SEPA
United States Prevention, Pesticides EPA 738-R-04-006
Environmental Protection and Toxic Substances May 2004
Agency (7508C)
Interim Reregistration
Eligibility Decision (IRED)
Diazinon
XX-2
738R04006
-------
-------
United States Prevention, Pesticides EPA 738-R-O4-OO6
Environmental Protection and Toxic Substances May 2OO4
Agency (75O8W)
x>EPA I.R.E.D. FACTS
Diazinon
Pesticide EPA has assessed the risks of diazinon and reached an Interim
Reregistration Reregistration Reregistration Eligibility Decision (BRED) for this
organophosphate (OP) pesticide. Without mitigation, diazinon poses
unacceptable risks to agricultural workers and to birds and other wildlife
species. To increase protection for workers, birds, and the environment, the
Agency's decision includes provisions to phase out and cancel certain
agricultural crop uses, the granular formulation, and aerial applications;
reduce the amount and frequency of use; and employ engineering controls
and other protective measures. These changes in diazinon use were
developed through discussions with the technical registrants and were
based on extensive stakeholder input
Diazinon has been one of the most widely used insecticides in the U.S.
for household as well as agricultural pest control. A December 2000 agreement
with the technical registrants phased out and cancelled all indoor and outdoor
residential uses in order to reduce risks to children and others.
Diazinon residues in food and drinking water resulting from agricultural
uses do not pose human dietary risks of concern. While residues attributed to
agricultural and residential uses have been detected frequently in surface
waters, previous mitigation measures for residential products should result in
less frequent detections in water. Without further mitigation limiting children's
and others' exposure through food and drinking water, diazinon fits into its own
"risk cup." Even with the recommended mitigation measures, diazinon's worker
and ecological risks still will be above levels of concern, but these risks are
offset by strong benefits of diazinon use in fruit and vegetable production.
EPA's next step is to consider the cumulative effects of the OP
pesticides, which share a common mechanism of toxicity. The interim decision
on diazinon will not be final until the Agency completes a cumulative evaluation
of the OPs. Further risk mitigation may be warranted at that time.
-------
EPA is reviewing the OP pesticides to determine whether they meet
current health and safety standards. Older OPs require decisions about their
eligibility for reregistration under FIFRA. OPs with food, drinking water,
residential, and any other non-occupational exposures must be reassessed to
make sure they meet the new FFDC A safety standard, brought about by the
Food QuaKty Protection Act of 1996 (FQPA).
The IRED concludes EPA's review of diazinon through the OP pilot
public participation process, which increases transparency and maximizes
stakeholder involvement in the Agency's development of risk assessments and
risk management decisions. EPA worked extensively with affected parties to
reach the decisions presented in the Diazinon IRED. During the past several
years, the Agency has exchanged information on diazinon's uses, risks, and
benefits with USDA, other federal and state agencies, registrants, users, the
environmental community, concerned citizens, and others. This significant input
from stakeholders and interested parties helped EPA reach a decision that
diazinon is eligible for reregistration and meets the FQPA safety standard.
Use Profile
Diazinon is registered to control foliage and soil insects and pests of
many fruit, nut, vegetable, and ornamental crops. Diazinon also is used in cattle
eartags. All residential uses have been cancelled.
Approximately 4 million pounds of the active ingredient diazinon arc
used annually on agricultural sites. Use is highest on almonds and stone fruits.
Hearth
Effects
Risks
Residential Risk
Mitigation
Diazinon can cause cholinesterase inhibition in humans; that is, it
can overstimulate the nervous system causing nausea, dizziness,
confusion, and at very high exposures (e.g. accidents or major spills)
respiratory paralysis and death.
Dietary risks fiom exposure to diazinon residues in food and drinking water
do not exceed the Agency's level of concern.
Occupational exposure to diazinon is of concern to EPA for handlers and
applicators of diazinon as well as to workers entering fields after applications.
EPA has identified ecological risks of concern fiom diazinon use, particularly
to birds, mammal^ bees, fish, and aquatic invertebrates.
Known as Spectracide and other trade names, diazinon was
one of the most widely used insecticides in the U.S. for household lawn and
garden pest control (up to 70% of the 13 million pounds used each year),
indoor residential crack and crevice treatments and pet collars (up to 5% of all
use), and agricultural pest control (about 30% of all use). To reduce risks to
-------
Instructions for ginseng, ornamentals, rutabagas, and watercress have been added to the
table.
REIs for endive, ginseng, pineapples, radishes, rutabagas, and watercress have been
added to the table.
All crops being deleted from labels have been placed together on the label.
A section with directions for SLN registrations has been added.
Engineering control precautions have been added for pilots making aerial application of
liquid or wettable powder products to lettuce.
Instructions to "combine all foliar or soil pests and directions for use" have been deleted
to allow for appropriate pest specific rate and timing variations.
If you have questions on the diazinon IRED or any of the revisions listed above, please
contact the Chemical Review Manager, Stephanie Plummer at (703) 305-0076. For questions
about product reregistration and/or the Product Data Call-in that accompanies this document,
please contact Venus Eagle at (703) 308-8045.
Sincerely,
Debra Edwards, Ph.D.
Director
Special Review and Reregistration Division
Attachment
-------
-------
July 31,2002
i
1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the 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 preliminary and revised risk assessments for the organophosphate pesticide
diazinon. The public comment period on the revised risk assessment phase of the reregistration
process is closed. Based on comments received during the public comment period and. additional
data received from the registrant, the Agency revised the human health and environmental effects
risk assessments and made them available to the public on January 31,2001. Additionally, the
Agency held a Technical Briefing on December 5,2000, where the results of the revised human
health and environmental effects risk assessments were presented to the general public. This
Technical Briefing concluded Phase 4 of the OP Public Participation Pilot Process developed by
the Tolerance Reassessment Advisory Committee, and initiated Phase 5 of that process. During
Phase 5, all interested parties were invited to participate and provide comments and suggestions
on ways the Agency might mitigate the estimated risks presented in the revised risk assessments.
This public participation and comment period commenced on January 31,2001, and closed on
April 2,2001.
Based on its review, EPA has identified risk mitigation measures it believes are necessary
to address the human health and environmental risks associated-with the current use of diazinon.
EPA is now publishing its interim decision on the reregistration eligibility of and risk
management decision for the current uses of diazinon and its associated human health and
environmental risks, The reregistration eligibility and tolerance reassessment decisions for
diazinon will be finalized once the cumulative risks for all of the organophosphate pesticides are
considered. The enclosed "Interim Reregistration Eligibility Decision for diazinon," which was
approved on July 31,2002, contains the Agency's decision on the individual chemical diazinon.
A Notice of Availability for this Interim Reregistration Eligibility Decision for diazinon is
being published in the Federal Register. To obtain a copy of the interim 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 interim RED and all supporting documents are available on the Internet. See
http:www.epa.gov/pesticides/op. A 60-day public comment period on the risk management
decision, including the benefits assessments considered in making this decision, will begin with
-------
the publication of the Notice of Availability.
The interim RED is based on the updated technical information found in the diazinon
public docket. The docket not only includes background information and comments on the
Agency's preliminary risk assessments, it also now includes the Agency's revised risk
assessments for diazinon (the Health Effects Division Human Health Risk Assessment revised as
of December 5,2000 and the Environmental Fate and Ecological Risk Assessment revised as of
February 19,2002), and a document summarizing the Agency's Response to Comments. The
Response to Comments document addresses corrections to the preliminary risk assessments
submitted by chemical registrants, as well as responds to comments submitted by the general
public and stakeholders during the comment period on the risk assessment. The docket will also
include comments on the revised risk assessment, and any risk mitigation proposals submitted
during Phase 5. For diazinon, comments on the risk assessment were submitted by Makhteshim-
Agan of North America, Inc., the technical registrant. Comments on mitigation or mitigation
suggestions were submitted by environmental organizations, agricultural extension agents,
various other organizations, and private citizens.
This document and the process used to develop it are the result of a pilot process to
facilitate greater public involvement and participation in the reregistration and/or tolerance
reassessment decisions for these pesticides. 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 on the organophosphate pesticides
and to engage the public in the reregistration and tolerance reassessment processes for these
chemicals. This open process follows the guidance developed by the Tolerance Reassessment
Advisory Committee (TRAC), a large multi-stakeholder advisory body that advised the Agency
on implementing the new provisions of the FQPA. The reregistration and tolerance reassessment
reviews for the organophosphate pesticides are following this new process.
Please note that the diazinon risk assessments and the attached interim RED concern only
this particular organophosphate. This interim RED presents the Agency's conclusions on the
dietary risks posed by exposure to diazinon alone. The Agency has also concluded its
assessment of the ecological and worker risks associated with the use of diazinon. Because the
FQPA directs the Agency to consider available information on the cumulative risk from
substances sharing a common mechanism of toxicity, such as the toxicity expressed by the
organophosphates through a common biochemical interaction with cholinesterase enzyme, the
Agency will consider the cumulative risk posed by the entire organophosphate class of chemicals
after evaluating the risks for the individual organophosphates. The Agency has decided to move
forward with individual assessments and to identify mitigation measures necessary to address
those human health and environmental risks associated with the current uses of diazinon. The
Agency will issue the final tolerance reassessment decision for diazinon and finalize decisions on
reregistration eligibility once the cumulative risks for all of the organophophates are considered.
This document describes further data requirements for this chemical. Note that a complete
Data Call-in (DCI), with all pertinent instructions, will be sent to registrants separately.
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.
In this interim RED, the Agency has determined that diazinon will be eligible for
reregistration provided that all the conditions identified in this document are satisfied, including
implementation of the risk mitigation measures outlined in Section IV of the document. The
Agency believes that current uses of diazinon may pose unreasonable adverse effects to human
health and the environment, and that such effects can be mitigated with the risk mitigation
measures identified in this interim RED. Accordingly, the Agency recommends that registrants
implement these risk mitigation measures on an expedited schedule. Sections IV and V of this
interim RED describe labeling amendments for end-use products necessary to implement these
mitigation measures and data requirements necessary to confirm the Agency's interim decision
set forth in this interim RED. Instructions for registrants on submitting the revised labeling can
be found in Section V of this interim 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 diazinon. 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. At that
time, any affected person(s) may challenge the Agency's action.
If you have questions on this document or the label changes necessary for reregistration,
please contact the Chemical Review Manager, John Hebert at (703) 308-6249. For questions
about product reregistration and/or the Product DCI that accompanies this document, please
contact Mark Perry at (703) 308-8024.
Sincerely,
,ois A. Rossi, Director
Special Review and
Reregistration Division
Attachment
-------
-------
Interim Reregistration Eligibility Decision
for
Diazinon
Case No. (0238)
-------
-------
Diazffion Team
Office of Pesticide Programs:
Heaftfo |?|fiicts Risk Asseggrrjent
DanetteDrew
JohnDoherty
Cathy Eiden
Steve Knizner
TimLeigJiiDn
Deborah Smegal
Environmental];' glfc Risk Assessment
Betsy Behl
James Felkel
R. David Jones
TomSteeger
Use and Usae
Neil Anderson
Angel Chiri
Nikhil Mallampalli
Nicole 7xrn\
Arthur Grabe
ColweU Cook
T J. Wyatt
Alan Halvorson
William Chism
Stephen Smearman
RegistratJon Siq)port
George LaRocca
DanaPilitt
John Hebert
MarkWilhite
Laura Parsons
-------
Glossary of Terms and Abbreviations
AE Acid Equivalent
ai Active Ingredient
AGDCI Agricultural Data Call-In
ai Active Ingredient
aP AD 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 Fonnula
CFR Code of Federal Regulations
CSFn USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-in
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
DRES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium
specific (Le., drinking water) lifetime exposure at which adverse, noncarcinogenic
health effects are not anticipated to occur.
DWLOC Drinking Water Level of Comparison.
EC Emulsfiable 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
F AO 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 Surfece Water Computer Model
GLC Gas Liquid Chrornatography
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
HOT
IR
LD
'50
LEL
LOG
LOD
LOAEL
MATC
MCLG
mg/kg/day
mg/L
MOE
MP
MPI
MRID
NA
N/A
NAWQA
NOEC
NOEL
NOAEL
.NPDES
NR
OP
OPP
OPPTS
Pa
PAD
PADI
PAG
PAM
PCA
POP
Highest Average Field Trial
Highest Dose Tested
Index Reservoir
Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death in 50% of test animals. It is usually expressed
as the weight of substance per weight or volume of water, air or feed, e.g., mgfl,
mg/kgorppm.
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.
Lowest Effect Level
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to
regulate contaminants in drinking water under the Safe Drinking Water Act
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
Not Applicable
Not Applicable
USGS National Water Quality Assessment
No Observable Effect Concentration
No Observed Effect Level
No Observed Adverse Effect Level
National Pollutant Discharge Elimination System
Not Required
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Pascal, the pressure exerted by a force of one newton acting on an area of one
square meter.
Population Adjusted Dose
Provisional Acceptable Daily Intake
Pesticide Assessment Guideline
Pesticide Analytical Method
Percent Crop Area
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 n Surface Water Computer Model
Q, * He Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RAC Raw Agriculture Commodity
RBC RedBloodCeU
RED Reregistrarkin 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 L^yer Clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TC Tc^c 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
USGS United States Geological Survey
UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
rv
-------
I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to November 1,1984.
The amended Act calls for the development and submission of data to support me reregistration 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")- Reregistration involves a thorough review of me 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
*^K> unreasonable adverse effects" criteria of FIFRA.
On August 3,1996, me Food Quality Protection Act of 1996 (FQPA) was signed into law. This
Act amends F1FKA to require tolerance reassessment of all existing tolerances. The Agency had
decided mat, for those chemicals that have tolerances and are undergoing reregistration, the tolerance
reassessment will be initiated through this reregistration 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 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. Diazinon belongs to a group of pesticides called organophosphates,
which share a common mechanism of toxicity - they all affect the nervous system by inhibiting
cholinesterase. Although FQPA significantly affects the Agency's reregistration process, it does not
amend any of the existing reregistration deadlines. Therefore, the Agency is continuing its reregistration
program white it resolves me remaining issues associated wim me implementation of FQPA.
This document presents the Agency's revised human health and ecological risk assessments, its
progress toward tolerance reassessment, and the interim decision on the reregistration eligibility of
diazinon. It is intended to be only me first phase in the reregistratic^ process for diazinon. The Agency
will eventually proceed with its assessment of the cumulative risk of the OP pesticides and issue a final
reregistration eligibility decision for diazinon.
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
cornposed of representatives from mdustry, environmental grou^ The
TRAC identified the following science policy issues it believed were key to the implementation of
FQPA and tolerance reassessment:
Applying the FQPA 10-Fold Safety Factor
* Whether and How to Use "Monte Carlo" Analyses in Dietary Exposure Assessments
How to Interpret "No Detectable Residues" in Dietary Exposure Assessments
Refining Dietary (Food) Exposure Estimates
* Refining Dietary (Drinking Water) Exposure Estimates
1
-------
Assessing Residential Exposure
* Aggregating Exposure from all Non-Occupational Sources
How to Conduct a Cumulative Risk Assessment for Organophosphate or Other Pesticides with
a Common Mechanism of Toxicity
Selection of Appropriate Toxicity Endpoints for Risk Assessments of Organophosphates
Whether and How to Use Data Derived from Human Studies
The process developed by the TRAC calls for EPA to provide one or more documents for
public comment on each of the policy issues described above. Each of these issues is evolving and in a
different stage of refinement Some issue papers have already been published for comment in the
Federal Register and others will be published shortly.
In addition to the policy issues that resulted from the TRAC process, the Agency issued, on
Sept 29,2000, a Pesticide Registration Notice (PR 2000-9) that presents EPA's approach for
managing risks fmm nrgannphnsphate pesticides to occupational users. The Worker PR Notice
describes the Agency's baseline approach to managing risks to handlers and workers who may be
exposed to organophosphate pesticides, and the Agency expects that other types of chemicals will be
handled similarly. Generally, basic protective measures such as closed mixing and loading systems,
enclosed cab equipment, or protective clothing, as well as increased reentry intervals will be necessary
for most uses where current risk assessments indicate a risk and such protective measures are feasible.
The policy also states mat the Agency will assess each pesticide individually, and based upon the risk
assessment, determine the need for specific measures tailored to the potential risks of the chemical.
The measures included in mis interim RED are consistent with the Worker Pesticide Registration
Notice.
This document consists of six sections. Section I contains the regulatory fiamework for
reregistration/tolerance reassessment as well as descriptions of the process developed by TRAC for
public comment on science policy issues for the organophosphate pesticides and the worker risk
management PR notice. Section n provides a profile of the use and usage of the chemical. Section ID
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 interim decision on
reregistration 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 (DO)
information. The revised risk assessments and related addenda are not included in this document, but
are available on fee Agency's web page www.epa.govypesticides/op, and in the Public Docket
-------
II. Chemical Overview
A. Regulatory History
Diazmon was first registered in the United States in 1956 as an oxganophosphate insecticide,
acariride, and nematkdde used on a variety of pests, tor control of soil insects and pests of fruit,
vegetables, and forage and field crops.
B. Chemical Identification
Common Name: Diazinon
Chemical Name:
Chemical family:
Case number:
CAS registry number:
OPP chemical code:
Empirical formula:
Molecular weight:
Trade and other names:
Basic manufacturers:
Vapor pressure:
phosphorothioate
Qrganophosphate
0238
333-41-5
057801
C]2H21N2O3PS
304.3
Spectracide, D.Z.N., Knox-Out, Diazol
Makhteshim-Agan of North America Inc.
Syngenta Crop Protection
1.40xl90%piire)isanarnbertohiownHquidwithaboilh^ Technical diazinon
is not very soluble in water (40 ppm at 20°Q but is completely miscible in acetone, benzene,
dichloromethane, ethanol, 1-octanol, toluene, and xylene, and is soluble in petroleum oils.
-------
Use Profile
The following information is based on the currently registered uses of diazinon:
Type of Pesticide: Insecticide, acaricide, nematicide.
Summary of Use Sites:
Food: almonds, apples, apricots, bananas*, beets (red, table), blackberries, blueberries,
cabbage, carrots, cauliflower, celery*, cherries, collards, sweet com, cranberries,
cucumbers*, endive (escarole), figs, filberts, ginseng, grapes, bops, kale, lettuce,
loganberries, melons, mushrooms, nectarines, onions, paisley*, parsnips*, peaches, pears,
peas*, peppers*, pineapples, plums, Irish potatoes*, prunes, radishes, radishes (Chinese),
raspberries, nrtahagag squash (winter and summer)*, spinach, strawberries, sugar beets,
sweet potatoes*, Swiss chard, tomatoes, turnips (roots and tops)*, vegetables (Brassies
leafy group), walnuts, and watercress.
Crops designated with an (*) appear only on 24(c) Special Local Need
registrations.
Hftier Agricultural sites: seed treatment on beans (except soybeans), field com, sweet com,
lima beans, peas, and snap beans; use on non-lactating cattle as an ear-tag.
Bfi^JdsnJjaJ: All indoor residential product registiatkras, ioduding pet collars will be
canceled and retail sale will end by December 31,2002. All outdoor residential product
registrations will be phased out and canceled by December 31,2004. Outdoor
residential use sites include: outdoor ornamentals, home lawns, window and door screens,
window sills, the house foundation, unenclosed porches (but not underneath porches),
patios, entrance ways, walks, outdoor garbage cans and outdoor garbage can storage
areas, tree trunks, into cracks and other places where insects hide, around the outside of
the house next to the foundation, and use as an additive to paints or stains for application
outside on exterior surfaces of homes. Additionally, as part of the phase out, for all lawn,
garden and turf uses, rnanufecturing amounts will be decreased over time (25 percent
decrease in production for 2002 and 50 percent decrease in production for 2003).
California currently holds a 24(c) Special Local Need registration for soil drenching
around residential citrus trees for control of Mediterranean fruit fry.
Public Health: Diazirm is curoBtfylabded for control of n^
California holds a Section 24(c) registration for the control of plague infected fleas on
squirrels.
Other Nonfood: range, pasture, grasslands, ornamentals, food/feed handling
establishments, and livestock areas.
-------
c. Population Adjusted Dose (PAD)
The PAD is a term that characterizes the dietary risk of a chemical and reflects the Reference
Dose, either acute or chronic, that has been adjusted to account for the FQPA safety factor (i.e.,
RfD/FQPA safety factor). In the case of diazmon, the FQPA safety factor is 1; therefore, the acute or
chronic RfD is equal to the acute or chronic PAD. A risk estimate that is less than 100% of the acute or
chronic PAD does not exceed the Agency's risk concern.
Acute PAD:
Hie acute PAD is the dose an individual could be exposed to on any given day and no adverse
health effects would be expected to occur. A rat acute neurotoxicity study resulted in a NOAEL of
025 mg/kg/day based on plasma cholinesterase inhibition. The uncertainty factors selected were 10X
for intra-species uncertainty and 10X for inter-species uncertainty for a total uncertainty factor (UF) of
100X.
Acute RfD = 0.25 mg/kg/day (NOAEL) * 100 (UF) = 0.0025 mg/kg/day.
Acute PAD = Acute Rft> *- FQPA Safety Factor (1) = 0.0025 mg/kg/day.
Chronic PAD:
A chronic reference dose was derived from the results in toto from seven oral feeding studies (in
dogs from 4 week, 90-day, and 1 year feeding studies, and in rats from a 28-day feeding study, a 90-
day feeding study, a 90-day neurotoxidry study and a 2 year feeding stu^ Results from these studies
demonstrated that the 0.02 mg/kg'day dose level was consistent with a pattern of no adverse effects on
cholinesterase inhibition. The uncertainty factors selected were 10X for intra-species uncertainty and
lOx for inter-species uncertainty for a total uncertainty factor (UF) of 100X.
Chronic RfD = 0.02 mg/kg/day (NOAEL) * 100 (UF) = 0.0002 mg/kg/day.
Chronic PAD = Chronic RfD * FQPA Safety Factor (1) = 0.0002 mg/kg/day.
d. Exposure Assumptions
Revised acute and chronic dietary risk analyses for diazinon were conducted with me Dietary
Exposure Evaluation Model (DEEM). DEEM incorporates consumption data generated in USDA's
Continuing Surveys of Food Intakes by Individuals (CSFE), 1989-92. Tnis analysis is refined in that it
uses monitoring data for USDA's Pesticide Data Program (PDF) and FDA Surveillance Monitoring
Program to calculate anticipated residues for use in me acute dietary analysis. Controlled field trial data
are also used for anticipated residues but monitoring data are preferred because samples are more
reflective of residues that may occur on foods as consumed. Data on percent of a crop-treated were
incorporated for all commodities with diazinon tolerances included in the acute dietary assessment
-------
The PDF program has repented analyses for diazinon per se for almost all commodities up
through 1998. For the 1997 data, out of eleven crops and more than 7,000 samples analyzed, no
detectable diazoxon residues were reported with the exception of one spinach sample. The preliminary
1998-1999 data on five crops show no detectable diazoxon residues in any of the more than 1,400
samples analyzed. There were no reports of detectable residues of the metabolites of diazinon for
1992-1998 m either domestic or imported foods. The preponderance of residue data from metabolism
studies, residue field trial and monitoring data indicated that the metabolites, diazoxon and hydroxy
diazinon, are infrequenuy to never detected for fee majority of crops. Therefore, these metabolites are
not included in the dietary assessment
In the acute dietary assessment, exposure was compared to the acute Population Adjusted
Dose(aPAD) based on the acute reference dose (RfD)and a IX FQPASafety Factor, in the chronic
dietary assessment, exposure was compared to the chronic PAD based on the chronic RfD and a IX
FQPA Safety Factor. The Agency considers dietary residue contributions greater than 100% of the
PAD to be of concern.
e. Food Risk Characterization
Generally, a dietary risk estimate that is less than 100% of the acute or chronic PAD is not of
concern. The acute dietary risk from dia/mnn residues on food is below the Agency's level of concern;
that is, less than 100% of the acute PAD is utilized. For the most exposed subgroup, children (1-6
years), the percent acute PAD value is 63 at the 99.9th percentile of exposure. The chronic dietary risk
from food alone is not of concern. For the most exposed subgroup, children (1 to 6 years old), the
percent chronic PAD value is 22.
Refinements to the dietary analyses can be made using monitoring data for the chronic dietary
analysis, and a probabilistic assessment for acute dietary analysis. Refinements will be conducted when
cumulative risks for all of the organophosphates are considered.
2. Dietary Risk from Drinking Water
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.
The GENEEC and PRZM-EXAMS models were used to estimate surface water concentrations,
and SC1-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.
Ground water monitoring studies were also used to estimate concentrations.
Environmental fate data indicate that diazinon and its degradates may occur in both ground water
and surface waters to varying degrees. Therefore, consideration is being given to the probability of
residues and toxicologicaUy significant metabolites of diazinon appearmg in ground water. Diazinon is
only moderately mobile and persistent laboratory data indicate that diazinon will not persist in acidic
10
-------
water, however, in neutral and alkaline waters, residues may be quite persistent Oxypyrimidine is the
main soil and water degradate. Diazoxon, a toxic degradate, was not found in laboratory fate studies
but was found in the field dissipation studies. Modeling and monitoring data tor drinking water do not
consider diazinon degradates. There is evidence that degradates may be formed by water treatment
such as chlorination. The toxicity of these degradates is uncertain.
a. Surface Water
The Tier n PRZM-EXAMS screening model is used to estimate the upper-bound concentrations
in drinking water derived from surface water. Model estimates from a scenario representing diazinon
use on peaches using the index reservoir was selected for use in the human health risk assessment as it
represented a high end use pattern. A maximum diazinon concentration of 70 ug/L, and a 90th
percentile (i.e. 1 in 10 year) annual diazinon concentration of 9.4 ug^L were recommended for use in
acute and chronic risk assessments, respectively.
Diazinon was the most frequently detected insecticide in surface water monitoring studies
conducted by the United States Geological Survey under the National Water Quality Assessment
Program (NAWQA) and Stream Quality Network programs, California state regulatory agencies, and
other sources. It is detected more frequently and at higher concentrations m samples from urban sites
than at agricultural sites. Surface waters sampled include rivers, streams, and creeks from areas with
both agricultural and urban pesticide use. For example, diazinon was detected frequently (35% of
NAWQA samples) at concentrations ranging from below the level of quantitation up to 3.8 ug/L.
b. Ground Water
Results from a variety of ground water monitoring studies that include diazinon as an analyte were
used. No metabolites were included in the analyses. In general, diazinon has been detected in
groundwater from a variety of sources, drinking water wells, monitoring wells, and agricultural wells.
