kg/day, based on cholinergic effects was derived from a 28-day oral human toxicity
study. Margins of exposure (MOE), estimates of how closely exposure comes to the dose of
concern (1.8 mg/kg/day), were calculated for various population subgroups. Agency
estimates indicate that acute dietary exposures to infants (less than 1 year of age) may be of
concern when the 95th percentile of exposure is used. However, the Agency has employed
numerous conservative assumptions in calculating the acute dietary risk relative to the
exposure. The Agency assumed that all food crops on which ethephon is registered have been
treated with ethephon and that maximum residue levels reported in or on unwashed, unpeeled,
uncooked commodities at the farm gate are present on all foods. However usage data indicate
that the treatment percentage of major infant foods on which ethephon is registered is < 10%
or even "negligible". The probable residue dilution that occurs in processed infant foods was
not taken into account. In addition, ethephon degrades fairly rapidly to ethylene, phosphate
and chloride in neutral and alkaline environments. Therefore, by the time the food has cleared
distribution channels and/or processing plants, residues at the dinner table are likely to be
significantly lower than high-end levels at the farm gate. The Agency believes that the acute
dietary risk values for infants listed in Section HI, B, 3 of this document represent an
unrealistic worst case situation and actual risks to infants are likely to be minimal.

A 48 hour restricted-entry interval (REI), as imposed by the Worker Protection
Standard (WPS), will be retained based on potential eye and skin irritation concerns. The
Agency has determined that this 48-hour REI must be increased to 72 hours when ethephon is
applied outdoors in arid areas. In addition, since ethephon is classified as toxicity category I
for eye irritation potential, protective eyewear is now required. Because there are no
toxicological endpoints of concern for dermal (systemic) or inhalation toxicity, the Agency has
determined that mixer/loader/applicator and postapplication/reentry data are not required to
support the reregistration of ethephon.

Before reregistering the products containing ethephon, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling
be submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing. After reviewing these data and any
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the
Agency will reregister a product. Those products which contain other active ingredients will
be eligible for reregistration only when the other active ingredients are determined to be
eligible for reregistration.
VI

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Ethephon Rates and Methods of Application
GRAPES, table (AZ, CA)
GRAPES, raisin (AZ, CA)
ORNAMENTAL CONIFERS
ORNAMENTAL DECIDUOUS TREES
ORNAMENTAL FRUITING TREES
(various named species)
BARLEY
WHEAT, SPRING
WINTER
CUCUMBER, SQUASH hybrid seed
production
PUMPKIN hybrid seed production
CUCUMBER, pickling
ORNAMENTAL HERBACEOUS
PLANTS (Bromeliads, hyacinth,
daffodil)
NURSERY STOCK (WA only)
Roses, tallhedge buckthorn
PEANUTS (Virginia Dept. of Agr,
and Consumer Svcs. Seed Laboratory
only)
To achieve more rapid and uniform maturity, foliar spray
when 5-30% of berries show color (2-3+ weeks before
harvest)
To hasten maturity, decrease acids, increase sugars, foliar
spray when 5-30% of berries show color
To remove dwarf mistletoe, apply as low volume foliar
spray before mistletoe seed dispersal
to remove leafy mistletoe, low volume dormant spray after
leaf drop through midwinter
To eliminate setting of nuisance fruits, low. volume foliar
spray at flower bud through full bloom before fruit set
To shorten internode length to prevent lodging, low
volume foliar application, after flag leaf is visible to boot
stage, but before awns emerge or sheath splits
same
same
To decrease male and increase female flower formation,
foliar spray at 2 leaf stage; repeat at 7-10 day interval if
germination is variable
To decrease male and increase female flower formation,
foliar application at 2-4 leaf stage; repeat at 3-10 day
intervals up to 6 applications/yr
To induce or enhance formation of female flowers, to
increase yield potential, two low pressure foliar
applications, first at 2-3 leaf stage, then 5-7 days later
To initiate flowering in Bromeliads (2500 ppm), reduce
stem topple in blooming hyacinths (1000 ppm), and
shorten stem length in potted daffodils (1000-2000 ppm),
foliar application when Bromeliads are desired size,
hyacinths blooms have not shown color, and daffodils are
4-5 inches tall
To defoliate nursery stock so as to allow digging of stock
plants before onset of adverse weather, foliar spray after
buds are matured. Use low rate on roses, high rate on
buckthorn.
To break dormancy in peanuts, moisten germination paper
with prepared solution [This is not a commercial use]

ground spray
ground spray
ground spray
ground spray
ground spray, hand
spray
aerial or ground
spray
same
same
ground spray
ground spray
ground spray
Hand spray
hand spray, backpack
spray
Germination tray

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       Use Practice Limitations:

       Do not apply through any type of irrigation system. Do not feed or graze
livestock in treated areas. Do not treat within 2 to 60 days of harvest, depending on
crop.

C.     Estimated Usage of Pesticide

       This section summarizes the best estimates available for the pesticide uses of
ethephon.  These estimates are derived from a variety of published and proprietary
sources available to the Agency.  The data, reported on an aggregate and site (crop)
basis, reflect annual fluctuations in use patterns as well as the variability in using data
from various information sources. The table below summarizes the pesticides use by
site.
"' -' ..- •"'" ,Ta v ^'*^._-„', v--;->'^;5f,^
Site
Cotton
Apples
Cherries
Tomatoes
Wheat
Barley
Peppers (bell)
Grapes
Tobacco
Walnuts
Almonds
Cucumbers
TOTAL
"$^'£j%'~~%vt£z£.7
^SQ'-^^ZWt :
lS&^;5?-^\
Acres
Grown
(000)
11,950
470
100
460
63,000
7,750
67
740
770
180
395
155
86,037

r* /.k. , ^ Z3j^.'^&$^$l&^& >:^^;f. * 2- '*"«
Acres Treated
at Least Once
(000)
Low High
1,400
15
20
25
60
15
5
10
5
5
, 1
3
1,564
2,500
40
30
100
120
50
15
50
25
20
5
5
2,960
^^^^^^^Sg«^^
Percent Crop
Treated
Low High
12
3
20
5
<1
<1
7
1
<1
3
<1
2
n.a.
21
9
30
22
<1
<1
23
7
3
11
1
3
n a
; * ^"^H'^tJ^L?^^
A«i*»'inltev£V?f

',~^£?-12y';r&^4fy^'''*~^\-~ •£-.Z;,f^S*
^witswc^, 1$^|* ~r:iJ$r*.
Pounds A.L .
Applied
(000)
1,300
8
6
15
10
5
4
3
8
4
2
0.2
1 365
2,550
30
9
60
20
18
12

35
18
10
0.4
2 777
V V , "' _ 1^ ^ ^
4"-1' ~. ,•-,• '-3
r-;-'- .: >-b.W^
Acre
Treatments
(000)
Low High
1,400
15
20
25
60
15
5

5
5
1
3
1 564
2,700
40
32
100
120
50
15

25
20
5
5
3 162

-------
In addition to usage estimates for the crops listed above, some negligible use
was also found on cantaloupes, ornamentals, oats/rye, peaches, pears, pecans,
plums/prunes, potatoes, pumpkins, soybeans, squash and sweet corn. No evidence of
recent usage was found on blackberries or sugarcane. No usage information was
available for pineapple.

D. Data Requirements

Data requested in the September 1988 Registration Standard for ethephon
include studies on product chemistry, residue chemistry, toxicology, environmental
fate, ecological effects and reentry. These data were required to support the uses listed
in the Registration Standard. Appendix B includes studies identified by the Agency for
currently registered uses needed to support reregistration.

E. Regulatory History

The Registration Standard on ethephon (NTIS # PB89-109427) was issued in
September 1988. The Registration Standard continued the registration of ethephon but
required submission of environmental fate, toxicology, residue chemistry, and
environmental effects data. This Registration Eligibility Decision document reflects a
reassessment of all data submitted to date in response to the Registration Standard.

III. SCIENCE ASSESSMENT

A. Physical Chemistry Assessment

Ethephon [(2-chloroethyl) phosphonic acid] is a plant growth regulator that
promotes fruit ripening, abscission, flower induction, and other responses by releasing
ethylene gas, a natural plant hormone.
Empirical Formula: C2H6C1O3P
Molecular Weight: 144.5
CAS Registry No.: 16672-87-0
Shaughnessy No.: 099801

-------
Pure ethephon is a white waxy solid with a melting point of 74-75 C. Ethephon
is very soluble in water, alcohol, acetone, and propylene glycol, only slightly soluble
in aromatic solvents such as benzene and toluene, and insoluble in kerosene and diesel
oil.

B. Human Health Assessment
1. Toxicology Assessment

The toxicological database on ethephon is essentially complete for
reregistration purposes. The Agency has determined that acute and subchronic
neurotoxicity studies are now required to support the continued registration of
ethephon products. These studies are not part of the target database for
ethephon and do not affect the reregistration eligibility decision.

a. Acute Toxicity

The table below summarizes the acute toxicity results for technical grade
ethephon.
^:£r'^
Test
Acute Oral LD50 (rat)1
Acute Dermal LD50 (rabbit)2
Acute Inhalation LC^ (rat)3
Eye Irritation*
Dermal Irritation (rabbit)4*
Skin Sensitization (guinea pig)5*
Result
1.60jf 0.13g/kg
5 +_ 0.9 g/kg
4.52 mg/L
not required corrosive in dermal study
Corrosive
negative
Category
m
m
m
I
I
N/A
'81-1; MRID 00029509
2 81-2; MRID 00029510
3 81-3; MRID 41685901
4 81-5; MRID 00029513
5 81-6; MRID 41154503
*Note: Data pertaining to acute eye irritation, dermal irritation, and dermal sensitization are not required to
support the reregistration of the TGAI. These data are presented for informational purposes.

-------
 b.     Subchronic Toxicity

        A 16-day oral human study showed plasma cholinesterase
 inhibition at 0.5 mg/kg/day (only dose tested).  Recovery occurred
 within  15 days.  Ten males and ten females were tested. No other signs
 of toxicity were observed.  (MRID 00066931)

        A 28-day oral human study showed no plasma or red blood cell
 cholinesterase inhibition at 1.8 mg/kg/day (only dose tested).  Five
 males and five females were tested.  The clinical signs/symptoms of
 organophosphate toxicity were reported. These include the sudden onset
 of diarrhea, urgency of bowel movements, stomach cramps or gas, an
 increased urgency and frequency of urination, and  disturbances in
 appetite. (MRID 00036510)

       In a 21-day dermal toxicity study, ten male  and ten female New
 Zealand rabbits were dosed dermally at 0, 25, 75, and 150 mg/kg/day,
 five days per week for three weeks.  Skin effects were observed at all
 doses (NOEL <25mg/kg/day). Effects ranged from erythema and
 desquamation at the lowest dose to acanthosis and chronic inflammation
 at the highest dose.  No systemic treatment related  effects were observed
 on body weight, food consumption, organ weight or histopathology.
 The systemic NOEL was greater than 150 mg/kg/day. (MRID
 41295901)

 c.     Chronic Toxicity

       A combined chronic/oncogenicity study was performed in
 Sprague Dawley rats.  Doses administered in the feed were 0,  300,
 3000, 10,000 or 30,000 ppm for 95 weeks to the males and 103 weeks
 for the females.  The doses administered relative to body weight were 0,
 13, 131, 446 or 1416 mg/kg/day for males and 0, 16, 161, 543 or 1794*
 mg/kg/day  for females. Plasma and erythrocyte cholinesterase was
 inhibited at all doses (NOEL <300 ppm). Brain cholinesterase
 inhibition was not observed.  A decrease in male body weight was
 observed at 10,000 ppm.   At 30,000 ppm body weight decrease was
 observed in both sexes.  Additional effects at 30,000 ppm were
 thyroglossal duct cysts,  kidney glomerulo-sclerosis and nephritis and
 biliary hyperplasia cholangiofibrosis. No carcinogenic effects  were
 observed.  (MRID 41139001)

      Ethephon was administered in the feed at doses of 0, 30, 300,
 3000 ppm (0, 0.75, 7.5  or 75 mg/kg/day) to male and female beagle
dogs. Due to toxicity/morbidity the high dose was reduced as  follows:

-------
75 mg/kg/day weeks 0-3; 50 mg/kg/day weeks 4-5;  25 mg/kg/day
weeks 6-24; 37.5 mg/kg/day weeks 25-104. Plasma cholinesterase was
inhibited at all doses (NOEL  <0.75 mg/kg/day). A NOEL for
erythrocyte cholinesterase inhibition of 0.75 mg/kg/day with a LOEL of
7.5 mg/kg/day was observed.  Histopathology showed smooth muscle
atrophy in the gut at 7.5  mg/kg/day with a NOEL of 0.75 mg/kg/day.
(MRID  00060359, 00147357)

       Ethephon was administered in the feed at doses of 0, 100, 300,
1000, or 2000 ppm (0, 2.7, 8.2, 28.5 or 52.1 mg/kg/day) to male and
female beagle dogs for 52 weeks.  A systemic NOEL of 1000 ppm (28.5
mg/kg/day) was observed for decreased spleen weight, body weight,
hemoglobin and hematocrit in the males. The females showed a
decreased spleen/body weight ratio for the same NOEL. Cholinesterase
inhibition was not determined.
(MRID  41135001)

d.    Carcinogenicity

      The chronic/oncogenicity study in rats summarized above showed
no evidence of treatment related tumors. (MRID 41139001)

      Male and female CD-I mice were administered ethephon in the
diet at 0, 100, 1000 or 10,000 ppm (0, 15.5, 156 or 1630 mg/kg/day)
for 78 weeks. An additional dose  level of 50,000 ppm was terminated at
12 weeks because of excessive morbidity and mortality.  No evidence of
treatment related tumors  was observed. A NOEL of 15.5 mg/kg/day
was determined for plasma cholinesterase inhibition.  At 1630
mg/kg/day male body weights were increased and female body weights
decreased compared with controls.  (MRID 41050801)

e.    Developmental Toxicity

      Rats were dosed by gavage at 0, 20, 600 or  1800 mg/kg/day on
days 6 through 15 of gestation.  At 1800 mg/kg/day, 14 of the 24
treated female rats died.  No toxic effects were observed at lower doses.
The NOEL for maternal and fetal toxicity was 600 mg/kg/day.  (MRID
00063745)

      Rats were dosed by gavage at 0, 125, 250 or 500 mg/kg/day on
days 6 through 15 of gestation.  No toxic effects were observed at any
dose. The NOEL for maternal and fetal toxicity was greater than 500
mg/kg/day. (MRID 41103001)
                      10

-------
        Rabbits (17/group) were dosed by gavage at 0, 50, 100 or 250
 mg/kg/day on days 6 through 19 of gestation.  The number of does with
 live fetuses were 10,  12, 8 and 5, respectively.  Resorptions were
 increased at 100 mg/kg/day and statistically significantly increased at
 250 mg/kg/day.  At 250 mg/kg/day does were depressed, ataxic, showed
 an increase of clinical observations and gross pathology in the gut. A
 NOEL for maternal and fetal toxicity of 50 mg/kg/day was observed
 (MRID 00085755)

       Rabbits were dosed by gavage at 0, 62.5, 125 or 250 mg/kg/day
 on days 6 through 19 of gestation.  Maternal morbidity, mortality and
 clinical signs of toxicity were observed at 250 mg/kg/day. Fetal toxicity
 consisting of decreased number of live fetuses per doe, increased early
 resorptions and post implantation loss was observed at 250 mg/kg/day.
 A NOEL for maternal and fetal toxicity of 125 mg/kg/day was
 observed.  (MRID 41557201)

       The data from the developmental toxicity studies show no
 evidence of a potential for developmental effects (malformations or
 variations) at doses that  are not maternally toxic.

 f.     Reproductive Toxicity

       In a two generation reproduction study, 28 Sprague Dawley rats
 per sex per dose were administered 0, 300, 3000 or 30,000 ppm (0, 15,
 150 or 1500 mg/kg/day) of the test compound in the diet. For the
 offspring a NOEL of 15 mg/kg/day and a LOEL of 150 mg/kg/day was
 set based on decreased F2b survival during lactation.  For the adults a
 NOEL of 15 mg/kg/day and a LOEL of 150 mg/kg/day was set  based
 on decreased body weight gain in the females at 150 mg/kg/day  and in
 both sexes at 1500 mg/kg/day.   No effects were observed on fertility,
 gestation, mating, organ weights or histopathology in any generation.
 (MRID 41508701)

 g.     Mutagenicity

       Ethephon was tested in Salmonella typhimurium strains
 TA-1535, TAS-1535,  1537, 1538, TA-98, and TA-100 with and without
 S9 activation at concentrations of 1.0-50 /wg/plate.  The test material was
positive for mutagenicity in strain TA-1535 with and without S9
activation.  (MRID 40412401)

       Ethephon was tested for clastogenic effects in the CHO cell
system at doses of 70 to 2000 ywg/ml with S9 activation and 200 to 2010
                      11

-------
/ug/ml without S9 activatipn.  The study was negative.
(MRID 40555301)

       Ethephon was tested for unscheduled DNA synthesis in the rat
hepatocyte system at doses of 25 to 1000 Mg/ml.  Cytotoxicity due to
acidic pH changes has been observed at 2000 Mg/ml and higher doses.
The study was negative.  (MRID 40555201)

h.     Metabolism

       Ethephon was administered in a single intravenous dose of
50 mg/kg and single and multiple oral doses of 50 and 1000 mg/kg to
male and female Crl:CD(SD)BR rats.  The oral Cmax (maximum
concentration) was reached at 1.3 and 1 hours for the 50 mg/kg dose and
1.9 and 2.5 hours for the 1000 mg/kg in  males and females respectively.
The t172 of the rapid excretion phase (A-phase) at the 50 mg/kg dose was
7 hours for both sexes and 4 and 9 hours at 1000 mg/kg for the males
and females respectively. Oral and intravenous doses were rapidly
excreted in the urine and accounted for 48 to 71 % of the administered
radioactivity. Approximately 7% was excreted in the feces.  Exhaled
ethylene was 10-20% and CO2 was less than 1 % of the administered
dose. The highest tissue concentrations were found in the blood, bone,
liver, kidney and spleen with no significant differences between single
and multiple dosing. No  significant differences were observed in the
excretion pattern with either sex or multiple dosing.  (MRID 41906101)

i.      Neurotoxicity

       The acute oral LD50 in the hen was determined to be 3800
mg/kg.  Two groups of 30 hens each were dosed orally at 3850 and
3160 mg/kg and observed for 21 days. The survivors were dosed orally
at 2370 mg/kg and observed for an additional 21 days.  Survivors were
necropsied and histopathology of the central nervous system was
performed.  No observational or histopathological evidence of
organophosphate type delayed neurotoxicity was observed.
(MRID 00144559)

       Because ethephon  is an organophosphate pesticide, acute and
subchronic mammalian neurotoxicity studies are now required.

j.      Reference Dose/Other Toxicological Considerations

       The RfD for this chemical was first assessed by the Health
Effects Division RfD Committee on March 8, 1988 and subsequently
                      12

-------
verified by the Agency RfD Work Group on March 23, 1988.  At that
time the RfD was based on a 16-day human study (MRID 00066931)
with a LOEL of 0.5 mg/kg/day (only dose tested) for plasma
cholinesterase inhibition. An uncertainty factor (UF) of 100 was used to
account for intraspecies variability and the  lack of a NOEL.  On this
basis, the RfD was calculated to be 0.005 mg/kg/day.  Subsequently, a
new chronic feeding study in dogs and a carcinogenicity study in mice
were submitted.

       The OPP/HED RfD Peer Review Committee determined on
February 10, 1994 that the reference dose (RfD) should be based on the
28-day study in human subjects (MRID 00036510).  Clinical signs of
toxicity were observed at 1.8 mg/kg/day (only dose tested) and included
diarrhea, urgency of bowel movements, urinary urgency and stomach
cramps.  An uncertainty factor (UF) of 100 was used to account for
intraspecies variability and the lack of a NOEL. On this basis the RfD
was calculated to be 0.018 mg/kg/day, the chronic dietary endpoint.

       The lexicological endpoints of significance for determining
dietary and occupational risk assessment are as follows:

       1) The acute (one day) dietary endpoint is based on clinical signs
       observed in the 28-day study in humans  at 1.8 mg/kg/day.
       Although clinical signs were observed early in the study, no
       plasma or red blood cell cholinesterase inhibition was evident.
       There was  some question as to the reliability of  the observed
       clinical signs.  For the purposes of risk assessment a margin of
       exposure (MOE) of 10 is appropriate since it is based on a human
       study. The Agency has determined  that  an additional uncertainty
       factor of 10 due to the lack of a NOEL is not appropriate for the
       acute dietary endpoint because this endpoint is near the NOEL
       for cholinesterase inhibition in the 16-day human study.  An
       additional factor of 10 would overstate the acute endpoint. It
       should be noted that some plasma cholinesterase inhibition was
       observed in the 16-day human study.

       2) There are no toxicological endpoints of concern associated
       with short term (one to seven days) or intermediate term  (1 week
       to several months) occupational or residential exposure because
       there was no evidence of (systemic)  toxicity by the dermal route.

       3) There is no cancer concern associated with this chemical.
       Ethephon is classified  as a Group D  chemical based on the
       "insufficiency of the weight of evidence".
                      13

-------
              4) The RfD is 0.018 mg/kg bwt/day, for determination of
              chronic dietary risk, based on a human study (MRID 00036510)
              having a LOEL of 1.8 mg/kg/day and an uncertainty factor of
              100.

              Ethephon has been reviewed by the Joint Meeting of the
       FAO/WHO on Pesticide Residue (JMPR). An acceptable daily intake
       (ADI) of 0.05 mg/kg/day was established by the JMPR in 1993. The
       ADI was based on the 16-day oral human study at a single dose level
       (0.5 mg/kg/day)  and a safety factor of 10.

       k.     Other Adverse Effects

              As of August 18, 1994, the following ethephon poisoning data
       were available:

              - The Pesticide Incident Monitoring System (PIMS) reported
              four cases of skin injury (irritation) in California as a result of
              exposure to field residues.

              - California Department of Food and Agriculture reported one
              possible systemic case as a result of exposure to ethephon during
              1982-89.

              - Reports from The National Pesticide Telecommunication
              Network indicate that 29 calls were made between  1984-1991.
              Incidents that appear to be directly related to ethephon exposure
              include observations of eye and skin irritation from pesticide
              misuse. Several reported incidents involve exposure to a mixture
              of chemicals where it is unclear which chemical caused the
              adverse effects.

              - The  EPA Incident Data System (June, 1992 to July, 1994)
              contains no worker related reports for ethephon.

2.     Exposure Assessment

       a.      Dietary Exposure

             Tolerances for residues of ethephon in or on food/feed
       commodities are currently expressed in terms of ethephon per se
       [40 CFR §180.300 (a) and (b), §185.2700 (a), (b), and (c), §186.2700
       (a)].  Adequate enforcement methods are available for the  determination
                             14

-------
 of residues of ethephon per se in/on plant commodities and in milk and
 ruminant tissues.

        The Ethephon Registration Standard required analysis of certain
 food/feed crops for residues of monochloroacetic acid (MCAA), a
 theoretical degradation product of an impurity in technical ethephon.
 Because submitted data indicated that apparent MCAA residues present
 in treated samples of a broad range of food/feed commodities were
 generally at or below the validated 0.01 ppm detection limit, the
 EPA/OPP/HED Metabolism Committee determined that MCAA need
 not be included in the tolerance expression or further considered as a
 component of dietary risk assessments for ethephon.

        Plant Metabolism

        The qualitative nature of the residue in plants is adequately
 understood based on tomato, cantaloupe, apple, fig, pineapple, tobacco,
 grape, walnut, filbert, cherry, tangerine, and lemon metabolism data.
 Ethephon degrades to ethylene, phosphate, and chloride. Data indicate
 that proximal and distal translocation of ethephon to fruits may occur
 following application to leaves.  The residue of concern in plants is
 ethephon per se.  (MRID numbers are listed in Appendix B under
 Guideline 171-4 A).

       Animal Metabolism

       The qualitative nature of the residue in ruminants is adequately
 understood based on goat metabolism data. In ruminant tissues and
 milk, ethephon is incorporated into natural products (glutathione
 conjugates,  protein, glycogen, triglycerides) and expired as CO2 and
 ethylene. No residues of ethephon were detected in the goat metabolism
 study; however, residues of ethephon were detected in ruminant tissues
 and milk in a ruminant feeding study which was conducted at
 exaggerated dosing levels.  The residue of concern in milk and ruminant
 tissues is ethephon per se. (MRID numbers are listed in Appendix B
 under Guideline 171-4B).

       The qualitative nature of the residue in poultry is not adequately
defined. A poultry metabolism study was submitted and deemed
inadequate to describe the nature of the residue in poultry tissues and
eggs due to  inadequate characterization of organic extractable residues,
inadequate storage stability information, and inadequate storage stability
data to support the poultry metabolism study. Data indicate that
radioactive residues are transferred to poultry muscle, fat, kidney, liver,
                       15

-------
egg yolks and egg whites (0.023 ppm to 0.459 ppm ethephon
equivalents) resulting from the consumption of [14C]ethephon (five
consecutive doses at a rate equivalent to 53 ppm). A new poultry
metabolism study is required and is in progress.  (MRID numbers are
listed in Appendix B under Guideline 171-4B).

       Tolerances for residues of ethephon are not currently established
in poultry tissues and eggs.  Until the nature of the residue is adequately
delineated in poultry tissues and eggs, the total radioactive residue
(TRR) levels in poultry tissues and eggs as determined from available
poultry metabolism data will be used to estimate the  residue levels for
acute and chronic dietary risk estimates. The estimated residue levels in
poultry are  as follows:

       poultry liver         0.015 ppm
       poultry kidney       0.010 ppm
       Poultry muscle       0.001 ppm
       Poultry fat           0.008 ppm
       Eggs                0.025 ppm
       Residue Analytical Methods - Plants and Animals

       Adequate methods for purposes of enforcement of ethephon
tolerances in plant commodities, ruminant tissues and milk are available.
The Amchem-Plant Method (PAM, VOL. II, Method I) is the
recommended method for enforcement purposes for plant commodities
and processed products other than wheat and barley straw.  The
Amchem-Cereal Method (forwarded to FDA for inclusion in the PAM,
VOL. n, Method n) is  the recommended method for enforcement
purposes for wheat and barley straw.  The Union Carbide-Animal
Method (forwarded to FDA for inclusion in the PAM, VOL. n,  Method
HI) is the recommended method for enforcement purposes for milk and
animal tissues. [Note:  Since the nature of the residue in poultry  has not
been adequately defined, the adequacy of the available analytical
methods for poultry products cannot be determined.] (MRID numbers
are listed in Appendix B under Guideline 171-4C/D).

       The plant and animal analytical methods currently recommended
for enforcement purposes employ diazomethane as a methylating agent
and the Agency (in the  1991 Registration Update) required the registrant
to revise the currently accepted enforcement methods to replace
diazomethane with a safer methylating agent or provide documentation
supporting the need for diazomethane  if a suitable alternative
                      16

-------
 methylating agent is impractical. Rather than address Agency concerns
 about the use of diazomethane as a methylating agent, the registrant has
 submitted new plant and animal methods for enforcement purposes
 which principally involve the decomposition of ethephon to ethylene to
 determine the residues of ethephon in/on apples, barley grain, barley
 straw, blackberries, cantaloupes, cherries, cottonseed,  cucumbers,
 grapes, macadamia nuts, peppers, pineapples, tobacco, tomatoes,
 sugarcane, walnuts, wheat grain, wheat straw, meat, milk and eggs.
 The Agency reviewed the new proposed plant and animal enforcement
 methods and concluded that in order for the proposed methods to be
 considered adequate for enforcement purposes,  they must undergo a
 successful independent laboratory validation (ILV) as described in PR
 Notice 88-5 (7/15/88) followed by a successful  method validation by the
 Agency.

       The  FDA Pestdata (PAM Vol. I Appendix, 8/93) indicates that
 ethephon is  not recovered through any of the  Multiresidue Protocols.

       Additional confirmatory data are required to satisfy plant and
 animal residue analytical methods data requirements. The registrant
 must either revise the currently accepted enforcement methods to replace
 diazomethane with a safer methylating agent or  provide documentation
 supporting the need for  diazomethane in the currently accepted
 enforcement methods if a suitable alternative methylating agent is
 impractical or submit independent laboratory  validation (ILV) for the
 proposed ethylene release methods. The registrant is required to
 radiovalidate the preferred animal enforcement method using samples
 from the new poultry metabolism study which is in progress.

       Storage Stability

       Adequate storage stability data are available for  apples, barley
 grain and straw, blackberries, cherries, cottonseed, grapes, macadamia
 nuts,  peppers, pineapples, tobacco, tomatoes, walnuts, and wheat grain
 and straw. Storage stability data indicate that residues of ethephon are
 generally stable for intervals of up to 24 months in frozen commodities.
 Ethephon residues are also stable in freeze-dried cherries, pineapple,
 apples, grapes, tomatoes, and blackberries for up to 24  months stored at
 room temperature.  Since the registrant has committed to conduct new
pepper and cantaloupe field trials, no additional  storage stability data are
 required to support previously submitted pepper and cantaloupe
magnitude of the residue data.  Additional information regarding storage
intervals  of sugarcane test samples from previously submitted sugarcane
                       17

-------
field trial studies remains outstanding. (MRID numbers are listed in
Appendix B under Guideline 171-4E).

       The registrant has committed to generate storage stability data on
processed samples of cottonseed oil and apple juice to support available
magnitude of the residue data for processed raw agricultural
commodities.  The registrant must provide an adequate description of the
storage intervals and conditions of grape processed commodity samples
from processing studies used to determine the potential for concentration
of ethephon residues in grape juice, raisins, raisin waste, dried grape
pomace,  and wet grape pomace. These data are considered
confirmatory.

       Since the registrant has committed  to conduct a new sugarcane
processing study, no additional storage stability data are required to
support previously submitted sugarcane processing data.

       Available storage stability data adequately demonstrate that
residues of ethephon are stable in meat, milk, and eggs for up to 12
months, 4 months, and 15 months, respectively, when samples are
stored  in polypropylene bottles at approximately -20°C.  Since the
Agency has  required new animal feeding studies, no additional storage
stability data are required to support previously submitted animal feeding
studies.

       All future plant and animal  magnitude of the residue studies must
have supporting storage stability data.  The Agency prefers that
concurrent storage stability studies be conducted.

       Magnitude of the Residue in Plants

       All magnitude of the residue data requirements are satisfied for
the raw agricultural commodities apples, barley grain and straw,
blackberries, cherries, macadamia  nuts, pineapples, sugarcane,
tomatoes, walnuts, and wheat grain and straw.  Field trials were
performed representing the various conditions under which the pesticide
can be applied. Geographical representation is adequate and a sufficient
number of trials reflecting representative formulation classes were
conducted.  In addition, magnitude of the residue and pyrolysis studies
have been submitted for tobacco. (MRID numbers are listed in Appendix
B under Guideline 171-4K).

       Assuming that the registrant adequately amends the 0.33 Ib/gal
SC/L label (EPA Reg. No. 264-263) to prohibit the harvesting of any
                       18

-------
 treated pumpkins for human or animal consumption and specify that
 treatments are to be made to pumpkins for seed production only, no
 additional cucumber, squash, or pumpkin residue data are required since
 the Agency considers these non-food uses. Currently established
 tolerances for cucumbers and pumpkins should be revoked.

        Assuming that all pertinent product labels are amended to reflect
 a maximum allowable use rate of 2 lb/A/season for application of
 ethephon to cotton and the registrant amends the established tolerance
 for residues of ethephon in/on cottonseed from 2 ppm to 4 ppm, no
 additional cottonseed residue data are required.

        New residue field trials are required by the Agency for
 cantaloupes,  grapes, and peppers and are in progress.  To supplement
 available grape field trial data, the registrant  has agreed to conduct
 additional trials in California. The registrant has also committed to
 conduct repeat cantaloupe and pepper field trials that are required due to
 stability problems encountered in earlier studies.  These data are
 considered confirmatory.

       The Agency currently  recognizes cotton gin byproducts and
 aspirated wheat grain fractions as raw agricultural commodities and has
 determined that label restrictions  for barley forage, barley hay, wheat
 forage, and wheat hay are not appropriate (Pesticide Assessment
 Guidelines, Subdivision O, Residue Chemistry, TABLE H (June 1994)).
 Data depicting residues of ethephon in/on cotton gin byproducts, wheat
 forage, and wheat hay resulting from maximum registered use rates are
 hereby required.  A minimum of six (6) field trials for cotton gin
 byproducts and twenty (20)  field trials for wheat forage and hay are
 required. For additional guidance on sampling and geographical
 locations for field trials the registrant should consult "EPA Guidance on
 Number and Location of Domestic Crop Field Trials for Establishment
 of Pesticide Residue Tolerances" issued 6/2/94.  Data on wheat forage
 and hay will be translated to barley forage and hay, respectively. Wheat
 grain dust data were previously submitted  which indicated that residues
 of ethephon do not concentrate in aspirated wheat grain fractions. In
 accordance with guidance (issued June 2, 1994) on aspirated grain
 fractions (grain dust), additional aspirated  wheat grain fractions data are
 not required and no tolerance is needed for residues of ethephon in/on
 aspirated wheat grain fractions.

       Ethephon residue data requirements for cotton gin byproducts
and wheat forage  and hay which result from changes in the Livestock
Feeds Table (Pesticide Assessment Guidelines, Subdivision O, Residue
                       19

-------
Chemistry, TABLE n (June 1994)) will be imposed at the issuance of
this document but should not impinge on the reregistration eligibility
decision for ethephon. The need for additional tolerances and revisions
to exposure/risk assessments will be made upon receipt of required data.

       Magnitude of the Residue in Processed Food/Feed

       Processing studies have been conducted on apples, barley,
cottonseeds, grapes, pineapples, tomatoes, and wheat and, pending the
receipt of adequate storage stability data, are deemed adequate to
determine the extent to which residues of ethephon concentrate in
food/feed items upon  processing of the raw agricultural commodity.
(MRID numbers are listed in Appendix B under Guideline 171-4L).

       Data indicate that ethephon residues concentrate in apple juice,
dried apple pomace, barley hulls, cottonseed meal, grape juice, raisins,
raisin waste, dried grape pomace, pineapple bran and pulp, dried tomato
pomace, wheat bran, wheat shorts and germ and red dog.

       The registrant  has committed to generate new sugarcane
processing data.  These data are considered confirmatory.

       The Agency no longer considers dried apple pomace a feed item
(Pesticide Assessment Guidelines, Subdivision O, Residue Chemistry,
TABLE n (June 1994)).  Available apple processing data indicate that
residues of ethephon do not concentrate in  wet apple pomace.
Therefore, a feed additive tolerance on apple pomace is not required.
Pending the  receipt of adequate storage stability data, no additional apple
processing data are required.

       The Agency currently considers tomato paste a processed food
(Pesticide Assessment Guidelines, Subdivision O, Residue Chemistry,
TABLE n (June 1994)).  Available tomato processing data indicate that
residues of ethephon do not concentrate in  tomato paste and, therefore,
no tolerance is needed.  Pending the receipt of adequate storage stability
data, no additional tomato paste residue data are required.

       The Agency no longer considers pineapple bran a processed
commodity of pineapples, but now considers pineapple juice and the wet
waste byproduct from fresh-cut product line,  referred to as pineapple
process residue, as the processed commodities of pineapples (Pesticide
Assessment Guidelines, Subdivision O, Residue Chemistry, TABLE n
(June 1994)).  Pineapple processing data indicate that residues of
ethephon concentrate in dried pineapple bran (5.3x) and wet pulp (1.2x)
                      20

-------
 but do not concentrate in juice, syrup, and slices.  Based on these data
 which demonstrate that there is no significant concentration of residues
 of ethephon in pineapple wet pulp (1.2x), the Agency concludes that no
 feed additive tolerance for residues of ethephon in pineapple process
 residue is required.  Pending the receipt of adequate storage stability
 data, no additional pineapple processing data are required.

       Magnitude of the Residue in Meat, Milk, Poultry, and Eggs

       Tolerances exist for milk and fat, meat, and meat byproducts of
 cattle, goats, hogs, horses, and sheep. Tolerances for residues of
 ethephon in poultry tissues or eggs have not been established.  The 1988
 Ethephon Guidance Document deferred evaluation of the available
 ruminant and poultry feeding studies. These previously submitted
 feeding studies have been evaluated and are deemed inadequate.  New
 ruminant and poultry feeding studies must be conducted at Ix, 3x, and
 lOx the maximum theoretical dietary burden in order to refine current
 dietary exposure estimates, adequately reassess the currently established
 ruminant tissue and milk tolerances, and determine the appropriate
 tolerances for poultry tissues and eggs.  These data are considered
 confirmatory.  (MRID numbers are listed in Appendix B under
 Guideline 171-4J).

       Until these data are generated, the existing ruminant feeding
 study and poultry metabolism data will be used in exposure/risk
 assessments.

       Confined Rotational Crops

       A confined rotational crop study (MRID 43143601) is currently
 in review.

       Field Rotational Crops

       The requirement for field rotational crop studies will be
 determined after the confined rotational crop study has been evaluated.

 b.     Occupational and Residential

 Handler (Mixers, Loaders, Applicators, etc.) Exposure

       The Agency has determined that there is an exposure potential
 for mixers, loaders, applicators, and or other handlers during the usual
use-patterns associated with ethephon. The mixing, loading, and
                      21

-------
       application methods include open pouring, broadcast (aerial and ground)
       application and application with hand-held equipment.

              Exposure data requirements are triggered based on the potential
       for exposure and the lexicological significance of the active ingredient.
       Since there is no indication that ethephon is absorbed by the dermal
       route based on the lack of systemic effects noted, ethephon meets the
       exposure criteria, but not the toxicity criteria.  Therefore, exposure data
       for occupational and residential activity patterns (M/L/A) associated
       with the use of ethephon are not required for reregistration eligibility.
       Similarly, an exposure assessment is not required.

