AEPA
United States Prevention, Pesticides EPA738-R-02-013
Environmental Protection and Toxic Substances November 2002
Agency (7508C)
Reregistration
Eligibility Decision for
Endosulfan
-------
-------
Pesticide
Reregistration
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F-02-012
November 2002
R.E.D. FACTS
Endosulfan
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
before November 1, 1984, 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. To implement provisions of the Food
Quality Protection Act of 1996, EPA considers the special sensitivity of infants
and children to pesticides, as well as aggregate exposure of the public to pesticide
residues from all sources, and the cumulative effects of pesticides and other
compounds with common mechanisms of toxicity. The Agency develops any
mitigation measures or regulatory controls needed to effectively reduce each
pesticide's risks. EPA then reregisters pesticides that meet the safety standard of
the FQPA and can be used without posing unreasonable risks to human health or
the environment.
When a pesticide is eligible for reregistration, EPA explains the basis for its
decision in a Reregistration Eligibility Decision (RED) document. This fact sheet
summarizes the information in the RED document for reregistration case 0014,
endosulfan.
Use Profile
Endosulfan is a broad spectrum contact insecticide and acaricide registered
for use on a wide variety of vegetables, fruits, cereal grains, and cotton, as well as
ornamental shrubs, trees, vines, and ornamentals for use in commercial
agricultural settings. Total average annual use of endosulfan is estimated at
approximately 1.38 million pounds of active ingredient (Ibs. ai), according to
Agency and registrant estimates. Crops with the highest average percent drop
treated are: squash (40%), eggplant (41%), cantaloupe (31%), sweet potato
(31%), broccoli (26%), pears (20%), and pumpkins (20%). Crops with the
highest sales in 2001 include: cotton (14.2%), cantaloupe (13.2%), tomatoes
(12.2%), and potatoes (8.15%).
Endosulfan is formulated as a liquid emulsifiable concentrate (9-34% ai)
and wettable powder (1-50% ai). The wettable powder formulation is frequently
packaged in water soluble bags. Endosulfan can be applied by groundboom
sprayer, fixed-wing aircraft, chemigation (potatoes only), airblast sprayer, rights-
of-way sprayer, low pressure handwand sprayer, high pressure handwand sprayer,
backpack sprayer and dip treatment.
-------
Regulatory
History
Human Health
Assessment
Endosulfan was first registered as a pesticide in the U.S. in 1954 to control
agricultural insect and mite pests on a variety of field, fruit, and vegetable crops.
A Registration Standard dated September 17, 1981, and a Guidance Document
dated April 1982 were issued for endosulfan, which required additional generic
and product-specific data for the manufacturing products of the technical
registrants. Since the Guidance Document was issued, there have been seven
DCIs generated: 10/23/85, 5/19/86, 5/27/86, 1/30/87, 6/19/87, 9/02/92, and
5/10/94 concerning the potential formation of chlorinated dibenzo-p-dioxins and
dibenzofurans in technical endosulfan products. An additional DCI was issued in
October 1994, which primarily concerned residue chemistry data deficiencies.
Further, in 1991, the technical registrants amended labels to incorporate a
300-foot spray drift buffer for aerial applications between treated areas and water
bodies. This setback was adopted in order to address concerns about
contamination of water and risks to aquatic organisms. In 2000, the technical
registrants amended technical product labels to remove all residential use
patterns. Currently, there are 94 endosulfan products registered.
Toxicity
Endosulfan generally has been shown to have high acute oral and
inhalation toxicity as well as slightly toxic dermal toxicity. It is an irritant to the
eyes and is not a dermal sensitizer. Endosulfan is neither mutagenic nor
carcinogenic. Endosulfan primarily affects the nervous system. Toxic effects
observed in animals from acute, subchronic, developmental neurotoxicity, and
chronic/carcinogenic toxicity studies found that endosulfan causes neurotoxic
effects, which are believed to result from over-stimulation of the central nervous
system. Further, there is evidence (effects observed in a submitted chronic oral
toxicity study in rats) that endosulfan acts as an endocrine disrupter. However,
further investigation is necessary to determine the relevance and impact of such
findings on public health.
Dietary Exposure
EPA has assessed dietary risk by estimating exposure to endosulfan
residues from consumption of food and drinking water that can occur over a
single-day (acute) or longer (chronic). Generally, a dietary (food) risk estimate
that is less than 100% of the acute or chronic Population Adjusted Dose does not
exceed the Agency's risk concern. Acute risk estimates from exposures to food,
associated with the use of endosulfan exceed the Agency's level of concern for
some population subgroups. For example, for exposure resulting from
applications of endosulfan, for the most exposed population subgroup, children 1-
6 years old, the percent acute PAD value is 150% at the 99.9th percentile of
exposure from consumption of food alone. The crops that contributed the most to
the risks of concern are succulent beans and peas. Chronic dietary (food)
exposure estimates are below the Agency's level of concern for all
-------
subpopulations. For the most highly exposed subpopulation, children 1-6 years
old, the percent chronic PAD value is 17% from consumption of food alone.
Drinking water exposure to endosulfan can occur through ground and
surface water contamination. EPA used modeled Tier 2 estimates of endosulfan
and endosulfan sulfate to estimate risk for acute exposures. Taking into account
the supported uses of endosulfan, the Agency concluded that residues of
endosulfan in drinking water are of concern. Drinking water estimates for
chronic exposures, based on models, from both ground and surface water are not
of concern.
Risk from All Registered Pesticide Endosulfan Exposures
To assess risks from all endosulfan exposures, the Agency combined risk
from food and drinking water exposure only. The technical registrants are not
supporting residential or other non-occupational uses of endosulfan. As a result,
these use patterns have not been considered for regulatory purposes at this time.
The acute estimated drinking water concentrations for endosulfan are above the
acute drinking water level of comparisons (DWLOCs) for infants <1 year and the
most sensitive population subgroup, children 1-6 years old. The chronic
estimated drinking water concentrations for the U.S. general population and all
population subgroups are below the chronic drinking water levels of comparisons
(DWLOCs) for the U.S. general population and all population subgroups and,
therefore, are not of concern.
Occupational Exposure
Occupational handlers can be exposed to endosulfan through mixing,
loading and/or applying a pesticide or re-entering treated sites. Occupational
handlers of endosulfan include individual farmers or growers who mix, load
and/or apply pesticides and professional or custom agricultural applicators. The
post-application occupational risk assessment considered exposures to workers
entering treated sites in agriculture.
Risk for all of these potentially exposed populations is measured by a
Margin of Exposure (MOE), which determines how close the occupational
exposure comes to a NOAEL. Generally, MOEs greater than 100 are not of
concern. Restricted Entry Intervals (REIs) are 24 hours on current endosulfan
labels. The Agency has determined that there are potential mixer, loader,
applicator as well as post-application exposures to occupational handlers. Based
on current use patterns, there are some short-term dermal and inhalation risks of
concerns for workers who mix, load and apply endosulfan to agricultural sites as
well as to those workers who re-enter a treated area following application of
endosulfan.
Environmental
Assessment
Ecological risks are also of concern to the Agency. The environmental risk
assessment suggests that exposure to endosulfan could result in both acute and
chronic risks of concern for terrestrial and aquatic organisms. Exposure to
-------
Risk Mitigation
Measures
endosulfan has resulted in both reproductive and development effects in
nontarget animals, particularly birds, fish and mammals.
To mitigate human health and ecological risks of concern for endosulfan,
the following measures will be implemented:
Dietary (Food) Risk
• Delete use on succulent beans, succulent peas, spinach, and grapes
Dietary (Drinking Water) and Ecological Risk
Several mitigation measures are needed to reduce the potential for
contamination of drinking water.
• Delete use on pecans;
Reduce maximum seasonal application rates from 31bs./ai/A to 2.5
Ibs./ai/A for pome fruit, stone fruit, and citrus;
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2 Ibs./ai/A
for melons, cucurbits, lettuce, tomatoes, sweet potatoes, cotton (ground),
broccoli, cauliflower, cabbage, kohlrabi, brussels sprouts, strawberries,
filberts, walnuts, almonds, macadamia nuts, peppers, eggplant, potatoes,
carrots, dry beans, dry peas, and tobacco;
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 1.5
Ibs./ai/A for sweet corn, cotton (aerial) and blueberries;
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 1 Ib./ai/A
for celery;
Require 100 ft. spray buffer for ground applications between a treated area
and water bodies;
Require 30 ft. maintained vegetative buffer strip between a treated area and
water bodies;
Require all products to be Restricted Use;
Restrict use on cotton to AZ, CA, NM, OK and TX only; and
Restrict use on tobacco to IN, KY, OH, PA, TN and WV only.
Occupational Risk
• Require all wettable powers to be packaged in water soluble bags;
• Cancel use of wettable powders on tomatoes, sweet corn, sweet potatoes,
cotton, small grains, alfalfa (seed), carrots, dry beans, dry peas, pineapples,
and tobacco;
• Cancel aerial application using the wettable powder formulation on pome
fruits, stone fruits, citrus, blueberries, strawberries, collard greens (seed),
kale (seed), mustard greens (seed), radish (seed), turnip (seed), rutabaga
-------
(seed), broccoli, (seed), cauliflower (seed), kohlrabi (seed), cabbage (seed),
filberts, walnuts, almonds, and macadamia nuts;
Require closed mixing/loading systems for aerial application using the EC
formulation on pome fruits, stone fruits, citrus, sweet corn, sweet potatoes,
cotton, collard greens (seed), kale (seed), mustard greens (seed), radish
(seed), turnip (seed), rutabaga (seed), broccoli, (seed), cauliflower (seed),
kohlrabi (seed), cabbage (seed), blueberries, small grains, alfalfa (seed),
filberts, walnuts, almonds and macadamia nuts;
Require closed cabs for airblast applications on pome fruits, stone fruits,
citrus, filberts, walnuts, almonds and macadamia nuts;
Prohibit use of high pressure handwands with rates greater than 0.005
Ibs/ai/gal;
Increase REI to 48 hours for all crops except as noted in the following
bullets;
Increase REI for WP products to 3 days for melons and cucurbits;
• Increase REI for WP products to 4 days for lettuce, celery, pome fruit,
stone fruit, citrus, collard greens, kale, mustard greens, radish, turnip,
rutabaga, ornamental trees and shrubs;
Increase REI for WP products to 5 days for collard greens (seed), kale
(seed), mustard greens (seed), radish (seed), turnip (seed) and rutabaga
(seed);
Increase REI for WP products to 9 days for blueberries, broccoli,
cauliflower, kohlrabi, cabbage, and brussels sprouts;
Increase REI for WP products to 12 days for broccoli (seed), cauliflower
(seed), kohlrabi (seed), and cabbage (seed);
Increase REI for EC products to 3 days for sweet potatoes
Increase REI for EC products to 4 days for broccoli, cauliflower, kohlrabi,
cabbage, and brussels sprouts;
Increase REI for EC products to 6 days for blueberries;
• Increase REI for EC products to 7 days for broccoli (seed), kohlrabi (seed),
and cabbage (seed); and
• Increase REI for EC products to 17 days for sweet corn.
Stakeholder Given the toxicity and persistence of endosulfan and potential risks to
Process aquatic organisms, the Agency has developed a number of mitigation measures
in order to reduce the risks to aquatic organisms outlined in this document.
While the Agency believes that these measures will reduce the potential for
exposures to aquatic organisms and reduce the overall environmental loading of
endosulfan, it also believes that in specific geographic areas where conditions
exist that make aquatic organisms especially vulnerable (e.g., shallow, leaky
aquifers, highly erodible lands, the presence of especially sensitive organisms and
-------
Additional Data
Required
high use of endosulfan) additional measures may be identified. In order to more
fully evaluate the risks in these vulnerable areas; the risk management strategies
that may be in place or could potentially be implemented in such areas (e.g., use
of retention ponds) to reduce exposure; and the benefits of the use of endosulfan
in those areas, the Agency is planning to conduct a stakeholder process to
accomplish this objective. Further, the impacts of atmospheric transport may
require additional evaluation during this time period.
Additional mitigation measures may be needed following the completion of this
process.
EPA is requiring the following additional generic studies for endosulfan to
confirm its regulatory assessments and conclusions:
OPPTS 850.2100: Avian acute oral toxicity of bobwhite quail and mallard
ducks
• OPPTS 850.2200: Avian subchronic oral toxicity of bobwhite quail and
mallard ducks
OPPTS 850.2300: Avian reproduction study
• OPPTS 850.1075: Freshwater fish acute toxicity study of bluegill sunfish
OPPTS 850.1300: Early life stage fish
OPPTS 850.1350: Life cycle invertebrate
• OPPTS 850.1500: Freshwater fish full life cycle using rainbow trout
• OPPTS 850.1075: Estuarine/marine fish acute toxicity study
• OPPTS 850.1035: Estuarine/marine invertebrate acute toxicity study of
• mysid shrimp
• OPPTS 850.1735: Whole sediment acute toxicity testing using a
freshwater invertebrate
• OPPTS 850.1740: Whole sediment acute toxicity testing using a
estuarine/marine invertebrate
• OPPTS 850.1735S: Whole sediment chronic toxicity testing using a
freshwater invertebrate
• OPPTS 850.1740S: Whole sediment chronic toxicity testing using an
estuarine/marine invertebrate
164-2 (Special Study): Vegetative buffer effectiveness study
OPPTS 835.7100: Groundwater monitoring study
• OPPTS 835.7200: Surface drinking water monitoring study
OPPTS 870.6200: Subchronic Neurotoxicity - Rat
OPPTS 870.6300: Developmental Neurotoxicity Toxicity Study - Rat
OPPTS 860.1380: Storage stability (oils seed, non-oily grain and
processed commodities)
-------
OPPTS 860.1500: Crop field trials for the following raw agricultural
commodities: barley hay, and pearled barley; oat forage, hay, and rolled
oats; rye forage; wheat forage, and hay
OPPTS 860.1500: Crop field trials for tobacco and a pyrolysis
OPPTS 860.1520: Magnitude of residue in processed food/feed
commodities
OPPTS 875.1100: Dermal outdoor exposure for applying dip treatments to
trees and roots or whole plants
OPPTS 875.1700: Product use information for applying dip treatments to
trees and roots or whole plants
Regulatory
Conclusion
For More
Information
The Agency is also requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of Formula
(CSFs), and revised labeling for reregistration.
The Agency has assessed all 80 tolerances for endosulfan and can make a
FQPA safety determination based on a review of the dietary (food and drinking
water), ecological and occupational risks associated with the supported uses of
currently registered pesticides containing endosulfan.
Agricultural uses of endosulfan based on approved labeling pose
occupational risks of concern and ecological risks that constitute unreasonable
adverse effects on the environment. However, the Agency believes these risks
can likely be mitigated to levels below concern through changes to pesticide
labeling and formulations. Accordingly, the Agency has determined that
endosulfan is eligible for reregistration provided that: (1) additional required data
will confirm this decision for occupational exposures associated with the
application of dip treatment to roots or whole plants and ecological risks; and (2)
the risk mitigation outlined in the RED are adopted, and label amendments are
made to reflect these measures. Further, if vulnerable areas in specific
geographic areas are identified as a result of the stakeholder process, additional
ecological risk mitigation measures may be necessary to protect especially
sensitive organisms. The endosulfan RED document includes guidance and time
frames for complying with any label changes for products containing endosulfan.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for endosulfan 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 Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460; telephone number 703-305-
5805.
Electronic copies of the RED, this Fact Sheet, and all supporting
documents are available on the Internet. See http://www.epa.gov/REDs.
-------
The Agency has also established an official record for this action under docket
control numbers OPP-34242 and eDocket OPP-2002-0262.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Service Center for Environmental Publications (EPA/NSCEP), PO Box
42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198; fax 513-489-
8695.
Following the comment period, the endosulfan RED document also will be
available from the National Technical Information Service (NTIS), 5285 Port
Royal Road, Springfield, VA 22161, telephone 1-800-553-6847, or 703-605-
6000.
For more information about EPA's pesticide reregistration program, the
endosulfan RED, or reregistration of individual products containing endosulfan
please contact the Special Review and Reregistration Division (7508C), 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 Pesticide Information Center (NPIC). Call toll-free 1-800-858-7378,
from 6:30 am to 4:30 pm Pacific Time, or 9:30 am to 7:30 pm Eastern Standard
Time, seven days a week. Their internet address is http://npic.orst.edu.
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
July 3 1,2002
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the U.S. Environmental Protection Agency (hereafter referred to
as EPA or the "Agency") has completed its review of the available data and public comments
received related to the risk assessments for the chlorinated cyclodiene pesticide endosulfan. The
public comment period on the preliminary risk assessment phase of the reregi strati on process
commenced on September 13, 2001 and closed on November 13, 2001. The Agency has revised
the human health and environmental effects risk assessments based on the comments received
during the public comment period and additional data received from the registrant.
Based on its review, the Agency has identified risk mitigation measures that it believes are
necessary to address the human health and ecological risks associated with the current uses of
endosulfan. The Agency believes that these risk mitigation measures will adequately address
human health and ecological risks for endosulfan. However, further mitigation measures for
ecological risk may be warranted following the completion of the stakeholder process outlined in
this document. The Agency has identified several mitigation measures to address ecological
risks. While the Agency believes that these measures will reduce the potential for exposures to
aquatic organisms and reduce the overall environmental loading of endosulfan, it also believes
that in specific geographical areas where conditions exist that make aquatic organisms especially
vulnerable additional measures may be identified. Further, the Agency is unable to fully
evaluate the ecological risks associated with the atmospheric transport of endosulfan at this time.
In order to more fully evaluate the risks in these vulnerable areas; the risk management strategies
that may be in place or could potentially be implemented in such areas to reduce exposure; and
the benefits of the use of endosulfan in those areas, the Agency is planning to conduct a public
comment and stakeholder process.
EPA is now publishing its reregi strati on eligibility, risk management, and tolerance
reassessment decisions for the current uses of endosulfan, and its associated human health risks
which address risks from dietary exposure to food and water and occupational exposures. As
mentioned above, the Agency will conduct a stakeholder process to address environmental risks
in especially vulnerable areas at the completion of which the Agency may identify additional
mitigation measures that may be needed. The enclosed "Reregi strati on Eligibility Decision for
Endosulfan," which was approved on July 31, 2002, contains the Agency's decision on the
individual chemical endosulfan.
-------
A Notice of Availability for the Reregi strati on Eligibility Decision (RED) for Endosulfan is
being published in the Federal Register. To obtain a copy of the RED document, please contact
the OPP Public Regulatory Docket (7502C), US EPA, Ariel Rios Building, 1200 Pennsylvania
Avenue NW, Washington, DC 20460, telephone (703) 305-5805. Electronic copies of the RED
and all supporting documents are available on the Internet. See
http://www.epa.sov/pesticides/reresistration/status.htm.
As part of the Agency's effort to involve the public in the implementation of the Food
Quality Protection Act of 1996 (FQPA), the Agency is undertaking a special effort to maintain
open public dockets and to engage the public in the reregi strati on and tolerance reassessment
processes. In cooperation with the U.S. Department of Agriculture, the Agency held a
teleconference on July 29, 2002, during which the results of the human health and environmental
effects risk assessments were presented to interested stakeholders. Information discussed during
the call, such as endosulfan usage and occupational practices, are reflected in this RED. Also, a
close-out conference call was conducted on July 30, 2002 with many of the same participants
from the July 29 conference call to discuss the risk management decisions and resultant changes
to the endosulfan labels.
A risk mitigation proposal for endosulfan was submitted by the Endosulfan Task Force
(ETF), the technical registrant. During the public comment period provided for the preliminary
risk assessment, EPA also received comments from the Natural Resources Defense Council,
World Wildlife Fund, Pesticide Action Network Asia and the Pacific, Boulder Regional Group,
American Society of Consulting Arborists, Gaia Foundation, Rural Action Safe Pest Control
Program, and private citizens.
Please note that the endosulfan risk assessment and the attached RED concern only this
particular pesticide. The Food Quality Protection Act (FQPA) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency consider "available information"
concerning the cumulative effects of a particular pesticide's residues and other substances that
have a common mechanism of toxicity with other pesticides. The Agency does not currently
have data available to determine with certainty whether endosulfan or endosulfan sulfate have a
common mechanism of toxicity with any other substances. For the purposes of this decision, the
Agency has assumed that there are not any other chemical substances that share a common
mechanism of toxicity with endosulfan and has not performed a cumulative risk assessment as
part of this reregi strati on review of endosulfan. If the Agency identifies other substances that
share a common mechanism of toxicity with endosulfan, then the cumulative risks of these
chemicals will be considered.
As mentioned above, the Agency has identified risk mitigation measures that it believes are
necessary to address the human health risks associated with the current uses of endosulfan and
measures to reduce the potential for exposures to aquatic organisms and reduce the overall
environmental loading of endosulfan. Accordingly, the Agency recommends that registrants
implement these risk mitigation measures on an accelerated schedule. Sections IV and V of this
RED describe labeling amendments for end-use products and data requirements necessary to
implement these mitigation measures. Instructions for registrants for submitting the revised
labeling can be found in the set of instructions for product-specific data that accompanies this
RED.
-------
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by endosulfan.
Where the Agency has identified any unreasonable adverse effect to human health and the
environment, the Agency may at any time initiate appropriate regulatory action to address this
concern.
There will be a 60-day public comment period for this document, commencing on the day
the Notice of Availability publishes in the Federal Register. In addition to the public comment
period the Agency will initiate a stakeholder process, which will be initiated in the near future to
address potentially vulnerable areas.
This document contains a generic and/or a product-specific Data Call-In(s) (DCI) that
outline(s) further data requirements for this chemical. Note that a complete DCI, with all the
pertinent instructions, is being sent to registrants under separate cover. Additionally, for
product-specific DCIs, the first set of required responses is due 90 days from the receipt of the
DCI letter. The second set of required responses is due eight months from the date of the DCI.
If you have questions on this document or the proposed label changes, please contact the
Special Review and Reregi strati on Division representative, Stacey Milan at (703) 305-2505. For
questions about product reregi strati on and/or the Product DCI that accompanies this document,
please contact Karen Jones at (703) 308-8047.
Sincerely,
Lois A. Rossi, Director
Special Review and
Reregi strati on Division
Attachment
-------
Reregistration Eligibility Decision
for
Endosulfan
Case No. 0014
-------
TABLE OF CONTENTS
Endosulfan Team i
Glossary of Terms and Abbreviations n
Executive Summary v
I. Introduction 1
II. Chemical Overview 2
A. Regulatory History 2
B. Chemical Identification 2
C. Use Profile 3
D. Estimated Usage of Pesticide 6
III. Summary of Endosulfan Risk Assessments 8
A. Human Health Risk Assessment 9
1. Dietary Risk from Food 9
a. Toxicity 9
b. FQPA Safety Factor 10
c. Population Adjusted Dose (PAD) 11
d. Exposure Assumptions 11
e. Food Risk Characterization 12
2. Dietary Risk from Drinking Water 13
a. Surface Water 13
b. Ground Water 14
c. Drinking Water Levels of Comparison (DWLOC) 14
3. Aggregate Risk 15
4. Occupational Risk 16
a. Toxicity 16
b. Occupational Exposure 17
c. Occupational Handler Risk Summary 18
(1) Agricultural Handler Risk 19
(2) Post-Application Occupational Risk 22
(3) Human Health Incident Data 25
B. Environmental Risk Assessment 25
1. Environmental Fate and Transport 25
2. Risk to Birds and Mammals 27
a. Toxicity (Hazard) Assessment 27
3. Exposure and Risk 28
4. Risk to Aquatic Species 29
a. Toxicity (Hazard) Assessment 29
b. Exposure and Risk 30
5. Probabilistic Assessment 32
-------
6. Risks to Endangered Species 33
7. Ecological Incident Reports 34
8. Endocrine Disruption 34
9. Long Range Transport 35
IV. Risk Management and Reregistration Decision 35
A. Determination of Reregistration Eligibility 35
B. Phase 3 Comments and Responses 36
C. Regulatory Position 37
1. FQPA Assessment 37
a. "Risk Cup" Determination 37
b. Tolerance Summary 37
2. Endocrine Disrupter Effects 48
3. Labels 49
a. Agricultural Use Exposure Reduction Measures 49
D. Regulatory Rationale 51
1. Human Health Risk Mitigation 51
a. Dietary (food) 51
b. Drinking Water 51
c. Aggregate Risk Mitigation 53
d. Occupational Risk Mitigation 54
(1) Agricultural Handler Risk Mitigation 54
2. Environmental Risk Mitigation 72
3. Public Comment and Stakeholder Process to Address Aquatic Risks and
Long Range Transport 73
E. Other Labeling 74
1. Endangered Species Statement 74
2. Spray Drift Management 75
V. What Registrants Need to Do 77
A. Data Call-In Responses 78
B. Manufacturing Use Products 79
1. Additional Generic Data Requirements 79
2. Labeling for Manufacturing Use Products 80
C. End-Use Products 80
1. Additional Product-Specific Data Requirements 80
2. Labeling for End-Use Products 81
D. Existing Stocks 81
E. Labeling Changes Summary Table 81
VI. APPENDICES 92
Appendix A. Endosulfan Table of Use Patterns Reflecting Label Changes Based
on Mitigation Measures 93
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 136
-------
Appendix C. Technical Support Documents 145
Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography) 148
Appendix E. Generic Data Call-In 214
Appendix F. Product Specific Data Call-In 215
Appendix G. EPA'S Batching of Endosulfan Products for Meeting Acute Toxicity
Data Requirements for Reregistration 216
Appendix H. List of Registrants Sent this Data Call-In Notice 219
Appendix I. List of Available Related Documents and Electronically Available
Forms 220
-------
ENDOSULFAN TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Ruth Allen
Ken Dockter
Robert Fricke
Sherrie Kinard
Diana Locke
Elizabeth Mendez
John Punzi
Renee Sandvig
Environmental Fate Risk Assessment
Faruque Khan
Richard Lee
Jose Melendez
Rodolfo Pisigan
Thomas Steeger
Nelson Thurman
Dirk Young
Use and Usage Analysis
Jonathan Becker
Angel Chiri
Colwell Cook
David Donaldson
Bill Gross
Nikhil Mallampalli
Nicole Mosz
T. J. Wyatt
Istanbul Yusuf
Registration Support
Dana Pilitt
Risk Management
Stacey Milan
Mark Hartman
Phil Budig
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
AGDCI Agricultural Data call-in
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
ARC Anticipated Residue Contribution
BCF Bioconcentration Factor
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CFR Code of Federal Regulations
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
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, noncarcinogenic health effects are not
anticipated
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
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
FAO Food and Agriculture Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLC Gas Liquid Chromatography
GLN Guideline Number
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.
HAFT Highest Average Field Trial
HOT Highest Dose Tested
IR Index Reservoir
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, airorfeed, e.g., mg/1, mg/kgorppm.
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.
11
-------
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse 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/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
NA Not Applicable
N/A Not Applicable
NAWQA USGS National Water Quality Assessment
NOEC No Observable Effect Concentration
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
NPDES National Pollutant Discharge Elimination System
NR Not Required
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
Pa Pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PAD Population Adjusted Dose
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAI Purified Active Ingredient
PAM Pesticide Analytical Method
PCA Percent Crop Area
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
PRZM/
EXAMS Tier II Surface Water Computer Model
Q! * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RAC Raw Agriculture Commodity
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
RS Registration Standard
RUP Restricted Use Pesticide
SAP Science Advisory Panel
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SLC Single Layer Clothing
ill
-------
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
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
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
TRR Total Radioactive Residue
UF Uncertainty Factor
ug/g Micrograms Per Gram
ug/L Micrograms Per Liter
USDA United States Department of Agriculture
SGS United States Geological Survey
UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
-------
Executive Summary
EPA has completed its review of public comments concerning the preliminary risk
assessments and is issuing its risk management decision for endosulfan. The revised risk
assessments are based on review of the required target data base supporting the use patterns of
currently registered products and additional information received. The Agency invited
stakeholders to provide proposals, ideas or suggestions on appropriate mitigation measures
before the Agency issued its risk mitigation decision concerning endosulfan. After considering
the risks identified in the revised risk assessment, mitigation measures proposed by the
Endosulfan Task Force, which consists of the technical registrants of endosulfan, and comments
and mitigation suggestions from other interested parties, the Agency developed its risk
management decision for uses of endosulfan that pose risks of concern. This decision is
discussed fully in this document.
Endosulfan, a dioxathiepin (broadly classified as an organochlorine), is a broad spectrum
contact insecticide and acaricide that is used on a wide variety of vegetables, fruits, cereals, and
cotton, as well as ornamental shrubs, trees, vines, and ornamental herbaceous plants in
commercial agricultural settings. Technical grade endosulfan is composed of two
stereochemical isomers: a-endosulfan and p-endosulfan, in concentrations of approximately
70% and 30%, respectively. Endosulfan was first registered in 1954 to control a broad spectrum
of agricultural insect and mite pests on various crops. Use data from 1987 to 1997 indicate an
average domestic use of approximately 1.38 million pounds of active ingredient per year.
The Food Quality Protection Act of 1996 (FQPA) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency consider "available information"
concerning the cumulative effects of a particular pesticide's residues and other substances that
have a common mechanism of toxicity with other pesticides. The Agency does not currently
have data available to determine with certainty whether endosulfan or endosulfan sulfate have a
common mechanism of toxicity with any other substances. For the purposes of this decision, the
Agency has assumed that there are not any other chemical substances that share a common
mechanism of toxicity with endosulfan and has not performed a cumulative risk assessment as
part of this reregi strati on review of endosulfan. If the Agency identifies other substances that
share a common mechanism of toxicity with endosulfan, then the cumulative risks of these
chemicals will be considered once the final framework the Agency will use for evaluating
cumulative risks is available.
Overall Risk Summary
The Agency's human health risk and ecological risk assessments for endosulfan indicate
risks of concern. Acute dietary (food) risk exceeds the Agency's level of concern (>100%
aPAD) at the 99.9th exposure percentile for children 1-6 years of age (150% aPAD). Significant
contributors to acute exposure have been identified as succulent beans and succulent peas. The
dietary (food) assessment also concludes that for all commodities, the chronic risk estimates are
below the Agency's level of concern (<100% cPAD) for the U.S. population (<1% of the cPAD)
-------
and all population subgroups with the highest exposed population subgroup, children 1-6 years
of age occupying 17% of the cPAD.
Dietary (drinking water) risk for acute exposures, based on models, from both ground and
surface water are of concern. Drinking water estimates for chronic exposures, based on models,
from both ground and surface water are not of concern. Further, there are some concerns for
workers who mix, load and apply endosulfan to agricultural sites as well as to those workers who
re-enter a treated area following application of endosulfan.
For ecological effects, the Agency has conducted a screening level assessment for
terrestrial impacts and a refined exposure assessment for aquatic impacts of endosulfan use.
These assessments indicate that endosulfan is likely to result in acute and chronic risk to both
terrestrial and aquatic organisms.
To mitigate risks of concern posed by the uses of endosulfan, the Agency considered the
mitigation proposal submitted by the technical registrants, as well as comments and mitigation
ideas from other interested parties, and has decided on a number of label amendments to address
the dietary (food and drinking water), worker and ecological concerns. Results of the risk
assessments, and the necessary label amendments to mitigate those risks, are presented in this
RED.
Dietary Risk
Acute risk estimates for food and drinking water exceed the Agency's level of concern;
therefore, mitigation measures are warranted at this time for dietary exposure to endosulfan. To
mitigate the risks from acute food exposure, the following crop uses will be canceled: succulent
beans, succulent peas, grapes, and spinach.
Several mitigation measures are needed to reduce the potential for the contamination of
drinking water. These include a 100-foot setback for ground applications between treated areas
and water bodies, a 30-foot vegetative buffer between treated areas and water bodies, reductions
in maximum application rates, reductions in maximum seasonal application rates and reductions
in the maximum number of applications allowed per use season. These measures, together with
conservative assumptions used in the modeled estimates of drinking water exposure, lead the
Agency to believe that risk from drinking water will not exceed its level of concern. Drinking
water monitoring data will be required to confirm this conclusion.
Occupational Risk
Occupational exposure to endosulfan is of concern to the Agency, and it has been
determined that a number of measures are necessary to mitigate these risks. For the agricultural
uses of endosulfan, several mixer/loader/applicator risk scenarios currently exceed the Agency's
level of concern. To mitigate these risks several steps are needed including placing all wettable
powder (WP) products in water soluble bags, the deletion of some uses from WP products,
vi
-------
deletion of aerial application of WP products for some crops, requiring closed mixing/loading
systems for aerial applications of the emulsifiable concentrate (EC) formulation for some uses,
requiring closed cabs for all airblast applications except for ornamental trees/shrubs and
reductions in application rates.
The risks to workers reentering treated fields are of concern for several crops. These
risks can be mitigated provided the restricted entry intervals recommended in this document are
established.
Ecological Risk
Ecological risks are also of concern to the Agency. The environmental risk assessment
suggests that exposure to endosulfan could result in both acute and chronic risks of concern for
terrestrial and aquatic organisms. To reduce these risks, several mitigation measures are needed.
These measures include a 100-foot setback for ground applications between treated areas and
water bodies, a 30-foot vegetative buffer between treated areas and water bodies, reductions in
single maximum application rates, reductions in maximum seasonal application rates, reductions
in maximum numbers of applications allowed in a single growing season and deletion of use on
pecans.
Stakeholder Process to Address Aquatic Risks and Long Range Transport
Given the toxicity and persistence of endosulfan and potential risks to aquatic organisms,
the Agency has developed a number of mitigation measures in order to reduce the risks to
aquatic organisms outlined in this document. While the Agency believes that these measures
will reduce the potential for exposures to aquatic organisms and reduce the overall
environmental loading of endosulfan, it also believes that in specific geographic areas where
conditions exist that make aquatic organisms especially vulnerable (e.g., shallow, leaky aquifers,
highly erodible lands, the presence of especially sensitive organisms and high use of endosulfan)
additional measures may be identified. In order to more fully evaluate the risks in these
vulnerable areas; the risk management strategies that may be in place or could potentially be
implemented in such areas (e.g., use of retention ponds) to reduce exposure; and the benefits of
the use of endosulfan in those areas, the Agency is planning to conduct a public comment and
stakeholder process to accomplish this objective. Further, the impacts of atmospheric transport
may require additional evaluation during this time period. Additional mitigation measures may
be needed following the completion of this process.
Endosulfan is a semivolatile and persistent cyclodiene pesticide that can migrate over a
long distance through various environmental media such as air, water, and sediment. Once
endosulfan is applied to crops, it can either persist in soil as a sorbed phase or be removed
through several physical, chemical, and biological processes. Recent studies suggest that
secondary emissions of residual endosulfan continue to recycle in the global system while they
slowly migrated and are redeposited via wet deposition in the Northern Hemisphere. The
occurrence of endosulfan in remote regions like the Great Lakes, the Arctic, and mountainous
vii
-------
areas is well documented. Endosulfan can also enter the air as adsorbed phase onto suspended
particulate matter, but this process does not appear to be a major contributor to long range
transport like volatilization.
The presence of endosulfan in the remote areas like Arctic and the Great Lakes requires
further understanding of the transport mechanisms from the atmosphere. The potential impact of
atmospheric deposition of endosulfan into surface water and its potential effect on water quality
and aquatic organisms in the non-use areas is not well documented. Despite the progress made
in recent years in estimating the persistence and long-ranged transport of chemicals using
models, a validated global model has not been published because of uncertainties involved in the
source inventories, chemical fate data, degradative pathways and exposure analyses. Future work
will be aimed at developing a comprehensive screening tool that can be used reliably in risk
assessments for regulatory purposes. Part of the stakeholder process will include an evaluation
of to what extent data related to long range transport may be necessary.
Vlll
-------
I. Introduction
The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregi strati on of products with active ingredients registered prior to November
1, 1984. The amended Act calls for the development and submission of data to support the
reregi strati on of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency (referred to as EPA or "the Agency"). Reregi strati on involves
a thorough review of the current scientific database 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" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into
law. This Act amends FIFRA to require tolerance reassessment of all existing tolerances. The
Agency has decided that, for those chemicals that have tolerances and are undergoing
reregi strati on, the tolerance reassessment will be initiated through this reregi strati on process. It
also requires that by 2006, EPA must review all tolerances in effect on the day before the date of
the enactment of the FQPA, which was August 3, 1996.
FQPA also amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a
safety finding in tolerance reassessment based on factors including an assessment of cumulative
effects of chemicals with a common mechanism of toxicity. Endosulfan belongs to a group of
pesticides called organochlorines. Although chemical class is not necessarily equivalent to a
common mechanism of action, in some cases, chemicals within the same class have been shown
to share a common mechanism of action and are being considered together for purposes of a
cumulative assessment (e.g., the organophosphates). Specifically, endosulfan belongs to the
chlorinated cyclodiene (organochlorine) class of insecticide/acaricide. The Agency does not
currently have data available to determine with certainty whether endosulfan or endosulfan
sulfate have a common mechanism of toxicity with any other substances. For the purposes of
this decision, the Agency has assumed that there are not any other chemical substances that share
a common mechanism of toxicity with endosulfan and not performed a cumulative risk
assessment as part of this reregi strati on review of endosulfan. If the Agency identifies other
substances that share a common mechanism of toxicity with endosulfan, then the cumulative
risks of these chemicals will be considered once the final framework the Agency will use for
evaluating cumulative risks is available.
The implementation of FQPA has required the Agency to revisit some of its existing
policies relating to the determination and regulation of dietary risk and has also raised a number
of new issues for which policies need to be created. These issues were refined and developed
through collaboration between the Agency and the Tolerance Reassessment Advisory Committee
(TRAC), which was composed of representatives from industry, environmental groups and other
interested parties.
-------
This document summarizes the Agency's revised human health and ecological risk
assessments, its progress toward tolerance reassessment and the reregi strati on eligibility decision
for endosulfan. This document consists of six sections. Section I contains the regulatory
framework for reregi strati on/tolerance reassessment. Section II provides a profile of the use and
usage of the chemical. Section III gives an overview of the revised human health and
environmental effects risk assessments resulting from public comments and other information.
Section IV presents the Agency's decision on reregi strati on eligibility and risk management
decisions. Section V summarizes the label changes necessary to implement the risk mitigation
measures outlined in Section IV. Section VI provides information on how to access related
documents. Finally, the Appendices list Data Call-In (DCI) information. The revised risk
assessments and related addenda are not included in this document, but are available on the
Agency's web page http://www.epa.sov/pesticides/endosulfan. and in the public docket.
II. Chemical Overview
A. Regulatory History
Endosulfan is a broad spectrum insecticide and acaricide first registered for use in the
United States in 1954 to control agricultural insect and mite pests on a variety of field, fruit, and
vegetable crops. A Registration Standard dated September 17, 1981, and a Guidance Document
dated April 1982 were issued for endosulfan, which required additional generic and product-
specific data for the manufacturing products of the technical registrants. In addition, Data-Call-
ins (DCIs) were issued in June 1987 and September 1992 concerning the potential formation of
chlorinated dibenzo-p-dioxins and dibenzofurans in technical endosulfan products. Since the
Guidance Document was published in April 1992, there have been a total of seven DCIs issued
(10/23/85, 05/19/86, 05/27/86, 01/30/87, 06/19/87, 09/02/92, and 05/10/94). Another DCI was
issued in October 1994, which primarily concerned data residue chemistry deficiencies.
In 1991, the technical registrants amended labels to incorporate a 300-foot spray drift
buffer for aerial applications between treated areas and water bodies. This setback was adopted
in order to address concerns about contamination of water and risks to aquatic organisms. In
2000, the technical registrants amended technical product labels to remove all residential use
patterns. Further, the registrants have agreed to restrict the annual maximum use rate for all uses
to 31bs. active ingredient per acre.
B. Chemical Identification
CK /Cl
Endosulfan:
cr ci
-------
• Common name: Endosulfan
• Chemical name: 6,7,8,9,10,10-hexachloro-l,5,5a,6,9,9a-hexahydro-
6,9-methano-2,4,3-benzodioxathiepin-3-oxide
• Chemical family: Organochlorine
• Case number: 0014
• CAS registry number: 115-29-7
• OPP chemical code: 079401
• Empirical formula: C9H6CL6O3S
• Molecular weight: 406.95 daltons
Trade and other names: Thiodan®
• Basic manufacturers: Bayer CropScience, Makhteshim-Agan of North
America, FMC Corporation, Gowan, Platte
Chemical, and Drexel Company.
Endosulfan is often referred to generically as a "cyclodiene-type" insecticide, but it
contains only one double bond. Technical endosulfan (70% a- and 30% p-endosulfan) is a light
to dark brown crystalline solid. The melting point of the a-isomer ranges from 108-110° C and
the melting point of the p-isomer is 208-210° C. The melting point of technical endosulfan
ranges from 70 to 100° C. The vapor pressure of CC-endosulfan is 3.0 x 10"6 mm Hg, P-
endosulfan 7.2 x 10"7 mm Hg, and technical endosulfan 1 x 10"5 mm Hg at 25 °C. Technical
endosulfan has a water solubility that varies from insoluble to -0.33 mg/L at 25 °C, but has
appreciable lipophilicity (log Pow 4.445 to 5.689).
C. Use Profile
The following information is based on the currently registered uses of endosulfan:
Type of Pesticide: Insecticide/Acaricide
Summary of Use Sites:
Food Crops: barley, beans (dry and succulent), blueberries, broccoli, brussels
sprouts, cabbage, carrots, cauliflower, celery, collards, kale, corn (fresh only),
cucumbers, eggplants, grapes, peppers, oats, lettuce, melons, mustard greens,
pineapples, rye, potatoes, pumpkins, spinach, squash, sweet potatoes,
-------
strawberries, tomato, turnip, apples, apricots, almonds, cherries, filberts,
macadamia nuts, nectarines, peaches, pecans, pears, plums, prunes, walnuts, and
wheat.
Other Agricultural Sites: Alfalfa (seed only), radish (seed only), cotton, rutabaga
(seed only), clover (seed only), kohlrabi (seed only), and tobacco.
Residential: None
Public Health: None
Other Nonfood: Christmas tree plantations, woody plants, peaches (root dip only),
cherry and plum roots and crowns, whole strawberry plants, shade trees, citrus
(non-bearing), tobacco, nursery stock, ornamental plants and shrubs.
Target Pests:
Agricultural: Meadow spittlebug, Army cutworm, Aphids, Bean leaf
skeletonizer, Cowpea curculio, Cucumber beetle, Flea beetle, Green stink bug,
Leafhoppers, Mexican bean beetles, Cabbage looper, Cabbage worm, Cabbage
aphid, Cucumber beetles, Whitefly, Cutworms, Diamondback moth, Corn
earworm, Boll weevil, Bollworm, Lygus bugs, Thrips, Melonworm, Pickleworm,
Rindworm, Squash beetle, Squash bug, Blister beetle, Potato beetle, Rose chafer,
Pepper maggot, Cinch bug, Crown mite, June bug, Harlequin bug, Grape
phylloxera, and Grape leafhopper.
Orchards: Aphids (including Apple aphids, Black cherry aphid, Black peach
aphid, Green peach aphid, Rosy apple aphids, Black pecan aphid, Filbert aphid,
Rusty plum aphids, Wooly apple aphids), Apple rust mites, Green fruitworm,
Tarnished plant bug, Tentiform leafminers, Whitefly leaf hoppers, Peachtree
borer, Peach twig borer, Plum rust mite, Bud moth, Bud mites, Twig mites,
Filbert leafroller, Filbert bud mite, Pecan nut casebearer, and Spittlebug.
Ornamental Trees and Shrubs: Leather leaf fern borer, Aphids, Cyclamen mite,
Rose chafer, Whitefly, Dogwood borer, Lilac borer, Colley spruce gall adelgid,
Douglas fir needle midge, Walnut aphid, and Stink bug.
Formulation Types Registered: Endosulfan is formulated for occupational use
as a technical grade manufacturing product (95 percent active ingredient [ai]),
emulsifiable concentrate (EC) (9 percent to 34 percent active ingredient), and a
wettable powder (WP) (1 percent to 50 percent active ingredient). The wettable
powder is frequently packaged in water soluble bags.
-------
Methods and Rates of Application:
Equipment - Endosulfan can be applied by groundboom sprayer, fixed-wing
aircraft, chemigation (potatoes only), airblast sprayer, rights-of-way sprayer, low
pressure handwand sprayer, high pressure handwand sprayer, backpack sprayer
and dip treatment.
Rates of Application- The crop groupings with their corresponding maximum
label application rates are as follows (both formulations unless noted, EC =
emulsifiable concentrate, WP = wettable powder formulations):
Agricultural crops (vegetables and field crops), alfalfa (seed only, 1 Ib ai/A EC);
barley, rye, oats and wheat (0.75 Ib ai/A); beans and tomatoes (1 Ib ai/A); clover
(0.5 Ibs ai/A EC); blueberries (1.5 Ib ai/A); broccoli, cabbage, collard, lettuce,
melons, and mustard greens (1 Ib ai/A or 2 Ib ai/A for seed); brussels sprouts,
carrots, cauliflower, celery, cucumbers, eggplants, peas, peppers, potatoes,
pumpkins, spinach, and squash (1 Ib ai/A); cotton and corn (fresh only) (1.5 Ib
ai/A); grapes (1.5 Ib ai/A or 0.005 Ib ai/gallon); kale (0.75 Ib ai/A or 2 Ib ai/A for
seed); kohlrabi, radish, turnip and rutabaga (2 Ib ai/A seed only); strawberries,
pineapples and sweet potato (2 Ib ai/A); and tobacco (1.5 Ib ai/A WP, 1 Ib ai/A
EC).
Fruit and nut trees (orchard crops). apples (2.5 Ib ai/A or 0.005 Ib ai/gal);
apricots, peach, and nectarines (3 Ib ai/A or 0.0025 Ib ai/gal); almonds, cherries,
pears, plums, and prunes (2.5 Ib ai/A or 0.04 Ib ai/gallon); filberts (hazelnuts 21b
ai/A or 0.005 Ib ai/gallon); macadamia nuts (3.0 Ib ai/A or 0.01 Ib ai/gallon);
pecans (3 Ibs ai/A or 0.0075 Ib ai/gallon); walnuts (2 Ib ai/A or 0.02 Ib ai/gallon
WP, 2.5 Ib ai/A or 0.04 Ib ai/gallon EC). A currently registered label (EPA reg #
34704-516) contains a higher application rate (7.5 Ib ai/A) for pecans and
macadamia nuts than is listed above. At this time only the 3.0 Ib ai/A rate for
pecans and macadamia nuts is being supported and this assessment therefore only
assesses these crops for a 3.0 Ib ai/A maximum application rate.
Ornamental Trees and Shrubs, shade trees, citrus (non-bearing and nursery
stock), shrubs, nursery stock, Christmas tree plantations, and woody plants (1 Ib
ai/A or 0.01 Ib ai/gallon).
Root dip. cherry, peaches, and plum roots and crowns (0.05 Ib ai/gallon) and
whole strawberry plants (0.01 Ib ai/gallon EC).
Bark Treatment: apricot, cherry, grapes, nectarines, peach, plums and prunes (see
above for application rates, applied with high pressure handwands and rights-of-
way sprayers).
-------
Use Classification: General use
D. Estimated Usage of Pesticide
This section summarizes the best estimates available for many of the pesticide uses of
endosulfan, based on available pesticide survey usage data for the years 1990 through 1999. A
full listing of all uses of endosulfan, with the corresponding use and usage data for each site, has
been completed and is in the "Quantitative Use Assessment" document dated September 10,
2000, which is available in the public docket and on the Agency's website:
http://www.epa.gov/pesticides/endosulfan. 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. Total average annual use of endosulfan is estimated at approximately 1.38
million pounds of active ingredient (Ibs ai), according to Agency and registrant estimates.
This long-term average is not necessarily consistent with some recent trends. Data from
USD A (Agricultural Chemical Usage, Field Crop Summary, 1999, 2000, 2001; Agricultural
Chemical Usage, Fruit and Nut Summary., 1999; Agricultural Chemical Usage, Vegetable
Summary, 2000) and other EPA sources appear to indicate declining use of endosulfan in U.S.
agriculture. This decline is driven mainly by replacement of endosulfan by other insecticides for
use on small grains and soybeans. Usage on fruit and nut crops may also be decreasing, although
the decline is not as clear and may be sensitive to yearly fluctuation in pest problems. Usage on
vegetable crops appears steady and may be increasing. Within these broad categories, there may
be significant shifts in use patterns in response to the dynamics of the agricultural system (e.g.,
changes in crop area), pest populations (e.g., pest outbreaks) and changes in pesticide availability
(e.g., new pesticides registered and restrictions on old pesticides).
Table 1.
Endosulfan Estimated Usage
Crop
Lbs. A.I. Applied (wghtd
Avg. in 000 pounds)1
Percent Crop Treated
(Weighted Avg.)
Percent Crop Treated
(Likely Max)
Food Commodities
Alfalfa (seed) (non food)
Almonds
Apples
Apricots/Nectarines
Barley
Beans, Dry
Beans, Lima
Beans, Snap Fresh
Beans, Snap Processed
Blueberries
Broccoli
Brussels Sprouts
10
<1
110
2
<1
5
Not Available
2
3
1
16
<1
<1%
<1%
13%
2%
1%
1%
2%
2%
2%
2%
13%
2%
<1%
<1%
20%
4%
1%
3%
6%
6%
6%
6%
26%
10%
-------
Crop
Cabbage, Fresh and Processed
Cantaloupes
Carrots
Cauliflower
Celery
Cherries, Sweet and Tart
Citrus - Grapefruit
Citrus - Oranges
Citrus - Other2
Collards
Corn, Sweet
Cucumbers, fresh and
processed
Eggplant
Grapes
Hazelnuts (Filberts)
Lettuce
Macadamia Nuts
Melons, Honey dew
Mustard Greens
Oats/Rye
Peas, Dry
Peas, Green
Pears
Pecans
Peppers (bell and hot)
Peaches
Pineapple (flowering ac)
Plums and Prunes
Potatoes, White
Potatoes, Sweet
Pumpkins
Roots/Tubers
Spinach, Fresh
Strawberries
Squash
Tomatoes
Vegetables, Other Leafy
Walnuts
Lbs. A.I. Applied (wghtd
Avg. in 000 pounds)1
18
39
1
4
2
5
3
4
<1
1
4
27
3
17
2
58
Not Available
6
Not Available
<1
<1
1
35
59
14
29
1
8
120
20
11
13
1
9
44
55
Not available
1
Percent Crop Treated
(Weighted Avg.)
14%
31%
2%
9%
6%
3%
1%
<1%
<1%
6%
<1%
8%
41%
1%
7%
14%
7%
19%
6%
<1%
<1%
<1%
20%
11%
12%
7%
2%
3%
10%
31%
20%
4%
4%
14%
40%
6%
<1%
0%
Percent Crop Treated
(Likely Max)
27%
57%
5%
32%
11%
7%
5%
1%
<1%
7%
1%
15%
83%
6%
18%
31%
30%
58%
17%
<1%
4%
4%
48%
18%
17%
17%
6%
7%
16%
46%
30%
6%
11%
21%
84%
11%
5%
1%
-------
Crop
Watermelon
Lbs. A.I. Applied (wghtd
Avg. in 000 pounds)1
40
Percent Crop Treated
(Weighted Avg.)
12%
Percent Crop Treated
(Likely Max)
17%
Non-Food Sites
Cotton
Tobacco
286
63
2%
8%
4%
12%
Ornamentals
Horticultural Nurseries Stock
50
Not Available
Not Available
1 Usage data primarily covers 1990 to 1999. Calculations of the above numbers are displayed as rounded.
2 Calculations of the above numbers may not appear to agree because they are displayed as rounded:
to the nearest 1000 for acres treated or Ib. a.i.
Sources:
Agricultural (Crop) Sites: USDA Agricultural Chemical Usage Reports, NCFAP, and various proprietary data sources, including
Doane, Maritz, Mike Buckley.
Pineapple estimates from Calvin Oda, Pineapple Growers Assoc. of Hawaii, 4/21/99, memo to Nako;
Macadamia nut estimates from Alan Yamaguchi, Hawaii Macadamia Nut Assoc., 4/21/99, personal communications with Nako.
USDA, Biological and Economic Assessment of Pest Management in the United States Greenhouse and Nursery Industry,
NAPIAP Report, l-CA-96;
1993 Certified/Commercial Pesticide Applicator Survey; Kline; SRI.
III. Summary of Endosulfan Risk Assessments
The purpose of this summary is to assist the reader in better understanding the
conclusions reached in the assessments by identifying the key features and findings of the risk
assessments conducted for endosulfan. Following is a list of EPA's revised human health and
ecological risk assessments and supporting information that was used to formulate the findings
and conclusions for the pesticide endosulfan. The listed documents may also be found on the
Agency's web page at www.epa.gov/pesticides/and in the public docket.
Human Health Risks
• Assessment of the Dietary Cancer Risk of Hexachlorobenzene and Pentachlorobenzene
as impurities in Chlorothalonil, PCNB, Picloram, and several other pesticides., February
26, 1998.
• Product Chemistry Chapter for the Reregi strati on Eligibility Decision, December 18,
1998.
• Review of Endosulfan Incident Reports, January 18, 2000.
• Re-Evaluation of Toxicology Endpoint Selection for Dermal and Inhalation Risk
Assessments and 3X Safety Factor for Bioaccumulation, February 7, 2002.
• Revised Residue Chemistry Chapter For The Endosulfan Reregistration Eligibility
Decision (RED) Document, February 14, 2002.
• Report of the FQPA Safety Factor Committee, February 14, 2002.
• Third Revision of Occupational and Residential Exposure Assessment and
Recommendations for the Reregistration Eligibility Decision Document, February 26,
2002.
• Anticipated Residues and Revised Chronic Dietary Exposure Analyses, February 28,
2002.
-------
• New FQPA and PDF Data, Anticipated Residues, and Revised Acute and Chronic
Dietary Exposure Analyses, April 22, 2002.
• Supporting documentation for findings of FQPA Safety Committee on February 11,
2002, May 9, 2002.
• Reevaluation of the HED Risk Assessment for the Endosulfan Reregistration Eligibility
Decision (RED) Document, May 30, 2002.
• New FQPA, PDF, and Processing Data, Anticipated Residues, and Revised Acute and
Chronic Dietary Exposure Analyses, July 19, 2002
Environmental Fate and Ecological Effects
• Final EFED Risk Assessment for the Reregistration Eligibility Decision on Endosulfan,
February 26, 2002.
• Endosulfan and Endosulfan Sulfate: Drinking Water EECs in Surface Water for Use in
the Human Health Risk Assessment, July 3, 2002.
A. Human Health Risk Assessment
EPA issued its preliminary risk assessments for endosulfan on January 31, 2001 (Phase 3
of the TRAC process). In response to comments and studies submitted during Phase 3, the risk
assessments were updated and refined. Major revisions to the human health risk assessment are
listed below:
Adjusted dietary risk estimates to reflect FQPA Safety Factor of 10X.
• Use of new toxicological endpoints for dermal risk assessment. These data affect the
lowest observed adverse effect level, and no observed adverse effect level used in the
dermal risk assessments.
2000 PDF data was incorporated in the dietary assessment.
Processing factors for pear juice, pineapple juice, raisins, and canned fruits and
vegetables were incorporated in the dietary assessment.
• Recalculated Tier II drinking water EECs incorporating the Index Reservoir and Percent
Cropped Area.
Incorporated updated % crop treated values.
1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all toxicity studies submitted and has determined that the
toxicity database is sufficiently complete except for the data identified in Section V, and that it
supports a reregi strati on eligibility determination for all currently registered uses. Further details
on the toxicity of endosulfan can be found in the document "Endosulfan: Reevaluation of the
-------
HED Risk Assessment for the Endosulfan Reregi strati on Eligibility Decision (RED) Document,"
dated May 30, 2002, and related documents. A brief overview of the studies and safety factors
used for the dietary (food) risk assessment is outlined in Table 2 in this document.
b. FQPA Safety Factor
The FQPA Safety Factor of 10X was retained for endosulfan. A weight-of-the-evidence
approach indicated that there were no reliable data available to address concerns or uncertainties
raised by the following matters: 1) evidence for increased susceptibility of young rats, (2)
additional evidence for endocrine disruption, 3) uncertainty regarding the neuroendocrine effects
in the young, and 4) the need for a developmental neurotoxicity study (DNT). The FQPA safety
factor (lOx) is applicable for all populations when assessing acute and chronic dietary exposure.
There are no longer any residential uses for this chemical, so the FQPA Safety factor does not
apply to the short-term or intermediate-term exposure scenarios. More information concerning
the FQPA Safety Factor can be found in the document" Endosulfan: Report of the FQPA Safety
Factor Committee" dated February 13, 2002, and related documents.
Although developmental toxicity was only seen at or above parentally toxic doses, there
were treatment-related clinical signs of neurotoxicity following oral exposures in the rat, rabbit,
and dog, and via the dermal route in rats. The acute neurotoxicity study was reviewed and found
to be acceptable/guideline. The subchronic neurotoxicity study has not been received by the
Agency and remains a data gap. The Agency re-reviewed the hazard and exposure data for
endosulfan and concluded that a DNT study in rats should be requested for endosulfan due to
concern for: 1) fetal effects reported in the open literature; 2) the severity of effects seen in
female offspring of the F0 generation (increased pituitary) and Fxb generation (increased uterine
weights) at the high-dose when compared to the toxicity observed in parental animals at this
dose in the two-generation reproduction study in rats; and 3) because the subchronic
neurotoxicity study will only address the neuropathological concerns resulting from exposure to
endosulfan in adults. A developmental neurotoxicity study will provide the critical data needed
to determine the potential toxic effects of endosulfan on the developing fetal nervous system.
