United States Prevention, Pesticides EPA 738-R-94-022
Environmental Protection And Toxic Substances September 1994
Agency (7508W)
4>EPA Reregistration
Eligibility Decision (RED)
Hexazinone
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case hexazinone. The
enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the
data base of this chemical, its conclusions of the potential human health and environmental
risks of the current product uses, and its decisions and conditions under which these uses and
products will be eligible for reregistration. The RED includes the data and labeling
requirements for products for reregistration. It also includes requirements for additional data
(generic) on the active ingredient to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED." This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the receipt of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Franklin Gee at (703) 308-8008. Address any questions on required generic data to the
Special Review and Reregistration Division representative Andrew Ertman at (703) 308-8063.
Sincerely yours,
Louis P. True, Jr., Acting Director
Special Review and
Reregistration Division
Enclosures:
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE" A Product Specific Data Call-
in is enclosed with this RED and must be completed and submitted within 90 days of receipt
of this package. The response consists of a "Data Call-in Response" form and a
"Requirements Status and Registrant's Response" form. Additional generic may also be
required to confirm or support the assessment of the active ingredient. If generic data are
required, Generic Data Call-Ins are being sent only to certain manufacturing use registrants.
Generic Data Call-Ins are not being sent to end use product registrants. However, please note
that instructions for completing the Data Call-Ins, which are incorporated as an Appendix to
the RED, may address both generic and product specific data. If you are an end use
registrant, be sure to follow the instructions for product specific data.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension
requests will be granted for the 90-day response. Time extension requests may be submitted
only with respect to actual data submissions. Requests for data waivers must be submitted as
part of the 90-day response. Requests for time extensions should be submitted in the 90-day
response, but certainly no later than the 8-month response date. All data waiver and time
extension requests must be accompanied by a full justification. All waivers and time
extensions must be granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You
must submit the following items for each product within eight months of the RED
issuance date (the cover letter date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in
item 5.
b. Five copies of draft labeling which complies with the RED and current
regulations and requirements. Only make labeling changes which are required by the
RED and current regulations (40 CFR 156.10) and policies. Submit any other
amendments (such as formulation changes, or labeling changes not related to
reregistration) separately. You may delete uses which the RED says are ineligible for
reregistration. For further labeling guidance, refer the labeling section of the EPA
publication "General Information on Applying for Registration in the U.S., Second
Edition, August 1992" (available from the National Technical Information Service,
publication #PB92-221811; 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the
EPA identifier (MRID) numbers. Before citing these studies, you must make sure
that they meet the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic
and each alternate formulation. The labeling and CSF which you submit for each
product must comply with P.R. Notice 91-2 by declaring the active ingredient as the
nominal concentration. You have two options for submitting a CSF: (1) accept the
standard certified limits (see 40 CFR §158.175) or (2) provide certified limits that are
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supported by the analysis of five batches. If you choose the second option, you must
submit or cite the data for the five batches along with a certification statement as
described in 40 CFR §158.175(e). A copy of the CSF is enclosed; follow the
instructions on its back.
e. Certification With Respect to Citation of Data. Complete and sign this form
(EPA form 8570-29) for each product. Cite-all is not a valid option for
reregistration.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE
Comments pertaining to the content of the RED may be submitted to the address shown
in the Federal Register Notice which announces the availability of this RED.
5. WHERE TO SEND ALL PCI RESPONSES (90-DAY) AND APPLICATIONS
FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-0266)
Office of Pesticide Programs (H7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-0266)
Office of Pesticide Programs (H7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are
not complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
HEXAZINONE
LIST A
CASE 0266
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
HEXAZINONE REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 5
D. Data Requirements 5
E. Regulatory History 6
III. SCIENCE ASSESSMENT 7
A. Physical Chemistry Assessment 7
B. Human Health Assessment 8
1. Toxicology Assessment 8
a. Acute Toxicity 8
c. Chronic toxicity 9
d. Carcinogenicity 10
e. Developmental Toxicity 11
f. Reproductive Toxicity 12
g. Mutagenicity 12
h. Metabolism 13
i. Other Toxic Endpoints 14
j. Reference Dose (RfD) 14
2. Exposure Assessment 15
a. Dietary Exposure 15
b. Occupational and Residential Exposure 17
3. Risk Assessment 19
a. Dietary 19
b. Occupational and Residential 20
4. Data Requirements 21
C. Environmental Assessment 21
1. Environmental Fate 21
a. Environmental Chemistry, Fate and Transport Data .... 21
b. Environmental Fate Assessment 24
2. Ecological Effects 25
a. Ecological Effects Data 25
(1) Terrestrial Data 25
(2) Aquatic Data 25
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(3) Non-Target Insects Data 27
(4) Non-Target Plant Data 28
b. Ecological Effects Risk Assessment 29
3. Data Requirements 46
4. Summary of LOG Exceedance and Risk Characterization 47
a. Ecological Effects 47
b. Ground Water 47
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 48
A. Determination of Eligibility 48
1. Eligibility Decision 49
2. Eligible and Ineligible Uses 49
B. Regulatory Position 49
1. Tolerance Reassessment 49
2. Restricted Use Classification 52
3. Reference Dose 52
4. Cancer Classification 52
5. Risk Mitigation 52
6. Spray Drift Label Advisory 53
7. Endangered Species Statement 53
8. Labeling Rationale 54
a. Compliance with Worker Protection Standard (WPS) ... 54
V. ACTIONS REQUIRED BY REGISTRANTS 57
A. Manufacturing-Use Products 57
1. Additional Generic Data Requirements 57
2. Labeling Requirements for Manufacturing-Use Products 58
B. End-Use Products 58
1. Additional Product-Specific Data Requirements 58
2. Labeling Requirements for End-Use Products 58
a. Worker Protection Standard (WPS) 58
b. Ground Water Labeling 58
c. Surface Water Labeling 59
3. Other Ground Water Requirements 59
4. Risk To Non-Target Plants 59
C. Existing Stocks 59
VI. APPENDICES 61
APPENDIX A. Table of Use Patterns Subject to Reregistration 63
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 105
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Hexazinone 117
APPENDIX D. List of Available Related Documents 135
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APPENDIX E 139
PR Notice 86-5 141
PR Notice 91-2 159
APPENDIX F. Combined Generic and Product Specific Data Call-In 165
Attachment 1. Chemical Status Sheets 185
Attachment 2. Combined Generic and Product Specific Data Call-in
Response Forms (Form A inserts) Plus Instructions 189
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and Instructions
195
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 203
Attachment
1. EPA Acceptance Criteria 207
Attachment 2. List of All Registrants Sent This Data Call-in (insert) Notice
221
Attachment 3. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 223
APPENDIX G. FACT SHEET 233
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HEXAZINONE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
James Saulmon
Eric Maurer
Margaret Cogdell
Health Effects Division
Bill Dykstra
Susan Hummel
Bart Suhre
Jeff Evans
Jennifer M. Wintersteen
Charles Frick
Environmental Fate and Effects Division
Conchi Rodriguez
Paul Mastradone
Gail Maske
Estella Waldman
Henry Nelson
Kathy Monk
Registration Division
Eugene Wilson
Joanne Hayes
Special Review and Reregistration Division
Andrew Ertman
Walt Waldrop
Niloufar Nazmi
Biological Analysis Branch
Economic Analysis Branch
LUIS Staff
Toxicology Branch
Chemistry Branch
Chemistry Branch
Occupational and Residential Exposure
Branch
Science Analysis Branch
Chemical Coordination Branch
Ecological Effects Branch
Environmental Fate and Groundwater
Branch
Environmental Fate and Groundwater
Branch
Environmental Fate and Groundwater
Branch
Environmental Fate and Groundwater
Branch
Science Analysis and Coordination
Staff
Fungicide-Herbicide Branch
Registration Support Branch
Reregistration Branch
Reregistration Branch
Special Review Branch
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Office of Compliance Monitoring:
Rose Lew
Office of Water:
Amal Mahfouz
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
DRES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium
specific (i.e. drinking water) lifetime exposure at which adverse, non
carcinogenic health effects are not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
GLC Gas Liquid Chromatography
GRAS Generally Recognized As Safe as designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to
municipalities and other organizations when emergency spills or contamination
situations occur.
HOT Highest Dose Tested
in
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GLOSSARY OF TERMS AND ABBREVIATIONS
LC,
50
LD
50
LDlo
LEL
LOG
LOEL
MCLG
mg/L
MP
MPI
MOE
MRID
N/A
NPDES
NOEL
OPP
Median Lethal Concentration. A statistically derived concentration of a
substance that can be expected to cause death in 50% of test animals. It is
usually expressed as the weight of substance per weight or volume of water, air
or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Level of Concern
Lowest Observed Effect Level
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the
Agency to regulate contaminants in drinking water under the Safe Drinking
Water Act.
Micrograms Per Gram
Milligrams Per Liter
Manufacturing-Use Product
Maximum Permissible Intake
Margin Of Exposure
Master Record Identification (number). EPA's system of recording and
tracking studies submitted.
Not Applicable
National Pollutant Discharge Elimination System
No Observed Effect Level
Office of Pesticide Programs
IV
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GLOSSARY OF TERMS AND ABBREVIATIONS
PADI Provisional Acceptable Daily Intake
PAM Pesticide Analytical Method
PPE Personal Protective Equipment
ppb Parts Per Billion
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer
Risk Model
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The concentration at which a substance produces a toxic
effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
TLC Thin Layer Chromatography
WPS Worker Protection Standard
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EXECUTIVE SUMMARY
This Reregistration Eligibility Decision document (RED) addresses the reregistration
eligibility of the pesticide hexazinone, 3-cyclohexyl-6-(dimethylamino)-l-methyl-S-triazine-
2,4-(lH,3H)-dione.
Hexazinone is a triazine-dione herbicide registered for use on alfalfa, pasture and range
grasses, pineapples, sugarcane, and blueberries. It is also registered for use on ornamental
plants, forest trees, and non-crop areas. Hexazinone is registered for pre-emergent, post-
emergence, layby, directed spray, and basal soil applications. There are presently 20 end-use
hexazinone products and one technical (manufacturing-use) product registered.
Hexazinone was first registered by the Agency in November, 1975 for general weed
control in non-cropland areas. A Registration Standard for Hexazinone was issued in
February, 1982 (NTISf PB87-110292) that identified data gaps according to guidelines then in
place. After issuance of the 1982 Standard, new uses for hexazinone were established on
blueberries, rangeland, pasture grasses, and pineapple. A second Registration Standard was
issued in September, 1988 (NTIS# PB89-126080). The 1988 Standard summarized available
data supporting the registration of products containing hexazinone as the active ingredient and
required additional product chemistry, residue chemistry, toxicology, ecological effects, and
environmental fate data.
The Agency has now completed its review of the hexazinone target data base including
data submitted in response to the 1988 Registration Standard and has determined that the uses
of hexazinone as currently registered will not cause unreasonable adverse effects to humans or
the environment. All uses of hexazinone are eligible for reregistration. Existing tolerances
for blueberries, pineapple and sugarcane were reassessed. Tolerances for several other crops
and commodities could not be reassessed; however, enough data were available to conduct a
risk assessment. The Agency believes that existing tolerances are protective until data are
available for reassessment. All uses of hexazinone that did not have tolerances reassessed at
this time are eligible for reregistration. The Agency is requiring additional studies in the
residue chemistry, ecological effects, and environmental fate disciplines that will be called in
on a confirmatory basis. The following data are required: residue analytical methods
(ruminant only), magnitude of the residue grass hay and alfalfa seed screenings, magnitude of
the residue in meat/milk, storage stability (alfalfa and metabolite C for grass), rotational
crops, seed germination/seedling emergence, vegetative vigor, a batch equilibrium study,
aquatic sediment dissipation, a prospective groundwater monitoring study and spray drift data.
OPP's Carcinogenicity Peer Review Committee classified the carcinogenic potential of
hexazinone as "Group D" on July 27, 1994. The Peer Review Committee concluded that the
evidence was inadequate and could not be interpreted as showing either the presence or
absence of a carcinogenic effect. However, further testing is not likely to provide any
additional clarification. Based on these findings, the Agency cannot conclude that hexazinone
has been found to induce cancer within the meaning of the Delaney clause and therefore food
VI
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and feed additive regulations are not barred by the Delaney clause of the Federal Food Drug
and Cosmetic Act.
