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Environirwntal Protection
Ao»ncy
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Pwtiekta* and Toxic SutManeM
WMhingtenDC 20460
540/RS-88-081
September 1988
PtMicidw
Guidance for the
Reregistration of
Pesticide Products
Containing HEXAZINONE
as the Active Ingredient
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OMB Control No. 2070-0057
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
HEXAZINONE
AS THE ACTIVE INGREDIENT
CASE NUMBER 0266
CAS (DOCKET) NUMBER 107201
SEPTEMBER 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by this Standard ' 3
A. Description of Chemical
B. Use Profile
C. Background
III. Agency Assessment 5
A. Toxicological Assessment
B. Other Science Findings
C. Tolerance Reassessment
IV. Regulatory Assessment 16
A. Regulatory Positions and Rationales
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 23
VI. Requirement for Submittal of Generic Data 25
A. What are generic data? 25
B. Who must submit generic data? 25
C. What generic data must be submitted? 26
D. How to comply with DCI requirements 26
E. Registrant Requests Regarding Data
Requirements and Agency Responses 29
F. Test Protocols and Standards 29
G. Procedures for requesting a change in protocol ... 30
H. Procedures for requesting extensions of time 30
I. Data Format and Reporting Requirements 30
J. Existing stocks provisions upon suspension or
cancellation 31
VII. Requirement for Submittal of Product-Specific Data 31
VIII. Requirement for Submittal of Revised Labeling 32
IX. Instructions for Submittal 32
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
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APPENDICES
I. DATA APPENDICES
Guide to Tables 37
Table A 39
TableB 39
II. LABELING APPENDICES
Summary of label requirements and table 65
40 CFR 156.10 Labeling Requirements 73
Physical/Chemical Hazards Labeling Statements 85
Storage Instructions 86
Pesticide Disposal Instructions 87
Container Disposal Instructions 88
III. BIBLIOGRAPHY APPENDICES
Guide to Bibliography 90
Bibliography 92
IV. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet 98
EPA Form 8580-3 Generic Data Exemption Statement 99
EPA Form 8580-4 Product Specific Data Report 100
EPA Form 8580-6 Certification of Attempt to Enter
Into an Agreement with Other
Registrants for Development of Data ... 102
ii
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
a.i. active ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated
pesticide concentration in an environment, such as a
terrestrial ecosystem.
EP End Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
LC50 Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
LD50 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, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g.,
mg/kg.
LEL Lowest Effect Level
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
MP Manufacturing Use Product
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
iii
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OES Office of Endangered Species, U.S. Fish and Wildlife
Service
PADI Provisional Acceptable Daily Intake
ppm parts per million
RfD Reference Dose
TMRC Theoretical Maximal Residue Contribution
IV
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I. INTRODUCTION
This document is a revised Registration Standard for the
subject chemical. In its original Standard, issued in February
1982 the Agency described the available data supporting the regis-
tration of the chemical. The Agency concluded that additional
data were necessary to fully evaluate the pesticide. The
Agency also set out label language which the Agency concluded
at that time were needed to ensure that products containing
the pesticide remained in compliance with FIFRA.
The Agency has since received and reviewed the additional
data and has revised its scientific and regulatory conclusions
in light of those data, other information on the chemical,
and expanded data requirements promulgated in 1984, at 40 CFR
Part 158, for registration and reregistration of pesticides
under FIFRA.
This revised Registration, which supersedes the earlier
Standard, is the Agency's updated scientific assessment of
the pesticide, and the data needed to support its continued
registration. The Agency has also reassessed the tolerances
for the pesticide; that reassessment is included in this
Registration Standard.
The Agency has also reviewed the current labeling for
products containing the pesticide, and has specified label
revisions which are necessary to remain in compliance with
FIFRA.
The detailed scientific review, which is not contained
in this document, but is available upon request1, focuses on
the pesticide active ingredient. The scientific review pri-
marily 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 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
1The scientific reviews and Compendium of Uses may be obtained
from the National Technical Information Service (NTIS),
Attn: Order Desk, 5285 Port Royal Road, Springfield, VA
22161. Tel: (703) 487-4650.
,:
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steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission 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 unreason-
able 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 submission of completed studies called in by the
Agency and continues as long as the products are registered
under FIFRA.
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II. CHEMICAL COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICAL
The following chemical is covered by this Registration
Standard:
Common Name: Hexazinone
Chemical Name: 3-cyclohexyl-6-dimethylamino-l-methyl-l,3,5-
triazine-2,4(lH,3H)-dione
Chemical Family: Triazines
CAS Registry Number: 51235-04-02
OPP (Shaughnessy) Number: 107201
Empirical Formula: C12H20N4°2
Trade Name: Velpar
Physical Characteristics: White Crystalline Solid
Molecular Weight: 252.3
Melting Point: 115-117 °C
Solublity: g/100 g solvent
at 25 °C:
3.3 Water
388 Chloroform
265 Methanol
94 Benzene
83.6 Dimethylformamide
79.2 Acetone
38.6 Toluene
0.3 Hexane
Odor: Negligible
Vapor Pressure: 2 x 10~7
mmHg, 25 °C
Octanol/Water Partition
Coefficient: 11.3
Specific Gravity: 1.25
Stability: Stable in aqueous
solutions at pH 5, 7, 9, at
temperatures up to 37 °C
B. USE PROFILE
Type of Pesticide: Hexazinone is a selective, triazine
herbicide that is used to control grasses and broadleaf and
woody plants.
Mechanism of Action: Hexazinone acts as a photosynthesis
inhibitor. It is translocated primarily upward through the
xylem tissues of the plant. It is readily absorbed through
foliage and roots and usually shows a high degree of contact
activity.
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Registered Uses:
Terrestrial Food Crop use on alfalfa (including seed
crop), fruit (blueberry, pineapple), sugarcane, pastures,
rangeland, and fallowland.
Terrestrial nonfood crop use on bahiagrass and bermuda-
grass, noncrop areas (rights-of-ways, petroleum tank farms,
storage areas, and industrial plant sites).
Aquatic nonfood crop use on drainage ditch banks.
Forestry use on Christmas tree plantations, conifers
(nursery), conifer release and forest plantings.
Predominant Uses: Hexazinone use estimates are 33 percent on
alfalfa, 31 percent in forestry, 29 percent in industrial
areas, 4 percent on rangeland and pastures, and < 2 percent
on sugarcane.
Formulations: Hexazinone is formulated as a technical, formula-
tion intermediate, granular, pelleted/tableted, dry flowable,
emulsifiable concentrate, soluble concentrate/liquid and
ready-to-use liquid.
Methods of Application: Hexazinone may be applied either
postemergence, preemergence, layby, directed spray, or basal
soil treatment using ground equipment or where appropriate,
broadcasted by aerial equipment.
Rates of Application:
Terrestrial food crop - 0.22 - 6.0 Ib ai/A
Terrestrial nonfood crop - 0.67 - 13.5 Ib ai/A
Aquatic nonfood crop - 1.0 - 13.5 Ib ai/A
Forestry - 0.45 - 6.0 Ib ai/A
C. BACKGROUND
Hexazinone was Federally registered in November 1975 for
general weed control in noncropland areas. Uses in Christmas
trees, reforestation areas, and woody plants were added in 1977.
Sugarcane and alfalfa uses were added in 1980 and 1981,
respectively. A Registration Standard for hexazinone was issued
in February 1982. That document identified data gaps according
to regulations then in place. After issuance of the 1982 Standard,
new uses for hexazinone were established on blueberries, rangeland,
pasture grasses, and pineapple. This document is a reevaluation
of earlier studies and of those studies submitted since the
issuance of the first Standard.
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III. AGENCY ASSESSMENT
A. TOXICOLOGICAL ASSESSMENT
• This section discusses data available to the Agency for the
toxicological evaluation of hexazinone.
ACUTE TOXICITY STUDIES
Acute Oral
There was one acceptable study in male rats. An additional
study in females is required. The oral LD5Q of hexazinone
technical was 1690 mg/kg for male Charles River CD rats with
95 percent confidence limits of 1560 to 1880 mg/kg. The study
was classified as Core-Supplementarv, Toxicity Category III,
since females were not tested.
Acute Dermal
There was one acceptable study in male rabbits. An
additional study in females will be required if the acute oral
study indicates a sex difference or that females may be more
sensitive than males. The dermal LD5Q of hexazinone technical
for male New Zealand White rabbits was greater than 5278 mg/kg.
There were no deaths. The only toxic sign was mild erythema in
one rabbit, which cleared by 24 hours. The study was classified
as Core-Supplementary, Toxicity Category IV, since females were
not tested.
Acute Inhalation
There was one acceptable study in male rats. An additional
study in females will be required if the acute oral study indi-
cates a sex difference or that females may be more sensitive than
males. The acute inhalation LCcg of hexazinone technical in
male Charles River CD rats for 1 hour of exposure was greater
than 7.48 mg/L (gravimetric determination). There were no deaths.
The toxic signs were salivation and irregular respiration. The
study was classified as Core-Supplementary, Toxicity Category
III, since females were not tested.
Primary Eye Irritation
There was one acceptable study. No additional studies are
required. Nine rabbits received 0.1 mL of hexazinone technical
in one eye each. The treated eyes of three of the rabbits were
washed 20 seconds posttreatment. Observations were made at 1,
2, 3, 4, 7, 14, 21, and 28 days. At day 1, 6/6 animals of the
unwashed group and 3/3 of the washed group had corneal opacity;
5/6 (unwashed) and 3/3 (washed) had iris irritation; 6/6
(unwashed) and 3/3 (washed) had conjunctivae redness, chemosis,
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and discharge. At day 7, 6/6 (unwashed) and 1/3 (washed) had
corneal opacity; 2/6 (unwashed) iris irritation; 6/6 (unwashed)
redness, chemosis, and discharge. At day 14, 4/6 (unwashed) and
1/3 (washed) had corneal opacity. At day 21, 4/6 (unwashed) had
corneal opacity. At day 28, 4/6 (unwashed) had corneal opacity.
The study was classified as Core-Guideline, Toxicity Category I.
Hexazinone is considered to be corrosive, causing irreversible
eye damage.
Primary Dermal Irritation
There was one acceptable study. No additional studies are
required. Six rabbits received 0.5 g of hexazinone technical at
two intact and two abraded skin sites per animal under occlusive
wrap for 24 hours exposure. Observations were made at the end of
the 24-hour exposure period and 2, 3, and 4 days after treatment.
At 24 hours, 6/6 had erythema and 5/6 had edema. At 3 days, 3/6
had erythema and 1/6 had edema. The range of Primary Irritation
Score was 0.50 to 1.50 (rating range is 0 - 4 (4 being severe)).
The study was classified as Core-Guideline, Toxicity Category IV.
Dermal Sensitization
There was one unacceptable study in male guinea pigs. There
was no skin irritation (erythema) on test sites. The study was
classified as Core-Supplementary because the study design was
inadequate and no positive control group was run. A repeat study
is required.
SUBCHRONIC TOXICITY STUDIES
There were two acceptable studies reviewed. One study was
in the rat and the other study was in the dog. No additional
oral studies are required. A 21-day dermal study is required.
Sprague-Dawley (ChR-CD) albino rats were fed dietary levels
of 0, 10, 50, and 250 mg/kg/day of hexazinone technical for 3
months. Criteria evaluated included toxic signs, body weight,
food consumption, hematology, clinical chemistry, urinalysis,
organ weights, and histopathology. The no observed effect level
(NOEL) for the 90-day feeding study was 50 mg/kg. At the lowest
effect level (LEL) of 250 mg/kg (highest dose tested (HOT)), there
were decreased body weights in males (7%) and females (15%) in
comparison to controls. There were no compound-related effects
in mortality, toxic signs, food consumption, clinical pathology,
organ weights, and histopathology. The study was classified as
Core-Minimum.
In the dog study, beagle dogs 10 to 18 months of age, were fed
dietary levels of 0, 5, 25, and 125 mg/kg/day of hexazinone
technical for 3 months. Criteria evaluated included toxic signs,
body weight, food consumption, hematology, clinical chemistry,
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urinalysis, organ weights, and histopathology. The NOEL was 25
mg/kg. At the LEL of 125 mg/kg (HOT), there was decreased body
weight in"both sexes/ increased alkaline phosphatase in both
sexes, decreased albumin/globulin values in both sexes, and
increased absolute and relative liver weight in both sexes.
There were no compound-related histopathological effects. The
study was classified as Core-Minimum.
CHRONIC ORAL TOXICITY
One acceptable chronic feeding study in rats was submitted
for technical hexazinone. This study was reviewed as a combined
chronic toxicity/oncogenicity study. A data gap exists for a
chronic nonrodent (dog) feeding study and the Agency is requiring
submission of a dog study.
The combined chronic toxicity/oncogenicity rat feeding study
was accepted as core-minimum data. Sprague-Dawley rats were fed
dietary levels of 0 (control), 10, 50, and 125 mg/kg/day of
hexazinone technical for 2 years. Criteria evaluated included
toxic signs, morbidity, mortality, body weight, food consumption,
hematology, urinalysis, biochemistry, organ weights, and histopath-
ology. Statistical methods were not presented in the report.