Under the conditions of the available Agency guideline studies, there is no evidence of
enhanced susceptibility of the offspring to exposure to endosulfan. However, a recent review by
the Agency for Toxic Substances and Disease Registry \Toxicological Profile for Endosulfan
(Update). ATSDR. September 2000] reported the results of non-guideline studies which
demonstrated that young rats may be more susceptible than older rats upon exposure to
endosulfan. Studies conducted by Sinha et al. (1995 & 1997) and Zaidi et al. (1985) illustrate
effects to the offspring at doses lower than those showing effects in adults. Sinha et a/.(1995 &
1997), treated both three week and three month old rats orally. Decreased intratesticular
spermatid count and increased percentage of abnormal sperm were seen in three week old rats at
doses lower than those eliciting similar effects in three month old rats. Zaidi (1985) dosed
neonatal rat pups for 25 days intraperitoneally and found increased serotonin binding to the
frontal cortical membranes of the brain and increased aggressive behavior. Adults exposed in a
similar manner did not display these effects.
10
-------
There is evidence for endocrine disruption both in studies submitted to the Agency and
those published in the open literature. In an National Cancer Institute (NCI) chronic
toxicity/carcinogenicity study in rats, endosulfan induced testicular atrophy and parathyroid
hyperplasia. In the multi-generation reproduction study, increased pituitary and uterine weights
were seen. Endosulfan is considered to be a potential endocrine disrupter. Substances that act as
endocrine disrupters may perturb the endocrine system in a variety of ways including, but not
limited to, interfering with the synthesis, secretion, or transport of hormones in the organism.
The endocrine system integrates a variety of CNS-pituitary-target organ pathways that not only
affect reproductive or sexually regulated parameters but also regulate a wide array of bodily
functions and homeostasis.
c. Population Adjusted Dose (PAD)
The PAD is a term that characterizes the dietary (food) risk of a chemical and reflects the
Reference Dose (RfD), either acute or chronic, that has been adjusted to account for the FQPA
safely factor (i.e., RfD / FQPA safety factor). The RfD is calculated by taking the no observed
adverse effect level (NOAEL) from an appropriate study and dividing it by an uncertainty factor
(i.e., NOAEL/UF). A risk estimate that is less than 100% of the acute or chronic PAD does not
exceed the Agency's risk concern. In the case of endosulfan, the FQPA safety factor is lOx;
therefore, the acute or chronic PADs are equivalent to the acute and chronic RfDs divided by 10,
respectively. The aPAD for endosulfan is 0.0015 mg/kg/day. The cPAD for endosulfan is
0.0006 mg/kg/day. The basis for the aPAD and the cPAD are summarized in Table 2 below.
Table 2.
Summary of the Toxicological Endpoints for Endosulfan
Exposure
Scenario
Acute Dietary
Chronic Dietary
Dose
(mg/kg/day)
NOAEL =1.5
UF = 100
rljrA 5>r — 1U
NOAEL = 0.6
UF = 100
T7OP A QT7 1 fl
Endpoint
Oral LOAEL = 3 mg/kg/day; based on
increased incidence of convulsions seen in
female rats within 8 hours after dosing.
Study
Acute neurotoxicity study in
rats
Acute RfD = 0.015 mg/kg/day
aPAD = 0.0015 mg/kg/day
LOAEL = 2.9 mg/kg/day based on
reduced body weight gain, enlarged
kidneys, increased incidences of marked
progressive glomerulonephrosis; & blood
vessel aneurysms in male rats.
Combined chronic
toxicity/carcinogenicity study
in rats
Chronic RfD = 0.006 mg/kg/day
cPAD = 0.0006 mg/kg/day
d. Exposure Assumptions
The Agency conducts dietary (food) risk assessments using the dietary exposure
evaluation model (DEEM™), which incorporates consumption data generated in USDA's
continuing survey of food intakes by individuals, 1989-1992. For the assessment of dietary
11
-------
(food) exposure to residues of endosulfan, monitoring data generated through the USDA
Pesticide Data Program (PDF) and through the Food and Drug Administration (FDA)
Surveillance Monitoring Program were used for most crops. Anticipated residue values from
crop residue field trial studies, and percent crop-treated data were used for cotton, macadamia
nuts, filberts, pecans, and walnuts.
The Agency has developed procedures for handling FDA surveillance monitoring data in
dietary exposure analyses in order to generate more refined probabilistic dietary exposure
estimates. In the FDA data, if there are significant differences between domestic and import
samples, either in terms of likelihood of detected residues or residue levels themselves, then it
would be most desirable to "weight" the FDA data such that it better reflects the proportionate
"mix" between domestic and foreign produce which the U.S. population consumes. Additional
estimates of the percent of commodity imported as well as imported %CT are also incorporated.
The crops for which these procedures were incorporated are dried beans, blueberries,
cauliflower, fresh sweet corn, melons (except cantaloupe), fresh succulent peas, hot peppers,
plums, and summer squash.
For acute probabilistic dietary risk assessments, the entire distribution of single-day food
consumption events is combined with a distribution of residues to obtain a distribution of
exposure in mg/kg/day. Chronic dietary (food) risk assessments use the three-day average of
consumption for each subpopulation combined with residues in commodities to determine
average exposure in mg/kg/day.
e.
Food Risk Characterization
Generally, a dietary (food) risk estimate that is less than 100% of the acute or chronic
Population Adjusted Dose does not exceed the Agency's risk concern. Acute risk estimates from
exposures to food, associated with the use of endosulfan exceed the Agency's level of concern
for some population subgroups. For example, for exposure resulting from applications of
endosulfan, for the most exposed population subgroup, children 1-6 years old, the percent acute
PAD value is 150% at the 99.9th percentile of exposure from consumption of food alone. The
crops that contributed the most to the risks of concern are succulent beans and succulent peas.
The results of the acute dietary (food) assessment are summarized in the Table 3.
Table 3.
Summary of Acute Dietary (food) Risk Assessment
Population Subgroup
U.S. General Population
All Infants
Children 1-6
Children 7-12
aPAD
0.0015
0.0015
0.0015
0.0015
Food Exposure
0.0012
0.0014
0.0022
0.0014
% aPAD
80%
94%
150%
95%
Chronic dietary (food) exposure estimates are below the Agency's level of concern for all
subpopulations. For the most highly exposed subpopulation, children 1-6 years old, the percent
chronic PAD value is 17% from consumption of food alone.
12
-------
2. Dietary Risk from Drinking Water
Dietary (drinking water) exposure to pesticides can occur through ground water and
surface water contamination. EPA considers both acute (one day) and chronic (lifetime)
drinking water risks and uses either modeling or actual monitoring data, if available, to estimate
those risks. Modeling is considered to be an unrefined assessment. Limited water monitoring
data exist for endosulfan; therefore, modeling was used to estimate drinking water risks from
these sources.
The GENEEC and PRZM-EXAMS models were used to estimate surface water
concentrations, and SCI-GROW was used to estimate groundwater concentrations. All of these
are considered to be screening models, with the PRZM-EXAMS model being somewhat more
refined than the other two.
a. Surface Water
The Tier II PRZM-EXAMS screening model is used to estimate upper-bound
environmental concentrations (EECs) in drinking water derived from surface water. This model,
in general, is based on more refined, less conservative assumptions than the Tier I GENEEC
screening model. The Agency also used the recently implemented Index Reservoir (IR) and
Percent Crop Area (PCA) modifications to the Tier II PRZM-EXAMS model to calculate upper-
bound EECs for endosulfan and its degradate, endosulfan sulfate, in drinking water derived from
surface water. Applying the IR and PCA modifications, acute modeled EECs for endosulfan in
surface water range from 4.49 ppb to 23.86 ppb depending on the crop site. Chronic modeled
EECs for endosulfan in surface water range from 0.53 ppb to 1.5 ppb, depending on the crop site.
Monitoring data for endosulfan and endosulfan sulfate in surface water are available but
not of sufficient quality to be used in a quantitative risk assessment. A review of the STORET
database for a- and p-endosulfan, unspecified endosulfan residues, and endosulfan sulfate
showed numerous detections. The STORET data are not reliable enough to enable an accurate
quantitative assessment of the endosulfan distribution throughout the U.S., but it does give some
insight into where endosulfan is being found. The mean concentration found in this data is 0.17
ppb, with a standard deviation of 0.98 ppb. The 90th percentile value (one in ten year value) was
0.31 ppb and the median value was 0.03 ppb. However, as mentioned above, there are
limitations to this data which make it unuseable for quantitative risk assessment. As such, the
data do not necessarily represent the most vulnerable sites or sampling at peak exposure times
and little is known about actual sample conditions. In addition, the limits of detection vary
widely depending on the purpose of the monitoring and the availability of analytical methods
and equipment so that reported non-detections do not necessarily mean that endosulfan was not
present where a non-detect was reported.
The National Sediment Quality Survey (U.S. EPA, 1997) reported detections of
endosulfan residues in stream sediments in 30 out of 76 watersheds tested for endosulfan. The
watersheds are located in 12 states, ranging from Rhode Island to California and from
Mississippi to Michigan. As with the STORET data, one of the sources of data used in the
survey, this summary provides more of a qualitative evaluation of the extent to which endosulfan
may be found in the environment rather than a quantitative assessment of endosulfan occurrence.
13
-------
The U.S. Geological Survey (USGS) in its National Water Quality Assessment (NAWQA)
program is not currently analyzing for endosulfan.
b. Ground Water
The Tier I screening model, SCI-GROW, was used to estimate drinking water
concentrations derived from groundwater. The acute and chronic EEC for endosulfan in
groundwater is 0.012 ppb. This includes potential residues of endosulfan sulfate in addition to
endosulfan. The Agency believes that the potential for endosulfan to reach ground water is
limited to acidic to neutral soils and aquifers where preferential flow may be a prevalent pathway
to ground water or where the ground water is shallow and is overlain by highly permeable soils.
Available evidence suggests that the transformation products - endosulfan sulfate and
endosulfan diol - may be persistent. Endosulfan sulfate is similar in mobility to the parent
endosulfan.
The Pesticides in Ground Water Database (PGWDB) reports detections of endosulfan,
ranging from trace to <20 ppb, in 1.3% of 2410 discrete samples (32 wells). Detections were
reported in California, Maine, and Virginia. All sampling was conducted on or before the year
1989. The abbreviated nature of the PGWDB does not capture important factors such as depth
of the water table, soil permeability, proximity of crops to wells, usage (application) of the
chemical in the years prior to sampling, suitability of the analytical methodology used and/or
limits of detection. Endosulfan sulfate was detected in 0.3% of the samples (6 out of 1,969),
with detections ranging from < 0.005 to 1.4 ppb. The detections were reported in Indiana and
New York. Sampling occurred at or prior to 1990.
c. Drinking Water Levels of Comparison (DWLOC)
To determine the maximum allowable contribution from water containing pesticide
residues permitted in the diet, the Agency first looks at how much of the overall allowable risk is
contributed by food (and if appropriate, residential uses) then determines a "drinking water level
of comparison"(DWLOC) to determine whether modeled or monitoring levels exceed this level.
The Agency uses the DWLOC as a surrogate to capture risk associated with exposure from
pesticides in drinking water. The DWLOC is the maximum concentration in drinking water
which, when considered together with dietary (food) exposure, does not exceed a level of
concern.
The results of the Agency's drinking water analysis are summarized here. Details of this
analysis, which used screening models, are found in the documents "Endosulfan: Reevaluation
of the HED Risk Assessment for the Endosulfan Reregi strati on Eligibility Decision (RED)
Document" dated May 30, 2002 and "a- and p-Endosulfan and Endosulfan Sulfate: Drinking
Water EECs in Surface Water for Use in the Human Health Risk Assessment" dated July 3,
2002.
14
-------
Since acute risk exposures to endosulfan in food alone pose a potential risk of concern
for children 1-6 years of age additional exposures from water would increase the concern and
therefore the DWLOC for this population is zero. These drinking water risk estimates are
summarized below in Table 4.
Table 4.
Endosulfan Drinking Water Levels of Comparison for Acute Dietary Exposure
Population
Subgroup
U.S. Population
Females (13-50 yrs)
Infants <1 yr
Children 1 -6 yrs
Acute PAD
(mg/kg/day)
0.0015
0.0015
0.0015
0.0015
Food
Exposure
(mg/kg/day)
@ 99.9th
percentile
0.0012
0.00098
0.0014
0.0023
Maximum
Allowable
Water
Exposure
(mg/kg/day)
0.0003
0.00052
0.0001
0
DWLOCacute
(ppb)
3
16
<1
0
Surface
Water Peak
EEC
(ppb
23.86
23.86
23.86
23.86
Ground
Water EEC
(Ppb)
0.012
0.012
0.012
0.012
Chronic risk estimates from exposures to food, do not exceed the Agency's level of
concern for the U.S. general population and all population subgroups. The chronic dietary (food
only) risk estimate is 17% of the cPAD, for the most highly exposed population subgroup,
children ages 1-6 years of age. Based on these estimates, the Agency can conclude with
reasonable certainty that residues of alpha and beta endosulfan and endosulfan sulfate combined
with drinking water, would not likely result in a chronic dietary risk to infants, children, and
adults that further exceeds the Agency's level of concern (Table 5).
Table 5.
Drinking Water Levels of Comparison for Chronic Dietary Exposure
Population
Subgroup
U.S. Population
Females (13-50 yrs)
Infants <1 yr
Children 1 -6 yrs
Chronic
PAD
(mg/kg/day)
0.0006
0.0006
0.0006
0.0006
Food
Exposure
(mg/kg/day)
0.000038
0.000027
0.000045
0.00010
Maximum Allowable
Water Exposure
(mg/kg/day)
0.00056
0.00057
0.00045
0.00050
DWLOCchronic
(ppb)
20
17
6
5
Surface Water
Chronic EEC
(Ppb)
1.5
1.5
1.5
1.5
Ground
Water EEC
(Ppb)
0.012
0.012
0.012
0.012
3. Aggregate Risk
An aggregate risk assessment examines the combined risk from dietary exposure (food
and drinking water routes) and any non-occupational exposures (residential use). Acute and
chronic aggregate risk assessments were conducted for endosulfan. Residential uses of
endosulfan have been voluntarily canceled by the technical registrants. Therefore, aggregate
short-term exposures were not estimated. Results of the aggregate risk assessment are
summarized here, and are discussed in the endosulfan human health risk assessment.
The Agency was only able to quantify food sources of dietary exposure to endosulfan
because dietary exposures through drinking water have only been estimated using models.
15
-------
Neither adequate groundwater or surface water monitoring data were available to estimate
potential drinking water exposures to endosulfan.
Acute Aggregate Risk Assessment: Potential acute dietary risks from food sources alone
exceed the Agency's level of concern. The most exposed subpopulation, children 1-6, are
estimated to consume 150% of the acute PAD at the 99.9th percentile of exposure, based on
highly refined exposure estimates. Therefore, there is no additional room in the "risk cup" for
exposure via drinking water (DWLOC = 0).
Chronic Aggregate Risk Assessment: In the case of the food component of the chronic
aggregate risk assessment, risks are well below the Agency's level of concern. No more than
17% of the chronic PAD is consumed for children 1-6. Further, potential drinking water risks
from exposure to drinking water sources do not exceed the chronic DWLOCs and, therefore, do
not exceed the Agency's level of concern.
4. Occupational Risk
Occupational handlers can be exposed to endosulfan through mixing, loading and/or
applying a pesticide or re-entering treated sites. Occupational handlers of endosulfan include
individual farmers or growers who mix, load and/or apply pesticides and professional or custom
agricultural applicators. The post-application occupational risk assessment considered exposures
to workers entering treated sites in agriculture. Risk for all of these potentially exposed
populations is measured by a Margin of Exposure (MOE), which determines how close the
occupational exposure comes to a NOAEL. Generally, MOEs greater than 100 are not of
concern. Restricted Entry Intervals (REIs) are 24 hours on current endosulfan labels. The
Agency has determined that there are potential mixer, loader, applicator as well as post-
application exposures to occupational handlers.
a. Toxicity
The toxicity of endosulfan is integral to assessing the occupational risk. The Agency has
conducted short term dermal and inhalation exposure assessments for the occupational handler.
In addition, the Agency has conducted short term and intermediate term postapplication dermal
exposure assessments for occupational uses.
All risk calculations are based on the most current toxicity information available for
endosulfan, including a 21-day dermal toxicity study in rats for short-term and intermediate-term
(post-application only) exposure durations. An uncertainty factor (UF) of 100 was applied to the
risk assessment: 1 Ox to account for interspecies extrapolation and lOx to account for intraspecies
variability. The toxicological endpoints and other factors used in the occupational risk
assessments for endosulfan are listed below.
16
-------
Table 6. Summary of Toxicological Endpoints and Other Factors Used in the Human
Occupational Risk Assessment for Endosulfan
Route / Duration
Short- and Intermediate-term
Dermal (one day to one
month; one month to several
months )
Short- and Intermediate-term
Inhalation
(one day to one month; one
month to several months )
NOAEL
(mg/kg/day)
12.0
0.2
Effect
Mortality in females at 27
mg/kg/day (LOAEL)
Decreased body -weight gain and
decreased leukocyte counts in
males and increased creatinine
values in females at 0.40
mg/kg/day (LOAEL)
Study
21 -day dermal
toxicity study in rats
21 -day inhalation
study in rats.
Uncertainty
Factors
Interspecies: lOx
Intraspecies: lOx
Interspecies: lOx
Intraspecies: lOx
Endosulfan is highly toxic following acute oral exposure and moderately toxic following
acute inhalation exposure. In rats, oral median lethal doses (LD50 values) are 82 mg/kg (males)
and 30 mg/kg (females). Median lethal concentrations (LC50 values) in rats following acute
inhalation exposure range from 0.16 to 0.5 mg/L. Endosulfan is considerably less lethal,
however, following acute dermal exposure (LD50 is 2.0 g/kg).
Endosulfan is an eye irritant in rabbits (Toxicity Category I) but is not a dermal irritant or
sensitizer. Refer to Table 7 below for a summary of the acute toxicity of endosulfan.
Table 7.
Summary of Results from Acute Toxicity Studies of Technical Endosulfan
Guideline
Number
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute Oral
Acute Dermal
Acute Inhalation
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
MRID
41183502
41183503
41183504
41183505
41183506
41183507
Results
LD50 = 82 mg/kg in cf
LD50 = 30 mg/kg in ?
LD50 = 2000 mg/kg
LC50 = 0.16-0. 5 mg/L
Eye irritant
(Residual opacity at day 13)
Non-irritant
Not a dermal sensitizer
Toxicity
Category
I
III
II
I
IV
NA
b. Occupational Exposure
Three chemical-specific dislodgeable foliar residue studies that were submitted to the
Agency by the technical registrant were used to evaluate post-application exposures. Chemical-
specific exposure data for handlers were not available for endosulfan, so risks to pesticide
handlers were assessed using data from the Pesticide Handlers Exposure Database (PHED). In
addition, standard assumptions about average body weight, work day, area treated daily and
volume of pesticide handled were used to calculate risk estimates. The quality of the data and
exposure factors represent the best sources of data currently available to the Agency for
completing these kinds of assessments. The exposure factors (e.g., body weight, amount treated
per day, protection factors, etc.) are all standard values that have been used by the Agency over
several years, and the PHED unit exposure values are the best available estimates of exposure.
17
-------
The quality of the data used for each scenario assessed is discussed in the Human Health
Assessment document for endosulfan, which is available in the public docket and on the
Agency's web page: http://www.epa.gov/pesticides/.
Calculations were completed for a range of maximum application rates for specific crops
available from endosulfan labels. These rates were assessed in order to bracket risk levels
associated with the various use patterns. Anticipated use patterns and application methods, range
of application rates and daily amount treated were derived from current labeling. On the
majority of endosulfan product labels, the number of maximum allowable applications typically
ranges between 1 and 3 per season or year, and does not exceed 5. The Agency uses acres
treated per day values that are thought to represent an eight hour workday for a particular type of
application equipment or specific crop.
Occupational handler exposure assessments are conducted by the Agency using different
levels of personal protection. The Agency typically evaluates all exposures with baseline
protection and then adds additional protective measures using a tiered approach to obtain an
appropriate MOE (i.e., increasing levels of protection). The lowest combination of personal
protective equipment (PPE) is baseline PPE. If required (i.e., MOEs are less than 100),
increasing levels of risk mitigation PPE are applied. If MOEs are still less than 100, engineering
controls are applied. In some cases, EPA will conduct an assessment using PPE or engineering
controls taken from a current label. The levels of protection that formed the basis for
calculations of exposure from endosulfan include:
Baseline: Long-sleeved shirt and long pants, shoes and socks.
• Minimum PPE: Baseline + chemical-resistant gloves and a dust/mist respirator.
• Maximum PPE: Coveralls over long-sleeved shirt and long pants, chemical
resistant gloves, chemical footwear plus socks, chemical resistant
headgear for overhead exposures, and an ov respirator.
Engineering controls: Engineering controls such as a closed cab tractor for application
scenarios, or a closed mixing/loading system such as a closed mechanical transfer system
for liquids or water soluble packaging for wettable powders. Some engineering controls
are not applicable for certain scenarios (e.g., for handheld application methods there are
no engineering controls that lower the exposures).
c. Occupational Handler Risk Summary
Inhalation and dermal exposure to endosulfan can result from occupational use. The
Agency assessed dermal and inhalation risks (MOEs) for each crop currently registered for
endosulfan. Dermal and inhalation MOEs were not aggregated but were assessed separately
because the end effects seen at the LOAEL were different. It is Agency policy not to aggregate
the risks (inhalation plus dermal) if the toxicological effects are not the same. Handler exposures
to endosulfan are expected to be short-term only (1 - 30 days) because of the types of crops on
which endosulfan is used. For endosulfan, occupational MOEs greater than 100 are not of risk
concern to the Agency.
18
-------
(1) Agricultural Handler Risk
EPA has determined that there are potential exposures to mixers, loaders, applicators, and
other handlers during usual use-patterns associated with endosulfan. The scenario numbers
below correspond to the scenario numbers detailed and discussed in Appendix A of the
Occupational and Residential Exposure Chapter of the HED risk assessment dated May 30,
2002. Based on the use patterns, 21 major occupational exposure scenarios were identified for
endosulfan:
• (la) mixing/loading liquid formulations for aerial application;
(Ib) mixing/loading liquid formulation for chemigation;
(Ic) mixing/loading liquid formulations for groundboom application;
(Id) mixing/loading liquid formulations for airblast application;
(le) mixing/loading liquid formulations for rights-of-way sprays;
• (If) mixing/loading liquid formulations for plant and root dip;
• (2a) mixing/loading wettable powders for aerial application;
• (2b) mixing/loading wettable powders for groundboom application;
• (2c) mixing/loading wettable powders for airblast application;
(2d) mixing/loading wettable powders for rights-of-way spray application;
(2e) mixing/loading wettable powders for plant and root dip;
(3) applying sprays with aerial equipment;
(4) applying sprays with a groundboom sprayer;
• (5) applying sprays with an airblast sprayer;
• (6) applying sprays with a rights-of-way sprayer;
• (7) applying dip treatment to roots, or whole plants;
• (8) mixing/loading/applying liquids with a low pressure hand wand;
(9) mixing/loading/applying wettable powders with a low pressure handwand;
(10) mixing/loading/applying liquids with a high pressure hand wand;
(11) mixing/loading/applying liquids with backpack sprayer; and
(12) flagging aerial spray applications.
There were three scenarios that were not evaluated due to a lack of data available to
conduct an assessment. These scenarios are mixing/loading/applying wettable powders with
backpack sprayer, mixing/loading/applying wettable powders with a high pressure hand wand
and application of liquids or wettable powders as a root dip/crown dip.
PPE requirements on current endosulfan labels range from no PPE listed to long sleeved
shirt and long pants, waterproof gloves, shoes, socks, chemical resistant headgear, respirator
with either an organic vapor removing cartridge with a prefilter or canister approved for
pesticides. Mixers and loaders must also wear a chemical resistant apron.
As summarized in Table 8, occupational risks are of concern (i.e., MOEs < 100) for many
scenarios, even when maximum PPE are utilized. Handler risks are also of concern for some
scenarios with engineering controls. Engineering controls are considered to be the maximum
19
-------
feasible mitigation. Twelve scenario/application rate combinations have risks that exceed the
Agency's level of concern based on application rates supported by the technical registrants.
These mainly involve mixing/loading liquids for aerial applications, mixing/loading wettable
powders for aerial applications, groundboom applications and airblast applications, application
using aerial equipment, application using airblast equipment, application using rights-of-way
sprayers and mixing/loading/applying using a high-pressure handwand.
Table 8. Summary of Occupational Handler Risks to Endosulfan
Exposure Scenario
(Scenario #)
Crop
Type/Use"
Range of
Application
Rates
(Ib ai/A)b
Acres Treated
Amount
Handled/
Dayc
Baseline5
Dermal
MOEd
Inhalation
MOEe
Minimum PPEg
Dermal
MOEd
Inhalation
MOEe
Maximum PPEh
Dermal
MOEd
Inhalation
MOEe
Engineering
Controls1
Dermal
MOEd
Inhalation
MOEe
Mixer/Loader Exposures
Mixing/Loading
Liquid Formulations
for Aerial
Application (la)
Mixing/Loading
Liquid Formulation
for Chemigation (Ib)
Mixing/Loading
Liquid Formulations
for Groundboom
Application (Ic)
Mixing/Loading
Liquid Formulations
for Airblast
Application (Id)
Mixing/Loading
Liquids for Rights-
of-way Spray
Application (le)
Mixing/Loading
Liquids for Plant and
Root Dip (If)
Mixing/Loading
Wettable Powders
for Aerial
Application (2a)
Mixing/Loading
Wettable Powders
for Groundboom
Application (2b)
clover
pineapple
pecans
small grains
cotton
potatoes
(Idaho)
clover
pineapple
small grains
cotton
Ornamental
Trees/Shrub
s
Hazelnuts
pecans
grapes
cherry
cherry,
peach and
plums
beans
sweet potato
peach
small grains
cotton
beans
sweet potato
small grains
cotton
0.5
2.0
3.0
0.75
1.5
1.0
0.5
2.0
0.75
1.5
1.0
2.0
3.0
0.005
0.04
0.05
1.0
2.0
3.0
0.75
1.5
1.0
2.0
0.75
1.5
350
1,200
350
80
200
10
40
100 Gallons
100 Gallons
350
1,200
80
200
2
0.41
0.28
0.32
0.16
0.83
7
2
2
1
29
4
2
58
7
58
0.65
0.32
0.22
0.25
0.13
3
1.4
1.5
0.76
67
17
11
13
7
33
290
73
78
39
1,200
150
97
2,300
290
2,300
0.93
0.47
0.31
0.36
0.18
4
2
2
1
210
52
35
41
20
100
910
230
240
120
3,700
460
300
7,300
910
7,300
14
7
5
6
3
62
31
33
16
330
83
56
65
32
170
-
360
390
190
-
-
490
-
-
-
5
2
2
2
1
20
10
11
5
-
71
47
55
27
-
-
-
-
-
-
-
-
-
18
9
6
7
4
81
40
43
22
-
170
110
130
65
-
-
-
-
-
-
-
-
-
-
-
10
5
3
4
2
41
20
22
11
-
140
93
110
54
-
-
-
-
-
-
-
-
-
-
-
240
120
82
95
48
1,100
540
570
290
-
-
-
-
94
-
-
-
-
-
-
-
-
-
-
-
170
83
56
65
32
730
360
390
190
20
-------
Exposure Scenario
(Scenario #)
Mixing/Loading
Wettable Powders
for Airblast
Application (2c)
Mixing/Loading
Wettable Powders
for Rights-of-way
Spray Treatment (2d)
Mixing/Loading
Wettable Powders
for Plants and Root
Dip (2e)
Crop
Type/Use"
Ornamental
Trees/
Shrubs
hazelnuts
peaches
grapes
walnut
cherry,
peach, and
plum
Range of
Application
Rates
(Ib ai/A)b
1.0
2.0
3.0
0.005
0.02
0.05
Acres Treated
Amount
Handled/
Dayc
10
40
1,000 Gallons
100 Gallons
Baseline5
Dermal
MOEd
23
3
2
45
11
45
Inhalation
MOEe
33
4
3
65
16
65
Minimum PPEg
Dermal
MOEd
490
62
41
990
250
990
Inhalation
MOEe
160
20
14
330
81
330
Maximum PPEh
Dermal
MOEd
-
81
54
-
-
-
Inhalation
MOEe
-
41
27
-
160
-
Engineering
Controls1
Dermal
MOEd
-
1,100
710
-
-
-
Inhalation
MOEe
-
730
490
-
-
-
Applicator Exposures
Applying Spray with
Aerial Equipment (3)
Applying Sprays
with a Groundboom
Sprayer (4)
Applying Sprays
with an Airblast
Sprayer (5)
Applying Sprays
with a Rights-of-way
Sprayer (6)
Applying Dip
Treatment to Roots,
or Whole Plants (7)
clover
pineapple
pecans
small grains
cotton
clover
pineapple
small grains
cotton
ornamental
trees
hazelnuts
pecans
grapes
cherries
cherry,
peach, plum
roots
0.5
2.0
3.0
0.75
1.5
0.5
2.0
0.75
1.5
1.0
2.0
3.0
0.005
0.04
0.05
350
1,200
80
200
10
40
1,000 Gallons
100 gallons
SeeEng. Controls
1,500
380
400
200
230
29
19
130
16
No Data
470
120
130
63
310
39
26
720
90
No Data
-
-
-
-
-
48
32
-
54
ND
-
-
-
310
-
190
130
-
450
ND
-
-
-
-
-
48
32
-
72
ND
-
-
-
-
-
-
-
-
-
ND
960
240
160
190
93
-
-
-
-
-
550
370
NF
NF
ND
1,200
290
200
230
110
-
-
-
-
-
-
-
NF
NF
ND
Mixer/Loader/Applicator Exposure
Mixing/Loading/App
lying Liquid
Formulations with a
Low Pressure
Handwand (8)
tobacco
(drench)
tomato
greenhouse
cherries
0.005
0.01
0.04
40 Gallons
42
21
5
2,300
1,200
290
9,800
4,900
1,200
-
-
-
-
-
-
-
-
-
NF
NF
NF
NF
NF
NF
21
-------
Exposure Scenario
(Scenario #)
Mixing/Loading/App
lying Wettable
Powders with a Low
Pressure Handwand
(9)
Mixing/Loading/App
lying Liquid with a
High Pressure
Handwand (10)
Mixing/Loading/App
lying Liquid with
Backpack Sprayer
(11)
Crop
Type/Use"
tomato/
tobacco
walnut
tobacco
(drench)
tomato
greenhouse
cherries
tobacco
(drench)
tomato
greenhouse
cherries
Range of
Application
Rates
(Ib ai/A)b
0.005
0.02
0.005
0.01
0.04
0.005
0.01
0.04
Acres Treated
Amount
Handled/
Dayc
40 Gallons
1,000 Gallons
40 Gallons
Baseline5
Dermal
MOEd
140
36
48
24
6
1,700
840
210
Inhalation
MOEe
64
16
23
12
3
2,300
1,200
290
Minimum PPEg
Dermal
MOEd
-
120
67
34
9
-
-
-
Inhalation
MOEe
320
80
120
58
15
-
-
-
Maximum PPEh
Dermal
MOEd
-
-
110
53
13
-
-
-
Inhalation
MOEe
-
160
-
120
29
-
-
-
Engineering
Controls1
Dermal
MOEd
NF
NF
NF
NF
NF
NF
NF
NF
Inhalation
MOEe
NF
NF
NF
NF
NF
NF
NF
NF
Flagger Exposures
Flagging Aerial
Spray Applications
(12)
clover
pineapple
pecans
0.5
2.0
3.0
350
440
110
73
230
57
38
-
-
67
-
290
190
-
-
80
-
-
-
-
-
3,600
-
-
-
Footnotes:
a Crops named are index crops which are chosen to represent all other crops at or near that application rate for that use. See the
application rates listing in the use summary section of this document for further information on application rates used in this
assessment.
b Application Rates are based on the maximum application rates listed on the endosulfan labels.
c Daily amount treated are based on Science Advisory Council for Exposure Policy #9.1.
d Short- term Dermal MOE = Short- term NOAEL ( mg/kg/day)/ Daily Dermal Dose (mg/kg/day).
e Short-term MOE = Short- term NOAEL (mg/kg/day)/ Daily Inhalation Dose (mg/kg/day).
f Baseline clothing: long pants, long sleeved shirt, shoes, socks. Chemical resistant gloves are included for
mixing/loading/applying liquids with a backpack sprayer and wettable powders with a low pressure handwand (scenarios 9 and
11).
g Minimum PPE clothing: Baseline clothing plus dust/mist respirator, and chemical resistant gloves.
h Maximum PPE clothing: Baseline clothing plus organic vapor respirator, double layer of clothes, and chemical resistant gloves.
i Engineering controls: Enclosed mixing/loading, closed cab, truck or cockpit. Baseline level clothing. Chemical resistant gloves
for airblast sprayer application and mixing/loading liquid formulation (scenarios 1 and 5).
Scenario's calculated MOE exceeds the target MOE at the previous level of mitigation. (MOE > 100)
NF = Not feasible for this scenario (no available engineering controls). ND = No data.
Bolded MOE values show a risk of concern at the highest possible level of mitigation for the corresponding scenario.
(2) Post-Application Occupational Risk
The Agency also assessed post-application risks to workers who may be exposed to
endosulfan when they enter previously treated fields, because their skin may contact treated
surfaces. Exposures are directly related to the kind of tasks performed. EPA examines the
amount of pesticide residue workers may be exposed to as the result of performing these tasks.
The Agency evaluates this information to determine the number of days following application
22
-------
that must elapse before the pesticide residues dissipate to a level where worker MOEs equal or
exceed 100 while wearing baseline attire. Baseline attire is defined as long-sleeved shirt, long
pants, coveralls, shoes and socks. Based on the results of the post-application worker
assessment, the Agency establishes REIs before workers may enter treated areas. At present,
endosulfan labels generally have REIs of 24 hours.
The Agency completed a post-application exposure assessment for endosulfan for a
number of scenarios as outlined in Table 9 below. The dermal NOAEL of 12 mg/kg/day based
on a 21-day dermal toxicity study in rats (Table 6) was used to assess potential dermal exposure
to workers re-entering treated fields. The post-application assessment is also based on 8 hours of
daily exposure and the default transfer coefficients (Tcs) shown in Table 9. Also, three
chemical-specific DFR studies were conducted for endosulfan which were used to determine the
values used in conducting the post-application risk assessment.
For post-application risks to endosulfan, an MOE of 100 or greater is not of concern to
the Agency. Table 9 summarizes the occupational post-application risk assessment following
foliar applications of endosulfan. In summary, REIs as high as 30 days are necessary to achieve
an MOE greater than or equal to 100 (e.g. foliar application of the WP on grapes). In general,
post-application risks were higher for the wettable powder formulation versus the emulsifiable
concentrate.
Table 9.
Summary of Post-application Exposure
Crop3
Table Grapes / Raisins
Juice Grapes
Grapes, Table and Juice
Apple, Apricot, Cherry,
Nectarines, Peach, Pear, Plum,
Prune, Christmas Trees,
Ornamental Trees / Shrubs
including Evergreen Trees and
Non-bearing Citrus Trees.
Apple, Apricot, Cherry,
Nectarines, Peach, Pear, Plum,
Prune, Ornamental Trees / Shrubs
including Evergreen Trees, Non-
bearing Citrus Trees, and
Christmas Trees.
Macadamia nuts, Pistachio Nuts,
Pecans, Hazelnut, Almonds
and Walnut
Maximum Label
Application Rate
(Ibs ai/acre)d
WPb
1.5
1.5
1.5
3
3
2
ECC
1.5
1.5
1.5
3
3
3
Transfer
Coefficient6
(cm2/hr)
10,000
5,000
1,000
3 000
1,000
2 500
500
Activity1"
Cane turning and tying, and
girdling
Tying, training, hand
harvesting, hand pruning,
and thinning.
Scouting and irrigating
Thinning, staking, topping,
training, hand harvest, hand
pruning and seed cone
harvesting
Scouting and irrigating
Hand harvesting, pruning,
and thinning
Scouting and irrigating
Application
When MOE
>1008
WPb
30
20
0
5
0
o
0
ECC
6
0
0
o
0
o
0
23
-------
Cropa
Blueberries, Kohlrabi, Broccoli,
and Cabbage.
Kohlrabi, Broccoli, and Cabbage.
Blueberries
Brussels Sprouts and Cauliflower
Corn
Cucumber, Melons, Pumpkin,
Squash, Beans, Peas, Celery,
Lettuce, Spinach, and Carrots.
Alfalfa, Barley , Clover, Oats, Rye,
Wheat, White Potatoes, Cucumber,
Melon, Pumpkin, Squash, Bean,
Peas, Celery, Lettuce, and Spinach.
Carrots
Pepper, Eggplant, and Tomato
Pineapple
Strawberry
Cotton, Collard Greens, Kale,
Mustard Greens, Sweet Potato,
Radish, Rutabaga, and Turnip.
Cotton, Collard Greens, Kale,
Mustard Greens and Sweet Potato.
Radish, Rutabaga, and Turnip.
Tobacco
Maximum Label
Application Rate
(Ibs ai/acre)d
WPb
2
2
2
1
1.5
1
1
1
1
2
2
2
2
2
1.5
ECC
2
2
2
1
1.5
1
1
1
1
2
2
2
2
2
1
Transfer
Coefficient6
(cm2/hr)
5,000
4,000
1,000
5,000
4,000
17,000
1,000
2,500
1,500
300
1,000
700
1000
500
1,500
400
2500
1,500
300
2,000
1,300
Activityf
Hand harvesting, pruning,
thinning, and irrigating.
Scouting and irrigating
Scouting and irrigating
Topping, irrigating, hand
harvesting, and tying.
Scouting and irrigating
Betas sling
Scouting and irrigating
Hand harvesting, pruning,
thinning, turning, and leaf
pulling
Scouting and irrigating
Scouting and irrigating
Hand harvesting, staking,
tying, pruning, thinning,
and training.
Scouting and irrigating
Hand harvesting
Scouting and irrigating
Hand harvesting, pinching,
pruning, and training.
Scouting and irrigating
Hand harvesting, pruning,
and thinning.
Scouting and irrigating
Scouting and irrigating
Hand harvesting, pruning,
striping, thinning, topping,
and hand weeding
Scouting and irrigating
Day after
Application
When MOE
>1008
WPb
14
12
3
9
7
21
1
4
0
0
0
0
3
0
5
0
9
5
0
5
2
ECC
9
7
0
4
2
17
0
0
0
0
0
0
0
0
0
0
3
0
0
0
0
Footnotes:
Day 0 = day of application after sprays have dried (12 hours).
Crops were grouped according to similar application rates, transfer coefficients, and surrogate DFR data sources.
WP = wettable powder formulation
EC = emulsifiable concentrate formulation
maximum application rates as stated on current endosulfan labels.
Transfer Coefficients from Science Advisory Council on Exposure Policy 3.116
Activities are from Science Advisory Council on Exposure Policy 3.1,16 Each activity many not occur for every crop
listed in group.
Day after application when the calculated MOE is greater than the target MOE of 100.
24
-------
(3) Human Health Incident Data
The Agency has reviewed the Incident Data System (IDS), the Poison Control Center, the
California Department of Food and Agriculture (Department of Pesticide Regulation), and the
National Pesticide Telecommunications Network (NPTN) databases for reported incident
information for endosulfan. A number of accidental human poisonings from exposure to
endosulfan in occupational settings have been reported. The data from these sources often
lacked specific information on the extent of exposure and the circumstances of exposure.
Collectively, however, the incidence information indicate definite poisoning risks from misuse of
products that contain endosulfan, or from not wearing personal protective equipment.
Several incidents of acute accidental human exposure to endosulfan have been reported.
The clinical signs and symptoms observed in humans following acute accidental exposure to
endosulfan are similar to those observed in acute toxicity studies in animals. In humans, acute
toxicity caused by endosulfan is characterized by nervousness, agitation, tremors, convulsions,
and death. In one incident, a 70 year old woman died about three hours after she swallowed
"drops" of an endosulfan formulation. Prior to death the woman experienced vomiting, diarrhea,
agitation, tonoclonic convulsions, dyspnea, cyanosis, and loss of consciousness. In one incident,
nine workers experienced at least one convulsion after bagging a 50% wettable powder
formulation of endosulfan. Five of the men were said to be wearing a respirator and protective
clothing at the time of exposure. Prodromal symptoms included malaise, vomiting, dizziness
and confusion. Further, California data show a consistent risk of skin rash or irritation among
field workers who come into substantial contact with endosulfan-treated foliage.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For
detailed discussions of all aspects of the environmental risk assessment, see Final EFED Risk
Assessment for the Reregistration Eligibility Decision on Endosulfan, February 26, 2002,
available in the public docket and on the internet at http://www.epa.gov/pesticides/
reregistration/endosulfan. Major revisions to the ecological risk assessment are listed below:
Some risk estimates were recalculated to reflect supported application rates.
• Some RQs were recalculated to include endosulfan sulfate exposure.
1. Environmental Fate and Transport
Technical grade endosulfan is a mixture of two biologically-active isomers, the alpha (a)
and beta (P) isomers, which differ in physico-chemical and fate properties. Endosulfan is a
persistent, semivolatile compound that has been detected in nearly all environmental
compartments, including water and in areas where it is not used (e.g., the Arctic and national
parks). The end-use product is a mixture of two endosulfan isomers, typically 70% a-
endosulfan and 30% p-endosulfan. The p-isomer is generally more persistent and the a-isomer
25
-------
is more volatile. For both isomers, hydrolysis at pH values greater than 7 is an important
degradation route; however, at pH values below 7, both isomers are rather persistent. At a pH of
7, a-endosulfan and P-endosulfan hydrolyze with half-lives of 11 and 19 days, respectively, and
at a pH of 9, the isomers have half-lives of 4 to 6 hours. Under acidic conditions, both isomers
are stable to hydrolysis, and microbial degradation in soils becomes the predominant route of
degradation. Half-lives in acidic to neutral soils range from one to two months for a-endosulfan
and from three to nine months for P-endosulfan under aerobic conditions. Dissipation rates
observed in the field studies, which capture a combination of degradation, transport, and uptake,
suggest that endosulfan will persist in the surface soil for weeks to months after application
(similar order of magnitude to rates observed in the soil metabolism studies).
The major transformation products found in the fate studies are endosulfan diol
(hydrolysis) and endosulfan sulfate (soil metabolism). Both the diol and sulfate transformation
products have structures similar to the parent compound and are also of toxicological concern.
Available data suggest that endosulfan sulfate will be more persistent than the parent. The
estimated half-lives for the combined toxic residues (endosulfan plus endosulfan sulfate) ranged
from roughly 9 months to 6 years.
Laboratory studies indicate that a- and P-endosulfan have a high affinity for sorption
onto soils. The average organic carbon partition coefficients (Koc) were 10,600 and 13,600
mL/g, for the a- and (3-endosulfan isomers, respectively. These isomers are not expected to be
highly mobile in the soil environments; therefore, they should not be frequently detected in
ground water; however, due to their persistence, vulnerable aquifers below acidic soils could be
prone to contamination. Moreover, horizontal transport is possible via erosion or dissolution in
runoff events. Endosulfan can also contaminate surface waters through spray drift. Its high
affinity to sorb to soil indicates that endosulfan is likely to be associated predominantly with the
sediment phase in runoff. Endosulfan reaching the water column, through spray drift or runoff,
will have a propensity to sorb to benthic sediment, and this sediment may eventually become a
source of endosulfan redistribution into the overlying waters. Endosulfan may move beyond its
use area through atmospheric transport (via volatilization and/or transport in dust particles).
Based on environmental fate laboratory studies, terrestrial field dissipation studies,
available models, monitoring studies, and published literature, it can be concluded that
endosulfan is a very persistent chemical which may stay in the environment for lengthy periods
of time, particularly in acid media. Endosulfan may be transported via dissolution in water/via
runoff, adsorption to soil particles/via erosion, vaporization and/or adsorption to dust
particles/transport in the air. While atmospheric transport has been documented for endosulfan,
the available data is not sufficient to evaluate its potential impacts on non-target organisms. The
limited data available show measured concentrations significantly lower than those used in the
Agency's risk assessment but exposures to more sensitive species are possible.
Endosulfan has a relatively high potential to bioaccumulate in fish with octanol-water
partition coefficients (Kow) of 55,500 for a endosulfan and 61,400 for P endosulfan. Studies
suggest that endosulfan bioconcentration factors in fish ranged from 2400X to 11,OOOX for
26
-------
combined isomers in whole fish and endosulfan depurated after 24 hours. Rates of depuration in
field conditions will depend on the levels of endosulfan in the water column and the length of
time those levels are maintained. Studies have revealed tissue residues are composed of both
parent and the endosulfan sulfate degradate.
2.
Risk to Birds and Mammals
The Agency's ecological risk assessment compares toxicity endpoints from ecological
studies to estimated environmental concentrations (EECs) based on environmental fate
characteristics and pesticide use data. To evaluate the potential risk to nontarget organisms from
the use of endosulfan products, the Agency calculates a Risk Quotient (RQ), which is the ratio of
the EEC to the toxicity endpoint values, such as the median lethal dose (LD50) or the median
lethal concentration (LC50). These RQ values are then compared to the Agency's levels of
concern (LOCs) which indicates whether a chemical, when used as directed, has the potential to
cause adverse effects on nontarget organisms. In general, the higher the RQ the greater the
concern. When the RQ exceeds the LOG for a particular category (e.g. endangered species), the
Agency presumes a risk of concern to that category. The LOCs and the corresponding risk
presumptions are presented in Table 10. In addition, the Agency has conducted a more refined,
probabilistic assessment for aquatic organisms.
Table 10. LOCs and Associated Risk Presumptions
IF...
THEN the Agency presumes...
Mammals and Birds
The acute RQ > LOG of 0.5,
The acute RQ >LOC of 0.2,
The acute RQ > LOG of 0. 1,
The chronic RQ > LOG of 1
Acute risk
Risk that may be mitigated through restricted use
Acute effects may occur in Endangered species
Chronic risk and Chronic effects may occur in Endangered species
Fish and Aquatic Invertebrates
The acute RQ > LOG of 0.5
The acute RQ > LOG of 0. 1
The acute RQ >LOC of 0.05
The chronic RQ > LOG of 1
Acute risk
Risk that may be mitigated through restricted use
Acute effects may occur in Endangered species
Chronic risk and Chronic effects may occur in Endangered species
a. Toxicity (Hazard) Assessment
Endosulfan is classified as highly toxic to birds and mammals on an acute exposure basis
and moderately toxic to birds on a subacute dietary basis. Chronic toxicity data on birds and
mammals revealed that reproduction and growth were the most sensitive endpoints. For birds, at
60 ppm there were significant reductions in the number of eggs laid, number of eggs hatched,
adult body weight and feed consumption. In rats, there was an increase in cumulative pup loss
and a reduction in litter size at 100 ppm; parental systemic toxicity was based on decreased body
weight and offspring toxicity was based on increased pituitary and uterine weights.
27
-------
The acute and chronic toxicity endpoints for endosulfan are presented in Table 11.
Information in the literature has indicated that in birds, endosulfan may impair the development
of the genital tract. In mammals, reduced hormone levels, testicular atrophy and reduced sperm
production were observed. These data suggest that endosulfan may affect endocrine-mediated
pathways.
Table 11. Summary of Acute and Chronic Toxicity Data for Terrestrial Organisms
Species
Northern bobwhite quail
(Colinus virginianus)
Mallard duck (Anas platyrhynchos)
Honey bee (Apis meliferus)
Laboratory rat (Rattus norvegicus)
Acute Toxicity
LD50
(ppm)
--
28
4.5
10
Acute Oral
Toxicity
--
highly toxic
-
highly toxic
5-day LC50
(ppm)
805
1053
--
--
Subacute Dietary
Toxicity
moderately toxic
slightly toxic
--
--
Chronic Toxicity
NOEC/LOEC
(ppm)
60 / 120
30/60
--
15/75
Affected Endpoints
reproduction
reproduction and growth
--
growth
3. Exposure and Risk
The Agency's ecological risk assessment for terrestrial wildlife considers exposure to
endosulfan from the ingestion of residues on food. Terrestrial estimated environmental
concentrations (EECs) were derived for major crops using labeled application rates and intervals
between applications. Uncertainties in the terrestrial EECs are primarily associated with a lack
of data on interception and subsequent dissipation from foliar surfaces. Exposure estimates for
terrestrial animals represent parent endosulfan only and do not take into account residues from
the more persistent and assumed to be equally toxic endosulfan sulfate.
Acute high risk, restricted use and endangered species LOCs are exceeded for birds (RQ
range: 0.02 - 0.53) and mammals (RQ range: 0.05 - 40) at current application rates for the major
crops modeled. Chronic LOCs for birds were exceeded (RQ range: 0.03 - 2.7) following both
single and multiple applications on all food items except seeds. Chronic LOCs for mammals
were exceeded (RQ range: 0.3 - 5.4) following multiple applications on all food items. Tables
12-14 summarize the risk quotients for terrestrial wildlife.
Table 12. Avian Acute and Chronic Risk Quotients
Use/App.
Method
Rate (Ibs ai/A) x No.
Apps. (Interval,
days)
Food Items
Max. EEC
(mg/kg)
Avg. EEC
(mg/kg)
Acute RQ
Chronic
RQ
Single Application
tobacco, tomatoes,
potatoes, lettuce
(aerial), cantaloupe
(ground)
1 Ib./A (1)
Short grass
Tall grass
Broadleaf plants/Insects
Seeds
240
110
135
15
27
10
11
1
0.30
0.14
0.17
0.02
0.9
0.3
0.4
0.03
Multiple Applications
tobacco (aerial),
tomatoes (aerial),
cantaloupe (ground)
1 Ib./A (3)
7 -day interval
Short grass
Tall grass
Broadleaf plants/Insects
Seeds
332
152
187
21
81
35
41
4
0.41
0.19
0.23
0.03
2.7
1.2
1.4
0.1
28
-------
Use/App.
Method
Apples (air blast),
grapes (aerial),
pecans (air blast)
Rate (Ibs ai/A) x No.
Apps. (Interval,
days)
1.51bs./A(2)
10 -day interval
Food Items
Short grass
Tall grass
Broadleaf plants/Insects
Seeds
Max. EEC
(mg/kg)
424
194
238
26
Avg. EEC
(mg/kg)
81
34
39
4
Acute RQ
0.53
0.24
0.30
0.03
Chronic
RQ
2.7
1.1
1.3
0.13
Table 13. Acute RQ Values for Small (15 g), Intermediate (35 g) and Large (1,000 g)
Mammals Feeding on Short or Tall Grass, Broadleaf Plants/insects, and
Seeds
Site (method)
Application Rate
(number of applications)
tobacco, lettuce, tomatoes potatoes
(aerial), cantaloupe (ground)
1 Ib a.i./A
tobacco (aerial), tomatoes (aerial),
cantaloupe (ground)
1 Ib. a.i./A (3)
apples (air blast), grapes (aerial), pecans
(air blast)
1.5 Ibs. a.i./A (2)
Body Weight
(grams)
15
35
1000
15
35
1000
15
35
1000
RQ
Short Grass
23
16
3.6
32
22
5
40
28
6.3
RQ
Tall Grass
10
7.2
1.6
14
10
2.3
18
13
2.9
RQ
Broadleaf
Plants/Insects
13
8.9
2.0
18
12
2.8
23
16
3.6
RQ
Seeds
0.32
0.22
0.05
0.44
0.31
0.06
0.55
0.39
0.08
Table 14. Chronic RQ Values for Mammals Feeding on Short Grass, Tall Grass,
Broadleaf Plants/insects, and Seeds Exposed to Endosulfan Following
Multiple Applications
Site (method) Application Rate
(number of applications)
tobacco (aerial), tomatoes (aerial), cantaloupe
(ground) 1 Ib. a.i./A (3)
apples (air blast), grapes (aerial), pecans (air
blast) 1.5 Ibs. a.i./A (2)
RQ
Short Grass
4.4
5.4
RQ
Tall Grass
2.3
2.3
RQ
Broadleaf Plants/Insects
2.7
2.6
RQ
Seeds
0.3
0.3
4. Risk to Aquatic Species
a. Toxicity (Hazard) Assessment
Endosulfan is very highly toxic to freshwater and estuarine/marine fish and invertebrates.
Table 15 summarizes the most sensitive endpoints used in the hazard assessment of aquatic
animals. Acute aquatic toxicity estimates ranged from 0.1 to 166 ppb for endosulfan.
Estuarine/marine organisms generally were more sensitive to the effects of endosulfan than their
freshwater counterparts. No chronic toxicity data were available for the most sensitive
freshwater species (rainbow trout and scuds) thus acute to chronic ratio (0.1) was used to predict
29
-------
NOEC values for these species. On species where chronic toxicity data were available, the most
sensitive endpoints were reduced growth and survival. Information from the open literature has
indicated that amphibians exposed to endosulfan exhibited impaired development of tadpoles
into adults. In fish, endosulfan treatment has resulted in the reduction of cortisol secretion by
head kidney cells. These data suggest that endosulfan may affect endocrine-mediated pathways.
Available acute toxicity data include an EC50 of 0.58 mg/L for endosulfan diol on
Daphnia magna, indicating that this intermediate degradate is highly toxic to freshwater
invertebrates. Acute toxicity testing of endosulfan sulfate (fish LC50 = 2.2 ppb; daphnid EC50 =
580 ppb) indicates the toxicity of the persistent degradate is comparable to that of technical
grade parent.
Table 15. Summary of Acute and Chronic Aquatic Toxicity Estimates
Species
Rainbow trout Oncorhychus mykiss
Bluegill sunfish Lepomis macrochirus
Fathead minnows Pimephales promelas
Scud Gammums lacustris
Water flea Daphnia magna
Striped bass Momone saxatillis
Eastern oyster Crassostrea virginica
Grass shrimp
Acute Toxicity
96-hr LC50
(ppb)
0.8
1.7
1.5
--
--
0.1
0.45
1.3
48-hr EC50
(ppb)
-
-
-
6
166
-
-
-
Acute Toxicity
very highly toxic
very highly toxic
very highly toxic
very highly toxic
very highly toxic
very highly toxic
very highly toxic
very highly toxic
Chronic Toxicity
NOEC/LOEC
(ppb)
NOEC = 0.r
-
NOEC = 0.2
LOEC= 0.4
NOEC = 0.07
NOEC = 2
LOEC < 7
o.or
0.05a
-
Affected
Endpoints
-
-
Reduced growth
and survival
-
reduced survival
-
-
-
a chronic value predicted using acute to chronic ratio of 0.1 estimated from fathead minnow data (acute =1.5 ppb; chronic = 0.2
ppb)
b. Exposure and Risk
To assess potential risk to aquatic animals, the Agency uses a computer model to
generate EECs of endosulfan in surface water. However, unlike the drinking water assessment
described in the human health risk assessment section of this document, the ecological water
resource assessment does not include the index reservoir and percent crop area factor. These
refinements are solely used to assess pesticide exposure to humans from drinking water sources
since they are used to predict the levels of endosulfan in a drinking water reservoir from use of
endosulfan throughout a watershed rather than predicting the potential exposure to non-target
organisms at the field level. Hence, the EECs used to assess exposure to aquatic animals are not
the same as the EEC values used to assess human dietary exposure from drinking water sources.
Peak EECs were compared to acute toxicity endpoints to derive acute risk quotients and
21-day EECs were compared to chronic toxicity endpoints (NOAEC) to derive chronic risk
quotients for freshwater and estuarine/marine organisms. Exposure estimates for aquatic animals
30
-------
represent parent endosulfan and residues from the more persistent and equally toxic endosulfan
sulfate.
At the current maximum application rates used on the major crops where endosulfan is
employed, coupled with a 300-ft spray drift buffer, acute high risk, restricted use and
endangered species levels of concern are exceeded for both freshwater and estuarine/marine
organisms. Acute RQ values ranged from 1.04 to 34.8 for freshwater fish and from 0.15 to 5 for
freshwater invertebrates. Estuarine/marine fish and invertebrates were roughly an order of
magnitude more sensitive to the effects of endosulfan, with acute RQ values ranging from 8.7 to
289 for fish and 1.9 to 64.2 for invertebrates. Chronic RQ values ranged from 1.5 to 64 for
freshwater fish and from 3.6 to 135.3 for freshwater invertebrates. Chronic RQ values for
estuarine ranged from 16 to 704 for fish and 1 to 39.5 for invertebrates.
The following tables summarize the RQs for aquatic organisms using maximum labeled
rates and accounting for the 300-foot spray drift buffer. Some sections of the tables do not
contain entries either because chronic exposures are not compared against acute toxicity, acute
exposures are not compared against chronic toxicity, 21-day exposure are not compared against
56-day toxicity value or 56-day exposure not compared against 21-day toxicity value.