       Post-Application Exposure

              The Agency has determined that there is an exposure potential
       for persons entering treated sites after the application is completed.
       These potential exposures  exist for persons after applications  to crops
       such as tobacco, grapes, apples,  peppers, blackberries, cantaloupes, and
       ornamentals.  Because there are no toxicological endpoints of concern
       for dermal (systemic) toxicity, neither exposure data nor an exposure
       analysis are required for reregistration eligibility.

              The Agency has determined that based on concerns  regarding
       potential eye and skin irritation,  a 48 hour restricted-entry interval (REI)
       as imposed by the Worker Protection Standard (WPS) will  be retained.
       Further, the Agency has determined that this 48-hour REI must be
       increased to 72 hours when ethephon is applied outdoors in arid areas.
       (Refer to Section IV, B, 4 for discussions of labeling rationale and uses
       within scope of the WPS. Refer to Section V for labeling requirements).

3.     Risk Assessment

              In order to adequately determine the risk associated with a
       chemical the toxicological  end-points of concern must be identified in
       relation to the potential route(s), duration and/or frequency of the
       exposure(s). The toxicological endpoints of significance for dietary and
       occupational exposure are  as follows:

              1)  The acute (one day) dietary endpoint is based on cholinergic
              signs in humans at  1.8 mg/kg/day and a margin of exposure
              (MOE) of less than 10 will generally indicate a risk concern.

              2)  There are no toxicological endpoints  of concern associated
              with short term (one to seven days) or intermediate term (1 week
                             22

-------
        to several months) occupational or residential exposure because
        there was no evidence of (systemic) toxicity by the dermal route.

        3) There is no cancer concern associated with this chemical.
        Ethephon is classified as a Group D chemical based on the
        "insufficiency of the weight of evidence".

        4) The reference dose (RfD) is 0.018 mg/kg bwt/day, for
        determination of the chronic dietary risk, based on a human study
        (MRID 00036510) having a LOEL of 1.8 mg/kg/day and an
        uncertainty factor of 100.

 a.      Dietary

        Food uses evaluated in this analysis were the published food uses
 listed in 40 CFR 180.300, food additive tolerances listed in 185.2700,
 an increase in tolerance for cottonseed from 2 ppm to 4 ppm
 recommended in the Tolerance Reassessment Summary, a proposed food
 additive tolerance of 10 ppm for residues of ethephon in apple juice, and
 estimated residues in poultry and eggs (see dietary exposure above).
 The following uses were recommended for revocation in  the Tolerance
 Reassessment Summary:

       blueberries
       coffee beans
       cranberries
       cucumbers
       figs
       filberts
       guavas
       lemons
       pumpkins
       tangerines and tangerine hybrids

       Dietary  risk was calculated both with and without  these uses,
based on the assumption that until tolerances are revoked, import use of
a pesticide could  still occur on these sites.

       Residue data required  to ascertain the adequacy of the established
tolerances for cantaloupes, grapes, peppers, milk, and the fat, meat, and
meat byproducts of cattle, goats,  hogs, horses, and sheep  were deemed
unacceptable for reassessment purposes. In the absence of reassessed
tolerances for these crops existing tolerances were used in the analysis.
This could result  in overestimation or underestimation of risk if
                      23

-------
 acceptable studies suggest adjustment of the existing tolerances to be
 appropriate.

       Though a reassessed tolerance for grapes was not possible at this
 time, available processing data which indicate that ethephon does
 concentrate in "grape juice" was considered.  The existing tolerance of
 2 ppm on grapes was multiplied by the supplied concentration factor of
 4X to get a derived high end residue of 8 ppm for grape juice which was
 also applied to the food item "wine and sherry" in the analysis.

       Percent of crop treated (PCT) values used in the chronic
 exposure analysis can be found in Section EC, of this document.  The
 percent crop treated information was provided as ranges of values for
 the commodities.  The high end of the range was used for the analysis.
 Though percent of crop treated values were not specifically given for
 blackberries or sugarcane, it was noted that no recent usage of ethephon
 on these crops was found.  Rather than assume the default that 100
 percent of these crops are treated, 1 % was used in the analysis.   Percent
 of crop treated information was not supplied for many of the crops
 recommended for revocation. The default value of 100 percent crop
 treated was assumed for these crops, with the result being probable
 overestimation of exposure and risk in the chronic analysis that included
 tolerances recommended for revocation.

       Though no tolerances have been established for poultry meat and
 eggs, estimates of residue levels were used in analyses until additional
 required poultry metabolism and feeding studies are received and the
 need for tolerances is determined.  These estimated residues are based
 on the current maximum poultry dietary exposure estimate in  relation to
 the total  radioactive residue (TRR) levels demonstrated in available
 poultry metabolism data. The estimated residues were used in both the
 acute and chronic analyses.  Tolerance level residues were assumed in
 the acute exposure analysis.

       The chronic dietary exposure analysis used tolerance level
 residues  and 100 percent crop treated to estimate the Theoretical
 Maximum Residue Contribution (TMRC) for the overall U.S.
 population and 22 population subgroups.  Anticipated residues and
 refined percent of crop treated data were used to calculate the
 Anticipated Residue Contribution (ARC) for those same population
 groups.   The ARC is considered the more  accurate estimate of dietary
exposure. These exposure estimates were then compared to the  RfD for
ethephon to derive estimates of  chronic dietary risk. Two analyses were
performed: the first assessing exposure and risk from all uses  for which
                       24

-------
 tolerances either exist, have been recommended in the Tolerance
 Reassessment Summary in this document, or have been proposed; and
 the second excluding those uses for which revocation was recommended
 in the Tolerance Reassessment Summary.

       When all published tolerances are considered, the ARC for the
 overall U.S. population is 0.001572 mg/kg bwt/day, which represents
 8.7%  of the RfD.  When residues in poultry and eggs, the recommended
 increase in the tolerance on cottonseed, and the proposed tolerance for
 "apple juice" are considered, the ARC is raised to 0.001624 mg/kg
 bwt/day, or 9.0% of the RfD.  The ARC for the subgroup most highly
 exposed, non-nursing infants less than one year old, is 0.008227 mg/kg
 bwt/day (46% of the RfD) from published tolerances and 0.008781
 mg/kg bwt/day (49% of the  RfD) from published, proposed and
 recommended uses.

       When tolerances recommended for revocation are excluded from
 the analysis, the ARC for the U.S.  population from all uses
 recommended through reregistration (including poultry and eggs, the
 increased tolerance on cottonseed and the proposed tolerance for "apple
 juice") is 0.001553 mg/kg bwt/day, or 8.6% of the RfD. Non-nursing
 infants less than one year have an ARC of 0.008427 mg/kg bwt/day, or
 47% of the RfD.

       Given the estimates arrived at in these analyses, it appears that
 chronic dietary risk from food uses of ethephon recommended through
 reregistration is not of concern.  The proposed tolerance of 10 ppm for
 apple juice does  not appear to present a chronic risk of concern.

       A detailed acute dietary exposure analysis was performed in
 which  all food uses and food uses recommended  for revocation in the
 Tolerance Reassessment summary were included at tolerance levels.
 The analysis evaluated individual food consumption as reported by
 respondents in the USD A 1977-78 Nationwide Food Consumption
 Survey (NFCS) and estimated the distribution of single day exposures
 through the diet for the U.S.  population and certain subgroups.  The
 analysis assumed uniform high-end  (at tolerance) residues of ethephon in
 the commodity supply.  Because cholinesterase inhibition (neurotoxicity)
 is the endpoint of concern, exposure and risk were calculated for all
 standard population subgroups.

       The Margin of Exposure (MOE) is a measure of how closely
estimated exposure comes to  the dose of concern (usually a NOEL), in
this case a LOEL of 1.8 mg/kg/day. In the analysis the MOE was '

                      25

-------
calculated as the ratio of the LOEL to the exposure (LOEL/exposure =
MOE).

       MOEs were calculated using an estimate of the 95th percentile of
exposure for five of the population subgroups (U.S. population- 48
states, Infants < 1 year, Children ages  1 through 6 years, Females
(13-1- years), and Males (13+ years).  "Infants <  1 year" are the only
population subgroup that appears to be a concern,  with 5% of the
population estimated to have MOEs of less than 7.  However, the
Agency believes this risk estimate represents an unrealistic worst case
situation because the following conservative assumptions were employed
in calculating exposure:

       1. The Agency assumed that all food crops on which ethephon is
       registered have been treated with ethephon  and that maximum
       residue levels reported in or on unwashed,  unpeeled, uncooked
       commodities at the farm gate are present on all foods.  However
       usage data  indicate that the treatment percentage of major infant
       foods on which ethephon is registered is < 10% or even
       "negligible".

       2. The probable residue dilution that occurs in processed infant
       foods was not taken into account.

       3. Ethephon degrades  fairly rapidly to ethylene, phosphate and
       chloride  in neutral and alkaline environments.  Therefore, by the
       time the  food has cleared distribution channels and/or processing
       plants, residues at the dinner table are likely to be significantly
       lower than  high-end levels  at the farm gate.

       For the reasons stated above the Agency believes it is unlikely
that infants  will be exposed to ethephon treated commodities at levels
that will  result in acute dietary risk.

b.     Occupational and Residential

       There is  a potential for mixer/loader/applicator (handlers)
exposure and post-application exposure via the inhalation and dermal
route;  however, there are no toxicological endpoints of concern
regarding dermal (systemic) toxicity, inhalation toxicity  or other adverse
effects. There is a potential for eye and skin irritation from  surface or
spray contact for post-application workers; therefore, a 48-hour
restricted entry interval is required following applications of ethephon to
reduce the risk of irritation.  Based on the lack of toxicological
                       26

-------
             concerns, the risk posed by this chemical is considered minimal for
             occupational/residential workers/users. Labeling and personal protective
             equipment requirements are discussed in Sections IV and V.
C.     Environmental Assessment

       1.     Environmental Fate

             The environmental fate database for ethephon is adequate for
       reregistration purposes. Although the aged leaching data requirement was
       waived by the Agency in April  1990, recent information has documented an
       additional degradate, which was not known at the time the waiver was granted.
       A batch equilibrium study with  2-hydroxy ethyl phosphonic acid is needed in
       order to determine the mobility of this major, persistent degradate.  Although it
       appears from the photodegradation on soil, aerobic soil metabolism, and
       anaerobic aquatic metabolism studies, that this degradate may be bound  to soil,
       Freundlich adsorption and desorption values (Kads and K^) are needed to
       confirm the reregistration eligibility of ethephon. This  information is not
       expected to change the overall environmental fate and transport assessment of
       ethephon.

             Because ethephon may induce modifications in plant growth, the Spray
       Drift data requirements were imposed in order to assess the extent of exposure
       of nearby non-target plants to ethephon. These studies are being held in reserve
       pending the work currently being  conducted by industry's Spray Drift Task
       Force.

             a.      Environmental Chemistry, Fate and Transport

             Detailed information regarding the fate of ethephon  in the environment
       is provided below.  Environmental fate studies used to support the reregistration
       of ethephon are given in Appendix B.

       Hydrolysis

             Ethephon is stable to hydrolysis in acidic sterilized water, but does
       rapidly hydrolyze in neutral and alkaline environments.  Ethephon was stable
       towards hydrolytic degradation in  a sterile pH 5 buffered solution incubated in
       the dark at 25 ± 1 °C for 30 days, and has a calculated half-life of
       approximately 73 days.  However, under neutral and basic conditions, rapid
      degradation was observed, with  approximate half-lives of 2.4 days and 1.0 day
       for pH 7 and  pH 9, respectively.  Ethylene gas was the only labeled degradate
                                   27

-------
detected under all three pH conditions. In addition to ethylene, phosphoric acid
was also found (MRID 41545701).

Photodegradation in water

       Ethephon is stable to photolysis in water.  Ethephon was stable towards
photodegradation in a sterile pH 5 aqueous buffered solution exposed to
continuous artificial sunlight for 15 days at 25 ± 1°C.  Ethylene gas was the
only radiolabeled degradate, however, phosphoric acid was also identified in
solution. These two degradates were also identified in the dark controls and are
attributed to hydrolysis.  There were no distinctive photolytic products formed.
The half-life under irradiated conditions was calculated to be 61 days.  Under
the non-irradiated control conditions, the half-life was 111 days.  If it is
assumed that hydrolysis occurs concurrently to the  same degree under irradiated
conditions, then a "photodegradation-only" half-life can be determined to be
139 days.  (MRID 41545601).

Photodegradation on soil

       Photodegradation on soil does not appear  to be a significant route of
dissipation of ethephon.  Ethephon degraded with a half-life of 5.1 days on
sandy loam soil that was irradiated with an artificial light source on a 12-hour
photoperiod for 30 days.  Ethephon  degraded with  a half-life of 8.0 days in the
dark controls.  Based on the calculated rate constants, photodegradation
accounted for approximately 36% of the total degradation observed over a given
24-hour period.  Other degradative processes accounted for the additional 64%.
The major  degradates were ethylene gas and soil-bound 2-hydroxy ethyl
phosphonic acid.  2-Hydroxy ethyl phosphonic acid appeared to be persistent;
its concentration increasing throughout the study  period. Both degradates were
found in the irradiated and dark control systems.  (MRID 41681401).

Aerobic soil metabolism

       Ethephon degrades fairly rapidly to ethylene gas and 2-hydroxy ethyl
phosphonic acid in soil under aerobic conditions.   Ethephon degraded with a
half-life of 7.5 days in aerobic sandy loam soil that was incubated in the dark at
25°C.  The major degradates were ethylene gas and soil-bound 2-hydroxy ethyl
phosphonic acid.  2-Hydroxy ethyl phosphonic acid appeared to be persistent;
its concentration increasing throughout the study  period. 14C Ethephon
comprised an average of 4.7% of the applied radioactivity after 30 days.  Two
radiolabeled degradates were isolated.  Ethylene gas was a maximum average of
15.0% of the applied at 21 days and was 8.5% at 30 days posttreatment.  The
nonvolatile degradate, 2-hydroxy ethyl phosphonic  acid, increased throughout
                             28

-------
 the study period to a maximum average of 63.5% of the applied at 30 days
 posttreatment.(MRID 41757701).

 Anaerobic aquatic metabolism

       Ethephon degrades fairly  rapidly to ethylene gas and 2-hydroxy ethyl
 phosphonic acid in flooded sediment under anaerobic conditions.  Ethephon
 degraded with a half-life of 5.3 days in flooded silt loam sediment that was
 incubated in the dark under a nitrogen atmosphere at 25 °C.  The major
 degradates were ethylene gas and soil-bound 2-hydroxy ethyl phosphonic acid.
 2-Hydroxy ethyl phosphonic acid appeared to be persistent; its concentration
 increasing throughout the study period. In the sediment/pond water system,
 approximately 1.8% of 14C ethephon was detected at 30 days postapplication.
 It was found that the radioactivity in the water layer was almost entirely due to
 parent ethephon.  Two radiolabeled degradates were isolated in the
 sediment/pond water system.  Ethylene gas averaged 27.2% of the applied at
 1 day posttreatment, 41.6% at 3 days, and 50.6-52.1% at days 14 through 30.
 The nonvolatile degradate,  2-hydroxy ethyl phosphonic acid, increased
 throughout the study period to a maximum average of 42.6% of the applied at
 30 days. (MRID 41757702).

 Leaching and adsorption/desorption

       Ethephon can be characterized as having moderate to low mobility in
 soil. Based on batch equilibrium experiments, 14C-ethephon in solution at 0.4,
 1.3, 5.1, and 10.1 ppm can be characterized as having moderate to low
 mobility in loamy sand and silt loam soil, and as being immobile in sandy loam
 and clay soil and in  sandy loam pond sediments that were equilibrated in the
dark for 24 hours at 25°C.  Freundlich adsorption values  (Kads) were 2.4 for the
 silt loam soil, 7.2 for the loamy sand soil, 29.8 for sandy loam soil, 53.1 for
the clay soil, and 57.3 for the sandy loam pond sediment. Respective K^. values
were 608, 3117, 4078, 3220,  and 1676. Freundlich desorption values (Kde$)
were 3.9 for the silt loam soil, 17.5 for the loamy sand soil, 62.4 for sandy
loam soil, 69.0 for the clay soil, and 87.9  for the sandy loam pond sediment;
respective K^ values were 992, 7600, 8547, 4181, and 2570
(MRID 42126001).
                            29

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 Terrestrial field dissipation

        Ethephon dissipates fairly rapidly and shows moderate to low mobility
 under actual field conditions.  At field sites in southern California, North
 Carolina, and Washington, ethephon (2-6 Ib/gallon soluble concentrate
 (SC)/1), at 1.6-2 Ib ai/A, dissipated with half-lives of approximately 7-25 days.
 Although ethephon was detected at depths of 45 and 60 cm in the loam soil in
 California and the loamy sand soil in Washington, respectively, these detections
 were likely the result of sample contamination through the use of the bucket
 auger sampling apparatus,  given that these detects were first encountered within
 1 week after application.  In North Carolina sand soil, ethephon did not move
 below the  15-cm depth .

       In California, ethephon dissipated with a calculated half-life of
 11.7 days in the O-to-45 cm depth of loam soil after spraying with ethephon
 (Ethrel,  2 Ib/gallon SC/L)  at a  nominal concentration of 1.6 Ib ai/A (maximum
 label rate).  At the time of application (May 1990), the field plot contained
 tomato plants that were 10-30 cm in height.  In the O-to-15 cm soil depth,
 ethephon concentrations ranged from 0.62-0.87 ppm immediately posttreatment,
 0.31-0.39 ppm at 4 days, 0.13-0.19 ppm at 15 days,  0.06-0.08 ppm at 29 days,
 and 0.02 ppm at 98 days.   In the 15-to-30 cm soil depth, ethephon averaged
 0.026 ppm at 4 and 9 days posttreatment and ^0.01 ppm at 15 through 98 days.
 Ethephon was detected in the 30-to-45 cm depth only at 4 and 9 days
 posttreatment, at 0.010-0.020 ppm. Ethephon was not detected below a depth
 of 45 cm.

       In North Carolina, ethephon dissipated with a calculated half-life of
 6.8 days in the O-to-15 cm  depth of sand soil that was sprayed with ethephon
 (Prep, 6 Ib/gallon SC/L) at a nominal concentration of 2 Ib ai/A (maximum
 label rate).  At the time of application (August 1990), the field plot contained
 cotton plants that had been  trimmed to 0.2 m in height. In the O-to-15 cm soil
 depth, ethephon was detected at 0.72-1.29 ppm immediately posttreatment,
 0.35-0.41 ppm at 4 days, 0.06-0.11 ppm at 16 days, and 0.03-0.05 ppm at
 31 days. Ethephon was not detected below a depth of 15 cm.

       In Washington State, ethephon dissipated with a calculated half-life of
 25.0 days in the O-to-60 cm depth of loamy sand soil that was sprayed with
 ethephon (Cerone, 4 Ib/gallon SC/L) at a nominal concentration of 1.66 Ib ai/A
 (> 3x maximum label rate).  At the time of application (April 1990), the field
 plot contained wheat plants that were 0.5-0.7 cm in height.  In the O-to-15 cm
 soil depth, ethephon was detected at 1.18-1.34 ppm immediately posttreatment,
0.14-0.31 ppm at 7 days, 0.10-0.21 ppm at 30 days, and 0.01-0.04 ppm at
58 through 128 days.  In the 15-to-30 cm soil depth, ethephon averaged
0.30 ppm at 7 days posttreatment and steadily decreased to 0.01 ppm at

                             30

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 128 days.  Ethephon averaged a maximum 0.205 ppm in the 30-to-45 cm depth
 and 0.06 ppm in the 45-to-60 cm depths; both maximum concentrations were
 measured at 7 days posttreatment. (MRID 42011501)

       b.     Environmental Fate Assessment

       Ethephon is not persistent in the environment.  The major routes of
 dissipation appear to be chemical hydrolysis under neutral and alkaline
 conditions and microbial degradation.  Although ethephon does degrade fairly
 rapidly in somewhat acidic soils (pH 6.1) under aerobic and anaerobic
 conditions, it does not hydrolyze in sterile, acidic  water (pH 5). The major
 degradates of ethephon are ethylene gas and 2-hydroxy ethyl phosphonic acid,
 the latter formed by microbially mediated hydrolytic dehalogenation.  Ethephon
 can be characterized as having moderate to low  mobility in soil. The mobility
 of the soil degradate 2-hydroxy ethyl phosphonic acid is not conclusively
 known, however, it is believed that it binds to soil.

       Ethephon is reported to have a very low  octanol/water partition
 coefficient ( Kow<0.00626), therefore, it is not expected to accumulate in fish.

       In the field, ethephon exhibited the same characteristics  (rapid
 degradation and  moderate to low mobility) as  those seen in the laboratory.  At
 field sites in southern California, North Carolina,  and Washington, ethephon
 dissipated with half-lives of approximately 7 to 25 days.  Although ethephon
 was detected at depths of 45 and 60 cm in the loam soil in California and the
 loamy sand soil in Washington, respectively, these detections were likely the
 result of sample  contamination through the use of the bucket auger sampling
 apparatus, given that these detects were first encountered within 1  week after
 application.  In North Carolina sand soil, ethephon did not move below the
 15 cm depth.

2.     Ecological Effects

       All data requirements for assessing the ecological risk of ethephon have
been satisfied.
                             31

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a.     Ecological Effects Data

       (1)    Terrestrial Data

       Avian Acute Toxicity
•'.'-. /'V1 •'-". •• -,':' ,-Ai^rJteifl^E^ •/, - v '' ' ' "
Species
Bobwhite Quail
Bobwhite Quail
Mallard Duck
% Test Material
TGAI
75%
TGAI
IJJjo mg ai /kg
1072 mg/kg
596 mg/kg
1998 mg/kg
Conclusions .
slightly toxic
slightly toxic
slightly toxic to practically nontoxic
       Acute oral toxicity studies show that ethephon is slightly toxic to
bobwhite quail and slightly toxic to practically nontoxic to mallard duck.
(MRIDs 00026041, 00027493, 00026040).

       Avian Subacute Dietary Toxicity
„ , -Avian Subacute Dietary Toxicity Findings
Species
Bobwhite Quail
Mallard Duck
MallarH Hurt
% Test Material
21.3%
TGAI
7S<£
XiCjg ppm
> 10,000 ppm
> 10,000 ppm
-> ^nnn ppm
Conclusions
practically nontoxic
practically nontoxic
n,,^m 	 ,„
       On a subacute dietary basis, ethephon has been characterized as
practically nontoxic to mallard duck and bobwhite quail (MRIDs
00085446, 00122414, 00056480).

       Toxicity to Nontarget Mammals

             Acute oral toxicity studies in rats show that ethephon is
       slightly toxic to mammals with an LD50 of 1600 mg/kg. (MRTD
       00029509).
                      32

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                          (2)    Aquatic Data

                          Acute Fish Toxicil
Species
% Test Material
                                                     mg ai/1
                                  Conclusions
Bluegill sunfish, warm water
71.3%
                                                 221.7 me/1
                                                                  practically nontoxic
Fathead minnow, warm water
75%
                                                 88 mg/1
                                  slightly toxic
                         Ethephon was found to be practically nontoxic to coldwater fish
                  and practically nontoxic to slightly toxic to warmwater fish.
                  (MRIDs 00122412 and 00027496).

                         Acute Invertebrate Toxicity

Species
Daphnia magna
Daphnia magna
Chironomus teutons (midge)
Gamnwrus fasciatus (amphipod)
Aoite-lnTertebi^^TbxicityiFih^ngs
% Test Material
75%
TGAI
TGAI
TGAI
ECsa ppm
54 ppm
3 1.7 ppm
165 ppm
92.5 ppm
Conclusions



sli&htlv toxic
                         Ethephon has been found to be practically nontoxic to slightly
                  toxic to freshwater invertebrates. (MRIDs 00027496 and 00054013).

                         Chronic Invertebrate Toxicity

                         Based on data from an aquatic invertebrate life-cycle study with
                  Daphnia magna, the Maximum Allowable Tolerated Concentration
                  (MATC) was determined to be between 17 and 38 mg ai/1
                  (MRID 42294501)
                                        33

-------
       Estuarine/marine Toxicity
' . f ^ ~- " u ' <" .., - *, ',
' Estuai^/maiii^
Species
Oyster
Grass shrimp
% Test Material
72.2%
88.3%
Value mg ai/1
EC50 =60 mg ai/1
NOEL< 17 mg ai/1
LCift> 370 mg ai/1
Conclusions
slightly toxic
practically nontoxic
       There is sufficient information to characterize ethephon as
slightly toxic to estuarine/marine mollusks and practically nontoxic to
shrimp.  The requirement for testing acute toxicity with an
estuarine/marine fish has been waived. Of the species tested, the eastern
oyster is the most sensitive with effects on shell deposition being
observed at concentrations as low as  17 ppm. (MRIDs 41296202,
00054013 and 00027496).

       (3)     Non-Target Insects Data

              There is sufficient information to characterize ethephon as
       relatively nontoxic to honey bees.  The LD50 of technical
       ethephon is 7.0 /zg/bee. (MRID 00009181)

       (4)     Non-Target Plants Data

              The following table provides the results for the non-target
       plant testing.
                      34

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Study Type, Species
Seed Germination/Seedling
Emergence (Tiers 1 and 2)


Seedling Emergence (Tier 2)
Vegetative Vigor
(Tier 1 and 2)
Vegetative Vigor (Tier 2)
Aquatic Plant Growth and
Reproduction, Selenastrum
capricornutum
Aquatic Plant Growth and
Reproduction, Anabaena
flosaquae
Aquatic Plant Growth and
Reproduction, Navicula
pelliculosa
Aquatic Plant Growth and
Reproduction, Skeletonema
costatum
Aquatic Plant Growth and
Reproduction, Duckweed

^^^^^$0*
%Test
Material
•••^MM
71.9%



71.9%
71.9%
71.9%
71.9%

71.9%

71.9%

71.9%

71.9%

tcity to Non-Target Plants 	 	
Results
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^•^^^••^^^^•IIII^^H^^^^^^H
Seed Germination:
NOEL = 6.5 mg ai/1 (ryegrass)
Seedling Emergence:
NOEL = 5.5 mg ai/1 (all crops).
Shoot Length:
NOEL = 0.33 mg ai/1 (oat),
EC2S < 5.4 mg ai/1 (cabbage, lettuce, oat, soybean, and tomato)
NOEL = 0.23 Ib ai/A
ECK = 0.24 Ib ai/A
EC50 = 1.50 Ib ai/A (ryegrass)
NOEL = 0.29 Ib ai/A (corn)
NOEL = 0.49 Ib ai/A
ECzs = 0.79 Ib ai/A
EC50= 1. 80 Ib ai/A (carrot)
NOEL= 1.4mgai/l

NOEL = 1.8 mg ai/1

NOEL= 1.5mgai/l

NOEL = 1.8mgai/l

NOEL < 0.10 mg ai/1
EC,n = 2.5 mg ai/1
       The most significant effect of ethephon on terrestrial plants was a
reduction of plant growth resulting in reduced shoot lengths and weights.  For
emerging seedlings, ryegrass was the most sensitive species tested, with a 25%
reduction in shoot length occurring at an application rate of 0.24 Ibs ai/acre.
For mature plants, carrot was the most sensitive species tested, with a 25%
reduction in shoot weight occurring at an application rate of 0.49 Ib ai/acre.
Duckweed was the most sensitive aquatic plant species.  A 50% reduction in
                              35

-------
growth of duckweed occurs at a concentration of 2.5 mg ai/L. (MRIDs
41403301,41403302,41403303, 41403304,41403305, 41509001,41659401).

b. Ecological Effects Risk Assessment

This section consists of numerous risk assessments each covering
a different combination of endpoint and exposure scenarios. Each risk
assessment includes a risk quotient which combines the toxicity and
exposure information. For each risk quotient there is an established
value above which the risk is considered to be at a high level of concern
(LOG). The generic risk quotients and their respective LOC's for each
risk assessment are provided in the following table. Note that the same
risk quotients are used for non-endangered and endangered species, but
the acute LOG is lower for endangered species.
Established Levels of Concern (LOC's)
Endpoint/Scenario
Mammalian acute
Mammalian chronic
Avian acute
Avian chronic
Aquatic acute
Aquatic chronic
Nontarget insects and plants
Risk Quotient
EEC/LC™
EEC/LEL
EEC/LQn
EEC/LEL
EEC/LC™
EEC/LEL
Not quantified
LOC
Non-Endaagered
0.5
1.0
0.5
1.0
0.5
1.0
N/A
LOC
0.1
1.0
0.1
1.0
0.05
1.0
N/A
Non-Endangered Species

Terrestrial Organisms

Ethephon is expected to have minimal effects on birds. Minimal effects are also
expected for mammals.

The maximum residues that would be expected in animal forage are given in the
following table. Since 3 Ib/A is the maximum use rate for any use site, 720 ppm is the
maximum possible expected environmental concentration (EEC). This is over ten
times smaller than the LC50 for mallards (LC50 > 10,000 ppm) or 3 times smaller than
the LC50 for bobwhites (LC50 > 2130 ppm).
36

-------
Maximum Residues of Ethephon on Vegetation Immediately
Following Application (Hoerger and Kenaga, 1972)
Short grass
480
240
Long grass
330
220
110
Leaves and leafy crops
375
250
125
Forage Crops (legumes)
174
116
58
Pods with seeds (legumes)
36
24
12
Grain
30
20
10
Fruit
21
14
Aquatic Organisms

Freshwater Fish

Ground Application

Minimal impact on fish is expected from ground application of ethephon.

The following scenario is applicable to ground application on all crops except
peanuts, for which seed treatments are used. Since ethephon is highly soluble in water
(1.2 x 103 ppm), 5% of the amount applied is expected to enter the aquatic
environment in surface runoff. The maximum application rate is 3 Ib/A for foliar
spraying on apples (local use in North Carolina). Assuming that ten acres of crop land
drain into a 1 acre water body, the maximum rate of loading from runoff would be:

10 A x 3.0 Ib/A x 0.05 = 1.5 Ib/A.

Given that residues for direct application of pesticide to a 1 acre water body 6
in. deep are 734 ppb/lb ai, this loading would be expected to yield a concentration of
1.1 ppm in a water body that is 6 in. deep (1.5 Ib/A x 734 ppb/lb). It would be
expected to yield a concentration of 0.092 ppm in a water body 6 ft. deep (1.5 Ib/A x
61 ppb/lb ai).

The most sensitive fish species tested was the fathead minnow, which has a
LCjo of 88 ppm ai. This makes the maximum risk quotients 0.0125 and 0.0010 for
bodies of water 6 inches and 6 feet deep, respectively. Minimal impact on fish is
therefore expected from spraying of ethephon with ground equipment at any use site.
37

-------
Aerial Application

Minimal impact on fish is expected from aerial spray of ethephon.

Among the crops for which aerial spray is allowed, the maximum use rate is 2
Ib ai/A for use on cotton and pineapples. It is assumed that ten acres of treated crop
land will drain into a 1 acre water body. Sixty percent of the amount sprayed is
expected to reach the treatment area, and 5% of that is expected to enter aquatic habitat
via surface runoff; The maximum loading into the water body from runoff therefore
would be:

10 A x 2.0 Ib/A x 0.6 x 0.05 = 0.60 Ib

An additional 5% of the amount sprayed on an adjacent acre of land is expected
to enter the water body via spray drift. At the maximum use rate, then, the loading
into the water body from drift would be:

1 A x 2.0 Ib/A x 0.05 = O.lOlb

Thus, the total loading into the aquatic habitat would be:

0.60 Ib + O.lOlb = .70 Ib

Given that residues for direct application of a pesticide to a 1 acre water body 6
in. deep are 734 ppb/lb ai, this loading would be expected to yield a concentration of
0.51 ppm in a water body that is 6 in deep (0.70 x 734 ppb/lb ai). It would be
expected to yield a concentration of 0.043 ppm in a water body 6 ft. deep (0.70 x 61
ppb/lb ai).
The LCy) (130 ppm) for the most sensitive species (the fathead minnow) is at
least 255 times greater than the maximum EEC in either a 6-in or 6-ft pond, making all
risk quotients less than 0.004. Minimal impact on fish is, therefore, expected from
aerial spray of ethephon at any use site.

Freshwater Invertebrates

Minimal acute and chronic effects are expected for freshwater invertebrates.

The EEC's for aquatic invertebrates are identical to those calculated above for
fish. The maximum EEC is 1.1 ppm in a 6-in water body when ethephon is applied
with ground equipment at a rate of 2 Ib ai/A. The most sensitive species is Daphnia
magna which has an EC^ of 31.7 ppm. Therefore, the maximum risk quotient for
freshwater invertebrates is 1.1/31.7 = 0.035 and the level of concern is not exceeded.
38

-------
        For chronic effects of ethephon in Daphnia magna, the maximum EEC is less
 than the maximum acceptable toxicant concentration (MATC).  Thus, minimal chronic
 effects are expected for freshwater invertebrates.

        Marine and Estuarine Organisms

        Minimal effects to marine and estuarine organisms are expected from use of
 ethephon.

        Exposure of marine and estuarine habitats is expected from certain uses of
 ethephon.  The maximum use rates for these sites are 2.19 Ib ai/A when using ground
 equipment (blackberries) and 2.0 Ib ai/A when using aerial application (cotton).
 These are identical to the maximum rates used in the risk assessment for fish. Thus,
 the EEC's for marine and deep estuarine habitats are the same as those calculated
 before for a 6-ft water body (0.092 ppm for ground applications and 0.043 ppm for
 aerial applications). For shallow estuaries, the EEC's are the same as those calculated
 before for a 6-in water body (0.8 ppm for ground applications and 0.51 ppm for aerial
 applications).

       The most sensitive marine/estuarine species tested is the eastern oyster which
 has an EC^ of 60 mg ai/1. The greatest EEC is 0.8 ppm for shallow estuaries with
 ground application.  Therefore, the maximum risk quotient is 0.013 (0.8/60). Since
 the risk quotient is far less than 0.5 for the worst case scenario, minimal effects to
 marine and estuarine organisms are expected from any use of ethephon at any use site.

       Non-Target Plants

       Aquatic Plants

       No more than minimal effects are expected on aquatic plants for all use site.
 For aquatic plants, the EEC's are identical to those calculated above for fish.  The
 maximum EEC among all scenarios is 1.1 ppm for a 6 inch water body when ethephon
 is applied using ground equipment at a rate of 2 Ib ai/A.  The most sensitive aquatic
 plant is duckweed, which has an EC^ of 2.5 ppm.  Since this is greater than the
 maximum EEC, no more than minimal effects are expected on aquatic plants for all use
 site.

 Terrestrial Plants (dry land)

       Minimal effects to terrestrial plants that inhabit dry land are expected from
ground and aerial applications of ethephon.
                                   39

-------
        Ground Application

        For terrestrial plants that inhabit dry land, one acre of treated land is assumed
 to expose plants on one acre of adjacent land as the result of surface runoff. The
 maximum application rate for ground application of ethephon is 3 Ib ai/A for apples in
 North Carolina and pineapples in Hawaii.  Assuming that 5% of what is applied will
 migrate via runoff, the expected loading in the soil of an adjacent acre of land is:

                        1 Ax31b/Ax0.05 = 0.151b

        The ECjj for ryegrass, the most sensitive plant species,  is 0.24 Ib/A. Since the
 maximum loading for plants on dry land (0. 15 Ib/A) is less than the EC^, minimal
 effects are expected for these species from all ground applications of ethephon.

        Aerial Application

        When aerially applied, the soil may be contaminated from spray drift as  well as
 surface runoff. For the maximum use rate of 2 Ib/A, the total loading is:

        (1 A x 2 Ib/A x 0.6 x 0.05) + (1 A x 2 Ib/A x 0.05) = 0.16 Ib/A
                         (Runoff)            (Drift)

       This EEC is less than the EC^ for ryegrass (0.24 Ib/A).  Therefore, minimal
 detrimental effects to terrestrial plants that inhabit dry land are expected from aerial
 applications of ethephon.

 Terrestrial Plants (wet land) and Semi-Aquatic  Plants

       Risk to  semi-aquatic plants is possible from ethephon use on apples (local use in
 NC), cotton, tobacco, macadamia nuts, blackberries and pineapples. However, the
 magnitude of the risk quotients, from 1.0 to 1.5, is not particularly high.

       The following scenario is used for EEC estimates for terrestrial or semi-aquatic
 plants that inhabit low, wet areas. It is assumed that 10 acres of treated land drains
 into each acre of habitat. The runoff collects in the wet area and is assumed to
 eventually drain into the soil. Any pesticide contained within this runoff would be
 loaded into the  soil. This predicted amount of loading is compared to the  loading that
phytotoxicity tests have shown to cause a 25% inhibition of emergence and growth of
plants, the
       The preliminary EEC (PEEC) calculation for this scenario resulted in an EEC
greater than the EC^ for inhibition of emergence and growth in plants.  Therefore,
high risk to semi-aquatic plants at some use sites was predicted. As a result, a
refinement of the PEEC was completed.
                                   40

-------
        The refined model estimated the environmental concentrations in a 2-m water
 body based on the aerobic soil metabolism half-life, the K^ for desorption, the
 solubility, and the average interval between storms.  The maximum possible runoff and
 average storm interval were assumed to be 10% and 7 days, respectively. The values
 used for the K^, aerobic soil half-life, and solubility were 922 L/kg, 7.5 d, and
 124,000 mg/L. With aerial applications, the model predicts the following EEC's:

                             Application   EEC
                            Rate(lb/A)  (ppb)

                                   0.5   3.4
                                   1.0   6.8
                                   1.5  10.2
                                  2.0  13.6
                                  3.0  20.4

        However, for a plant scenario, instead of calculating the concentration of the
 chemical in water,  the rate of loading onto the soil (Ib/A) must be calculated. The
 above EEC values  were, therefore, converted to Ib/A by dividing by 56 (an EEC of 56
 ppb corresponds to loading of 1 Ib of chemical into a 1-ha water body with a depth of 2
 m). These environmental loading rates onto the soil are:

                         Application  Environmental
                        Rate (Ib/A)   Loading (Ib/A)

                                  0.5   0.06
                                  1.0   0.12
                                  1.5   0.18
                                  2.0   0.24
                                  3.0   0.36

       The EC25 for ryegrass, the species most sensitive to ethephon, is 0.24 Ib/A.
Therefore, applications at rates  of less than 2.0 Ib/A will not exceed the EC25. Since
the maximum use rate for cotton, macadamia nuts, pineapple (other than in Hawaii),
and tobacco is 2.0 Ib/A, the environmental loading just equals the EC25.  The
maximum use rate for blackberries is 2.1875 Ib/A. The environmental loading rate
predicted for this use rate is 0.26 Ib/A, which exceeds the EC25 with a risk quotient of
1.08. The Special Local Use for treatment of apples in North Carolina (NC82000700)
and pineapples in Hawaii also results in EEC's that exceed the EC25.  For both cases,
the maximum use rate is 3.0 Ib/A, and the predicted environmental loading is 0.36
Ib/A. Therefore, the risk quotient is 1.5.