On February 11, 1993, the OPP Reference Dose Committee established a Reference
Dose (RfD) for hexazinone of 0.05 mg/kg/day based upon a No Observed Effect Level
(NOEL) of 5 mg/kg/day from a one-year feeding study in dogs. An Uncertainty Factor (UF)
of 100 was used to account for the inter-species extrapolation and intra-species variance. The
Anticipated Residue Contribution (ARC) for the general U.S. population was calculated by
using anticipated residues. The ARC was determined to be 7% of the RfD. The subgroup
most highly exposed, non-nursing infants (< 1 yr) has an ARC from all uses of 40% of the
RfD. A Health Advisory (HA) was issued by the Agency's Office of Water in August, 1988.
A lifetime HA was set at 0.21 mg/L, or 200 ppb.
Hexazinone meets the Agency's exposure criteria for requiring both handler (mixer/
loader/applicator) and postapplication/reentry data. However, because there are no acute or
chronic toxicological endpoints of concern with the exception of acute eye irritation (Toxicity
Category I), handler and postapplication/reentry data are not required to support the
reregistration of hexazinone. Because hexazinone is in Toxicity Category I for primary eye
irritation, a 48 hour Restricted Entry Interval (REI) is required.
Hexazinone exceeds the Levels of Concern (LOCs) for both terrestrial and aquatic
plants. The unrefined risk quotients range from 4.6 to 2142.8 depending on the application
rate. Hexazinone also exceeds the LOG for small mammals at several of the higher
application rates, however, using typical residues as the EEC estimates, the risk quotients
range from < 0.1 to 0.6.
Based on laboratory data, hexazinone appears to be persistent and mobile in soil and
aquatic environments. Field and forestry dissipation data confirm this. In addition,
hexazinone was reported in runoff water (80 to 140 ppb) up to 6 months posttreatment in the
forestry dissipation study. Therefore, field and laboratory data are consistent and indicate that
hexazinone may be of concern for groundwater and surface water contamination.
Groundwater detections have been reported in Hawaii (0.06-0.72 ppb), Florida (0.12-2.90
ppb), Maine (0.2-29 ppb), and North Carolina (0.74-34 ppb); levels well below the Health
Advisory (200 ppb).
Hexazinone exceeds the following Levels of Concern (LOCs) for groundwater:
groundwater quality, and non-target aquatic and terrestrial plants. Hexazinone exhibits many
of the properties and characteristics associated with chemicals that have been detected in
ground water. Considering the mode of activation of the chemical; i.e., rainfall within two
weeks of an application, there is a strong possibility of movement to ground water, especially
in vulnerable areas. For these reasons, hexazinone use is likely to have a significant impact on
ground-water quality. In areas where irrigation water is contaminated with hexazinone, or
where ground water discharges to surface water, hexazinone residues in ground water could
pose a threat to plants.
vn
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Following discussions with the technical registrant, duPont, several risk mitigation
measures were agreed upon. These measures include a ground water label advisory, Agency
notification of any domestic hexazinone detections in ground water, submission to the Agency
of a report compiled by duPont and the state of Maine regarding ground water contamination,
the development and submission of educational materials regarding product stewardship (with
an emphasis on groundwater issues) and a lowering of the maximum application rate from
13.5 Ib ai/acre to 8 Ib ai/acre.
Before reregistering the products containing hexazinone, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling
be submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing. After reviewing these data and any
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the
Agency will reregister a product. Those products which contain other active ingredients will
be eligible for reregistration only when the other active ingredients are determined to be
eligible for reregistration.
vin
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
of an active ingredient and the generation and submission of data to fulfill the requirements.
The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for registration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying
a pesticide's registration. The purpose of the Agency's review is to reassess the potential
hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether the pesticide
meets the "no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of hexazinone. The document consists of six sections. Section I is the
introduction. Section II describes hexazinone, its uses, data requirements and regulatory
history. Section III discusses the human health and environmental assessment based on the
data available to the Agency. Section IV presents the reregistration decision for hexazinone.
Section V discusses the reregistration requirements for hexazinone. Finally, Section VI is the
Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Document:
• Common Name: Hexazinone
• Chemical Name: 3-cyclohexyl-6-(dimethylamino)-l-methyl-S-
triazine-2,4-(lH,3H)-dione
• Chemical Family: Triazine-dione
• CAS Registry Number: 51235042
• OPP Chemical Code: 107201
• Empirical Formula: C12H20N402
• Trade and Other Names: Velpar
• Basic Manufacturer: DuPont Agricultural Products
B. Use Profile
The following is information on the current registered uses with an overview of
use sites and application methods. A detailed table of the uses of hexazinone can be
found in Appendix A.
Type of Pesticide: herbicide
Mechanism of Action: l,3,5-Triazine-2,4-dione contact herbicide, inhibitor of
photosynthesis
Use Groups and Sites:
TERRESTRIAL FOOD CROP
Blueberry
TERRESTRIAL FOOD AND FEED CROP
Pineapple, sugarcane
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TERRESTRIAL FEED CROP
Agricultural rights-of-way/fencerows/hedgerows, alfalfa, grass forage/fodder/
hay, pastures, rangeland
TERRESTRIAL NON-FOOD CROP
Agricultural fallow/idleland, Christmas tree plantations, industrial areas
(outdoor), nonagricultural rights-of-way/fencerows/hedgerows, nonagricultural
uncultivated areas/soils, recreational areas
AQUATIC NON-FOOD INDUSTRIAL
Drainage systems
FORESTRY
Conifer release, forest plantings (reforestation programs), forest trees (all or
unspecified)
Pests: Alexandergrass, aspen, barnyardgrass, blackgum, blue mustard, bristly
foxtail, brown panicum, chickweed, common groundsel, dallisgrass, deerbrush
caenothus, dogbane, dogwood, elm, fiddleneck, filaree, fireweed, fleabane,
fuzzy crotalaria, goosegrass, Great Plains yucca, green ash, guineagrass,
hackberry, hawthorn, heath aster, henbit, hickory, honeysuckle, Jim Hill
mustard, jimsonweed, junglerice, juniper, lambsquarters, lantana, London
rocket, lotebrush condalia, manzanita, mexicantea, minerslettuce,
morningglory, oak, osageorange, Pennsylvania smartweed, perennial bluegrass,
periwinkle, persimmon, pigweed, plantain, purslane, radiate fingergrass,
ricegrass paspalum, sandbur, sensitive plant, shepherdspurse, showy crotalaria,
signalgrass, small broomrape, smartweed, snowbrush caenothus, sour
paspalum, sowthistle, spanishneedles, speedwell, swollen fingergrass, tarweed
cuphea, Texas millet panicum, Texas whitebrush, vaseygrass, wild carrot, wild
mustard, wild parsnip, willow, willowweed, woodsorrel, yellow foxtail, yellow
rocket. (Partial control or suppression only: curly dock, dandelion, dogwood,
marestail, milkweed, nutsedge, pricklylettuce, quackgrass, redcedar, red maple,
ryegrass, sumac, sweetgum, trumpet creeper).
Formulation Types:
Granular--10 to 75%
Pelleted/tableted-10 to 90%
Emulsifiable concentrate—25%
Liquid ready to use—1.25%
Soluble concentrate/solid—90%
Technical Grade Active Ingredient—98.7%
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Methods and Rates of Application:
Granular In any season, at pre- or postplant, pre- or posttransplant, or when
needed, broadcast by aircraft or ground equipment or granule applicator at 1.25
to 12 Ib active ingredient (ai)/acre. In summer or winter, apply spot soil
treatment by hand at 0.005 Ib ai/1" stem diameter. At pre- or postplant, apply
band treatment by ground equipment at 2 Ib ai/acre.
Pelleted/tableted In any season or at preharvest, apply spot soil treatment by
hand at 0.002 to 0.005 Ib ai/1" stem diameter. In summer, winter, or at
preharvest, apply soil treatment by hand at 3.8 to 5.8 Ib ail acre. In any season
or when needed, broadcast by hand, aircraft or ground equipment at 2 to 12 Ib
ai/acre. When needed, apply tree injection treatment by appropriate equipment.
Emulsifiable concentrate In any season, at dormant, delayed dormant, stubble,
or seed crop stages, or when needed, spray by sprayer, boom sprayer, ground,
or aircraft equipment at 1 to 8 Ib ai/acre. In fall, winter, or spring, at pre- or
postplant, or posttransplant, apply band treatment by sprayer, boom sprayer, or
ground equipment at 2 to 3 Ib ai/acre. In any season, in Feb to June, at
preharvest, or when needed, apply basal spray by hand held sprayer at 0.002 Ib
ai/1" stem diameter or 4 to 6 Ib ai/acre. In Feb to June, apply bark cut
treatment by sprayer. In Feb to June, fall, winter, or spring, at pre- or
postplant, or when needed, broadcast by sprayer, boom sprayer, ground or
aircraft equipment, or hand held sprayer at 2 to 12 Ib ai/acre. In Feb to June,
summer, or winter, apply soil treatment (specialized) by hand held sprayer at 6
to 12 Ib ai/acre. In Feb to June or summer, treat trees by injection with
appropriate equipment at 0.0005 lb/4" interval.
Liquid ready to use In summer, fall, or winter, apply basal spray by hand held
sprayer at 0.2 to 0.3 gal ai/1,000 sq ft. In summer, fall, or winter, apply
directed spray by sprayer at 6.6 to 8.3 gal ail acre. When needed, broadcast by
hand held sprayer, sprayer, or boom sprayer at 10 to 12.45 gal ai/acre.
Soluble concentrate/solid At postemergence, layby, or when needed, apply
directed spray by sprayer, boom or knapsack sprayer at 0.9 to 13.5 Ib ai/acre.
In spring, summer, at stubble, pre- or postemergence, dormant, or seed crop
stages, or when needed, spray by boom sprayer, aircraft equipment, or sprayer
at 0.9 to 5.4 Ib ai/acre. In any season, at pre- or postplant, pre- or
postemergence, postharvest, stubble, or dormant stages, or when needed,
broadcast by boom or hand held sprayer, ground or aircraft equipment at 0.9 to
13.5 Ib ai/acre. In fall, winter, or spring, at pre- or postplant, apply band
treatment by boom sprayer, sprayer, or ground equipment at 0.9 to 2.7 Ib
ai/acre. When needed, apply spot treatment by sprayer or knapsack sprayer at
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1.8 to 3.6 Ib ai/acre. When needed, apply basal spray by hand held or power
sprayer at 7.2 Ib ai/acre.
Use Limitations:
Do not apply through any type of irrigation system. Do not apply within 30 to
60 days before grazing, harvest, or feeding.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
hexazinone. These estimates are derived from a variety of published and proprietary
sources available to the Agency. The data, reported on an aggregate and site (crop)
basis, reflect annual fluctuations in use patterns as well as the variability in using data
from various information sources.
The table below summarizes the pesticides use by site.
Site1
Alfalfa
Blueberry
Pineapple3
Rangeland
Sugarcane
Woodland
Other
Total
Acres Grown2
(000)
25,048
22
29
N/A
875
483,319
N/A
Acres Treated
(000)
200-450
2-5
Unknown
80-650
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E. Regulatory History
Hexazinone is the accepted common name for the chemical 3-cyclohexyl-6-
(dimethylamino)-l-methyl-1,3,5 triazine-2,4(lH,3H)-dione. Hexazinone is a
proprietary chemical of E.I. duPont de Nemours and Company, Inc. which is the sole
producer and primary registrant of this broad spectrum herbicide. Hexazinone was
first registered by the Agency in November 1975 for general weed control in non-
cropland areas. Use in the culture of Christmas trees and forest trees was added in
1977. Use patterns for the culture of sugarcane and alfalfa were conditionally
registered in 1980 and 1981, respectively.
In February 1982, the Agency issued a Pesticide Registration Standard for
hexazinone. At that time the registered food uses were for the culture of sugarcane and
alfalfa; and the non-food uses were identified as non-cropland, Christmas tree
plantations, and reforestation areas. Formulations of hexazinone products consisted of
a 90% soluble powder, a 0.5% liquid, a 25% liquid, a 10% pellet and a 60% dry
flowable. Three of the registered pesticide products were marketed under the duPont
trademarked name Velpar®.
The Agency's Office of Drinking Water issued a drinking water Health
Advisory for hexazinone in August 1988. A Lifetime Health Advisory (HA) was
determined to be 0.21 mg/L (200 ppb) for an adult consuming 2 liters of water per
day. For a 10 kg child a one- and ten-day health advisory was determined to be 2
mg/L.