Table 16. Acute and Chronic Risk Quotients for Freshwater Fish and Invertebrates
Crop Application
Rate (# of apps)
Apples
1.5(2)
Cotton
1.5(2)
Lettuce
1.0(3)
Pecan
1.5(2)
Potato
1.0(3)
Tobacco
1.0(3)
Tomato
1.0(3)
EECs
Peak/
21 -day Average
56-day Average
(ppb)
0.87
0.25
0.16
11.67
4.9
3.89
4.64
1.41
0.79
19.39
6
3.86
6.07
2.14
1.53
9.72
2.8
1.72
28.9
9.47
7.04
Acute Risk Quotients
Freshwater Fish
LC50 = 0.83 ppb
1.04
14.1
5.6
23.4
7.3
11.7
34.8
Freshwater
Invertebrate
LC50 = 5.8 ppb
0.15
2
0.8
3.4
1.1
1.7
5
Chronic Risk Quotients
Freshwater Fish
NOEC = 0.11
(ppb)
1.5
35.4
7.2
35.1
13.9
15.6
64
Freshwater
Invertebrate
NOEC = 0.07
(ppb)
3.6
70
20.1
85.7
30.6
40
135.3
-------
Table 17. Acute and Chronic Risk Quotients for Estuarine/marine Fish and
Invertebrates
Crop Application
Rate (# of apps)
Apples
1.5(2)
Cotton
1.5(2)
Lettuce
1.0(1)
Pecan
1.5(2)
Potato
1.0(3)
Tobacco
1.0(3)
Tomato
1.0(3)
EECs
Peak
21-day Average
(Ppb)
0.87
0.25
0.16
11.67
4.9
3.89
4.64
1.41
0.79
19.39
6
3.86
6.07
2.14
1.53
9.72
2.8
1.72
28.9
9.47
7.04
Acute Risk Quotients
E stuarine/marine
Fish
LC50 = 0.1 ppb
(EEC/LC50)
8.7
116.7
46.4
193.9
60.7
97.2
289
Estuarine/marine
Invertebrate
LC50 = 0.45 (ppb)
(EEC/LC50)
1.9
25.9
10.3
43.1
13.5
21.6
64.2
Chronic Risk Quotients
Estuarine/marine
Fish
NOEC = 0.01
(ppb)
(EEC/NOEC)
16
389
79
386
153
172
704
E stuarine/marine
Invertebrate
NOEC = 0.24
(Ppb)
(EEC/NOEC)
1
20.4
5.87
25
8.9
7.2
39.5
Endosulfan was the most frequently detected insecticide in tadpole and adult frog tissues
in a California study (Sparling et. al. 2001). The frequency of occurrence of endosulfan was
higher in samples collected in the Sierra Nevada mountains east of the Central Valley.
Concentrations and frequency of detections for the pesticide in amphibian tissue follow north-
south and west-east patterns consistent with intensified agriculture upwind of the areas with the
most serious declines in amphibian populations, several of which are either listed (red-legged
frog [Rana aurora]) or proposed for listing (yellow-legged frog [Rana muscosa] and Yosemite
toad \Bufo canorus]) as threatened under the Endangered Species Act.
5.
Probabilistic Assessment
The Agency used probabilistic assessment techniques to conduct a more refined risk
assessment for aquatic organisms that was based on actual reported application rates in
California coupled with a 300-ft spray-drift buffer. The methods used in this assessment and
other probabilistic methods are currently under development, and thus this assessment is not
definitive and further refinements in the techniques should be expected. However, this
assessment does provide some insight into the expected effects of endosulfan on whole aquatic
systems.
32
-------
This assessment compared a range of EEC values (single annual 96-hour maximum
concentrations) from models to a range of LC50 values for several aquatic species. This analysis
provides a first step into probabilistically modeling of overall aquatic effects and provides
insights on the range of endosulfan's ecological effects. The assessment estimates that, for the
lowest exposure uses (e.g., apples), the use of endosulfan at typical application rates has a 10%
probability of detrimentally affecting (LC50 values being exceeded by modeled EECs) 10% of
the aquatic species in a given year. For higher exposure uses (e.g., tomatoes) the use of
endosulfan at typical application rates in a given year resulted in a 90% probability that 60% of
the aquatic species will be detrimentally affected, a 50% probability that 75% of the species will
be detrimentally affected, and a 10% probability that 90% of the species will be detrimentally
affected.
6. Risks to Endangered Species
Endangered species LOCs are exceeded for acute and chronic risks to all taxa fo
endangered/threatened animals - birds, mammals, fish, aquatic invertebrates, amphibians,
reptiles and terrestrial for all currently registered uses of endosulfan.
In 1989 the U.S. Fish and Wildlife Service (USFWS) issued a biological opinion on
endosulfan in response to the U. S. Environmental Protection Agency's request for consultation.
In issuing its opinion the USFWS considered the following factors: (1) potential for exposure of
the listed species to the pesticide; (2) information on the chemical toxicity relative to estimated
environmental concentrations; (3) potential for secondary impacts; and (4) special concerns not
specifically addressed in the preceding factors or unique to the situation being evaluated. Given
the evaluation criteria, a total of 130 species (6 amphibians, 77 fish, 32 mussels, 6 crustaceans, 4
miscellaneous aquatic invertebrates, and 5 bird species) were considered potentially affected by
the use of endosulfan. Of those organisms potentially affected, the USFWS listed 41 aquatic
species as jeopardized, of which the majority (54%) were endangered/threatened species of
freshwater mussels. Two terrestrial (avian) species were also classified as being in jeopardy.
The remaining potentially affected organisms were listed either as having no potential for
exposure or as not being in jeopardy.
The Agency's current assessment of ecological risks uses both more refined methods to
define ecological risks of pesticides and new data, such as that for spray drift. Therefore, the
Reasonable and Prudent Alternatives and Reasonable and Prudent Measures in the Biological
Opinion may need to be reassessed and modified based on these new approaches.
The Agency is currently engaged in a Proactive Conservation Review with FWS and the
National Marine Fisheries Service under section 7(a)(l) of the Endangered Species Act. The
objective of this review is to clarify and develop consistent processes for endangered species risk
assessments and consultations. Subsequent to the completion of this process, the Agency will
reassess the potential effects of endosulfan use to federally listed threatened and endangered
species. At that time the Agency will also consider any regulatory changes recommended in the
RED that are being implemented. Until such time as this analysis is completed, the overall
33
-------
environmental effects mitigation strategy articulated in this document and any County Specific
Pamphlets which address endosulfan, will serve as interim protection measures to reduce the
likelihood that endangered and threatened species may be exposed to endosulfan at levels of
concern.
7. Ecological Incident Reports
A review of the Ecological Incident Information System revealed that since 1971 a total
of 91 incidents have been associated with the use of endosulfan. The majority of incidents
occurred in California, South Carolina, North Carolina, and Louisiana. The overwhelming
majority (96%) of the incidents were associated with the aquatic environment: 82% affected fish
while 7% affected aquatic macroinvertebrates. The database indicates that 34% of the
endosulfan incidents were a result of either accidental or intentional misuse of the pesticide, 29%
resulted from the labeled use of endosulfan and the rest were unspecified. Approximately 32%
of the incidents were directly attributable to runoff. However, weather conditions were not
specified in the majority of cases, so the contribution of runoff may be underestimated by the
reported results.
According to the National Oceanic and Atmospheric Agency's fish-kill database
endosulfan was responsible for more fish kills in U.S. estuaries and coastal rivers between 1980
and 1989 than all currently used pesticides at that time. The report noted that endosulfan was
one of the most often found of the inventoried pesticides in aquatic biota and in one case affected
estuarine biomass.
In 1991, as mentioned earlier, a 300-foot spray drift buffer was put in place on
endosulfan labels to address contamination of water bodies. Since this restriction was
implemented in 1991 a total of 33 aquatic incidents have been reported, 20 of which were not
attributed to misuse. In terms Of these 20 incidents, 7 have been classified as highly probable,
11 have been classified as probable and 3 have been classified as possible. Thus, despite use
restrictions to limit degradation of the aquatic environment, endosulfan has continued to access
the aquatic environment and result in nontarget mortality.
8. Endocrine Disruption
Exposure to endosulfan has resulted in both reproductive and developmental effects in
nontarget animals. Endosulfan exposure resulted in impaired development in amphibians,
reduced cortisol secretion in fish, impaired development of the genital tract in birds and reduced
hormone levels and sperm production and produced testicular atrophy in mammals.
Additionally, endosulfan has been demonstrated to bind to the human estrogen receptor and
exhibit significant estrogenic activity. Whether the toxicity endpoints are a result of endocrine
disruption is not known. However, it is clear that organisms treated with endosulfan did exhibit
some toxic effects that have historically been associated with endocrine disrupting chemicals,
e.g., developmental and reproductive effects.
34
-------
9. Long Range Transport
Endosulfan is a semivolatile and persistent cyclodiene pesticide that can migrate over a
long distance through various environmental media such as air, water, and sediment. Once
endosulfan is applied to crops, it can either persist in soil as a sorbed phase or be removed
through several physical, chemical, and biological processes. Recent studies suggest that
secondary emissions of residual endosulfan continue to recycle in the global system while they
slowly migrated and were redeposited via wet deposition in the Northern Hemisphere. The
occurrence of endosulfan in remote regions like the Great Lakes, the Arctic, and mountainous
areas is well documented. Endosulfan can also enter the air as adsorbed phase onto suspended
particulate matter, but this process does not appear to be a major contributor long range transport
like volatilization.
The presence of endosulfan in the remote areas like Arctic and the Great Lakes requires
further understanding of the transport mechanisms from the atmosphere. The potential impact of
atmospheric deposition of endosulfan into surface water and its potential effect on water quality
and aquatic organisms in the non-use areas is not well documented. Despite the progress made
in recent years in estimating the persistence and long-ranged transport of chemicals using
models, a validated global model has not been published because of uncertainties involved in the
source inventories, chemical fate data, degradative pathways and exposure analyses. Future
work will be aimed at developing a comprehensive screening tool that can be used reliably in
risk assessments for regulatory purposes.
IV. Risk Management and Reregistration Decision
A. Determination of Reregistration 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 ingredient
are eligible for reregistration. The Agency has previously identified and required the submission
of the generic (i.e., an active ingredient specific) data required to support reregistration of
products containing endosulfan active ingredients.
The Agency has completed its assessment of the dietary (food and drinking water),
ecological and occupational risks associated with the use of currently registered pesticides
containing the active ingredient endosulfan. Based on a review of these data and public
comments on the Agency's assessments for the active ingredient endosulfan, EPA has sufficient
information on the human health and ecological effects of endosulfan to make decisions as part
of the tolerance reassessment process under FFDCA and reregistration under FIFRA, as
amended by FQPA. The Agency has reassessed all 80 tolerances for endosulfan and can make a
FQPA safety determination as detailed below. The Agency has determined that agricultural use
of endosulfan, based on the currently approved labeling, pose occupational and ecological risks
that constitute unreasonable adverse effects on the environment. However, the Agency believes
35
-------
that these risks can likely be acceptably mitigated through routine changes to pesticide labeling
and formulations. Accordingly, the Agency has determined that endosulfan is eligible for
reregi strati on provided that: (i) additional data that the Agency intends to require confirm this
decision for occupational exposures associated with the application of dip treatment to roots or
whole plants and ecological risks; and (ii) the risk mitigation measures outlined in this document
are adopted, and label amendments are made to reflect these measures. Label changes are
described in Section V of this document. Appendix A summarizes the uses of endosulfan that
would be eligible for reregi strati on. Appendix B identifies the generic data requirements that the
Agency reviewed as part of its determination of reregi strati on eligibility of endosulfan, and lists
the submitted studies that the Agency found acceptable. The additional data that the Agency
intends to require are described in Section V. Further mitigation measures and additional data
requirements, however, may be warranted following the completion of the stakeholder process
outlined in this document.
Based on its evaluation of endosulfan, the Agency has determined that endosulfan
products, unless labeled and used as specified in this document, would present risks inconsistent
with FIFRA. Accordingly, should a registrant fail to implement any of the risk mitigation
measures identified in this document, the Agency may take regulatory action to address the risk
concerns from use of endosulfan.
B. Phase 3 Comments and Responses
When making its reregi strati on decision, the Agency took into account all comments
received during Phases 3, 4 and 5 of the Public Participation Process. These comments in their
entirety are available in the docket. Comments, which addressed human health and ecological
concerns, were received from the technical registrants, represented by the Endosulfan Task
Force(ETF), environmental and advocacy groups such as the Natural Resources Defense Council
(NRDC), the Farmworker Justice Fund, Inc., the Pesticide Action Network North America
(PANNA) and their affiliate, the Pesticide Action Network Asia and Pacific (PANAP),
Respiratory and Environmental Disabilities Association of Hawaii, the Rural Action Safe Pest
Control Program (RASPCP), the World Wildlife Federation, and private citizens. Agency
responses to comments are available on the Agency's web page:
http://www. epa.gov/pesticides/reregistration/endosulfan.
Comment Period on this RED
The Agency is providing a 60-day comment period on this RED. While all comments are
welcome, those with specific data or information bearing on the risk and benefit assessments are
most useful. For example, the Agency is aware that cotton stakeholders are gathering data on the
number of acres treated per day by air in AZ and CA which may be used to characterize handler
risks in those areas and may impact the maximum application rate allowed for that crop. The
Agency has also recently received comments related to tobacco which will be considered during
the comment period.
36
-------
C. Regulatory Position
1. FQPA Assessment
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with this pesticide. EPA has determined that risk from exposure to endosulfan exceeds its own
"risk cup" for pesticidal uses of endosulfan registered by EPA. However, if the use of
endosulfan on succulent beans, succulent peas, grapes, pecans and spinach are deleted and the
mitigation measures in this document to prevent contamination of surface waters are
implemented, the Agency believes that endosulfan will "fit" within its risk cup. Therefore, the
Agency has concluded that the tolerances for endosulfan meet the FQPA safety standards,
provided the risk mitigation measures outlined in this document are adopted. In reaching this
determination, EPA has considered the available information on the special sensitivity of infants
and children, as well as the acute and chronic food exposure. An aggregate assessment was
conducted for exposures resulting from food and drinking water for pesticidal uses of endosulfan
registered by EPA under FIFRA. Results of this aggregate assessment indicate that the human
health risks from these combined exposures are considered to be over acceptable levels, but that
the combined risks from all exposures to endosulfan do "fit" within the individual risk cup
provided the risk mitigation contained in this decision document are fully implemented.
b. Tolerance Summary
Tolerances for residues of endosulfan in/on plant and animal commodities are established
under 40 CFR §180.182. Tolerances for residues of endosulfan in processed commodities are
established under 40 CFR §185.2600. Endosulfan tolerances are currently expressed in terms of
the total residues of endosulfan (6,7,8,9,10,10-hexachloro-l,5,5a,6,9,9a-hexahydro-6,9-methano-
2,4,3-benzodioxathiepin-3-oxide) and its metabolite, endosulfan sulfate (6,7,8,9,10,10-
hexachloro-l,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin-3,3-dioxide). The
current endosulfan tolerance expression does not specify the two stereo isomers of the parent
compound.
The Agency has determined that tolerances for crop and livestock commodities should
continue to be expressed as residues of the parent (a and |3 isomers) and the sulfate metabolite.
However, the Agency recommends that the tolerance expression be revised in order to specify
the a and |3 isomers of the parent.
The Agency has recently updated the list of raw agricultural and processed commodities
and feedstuffs derived from crops (Table 1, OPPTS GLN 860.1000). As a result of changes to
Table 1, endosulfan tolerances for certain commodities which have been removed from Table 1
need to be revoked, and some commodity definitions must be corrected. In addition, tolerances
for commodities for which there are currently no registered uses of endosulfan need to be
revoked. A summary of endosulfan tolerance reassessments is presented in Table 18.
37
-------
Tolerances Listed Under 40 CFR §180.182:
Pending label revisions for some crops, sufficient field trial data have been submitted (or
were translated when appropriate) to reassess the established tolerances for the following plant
commodities, as defined: almonds; almonds, hulls; apples; apricots; beans; blueberries; broccoli;
Brussels sprouts; cabbage; carrots; cauliflower; celery; cherries; collards; corn, sweet
(K+CWHR); cottonseed; cotton gin byproducts; cucumbers; eggplant; filberts; grapes; kale;
lettuce; macadamia nuts; melons; mustard greens; nectarines; peaches; pears; peas, pistachios,
succulent; pecans; peppers; pineapples; plums; potatoes; prunes; pumpkins; spinach; squash,
summer; squash, winter; strawberries; sweet potatoes; tomatoes; turnips; and walnuts.
Additional data is needed for the uses of endosulfan on wheat, oats, rye, and barley.
The available residue data suggest that the established tolerance levels for the following
plant commodities should be decreased from 2.0 to 1.0 ppm: apples; cucumbers; eggplant;
melons; pineapples; pumpkins; squash, summer; squash, winter; and tomatoes. The Agency
proposes a crop group tolerance for Cucurbit Vegetables Group (Crop Group 9) since adequate
data are available for cucumbers, melons, and squash which are the representative commodities
of this crop group.
The available residue data suggest that the established tolerance levels for the following
commodities should be increased: broccoli (from 2.0 to 3.0 ppm); cabbage (from 2.0 to 4.0
ppm); celery (from 2.0 to 8.0 ppm); lettuce, head (from 2.0 to 11.0 ppm); and lettuce, leaf (from
2.0 to 6.0 ppm); Blueberry (from 0.1 to 0.3 ppm); barley grain (from 0.1 to 0.3 ppm); and barley
straw (from 0.2 to 0.4); rye grain (from 0.1 to 0.3); and rye straw (from 0.2 to 0.3 ppm); oats
grain (from (0.1 to 0.3); and oats straw (from 0.2 to 0.4 ppm); and oats grain (from 0.1 to 0.3);
and wheat straw (from 0.2 to 0.4 ppm).
The expected dietary burdens of endosulfan to beef and dairy cattle were re-calculated
following tolerance reassessment of livestock feed items. Livestock feeding studies reflecting
the re-calculated dietary burden are available. Following evaluation of feeding data, the Agency
concluded: (I) the tolerance for milk fat (=N in whole milk) at 0.5 ppm should be increased to
2.0 ppm; (ii) the tolerances for meat byproducts of cattle, goats, hogs, horses, and sheep at 0.2
ppm should be replaced with separate tolerances for meat byproducts (except liver) at 1.0 ppm
and liver at 5.0 ppm; and (iii) the tolerance for fat should be increased from 0.2 to 13 ppm.
The available poultry feeding data suggest that it is not possible to establish with
certainty whether finite residues of endosulfan will be incurred, but there is no reasonable
expectation of finite residues (Category 3 of 40 CFR §180.6). Therefore, tolerances are not
required for eggs and poultry tissues.
Tolerance to be Proposed Under 40 CFR §180.182:
Tolerances for the combined residues of endosulfan (a and |3 isomers) and its metabolite
endosulfan sulfate in/on: pearled barley, barley hay, flour, and bran; oats forage, hay, flour and
38
-------
rolled oats; rye forage, flour and bran; wheat forage, hay, and aspirated grain fractions must be
proposed once adequate field residue data, reflecting the maximum registered use patterns, have
been submitted and evaluated.
The apple processing study indicates that the combined residues of endosulfan (a and |3
isomers) and endosulfan sulfate concentrated in dried and wet apple pomace (17x and 6x,
respectively); no concentration of endosulfan residues was observed in apple juice. A tolerance
for dried apple pomace is not required as it is no longer considered a major livestock feed item
and its entry has been deleted from Table 1. A tolerance for apple juice is also not warranted.
However, based on the highest average field trial combined residues in/on the RAC and a
concentration factor of 6x, the maximum expected endosulfan residues in wet apple pomace is
4.62 ppm. Therefore, a tolerance for the combined endosulfan residues in wet apple pomace
must be proposed at 5.0 ppm.
The pineapple processing study indicates that the combined residues of endosulfan (a
and |3 isomers) and endosulfan sulfate concentrated up to 7x in peel and 41x in bran processed
from whole pineapples bearing detectable endosulfan residues; no concentration of endosulfan
residues was observed in pineapple pulp and juice. According to OPPTS Table 1, residue data
are only required for process residue and juice. Pineapple process residue (also known as wet
bran) is a waste byproduct from the fresh-cut product line that includes pineapple tops (minus
crown), bottoms, peels, any trimmings with peel cut up, and the pulp (left after squeezing for
juice). Based on a HAFT combined endosulfan residues of 0.44 ppm in/on the RAC and a
concentration factor of 41x, the maximum expected total endosulfan residues in pineapple
process residue is 18.04 ppm. Therefore, a tolerance for the combined endosulfan residues in
pineapple process residue must be proposed at 20 ppm. A tolerance for pineapple juice is not
warranted.
The available tomato processing data indicate that endosulfan residues of concern
marginally concentrate (1.2x) in tomato paste processed from treated tomatoes. The
concentration of residues in tomato paste is not significant enough to warrant a tolerance for this
commodity. A tolerance for tomato puree is also not warranted. Processing data for oats, barley,
wheat, and rye are required.
Tolerance Listed Under 40 CFR §185.2600:
Adequate data are available to reassess the established tolerance for dried tea leaves. The
established tolerance for dried tea (reflecting less than 0.1 ppm residues in beverage tea) listed
under 40 CFR §185.2600 should be moved to 40 CFR 180.182 because the enacted FQPA
stipulates that tolerances for pesticide residues in all types of food (raw or processed) be set
under the same provisions of the law.
39
-------
Pending Tolerance Petition:
Hoechst Celanese Corporation proposed the establishment of tolerances for residues of
endosulfan and endosulfan sulfate in dried hops and spent hops imported from Germany, each at
10 ppm. The Agency recommends in favor of the proposed tolerances subject to the registrant
limiting the number of applications to three.
Table 18. Tolerance Reassessment Summary for Endosulfan
Commodity
Established
Tolerance
(ppm)
Reassessed
Tolerance
(ppm)
Comments
[Correct Commodity Definition]
Tolerance Listed Under 40 CFR §180.182 (a) (1)
Alfalfa, fresh
Alfalfa, hay
Almond
Almond, hulls
Apple
Apricot
Artichoke, globe
Barley, grain
Barley, straw
Bean
Beets, sugar, without
tops
0.3
1.0
0.2 (N)*
1.0
2.0
2.0
2.0
0.1 (N)
0.2 (N)
2.0
0.1 (N)
Revoke
Revoke
0.3
1.0
1.0
2.0
Revoke
0.3
0.4
2.0 (Bean,
dry and
succulent)
Revoke
No longer a registered use.
The available data indicate that residues of endosulfan or
endosulfan sulfate were nondetectable in/on almond kernels
harvested 39 or 58 days following the last of multiple applications
of a representative WP formulation at exaggerated (2.4x) seasonal
rate ; the reported limits of detection were 0.2 and 0. 1 ppm
respectively. A preharvest interval for almonds has presently not
been established. [Almond, nutmeat]
Following applications of a representative WP formulation
reflecting the maximum registered use pattern, the combined
endosulfan residues in/on almond hulls ranged from 0. 12 to 0.77
ppm. [Almond, hulls]
Data reflecting the maximum registered use pattern are
unavailable. However, data reflecting applications at exaggerated
(2x) seasonal rate indicate that the combined endosulfan residues
in/on apples ranged from 0.46 to >0.47 ppm using the EC
formulation, and from 0.69 to 0.84 ppm using the WP formulation.
The reassessed tolerance is in harmony with the proposed Codex
MRL (Step 5/8) of 1.0 ppm for pome fruits. [Apple]
The available data for peaches may be translated to apricots.
[Apricot]
No longer a registered use.
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on barley grain
ranged from <0. 15 to <0.30 ppm..
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on barley straw
ranged from <0. 15 to 0.35 ppm.
Following applications of a representative WP or EC formulation
reflecting the maximum registered use pattern, the combined
endosulfan residues were below 2.0 ppm in/on lima beans, snap
beans, red kidney beans, string beans, and sutler red beans . The
reassessed tolerance only applies to bans, dry since the succulent
bean use is being deleted. [Bean, succulent seed]
No longer a registered use. [Beet, sugar, root]
40
-------
Commodity
Established
Tolerance
(ppm)
Reassessed
Tolerance
(ppm)
Comments
[Correct Commodity Definition]
Blueberry
0.1 (N)
0.3
Following applications of a representative EC formulation
reflecting exaggerated use pattern, no detectable residues (<0.1
ppm) of endosulfan or endosulfan sulfate were detected in/on
blueberries . [Blueberry]
Broccoli
2.0
3.0
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on broccoli ranged
from 0.16 to 2.41 ppm using the EC formulation, and from 0.26 to
1.92 ppm using the WP formulation. The registrants may elect to
retain the current tolerance level by amending the registered
broccoli use pattern and by submitting additional residue data in
support of any label amendments.
Brussels sprouts
2.0
2.0
Data reflecting the maximum registered use pattern are
unavailable. However, data reflecting applications of a
representative EC formulation at exaggerated (3.5x) seasonal rate
indicate that the combined residues of endosulfan in/on Brussels
sprouts were below 2.0 ppm .
Cabbage
2.0
4.0
Following applications of a representative EC formulation
reflecting the maximum registered use pattern, the combined
endosulfan residues were 3.1 ppm in/on cabbage with wrapper
leaves and nondetectable (O.02 ppm) in/on cabbage without
wrapper leaves . The reassessed tolerance is based on data from
cabbage with wrapper leaves.
Carrots
0.2
0.2
Following applications of a representative EC formulation
reflecting the maximum registered use pattern, the combined
endosulfan residues in/on carrots were generally below 0.2 ppm .
[Carrot]
Cattle, fat
0.2
13
The highest residues obtained in milk and tissue samples collected
from the highest feeding level of the combined residues of
endosulfan (a and p isomers) and endosulfan sulfate in animal
commodities are as follows :
Fat of cattle, goats, hogs, horses, and sheep 13.0 ppm
Meat byproducts (except liver) of cattle, goats, hogs, and hdrifeppm
Liver of cattle, goats, hogs, and horses 5.0 ppm
Meat of cattle, goats, hogs, and horses 2.0 ppm
Milk, fat 2.0 ppm
Cattle, meat
by products
0.2
Cattle, mbyp
= 1.0
Cattle, liver =
5.0
[Cattle, meat byproducts (except liver)}
[Cattle, liver}
Cattle, meat
0.2
2.0
Cauliflower
2.0
2.0
Following applications of a representative EC formulation
reflecting the maximum registered as well as exaggerated use
patterns, the combined endosulfan residues in/on cauliflower were
below 0.78 ppm. Due to the limited number of data points
reflecting treatments at Ix, the cauliflower tolerance is reassessed
at 2.0 ppm.
41
-------
Commodity
Established
Tolerance
(ppm)
Reassessed
Tolerance
(ppm)
Comments
[Correct Commodity Definition]
Celery
2.0
These new residue data reflect application(s) of representative
emulsifiable concentrate (EC) and wettable powder (WP)
formulations at the respective maximum registered seasonal rates
for celery.
The combined residues in/on treated untrimmed celery samples
ranged from 0.99 to 4.50 ppm following application of the EC
formulation, and from 1.18 to 7.0 ppm following application of the
WP formulation.
Cherry
2.0
Cherry, sweet
= 2.0
Cherry, sour
= 2.0
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on sweet cherries
ranged from <0.17 to 1.46 ppm using the EC formulation, and from
<0.15 to 0.33 ppm using the WP formulation. The combined
endosulfan residues in/on sour cherries ranged from <0.15 to 1.35
ppm using the EC formulation, and from <0.15 to 0.19 ppm using
the WP formulation.
[Cherry, sweet] and [Cherry, sour]
Collards
2.0
2.0
The available data reflecting the maximum registered use pattern
for collards are very limited. Following application of a
representative EC formulation at 0.75x the maximum registered
seasonal rates, the combined endosulfan residues in/on collards
harvested 20 days posttreatment were 1.591-1.782 ppm . The data
submitted for spinach, sugar beet tops, kale, or mustard greens may
additionally be used to estimate endosulfan residues in/on collards.
Corn, sweet
(K+CWHR)
0.2
0.20
The reassessed tolerance is contingent upon the requested label
revisions specifying the parameters of use patterns for which
adequate data are available.
Cottonseed
1.0
1.0
Following applications of a representative EC formulation
reflecting the maximum registered use pattern, the combined
endosulfan residues in/on cottonseed were below 1.0 ppm .
[Cotton, undelinted seed]
Cotton gin byproducts
30
The combined residues of endosulfan (a and P isomers) and
endosulfan sulfate ranged from 8.27 to 27.5 ppm in/on cotton gin
byproducts harvested 13-14 days following a treatment schedule
(after bolls open) similar to the one described above for
cottonseed. No cotton gin byproducts data reflecting treatments
made to cotton plants until bolls open have been submitted;
however, because residues are expected to be lower from this use
pattern, the Agency will not require additional cotton gin
byproducts data for reregistration.
Cucumber
2.0
Reassign
Tolerance should be revoked with the concomitant establishment
of a tolerance for Cucurbit Vegetables (Crop Group 9). Following
applications reflecting the maximum registered use pattern, the
combined endosulfan residues in/on cucumbers ranged from 0.26
to 0.66 ppm using the EC formulation, and from <0.16 to 0.40 ppm
using the WP formulation. Adequate data are now available for
cucumber, melon, and squash which are the representative
commodities of Cucurbit Vegetables Group (Crop Group 9).
[Cucumber]
Eggplant
2.0
1.0
The available data for tomato may be translated to eggplant.
42
-------
Commodity
Filbert
Goat, fat
Goat, meat byproduct
Goat, meat
Grape
Hog, fat
Hog, meat byproduct
Hog, meat
Horse, fat
Horse meat byproduct
Horse, meat
Kale
Lettuce
Established
Tolerance
(ppm)
0.2 (N)
0.2
0.2
0.2
2.0
0.2
0.2
0.2
0.2
0.2
0.2
2.0
2.0
Reassessed
Tolerance
(ppm)
0.20
13
Goats, mbyp
= 1.0
Goats, liver =
5.0
2.0
Revoke
13
Hog, mbyp =
1.0
Hog, liver =
5.0
2.0
13
Horses, mbyp
= 1.0
Horses, liver
= 5.0
2.0
2.0
Lettuce, head
= 11
Lettuce, leaf
= 6.0
Comments
[Correct Commodity Definition]
The available data indicate that residues of endosulfan or
endosulfan sulfate were nondetectable in/on filbert nuts harvested
76-88 days following the last of multiple applications of
representative WP formulations at 1.3-1.6x the maximum
registered seasonal rate. The method's limit of detection was not
specified. [Filbert]
The highest residues obtained in milk and tissue samples collected
from the highest feeding level of the combined residues of
endosulfan (a and p isomers) and endosulfan sulfate in animal
commodities are as follows :
Fat of cattle, goats, hogs, horses, and sheep 13.0 ppm
Meat byproducts (except liver) of cattle, goats, hogs, and hdrifeppm
Liver of cattle, goats, hogs, and horses 5.0 ppm
Meat of cattle, goats, hogs, and horses 2.0 ppm
Milk, fat 2.0 ppm
[Goat, meat byproducts (except liver)]
[Goat, liver]
Use being deleted as part of dietary risk mitigation.
[Hog, meat byproducts (except liver)]
[Hog, liver]
[Horse, meat byproducts (except liver)]
[Horse, liver]
Following applications of a representative EC formulation
reflecting the maximum registered use pattern, the combined
endosulfan residues in/on kale were 1.214-1.295 ppm .
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on head lettuce (with
wrapper leaves) ranged from <0. 1 8 to 4.28 ppm using the EC
formulation, and from 0.21 to 10. 11 ppm using the WP
formulation. The combined endosulfan residues in/on leaf lettuce
ranged from <0. 1 5 to 4.49 ppm using the EC formulation, and from
0. 17 to 5.72 ppm using the WP formulation. In lieu of proposing
higher tolerances, the registrants may elect to retain the current
tolerance level by amending the registered lettuce use pattern and
by submitting additional residue data in support of any label
amendments. [Lettuce, head] and [Lettuce, leaf]
43
-------
Commodity
Nut, Macadamia
Melon
Milk, fat (=N in whole
milk)
Mustard greens
Mustard seed
Nectarine
Oat, grain
Oat, straw
Peach
Pear
Pea, succulent
Pecans
Pepper
Pineapple
Established
Tolerance
(ppm)
0.2 (N)
2.0
0.5
2.0
0.2 (N)
2.0
0.1 (N)
0.2 (N)
2.0
2.0
2.0
0.2 (N)
2.0
2.0
Reassessed
Tolerance
(ppm)
0.20
Revoke
2.0
2.0
Revoke
2.0
0.3
0.4
2.0
2.0
Revoke
Revoke
2.0
1.0
Comments
[Correct Commodity Definition]
Following applications of a representative WP or EC formulation
reflecting exaggerated use pattern, no detectable residues of
endosulfan or endosulfan sulfate were detected in/on macadamia
nuts. The analytical method's limit of detection was not specified.
[Macadamia nut]
Tolerance should be revoked with the concomitant establishment
of a tolerance for Cucurbit Vegetables (Crop Group 9). Following
applications reflecting the maximum registered use pattern, the
combined endosulfan residues in/on cantaloupes ranged from
<0 . 1 5 to 0 . 50 ppm using the EC formulation, and from 0 . 22 to 0 . 76
ppm using the WP formulation. [Melon subgroup (crop subgroup
9A]
[Milk]
The available data reflecting the established 21 -day PHI for
mustard greens are very limited . The data submitted for spinach,
collards, kale, or turnip greens may be used to estimate endosulfan
residues in/on mustard greens.
No longer a registered use.
The available data for peaches may be translated to nectarines.
[Nectarine]
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on oat grain ranged
from <0. 15 to O.30 ppm..
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on oat straw ranged
from <0. 15 to O.32 ppm..
Following applications of a representative WP formulation
approximating the maximum registered use pattern, the combined
endosulfan residues in/on peaches were below 2.0 ppm .
Following applications of a representative WP formulation
approximating the maximum registered use pattern, the combined
endosulfan residues in/on pears were 0.95-1 .00 ppm. EHie to the
limited number of data points reflecting treatments at Ix, the pear
tolerance is reassessed at 2.0 ppm .
Use being deleted as part of dietary risk mitigation.
Use is being deleted.
Following applications of a representative WP or EC formulations
approximating the maximum registered use pattern, the combined
endosulfan residues in/on bell and sweet peppers are not expected
to exceed 2.0 ppm .
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on pineapples ranged
from >0.08 to 0.50 ppm. [Pineapple]
44
-------
Commodity
Plum, Prune
Potato
Prunes
Pumpkin
Rape seed
Raspberry
Rye, grain
Rye, straw
Safflower, seed
Sheep, fat
Sheep, meat byproduct
Sheep, meat
Spinach
Squash, summer
Squash, winter
Established
Tolerance
(ppm)
2.0
0.2 (N)
2.0
2.0
0.2
0.1
0.1 (N)
0.2 (N)
0.2 (N)
0.2
0.2
0.2
2.0
2.0
2.0
Reassessed
Tolerance
(ppm)
2.0
0.2
2.0
Reassign
Revoke
Revoke
0.3
0.3
Revoke
13
Sheep, mbyp
= 1.0
Sheep, liver =
5.0
2.0
Revoke
Reassign
Reassign
Comments
[Correct Commodity Definition]
Data reflecting the maximum registered use pattern are
unavailable. However, data reflecting applications of a
representative WP or EC formulation at an exaggerated seasonal
rate indicate that the combined endosulfan residues in/on French
prunes were below 2.0 ppm. [Plum]
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on potatoes were
mostly nondetectable . The analytical method's limit of detection
was not specified. [Potato]
Data reflecting the maximum registered use pattern are
unavailable. However, data reflecting applications of a
representative WP or EC formulation at an exaggerated seasonal
rate indicate that the combined endosulfan residues in/on French
prunes were below 2.0 ppm. [Prune]
Tolerance should be revoked with the concomitant establishment
of a tolerance for Cucurbit Vegetables (Crop Group 9). The
available data for cucumber, melon, and summer squash may be
translated to pumpkin and winter squash. [Pumpkin]
No longer a registered use.
No longer a registered use.
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on rye grain ranged
from <0. 15 to O.30 ppm.
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on rye straw ranged
from <0. 15 to O.30 ppm..
No longer a registered use.
[Sheep, meat byproducts (except liver)]
[Sheep, liver]
Use being deleted as part of dietary risk mitigation.
Tolerance should be revoked with the concomitant establishment
of a tolerance for Cucurbit Vegetables (Crop Group 9). Following
applications reflecting the maximum registered use pattern, the
combined endosulfan residues in/on summer squash ranged from
<0. 1 5 to 0.23 ppm using the EC formulation, and from <0. 1 5 to
0.25 ppm using the WP formulation.
Tolerance should be revoked with the concomitant establishment
of a tolerance for Cucurbit Vegetables (Crop Group 9). The
available data for cucumber, melon, and summer squash may be
translated to pumpkin and winter squash.
45
-------
Commodity
Strawberry
Sugarcane
Sunflower, seed
Sweet potato
Tomato
Turnip, greens
Walnut
Watercress
Wheat, grain
Wheat, straw
Established
Tolerance
(ppm)
2.0
0.5
2.0
0.2
2.0
2.0
0.2 (N)
2.0
0.1 (N)
0.2 (N)
Reassessed
Tolerance
(ppm)
2.0
Revoke
Revoke
0.15
1.0
2.0
0.2
Revoke
0.30
0.40
Comments
[Correct Commodity Definition]
Data reflecting the maximum registered use pattern are
unavailable. Data reflecting applications of a representative EC
formulation at 0.33-0.67x the maximum seasonal rate indicate that
the combined residues of endosulfan in/on strawberries without
caps were below 0.60 ppm . By extrapolation to the maximum use
rate, the Science Chapter to the Endosulfan Reregistration Standard
concluded that residues are not likely to exceed the established
tolerance. [Strawberry]
No longer a registered use.
No longer a registered use.
The available data indicate that endosulfan residues of concern
were each O.05 ppm (nondetectable) in/on sweet potatoes
following treatments at the maximum registered use pattern.
[Sweet potato]
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on tomatoes ranged
from <0. 15 to 0.91 ppm using the EC formulation, and from <0. 15
to 0.97 ppm using the WP formulation. [Tomato]
Data reflecting the maximum registered use pattern are
unavailable. The data submitted for spinach, collards, kale, or
mustard greens may be used to estimate residues in/on turnip
greens. [Turnip, tops]
The available data indicate that residues of endosulfan or
endosulfan sulfate were nondetectable in/on walnuts harvested 36-
39 days following the last of multiple applications of a
representative WP and EC formulations at exaggerated (2.7-3. 3x)
seasonal rate; the limits of detection were not reported. [Walnut]
No longer a registered use.
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on wheat grain
ranged from <0.15 to O.30 ppm.
Following applications reflecting the maximum registered use
pattern, the combined endosulfan residues in/on wheat straw
ranged from <0.15 to O.38 ppm.
Tolerance To Be Proposed Under 40 CFR §180.182
Apple, pomace, wet
Corn, sweet, forage
Corn, sweet, stover
None
None
None
5.0
12
14
The recommended tolerance is based on a F1AFT combined
endosulfan residue of 0.77 ppm and a concentration factor of 6x.
The submitted data for sweet corn forage and stover indicate that
the combined residues of endosulfan (a and P isomers) and
endosulfan sulfate were 4.2-12.0 ppm in/on sweet corn forage (n=6
samples) harvested 7 days and 0.76-13.92 ppm in/on sweet corn
stover (n=6 samples) harvested 1 1-45 days following the last of
two foliar applications, with a 6- to 7-day retreatment interval of a
representative 3 Ib/gal EC formulation at 1.0 Ib ai/A/application
(Ix the proposed maximum single and seasonal application rates)
using ground equipment.
46
-------
Commodity
Cotton, gin byproducts
Cucurbit Vegetables
(Crop Group 9)
Pineapple, process
residue
Turnip, root
Vegetables Cucurbit,
Group
Established
Tolerance
(ppm)
None
None
None
None
None
Reassessed
Tolerance
(ppm)
30
1.0
18
0.2
1.0
Comments
[Correct Commodity Definition]
Adequate data are available for representative commodities.
The recommended tolerance is based on a HAFT combined
endosulfan residue of 0.44 ppm and a concentration factor of 41x.
The recommended tolerance is based on translation of data from
carrot and potato.
Adequate data are available for representative commodities.
Tolerance Listed Under 40 CFR §180.182 (a) (2)
Dried tea
24
(reflecting <
0.1 ppm
residues in
beverage
tea)
24
(reflecting <
0.1 ppm
residues in
beverage tea)
This tolerance has been moved from 40 CFR §185.2600.
Codex Harmonization
The Codex Alimentarius Commission has established several maximum residue limits
(MRLs) for residues of endosulfan in/on various plant and animal commodities. The Codex
MRLs are expressed in terms of the sum of a- and p-endosulfan and endosulfan sulfate (fat
soluble). When the U.S. tolerance expression is revised to specify the a and |3 isomers of the
parent, Codex MRLs and U.S. tolerances will be harmonized. A numerical comparison of the
Codex MRLs and the corresponding reassessed U.S. tolerances is presented in Table 19.
Table 19 indicates that U.S. tolerances and the Codex MRLs for endosulfan are compatible for
carrot, cottonseed, fruits, meat, pome fruits (apples), potato, spinach, and sweet potato. For the
remainder of commodities listed in Table 19, the U.S. tolerances and the Codex MRLs are
incompatible because of differences in registrations or good agricultural practices.
Table 19. Codex MRLs and Applicable U.S. Tolerances for Endosulfan
Codex
Commodity, As Defined
Alfalfa forage (green)
Broccoli
Cabbages, Head
Cabbages, Savoy
Carrot
Cauliflower
Celery
MRL
(mg/kg)
1
0.5
1
2
0.2
0.5
2
Step
5/8
5
5
5
CXL
5
5/8
Reassessed U.S.
Tolerance
(ppm)
Revoke
3.0
4.0
4.0
0.20
2.0
8.0
Comments
No longer a registered use.
Compatibity exists.
47
(continued; footnotes follow)
-------
Codex
Commodity, As Defined
Chard
Cherries
Chicory leaves
Clover
Common bean (pods
and/or immature seeds)
Cotton seed
Cotton seed oil, crude
Endive
Fruits
Garden peas (young
pods)
Kale
Lettuce, Head
Lettuce, Leaf
Meat
Milks
Onion, Bulb
Plums (including Prunes)
Pome fruits
Potato
Rice
Spinach
Sugar beet
Sugar beet leaves or tops
Sweet potato
Tea, Green, Black
Trefoil
MRL
(mg/kg)
2
1
1
1
0.5
1
0.5
1
2
0.5
1
1
1
0.2 (carcass
fat)
0.02 '
0.2
1
1
0.2
0.1
2
0.1
1
0.2
30
1
Step
5
5/8
5
5/8
5
CXL
CXL
5
CXL
5/8
5/8
5/8
5/8
CXL
CXL
CXL
5/8
5/8
CXL
CXL
5/8
5/8
5/8
CXL
CXL
5/8
Reassessed U.S.
Tolerance
(ppm)
--
2.0
--
--
2.0
1.0
-
--
2.0 each for apricots,
grapes, nectarines,
peaches, pears, plums,
prunes, and strawberries
--
2.0
11.0
6.0
0.20
0.50
-
2.0
1.0
0.20
-
2.0
Revoke
--
0.15
24 (reflecting <0. 10
ppm residues in
beverage tea)
--
Comments
No U.S. registrations.
No U.S. registrations.
No U.S. registrations.
Compatibility exists.
No U.S. registrations.
Compatibility exists for some fruit
crops.
No U.S. registrations.
Compatibility exists.
No U.S. registrations.
Compatibility exists.
Compatibility exists.
No U.S. registrations.
Compatibity exists.
No longer a registered use.
Compatibility exists.
No U.S. registrations.
The residue is fat-soluble and MRLs for milk and milk products are derived as explained in the introductions to
Volume XIII of Codex Alimentarius.
2. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
48
-------
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other such endocrine effects as the Administrator may designate."
Following the recommendations of its Endocrine Disrupter Screening and Testing Advisory
Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of
the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that
effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops and resources
allow, screening of additional hormone systems may be added to the Endocrine Disrupter
Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
Agency's EDSP have been developed, endosulfan may be subjected to additional screening
and/or testing to better characterize effects related to endocrine disruption.
3. Labels
The following risk mitigation measures are necessary to mitigate the risks identified in
the endosulfan risk assessment as a result of dietary exposure from food, to workers who handle
endosulfan and workers re-entering fields treated with endosulfan, and for ecological risks to
non-target organisms. A number of label amendments, in addition to the existing label
requirements, are necessary in order to reflect this mitigation
a. Agricultural Use Exposure Reduction Measures
For agricultural use, the following measures are required, in addition to the existing
labeling requirements to address dietary (food), drinking water, occupational handler and
ecological risks of concern. See Table 20 for additional information by crop.
Dietary (food)
• Delete use on succulent beans, succulent peas, spinach, and grapes.
Dietary (drinking water) and Ecological
Delete use on pecans
• Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2.5 Ibs./ai/A for pome
fruit, stone fruit and citrus.
• Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2 Ibs./ai/A for melons,
cucurbits, lettuce, tomatoes, sweet potatoes, cotton (ground), broccoli, cauliflower,
cabbage, kohlrabi, brussels sprouts, strawberries, filberts, walnuts, almonds, macadamia
nuts, peppers, eggplant, potatoes, carrots, dry beans, dry peas, and tobacco.
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 1.5 Ibs./ai/A for sweet
corn, cotton (aerial) and blueberries.
49
-------
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 1 Ib./ai/A for celery.
Require 100 ft. spray buffer for ground applications between a treated area and water
bodies.
Require 30 ft. maintained vegetative buffer strip between a treated area and water bodies.
Require all products to be Restricted Use
Restrict use on cotton to AZ, CA, NM, OK and TX only.
Restrict use on tobacco to IN, KY, OH, PA, TN and WV only.
Occupational
Require all wettable powers to be packaged in water soluble bags.
Cancel use of wettable powders on tomatoes, sweet corn, sweet potatoes, cotton, small
grains, alfalfa (seed), carrots, dry beans, dry peas, pineapples, and tobacco.
Cancel aerial application using the wettable powder formulation on pome fruits, stone
fruits, citrus, blueberries, strawberries, collard greens (seed), kale (seed), mustard greens
(seed), radish (seed), turnip (seed), rutabaga (seed), broccoli, (seed), cauliflower (seed),
kohlrabi (seed), cabbage (seed), filberts, walnuts, almonds, and macadamia nuts.
Require closed mixing/loading systems for aerial application using the EC formulation on
pome fruits, stone fruits, citrus, sweet corn, sweet potatoes, cotton, collard greens (seed),
kale (seed), mustard greens (seed), radish (seed), turnip (seed), rutabaga (seed), broccoli,
(seed), cauliflower (seed), kohlrabi (seed), cabbage (seed), blueberries, small grains,
alfalfa (seed), filberts, walnuts, almonds and macadamia nuts.
Require closed cabs for airblast applications on pome fruits, stone fruits, citrus, filberts,
walnuts, almonds and macadamia nuts.
Prohibit use of high pressure handwands with rates greater than 0.005 Ibs/ai/gal.
Increase REI to 48 hours for all crops except as noted in the following bullets/
Increase REI for WP products to 3 days for melons and cucurbits.
Increase REI for WP products to 4 days for lettuce, celery, pome fruit, stone fruit, citrus,
collard greens, kale, mustard greens, radish, turnip, rutabaga, ornamental trees and
shrubs.
Increase REI for WP products to 5 days for collard greens (seed), kale (seed), mustard
greens (seed), radish (seed), turnip (seed) and rutabaga (seed).
Increase REI for WP products to 9 days for blueberries, broccoli, cauliflower, kohlrabi,
cabbage, and brussels sprouts.
Increase REI for WP products to 12 days for broccoli (seed), cauliflower (seed), kohlrabi
(seed), and cabbage (seed).
Increase REI for EC products to 3 days for sweet potatoes
Increase REI for EC products to 4 days for broccoli, cauliflower, kohlrabi, cabbage, and
brussels sprouts.
Increase REI for EC products to 6 days for blueberries.
Increase REI for EC products to 7 days for broccoli (seed), kohlrabi (seed), and cabbage
(seed).
Increase REI for EC products to 17 days for sweet corn.
50
-------
Occupational and Ecological
• Reduce maximum application rate to 2.5 Ibs./ai/A for pome fruit, stone fruit, citrus,
ornamental trees and shrubs.
Reduce maximum application rate to 1.5 Ibs/a/A for blueberries and cotton (ground).
Reduce maximum application rate to 1.0 Ib/ai/A for broccoli (not for seed), kohlrabi (not
for seed), cabbage (not for seed), cauliflower (not for seed) and strawberries.
• Reduce maximum application rate to 0.75 Ibs/ai/A for cotton (aerial) and kale.
• Reduce maximum application rate to 0.005 Ibs./ai/gal for all tree bark treatments.
D. Regulatory Rationale
The following is a summary of the rationale and mitigation measures for managing risks
associated with the current use of endosulfan. Specific label language is set forth in the
summary table in Section V.
1. Human Health Risk Mitigation
a. Dietary (food)
The following discussion addresses risk mitigation measures pertaining to dietary
exposure to residues of endosulfan in food.
Acute (Food)
Acute dietary risk from food exceeded the Agency's level of concern for the most highly
exposed population subgroup, children 1-6 years old. The risk assessment yielded a percent
acute PAD value of 150% for children 1-6 years old. To mitigate the acute dietary risk (food),
the registrants have agreed to delete the following uses: succulent beans, succulent peas, spinach
and grapes. Based on this mitigation, the acute risk from food exposure falls below the
Agency's level of concern with the % aPAD occupied for children 1-6 years old being 80%.
Therefore, removal of these uses will fully address acute dietary risk from food.
Chronic (Food)
The chronic dietary risk for endosulfan does not exceed the Agency's level of concern
(i.e., is less than 100% of the cPAD) for all sub-populations, including the most highly exposed
subgroup, children (1-6 years), whose dietary exposure occupies 17% of the cPAD. No
mitigation measures are necessary at this time to address chronic dietary risk from food.
b. Drinking Water
Surface water drinking water estimated concentrations were derived from the PRZM-
EXAMS model with the Standard Index Reservoir and percent crop area (PCA). Ground water
51
-------
estimated concentrations were derived from the SCI-GROW Model. These are screening level
models designed to provide high-end estimates of potential pesticide exposure. Such
predictions provide a screen to eliminate those chemicals that are not likely to cause concerns in
drinking water. Estimated concentrations exceeding the drinking water level of concern
(DWLOC) in drinking water risk assessments using the screening model estimates do not
necessarily mean a risk of concern actually exists, but may indicate the need for better data (e.g.,
monitoring studies specific to use patterns and drinking water sources) on which to confirm
decisions.
Based on model predictions using currently registered uses, the drinking water EECs for
endosulfan and its degradate, endosulfan sulfate, in surface water range from 4.49 ppb (cotton
scenario) to 23.86 ppb (apple scenario) for acute exposure, and from 0.53 ppb (cotton scenario)
to 1.5 ppb (apple scenario) for chronic exposure. The acute and chronic EEC for endosulfan in
groundwater i s 0.012 ppb.
The chronic dietary risks from drinking water exposure from ground water and surface
water sources do not exceed the Agency's level of concern. The acute dietary risks from
drinking water exposure from surface water and ground water sources are above the Agency's
level of concern for most subpopulations. The mitigation measures taken to address food risks
result in higher DWLOCs and, therefore, more room in the risk cup for water exposures. For the
most highly exposed subpopulations the acute DWLOCs following mitigation are 3 ppb for
children 1-6 and 2.3 ppb for all infants. When these mitigation measures to reduce the dietary
risks from food are considered, the acute dietary risks from drinking water exposure from ground
water sources do not exceed the Agency's level of concern. This leaves only acute risks from
surface water sources remaining above the Agency's level of concern. The Agency expects that
actual exposure from drinking water is unlikely to be as high as the levels used in the
development of the surface water estimates based on the rationale discussed below. Therefore,
given the anticipated impacts on water resources from implementing the risk reduction measures
contained in this document and the characterization of the Agency's water modeling presented
below, the Agency believes that the risks from drinking water are not of concern.
The drinking water risk assessments are based on screening level models that are
conservative in their estimates of drinking water exposure. Actual exposure is expected to be
lower than the EEC's reported in the RED. One reason for this is that the percent cropped area
(PCA) assumption for apples used in the model is 0.87, the default assumption. This means the
model assumes that 87% of a watershed is planted with apples and that 100% of this crop is
treated with endosulfan, which may be unlikely to occur especially considering that the PCA
calculated for major crops like corn and cotton using data submitted to the Agency are 0.46 and
0.20 respectively. To add further perspective, the EEC derived from this screening-level model
for cotton where a crop-specific PCA has been developed is 4.49 ppb. This is significantly lower
than the apple scenario where the default PCA was used and results in risk estimates being below
the Agency's level of concern for most subpopulations and nearly so for the most highly exposed
subpopulations once food mitigation is considered. Cotton is also the crop where the most
endosulfan is used.
52
-------
The risk reduction measures contained in this RED, including the deletion of the
succulent bean, succulent pea, grape, pecan and spinach uses, reductions in maximum
application rates, reductions in maximum seasonal application rates , reductions in the maximum
number of applications allowed per season, implementation of the 100 ft. setback for ground
applications and the implementation of a 30 foot vegetative buffer strip are expected to reduce
the amount of endosulfan available to reach surface waters. Buffer strips are expected to be
more effective in mitigating acute risk scenarios in the case of endosulfan. This supports the
Agency's belief that drinking water risks will be reduced to a level at which the risk cup is not
exceeded.
For endosulfan, the Agency is also requiring confirmatory surface water monitoring data
to evaluate actual acute concentrations of endosulfan in surface water sources of drinking water.
This monitoring data is to be generated from a multi-year sampling program involving
community water systems from surface water sources in multiple locations in different regions of
the country to represent different use sites, crops, soil types, and rainfall regimes. Water samples
are to be analyzed to determine the concentrations of parent endosulfan and each of the
environmental degradates of toxicological concern. Also, prior to initiating this sampling
program, the registrant is required to submit a study protocol to the Agency to ensure that the
sampling locations and procedures are adequate to confirm the drinking water risk management
conclusions.
c. Aggregate Risk Mitigation
The Agency's aggregate risk assessment for endosulfan is based on exposure estimates
for food and uses a screening-level assessment of modeled estimates for drinking water
exposure. Dietary (food) risk estimates are based on a refined assessment that incorporates
percent crop treated data, monitoring data, and processing data.
Acute Exposure
The acute aggregate risk assessment for endosulfan combines exposure from food and
drinking water sources only. Acute dietary (food) risk estimates are below 100% of the aPAD
for the US population and all population subgroups when the use deletions mentioned earlier that
are needed to mitigate dietary risks are considered. When this mitigation is considered, all
infants are the most highly exposed population subgroup and have an acute drinking water level
of comparison (DWLOC) of 2.3 ppb. Based on screening-level model predictions of the
remaining supported uses, the acute (peak) drinking water estimated concentration in surface
water is 23.9 ppb which is of risk concern to the Agency. The screening-level model predictions
of acute concentrations in ground water is 0.0012 ppb, which is less than the DWLOC and not of
risk concern to the Agency.
However, given the anticipated impacts on water resources from implementing the risk
reduction measures contained in this document and the characterization of the Agency's water
modeling presented above, the Agency believes that actual acute concentrations of endosulfan in
53
-------
surface water are less than the DWLOC and are not of concern. To confirm this, surface water
monitoring data is required.
Chronic Exposure
The chronic aggregate risk assessment for endosulfan combines exposure from food and
drinking water sources only. Chronic dietary (food) risk estimates are well below 100% of the
cPAD for the US population and all population subgroups. Children 1-6 years old are the most
highly exposed population subgroup and have in a chronic DWLOC of 5 ppb. Based on
screening-level model predictions of the current uses of endosulfan the average (chronic)
estimated concentration in surface water is 1.5 ppb, which is not of risk concern to the Agency.
d. Occupational Risk Mitigation
(1) Agricultural Handler Risk Mitigation
It is the Agency's policy to mitigate occupational risks to the greatest extent necessary
and feasible with personal protective equipment and engineering controls. In managing these
risks, EPA must take into account the economic, social, and environmental costs and benefits of
the pesticide's use. A wide range of factors are considered in making risk management decisions
for worker risks. These factors include, in addition to the calculated MOEs, incident data, the
nature and severity of adverse effects, uncertainties in the risk assessment, the cost, availability
and relative risk of alternatives, importance of the chemical in integrated pest management
(IPM) programs, and other similar factors.
Handlers
As summarized in Table 8, occupational risks are of concern (i.e., MOEs < 100) for many
scenarios, even when maximum PPE (i.e, double layer clothing, gloves, and a respirator) are
utilized. Handler risks are also of concern for some scenarios with engineering controls (closed
mixing/loading, enclosed cabs). Engineering controls are considered to be the maximum
feasible mitigation.
EPA has determined that handler risks from exposure to endosulfan in the scenarios
listed below would be adequately mitigated, when other mitigation such as rate reductions are
considered, through use of the following PPE: long-sleeved shirt and long pants, shoes, socks,
chemical-resistant gloves and an organic vapor respirator.
• Mixing/loading liquids for chemigation.
• Mixing/loading liquids for groundboom application.
• Mixing/loading liquids for airblast applications.
• Mixing/loading liquids for rights-of-way sprayers.
• Mixing/loading liquids for plant and root dips.
Applying sprays with groundboom equipment.
54
-------
Mixing/loading/applying with a low pressure handwand.
Mixing/loading/applying with a backpack sprayer.
EPA has determined that worker risks from exposure to endosulfan in the scenarios listed
below would be adequately mitigated, when other mitigation such as rate reductions are
considered, through use of the following PPE: coveralls worn over long-sleeved shirt and long
pants, chemical-resistent footwear, chemical-resistant gloves, chemical-resistent apron (for
mixing and loading) and a organic vapor respirator.
• Mixing/loading/applying with a high pressure handwand.
• Flagging aerial spray applications.
Mixing/loading liquid for aerial application for crops with maximum application rates of
less than 1.5 Ibs/ai/A except for cotton, alfalfa (seed) and small grains.