Many of the studies conducted have been located in areas where pesticide use and agricultural
production are considered to be high. The concentrations of diazinon detected in ground water (all
wells) ranged from non-detectable (ND) to 1.0 ug/L.
Much of the ground water data provided comes from the United States Geological Survey
National Water Quality Assessment Program (NAWQA), which assesses ambient water quality.
Approximately 2% of the ground water samples collected through this program from 1992 to 19% had
positive detections of diazinon. However, the maximum concentration value was below the limit of
quantitation for all wells sampled, and the median value was ND or O.002 ug(L. Results from the
NAWQA database indicate that diazinon was detected more frequently in shallow ground water in
urban areas than in agricultural areas.
The relative percentage of samples with detections to total wells sampled from studies in which
rural drinking water wells were sampled ranged from 5 to 22.5%. The maximum concentration
detected in the rural drinking water wells sampled was 1.0 ug/L, and the 95th percentile concentration
11
-------
values ranged from ND to <0.3 ug/L. Average (mean) concentrations as determined from all samples
analyzed were reported to range from 0.012 to <03 ug/L. Since most wells were sampled one time
only, an average concentration value for diazmon per well is not available.
The SCI-GROW model was used to provide a 90-day average concentration of 0.8 ug/L as an
upper bound estimate of diazmon concentrations in shallow ground water.
c. Drinking Water Levels of Comparison (DWLOCs)
To determine the maximum allowable contribution of water-containing pesticide residues
permitted in the diet, EPA 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 whemer modeled or monitoring levels exceed mis 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
exposure, does not exceed a level of concern.
The results of the Agency's drinking water analysis are smnmarigBd here. Details of this analysis,
which used screening models and actual monitoring data, are found in the HED Human Health Risk
Assessment, dated December 5,2000.
For acute risk, the potential drinking water exposure derived from ground water is not of
concern for all populations. Although the acute DWLOC is exceeded for all reported populations for
surface water, the Agency has determined mat these exceedances are probably not of concern. The
PRZM-EXAMS model mat is used to estimate diazmon concentrations is a Tier II model and a
screening-level assessment TTie results of the model are expected to be higher than the diazmon
concentrations actually found in drinking water; in other words, these are likely an overestimate of
residues. There are several sources of conservatism built into the model estimates. In particular, the
site chosen to represent a particular crop is chosen because it is expected to produce concentrations
greater than 90% of the sites used for that crop. The value represents a concentration that was equaled
or exceeded only once every 10 years in the model simulation. The use rate used in the simulation was
the maximum label rate for that crop. Both groundwater and surface water monitoring data supportthe
conclusion mat drinking water residues win likely be lower than the modeled concentrations. The table
below presents the calculations for the acute drinking water assessment
Table 3. Summary of DWLOC Calculations for Acute Risk
Subgroup
U.S. Population
0.0025
0.00067
0.0018
0.8
70
55
Females 13-50 yrs
Children 1-6 yrs
0.0025
0.0025
0.00060
0.00119
0.0019
0.0013
0.8
0.8
70
70
48
12
-------
For chronic risk, potential exposure to drinking water derived from groundwater is not of
concern for all populations.
For me same reasons the acute drinking water risk exceedances arc not of concern, the Agency
has determined that diaztnon's chronic drinking water risk estimate is nc* of ooncen^ even though the
DWLOC is exceeded for all populations.
Table 4. Summary of DWLOC Calculations for Chronic Risk
U.S. Population
0.0002
0.000028
0.00017
0.8
Females 13 - 50 yrs
0.0002
0.000024
0.00018
0.8
Children 1-6 yrs
0.0002
0.000045
0.00016
0.8
3. Occupational and Residential Risk
Occupational workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. Residents or homeowners can be exposed to a pesticide through
mixing, loading, or applying a pesticide, or through entering or performing other activities on treated
areas. Occupational handlers of diazinon include: individual farmers or growers who mix, load, and/or
apply pesticides, professional or custom agricultural applicators, and lawncare and turf management
professionals. It should be noted that indoor, residential use products are being phased out and
cancelled and cannot be sold after December 31,2002. Outdoor lawn and garden diazinon products
are being phased out and cancelled and cannot be sold after December 31,2004. Therefore, only
agricultural occupational risk is discussed in mis IRED. For infonnation on residential risk, consult the
HED risk assessment
Risk for all of these potentially exposed populations is measured by a Margin of Exposure
(MOE), which determines how close the occupational or residential exposure comes to a No
Observed Adverse Effect Level (NOAEL). Generally, MOEs greater than 100 do not exceed the
Agency's risk concern.
a. Toxicity
The toxicity of diazinon is integral to assessing the occupational risk. All risk calculations are
based on the most current toxicity infonnation available for diazinon, including a 21-day dermal toxicity
study. The toxicological endpoints, and other factors used in the occupational and residential risk
assessments for diazinon are listed below. Because route specific toxicity studies are available, dermal
and inhalation adsorption factors are not necessary.
13
-------
Table SB. Summary of lexicological Endpoints and Other Factors Used in the Human
Occupational Assessments for Diazinon.
Short-term dermal
[MOE > 100)
intermediate- term dennal
[MOE > 300)*
Short-term, intermediate
ind long-term inhalation
[MOE > 300)**
SOAEL=1
ng/kg/day
LOAEL = 5 mg/kg/day
*OAEL=1
ng/kg/day
-OAEL - 5 mg/kg/day
LOAEL=0.lDg/t
[0.026 mg/kg/day)
significant serum and brain
cholinesterase inhibition at 5
ng/kg/day
significant serum and brain
:holinesterase inhibition at 5
ng/kg/day
significant serum and RBC
;holinesterase inhibition at
).026 mg/kg/day
21 day dermal (rabbit)
MRID 40660807
21 day dermal (rabbit)
MRID 40660807
2 1 day whole body rat
inhalation study (6 hours/day)
MRID 40815002
* Target MOE is 300 since the length of the study may not be adequate to address the concern for achieving a
steady state following longer exposure.
** Target MOE is 300 because a NOAEL was not established for cholinesterase inhibition, and additional 3X factor
is required for inhalation exposure risk assessments.
Diazinon has moderate acute toxicity and is classified as Category m for all routes of exposure.
It is not a skin sensitizer. Table 5b summarizes the acute toxicity of the active ingredient
Table 5b. Acute Toxicity Profile for Occupational Exposure for diazinon.
Oral
Dermal
Inhalation
Eye Irritation
[>ermal Irritation
Dennal Sensitizer
LDW= 1340 mg/kg - male rat; 11 60 mg/kg -female rat; combined sex =
1250 mg/kg; 95% confidence limit (MRID 41407218)
IDs, > 2020 mg/kg (MRID 41407219); rabbit
LCso > 233 mg/L/4 hours (MRID 41407220); rat
Minimally irritating (MRJD41407221); rabbit
Maximum irritation score = 2.8; slight irritant (MRID 41407222); rabbit
Buehler assay; not a sensitizer (MRID 4 1407223); guinea pig.
m
m
m
m
m
Negative
b. Exposure
A chemical specific applicator study was used to evaluate the application of a 2% diazinon dust
formulation by a pest control operator indoors (MRID 44348801). All indoor uses have been
canceled; therefore this study's results ate not relevant for the occupational exposure assessment results
presented below. No other chemical-specific occupational mixer/loader/applicator data were available
for supporting the reregistration of diazinon. However, seed treatment data from a lindane seed
treatment study (dust formulation, MRID 44405802) were used for screening level assessment of the
diazinon seed treatment scenario.
14
-------
Analyses were also performed for short and intermediate term exposures using the Pesticide
Handlers Exposure Database (PHED) Version 1.1. Standard assumptions about average body
weight, work day, daily areas treated, volume of pesticide used, etc., were used to calculate risk
estimates. Hie quality of the data and exposure factors represents the best sources of data currently
available to the Agency for completing these kinds of assessments; the application rates (in most cases
the maximum rate was used) and the amount applied in a single day are derived directly from diazinon
labels. The exposure factors (e.g., body weight, amount treated per day, protection factors, etc.) are
all standard values mat have been used by me Agency over several years, and the PHED unit exposure
values are the best available estimates of exposure. Some PHED unit exposure values are high quality,
while others represent low quality, but arc the best available data. The quality of the data used for each
scenario assessed is discussed in the Human Health Assessment document tec diazinon, which is
available in the public docket
Anticipated use patterns and application methods, range of application rates, and daily amount
treated were derived from current labeling. Application rates specified on diazinon labels range from
0.5 to 4 pounds of active ingredient per acre m agricultural settings. The Agency typically uses''acres
treated per day** values mat are thought to represent eight solid hours of application work for specific
types of application equipment
Occupational handler exposure assessments are conducted by the Agericy using different levels
of personal protection. The Agency typically evaluates all exposures with minirnal protection and then
adds additional protective measures, using a tiered approach, to obtain an appropriate MOE (i.e.,
goir^trcm minimal to maximum levels of protection). The lowest suite of 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 (EC) are applied. In some cases, EPA will conduct
an assessment using PPE or ECs taken from a current label. The levels of protection that formed the
basis for calculations of exposure from diazinon activities include:
Baseline:
Minimum PPE:
Long-sleeved shirt and long pants, shoes and socks.
Baseline + chemical resistant gloves and a respirator if risk is driven by
inhalation.
Maximum PPE:
Engineering controls:
Coveralls over long-sleeved shirt and long pants, chemical resistant
gloves, chemical footwear plus socks, chemical resistant headgear for
overhead exposures, and a respirator if risk is driven by inhalation.
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 a packaged based system
(e.g., Lock N Load for granulars or water soluble packaging for
15
-------
wettable powders). Some engineering controls are not applicable for
certain scenarios (e.g., for handheld application methods there are no
known devices that can be used to routinely lower the exposures).For
the purpose of this risk assessment, the Agency has determined mat
the frequency and duration of diazinon uses by occupational handlers
result in short-term (1- 30 days) and intermediate term (30 - 180
days) exposures. The Agency believes that no uses of diazinon would
result in chronic exposures (more than 180 days).
Finally, post application exposure to workers through entry into agricultural fields treated with
diazinon were also considered These activities result in potential short-tarn and intermediate-term
dermal diazinon post application exposures. Two dislodgeable foliar residue (DFR) studies submitted
by the registrant that address the dissipation of diazinon on cabbage and broccoli (MRID 40202902)
and citrus (40466601). Thesestudies were used to evaluate pc*enn^pc^appli
-------
intraspecies (10X) factors, in addition to a 3X to extrapolate from a 21 day dermal study to longer term
exposures. For inhalation risk assessments (all time periods) the target MOE is 300 resulting from the
interspecies (10X) and intraspecies (10X) factors, and for lack of a NOAEL in the critical study and
consequent use of a LOAEL (3X). MOEs below the target level would represent a risk concern.
Dermal and inhalation exposures were combined because of a common toxiciry endpoint (i.e.,
cholinesterase inhibition), and because An
aggregate risk index (ARI) was used to combine short term dermal and inhalation risk estimates
because the dermal and inhalation target MOEs are different (i.e., 100 for dermal and 300 for
inhalation). An ARI of less than 1 exceeds HED's level of concern. However, a total MOE was
calculated for intermediate and long-term exposures because the target MOE is 300 for both dermal
and inhalation exposure. For intermediate and long term aggregate exposure, an MOE of 300 is the
target MOE.
As described in the January 15,2002, memorandum HED's Development of Handler Risks for
the Diazinon Risk Benefit Analysis, modifications have been made to the exposure factors affecting the
MOEs presented in Table 6. Modifications include the ratio of the dermal surrace area to body weight,
as well as the changes to the inhalation rates. The ratio of the body surrace area to the body weight
used in dermal calculations to estimate potential dose overestimates exposure by a factor of 1.1. The
ratio is not physiologically matched in that the surface area used in the calculations is for an average
rnale wMe oie body weight is the median for both rnale/fernale. The inhalation exposure is modified by
the adaptation of NAFTA recommended values for breaming rates. NAFTA reccarirnends inhalation
rates of 8.3,16.7, and 26.7 L&nin for sedentary activities (e.g., driving a tractor), light activities (e.g.,
Saggers and mixers/loaders < 50 Ib containers), and moderate activities (e.g., loading > 50 Ib
containers, handheld equipment in hilly conditions), respectively. These inhalation reduction factors
reduce the estimated dose and increase corresponding MOEs by factors of 3.5 for tractor drivers, 1.7
for mixer/loaders and flaggers, and 1.1 for handheld equipment A complete copy of this document can
be found in the public docket
Only three of the short term scenarios evaluated using engineering controls have acceptable ARIs
(i.e., > 1) for mixers/loaders: loading granulars for tractor-drawn spreaders at 1.00 Ib ai/acre and 3.00
Ib ai/acre with ARIs of 3.56 and 1.17 respectively and sprays (liquid formulation) for groundboom
application at 0.50 Ib ai/acre with an ARI of 129. For applicators, only one short term scenario had an
acceptable ARI: applying liquid formulations by groundboom at 0.50 Ib ai/acre with an ARI of 2.97.
ARIs for all other scenarios for mixers/loaders and applicators ranged from 0.02 to 0.70 and 0.05 to
0.59 respectively.
(1) Agricultural Handler Risk
EPA has determined mat there are potential exposures to mixers, loaders, applicators, or other
handlers during usual use patterns associated with diazinon. The Occupational and Residential
Exposure Assessment and Recommendations for the RED Document for Diazinon dated November
17
-------
30,2000, includes 32 major occupational and exposure scenarios (including agricultural animal
premise, green house, and/or commercial handler exposures). For purposes of this IRED discussion,
we are focusing on currently registered use patterns. Based on current use patterns and potential
exposures, these major occupational exposure scenarios for agricultural uses are identified to represent
the extent of diazinon uses.
(1) MixingOoading liquids to support
(a) aerial applications;
(b) groundboom applications;
(c) airblast applications.
(2) Mixing/loading wettable powders to support:
(a) aerial applications;
(b) groundboom applications;
(c) airblast applications;
(3) Loading granules to support tractor-drawn broadcast spreaders applications.
(4) Applying sprays or liquids with:
(a) an airblast;
(b) a groundboom;
(c) aerial equipment
(5) Applying granules with a tractor drawn spreader
Tlie results of the short term handler assessments are simrnarized in Table 6 below. Shaded
boxes indicate acceptable MOEs. Only the short term (less than 30 days) handler assessment was
used to detenm^ appiupuate occupational handler risk mitigation. Although information is not
available to determine what percentage of applicators apply diazinon continuously for more than 30
days, it is reasonable to believe that those individuals will represent a very small segment of agricultural
applicators. The intermediate term handler assessment can be found in the Occupational and Residential
Exposure Assessment and Roxmmendations tor the RED Document for Diazinon. No chronic
exposure durations (more than 180 days per year) for agriciiftural handlers have been identified. All
risk estimates using baseline and PPE were unacceptable; therefore, onfy the scenarios with engineering
controls are presented.
18
-------
Table 6. Agricultural Uses: Remaining Risk Concerns (combined dermal & innalation
MOEs) with Engineering Controls.
Mmonds
3.00
350
aerial / liquid
0.042
0.052
8.6/14.3
J5.7/87.5
40
airblast / liquid
0.43
0.082
74.8 / 34.1
119
3SO
aerial / WP
0,026
0.052
7.48/14.3
12.24/87.5
40
airblast / WP
0.23
0.082
66/34.1
107.1/119
Apples
Pears
2.00
350
aerial / WP
0.040
0.15
11/22
18.7/133
40
airblast / WP
0.35
0.27
97.9/50.6
161.5/178.5
Apricots
Nectarines
Peaches
Plums
Prunes
Walnuts
2.00
350
aerial / liquid
0.075
0.15
13.2/22
52.7/38
40
airblast / liquid
0.64
0.27
i/50.6
\l 178.5
350
aerial/WP
0.040
0.15
11/22
18.7 / 38
40
airblast/WP
0.35
0.27
?7.9/50.6
161.5/178.5
Beets (red)
Onions
Spinach
350
aerial / liquid
0.30
0.59
51.7/88
80
groundboom / liquid
350
aerial / WP
0.16
0.59
45.1 / 88
73.1 /!
80
groundboom / WP
0.70
80
tractor-drawn spreader/
granular
0.90
0.24
289/91
Blackberries
Boysenberries
Dewberries
Loganberries
Raspberries
Cherries (sweet)
2.00
350
aerial / liquid
0.075
0.15
13.2 / 22
52.7/133
40
airblast / liquid
0.64
0.12
S/50.6
1/178.5
350
aerial/WP
0.040
0.15
11/22
18.7/133
40
airblast/WP
0.35
0.12
97.9/50.6
161.5/178.5
Blueberries
Grapes
Hops
1.00
350
aerial / liquid
0.15
0.29
25.3/44
107.1 /126.6
40
airblast / liquid
0.54
350
aerial / WP
0.080
0.29
22/44
37.4/126.6
40
airblast / WP
0.70
0.54
Jroccoli
Brussels Sprouts
Oabbage
.5
350
aerial / liquid
0.30
0.59
51.7/88
221/1
80
groundboom / liquid
350
aerial / WP
0.16
0.59
45.1/88
73.1 /
80
groundboom / WP
0.70
80
tractor drawn
spreader / granular
0.32
1/119
19
-------
si
n j
(&tii& s^l&oi&i
1 si !
I HI
Cantaloupes
Crenshaw
Melons
Endive
iloneydew
Melons
riuskmelons
'ersian Melons
Watermelon
Carrots
Cauliflower
Collards
Cale
Radishes
lutabagas
Tomatoes
Corn (sweet)
Cranberries
3inseng
.ettuce
II1H
1
4
4
4
4
5
4
4
3
JS
4
0.50
4.0
1.00
*£&%& '
iafcJS^ *
$S
-------
Viustard greens
4.00
350
aerial / liquid
0.037
0.074
638/11
27.2/66.5
80
groundboom / liquid
0.16
0.37
27.5/48.4
117.3 /
350
aerial/WP
0.020
0.074
5.61/11
9.18/66.5
80
groundboom / WP
0.087
0.37
24.2/48.4
40.8/455
1.00
80
tractor drawn
spreader / granulars
0.90
'289
Pineapples
2.00
350
aerial / liquid
0.075
0.15
13.2/22
52.7/133
40
airblast / liquid
0.64
0.27
I/S0.6
178.5
1.00
350
aerial/WP
0.080
0.29
22/44
37.4/26.6
40
airblast/WP
0.70
0.25
1/92
190/100
Strawberries
1.00
350
aerial / liquid
0.15
0.29
25.3/44
107.1/126.6
80
groundboom / liquid
0.64
350
aerial / WP
0.080
0.29
22/44
37.4 /126.6
80
groundboom / WP
0.35
97.97
161.5/1
The application rates presented here are only a small sample of the range of rates available on product labels. In
general, if application rates, treatment method and acres treated are the same, the same MOEs will apply regardless
of the crop.
The highlighted values indicate MOEs that are not of concern.
(2) Post-Application Occupational Risk
The post-application occupational risk assessment considered exposures to workers entering
treated sites in agriculture. Workers may be exposed to diazinon on a short term or intermediate term
basis upon entering treated areas. All of the post application scenarios and post-application risk
calculations for handlers completed in this assessment are included in the Occupational and Residential
Exposure Assessment and Recommendations for the RED Document for Diazinon dated November
30,2000.
The following ten crop groupings are used to assess the post application exposures to diazinon;
(1) Low berry;
(2) Field row crop, low & medium
(3) Field-grown nursery ornamentals;
(4) Deciduous tree fruit;
(5) Nut trees;
(6) Root vegetables;
(7) Cucurbit vegetables;
(8) Fruiting vegetables;
(9) Brassica vegetables; and
(10) Leafy vegetables.
21
-------
The Agency has incorporated two post application exposure studies (i.e., dislodgeable foliar
residue) on cabbage and oranges and determined the transfer coefficients to calculate restricted entry
intervals (REIs). These transfer coefficients were derived fiom Agem^ data and transfe coefficient
studies submitted by the Agricultural Reentry Task Force (ARTF) and summarized by OPP's Health
Effects Division into an intermipoUcydoaiment(PoHcy 3 J) developed m August 20TO Data from
two crop-specific residue studies are used in HED's risk assessment as surrogates to represent other
crops not monitored but currently registered.
The results of the short term post application assessments indicated that REIs need to be
established. The REIs are presented in Table 7. The results of the dermal post application assessments
for workers exposed to diazinon for most agricultural activities indicate that MOEs are less than 100
(ie., unacceptable) at the current Worker Protection Standard (WPS) required restricted entry level
(REI) of 24 hours. For high end exposure activities (Le., hand harvesting mrnc^ instances) ttie short
term MOEs for post application workers did not reach 100 for 2- 4 days after treatment for most
vegetable crops, 4 days for fruit trees, 3 days for field crops, 3-5 days for berries, 2-7 days for
ornamentals and 7-18 days for tree nuts. The REIs were based exclusively on dermal exposures.
Hie potential for dermal contact during post application activities (e.g., harvesting) is assessed using a
matrix orpotential contact rates by activity and associated crops. This assessment is believed to be
reasonably representative of diazinon uses, except for nut trees and cut flowers, which lack adequate
transfer coefficient data.
Table 7. Summary of "The Days After Treatment" to Reach the Target MOE for Hand
Harvesting1.
CropGroopiae
Lowbeny
Field row crop.
ow & medium
Field grown
misery
ornamentals
Deciduous tree
hut
Tree nuts
toot vegetables
DbuiaoB Specific Croju '.
*'?: t._ '
» ^ ^ c '
Blackberries, raspberries, blueberries.
cranberries
itrawberries
leans, peas
carnation, chrysanthemum
cut flowers)
rail/burlap other types of ornamentals
inch as azalea, boxwood, dogwood,
uniper
apples, apricots, cherries, figs,
lectarines, peaches, pears, plums
lazelnuts
Umonds (dormant spray only)
>eets, carrots, onions, parsnips,
>otatoes, radishes
Max FQttar Rate
(Ibal/acre)
. * i ' '
2-3
1
0.75
2
1
2
3
3
0.5
I>«yi After Treatment
Short-term
*" * ITlTj^a ' JU/
5
3
3
7
2
4
18
7
3
Pffl
(day.)
5 to 7
5
7
NA
NA
21
45
NA
14+
22
-------
c^e|4^teg £
J::-"& ^ - *
Cacurbit
vegetables
Fruiting
vegetables
Brassica
vegetables
Leafy
vegetables
* ^» UiazinoB Specific Crops
°,-:!' ,>0iJ
cucumbers
melons
iwppers, tomatoes
;ole crops
ettace, parsley, spinach, Swiss chard
Mai Foliar Ratt
(Ibai/acre) .
«Tf > 51*1 "'
0.75
0.75
0.75
0.5
0.5
Days After Treatment <>
-' ^ ^pMHfXMl;
;;.pwi^itf£p(^^
3
3
2
4
3
r PHJ
*Cte3»>
7
3
Ito5
7
10+
(1) Results are for the high end exposure activity of hand harvesting.
(2) Short-term dermal NOAEL = 1 mg/kg/day (21-day rabbit dermal study with a 100 target MOE).
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 the Environmental Fate and Effects
Division (EFED) chapter, dated February 19,2002, available in the public docket In December
2000, EPA reached an agreement with the diazinon technical registrants to phase out all outdoor, non-
agricultural uses and certain agricultural uses. However, the EFED risk assessment was originally
conducted prior to mis agreement and includes some of the deleted uses.
1. Environmental Fate and Transport
Diazinon is moderately persistent and mobile in the environment Diazinon appears to degrade
by hydrolysis in water and by photolysis and microbial metabolism and to dissipate by volatilization
from impervious surfaces. Diazinon degrades by hydrolysis at all pH's tested Hydrolysis is rapid
under acidic condition, with a haJf-Hfe of 12 days at pH 5. Under neutral and alkahrie conditions,
diazinon hydrolyzed more slowly with abiotic hydrolysis half-lives of 138 days at pH 7 and 77 days at
pH 9. Diazinon is stable to photolysis in water, but was shown to degrade with a half-life of less than
two days on soil indicating that photodegradation may be important under certain circumstances.
Diazinon was shown to be moderately mobile in five soils with reported Freundhch adsorption
coefficients ranging from 3.7 to 23.4 mL/g. hi a soil column leaching study, aged (30 days) diazinon
residues were mobile with parent diazinon, and less mobile than oxypyrimidine, the major degradate of
diazinon.
In several supplemental terrestrial field dissipation studies submitted to the Agency, diazinon
dissipated with apparent field half-lives ranging from 5 to 20 days in the top 6 inch soil layer. These
dissipation half-lives are consistent with a compound which is registered for multiple applications fix
adequate pest control. These studies measure dissipation resulting m?m degradation, dilution and
movement from site. In two studies diazinon was detected to a depth of 48 inches; however, in most
studies, diazinon was recovered at a maximum of 18 inches.
Diazinon is not expected to bioaccumulate in fish based on rapid depuration of residues.
23
-------
2. Exposure Assessment
Terrestrial exposure
For pesticides applied as liquids, the estimated environmental concentrations (EECs) on food
items following product application are compared to LCSO values to assess risk with a Risk Quotient
(RQ) method. Estimates of maximum and average residue levels of diazinon on wildlife food was based
on the moo^l of Hoerger and Kenega (1972), as rnodified by Fletcher etal. (1994). EECs resulting
from multiple triplications are ''alnilPted frflTP *fae mgxgrnim niimher of applications, minimum
application interval, and foliar hah^Ufe data. For pesticides applied as granulars, EECs are calculated
as the number of lethal doses (LDsos) that are available within one square foot immediately after
application (LDjo/ft3). Applications which are incorporated are assumed to leave one percent of the
granules on the sofl surface (ie., 99% is incorporated). Risk quotients are calculated for three separate
weigjit classes of birds and mammals: 1000 g (e.g., waterfowl), 180 g (e.g., upland game bird), and 20
g (e.g., songbird).
Surface Water
For exposure to aquatic animals, EPA considers surface water only, since most organisms are
not found in ground water. Surface water models are used to estimate exposure to fteshwater aquatic
animals, since monitoring data are generally tint targeted studies on small water hndias and primary
streams, where many aquatic animals are found. The modelmg results are surnmarized here. Refer to
the EFED chapter for a detailed discussion of the water models.
The Agency used PRZM-EXAMS to calculate refined Estnnated Environm£ntal CorK^itrations
(EECs). The Pesticide Root Zone Model (PRZM, version 3.1) simulates pesticides in field runoff and
erosion, while the Exposure Analysis Modeling System (EXAMS, version 2.97-5) simulates pesticide
fete and transport man aquatic environment (one hectare body of water, two meters deep). EECs in
surface water resulting from the highest application rate on seven crop types (berries, tubers/bulbs, nuts,
stone fruits, pome fruits, vegetables, and other) were calculated. The crops were chosen based on the
uses for which the greatest amount of diazinon was applied according to usage data from 1992 - 1997.