A second Registration Standard was issued in September, 1988 (NTISf PB89-
126080). The 1988 Standard summarized available data supporting the registration of
products containing hexazinone as the active ingredient and required additional product
chemistry, residue chemistry, toxicology, ecological effects, and environmental fate
data.
OPP's Carcinogenicity Peer Review Committee classified the carcinogenic
potential of hexazinone as "Group D" on July 27, 1994. They recommended for
purposes of risk characterization that the Reference Dose (RfD) approach should be
used for quantification of human risk. Their determination was made on the basis of a
weight-of-evidence analysis with particular emphasis on carcinogenic potential.
There are presently 20 end-use hexazinone products and one technical
(manufacturing-use) product registered.
Hexazinone may be used as a non-selective herbicide in non-cropland areas, and
it may be used as a selective herbicide for pine release in reforestation practices and in
the culture of alfalfa, blueberries, pineapples, rangeland and pastures, and sugarcane.
It controls a broad spectrum of annual biennial and perennial weeds, including
6
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undesirable woody plants. It is used as a harvesting aid in harvesting wood pulp, used
in the manufacture of paper.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
DESCRIPTION OF CHEMICAL
Hexazinone [3-cyclohexyl-6-(dimethylamino)-1 -methyl-S-triazine-2, 4- (1H, 3H) -
dione] is a triazine-dione herbicide. The molecular structure of hexazinone is
illustrated below:
Other identifying characteristics and codes are:
Empirical Formula: C12H20N402
Molecular Weight: 252.3
CAS Registry No.: 51235-04-2
Shaughnessy No.: 107201
IDENTIFICATION OF ACTIVE INGREDIENT
Technical hexazinone is a white crystalline solid with a melting point of
113.5 C and a bulk density of 0.61 g/mL. Its solubility in water at 25 C is 2.98
g/lOOg. Hexazinone solubilities in methanol, acetone, and hexane are 265,79,
and 0.3 g/100 g, respectively.
CONCLUSIONS
All pertinent product chemistry data requirements for the hexazinone 98%
technical (EPA Reg. No. 352-399) have been satisfied.
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B. Human Health Assessment
1.
Toxicology Assessment
Acute Toxicity
a.
The table below summarizes the results and categories for the
acute toxicity studies.
Guideline
Acute Oral LDTO Rat
Acute Dermal LD5n Rabbit
Acute Inhalation LCstl Rat
Primary Eye Irritation Rabbit
Dermal Irritation Rabbit
Dermal Sensitization Guinea Pig
Results
1200mg/kg
> 5278 mg/kg
3.94mg/L
Severe
Mild
Not a sensitizer
Toxicity
Category
III
IV
IV
I
IV
N/A1
Citation (MRID)
41235004
00104974
41756701
00106003
00106004
41235005
1 N/A = Not Applicable
* Note: Data pertaining to acute eye irritation, dermal irritation, and dermal sensitization are not required to support
the reregistration of the TGAI. These data are presented for informational purposes.
b. Subchronic Toxicity
90-Day Feeding in Rats: Sprague-Dawley rats were fed diets containing
0, 200, 1000 or 5000 ppm of technical grade hexazinone for three
months. The only treatment-related effect was a decrease in body
weight gain of males (7%) and females (15%), when compared with the
controls, in the 5000 ppm group. Other parameters examined
(mortality, toxic signs, food consumption, clinical pathology, organ
weights and histopathology) were not affected. Based on these findings,
the systemic NOEL for both sexes was 1000 ppm (50 mg/kg) and the
systemic LOEL was 5000 ppm (250 mg/kg) (MRID 00104977).
90-Day Feeding in Dogs: Beagle dogs were fed diets containing 0, 200,
1000 or 5000 ppm of technical grade hexazinone for three months. At
the 5000 ppm level, body weight gains and albumin/ globulin values
were decreased, and alkaline phosphatase activity and absolute and
relative liver weights were increased, each in both sexes. There were no
compound-related histological effects. Based on these findings, the
systemic NOEL for both sexes was 1000 ppm (25 mg/kg) and the
systemic LOEL was 5000 ppm (125 mg/kg) (MRID 001114484).
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21-Day Dermal Toxicity in Rabbits: Technical hexazinone was applied
to the intact skin of New Zealand white rabbits, using 5 rabbits/sex/
dose. The levels of hexazinone tested were 0, 50, 400 or 1000
mg/kg/day. The rabbits were exposed for 6 hours/day, for 21 days. The
NOEL for both sexes was ^1000 mg/kg/day (HDT)(MRID 41309005).
c. Chronic toxicity
Chronic Feeding/Carcinogenicity in Rats: Male and female Sprague-
Dawley rats were fed diets containing 0, 200, 1000 or 2500 ppm of
hexazinone for two years. Nothing remarkable was observed in the low-
dose group. In the mid-dose group, females had a slight decrease (about
5%) in body weight gain and food efficiency, compared with the
controls. The following treatment-related effects were reported for the
high-dose group: decreased body weight gains of males and females;
decreased food consumption of males and food efficiency of females;
increased white blood cells and eosinophil in males; alkaline urine in
males and females; decreased absolute and relative weights of liver,
heart and kidneys in males; and increased relative weights of brain,
kidneys and stomach in females. Based on these findings, the systemic
NOEL for both sexes was 200 ppm (10 mg/kg/day) and the systemic
LOEL was 1000 ppm (50 mg/kg/day) (MRID 00108638).
Chronic Feeding in Dogs: Beagle dogs were fed diets containing 0,
200, 1500 or 6000 ppm of hexazinone for 12 months. Nothing
remarkable was observed in the low-dose group, in both sexes. In the
mid-dose group, the following findings were observed in males:
increased serum alkaline phosphatase and globulin, decreased albumin,
increased incidence of hepatocellular vacuolation and thinness (in one
dog). The only findings reported for the mid-dose females were pale
kidneys (in one dog) and an increased incidence of cytoplasmic
inclusions and pigmented Kupffer cells in the liver. In the high-dose
group, the following effects were observed in both sexes: decreased
body weight gain and food consumption; decreased serum albumin,
calcium, cholesterol, glucose and inorganic phosphorus; increased blood
urea nitrogen (BUN), globulin, mean corpuscular volume (MCV) and
mean corpuscular hemoglobin concentration (MCHC); and increased
serum aspartate amino transferase (AST or SCOT), alanine amino
transferase (ALT or SGPT) and alkaline phosphatase activities. Red
blood cells, hematocrit and hemoglobin were decreased only in the
males, total protein was decreased only in the females, whereas
creatinine was increased only in the females. Also, relative liver weight
(liver weight/body weight ratio) was increased in the males (57.1%) and
the females (62.5%). Non-neoplastic liver histopathology was present in
9
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both sexes at the high-dose. Based on the above findings, the systemic
NOEL for both sexes was 200 ppm (5 mg/kg/day) and the systemic
LOEL was 1500 ppm (37.5 mg/kg/day) (MRID 42162301).
d. Carcinogenicity
Chronic Feeding/Carcinogenicity in Rats: Sprague-Dawley rats were
fed diets containing 0, 200, 1000 or 2500 ppm of hexazinone for two
years. Hexazinone was not carcinogenic in this study (MRID
00108638).
Carcinogenicity in Mice: CD-I mice were fed diets containing 0, 200,
2500 or 10000 ppm of hexazinone for two years. The average
consumption of hexazinone in mg/kg/day was 28, 366 or 1635,
respectively, for males and 34, 450 or 1915, respectively, for females.
Nothing remarkable was observed in the low dose-group. In the mid-
dose group, body weight gains were decreased in both sexes and there
was an increased incidence of liver hypertrophy and hepatocellular
adenomas and carcinomas in the males, when the treated mice were
compared with the concurrent controls. Relative to the control values,
the following findings were reported for the high-dose group: decreased
body weight gains in both sexes; increased mean absolute liver weight in
males; increased mean relative weight (liver weight/body weight ratio)
in males and females; increased incidence of hepatocellular hypertrophy
in males and females; increased incidence of hepatic focal necrosis and
hyperplastic nodules in males; increased incidence of hepatocellular
adenomas and adenomas plus carcinomas in both sexes (when compared
with concurrent and historical controls). Based on the above findings,
the systemic NOEL was 200 ppm (28 mg/kg/day for males and 34
mg/kg/day for females) and the systemic LOEL was 2500 ppm (1635
mg/kg/day for males and 1915 mg/kg/day for females). Also,
hexazinone appeared to be carcinogenic in this study (MRID 00079203,
41359301 and 42509301).
Peer Review: The carcinogenic potential of hexazinone was evaluated
by OPP's Carcinogenicity Peer Review Committee (CPRC) on July 27,
1994. The Committee concluded that hexazinone should be classified as
a Group D chemical. It was also recommended that, for the purpose of
Risk Characterization, the Reference Dose (RfD) approach should be
used for quantification of human risk.
The CPRC decision to re-categorize hexazinone as Group D was
based on the registrant's submission of a reevaluation of mouse liver
sections (based on the latest diagnostic criteria for mouse liver
10
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neoplasms). Based on these new data, there was only a statistically
significant increasing trend in combined adenoma/carcinoma in female
CD-I mice. It was noted though, that combined adenoma/carcinoma
hepatocellular tumors in female CD-I mice occur at a low rate (< 5% in
historical controls, and the incidence in these concurrent controls was
only 1-2%) whereas the incidence for combined liver tumors at the HOT
was 9%.
Overall, it was felt that the animal evidence was equivocal (not
entirely negative, but yet not convincing) based on the new readings.
Based on these data, the only statistically significant increase was in the
female mice (by trend test, but not by pairwise comparison with
controls). Additional testing would not provide any clarification,
therefore hexazinone was re-categorized as a Group D; not classifiable
as to human carcinogenicity.
e. Developmental Toxicity
Developmental Toxicity in Rats: Mated Sprague-Dawley rats were
administered single oral daily doses of hexazinone by gavage during
gestation days 7 through 16. The following dose levels were tested: 0,
40, 100, 400 and 900 mg/kg/day. Treatment-related effects, observed
only in dams from the 400 mg/kg/day and 900 mg/kg/day groups,
included alopecia, and stained chin and nose; decreased body weight
gain and food consumption during and after dosing, until the termination
of the study; and increased relative liver weight (liver weight/body
weight ratio). Treatment-related developmental effects, observed only in
the 400 mg/kg/day and 900 mg/kg/day groups, included decreased fetal
body weights; and increased incidence of fetuses with no kidney papilla
and with unossified sternebrae. Maternal and developmental toxic
effects observed in the 900 mg/kg/day group were, in most instances,
statistically significant (p < 0.05) when compared with those observed in
the control group. Maternal and developmental toxic effects observed in
the 400 mg/kg/day group were minimal and only occasionally
statistically significant (p <0.05) when compared with those noted in the
controls. Based on the above findings, maternal NOEL and LOEL were
100 mg/kg/day and 400 mg/kg/day, respectively. The developmental
NOEL and LOEL were also 100 mg/kg/day and 400 mg/kg/day,
respectively (MRID 40397501).
Developmental Toxicity in Rabbits: Pregnant New Zealand white
rabbits were administered single oral daily doses of hexazinone by
gavage during gestation days 6 through 19. The following dose levels
were used: 0, 20, 50 and 125 mg/kg/day. Treatment-related maternal
11
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toxic effects were observed only in the high-dose group and included
increased incidence of depression and discharge from the eyes;
decreased body weight gain; and increased resorptions. Treatment-
related developmental effects were observed also only in the high-dose
group and included decreased fetal body weight gain and delayed
ossification of extremities. Based on these findings, the NOEL and
LOEL for maternal toxicity were 50 mg/kg/day and 125 mg/kg/day,
respectively. The NOEL and LOEL for developmental toxicity were
also 50 mg/kg/day and 125 mg/kg/day, respectively (MRID 00028863).
f. Reproductive Toxicity
2-Generation Reproduction Rat: In the one study available, male and
female Sprague-Dawley rats were administered hexazinone continuously
in the diet for two successive generations at the following dose levels:
0, 200, 2000 or 5000 ppm. Treatment-related effects were observed
only in the mid-dose and high-dose groups and included decreased body
weight gain in PI and Fl females during growth and gestation;
decreased food consumption in Fl females during gestation; decreased
pup weight in Fl, F2a and F2b litters; and decreased pup survival in F2b
litters (only in the high-dose group). Based on these findings, the
systemic NOEL and LOEL were 200 ppm (10 mg/kg/day) and 2000
ppm (100 mg/kg/day), respectively. The NOEL and LOEL for
reproductive toxicity were also 200 ppm and 2000 ppm, respectively
(MRID 42066501).
g. Mutagenicity
Hexazinone was found to be positive for mutagenicity in one
chromosome aberration assay (in vitro cytogenetic assay), but was
negative in the remaining studies.