The mitigation measures needed to address handler risks which are of concern at or
above the maximum PPE scenario are outlined, by crop, in Table 20 below. These steps include
placing all wettable powder products in water soluble bags, the deletion of some uses from WP
products, deletion of aerial application of WP products for crops with maximum application rates
greater than or equal to 1.5 Ibs/ai/A and for cotton, alfalfa (seed) and small grains, requiring
closed mixing/loading systems for aerial applications of the EC formulation for some uses,
requiring closed cabs for all airblast applications except for ornamental trees/shrubs, requiring
enclosed cockpits for all aerial applications and rate reductions. Scenarios w/ engineering
controls for mixing/loading liquids and applying with airblast equipment include the need for
baseline clothing plus chemical resistant gloves and a chemical-resistent apron (when mixing
and loading). Since all wettable powder products will be packaged in water soluble bags,
mixing/loading scenarios for this formulation will also include baseline clothing, chemical
resistant gloves and a chemical-resistent apron.
As mentioned earlier there were three scenarios that were not evaluated due to a lack of
data available to conduct an assessment. For the mixing/loading/applying wettable powders with
backpack sprayer and mixing/loading/applying wettable powders with a high pressure hand
wand scenarios, the mitigation to place all wettable powders in water soluble bags will
effectively preclude the use of WPs for these equipment types. Therefore, no additional
information is required for these scenarios.
Post-Application
EPA completes exposure assessments on postapplication workers for various crops and
activities at intervals following the application until risk falls below a target level. For
endosulfan, the target level for risk concerns is an MOE of 100.
In order to determine the REI for a crop, EPA calculates the number of days that must
elapse after pesticide application until residues dissipate and risk to a worker falls below the
target MOE (100 for endosulfan). Occupational risks are regulated under the FIFRA section
55
-------
3(c)(5) standard of no unreasonable adverse effects which means that both risks and benefits
must be considered in making a risk management decision. This standard may be met at a level
below the target MOE when there are benefits associated with a specific activity. As the worker
exposure database has improved, risk assessments are now conducted for a variety of post
application activities based on the level of exposure for each worker activity. For a specific
crop/pesticide combination, the duration required to achieve the target MOE can vary depending
on the activity assessed.
In general, EPA prefers to set a single REI for all activities related to a crop or crop
group without additional activity-based labeling. This approach is favored because handlers and
workers are more likely to understand and comply with simpler labels. Also, permitting entry
for some activities during the REI could cause confusion and compromise the effectiveness of
the Worker Protection Standard (WPS). However, when the consideration of risks and benefits
indicate that a single REI is unworkable, EPA may consider either setting an REI with early
entry exceptions for one or more critical tasks or establishing an entry prohibition for a specific
task after the REI has expired. For endosulfan, no critical activities have been identified to
warrant the use of an activity-based exception or prohibition. However, during the 60-day
comment period for this RED, EPA will accept further comments from growers regarding needs
for additional REI exceptions for specific activities, and will consider such exceptions where
needed if there are adequate MOEs and/or benefits associated with such activities.
In weighing worker risks and benefits, the Agency considered the timing of field
activities that are critical to crop production. For many of the endosulfan uses discussed below,
scouting and irrigation are critical activities in crop production, and these activities routinely
need to be performed soon after application. In evaluating the restricted entry intervals, the
Agency considered the exceptions to the WPS that could inform the decision. EPA's proposed
REIs take into account the flexibility already provided by these exceptions. Scouting is a
handler activity under the WPS, so anyone performing this activity may legally enter the treated
field during the REI provided they use the personal protective equipment (PPE) specified on the
label. In addition, if the scout is a certified crop advisor as defined in the WPS (40 CFR
170.204(b)), the individual can determine the appropriate PPE to be used. For many of these
crops, irrigation equipment is not routinely moved by hand, instead, the primary activity involves
entering the field to turn the watering equipment on and off. This activity is allowed during the
REI if it meets the requirements of the no contact exception to WPS (40 CFR 170.112(b)).
Should irrigation equipment need unexpected repairs during the REI, WPS allows workers to
enter a treated field for up to one hour provided early entry PPE is used (40 CFR 170.112(c)).
Based on the Worker Protection Standard, CFR 156.208 (c) 2, if a pesticide triggers a
Toxicity Category I determination for Primary Eye Irritation, an REI of 48 hours is required for
all products. Since endosulfan meets this criteria, a minimum REI of 48 hours is needed for all
endosulfan uses.
56
-------
Table 20. Summary of Mitigation Measures for Occupational and Ecological Risk
Crop*
Risks of Concern
Mitigation
Melons
(1 Ib/ai/A)
Cucumber
(1 Ib/ai/A)
Squash
(1 Ib/ai/A)
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 64 at current REI of 24 hours
MOE = 100at4days
MOE = 86 at 3 days
Risks to non-target aquatic organisms
for WP and EC
Require all wettable powers to be packaged in water soluble bags.
3-day REI for WP (high exposure hand harvesting, pruning,
thinning etc.: MOE = 86)
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2
Ibs./ai/A
Reduce maximum number of applications from 6 per season to 4
per season (except CA where will remain at 3 per season)
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For melons, handler risks are not of concern at the 1 Ib. rate provided engineering controls are employed; that is, water
soluble bags for wettable powder formulations.
Due to the need to re-enter fields often due to frequent harvesting an REI of greater than 3 days is not considered to be
feasible. Endosulfan is an important resistance management tool and is an important element of integrated pest
management programs in some areas especially considering its relatively low impacts on bees. Therefore, the REI is
considered acceptable.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate by 33% and reducing the maximum number of applications per season to four (3 in CA). The
vegetative buffer is designed to reduce the potential for endosulfan to contaminate water through runoff from treated
fields. The 100 ft. spray buffer will also reduce the potential for contamination through spray drift during ground
applications.
Lettuce
(1 Ib./ai/A)
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 64 at current REI of 24 hours
MOE = 100 at 4 days
Risks to non-target aquatic organisms
for WP and EC
Require all wettable powders to be packaged in water soluble bags
4-day REI for WP (high exposure hand harvesting, pruning,
thinning etc.: MOE > 100)
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2
Ibs./ai/A
Reduce maximum number of applications from 3 per season to 2
per season (except CA where will remain at 2 per season)
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
57
-------
Crop*
Risks of Concern
Mitigation
Rationale for Worker Risk Mitigation:
For lettuce, handler risks are not of concern at the 1 Ib. rate provided engineering controls are employed; that is, water
soluble bags for wettable powder formulations.
For lettuce, post-application risks are not of concern at the 1 Ib. rate provided that the REI for the WP formulation is 4
days.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate by 33% and reducing the maximum number of applications per season to two. The vegetative
buffer is designed to reduce the potential for endosulfan to contaminate water through runoff from treated fields. The 100
ft. spray buffer will also reduce the potential for contamination through spray drift during ground applications.
Celery
(1 Ib./ai/A)
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 64 at current REI of 24 hours
MOE = 100at4days
Risks to non-target aquatic organisms
for WP and EC
Require all wettable powders to be packaged in water soluble bags
4-day REI for WP (high exposure hand harvesting, pruning,
thinning etc.: MOE > 100)
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 1
Ibs./ai/A
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For celery, handler risks are not of concern at the 1 Ib. rate provided engineering controls are employed; that is, water
soluble bags for wettable powder formulations.
For celery, post-application risks are not of concern at the 1 Ib. rate provided that the REI for the WP formulation is 4
days.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate by 66%. The vegetative buffer is designed to reduce the potential for endosulfan to contaminate
water through runoff from treated fields. The 100 ft. spray buffer will also reduce the potential for contamination through
spray drift during ground applications.
Apples
(3.01bs/ai/A)
Pears
(3.01bs/ai/A)
Mixing/Loading Liquid for aerial
application
Mixing/Loading WP for aerial
application
Mixing/Loading WP for airblast
application
Application w/ airblast application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 68 at current REI of 24 hours
MOE = 100 at 5 days
Risks to non-target aquatic organisms
for WP and EC
Reduce maximum application rate to 2.5 Ibs./ai/A
Require all wettable powders to be packaged in water soluble bags
Cancel aerial application using the WP formulation
Require closed mixing/loading systems for aerial application using
the EC formulation
Require closed cabs for airblast applications
4-day REI for WP (high exposure hand harvesting, pruning,
thinning etc.: MOE > 100 at 2.5 rate)
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2.5
Ibs./ai/A
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
58
-------
Crop*
Risks of Concern
Mitigation
Rationale for Worker Risk Mitigation:
For apples and pears, handler risks are not of concern at the 2.5 Ib. rate provided that aerial application using WP
products is canceled and engineering controls are employed; that is, water soluble bags for wettable powder formulations,
closed mixing/loading systems are used for aerial applications of EC products and closed cabs are used for airblast
applications (designed to provide dermal protection).
For apples and pears, post-application risks are not of concern at the 2.5 Ib. rate provided that the REI for the WP
formulation is 4 days.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate and the maximum single application rate by 17%. The vegetative buffer is designed to reduce the
potential for endosulfan to contaminate water through runoff from treated fields. The 100 ft. spray buffer will also reduce
the potential for contamination through spray drift during ground applications.
Apricots
(3.01bs./ai/A)
Peaches
(3.01bs./ai/A)
Nectarines
(3.01bs./ai/A)
Plums/Prunes
(3.01bs./ai/A)
Cherries
(3.01bs./ai/A)
Non-Bearing
Citrus
(3.01bs./ai/A)
Mixing/Loading Liquid for aerial
application
Mixing/Loading WP for aerial
application
Mixing/Loading WP for airblast
application
Application w/ airblast application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 68 at current REI of 24 hours
MOE = 100 at 5 days
Risks to non-target aquatic organisms
for WP and EC
Reduce maximum application rate to 2.5 Ibs./ai/A
Require all wettable powders to be packaged in water soluble bags
Cancel aerial application using the WP formulation
Require closed mixing/loading systems for aerial application using
the EC formulation
Require closed cabs for airblast applications
4-day REI for WP (high exposure hand harvesting, pruning,
thinning etc.: MOE > 100 at 2.5 rate)
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2.5
Ibs./ai/A
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For peaches, apricots, nectarines, plums, prunes, cherries and non-bearing citrus, handler risks are not of concern at the
2.5 Ib. rate provided that aerial application using WP products is canceled and engineering controls are employed; that is,
water soluble bags for wettable powder formulations, closed mixing/loading systems are used for aerial applications of
EC products and closed cabs are used for airblast applications (designed to provide dermal protection).
For peaches, apricots, nectarines, plums, prunes, cherries and non-bearing citrus, post-application risks are not of concern
at the 2.5 Ib. rate provided that the REI for the WP formulation is 4 days.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate and the maximum single application rate by 17%. The vegetative buffer is designed to reduce the
potential for endosulfan to contaminate water through runoff from treated fields. The 100 ft. spray buffer will also reduce
the potential for contamination through spray drift during ground applications.
59
-------
Crop*
Risks of Concern
Mitigation
Bark
Treatments
(0.4
Ibs/ai/gal)
Greenhouse
Uses
(0.1
Ibs/ai/gal)
Application with Rights-of-Way
sprayer
Mixing/Loading/Applying with a
high pressure handwand
Reduce maximum application rate to 0.005 Ibs./ai/gal for high
pressure handwand and Rights-of-Way sprayers.
Rationale for Worker Risk Mitigation:
For bark treatment and greenhouse uses, handler risks are not of concern at the 0.005 Ib/ai/gal. rate.
Tomatoes
(1 Ib./ai/A)
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
Risks to non-target aquatic organisms
for WP and EC
Cancel WP use
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2
Ibs./ai/A
Reduce maximum number of applications from 6 per season to 4
per season
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For tomatoes, handler risks are not of concern at the 1 Ib. rate provided that the wettable powder formulation is canceled.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate by 33% and reducing the maximum number of applications per season to four. The vegetative
buffer is designed to reduce the potential for endosulfan to contaminate water through runoff from treated fields. The 100
ft. spray buffer will also reduce the potential for contamination through spray drift during ground applications.
Sweet Corn
(1.51bs/ai/A)
Mixing/Loading Liquid for aerial
application
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting ):
MOE = 10 at current REI of 24 hours
MOE = 100at21days
High exposure activities for EC (hand
harvesting):
MOE = 22 at current REI of 24 hours
MOE = 100 at 17days
Risks to non-target aquatic organisms
for WP and EC
Cancel WP Use
Require closed mixing/loading systems for aerial application using
the EC formulation
17 day REI for EC (hand harvesting: MOE > 100)
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 1.5
Ibs./ai/A
Reduce maximum number of applications from 3 per season to 1
per season
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
60
-------
Crop*
Risks of Concern
Mitigation
Rationale for Worker Risk Mitigation:
For sweet corn, handler risks are not of concern at the 1.5 Ib. rate provided that the wettable powder formulation is
canceled and provided engineering controls are employed; that is closed mixing/loading systems are used for aerial
applications of EC products.
For sweet corn, post-application risks are not of concern at the 1.5 Ib. rate provided the WP formulations are canceled and
that the REI for the EC formulation is 17 days.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate by 50% and reducing the maximum number of applications per season to one. The vegetative
buffer is designed to reduce the potential for endosulfan to contaminate water through runoff from treated fields. The 100
ft. spray buffer will also reduce the potential for contamination through spray drift during ground applications.
Sweet
Potatoes
(2.0 Ibs/ai/A)
Mixing/Loading Liquid for aerial
application
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 32 at current REI of 24 hours
MOE = 100 at 9 days
Medium exposure activities for WP
(scouting and irrigating):
MOE = 54 at current REI of 24 hours
MOE = 100 at 5 days
High exposure activities for EC (hand
harvesting, pruning, thinning etc.):
MOE = 75 at current REI of 24 hours
MOE = 100 at 3days
Risks to non-target aquatic organisms
for WP and EC
Cancel WP Use
Require closed mixing/loading systems for aerial application using
the EC formulation
3 day REI for EC (high exposure activities: MOE > 100)
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2
Ibs./ai/A
Reduce maximum number of applications from 3 per season to 2
per season
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For sweet potatoes, handler risks are not of concern at the 2.0 Ib. rate provided that the wettable powder formulation is
canceled and provided engineering controls are employed; that is closed mixing/loading systems are used for aerial
applications of EC products.
For sweet potatoes, post-application risks are not of concern at the 2.0 Ib. rate provided the WP formulations are canceled
and that the REI for the EC formulation is 3 days.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate by 33% and reducing the maximum number of applications per season to two. The vegetative
buffer is designed to reduce the potential for endosulfan to contaminate water through runoff from treated fields. The 100
ft. spray buffer will also reduce the potential for contamination through spray drift during ground applications.
61
-------
Crop*
Risks of Concern
Mitigation
Collard
Greens (for
seed)
(2.0 Ibs/ai/A)
Kale
(for seed)
(2.0 Ibs/ai/A)
Mustard
Greens
(for seed)
(2.0 Ibs/ai/A)
Radish
(for seed)
(2.0 Ibs/ai/A)
Turnip
(for seed)
(2.0 Ibs/ai/A)
Rutabaga
(for seed)
(2.0 Ibs/ai/A)
Mixing/Loading Liquid for aerial
application
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 32 at current REI of 24 hours
MOE = 100 at 9 days
Medium exposure activities for WP
(scouting and irrigating):
MOE = 54 at current REI of 24 hours
MOE = 100 at 5 days
High exposure activities for EC (hand
harvesting, pruning, thinning etc.):
MOE = 75 at current REI of 24 hours
MOE = 100 at 3days
Risks to non-target aquatic organisms
for WP and EC
Require all wettable powders to be packaged in water soluble bags
Require closed mixing/loading systems for aerial application using
the EC formulation
Cancel aerial application using the WP formulation
5-day REI for WP (scouting and irrigating: MOE > 100)
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For collard greens, kale, mustard greens, radish, rutabaga and turnip (all for seed) handler risks are not of concern at the
2.0 Ib. rate provided engineering controls are employed; that is, water soluble bags for wettable powder formulations,
closed mixing/loading systems are used for aerial applications of EC products, and aerial application using WP products
are canceled.
For collard greens, kale, mustard greens, radish, rutabaga and turnip (all for seed), post-application risks are not of
concern at the 2.0 Ib. rate provided that the REI for the WP formulation is 5 days. Endosulfan is generally applied to
these seed crops at bloom/post bloom. Intensive hand activities such as thinning are expected to have occurred prior to
the time of application and, therefore, high exposure activities are not expected to be relevant for these crops.
Rationale for Ecological Risk Mitigation:
The vegetative buffer is designed to reduce the potential for endosulfan to contaminate water through runoff from treated
fields. The 100 ft. spray buffer will also reduce the potential for contamination through spray drift during ground
applications.
Collard
Greens
(l.Olbs/ai/A)
Kale
(l.Olbs/ai/A)
Mustard
Greens
(l.Olbs/ai/A)
Radish
(l.Olbs/ai/A)
Turnip
(l.Olbs/ai/A)
Rutabaga
(l.Olbs/ai/A)
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 64 at current REI of 24 hours
MOE = 100 at 4 days
Risks to non-target aquatic organisms
for WP and EC
Reduce maximum application rate for kale to 0.75 Ibs/ai/A
Require all wettable powders to be packaged in water soluble bags
4-day REI for WP (hand harvesting, pruning, thinning: MOE >
100)
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
62
-------
Crop*
Risks of Concern
Mitigation
Rationale for Worker Risk Mitigation:
For collard greens, mustard greens, radish, rutabaga and turnip, handler risks are not of concern at the 1.0 Ib. rate and kale
at the 0.75 Ib. rate provided engineering controls are employed; that is, water soluble bags for wettable powder
formulations.
For collard greens, kale, mustard greens, radish, rutabaga and turnip, post-application risks are not of concern at the 1.0
Ib. rate provided that the REI for the WP formulation is 4 days.
Rationale for Ecological Risk Mitigation:
The vegetative buffer is designed to reduce the potential for endosulfan to contaminate water through runoff from treated
fields. The 100 ft. spray buffer will also reduce the potential for contamination through spray drift during ground
applications.
Broccoli
(for seed)
(2.0 Ibs/ai/A)
Cabbage
(for seed)
(2.0 Ibs/ai/A)
Kohlrabi
(for seed)
(2.0 Ibs/ai/A)
Mixing/Loading Liquid for aerial
application
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 16 at current REI of 24 hours
MOE = 100 at 14 days
Medium exposure activities for WP
(scouting and irrigating):
MOE = 20 at current REI of 24 hours
MOE = 100 at 12 days
High exposure activities for EC (hand
harvesting, pruning, thinning etc.):
MOE = 38 at current REI of 24 hours
MOE = 100 at 9days
Medium exposure activities for EC
(scouting and irrigating):
MOE = 47 at current REI of 24 hours
MOE = 100 at 7 days
Risks to non-target aquatic organisms
for WP and EC
Require all wettable powders to be packaged in water soluble bags
Require closed mixing/loading systems for aerial application using
the EC formulation
Cancel aerial application using the WP formulation
12-day REI for WP (scouting and irrigating: MOE > 100)
7-day REI for EC (scouting and irrigating: MOE > 100)
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For broccoli, cabbage and kohlrabi (all for seed) handler risks are not of concern at the 2.0 Ib. rate provided that aerial
application using WP products are canceled and engineering controls are employed; that is, water soluble bags for
wettable powder formulations, closed mixing/loading systems are used for aerial applications of EC products, and aerial
application using WP products are canceled.
For broccoli, cabbage and kohlrabi (all for seed), post-application risks are not of concern at the 2.0 Ib. rate provided that
the REI for the WP formulation is 12 days and for the EC formulations is 7 days. Endosulfan is generally applied to
these seed crops at bloom/post bloom. Intensive hand activities such as thinning are expected to have occurred prior to
the time of application and, therefore, high exposure activities are not expected to be relevant for these crops.
Rationale for Ecological Risk Mitigation:
The vegetative buffer is designed to reduce the potential for endosulfan to contaminate water through runoff from treated
fields. The 100 ft. spray buffer will also reduce the potential for contamination through spray drift during ground
applications.
63
-------
Crop*
Risks of Concern
Mitigation
Broccoli
(2 Ibs/ai/A)
Brussels
Sprouts
(1 Ibs/ai/A)
Cauliflower
(1 Ibs/ai/A)
Cabbage
(2 Ibs/ai/A)
Kohlrabi
(2 Ibs/ai/A)
Mixing/Loading Liquid for aerial
application
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 32 at current REI of 24 hours
MOE = 100 at 9 days (1 Ib. rate)
Medium exposure activities for WP
(scouting and irrigating):
MOE = 40 at current REI of 24 hours
MOE = 100 at 7 days (1 Ib. rate)
High exposure activities for EC (hand
harvesting, pruning, thinning etc.):
MOE = 76 at current REI of 24 hours
MOE = 100 at 4 days (1 Ib. rate)
Medium exposure activities for EC
(scouting and irrigating):
MOE = 94 at current REI of 24 hours
MOE = 100 at 2 days (1 Ib. rate)
Risks to non-target aquatic organisms
for WP and EC
Reduce maximum application rate for broccoli, cabbage and
kohlrabi to 1 Ibs/ai/A
Require all wettable powders to be packaged in water soluble bags
9-day REI for WP (hand harvesting, pruning, thinning etc: MOE >
100)
4-day REI for EC (hand harvesting, pruning, thinning etc: MOE >
100)
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2
Ibs./ai/A
Reduce maximum number of applications from 4 per season to 2
per season (CA remains at 2)
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For broccoli, brussels sprout, cauliflower, cabbage and kohlrabi, handler risks are not of concern at the 1.0 Ib. rate
provided engineering controls are employed; that is water soluble bags for wettable powder formulations.
For broccoli, brussels sprout, cauliflower, cabbage and kohlrabi, post-application risks are not of concern at the 1.0 Ib.
rate provided that the REI for the WP formulation is 9 days and for the EC formulation is 4 days.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum application rate by 50% for broccoli, cabbage and kohlrabi, the maximum seasonal rate by 33% for each
commodity and reducing the maximum number of applications per season to two. The vegetative buffer is designed to
reduce the potential for endosulfan to contaminate water through runoff from treated fields. The 100 ft. spray buffer will
also reduce the potential for contamination through spray drift during ground applications.
64
-------
Crop*
Risks of Concern
Mitigation
Cotton
(2 Ibs/ai/A)
Mixing/Loading Liquid for aerial
application
Mixing/Loading WP for aerial
application
Application with aerial equipment
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 16 at current REI of 24 hours
MOE = 100 at 14 days
Medium exposure activities for WP
(scouting and irrigating):
MOE = 20 at current REI of 24 hours
MOE = 100 at 12 days
High exposure activities for EC (hand
harvesting, pruning, thinning etc.):
MOE = 38 at current REI of 24 hours
MOE = 100 at 9 days
Risks to non-target aquatic organisms
for WP and EC
Cancel WP use
Reduce rate for ground application to 1.5 Ibs/a/A
Reduce rate for aerial application to 0.75 Ibs/ai/A
Require closed mixing/loading systems for aerial application using
the EC formulation
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2
Ibs./ai/A (ground)
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 1.5
Ibs./ai/A (aerial)
Reduce maximum number of applications from 6 per season to 2
per season
Restrict use on cotton to the following states: AZ. CA, NM, OK,
and TX.
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For cotton, handler risks are not of concern at the 1.5 Ib. rate (ground) and the 0.75 Ib. rate (aerial) provided engineering
controls are employed; that is closed mixing/loading systems are used for aerial applications of EC products.
Post harvest risks are not of concern provided that labels state that only mechanical harvesting is allowed and hand
thinning/pruning is prohibited.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum application rate by 25% for ground applications and 63% for aerial applications, the maximum seasonal rate by
33% (ground) and 50% (aerial), and reducing the maximum number of applications per season to two. The vegetative
buffer is designed to reduce the potential for endosulfan to contaminate water through runoff from treated fields. The 100
ft. spray buffer will also reduce the potential for contamination through spray drift during ground applications.
By restricting the use on cotton to AZ, CA, NM, OK and TX exposures to aquatic organisms are expected to be reduced.
These restrictions remove use in areas of the country where water resources are more abundant and potentially
vulnerable.
65
-------
Crop*
Risks of Concern
Mitigation
Blueberries
(2 Ibs/ai/A)
Mixing/Loading Liquid for aerial
application
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 16 at current REI of 24 hours
MOE = 100 at 14 days
Medium exposure activities for WP
(scouting and irrigating):
MOE = 81 at current REI of 24 hours
MOE = 100 at 3 days
High exposure activities for EC (hand
harvesting, pruning, thinning etc.):
MOE = 38 at current REI of 24 hours
MOE = 100 at 9 days
Risks to non-target aquatic organisms
for WP and EC
Reduce the maximum application rate to 1.5 Ibs/ai/A
Require all wettable powders to be packaged in water soluble bags
Require closed mixing/loading systems for aerial application using
the EC formulation
Cancel aerial application using the WP formulation
9 day REI for WP (high exposure activities, hand harvesting ,
pruning, thinning etc.: MOE > 100)
6 day REI for EC (high exposure activities, hand harvesting ,
pruning, thinning etc.: MOE > 100)
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 1.5
Ibs./ai/A
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For blueberry, handler risks are not of concern at the 1.5 Ib. rate provided that aerial application using WP products is
canceled and engineering controls are employed; that is, water soluble bags for wettable powder formulations, closed
mixing/loading systems are used for aerial applications of EC products and aerial application using WP products are
canceled.
For blueberry, post-application risks are not of concern at the 1.5 Ib. rate provided that the REI for the WP formulation is
9 days and the REI for the EC formulation is 6 days. Since this use is primarily a post-harvest use increasing the REI is
not expected to have an impact on use.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum application rate by 25% and reducing the maximum seasonal rate by 50%. The vegetative buffer is designed to
reduce the potential for endosulfan to contaminate water through runoff from treated fields. The 100 ft. spray buffer will
also reduce the potential for contamination through spray drift during ground applications.
Strawberry
(2.0 Ibs/ai/A)
Mixing/Loading Liquid for aerial
application
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 54 at current REI of 24 hours
MOE = 100 at 5 days
Risks to non-target aquatic organisms
for WP and EC
Reduce the maximum application rate to 1 Ibs/ai/A
Require all wettable powders to be packaged in water soluble bags
Require closed mixing/loading systems for aerial application using
the EC formulation
Cancel aerial application using the WP formulation
5 day REI for WP (high exposure activities, hand harvesting ,
pruning, thinning etc.: MOE > 100)
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2
Ibs./ai/A
Reduce maximum number of applications from 3 per season to 2
per season
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
66
-------
Crop*
Risks of Concern
Mitigation
Rationale for Worker Risk Mitigation:
For strawberry, handler risks are not of concern at the 1 Ib. rate provided that aerial application using WP products is
canceled and engineering controls are employed; that is, water soluble bags for wettable powder formulations, closed
mixing/loading systems are used for aerial applications of EC products and aerial application using WP products are
canceled.
For strawberry, post-application risks are not of concern at the 1 Ib. rate provided the REI for the WP formulation is 5
days.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum application rate by 50%, reducing the maximum seasonal rate by 33% and reducing the maximum number of
applications per season to two. The vegetative buffer is designed to reduce the potential for endosulfan to contaminate
water through runoff from treated fields. The 100 ft. spray buffer will also reduce the potential for contamination through
spray drift during ground applications.
Alfalfa (seed)
(1 Ib/ai/A)
Mixing/Loading Liquid for aerial
application
Mixing/Loading WP for aerial
application
Application with aerial equipment
Risks to non-target aquatic organisms
for WP and EC
Cancel WP Use
Reduced application rate to llb/ai/A
Require closed mixing/loading systems for aerial application
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For alfalfa (seed), handler risks are of concern at the 1.0 Ib. rate even provided that wettable powder formulations are
canceled and provided engineering controls are employed; that is closed mixing/loading systems are used for aerial
applications of EC products (MOE = 82).
In California, the seed alfalfa acreage has decreased significantly to approximately 20,000 to 35,000 acres Endosulfan
use in seed alfalfa is part of an integrated management approach that also benefits cotton producers. The use of
endosulfan, when combined with a pyrethroid, is important in the control ofLygus bugs. Since seed alfalfa is harvested
earlier than cotton, there is potential for Lygus bugs to migrate into cotton fields later in the season. Use of sublethal
doses of pyrethroid alone could result in resistance and the lower endosulfan rate may be insufficient to guarantee good
coverage, especially under heavy infestations or over time. Resistance, which has been observed in other crops, hinders
control with another pyrethroid application, the usual method of treatment, and would require use of potentially harsher
alternatives. Relatively few other alternatives are available to alfalfa growers. Compared to those that are registered,
including the organophosphates, malathion and dimethoate, endosulfan is less toxic to honey bees, which are crucial to
the pollination of the alfalfa crop. Lygus bugs can also migrate to other crops, including dry beans. The Agency
considers this use to be beneficial to both seed alfalfa and cotton growers in California, and minimizes resistance issues
that would arise from sole reliance on pyrethroids.
In Washington, Oregon, Idaho, and Nevada, the Agency believes that it is unlikely that 1200 acres would be treated in a
given day. For instance, in eastern Oregon and southwest Idaho, seed alfalfa fields are usually about 5 to 20 acres in size,
while the average farm size in Oregon was 114 acres in 1997. The spotted alfalfa aphid is the main pest treated.
Endosulfan applications are generally needed only once per season when there is an outbreak, which may not occur
simultaneously on all fields. Endosulfan is used at a range of rates, with lower rates being used at night during bloom to
protect bees and at higher rates if the outbreak occurs later in the season. There are concerns that using lower rates of
endosulfan for the spotted alfalfa aphid would not result in adequate control and would lead to resistance problems in the
future. Given relatively few registered alternatives on alfalfa for seed, this is a plausible scenario.
Given the benefits and the characterization of likely acres treated per day presented above, the Agency believes no further
mitigation is necessary at this time for alfalfa (seed).
67
-------
Crop*
Risks of Concern
Mitigation
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum application rate by 25%. The vegetative buffer is designed to reduce the potential for endosulfan to
contaminate water through runoff from treated fields. The 100 ft. spray buffer will also reduce the potential for
contamination through spray drift during ground applications.
Small Grains
(0.75
Ibs/ai/A)
Mixing/Loading Liquid for aerial
application
Mixing/Loading WP for aerial
application
Application with aerial equipment
Risks to non-target aquatic organisms
for WP and EC
Cancel WP Use
Require closed mixing/loading systems for aerial application using
the EC formulation
Reduce maximum number of applications from 2 per season to 1
per season
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For small grains, handler risks are not of concern at the 0.75 Ib. rate provided that wettable powder formulations are
canceled and provided engineering controls are employed; that closed mixing/loading systems are used for aerial
applications of EC products..
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum number of applications rate by 50%. The vegetative buffer is designed to reduce the potential for endosulfan
to contaminate water through runoff from treated fields. The 100 ft. spray buffer will also reduce the potential for
contamination through spray drift during ground applications.
Filberts
(2 Ibs/ai/A)
Walnuts
(2 Ibs/ai/A)
Almonds
(2 Ibs/ai/A)
Macadamia
Nuts
(2 Ibs/ai/A)
Mixing/Loading Liquid for aerial
application
Mixing/Loading WP for aerial
application
Mixing/Loading WP for airblast
application
Application w/ airblast application
Risks to non-target aquatic organisms
for WP and EC
Require all wettable powders to be packaged in water soluble bags
Cancel aerial application using the WP formulation
Require closed mixing/loading systems for aerial application using
the EC formulation
Require closed cabs for airblast applications
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2
Ibs./ai/A
Reduce maximum number of applications from 2 per season to 1
per season
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
68
-------
Crop*
Risks of Concern
Mitigation
Rationale for Worker Risk Mitigation:
For filberts and walnuts, handler risks are not of concern at the 2 Ib. rate provided engineering controls are employed; that
is, water soluble bags for wettable powder formulations, closed mixing/loading systems are used for aerial applications of
EC products, aerial application using WP products are canceled and closed cabs are used for airblast applications
(designed to provide dermal protection).
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate by 33% and the maximum number of applications to one. The vegetative buffer is designed to
reduce the potential for endosulfan to contaminate water through runoff from treated fields. The 100 ft. spray buffer will
also reduce the potential for contamination through spray drift during ground applications.
Peppers
(1 Ibs/ai/A)
Eggplant
(1 Ibs/ai/A)
Mixing/Loading WP for aerial
application
Mixing/Loading WP for airblast
application
Risks to non-target aquatic organisms
for WP and EC
Require all wettable powders to be packaged in water soluble bags
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2
Ibs./ai/A
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For eggplant and peppers, handler risks are not of concern at the 1 Ib. rate provided engineering controls are employed;
that is, water soluble bags for wettable powder formulations.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate by 33%. The vegetative buffer is designed to reduce the potential for endosulfan to contaminate
water through runoff from treated fields. The 100 ft. spray buffer will also reduce the potential for contamination through
spray drift during ground applications.
Potatoes
(1 Ibs/ai/A)
Mixing/Loading WP for aerial
application
Mixing/Loading WP for airblast
application
Risks to non-target aquatic organisms
for WP and EC
Require all wettable powders to be packaged in water soluble bags
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2
Ibs./ai/A
Reduce maximum number of applications from 6 per season to 4
per season
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For potatoes, handler risks are not of concern at the 1 Ib. rate provided engineering controls are employed; that is, water
soluble bags for wettable powder formulations.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate by 33% and the maximum number of applications to 4. The vegetative buffer is designed to
reduce the potential for endosulfan to contaminate water through runoff from treated fields. The 100 ft. spray buffer will
also reduce the potential for contamination through spray drift during ground applications.
69
-------
Crop*
Risks of Concern
Mitigation
Carrots
(1 Ibs/ai/A)
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 54 at current REI of 24 hours
MOE = 100 at 5 days
Risks to non-target aquatic organisms
for WP and EC
Cancel WP use
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2
Ibs./ai/A
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For carrots, handler risks are not of concern at the 1 Ib. rate provided that the wettable powder use is canceled.
For carrots, post-application risks are not of concern at the 1 Ib. rate provided the WP formulations are canceled.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate by 33%. The vegetative buffer is designed to reduce the potential for endosulfan to contaminate
water through runoff from treated fields. The 100 ft. spray buffer will also reduce the potential for contamination through
spray drift during ground applications.
Dry Beans
(1 Ibs/ai/A)
Dry Peas
(1 Ibs/ai/A)
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 65 at current REI of 24 hours
MOE = 100 at 4 days
Risks to non-target aquatic organisms
for WP and EC
Cancel WP use
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2
Ibs./ai/A
Reduce maximum number of applications from 3 per season to 2
per season
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For dry beans and dry peas, handler risks are not of concern at the 1 Ib. rate provided that the wettable powder use is
canceled.
For dry beans and dry peas, post-application risks are not of concern at the 1 Ib. rate provided the WP formulations are
canceled.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate by 33% and the maximum number of applications to two. The vegetative buffer is designed to
reduce the potential for endosulfan to contaminate water through runoff from treated fields. The 100 ft. spray buffer will
also reduce the potential for contamination through spray drift during ground applications.
70
-------
Crop*
Risks of Concern
Mitigation
Tobacco
(1 Ib/ai/A)
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 54 at current REI of 24 hours
MOE = 100at4days
Medium exposure activities for WP
(scouting and irrigating):
MOE = 83 at current REI of 24 hours
MOE = 100 at 2 days
Risks to non-target aquatic organisms
for WP and EC
Cancel WP use
Reduce maximum seasonal application rate from 3 Ibs./ai/A to 2
Ibs./ai/A
Reduce maximum number of applications from 6 per season to 2
per season
Restrict use on tobacco to the following states: IN, KY, OH, PA,
TN and WV.
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For tobacco, handler risks are not of concern at the 1 Ib. rate provided that the wettable powder use is canceled.
For tobacco, post-application risks are not of concern at the 1 Ib. rate provided the WP formulations are canceled.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum seasonal rate by 33% and the maximum number of applications to two. The vegetative buffer is designed to
reduce the potential for endosulfan to contaminate water through runoff from treated fields. The 100 ft. spray buffer will
also reduce the potential for contamination through spray drift during ground applications.
By restricting the use on tobacco to IN, KY, OH, PA, TN and WV exposures to aquatic organisms are expected to be
reduced. These restrictions remove use in areas of the country where water resources are more abundant and potentially
vulnerable.
Pineapple
(2 Ibs/ai/A)
Mixing/Loading WP for aerial
application
Mixing/Loading WP for ground
application
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 81 at current REI of 24 hours
MOE = 100 at 3 days
Risks to non-target aquatic organisms
for WP and EC
Cancel WP use
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
71
-------
Crop*
Risks of Concern
Mitigation
Rationale for Worker Risk Mitigation:
For pineapple, handler risks are not of concern at the 2 Ib. rate provided that the wettable powder use is canceled.
For pineapple, post-application risks are not of concern at the 2 Ib. rate provided the WP formulations are canceled.
Rationale for Ecological Risk Mitigation:
The vegetative buffer is designed to reduce the potential for endosulfan to contaminate water through runoff from treated
fields. The 100 ft. spray buffer will also reduce the potential for contamination through spray drift during ground
applications.
Ornamental
Trees/Shrubs
(3 Ibs/ai/A)
High exposure activities for WP
(hand harvesting, pruning, thinning
etc.):
MOE = 68 at current REI of 24 hours
MOE = 100 at 5 days
Risks to non-target aquatic organisms
for WP and EC
Require all wettable powders to be packaged in water soluble bags
Reduce maximum application rate to 2.5 Ibs/ai/A
4-day REI (high exposure hand harvesting, pruning, thinning etc.:
MOE > 100)
100 ft. spray buffer for ground applications between a treated area
and water bodies
30 ft. maintained vegetative buffer strip between a treated area and
water bodies
Rationale for Worker Risk Mitigation:
For ornamental trees and shrubs, post-application risks are not of concern at the 2.5 Ib. rate provided that the REI for the
WP formulation is 4 days.
Rationale for Ecological Risk Mitigation:
Overall environmental loading and, therefore, exposure to non-target organisms will be reduced by reducing the
maximum single application rate by 17%. The vegetative buffer is designed to reduce the potential for endosulfan to
contaminate water through runoff from treated fields. The 100 ft. spray buffer will also reduce the potential for
contamination through spray drift during ground applications.
* Rates in parentheses are the rates used in the risk assessment. Unless otherwise noted, these correspond to the maximum
application rate to be allowed on labels.
2. Environmental Risk Mitigation
The Agency has ecological risk concerns regarding the acute and chronic risks to
terrestrial birds and mammals, freshwater fish, freshwater invertebrates, estuarine/marine fish
and estuarine/marine invertebrates. The ecological risk assessments exhibit RQ values which
exceed the various target levels of concern (LOCs). As outlined in Section III above, risks are
much higher, as evidenced by higher RQ values, for aquatic organisms, and especially for
estuarine/marine organisms.
Birds and Mammals
The Agency's assessment suggests the potential for the liquid formulation to cause acute
and chronic effects to birds and mammals for broadcast applications. The avian acute RQs range
from 0.02 to 0.53. The avian chronic RQs range from 0.03 to 2.7. For the same use patterns,
mammalian acute RQs range from 0.06 to 40 while mammalian chronic RQs range from 0.3 to
5.4. The highest avian and mammalian RQs result from twol.5 Ib ai/A ground or aerial
72
-------
applications to several crops. Most use patterns are of concern to the Agency for acute and
chronic effects to birds and mammals.
Because of the toxicity of endosulfan, to help protect terrestrial birds and mammals, it is
very important to minimize their potential exposure. To minimize risk to birds and mammals,
several mitigation measures are needed as outlined in Table 20 above. These measures include
reductions in single maximum application rates, reductions in maximum seasonal application
rates, reductions in maximum numbers of applications allowed in a single growing season and
the deletion of use on pecans, succulent beans, succulent peas, grapes and spinach.
Aquatic Organisms
At the current maximum application rates used on the major crops where endosulfan is
employed, coupled with a 300-ft spray drift buffer, acute high risk, restricted use and
endangered species levels of concern are exceeded for both freshwater and estuarine/marine
organisms. Acute RQ values ranged from 1.04 to 34.8 for freshwater fish and from 0.15 to 5 for
freshwater invertebrates. Estuarine/marine fish and invertebrates were roughly an order of
magnitude more sensitive to the effects of endosulfan, with acute RQ values ranging from 8.7 to
289 for fish and 1.9 to 64.2 for invertebrates. Chronic RQ values ranged from 1.5 to 64 for
freshwater fish and from 3.6 to 135.3 for freshwater invertebrates. Chronic RQ values for
estuarine/marine fish ranged from 16 to 704 and 1 to 39.5 for estuarine/marine invertebrates.
The highest aquatic RQs result from three 1.0 Ib ai/A applications to tomatoes. All use patterns
are of concern to the Agency for acute and chronic effects to aquatic organisms.
Because of the toxicity of endosulfan, to help protect aquatic organisms, it is very
important to minimize their potential exposure to endosulfan products that have been applied. To
reduce risk to aquatic organisms, several mitigation measures are needed as outlined in Table 20
above. These measures include deletion of use on pecans, succulent beans, succulent peas,
grapes and spinach, reductions in single maximum application rates, maximum seasonal
application rates and maximum numbers of applications allowed in a single growing season.
They also include implementing a 100 foot setback from water bodies for ground applications
and a 30 foot maintained vegetative buffer between treated fields and water bodies.
3. Public Comment and Stakeholder Process to Address Aquatic Risks
and Long Range Transport
Given the toxicity and persistence of endosulfan and potential risks to aquatic organisms,
the Agency has developed a number of mitigation measures to reduce the risks to aquatic
organisms outlined in this document. While the Agency believes that these measures will reduce
the potential for exposures to aquatic organisms and reduce the overall environmental loading of
endosulfan, it also believes that in specific geographical areas where conditions exist that make
aquatic organisms especially vulnerable (e.g. shallow, leaky aquifers, highly erodible lands, the
presence of especially sensitive organisms and high use of endosulfan) additional measures may
be identified. In order to more fully evaluate the risks in these vulnerable areas; the risk
73
-------
management strategies that may be in place or could potentially be implemented in such areas
(e.g. use of retention ponds) to reduce exposure; and the benefits of the use of endosulfan in
those areas, the Agency is planning to conduct a public comment and stakeholder process.
During the public comment period, commencing with the publishing of a Federal
Register Notice, comments and suggestions will be collected and reviewed concerning risks to
aquatic organisms in vulnerable areas, risk management strategies for addressing those risks and
the benefits of use of endosulfan in vulnerable areas. Further, a stakeholder meeting(s) will be
held within 3 months for the issuance of this RED at a location(s) to be determined. For this
meeting(s) to be most efficient and successful, all interested parties and viewpoints will be
welcomed and considered.
Endosulfan is a semivolatile and persistent cyclodiene pesticide that can migrate over a
long distance through various environmental media such as air, water, and sediment. Once
endosulfan is applied to crops, it can either persist in soil as a sorbed phase or be removed
through several physical, chemical, and biological processes. Recent studies suggest that
secondary emissions of residual endosulfan continue to recycle in the global system while they
slowly migrated and are redeposited via wet deposition in the Northern Hemisphere. The
occurrence of endosulfan in remote regions like the Great Lakes, the Arctic, and mountainous
areas is well documented. Endosulfan can also enter the air as adsorbed phase onto suspended
particulate matter, but this process does not appear to be a major contributor long range transport
like volatilization.
The presence of endosulfan in the remote areas like the Arctic and the Great Lakes
requires further understanding of the transport mechanisms from the atmosphere. The potential
impact of atmospheric deposition of endosulfan into surface water and its potential effect on
water quality and aquatic organisms in the non-use areas is not well documented. Despite the
progress made in recent years in estimating the persistence and long-ranged transport of
chemicals using models, a validated global model has not been published because of
uncertainties involved in the source inventories, chemical fate data, degradative pathways and
exposure analyses. Future work will be aimed at developing a comprehensive screening tool that
can be used reliably in risk assessments for regulatory purposes. Part of the stakeholder process
will include an evaluation of to what extent data related to long range transport may be
necessary.
E. Other Labeling
Other use and safety information needs to be placed on the labeling of all end-use
products containing endosulfan. For the specific labeling statements, refer to Section V of this
document
1. Endangered Species Statement
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on endangered and threatened species, and to
74
-------
implement mitigation measures that address these impacts. The Endangered Species Act
requires federal agencies to ensure that their actions are not likely to jeopardize listed species or
adversely modify designated critical habitat. To analyze the potential of registered pesticide
uses to affect any particular species, EPA puts basic toxicity and exposure data developed for
REDs into context for individual listed species and their locations by evaluating important
ecological parameters, pesticide use information, the geographic relationship between specific
pesticide uses and species locations, and biological requirements and behavioral aspects of the
particular species. This analysis will take into consideration any regulatory changes
recommended in this RED that are being implemented at this time.
The Agency will begin an endangered species effects determination process for all uses
of endosulfan that remain registered following completion of the RED. Through this effects
determination the Agency will develop use limitations and/or consult with the Fish and Wildlife
Service and/or the National Marine Fisheries Service where appropriate.
The Endangered Species Protection Program as described in a Federal Register notice (54
FR 27984-28008, July 3, 1989) is currently being implemented on an interim basis. As part of
the interim program, the Agency has developed County Specific Pamphlets that articulate many
of the specific measures outlined in the Biological Opinions issued to date. The Pamphlets are
available for voluntary use by pesticide applicators on EPA's website at http://www.epa.gov/espp.
A final Endangered Species Protection Program, which may be altered from the interim program,
will soon be proposed for public comment in the Federal Register.
2. Spray Drift Management
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices,
State Lead Agencies for pesticide regulation, and other parties to develop the best spray drift
management practices. The Agency has completed its evaluation of the new database submitted
by the Spray Drift Task Force and is developing policy on how to appropriately apply the data
and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard
airblast, or ground hydraulic spray. After the policy is in place, the Agency may impose further
refinements in spray drift management practices to reduce off-target drift and risks associated
with aerial application or other application methods associated with drift, where appropriate.
Based on these analyses, the Agency is in the process of developing more appropriate
label statements for spray, and dust drift control to ensure that public health, and the
environment are protected from unreasonable adverse effects. In August 2001, EPA published
draft guidance for label statements in a pesticide registration (PR) notice ("Draft PR Notice
2001-X" http://www.epa.gov/ PR_Notices/#2001). A Federal Register notice was published on
August 22, 2001 (http://www.epa.gov/fedrgstr) announcing the availability of this draft guidance
for a 90-day public comment period. After review of the comments, the Agency will publish
final guidance in a PR notice for registrants to use when labeling their products.
75
-------
In the interim, registrants may choose to use the proposed statements. Registrants should
read and refer to the draft PR notice to obtain a full understanding of the proposed guidance and
its intended applicability, exemptions for certain products, and the Agency's willingness to
consider other versions of the statements.
Registrants may elect to adopt the appropriate sections of the proposed language below,
or a version that is equally protective, for their end-use product labeling for the purpose of
complying with the deadlines for label submission outlined in this document. The proposed
label language is as follows:
For products applied outdoors as liquids:
"Do not allow spray to drift from the application site and contact people, structures
people occupy at any time and the associated property, parks and recreation areas,
nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals."
"For ground boom applications, apply with nozzle height no more than 4 feet above the
ground or crop canopy, and when wind speed is 10 mph or less at the application site as
measured by an anemometer. Use (registrant to fill in blank with spray quality,
e.g. fine or medium) or coarser spray according to ASAE 572 definition for standard
nozzles or VMD for spinning atomizer nozzles."
"For aerial applications, the boom width must not exceed 75% of the wingspan or 90% of
the rotary blade. Use upwind swath displacement, and apply only when wind speed is 3 -
10 mph as measured by an anemometer. Use (registrant to fill in blank with spray
quality, e.g. fine or medium) or coarser spray according to ASAE 572 definition for
standard nozzles or VMD for spinning atomizer nozzles. If application includes a no-
spray zone, do not release spray at a height greater than 10 feet above the ground or the
crop canopy."
For overhead chemigation:
"Apply only when wind speed is 10 mph or less."
On all product labels:
"The applicator also must use all other measures necessary to control drift."
"For ground rig applications, apply product no more than 4 feet above the ground
or the crop canopy, and only when wind speed is 10 mph or less at the application
site as measured by an anemometer."
"For aerial applications, use upwind swath displacement, and apply only when wind
speed is 3 - 10 mph as measured by an anemometer. If application includes a no-spray
76
-------
zone, do not release dust at a height greater than 10 feet above the ground or the crop
canopy."
Or
"The applicator also must use all other measures necessary to control drift."
For hand-applied products to be applied as sprays:
"Do not allow spray or dust to drift from the application site, and contact people,
structures people occupy at any time, and the associated property, parks and recreation
areas, nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or
animals. Apply only when wind speed is not more than 10 mph. For sprays, apply
largest size droplets possible."
Alternatively, registrants may elect to use the following language, which is the current
Agency policy on drift labeling:
For products that are applied outdoors in liquid sprays (except mosquito adulticidesl
regardless of application method, the following must be added to the labels:
"Do not allow this product to drift."
The Agency recognizes that the above option does not address other application types.
Registrants may therefore wish to adapt some variation of the old, and proposed new language
for their particular products, depending on their application methods.
V. What Registrants Need to Do
The Agency has determined that agricultural use of endosulfan, based on the currently
approved labeling, pose occupational and ecological risks that constitute unreasonable adverse
effects on the environment. However, the Agency believes that these risks can likely be
acceptably mitigated through routine changes to pesticide labeling and formulations.
Accordingly, the Agency has determined that endosulfan is eligible for reregi strati on provided
that: (i) additional data that the Agency intends to require confirm this decision for occupational
exposures associated with the application of dip treatment to roots or whole plants and ecological
risks; and (ii) the risk mitigation measures outlined in this document are adopted, and label
amendments are made to reflect these measures. To implement the risk mitigation measures, the
registrants must amend their product labeling to incorporate the label statements set forth in the
Label Summary Table in Section E below. The additional data requirements that the Agency
intends to obtain will include, among other things, submission of the following:
77
-------
A. Data Call-In Responses
For endosulfan technical grade active ingredient products, registrants need
to submit the following items.
Within 90 days from receipt of the generic data call-in (DCI):
(1) completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
(2) submit any time extension and/or waiver requests with a full written
justification.
Within the time limit specified in the generic DCI:
(1) cite any existing generic data which address data requirements or submit
new generic data responding to the DCI.
Please contact Stacey Milan at (703) 305-2505 with questions regarding generic
reregi strati on and/or the DCI. All materials submitted in response to the generic DCI should be
addressed:
By US mail: By express or courier service:
Document Processing Desk (DCI/SRRD) Document Processing Desk (DCI/SRRD)
Stacey Milan Stacey Milan
US EPA (7508C) Office of Pesticide Programs (7508C)
1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2
Washington, DC 20460 1921 Jefferson Davis Highway
Arlington, VA 22202
B. For products containing the active ingredient endosulfan. registrants need to
submit the following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
1. Completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
2. Submit any time extension or waiver requests with a full written
justification.
Within eight months from the receipt of the PDCI:
78
-------
a. two copies of the confidential statement of formula (EPA Form
570-4);
b. a completed original application for reregi strati on (EPA Form
8570-1). Indicate on the form that it is an "application for
reregi strati on";
c. five copies of the draft label incorporating all label amendments
outlined in Table 21 of this document;
d. a completed form certifying compliance with data compensation
requirements (EPA Form 8570-34);
e. if applicable, a completed form certifying compliance with cost
share offer requirements (EPA Form 8570-32); and
f. the product-specific data responding to the PDCI.
Please contact Karen Jones at (703) 308 - 8047 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed:
By US mail: By express or courier service only:
Document Processing Desk (PDCI/PRB) Document Processing Desk (PDCI/PRB)
Karen Jones Karen Jones
US EPA (7508C) Office of Pesticide Programs (7508C)
1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2
Washington, DC 20460 1921 Jefferson Davis Highway
Arlington, VA 22202
B. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of endosulfan for the above uses has
been reviewed and determined to be substantially complete with the exception of the following
studies. The following data requirements are necessary to confirm the reregi strati on eligibility
decision documented in this RED.
Studies on endosulfan sulfate
1. OPPTS 850.2100: Avian acute oral toxicity of bobwhite quail and mallard duck.
2. OPPTS 850.2200: Avian subchronic oral toxicity of bobwhite quail and mallard duck.
3. OPPTS 850.2300: Avian reproduction study of bobwhite quail and mallard duck
79
-------
4. OPPTS 850.1075: Freshwater fish acute toxicity study of bluegill sunfish.
5. OPPTS 850.1500: Freshwater fish full life cycle using rainbow trout.
6. OPPTS 850.1075: Estuarine/marine fish acute toxicity study.
7. OPPTS 850.1035: Estuarine/marine invertebrate acute toxicity study of mysid shrimp
8. OPPTS 850.1300: Early life stage fish
9. OPPTS 850.1350: Life cycle invertebrate
Other Studies
1. OPPTS 850.1735: Whole sediment acute toxicity testing using a freshwater invertebrate.
2. OPPTS 850.1740: Whole sediment acute toxicity testing using a estuarine/marine
invertebrate.
3. OPPTS 850.1735S: Whole sediment chronic toxicity testing using a freshwater invertebrate.
4. OPPTS 850.1740S: Whole sediment chronic toxicity testing using an estuarine/marine
invertebrate.
5. 164-2 (Special Study): Vegetative buffer effectiveness study
6. OPPTS 835.7100: Groundwater monitoring study
7. OPPTS 835.7200: Surface drinking water monitoring study
8. OPPTS 870.6200: Subchronic Neurotoxicity - Rat
9. OPPTS 870.6300: Developmental Neurotoxicity Toxicity Study - Rat
10. OPPTS 860.1380: Storage stability (oils seed, non-oily grain and processed commodities)
11. OPPTS 860.1900: Field rotational crop study
12. OPPTS 860.1500: Crop field trials for the following raw agricultural commodities: barley
hay, and pearled barley; oat forage, hay, and rolled oats; rye forage; wheat forage, and hay.
13. OPPTS 860.1500: Crop field trials for tobacco and a pyrolysis.
14. OPPTS 860.1520: Magnitude of residue in processed food/feed commodities
15. OPPTS 875.1100: Dermal outdoor exposure for applying dip treatments to trees and roots
or whole plants.
16. OPPTS 875.1700: Product use information for applying dip treatments to trees and roots or
whole plants.
2. Labeling for Manufacturing Use Products
To remain in compliance with FIFRA, manufacturing use product (MUP) labeling should
be revised to comply with all current EPA regulations, PR Notices and applicable policies. The
MP labeling should bear the labeling contained in Table 21 at the end of this section.
C. 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. Registrants must
review previous data submissions to ensure that they meet current EPA acceptance criteria and if
80
-------
not, commit to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product. A product-specific data call-in, outlining specific data requirements, accompanies this
RED.
2. Labeling for End-Use Products
Labeling changes are necessary to implement the mitigation measures outlined in Section
IV above. Specific language to incorporate these changes is specified in the Table 21 at the end
of this section.
D. Existing Stocks
The Agency has determined that registrant may distribute and sell endosulfan products
bearing old labels/labeling for 9 months from the date of issuance of this RED. Persons other
than the registrant may distribute or sell such products for 18 months from the date of the
issuance of this RED. Registrants and persons other than the registrant remain obligated to meet
pre-existing label requirements and existing stocks requirements applicable to products they sell
or distribute.
E. Labeling Changes Summary Table
In order to mitigate the risks identified in this document, amend all product labels to
incorporate the risk mitigation measures outlined in Section IV. The following table describes
how language on the labels should be amended.
81
-------
Table 21. Summary of Labeling Changes for Endosulfan
Description
I
Labeling
Placement on Label
Manufacturing-Use Products
'ormulation instructions
required for all MUP labels.
'Only for formulation into an insecticide for the following use(s)" [fill blank only with those uses that are being
supported byMP registrant}.
Directions for Use
3ne of these statements may be
idded to a label to allow
•eformulation of the product for
i specific use or all additional
ises supported by a formulator
)r user group.
This product may be used to formulate products for specific use(s) not listed on the MP label if the formulator, user
;roup, or grower has complied with U.S. EPA submission requirements regarding support of such use(s)."
'This product may be used to formulate products for any additional use(s) not listed on the MP label if the formulator,
iser group, or grower has complied with U.S. EPA submission requirements regarding support of such use(s)."
Directions for Use
Environmental Hazards
statements Required by the
IED and Agency Label Policies
•Environmental Hazards"
'Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless
n accordance with the requirements of a National Pollutant Discharge Elimination System (NDPES) permit and the
permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to
iewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your
Water Board or Regional Office of the EPA."
'This product is extremely toxic to fish and aquatic invertebrates and toxic to birds and mammals. Do not apply
lirectly to water, or to areas where surface water is present, or to intertidal areas below the mean high water mark.
Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas. See Spray drift
management instructions under "Directions for use. Do not contaminate water when disposing of equipment wash
waters or rinsate."
"recautionary Statements
End-Use Products Intended for Occupational Use
Handler PPE Guidelines (all
Simulations)
the following information when preparing labeling for all end use products:
'or sole-active-ingredient end-use products that contain Endosulfan, the product label must be revised to adopt the
landler personal protective equipment (PPE)/engineering control requirements set forth in this section. Any
;onflicting PPE requirements on the current label must be removed.
'or multiple-active-ingredient end-use products that contain Endosulfan, the handler PPE/engineering control
•equirements set forth in this section must be compared with the requirements on the current label, and the more
protective language must be retained. For guidance on which requirements are considered to be more protective, see
Notice 93-7.
DPE that will be established on the basis of Acute Toxicity testing on end-use products undergoing product
reregistration must be compared with the active ingredient PPE specified below by the RED. The more protective PPE
must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-
17.
Handler PPE Statements
82
-------
Description
Labeling
Placement on Label
IUP Statement
Required for All Formulations
'RESTRICTED USE PESTICIDE"
'Due to acute toxicity to humans, aquatic organisms, and avian species."
Tor retail sale to and use only by certified applicators or persons under their direct supervision, and only for those
ises covered by the certified applicator's certification."