These estimates for ecological risk differ from the drinking water EEC's, since the ecological
aquatic EECs were estimated with the fenn pond and not the Index Resewoir amendment to the
model. EEC's are tabulated below in Table 8.
24
-------
Table 8. Estimated Environmental Concentrations (EECs) Used in PRZM-EXAMS.
ilmond; aerial spray
7.94
639
rotatoes; broadcast
4.0
72.7
S8.9
45.7
ilueberries; aerial spray
1.0
37.7
32.8
22.4
peaches; aerial spray
2.0
91.2
80.5
67.2
apples; aerial spray
2.0
25.1
20.5
15.4
cucumbers; broadcast
4.0
429
356
258
These values reflect an aerial application of dazinonv^^niayresiilt in direct gsay drift
deposition into surface waters adjoining target use sites. For modeling purposes, fee drift potential for
aerial and ground spray is assumed to be equivalent to 5% of applied and 1% of applied, respectively.
3. Toxicity (Hazard) Assessment
a. Avian, Mammalian and Honeybee Toxicity
Diazinon is veryhigfaly toxic to birds and has been bnl^ to a number of bird kills. Thediazinon
acute oral toxicity LDso, administered as a single dose by oral intubation, ranges fiom 1 .44 (mallard
duck) to 69 (brown-headed cowbird). Nearly all studies found that diazinon is very highly toxic by me
acute oral route. Subacute dietary studies estimate the quantity of diazinon mixed in the diet mat causes
50% mortality. LCso values for technical diazinon ranged from 32 to 3,912 ppm. Almost all studies
found that diazinon is very highly toxic or highlytoxic. The toxicrty values used to calculate the acute
avian risk quotients (RQ) can be found in Table 9.
Table 9. Technical Diazinon Acute Oral Toxicity to Birds
v.^/'Sl-Jfrv
MR1D 40895301
\cute Oral (Single dose by gavage)
tfRID 40895302
Subacute dietary1 (five days of treated
Teed)
Bfc*ifc#
-------
Table 10. Technical Diazznon - Reproductive Toxicity to Birds
SCUD 41322901
Mallard Duck
8.3
1633
Significant reduction in the number of 14-day
hatcfaling survivors.
Wild mammal testing is required on a case-by-case basis, depending on the results of lower tier
laboratory mammal studies, intended use pattern, and pertinent environmental late characteristics. In
most cases, rat or mouse toxicity values obtained from me Agency's Health Effects Division (HED)
substitute for wild mammal testing. Diazinon is characterized as moderately to practically nontoxic to
small mammals on an acute oral basis (LDjo tor combined sexes was 1250 mg/kg). In a mufti
generation reproduction study (MRID 41 158101), far parental/systemic toxicity, the NOAEL is 0.67
mg/kg/day and the LOAEL is 6.69 mg/kg/day based on decreased parental weight gam. For offspring
toxicity, the NOAEL is 0.67 mg/kg/day and LOAEL is 6.69 mg/kg/day based on pup mortality and
decreased weight gain.
Diazinon is highly toxic to bees and other beneficM inserts on an acute contact basis.
for technical diazinon is 022 ug ai/bee (MRID 05004151).
b. Toxicity to Aquatic Animals
Technical diazinon has been shown to be moderately toxic to very highly toxic to freshwater fish
ranging from 90 to 7,800. A freshwater fish lifecycle test is designed to estimate the
quantity of toxicant required to adversely afreet the reproductrve capabilities of a test po
The toxicity values appearing in Table 11 will be used to calculate the acute and chronic aquatic risk
quotients.
Table 11. Acute and Chronic Toxicity of Diazinon to Fish
SOUD 40094602
&cute Toxicity
EUinbow
Trout
90.0
very highly toxic
MRTDROODI007
Chronic Toxicity
Brook Trout
<0.55
<0.55
inhibited growth first 3 months, neurological
symptoms, reduced growth in progeny
A freshwater aquatic invertebrate toxicity test is used to establish the acute toxicity of diazinon to
aquatic invertebrates. Diazinon is very highly toxic to freshwater aquatic irrvertebrates on an acute basis
with an £50 of 02. A freshwater aquatic invertebrate Hie cycle test is used to determine chronic
effects. The toxicity values appearing in Table 12 are used to calculate the acute and chronic risk
quotients for aquatic invertebrates.
26
-------
Table 12, Acute and Chronic Toxitity of Diazmon to Aquatic Invertebrates
VtRID 40094602
Acute Toxicity
Scud
0,20
rery highly toxic
VfRID 40782302
Chronic Toxicity
Daphnid
(Daptmia magna)
0.17
0.32
mortality of all test organisms at two
highest concentrations (0.32 and 0.83 ppb)
Acute toxicity testing with estuarine and marine fish and invertebrates is required for diazinon
because end-use products are expected to reach the marine and estuarine environment because of its
use in coastal counties. The LCjosfium several studies range from 150 to 1,500 ppb categorizing
diazinon as highly to moderately toxic to estuarine and marine fish on an acute basis. An estuarine and
marine fish early life-stage toxicity studly measures chronic toxicity. The toxicity values appearing in
Table 16 arc used to calculate the acute and chronic risk quotients for estiiarine and marine
invertebrates.
For estuarine and rnarine invertebrates the LCy/EC^ tall in the range of 42 to >1000.0 ppb,
diazinon is categorized as very highly to moderately toxic on an acute basis. An estuarine and marine
life cycle study measures chronic toxicity. The toxicity values appearing in Table 13 are used to
calculate the acute and chronic risk quotients for estuarine and marine invertebrates.
Table 13. Acute and Chronic Toxicity of Diazinon to Estuarine and Marine Invertebrates
MRID 40625501
Acute Toxicity
Mysid shrimp
= 4.2;NOAEC =
tiighly toxic
MRID 44244801
Chronic Toxicity
Mysid shrimp
0.23
0.42
growth (weight)
c.' Toxicity to Plants
A greater than 25% detrimental effect level on radical length was observed in oat, carrot and
tomato seedling emergence and a 25% or greater detrimental effect on vegetative vigor, as measured in
plant height, was observed on onion, cucumber and tomato. Aquatic plants are also affected by
diazinon.
Aquatic plant testing is required for diazinon because of its terrestrial outdoor use pattern, its
ability to move oflsite in both surface and ground water, and its demonstrated phytotoxicity, as
determined in the terrestrial plant testing. The toxicity values appearing in Table 14 are used to
calculate acute risk quotients.
27
-------
Table 14. Nontarget Terrestrial Plant Toxicity
Plant seedling emergence
Endpoint affected
ECjj/ECw (Ibs ai/A)
Monocot - Oat
Shoot height
5.26/0.17
Vegetative vigor
Endpoint affected
ECVECoj (Ibs ai/A)
Dicot - cucumber
Shoot height
3.23 /127
Aquatic plant
Endpoint affected
jrecn Algae (Selenastrum capricomaum)
Growth
3.7/<0.06
4. Ecological Risk Calculations
Levels of Concern
Risk characterization integrates the results of the exposure and ecotoxicity data to evaluate the
likelihood of adverse ecological effects by using risk quotients (RQs). RQs are calculated by dividing
exposure estimates by acute and chronic ecotoxicity values:
RQ = EXPOSURE/TOXTOTY
RQs are then compared with QPP's levels of concern (LOCs). These LOCs are used by OPP to
analyze potential risk to nontarget organisms and the need to consider regulatory action. Thecriteria
indicate that a pesticide used as directed has the potential to cause adverse effects on nontarget
organisms. Risk presumptions, along with the corresponding LOCs are summarized in Table 15. The .
ecotoxicity test values (measurement endpoints) used in the acute and chronic risk quotients are derived
from required studies.
Table 15. Risk Presumptions for Terrestrial and Aquatic Animals
\cnte Risk there is potential for acute risk; regulatory action may be
warranted in addition to restricted use classification,
0.5
Acnte Restricted Use -there is potential for acute risk, but may be mitigated
through restricted use classification,
0.2
0.1
Acnte Endangered Species -endangered species may be adversely affected;
regulatory action may be warranted,
0.1
0.05
Chronic Risk -there is potential for chronic risk; regulatory action may be
warranted.
28
-------
b. Risk to Birds and Mammals
Diazinon has acute and chronic risk to birds. Diazinon acute RQs for birds exceeded the acute
risk LOG (0.5), restricted use LOG (0.2), and endangered species LOG (0.1) for all uses evaluated
Also, practically all chronic RQs exceeded the chronic LOG (1.0). This was true for single and multiple
applications, nongranular and granular applications, banded/in-furrow, as well as broadcast application
methods, and for seed treatments. The table below provides ranges of RQs for the various formulation
and application types. RQs tor non-granular products are calculated based on residues on particular
types of foodstuffs. RQs for granular products are calculated based on the number of lethal doses
(LDSOs) that are available within one square foot immediately after application (LD50s/sq. ft). Birds
may be exposed to granular pesticides by ingesting granules when foraging for food and grit or drinking
contaminated water.
Table 16. Ranges of Avian Acute and Chronic Risk Quotients for Various Formulation and
Application Types.
** fyi
Non-granular formulation, single application
Non granular formulation, multiple applications
Granular, broadcast,
Granular, banded, incorporated
Seed treatment
0.23 - 30
0.37-46.82
1.08-1446.25
95- 4725
0.03-1.58
SW^fe-fX
0.90-115.66
1.41-180.50
Not calculated
Not calculated
Not calculated
Granular and seed treatment RQ's are based on differing weights of various types of birds
Risk quotients for mammals are calculated for three separate weight classes of mammals (15,35,
and lOOOg), each presumed to consume four different lands of fixxls (grass, forage, insects, and
seeds). Trie concentration of diazinon in the diet that is expected to be acutely lethal to 5^^^
population (LC50) is determined by dividing the LDjp value (usually the acute oral rat LDi0) by fee
percent body weight consumed The RQ is theii deterrrmed by dividing the EEC by the derived LC^
value. By dietary and oral routes, diazinon is classified as moderately acutely toxic to small mammals.
For single and multiple applications of non-granular diazinon products, the mammalian high acute
level of concern is exceeded for many of the uses evaluated. RQs range up to 1.8 for a 35 g mammal.
For applications of diazinon granular products (broadcast and banded) the mammalian high acute level
of concern is exceeded for many of fee uses evaluated wife RQs ranging up to 5.5 for small mammals
from the use on apples.
Diazinon is chronically toxic to mammals, and the chronic RQs for mammals exceeded the LOG
(1.0) for all uses of diazinon at maximum application rates wife chronic RQs ranging from 12 from use
on bananas up to 85.7 for use on cranberries.
29
-------
c. Risk to Aquatic Species
Because of diazinon's widespread use in the U.S., and documented widespread presence in
water bodies at concentrations of concern to aquatic life, there is a high level of certainty that aquatic
organisms will be exposed to potenb^lly toxic levels of diazirKmm Since diazinon and its
major degradate oxypyrimidme are mobile and persistent in the euvkouuient and found at significant
levels in surface water, it is quite probable that they wifl be available in quantity and fe times fliat will
exceed acute and chronic toxicity endpoints.
Aquatic invertebrates appear to be highly sensitive to diazinon on an acute and chronic basis.
Acute freshwater invertebrate risk quotients range from 53.5 for grapes to 2,145 for cucumbers.
Chronic RQs range from 53.5 to 2094 for the same crops. These risk quotients indicate great risk
potential to aquatic invertebrates at all use sites. Populations of aquatic invertebrates may recover over
time, but their lowered numbers can potentially have an effect on the health of animals that prey on
them, depending on alternative food sources and the oveiaU health of me ecc«ystem prior to the
introduction of me toxicant
Although diazinon does not appear to be as acutely toxic to fish as it is to freshwater aquatic
invertebrates, the estimated envircHmieaital concen
of acute toxicity to fish for some application rates. Acutemortality to fish is thus a possibility, even
though mere are no reported fish kills incidents m EOS that have been dearly liriked to diazmon.
Chronic RQs from freshwater fish range from 11.6 for almonds to 469 for cucumbers, indicating mat
chronic effects to fish are clearly possible.
d. Risks to Nontarget Plants
Terrestrial plants inhabiting dry and semi-aquatic areas may be exposed to pesticides from
runoff, spray drift, or volatilization. Exposine to ramtarget aquatic plants inay occur through nmofT or
spray drift from adjacent treated sites or directly from such uses as aquatic weed or mosquito larvae
control. Diazrnon does not have any aquatic uses. EECs are calculated for the following application
methods: unincorporated ground applications; incorporated ground application; and aerial, airblast,
forced-air, and chemigation applications. For single and multiple applications, acute high risk levels of
concern are not exceeded for terrestrial and semi-aquatic plants for the registered application rates of
diazinon. For single applications, endangered species levels of concern are exceeded for terrestrial and
semi-aquatic plants tor vegetable crops. For single or multiple applications, the non-vascular acute high
aquatic plant risk levels of concern are not exceeded for the registered application rates of diazinon.
5. Ecological Incidents
Based on EPA's Ecological Incident Information System (HIS), daizinon has caused the second
largest number of total known incidents of bird mortality of any pesticide. Diazinon has tbe highest
number of bird mortality incidents (58) caused by any pesticide from 1994 to 1998 and it has the
highest total niimber per million acres treated. There has been a trend inEIIS of steadily increasing
30
-------
numbers of diazinon related incidents over the years. Diazinon has high use on lawns and other turf,
and the majority of incidents on known sites have occurred here, with the remaining incidents on a
variety of residential, agricultural, or unknown sites. Inddents have occurred with both liquid and
granular formulations of diazinon. The largest kills are generallywith waterfowl Waterfowl frequently
travel in larger flocks and are attracted to turf areas, particularly if water is nearby.
In conclusion, diazinon has caused widespread and repeated mortality of birds. The mortality
has been well documented over many years and there is hi^ c^tainty regarding diazinon*s risk to
birds. In 1988, diazinon was cancelledfor use on golf courses and sod farms due to its high risk to
birds. The risk to birds is very high on other sites as well, since birds can be attracted to a wide range
of turf and agricultural sites. Thecontinued mortalities over theyears indicate that neither lower
application rates on turf sites, nor the various added label environmental hazard statements, have been
adequate to prevent bird mortalities. Mortality is likely to continue in the future if diazinon continues to
be used on sites where birds can be exposed.
6. Endangered Species
Endangered species LOCs are exceeded for multiple taxonomic groups of organisms on most
application sites. The USFWS has determined thai diazinon is likely to jeopardize multiple aquatic and
terrestrial species. The 9/14/89 Biological Opinion, for example, lists a total of 88 federally-listed
endangered/threatened aquatic and terrestrial species that the USFWS considers to be in jeopardy due
to diazinon use. Corn, sorghum, cotton, and soybeans covered by this Biological Opinion are among
the use sites listed in the January 22,1999 Use Closure memo that were included in this environmental
risk assessment
In 1989 the USFWS issued a biological opinion on diazinon in response to EPA'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 thepreceding factors or unio^ to the situation being evaluated Given the
evaluation criteria, a total of 132 species (5 bird, 6 amphibian, 77 fish, 32 mussel, 6 crustacean, 4
miscellaneous aquatic invertebrates, and 2 snake) were considered potentially affected by the use of
diazinon. Of these organisms potentially affected, the USFWS listed 84 aquatic species as jeopardized,
of which fee majority (56%) were endangered/threatened species of freshwater fish. Four terrestrial
(avian) species were also classified as being in jeopardy. The remaining potentially affected organisms
were listed either as having no potential far exposure or as not being in jeopardy.
For all of the species listed as jeopardized the USFWS lists reasonable and prudent alternatives
(RPA) to mitigate the effects of diazinon use. For some of the species listed as not jeopardized, the
USFWS lists reasonable and prudent measures (RPM) and incidental take (IT) to mitigate effects For
details on the RPA and RPM recommendations, the reader is referred to a USFWS 1989 publication.
31
-------
Many additional species, especially aquatic species, have been federally listed as
endangereoVthreatened since the biological opinion of 1989 was written, and determination of jeopardy
to these species has not been assessed for diazinon. Additionally, recent literature does document
direct biological effects on a species, ie., chinook salnxjo, wife populations subseqiientiyHsted as
threatened and/or endangered (USFWS Species Profile 10/13/2000) or proposed for listing, e.g.
Atlantic salmon (USFWS Service Species Profile 10/13/2000). As noted earlier, sublethal effects
could reduce reproductive success, diniinish the genefc "purity" of specrfo
vulnerability to predation and thereby aoVereety intact ttneatenedYendangered species.
When the regulatory changes recommended in the IRED are implemented and (he ecological
effects and environmental fete data are submitted and accepted by the Agency, the Reasonable and
Prudent Alternatives and Reasonable and Prudent Measures in the Biological Opinions) may need to
be reassessed and modified based on the new information.
The Agency is currently engaged in a Proactive Conservation Review with FWS and the
National Marine Fisheries Service under section 7(aXl) of the Endangered Species Act The objective
of this review is to clarify and develop consistent processes fe endangered spedes risk assessments
and consultations. Subsequent to the completion of this pzoce^tte
effects of diazinon use to federally fisted threatened and endangered species. At that time the Agency
wifl also consider any regulatory changes reoommenoW in ti» IRED that are beir^ irnpfcnient^ Until
such time as tins analysis is completed, the overall environmental effects mitigation strategy articulated in
this document and any County Specific Pamphlets described in Section IV, which address diazinon, will
serve as interim protection measures to reduce me hTcehliood that eridangeired and thre
may be exposed to diazinon at levels of concern.
7. Risk Characterization
DSazmoob an oigaiwphosphate feat works by M The toxic effect
is the disruption of normal neuromuscular control. Death can occur rapidly, ote primarily to
asphyxiation as muscles associated with respiration undergo tetany. Organophosphate exposure can
also result in chronic effects in animals such as reproouctrve impairment and o^a
a. Terrestrial Organisms
There are several reasons why risk assessments may underestimate risk for those organisms
exposed to pesticides. Compared to animals in fee laboratory, animals in the wild might be more
susceptible because they are exposed to multiple stressors in addition to the chemical (e.g., extreme
envirorjmental conditions, predation pressure, and disease). Furthermore, terrestrial vertebrates
tnrhidmg hmfe^ Tnarnmfll^ neprilaSj and amphibians may he evpnsed tn ftiaTtnnn not nnly thmiigh nrql
and dermal exposure, but also through inhalation exposure. The Agency's assessment only considered
risks from oral exposure.
32
-------
An extensive amount of data demonstrate diazinon's high acute toxicity to birds. Practically all
avian acute and chronic RQs exceed the LOCs for all calculated uses. Among pesticides, diazinon is
the cause of the second most documented avian mortality incidents. Hie majority of incidents on known
sites have occurred on lawns and other turf, but incidents have also been reported on a variety of other
residential and agricultural sites. Many documented bird kills have occurred on (residential) turf sites.
As part of the mitigation required in the December 2000 Memorandum of Agreement signed by the
diazinon technical registrants, outdoor, non-agricultural uses (including home and garden, lawn, and turf
sites) will be phased out and cancelled by December 31,2004. The Agency believes that these new
use restrictions wiU significantly reduce risk to birds. However, bird kills have also been reported on
agricultural sites.
By dietary and oral routes, diazinon is classified as moderately acutely toxic to small mammals
and is, therefore, considerably less toxic to mammals thantobirds. In addition, diazinon has
demonstrated chronic toxicity to mammals at low levels. There are no wild mammal incident reports in
the Ecological incident Information System (EUS) mat clearly document diazinon as the cause of death,
either directly or through scavenging the carcass of a bird or other organism killed by diazinon.
b. Aquatic Organisms
Because of diazmon's widespread use and documented presence in water bodies at
concentrations of concern to aquatic life, mere is a high level of certainty mat aquatic organisms can be
exposed to potentially toxic levels of diazinon in surface water. Since diazinon and its major degradate
oxypyrimidine are mobile and persistent in the en\dromnent, and tound at significant kvels in smfece
waters; it is quite probable mat they will be available in quantity and for times that will exceed acute and
chronic toxicity endpoints. Aquatic invertebrates are highly sensitive to diazinon on an acute and
chronic basis. Measured levels of diazinon from monitoring studies exceed lethal levels, and
populations of invertebrates may be severely reduced or eliminated in these areas. Populations of
aquatic invertebrates may recover over time but their lowered numbers can potentially have an effect on
the health of animals mat prey on them and the overall health of the aquatic ecosystem prior to the
introduction of the toxicant
Although diazinon does not appear to be as acutely toxic to fish as it is to freshwater aquatic
invertebrates, the EECs from the water modeling are within the range of acute toxicity to fish for some
application rates. Acute mortality to fish is thus a possibility, even though mere are no reported fish kill
incidents which have been clearly linked to diazinon. Following acute exposure to diazinon, fish have
exhibited lethargy when undisturbed, abnormal forward extension of the pectoral fins, darkened areas
on the posterior part of the body, and when startled, sudden rapid swimming in circles followed by
severe muscular contractions. Chronic RQs indicate that chronic effects to fish are dearly possible.
There are reports of reduced reproduction rates, malformed fiy, and lowered cholinesterase levels in
fish exposed to low levels of organophosphates in water.
33
-------
Studies on subletfaal efiects indicate mat diazinon inhibits oh^ctory fimction in salmon. Salmon
exposed to environmentally relevant concentrations were significantly less cognizant of a threat of
predation and had diminished ability in detecting natal waters. Subtemal effects including lethargy and
unusual movements in the water stemming from scoliosis, lordosis and poor fin coordination are likely to
increase vulnerability to predation.
There is high certainty that in all urban and suburban areas where diazinon is applied outdoors
and where irrigation or rainfall cause runoff; there will be negative impacts m aquatic biota fixm me
diazinon use. The Agency believes mat the phase out and eventual cairallation of outdoor, non-
agnrnfriiral iKa*e hy Darf-nitier 31 2004. will gigm'firantiy nediine the amount of itia-yjnnm mntommxtiem
in aquatic environments. However, ninoiffirmi treatment of agric^tiiral sites has also been 1^^
aquatic contamination.
In conclusion, diazinon use has been shown to afiect terrestrial and aqiiatic wfldlife. The risk
assessment shows high risk to avian species and mis conclusion is supported by bhtf kiU incidents.
AHfrnaigh most hhd incidents are linked to residential and fan-fuses, agrirailtiiral IKPS have plsn ranged
adverse effects to birds.
To date, diazinon has been detected in the rivers, creeks, and/or streams of 30 states and the
District of Columbia. Fnvimnmental fate data predirt ftiat water mntamtnatinn will nmir finm diar-mrm
use. Because of diazinon's widespread use and documented widespread pi^sence in water bodies at
concentrations of concern to aquatic life, there is a high level of certainty mat aquatic organisms will be
exposed to potentially toxic levels of diazinon in surface water.
IV. Interim Risk Management and Reregjstration Decision
A. Determination of Interim Reregistration Eligibility
Section 4(gX2XA) of FIFRA calls for the Agency to determine, after submissions of relevant
data concerning an active ingredient, whether products .containing the active ingredient are eligible for
reregjstration. The Agency has previously identified and required submission of generic (i.e., an active
ingredient specific) data required to support reregjstration of products containing diazinon.
The Agency has completed its assessment of the occupational and ecological risks associated
with the use of pesticides containing the active ingredient diazinon, as well as a diazmon-specific dietary
risk assessment that has not considered the cumulative effects of organophosphaies as a class. Based
on a re view of these data and public comments on the Agency's assessments for the active ingredient
diazinon, EPA has sufficient information on me human health and ecological effects of diazinon to make
interim decisions as part of the tolerance reassessment process under FFDCA and ^registration under
FIFRA, as amended by FQPA. The Agency has determined mat agricultural use of diazinon, based on
currently approved labeling, pose occupational and ecological risks. However, the Agency believes
mat these risks can likely be acceptably mitigated through changes to pesticide labeling and
34
-------
formulations. Accordingly, the Ager^ has detemiined that products contain^
reregistzation provided mat: (i) additional data that the Agency intends to require confirm this interim
decision (ii) the risk mitigation measures outlined in this document are adopted and label amendments
are made to reflect these measures; and (iii) cumulative risks considered for the organophosphates
support a final reregistration eligibility decision. Label changes are described in Section IV. Appendix
B identifies the generic data requirements mat the Agency reviewed as part of its interim determination
of reregistration eligibility of diazinon and lists the submitted studies that the Agency found acceptable.
The additional data mat the Agency intends to require are described in Section V.
Although the Agency has not yet considered amralanwrisks^meoigarKqdK)srAiates,me
Agency is issuing mis interim assessment raw in order to identify risk reduction measures m^
necessary to support fee continued use of diazinon. Based on its current evaluation of diazinon alone,
the Agency has determined that diazinon products, when used in accordance with the current labeling,
would present risks inconsistent with FIFRA. Ao«idingly, should a registrant M to implement any of
the risk mitigation measures identified in this docimtt^ me Agency may take icgulatory action to
address the risk concerns from use of diazinon.
Ihe Agency will address any outstanding risk concerns when me cumulative assessment is
conducted For diazinon, if aU changes outlined in this docinneiit are iiKx^r^^
current risks identifiedin mis documentwill be acceptably mitigated. But because this is an interim
RED, the Agency may take former actions, if warranted, to finalize the reregistration eligibility decision
for diazinon after assessing the cumulative risk of me organophosphate class. Such an incremental
approach to the reregistration process is consistent with the Agency's goal of improving the
transparency of the reregistration and tolerance reassessment processes. By evaluating each
organophosphate individually and identifying appropriate risk reduction measures, the Agency is
addressing the risks from the organophosphates in as timely a manner as possible.
Because the Agency has not yet considered cumulative risks for me organophosphates, this
reregistration eligibility decision does not fully satisfy the reassessment of the existing diazinon food
residue tolerances as called for by the Food Quality Protection Act (FQPA). When the Agency has
considered cumulative risks, diazinon tolerances will be reassessed in that light At that time, the
Agency will reassess diazinon, along with the other organophosphate pesticides, to complete the FQPA
reqimements and make a final reregistration eUgMity deteirnination. By publishing this interim decision
on reregistration eligibility and requesting mitigation measures now for me Mviou^
the Agency is not deferring or postponing FQPA requirements; rather, EPA is taking steps to assure
that uses which exceed FIFRA's unreasonable risk standard do not remain on the label indefinitely,
pending completion of assessment required under the FQPA, This decision does not preclude the
Agency from making further FQPA determinations and tolerance-rebted nilemakings that may be
required on mis pesticide or any other in the future.