Gene Mutation Assay in Ames Test: Hexazinone was tested with
metabolic activation (rat liver microsomal fraction commonly known as
S-9 fraction, plus cofactors) at concentrations ranging from 400 to 2000
ug/plate and without metabolic activation at concentrations ranging from
200 to 1000 ug/plate. The strains of Salmonella typhimurium used were
TA1535, TA1537, TA1538, TA98 and TA100. No increases in reverse
mutations were observed at any concentration. Positive results were
obtained with standard reference mutagens (positive controls) (MRID
00098982).
Gene Mutation Assay in Mammalian Cells: Hexazinone was tested in
the Chinese hamster ovary (CHO) cells/hypoxanthine - guanine -
12
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phosphoribosyl transferase (HGPRT) assay, with and without metabolic
activation. No mutagenic response was observed up to cytotoxic doses
(13.9 mM without metabolic activation and 9.9 mM with metabolic
activation (MRID 00076956).
Structural Chromosome Aberration Assay; In vitro Cytogenetic Assay:
The mutagenic potential of hexazinone was evaluated in vitro, using
Chinese hamster ovary (CHO) cell system with and without metabolic
activation. The concentrations of hexazinone tested (which were not
toxic to cells) ranged from 1.58 to 19.82 mM, without metabolic
activation and from 0.32 to 15.85 mM, with metabolic activation.
Hexazinone was mutagenic in this study. Relative to the control
(solvent) values, there was a significant (p< 0.01) increase in structural
chromosomal aberrations/cell at hexazinone concentrations of 15.85 mM
(and above), without and with metabolic activation (MRID 00130709).
Structural Chromosome Aberration Assay; In vivo Cytogenetic Assay:
Single doses of hexazinone (0, 100, 300 or 1000 mg/kg) were
administered by oral gavage to mature male and female Sprague-Dawley
rats, and their bone marrow cells were examined for clastogenic
(chromosome-damaging) effect. Relative to the control (solvent) values,
no significant increase of chromosomal aberrations was observed in any
of the treated groups. However, a highly significant number of
chromosomal aberrations was observed in the bone marrow cells of rats
treated with cyclophosphamide, a standard reference mutagen (MRID
00131355).
Other Genotoxic Effects Assay; Unscheduled DNA Synthesis in Rat
Hepatocytes: Primary hepatocytes, obtained from the livers of 8-week
old male Sprague-Dawley rats, were exposed to eight hexazinone
concentrations ranging from 1x10 5 mM to 30 mM. Hexazinone did not
elicit unscheduled DNA synthesis at any level of concentrations tested.
Positive results were obtained with 7,12-Dimethylbenz(a) anthracene -
DMBA, a standard reference compound (positive control) (MRID
00130708).
h. Metabolism
General Metabolism: In the one study available, three groups of male
and female Sprague Dawley rats were treated as follows: (1) Group A
received a single intragastric low dose of 14C-hexazinone (14 mg/kg)
without preconditioning (treatment with non-radioactive hexazinone); (2)
Group B received a single intragastric dose of 14C-hexazinone (14
mg/kg) after three weeks of preconditioning with 100 ppm of non-
13
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radioactive hexazinone in the diet; and (3) Group C received a single
intragastric high-dose of 14C-hexazinone (1000 mg/kg) without
preconditioning.
Hexazinone was rapidly metabolized by hydroxylation and
demethylation, and eliminated by the rats in urine and feces during the 3
to 6-day testing periods. About 77% and 20% (of the administered
dose) of 14C-hexazinone was excreted in urine and feces, respectively.
Practically all radioactivity was recovered in the first 24 hours after
treatment. Very low levels of radioactivity (about 0.2% of the
administered dose) were detected in the G.I. tract, hide, organs (heart,
lungs, liver, spleen, kidneys, brain, and testes or ovaries), muscle, fat
and blood. Eight metabolites were identified in urine and feces. The
major metabolites in both urine and feces were (1) 3-(4-hydroxy-
cyclohexyl)-6-(dimethylamino)-l-methyl-1,3,5-triazine-2,4(1 H,3H)-
dione and (2) 3-(4-hydroxycyclohexyl)-6-(methylamino)-l-methyl-1,3,5-
triazine-2,4(lH,3H)-dione (MRID 00247874).
i. Other Toxic Endpoints
Dermal Penetration/Absorption: This study is not required. Based upon
a comparison of the results of a Developmental Toxicology Study in
rabbits (MRID 00028863, Developmental NOEL = 50 mg/kg/day) and
a 21-Day Dermal Toxicity Study in Rabbits (MRID 41309005, NOEL
= 1000 mg/kg/day), little or no absorption of hexazinone through the
skin is anticipated.
Domestic Animal Safety: Data are not required for the use patterns of
hexazinone (a selective herbicide used to control grasses, broadleaf
weeds, and woody plants).
j. Reference Dose (RfD)
OPP's RfD Committee recommended that an RfD should be
established based upon a NOEL of 5 mg/kg/day for changes in clinical
chemistry and histopathological parameters observed at 37.57
mg/kg/day in males and females in the one-year feeding study in dogs
(MRID 42162301). An Uncertainty Factor (UF) of 100 was used to
account for the inter-species extrapolation and intra-species variance. On
this basis, the RFD was calculated to be 0.05 mg/kg/day. Based on
available information, there does not appear to be any reference to an
evaluation of hexazinone by JMPR/International Programme on
Chemical Safety (IPCS).
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2. Exposure Assessment
a. Dietary Exposure
Confined Rotational Crops: A study was submitted, reviewed, and
found supplemental; additional data were required on onions, and new
studies were required on sorghum (small grain) and a leafy vegetable
crop.
The supplemental onion data have been submitted, reviewed, and
the root crop portion of the confined rotational crop requirement is
considered satisfied. A rotational restriction of 12 months for root crops
is required and no tolerances are needed for root crops rotated into fields
12 months after treatment with hexazinone. If the registrant desires
plant back intervals of less than 12 months, appropriate tolerances for
root crops may need to be established. Depending on the results of the
confined rotational crop studies in sorghum and leafy vegetables,
additional data may be needed to fulfill §165-2, Field Rotational Crop
Studies. The sorghum and leafy vegetable data are due to the Agency by
5/31/95 (MRID 41008401, 42824001).
Plant Metabolism: The initial Hexazinone Registration Standard dated
2/82 concluded that the qualitative nature of the residue in plants is
adequately understood. Studies conducted on sugarcane, alfalfa, and
pineapple indicate that root uptake is the principal mechanism for the
absorption of hexazinone by plants from soils. Hexazinone is
translocated through the xylem to the foliage where it blocks the
photosynthetic process. The data indicate that hexazinone is metabolized
by hydroxylation to metabolite A which is then metabolized to
metabolite C by demethylation and to metabolite E after oxidation.
Residues of concern are hexazinone and its metabolites A [3-(4-
hydroxycyclohexyl) -6- (dimethylamino) -1 -methyl-1,3,5-triazine-2,4-
(lH,3H)-dione)], B [3-cyclohexyl-6-(methylamino)-l-methyl-1,3,5-
triazine-2,4-(lH,3H)-dione], C [3-(4-hydroxycyclohexyl)-6-
(methylamino)-l-methyl-l,3,5-triazine-2,4-(lH,3H)-dione], D [3-
cyclohexyl-l-methyl-l,3,5-triazine-2,4,6-(lH,3H,5H)-trione], and E [3-
(4-hydroxycyclohexyl)-l-methyl-l,3,5-triazine-2,4,6-(lH,3H,5H)-
trione] (MRID 00078047, 00104846, 00126127).
Animal Metabolism: The nature of the residue of hexazinone in
livestock commodities is adequately understood. Metabolites of concern
are those containing the triazine ring. Hexazinone and metabolites A, B,
C, D, E, and F [3-cyclohexyl-6-amino-l-methyl-l,3,5-triazine-2,4-
15
-------
(lH,3H)-dione] will be regulated. Recovery data are needed for
metabolite F.
In poultry, the maximum residue expected in poultry tissues
would be 0.005 ppm, an order of magnitude below the limit of detection
for hexazinone metabolites. The Agency concludes that tolerances for
hexazinone in poultry commodities are not required and the existing
tolerances for these commodities should be revoked. Additional raw data
are required to support the goat metabolism study (MRID 41524801,
42187901, 42219301, 42248901, 42690601, 43074201).
Residue Analytical Methods - Plants: An adequate method for purposes
of data collection and enforcement of tolerances for hexazinone residues
and metabolites A, B, C, D, and E in or on plant commodities is
available. The GLC/nitrogen-detection method for determining
trifluoroacetic anhydride-derivatized residues of hexazinone is described
in PAM, Vol. II, as Method I. The combined limit of quantitation for
hexazinone residues by the method in PAM, Vol. II, is 0.55 ppm
(41572101, 41572102, 41572103, 41572104, 41572105, 41572106,
42987201, 43025401).
Residue Analytical Methods - Animals: There are no existing tolerance
enforcement methods available for ruminant commodities in PAM,
Vol. II. The registrant has proposed to develop methods to detect
marker compounds in ruminants using six markers. Data collection and
tolerance enforcement methodology for ruminant commodities must be
capable of determining hexazinone residues of concern. Because the
chemical structures of metabolite F and B are similar, it may also be
possible to adapt the method for determining plant metabolites to
determine ruminant metabolites.
Storage Stability: The available storage stability data indicate that
residues of hexazinone and its metabolites A, B, C, D, and E are stable
under frozen (-10 to -20 °C) storage conditions in blueberries for up to
13 months, in pineapple fruit for up to 8 months, in pineapple juice for
up to 6 months, in sugarcane for up to 12 months, and in sugarcane
processed commodities for up to 6 months. Additional data are required
on storage stability of metabolites A, C, and E in pineapple bran.
Hexazinone and metabolites A, B, D, and E are stable under frozen
storage conditions in grass for up to 24 months; additional data are
required on storage stability of metabolite C in grass matrices for 34
months. A 2-year interim report is due by 1/31/95 and the final study is
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due by 1/31/96. The requirement for storage stability data on alfalfa
remains outstanding; these data are due to the Agency by 4/30/96
(MRID 42867501, 42535601, 42492101, 42423001, 42276001,
42867501).
Magnitude of the Residue in Meat, Milk, Poultry, and Eggs: A cattle
feeding study is still required. The most recent metabolism studies
indicated a very significant transfer of residues to meat and milk. The
existing tolerances for meat/meat byproducts and milk do not reflect the
current metabolic profile and the current tolerance levels cannot be
reassessed until the cattle feeding study is completed. The existing
tolerances are protective until the new data are evaluated. This study is
due to the Agency by 5/30/95.
Poultry feeding studies are not required because the maximum
residue expected in poultry tissues would be 0.005 ppm, an order of
magnitude below the limit of detection for hexazinone metabolites.
Magnitude of the Residue in Plants: Data have been submitted on
magnitude of the residue in plants for all registered crops. Additional
information or data are required on alfalfa seed and seed screenings,
grass hay and processed commodities of pineapple. Certain label
changes were required for alfalfa, blueberries, pineapple, pineapple
forage, and sugarcane. These uses are only on duPont labels and all
have been or are being amended. Data show that hexazinone
concentrates in certain processed fractions of alfalfa, pineapple, and
sugarcane. The Agency has determined that establishing food and feed
additive tolerances for these commodities is appropriate and consistent
with the Delaney Clause of Section 409 of the Federal Food, Drug, and
Cosmetic Act (FFDCA) (MRID 43074401, 43074402, 41964101,
41964102, 41898301, 42418001, 42419101, 42867501, 42492101,
42535601, 42322701, 42417901, 42276001, 43074401, 43074402).
b. Occupational and Residential Exposure
Postapplication/reentry data and handler (mixer/loader/
applicator) data are required when both toxicity and exposure criteria are
met. Hexazinone is a selective herbicide used to control undesirable
herbaceous plants in forage grasses, sugarcane, and alfalfa. Hexazinone
is also used to control herbaceous and woody plants in Christmas tree
plantations and non-crop areas, and to control undesirable plant species
in forestry site preparation and conifer release programs.