DPE Established by the RED for
iquid formulations.
'Personal Protective Equipment (PPE)"
'Some materials that are chemical-resistant to this product are (registrant inserts correct chemical-resistant material).
Tf you want more options, follow the instructions for category" [registrant inserts A,B,C,D,E,F,G,or H] "on an EPA
;hemical-resistance category selection chart."
'All handlers except those using engineering controls must wear:
Respirator with
- an organic-vapor removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval
number prefix TC-23C), or
- a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or
- a NIOSH approved respirator with an (OV) cartridge or a canister with any N,R,P or HE filter.
IN ADDITION:
Vlixers and loaders supporting aerial applications who are not using engineering controls
see engineering requirements below), handlers supporting or using high pressure handwand equipment and flaggers
must wear:
• Coveralls over long-sleeved shirt and long pants
• Chemical resistant footwear plus socks
Chemical resistant gloves (except when flagging)
• Chemical resistant head gear when exposed overhead
• Chemical resistant apron when mixing and loading
Ml other mixers, loaders applicators and handlers must wear:
• Long-sleeved shirt and long pants;
• Socks and shoes;
Chemical resistant gloves except, for applicators using enclosed cabs or cockpits,
• Chemical resistant apron when mixing and loading, applying dips cleaning up spills or cleaning/repairing equipment.
A respirator of the type specified above for all handlers except for those using engineering controls."
Precautionary Statements:
mmediately
bllowing/below Hazards to
Humans and Domestic
\nimals
83
-------
Description
Labeling
Placement on Label
DPE Established by the RED for
Wettable Powder Formulation
wettable powder formulations
need to be marketed in water
soluble packaging.)
Personal Protective Equipment (PPE)"
Some materials that are chemical-resistant to this product are" (registrant inserts correct chemical-resistant material).
'If you want more options, follow the instructions for category [registrant inserts A,B,C,D,E,F,G,or H] on an EPA
;hemical-resistance category selection chart."
'All handlers except for those using engineering controls must wear:
Respirator with
- an organic-vapor removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval
number prefix TC-23C), or
- a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or
- a NIOSH approved respirator with an (OV) cartridge or a canister with any N,R,P or HE filter.
In addition:
'Handlers supporting or using high pressure handwand equipment and flaggers must wear:
• Coveralls over long-sleeved shirt and long pants
• Chemical resistant footwear plus socks
• Chemical resistant gloves (except when flagging)
• Chemical resistant head gear when exposed overhead
• Chemical resistant apron when mixing and loading
Ml other mixers, loaders applicators and handlers must wear:
• Long-sleeved shirt and long pants;
• Socks and shoes;
• Chemical resistant gloves except, for applicators using enclosed cabs or cockpits,
Chemical resistant apron when mixing and loading, applying dips cleaning up spills or cleaning/repairing equipment.
A respirator of the type specified above for all handlers except for those using engineering controls.
Precautionary Statements:
mmediately
bllowing/below Hazards to
Humans and Domestic
\nimals
User Safety Requirements
'Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables exist, use
letergent 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
;oncentrate. Do not reuse them."
precautionary Statements:
mmediately following the
DPE requirements
84
-------
Description
Labeling
Placement on Label
ingineering Controls
for Liquid Formulations
Engineering Controls"
'Mixers and loaders supporting aerial applications at the rate of more than 1.5 Ibs/ai per acre or supporting applications
;o alfalfa, cotton, barley, rye oats and wheat and must use a closed system that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(4)] for dermal and inhalation
protection, and must:
~ wear long-sleeved shirt, long pants, shoes, socks, chemical resistant gloves and chemical apron,
~ wear long-sleeved shirt, long pants, shoes, socks,, and
~ be provided and have immediately available for use in an emergency, such as a broken package, spill, or
equipment breakdown coveralls, chemical resistant footwear and the type of respirator specified in the PPE."
'Applicators using airblast equipment on all crops except ornamental trees and shrubs must use an enclosed cab that
meets the definition in the Worker Protection Standard for Agricultural Pesticides [40 CFR 170.240(d)(5)] for dermal
protection. In addition, such applicators must:
~ wear the personal protective equipment required in the PPE section of this labeling ,
~ either wear the type of respirator specified in the PPE section of this labeling or use an enclosed cab that is
declared in writing by the manufacturer or by a government agency to provide at least as much respiratory
protection as the type of respirator specified in the PPE section of this labeling,
~ be provided and must have immediately available for use in an emergency when they must exit the cab in
the treated area: coveralls, chemical-resistant footwear, chemical-resistant headgear, if overhead exposure,
and, if using an enclosed cab that provides respiratory protection, a respirator of the type specified in the PPE
section of this labeling,
~ take off any PPE that was worn in the treated area before reentering the cab, and
~ store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent contamination of the
inside of the cab."
'Pilots must use an enclosed cockpit in a manner that meets the requirements listed in the Worker Protection Standard
WPS) for agricultural pesticides [40 CFR 170.240(d)(6)];"
'When handlers use closed systems and enclosed cabs, in a manner that meets the requirements listed in the Worker
Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the handler PPE requirements may be
reduced or modified as specified in the WPS."
precautionary Statements:
mmediately following the
Jser Safety Requirements
85
-------
Description
Labeling
Placement on Label
ingineering Controls
'or Wettable Powder
"ormulations
Engineering Controls"
'Water-soluble packets when used correctly qualify as a closed mixing/loading system under the Worker Protection
standard for Agricultural Pesticides [40 CFR 170.240(d)(4)]. Mixers and loaders using water-soluble packets must:
- wear long-sleeved shirt, long pants, shoes, socks, chemical resistant gloves and chemical apron,, and
- be provided and must have immediately available for use in an emergency, such as a broken package, spill, or
equipment breakdown coveralls, and the type of respirator specified in the PPE."
'Applicators using airblast equipment on all crops except ornamental trees and shrubs must use an enclosed cab that
meets the definition in the Worker Protection Standard for Agricultural Pesticides [40 CFR 170.240(d)(5)] for dermal
protection. In addition, such applicators must:
~ wear long-sleeved shirt, long pants, shoes, socks,
~ either wear the type of respirator specified in the PPE section of this labeling or use an enclosed cab that is
declared in writing by the manufacturer or by a government agency to provide at least as much respiratory
protection as the type of respirator specified in the PPE section of this labeling,
~ be provided and must have immediately available for use in an emergency when they must exit the cab in
the treated area: coveralls, chemical-resistant footwear, chemical-resistant headgear, if overhead exposure,
and, if using an enclosed cab that provides respiratory protection, a respirator of the type specified in the PPE
section of this labeling,
~ take off any PPE that was worn in the treated area before reentering the cab, and
~ store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent contamination of the
inside of the cab."
'Pilots must use an enclosed cockpit in a manner that meets the requirements listed in the Worker Protection Standard
WPS) for agricultural pesticides [40 CFR 170.240(d)(6)];"
'When handlers use enclosed cabs, in a manner that meets the requirements listed in the Worker Protection Standard
WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the handler PPE requirements may be reduced or modified
is specified in the WPS."
Jser Safety Recommendations
'User Safety Recommendations"
'Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet."
'Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean
;lothing."
'Users should remove PPE immediately after handling this product. Wash the outside of gloves before removing. As
;oon as possible, wash thoroughly and change into clean clothing."
precautionary Statements:
mmediately following
Engineering Controls)
Vfust be placed in a box
86
-------
Description
Labeling
Placement on Label
invironmental Hazards
'Environmental Hazards"
"This product is extremely toxic to fish and aquatic invertebrates and toxic to birds and mammals. Do not apply
lirectly to water, or to areas where surface water is present, or to intertidal areas below the mean high water mark.
Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas. See Spray drift
management instructions under "Directions for use. Do not contaminate water when disposing of equipment wash
waters or rinsate."
precautionary Statements:
mmediately following the
Jser Safety
Recommendations
'Do not enter or allow worker entry into treated areas during the restricted entry interval (REI)."
Restricted Entry Interval (REI).
Directions for Use in the
Agricultural Use
Requirements Box.
Ml crops except for the crops listed below have an REI of 48 hours.
rhe following crop has an REI of 3 days: sweet potato.
rhe following crops grown for seed have an REI of 3 days: collard greens, kale, mustard greens, radish, rutabaga, and
Restricted Entry Intervals (REI)
'or EC Formulations.
urnrp.
rhe following crops NOT grown for seed have an REI of 4 days: kohlrabi, broccoli and cabbage.
rhe following crops also have an REI of 4 days: brussels sprouts and cauliflower.
rhe following crops have an REI of 6 days: blueberries.
rhe following crops grown for seed have an REI of 7 days: kohlrabi, broccoli and cabbage
rhe following crops have an REI of 17 days: sweet/fresh corn
Directions for Use next to
he application instructions
"or each crop
87
-------
Description
•estricted Entry Intervals (REI)
for wettable powder
brmulations.
3arly Entry PPE
Double Notification
Application Restrictions
Labeling
Ml crops except for the crops listed below have an REI of 48 hours.
The following crops have an REI of 3 days: cucumbers, melons, pumpkins, and squash.
The following crops have an REI of 4 days: celery, lettuce, apple, apricot, cherry, nectarines, peach, pear, plum, and
)rune, Christmas trees, ornamental trees and shrubs, and non-bearing citrus trees.
fhe following crops NOT grown for seed have an REI of 4 days: collard greens, kale, mustard greens, radish.
utabaga, and turnip.
fhe following crops grown for seed have an REI of 5 days: collard greens, kale, mustard greens, radish, rutabaga, and
urnip.
fhe following crops have an REI of 9 days: brussels sprouts, cauliflower
fhe following crops NOT grown for seed have an REI of 9 days: kohlrabi, broccoli, cabbage.
fhe following crops for seed have an REI of 12 days: kohlrabi, broccoli, cabbage.
'PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and that involves
;ontact with anything that has been treated, such as plants, soil, or water, is:
* coveralls,
* chemical-resistant gloves made of any waterproof material,
* shoes plus socks,
* protective eyewear"
'Notify workers of the application by warning them orally and by posting warning signs at entrances to treated area."
'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."
Placement on Label
Directions for Use next to
he application instructions
for each crop
Directions for Use in the
Agricultural Use
Requirements Box.
Directions for Use in the
Agricultural Use
Requirements Box.
3lace in the Directions for
Use
-------
Description
Dther Risk Mitigation
Labeling
Reduced Application Rates (maximum a.i. per acre or per gallon per application)
free bark application: 0.005 Ib/ai gallon
Cotton (aerial applications), alfalfa grown for seed, and kale: 0.75 Ib ai/acre
Broccoli, kohlrabi, cabbase and cauliflower not grown not for seed: 1.0 Ib ai/acre
strawberries: 1.0 Ib ai/acre
Cotton (ground applications) and blueberries: 1.5 Ib ai/acre
Vlacadamia nuts: 2.0 Ibs ai/acre
Dome fruit, stone fruit, nonbearins citrus, pecans and ornamental trees and shrubs: 2.5 ai/acre
Reduce Seasonal Application Rate (maximum amount a.i./acre that can be applied in a single season)
Celery: Reduce to 1.0 Ibs ai/acre per season
sweet/fresh corn, cotton (aerial application) and blueberries: Reduce to 1.5 Ibs ai/acre per season
Vlelons, cucumbers, squash, pumpkins, lettuce, tomatoes, sweet potato, cotton (ground applications), broccoli.
;auliflower, cabbase, kohlrabi, brussels sprouts, strawberries, filberts, walnuts, almonds, macadamia nuts, peppers, ess
)lant, potatoes, carrots, dried beans, dried peas and tobacco: Reduce to 2.0 Ibs ai/acre per season.
Dome fruit, stone fruit, nonbearins citrus and pecans: Reduce to 2.5 Ibs ai/acre per season.
Reduce Number of Applications/Season (max. # of applications that can be made in one season)
Mmonds, filberts, macadamia nuts, walnuts, sweet corn, barley, oats, wheat, and rye: Reduce to 1 application per
season.
Broccoli, brussels sprouts, cauliflower, cabbase, cotton, dry deans, dry peas, kohlrabi, lettuce, strawberry, sweet
potatoes, tobacco: Reduce to 2 applications per season.
Vlelons, cucumber, squash and pumpkins: Reduce to 4 applications per season except for CA where the maximum
lumber of applications per season is 3.
Dotatoes, tomatoes: Reduce to 4 applications per season.
Placement on Label
Directions for Use under
ipplication instructions
md/or restrictions
89
-------
Description
Labeling
Placement on Label
Dther Risk Mitigation
continued)
Site/Crop Deletions (remove the following sites or crops from the label)
Ml formulations:
arapes (all types)
spinach
succulent Beans
succulent Peas
'ecans
Wettable Powders:
Mfalfa (grown for seed only) Pineapple
Blueberries Strawberries
Carrots Small Grains (barley, oats, rye, and wheat)
'otton Sweet Corn
Dry Beans Sweet Potatoes
Dry Peas Tobacco
Tomato
Application Equipment/Method Deletions:
Revise applications instructions for the below crops to remove and prohibit aerial applications:
Directions for Use under
ipplication instructions
md/or restrictions
Wettable powder formulations only:
\pricots
Deaches
Nectarines
Dlum/Prune
Cherries
Non-bearing Citrus
Radish (grown for seed only)
Turnip (grown for seed only)
Rutabaga (grown for seed only)
Broccoli (grown for seed only)
Cabbage (grown for seed only)
Kohlrabi (grown for seed only)
Almonds
Macadamia Nuts
Filberts
Walnuts
Kale (grown for seed only)
Collard Greens (grown for seed only)
Vlustard Greens (grown for seed only)
"or all formulations, prohibit use of high pressure hand wand on all sites except to bark treatment or tobacco drench.
90
-------
Description
Labeling
Placement on Label
spray Drift Labeling
'Do not allow spray to drift from the application site and contact people, structures people occupy at any time and the
issociated property, parks and recreation areas, non-target crops, aquatic and wetland areas, woodlands, pastures,
•angelands, or animals."
'A 30 ft. vegetative buffer strip must be maintained between all areas treated with this product and rivers, natural
)onds, lakes, streams, reservoirs, marshes, estuaries and commercial fish ponds."
'For ground boom applications, do not apply within 100 feet of rivers, natural ponds, lakes, streams, reservoirs,
marshes, estuaries and commercial fish ponds. Apply with nozzle height no more than 4 feet above the ground or crop
;anopy and when wind speed is 10 mph or less at the application site as measured by an anemometer. Use (registrant
;o fill in blank with spray quality, e.g. fine or medium) or coarser spray according to ASAE 572 definition for standard
nozzles or VMD for spinning atomizer nozzles."
'For orchard/vineyard airblast applications, do not apply within 100 feet of rivers, natural ponds, lakes, streams,
•eservoirs, marshes, estuaries and commercial fish ponds. Direct spray above trees/vines and turn off outward pointing
nozzles at row ends and outer rows. Apply only when wind speed is 3 -10 mph at the application site as measured by
m anemometer outside of the orchard/vineyard on the upwind side."
'For aerial applications, do not apply within 300 feet of rivers, natural ponds, lakes, streams, reservoirs, marshes,
estuaries and commercial fish ponds. The boom width must not exceed 75% of the wingspan or 90% of the rotary
)lade. Use upwind swath displacement and apply only when wind speed is 3 - 10 mph as measured by an
memometer. Use (registrant to fill in blank with spray quality, e.g. fine or medium) or coarser spray according
;o ASAE 572 definition for standard nozzles or VMD for spinning atomizer nozzles. If application includes a no-
;pray zone, do not release spray at a height greater than 10 feet above the ground or the crop canopy."
For overhead chemigation, do not apply within 100 feet of rivers, natural ponds, lakes, streams, reservoirs, marshes,
:stuaries and commercial fish ponds. Apply only when wind speed is 10 mph or less."
The applicator also must use all other measures necessary to control drift."
Directions for Use under
General application
nstructions and/or
•estrictions
91
-------
VI. APPENDICES
92
-------
Appendix A. Endosulfan Table of Use Patterns Reflecting Label Changes Based on Mitigation Measures
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Alfalfa (grown for seed)
Foliar treatment
Ground or aerial
3 Ib/gal EC
[CA860035]
3 Ib/gal EC
rvT\ TO£r\r\r\£~\
[NV860005J
3 Ib/gal EC
[WA880012]
l.Olb/A
l.Olb/A
0 5 Ib/A
2
2
2
l.Olb/A
(NS)
NS
21
(NS)
21
Require closed mixing/loading systems for aerial
application. Reduce application rate to Ib./ai/A. WP
formulation canceled. Use limited to CA. Applications
may be made in a minimum of 10 gal/A by ground or 5
gal/A by air. The feeding or grazing of treated foliage,
crop residues, or seed millings and the use of treated seed
for livestock food or feed are prohibited.
Use limited to NV. Applications may be made in a
minimum of 10 gal/A by ground or 2 gal/A by air. The
feeding or grazing of treated foliage, crop residues, or
seed millings and the use of treated seed for livestock
food or feed are prohibited.
Use limited to WA. Applications may be made in a
minimum of 25 gal/A by ground or 10 gal/A by air. The
feeding or grazing of treated foliage, crop residues, or
seed screening is prohibited.
Almond
Delayed dormant or foliar
(during popcorn, pink, or
petal fall)
Ground or aerial
2 Ib/gal EC
[279-2659]
2.0 Ib/A
1
2.0 Ib/A
NS
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial application using the
WP formulation. Require closed mixing/loading systems
for aerial application using the EC formulation. Require
closed cabs for airblast applications. Reduce application
rate from 31bs./ai/A to 21bs./ai/A. Reduce maximum
number of applications per season from 2 to 1 .
Application may be made in a minimum of 200 gal of
water/A (dilute) or 40 gal of water/A (concentrate). The
grazing of livestock on orchard crops or grasses in treated
areas is prohibited*. Treated hulls may be fed to
livestock and dairy animals.
93
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Apple
Delayed dormant and/or
foliar (during pink and/or
petal fall)
Ground or aerial
Foliar treatment
Ground or aerial
50% WP
[279-1380]
[279-3129]
[45639-194]
[66222-2]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[45639-198]
3 Ib/gal EC
[45639-197]
3 Ib/gal EC
[WA880012]
0.51b/100galor
2.5 Ib/A
0.51b/100galor
2.5 Ib/A
0.51b/100galor
2.5 Ib/A
0.5 Ib/A
3
(2 per fruiting
period)
3
(2 per fruiting
period)
2
2
2.5 Ib/A
2.5 Ib/A
2.5 Ib/A
2.5 Ib/A
21
30
30
21
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation. Require
closed cabs for airblast applications. A second
application may be made 10 days later. The feeding of
pomace from treated apples to livestock, the feeding of
cull fruits to animals, or allowing livestock to graze in
treated orchards is prohibited.*
Use limited to CA. Reduce maximum application rate to
2.51bs./ai/A. Require all wettable powder formulations to
be packaged in water soluble bags. Cancel aerial
applications using WP formulation. For EC formulation
require closed mixing/loading systems for aerial
applications. Require closed cabs for airblast
applications. The feeding of pomace from treated apples
to livestock, the feeding of cull fruits to animals, or
allowing livestock to graze in treated orchards is
prohibited.*
Use limited to WA. Reduce maximum application rate to
2.51bs./ai/A.
For EC formulation require closed mixing/loading
systems for aerial applications. Require closed cabs for
airblast applications. Applications may be made in a
minimum of 25 gal/A by ground or 10 gal/A by air. The
feeding or grazing of treated foliage, crop residues, or
seed screening is prohibited.
94
-------
Site
Application Type
Application Timing
Application Equipment
Foliar treatment
Aerial
Formulation
[EPA Reg. No.]
50% WP
[WA780033]
Maximum Single
Application Rate
(ai)
1.51b/A
Maximum
Number of
Applications Per
Season
NS
Maximum
Seasonal Rate
(ai)
2.5 Ib/A
Preharvest
Interval
(Days)
NS
Use Directions and Limitations
Use limited to WA. Reduce maximum application rate to
2.51bs./ai/A. Require all wettable powder formulations to
be packaged in water soluble bags. Cancel aerial
applications using WP Applications may be made in a
minimum of 3 gal of water/A using aerial equipment.
Apricot
Bark treatment
Postharvest
Ground
Foliar treatment
Ground or aerial
50% WP
[279-1380]
[279-3129]
[45639-194]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[66222-2]
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
0.75 lb/100 gal
(Pacific Northwest)
2.5 lb/100 gal
(Southeastern states)
0.75 lb/100 gal
(West coast)
2.5 lb/100 gal
(Southeastern states)
0.5 lb/100 gal
2C TU / A
.5 Ib/A
2
2
2
2 5 Ib/A
2.5 Ib/A
2.5 Ib/A
21
21
30
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation. Require
closed cabs for airblast applications.
The feeding of cull fruits to animals or allowing
livestock to graze in treated orchards is prohibited.*
Reduce maximum application rate to 2.51bs./ai/A.
Require closed mixing/loading systems for aerial
applications using the EC formulation. Require closed
cabs for airblast applications. The feeding of cull fruits
to animals or allowing livestock to graze in treated
orchards is prohibited. * Use of the 50% WP (EPA Reg.
No. 45639-198) and the 3 Ib/gal EC (EPA Reg. No.
45639-197) formulations is limited to CA.
95
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Barley
Foliar treatment
Ground or aerial
50% WP
[279-1380]
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[279-1380]
[279-3129]
[66222-22]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
0 5 Ib/A
0.75 Ib/A
2
2
1 0 Ib/A
l.Olb/A
NS
NS
Require all wettable powder formulations to be packaged
in water soluble bags. Applications may be made in a
minimum of 10 gal of water/A using ground equipment.
For control of army cutworm, aerial applications may be
made in a minimum of 2 gal of crop oil, diesel oil, or
water/A. Use limited to IL, IN, MI, and OH for control
of cereal leaf beetle, aerial applications may be made in a
minimum of 1 gal of water/A. The feeding of treated
forage to livestock and application after heads begin to
form are prohibited. *
Require all wettable powder formulations to be packaged
in water soluble bags.
Require closed mixing/loading systems for aerial
applications of the EC formulation. Require closed cabs
for airblast applications. Applications may be made in a
minimum of 10 gal/A by ground or 1 gal/A by air. The
feeding of treated forage to livestock and application
after heads begin to form are prohibited.* Use of the 3
Ib/gal EC (EPA Reg. No. 45639-197) formulation is
limited to CA.
Bean, succulent
Foliar treatment
Ground or aerial
50% WP
[279-1380]
[279-3129]
[45639-194]
[45639-198]
[66222-22]
Succulent Green
Beans Canceled
Succulent Green
Beans Canceled
Succulent
Green Beans
Canceled
Succulent
Green Beans
Canceled
Endosulfan use on succulent green beans canceled.
96
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Bean, dry
Foliar treatment
Ground or aerial
2 Ib/gal EC
[279-2659]
[279-2735]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
3 Ib/gal EC
[279-3222]
Dry Beans
Ibs./ai/A
l.Olb/A
Dry Beans
2
3
Dry Beans
2.0 Ib/A
3.0 Ib/A
Dry Beans
21
For dry beans, cancel WP use. Reduce maximum seasonal
application rate from 31bs./ai/A to 2 Ibs.ai/A. Reduce
maximum number of applications per season from 3 to 2.
Endosulfan use on succulent green beans canceled
Blueberry
Postharvest treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
1.51b/A
2
1.51b/A
NS
Reduce maximum seasonal application rate from
31bs./ai/A to 1.5 Ibs./ai/A. Require all wettable powder
formulations to be packaged in water soluble bags.
Require closed mixing/loading systems for aerial
applications using the EC formulation. Cancel aerial
application using the WP formulation. Applications may
be made after harvest in 3 lbs./ai/300 gal of water with a
6- to 8- week pretreatment interval. Application after
buds are well formed is prohibited. *
97
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Broccoli
Foliar treatment
Ground or aerial
Foliar treatment
Ground or aerial
50% WP
[45639-194]
[66222-22]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[279-3129]
50% WP
[45639-198]
3 Ib/gal EC
[45639-197]
1 0 Ib/A
l.Olb/A
1.0 Ib/A
3
2
2 0 Ib/A
2.0 Ib/A
2.0 Ib/A
7
7
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum seasonal application rate
from 31bs./ai/A to 2.0 Ibs./ai/A. Reduce maximum
number of applications from 4 per season to 2 per season.
Applications may be made in a minimum of 10 gal/A by
ground or 1-3 gal/A by air.
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum seasonal application rate
from 31bs./ai/A to 2.0 Ibs./ai/A. Reduce maximum
number of applications from 4 per season to 2 per season.
For use on broccoli, including Chinese broccoli.
Applications may be made in a minimum of 10 gal/A by
ground or 1 gal/A by air.
Use limited to CA. Require all wettable powders to be
packaged in water soluble bags. Number of applications
per season remains at 2. Applications may be made in a
minimum of 10 gal/A by ground or 1 gal/A by air.
98
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Brussels sprouts
Foliar treatment
Ground or aerial
Foliar treatment
Ground or aerial
50% WP
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2735]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[279-3129]
50% WP
[45639-198]
3 Ib/gal EC
[45639-197]
l.Olb/A
l.Olb/A
l.Olb/A
2
2
2
2.0 Ib/A
2.0 Ib/A
2.0 Ib/A
14
14
14
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum application rate from
31bs./ai/A to 2.0 Ibs./ai/A. Reduce maximum number of
applications from 4 per season to 2 per season.
Applications may be made in a minimum of 10-25 gal/A
by ground or 1-3 gal/A by air.
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum application rate from
31bs./ai/A to 2.0 Ibs./ai/A. Reduce maximum number of
applications per season from 4 per season to 2 per season.
Applications may be made in a minimum of 10 gal/A by
ground or 1 gal/A by air.
Use limited to CA. Require all wettable powders to be
packaged in water soluble bags. Number of applications
per season remains at 2. Applications may be made in a
minimum of 10 gal/A by ground or 1 gal/A by air.
99
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Cabbage
Foliar treatment
Ground or aerial
50% WP
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2735]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[279-3129]
50% WP
[45639-198]
3 Ib/gal EC
[45639-197]
3 Ib/gal EC
[279-3222]
l.Olb/A
l.Olb/A
1 0 Ib/A
0.75 Ib/A
4
3
2
3
2.0 Ib/A
2.0 Ib/A
2 0 Ib/A
2.0
7
7
7
14
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum application rate from
31bs./ai/A to 2.0 Ibs./ai/A. Reduce maximum number of
applications from 4 per season to 2 per season.
Applications may be made in a minimum of 10-25 gal/A
by ground or 1-3 gal/A by air.
For use on cabbage, including Chinese cabbage or Napa.
Applications may be made in a minimum of 10 gal/A by
ground or 1 gal/A by air.
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum seasonal application rate
from 31bs./ai/A to 2.0 Ibs./ai/A. Reduce maximum
number of applications from 4 per season to 2 per season.
Applications may be made in a minimum of 10-25 gal/A
by ground or 1-3 gal/A by air.
Applications may be made in a minimum of 10 gal/A by
ground or 1 gal/A by air.
100
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Cabbage (grown for seed)
Foliar treatment
Ground or aerial
3 Ib/gal EC
[WA760012]
50% WP
[WA780029]
1 IH/rrnl TnP
.J lU/gdl .C,^
[OR770043]
[WA770016]
2.0 Ib/A
2.0 Ib/A
2
2
NS
NS
NS
NS
Require all wettable powder formulations to be packaged
in water soluble bags. Require closed mixing/loading
systems for aerial applications using the EC formulation.
Cancel aerial application using the WP formulation. Use
limited to WA. Applications may be made in a minimum
of 20 gal/A by ground or 5 gal/A by air. The grazing of
livestock in treated areas and the use of treated crop or
crop residue or screening for food or feed are
prohibited.*
Require all wettable powder formulations to be packaged
in water soluble bags. Require closed mixing/loading
systems for aerial applications using the EC formulation.
Cancel aerial application using the WP formulation. Use
limited to OR and WA on cabbage including Chinese
cabbage. Applications may be made in a minimum of 20
gal/A by ground or 5 gal/A by air. Use of treated crops
or crop residue or sweepings for food or feed and the
grazing of livestock on treated areas are prohibited.*
Carrot
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2735]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-1971
l.Olb/A
1
2.0 Ib/A
7
Cancel WP use. Reduce maximum seasonal application
rate from 31bs./ai/A to 2 Ibs./ai/A. Applications may be
made in a minimum of 10-25 gal/A by ground or 1 gal/A
by air. Use of tops for food or feed is prohibited.* Use
of the 50% WP (EPA Reg. No. 45639-198) and the 3
Ib/gal EC (EPA Reg. No. 45639-197) formulations is
limited to CA.
101
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Carrot, continued
Foliar treatment
Ground or aerial
3 Ib/gal EC
[279-2149]
l.Olb/A
1
2.0 Ib/A
15
Applications may be made in a minimum of 10 gal/A by
ground or 1 gal/A by air. Use of tops for food or feed is
prohibited.
Cauliflower
Foliar treatment
Ground or aerial
50% WP
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2735]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[279-3129]
3 Ib/gal EC
[279-2149]
50% WP
[45639-198]
3 Ib/gal EC
[45639-197]
l.Olb/A
l.Olb/A
0.75 Ib/A
l.Olb/A
4
3
2
2
2.0 Ib/A
2.0 Ib/A
2.0 Ib/A
2.0 Ib/A
14
14
14
14
See "Brussels sprouts".
See "Brussels sprouts".
See "Brussels sprouts".
See "Brussels sprouts".
102
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Celery
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
l.Olb/A
l.Olb/A
1
2
l.Olb/A
l.Olb/A
4
7
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum seasonal application rate
from 31bs./ai/A to llbs./ai/A. Application may be made in
a minimum of 10 gal/A by ground or 1 gal/A by air. Use
of the 50% WP (EPA Reg. No. 45639-198) and the 3
Ib/gal EC (EPA Reg. No. 45639-197) formulations is
limited to CA.
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum seasonal application rate
from 31bs./ai/A to llbs./ai/A. Application may be made in
a minimum of 10 gal/A by ground or 1 gal/A by air. Use
of the 50% WP (EPA Reg. No. 45639-198) and the 3
Ib/gal EC (EPA Reg. No. 45639-197) formulations is
limited to CA.
Cherry
Bark treatment
Ground
Bark treatment
Postharvest
Ground
50% WP
[279-3129]
3 Ib/gal EC
[279-2924]
50% WP
[45639-194]
[66222-22]
0 75 lb/100 gal
0.75 lb/100 gal
2
2
.0005
Ibs./ai/gal
2.5 Ib/A
21
21
Reduce maximum application rate to 0.005 Ibs./ai/gal for
high pressure handwands and rights-of-way sprayer. The
feeding of cull fruits to animals or allowing livestock to
graze in treated orchards is prohibited.*
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum seasonal application rate
from 31bs./ai/A to 21bs./ai/A. Cancel aerial application
using WP formulation..
103
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Cherry, continued
Bark treatment
Postharvest
Ground
Delayed dormant (popcorn
or prepink stage)
Ground or aerial
Delayed dormant
Ground or aerial
Foliar treatment
Ground or aerial
3 Ib/gal EC
[45639-169]
50% WP
[279-3129]
r/i z^i n in/ii
[45639-194]
[45639-198]
[66222-22]
3 Ib/gal EC
ri'vo i no /i i
[z /9-z9z4J
[45639-169]
[45639-197]
50% WP
[279-3129]
[45639-194]
[66222-22]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-221
0.75 lb/100 gal
0.5 lb/100 gal
2.5 Ib/A
1.0 lb/100 gal
0.5 lb/100 gal
2
2
2
2
2.5 Ib/A
2.5 Ib/A
3.0 Ib/A
3.0 Ib/A
21
21
21
21
Require closed mixing/loading systems for aerial
application suing the EC formulation. Require closed
cabs for airblast applications. The feeding of cull fruits to
animals or allowing livestock to graze in treated orchards
is prohibited. *
Use limited to Pacific Northwest. Require all wettable
powders to be packaged in water soluble bags. Reduce
maximum seasonal application rate from 31bs./ai/A to
21bs./ai/A. Cancel aerial application using WP
formulation. The feeding of cull fruits to animals or
allowing livestock to graze in treated orchards is
prohibited.* Use of the 50% WP (EPA Reg. No. 45639-
198) and the 3 Ib/gal EC (EPA Reg. No. 45639-197)
formulations is limited to CA.
Use limited to MI. Require all wettable powders to be
packaged in water soluble bags. Reduce maximum
seasonal application rate from 31bs./ai/A to 21bs./ai/A.
Cancel aerial application using WP formulation.
Require closed mixing/loading systems for aerial
application suing the EC formulation. Require closed
cabs for airblast applications. The feeding of cull fruits to
animals or allowing livestock to graze in treated orchards
is prohibited. *
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum seasonal application rate
from 31bs./ai/A to 21bs./ai/A. Cancel aerial application
using WP formulation..
104
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Cherry (continued)
Foliar treatment
Ground or aerial
Nursery stock dip
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
2.5 Ib/A
2 lb/40 gal
2
NS
3.0 Ib/A
NS
21
Not
applicable
(NA)
Require closed mixing/loading systems for aerial
application suing the EC formulation. Require closed
cabs for airblast applications The feeding of cull fruits to
animals or allowing livestock to graze in treated orchards
is prohibited. * Use of the 50% WP (EPA Reg. No.
45639-198) and the 3 Ib/gal EC (EPA Reg. No. 45639-
197) formulations is limited to CA.
Immerse trees so that the roots and crowns are covered
well above the grafting bud scar; plant immediately or
dry before returning to storage. Use of the 50% WP
(EPA Reg. No. 45639-198) and the 3 Ib/gal EC (EPA
Reg. No. 45639-197) formulations is limited to CA.
Citrus (nonbearing trees and nursery stock)
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
0.25 lb/100
2C 11_ / A
.5 Ib/A
2
2 5 Ib/A
NS
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum seasonal application rate
from 31bs./ai/A to 21bs./ai/A. Cancel aerial application
using WP formulation. Require closed mixing/loading
systems for aerial application suing the EC formulation.
Application to bearing trees or trees that will bear fruit
within 12 months is prohibited. Use of the 50% WP
(EPA Reg. No. 45639-198) formulation is limited to CA.
105
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Citrus (nonbearing trees and nursery stock), continued
Foliar treatment
Ground or aerial
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
0.5 lb/100
2.5 Ib/A
2
2.5 Ib/A
NS
Application to bearing trees or trees that will bear fruit
within 12 months is prohibited. Use of the 3 Ib/gal EC
(EPA Reg. No. 45639-197) formulation is limited to CA.
Collards
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2735]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[45639-198]
3 Ib/gal EC
[45639-197]
l.Olb/A
0.75 Ib/A
1
1
l.Olb/A
0.75 Ib/A
21
21
Require all wettable powders to be packaged in water
soluble bags. Application may be made in a minimum of
10-25 gal/A by ground or 1 gal/A by air.
Use limited to CA. Require all wettable powders to be
packaged in water soluble bags. Application may be
made in a minimum of 10 gal/A by ground or 1 gal/A by
air.
Collards (grown for seed)
Foliar treatment
Ground or aerial
50% WP
[WA780029]
3 Ib/gal EC
[OR770043]
[WA770016]
2.0 Ib/A
2
NS
NS
Require all wettable powders to be packaged in water
soluble bags. Require closed mixing/loading systems for
aerial applications using the EC formulation. Cancel
aerial application using the WP formulation.
106
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Corn, sweet
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
3 Ib/gal EC
[279-2924]
p/ic/r^ri l/;m
[43639-169J
[45639-197]
1.51b/A
1
1.51b/A
1
Cancel WP use. Reduce maximum seasonal application
rate from 31bs./ai/A to 1.51bs./ai/A. Require closed
mixing/loading systems for aerial application using the
EC formulation. Use limited to fresh vegetable;
application to sweet corn to be processed is prohibited.*
Applications may be made in a minimum of 10 gal/A by
ground or 1-5 gal/A by air with a 5-day pretreatment
interval. The feeding of treated forage or ensilage to
livestock or the grazing of livestock in treated fields is
prohibited.* Use of the 3 Ib/gal EC (EPA Reg. No.
45639-197) is limited to CA.
Cotton
Foliar treatment (until bolls
open)
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
3 Ib/gal EC
[279-2149]
[279-3222
1 5 Ib/A
1.51b/A
2
2
1.5 Ib/A
(aerial)
2r\ iVi / A
.0 Ib/A
(ground)
1.5.01b/A
(aerial)
2.0 Ib/A
(ground)
NS
NS
Cancel WP use. Reduce rate for ground application to 1.5
Ibs./ai/A. Reduce rate for aerial application to 0.75
Ibs./ai/A Require closed mixing/loading systems for
aerial application suing EC formulation. Reduce
maximum seasonal application rate from 31bs./ai/A to
21bs./ai/A (ground) and reduce maximum seasonal
application rate from 31bs./ai/A to 1.5 Ibs./ai/A (aerial).
Reduce maximum number of applications per season
from 6 to 2. Restrict use on cotton to the following states:
AZ, CA, NM, OK, and TX. Applications may be made
in a minimum of 10 gal/A by ground or 1 gal/A by air.
The grazing of dairy or meat animals in treated fields and
application after bolls open are prohibited.* Use of the 3
Ib/gal EC (EPA Reg. No. 45639-197) is limited to CA.
Applications may be made in a minimum of 10 gal/A by
ground or 1 gal/A by air. The grazing of dairy or meat
animals in treated fields and application after bolls open
are prohibited. *
107
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Cotton (continued)
Foliar treatment (after bolls
open)
Ground or aerial
2 Ib/gal EC
[AZ930014]
[AZ930016]
0.75 Ib/A
NS
1.5.01b/A
(aerial)
2.0 Ib/A
(ground)
14
Use limited to AZ. Applications may be made in a
minimum of 10 gal/A using ground or aerial equipment.
Cucumber
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[45639-198]
3 Ib/gal EC
[45639-197]
l.Olb/A
1 0 Ib/A
4
3
2.0 Ib/A
2 0 Ib/A
2
2
Require all wettable powders be packaged in water
soluble bags. Reduce maximum number of applications
per season from 6 to 4. Reduce maximum seasonal
application rate from 31bs./ai/A to 2 Ibs./ai/A.
Applications may be made in a minimum of 10 gal/A by
ground or 1 gal/A by air.
Use limited to CA. Require all wettable powders be
packaged in water soluble bags. Reduce maximum
seasonal application rate from 31bs./ai/A to 2 Ibs./ai/A.
Maintain maximum number of applications per season at
3. Applications may be made in a minimum of 10 gal/A
bv ground or 1 gal/A bv air.
108
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Eggplant
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
3 Ib/gal EC
[279-2924]
[45639-169]
1 0 Ib/A
2
2 0 Ib/A
\
Require all wettable powders be packaged in water
soluble bags. Reduce maximum seasonal application rate
from 31bs./ai/A to 21bs./ai/A. Applications may be made
in a minimum of 10 gal/A by ground or 1 gal/A by air.
Eggplant, continued
Foliar treatment
Ground or aerial
3 Ib/gal EC
[45639-197]
50% WP
[45639-198]
0 5 Ib/A
0.5 Ib/A
2
I
2 0 Ib/A
2.0 Ib/A
\
I
Use limited to CA. Require all wettable powders be
packaged in water soluble bags. Applications may be
made in a minimum of 10 gal/A by ground or 1 gal/A by
air.
Use limited to CA. Require all wettable powders be
packaged in water soluble bags Applications may be
made in a minimum of 10 gal/A by ground or 1 gal/A by
air.
Filbert
Foliar treatment
Ground or aerial
50% WP
[279-1380]
[279-3129]
[45639-194]
[45639-198]
[66222-22]
50% WP
[OR780020]
0.5 lb/100 gal
2.0 Ib/A
0.5 lb/100 gal
(300 gal/A; dilute)
1.51b/A
(25 gal/A;
concentrate)
I
NS
2.0 Ib/A
NS
1
NS
Require all wettable powders to be packaged in water
soluble bags. Cancel aerial application using the WP
formulation. Require closed mixing/loading systems for
aerial application using the EC formulation. Require
closed cabs for airblast application. Reduce maximum
seasonal application rate from 2 per season to 1 . Reduce
maximum seasonal application rate from 31bs./ai/A to 2
Ibs./ai/A. The grazing of livestock on orchard crops or
grasses in treated areas is prohibited. * Use of the 50%
WP (EPA Reg. No. 45639-198) formulation is limited to
CA.
Use limited to OR. Application may be made in a
minimum of 300 gal of water/A (dilute) or in 25 gal of
water/A (concentrate). The grazing of livestock in
treated groves is prohibited. * No PHI has been
established.
109
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Grape
Foliar treatment
Ground (preferred)
Foliar treatment
Ground
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
3 Ib/gal EC
[CA760115]
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not
Applicable
Not
Applicable
Not
Applicable
Not
Applicable
Endosulfan use on grapes canceled
Endosulfan use on grapes canceled
Kale
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
0.75 Ib/A
1
0.75 Ib/A
21
Reduce maximum application rate to 0.75 Ibs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Applications may be made in a
minimum of 10 gal/A by ground or 1 gal/A by air. Use
of the 50% WP (EPA Reg. No. 45639-198) and the 3
Ib/gal EC (EPA Reg. No. 45639-197) formulations is
limited to CA.
110
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Kale (grown for seed)
Foliar treatment
Ground or aerial
50% WP
[WA780029]
3 Ib/gal EC
[OR770043]
[WA770016]
2.0 Ib/A
2
NS
NS
Require all wettable powder formulations to be packaged
in water soluble bags. Require closed mixing/loading
systems for aerial application using EC formulation.
Cancel aerial application using the WP formulation.
Kohlrabi (grown for seed)
Foliar treatment
Ground or aerial
50% WP
[WA780029]
3 Ib/gal EC
[OR770043]
[WA770016]
7 0 Ih/A
Z,.\J lU/.r~i
7
Z.
NS
IN o
NS
IN o
Require all wettable powder formulations to be packaged
in water soluble bags. Require closed mixing/loading
systems for aerial application using EC formulation.
Cancel aerial application using the WP formulation.
Lettuce, head
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-1971
1.0 Ib/A
2
2.0 Ib/A
14
Require all wettable powder formulations to be packaged
in water soluble bags. Reduce maximum seasonal
application rate from 31bs./ai/A to 2 Ibs./ai/A. Reduce
number of applications per season from 3 to 2.
Applications may be made in a minimum of 10 gal/A by
ground or 1 gal/A by air. The feeding of crop refuse to
livestock is prohibited. * Remove wrapper leaves at
harvest.* Use of the 50% WP (EPA Reg. No. 45639-
198) and the 3 Ib/gal EC (EPA Reg. No. 45639-197)
formulations is limited to CA.
Ill
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Lettuce, leaf
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
l.Olb/A
2
2.0 Ib/A
14
Require all wettable powder formulations to be packaged
in water soluble bags. Reduce maximum seasonal
application rate from 31bs./ai/A to 2 Ibs./ai/A. Number of
applications per season will remain at 2 in CA.
Applications may be made in a minimum of 10 gal/A by
ground or 1 gal/A by air. The feeding of crop refuse to
livestock is prohibited. Use of the 50% WP (EPA Reg.
No. 45639-198) and the 3 Ib/gal EC (EPA Reg. No.
45639-197) formulations is limited to CA.
Macadamia nut
Foliar treatment
Ground or aerial
Foliar treatment
Ground
2 Ib/gal EC
[279-2659]
[279-2822]
50% WP
[HI880008]
l.Olb/lOOgal
l.Olb/lOOgal
2
2
2.0 Ib/A
2.0 Ib/A
1
2
Require all wettable powders to be packaged in water
soluble bags. Cancel aerial application using the WP
formulation. Require closed mixing/loading systems for
aerial application using the EC formulation. Require
closed cabs for airblast application. Reduce maximum
seasonal application rate from 2 per season to 1 . Reduce
maximum seasonal application rate from 31bs./ai/A to 2
Ibs./ai/A. The grazing of livestock on orchard crops or
grasses in treated areas is prohibited.
Use limited to HI. The grazing of livestock on orchard
crops or grasses in treated areas. * Application by aircraft
is prohibited.
112
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Melons
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[45639-198]
3 Ib/gal EC
[45639-197]
l.Olb/A
l.Olb/A
4
3
2.0 Ib/A
2.0 Ib/A
2
2
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum seasonal application rate
from 31bs./ai/A to 2 Ibs./ai/A. Reduce maximum number
of applications per season from 6 to 4 (except in CA
where the application per season will remain at 3.
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum seasonal application rate
from 31bs./ai/A to 2 Ibs./ai/A. Reduce maximum number
of applications per season from 6 to 4 (except in CA
where the application per season will remain at 3.
Mustard greens
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-1691
0.75 Ib/A
1
0.75 Ib/A
21
Reduce maximum application rate to 0.75 Ibs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags Application may be made in a
minimum of 10 gal/A by ground or 1 gal/A by air.
113
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
JVlaximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Mustard greens (continued)
Foliar treatment
s-\ -i • 1
Ground or aerial
50% WP
[45639-198]
3 Ib/gal EC
[45639-197]
50% WP
[WA780029]
3 Ib/gal EC
[OR770043]
0.75 Ib/A
0.75 Ib/A
1
1
0.75 Ib/A
0.75 Ib/A
21
NS
Reduce maximum application rate to 0.75 Ibs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Application may be made in a
minimum of 10 gal/A by ground or 1 gal/A by air. Use
of the 50% WP (EPA Reg. No. 45639-198) and the 3
Ib/gal EC (EPA Reg. No. 45639-197) formulations is
limited to CA.
Reduce maximum application rate to 0.75 Ibs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags.
Nectarine
Bark treatment
Postharvest
Ground
50% WP
[279-3129]
[45639-194]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[279-1380]
0.75 lb/100 gal
(Pacific Northwest)
2.5 lb/100 gal
(Southeastern states)
0.75 lb/100 gal
(West coast)
2
2
2.5 Ib/A
2.5 Ib/A
21
21
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation. Require
closed cabs for airblast applications.
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation. Require
closed cabs for airblast applications.
114
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Nectarine (Continued)
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
0.5 lb/100 gal
2.5 Ib/A
2
2.5 Ib/A
30
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation. Require
closed cabs for airblast applications.
Oats
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
0.5 Ib ai/A
1
l.Olb/A
NS
Cancel WP use. Require closed mixing/loading systems
for aerial application using EC formulation. Reduce
maximum number of applications from 2 per season to 1 .
115
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Oats (continued)
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[66222-22]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
0.75 Ib/A
1
l.Olb/A
NS
Cancel WP use. Require closed mixing/loading systems
for aerial application using EC formulation. Reduce
maximum number of applications from 2 per season to 1 .
Peach
Bark treatment
Postharvest
Ground
50% WP
[279-3129]
[45639-194]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[279-1380]
[66222-22]
0.75 lb/100 gal
(Pacific Northwest)
2.5 lb/100 gal
(Southeastern states)
0.75 lb/100 gal
(West coast)
2.5 lb/100 gal
(Southeastern states)
2
2
2.5 Ib/A
2.5 Ib/A
21
21
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation. Require
closed cabs for airblast applications.
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation. Require
closed cabs for airblast applications.
116
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Peach (continued)
Foliar treatment
Ground or aerial
Nursery stock dip
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
50% WP
[27-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
0.5 lb/100 gal
2.5 Ib/A
0.005 lbs./ai/ gal
2
NS
2.5 Ib/A
NS
30
NA
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation. Require
closed cabs for airblast applications.
Reduce maximum application rate to 0.005 Ibs Ibs.ai/A
from 0.4 Ibs/ai/gal for high pressure handwand and
rights-of way sprayers.
117
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Pear
Delayed dormant and foliar
(during white bud or petal
fall)
Ground or aerial
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
2 Ib/gal EC
[279-2822]
0.5 lb/100 gal
2C 11_ / A
.5 Ib/A
2.5 Ib/A
0.75 lb/100 gal
[300 gal of finished
sprav/Al
2
2
2
2 5 Ib/A
2.5 Ib/A
2.5 Ib/A
7
7
7
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation. Require
closed cabs for airblast applications. The feeding of cull
fruits to animals or allowing livestock to graze in treated
orchards is prohibited.*
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation.
Application may be made in a minimum of 10-20 gal of
water/A by air, in 40 gal (semi-concentrate), or in 300 gal
(dilute). The feeding of cull fruits to animals or allowing
livestock to graze in treated orchards is prohibited. * Use
of the 50% WP (EPA Reg. No. 45639-198) and the 3
Ib/gal EC (EPA Reg. No. 45639-197) formulations is
limited to CA.
The feeding of cull fruits to animals or allowing livestock
to graze in treated orchards is prohibited.*
118
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Pear (continued)
Soil treatment
Prebloom
Ground
Postharvest or dormant
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
0.5 lb/100 gal
[200-400 gal of
finished spray /A]
0.5 lb/100 gal
2
2
2.5 Ib/A
2.5 Ib/A
7
7
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation.
Applications may be made to the orchard floor. The
feeding of cull fruits to animals or allowing livestock to
graze in treated orchards is prohibited. * Use of the 50%
WP (EPA Reg. No. 45639-198) and the 3 Ib/gal EC (EPA
Reg. No. 45639-197) formulations is limited to CA.
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation. The
feeding of cull fruits to animals or allowing livestock to
graze in treated orchards is prohibited.* Use of the 50%
WP (EPA Reg. No. 45639-198) and the 3 Ib/gal EC (EPA
Reg. No. 45639-197) formulations is limited to CA.
119
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Peas, succulent, Dry Peas
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
311 / i TJ/-\
Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
2 Ib/gal EC
[279-2659]
[279-2822]
Succulent Green Peas
Canceled
Dry Peas
l.Olb/A
l.Olb/A
Succulent Green
Peas Canceled
Dry Peas
2
2
OUCCU1C11L
Green Peas
Canceled
Dry Peas
2.0 Ib/A
2.0 Ib/A
Succulent
Green Peas
Canceled
Dry Peas
3
1
See "Bean, succulent and dry".
Use limited to the Northwest (EPA Reg. No. 279-2659).
Use limited on peas to be harvested by combine only.
Applications may be made in a minimum of 10 gal/A by
ground or 1 gal/A by air. The feeding of treated vines or
threshing to livestock or allowing livestock to graze in
treated fields is prohibited. *
Dry Peas
3 Ib/gal EC
[279-2924]
3 Ib/gal EC
[WI920007]
l.Olb/A
l.Olb/A
2 per fruiting
period
2 per fruiting
period
2.0 Ib/A
2.0 Ib/A
5
NS
Use limited on peas to be harvested by combine only.
Applications may be made in a minimum of 10 gal/A by
ground or 1 gal/A by air. The feeding of treated vines or
threshing to livestock or allowing livestock to graze in
treated fields is prohibited. *
Use limited to WI on peas to be harvested by combine
only. Applications may be made in a minimum of 10
gal/A by ground or 2 gal/A by air. The grazing of treated
fields or the feeding of treated forage or threshing to
livestock is prohibited. *
120
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Pecan
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
Canceled
Canceled
Canceled
Canceled
Endosulfan use on pecans is canceled
Pepper
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-1971
l.Olb/A
2
2.0 Ib/A
4
Require all wettable powders to be packaged in water
soluble bags. Reduce maximum seasonal application rate
from 31bs./ai/A to 21bs./ai/A.
121
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Pepper (continued)
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
l.Olb/A
2
2.0 Ib/A
4
Require all wettable powder formulations to be packaged
in water soluble bags. Reduce maximum seasonal
application rate from 31bs./ai/A to 21bs./ai/A Applications
may be made in a minimum of 10 gal/A by ground or 1
gal/A by air. Use of the 50% WP (EPA Reg. No. 45639-
198) and the 3 Ib/gal EC (EPA Reg. No. 45639-197)
formulations is limited to CA.
Pineapple
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-197]
2.0 Ib/A
2
3.0 Ib/A
7
Cancel use of WP formulation. Applications may be
made in a minimum of 10 gal/A by ground or 1 gal/A by
air with a 7- to 10-day pretreatment interval. The
feeding of treated forage or pineapple byproducts to
livestock is prohibited.* Use of the 3 Ib/gal EC (EPA
Reg. No. 45639-197) is limited to CA.
122
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Plum
Delayed dormant (during
pre-pink stage)
Ground or aerial
Prebloom or foliar (petal
fall)
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
ro^vn o/;cm
[279-2659]
[279-2822]
3 Ib/gal EC
ro^vn o no A ~\
[279-2924]
[45639-169]
[45639-197]
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
0.5 lb/100 gal
2.5 Ib/A
0.5 lb/100 gal
2.5 Ib/A
2
7
Z,
2.5 Ib/A
7 S lh/A
Z, . J 1 U/ .rt.
7
7
/
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation. Require
closed cabs for airblast applications. Use limited to the
Pacific Northwest. The grazing of livestock on treated
orchard crops or grasses in treated areas is prohibited. *
Use of the 50% WP (EPA Reg. No. 45639-198) and the 3
Ib/gal EC (EPA Reg. No. 45639-197) formulations is
limited to CA.
Reduce maximum application rate to 2.51bs./ai/A.
Require all wettable powder formulations to be packaged
in water soluble bags. Cancel aerial applications using
WP formulation. Require closed mixing/loading systems
for aerial applications using the EC formulation. Require
closed cabs for airblast applications The grazing of
livestock on treated orchard crops or grasses in treated
areas is prohibited. Use of the 50% WP (EPA Reg. No.
45639-198) and the 3 Ib/gal EC (EPA Reg. No. 45639-
197) formulations is limited to CA.
123
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Plum (continued)
Foliar treatment
Ground or aerial
Bark treatment
Postharvest
Ground
Bark treatment
Ground
50% WP
[45639-194]
[45639-198]
50% WP
[279-3129]
[45639-194]
[45639-198]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[45639-169]
[45639-197]
50% WP
[66222-22]
3 Ib/gal EC
[279-29241
0.75 lb/100 gal
2.5 Ib/A
0.75 lb/100 gal
2.5 Ib/A
0.75 lb/100 gal
2.5 Ib/A
2
2
2
2.5 Ib/A
0.005
Ibs/ai/gal
0.005
Ibs/ai/gal
7
7
7
The grazing of livestock on treated orchard crops or
grasses in treated areas is prohibited.* Use of the 50%
WP (EPA Reg. No. 45639-198) formulation is limited to
CA.
Reduce maximum application rate to 0.005 Ibs./ai/gal for
high pressure handwand and rights-of-way sprayer
scenarios. The grazing of livestock on treated orchard
crops or grasses in treated areas is prohibited.* Use of the
50% WP (EPA Reg. No. 45639-198) and the 3 Ib/gal EC
(EPA Reg. No. 45639-197) formulations is limited to
CA.
Reduce maximum application rate to 0.005 Ibs./ai/gal for
high pressure handwand and rights-of-way sprayer
scenarios. The grazing of livestock on treated orchard
crops or grasses in treated areas is prohibited. *
124
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Plum (continued)
Nursery stock dip
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
2 lb/40 gal
NS
NS
NA
Reduce maximum application rate of 0.005 Ibs./ai/A fro
high pressure handwand and rights-of-way sprayer
scenarios.
Potato
Foliar treatment
Ground or aerial
Chemigation
Sprinkler irrigation
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
3 Ib/gal EC
[WA9000231
l.Olb/A
l.Olb/A
4
NS
2.0 Ib/A
2.0 Ib/A
1
1
Require all wettable powder formulations to be packaged
in water soluble bags. Reduce maximum seasonal
application rate from 31bs./ai/A to 21bs./ai/A. Reduce
maximum number of applications per season from 6 to 4.
Applications may be made in a minimum of 10 gal/A by
ground or 1 gal/A by air. Use of the 50% WP (EPA Reg.
No. 45639-198) and the 3 Ib/gal EC (EPA Reg. No.
45639-197) formulations is limited to CA.
Use limited to WA.
125
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Prune
Delayed dormant (during
pre-pink stage)
Ground or aerial
Prebloom or foliar (petal
fall)
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
0.5 lb/100 gal
2.5 Ib/A
0.5 lb/100 gal
2.5 Ib/A
2
2
2.5 Ib/A
2.5 Ib/A
7
7
See "Plum".
See "Plum".
126
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Prune (continued)
Bark treatment
Postharvest
Ground
Bark treatment
Ground
Pumpkin
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[45639-169]
[45639-197]
50% WP
[66222-22]
3 Ib/gal EC
[279-2924]
50% WP
[279-3129]
[45639-194]
2 Ib/gal EC
[279-2659]
3 Ib/gal EC
[279-2924]
[45639-1691
3 Ib/gal EC
[45639-197]
0.75 lb/100 gal
2.5 Ib/A
0.75 lb/100 gal
2.5 Ib/A
l.Olb/A
l.Olb/A
2
2
4
4
0.005
Ibs./ai/gal
0.005
Ibs./ai/gal
2.0 Ib/A
2.0 Ib/A
7
7
2
2
Reduce maximum seasonal application rate to o.ooS
Ibs./ai/gal for high pressure handwand and rights-of-way
sprayer scenarios.
Reduce maximum seasonal application rate to o.ooS
Ibs./ai/gal for high pressure handwand and rights-of-way
sprayer scenarios.
See "Cucumber".
See "Cucumber".
127
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Radish (grown for seed)
Foliar treatment
Ground or aerial
50% WP
[WA780029]
3 Ib/gal EC
[OR770043]
[WA770016]
2.0 Ib/A
2
NS
NS
Require all wettable powder formulations to be packaged
in water soluble bags. Require closed mixing/loading
systems for aerial application using the EC formulation.
Cancel aerial application using the WP formulation.