If the Agency determines, before finalization of the RED, that any of the determinations described
in this interim RED are no longer appropriate, the Agency will pursue appropriate action, including, but
not limited to, reconsideration of any portion of mis interim RED.
35
-------
1. Summary of Phase 5 Comments and Responses
When maldng its interim raegistratim decision, tte Agei^
received during Phase 5 of the OP Pilot Process. These comments in their entirety are available in me
docket
Among others, comments were received from the following: pesticide manufacturers (e.g^
Makhteshim-Agan of Norm America Inc., Syngenta Crop Protection Inc., etc.) various local municipal
governments (e.g., Seattle City Council, City of RosweU, Georgia, etc.), other government agencies
(e.g., TJSDA, Texas Department of Agriculture, etc.), agricultural groups (e.g., National Potato
Council, Almond Hollers & Processors Associated, etc.), environmental advocacy groups (e.g.,
American Bird Conservancy, Washington Toxics Coalition, etc.), regional water quality groups (e.g.,
California Regional Water Quality Board, California Stonnwater Quality Task Force, etc.), and private
citizens.
Many of the municipal governments, envnonmental advocacy groiips, ami pn
rornmentedmravoroffijrth^ Agn^aihural groups tended to stress the
benefits of diazinon for their crops. Many parties provided EPA with data or information on the use of
diazinon.
B. Regulatory Position
1. FQPA Assessment
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
this organophosphate. The assessment is for this imtividual ragaiK^hosphate, and does not attempt to
fully reassess these tolerances as required under FQPA. FQPA requires the Agency to evaluate food
tolerances on the basis of cumulative risk from substances sharing a common mechanism of toxicity,
such as the toxicity expressed by the organophosphates through a common biochemical intezaction with
the cholinesterase enzyme. The Agency wfll evaluate the cumulative risk posed by the entire class of
organophosphates once the methodology is developed and the policy concerning cumulative
assessments is resolved.
EPA has determined mat risk fiom exposure to diazimm is within its own''risk cup." In other
words, if diazinon did not share a common mechanism of toxicity with other chemicals, EPA would be
able to conclude today that the tolerances for diazinon meet the FQPA safety standards. In reaching
mis determination, EPA has considered the available information on the special sensitivity of infants and
children, as well as the chronic and acute food exposure. An aggregate assessment was conducted for
exposures through food and drinking water. Results of this aggregate assessment indicate that the
36
-------
human health risks from these combined exposures are considered to be within acceptable levels; that
is, combined risks from all exposures to dia2irtontW'wifliin the individual risk cup. Therefore, the
diazinon tolerances remain in effect and unchanged until a lull reassessment of the cumulative risk from
all organophosphates is considered
b. Tolerance Summary
hi the individual assessment, tolerances for residues of diazinon in/on plant commodities [40 CFR
§180.153] are presently caressed in terms of the parent compound only (0,0-diethyl
-memylemyl)-4-pyr^
Table 17. Tolerance Summary for Diazinon.
*£V*«jr v* . «fcWTi«M&& ;- t&fes«&i ^^LiLiLi °= :'v -i^-f^*-*'*
P""»**-'--' , ; ' :^^^^^^^^^^m::!^^' , ,'% -:^\-
Tolerances Listed Under 40 CFR § 186.153
\lfalfa, fresh
Alfalfa, hay
Almonds
&lmoads, hulls
Apples
Apricots
Bananas
Beans, gnar
Beans, Kaa
Beans, snap
Beets, roots
Beets, sugar, roots
Beets, sagar, tops
Beets, tops
Blackberries
blaeberries
Boysenberries
Carrots
Cattle, fat
Cattle, meat
Cattle, mbyp
40.0
10.0
0.5
3.0
0.5
0.5
0.2
0.1
0.5
0.5
0.75
0.5
10.0
0.7
0.5
0.5
0.5
0.75
0.7
0.7
0.7
NA
NA
0.5
3.0
0.5
0.5
0.2
0.1
0.5
0.5
0.75
0.5
10.0
0.7
0.5
0.5
0.5
0.75
0.5
0.7
0.7
propose revocation; no registered
uses
propose revocation; no registered
uses
NMT 0.1 ppm shall be present in the
pulp after peel is removed
propose revocation; no registered
uses
pre-slaughter application
'at basis, pre-slaughter application;
imposed for revocation on
7/11/2002
at basis, pre-slaughter application;
proposed for revocation on
7/11/2002
37
-------
Ki^^i^u. * CuweStToleraBee*
Commodity - *
-* > ,v ,*, , ,, + , , .ppm
Celery
Cherries
Chicory, red (tops)
Citrus
Clever (fresh)
Clover, hay
Coffee beaas
Cora, forage
Cora (imet K=CWHR)
Cottonseed
Cowpeas
Cowpeas, forage
Cranberries
Cucumbers
Dandelions
Dewberries
Endive (escarole)
rig«
nions
0.7
0.75
0.7
0.7
40.0
10.0
0.2
40.0
0.7
0.2
0.1
0.1
0.5
0.75
0.7
0.5
0.7
0.5
0.5
0.75
0.75
0.75
0.75
1.0
0.7
0.75
0.75
0.75
0.5
1.0
0.75
: Tolerance -,,<.; ,. . . , - ' . . ;
=-. - "-- .* : CcoanBraffi, , - - ', > -:
- Reassessment*, ppm .,. -- ,-.,-..- ^ ^ . --
0.7
0.75
0.7
0.7
NA
NA
NA
40.0
0.7
NA
NA
NA
0.5
0.75
NA
0.5
0.7
0.5
0.5
0.75
0.75
0.75
NA
NA
0.7
0.75
0.75
0.75
0.5
'NA
0.75
also known as radicchio
propose revocation; no registered
uses
propose revocation; no registered
uses
propose revocation; no registered
uses
propose revocation; no registered
uses
propose revocation; no registered
uses
iropose revocation; no registered
uses
propose revocation; no registered
uses
iropose revocation; no registered
uses
iropose revocation; no registered
uses
iropose revocation; no registered
uses
38
-------
5**$fof >-.|;.£?*Si5r£
Parsley
Parsnips
Peaches
Pears
Peavine, hay
Pea vines
Peas with pods
Peppers
Pineapples
Plains
Potatoes
Potatoes, sweet
Radishes
Raspberries
Rutabagas
Sheep, fat
Sheep, meat
Sheep, mbyp
Sorghum, forage
Sorghum, grain
Spinach
Squash, summer
Squash, winter
Strawberries
Swiss chard
Tomatoes
Turnips, roots
Turnips, tops
Vegetables, leafy
Walnuts
Watercress
0.75
0.5
0.7
0.5
10.0
25.0
0.5
0.5
0.5
0.5
0.1
0.1
0.5
0.5
0.75
0.7
0.7
0.7
10.0
0.75
0.7
0.5
0,75
0.5
0.7
0.75
0.5
0.75
0.7
0.5
0.7
Cto£S^»! '-^*.:, - *';%".
0.75
0.5
0.7
0.5
10.0
25.0
0.5
0.5
0.5 .
0.5
0.1
0.1
0.5
0.5
0.75
0.7
0.7
0.7
NA
NA
0.7
0.5
0.75
0.5
0.7
0.75
0.5
0.75
0.7
0.5
0.7
determined on peas after removing
any shell present when marketed
fresh prunes
pre-slaughter application
fat basis; pre-slaughter application
fat basis; pre-slaughter application
propose revocation; no registered
uses
propose revocation; no registered
uses
Brassica (cole)
* The term "reassessed" here is not meant to imply that the tolerance has been reassessed as required by FQPA,
since this tolerance may be reassessed only upon completion of the cumulative risk assessment of all
organophosphates, as required by this law. Rather, it provides a tolerance level for this single chemical, if no
cumulative assessment was required, that is supported by all of the submitted residue data.
39
-------
The following commodities, for which all uses have been previously canceled and tolerance
revocations have been recommended, are not inchided in &K dietary assessment ohves, beans (guar),
and cowpeas. The potential for transfer of residues to meat, milk, poultry and eggs from animal feeds
have been reassessed It has been determined mat measurable secondary residues in these tissues are
not likely as a result of din/mem, residues in animal feed items. Dennal treatments are not being
supported for any livestock or poultry except cattle (ear tags). Therefore, the following commodities
are not included in this dietary assessment milk, all pod^ meats and meat byproducts, eggs, and
livestock meats and meat byproducts - except for the meat, meat byproducts and tat of sheep and the
fat of beef. Though thereis no registered use for demial treatment of sheep, the tolerance is ncrt being
revoked because residues may be found in imported sheep commodities. There are also regulations
permitting
-------
a. Mitigation for Agricultural Uses
The Agency has identified the following mitigation measures that reduce risks to agricultural
workers and wildlife to levels the Agency considers reasonable:
Cancellation of all granular registrations.
Hie only exception are two current Section 24(c) registrations held by Washington and
Oregon for control of the cranberry girdler. Three other Section 24(c) registrations held
by Massachusetts, New Jersey, and Wisconsin will be phased out in 5 years in order to
give cranberry growers in these states adequate time to implement cultural practices to
control cranberry girdler.
Granular use on lettuce will only be allowed in California with a five year phase out in
order to give lettuce growers adequate time to adapt to liquid application or to find
alternatives to diazinon.
* Deletion of aerial application for all uses.
Deletion of foliar application on all vegetable crops,
Hie only exception will be for treatment of leafhopper on honeydew melons in California.
Foliar treatment on leaf lettuce will only be aUowed m California with a five year phase out
to give growers adequate time to investigate alternatives to diazinon.
Application rate reduction.
The maximum rate for ornamentals (except cut flowers) will be reduced from 2 Ib ai/acre
to 1 Ib ai/acre. The maximum granular rate forlettuce (during the five year phase out)will
be reduced from 4 Ib ai /acre to 1 Ib ai/acre.
Establishment of crop specific REIs.
REIs of 2 days to 18 days will be established for all crops..
* Cancellation of all seed treatment uses.
Five uses will be cancelled: beans (snap), beans (lima), corn (field), com (sweet), and
green peas.
Require engineering controls for all uses.
All application equipment must use lock and load engineering controls. All wettable
powder formulations must be packaged in water soluble bags. Closed cabs are required
for all ground equipment
Reduction in the number of applications of diazinon per growing season.
On most uses only one application per growing season will be allowed Cropswith
dormant season and in season uses (e.g., stone fruits) will have one application per season
- for a total of two applications per year. Other exceptions are noted in the Labeling
Summary Table in Chapter 5.
41
-------
Application limitations and labeling on orchard crops.
For all orchard crops (nuts, stone fruits, pome fruits, etc) with dormant season uses, label
language will be added to labeling suggesting thai applications should be made every other
year unless pest pressures are such that consecutive, annual treatments are necessary.
* Cancelled uses.
Section 3 uses: Chinese broccoli, Chinese cabbage, Chinese mustard, Chinese radish,
com, grapes, hops, mushrooms, sugar beets, walnuts, and watercress. Watercress use
will be phased out over 4 years.
Section 24(c) uses: control of cranberry girdler for grass grown for seed (Oregon);
dipping of pineapple seed pieces (Hawaii); drenching around residential fruit trees for
control of Mediterranean fruit fly (California).
In light of the necessary adjustments that need to be made, such as replacing equipment and
investigating diazinon alternatives, the Agency believes that it is reasonable to allow two years, except
as noted above, to put these mitigation measures in place.
D. Benefits Assessment Summary
Benefits information was lequiredfbr diazinon based on risks to workers and wildhfe. Benefits
assessments evaluating the economical and agricultural effects of cancellation of diazinon were prepared
for the following crops because over five percent of the crop is treated with diazinon: almonds, apricots,
blueberries, broccoli, Brussels sprouts, cabbage, caneberry crop group, carrots, cauliflower, cherries
(sweet), cranberries, hops, lettuce, melons, nectarines, onions, peaches, pears, plums, prunes, radishes,
strawberries, and tomatoes. These assessments can be found in the diazinon docket and will be posted
on OPP's website.
Diazinon is used mainly to control foliar pests (aphids, leamoppers, mites, scale, etc.) on orchard
crops, fruits and vegetables, and soil pests (cutworms, wireworms, root maggots, mole crickets, etc.)
on vegetables. Foliar pests on vegetable crops can be controlled with effective, registered alternatives.
Certain foliar pests on fruits (e.g., Raspberry Crown Borer on caneberries) and orchard crops (e.g.,
scale on almonds) cannot be effectively controlled with alternative insecticides. One of diazinon's most
in^x>rtant benefits is the control of soil pests in vegetable and certain frm No effective
alternatives are available for control of these soil pests.
£. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the current use of
diazinon. Where labeling revisions are warranted, specific language is set form mine summary tables of
Section V.
42
-------
1. Human Health Risk Mitigation
a. Dietary Mitigation
(1) Dietary (Food)
Acute and chronic dietary risk fiom food alone is below the Agency's level of concern. No
mitigation is necessary.
(2) Drinking Water
Drinking water risk estimates based on a combination of screening level models and monitoring
data for ground and surface waters are also below the Agency's level of concern. No mitigation is
necessary for dietary risk from drinking water. In general, diazinon has been detected in ground water
fiwn a variety of sources including drinking water wells, mom Also,
diazinon is one of the most frequently detected insecticides in surface water in a NAWQA monitoring
program. However, the highest monitoring value cited is below the DWLOC, which indicates that the
screening level estimates are conservative. Furthermore, the Agency believes that the elimination of
residential uses, elimination of aerial applications, reduction in the dormant season use (almonds and
other orchard crops), and overall use reduction through other mitigation measures should reduce the
amount of diazinon found in ground water and surface water.
b. Occupational Risk Mitigation
(1) Agricultural Uses
The highest occupational risk for mixers, loaders, and applicators of diazinon is associated with
aerial applications because of the amount of product handled. Therefore, eliminating aerial applications
removes the handler scenario of greatest concern. Risks to mixers, loaders, and applicators for aerial
application are of concern even when engineering controls are factored into the assessment. Short term
ARIs (values above one are considered acceptable risk) for aerial application range from 0.037 to 0.30
for mixers/loaders and 0.074 to 0.59 for applicators. When cancellation was proposed to diazinon
users and stakeholders, the Agency did not receive any compelling benefits for aerial application. Most
diazinon is applied by ground equipment so the aerial prohibition will not pose an undue burden on
users.
Deletion of nearly all granular formulations also eliminates a worker scenario of potential concern.
Short term ARIs range from 024 to 0.90 for applicators. The range in ARIs is directly related to the
application rate (higher the rate, lower the ART). Granulars are basically used to control soil pests and
the application rate tends to be high (e.g., 4 Ib ai/acre). Given that diazinon liquid formulations are
registered for the same uses and pests, and with the same application rates, most occupational risk
associated with granulars is not justified by the benefits from their use.
43
-------
For handlers involved in ground application (the only remaining method of application for
diazinon), the use of engineering controls such as closed mixing/loading systems and closed cabs would
reduce risks from dermal and inhalation exposures to levds the Agency considers reasonable. To
achieve such risk reduction, the closed system must meet the requirements listed in the Worker
Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(dX4)], for dermal protection.
The system must be capable of removing the pesticide from the shipping container and transferring it
into mixing tanks and/or application equipment At any disconnect point, the system must be equipped
with a dry disconnect or dry couple shut-off device that is warranted by the manufacturer to minimize
dripping.
The level of protecticw resulting fh^ The
Agency is requiring worker exposure studies in order to qjiantify the additional pKrtectira tro^
engineering controls.
(2) Post-Application Risk
EPA has determined that short-term post application dermal exposures following typical use
patterns are associated with diazinon in occupational settings. Intermediate exposures are not
anticipated for post application workers. Current REIs tor diazinon are 24 hours tor font and nut
crops^ vegetable crops, and field crops and 12 hours for ornamentals. In order to reduce all re-entry
worker risks tor short term exposure, REIs are increased from 2 days (for root vegetables) to 1 8 days
(for nut trees). A range of typical label application rates and the assiimrtion that workers will be
exposed tor 8 hours/day (the upper bound for some activities) is used in the post application
assessment
One exception is the REI for almonds. Diazinon is applied to almonds only in the dormant
season, when no foliage is present The exposure route of concern for post application is dermal.
Based on these two reasons, the REI for almonds is seven days. The 18 day RBI remains for
hazelnuts, which has in season, foliar uses.
2. Environmental Risk Mitigation
Hiecurrent use of diazinon poses acute and chronic risks to birds and aquatic wildhfe. The
mitigation measures that are expected to lower expected risks to wildlife from use of diazinon are:
deletion of granular formulations, deletion of seed treatment use, deletion of aerial application, reduction
of aUowable applications for some crops, and deletion of foliar applications to vegetable crops. Ibis
mitigation will reduce, but rx* entirdy ehmmate risks to wildlne Ir^ Additionally, label
language will recommend that growers limit dormant season applications to orchards to every other
year.
44
-------
Because of their widespread use, deletion of granular formulations should have the most
significant impact on avian wildlife. Diazinon is highly toxic to birds. Hie assessed acute avian risk
quotients for granular formulations range from 1.08 to 4,725 (see section m B). Almost all granular
formulations are pre-plant, soil incorporated However, not all granules become incorporated, and
birds will also forage below the surface of the soil leading to the possible consumption of buried
granules.
Elimination of seed treatment willalso have an impact on avian wildlife. A diazinon treated seed
can contain 2.5 times the amount of diazinon found on a single 14G granule. A single diazinon 14G
granule could contain a toxic dose for song birds. Seeds are an attractive food source for birds.
While deleting aerial applications and reducing rate and number of applications do not directly
eliminate the assessed risks to wildlife, they do affect the potential for exposure. Deleting aerial
application will reduce drill to wildlife areas including water bodies adjacent to the field, and will also
lower the amount of area that may be treated at one time. Reduction in application rate and number of
applications will reduce total diazinon load to the ecosystem.
3. Other Labeling
In addition to the mitigation measures identified above, the Agency's interim decision
documented in this IRED is also based on the incorporation of other use and safety information into the
labeling of all end-use products containing diazinon. For the specific labeling statements, refer to
Section V of this document
4. 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 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 interim REDs into context for individual listed
species and their locations by evaluating important ecological parameters, pesticide use information, the
geographic relationship between specific pesticides uses and species locations, and biological
requirements and behavioral aspects of the particular species. This analysis will include consideration of
the regulatory changes recommended in this interimRED. A determination that there is a likelihood of
potential impact to a listed species may result in limitations on use of the pesticide, other measures to
mitigate any potential impact, or consultations with the Fish and Wildlife Service and/or the National
Marine Fisheries Service as necessary.
At present, the program is being implemented on an interim basis as described in a Federal
Register notice (54 FR 27984-28008, July 3,1989). A final program, which may be altered from fee
interim program, will be proposed in a Federal Register notice scheduled for publication in 2002.
45
-------
5. Spray Drift Management
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 aze 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/#20Ql). A Federal
Register notice was published on August 22,2001 (http://www.epa.gov/fedrgstr) mmnmvm^ the
availability of tins draft guidance for a 90-day public comment period. After receipt and review of the
comments, the Agency will publish final guidance in a PR notice for registrants to use when labeling their
products.
Until EPA decides upon, and publishes the final label guidance for spray and dust drift,
registrants (and applicants) may choose to use the statements proposed in the draft PR notice.
Registrants should refer to and read the draft PR notice to obtain a full understanding of flie fffoposed
guidance and its intended applicability, exemptions for certain products, and the Agency's willingness to
consider other versions of the statements.
For diazinon labels submitted in response to this document, registrants (and applicants) may
also elect to adopt the appropriate sections of the proposed language below, or a version mat is equally
protective, for their end-use product labeling.
For products applje4 outdoors as liquids (except mosquito adulticides):
"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."
'Tor ground boom applications, apply with nozzle height no more tnan 4 feet
above the ground or crop canopy, and when wind speed is lOmphorlessatthe
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."
'Tor orchard airblast applications, do not direct spray above trees,
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 an
anemometer outside of the orchard or vineyard on the upwind side."
For overhead chemigation:
"Apply only when wind speed is lOmphorless."
On all product labels:
"The applicator also must use all other measures necessary to control drift."
46
-------
Alternatively, registrants may elect to use the following language, which is fee current Agency policy on
drift labeling:
spraysL(except mo^qtqto
regardless of application method the following must be addedto fee labels:
**Do not allow tins 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 application methods.
V. What Registrants Need to Do
The Agency has deteimined that diazinon is e%liJe for reregistoadon (i)
additional data that the Agency intends to require confirm this interim decision; (ii) the risk mitigation
measures outlined in this document are adopted, and label amendments are made to reflect these
measures; and (Hi) cumulative risks considered for the organophosphates support a final ^registration
eligibility decision. 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 V.D below.
The additional data requirements that the Agency intends to obtain will include, among other things,
submission of the following:
A. f OfLjffflzspgp tstflPMCfld glUJff s^y^^S^Sd^P^l^^i^ registrants need
to submit the following items.
Within 90 days from receipt of the generic data calV-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 Stephanie Piummer at (703) 305-0076 with questions regarding generic
reregistrationandVortheDCI. All materials submitted in response to the generic DCI shouldbe
addressed:
47
-------
Ry T IS man-
Document Processing Desk (DCI/SRRD)
Stephanie Plummer
USEPA(7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service:
Document Processing Desk (DCI/SRRD)
Stephanie Plummer
Office of Pesticide Programs (7508C)
Room 266 A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
B. For products. Cflntajning the active mgtediq^t diaTinnn registrants need tn
submit the following items tor 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 fonn and
requirements status and registrant's response form); and
(2) submit any time extension or waiver requests with a fM writtm justification.
Within eight months from the receipt of the PDCI:
(1) two copies of the confidential statement of formula (EPA Form 8570-4);
(2) a completed original application for reregistration (EPA Form 8570-1).
Indicate on the form mat it is an "application for reregistration";
(3) five copies of the draft label incorporating all label amendments outlined in
Table 18 of this document;
(4) a completed form certifying compliance with data compensation requirements
(EPA Form 8570-34);
(5) if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
(6) the product-specific data responding to the PDCI.
Please contact Venus Eagle at (703) 308-8045 wilh questions regarding product reregistration
and/or the PDCI. All materials submitted in response to the PDCI should be addressed:
ByUSmafl:
Document Processing Desk (PDO/PRB)
Venus Eagle
USEPA(7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service only:
Document Processing Desk (PDO/PRB)
Venus Eagle
Office of Pesticide Programs (7508C)
Room266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
48
-------
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the leregistration of diazinon for the above eligible uses has
been reviewed and determined to be substantially complete. However the following data requirements
are necessary to confirm the interim reregjstration eligibility decision documented in mis IRED.
Toxicology
870.3250 90 - day repeated dose dermal study in rats.
Pmdoct Chemistry
. 830.6313 Stability
830.7050 UV/visible absorption
Additional product chemistry data for MUPs
Residue Chemistry
860.1500 Additional residue data required for blueberries, celery, spinach, and
Swiss chard.
Occupational Exposure
Worker exposure study associated wife "super* 'lock and laid systems including:
875.1100 . Dermal exposure
* 875.1300 Inhalation exposure
875.1500 Biological Monitoring.
Environmental Fate
835.1230 Mobility - adsorption and desorption studies.
835.1410 Laboratory volatility study.
835.6100 Terrestrial field dissipation information on diazoxon.
F.cnlogical Effects:
850.1400 Early rife-stage fish study for freshwater fish.
850.1500 Fish life cycle study for both freshwater and estaarine/marine species.
850.2100 Acute avian oral studies on the degradates, diazoxon and
oxypyrimidine.
850.2200 Subacute avian dietary studies on the degradates, diazoxon and
oxypyrimidine.
850.2300 Avian chronic tests on the degradates are reserved pending results of
the acute oral and dietary studies.
Also, a Data Call-In Notice (DCI) was recently sent to registrants of organophosphate
pesticides currently registered under FIFRA (August 6,1999 64FR42945-42947, August 18
64FR44922-44923). DCI requirements included acute, subchronic, and developmental neurotoxicity
studies. Protocols have been submitted to the Agency and the studies are in progress.
49
-------
2. Labeling for Manufacturing Use Products
To ensure compliance with FTFRA, 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 IS at the end of this section.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2XB) of FIFRA calls for the Agency to obtain any needed product-specific data
regaruing the pesticide after a de*eraiination of eligibility has been made. Registrants must review
previous data submissions to ensure that they meet current EPA acceptance criteria, and if not, commit
to conduct new studies. If a registrant believes that previously subniittied data ineet current testing
standards, then the study MRID numbers should be cited according to me 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 interim
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 Table 18.
C Existing Stocks
The Agency has determined that it is reasonable to allow the growers two years, except where
noted above, to adopt the mitigation measures outlined in this IRED. In other words, products bearing
the current labels/labeling may continue to be sold for two years.
D. Labeling Changes Summary Table
In order to be eligible for ^registration, amend all product labels to incorporate the risk
mitigation measures outiined in Section IV. The following table describes how language on the labels
should be amended.
50
-------
Table 18. Summary of Labeling Changes for Diazuion
,,,,,,,,,,,.,.,»_ ,^^ww-»^wvf**rpy~**u''' ,.,.,..,,o,,JU,«vl,,,.,»,,M.'i..w'»F.5.f.»»^
> X
Manufacturing Use Products
Formulation instructions
required on all MUPs
"Only for formulation into an insecticide for the following use(s) [insert only those uses that are being
supported by MUP registrant]. After December 31, 2005, this product may not be used to formulate any
end-use product labeled for application to mushrooms, including mushroom houses. After December 31,
2007, this product maynot be used to formulate any end-use product labeled for application to watercress.
After December 31, 2008, this product may not be used to formulate any end-use product labeled for foliar
application to melons, other than honeydew melons. Wettable powder formulations must be marketed in
water-soluble packaging. Granular formulations must be marketed in closed loading system (engineering
control) packaging. Granular formulations may be labeled for Section 3 product only for preplant soil-
incorporated applications to lettuce grown in California and Arizona. After December 31,2008, this product
may not be used to formulate any granular end-use product. In addition, Special Local Need (SLN)
registrations are active for granular use on cranberries in Oregon (OR970002), Washington (WA970001 and
WA900027), Massachusetts (MA970001), New Jersey (NJ970001), and Wisconsin (WI010001 and
WI980003). All other SLNs for granular products expire as soon as possible. The only Special Local Need
registrations for granular products allowed to continue after December 31,2008, are uses on cranberries in
Oregon (OR970002) and Washington (WA900027, and WA970001), or replacements thereof. After
December 31,2008, the Special Local Need registrations for cranberries in Massachusetts (MA970001), New
Jersey (NJ970001), and Wisconsin (WlOlOOOland WI980003) expire. Registrants should immediately contact
the issuing states about changing their SLN labels to reflect theupcoming expiration and should send a cop]
of the letter to ProductManager 13, Insecticide Branch, Registration Division (7505C) in EPA's Office of
Pesticide Programs."