       In summary, risk to semi-aquatic plants is possible from the use of ethephon on
apples (local use in NC),  cotton, tobacco,  macadamia nuts, blackberries and pineapple.

                                    41

-------
However, ethephon is a growth regulator, and as such is not intended to be toxic to
plants. Compared to herbicides, the magnitude of the risk quotients, 1.0 to 1.5, is not
particularly high.

While the potential for risk to semi-aquatic plants exists, it should not be
extensive. The risk quotient for cotton, macadamia nuts, pineapple (other than in HI),
and tobacco equals but does not exceed 1.0. Since this risk quotient is based on a high
exposure scenario, the conditions necessary to pose risk to semi-aquatic plants are
expected to occur infrequently. For use sites that have risk quotients exceeding 1.0,
the environmental impact would be geographically limited. Blackberries is a minor'
crop, and the local state use registrations involve relatively few acres. According to
the 1987 Agriculture Census, about 18,000 acres of apples are grown in North
Carolina and about 22,000 acres of pineapples are grown in Hawaii.

Endangered Species

No detrimental effects are expected for any endangered animal. However,
some uses of ethephon may harm certain endangered plants that live in wet areas.'

The above risk assessments indicated that freshwater invertebrates would be the
animals most likely to be at risk from the use of ethephon. However, the maximum
risk quotient for freshwater invertebrates was determined to be 0.035. This ratio is
less than 1/20 of the EC50, therefore, no detrimental effects are expected for
endangered freshwater invertebrates, or for any other endangered animal.

Risk to endangered semi-aquatic plants is possible from the use of ethephon on
apples (local use in NC), cotton, tobacco, macadamia nuts, blackberries, and
pineapple.

IV. RISK MANAGEMENT AND REREGISTRATION DECISION

A. Determination of Eligibility

Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether products
containing the active ingredients are eligible for reregistration. The Agency has
previously identified and required the submission of the generic (i.e. active ingredient
specific) data required to support reregistration of products containing ethephon as the
active ingredient. The Agency has completed its review of these generic data, and has
determined that the data are sufficient to support reregistration of all products'
containing ethephon. Appendix B identifies the generic data requirements that the
Agency reviewed as part of its determination of reregistration eligibility of ethephon,
and lists the submitted studies that the Agency found acceptable.
42

-------
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of ethephon and to determine that ethephon can be used without
resulting in unreasonable adverse effects to humans and the environment. The Agency
therefore finds that all products containing ethephon as the active ingredient are eligible
for reregistration. The reregistration of particular products is addressed in Section V
of this document.

The Agency made its reregistration eligibility determination based upon the
target data base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data and the data identified in Appendix B.
Although the Agency has found that all uses of ethephon are eligible for reregistration,
it should be understood that the Agency may take appropriate regulatory action, and/or
require the submission of additional data to support the registration of products
containing ethephon, if new information comes to the Agency's attention or if the data
requirements for registration (or the guidelines for generating such data) change.

1. Eligibility Decision

Based on the reviews of the generic data for the active ingredient ethephon, the
Agency has sufficient information on the health effects of ethephon and on its potential
for causing adverse effects in fish and wildlife and the environment. Therefore, the
Agency concludes that products containing ethephon for all uses are eligible for
reregistration.

The Agency has determined that ethephon products, labeled and used as
specified in this Reregistration Eligibility Decision, will not pose unreasonable risks or
adverse effects to humans or the environment.

2. Eligible and Ineligible Uses

The Agency has determined that all uses of ethephon are eligible for
reregistration.

B. Regulatory Position

The following is a summary of the regulatory positions and rationales for
ethephon. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
43

-------
1.     Tolerance Reassessment

       Tolerances Listed Under 40 CFR §180.300(a)

       The tolerances listed in 40 CFR §180.300(a) are for residues of
ethephon per se.

       Sufficient data are available to ascertain the adequacy of the established
tolerances listed in 40 CFR §180.300(a) for the following commodities: apples,
barley grain and straw, blackberries, cherries, cottonseed, Macadamia nuts,
pineapples, tomatoes, walnuts, and wheat grain and straw.  Sufficient data are
available to assess residue levels of ethephon in tobacco.

       The established tolerance of 2 ppm for residues of ethephon in/on
       cottonseed should be increased to 4 ppm.  The registrant has proposed
       an amendment to increase the currently established tolerance level for
       residues of ethephon in/on cottonseed from 2 ppm to 4 ppm.

       Pending the further amendment of the 0.33 Ib/gal SC/L product label
       (EPA Reg. No. 264-263 dated 8/11/94) to prohibit the harvesting of any
      treated pumpkins for human or animal consumption and specify that
      treatments are to be made to pumpkins for seed production only, the
      Agency has hereby concluded that the currently registered use of
      ethephon on cucumbers, squash, and pumpkins for hybrid seed
      production is a non-food use and the 0.1 ppm tolerances for  cucumbers
      and pumpkins should be revoked. [Note:  No tolerance is established for
      residues of ethephon in/on squash.]

      Blueberries, coffee, cranberries, figs, filberts, guavas, lemons, and
      tangerines, and tangerine hybrids have been deleted from ethephon
      product labels. Tolerances for residues in/on these commodities should
      be revoked.

      The Agency no longer considers pineapple forage and pineapple fodder
      raw agricultural commodities. Tolerances for residues of ethephon
      in/on these commodities should be revoked.

      Additional data are required to ascertain the adequacy of the  established
      tolerances for cantaloupes, grapes, peppers, milk, and the fat, meat,  and
      meat byproducts of cattle, goats, hogs, horses, and sheep.  The required
      cantaloupe, grape, and pepper field trials are in progress.

      No tolerances for residues of ethephon in poultry tissues or eggs have
      been established. The need for tolerances  will be assessed upon


                            44

-------
 submission and evaluation of the new poultry metabolism and feeding
 studies.  The poultry metabolism study is currently in progress.

 A summary of the ethephon tolerance reassessment and modifications in
 commodity definitions are presented in the table at the end of this
 section.

 Tolerances Listed Under 40 CFR §180.300(b)

 The tolerance listed in 40 CFR §180.300(b) is with a regional
 registration as defined in 180. l(n) for residues of ethephon per se in/on
 sugarcane. Pending the submission of sugarcane test sample storage
 information, data are available to ascertain the adequacy of this
 established tolerance.

 Tolerances Listed Under 40 CFR §185.2700 (a)

 The food additive tolerances listed in 40 CFR §185.2700 [a] are for
 residues of ethephon per se.

 Pending the receipt of adequate processed commodity storage stability
 data, sufficient data are available to ascertain the adequacy of the
 established tolerances listed in 40 CFR §185.2700 [a] for barley, milling
 fractions, except flour and wheat, milling fractions, except flour.

 The established tolerance of 12 ppm for raisins was erroneously
 excluded from 40 CFR §185.2700(a). Pending the receipt of adequate
 sample storage information and processed commodity storage stability
 data and after an appropriate tolerance is determined for residues of
 ethephon in/on grapes, the adequacy of the established food  additive
 tolerance for residues  of ethephon in raisins will be assessed. Available
 residue data indicate that a concentration factor of 4.7x is appropriate.

 Data are required from a new sugarcane processing study. This  study is
 currently in progress.

 Tolerances Listed Under 40 CFR §185.2700(b)

The existing food additive tolerance of 7 ppm listed in 40 CFR
 §185.2700  [b] on sugarcane, molasses resulting from application of
ethephon in accordance with an experimental use program should be
revoked.
                      45

-------
 Tolerances Listed Under 40 CFR §186.2700

 The feed additive tolerances listed in 40 CFR §186.2700 are for residues
 of ethephon per se.

 Pending the receipt of adequate processed commodity storage stability
 data, sufficient data are available to ascertain the adequacy of the
 established tolerances listed in 40 CFR §186.2700 for the following
 commodities: barley, milling fractions, except flour and wheat milling
 fractions, except flour.

 Pending the receipt of adequate sample storage information and
 processed commodity storage stability  data and after an appropriate
 tolerance is determined for residues of ethephon  in/on grapes, the
 adequacy of the established feed additive tolerance for residues of
 ethephon in raisin waste will be assessed.  Available residue data
 indicate that a concentration factor of 120x is appropriate.

 A new sugarcane processing study is in progress.

 New Tolerances

       Tolerances have been proposed for the following commodities:
 cottonseed meal (5 ppm); apple pomace (10 ppm), apple juice (10 ppm),
 tomato pomace  (4 ppm), and pineapple bran (12  ppm).

       Pending the receipt of adequate processed commodity storage
 stability data, sufficient data are available to support the establishment of
 the following proposed food/feed additive tolerances:  apple, juice,  10
 ppm; cotton,  meal, 5 ppm; and tomato, pomace (dried),  4 ppm.

       The Agency no longer considers dried apple pomace a feed item
 (Pesticide Assessment Guidelines,  Subdivision O, Residue Chemistry,
 TABLE II, June 1994) and available apple processing data indicate that
 residues of ethephon do not concentrate in wet apple pomace.
 Therefore,  the proposed feed additive tolerance of 10 ppm for apple
 pomace is not required.

       The Agency no longer considers pineapple bran a processed
commodity of pineapple (Pesticide Assessment Guidelines, Subdivision
O, Residue Chemistry, TABLE II, June 1994). Therefore, the proposed
feed additive tolerance of 12 ppm for pineapple bran is not required.
                      46

-------
       Pending the receipt of adequate sample storage information and
processed commodity storage stability data and after an appropriate
tolerance is determined for residues of ethephon in/on grapes, a food
additive tolerance for residues of ethephon in grape juice and a feed
additive tolerance for grape pomace (dried) must be established using a
concentration factor of 4x.

       The Agency currently recognizes cotton gin byproducts and
aspirated wheat grain fractions as raw agricultural commodities and has
determined that livestock feeding restrictions for barley forage, barley
hay, wheat forage, and wheat hay are not appropriate (Pesticide
Assessment Guidelines, Subdivision O, Residue Chemistry, TABLE II,
June 1994).  Data depicting residues of ethephon in/on cotton gin
byproducts, wheat forage, and wheat hay resulting from maximum
registered use rates are hereby required.  Data on wheat forage and hay
will be translated to barley forage and hay, respectively. Wheat grain
dust data were previously submitted which indicated that residues of
ethephon do not concentrate in aspirated wheat grain fractions.  In
accordance with guidance (issued June 2, 1994) on aspirated grain
fractions (grain dust), additional aspirated wheat grain fraction data are
not required and no tolerance is needed for residues of ethephon in/on
aspirated wheat grain fractions.  Additional ethephon residue data
requirements for cotton gin byproducts and wheat forage and hay  which
result from changes in the Livestock Feeds Table (Pesticide Assessment
Guidelines, Subdivision O, Residue Chemistry, TABLE n, June 1994)
will be imposed with this document.  On receipt of the required cotton
gin byproducts and wheat forage and hay data, the need for tolerances
for residues of ethephon in/on cotton gin byproducts, barley forage,
barley hay, wheat forage, and wheat hay will be determined.

      As a result of changes in the Livestock Feeds Table (Pesticide
Assessment Guidelines, Subdivision O, Residue Chemistry, TABLE II,
June 1994), the Agency currently recognizes tomato paste  as a processed
commodity of tomatoes and pineapple process residue as a processed
commodity of pineapples.  Available tomato processing  data indicate that
residues of ethephon do not concentrate in tomato paste, therefore, the
Agency  hereby concludes that, pending receipt of adequate processed
commodity storage stability data, no tolerance is needed for residues of
ethephon in tomato paste.  Available pineapple processing  data indicate
that residues of ethephon do not significantly concentrate in wet pulp
(1.2x) and  the Agency hereby concludes that, pending the  receipt of
adequate processed commodity storage stability data, no tolerance is
needed for  residues of ethephon in pineapple process residue.
                      47

-------
Tolerance Reassessment Summ
: •• .^S!??^- ^

Apples
Barley, grain
Barley, straw
Blackberries
Blueberries
Cantaloupes
Cattle, fat
1 Cattle, mbyp
Cattle, meat
Cherries
Coffee beans
Cottonseed
Cranberries
Cucumbers
Figs
Filberts
Goats, fat
Goats, mbyp
Goats, meat
Grapes
Guavas
Hogs, fat
Hogs, mbyp
Hogs, meat
f^^^^^S^qlpB^S^p-^1- m, > - >;*Qxya>^^
Tolerances listed under 40 CFR §180.300 (a)
5
2
10
30
20
2
0.1
0.1
0.1
10
0.1
2
5
0.1
5
0.5
0.1
0.1
0.1
2.0
O.I1
0.1
0.1
0.1
5
2
10
30
Revoke
Cannot be reassessed
Cannot be reassessed
Cannot be reassessed
Cannot be reassessed
10
Revoke
4
Revoke
Revoke

Revoke
Cannot be reassessed
Cannot be reassessed
Cannot be reassessed
Cannot be reassessed
Revoke
Cannot be reassessed
Cannot be reassessed
Cannot be reassessed





Additional residue data are
Additional feeding studies are
required.
Additional feeding studies are
Additional feeding studies are


Increase in tolerance
required/ Cotton, seed, PPOF2312

' 	 	 	 1
Registrant limiting use to


Additional feeding studies are
Additional feeding studies are
Additional feeding studies are
Additional residue data are

Additional feeding studies are
Additional feeding studies are
Additional feeding studies are
	 required. 	
                                              48

-------
Commodity
Horses, fat
Horses, mbyp
Horses, meat
Lemons
Macadamia nuts
Milk
1,
Peppers
Pineapples
Pineapple fodder
Pineapple forage
Pumpkins
Sheep, fat
Sheep, mbyp
Sheep, meat
Tangerines
Tangerine hybrids
Tomatoes
Walnuts
Wheat, grain
Wheat, straw
0.1
0.1
0.1
2
0.5
0.1
30
2
3
3
0.1
0.1
0.1
0.1
0.5
0.5
2
0.5
2
10
|;^^^E|Kraa€^^;:: ^ \
Cannot be reassessed
Cannot be reassessed
Cannot be reassessed
Revoke
0.5
Cannot be reassessed
Cannot be reassessed
2
Revoke
Revoke
Revoke
Cannot be reassessed
Cannot be reassessed
Cannot be reassessed
Revoke
Revoke
2
0.5
2
10
;..- ':-::. ••• ; ' -S;C^mmdij/Clc?/t«c/', ;, \ ' -
%# ^^mmo^^i^i^n, , ' ;•
jtSSiiSSSSi^SSSi^^SSS^SSSSSm^SSSS^Ssss^^ssss^ssss^^sss
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^•••••^^••^^^••••••i
Additional feeding studies are
Additional feeding studies are
Additional feeding studies are


Additional feeding studies are
Additional residue data are
required.

Pineapple fodder and pineapple
forage are no longer considered
as RACs.

Use limited to pumpkins grown
Additional feeding studies are
Additional feeding studies are
required.
Additional feeding studies are






Proposed Tolerances to be listed under 40 CER §180.300(a)

Sugarcane
Tolerances listed under 40 CER §180.30(Hb)
0.1
0.1
Pending receipt of sample storage
information the tolerance may be
reassessed.
Regional registration (HI onlvl.
Tolerances listed under 40 CFR §185.2700 te)
Barley, milling
fractions, except flour
Sugarcane, molasses
5.0
1.5
5

Barley, milled fractions (except
flour).
Additional data are required.
49

-------
  Wheat, milling
  fractions, except flour
                                         Wheat, milled fractions (except
                                                    flour).
                               Tolerances listed under 40 CFR §185.2700 (b)
                                                       Revoke
                                        Experimental use program was
                                           scheduled to expire 7/88.
  Apple juice
                  Proposed Food Additive Tolerances to be listed under 40 OER §185.2700
 N/A
       lOppm
                                                                         Tolerance proposed for apples,
                                                                          juice. (Pending the receipt of
                                                                           adequate storage stability  for
                                                                           processed commodities, an
                                                                           appropriate tolerance will be
                                                                         __,	    determined).
 Grape juice
None
Cannot be reassessed
 Raisins
.12'
                                                Cannot be reassessed
Barley, milling
fractions, except flour
Raisin waste
Sugarcane, molasses
                                   Tolerances listed under §186.2700
  Concentration factor of 4x to be
  used for tolerance on grape juice
  once an appropriate tolerance for
   grapes is determined/Grape.*1,
   juice. (Pending the receipt of
      adequate sample storage
  information and storage stability
  for processed commodities,  an
   appropriate tolerance will be
          determined).
Concentration factor of 4.7x to be
used for tolerance on raisins once
an appropriate tolerance for grapes
  is detenriined/Gropej, raisins.
  (Pending the receipt of adequate
  sample storage information and
  storage stability for processed
   commodities, an appropriate
  tolerance will be determined).
                                       Barley, milled fractions (except
                                65.0
              Cannot be reassessed
                                               Cannot be reassessed
                        Concentration factor of 120x to
                       be used to determine tolerance for
                        raisin waste once an appropriate
                          tolerance is determined for
                         grapes/Grapes, raisin, waste.
                        (Pending the receipt of adequate
                        sample storage information and
                         storage stability for processed
                         commodities, an appropriate
                        tolerance will be determined).
                        Sugarcane processing study in
                                                  50

-------
Commodity
Wheat, milling
fractions, except flour
Pro
Cottonseed meal
Grape pomace (dried)
Tomato pomace, dried
Current Tolerance
ftspuW -5
5.0
'„ J Tolerance [Z^_-
, • ReMsessnwntipi^ •
5
Comment/ Cbrrecf
• *•*' ^-j. ' i<
Cotttttwdity Jtefinition
Wheat, milled fractions (except
flour).
posed Feed Additive Tolerances to be listed under §186.2700
None
None
None
5 ppm
Cannot be reassessed
4 ppm
Tolerance proposed for cottonseed
meal. (Pending the receipt of
adequate storage stability for
processed commodities, an
appropriate tolerance will be
determined).
Concentration factor of 4x to be
used for tolerance on raisins once
an appropriate tolerance for grapes
is determined/ Grapes, pomace,
dried. (Pending the receipt of
adequate storage stability for
processed commodities, an
appropriate tolerance will be
Tolerance proposed for dried
tomato pomace. (Pending the
receipt of adequate storage
stability for processed
commodities, an appropriate
tolerance will be determined)
The established tolerance of 0.1 ppm for guavas and 12 ppm for raisins were erroneously excluded from
40 CFR §180.300(a) and §185.2700(a), respectively.
CODEX HARMONIZATION

Several maximum residue limits (MRLs) for ethephon have been
established by the Codex Committee on Pesticide Residues, a committee within
the Codex Alimentarius Commission, an international organization formed to
promote the coordination of international food standards. Both Codex and the
U.S. regulate ethephon/KT se. The Codex MRLs, applicable U.S. tolerances,
and recommendations for harmonizing U.S. tolerances with Codex MRLs are
presented below.
51

-------
                      Codex MRLs and applicable U.S. tolerances.
commodity
SSSSSS SS5^SSBSS8S8^S^S:
Apple
1 Blackberries
Blueberries
Cherries
Coffee beans
Cranberry
Currant, Black
Fig
Grapes
Hazelnuts
Lemons and Limes
Mandarins
Melons, except
watermelon
Onion, bulb
Peach
Peppers
Pineapple
Tomato
Walnuts 	
MRL
(mg/%) l
•— r^
30
20
10
0.1
5
5
5
10
0.5
2
0.5
2
0.5
0.5
30
2
3
0.5
UJS.
TMemriee
(ppm)
1 5
30
20
10
0.1
5
None
5
2
None
2
None
2
(cantaloupes)
None
None
30
2
2
0.5
=====L
Recommendation
=£======================-———-
Compatibility exists.
Compatibility exists.
U.S. tolerance to be revoked; no
registered uses.
Compatibility exists.
— t 	 ^ 	 ^i_ 	 i
U.S. tolerance to be revoked; no
registered uses.
U.S. tolerance to be revoked; no
registered uses.

U.S. tolerance to be revoked; no
registered uses.
Field residue data remain
outstanding.

U.S. tolerance to be revoked; no
registered uses. ||
II
Field residue data on cantaloupes
remain outstanding. ||


Field residue data remain
outstanding.
	 — ~ 	 	
Compatibility exists. ||
Increase U.S. tolerance,
toxicological considerations
permitting.
Compatibility exists.
=^==^^==!=!*=^==^==:====
All ethephon MRLs are Step 4.
                                        52

-------
The following conclusions can be made regarding efforts to harmonize the U.S. tolerances
with the Codex MRLs:

o Compatibility between the U.S. tolerances and Codex MRLS exists for apples,
blackberries, cherries, pineapples, and walnuts.

o The Codex MRLs proposed for ethephon residues in/on tomatoes (3 ppm) is
higher than the established U.S. tolerance (2 ppm). Should the Codex
Committee adopt this recommendation, compatibility could be achieved by
increasing the U.S. tolerance to 3 ppm.

2. Risk Mitigation

A. Acute Dietary Risks

The Agency estimates indicate that acute dietary exposures to
infants (less than 1 year of age) may be of concern when the estimated
95th percentile of exposure is used. The Agency however, has
concluded that these risk values represent an unrealistic worst case
situation because the following conservative assumptions were employed
in calculating the acute dietary risks:

1. The Agency assumed that all food crops on which ethephon is
registered have been treated with ethephon and that maximum
residue levels reported in or on unwashed, unpeeled, uncooked
commodities at the farm gate are present on all foods. However
usage data indicate that the percentage of treated crops to be
processed into major infant foods on which ethephon is registered
is < 10% or even "negligible".

2. The probable residue dilution that occurs in processed infant
foods was not taken into account.

3. Ethephon degrades fairly rapidly to ethylene, phosphate and
chloride in neutral and alkaline environments. Therefore, by the
time the food has cleared distribution channels and/or processing
plants, residues at the dinner table are likely to be significantly
lower than high-end levels at the farm gate.

For the reasons stated above the Agency believes it is unlikely
that infants and children will be exposed to ethephon treated
commodities at levels that will result in acute dietary risk.
53

-------
        B.  Risks to Plants

               The Agency concludes that while the potential for risk to plants
        exists, the risk should not be extensive.  As stated in Section ffl, C, 2, b
        the  risk quotients for effects on semi-aquatic plants equal but do not
        exceed 1.0 for cotton, macadamia nuts, pineapples (outside Hawaii), and
        tobacco.  The risk quotient  for dry land plants also equals 1.0 for use on
        pineapples in Hawaii. Use  sites for which the risk quotients for semi-
        aquatic plants exceed 1.0 are blackberries, apples in North Carolina and
        pineapples in Hawaii. All of these sites are limited geographically.

               Rhone-Poulenc has responded to Agency concerns by proposing
        the following risk mitigation measures:

        1.  reduce the maximum use rate for blackberries and apples in North
        Carolina to 2.0 Ibs per acre, and

        2. provide information indicating that ethephon is only occasionally
        used at maximum rates when certain weather conditions exist, such as
        cool temperatures.

              The Agency concludes that with these risk mitigation measures
        the risk to nontarget plants from the use of ethephon will be limited.

 3.      Endangered Species Statement

        The  Agency has concerns about the exposure of threatened and
 endangered plant species to ethephon as discussed above in the science
 assessment chapter.

        Currently, the Agency is developing a program ("The Endangered
 Species Protection Program") to identify  all pesticides whose use may cause
 adverse impacts on endangered and  threatened species and to implement
 mitigation measures that will eliminate the adverse impacts.  The program
 would require use modifications or  a generic product label statement, requiring
 users to consult county-specific bulletins. These bulletins would provide
 information about specific use restrictions to protect endangered and threatened
 species in the county. Consultations with the Fish and Wildlife Service may be
 necessary to assess risks to newly listed species or from proposed new uses.

       The Agency plans to publish a description of the Endangered Species
Program in the Federal Register in 1995 and to have enforceable county-
specific bulletins available approximately one year after. Because the Agency is
taking this approach for protecting endangered and threatened species, it is not
imposing label modifications at this  time through the RED. Rather, any


                             54

-------
requirements for product use modifications will occur in the future under the
Endangered Species Protection Program.

4.     Labeling Rationale

        A. Worker Protection Standard

       Any product whose labeling reasonably permits use in the production of
an agricultural plant on any farm, forest, nursery, or greenhouse must comply
with the labeling requirements of PR Notice 93-7, "Labeling Revisions
Required by the Worker Protection Standard (WPS), and PR Notice 93-11,
"Supplemental Guidance for PR Notice 93-7, which reflect the requirements of
EPA's labeling regulations for worker protection statements (40 CFR part 156,
subpart K). These labeling revisions are necessary to implement the Worker
Protection .Standard for Agricultural Pesticides (40 CFR part 170) and must be
completed in accordance with, and within the deadlines specified in, PR Notices
93-7 and 93-11. Unless otherwise specifically directed in this RED, all
statements required by PR Notices 93-7 and 93-11 are to be on the product label
exactly as instructed in those notices.

       After April 21, 1994, except as otherwise provided in PR Notices 93-7
and 93-11, all products within  the scope of those notices must bear WPS PR
Notice complying labeling when they are distributed or sold by the primary
registrant or any supplementally registered distributor.

       After October 23,  1995, except as otherwise provided in PR Notices
93-7 and 93-11, all  products within the scope of those notices must bear WPS
PR Notice complying  labeling  when they are distributed or sold by any person.

       Uses within  the scope of the Worker Protection Standard

       The WPS established certain worker-protection requirements (personal
protective equipment,  restricted entry intervals, etc.) to be specified on the label
of all products that contain uses within the  scope of the WPS.  Uses within the
scope of the WPS include  all commercial (non-homeowner) and research uses
on farms,  forests, in nurseries, and greenhouses to produce agricultural plants
(including food, feed,  and fiber plants, trees, flowers, shrubs, ornamentals,  and
seedlings). Uses within the scope include not only uses on plants, but also uses
on the  soil or planting medium the plants are (or will be) grown in.

       Some of the  registered uses of ethephon are within the scope of the WPS
and some uses are outside  the scope of the WPS. Those that are outside the
scope of the WPS include  use:
                             55

-------
        - on flowering fruit and ornamental trees growing in ornamental
        gardens, parks, golf courses, and public or private lawns and grounds
        that are intended only for decorative or environmental benefit;

        - on home garden tomatoes, geraniums, azaleas, bromeliads, and potted
        hyacinths and daffodils.

        Personal Protective Equipment (PPE) for Handlers
               (Mixer/Loader/Applicators)

        For each end-use product, PPE requirements for pesticide handlers will
 be set during reregistration in one of two ways:

        1. If EPA has no special concerns about the acute or other adverse
        effects of an active ingredient, the PPE for pesticide handlers will be
        based on the acute toxicity of the end-use product. For occupational-use
        products, PPE will be established using the process described in PR
        Notice 93-7 or more recent EPA guidelines.

        2. If EPA has special concerns about an active ingredient due to very
        high acute toxicity or to certain other adverse effects, such as allergic
        effects or delayed effects (cancer, developmental toxicity, reproductive
        effects, etc):

              -In the RED for that active  ingredient, EPA may establish
              minimum or "baseline" handler PPE  requirements that pertain to
              all or most occupational end-use products containing that active
              ingredient.

              -These minimum PPE requirements must be compared with the
              PPE that would be designated on the basis of the acute toxicity of
              each end-use product.
                        stringent choice for each type of PPE (i.e., bodywear,
              hand protection, footwear, eyewear, etc.) must be placed on the
                        : end-use oroduct.
-The more
nand protevuvu, ivswirrwcu, v
label of the end-use product.
       There are no special toxicological concerns about ethephon that warrant
the establishment of active-ingredient-based minimum PPE requirements.

Entry Restrictions

       Entry Restrictions for Occupational-Use Products (WPS Uses)
                             56

-------
Restricted Entry Interval - Under the Worker Protection Standard (WPS),
interim restricted entry intervals (REI) for all uses within the scope of the WPS
are established based on the acute toxicity of the active ingredient.  The toxicity
categories of the active ingredient for acute dermal toxicity, eye irritation
potential, and skin irritation potential are used to determine the interim WPS
REI. If one or more of the three acute toxicity effects are in toxicity category
I, the interim WPS REI is established at 48 hours.  If none of the acute toxicity
effects are in category I, but one or more of the three is classified as category
n, the interim WPS REI is established at 24 hours. If none of the three acute
toxicity effects are in category I or n, the interim WPS REI is established at 12
hours.  A 48-hour REI is increased to 72 hours when an  organophosphate
pesticide is applied outdoors in arid areas based on potential dermal and eye
irritation. In addition, the WPS specifically retains two types of REI's
established by the Agency prior to the promulgation of the WPS: (1) product-
specific REI's established on the basis of adequate data and (2) interim REI's
that are longer than those that would be established under the WPS.

       The interim WPS REI in effect until now was  48  hours.  A 24-hour
reentry interval was established for these uses by the 1988 Guidance for the
Reregistration of Ethephon.  That reentry interval was converted into a 48-hour
restricted-entry interval through modifications specified in PR Notice 93-7,
which implemented the labeling requirements of the 1992 Worker Protection
standard for Agricultural Pesticides.

       For occupational end-use products containing ethephon as an active
ingredient, the Agency is now establishing 48 hour REI pertaining to each use
of the product that is within the scope of the Worker Protection Standard.  This
48-hour REI is to be increased to 72 hours when applied outdoors in arid  areas.
The WPS places very specific restrictions on entry during restricted-entry
intervals when that entry involves contact with treated surfaces.  These existing
WPS protections are sufficient to mitigate post-application exposures of workers
who contact surfaces treated with ethephon.

Early Entry PPE - The WPS establishes very specific restrictions on entry by
workers to areas that remain under a restricted-entry interval if the entry
involves contact with treated surfaces.  Among those restrictions, are a
prohibition of routine entry to perform hand labor tasks and requirement that
PPE be worn during entry permitted under WPS when there is contact with
treated surfaces. Personal protective equipment requirements for persons who
enter areas that remain under a restricted-entry interval and contact treated
surfaces are based on the toxicity concerns about the active ingredient. The
requirements are set in one of two ways.
                             57

-------
        1.     If EPA has no special concerns about the acute or other adverse
               effects of an active ingredient, it establishes the early-entry PPE
               requirements based on the acute dermal toxicity, skin irritation
               potential, and eye irritation potential of the active ingredient.

        2.     If EPA has special concerns about an active ingredient due to
               very high acute toxicity or to certain other adverse effects, such
               as allergic effects, cancer, developmental toxicity, or
               reproductive effects, it may establish early entry PPE
               requirements that are more stringent than would be established
               otherwise.

        Based on the acute toxicity of the active ingredient ethephon (toxicity
 category I for primary skin irritation), the PPE required for early entry is
 coveralls over long-sleeved shirt and long pants, chemical-resistant gloves such
 as any waterproof gloves, chemical-resistant footwear plus socks, and chemical-
 resistant headgear for overhead exposures.  In addition, since ethephon is
 classified as toxicity category I for eye irritation potential, protective eyewear is
 also required.

 Double Notification When an active ingredient within the scope of the Worker
 Protection Standard for Agricultural Pesticides (WPS) is classified as  toxicity
 category I for acute dermal toxicity or for primary skin irritation, the WPS
 requires that agricultural workers must be orally warned of application AND
 that WPS warning signs must be posted at entrances to treated areas.  Since
 ethephon is classified as toxicity category I  for primary skin irritation, EPA is
 specifying that a statement requiring such "double" notification be placed on the
 labeling of all ethephon end-use products which contain uses within the scope of
 the WPS.

 Refer to Section V for other required worker protection label requirements.


       B.  Environmental Hazard

       The Agency is  requiring labeling to address risk to wetland areas.
 (Refer to  Section V).

       C.  Spray Drift Advisory

       The Agency has been working with the Spray Drift Task Force, EPA
Regional Offices and State Lead Agencies for pesticide regulation to develop the
best spray drift management practices.  The Agency is now requiring interim
measures that must be  placed on product labels/labeling as specified in Section
V. Once the Spray Drift Task Force completes their  studies, submits data, and


                              58

-------
the Agency evaluation is completed, there may be further refinements in spray
drift management practices.
V. ACTIONS REQUIRED BY REGISTRANTS

This section specifies the data requirements and responses necessary for the
reregistration of both manufacturing-use and end-use products.

A. Manufacturing-Use Products

1. Additional Generic Data Requirements

The generic data base supporting the reregistration of ethephon for the
above eligible uses has been reviewed and determined to be substantially
complete. However, additional confirmatory data are needed to fulfill
requirements for the studies listed below:

Product chemistry
Animal metabolism (poultry)
Residue analytical method in plants and animals
Storage stability
Magnitude of the residue in plants:
peppers, cantaloupes, grapes, wheat forage and hay and cotton
gin byproducts
Magnitude of the residue in processed sugarcane
Magnitude of the residue in poultry and ruminant
Batch equilibrium on the degradate of 2-hydroxy ethyl phosphonic acid
Acute and subchronic neurotoxicity

B. End-Use Products

1. Additional Product-Specific Data Requirements

Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix
G, the Product Specific Data Call-In Notice.

Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria (Appendix F) and if not, commit to
conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then study MRID numbers should be cited
according to the instructions in the Requirement Status and Registrants
Response Form provided for each product.

-------
  2.     Labeling Requirements for End-Use Products

        A. Worker Protection

  Personal Protective Equipment for Handlers

        The personal protective equipment (PPE) for handlers is to be based on
  the toxicity of the end-use product.  See PR Notice 93-7 or more recent Agency
  guidance for instructions on establishing PPE for occupational handlers.  If PPE
  is necessary for homeowner uses of ethephon, such PPE will be established by
  EPA during end use product reregistration.

  Entry Restrictions for Occupational-Use Products (WPS Uses)

        The Agency is establishing a 48-hour restricted entry interval (REI).
 The REI increases to 72 hours in outdoor areas where average rainfall is less
 than 25 inches a year.  Personal protective equipment required for WPS-
 permitted early entry into treated areas is coveralls over long-sleeved shirt and
 long pants, chemical-resistant gloves such as  any waterproof gloves, chemical-
 resistant footwear plus socks. Chemical-resistant headgear is only required if
 potential exists for overhead exposures.  In addition, since ethephon is classified
 as toxicity category I for eye irritation potential, protective eyewear is also
 required.

 Entry Restrictions for Occupational-Use Products (Non WPS Uses)

       Some registered uses of ethephon are outside the scope of the Worker
 Protection Standard (WPS).  For nonWPS uses the Agency is requiring the
 following.

       "Do not allow people or pets to touch treated plants until the sprays have
       dried."

Entry Restrictions for Homeowner-Use Products

       Some products containing ethephon have directions for use by
homeowners. The Agency is concerned about post-application exposures to
homeowners following application of ethephon.  Therefore, the Agency is
requiring that home-use  products contain the following requirement:

       "Do not allow people or pets to touch treated plants until the sprays have
      dried."
                             60

-------
 Other Labeling Requirements

 Reduce PPE when Engineering Controls Used

       "When handlers use closed systems, enclosed cabs, or aircraft in a
       manner that meets the requirements listed in the Worker Protection
       Standard for Agricultural Pesticides (WPS) [40 CFR 170.240(d)(4-6)],
       the handler PPE requirements may be  reduced or modified as specified
       in the WPS."

 User Safety Requirements

       "Follow manufacturer's instructions for cleaning/maintaining PPE.  If
       no such instructions exist for washables, use detergent and hot water.
       Keep and wash PPE separately from other laundry."

       "Discard clothing and other absorbent  materials that have
       been drenched or heavily contaminated with this product's
       concentrate. Do not reuse them."

 User Safety Statements

       "Users should wash hands before eating, drinking,
       chewing gum, using tobacco, or using  the toilet."

       "Users should remove clothing immediately if
       pesticide gets inside."

       "Users should remove PPE immediately after
       handling this product.  As soon as possible, wash
       thoroughly and change into clean clothing. Wash
       the outside of gloves before removing."

Application Restrictions

       "Do not apply this product in a way that will
       contact workers or other persons, either directly  or
       through drift. Only protected handlers may be in
       the area during application."
                             61

-------
 Notification

       "Notify workers of the application by warning
       them orally and by posting warning signs at
       entrances to treated areas."

       B. Environmental Hazard

       The following precautionary statement is required to address risks to
 wetlands:

 "Do not apply directly to water, or to areas where surface water
 is present or to intertidal areas below the mean high water
 mark."

       For residential use sites (i.e. ornamental trees, shrubs, vines, and
 herbaceous plants), the statement "do not apply directly to water" may be used
 in lieu of the above statement.

       C. Spray Drift

       The following language must be placed on each product label that can be
applied aerially:

       "AVOIDING SPRAY DRIFT AT THE APPLICATION SITE IS
      THE RESPONSIBILITY OF THE APPLICATOR."

       "The interaction of many equipment-and-weather-related factors
      determine the potential for spray drift. The applicator is
      responsible for considering all these factors when making
      decisions."

      "The following drift management requirements must be followed
      to avoid off-target movement from aerial applications to
      agricultural field crops. These requirements do not apply to
      forestry applications, public health uses or to applications using
      dry formulations."

             1.  "The distance of the outer most nozzles on the boom
            must not exceed 3/4 the length of the wingspan or rotor."

            2.  "Nozzles must always point backward parallel with the
            air stream and never be pointed downwards more than 45
            degrees."
                           62

-------
             "Where states have more stringent regulations, they
             should be observed."

       The applicator should be familiar with and take into account the
information covered in the Aerial Drift Reduction Advisory below.

