vvEPA
United Statw
Environmental Protection
Agency
Office of
Pesticides end Toxic Substances
Washington DC 20460
Pesticides
540/RS-89-016
Guidance for the
Reregistration of
Pesticide Products
Containing DIAZINON
as the Active Ingredient
-------
OMB Control No. 2070-0057
Expires November 1989
REGISTRATION STANDARD
FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
DIAZINON
[057801]
AS THE ACTIVE INGREDIENT
[CASE NUMBER-0238]
[CAS NUMBER 333-41-5]
DECEMBER 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, B.C. 20460
U.S. Environmental Protection Agency
Region V, Library
230 South Dearborn Street
Chicago, Illinois 60604
-------
TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by this Standard 3
A. Description of Chemical
B. Use Profile
C. Registration History
III. Agency Assessment 8
A. Summary
B. Health Effects Assessment
C. Ecological Effects Assessment
D. Environmental and Human Exposure Assessment
E. Tolerance Reassessment
IV. Regulatory Position and Rationale 30
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 50
VI. Requirement for Submittal of Generic Data 52
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Registrant requests regarding data
requirements and Agency responses
F. Test protocols and standards
G. Procedures for requesting a change in protocol
H. Procedures for requesting extensions of time
I. Data Format and Reporting Requirements .
J. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submittal of Product-Specific Data 58
VIII. Requirement for Submittal of Revised Labeling ... .59
IX. Instructions for Submittal 59
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End use products (multiple active)
E. Intrastate Products
-------
APPENDICES
I. DATA APPENDICES 63
Guide to Tables
Table A
Table B
Table C
II. LABELING APPENDICES 153
Summary of label requirements and table
40 CFR 156.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. BIBLIOGRAPHY APPENDICES 167
Guide to Bibliography
Bibliography
IV. FORMS APPENDICES 185
EPA Form 8580-1 FIFRA 3(c)(2)(B) Summary Sheet
EPA Form 8580-3 Generic Data Exemption Statement
EPA Form 8580-4 Product Specific Data Report
EPA Form 8580-6 Certification of Attempt to Enter
Into an Agreement with Other
Registrants for Development of
Data
11
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
a. i.
ARC
CAS
CSF
DESHC
EEC
EP
EPA
FIFRA
FFDCA
GC
GLC
LC50
LD50
LEL
MPI
An acceptable daily intake of pesticide residue
based on a complete data base.
Active ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Confidential Statement of Formula
Division of Endangered Species & Habitat
Conservation
Estimated Environmental Concentration. The
estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
End Use Product
U.S. Environmental Protection Agency
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Gas Chromatography
Gas Liquid Chromatography
Median lethal concentration - a statistically
derived concentration of a substance that can be
expected to cause death in 50% of test animals. It
is usually expressed as the weight of substance per
weight or volume of water, air, or feed, e.g., mg/1
or ppm.
Median lethal dose - a statistically derived single
dose than can be expected to cause death in 50% of
the test animals, when administered by the route
indicated (oral or dermal). It is expressed as a
weight of substance per unit weight of animal,
e.g., mg/kg.
Lowest Effect Level
Maximum Permissible Intake
111
-------
MRID
MP
NPDES
NOEL
OPP
PAD I
ppm
RfD
TMRC
Master Record Identification (number). EPA's
system of recording and tracking studies submitted
to the Agency.
Manufacturing Use Product
National Pollutant Discharge Elimination System
No Observed Effect Level
Office of Pesticide Programs
Provisional Acceptable Daily Intake
Parts per million
Reference Dose: An estimate of a daily exposure to
the human population (including sensitive
subgroups) that is likely to be without an appre-
ciable risk of deleterious effects during a
lifetime. The reference dose is a replacement term
for the term acceptable daily intake (ADI).
Theoretical Maximum Residue Contribution: An
estimate of dietary exposure obtained by
multiplying residue tolerance levels for a given
pesticide by the average daily per capita food con-
sumption figure, then adding the exposure figure
for each crop. The TMRC is usually expressed in
terms of mg/kg of food.
IV
-------
I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be
reviewed and standards set for compliance with FIFRA. The
standards are applicable to reregistration and future
applications for registration of products containing the same
active ingredient. Each registrant of a product containing an
active ingredient subject to this Standard who wishes to
continue to sell or distribute that product must bring his
product and labeling into compliance with FIFRA, as
instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA
identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to
protect man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request,1 focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and
conclusions from available data in its files pertaining to
the pesticide active ingredient. However, during the review
of these data the Agency is also looking for potential
hazards that may be associated with the end use products that
contain the active ingredient. The Agency will apply the
1The scientific reviews and Compendium of Acceptable
Uses may be obtained from the OPP Public Docket, Field Operations
Division, telephone number (703) 557-2805 or by writing EPA, Public
Information Branch, FOD, 401 M Street, S.W., Washington, DC 2046C.
-------
provisions of this Registration Standard to end use products
if necessary to protect man and the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their
registrations in compliance with FIFRA. These steps may
include:
1. Submittal of data in support of product
registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154 to
examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency may
propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI)
provisions of FIFRA sec. 3(c)(2)(B) to require that
registrants submit data to answer our questions regarding the
chemical, toxicological, and environmental characteristics
and fate of a pesticide. This Registration Standard lists the
data EPA believes are necessary to resolve our concerns about
this pesticide. These data are listed in the Tables A, B, and
C in Appendix I. Failure to comply with the DCI requirements
enumerated in this Registration Standard may result in
issuance by EPA of a Notice of Intent to Suspend the affected
product registrations.
-------
Registrants are reminded that FIFRA sec. 6(a)(2)
requires them to submit factual information concerning
possible unreasonable adverse effects of a pesticide at any
time that they become aware of such information. Registrants
must notify the Agency of any information, including interim
or preliminary results of studies, if that information
suggests possible adverse effects on man or the environment.
This requirement is independent of the specific time
requirements imposed by EPA for submittal of completed
studies called in by the Agency and continues as long as the
products are registered under FIFRA.
II. CHEMICAL COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICAL
The following chemical is covered by this Registration
Standard:
Common name: Diazinon
Chemical name: 0,0-Diethyl 0-(2-isopropyl-6-methyl-
4-pyrimidinyl) phosphorothioate.
Other Chemical Nomenclature: 0,0-Diethyl 0-(2-isopropyl
-6-methyl-pyrimidin-4-yl) phosphorothioate.
CAS Number: 333-41-5
ENT Number: 19507
OPP (Shaughnessy) Number: 057801
Empirical Formula: C12H21N2°3PS
Molecular Weight: 304.3
Trade names: Spectracide, D.Z.N., Knox-Out,Alfa-tox,
Saroles, Basudin, AG-500.
Description of physical characteristics of chemical 2
Color: amber and brown
Physical State: liquid
Odor: mild, sweet, aromatic
Melting Point: liquid at 25°C
Boiling Point: 83-84°C at 0.002 mm Hg
Specific Gravity: 1.12 g/ml at 20°C
Solubility: 60 ppm in water at 25°C and 40 ppm in
water at 20°C .
Vapor Pressure: 1.4 x 10~4 mm at 20°C
Partition Coefficient: pK= 4.4 at 20°C
2 Physical/chemical properties are for the technical
products, Note: Diazinon technical products are marketed as
"stabilized technicals"; therefore, these products are actually
formulation intermediates (manufacturing use products).
-------
B. USE PROFILE
Type of Pesticide: Insecticide
Pests Controlled: soil insects, such as cutworms,
wireworms, and maggots. Pests affecting fruits, vege-
tables, tobacco, forage, field crops, range, pasture
grasslands, and ornamentals. Many household insects
including cockroaches. Several turf pests including white
grubs and chinch bugs. Seed treatment and fly control.
Fleas and ticks on domestic pets.
C. REGISTERED USES:
[Use pattern groupings; for specific crops and use
patterns refer to the EPA Compendium of Acceptable Uses]
TERRESTRIAL TERRESTRIAL GREENHOUSE GREENHOUSE
FOOD CROPS NON-FOOD CROPS FOOD CROPS NON-FOOD CROPS
Vegetable Groups Tobacco, Cabbage, Ornamental
root & tuber ornamental cantaloupe, Plants.
bulb,leafy, plants cauliflower,
brassica leafy, trees and turf. cucumber,egg
legume, legume plant, mushroom
foliage, NON CROP,WIDE houses, summer
cucurbits. AREA, & GENERAL squash,
OUTDOOR watermelons,
Fruit Groups TREATMENT: zucchini.
citrus,pome, barrier strips,
stone, small ditch banks,non-
fruit and crop areas,
berries. roadsides and
-------
Tree Nut Group, wastelands.
Cereal Grains
Group.Forage and
Fodder Grasses,
Non-Grass
Animal Feed
INDOOR DOMESTIC OUTDOOR
Pets and Households;
Domestic domestic
Animals. dwellings.
Animals and
Their Man-made
Premises.
HousehoId(domes-
tic dwellings
indoor.
Commercial and
Industrial Uses.
Food/Feed
Processing
Facilities.
-------
Annual Usage: 10 million pounds active ingredient
(1985 data).
Predominant Use(s)3: Agricultural market 40% and Home
and Garden uses 20%. Professional app-
lication such as golf courses represented 40%.
Mode of Activity: Cholinesterase inhibition.
Formulation Types Registered: Dusts, emulsifiable concen
trates, granules, impregnated materials,
liquids, microencapsulated, pressurized
sprays, soluble concentrates, wettable
powders.
Method(s) of Application: Aerosols, sprays, pet collars,
insect tape, ear tags, ground blast, aerial,
and soil incorporated.
C. REGISTRATION HISTORY
Year of Initial Registration: 1956
Basic Producers: Ciba-Geigy, Trans Chemic Industries, Inc.,
and Makhteshim Agan (America) Inc.
End-use Registrants: 411
Number of Registrations: 1,169 Section 3
206 24-C
In January 1986, The Agency initiated a Special Review of
diazinon's uses on golf courses and sod farms based on acute
toxicity risks to avian species. This concern was based on
available laboratory data on acute and dietary toxicity, exposure
data, field studies, and reported bird kill incidents associated
with these two sites of diazinon application. After assessing
these risks and comparing them to the benefits afforded by dia-
zinon on these sites, the Agency concluded on September 24, 1986
that the risks by exceeding the benefits were unreasonable. The
Agency cancelled the registrations for these two use patterns.
This Special Review decision has been the subject of two
completed legal appeals and is currently the subject of a third
legal appeal in progress. During this current appeal, the golf
course and sod farm uses remain cancelled.
Precent usage based on use information developed
by EPA 1985. Precent usage excluding the cancelled
uses are not currently avialable.
-------
Data-Call-in Notices Issued
The Agency has issued the following 3(c)(2)(B)
Data-Call-in (DCI) Notices:
Date Issued Data Required Due Date Status
2-18-83 Teratogenicity 5/85 See section III-B
(one species)
7-24-84 Groundwater 6/87* See section III-D
[hydrolysis,
photodegradat i on
on soil and in water,
aerobic soil, ana-
erobic soil and
aquatic metabolism,
mobility, (field)
dissipation soil]
Product chemistry.
5-30-86 Reentry 12/87 See section III-D
[foliar
dissipation,
soil dissipation,
dermal exposure,
inhalation exposure]
5-01-87 Comprehensive 12/91* Under review
[environmental
fate, fish and
wildlife, product
chemi stry-mup's
and technical's
only, residue
chemistry,and
toxicity]
* Due date of final submission.
-------
III. AGENCY ASSESSMENT
The Agency has reviewed all data in Agency files as of May
1987 supporting the registration of diazinon. Product
chemistry data submitted in response to the 1987 DCI on the
registered manufacturing use products and plant phytotoxicity data
have also been reviewed. Other data required by the 1987 DCI have
been received and are currently under review (for specific data
under review refer to data tables in Appendix I). This section
discusses the Agency's scientific findings and conclusions based
on these data.
A. SUMMARY
Currently registered manufacturing use products have been
determined to be substantially similar but not identical. The
toxicological similarity between the manufacturing use products
cannot be ascertained. The Agency is requiring toxicity data on
each manufacturing use product to determine toxicological
similarity.
Available data on manufacturing use products characterize
diazinon as moderately toxic on an acute oral basis and mildly
toxic on an acute dermal and inhalation basis. Diazinon did not
elicit dermal or eye irritation when tested. Diazinon elicited
positive responses for dermal sensitization in about 10% of the
human volunteers tested.
Diazinon is not oncogenic in the Fisher F344 rat or in the
B6C3F1 mouse.
Diazinon does not induce developmental toxicity in rats at
dose levels up and including 100 mg/kg/day (highest dose tested).
Decreased food consumption and body weight gain in the treated
dams were observed at 100 mg/kg/day.
Diazinon does not induce developmental toxicity in rabbits at
dose levels up and including 100 mg/kg/day (highest dose tested).
Significant maternal toxicity was observed at 100 mg/kg/day.
Based on acceptable laboratory data, technical diazinon is
characterized as very highly toxic to waterfowl on an acute oral
basis, with an LD50 of 6.38 mg/kg for mallard ducks. Avian
dietary studies characterized diazinon as highly toxic to upland
game birds with a dietary LC50 of 245 ppm for bobwhite quail.
Supplemental data characterize diazinon as very highly toxic to
waterfowl with a dietary LC50 of less than 47 ppm for mallard
ducks.
-------
Granular end-use formulations of diazinon are characterized
as very highly toxic to waterfowl, upland game birds and songbirds
on an acute oral and dietary basis.
Technical diazinon and its end-use formulations are
characterized as very highly toxic to aquatic organisms.
It is considered highly toxic to non-target insects.
Diazinon degrades rapidly under aerobic, anaerobic,
aquatic anaerobic and sterile soil conditions.
Microbial degradation appears to be the major pathway for the
degradation of diazinon. The most probable mechanism responsible
for degradation under sterile and anaerobic soil conditions
appears to be chemical hydrolysis in acidic soils. Supplemental
hydrolysis data indicate the diazinon is stable with respect to
hydrolysis at pH 7 and 9 but hydrolyzes in non-sterile water with
pH 5.
The major soil degradate is oxypyrimidine. Oxypyrimidine is
more persistent than diazinon under aerobic, sterile, and
anaerobic aquatic soil conditions.
Diazinon with a 4 day EC50 of 4.14 mg/L and a 7 day EC50 of
3.7 mg/L may be characterized as moderately toxic to freshwater
green alga. Diazinon caused greater than 25% detrimental effect
in plant vigor in tomatoes, cucumbers, onions, lettuce, and
carrots. Diazinon caused greater than 25% detrimental
effect in seed germination in oats, tomatoes, and carrots. No
detrimental effect was seen for seedling emergence.
B. HEALTH EFFECTS ASSESSMENT
1. Acute Toxicity
Available data on manufacturing use products characterize
diazinon as moderately toxic on an acute oral basis (LD50=618
ing/kg, toxicity category III) and mildly toxic (toxicity category
III) on an acute dermal and inhalation basis (LD50 >2,000 mg/kg
and LC50= 3.5 mg/L respectively). Technical diazinon did not
elicit dermal or eye irritation when tested (toxicity category
IV). Technical diazinon elicited positive responses for dermal
sensitization in about 10% of the human volunteers tested.
There are no acceptable acute delayed neurotoxicity studies
available. Since diazinon is an organophosphate insecticide it
must be tested for delayed neurotoxicity.
-------
2. Subchronic Toxicity
The Agency does not have any acceptable subchronic data to
support registration of products containing diazinon. A full
battery of subchronic testing is required.
3. Oncogenicity
Acceptable oncogenicity studies have been performed using
diazinon in the Fisher F344 rat and in the B6C3F1 mouse. These
studies are discussed below:
a. NCI/NTP Diazinon Oncogenicity Study in the Fisher F344 Rat
In this study, diazinon (purity 98%) was administered to
F344 rats via the diet at dosage levels of 400 and 800 ppm
(approximately 20 and 40 mg/kg/day respectively) for 103 weeks
followed by a 2 week observation period. Dose levels were
selected following a subchronic range-finding study which showed
body weight loss at 1600 ppm (80 mg/kg/day) (in females) and some
deaths at 3200 ppm (160 mg/kg/day).
NCI/NTP concluded that histopathologic examination provided
no convincing evidence for the carcinogenicity of diazinon in
F344 rats under the conditions of this bioassay.
The Agency agrees with NCI/NTP that diazinon is not
carcinogenic in Fisher F344 rats.
b. NCI/NTP Diazinon Oncogenicity Study in the B6C3F1 Mouse
In this study, diazinon (purity 98%) was administered via the
diet to B6C3F1 mice. There were 25 of each sex for the concurrent
control group and 50 of each sex for the groups dosed with 100 and
200 ppm (approximately 15 and 30 mg/kg/day respectively). The
mice were dosed with diazinon for 103 weeks. These dose levels
were selected on the basis of a preliminary subchronic study which
showed that 800 ppm (approximately 120 mg/kg/day) resulted in
weight loss,in females, and 1600 ppm (approximately 240 mg/kg/day)
resulted in deaths in males and females.
The study indicated that diazinon was not associated with
increased incidence of neoplasms. It was concluded that under the
conditions of this bioassay diazinon was not oncogenic in mice at
dose levels up and including 200 ppm (approximately 30 mg/kg/day).
4. Metabolism
The Agency does not have any acceptable metabolism data to
support registration of products containing diazinon. Metabolism
data are required.
10
-------
5. Teratogenicity
Acceptable teratogenicity studies have been performed using
diazinon in the New Zealand strain rabbit and in the Sprague-
Dawiey rat. These studies are discussed below:
a. Teratogenicity in Rabbits
In this study, New Zealand strain rabbit does were given,
single oral doses of diazinon via gavage on days 6 through 18 of
gestation. Doses employed were 0 (control), 7, 25, and 100
mg/kg/day. Significant maternal toxicity was observed in the
highest dose group, 100 mg/kg/day. There were no indications of
developmental toxicity in any of the dose levels studied.
The Agency concluded that diazinon does not induce develop-
mental toxicity in rabbits at dose levels up to and including 100
mg/kg/day.
b. Teratogenicity in Rats
In this study, Sprague-Dawley strain rat dams were given
single daily doses of diazinon, via oral gavage, on days 6 through
15 of gestation. Doses employed were 0 (control), 10, 20, and 100
mg/kg/day. On day 20 dams were sacrificed and the pups assessed
for signs of developmental toxicity. Signs of maternal toxicity
in the dams included decreased food consumption and body weight
gains. Developmental toxicity was not observed in this study at
dose levels up to and including 100 mg/kg/day.
6. Reproduction
The Agency does not have an acceptable multi-generation
reproduction study to support the registration of products
containing diazinon. A study in the rat is required.
11
-------
7. Mutagenicity
Diazinon was evaluated along with 17 other pesticides for
mutagenic or genotoxic effects in the following assays:
o Reverse mutation in Salmonella typhimurium strains TA1535,
TA1537, TA1538, TA98, and TA100 and in Escherichia coli WP2
uvrA.
o Induction of mitotic recombination in the yeast
Saccharomyces cerevisiae D3.
o Relative toxicity assays in DNA repair-proficient and
deficient strains of E. coli (strains W3110 and P3478,
respectively) and of Bacillus subtilis (strains H17 and M45,
respectively).
o Unscheduled DNA synthesis in human fibroblasts (WI-38
cells).
The Agency concluded that diazinon was not mutagenic under
the conditions of these assays. Diazinon was, however, reported
in the literature to be positive in a sister chromatid exchange
assay in mudminnows.
The Agency is requiring that a structural chromosome
aberration study (ie., a mouse micronucleus assay) and additional
sister chromatid exchange assays using both in vivo and in vitro
(with and without metabolic activation) be submitted.
The Agency is also requiring a summary table of all readily
available studies conducted on diazinon for mutagenicity and
genotoxic effects including literature references.
C. ECOLOGICAL EFFECTS ASSESSMENT
1. Avian Species
a. Manufacturing Use Formulations:
Based on acceptable laboratory data, diazinon is charac-
terized as very highly toxic to waterfowl on an acute oral
basis, with an LD50 of 6.38 mg/kg for mallard ducks. Avian
dietary studies characterized diazinon as highly toxic to upland
game birds with a dietary LC50 of 245 ppm for bobwhite quail.
Supplemental data characterize diazinon as very highly toxic
to waterfowl with a dietary LC50 of less than 47 ppm for mallard
ducks. All birds died at the lowest test level. A new dietary
study in mallard is required to determine the actual LC50 value.
12
-------
b. End Use Formulations:
Based on acceptable laboratory data, the following diazinon
formulations were characterized for acute oral toxicity;
Avian Formulation Percent
Species Type a.i.
House Sparrow Granular 14
Redwinged
Blackbird Granular 14
Bobwhite
Quail Granular 14
Bobwhite
Quail Microencap- 23
sulated
LD50
(mg ai/kg)
2.5
1.8
8.0
108.5
Toxicity
Characterization
Very highly toxic
Very highly toxic
Very highly toxic
Highly toxic
A dietary LC50 study was conducted on Japanese quail using
a 48% a.i. emulsifiable concentrate formulation. Results of this
study characterized this formulation as highly toxic, with a
dietary LC50 of 101 ppm for this species of upland game bird.
Avian dietary studies are required on songbirds (preferably
brown-headed cowbird) and on waterfowl (preferably the mallard
duck).
2. Aquatic Organisms
a. Manufacturing Use Formulations:
Based on acceptable laboratory data, diazinon was
characterized for acute toxicity in the following aquatic
organisms;
Aquatic Percent
Species ai
Warmwater Fish:
Bluegill sunfish 92
Bluegill sunfish 92
Bluegill sunfish 91
Coldwater Fish:
Rainbow Trout 89
Rainbow Trout 91
Lake Trout 92
Cutthroat Trout 92
Freshwater Invertebrates:
Daphnia magna 89
Daphnia pulex 89
Gammarus fasciatus 89
Pteronarcys 89
Simocephalus 89
LC50
(ug/L!
168
460
136
90
400
602
1700
0.96
0.8
0.2
2.5
1.4
Toxicity
Characterized
Highly Toxic
Highly Toxic
Highly Toxic
Very highly toxic
Highly toxic
Highly toxic
Moderately toxic
Very highly toxic
Very highly toxic
Very highly toxic
Very highly toxic
Very highly toxic
13
-------
Estuarine Organisms:
Sheepshead Minnow >89 1400 Moderately toxic
b. End Use Formulations
Based on acceptable laboratory data, the following diazinon
formulation was characterized for acute toxicity;
Aquatic Percent Formulation LC50 Toxicity
Species ai Type (ug/L) Characterized
Warmwater Fish:
Bluegill sunfish 23 microencap- 512 Highly toxic
sulated
Coldwater Fish:
Rainbow Trout 23 microencap- 635 Highly toxic
sulated
Freshwater Invertebrate:
Daphnia magna 23 microencap- 0.522 Very highly toxic
sulated
3. Nontarget Insects
a. Pollinators
1. Manufacturing Use Formulations:
Based on the following acceptable laboratory data, there are
sufficient data to characterize diazinon as highly toxic to honey bees
(Apis mellifera). No additional data are required.
Species LD50 Method of
Tested (ug/bee) Testing
Honey Bees 0.372 Contact LD50
Honey Bees 0.22 Contact LD50
Honey Bees 0.20 Oral LD50
2. End Use Formulations:
Based on acceptable laboratory data, two formulations of
diazinon (40% wettable powder and 16% emulsifiable concentrate)
were characterized as highly toxic through residual contact,
feeding, direct contact and fumigation. No additional data are
required.
b. Nontarget Soil and Surface Invertebrates
Based on acceptable data, two formulations of diazinon (25%
and 50% wettable powder) were characterized as highly toxic to
predaceous mites, parasitic wasps, and predaceous beetles, when
used at standard field rates.
14
-------
4. Non-Target Area Phytotoxicity
a. Vegetative Vigor
Tier I non-target phytotoxicity studies were conducted to
determine the effects of diazinon technical applied at the
maximum rate of 10 Ib ai/A, on the vegetative vigor of soybean,
lettuce, carrot, tomato, cucumber, cabbage,, oat, ryegrass,
corn, and onion. A single treatment of diazinon was applied.
Treatment with diazinon resulted in a 25% or greater detrimental
effect on vegetative vigor, as measured in plant height, on onion,
cucumber, and tomato. Tier II testing is required in tomato,
onion, lettuce, and carrot.
b. Seed Germination/Seedling Emergence
Tier I non-target phytotoxicity studies were conducted to
determine the effects of diazinon technical on the seed
germination and seedling emergence and subsequent early growth of
soybean, lettuce, carrot, tomato, cucumber, cabbage, oat, ryegrass
corn, and onion. In the seed germination study, ten seeds of each
crop were placed in a plastic petri plate containing two pieces of
Whatman #3 filter paper. Seven milliliters of a 30 ppm diazinon
solution was added to each plate and the radicle length was
measured. Treatment resulted in a 26, 27, and 43% decrease in
radicle (embryonic root of a seedling) length in oat, tomato, and
carrot seeds respectively.
A greater than 25% detrimental effect level was observed in
oat, tomato, and carrot, based on effect on radicle length, in
the seed germination study. Tier II testing is required in
tomato, carrot, and oat.
In the seedling emergence study, a plexiglass template was
used to uniformly plant ten seeds of each crop group in plastic
pots. Diazinon was applied at the rate of 10 Ib ai/A. Seedling
height, percentage of seedling emerged, and phytotoxicity ratings
were recorded 7, 14, and 20 days after treatment. Treatment
resulted in no observable phytotoxic effects on any of the crops
treated. Onion was the most sensitive crop tested with a mean
phytotoxicity rating of 0.4 at day 20. The percent effect
on the percentage of seedlings emerged at day 20 ranged from a 6%
increase in soybean to an 5% decrease in onion. The percent
effect seedling height at day 20 ranged from a 6% increase in oat
to an 18% decrease in onion.
Detrimental effects were < 25% for seedling emergence, no
additional testing is required.
15
-------
c. Aquatic Plant Growth
Technical diazinon was characterized as moderately toxic to
freshwater green alga (Selenastrum capricornutum) with a 4-day
EC50 of 4.14 mg/L (or 4.14 ppm) and a 7-day EC50 of 3.7 mg/L (or
3.7 ppm).
Diazinon when applied to turf at a maximum application rate
of 17.1 Ib ai/A (assuming 10 acres treated with a 2% runoff into a
large l acre pond 0.5 feet deep) would result in a EEC of 2.5
ppm. The EEC does not exceed the 4 day or 7 day EC50 values for
freshwater green algae.
Diazinon when applied to cranberries at the recommended
application rate of 3.0 Ib ai/A (assuming direct application
to water 0.5 feet deep) would result in a EEC of 2.2 ppm. The
EEC does not exceed the EC 50 value for freshwater green algae.
No further testing is required.
ECOLOGICAL RISK ASSESSMENT
Avian Hazard
Diazinon's highest application rates are generally on citrus
and vegetables (e.g., beans, beets, carrots, cabbage, radishes,
turnips, corn, lettuce, peas, and tomatoes) with maximum rates up
to 10 Ib ai/A. Orchard crops (e.g., almonds, apples, pears) have
maximum rates up to 6 Ib ai/A. Grass sites have rates as high as
11 Ib ai/A.
Lawns, Parks, and other Grassy Sites
Avian risk that were identified for diazinon use on sod farms
and golf courses appear to be substantially similar to avian
risks when diazinon is used on other grassy sites such as home
lawns, athletic fields, parks, etc. Bird exposure to residues of
diazinon at these sites is also expected to occur.
Residue data on turf grass show average residue values per
unit dose to be 53 ppm per application of 1 Ib active ingredient
followed by irrigation with 0.25 inches of water. A typical
application rate of 4 Ib ai/A would result in residues estimated
at 212 ppm, which exceeds 1/5 the avian subacute dietary LC50
value.
A record of at least 50 bird kill incidents on grassy sites
such as lawns and parks supports the concern that hazardous
exposure regularly and routinely occurs. In total, over 80 bird
kill incidents associated with diazinon have been reported to the
Agency.
16
-------
Agricultural and Other Sites
A. Feeding
Avian dietary exposure to diazinon occurs when birds feed on
grass, roots, seeds, nuts, grains, fruits, and/or the inverte-
brates at the site of application. The average residue per unit
dose is 33 ppm. A typical application rate of 6 Ib ai/A would
result in residues estimated at 198 ppm, which exceeds 1/5 the
avian subacute dietary LC50 value. Dermal exposure to diazinon
residues may also occur as they feed.
B. Exposure in rainwater or irrigation puddles
Exposure to high concentrations of diazinon in water may also
occur. Rain or irrigation (watering in) after diazinon
application may result in the formation of pools of contaminated
water (puddling) which poses an additional hazard to birds. Irri-
gation is recommended by the label for control of certain soil
inhibiting pests. If the water is not immediately absorbed by the
soil, puddles with high concentration of diazinon may form.
Bird kills from diazinon applications have been associated
with irrigation and puddling. The Agency is concerned that even
if applicators comply with the label directions, diazinon may
still pose a hazard, because of the puddling effects.
C. Ingestion of diazinon granules
In addition to the potential hazard from the exposure to
residues on food items, birds may accidentally ingest granules
because the granules may be mistaken for dietary grit. Diazinon
granules are within the size range of grit for birds, and
ingestion of only a few granules has been shown to be lethal to
certain bird species. Diazinon granules are very highly toxic to
birds: one granule of a 14.3% ai end-use product killed 40% of
the test House Sparrows and 5 granules killed 100% of the test
Red-winged Blackbirds.
Because only a few granules are needed to kill birds,
residues in terms of number of granules would exceed 1/5 the
LC50 under all application rates and practices.
Over 80 bird kill incidents associated with use to diazinon
have been reported to the Agency. The record of kills, which
includes application made by trained pesticide applicators,
includes grass sites, orchards, and other agricultural sites. The
kills are reported from States throughout the United States and
occur throughout the year. Waterfowl were frequently involved but
23 species in total have been reported as killed as a result of
exposure to diazinon.
17
-------
Aquatic Hazard
The Agency has reviewed valid aquatic studies on diazinon and
some of its formulations. These studies characterize diazinon as
moderately to very highly toxic to fish and highly toxic to
aquatic invertebrates.
The Agency is concerned about the potential hazard of
diazinon to aquatic organisms. Eight fish kills that implicate
diazinon have been reported to the Agency. In most situations
misuse appears to have occurred. In a few instances diazinon
residues were found in the fish samples analyzed. The reported
fish kills include a loss of 1,150 fish in Westwood, Pennsylvania;
loss of 50 fish in Chester County, Pennsylvania; loss of 1,210
fish in Honolulu, Hawaii; loss of over 100 Cutthroat Trout in the
Hood River, Oregon; loss of over 200 Rainbow Trout in Milton-
Freewater, Oregon; loss of 35,000 suckers and sticklebacks in
Sonia Country, Michigan; loss of 20-25 fish in Sacramento,
California; and a non-quantified loss of fish in Grove, Oklahoma.
Drift and/or runoff from application to agricultural and
home sites may pose a hazard to aquatic organisms. Additional
data are required to assess these potential hazards to aquatic
organisms.
Endangered Species
Due to diazinon's demonstrated toxicity to nontarget species
and its intended use patterns, diazinon has been identified
by the Division of Endangered Species and Habitat Conservation
(DESHC), U.S. Fish and Wildlife Service (FWS), as being likely to
jeopardize the continued existence of certain endangered species
when used on range and pastureland, grain crops, soybeans, and
sorghum.
In addition to the sites previously discussed, diazinon was
identified by DESHC, U.S. Fish and Wildlife Service, as
jeopardizing the continued existence of the following species:
Mohave tui chub (Cial bicolor mohavenis) and the Hawaiian goose
(Neoschen (= Branta) sandvicensis) when used on golf courses and
sod farms.
Other species, listed below, were identified by DESHC as
being adversely affected4 by diazinon's golf and sod farms uses:
4 "Adversely affected" - as defined by the Division of
Endangered Species and Habitat Conservation, FWS, means
that some individuals may be killed but the species
survival is not at stake.
18
-------
Brown pelican (Pelecanus occidentalis)
Alabama Beach Mouse (Peromyscus polionotus ammobates)
Oregon Silverspot butterfly (Speryeria zerene hippolyta)
June Sucker (Chasmistes liorus)
San Francisco Garter snake (Thamnophis sirtallis
tetrataenia)
For all other registered uses of diazinon that may affect
federally listed endangered species the Agency will formally
consult with the Division of Endangered Species and Habitat
Conservation (DESHC), U.S. Fish and Wildlife Service.
D. ENVIRONMENTAL FATE and EXPOSURE ASSESSMENT
Hydrolysis
Supplemental data indicate that hydrolysis of diazinon is
slow at a pH of 7 & 9 and faster at a pH of 5 in non-sterile
water. Therefore hydrolysis is expected to slow in sterile water
at a pH 7 and 9. Diazinon appears to be more stable at a pH of 7
with a half life of over a month. Although definitive half-life
values cannot be determined from available data, the rate of
hydrolysis could be attributed to microbial degradation in non-
sterile water.
Photodegradation in Soil
l^C Diazinon degrades in sandy loam soil with a half-life of
17.3 hours (14.7 days in the dark) when exposed to natural sun-
light. The major degradate, oxypyrimidine, was detected at
maximum concentrations of 23.72% (32.6 hours) after exposure to
sunlight and 17.40% (216 hours) in the dark controls. The
degradate 2-(1'-hydroxy-1'-methyl)ethyl-4-methy1-6-hydroxy-
pyrimidine was formed only under natural sunlight at a level of
36% after 8 hours. An unidentified degradate accounted for about
7% of the applied material as a result of non-photolytic
degradation since it was also present in the non-exposed samples.