Directions for Use
One of these statements may b
added to a label to allow
reformulation of the product fo
a specific use or all additional
uses supported by a formulate:
or user group.
"This product may be used to formulate products for specific use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission requirements regarding support
of suchuse(s)."
"This product may be used to formulate products for any additional use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission requirements regarding support
of suchuse(s)."
Directions for Use
Environmental Hazards
Statements Required by the
RED and Agency Label Policie
"This pesticide is highly toxic to birds, fish and aquatic organisms, and wildlife. Do not discharge effluent
containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance
with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and, the
permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing
this product to sewer systems without previously notifying the local sewage treatment plant authority.
For guidance, contact your State Water Board or Regional Office of the EPA."
Directions for Use
51
-------
End Use Products Intended for Occupational Use (WPS)
Restricted Use Pesticide
(excluding cattle ear tags)
"RESTRICTED USE PESTICIDE"
"Due to Avian and Aquatic Toxicity"
"For retail sale to and use only by Certified Applicators or persons under their direct supervision, and only
for those uses covered by the-Certified Applicator's certification."
Top of front panel.
Handler PPE considerations
Note the following information when preparing labeling for all end use products:
For sole active Ingredient end-use products that contain diazinon the product label must be revised to adopt
the handler personal protective equipment (PPE)/engineering control requirements set forth in this section.
Any conflicting PPE requirements on the current label must be removed.
For multiple active Ingredient end-use products that contain diazinon, the handler PPE/engineering control
requirements 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 PR Notice 93-7.
PPE that is established on the basis of Acute Toxicity testing with the end-use products must be compared
with the active ingredient PPE specified below in this document. The more protective PPE must be placed
in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
Precautionary Statements
Under PPE Requirements
52
-------
Handler PPE requirements for
wettable powder formulations ii
water soluble packaging and
liquid formulations
"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,
orH\ on an EPA chemical-resistance category selection chart."
"Mixers, loaders, applicators, and other handlers using engineering controls must wear:
Long-sleeved shirt and long pants
Shoes plus socks,
Chemical-resistant gloves, if mixing or loading
Chemical resistant apron, if mixing or loading
See engineering controls for additional requirements.
Handlers preforming tasks, such as cleaning equipment or spill clean-up, for which engineering controls are
not feasible must wear:
Coveralls over long-sleeved shirt and long pants,
Chemical-resistant gloves,
Chemical resistant shoes footwear plus socks,
Chemical-resistant apron, if exposed to the concentrate.
A 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 organic vapor (OV) cartridge or canister
with any N, R or P or HE prefilter."
(Note: Drop the N type prefilter from the respirator statement if the pesticide product contains or is used
with oil.)
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
53
-------
Handler FPE requirements for
granular formulations in closed
loading (engineering control)
system 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 AJl,C,D,E,F,
G or /fl on an EPA chemical-resistance category selection chart."
"Mixers, loaders, applicators, and other handlers using engineering controls must wear:
Long-sleeved shirt and long pants
Shoes plus socks,
Chemical-resistant gloves, if loading
Chemical-resistant apron, if loading
See engineering controls for additional requirements.
Handlers preforming tasks, such as cleaning equipment or spill clean-up, for which engineering controls are
not feasible must wear:
Coveralls over long-sleeved shirt and long pants,
Chemical-resistant gloves,
Chemical resistant footwear plus socks, and
A 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 organic vapor (0V) cartridge or canister
with any N, R or P or HE prefilter."
Immediately following/below!
Precautionary Statements:
Hazards to Humans and
Domestic Animals
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables
exist, use detergent and hot water. Keep and wash PPE separately from other laundry."
"Discard clothing and other absorbent materials that have been drenched or heavily contaminated with this
product's concentrate. Do not reuse them." __ ___^^_
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following the
PPE requirements
54
-------
Engineering Controls
for liquid formulations (Except
as specified, all mixers, loaders,
applicators, and flaggers must
use engineering controls to mix
load, and apply diazinon
products.)
"Engineering Controls:
Mixers and loaders must use a closed system that meets the requirements listed in the Worker Protection
Standard (WPS) for agricultural pesticides that provides dermal and inhalation protection [40 CFR
170.240(4X4)], and must:
wear the personal protective equipment required for mixers/loaders using engineering controls;
-- wear protective eyewear, if the system operates under pressure; and
be provided and have immediately available for use in an emergency, such as a broken package,
spill, or equipment breakdown, chemical-resistant footwear and the respirator specified in the PPE
section of this labeling for handlers not using engineering controls.
Applicators using motorized ground equipment and flaggers supporting aerial applications to lettuce 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, applicators must:
- wear the personal protective equipment required in the PPE section of this labeling for
handlers using engineering controls;
- after wear the respirator specified for handlers not using engineering controls 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 respirator specified for handlers not using
engineering controls;
be provided, and have immediately available for use in an emergency when they must exit the
cab in the treated area, coveralls, chemical-resistant footwear and - if not already using one -
the respirator specified for handlers not using engineering controls;
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.
EXCEPTION: For applications to apples and lettuce, see directions for use for a special exception to these
engineering controls requirements.
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 entering or leaving an aircraft
contaminated with pesticide residues, pilots must wear chemical-resistant gloves and must store used
gloves in a chemical-resistant container, such as a plastic bag, to prevent contamination of the inside of the
cockpit.
Note: aerial applications are permitted only on lettuce."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following the
User Safety Requirements.
55
-------
Engineering Controls
for wettable powder (WP)
formulations in water-soluble
packaging (Except as specific*
all mixers, loaders, applicators,
and flaggcrs must use
engineering controls to mix, Ion t
and apply diazinon products.)
"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 the personal protective equipment required for mixers/loaders using engineering controls;
and
-- be provided and must have immediately available for use in an emergency, such as a broken
package,spill, or equipment breakdown, chemical-resistant footwear and the respirator specified
for handlers not using engineering controls.
Applicators using motorized ground equipment and flaggers supporting aerial applications to lettuce 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, applicators must:
wear the personal protective equipment required in the FPE section of this labeling for handlers
using engineering controls;
-- either v/caT the respirator specified for handlers not using engineering controls wuse 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 respirator specified for handlers not using
engineering controls;
-- be provided, and have immediately available for use in an emergency when they must exit the
cab in the treated area, coveralls, chemical-resistant footwear and - if not already using one -
the respirator specified for handlers not using engineering controls;
- 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.
EXCEPTION: For applications to apples and lettuce, see directions for use for a special exception to these
engineering controls requirements.
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 entering or leaving an aircraft
contaminated with pesticide residues, pilots must wear chemical-resistant gloves and must store used
gloves in a chemical-resistant container, such as a plastic bag, to prevent contamination of the inside of the
cockpit.
Note: aerial applications are permitted only on lettuce."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following the
User Safety Requirements.
56
-------
Engineering Controls for
granular formulations (Except a
specified, alt loaders and
applicators must use engineerii
controls to load and apply
diazinon products.)
"Engineering Controls
This product is formulated into a (registrant to insert the trade name of the closed system in wfifcA the product
$s marketed) system that meets the definition of a closed loading system in the Worker Protection Standard
for Agricultural Pesticides [40 CFR 170.240(d)(4)]. Loaders using the closed loading system packaging must
-- wear the personal protective equipment required for loaders using engineering controls; and
be provided and must have immediately available for use in an emergency, such as a broken
package,spill, or equipment breakdown, chemical-resistant footwear and the respirator specified
for handlers not using engineering controls.
Applicators using motorized ground equipment must use an enclosed cab that meets the definition in the
Worker Protection Standard for Agricultural Pesticides [40 CFR 170.240(d)(5)J for dermal protection. In
addition, applicators must:
wear the personal protective equipment required in the PPE section of this labeling for handlers
using engineering controls;
either wear the respirator specified for handlers not using engineering controls 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 respirator specified for handlers not using
engineering controls;
- be provided, and have immediately available for use in an emergency when they must exit the
cab in the treated area, coveralls, chemical-resistant footwear and - if not already using one -
the respirator specified for handlers not using engineering controls;
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."
EXCEPTION: For applications to lettuce, see directions for use for a special exception to these engineering
controls requirements.
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following the
User Safety Requirements.
User 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
ctean clothing.
Users should remove PPE immediately after handling this product. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary Statements
under: Hazards to Humans
and Domestic Animals
immediately following
Engineering Controls
(Must be placed in a box.)
57
-------
Environmental Hazards (liquid
and wettable powder products]
Environmental Hazards
"This product is highly toxic to birds, fish and other wildlife. Birds, especially waterfowl, feeding or
drinkingon treated areas may be killed. Do not exceed maximum permitted label rates. Rates above those
recommended significantly increase potential hazards to birds, especially waterfowl. Keep out of lakes,
streams, ponds, tidal marshes and estuaries. Do not apply directly to water, 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 neighboring areas. Shrimp and crab may be killed at application rates recommended
on this label. Do not apply where fish, shrimp, crab, and other aquatic life are important resources. Do
not contaminate water by cleaning of equipment or disposal of equipment wash water. This pesticide is
highly toxic to bees exposed to direct treatment or to residues on blooming crops or weeds. Do not apply
this pesticide or allow it to drift to blooming crops or weeds if bees are visiting the treatment area."
Precautionary Statements
immediately following the
User Safety
Recommendations
Environmental Hazards
(granular products)
Environmental Hazards
"This product is highly toxic to birds, fish and other wildlife. Birds, especially waterfowl, feeding or
drinkingon treated areas may be killed. Do not exceed maximum permitted label rates. Rates above those
recommended significantly increase potential hazards to birds, especially waterfowl. Avoid overlapping
granules. Collect or incorporate granules that are spilled during loading or are visible on soil surface in
turn areas. Keep out of lakes, streams, ponds, tidal marshes and estuaries. Do not apply directly to water,
to areas where surface water ispresent, or to intertidal areas below the mean high water mark. Drift and
runoff may be hazardous to aquatic organisms in neighboring areas. Shrimp and crab may be killed at
application rates recommended on this label. Do not apply where fish, shrimp, crab, and other aquatic life
are important resources. Do not contaminate water by cleaning of equipment or disposal of equipment wash
water.
58
-------
General Application
Restrictions
"Do not apply this product in a way that will contact workers or other persons, either-directly or through
drift. Only protected handlers may be in the area during application."
Place in the Directions for
Use directly above the
Agricultural Use Box.
Early Re-entry Personal
Protective Equipment
established by the RED
"PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and
that involves contact with anything that has been treated, such as plants, soil, or water, is:
- coveralls worn over long-sleeve shirt and long pants,
- chemical-resistant gloves made of any waterproof material,
- chemical-resistant footwear plus socks, and
- chemical-resistant headgear, if overhead exposures."
Directions for Use,
Agricultural Use
Requirements Box
Notification Requirements
"Notify workers of the application by warning them orally and by posting warning signs at entrances to
treated areas."
Directions for Use,
Agricultural Use Application
Restrictions Labels must be
amended to reflect the
following application
restrictions which supersede
or are in addition to, Place in
the Directions for Use under
Application Instructions for
Each Crop.
59
-------
Application Restrictions
Applet:
Delete: all pests and directions for use except for Woolly Apple Aphid and San Jose Scale.
Add:
- "Maximum of two applications per year, either one dormant and one foliar application, or two foliar
applications."
- "EXCEPTION for Airblast Applications to Apples: When application using enclosed-cab airblaat
equipment is not feasible in apple orchards, applicators are permitted to use open-cab airblast equipment,
PROVIDED they are wearing chemical-resistant headgear AND the personal protective equipment specified
in this labeling for handlers not using engineering controls ."
- "REI is 4 days."
Apricots:
Delete: all references to multiple applications per season.
Add:
- "Maximum of one application during the growing season. Apply every other year, unless pest infestation
can be controlled only with consecutive annual treatments."
~ "Maximum of one application during the dormant season."
-"REI is 4 days."
Blueberries:
Delete: all references to multiple applications per season.
Add:
- "Maximum of one application per year for foliar pests."
- "Maximum of one application per year for fire ant control."
-"REI is 5 days."
Caneberrles:
Delete:
-- all pests except Raspberry Fruitworm and Raspberry Crown Borer;
all references to multiple applications per season.
Add:
- "Maximum of one application per year."
- "REI is 5 days."
Place in the Directions for
Use under Application
Instructions for Each Crop.
60
-------
Application Restrictions
Cherries:
Delete:
Directions for a single supplemental post-harvest spray.
Add:
~ "Maximum of one application doting the growing season. Apply every other growing season, unless
pest infestations can be controlled only with consecutive annual treatments."
- "Maximum of one application during the dormant season."
-"REIis4days."
Cranberries:
Liquid formulations
Delete: any reference that allows more than three applications per growing season.
Add:
- "Maximum of three applications per year."
-"REIisSdays."
Granular formulations (SLN registrations)
Delete: any reference that allows multiple applications per growing season.
Add:
-"Maximum of one application peryear."
-"REIisSdays."
- The current Section 24(c) Special Local Need (SLN) registrations in Massachusetts (MA970001), New
Jersey (NJ970001), and Wisconsin (WI010001, and WI980003) will expire after December 31,2008. Only
the current registrations in Oregon (OR970002) and Washington (WA900027, and WA970001) will be
allowed to continue after December 31,2008. Registrants should contact the issuing state about changing
their SLN labels to reflect the upcoming expiration and should send a copy of the letter to Product Manager
13, Insecticide Branch, Registration Division (7505C) in EPA's Office of Pesticide Programs.
Figs:
Delete: all references to multiple applications per season.
Add:
~ "Maximum of one application per year."
-"REIis4days."
Place in the Directions for
Use under Application
Instructions for Each Crop.
61
-------
Filberts (Hazelnuts):
Delete: all references to multiple applications per season.
Add:
- "Maximum of one application per year."
-"REI is 18 days."
Nectarines, Peaches:
Delete: all references to multiple applications per season.
Add:
~ "Maximum of one application during the growing season. Apply every other year, unless pest
infestations can be controlled only with consecutive annual treatments."
- "Maximum of one application during the dormant season."
- "REI is 4 days,"
Ornamentals:
Change: maximum application rate from 2 Ib ai/A to 1 Ib ai/A.
Delete: all references to multiple applications per season.
Add:
- "Maximum of one foliar application per crop."
- "REI is 7 days for flowers and other commercial ornamentals grown for cutting."
- "REI is 2 days for all other commercial ornamentals."
- Application is permitted only on commercial ornamentals grown outdoors in nurseries.
Pears:
Delete: all references to multiple applications per season.
Add:
- "Maximum of one application during the growing season. Apply every other year, unless pest
infestations can be controlled only with consecutive annual treatments."
- "Maximum of one application during the dormant season."
-"REI is 4 days."
62
-------
Pineapples:
Add:
- "Maximum of two applications per year."
-"REIis4days."
Plums/Prunes:
Delete: all references to multiple applications per season.
Add:
- "Maximum of one application during the growing season. Apply every other year, unless pest
infestations can be controlled only with consecutive annual treatments."
- "Maximum of one application during the dormant season."
- "REI is 4 days."
Strawberries:
Delete: all references to multiple applications.
Add:
- "Maximum of one foliar application per crop."
- "Maximum of one soil application per crop."
- "REI is 3 days."
63
-------
Application Restrictions
Brans (Snccalent), Beets (Red), Broccoli, Brussels Sprouts, Cabbage, Carrots, Cauliflower, Collards,
Endive, Kale, Mustard Greens, Onions, Peas (Succulent), Radishes, Rutabagas, Spinach, Tomatoes:
Delete:
- all foliar pests and associated directions for use, including PHIs.
- all references to multiple applications.
Add:
- "Maximum of one soil application per year."
-"REI is 3 days for beans."
- "REI is 3 days for beets (red)."
- "REI is 4 days for broccoli."
- "REI is 4 days for Brussels sprouts."
- "REI is 4 days for cabbage."
- "REI is 3 days for carrots."
- "REI is 4 days for cauliflower."
- "REI is 4 days for collards."
- "REI is 4 days for endive."
- "REI is 4 days for kale."
- "REI is 4 days for mustard greens."
- "REI is 3 days for onions."
- "REI is 3 days for peas."
- "REI is 3 days for radishes."
- "REI is 4 days for rutabagas,"
- "REI is 3 days for spinach."
- "REI is 2 days for tomatoes."
Place in the Directions for
Use under Application
Instructions for Each Crop.
64
-------
Description ^ ^ V
Application Restrictions
Ginseng
Delete:
- all soil pests and associated directions for use.
- all references to multiple applications.
Add:
- "Maximum of one foliar application per year."
- "REI is 3 days."
Lettuce:
Liquid and Wettable Powder formulations:
Change maximum application rate from 4 Ibs ai/A to 2 IDS ai/A.
Add:
- "Maximum of one foliar application per crop."
- "Aerial application is permitted."
- "EXCEPTION for Lettuce: applicators applying to lettuce are permitted to use open-cab equipment, PROVIDED
they are wearing chemical-resistant the personal protective equipment specified in this labeling
for handlers not using engineering controls."
-"REI is3 days."
Granular Formulations (California and Arizona only)
Change maximum application rate from 4 Ibs at/A to 2 Ibs ai/A.
Add:
- " Maximum of one at-plant soil application per crop."
- "EXCEPTION for Lettuce: applicators applying to lettuce are permitted to use open-cab equipment, PROVIDED
they arc wearing chemical-resistant the personal protective equipment specified in this labeling
for handlers not using engineering controls."
-"REIis3days."
Place in the Directions for
Use under Application
Instructions for Each Crop.
65
-------
Application Restrictions
Melons:
For melons:
Add:
- "Maximum of one soil application per year."
- "Maximum of one foliar application per year."
- "REI is 3 days."
Watercress:
Add:
"Maximum of one foliar application per season."
- "REI is 4 days."
Trunk Wraps:
On labels that contain use directions for trunk wraps, add:
- "Use limited to commercial agriculture and horticulture only. Use in residential settings is prohibited."
gj~ ,*;,,
Place in the Directions for
Use under Application
Instructions for Each Crop.
Use Deletions
Chinese Broccoli, Chinese Cabbage, Chinese Mustard, Chinese Radish, Corn, Grapes, Hops, Sugar
Beets, Walnuts:
Delete all of the above uses from labels for liquid or wettable powder products.
Beets (red, table), Broccoli* Brussels Sprouts, Cabbage, Carrots, Cauliflower, Collards, Endive
(Escarole), Ginseng, Kale, Melons, Mustard, Onions (bulb, green), Radishes, Spinach, Sugar Beets,
Sweet Corn, Tomatoes:
Delete all of the above uses from labels for granular products.
Seed Treatment Uses:
Delete all seed treatment uses, including beans (snap, lima), corn (field, sweet), and peas (green).
Use Deletions
66
-------
Application Restrictions on
Section 24 (c) - Special Local
Needs labels.
SPECIAL LOCAL NEEDS LABELS:
Celery, Cucumbers, Parsley, Parsnips, Peppers, Irish Potatoes, Squash (winter and summer), Sweet
Potatoes, Swiss Chard, Turnips (roots and tops):
Delete:
~ all foliar pests and associated directions for use.
~ all references to multiple applications.
Add:
- "Maximum of one soil application per growing season."
- "REI is 3 days for celery."
- "REI is 3 days for cucumbers."
-"REI is 3 days for parsley."
- "REI is 2 days for peppers."
- "REI is 3 days for Irish potatoes."
- "REI is 3 days for sweet potatoes."
- "REI is 3 days for Swiss chard."
- "REI is 3 days for turnips (roots and tops)."
-"REI is 3 days for parsnips."
The following SLN uses/registrations will not be allowed to continue:
- Dipping of pineapple seed pieces (HI770010 and HI970005).
- Grass grown for seed (OR880001).
- AH uses of granular formulations, except the cranberry uses (described under application restrictions to
cranberries) in Massachusetts, New Jersey, Wisconsin, Oregon, and Washington.
Registrants should immediately contact the issuing states about the expiration and send a copy of the
letter to Product Manager 13, Insecticide Branch, Registration Division (7505C) in EPA's Office of
Pesticide Programs.
Place in the Directions for
Use under Application
Instructions for Each Crop.
Spray Drift Labeling
[Note to registrants: The Agency is currently working with stakeholders to develop appropriate generic
label statements to address spray drift risk. Once this process has been completed, diazinon product
labels
will need to be revised to include this additional language. No labeling changes with respect to drift are
needed
at this time.}
Directions for Use in
General Precautions and
Restrictions
67
-------
Instructions in the Labeling section appearing in quotations represent the exact language that should appear on the label. Instructions in the Labeling section not in quotes
represents actions that the registrant should take to amend their labels or product registrations.
68
-------
VI. Related Documents and How to Access Them
This interim Reregistration Eligibility Document is supported by documents that are presently
maintained in the OPP docket The OPP docket is located in Room 1 19, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday, excluding legal holidays
from 8:30 am to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of May
19,2000. Sixty days later the first public comment period closed. The EPA then considered
comments, revised the risk assessment, and added the formal "Response to Comments" document and
the revised risk assessment to the docket on December 5, 2000.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site:
http:#www.epa
htm
69
-------
70
-------
VH. APPENDICES
71
-------
72
-------
Appendix A. Food/Feed Use Patterns Subject to Reregistration for Diazinon (Case 0238).
Site -
Application Type
Application "Rising ~
Applicatton Equipment
Max. Single Appficanon
Rate?*
tt)
Max. -It Anus, e
Mioisfiim ,
Retreatment
latervaHBays)
Use
Food/Feed Crop Uses
Almonds ( onlv m CAi
Broadcast dormant application
Ground equipment
Apples
Broadcast foliar application
Ground equipment
Apricots
Broadcast dormant
application
Ground equipment
Bananas
Broadcast foliar application
Ground equipment
Beets, Red
Broadcast pre-plant soil
incorporated
Ground eouinment
Blaeberries
Broadcast foliar application
Ground equipment
Fire-ant mound application
Ground equipment
Broccoli
Broadcast pre-plant soil
incorporated
Ground equipment
Brussels Soronts
Broadcast pre-plant soil
incorporated
Ground equipment
Cabbage
Broadcast pre-plant soil
incorporated
Ground eouipment
3lb/A
21b/A
i
i
2Ib/A
i
Not applicable
(NA)
14
NA
(xsib/A
4Ib/A
0.5 IWA
0.51b/A
41b/A
41b/A
41b/A
6
1
1
1
1
1
1
7
NA
NA
NA
NA
NA
NA
A PHI is not specified.
Do not apply more than 3 Ib ai/
Dormant season only.
A 21-day PHI is specified.
Do not apply more than 2 Ib ai/
Use only to control woory appi
A 21-day PHI is specified.
Do not apply more man 2 Ib ai/
Dormant season only
A 28-day PHI is specified.
Use large droplet producing no
Special local needs label for Hv
A 14-day PHI is specified.
A 7-day PHI is specified.
Do not apply more man t Ib ai
A 7-day PHI is specified.
A 7-day PHI is specified.
A 2 1-day PHI is specified.
Caneberries (Blackberries, Boyseaberries, Dewberries. Loganberries, Raspberries) ( onlv in CA, OR, aad WA)
Broadcast dormant application
Ground eourafflent
21b/A
1
NA
A 7-day PHI is specified.
73
-------
Site ' ' ' ' '. -. . '.. . ' " ' '
Application Type
Application Timing
Application Eqmpment :
Carrota
Broadcast pre-plant soil
incorporated
Ground eouranent
Cauliflower
Broadcast pit-plant soil
incorporated
Ground ecnriwnent
Celery
Broadcast pn-pJant soft
incorporated
Ground equipment
Max. Singk Application
Rate**
(ai)
4 ft/A
41b/A
4 ft/A
Max. # Apps, c
I
1
1
. : Minimum
Re&eatmeo!
Intwval (Days)
NA
NA
NA
Use
A 2 1-day PHI is specified.
A 7-day PHI is specified.
Special Local Needs labels
74
-------
Site V d '.'. ' ' :.
Application Type
Application Timing ^
Application Equipment
Cherries
Broadcast dormant application
Ground equipment ^
Broadcast foliar application
Ground equipment
CollardS
Broadcast pie-plant soil
incorporated
Groond equipment
Jtfax. $n$e_£|»gjicatiQn
RateT*
^ai>
- Ma3L#Apps,c
2fo/A
21b/A
4IWA
I
1
1
Minimum
Retraatmem
Inierval f Days)
NA
NA
NA
Un
A 21 -day PHI is specified.
Bo-not apply more man 4 Ib ai
A 1 0-day PHI is specified.
Do not apply more than 4 Ib ai/
Special Local Needs label for Tc
Cranberries (Oregon and WftSBraetoo)
Broadcast foliar application
Ground equipment
Granular formulation
Broadcast foliar application
Ground equipment
Cncumbers
Broadcast pie-plant soil
incorporated
Ground equipment
Endive (Escarde)
Broadcast pre-plant soil
incorporated
Ground equipment
2or31h/A
3Ib/A
4fc/A
4fo/A
Figs
Broadcast foliar application
Ground eouipment
Filberts
Broadcast foliar application
Ground equipment
0.5 1WA
0.51b/A
3
I
I
1
1
1
Ginseng
Broadcast foliar application
Ground equipment
Kale
Broadcast pre-plant soil
incorporated
Ground equipment
0.5Ib/A
4Ib/A
1
1
14
NA
NA
NA
NA
NA
NA
NA
A 7-day PHI is specified.
Do not apply more than 12 Ib a
Use is on Special Local Needs 1
Ground applications include era
systems; no other type of irrig£
For granular formulation: assun
watered by sprinkler irrigation c
A 7-day PHI is specified.
Special Local Needs labels
A 14-day PHI is specified.
A 30-day PHI is specified.
Do not apply during flowering
Do not graze treated areas or fe
A 10-day PHI is specified.
Special Local Needs label forTc
75
-------
Site
Application Type
Application Timing
Application Equipment
Lettace
Broadcast pre-plant soil
incorporated
Ground eaubment
Lettace (CaHforaia only)
Broadcast pie-plant soil
incorporated
Ground eouipment
Broadcast foliar application
Ground equipment
Granular use
Broadcast pre-plant soil
incorporated
Ground equipment
Max. Single Application
Rate**
Cai)
4Ib/A
4 ft/A
0.5 Ib/A
lib/A
Max. # ADOS. c
1
1
1
1
Melons
Broadcast pre-plant soil
incorporated
Ground eouiotnent
Honevdew Melons (California onrv)
Broadcast foliar application
Ground equipment
Mustard
Broadcast pre-plant soil
incorporated
Ground eouimnent
Nectarines and Peaches
Broadcast dormant application
Ground equipment
Broadcast foliar application
Ground eaunnnent
Onions (bulb and green)
Broadcast pre-plant soil
incorporated
Ground eouimnent
Parslev
Broadcast pre-plant soil
incorporated
Ground equipment
4 ft/A
0.75 Ib/A
41b/A
2 Ib/A
2 In/A
4 Ib/A
4 Ib/A
1
l
1
1
1
1
1
Minimum
Bfitreatraent
Interval (Days)
NA
NA
NA
NA
Use
A 14-day PHI is specified.