There was increased survival over all test groups for male
rats at 125 mg/kg at 2 years. The percent survival for male rats
at 2 years was 31, 47, 39, and 69 percent for combined controls
and low-, mid-, and high-dose groups, respectively. Survival at
2 years in female rats was comparable between control and treated
groups. The systemic NOEL was 10 mg/kg. At the LEL of 50 mg/kg,
females had a 5 percent decreased body weight and a slight decrease
in food efficiency. At 125 mg/kg, there were significant toxic
effects in both sexes. Males had a 12% body weight decrease,
a 4% food consumption decrease, increased white blood cells and
eosinophiles, alkaline urine and organ weight changes. Females
had a 19% body weight decrease, slight food efficiency decrease,
alkaline urine and organ weight changes.
ONCOGENICITY
One oncogenicity study in mice with technical hexazinone
has been submitted. Additionally, an acceptable rat oncogencity
study was submitted as part of a combined chronic toxicity/
oncogenicity study. No additional oncogenicity studies are
required at this time. A repeat mouse study, however, may be
required at a later time.
In the combined chronic toxicity/oncogenicity rat feeding
study (see Chronic Toxicity section above for details of the study),
the oncogenic potential was negative up to and including 125
mg/kg (HOT). This dosage level was considered to be a maximum
tolerated dose (MTD).
In the mouse study, CD-I mice were fed diets containing 0,
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30, 375, and 1500 mg/kg/day of technical hexazinone for 2 years.
Criteria evaluated include toxic signs, morbidity, mortality,
body weight, food consumption, hematology, organ weights, and
histopathology.
The results of the mouse study were inconclusive due to a
possible ambiguity in the classification of liver neoplasia
(hyperplastic nodules). The systemic NOEL is 30 mg/kg. At the
LEL of 375 mg/kg, there were increases in toxic signs, decreased
body weight of both sexes, and increased histological effects in
the livers of male mice. The 1500 mg/kg (HOT) level was the MTD
because there were significant body weight decreases in both
sexes, increased food consumption in both sexes, increase in mean
absolute and relative liver weight in males, and increase in mean
relative liver weight in females. Histologically, there were
increased incidence of hepatocellular hypertrophy, focal necrosis,
and hyperplastic nodules in male mice and hepatocellular hypertrophy
in female mice. All control, low-, mid-, and high-dose group
liver slides for both sexes are to be submitted to EPA for additional
histopathological evaluation. This study is classified as Core-
Supplementary pending Agency review of the slides.
Hexazinone's oncogenic potential will be reassessed based
on all data on file with the Agency when the review of the slides
from the mouse study is completed.
TERATOGENICITY
Three teratology studies were submitted. Two were in rats
(one by gavage and one by diet) and the third was in rabbits (by
gavage). There are no additional teratology studies required.
In the rat gavage study, Sprague-Dawley rats were administered
technical hexazinone once daily by gavage, on days 7 to 16 of
gestation, at doses of 0, 40, 100, 40'0, and 900 mg/kg/day. Ante-
mortem criteria evaluated included toxic signs, morbidity, mor-
tality, body weight, and food consumption. On gestation day 22,
all remaining dams were sacrificed by C02 inhalation and examined
grossly. Reproductive parameters, the weight of the liver, and
gravid uterus were determined. Fetuses were sexed and examined
for external, visceral, and skeletal abnormalities.
At 900 mg/kg/day (HOT), developmental toxicity was evidenced
as decreased fetal body weight of both sexes, increased incidence,
of fetuses with kidney anomalies, and an increased percentage of
fetuses with retarded development (partial ossification). The
NOEL for developmental toxicity was 100 mg/kg/day. At the LEL of
400 mg/kg/day, there was decreased female fetal body weight,
marginally increased kidney anomalies, and increase in unossifie,d
sternebrae in fetuses.
The NOEL for maternal toxicity was 100 mg/kg/day. At the
LEL of 400 mg/kg/day, there was decreased food consumption,
increased relative liver weight, decreased body weight gain, and
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increased incidence of clinical signs. The study was classified
as Core-Guideline.
In the rat dietary study, pregnant Sprague-Dawley rats were
fed diets containing 0, 10, 50, and 250 mg/kg/day of hexazinone
technical during days 6 to 15 of gestation. On day 21 of gestation,
all dams were sacrificed by chloroform inhalation. Reproductive
parameters were determined. Fetuses were sexed and examined for
external, visceral, and skeletal abnormalities.
The developmental toxicity potential was negative up to
250 mg/kg (HOT) in the diet during days 6 to 15 of gestation. The
NOEL for maternal toxicity was 50 mg/kg. At the LEL of 250 mg/kg,
there was decreased body weight and increased incidence of partial
resorptions in treated dams. The study was classified as Core-
Supplementary since individual animal data were not provided and
the study design was inadequate (test material administered in
feed rather than by gavage).
In the rabbit study, New Zealand White rabbits were gavaged
dailey with 0, 20, 50, and 125 mg/kg/day of technical hexazinone
from day 6 through 19 of gestation. On day 29 of gestation, all
surviving does were sacrificed. Reproductive parameters were
recorded. Fetuses were examined for external, visceral, and
skeletal abnormalities.
The NOEL for developmental toxicity was 50 mg/kg/day. The
LEL was 125 mg/kg/day (HOT) and the effects were decreased fetal
body weight and increased delayed ossification of skeletal
extremities in fetuses. The maternal NOEL was 50 mg/kg/day. At
the LEL of 125 mg/kg/day, there was decreased body weight,
increased resorptions, and increased clinical signs. The study
was classified as Core-Minimum.
REPRODUCTION
The Agency has reviewed one three-generation reproduction
study in rats. Sprague-Dawley rats were fed dietary levels of 0,
10, 50, and 125 mg/kg/day of hexazinone technical through three
generations with one litter per generation. The NOEL was 50 mg/
kg/day. The LEL was 125 mg/kg/day (HOT) and the effect was
decreased average weight of weanlings (day 21) in the F2a and F3a
litters. There were no compound-related effects in fertility,
gestation, viability, and lactation indices in the F^a, F2a, and
F33 litters. The study classification was Core-Supplementary. The
deficiencies included (1) incomplete Material and Methods sections,
(2) insufficient Summary Tables, (3) Clinical Observations data
not provided, and (4) necropsy, organ weights, pup histopathology
data, and statistical analyses data not provided. This study may
be upgraded if a more complete report can be submitted.
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MUTAGENICITY TESTING
An acceptable battery of mutagenicity studies has been
submitted. No additional mutagenicity studies are required.
Hexazinone has been determined as not a mutagen.
Gene Mutation
There was one acceptable gene mutation study in bacteria.
Hexazinone technical was evaluated both with and without S-9
in five histidine-requiring strains of J5. typhimurium at concen-
trations of 0, 400, 800, 1200, 1600, or 2000 ucj/plate with acti-
vation and at concentrations of 0, 200, 400, 800, or 1000 u_g/plate
without activation. Positive controls were employed. The technical
grade product was not mutagenic under conditions of the assay.
Chromosomal Aberration
The Agency has reviewed two chromosomal aberration assays
both of which are acceptable. The first study evaluated hexazinone
technical in vitro in the Chinese hamster ovary cells system both
with and without S-9 treatment at dosages up to 19.82 mM without
S-9 and up to 15.85 mM with S-9. Appropriate negative and positive
controls were evaluated concurrently. Without S-9", hexazinone
technical was positive at 15.85 mM.
In the second study, hexazinone technical was administered as
a single oral dose to male and female Sprague-Dawley rats at 100,
300, and 1000 mg/kg. Positive controls were evaluated concur-
rently. Bone marrow was extracted from the femurs of each animal
and slides of cells were prepared. The technical grade product
did not induce chromosomal aberrations under the conditions of
the assay.
Direct DNA Damage
Hexazinone technical was evaluated for unscheduled DNA
synthesis at dosages ranging from 1 x 10~5 to 30 mM in primary
rat hepatocytes obtained from the livers of 8-week-old Sprague-
Dawley rats (200-300 g). Unscheduled DNA "repair" synthesis,
evidenced by a net increase in black silver grains over the
nucleus, was not increased by hexazinone technical. The study
was acceptable.
METABOLISM
&
The Agency has reviewed one acceptable rat metabolism study.
c!4_iabeled hexazinone was used in the study. Three groups of
male and female Sprague-Dawley rats were used. The rats received
(a) a single 14 mg/kg dose of C14-hexazinone without precondi-
tioning; (b) a single 14 mg/kg dose of C14-hexazinone (14 mg/kg)
following a 3-week preconditioning period with 100 ppm cold hexa-
zinone in the diet: and (c) a single high dose (1000 mg/kg) of
Cl4-hexazinone without preconditioning. After dosing, the rats
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were placed in individual metabolism cages. Urine and feces were
collected, blood was drawn by cardiac puncture at sacrifice, and
tissues were removed.
C14-hexazinone was excreted as an average of 97 percent of the
total dosed radioactivity via the urine (ca. 77%) and feces (ca.
20%) during the collection period and the results were comparable
for each treatment regimen. Very low levels of radioactivity
(ca. 0.2%) were detected in the GI tract, hide, excised organs,
muscle, blood, and fat. Hexazinone was metabolized primarily by
hydroxylation and demethylation resulting in eight major metabolites.
No additional data are required.
HUMAN EXPOSURE
Hexazinone has not been reported to be associated with any
death or hospitalized cases, either in national surveys or in
California. In California, where physician-treated, occupational
poisonings are reported, there have been no poisonings due to
hexazinone since 1976. The voluntary accident reportings system
(PIMS, Report Number 409, 1981) reported one accidental ingestion.
Protective clothing - Technical grade hexazinone is corrosive
to the eye and causes irreversible eye damage. Use of protective
goggles, face shield, or safety glasses are required for mixers,
loaders, and applicators.
Reentry - Reentry data are not required. These data are
required only when both the toxicity and the exposure criteria of
40 CFR 158.140 are met. Hexazinone is registered for use on
blueberries, pineapples, and Christmas trees which are crops that
require hand labor. However, hexazinone would not normally be
applied either to the foliage of these crops or just prior to
hand labor operations. Agency has not received adequate toxicological
or epidemiological evidence that residues of hexazinone can cause
adverse effects on persons entering treated sites.
B. OTHER SCIENCE FINDINGS
ENVIRONMENTAL FATE
Environmental fate data show that hydrolysis is not an
important degradation pathway for hexazinone (less tha 20 percent
of parent material had decomposed after an 8-week period, in the
environmentally significant pH range 5 to 9).
While the photodegradation in water studies were not acceptable,
there is indication that the presence photosensitizers contribute
to the photodegradation of hexazinone. Studies must be performed
using the full spectrum of natural sunlight. However, the major
decomposition pathway for hexazinone appears to be microbial
degradation.
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Hexazinone is structurally related to triazine pesticides
that are known to contaminate groundwater. While the mobility
studies reviewed for this document are unacceptable they do
indicate that hexazinone is mobile in soil and that the degree
of mobility is dependent on soil type. Further, hexazinone is
persistent in soils. Because no complete and acceptable data
base is available to fully assess the ground-water contamination
potential of hexazinone/ the Agency will await submission of the
required photodegradation, metabolism, mobility, dissipation, and
groundwater monitoring studies before making a final assessment.
Fish accumulation studies showed that hexazinone does not
have the tendency to accumulate in fish. A confined rotational
crop study reviewed by the Agency was found not acceptable and
must be repeated. Hexazinone's ditchbank use triggers the require-
ment for an irrigated crop study.
The Agency is requiring Droplet Spectrum and Spray Drift
Field Evaluation tests because of the phytotoxicity of hexazinone,
its aerial method of application, and the potential exposure of
off-site plants to the pesticide.
ECOLOGICAL EFFECTS
Hexazinone is registered for numerous outdoor uses,
.including agricultural crops such as alfalfa and sugarcane,
and nonagricultural uses such as forests and aquatic ditchbanks.
Exposure to nontarget organisms can result from residues of
direct applications, spray drift from treated areas, and rnoff
from treated areas. Such exposures would be both acute and
chronic. Due to the absence of appropriate environmental fate
and nontarget organism toxicity data, a full ecological effects
hazard assessment cannot be completed at this time.
Aquatic Organisms - The available information indicates
that hexazinone is practically non-toxic to fish. The Guideline
requirements for freshwater fish acute LC$Q data with technical
hexazinone have been met. The LC5Q for freshwater fish results
from two 96-hour studies using the technical grade material
and the LC values are:
Species
Rainbow trout
Bluefill sunfish
Fathead minnow
Bluegill sunfish
% active
mg/1
97
97
97
95.0
>320
>370
= 274
=505
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Hexazinone is practically non-toxic to freshwater aquatic
invertebrates (daphnids) with an EC5Q value equal to 145.3 mg/1.
With respect to toxicity to estuarine invertebrates, technical
hexazinone is practically non-toxic to molluscs (48-hour EC5g
>320 mg/1) and slightly toxic to crustaceans (96-hour LC50 =
78 mg/1 for shrimp, 96-hour LC50 >1000 mg/1 for fiddler crabs).