Rutabaga (grown for seed)
Foliar treatment
Ground or aerial
50% WP
[WA780029]
3 Ib/gal EC
[OR770043]
[WA770016]
2.0 Ib/A
2
NS
NS
Require all wettable powder formulations to be packaged
in water soluble bags. Require closed mixing/loading
systems for aerial application using the EC formulation.
Cancel aerial application using the WP formulation.
Rye
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
0.75 Ib/A
1
l.Olb/A
NS
Cancel WP use. Require closed mixing/loading systems
for aerial application using EC formulation. Reduce
maximum number of applications from 2 per season to 1 .
128
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
50% WP
[279-3129]
[66222-22]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
Maximum Single
Application Rate
(ai)
0.75 Ib/A
Maximum
Number of
Applications Per
Season
2
Maximum
Seasonal Rate
(ai)
l.Olb/A
Preharvest
Interval
(Days)
NS
Use Directions and Limitations
Cancel WP use. Require closed mixing/loading systems
for aerial application using EC formulation. Reduce
maximum number of applications from 2 per season to 1 .
Spinach
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2735]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[45639-198]
3 Ib/gal EC
[45639-1971
Canceled
Canceled
Canceled
Canceled
Canceled
Canceled
Canceled
Canceled
Endosulfan use on spinach is canceled
Endosulfan use on spinach is canceled
129
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Squash, summer and winter
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[45639-198]
3 Ib/gal EC
[45639-197]
l.Olb/A
l.Olb/A
4
4
2.0 Ib/A
2.0 Ib/A
2
2
Require all wettable powder formulations to be packaged
in water soluble bags. Reduce the maximum seasonal
application rate from 31bs./ai/A to 21bs./ai/A. Reduce
maximum number of applications per season from 6 to 4.
Require all wettable powder formulations to be packaged
in water soluble bags. Reduce the maximum seasonal
application rate from 31bs./ai/A to 21bs./ai/A. Reduce
maximum number of applications per season from 6 to 4.
Strawberry
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
l.Olb/A
l.Olb/A
3
3
2.0 Ib/A
2.0 Ib/A
4
4
Reduce maximum application rate to 1 Ib./ai/A. Require
all wettable powder formulations to be packaged in water
soluble bags. Require closed mixing/loading systems for
aerial application using EC formulation. Cancel aerial
application suing WP formulation. Reduce maximum
seasonal application rate from 31bs./ai/A to 21bs./ai/A.
Reduce maximum number of applications from 3 per
season to 2 per season. Applications may be made in a
minimum of 10 gal/A by ground or 1 gal/A by air. Do
not reapply within 1 5 days or more than twice during a
35 day period when fruit is present. Use of the 50% WP
(EPA Reg. No. 45639-198) and the 3 Ib/gal EC (EPA
Reg. No. 45639-197) formulations is limited to CA.
Applications may be made in 400 gal. Do not apply at
intervals less than 35 days when fruit is present. Use of
the 50% WP (EPA Reg. No. 45639-198) and the 3 Ib/gal
EC (EPA Reg. No. 45639-197) formulations is limited to
CA.
130
-------
Site
Application Type
Application Timing
Application Equipment
Dip treatment
Formulation
[EPA Reg. No.]
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
Maximum Single
Application Rate
(ai)
l.Olb/lOOgal
Maximum
Number of
Applications Per
Season
NS
Maximum
Seasonal Rate
(ai)
NS
Preharvest
Interval
(Days)
NA
Use Directions and Limitations
Use limited to Northwest. Immerse bundles of plants;
drain and allow plants to dry before setting them out in
the field. Use of the 50% WP (EPA Reg. No. 45639-
198) and the 3 Ib/gal EC (EPA Reg. No. 45639-197)
formulations is limited to CA.
Sweet potato
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[66222-22]
3 Ib/gal EC
[279-2924]
[45639-169]
50% WP
[45639-198]
3 Ib/gal EC
[45639-197]
50% WP
[MS8 10036]
3 Ib/gal EC
[MS8100351
l.Olb/A
l.Olb/A
0.5 Ib/A
32
2
NS
l.Olb/A
l.Olb/A
NS
1
1
NS
Cancel WP use. Require closed mixing/loading systems
for aerial application using the EC formulation. Reduce
maximum seasonal applications rate from 31bs./ai/A to
21bs./ai/A. Reduce maximum number of applications per
season from 3 to 2. The feeding of cull potatoes to
livestock or the grazing of livestock in treated fields is
prohibited.*
Use limited to CA. The feeding of cull potatoes to
livestock or the grazing of livestock in treated fields is
prohibited.*
Use limited to MS. The feeding of treated potatoes to
livestock is prohibited. *
131
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Sweet potato (continued)
Soil band or broadcast
Ground or aerial
Soil treatment
Ground or aerial
50% WP
[279-3129]
[66222-22]
3 Ib/gal EC
[279-2924]
[45636-169]
50% WP
[MS8100036]
3 Ib/gal EC
[MS810035]
2.0 Ib/A
(broadcast)
0.67-0.75 Ib/A based
on a 16 inch band
with a 48 inch row
spacing
2.0 Ib/A
1.51b/A
2
NS
NS
2.0 Ib/A
NS
NS
1
NS
NS
Use limited to South central states and PR. The feeding
of cull potatoes to livestock or the grazing of livestock in
treated fields is prohibited. *
Use limited to MS. The feeding of treated potatoes to
livestock is prohibited. *
Tobacco
Foliar treatment
Seed bed
Ground
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-1691
0.5 lb/100 gal
[6 gal of finished
spray 11 00 sq. yd]
2
2.0 Ib/A
5
Cancel WP use. Reduce maximum seasonal application
rate from 31bs./ai/A to 2 Ibs./ai/A. Reduce maximum
number of applications per season from 6 to 2. Restrict
use on tobacco to the following states: IN, KY, OH, PA,
and WV.
132
-------
Site
Application Type
Application Timing
Application Equipment
Drench treatment
Plant bed
Ground
Formulation
[EPA Reg. No.]
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
Maximum Single
Application Rate
(ai)
0.25 lb/100 gal
[1 gal of finished
spray /sq. yd]
Maximum
Number of
Applications Per
Season
2
Maximum
Seasonal Rate
(ai)
2.0 Ib/A
Preharvest
Interval
(Days)
5
Use Directions and Limitations
Cancel WP use. Reduce maximum seasonal application
rate from 31bs./ai/A to 2 Ibs./ai/A. Reduce maximum
number of applications per season from 6 to 2. Restrict
use on tobacco to the following states: IN, KY, OH, PA,
and WV.
Tobacco (continued)
Foliar treatment
Field
Ground
50% WP
[279-3129]
[45639-194]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
l.Olb/A
1.5 lb/100 gal
l.Olb/A
0.5 lb/100 gal
2
2
2.0 Ib/A
l.Olb/A
5
5
Cancel WP use. Reduce maximum seasonal application
rate from 31bs./ai/A to 2 Ibs./ai/A. Reduce maximum
number of applications per season from 6 to 2. Restrict
use on tobacco to the following states: IN, KY, OH, PA,
and WV.
133
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Tomato (field)
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
l.Olb/A
0.5 lb/100-200 gal
2
2.0 Ib/A
2
Cancel WP use. Reduce maximum seasonal application
rate from 3 Ibs./ai/A to 2 Ibs./ai/A. Reduce maximum
number of applications per season from 6 to 4.
Applications may be made in a minimum of 10 gal/A by
ground or 1 gal/A by air. Use of the 50% WP (EPA Reg.
No. 45639-198) and the 3 Ib/gal EC (EPA Reg. No.
45639-197) formulations is limited to CA.
Tomato (greenhouse)
Foliar treatment
Ground
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2735]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
[45639-197]
l.Olb/A
0.5 lb/100-200 gal
4
0.005
Ibs/ai/gal
2
Reduce maximum application rate to 0.005 Ibs./ai/gal for
high pressure handwand and rights-of-way sprayers.
Applications may be made in a minimum of 10-25 gal/A
by ground. Use of the 50% WP (EPA Reg. No. 45639-
198) and the 3 Ib/gal EC (EPA Reg. No. 45639-197)
formulations is limited to CA.
134
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications Per
Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Directions and Limitations
Turnip
Foliar treatment
Ground or aerial
2 Ib/gal EC
[279-2659]
[279-2822]
0.75 Ib/A
1
0.75 Ib/A
21
Reduce maximum application rate to 0.75 Ibs/ai/A.
Require all wettable powders to be packaged in water
soluble bags. Applications may be made in a minimum of
10 gal/A by ground or 1 gal/A by air. Application to
turnips grown for roots is prohibited.*
Turnip (grown for seed)
Foliar treatment
Ground or aerial
50% WP
[WA780029]
3 Ib/gal EC
[OR770043]
[WA770016]
2 0 Ib/A
2
NS
NS
Require all wettable powder formulations to be packaged
in water soluble bags. Require closed mixing/loading
systems for aerial application using the EC formulation.
Cancel aerial application using the WP formulation.
Walnut
Foliar treatment
Ground or aerial
50% WP
[279-3129]
[45639-194]
[45639-198]
[66222-22]
2 Ib/gal EC
[279-2659]
[279-2822]
3 Ib/gal EC
[279-2924]
[45639-169]
2.0 Ib/A
2.0 Ib/A
2
2
2.0 Ib/A
2.0 Ib/A
NS
NS
Require all wettable powders to be packaged in water
soluble bags. Cancel aerial application using the WP
formulation. Require closed mixing/loading systems for
aerial application using the EC formulation. Require
closed cabs for airblast application. Reduce maximum
seasonal application rate from 2 per season to 1 . Reduce
maximum seasonal application rate from 31bs./ai/A to 2
Ibs./ai/A Applications may be made in a minimum of 10
gal/A by ground or 1 gal/A by air. The grazing of
livestock on orchard crops or grasses in treated areas and
application after husk split are prohibited.* Use of the
50% WP (EPA Reg. No. 45639-198) formulation is
limited to CA
NS = Not Specified
135
-------
Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision
GUIDE TO APPENDIX B
Appendix B contains listing of data requirements which support the reregistration for active ingredients within case
#0014 (endosulfan) covered by this RED. It contains generic data requirements that apply to endosulfan in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following formats:
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 Guidance, 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 list the
identify number of each study. This normally is the Master Record
Identification (MIRD) 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.
136
-------
Appendix B. Data Supporting Guideline Requirements for the
Reregistration of Endosulfan
New
Guideline
Number
Old
Guideline
Number
Requirement
Use Pattern
Bibliographic Citation(s)
PRODUCT CHEMISTRY
830.1550
830.1600
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
830.7550
830.7000
830.6313
830.6314
830.6314
830.6316
830.6316
830.7100
830.6319
830.6320
830.7050
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
None
Product Identity and
Composition
Start. Mat. & Mfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
Coefficient
PH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
UV/Visible Absorption
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
00128650, 42932001, 42932002, 42932003, 42932004,
42932005, 42932006, 42932007
00128650, 42932001, 42932002, 42932003, 42932004,
42932005, 42932006, 42932007
00128650, 42932001, 42932002, 42932003, 42932004,
42932005, 42932006, 42932007
00128662,42919102
00128650, 42932001, 42932002, 42932003, 42932004,
42932005, 42932006, 42932007
00128662, 42932001, 42932002, 42932003, 42932004,
42932005, 42932006, 42932007
00128650, 00128657
00128650, 00128657
00128650, 00128657
00128657
00128657
00128657
00128657
00128657
Not Applicable
00128657
00128657
00128657
00128650
00128650
00128650
00128650
00128650
00128650
00128650
Not Applicable
ECOLOGICAL EFFECTS
850.2100
850.2100
71-1 A
None
Avian Acute Oral Toxicity
(Quail or Duck)
Avian Acute Oral Toxicity
of Bobwhite Quail and
Mallard Duck (Endosulfan
Sulfate)
A,B,C
A,B,C
137189,00136998,00137189
DATA GAP
137
-------
Appendix B. Data Supporting Guideline Requirements for the
Reregistration of Endosulfan
New
Guideline
Number
850.2200
850.2200
850.2200
850.2400
850.2300
850.2300
850.2300
850.2300
850.1075
850.1075
850.1075
850.1010
NONE
850.1075
850.1025
850.1035
850.1300
850.1350
850.1035
850.1500
Old
Guideline
Number
71-2A
None
71-2B
71-3
7 1-4 A
71-4B
71-4 (A)
71-4 (B)
72-1 A
None
72- 1C
72-2A
72-3A
None
72-3B
72-3C
72-4A
72-4B
None
72-5
Requirement
Avian Dietary Toxicity -
Quail
Avian Subchronic Oral
Toxicity of Bobwhite Quail
and Mallard Duck
(Endosulfan Sulfate)
Avian Dietary Toxicity -
Duck
Wild Mammal Toxicity
Avian Reproduction - Quail
Avian Reproduction - Duck
Avian Reproduction -
Quail
(Endosulfan Sulfate)
Avian Reproduction -
Duck
(Endosulfan Sulfate)
Fish Toxicity Bluegill
Freshwater Fish Acute
Toxicity Bluegill Sunfish
(Endosulfan Sulfate)
Fish Toxicity Rainbow
Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity -
Fish
Estuarine /Marine Fish
Acute Toxicity Study
(Endosulfan Sulfate)
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
Fish- Early Life Stage
Estuarine/Marine
Invertebrate Life Cycle
Estuarine/Marine
Invertebrate Acute Toxicity
Study of Mysid Shrimp
(Endosulfan Sulfate)
Life Cycle Fish
Use Pattern
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
Bibliographic Citation(s)
22923
DATA GAP
22923
00038307, 00148264
40261303
40261302, 40335001, 40335002, 146843
DATA GAP
DATA GAP
38806, 40094602,
DATA GAP
40098001,00136998
5008271, 40098001, 40094602
40228401
DATA GAP
40228401, 128688
40228401, 128688
DATA GAP
DATA GAP
DATA GAP
DATA GAP
138
-------
Appendix B. Data Supporting Guideline Requirements for the
Reregistration of Endosulfan
New
Guideline
Number
850.1500
850.1735
850.1740
850..1735S
850.1740S
Special Study
Special Study
164-2SS
835.7100
835.7200
850.4230
850.4400
Old
Guideline
Number
None
None
None
None
None
None
None
None
None
None
123-1
123-2
Requirement
Freshwater Fish Full Life
Cycle Using Rainbow Trout
(Endosulfan Sulfate)
Whole Sediment Acute
Toxicity Testing Using
Freshwater Invertebrate
Whole Sediment Acute
Toxicity Testing Using
Estuarine/Marine
Invertebrate
Whole Sediment Chronic
Toxicity Testing Using
Freshwater Invertebrate
Whole Sediment Chronic
Toxicity Testing Using
Estuarine/Marine
Invertebrate
Tissue Residue Toxicity
Study in Fish
Tissue Residue Toxicity
Study in Amphibians
Vegetative Buffer
Effectiveness Study
Groundwater Monitoring
Surfacewater Monitoring
Non-target Terrestrial Plant
Phytotoxicity
Aquatic Plant Growth
Use Pattern
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A3,C
A3,C
Bibliographic Citation(s)
DATA GAP
DATA GAP
DATA GAP
DATA GAP
DATA GAP
RESERVE
RESERVE
DATA GAP
DATA GAP
DATA GAP
Not Applicable
Not applicable
OCCUPATIONAL/RESIDUE EXPOSURE
875.2100
875.2200
875.2400
NONE
NONE
NONE
NONE
NONE
NONE
132-1 (a)
132-1B
133-3
133-4
201-1
202-1
231
232
85-3
Foliar Residue Dissipation
Soil Residue Dissipation
Dermal Passive Dosimet
Inhalation Passive Dosimet
Droplet Size Spectrum
Drift Field Evaluation
Estimation of Dermal
Exposure
Estimation of Inhalation
Exposure
Dermal Absorption
A3,C
A,B,C
A3,C
A3,C
A,B,C
A3,C
A3,C
A3,C
44403102
Not Applicable
Not Applicable
WAIVED
Not Applicable
Not applicable
41715201,44939101
41715201
40223601, 41048503, 41048504
139
-------
Appendix B. Data Supporting Guideline Requirements for the
Reregistration of Endosulfan
New
Guideline
Number
875.1100
875.1700
Old
Guideline
Number
None
None
Requirement
Dermal Outdoor Exposure
For Applying Dip
Treatments to Trees, Roots,
and Whole Plants
Product Use Information for
Applying Dip Treatments to
Trees, Roots, and Whole
Plants
Use Pattern
A,B,C
A,B,C
Bibliographic Citation(s)
DATA GAP
DATA GAP
TOXICOLOGY
870.1100
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.6100
870.6200
870.6200
870.6300
870.3100
870.3150
870.3200
NONE
NONE
NONE
870.4100
870.4100
870.4200
870.4200
870.3700
81-1
81-1
81-2
81-3
81-4
81-5
81-6
81-7
81-8
82-7
83-6
82-1 A
82- IB
82-2
82-4
82-5A
82-5B
83-1A
83-1B
83-2A
83-2B
83-3A
Acute Oral Toxicity-Rat
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-
Rabbit/Rat
Acute Inhalation Toxicity-
Rat
Primary Eye Irritation-
Rabbit
Primary Skin Irritation
Dermal Sensitization
Acute Delayed
Neurotoxicity - Hen
Acute Neurotoxicity Screen
Subchronic Neurotoixicity -
Rat
Developmental
Neurotoxicity Study - Rat
90-Day Feeding - Rodent
90-Day Feeding - Non-
rodent
21 -Day Dermal - Rabbit/Rat
90 Day Inhalation-Rat
90 Day Neurotox -Hen
90 Day Neurotox - Mammal
Chronic Feeding Toxicity -
Rodent
Chronic Feeding Toxicity -
Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity -
Rat
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
00038307,41183502
00038307,41183502
41183503
41183504
255157,41183505
00038309,00128649,41183506
00136994,41183507
00147181, 44403101, 44560701, 44560702
44403101
DATA GAP
DATA GAP
00257932, 00257727, 00147299, 40767601, 41775501
00147182,40648801
00146841, 00147744, 41048505, 41048506
00147183, 41667501, 41667502, 41667503
RESERVED
RESERVED
41099502
41099501
41099501,41099502
40792401
43129101
140
-------
Appendix B. Data Supporting Guideline Requirements for the
Reregistration of Endosulfan
New
Guideline
Number
870.3700
870.3800
870.4300
870.5140
870.5375
870.7485
Old
Guideline
Number
83-3B
83-4
83-5
84-2A
84-2B
84-4
85-1
Requirement
Developmental Toxicity -
Rabbit
2-Generation Reproduction
-Rat
Combined Chronic
Toxicity/ Carcinogenicity
Gene Mutation (Ames Test)
Structural Chromosomal
Aberration
Other Genotoxic Effects
General Metabolism
Use Pattern
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
A,B,C,H
Bibliographic Citation(s)
00094837
00256126, 00256127, 00257727, 00148264
41099502
00147199,00148266
00147197,00148265
00147198
00004257
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.2370
835.4100
835.4200
835.1240
NONE
835.6100
860.1850
860.1900
NONE
161-1
161-2
161-3
161-4
162-1
162-2
163-1
163-2
164-1
165-1
165-2
165-4
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Photodegradation - Air
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Leaching/Adsorption/Desor
ption
Volatility-Lab
Terrestrial Field Dissipation
Confined Rotational Crop
Field Rotational Crop
Bioaccumulation in Fish
A,C,H
A,C,H
A,C,H
A,C,H
A,C,H
A,C,H
A,C,H
A,C,H
A,C,H
A,C,H
A,C,H
A,C,H
00150714, 00142649, 00128661, 00128557, 00128659,
41412901
00253395, 41415701, 41490101
00128660, 00142640, 00150714, 41430701
WAIVED
00148993, 41412902, 43812801
00136884, 41412903, 41412904
00137002, 00137162, 00137446, 41412905, 44346901
00252043,40060601
00137003, 00137161, 41309701, 41309702, 41468601,
43069701
44393001
DATA GAP
41421503
RESIDUE CHEMISTRY
NONE
860.1300
860.1300
860.1340
860.1340
860.1360
860.1380
171-2
171-4A
171-4B
171-4C
171-4D
171-4M
171-4E
Chemical Identity
Nature of Residue - Plants
Nature of Residue -
Livestock
Residue Analytical Method
-plants
Residue Analytical Method-
Animal
Multiresidue Methods
Storage Stability
A,B
A,B
A,B
A,B
A,B
A,B
Not Applicable
00003600, 00003642, 00003654, 05002565, 05003004,
05003085, 05003336, 05003801, 05004385, 05004620,
05018169, 44082701, 44082702, 44099101
00003742, 00003743, 00003838, 00003840, 05003222,
05003877, 44082703, 44099101, 440099102, 44427601
00003588, 00003612, 00003795, 00003959, 05003395,
GS014024, 00146842, 00157147, 00157148, 44346902
00003703, 00003840, 44427601
44427601
44396301, 44599600, 44599601, 44637800
141
-------
Appendix B. Data Supporting Guideline Requirements for the
Reregistration of Endosulfan
New
Guideline
Number
860.1380
860.1480
860.1500
860.1500
860.1500
Old
Guideline
Number
171-4E
171-4J
171-4K
171-4K
171-4K
Requirement
Storage Stability
Meat, Milk, Poultry, Eggs
Milk and the Fat, Meat, and
Meat Byproducts of Cattle,
Goats, Hogs, Horses and
Sheep
Eggs and the Fat, Meat, and
Meat Byproducts of Poultry
Crop Field Trials (Carrot)
Crop Field Trials (Potato)
Crop Field Trials (Sweet
Potato)
Use Pattern
A,B
A,B
A,B
A,B
A,B
Bibliographic Citation(s)
DATA GAP - oils seed, non-oily grain and processed
commodities
44843702
00003742, 00003743, 00003838, 05003222, 05003877,
05013696
00003840, 44843702
00003796
00003709
00003642, 00003669, 44346912
Leaves of Root and Tuber Vegetables Group
860.1500
171-4K
Turnip, Tops
A,B
00003796
Leafy Vegetables (except Brassica) Vegetables Group
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
Crop Field Trials (Celery)
Crop Field Trials (Lettuce,
Leaf)
Crop Field Trials (Spinach)
A,B
A,B
A,B
00003796, 44346906, 44701201
00003722, 00003790, 44346904, 44701202
00003796
Brassica (Cole) Vegetables Group
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
Crop Field Trials (Broccoli)
Crop Field Trials (Brussels
Sprouts)
Crop Field Trials (Cabbage)
Crop Field Trials
(Cauliflower)
Crop Field Trials (Collards)
Crop Field Trials (Collards,
Grown for Seed)
Crop Field Trials (Kale)
Crop Field Trials (Mustard
Greens)
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
00003796, 44346908
00003796
00003790
00003796
00003796
Not Applicable
00003796
00003796
Legume Vegetables Group
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
Crop Field Trials (Bean,
Dry and Succulent)
Crop Field Trials (Eggplant)
Crop Field Trials (Pea,
Succulent)
A,B
A,B
A,B
00003796
00003796
00003917, 00003949
142
-------
Appendix B. Data Supporting Guideline Requirements for the
Reregistration of Endosulfan
New
Guideline
Number
860.1500
860.1500
860.1500
Old
Guideline
Number
171-4K
171-4K
171-4K
Requirement
Crop Field Trials (Pea,
Grown for Seed)
Crop Field Trials (Pepper)
Crop Field Trials
(Tomatoes)
Use Pattern
A,B
A,B
A,B
Bibliographic Citation(s)
00003917, 00003949
00003864
00003783, 00146842, 44346905
Cucurbit Vegetables Group
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
Crop Field Trials
(Cucumber)
Crop Field Trials (Melons,
Cantaloupe)
Crop Field Trials (Melons,
Musk)
Crop Field Trials
(Melons, Water)
Crop Field Trials (Pumpkin)
Crop Field Trials
(Squash, Summer)
Crop Field Trials (Squash,
Winter)
A,B
A,B
A,B
A,B
A3
A,B
A,B
00146842,44346909
00146842,44346903
00146842,44346903
00146842,44346903
00146842, 44346909, 44346903, 44346907
00146842,44346907
00146842,44346907
Pome Fruits Group
860.1500
860.1500
171-4K
171-4K
Crop Field Trials (Apple)
Crop Field Trials (Pear)
A,B
A,B
00003787
00003862
Stone Fruits Group
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
Crop Field Trials (Cherry)
Crop Field Trials (Peach)
Crop Field Trials (Plume,
Fresh Prune)
A,B
A,B
A,B
00003782, 44346910, 4434691 1
00003784, 00003789
00003786, 00003791
Berries Group
860.1500
171-4K
Crop Field Trials
(Blueberry)
A,B
00003587, 00003843
Tree Nuts Group
860.1500
860.1500
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
171-4K
171-4K
Crop Field Trials (Almond,
Nutmeat and Hulls)
Crop Field Trials (Filbert)
Crop Field Trials
(Macadamia Nut)
Crop Field Trials (Pecan)
Crop Field Trials (Walnut)
A,B
A,B
A,B
A,B
A,B
00003713,00004254
00004254
00004254
00004254
00004254
Cereal Grains Group
860.1500
171-4K
Crop Field Trials (Barley,
Grain)
A,B
00003710
143
-------
Appendix B. Data Supporting Guideline Requirements for the
Reregistration of Endosulfan
New
Guideline
Number
860.1500
860.1500
860.1500
860.1500
Old
Guideline
Number
171-4K
171-4K
171-4K
171-4K
Requirement
Crop Field Trials (Corn,
Sweet, K + CWHR)
Crop Field Trials (Oats,
Grain)
Crop Field Trials (Rye,
Grain)
Crop Field Trials (Wheat,
Grain and Aspirated Grain
Fractions)
Use Pattern
A,B
A,B
A,B
A,B
Bibliographic Citation(s)
00003634, 00003760, 44457001
00003710
00003710
00003710
Forage, Fodder, and Straw of Cereal Grains Group
860.1500
860.1500
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
171-4K
171-4K
Crop Field Trials Barley,
Hay and Straw
Crop Field Trials (Corn,
Sweet, Forage and Stover)
Crop Field Trials (Oats,
Forage, Hay and Straw)
Crop Field Trials (Rye,
Forage and Straw)
Crop Field Trials (Wheat,
Forage, Hay, and Straw)
A,B
A,B
A,B
A,B
A,B
00003710, DATA GAP
44457001
00003710
00003710, DATA GAP
00003710,44762901
Non-Grass Animal Feeds (Forage, Fodder, Straw, and Hay) Group
860.1500
171-4K
Crop Field Trials (Alfalfa,
Forage and Hay)
A,B
00003834, 00003835, 00003836, 00003841, 00004258,
00157148
Miscellaneous Commodities
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
Crop Field Trials (Cotton,
Seed and Gin Byproducts)
Crop Field Trials (Grape)
Crop Field Trials
(Pineapple)
Crop Field Trials (Rape,
Seed and Forage)
Crop Field Trials
(Strawberry)
Crop Field Trials (Tobacco)
A,B
A,B
A,B
A,B
A,B
A,B
00003725, 00003777, 44854101, 44854102, 44854103
00003788
00003797, 00003798, 00003799
00003724
00003785
05003004, 05003801, DATA GAP
Processed Food/Feed
860.1520
860.1520
860.1520
171-4L
171-4L
171-4L
Processed Food (Apple)
Processed Food (Barley)
Processed Food (Cotton
Seed)
A3
A3
A3
00156259,44933001
DATA GAP
00003726
144
-------
Appendix B. Data Supporting Guideline Requirements for the
Reregistration of Endosulfan
New
Guideline
Number
860.1520
860.1520
860.1520
860.1520
860.1520
860.1520
860.1520
Old
Guideline
Number
171-4L
171-4L
171-4L
171-4L
171-4L
171-4L
171-4L
Requirement
Processed Food (Grapes)
Processed Food (Oats)
Processed Food (Pineapple)
Processed Food (Potato)
Processed Food (Rye)
Processed Food (Tomato)
Processed Food (Wheat)
Use Pattern
A,B
A,B
A,B
A,B
A,B
A.B
A,B
Bibliographic Citation(s)
00156259,44346915
DATA GAP
00146997, 00156259, 00157147
44346913
DATA GAP
00146842, 44346914
44762901
OTHER
860.1850
860.1900
NONE
NONE
Confined Rotational Crops
Field Rotational Crops
A,B,C
A,B,C
44933001
44972301
145
-------
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP Public
Regulatory Docket, located in Room 119, Crystal Mall #2, 1921 Jefferson Davis Highway,
Arlington, VA 22202-4501. It is open Monday through Friday, excluding legal holidays, from
8:30 AM to 4PM.
The docket initially contained preliminary human health & ecological effects risk
assessments and related documents as of 09/13/2001. The public comment period closed sixty
(60) days later on 11/13/2001. The EPA then considered comments, reevaluated the retention of
the FQPA lOx Safety Factor and revised the occupational risk assessment. The Agency also
reevaluated the toxicological endpoint selection for dermal and inhalation risk assessments and
the 3x safety factor for bioaccumulation. The following documents were added to the docket
and posted to the webpage on 3/15/2002. All documents, in hard copy form, may be viewed in
the OPP docket room or downloaded/viewed via the Agency's website at
http://www.epa.gov/pesticides/reregistration/endosulfan/. These documents include:
Health Effects Risk Assessment Documents:
1. Re-Evaluation of Toxicology Endpoint Selection for Dermal and Inhalation Risk
Assessments and 3X Safety Factor for Bioaccumulation, February 7, 2002.
2. Revised Residue Chemistry Chapter For The Endosulfan Reregi strati on Eligibility
Decision (RED) Document, February 14, 2002.
3. Report of the FQPA Safety Factor Committee, February 14, 2002.
4. Third Revision of Occupational and Residential Exposure Assessment and
Recommendations for the Reregi strati on Eligibility Decision Document, February 26,
2002.
5. Anticipated Residues and Revised Chronic Dietary Exposure Analyses, February 28,
2002.
6. New FQPA and PDF Data, Anticipated Residues, and Revised Acute and Chronic
Dietary Exposure Analyses, April 22, 2002.
7. Response to Registrant Comments on the Data Supporting the FQPA Safety Factor
Rationale for Endosulfan
Health Effects Risk Assessment Documents Added to the Endosulfan Docket on 09/30/2002:
8. Response to Comments. Response to comments on EPA's Human Health Risk
Assessment of Endosulfan dated 01/31/2001.
9. Endosulfan. Agency Response to the 60-Day Response by the Endosulfan Task Force to
the Revised Residue Chemistry Chapter dated January 31, 2002.
10. Revised Residue Chemistry Chapter for the Endosulfan Reregi strati on Eligibility
Decision (RED) Document, 2/14/2002.
146
-------
11. Supporting documentation for findings of FQPA Safety Committee on February 11,
2002, May 9, 2002
12. Endosulfan. Review of Endosulfan Task Force Response to the Health Effects Division
February 28, 2002 Dietary Exposure Assessment dated, 6/14/2002
13. New FQPA, PDF, and Processing Data, Anticipated Residues, and Revised Acute and
Chronic Dietary Exposure Analyses, July 19, 2002
14. Response to Registrant Comments on the Data Supporting the FQPA lOx Safety
Factor Rationale for Endosulfan, August 12, 2002.
Environmental Fate and Ecological Effects
15. Final EFED Risk Assessment for the Reregi strati on Eligibility Decision on Endosulfan,
February 26, 2002.
16. Endosulfan and Endosulfan Sulfate: Drinking Water EECs in Surface Water for Use in
the Human Health Risk Assessment, July 3, 2002.
17. EFED Response to the ETF "60-Day Response by the Endosulfan Task Force to the
Environmental Fate and Effects Drafted Risk Assessment for the Reregi strati on
Eligibility Decision on Endosulfan (EFED Memorandum dated July 12, 2001)"
18. EFED Response to Comments by the World Wildlife Federation on the Environmental
Fate and Ecological Risk assessment for the Reregi strati on Eligibility Decision on
Endosulfan
19. EFED Response to Comments by the National Resource Defense Council Environmental
Fate and Ecological Risk assessment for the Reregi strati on Eligibility Decision on
Endosulfan
Biological and Economic Analysis of Endosulfan Benefits Assessments
20. Benefits Assessment for Endosulfan Use in Sweet Potato, 4/15/2002
21. Biological And Economic analysis of Endosulfan on Pears: Impacts from Changes in the
Re-entry Interval, 4/18/2002
22. Benefits Assessment for Endosulfan Use on Broccoli: Impacts from Changes in the Re-
entry Interval, 4/18/2002
23. Biological and Economic Analysis of Endosulfan on Peaches: Impacts from Changes in
the Re-entry Interval, 4/24/2002
24. Biological and Economic Analysis of Endosulfan on Grapes: Impacts from Changes in
the Re-entry Interval, 5/30/2002
25. Biological and Economic Analysis of Endosulfan on Blueberries: Impacts from Changes
in the Re-entry Interval, 5/23/2002
26. Biological and Economic Analysis of Endosulfan on Fresh Sweet Corn: Impacts from
Changes in the Re-entry Interval, 6/27/2002
147
-------
27. Biological and Economic Analysis of Endosulfan Benefits on Selected Crops: Impacts of
Cancellation, 7/12/2002
28. Assessment of Endosulfan Use in Seed Alfalfa: Application Rate Reduction to Reduce
Risks to Mixers/Loaders, 7/26/2002
29. Biological and Economic Analysis of Endosulfan on Cabbage: Impacts from Changes in
the Re-entry Interval, 8/8/2002
148
-------
Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography)
GUIDE TO APPENDIX D
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.
149
-------
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 as (1999),
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.
150
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00003585 Oregon State University—Corvallis, Cooperative Extension Service (1963)
Control of sugar beet insect pests. Page 133,~In~Oregon Insect Control
Handbook. Corvallis: O.S.U. (Also-In-unpublished submission received Aug
31, 1964 under 279-1182; submission Philadelphia, Pa.; CDL:008878-A)
00003586 Brogdon, I.E.; Marvel, M.E. (1959) Commercial Vegetable Insect and Disease
Control Guide. Gainesville, Fla.: Agricultural Extension Service. (Circular 193;
also~In~unpublished submission received Sep 25, 1959 under 279-1182;
submitted by FMC Corp., Philadelphia, Pa.; CDL:224560-A)
00003587 Shuttleworth, J.M. (1971) Determination of Endosulfan I, Endosulfan II, and
Endosulfan Sulfate Residues in or on Blueberries. Method M-2908 dated Aug 17,
1971. (Unpublished study received Aug 27, 1971 under IF 1034; submitted by
FMC Corp., Philadelphia, Pa.; CDL:093343-A)
00003588 FMC Corporation (1969) Analytical Method and Residues: [Endosulfan].
(Unpublished study received Sep 3, 1970 under 1F1034; CDL:093343-D)
00003592 Shuttleworth, J.M. (1970) Development of an Analytical Method for
Determining Endosulfan and Endosulfan Sulfate Residues in or on
Small Grains. Method M-2653 dated May 5, 1970. (Unpublished
study received Aug 18, 1970 under IF 1028; submitted by FMC
Corp., Philadelphia, Pa.; CDL:093338-C)
00003600 FMC Corporation (1958) Petition for the Establishment of a Tolerance for
Thiodan on Strawberry and Peach...Including a Description of the Analytical
Methods Used. (Unpublished study including supplement, received Feb 9, 1960
under PP0237; CDL: 090265-A)
00003634 Stanovick, R.P. (1967) Determination of Thiodan I, II and Sulfate Residues in or
on Sweet Corn (Husk, Cob and Kernels): M-2129. Includes undated method.
(Unpublished study received Jun 14, 1967 under 279-1182; submitted by FMC
Corp., Philadelphia, Pa.; CDL:008892-A)
151
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00003642 FMC Corporation (1964) Thiodan: Analytical Method and Residue Data in or on
Sweet Potatoes. Includes method dated Feb 14, 1964. (Unpublished study
received Feb 18, 1964 under unknown admin, no.; CDL:119693-A)
00003654 Ware, G.W.; Myser, W.C.; Treece, R.E.; Carey, W.E.; Terranova, A.C. (1961)
Final Report: The Determination of 14C-tagged Thiodan Residues on Alfalfa:
State Special Project #112. (Unpublished study received Jun 6, 1962 under
PP0373; prepared in cooperation with Ohio Agricultural Experiment Station,
submitted by FMC Corp., Philadelphia, Pa.; CDL:090402-D)
00003703 FMC Corporation (1970) Thiodan: Analytical Method for Milk and Tissues:
Supplemental Information to Niagara Report M-1656. (Unpublished study
received Aug 24, 1967 under 8F0632; CDL:092926-D)
00003709 FMC Corporation (1969) (Foliar Application of Endosulfan on Potatoes).
(Unpublished study received May 30, 1970 under OF0925; CDL:091579-B)
00003710 FMC Corporation (1970) Results of Tests of the Amount of Residues Remaining
and Description of Analytical Method: (Endosulfan). (Unpublished study
received Sep 6, 1971 under 1F1028; CDL:091905-B)
00003713 FMC Corporation (1971) Results of Tests of the Amount of Residues Remaining
and Description of Analytical Method: (Endosulfan). (Unpublished study
received Nov 17, 1972 under 3F1314; CDL: 092246-C)
00003721 Hinstridge, P.A. (1968) Project No. and Title: 015-Thiodan and
Thiodan Sulphate Residues in Refined Soybean Oil: R-1086. In-
cludes method dated Jan 29, 1968. (Unpublished study received
Jan 17, 1969 under 8F0723; submitted by FMC Corp., Philadelphia,
Pa.; CDL:091250-S)
00003722 Hinstridge, P.A. (1966) Project No. and Title: 015-Thiodan and Thiodan
Sulphate Residues on Leaf Lettuce: R-993. Includes method dated Aug 9, 1966.
(Unpublished study received Jan 17, 1969 under 8F0723; submitted by FMC
Corp., Philadelphia, Pa.; CDL:091250-T)
152
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00003723 IR-4 Project at Rutgers, the State University (19??) Summary:
Crop—Dosages—Applications—Interval—Residue—Recovery: (Endo-
sulfan and Parathion on Mustard Seed and Rape Seed.) Summary of
study 092201-B. Includes undated method. (Unpublished study
received Aug 11, 1972 under 3E1300; CDL:092201-A)
00003724 Winterlin, W. (1968) Residues Found on Mustard and Rape Seed. Includes
undated method. (Unpublished study received Aug 11, 1972 under 3E1300;
prepared by Univ. of California—Davis, Dept. of Environmental Toxicology,
submitted by Interregional Research Project No. 4, New Brunswick, N.J.;
CDL: 092201-B)
00003725 FMC Corporation (1966) [Residue Data of Endosulfan on Cotton]. (Unpublished
study received Jun 8, 1970 under OF0929; CDL:091584-B)
00003726 FMC Corporation (1969) Endosulfan Cotton: Processing Studies. (Unpublished
study received Jun 8, 1970 under OF0929; prepared in cooperation with Texas A
& M Univ., Cottonseed Products Laboratory, CDL:091584-D)
00003727 FMC Corporation (1967) [Residues of Endosulfan on Safflower Seed]. Includes
undated method. (Unpublished study received Jun 8, 1970 under OF0929;
CDL:091584-E)
00003728 Shuttleworth, J.M. (1971) Determination of Endosulfan and Endosulfan Sulfate
Residues in Sugar Beet Roots and Sugar Beet Pulp: M-2866. Includes undated
method. (Unpublished study including letter dated Sep 10, 1971 from P.J.
Boughton to William H. Morgan, received Jul 2, 1971 under 1F1058; submitted
by FMC Corp., Philadelphia, Pa.; CDL:093371-E)
00003741 Baran, J. (1967) Report to Niagara Chemical Division, FMC Corpora-
tion: Two-Year Chronic Oral Toxicity of Thiodan Technical—Bea-
gle Dogs: IBT No. C3758. (Unpublished study including letter
dated Dec 5, 1967 from J.C. Calandra to John F. McCarthy, re-
ceived Dec 7, 1967 under 7F0632; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by FMC Corp., Philadelphia, Pa.;
CDL: 091100-A)
153
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00003742 Maier-Bode, H. (1966) Summary of the Results of Residue Tests after Feeding
Endosulfan-(Thiodan) and DDT-Active Ingredient to Pigs. (Translated from
German; unpublished study received Dec 7, 1967 under 7F0632; prepared by
Pharmakologisches Institut der Rheinischen Friedrich Wilhelms—Universitat
Bonn, Germany, submitted by FMC Corp., Philadelphia, Pa.; CDL:091100-B)
00003743 Gorbach, S (1965) Investigations on Thiodan in the Metabolism of Milk Sheep.
Includes undated method. (Unpublished study including report, received Dec 7,
1967 under 7F0632; prepared by Farbwerke Hoechst AG, Germany, submitted by
FMC Corp., Philaphia, Pa.; CDL:091100-C)
00003744 Gorbach, S. (1973) Extraction of Endosulfan from Tea-Leaves. Includes method
dated Nov 4, 1973. (Unpublished study received on unknown date under
2H2667; prepared by Farbwerke Hoechst AG, Germany, submitted by American
Hoechst Corp., North Hollywood, Calif; CDL:225765-A)
00003760 Hinstridge, P. A. (1968) Project No. and Title: 015-Endosulfan and Endosulfan
Sulphate (Residues on Sweet Corn): R-l 111. (Unpublished study received Oct
17, 1969 under 9F0845; prepared in cooperation with Washington State Univ.,
Irrigated Agriculture Research and Extension Center, submitted by FMC Corp.,
Philadelphia, Pa.; CDL:091461-B)
00003777 Stanovick, R.P. (1964) Determination of Thiodan Residues on or in Cottonseed:
M-1339. Includes method dated Apr 3, 1964. (Unpublished study received Apr
9, 1964 under unknown admin, no.; submitted by FMC Corp., Philadelphia, Pa.;
CDL:119688-A)
00003778 Food Machinery and Chemical Corporation (1958) Analytical Method for
Determination of Thiodan Residues by Sulfur Dioxide Evolution. Method dated
Mar 11, 1958. (Unpublished study received Nov 25, 1958 under unknown admin.
no.;CDL:119664-A)
00003782 Stanovick, R.P. (1963) Determination of Thiodan Sulfate and Diol Residues on
Strawberries, Sweet Cherries and Tart Cherries Using the MCGC Analytical
Procedure: M-1246. (Unpublished study received Oct 8, 1968 under unknown
admin, no.; submitted by FMC Corp., Philadelphia, Pa.; CDL:119621-B)
154
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00003783 Stanovick, R.P. (1964) Determination of Thiodan I, II and Sulfate Residues on or
in Apples, Peaches, Pears, Cabbage and Tomatoes: M-1300. Includes method
dated March 19, 1964. (Unpublished study received Oct 8, 1968 under unknown
admin, no.; submitted by FMC Corp., Philadelphia, Pa.; CDL:119621-C)
00003784 Stanovick, R.P. (1965) Determination of Thiodan I, II and Sulfate Residues in or
on Peaches: M-1692. Includes method dated Dec 13, 1965. (Unpublished study
received Oct 8, 1968 under unknown admin, no.; submitted by FMC Corp.,
Philadelphia, Pa.; CDL: 119621-D)
00003785 Hinstridge, P. A. (1963) Project No. and Title: 15-Thiodan and Thiodan Sulphate
(Residues on Strawberries): R-666. (Unpublished study received Oct 8, 1968
under unknown admin, no.; submitted by FMC Corp., Philadelphia, Pa.;
CDL:119621-E)
00003786 Hinstridge, P. A. (1963) Project No. and Title: 15-Thiodan and Thiodan Sulphate
(Residues on Fresh and Dry French Prunes): R-673. (Unpublished study
received Oct 8, 1968 under unknown admin, no.; submitted by FMC Corp.,
Philadelphia, Pa.; CDL: 119621-F)
00003787 Hinstridge, P. A. (1963) Project No. and Title: 15-Thiodan and Thiodan Sulfate
Residues on Apples: R-677. (Unpublished study received Oct 8, 1968 under
unknown admin, no.; submitted by FMC Corp., Philadelphia, Pa.;
CDL:119621-G)
00003788 Hinstridge, P.A. (1963) Project No. and Title: 15-Thiodan and Thiodan Sulfate
Residues on Grapes: R-678. (Unpublished study received Oct 8, 1968 under
unknown admin, no.; submitted by FMC Corp., Philadelphia, Pa.;
CDL:119621-H)
00003789 Hinstridge, P.A. (1963) Project No. and Title: 15-Thiodan and Thiodan Sulfate
Residues on Peaches: R-689. (Unpublished study received Oct 8, 1968 under
unknown admin, no.; submitted by FMC Corp., Philadelphia, Pa.; CDL: 119621-1)
00003790 Hinstridge, P.A. (1963) Project No. and Title: 15-Thiodan and Thiodan Sulfate
Residues on Cabbage and Lettuce: R-698. (Unpublished study received Oct 8,
1968 under unknown admin, no.; submitted by FMC Corp., Philadelphia, Pa.;
CDL:119621-J)
155
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00003791 Hinstridge, P.A. (1964) Project No. and Title: 15-Thiodan (Residues on Fresh
French Prunes): R-783. (Unpublished study received Oct 8, 1968 under unknown
admin, no.; submitted by FMC Corp., Philadelphia, Pa.; CDL:119621-K)
00003795 Cassil, C.C.; Drummond, P.E. (1965) A plant surface oxidation product of
Endosulfan. Journal of Economic Entomology 58(2): 356-357.
(Also~In~unpublished submission received Apr 4, 1966 under 7F0526; submitted
by FMC Corp., Philadelphia, Pa.; CDL: 090630-A)
00003796 FMC Corporation (1965) Results of Tests of the Amount of Residues Remaining
and Description of Analytical Method: [Thiodan]. (pp. 4-213 only; unpublished
study received Apr 4, 1966 under 7F0526; CDL:090630-B)
00003797 Hinstridge, P.A. (1966) Project No. and Title: 015-Thiodan and Thiodan
Sulphate Residues on Fresh and Canned Pineapple: R-941. Includes undated
method. (Unpublished study received Apr 4, 1966 under 7F0526; submitted by
FMC Corp., Philadelphia, Pa.; CDL:090630-C)
00003798 Thornburg, W. (1966) Thiodan Residues on Treated Fresh Pineapple. Includes
method dated Feb 3, 1966. (Unpublished study received Apr 4, 1966 under
7F0526; prepared by California Packing Corp., submitted by FMC Corp.,
Philadelphia, Pa.; CDL:090630-D)
00003799 Thornburg, W. (1966) Thiodan Residues on Treated Canned Pineapple.
(Unpublished study received Apr 4, 1966 under 7F0526; prepared by California
Packing Corp., submitted by FMC Corp., Philadelphia, Pa.; CDL:090630-E)
00003823 Makhteshim Beer-Sheva Chemical Works, Limited (1969) Analytical
Method: Thionex: Technical Material and Formulations:
DS 15.35.10. (Unpublished study received Jun 19, 1972 under
11678-5; CDL:011014-C)
00003824 Makhteshim Chemical Works, Limited (1969) Analytical Method:
Thionex: Residue Analysis: DS 15.35.11. (Unpublished study re-
ceived Jun 19, 1972 under 11678-5; CDL:011014-D)
156
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00003825 Makhteshim Beer-Sheva Chemical Works, Limited (1969) Thionex: In-
secticide: Biological Data. (Unpublished study received Jun 19,
1972 under 11678-5; CDL:011014-E)
00003833 Howitt, AJ. (1969) Control of Pear Psylla on Pears: Michigan-1969
(4 Tests). (Unpublished study received Apr 13, 1970 under 279-
1182; prepared by Michigan State Univ., Dept. of Entomology,
submitted by FMC Corp., Philadelphia, Pa.; CDL:002302-E)
00003834 Hinstridge, P.A. (1964) Project No. and Title: 15-Thiodan Technical, Thiodan II
and Thiodan Sulfate Residues on Alfalfa: R-721. (Unpublished study received
Jul 14, 1967 under 8F0632; submitted by FMC Corp., Philadelphia, Pa.;
CDL:091099-C)
00003835 Hinstridge, P.A. (1965) Project No. and Title: 15-Thiodan and Thiodan Sulfate
(Residues on Alfalfa): R-859. (Unpublished study received Jul 14, 1967 under
8F0632; submitted by FMC Corp., Philadelphia, Pa.; CDL:091099-D)
00003836 Stanovick, R.P. (1964) Determination of Thiodan I, II and Sulfate Residues on or
in Alfalfa (Supplement to Report M-1403): M-1448. (Unpublished study
received Jul 14, 1967 under 8F0632; submitted by FMC Corp., Philadelphia, Pa.;
CDL:091099-F)
00003837 Palazzolo, R.J. (1966) Report to FMC Corporation, Niagara Chemical Division:
Milk and Meat Residue Study: Thiodan and Thiodan Sulfate: Cows: WCRF
Number 133. (Unpublished study received July 14, 1967 under 8F0632; prepared
by Industrial Bio-Test Laboratories, Inc., submitted by FMC Corp., Philadelphia,
Pa.; CDL:091099-H)
00003838 Stanovick, R.P. (1965) Determination of Thiodan I, II and Sulfate Residues in
Milk and Cow Tissues: M-1656. Includes method dated Oct 28, 1965.
(Unpublished study received Jul 14, 1967 under 8F0632; submitted by FMC
Corp., Philadelphia, Pa.; CDL:091099-I)
157
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00003840 Stanovick, R.P. (1967) Determination of Thiodan I, II and Sulfate Residues in
Eggs and Chicken Tissues: M-2142. Includes method dated May 1, 1967.
(Unpublished study received Jul 14, 1967 under 8F0632; submitted by FMC
Corp., Philadelphia, Pa.; CDL: 091099-L)
00003841 Ware, G.W. (1967) Studies of Pesticide Residues on Alfalfa Using
CA14=-Labeled Endosulfan, Wooster, Ohio: Ohio Agricultural Research and
Development Center. (Research circular 151; also In unpublished submission
received Jul 14, 1967 under 8F0632; submitted by FMC Corp., Philadelphia, Pa.;
CDL:091099-N)
00003843 FMC Corporation (1971) Recovery of Endosulfan I, II and Endosulfan Sulfate
from Blueberries: M-2908. (Unpublished study received Sep 17, 1971 under
1F1034; CDL:091919-B)
00003853 Lienk, S.E. (1964) Thiodan: Pear-Pear Psylla: M-1840. (Unpublished study
received Jul 18, 1972 under 279-1182; prepared in cooperation with Cornell
Univ., New York State Agricultural Experiment Station, submitted by FMC
Corp., Philadelphia, Pa.; CDL:002304-F)
00003854 Howitt, A.J. (1969) Thiodan: Pear-Pear Psylla: MC-364. (Unpublished study
received Jul 18, 1972 under 279-1182; prepared in cooperation with Michigan
State Univ., Dept. of Entomology, submitted by FMC Corp., Philadelphia, Pa.;
CDL: 0023 04-G)
00003859 Madsen, H.F. (1959) Thiodan: Pear-Pear Psylla: M-784. (Unpublished study
received Jul 18, 1972 under 279-1182; prepared in cooperation with Univ. of
California, submitted by FMC Corp., Philadelphia, Pa.; CDL:002304-Q)
00003860 Shuttleworth, J.M. (1970) Determination of Endosulfan and Endosul fan Sulfate
Residues in or on Pears: M-2627. Includes method dated Jun 16, 1970.
(Unpublished study received Jul 18, 1972 under 279-1182; submitted by FMC
Corp., Philadelphia, Pa.; CDL:002304-S)
00003861 Shuttleworth, J.M. (1971) Determination of Endosulfan I, Endosulfan II and
Endosulfan Sulfate Residues in or on Pears: M-2879. Includes method dated May
158
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
27, 1971. (Unpublished study received July 18, 1972 under 279-1182; submitted
by FMC Corp., Philadelphia, Pa.; CDL:002304-T)
00003862 Hinstridge, P.A. (1971) Project No. and Title: 015-Thiodan (Residues in or on
Pears): R-l 184. Includes undated method. (Unpublished study received Jul 18,
1972 under 279-1182; submitted by FMC Corp., Philadelphia, Pa.;
CDL:002304-U)
00003864 Hinstridge, P.A. (1966) Project No. and Title: 015-Thiodan and Thiodan
Sulphate Residues on Peppers: R-1001. (Unpublished study received Oct 17,
1966 under 279-1405; submitted by FMC Corp., Philadelphia, Pa.;
CDL:002394-A)
00003872 FMC Corporation (1960) Potatoes. (Unpublished study received March 1, 1961
under 279-1380; CDL:002350-C)
00003876 Madsen, H.F.; Bailey, J.B. (1958) Apple. (Unpublished study received Dec 26,
1961 under 279-1380; prepared by Univ. of California-Berkeley, submitted by
FMC Corp., Philadelphia, Pa.; CDL:002351-C)
00003885 Rathbone, K.M. (1966) Thiodan Tests on Grape Leaf Folder. (Unpublished study
received Feb 6, 1967 under 279-2548; submitted by FMC Corp., Philadelphia,
Pa.; CDL:002461-B)
00003898 Food Machinery and Chemical Corporation (1958) Summary of Pea Insect
Control with Niagara Thiodan Formulations. (Unpublished study received Sep
22, 1958 under 279-1182; prepared in cooperation with Univ. of Wisconsin;
CDL: 002283-A)
00003900 Jones, S.C. (1961) Western Cooperative Spray Project, January, 1961.
(Unpublished study including letter dated Feb 10, 1961 from S.C. Jones to Roger
G. Scott, received Apr 22, 1963 under 100-460; prepared by Oregon State
College, Experiment Station, Dept. of Entomology, submitted by Geigy
Agricultural Chemicals, Greensboro, N.C.; CDL:000353-B)
159
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00003906 FMC Corporation (1956) [Thiodan Field Performance Data: Alfalfa, Pears and
Potatoes]. (Unpublished study received Jan 24, 1957 under 279-1182;
CDL: 002279-A)
00003907 FMC Corporation (1963) [Thiodan Field Performance Data: Wheat, Barley and
Southern Field Peas]. (Unpublished study received Oct 9, 1964 under 279-1182;
CDL:008880-A)
00003908 FMC Corporation (1964) Ethion: Control of Apple and Pear Rust Mites.
(Unpublished study received Dec 28, 1964 under 279-1401; CDL:002382-A)
00003910 FMC Corporation (1964) Endosulfan (Thiodan): Blueberry Bud Mite Control.
(Unpublished study received Aug 25, 1964 under 279-1182; prepared in
cooperation with N. J. Blueberry Research Laboratory; CDL:008877-A)
00003916 Randolph, N.M. (1959) Progress Report 2083: Evaluation of Insecticides for the
Control of the Sorghum Webworm and the Corn Earworm on Grain Sorghum.
(Unpublished study received Aug 21, 1959 under unknown admin, no.; prepared
by Texas A & M Univ., Agricultural Experiment Station, Dept. of Entomology,
submitted by Union Carbide Corp., Agricultural Products, Washington, D.C.;
CDL:110532-F)
00003917 FMC Corporation (1965) Endosulfan and Endosulfan Sulfate Residues on Field
Peas (Shelled Peas and Pods): Study I. (Unpublished study received Jul 1, 1969
under 279-2659; CDL:002462-A)
00003918 FMC Corporation (1960) Pecan: M-832. (Unpublished study received Apr 24,
1961 under 279-1182; prepared in cooperation with Texas A & M Univ. and U.S.
Agricultural Research Service, Pecan Laboratory; CDL:002291-A)
00003919 FMC Corporation (1961) Pecans. (Unpublished study received Mar 26, 1962
under 279-1380; prepared in cooperation with U.S. Agricultural Research
Service, Pecan Laboratory, and Oklahoma State Univ. of Agriculture and Applied
Science and Texas A & M Univ.; CDL:002353-A)
160
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00003920 FMC Corporation (1965) Strawberry. (Unpublished study received Jan 10, 1966
under 279-1182; prepared in cooperation with Michigan State Univ. and New
York State Agricultural Experiment Station; CDL:008885-A)
00003924 FMC Corporation (1969) Cabbage. (Unpublished study received Jan 24, 1969
under 279-1380; prepared in cooperation with Everglades Experiment Station;
CDL:002374-A)
00003938 Schread, J.C. (1966) Pests of Ornamentals: Reports on Control Experiments: The
Black Vine Weevil. Rev. New Haven: Univ. of Connecticut, (pp. 7-8 only;
Agricultural Experiment Station, Circular 211; also~In~unpublished submission
received Apr 7, 1966 under 279-1380; submitted by FMC Corp., Philadelphia,
Pa.; CDL:002366-A)
00003947 FMC Corporation (1965) Potato. (Unpublished study received Jan 27, 1967
under 279-2032; CDL:028276-B)
00003948 Moore, D.H. (1966) Project Number and Title: 060 Polyram-Aerial Application
of Polyram to Potatoes: M-2023. (Unpublished study received Jan 27, 1967
under 279-2032; submitted by FMC Corp., Philadelphia, Pa.; CDL:028276-C)
00003949 FMC Corporation (1965) Endosulfan and Endosulfan Sulfate Residues on Field
Peas (Shelled Peas and Pods). (Unpublished study received Jul 1, 1969 under
279-1182; CDL:022704-A)
00003950 Ruppel, R.F. (1964) Oats. (Unpublished study received Oct 25, 1965 under
279-1182; prepared by Michigan State Univ., Dept. of Entomology, submitted by
FMC Corp., Philadelphia, Pa.; CDL: 008884-B)
00003952 FMC Corporation (1960) Thiodan Recovery Data. (Unpublished study received
Aug24, 1960 under 279-1381; CDL:101258-A)
00003956 Stauffer Chemical Company (1958) [Trials of Various Pesticides for Control of
Peach Twig Borer Larvae: California, 1958.] (Unpublished study received Feb
12, 1965 under 476-1088; CDL:221340-A)
161
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00003959 FMC Corporation (19??) Results of Tests of the Amount of Residues Remaining
and Description of Analytical Methods: (Thiodan). (Unpublished study received
Jun 21, 1966 under 7F0526; CDL: 095429-A)
00003960 FMC Corporation (19??) Name, Chemical Identity and Composition of Pesticide
Chemical: (Thiodan). (Unpublished study received Jun 21, 1966 under 7F0526;
CDL:095429-C)
00004254 FMC Corporation (1967) Results of Tests of the Amount of Residues Remaining
and Description of Analytical Method: [Endosulfan]. (Unpublished study
received May 29, 1970 under OF0922; CDL: 091576-A)
00004255 FMC Corporation (19??) Practicable Methods of Removing Residues That
Exceed Proposed Tolerance: [Thiodan]. (Unpublished study received Dec 16,
1959 under PP0237; CDL:092514-D)
00004256 U.S. National Cancer Institute (1978) Bioassay of Endosulfan for Possible
Carcinogenicity. By Division of Cancer Cause and Pre vention, Carcinogenesis
Testing Program. Bethesda, Md.: U.S. Dept. of Health, Education, and Welfare.