No additional data are required.
Soil Degradation
Diazinon degrades rapidly under aerobic, anaerobic, aquatic
anaerobic and sterile soil conditions with the following half-
lives:
Aerobic 31.2 days
Anaerobic 34.3 days
Aquatic 4.0 days*
anaerobic
Sterile 46.0 days
19
-------
* The faster degradation of diazinon under this condition might
be attributed to hydrolysis under the acid aqueous conditions of
the study.
Microbial degradation appears to be the major pathway for the
degradation of diazinon; however as demonstrated by the degrada-
tion half-lives under the various soil conditions, degradation
continues in sterile and anaerobic soil conditions, which
represent conditions of reduced microbial activity. The most
probable mechanism responsible for degradation under sterile and
anaerobic soil conditions appears to be chemical hydrolysis in
acidic soils.
Under neutral and alkaline conditions, diazinon could be
expected to persist longer in anaerobic systems where the main
pathway of degradation is chemical as opposed to microbial.
Oxypyrimidine, the major soil degradate, is more persistent
than diazinon under aerobic, anaerobic, and aquatic anaerobic
soil condition reaching the following levels as percent of applied
diazinon:
Aerobic 95 days accounting for 67% of the
original 14C dose.
Anaerobic 30 days accounting for 12.7% of the
original 14C dose.
Aquatic 15 days accounting for 54% of the
Anaerobic original 14C dose.
A second degradate was identified as 2-(1-hydroxyl-l-methyl)
ethyl-4-methyl-6-hydroxypyrimidine, differing from oxypyrimidine
only by an alcohol group. It reached a maximum concentration in
6 months accounting for 12.8% of the original 14C dose. Two
additional unknown degradates were observed. They were not ident-
ified as they formed in amounts <1.0% of the original 14C dose in
the aerobic and anaerobic soil study systems.
The data requirements for aerobic, anaerobic and aquatic
anaerobic soil metabolism (laboratory) studies have been
fulfilled. Additional data are required for aerobic aquatic soil
metabolism.
Leaching and Adsorption/Desorption
In an acceptable unaged soil column leaching study, residues
of diazinon were observed in four soil types; sand, sandy loam,
silt loam, and clay. Approximately 81% of the applied unaged
radio-active diazinon residues leached through a 30 cm Maryland
sand column, 16% through a Maryland clay column, 6% through a
Mississippi silt loam column, and 17.5% through a California
20
-------
sandy loam column with the application of 50.8 cm of water.
Oxypyrimidine, the major degradate, was the primary component in
the leachates of all soil types. The parent diazinon was present
in each soil type but only in small amounts.
In an aged soil column leaching study, residues of diazinon
were observed in the leachate of a 30 cm sandy soil column at a pH
of 7.8 when leached with 50.7 cm of water. About 32.7% of the
applied material leached through the Collomeby sand soil column
and 25.3% through the sandy loam soil column. Most of the
leaching occurred with the initial application of less than 30 cm
of irrigation. In addition to the primary degradate, oxypyrimi-
dine, another major degradate, 2-ethyl-4-methyl-6-hydroxy
pyrimidine was identified. This degradate was not identified in
the aerobic soil metabolism study. Although this study does not
satisfy Agency data requirements for an aged leaching study, it
can be upgraded with submission of data that fully characterizes
the second degradate.
HUMAN NONDIETARY EXPOSURE
Exposure estimates were made for turf and Chinese cabbage,
broccoli, and lettuce using available data and an adaptation of
the method suggested in the Pesticide Assessment Guidelines
subdivision K (Non-Detectable Residue Method). The exposure for a
10 kg child playing on turf treated with diazinon after the spray
has dried on day of application was calculated to be 0.000031
mg/kg/hr. This estimation was based on an application rate of
10.89 Ib/A, which is higher than the current label rate and
without the subsequent application of water to dissolve or
incorporate if granular. It is therefore a conservative
estimate of exposure.
Foliar dislodgeable residue data representing a worst case
for dissipation and exposure, citrus application with the most
retentive type of formulation (wettable powder) in an arid
region of California were reviewed. Estimated fieldworker
exposure values using the above criteria were 3.2 mg/hr on day 1;
0.57 mg/hr on day 2; and declined to 0.036 mg/hr by day 5. These
exposure values would be applicable for diazinon applications of
2.0 Ib ai/A or lower.
A reentry interval has been proposed but can not be accepted
until all applicable data have been reviewed. In order to estab-
lish a reentry interval, an Allowable Exposure Level (AEL) must
be estimated. Data submitted to establish a reentry interval
were used to calculate an AEL of 0.875 mg/hr. If the AEL is
accepted, the 24-hour reentry interval for all commercial
agricultural crop uses including greenhouses and the statement
allowing children to play on home lawns after spray has dried
would be acceptable.
21
-------
An interim reentry interval of 24-hours will be imposed for
commercial agricultural uses involving hand labor (see PR Notices
83-2 and 84-1 for a description of hand labor agricultural
practices) and commercial greenhouse uses.
Poisoning Incidents
During 1961, 1969, 1973, and 1974, when accidental
deaths due to pesticides in the U.S. were counted, diazinon
was found to be the sixth most frequent cause of death. Diazinon
averaged 2.5 deaths per year during the survey (Hayes,W.J. and
Vaughn, W.K., 1977). California, which kept count of all
accidental pesticide-related deaths, reported two diazinon
related fatalities during the time period 1965 through 1977.
One fatality was a child, the other was an adult poisoned in a
non-occupational case (CDFA 1965-1977).
A sampling of 12% of hospitals nationwide was conducted from
1974 to 1976 to estimate pesticide-related hospitalizations.
During this period, diazinon was estimated to have caused 88 hos-
pitalizations based on the sample. The survey ranked diazinon as
the sixth most frequent cause of pesticide poisonings. Twelve
percent of the diazinon hospitalizations were from occupational
exposure, 61% from non-occupational exposure and home use, 24%
from intentional ingestion, and 3% from unknown causes (USEPA,
1985).
A 1984 survey of hospital emergency room pesticide-related
cases indicated that diazinon accounted for 2% of the total. The
survey concluded that of that total, 88% of the poisonings
occurred in the home.
The Agency's Pesticide Incident Monitoring System (PIMS)
report for diazinon was reviewed to determine the circumstances
involved in diazinon poisonings. The poisonings were classified
as: 1) Intentional Ingestion; 2) Accidental Ingestion; 3)
Homeowner Misuse. The report concluded that poisonings from
agricultural uses were uncommon and that poisonings generally were
the result of improper use by the homeowner, for example, spraying
into the wind or failure to remove contaminated clothing.
In a national survey of household pesticides use conducted
in 1976 through 1977, diazinon was found to be the seventh most
common pesticide used in the home, occurring in 3.2% of all house-
holds surveyed.
The State of California, the only state that enforces
mandatory reporting of occupational pesticide incidents, reported
30 cases of illness or injury as a result of occupational exposure
during 1987; (5) applicator ground, (6) applicator, hand-held
equipment, (3) coincidental exposure, (1) emergency response
personnel, (3) exposure to concentrate, non-use exposure, (3)
22
-------
exposure to residues, agricultural field, and (9) exposure
to residues, non-agricultural (CDFA 1987).
No poisoning incident data are avialable for 1981 through
1985.
Non-Dietary Exposure Assessment
A review of the poisoning incident data demonstrates that
diazinon is a major source of pesticide-related poisonings in the
home. The number of incidences appear to partially reflect the
large quantities of diazinon used, particularly in the home. The
relatively low levels of agricultural occupational poisonings
suggest that current use practices do not lead to high numbers of
acute poisonings. Improvement of the labelling language should
help to lower the number of occupational poisonings that do occur.
The nature of the poisonings involving home uses demonstrate
that homeowners are not properly equipped to safely handle many of
the more concentrated formulations of diazinon, which have a
higher toxicity,
D. TOLERANCE REASSESSMENT
Tolerances have been established for residues of diazinon in
a variety of raw agricultural commodities, in meat, fat and meat
byproducts (40 CFR 180.153), food additives (40 CFR 185.1750),
food handling establishments (40 CFR 185.1750), and feed handling/
processing establishments (40 CFR 186.1750). Tolerances for
residues of diazinon are currently expressed as residues of
diazinon per se. EPA has evaluated the residue and toxicology
data supporting these tolerances. The following were considered
during this evaluation:
o Whether the current tolerances and food/feed additive
regulations are sufficient to cover the actual residues resulting
from use (including uses registered under FIFRA sec. 24(c).
o Whether group tolerances can be established in accordance
with 40 CFR 180.34(f).
o Whether, in the absence of tolerances, restrictions on use,
grazing, or feeding of treated commodities are necessary.
o Whether the tolerances are expressed accurately and in
current terminology.
The regulatory determinations resulting from EPA's review are
set out in Section IV.A., Regulatory Positions and Rationales.
23
-------
l. Residue Data.
a. Nature of the Residues in Plants and Animals:
The metabolism of diazinon in plants and animals is not
adequately understood. Preliminary data suggests that diazinon
in plants is oxidized to diazoxon (II)5 which is in turn
hydrolyzed to 2-isopropyl-4-methylpyrimidin-6-ol (III). The
existence of hydroxydiazinon (IV) in kale samples treated with
diazinon in the field could be caused by the effect of UV-
irradiation. Preliminary data has tentatively identified several
diazinon metabolites ( X and XI) in cow urine. Diazinon
metabolites (VII), (VIII), and (IX) have been identified in rat
urine.
b. Analytical Methodology:
Adequate sulfide, phosphorus, pyrimidine, cholinesterase
inhibition , GC, and GLC methods are available for collection of
data pertaining to residues of diazinon in or on plant commodi-
ties, with exception of the cholinesterase method or the
colorimetric methods which specify surface stripping rather than
grinding or homogenation of plant samples. A colorimetric sulfide
method is also adequate for the determination of diazinon in
animal commodities. The sulfide method (Method II(a) in PAM,
Volume II, Pesticide Regulation § 180.153) is subject to
interference from thiocarbamates and crops with high thiol content
( such as cabbage, kale, turnips, radish, collards, Brussels
sprouts, and mustard greens). Therefore, for regulatory purposes,
the Agency recommends Method II(c) in PAM, Vol. II which has an
additional column clean up step for crops with high thiol content.
Both diazinon and its metabolite, diazoxon, are determined by the
phosphorus method. The pyrimidine procedure detects diazinon and
the potential metabolites (see table 1).
The cholinesterase inhibition procedure is subject to natural
interference and will measure other thiophosphate insecticides if
present. Successful method trials of the sulfide method have been
completed on various commodities, but recoveries from beef fat
were relatively poor at fortification levels of 0.25-0.05 ppm.
The GC or GLC method can be used as a confirmatory or an
alternative method to determine the residues of diazinon and its
metabolites.
Diazinon is determined by multiresidue procedures published
in the Pesticide Analytical Manual Vol. I. No additional data
are required as per 40 CFR § 158.240(b)(15).
See table 1 for identification of diazinon metabolites.
24
-------
c. Storage Stability:
No data are available to determine the stability of diazinon
or its metabolites in plants under storage conditions.
All of the plant residue and animal feeding data requested in
this standard must be accompanied by information pertaining to the
conditions and duration of sample storage prior to residue
analysis and on the stability of diazinon under the storage
conditions used.
It should be noted that the nature of the residue in plants
and in animals has not been adequately described. If the
requested metabolism data indicate the presence of residues of
toxicological concern in plant and in animals commodities, data
depicting the stability of such residues in storage will be
required.
d. Magnitude of the Residues in Raw Agricultural
Commodities and food and feed items:
Available data are not adequate to support many of the
established tolerances for diazinon, excluding coffee beans, guar
beans and guar forage. Data on the magnitude and levels of
residues of diazinon and its metabolites in individual raw
agricultural commodities and food and feed items are required.
e. Magnitude of the Residue in Meat, Milk, Poultry,
and Eggs:
The adequacy of the established tolerances for meat, milk,
poultry and eggs cannot be determined at this time. The nature of
the residues in ruminants (including milk) and in poultry
(including eggs) is not adequately understood. Additional data
are required for raw agricultural commodities and processed
products comprising animal feeds.
f. Food Handling Establishments:
No numerical tolerances have been established covering
residues of diazinon in foods resulting from treatment of food
handling establishments. Data are required depicting residues of
concern in or on food resulting from applications of diazinon in a
food service, food manufacturing, or a food processing establish-
ment.
25
-------
Table 1. Diazlnon and Its metabolites 1n plants and animals.
CODE
STRUCTURE
CHEMICAL NAME
COMMON NAME Off
ABBREVIATION
0,0-diethyl 0-(2-isopropyl-
6-methyl-4-pyrimidinyl)
phosphorothioate
D1az1non
0,0-diethyl 0-(2-isopropyl-
6-methly-4-priraidinyl)
phosphate
Dlazoxon
CH,
OH
CH,
2-1sopropyl-4-methyl-
pyrim1din-6-ol
0.0-d1ethyl 0[2-(2'-
hydroxy-2'-propyl)-
4-methyl-6-pyrimidinyl]
phosphorothioate
Hydroxy-
diazinon
Vb
'OC,H.
H/v*'ln»
'~l*v
OC,H5
\
CH,OH
0,0-diethyl 0-[2-(l-methyl-
ethyl)-6-hydroxymethyl-4-
pyrimidlnyl] phosphorodi-
thioate
Vjb
CH.
CH,
0.0-d1ethyl 0-[2-(l-methyl-
vi nyl)-6-methyl-4-pyrldi nyl]
phosphorothioate
VIIC
2-(1-hydroxy-l-methyl ethyl)-
4-pyrimidinone
26
-------
Table 1. (Continued),
Vine _ 2-(l-methyl-2-hydroxyethyl).
4-pyrimidinone
IXC u 6-methyl-2-(1-methyl ethyl)-
4-pyrimidinone
Diethyl phosphorothiolc
acid
HO-
Diethyl phosphoric acid
O .r\f u
HO-f
Identified 1n plants.
^Identified in sheep tissues.
cldentified in rat urine.
^identified in cow urine.
27
-------
2. Tolerances issued.
Codex MRL's, Canadian, and Mexican tolerances have been
established for diazinon in a number of commodities.
Compatibility of these tolerances to that of U.S. tolerances
cannot be determined until all additional metabolism and residue
studies are available.
3. Toxicology Data.
Based on inhibition of plasma cholinesterase observed in a 90
day rat feeding study a NOEL of 0.009 mg/kg/day was established.
A provisional acceptable daily intake (PADI) has been established
at 0.00009 mg/kg/day utilizing an uncertainty factor of 100. The
PADI is provisional because the existing data base on diazinon
is lacking chronic feeding studies, and a multi-generation
reproduction study.
The Theoretical Maximum Residue Contribution (TMRC) adjusted
for percent of crop treated for the U.S. population average was
calculated at 0.000767 mg/kg/day corresponding to 852% of the
PADI. The TMRC is based upon current published tolerances and
adjusted for percent of crop treated. It should be noted that the
amount of pesticides used on crops that are grown on only a few
acres and the amount of less commonly used pesticides on more
important crops are difficult to determine; therefore it is likely
that usage has been overestimated and the actual percent crop
treated may be lower.
Moveover, the TMRC represents a worst case estimate of
exposure that assumes that all crops are treated at the maxi-
mum rate and minimum pre harvest interval. The use of the
TMRC also assumes that all commodities bear residues at the
maximum level and that are all persons consume these commodi-
ties. These assumptions lead to a conservative estimate of
dietary exposure.
The Agency is not able to calculate an Anticipated Residue
Contribution, which is a more realistic estimate of dietary
exposure, since no processing or anticipated residue data are
available. When the required data are submitted, the Agency
will conduct a full tolerance reassessment.
28
-------
References Cited
1. CDFA, California Department of Food and Agricultural (1987)
Summary Tables of Reports from Physicians of Possible
Illnesses Related to Pesticide Exposure During January 1-
December 31, 1987 in California. Unpublished report,
Worker Health and Safety Branch, CDFA, HS-1493.
2. CDFA, California Department of Food and Agricultural (1985)
Summary Tables of Reports from Physicians of Possible
Illnesses Related to Pesticide Exposure During 1965-1977
and 1981-1985 in California. Unpublished reports, Worker
Health and Safety Branch, CDFA, HS-322,HS-545, HS-1098,
HS-1186, HS-1188, HS-1304, HS-1305, HS-1370, and HS-1371.
3. Hayes, W.J. and Vaughn, W.K. (1977). Mortality from pesticides
in the United States in 1973 and 1974. Toxicology and Applied
Pharmacology 42:235-252.
4. USEPA (1985) Evaluation of Epidemiologic Factors from Two
National Studies of Hospitalized Pesticides Poisonings.
USEPA report (October 1985).
29
-------
IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data and other
relevant information on diazinon, the Agency has made the
following determinations:
1. Special review
The Agency is deferring a decision at this time on whether to
place diazinon into Special Review for its potential hazard to
non-target species resulting from its use on agricultural crops,
on turf and other grassy sites (eg., athletic fields, recreational
parks, home lawns).
Rationale; The Agency is assessing the magnitude of the
potential hazard to non-target species from the application of
diazinon formulations on agricultural crops and on grassy sites.
The available laboratory, field toxicity studies, residue and
exposure studies, and bird kill incidents are being closely
examined to determine whether or not a Special Review or other
types of regulatory actions are appropriate for this issue of
concern to the Agency. Upon completion of the examination, a
decision will be made.
2. Restricted Use [Commercial Outdoor Uses]
The Agency is classifying all commercial outdoor uses
(eg.,agricultural crops, ornamentals, and turf) of diazinon for
restricted use, based upon its known toxicity to birds and aquatic
species.
Rationale; Diazinon meets the criteria of 40 CFR 152.170
due to its high avian and aquatic toxicity. Without further
restrictions, the Agency concludes that current commercial
agricultural uses of diazinon may pose an adverse risk to birds
and aquatic invertebrates.
3. Restricted Use [Residential End-Use]
All diazinon end-use products that are in Toxicity Category I
or II (DANGER or WARNING) and bear product labeling that directly
recommends residential use or reasonably can be interpreted to
permit residential use are classified for restricted use. Such
products may be used only by certified applicators or persons
under their direct supervision. In the past, the Agency has
allowed these types of products to be labeled , "For
Agricultural Use Only" or "For PCO Use Only". However, these
statements are not enforceable.
30
-------
Rationale; Diazinon end use products in Toxicity Categories I
and II intended for residential/institutional use meet the
criteria for restricted use in 152.170; (i) incident information
(see Section III, Poisoning Incidents) show that a large number of
incidents involving diazinon (61% in one hospital survey) were
reported to have occurred from residential use, (ii) available
toxicity data places these end use products in toxicity categories
I and II for acute oral toxicity, (iii) current or revised
precautionary statements would not sufficiently minimize the risks
to homeowners, and (iv) the use of protective clothing generally
not expected to be available to the general public. Statements
purporting to limit application to commercial applicators or PCOs
are not enforceable. Classification for restricted use will
ensure that these products are used only by persons who have been
trained in proper application techniques to minimize hazardous
exposures.
4. Homeowner Precautionary Statements
The Agency is imposing additional protective clothing and use
instructions statement for all end-use products intended for use
in and around the home. Refer to section IV.D. which specifies
labeling language to be used.
Rationale; Due to the number of homeowner poisoning
incidents, the Agency believes that additional labeling statements
are warranted in order to provide additional use and safety
information to the homeowner.
5. Toxicity Testing with Typical End Use Products
The Agency will is requiring the following testing of a series
of typical end use products: acute oral, acute dermal, primary
dermal irritation, primary eye irritation, dermal sensitization,
and acute inhalation if appropriate. The Agency will reserve
alternative product formulations testing, pending submission and
review of toxicity testing on the stabilized technical diazinon
products (manufacturing use products).
Rat i onale: These tests are necessary to ensure that end use
product is properly labeled with respect to human and hazard
signal word and precautionary statements. Available data do not
adequately characterize the toxicity profile of diazinon end-use
products. The Agency will conduct a toxicological assessment of
the data submitted and determine whether additional regulatory
action is necessary.
31
-------
6. Bridging Toxicity Testing with Manufacturing Use Products
The Agency will require each registrant of a manufacturing use
product to submit the following toxicity studies on their current
formulations: acute oral, acute dermal, acute inhalation, primary
dermal irritation, primary eye irritation, dermal sensitization,
and a 6-week rat feeding study. The Agency may require additional
toxicity testing based upon its evaluation of these studies.
Rationale; The Agency is concerned with reported contami-
nation of technical diazinon with tetraethylpyrophosphate (TEPP)
sulfotepp, and monotepp, and other potentially highly potent
organophosphate cholinesterase inhibitors which may be formed
during the manufacturing process. Since manufacturing processes
are not the same for all technical products and different manu-
facturing processes may result in different levels of contamin-
ants, the Agency believes that different stabilized diazinon
technical products may have substantially different acute and/or
subacute toxicity characteristics. In order to evaluate the
toxicological similarities and/or dissimilarities of the
currently registered manufacturing use products the above listed
studies must be conducted.
7. Endangered Species
The U.S. Fish and Wildlife Service, Division of Endangered
Species and Habitat Conservation (DESCH) has determined that
certain uses of diazinon, including uses on corn and sorghum may
jeopardize the continued existence of endangered species. Based
on this determination, DESHC specified reasonable and prudent
alternatives to avoid jeopardizing the continued existence of the
identified species by these uses.
No additional labeling is being required at this time. As
explained below, labeling requirements issued in PR Notices
87-4 and 87-5 have been withdrawn pending re-issuance.
Rationale; Diazinon is very highly toxic to avian species,
both on a acute and dietary basis. The acute LD50 for birds is
less than or equal to 10 mg/kg for terrestrial, aquatic and
songbird species. The dietary LCSOs for avian species are in the
range of 47 - 245 ppm.
Diazinon is also highly toxic to fish: the fish LC50 for
technical diazinon ranges from 90 ug/L for rainbow trout to 1700
ug/L for cutthroat trout. The LC50 in freshwater invertebrates
is 1.4 ug/L or less.
Endangered species of avian and aquatic species may be at a
greater risk from use of diazinon than the species tested.
32
-------
In May 1987, EPA issued PR Notices 87-4 and 87-5 in response to
FWS findings that certain pesticides, including this chemical,
jeopardized the continued existence of endangered species. Those
PR Notices directed registrants to add labeling to their products
which referred users to additional information that, in turn,
explained limitations on use of the pesticide within the range of
jeopardized endangered species. Subsequent to issuance of these
PR Notices, EPA identified a number of significant technical
errors and inconsistencies in the information to which users
would have been referred. Therefore, on January 26, 1988 the
Agency issued PR Notice 88-1 which withdrew PR Notices 87-4 and
87-5 pending development of a more focused program to protect
endangered species.
EPA is working to correct these errors prior to requiring
labeling to protect endangered species. When that program is
fully developed, notice of any labeling necessary to protect
endangered species will be issued.
8. Reentry Interval
The Agency will impose an interim 24-hour reentry interval
for commercial greenhouse uses and commercial agricultural uses,
identified under PR Notices 83-7 and 84-1, of diazinon.
Rationale; Data to establish a definitive reentry interval
for diazinon have recently been submitted and are currently under
review. The 24-hour interim reentry interval is based upon the
AEL, 0.875 mg/hr, and the decline in worker exposure below the AEL
by day 2, 0.57 mg/hr.
9. Worker Safety and Protective Clothing
The Agency is revising worker safety and protective
equipment statements for end use products containing diazinon.
Section IV.D. specifies the wording for products in Toxicity
Categories I, II and III.
Rationale; Current protective clothing requirements for
diazinon are not adequate to minimize exposure to agricultural
workers. The Agency is concerned that exposure to diazinon
could present a health risk to agricultural workers due to the
high acute toxicity of certain end use formulations of this
pesticide.
33
-------
10. Groundwater Concerns
The Agency is not imposing a ground water contamination
advisory statement for diazinon products at this time.
The Agency will assess the potential of diazinon for
groundwater contamination after receipt and review of environ-
mental fate data and will determine whether regulatory action is
necessary.
Rationale: The Agency is unable to fully assess the potential
for diazinon to contaminate groundwater. Preliminary
data indicate that diazinon degrades rapidly under aerobic,
anaerobic, aquatic anaerobic, and sterile soil conditions.
However, diazinon's major soil degradate, oxypyrimidine, is more
persistent than diazinon under similar soil conditions.
11. Non-Target Species Labeling
In order to meet the statutory standard for continued
registration, the Agency has determined that diazinon products
must bear revised and updated labeling for hazards to nontarget
species.
Rationale; Labeling statements are required since available
data show that diazinon is extremely toxic to birds, non-target
insects, and aquatic organisms.
12. Tolerance Revocation
The Agency will propose tolerance revocation for rutabagas,
red chicory tops, and dandelions (40 CFR 180.153).
Rationale; Currently there are no registered products bearing
these uses.
13. Tolerance Proposals
Residue data must be submitted and tolerances must be proposed
for corn fodder and forage, and either sorghum forage and fodder,
or wheat forage, hay and straw, and soybean straw and hay.
Rationale; Currently there are no established tolerances to
cover residues of diazinon on these commodities. Residue data
are not available to determine appropriate tolerance levels for
expected residues in or on these commodities.
34
-------
14. Grazing and Feeding Restrictions
For the following crops; sorghum fodder and forage, soybean
straw and hay, and sugarcane forage, the registrant is given the
choice of developing and submitting data in support of tolerances,
or of adding label restrictions against the feeding and grazing of
treated crops to livestock. Each registrant must inform the Agency
by 90 days of receipt of this Registration Standard which option
he chooses. If he selects the label restrictions, labeling
submitted at the 9 month deadline must include the grazing/feeding
restrictions.
Rationale; These raw agricultural commodities are used as feed
and forage for livestock and tolerances are required.
15. Tolerances and New Uses6
The Agency will not grant any significant tolerances or any
significant food uses for diazinon until the required residue
chemistry and toxicology studies have been submitted and reviewed.
Rationale: The Agency needs additional residue, plant, and
animal metabolism data in order to characterize the nature of
of residues in plants and animals. In addition storage stability
data are required before a tolerance reassessment for diazinon can
be performed.
16. Established Tolerances
The Agency is not requiring additional residue data to support
the established tolerances for diazinon in or on
guar beans and coffee beans.
Rationale; Sufficient residue data are available to determine
the adequacy of the established tolerances for diazinon in or on
these commodities (40 CFR 180.153).
New Uses is defined in 40 CFR 152.3 (p).ln the case
of a new food or use, the Agency will generally consider
as significant an increase in the Theoretical Maximum
Residue Contribution (TMRC) of greater than 1%.
35
-------
17. Commodity Definitions
The Agency will revise commodity definitions for certain raw
agricultural commodities listed in 40 CFR 180.153.
a) Tolerance listing "peas with pods (determined on peas
after removing any shell present when marketed)" will be
revised to read, "peas, succulent".
b) Tolerance listing "bean forage" will be revised to read,
"bean vines".
c) the tolerance listing for "wheat forage and straw" was
omitted from listing and will read "wheat forage and straw
0.05 ppm".
Rationale; These listings in 40 CFR 180.153 are not accurate,
or do not use current terminology.
18.
Uses not Supported
The Agency is aware that the following crop uses will not be
supported by the principal end use product registrant. If these
uses are not supported by other technical producers, end use
registrants will be required to provide appropriate data, delete
the uses from their labels, or face suspension of their products,
Fruits and Nuts;
grapefruit
oranges
kumquats
blueberries
olives
lemons
tangelos
citrus citron
coffee
filberts
limes,
tangerines,
hybrids of citrus fruits,
figs,
pecans.
Vegetables, Foliar and/ or Preplant
beans (dried varieties),
beans, pinto
watercress.
Field & Forage Crops
alfalfa clover
cotton cowpeas
peanuts sorghum
sugarcane tobacco,
corn, field
Range, Pasture, & Grassland
Burmudagrass rangeland
grass forage.
peas (dried varieties),
mushrooms,
trefoil,
lespedeza,
soybeans,
pasture,
36
-------
Rationale: The Agency believes its prudent to provide
end use formulators with current information that may have
a significant effect on their registrations and to provide
an efficient means to disseminate this information to the
end use formulator.
19. Establishment of Common Name
The common name "diazinon" will appear before the chemical
name on the pesticide label. Labels must be revised to reflect
this. Refer to section IV.D.
Rationale; The common name "diazinon" has been accepted by
the American National Standards Institute, Inc. (ANSI). The
Agency uses common names to encourage familiarity with pesticide
names.
20. Inert Ingredients
Petroleum distillates and xylene based solvents appearing on
the product label as actives must be declared as inert ingre-
dients or the registrant must provide information substantiating
its active classification. In addition, all products containing
more than 10% of either solvent must identify the petroleum
distillate or xylene by name as a substatement to the ingredient
statement.
Rationale; Petroleum distillates and xylene based solvents
contained in diazinon end use formulations have not been
identified as causing a pesticidal effect and are not considered
as active ingredients.
21. Studies that will receive Immediate Review.
The Agency has identified certain data that will receive
immediate review when submitted.
Rationale; Certain of the data being required by the Agency
are essential to resolve risk concerns, or may trigger the need
for further studies which should be initiated as soon as possible.
The following studies have been identified to receive priority
review as soon as they are received by the Agency:
158.240 Residue Chemistry
- Plant and Animal Metabolism
- Special Storage Stability (EUP)
158.290 Environmental Fate
- Hydrolysis
- Photolysis
37
-------
158.340 Toxicology
- Acute Toxicity Studies (MUP)
- 6-week oral feeding study (MUP)
- Acute delayed neurotoxicity
- Acute Toxicity Studies (TEP)
158.490 Ecological Effects
22. Continuation of registration
While data gaps are being filled, currently registered
manufacturing use products (MPs) and end use products (EPs)
containing diazinon may be sold, distributed, formulated and used,
subject to the terms and conditions specified in this Standard.
Registrants must provide or agree to develop additional data, as
specified in the Data Appendices, in order to maintain existing
registrations.
Rationale; Under FIFRA, the Agency does not normally cancel
or withhold registration simply because data are missing or are
inadequate (see FIFRA sec. 3(c)(2)(B) and 3(c)(7).
Issuance of this Standard provides a mechanism for
identifying data needs and labeling changes arising from available
data. Required data will be reviewed and evaluated, after which
the Agency will determine if additional regulatory actions are
necessary.
38
-------
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain diazinon, bear required labeling, and
conform to the product composition, acute toxicity limits, and use
pattern requirements listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain this pesticide.
Each MP formulation proposed for registration must be fully
described with an appropriate certification of limits, stating
maximum and minimum amounts of the active ingredient and inert
ingredients which are present in products, as well as impurities
found at greater than 0.1 percent, except for those impurities of
toxicological importance (TEPP and its sulfur derivatives and oxo-
diazinon) for which upper certified limits of less than 0.1% may
be indicated.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade and
manufacturing-use products containing this pesticide provided that
the product labeling bears appropriate precautionary statements
for the acute toxicity category in which each product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products only
for the commodities listed in the EPA Compendium of Acceptable
Uses (for availability, see page 1). The Compendium lists all
registered uses, as well as approved maximum application rates and
frequencies.
D. LABELING
In order to remain in compliance with FIFRA, products must
bear appropriate labeling as specified in 40 CFR 156.10 and this
Standard, or must be revised to conform to those specifications.
Appendix II contains information on label requirements.
No pesticide product containing this pesticide may be
released for shipment by the registrant after March 31, 1990,
unless the product bears an amended label which complies with the
requirements of this Standard.
39
-------
No pesticide product containing this pesticide may be
distributed or sold after March 31, 1991, unless the product
bears an amended label which complies with the requirements of
this Standard.
The following specific information must appear on the
labeling in order for products to remain in compliance with FIFRA:
1. Ingredients Statement
The ingredient statement for products must list the active
ingredient as:
ACTIVE INGREDIENT
Diazinon [0,0-Diethyl O-(2-isopropyl-6-methyl-
4-pyrimidinyl) phosphorothioate] %
All products containing petroleum distillates, xylene, or
xylene range solvent must identify these in a substatement to the
ingredients statement. The following statement is acceptable for
this purpose: "Contains [petroleum distillate, xylene, xylene
range solvent]," as appropriate.
2. Use Pattern Statements
All manufacturing-use products must state that they are
intended for formulation into end-use products for acceptable use
patterns. Labeling must specify sites, which are listed in the
EPA Compendium of Acceptable Uses (for availability see page 1).
However, no use may be included on the label where the registrant
fails to agree to comply with the data requirements in TABLE A for
that use pattern.
3. Precautionary Statements
STATEMENTS FOR MANUFACTURING-USE PRODUCTS
Environmental Hazards Statement;
"This pesticide is highly toxic to fish and wildlife. Do not
discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans, or public waters unless
this product is specifically identified and addressed in an
NPDES permit. Do not discharge effluent containing this
product to sewer systems without previously notifying the
sewage treatment plant authority. For guidance, contact your
State Water Board or Regional Office of the Environmental
Protection Agency."
40
-------
STATEMENTS FOR END-USE PRODUCTS
1. Restricted use Statement
a. The following statement must appear on the front panel of
all products for commercial outdoor use.
RESTRICTED USE PESTICIDE
| Due to Avian and Aquatic Toxicity
I
| For retail sale to and use only by Certified Applicators
I or persons under their direct supervision and only for
I those uses covered by the Certified Applicator's
j Certification
b. The following statement must appear on the front panel of
all products intended for residential use by homeowners in
Toxicity Category I or II (Danger or Warning).
RESTRICTED USE PESTICIDE
Due to Acute Toxicity
I
For retail sale to and use only by Certified Applicator or |
persons under their direct supervision and only for those |
uses covered by the Certified Applicators's Certification j
2. Dermal Sensitization Statement;
The following statement must appear in the Precautionary Statement
Section.