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Agricultural crops are treated using groundboom equipment,
aircraft, and wiper/wick applicators. Label directions also include
directions for impregnating dry bulk fertilizer with hexazinone.
Undesirable small trees growing in rangeland and pasture sites are
treated using exact delivery handgun applicators.
Non-crop areas such as highway right-of-ways, petroleum tank
farms, ditch banks, industrial plant sites, and railroads are treated using
handgun or fixed boom sprayers for liquid formulations. A pelleted
formulation provides for treating undesirable species by placing one or
two pellets next to the tree or shrub to be controlled.
Forestry applications include the use of aircraft, groundboom
equipment, handguns, and the use of back-pack equipment modified for
granular applications. Undesirable trees may also be treated by injection
using hypo-hatchet type equipment primarily along ditch banks or in
areas with high water tables.
Hexazinone is not intended for use in residential areas.
Uses Within the Scope of the Worker Protection Standard (WPS)
The 1992 Worker Protection Standard for Agricultural Pesticides
(WPS) established certain worker-protection requirements (personal
protective equipment, restricted entry intervals, etc.) to be specified on
the label of all products that contain uses within the scope of the WPS.
Uses within the scope of the WPS include all commercial (non-
homeowner) and research uses on farms, forests, nurseries, and
greenhouses to produce agricultural plants (including food, feed, and
fiber plants, trees, turf grass, flowers, shrubs, ornamentals, and
seedlings). Uses within scope include not only uses on plants, but also
uses on the soil or planting medium the plants are (or will be) grown in.
At this time some of the registered uses of hexazinone are within
the scope of the WPS and some uses are outside the scope of the WPS.
Those that are outside the scope of the WPS include use:
• on pastures or rangelands;
• on plants grown for other than commercial or research purposes;
• on plants that are in ornamental gardens, parks, golf courses, and
public or private lawns and grounds and that are intended only
for decorative or environmental benefit. (However, pesticides
used on sod farms ARE covered by the WPS);
18
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• in a manner not directly related to the production of agricultural
plants, including, for example, control of vegetation along
rights-of-way and in other non-crop areas.
Toxicity Information
Acute Toxicity: The toxicological data base for hexazinone is adequate
and will support reregistration. Acute toxicity studies indicate that
technical hexazinone is category III for acute oral toxicity, category IV
for acute dermal toxicity, category IV for acute inhalation toxicity,
category IV for skin irritation potential, and category I for eye irritation
potential. It is not classified as a skin sensitizer.
Other Adverse Effects: For occupational/residential exposure, there
are no toxicological end-points of concern for hexazinone. The Agency
notes that it is classified as Group D for carcinogenic potential with a
reference dose of 0.05 mg/kg/day and is poorly absorbed through the
skin with little or no absorption anticipated. Since both the handler and
post-application exposure concerns are predominantly related to skin
contact, the toxicity criteria for either occupational or residential
exposure assessments are not triggered.
3. Risk Assessment
a. Dietary
Toxicological Endpoint: The DRES chronic analysis used a Reference
Dose (RfD) of 0.05 mg/kg body weight/day, based on a No Observable
Effect Level (NOEL) of 5.0 mg/kg bwt/day and an uncertainty factor of
100. The NOEL was based on a one year feeding study in dogs (MRID
42162301) which demonstrated liver effects in both males and females at
38 mg/kg bwt/day (OPP RfD Peer Review Committee on February 11,
1993). Hexazinone was classified as a Group D chemical by the OPP
Carcinogenicity Peer Review Committee on July 27, 1994.
Residue Information: Food uses in this analysis include all published
tolerances listed in the Tolerance Index System (TIS) and 40 CFR
§180.396. All published tolerances are being supported in the
reregistration of hexazinone. New values for anticipated residues (ARs)
have been prepared by the Chemistry Branch-Reregistration Support
(CBRS). Tolerances exist for animal feed commodities which result in
secondary residues in meat of cattle, goats, horse, poultry, hogs and
sheep as well as milk and eggs (the database from which the ARs were
calculated is incomplete and a reassessment of the ARs may be necessary
19
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in the future). The anticipated residues for blueberries, milk, and
sugarcane (DRES commodities cane sugar and sugar-molasses) are
higher than the tolerance residues in this analysis. According to the
Agency these anticipated residues (except milk) were determined as one-
half the combined limit of quantitation of the residues regulated.
Results: The DRES chronic analysis used tolerance level residues and
100 percent crop treated information to estimate the Theoretical
Maximum Residue Contribution (TMRC) for the overall U.S.
population and 22 DRES subgroups. Anticipated residues were used for
further refinement to calculate the Anticipated Residue Contribution
(ARC) for those same population groups. The ARC for the overall U.S.
population from all tolerances is 3.5 x 103 mg/kg bwt/day or 7% of the
RfD. The subgroup most highly exposed, non-nursing infants (< 1 yr)
has an ARC from all uses of 2.0 x 102 mg/kg bwt/day, representing
40% of the RfD. The children (1-6 yrs) subgroup has an ARC from all
tolerances of 1.0 x 102 mg/kg bwt/day, or 20% of the RfD. There are
no pending or new tolerances being proposed for the reregistration of
hexazinone. Anticipated residues were used for all commodities.
However, a source of overestimation exists in that 100 percent crop
treated was assumed for all commodities. The dietary risk from
hexazinone through the published tolerances appears to be minimal.
However, residue chemistry data gaps for hexazinone remain and data
submitted in the future could alter estimated dietary exposure to
hexazinone residues.
b. Occupational and Residential
Agency review of the complete toxicological data submitted to
support reregistration indicates that for hexazinone the toxicology
criteria for a post-application exposure assessment are not met.
Therefore, no occupational exposure assessment is required.
Hexazinone is not used in residential areas.
No changes in the personal protective equipment required by the
WPS are being imposed in this document. However, the REI is being
changed from 24 to 48 hours because hexazinone is in toxicity category I
for primary eye irritation.
20
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4. Data Requirements
The following data required for the reregistration of hexazinone are
considered confirmatory:
Residue Chemistry:
• 171-4d Residue Analytical Method Ruminant
• 171-4e Storage Stability (Alfalfa, Metabolite C for Grass)
• 171-4] Magnitude of the Residue in Meat/Milk
• 171-4k Magnitude of the Residue in Grass Hay and Alfalfa Seed
Screenings
C. Environmental Assessment
1. Environmental Fate
a. Environmental Chemistry, Fate and Transport Data
Hydrolysis: Hexazinone will not hydrolyze under normal environmental
conditions. Hexazinone was reported to be stable in pH 5,7, and 9
buffer solutions when incubated in the dark at 25 C. Unchanged
hexazinone comprised from 99 - 100% of total radioactivity recovered in
all samples (MRIDs 00064620, 41587301).
Photodegradation in Water: No photodegradation half-life in water for
hexazinone was reported. Hexazinone did not appear to degrade
significantly in buffered pH 7 solution when exposed to an artificial light
source. Hexazinone accounted for 86.6 to 96.0% of applied
radioactivity over the 30 day testing period. Dark controls were
reported to have similar results with hexazinone accounting for 91.3 to
97.2% of applied radioactivity over the 30-day testing period.
Analytical methods were not sufficient to characterize the remaining 2.6
to 9.9% of applied radioactivity (MRID 41300801).
Photodegradation on soil: Hexazinone had a reported half-life of 82
days, which is equivalent to a half-life of approximately 228 days at
latitude 30° to 50° N with 12 hours of natural sunlight, when applied to
sandy loam soil and exposed to an intermittent (xenon arc lamp) light
source for 30 days. However, hexazinone did not appear to degrade
significantly in dark control samples. At least 6 degradates were
discernible, with only one product, 3-cyclohexyl-6-(methylamino)-l-
methyl-l,3,5-triazine-2,4(lH,3H)-dione, accounting for at least 10%
applied radioactivity. Of the degradation products, 14C02 accounted for
21
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only 0.2% of the total applied radioactivity. The remaining minor
degradation products, none of which comprised more than 2.6% of the
total applied radioactivity, did not appear to correspond to any of the
other reference compounds (MRID 41300802).
Aerobic soil metabolism: Hexazinone had reported half-lives of 216
days and 1440 days when applied to non-sterile and sterile sandy loam
soil and exposed to aerobic conditions in the dark at 25°C, respectively.
The non-sterile and sterile soil data indicated that degradation was
mainly a result of microbiological activity. There were 4 metabolites
formed in non-sterile soil. The major degradation products were 3-
hydr oxy-cyclohexyl- 6- (dimethylamino) -1 -methyl-1,3,5 -triazine- 2, 4 (1H, -
3H)-dione, accounting for at least 18.7% (2.24 ppm) of applied radio-
activity after 365 days posttreatment and 3-(ketocyclohexyl)-6-
(dimethylamino)-1 -methyl-1,3,5-triazine-2,4 (1H,3H)-dione, accounting
for at least 10.9% (1.31 ppm) of applied radioactivity after 365 days
posttreatment. Two minor metabolites, Metabolite B and Metabolite D,
reached a maximum concentration of 2.3% (0.28 ppm) and 4.8% (0.58
ppm), respectively, of the applied radioactivity (MRID 41807401,
42635001).
Anaerobic aquatic metabolism: Hexazinone had reported half-lives of
230 days and > 1500 days when applied to non-sterile and sterile
sediment pond water, respectively, and exposed to anaerobic conditions
in the dark at 25°C. The non-sterile and sterile soil data indicated that
degradation was mainly a result of microbiological activity. There were
4 metabolites formed in non-sterile soil. The major degradation
products were 3-hydroxyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-tri-
azine-2,4(lH,3H)-dione, accounting for approximately 5.5% (0.66 ppm)
of applied radioactivity after 365 days posttreatment and 3-
(ketocyclohexyl) -6- (dimethylamino) -1 -methyl-1,3,5-triazine-
2,4(lH,3H)-dione, accounting for approximately 25.0% (3.00 ppm) of
applied radioactivity after 365 days posttreatment. Another metabolite,
3-cyclohexyl-l-methyl-l,3,5-triazine-2,4,6-(lH,3H,5H)-trione,
accounted for at least 24.0% (2.88 ppm) of the applied radioactivity
(MRID 41807402, 42657301).
Aerobic aquatic metabolism: Hexazinone had a reported half-life of > 2
months under both sterile and non-sterile conditions incubated at 25°C.
Three major metabolites and one minor metabolite were identified. The
major metabolites [3- (4-ketocyclohexyl)-6- (dimethylamino)-1 -methyl-
l,3,5-triazine-2,4(lH,3H)-dione; 3-(2-hydroxycyclohexyl)-6-(dimethyl-
amino-1-methyl-1,3,5-triazine-2,4(1 H,3H)-dione; 3-(cyclohexyl-6-
(methylamino)-l-methyl-1,3,5- triazine-2,4(lH,3H)-dione] were present
22
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each at concentrations less than 7% of the applied radioactivity. One
minor metabolite, 3-(cyclohexyl-l-methyl-l,3,5-triazine-2,4,6-
(lH,3H,5H)-trione, reached a maximum concentration of 1.3% of
applied radioactivity. The reported data indicated there were no
significant differences in the sterile and non-sterile data. This lack of
significant differences could be related to the duration of the test period
(56 days). The aerobic soil metabolism study which was carried out for
1 year had reported half-lives of 216 days and 1440 days when applied
to non-sterile and sterile soils, respectively (MRID 41811801).
Leaching/Adsorption/Desorption: Based on batch equilibrium,
radioactive hexazinone weakly adsorbs on Hanford sandy loam and Cecil
sandy loam soils (Ka = 0.24 - 0.45). However, it appeared to weakly
adsorb on Flanagan silt loam soil (Ka = 1.03) and strongly adsorb on
Madera loam soil (Ka = 10.8). Adsorbed radioactivity was relatively
easily desorbed from these soils (1/nD = 0.36 to 0.72). Furthermore,
based on supplemental soil thin layer chromatography data, the soil
mobility of hexazinone (Rf = 0.05 to 0.60) and its major soil degradates
(Rf = 0.02 to 0.73), ranged from immobile (EPA Class 1) to mobile
(EPA Class 4). In general, the relative mobility of hexazinone
degradates appeared to be similar or identical to that of the parent
material. The batch equilibrium study is scientifically valid and is
acceptable to partially fulfill the data requirement. Aged mobility data
(preferably batch equilibrium) for hexazinone metabolites are required.