(DHEW publication no. (NIH) 78-1312; also~In~unpublished submission
received Jul 26, 1978 under 4E1430; submitted by American Hoechst Corp.,
Somerville, N.J.; CDL:097264-A)
00004257 Deema, P.; Thompson, E.; Ware, G.W. (1966) Metabolism, storage, and excretion
of C14-Endosulfan in the mouse. Journal of Economic Entomology
59(3):546-550. (Also in unpublished submission received Jul 14, 1967 under
8F0632; submitted by FMC Corp., Philadelphia, Pa.; CDL:091099-A)
00004258 Stanovick, R.P. (1964) Determination of Thiodan I, II and Sulfate Residues on or
in Alfalfa, Red Clover and Bird's-Foot Trefoil: M-1403. Includes undated
method. (Unpublished study received Jul 14, 1967 under 8F0632; submitted by
FMC Corp., Philadelphia, Pa.; CDL:091099-E)
00022923
Hilletal. /1975
162
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00038306 Buccafusco, RJ. (1976) Acute Toxicity of Endosulfan Technico to Bluegill
(|l~Lepomis macrochirus~|l). (Unpublished study received Jul 28, 1980 under
2749-487; prepared by EG&G, Bionomics, submitted by Aceto Chemical Co.,
Inc., Flushing, N.Y.; CDL:243084-A)
00038307 Reno, F.E. (1975) Final Report: Acute Oral Toxicity Study in Rats: Project No.
915-108. (Unpublished study received Jul 28, 1980 under 2749-487; prepared by
Hazleton Laboratories America, Inc., submitted by Aceto Chemical Co., Inc.,
Flushing, N.Y.; CDL: 243082-A)
00038308 Reno, F.E. (1976) Final Report: Acute Dermal Toxicity Study in Rabbits: Project
No. 915-109. (Unpublished study received July 28, 1980 under 2749-487;
prepared by Hazleton Laboratories America, Inc., submitted by Aceto Chemical
Co., Inc., Flushing, N.Y.; CDL:243082-B)
00038309 Reno, F.E. (1975) Final Report: Primary Skin Irritation Study in Rabbits: Project
No. 915-111. (Unpublished study received Jul 28, 1980 under 2749-487;
prepared by Hazleton Laboratories America, Inc., submitted by Aceto Chemical
Co., Inc., Flushing, N.Y.; CDL: 243082-C)
00094837 MacKenzie, K.M.; Felton, S.M.; Dickie, S.M.; et al. (1981) Teratology Study
with FMC 5462 in Rabbits: Raltech Study No. 80070; FMC Study # A79-370
00128645 Crown, S.; Nyska, A. (1982) Thionex 50WP: Acute Oral Toxicity in the Rat:
LSRI Report No. MAK/024/TNX 50WP. Final rept. (Unpublished study
received May 31, 1983 under 11678-42; prepared by Life Science Research Israel
Ltd., submitted by Makhteshim Beer-Sheva Chemical Works Ltd., New York,
NY; CDL:250399-A)
00128646 Crown, S.; Hovevey-Sion, D.; Nyska, A. (1982) Thionex 50 WP: Acute Dermal
Toxicity in Rabbits: LSRI Report No. MAK/025/TNX 50 WP. Final rept.
(Unpublished study received May 31, 1983 under 11678-42; prepared by Life
Science Research Israel Ltd., submitted by Makhteshim Beer-Sheva Chemical
Works Ltd., New York, NY; CDL:250399-B)
163
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00128647 Buch, S.; Gardner, 1; Bannerman, M.; et al. (1983) Thionex 50 WP: Inhalation
Toxicity in the Rat: LSR Report No. 83/MAK048/037. (Unpublished study
received May 31, 1983 under 11678-42; prepared by Life Science Research, Eng.,
submitted by Makhteshim Beer-Sheva Chemical Works Ltd., New York, NY;
CDL:250399-C)
00128648 Crown, S.; Nissimov, S. (1982) Thionex 50 WP: Primary Eye Irritation Study in
the Rabbit: LSRI Report No. MAK/027/TNX/50WP. Final rept. (Unpublished
study received May 31, 1983 under 11678-42; prepared by Life Science Research
Israel Ltd., submitted by Makhteshim Beer-Sheva Chemical Works Ltd., New
York, NY; CDL:250399-D)
00128649 Crown, S.; Hamami, S. (1982) Thionex 50 WP: Primary Dermal Irritation Study
in Rabbits: LSRI Report No. MAK/026/TNX 50 WP. Final report. (Unpublished
study received May 31, 1983 under 11678-42; prepared by Life Science Research
Israel Ltd., submitted by Makhteshim Beer-Sheva Chemical Works Ltd., New
York,NY;CDL: 250399-E)
00128650 Makhteshim Beer-Sheva Chemical Works Ltd. (1983) Thionex 35 EC: End Use
Product: [Chemistry Data]. (Compilation; unpublished study received May 31,
1983 under 11678-25; CDL:250400-A)
00128655 Kintner, D.; Forbis, A. (1983) Acute Toxicity of Thionex 3 EC to Rainbow Trout
...: Static Bioassay Report #29975. (Unpublished study received May 31, 1983
under 11678-25; prepared by Analytical Bio-Chemistry Laboratories, Inc.,
submitted by Makhteshim Beer-Sheva Chemical Works, Ltd., New York, NY;
CDL:250401-A)
00128656 Kintner, D.; Forbis, A. (1983) Acute Toxicity of Thionex 3 EC to Bluegill
Sunfish ...: Static Bioassay Report #29974. (Unpublished study received May 31,
1983 under 11678-25; prepared by Analytical Bio-Chemistry Laboratories, Inc.,
submitted by Makhteshim Beer-Sheva Chemical Works, Ltd., New York, NY;
CDL:250401-B)
00128657 American Hoechst Corp. (1982) [Chemistry of Thiodan]. (Compilation;
unpublished study received May 31, 1983 under 8340-13; CDL:250395-A)
164
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00128658 Energy Resources Co., Inc. (1983) Acute Toxicity of Endosulfan to Embryos of
the Eastern Oyster (Crassostrea virginica) and the Fiddler Crab (Uca pugnax).
Final rept. (Unpublished study received May 31, 1983 under 8340-13; submitted
by American Hoechst Corp., Somerville, NJ; CDL:250395-B)
00128659 Gorlitz, G.; Klockner, C. (1982) Hydrolysis of Hoe 02671 (Endosulfan): Bericht
Nr. (B) 90/82; A25677. (Translation of document no. A 24433; unpublished
study received May 31, 1983 under 8340-13; prepared by Hoechst AG, W. Ger.,
submitted by American Hoechst Corp., Somerville, NJ; CDL:250395-C)
00128660 Gildemeister, H.; Jordan, H. (1983) Photolytic Degradation of the Insecticide
Endosulfan on Soil Covered Thin Layer Plates under Simulated Sunlight: Bericht
Nr. (B)46/83; A25805. (Unpublished study received May 31, 1983 under
8340-13; prepared by Hoechst, AG, W. Ger., submitted by American Hoechst
Corp., Somerville, NJ; CDL:250395-D)
00128661 Makhteshim Beer-Sheva Chemical Works, Ltd. (19??) Endosulfan Technical.
(Compilation; unpublished study received May 31, 1983 under 11678-5;
CDL:250396-A)
00128662 Makhteshim Beer-Sheva Chemical Works, Ltd. (1983) [Chemistry of Thionex
(Endosulfan) Technical]. (Compilation; unpublished study received May 31,
1983 under 11678-5; CDL:250397-A)
00128663 Makhteshim Beer-Sheva Chemical Works, Ltd. (1983) Endosulfan Registration
Standard—End Use Product—Thionex (Endosulfan) 50 W. (Compilation;
unpublished study received May 31, 1983 under 11678-42; CDL:250398-A)
00128688 Boeri, R. H. And T. J. Ward. 1983. Acute toxi city of Endosulfan to embryos of
the eastern oyster (Crassostrea virginica) and the fiddler crab (Ucapugnax).
Energy Resources Co., Inc. Cambridge, MA (Access Number 128688)
00128846 FMC Corp. (1983) [Chemistry: Thiodan 50 WP Code 190]. (Compilation;
unpublished study received Jun 1, 1983 under 279-1380; CDL:250423-A)
165
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00128847 DeProspo, 1; Freeman, C.; Barbera, 1; et al. (1983) Acute Oral Toxicity of
Thiodan 50 WP in Rats: Study No. A82-793. (Unpublished study received Jun 1,
1983 under 279-1380; submitted by FMC Corp., Philadelphia, PA;
CDL:250424-A)
00128848 DeProspo, 1; Freeman, C.; Barbera, 1; et al. (1983) Acute Dermal Toxicity
Screen in Rabbits Using Thiodan 50 WP: Study No. A82-794. (Unpublished
study received Jun 1, 1983 under 279-1380; submitted by FMC Corp.,
Philadelphia, PA; CDL:250242-B)
00128849 Maedgen, 1; Cannelongo, B.; Sabol, R.; et al. (1983) Rat Acute Inhalation
Toxicity: Project No. 2879-83; FMC Study No. A82-797. (Unpublished study
received Jun 1, 1983 under 279-1380; prepared by Stillmeadow, Inc., submitted
by FMC Corp., Philadelphia, PA; CDL:250424-C)
00128850 DeProspo, J.; Norvell, M.; Freeman, C.; et al. (1983) Primary Eye Irritation Study
in Rabbits Using Thiodan 50 WP: Study No. A82-796. (Unpublished study
received Jun 1, 1983 under 279-1380; submitted by FMC Corp., Philadelphia,
PA; CDL:250424-D)
00128851 DeProspo, J.; Norvell, M.; Freeman, C.; et al. (1983) Primary Skin Irritation
Study in Rabbits Using Thiodan 50 WP: Study No. A82-795. (Unpublished study
received Jun 1, 1983 under 279-1380; submitted by FMC Corp., Philadelphia,
PA; CDL:250424-E)
00129215 Velsicol Chemical Corp. (1977) [Chemistry: Endosulfan]. (Compilation;
unpublished study received Jul 14, 1983 under 876-201; CDL: 250726-A)
00129216 Velsicol Chemical Corp. (1977) Product Chemistry Information: Tiovel 50 WP
Insecticide]. (Compilation; unpublished study received Jul 14, 1983 under
876-202; CDL:250727-A)
00129217 Bier, C.; Guitar, D.; Procter, B. (1981) Acute Dermal Toxicity in Albino Rabbits
Administered Test Article Tiovel 50 WP: Project No. 12884. (Unpublished study
received Jul 14, 1983 under 876-202; prepared by Bio-Research Laboratories
Ltd., submitted by Velsicol Chemical Corp., Chicago, IL; CDL:250727-E)
166
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00129673 US EPA (1981) Administrative Record of the Registration Standard for
Hexachlorohexahydromethano-2,4,3-benzodioxathiepin 3-Oxide (Endosulfan)
00133027 DeProspo, I; Freeman, C. (1983) Acute Oral Toxicity Study of Thiodan 3EC in
Rats: FMC Reference A83-1046. (Unpublished study received Dec 20, 1983
under 279-2924; submitted by FMC Corp., Philadelphia, PA; CDL:252013-A)
00134388 FMC Corp. (1973) Studies of the Impact of Endosulfan on the Environment.
(Compilation; unpublished study received Nov 1, 1973 under unknown admin.
no.;CDL:120346-A)
00134389 FMC Corp. (1973) [Environmental Chemistry of Endosulfan]. (Compilation;
unpublished study received Nov 1, 1973 under unknown admin, no.;
CDL:120346-B)
00134390 Schumachar, G.; Klein, W.; Korte, F. (1971) Photochemische reaktionen des
endosulfans in losung. Tetrahedron Letters (24):2229-2232. (Also In
unpublished submission received Nov 1, 1973 under unknown admin, no.;
submitted by FMC Corp., Philadelphia, PA; CDL:120346-E)
00134391 Archer, T. (1973) Endosulfan residues on alfalfa hay exposed to drying by
sunlight, ultraviolet light and air. Pestic. Sci. 4:59-68. (Also In unpublished
submission received Nov 1, 1973 under unknown admin, no.; submitted by FMC
Corp., Philadelphia,?A; CDL:120346-G)
00134392 Wendler, S.; Harnish, W.; Krog, N. (1972) In vitro Bioassay Report: Fungicide
Laboratory: [Thiodan Insecticide]: Project No. 016. (Unpublished study received
Nov 1, 1973 under unknown admin.no.; submitted by FMC Corp., Philadelphia,
PA;CDL:120346-H)
00134393 Oeser, H.; Gorbach, S.; Knauf, W. (1971) Endosulfane and the environment.
Pages 17-22, In [Source unknown]. (May; also In unpublished submission
received Nov 1, 1973 under unknown admin, no.; submitted by FMC Corp.,
Philadelphia, PA; CDL: 120346-1)
167
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00134394 Knauf, W.; Schulze, E. (1973) New Findings on the Toxicity of Endosulfan and
Its Metabolites to Aquatic Organisms. (Unpublished study received Nov 1, 1973
under unknown admin, no.; prepared by Farbwerke Hoechst AG, W. Ger.,
submitted by FMC Corp., Philadelphia, PA; CDL:120346-J)
00134395 Greve, P. (1970) The Persistence of Endosulfan in Surface Water. A translation
of: De Persistentie van Endosulfan in Oppervlaktewater. (Presented at the 22nd
International Symposium of Phytopharmacy and Phytoiatrics; May 5, 1970,
Ghent, Belg.; unpublished study received Nov 1, 1973 under unknown admin.
no.; submitted by FMC Corp., Philadelphia, PA; CDL:120346-L)
00134396 Eichelberger, J.; Lichtenberg, J. (1971) Persistence of pesticides in river water.
Environmental Science & Technology 5(6):541-544. (Also In unpublished
submission received Nov 1, 1973 under unknown admin.no.; submitted by FMC
Corp., Philadelphia, PA; CDL:120346-M)
00136994 Jung; Weigand (1983) Hoe 002671--Active Ingredient Technical (Code: Hoe
002671 01ZD97 0003): Test for Sensitizing Properties in Female Pirbright-White
Guinea Pigs According to the Method of Buehler: Report No. 83.0339.
(Translation; unpublished study received Dec 27, 1983 under 8340-13; prepared
by Hoechst AG, West Germany, submitted by American Hoechst Corp.,
Somerville, NJ; CDL: 252043-A)
00136995 Huntingdon Research Centre (1983) Endosulfan—Toxicity to Rats in Dietary
Administration over 13 Weeks. (Protocol; unpublished study received Dec 27,
1983 under 8340-13; submitted by American Hoechst Corp., Somerville, NJ;
CDL:252043-C)
00136996 Huntingdon Research Centre (1983) Endosulfan—Toxicity to Mice in Dietary
Administration over 13 Weeks. (Protocol; unpublished study received Dec 27,
1983 under 8340-13; submitted by American Hoechst Corp., Somerville, NJ;
CDL:252043-D)
00136997 Roberts, N.; Phillips, C. (1983) The Acute Oral Toxicity (LD50) of
Endosulfan-Technical (Code: HOE 002671 OIZD97 0003) to the Bobwhite
Quail: HST 224/83566. (Unpublished study received Dec 27, 1983 under
168
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
8340-13; prepared by Huntingdon Researh Centre, Eng., submitted by American
Hoeschst Corp., Somerville, NJ; CDL: 252043-E)
00136998 Roberts, N.; Phillips, C. (1983) The Acute Oral Toxicity (LD50) of
Endosulfan-Technical (Code: HOE 002671 OIZD97 0003) to the Mallard Duck:
HST 226/83493. (Unpublished study received Dec 27, 1983 under 8340-13;
prepared by Huntingdon Research Centre, Eng., submitted by American Hoeschst
Corp., Somerville, NJ; CDL: 252043-F)
00136999 Fischer, R. (1983) The Effect of Hoe 002671 OI ZD96 0002 (Endosulfan, Active
Ingredient 95.9%) on Salmo gairdneri (Rainbow Trout) in a Static Test:
OEK83/019E; Document #A26006. (Unpublished study received Dec 27, 1983
under 8340-13; prepared by Hoechst AG, West Germany, submitted by American
Hoeschst Corp., Somerville, NJ; CDL:252043-G)
00137000 Huntingdon Research Centre (1983) To Study the Effect of Endosulfan on Avian
Reproduction in the Bobwhite Quail. (Protocol; unpublished study received Dec
27, 1983 under 8340-13; submitted by American Hoechst Corp., Somerville, NJ;
CDL:252043-H)
00137001 Huntingdon Research Centre (1983) To Study the Effect of Endosulfan on Avian
Reproduction in the Mallard Duck. (Protocol; unpublished study received Dec
27, 1983 under 8340-13; submitted by American Hoechst Corp., Somerville, NJ;
CDL:252043-I)
00137002 Gildemeister, H.; Remmert, U. (1983) Leaching Study of the Insecticide Hoe
002671 and Its Degradates: Bericht Number (B) 135/83; A27287. (Unpublished
study received Dec 27, 1983 under 8340-13; prepared by Hoechst AG, W. Ger.,
submitted by American Hoechst Corp., Somerville, NJ; CDL:252043-J)
00137003 Gildemeister, H. (1983) Terrestrial Field Dissipation Studies with the Insecticide
Endosulfan: Bericht Number (B) 124/83; A27207. (Unpublished study received
Dec 27, 1983 under 8340-13; prepared by Hoechst AG, W. Ger., submitted by
American Hoechst Corp., Somerville, NJ; CDL:252043-L)
169
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00137161 Gildemeister, H. (1983) Terrestrial Field Dissipation Studies with the Insecticide
Endosulfan: BerichtNr. (B) 124/83; A27207. (Unpublished study received Jan
12, 1984 under 11678-5; prepared by Hoechst AG, W. Ger., submitted by
Makhteshim Beer Sheva Chemical Works, Ltd., New York, NY; CDL:252184-A)
00137162 Gildemeister, H.; Remmert, U. (1983) Leaching Study of the Insecticide Hoe
002671 and Its Degradates: BerichtNr. (B) 135/83; A27287. (Unpublished study
received Jan 12, 1984 under 11678-5; prepared by Hoechst AG, W. Ger.,
submitted by Makhteshim Beer Sheva Chemical Works, Ltd., New York, NY;
CDL:252185-A)
00137189 Roberts, N.; Phillips, C. (1983) The Acute Oral Toxicity (LD50) of Endosulfan
Technical (Code: Hoe 002671 OIZD97 0003) to the Bobwhite Quail: HST
224/83566; A27035. (Unpublished study received Jan 16, 1984 under 11678-5;
prepared by Huntingdon Research Centre, Eng., submitted by Makhteshim Beer
Sheva Chemical Works, Ltd., New York, NY; CDL:252229-A)
00137446 Gorlitz, G.; Klockner, C. (1982) Hoe 002671, Adsorption/Desorption in the
Soil/Water System: Bericht Number (B) 125/82; A27021. (Translation;
unpublished study received DEc 27, 1983 under 8340-13; prepared by Hoechst
AG, W. Ger., submitted by American Hoechst Corp., Somerville, NJ;
CDL:252043-K)
00138256 Interregional Research Project No. 4 (1976) Results of Tests Concerning the
Amount of Residues of Endosulfan and Its Metabolite, Endosulfan Sulfate
Remaining in or on Raspberries, Including a Description of the Analytical
Method Used. (Compilation; unpublished study received Mar 23, 1977 under
7E1940; CDL:072500-A)
00139081 Hooker Chemical & Plastics Corp. (1976) [Chemistry of Endosulfan].
(Compilation; unpublished study received Mar 6, 1984 under 935-26;
CDL:252567-A)
00139644 FMC Corp. (1964) Thiodan: Residue Data on Sugarcane: Ref. M-1264.
(Unpublished study received Mar 6, 1964 under 279-4; CDL:109896-A)
170
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
GS014024 Gunther, F.A. et. al. (1951) Sulfur Dioxide Evolution Method. Analytical
Chemistry, 23:1835
00142640 Dorr, V. (1984) Letter sent to G. LaRocca dated May 25, 1984: Thiodan
Technical (Endosulfan) EPA Registration Number 8340-13 partial response to
EPA letter of January 9, 1984. 8 p.
00142649 Bearden, C. (1967) Field Test Concerning the Effects of "Dibrom 14
Concentrate" (Naled) on Estuarine Animals. Contribution No. 45. Wadmalow
Island, SC: Bears Bluff Laboratories. 13 p.
00142768 Buch, S. (1983) Thionex 35 EC: Acute Inhalation Toxicity in the Rat: LSR Rept.
No: 83/MAK049/036. Unpublished study prepared by Life Science Research. 73
P-
00142769 Buch, S. (1983) Thionex 50 WP: Acute Inhalation Toxicity in the Rat: LSR Rept.
No: 83/MAK048/037. Unpublished study prepared by Life Science Research. 79
P-
00142850 Collins, W. (1983) Letter sent to J. Alden dated June 3, 1983: Raw data from
range finding study with thiodan sprayo. Prepared by Springborn Institute for
Bioresearch, Inc. 10 p.
00145668 Barnard, A.; Jones, D.; Powell, L.; et al. (1985) 13 Week Toxicity Study In Rats
Followed by a 4-Week Withdrawal Period: Endosulfan, Includes
Histopathological Review. Final Report: Report No. HST 230/84176.
Unpublished study prepared by Huntingdon Research Centre PIC. 508 p.
00146841 Ebert (1985) Endosulfan—Active Ingredient Technical: Testing for Subchronic
Dermal Toxicity (21 Applications over 30 Days) in Wistar Rats: Report No.
84.0223. Unpublished study prepared by Hoechst AG. 455 p.
00146842 American Hoechst Corp. (1985) Reregi strati on for Tolerances of Endosulfan
Residues in Tomatoes and Cucurbits: Analytical Methods and Residue Data.
Unpublished compilation. 453 p.
171
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00146843 Roberts, N.; Phillips, C.; Dawe, I; et al. (1985) The Effects of Dietary Inclusion
of Endosulfan—Technical on Reproduction in the Mallard Duck. HRC Report
No. HST 228b/841012. Unpublished study prepared by Huntington Research
Centre pic. 211 p.
00146844 Gildemeister, H. (1985) Anaerobic Soil Metabolism Study with the Insecticide
Endosulfan: Hoe 002671-14-C: Report No. (B)91/85. Unpublished study
prepared by Hoechst AG. 24 p.
00146997 Hinstridge, P. (1968) Thiodan and Thiodan Sulphate (Residues on Fresh
Pineapple and Pineapple Bran): Project No. 15;R-1097. Unpublished study
prepared by FMC Corp. 13 p.
00147180 Carmines, E. (1985) Evaluation of the Toxicity Data on Endosulfan: 1984:
Summary. Unpublished study prepared by American Hoechst Corp. 10 p.
00147181 Roberts, N.; Phillips, C.; Gopinath, C. (1983) Acute Delayed Neurotoxicity Study
with Endosulfan-Technical in the Domestic Hen: Report No. HST 225/83888.
Unpublished study prepared by Huntingdon Research Centre pic. 46 p.
00147182 Barnard, A.; Atkinson, 1; Heywood, R.; et al. (1984) Endosulfan-Active
Ingredient Technical: 13-Weeks Toxicity Study in Mice: Final Report: Report
No. HST 229/831052. Unpublished study prepared by Huntingdon Research
Centre pic. 379 p.
00147183 Hollander; Weigand; Kramer (1984) Endosulfan--Active Ingredient Technical:
Testing for Subchronic Inhalation Toxicity—21 Exposures in 29 Days—in SPF
Rats: Report No. 84.0539. Unpublished study prepared by Hoechst AG. 559 p.
00147196 Edwards, I; Hughes, E.; Almond, R. (1982) Preliminary Investigation of
Endosulfan on Reproduction of the Rat: Report No. HST 203/82253. Unpublished
study prepared by Huntingdon Research Centre. 76 p.
00147197 Jung, Weigand, Kramer (1983) Hoe 002671-Active Ingredient Technical:
Micronucleus Test in Male and Female NMRI Mice Following Oral
172
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
Administration: Report No. 83.0458. Unpublished study prepared by Hoechst
AG. 13 p.
00147198 Milone, M. (1984) Study of the Mutagenic Activity of the Compound
Endosulfan—Technical with Sacchromyces cerevisiae: Gene Conversion—DNA
Repair Test: Experiment No. M 707. Unpublished study prepared by Istituto Di
Ricerche Biomediche "Antoine Marxer" S.p.A. 19 p.
00147199 Milone, M. (1984) Study of the Mutagenic Activity "in vitro" of the Compound
Endosulfan—Technical With Schizosacchromyces pombe: Experiment No. M
708. Unpublished study prepared by Istituto Di Ricerche Biomediche "Antoine
Marxer" S.p.A. 17 p.
00147299 Leist; Kramer (1985) 30-Day Feeding Study in Adult Male Wistar Rats:
Endosulfan—Active Ingredient Technical: Study No. 84. 0585: Report No.
A30776. Unpublished study prepared by Hoechst AG. 249 p.
00147744 Ebert (1985) Endosulfan—Active Ingredient Technical: Testing for Subchronic
Dermal Toxicity (21 Applications over 30 Days) in Wistar-Rats: Report No.
84.0321. Unpublished study prepared by Hoechst AG. 558 p.
00148264 Edwards, I; Reid, Y.; Offer, I; et al. (1984) Effect of Endosulfan-Technical on
Reproductive Function of Multiple Generations of the Rat: Report No. HST
204/83768. Unpublished study prepared by Huntingdon Research Centre pic.
422 p.
00148265 Cifone, M. (1984) Evaluation of Hoe 002671-Substance Technical in the Rat
Primary Hepatocyte Unscheduled DNA Synthesis Assay: Final Report: Project
No. 20991. Unpublished study prepared by Litton Bionetics, Inc. 15 p.
00148266 Cifone, M. (1984) Mutagenicity Evaluation of Hoe 002671-Substance Technical
in the Mouse Lymphoma Forward Mutation Assay: Final Report: Project No.
20989. Unpublished study prepared by Litton Bionetics, Inc. 19 p.
173
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00148833 Turner, W.; Khalifa, S.; Casida, J. (1975) Toxaphene toxicant A. Mixture of
2,2,5-endo,6-exo,8,8,9,10-octachlorobornaneand,2,5-endo,6-exo,8,9,9,
10-octachlorobornane. J. Agric. Food Chem. 23(5):991-994.
00148992 Roberts, N.; Phillips, C.; Almond, R; et al. (1984) The Effects of Dietary
Inclusion of Endosulfan-Technical (Code: Hoe 002671 OI ZD97 0003) on
Reproduction in the Bobwhite Quail: HRC Report No. HST 227/84362.
Unpublished study prepared by Huntingdon Research Centre pic. 285 p.
00148993 Gildemeister, H.; Jordan, H. (1984) Aerobic Soil Metabolism Study of the
Insecticide Hoe 002671 (Endosulfan): Project No. OE-134/04.02: Report No.
(B) 176/84. Unpublished study prepared by Hoechst AG. 24 p.
00150714 Dorr, V. (1985) Letter sent to G. LaRocca, dated Jan. 9, 1985: Thiodan Technical
(Endosulfan). Prepared by American Hoechst Corp. 2 p.
00151253 Todd, F.; Reed, C. (1969) Pollen gathering of honey bees reduced by pesticide
sprays. Journal of Economic Entomology 62(4):865-867.
00151254 Miles, J.; Sans, W.; Wressell, H.; et al. (1964) Growth-dilution as a factor in the
decline of pesticide residues on alfalfagrass forage. Canadian Journal of Plant
Science 44(1):37-41.
00151761 Lightowler, J. (1984) Thionex 35 : Acute Oral Toxicity Study in Rats: LSR
Report No : 78/MAK2/432. Unpublished study prepared by Life Science
Research. 14 p.
00151762 Lightowler, J.; Gardner, J. (1984) Thionex 35 : Acute Percutaneous Toxicity in
Rats: LSR Report No. 78/MAK3/437. Unpublished report prepared by Life
Sciences Research. 14 p.
00151763 Crown, S. (1982) Thionex 35EC Primary Eye Irritation Study in the Rabbit: LSRI
Report No. MAK/030/TNX 35EC. Unpublished report prepared by Life
Research Israel Ltd. 20 p.
174
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00151764 Crown, S.; Nissimov, S. (1982) Thionex 35 EC Primary Dermal Irritation Study
in Rabbits: LSRI Report No. MAK/029/TNX 35 EC. Unpublished report
prepared by Life Science Research Israel Ltd. 12 p.
00156259 FMC Corp. Agricultural Chemical Group (1984) Thiodan Insecticide: Endosulfan
Reregi strati on Residue Chemistry: Apple Pomace, Artichokes, Celery, Cherries,
Grape and Raisin Waste, Lettuce, Pineapple Bran. Unpublished compilation. 213
P-
00157147 Rohrbach, K.; Namba, R.; Hylin, I; et al. (1985) Analysis of Processed Pineapple
Products for Residues of Endosulfan: Project No. G237. Unpublished study
prepared by University of Hawaii, College of Tropical Agriculture and Human
Resources, Department of Agricultural Biochemistry. 38 p.
00157148 Rose, S.; Grigor, A. (1986) Analysis of Thiodan (Endosulfan) in Alfalfa Seeds
and Screenings: Study No. 85057. Unpublished study prepared by Tegeris
Laboratories, Inc. 25 p.
00157522 Rosenfeld, G. (1985) Primary Dermal Irritation Study in Rabbits: Test Article:
Endosulfan 3 E.G.: Study #1235E. Unpublished study prepared by Cosmopolitan
S afety Evaluati on, Inc. 16 p.
00157608 Schulz, M. (1985) Acute Dermal Toxicity Study in Rabbits of Endosulfan 50 WP:
Project No. LAN-AT-008. Unpublished study prepared by Intox Laboaratories.
54 p.
00157609 Schulz, M. (1985) Guinea Pig Maximization Test Using Endosulfan 50 WP:
Project No. LAN-AT-009. Unpublished study prepared by Intox Laboratories.
16 p.
00157610 Schulz, M. (1985) Acute Oral Toxicity Study in Rats of Endosulfan 50 WP:
Project No. LAN-AT-010. Unpublished study prepared by Intox Laboratories.
143 p.
00157612 Frith, C. (1985) Primary Dermal Irritation Study of Endosulfan 50 WP: Project
No. LAN-AT-004. Unpublished study prepared by Intox Laboratories. 16 p.
175
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
00157696 Rosenfeld, G. (1985) Primary Eye Irritation Study in Rabbits: Endosulfan 3 B.C.:
Study #1235D. Unpublished study prepared by Cosmopolitan Safety Evaluation,
Inc. 24 p.
00160095 Tucker, D., comp. (1986) Product Chemistry: SA-50 Brand Thiodan 4 Dust.
Unpublished compilation. 45 p.
00160325 Brandt, J. (1982) The residual toxicity of field-weathered insecticide residues on
citrus leaves during spring to a parasite of red scale. Citrus Subtrop. Fit. Jour.
587:16-19,21.
00160333 Koshy, G.;Das, N.; Nair, M. (1972) Deterioration of insecticides on glass and on
leaf surface. Agr. Res. J. Kerala 10(2): 128-132.
00163127 American Hoechst Corp. (1986) Endosulfan - Estimation of the Expected
Environmental Concentration (EEC) ...- [Residues in Plants]. Unpublished
compilation. 522 p.
00163839 Buch, S.; Gardner, J. (1983) Thionex 35 EC: Acute Inhalation Toxicity in the Rat:
LSR Report No. 83/MAK049/036: Schedule No. MAK/031. Unpublished study
prepared by Life Science Research. 79 p.
00165055 Roberts, N. (1983) Protocol from Huntingdon Research Centre: Acute Delayed
Neurotoxicity of Endosulfan to the Domestic Hen". Unpublished study prepared
by Huntingdon Research Centre. 10 p.
05000837 Johansen, C.A. (1972) Toxicity of field-weathered insecticide residues to four
kinds of bees. Environmental Entomology l(3):393-394.
05001663 Benson, W.R. (1969) The chemistry of pesticides. Annals of the New York
Academy of Sciences 160(l):7-29.
176
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
05001721 Siek, T.J.; Osiewicz, R.J.; Bath, RJ. (1976) Identification of drugs and other toxic
compounds from their ultraviolet spectra Part III: ultraviolet absorption properties
of 22 structural groups. Journal of Forensic Sciences 21(3):525-551.
05002183 Boyd, E.M.; Dobos, I; Krijnen, C.J. (1970) Endosulfan toxicity and dietary
protein. Archives of Environmental Health 21(1): 15-19.
05002565 Beard, I.E.; Ware, G.W. (1969) Fate of endosulfan on plants and glass. Journal of
Agricultural and Food Chemistry 17(2):216-220.
05002841 Archer, I.E.; Nazer, I.K.; Crosby, D.G. (1972) Photodecomposition of
endosulfan and related products in thin films by ultraviolet light irradiation.
Journal of Agricultural and Food Chemistry 20(5):954-956.
05003004 Chopra, N.M.; Mahfouz, A.M. (1977) Metabolism of endosulfan I, endosulfan II,
and endosulfan sulfate in tobacco leaf. Journal of Agricultural and Food
Chemistry 25(l):32-36.
05003007 Martens, R. (1976) Degradation of [8,9-14C]endosulfan by soil microorganisms.
Applied and Environmental Microbiology 31(6):853-858.
05003085 Kavadia, V.S.; Noor, A.; Kathpal, T.S. (1978) Movement and residues of
endosulfan in maize plants. Indian Journal of Agricultural Science
48(3):176-178.
05003103 Amminikutty, C.K.; Rege, M.S. (1977) Effects of acute and chronic exposure to
pesticides, Thiodan E_C_ 35 and Agallol '3' on the liver of widow
tetra-Gymnocorymbus ternetzi~(Boulenger). Indian Journal of Experimental
Biology 15(3): 197-200.
05003222 Gorbach, S.G; Christ, O.E.; Kellner, H.M.; Kloss, G; Boerner, E. (1968)
Metabolism of Endosulfan in Milk Sheep. Journal of Agriculture and Food
Chemistry 16(6):950-953.
177
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
05003336 Stewart, D.K.R.; Cairns, K.G. (1974) Endosulfan persistence in soil and uptake
by potato tubers. Journal of Agricultural and Food Chemistry 22(6):984-986.
05003395 Burke, J.; Mills, P.A. (1963) Microcoulometric gas chromatographic
determination of Thiodan and Tedion in green vegetables. Journal of the
Association of Official Agricultural Chemists 46(2): 177-182.
05003801 Chopra, N.M.; Mahfouz, A.M. (1977) Further investigations into the metabolism
of endosulfan I, endosulfan II and endosulfan sulfate in tobacco leaf. Beitraege
zur Tabakforschung 9(3):176-179.
05003875 Gentile, A.G.; Gallagher, K.J.; Santner, Z. (1971) Effect of some formulated
insecticides on pollen germination in tomato and petunia. Journal of Economic
Entomology 64(4):916-919.
05003877 Frank, R.; Smith, E.H.; Braun, H.E.; Holdrinet, M.; McWade, J.W. (1975)
Organochlorine insecticides and industrial pollutants in the milk supply of the
southern region of Ontario, Canada. Journal of Milk and Food Technology
38(2):65-72.
05004385 Terranova, A.C.; Ware, G.W. (1963) Studies of endosulfan in bean plants by
paper and gas chromatography. Journal of Economic Entomology 56(5): 596-599.
05004388 Rosen, D. (1967) Effect of commercial pesticides on the fecundity and survival
of~Aphytis holoxanthus~(Hymenoptera: Aphelinidae). Israel Journal of
Agricultural Research 17(l):47-52.
05004620 Harrison, R.B.; Holmes, D.C.; Roburn, J.; Tatton, J.O. (1967) The fate of some
organochlorine pesticides on leaves. Journal of the Science of Food and
Agriculture 18(1): 10-15.
05008271 Macek, K.J.; Lindberg, M.A.; Sauter, S.; Buxton, K.S.; Costa, P.A. (1976)
Toxicity of Four Pesticides to Water Fleas and Fathead Minnows. Duluth, Minn.:
U.S. Environmental Protection Agency, Environmental Research Laboratory.
178
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
(EPA report no. EPA-600/3-76-099; available from: NTIS, Springfield, VA;
PB-262912) .
05018169 Terranova, A.C. (1962) Translocation and metabolism studies of Thiodan in bean
plants by paper chromatography. Pages 33-34,~In~Proceeedings of the North
Central Branch of the Entomological Society of America. Vol. XVII. Wooster,
Ohio: Entomological Society of American, North Central Branch.
40024400 FMC Corp. (1986) Effects on Pesticide Handlers of Exposure to Thiodan 3 EC
Endosulfan Sprays.
40060601 Saxena, A. (1986) Laboratory Volatility Study of Endosulfan: Final Report:
Laboratory Project No. 6015-291. Unpublished study prepared by Hazleton
Laboratories America, Inc. 80 p.
40094602 Johnson&Finley / 1980
40098001 Mayer, F. L., and M. R. Ellersieck. 1986. Manual of acute toxicity:
interpretation and data base for 410 chemicals and 66 species of freshwater
animals. U.S. Department of the Interior, Fish and Wildlife Service, Resource
Publication 160.
40112501 Terrel, Y. (1986) (Thiogard Flowable)~Acute Inhalation Toxicology (LC--50
Rat): Project ID: 86-545. Unpublished study prepared by American Standards
Biosciences Corp. 37 p.
40223601 Craine, E. (1986) A Dermal Absorption Study in Rats with Carbon 14
Endosulfan: (Alternative Version of Study Report MRID No.: 40040701):
Laboratory Project ID No. WIL-39028. Unpublished study prepared by WIL
Laboratories, Inc. 90 p.
40228401 Mayer, F. L., and M. R. Ellersieck. 1986. Manual of acute toxicity:
interpretation and data base for 410 chemicals and 66 species of freshwater
animals. U.S. Department of the Interior, Fish and Wildlife Service, Resource
Publication 160.
179
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
40261300 American Hoechst Corp. (1987) Submission of Toxicology Data in Support of the
Reregi strati on Process of Endosulfan.
40261301 Graney, R. (1987) Avian Risk Assessment of Endosulfan. Unpublished study
prepared by Hoechst-Roussel Agri-Vet Co. 9 p.
40261302 Beavers, I; Frank, P.; Jaber, M. (1987) Endosulfan Technical Substance (Code:
HOE 002671 OIZD95 0005): A One-generation Reproduction Study with the
Mallard (Anas platyrhynchos): Lab Project No. 125-137. Unpublished study
prepared by Wildlife International Ltd. 146 p.
40261303 Beavers, I; Frank, P.; Jaber, M. (1987) Endosulfan Technical Substance (Code:
HOE 002671 OI ZD95 0005): A One-generation Reproduction Study with the
Bobwhite (Colinus virginianus): Lab Project No. 125-134. Unpublished study
prepared by Wildlife International Ltd. 144 p.
40303900 American Hoechst Corp. (1987) Submission of Dislodgeable Foliar Residue
Study in Response to Special Data Call-in Notice for Thiodan Tech.
40303901 Baugher, D. (1987) Dislodgeable Foliar Residues and Surrogate-based Exposure
Estimates for Workers Reentering Tree Fruits and Tomatoes Treated with
Thiodan 50 WP Insecticide (Endosulfan): Lab. Proj. ID No. END-87065.
Unpublished compilation prepared by American Hoechst Corp. 94 p.
40335000 Hoechst Celanese Corp. (1987) Submission of Data in Support of the
Reregi strati on Process of Endosulfan: Toxicology Data.
40476500 FMC Corp. (1987) Submission of Data in Response to EPA Data Call In Notice
for Endosulfan: Product Chemistry Data.
40476501 Shuttleworth, J. (1987) Response to EPA Data Call In Notice for Product
Chemistry Data Relating to Potential Formation of Halogenated
Dibenzo-p-Dioxin or Dibenzofuran Contaminants in Certain Active Ingredients:
Endosulfan. Unpublished compilation prepared by FMC Corp. 20 p.
180
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
40476502 Shuttleworth, J. (1987) Response to EPA Data Call In Notice for Product
Chemistry Data Relating to Potential Formation of Halogenated
Dibenzo-p-Dioxin or Dibenzofuran Contaminants in Certain Active Ingredients:
Endosulfan. Unpublished compilation prepared by FMC Corp. 18 p.
40476503 Shuttleworth, J. (1987) Response to EPA Data Call In Notice for Product
Chemistry Data Relating to Potential Formation of Halogenated
Dibenzo-p-Dioxin or Dibenzofuran Contaminants in Certain Active Ingredients:
Endosulfan. Unpublished compilation prepared by FMC Corp. 18 p.
40476504 Shuttleworth, J. (1987) Response to EPA Data Call In Notice for Product
Chemistry Data Relating to Potential Formation of Halogenated
Dibenzo-p-Dioxin or Dibenzofuran Contaminated in Certain Active Ingredients:
Endosulfan. Unpublished study prepared by FMC Corp. 20 p.
40476505 Shuttleworth, J. (1987) Response to EPA Data Call In Notice for Product
Chemistry Data Relating to Potential Formation of Halogenated
Dibenzo-p-Dioxin or Dibenzofuran Contaminants in Certain Active Ingredients:
Endosulfan. Unpublished compilation prepared by FMC Corp. 22 p.
40496200 Makhteshim Chemical Works Ltd. (1987) Submission of Chemistry Data in
Response to Data Call-in Relating to Potential Formation of Halogenated
Dibenzo-p-dioxin in Thionex (Endosulfan).
40496201 Makhteshim Chemical Works Ltd. (1987) Thionex (Endosulfan) - Product
Chemistry Data: R-4773. Unpublished study prepared by the Registration Dept.
9 p.
40496300 Makhteshim Chemical Works Ltd. (1988) Submission of Chemistry Data in
Response to Data Call-in Relating to Potential Formation of Contaminants in
Thionex 35WP (Endosulfan). 9 p.
40496301 Makhteshim Chemical Works Ltd. (1987) Thionex (Endosulfan) - Product
Chemistry Data: R-4773. Unpublished study prepared by the Registration Dept.
9 p.
181
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
40496400 Makhteshim Chemical Works Ltd. (1988) Submission of Chemistry Data in
Support of Thionex (Endosulfan).
40496401 Registration Dept. Makhteshim Chemical Works Ltd. (1987) Thionex
(Endosulfan)—Product Chemistry Data: Laboratory Project ID: R-4773.
Unpublished study. 9 p.
40496500 Makhteshim Chemical Works Ltd. (1988) Submission of Chemistry Data in
Support of Thionex (Endosulfan).
40496501 Registration Dept. Makhteshim Chemical Works Ltd. (1987) Thionex
(Endosulfan)—Product Chemistry Data: Laboratory Project ID: R-4773.
Unpublished study. 9 p.
40496600 Makhteshim Chemical Works Ltd. (1988) Submission of Chemistry Data in
Support of Thionex (Endosulfan).
40496601 Registration Dept. Makhteshim Chemical Works Ltd. (1987) Thionex
(Endosulfan)—Product Chemistry Data: Laboratory Project ID: R-4773.
Unpublished study. 37 p.
40573800 Hoechst Celanese Corp. (1988) Submission of a 30-day Feeding Study in Rats in
Response to EPA's Reviews of the Subchronic Oral Toxicity Study on
Endosulfan.
40573801 Carmines, E.; O'Grodnick, J. (1988) Summary of the Subchronic Toxicity of
Endosulfan. Unpublished study prepared by Hoechst Celanese Corp. 6 p.
40583000 Sureco, Inc. (1988) Submission of Data To Support the Registration of Thiograd
Flowable: Toxicology Data.
40623100 Uniroyal Chemical Co. (1988) Submission of Chemistry Data in Sup port of
Diclofop-methyl and Endosulfan.
182
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
40623101 Dehmer; Kaiser (1987) Endosulfan Technical: Description of Beginning
Materials and Manufacturing Process: Laboratory Project No. 87/2: A 36864.
Unpublished compilation prepared by Hoechst Ag. 18 p.
40623102 Sarafm, R. (1987) HOE 002671 (Endosulfan): Discussion of the Formation of
Impurities in the Technical Grade Substance: Laboratory Project No. (B) 179/87:
A 36812. Unpublished compilation prepared by Hoechst Ag. 18 p.
40623103 Goerlitz, G. (1987) HOE 002671 (Endosulfan): Analysis for Polychlorinated
Dibenzodioxins (PCDD) and Polychlorinated Dibenzofurans (PCDF): Laboratory
Project No. (B) 189/87: A 36893. Unpublished compilation prepared by Hoechst
Ag. 13 p.
40648800 Hoechst Celanese Corp. (1988) Submission of Data To Support the Registration
of Thiodan Technical: Toxicology Data.
40767600 Hoechst Celanese Corp. (1988) Submission of Data To Support Registration of
Endosulfan: Toxicology Data.
40767601 Leist, K.; Mayer, D. (1984) Endosulfan-Active Ingredient Technical (...): 30-Day
Feeding Study in Adult Male Wistar Rats: Project No. 84.0585. Unpublished
study prepared by Hoechst Ag. 321 p.
40792401 Donaubaurer, H. (1988) Endosulfan - Substance Technical: Carcinogenicity
Study in Mice 24 Month Feeding Study: Project ID. A38008. Unpublished study
prepared by Hoechst Aktiengesellschaft. 3988 p.
40975801 Fischer, R. (1989) Assessment of the Fate and Effects of Endosulfan on Aquatic
Ecosystems Adjacent to Agricultural Fields Planted in Tomatoes: Progress Report
No. 5. Unpublished study prepared by Battelle, Columbus Laboratories. 19 p.
41025100 Hoechst Celanese Corporation (1989) Submission of Petition for Import
Tolerance on Dried Hops and Spent Hops for the Chemical, Endosulfan.
183
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
41025101 Krebs, B.; Idstein, H. (1989) HOE 002671 (Endosulfan): Determination of alpha-,
beta-Endosulfan and Endosulfansulfate in Green Hops and Dried Hops:
Laboratory Project ID No. LEA/R88/090. Unpublished study prepared by
Technische Universitat Munchen. 235 p.
41025102 Krebs, B.; Idstein, H. (1989) Thiodan-35 Wettable Powder...Determination of
Residues of alpha-, beta-Endolsulfan and Endosulfansulfate in Treated Dried
Hops and Its Processed Fractions from the Processing of Hops into Beer:
Laboratory Project ID No. LEA/R88/089. Unpublished study prepared by
Technische Universitat Munchen. 106 p.
41048500 Hoechst Celanese Corp. (1989) Submission of Toxicity Data to Support the
Endulfan Registration.
41048501 Carmines, E. (1989) Evaluation of the Human Hazards and Risks Associated with
the Application of Endosulfan: Summary. Unpublished study prepared by
Hoechst Celanese Corp. 23 p.
41048502 Baugher, D. (1989) Exposure of Mixer/Loader/Applicators to Thiodan 3 EC
Insecticide Applied to Fruit Trees by Airblast Equipment in California, 1987:
Laboratory Project ID No. 24587. Unpublished study prepared by Hoechst
Celanese Corp. 262 p.
41048503 Lachman, G. (1987) HOE 002671-(5a, 9a-14-C): Dermal Absorption of [Carbon
14]--Endosulfan in Rhesus Monkeys: Laboratory Project ID No. BIEV-V-66.697.
Unpublished study prepared by Hoechst Celanese Corp. 54 p.
41048504 Craine, E. (1988) A Dermal Absorption Study in Rats with [Carbon]-Endosulfan
with Extended Test Duration: Laboratory Project ID No. WIL 39029.
Unpublished study prepared by Hoechst Celanese Corp. 43 p.
41048505 Thevenaz, P.; Luetemeier, H.; Chevalier, H.; et al. (1988) Endosulfan-
Emulsifiable Concentrate (Code: HOE 002671 OIEC34 A101): Subchronic
(4-week) Repeated Dose Dermal Toxicity Study in Rats: Laboratory Project ID
No. 094590. Unpublished study prepared by Hoechst Celanese Corp. 652 p.
184
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
41048506 Ebert, E. (1987) Endosulfan-Water-dispersible Powder (50%) (Code: HOE
002671 OIWP50 A501): Subchronic Dermal Toxicity (21 Treatments in 30
Days) in the Wistar Rat: Laboratory Project ID No. 87.0664. Unpublished study
prepared by Hoechst AG. 704 p.
41099500 Hoechst Celanese Corp. (1989) Submission of Toxicity Data in Support of
Reregi strati on of Endosulfan.
41099501 Brunk, R. (1989) Endosulfan-Sub stance Technical: Testing for Toxicity by
Repeated Oral Administration (1-Year Feeding Study) to Beagle Dogs: Project ID
87.0643. Unpublished study prepared by Hoechst Aktiengesellschaft. 813 p.
41099502 Ruckman, S.; Waterson, L.; Crook, D.; et al. (1989) Endosulfan-Substance
Technical: Combined Chronic Toxi city /Carcinogen! city Study: 104-Week
Feeding in Rats: Project ID HST 289/881076. Unpublished study prepared by
Huntingdon Research Centre Ltd. 1601 p.
41164100 Hoechst Celanese (1989) Submission of Toxicological Data to Support the
Continued Registration of Endosulfan.
41164101 Cornaby, B.; Maciorowski, A.; Griffith, M.; et al. (1989) Assessment of the Fate
and Effects of Endosulfan on Aquatic Ecosystems Adjacent to Agricultural Fields
Planted with Tomatoes: Laboratory Project ID N0954-5700. Unpublished study
prepared by Battelle in cooperation with Hickey's Agri-Services Laboratory,
Inc. 2260 p.
41183400 Micro Flo Co. (1989) Submission of Product Chemistry and Toxicity Data in
Support of Registration of Endosulfan 3 EC.
41183401 Tucker, D. (1986) Product Chemistry for Endosulfan 3EC: Project ID
51036/END3EC. Unpublished study prepared by Chempax. 60 p.
41183402 Rosenfeld, G. (1985) Acute Oral Toxicity Study in Rats: Test Article: Endosulfan
3 E.C.: C.S.E. Project #88687-7: Study No. 1235A. Unpublished study prepared
by Cosmopolitan Safety Evaluation, Inc. 45 p.
185
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
41183403 Rosenfeld, G. (1985) Acute Dermal Toxicity in Rabbits: Test Article Endosulfan
3 B.C.: C.S.E. Project No. S8687-7: Study No. 1235B. Unpublished study
prepared by Cosmopolitan Safety Evaluation, Inc. 35 p.
41183404 Rosenfeld, G. (1985) Acute Inhalation Toxicity Study in Rats: Test Article:
Endosulfan 3 E.G.: Study No. 1235C. Unpublished study prepared by
Cosmopolitan Safety Evaluation, Inc. 45 p.
41183405 Rosenfeld, G. (1985) Primary Eye Irritation Study in Rabbits: Test Article:
Endosulfan 3 E.G.: C.S.E. Project No. S8687-7: Study No. 1235D. Unpublished
study prepared by Cosmopolitan Safety Evaluation, Inc. 26 p.
41183406 Rosenfeld, G. (1985) Primary Dermal Irritation Study in Rabbits: Test Article:
Endosulfan 3 E.C.: C.S.E. No. S8687-7: Study No. 1235E. Unpublished study
prepared by Cosmopolitan Safety Evaluation, Inc. 17 p.
41183407 Rosenfeld, G. (1989) Guinea Pig Sensitization Study (Buehler): Test Article:
Endosulfan 3 E.G.: Study No. 1235F. Unpublished study prepared by
Cosmopolitan Safety Evaluation, Inc. 18 p.
41183500 Micro Flo Co. (1989) Submission of Data To Support Registration of Endosulfan
50WP 51036: Toxicology Studies.
41183501 Tucker, D. (1987) Product Chemistry For Endosulfan 50WP 51036: Project ID:
MICEND50WP. Unpublished study prepared by Chem Pax. 66 p.
41183502 Schulz, M. (1985) Report: Acute Oral Toxicity Study in Rats of Endosulfan
50WP-INTOX Sample No. 494: Protocol No. LAN-AT-010. Unpublished study
prepared by Intox Laboratories. 146 p.
41183503 Schulz, M. (1985) Report: Acute Dermal Toxicity Study in Rabbits of Endosulfan
50 WP Intox Sample No. 494; Protocol No. LAN-AT-008. Unpublished study
prepared by Intox Laboratories. 57 p.
186
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
41183504 Rosenfeld, G. (1985) Acute Inhalation Toxicity Study in Rats: Test Article:
Endosulfan 50 W.P.: Study No. 1237C. Unpublished study prepared by
Cosmopolitan Safety Evlauation (C.S.E.), Inc. 75 p.
41183505 Frith, C. (1985) Report: Primary Eye Irritation Study of Endosulfan 50 WP: Intox
Sample No. 494: Project No. LAN-AT-003. Unpublished study prepared by
Intox Laboratories. 19 p.
41183506 Frith, C. (1985) Report: Primary Dermal Irritation Study of Endosulfan 50WP
Intox Sample No. 494: Project No. LAN-AT-004. Unpublished study prepared
by Intox Laboratories. 18 p.
41183507 Schulz, M. (1985) Report: Guinea Pig Maximization Test Using Endosulfan 50
WP Intox Sample No. 494: Protocol No. LAN-AT-009. Unpublished study
prepared by Intox Laboratories. 18 p.
41309700 Hoechst Celanese Corp. (1989) Submission of Residue Data in Support
of Endosulfan.
41309701 Mester, T. (1989) Endosulfan Terrestrial/Runoff Study on Cotton in South
Carolina: Project ID 1641-87-65-03-11B-01. Unpublished study prepared by
Hoechst AG. in Association with Landis Associates. 876 p.
41309702 Hacker, L. (1989) Endosulfan (Thiodan 3 EC): Field Dissipation Study of
Terrestrial Uses on Tomatoes in Georgia/U.S. A: Lab Project Number:
1641/87/65/03/08D/03 : CRO41/87. Unpublished study prepared by Hoechst
AG in Association with Landis Associates, Inc. 553 p.
41311500 Hoechst Celanese Corp. (1989) Submission of Response to Toxicological Review
of Tolerence on Hops in Support of Petition for Endosulfan.
41311501 Langer, K.; Leist, K. (1989) Petitioners Responses to EPA's Toxicology Branch
Review Dated June 29, 1989 in Support of the Petition (No. 9H5579) for an
Import Tolerence for Endosulfan on Dried Hops (10 ppm) and Spent Hops (10
187
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
ppm). Unpublished study prepared by Hoechst Aktiengesellschaft, Pharma
Forschung. 38 p.
41339100 Chas H. Lilly Co. (1989) Submission of Data To Support Registration of
Endosulfan: Toxicology Studies.
41339101 Robbins, G. (1989) Acute Oral Toxicity Study in Rats: SA-50 Brand Thiodan .75
Insect Spray: Lab Project No. A2039. Unpublished study prepared by
Cosmopolitan Safety Evaluation, Inc. 26 p.
41339102 Robbins, G. (1989) Acute Dermal Toxicity in Rabbits: SA-50 Brand Thiodan .75
Insect Spray: Lab Project Number: B2039. Unpublished study prepared by
Cosmopolitan Safety Evaluation, Inc. 36 p.
41339103 Robbins, G. (1989) Primary Eye Irritation Study in Rabbits: SA-50 Brand
Thiodan .75 Insect Spray: Lab Project Number: D2039. Unpublished study
prepared by Cosmopolitan Safety Evaluation, Inc. 25 p.
41339104 Robbins, G. (1989) Primary Dermal Irritation Study in Rabbits: SA-50 Brand
Thiodan .75 Insect Spray: Lab Project Number: E2039. Unpublished study
prepared by Cosmopolitan Safety Evaluation, Inc. 14 p.
41353600 Southern Agricultural Insecticides, Inc. (1990) Submission of Toxicological Data
to Support the Registration of SA-50 Brand Thiodan .75 Insect Spray.
41353601 Robbins, G. (1989) Acute Oral Toxicity Study in Rats: Lab Project ID.: A2039.
Unpublished study prepared by Cosmopolitan Safety Evaluation, Inc. 26 p.
41353602 Robbins, G. (1989) Acute Dermal Toxicity in Rabbits: SA-50 Brand Thiodan .75
Insect Spray: Lab Project Number: 82039. Unpublished study prepared by
Cosmopolitan Safety Evaluation, Inc. 36 p,
41353603 Holbert, M. (1989) Acute Inhalation Toxicity Study-Rats...for the End Use
Product SA-50 Brand Thiodan .75 Insect Spray: Lab Project Number: 6510-89.
Unpublished study prepared by Stillmeadow, Inc., Biological Testing Laboratory.
44 p.
188
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
41353604 Robbins, G. (1989) Primary Eye Irritation Study in Rabbits: SA-50 Brand
Thiodan .75 Insect Spray: Lab Project Number: D2039. Unpublished study
prepared by Cosmopolitan Safety Evaluation, Inc. 25 p.