Terrestrial Organisms - The Guideline requirements for acute
avian toxicity have been fulfilled. These data indicate that
technical hexazinone is practically non-toxic on an acute oral
basis to bobwhite quail (LD50 = 2258 mg/kg). Hexazinone was
also considered practically non-toxic in two avian dietary
toxicity studies (mallard LC5Q >10,000 ppm and in bobwhite
quail LC5Q >500° PP™)-
There is insufficient information to assess hexazinone's
toxicity to honeybees. As hexazinone has numerous outdoor uses
which may result in bee exposure, data from a bee acute contact
study are required.
Species Risk Assessment - Agricultural uses have application
rates typically up to 1.5 Ib ai/A and noncrop uses up to 12 Ib
ai/A. Maximum expected residues on avian foodstuffs at the
highest label rates would not be expected to exceed 3000 ppm.
The maximum residue in 6 inches of water resulting from a direct
application at the maximum rate would be 8.8 ppm. With avian
LC50S greater than 5000 ppm and aquatic organism LCsgs greater than
100 ppm, hexazinone is not expected to pose an acute risk to nontarget
fauna. Granular or pelleted products are not expected to pose an
acute risk to avifauna as the acute oral LD5g is greater than 2000
mg/kg. The chronic hazard associated with these exposures cannot
be determined.
Endangered Species - Because of hexazinone's expected toxicity
to nontarget plant species (based on its label claims as a herbicide)
and its intended use pattern, hexazinone has been identified by
the Office of Endangered Species, U.S. Fish and Wildlife Service
(FWS), as being likely to jeopardize endangered plant species
when used on forests and/or rangeland. EPA is working with the
FWS and other Federal and State agencies to implement labeling to
protect endangered plant species. When that program is fully
developed, notice of any labeling necessary to protect endangered
species will be issued.
Plant Protection - To determine the toxicity of hexazinone
to non-target plants, the Agency is requiring seed germination/
seedling emergence and vegetative vigor testing. As stated in the
Environmental Fate Section, because hexazinone is also registered
for aerial application, spray drift and droplet size studies are
required.
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PRODUCT CHEMISTRY
Although product chemistry data has been submitted in
the past, the Agency has determined that these data must be
resubmitted for each p.esticide. New requirements have been
introduced and previously submitted data must be updated.
The Agency has also identifed that hexazinone could have
nitrosamine contaminants due to the presence of certain
chemicals in the manufacturing process. Therefore the Agency
is requiring a discussion regarding the possible presence
of nitrosamines from any manufacturing component or manufacturing
process of hexazinone as well as chemical analysis of technical
hexazinone for nitrosamine.
C. TOLERANCE ASSESSMENT
Tolerances have been established for residues of hexazinone
in or on the raw agricultural commodities listed in 40 CFR
180.396. Tolerances for hexazinone are presently expressed in
terms of the combined residues of hexazinone and its metabolites
(calculated as hexazinone).
The existing residue chemistry data base was reviewed in the
initial Hexazinone Registration Standard (February 1982) and found
to be sufficient to assess the tolerances established at that time;
no outstanding data gaps were identified. Subsequently, new uses
of hexazinone have been registered and new Pesticide Assessment
Guidelines (Subdivision 0) have been issued. As a result, some
of the conclusions made in the February 1982 Standard concerning
the adequacy of data and conclusions about hexazinone have been
reversed or altered. The following is the Agency's current
position.
Metabolism - The nature of the residue in plants is
adequately understood. However, the metabolism of hexazinone in
animals is not adequately understood. Metabolism studies charac-
terizing the total terminal residue of hexazinone in ruminants
and poultry are required.
Analytical methodology - The 1982 Standard concluded that
the GLC/nitrogen detector method was adequate for measuring
hexazinone residues. This method has undergone successful FDA
method validation. Residues of hexazinone and its metabolites
occurring in or on raw agricultural commodities must be subjected
to analysis by PAM Vol. I methods 211.I/ 212.1/252, 232.2, 232.4,
and 242.2. These data are required because in some commodities
the sum of the limits of the detection of hexazinone and its
metabolites exceed the established tolerance for the combined
residues of hexazinone and/or analysis of the metabolites is
incomplete.
Residue data generated using the GLC/nitrogen detector
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method currently on file with the Agency will be reassessed on
receipt' of the aforementioned required data. Also, methods to
be used in the future for data collection and enforcement will be
determine^ on receipt of the requested metabolism and analytical
method validation data.
Residue Storage Stability - The Agency does not have any data
pertaining to the storage stability of hexazinone in commodities.
When submitting this information to the Agency, storage conditions
and intervals data must be supplied. This information must be
accompanied by data depicting the percent decline in residues of
hexazinone and its metabolites under the storage conditions and
for the intervals specified. Samples bearing field-weathered
residues or fortified samples of one representative commodity
from each group must be analyzed immediately after harvest or
fortification and again after storage intervals that are equivalent
to those reflected in all previously submitted and currently
requested residue data.
As stated earlier, the nature of the residue in animals is
not adequately understood. If the requested animal metabolism
data indicate the presence of additional metabolites of toxicological
concern, data depicting the stability of those residues in storage
will be required.
Magnitude of Residues - The adequacy of established tolerances
for hexazinone are based upon the Agency's evaluation of the existing
data base. The Agency notes that the combined limits of detection
for all metabolites of concern for several commodities (blueberries,
sugarcane, and pineapple) exceed the established tolerances.
Additional residue data are required to support the established
tolerances for residues in or on blueberries, pineapples, and
sugarcane.
There are no direct animal treatments for the herbicide
hexazinone. At the present time, it is not possible to calculate
the maximum expected intake of hexazinone residues by dairy
cattle, beef cattle, poultry, or swine. Upon receipt of the
storage stability and metabolism data, the nature of tolerances
for hexazinone residues will be assessed and theoretical dietary
exposures calculated.
Processing Data - Processing studies depicting the concen-
tration of hexazinone residues in pineapple bran and juice and
for sugarcane in molasses, bagasse, and refined sugar are
required.
Pre-harvest Intervals - Pre-harvest intervals (PHI) that are
based upon actual field residue data reflecting the maximum proposed
use rates are needed for applications of hexazinone to alfalfa
hay, pineapples, blueberries, and sugarcane.
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Other Findings - The commodity entry "pineapple fodder"
is inappropriate and should be deleted from the 40 CFR 180.396.
A tolerance must be proposed for pasture hay. Once this
tolerance is established, it will allow the removal of the imprac-
tical restriction on labels against the cutting of hay.
All pertinent.product labels must remove the impractical
restriction on the feeding of alfalfa hay from the label. This
is because the feeding of alfalfa hay is not under grower control.
Presently, no Codex MRLs exist for residues of hexazinone
in or on any plant or animal commodity, therefore no compatibility
problems exist between U.S. tolerances and Codex MRLs.
Dietary Assessment - The United States Department of Agriculture
does not monitor residue data on hexazinone as part of the National
Residue Program. The domestic and import samples collected by
the FDA in FY 78-88 to date, and the Total Diet Market Baskets
collected in April 1982 through April 1986 were not analyzed by
methodology known to be capable of determining residues of hexazinone.
For the U.S. population, the theoretical maximum residue
contribution (TMRC) from established tolerances was calculated to
be 0.001587 mg/kg/day for a 60 kg person based on a 1.5 kg diet.
This TMRC corresponds to 4.8% of the provisional acceptable daily
intake (PADI). Utilizing the chronic toxicity study in rats, the
PADI was established at 0.033 mg/kg/day, based on the NOEL of 10
mg/kg and a 300-fold safety factor. This is a PADI calculation
because the chronic data base for hexazinone is not complete.
The ADI will be calculated when the required data are received
and evaluated.
IV. REGULATORY ASSESSMENT
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data on
hexazinone, the Agency has made the following determinations:
1. The Agency will not place hexazinone in Special Review
at this time.
Rationale: Based on the data available to the Agency,
hexazinone has not met or exceeded any of the risk criteria speci-
fied in 40 CFR 154.7 for Special Review. There are presently no
chronic toxicological concerns for exposure to hexazinone and
there are sufficient data to indicate no unreasonable hazard to
wildlife or endangered animal species. However, the Agency will
delay a final determination until the chronic mouse study slides
are reexamined. The Agency will evaluate potential risks as
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additional data become available and will consider additional
regulatory action, if applicable.
2. The Agency is not classifying any hexazinone products or
uses as Restricted Use.
Rationale: Based on data available to the Agency,
hexazinone products have not met or exceeded any of the criteria
specified in 40 CFR 162.11 which would indicate a need to
restrict its use. When data become available to quantify the
risks of hexazinone the Agency will reconsider its position on
the classification of hexazinone.
3. The Agency will not register any significant new uses
of hexazinone until product chemistry, toxicology, environmental
fate, ecological effects and residue chemistry data required by
this Standard have been submitted and found to be acceptable for
assessing the proposed uses and demonstrate that the proposed
uses will not result in unreasonable risks.
Rationale: The data gaps in these areas are such that
registration of significant new uses of hexazinone should await
submission and evaluation of the critical data required by this
Standard.
4. The Agency is requiring ground water monitoring studies
on hexazinone and its degradates to determine whether it contam-
inates ground water.
Rationale: Hexazinone and its degradates have been
shown to be mobile in certain soils and persistent in water.
Further, hexazinone is structurally related to other pesticides that
do leach. The Agency does not feel that regulatory action, other
than requiring retrospective ground water monitoring-studies, is
warranted.
5. The Agency will immediately review certain data as they
are submitted.
Rationale: Because of concerns regarding potential
risks from hexazinone use, the Agency believes it is essential
that the following data be reviewed as they are received: the
slides from the mouse oncogenicity study, the additional data on
the reproduction study, and the acute oral study.
6. The Agency is requiring that a tolerance for pasture/
rangeland hay be proposed so that the restriction against
the cutting of hay from pasture/rangeland grass treated with
hexazinone be removed from the label.
Rationale; Since a label restriction forbidding the
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cutting of hay from treated grasses is impractical, then a
tolerance for such use must be established.
7. The Agency is requiring that the tolerance for alfalfa
hay be revised in order to remove the label restriction against
the feeding of alfalfa hay treated with hexazinon-e.
Rationale; A label restriction forbidding the feeding
of alfalfa hay is impractical because such feeding is not under
grower control. Therefore, the Agency is requiring that a
revised tolerance for alfalfa hay be established and that an
appropriate shorter PHI for hay be proposed.
8. The Agency is requiring that there be restrictions on
the label forbidding the feeding of sugarcane forage to livestock
and the grazing of domestic animals on conifer release and forest
plantings areas.
Rationale: These restrictions must be on pertinent
labels until appropriate tolerances are established.
9. In order to meet the statutory standard for continued
registration, the Agency is requiring the use of certain minimum
protective equipment for end-use products. The required labeling
language is found in Section IV.D. of this document.
Rationale: Based on the primary eye irritation study,
the Agency finds that this requirement is necessary to protect
mixers, loaders, and applicators. The wearing of protective
goggles, face shield, or safety glasses as specified in the
required labeling will reduce exposure to hexazinone products and
decrease the risk of adverse effects.
10. The Agency is not requiring a reentry interval at this
time. However, the Agency reserves the right to call in reentry
data if and when the required toxicology studies demonstrate a
potential for chronic effects. The Agency believes that delaying
entry into treated areas until sprays have dried, as specified on
the label (see section IV. D.) will be sufficient.
Rationale: Reentry data are required under 40 CFR
158.140 only when both the toxicity and exposure criteria are
met. Hexazinone does meet the exposure criteria of 40 CFR 158.140
in that it is registered for use on blueberries, pineapple, and
Christmas trees (cultivation of these crops require extensive
hand labor). However, hexazinone is not applied either to the
foliage or concurrently when hand labor is required. The Agency
has not received adequate toxicological or epidemiological evidence
that residues of this pesticide can cause adverse effects on
persons entering treated sites.
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11. The Agency is requiring submission of droplet spectrum
and spray drift field evaluation tests.
Rationale: The Agency, is requiring these tests because
of the phytotoxicity of hexazinone, its methods of application
(aerial), and the likely exposure of off-site plants to the
pesticide.
12. The Agency has determined that "pineapple fodder"
must be deleted from the tolerance listing for hexazinone
in 40 CFR 180.396.
Rationale: The commodity "pineapple fodder" is
inappropriate because it is not a raw agricultural commodity.
13. The Office of Endangered Species (OES) in the U.S. Fish
and Wildlife Service has determined that certain uses of hexazinone
may jeopardize the continued existence of endangered plant species
or critical habitat of certain endangered animal species. EPA
is developing a program to reduce or eliminate exposure to these
species to a point where use does not result in jeopardy, and
will issue notice of any necessary labeling revisions when the
program is developed.
No additional labeling is being required at this time. As
explained below, labeling requirements issued in Pesticide Regu-
lation (PR) Notices 87-4 and 87-5 have been withdrawn pending
reissuance.
Rationale: In May 1987, EPA issued PR Notices 87-4 and
87-5 in response to OES findings that certain pesticides, includ-
ing this chemical, jeopardized the continued existence of endang-
ered 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.