These data are due by 4/1/95 (MRIDs 00646262, 41528101).
Field dissipation: Hexazinone had dissipation half-lives of 123 to 154
days in bare ground silt loam soil in Newark, DE and bare ground silty
clay loam soil in Greenville, MS. Metabolites A, A-l, B, C, and 1
were identified in soils at maximum concentrations of 0.04, 0.21, 0.31,
1.23, and 0.71 ppm, respectively. The reported data indicate that
hexazinone did not move below the top 30 cm of soil (> 95% confined
to the upper 30 cm of soil) at the Newark, DE site. However,
hexazinone did move to a depth of 60-75 cm at the Greenville, MS site.
In addition, hexazinone metabolites (listed above) leached to a depth of
75 cm in soil during the testing period.
Two of the bare soil field dissipation studies (MRID 42377901)
are scientifically valid and provide acceptable data to fulfill the field
dissipation data requirement. However, the bare soil field dissipation
study done in California (MRID 42379201) is of uncertain value.
Although the study was conducted on bare soil, < 30% recovery of the
theoretical application rate was detected in the Day 0 posttreatment
sample. This recovery is inadequate to confirm the validity of the study.
23
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However, no further field dissipation data for hexazinone are needed at
this time (MRID 42377901).
Forestry dissipation: Hexazinone dissipated with reported half-lives of
26 to 59 days and 19 to 36 days in plants for the ULW end-product site
and the Velpar L end-product site, respectively. Similar half-lives of 55
to 77 days were reported for litter and soil (except litter covered soil)
for the two sites. For litter covered soil, a half-life of 265 days was
reported by the author. By day 365 posttreatment, hexazinone was
discernible only in sediment samples. In addition, metabolites A, B, C,
D, E, G, and H were discernible in various matrices (soil, water, litter
and/or vegetation) samples. However, metabolite G was not confirmed
by mass spectrometry. Hexazinone moved off-site through leaching and
runoff. Hexazinone (0.01 to 0.04 ppm) was observed in soil at depths
> 30 cm. In addition, hexazinone was detected (80 to 140 ppb) in
runoff water up to 6 months post-application (MRIDs 00072664,
42336401).
b. Environmental Fate Assessment
Based on laboratory data, hexazinone appears to be persistent and
mobile in soil and aquatic environments. Field and forestry dissipation
data confirm this. In addition, hexazinone was reported in runoff water
(80 to 140 ppb) up to 6 months posttreatment in the forestry dissipation
study. Therefore, field and laboratory data are consistent and indicate
that hexazinone may be of concern for groundwater and surface water
contamination. Groundwater contamination has been reported in Hawaii
(0.06-0.72 ppb), Florida (0.12-2.90 ppb), Maine (0.2-29 ppb), and
North Carolina (0.74-34 ppb). Hexazinone can contaminate surface
waters by spray drift at application and probably for several months
post-application via runoff (primarily by dissolution in runoff water). It
may be persistent in some receiving surface waters (particularly those
with low microbiological activities and long hydrological resident
times). Based upon its low soil/water partitioning, it will probably exist
primarily dissolved in the water column. Based on the octanol/water
coefficient (15), hexazinone is not expected to accumulate in fish.
However, supplemental confined rotational crop data indicated that
hexazinone does accumulate in crops grown on treated soil. Even
though additional data are needed on the mobility of degradates, the data
reviewed suggests that the degradates are also persistent and mobile.
24
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2. Ecological Effects
a. Ecological Effects Data
(1) Terrestrial Data
Acute Avian Oral Toxicity: Study results indicate that
hexazinone is practically non-toxic to birds on an acute oral
basis. Using 98% pure test material resulted in an LD50 of 2251
mg/kg (MRID 00073988).
Avian Subacute Dietary Toxicity: The results summarized in the
table below indicate that on a subacute dietary basis, hexazinone
is practically non-toxic to birds (MRIDs 00104981, 00072663,
00107878).
Test Species
Mallard
Bobwhite
Bobwhite
Test Material
97.5%
99%
97.5%
LC5n
>5,000 ppm
> 5, 000 ppm1
>5,000 ppm
Citation (MRID)
00104981
00072663
00107878
1 An LC50 of 11,346 ppm was calculated based on 3 out of 10 mortalities in the highest
dose tested, which was 5000 ppm.
Avian Reproduction: Two avian reproduction studies conducted
show that the No Observed Effect Concentration (NOEC) for the
bobwhite quail is < 100 and for the mallard duck is > 1000 ppm.
The NOEC for the bobwhite quail was based on effects to the 14
day survivors weight at 100 ppm. No effects were seen at the
other doses. The mallard duck study showed no statistically
significant effects. A weight reduction trend was observed in the
male body weight change (MRIDs 41764901, 41764902,
41938001).
(2) Aquatic Data
Acute Freshwater Fish Toxicity - TGAI: The results of studies
conducted show that technical hexazinone is practically nontoxic
to freshwater fish in acute exposures. The table below
summarizes the results of these studies (MRIDs 00104980,
00076959).
25
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Test Species
Rainbow Trout
Bluegill Sunfish
Fathead Minnow
Bluegill Sunfish
Test Material
97.5%
97.5%
97.5%
95%
T r
Lv^50
>320 ppm
>370 ppm
274 ppm
505 ppm
Citation (MRID)
00104980
00104980
00104980
00076959
Acute Freshwater Fish - TEP: The results of the studies
summarized in the table below show that the 25% hexazinone
product is practically non-toxic to freshwater fish in acute
exposures.
Test Species
Bluegill Sunfish
Rainbow Trout
Test Material
25%
25%
LC5n
> 1000 ppm
> 585.6 ppm
Citation (MRID)
41235001
41235002
Early Life Stage Fish - TGAI: The results of a study done with
the fathead minnow with 98% pure hexazinone resulted in a
Maximum Allowable Toxicant Concentration (MATC) of 24.6
ppm. The MATC is the geometric mean of the No Observed
Effect Level (NOEL), which was 17 mg/1 and the Lowest
Observed Effect Level (LOEL), which was 35.5 mg/1. Fish
length was the parameter affected in the study (MRID
41406001).
Acute Aquatic Invertebrate Toxicity - TGAI: A study on
Daphnia magna with 95% pure hexazinone resulted in an EC50 of
151.6 ppm. This demonstrates that hexazinone is practically
nontoxic to freshwater invertebrates in acute exposures (MRID
00116269).
Acute Aquatic Invertebrate Toxicity - TEP: A study on Daphnia
magna with 25% pure hexazinone resulted in an EC50 of 339.9
ppm. This study shows that hexazinone typical end-use product
is practically nontoxic to freshwater invertebrates in acute
exposures (MRID 41235003).
Life Cycle Aquatic Invertebrate - TGAI: The table below
summarizes the results of two studies conducted.
26
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Test Species
Daphnia magna
Daphnia magna
Test Material
89.3%
>98%
MATC
20-50 ppm
48.5 ppm
Citation (MRID)
00078041
41406002
In the first study the affected parameter was reproduction.
This study was classified as supplemental because a description of
the dilution water was not sufficient, and no description of the
dilution preparation was provided. The second study was also
classified as supplemental because data on the dry weight of the
first generation daphnids was not provided. The affected
parameter was daphnid survival. The MATC is the geometric
mean between the NOEL (29 mg/1) and the LOEL (81 mg/1).
The combination of both studies fulfills the guideline
requirements for an aquatic invertebrate reproductive test
(MRIDs 00078041, 41406002).
Estuarine and Marine Toxicity - TGAI: The table below
summarizes the results of three separate studies.
Test Species
Eastern oyster
Grass shrimp
Fiddler crab1
Test Material
95%
95%
95%
Results
48 hour ECW > 320 ppm
96 hour LCW = 78 ppm
96 hour LCW > 1000 ppm
Citation (MRID)
00047164
00047164
00047164
'The test organism was not a recommended species.
These studies demonstrate that hexazinone is practically
nontoxic to mollusks and slightly toxic to crustaceans. The
estuarine/marine fish study was waived based on the low toxicity
of hexazinone to freshwater fish (MRID 00047164).
(3) Non-Target Insects Data
Honey Bee Acute Contact: A study conducted with 98% pure
hexazinone on Apis mellifera resulted in an LD50 of > 100
//g/bee. The results show that hexazinone is relatively nontoxic
to honey bees (MRID 41216502).
27
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(4) Non-Target Plant Data
The acceptable phytotoxicity data on hexazinone are
summarized below. The first three studies are for terrestrial
plants and the remaining studies are for aquatic plants.
Test/Species
Seed Germination1
Seedling Emergence2
Vegetative Vigor3
Navicula pelliculosa
Lemna gibba
Anabaena flos-aquae
Selenastrum
capricornutum
Skeletonema costatum
%ai
100
100
100
100
100
100
100
100
Results
EC25 > 12.01bs
ai/acre
See Table 1
See Table 2
EC50 =
12ppb
EC50 =
37.4 ppb
EC50 =
0.21 ppm
EC50 =
7.0 ppb
EC50 =
12 ppb
MRID#
43162501
43162501
43162501
43302701
43225101
43302701
41287001
43225102
Study is classified as core except for cucumber which is invalid. A new study is not
required.
Study is core for all species except for cucumber (invalid) and onion and pea
(supplemental). A new study is required for cucumber and additional information is
required for onion and pea.
The study is core for all species except for cucumber. A new study for cucumber is
required.
Table 1 . Results of the Seedling Emergence Test
Species
Onion1
Corn
Wheat
Sorghum
Sugar Beet
Soybean
Pea1
Parameter
Visual Injury
Weight
Weight
Weight
Weight
Weight
Visual Injury
EC25
(Ibs ai/a)
0.019
0.029
0.019
0.010
0.055
__
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Table 1 . Results of the Seedling Emergence Test
Species
Tomato
Rape
Cucumber2
Parameter
Weight
Weight
-
EC25
(Ibs ai/a)
0.0064
0.013
-
1 The EC 2 5 for these two species cannot be determined because the raw data were not
in a format to allow for a statistical test.
2 The results for cucumber are invalid because seeds were treated with pesticides other
than hexazinone.
Table 2. Results of the Vegetative Vigor Study
Species
Onion
Corn
Wheat
Sorghum
Sugar Beet
Soybean
Pea
Tomato
Rape
Cucumber1
Parameter
Shoot Weight
Total Weight
Total Weight
Total Weight
Total Weight
Total Weight
Shoot Weight
Shoot Weight
Weight
-
EC25
(Ib ai/a)
0.046
0.071
0.020
0.025
0.012
0.025
0.012
0.013
0.011
-
1 The results for the cucumber are invalid because seeds were treated with pesticides
other than hexazinone.
The guideline requirements for terrestrial studies are
satisfied for all species except cucumber, onion and pea. New
seedling emergence and vegetative vigor studies with cucumber
are required. The guideline requirements for aquatic plant
growth are satisfied.
b. Ecological Effects Risk Assessment
This section consists of numerous risk assessments each covering
a different combination of endpoint and exposure scenarios. Each risk
29
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assessment includes a risk quotient which combines the toxicity and
exposure information. For each risk quotient there is an established
value above which the risk is considered to be at a high level of concern
(LOG). In addition to these high risk values, restricted use is considered
when the risk quotient exceeds 0.1 for acute aquatic risk or 0.2 for acute
avian risk. The generic risk quotients and their respective LOC's for
each risk assessment are provided in the following table. Note that the
same risk quotients are used for non-endangered and endangered species,
but the acute LOG is lower for endangered species.
Established Levels of Concern (LOCs)
Endpoint/Scenario
Mammalian Acute
Mammalian Chronic
Avian Acute
Avian Chronic
Aquatic Acute
Aquatic Chronic
Risk Quotient
EEC/LC™
EEC/LEL
EEC/LC,,,
EEC/LEL
EEC/LC™
EEC/LEL
Non- Endangered
LOG
0.5
1.0
0.5
1.0
0.5
1.0
Endangered LOC
0.1
1.0
0.1
1.0
0.05
1.0
Risk to Terrestrial Animals
Hexazinone is registered for numerous outdoor uses, including
agricultural crops such as alfalfa and sugarcane, and nonagricultural uses
including forests and ditch banks. Exposure to nontarget organisms can
result from direct applications, spray drift from treated areas, and runoff
from treated areas. Such exposures would be chronic as well as acute.