AERIAL DRIFT REDUCTION ADVISORY
       The following aerial drift reduction advisory information must be
contained in the product labeling:

[This section is advisory in nature and does not supercede the mandatory label
requirements].

       INFORMATION ON DROPLET SIZE

             The most effective way to reduce drift potential is to apply large
       droplets.  The best drift management strategy is to apply the largest
       droplets that provide sufficient coverage and control. Applying larger
       droplets reduces drift potential, but will not prevent  drift if applications
       are made improperly, or under unfavorable environmental conditions
       (See Wind, Temperature and Humidity, and Temperature Inversions).
      CONTROLLING DROPLET SIZE

             o     Volume - Use high flow rate nozzles to apply the highest
                   practical spray volume.  Nozzles with higher rated flows
                   produce larger droplets.

             o     Pressure - Do not exceed the nozzle manufacturer's
                   recommended pressures. For many nozzle types lower
                   pressure produces larger droplets.  When higher flow
                   rates are needed, use higher flow rate nozzles instead of
                   increasing pressure.

             o     Number of nozzles - Use the minimum number of nozzles
                   that provide uniform coverage.

             o     Nozzle Orientation - Orienting nozzles so that the spray is
                   released parallel to the airstream produces larger droplets
                   than other orientations and  is the recommended practice.
                   Significant deflection from horizontal will reduce droplet
                   size and increase drift potential.
                            63

-------
        o      Nozzle Type - Use a nozzle type that is designed for the
               intended application.  With most nozzle types, narrower
               spray angles produce larger droplets. Consider using
               low- drift nozzles. Solid stream nozzles oriented straight
               back produce the largest droplets and the lowest drift.

  BOOM LENGTH

        For some use patterns, reducing the effective boom length to less
  than 3/4 of the wingspan or rotor length may further reduce drift
  without reducing swath width.

  APPLICATION HEIGHT

        Applications should not be made at a  height greater than 10 feet
  above the top of the target plants unless a greater height is required for
  aircraft safety.  Making applications at the lowest height that is safe
  reduces exposure of droplets to evaporation and wind.

 SWATH ADJUSTMENT

        When applications are made with a crosswind, the swath will be
 displaced downwind. Therefore, on the up and downwind edges of the
 field, the applicator should compensate for this  displacement by
 adjusting the path of the aircraft upwind.  Swath adjustment distance
 should  increase, with increasing drift potential (higher wind, smaller
 drops, etc.).

 WIND

       Drift potential is lowest between winds speeds of 2 - 10 mph.
 However, many factors, including droplet size and equipment type
 determine drift potential at any given speed.   Application should be
 avoided below 2 mph due to variable wind direction and high inversion
 potential.  NOTE:  Local terrain can influence wind patterns.  Every
 applicator should be familiar with local wind patterns and how they
 affect spray drift.

 TEMPERATURE AND HUMIDITY

      When making applications in low relative humidity, set up
equipment to produce larger droplets to compensate for evaporation.
Droplet  evaporation is most severe when conditions are both hot and
dry.
                      64

-------
 TEMPERATURE INVERSIONS

       Applications should not occur during a temperature inversion
 because drift potential is high. Temperature inversions restrict vertical
 air mixing, which causes small suspended droplets to remain in a
 concentrated cloud. This cloud can move in unpredictable directions due
 to the light variable winds common during inversions.  Temperature
 inversions are characterized by increasing temperatures with altitude and
 are common on nights with limited cloud cover and light to no wind.
 They begin to form as the sun sets and often continue into the morning.
 Their presence can be indicated by ground fog; however, if fog is not
 present, inversions can also be identified by the movement of smoke
 from a ground source or an aircraft smoke generator.  Smoke that layers
 and moves laterally in a concentrated cloud ( under low wind conditions)
 indicates an inversion, while smoke that moves upward and rapidly
 dissipates indicates good vertical air mixing.

 SENSITIVE AREAS

       The pesticide should only be applied when the potential for drift
 to adjacent sensitive areas (e.g. residential areas, bodies of water, known
 habitat for threatened or endangered species, non-target crops) is
 minimal (e.g, when wind is blowing away from the sensitive areas).

 D. Residue Chemistry Label Requirements

       The following label revisions must be added to pertinent end-use
 products:

 -Product labels must be amended to reflect a maximum allowable use
 rate of 2 Ib ai/A/season for application of ethephon to cotton.

 -Label directions for apples, cranberries, carob, and olives that are for
 ornamental use only must be clearly designated as such.

 -The 0.33 Ib/gal SC/L label (264-263) must be amended to prohibit the
 harvesting of any  treated pumpkins for human or animal consumption
 and must specify that treatments are to be made to pumpkins for seed
production only.

-Labels must be amended to reduce the maximum use rate for
blackberries  and for apples in NC (24C) to 2.0 Ib per acre.  (Refer to
Section IV, B, 2 for a discussion of the risk mitigation measures
proposed by  Rhone-Poulenc).
                      65

-------
        The Agency has completed the review of available residue data to
support the reregistration of Rhone-Poulenc end-use products. The following
table identifies the currently accepted food/feed use patterns for the Rhone-
Poulenc products only.  Data will be required for all new product registrations
or new uses where the label use rates exceed the rates listed below. The
Agency is requiring that all end-use product labels be amended such that they
are consistent with the basic producer labels.
                            66

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C.     Existing Stocks

       Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this Reregistration
Eligibility Decision (RED). Persons other than the registrant may generally distribute
or sell such products for 50 months from the date of the issuance of this RED.
However, existing stocks time frames will  be established case-by-case, depending on
the number of products involved, the number of label changes, and other factors. Refer
to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register,
Volume 56, No. 123, June 26, 1991.

       The Agency has determined that registrants may distribute and sell products
bearing old labels/labeling, i.e., labels absent the modifications specified in this RED
document,  except as noted below, for 26 months from the date of issuance of this
RED.  Persons other than the registrant may distribute or sell such products for 50
months from the date of the issuance of this RED. Registrants and persons other than
registrants  remain obligated to meet pre-existing Agency imposed label changes and
existing stocks requirements applicable to products they sell or distribute.
                                    74
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m dose for a single application to a single site. System calculated.
m dose for a single application to a single site as related to soil texture (Herbicide claims only) .
im number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications p<
is expressed as "4/3 yr"
m dose applied to a site over a single crop cycle or year. System calculated.
m Interval between Applications (days)
cted Entry Interval (days)

E E E E
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R ABBREVIATIONS
Appl. Rate (AI unless :
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Appl . Rate (AI unless :
otherwise)
Tex. Max. Dose :
# Apps @ Max. Rate :
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of irrigation system.
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ater.
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k on cover crops in treated areas .
on cover crops in treated areas .
ated areas or cut treated crops for feed.
harvest for forage or hay.
seed or seed screenings to livestock.
PHE NUMBER OF TIME UNITS (HOURS, DAYS, ETC.) DESCRIBED IN THE LIMITATION.
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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
                         89
-------
-------
                               GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Ethephon covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Ethephon in all products,
including data requirements for which a "typical formulation" is the test substance.

       The data table is organized in the following format:

       1.  Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield,  VA 22161  (703)
487-4650.

       2.  Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements  apply. The following letter designations are used for the given  use patterns:

                          A     Terrestrial food
                          B     Terrestrial feed
                          C     Terrestrial non-food
                          D     Aquatic food
                          E     Aquatic non-food outdoor
                          F     Aquatic non-food industrial
                          G     Aquatic non-food residential
                          H     Greenhouse food
                          I      Greenhouse non-food
                          J      Forestry
                          K     Residential
                          L     Indoor food
                          M     Indoor non-food
                          N     Indoor medical
                          O     Indoor residential

       3.  Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study.  This normally is the Master Record
Identification (MRID)  number, but may be a "GS" number if no MRID number has been
assigned.  Refer to the Bibliography appendix for a complete citation of the study.
                                          91
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APPENDIX C.  Citations Considered to be Part of the Data
     Base Supporting the Reregistration of Ethephon
                         103
-------
104
-------
                               GUIDE TO APPENDIX C

 1.     CONTENTS OF BIBLIOGRAPHY.  This bibliography contains citations of all studies
       considered relevant by EPA in arriving at the positions and conclusions stated
       elsewhere in the Reregistration Eligibility Document.  Primary sources for studies in
       this bibliography have been the body of data submitted to EPA and its predecessor
       agencies in support of past regulatory decisions.  Selections from other sources
       including the published literature, in those instances where they have been considered,
       are included.

2.     UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
       case of published materials, this corresponds closely to an article.  In the case of
       unpublished materials submitted to the Agency, the Agency has sought to identify
       documents at a level parallel to the published article from within the typically larger
       volumes in which they were submitted. The resulting "studies" generally have a
       distinct title (or at least a single subject),  can stand alone for purposes of review and
       can be described with a conventional bibliographic citation.  The Agency has also
       attempted  to unite basic documents and commentaries upon them, treating them as a
       single study.

3.     IDENTIFICATION OF ENTRIES. The  entries in this bibliography are sorted
       numerically by Master Record Identifier,  or "MRID number".  This number is unique
       to the citation,  and should be used whenever a specific reference is required.  It is not
       related to the six-digit  "Accession Number" which has been used to identify volumes of
       submitted  studies (see paragraph 4(d)(4) below for further explanation). In a few
       cases, entries added to the bibliography late in the review may be preceded by a nine
       character temporary identifier. These entries are listed after all MRID entries.  This
       temporary identifying number is also to be used whenever specific reference is needed.

4.     FORM OF ENTRY.  In addition to the Master Record Identifier (MRID), each entry
       consists of a citation containing standard elements followed, in the case of material
       submitted to EPA, by a description of the earliest  known submission.  Bibliographic
       conventions used reflect the standard of the American National  Standards Institute
       (ANSI), expanded to provide for certain special needs.

       a     Author.  Whenever the author could confidently be identified, the Agency  has
             chosen to show a personal author.  When no individual was identified, the
             Agency has shown an identifiable  laboratory or testing facility as the author.
             When no author or laboratory could be identified, the Agency has shown the
             first submitter as the author.

       b.     Document date. The date of the study is taken directly from the document.
             When the date is followed by a question mark, the bibliographer has deduced
             the date from the evidence contained in the document. When the date appears


                                          105
-------
       as (19??), the Agency was unable to determine or estimate the date of the
       document.

c.      Title.  In some cases, it has been necessary for the Agency bibliographers to
       create or enhance a document title.  Any such editorial insertions are contained
       between square brackets.

d.      Trailing parentheses.  For studies submitted to the Agency in the past, the
       trailing parentheses include (in addition to any self-explanatory text) the
       following elements describing the earliest known submission:

       (1)    Submission date. The date of the earliest known submission appears
             immediately following the word "received."

       (2)    Administrative number. The next element immediately following the
             word "under"  is the registration number, experimental use permit
             number, petition number, or other  administrative number associated
             with the earliest known submission.

       (3)    Submitter.  The third  element is the submitter.  When authorship is
             defaulted to the submitter, this element is omitted.

       (4)    Volume Identification (Accession Numbers). The final element in the
             trailing parentheses identifies the EPA accession number of the volume
             in which the original submission of the study appears.  The six-digit
             accession number follows the symbol "CDL," which stands for
              "Company Data Library."  This accession number is in turn followed by
             an alphabetic suffix which shows the relative position of the study within
             the volume.
                                   106
-------
                                BIBLIOGRAPHY
 MRID
CITATION
00009181    Atkins, E.L., Jr; Anderson, L.D.; Greywood, E.A. (1969)  Effect of Pesticides
             on Apiculture: Project No. 1499.  (Unpublished study received Jul 29, 1976
             under 352-342; prepared by Univ. of California-Riverside, Dept. of
             Entomology, submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.;
             CDL: 224800-C)

00026040    Beavers, J.B.; Fink, R.; Brown, R. (1979) Final Report: Acute Oral
             LD50~Mallard Duck: Project No. 113-146. (Unpublished study received Dec
             19, 1979 under 264-267; prepared by Wildlife International, Ltd. in
             cooperation with Washington College, submitted by Union Carbide Agricultural
             Products Co., Ambler, Pa.; CDL: 099158-A)

00026041    Beavers, J.B.; Fink, R.; Brown, R. (1979) Final Report: Acute Oral
             LD50~Bobwhite Quail: Project No. 113-145.  (Unpublished study received Dec
             19, 1979 under 264-267; prepared by Wildlife International, Ltd. in
             cooperation with Washington College, submitted by Union Carbide Agricultural
             Products Co.,. Ambler, Pa.; CDL: 099158-B)

00027493    Beavers, J.B.; Fink, R.; Brown, R. (1978) Final Report: Acute Oral
             LD50~Bobwhite Quail: Project No. 164-104.  (Unpublished study received Apr
             3,  1980 under 1529-EX-2; prepared by Wildlife International, Ltd. in
             cooperation with Washington College, submitted by GAP Corp., Chemical
             Div., New York, N.Y.; CDL: 099355-A)

00027495    Bentley, R.E. (1974) Acute Toxicity of CPGR Formulation and CPGR 100% to
             Bluegill (Lepomis macrochirus) and Rainbow Trout (Salmo gairdneri).
             (Unpublished study received Apr 3, 1980 under 1529-EX-2; prepared by
             Bionomics, EG&G Environmental Consultants, submitted by GAP Corp.,
             Chemical Div.,  New York, N.Y.; CDL:099355-D)

00027496    Foote, K.C. (1978) Toxicity Test of GAF's Corporation: Teceth 75 8065-20:
             Contract No. LI362-05. (Unpublished study received Apr 3, 1980 under
             1529-EX-2; prepared by Syracuse Research Corp.,  submitted by GAP Corp.,
             Chemical Div.,  New York, N.Y.; CDL:099355-E)
                                       107
-------
                               BIBLIOGRAPHY
MRID
CITATION
00029509     Griffiths, J.T.; Parent, R.A. (1979) The Approximate Acute Oral Toxicity
             (LD50) of GAP CPD 71921/L9 in Male Sprague-Dawley Rats: Laboratory No.
             2-6153.  (Unpublished study received Apr 3, 1980 under 1529-EX-2; prepared
             by Food and Drug Research Laboratories, Inc., submitted by GAP Corp.,
             Chemical Div., New York, N.Y.; CDL:099356-A)

00029510     Deprospo, J.R. (1975) Acute Dermal LD50 Test in Rabbits: Contract No.
             120-2544-35.  (Unpublished study received Apr 3, 1980 under 1529-EX-2;
             prepared by Affiliated Medical Research, Inc., submitted by GAP Corp.,
             Chemical Div., New York, N.Y.; CDL: 099356-B)

00029513     Stevens, K.R. (1979) Primary Skin Irritation Study with Rabbits: Laboratory
             No. 6153.  (Unpublished study received Apr 3, 1980 under 1529-EX-2;
             prepared by Food and Drug Research Laboratories, Inc., submitted by  GAP
             Corp., Chemical Div., New York, N.Y.; CDL:099356-E)

00030190     Hegidio, J.; Dyson, D.; Thomas, N.B.; et al. (1979) Residues.  Includes
             method dated Oct 1979.  (Unpublished study received Dec 19, 1979 under
             264-267; prepared in cooperation with Salyer Land Co. and others, submitted
             by Union Carbide Agricultural Products Co., Ambler, Pa.; CDL:099158-C)

00032573     Harrison, S.L.; Nygren, R.E.; Gross, S.M.; et al. (1980) Residues: Ethrel(R)
             Sugarcane: Project No. 10223.  (Unpublished study received May 15, 1980
             under 264-EX-59; prepared in cooperation with Hawaiian Sugar Planters'
             Association, submitted by Union Carbide Agricultural Products Co., Ambler,
             Pa.;CDL:099427-A)

00036500     Obenauf, G.L. (1973) Residues: Ethephon. (Unpublished study received Mar
             19,  1974 under 4F1490; prepared in cooperation with Greenwood Laboratories,
             Inc., submitted by Union Carbide Agricultural Products Co., Ambler, Pa.;
             CDL:093944-B)

00036510     Reese, W.H., Jr. (1972) Final Report-Phase H: Evaluation of Ethrel in Human
             Volunteers: BRL Project No. 7223. (Unpublished study received on unknown
             date under 4F1490; prepared by Litton Industries, submitted by Union  Carbide
             Agricultural Products Co., Ambler, Pa.; CDL:093946-D)

00038793     Union Carbide Agricultural Products Company (1972) Metabolism: The Nature
             and Quantities of Residues and Metabolic Degradation Products Resulting from

                                        108
-------
                                BIBLIOGRAPHY
 MRID
                    CITATION
             the Treatment of Walnuts with Ethephon. (Unpublished study received Dec 20,
             1972 under 3F1344; CDL: 093599-C)
 00038795
 00038796
00038797
00038880
00038881
00040268
00040269
 Sibbett, S.; Hendricks, L.; Schraeder, W. (1972) Residues: Ethephon.
 (Unpublished study received Dec 20, 1972 under 3F1344; prepared in
 cooperation with Morse Laboratories, Inc., submitted by Union Carbide
 Agricultural Products Co., Ambler, Pa.; CDL:093599-E)

 Union Carbide Agricultural Products Company (1970) Metabolism: The Nature
 and Quantities of Residues and Metabolic Degredation Products Resulting from
 the Treatment of Filberts with Ethephon. (Unpublished study received Dec 20,
 1972 under 3F1344; CDL: 093599-F)

 Lagerstedt, H. (1972) Residues: Ethephon. (Unpublished study received Dec
 20, 1972 under 3F1344; prepared in cooperation with Oregon State Univ.,
 submitted by Union Carbide Agricultural Products Co., Ambler, Pa.-
 CDL:093599-G)

 Amchem Products, Incorporated (1972) Detailed Method of Analysis  for
 Residues of (2-Chloroethyl)phosphonic acid (Ethephon) in Walnuts. Method
 dated Nov 1972.  (Unpublished study received Dec 20, 1972 under 3F1344;
 submitted by Union Carbide Agricultural Products Co., Ambler, Pa.-
 CDL:093596-A)

 Amchem Products, Incorporated (1972) Detailed Method of Analysis  for
 Residues of (2-Chlorethyl)phosphonic acid (Ethephon) in Filberts. Method
 dated Nov 1972.  (Unpublished study received Dec 20, 1972 under 3F1344;
 submitted by Union Carbide Agricultural Products Co., Ambler  Pa •
 CDL:093596-B)

 Union Carbide Agricultural Products Company (19??) Effect of Temperature on
 the Level of Ethephon Residue in Pineapple Shell. (Unpublished study received
 Aug 27, 1971 under 2G1195;  CDL: 095928-A)

 Union Carbide Agricultural Products Company (1970) Relevance of Laboratory
Branning Study to a Commercial Branning Operation. (Unpublished study
received Aug 27,  1971 under 2G1195; CDL: 095928-B)
                                        109
-------
                               BIBLIOGRAPHY
MRID
CITATION
00041465     Valenzuela, C.; Sarin, G.; Uribe, ?; et al. (1973) Residue: Ethephon.  Includes
             method dated Oct 1973.  (Unpublished study received on unknown date under
             4E1440; prepared in cooperation with Centre Agricola Valenzuela and
             Rorer—Hormoquimica, Ltda., submitted by Union Carbide Agricultural
             Products Co., Ambler, Pa.; CDL:093839-A)

00042977     Union Carbide Agricultural Products Company (19??) Analysis of Pineapple
             Tissue for Residues of 2-Chloroethylphosphonic acid. Undated method.
             (Unpublished study received Dec 23, 1969 under 264-257; CDL:100700-D)

00047911     Westwood,  M.; Anderson, J.L.; Edgerton, L.; et al. (1971) Validation of
             Analytical Method. (Unpublished study including letter dated Aug 4, 1971
             from S.L. Harrison to Richard J. Otten, received Jun 16, 1971 under 1G1172;
             prepared in cooperation with Oregon State Univ. and others, submitted by
             Union Carbide Agricultural Products Co., Ambler, Pa.; CDL:093494-A)

00047913     Amchem  Products, Incorporated (1971) Detailed Method of Analysis for
             Residues of 2-Chloroethylphosphonic acid (Ethephon) in Cherries.  Method
             dated May 1971.  (Unpublished  study received Jun 16, 1971 under 1 Gil72;
             submitted by Union Carbide Agricultural Products Co., Ambler, Pa.;
             CDL:093494-C)

00051353     Harrison, S.L. (1976) Letter sent to Warren A.  Davis dated Aug 20, 1976:
             Ethrel(TM)~Grapes: Ethephon Residues Resulting from Aerial Application.
             (Unpublished study received Sep 21, 1976 under 264-267; prepared in
             cooperation with San Joaquin Sulphur and San Joaquin Valley Agricultural
             Research  and Extension Center,  submitted by Union Carbide Agricultural
             Products Co., Inc., Ambler, Pa.; CDL:095290-H)

00053149     Amchem  Products, Incorporated (1976) Detailed Method of Analysis for
             Residues of (2-Chloroethyl) phosphonic acid (Ethephon) in Grapes, Grape
             Juice, Grape Wine and Dried Grape Pomace. Method dated Jul 1976.
             (Unpublished study received Sep 21, 1976 under 264-267; submitted by Union
             Carbide Agricultural Products Co., Inc.,  Ambler, Pa.; CDL:095290-E)

00053150     Amchem  Products, Incorporated (1976) Results  of Analyses of Grapes for
             Ethephon Residues. (Reports by various  sources; unpublished study received
             Sep 21, 1976 under 264-267; submitted by Union Carbide Agricultural
             Products Co., Inc., Ambler, Pa.; CDL: 095290-F)
-------
                                BIBLIOGRAPHY
 MRID
CITATION
00053153    Martin, G.C.; Weaver, R.J.; Abdel-Gawad, H.A. (19??) Translocation,
             Breakdown and Metabolic Fate of l,2-14C-(2-Chloroethyl) phosphonic acid in
             Grapes and Walnuts.  (Unpublished study received Sep 21, 1976 under
             264-267;  prepared by Univ. of California-Davis, Departments of Pomology and
             Viticulture & Enology, submitted by Union Carbide Agricultural Products Co.,
             Inc., Ambler, Pa.; CDL:095290-J)

00054013    Bentley, R.E. (1974) Acute Toxicity of Technical Ethrel to Grass Shrimp
             (Palaemonetes vulgaris), Mud Crab (Neopanope texana) Water Flea (Daphnia
             magna), Midge Larvae (Chironomus tentans), and Scud (Gammarus fasciatus).
             (Unpublished study received Dec 5, 1974 under 264-292; prepared by
             Bionomics, EG&G, Inc., submitted by Union Carbide Agricultural Products
             Co., Inc., Ambler,  Pa.; CDL:230425-R)

00054018    Yamaguchi, M.; Chu, C.W.; Yang, S.F. (1971) Metabolism of Ethephon in
             Tomatoes. (Unpublished study received Jun 7, 1972 under 2G1195; prepared
             by Univ.  of California-Davis, Dept. of Vegetable Crops, submitted by Union
             Carbide Agricultural Products Co., Inc., Ambler, Pa.;  CDL:091010-B)

00054021    Union Carbide Agricultural Products Company, Incorporated (1969)
             2-Chloroethylphosphonic acid (Ethephon),!, 2-C14 Metabolism Study.
             (Unpublished study received Jun 7, 1972 under 2G1195; CDL:091010-E)

00054022    Union Carbide Agricultural Products Company, Incorporated (1970) Residues:
             Ethrel in Pineapples. (Reports by various sources; unpublished study received
             Jun 7, 1972 under 2G1195; CDL: 091010-F)

00056480    Hinkle, S.; Cameron, J.T. (1979) Final Report: Avian Dietary Toxicity (LC50)
             Study in Mallard Ducks: Project No. 257-107.  (Unpublished study received
             Apr 3,  1980 under 1529-EX-2; prepared by Hazleton Laboratories America,
             Inc., submitted by GAP Corp., Chemical Div., New York, N.Y.;
             CDL:099355-C)

00060359    Reno, F.E.; Voelker, R.W. (1977) Final Report: A Two-Year Dietary Study in
             Dogs: Project No. 141-260. (Unpublished study received Aug 30, 1978 under
             264-267; prepared by Hazleton Laboratories America, Inc., submitted by Union
             Carbide Agricultural Products Co., Inc., Ambler, Pa.; CDL:235115-A)
                                        111
-------
                               BIBLIOGRAPHY
MRID
CITATION
00061717     Union Carbide Agricultural Products Company, Incorporated (1976) Ethephon
             Analyses: Ethrel(TM)-Treated Apples.  (Reports by various sources;
             unpublished study, including letter dated Aug 11, 1976 from S.L. Harrison to
             W.A. Davis, received Sep 21, 1976 under 264-267; CDL:228350-B)

00061719     Union Carbide Agricultural Products Company, Incorporated (1976) Ethephon
             Analyses: Peppers Treated Aerially with Ethrel(TM). (Reports by various
             sources; unpublished study, including letter dated Aug 30,  1976 from S.L.
             Harrison to W.A. Davis, received Sep 21, 1976 under 264-267;
             CDL:228351-B)

00063745     Rodwell, D.E.; Spencer, A.G.; Allen, S.; et al.  (1980) Teratology Study in
             Rats: IRDC No. 369-042. (Unpublished study received Dec 1, 1980 under
             264-267; prepared by International Research and Development Corp.,
             submitted by Union Carbide Agricultural Products Co., Inc., Ambler, Pa.;
             CDL:099767-A)

00066931     Weir, R.J. (1977) Final Report: Evaluation of Ethephon in Human Volunteers:
             LBI Project No. 2416.  (Unpublished study received Aug 30, 1978 under
             264-267; prepared by Litton Bionetics, Inc., submitted by Union Carbide
             Agricultural Products Co., Inc., Ambler, Pa.; CDL:235116-A)

00067489     Abdel-Gawad, H.A.; Martin, G.C. (1973) The fate of
             l,2-14C-(2Chloroethyl)phosphonic acid (Ethephon) in peach. Hortscience
             8(2): 125-126. (Also In unpublished submission received Jan 5, 1981 under
             1529-EX-2; submitted by GAP Corp., Chemical Div., New York, N.Y.;
             CDL:099880-E)

00080482     Harrison, S.L. (1979) Letter sent to Warren A. Davis dated Feb 9,  1979:
             Residues of Ethephon in Grapes and Related Foods and Feeds.  (Unpublished
             study received Mar 2, 1979 under 264-267; submitted by Union Carbide
             Agricultural Products Co., Inc., Ambler, Pa.; CDL:097830-G)

00081782     Union Carbide Agricultural Products Company,  Incorporated (1971) Residues:
             Ethephon. (Unpublished study received May 7,  1971  under 1G1172;
             CDL:090971-D)

00081783     Edgerton,  L.J.; Hatch, A.H. (1970) Metabolism of
             14C-2-Chloroethylphosphonic Acid in Cherries.  (Unpublished study, including

                                        112
-------
                                BIBLIOGRAPHY
 MRID
                    CITATION
             submitter summary, received May 7, 1971 under 1 Gil72; prepared by Cornell
             Univ., submitted by Union Carbide Agricultural Products Co., Inc., Ambler,
             Pa.;CDL:090971-G)
00083773
00085446
00085755
00088983
00097422
00100517
00103287
 Huhtanen, K.; Parkins, M.D.; Heintzelman, R.W. (1981) Analysis of Cow
 Tissues for Possible Residues of Monochloroacetic Acid. (Unpublished study
 received May 28, 1981  under 264-267; submitted by Union Carbide
 Agricultural Products Co., Inc., Ambler, Pa.; CDL:070122-A)

 Fink, R.; Beavers, J.B.; Brown, R. (1977) Final Report: Eight-day Dietary
 LC50--Bobwhite Quail: Project No. 113-139. (Unpublished study received
 Mar 2,  1979 under 264-267; prepared by Wildlife International, Ltd.  and
 Washington College, submitted by Union Carbide Agricultural Products Co.,
 Inc., Ambler, Pa.; CDL:097830-F)

 Weatherholtz, W.M.; Mistretta, L.H.; Wolfe, G.W.; et al. (1981) Teratology
 Study in Rabbits: Technical Ethephon: Project No. 400-635.  Final rept.
 (Unpublished study received Oct 19, 1981 under 264-267; prepared by
 Hazleton Laboratories America, Inc., submitted by Union Carbide Agricultural
 Products Co., Inc., Ambler, Pa.; CDL:246064-B)

 Heintzelman, R.W.; Madgwick, G.G. (1981) A Review of the Metabolism of
 2-Chloroethylphosphonic Acid (Ethephon): Project No. 866C51. (Unpublished
 study received Dec 22,  1981 under 264-EX-62;  submitted by Union Carbide
 Agricultural Products Co., Inc., Ambler, Pa.; CDL:070579-C)

 Harrison, S.L. (1974) Letter sent to R.J. Otten dated Mar 19, 1974:
 Metabolism of ethephon in figs. (Unpublished study received Mar 19, 1974
 under 4F1490; submitted by Union Carbide Agricultural Products Co., Inc.,
 Ambler, Pa.; CDL:093944-A)

 Huhtanen, K.L.; Heintzelman, R.W. (1982) Ethephon Residue Transfer to
 Meat and Milk in Cows: File No. 30081.  (Unpublished study received Apr 20,
 1982 under 264-257; submitted by Union Carbide Agricultural Products Co.,
Inc., Ambler, Pa.; CDL: 070813-A)

Harrison, S.; Madgwick, G. (1982) Residues of Ethephon in Wheat, Barley and
Oats Resulting from Application of Ethrel as an  Anti-lodging Agent: File No.
30263.  (Unpublished study received Jun 17, 1982 under 264^376;  submitted by

                           113
-------
                               BIBLIOGRAPHY
MRID
CITATION
             Union Carbide Agricultural Products Co., Inc., Research Triangle Park, NC;
             CDL: 070929-D)

00107428     Fink, R.; Reno, F. (1974) Final Report: Eight-day Dietary LC50-Mallard
             Ducks: CPGR: Project No. 257-102.  (Unpublished study received Mar 15,
             1974 under 1529-20; prepared by Truslow Farms, Inc., and Environmental
             Sciences Corp., submitted by GAP Corp., Chemical Div., New York, NY;
             CDL:132053-A)

00108992     Fritz, D.; Barden, J.; Edgerton, L. (1971) Residues: Ethepon in Apples.
             (Unpublished study received Jul 15, 1972 under 2G1217; prepared in
             cooperation with Virginia Polytechnic Institute and Cornell Univ., submitted by
             Amchem Products, Inc., Ambler,  PA; CDL:091045-A)

00108993     Edgerton, L.; Hatch, A. (1969) Metabolism of 14C-2-Chloroethylphosphonic
             Acid in Apples.  (Unpublished study received Jul 15, 1972 under 2G1217;
             prepared by Cornell Univ., submitted by Amchem Products, Inc., Ambler, PA;
             CDL:091045-B)

00116123     Amchem Products, Inc. (1970) Residue and Metabolism: Ethephon in
             Pineapples.  (Compilation; unpublished study received  Jul 30, 1970 under
             1F1016; CDL:091065-A)

00117752     Amchem Products, Inc. (1971) Ethephon: Residues in Walnuts, Grapes, and
             Rats. (Compilation; unpublished study received May 5, 1971 under  1 Gil67;
             CDL:090965-B)

00117893     Amchem Products, Inc. (1972) Metabolism and Residue Data: Ethephon in
             Cantaloupes,  Grapes, Raisins. (Compilation; unpublished study received Oct 7,
             1972 under 2F1275; CDL:091811-A)

00118508     Chib, J.; Heintzelman,  R. (1982)  Ethephon, 2-Chloroethylphosphonic Acid,
             Metabolism in Lactating Goat: File No. 30388. (Unpublished study  received
             Dec 17, 1982 under 2F2711; submitted by Union Carbide Agricultural Products
             Co., Inc., Research Triangle Park, NC; CDL:071263-A)

00121613     Union Carbide Agricultural Products  Co., Inc. (1974)  Ethephon Residue in
             Cranberries & Tomatoes. (Compilation; unpublished study received Jul 2,
             1974 under 5F1524; CDL:094038-A; 094039)

                                        114
-------
                                BIBLIOGRAPHY
 MRID
CITATION
00122410    Union Carbide Agricultural Prodcts Co., Inc. (1974) Residue and Metabolism
             Data: Ethephon in Tobacco.  (Compilation; unpublished study received Dec 5,
             1974 under 264-292; CDL:028295-A)

00122412    Sleight, B. (1971) The Acute Toxicity of Ethrel to Bluegill ... and ... Salmo
             gairdneri.  (Unpublished study received Dec 5, 1974 under 264-292; prepared
             by Bionomics, Inc., submitted by Union Carbide Agricultural Products Co.,
             Inc., Research Triangle Park, NC; CDL:028299-B)

00122414    Fink, R. (1972) Eight-day Dietary LC50--Mallard Ducks: Ethephon: Project
             No. 141-246. Final rept.  (Unpublished study received Dec 5, 1974 under
             264-292; prepared by Hazleton Laboratories, Inc., submitted by Union Carbide
             Agricultural Products Co., Inc., Research Triangle Park, NC; CDL:028299-D)

00122421    Union Carbide Agricultural Products Co., Inc. (1973) Residues: Ethrel in
             Various Crops and Chicken Tissues. (Compilation; unpublished study received
             1973 under 2F1275; CDL:095926-C)

00122423    Gross,  S.;  Scott, A.; Smith,  T.; et al. (1978) Residues of Ethrel in Cotton
             Seed, Oil and Meal: Document No. 378A3.  (Unpublished study received Mar
             16, 1978 under 264-EX-55; prepared in cooperation with Rio Farms and
             others,  submitted by Union Carbide Agricultural Products Co., Inc., Research
             Triangle Park, NC; CDL:096972-B)

00122429    Interregional Research Project No. 4 (1976)  The Results of Tests on the
             Amount of Ethephon Residues Remaining in or on Cucumbers Including a
             Description of the Analytical Method Used.  (Compilation; unpublished study
             received Jun 20, 1979 under 9E2225;  CDL: 098344-A)

00122433    Amchem Products, Inc.  (1970) Detailed Method of Analysis for Residues of
             2-Chloroethylphosphonic Acid (Ethephon) in Pineapples.  (Unpublished study
             received 1970 under 1F1016; submitted  by Union Carbide Agricultural
             Products Co., Inc., Research Triangle Park, NC; CDL:098469-A)

00122435    Union Carbide Agricultural Products Co., Inc. (1974) Ethephon Residue in
             Grapes  and Related Items.  (Compilation; unpublished study received 1974
             under 5F1524; CDL:098573-B)
                                        115
-------
                               BIBLIOGRAPHY
MRID
CITATION
00122448     Pitcher, F. (1974) Cepha-Daphnia magna: Test No. 672. (Unpublished study
             received Mar 13, 1974 under 1529-20; prepared by Pesticides Regulation Div.,
             Animal Biology Laboratory, submitted by U.S. Environmental Protection
             Agency, Beltsville, MD; CDL: 132055-A)

00122452     Union Carbide Agricultural Products Co., Inc. (1975) Residues: Ethrel-treated
             Pineapples. (Compilation; unpublished study received Sep 4, 1975 under
             264-257; CDL:221823-B)

00122717     Union Carbide Agricultural Products Co., Inc. (1981) The Results of Tests on
             the Amount of Ethephon Residues Remaining in or on Pumpkins.
             (Compilation; unpublished study received Dec 21, 1982 under 264-263;
             CDL:071299-A)

00123222     Union Carbide Agricultural Products Co., Inc. (1972) Ethephon: Residues in
             Apples and Other Subjects. (Compilation; unpublished study received Oct 24,
             1972 under 3F1325; CDL:093555-B)

00123237     Union Carbide Agricultural Products Co., Inc. (1973) Detailed Method of
             Analysis for Residues of ... Ethephon in Cranberries. (Compilation;
             unpublished study received Feb 5,  1973 under 3F1353; CDL:093617-A)

00128726     Interregional Research Project No. 4 (1975) The Results of Tests on the
             Amount of Ethephon Residues Remaining in or on Macadamia Nuts, Including
             a Description of the Analytical Method Used. (Unpublished study received Jun
             10,  1983 under 3E2909; CDL: 071698-A)

00136287     Amchem Products, Inc. (1972) Residues: Ethephon.  (Compilation; unpublished
             study received Oct 3,  1972 under 3F1321; CDL: 092129-B)

00141506     Heintzelman, R. (1984) Ethephon Goat Metabolism: V5007.  Unpublished
             study prepared by Union Carbide Agricultural Products Co., Inc. lip.

00142265     Huhtanen, K. (1984) Cerone: Detailed Methods of Analysis for Residue of
             (2-Chloroethyl) Phosphonic Acid (Ethephon) in Milk and Cow Liver, Muscle,
             Kidney and Fat Tissues: Project Number: 866R10. Unpublished study prepared
             by Union Carbide Agricultural Products Co., Inc.  20 p.
                                        116
-------
                                BIBLIOGRAPHY
MRID
CITATION
00144559    Fletcher, D. (1983) 42-Day Neurotoxicity Study with Ethephon:Base 250 in
             Mature White Leghorn Chickens: BLAL No. 83 DN 102.  Unpublished study
             prepared by Bio-Life Assoc., Ltd. 52 p.

00145613    Union Carbide Agricultural Products Co. (1984?) Residue Summary: Ethephon
             Residue Data.  Unpublished compilation. 59 p.

00147357    Weatherholtz, W. (1984) Two Year Dietary Study in Dogs: Ethrel: Addendum
             to Final Report: Project No.  141-260. Unpublished study prepared by Hazleton
             Laboratories America, Inc. 5 p.

00151127    Union Carbide Agricultural Products Co. Inc. (1985) Residues of Ethephon in
             Sugarcane and Rotational Crops.  Unpublished compilation.  11 p.

00165339    Huhtanen, K.; Storm, J.; Heintzelman, R. (1984) Ethrel: Metabolism of
             Carbon 14-ethephon in Lactating Goats:  Project No. 866R10: File No. 32452.
             Unpublished study prepared by Union Carbide Agricultural Products Co., Inc.
             39 p.

40412401    Jagannath, D. (1987) Mutagenicity Test on Ethephon Base 250 in the Ames
             Salmonella/Microsome Reverse Mutation Assay: HLA Study No.:
             10065-0-401.  Unpublished study prepared by Hazleton Laboratories America,
             Inc.  33 p.