14. While the data gaps are being filled, currently
registered MPs and EPs containing hexazinone as an active
ingredient may be sold, distributed, formulated, and used,
subject to the terms and conditions described in this Standard.
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Registrants must provide or agree to develop additional data, as
specified in the Data Appendices of this document, in order to
maintain existing registrations.
Rationale: Under FIFRA, the Agency may choose not to
cancel or withhold pesticide registrations if data are missing -or
inadequate (see FIFRA sections 3(c)(2)(B) and 3(c)(7)).
Issuance of this Registration Standard provides a mechanism
for identifying data needs. When these data are submitted they
will be reviewed and evaluated, after which the Agency will
determine if additional regulatory action is warranted.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, manufacturing
use and end use products must contain this Pesticide, bear required
labeling, and conform to the product composition, acute toxicity
limits, and use pattern requirements listed in this document.
C. ACCEPTABLE RANGES AND LIMITS
Product Composition Standard. To conform to this Standard,
manufacturing use end use products must contain this pesticide
ingredient. Each formulation proposed for registration must be
fully described with an appropriate certification of limits,
stating maximum and minimum amounts of the active and intentionally
added inert ingredients present in the product, as well as impurities
found at levels greater than 0.1 percent.
Acute Toxicity Limits. The Agency will consider registration of
technical grade and manufacturing-use products containing this
pesticide ingredient, provided the product is supported by
appropriate acute toxicity data and the labeling for the product
bears appropriate precautionary statements for the toxicity
category in which the product is placed.
Use Patterns. To be registered under this Standard, manufacturing
use products must be labeled for formulation into other manufacturing
use products or into end use products bearing federally registered
uses. The EPA Use Index (EPA Compendium of Acceptable Uses) (for
availability, see page 1) lists all federally registered uses of
this pesticide ingredient, as well as approved maximum application
rates and frequencies.
The use patterns currently registered are terrestrial food and
nonfood crop; aquatic nonfood crop; and forestry.
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D. LABELING
In order to remain in compliance with FIFRA, all 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 further information on label requirements.
Pesticide products containing this pesticide as an active ingredient
may not be released for shipment by the registrant after September
1989 unless the product bears amended labeling that complies with
the requirements of FIFRA, as set out in this Registration Standard.
Pesticide products containing this pesticide as an active ingredient
may not be distributed or sold after September 1990 unless the
product bears amended labeling that complies with the requirements
of this Standard.
In order to remain in compliance with FIFRA, the following information
must appear on the labeling of all manufacturing-use (MPs) and
end-use products (EPs).
1. Ingredient Statement. The ingredient statement for MPs and EPs
must list the active ingredient as:
ACTIVE INGREDIENT
Hexazinone (3-cyclohexyl-6-(dimethylamino)-l-methyl-l,3,5-
triazine-2,4-(!H,3H)-dione) %
2. Use Pattern Statements. All technical and manufacturing-use
products must state that they are intended for formulation into
end-use products registered for one or more of the uses listed in
the EPA compendium of acceptable uses. 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,
as provided in this Registration Standard.
3. The Following Must Appear on HP Labels
"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 EPA."
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4. The Following Must Appear on EP Labels
In the Precautionary Statements
"Corrosive, causes irreversible eye damage. Harmful
if swallowed. Do not get in eyes or on clothing. Mixers,
loaders, and applicators must wear goggles, face shield, or
safety glasses. Wash thoroughly with soap and water after
handling. Remove contaminated clothing and wash before
reuse."
Environmental Hazards Statement
"Do not apply directly to water or wetlands (swamps, bogs,
marshes, and potholes). Do not contaminate water when
disposing of equipment washwaters."
In the Directions for Use Section
"Do not enter or allow entry into treated areas until
sprays have dried to perform hand tasks. A person may enter
the areas to perform other tasks only if the person is
wearing the personal protective eye equipment listed on the
label."
As appropriate, the following grazing statements should
appear in the label:
For sugarcane: "Do not feed sugarcane forage to livestock."
For conifer release and forest plantings (reforestation
site preparation): "Do not graze domestic animals on
treated areas within 30 days after treatment."
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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 B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial statement of Formula, data compensation provisions)
associated with reregistration.
2 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 Registra-
tion 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.
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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.
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 exemption^, 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 require-
ments 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.
3 If 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 th« 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.
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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.
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 regis-
tration of products containing this active ingredient.*
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 S 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
4 Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed
in this Registration Standard.
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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.
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 "PIPRA 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:
t,
1. 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
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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 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 con-
sortium 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:
1. 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).
27
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2. 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:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(3) 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 OCX, 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 foe 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 foj: a waiver.
5. You request that EPA amend your registration bv 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.
28
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6. You request voluntary cancellation of the registration
of vour product(s) for which the data are needed.
E. Reqiscrant 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.
P. 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
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.
29
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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.
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.
30
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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 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. A3 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 ace 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.
31
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a. Generic Data Exemption Statement (EPA Form 8580-3),
if-applicable, o_r 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.
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 foe 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
33
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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 Registra-
tion 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, D.C. 20460
Attn: Hexazinone Registration Standard
All submittals in response to this Registration Standard
are non-fee items, including 90-day responses, protocols and
waiver requests, data, and revised labeling. Submittals must
be clearly identified as being in response to the Registration
Standard. Under no circumstances may Registration Standard
responses be combined with other types of filings for which
fees are required.
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:
32
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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:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, ojr 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 PIFRA 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.
34
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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.
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.
35
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I. DATA APPENDICES
36
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TGUIDE-1
GUIDE TO TABLES
Tables A, 3, 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 Port 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
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table.
37
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TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data comoensation 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 infor-
mation.
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.
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 3
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 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are generally 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.
38
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Table A
Generic Data Requirements for the Technical Grade of the Active Ingredient: HexazinoneV
Data Requirement
Test
Substance
Does EPA
Have Data to
Satisfy This
Requirement?
Timeframe
Bibliographic Must Additional for
Citation Data Be Submitted?2/ Submission
Part 158 - Subpart C - Product Chemistry
Product Identity and Composition
61-2 - Description of Beginning TGAI
Materials and Manufac-
turing Process
61-3 - Discussion of Formation
of Impurities
TGAI
No
No
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis
of Product Samples
TGAI
NO
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density,
or Specific Gravity
YesV
YesV
YesV
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Yes
Yes
Yes
No
Nq8/
Yes
00104969
00104969
00104969
00104969
No
No
No
Yes6
No
No
,77
6 Months
6 Mont Iu3
12 Months
6 Months
63-8 - Solubility
TGAI or PAI
Yes
00104969
No
-------
Table A
Generic Data Requirements for the Technical Grade of the Active Ingredient;: HexazinoneV
Part
Data
158 -
Requirement
Subpart C - Product
Test
Substance
Chemistry
Does EPA
Have Data to
Satisfy This
Requirement?
(continued)
Bibliographic
Citation
Must
Data
Adi
be
Utional
submitted?2/
Time frame
for
Submission
Physical and Chemical Characteristics (Cont'd)
63-9 - Vapor Pressure TGAI or PAI Yes
63-10 - Dissociation Constant TGAI or PAI No
63-11 - Octanol/Water Partition PAI No
Coefficient
63-12 - pH TGAI Partially
63-13 - Stability TGAI No
Other Requirements:
64-1 - Submittal of Samples N/A N/A
00104969
No
Yes6
00118509
Yes/
No
6 Months
6 Months
6 Months
6 Months
I/The 98% T (EPA Registration No. 352-399) also serves as a manufacturing-use product. See also Table B,
"Product Specific Data RequLcements for Manufacturing-Use Pro.lioi-.s," for additional data requicements under
Guidelines Reference Nos. 61-1, 62-2, 62-3, and 63-14 through 63-20 that are applicable to registered technical
products.
2/Although product chemistry data may have been submitted in the past, the Agency has determined that certain of
these data must be resubmitted. New requirecants have been Introduced and previous submitted data must be updated.
Therefore, many bibliographic citations for the old data are not applicable. However, data submitted in response
to requests made In 'die interim Standard, dated ?ebnuir:y 1.037, have been evaluated with cegard to theic adequacy in
meeting the requirements of 40 CFR 158 Subpart C.
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 }<1V<1, i.'ne chemical equations for each Intended
reaction, equipment used to produce each intermediate and the final product, re^oi-lon conditions, the duration
-------
Table A
Generic Data Requirements for the Technical Grade of the Active Ingredient: HexazinoneJ/ (Cont'd)
Part 158 - Subpart C - Product Chemistry Footnotes (Cont'd)
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 used in the manufacture of each
product must be provided, along with information regarding the properties of those materials.
4/A detailed discussion must be submitted for the 98% T 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 that may occur during and after production. A discussion regarding the possible
presence of nitrosamines or any other contaminant of toxicologic concern from any source in the product is also
required.
5/Samples from five or more representative batches must be analyzed for the amount of active ingredient and each
impurity for which certified limits are required. Complete validation data (accuracy and precision) must be
submitted for each analytical method used. All nitrosamines must be identified and quantified (by methods
sensitive to 1 ppm of N-nitroso contaminants) in six product samples; two samples of each must be analyzed
shortly after production, 3 months after production, and 6 months after production. Upper limits must be
provided and certified for all nitrosamines found.
6/Physicochemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
solubility, vapor pressure, dissociation constant, partition coefficient, pH, and stability) as required in
40 CFR 158 Subpart C and more fully described in the Pesticide Assessment Guidelines, Subdivision D, must
be submitted.
7/The technical chemical is a solid at room temperature; therefore, data are required.
8/Data are not required because the technical product is a solid at room temperature.
9/Data required if the technical product is organic and nonpolar.
10/Data required if the test substance is soluble or dispersible in water.
-------
Table A
Generic Data Requiren-;:ii.:i for Hexazinone
Data Requirement
Does EPA Have
Test Data to Satisfy Bibliographic
Substance This Requirement? Citation
Must Additional
Data Be Submitted?
Timeframe
for
Submission
S158.240 Residue Chemistry
171-2 - Chemical Identity^/
171-3 - Directions for Use
171-4 - Nature of the Residue
(Metabolism)
- Plants
171-4 - Nature of the Residue
(Metabolism)
- Livestock
171-4 - Residue Analytical
Methods
171-4 - Storage Stability
171-4 - Magnitude of the
Residue in Plants
o Small Fruits and
Reccies
(See Index)
PAIRA
PAIRA and Partially
plant
metabolites
TGAI and Partially
metabolites
TEP and
metabolites
No
00073047,00104846,
00126127
No
00104843
000 W868,00101574,
00126127
Yes2/3/
Yes5/
18 Months
15 Months
15 Months
- Blueberries
TEP
Partiallv 00101574
Yes6/
18 Months
-------
Table A
Generic Data Requirements for Hexazinone
Data Requirement
Does EPA Have
Test Data to Satisfy Bibliographic
Substance This Requirement? Citation
Must Additional
Data Be Submitted?
Timeframe
for
Submission
S158.240 Residue Chemistry
171-4 - Magnitude of the
Residue in Plants (Cont'd)
o Grass Forage,
Fodder and Hay
- Grasses, TEP
Pastureland/
Rangeland
o Nongrass Animal
Feeds
- Alfalfa Forage/ TEP
Hay
o Miscellaneous
Commodities
171-4 - Magnitude of
the Residue in
MiIk/Meat/Poult ry/Eggs
- Milk, Fat, Meat
Byproducts, and
Meat of Cattle,
Goats, Hogs,
Horses, and Sheep
Partially 00138226
Partially 00118050
- Pineapple
- Sugarcane
TEP
TEP
Partially
Partially
00126127
00028733
00114039
TGAI or
plant
metabolites
Partially 00028866
Yes7/
Yes8/
Yes9,10/
Yes'17/
Yes"/
6 Months
6 Months
18 Months
24 Months
18 Months
24 Months
18 Months
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Table A
Generic Data Requirements for Hexazinone
Does EPA Have Timeframe
Test Data To Satisfy Bibliographic Must Additional for
Data Requirement Substance This Requirement? Citation Data Be Submitted? Submission
S158.240 Residue Chemistry
171-4 - Magnitude of
the Residue in
Milk/Meat/Poultry/Eggs (Cont'd)
- Eggs, Fat, Meat TGAI or Partially 00104845 YesH/ 18 Months
Byproducts, and plant
Meat of Poultry metabolites
I/The same chemical identity data are required under §158 - Subpart C, with emphasis on impurities that could
constitute residue problems. Refer to Product Chemistry Data Requirements tables.
2/Metabolism studies must be submitted characterizing the total terminal residue of hexazinone in ruminants and
poultry. Animals must be dosed orally for a minimum of 3 days with ring-labeled [14C]hexazinone fed in the diet
at a level sufficient to make residue identification and quantification possible. Milk and eggs must be collected
for analysis twice daily during the dosing period. Animals must be slaughtered within 24 hours of the final
dose. The distribution and identity of residues must be determined in milk, eggs, liver, kidney, muscle, and
fat. Samples from these studies must also be analyzed using residue analytical methods developed for data
[ collection and tolerance enforcement to ascertain that the methods are capable of adequately recovering and
identifying all residues of concern.