"May cause contact sensitization following repeated contact
following repeated contact with skin in susceptible
individuals. Avoid repeated contact with skin. If sensiti-
zation reactions results consult a physician".
3. Environmental Hazards Statement;
The following statement must appear on non-granular formulations.
"This pesticide is highly toxic to birds, fish, and wildlife
including waterfowl. Birds and waterfowl feeding or drinking
on treated areas may be killed. Because of the migratory
habits of certain Atlantic Coast waterfowl, do not apply this
41
-------
product in Nassau County, New York between November 1 and
May 20. Do not exceed maximum permitted label rates above
those recommended significantly increase potential hazards
to birds and waterfowl. Avoid overlapping of sprays. Where
irrigation (watering) is recommended apply a minimum of 0.25
inch of water immediately after application. Stop irrigation
before pudding occurs. Keep out of lakes, streams, ponds,
tidal marshes and estuaries (except for effluence from
treated watercress beds). Do not apply to water that will
be used for recreational purpose and human and livestock
consumption. Shrimp and crab may be killed at applications
rates recommended on this label. Do not apply where fish,
shrimp, crab, and other aquatic life are important resources.
The following statement must appear on all granular
formulations applied by ground equipment.
"This pesticide is highly toxic to fish and wildlife. Birds
feeding in treated areas may be killed. Do not apply
directly to water or wetlands (swamps, bogs, marshes, and
pot-holes). Runoff maybe hazardous to aquatic organisms in
neighboring areas. Collect or incorporate granules that
are spilled during loading or are visible on soil surface in
turn areas. Do not contaminate water when disposing of
equipment washwaters".
The following statement must appear on all granular
formulations applied by aerial applications.
"This pesticide is highly toxic to fish and wildlife. Birds
feeding in treated areas may be killed. Do not apply
directly to water or wetlands (swamps, bogs, marshes, and
pot-holes). Drift and runoff maybe hazardous to aquatic
organisms in neighboring areas. Collect granules that are
spilled during loading ".
4. Bee Caution Statements;
The following statement must appear on all products
intended for outdoor use (excluding granular formulations).
" This pesticide is highly toxic to bees exposed to direct
treatment or 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."
An additional auxiliary environmental statement should be
placed in the use directions as appropriate.
42
-------
Foliar application to alfalfa, peas, or beans: "Do not
apply if the crop or weeds in the treatment area are
in bloom."
Foliar application to corn: "Do not apply to corn during
the pollen shed period."
Foliar application to fruit trees (apple, cherry, peach,
plum, and citrus): "Do not apply when trees or substantial
numbers of weeds in the orchard (grove) are in bloom."
5. Homeowner Protection Statements;
The following statements must appear on all liquid products
intended for, or packaged for use in or around the home, excluding
pet collars, insect tapes, and dust formulations.
"Indoor Domestic Use: Do not spray in the immediate area
when others are present. After application open windows
and/or doors to provide adequate fresh air ventilation to
the room(s). Remove clothing after spraying and launder
before reuse."
"Outdoor Domestic Use: Wear a long sleeve shirt and long
legged pants. Spray with the wind to your back. Do not
spray on windy days (wind speed is greater than 10 miles
per hour). Remove clothing after spraying and launder
before reuse. If clothing becomes wet from spray, stop
spraying, immediately remove clothes and shower with
soap and water."
"Do not allow children or pets onto a treated area until the
spray has dried." or "Do not allow children or pets on
treated area until granules have been watered into
soil and grass has dried."
43
-------
6. Non-Domestic Protection Statements;
For those products registered for use in hospitals and/or
nursing homes the following statement must appear in the precau-
tionary statement section.
" Do not apply this pesticide in patient rooms or in any room
occupied by the infirm, elderly, or children for extended
periods of time."
For those products registered for use in schools the
following statement must appear in the precautionary statement
section.
" Do not apply this pesticide when class rooms are in use."
For those products registered for commercial use in
institutions (including but limited to office buildings, museums,
libraries, sports facilities, etc.) the following statement must
appear in the precautionary statement section.
" Do not apply this pesticide in the immediate area when
occupants are present."
44
-------
7. Food and Feed Handling Establishments
a. For those products registered for Crack and Crevice and Spot
Treatments in the food/feed areas of restaurants or other areas
where food/feed is commercial prepared or processed, the
following statements must appear in the Direction for Use section.
Feed and Food Handling Establishments Crack and Crevice and
Spot Treatments- Places other than private residences, in
which food is held, processed, prepared and/or served.
FOOD AND FEED ESTABLISHMENTS- Apply [your product name] as
either a spot or crack and crevice treatment as directed
below.
Food/Feed Areas- Includes receiving, serving, storage (Dry,
Cold Frozen, Raw), packaging (cleaning, slicing, cooking,
grinding), edible waste storage, enclosed processing systems
(mills, dairies, edible oils, syrups).
SPOT TREATMENT-FOOD/FEED AREAS- Limit spot treatments to
floor surfaces when pests have been seen or where they are
suspected of hiding. Limit individual spot treatments in
food/feed areas to an area no larger than 20 percent of the
floor. Any individual spot treatment shall not exceed 2 sq.
feet. Do not apply to areas, surfaces, or utensils which
will come in contact with food. Take extreme care to avoid
contamination of food or food contact surfaces or introducing
the material into the air.
CRACK AND CREVICE TREATMENT- Apply [your product name] spray
in small amounts directly into cracks and crevices using
equipment capable of delivering a pin stream of insecticide.
Includes expansion joints, spaces between equipment and
floors, and openings leading to voids and hollow spaces in
walls, equipment legs and bases. Do not use this product
in conduits, motor housings, and electrical switch boxes.
APPLICATION OF THIS PRODUCT IN THE FOOD/FEED AREAS OF FOOD/
FEED HANDLING ESTABLISHMENTS, OTHER THAN AS A CRACK AND
CREVICE [AND SPOT] TREATMENT ARE NOT PERMITTED.
NON-FOOD AREAS- Includes garbage rooms, lavatories, floor
drains (to sewers), entries and vestibules, offices,
locker rooms, machine rooms, boiler rooms, mop closets and
storage (after canning or bottling).
NON-FOOD AREAS- SPOT TREATMENT- As a spot treatment apply
[your product name] as a coarse low pressure fan spray to
floor surface areas around water pipes, beneath cabinets,
refrigerators, sinks, stoves, storage areas, and similar
areas where cockroaches, ants, spiders, and silverfish hide.
45
-------
b. NON FOOD/FEED AREAS OF FOOD/FEED HANDLING ESTABLISHMENTS
For those products registered in the non-food/feed areas
of food/feed handling establishments, restaurants or other areas
where food/feed is commercially prepared or processed, the
following statements must appear in the Direction for Use section.
Do not use in food areas of food handling establishments,
restaurants or other areas where food/feed is commercially
prepared or processed. Do not use in serving areas while
food is exposed or facility is in operation. Serving areas
where prepared foods are served such as dining rooms but
excluding areas where foods may be prepared or held. In the
home, all food processing surfaces and utensils should be
covered during treatment or thoroughly washed before use.
Exposed food should be covered or removed.
NON-FOOD AREAS- Includes garbage rooms, lavatories, floor
drains (to sewers), entries and vestibules, offices,
locker rooms, machine rooms, boiler rooms, mop closets and
storage (after canning or bottling).
NON-FOOD AREAS- SPOT TREATMENT- As a spot treatment apply
[your product name] as a coarse low pressure fan spray to
floor surface areas around water pipes, beneath cabinets,
refrigerators, sinks, stoves, storage areas, and similar
areas where cockroaches, ants, spiders, and silverfish hide.
C. USE IN MEAT AND POULTRY PLANTS
Use in food-handling establishments can imply use in U.S.
Department of Agricultural (USDA) Meat and Poultry Plants.
Therefore, either add the statement, "Not for Use in USDA
MEAT AND POULTRY PLANTS" or submit an application to USDA
requesting use in these areas. If granted, you can then
indicate on the label, "For Use in USDA MEAT AND POULTRY
PLANTS".
46
-------
8. Worker Protection Statements
Updated Worker Protection Statements for TOXICITY I and II END-USE
FORMULATIONS OF DIAZINON.
WORK SAFETY RULES
REPEATED EXPOSURES TO CHOLINESTERASE INHIBITORS SUCH AS ARE
CONTAINED IN THIS PRODUCT MAY, WITHOUT WARNING, CAUSE PROLONGED
SUSCEPTIBILITY TO VERY SMALL DOSES OF ANY CHOLINESTERASE
INHIBITOR.
If handled indoors provide mechanical exhaust ventilation.
Keep all unprotected persons, children, livestock, and pets
away from treated areas or where there is a danger of drift.
Do not rub eyes or mouth with hands. If you feel sick in any way
STOP work and get help right away, See Practical Treatment
Section.
PERSONAL PROTECTIVE EQUIPMENT
WEAR THE FOLLOWING PROTECTIVE CLOTHING AND EQUIPMENT WHEN HANDLING
THE CONCENTRATE: A protective suit of one or two pieces that
covers all parts of the body except the head, hands, and feet;
chemical resistant gloves, chemical resistant apron, chemical
resistant shoes, shoe coverings, or boots, and socks.
[Liquid Formulations Only]. If handling the concentrate with a
closed system, a long-sleeved shirt and long-legged pants may be
substituted for the protective suit; shoes and socks.
WEAR THE FOLLOWING PROTECTIVE CLOTHING DURING APPLICATION,
EQUIPMENT CLEANING AND REPAIR, DISPOSAL OF SPRAY SOLUTION, AND
DURING REENTRY TO TREATED AREAS PRIOR TO THE SPRAYS HAVING DRIED
(OR DUSTS HAVING SETTLED): A protective suit of one or two pieces
that covers all parts of the body except the head, hands, and
feet; chemical resistant gloves, chemical resistant shoes, shoe
coverings, or boots, and socks.
IF APPLICATION IS PERFORMED USING AN ENCLOSED CAB OR COCKPIT, THE
FOLLOWING PROTECTIVE CLOTHING MAY BE WORN AS AN ALTERNATIVE: A
long-sleeved shirt, long-legged pants, shoes and socks. Chemical
resistant gloves must be available in the cab or cockpit and must
be worn when exiting. This clothing is inadequate to protect you
during equipment repair, cleaning, reentry, or pesticide disposal
work.
IMPORTANT! Before removing gloves, wash them with soap and water.
Always wash hands, face, and arms before smoking, eating,
drinking, or using the toilet.
47
-------
AFTER WORK ACTIVITIES: Before removing gloves, wash them with soap
and water. Take off all work clothes and shoes. Shower using
soap and water. Wear clean clothes. Do not reuse contaminated
clothing. Personal clothing worn during work must be laundered
separately from house hold articles. Store protective clothing
separately form personal clothing after each use. Clothing and
personal equipment heavily contaminated or drenched with diazinon
must be destroyed according to state and local regulations.
HEAVILY CONTAMINATED CLOTHING CANNOT BE ADEQUATELY
DECONTAMINATED. DURING AERIAL APPLICATION, HUMAN FLAGGERS MUST BE
IN TOTALLY ENCLOSED VEHICLES.
Updated Worker Protection Statements for TOXICITY III END-USE
FORMULATIONS of Diazinon.
WORK SAFETY RULES
REPEATED EXPOSURES TO CHOLINESTERASE INHIBITORS SUCH AS ARE
CONTAINED IN THIS PRODUCT MAY, WITHOUT WARNING, CAUSE PROLONGED
SUSCEPTIBILITY TO VERY SMALL DOSES OF ANY CHOLINESTERASE
INHIBITOR.
If handled indoors provide mechanical exhaust ventilation.
Keep all unprotected persons, children, livestock, and pets
away from treated areas or where there is a danger of drift.
Do not rub eyes or mouth with hands. If you feel sick in any way
STOP work and get help right away, See Practical Treatment
Section.
PERSONAL PROTECTIVE EQUIPMENT
Wear the following protective clothing when handling the
concentrate. Long-sleeved shirt and long-legged pants,
shoes and socks.
WEAR THE FOLLOWING PROTECTIVE CLOTHING DURING APPLICATION,
EQUIPMENT REPAIR AND CLEANING, DISPOSAL OF THE SPRAY SOLUTIONS:
Long-sleeved shirt and long-legged pants, shoes and socks.
FOR EARLY REENTRY (BEFORE THE 24-HOUR REENTRY INTERVAL HAS
EXPIRED) A protective suit of one or two pieces that covers all
parts of the body except the head, hands, and feet; chemical
resistant gloves, chemical resistant shoes, shoe coverings or
boots.
IMPORTANT! Before removing gloves, wash them with soap and water.
Always wash hands, face, and arms with soap and water before
smoking, eating, drinking, or using the toilet.
48
-------
AFTER USING THIS PRODUCT: Wash hands, face, and arms with soap
and water. Remove clothing that has become damp, wet, (or dusty)
while using this product and wash them separately from household
clothing. Clothing or gloves that have been heavily contaminated
or drenched with diazinon must be destroyed according to state and
local regulations. HEAVILY CONTAMINATED OR DRENCHED CLOTHING
CANNOT BE ADEQUATELY DECONTAMINATED.
DURING AERIAL APPLICATION, HUMAN FLAGGERS MUST BE IN TOTALLY
ENCLOSED VEHICLES.
9. Reentry Statements:
REENTRY
24-Hours for greenhouse and agricultural crops involving hand
labor (PR Notices 83-7 and 84-1).
For Commercial/Industrial products registered for use on
potatoes the following statement must appear in the Use Direction
for that crop.
"Note: Do not apply to commercially grown potatoes which will be
hand-harvested."
"Do not enter or allow entry into the treated area until the 24
hour reentry interval has expired, unless the person entering the
area is wearing the personal protective equipment listed on the
label".
"Do not apply this product in a way that will contact unprotected
workers, either directly or through drift. Only protected handlers
may be in the area during application".
49
-------
V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submittal or changes in composition, labeling or
packaging of the product. The applicable requirements depend on
whether the product is a manufacturing or end use product and
whether the pesticide is the sole active ingredient or one of
multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B^
3. The labeling requirements specified for
manufacturing use products in Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation
provisions) associated with reregistration.
B. Manufacturing use products containing this pesticide as one
of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
^Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to Tables in
that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registration
Standard. Table B lists product-Specific data applicable to
manufacturing-use products. The data in Tables A and B need not
be submitted by an end-use producer who is eligible for the
generic data exemption for that active ingredient.
Table C lists product-specific data applicable to end-use
products. The Agency has decided that, in most cases, it will
not require the submittal of product-specific data for end-use
products at this time. Therefore, most Registration Standards do
not contain a Table C.
50
-------
C. End use products containing this pesticide as the sole active
ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to
the end use product.
2. If eligible for the generic data exemption8, the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data
requirements listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of multiple
active ingredients are subject to:
1. If not eligible for the generic data exemption, the
data requirements listed in Tables A and C.
2. If eligible for the generic data exemption, the data
requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
8If you purchase from another producer and use as the source
of your active ingredient only EPA-registered products, you are
eligible for the generic data exemption for generic data
concerning that active ingredient (Table A) and product-specific
data for the registered manufacturing use product you purchase
(Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient, or
acquire your active ingredient from a firm with ownership in
common with yours, you individually lose the exemption and become
subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end-use
producers lose the exemption, and become subject to the data
requirements in Table A.
51
-------
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice issued
under the authority of FIFRA sec. 3(c)(2)(B). It refers to the
data listed in Table A, which are required to be submitted by
registrants to maintain in effect the registration of products
containing this active ingredient.9
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation" of a
product. "Typical formulation" testing is often required for
ecological effects studies and applies to all products having that
formulation type. These are classed as generic data, and are
contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's exemption
(FIFRA sec. 3(c)(2)(D) and 40 CFR 152.85) to submit generic data
in response to a DCI notice if the registrant who supplies the
active ingredient in his product is complying with the data
request.
If you are granted a generic data exemption, you rely on the
efforts of other persons to provide the Agency with the required
data. If the registrants who have committed to generate and
submit the required data fail to take appropriate steps to meet
the requirements or are no longer in compliance with this data
requirements notice, the Agency will consider that both they and
you are not in compliance and will normally initiate proceedings
to suspend the registrations of both your product(s) and their
product(s) unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed in
this Registration Standard.
52
-------
If you are not now eligible for a generic data exemption,
you may qualify for one if you change your source of supply to a
registered source that does not share ownership in common with
your firm. If you choose to change sources of supply, the
Confidential Statement of Formula must identify the new source(s)
and you must submit a Generic Data Exemption Statement.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic data
relevant to the uses of your product if, at the time the
application is submitted, the data have been submitted to the
Agency by current registrants. If the required data have not yet
been submitted, any new registration will be conditioned upon the
new registrant's submittal or citation of the required data not
later than the date upon which current registrants of similar
products are required to provide such data. See FIFRA sec.
3(c)(7)(A). If you thereafter fail to comply with the condition
of that registration to provide data, the registration may be
cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed to
evaluate current uses of all products containing this active
ingredient, the uses for which such data are required, and the
dates by which the data must be submitted to the Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form you
must state which of the following six methods you will use to
comply with the DCI requirements:
l. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will submit
the data on which you will rely. You must also provide EPA with
documentary evidence that an agreement has been formed which
allows you to rely upon the data to be submitted. Such evidence
may be: (1) your letter offering to join in an agreement and the
other registrant's acceptance of your offer, (2) a written
statement by the parties that an agreement exists, or (3) a
written statement by the person
53
-------
who will be submitting the data that you may rely upon its
submittal. The Agency will also require adequate assurance that
the person whom you state will provide the data is taking
appropriate steps to secure it. The agreement to produce the
data need not specify all of the terms of the final arrangement
between the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data Submitter
Number, as part of your 90-day response. The request must include
the following information:
a. A list of the members of the consortium;
b. The name and address of the designated
representative of the consortium, with whom EPA
will correspond concerning the data;
c. Identity of the Registration Standard containing the
data requirement;
d. A list of the products affected (from all members of
the consortium); and
e. Identification of the specific data that the
consortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.
3. You have attempted to enter into an agreement to jointly
develop data, but no other registrant has accepted your offer.
You request that EPA not suspend your registration for non-
compliance with the PCI. EPA has determined that, as a general
policy, it will not suspend the registration of a product when the
registrant has in good faith sought and continues to seek to enter
into a data development/cost sharing program, but the other
registrants developing the data have refused to accept its offer.
[If your offer is accepted, you may qualify for Option 2 above by
entering into an agreement to supply the data.]
In order to qualify for this method, you must:
a. File with EPA a completed "Certification of Attempt to
Enter into an Agreement with other Registrants for Develop-ment
of Data" (EPA Form 8580-6, enclosed).
b. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must, at a
minimum, contain the following language or its equivalent:
54
-------
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA
sec.3(c)(2)(B) in the [name of active ingredient]
Registration Standard upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided
by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to limit
this commitment. If the other registrant to whom your offer is
made does not accept your offer, and if the other registrant
informs us on a DCI Summary Sheet that he will develop and submit
the data required under the DCI, then you may qualify for this
option. In order for you to avoid suspension under this method,
you may not later withdraw or limit your offer to share in the
burden of developing the data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the
data.
4. You request a waiver of the data requirement. If you
believe that a data requirement does not (or should not) apply to
your product or its uses, you must provide EPA with a statement of
the reasons why you believe this is so. Your statement must
address the specific composition or use factors that lead you to
believe that a requirement does not apply. Since the Agency has
carefully considered the composition and uses of pesticide
products in determining that a data require-ment applies, EPA does
not anticipate that many waivers will be granted. A request for
waiver does not extend the time-frames for developing required
data, and if your waiver request is denied, your registration may
be suspended if you fail to submit the data. The Agency will
respond in writing to your request for a waiver.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required to
submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
55
-------
E. Registrant Requests Regarding Data Requirements and
Agency Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing. The
original requirement remains in effect unless the Agency has
notified you in writing that it has agreed to a change in the
requirement. While being considered by the Agency, such requests
for changes in the requirements do not alter the original
requirements or extend the time allowed for meeting the
requirement.
F. Test Protocols and Standards
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing. All testing must be
conducted in accordance with applicable Good Laboratory Practices
regulations in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are referenced in
the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD-recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (Part 158.70). Please note,
however, that certain OECD standards (such as test duration,
selection of test species, and degradate identification which are
environmental fate requirements) are less restrictive than those
in the EPA Assessment Guidelines listed above. When using the
OECD protocols, they should be modified as appropriate so that
the data generated by the study will satisfy the requirements of
Part 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not
conducted in accord with acceptable standards. The OECD protocols
are available from OECD, 1750 Pennsylvania Avenue, N.W.,
Washington, D.C. 20006.
G. Procedures for requesting a change in test protocol.
If you will generate the required data and plan to use test
procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
56
-------
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submittal of the data,
nor will extensions generally be given to conduct studies due to
submittal of inappropriate protocols. The Agency will respond in
writing to your request for protocol approval or change.
H. Procedures for requesting extensions of time.
If you think that you will need more time to generate the
data than is allowed by EPA's schedule, you may submit a request
for an extension of time.
EPA will view failure to request an extension before the
data submittal response deadline as a waiver of any future claim
that there was insufficient time to submit the data. While EPA
considers your request, you must strive to meet the deadline for
submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you have
taken to meet the testing deadline. Time extensions normally
will not be granted due to problems with laboratory capacity or
adequacy of funding, since the Agency believes that with proper
planning these can be overcome. The Agency will respond in
writing to any requests for extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data, including
the manner of reporting, the completeness of results, and the
adequacy of any required supporting (or raw) data, including, but
not limited to, requirements referenced or included in this Notice
or contained in PR Notice 86-5 (issued July 29, 1986). All
studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submittal
requirement.
J. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under FIFRA
sec. 3(c)(2)(B), an existing stocks provision for the registrant
is not consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances. If you
believe that your product will be suspended or cancelled and that
an existing stocks provision should be granted, you have the
burden of clearly demonstrating to EPA that granting such
permission would be consistent with the Act. The following
57
-------
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale
or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing using
a specific formulated product, and, unlike generic data,
generally support only the registration of that product. All such
data must be submitted by the dates specified in this
Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data are
listed in Table C. As noted earlier, the Agency has decided that
it will not routinely require product-specific data for end use
products at this time. Therefore, Table C may not be contained
in this Registration Standard; if there is no Table C, you are
not required to submit the data at this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D through J. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data) or
VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
58
-------
VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product and
its uses. General labeling requirements are set out in 40 CFR
156.10 (see Appendix II - LABELING and SUMMARY). In addition,
labeling language specific to products containing this pesticide
is specified in Section IV.D of this Registration Standard.
Responses to this Registration Standard must include draft
labeling for Agency review.
Labeling must be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage in 8-1/2 x
11 files. Draft labeling must indicate the intended colors of the
final label, clear indication of the front panel of the label, and
the intended type sizes of the text.
If you fail to submit revised labeling as required, which
complies with 40 CFR 156.10 and the specific instructions in
Section IV.D., EPA may seek to cancel the registration of your
product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration Standard
must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, B.C. 20460
Attn: Diazinon Registration Standard
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you must
submit for each product subject to this Registration Standard:
a. Generic Bata Exemption Statement (EPA Form 8580-3),
if applicable, or the "FIFRA Section 3(c)(2)(B) Summary
Sheet" (EPA Form 8580-1), with appropriate attachments.
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
59
-------
2. within 9 months from receipt of this document you must
submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed
course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you must
submit:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA sec. 3(c)(2)(B) Summary Sheet, with
appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
2. Within 9 months of receipt of this document, you must
submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you must
submit all generic data, unless you are eligible for the generic
data exemption. If for any reason any test is delayed or aborted
so that the schedule cannot be met, immediately notify the Agency
of the problem, the reasons for the problem, and your proposed
course of action.
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you must
submit:
60
-------
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from receipt of this document you must
submit:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
3. Within the times set forth in Table A, you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed
course of action.
D. End Use Products containing the subject active ingredient
as one of multiple active ingredients
1. Within 90 days from receipt of this document, you must
submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA Form
8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from the receipt of this document, you
must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the times set forth in Table Af you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed
course of action.
61
-------
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application for registration was submitted by
that date, no product may be released for shipment by the
producer after July 31, 1988.
62
-------
I. DATA APPENDICES
63
-------
TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements for
the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the test
protocols set out in the Pesticide Assessment Guidelines, which
are available from the National Technical Information Service,
5285 Prot Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the
composition of the test substance required to be used for the
test, as follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure Active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
64
-------
TGUIDE-2
F - Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I - Indoor
Any other designations will be defined in a footnote to the
table.
4. Does EPA have data? (Column 4). This column indicates one of
three answers:
YES - EPA has data in its files that completely satisfy
this data requirement. These data may be cited by other
registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species
or may possess data on one test substance but not all.
The term may also indicate that the data available to EPA
are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to the
table will usually say so.
NO - EPA either possesses no data which are sufficient to
fulfill the data requirement, or the data which EPA does
possess are flawed scientifically in a manner that cannot
be remedied by clarification or additional information.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no MRID
number has been assigned. Refer to the Bibliography Appendices
for a complete citation of the study.
65
-------
TGUIDE-3
6. Must additional data be submitted? (Column 6). This column
indicates whether the data must be submitted to the Agency. If
column 3 indicates that the Agency already has data, this column
will usually indicate NO. If column e indicates that the Agency
has only partial data or no data, this column will usually
indicate YES. In some cases, even though the Agency does not
have the data, EPA will not require its submission because of
the unique characteristics of the chemical; because data on
another chemical can be used to fulfill the data requirement; or
because the data
requirement has been waived or reserved. Any such unusual
situations will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column t requires
that data be submitted, this column indicates when the data are
to be submitted, based on the issuance date of the Registration
Standard. The timeframes are those established either as a
result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
66
-------
Table A
Generic Data Requirements for Diazinon
Data Requirement
Part 158. Subpart C. ProrhKt Qlgms-try
Product Identity and Composition
61-2 - Description of Beginning
Materials and Manufacturing
Process
61-3 - Discussion of Formation
of Impurities
Analvsis and Certification of Product
62-1 - Preliminary Analysis of
Product Samples
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
Composition
TGAI
TGAI
Incrredi ent s
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or Bibliographic
Partially) Citation
Nol/
Nbl/
Nbl/
Nbl/
Nbl/
Nbl/
Nbl/
Nbl/
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Ye&2/
Yes3-/
Yes4/
Yes5-/
Yes5-/
Yes5-/
Yes5-^/
Yes5-^/
Timeframe
For Data3/
Submission
9 Months
9 Months
12 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-------
00
Table A
Generic Data Requirements for Diazinon (cont'd)
Data Requirement
Part 158. Subpart C. Product Chemistry
Physical and Chemical Characteristics
63-7 - Density, Bulk: Density, or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/Water Partitioning
Composition
(cont'd)
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or Bibliographic
Partially) Citation
Nbi/
Nbi/
Nbi/
Nbi/
Nbi/
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Yes*/
Yes^/
Yes^/
Yes^/
Yes^S/
Timeframe
For Data
Submission
9 Months
9 Months
9 Months
9 Months
9 Months
Coefficient
63-12 - pH
63-13 - Stability
Other Requirements
64-1 - Submittal of Samples
TGAI
TGAI
N/A
9 Months
9 Months
N/A
N/A
No
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Part 158, Subpart C. Product Chemistry Footnotes
a/ For those data requirements identified in the May 1987 Comprehensive Data Call-in, the operative due dates are those
stipulated in that document or as officially extended by the EPA in response to registrant's request. For any new
data requirement imposed by this Registration Standard, the operative due dates are those imposed under this
Registration Standard.
17 Although product chemistry may have been submitted in the past, the Agency has determined that these data must be
resubmitted for each pesticide. New data requirements have been introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
27 Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition, the name and address
of the manufacturer, producer, or supplier of each beginning material must be provided, along with information
regarding the properties of each beginning material used to manufacture each product.
.37 A detailed discussion of all impurities that are or may be present at > 0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted.
47 Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for which
a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each analytical
method used.
57 Physicochemical characteristics (color, physical state, odor, melting point, specific gravity, solubility, vapor
pressure, dissociation constant, partition coefficient, pH, and stability) as required in 40 CFR 158.190 and more
fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
£/ Data required if the technical chemical is a solid at room temperature.
I/ Data required if the technical product is a liquid at room temperature.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Part 158. Suboart C. Product Chemistry Footnotes (cont'd)
fi/ Data required if the technical product is organic or nonpolar.
2/ Data required if the technical substance is dispersible in water.
-------
Table A
Generic Data Requirements for Diazinon
Data Requirement
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Composition Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Timeframe
For Data-3/
Submission
S158.240 Residue Chemistry
171-2 - Chemical Identity^/
171-3 - Directions for Use
171-4 - Nature of the Residue
(Metabolism) - Plant
171-4 - Nature of the Residue
(Metabolism) - Livestock
171-4 - Residue Analytical Methods
- Plant Residues
- Animal Residues
(See Index)
PAIRA
PAIRA & Plant
Metabolites
TGAI &
Metabolites
171-4 - Storage Stability Data
TEP and
Metabolites
No
No
Partially
No
00034132,00057235,
00061988,00089632,
00089634,00090324,
00090343,00125096,
00125557,00125620,
00127229,00129308,
00131006,00135470,
00135471,00140118
Yes2-/
Yes^/
18 Months
18 Months
18 Months
18 Months
(90 Days
for
(Protocol)
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Data Requirement
§158.240 Residue Chemistry
171-4 - Magnitude of the Residue in
- Root and Tuber Vegetables
o Beets (Garden)
o Carrots
o Parsnips
o Potatoes
(Processed)
o Radishes
o Rutabagas
o Sugar Beet Roots
(Processed)
o Sweet Potatoes
o Turnip Roots
Composition
Plants
Group
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Partially)
Partially
Partially
Partially
Partially
No
Partially
No
Partially
No
Partially
Partially
Bibliographic
Citation
00125078
00108982
00108982
00106977
00033669,00108982
00055415
00106977
00033245,00033670,
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Yes6-/
Yes2/
Yes^/
Yes9-/
Yes10/
Yes!!/
Yes12/
YesJ-2/
Yesi4/
Ye&L5-/
YeslS/
Timeframe
For Data
Submission
18 Months
18 Months
18 Months
18 Months
24 Months
18 Months
18 Months
18 Months
24 Months
18 Months
18 Months
00108982
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Data Requirement
Composition
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Timeframe
For Data
Submission
S158.240 Residue Chemistry
171-4 - Magnitude of the Residue in Plants (cont'd)
- Leaves of Root and Tuber
Vegetables Group
u>
o Beet Greens
o Chicory
o Sugar Beet Tops
o Turnip Tops
- Bulb Vegetables Group
o Onions (Dry Bulb)
- Leafy Vegetables Group
o Celery
o Endive (Escarole)
o Lettuce
o Parsley
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
NO
NO
Partially
Partially
Partially
Partially
Partially
Partially
Partially
00055429 }
00033245,00108982 Yes20-/
00089485
Ye&2i/
00057235,00108980 Yes22/
00108982 Yes23-/
00118036 Yes2^/
00108982 Yes25-/
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Data Requirement
$158.240 Residue Chemistry
171-4 - Magnitude of the Residue in
- Curcubit Vegetable Group
o Winter Squash
- Citrus Fruits Group
o Grapefruit
o Lemons
o Limes
o Oranges
o Processed Commodities
- Pome Fruit Group
o Apples (Processed)
Composition
Plants (cont'd)
(cont'd)
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Partially)
Partially
Partially
Partially
Partially
Partially
No
No
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?
00108982 Yes^0-/
00057665 Yes5-^/
00125096 Yes^=/
00057665 Yes5-i/
00032884 , 00125096 Yes^/
Yes5-2/
Yes53/
Yes54/
Timeframe
For Data
Submission
18 Months
18 Months
18 Months
18 Months
18 Months
24 Months
18 Months
24 Months
o Pears
TEP
NO
yes55/
18 Months
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Ln
Data Requirement
S158.240 Residue Chemistry
Composition
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Partially)
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?
Timeframe
For Data
Submission
171-4 - Magnitude of the Residue in Plants (cont'd)
- Stone Fruit Group
o Apricots
o Cherries
o Nectarines
o Peaches
o Plums (Fresh Prunes)
(Processed)
- Small Fruits and Berries
o Blackberries
o Blueberries
o Boysenberries
o Cranberries
o Dewberries
TEP
TEP
TEP
TEP
TEP
TEP
Group
TEP
TEP
TEP
TEP
TEP
Partially
Partially
Partially
Partially
No
No
Partially
Partially
Partially
Partially
No
00108980 Yes5-^/
00057235,00061987 Yes5-?/
00108980 Yes5-^/
00108980 Yes5-^/
Yes6-!/
00055419 Yes^2/
00055418 Yes6-3-/
00055420 Yes6-^/
00108982 Yes6-5-/
YesS6/
18 Months
18 Months
18 Months
18 Months
18 Months
24 Months
18 Months
18 Months
18 Months
18 Months
18 Months
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Data Requirement
$158.240 Residue Chemistry
171-4 - Magnitude of the Residue in
- Miscellaneous Commodities
o Cottonseed (Processed)
o Figs (Processed)
o Hops (Processed)
o Kiwi fruit
o Mushrooms
o Olives (Processed)
o Peanuts (Processed)
o Pineapple
o Pineapple (Processed)
Composition
Plants (cont'd)
(cont'd)
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Partially)
Partially
No
Partially
No
Partially
No
No
Partially
Partially
No
Partially
No
Partially
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?