40555201    Cifone, M. (1988) Mutagenicity Test on Ethepon in the Rat Primary
             Hepatocyte Unscheduled DNA Synthesis Assay: HLA Study No. 10065-0-447.
             Unpublished study prepared by Hazleton Laboratories America, Inc. 31 p.

40555301    Murli, H. (1988) Mutagenicity Test on Ethephon Base 250 in an in vitro
             Cytogenetic Assay Measuring Chromosomal Aberration Frequencies in Chinese
             Hamster Ovary (CHO) Cells: HLA Study No. 10065-0-437.  Unpublished study
             prepared by Hazleton Laboratories America, Inc.  33 p.

40954401    Nygren, R. (1988) Ethephon Residues in Mill Fractions of Treated Sugarcane:
             Project No. 866R10: File No. 40289.  Unpublished study prepared by
             Rhone-Poulenc Ag Co.  54 p.
                                        117
-------
                               BIBLIOGRAPHY
MRID
CITATION
41050801     Van Miller, J. (1988) Lifetime Dietary Oncogenicity Study with Ethephon in
             Alnino Mice:  Laboratory Project ID: 51-502.  Unpublished study prepared by
             Bushy Run Research Center.  1347 p.

41103001     Henwood, S. (1989) Teratology Study with Ethephon Technical Base 250 in
             Rats: Proj. ID HLA 6224-125. Unpublished study prepared by Hazleton
             Laboratories America, Inc.  286 p.

41135001     Hamada, N. (1989) One-Year Oral Toxicity Study in Beagle Dogs with
             Ethephon: Final Report: HLA Study No. 400-722.  Unpublished study prepared
             by Hazleton Laboratories America, Inc. 557 p.

41139001     Van Miller, J. (1989) Lifetime Dietary Combined Chronic Toxicity and
             Oncogenicity Study with Ethephon in Albino Rats: Laboratory Project ID:
             51-501.  Unpublished study prepared by Union Carbide, Bushy Run Research
             Center.  2427 p.

41154503     Rush, R. (1989) Dermal Sensitization Study in Guinea Pigs with Base A-250:
             Final Report: SLS Study No. 3147.44.  Unpublished study prepared by
             Springborn Life Sciences, Inc. 32 p.

41154505     Helfant, L.; Castillo, M. (1989) Ethephon Manufacturing Use Product Base
             250: Product Indentity and Composition: Unpublished compilation prepared by
             Rhone-Poulenc Ag Co.  96  p.

41154506    Helfant, L. (1989) Ethephon Manufacturing Use Product Base 250: Physical
             and Chemical Characteristics: Project No. 866/C10. Unpublished Compilation
             prepared by Rhone-Poulenc Ag Co.  214 p.

41267001     Helfant, L. (1989) Ethephon Manufacturing Use Product: Base 250: Analysis
             and Certification of Product Ingredients: Laboratory Project No. 866 CIO:
             Study No. AC-89-005. Unpublished study prepared by Rhone-Poulenc AG Co.
             in cooperation with Lancaster Laboratories, Inc. 321 p.

41295901     Henwood, S. (1989) 3-Week Dermal Toxicity Study with Ethephon Technical
             in Rabbits:  Lab Project Number: HLA/6224/141. Unpublished study prepared
             by Hazleton Laboratories America, Inc. 247 p.
                                         118
-------
                                BIBLIOGRAPHY
MRID
CITATION
41296201     Rhoads, W. (1988) Determination of the Characteristics of Ethephon When
             Subjected to Analysis by the United States Food and Drug Administration
             (FDA) Multi-residue Protocols I, H, IE and IV: Rhone Poulenc Report 1087A.
             Unpublished study prepared by Colorado Analytical Research & Development
             Corp.  142 p.

41296202     Dionne, E. (1989) Ethephon-Acute Toxicity to Eastern Oyster (Crassostrea
             virginica) under Flow-through Conditions: Final: SLI Report No. 89-10-3121;
             SLI Study 10566.1288.6123.504. Unpublished study prepared by Springborn
             Laboratories, Inc., Environmental Sciences Div. 37 p.

41403301     Giddings, J. (1990) Ethephon-Toxicity to the Marine Diatom Skeletonema
             costatum: Lab Project Number: 90-1-3207: 10566-0389-6131450. Unpublished
             study prepared by Springborn Laboratories, Inc. 36 p.

41403302     Giddings, J. (1990) Ethephon-Toxicity to the Freshwater Diatom Navicula
             pelliculosa: Lab Project Number: 90-2-3234: 10566-03896131-440.
             Unpublished study prepared by Springborn Laboratories Inc.  36 p.

41403303     Giddings, J. (1990) Ethephon-Toxicity to the Freshwater Bluegreen Alga
             Anabaena flos-aquae: Lab Project Number: 90-1-3206: 105660389-6131-420.
             Unpublished study prepared by Springborn Laboratories, Inc.  35 p.

41403304     Giddings, J. (1990) Ethephon-Toxicity to the Freshwater Green Alga
             Selenastrum capricornutum: Lab Project Number: 90-1-3197:
             105660389-6131-430.  Unpublished study prepared by Springborn
             Laboratories, Inc. 36 p.

41403305     Hoberg, J. (1990) Ethephon-Determination of Effects on Seedling
             Germination, Shoot Emergence and Seedling Vigor of Ten Plant Species: Lab
             Project Number: 90-2-3220: 10566-1288-6124-610. Unpublished study
             prepared by Springborn Laboratories, Inc.  311 p.

41508701     Neeper-Bradley, T.; Tyl, R. (1990) Two-generation Reproduction Study in CD
             Albino Rats exposed to Ethephon by  Dietary Inclusion: Lab Project I.D.:
             51-539. Unpublished study prepared by Union Carbide Bushy Run Research
             Center.  760 p.
                                        119
-------
                                BIBLIOGRAPHY
MRID
CITATION
41509001     Giddings, J. (1990) Ethephon-Toxicity to the Freshwater Plant Lemna gibba
             G3: Final Report: SLI Report No.: 90-04-3302; SLI Study No.:
             10566.0389.6131.410.  Unpublished study prepared by Springborn
             Laboratories, Inc., Environmental Sciences Div.  42 p.

41545601     Das, Y. (1990) Photodegradation of Ethyl(U)-carbon HEthephon in Aqueous
             Solution Buffered at pH 5 under Sunlight: Lab Project Number: 89151.
             Unpublished study prepared by Innovative Scientific Services, Inc. 95 p.

41545701     Das, Y. (1990) Hydrolysis of Ethyl(U)-carbon HEthephon in Aqueous
             Solutions Buffered at pH 5, 7 and 9: Lab Project Number: 89150.  Unpublished
             study prepared by Innovative Scientific Services, Inc. 113 p.

41557201     Kenwood, S. (1990) Teratology  Study with Ethephon Technical-Base 50 in
             Rabbits: Lab Project I.D.:  HLA 6224-158.  Unpublished study prepared by
             Hazleton Laboratories America,  Inc. 166 p.

41659401     Hoberg, J.  (1990) Ethephon-Supplemental  Report: Determination of Effects on
             Carrot and  Ryegrass Emergence and Carrot Seedling Vegetative Vigor: Lab
             Project Nos.: 90-3-3244: 10566-12886124-610.  Unpublished study prepared by
             Springborn Labs., Inc. 107 p.

41668201     Eckert, J. (1990) Ethephon-Plant Regulator: Storage Stability Study in Wheat
             Grain: Interim Report: Lab Project Number: RP-01-891. Unpublished study
             prepared by Enviro-Bio-Tech, Ltd.  29 p.

41668202    Eckert, J. (1990) Ethephon-Plant Regulator: Storage Stability Study in Wheat
             Straw: Interim Report: Lab Project Number: RP-01-89H. Unpublished study
             prepared by Enviro-Bio-Tech, Ltd.  29 p.

41668203    Eckert, J. (1990) Ethephon-Plant Regulator: Storage Stability in Apples:
             Interim Report: Lab Project Number: RP-01-89C. Unpublished study prepared
             by Enviro-Bio-Tech, Ltd.  33 p.

41668204    Eckert, J. (1990) Ethephon-Plant Regulator: Storage Stability Study in
             Blackberries: Interim Report: Lab Project Number: RP-01-89B. Unpublished
             study prepared by Enviro-Bio-Tech, Ltd. 33 p.
                                         120
-------
                                BIBLIOGRAPHY
 MRID
                    CITATION
 41668205
 41668206
41668207
41668208
41668209
41668210
41668211
41668212
41668213
 Nygren, R. (1990) Ethephon-Plant Regulator: Residues in Blackberries: Lab
 Project Number: USA89E41: 40843.  Unpublished study prepared by
 Rhone-Poulenc Ag Co., in cooperation with McKenzie Laboratories, Inc., and
 Others.  96 p.

 Eckert, J. (1990) Ethephon-Plant Regulator: Storage Stability Study in
 Cantaloupe: Interim Report: Lab Project Number: RP-01-89G. Unpublished
 study prepared by Enviro-Bio-Tech, Ltd.  34 p.

 Nygren, R. (1990) Ethephon-Plant Regulator: Residues in Cantaloupe: Lab
 Project Number: USA89E42: 40844. Unpublished study prepared by
 Rhone-Poulenc Ag Co., in cooperation with McKenzie Labs and others.  95 p.

 Nygren, R. (1990) Storage Stability Study of Ethephon in/on Whole Fresh
 Cherries: Interim Report:  Lab Project Number: 89-REN-CH-S: 40836.
 Unpublished study prepared by Rhone-Poulenc Ag Co. 24 p.

 Eckert, J. (1990) Ethephon-Plant Regulator: Storage Stability Study in Grapes:
 Interim Report: Lab Project Number: RP-01-89D.  Unpublished study prepared
 by Enviro-Bio-Tech, Ltd.   33 p.

 Nygren, R. (1990) Ethephon-Storage Stability Study in/on Whole Fresh
 Peppers: Interim Report: Lab Project Number: 89-REN-P-S: 40845.
 Unpublished study prepared by Rhone-Poulenc Ag Co. 24 p.

 Eckert, J. (1990) Ethephon-Plant Regulator: Storage Stability Study in
 Tomatoes: Interim Report: Lab Project Number: RP-01-89A. Unpublished
 study prepared by Enviro-Bio-Tech, Ltd.  33 p.

 Nygren, R. (1990) Storage Stability of Ethephon in/on Walnut Nutmeats:
Interim Report: Lab Project Number: 89-REN-WA-S:  40848.  Unpublished
 study prepared by Rhone-Poulenc Ag Co.  20 p.

Eckert, J. (1990) Ethephon-Plant Regulator: Storage Stability Study in
Pineapple Fruit: Interim Report:  Lab Project Number:  RP-01-89E.
Unpublished study prepared by Enviro-Bio-Tech, Ltd.  33 p.
                                        121
-------
                               BIBLIOGRAPHY
MRID
CITATION
41668215     Eckert, J. (1990) Ethephon-Plant Regulator: Storage Stability Study in
             Cottonseed: Lab Project Number: RP-01-89J. Unpublished study prepared by
             Enviro-Bio-Tech, Ltd.  29 p.

41681401     Das, Y. (1990) Photodegration of Ethyl(U)-carbon 14Ethephon on Soil Under
             Artificial Sunlight: Lab Project Number: 90032.  Unpublished study prepared
             by Innovative Scientific, Inc.  106 p.

41685901     Nachreiner, D.; Klonne, D. (1989) Addendum to Inhalation Study for Base 250
             Ethephon: Lab  Project Number: 52-580.  Unpublished study prepared by Bushy
             Run Research Laboratories.  13 p.

41704501     Nygren, R.  (1990) Prep/Cotton/Residues: Lab Project No: USA89I03: 40859.
             Unpublished study prepared by Rhone Poulenc Ag Co., inn cooperation with
             McKenzie Laboratories, Inc.  299 p.

41746501     Johnson, T. (1991) A Tobacco Pyrolysis Study with carbon 14-Ethephon Using
             Flue Cured  Tobacco (Nicontiana tabacum): Lab Project Number: 1299:  446.
             Unpublished study prepared by PTRL East, Inc. 59 p.

41757701     Das, Y. (1991) Metabolism of Ethyl(U)-carbon 14Ethephon Under Aerobic Soil
             Conditions:  Lab Project Number: EC-90-111: 90031. Unpublished study
             prepared by Innovative Scientific Services, Inc.  82 p.

41757702     Das, Y. (1991) Metabolism of Ethyl(U)-carbon 14Ethephon Under Anaerobic
             Aquatic Soil Conditions: Lab Project No: EC-90-112. Unpublished study
             prepared by Innovative Scientific Services, Inc.  92 p.

41872501     Nygren, R.  (1990) Ethrel/Grape/Residue: Lab Project Nos: USA89E25; 40869.
             Unpublished study prepared by Rhone-Poulenc Ag Co., in cooperation with
             Mckenzie Laboratories, Inc.  141 p.

41872502     Nygren, R.  (1990) Ethrel Apple 1989 Residue Program: Lab Project Nos:
             USA89E32; 40891.  Unpublished study prepared by RhonePoulenc Ag Co., in
             cooperation with Mckenzie Laboratories, Inc. 150 p.

41906101     Savage, E.; (1990) Carbon 14-Ethephon: Absorption, Distribution,
             Metabolism, and Excretion in the Rat: Lab Project No: RP P89/ 366.
             Unpublished study prepared by Hazleton, UK. 626 p.

                                        122
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                                BIBLIOGRAPHY
 MRID
                    CITATION
 42010401
 42011501
42016701
42116501
42126001
42236701
42268901
42268902
 Nygren, R. (1991) Storage Stability of Ethephon in/on Walnut Nutmeats: Lab
 Project Number: 89-REN-WA-S: 41007. Unpublished study prepared by
 Rhone-Poulenc Ag Co.  34 p.

 Norris, F. (1991) A Terrestrial Field Soil Dissipation Study with Ethephon:
 Lab Project Number: EC-89-070: R092-079: R094-052. Unpublished study
 prepared by Rhone-Poulenc Ag Co., A & L Eastern Agriculteral Labs and A &
 L Western Agriculteral Labs. 250 p.

 Nygren, R. (1991) Ethrel Tomato Residues: Lab Project Number: USA89E30:
 40941.  Unpublished study prepared by Rhone-Poulenc Ag Co. and McKenzie
 Labs, Inc. 246 p.

 Nygren, R. (1991) Ethrel: Magnitude of the Residue/Crop Field Trials on
 Grapes: Amended Report: Lab Project Number: USA89E25: 41024.
 Unpublished study prepared by Rhone Poulenc Ag Co. in coop with McKenzie
 Labs, Inc., Cal State Univ., Viticulture and Enology Research Ctr. and others
 182 p.

 Das, Y. (1991) Soil Adsorption and Desorption of carbon 14 Ethephon: Lab
 Project Number:  ISSI 91020: EC-91-166. Unpublished study prepared by
 Innovative Scientific Services, Inc. 182 p .

 Byrd, J. (1992) A Metabolism Study with carbon 14 Ethephon in Laying Hens
 (Callus gallus): Lab Project Number: 9015C. Unpublished study prepared by
 Southwest Bio-Labs, Inc.  284 p.

 Conn, R. (1992) Magnitude of the Residue of Ethephon in the Processed
 Fractions of Wheat: Lab Project Number: SARS-89-2A-24P:
 SARS-90-TX-24P: MKL-001-90-02. Unpublished study prepared by Stewart
 Agricultural Research Services, Inc., The Texas A&M Univ. System, and
 McKenzie Laboratories, Inc. 164 p.

 Conn, R. (1992) Magnitude of the Residue of Ethephon and Monochloroacetic
Acid (MCAA)  in or on Wheat: SARS-89-24: MKL-001-90-02: SPRA-90-100.
Unpublished study prepared by Stewart Agricultural Research Services, Inc.,
Rhone-Poulenc Ag Co., and McKenzie Laboratories, Inc. 330 p.
                                        123
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                               BIBLIOGRAPHY
MRID
CITATION
42268903     Nygren, R. (1992) Ethrel: Tomato Magnitude of Residue Study: Lab Project
             Number: USA90E16: 41067. Unpublished study prepared by Rhone-Poulenc
             Ag Co., McKenzie Laboratories, Inc., and Glades Crop Care, Inc.  137 p.

42268904     Upalawanna, S. (1992) Storage Stability of Monochloroacetic Acid (MCAA)
             on Cottonseed: Lab Project Number: EC-90-133.  Unpublished study prepared
             by Rhone-Poulenc Ag Co.  45 p.

42268905     Upalawanna, S. (1992) Storage Stability of Monochloroacetic Acid (MCAA)
             on Grapes and Raisin Waste: Lab Project Number: EC-90-136.  Unpublished
             study prepared by Rhone-Poulenc Ag Co.  56 p.

42268906     Upalawanna, S. (1992)  Storage Stability of Monochloroacetic Acid (MCAA)
             on Wheat Straw: Lab Project Number: EC-90-135.  Unpublished study
             prepared by Rhone-Poulenc Ag Co.  49 p.

42268907     Upalawanna, S. (1992)  Storage Stability of Monochloroacetic Acid (MCAA)
             on Tomatoes:  Lab Project Number: EC-90-134. Unpublished study prepared
             by Rhone-Poulenc Ag Co.  41 p.

42268908     Upalawanna, S. (1992) Storage Stability of Monochloroacetic Acid (MCAA)
             on Cantaloupes:  Lab Project Number: EC-90-138. Unpublished study
             prepared by Rhone-Poulenc Ag Co.  41 p.

42268909     Upalawanna, S. (1992) Storage Stability of Monochloroacetic Acid (MCAA)
             on Blackberries: Lab Project: EC-90-137.  Unpublished study prepared by
             Rhone-Poulenc Ag Co.  42 p.

42294501     Putt, A. (1992) Ethephon Technical-The Chronic Toxicity to Daphnia magna
             Under Flow-through Conditions: Final Report: Lab Project Number:
             92-1-4074: 10566.0891.6210.130.  Unpublished study prepared by  Springborn
             Labs., Inc. 98 p.

42298201     Nygren, R. (1992) Ethrel/Pineapple/Residue Magnitude of the Residue Crop
             Trials and Processing Fractions:  Lab Project Number: USA89E27.
             Unpublished study prepared by Rhone-Poulenc Ag Co., Maui Pineapple Co.
             Ltd., and Hawaiian  Sugar Planters Assoc.  291 p.
                                        124
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                                BIBLIOGRAPHY
 MRID
CITATION
 42300801    Nygren, R. (1992) Storage Stability Study of Ethephon in/on Whole Fresh
             Peppers: Lab Project Number: 89-REN-P-S. Unpublished study prepared by
             Rhone-Poulenc Ag Co.  45 p.

 42300802    Nygren, R. (1992) Storage Stability Study of Ethephon in/on Whole Fresh
             Cherries: Lab Project Number: 89-REN-CH-S. Unpublished study prepared by
             Rhone-Poulenc Ag Co.  42 p.

 42300803    Eckert, J. (1992) Determination of the Storage Stability of Ethephon in
             Pineapple Fruit: Lab Project Number: RP-01-89E. Unpublished study prepared
             by Enviro-Bio-Tech, Ltd.  57 p.

 42300804    Eckert, J. (1992) Determination of the Storage Stability of Ethephon in Apple
             Fruit: Lab Project Number: RP-01-89C. Unpublished study prepared by
             Enviro-Bio-Tech, Ltd. 57 p.

 42300805    Eckert, J. (1992) Determination of the Storage Stability of Ethephon in Grape
             Berries: Lab Project Number: RP-01-89D. Unpublished study prepared by
             Enviro-Bio-Tech, Ltd. 57 p.

 42300806    Eckert, J. (1992) Determination of the Storage Stability of Ethephon in Tomato
             Fruit: Lab Project Number: RP-01-89A. Unpublished study prepared by
             Enviro-Bio-Tech, Ltd. 57 p.

 42300807    Eckert, J. (1992) Determination of the Storage Stability of Ethephon in
             Blackberry Fruit: Lab Project Number: RP-01-89B. Unpublished study
             prepared by Enviro-Bio-Tech, Ltd.  57 p.

 42300808    Upalawanna, S. (1992) Storage Stability on Monochloroacetic Acid (MCAA)
             on Pineapples: Lab Project Number: EC-90-139.  Unpublished study prepared
             by Rhone-Poulenc Ag Co.  41 p.

42379101     Nygren, R. (1992) Chromatograms and Answers Raised in EPA Reviews for
             Ethephon use on Apples: Addendum to MRID No. 41872502: Lab Project
             Number: USA89E32: 40891.  Unpublished study prepared by McKenzie
             Laboratories, Inc.  194 p.

42381701     Nygren, R. (1992) Chromatograms and Answers Raised in EPA Reviews for
             Ethephon Use on Sugarcane: Addendum to MRID 40954401: Lab Project

                                        125
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                               BIBLIOGRAPHY
MRID
CITATION
             Number: 40289: R87-023-R01. Unpublished study prepared by Rhone-Poulenc
             Ag. Co. 62 p.

42410301     Nygren, R. (1992) Chromatograms and Answers Raised in EPA Reviews for
             Ethephon Use on Grapes: An Addendum: Lab Project Number: USA89E25:
             40869.  Unpublished study prepared by McKenzie Laboratories, Inc.  265 p.

42410401     Eckert, J. (1992) Determination of the Storage Stability of Ethephon in Wheat
             Straw: Lab Project Number: RP-01-89H. Unpublished study prepared by
             Enviro-Bio-Tech, Ltd.  51 p.

42410402     Eckert, J. (1992) Determination of the Storage Stability of Ethephon in
             Cottonseed: Lab Project Number: RP-01-89J. Unpublished study prepared by
             Enviro-Bio-Tech, Ltd.  52 p.

42410403     Eckert, J. (1992) Determination of the Storage Stability of Ethephon in Wheat
             Grain: Lab Project Number: RP-01-891. Unpublished study prepared by
             Enviro-Bio-Tech, Ltd.  52 p.

42430501     Helfant, L. (1992) Ethephon Base 250 Storage Stability Study: Lab Project
             Number:  AC-91-008: 41247.  Unpublished study prepared by Rhone Poulenc
             AgCo.  50 p.

42464401     Nygren, R. (1992) Ethrel Brand Plant Regulator: Walnut/Magnitude of the
             Residue:  Lab Project Number: USA91E29.  Unpublished study prepared by
             Rhone-Poulenc Ag Co. 99 p.

42718101     Eckert, J. (1993) Determination of the Storage Stability of Ethephon in
             Cantaloupe Fruit: Lab Project Number: RP-01-89G: 90070: EBT-241.00.
             Unpublished study prepared by Enviro-Bio-Tech, Ltd.  59 p.

42926301     Bernard, M. (1993) Product Chemistry: Manufacturing and Analytical Data for
             Ethephon Technical Concentrate. Unpublished study compiled by Cedar
             Chemical Corp. 31 p.

42957301    Leonard, M. (1993) Storage Stability of Ethephon in/on Frozen Bovine Meat,
             Bovine Milk and Chicken Eggs Spiked with Ethephon:  Lab Project Number:
             EC-92-198: 44198.  Unpublished study prepared by Rhone-Poulenc Ag Co.  66
             P-

                                        126
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                               BIBLIOGRAPHY
MRID
CITATION
42957302     Nygren, R. (1993) Ethephon--Validation of Ethylene Release Method of
             Analysis for Residues of Ethephon in Crop Materials: Lab Project Number:
             EC-92-228: 44155.  Unpublished study prepared by Rhone-Poulenc Ag Co.
             233 p.

43115301     Bernard, M. (1994) Product Chemistry: Manufacturing and Analytical Data for
             Ethephon. Unpublished study prepared by Cedar Chemical Corp. 31 p.

43143601     Miller, N. (1994) A Confined Rotational Crop Study with (carbon 14)
             Ethephon Using Radishes (Raphanus sativus), Collards (Brassica oleracea), and
             Wheat (Triticum aestivum): Lab Project Number: EC/91/158.  Unpublished
             study prepared by Rhone-Poulenc Ag Co., A&L Great Lakes Lab., Inc. 326 p.
                                       127
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APPENDIX D.  List of Available Related Documents
                     129
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       The following is a list of available documents related to Ethephon.  It's purpose is to
provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for Ethephon and are included in the EPA's Office of
Pesticide Programs Public Docket.

       1.     Health and Environmental Effects Science Chapters

       2.     Detailed Label Usage Information System (LUIS) Report

       3.     Ethephon RED Fact Sheet

       4.     PR Notice 86-5 (included in this appendix)

       5.     PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
             Statement
                                         131
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APPENDIX E.  PR Notices 86-5 and 91-2
                  133
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PR Notice 86-5
      135
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         \
         /        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                      WASHINGTON, D.C. 20460

                                            July 29, 1986

                                                                             OFFICE OF
                                      PR NOTICE 86-5              PREVENTION, PESTICIDES
                                                                     AND TOXIC SUBSTANCES

             NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
                                 AND REGISTRANTS

 Attention:     Persons responsible for Federal registration of pesticides.

 Subject:             Standard format for data submitted under the Federal Insecticide,
                    Fungicide, and Rodenticide Act (FIFRA) and certain provisions of the
                    Federal Food, Drug, and Cosmetic Act (FFDCA).

 I.  Purpose

       To require data to be submitted to the Environmental Protection Agency (EPA) in a
 standard format. This Notice also provides additional guidance about, and illustrations of, the
 required formats.

 II.  Applicability

       This PR Notice applies to all data that are submitted to EPA to satisfy data
 requirements for granting or maintaining pesticide registrations, experimental use permits,
 tolerances, and related approvals under certain provisions of FIFRA and FFDCA. These data
 are defined in FIFRA §10(d)(l). This Notice  does not apply to commercial, financial, or
 production information, which are, and  must  continue to be, submitted differently under
 separate cover.

 HI. Effective Date

       This notice is effective on November 1, 1986. Data formatted according to this notice
 may be submitted prior to the effective date. As of the effective date, submitted data packages
 that do not conform to these requirements may be returned to the submitter for necessary
 revision.

 IV.  Background

       On September 26, 1984, EPA published proposed regulations in the Federal Register
 (49 FR 37956) which include Requirements for Data Submission (40 CFR §158.32) and
 Procedures for Claims of Confidentiality of Data (40 CFR §158.33).  These regulations
 specify the format for data submitted to EPA under Section 3 of FIFRA and Sections 408 and
409 of FFDCA, and procedures which must be followed to make and substantiate claims of
confidentiality.  No entitlements to data confidentiality are changed, either by the proposed
regulation or by this notice.

      OPP is making these requirements mandatory through this Notice to gain resource-
saving benefits from their use before the  entire proposed regulation becomes final. Adequate
lead time is being provided for submitters to comply with the new requirements.
                                         137
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V.     Relationship of this Notice to Other OPP Policy and Guidance

       While this Notice contains requirements for organizing and formatting submittals of
supporting data, it does not address the substance of test reports themselves.  "Data reporting
guidance is now under development in OPP, and will specify how the study objectives,
protocol, observations, findings, and conclusions are organized and presented within the study
report. The data reporting guidance will be compatible with submittal format requirements
described in this Notice.

       OPP has also promulgated a policy (PR Notice 86-4 dated April 15, 1986) that
provides for early screening of certain applications for registration under FIFRA §3.  The
objective of the screen is to avoid the additional costs and prolonged delays associated with
handling significantly incomplete application packages.  As of the effective date of this Notice,
the screen will include in its criteria for acceptance  of application packages the data formatting
requirements described herein.

       OPP has also established a public docket which imposes deadlines for inserting into the
docket documents submitted in connection with Special Reviews and Registration Standards
(see 40 CFR §154.15 and §155.32).  To meet these deadlines, OPP is requiring an additional
copy of any data  submitted to the docket. Please refer to Page 10 for more information about
this requirement.

       For several years, OPP has required that each application for registration or other
action include a list of all applicable data requirements and an indication of how each is
satisfied-the statement of-the method of support for the application.  Typically, many
requirements are  satisfied by reference to data previously submitted-either by the applicant or
by another party. That reguirement is not altered by this notice, which applies only to data
submitted with an application.

VI.   Format Requirements

        A more detailed discussion of these format requirements follows the  index on the next
page, and samples of some of the requirements are attached. Except for the language of the
two alternative forms of the Statement of Data Confidentiality Claims (shown in Attachment 3)
which cannot be  altered, these samples are illustrative.  As long as the required information is
included and clearly identifiable, the form of the samples may be altered to  reflect the
submitter' s preference.

                                       - INDEX-
                                                                                    Text Example
                                                                                      Page  Page
A.     Organization of the Submittal Package	3    17

B.     Transmittal Document	4    11

 C.     Individual Studies	   4

        C. 1  Special Considerations for Identifying Studies  	   5

 D.     Organization of each Study Volume   	6    17

        D. 1 Study Title Page	7    12
        D. 2 Statement of Data Confidentiality Claims
             (based on FIFRA §10(d)(l))  	8    13
        D. 3 Confidential Attachment	8    15
        D. 4 Supplemental Statement of Data Confidentiality

                                                138
-------
            Claims (other than those based on FIFRA §10(d)(l))   	   8    14
        D. 5 Good Laboratory Practice Compliance Statement	9    16

 E.     Reference to Previously Submitted Data	   9

 F.     Physical Format Requirements & Number of Copies	   9

 G.     Special Requirements for Submitting Data to the Docket  	10
 A.    Organization of Submittal Package

       A "submittal package" consists of all studies submitted at the same time for review in
 support of a single regulatory action, along with a transmittal document and other related
 administrative material (e.g. the method of support statement, EPA Forms 8570-1, 8570-4,
 8570-20, etc.) as appropriate.

       Data submitters must organize each submittal package as described in this Notice.  The
 transmittal and any other administrative material must be grouped together in the first physical
 volume.  Each  study included in the submittal package must then be bound separately.

       Submitters sometimes provide additional materials that are intended to clarify,
 emphasize, or otherwise comment to help Product Managers and reviewers better understand
 the submittal.

       -  If such materials relate to one study, they should be included as an appendix to that
       study.

       - If such materials relate to more than one study (as for example a summary of all
       studies in a discipline) or to tne submittal in general, they must be included in the
       submittal package as a separate study (with title page and statement of confidentiality
       claims).

 B.     Transmittal Document

       The first item in each submittal package must be a transmittal document.  This
 document identifies the submitter or all joint submitters;  the regulatory action in support of
 which the package is being submitted-i.e.,  a registration application, petition, experimental
 use permit (EUP), §3(c)(2)(B) data call-in,  §6(a)(2) submittal, or a special review; the
 transmittal date; and a list of all individual studies included in the package in the order of their
 appearance, showing (usually by Guideline  reference number) the data requirement(s)
 addressed by each one. The EPA-assigned  number for the regulatory action (e.g. the
 registration, EUP, or tolerance petition number) should be included in the transmittal
 document as well, if it  is known to the submitter. See Attachment 1 for an example of an
 acceptable transmittal document.

       The list of included studies in the transmittal of a  data submittal package supporting a
 registration application should be subdivided by discipline, reflecting the order in which data
 requirements appear in 40 CFR  158.

       The list of included studies in the transmittal of a  data submittal package supporting a
petition for tolerance or an application for an EUP should be  subdivided into sections A  B
£,.... of the petition or application, as defined in 40 CFR 180.7 and 158.125, (petitions') or
Pesticide Assessment Guidelines, Subdivision I (EUPs) as appropriate.


                                          139
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       When a submittal package supports a tolerance petition and an application for a
registration or an EUP, list the petition studies first, then the balance of the studies.  Within
these two groups of studies follow the instructions above.

C.     Individual Studies

       A study is the report of a single scientific investigation, including all supporting
analyses required for logical completeness. A study should be identifiable and distinguishable
by a conventional bibliographic citation including author, date, and title. Studies generally
correspond in scope  to a single Guideline requirement for supporting data, with some
exceptions discussed in section C.I.  Each study included in a submittal package must be
bound as a separate entity.  (See comments on binding studies on page 9.)

       Each study must be consecutively paginated, beginning from the title page as page 1.
The total number of pages in the com-plete study must be shown on the study title page.  In
addition (to ensure that inadvertently separated pages can be reassociated with the proper study
during handling or review) use either or the following:

       - Include the total number of pages in  the complete study on each page (i.e.,  1 of 250,
       2 of 250, ...250 of 250).

       - Include a company name or mark and study number on each page of the study, e g ,
       Company Name-1986-23.  Never reuse a study number for marking the pages of
       subsequent studies.                                                .       .
       When a single study is extremely long, binding it in mul-tiple volumes is permissible
so long as the entire study is pag-inated in a single series, and each volume is plainly identified
by the study  title and its position in the multi-volume sequence.

C.I   Special Considerations for Identifying Studies

       Some studies raise special problems in study identification,  because they address
Guidelines of broader than normal scope or for other reasons.

       a. Safety Studies.  Several Guidelines require testing for safety in more than one
species. In these cases each species tested should be reported as a separate study, and bound
separately.

        Extensive supplemental reports of pathology reviews, feed  analyses, historical control
data and the like are often associated with safety studies.  Whenever possible these  should be
 submitted with primary reports of the study,  and bound with the primary study as appendices.
When such supplemental reports are submitted independently of the primary report, take care
to fully  identify the primary report to which they pertain.

        Batteries of acute toxicity tests, performed on the same end use product and covered by
 a single title page, may be bound together and reported as a single study.

        b. Product Chemistry Studies.  All product chemistry data within a submittal package
 submitted in support of an end-use product produced from registered manufacturing-use
 products should be bound as a single study under a single title page.

        Product chemistry data submitted in support of a technical  product,  other
 manufacturing-use product, an experimental  use permit, an import tolerance petition, or an
 end-use product produced from unregistered source ingredients, should be bound as a single
 study for each Guideline series (61, 62, and 63) for conventional pesticides, or for the
 equivalent subject range foFblbrational pesticides.  The first of the three studies in a complete
 product chemistry submittal for a biochemical pesticide would cover Guidelines 151-10,

                                            140
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 151-11, and 151-12; the second would cover Guidelines 151-13, 151-15, and 151-16; the third
 would cover Guideline 151-17. The first study for a microbial pesticide would cover
 Guidelines 151-20, 151-21, and 151-22; the second would cover Guidelines 151-23 and
 151-25; the third would cover Guideline 151-26.

        Note particularly that product chemistry studies are likely to contain Confidential
 Business Information as defined in FIFRA §10(d)(l)(A), (B), or (C), and if so must be
 handled as described in section D.3. of this notice.

        c. Residue Chemistry Studies.  Guidelines 171-4, 153-3, and 153-4 are extremely
 broad in scope; studies addressing residue chemistry requirements must thus be defined at a
 level below that of the Guideline code. The general principle, however, of limiting a study to
 the report of a single investigation still applies fully.  Data should be treated as a single study
 and bound separately  for each analytical method, each report of the nature of the residue in a
 single crop or animal species,  and for each report of the magnitude of residues resulting from
 treatment of a single crop  or from processing a single crop.  When more than one commodity
 is derived from a single crop (such as beet tops and beet roots) residue data on all such
 commodities should be reported as a single study. When multiple field trials are associated
 with a single crop, all such trials should be reported as a single study.

 D.     Organization of Each Study Volume

        Each complete study must include all applicable elements in the list below, in the order
 indicated.  (Also see Page 17.) Several of these elements are further explained in the following
 paragraphs.  Entries in the column headed "example" cite the page number of this notice
 where the element is illustrated.
Element

Study Title Page

Statement of Data
Confidentiality
Claims

Certification of Good
Laboratory Practice
Flagging statements
Body of Study


Study Appendices

Cover Sheet to Confi-
dential Attachment

CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
       When Required

Always

One of the two alternative
forms of this statement
is always required

If study reports laboratory
work subject to GLP require-
ments

For certain toxicology studies (When
flagging requirements are finalized.)

Always - with an English language
translation if required.

At submitter's option

If CBI is claimed under FIFRA
§10(d)(l)(A), (B), or (C)

If CBI is claimed under FIFRA
§10(d)(l)(A), (B),or(C)

Only if confidentiality is
claimed on a basis other than
FIFRA §10(d)(l)(A), (B), or (C)
       Example
Page 12

Page 13



Page 16
Page 15

Page 14
                                          141
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D.I.   Title Page

       A title page is always required for each submitted study, published or unpublished.
The title page must always be freely releasable to requestors; DO NOT INCLUDE CBI ON
THE TITLE PAGE.  An example of an acceptable title page is on page 12 of this notice.
The following information must appear on the title page:

a.     Study title. The study title should be as descriptive as possible It must clearly identify
the substance(s) tested and correspond to the name of the data requirement as it appears in the
Guidelines.

b.     Data requirement addressed. Include on the title page the Guideline number(s) of the
specific requirement(s) addressed by the  study.

c.     Author(s).  Cite only individuals with primary intellectual responsibility for the content
of the study. Identify them plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on the title page.

d.     Study Date.  The title page must include a single date for the study. If parts of the
study were performed at different times, use only the date of the latest element in the study.

e.     Performing Laboratory Identification.  If the study reports work done by  one or more
laboratories, include on the title page the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for the work. Clearly distinguish
the laboratory's project identifier from any other reference numbers provided by the study
sponsor or submitter.

f.     Supplemental Submissions.  If the study is a commentary on or supplement to another
previously submitted study, or it it responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the previously  submitted study,
along with the EPA Master Record Identifier (MRID) or Accession number of the earlier
study if you know these numbers.  (Supplements  submitted in the same submittal package as
the primary study should be appended to and bound with the primary study. Do not include
supplements to more than one study under a single title page).

g.      Facts of Publication. If the study is a reprint of a published document, identity on the
title page all relevant tacts of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.


D.2.   Statements of Data Confidentiality Claims Under FIFRA  §10(d)(l).

        Each submitted study must be accompanied by one of the two alternative  forms of the
statement of Data Confidentiality Claims specified in the proposed regulation in §158.33 (b)
and  (c) (See Attachment 3).  These statements apply only to claims of data confidentiality
based on FIFRA §10(d)(l)(A), (B), or (C). Use the appropriate alternative form of the
statement either to assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or to waive
such a claim (§158.33(c)).  In either case, the statement must be  signed and dated, and must
include the typed name and title of the official who signs it.  Do not make CBI claims with
respect to analytical methods associated with pet-itions for tolerances or emergency
exemptions (see NOTE Pg 13).