A 14-day PHI is specified.
Do not apply more man 4.5 Ib i
Foliar applications are allowed
phased out in 2007.
If granular is used pieplant, do
Granular use is allowed in Calil
2007.
NA
NA
NA
NA
NA
NA
NA
A 3-day PHI is specified.
A 3-day PHI is specified.
A 10-day PHI is specified.
Special Local Needs label for Tt
A 2 1-day PHI is specified.
Do not apply more man 4 Ib ai
A 14-day PHI is specified.
Special Local Needs labels
76
-------
Site _ _ , _
Application Type ,
Application Timing , ;
Application Equipment :
Pears
Broadcast dormant application
Ground equipment
Broadcast foliar application
Ground equipment
Peas (succulent oaM
Broadcast pre-plant soil
incorporated
Ground equipment
Max . Single Application
; -jut***
r" 4»)
2fo/A
2ItVA
41b/A
Peooen
Broadcast pre-plant soil
incorporated
Ground eouioment
4Ib/A
. 'Max.-* Apps, *
1
1
1
1
Minimum
Retreatmeut
'Interval (Days)
NA
- NA
Use
A 21-day PHI is specified.
Do not apply more man 4 Ib ai
NA
NA
A 7-day PHI is specified.
Vines and hay may be fed to da
PHI is specified if forage is to t
Special Local Needs labels
A 5-day PHI is specified.
Pineapples
Broadcast foliar application
Ground eoiUDment
lib/A
2
28
A 7-day PHI is specified.
Do not arolv more than 2 Ib ai/
Plums and Prunes
Broadcast dormant or foliar
application
Ground equipment
Broadcast foliar application
Ground eouioment
Potatoes
Broadcast pre-plant soil
incorporated
Ground equipment
Radishes
Broadcast pre-plant soil
incorporated
Ground equipment
21b/A
2Ib/A
41b/A
4Ib/A
Rvtabaeas
Broadcast pre-plant soil
incorporated
Ground equipment
Spinach
Broadcast pre-plant soil
incorporated
Ground equipment
41b/A
4Ib/A
1
1
1
1
1
1
NA
NA
NA
NA
A 2 1 -day PHI is specified.
Do not apply more than 4 Ib al
A 35-day PHI is specified.
Special Local Needs labels
A 14-day PHI is specified.
Special Local Needs label for T<
NA
NA
A 14-day PHI is specified.
A 14-day PHI is specified.
Special Local Needs label for T(
Sauash. Summer
77
-------
Site
Application Type
Application Timing
Application Equipment
Broadcast pre-plant soil
incorporated
Ground eouimnent
Squash. Winter
Broadcast pre-plant soil
incorporated
Ground equipment
Strawberries
Broadcast pre-plant soil
incorporated
Ground equipment
Broadcast foliar application
Ground eouiranent
Sweet Potatoes
Broadcast pre-plant soil
incorporated
Ground equipment
Swiss Chard
Broadcast pre-plant soil
incorporated
Ground equipment
Tomatoes
Broadcast pre-plant soil
incorporated
Ground eouroment
Turnips, Roots and Tops
Broadcast pre-plant soil
incorporated
Ground equipment
Max, Single Application
Rate"*
(al
4fo/A
4 ft/A
lib/A
lib/A
4Ib/A
Max. # Apps. c
1
Minimum
Retreatment
Interval (Days)
NA
1
NA
1
1
1
41b/A
1
4Ib/A
4Ib/A
1
1
NA
NA
NA
NA
NA
NA
Use
A 7-day PHI is specified
Special Local Needs labels
A 3-day PHI is specified.
Special Local Needs labels
A 5-day PHI is specified.
Do not apply more man 2 Ib ai/
A 14-day PHI is specified.
Special local needs label for Tex
A 1-day PHI is specified.
A 14-day PHI is specified.
Special local needs labels
Available formulations are 50% Wettable Powder (EPA Reg # 100-460), 4 Ib/gal EC (EPA Reg # 100-461), and 4.5
Ih/gal SCI (EPA Reg # 100-784).
Granular formulation 14% G [EPA Reg # 100-469] is available for use on lettuce only. Granular formulation 14% G
(EPA Reg #s NJ9500IO. OR930006, and MA83Q00500) are available for use on cranberries only.
For use on pears and pineapples only me 50% WP [EPA Reg # 100-460] is available.
Maximum number of applications at die maximum single application rate.
Other use limitations such as the mminmm amount of water used for each application and re-entry interval restrictions are
not listed in this table.
78
-------
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Registration Decision
GUIDE TO APPENDIX B
Appendix B contains a listing of data requirements which support the reregistration for active
ingredients within fee case EPTC covered by mis RED. It contains generic data requirements that
apply EPTC 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. Pfltfl recrement (Column 1). The data requirements are listed in the order in which they appear in
40CFRpart 158. The reference numbers accompanying each test refer to the test protocols set in
the Pesticide Assessment Guidance, which is available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161. (703) 487-4650.
2. Use Patern (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 teed
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
79
-------
3. Bibliographic Citation fCohmm 3). If me Agency has acceptable data in its files, this column lists
the identifying number of each study. Thisnormally is the Master Record Identification (MRID)
number, but may be a "GS" number if no MRID number has been assigned Refer to the
Bibliography appendix for a complete citation of the study.
Appendix B. Data Supporting Guideline Requirements for the Reregistration of Diazinon
NewGuidetine
Number
Otd Guideline
.. . Description
Number r
UK fMttan
Citation/s)
PRODUCT CHEMISTRY
830.7050
830.6313
None
63-13
LJV/Visible Absorption
Stability
All
All
Data Gap
Date Gap
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2400
850.2300
850.2300
850.1075
850.1075
850.1010
None
850.1025
850.1035
850.1300
71-l(a)
71-l(b)
71-2A
71-2B
71-3
71-4A
71-4B
72-1A
72-1C
72-2A
72-3A
72-3B
72-3C
72-4A
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Wild Mammal Toxicity
Avian Reproduction - Quail
Avian Reproduction - Duck
rish Toxicity Bluegtll
rish Toxicity Rainbow Trout
nvertebrate Toxicity
iStuarine/Marme Toxicity - fish
istuarine/Marine Toxicity - Mollusk
oyster)
istuarine/Marine Toxicity - Shrimp
Fish- Early Life Stage
ABCJO
ABCJO
ABCJ
ABCJ
ABCJ
ABCJ
ABO
ABCJO
ABCJO
ABCJ
ABCJ
ABCJ
ABCJ
00103959, 0020560, 0160000,
00109015, 40895303, 40895309,
40895305, 40895306, 40895307,
Data Gap for degradates1
00034769, Data Gap for
degradates1
0160000, 40895302, 40895301,
40895305, 40895307, 00034769,
40895308, 00103959, Data Gap
for degradates1
00238762, 00146179, 41407202,
41407210, 41332609, 41332616,
41 137003, 43543901, 41580201,
41535201,41577401,41514701,
41511001
41322902, data reserved for
degradate1
41322901, 104083, data reserved
for degradate2
40910904, 40509802, 40509801,
00103960
00103959
40509803, 00109022
40228401,40914801
40625502
40625501
40914801,44244802
80
-------
New Guideline
Number ,
850.1350
850.1400
850.1500
850.4100
850.4150
850.4400
850.4225
850.4250
850.4400
8503020
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.6100
870.3200
8703250
870.6200
870.4100
870.4100
870.4200
870.4200
8703700
8703700
8703800
870.5300
870.5375
870.5915
QldGsideKiie _ ._.
- , . PesenptiQs
Number , ,
72-4B
72-4C
72-5
122-1A
122-1B
122-2
123-1A
123-IB
123-2
141-1
81-1
81-2
81-3
81-4
81-5
81-6
81-7
82-2
82-3
82-7
83-1A
83-1B
83-2A
83-2B
83-3A
83-3B
83-4
84-2
84-2B
84-2
Estuarine/Marine Invertebrate Life
Cycle
Bariy Life-Stage Freshwater Fish
Fish Life Cycle Study
r errestral Plant Toxicity, Tier 1
'Seedling Emergence)
rerrestrial Plant Toxicity, Tier 1
Vegetative Vigor)
Aquatic Plant Growth
Seedling Germination and Seedling
Emergence, Tier 2
''ton-target Terrestrial Plant
Phytotaxicity
Aquatic Plant Growth
Honey Bee Acute Contact
TOXICOLOGY
Acute Oat Toxicity-Rat
Acute Dermal Toxicity-Rabtat/Rat
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
Acute Delayed Neurotoxicity - Hen
21-Day Dermal - Rabbit/Rat
90-day Subchronk Dermal Toxicity
Test, Rat
Subchronic Neurotoxicity Study
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity -Non-Rodent
Oncogenicity - Rat
)ncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generatkm Reproduction - Rat
Gene Mutation Mammalian Cell
Structural Chromosomal Exchange
[n Vivo Sister Chromatid Exchange
UK Pattern
ABCJ
ABCJ
ABCJ
ABCJ
ABCJ
ABCJ
ABCJ
ABCJ
ABCJ
ABCJ
Ciiatioitfs)
44244801
Data Gap
Data Gap
40509805
40509804
40509806
40803001
40803002
40509806
05004151
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
41407218
41407219
41407220
41407221
41407222
41407223, 00232008
44132701
40660807
45184305, Date Gap
43549302, 43543901
41942002
41942001
00073372
00073372
00153017
00079017
41158101
41557404, 40660802, 41 1 19701
40660805,41603201
41577301,43060601,41687701,
41557405
81
-------
New&udeline
Nfflnber
870.6200
870.7485
870.8700
875.2100
875.2400
875.2500
875.1100
875.1300
875.1500
Old Guideline _, _
fc, , DeseriptioB
Number
81-1A
85-1
None
132-1A
133-3
133-4
231
232
235
Acute Neurotoxicity Screening Battery
Rat
General Metabolism
Subchrauc Oral Toxichy Test
UM Pattern
ABCJO
ABCJO
ABCJO
OCCUPATIONAL/RESIDENTIAL EXPOSURE
Foliar Residue Dissipation
Dennal Passive Dosimetiy Exposure
Inhalation Passive Posimeuy Exposure
Estimation of Dermal Exposure at
Outdoor Sites
Estimation of Inhalation Exposure at
Outdoor Sites
biological Monitoring
ABCJ
ABCJO
ABCJO
ABCJO
ABCJO
ABCJO
CHation(s)
43132201,43132204,43132203,
44219301
41108901
40815004
44959101
44348801,44959101
45184305,44959101
44972201, 44405802, Data Gap
44405802, 44972201, Data Gap
Data Gap
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.4100
835.4200
835.1230
835.1410
835.6100
161-1
161-2
161-3
162-1
162-2
163-1
163-2
164-1
Hydrolysis
Pnotodegredation - Water
Pbotodegredation - Soil
\erobic Soil Metabolism
Anaerobic Soil Metabolism
Leaching/ Adsoiption/Desoiption
Laboratoiy Volatilization (from Soil)
Study
reirestrial Field Dissipation
ABCJ
ABO
ABCJ
ABCJ
ABC
ABO
AB
ABC
40931101
40863401
00153229
44746001
40028701
001 18032, 42680901, Data Gap
Data Gap
41320101, 41330102, 41432701,
41432702, 41320103, 41432705,
41432703, 41432704, 41320104,
41320105, 41432706, 41432707,
Data Gap3
RESIDUE CHEMISTRY
860.1500
17I-4K
Crop Field Trials
Stuehemes
Celery
Spinach
Swiss Chard
AB
Data Gap
Data Gap
Data Gap
Data Gap
82
-------
NewGuj^Kne
Number
860.1520
Old Guideline
Nroiber
171-4L
Description
Processed Food
Figs
Watercress
Cottonseed Meal
Cottonseed Oil
Grapes- Juice
Grapes - Raisins
Pineapples - Juice
Pineapples - Jutce Concentrate
Plums/Prunes - I>ried
Sugar-Beet-Molasses
Tomatoes-Catsup
Tomatoes - Juice
Tomatoes - Paste
Tomatoes - Puree
UsePaaem- '
AB
Citations)
44726801
44237101
00032881
00032881
41410001
41410001
42179501
42179501
43274401
41336514
41336508
41336508
41336508
41336508
83
-------
84
-------
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket, located in Room
119, Crystal Mall #2,1921 Jefferson Davis Highway, Arlington, VA. It is open Monday through
Friday, excluding legal holidays, fiom 8:30 am to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of May 19,
2000. EPA then considered comments, revised the risk assessment, and added the formal "Response
to Comments" document and the revised risk assessment to the docket on January 31,2001.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site:
www.epa.gov/pesticide5/op
These documents include:
RED Documents:
1. HED's Development of Handler Risks for the Diazinon Risk Benefit Analysis. 1/15/02.
2. Revised HED Product and Residue Chemistry Chapter, 12/01/00
3. Occupational and Residential Exposure Assessment and Recommendations for the Reregistration
Eligibility Decision Document
4. Diazinon Refined Anticipated Residues/Acute and Chronic Dietary Risk Assessment (including
Beef Fat), 11/14/00
5. Exrx>sure Information by Crop Group
6. Revised Report of the Hazard Identification Assessment Review Committee, 11/30/00
7. Preliminary Health Effects Risk Assessments (Released 5/19/00)
, - Product and Residue Chemistry Chapter
- Occupational and Residential Exposure and Risk Assessment
- Refined Anticipated Residues/Acute and Chronic Dietary Risk Assessment
- Toxicology Chapter
- Replacement of Human Study Used in Risk Assessments
- Review of Diazinon Incident Reports
Quantitative Usage Analysis
85
-------
EFED Documents:
1. Final Revised Environmental Fate and Ecological Risk Assessment Chapter for the Reregistration
Eligibility Decision CHI Diazinon. 2-19-02.
2. Revised Science Chapter, 10/00
3. Revised Tier 2 EECs, 11/14/00
4. Environmental Fate and Effects Water Resource Assessment
BEAD Documents:
1. Benefits Assessment for Diazinon Use in Melons: Watermelon, Honeydew and Cantaloupe,
5/29/02
2. Biological and Economic Analysis of Diazinon on Carrots, 3/6/02
3. Biological and Economic Analysis of Diazinon on Lettuce, 3/13/02
4. Biological and Economic Analysis of Diazinon on Cabbage, 5/22/02
5. Biological and Economic Analysis of Diazinon on Pears, 3/13/02
6. Biological and Economic Analysis of Diazinon on Table Beets, 5/14/02
7. Benefits Assessment for Diazinon Use in Hops: Impact of Cancellation, 7/26/02
8. Cranberry Benefits Assessment for Diazinon Considering Risks for Mixer, Loader, and Applicator.
7/18/02
9. Plum/Prune Benefits Assessment for Diazinon. 5/15/02.
10. Apricot Benefits Assessment for Diazinon. 4/10/02
11. Biological and Economic Analysis of Diazinon on Sweet Cherries: Impacts of Cancellation. 6/14/02
12. Biological and Economic Analysis of Diazinon on Cole Crops, 4/8/02
13. Benefits Assessment for Diazinon Use in Peaches and Nectarines. 4/3/02.
14. Benefits Assessment for Diazinon Use inLowbush and Higfcbush Blueberries. 3/12/02.
15. Biological and Economic Analysis of Diazinon on Spinach: Impacts of Cancellation. 8-22-02
16. Benefits Assessment for Diazinon Use in Tomatoes: Impact of Cancellation. 6/7/02.
17. Biological and Economic Analysis of Diazinon on Processed Tomatoes. 6/3/02
18. Biological and Economic Analysis of Diazinon on Strawberries: Impacts of Cancellation. 7-2-02
19. Biological and Economic Analysis of Diazinon on Almonds: 7/24/02.
86
-------
Appendix D. Citations Considered to be Part of the Data Base Supporting the Interim
Registration Decision (Bibliography)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered
relevant by EPA in arriving at 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. Selection
from other sources, including 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)Q
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 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 EPA, by a description of the earliest
known submission. Bibliographic conventions used reflect the standard of the American National
Standards Institute (ANSI), expanded to provide for certain special needs.
a. Author.. Whenever the author could confidently be identified, the Agency has chosen to show a
personal author. When no individual was identified, the Agency has shown an identifiable
laboratory or testing facility as the author. When no author or laboratory could be identified,
the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the date is
followed by a question mark, the bibliographer has deduced the date from the evidence
87
-------
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, hi some cases, it has been necessary for me 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
know 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.
88
-------
BIBLIOGRAPHY
MRID CITATION
Balcomb, R., R. Stevens, and C. Bowen n. 1984. Toxicity of 16 granular insecticides
to wild-caught songbirds. BuUetin of Environmental Contamination and Toxicology,
33:302-307.
Grimes, J. and M. Jaber. 1987a. Diazinon MG8: A comparison of dietary LC50
values under choice and no-choice feeding conditions. Wildlife International Ltd.
Project No. 108-276.
Grimes, J. and M. Jaber. 1987c. Diazinon MG8: A comparison of dietary LC50
values with mallards of different ages. Wildlife International Ltd. Project No. 109-
278. (May 15)
Hill, E.F. and Mb. Camardese. 1981. Subacute toxicity testing with yound birds:
response in relation to age and intertest variability of LC50 estimates. Pp 41-65 in
D.W. Lamb and E.E. Kenaga (eds.), Avian and Mammalian Wildlife Toxicology:
Second Conference, ASTM STP 757. American Society for Testing and Materials,
Philadelphia, PA.
00109015 Fink, R. (1976) Final Report: Acute Oral LD50-Bobwhite Quail: Diazinon Technical]:
Project No. 108-120. (Unpublished study received Sep 15,1977 under 100-524;
prepared by Wildlife Inter-national Ltd., submitted by Ciba-Geigy Corp., Greensboro,
NC;CDL:231800-I)
00032881 Wene, G.P. (1965?) Diazinon Residues-Cottonseed (Seed, Hulls, Crude Oil, Refined
Oil, Screwpress Meal): AG-A 945. (Unpublished study received Mar 26,1965 under
100-460; prepared in cooperation with Univ. of Arizona, Cotton Research Center,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:000377-A)
00073372 U.S. National Institutes of Health (19??) Bioassay of Diazinon for Possible
Carcinogenicity. Bethesda, Md.: USNCI. (DHEW publication no. (NIH) 79-1392;
National Cancer Institute, Offcinogenesis Testing Program; published study,
CDL:238513-A)
00079017 Harris, SJB.; Holson, J.F.; File, K.R.; et al. (1981) A Teratology Study of Diazinon
(CAS Number 333-41-5) in New Zealand White Rabbits: CGA/SAI281005.
(Unpublished study, including submitter summary, received Aug 27,1981 under
100-524; prepared by Scientific Applications, Inc., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:245728-B)
89
-------
00104083 Stromberg, K. (1975) Sub-lethal Effects of Seed Treatment Pesticides on Breeding
Hen Pheasants. Doctoral Dissertation, Michigan State Univ., Dept of Fisheries and
Wildlife. (Unpublished study received Mar 5,1979 under 239-579; submitted by
Chevron Chemical Co., Richmond, CA; CDL:237966-A)
00104923 Woodard Research Corp. (1964) Diazinon Safety Evaluation on Fish and Wildlife.
(Unpublished study received Jul 23,1965 under unknown admin, no.; submitted by
Ciba-Geigy Corp., Greensboro, NC; CDL:165060-A)
00109022 Vilkas, A. (1976) Acute Toxicity of Diazinon Technical to the Water Flea, Daphnia
magna Straus: AES Proj. #7613-500. (Unpublished study received Sep 15,1977
under 100-524; prepared by Union Carbide Corp., submitted by Ciba-Geigy Corp.,
Greensboro, NC; CDL:231800-P)
00118032 Guth, J.; Imbo^ R. (1972) Adsorption and Leaching Behaviour of Diazinon in Various
Soils: SPR 46/72 S. (UrqnibHshed study received Nov 5,1982under 4581-351;
prepared by Ciba-Geigy, Ltd., Switz., submitted by Agchem Div., Pennwaft Corp.,
Philadelphia, PA; CDL248818-M)
00103959 Calmbacher, C. (1978) Acute Toxicity of San 3261 Lot No. 7801 to the Rainbow
Trout,... Richardson: UCES Project # 11506-16-02. (Unpublished study received
Mar 1,1979 under 11273-EX-15; prepared by Union Carbide Corp., submitted by
Sandoz, Inc., Crop Protection, San Diego, CA; CDL:097841-AC)
00103960 Calmbacher, C. (1978) Acute Toxicity of San 3261 Lot #7801 to Bluegill Sunfish,
Rafinesque: UCES Project # 11506-16-03. (Unpublished study received Mar 1,1979
under 11273-EX-15; prepared by Union Carbide Corp., submitted by Sandoz, Inc.,
Crop Protection, San Diego, CA; CDL:097841-AD)
00146179 Nissimov,S. (1984) Diazol Tech Acute Oral Toxicity in the Rat: Report No.
MAK/063/DZL/TECH. Unpublished study prepared by Life Science Research Israel
Ltd. 21 p.
00153017 Infuma, R. (1985) A Teratology Study of Diazinon Technical in Charles River Rats:
Report No. 52-83. Unpublished report prepared by Ciba-Geigy Corp. 264 p.
00153229 Martinson, J. (1985) Photolysis of Diazinon on Soil: Final Report: Biospherics Project
No. 85-E-044 SP. Unpublished study prepared by Biospherics Inc. 135 p.
40028701 Das, Y. (1986) Soil Metabolism of Diazinon under Aerobic (Sterile and Unsterile) and
Anaerobic (Unsterile) Conditions: Study No. 85 E044SM. Unpublished study
prepared by Biospherics Incorporated 77 p.
90
-------
40509801 Surprenant, D. (1987) Static Acute Toxicity of Diazinon Ag500 to Rainbow Trout
(Salmo gairdneri): Laboratory Study No. 87-12-2570. Unpublished study prepared
by Springbom Life Sciences, Inc. 50 p.
40509802 Surprenant, D. (1987) Static Acute Toxicity of Diazinon Ag500 to BhiegUl (Lepomis
macrochirus): Laboratory Study No. 87-12-2568. Unpublished study prepared by
Springbom Life Sciences, Inc. 52 p.
40509803 Surprenant, D. (1987) Static Acute Toxicity of Diazinon Ag500 to Daphnids (Daphnia
magna): Laboratory Study No. 87-12-2572. Unpublished study prepared by
Springbom Life Sciences, Inc. 48 p.
40509804 Canez, V. (1988) Nontarget Phytotoxicity Test Vegetative Vigor Tier 1: Diazinon
MG-8: Laboratory Study No. LR87-37A. Unpublished study prepared by
Pan-Agricultural Laboratories, Inc. 127 p.
40509805 Canez, V. (1988) Nontarget Phytotoxicity Test: Seed Germination/ Seedling
Emergence: Tier 1: Diazinon MG-8: Laboratory Study No. LR87-37B. Unpublished
study prepared by Pan-Agricultural Laboratories, Inc. 151 p.
40509806 Hughes, J. (1988) The Toxicity of Diazinon Technical to Selenastrum capricomutum:
Diazinon Technical: Laboratory Study No. 0267-40-1100-1. Unpublished study
prepared by Malcolm Pirnie, Inc. 122 p.
40509806 Hughes, J. (1988) The Toxicity of Diazinon Technical to Selenastrum capricomutum:
Diazinon Technical: Laboratory Study No. 0267-40-1100-1. Unpublished study
prepared by Malcolm Pimie, Inc. 122 p.
40625501 Surprenant, D. (1988) Diazinon Technical: Acute Toxicity of Diazinon Technical to
Mysid Shrimp (Mysidopsis bahia): Study No. 88-3-2676. Unpublished study
prepared by Springbom Life Sciences, Inc. 57 p.
40625502 Surprenant, D. (1988) Diazinon Technical: Acute Toxicity of Diazi- non Technical to
Eastern Oysters ( Crassostrea virginica): Study No. 88-3-2656. Unpublished study
prepared by Springbom Life Sciences, Inc. 56 p.
40660802 Dollenmeier, P. (1986) Gene Mutations Test L5178Y/TK+/-Mouse Lymphoma
Mutagenicity Test: Diazinon: Laboratory Study No. 840396. Unpublished study
prepared Ciba-Geigy Limited. 23 p.
91
-------
40660805 Ceresa, C. (1988) Structural Chromosomal Aberration Test Micronucleus Test,
Mouse: Diazinon: Laboratory Study No. 8716%. Unpublished study prepared by
Ciba-Geigy Limited. 32 p.
40660807 Tai, C. (1984) 21-day Dermal Toxicity Study in Rabbits: Diazmon Technical:
Laboratory Study No. 842007. Unpublished study prepared by Ciba-Geigy Corp.
215 p.
40803001 Canez, V. (1988) Diazinon Technical MG8: Nontarget Phytotaxicity Test Seed
GemrinanWSeedling Emergence: Tier 2: Project ID. LR88-18B. Unpublished study
prepared by Pan-Agricultural Laboratories, hie. 44 p.
40803002 Canez, V. (1988) Diazinon Technical MG8: Notarget Phytotoxicity Test Vegetative
Vigor Tier 2: Project ID. LR88-18A. Unpublished study prepared by
Pan-Agricultural Laboratories, Inc. 95 p.
40815004 Barnes, T. (1988) Diazmon (MG-8): 90-Day Oral Toxicity Study in Dogs: Project ID
882012. Unpublished study prepared by Ciba-Geigy Corp. 647 p.
40863401 Spare, W. (1988) Aqueous Photolysis of Carbon 14|-Diazinon by Natural Sunlight
Agrisearch Project No. 12100-A. Unpublished study prepared by Agrisearch Inc. 92
P-
40895301 Fletcher, D.; Pedersen, C. (1988) Diazinon MG8 Technical: 14-Day Acute Oral LD50
Study in Mallard Ducks: Project E>: BLAL No. 88 DD 56. Unpublished study
prepared by Bio-Life Associates, Ltd 35 p.
40895302 Fletcher, D.; Pedersen, C. (1988) Diazinon MG8 Technical: 8-Day Acute Dietary
LC50 Study in Mallard Ducklings: Project ID: BLAL No. 88 DC 105. Unpublished
study prepared by Bio-Life Associates, Ltd. 33 p.