00032881 Yes23/
Yes24/
00089485 Yes^5-/
Yes96/
00089485 Yes9-^/
Yes98/
Yes22/
00066159,00140118 Yes^O/
00089442 Yesi°-i/
YeslQ2/
00033671 Yes^0-3-/
YeslQ4/
00055414,00055425, Yes^/
YeslQ6/
Timeframe
For Data
Submission
18 Months
24 Months
18 Months
24 Months
18 Months
24 Months
18 Months
18 Months
18 Months
24 Months
18 Months
24 Months
18 Months
24 Months
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Data
S158.
171-4
171-4
Requirement
240 Residue Chemistry
- Magnitude of the Residue in
- Miscellaneous Commodities
o Sugarcane (Processed)
o Tobacco
o Watercress
- Magnitude of the Residue in
Meat/Mi Ik/Poul try/Eggs
- Fat, Meat, and Meat By-
products of Beef and
Dairy Cattle and Sheep
- Milk
— Pnnl-t-rv ?ind Frrrr.c;
Composition
Plants (cont'd)
(cont'd)
TEP
TEP
TEP
TEP
TGAI & Plant
Metabolites
TGAI & Plant
Metabolites
THAT K. Plarrf-
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Partially)
Partially
No
No
Partially
Partially
Partially
Psr-H 3"! "Iv
Must Additional
Data Be Submitted Timef rame
Bibliographic Under FIFRA Section For Data
Citation 3(c)(2)(B)? Submission
00106977 Yesi°-2/ 18 Months
Yesi°-8/ 24 Months
Yesi0-2/ 18 Months
00057665 Yesii0-/ 18 Months
00089634,00090250, ReservedHl^iiS/
00090343,00125557
05005830
nnomR^ p0c.OT-tr/villl ,1157
Metabolites
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Data Requirement
Composition
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Partially)
Bibliographic
Citation
Most Additional
Data Be Submitted.
Under FIFRA Section
3(C)(2)(B)?
Timeframe
For Data
Submission
5158.240 Residue Chemistry
171-4 - Magnitude of the Residue in
Fish and Shellfish
- Fish
00
171-4 - Magnitude of the Residue
in Drinking and Irrigation
Water
171-4 - Magnitude of the Residue
Resulting from Treatment
of Food Handling
Establishments
TGAI & Plant
Metabolites
TEP
PAIRA
TEP
Partially
00084599,00109994
18 Months
18 Months
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
§158.240 Residue Chemistry Footnotes
Mote: As used in these footnotes, the term "residues of concern" or "residues of toxicological concern" means the
"total toxicological residue" as defined in EPA Guidelines Section 0, Residue Chemistry, and using the toxicological
testing methods as detailed in Section F, Hazard Evaluation: Humans and Domestic Animals. Residues of parent
diazinon, any toxicologically significant organophosphorus impurities, degradates, and metabolites, as well as
tetraethylpyrophosphate (TEPP) or sulfur derivatives of TEPP are of concern to the Agency and are covered by this
definition. All requirements for determination of residues "in or on" require determination both in and on the
specific crop/commodity/site.
a/ For those data requirements identified in the May 1987 Comprehensive Data Call-in, the operative due dates are
those stipulated in that document or as officially extended by the EPA in response to registrant's request. For
any new data requirement imposed by this Registration Standard, the operative due dates are those imposed under
this Registration Standard.
!/ The same chemical identity data are required as under §158.170, with emphasis on impurities that could constitute
residue problems. Refer to Product Chemistry Data Requirements tables.
2/ Data depicting the uptake, distribution, and metabolism of ring-labeled [14C] diazinon in representative mature
crops, including a tree fruit such as peaches, and cotton, following soil and foliar application at a rate
sufficiently high to permit complete -^-residue identification are required.
Representative samples from these tests must also be analyzed using accepted enforcement methods to ascertain that
these methods will determine all metabolites of concern.
3/Animal metabolism studies utilizing ruminants and poultry are required. Ruminant studies must include a study
involving oral administration of [-^C] ring-labeled diazinon to cattle and a study involving the registered direct
animal treatment for sheep using [14C] ring-labeled diazinon. Sheep must be treated with an appropriate
formulation at 0.52 Ib ai/100 gal or an amount that will result in sufficient residues in the tissues and milk for
characterization. A maximum number of applications and a minimum interval between applications must be proposed,
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
and the required study must reflect the maximum use regiment of treatments thus permitted. Poultry studies are
required utilizing ring- labeled [14C] diazinon administered orally. Oral administrations for ruminant and poultry
studies must be made for at least 3 consecutive days. For all studies, animals must be sacrificed within 24 hours
of cessation of dosing. Milk and eggs must be collected twice daily throughout the duration of the study.
Residues must be characterized in muscle, fat, kidney, liver, milk, and eggs. All studies must be conducted
utilizing sufficiently high doses to permit complete characterization of residues in these commodities.
Tissues of [--C] diazinon-dosed animals must also be analyzed by methods approved for enforcement to verify
whether compounds of toxico logical concern have been adequately characterized.
4/ Additional methods, validation data, and residue data (for representative commodities) are required if the
metabolism studies requested in 171-4 (Nature of the Residue in Plants and Nature of the Residue in Animals)
indicate that additional metabolites constitute residues of toxico logical concern in plants or animals.
5/ All of the plant residue and animal feeding data required under this Standard must be accompanied by information
pertaining to the conditions and duration of sample storage prior to residue analysis and on the stability of
o diazinon under the storage conditions used. If the required metabolism data indicate the presence of residues of
toxicological concern in plant and animal commodities, data depicting the stability of such residues in storage
are also required.
To support crop residue data, storage stability studies must be conducted on both weathered samples and fortified
frozen samples of one representative crop from each crop grouping (40 CFR §180.34) on which registered uses of
diazinon exist. Analyses of each crop must be conducted over a time period that includes the time interval that
the raw agricultural commodity (RAC) is held in frozen storage prior to the crop residue analysis. To support
residue data on processed commodities, fortified storage stability data are required for all processing studies
submitted to the Agency. Analyses must be conducted over a time period that includes the frozen storage RAC prior
to processing and each processed commodity prior to the residue analysis. Acceptable protocols must be submitted
to the Agency ninety (90) days after receipt of this Notice. The protocols must be approved by the Agency prior
to initiating the studies.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
§158.240 Residue Chemistry Footnotes (cont'd)
Storage stability data using weathered sanples. Data are required on the parent compound in which crop
samples field treated with a typical end-use product are frozen immediately upon harvesting. The integrity of the
samples must be maintained by freezing. The samples must be analyzed for diazinon on the day they arrive at the
analytical laboratory, and then stored frozen and analyzed periodically for diazinon during the time intervals
specified in the Agency approved protocols.
(b) Storage stability data using fortified samples. Data are required on diazinon and metabolites of concern in
which a group of untreated samples of RACs and process crops are fortified (spiked) with only diazinon (pure
active ^ ingredient) and other groups are fortified individually with each metabolite of concern. Immediately after
fortification, the samples fortified with diazinon must be analyzed for diazinon and samples fortified with other
metabolites of concern must be analyzed for only the metabolite with which the sample was fortified. Sample
integrity must be maintained by freezing, and analyses for diazinon and metabolites must be conducted during the
time intervals specified in the Agency approved protocols.
(c) _ Storage stability data for livestock/poultry feeding studies. If cattle and poultry feeding studies are
required (see footnote 111), fortified storage stability studies will be required on all animal commodities (i.e. ,
tissues, milk and eggs) for which residue data are submitted to the Agency. Analyses must be conducted over a
time period that includes the time interval that each commodity is held in frozen storage prior to residue
analyses .
6/ Residue data are required to determine diazinon residues of concern in or on beets resulting from the following
full-season application schedule: i) preplant broadcast soil application of a WP, EC, and G formulation (each in
separate tests) at 10 Ib ai/A; and ii) multiple foliar applications of a WP, EC, and D formulation (each in
separate tests) at 0.5 Ib ai/A. The registrant must propose a maximum number of applications per season or
maximum seasonal use rate for the label, and the required data must be produced using these maximums. Separate
tests must be conducted using ground and aerial equipment. The tests must be conducted in Oregon, Texas,
California, New York, and Wisconsin.
I/ Residue data are required to determine diazinon residues of concern in or on carrots resulting from the following
full-season application schedule: 1) preplant broadcast soil application of a G, WP, and EC formulation (each in
separate tests) at 2 Ib ai/A at planting time; and ii) foliar application of a D, WP, and EC formulation (each in
separate tests) at 0.5 Ib ai/A; carrots must be harvested 10 days after the last application if multiple
treatments are used (see below). In additional tests, carrots must be harvested 14 days following the last foliar
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
application of 0.5% PrL formulation. Separate tests must be made using ground and aerial equipment. The
registrant must propose a maximum number of foliar and postemergence broadcast soil applications allowed per
season or maximum seasonal use rate for the label and the required data must be produced using these maximums.
Separate tests must be conducted using ground and aerial equipment. Tests must be conducted in California,
Michigan, Texas, and Washington.
8/ Residue data are required to determine diazinon residues of concern in or on parsnips. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be tested on
parsnips, or b) indicate support of the use on radishes and turnips and request that the required data for those
use patterns be used to support the use on parsnips.
2/ Residue data are required to determine diazinon residues of concern in or on potatoes resulting from the following
full-season application schedule: i) preplant broadcast soil application of a G, EC, and WP formulation (each in
separate tests) at 6 Ib ai/A; ii) at plant soil (band) application of a G formulation at 3 Ib ai/A; and, iii)
multiple foliar applications (by ground and in separate tests, aerial equipment) of an EC and WP formulation (each
in separate tests) at 0.083 oz/gal and (in separate tests) a D formulation at 2 Ib ai/A. Potato samples must be
harvested 35 days after the last foliar application. The registrant must propose a maximum permissible number of
foliar applications per season or maximum seasonal use rate for the label, and the require data must be produced
using these maximums. Tests should be conducted in Idaho, Washington, Maine, California, North Dakota, Wisconsin,
and Colorado.
IP./ Residue data are required to determine diazinon residues in granules, wet and dried peels, and dried chips from
potatoes bearing measurable weathered residues. If residues concentrate in either of these processed commodities,
appropriate food/feed additive tolerances must be proposed.
Residue data are required to determine diazinon residues of concern in or on radishes resulting from the following
full-season application schedule: i) preplant broadcast soil application of G, EC, and WP formulation (each in
separate tests) at 10 Ib ai/A; ii) soil application of a G, EC, and WP formulation (each in separate tests) at 0.7
oz/1000 feet of row at-planting; iii) transplant drench application of a WP and EC formulation (each in separate
tests) at 2 Ib ai/100 gal/A; and iv) foliar application of a WP and EC formulation at 0.5 Ib ai/A, and a D formu-
lation at 1.6 Ib ai/A (each in separate tests). Radishes must be harvested 10 days after the last application of
each treatment. In separate tests, radishes must be harvested 14 days after the last foliar application of the
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
0.5% PrL; separate tests must be conducted using ground and aerial equipment. The registrant must propose a
maximum seasonal use rate of maximum number of treatments per season, for preplant broadcast soil, soil, foliar,
and transplant water applications, for the label and the required data must be produced using these maximums.
Tests must be conducted in California, Florida, and Michigan.
12/ Although a tolerance of 0.75 ppm has been established for residues of diazinon in or on rutabagas, there are no
current federally registered products with this use pattern. No data are available to assess the adequacy of the
tolerance for diazinon residues in or on rutabagas. The registrant may propose a use for diazinon on rutabagas
and must submit appropriate supporting data. If the proposed use for rutabagas is similar to the registered uses
of diazinon on carrots, radishes, or parsnips, then data required in support of tolerances for these commodities
may be translated to rutabagas. If such use directions and supporting data are not submitted, the Agency will
propose revocation of this tolerance through the Tolerance Revocation Program.
13/ Residue data are required to determine diazinon residues of concern in or on sugar beet roots resulting from the
following full-season application schedule: i) preplant, broadcast soil application of a G, WP, and EC formu-
lation (each in separate tests) at 4 Ib ai/A; ii) soil (band) application of a G formulation at 2 Ib ai/A at-
oo planting, and at 1.5 Ib ai/A early preemergence; and iii) multiple foliar applications (by ground, and in
separate tests, aerial equipment) of a WP, and in separate tests, an EC formulation at 0.5 Ib ai/A. The
registrant must propose a maximum foliar use rate or maximum number of foliar treatments per season for the label,
and the required data must be produced using these maximums. These tests must be conducted in Idaho, Minnesota,
California, North Dakota, and Michigan, and must reflect a 0-day preharvest interval.
14/ Residue data are required to determine diazinon residues in dehydrated pulp, molasses, and refined sugar from
sugar beets bearing measurable weathered residues. Exaggerated rates of application may be necessary to achieve
such residue levels. If residues are found to be concentrate in any of the processed commodities, then
appropriate food/feed additive tolerances must be proposed.
15/ Residue data are required to determine diazinon residues of concern in or on sweet potatoes. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be tested; or
b) indicate support of the use on potatoes and request that the required data for that use pattern be used to
support the use on sweet potatoes.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
16/ Residue data are required to determine diazinon residues of concern in or on turnip roots resulting from the
following full-season application schedule: i) preplant broadcast soil application of G, WP, and EC formulations
(each in separate tests) at 10 Ib ai/A; ii) at-plant soil application of a G, EC, and WP formulation (each in
separate tests) at 0.7 oz/1000 feet of row at-planting; iii) transplant water application of a WP and EC
formulation (each in separate tests) at 0.5 Ib ai/A.; and iv) foliar application of a WP and EC formulation at 0.5
Ib ai/A, a 0.5% PrL, and a D formulation at 1.6 Ib ai/A (each in separate tests). Turnips must be harvested 10
days after the last foliar application of each treatment. Tests must be conducting using ground and aerial
equipment. The registrant must propose a maximum seasonal use rate or maximum number of foliar treatments per
season for the label, and the required data must be produced using these maximums. Tests must be conducted in
Tennessee, Florida, or Georgia and Arizona, and/or California.
17_/ Residue data are required to determine diazinon residues of concern in or on garden beet tops harvested following
a full-season application schedule: i) preplant broadcast soil application of a WP, EC, and G formulation (each
in separate tests) at 10 Ib ai/A; and ii) foliar applications of a WP, EC, and D formulation (each in separate
tests) at 0.5 Ib ai/A. The registrant must propose a maximum seasonal use rate or maximum number of applications
per season for the label, and the required data must be produced using these maximums. Tests must be conducted in
Oregon, Texas, California, New York, and Wisconsin.
00
-p-
18/ Although a tolerance of 0.7 ppm has been established for residues of diazinon in or on red chicory tops (also
known as radicchio) there are no current federally registered products with directions for use on chicory. No
data are available to assess the adequacy of the tolerance for diazinon residues in or on red chicory tops. The
registrant may propose a use for diazinon on chicory and must submit appropriate supporting data. If such use
directions and supporting data are not submitted, the Agency will propose revocation of this tolerance through the
Tolerance Revocation Program.
19/ Residue data are required to determine diazinon residues of concern in or on sugar beet tops resulting from the
following full-season application schedule: i) preplant, broadcast soil application with a G, WP, and EC
formulation (in separate tests) at 4 Ib ai/A; ii) soil application at-planting time (band) with a G formulation a
2 Ib ai/A; iii) foliar applications (by ground, and in separate tests, aerial equipment) with a G formulation at
0.5 Ib ai/A; and iv) early postemergent soil application at 1.5 Ib ai/A. The registrant must propose a maximum
seasonal use rate or maximum number of foliar applications per season for the label, and the required data must be
produced using these maximums. Test must be conducted in Idaho, Minnesota, California, North Dakota, and
Michigan, and must incorporate a 0-day PHI.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
2Q/ Residue data are required to determine diazinon residues of concern in or on turnip tops resulting from the
following full-season application schedule: i) preplant broadcast soil application of G, WP, and EC formulations
(each in separate tests) at 10 Ib ai/A; ii) soil application of a G, EC, and WP formulation (each in separate
tests) at 0.7 oz/1000 feet of row at-planting; iii) transplant water application of a WP and EC formulation (each
in separate tests) at 0.5 Ib ai/A; and iv) foliar application of a WP and EC formulation at 0.5 Ib ai/A, a 0.5%
PrL, and a D formulation at 1.6 Ib ai/A (each in separate tests). Turnips must be harvested 10 days after the
last foliar application of each treatment. Tests must be conducted using ground and aerial equipment. The
registrant must propose a maximum seasonal use rate or maximum number of foliar applications per season for the
label, and the required data must be produced using these maximums. Tests must be conducted in California, Texas,
Arizona, Georgia, Florida, and Tennessee.
2i/ Residue data are required to determine diazinon residues of concern in or on dry bulb and green onions following a
full-season application schedule that includes: i) preplant broadcast soil incorporation of a G, WP, and EC (each
in separate tests) at 4 Ib ai/A; ii) at-plant, in-furrow soil application of a D, EC, G, and WP (each in separate
tests), at 1.4, 1, 1, and 1 Ib ai/A, respectively; and iii) multiple foliar applications (by ground, and in
separate tests, aerial equipment) of a D at 1.2 Ib ai/A, a WP at 0.5 Ib ai/A, and an EC at 0.5 Ib ai/A (each in
separate tests). Tests must reflect a 10-day PHI. The registrant must propose a maximum seasonal use rate or
maximum number of foliar and preplant applications per season for the label, and the required data must be
produced using these maximums. For green onions, tests must be conducted in Arizona, California, and Texas; for
dry onions, tests must be conducted in California, New York, Oregon, and Texas. In addition, data are required
for one additional Allium spp. group member.
22/ Residue data are required to determine diazinon residues of concern in or on untrimmed celery resulting from the
following full-season application schedule: 1) preplant broadcast soil application of a G, WP, and EC (each in
separate tests) at 4 Ib ai/A; and ii) multiple foliar applications (by ground and, in separate tests, aerial
equipment) of a WP, EC, and D (each in separate tests) at 0.5 Ib ai/A. The required tests must incorporate a 10-
day PHI. The registrant must propose a maximum seasonal foliar use rate or maximum number of foliar treatments
per season for the label, and the required data must be produced using these maximums. Tests must be conducted in
California, Florida, and Michigan.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
$158.240 Residue Chemistry Footnotes (cont'd)
23/ Residue data are required to determine diazinon residues of concern in or on endive. The registrant must contact
the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and either a)
request a determination of the specific formulations, rates, and application schedule to be tested on endive; or
b) indicate support of the use on lettuce and request that the required data for that use pattern be used to
support the use on endive.
247 Residue data are required to determine diazinon residues of concern in or on untrimmed lettuce (head and leaf
varieties) resulting from the following full-season schedule; i) preplant broadcast soil application of a G, WP,
and EC (each in separate tests) at 10 Ib ai/A; and ii) multiple foliar applications (by ground and, in separate
tests, aerial equipment) of a WP, D, and EC formulation (each in separate tests) at 0.5 Ib ai/A. Required tests
must incorporate a 10-day PHI. The registrant must propose a maximum seasonal use rate or maximum number of
applications per season for the label, and the required data must be produced using these maximums. Tests must be
conducted in California, Arizona, and Florida.
257 Residue data are required to determine diazinon residues of concern in or on parsley resulting from the following
full-season application schedule: i) preplant broadcast soil application of a G, WP, and EC (each in separate
tests) at 4 Ib ai/A; and ii) multiple foliar applications (by ground and aerial equipment) of a D formulation at
1.6 Ib ai/A. These tests must incorporate a 12-day PHI. The registrant must propose a maximum seasonal foliar
use rate or maximum number of foliar treatments per season for the label, and the required data must be produced
using these maximums. Tests must be conducted in California, Florida, New Jersey, and Texas.
267 Residue data are required to determine diazinon residues of concern in or on spinach resulting from the following
full-season application schedule: i) preplant broadcast soil application of a G, WP, and EC (each in separate
tests) at 4 Ib ai/A; and ii) multiple foliar applications (by ground and, in separate tests, aerial equipment) of
a WP, EC, and D (each separate tests) at 0.5 Ib ai/A. The required tests must incorporate a 10-day PHI. The
registrant must proposed a maximum seasonal foliar use rate or maximum number of foliar treatments per season for
the label, and the required data must be produced using these maximums. Tests must be conducted in California and
Texas.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
5158.240 Residue Chemistry Footnotes (cont'd)
277 Residue data are required to determine diazinon residues of concern in or on swiss chard. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and
either a) request a determination of the specific formulations, rates, and application schedule to be tested on
swiss chard; or b) indicate support of the use on parsley and request that the required data for that use pattern
be used to support the use on swiss chard.
287 Residues data are required to determine diazinon residues of concern in or on broccoli harvested 5 days after
completion of the following full-season treatment schedule: i) preplant soil broadcast incorporation of a G, WP,
and EC (each in separate tests) at 4 Ib ai/A; ii) at-plant soil application of a G, WP, and EC (each in separate
tests) at 0.7 oz ai/1000 ft of row; iii) transplant drench treatment with an EC and a WP (each in separate tests)
at 0.5 Ib ai/100 gal, applied at 300 gal/A (for an effective use rate of 1.5 Ib ai/A); and iv) multiple foliar
applications (by ground and in separate tests, by aerial equipment) of a D at 1.6 It) ai/A, and a WP and an EC
(each in separate tests) at 0.5 It) ai/A. The registrant must propose a maximum seasonal use rate or maximum
number of foliar treatments per season, and the required data must be produced using these maximums. Tests must
be conducted in California Texas, and Oregon.
Residue data are also required to support the Special Local Need (SLN) registration on broccoli. Tests in
California are required using before-transplant foliar application^) (by ground and air in separate tests) of aWP
at 3 Ib ai/A. The registrant must propose a maximum seasonal use rate or maximum number of treatments per year
for the SLN label, and the required data must be produced using these maximums and a 5-day PHI. Revised SLN
labeling must be submitted that specifies the total number of applications permitted per season and the interval
between these applications. Alternatively, the registrant may request voluntary cancellation of the SLN
registration in California that permits this use.
29/ Residue data are required to support the registered uses of diazinon on Brussels sprouts. If a crop group
tolerance supported by data is not obtained, then residue data are required to determine diazinon residues of
concern in or on Brussels sprouts harvested 7 days after completion of the following full-season treatment
schedule: i) preplant soil broadcast incorporation of a G, WP, and EC (each in separate tests) at 4 Ib ai/A ii)
at-plant soil application of a G, WP, and EC (each in separate tests) at 0.7 oz ai/1000 ft of row; iii) transplant
drench treatment with an EC and a WP (each in separate tests) at 0.5 Ib ai/100 gal, applied at 300 gal/A (for an
effective use rate of 1.5 It) ai/A); and iv) multiple foliar applications (by ground and, in separate tests, by
aerial equipment) of a D at 1.6 Ib ai/A, and a WP and an EC (each in separate tests) at 0.5 Ib ai/A. The
registrant must propose a maximum seasonal use rate or maximum number of foliar applications per season for the
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
5158.240 Residue Chemistry Footnotes (cont'd)
label, and the required data must be produced using these maximums. Tests must be conducted in California and New
York.
Residue data are also required to support the SLN registration on Brussels sprouts. Tests in California are
required using before-transplant foliar application^) (by ground and air in separate tests) of a WP at 3 Ib ai/A.
The registrant must propose a maximum seasonal use rate or maximum number of soil treatments per year for the
label, and the required data must be produced using these maximums and a 7-day PHI. Revised SLN labeling must be
submitted that specifies the total number of applications permitted per season and the interval between these
applications. Alternatively, the registrant may request voluntary cancellation of the SLN registration in
California that permits this use.
3Q/ Residue data are required to determine diazinon residues of concern in or on cabbage receiving the following full-
season application schedule: i) preplant broadcast soil incorporation of a G, WP, and EC at 10 Ib ai/A (each in
separate tests); ii) at-plant soil application of a G, WP, and EC (each in separate tests) at 0.07 oz ai/1000 ft
of row; iii) transplant water drench application of a WP and an EC (each in separate tests) at 0.5 Ib ai/100 gal,
applied at 300 gal/A; and iv) multiple foliar applications of a D at 1.6 Ib ai/A, a WP at 0.5 Ib ai/A, and an EC
at 0.5 Ib ai/A (each in separate tests). These tests must incorporate a PHI of 7 days, and must be conducted in
go California, Florida, New York, Texas, and Wisconsin.
00
Residue data are also required to support the SLN registrations on cabbage. Tests in California are required
using before-transplant foliar application^) (by ground and air in separate tests) of a WP at 3 Ib ai/A. The
registrant must propose a maximum seasonal use rate or maximum number of soil treatments per year for the SLN
label, and the required data must be produced using these maximums and a 7-day PHI. Revised SLN labeling must be
submitted that specifies the total number of applications permitted per season and the interval between these
applications. Alternatively, the registrant may request voluntary cancellation of the SLN registration in
California that permits this use.
31 Residue data are required to support the registered uses of diazinon on cauliflower. If a crop group tolerance
supported by data is not obtained, then residue data are required to determine diazinon residues of concern in or
on cauliflower harvested 5 days after completion of the following full-season treatment schedule: i) preplant
soil broadcast incorporation of a G, WP, and EC (each in separate tests) at 4 Ib ai/A; ii) at-plant soil
application of a G, WP, and EC (each in separate tests) at 0.7 oz ai/1000 ft of row; iii) transplant drench
treatment with an EC and a WP (each in separate tests) at 0.5 Ib ai/100 gal, applied at 300 gal/A (for an
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
5158.240 Residue Chemistry Footnotes (cont'd)
effective use rate of 1.5 Ib ai/A); and iv) multiple foliar applications (by ground and in separate tests, by
aerial equipment) of a D at 1.6 Ib ai/A, and a WP and an EC (each in separate tests) at 0.5 Ib ai/A. The
registrant must propose a maximum seasonal use rate or maximum number of foliar applications per season for the
label, and the required data must be produced using these maximums. Tests must be conducted in California, New
York, Oregon, and Texas.
Residue data are also required to support the SLN registration on cauliflower. Tests in California are required
using before-transplant foliar application^) (by ground and air in separate tests) of a WP at 3 Ib ai/A. The
registrant must propose a maximum seasonal use rate or maximum number of soil treatments per year for the label,
and the required data must be produced using these maximums and a 5-day PHI. Revised SLN labeling must be
submitted that specifies the total number of applications permitted per season and the interval between these
applications. Alternatively, the registrant may request voluntary cancellation of the SLN registration in
California that permits this use.
32/ Residue data are required to support the registered uses of diazinon on collards. If a crop group tolerance
supported by data is not obtained, then residue data are required to determine diazinon residues of concern in or
on collards harvested 10 days after completion of the following full-season treatment schedule: i) preplant soil
broadcast incorporation of a G, a WP, and an EC (each in separate tests) at 4 Ib ai/A; ii) at-plant soil
application of a G, a WP, and an EC (each in separate tests) at 0.7 oz ai/1000 ft of row; iii) transplant drench
treatment with an EC and a WP (each in separate tests) at 0.5 Ib ai/100 gal, applied at 300 gal/A (for an
effective use rate of 1.5 Ib ai/A); and iv) multiple foliar applications (by ground and, in separate tests, by
aerial equipment) of a D at 1.6 Ib ai/A, and a WP and an EC (each in separate tests) at 0.5 Ib ai/A. The
registrant must propose a maximum seasonal use rate or maximum number applications per season for the label, and
the required data must be produced using these maximums. Tests must be conducted in Georgia, Florida, and
Virginia.
Residue data are also required to support the SLN registration on collards. Tests in California are required
using before-transplant foliar application^) (by ground and air in separate tests) of a WP at 3 Ib ai/A. The
registrant must propose a maximum seasonal use rate or maximum number of soil treatments per year for the label,
and the required data must be produced using these maximums and a 10-day PHI. Revised SLN labeling must be
submitted that specifies the total number of applications permitted per season and the interval between these
applications. Alternatively, the registrant may request voluntary cancellation of the SLN registration in
California that permits this use.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
5158.240 Residue Chemistry Footnotes (cont'd)
33/ Residue data are required to support the registered uses of diazinon on kale. If a crop group tolerance supported
by data is not obtained, then residue data are required to determine diazinon residues of concern in or on kale
harvested 10 days after completion of the following full-season treatment schedule: i) preplant soil broadcast
incorporation of a G, a WP, and an EC (each in separate tests) at 4 Ib ai/A; ii) at-plant soil application of G, a
WP, and an EC (each in separate tests) at 0.7 oz ai/1000 ft of row; iii) transplant drench treatment with an EC
and a WP (each in separate tests) at 0.5 Ib ai/100 gal, applied at 300 gal/A (for an effective use rate of 1.5 Ib
ai/A); and iv) multiple foliar applications (by ground and, in separate tests, by aerial equipment) of a D at 1.6
Ib ai/A, and a WP and an EC (each in separate tests) at 0.5 Ib ai/A. The registrant must propose a maximum
seasonal use rate or maximum number of applications per season for the label, and the required data must be
produced using these maximums. Tests must be conducted in New York and Virginia.
Residue data are also required to support the SLN registration on kale. Tests in California are required using
before-transplant foliar applications) (by ground and air in separate tests) of a WP at 3 Ib ai/A. The
registrant must propose a maximum seasonal use rate or maximum number of soil treatments per year for the label,
and the required data must be produced using these maximums and a 10-day PHI. Revised SLN labeling must be
submitted that specifies the total number of applications permitted per season and the interval between these
applications. Alternatively, the registrant may request voluntary cancellation of the SLN registration in
California that permits this use.
34/ Residue data are required to determine diazinon residues of concern in or on mustard greens harvest 10 days after
completion of the following full-season treatment schedule: i) preplant soil broadcast incorporation of a G, a
WP, and an EC (each in separate tests) at 4 Ib ai/A; ii) at-plant soil application of a G, a WP, and an EC (each
in separate tests) at 0.7 oz ai/1000 ft of row; iii) transplant drench treatment with an EC and a WP (each in
separate tests) at 0.5 Ib ai/100 gal, applied at 300 gal/A (for an effective use rate of 1.5 Ib ai/A); and iv)
multiple foliar applications (by ground and, in separate tests, by aerial equipment) of a D at 1.6 Ib ai/a, and a
WP and an EC (each in separate tests) at 0.5 Ib ai/A. The registrant must propose a maximum seasonal use rate or
maximum number of foliar applications per season for the label, and the required data must be produced using these
maximums. Tests must be conducted in Arizona, California, Florida, North California, and Texas.
Residue data are also required to support the SLN registration on mustard greens. Tests in California are
required using before-transplant foliar applications) (by ground and air in separate tests) of a WP at 3 Ib ai/A.
The registrant must propose a maximum seasonal use rate or maximum number of soil treatments per year for the
label, and the required data must be produced using these maximums and a 10-day PHI. Revised SLN labeling must be
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
submitted that specifies the total number of applications permitted per season and the interval between these
applications. Alternatively, the registrant may request voluntary cancellation of the SLN registration in
California which permits this use.
35/ Residue data are required to determine diazinon residues of concern in or on beans, including lima and snap beans,
resulting from the following full-season application schedule: i) preplant broadcast soil application of a G, WP,
and EC formulation (each in separate tests) at 10 Ib ai/A; and ii) multiple foliar applications of a WP and an EC
formulation (in separate tests) at 0.75 Xb ai/A, and a D formulation (in separate tests) at 1.4 Ib ai/A. Beans
must be harvested 7 days after the last foliar application. Tests must be conducted using ground, and in separate
tests aerial equipment. The registrant must propose a maximum seasonal use rate or maximum number of applications
per season for the label, and the required data must be produced using these maximums. Snap bean tests must be
performed in Wisconsin, New York, Oregon, Florida, and Michigan. Tests with lima beans must be conducted in
California, Delaware, Wisconsin, and Illinois.
367 Residue data are required to determine diazinon residues of concern in or on cowpeas. The registrant must contact
the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and either:
a) request a determination of the specific formulations, rates, and application schedule to be tested on cowpeas,
or b) indicate support of the use on peas and soybeans and request that the required data for those use patterns
be used to support the use on cowpeas.
JZ/ Residue data are required to determine diazinon residues of concern in or on peas (succulent and dry) following a
full-season application schedule: i) preplant broadcast soil application of a G, WP, and EC formulation (in
separate tests) at 10 Ib ai/A; and ii) multiple foliar applications (reflecting use of both ground and aerial
equipment) of a D and WP formulation (in separate tests) at 0.5 Ib ai/A. Samples must be harvested on the day of
the final foliar treatment. Tests must be conducted in Wisconsin, Washington, and Minnesota. The registrant must
propose a maximum seasonal use rate or maximum number of foliar and soil applications per season for the label,
and the required data must be produced using these maximums.
Residue data are required to determine residues of concern in or on dried peas and peas with pods (succulent)
harvested 7 days following the last of four foliar applications of a D formulation at 1.35 Ib ai/A. Tests must be
conducted in California. Alternatively, the registrant may request voluntary cancellation of SLN Registration
No. CA-800105, which permits this use in California.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
$158.240 Residue Chemistry Footnotes (cont'd)
Residue data are required to determine residues of concern in or on peas (succulent and dried) harvested after the
last of three soil drench applications (at 14- to 16-day intervals) with the 4 Ib/gal EC at 5 Ib ai/A. Tests must
be conducted in California using ground equipment. Alternatively, the registrant may request voluntary
cancellation of SEN Registration No. CA-830017, which permits this use in California.
J3§/ Residue data are required to determine diazinon residues of concern in or on soybeans resulting from the following
treatment regimen: i) preplant broadcast soil application of a G, WP, and EC formulation (each in separate
tests), at 4 Ib ai/A. Tests must be conducted using both ground, and in separate tests, aerial equipment. Tests
must be conducted in Arkansas, North Dakota, Texas, Kansas, and Missouri.