                                          142
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 D. 3.   Confidential Attachment

       If the claim is made that a study includes confidential business information as defined
 by the criteria of FIFRA §10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
 information must be excised from the body of the study and confined to a separate
 study-specific Confidential Attachment. Each passage of CBI so isolated must be identified by
 a reference number cited within the body of the study at the point from which the passage was
 excised (See Attachment 5).

       The Confidential Attachment to a study must be identified by a cover sheet fully
 identifying the parent study, and must be clearly marked "Confidential Attachment."  An
 appropriately annotated photocopy of the parent study title page may be used as this cover
 sheet. Paginate the Confidential Attachment separately from the body of the study, beginning
 with page 1  of X on the  title page.  Each passage confined to the Confidential Attachment
 must  qe associated with  a specific cross reference to the page(s) in the main body of the study
 on which it is cited, and with a reference to the applicable passage(s) of FIFRA §10(d)(l) on
 which the confidentiality claim is based.

 D.4.   Supplemental Statement of Data Confidentiality Claims (See
       Attachment 4)

       If you wish to make a claim of confidentiality for any portion of a submitted study
 other than described by FIFRA §10(d) (1)(A), (B), or (C), the following provisions apply:

       - The specific information to which the claim applies must be clearly marked in the
       body of the study as subject to a claim of confidentiality.

       - A Supplemental Statement of Data Confidentiality Claims must be submitted,
       identifying eachpassage claimed confidential and describing  in detail the basis for the
       claim.   A list of the points to address in such a statement is included in Attachment 4
       on Pg 14.

       - The Supplemental Statement of Data Confidentiality'Claims must be signed and dated
       and must include the typed name and title of the official  who signed it.

 D.5.   Good Laboratory Practice Compliance Statement

       This  statement is  reauired if the study contains laboratory work subject to GLP
 requirements specified in 40 CFR 160. Samples of these statements are shown in Attachment
 6.

 E.     Reference to Previously Submitted Data

       DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
 FOR  ANOTHER PURPOSE unless EPA specifically  requests  it.   A copy of the title page
 plus the MRID number (if known) is sufficient to allow us to retrieve the study immediately
 for review.  This prevents duplicate entries in the Agency  files,  and  saves you
 the cost of sending more copies of the study. References to previously submitted studies
 should not be included in the transmittal document, but should be incorporated into the
 statement of the method of support for the application.

F.     Physical Format Requirements

       All elements in  the data submittal package must be on uniform 8 1/2 by 11 inch white
paper, printed on one side only in black ink, with high contrast and good resolution.  Bindings
for individual studies must be secure, but  easily removable to permit disassembly  for

                                         143
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microfilming.  Check with EPA for special instructions before submitting data in any medium
other than paper, such as film or magnetic media.

Please be particularly attentive to the following points:

       •      Do not include frayed or torn pages.

       •      Do not include carbon copies, or copies in other than black ink.

       •      Make sure that photocopies are clear, complete, and fully readable.

       •      Do not include oversize computer printouts or fold-out pages.

       •      Do not bind any documents with glue or binding tapes.

       •      Make sure that all pages of each study, including any attachments or
              appendices, are present and in correct sequence.

       Number of Copies Required - All submittal packages except those associated with a
 Registration Standard or Special Review (See Part G below) must be provided In three
 complete, identical copies.  (The proposed regulations specified two copies; three are now
 being required to expedite and reduce the cost of processing data into the OPP Pesticide
 Document Management System and getting it into review.)

 G.    Special Requirements for Submitting Data to the Docket

       Data submittal packages associated with a Registration Standard or Special Review
 must be provided in four copies, from one of which all material claimed as CBI has been
 excised   This fourtlfcopy will become part of the public docket for the RS or SR case.  If no
 claims of confidentiality are made for the study, the fourth copy should be  identical to the
 other three.  When portions of a study submitted in support of an RS or SR are claimed as
 CBI the first three copies will include the CBI material as provided in section D ot this
 notice. The following special preparation is required for the fourth copy.

        •     Remove the "Supplemental Statement of Data Confidentiality Claims".

        •     Remove the "Confidential Attachment".

        •      Excise from the body of the study any information you claim as confidential,
              even if it does not fall within the scope of FIFRA §10(d)(l)(A), (B), or (C).
               Do not close up or paraphrase text remaining after this excision.

        •      Mark the fourth copy plainly on both its cover and its title page with the phrase
               "Public Docket Material - contains no information claimed as confidential".
                                           144
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V.     For Further Information

      For further information contact John Carley, Chief, Information Services Branch,
Program Management and Support Division, (703) 305-5240.
                                      /S/

                                James W. Akerman
                                Acting Director,
                                Registration Division
Attachment 1.       Sample Transmittal Document
Attachment 2.       Sample Title Page for a Newly Submitted Study
Attachment 3.       Statements of Data Confidentiality Claims
Attachment 4.       Supplemental Statement of Data Confidentiality    Claims
Attachment 5.       Samples of Confidential Attachments
Attachment 6.       Sample Good Laboratory Practice Statements
Attachment 7.       Format Diagrams for Submittal Packages and Studies
                                        145
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                                ATTACHMENT 1
       ELEMENTS TO BE INCLUDED IN THE TRANSMIT!AL DOCUMENT*
1.     Name and address of submitter (or all joint submitters**)
+Smith Chemical Corporation                  Jones Chemical Company
 1234 West Smith Street           -and-        5678 Wilson Blvd
 Cincinnati, OH 98765                        Covington, KY 56789

+Smith Chemical Corp will act as sole agent for all submitters.
2.     Regulatory action in support of which this package is submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know it. Otherwise describe the
type of request (e.g. experimental use permit,  data call-in - of xx-xx-xx date).
3.     Transmittal date
4.     List of submitted studies
      Vol 1. Administrative materials - forms, previous corres-pondence with Project
             Managers, and so forth.
      Vol 2. Title of first study in the submittal (Guideline No.)
      Vol n  Title of nth study in the submittal (Guideline
                   No.)
      *      Applicants commonly provide this information in a tran-smittal letter.  This
             remains an acceptable practice so long as all four elements are included.
      *      Indicate which of the joint submitters is empowered to act on behalf of all joint
             submitters in any matter concerning data compensation or subsequent use or
             release of the data.
Company Official:
                          Signature                              Name
Company Name	
Company Contact:
                   Name                                        Phone
                                        146
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                      ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
                          Study Title
          (Chemical name) - Magnitude of Residue on Corn
                       Data Requirement
                       Guideline 171-4
                           Author
                        John C. Davis
                      Study Completed On
                       January 5, 1979
                     Performing Laboratory
                 ABC Agricultural Laboratories
                      940 West Bay Drive
                     Wilmington, CA 39897
                     Laboratory Project ID
                         ABC 47-79
                            147
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              Pagel ofX
(X is the total number of pages in the study)
                  148
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                                 ATTACHMENT 3

               STATEMENTS OF DATA CONFIDENTIALITY CLAIMS

 1. No claim of confidentiality under FIFRA §10(d)(l)(A),(B), or (Q.

           STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
    No claim of confidentiality is made  for  any information contained in this
    study on the basis of its falling within the scope of FIFRA
    6§10(d)(1)(A),  (B),  or  (C).
    Company
    Company Agent: 	Typed Name	 Date:.


    	Title	  	Signature
2. Claim of confidentiality under FIFRA §10(d)(l)(A), (B), or (Q.
    Information claimed confidential on the basis  of  its  falling within the
    scope of FIFRA §10(d)(1)(A),   (B), or  (C) has been removed to a
    confidential appendix,  and is cited by cross-reference  number in the body
    of  the study.
     Company:
     Company Agent:        Typed Name	 Date:.


    		Title	  Signature 	
               STATEMENT OF DATA CONFIDENTIALITY CLAIMS

NOTE: Applicants for permanent or temporary tolerances should note that it is OPP policy
that no permanent tolerance, temporary tolerance, or request for an emergency exemption
incorporating an analytical method,  can be approved unless the applicant waives all claims of
confidentiality for the analytical method.  These analytical methods are published in the FDA
Pesticide Analytical Methods Manual, and therefore cannot be claimed as confidential. OPP
implements this policy by returning  submitted analytical methods, for which confidentiality
claims have been made, to the submitter, to obtain the confidentiality waiver before they can
be processed.
                                      149
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                                  ATTACHMENT 4

       SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
       For any portion of a submitted study that is not described by FIFRA §10(d)(l)(A), (B),
or (C), but for which you claim confidential treatment on another basis, the following
information must be included within a Supplemental Statement of Data Confidentiality Claims:

       •     Identify specifically by page and line number(s) each portion of the study for
             which you claim confidentiality.

       •     Cite the reasons why the cited passage qualifies for confidential treatment.

       •     Indicate the length of time-until a specific date or event, or permanently--for
             which the information should be treated as confidential.

       •     Identify the measures taken to guard against undesired disclosure of this
             information.

       •     Describe the extent to which the information has been disclosed, and what
             precautions have been taken in connection with those disclosures.

       •     Enclose copies of any pertinent determinations of confidentiality made by EPA,
             other Federal agencies, of courts concerning this information.

       •     If you assert that disclosure of this information would be likely to result in
             substantial harmful effects to you, describe those harmful effects and explain
             why they should be viewed as substantial.

       •     If you assert that the information in voluntarily submitted, indicate whether you
             believe disclosure of this information might tend to lessen the availability to
             EPA of similar information in the future, and if so, how.
                                          150
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                                    ATTACHMENT 5

              EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS

 Example 1. (Confidential word or phrase that has been deleted from the study)
    CROSS REFERENCE NUMBER 1       This cross reference number is used in the study in place of the
                                      following paragraph(s) at the indicated volume and page
                                      references.
    DELETED WORDS OR PHRASE:             Ethylene Glycol
    PAGE         LINES REASON FOR THE DELETION                     FIFRA
    REFERENCE                  "                                      	
     6            14     Identity of Inert Ingredient                           S10(d)(C)
    28            25            "                                          „
    100           19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
  CROSS REFERENCE NUMBER 5       This cross reference number is used in the study in place of the
                                   following paragraph(s) at the indicated volume and page
                                   references.
  DELETED PARAGRAPH(S):

        <                                                                  )
        (      Reproduce the deleted paragraph(s) here                              \

        <                                                                  )

  PAGE         LINES REASON FOR THE DELETION               FIFRA REFERENCE
  20•           2-17   Description of the quality control process          §10(d)(l)(C)
Example 3. (Confidential pages that have been deleted from the study)
 CROSS REFERENCE NUMBER 7      This cross reference number is used in the study in place of the
                                  following paragraph(s) at the indicated volume and page
                                  references.
 DELETED PAGES(S):  are attached immediately behind this page

 PAGES        REASON FOR THE DELETION               FIFRA REFERENCE
 35-41.         Description of product manufacturing process             § 10(d)( 1 )(A)
                                         151
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                             ATTACHMENT 6.

            SAMPLE GOOD LABORATORY PRACTICE STATEMENTS

Example 1.
     This study meets the requirements for 40 CFR Part 160

           Submitter	

           Sponsor	—.—
Example 2.
    This study does not meet the requirements of 40 CFR Part 160,  and
    differs in the following ways:
    1..

    2..

    3.
          Submitter.

          Sponsor	
          Study Director.
Example 3.
    The submitter of  this study was neither  the sponsor of this study  nor
    conducted it,  and does not know whether  it has been conducted in
    accordance with 40 CFR Part 160.

          Submitter	
                                    152
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               ATTACHMENT 7.


     FORMAT OF THE SUBMITTAL PACKAGE
        Transmfttal Document

            Related Administrative Materials
            (e.g. Method of Support Statement, etc.)

                   Other materials about the submittal
                   (e.g., summaries of groups of studies
                   to aid in their review).

                           Studies submitted as unique
                           to the format below.
      FORMAT OF SUBMITTED STUDIES
Study title page.

     Statement of Confidentiality Claims.

           GLP and flagging* statements - as appropriate.

                 Body of the study, with English
                 language translation if required.
                    . Appendices to the study.

                         Title Page of the Confidential
                 :—	Attachment.
                         — Confidential Attachment.

                         .	Supplemental Statement
                              of Confidentiality Claims

            :	"  *  When flagging requirements
                     are finalised.

Documents which must be submitted as
appropriate to meet established requirements.

     Documents submitted at submitter's option.
LEGEND
                     153
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PR Notice  97-2
      155
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                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                       WASHINGTON, D.C. 20460
                                                                           OFFICE OF
                                                                      PREVENTION. PESTICIDES
                                                                      AND TOXIC SUBSTANCES
                                   PR NOTICE 91-2

           NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
                         AND REGISTRANTS OF PESTICIDES

 ATTENTION: Persons Responsible for Federal Registration of Pesticide Products.

 SUBJECT: Accuracy of Stated Percentages for Ingredients
 Statement

 I. PURPOSE:

       The purpose of this notice is to clarify the Office of Pesticide Program's policy with
 respect to the statement of percentages in a pesticide's label's ingredient statement.
 Specifically, the amount (percent by weight) of ingredient(s) specified in the ingredient
 statement on the label must be stated as the nominal concentration of such ingredient(s) as that
 term is defined in 40 CFR 158.153(i). Accordingly, the Agency has established the nominal
 concentration as the only acceptable label claim for the amount of active ingredient in the
 product.

 H. BACKGROUND

       For some time the Agency has accepted two different methods of identifying on the
 label what percentage is claimed for the ingredient(s) contained in a pesticide. Some applicants
 claimed a percentage which represented a level between the upper and the lower certified
 limits. This was referred to as the n9minal concentration. Other applicants claimed the lower
 limit as the percentage of the ingredient(s) that would be expected! to be present in their
 product at the end of the product's shelf-life. Unfortunately, this led to a great deal of
 confusion among the regulated industry, the regulators, and the consumers as to exactly how
 much of a given ingredient was in a given product. The Agency has established the nominal
 concentration as the only acceptable label claim for the amount of active ingredient in the
 product.

       Current regulations require that the percentage listed in the active ingredient statement
 be as precise as possible reflecting good manufacturing practices 40 CFR 156.10(g)(5). The
 certified limits required for each active ingredient are intended to encompass any such "good
 manufacturing practice" variations 40 CFR 158.175(c)(3).

       The upper and lower certified limits, which must be proposed in connection with a
 Product's registration, represent the amounts of an ingredient that may legally be present 40
 CFR 158.175.  The lower certified limit is used as the enforceable lower limit for the product
 composition according to FIFRA section 12(a)(l)(C), while the nominal concentration
 appearing on the label would be the routinely achieved concentration used for calculation of
 dosages and dilutions.

       The nominal concentration would in fact state the greatest degree of accuracy that is
 warranted with respect to actual product composition because the nominal concentration would
 be the amount of active ingredient typically found in the product.

       It is important for registrants 19 note that certified limits for active ingredients are not
considered to be trade secret information under FIFRA section 10(b). In this respect the


                                         157
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certified limits will be routinely provided by EPA to States for enforcement purposes, since
the nominal concentration appearing on the label may not represent the enforceable
composition for purposes or section 12(a)(l)(C).

IE. REQUIREMENTS

       As described below under Unit V.  " COMPLIANCE SCHEDULE," all currently
registered products as well as all applications for new registration must comply with this
Notice by specifying the nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s)  statement and equivalence statements if applicable (e.g.,
elemental arsenic, metallic zinc, salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be fulfilled. Copies of the raw
analytical data must be submitted with the nominal ingredient label claim. Further information
about the analysis requirement  may be found in the 40 CFR 158.170.  All products are
required to provide certified limits for each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) only) and on a case by case basis as specified by EPA. These
limits are to be set based on representative sampling and chemical analysis(i.e., quality
control) of the product.

       The format of the ingredient statement must conform to 40 CFR 156-Labeling
Requirements For Pesticides and Devices.

       After July 1, 1997, all pesticide ingredient Statements must be changed to
nominal concentration.

IV. PRODUCTS THAT REQUIRE EFFICACY DATA

       All pesticides are required to be efficacious. Therefore, the certified lower limits may
not be lower then the minimum level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the public health, e.g., certain
antimicrobial and rodenticide products. Refer to 40 CFR 153.640.

       In those cases where efficacy limits have been established,  the Agency will not accept
certified lower limits which are below that level for the shelf life of the product.

V. COMPLIANCE SCHEDULE

       As described earlier, the purpose of this Notice is to make  the registration process
more uniform and more manageable for both the agency and the regulated community. It is
the Agency's intention to implement the requirements of this notice as smoothly as possible so
as not to disrupt or delay the Agency's high priority programs, i.e., reregistration, new
chemical, or fast track (FIFRA section 3(c)(3)(B). Therefore, applicants/registrants are
expected to comply with the requirements of this Notice as follows:

       (1)    Beginning July 1, 1991, all new product registrations submitted to the Agency
              are to comply with the requirements of this Notice.

       (2)    Registrants having products subject to reregistration under FIFRA section 4(a)
              are to comply with the requirements of this Notice when specific products are
              called in by the Agency under Phase V of the Reregistration Program.
                                          158
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       (3)    All other products/applications that are not subject to (1) and (2) above will
             have until July 1, 1997, to comply with this Notice. Such applications should
             note  Conversion to Nominal Concentrations on the application form. These
             types Or amendments will not be handled as "Fast Track" applications but will
             be handled as routine requests.

VI. FOR FURTHER INFORMATION

Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.


                                             /s/
                                 Anne E. Lindsay, Director
                                 Registration Division (H-7505C)
                                        159
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APPENDIX F. Combined Generic and Product Specific
                  Data Call-In
                      161
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                  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                      WASHINGTON, D.C.  20460
                         GENERIC AND PRODUCT SPECIFIC
                               DATA CALL-IN NOTICE                   28 A''R  J°95

 CERTIFIED MAIL
 Dear Sir or Madam:
       This Notice requires you and other registrants of pesticide products containing the
 active ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status
 jffg**' to submit certam data as noted herein to the U.S. Environmental Protection Agency
 (UFA, the Agency). These data are necessary to maintain the continued registration of your
 product(s) containing this active ingredient. Within 90 days after you receive this Notice you
 must respond as set forth in Section III below. Your response must state:

       1.      How you will comply with the requirements set forth in this Notice and its
              Attachments 1 through 7; or

       2.      Why you believe you are exempt from the requirements listed in this Notice and
              in Attachment 3 (for both generic and product specific data), the Requirements
              Status and Registrant's Response Form, (see section ffl-B); or  —	

       3.      Why you believe EPA should not require your submission of data in the manner
              specified by this Notice (see section ffl-D).

       If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
 with its requirements or should be exempt or excused from doing so,  then the registration of
 your product(s) subject to this Notice will be subject to suspension.  We have provided a list of
 all of your products subject to this Notice in Attachment 2.  All products are listed on both the
 generic and product specific Data Call-in Response Forms.   Also included is a list of all
 registrants who were sent this Notice (Attachment 6)	
  A D Jhta^tholity for this ?yice is section 3(C)(2>(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
fmn^^^m0^-^^^ Paperwork Reduction Act by OMB Approval No.
2070-0107 and 2070-0057 (expiration date 3-31-96).

      This Notice is divided into six sections and seven Attachments. The Notice itself
contains information and instructions applicable to all Data Call-In Notices. The Attachments
contain specific chemical information and instructions. The six sections of the Notice are-
                                         163
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Section I     -      Why You are Receiving this Notice
Section n     -      Data Required by this Notice
Section HI    -      Compliance with Requirements of this Notice
Section IV    -      Consequences of Failure to Comply with this Notice
Section V     -      Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Section VI    -      Inquiries and Responses to this Notice

      The Attachments to this Notice are:

      1 -    Data Call-In Chemical Status Sheet
      2 -    Generic Data (Jall-ln and Product Specific Data Call-In Response Forms with
             Instructions
      3 -    Generic Data Call-In and Product Specific Data Call-In Requirements Status
             and Registrant s Response Forms with Instructions
      4-    bFA (Jroupmg ot End-Use Products for Meeting Acute Toxicology Data
             Kequirements tor  Keregistration
      5 -    fcFA Acceptance Criteria
      6 -    List ol Registrants Receiving This Notice
      7 -    Cost Share and Data Compensation horrris


SECTION I. WHY YOU ARE RECEIVING THIS NOTICE

      The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because
you have product(s) containing the subject active ingredients.


SECTION II. DATA REQUIRED BY THIS NOTICE

II-A.  DATA REQUIRED

      The data required  by this Notice are specified in the Requirements Status and
Registrant's Response Forms: Attachment 3 (for both generic and product specific data
requirements).  Depending  on the results of the studies required in this Notice, additional
studies/testing may be required.

II-B.  SCHEDULE FOR SUBMISSION OF DATA

      You are required to submit the data or otherwise satisfy the data requirements specified
in the Requirements Status and Registrant's Response Forms (Attachment 3) within the
timeframes provided.

II-C.  TESTING PROTOCOL

      All  studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.

      These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:
703-487-4650).
                                         164
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 ,^T^T         aPProved by the Organization for Economic Cooperation and Development
 (OECD) are also acceptable if the OECD recommended test standards conform to those
 specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
 OECD protocols, they should be modified as appropriate so that the data generated by the
 study will satisfy the requirements of 40 CFR §  158. Normally, the Agency will not extend
 deadlines for complying with data requirements when the studies were not conducted in
 accordance with acceptable standards. The OECD protocols are available from OECD  2001 L
 Streut'  ^vSf'AoYSSKSS1011' D'C 20036 (TelePh<>ne number 202-785-6323; Fax telephone
 number 202-785-0350).

        All new studies and proposed protocols submitted in response to this Data Call-In
 Notice  must be in accordance  with Good Laboratory Practices [40 CFR Part 160].

 n-D.   REGISTRANTS  RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED
        UY Itib AUhJNCJY                       ~	

        Unless otherwise noted herein, this Data Call-in does not in any way supersede or
 change the requirements of any previous yata uaiMn(s). or any other agreements entered into
 with tne Agency pertaining to  such prior Notice. Registrants must comply with the
 requirements of all Notices to  avoid issuance of a Notice of Intent to Suspend their affected
 products.


 SECTION III.      COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
    •    SH must use the correct forms and instructions when completing your response to this
 Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is
 specified in item number 3 on the four Data Call-in forms (Attachments 2 and 3).

 III-A. SCHEDULE FOR RESPONDING TO THE AGENCY

       The appropriate responses initially required by this Notice for generic and product
 specific data must be submitted to the Agency within 90 days after your receipt of this Notice
 Failure to adequately respond to this Notice within 90 days of your receipt will be a basis for
 issuing a Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for
 issuance of NOIS due to failure to comply with this Notice are presented in Section IV-A and
 1V-B.

 ni-B. OPTIONS FOR RESPONDING TO THE AGENCY

       1. Generic Data Requirements

       The options for responding to this Notice for generic data requirements are- (a)
 voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy
 the generic data requirements imposed by this Notice or (e) request a data  waiver(s).

       A discussion of how to respond if you choose the Voluntary Cancellation option, the
 Delete Use(s) option or the Generic Data Exemption option is presented below.  A discussion
 ot the various options available for satisfying  the generic data requirements of this Notice is
 contained in Section ffl-C. A discussion of options relating to requests for  data waivers is
 contained in Section ffl-D.

       Two forms apply to generic data requirements, one or both of which must be used in
 responding to the Agency, depending upon your response. These two forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form
(contained in Attachments 2 and 3, respectively).	^	 	'
                                        165
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       The Data Call-In Response Forms must be submitted as part of every response to this
Notice. The Requirements Status and Registrant's Response Forms also must be submitted if
you do not quality tor a Uenenc Data Exemption or are not requesting voluntary cancellation
of your registration(s). Please note that the company's authorized representative is required to
sign the first page of both Data Call-in Response Forms and the Requirements Status and
Registrant's Response Forms (it this torm is required) and initial any subsequent pages. The
forms contain separate detailed instructions on the response options. Do not alter the printed
material. If you have questions or need assistance in preparing your response, call or write the
contact person(s) identified in Attachment 1.

       a.     Voluntary Cancellation -

       You  may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit completed Generic and Product Specific
Data Call-In Response Forms (Attachment 2), indicating your election of this option.
Voluntary cancellation is item number 5 on both Data Call-in Response Fprm(s). If you
choose this option, these are the only forms that you are required to complete.

       If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.

       b.     Use Deletion -

       You  may avoid the requirements of this Notice by eliminating  the uses of your product
to which the requirements apply. If you wish to amend your registration to delete uses, you
must submit the Requirements Status and  Registrant's Response Form (Attachment 3), a
completed application tor amendment, a copy of your proposed amended labeling, and all
other information required for processing the application. Use deletion is option number 7
under item 9 in the instructions for the Requirements Status and Registrant's Response Forms.
You must also complete a Data Call-In Response horm by signing the certification,  item
number 8.  Application forms tor amending^ registrations may be obtained from the
Registration Support Branch, Registration Division, Office of Pesticide Programs, EPA, by
calling (703) 308-8358.

       If you choose to delete  the use(s) subject to this Notice or uses subject to specific data
requirements, further  sale, distribution, or use  of your product after one year from the due
date of your 90 day response, is allowed only if the product bears an amended label.

       c.     Generic Data Exemption -

       Under section  3(c)(2)(D) of FIFRA, an applicant for registration of a product is
exempt from the requirement to submit or cite generic data concerning an active ingredient if
the active ingredient in the product is derived exclusively from purchased, registered pesticide
products containing the active ingredient.  EPA has concluded, as  an exercise of its discretion,
that it normally will not suspend the registration of a product which would qualify and
continue to qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify,
all of the following requirements must be met:

       (i).  The active ingredient in your  registered product must be present solely because of
       incorporation of another registered product which contains the subject active ingredient
       and is purchased from a source not connected with you;
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       (ii).  Every registrant who is the ultimate source of the active ingredient in your
       product subject to this DCI must be in compliance with the requirements of this Notice
       and must remain in compliance; and

       (iii). You must have provided to  EPA an accurate and current "Confidential Statement
       or formula  tor each of your products to which this Notice applies.

       To apply  for the Generic Data Exemption you must submit a completed Data Call-In
Response Form  Attachment 2 and all supporting documentation. The Generic Data Exemption
is item number 6a on the Data Call-in Response Form. If you claim a generic dato
 ou are not re                                                     '
                                                   .
 you are not required to complete the Requirements Status and Registrant's Response Forn
 (jenenc Data Exemption cannot be selected as an option tor responding to product specific


        ?! y?uu a[e 8rante(! a Generic Data Exemption, you rely on the efforts of other persons
 to provide the Agency with the required data. If the registrant(s) who have committed to
 generate and submit the required data fail to take appropriate steps to meet requirements or are
 no longer in compliance with this Data Call-in Notice, the Agency will consider that both thev
 and you are not compliance and will normally initiate proceedings to suspend the registrations
 of both your and their product(s), unless you commit to submit and do submit the required
 data within the specified time. In such cases the Agency generally will not grant a time
 extension for submitting the data.                                      6

       d-     Satisfying the Generic Data Requirements of this Notice

 XT *•   TJlere are Yarious options available to satisfy the generic data requirements of this
 Notice These options are discussed in Section m-C.l. of this Notice and comprise options 1
 forough 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
 Form and item 6b on the Data Call-in Response form.  It you  choose .te^ frh ^r.*fn™"?c%
 tfie-generic data requirements), you must submit the Data Call-in Response Form and the
 Requirements Status and Registrant's Response Form as well as any  other information/data
                                                                               be on the
              Request for Generic Data Waivers.

       Waivers for generic data are discussed in Section IH-D.l. of this Notice and are
     fra«7o°£!!0nS   r  9 °fTitem 9 JP ** instructions for the Requirements Status and
      rants Response Form. If you choose one of these options, you must submit both forms
as wen as any other information/data pertaining  to the option chosen to address the data
requirement.
       2. Product Specific Data Requirements

       T-he °ftl°ns for/esP9nding to this Notice for product specific data are: (a) voluntary
                                                     re^rements imP°sed by this NoTice
       A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below.  A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section IH-C.2. A discussion of
options relating to requests for data waivers is contained in Section IH-D 2
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       Two forms apply to the product specific data requirements one or both of which must
be used in responding to the Agency, depending upon your response.  These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form,
tor product specinc data (contained in Attachments 2 and 3, respectively).  The Date (Jall-Tn
Response Form must be submitted as part of every response to this Notice. In addition, one
copy ot the Requirements Status and Registrant's Response Form also must be submitted for
each product listed on the Data Uall-ln Response Form unless the voluntary cancellation option
is selected.  Please note that the company's authorized representative is required to sign the
first page of the Data Call-in Response Form and Requirements Status and Registrant s
Response Form (it this torm is required) ana initial any subsequent pages.  The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or write the contact
person(s) identified in Attachment 1.

       a.    Voluntary Cancellation

       You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active  ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit a completed Data Call-In Response Form,
indicating your election of this option. Voluntary cancellation is item number S on both the
Generic and Product Specific Data Call-In Response Forms. If you choose this
option, you must complete both Data Call-In response torms. These are the only forms that
you are required to complete.

       If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with  the Existing Stocks
provisions of this Notice which are contained in Section IV-C.

       b.    Satisfying the Product  Specific Data Requirements of this Notice.

       There are various options available to satisfy the product specific data requirements of
this Notice. These options are discussed in Section ffl-C.2. of this Notice and comprise
options 1 through 6 of item 9 in the instructions for the product specific Requirements Status
and Registrant's Response Form and  item numbers 7a and 7b (agree to satisfy the product
specific data requirements tor an MUP or EUP as applicable) on the product specinc Data
Call-in Response Form. Note that the options available  for addressing product specific data
requirements ditter slightly from those options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options  for fulfilling
product specific data requirements. It is important to ensure that you are using the correct
forms and instructions when completing your response to the Reregistration Eligibility
Decision document.

       c.    Request for Product Specific Data Waivers.

       Waivers for product specific data are discussed in Section ffl-D.2.  of this Notice and
are covered by option 7 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you  choose this  option, you must submit the Data (Jail-In
Response Form and the Requirements Status and Registrant's Response Form as well as any
other mtormation/data pertaining  to the option chosen to address the data requirement.  Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
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 m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

        1.      Generic Data

        If you acknowledge on the Generic Data Call-In Response Form that you agree to
 satisfy the generic data requirements (i.e. you select item number 6b), then you must select
 one of the six options on the Generic Requirements Status and Registrant's Response Form
 related to data production for each daia requirement.  Vour option selection should be entered
 under item number 9,  Registrant Response." The six options related to data production are
 the first six options discussed under item 9 in the instructions for completing the Requirements
 Status and Registrant's Response Form. These six options are listed       6      M
 immediately below with information in parentheses to guide you to additional instructions
 provided in this Section. The options are:

        0)    J. will generate and submit data within the specified timeframe (Developing

        (2)    I have entered into an agreement with one or more registrants to develop data
              jointly (Cost Sharing)                                             ^
        (3)    I have made offers to cost-share (Offers to Cost Share)
        (4)    I am submitting an existing study that has not been submitted previously to the
              Agency by anyone (Submitting an Existing Study)
        (5)    I am submitting or citing data to upgrade a study classified by EPA as partially
              acceptable and upgradeable (Upgrading a Study)
        (6)    I am citing an existing study that EPA has classified as acceptable or an existing
              study that has been submitted but not reviewed by the  Agency (Citing an
              Existing Study)                                                6

 Option  1 . Developing Data
 A   Ar If you, drop86*0 develop the required data it must be in conformance with Agency
 deadlines and with other Agency requirements as referenced herein and in the attachments  All
 ?^D^n5?^aud s^™^ must comply with the Good Laboratory Practice (GLP) rule (40
 C^K Fart 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and  be
 in conformance with the requirements of PR Notice 86-5. In addition, certain studies require
 Agency approval of test protocols in advance of study initiation. Those studies for which a
 grotocol must be submitted have been identified in the Requirements Status and Registrant's
 Response Form and/or footnotes to the form. If you wish to use a protocol which differs trom
 me options discussed in Section E-C of this Notice, you must submit a detailed description  of
 the proposed protocol and your reason for wishing to use it. The Agency may choose to reject
 a protocol not specified in Section H-C. If the Agency rejects your protocol you will be   J
 notified in writing, however  you should be aware that rejection of a proposed protocol will
 not be a basis for extending the deadline for submission  of data.

       A progress report must  be submitted for each study within  90 days from the date vou
are required to commit to generate or undertake some other means to address that studv
requirement such as making an offer to cost share or agreeing to share in the cost of
developing that study.  This 90-day progress report must include the date the study was or will
be initiated and   for studies to be started within 12 months of commitment, the name and
address of the laboratory(ies) or individuals who are or will be conducting the study
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       In addition, if the time frame for submission of a final report is more than 1 year,
interim reports must be submitted at 12 month intervals from the date you are required to
commit to generate or otherwise address the requirement for the study. In addition to the other
information specified in the preceding paragraph, at a minimum, a brief description of current
activity on  and the status of the study must be included as well as a full
description of any problems encountered since the last progress report.

       The time frames in the  Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing lor me submission oi completed study reports  or
protocols. The noted deadlines run from the date of the receipt of this Notice by the registrant.
If the data are not submitted by the deadline, each registrant is subject to receipt of a Notice of
Intent to Suspend the affected registration(s).

       If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend  to seek additional time to meet the requirements(s), you must  submit a reauest to
the Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates  for meeting such requirements on a step-by-step
oasis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the  testing. While EPA is considering your request, the
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original  deadline remains. Normally, extensions can be requested
only in cases of extraordinary  testing problems beyond  the expectation or control of the
registrant.  Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for  extension  is not made in a timely fashion; in no event shall
an extension  request be considered if it is submitted at or after the lapse of the subject
deadline.

Option 2. Agreement to Share in Cost to Develop Data

       If you choose to enter into an agreement to share in the cost of producing the required
data but will  not be submitting the data yourself, you must provide the name of the registrant
who will be submitting the data. You  must also provide EPA -with documentary evidence that
an agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of the
terms of the  final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties  cannot resolve the terms of the agreement they
may resolve  their differences through binding arbitration.
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 Option 3. Offer to Share in the Cost of Data Development

        If you have made an offer to pay in an attempt to enter into an agreement or amend an
 existing agreement to meet the reguirements of this Notice and have been unsuccessful  you
 may request EPA (by selecting this option) to exercise its discretion not to suspend your
 registration(s), although you do not comply with the data submission requirements of this
 Notice. EPA has determined that as a general policy, absent other relevant considerations it
 will not suspend the registration of a product of a registrant who has in good faith sought and
 continues to seek to enter into a joint data development/cost sharing program, but the other
 registrant(s) developing the data has refused to accept the offer. To qualify for this option you
 must submit documentation to the Agency proving that you have made an offer to another
 registrant (who has an obligation to submit data) to share in the burden of developing that
 data. You must also submit to the Agency a completed EPA Form 8570-32, Certification of
 Otter to Cost Share  in the Development of Data, Attachment 7. In addition, you must
 demonstrate that the other registrant to whom the offer was made has not accepted your offer
 to enter into a C9st-sharmg agreement by including a copy of your offer and proof of the other
 registrant s receipt of that offer (such as a certified mail receipt). Your offer must,  in addition
 to anything else, offer to share in the burden of producing the data upon terms to be agreed to
 or, failing agreement, to be bound by binding arbitration as provided by FIFRA section
 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA of its
 election of an option to develop and submit the data required by this Notice by submitting a
 Data Call-in Response Form and a Requirements Status and Registrant's Response Form
 committing to develop and submit the data required by this Notice.	

       In order for you to avoid suspension under this option, you may not withdraw your
 otter to share in the  burden of developing the data. In addition, the other registrant must fulfill
 its commitment to develop and submit the data as required by this Notice. If the other
 registrant fails to develop the data or for some other reason is subject to suspension your
 registration as well as that of the other registrant normally will be subject to initiation of
 suspension proceedings, unless you commit to submit, and do submit, the required data in the
 specified time frame. In such cases, the Agency generally will not grant a time extension for
 submitting the data.

 Option 4. Submitting an Existing Study

       If you choose to submit an existing study in response to this Notice, you must
 determine that the  study satisfies the requirements imposed by this Notice. You may only
 submit a study that has not been previously submitted to the Agency or previously cited by
 anyone  Existing studies are studies which predate issuance of this Notice. Do not use this
 option if you are submitting data to upgrade a study. (See Option 5).

       You  should be aware that if the Agency determines that the study is not acceptable the
Agency will require you to comply with this Notice, normally without an extension  of the'
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.

      To meet the requirements of the DCI Notice for submitting an existing  study, all  of the
following three criteria must be clearly Met:                                     —^-^

      a.     You must certify at the time that the existing study is submitted that the raw
             data and specimens from the study are available for audit and review and you
             must identify where they are available. This must be done in accordance with
             the requirements of the Good Laboratory Practice (GLP) regulation  40 CFR
             Part 160. As stated in 40 CFR 160.3 'Raw data' means any laboratory
             worksheets, records, memoranda, notes, or exact copies thereof, that are the
             result ot original observations and activities of a study and are necessary for the
                                          171
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             reconstruction and evaluation of the report of that study. In the event that exact
             transcripts of raw data have been prepared (e.g., tapes which have been
             transcribed verbatim, dated,  and verified accurate by signature), the exact copy
             or exact transcript may be substituted for the original source as raw data. 'Raw
             data' may include photographs, microfilm or microfiche copies, computer
             printouts, magnetic media, including dictated observations, and recorded data
             from automated instruments." The term "specimens", according to 40 CFR
             160.3, means "any material derived from a test system for examination or
             analysis."

      b.     Health and safety studies completed after May 1984 also must also contain all
             GLP-required quality assurance and quality control information, pursuant  to the
             requirements of 40 CFR Part 160. Registrants also must certify at the time of
             submitting the existing study that such GLP information is available for post
             May 1984 studies by including an appropriate statement on or attached to the
             study signed by an authorized official or representative of the registrant.

      c.     You must certify that each study fulfills the acceptance criteria for the Guideline
             relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
             Technical Guidance and that the study has  been conducted according to the
             Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG  (both
             available from NTIS). A study not  conducted according to the PAG may be
             submitted to the Agency for consideration  if the registrant believes that the
             study clearly meets the purpose of the PAG.  The registrant is referred to 40
             CFR 158.70 which states the Agency's policy regarding acceptable protocols. If
             you wish to submit the study, you must, in addition to certifying that the
             purposes of the PAG are met by the study, clearly articulate the rationale  why
             you believe the study meets  the purpose of the PAG, including copies of any
             supporting information or data. It has been the Agency's experience that studies
             completed prior to January 1970 rarely satisfied the purpose of the PAG and
             that necessary raw data usually are not available for such  studies.