3/Data depicting the nature of hexazinone residues in swine will also be required if the required metabolism
studies with ruminants and poultry reveal that the metabolism of hexazinone in these animals differs from that
in rats.
4/Residues of hezaxinone and its metabolites occurring in or on raw agricultural commodities must be subjected to
analysis by PAM Vol. I methods 211./212.1/252, 232.4, and 242.2 (Multiresidue Protocols I-IV, available from the
National Technical Information Service (NTIS) under Order No. PB 203734/AS).
5/Storage conditions and intervals must be submitted for all samples used to provide data reviewed or requested.
This information must be accompanied by data depicting the percent decline in residues of hexazinone
-------
Table A
Generic Data Requirements for Hexazinone
S158.240 Residue Chemistry Footnotes (Cont'd)
and its metabolites under the storage conditions and for the intervals specified. Samples bearing field-weathered
residues or fortified samples of one representative commodity from each crop group must be analyzed immediately
after harvest or fortification and again after storage intervals that are equivalent to those reflected in all
previously submitted and currently requested residue data. The storage intervals selected must allow for reasonable
unforeseen delays in sample analysis. For additional guidance on conducting storage stability studies, the
Registrant is referred to an August 1987 Position Document on the Effects of Storage on Validity of Pesticide
Residue Data available from NTIS under Order No. PB88112362/AS.
6/Data must be submitted depicting combined residues of hexazinone and its metabolites (calculated as hexazinone)
in or on mature blueberries harvested following broadcast application of (in separate tests) the 90% SC/L and 2
Ib/gal EC formulations at 3 Ib ai/A, applied with aerial and ground equipment, in separate tests, in a minimum
of 5 and 40 gal/A, respectively. The registrant must propose amendments to all pertinent product labels that
specify an appropriate PHI (based on the requested data). Tests must be conducted in ME and NH in which these
uses are permitted (EPA SLN Nos. ME830003, ME830002, NH830007, and NH830008).
7/The registrant must amend all pertinent product labels to remove the impractical restriction against the cutting
of grass hay. The registrant must also propose a tolerance for pasture hay supported by appropriate residue data.
8/The registrant must amend all pertinent product labels removing the impractical restriction on the feeding of
hay because alfalfa hay may not be under grower control for 30 days. In addition, the registrant should propose
an appropriate shorter PHI for hay which must be supported by appropriate residue data.
9/Data must be submitted depicting the combined residues of hexazinone and its metabolites (calculated as hexazinone)
in or on pineapples harvested at normal crop maturity following the last of three postemergence directed spray
applications of the 90% SC/L formulation at 1.8 Ib ai/A/application, in 50 gal of water/A using aerial equipment.
The registrant must amend all pertinent labels specifying a PHI which must be efficacious and supported by residue
data. Tests must be conducted in HI which accounted for virtually all of the 1982 U.S. pineapple production
(1982 Census of Agriculture, Vol. 1, Part 51, p. 383).
10/Data must be submitted depicting the combined residues of hexazinone and its metabolites (calculated as hexazinone)
in or on pineapples harvested at normal crop maturity following multiple spot treatment applications of the 90%
SC/L formulation at 1.8 Ib ai/100 gal.
11/A processing study must be submitted depicting concentration of the combined residues of hexazinone and its
metabolites (calculated as hexazinone) in bran and juice processed from pineapples bearing measurable, weathered
residues. If residues concentrate in any product^ appropriate food/feed additive tolerance must be proposed.
12/Data must be submitted depicting the combined residues of hexazinone and its metabolites (calculated as hexazinone)
in or on sugarcane harvested at normal crop maturity following: (i) a single postemergence broadcast application
of the 90% SC/L formulation at 3.6 Ib ai/A, in 25 gal water/A using ground equipment, and in 5 gal/A using
-------
Table A
Generic Data Requirements for Hexazinone
S158.240 Residue Chemistry Footnotes (Cont'd)
aerial equipment, followed by multiple spot treatments at 1.8 Ibs ai/100 gal water (tests must be conducted in
HI); (ii) a single postemergence application of the 90% SC/L formulation at 1.8 Ib ai/A, in 25 gal water/A using
ground equipment (tests must be conducted in FL); and (iii) a single layby application at 0.9 Ib ai/A, in 5 gal
water/A using aerial equipment (tests must be conducted in TX). The registrant must propose label amendments
specifying a PHI which must be efficacious and supported by appropriate residue data.
13/A processing study must be submitted depicting concentration of the combined residues of hexazinone and its
metabolites (calculated as hexazinone) in molasses, bagasse, and refined sugar processed from sugarcane bearing
measurable, weathered residues. If residues concentrate in any product, appropriate food/feed additive tolerances
must be proposed.
14/Data requirements regarding the magnitude of hexazinone residues in animal products will not be determined until
all requested data regarding metabolism in animals and magnitude of residues in feed items have been received.
ON
-------
Table A
Generic Data Requirements for Hexazinone
Data Requirement
Test
Substance
Does EPA
Have Data Must Additional Timeframe
Use To Fill This Bibliographic Data be for
Pattern Requirement? Citation Submitted? Submission
§158.490 Wildlife and Aquatic Organisms
Avian and Mammalian Testing
71-1 -
71-2 -
71-3 -
71-4 -
71-5 -
Aquatic
72-1 -
Aquatic
72-2 -
Avian Oral LDso
Avian Dietary LC5Q
a. Waterfowl
b. Upland Game Bird
Wild Mammal Toxicity
Avian reproduction
Simulated and Actual
Field Testing - Mammals
and Birds
Organisms Testing
Freshwater Fish LC5Q
a. Warmwater
b. Coldwater
Organisms Testing
Freshwater Invertebrate
Acute EC5Q
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TGAI
TEP
TGAI
TEP
A,B,D,G
A,B,D,G
A,B,D,G
A,B,D,G
A,B,D,G
A,B,D,G
A,B,D,G
D,G
A;B,D,G
D,G
A,B,D,G
D,G
Yes 00078016
Yes 00078029
Yes 00078002
No
No
No
Yes 00078044,00078040
No
Yes 00078044
No
Yes 00078042
No
No
No
No
Noj/
Yes2/
NoV
No
Yes4/
No
Yes!/
No
Yes_4/
2 Years
9 Months
9 Months
9 Months
-------
Table A
Generic Data Requirements for Hexazinone
oo
Data Requirement
S158.490 Wildlife and Aquatic
Test
Substance
Organisms
Aquatic Orqanisms Testing (Cont'd)
72-3 - Estuarine and Marine
Organism Acute EC5Q
a. Finfish TGAI
b. Crustacean TGAI
c. Oyster TGAI
Use
Pattern
A,B,D,G
A,B,D,G
A,B,D,G
Does EPA
Have Data To
Satisfy this
Data Requirement?
No
Yes
Yes
Bibliographic Must Additional
Citation Data be Submitted?
No5/
00078018 No
00078018 No
Time frame
for
Submission
72-4 - Fish and Early Life Stage TGAI
and Aquatic Invertebrate
Life Cycle
72-5 - Aquatic Organism TGAI
Accumulation
72-6 - Life-Cycle Tests with TGAI
Fish
72-7 - Simulated or Actual TEP
Field Testing - Aquatic
§158.540 Plant Protection
TIER I
122-1 - Seed Germination/ TGAI
Seedling Emergence
122-1 - Vegetative Vigor TGAI
122-2 - Aquatic Plant Growth TGAI
A,B,D,G
D,G
D,G
A,B,D,G
No
Yes
No
No
00064265
Yes6/
No
No7/
No7/
1 Year
B,D,G
B,D,G
B,D,G
No
No
No
No8/
No8/
NqB/
-------
Table A
Generic Data Requirements for Hexazinone
Does EPA Have Timeframe
Test Use Data To Satisfy Bibliographic Must Additional for
Substance Pattern This Requirement? Citation Data)Be)Submitted? Submission
Data Requirement
§158.540 Plant Protection (Cont'd)
TIER II
123-1 - Seed Germination/
123-1
123-2
124-1
124-2
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
TIER III
- Terrestrial Field
- Aquatic Field
TGAI
TGAI
TGAI
TGAI
TGAI
B,D,G
B,D,G
B,D,G
B,D,G
B,D,G
NO
NO
NO
NO
NO
YesV
Yes^/'
Yes£/
Yes10/
YesW
9 Months
9 Months
9 Months
I/Not generally required. Hexazinone does not trigger the special conditions necessary to require this study.
2/Avian reproduction testing is required to ascertain the chronic hazard of hexazinone residues expected to persist
on avian foodstuffs.
3/Reserved pending receipt of avian reproduction and environmental fate requirements.
4/Required for formulated products (emulsifiable concentrates and solvent-based liquid formulations) used in forests
and/or aquatic nonfood uses.
5_/Waived based on demonstrated low toxicity to freshwater fish. TEP testing is reserved pending receipt of requested
TEP testing on freshwater fish.
^/Required due to expected transport to and persistence in aquatic environments.
7/Reserved pending recept of outstanding aquatic data and environmental fate information.
8/These tests are not required since hexazinone is registered for use as a herbicide.
VRequired for all terrestrial nonfood, aquatic food and forest uses.
10/Hiqher tier testing is reserved pending receipt of the lower tier test results.
-------
Table A
Generic Data Requirements for Hexazinone
Data Requirement
Test Use
Substance Pattern
Does EPA Have Timeframe
Data to Satisfy Bibliographic Must Additonal Data for
This Requirement? Citation Be Submitted? Submission
en
CD
S158.290 Environmental Fate
Degradation Studies - Lab
161-1 - Hydrolysis PAIRA A,B,D,G
Photodeqradation
161-2 - In Water PAIRA A,B,D,G
161-3 - On Soil PAIRA A
161-4 - In Air
Metabolism Studies - Lab
162-1 - Aerobic Soil PAIRA A,B,G
162-2 - Anaerobic Soil PAIRA A
162-3 - Anaerobic Aquatic PAIRA D,G
163-4 - Aerobic Aquatic PAIRA D
Mobility Studies
163-1 - Adsorption/Desorption PAIRA A,8,0,0
Yes
00064260
Partially 00064260
Partially 00064261
Partially 00064261
Partially 00064261
No
No
Partially 00064262
NV
Yes6/
Yes]/
Yes]/
Yes8/
9 Months
9 Months
27 Months
27 Months
27 Months
27 Months
12 Months
-------
Table A
Generic Data Requirements for Hexazinone
Data Requirement
S158.290 Environmental Fate
Mobility Studies (Cont'd)
163-2 - Volatility (Lab)
164-3 - Volatility (Field)
Dissipation Studies - Field
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
Does EPA Have
Test Use Data to Satisfy Bibliographic
Substance Pattern This Requirement? Citation
TEP A,B Partially 00064261
TEP D No
TEP G Partially 00072664
Must Additional
Data Be Submitted?
No£/
NoV
Yes
Yesj^/
Time frame
for
Submission
27 Months
27 Months
27 Months
164-4 - Combination and
Tank Mixes
165-5 - Soil, Long-Term
Accumulation Studies
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
PAIRA
TEP
No
D
No
Reserved^V
Yes 39 Months
Reserved^/
39 Months
-------
Table A
Generic Data Requirements for Hexazinone
Data Requirement
Test Use
Substance Pattern
Does EPA Have
Data to Satisfy
This Requirement?
Bibliogtaphic
Citation
Must Additonal
Data Be Submitted?
Timeframe
for
Submission
§158.290 Environmental Fate
Accumulation Studies (Cont'd)
165-4 - In Fish PAIRA
165-5 - In Aquatic Nontarget
Organisms
§158.390 Reentry Protection
132-1 - Foliar Dissipation TEP
132-1 - Soil Dissipation TEP
133-3 - Dermal Exposure TEP
133-4 - Inhalation Exposure TEP
§158.440 Spray Drift
201-1 - Droplet Size Spectrum TEP
201-1 - Drift Field Evaluation TEP
§158.290 Environmental Fate
Ground Water Monitoring Studies
Human Exposure Assessment
A,B,D,G
Yes
No
A,B,G
NONE
A,B,G
A,B,G
No
NO
NO
No
A,B,D,G No
A,B,D,G No
00064265
No
Reserved^/
NoW
Reserved^/
Reserved^V
Yes19/
YesW
Yes
Reserved2O/
12 Months
12 Months
39 Months
24 Months
-------
Table A
Generic Data Requirements for Hexazinone
S158.290 Environmental Fate Footnotes
I/Although the hydrolysis studies are not fully in accordance with current Subdivision N Guidelines, the reported
results clearly indicate that hydrolysis is not an important degradation pathway for hexazinone and, therefore,
the study can be accepted to fulfill data requirements for hydrolysis.
2/The photodegradation study includes studies in distilled water, in "standard reference water," and with river
water with and without sediments. The studies were conducted under artificial sunlight (distilled water; standard
reference water) and under natural sunlight (river water). Although the photodegradation study in water was
considered acceptable to fulfill data requirements for the 1982 Registration Standard, it does not fulfill
present Subdivision N Guidelines. Therefore, the studies are considered to partially fill data requirements as
they indicate slow degradation in distilled water (about 20% in 8 weeks) at pH 6.1 (unbuffered) and that the
presence of photosensitizers resulted in an increased rate of photodegradation.