32/ Residues must be determined in meal, hulls, soapstock, crude oil, and refined oil processed from soybeans bearing
measurable weathered residues. If residues concentrate in any of these processed products, appropriate food/feed
additive tolerances must be proposed.
4Q/ Residue data are required to determine diazinon residues of concern in or on lima and snap beans vines and hay
resulting from the following full-season application schedule: i) preplant broadcast soil application of a G, WP,
and EC formulation (each in separate tests) at 10 Ib ai/A; and ii) multiple foliar applications of a WP and EC
formulation (in separate tests) at 0.75 Ib ai/A, and a D formulation at 1.4 Ib ai/A. Bean hay must be harvested 4
days after the last foliar application. Tests must be conducted using ground, and in separate tests, aerial
equipment. The registrant must propose a maximum seasonal use rate or maximum number of applications per season
and the interval between these applications for the label, and the required data must be produced using these
maximums. Snap bean tests must be conducted in Wisconsin, New York, Oregon, Florida, and Michigan. Tests with
lima beans must be conducted in California, Delaware, Wisconsin, and Illinois.
41/ Residue data are required to determine diazinon residues of concern in or on cowpea vines and hay. The registrant
must contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on cow pea vines and hay; or b) indicate support of the use on soybean hay and straw and request that the
required data for those use patterns be used to support the use on cowpea vines and hay.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
42/ Residue data are required to determine diazinon residues of concern in or on peas (succulent and dry) following a
full-season application schedule: i) preplant broadcast soil application of a G, WP, and EC formulation (in
separate tests) at 10 Ib ai/A; and ii) multiple foliar applications (reflecting use of both ground and aerial
equipment) of a D and WP formulation (in separate tests) at 0.5 Ib ai/A. Samples must be harvested on the day of
final foliar treatment. Tests must be conducted in Wisconsin, Washington, Minnesota, and Oregon. Studies must
incorporate a 4-day PHI. A pregrazing interval for vines and hay must be proposed. The registrant must propose a
maximum number of foliar applications per season for the label, and the required data must be produced using the
maximums.
Residue data are required to determine residues of concern in or on pea vines and hay harvested 7 days following
the last of four foliar applications of a D formulation at 1.35 Ib ai/A. Tests must be conducted in California,
and must incorporate a 7-day PHI. Alternatively, the registrant may request voluntary cancellation of SLN
Registration No. CA-800105, which permits this use in California.
Residue data are also required to determine residues of concern in or on pea vines and hay harvested after the
last of three soil drench applications at 14-day to 16-day intervals with the 4 Ib/gal EC at 5 Ib ai/A. Tests
must be conducted in California. Alternatively, the registrant may request voluntary cancellation of SLN
Registration No. CA-830017, which permits this use in California.
43/ The registrant must propose tolerances for soybean straw and hay, which are RACs of soybean and submit appropriate
supporting data, or established feeding/grazing restrictions. Data depicting diazinon residues of concern in or
on soybean forage resulting from the following treatment regimen: preplant broadcast soil application of a G, a
WP, and an EC formulation (each in separate tests), at 4 Ib ai/A. Tests must be conducted using both ground, and
in separate tests, aerial equipment. Tests must be conducted in Iowa, Illinois, Minnesota, Indiana, Mississippi,
and Ohio.
44/ Residue data are required to determine diazinon residues of concern in or on peppers treated with the following
full-season application regimen: i) preplant broadcast soil application of a G, WP, and EC formulation (each in
separate tests) at 4 Ib ai/A, and ii) multiple foliar applications of a D formulation at 1.6 Ib ai/A, and in
separate tests, a WP and an EC formulation at 0.267 Ib ai/A. Peppers must be harvested 5 days following the last
in a series of foliar applications. Tests must be conducted using ground, and in separate tests, aerial
equipment. The registrant must propose a maximum use rate or maximum number of applications per season for the
label, and the required data must be produced using these maximums. The required tests must support that number.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
s158.240 Residue Chemistry Footnotes (cont'd)
The tests most be conducted in Florida, California, Texas, North Carolina, and New Jersey.
45/ Residue data are required to determine diazinon residues of concern in or on tomatoes treated with the following
full-season application schedule: i) preplant broadcast soil application of a G, WP, and EC formulation (each in
separate tests) at 10 Ib ai/A; ii) multiple foliar applications of a D formulation at 1.6 Ib ai/A, and in separate
tests, a WP and an EC formulation at 0.75 Ib ai/A. Tomato samples must be harvested 3 days after the last dust
application and 1 day after the last spray application. Tests must be conducting using ground, and in separate
tests, aerial equipment; and iii) broadcast soil application of a D formulation, and in separate tests, a G
formulation at 1 Ib ai/A. For soil and foliar applications, the registrant must propose a maximum seasonal use
rate or maximum number of applications per season for the label, and the required data must be produced using
these maximums. Tests must be conducted in California and Florida.
Residue data are also required to support the SEN registrations for greenhouse-grown tomatoes. Residue data are
required to determine diazinon residues of concern in or on greenhouse-grown tomatoes harvested 3 days following
the last of multiple foliar tests, applied 7 to 10 days apart, using the 50% WP formulation (to be tested in North
California), and the 48% EC formulation (to be tested in Ohio) at 8 oz product/100 gal. In addition, multiple
foliar tests must be conducted in California on greenhouse-grown tomatoes harvested 1 day following the last
application at 1 1/8 tbsp of 48% EC product/1000 sq ft.
46/ Residue data are required to determine diazinon residues of concern in or on tomato puree, catsup, and juice
processed from tomatoes bearing measurable weathered residues. Exaggerated rates of application may be necessary
to achieve such residue levels.
47/ Residue data are required to determine diazinon residues of concern in or on cucumbers 7 days following the last
of multiple foliar applications with a D formulation at 1.6 Ib ai/A and a WP and EC (each in separate tests) at
0.5 Ib ai/A. All tests must include one preplant broadcast application of a WP, and EC, a G, and a D formulation
(separate tests for each) at 4 Ib ai/A. The registrant must propose a maximum seasonal foliar use rate, or a
maximum number of foliar applications per season for the label, and the required data must be produced using these
maximums. Tests must be conducted in California, Florida, Georgia, Michigan, North Carolina, South Carolina,
Texas, and Virginia.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
5158.240 Residue Chemistry Footnotes (cont'd)
48/ Tests depicting diazinon residues of concern in or on melons harvested 3 days after the last of multiple foliar
applications of a D formulation at 1.4 Ib ai/A and of WP and EC formulations at 0.75 Ib ai/A (each in separate
tests). Each of the above tests must include a preplant broadcast soil application of a WP, a D, a G, and an EC
formulation (separate tests for each) at 4 Ib ai/A. The registrant must propose a maximum foliar seasonal use
rate, or a maximum number of foliar applications per season for the label, and the required data must be produced
using these maximums. Watermelon tests must be conducted in California, Florida, Georgia, and Texas. Cantaloupe
tests should be performed in California and Texas.
49/ Residue data are required to determine diazinon residues of concern in or on summer squash resulting from the
following full-season application schedule: i) multiple foliar applications of a D formulation at 1.4 Ib ai/A and
of a WP and an EC formulation (each in separate tests), at 0.75 Ib ai/A; and ii) preplant broadcast soil applica-
tion of a WP, D, G, and an EC formulation (separate test for each) at 4 Ib ai/A. The registrant must propose a
maximum foliar seasonal use rate, or a maximum number of applications per season for the label, and the required
data must be produced using these maximums. Tests must be conducted in California, Florida, Georgia,
Massachusetts, Michigan, New Jersey, New York, North Carolina, and Texas.
50/ Residue data are required to determine diazinon residues of concern in or on winter squash. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be tested on
winter squash; or b) indicate support of the use on melons and request that the required data for that use pattern
be used to support the use on winter squash.
5>1/ Tests are required depicting residues of concern in or on lemons, oranges, and grapefruit harvested 21 days
following the last of: multiple foliar applications with a D formulation at 8 Ib ai/A, and WP and EC formulations
(in separate tests) at 10 Ib ai/A (1 Ib ai/100 in 1000 gal/A). The registrant must propose a maximum foliar
seasonal use rate or a maximum number of applications per season for the label, and the required data must be
produced using these maximums. Tests on oranges and grapefruit should be conducted in Florida. Tests on lemons
should be conducted in California.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
Residue data are required to support the SLN registration in Florida. Residue data are required to determine
diazinon residues of concern in or on grapefruit, oranges, and lemons harvested 21 days following the last of
multiple foliar applications with a 4 Ib/gal EC formulation at 0.5 Ib ai/100 gal water (applied at < 1000 gal/A).
The test must be conducted in Florida. Alternatively, the registrant may request voluntary cancellation of SLN
Registration No. FL-770036, which permits this use in Florida.
Residue data are required to support the SLN registrations in California. Residue data are required to determine
diazinon residues of concern in or on grapefruit, oranges, and lemons harvested 21 days following the last of
multiple applications with a 14% G formulation, broadcasted and incorporated at the maximum rate until the 19.6 Ib
ai/A per year limit has been achieved. Application of a 14% G formulation must be tested with both ground, and in
separate tests, aerial equipment (broadcast only). The tests must be conducted in California. If the data
support the tolerance, the registrant should amend the SLN labels so that all include the 19.6 Ib ai/A per year
limit and amend the label for the 5% G formulation to include the same maximum permitted use per season as the 14%
G formu-lation, or else propose a maximum number of applications. Alternatively, the registrant may request
voluntary cancellation of SLN Registration Nbs. CA-770033 (5% G), CA-760014 (14% G), and CA-810066 (14% G) which
permit this use in California.
..... . .
52/ Residue data are required to determine residues in citrus oil, molasses, and juice processed from whole citrus
fruits bearing measurable weathered residues. Exaggerated application may be necessary to achieve such residue
levels. If residues are found to concentrate in any of the processed commodities, appropriate food/feed additive
tolerances must be proposed.
5_3/ Residue data are required to determine diazinon residues of concern in or on apples harvested 14 days after the
last of eight foliar applications at 10-day intervals of i) a D formulation at 4 Ib ai/A (using ground and aerial
equipment in separate tests); ii) a WP and an EC formulation, in separate tests, at 2.8 Ib ai/A using both aerial
and low-volume ground equipment; and iii) a WP formulation at 4 Ib ai/A using high-volume ground equipment (0.5 Ib
ai/100 gal). Trials must be conducted in California, Michigan, New York, Pennsylvania, Washington, and Virginia.
Residue data are also required to support the SLN registration in California. Residue data are required to
determine residues of concern in or on apples treated according to the above treatment regimens, plus multiple
soil drench applications of the 4 Ib/gal EC formulation at 5 Ib ai/A. This test must be conducted in California.
Alternatively, the registrant may request voluntary cancellation of SLN Registration No. CA-830017, which permits
the soil drench method of California.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
§158.240 Residue Chemistry Footnotes (cont'd)
54/ Residue data are required to determine diazinon residues in wet and dry pomace, and juice processed from apples
bearing measurable weathered residues. Should residues concentrate in the processed apple products, the
registrant must propose appropriate food/feed additive tolerances.
557 Residue data are required to determine diazinon residues of concern in or on pears. The registrant must contact
the Agency, within the allowed ninety (90) day period for indicating to support this use, and either: a) request
a determination of the specific formulations, rates, and application schedule to be tested on pears; or b)
indicate support of the use on apples and request that the required data for that use pattern be used to support
the use on pears. The registrant should note that translated data may not be used to support a group tolerance.
56/ Residue data are required to determine diazinon residues of concern in or on apricots. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be tested on
apricots; or b) indicate support of the use on nectarines and request that the required data for that use pattern
be used to support the use on apricots.
In addition, data are lacking to support the existing SLN registrations in California which permit use of the 50%
WP, and 4 Ib/gal and 48% EC formulations at rates less restrictive than the Federal registrations. The registrant
must contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either a) request a determination of the specific formulations, rates, and application schedule to be tested
on apricots, or b) electing to indicate support of the use of nectarines and request that the required data for
that use pattern be used to support the use on apricots, or c) requesting voluntary cancellation of SLN Registra-
tion Nos. CA-810043, CA-810047 (foliar), and CA-830017 (soil drench) which permit these uses in California.
577 Residue data are required to determine diazinon residues of concern in or on sweet and sour cherries 10 days
following the last of five foliar applications of the following formulation (each in separate tests): i) an EC at
0.5 Ib ai/100 gal; ii) a WP at 0.6 Ib ai/100 gal; iii) a D at 4 Ib ai/A; iv) the 40% WP at 4 Ib ai/A by high-
volume ground equipment; and v) the 40% WP at 2.8 Ib ai/A by aircraft and low-volume ground equipment (each in
separate tests). Tests must be conducted in California or Oregon, Michigan, and Washington.
Residue data are also required to support SLN registrations. The data must reflect diazinon residues of concern
in or on cherry samples 10 days after i) the last of multiple foliar applications of the 50% WP formulation at 2
Ib ai/A applied by aircraft in no less than 10 gal/A, and by ground in no less than 100 gal/A; and ii) three
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
applications 14 days apart of a 4 Ib/gal EC or 48% EC formulation at 5 Ib ai/A in 130 gal applied by ground as a
soil drench in addition to the treatments described above. In the case of the 50% WP, the registrant must propose
a maximum number of applications or a maximum seasonal use rate for the label, the required data must be produced
using these maximums, and revised labeling must be submitted that specifies the maximum number of applications and
the interval between these applications. All tests must be conducted in California. Alternatively the registrant
may request voluntary cancellation of SEN Registration Nbs. CA-810043, CA-830009, and CA-830017, which permit
these uses in California.
58/ Residue data are required to determine diazinon residues of concern in or on nectarine samples 10 days following
the last of multiple foliar applications with the following formulations (each in separate tests); i) a D at 4
Ib ai/A; ii) the 40% WP at 4 Ib ai/A applied by high-volume ground equipment, and, in separate tests, at 2.8 Ib
ai/A applied by aircraft; and iii) an EC at 0.5 Ib ai/100 gal. The registrant must propose a maximum seasonal use
rate or a maximum number of applications per season for the label, and the required data must be produced using
these maximums. Tests must be conducted in California.
Residue data are also required to support SLN registrations. Residue data are required to determine diazinon
^> residues of concern in or on nectarine samples receiving the following applications: i) a single application of
°° the 14% G formulation at 2.8 Ib ai/A applied both by ground and aircraft in separate tests; ii) multiple foliar
applications of the 50 WP formulation at 2 Ib ai/A applied by aircraft in no less than 10 gal/A, and in separate
tests, by ground in no less than 100 gal/A; iii) three foliar applications 14 days apart of a 4 EC or 48% EC
formulation at 5 Ib ai/A in 130 gallons applied by ground as a soil drench; and iv) the treatments noted above.
In the case of ii) the registrant must propose a maximum number of application so or a maximum seasonal use rate
for the label, the required data must be produced using these maximums, and revised labeling must be submitted
that specifies the maximum number of applications and the interval between these applications. Tests must be
conducted in California. Alternatively, the registrant may request voluntary cancellation of SLN Registration
Nos. CA-810043, CA-830009, and CA-830017, which permit these uses in California.
5_9/ Residue data are required to determine diazinon residues of concern in or on peaches harvested 20 days after the
last of multiple seasonal foliar applications with the following formulations (each in separate tests), by both
air and ground application (in separate tests): i) the D formulation at 4 Ib ai/A; ii) the EC formulation at both
0.5 Ib ai/100 gal; and iii) the 40% WP formulation at both 2.8 1±> ai/A applied by aircraft, and 4 Ib ai/A applied
by high-volume ground equipment in separate tests. Samples must be collected 20 days after the last treatment.
The registrant must propose a maximum seasonal use rate or a maximum number of applications per season for the
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
5158.240 Residue Chemistry Footnotes (cont'd)
label, and the required data must be produced using these maximums. Tests should be conducted in California,
South Carolina, and Georgia.
Residue data are also required to support California SLN registrations. The data must identify residues of
concern in or on peach samples after the above-noted treatments, plus the following applications: i) the 14% G
formulation applied once at 2.8 Ib ai/A by ground and aircraft in separate tests; ii) multiple foliar applica-
tions of the 50% WP formulation at 2 Ib ai/A applied by aircraft in no less than 10 gal/A, and by ground in no
less than 100 gal/A in separate tests; and iii) three applications (14 days apart) of a 4 Ib/gal EC or 48% EC
formulation at 5 Ib ai/A in 130 gal applied by ground as a soil drench. In the case of ii), the registrant must
propose a maximum number of applications or a maximum seasonal use rate for the label, the maximum number of
applications and the interval between these applications. All tests must be conducted in California.
Alternatively, the registrant may request voluntary cancellation of SLN Registration Nos. CA-810043, CA-830009,
and CA-830017, which permit these uses in California.
60/ Residue data are required to determine diazinon residues of concern in or on on plums and fresh prunes following
multiple foliar applications with the following formulations, each in separate tests: i) a D at 4 Ib ai/A; ii) an
EC at 0.5 Ib ai/100 gal; and iii) the 40% WP applied by aircraft at 2.8 Ib ai/A, and by high-volume ground
equipment at 4 Ib ai/A (each in separate tests). Samples must be collected 10 days after the last treatment. The
registrant must propose a maximum number of applications per season, or a maximum seasonal rate per acre for the
label, and the require data must be produced using these maximums. Tests must be conducted in California.
Residue data are required to support California SLN registrations. The data must identify residues of concern in
or on plum samples harvested 10 days after the following applications, in addition to those noted above: i) the
14% G formulation applied once at 2.8 Ib ai/A both by ground equipment and aircraft in separate tests; ii)
multiple foliar applications of the 50% WP formulation at 2 Ib ai/A applied by aircraft, in no less than 10 gal/A,
and by ground equipment, in separate tests, in no less than 100 gal/A; and iii) three applications (14 days apart)
of a 4 ib/gal EC or 48% EC formulation at 5 Ib ai/A in 130 gal, applied by ground as a soil drench. In the case
of (ii), the registrant must propose a maximum number of applications or a maximum seasonal use rate for the
label, the required data must be produced using these maximums, and revised labeling must be submitted which
specifies the maximum number of applications and the interval between these applications. All tests must be
conducted in California. Alternatively, the registrant may request voluntary cancellation of SLN Registration
Nos. CA-810043, CA-830009, and CA-830017, which permit these uses in California.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
5158.240 Residue Chemistry Footnotes (cont'd)
6l/ Residue data are required to determine diazinon residues of concern in or on dried prunes processed from plums
bearing measurable weathered residues. If concentration of residues occurs during processing, an appropriate
food/feed additive tolerance must be proposed.
62/ Residue data are required to determine diazinon residues of concern in or on blackberries. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and
either a) request a determination of the specific formulations, rates, and application schedule to be tested on
blackberries; or b) indicate support of the use on raspberries and request that the required data for that use
pattern be used to support the use on blackberries.
63/ Residue data are required to determine diazinon residues in or on blueberries 7 days following the last of
multiple foliar applications of the EC, WP, and D formulations (one test for each) a 1 Ib ai/A. The registrant
must propose a maximum seasonal use rate, or a maximum number of applications per season, for the label, and the
required data must be produced using these maximums. Tests must be conducted in Michigan and New Jersey.
6>4/ Residue data are required to determine diazinon residues of concern in or on boysenberries. The registrant must
contact the Agency within the allowed ninety (90) day period for indicating intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be tested on
boysenberries; or b) indicate support of the use on raspberries and request that the required data for that use
pattern be used to support the use of boysenberries.
65/ Tests depicting diazinon residues of concern in or on cranberries 7 days following the last of multiple foliar
applications with both an EC and a WP formulation (a separate test for each) at 3 Ib ai/A in 400 gal/A. The
registrant must propose a maximum seasonal use rate, or a maximum number of applications per season, for the
label, the required data must be produced using these maximums. Tests must be conducted both in Massachusetts and
Wisconsin.
Residue data are also required to support SLN registrations. Tests depicting diazinon residues of concern in or
on cranberries harvested 7 days following the last of a treatment series that includes: i) foliar use of the EC
and WP formulations as detailed above; AND ii) two broadcast applications, 7 to 10 days apart, of the 14% G
formulation at 21 Ib ai/A/application. Tests must be conducted in Massachusetts, New Jersey, and Oregon.
Alternatively, the registrant may request voluntary cancellation of SLN Registration Nos. MA-830005, MA-850001,
MA-850002, NJ-840011, and OR-790056, which permit the use of 14% G diazinon on cranberries.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
667 Residue data are required to determine diazinon residues of concern in or on dewberries. The registrant must
contact the Agency within the allowed ninety (90) day period for indicating intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be tested on
dewberries; or b) indicate support of the use on raspberries and request that the required data for that use
pattern be used to support the use on dewberries.
677 Residue data are required to determine diazinon residues in or on grapes 10 days following the last of multiple
with the same interval requirements must be provided for EC and WP formulations (each in separate tests) applied
with a wetting agent, and for the D formulation applied by aerial equipment. Separate tests must be conducted at
0.56 Ib ai/A and a PHI of 1 days. The registrant must propose a maximum seasonal use rate, or a maximum number of
applications per season, for the label, and the required data must be produced using these maximums. Tests should
be conducted in California.
68/ Residue data are required to determine diazinon residues in raisins, raisin waste, dry pomace, and grape juice
processed from grapes bearing measurable weathered residues. Exaggerated rates may be necessary to obtain
sufficient residues on the RAC. If the residues concentrate in any of these processed commodities, appropriate
food/feed additive tolerances must be proposed.
697 Residue data are required to determine diazinon residues of concern in or on loganberries. The registrant must
contact the Agency within the allowed ninety (90) day period for indicating intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be tested on
loganberries; or b) indicate support of the use on raspberries and request that the required data for that use
pattern be used to support the use on loganberries.
2Q/ Residue data are required to determine diazinon residues of concern in or on raspberries receiving multiple foliar
applications of a WP, and in separate an EC at 1 Ib ai/A. The registrant must propose a maximum seasonal use
rate, or a maximum number of applications per season, for the label, and the required data must be produced using
these maximums. Tests must reflect a 7-day PHI, and must be conducted in Oregon and Washington.
Revised labeling must be submitted that specifies the total number of applications permitted per season and the
interval between these applications.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
2l/ Residue data are required to determine diazinon residues of concern in or on nature strawberries harvested 5 days
following the last of multiple foliar applications with a D formulation at 1.2 Ib ai/A and the EC and WP formula-
tions at 1 Ib ai/A (separate tests for each). The registrant must propose a maximum seasonal use rate, or a
maximum number of applications per season, for the label, and the required data must be produced using these
maximums. Tests should be conducted in California.
22/ Residue data are required to determine diazinon residues of concern in or on almonds (nutmeats and hulls)
resulting from the following full-season application schedule: i) multiple foliar applications of (in separate
tests) a WP formulation at 2.8 Ib ai/A using aircraft or low-volume ground equipment, in separate tests, a WP at 4
Ib ai/A using high-volume ground equipment, an EC at 0.8 Ib ai/100 gal (applied by ground and, in separate tests,
by air), and a D formulation at 6 Ib ai/A (applied by ground and aerial equipment in separate tests); and ii)
dormant application (each in separate tests) of a WP formulation at 2.8 Ib ai/A using aircraft or low-volume
ground equipment (in separate tests), a WP at 4 Ib ai/A using high volume ground equipment, and an EC formulation
at 0.86 Ib ai/gal (by ground and air in separate tests); and iii) multiple soil drench applications (at 14-day
intervals) of an EC at 5 Ib ai/A. The registrant must propose a maximum seasonal use rate for foliar applications
for the label, and the required data must be produced using these maximums. Tests must be conducted in
California.
23/ Residue data are required to determine diazinon residues of concern in or on filberts harvested on the day of the
last of a series of multiple foliar applications (ending prior to husk split) of a WP and EC formulation (each in
separate tests) at 2 Ib ai/A, and a D formulation at 1.5 Ib ai/A. Separate tests should reflect ground and aerial
application of each formulation. These studies must be conducted in Oregon. A separate set of tests (to be
conducted in California) must include multiple soil drench treatments with an EC formulation at 5 Ib ai/A at 14-
day intervals. The registrant must propose a maximum seasonal use rate for the label, and the required data must
be produced using these maximums.
74/ Residue data are required to determine diazinon residues of concern in or on pecans receiving the following full-
season application schedule: i) multiple foliar applications (by ground and air in separate tests) of a WP and an
EC formulation (each in separate tests) at 3 Ib ai/A, and (in separate tests), of a D formulation at a maximum
rate which must be proposed by the registrant; and ii) multiple soil drench applications of a 4% EC formulation at
5 Ib ai/A, to be repeated at 14-day intervals. Tests must incorporate a 0-day PHI. The registrant must propose a
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
maximum seasonal use rate, or a maximum number of foliar applications per season, for the label, and the required
data must be produced using these maximums. These studies must be conducted in Georgia, Texas, New Mexico, and
Alabama.
25/ Residue data are required to determine diazinon residues of concern in or on walnuts receiving the following full-
season application schedule: i) multiple dormant applications of the 0.33 Ib/gal EC at 2.6 Ib ai/200 gal/A; ii)
multiple foliar applications (by ground, and in separate tests, by aerial equipment) of, in separate tests, a WP
at 3 Ib ai/A, an EC at 3 Ib ai/A, and a D at 5 Ib ai/A; and iii) multiple soil drench applications of an EC
formulation at 5 Ib ai/A, repeated at 14-day intervals. These studies must incorporate a 0-day PHI. The
registrant must propose a maximum number of foliar applications per season for the label, and the required data
must be produced using these maximums. Studies must be conducted in California.
26/ Residue data are required to determine diazinon residues of concern in or on field corn and in or on sweet com
(kernels plus cob with husks removed) from tests reflecting the following full-season application schedule: i)
preplant broadcast soil application of a G, WP, and EC formulation (each in separate tests), at 10 Ib ai/A; ii)
soil application of a G formulation at 2 Ib ai/A, and a WP formulation at 2.5 oz/1000 ft of row, to be applied in
a minimum of 5 gal water/A; iii) seed treatment application of a D and WP formulation (each in separate tests) at
_. 1.67 oz/bu; and iv) multiple foliar applications of WP and EC formulation at 1.25 Ib ai/A, and a G formulation at
S 2 Ib ai/A (each in separate tests). In additional tests, com samples must be harvested 10 days following the
last of a series of foliar applications of a D formulation at 2 Ib ai/A. Foliar applications must be made using
ground equipment, and in separate tests, aerial equipment. The registrant must propose a maximum number of soil
and foliar applications per season, and the required data must be produced using these maximums. Field corn tests
must be conducted in Iowa, Illinois, Nebraska, Minnesota, Indiana, Ohio, and Wisconsin. Sweet com tests must be
conducted in Wisconsin, Washington, Oregon, Minnesota, and New York.
22/ Residue must be determined in crude and refined oil and milling products processed from field corn grain bearing
measurable weathered residues. If residues are found to concentrate in any of these processed products,
appropriate food/feed additive tolerances must be proposed.
28/ Residues data are required to determine diazinon residues of concern in or on sorghum grain resulting from the
following full-season application schedule: i) preplant broadcast soil application of a G, WP, and EC formulation
(each in separate tests) at 4 Ib ai/A; ii) soil application of a G formulation at 2 Ib ai/A at-planting or
emergency (band); and iii) multiple foliar applications (by ground and, in separate tests, aerial equipment), of a
W and EC formulation (each in separate tests) at 0.5 Ib ai/A. Samples must be collected 7 days after the last
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
application. Aerial applications must be made in a minimum of 1 gal water/A and ground applications must be made
in a minimum of 5 gal water/A. The registrant must propose a maximum number of applications per season for the
label, and the required data must be produced using these maximums. Tests must be conducted in Texas, Kansas,
Nebraska, and Missouri.
127 The milling study required for wheat will be translated to sorghum in order to determine whether food/feed
additive tolerances will be needed for sorghum milling products.
80/ While there are no FIFRA section 3 registrations for use of diazinon in or on wheat, residue data are required to
support SLN registrations. Residue data are required to determine diazinon residues of concern in or on wheat
grain harvested after a single preplant broadcast soil application with the 4 Ib/gal EC and the 14% G formulations
at 2 Ib ai/A, in separate tests. Tests must be conducted in Kansas, Montana, or North Dakota, and Texas or
Oklahoma. Alternatively, the registrant may request voluntary cancellation of SLN Registrations Nos. KS-820018 (4
Ib/gal EC), KS-820019 (14% G) , OK-820005 (14% G), OK-830001 (14% G), and TX-820057 (4 Ib/gal EC) which permit
these uses.
Residues data are also required to determine diazinon residues of concern in or on wheat grain harvested after a
single preplant broadcast soil application with the 50% WP formulation at 2 Ib ai/A. This test must be conducted
in Kansas. Alternatively, the registrant may request voluntary cancellation of SLN Registration No. KS-820017,
which permits this use.
81/ A wheat milling study using grain bearing measurable weathered residues of diazinon is required. If residues are
found to concentrate in any milling fraction, appropriate food/feed additive tolerances must be proposed.
82/ Additional residue data are required to support the established tolerances for corn forage and sorghum forage. A
tolerance proposal must be submitted (and appropriate residue data provide) for corn fodder and forage and either
sorghum fodder and forage, or wheat forage, hay, and straw.
83/ Residue data are required to determine diazinon residues of concern in or on sweet corn forage and corn fodder
from tests using the following full-season application schedule: i) preplant broadcast soil application of a G, a
WP, and an EC formulation (each in separate tests), at 10 Ib ai/A; ii) soil application of a G formulation at 2 Ib
ai/A, and a WP formulation at 2.5 oz/1000 ft of row, to be applied in a minimum of 5 gal water/A; iii) seed
treatment application of a D and WP formulation (each in separate tests) at 1.67 oz/bu; and iv) multiple foliar
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
applications of a WP and an EC formulation at 1.25 Ib ai/A, and a G formulation at 2 Ib ai/A (each, in separate
tests). In additional tests, corn samples must be harvested 10 days following the last of a series of foliar
applications of a D formulation at 2 Ib ai/A. Foliar applications must be made using ground equipment, and in
separate tests, aerial equipment. Sweet corn tests must be conducted in Wisconsin, Washington, Oregon, Minnesota,
and New York. The registrant must propose a maximum number of soil and foliar applications per season for the
label, and the required data must be produced using these maximums.
Revised labeling must be submitted that specifies the total number of applications permitted per season and the
interval between these applications.
£4/ Residue data are required to determine diazinon residues of concern in or on sorghum fodder and forage resulting
from the following full-season application schedule: i) preplant broadcast soil application of a G, WP, and EC
formulation (each in separate tests) at 4 Ib ai/A; ii) soil applications of a G formulation at 2 Ib ai/A at
planting or emergence (band); and iii) multiple foliar applications (by ground and in separate tests, aerial
equipment), of a WP and EC formulation (each in separate tests) at 0.5 Ib ai/A. Required tests must incorporate a
7-day PHI. Aerial applications must be made in a minimum of 1 gal water/A and ground applications must be made in
a minimum of 5 gal water/A. Tests must be conducted in Texas, Kansas, Nebraska, and Missouri. The registrant
^ must propose a maximum number of applications, or maximum seasonal use rate, for the label, and the required data
o must be produced using these maximums. Furthermore, tolerances must be proposed and/or appropriate data submitted
01 for fodder and forage, since both are RACs of sorghum. Alternatively, the registrant may propose feeding and
grazing restrictions.
85/ Residue data are required to determine diazinon residues of concern in or on wheat forage and straw after a single
preplant broadcast application with the 50% WP formulation at 2 Ib ai/A. This test must be conducted in Kansas.
Alternatively, the registrant may request voluntary cancellation of SEN Registration No. KS-820017, which permits
this use. Available data do indicate, however, that the SLN registrations of the 4 Ib/gal EC and 14% G formula-
tions will not result in residues exceeding the established 0.05 ppm tolerance for diazinon residues in or on
wheat forage or straw.
j86/ A tolerance of 60 ppm (not more than 40 ppm 24 hours after application) has been established for residues of
diazinon per se in or on grass forage. A tolerance of 10 ppm has been established for residues in or on grass
hay. However, additional data are required to fully support this group tolerance.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
Residue data are required to determine diazinon residues of concern in or on each of the representative
commodities (Bermuda grass, bromegrass or fescue, and bluegrass) treated, in separate tests, with all appropriate
formulations under the maximum registered use and employing a 0-day PHI for grass. Data for grass hay should
reflect presently registered minimum FHI's. Tests must be performed using ground and, in separate tests, aerial
equipment. The registrant must propose a maximum seasonal foliar use rate for the label, and the required data
must be produced using these maximums. Tests should be performed in California, Iowa, Michigan, Minnesota,
Nebraska, New York, Pennsylvania, Washington, and Wisconsin.
Revised labeling must be submitted that specifies the total number of applications permitted per season and the
interval between these applications.
Residue data are required to determine diazinon residues in or on Bermuda grass, bluegrass, and bromegrass (or
fescue) treated at the maximum use rate and number of applications using the appropriate formulations registered
under all of the SEN registrations for Florida, California, and Oregon, and employing a 0-day PHI for grass. Data
for grass hay should incorporate presently registered minimum PHI'S for each SLN registration. Applications
should be made using ground/aerial equipment (separate tests) if appropriate. The registrant must propose a
maximum seasonal use rate, or a maximum number of applications per season, for the SLN labels for Florida and
Oregon, the required data must be produced using these maximums, and revised labeling must be submitted that
specifies the total number of applications and the interval betweens these applications. Alternatively, the
registrant may request voluntary cancellation of SLN Registration Nos. CA-800056, FL-790003, and OR-800062 which
permit these uses.