      If you submit an existing study,  you must certify that the  study meets all requirements
of the criteria outlined above.

      If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed
in the final protocol and study.

      If you know of a study  pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such  study is in the Agency's
files, you need only cite it along with me notification. If not in the Agency's files, you must
submit a summary and  copies as required by  PR Notice 86-5.
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 Option 5. Upgrading a Study

        If a study has been classified as partially acceptable and upgradeable, you may submit
 data to upgrade that study. The Agency will review the data submitted and determine if the
 requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
 be required to submit new data normally without any time extension. Deficient  but
 upgradeable studies will normally be classified as supplemental. However, it is important to
 note that not all studies classified as supplemental are upgradeable. If you have questions
 regarding the classification of a study or whether a study may be upgraded, call or write the
 contact person listed in Attachment 1. If you submit data to upgrade an existing study you
 must satisfy or supply information to correct all deficiencies in the study identified by EPA
 You must provide a clearly articulated rationale of how the deficiencies have been remedied or
 corrected and why the study should be rated as acceptable to EPA. Your submission must also
 specify the MRID number(s) of the study which you are attempting to upgrade and must be in
 conformance with PR Notice 86-5.

       Do not submit additional data for the purpose of upgrading a study classified as
 unacceptable and determined by the Agency as not capabfe of being upgraded.

       This option also should be used to cite data that has been previously submitted to
 upgrade a study, but has not yet been reviewed by  the Agency. You must provide the MRID
 number of the data submission as well as the MRID number  of the study being upgraded.

       The criteria for submitting an existing study, as specified in Option 4 above, apply to
 all data submissions intended to upgrade studies. Additionally,  your submission of data
 intended to upgrade studies must be accompanied by a certification that you comply with each
 of those criteria, as well as a certification regarding protocol compliance with Agency
 requirements.

 Option 6. Citing Existing Studies

       If you choose to cite a study that has been previously  submitted to EPA, that study
 must have been previously classified by EPA as acceptable, or  it must be a study which  has
 not yet been reviewed by the Agency. Acceptable toxicology studies generally will have been
 classified as  core-guideline" or "core-minimum."  For ecological effects studies the
 classification  generally would be a rating of "core." For all other disciplines the classification
 would be acceptable." With respect to any studies for which you wish to select this option
 you must provide the  MRID number of the study you are citing and, if the study has been '
 reviewed by the Agency, you must provide the Agency's classification of the study.

       If you are citing a study of which you are not the original data submitter, you must
 submit a completed copy of EPA Form 8570-31,  Certification with Respect to Data
 Compensation Requirements.	

       2. Product Specific Data

       If you acknowledge on the product specific Data Call-In Response Form that you agree
to satisfy the product specific data requirements (i.e. you select option 7a or 7b) then you
must select one of the six options on the Requirements Status and Registrant's Response  Form
related to data production for each data requirement. Vour option selection should be entered
under item number 9, "Registrant Response." The six options related to data production  are
the first six options discussed under item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form. These six options are listed immediately below with
inlormation in parentheses to guide registrants to additional instructions  provided in this
Section. The options are:
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       (1)    I will generate and submit data within the specified time-frame (Developing
             Data)
       (2)    I have entered into an agreement with one or more registrants to develop data
             jointly (Cost Sharing)
       (3)    I have made offers to cost-share (Offers to Cost Share)
       (4)    I am submitting an existing study that has not been submitted previously to the
             Agency by anyone (Submitting an Existing Study)
       (5)    I am submitting or citing data to upgrade a study classified by EPA as partially
             acceptable and upgradeable (Upgrading a Study)
       (6)    I am citing an existing study that EPA has classified as acceptable or an existing
             study that has been
             submitted but not reviewed by the Agency (Citing an Existing Study)

Option 1. Developing Data -- The requirements for developing product specific data are the
same as those described tor generic data (see Section ffl.C.l, Option 1) except that normally
no protocols or progress reports are required.

Option 2. Agree to Share in Cost to Develop Data - If you enter into an agreement to cost
share, the same requirements apply to product specific data as to generic data (see Section
HI.C.I, Option 2). However, registrants may only choose this option for acute toxicity data
and certain efficacy data and only if EPA has indicated in the attached data tables that your
product and at least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated tor just one of the products in the
group. The registration number of the product for which data will be submitted must be noted
in the agreement to cost share by the registrant selecting this option.

Option 3. Offer to Share in the Cost of Data Development -The same requirements for
generic data (Section 111.(J.I., Option 3) apply to this option. This option only applies to acute
toxicity and certain efficacy data as described in option 2 above.

Option 4. Submitting an Existing Study - The same requirements described for generic data
(see Section Ul.CJ.lT, Uption 4) apply to this option for product specific data.

Option 5. Upgrading a Study - The same requirements described for generic data (see  Section
llf.C.l., Uption 5) apply to this option for product specific data.

Option 6. Citing Existing Studies  — The same requirements described for generic data (see
Section W.CJ.ir, Uption o) apply to this option for product specific data.

       Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, and in me generic data requirements
section (W.CJ.l.), as appropriate.


m-D REQUESTS FOR DATA WAIVERS

        1.     Generic Data

       There are two types of data waiver responses to this Notice. The first  is a request for a
low volume/minor use waiver and the second is a waiver request based on your belief that the
data requirement(s) are not appropriate for your product.
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 a.     Low Volume/Minor Use Waiver

       Option 8 under item 9 on the Requirements Status and Registrant's Response
 Form. Section 3(c)(2)(A) of FIFRA requires tFA to consider the appropriateness ot
 requiring data for low volume, minor use pesticides. In implementing this provision,
 EPA considers low volume pesticides to be only those active ingredients whose total
 production volume for all pesticide registrants is small.  In determining whether to grant
 a low volume, minor use waiver, the Agency will consider the extent, pattern and
 volume of use, the economic incentive to conduct the testing, the importance of the
 pesticide, and the exposure and risk from use of the pesticide. If an active ingredient is
 used for both high volume and low volume uses,  a low volume exemption will not be
 approved. If all uses of an active ingredient are low volume and  the combined volumes
 for all uses  are also low, then an exemption may be granted, depending on review of
 other information outlined below. An exemption will not be granted if any registrant of
 the active ingredient elects to conduct the testing. Any registrant receiving a low
 volume minor use waiver must remain within the sales figures in their forecast
 supporting the waiver request in order to remain qualified for such waiver. If granted a
 waiver, a registrant will be required, as a condition of the waiver, to submit annual
 sales reports.  The Agency will respond to requests for waivers in writing.

       To apply for a low volume, minor use waiver, you must  submit the following
 information, as applicable  to your product(s), as part of your 90-day response to this
 Notice:

       (i).  Total company sales (pounds and dollars) of all registered product(s)
 containing the active ingredient. It applicable to the active ingredient, include foreign
 sales for those products that are not registered in this country but are applied to sugar
 (cane or beet), coffee, bananas, cocoa, and other such crops. Present the above
 information by year for each of the past five years.

       (ii) Provide an estimate of the sales (pounds and dollars) of the active
 ingredient for each major use site. Present the above information by year for each of
 the past five years.

       (iii)  Total direct production cost of product(s) containing the active ingredient
 by year for the past five years. Include information on raw material cost, direct labor
 cost, advertising, sales and marketing,  and any other significant costs listed separately.

       (iv)  Total indirect production cost (e.g. plant overhead, amortized plant and
 equipment) charged to product(s) containing the active ingredient by year for the past
 five years. Exclude all non-recurring costs that were directly related to the active
 ingredient, such as costs of initial registration and any data development.

       (v) A list of each data requirement for which you seek a  waiver. Indicate the
 type of waiver sought and the estimated cost to you (listed separately for each data
 requirement and associated test) of conducting the testing needed to fulfill each of these
 data requirements.

       (vi)  A list of each data requirement for which vou are not seeking any waiver
 and the estimated cost to you (listed separately for each data requirement and associated
 test) of conducting the testing needed to fulfill each of these data  requirements.

       (vii)  For each of the next ten years, a year-by-year forecast of company sales
 (pounds and dollars) of the active ingredient,  direct production costs of product(s)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of product(s) containing the active ingredient (following the

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parameters in item 3 above), and costs of data development pertaining to the active
ingredient.

       (viii) A description of the importance and unique benefits of the active
ingredient to users. Discuss the use patterns and the effectiveness of the active
ingredient relative to registered alternative chemicals and non-chemical control
strategies. Focus on benefits unique to the active ingredient, providing information that
is as quantitative as possible. If you do not have quantitative data upon which to base
your estimates, then present the reasoning used to derive your estimates. To assist the
Agency in determining the degree of importance of the active ingredient in terms of its
benefits, you should provide information on any of the following factors, as applicable
to your product(s): (a) documentation of the usefulness of the active ingredient in
Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient, as opposed to its registered alternatives,
(c) information on the breakdown of the active ingredient after use and on its
persistence in the environment, and (d) description of its usefulness against a pest(s) of
public health significance.

       Failure to submit sufficient information for  the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the
request tor a waiver.

b.     Request for Waiver of Data

       Option 9,  under Item 9, on the Requirements Status and Registrant's Response
Form. This option may be used if you believe that  a particular data requirement should
not apply because the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You also must
submit the current label(s) of your product(s) and,  if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.

       You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice are not appropriate to your
product(s), you will not be required to supply the data pursuant to section 3(c)(2)(B). If
EPA determines that the data are required for your prpduct(s), you must choose a
method ot meeting the requirements ot this Notice within the time trame provided by
this Notice. Within 3U days ot your receipt ot the Agency's written decision, you must
submit a revised Requirements Status and Registrant s Response Form indicating the
option chosen.

2. Product Specific Data

       If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. (Note: any supplemental data must be submitted in the format required by PR
Notice 86-5). This will oe the only opportunity to state the reasons or provide
information in  support of your request.  If the Agency  approves your waiver request,
you will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA. If
the Agency denies your waiver request, you must choose an option for meeting the data
requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the product specific Requirements
Status and Registrant's Response Form. Product specific data requirements tor product
chemistry, acute  toxicity and etlicacy (where appropriate) are  required for all products
and the Agency would grant a waiver only under extraordinary circumstances. You

                                    176
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       should also be aware that submitting a waiver request will not automatically extend the
       due date for the study in question. Waiver requests submitteS"without adequate
       supporting rationale will be denied and the original due date will remain in force.


SECTION IV.       CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
                    INUTICE

IV-A  NOTICE OF INTENT TO SUSPEND

       The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant
to FIFRA section  3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent
to Suspend include, but are not limited to, the following:

       1.     Failure to respond as required by this Notice within 90 days  of your receipt of
             this Notice.

       2.     Failure to submit on the required schedule an acceptable proposed or final
             protocol when such is required to be submitted to the Agency for review.

       3.     Failure to submit on the required schedule an adequate progress report on a
             study as required by this Notice.

       4.     Failure to submit on the required schedule acceptable data as required by this
             Notice.

       5.     Failure to take a required action or submit adequate information pertaining to
             any option chosen to address the data requirements (e.g., any required action or
             information pertaining to submission or citation of existing studies or offers,
             arrangements, or arbitration on the sharing of costs or the formation of Task
             Forces, failure to comply with  the terms of an agreement or arbitration
             concerning joint data development or failure to comply with any terms of a data
             waiver).

       6.     Failure to submit supportable certifications as to the conditions of submitted
             studies, as required oy Section  III-C of this Notice.

       7.     Withdrawal of an offer to share in the cost  of developing required data.

       8.     Failure of the registrant to whom you have tendered an offer to share in the cost
             of developing data and provided proof of the registrant's receipt of such offer
             or failure of a registrant on whom you rely for a generic data exemption  either
             to:

             i. Inform EPA of intent to develop and submit the data required by this Notice
             on a Data  Call-In Response Form and a Requirements Status  and Registrant's
             Response Form.

             ii.  Fulfill the commitment to develop and submit the data as  required by this
             Notice; or

             iii.  Otherwise take appropriate steps to meet the requirements stated in this
             Notice,
                                         177
-------
             unless you commit to submit and do submit the required data in the specified
             time frame.

       9.     Failure to take any required or appropriate steps, not mentioned above, at any
             time following the issuance of this Notice.

IV-B.  BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
       UNACCEPTABLE

       The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but  are not limited to, failure to meet any of the following:

       1)     EPA requirements specified in the Data Call-In Notice or other documents
       incorporated by reference (including, as applicable, EPA Pesticide Assessment
       Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
       regarding the design, conduct, and reporting of required studies. Such requirements
       include, but are not  limited to, those relating to test material, test procedures, selection
       of species, number of animals,  sex and distribution of animals, dose and effect levels to
       be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.

       2)     EPA requirements regarding the submission of protocols, including the
       incorporation or any changes required by the Agency following review.

       3)     EPA requirements regarding the reporting of data, including the manner of
       reporting, the completeness of results, and the  adequacy of any required supporting (or
       raw) data, including, but not limited to, requirements referenced or included in this
       Notice or contained  in PR 86-5. All studies must be submitted in the form of a final
       report; a preliminary report will not be considered to fulfill the submission
       requirement.

IV-C  EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

       EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.

       The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding generally would
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants  permission to sell,  distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances.  Ifypu believe such disposition of existing stocks of your product(s)
which may be suspended for failure to comply with this Notice should be permitted, you have
the burden of clearly demonstrating to EPA that granting such permission would be consistent
with the Act. You also must explain why an "existing  stocks" provision is necessary, including
a statement of the quantity of  existing stocks and your estimate of the time required for their
sale, distribution, and use. Unless you meet this burden, the Agency  will not consider any
request pertaining to the continued sale, distribution, or use of your existing stocks after
suspension.

       If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with  all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of

                                          178
-------
 voluntarily cancelled products containing an active ingredient for which the Agency has
 particular risk concerns will be determined on a case-by-case basis.

       Requests for voluntary cancellation received after the 90 day response period required
 by this Notice will not result in the agency granting any additional time to sell, distribute, or
 use existing stocks beyond a year from the date the 90 day response was due, unless you
 demonstrate to the Agency that you are in full compliance with all Agency requirements,
 including the requirements of this Notice. For example, if you decide to voluntarily cancel
 your registration six months before a 3-year study is scheduled to be submitted, all progress
 reports and other information necessary to establish that you have been conducting the study in
 an acceptable and good faith  manner must have been submitted to the Agency, before EPA
 will consider granting an existing stocks provision.


 SECTION V.       REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
                    UNREASONABLE ADVERSE EFFECTS -

       Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
 pesticide is registered a registrant has additional factual information regarding unreasonable
 adverse effects on the environment by the pesticide, the registrant shall submit the information
 to the Agency. Registrants must notify  the Agency of any tactual information they have, from
 whatever source, including but not limited to interim or preliminary results of studies,
 regarding unreasonable adverse effects  on man or the environment. This requirement
 continues as long as the products are registered by the Agency.


 SECTION VI.      INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the requirements and procedures established by
 this Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status
 Sheet.

       All responses  to this Notice must include completed Data Call-in Response Forms
 (Attachment 2)and completed Requirements Status and Registrant's Response horms
 (Attachment 3), for both (generic and product specitic data) and any other documents required
 by this Notice, and should be submitted to the contact person(s) identified in Attachment 1 .  If
 the voluntary cancellation or generic data exemption option is chosen, only the Generic and
 Product Specific Data Call-In Response Forms need be submitted.

      The Office of Compliance (OC) of the Office of Enforcement and Compliance
 Assurance (OECA), EPA, will be monitoring the data being generated in response to this
 Notice.

                                 Sincerely yours,
                                 Peter Caulkins, Acting Director
                                 Special Review and
                                  Reregistration Division
Attachments


      The Attachments to this Notice are:
                                         179
-------
1 -     Data Call-In Chemical Status Sheet
2 -     Generic Data Call-In and Froduct Specific Data Call-In Response Forms with
       Instructions     "
3 -     Generic Data Call-In and Product Specific Data Call-In Requirements Status
       ana Registrant s Response Forms with instructions
4-     HP A Grouping ot End-Use products for Meeting Acute Toxicology Data
       Requirements tor Keregistration
5 -     fcFA Acceptance uritena
6 -     List ot Registrants Receiving This Notice
7 -     Confidential Statement ot formula, Uost Share and Data Compensation Forms
                                   180
-------
Attachment 1. Chemical Status Sheets
                181
-------
-------
ETHEPHON DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent this Generic Data Call-In Notice because you have product(s)
containing Ethephon.

       This Generic Data Call-In Chemical Status Sheet, contains an overview of data
required by tnis notice, and point ot contact tor inquiries pertaining to the reregistration of
Ethephon. This attachment is to be used in conjunction with (1) the  Generic Data Call-In
Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the Requirements
Status and Registrant's Form (Attachment 2), (4) a list of registrants receiving this DCI
(Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and
Data Compensation Forms in replying to this Ethephon Generic Data Callln (Attachment F)
Instructions and guidance accompany each form.

DATA REQUIRED BY THIS  NOTICE
       ihe additional data requirements needed to complete the generic database for Ethephon
are contained in the Requirements Status and Registrant's Response,  Attachment C.  The
Agency has concluded that additional product chemistry data on Ethephon are needed  These
data are needed to folly complete the reregistration of all eligible Ethephon products.

INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Judy Loranger at (703) 308-8056.

       All responses to this Notice for the generic data requirements should be submitted to:

             Judy Loranger, Chemical Review Manager
             Reregistrati9n Branch
             Special Review and Registration Division (H7508W)
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460
             RE: Ethephon
                                        183
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ETHEPHON DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

      You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing Ethephon.

      This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point ot contact tor inquiries pertaining to the reregistration of
Ethephon. This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Ethephon Product
Specific Data Call-In (Attachment 7).  Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

      The additional data requirements needed to complete the database for Ethephon are
contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency
has concluded that additional data on fcthephqn are needed lor specific products. These data
are required to be submitted to the Agency within the time frame listed. These data are
needed to fully complete the reregistration of all eligible Ethephon products.

INQUIRIES AND RESPONSES TO THIS NOTICE

      If you have  any questions regarding the generic database of Ethephon, please contact
Judy Loranger at (703) 308-8056.

      If you have  any questions regarding the product specific data requirements and
procedures established by  this Notice, please contact Wanda Daughtry at (703) 308-8171.

      All responses to this Notice for the Product Specific data requirements should be
       submitted to:
             Wanda Daughtry
             Chemical Review Manager
             Product Reregistration Branch
             Special Review and Reregistration Branch 7508W
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460

             RE:  Ethephon
                                         184
-------
Attachment 2. Combined Generic and Product Specific
  Data Call-in Response Forms (Form A inserts) Plus
                   Instructions
                       185
-------
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Instructions For Completing The "Data Call-In Response Forms" For The Generic And
Product Specific Data Call-In


INTRODUCTION

These instructions apply to the Generic and Product Specific "Data Call-In Response Forms"
and are to be used by registrants to respond to generic and product specific Data Call-Ins as
part of EPA's Reregistration Program under the Federal Insecticide, Fungicide, and
Rodenticide Act. The type of data call-in (generic or product specific) is  indicated in item
number 3 ("Date and Type of DCI") on each form. BOTH "Data Call-In Response" forms
must be completed.

Although the form is the same for both generic and product specific data, instructions for
completing these forms are different.  Please read these instructions carefully before filling out
the forms.

EPA has developed these forms individually for each registrant, and has preprinted these
forms with a number of items.  DO NOT use these forms for any other active ingredient.

Items 1  through 4 have been preprinted on the form.  Items 5 through 7 must be completed by
the registrant as appropriate.  Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.

The public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this burden, to Chief,
Information Policy Branch, Mail Code 2136, U.S. Environmental  Protection Agency, 401 M
St., S.W., Washington, D.C. 20460; and to the Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
                                         187
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specitic Data (Jail-In


Item 1 .ON BOTH FORMS: This item identifies your company name, number and address.

Item 2.ON BOTH FORMS: This item identifies the case number, case name, EPA chemical
number and chemical name.

Item 3.ON BOTH FORMS: This item identifies the type of Data Call-In. The date of
issuance is date stamped.

Item 4.ON BOTH FORMS: This item identifies the EPA product registrations relevant to
the data call-in. Please note that you are also responsible for informing the Agency of your
response regarding any product that you believe may be covered by this Data Call-In but that
is not listed by the Agency in Item 4. You must bring any such apparent omission to the
Agency's attention within the period required for submission of this response form.

Item 5.ON BOTH FORMS: Check this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of that request. Since this Data Call-In
requires both generic and product specific data, you must complete item 5 on both Data Call-
in response forms.  You  do not need to complete any item on the Requirements Status and
Registrant's Response Forms.

Item 6a.ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
generic data as indicated in Item 3 and you are eligible for a Generic Data Exemption for the
chemical listed in Item 2 and used in the subject product.  By electing this exemption, you
agree to the terms and  conditions of a Generic Data Exemption as explained in the Data
Call-in Notice.

If you are eligible for or claim a Generic Data Exemption, enter the EPA registration Number
of each registered source of that active ingredient that you use in your product.

Typically, if you purchase an EPA-registered product from one or more other producers
(wno, with respect to the incorporated product, are in compliance with this and any other
outstanding Data Call-In Notice), and


INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Ueneric and Product Specitic Data Call-In


incorporate that product  into all your products, you may complete this item for all products
listea on this  form. If,  however, you produce the active ingredient yourself, or use any
unregistered product (regardless of the fact that some of your sources are registered), you may
not claim a Generic Data Exemption and you may not select this item.

Item 6b.ON THE GENERIC  DATA FORM:  Check this Item if the  Data Call-In is for
generic data as indicated in Item 3 and if you are agreeing to satisfy the generic data
requirements of this Data Call-In. Attach the Requirements Status and Registrant's Response
Form that indicates how  you will satisfy those requirements.
                                         188
-------
NOTE: Item 6a and 6b are not applicable for Product Specific Data.

Item 7a.ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing use
product (MUP) for which you wish to maintain registration, you must agree to satisfy the data
requirements by responding "yes."

Item Tb.For each end use product (EUP) for which you wish to maintain registration,  you
must agree to satisfy the data requirements by responding "yes."

FOR BOTH MUP and EUP products

You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if your product
is identical to another product and you qualify for a data exemption.   You must provide the
EPA registration numbers of your source(s); do not complete the Requirements Status and
Registrant's Response form.  Examples of such products include repac
O   *  1 T    1 V T  1/fl  j *   /% .J V    1   ..  1*1     • i   •   i   f* «
                                                               ickaged products and
Special Local Needs (Section 24c) products which are identical to federally registered
products.

If you are requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with option 7 (Waiver
Request) for each study for which you are requesting a waiver.

NOTE: Item 7a and 7b are not applicable  for Generic Data.


INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Uenenc and Product Speciric Data Call-in


Item 8.ON BOTH FORMS: This certification statement must be signed by an authorized
representative of your company and the. person signing must include his/her title.  Additional
pages used in your response must be initialled and dated in the space provided for the
certification.

Item 9.ON BOTH FORMS: Enter the date of signature.

Item 10.ON BOTH FORMS:  Enter the name of the person EPA should contact with
questions regarding your response.

Item 11 .ON BOTH FORMS:  Enter the phone number of your company contact.
   Note:    You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you
          may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
          product. For these cases, please supply all relevant details so that EPA can ensure that its records are correct.
                                         189
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Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms (Form B inserts)
and Instructions
                         191
-------
-------
                               Instructions For Completing
                                          The
                  "Requirements Status and Registrant's Response Forms"
                    For The Generic and Product Specific Data Call-In


INTRODUCTION

       These instructions apply to the Generic and Product Specific "Requirements Status and
Registrant's Response Forms" and are to be used by registrants to respond to generic and
product specific Data Call-in's as part of EPA's reregistration program under the Federal
Insecticide, Fungicide, and Rodenticide Act. The type of Data Call-In (generic or product
specific) is indicated in item number 3 ("Date and Type of DCI") on each form.  Both
"Requirements Status and Registrant's Response" forms must be completed.

       Although the  form is the same for both product specific and generic data, instructions
for completing the forms differ slightly.  Specifically,  options for satisfying product specific
data requirements do not include (1) deletion of uses or (2) request for a low volume/minor
use waiver.  Please read these instructions carefully before filling out the forms.

       EPA has developed these forms individually for each registrant, and has preprinted
these forms to include certain information unique to this chemical. DO NOT use these forms
for any other active ingredient.                                 	

       Items  1 through 8 have been preprinted on the form. Item 9 must be completed by the
registrant as appropriate. Items 10 through  13 must be completed by  the registrant before
submitting a response to the Agency.

       The public reporting burden for this collection of information is estimated to average
30 minutes per response, including time for  reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of
this collection of information, including  suggestions for reducing  this burden, to Chief
Information Policy Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M
St., S.W., Washington, D.C.  20460;  and to the Office of Management and Budget
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503
                                         193
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
KfcUlS 1 KANT' S RfcSFON Sb hORMS "
Ueneric and Product Specitic Data (Jail-In


Item 1.       ON BOTH FORMS: This item identifies your company name, number and
             address.

Item 2.       ON THE GENERIC DATA FORM:  This item identifies the case number,
             case name, EPA chemical number and chemical name.

             ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
             case number, case name, and the EPA Registration Number of the product for
             which the Agency is requesting product specific data.

Item 3.       ON THE GENERIC DATA FORM:  This item identifies the type of Data
             Call-in.  The date of issuance is date stamped.

             ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the type
             of Data Call-In. The date of issuance is also date stamped.  Note  the unique
             identifier number (ID#) assigned by the Agency.  This ID number must be used
             in the transmittal document for any data submissions in response to this Data
             Call-In Notice.

Item 4.       ON BOTH FORMS: This item identifies the guideline reference number of
             studies required. These guidelines, in addition to the requirements specified in
             the Data Call-In Notice, govern the conduct of the required studies.  Note that
             series 61  and 62 in product chemistry are now listed under 40 CFR 158.155
             through 158.180, Subpartc.

Item 5.       ON BOTH FORMS: This item identifies the study title associated with the
             guideline reference number and whether protocols and 1, 2, or 3-year progress
             reports are required to be submitted in connection with the study.  As nptea in
             Section IQ of the Data Call-In Notice, 90-day progress reports are required for
             all studies.

             If an asterisk appears in Item 5, EPA has attached information relevant to  this
             guideline reference number to the Requirements Status and Registrant's
             Response Form.
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"	
Ueneric and Product Specitic Data Call-in

Item 6.      ON BOTH FORMS: This item identifies the code associated with the use
            pattern of the pesticide. In the case of efficacy data (product specific
            requirement), the required study only pertains to products which have the use
            sites and/or pests indicated.  A brier description of each code follows:

            A     Terrestrial food
            B     Terrestrial feed
            C     Terrestrial non-food
                                       194
-------
 Item 7.
Item 8.
 D     Aquatic food
 E     Aquatic non-food outdoor
 F     Aquatic non-food industrial
 G     Aquatic non-food residential
 H     Greenhouse food
 I      Greenhouse non-food crop
 J      Forestry
 K     Residential
 L     Indoor food
 M     Indoor non-food
 N     Indoor medical
 O     Indoor residential

 ON BOTH FORMS:  This item identifies the code assigned to the substance
 that must be used for testing. A brief description of each code follows:

                   End-Use Product
                   Manufacturing-Use Product
                   Manufacturing-Use Product and Technical  Grade Active
                   Ingredient
                   Pure Active Ingredient
                   Pure Active Ingredient and Metabolites
                   Pure Active Indredient or Pute Active
                   Ingredient Radiolabelled
                   Pure Active Ingredient Radiolabelled
                   Pure Active Ingredient Radiolabelled and Metabolites
                   Pure Active Ingredient Radiolabelled and Plant
                   Metabolites
                   Typical End-Use Product
                   Typical End-Use Product, Percent Active Ingredient
                   Specified
                   Typical End-Use Product and Metabolites
                   Typical End-Use Product or Pure Active Ingredient and
                   Metabolites
                   Technical Grade Active Ingredient
                   Technical Grade Active Ingredient or Pure Active
                   Ingredient
                   Technical Grade Active Ingredient or Pure Active
                   Ingredient    Radiolabelled
                   Technical Grade Active Ingredient or Typical End-Use
                   Product
                   Metabolites
                   Impurities
                   Degradates
*                  See: guideline comment

This item completed by the Agency identifies the time frame allowed for
submission  of the study or protocol  identified in item 5.

ON THE GENERIC DATA FORM:  The time frame runs from the date of
your receipt of the Data Call-In notice.

ON THE PRODUCT SPECIFIC DATA FORM:  The due date for
submission of product specific studies begins from the date stamped on the letter
transmitting the Reregistration Eligibility Decision document, and not from the
             EUP
             MP
             MP/TGAI

             PAI
             PAI/M
             PAI/PAIRA

             PAIRA
             PAIRA/M
             PAIRA/PM

             TEP
             TEP    %
             TEP/MET
             TEP/PAI/M

             TGAI
             TGAI/PAI

             TGAI/PAIRA

             TGAI/TEP

             MET
             IMP
             DEGR
                                        195
-------
             date of receipt. However, your response to the Data Call-In itself is due 90
             days from the date of receipt.

Item 9.       ON BOTH FORMS:  Enter the appropriate Response Code or Codes to show
             how you intend to comply with each data requirement. Brief descriptions of
             each code f9llow. The  Data Call-In Notice contains a fuller description of each
             of these options.

       Option 1.     ON BOTH FORMS: (Developing Data) I will conduct a new study and
                    submit it within the time frames specitied in item 8 above.  By indicating
                    that I have chosen this option, I certify that I will comply with all the
                    requirements pertaining to the conditions for submittal of this study as
                    outlined in the Data Call-In N9tice and that I will provide the protocols
                    and progress reports required in item 5  above.

       Option 2.     ON BOTH FORMS: (Agreement to Cost Share) I have entered into an
                    agreement with one or more registrants to develop data jointly. By
                    indicating that I have chosen this option, I certify that I will comply with
                    all the requirements pertaining to snaring in the cost of developing data
                    as outlined in the Data Call-In Notice.

                           However, for Product Specific Data, I understand that this
                    option is available for acute toxicity or certain efficacy data ONLY if
                    the Agency indicates in an attachment to this notice that my product is
                    similar enough  to another product to qualify  for this option. I certify that
                    another party in the agreement is committing to submit or provide  the
                    required data; if the required study is not submitted on time, my product
                    may be subject  to suspension.

       Option 3.     ON BOTH FORMS:  (Offer to Cost Share) I have made an offer to
                    enter into an agreement with one or more registrants to develop data
                    jointly. I am also submitting a completed "Certification of offer to Cost
                    Share in the Development of Data" form.  I am submitting evidence that
                    I have made  an offer to another registrant (who has an obligation to
                    submit data)  to share in the cost of that data. I am including a copy of
                    my offer and proof of the other registrant's receipt of that  offer. I am
                    identifying the party which is committing to  submit or provide the
                    required data; if the required study is not submitted on time, mv product
                    may be subject to suspension. I understand that other terms under Option
                    3 in the Data Call-In Notice apply as well.

                           However, for Product Specific Data,  I understand that this
                    option is available only for acute toxicity or certain efficacy data and
                    only if the Agency indicates in an attachment to this Data Call-in Notice
                    that my product is similar enough to another product to qualify for this
                    option.

       Option 4.     ON BOTH  FORMS:  (Submitting Existing  Data)  I will submit an
                    existing study by the specified due date that has never before been
                    submitted to EPA.  By indicating that I have chosen this option, I certify
                    that this study meets all the requirements pertaining to the  conditions for
                    submittal  of existing data outlined in the Data Call-in Notice and I have
                    attached the needed supporting information along with this response.
                                          196
-------
 Options.     ON BOTH FORMS: (Upgrading a Study)  I will submit by the
              specified due date, or will cite data to upgrade a study that EPA has
              classified as partially acceptable and potentially  uperadeable. By
              indicating that I have chosen this option, I certify that I have met all the
              requirements pertaining to the conditions for submitting or citing
              existing data to upgrade a study described in the Data Call-in Notice. I
              am indicating on attached correspondence the Master Record
              Identification Number (MRID) that EPA has assigned to the data that I
              am citing as well as the MRID of the study I am attempting to upgrade.

 Option 6.     ON BOTH FORMS: (Citing a Study) I  am citing an existing study
              that has been previously classified by fcPA as acceptable, core, core
              minimum,  or a study tnat has not yet been reviewed by the Agency. If
              reviewed, I am providing the Agency's classification of the study.

                    However, for Product Specific Data, I am citing another
              registrant's study.  I understand that this option  is  available ONLY for
              acute toxicity or certain efficacy data and ONLY if the cited study was
              conducted on my product, an identical product or a product which the
              Agency has "grouped" with one or more other products for purposes of
              depending on the same data. I may also choose this option if I am citing
              my own data. In either case, I will provide the MRID or Accession
              number (s). If I cite another registrant's data, I  will submit a completed
              "Certification With Respect To Data Compensation Requirements
              form.

 FOR THE GENERIC DATA FORM ONLY: The following three options
 (Numbers 7, 8, and 9) are responses that apply only to the "'Requirements Status
 and Registrant's Response Form" for generic data.

 Option 7.     (Deleting Uses) I am attaching an application for amendment to my
              registration deleting the uses for which the data are required.

 Option 8.     (Low Volume/Minor Use Waiver Request) I have read the statements
              concerning low volume-minor use data waivers in the Data Call-In
              Notice and I request a low-volume minor use waiver of the data
              requirement. I am attaching  a detailed justification to support this waiver
              request including, among  other things, all information required to
              support the request.  I understand that, unless modified by the Agency in
              writing, the data requirement as  stated in the Notice governs.

 Option 9.     (Request for Waiver of Data) I have read the statements concerning data
              waivers otner than lowvolume minor-use data  waivers in the Data
              Call-In Notice and I request a waiver of the data requirement. I am
              attaching a  rationale explaining why I believe the data requirements do
              not apply. I am also submitting a copy of my current labels. (You must
              also submit a copy of your Confidential Statement of Formula if not
             already on file with EPA). I understand that, unless modified by the
             Agency in writing, the data requirement as stated in the Notice governs.

FOR PRODUCT SPECIFIC DATA: The following option (number 7) is a
response that applies to the "Requirements Status and Registrant's Response
Form" for product specific data.
                                  197
-------
       Option 7.      (Waiver Request) I request a waiver for this study because it is
                     inappropriate lor my product. I am attaching a complete justification for
                     this request, including technical reasons, data and references to relevant
                     EPA regulations, guidelines or policies. [Note: any supplemental data
                     must be submitted in the format required by P.R. Notice 86-5]. I
                     understand that this is my only opportunity to state the reasons or
                     provide information in support of my request. If the Agency approves
                     my waiver request, I will not be required to supply the data pursuant to
                     Section 3(c) (2) (B) of FIFRA. If the Agency denies my waiver request,
                     I must choose a method of meeting the data requirements of this Notice
                     by the due date stated by this Notice. In this case, I must, within 30
                     days-of my receipt of the Agency's written decision, submit a revised
                     "Requirements Status" form specifying the option chosen. I also
                     understand that the deadline for submission of data as specified by the
                     original Data Call-In notice will not change.

Item 10.      ON BOTH FORMS: This item must be signed by an authorized representative
              of your company. The person signing must include his/her title, and must initial
              and date all other pages of this form.

Item 11.      ON BOTH FORMS: Enter the date of signature.

Item 12.      ON BOTH FORMS: Enter the name of the person EPA should contact with
              questions  regarding your response.

Item 13.      ON BOTH FORMS: Enter the phone number of your company contact.
    NOTE:   You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example,
          you may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled
                                            198
-------
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Attachment 4. EPA Batching of End-Use Products for
   Meeting Data Requirements for Registration
                      199
-------
-------
 EPA'S BATCHING OF ETHEPHON PRODUCTS FOR MEETING ACUTE TOXICITY
 DATA REQUIREMENTS FOR REREGISTRATION     imillNO A^u ^ IUAIUII Y

        In an effort to reduce the time, resources and number of animals needed to fulfill the
 acute toxicity data requirements for reregistration of products containing ethephon as the
 active ingredient, the Agency has batched products which can be considered similar for
 purposes of acute toxicity. Factors  considered in the sorting process include each product's
 active and inert ingredients (identity, percent composition and biological activity)  type of
 formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc )  and
 labeling (e.g., signal word, use classification, precautionary labeling, etc.).  Note that the
 Agency is not describing batched products as "substantially similar" since some products
 within a batch may not be  considered chemically similar or have identical use patterns.

        Using available information, batching has been accomplished by the process described
 in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the
 right to require, at any time,  acute  toxicity data for an individual product should the need
 arise:
 arise.
       Registrants of products within a batch may choose to cooperatively generate, submit or
 cite a single battery of six acute toxicological studies to represent all the products within that
 batch. It is the registrants' option to participate in the process with all other registrants, only
 some ot the other registrants,  or only their own products within a batch, or to generate all the
 required acute toxicological studies For each of their own products. If a registrant chooses to
 generate the data for a batch, he/she must use one of the products within the batch as the test
 material.  If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
 may do so provided that the data base is complete and valid by today's standards (see
 acceptance criteria attached), the formulation tested is considered by EPA to be similar for
 acute toxicity, and the formulation has not been significantly altered since submission and
 acceptance of the acute toxicity data. Regardless of whether new data is generated or existing
 data is referenced, registrants  must clearly identify the test material by EPA Registration
 Number. If more than one confidential statement of formula (CSF) exists for a product the
 registrant must indicate the formulation actually tested by identifying the corresponding CSF.