2/The photodegradation study on soil was conducted under artificial sunlight conditions. This study is not
acceptable under current Subdivision N Guidelines and, therefore, data requirements for photodegradation on
soils are only partially fulfilled.
4/Not required because the vapor pressure of hexazinone is below 10~6 mmHg.
5/This study was conducted under greenhouse conditions. This study was considered acceptable to fulfill data
requirements at the time the 1982 Registration Standard was prepared. However, under current Subdivision N
data requirements for aerobic metabolism the studies are not considered fulfilled as the study is not considered
acceptable under present Guidelines.
j>/This study was conducted by flooding the soil incubated under aerobic conditions (in a greenhouse). Because
r the aerobic incubation phase of this study does not meet current Subdivision N Guidelines, the anaerobic studies
are not acceptable and, therefore, do not fulfill data requirements. An acceptable anaerobic aquatic metabolism
study may be used to fulfill data requirements for anaerobic soil metabolism.
7/Both the aerobic and anaerobic metabolism studies are required to support registration for use on drainage ditch-
banks.
J3/A soil column leaching study (unaged and aged soil) and an adsorption/desorption study (soil TLC) are included in
this study. These studies do not fulfill current Subdivision N Guidelines. Although both studies indicate
that hexazinone is mobile, the radioactivity found in leachates was not characterized; aged soils leached less
than unaged soils; and soil TLC experiments were not adequately described. It is recommended that soil mobility
studies be conducted as batch equilibrium adsorption/desorption studies and that these studies include the main
degradation products of hexazinone.
-------
Table A
Generic Data Requirements for Hexazinone
S158.290 Environmental Fate Footnotes (Con't)
9/Not required because the vapor pressure of hexazinone at 25 °C is below 10~6 mmHg.
lg/The maximum application rate used was 4 Ib ai/A. The study does not support registration for terrestrial nonfood
uses, where the recommended application rates can be as high as 12 Ib ai/A (13.5 Ib ai/A to control Macartney
rose in TX). In addition, the studies do not properly define the depth of leaching (in the Keyport silt loam
soil, as high as 7.2% of the applied radioactivity was still detected in the 8- to 12-inch depth after 11
months). The submitted study was conducted in stainless steel cylinders using the radiolabeled material,
which is an acceptable procedure.
1I/The study used pellets placed by hand. Pellets contained 10% of active ingredient and were applied at a rate of
15 Ib of pellets per acre (1.5 Ib ai/A). The present highest recommended application rate is 6 Ib ai/A for
control of weeds (unspecified weeds, broadleaf weeds, and woody plants in conifer-release sites; limited to
areas east of the Rocky Mountains). Therefore, data are required to support registration at the highest
application rates.
12_/Tank mix data requirements are not being imposed by this standard.
13/This study is reserved pending the results of the soil dissipation studies under field conditions.
14/The need for this study is triggered by the results from the confined rotational crop study.
15/Required. Drainage ditchbanks constitute an aquatic use.
(-n 16/Not required because the fish accumulation studies (165-4) did not show any accumulation of hexazinone.
-^ 17/The Agency reserves judgment on the need for these data until adequate toxicology data have been received and
evaluated. The data necessary for this judgment are chronic adverse effects including neurotoxic, teratogenic,
reproductive, and oncogenic effects, for which the Agency requires toxicology testing in Subdivision F of the
Guidelines.
18/Soil dissipation data are required only for uses where workers will be exposed directly to substantial quantities
of soil during their work (for example, for use on potatoes or peanuts if hand harvesting will be performed).
19/The spray drift droplet spectrum and field evaluation may be done together in order to evaluate the droplet
spectrum that associated with actual field use patterns.
20/There is no need for a human exposure assessment until the Toxicology Branch resolves whether hexazinone is an
oncogen.
-------
Table A
Generic Data Requirements for Hexazinone
Data Requirement
Test Use
Substance Pattern
Does EPA Have Data
To Satisfy
This Requirement?
Bibliographic
Citation
Must Additional
Data be Submitted?
Timeframe
for
Submission
§158.590 Nontarqet Insect
Nontarqet Insect Testing - Pollinators
TGAI A,B,G
141-1 - Honey Bee Acute
Contact
141-2 - Honey Bee - Toxicity TEP
of Residues on
Foliage
A,B,G
(Jl
141-4 - Honey Bee Subacute
Feeding Study
141-5 - Field Testing for
Pollinators
[Reserved ]£/
TEP A,B,G
Nontarqet Insect Testing - Aquatic Insects
142-1 - Acute Toxicity to
Aquatic Insects
142-2 - Aquatic Insect Life
Cycle Study
142-3 - Simulated or Actual
Field Testing for
Aquatic Insects
143-1 - Nontarqet Insect
thru Testing - Predators
143-3 - and Parasites
[ Reserved ]£/
[Reserved]2/
[Reserved]2/
tReserved]3/
No
No
Yes
NoV
9 Months
No
No1/
-------
Table A
Generic Data Requirements for Hexazinone
S158.590 Nontarqet Insect Footnotes
I/Requirement deferred pending evaluation of data from the acute contact test.
2/Reserved pending development of test methodology.
3/Reserved pending Agency decision as to whether the data requirement should be established.
U1
ON
-------
Table A
Generic Data Requirements for Hexazinone
LH
Test
Data Requirement Substance
S158,
.135 Toxicoloqy
Use
Pattern
Does EPA
Have Data To
Satisfy Thts Bibliographic
Requirement? Citation
Time frame
Must Additional for
Data be Submitted? Submission
Acute Testinq
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral - Rat
- Acute Dermal - Rabbit
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation -
Rabbit
- Dermal Sensitization -
Guinea Pig
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
A
A
Partially 00104972
Partially 00104974
Partially 00104975
Yes 00106003
Yes 00106004
No
No
YesV
YesV
YesV
NO
No
Yes
No2/
9 Months
9 Months
Subchronic Testinq
82-1
82-2
82-3
- 90-Day Feeding
- Rodent
- Nonrodent
- 21-Day Dermal
- 90-Day Dermal
TGAI
TGAI
TGAI
TGAI
A
A
A
A
Yes 00104977
Yes 00114484
No
No
No
NO
Yes
No3/
12 Months
-------
Table A
Generic Data Requirements for Hexazinone
Test
Data Requirement Substance
§158.340 Toxicology
Subchronic Testinq (Cont'd)
82-4 - 90-Day Inhalation
82-5 - 90-Day Neurotoxicity
Chronic Testinq
83-1 - Chronic Toxicity
- Rodent
- Nonrodent
-------
Table A
Generic Data Requirements for Hexazinone (Cont'd)
Does EPA
Have Data To Timeframe
Test Use Satisfy This Bibliographic Must Additional for
Data Requirement Substance Pattern Requirement? Citation Data Be Submitted? Submission
S158.135 Toxicology
Mutaqenicity Testing (Cont'd)
84-2 - Other Mechanisms of TGAI A Yes 00130708 No
Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism PAIRA A Yes 00109237 No
I/An additional acute oral study in female rats is required to be submitted. If the results of this study indicate
a sex difference or that females may be more sensitive than males, then an additional acute dermal study in female
-------
Table B
Product-Specific Data Requirements for the Manufacturing-Use Products: Hexazinone
Data Requirement
Test
Substance
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic Must Additional
Citation Data Be Submitted?*/
Timeframe
Data
Submission
Part 158 - Subpart C - Product Chemistry
Product Identity and Composition
61-1 - Product Identity MP
and Disclosure of
Ingredients
61-2 - Description of Beginning MP
Materials and Manufac-
turing Process
3£ 61-3 - Discussion of Formation MP
'SK of Impurities
CN
o
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis MP
of Product Samples
62-2 - Certification of MP
Ingredient Limits
62-3 - Analytical Methods to MP
Verify Certified
Limits
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
No
No
No
No
No
No
Yes
Yes
YesV
Yes!/
YesV
Yes6/
00104969
00104969
No
No
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
-------
Table B
Product-Specific Data Requirements for the Manu IMC!.ur ing-Use Products: Hexazinone
Test
Data Requirement Substance
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Timef rame
Must Additional for
Data be Submitted?1/ Submission
Part 158 - Subpart C - Product Chemistry (Cont'd)
Physical and Chemical Characteristics (Cont'd)
63-4
63-7
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
- Odor
- Density, Bulk Density,
or Specific Gravity
- PH
- Oxidizing or Reducing
Action
- Flammability
- Explodability
- Storage Stability
- Viscosity -
- Miscibility
- Corrosion
M?
MP
MP
MP
MP
MP
MP
MP
MP
rt?
Yes
Yes
No
No
No
No
No
No
No
Mo
00104969
00104969
N/A
N/A
N/A
N/A
M.A
N/A
N/A
N/A
No
No
Yes8,9/
Yes8,10/
Yes8'11/
Yes8/12/
**w
Yes8,13/
YesS'W
Yes8/
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
Characteristics
Other Requirements:
64-1 - Submittal of Samples
N/A
N/A
N/A
No
-------
Table B
Product-Specific Data Requirements for the Manufacturing-Use Products: Hexazinone
Part 158 - Subpart C - Product Chemistry Footnotes
I/Although product chemistry data may have been submitted in the past, the Agency has determined that certain of
these data must be resubmitted. New requirements have been introduced and previously submitted data must be
updated. Therefore, many 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 and 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 company 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 used in the manufacture of each
product must be provided, along with information regarding the properties of those materials.
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.
5/Samples from five or more representative batches must be analyzed for the amount of active ingredient and each
impurity for which certified limits are required. Complete validation data (accuracy and precision) must be
submitted for each analytical method used.
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 estimate based on amounts of ingredients
used, etc.). Limits for impurities not associated with the active ingredient need to be provided only if they
are considered to be of toxicological significance, regardless of the concentration at which they are present.
Certifications must be submitted on EPA Form 8570-4 (Rev. 2-85).
7/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
8/Physicochemical characteristics (color, physical state, odor, specific gravity, pH, and stability) as required in
40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
9/Data required if the test substance is soluble or dispersible in water.
-------
Table B
Product-Specific Data Requirements for the Manufacturing-Use Products: Hexazinone
Part 158-Subpart C - Product Chemistry Footnotes (Cont'd)
10/Data required if the product contains an oxidizing or reducing agents.
11/Data required if the product contains combustible liquids.
12/Data required if the product is potentially explosive.
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.
ON
-------
II. LABELING APPENDICES
64
-------
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 contents 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 text. 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 estab-
lishment 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)]
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)]
r' 65
-------
SUMMARY-2
Item 68. 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
Minimum Type Size
All Capitals
"Keep Out of Reach
of Children"
Minimum Type Size
6 point
10 point
12 point
14 point
18 point
6
6
8
10
12
point
point
point
point
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 156.10(h ) (1)(ii ) ]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
warning
the child hazard
statement. [40 CFR 156.10(h ) (1) (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
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 156.10(h)(1)(i)]
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)]
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)(l)(iii)l
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)].
66
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SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the 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.
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 classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR Part 152, Subpart I. You will be
notified of the Agency's classification decision.
67
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SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. 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.
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 simul-
taneously. 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.
68
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SUMMARY-5
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.
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 use 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.
69
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SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT .
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
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
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
teagflfriq
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-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
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
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
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
PREFERRED
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
r^
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards,, include bee
caution where applicable.
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reent ry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F '
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
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
signal 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 from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
C\J
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Chapter 1—Environmental Protection Agency
§156.10 Labeling Requireaents
previously cited as 5162.10
(a) General — (1) Contents o'f the label. Every pesticide
product snail Dear a laoeL containing the information specified by
the Act and t;he regulations in this Part. The contents of a
label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragrapn (c) of this
section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
(e) of this section;
(v) The producing establishment number as prescribed in para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section?
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this section.
(2) Prom inane e and 1 eg ib i 1 i t y. (i) All words, statements,
graphic representations, designs or other information required on
the labeling by tha Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be placed
witn such conspicuousness (as compared with other words, state-
ments, designs, or graphic matter on tha labeling) and expressed
in such terms as to render it likaly to ba read and understood
by the ordinary individual undar customary conditions of purchase
and usa.
fii> All required, label, text m>»s»-?
(A) Ba sat in 6-point or largar type;
(B) Appear on a claac contrasting background; and
(C) Not ba obscured or crowded.
(3) Language to ba used. All required labal or labeling text
shall appaar xn tha English language. Howaver, tha Agency may
require or tha applicant may proposa additional text in other
languages as is considacad nacassary to protect tha public. When
additional taxt in anothar language is necessary, all labeling
requirements will b* applied equally to both tha English and
other-language versions of the labeling.
(4) Placement of Labal—(i) General. The label shall appear
on or be securely attached to the immediate container of tha
73
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pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
tnat <* label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. l£ the immediate
container is enclosed within a wrapper or outside container
through which the lanel cannot be clearly read, the label must
also be securely attached to su'ch outside wrapper or container,
if it is a part of the package as customarily distributed or
sold .
(ii) Tank cars and other bulk containers — (A) Transportat ion.
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers/ and left with the consignee at the time of.