Residue data are required to determine diazinon residues of concern in or on Oregon grown orchardgrass harvested
at the usual time following broadcast applications of the 14% G during April at 3.5 Ib ai/A. Application must be
made by aerial and, in separate tests, ground equipment. Residue tests should be performed on grass and hay. The
registrant must propose a maximum seasonal use rate, or a maximum number of applications per season for the label,
and the required data must be produced using these maximums. Revised labeling must be submitted that specifies
the total number of applications permitted per season and the interval between these applications.
82/ Residue data are required to determine diazinon residues of concern in or on alfalfa treated with multiple foliar
applications of the following formulations, and harvested in the following manner: i) an EC and WP (a separate
test for each) at 0.5 Ib ai/A, harvested as forage 0 days posttreatment; ii) an EC and WP at 1.5 Ib ai/A,
harvested as forage 2 days posttreatment; iii) a D formulation at 0.6 Ib ai/A, harvested as forage 7 days
posttreatment; iv) an EC, a D, and a WP (each in separate tests) at 0.5 Ib ai/A, harvested as green hay 7 days
-------
Generic Data Requirements for Diazinon (cont'd)
§158.240 Residue Chemistry Footnotes (cont'd)
post treatment and analyzed as field-cured hay (90% dry matter) ; and v) a D at 0.6 Ib ai/A and an EC and a WP at
1.5 Ib ai/A (a separate test for each), harvested as green hay 10 days post-treatment and analyzed as field-
cured hay (90% dry matter). All treated test plots should have one preplant broadcast soil application of the G,
EC, or WP formulation at 4 Ib ai/A (a separate test performed for each formulation). The registrant must propose
a maximum number of foliar applications per season for each use (hay and forage), or propose a maximum seasonal
foliar use rate, for the label, and the required data must be produced using these maximums. Foliar application
must be performed by aerial and in separate tests, ground equipment. Tests must be conducted in California,
Idaho, Iowa, Kansas, Minnesota, Nbntana, Nebraska, New York, North Dakota, South Dakota, and Wisconsin.
88/ Residue data are required to determine diazinon residues of concern in or on birdsfood trefoil harvested at a
suitable post-treatment interval, to be proposed by the registrant, following a preplant broadcast soil incor-
poration with the 50% WP formulation at 8 Ib ai/A. Tests should be conducted in Georgia, Kentucky, Missouri,
New York, Ohio, Oklahoma, Pennsylvania, Tennessee, and Texas. If the registrant supports the use of diazinon on
alfalfa, then he may request that all the other data required to support the use on birdsfoot trefoil be
translated from the required data on alfalfa.
£9/ Residue data are required to determine diazinon residues of concern in or on clover treated with multiple foliar
applications of the following formulations, and harvested in the following manner: i) an EC and a WP (separate
test for each) at 0.5 Ib ai/A, harvested as forage 0 days posttreatment; ii) an EC and WP at 1.5 Ib ai/A,
harvested as forage 2 days posttreatment; iii) a D formulation at 0.6 Ib ai/A, harvested as forage 7 days post
-treatment; iv) an EC, a D, and a WP at 0.5 Ib ai/A, harvested as green hay 7 days posttreatment (a separate test
for each formulation) and analyzed as field-cured dried hay (90% dry matter); and v) a D at 0.6 Ib ai/A and an EC
and a WP at 1.5 Ib ai/A (a separate test for each), harvested as green hay 10 days posttreatment and analyzed as
field-cured hay (90% dry matter). All treated test plots should have one preplant broadcast soil application of
the G, EC, or WP formulation at 4 Ib ai/A (a separate test performed for each formulation). The registrant must
propose a maximum number of foliar application per season for each use (hay and forage, low rate, and high rate),
or propose a maximum seasonal foliar use rate, for the label, and the required data must be produced using these
maximums. Foliar applications must be performed by both air and ground equipment (in separate tests). Tests must
be conducted in Arkansas, Iowa, Kentucky, Missouri, New York, Oklahoma, Pennsylvania, Tennessee, Texas, and
Virginia.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
907 Residue data are required to determine diazinon residues of concern in or on lespedeza. The registrant must
contact the Agency within the allowed ninety (90) day period for indicating intention to support this use, and
either: a) request determination of the specific formulations, rates, and application schedule to be tested on
lespedeza; or b) indicate support of the use of alfalfa and clover and request that the required data for those
use patterns be used to support the use on lespedeza.
91/ Residue data are required to determine diazinon residues of concern in or on bananas receiving the following full-
season application schedule: i) four soil applications (at 28-day intervals) of a G at 2 Ib ai/A, using ground
equipment; and ii) stem treatment with a G formulation at 1 g/stem. Tests must be conducted in Hawaii.
Residue data are also required to support SLM registrations. Residue data are required to determine diazinon
residues of concern in or on bananas receiving the following full-season application schedule: multiple foliar
applications of an EC and, in separate tests, a WP at 0.5 Ib ai/A (applied by ground and air in separate tests).
Tests must incorporate a 7-day PHI for foliar applications. The registrant must propose a maximum number of
treatments, or use rate per season, for foliar treatments for the SLN labels, and the required data must be
produced using these maximums. Tests must be conducted in Hawaii. Alternatively, the registrant may request
o voluntary cancellation of SLN Registration Nos. HI-760003 and HI-760004 which permit these uses.
00
927 Residues of concern must be determined in roasted beans and instant coffee produced from beans bearing measurable
weathered residues. If residues concentrate in either of these processed products, appropriate food additive
tolerances must be proposed.
93/ Residue data are required to determine diazinon residues of concern in or on cottonseed and cotton forage
harvested 14 days after multiple foliar applications of a WP, an EC, and a D formulation (each in separate tests)
at 1 Ib ai/A, 1 Ib ai/A, and 1.2 Ib ai/A, respectively. All field trials must include ground and aerial
application (in separate tests). The registrant must propose a maximum seasonal application rate or a maximum
number of applications per season for the label, and the required data must be produced using these maximums.
Tests must be conducted in California, Mississippi, and Texas.
94/ The registrant must submit data depicting diazinon residues of concern in soapstock processed from cottonseed
bearing measurable weathered residues. If concentration is found to occur during processing, an appropriate
tolerance must be proposed.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
5158.240 Residue Chemistry Footnotes (cont'd)
957 Residue data are required to determine diazinon residues of concern in or on figs, resulting from the following
treatment schedule: multiple foliar applications, by aerial and ground equipment in separate tests, of a D
formulation at 2.4 l ai/A, a WP at 2.8 Ib ai/A by air and ground (in separate tests). Tests must incorporate a 5-
day PHI when foliar use rates are not above 2.4 Ib ai/A, and a 10-day PHI where use rates are higher. The
registrant must propose a maximum seasonal application rate, or a maximum number of applications per season, for
the label, and the required data must be produced using these maximums. Tests must be conducted in California.
Revised labeling must be submitted that specifies the total number of applications permitted per season and the
interval between these applications.
Residue data are also required to support SLN registrations. Residue data are required to determine diazinon
residues of concern in or on figs, resulting from the following treatment schedule: multiple soil drench
applications of an EC formulation at 5 Ib ai/A (in 130 gal water/A) at 14-day intervals. Tests must incorporate
either a 0-day PHI for soil treatment, or an alternate PHI proposed by the registrant for this use. The
registrant must propose a maximum seasonal application rate or a maximum number of applications per season for the
SEN label, the required data must be produced using these maximums, and revised SLN labeling must be submitted
which specifies the total number of applications permitted per season and the interval between these applications,
as well as the PHI supported by the soil drench tests. Tests must be conducted in California. Alternatively, the
registrant may request voluntary cancellation of SLN registration CA-830017 which permits this use.
96/ Data indicating whether diazinon residues of concern concentrate during drying of fresh figs bearing measurable
weathered residues is required. If concentration occurs, an appropriate food additive tolerance for residues of
concern in dried figs must be proposed.
97/ Residue data are required to determine residues of concern in or on hops harvested 14 days following the last of
multiple foliar applications of a D formulation at 2 Ib ai/A; and (in separate tests) a WP and an EC (each in
separate tests) at 1 Ib ai/A. Separate tests must be conducted using ground and aerial equipment. The registrant
must propose a maximum seasonal application rate or a maximum number of applications per season for the label, and
the required data must be produced using these maximums. Tests must be conducted in Oregon and Washington.
98/ Residues must be determined in dried hops processed from hops bearing measurable residues. If residues are found
to concentrate in dried hops, appropriate food/feed additive tolerances must be proposed for dried and spent hops.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
99/ Residue data are required to determine diazinon residues of concern in or on kiwifruit, resulting from multiple
foliar (ground) applications of the 50% WP formulation at 0.5 Ib ai/A. The registrant must propose a maximum
seasonal application rate or a maximum number of applications per season for the label, and the required data must
be produced using these maximums. Tests must be conducted in California and must reflect the established 1-year
prefruit-set interval.
10Q/ Residue data are required to determine diazinon residues of concern in or on mushrooms grown in mushroom houses on
which premise treatments have been made using a WP and (in separate tests) an EC at 1% concentrations in the
finished spray. Studies must be conducted in Pennsylvania and California.
Residue data are required to support the SLN registrations. Residue data are required to determine diazinon
residues of concern in or on mushrooms following treatment of compost (prior to spawning) with a WP formulation at
the maximum rate. Alternatively, the registrant may request voluntary cancellation of SLN Registration Nos. CA-
800087, DE-790022, OR-800090, PA-790013, PA-810002, and PA-810007 which permit this use.
101/ Residue data are required to determine diazinon residues of concern in or on olives harvested after the following
treatments: i) several multiple foliar applications of WP and EC formulations (each in separate tests) at 0.5 Ib
ai/100 gal; and the 40% WP (in separate tests) at 3.2 Ib ai/A. Separate tests must be conducted using ground and
aerial equipment; ii) multiple soil drench application of a 4 Ib/gal EC at 5 Ib ai/A. The registrant must propose
a maximum seasonal application rate or a treatment numbers for foliar or soil treatments for the label, and the
required data must be produced using these maximums. Tests must be conducted in California.
1027 No tolerance has been established or proposed for residues of diazinon in olive oil processed from diazinon-
treated olives. Since submitted studies indicate that residue concentration occurs during processing of olives to
produce oil, the registrant must submit an acceptable olive processing study and propose a food additive tolerance
for residues in olive oil.
103/ Residue data are required to determine diazinon residues of concern in or on peanuts, peanut hulls, and peanut
forage and hay, resulting from the following application schedule: i) four soil band applications of a G, a WP,
and an EC (each in separate tests) at 2 Ib ai/A; and ii) one broadcast or band (separate tests) soil application
of a G at 43 Ib ai/A, applied immediately prior to pegging. These tests must incorporate a 21-day PHI for nuts
and hay, and a 7-day PHI for hulls and forage. Field trials must be conducted in Georgia, Texas, and North
Carolina.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
1047 Residue data are required to determine diazinon residues of concern in meal, crude oil, refined oil, and soapstock
derived from pea nuts bearing measurable weathered residues. If concentration of residues occurs during
processing, the registrant must propose food/feed tolerances and submit appropriate residue data.
1057 Residue data are required to determine residues of concern in or on pineapples receiving the following full-season
application schedule: i) multiple foliar applications of an EC and, in separate tests, a WP at 2 Ib ai/A; ii)
postharvest application(s) of a WP (and in separate tests) an EC formulation at 5 Ib ai/500 gal/A; and iii)
postharvest dip application of the 47.5% EC formulation at 2 Ib ai/100 gal of water. Tests must be conducted
using ground and aerial equipment. The registrant must propose a maximum seasonal use rate or application numbers
for foliar and postharvest (vegetative slip) treatments for the label, and the required data must be produced
using these maximums and must incorporate a 7-day PHI. Tests must be conducted in Hawaii.
1067 Residues must be determined in pineapple juice and bran processed from pineapples bearing measurable residues. If
residues are found to concentrate in either of these processed products, an appropriate food/feed additive
tolerance must be proposed.
1077 Residue data are required to determine diazinon residues of concern in or on sugarcane resulting from the
following full-season application schedule: i) preplant broadcast soil application of a 10% G formulation at 3 Ib
ai/A; ii) four broadcast soil applications of a G formulation at 2.5 Ib ai/A; iii) in-furrow soil (band)
application of a G formulation at 6 Ib ai/A, a WP at 4 Ib ai/A and an EC at 4 Ib ai/A (each in separate tests) ;
and iv) multiple foliar applications of a WP and an EC (each in separate tests) at 0.5 Ib ai/A. Separate tests
must use ground and aerial equipment for foliar and soil broadcast applications. The registrant must propose a
maximum seasonal use rate or maximum number of foliar applications per season for the label, and the required data
must be produced using these maximums and must incorporate a 1-day PHI. Tests must be conducted in Florida,
Hawaii, and Louisiana.
108/ Processing data for molasses, refined sugar, and bagasse, to determine the concentration of residues upon
processing. These data must be generated from sugarcane bearing measurable weathered residues. If residues are
found to concentrate in any of these commodities, appropriate food/feed additive tolerances must be proposed.
109/ All significant tobacco plant metabolites must be determine using ring-labeled [14C] diazinon. These compounds
must be analyzed for the required residue studies listed below. Any significant translocated degradation products
from soil and photodegradation products must also be determined.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
5158.240 Residue Chemistry Footnotes (cont'd)
Data depicting residues of concern in or on tobacco resulting from the following full-season application schedule:
i) preplant broadcast soil application of a G, a WP, an EC, and a D formulation (each in separate tests) at 3 Ib
ai/A; ii) at-plant or at-transplant soil application of a D formulation at 1.05 Ib ai/A; iii) transplant water
application of a WP and EC formulation (each in separate tests) at 0.5 Ib ai/100/100 sq yd; and iv) multiple
foliar applications of a WP and an EC formulation (each in separate tests) at 0.5 Ib ai/A, and a D formulation at
equipment. The tests should be conducted in North Carolina, Kentucky, Tennessee, and South Carolina. The
registrant must propose a maximum seasonal use rate or maximum number of foliar and preplant broadcast soil
applications per season for the label, and the required data must be produced using these maximums. Residue data
are required for both green and cured tobacco, and for tobacco smoke. If total residues found in or on tobacco
from the above-required studies are greater than 0.1 ppm, then: i) complete analytical methods must be submitted
for detecting and quantifying diazinon and all metabolites of concern in or on tobacco and in tobacco smoke; and
ii) pyrolysis products from diazinon must be characterized using ring-labeled [14C] diazinon.
HO/ Residue data depicting diazinon residues of concern in or on watercress 5 days following the last of multiple
foliar applications of an EC and a WP (in separate tests) at 0.5 Ib ai/A. These tests must be performed in
Hawaii. The registrant must propose a maximum seasonal foliar use rate or maximum number of foliar applications
per season for the label, and the required data must be produced using these maximums.
Residue data are required to support the SLN registrations. Residue data depicting diazinon residues of concern
in or on watercress 10 days following multiple foliar applications of a 50% WP formulation at 0.5 Ib ai/A. The
registrant must propose a maximum seasonal foliar use rate, or maximum number of applications per season, for the
label, and the required data must be produced using these maxunums. The tests must be done in Florida,
California, and Hawaii. Revised SLN labeling must be submitted that specifies the total number of foliar
applications permitted per season and the interval between these applications. Alternatively, the registrant may
request voluntary cancellation of SLN registrations AL-820005, FL-820004, MD-820006, and PA-810025 which permeates
of a 50% WP formulation on watercress at 0.5 Ib ai/A with a 10-day PHI.
Ill/ Presently, the nature of the residue in ruminants (including milk) and in poultry (including eggs) is not
adequately understood. Furthermore, additional residue data are required for the RACs and processed products
comprising animal feeds. Therefore, the adequacy of the established tolerances cannot be assessed as this time.
Upon fulfillment of the data requirements under Nature of the Residue in Animals, Storage Stability Data, and
Magnitude of the Residue in Plants, the adequacy of the available data to support tolerances for residues in
animal products will be evaluated.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
1127 No data nave been submitted depicting residues of concern of diazinon in fish. If detectable residues of concern
are found in water from the registered aquatic food crop uses, then residue studies on fish employing diazinon in
water at levels which would be expected at the time of application are required.
1137 No data are available depicting the nature and magnitude of residues of diazinon in natural waters. The following
data are required:
- Depiction of the nature of the residue and the level of residues of concern in the water of treated areas at
regular intervals after application of a regimen of treatments represented a maximum use for watercress.
For watercress, multiple aerial and ground foliar applications at 10-day intervals of either an EC or a WP
formulation must be made at 0.5 Ib ai/A in 100 gal of spray suspension/A. Should detectable residues of concern
occur in water then the registrant must either propose an ARLDW (Accepted Residue Level in Drinking Water) and a
tolerance for residues from irrigation water in all crop groups, or propose restrictions in the registered uses
for watercress so that water potentially to be used for irrigation or drinking is not exposed.
1147 No numerical tolerances have been established covering residues of diazinon in foods resulting from treatment of
food-handling establishments. The available data are insufficient to evaluate the need for tolerances for
residues resulting from these uses because: i) no studies were conducted depicting residues resulting from
exaggerated exposure to diazinon by application of exaggerated rates, exposure of food in treated areas for longer
periods than might be normally expected, and leaving food exposed in the immediate vicinity when diazinon
applications are being made and ii) no tests were conducted depicting residues in or on foods resulting from the
registered treatments with a pressurized liquid or a pressurized microencapsulted formulation. Therefore, the
following additional data are required:
- Data depicting diazinon residues of concern in or on food resulting from applications of diazinon in a food
service establishment and a food-manufacturing establishment or a food-processing establishment. Test at
exaggerated rates are required for emulsifiable concentrates and dusts in these establishments and must
be designed to incorporate the concerns raised in item (i) above. The registrant must submit a protocol
within 90 days of receipt of this Registration Standard for this requirement. Tests are required in these
establishments utilizing a pressurized liquid or a pressurized microencapsulated formulation applied in a 1%
spray as a spot treatment covering 20% of the surface area (sprayed until completely wetted) of rooms of the
establishment where food products are held, processed, and served. The registrant must determine, from the
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
s158.240 Residue Chemistry Footnotes (cont'd)
above applications, residues of concern from direct deposition of spray droplets on food, volatili-zation, and
subsequent absorption by foods, and all other possible modes of exposure of foods and residue
transfer routes as outlined in the EPA Pesticide Assessment Guidelines, Subdivision 0, Residue Chemistry, 171-
4(0(5). Representative food samples must be examined for residues of concern from these possible modes of
exposure; the food must include an oily food (e.g., butter), baked cereal product, beverages, raw and processed
meats, and fresh fruits and vegetables (lettuce). The registrant may propose a maximum use rate per unit floor
area and apply the maximum Ib ai in the required tests. Tests must also include conditions of possible misuse
of diazinon and exaggerated exposure; e.g., applying an exaggerated rate or direct exposure of foods to the
diazinon spray applied (refer to EPA Pesticide Guidelines for details of the type of data required).
If residues of concern are found to occur in or on foods from the registered food-handling establishment premise
uses, then appropriate tolerances must be established.
115/ Study (ies) currently under review.
j,—,
j—i
Ui
-------
Table A
Generic Data Requirements for Diazinon
Data Requirement
Composition
Use
Patterns
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data^/
3(c)(2)(B)? Submission
S158.290 Environmental Fate
Degradation Studies - Lab
161-1 - Hydrolysis
Photodeoradation
161-2 - In Water
161-3 - On Soil
161-4 - In Air
Metabolism Studies - Lab
162-1 - Aerobic Soil
TGAI or PAIRA A,B,C,E, Partially
F,G,H,I
TGAI or PAIRA A,B,C,E, No
F,G,H
TGAI or PAIRA A,B,C,G, Yes
H
TGAI or PAIRA A
162-2 - Anaerobic Soil TGAI or PAIRA A
162-3 - Anaerobic Aquatic TGAI or PAIRA C,G
162-4 - Aerobic Aquatic TGAI or PAIRA C
No
TGAI or PAIRA A,B,E,F, Yes
G,H
Yes
Yes
No
00118021
YeslQ/
00153231,00153229 No
Reserved2-/
00118031,40028701 No
40028701
40101501
NO
No
Yes
9 Months
9 Months
27 Months
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Use
Data Reouirement Composition Patterns
§158.290 Environmental Fate
Mobility Studies
163-1 - Leaching and TGAI or PAIRA A
Adsorption/
Desorption
163-2 - Volatility (Lab) TEP A,E,F
163-3 - Volatility (Field) TEP A,E,F
Dissipation Studies - Field
164-1 - Soil TEP A,B,H
164-2 - Aquatic (Sediment) TEP C
164-3 - Forestry TEP G
164-4 - Combination and Tank TEP
164-5 - Soil, Long-Term TEP A,B,H
Does EPA
Have Data to
Satisfy This
Requirement?
Partially
No
No
No
No
NO
No
Most Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?
00118034,40512601 Yes^0-/
Reserved^/
Reserved5-/
Yes6-/
Yes
Yes
No2/
Timeframe
For Data
Submission
9 Months
27 Months
progress
report-6
months
27 Months
27 Months
-------
00
Table A
Generic Data Requirements for Diazinon (cont'd)
Use
Data Requirement Composition Patterns
5158.290 Environmental Fate
Accumulation Studies
165-1 - Rotational Crops PAIRA A,C
(Confined)
165-2 - Rotational Crops TEP A
(Field)
165-3 - Irrigated Crops TEP C
165-4 - In Fish TGAI or PAIRA A,B,C,G
165-5 - In Aquatic Non- TEP G
Does EPA
Have Data to
Satisfy This Bibliographic
Requirement? Citation
No
No
No
No
No
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Yes
Reserved^/
Yes
yeslQ/
Reserved9-/
Timeframe
For Data
Submission
39 Months
39 Months
12 Months
target Organisms
Special Study
small scale
prospective
ground water study
TEP
A,B,G
No
Reserved6-/
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.290 Eavironmental Fate Footnotes (cont'd)
a/ For those data requirements identified in the May 1987 Comprehensive Data Call-in, the operative due dates are those
stipulated in that document or as officially extended by the EPA in response to registrant's request. For any new
data requirement imposed by this Registration Standard, the operative due dates are those imposed under this
Registration Standard.
!/ Data are needed to characterize hydrolysis under sterile conditions.
2/ Reserved pending receipt and evaluation of the required studies on laboratory volatility (§158.290 163-2),
toxicology (§158.340), and reentry (§158.390).
3/ Aged soil column leaching study, with complete identification of degradates, is required.
4/ Reserved pending receipt and evaluation of the required studies on toxicology (§158.340) and reentry (§158.390).
5/ Reserved pending receipt and evaluation of the required study on laboratory volatility (§158.290 163-2).
6/ Field dissipation studies must include sampling to sufficient depths (i.e., where residues no longer persist), and a
two (2) feet residue free zone (nondetectable residues) must be established below the deepest point of residue
movement. Testing for the presence of diazinon, oxypyrimidine, and 2-(l-hydroxy 1-methyl)ethy 1-4-6-
hydroxypyrimidine is required at each sampling depth. The analytical method should be very sensitive, preferably at
the 10 ppb level, to assess the extent of leaching. Interim results of these studies must be submitted 6 months
after the studies are initiated for Agency assessment. A small-scale prospective ground water study under
conditions where leaching is most likely to be observed is required if residues are detected moving beyond a 3 feet
depth.
I/ Based on the laboratory aerobic and anaerobic soil metabolism data, a long-term field dissipation study will not be
needed.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
§158.290 Environmental Fate Footnotes (cont'd)
8/ Reserved pending receipt and evaluation of the required confined rotational crop study (§158.290 165-1).
2/ Reserved pending receipt and evaluation of tne required studies on laboratory fish accumulation (§158.290 165-4),
aquatic dissipation (§158.290 164-2, and aquatic organisms (§158.145 72).
1Q/ Study (ies) currently under review.
-------
Table A
Generic Data Requirements for
Data Recaii rement
Does ERA
Have Data to
Use Satisfy This
Composition Patterns Requirement?
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section for
Citation 3(c)(2)(B)? Submission
Sec. 158.390 Reentry Protection
132-1 - Foliar Dissipation TEP
132-2 - Soil Dissipation TEP
A,B,C,E,
F,G,H
Yes
NO
40202901,40202902 No
40202903,40466601.
NO
132-3 - Dermal Exposure
TEP
A,B,C,E, NO
F,G,H.
NO
132-4 - Inhalation Exposure TEP
Sec. 158.440 Spray Drift
201-1 - Droplet Size Spectrum TEP
A,B,C,E No
F,G,H.
A,B,C,D,G NO
NO
YesJU2/ 12 Months
(3 months protocol)
202-1 - Drift Field Evaluation
TEP
A,B,C,D,G NO
YesJU2-/ 12 Months
(3 months protocol)
I/ The spray drift droplet specturm and field evaluation may be done together in order to evaluate the drop spectrum
that are associated with actual field use patterns.
2/ A protocol must be submitted before attempting these studies. An acceptable protocol must be submitted within
ninety (90) days of receipt of this Registration Standard.
-------
Table A
Generic Data Requirements for Diazinon
K3
ro
Data
S158.
81-1
81-2
81-3
81-7
Requirement
340 Toxicology
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation
- Acute Delayed
Neurotoxicity
Composition
TGAI
TGAI
TGAI
TGAI
Does EPA
Have Data to
Satisfy This
Requirement?
Use (Yes, No or Bibliographic
Patterns Partially) Citation
All Yes 00146179
All Yes 00146180
All Yes 00109043
All No
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
No
No
No
Yes1'12/
Timeframe
For Data3/
Submission
12 Months
Subchronic Testing
82-1
82-2
82-3
- 90-Day Feeding
- Rodent
- Nonrodent
- 21-Day Dermal
- 90-Day Dermal
TGAI
TGAI
TGAI
TGAI
All NO
All NO
All-3/ NO
All^/ No
Yes2-!2/
Ycc2.127
Yes2^12/
Reserved^/
15 Months
18 Months
12 Months
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
NJ
LO
Data Requirement ComDOsition
S158.340 Toxicology
Subchronic Testing (cont'd)
82-4 - 21-Day or TGAI
90-Day Inhalation
82-5 - 90-Day Neurotoxicity TGAI
Chronic Testing
83-1 - Chronic Testing
- Rodent TGAI
- Nbnrodent TGAI
83-2 - Qncogenicity
- Rat TGAI
- Mouse TGAI
83-3 - Teratogenicity
- Rat TGAI
- Rabbit TGAI
Does EPA
Have Data to
Satisfy This
Requirement?
Use (Yes, No or
Patterns Parti al ly )
All-5-/ No
All No
A,C,E No
A,C,E No
A,C,E Yes
A,C,E Yes
All Yes
All Yes
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data
Citation 3(c)(2)(B)? Submission
yes2_J.2/ 15 Months
Reserved^/
Yes^ ' 7/ 50 Months
Yes^ * 7/ 50 Months
00073372 NO
00073372 No
00153017 NO
00079016,00079017 No
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Data
S158.
Use
Requirement Composition Patterns
340 Toxicology
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or Bibliographic
Partially) Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Timeframe
For Data
Suhnission
Chronic Testing (cont'd)
83-4
- Reproduction TGAI A,C,E
No
Yes
39 Months
(90 Days
Protocol )
Mutagenicity Testing
84-2 - Gene Mutation TQM
84-2 - Chromosome Aberration TGAI
84-4 - Other Mechanisms of TGAI
Mutagenicity (Sister
Chromatid Exchange)
Special Testing
85-1 - General Metabolism PAI or
PAIRA
- Antidote
All Partially 00132952
All No
All Partially 00142045
A,C,E No
NO
Reserved8'12/
12/
12.
Yc
/
Yes
Reserved11'12/
12 Months
12 Months
24 Months
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
K3
Ln
S158.340 Toxicology Footnotes;
a/ For those data requirements identified in the May 1987 Comprehensive Data Call-in, the operative due dates are those
stipulated in that document or as officially extended by the EPA in response to registrant's request. For any new
data requirement imposed by this Registration Standard, the operative due dates are those iirposed under this
Registration Standard.
!/ The Agency recently reviewed an acute neurotoxicity study in hens which was found to be "equivocal." This study is
unacceptable.
2/ Studies conducted must establish NOEL'S for plasma, RBC, and brain cholinesterase activity as well as standard
parameters recommended in Subdivision F of the EPA Health Assessment Guidelines.
3/ All uses resulting in repeated dermal exposure.
4/ Reserved pending results of the 21-day dermal study.
5/ All uses resulting in repeated indoor inhalation exposure.
6/ Reserved pending results of the acute delayed neurotoxicity study (81-7).
I/ Registrants who conduct chronic feeding and/or oncogenicity studies should inform the Agency in writing of the
dosage levels planned and their reasons for believing that the highest dose approaches or equals the maximum
tolerated dose observed in subchronic or range-finding studies, and must also consult with the Agency to determine
that the appropriate dosage levels are being used in the chronic feeding and/or oncogenicity studies. If EPA sub-
sequently determines that the study was conducted using a dosage rate that was too low to assess long-term effects,
the study may be deemed not to satisfy the data requirement.
8/ The Agency will assess the need for in vitro mammalian gene mutation studies (i.e. , mouse lymphoma L51784 and
Chinese hamster type assays) after evaluating data required to address potential for structural chromosomal
aberrations and potential for inducing sister chromatid exchange both in vivo and in vitro.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
5158.340 Toxicology Footnotes;
9/ A mouse micronucleus test is required to evaluate structural chromosome aberrations.
1Q/ Studies on both in vivo and in vitro sister chromatid exchange assays are required. In addition, registrants must
submit a summary table of all readily available mutagenicity studies on diazinon including literature references.
ll/ The Agency is reserving judgment on the need for this study. In response to the 1987 DCI, the registrant has
committed to submit a published literature summary of reasonable scope demonstrating the effectiveness of the
antidotes, atropine, and 2-PAM, in lieu of conducting effectiveness studies. After review of the submission, the
Agency will determine if any additional studies are required to adequately define the effectiveness of atropine and
2-EAM as antidotes for diazinon.
12/ Study(ies) currently under review.
-------
Table A
Generic Data Requirements for Diazinon
Data Requirement
Comoosition
Use
Patterns
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For DataA/
3(c)(2)(B)? Submission
§158.490 - Wildlife and Aquatic Organisms
Avian and Mammalian Testing
71-1 - Avian Acute Oral Toxicity
Waterfowl TGAI A ,B, C, E,
EP AiB,C,E,
- Songbird
- Upland game bird
71-2 - Avian Dietary 1X50
- Waterfowl
Yes
No
TGAI A,B,C,E, Yes
EP A,B,C,E, Partially
TGAI A,B,C,E, Yes
EP A,B,C,E, Yes
TGAI A,B,C,E, Partially
EP A,B,C,E, Partially
40922901,40922902 No
Yesi/
00020560
00148695
00148703
00148703
NO
Yes2/
No
NO
00022923
40910901
Yes
Yes3-/
9 Months
9 Months
(90 Days)
Protocol)
9 Months
9 Months
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
ro
00
Composition
Use
Patterns
S158.490 - Wildlife and Aquatic Organisms
Avian and Mammalian Testing (cont'd)
71-2 - Avian Dietary LC50 (cont'd)
- Songbird TGAI A,B,C,E,
EP
- Upland game bird
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Partiall)
No
A,B,C,E, Nb
TGAI A,B,C,E, Yes
Bibliographic
tion
00022923
Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data
3(c) (2) (B)? Submission
No
Yes4/
No
9 Months
(90 Days
Protocol)
EP
A,B,C,E, Yes
40910905,40910902 No
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Use
Data Requirement Composition Patterns
$158.490 - Wildlife and Aquatic Oraanisms
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or Bibliographic
Partially) Citation
Must Additional
Data Be Sutmitted
Under FIFPA Section
3(c)(2HB)7
Timeframe
For Data
Submission
Avian and Mammalian Testing (cont'd)
71-4 - Avian Reproduction
- Upland Game Bird TGAI A,B,C,H
Yes5/
24 Months
(90 Days
Protocol)
- Waterfowl
71-5 - Actual Field Testing
For Birds
TOM A,B,C,H NO
EP
A,B,C,H NO
24 Months
(90 Days
Protocol)
30 Months
(90 Days
Protocol)
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
UJ
o
Data Requirement Composition
§158.490 - Wildlife and Aquatic Organisms
Aquatic Organism Testing
72-1 - Freshwater Fish LC50
- Coldwater TGAI
EP
- Warmwater TGAI
EP
72-2 - Freshwater Invertebrate LC50
TGAI
EP
Use
Patterns
A,B,C,
E,I,H
A,B,C,
E,I,H
A,B,C,
E,I,H
A,B,C,
E,I,H
A,B,C,
E,I,H
A,B,C,
E,I,H
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Partially)
Yes
Partially
Yes
Partially
Yes
Partially
Bibliographic
Citation
00104923,40094602
00118393
00104923,40094602,
40910904.
00118393
00109022,40094602
00121283
Must Additional
Data Be Submitted
Under FIFRA Section
3(C)(2)(B)?
NO
Yes8'18/
NO
Yes9'18/
No
YeslQ/
Timeframe
For Data
Submission
9 Months
9 Months
9 Months
72-3 - Estuarine and Marine
Organisms
- Fish
TGAI
A,B,C
Yes
40914801
NO
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Data
5158.