41353605 Robbins, G. (1989) Primary Dermal Irritation Study in Rabbits: Lab Project
Number: E2039. Unpublished study prepared by Cosmopolitan Safety
Evaluation, Inc. 14 p.
41353606 Tucker, D. (1989) Product Chemistry According to the Pesticide Assessment...for
the End Use Product: SA-50 Brand .75 Thiodan Insecticide Spray: Lab Project
ID.: SA-TH-EU-2. Unpublished study prepared by Chempax. 24 p.
41400500 FMC Corp. (1990) Submission of Toxicity Data in Support of Thiodan
2 C.O. EC Insecticide.
41400501 Freeman, C. (1989) Thiodan 2 C.O.EC: Acute Oral Toxicity in Rats:
Lab Project Number: A89-2939. Unpublished study prepared by FMC
Toxicology Laboratory. 35 p.
41400502 Freeman, C. (1989) Thiodan 2 C.O. EC: Acute Dermal Toxicity Study
in Rabbits: Lab Project Number: A89-2940. Unpublished study
prepared by FMC Toxicology Laboratory. 32 p.
41400503 Mount, E. (1990) Thiodan 2 C.O. EC: Acute Inhalation Toxicity Study
in Rats: Lab Project Number: A89-2941. Unpublished study pre-
pared by FMC Toxicology Laboratory. 72 p.
41400504 Freeman, C. (1989) Thiodan 2 C.O. EC: Primary Eye Irritation Study
in Rabbits: Lab Project Number: A89-2942. Unpublished study
prepared by FMC Toxicology Laboratory. 15 p.
41400505 Freeman, C. (1989) Thiodan 2 C.O. EC: Primary Skin Irritation Study
in Rabbits: Lab Project Number: A89-2943. Unpublished study
prepared by FMC Toxicology Laboratory. 21 p.
189
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
41400506 Freeman, C. (1989) Thiodan 2 C.O. EC: Skin Sensitization Study in
Guinea Pigs: Lab Project Number: A89-2944. Unpublished study
prepared by FMC Toxicology Laboratory. 21 p.
41412900 Hoechst Celanese Corp. (1990) Submission of Metabolism Data for
Endosulfan Reregi strati on.
41412901 Goerlitz, G.; Rutz, U. (1988) Endosulfan Abiotic Hydrolysis of the Two Isomers
HOE 052618 (Alpha-Endosulfan), HOE 052619 (Beta-Endosulfan) as a Function
of pH: Lab Project Number: CP014/88. Unpublished study prepared by Hoechst
Aktiengesellschaft Analytisches Laboratorium. 59 p.
41412902 Stumpf, K.; Gildemeister, H.; Dambach, P.; et al. (1988) HOE 002671-14-C
Aerobic Metabolism of Endosulfan in Soil and the Influence of Increased
Microbial Biomass at 28 [Degrees]: Project Nos. A 39429; CB017/86.
Unpublished study prepared by Hoechst Aktiengesellschaft Analytisches
Laboratorium. 49 p.
41412903 Gildemeister, H. (1985) HOE 002671-14-C Anaerobic Soil Metabolism Study
with the Insecticide Endosulfan: Project Nos. (B) 91/85; A 30759. Unpublished
study prepared by Hoechst Aktiengesellschaft Analytisches Laboratorium. 27 p.
41412904 Gildemeister, H. (1988) HOE 002671-14C Anaerobic Metabolism of En-
dosulfan in a Sandy Loam and a Silt Loam Soil: Project Nos.
OI-134/04/03 B; A 37589. Unpublished study prepared by Hoechst
Aktiengesellschaft Analytisches Laboratorium & Radiochemisches
Laboratorium. 44 p.
41412905 Goerlitz, G.; Eyrich, U. (1988) Endosulfan (HOE 002671) Adsorption/Desorption
in the System Soil/Water for the Metabolites HOE 051327 (Endosulfan-sulfate)
and HOE 051329 (Endosulfan-diol): Project Nos. CP068/87 II; A 39353.
Unpublished study prepared by Hoechst Aktiengesellschaft Analytisches
Laboratorium. 49 p.
190
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
41412906 Goerlitz, G. (1988) Endosulfan (HOE 002671) Adsorption/Desorption in the
System Soil/Water for HOE 052618 (Alpha-Endosulfan), HOE 052619
(Beta-Endosulfan): Project Nos. A37591; CP068/87 I. Unpublished study
prepared by Hoechst Aktiengesellschaft Analytisches Laboratorium. 76 p.
41415701 Stumpf, K. (1987) HOE 00267l-e'Carbon 14|: Photodegradation of
alpha-Endosulfan (HOE 052618) and beta-Endosulfan (HOE 052619) in Water:
Lab Project ID No. CB074/87: Hoechst AG Project ID A 37588. Unpublished
prepared by Hoechst Aktiengesellschaft, Analytisches Laboratorium. 40 p.
41421500 Hoechst Celanese (1990) Submission of Product Chemistry Data in
Support of Reregi strati on of Endosulfan.
41421501 Sarafm, R. (1982) HOE 002671 (Endosulfan), HOE 052618 (Alpha-Endosulfan)
and HOE 052619 (Beta—Endosulfan)—Vapor Pressures: Lab Project Number: S
82/320: S 82/321: S 82/322. Unpublished study prepared by Hoechst
Aktiengesellschaft. 20 p.
41421502 Asshauer, J. (1979) HOE 052618 and HOE 052619 (Alpha-and Beta
Endosulfan): Solubility in Water: Lab Project Number: B 154/87: A 36704.
Unpublished study prepared by Hoechst Aktiengesellschaft. 13 p.
41421503 Asshauer, J.; Sarafm, R. (1979) HOE 052618 and HOE 052619 (Alpha &
Beta—Endosulfan): Partition Coefficient Octanol/Water: Lab Project Number: B
124/87: A 36576. Unpublished study prepared by Hoechst Aktiengesellschaft.
21 p.
41430700 FMC Corp. (1990) Submission of Data To Support Registration of
Endosulfan: Soil Photolysis Study. Transmittal of 1 study.
41430701 Ruzo, L.; McGovern, P.; Shepler, K. (1988) Soil Surface Photolysis of [carbon
14]Endosulfan in Natural Sunlight: Lab Project No: FMC/323E1388/E1: 125W-1:
125W. Unpublished study prepared by Pharmacology and Toxicology Research
Laboratory. 87 p.
191
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
41468600 Hoechst Celanese (1990) Submission of field dissipation/runoff
data in support of the reregi strati on of Endosulfan.
41468601 Mester, T. (1990) Endosulfan (LX165-03): Terrestrial Runoff Study on Cotton In
California with Furrow Irrigation: Final Report: Project Nos: R328703;
CR040/87. Unpublished study prepared by by Hoechst Aktiengesellschaft and
Landis International. 693 p.
41490101 Knowler, E. (1990) Silver Impregnated Activated Carbon blended with Granular
Activated Carbon: Product Chemistry Data: 0Kelco Bacteriostatic Water
Treatment Unit Whole-house Model KAH-1500|. Unpublished study prepared by
Kelco Water Engineering, Inc. in cooperation with Calgon Carbon Corp. 10 p.
41537200 Makhteshim-Agan (America) Inc. (1990) Submission of Chemistry Data
in Support of Endosulfan Registration.
41537201 Makhteshim Chemical Works Ltd. (1990) Discussion on the Potential for
Halogenated Dibenzo-p-Dioxin/Dibenzofuran Formation in Endosulfan.
Unpublished study, lip.
41567800 FMC Corp. (1990) Submission of Data To Support Amendment to Regi-
stration Application for Thiodan 2 C.O. EC: Toxicology Study.
41567801 Freeman, C. (1989) Thiodan 2 C. O. EC: Skin Sensitization Study in
Guinea Pigs: Lab Project Number: A89-2944. Unpublished study
prepared by FMC Corp. 18 p.
41648100 Clarke Mosquito Control Products Co., Inc. (1990) Submission of
Product Chemistry Data to Support the Registration of Clout.
41648101 Sawyer, R. (1989) Product Chemistry: ULV Mosquito Master 4+12: Lab
Project Number: CLOUT. Unpublished study prepared by Riverdale
Chemical Company. 6 p.
192
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
41667500 Hoechst Celanese Corp. (1990) Submission of supplementary toxicity
data to support the reregi strati on of Endosulfan.
41667501 Hack, R.; Leist, K. (1990) Endosulfan—Active Ingredient Technical: Testing for
Subchronic Inhalation Toxicity...in Wistar Rats (Translation): Supplement to
MRID 00147183. Lab Project Number A 44124; 90.1047. Unpublished study
prepared by Hoechst Aktiengesellschaft. 6 p.
41667502 Hack, R.; Leist, K. (1990) Endosulfan-Active Ingredient Technical, Repeated
Dose Inhalation Toxicity. . . in Wistar Rats; Preliminary Study (Range Finding) to
Report No. 84. 0539: Supplement to MRID 00147183: Lab Project Number: A
44125:90. 1057. Unpublished study prepared by Hoechst Aktiengesellschaft. 29
P-
41667503 Leist, K. (1990) Registrant's Response to EPA's Toxicology Branch Review of
Endosulfan. . . Regarding the Testing for Subchronic Inhalation Toxicity in Rats
(Commentary to MRIDS 00147183 and 00147196): Lab Project Number 90.1057;
90.1047. Unpublished study prepared by Hoechst Celanese Corp. 10 p.
41715200 Hoechst Celanese Corp. (1990) Submission of Revised Mixer/Loader/
Applicator Study to Support Registration of Endosulfan.
41715201 Baugher, D. (19901) Exposure of Mixer/Loader/Applicators to Thiodan 3 EC
Insecticide Applied to Fruit Trees by Airblast Equipment in California, 1987
Original Issue: Lab Project Number: 24587. Unpublished study prepared by
Orius Associates Inc., and EN-CAS Analytical Laboratories. 59 p.
41775500 Hoechst Celanese Corp. (1991) Submission of Supplemental Data To
Support Registration of Endosulfan: Toxicology Study.
41775501 Langer, K. (1991) Supplement To: 30-Day Feeding Study in Adult Male Wistar
Rats: Lab Project Number: 91/0078. Unpublished study prepared by Hoechst
Aktiengesellschaft. 5 p.
41799300 Hoechst Celanese (1991) Submission of Toxicological Summary and
193
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
Risk Assessment data in support of Endosulfan in response to
EPA's evaluation of the existing data base dated Nov. 20, 1990.
41799301 Katz, A.; Hawk, F.; Leist, K-H. (1991) Toxicology Summary and Risk
Assessment: The Registratnts Response to EPA's Evaluation of the
Existing Data Base dated Nov. 20, 1990. Unpublished study pre-
pared by Hoechst Celanese Corp. 32 p.
41912200 Hoechst Celanese Corp. (1991) Submission of Dietary Exposure Analysis Data
To Support Reregistration of Endosulfan.
41912201 Tomerlin, J. (1991) Anticipated Residues and Chronic Dietary Exposure Analysis
for Endosulfan Under a Revised Product Label: Lab Project Number: HR ENDO
6/91. Unpublished study prepared by Technical Assessment Systems, Inc. 195 p.
41931200 Hoechst Celanese (1991) Submission of Data to Support the Reregistrati on
Process of Endosulfan: Residual Data.
41931201 Tomerlin, R. (1991) Anticipated Residues and Chronic Dietary Exposure
Analysis for Endosulfan Under a Revised Product Label: Lab Project Number:
HR ENDO 6/91. Unpublished study prepared by Hoechst-Celanese Corp. 195 p.
42237900 Georgia Dept, of Agriculture (1992) Submission of Investigative
Reports in Response to Section 6(a)(2) FIFRA Requirements for
the Use and Misuse of the Following Pesticides [Prep, Folex,
Cythion, Bravo, ..., Methyl Parathion and Guthion].
42237901 Georgia Dept., of Agriculture (1992) Investigative Reports of
Fish Kills and Bee Kills Allegedly Caused by the Use/Misuse of
Various Agricultural Pesticides. Unpublished study. 496 p.
42298600 FMC Corp. (1992) Submission of Section 6(a)(2) Data To Support
FIFRA Requirements for DBCP, EDB, Dragnet, Killmaster, Golden
Leaf Tobacco Spray and Furadan Adverse Effects/Incident Reports.
194
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
42298601 Steinberg, J. (1992) Letter Sent to Office of Pesticide Programs dated April 27,
1992: [Pending claims and lawsuits involving DBCP, EDB, Dragnet, Killmaster,
Golden Leaf Tobacco Spray and Furadan]. Prepared by FMC Corp. 3 p.
42302600 FMC Corp. (1992) Submission of data under FIFRA 6(a)(2) status
concerning incident reports involving various formulated products.
42302601 Lauber, J. (1992) Letter Sent to Frank Davido, OPP from J. Lauber dated March
13, 1992: Summary of telephone calls (incident reports) received by FMC
concerning various products. Prepared by FMC Corp. 4 p.
42302900 FMC Corp. (1992) Submission of data under FIFRA 6(a)(2) status
involving incidents with various formulated products (summaries)
42302901 Lauber, J. (1992) Letter Sent to Frank Davido, OPP from J. J.
Lauber dated March 3, 1992 containing summaries of incident
reports (via telephone calls) involving several formulated
products. 14 p.
42586600 Drexel Chemical Co. (1992) Submission of product chemistry data
(commentary and original data) to support the registration of
HCB and PCB and Drexel Endosulfan Technical.
42586601 Haefele, L. (1992) Comments on the Improbability of
Contamination of Drexel Endosulfan with Hexachlorobenzene and
Pentachlorobenzene and with Halogenated Dibenzo-p-Dioxins and
Dibenzofurans. Unpublished study prepared by Drexel Chemical
Co. 7 p.
42586700 Drexel Chemical Co. (1992) Submittal of Product Chemistry Data in
response to the Data Call-in for Endosulfan.
195
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
42586701 Haefele, L. (1992) Comments on the Improbability of Contamination of Drexel
Endosulfan with Hexachlorobenzene and Pentachlorobenzene and with
Halogenated Dibenzo-p-dioxins and Dibenzofurans. Unpublished study prepared
by Drexel Chemical Co. 7 p.
42919100 Makhteshim Chemical Works, Ltd. (1993) Submission of Product
Chemistry in Support of Endosulfan Data Call-in.
42919101 Makhteshim Chemical Works, Ltd. (1993) Endosulfan Product Chemistry,
Pesticide Assessment Guideline Series 61: Lab Project Number: R-7420.
Unpublished study prepared by Makhteshim Chemical Works, Ltd. 103 p.
42919102 Ehmann, J. (1993) Hexachlorobenzene and Pentachlorobenzene Quantitation in
Technical Endosulfan: Lab Project Number: 92MAK01. Unpublished study
prepared by Institut Fresenius. 108 p.
42932000 Hoechst Celanese Corp. (1993) Submission of Product Chemistry
Data in Response to DCI Notice of September 2, 1992 for Endosulfan.
42932001 Hommel, K. (1992) Endosulfan (HOE 002671): Determination in the Technical
Grade Active Ingredient and Formulations by Gas Chromatography, Using
Internal Standard Calibration—Analytical Method: Lab Project Number: A 49026:
AL 005/84-1. Unpublished study prepared by Hoechst Aktiengesellschaft. lip.
42932002 Gubert, M.; Hommel, K.; Weller, O. (1993) Determination of Secondary
Components in HOE 002671 (Endosulfan)—Analytical Method: Lab Project
Number: A 51151: AL 008/92-1. Unpublished study prepared by Hoechst
Aktiengesellschaft. 12 p.
42932003 Gubert, M.; Hommel, K.; Weller, W. (1993) Determination of Toluene in
Endosulfan (HOE 002671) Using Gas Chromatography with an Internal Standard
Analytical Method: Lab Project Number: A 51150: AL 009/92-0. Unpublished
study prepared by Hoechst Aktiengesellschaft. lip.
196
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
42932004 Weller, O.; Gubert, M.; Gubert, G. (1993) Validation of the Analytical Methods
AL008/92-1 and AL009/92-0 for the Determination of Organic Impurities and
Toluene in Technical Endosulfan (HOE 002671): Lab Project Number: A 51217:
CP93/041. Unpublished study prepared by Hoechst Aktiengesellschaft. 114 p.
42932005 Weller, O.; Weller, W. (1993) HOE 002671 (Endosulfan): Discussion of the
Formation of Impurities in the Technical Grade Substance: Lab Project Number:
A 51137: OE93/057. Unpublished study prepared by Hoechst Aktiengesellschaft.
17 p.
42932006 Weller, O.; Gubert, M.; Gubert, C. (1993) Endosulfan (HOE 002671): Analysis of
Seven Typical Production Batches: Lab Project Number: A 51214: CP93/045.
Unpublished study prepared by Hoechst Aktiengesellschaft. 100 p.
42932007 Ehmann, J. (1993) Hexachlorobenzene and Pentachlorobenzene Quantitation in
Technical Endosulfan: Lab Project Number: A 51194: 92 HOE 01. Unpublished
study prepared by Institut Fresenius Ingelheim. 104 p.
42957000 Hoechst Celanese Corp. (1993) Submittal of Product Chemistry Data
in Support of FIFRA 6(a)(2) for Endosulfan.
42957400 Makhteshim-Agan of North America (1993) Submission of Product
Chemistry Data in Support of FIFRA 6(a)(2) for Endosulfan.
43069701 Czarnecki, J.; Mayasich, J. (1992) Terrestrial Field Dissipation of Endosulfan
Applied to Cropped and Bareground Plots in California: Lab Project Number:
90-0100: 90-0101: R289011. Unpublished study prepared by Bio/dynamics, Inc.
176 p.
43129100 Hoechst Celanese Corp. (1993) Submittal of Toxicity data in Support of
Registration of Endosulfan.
43129101 Albrecht, M.; Baeder, C. (1993) Endosulfan (HOE 002671 Substance Technical)
(Code: HOE 002671 00 ZD98 0005) Testing for Embryotoxicity in the Wistar Rat
197
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
After Oral Administration: Lab Project Number: RR0663: 92.0695. Unpublished
study prepared by Hoechst Aktiengesellschaft. 239 p.
43244900 Drexel Chemical Co. (1994) Submission of product chemistry data
in response to Special DCI for HCB/PCB in Endosulfan.
43244901 Claussen, F. (1994) Analysis of Endosulfan for Hexachlorobenzene and
Pentachlorobenzene: Lab Project Number: 130S07. Unpublished study prepared
by EPL Bio-Analytical Services, Inc. 58 p.
43268100 Drexel Chemical Co. (1994) Submittal of Product Chemistry Data in
Support of Data Call-in of Drexel Endosulfan Technical
Insecticide.
43268101 Handy, R. (1994) Product Identity and Composition Drexel Endosulfan Technical
Insecticide. Unpublished study prepared by Drexel Chemical Co. 13 p.
43268102 Handy, R. (1994) Analysis and Certification of Product Ingredients Drexel
Endosulfan Technical Insecticide. Unpublished study prepared by Drexel
Chemical Co. 65 p.
43335500 DuPont Ag Products (1994) Submission of Toxicity Data in Support
of FIFRA 6(a)(2) for Oxamyl (Vydate L Insecticide).
43335501 Tillman, P. (1994) Letter sent to Walt Mitchell (DuPont Ag
Products) dated July 11, 1994: Toxicity of oxamyl and other
cotton insecticides to beneficial insects. Prepared by USD A,
Southern Insect Management Lab. 2 p.
43617800 Ciba-Geigy Corp. (1995) Submission of Residues in the Environment
and Hazard to Aquatic Organisms Data in Support of FIFRA 6(a)(2)
for Diazinon.
198
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
43617801 Ross, L. (1991) Preliminary Results of the San Joaquin River Study: March and
April, 1991: (Diazinon, Ethyl Parathion, Carbaryl, Dimethoate, and
Carbofuran...). Unpublished study prepared by State of California, Dept. of
Pesticide Regulation. 17 p.
43617802 Ross, L. (1992) Preliminary Results of the San Joaquin River
Study: Summer 1991: (Diazinon, Ethyl Parathion, Carbaryl,
Dimethoate, and Carbofuran...). Unpublished study prepared by
State of California, Dept. of Pesticide Regulation. 15 p.
43617803 Ross, L. (1992) Preliminary Results of the San Joaquin River
Study: Winter 1991-2: (Diazinon, Ethyl Parathion, Carbaryl,
Dimethoate, and Carbofuran...). Unpublished study prepared by
State of California, Dept. of Pesticide Regulation. 17 p.
43617804 Ross, L. (1993) Preliminary Results of the San Joaquin River
Study: Spring 1992: (Diazinon, Ethyl Parathion, Carbaryl,
Dimethoate, and Carbofuran...). Unpublished study prepared by
State of California, Dept. of Pesticide Regulation. 14 p.
43617805 Ross, L. (1993) Preliminary Results of the San Joaquin River
Study: Summer 1992: (Diazinon, Ethyl Parathion, Carbaryl,
Dimethoate, and Carbofuran...). Unpublished study prepared by
State of California, Dept. of Pesticide Regulation. 15 p.
43617806 Ross, L. (1993) Preliminary Results of the San Joaquin River
Study: Winter 1992-3: (Diazinon, Ethyl Parathion, Carbaryl,
Dimethoate, and Carbofuran...). Unpublished study prepared by
State of California, Dept. of Pesticide Regulation. 16 p.
199
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
43617808 Nordmark, C. (1994) Four River Monitoring Protocol: Revised:
(Includes "Preliminary Results of the Four River Study,
Sacramento River, Winter/Spring 1993-1994"). Unpublished study
prepared by California Department of Pesticide Regulation. 13 p.
43675000 Fermenta Animal Health Co. (1995) Submission of product chemistry data in
support of the registration of Endalfly Insecticide Cattle Ear Tag.
43675001 Shoup, R. (1995) Identity of Ingredients, Manufacturing Process and Discussion
of Formation of Impurities: Technical Endosulfan. Unpublished study prepared
by Fermenta Animal Health Co. 12 p.
43675002 Shoup, R. (1995) Certification of Limits and Analytical Method: Technical
Endosulfan. Unpublished study prepared by Fermenta Animal Health Co. 14 p.
43675003 Shoup, R. (1995) Physical and Chemical Properties: Technical Endosulfan.
Unpublished study prepared by Fermenta Animal Health Co. 4 p.
43812800 AgrEvo USA Co. (1995) Submission of Environmental Fate Data in
Support of the Registration Standard for Endosulfan.
43812801 Stumpf, K.; Dambach, P.; Lenz, O. (1995) Metabolism of (Carbon 14)-Labeled
Endosulfan in Five Soils Under Aerobic Conditions: Code: Hoe 002671, Hoe
052618, Hoe 052619: Lab Project Number: CB88/037: A53618: RR06/A914A.
Unpublished study prepared by Hoechst Schering AgrEvo GmbH. 85 p.
43842000 FMC Corp. (1995) Submission of Residue and Exposure: Reentry
Protection Data in Support of the Registration Standard for Carbofuran.
43842001 Carlson, D. (1995) Soil Residue Dissipation, Dermal Passive
Dosimetry Exposure and Inhalation Passive Dosimetry
Exposure—Potatoes: Justification for Waiver of Carbofuran Data
Call-In. Unpublished study prepared by FMC Corp. 71 p.
200
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
43938400 Plant Products Corp. (1996) Submission of Exposure: Reentry
Protection Data in Support of the Registration Standard for Sulfotepp.
43938401 O'Connell, L.; Fong, H.; Cooper, C.; et al. (1987) A Study to Establish
Degradation Profiles for Six Pesticides (Triforine, Endosulfan, Chlorothalonil,
Sulfotep, Dodemorph Acetate, and Daminozide) Used on Ornamental Foliage in
San Diego County California During Fall 1986: Lab Project Number: HS-1400.
Unpublished study prepared by California Dept. of Food and Agriculture. 19 p.
43960300 AgrEvo USA Co. (1996) Submission of Residue Data in Support of
Import Tolerance Petition for Endosulfan in/on Coffee.
43960301 Gomez, C. (1996) Magnitude of the Residue of Endosulfan in
Coffee Raw Agricultural Commodities and Processed Fractions:
Study Summary Report: Lab Project Number: AA930040: A55741.
Unpublished study prepared by American Agricultural Services,
Inc. (AASI); EN-CAS Analytical Laboratories; and William J.
Englar & Associates, Inc. 12 p.
43960302 Gomez, C. (1996) Magnitude of the Residue of Endosulfan in
Coffee Raw Agricultural Commodities and Processed Fractions:
Final Study Report: Lab Project Number: AA930040: A 55745.
Unpublished study prepared by American Agricultural Services,
Inc. (AASI); EN-CAS Analytical Laboratories; and William J.
Englar & Associates, Inc. 590 p.
43961100 U.S. EPA (1996) Submission of Toxicity Data on 17 Pesticides.
43961101 McCann, J.; Teeters, W.; Urban, D. et al. (1981) A short-term dietary toxicity
test on small mammals, p. 132-142 of the Second Conference of Avian and
Mammalian Wildlife Toxicology, Lamb, D.; Kenaga, E. Eds.; Published in
American Society for Testing and Materials, ASTM STP 757; 1981.
201
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
43972500 E.I. du Pont de Nemours and Co. (1996) Submission of Residue
Monitoring Data in Support of FIFRA 6(a)(2) for Many Pesticides
in Fresh Produce.
43972501 California Environmental Protection Agency (1995) Residues in
Fresh Produce-1993. Unpublished study. 59 p.
44018900 Drexel Chemical Co. (1996) Submission of Product Chemistry Data
in Support of the Application for Registration of Drexel
Endosulfan 3 EC.
44018901 Handy, R. (1996) Product Identity and Composition: Drexel
Endosulfan 3EC: Lab Project Number: ANS96-0001. Unpublished
study prepared by Drexel Chemical Co. 44 p.
44018902 Handy, R. (1996) Analysis and Certification of Product Ingredients: Drexel
Endosulfan 3 EC: Lab Project Number: AN96-0001. Unpublished study prepared
by Drexel Chemical Co. 10 p.
44018903 Handy, R.; West, M. (1996) Physical and Chemical Characteristics of Drexel
Endosulfan 3EC: Lab Project Number: DREX0295. Unpublished study
prepared by Drexel Chemical Co. 7 p.
44082700 AgrEvo USA Co. (1996) Submission of Fate in Plants and Livestock Data in
Support of the Endosulfan Registration Standard.
44082701 Schwab, W. (1995) Endosulfan (Code: Hoe 002671 00 ZE97 0005): Metabolism
in Apples (Malus Sylvestris var. Domesticia) Following Single Treatment of a
Young Tree with (carbon 14)-Labelled Test Substance: Lab Project Number:
CM93/040: A 53662. Unpublished study prepared by Hoechst Schering AgrEvo
GmbH. 53 p.
202
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
44082702 Rupprecht, 1; Smith, S. (1996) Metabolism of (carbon 4)-Endosulfan in Lettuce:
Lab Project Number: 502BJ: A 55811. Unpublished study prepared by AgrEvo
USA Co. 76 p.
44082703 Leah, I; Reynolds, C. (1996) Endosulfan: Distribution, Elimination and the
Nature of the Metabolite Residues in the Milk and Edible Tissues of a Lactating
Cow: Lab Project Number: A 57041: TOX/94306: TOX/94308A. Unpublished
study prepared by AgrEvo UK Ltd. 134 p.
44099100 AgrEvo USA Co. (1996) Submission of Metabolism and Residue Data in
Support of the Endosulfan Registration Standard.
44099101 Buerkle, W. (1995) Endosulfan (Code: Hoe 002671 00 ZE97 0005): Metabolism
in Cucumber (Cucumis sativus) Following Three Treatments with the (carbon
14)-Labeled Test Substance at 7-Day Intervals and a Nominal Rate of 530 g a.i.
/ha Each: Lab Project Number: CM93/039: A 56011: RR06/A013. Unpublished
study prepared by Hoechst Schering AgrEvo GmbH. 81 p.
44099102 Reynolds, C. (1996) Endosulfan: Distribution, Elimination, and the Nature of the
Metabolite Residues in the Eggs and Edible Tissues of the Laying Hen: Lab
Project Number: TOX/94306: A 56354: TOX/95/142-2. Unpublished study
prepared by AgrEvo UK Ltd. 104 p.
44111800 E.I. du Pont de Nemours and Co. (1996) Submission of Residues in
the Environment Data in Support of FIFRA 6(a)(2) for Numerous Pesticides.
44111801 Johnson, W.; Kroll, R.; Pait, A.; et al. (1996) Data Base of the Occurrence and
Distribution of Pesticides in Chesapeake Bay. Unpublished study retrieved from
Internet at http://www.agnic.org/cbp/. 171 p.
44220400 Riverside/Terra Corp. (1997) Submission of Toxicity Data in Support
of the Registration for Thirethrin.
203
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
44220401 Wnorowski, G. (1997) Acute Oral Toxicity Defined LD50 (Rats): Thirethrin:
Lab Project Number: 4908: P320. Unpublished study prepared by Product Safety
Labs. 27 p.
44220403 Wnorowski, G. (1997) Acute Inhalation Toxicity Test (Rats): Thirethrin: Lab
Project Number: 4913: P330. Unpublished study prepared by Product Safety
Labs. 36 p.
44220404 Wnorowski, G. (1997) Primary Eye Irritation (Rabbits): Thirethrin: Lab Project
Number: 4910: P324. Unpublished study prepared by Product Safety Labs. 21 p.
44220405 Wnorowski, G. (1997) Primary Skin Irritation (Rabbits): Thirethrin: Lab Project
Number: 4911: P326. Unpublished study prepared by Product Safety Labs. 16 p.
44220406 Wnorowski, G. (1997) Dermal Sensitization Test—Buehler Method
(Guinea Pigs): Thirethrin: Lab Project Number: 4912: P328.
Unpublished study prepared by Product Safety Labs. 23 p.
44259701 Brennan, J. (1997) Product Chemistry for Thirethrin.
Unpublished study prepared by Terra International, Inc. 6 p.
44346900 Endosulfan Task Force (1997) Submission of Residue and Environmental Fate
Data in Support of the Reregi strati on of Endosulfan.
44346901 Singer, S.; Chen, W. (1997) (Carbon-14) Endosulfan Sulfate and Diol; Two Soil
Degradates of Endosulfan: Adsorption/Desorption in Four Soil Types: Lab
Project Number: 506BJ: A919/U022: ENDOSULFAN/A55833. Unpublished
study prepared by AgrEvo USA Co. 68 p.
44346902 Huff, K.; Winkler, D. (1997) Validation of the Analytical Method for the
Determination of Endosulfan (alpha, beta and Sulfate) in/on Raw Agricultural
Commodities (RAC) and Processed Commodities (PC): Final Report: Lab Project
Number: 95-0043: BJ-95R-13: A57704. Unpublished study prepared by
EN-CAS Analytical Labs. 208 p.
204
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
44346903 Brady, S. (1997) Magnitude of Endosulfan Residues in or on Cantaloupes
Resulting from Three Applications of Phaser EC or Phaser WP Insecticide, USA,
1995: Lab Project Number: BJ-95R-05: ENDOSULFAN/A55818:
BJ-95R-05-JRS-01. Unpublished study prepared by AgrEvo USA Co. 90 p.
44346904 Brady, S. (1997) Magnitude of Endosulfan Residues in or on Head and Leaf
Lettuce Resulting from Three Applications of Phaser Insecticide, USA, 1995: Lab
Project Number: ENDOSULFAN/A55802: BJ-95R-02: CA-011. Unpublished
study prepared by AgrEvo USA Co. 190 p.
44346905 Brady, S. (1997) Magnitude of Endosulfan Residues in or on Tomatoes Resulting
from Three Applications of Phaser EC or Phaser WP Insecticide, USA, 1995: Lab
Project Number: ENDOSULFAN/A55822: BJ-95R-06: CA-014. Unpublished
study prepared by AgrEvo USA Co. 138 p.
44346906 Brady, S. (1997) Magnitude of Endosulfan Residues in or on Celery Resulting
from a Single Application of Phaser EC or Phaser WP Insecticide, USA, 1995:
Lab Project Number: U022/R141C: ENDOSULFAN/A55830: BJ-95R-04.
Unpublished study prepared by AgrEvo USA Co. 115 p.
44346907 Brady, S. (1997) Magnitude of Endosulfan Residues in or on Summer Squash
Resulting from Three Applications of Phaser Insecticide, USA, 1995: Lab Project
Number: R142B/U022: ENDOSULFAN/A57714: R01-01. Unpublished study
prepared by AgrEvo USA Co. 88 p.
44346908 Brady, S. (1997) Magnitude of Endosulfan Residues in or on Broccoli Resulting
from Three Applications of Phaser EC or Phaser WP Insecticide, USA, 1995: Lab
Project Number: BJ-95R-03: BJ95R03: ENDOSULFAN/A55827. Unpublished
study prepared by AgrEvo USA Co. 107 p.
44346909 Brady, S. (1997) Magnitude of Endosulfan Residues in or on Cucumbers
Resulting from Three Applications of Phaser Insecticide: Lab Project Number:
BJ-96R-01: BJ96R01: R02-01. Unpublished study prepared by AgrEvo USA Co.
115 p.
205
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
44346910 Brady, S. (1997) Magnitude of Endosulfan Residues in or on Sweet Cherries
Resulting from One Application of Phaser Insecticide, USA, 1996: Lab Project
Number: BJ-96R-03: BJ96R03: R05-01. Unpublished study prepared by AgrEvo
USA Co. 102 p.
44346911 Brady, S. (1997) Magnitude of Endosulfan Residues in or on Sour Cherries
Resulting from One Application of Phaser Insecticide, USA, 1996: Lab Project
Number: BJ-96R-04: BJ96R04: R01-01. Unpublished study prepared by AgrEvo
USA Co. 106 p.
44346912 Brady, S. (1997) Magnitude of Endosulfan Residues in or on Sweet Potatoes
Resulting from Two to Three Applications of Phaser Insecticide: Lab Project
Number: BJ96R05: BJ-96R-05: ENDOSULFAN/A57719. Unpublished study
prepared by AgrEvo USA Co. 128 p.
44346913 Brady, S. (1997) Magnitude of Endosulfan Residues in or on Potatoes and
Processed Potato Commodities Resulting from Three Applications of Phaser EC
Insecticide at an Exagerrated Rate, USA, 1995: Lab Project Number:
R1612B/U022: BJ95R08: ENDOSULFAN/A57705. Unpublished study
prepared by AgrEvo USA Co. 70 p.
44346914 Brady, S. (1997) Magnitude of Endosulfan Residues in or on Tomatoes and
Processed Tomato Commodities Resulting from Three Applications of Phaser EC
Insecticide at an Exagerrated Rate, USA, 1995: Lab Project Number:
ENDOSULFAN/A57707: BJ-95R-09: BJ95R09. Unpublished study prepared by
AgrEvo USA Co. 73 p.
44346915 Brady, S. (1997) Magnitude of Endosulfan Residues in or on Grapes and
Processed Grapes Commodities Resulting from Two Applications of Phaser EC
Insecticide: Lab Project Number: BJ-95R-07: BJ95R07:
ENDOSULFAN/A55834. Unpublished study prepared by AgrEvo USA Co. 54
P-
44371700 U.S. Environmental Protection Agency (1997) Submission of Toxicity Data for
Organophosphorus Insecticide (Methyl Parathion ...).
206
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
44371715 Rastogi, A.; Kulshrestha, S. (1990) Effect of sublethal
doses of three pesticides on the ovary of a carp minnow rasbora
daniconius. Bull. Environ. Contam. Toxicol. 45:742-747.
44393000 The Endosulfan Task Force. (1997) Submission of Environmental
Fate Data in Support of the Reregistration of Endosulfan.
44393001 Meyer, B.; lull, P. (1997) Uptake of (carbon 14)-Endosulfan Residues in Soil by
Rotational Crops Under Confined Conditions: Lab Project Number: 503BJ:
BJ95E503. Unpublished study prepared by AgrEvo USA Co. Ill p.
44396300 Endosulfan Task Force (1997) Submission of Residue Data in Support
of the Reregistration of Endosulfan. Transmittal of 1 Study.
44396301 Winkler, D. (1997) Freezer Storage Stability of Endosulfan (Alpha, Beta and
Sulphate) on Crop Raw Agricultural Commodities and Processed Commodities:
Final Report: Lab Project Number: 95-0072: BJ-95R-11: A57831. Unpublished
study prepared by EN-CAS Analytical Labs. 424 p.
44403100 Endosulfan Task Force (1997) Submission of Toxicity and Exposure
Data in Support of the Reregistration of Endosulfan.
44403101 Bury, D. (1997) Endosulfan: Substance, Technical; (Code: HOE 002671 00 ZD99
0008): Neurotoxicological Screening in the Male and Female Wistar Rat: Acute
Oral Toxicity: Lab Project Number: 96.0373: 97.0149: A59088. Unpublished
study prepared by Hoechst Marion Roussel. 563 p.
44403102 Singer, S. (1997) Dissipation of Foliar Dislodgeable Residues of Endosulfan
Following Application of Phaser EC and Phaser WP to Melons, Peaches and
Grapes, USA, 1995: Lab Project Number: BJ-95R-01: BJ95R001:
ENDOSULFAN/A57710. Unpublished study by AgrEvo USA Co. 242 p.
44427600 AgrEvo USA Co. (1997) Submission of Residue Data in Support of the
Reregistration of Endosulfan.
207
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
44427601 Huff, D.; Winkler, D. (1997) Validation of the Analytical Method for the
Determination of Endosulfan (alpha, beta and Sulfate) in Animal Tissues, Egg
(White and Yolk) and Dairy Matrices Based Upon FDA Pesticide Analytical
Manual, Volume 1 Multi-Residue Methodology: Lab Project Number: 95-0061:
BJ-95R-14: A57847. Unpublished study prepared by EN-CAS Analytical Labs.
346 p.
44442700 Drexel Chemical Co. (1997) Submission of Toxicology Data in Support
of the Registration of Drexel Endosulfan SEC.
44442701 Seshaiah, A. (1997) Acute Oral Toxicity Study in Rat: Endosulfan 33.7% EC:
Lab Project Number: 1027/JRF/TOX/97: AOR/ENS/44: 1027. Unpublished
study prepared by Jai Research Foundation. 23 p.
44442702 Bakili, R. (1997) Acute Dermal Toxicity (Study) to Rabbit: Endosulfan 33.7%
EC: Lab Project Number: 1026/JRF/TOX/97: ADRAB/ENS/44: 1026.
Unpublished study prepared by Jai Research Foundation. 28 p.
44442703 Seshaiah, A. (1997) Acute Inhalation Toxicity (LC 50) Study in Rat: Endosulfan
33.7% EC: Lab Project Number: 1031/JRF/TOX/97: AIR/ENS/44: 1031.
Unpublished study prepared by Jai Research Foundation. 42 p.
44442704 Bakili, R. (1997) Primary Eye Irritation (Rabbit): Endosulfan
33.7% EC: Lab Project Number: 1028/JRF/TOX/97: AEI/ENS/44:
1028. Unpublished study prepared by Jai Research Foundation. 25 p.
44442705 Bakili, R. (1997) Primary Dermal Irritation (Rabbit): Endosulfan 33.7% EC: Lab
Project Number: 1029/JRF/TOX/97: ADI/ENS/44: 1029. Unpublished study
prepared by Jai Research Foundation. 19 p.
44442706 Sundar, S. (1997) Dermal Sensitization Study-Guinea Pig Maximisation Test:
Endosulfan 33.7% EC: Lab Project Number: 1030/JRF/TOX/97: GPS/ENS 44:
1030. Unpublished study prepared by Jai Research Foundation. 32 p.
208
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
44457000 Interregional Research Project No.4 (1997) Submission of Residue
Data in Support of the Reregi strati on of Endosulfan.
44457001 Samoil, K. (1997) Magnitude of Residue: Endosulfan on Sweet Corn: Lab Project
Number: 06074. Unpublished study prepared by Univ. of California, Univ. of
Florida and Agric. Consulting, Inc. 596 p.
44560700 AgrEvo USA Company (1998) Submission of Toxicity Data in
Support of the Reregi strati on of Endosulfan.
44560701 Bury, D. (1995) Carbaryl: Neurotoxicological Screening in Rats Positive Study
Control: Lab Project Number: 94.0005. Unpublished study prepared by Hoechst
Aktiengesellschaft. 24 p.
44560702 Bury, D. (1995) Acrylamide: Neurotoxicological Screening in Rats Positive
Control Study: Lab Project Number: 94.0004. Unpublished study prepared by
Hoechst Aktiengesellschaft. 144 p.
44599600 Endosulfan Task Force(1998) Submission of Residue Chemistry Data in Support
of the Reregi stration of Endosulfan. Transmittal of 1 Study.
44599601 Winkler, D. (1998) Freezer storage Stability of Endosulfan (alpha, beta, and
Sulfate) on Animal Tissue and Dairy Matrices: Lab Project Number: 96-0046:
BJ-96R-06: A67512. Unpublished study prepared by EN-CAS Analytical
Laboratories. 237 p. (OPPTS 830.1380}
44617400 FMC Corporation (1998) Submission of Residue Chemistry Data in Support of
the Reregi strati on of Endosulfan Containing Product Thiodan 3 EC Insecticide.
44617401 Jackson, M. (1997) Determine the Magnitude of Residues of Thiodan 3EC in
Pineapple: Lab Project Number: PGAAH950001: THD9501: THD9502.
Unpublished study prepared by Hawaii Agriculture Research Center. 125 p.
44617402 Jackson, M. (1997) Determine the Magnitude of Residues of Thiodan 3EC in
Pineapple Processing Fractions: Lab Project Number: PGAH950001P:
209
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
THD9507P: THD9508P. Unpublished study prepared by Hawaii Agriculture
Research Center. 80 p.
44637800 AgrEvo USA Company (1998) Submission of Residue Chemistry Data in Support
of Reregi strati on of Endosulfan.
44637801 Winkler, D. (1998) Freezer Storage Stability of Endosulfan (Alpha, Beta and
Sulfate) on Crop Raw Agriculture Commodities and Processed Commodities
Amendment No. 1 to Final Report: Lab Project Number: 95-0072: BJ-95R-11.
Unpublished study prepared by EN-CAS Analytical Laboratories. 84 p.
44701200 Endosulfan Task Force (1998) Submission of Residue Chemistry Data in Support
of the Reregi strati on of the Endosulfan Containing Product Phaser Insecticide.
44701201 Brady, S. (1998) Magnitude of Endosulfan Residues in or on Celery Resulting
from a Single Application of Phaser Insecticide, USA, 1997: Lab Project Number:
BJ-97R-02: C000900: XEN98-20. Unpublished study prepared by AgrEvo USA
Company. 64 p.
44701202 Brady, S. (1998) Magnitude of Endosulfan Residues in or on Leaf Lettuce
Resulting from Two Applications of Phaser Insecticide, USA, 1997: Lab Project
Number: XEN98-19: 97-277M: R10-01. Unpublished study prepared by AgrEvo
US A Company. 81 p.
44746400 Drexel Chemical Company (1999) Submission of Product Chemistry Data in
Support of the Registration of Endosulfan 3 EC.
44746401 Handy, R.; West, M.; Kovacs, M. (1997) Physical and Chemical Characteristics
of Drexel Endosulfan 3EC: Lab Project Number: DREX0295. Unpublished
study prepared by Drexel Chemical Company. 9 p.
44762901 Brady, S. (1999) Magnitude of Endosulfan Residues in or on Wheat Grain and
Processed Commodities Resulting from Two Applications of Phaser Insecticide at
an Exaggerated Rate USA, 1998: Lab Project Number: BJ98R001: C000915:
R02-01. Unpublished study prepared by AgrEvo USA Company. 91 p.
210
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
44843700 Endosulfan Task Force (1999) Submission of Residue Chemistry Data
in Support of the Reregi strati on of Endosulfan.
44843701 Gaston, C. (1999) Endosulfan: Chronic Dietary Exposure Assessment: Lab
Project Number: ENDOSULFAN-99-CA02: C002871. Unpublished study
prepared by Novigen Sciences, Inc. 72 p.
44843702 Peatman, M.; Reynolds, C.; Bright, J. et al. (1999) Residues of Alpha-endosulfan,
Beta-endosulfan and Endosulfan Sulfate in Milk amd Edible Cattle Tissues
Following 28 Days Feeding to Lactating Cows Endosulfan Technical Product:
Lab Project Number: 205/05/001: C003624: RESID/99/B. Unpublished study
prepared by AgrEvo UK Limited. 173 p. (OPPTS 860.1480}
44854100 FMC Corporation (1999) Submission of Residue Chemistry Data in
Support of the Registration of Thiodan EC Insecticide.
44854101 Brooks, M. (1996) Magnitude of the Residue of Endosulfan and Endosulfan
Sulfate in/on Cotton Treated with Thiodan 3 EC: Lab Project Number:
323COT95R2: P-3147. Unpublished study prepared by EPL Bio-Analytical
Services. 92 p.
44854102 McChesney, M. (1997) Magnitude of the Residue of Endosulfan and Endosulfan
Sulfate in/on Cotton Treated with Thiodan 3 EC: Lab Project Number:
323COT96R2: RAN-0298. Unpublished study prepared by FMC Corporation.
92 p. {OPPTS 860.1500}
44854103 Kuan, R. (1997) Magnitude of the Residue of Endosulfan and Endosulfan Sulfate
in/on Processed Parts of Cottonseed from Cotton Treated with Thiodan 3 EC: Lab
Project Number: 323COT96R3: RAN-0300. Unpublished study prepared by
FMC Corporation. 103 p.
44863700 AgrEvo USA Company (1999) Submission of Toxicity Data in Support of
the Reregi strati on of Endosulfan.
211
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
44863701 Noctor, J. (1995) (Carbon-14)-Endosulfan: Rates of Penetration Through Human
and Rat Skin Determined Using an in Vitro System: Final Report: Lab Project
Number: 169/54-1011: A54103: P7353D. Unpublished study prepared by
Hoechst Aktiengesellschaft. 116 p.
44903600 Endosulfan Task Force (1999) Submission of Environmental Fate Data
in Support of the Reregi strati on of Endosulfan.
44903601 Fischer, R.; Chen, W.; Coody, P. (1999) Endosulfan: Evaluation of the Runoff
Potential: Lab Project Number: BJ94R002: A67519: BJ98W510. Unpublished
study prepared by AgrEvo USA Company. 649 p.
44917800 Endosulfan Task Force (1999) Submission of Environmental Fate Data in Support
of the Reregi strati on of Endosulfan.
44917801 Gildemister, H. (1985) Hoe 002671--(carbon 14) (Endosulfan): Aerobic Aquatic
Metabolism Study with the Insecticide Endosulfan: Lab Project Number:
(B) 106/85: A31182. Unpublished study prepared by Hoechst Analytisches
Laboratorium. 35 p.
44917802 Stumpf, K. (1990) Endosulfan: Summary Comments Regarding the
Bioavailability in Water/Sediment Systems and Potential Degradability in Water:
Lab Project Number: A44231: A45100: A31128. Unpublished study prepared by
Hoechst Schering AgrEvo GmbH. 20 p.
44933000 AgrEvo USA Company (1999) Submission of Risk Assessment, Exposure and
Residue Chemistry Data in Support of the Reregi strati on of Endosulfan.
44933001 Gaston, C. (1999) Endosulfan: Tier 3 Acute Monte Carlo Dietary Exposure
Assessment Using Refined Assumptions of Anticipated Residues in Foods: Lab
Project Number: B002436. Unpublished study prepared by Novigen Sciences,
Inc. 331 p.
212
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
44933002 Krebs, B.; Huth, G.; Junker, H. et al. (1996) Endosulfan: Residue Trials in Apples
to Establish a Maximum Residue Level Determination of Active Substance and
the Metabolite Decline Following Two Applications in Apples and Processing to
Apple Puree and Apple Juice; and the Resulting Residue Data Summary Report
for Pome Fruit: Lab Project Number: C003264: A57131: A55874. Unpublished
study prepared by Hoechst Schering AgrEvo GmbH. 185 p.
44939100 AgrEvo USA Company (1999) Submission of Risk Assessment, Exposure and
Toxicity Data in Support of the Reregi strati on of Endosulfan.
44939101 White, K. (1999) Assessment of Human Exposure from the Application of
Endosulfan: Lab Project Number: C002873: A54103: 169/54-1011. Unpublished
study prepared by Jellinek, Schwartz and Connolly, Inc. 85 p.
44939102 Bremmer, J.; Leist, K. (1998) Endosulfan: Evaluation of Possible Endocrine
Effects in Mammalian Species: Lab Project Number: TOX98/046: C001570.
Unpublished study prepared by Hoechst Schering AgrEvo GmbH. 17 p.
44953100 AgrEvo USA Company (1999) Submission of Risk Assessment, Exposure and
Toxicity Data in Support of the Reregi strati on of Endosulfan.
44953101 Ramanarayanan, T.; Allen, R. (1999) Endosulfan (AE F002671): Selection of
Tier II Surface Water Exposure Assessment Scenarios Using a Geographical
Information System and Natural Resources Databases: Lab Project Number:
512BJ: B002202: BJ99E512. Unpublished study prepared by AgrEvo USA
Company. 61 p.
44953102 Ramanarayanan, T.; Allen, R. (1999) Endosulfan (AE F002671): Tier II Exposure
Assessment; Sensitivity Analysis for PRZM (Ver 3.12), EXAMS (Ver 2.97.5) and
AgDrift (Ver 1.02): Lab Project Number: 513BJ: B002224: BJ99E513.
Unpublished study prepared by AgrEvo USA Company. 54 p.
44953103 Ramanarayanan, T.; Fischer, R.; Allen, R. (1999) Endosulfan (AE F002671):
Tier II Surface Water Exposure Assessment and Comparison to Aquatic Toxicity
213
-------
ENDOSULFAN BIBLIOGRAPHY
MRID
CITATION
End-Points: Lab Project Number: BJ99E514: B002255: WEI622.06-B.
Unpublished study prepared by AgrEvo USA Company. 282 p.
44953104 Fischer, R.; Heusel, R.; Knauf, W. et al. (1995) Endosulfan
(Hoe 002671)-Tier 2 Summary for EC Directive (91/414/EEC)
Registration Requirements: Section 8, Exotoxicological Studies
on the Active Substance (20/4/94). April 25, 1995. Hoechst
Schering AgrEvo GmbH: Lab Project Number. Unpublished study
prepared by Hoechst Schering AgrEvo GmbH. 67 p.
44953105 Allen, R. (1999) Endosulfan: Calculation of Dietary Exposure
via Drinking Water and Comparison to Drinking Water Level of
Concern (DWLOC): Lab Project Number: BJ99E515: B002594.
Unpublished study prepared by AgrEvo USA Company. 10 p.
44972300 Endosulfan Task Force (1999) Submission of Environmental Fate Data in Support
of the Reregi strati on of Endosulfan Containing Product Phaser Insecticide.
44972301 Brady, S. (1999) Magnitude of Endosulfan Residues in or on Rotational Crops
from Two Applications of Phaser Insecticide USA, 1998: Lab Project Number:
BJ98R002: B002616: AE F002671. Unpublished study prepared by AgrEvo USA
Co. 225 p. (OPPTS 860.1900}
214
-------
Appendix E. Generic Data Call-In
Note that a complete Data Call-In (DCI), with all pertinent instructions, will be sent to
registrants under separate cover.
215
-------
Appendix F. Product Specific Data Call-In
Note that a complete Data Call-In (DCI), with all pertinent instructions, will be sent to
registrants under separate cover.
216
-------
Appendix G. EPA'S Batching of Endosulfan Products for Meeting Acute Toxicity Data
Requirements for Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregi strati on of products containing ENDOSULFAN 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. Notwith-standing the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need 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 of 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.
In deciding 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. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
217
-------
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 choosing not to
participate in a batch does not preclude other registrants in the batch from citing his/her studies
and offering to cost share (Option 3) those studies.
Forty-two products were found which contain Endosulfan as the active ingredient. These
products have been placed into eight batches in accordance with the active and inert ingredients
and type of formulation.
Batching Instructions:
Batch 6: EPA Reg. No. 7401-317 may cite data from EPA Reg. No. 70-126 or EPA Reg. No.
3342-94.
Batch 7: EPA Reg. No. 7401-316 cite data from EPA Reg. No. 16-133.
Batch 1
EPA Reg. No.
264-637
279-2306
10163-223
11678-05
19713-319
34704-799
Percent Active Ingredient
96.0%
95.0%
95.0%
95.0%
94.0%
95.0%
Batch 2
EPA Reg. No.
264-656
267-659
279-1380
279-3129
10163-98
10163-130
51036-91
51036-209
66222-02
Percent Active Ingredient
50.0%
50.0%
50.4%
50.0%
50.0%
50.0%
50.8%
50.0%
51.3%
218
-------
Batch 3
EPA Reg. No.
264-638
264-658
5905-418
10163-110
11678-25
19713-399
34704-21
34704-516
Percent Active Ingredient
34.4%
34.4%
33.3%
34.0%
35.6%
34.3%
33.3%
34.0%
Batch 4
EPA Reg. No.
279-2924
51036-92
Percent Active Ingredient
34.0%
34.0%
Batch 5
EPA Reg. No.
70-142
19713-99
Percent Active Ingredient
24.0%
24.6%
Batch 6
EPA Reg. No.
70-126
3342-94
7401-317
Percent Active Ingredient
4.0%
4.0%
4.0%
Batch 7
EPA Reg. No.
16-133
7401-316
Percent Active Ingredient
3.0%
2.0%
No Batch
EPA Reg. No.
16-141
279-3222
802-516
1327-35
1386-338
3342-102
5481-278
5481-296
5481-316
9779-330
Percent Active
9.0%
Endosulfan
Methyl Parathion
9.2%
15.0%
23.8%
10.2%
26.0%
24.0%
Endosulfan
Sevin
Endosulfan
Pyrethrins
Piperoyl Butoxide
Ingredient
3 1 25%
20 88%
1 5%
15%
22 50%
4 75%
0.45%
219
-------
Appendix H. List of Registrants Sent this Data Call-In Notice
Case # and Name
0014 Endosulfan
Chemical # and Name
079401 Hexachloro-1, 5, 5a, 6, 9, 9a - hexahydro - 6, 9 - methano - 2, 4
Company
Number
00254
019713
011678
Company Name
BAYER CROPSCIENCE
DREXEL CHEMICAL
COMPANY
MAKHTESHIM
CHEMICAL WORKS, LTD
C/O MAKHTESHIM-
AGAN OF N. AMERICA,
INC.
Address
2T.W.
ALEXANDER
DRIVE,
P.O. BOX 12014
P.O. BOX 13327
551 FIFTH
AVENUE, SUITE
1100
City & State
RESEARCH
TRIANGLE PARK,
NC
MEMPHIS , TN
NEW YORK, NY
Zip
27709
38113
10176
220
-------
Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO 1 /forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
Print out and complete the forms. (Note: Form numbers that are bolded can be
filled out on your computer then printed.)
The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information'
or 'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams
at (703) 308-5551 or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
Application for Pesticide
Regi strati on/ Amendment
Confidential Statement of Formula
Notice of Supplemental Registration
of Distribution of a Registered
Pesticide Product
Application for an Experimental Use
Permit
Application for/Notification of State
Registration of a Pesticide To Meet a
Special Local Need
Formulator's Exemption Statement
http://www.epa.gov/opprd001/forms/8570-l.pdf.
http://www.epa.gov/opprd001/forms/8570-4.pdf.
http://www.epa.gov/opprd001/forms/8570-5.pdf.
http://www.epa.gov/opprd001/forms/8570-17.pdf.
http://www.epa.gov/opprd001/forms/8570-25.pdf.
http://www. eDa.gov/ODDrd001/forms/8570-27.Ddf.
221
-------
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Certification of Compliance with
Data Gap Procedures
Pesticide Registration Maintenance
Fee Filing
Certification of Attempt to Enter into
an Agreement with other Registrants
for Development of Data
Certification with Respect to
Citations of Data (in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical
Properties (in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR
Notice 98-1)
http://www.epa.aov/opprd001/forms/8570-28.pdf
http://www.epa.gov/opprd001/forms/8570-30.pdf
http://www.epa.gov/opprd001/forms/8570-32.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-
l.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-
l.pdf
Pesticide Registration Kit
www.epa.gov/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection
Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
222
-------
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
B. Biopesticides and Pollution Prevention Division (BPPD) Contacts
C. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the
United States", PB92-221811, available through the National Technical Information
Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently
in the process of updating this booklet to reflect the changes in the registration
program resulting from the passage of the FQPA and the reorganization of the
Office of Pesticide Programs. We anticipate that this publication will become
available during the Fall of 1998.
223
-------
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information Systems. This
service does charge a fee for subscriptions and custom searches. You can contact
NPIRS by telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides. You
can contact NPTN by telephone at (800) 858-7378 or through their Web site:
ace. orst. edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or
amended registration, experimental use permit, or amendment to a petition if the
applicant or petitioner encloses with his submission a stamped, self-addressed
postcard. The postcard must contain the following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the
date of receipt and provide the EPA identifying File Symbol or petition number for
the new submission. The identifying number should be used whenever you contact
the Agency concerning an application for registration, experimental use permit, or
tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are
properly coded and assigned to your company, please include a list of all synonyms,
common and trade names, company experimental codes, and other names which
identify the chemical (including "blind" codes used when a sample was submitted
for testing by commercial or academic facilities). Please provide a CAS number if
one has been assigned.
Documents Associated with this RED
The following documents are part of the Administrative Record for this RED
document and may be included in the EPA's Office of Pesticide Programs Public Docket. Copies
of these documents are not available electronically, but may be obtained by contacting the person
listed on the respective Chemical Status Sheet.
a. Health and Environmental Effects Science Chapters.
b. Detailed Label Usage Information System (LUIS) Report.
224
------- |