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to $ 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-oesticidal claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A falsa or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
pro^uc* f~~ purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(vi) The name o£ a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
74
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(IK) Claims as to the safety of the pesticide or its ingredients
including statements sucn as "safe," "nonpo isonous," "noninjurious,'
"harmless" or "nontoxic to humans and pets" with or without sucn
a qualifying phrase as "when used as d i recr.aci" ; and
(x) Men-numerical and/or comparative statements on the safety
of che product, including but not limited to:
(A) ''Contains all natural ingredients";
(3) "Among the least toxic chemicals known"
(C) "Pollution approved"
(6) Final printed labeling. (i) Except as provided in .
paragraph (a)(6)(n) oc tnis section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legi&le reproductions or pnoto reductions will be
accepted for unusual labels such as those silk-screened directly
on^o glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under wnich the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to $ 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for *•*," "Distributed by
•••," or "Sold by •*•" to show that the name is not that of the
producer. . .
(d) Net weight or measure of contents. (1) The net weight or
measure of concent shall b« exclusive of wrappers or other
materials and shall be the average content unless explicitly
seated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in term* of liquid measure at 68*F (20*C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or seraisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces."
75
-------
(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation aoove minimum content or around an average is
per-ni ss i ble only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
seated minimum is not permitted. In no case shall the average
content of the packages in a shipment Call below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration numoer preceded by the. phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of-
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement—(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the terra _" inert
ingredients," or the singular forms of these terms when appropriate
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement "Inert Ingredients,
none* is not required for pesticides which contain 100 percent
active ingredients. tt«i««« fhe ingredient statement i* a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the Ingredient statement.
(2) Position of ingredient statement. (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside"container or wrapper through, which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label, permissic
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
76
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(3) Names to be used in ingredient statement. The name used
for each ingredient snail be the accepted common name, if there
is one, followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
estabLisned , the chemical name alone shall be used. In no case
will the use of a trademark or proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(4) Statements at percentages. The percentages of ingredients
shall be stated in terms of weight-to-weight. The sura of per-
cent ;es of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volum-e of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The psrcentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation 'between manu-
facturing batches, the value stated Cor each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quireraents :
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [datej."
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient statement
if he determines that such ingredient(s) may pose a'hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical cr cfccreic;! hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. With the exc»ption of the
child hazard warning statement,the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
77
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1
I "aia^s Ind'cafors
f
1
1 Oral 12
I 50
I
1
1
I
1
| 3«rm«l LD
1 "
1
I
1
I Cr* • '>• <
i i
i
F'ar" 50 Tnru
500 «g/t»g
F'aai .2 thru
Fra« 200
tnru 2000
• ltnl« 7 4ayt;
Irritation
p«rjl»tlng for
S*'**-* Irritation
at 72 nourj
:ar«cor'«j
III
f-3" 500 Thru
5000 mg/kg
F-o» 2 thru
20 •gy't 1 t«r
^re» 2.000 thru
20.000
MO corn«a( -opacity;
Irritation
rr»«rsl6l«
• Ithln 7 da>s
>«od«-at« Irritation
. at 72 now-j
i V
5000 «3/*,;
20 «g/t 'T.r
20.000
NO Irritation
0
HI l
-------
(£) Use of signal words. Use of any signal word(s) associated
with a higner Toxicicy Category is not permitted except when the
Agency determines that such Laoeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall rriore than one human hazard signal word appear on the
front panel of a label.
(11) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requ i rement.
(iii) Statement of practical treatment—(A) Toxicity
Category T7A statement of practical treatment (first aid or
other)snail appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement oC the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label .in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements snail be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of.purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square Inches
Over 30
Points
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children"
6
6
8
10
12
-------
( 2 ) Other required warr. ir.gs and precautionary stateme n t s
he
warnings and precautionary statements as required Delow snail appe^
togetner on the laoei uncier tr.e general heading "Precautionary
Statements" and under appropriate subneadings of "Hazard to Humans
and Domestic Animals," "Environmental Hazard" and "Physical or
Chem i ca 1 Hazard ."
(i) Hazard to humans and domestic animals. (A) Where a hazard
exists to numans or domestic a'nimals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(3) The following table depicts typical precautionary statements
These statements must be modified or expanded to reflect specific
hazards.
| Toxic I +1
Pr •cautionary sTaf««»»ntj o> toxic It} cat«gor>
Oral, tnfialatlon, or aamal _to»lclt>_
Skin and •*»• local «ff*eT»
11
III
Fatal (poisonous) If s«ailo»«d llnha/*d or
• oso.'b«d through shin). Oo not braath*
vapor ldu»T) or ipr«^ •liri. Oo nor g«r
In «T««. on tklnt or on clothing | front
p«n«i sr«t«n«nr of practical r*«aTM«nt
CorrotN*, c»u««» «y« and skin danag* lor
skin Irritation!. Oo not g«T In tj9i, on
Skin, or on clotn>nq. ««ar gogglas or face
snlald and rubb«r glow«» >h«n handling.
Harafut or fatal If s»allo»«•». on akin, or on clothing. ( Approer lar«|
fi--ir a'd stat«Mnti r«qulr«d.l. |
I
CauS«S •>• land Jkln) Irritation. Oo not
gat In ayas, on Skin, or on doming.
Harmful If »»allo»»d. (Apnroorlat* flrjr
aid stataiMnt raqulrad.1.
Harmful If »»allo»*4 |)nfcala«J or
tnrow^n rn« sklnl. Avo)4 br««tMn^ vapors
Idust or spray »l»tj. Avola1 contact vltn
ik'n («7«s or clotnln^). IAppro«rlaTa
first aid sfctaMMf
(NO pr«e*«tlo«««rY
Avoid contact «lth sfln, «y*s or clotnlng.
In cas« of contact !«w*dtatalj flush
«T«s or skin »ltn plan1> of >atar. G«t
••dlcal art*ntloA If Irritation persists.
pr«:a«tloi»«r>
a»«nts raqulrad.l
(ii) environmental hazards.
target organisms excluding
statements are required stating
appropriate precautions to avoid potential accident/
Where a hazard exists to non-
Humans and domestic animals, precautiona
the nature of the hazard and the
injury or
80
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damace. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intencea for outdoor use contains an active
ingredient with a mammalian ac-te oral 1.350 °- 10° or less, tr. e
statement "This Pesticide ; :> Toxic to Wildlife" is required.
'3) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC^^ of 1 ppm or less, the statement
" Tr. i s Pesticide is Toxic fp fish" 'is recuired.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD5Q of 100 mg/kg or less, or
a subacute dietary LC5Q of 500 ppm or less, the statement "This
Pesticide is Toxic to wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)* is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on the
flammabi1ity or explosive characteristics of the pesticide are
required as follows:
flu* point ! R»oulr»d t»»t
oo«ur« to
| IX'f r*t C— ^» »••-«• i«
oolnt «oev« 20*f ••« not ov«r «0*f or I f | n»M«oU. CO«T««T$ g«a«
rn« M«>« «rr«A«lo* l« «or» tn«i It In. 10*3 | »ro» K««r, so«r«s, an4 OMA M«*«. Oo nor
• r a d I trance of 6 la. fro* rn« M«M. | punerur* or l«cl««r«rt conraln«r. Expoiur* to
| r«oe«r*rur»> •oo«« t J0*f ««
AM orn«r 0r»«surl2«d contalnon .......". j Cent»nrt «/vij«r prMSur*. Oo not ut« or
| n««r n*«r or OO«M MM*. Qo not puncture or
| lncln«rar« container. Lipo»«r« to r««o«ra-
abo«« IJO'f «*
(8) »«ON«£SSL«IZEO
At or CMIO» 20'f .| Citrwnly tlAMCbtc. (••« «>«r ^o* tlra,
| soarkt, «n4 H4«r»4 «urf«c«s.
20*^ and nor o««r 80*' | 'i«-«a6l«. K««« a«ay fro* t««r and oo«« Ma
80*' and *ot ov«r ISO"f I Oo «o» «»• or itort n«ar na«r or open Max.
81
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( i.) Directions for Use— ( 1) General requirements— ( i ) Adequacy
and clarity of directions. Directions cor use must be stated in
terms wnicn can oe easily read and understood by the average
person Likely to use or to supervise the use of the pesticide.
When followed, directions must oe adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of direction^ for use. Directions may appear
on any porcion of tne laoel provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular." and
(C3 The Administrator determines that it is not necessary for
such directions to appear on the label.
(i i i) Exceptions to requirement for direction-for.use—(A)
Detailed directions for use may be omitted from laoeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
(JU The label clearly shows that the product is intended for
use~~only in manufacturing processes and specifies the type (s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(_3) The product will not come into the hands of the general
public except after incorporation into finished products; and
(4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions Cor use may be omitted from the labeling
of pesticide products Cor which sale is limited to ohysicians,
veterinarians, or druggists, provided that:
(_i) The label clearly states that the product is for use only
by physician* or veterinarians;
(2) The Administrator determines that such directions are not
nece"ssary to prevent unreasonable adverse effects on man or the
environment; and
H) The product is also a drug and regulated under the provisions
of "the Federal food, Drug and Cosmetic Act.
(C) Detailed directions for use nay be omitted from the labeling
oC pesticide products which are intended Cor use only by Cormulators
in preparing pesticides Cor sale to the public* provided that:
(1) There is information readily available to the Cormulators
on The composition, toxicity, methods oC use, applicable restriction
or limitations, and eCCectiveness oC the^product Cor pesticide
purposes ;
82
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(_2) The label clearly states that the product is intended for
use only in manufacturing, formulating, .-nixing, or repacking far
use as a pesticide and specifies the type(3) of pesticide products
invo Ived ;
( 1_) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and '•
(4_) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on raan or the
env i ronment.
(2) Contents 'of Directions for Use. The directions for use
shall include the following, under the headings "Directions for
Use" :
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application/ as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions Cor
dilution, if required, and typ«(s) of application apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of.
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This- heading must be
set in type of the same minimum sizes as required Cor the child
hazard warning (S«* Table in $ 162.10(h)(1)(iv).)
(x) Any limitation* or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(0) (Reserved]
(£) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision of a certified
applicator who is physically present.
83
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(F) Other pertinent information which the Administrator
determines to be necessary for tne protection of man and the
environment.
(3) Statement of Use Classification. By October 22, L976 , all
pesticide products must bear on; their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of S 162.10(j)(2) .
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility.
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s) classif led restricted shall bear statements
of restricted use classification on the front panel as described
below:
( i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in S 162.I0(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the front panel, a summary
statement ot the tern* of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicator*, the following statement is required: "For retail
sale to and use only by Certified Applicators oc persons under
their direct supervision and only foe those uses covered by the
Certified Applicator's certification." If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation
(k) Advertising. (Reserved)
(40 FR 28268, July 3, 1975; 40 FR 32329, Aug. I, 1975; 40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. *9, 19781
84
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Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
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.
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 incinerate
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.
85
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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.
86
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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."
87
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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 Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
( baqs )
Aerosol products
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
based on container type, listed
Container Type
bear container
below:
disposal instructions,
Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^, dispose of in the same manner.
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording)
}J Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
-------
III. BIBLIOGRAPHY APPENDICES
89
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BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
— a-rri-ving 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, and
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 explana-
tion. 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.
90
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BIBGUIDE-2
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.
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 fol-
lowing 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.
91
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Hexazinone Standard
MRID CITATION
00028733 E.I. du Pont de Nemours & Company (1976) Determination of Hexa-
zinone Metabolite C. Undated method. (Unpublished study re-
ceived-Jaft_21^1980 under 352-378; CDL:099225-A)
00028863 Serota, D.G.; Wolfe, G/W.; Cole, S.S.; et al. (1980) Teratology
Study in Rabbits: H-12932: Project No. 201-522. Final rept.