Does EPA
Have Data to
Satisfy This Most Additional
Requirement? Data Be Submitted Timeframe
Use (Yes, No or Bibliographic Under FIFRA Section For Data
Reouirement Composition Patterns Partially) Citation 3(c)(2)(B)? Submission
490 - Wildlife and Aquatic Organisms
Aquatic Organism Testing (cont'd)
72-3
72-4
72-5
72-6
- Estuarine and Marine
Organisms LC5o (cont'd)
- MollUSk TGAI A,B,C No
EP A,B,C NO
- Shrinp TGAI A,B,C No
EP A,B,C NO
- Fish Early Life Stage and
Invertebrate Life Cycle
- Freshwater
- Fish TGAI A,B,C,H No
- Invertebrates TGAI A,B,C,H No
- Fish Life Cycle TGAI A,B,C,H No
- Aquatic Organisms PAIRA A,B,C,H No
Yegll,18/ 12 Months
Reserved^/
Yegl3,18/ 12 Months
Reserved^4-/
Yes14'18/ 15 Months
Yegl4,18/ 15 Months
Reserved^/
Y6gl6 ,18/ Y2. Months
Accumulation
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Data Requirement
Composition
Use
Pattern
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes,Wo, or
Partially)
Biblographic
Citation
Must Additional
Data Be Submittted
Under FIFRA
3(c)(2)(B)
Timeframe
For Data
Submission
S158.490 - Wildlife and Aquatic Organisms
Aquatic Organism Testing (cont'd)
72-7 - Simulated or Actual Field
Testing
- Aquatic Residue
Monitoring
EP
A,B,C,H
30 Months
(90 Days
(Protocol)
a/ For those data requirements identified in the May 1987 Comprehensive Data Call-in, the operative due dates are those
stipulated in that document or as officially extended by the EPA in response to registrant's request. For any new
data requirement imposed by this Registration Standard, the operative due dates are those imposed under this
Registration Standard.
I/ Avian acute oral toxicity (single-dose oral 11)50) testing with a waterfowl species (preferably the mallard) is
required with diazinon 14% (ai) granular formulation and with the 48% (ai) emulsifiable concentrate formulation.
For testing granular formulations, the ID50 is to be calculated as the number of granules required to cause 50%
mortality. Additional testing with on other end-use product formulations are reserved pending results of these
studies.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
§158.490 Wildlife and Aquatic Organism Footnotes (cont'd)
2/ Avian acute oral toxicity (single-dose oral 11)59) testing with a songbird species (preferably the brown-headed.
cowbird) is required with diazinon 14% (ai) granular formulation and with the 48% (ai) emulsifiable concentrate
formulation. For testing granular formulations, the 11)50 ^s to k® calculated as the number of granules required to
cause 50% mortality. The protocol must be submitted within ninety (90) days of receipt of this standard for Agency
approval before conducting this study. Additional testing on other end-use product formulations is reserved
pending results of these studies.
3/ Avian subacute dietary toxicity (dietary K^Q) testing with a waterfowl species (preferably mallard) is required
with diazinon 48% (ai) emulsifiable concentrate formulation. Additional testing on other end-use product
formulations are reserved pending results of these studies.
4/ Avian subacute dietary toxicity (dietary T-C$Q) testing with a songbird species (preferably the brown-headed
cowbird) is required with diazinon 48% (ai) emulsifiable concentrate formulation. Additional testing with on other
end-use product formulations are reserved pending results of these studies. The protocol must be submitted with
ninety (90) days of receipt of this Standard for Agency approval before conducting this study.
5_/ Avian reproduction studies with TGAI are required for an upland game bird species (preferably the bobwhite or other
native quail or the ringed-neck pheasant). The TGAI to be tested must be identified with respect to purity. The
percent (or parts per million) content of all organophosphorus impurities must be identified. In particular, the
concentration of sulfotepp, if any, must be stated. In addition, plasma cholinesterase levels must be measured.
An acceptable protocol must be submitted.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.490 Wildlife and Aquatic Organism Footnotes (cont'd)
6/ Avian reproduction studies with TGAI are required for a waterfowl species (preferably the mallard). The TGAI to be
tested must be identified with respect to purity. The percent (or parts per million) content of all organophos-
phorus irrpurities must be identified. In particular, the concentration of sulfotepp, if any, must be stated. The
standard protocol, as in the EPA Guidelines, should be expanded to include behavioral monitoring for such effects
as decreased nest attentiveness (i.e., birds must be allowed to naturally incubate eggs). In addition, plasma
cholinesterase levels must be measured. An acceptable protocol must be submitted to the Agency for approval a
minimum of 90 days prior to the anticipated date of test initiation.
2/ Actual field testing with birds is required as per 40 CFR 158.490. Testing conducted on alfalfa and apples must be
done with the 48% ai diazinon emulsifiable concentrate at the maximum application rate (4 Ib ai/A). Testing
conducted on corn with the 14.3% ai granular must be conducted in no-till fields to ensure the greatest
likelihood of wildlife exposure. Testing must include a minimum of 8 sites plus a control in each geographic area.
Two geographic areas must be studied for each of the following crops: alfalfa, corn, and apples. Areas selected
should attempt to maximize the variety of avian exposure and improve the chances that potential adverse effects
will not be missed. Residue analysis of avian food items, and carcass searching to determine the extent of
diazinon-induced mortality is required. Additional field testing, including testing on other crops, is reserved
pending results of these studies. Cancellation of any of the above use patterns would obviate the need for testing
of these uses. However, since further studies are reserved pending the results of the above testing, other sites
may be required to be substituted. Acceptable protocols for conducting the studies, including quantitative
description of the proposed test sites and detailed descriptions of proposed methodology and sample sizes, must be
submitted to the Agency no later than 90 days prior to the anticipated date of study initiation. In developing
protocols, the registrant must follow the Agency's most recent draft "Guidance Document for Conducting Terrestrial
Field Studies", for level I studies.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.490 Wildlife and Aquatic Organism Footnotes (cont'd)
8/ Acute toxicity (LC5g) studies with a warmwater fish species are required using a diazinon 48% ai emulsifiable
concentrate EP.
9/ Acute toxicity (LC50) studies with a coldwater fish species are required using a 48% ai diazinon emulsifiable
concentrate EP.
1Q/ Acute toxicity (LC5o) studies with a freshwater invertebrate species are required with a 48% ai diazinon
emulsifiable concentrate EP.
ll/ Acute toxicity testing of the TGAI to oysters is required because diazinon is labeled for use on crops grown in
more than 300,000 acres in coastal counties and other crops/sites with a large percentage of of their acreage in
coastal areas. These include citrus, cotton, corn, cranberries, clover, peanuts, pasture, sorghum, sugarcane, and
tobacco. The TGAI to be tested must be identified with respect to purity. The percent (or parts per million)
content of all organophosphorus impurities must be identified. In particular, the concentration of sulfotepp, if
any, must be stated.
12/ Formulated product testing for acute toxicity to estuarine and marine organisms is reserved pending the results of
testing with TGAI.
13/ Acute toxicity testing of the TGAI to shrimp is required because diazinon is labeled for use on crops grown in more
than 300,000 acres in coastal counties and other crops/sites with a large percentage of their acreage in coastal
areas. These include citrus, cotton, corn, cranberries, clover, peanuts, pasture, sorghum, sugarcane, and tobacco.
The TGAI to be tested must be identified with respect to purity. The percent (or parts per million) content of all
organophosphorus impurities must be identified. In particular, the concentration of sulfotepp, if any, must be
stated.
14/ The TGAI to be tested in both the fish early life stage and aquatic invertebrate life cycle studies must be
identified with respect to purity. The percent (or parts per million) content of all organophosphorus impurities
must be identified. In particular, the concentration of sulfotepp, if any, must be stated.
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
S158.490 Wildlife and Aquatic Organism Footnotes (cont'd)
15/ Reserved pending the results of the fish early life stage testing, §158.490 72-4, and aquatic residue monitoring.
16/ Testing is required as per §158.490 (72-6) and §158.490 (165-4), laboratory fish accumulation. Testing with
additional species are reserved, pending receipt and review of this data.
17/ Aquatic residue monitoring is required on alfalfa, apples, citrus, and cranberries. A variety of aquatic habitats
must be sampled whenever possible (e.g., shallow ponds, deeper ponds, streams, bays, etc.) Maximum application
rates should be tested (eg., 10 Ib ai/A for citrus). Citrus groves must be flooded to maximize potential aquatic
exposure. Additional residue monitoring studies are reserved pending results of these studies.
Full field testing to examine effects on aquatic invertebrates and fish is required on alfalfa, apples, citrus, and
cranberries. A minimum of three sites per test is required. The study duration is a minimum of two (2) years.
Mesocosm studies are an alternative to full field testing, however; mesocosm studies must be conducted on a
range of test levels that are adequate to model the full range of potential aquatic exposure under diazinon's
use patterns. Additional field testing on other sites is reserved pending results of these studies. Voluntary
cancellation of any of the above uses, including both FIFRA section 3 and section 24c registrations, would
obviate the need for testing of those uses. However, since further studies are pending the results of the above
testing, other sites may be required to be substituted. Acceptable protocols for conducting the studies, including
quantitative description of the proposed test sites and detailed descriptions of proposed methodology and sample
sizes, must be submitted to the Agency no later than 90 days prior to the anticipated date of study initiation A
draft Guidance Document regarding mesocosm studies is presently available. A final document will be developed
following an anticipated Scientific Advisory Panel review later this year.
IS/ Study (ies) currently under review.
-------
Table A
Generic Data Requirements for Diazinon
Data Requirement
Composition
Use
Patterns
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data3/
3(c)(2)(B)? Submission
OJ
—I
S158.540 Plant Protection
AREA PHYTOICXICITY
121-1 - Target Area
Phytotoxicity
NCMIA
r AREA PHYTQTOXICITY
TIER I
122-1 - Seed Germination/
TEP
TGAI
Seedling Emergence
122-1 - Vegetative Vigor TGAI
122-2 - Aquatic Plant Growth TGAI
TIER II
122-1 - Seed Germination/ TGAI
Seedling Emergence
122-1 - Vegetative Vigor TGAI
122-2 - Aquatic Plant Growth TGAI
B
B
B
B
B
NO
Yes
No
No
Yes
40509805
40509806
NO
NO
B
B
Yes
Yes
40509804
40509806
No
No
No
9 Months
9 Months
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Does EPA
Have Data to
Satisfy This Must Additional
Requirement? Data Be Submitted Timeframe
Use (Yes, No or Bibliographic Under FIFRA Section For Data
Data Requirement Composition Patterns Partially) Citation 3(c) (2) (B)? Submission
^158.540 Plant Protection
NOSTIARGET AREA PHYTOTQXICITY (Cont'd)
TIER III
124-1 - Terrestrial Field TGAI B No Reserved2-/
124-2 - Aquatic Field TGAI B No Reserved2-/
a/ For those data requirements identified in the May 1987 Comprehensive Data Call-in, the operative due dates are those
stipulated in that document or as officially extended by the EPA in response to registrant's request. For any new
data requirement imposed by this Registration Standard, the operative due dates are those imposed under this
Registration Standard.
!/ Study (ies) currently under review.
2/ Reserved pending results of Tier II.
-------
u>
VD
Table A
Generic Data Requirements for Diazinon
Data Requirement Composition
11 158. 590 Nontaraet Insects
NCMTARGET INSECT TESTING - PQLT
141-1 - Honey Bee Acute
Contact LD50
141-2 - Honey Bee - Tbxicity
.INATORS
TGAI
EP
Does EPA
Have Data to
Use Satisfy This
Patterns Requirement?
A,B,G,H Yes
A,B,G,H No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2HB)?
00036935,00162751 No
No
Timeframe
For DataA/
Submission
Residues on Foliage
141-4 - Honey Bee Reserved^/
Subacute Feeding
Study
141-5 - Field Testing for
Pollinators
EP
A,B,G,H
NO
NOXnARGET INSECT TESTING - AQUATIC INSECTS
142-1 - Acute Tbxicity to EP
Aquatic Insects
142-2 - Aquatic Insect Life EP
Cycle Study
142-3 - Simulated or Actual EP
Field Testing for
Aquatic Insects
No2/
Reserved^/
Reserved^/
Reserved3-/
-------
Table A
Generic Data Requirements for Diazinon (cont'd)
Data Requirement
Composition
Use
Patterns
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(0(2) (B)?
Timeframe
For Data
Submission
-"158.590 Nontaraet Insects
NQNTARGET INSECT TESTING - PRTTiATQRS AND PARASITES
143-1 EP A,B,G,H
thru
143-3
N/A
05003978,05004148
05005640,05009345.
Reserved^/
•e-
o
a/ For those data requirements identified in the May 1987 Comprehensive Data Call-in, the operative due dates are those
stipulated in that document or as officially extended by the EPA in response to registrant's request. For any new
data requirement imposed by this Registration Standard, the operative due dates are those imposed under this
Registration Standard.
I/ This requirement is reserved pending development of test methodology.
2/ Data reviewed in lower-tier studies do not indicate the need for field testing.
3/ This requirement is reserved pending Agency decision as to whether the data requirement should be established.
4/ These studies were reviewed in order to provide an assessment of diazinon to non-target insects. Since the Agency
has not determined whether this data requirement should be established, an evaluation of these studies to determine
fulfillment of the data requirement is not appropriate at this time.
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Diazinon
Data Requirement
Composition
Part 158, Subpart Cf Product Chemistry
Product Identity and Composition
61-1 - Product Identity and MP
61-2 - Description of Beginning MP
Materials and Manufacturing
Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis of MP
Product Samples
62-2 - Certification of Ingredient MP
Limits
62-3 - Analytical Methods to Verify MP
Certified Limits
Physical and Chemical Characteristics
63-2 - Color MP
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Noi/
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Timeframe
For Data^/
Yes2-/
Yes3-/
Yes2/
Yes8/
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Diazinon (cont'd)
Data Requirement
Part 158, Subpart Cf Product Chemistry
Physical and Chemical Characteristics
63-3 - Physical State
63-4 - Odor
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing Agent
63-15 - Flammability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
Composition
(cont'd)
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or Bibliographic
Partially) Citation
Noi/
Noi/
Noi/
Noi/
NO1/
Nbi/
NO1/
NO1/
Noi/
Noi/
Must Additional
Data Be Submitted
Under FIFRA Section
3(c) (2) (B)?
Yes5/
Yes5/
Yes5/
Yes5^/
Yes8'10/
Yes8'11/
Yes8-12-/
Yes8'14/
Yes8'13/
Yes^/
Timeframe
For Data
Submission
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
15 Months
Other Requirements
64-1 - Submittal of Samples
N/A
N/A
N/A
NO
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Diazinon (cont'd)
Subpart C, Product Chemistry Footnotes
a/ For those data requirements identified in the May 1987 Comprehensive Data Call-in, the operative due dates are
those stipulated in that document or as officially extended by the EPA in response to registrant's request. For
any new data requirement imposed by this Registration Standard, the operative due dates are those imposed under
this Registration Standard.
I/ Although product chemistry may have been submitted in the past, the Agency has determined that these data must be
resubmitted for each pesticide. New data requirements have been introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
2/ The chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and purpose of the active
ingredient in each intentionally added inert must be provided. For the active ingredients, the following must also
be provided: the product, common and trade names; the molecular, structural, and empirical formulas; the molecular
weight or weight range; and any experimental or internally assigned code numbers.
3/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition, the name and
address of the manufacturer, producer, or supplier of each beginning material must be provided, along with
information regarding the properties of each beginning material used to manufacture each product.
4/ A detailed discussion of all impurities that are or may be present at > 0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted. The discussion must specifically address the potential for the formation of
diazoxon, TEPP and its sulfur derivatives.
5/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each
analytical method used.
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Diazinon (cont'd)
Part 158, Subpart C, Product Chemistry Footnotes (cont'd)
6/ Upper and lower limits for the active ingredients and each intentionally added inert, and upper limits for each
impurity present at > 0.1% (w/w) and each "toxicologically significant" impurity present at < 0.1% (w/w) must be
provided and certified. Also, an explanation of how each certified limit was established must be provided (e.g. ,
sample analysis using validated analytical procedures, quantitative estimates based on amounts of ingredients used,
etc.). Limits for impurities not associated with the active ingredient need be provided only if they are
considered to be of toxicological significance, regardless of the concentration at which they are present.
Certification must be submitted on EPA Form 857 Rev. 2-85.
2/ Analytical methods must be provided to determine the active ingredient, and each toxicologically significant
impurity and intentionally added inert for which certified limits are required. Each method must be accompanied by
validation studies indicating its accuracy and precision. These methods must be suitable for enforcement of
certified limits.
.§/ Physicochemical characteristics (color, physical state, odor, melting point, specific gravity, solubility, vapor
pressure, dissociation constant, partition coefficient, pH, and stability) as required in 40 CFR 158.190 and more
fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
9/ Data required if the test substance is dispersible in water.
1.0/ Data required if the product contains an oxidizing or reducing agents.
ll/ Data required if the product contains combustible liquids.
12/ The test must be conducted with the product in its commercial package. Diazinon and its sulfur derivatives must be
analyzed for at the beginning and at the end of the test period. Products must be tested for one year under either
of the following conditions: (i) at 20°C or 25°C, and, if the package is permeable, at a relative humidity of 50%;
(ii) under warehouse conditions which reflect the expected storage conditions of the commercial product.
13/ Data required if the product is a liquid.
14/ Data required if the product is a liquid and is to be diluted with petroleum solvents.
-------
Table B
Product-Specific Data Requirements for Manufacturing Use Products Containing Diazinon
Data
^158
81-1
81-2
81-3
81-4
81-5
81-6
Requirement
.340 Toxicology
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation
- Eye Irritation
- Dermal Irritation
Composition
MUP
MUP
MUP
MUP
MUP
- Dermal Sensitization MUP
Use
Patterns
All
All
All
All
All
All
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or Bibliographic
Partially) Citation
No
No
No
No
No
NO
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
YesJ-3/
Yesi/
Yesl/
Yes^/
Yesi/
Yesl/
Timeframe
For DataA/
Submission
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
Special Testing
6 -Week Oral Feeding
(Rat)
MUP
All
No
Yes1.2-3/
15 Months
(90 day
protocol )
-------
Table B
Product-Specific Data Requirements for Manufacturing Use Products Containing Diazinon
Part 158.340 Toxicology Footnotes
a/ For those data requirements identified in the May 1987 Comprehensive Data Call-in, the operative due dates are those
stipulated, in that document or as officially extended by the EPA in response to registrant's request. For any new
data requirement imposed by this Registration Standard, the operative due dates are those imposed under this
Registration Standard.
•I/ Each registrant of a manufacturing use product must submit product specific data for his own product.
2/ This study must define NDELs for plasma, erythrocyte and brain Cholinesterase inhibition.
3/ In order to determine the similarity or dissimilarity between the registered manufacturing use products,
the Agency requires that the Sprague-Dawley strain of rat be used for this study. Registrants are required
to contact the Agency prior to initiation of this study for the purpose of establishing standard experimental
procedures for required testing.
-------
Table C
Product-Specific Data Requirements for End-Use Products
Containing Diazinon
Data Requirement Composition
Part 158, Subpart C, Product Chemistry
Product Identity and Composition
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Timeframe
For Data3/
Submission
61-1 - Product Identity and EP
Composition
61-2 - Description of Beginning EP
Materials and Manufacturing
Process
61-3 - Discussion of Formation EP
of Impurities
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis of EP
Product Samples
62-2 - Certification of Ingredient EP
Limits
Physical and Chemical Characteristics
Noi/
Noi/
Yes2-/
Yes3-/
Yes5/
9 Months
9 Months
9 Months
9 Months
9 Months
63-7 - Density, Bulk Density, or
Specific Gravity
EP
Noi/
Yes2/
9 Months
-------
Table C
Product-Specific Data Requirements for End-Use Products
Containing Diazinon
Data Requirement
Composition
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or
Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c) (2) (B)?
Timeframe
For Datas^
Submission
Part 158, Subpart C, Product Chemistry
Physical and Chemical Characteristics (cont'd)
63-12 - pH EP Noi/
63-15 - Flammability EP
9 Months
9 Months
00
Other Requirements
Special Storage Stability
EC
No
Yesio/
27 Months
a/ For those data requirements identified in the May 1987 Comprehensive Data Call-in, the operative due dates are those
stipulated in that document or as officially extended by the EPA in response to registrant's request. For any new
data requirement iitposed by this Registration Standard, the operative due dates are those imposed under this
Registration Standard.
I/ Although product chemistry may have been submitted in the past, the Agency has determined that these data must be
resubmitted for each pesticide. New data requirements have been introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
2/ The chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and purpose of the active
ingredient in each intentionally added inert must be provided. For the active ingredients, the following must also
be provided: the product, common and trade names; the molecular, structural, and empirical formulas; the molecular
weight or weight range; and any experimental or internally assigned code numbers.
-------
Table C
Product-Specific Data Requirements for End-Use Products
Containing Diazinon (cont'd)
Part 158, Subpart C. Product Chemistry Footnotes (cont'd)
reaction, equipment used to produce each, intermediate and the final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition, the name and address
of the manufacturer, producer, or supplier of each beginning material must be provided, along with information
regarding the properties of each beginning material used to manufacture each product.
4/ A detailed discussion of all impurities that are or may be present at > 0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted. The discussion must specifically address the formation of diazoxon, TEPP and
its sulfur derivatives.
5/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each
analytical method used. Required for products produced by an integrated system.
6/ Upper and lower limits for the active ingredients and each intentionally added inert, and upper limits for each
impurity present at > 0.1% (w/w) and each "toxicologically significant" impurity present at < 0.1% (w/w) must be
provided and certified. Also, an explanation of how each certified limit was established must be provided (e.g. ,
sample analysis using validated analytical procedures, quantitative estimates based on amounts of ingredients used,
etc.). Limits for impurities not associated with the active ingredient need be provided only if they are
considered to be of toxicological significance, regardless of the concentration at which they are present.
Certification must be submitted on EPA Form 857 Rev. 2-85.
2/ Density (or specific gravity, pH, and flammability information must be submitted for each product as part of the
Confidential Statement of Formula. Other Physicochemical characteristics (color, physical state, odor, melting
point, solubility, vapor pressure, dissociation constant, partition coefficient, and stability) as required in 40
CFR 158.190 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, are not required at
this time.
8/ Data required if the test substance is dispersible in water.
9/ Data required if the product contains combustible liquids.
-------
Table C
Product-Specific Data Requirements for End-Use Products
Containing Diazinon (cont'd)
Part 158, Subpart C, Product Chemistry Footnotes (cont'd)
IQ/ The test must be conducted for each EC (emulsifiable concentrate) product in its commercial package. Five
representative samples must be analyzed. Diazinon and any of its impurities and/or degradates must be identified
and quantitated at the beginning and at the end of the test period. All compounds occurring at > 0.1% in the
product must be identified and quantitated. Compounds of special toxicological concern such as diazoxon, TEPP and
its sulfur derivatives will require characterization and/or analysis regardless of the concentration at which they
are present.
Packaging must be open prior to analysis at each of the required sample analysis testing intervals; immediately
after batch processing, 6 months, 15 months, 18 months and 24 months. Products must be stored under typical
conditions which reflect the expected storage conditions of the product.
Ul
o
-------
Table C
Product Specific Data Requirements for End-Use Products
Containing Diazinon
Data
S158
81-1
81-2
81-3
81-4
81-5
81-6
Requirement
.340 Toxicology
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation
- Eye Irritation
- Dermal Irritation
- Dermal Sensitization
Composition
TEP -/
TEP -I/
TEP -/
TEP -/
TEP -/
TEP -/
Use
Patterns
All
All
All
All
All
All
Does EPA
Have Data to
Satisfy This
Requirement?
(Yes, No or Bibliographic
Partially) Citation
No
No
No
No
No
No
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2) (B)?
Yes
Yes
Yes
Yes
Yes
Yes
Timeframe
For Data
Submission
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
Special Testing
81-1
81-2
- Acute Oral - Rat
- Acute Dermal
EP
EP
All
All
No
No
Reserved -2/
Reserved -27
-------
Ln
Table C
Product Specific Data Requirements for End-Use Products
Containing Diazinon
S 158.340 Toxicology Footnotes
I/ Testing is required on a typical end-use formulation containing the following active ingredient percentages:
FOEMJLATICM
Emulsifiable
concentrate
Dust
Wettable Powder
Granular
Granular
DIAZIMU
48%
48%
25%
25%
12.5%
12.5%
12.5%
1.0%
50%
14%
5.0%
PETROLEUM DISTILLATE
(25-40)
(50-60)
(30-40)
(50-60)
N.A
N.A.
N.A.
N.A.
xvr.TOF
(25-40)
(50-60)
(50-60)
N.A.
N.A.
N.A.
N.A.
2/ Testing is reserved pending evaluation of Table C product chemistry data requirements.
-------
II. LABELING APPENDICES
153
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 156.10 requires that certain specific labeling
statements appear at certain locations on the label. This is
referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will not
be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address of
the registrant or distributor is required on the label. The
name and address should preferably be located at the bottom of
the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net consents statement is required
on all labels or on the container of the pesticide. The
preferred location is the bottom of the front panel immediately
above the company name and address, or at the end of the label
test. The net contents must be expressed in the largest
suitable unit, e.g., "1 pound 10 ounces" rather than "26
ounces." In addition to English units, net contents may be
expressed in metric units. [40 CFR 156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number
assigned to the pesticide product must appear on the label,
preceded by the phrase "EPA Registration No.," or "EPA Reg. No."
The registration number must be set in type of a size and style
similar to other print on that part of the label on which it
appears and must run parallel to it. The registration number
and the required identifying phrase must not appear in such a
manner as to suggest or imply recommendation or endorsement of
the product by the Agency. [40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final
establishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of the
package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or
container. [40 CFR 156.10(f)]
154
-------
SUMMARY-2
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active
ingredient and the total percentage by weight of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with,
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. [40 CFR
156.10(g) ]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label
on Front Panel
in Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word "Keep Out of Reach
Minimum Type Size of Children"
All Capitals Minimum Type Size
6 point
10 point
12 point
14 point
18 point
6 point
6 point
8 point
10 point
12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The Statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely.
[40 CFR 156.I0(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the
child hazard warning statement.
[40CFR I56.10(h)(l)(i)].
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxicity, the word "Poison" shall appear on the
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximicy +•'-> *-*'
word POISON.
[40 CFR 156.10(h)(1)(i)].
label
to the
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement Of
practical treatment (first aid or other) shall appear on the
label of pesticide products in toxicity Categories I, II, and
III. [40 CFR 156.10(h)(1)(iii)]
155
-------
SUMMARY-3
Item 7E. REFERRAL STATEMENT - The statement "see Side (or
Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 156.10(h)(1)(iii) ] .
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on
the label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that
these statements be surrounded by a block outline. Each of the
three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 156.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic afrimals, precautionary
statements are required indicating ttye particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 156.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 156.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria in
the PHYS/CHEM Labeling Appendix. The requirement is based on
the results of the flashpoint determinations and flame extension
tests required to be submitted for all products. These
statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is used
in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified for
either general or restricted use. Products classified for
restricted use may be limited to use by certified applicators or
persons under their direct supervision (or may be subject to
other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
156
-------
SUMMARY-4
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified for
restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During the
Agency's review of your application, your proposed
classification determination will be evaluated in accordance
with the provisions of 40 CFR 162.11(c). You will be notified
of the Agency's classification decision.
Classification Labeling Requirements
If your product has been classified for restricted use, the
following label requirements apply:
l. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 40 CFR 156.10(h)(1)(iv).
b. Directly below this statement on the front
panel, a summary statement of the terms of
restriction must appear (including the reasons for
restriction if specified in Section I). If use is
restricted to certified applicators, the following
statement is required: "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."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified for
restricted use, and some are unclassified, several courses of
action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses
that are unrestricted, but you may not distinguish
them on the label as being unrestricted.
157
-------
SUMMARY-5
b. You may delete all restricted uses from your
label and submit draft labeling bearing only
unrestricted uses.
c. You may "split" your registration, i.e.,
register two separate products with identical
formulations, one bearing only unrestricted uses,
and the other bearing restricted uses. To do so,
submit two applications for reregistration, each
containing all forms and necessary labels. Both
applications should be submitted simultaneously.
Note that the products will be assigned separate
registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling." This
statement appears at the beginning of the directions for use,
directly beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a reentry interval has
been established by the Agency, it must be included on the
label. Additional worker protection statements may be required
in accordance with PR Notice 83-2, March 29, 1983.
158
-------
SUMMARY-6
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the
directions for use. This heading must be set in the same type
sizes as required for the child hazard warning. Refer to
Appendix II, STOR, PEST/DIS, and CONT/DIS to determine the
storage and disposal instructions appropriate for your
products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be
stated in terms which can be easily read and understood by the
average person likely to sue or to supervise the use of the
pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. [40
CFR 156.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and
submitted for review.
159
-------
SUMMARY-7
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
l
2
3
4
5
6A
6B
7
7A
7B
TARFT, FT.FTVtEOT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gal ion
statement
Front panel
precaut ionary
statements
Keep Out of Reach
of Children
(Child hazard
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage is
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
ON LABEL
PREFERRFD
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel
immediately
before or
following
Rea. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . . , "
"Distributed by . . . ." etc.
May be in metric units in addition to
U.S. units.
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
SUMMARY-8
LABELING REQUIREMENTS OF THE FIFRA. AS AMEM)ED (cont'd)
ITEM
7C
7D
7E
8
8A
8B
LABEL FT.FMFiyr
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
i aiiutictis .
Envi ronmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxic ity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
L front panel
All products
All products
in Categories
I, II, and III
All products
PLACEMENT
REQUIRED
Front panel
Category I;
Front panel
unless refer-
ral statement
is used.
Others;
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
ON LARFT,
PRFTFFRPFD j
Both in close
proximity to
signal word
Front panel
for all
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where aoDlicable.
-------
SUMMARY-9
LABELING REQUIREMENTS OF THE FIFRA. AS AMEM)ED (cont'd)
ITEM
8C
9A
9B
10A
10B
IOC
TARFT. FT.FMENI
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
APPLICABILITY
OF REDUIREMNT
All pressurized
products, others
with flash
points under
150°T
All restricted
products
All products
PR Notice 83-2
or as determined
by the Aaencv
All products
All products
PLACEMENT
REDUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
CN LABEL
FREFFRRFT)
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
sional word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from other directions
for use.
Refer to Appendix II guides STQR,
CCNT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate container. Exposure
to temperatures above
130°F may cause bursting.
Extremely flammable.
Keep away from fire,
sparks, and heated
surfaces.
Flammable. keep away
from heat and open flame,
Do not use or store near
heat and open flame.
None required.
163
-------
STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading:
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of the
label under the heading STORAGE AND DISPOSAL. Products intended
solely for domestic use need not include the heading "STORAGE AND
DISPOSAL."
Storage Instructions:
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure while
opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been spilled,
and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides during
storage to prevent cross-contamination of other pesticides,
fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
164
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or feed
by storage or disposal."
2. Except those products intended solely for domestic use, the
labels of all products that contain active ingredients that are
Acute Hazardous Wastes or are assigned to Toxicity Category I on
the basis of oral or dermal toxicity, or Toxicity Category I or
II on the basis of acute inhalation toxicity must bear the
following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a
violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions, contact
your State Pesticide or Environmental Control Agency or the
Hazardous Waste representative at the nearest EPA Regional
Office for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste must bear the following pesticide
disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by use
according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office for
guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
5. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original container
in several layers of newspaper and discard in trash."
165
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container
Statement
Non-aerosol products
(bottles, cans, iars)
Non-aerosol products
(baas)
Aerosol products
1
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal
instructions, based on container type, listed below:
Container
Statement
Metal
containers
(non-aerosol )
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
|Triple rinse }(or equivalent). Then offer ]
! f or recycling or reconditioning, or puncture!
land dispose of in a sanitary landfill, or by!
! other procedures approved by state and local!
! authorities . !
JTriple rinse (or equivalent). Then offer j
! for recycling or reconditioning, or puncture!
land dispose of in a sanitary landfill, or |
I incineration, or, if allowed by state and
| local authorities, by burning. If burned,
| stay out of smoke.
|Triple rinse (or equivalent). Then dispose
] of in a sanitary landfill or by other
! approved state and local procedures.
] Completely empty liner by shaking and
] tapping sides and bottom to loosen clinging
I particles. Empty residue into application
! equipment. Then dispose of liner in a
I sanitary landfill or by incineration if
! allowed by state and local authorities.
[If drum is contaminated and cannot be
! reused1/, dispose of in the same manner.
| Completely empty bag into application
| equipment. Then dispose of empty bag in
|a sanitary landfill or by incineration,
I or, if allowed by State and local
[authorities, by burning. If burned, stay
lout of smoke. '
! Return empty cylinder for reuse (or j
! similar wording ). i
V Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
166
-------
III. BIBLIOGRAPHY APPENDICES
167
-------
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in arriving at
the positions and conclusions stated elsewhere in the Standard.
Primary sources for studies in this bibliography have been the
body of data submitted to EPA and its predecessor agencies in
support of past regulatory decisions. Selections from other
sources including the published literature, in those instances
where they have been considered, will be 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 attempted also 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, arid should be used
at any time specific reference is required. It is not related to
the six-digit "Accession Number" which has been used to identify
volumes of submitted studies; see paragraph 4(d)(4) below for a
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 identifier number is also to be
used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing standard
elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic
conventions used reflect the standards of the American National
Standards Institute (ANSI), expanded to provide for certain
special needs.
a. Author. Whenever the Agency could confidently
identify one, 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 author. As a
last resort, the Agency has shown the first
submitter as author.
168
-------
b. Document Date. When the date appears as four
digits with no question marks, the Agency took it
directly from the document. When a four-digit
date is followed by a question mark, the
bibliographer deduced the date from evidence in
the document. When the date appears as (19??),
the Agency was unable to determine or estimate the
date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a
document title. Any such editorial insertions are
contained between square brackets.
d. Trailing Parentheses. For studies submitted to
the Agency in the past, the trailing parentheses
include (in addition to any self-explanatory text)
the following elements describing the earliest
known submission:
(1) Submission Date. The date of the earliest
known submission appears immediately
following the word "received."