40895303 Fletcher, D.; Pedersen, C. (1988) Diazmon MG8 Technical: 14-Day Acute Oral LD
50 Study in Brown-headed Cowbirds: Project ID: BLAL No. 88 SB 103.
Unpublished study prepared by Bio-Life Associates, Ltd. 41 p.
40895305 Fletcher, D.; Pedersen, C. (1988) Diazinon 14G: 14-Day Acute Oral LD50 Study in
Mallard Ducks: Project ID: BLAL No. DD 54. Unpublished study prepared by
Bio-Life Associates, Ltd. 33 p.
40895306 Fletcher, D.; Pedersen, C. (1988) Diazinon 14G: 14-Day Acute Oral LD50 Study in
Browr^headedOwbirds: Project ID: BLAL No. 88 SB 101. Unpublished study
prepared by Bio-Iafe Associates, Ltd. 37 p.
92
-------
40895307 Fletcher, D.; Pedersen, C. (1988) Diazinon AG500: 14-Day Acute Oral LD50 Study
in Mallard Ducks: Project No. BLAL No. 88 DD 55. Unpublished study prepared by
Bio-Life Associates, Ltd. 54 p.
40895308 Fletcher, D.; Pedersen, C. (1988) Diazinon AG500: 8-Day Acute Dietary LC50 Study
in Mallard Ducklings: Project ID: BLAL No. 88 DC 104. Unpublished study prepared
by Bio-Life Associates, Ltd. 33 p.
40895309 Fletcher, D.; Pedersen, C. (1988) Diazinon AG500: 14-Day Acute Oral LD50 Study
in Brown-headed Cowbirds: Project ID: BLAL No. 88 SB 102. Unpublished study
prepared by Bio-Life Associates, Ltd. 41 p.
40910904 Allison, D.; Hermanutz, D. (1977) Toxicity of Diazinon to Brook trout and Fathead
Minnows. U.S. EPA Environmental Research Laboratory-Duluth, Office of Research
and Development. EPA-600/3/77-060. 4 p.
40914801 Goodman, L.; Hansen, D.; Coppage, D.; et al. (1979) Diazinon: Chronic toxicity to,
and brain acetylcholinesterase inhibition in, the Sheepshead minnow, Cyprinodon
variegatus. Transactions of the American Fisheries Society 108:479-488.
40931101 Matt, F. (1988) Hydrolysis of Carbon 14|-Diazinon in Buffered Aqueous Solutions:
Final Report: Laboratory Project ID: HLA 6117-156. Unpublished study prepared by
Hazleton Laboratories America, Inc. 90 p.
41108901 Capps, T. (1989) Characterization and Identification of Diazinon Metabolites in Rats:
Project No. ABR-88164. Unpublished study prepared by Ciba-Geigy Corp. in
cooperation with Wil Research Laboratories, Inc. 198 p.
41119701 Campbell, W. (1989) Diazinon, Technical (GS 24480 Tech): Response to EPA
Requests on a Mouse Lymphoma Study Submitted to EPA 6/14/88. Unpublished
study prepared by Ciba-Geigy Corp. 12 p.
41137003 Kuhn, J. (1989) Acute Oral Toxicity Study in Rats: D.ZJL Lawn and Garden Insect
Control: Study No. 6066-89. Unpublished study prepared by Stillmeadow, Inc. 29 p.
41158101 Gfcnis, M. (1989) Diazinon Technical: A Two Generation Reproductive Study in
Albino Rats: Project ID MIN 852218. Unpublished study prepared by Ciba-Geigy
Corp. 1469 p.
41320101 Jacobson, B.; Gresham, M. (1989) Terrestrial Field Dissipation for Diazinon 14G Crop
Application - California: Lab Project Number 36804. Unpublished study prepared by
Analytical Biochemistry Laboratories, Inc. 168 p.
93
-------
41320103 Guy, S. (1989) Field Dissipation Study on Diazinon 50WP for Terrestrial Uses on
Citrus in Florida: Lab Project Number A010/003:1641/88/71/14/01A/07.
Unpublished study prepared by Huntingdon Analytical Services. 337 p.
41320104 Kimmel, E.; Ruzo, L.; Johnson, T. (1989) Field Dissipation of Diazinon AG500
Applied to Bareground: Lab Project Number 239:1199. Unpublished study prepared
by Pharmacology and Toxicology Research Laboratory - East in Association with
Pharmacology and Toxicology Research Laboratory - West 121 p.
41320105 Kimmel, E.; Ruzo, L.; Johnson, T. (1989) Field Dissipation of Diazinon AG500
Applied to Citrus (Oranges): Lab Project Numben240:Report No. 1204.
Unpublished study prepared by Pharmacology and Toxicology Research Laboratory -
East in Association with Pharmacology and Toxicology Research Laboratory - West
121 p.
41322902 Marselas, G. (1989) Diazinon: A One-Generation Reproduction Study with the
Northern Bobwhite (Colinus Virgmianus): Lab Project Number 108/292.
Unpublished study prepared by Wildlife International Ltd. 145 p.
41332609 Kuhn, J. (1989) Diazinon AG500 FL 890346: Acute Oral ToxicityStudy in Rats: Lab
Project Number 5966789. Unpublished study prepared by Stillmeadow, Inc. 24 p.
41332616 Kuhn, J. (1989) Diazinon 4E FL 891641: Acute Oral Toxicity Study in Rats: Lab
Project Number 6306789. Unpublished study prepared by Stillmeadow, Inc. 33 p.
41336508 Ross, J. (1989) DiazinonFruiting Vegetable Crop Grouping: Residue Summary:
Project Nos. ABR-89080; 302195; MW-IR-302-88, etc. Unpublished study
prepared by Ciba-Geigy Corp., Residue Dept in cooperation with EPL Bio-Analytical
Services, Inc. 202 p.
41336514 Ross, J. (1989) Diazinon-Root and Tuber Vegetable Crop Grouping: Residue
Summary: Project Nos. ABR-89085; 302191; 88-0083. Unpublished study prepared
by Ciba-Geigy Corp., Residue Dept in cooperation with En-Cas Analytical
Laboratories. 279 p.
41407202 Kuhn, J. (1990) Acute Oral Toxicity Study in Rats: Diazinon 14G FL 892513: Lab
Project Number 6654-89. Unpublished study prepared by Stillmeadow, Inc. 12 p.
41407210 Kuhn, J. (1989) Acute Oral Toxicity Study in Rats: Diazinone SOW FL 892514: Lab
Project Number: 6656-89. Unpublished study prepared by Stillmeadow, Inc. 24 p.
94
-------
41407218 Kuhn, J. (1989) Acute Oral Toxicity Study in Rats: Diazinone MG8 FL 880045: Lab
Project Number 5942-89. Unpublished study prepared by Stillmeadow, Inc. 24 p.
414072 19 Kuhn, J. (1989) Acute Oral Toxicity Study in Rats: Diazinone MG8 FL 880045: Lab
Project Number 5942-89. Unpublished study prepared by Stillmeadow, Inc. 24 p.
41407220 Kuhn, J. (1989) Acute Inhalation Toxicity Study in Rats: Diazinone MG8 FL 880045:
Lab Project Number: 5947-89. Unpublished study prepared by Stillmeadow, Inc. 13
P-
41407221 Kuhn, 3. (1989) Primary Eye fcrhaian Study in Rabbits: Diazmone MG8 FL 880045:
Lab Project Number 5944-89. Unpublished study prepared by Stillmeadow, Me. 18
P-
41407222 Kuhn, J. (1989) Primary Dermal Irritation Study in Rabbits: Diazmone MG8 FL
880045: Lab Project Number: 5945-89. Unpublished study prepared by Stilhneadow,
Inc. 13 p.
41407223 Kuhn, J. (1989) Dermal Sensitization Study in Guinea Pigs: Diazinone MG8 FL
880045: Lab Project Number 5946-89. Unpublished study prepared by Stillmeadow,
Inc. 18 p.
41410001 Gold, B. (1990) Diazinon-Grapes: Residue Summary: Lab Project Number
ABR-90012. Unpublished study prepared by Ciba-Geigy Corp. 7 p.
41432701 Rice. F-J Jacobson, B.; Gresham, M (1990) Terrestrial Field Dissipation for Diazinon
14G Crop Application: Final Report: Lab Project Number 36806. Unpublished study
prepared by Analytical Bio-Chemistry Laboratories, Inc. 231 p.
41432702 Rice, F.; Jacobson, B.; Gresham, M. (1990) Terrestrial Field Dissipation for Diazinon
14G Bareground Application: Lab Project No:36805. Unpublished study prepared by
Analytical Bio-Chemistry Laboratories, Inc. 251 p.
41432703 Guy, S. (1990) Field Dissipation Study on Diazinon 50WP for Terrestrial Uses on
Apple in California: Lab Project No: A010. 005; 1641-88-71-14-02B-05.
Unpublished study prepared by Huntingdon Analytical Services. 403 p.
41432704 Walker, K. (1990) LX171-14 (Diazinon SOW): Field Dissipation Terrestrial on
Bareground in California: Lab Project Numbenl641-88-71-14-21E-06: R328809:
AGIO. 004. Unpublished studty prepared by Huntingdon Analytical Services, Inc. 337
P-
41432705 Guy, S. (1990) Field Dissipation Study on Diazinon 50WP for Terrestrial Uses on
Bareground in. Florida: Lab Project No: A010.02; 1641-88-71- 14-21E-08.
Unpublished study prepared by Huntingdon Analytical Services. 336 p.
95
-------
41432706 Bind, R. (1990) Diazinon AG500: Terrestrial Field Dissipation Bare Soil-New York:
Lab Project Number 264:1221:88158. Unpublished study prepared by
Pharmacology and Toxicology Research Laboratory-East in cooperation with
Agricultural Chemical Development Services, Inc., and others. 200 p.
41432707 Bird, R. (1990) Diazinon AG5000-Terrestrial Field Dissipau'on-Apples-New York:
Lab Project Number 263:1228: 88157. Unpublished study prepared by
Pharmacology and Toxicology Research Laboratory-East. 230 p.
41511001 Frey, L. (1990) An Evaluation of its Efifects on Wildlife Associated with Com Fields in
Eastern Maryland: Diazinon 14G: Lab Project Number. 108-297. Unpublished study
prepared by Wildlife International Ltd. 410 p.
41514701 Johnson, G. (1990) Diazinon 4G: An Evaluation of Ifs Effects OB Wildlife Associated
with Com Fields in Southern Iowa: Lab Project Number 108-298. Unpublished study
prepared by Wildlife International Ltd 440 p.
41535201 Fletcher, D. (1990) Diazinon 14G: A Field Monitoring Study of fee Efifects on Wildlife
of Pre-plant Soil Incorporated Applications of D-Z-N Diazinon 14G in Wiscousin
Carrots: Lab Project Number. LAL 89 FV 5. Unpublished study prepared by Bio-Life
Associates, Ltd. 595 p.
41557404 Geleick, D. (1990) Gene Mutations Test Salmonella and Escherichia/Liver-microsorne
Test Diazinon Technical (G-24480): Lab Study Number 891346. Ut^ublished study
prepared by Ciba-Geigy Ltd. 42 p.
41557405 Hertner, T. (1990) Diazinon Technical (G-24480): Test for other Genotoxic Effects:
Autoradiographic DNA Repair Test on Rat Hepatocytes: Lab Project Number
891345. Unpublished study prepared by Ciba-Geigy Ltd. 96 p.
41577301 Murli, H. (1990) Mutagenicity Test on Diazmon MG8 in an in vitro Cytogenetic Assay
Measuring Sister Chromatid Exchange Frequencies in Cultured Whole Blood Human
Lymphocytes: Lab Project No. 12226-0-448: TX-90-0093. Unpublished study
prepared by Hazleton Laboratories America, Inc. 22 p.
41577401 Kendall, R. (1990) The Response of Wildlife Exposed to Multiple Applications of
Diazinon SOW in Apple Orchards of Eastern Washington and South Central
Pennsylvania. Unpublished study prepared by The Institute of Wildlife and
Environmental Toxicology. 574 p.
96
-------
41580201 Fletcher, D. (1990) A Field Monitoring Study of the Effects on Wild life of Pieplant
Soil Incorporated Applications of D.Z.N. Diazinon 14 G in Texas Canots: Lab Project
Number: 89 FV 5. Unpublished study prepared by Bio-Life Associates, Ltd. 571 p.
41603201 Ceresa, C. (1989) Diazinon Technical (G-24480): Structural Oiromosomal Aberration
Test Supplement to Micronucleus Test, Mouse: Lab Project Number 8716%.
Unpublished study prepared by CibaGeigy Ltd. 8 p.
41687701 Murli, H. (1990) Mutagenicity Test on Diazinon MG8 in vivo Sister Chromatid
Exchange Assay: Lab Project Number: 12226/0/458. Unpublished study prepared by
Hazleton Laboratories America, Inc. 23 p.
41942001 Rudzki, M.; McCormick, G.; Arthur, A. (1991) Diazinon (MG-8): 52- Week Oral
Toxicity Study in Dogs: Lab Project Number 882014. Unpublished study prepared by
Ciga-Geigy. 621 p.
41942002 Kirchner, F.; McCormick, G.; Arthur, A. (1991) Diazinon (MG-8): One/Two Year
Oral Toxicity Study in Rats: Lab Project Number 882018. Unpublished study
prepared by Ciba-Geigy. 3101 p.
42179501 Wong, L. (1990) Diazinon-Pineapple Residue Study: Lab Project Number HSPA ES
89-5287. Unpublished study prepared by Hawaiian Sugar Planters Association. 136
P-
42680901 Shepler, K. (1993) Aged Leaching of delta-2-(carbon 14)Diazinan in Four Soil Types:
Lab Project Number 346W:131-91. Unpublished study prepared by PTRL-West,
Inc. 126 p.
43060601 Murli, H. (1993) Mutagenicity Test on In vivo Sister Chromatid Exchange Assay in
Female Mice: Diazinon MG87%: Lab Project Number: 15802-0-458: TX-93-0220.
Unpublished study prepared by Hazleton Washington, Inc. 40 p.
43132201 Leahy, C. (1993) Acute Rangefi^dingNeurotoxicity Study wiADZ.N Diazinon
MG87% in Rats: Final Report: Lab Project Number F-00174. Unpublished study
prepared by Ciba-Geigy Corp. 117 p.
43132203 Potrepka, R. (1994) Acute Cholinesterase Inhibition Time Course Study with D.Z.N
Diazinon MG87% in Rats: Final Report: Lab Project Number F-00185. Unpublished
study prepared by Ciba-Geigy Corp. 112 p.
97
-------
43132204 Chow, E,; Richter, A. (1994) Acute Neurotoxicity Study with D.Z.N Diazinon
MG87% in Rats: Final Report Lab Project Number F-00175. Unpublished study
prepared by Ciba-Geigy Corp. 543 p.
43274401 Ross, J. (1994) Amendment to DiazinonMagnitude of Residues in or on Stone Fruit
and Fractions Following Postemergence Foliar Applications of D.Z.R Diazinon 50W
or D.Z.N. Diazinon AG500: (MRID No. 42680301): Amendment 1: Lab Project
Number ABR-92020:302237:41-91. Unpublished study prepared by Ciba-Geigy
Corp. 259 p.
43543901 Chang, J. (1994) DZN Diazinon MG87(percent): Cholinesterase Inhibition in 28 Day
Study in Rats: Final Report Lab Project Number: F/00186. Unpublished study
prepared by Ciba Geigy Environmental Health Center. 125 p.
43543901 Chang, J. (1994) DZN Diazinon MG87(percent): Cholinesterase Inhibition in 28 Day
Study in Rats: Final Report Lab Project Number. F/00186. Unpublished study
prepared by Ciba Geigy Environmental Health Center. 125 p.
44132701 Classen, W. (1996) Delayed Neurotoxicity in Hens Following Acute Exposure: G
24480 Technical (Diazinon): Final Report Lab Project Number 952030. Unpublished
study prepared by Ciba-Geigy Ltd. 78 p.
44219301 Glaza, S. (1993) Acute Oral Toxicity Study of D-Z-N Diazinon MG87% in Rats: Final
Report Lab Project Number HWI6117-221. Unpublished study prepared by
Hazleton Wisconsin, Inc. 59 p.
44237101 Dorschner, K. (1997) Diazinon: Magnitude of the Residue on Watercress and in Water
Used for Watercress Production: Lab Project Number 3892: 3892.93-HI03:
3892.93-HIR03. Unpublished study prepared by University of Hawaii. 313 p.
44244801 Sousa, J. (1997) Diazinon-Chronic Toxicity to Mysids, (Mysidopsis bahia), Under
Flow-Through Conditions: (Final Report): Lab Project Number 97-2-6882:
1781.1196.6544.530:405-96. Unpublished study prepared by Springbom Labs, Inc.
102 p.
44244802 Sousa, J. (1997) Diazinon-Chronic Toxicity to Sheepshead Minnow, (Cyprinodon
variegatus), Under Flow-Through Conditions: (Final Report): Lab Project Number:
97-2-6887:404-96: 1781.1196.6545.520. Unpublished study prepared by
Springbom Labs, Inc. 88 p.
98
-------
44348801 Lunchick, C. (1997) Assessment of Applicator Exposure and Residential
Postapplication Exposure Resulting from the Indoor Residential Uses of Diazinon: Lab
Project Number 154-97: ABR-97031. Unpublished study prepared by Jellinek,
Schwartz & Connolly, Inc. 47 p.
44726801 Dorschner, K. (1998) Diazinon: Magnitude of the Residue on FigiLab Project Number
B4101: B4101.96-CA58: B4101.96CA-59. Unpublished study prepared by
University of California, 357 p.
44746001 Spare, W. (1990) Soil Metabolism of (carbon 14)-Diazinon: Lab Project Number
12108: N-0964-0900. Unpublished study prepared by Agrisearch Incorporated. 124
P-
4495 9101 Rosenheck, L. (1999) Determination of Transferable Residues on Turf Treated with
Diazinon: Final Report: Lab Project Number: 210-98: 980018: 302925. Unpublished
study prepared by Central California Research Laboratories. 477 p. {OPPTS
875.2100}
44972201 Klonne, D. (1999) Integrated Report for Evaluation of Potential Exposures to
Homeowners and Professional Lawn Care Operators Mixing, Loading, and Applying
Granular and Liquid Pesticides to Residential Lawns: Lab Project Number OMAOO5:
OMAOO1: OMAOO2. Unpubhshed study prepared by Ricerca, Inc., and Morse
Laboratories. 2213 p.
45184305 Rosenheck, L. (2000) Determination of Exposure During the Mixing, Loading and
Application of Liquid Diazinon to Residential Turf Through the Use of Passive
Dosimetry and Biological Monitoring: Lab Project Number. 767-98:
I024480NAU950T. Unpublished study prepared by Development Resources/
Chemical Support Department, Novartis Crop Protection, Inc. 574 p.
45184305 Rosenheck, L. (2000) Determination of Exposure During the Mixing, Loading and
Application of Liquid Diazinon to Residential Turf Through the Use of Passive
Dosimetry and Biological Monitoring: Lab Project Number 767-98:
I024480NAU950T. Unpubhshed study prepared by Development Resources/
Chemical Support Department, Novartis Crop Protection, Inc. 574 p.
99
-------
001
-------
Appendix £. Generic Data Call-in
See attached table for a list of generic data requirements. Note that a complete Data Call-in
(DCI), with all pertinent instructions, is being sent to registrants under separate cover.
101
-------
102
-------
United States Environmental Protection
Agency Washington, D.C. 20460
DATA CALL-IN RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case*and Name
0238 Diazinon
Chemical # and Name 057801
Diazinon
3. Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID # GDCI-057801 -NNNNN
4. EPA
Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because 1
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product fs an EUP and
f agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
NNNNNN-NNNNN
N.A.
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete.
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
acknowledge that any
9. Date
10. Name of Company
11. Phone Number
-------
DRAFT COPY
Page 1 of 2
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print In ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case * and Name
0238 Diazinon
Chemical # and Name
Diazinon
057801
3. Date and Type of DCt and Number
DD-MMM-YYYY
GENERIC
ID# GDCI-057801-NNNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
875.1100
875-1300
875.1500
835.1230
835.1410
835.6100
830.6313
830.7050
Dermal exposure-outdoor
nhalatlon exposure-outdoor
Biological monitoring
Ironmental Fata Data Requirements (Convamional
Envr
IFem
Sediment and soil absorptlon/desonptlon for parent
and degradates
(1)
(2,3)
Product Chemlstw Data Requirements (Conventional
Chemical} '
Stability to sunlight, normal and elevated
temperatures, metals, and metal Ions
(4)
Residue Chemistry Data Requirements for Food Uses
(Conventional ChemlcaTi
A, B, C, H, 1, K, L, M, O
A, B, C, H,.1; K; 4, Mf O
A, B, C, H, I, K, L, M, 0
A, B, C, H, I, K, L, M, O
A^C.HJ.K^MiQ
A, B.C. H.I. K, L, M, 0
A, B, C, H, I, K, L, M, O
A.B^C.H.I.K.l.M.O
TGAI
12
12
12
12
12
24
B
B
10. Certification I certify that the statements made on this form and ail attachments are true, accurate, and comp ete. I acknowledge that any | n. Date
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
12. Name of Companv
-------
United States Environmental Protection " ^^"^^^^^^^^^^^^JWfflpPIRWWW^"
Agency Washington, D.C. 20460 OMB Approval 2070-0057
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE |
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on mis form.
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
860.1500
860.1500
860.1500
860.1500
850.1400
S50.1500
850.2100
859.2200
850.2300
870.3250
5. Study Title
Crop field trials(BLUEBERRY)
Crop field trials(CELERY)
Crop flew Wal9(8PJNAQH}
Crop field trialsfSWISS CHARD)
ferrestrial and Aauatlc Nontarqet 91
2- Case* and Name 3. Date and Type of DCI and Number
0238 Diazinon DD-MMM-YYYY
Chemical # and Name 057801 GENERIC
Diazinon ID# GDCI-057801-NNNNN
(6)
(7)
(8)
nanisms Data
requirements (Conventional Chemical) i ,
Fish early-life stage toxicity test
Rsft life cyete toxicity
Avian acute oral toxicity test (9,10)
Avian dietary toxfcRy test (11 ,12)
Avian reproduction test
Foxlcolocw Data Requirements (Conventional Chemlcall
90-day dermal toxicity
(13,14)
P
R
0
T
0
C
0
L
Progress
Reports
1
,' .
2
-'
3
6. Use
Pattern
A,8.C,H,I,K1LIM,0|
A, B, C, H, I, K, L. M, 0
A, 8, C, H, t, K, L, M, 0
A, B, C, H, I, K, L, M, O
A, B, C, H, 1, K, L, M, O
A, B, C, H, lt K, L, M, O
A, B, C, H, 1, K, L, M, 0
A, B, C, H, 1, K, L, M, O
A, B, C, H, 1, K, L, M, O
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
TCP
TEP
PEP
TEP
TGAI. TEP
TGAt .
DEGR
FGA1
8. Time
Frame
(Months)
24
24
24
24
12
12
12
12
24
24
9. Registrant
Response
Date
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0238 Diazinon
DCI Number: GDCI-057801-NNNNN
Key: DEGR = Degradant [DEGR]; TEP = Typical End Use Product [TEPJ; TGAl Technical Grade Active Ingredient 1TGAI]; TGAI, TEP = Technical Grade of the Active Integredient or Technical End-Use
Product
Use Categories Key:
A - Terrestrial food crop H -
B - Terrestrial feed crop I -
C - Terrestrial nonfood crop K -
Greenhouse food crop L -
Greenhouse nonfood crop M -
Residential O -
Indoor food use
Indoor nonfood use
Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Requirement based on use patterns and other pertinent factors Including, but not limited to, Henry's Law Constant. In view of methodological difficulties with the study of photodegradation in
air, prior consultation with the Agency regarding the protocol Is recommended before the test Is performed.
1
2 Required for aquatic food and nonfood crop uses for aquatic sites that are Intermittently dry. Such sites include, but are not limited to cranberry bogs and rice paddies.
3 Environmental chemistry methods used to generate data associated with this study must Include results of a successful confirmatory method trial by an independent laboratory. The
environmental chemistry methods must Include a statement of no data confidentiality claims, I.e., non-CBI. Test standards and procedures for Independent laboratory validation are available
as addenda to the guideline for this test requirement.
4 Data on the stability to metals and metal ions Is required only if the active Ingredient is expected to come in contact with either material during storage.
5 Six trials total required In Region 1 (1 trial), Region 2 (2 trials), Region 5 (2 trials), and Region 12 (1 trial). The emulsifiable concentrate and wettable powder formulations must be tested in all
locations, and slde-by-slde tests are recommended.
6 Five trials total required In Region 3 (1 trial) and Region 10 (4 trials)
7 One trial each required in Regions 1,2,6,9, and 10, reflecting pre-plant application of the emulsifiable concentrate formulation. Five foliar applications of the emulsifiable concentrate or
wettable powder formulation required at 0.5 Ib al/A with a 10-day PHI In Regions 1, 2,6,9, and 10.
8 Three trials required reflecting pre-plant applications with the emulsifiable concentrate and foliar applications with the wettable powder and emulsifiable concentrate formulations,
g Data using the TGAI are required to support all outdoor end-use product uses Including turf. Data are generally not required to support end use products In the form of a gas, a highly volatile
liquid, a highly reactive solid, or a highly corrosive material.
10 Data are preferred on redwing blackbird (Agelalus phoneiceus) and either mallard or bobwhite quail.
11 Data using the TEP are conditionally required baaed on the results of the avlan acute oral (TGAI) and avian subacute dietary tests, intended use pattern, and pertinent environmental fate
characteristics that Indicate potential exposure.
12 Data are preferred on mallard and bobwhite quail.
13 EP testing Is required if the product, or any component of it, may increase dermal absorption of the active Ingredient(s) as determined by testing using the TGAI, or increase toxic or
pharmacotoglc effects.
14 Required for food uses if either of the following criteria is met: (I) the use pattern is such that the dermal route would be the primary route of exposure; or (ii) the active ingredient is known or
expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite Is the toxic moiety.
-------
Appendix F. Product Specific Data Call-in
See attached table for a list of product-specific data requirements. Note that a complete Data
Call-In (DCI), with all pertinent instructions, is being sent to registrants under separate cover.
107
-------
108
-------
United States Environmental Protection
Agency Washington, D.C. 20460
DATA CALL-IN RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0238 Diazinon
Chemical # and Name 057801
Diazinon
3. Date and Type of DC) and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDC1-057801-NNNN
4. EPA
Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as Indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
1 agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
NNNNNN-NNNNN
N.A.