Avian Acute Oral and Subacute Dietary Effects
Granular Formulations: The maximum application rate for a granular
formulation is 12 Ibs ai/acre. A broadcast application with no
incorporation, which is the application scenario resulting in the greatest
exposure, results in a risk quotient of 0.3 as shown in the calculation
below.
30
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Calculation of LD50/ft2 (Using Quail LD50 = 2251 mg/kg)
[For Broadcast Application (No Incorporation)]
mg/ft2 = application rate (Ibs ai/acre) X 453,590 mg/lb •*• 43,560
fWacre
= [12 Ibs ai/acre X 453,590 mg/lb] •*• 43,560 ftVacre
= 124.96 mg/ft2
LD50/ft2 = mg/ft2 •*• [(LD50) X (bird weight in kg)]
= 124.96 mg/ft2 + [(2251 mg/kg) X (0.178 kg)]
= 0.3 LD50/ft2
The LOG for endangered species, which is 0.1, is triggered at
this application rate. No other LOCs are exceeded for the granular
formulation.
Non-Granular Formulations: The maximum Estimated Environmental
Concentrations (EECs) for different substrates expected immediately
after application of the non-granular formulations are presented in the
following table. EECs were estimated for each use pattern.
EEC Immediately After Application for Different Application Rates in Different Substrates (in ppm from
Hoerger and Kenaga (1972))
Substrate
Short Grass
Long Grass
Leaves and
Leafy Crops
Forage and
Insects
Seeds
Fruits
1.5 Ibs
360
165
187
87
18
10
2 Ibs
480
220
250
116
21
14
3.6 Ibs
864
396
450
209
43
25
4 Ibs
960
440
500
232
48
28
6 Ibs
1440
660
750
348
72
42
7.2 Ibs
1728
792
900
417
86
50
12 Ibs
2280
1320
1500
696
144
84
13.5 Ibs
3240
1485
1687
783
162
94
The risk quotients = EEC/LC50, based on the above EECs are
presented in the following table. The LC50 used in the calculation is
10,000 ppm. 10,000 ppm was used because all of the results of the
dietary toxicity studies are expressed as greater than either 5,000 ppm or
31
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10,000 ppm. However, the only study in which an effect was actually
observed was for the bobwhite quail where there were 3 mortalities out
of 10 at the highest dose tested, which was 5,000 ppm. Extrapolation to
estimate an LC50 value from this information resulted in an estimate of
11,346 ppm. This together with the information available from the
other studies suggests that 10,000 ppm is an appropriate estimate of the
LC50.
Avian Acute Risk Quotients for Different Application Rates and Different Substrates
Substrate
Short Grass
Long Grass
Leaves and Leafy
Crops
Forage and Insects
Seeds
Fruits
1.51bs
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
21bs
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
3.6 Ibs
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
4 Ibs
0.1
<0.1
<0.1
<0.1
<0.1
<0.1
6 Ibs
0.1
<0.1
<0.1
<0.1
<0.1
<0.1
7.2 Ibs
0.2
<0.1
0.1
<0.1
<0.1
<0.1
12 Ibs
0.2
0.1
0.2
<0.1
<0.1
<0.1
13.5 Ibs
0.3
0.1
0.2
0.1
<0.1
<0.1
The restricted use LOG, which is 0.2, is exceeded for the three
highest application rates for shortgrass, and for leaves and leafy crops
for the two highest application rates. The only acute dietary study in
which there were effects showed only 3 birds out of 10 dying at the
highest dose tested, 5,000 ppm. No mortalities occurred in any of the
studies at a dose around 3,240 ppm which is the highest residue level.
In light of the responses seen in the studies there appears to be little
concern for acute effects to grazing birds. The LOG for endangered
species, which is 0.1, is triggered for short grass at application rates of 4
Ibs. or greater; for long grass at application rates of 12 Ibs. or greater;
for leaves and leafy crops at 7.2 Ibs. or greater; and for forage and
insects at 13.5 Ibs. However, due to the relatively low risk quotients for
the unrefined assessment, this risk is not a major concern.
Avian Chronic Effects
The avian reproduction studies show that the NOEC for the
bobwhite quail is < 100 based on effects to the 14 day survivors weight
at 100 ppm. However, no effects were seen at the other doses tested
which were 300 and 1,000 ppm. The NOEC for the mallard duck is
> 1,000 ppm based on no statistically significant effects for any of the
parameters tested. However, a weight reduction trend was observed in
the parental male body weight. There was no significant dose response
32
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in any of the avian reproduction studies. Testing at higher doses would
provide more confidence in the NOEC value. However, based on the
results of these two studies an NOEC of 1,000 ppm was used in the risk
assessment.
A calculation of the risk quotients = EEC/LC50, based on the
above EECs and an NOEC of 1,000 ppm is presented in the following
table:
Avian Chronic Risk Quotients for Different Application Rates and Different Substrates
Substrate
Short Grass
Long Grass
Leaves and Leafy
Crops
Forage and
Insects
Seeds
Fruits
1.51bs
< 1
< 1
< 1
< 1
< 1
< 1
21bs
< 1
< 1
< 1
< 1
< 1
< 1
3.6 Ibs
< 1
< 1
< 1
< 1
< 1
< 1
4 Ibs
1.0
< 1
< 1
< 1
< 1
< 1
6 Ibs
1.4
< 1
< 1
< 1
< 1
< 1
7.2 Ibs
1.7
< 1
1.0
< 1
< 1
< 1
12 Ibs
2.3
1.3
1.5
< 1
< 1
< 1
13.5 Ibs
3.2
1.5
1.7
0.1
< 1
< 1
No chronic effects for birds are expected when the application
rate is less than 4 Ibs ai/A. Included in this use rate are alfalfa,
sugarcane, pineapple, Christmas trees and conifer release. There may
be a possibility of chronic effects at higher application rates, where the
LOG is greater than 1, but this is not certain. Hexazinone is a persistent
chemical but, considering a single application per year and its low
bioaccumulation, the likelihood for chronic avian concerns even at rates
greater than 6.0 Ibs ai/A is minimal.
Mammalian Acute Oral and Subacute Dietary Effects
The LC50 for small mammals is estimated from the LD50 of the
rat (1200 mg/kg) and the body weight and food consumption of three
representative small mammals. The LC50 is equal to the LD50 of the
rat multiplied by the ratio of the body weight to the daily food
consumption. A representative of a herbivore (meadow vole), a
granivore (deer mouse), and of an insectivore (least shrew) are used to
estimate the risk to small mammals. The estimated LCSOs are shown in
the following table:
33
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Estimated LC50 for Three Small Mammals Representing Different Food Habits
Species
Meadow Vole
Deer Mouse
Least Shrew
Body Weight
46 g
13 g
5g
Food
Consumption
28.1 g
2.1 R
5.5g
Estimated
LC50
1964.4
7428.5
1090.9
Expected
Food
grass
seeds
insects
The above estimated LCSOs for each organism were used with
the maximum residues [from Hoerger and Kenaga (1972)], resulting
from each application rate to calculate the risk quotients (EEC/LC50)
for small mammals. The results are shown in the following table:
Risk Quotients and LOCs for Three Small Mammals Assuming Maximum Residues
Use Sites
Christmas Tree
Plantations, Forest
Plantings
Sugarcane, pineapple
Forestry
Drainage Systems,
Industrial Areas, Non
Agricultural Rights of
Way
Application Rate
2 Ibs ai/acre
3.6 Ibs ai/acre
6.0 Ibs ai/acre
12 Ibs ai/acre
Species
meadow
vole
deer mouse
least shrew
meadow
vole
deer mouse
least shrew
meadow
vole
deer mouse
least shrew
meadow
vole
deer mouse
least shrew
Maximum
EEC (expected
food)
480 ppm
(grass)
21 ppm (seeds)
116 ppm
(insects)
864 ppm
(grass)
43 ppm (seeds)
209 ppm
(insects)
1440 ppm
(grass)
48 ppm (seeds)
417 ppm
(insects)
2280 ppm
(grass)
144 ppm
(seeds)
696 ppm
(insects)
Risk Quotient
(EEC/LC50)
0.2
0.002
0.1
0.43
0.003
0.19
0.73
0.006
0.38
1.16
0.02
0.63
LOG
*HR > 0.5
*RU > 0.2
*ES^0.1
HR > 0.5
RU > 0.2
ES > 0.1
HR > 0.5
RU > 0.2
ES^O.l
HR > 0.5
RU > 0.2
ES > 0.1
34
-------
Risk Quotients and LOCs for Three Small Mammals Assuming Maximum Residues
Use Sites
Industrial Areas, Non
Agricultural Rights of
Way, Fencerows,
Hedgerows
Application Rate
13.5 Ibs ai/acre
Species
meadow
vole
deer mouse
least shrew
Maximum
EEC (expected
food)
3240 ppm
(grass)
162 ppm
(seeds)
783 ppm
(insects)
Risk Quotient
(EEC/LC50)
1.65
0.02
0.72
LOG
HR > 0.5
RU > 0.2
ES > 0.1
HR = High Risk
RU = Restricted Use
ES = Endangered Species
The risk quotients range from < 0.1 to 1.65. Because some of
these risk quotients exceed the established LOCs, a refined exposure
assessment was done. Typical residues were used for the EEC's in the
following table to calculate the risk quotients.
Risk Quotients and LOCs for Three Small Mammals Assuming Typical Residues
Use Sites
Christmas Tree
Plantations, Forest
Plantings
Sugarcane, pineapple
Forestry
Drainage Systems,
Industrial Areas, Non
agricultural rights of
way
Application Rate
2 Ibs ai/acre
3.6 Ibs ai/acre
6.0 Ibs ai/acre
12 Ib ai/acre
Species
meadow vole
deer mouse
least shrew
meadow vole
deer mouse
least shrew
meadow vole
deer mouse
least shrew
meadow vole
deer mouse
least shrew
Typical EEC
(expected food)
184 ppm (grass)
6 ppm (seeds)
66 ppm (insects)
331.2 ppm
(grass)
10.8 ppm (seeds)
118. 8 ppm
(insects)
552 ppm (grass)
18 ppm (seeds)
198 ppm (insects)
1104 ppm (grass)
36 ppm (seeds)
396 ppm (insects)
Risk Quotient
(EEC/LC50)
0.09
0.0008
0.06
0.16
0.001
0.1
0.28
0.002
0.18
0.56
0.004
0.36
LOG
HR > 0.5
RU > 0.2
ES > 0.1
HR > 0.5
RU > 0.2
ES > 0.1
HR > 0.5
RU > 0.2
ES > 0.1
HR > 0.5
RU > 0.2
ES > 0.1
35
-------
Risk Quotients and LOCs for Three Small Mammals Assuming Typical Residues
Use Sites
Industrial areas, Non
agricultural rights of
way fencerows, hedge
rows
Application Rate
13.5 Ibs ai/acre
Species
meadow vole
deer mouse
least shrew
Typical EEC
(expected food)
1242 ppm (grass)
40.5 ppm (seeds)
445.5 ppm
(insects)
Risk Quotient
(EEC/LC50)
0.6
0.005
0.41
LOG
HR > 0.5
RU > 0.2
ES > 0.1
Using typical residues, the risk quotients range from < 0.1 to
0.6. The endangered species LOG of 0.1 is exceeded, for grass and
insect eating mammals, at use rates of 3.6 Ibs ai/acre or greater; the
restricted use LOG of 0.2 is exceeded, for grass and insect eating
mammals, at use rates of 6.0 Ibs ai/acre or greater; and the high risk
LOG is exceeded, for grass and insect eating mammals, at 12 and 13.5
Ibs ai/acre. The use patterns represented by these application rates are
likely to include the habitat or feeding grounds for small mammals.
Risk to Aquatic Animals
Estimated Environmental Concentrations
Ground Application: Using an application rate of 13.5 Ib ai/acre,
which is the highest application rate, estimated runoff to a 6 foot deep
water body results in an EEC of 412 ppb for ground application, as
illustrated in the calculations below.