(2) Administrative Number. The next element,
immediately following the word "under," is
the registration number, experimental use
permit number, petition number or other
administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the
submitter, following the phrase "submitted
by." 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," standing 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. For example,
within accession number 123456, the first
study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-
AA.
169
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
MRID Citation
00020560 Schafer, E.W. (1972) The acute oral toxicity of 369 pesticidal,
pharmaceutical and other chemicals to wild birds. Toxicology
and Applied Pharmacology 21(? ):315-330. (Also in unpublished
submission received Apr 25, 1978 under 476-2180; submitted by
Stauffer Chemical Co., Richmond, Calif.; CDL:233577-C)
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W. et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report—Wildlife ANo. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report).
00031954 Davis, A.C.; Wilson, B.R.; Wolfenbarger, D.O.; et al. (1957) Di-
azinon Residues—Tomatoes. (Unpublished study received Mar 6,
1962 under 100-440; prepared by Univ. of Florida, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:000218-B)
00032666 Richardson, C. (1965) Diazinon Residues—Snap Beans: AG-A 1143.
(Unpublished study received Feb 21, 1967 under 100-460; submit-
ted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:000406-A)
00032881 Wene, G.P. (1965?) Diazinon Residues—Cottonseed (Seed, Hulls,
Crude Oil, Refined Oil, Screwpress Meal): AG-A 945. (Unpub-
lished study received Mar 26, 1965 under 100-460; prepared in
cooperation with Univ. of Arizona, Cotton Research Center, sub-
mitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:000377-A)
00032884 Bullock, R.C. (1964) Diazinon Residues—Oranges (Fruit): AG-A 916.
(Unpublished study received May 6, 1965 under 100-460; prepared
by Univ. of Florida, Indian River Field Laboratory, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:000378-B)
00033245 Crowell, H.H. (1962) Diazinon Residues—Turnips: AG-A 347. (Un-
published study received Mar 18, 1964 under 100-442; prepared in
cooperation with Oregon State Univ., Dept. of Entomology, sub-
mitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:000297-A)
00033664 Campbell, W.V. (1964) Diazinon Residues—Alfalfa (Forage): AG-A
477. (Unpublished study received Feb 7, 1964 under 100-460;
prepared in cooperation with North Carolina State Univ., Dept.
of Entomology, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:000364-A)
170
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
MRID Citation
00033669 Richardson, C.; Flanagan, J.H. (1963) Diazinon Residues—Radishes
(Roots): AG-A 542. (Unpublished study including AG-A 493, re-
ceived Nov 1, 1963 under 100-460; submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:000357-A)
00033670 Richardson, C. (1963) Diazinon Residues—Turnips (Foliage & Roots):
AG-A 543. (Unpublished study received Nov 1, 1963 under 100-
460; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
000357-B)
00033671 Campbell, W.V.; Eden, W.G.; Boush, G.M. (1963) Diazinon Residues—
Peanuts (Foliage & Nuts): AG-A 539. (Unpublished study includ-
ing AG-A 535, AG-A 374, AG-A 364..., received Oct 2, 1963 under
100-460; prepared in cooperation with North Carolina State
Univ., Dept. of Entomology and others, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:000356-A)
00033674 Shaw, F.R.; Hardee, D.D.; Apple, J.W.; et al. (1962) Diazinon Resi-
dues—Alfalfa: AGA-200. (Unpublished study including published
data, received Aug 7, 1963 under 100-464; prepared in coopera-
tion with Univ. of Massachusetts, Dept. of Entomology and oth-
ers, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
000354-B)
00033820 Davidson, W.E.; Taylor, D.; Threewitt, ?; et al. (1980) Summary:
[Diazinon]. (Unpublished study received Jul 8, 1980 under
OE2388; prepared in cooperation with Oklahoma State Univ., Div.
of Agriculture and Oklahoma, Dept. of Agriculture, submitted by
Interregional Research Project No. 4, New Brunswick, N.J.; CDL:
099508-A)
00034047 Westmoreland, W.G.; Szolics, M.; Beck, E.W.; et al. (1965) [Residue
Study on Bermudagrass]: AG-A 1027. (Unpublished study including
published data and AG-A 1061, 1135 and 1119, received May 16,
1969 under 100-461; prepared in cooperation with U.S. Agricul-
tural Research Service, Entomology Research Div., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:000414-A)
00034063 Reid, W.J., Jr. (1960) Diazinon Residues—Soybeans. (Unpublished
study received Aug 7, 1963 under 100-460; prepared in coopera-
tion with U.S. Agricultural Research Service, Entomology Re-
search Div., Fruit & Vegetables Insects Research Branch, submit-
ted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:000380-E)
171
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
MRID Citation
00034075 Chada, H.; Jenkins, L.E.; Rabdikph, N.M. (1963) Diazinon Residues—
Grain Sorghum. (Unpublished study received Aug 7, 1963 under
100-460 prepared in cooperation with Oklahoma State Univ., Dept.
Entomology and others, submitted by Ciba-Geigy Corp., Greensboro,
N.C. ; CDL:000380-M)
00034132 Jackson, R.D.; Fahey, J.E. (1963) Results of Residue Studies with
Diazinon Furnished by Geigy Chemical Company. (Unpublished
study received Jan 20, 1964 under 100-454; prepared by U.S.
Agricultural Research Service, Grain and Forage Insects Research
Branch and Pesticide Chemicals Research Branch, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:000320-D)
00034804 Jackson, R.; Weekman, G.T. (1961) Diazinon Residues—Corn: AG-A
237. (Unpublished study received Jan 20, 1964 under 100-454;
prepared in cooperation with Corn Borer Research Laboratory and
Univ. of Nebraska, Dept. of Entomology, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:000323-F)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
00055414 University of Puerto Rico (1962) [Diazinon Residues in Pineapple].
(Compilation; unpublished study including AG-A 275, received
Jun 12, 1965 under PP0362; submitted by Geigy Chemical Co.,
Ardsley, N.Y.; CDL:090392-H)
00055415 Gibson, K.E. (1961) Diazinon Residues—Sugar Beets: AG-A 206.
(Unpublished study received Jun 12, 1965 under PP0362; prepared
in cooperation with U.S. Dept. of Agriculture, submitted by
Geigy Chemical Co., Ardsley, N.Y.; CDL:090392-1)
00055418 Marucci, P.E.; Breakey, E.P. (1960) Diazinon Residues—Blueberries.
(Unpublished study received Jun 12, 1965 under PP0362; prepared
in cooperation with Rutgers Univ., Blueberry Research Labora-
tory and Washington State Univ., Western Washington Experiment
Station, submitted by Geigy Chemical Co.,5 Ardsley, N.J.; CDL:
090392-L)
172
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
MRID Citation
00055419 Breakey, E.P. (1960) Diazinon Residues—Blackberries. (Unpublished
study received Jun 12, 1965 under PP0362; prepared in coopera-
tion with Washington State Univ., Western Washington Experiment
Station, submitted by Geigy Chemical Co., Ardsley, N.Y.; CDL:
090392-M)
00055420 Adams, 0. (1960) Diazinon Residues—Boysenberries. (Unpublished
study received Jun 12, 1965 under PP0362; submitted by Geigy
Chemical Co., Ardsley, N.Y.; CDL:090392-N)
00055421 Breakey, E.P.; Westlake, W.E. (I960) [Diazinon Residues—Rasp-
berries and Loganberries]. (Unpublished study received Jun 12,
1965 under PP0362; submitted by Geigy Chemical Co., Ardsley,
N.Y.; CDL:090392-O)
00055425 Pineapple Research Institute (1961) Diazinon Residues—Pineapple.
(Compilation; unpublished study received Jun 12, 1965 under
PP0362; submitted by Geigy Chemical Co., Ardsley, N.Y.; CDL:
090392-S)
00055429 Gibson, K.E. (1961) [Diazinon Residues in Sugar Beets]. (Unpub-
lished study including AG-A 206, received Jun 12, 1965 under
PP0362; prepared in cooperation with U.S. Agricultural Research
Service, Entomology Research Div., submitted by Geigy Chemical
Co., Ardsley, N.Y.; CDL:090392-W)
00057235 Geigy Chemical Corporation (1955) Results of Tests on the Amount
of Residue Remaining Including Descriptions of the Analytical
Methods Used: [Diazinon]. Includes three undated methods en-
titled: Sulfide procedure for the determination of Diazinon
residues; Phosphorus procedure for the determination of Diazinon
residues; Pyrimidine procedure for the determination of Diazinon
residues. (Unpublished study received Jan 24, 1956 under
PP0056; CDL:090105-D)
00057665 Geigy Chemical Company (1966) Results of Tests on the Amount of
Residue Remaining Including Descriptions of the Analytical
Methods Used: [Diazinon]. (Reports by various sources; unpub-
lished study received Jan 2, 1967 under 7F0576; CDL:090737-E)
00061987 Geigy Chemical Corporation (1956) Results of Tests on the Amount
of Residue Remaining Including Descriptions of the Analytical
Method Used: Diazinon. (Unpublished study received Nov 2, 1956
under PP0110; CDL:090139-H)
173
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
MRID Citation
00061988 Gigger, R.P. (1956) Methods of Analysis for Diazinon. (Unpublished
study received Nov 2, 1956 under PP0110; submitted by Geigy
Chemical Corp., New York, N.Y. CDL:090139-1)
00064253 Ciba-Geigy Corporation (1963) [Residue of Diazinon on Lima Beans
and Sorghum]. (Compilation; unpublished study received Jan 17,
1964; Mar 20, 1964 under unknown admin, no.; CDL:00215-B)
00066159 Spawn Mate, Incorporated (19??) Residue Chemistry: Enviornmental
[sic] Chemistry. (Unpublished study received Nov 12, 1980 under
44277-1; CDL:243958-A)
00073372 U.S. National Institutes of Health (19??) Bioassay of Diazinon for
Possible Carcinogenicity. Bethesda, Md.: USNCI. (DHEW publi-
cation no. (NIH) 79-1392; National Cancer institute, Carcinogen-
esis Testing Program; published study; CDL:238513-A)
00079016 Harris, S.B.; Holson, J.F.; Fite, K.R.; et al. (1981) A Dose Range-
finding Teratology Study of Diazinon (CAS Number 333-41-5) in
New Zealand White Rabbits including a Positive Control Group
Administered 6-Aminonicotinamide: CGA/SAI 280007. (Unpublished
study, including submitter summary, received Aug 27, 1981 under
100-524; prepared by Science Applications, Inc., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:245728-A)
00079017 Harris, S.B.; Holson, J.F.; Fite, K.R.; et al. (1981) A Teratology
Study of Diazinon (CAS Number 333-41-5) in New Zealand White
Rabbits: CGA/SAI 281005. (Unpublished study, including submit-
ter summary, received Aug 27, 1981 under 100-524; prepared by
Scientific Applications, Inc., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:245728-B)
00086349 Ciba-Geigy Corporation (19??) Diazinon: Insecticide. Greens-
boro, N.C.: Ciba-Geigy. (Bulletin; also in unpublished submis-
sion received Jul 26, 1977 under 4581-EX-28; submitted by Penn-
walt Corp., Philadelphia, Pa.; CDL:233109-B)
00084599 Pennwalt Corporation (1979) Knox Out: 2FM Insecticide—Food
Handling Establishment Meat Residue Study: Project No. WT-11-79.
(Unpublished study received Oct 1, 1981 under 1H5324; CDL:
246019-C)
174
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
MRID Citation
00089442 Geigy Chemical Corporation (1957) Results of Tests on the Amount of
Residue Remaining Including Descriptions of the Analytical
Methods Used: [Diazinon]. (Compilation; unpublished study re-
ceived Sep 23, 1957 under PP0151; CDL:090177-A)
00089485 Geigy Chemical Corporation (1957) Results of Tests on the Amount of
Residue Remaining including Descriptions of the Analytical
Method Used: [Diazinon]. (Compilation; unpublished study re-
ceived Mar 5, 1958 under PP0172; CDL:090199-F)
00089632 Geigy Chemical Corporation (1959) Ultraviolet Procedure for Deter-
mination of Diazinon Residues. Method dated Jul 2, 1959. (Un-
published study received Jan 25, 1961 under PP0232; CDL:
090260-A)
00089633 Geigy Chemical Corporation (1959) [Diazinon Residues—Various
Crops], (Compilation; unpublished study received Jan 25, 1961
under PP0232; CDL:090260-B)
00089634 Rai, L.; Roan, C.C. (1957?) Residues of Diazinon in Milk, Meat,
and Related Tissues. Final rept. (Unpublished study receive
Jan 25, 1961 under PP0232; prepared by Kansas State Univ.,
Kansas Agricultural Experiment Station, Dept. of Entomology,
submitted by Geigy Chemical Corp., New York, N.Y.; CDL:090260-C)
00089801 Geigy Chemical Corporation (1956) [Diazinon Residues—Corn].
(Compilation; unpublished study received Apr 20, 1957 under
PP0138; CDL:090166-H)
00089803 Geigy Chemical Corporation (1956) [Diazinon Residues—Broccoli,
Cauliflower]. (Compilation; unpublished study received Apr
20, 1957 under PP0138; CDL:090166-J)
00090250 Geigy Chemical Corporation (1962) Results of Tests on the Amount of
Residue Remaining, Including Descriptions of the Analytical
Methods Used: [Diazinon]. (Compilation; unpublished study re-
ceived Mar 1, 1963 under PP0406; CDL:090439-C)
00090253 Geigy Chemical Corporation (1962) Results of Tests on the Amount
of Residue Remaining, Including Descriptions of the Analytical
Methods Used: [Diazinon]. (Compilation; unpublished study, in-
cluding published data, received Feb 27, 1963 under PP0403; CDL:
090437-B)
175
-------
MRID
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
Citation
00090254 Derbyshire, J.C.; Murphy, R.T. (1962) Diazinon residues in treated
silage and milk of cows fed powdered diazinon. Journal of
Agricultural and Food Chemistry 10(5):384-386. (Also in unpub-
lished submission received Feb 27, 1963 under PP0403; submitted
by Geigy Chemical Corp., New York, N.Y.; CDL:090437-C)
00090324 Geigy Chemical Corporation (1961) Results of Tests on the Amount of
Residue Remaining Including Descriptions of the Analytical
Methods Used: [Diazinon]. includes methods dated Dec 23, 1960
and Jan 6, 1961. (Compilation; unpublished study, including
published data, received Feb 19, 1963 under PP0328; CDL:
090355-C)
00090343 Geigy Chemical Corporation (1960) Results of Tests on the Amount
of Residue Remaining Including Descriptions of the Analytical
Methods Used. Includes Method dated Dec 23, 1960. (Compi-
lation; unpublished study received Jan 3, 1961 under PP0346;
CDL:090375-D)
00091499 Geigy Chemical Corporation (1963) [Residues of Diazinon in Sor-
ghum]. (Compilation; unpublished study, including nos. AG-A
599, AG-A 580, AG-A 546..., receive9d Oct 22, 1965 under 6F0482;
CDL:090541-B)
00091533 Mattson, A.M.; Solga, J. (1965) Analysis of Chicken Tissues for
Diazinon After Feeding Diazinon for Seven Weeks. (Unpublished
study received May 7, 1968 under 8F0686; submitted by Geigy
Chemical Co., Ardsley, N.Y.; CDL:091193-A)
00091534 Geigy Chemical Company (1966) [Diazinon Residues on Soybeans].
(Compilation; unpublished study, including AG-A 938 and AG-A
1234, received May 7, 1968 under 8F0686; CDL:091193-B)
00091537 Geigy Chemical Company (1967) Residue Report: Almonds. (Compi-
lation; unpublished study, including AG-A no. 1375, AG-A-22,
AG-A-81 ... , received May 7, 1968 under 8F0686; CDL:091193-F)
00094195 Ciba-Geigy Corporation (1961) [Residues of Diazinon in Tomatoes].
(Compilation; unpublished study received May 12, 1961 under
100-437; CDL:000220-A)
176
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
MRID Citation
00101149 Ciba-Geigy Corp. (1964) [Insecticide Residues on Grapes]. (Com-
pilation; unpublished study received Oct 7, 1964 under 100-460;
CDL:101158-C)
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)
00106977 Geigy Chemical Co. (1966) [Diazinon Residues in Peanuts and Other
Crops]. (Compilation; unpublished study received Mar 20, 1966
under 7F0535; CDL:090652-B)
00108980 Geigy Chemical Corp. (1957) Results of Tests on the Amount of
Residue Remaining Including Descriptions of the Analytical
Methods Used: [Diazinon]. (Unpublished study received May 27,
1957 under PP0157; CDL:090184-B)
00108982 Geigy Chemical Corp. (1958) Results of Tests on the Amount of Resi-
due Remaining Including Descriptions of the Analytical Methods
Used: [Diazinon]. (Unpublished study received Nov 24, 1958
under PP0198; CDL:090225-B)
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)
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)
00109043 Sachsse, K. (1963) Acute Inhalation Toxicity of Technical Diazinon
in the Rat: Project No. Siss 1679. (Unpublished study received
Oct 11, 1977 under 100-524; prepared by Ciba-Geigy Ltd., Switz.
submitted by Ciba-Geigy Corp., Greensboro, NC; CDL:232008-Y)
177
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
MRID Citation
00109994 Mattson, A. (1975) Diazinon for Pest Control in Food Handling Es-
tablishments Using Spot Treatments—Residues Observed and the
Analytical Method Used: Report No. GAAC-75046. (Unpublished
study received Aug 5, 1975 under 100-576; submitted by Ciba-
Geigy Corp., Greensboro, NC; CDL:223340-N)
00113281 Ciba-Geigy Corp. (1962) [Diazinon Residues in Different Types of
Clover]. (Compilation; unpublished study received Feb 23, 1966
under 100-472; CDL:101164-A)
00118019 Agchem (1982) Knox Out 2FM Insecticide—Drench Treatment: Fire
Ant Mounds: Project WT-9-82. (Unpublished study received Nov 5,
1982 under 4581-351; CDL:248817-A)
00118021 Agchem (1982) Hydrolysis Study—Knox Out 2FM Insecticide versus
Diazinon E.G.: Project No. WT-4-79. (Unpublished study re-
ceived Nov 5, 1982 under 4581-351; CDL:248818-B)
00118031 Keller, A. (1981) Degradation of ... Basudin in Aerobic Soil:
Project Report 37/81. (Unpublished study received Nov 5, 1982
under 4581-351; prepared by Ciba-Geigy, Ltd., Switz., submitted
by Agchem Div., Penwalt Corp., Philadelphia, PA; CDL:248818-L)
00118034 Burkhard, N. (1980) Leaching Characteristics of Aged 14C-Diazinon
(Basudin) Residues in Two Standard Soils: Project Report 09/80.
(Unpublished study received Nov 5, 1982 under 4581-351; pre-
pared by Ciba-Geigy, Ltd., Switz., submitted by Agchem Div.,
Pennwalt Corp., Philadelphia, PA; CDL:248818-0)
00118036 Coffin, D.; McKinley, W. (1964) The metabolism and persistence of
Systox, Diazinon, and Phosdrin on field-sprayed lettuce. Jour-
nal of the A.O.A.C. 47(4):632-640. (Also in unpublished sub-
mission received Nov 5, 1982 under 4581-351; submitted by
Agchem Div., Pennwalt Corp., Philadelphia, PA; CDL:248818-S)
00118393 Agchem (1982) Rainbow Trout Toxicity—Knox Out 2FM Insecticide Con-
centrations in Water: Union Carbide Environmental Service Report
11506-41-06. (Unpublished study received Nov 5, 1982 under
4581-351; CDL:248821-A)
178
-------
MRID
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
Citation
00120130 Beauchamp de Caloni, I.; Gonzalez, M. (1972) Appraisal on Roasted—
Grinded Coffee Samples [for Diazinon Residue Effect]. (Unpub-
lished study received on unknown date under 1F1153; prepared by
Univ. of Puerto Rico, Agricultural Experiment Station, Food
Technology Laboratory, submitted by Ciba Geigy Corp., Ardsley,
NY; CDL:090943-B)
00121283 Agchem (1982) Daphnia Magna Toxicity—Knox Out 2FM Insecticide
Concentrations in Water [Used for Union Carbide Environmental
Service Report 11506-41-08. (Unpublished study received
Dec 15, 1982 under 4581-335; CDL:249076-D)
00121727 Ciba-Geigy Corp. (1966) [Diazinon Residues in Bananas]. (Compi-
lation; unpublished study received Mar 7, 1967 under 7F0576 ;
CDL:092864-A)
00123752 Ciba-Geigy Corp. (1973) Diazinon—Guar. (Compilation; unpublished
study received Jun 26, 1973 under 3F1415; CDL:093783-A)
00125078 Ciba-Geigy Corp. (1956) [Diazinon Residues—Beets]. (Compilation;
unpublished study received Feb 7, 1958 under PP0157; CDL:
092434-A)
00125096 Ciba-Geigy Corp. (1959) [Residues: Diazinon]. (Compilation;
unpublished study received 1959 under PP0198; CDL:092474-A)
00125542 Ciba-Geigy Corp. (1960) [Residues: Diazinon]. (Compilation;
unpublished study received 1960 under PP0232; CDL:092509-A)
00125557 U.S. Agricultural Research Service (19??) Procedure for the Deter-
mination of Phosphorous in Fat. (Unpublished study received
Mar 1, 1963 under 3F0406; submitted by Ciba-Geigy Corp., Greens-
boro, NC; CDL:092694-E)
00125620 Ciba-Geigy Corp. (1972) [Study of the Residue of Diazinon in
Coffee]. (Compilation; unpublished study received May 24, 1972
under 1F1153; CDL:093468-B)
00127229 Ciba-Geigy Corp. (1961) [Residues: Diazinon]. (Compilation; unpub-
lished study received Mar 8, 1966 under 6F0482; CDL:092771-A)
00129308 Crown Zellerbach Corp. (1983) Results of Tests on the Amount of
Residue Remaining and Description of the Analytical Methods
Used: Unpublished compilation; 128 p.
179
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
MRID Citation
00109994 Mattson, A. (1975) Diazinon for Pest Control in Food Handling Es-
tablishments Using Spot Treatments—Residues Observed and the
Analytical Method Used: Report No. GAAC-75046. (Unpublished
study received Aug 5, 1975 under 100-576; submitted by Ciba-
Geigy Corp., Greensboro, NC; CDL:223340-N)
00131006 Ciba-Geigy Corp. (1982) [Study—Residue: Diazinon/14G and AG500 on
Grass and Thatch]. (Compilation; unpublished study received Sep
2, 1983 under 100-461; CDL:251138-J)
00132952 Simmon, V. (1979) In vitro Microbiological Mutagenicity and Un-
scheduled DNA Synthesis Studies of Eighteen Pesticides: Contract
No. 68-01-2458. (Unpublished study received Dec 5, 1983 under
239-2471; prepared by SRI International, submitted by Chevron
Chemical Co., Richmond, CA; CDL:251894-F)
00135470 Geigy Chemical Corp. (19??) Ultraviolet Procedure for Determination
of Diazinon Residues: [Data on Fruits and Vegetables]. (Unpub-
lished study received 1959 under PP0198; submitted by Ciba-Geigy
Corp., Greensboro, NC; CDL:098540-A)
00135471 Ciba-Geigy Corp. (1965) [Residue of Diazinon in Chickens]. (Compi-
lation; unpublished study received 1965 under PP0406; CDL:
098544-A)
00135716 Ciba-Geigy Corp. (1977) Residues of Diazinon in or on Wheat Straw
and Grain Treated with Foliar Applications of Diazinon. (Comp-
ilation; unpublished study received Apr 13, 1977 under 7G1946;
CDL:096089-A)
00140118 Interregional Research Project No. 4 (1978) The Results of Tests on
the Amount of Diazinon Residue Remaining in or on Mushrooms
Including a Description of the Analytical Method Used. (Comp-
ilation; unpublished study received Apr 17, 1978 under 8E2071;
CDL:097028-A)
00142045 Vigfusson, N.; Vyse, E.; Persteiner, C.; et al. (1983) In vivo in-
duction of sister-chromatid exchange in Umbra limi by the insec-
ticides endrin, chlordone, diazinon and guthion. Mutation Re-
search 118:61-68.
00146179 Nissimov, S. (1984) Diazol Tech Acute Oral Toxicity in the Rat: Re-
port No. MAK/063/DZL/TECH. Unpublished study prepared by Life
Science Research Israel Ltd. 21 p.
180
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
MRID Citation
00146180 Nissimov, S. (1984) Diazol Tech Acute Dermal Toxicity in Rabbits:
Report No. MAK/064/DZL/TECH. Unpublished study prepared by Life
Science Research Israel Ltd. 12 p.
00148695 Balcomb, R.; Stevens, R.; Bowen, C. (1984) Toxicity of 16 granular
insecticides to wild-caught songbirds. Bulletin of Environmen-
tal Contamination and Toxicology 33:302-307.
00148703 Hill, E.; Camardese, M. (1984) Toxicity of anticholinesterase in-
secticides to birds: Technical grade versus granular formula-
tions. Ecotoxicology and Environmental Safety 8:551-563.
00153017 Infurna, 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.
00153231 Martinson, J. (1985) Photodegradation of :Carbon-14:-Diazinon in
Water: Final Report: Biospherics Project No. 85-E-044 PW. Un-
published study prepared by Biospherics Inc. 90 p.
00162751 Stevenson, J. (1968) Laboratory studies on the acute contact and
oral toxicities of insecticides to honeybees. Ann. appl. Biol.
61:467-472.
05003978 Bartlett, B.R. (1963) The contact toxicity of some pesticide
residues to hymenopterous parasites and coccinellid predators.
Journal of Economic Entomology 56(5):694-698.
05004148 Bartlett, B.R. (1964) The toxicity of some pesticide residues to
adult Amblyseius hibisci:, with a compilation of the effects
of pesticides upon phytoseiid mites. Journal of Economic
Entomology 57(4):559-563.
05005640 Bartlett, B.R. (1966) Toxicity and acceptance of some pesticides
fed to parasitic Hymenoptera and predatory coccinellids.
Journal of Economic Entomology 59(5):1142-1149.
181
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
MRID Citation
05005830 Matthysse, J.G.; Lisk, D. (1968) Residues of diazinon, coumaphos,
Ciodrin, methoxychlor, and rotenone in cow's milk from
treatments similar to those used for ectoparasite and fly
control on dairy cattle, with notes on safety of diazinon and
Ciodrin to calves. Journal of Economic Entomology
61(5):1394-1398.
05009345 Croft, B.A.; Nelson, E.E. (1972) Toxicity of apple orchard
pesticides to Michigan populations of Amblyseius fallacis:.
Environmental Entomology 1(5):576-579.
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 Incorpora-
ted. 77 p.
40094602 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates: Resource Publi-
cation 137. US Fish and Wildlife Service, Washington, D.C.
106 p.
40101501 Das, Y. (1987) Diazinon Anaerobic Aquatic Soil Metabolism: Labora-
tory Study No. 85E044AM-ANAEROBIC. Unpublished study prepared
by Biospherics Inc. 94 p.
40202901 Maddy, K. (1984) Degradation of Dislodgeable Residues of Chlorpyri-
fos and Diazinon on Turf: A Preliminary Survey: Laboratory Study
No. HS-1196. Unpublished study prepared by California Depart-
ment of Food and Agriculture. 15 p.
40202902 Maddy, K. (1985) Degradation of Dislodgeable Diazinon Residue on
Chinese Cabbage and Broccoli Foliage in Santa Barbara and San
Luis Obispo Counties: Laboratory Study No. HS-1273. Unpublished
study prepared by California Department of Food and Agriculture.
12 p.
40202903 Maddy, K. (1985) Degradation Study for Dislodgeable Diazinon Resi-
due on Head Lettuce and Chinese Cabbage Foliage in Monterey and
Santa Cruz Counties: Laboratory Study No. HS-1271. Unpublished
study prepared by California Department of Food and Agriculture.
15 p.
182
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
MRID Citation
40466601 Merricks, D. (1987) Diazinon Dislodgeable Residue Study: Agrisearch
Project No. 1279. Unpublished study prepared by Agrisearch,
Inc. 95 p.
40509804 Canez, V. (1988) Nontarget Phytotoxicity Test: Vegetative Vigor:
Tier 1: Diazinon MG-8: Laboratory Study No. LR87-37A. Unpub-
lished 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 Labo-
ratories, Inc. 151 p.
40509806 Hughes, J. (1988) The Toxicity of Diazinon Technical to Selenastrum
capricornutum: Diazinon Technical: Laboratory Study No. 0267-40-
1100-1. Unpublished study prepared by Malcolm Pirnie, Inc. 122
P.
40512601 Spare, W. (1987) Leaching Characteristics of Diazinon. Agrisearch
Project No. 1293. Unpublished study prepared by Agrisearch,
Inc. 90 p.
40910901 Beavers, J. (1987) Eight-Day Dietary LC50 - Mallard Duck: Knox
Out 2FM: Final Report. Project No. 110-120. Prepared by
Wildlife Intl. Ltd.; submitted by Pennwalt Corp. 3 p.
409109201 Beavers, J. (1987) Eight-Day Dietary LC50 - Bobwhite Quail:
Knox Out 2FM: Final Report. Project No. 110-121. Prepared
by Wildlife Intl. Ltd.; submitted by Pennwalt Corp. 3 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.
40910905 Hill, E. ; Camardese, M. (1986) Knox Out 2FM Insecticide - Simulated
Avian Field Study, Project No. Wl-2-79. Prepared and submitted b
Pennwalt Corp. 15 p.
183
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diazinon Standard
MRID Citation
40914801 Goodman, L.; Hansen, D.; Coppage, D.; et al. (1979) Diazinon
Chronic Toxicity to, and Brain Acetylcholinesterase In-
hibition in, the Sheepshead Minnow, Cyprinodon variegatus.
Trans. Amer. Fisher. Soc. 108:479-488.
40922901 Fletcher, D. (1987) 14-Day Acute Oral Toxicity study with Diazinon
MG8 in Mallard Ducks: Final Report: Laboratory Project ID:
BLAL 87 DD 48. Unpublished study prepared by Bio-Life
Associates, Ltd. 41 p.
40922902 Fletcher, D. (1987) 14-Day Acute Oral Toxicity study with Diazinon
MG8 in Mallard Ducks: Final Report: Laboratory Project ID:
BLAL 87 DD 48. Unpublished study prepared by Bio-Life
Associates, Ltd. 41 p.
184
-------
V. FORMS APPENDICES
185
-------
EPA Form 8580-1
OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3 cincelletion of the rijinntiqn of thu prpdua (Thu option a not tvtiUBH to ipplonu for rM* produru.)
AUTHOMIZEO MPAESINTATIVE
DATE
186
-------
EPA Form 8580-6
OMB Approval No. 2070-0057
Expires 11/30/89
(To ouftify. certify ALL four ittmt)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(t) who are subject to (he require-
ments of i Notice under FIFRA Section 3(cl(2)<8) contained in » Guidance Document
to uibmit ant concerning the act
-------
OMB Approval No.
2070-005
Expires 11/30/89
ERA Reg. No..
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
Subpart C
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
inaredients
Statement of
composition
Discussion of
formation of
inoredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
,_ Physical state _,
Odor
Melting point
Boilinq point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
I am complying
data requiremc
Citing MRID
Number or
EPA Accession
Number
j with
aits by
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
EPA Form 8580-4
188
-------
OMB Approval No.
2070-005
Expires 11/30/89
PRODUCT SPECIFIC DATA REPORT (cont'd)
EPA Reg. NO..
Date
Guidance Document for_
Registration
Guideline No.
Subpart C
PRODUCT
CHEMISTRY
(cont'd)
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.340
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Name of Test
Stabilitv
Oxidi z ing/reduc ing
reaction
Flammabilitv
Explodabi 1 i tv
Storaae stability
Viscosity
Miscibilitv
Corrosion
characteristics
Dielectric break-
down voltaae
Acute oral
toxic ity. rat
Acute dermal
toxicitv. rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion.
Acute Delayed
neurotoxicitv, hen
Test not
required
for my
product
listed
above
(check
below)
I am complyinc
data requireme
Citing MRID
Number or
EPA Accession
Number
j with
aits bv
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
EPA Form 8580-4 (cont'd)
189
-------
OMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified above, I
certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the active
ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product, despite
our lack of intent to submit the generic data in question, on the grounds that the product
contains the active ingredient solely as the result of the incorporation into the product
of another product which contains that active ingredient, which is registered under FIFRA
Section 3, and which is purchased by us from another producer.
(3) An accurate Confidental statement of Formula (CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by company name,
registration number, and product name, the source of the subject active ingredient in my
firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form 8570-4. The registered
source(s) of the above named active ingredient in my product(s) is/are
and their registration number (s) is/are ,.
My firm will apply for an amendment to the registration prior to changing the source
of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any portion of
this Statement is no longer true, or if my firm fails to comply with the undertakings made
in this Statement, my firm's product's registration may be suspended under FIFRA Section
3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption for the
product, my firm relies on the efforts of other persons to provide the Agency with the
required generic data, if the registrant(s) who have committed to generate and submit the
required data fail to take appropriate steps to meet requirements or are no longer in
compliance with this Notice's data requirements, the Agency will consider that both they
and my firm are not in compliance and will normally initiate proceedings to suspend the
registrations of my firm's product(s) and their product(s), unless my firm commits to
submit and submits the required data in the specified time frame. I understand that, in
such cases, the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature
Dated:
(Typed)
EPA Form 8580-3
190
------- |