N.A.
8. Certification I certify that he statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable taw.
Signature and Title of Company's Authorized Representative
9. Date
10. Name of Company
11. Phone Number
-------
DRAFT COPY
Page 1 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print In Ink. Please read carefully the attached instructions and supply the Information requested on this form.
Use additional sheet(s) if necessary,
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case* and Name
0238 Diazinon
r,»*o *, mimm.mm
EPA Reg. No. NNNNNN-NNNNN
Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
PDCI-057801-NNNN
4, Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
830.1550
830.1600
830.1620
830.1650
830,1670
830,1700
830.1750
830,1800
830.6302
830.8303
830.6304
Product Identity and composition (1)
Description of materials usod to produce the product (2)
A, C, D, E, F. G, H, ,J,
K, L, M, N, 0
A,C,D,:E,F,G,Hl ,J,
Description of production process
Description of formulation process
Discussion of formation of impurities
Preliminary analysis .
Certified limits
Enforcement analytical method
Color
Physical state
Odor
(3)
{4}
(5)
(Q ,7 ,8)
(9.10)
(11)
(12)
(13)
(14)
A, C, D,
K, L, M,
A.C.D,
K,I_M,
A, C, D,
K. L, M,
A, C. D,
K.L,M,
A, C, D,
K, L, M,
A.C.D,
K, L; M,
A, C, D,
K, L, M,
A,C,Dt
K, L, M,
A, C, D,
K, L, M,
E.F.G.H.I.J,
N,0
E, F, G, H, I, J,
N.O
E, F, G, H, I, J,
N.O
E.'F.Q.-H.U.
N, 0
E.F.G.H.I.J,
N.O
E.F,Q,H,U,
N,0
E.F.G, H.I.J,
N.O :
E,F,G,H,U,
N,0
E, F,G,H,I,J,
N,0
MP or EP
MPorEP
MP or EP
MPorEP
MP or EP
MP or EP
MP or EP
MPorEP
MPorEP
MPorEP
MP or EP
. Certification 1 certify that the statements made on this form and all attachments are true, accurate, and compete. 1 acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
11. Date
-------
Agency Washington, D.C. 20460 1 OMB Approval 2070-0057
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830,6313
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830,7000
830.7050
830-7100
830.7300
5. Study Title
2. Case # and Name 3. Date and Type of DCI and Number
0238 Diazinon DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-057801-NNNN
EPA Reg. No. NNNNNN-NNNNN
Stability to sunlight, normal and elevated (15 ,16)
temperatures, metals, and metal ions
Oxidizing or reducing action
Flammablttty
Explodability
Storage stability of product
Miscibiiity
Corrosion characteristics
Dielectric breakdown voltage
pH of water solutions or suspensions
UV/Visible absorption
Viscosity
Density/relative density
(17)
(18)
(19)
(20)
(21)
(22)
(23)
, I (24,25)
(26)
(27 ,28)
H
R
0
T
0
C
0
Progress
Reports
1
2
3
-
6. Use
Pattern
A, C, D, E, F( G, H, , J,
K,t,M,N,0
A, C, D, E, F, G, H, ,J,
K, L, M, N, O
A,C,D,E,F,G,H,l,Jr
K, 1, M, N, 0
A, C, D, E, F, G, H, , J,
K, L, M, N, O
K't'S'l'S0'^^
A, C, D, E, F, G, H. ,J,
K. L, M, N, 0
A, C, Df E, F, G, H, 1, J,
A. C. D, E, F, G, H, ,J,
K, L, M, N, O
A, C, D, E, F, G, H, ,J,
K, L, M, N, O
KXftWo
A, C, D, E, F, G, H, , J,
K, L, M, N, O
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
TGAi
MP or EP
MP or EP
MP or EP
MPorEP
MP or EP
MPor&P
MP or EP
MPorEP
MP or EP
MPorEP
MP or EP
8. Time
Frame
(Months)
B
B
3
B
B
B
B
B
3
3
B
B
9. Registrant
Response
Date
-------
DRAFT COPY
Page 3 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANTS RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) If necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0238 Diazinon DD-MMM-YYYY
NO STREET ADDRESS PRODUCT SPECIFIC
NO CITY, XX 00000 ID# PDCI-057801-NNNN
EPA Reg. No. NNNNNN-NNNNN
4. Guideline
Requirement
Number
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
5. Study Title
Toxlcoloov Data Requirement* (Conventional ChtmlcaU
Acute Oral Toxiclty (29)
Acute dermal toxteity (30,31)
Acute inhalation toxiclty (32)
Aisute eye Irritation (33)
Acute dermal irritation (34 ,35)
SKIn sensltizatlon (36 ,37)
M
R
0
T
0
C
o
Progress
Reports
1
2
3
6. Use
Pattern
A. C, D. E, F, Q. H. ,J,
K, L, M, N, 0
A,G;Q,EIF»G1H,I,^
K,l;M,N,0
A, C, D, E, F, G, H, , J,
K, L, M, N, O
A,G,D,E.FJG,H, .J,
K.UM.N.O
A.C.D.E.F, G, H, ,J,
K, L, M, N, 0
A1C,D,E,F;.G,H, ,J,
K,L,M,N,0
7. Test
Substance
MP or EP
MBofEP
MP or EP
MPorEP
MP or EP
MP or EP
8. Time
Frame
(Months)
8
3
3
9
B
3
9. Registrant
Response
Initial to indicate certification as to Information on this page 1 Date
(full text of certification is on page one). ^ ^^^^_ ^^^^^ ^ ^^^^^^^^^^^^^^^i^Bi^i^i^i^Mi^i^iM
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^l
-------
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0238 Diazinon
DCI Number: PDCI-057801 -NNNN
Key: MP or EP = Manufacturing-Use Product or End-Use Product; TGAI - Technical Grade Active Ingredient fTGAI]
Use Categories Key:
A - Terrestrial food crop E -
C - Terrestrial nonfood crop F -
D - Aquatic food crop G -
Aquatic nonfood outdoor use H - Greenhouse food crop
Aquatic nonfood industrial use I - Greenhouse nonfood crop
Aquatic non-food residential J - Forestry use
K - Residential
L - Indoor food use
M - Indoor nonfood use
N - Indoor medical use
O - Residential Indoor use
Footnotes: [The following notes are referenced In column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Data must be provided in accordance with the "Product Composition" Section.(158.155)
2 Data must be provided in accordance with the "Description of Materials used to Produce the Product" Section.(158.160)
3 Data must be provided in accordance with the "Description of Production Process" Section.(158.162)
4 Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
5 Data must be provided In accordance with the "Description of Formation of Impurities" Section(158.167)
6 Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
7 Required for TGAIs and products produced by an integrated system.
8 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated Into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
g Data must be provided in accordance with the "Certified Limits" Section(158.175)
10 If the TGAI cannot be Isolated, data are required on the practical equivalent of the TGAI (I.e., if the active ingredient Is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
11 Data must be provided in accordance with the "Enforcement Analytical Method" Section.(158.180)
12 If the TGAI cannot be Isolated, data are required on the practical equivalent of the TGAI (i.e., If the active ingredient is either an acid, base or tonic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
13 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI {i.e., if the active ingredient Is either an acid, base or ionic form, and it is formulated Into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
14 If the TGAI cannot be Isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient ts either an acid, base or ionic form, and it Is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
15 If the TGAI cannot be Isolated, data are required on the practical equivalent of the TGAI (i.e., if the active Ingredient Is either an add, base or ionic form, and it Is formulated into salts or esters,
the concentration of the active ingredient In these products must be expressed in acid equivalent or active equivalent).
-------
DRAFT COPY
Page 2 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0238 Diazinon
DCI Number: PDCI-057801-NNNN
Key: MP or EP = Manufacturing-Use Product or End-Use Product; TOAI - Technical Grade Active Ingredient [TGAI]
Use Categories Key:
A - Terrestrial food crop
C - Terrestrial nonfood crop
D - Aquatic food crop
E - Aquatic nonfood outdoor use H -
F - Aquatic nonfood Industrial use I -
G - Aquatic non-food residential J -
Greenhouse food crop
Greenhouse nonfood crop
Forestry use
K - Residential
L - Indoor food use
M - Indoor nonfood use
N - Indoor medical use
O - Residential Indoor use
Footnotes: fThe following notes are referenced in column two (S. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
16 Data on the stability to metals and metal Ions Is required only if the active ingredient Is expected to come in contact with either material during storage.
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Required If the product contains an oxidizing or reducing agent
Required when the product contains combustible liquids.
Required when the product is potentially explosive.
Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 630.6317} and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Date Call-Ins Issued under the Registration Eligibility Decision (RED)/lnterlm Registration Eligibility Decision (IRED) Documents."
Required if the product Is an emulslflable liquid and is to be diluted with petroleum solvents.
Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Registration Eligibility Decision (IRED) Documents."
Required If the end-use product Is a liquid and Is to be used around electrical equipment.
If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (I.e., if the active ingredient is either an acid, base or ionic form, and It is formulated Into salts or esters,
the concentration of the active ingredient In these products must be expressed In add equivalent or active equivalent).
Required If the product Is dlsperslble with water.
Required if the product is a liquid.
If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active Ingredient Is either an acid, base or ionic form, and it is formulated Into salts or esters,
the concentration of the active Ingredient In these products must be expressed In acid equivalent or active equivalent).
True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
Not required if test material is a gas or a highly volatile liquid.
Not required if test material Is a gas or a highly volatile liquid.
-------
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0238 Diazinon
DCI Number: PDCI-057801-NNNN
Key: MP or EP = Manufacturing-Use Product or End-Use Product; TOAi» Technical Grade Active Ingredient [TGAIj
Use Categories Key:
A - Terrestrial food crop E -
C - Terrestrial nonfood crop F -
D - Aquatic food crop G -
Aquatic nonfood outdoor use H -
Aquatic nonfood industrial use I -
Aquatic non-food residential J -
Greenhouse food crop
Greenhouse nonfood crop
Forestry use
K Residential
L - Indoor food use
M - Indoor nonfood use
N - Indoor medical use
O - Residential Indoor use
Footnotes: FJne following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
31 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
32 Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).
33 Not required If test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
34 Not required if test material is a gas or a highly volatile liquid.
35 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
36 Not required if test material Is corrosive to skin or has a pH of less than 2 or greater than 11.5.
37 Required if repeated dermal exposure is likely to occur under conditions of use.
-------
116
-------
Appendix G. EPA's Batching of Diazinon 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 reregistratkm of products containing diazinon as the active ingredient, the Agency
has batched products which can be considered similar for purposes of acute toxicity. Factors
considered in the sorting process include each product's active and inert ingredients (identity, percent
composition and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol,
wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary
labeling, etc.). Note that the Agency is not describing batched products as "substantially similar" since
some products within a batch may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require,
at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a single
battery of six acute lexicological 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 lexicological
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 todays 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 UK 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,"
fists 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: Developing Data (Option 1), Submitting an Existing
Study (Qption 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a
117
-------
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.
One hundred and fifty five products were found which contain diazinon as the active ingredient
These products have been placed into four batches and a "no batch" category in accordance with the
active and inert ingredients and type of formulation. Furthermore, the
following bridging strategies are deemed acceptable for this chemical.
Batch 11: The representative eye studies for this batch should be conducted on EPA Reg; 572-
292,9198-62, or 32802-5.
* Batch 12: The representative acute toxicity studies (except primary eye study) should be conducted
on tbeproctas with the highest percentage of active ingredient A primary eye irritation study
should be conducted on each product listed in this batch.
Batch 14: EPA Reg. Nos. 3546-27 & 19713-317 may cite data conducted on EPA Reg. No.
6218-69 or 10088-71.
No Batch: Each product in this Batch should generate their own data.
NOTE: The technical acute toxicity values included in this document are for informational purposes
only. The data supporting these valuesmay or may not meet the cmrent acceptance criteria.
**rv-
?'-"* ?S$U&&3fe, "
11678-61
11678-62
100-979
100-980
10163-263
11678-63
11678^4
19713-523
19713-524
34822-6
47332-4
62366-2
* '" . %ActivfrfaBratiott '; '-, , /
92.0
92.0
87.0
87.0
87.0
87.0
87.0
87.0
87.0
87.0
87.0
87.0
118
-------
'iBaiefe2,;=< : ,
-$«0k3 * l "
:;8att$.4
." / jsAft^ti^S'i. -i3
100-784
100-977
10163-241
- fiP&"8^% *V' .. ,.>
100-460
655-456
769-954
5905-526
10163-163
19713-492
34704-435
51036-108
66222-10
^ , 'fiKMbtfe"* ' , ,:
100-461
655-459
769-689
769-841
829-262
1386-599
2935-388
5481-224
5905-248
9779-210
10163-100
19713-91
34704-231
37915-6
51036-71
^ Active &*g?«&0!t * 'v
56.0
56.0
56.0
,> ^f %Aete^rB^Ktot "V
50.0
50.0
50.0
50.0
50.0
50.0
. 50.0
50.0
50.0
\t ', , .-^feAj^a^^^f * ?. ,
48.0
48.0
48.0
48.0
47.5
48.0
48.0
47.5
48.0
48.0
48.0
48.0
48.0
48.0
48.0
119
-------
Stars- ..- f
BWdi 6 : :
Attfe?""
'" =s- 1 1 *
«tt&& ' -
", ; , EPAlft^jHa. / : .:
655-462
7401-213
66222-9
'_:'- - "SaQ^ife^' - CVJ
19713-145
42056-18
^ ! - HSA3U»ffe ? T ; , s
16-157
100-456
239-2364
270-282
572-305
1386-573
7401-216
8845-92
28293-230
33912-1
33955-556
_- . % AcJivelngrctfient : , , , ;
48.7
48.0
48.0
,*"''-, t 'i^^oH^faBSiSiWft&taliiil
EHazmon: 25.00
Diazinon: 25.00
^ * - iSfcAejigeJBBBBmeatt
25.0
25.0
25.0
25.0
25.0
25.0
25.0
25.0
25.0
25.0
25.0
f *" ; * . « %
^i-Jfc^B^ V., '
16-166
100-770
239-2643
869-231
4581-392
7401-441
59144-28
61282-25
/ ** , * -' "5 \ '
% /, - . 9M«ilteivpft
22.4
22.4
22.4
22.4
23.0
22.4
22.4
22.4
120
-------
Batch1)
;ass3i'i&;i
'Jtafe&'&t.
:*,"-, "^A*(»r«K <:v"-"':5
100-469
655-557
10163-104
28293-239
34704-230
.'r^'j *rifeMV>
2935-408
5905-262
19713-95
51036-70
-f i£*£tf.&*t "_-v^
16-119
100-528
192-161
228-177
239-2479
239-2503
538-187
572-292
655-556
829-264
869-139
961-358
1386-648
8378-32
8750-51
8845-95
8845-101
9198-62
10163-116
10404-23
, " v-v< * ^^^bpgAg**',,*. :,' .
143
143
143
143
14.0
- tt t ,%A^i^JEiK^S»^ O 'j-v'. :
143
143
14.0
143
MJ * -.' %Ae^»%t«die« v- -'''"'*
5.00
5.00
5.00
5.00
5.00
5.00
4.54
5.00
5.00
5.00
5.00
5.00
5.00
5.00
5.00
5.00
5.00
5.00
5.00
5.00
121
-------
.Aaui1, -'
19713-263
28293-199
32802-5
33955-557
34704-57
34704-493
34911-13
34911-23
40849-30
42057-107
51036-93
51036-97
53883-51
53883-54
59114-2
' >vl^*.4i$K*>*4fe ^ -
16-118
100-468
228-162
239-2375
538-92
538-204
538-254
538-258
1386-651
7401-222
8378-12
8660-11
8780-54
8780-55
9198-45
9688-89
. - .:" -U -
5.00
5.00
5.00
5.00
5.00
5.00
5.00
5.00
5.00
5.00
5.00
S.OO
5.00
5.00
5.00
#/e " < 5feAefe^^(8f«ltnflt ** * "
2.00
2.00
2.10
2.00
2.88
2.88
3.67
3.20
2.00
2.00
333
3.34
2.10
3.30
333
2.00
122
-------
Mbfe:^:*
;Bas#ti V
?fcfc#M>-Y:
^tefcfei* ' /«
"£**«*,',/&'
W&JM«*-- *' ^
10404-14
19713-264
51036-69
53883-46
Vv r-f fiftiitei:4«o. < ' -^
100-926
239-2671
V-1-1 , J^ie&m1^" -.
3546-27
6218-69
10088-71
19713-317
tf . - ^&W^= <,', , <
239-2630
67572-1
" ; im^£"ik< v. ,^
239-2619
270-260
829-249
769-687
1381-165
4691-142
4691-148
5481-241
5905^74
6409-14
7501-112
8780-56
13926-6
% Ac* ve Indent ' ^
333
2.00
2.00
2.00
,> ' - % Active Ingredient
2.0
2.0
?£ *^ li^i'tP^tegMis^f^ J ;, *J* _v
Diazinon: 0.50
Diazinon: 0.50
Diazmon: 0.50
Diazmon: 0.50 ~
^ ^^^EfebV^HMfr^- ./" :'
0.075
0.058
^ ><-* " ^ Si3j*e tag^K&ei«
Diazinon: 0.50
Diazinon: 18.00
25.00
47.50
Diazinon: 15.52
20.00
40.00
Diazinon: 3 1-60
77.80
Diazinon: 0.500
Diazinon: 15.00
Diazmon: 2.10
6.25
123
-------
lSSia*eh/^ ; *-
'-?' '' -xONK&eg&K.' >V- ^
34704-41
39039-3
39039-6
42056-11
42057-90
45443-1
53883-45
- \r: < *^A^»eb«W!dBH« .: , ' ,- !
48.00
21.40
Diazinon: 30.00
Diazinon: 15.00
25.00
39.00
25.00
124
-------
Appendix H. List of Registrants Sent This Data Call-In
125
-------
126
-------
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Co. Nr.
16
192
228
239
270
538
572
655
769
829
869
961
1381
1386
2935
4581
4691
5905
7401
7501
8378
8780
8845
9198
9688
9779
10163
10404
Case # and Name: 0238,Diazinon
Company Name Agent For
DRAGON CHEMICAL
CORPORATION
VALUE GARDENS SUPPLY, LLC
NUFARM AMERICAS INC.
THE ORTHO BUSINESS GROUP
FARNAM COMPANIES INC
SCOTTS COMPANY. THE
ROCKLAND CHEMICAL CORP.
PRENTISS INC
VALUE GARDENS SUPPLY, LLC
SOUTHERN AGRICULTURAL
INSECTICIDES, INC.
GREEN LIGHT COMPANY
LEBANON SEABOARD
CORPORATION
AGRILIANCE, LLC
UNIVERSAL COOPERATIVES INC
WILBUR ELLIS CO.
CEREXAGRI, INC.
BOEHRINGER INGELHEIM
VETMEDICA, INC.
HELENA CHEMICAL CO
VOLUNTARY PURCHASING BRAZOS ASSOCIATES. INC.
GROUP INC
GUSTAFSON LLC
KNOX FERTILIZER CO INC
PROGRESSIVE LAWN RESEARCH,
INC.
SPECTRUM GROUP
THE ANDERSONS LAWN
FERTILIZER DIVISION, INC.
CHEMSICO
AGRILIANCE. LLC
GOWAN CO
LESCO INC
Address
71 CAROLYN BLVD
PO Box 585
1333 BURR RIDGE PARKWAY. SUITE 125A
PO Box 190
PO Box 34820
14111 SCOTTSLAWNRD
71 CAROLYN BLVD.
C.B. 2000
PO Box 585
PO Box 21 8
PO Box 17985
1600 EAST CUMBERLAND STREET
PO Box 64089
1300 CORPORATE CENTER CURVE -
PO Box 1286
630 FREEDOM BUSINESS CENTER, SUITE 402
PO Box 338 520 S 15TH STREET
225 SCHILLING BOULEVARD. SUITE 300
1806 AUBURN DRIVE
PO Box 660065
PO Box 248 W. CULVER ROAD
PO Box 400 1225 LEHIGH STATION ROAD
PO Box 142642
PO Box 119
PO Box 142642
PO Box 64089
PO Box 5569
1 5885 SPRAGUE ROAD
City & State
FARMINGDALE
ST. JOSEPH
BURR RIDGE
MARYSVILLE
PHOENIX
MARYSVILLE
FARMINGDALE
FLORAL PARK
ST. JOSEPH
PALMETTO
SAN ANTONIO
LEBANON
ST. PAUL
EAGAN
FRESNO
KING OF PRUSSIA
ELWOOD
COLLIERVILLE
CARROLLTON
DALLAS
KNOX
HENRIETTA
ST LOUIS
MAUMEE
ST LOUIS
ST PAUL
YUMA
STRONGSVILLE
Zip
NY 11735
M 64502
IL 605270866
OH 43040
AZ 85067
OH 43041
NY 11735
NY 110012000
M 64502
FL 34220
TX 78217
PA 17042
M 551640089
M 55121
CA 93715
PA' 19406
KS 66024
TN 38017
TX 750071451
TX 75266
IN 46534
NY 14467
M 631140642
OH 43537
M 631140642
M 551640089
AZ 853665569
OH 44136
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0238,Dtazlnon
Co. Nr.
Company Name
Agent For
Address
City ft State
Zip
11556
11678
19713
28293
32802
33955
34704
34911
39039
40849
42056
42057
45443
47000
51036
53883
56984
59144
59623
60255
63210
66222
67572
75082
BAYER HEALTHCARE LLC
MAKHTESHIM CHEMICAL WORKS
LTD
DREXEL CHEMICAL CO
UNICORN LABORATORIES
HOWARD JOHNSON'S
ENTERPRISES INC
FBI/GORDON CORP
LOVELAND PRODUCTS, INC.
HI-YIELD CHEMICAL COMPANY
Y-TEX CORPORATION
ENFORCER PROUCTS.
TRACE CHEMICALS LLC
MORGRO CHEMICAL CO
REESE CITRUS INSULATORS,
INC.
CHEM-TECH LTD
MICRO-FLO COMPANY LLC
CONTROL SOLUTIONS, INC.
CALIFORNIA DEPT OF HEALTH
SERVICES
GROTECINC
CALIFORNIA DEPT OF FOOD AND
AGRICULTURE
CALIFORNIA DEPT OF FOOD AND
AGRICULTURE
PINEAPPLE GROWERS
ASSOCIATION OF HAWAII
MAKHTESHIM-AGAN OF NORTH
AMERICA INC
CONTRACT PACKAGING INC
SUPREME CHEMICALS OF
GEORGIA, INC.
BRAZOS ASSOCIATES. INC.
ACUITY SPECIALTY PRODUCTS GROUP,
INC.
STEVEN E. ROGOSHESKE
REGWEST COMPANY
PO Box 390
551 FIFTH AVE SUITE 1100
PO Box 13327 1700 CHANNEL AVENUE
12385 AUTOMOBILE BLVD.
700 W. VIRGINIA ST STE 222
PO Box 014090 1217 WEST 12TH STREET
PO Box 1286
1806 AUBURN DRIVE
PO Box 1450 1825 BIG HORN AVENUE
1310 SEABOARD INDUSTRIAL BLVD., NW
2320 LAKECREST DRIVE
145 WEST CENTRAL AVE
5888 LK VICTORIA PL
1479 WEST POND ROAD
530 OAK COURT DRIVE
5903 GENOA-RED BLUFF
PO Box 997413
30856 ROCKY ROAD
1220 N STREET
1220 N ST
1116WHITMOREAVE
551 FIFTH AVENUE - STE 1100
10115 HWY 142 N
1535 OAK INDUSTRIAL LANE, SUITE B
SHAWNEE MISSION
NEW YORK
MEMPHIS
CLEARWATER
MILWAUKEE
KANSAS CITY
GREELEY
CARROLLTON
CODY
ATLANTA
PEKIN
SALT LAKE CITY
LAKELAND
EGAN
MEMPHIS
PASADENA
SACRAMENTO
GREELEY
SACRAMENTO
SACRAMENTO
WAHIAWA
NEW YORK
COVINGTON
CUMMINGS
KS 662010390
NY 10176
TN 381130327
FL 33762
Wl 532041548
M 641010090
CO 806321286
TX 750071451
W 82414
GA 30318
IL 615546637
UT 84107
FL 33813
M 55122
TN 38117
TX 775071041
CA 958997413
CO 806319375
CA 95814
CA 95814
HI 96786
NY 10176
GA 30014
GA 30041
-------
Appendix L List, of Available Related Document and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet she:
hup:/Avww.epa.gov/Qpprd001/tonns/
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms, (Note: Form numbers that are bolded can be filled out on
your computer then printed.)
2. The completed fbrm(s)srK>uM be s
3. Mail die 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 tax or e-mail any form containing 'Confidential Breiness
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551 or
by e-mail at wiUiamsjiicole@epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet
at the following locations:
8570-1
5570-4
8570-5
8570-17
8570-25
5570-27
8570-28
8570-30
Application for Pesticide Registration/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
Fotmulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing
httD!//www.eoa.Eov/oi>Drd001/fonns/857P-l4K;(f
httD://www.eoa.eov/ODDrdOO 1 /forms/857P-4,pdf
httD://www.eoa.eov/oiMjrd001/forms/8570-5,p(jf '
httD^/www.ef».eov/ODDrd001/forms/8570-17.Ddf
httD:/Avww.epa.Eov/ODordOO I/forn>s/8. 570-2$,pdf
htro://www.eoa.aov/ODDrdOO 1 /forms/8570-27.ndf
httD://www.eDa.aov/ODDrd001/forms/8570-28Ipdf
httD://www.epa.Eov/ODDrd001/farms/S1570-30.tv1f
129
-------
8570-32
8570-34
J570-35
8570-36
8570-37
Certification of Attempt to Enter into an
Agreement with other Registrants for Development
ofData
Certification with Respect to Citations ofData
(PR Notice 98-5)
Data Matrix (PR Notice 98-5)
Summary of the Physical/Chemical Properties (PR
Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (PR Notice 98-1)
http://www.ena.eov/oaprdOO 1 /fonngftj57P-32,pdf
httD://www.et)a_eov/oDppmsdl/PR Notice£/pr
-------
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' website.
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.
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
website.
131
-------
4. The National Pesticide Telecommunications Network (NPTN) can provide information on active
ingredients, uses, toxicology, and chemistry of pesticides. You can contact NFTN by telephone at
(800) 858-7378 or through their website: ace.orstedu/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; and
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 petiuOTnumrjer 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 chemical
abstract system (CAS) number if one has been assigned
132
-------
-------
------- |