 .u  A- In.decid!ng how to meet the product specific data requirements, registrants must follow
 the directions given in the Data Call-In Notice and its attachments appended to the RED  The
 DCI Notice contains two response forms which are to be completed and submitted to the
 Agency within 90 days of receipt.  The first form, "Data Call-in Response," asks whether the
 registrant will meet the data requirements  for each product.  The second form, "Requirements
 Status and Registrant's Response," lists the product specific data required for each product
 including the standard six acute toxicity tests. A registrant who wishes to participate in a  '
 batch must decide whether he/she will provide the data or depend on someone else to do so
 It a  registrant supplies the data to support a batch of products, he/she must select one of the
 following options: Developing Data (Option 1), Submitting an Existing Study (Option 4)
 Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a registrant
 depends on another s data, he/she must choose among: Cost Sharing (Option 2), Offers to
 Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to
 participate in a batch, the choices  are Options 1, 4,  5 or 6. However,  a registrant should
 know that closing not to participate in a batch  does not preclude other registrants in the batch
 trom citing his/her studies and offering to cost share (Option 3) those studies.

       Twenty products were found which contain ethephon as the active ingredient  The
products have been placed into 5 batches in accordance with the active and inert ingredients
type of formulation and current labeling. Table  1 identifies the products in each batch
                                          201
-------
Table 1
Batch
1
2
3
4
5
EPA Reg. No.
264-263
264-543
CA90002800
264-267
264-292
264-376
AZ87002100
CA76019400
CA83003400
VA83001700
264-257
264-377
264-380
HI84000400
ffl94000400
PR89000200
264-418
56077-49
264-511
56077-50
% Active Ingredient
3.9
3.9
3.9
21.7
21,7
21.7
21.7
21.7
21.7
21.7
39.9
39.9
39.9
39.9
39.9
39.9
55.4
55.4
71.3
71.3
Formulation
Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
                                       202
-------
Attachment 5. EPA Acceptance Criteria
                203
-------
-------
                                   SUBDIVISION D
Guideline            Study Title

Series 61            Product Identity and Composition
Series 62            Analysis and Certification of Product Ingredients
Series 63            Physical and Chemical Characteristics
                                        205
-------
                                   61 Product Identity and Composition


 ACCEPTANCE CRITERIA


 Does your study meet the following acceptance criteria?

 1 •	    Name of technical material tested (include product name and trade name, if appropriate).

 2-	    Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
           intentionally-added inert ingredient.

 3-	    Name and upper certified limit for each impurity or each group of impurities present at  > 0.1 % by
           weight and for certain lexicologically significant impurities (e.g., dioxins, nitrosaminesfpresent at
           ^U. 1 fQ .

 4.	    Purpose of each active ingredient and each intentionally-added inert.

 5-	    Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
           Registry Number for each active ingredient and, if available, for each intentionally-added inert.

 6-	    Molecular, structural, and empirical formulas, molecular weight or  weight range, and any company
           assigned experimental or internal code numbers  for each active ingredient.

 7-	    Description of each beginning material in the manufacturing process.
           	  EPA Registration Number if registered;
                 for other beginning materials, the following:
           	  Name and address of manufacturer or supplier.
           	  Brand name, trade name or commercial designation.
           	  Technical specifications or data sheets by which manufacturer or supplier describes composition
                 properties or toxicity.                                                                    '

 8.	Description of manufacturing process.
           	  Statement of whether batch or continuous process.
           	  Relative amounts of beginning materials and order in which they are added
           	  Description of equipment.
           	  Description of physical conditions (temperature, pressure, humidity) controlled in each step and
                 the parameters that are maintained.
           	  Statement of whether process involves intended chemical reactions.
           	  Flow chart with chemical equations for each intended chemical reaction
           	  Duration of each step of process.
           _,	  Description of purification procedures.
           	  Description of measures taken to assure quality of final product.

9-	    Discussion of formation of impurities based on established chemical  theory addressing (1) each impurity
           which may be present at  >  0.1 % or was found at > 0.1 % by product analyses and (Z) certain
           lexicologically significanfTmpurities (see #3).
                                                  206
-------
                            62 Analysis and Certification of Product Ingredients


                                         ACCEPTANCE CRITERIA

The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to
present the information in items 6, 7, and 8.

Does your study meet the following acceptance criteria?

 1 •	   Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
          and all impurities present at > 0.1 %.
 2.	   Degree of accountability or closure > ca98%.
 3-	   Analyses conducted for certain trace~loxic impurities at lower than 0.1 % (examples, nitrosamines in the
          case of products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus
          nitrites;  polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines Doth
          fresh and stored samples must be analyzed.].
 4.	   Complete and detailed description of each step in  analytical method used to analyze above samples.
 5.	   Statement of precision and accuracy of analytical method used to analyze above samples.
 6.	   Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
 /.	   Upper and lower certified limits proposed for each active ingredient and intentionally added inert along
          with explanation of how the limits were determined.
 8.	   Upper certified limit proposed for each impurity present at > 0.1 % and for certain lexicologically
          significant impurities at <0.1 % along with explanation of Row limit determined.
 9.	   Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if
          exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
!0.	   Analytical methods (as discussed in #9) to verify certified limits validated as to  their precision and
          accuracy.
                                                  207
-------
                                  63 Physical and Chemical Characteristics

                                         ACCEPTANCE CRITERIA


 The following criteria apply to the technical grade of the active ingredient being reregistered.

 Does your study meet the following acceptance criteria?

 63-2 Color
    	  Verbal description of coloration (or lack of it)
    	  Any intentional coloration also reported in terms of Munsell color system

 63-3 Physical State
    	  Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
    	  Based on visual inspection at about 20-25° C

 63-4 Odor
    	  Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
           compounds
    	  Observed at room temperature

 63-5 Melting Point
    	  Reported in °C
    	  Any observed decomposition reported

 63-6 Boiling Point
    	  Reported in °C
    	  Pressure under which B.P. measured reported
    	  Any observed decomposition reported

 63-7 Density, Bulk Density, Specific Gravity
    	  Measured at about 20-25° C
    	  Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported
           with reference to water at 20° C. [Note: Bulk density of regisfered products may be reported in lbs/ft3
           or Ibs/gallon.]                        	                                     r

 63-8 Solubility
    	  Determined in distilled  water and representative polar and non-polar solvents, including those used in
           formulations and analytical methods for the pesticide
    	  Measured at about 20-25° C
    	  Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)

 63-9 Vapor Pressure
    	  Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if
           pressure too low to measure at 25° C)                                        or
    	  Experimental procedure described
    	  Reported in mm Hg (torr) or other conventional  units

 63-10 Dissociation Constant
    	  Experimental method described
    	  Temperature of measurement specified (preferably about
           20-25 °C)                                    '

 63-11 Octanol/water Partition Coefficient
    	  Measured at about 20-25° C
    	  Experimentally determined and description of procedure provided (preferred method-45 Fed. Register

    	  Data supporting reported value provided

63-12 pH
    	   Measured at about 20-25° C
    	   Measured following dilution or dispersion in distilled water

63-13 Stability
    	   Sensitivity to metal ions and metal determined
    	   Stability at normal and elevated temperatures
    	   Sensitivity to sunlight determined
                                                   208
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                                           SUBDIVISION F


Guideline         Study Title

 81-1           Acute Oral Toxicity in the Rat
 81-2           Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
 81-3           Acute Inhalation Toxicity in the Rat
 81-4           Primary Eye Irritation in the Rabbit
 81-5           Primary Dermal Irritation Study
 81-6           Dermal Sensitization in the Guinea Pig
                                                209
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                                    81-1  Acute Oral Toxicity in the Rat


                                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1. _ Identify material tested (technical, end-use product, etc).
 2. _ At least 5 young adult rats/sex/group.
 3.,, _ Dosing, single oral may be administered over 24 hrs.
 4. _ Vehicle control if other than water.
o.
                                        .
        Doses tested, sufficient to determine a toxicity category or a limit dose (5000 me/kg).
        Individual observations at least once a day.
        Observation period to last at least 14 days, or until all test animals appear normal whichever is longer
        Individual daily observations.                                                                6  '
  _
9. _ Individual body weights.
10. _ Gross necropsy on all animals.
                    Criteria marked with an * are supplemental and may not be required for every study.
-------
                        81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig


                                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

         Identify material tested (technical, end-use product, etc).
         At least 5 animals/sex/group.
         Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
         Dosing, single dermal.
         Dosing duration at least 24 hours.
         Vehicle control, only if toxicity of vehicle is unknown.
         Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg)
         Application site clipped or shaved at least 24 hours  before dosing.
         Application site at least 10% of body surface area.
         Application  site covered with  a porous nonirritating cover to retain test material and to prevent
                 mgestion.                                                                r
         Individualobseryations at least once a day.
         Observation period to last at least 14 days.
         Individual body weights.
         Gross necropsy on all animals.
                    Criteria marked with an * are supplemental and may not be required for every study.
-------
                                 81-3 Acute Inhalation Toxicity in the Rat


                                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2-	 Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use
        or contains particles of mhalable size for man (aerodynamic diameter 15 urn or less).
 3.	At least 5 young adult rats/sex/group.
 4.	 Dosing, at least 4 hours by inhalation.
 5-	Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content
 6.	Chamber temperature, 22° C (±2°), relative humidity 40-60%.
 7.	 Monitor rate of air flow.
 8.	 Monitor actual concentrations of test material in breathing zone.
 9.	 Monitor aerodynamic particle size for aerosols.
10-	  Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
        respirable substance).
11.	  Individual observations at least once a day.
12.	  Observation period to last at least 14 days.
13.	  Individual body weights.
14.	  Gross necropsy on all animals.
                                                 212
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                                 81-4  Primary Eye Irritation in the Rabbit


                                         ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1-	Identify material tested (technical, end-use product, etc).
 2.	 Study not required if material is corrosive, causes severe
        dermal irritation or has a pH of  <2 or > 11.5.
 3.	6 adult rabbits.                —    —
 4.	 Dosing, instillation into the conjunctival sac of one eye
        per animal.
 5-	P0.86' O-1 ml if a liquid; 0.1  ml  or not more than 100 mg if a solid, paste or particulate substance
 o.	bond or granular test material ground to a fine dust.
 7.	Eyes not washed for at least 24 hours.
 8.	 Eyes examined and graded for irritation before dosing and
        at 1, 24, 48 and 72 hr, then daily until eyes are normal
        or 21 days (whichever is shorter).
 9.*	 Individual daily observations.
                    Criteria marked with an * are supplemental and may not be required for every study.
                                                   ^ 1.3
-------
                                   81-5 Primary Dermal Irritation Study

                                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1-	 Identify material tested (technical, end-use product, etc).
 2.	 Study not required if material is corrosive or has a pH of < 2 or > 11.5.
 3.	 6 adult animals.                                       —    —
 4.	 Dosing, single dermal.
 5.	 Dosing duration 4 hours.
 6.	 Application site shaved or clipped at least 24 hours prior to dosing.
 7.	 Application site approximately 6 cm2.
 8-	 Application site covered with a gauze patch held in place with nonirritating tape
 9.	 Material renroved, washed with water, without trauma to application site
10-	  Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14
        days (whichever is shorter).
11 .*	  Individual daily observations.
                    Criteria marked with an * are supplemental and may not be required for every study.
-------
                                81-6 Dermal Sensitization in the Guinea Pig

                                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

1.	Identify material tested (technical, end-use product, etc).
2.    Study not required if material is corrosive or has a
      pHof <2or >11.5.
3.	One ofThe following methods is utilized:
      	Freund's complete adjuvant test
      	Guinea pig maximization test
      	Split adjuvant technique
      	Buehler test
      	Open epicutaneous test
      	Mauer optimization test
             Footpad technique in guinea pig.
4.    Complete description of test.
5.*   Reference for test.
6.	Test followed essentially as described in reference document.
7.	 Positive control included (may provide historical data conducted within the last 6 months).
                    Criteria marked with an * are supplemental and may not be required for every study.
-------
-------
Attachment 6. List of All Registrants Sent This Data Call-in (insert)
                             Notice
                              217
-------
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Attachment 7. Cost Share Data Compensation Forms, Confidential
         Statement of Formula Form and Instructions
                           219
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-------
-------
                Instructions for Completing the Confidential Statement of Formula
 The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form
                               are required.  Following are basic instructions:
                   a. All the blocks on the form must be filled in and answered completely.
                               b. If any block is not applicable, mark it N/A.
     c. The CSF must be signed, dated and the telephone number of the responsible party must be provided.
    d. All applicable information which is on the product specific data submission must also be reported on the
                                                 CSF.
 e.All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet for solids.
                  f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
 g.For all active ingredients, the EPA Registration Numbers for the currently registered source products must be
                                       reported under column 12.
 h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for the trade
                                        names must be reported.
i.For the active ingredients, the percent purity of the source products must be reported under column  10 and must
. A „ ,,      ...    ,       op exactly the same  as on the source product's label.
j. All the weights m columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will volumes be
             accepted. Do not mix English and metric system units  (i.e., pounds and kilograms).
                        k. All the items under column 13.b. must total 100 percent.
     1.A11 items under columns  14.a. and 14.b. for the active ingredients must represent pure active  form.
  m. The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158 175
 instructions. An explanation must be provided if the proposed limit? are different than standard certified limits.
 n. When new CSFs are submitted and approved, all previously submitted CSFs become  obsolete for that specific
                                             formulation.
                                                 223
-------
-------
     &EPA
United States Environmental Protection Agency
            Washington, DC 20460
   CERTIFICATION  OF OFFER TO COST
SHARE  IN THE DEVELOPMENT OF  DATA
Form Approved

OMB No.  2070-0106
         2070-0057
Approval  Explras 3-31-96
  Public reporting burden for this collection of information is estimated to average 15 minutes per response including
  time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed and
  completing and reviewing the collection of information.  Send comments regarding the burden estimate or any other
  aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
  Branch, PM-223. U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
  of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

  Please fill  in blanks below.
Company Nnme

Company Number
EPA Reg. No.
 I  Certify that:

 My company is willing to develop and submit the data required by EPA under the authority of the Federal
 Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
 enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
 data.

 My firm has offered in writing to enter into such an agreement.  That offer was  irrevocable and included an
 offer to be bound by arbitration decision under section 3(c)(2)(B)(Iii) of FIFRA if final agreement on all
 terms could not be reached otherwise.  This offer was made to the following firm(s) on the following
 date(s):
  Nam* of Flrnt(t)
                                                                            Oat* of Offtr
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I  have made on
this form and all attachments therein are tiue, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or Imprisonment or both under applicable law.
 Signs tur* of Company's Authorized Rapr*aantativ*
                                                                           Dal*
 Nam* and Tltl« (Picas* Typ* or Print)
EPA Form 8570-32 (5/91)   Replace* EPA Form 8580, which Is obsolete
                                                225
-------
-------
                       United States Environmental Protection Agency
                                   Washington, DC 20460
                            CERTIFICATION WITH RESPECT TO
                          DATA COMPENSATION REQUIREMENTS
                                                                   Form Approved
                                                                   OMB No. 2070-0107,
                                                                   2070-0057
                                                                   Approval Expires
                                                                   3-31-96
 Public reporting! burden for this collection of information is estimated to average 15 minutes per response  includina time for
 SfflS'Sf^SAJJ881?11!? existing *data 'ources gathering and maintaining the ^Sn^S^^^^f^rS
 col ection of information. Send comments regarding the burden estimate or any other aspect of th is collection of Sformation
 AnlUn(i!n9/nU^aelt*loncSxS?r E,du£nQthis burden to. Chief Information Policy Branch, PM-213 U S Environm^
                                           '     t0 the °ffiCe °f Manaaement and Bud9et- PaperWork 1 Reduction Project
                                                                                      th
 Please fill in blanks below.
 Company Name
                                                                                             Company Number
 Product Name
                                                                                             EPA Reg. No.
  Certify that:
        *ua?'? study ci.ted- in suPPort of registration or reregistratiion under the Federal Insecticide  Funaicide and Rodenticide
        m^?ton(£%ra       dVl ' 3m the °riginal data submitter- or ' have obtained the wriherP9e?miss1Sn of^heorigin
                   dy         "
         of registration or reregistration under FIFRA that is NOT an exclusive use study lam the
         "HfA^nJ^wKSf118^0/1 °/ \hloriginal data submitter, or I have notified in writing the
         & r«m^L™e«offe*?d*-to: *(aLPav compensation for those data in accordance wrth section
arnA.Tnr^^0^"161!06 n.e9ot!ftlon to determine which data are subject to the compensation
amount of compensation due, if any.  The companies I have notified are (check one)
                                                   °n the back of this form or attached sheets-
                        complied with section 3
-------
-------
APPENDIX G. FACT SHEET
         229
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-------
                 United States
                 Environmental Protection
                 Aflency	
                       Prevention, Pesticide*
                       And Toxic Substances
                       (7508 W)
EPA-738-F-95-004
April 1995
                 R.E.D.  FACTS
                 Ethephon
     Pesticide
Reregistration
   Use Profile
   Regulatory
       History
     All pesticides sold or distributed in the United States must be
 registered by EPA, based on scientific studies showing that they can be used
 without posing unreasonable risks to people or the environment. Because of
 advances in scientific knowledge, the law requires that pesticides which
 were first registered years ago be reregistered to ensure that they meet
 today's more stringent standards.
     In evaluating pesticides for reregistration, EPA obtains and reviews a
 complete set of studies from pesticide producers, describing the human
 health and environmental effects of each pesticide. The Agency imposes
 any regulatory controls that are needed to effectively manage each
 pesticide's risks. EPA then reregisters pesticides that can be used without
 posing unreasonable risks to human health or the environment.
     When a  pesticide is eligible for reregistration, EPA announces this and
 explains why in a Reregistration Eligibility Decision (RED) document. This
 fact sheet summarizes the information in the RED document for
 reregistration case 0382, Ethephon.

     Ethephon is a plant growth regulator used to promote fruit ripening,
 abscission, flower induction, and other responses. Ethephon is registered
 for use on a number of food, feed and nonfood crops, greenhouse nursery
 stock, and outdoor residential ornamental plants, but is used primarily on
 cotton. Formulations include formulation intermediates and soluble
 concentrates/liquids. Ethephon is applied to plant foliage by either ground
 or aerial equipment.  It also may be applied by hand sprayer to certain home
 garden vegetables and ornamentals.
     Use practice limitations include prohibitions against applying ethephon
 through any type of irrigation system; feeding or grazing livestock in treated
 areas; and treating within 2 to 60 days of harvest, depending on the crop.

     Ethephon was discovered in 1965, and was first registered as a
pesticide in the U.S.  in 1973. EPA issued a Registration Standard for
ethephon in September 1988 (PB89-109427), requiring toxicology, residue
chemistry, and environmental fate and effects data.
-------
Human Health   Toxicity
  Assessment        Ethephon is corrosive in acute dermal irritation studies using rabbits,
                     has the potential to cause eye irritation, and has been placed in Toxicity
                     Category I (the highest of four categories) for these effects. It is moderately
                     acutely toxic by the oral, dermal and inhalation routes (Toxicity  Category
                     IE), and does not cause skin sensitization.
                          An organophosphate pesticide, ethephon caused plasma cholinesterase
                     inhibition in a 16-day oral human study and clinical signs of toxicity in a
                     second study. In a dermal toxicity study using rabbits, skin effects were
                     observed at all doses.
                          In a combined chronic/oncogenicity study using rats, plasma and
                     erythrocyte cholinesterase were inhibited  at all doses.  At the highest dose
                     levels, ethephon caused body weight decrease and kidney effects, but no
                     carcinogenic effects were observed.  In a cancer study using mice, no
                     evidence of treatment related tumors was  observed.  Ethephon has been
                     classified as a Group D carcinogen based on "the insufficiency of the weight
                     of evidence" regarding its cancer-causing potential.
                          One chronic toxicity study using beagle dogs caused plasma
                     cholinesterase inhibition at all doses, and smooth muscle atrophy in the gut.
                     In a second beagle dog study, treatment related effects included decreased
                     spleen and body weight plus decreased hemoglobin and hematocrit in the
                     males.
                           Developmental toxicity studies using rats and rabbits show no
                     evidence of a potential for developmental effects at doses  that are not toxic
                     to the mother.  In a reproductive toxicity study using rats, administration of
                     the test compound caused decreased survival in the offspring and decreased
                     body weight gain in adult females, but no effects on fertility,  gestation,
                     mating, organ weights, or histopathology in any generation.
                          Ethephon was positive in one mutagenicity study and negative in two
                     others. It does not appear to cause delayed neurotoxicity based on a study
                     using hens, however studies using mammals are now required as
                     confirmatory data.
                          Human poisoning incidents involving ethephon include four cases of
                     skin injury (irritation) in California as a result of exposure to field residues,
                     one possible systemic poisoning case, and 29 telephone calls to the National
                     Pesticides Telecommunications Network reporting eye and skin irritation
                     from misuse of ethephon,  sometimes in combination with other pesticides.
                     Dietary Exposure
                          People may be exposed to residues of ethephon through the diet.
                     Tolerances or maximum residue limits have been established for ethephon in
                     many raw agricultural commodities, processed foods, and feed.  Please see
                     40 CFR 180.300(a) and (b), 185.2700(a), (b) and (c),  and 186.2700(a).
-------
Several additional tolerances, including food and feed additive tolerances,
have been proposed.
      Sufficient data are available to assess the adequacy of most established
ethephon tolerances, although some require additional residue chemistry or
animal feeding studies.  Some changes are needed; certain tolerances must
be revoked because registrations for these crop uses no longer exist, and a
tolerance for cottonseed must be increased. Several new tolerances may
need to be established.
      EPA has assessed the chronic dietary risk posed by ethephon,
evaluating exposure and risk, first,  from all uses for which  tolerances exist,
have been recommended or have been proposed and, second,  excluding uses
for which revocation is recommended.  For the overall U.S. population and
22 subgroups, the Anticipated Residue Contribution (ARC) from all current
and proposed ethephon tolerances represents 9% of the Reference Dose
(RfD), an amount believed not to cause adverse effects if consumed daily
over a 70-year lifetime.  The ARC of the most highly exposed subgroup,
non-nursing infants less than one year old, represents 49% of the RfD.
Excluding the tolerances recommended for revocation,  the ARC for the
overall U.S. population represents 8.6% of the RfD, while  the ARC for
non-nursing infants represents 47% of the RfD.  Therefore, it appears that
chronic dietary risk is not of concern.
      Because ethephon causes neurotoxic effects (cholinesterase inhibition),
an acute dietary exposure analysis also was conducted.  Margins of
Exposure (MOEs), which show how closely estimated exposure comes to a
dose of concern, were calculated for several population subgroups. Infants
less than one year old are the only subgroup whose exposure may be of
concern, with 5% of the population estimated to have MOEs of less than 7
(an MOE of 10 or greater is desirable).  However, these risk values
represent an unrealistic worst case situation.  Many conservative
assumptions were included in calculating these risks, such as: all registered
food crops are treated; maximum residue levels are present  on all foods; and
no dilution or degradation of residues has occurred during preparation or
processing of food.  EPA believes it is unlikely that infants and children will
be exposed to ethephon-treated commodities at levels that will result in acute
dietary risk.
      Several international Codex Maximum Residue Limits (MRLs) have
been established for ethephon. Compatibility between U.S. tolerances and
Codex MRLs exists for apples, blackberries, cherries, pineapples and
walnuts, and may be achieved for tomatoes by raising the U.S. tolerance.
For other crops, the U.S. tolerances are being revoked or additional field
residue data are needed.
-------
                     Occupational and Residential Exposure
                          Based on current use patterns, workers may be exposed to ethephon in
                     agricultural and other settings, during and after applications using open
                     pouring methods and broadcast (aerial and ground) treatment or hand-held
                     spray equipment.  Ethephon does not pose risks of systemic dermal or
                     inhalation toxicity.  However, since it does pose risks of severe skin and eye
                     irritation (Toxicity Category I), certain Worker Protection Standard (WPS)
                     provisions apply.
                          To protect post-application workers, a 48-hour restricted entry interval
                     (REI) imposed by the WPS is being retained.  This interval must be
                     increased to 72 hours when ethephon is applied outdoors in arid areas.
                     Certain personal protective equipment (PPE), including protective eyewear,
                     is required for early entry into treated areas.  In addition, since ethephon is
                     in Toxicity Category I for primary skin irritation, "double notification" is
                     required: agricultural workers must be warned orally of its application,  and
                     WPS warning signs  must be posted at entrances to treated areas.
                     Human Risk Assessment
                          Ethephon has the potential to cause severe skin and eye irritation
                     (Toxicity Category I), but otherwise is moderately acutely toxic.  An
                     organophosphate pesticide, it has the potential to cause cholinesterase
                     inhibition.  Ethephon is classified as a "Group D" carcinogen because there
                     is insufficient weight of evidence regarding its cancer-causing potential.
                          Ethephon is used on many food and feed crops. Its tolerances have
                     been reassessed, and while they generally are acceptable, some changes are
                     required. EPA's dietary risk assessments indicate that infants less than one
                     year old encounter the greatest exposure and risk as a result of ethephon
                     crop use. However, since the Agency used many conservative assumptions
                     in calculating these risks, actual dietary exposure and risk to infants as well
                     as the overall U.S. population are believed to be minimal.
                          Pesticide handlers may be exposed to ethephon during application, and
                     post-application workers may be exposed to residues on treated crops.  To
                     reduce workers' skin and eye irritation risks, a 48-hour REI is being
                     retained and is increased to 72 hours in arid areas, use of certain PPE
                     including protective eyewear is required for early entry, and double
                     notification of workers is required.

Environmental   Environmental Fate
   Assessment        Ethephon is not persistent in the environment. The major routes of
                     dissipation appear to be chemical hydrolysis and microbial degradation.
                     Although ethephon degrades in somewhat acidic soils (pH 6.1), it does not
                     hydrolyze in sterile, acidic water (pH 5).  The major degradates are
                     ethylene gas and 2-hydroxy ethyl phosphonic acid.  Ethephon has moderate
                     to low mobility in soil.  It has a very low octanol/water partition coefficient
                     and, therefore, is not expected to accumulate in fish.
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                            In the field, ethephon exhibits the same characteristics of rapid
                       degradation and moderate to low mobility as seen in the laboratory, At field
                       sites in southern California, North Carolina, and Washington, ethephon
                       dissipated with half-lives of about 7 to 25 days.
                       Ecological Effects
                            In dietary studies using the bobwhite quail and mallard duck, ethephon
                       is practically nontoxic to slightly toxic on an acute basis, and practically
                       nontoxic on a subacute basis. Acute oral studies using rats show that
                       ethephon is slightly toxic to mammals.  Other acute toxicity studies show
                       that ethephon is practically nontoxic to coldwater fish, and practically
                       nontoxic to slightly toxic to warmwater fish and freshwater invertebrates.
                       Ethephon is practically nontoxic to shrimp, and slightly toxic to
                       estuarine/marine mollusks. It is relatively nontoxic to honeybees.
                       Regarding effects on terrestrial plants, ethephon reduces plant growth,
                       resulting in reduced shoot lengths and weights.
                       Ecological Effects Risk Assessment
                            Ethephon is expected to have minimal effects on birds and mammals,
                       as well as on fish, freshwater invertebrates, and marine and estuarine
                       organisms.
                            Although minimal effects to aquatic and terrestrial plants (dry land)
                       are expected, ethephon may pose a risk to semi-aquatic/wetland plants
                       (including endangered semi-aquatic plants) when it is used on apples in
                       North Carolina, cotton, tobacco, macadamia nuts, blackberries and
                       pineapple. However,  ethephon is a growth regulator and as such is not
                       intended to be toxic to plants.  Also, the magnitude of this risk is not high.
                       Therefore, while the potential for risk to semi-aquatic plants exists, it is not
                       extensive, arises only  infrequently during periods of high exposure, and is
                       geographically limited.
                            In response to Agency concerns about ethephon's risk to semi-aquatic
                       plants, the registrant proposed as a risk mitigation measure to reduce the
                       maximum use rate for blackberries and apples in North Carolina to 2.0
                       pounds per acre.  They also provided information  indicating that ethephon is
                       used only occasionally at maximum rates when certain weather conditions
                       exist, such as cool temperatures. Considering these factors, EPA believes
                       that the risk to nontarget plants from use of ethephon will be limited.

Additional Data        EPA is requiring the following additional generic data for ethephon to
        Required   confirm its regulatory assessments and conclusions:  Product chemistry;
                       Animal metabolism (poultry); Residue analytical method in plants and
                       animals; Storage stability; Magnitude of the residue in plants (peppers,
                       cantaloupes, grapes, wheat forage and hay, and cotton gin byproducts);
                       Magnitude of the residue in processed sugarcane; Magnitude of the residue
                       in poultry and ruminant; Batch equilibrium on the degradate of 2-hydroxy
                       ethyl phosphonic  acid; Acute and subchronic neurotoxicity.
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                             The Agency also is requiring product-specific data including product
                        chemistry and acute toxicity studies, revised Confidential Statements of
                        Formula (CSFs) and revised labeling for reregistration.

P rod U Ct La be I i n g        All ethephon end-use products must comply with EPA1 s current
          Changes   pesticide product labeling requirements, and with the following:
          Required   Worker Protection
                        Personal Protective Equipment (PPE) for Handlers
                             PPE for handlers will be based on the toxicity of each end-use product
                        (see PR Notice 93-7).  If PPE is necessary for homeowner uses, it will be
                        established during end-use product reregistration.
                        Entry Restrictions for Occupational-Use Products:
                             Worker Protection Standard (WPS) Uses
                             EPA is establishing a 48-hour restricted entry interval (REI), which
                        increases to 72 hours in outdoor areas where average rainfall is less than 25
                        inches a year. PPE for WPS-permitted early entry into treated areas is
                        coveralls over long-sleeved shin and long pants, chemical-resistant gloves
                        such as any waterproof gloves, chemical-resistant footwear plus  socks,  and
                        chemical-resistant headgear for overhead exposures. In addition, protective
                        eyewear is required since ethephon is in Toxicity Category I for eye
                        irritation potential.
                             Non-WPS Uses
                             Products with uses outside the scope of the WPS must bear the
                        following statement:
                             "Do not allow people or pets to touch treated plants until the sprays
                             have dried."
                        Entry Restrictions for Homeowner-Use Products
                             Ethephon products with directions for use by homeowners must bear
                        the following statement:
                             "Do not allow people or pets to touch treated plants until the sprays
                             have dried."
                        Other Labeling Requirements
                             Reduce PPE when Engineering Controls are Used
                             "When handlers use closed systems, enclosed cabs, or aircraft in a
                             manner that meets the requirements listed in the WPS [40 CFR
                             170.240(d)(4-6)], the handler PPE requirements may be reduced or
                             modified as specified in the WPS."

                             User Safety Requirements
                             "Follow manufacturer's instructions for cleaning/maintaining PPE.  If
                             no such instructions exist for washables, use detergent and hot water.
                             Keep and wash PPE separately from other laundry."
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      "Discard clothing and other absorbent materials that have been
      drenched or heavily contaminated with this product's concentrate.  Do
      not reuse them."

      User Safety Statements
      "Users should wash hands before eating, drinking, chewing gum,
      using tobacco, or using the toilet."
      "Users should remove clothing immediately if pesticide gets inside."
      "Users should remove PPE immediately after handling this product.
      As soon  as possible, wash thoroughly and change into clean clothing.
      Wash the outside of gloves before removing."
      Application Restrictions
      "Do not  apply this product in a way that will contact workers or other
      persons,  either directly or through drift. Only protected handlers may
      be in the area during application."
      Notification
      "Notify workers of the application by warning them orally and by
      posting warning signs at entrances to treated areas."
Environmental Hazard
      The following precautionary statement is required to address risks to
wetlands:
      "Do not  apply directly to water, or to areas where surface water is
      present,  or to intertidal areas below the mean high water mark."
For residential use  sites (ornamental trees, shrubs, vines and herbaceous
plants), the statement, "Do not apply directly to water"  may be used instead
of the statement above.
Spray Drift
      The following language is required on each product label that can be
      applied aerially:
      "AVOIDING  SPRAY DRIFT AT THE APPLICATION SITE IS
      THE RESPONSIBILITY OF THE APPLICATOR."
      "The interaction of many equipment-and-weather-related factors
      determine the potential  for spray drift.  The applicator is responsible
      for considering all these factors when making decisions."
      "The following drift management requirements must be followed to
      avoid off-target movement from aerial applications to agricultural field
     crops.  These requirements do not apply to forestry applications,
     public health  uses or to applications using dry formulations."
      "1. The  distance of the outer most nozzles on the boom must not
     exceed 3/4 the length of the wingspan or rotor."
      "2. Nozzles must always point backward parallel with the air stream
     and never be pointed downwards more  than 45 degrees."
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"Where states have more stringent regulations, they should be
observed."
"The applicator should be familiar with and take into account the
information covered in the Aerial Drift Reduction Advisory
Information."
The following Aerial Drift Reduction Advisory Information must be
contained in the product labeling:
"[This section is advisory in nature and does not supersede the
mandatory label requirements]."
Information on Droplet Size
"The most effective way to reduce drift potential is to apply large
droplets. The best drift management strategy is to apply the largest
droplets that provide sufficient coverage and control.  Applying larger
droplets reduces drift potential, but will not prevent drift if
applications are made improperly, or under unfavorable environmental
conditions (See Wind, Temperature and Humidity, and Temperature
Inversions)."
Controlling Droplet Size
o     "Volume - Use high flow rate nozzles to apply the highest
     practical spray volume. Nozzles with higher rated flows
     produce larger droplets."
o     "Pressure - Do not exceed the nozzle manufacturer's
     recommended pressures.  For many nozzle types lower pressure
     produces larger droplets.  When higher  flow rates are needed,
     use higher flow rate nozzles instead of increasing pressure."
o     "Number of nozzles - Use the minimum number of nozzles that
     provide uniform coverage."
o     "Nozzle Orientation - Orienting nozzles so that the spray is
     released parallel to the airstream produces larger droplets than
     other orientations and is the recommended practice. Significant
     deflection from horizontal will reduce droplet size and  increase
     drift potential."
o     "Nozzle Type - Use a nozzle type that is designed for the
     intended application. With most nozzle types, narrower spray
     angles produce larger droplets. Consider using low- drift
     nozzles.  Solid stream nozzles oriented  straight back produce the
     largest droplets and the lowest drift."

Boom Length
"For some use patterns, reducing the effective boom length to less
than 3/4 of the wingspan or rotor length may  further reduce drift
without reducing swath width."
Application Height
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 "Applications should not be made at a height greater than 10 feet
 above the top of the target plants unless a greater height is required
 for aircraft safety.  Making applications at the lowest height that is
 safe reduces exposure of droplets to evaporation and wind."
 Swath Adjustment
 "When applications are made with a crosswind, the swath will be
 displaced downwind.  Therefore, on the up and downwind edges of
 the field, the applicator should compensate for this displacement by
 adjusting the path of the aircraft upwind. Swath adjustment distance
 should increase, with increasing drift potential (higher wind, smaller
 drops, etc.)."
 Wind
 "Drift potential is lowest between winds speeds of 2 - 10 mph.
 However, many factors, including droplet size and equipment type
 determine drift potential at any given speed.  Application should be
 avoided below 2 mph due to variable wind direction and high
 inversion potential.  NOTE: Local terrain can influence wind
 patterns.  Every applicator should be familiar with local wind patterns
 and how they affect spray drift."
 Temperature and Humidity
 "When making applications in low relative humidity, set up equipment
 to produce larger droplets to compensate for evaporation. Droplet
 evaporation is  most severe when conditions are both hot and dry."
 Temperature Inversions
 "Applications  should not occur during  a temperature inversion because
 drift potential  is high. Temperature inversions restrict vertical air
 mixing, which causes small suspended droplets to remain in a
 concentrated cloud.  This cloud can move in unpredictable directions
 due to the light variable winds common during inversions.
 Temperature inversions are characterized by increasing temperatures
 with altitude and are common on nights with limited cloud cover and
 light to no wind. They begin  to form as the sun sets and often
 continue into the morning.  Their presence can be indicated by ground
 fog; however, if fog is not present, inversions can also be identified
 by the movement of smoke from a ground source or an aircraft smoke
 generator. Smoke that layers and moves laterally in a concentrated
 cloud (under low wind conditions) indicates an inversion, while
 smoke that moves upward and rapidly dissipates indicates good
 vertical air mixing."
Sensitive Areas
 "The pesticide should only be applied when the potential for drift to
adjacent sensitive areas (e.g. residential areas,  bodies of water, known
habitat for threatened or endangered species, non-target crops) is
minimal (e.g, when wind is blowing away from the sensitive areas)."
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 Regulatory
Conclusion
   For More
Information
Residue Chemistry
     The following label revisions must be added to pertinent end-use
products:
     o  Product labels must be amended to reflect a maximum allowable
     use rate of 2 Ib ai/A/season for application of ethephon to cotton.
     o  Label directions for apples, cranberries, carob, and olives that are
     for ornamental use only must be clearly designated as such.
     o  The 0.33 Ib/gal SC/L label (264-263) must be amended to prohibit
     the harvesting of any treated pumpkins for human or animal
     consumption and must specify that treatments are to be made to
     pumpkins for seed production only.
     °  Labels must be amended to reduce the maximum use rate for
     blackberries and apples in N.C. to 2.0 Ib per acre.
     A table near the end of the RED document identifies the Food/Feed
Use Patterns Subject to Reregistration for Ethephon.  This table lists
currently acceptable use sites, formulations, application rates, methods and
equipment, pre-harvest and reentry intervals,  and use limitations for
ethephon products registered by the basic manufacturer. All ethephon end-
use product labels must be amended to be consistent with the basic producer
labels, as reflected in this table.

     The use of currently registered products containing ethephon in
accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment.  Therefore, all uses of these
products are eligible for reregistration.
     Ethephon products will be reregistered once the required product-
specific data, revised Confidential Statements of Formula, and revised
labeling are received and accepted by EPA.

     EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for ethephon during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register.  To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
     Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224.  They also can be reached on the Internet via
FEDWORLD.GOV, or obtained from EPA's gopher server,
EARTHLEPA.GOV.
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      Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
      Following the comment period, the ethephon RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
      For more information about EPA's pesticide reregistration program,
the ethephon RED, or reregistration of individual products containing
ethephon, please contact the Special Review and Reregistration Division
(7508W), OPP,  US EPA, Washington, DC 20460, telephone
703-308-8000.
      For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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