(Unpublished study including project no. 201-521, received Mar
14, 1980 under 352-378; prepared by Hazleton Laboratories Ameri-
ca, Inc., submitted by E.I. du Pont de Nemours & Co., Wilming-
ton, Del.; CDL:099298-A)
00028866 Holt, R.F.; Baude, F.J.; More, D.W. (1979) Hexazinone Livestock
Feeding Studies: Milk and Meat. (Unpublished study received Mar
14, 1980 under 352-378; submitted by E.I. du Pont de Nemours &
Co., Wilmington, Del.; CDL:099298-F)
00038868 Holt, R.F. (1980) Detennination of Hexazinone and Metabolite
Residues Using Nitrogen Selective Gas Chromatography. Undated
method. (Unpublished study received Jul 1, 1980 under 352-378;
submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.;
CDL:099514-E)
00047164 Heitmuller, T. (1976) Acute Toxicity of H-9877 to Embryos of East-
ern Oysters (Crassostrea virginica), to Grass Shrimp
(Palaemonetes pugio), and to Fiddler "Crabs (Uca pugila-
tor). (Unpublished study received Jul 25, 1979 under 352-
378; prepared by EG&G Bionomics, submitted by E.I. du Pont de
Nemours & Co., Wilmington, Del.; CDL:099674-B)
00047178 E.I. du Pont de Nemours & Company (1976) 96-Hour LC50 to Bluegill
Sunfish: Haskell Laboratory Report No. 409-76. (Unpublished
study received Aug 29, 1978 under 352-378; CDL-.099674-E)
00064260 Rhodes, R.C. (1974) Studies with Velpar Weed Killer in Water.
(Unpublished study received May 7, 1975 under 352-378; submit-
ted by E.I. du Pont de Nemours & Co., Wilmington, Del.; CDL:
110699-E)
00064261 Rhodes, R.C. (1974?) Decomposition of Velpar Weed Killer in Soil.
(Unpublished study received May 7, 1975 under 352-378; submit-
ted by E.I. du Pont de Nemours & Co., Wilmington, Del.; CDL:
110699-F)
00064262 Rhodes, R.C. (1974?) Mobility and Adsorption Studies with Velpar
Weed Killer on Soils. (Unpublished study received May 7, 1975
under, 352-378; submitted by E.I. du Pont de Nemours & Co.,
Wilmington, Del.; CDL:110699-G)
92
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OFFICE OF -PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of* the Data Base Supporting
Registrations Under the Hexazinone Standard
MRID CITATION
00064265 Rhodes, R.C. (1974?) Four Week Residue Studies with Velpar Weed
Killer and Bluegill Sunfish. (Unpublished study received May
7, 1975 under 352-378; submitted by E.I. du Pont de Nemours &
Co., Wilmington, Del.; CDL:110699-J)
00072663 Dudeck, S.H.; Bristol, K.L. (1980) Avian Dietary Toxicity (LC50)
Study in Bobwhite Quail: Project No. 201-547. Final rept. (Un-
published study received Jan 23, 1981 under 352-387; prepared by
Hazleton Laboratories America, Inc., submitted by E.I. du Pont
de Nemours & Co., Wilmington, Del.; CDL:244106-A)
00072664 Neary, D.G.; Douglass, J.E.; Bush, P.3.; et al. (1980) Movement of
Hexazinone in Forest Watersheds after a Hand Application of
Velpar: Gridball: Pellets for Site Preparation. Prog-
ress rept., Nov 1980. By U.S. Forest Service, Southeastern
Experiment Station, Coweeta Hydrologic Laboratory and Univ. of
Georgia, Extension Poultry Science Dept. and Institute of
Ecology. ?: USFS, SE. (FS-SE-1651-26(1); available from:
U.S. Government Printing Office; published study; CDL:244106-B)
00073988 Fink, R.; Beavers, J.B.; Brown, R. (1978) Final Report: Acute Oral
LD50—Bobwhite Quail: Project No. 112-121. (Unpublished study
received May 23, 1978 under 352-387; prepared by Wildlife Inter-
national, Ltd., and Washington College, submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:233989-A)
00078044 E.I. du Pont de Nemours & Company (1975?) Reports on Investigations
Made with Respect to Safety: [Velpar Weed Killer]. Summary of
study 095980-C. (Unpublished study received Mar 22, 1976 under
352-EX-91; CDL:095980-B)
00078047 Rhodes, R.C. (1975) Letter sent to 324 File dated Aug 12, 1975:
Uptake and metabolism studies with 14:C-DPX-3674 on sugarcane
in the greenhouse. (Unpublished study received Mar 22, 1976
under 352-EX-91; submitted by E.I. du Pont de Nemours & Co.,
Wilmington, Del.; CDL:095980-E)
00079203 Goldenthal, E.I.; Trumball, R.R. (1981) Two-year Feeding Study in
Mice: IRDC No. 125-026. (Unpublished study received Jul 30,
1981 under 352-378; prepared by International Research and De-
velopment Corp., submitted by E.I. du Pont de Nemours & Co.,
Wilmington, Del.; CDL:245676-A; 245677)
00093716 Piccirillo, V.J.; Carr, S.B. (1978) Final Report: Subacute Dietary
LC:50 in Mallard Ducks: Project No. 201-518. (Unpublished
study received Feb 1, 1979 under unknown admin, no.; prepared
by Hazleton Laboratories America, Inc., submitted by E.I. du
Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:246601-A)
93
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Hexazinone Standard
MRID CITATION
00101574 Interregional Research Project No. 4 (1982) [Residue Studies of
Hexazinone on Blueberries and Methomyl on Sugarcane]. (Compi-
lation; unpublished study--received May 17, 1982 under 2E2687;
CDL:070861-A)
00104845 E.I. du Pont de Nemours & Co., Inc. (1979) Results of Tests on the
Amount of Residue Remaining on Treated Crop: [Hexazinone plus
Metabolites]. (Compilation; unpublished study received May 24,
1979 under 9G2214; CDL:098309-C)
t
00104846 Rapisarda, C. (19??) Metabolism of 14C-labeled Hexazinone in Al-
falfa: Doc. No. HME 12-79. (Unpublished study received May 24,
1979 under 9G2214; submitted by E.I. du Pont de Nemours & Co.,
Inc., Wilmington, DE; CDL:098309-D)
00104969 E.I. du Pont de Nemours & Co., Inc. (19??) [Chemistry Data on Du
Pont Velpar Weed Killer and DPX-367641. (Compilation; unpub-
lished study received Dec 5, 1973 under 352-EX-85; CDL:223386-A)
00104972 Dale, N. (1973) Oral LD50 Test: Haskell Laboratory Report No. 392-
73. (Unpublished study received Dec 5, 1973 under 352-EX-85;
submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington,
DE; CDL:223386-D)
00104974 Morrow, R. (1973) Skin Absorption Toxicity ALD and Skin'irritancy
Test: Haskell Laboratory Report No. 503-73. (Unpublished study
received Dec 5, 1973 under 352-EX-85; submitted by E.I. du Pont
de Nemours & Co., Inc., Wilmington, DE; CDL:223386-F)
00104975 Sarver, J. (1973) One-hour Acute Inhalation Toxicity: Haskell
Laboratory Report No. 305-73. (Unpublished study received Dec
5, 1973 under 352-EX-85; submitted by E.I. du Pont de Nemours &
Co., Inc., Wilmington, DE; CDL:223386-G)
00104977 Sherman, H.; Carroll, K.; Adams, L.; et al. (1973) Ninety-day Feed-
ing Study in Rats with SYM-triazine-2,4 (lH,3H)-dione, 3-cyclo-
hexyl-l-methyl-6-dimethylamino-[INA-3674!: Haskell Laboratory
Report No. 235-73. (Unpublished study received Dec 5, 1973
under 352-EX-85; submitted by E.I. du Pont de Nemours & Co.,
Inc., Wilmington, DE; CDL:223386-I)
00106003 Dashiell, 0.; Henry, J. (1982) Eye Irritation Test in Rabbits—
EPA Pesticide Registration [INA-3674-1221: Haskell Laboratory
Report No. 251-82. (Unpublished study received Jul 7, 1982
under 352-399; submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, DE; CDL:247801-A)
94
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Hexazinone Standard
MRID CITATION
00106004 Dashiell, 0.; Hinckle, L. (1982) Skin Irritation Test on Rabbits
for EPA Pesticide Registration: Haskell Laboratory Report
No. 203-82. (Unpublished study received Jul 7, 1982 under 352-
399; submitted by E.I. du Pont de Nemours & Co., Inc., Wilming-
ton, DE; CDL:247802-A)
00108638 Kaplan, A.; Frazier, C.; Adams, L.; et al. (1977) Long-term Feeding
Study in Rats with ... (INA-3674): Haskell Laboratory Report
No. 353-77. (Unpublished study received Aug 29, 1978 under
352-378; submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, DE; CDL:097323-C)
00109237 Rapisarda, C. (1980) Metabolism of 14C-labeled Hexazinone in the
Rat: Document No. AMR-79-82. (Unpublished study received Jul
20, 1982 under 352-378; submitted by E.I. du Pont de Nemours &
Co., Inc., Wilmington, DE; CDL:247874-A)
00114039 E.I. du Pont de Nemours & Co., Inc. (1978) Investigations Made
with Respect to Residue Chemistry: [Velpar]. (Compilation;
unpublished study received Aug 29, 1978 under 352-378; CDL:
097321-E)
00114484 Sherman, H.; Dale, N.; Adams, L.; et al. (1973) Three-month Feeding
Study in Dogs with Sym Triazine-2,4(lH,3H)-dione, 3-cyclohexyl-
l-methyl-6-dimethylamino-[INA-3674!: Haskell Laboratory Report
No. 408-73. (Unpublished study received Apr 3, 1980 under 352-
378; submitted by E.I. du Pont de Nemours & Co., Inc., Wilming-
ton, DE; CDL:140051-A)
00116269 Schneider, P. (1976) 48-hour LC50 to Daphnia magna: Haskell Labo-
ratory Report No. 262-76. (Unpublished study received Dec 30,
1977; under 352-387; submitted by E.I. du Pont de Nemours & Co.,
Inc., Wilmington, DE; CDL:232556-A; 235401)
00118050 E.I. du Pont de Nemours & Co., Inc. (1982) Data Supporting Amend-
ment of Velpar Weed Killer Use on Alfalfa and Adding Velpar L
Weed Killer Use on Alfalfa. (Unpublished study received Nov 15,
1982 under 352-378; CDL:248831-A)
00118509 E.I. du Pont de Nemours & Co., Inc. (1982) Product Chemistry:
[Hexazinone]. (Compilation; unpublished study received Dec 17,
1982 under 352-399; CDL:071264-A)
00126127 E.I. du Pont de Nemours & Co., Inc. (1983) Results of Tests on the
Amount of Residue Remaining on Treated Crop: [Hexazinone].
(Compilation; unpublished study received Feb 28, 1983 under
352-378; CDL:071438-A)
95
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Hexazinone Standard
MRID CITATION
00130708 Ford, L. (1983) Unscheduled DNA Synthesis/Rat Hepatocytes in vitro:
[INA-3674-112]: Haskell Lab Report No. 766-82. (Unpublished
study received Jul 11, 1983 under 3S2-37&; submitted by E.I. du
Pont de Nemours & Co., Inc., Wilmington, DE; CDL:251041-A)
00130709 Vlachos, D.; Martenis, J.; Horst, A. (1982) In vitro Assay for
Chromosome Aberrations in Chinese Hamster Ovary (CHO) Cells:
Haskell Lab Report No. 768-82. (Unpublished study received Jul
11, 1983 under 352-378; submitted by E.I. du Pont de Nemours &
Co., Inc., Wilmington, DE; CDL:251042-A)
00131355 Farrow, M.; Cortina, T.; Zito, M.; et al. (1982) In vivo Bone Mar-
row Cytogenetic Assay In Rats: HLA Project No. 201-573. Final
rept. (Unpublished study received Jul 11, 1983 under 352-378;
submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington,
DE; CDL:251043-A)
00138226 E.I. du Pont de Nemours & Co., Inc. (1984) Residue Chemistry Data
Supporting the Use of Velpar L Weed Killer for Control of Unde-
sirable Woody Plants in Rangeland. (Compilation; unpublished
study received Apr 4, 1984 under 352-392; CDL:252954-A)
40397501 Mullin, L. (1987) Teratogenicity Study of INA-3674 in Rats: Haskell
Laboratory Report No. 748-86. Unpublished study prepared by
E.I. du Pont de Nemours and Co., Inc. 186 p.
40826201 Russel, J. (1977) Mutagenicity Evaluation of S-triazine-2,4(lH,3H)
-dione, 3-cyclohexyl-6-dimethyl-amion-l-methyl in Salmonella
Typhimurium: Haskell Laboratory Report No. 588-77. MR No.
0581-693. Revised Apr 7, 1986 by L.B. Rickard. Prepared by E.I.
du Pont de Nemours and Company, Inc. Haskell Laboratory for
Toxicology and Industrial Medicine. 24 p.
96
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IV. FORMS APPENDICES
97
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OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3(CJ(2}(8) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With raped re tf* raqmrwnwt to aibm* '>*trie- dtt impood by tt» FIFHA •man 3(C)12J(B) Mtic* amtwMd «tft* r*
GIMOMC* OocuoMnt. I urn rwondmf M rt« foUeann mwm«r
O 1. I writ mibmit te» M • timty mnwr to Btofy rtx (oilowm^ nquiramvm. If Hit tat prnmton I wiB im dt^ult from (or «r» nit
in) tnt H«»Ml«ion Gaidiimi or tta Praracals cantwMd n dtt Rtovn o* Exp«t Gnxipi to rtw Own CM Groug. OECO
«tin« Prearwnm*. I «ndo» ttM pretocote tfw I »«H IOK
Dt
unow FIFRA i
imd » EPA by:
13
-------
Aocrovai NO. 2070-0057
Expiration Oate 11/30/89
:C DATA
Product e«o;i station Number: _
*
flecistranc's Nene and Address:
AS an authorized reptesenutive of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the term* of the Notice fro* B>A dated
____________ concerning a requirement for submission of "generic* dau on the
active ingredient _____________ named under PIFRA Section 3
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
S158.340
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
.
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assiqned
101
-------
PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Registration Standard for
Registration
Guideline No.
Part 158
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
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific qravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached )
(For EPA Use Only)
MRID Numbers
Assigned
EPA Form 8580-4
100
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OMB A-pproval Ho. 20:0-0557
Expires 11/30/89
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