Runoff of a pesticide from ground applications is estimated by
multiplying the application rate (Ibs ai/acre) by the percent runoff from a
10-acre drainage basin into a 1 acre water body. Based on hexazinone's
solubility (2.98 g/lOOg) the maximum pesticide runoff, which is 5%,
was assumed.
Runoff = application rate (Ibs ai/acre) X % Runoff X 10-acre drainage
basin
= 13.51bsX0.05X 10
= 6.75 Ibs
EEC = runoff (Ibs ai) X EEC (ppb) of a 1 Ib ai/acre direct application
for a 6-ft. deep water body
36
-------
= 6.75 X 61 ppb
= 411.75 ppb
Aerial Application: Using an application rate of 1.5 Ib ai/acre, which
is the lowest application rate, estimated residues in a 6 foot deep water
body, resulting from aerial application, are 32 ppb. These calculations
are illustrated below.
Residues of a pesticide from aerial applications are estimated by
multiplying the application rate (Ibs ai/acre) adjusted by the aerial
application efficiency (60%); by the percent runoff (based on solubility)
from a 10-acre drainage basin into a 1 acre water body; and adding this
runoff amount to the estimated spray drift which is assumed to be 5% in
the absence of spray drift data. Based on hexazinone's solubility (3.30
ppm) the maximum pesticide runoff, which is 5%, was assumed.
Runoff = application rate (Ibs ai/acre) X application efficiency X
%runoff X 10-acre drainage basin
= 1.51bsX0.6X0.05X 10
= .45 Ibs
Drift = application rate X %drift
= 1.5 Ibs X 0.05
= 0.075 Ibs
EEC = total Ibs runoff + total drift X EEC (ppb) of a 1 Ib ai/acre direct
application for a 6 foot deep water body
= .525X61 ppb
= 32.0 ppb
The following table shows the EECs for ground and aerial
applications using the maximum use rates for each use pattern.
37
-------
EECs Expected Immediately After Application to a Six Foot Deep Water Body
Use Pattern
Terrestrial Feed Crop Use, Alfalfa
Terrestrial Non-Food Crop, Christmas Tree
Terrestrial Food Use, Sugarcane and Pineapple
Forestry, Conifer Release
Forestry
Terrestrial Non-Food Crop, Non Agricultural
Rights of Way, Florida Only
Terrestrial Non-Food Crop and Aquatic Non-Food
Drainage Systems
Terrestrial Non-Food Crop and Aquatic Non-Food
Industrial, Texas Only
Max. Application
(Ibs ai/A)
1.5
2
3.6
4
6
7.2
12
13.5
EEC Ground
Application
45.7ppb
61 ppb
109.8ppb
122 ppb
183 ppb
219. 6 ppb
366 ppb
41 1.7 ppb
EEC Aerial
Application
32 ppb
42.7 ppb
72.8 ppb
n/a
n/a
n/a
256.2 ppb
n\a
No LOC's for fish or aquatic invertebrates are exceeded by the
highest EEC, which is 412 ppb for the 13.5 Ib ai/acre application rate
and using the most sensitive species in each category. The freshwater
acute risk quotients (RQ) for this application rate are: 0 for aquatic
invertebrates (RQ = .4/152) and 0 for fish (RQ= .4/274). The
freshwater chronic risk quotients are: 0.02 (RQ= .4/20) for aquatic
invertebrates and 0.02 (RQ = .4/24.6) for fish. The estuarine/marine
risk quotient for the most sensitive species, the grass shrimp, is .01
(RQ=.4/78).
Risk to Terrestrial, Semi-Aquatic and Aquatic Plants
Exposure of terrestrial and aquatic plants to hexazinone is
estimated based on expected runoff from a maximum application rate for
ground application; and from runoff and drift for aerial application.
Direct applications by ground on forests and rights of way are also a
concern because endangered and other non-target plants growing in
forests and rights-of-way will be directly exposed to the pesticide.
Terrestrial Plants: The use of hexazinone exceeds the levels of concern
for nontarget terrestrial endangered and non-endangered plants. The
levels of concern are exceeded for all application rates for both ground
and aerial application. The following table contains the EECs for
different scenarios and the corresponding risk quotients.
38
-------
The runoff scenario used for areas adjacent to a use site is 1
treated acre draining into a 1 acre site. The scenario for wet areas is 10
treated acres draining into a 1 acre site. Aerial application is assumed to
result in 5% drift.
Risk to Terrestrial and Semi-Aquatic Plants Resulting from the Use of Hexazinone
Use Site
Agricultural
Rights of
Way
Alfalfa
Forestry
Non-
Agricultural
Areas
Application
Rate
1.1251bs
ai/acre
1.5 Ibs ai/acre
6.0 Ibs ai/acre
13. 5 Ibs
ai/acre
EEC (Ibs ai/acre) and Risk Quotients (EEC/EC25)
Adjacent to a Site
Ground1
Ground1
Aerial2
Aerial3
Ground1
Aerial2
Aerial3
Ground1
EEC
0.056
0.075
0.12
0.075
0.3
0.48
0.3
0.675
RQ
8.8
11.9
19
6.8
47.6
76.2
27.2
107.1
Wet Areas
EEC
0.56
0.75
0.53
0.075
3.0
2.1
0.3
6.75
RQ
88.9
119.0
83.3
48.2
476
333
27.2
1071
Treated Site
(Direct
Application)
EEC
1.125
n/a
n/a
n/a
6.0
3.64
13.5
RQ
178.5
n/a
n/a
n/a
952
327.24
2142.8
LOG
1
(runoff), EC25 = 0.0063 Ibs ai/acre Seedling Emergence Study
(runoff + drift), EC25 = 0.0063 Seedling Emergence Study
(drift only), EC25 = 0.011 Ibs ai/acre Vegetative Vigor Study
(direct), EC25 = 0.011 Ibs ai/acre Vegetative Vigor Study
Aquatic Plants: The use of hexazinone exceeds the levels of concern
for aquatic plants (freshwater and estuarine/marine). The levels of
concern are exceeded for all application rates using ground or aerial
application.
The EECs for all uses except alfalfa are calculated based on
runoff from a 10 acre drainage basin into a 1 acre pond which is 6
inches deep. The alfalfa scenario is a 10 acre drainage basin into a 1
acre pond which is 6 feet deep. Aerial application is assumed to result
in 5% drift.
39
-------
Risk to Aquatic Plants Resulting from the Use of Hexazinone; RQ = EEC/EC50; EC50 is 7 ppb for Selenastrum
capricornutum
Use Site
Agricultural
Rights of Way
Alfalfa
Forestry
Non- Agricultural
Areas
Application
Rate
1.1251bs
ai/acre
1.5 Ibs ai/acre
6.0 Ibs ai/acre
13. 5 Ibs
ai/acre
Direct/ Indirect
Application
Indirect
Direct
Indirect
Indirect
Direct
Indirect
Direct
EEC (ppb) and Risk Quotient
Ground Application
EEC
411
852.8
47.8
2202
4404
4954.5
9909
RQ
58.7
117.9
6.5
314.6
629.1
707.8
1415.6
Aerial Ap
EEC
n/a
n/a
32.3
1541.4
2642.4
n/a
n/a
plication
RQ
n/a
n/a
4.6
220.2
377.4
n/a
n/a
LOG
1
EEC Calculation for Terrestrial Plant Exposure
Application Rate - 1.125 Ibs ai/acre
1. Unincorporated Ground Application
1.125 Ibs ai/acre X 5% runoff X 1 acres = 0.056 Ibs ai
2. Direct Application
1.125 Ibs ai/acre
Application Rate - 1.5 Ibs ai/acre
1. Unincorporated Ground Application
1.5 Ibs ai/acre X 5% runoff X 1 acres = 0.075 Ibs ai
2. Aerial Application
a. Runoff: (from site after application)
1.5 Ibs ai/acre X 60% efficiency X 5% runoff X 1 acres = 0.045 Ibs
ai
b. Drift: (from site during application)
1.5 Ibs ai/acre X 5% (drift) = 0.075 Ibs ai
c. Total Loading = Runoff + Drift
= 0.045 + 0.075 = 0.12 Ibs ai
40
-------
3. Aerial Drift Calculation
Drift: (from site during application)
1.5 Ibs ai/acre X 5% (drift) = 0.075 Ibs ai
Application Rate - 6 Ibs ai/acre
1. Unincorporated Ground Application
6.0 Ibs ai/acre X 5% runoff X 1 acres = 0.3 Ibs ai
2. Aerial Application
a. Runoff: (from site after application)
6 Ibs ai/acre X 60% efficiency X 5% runoff X 1 acres = 0.18 Ibs ai
b. Drift: (from site during application)
6.0 Ibs ai/acre X 5% (drift) = 0.3 Ibs ai
c. Total Loading = Runoff + Drift
= 0.18 + 0.3 = 0.48 Ibs ai
3. Aerial Drift Calculation
Drift: (from site during application)
6 Ibs ai/acre X 5% (drift) = 0.3 Ibs ai
4. Direct Application (ground)
6 Ibs ai/acre
5. Direct Application (aerial)
6 Ibs ai/acre X 60% efficiency = 3.6 Ibs ai
Application Rate - 13.5 Ibs ai/acre
1. Unincorporated Ground Application
13.5 Ibs ai/acre X 5% runoff X 1 acres = 0.675 Ibs ai
2. Direct Application
13.5 Ibs ai/acre
41
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EEC Calculation for Semi-Aquatic Plant Exposure [Semi-Aquatic plants are
plants that require saturated soils for some part of their life cycle (wetlands,
marshes, bogs)]
Application Rate - 1.125 Ibs ai/acre
1. Unincorporated Ground Application
1.125 Ibs ai/acre X 5% runoff X 10 acres = 0.56 Ibs ai
2. Direct Application
1.125 Ibs ai/acre
Application Rate - 1.5 Ibs ai/acre
1. Unincorporated Ground Application
1.5 Ibs ai/acre X 5% runoff X 10 acres = 0.75 Ibs ai
2. Aerial Application
a. Runoff: (from site after application)
1.5 Ibs ai/acre X 60% efficiency X 5% runoff X 10 acres = 0.45
Ibs ai
b. Drift: (from site during application)
1.5 Ibs ai/acre X 5% (drift) = 0.075 Ibs ai
c. Total Loading = Runoff + Drift
= 0.45 + 0.75 = 0.53 Ibs ai
3. Aerial Drift Calculation
Drift: (from site during application)
1.5 Ibs ai/acre X 5% (drift) = 0.075 Ibs ai
Application Rate - 6 Ibs ai/acre
1. Unincorporated Ground Application
6.0 Ibs ai/acre X 5% runoff X 10 acres = 3 Ibs ai
2. Aerial Application
a. Runoff: (from site after application)
6 Ibs ai/acre X 60% efficiency X 5% runoff X 10 acres = 1.8 Ibs ai
b. Drift: (from site during application)
6.0 Ibs ai/acre X 5% (drift) = 0.3 Ibs ai
42
-------
c. Total Loading = Runoff + Drift
= 1.8 + 0.3 = 2.1 Ibsai
3. Aerial Drift Calculation
Drift: (from site during application)
6.0 Ibs ai/acre X 5% (drift) = 0.3 Ibs ai
4. Direct Application
6.0 Ibs ai/acre
Application Rate - 13.5 Ibs ai/acre
1. Unincorporated Ground Application
13.5 Ibs ai/acre X 5% runoff X 10 acres = 6.75 Ibs ai
2. Direct Application
13.5 Ibs ai/acre
EEC Calculation for Aquatic Plant Exposure
Application Rate - 1.125 Ibs ai/acre (Agricultural Rights of Way)
1. Unincorporated Ground Application
a. Indirect Application
1.125 Ibs ai/acre X 5% runoff X 10 acres = 0.56 Ibs ai
EEC of 1 Ib ai direct application to 1 acre water body 6 inches deep is
734 ppb
Therefore: EEC = 734 ppb X 0.56 Ibs = 411.04 ppb
b. Direct Application
1.125 Ibs ai/acre
Therefore: EEC = 1.125 Ibs ai X 734 ppb = 825.75 ppb
Application Rate - 1.5 Ibs ai/acre (Alfalfa)
1. Unincorporated Ground Application
a. Indirect Application
1.5 Ibs ai/acre X 5% runoff X 10 acres = 0.75 Ibs ai
43
-------
EEC of 1 Ib ai direct application to 1 acre water body 6 feet deep is 61
ppb
Therefore: EEC = 61 ppb X 0.75 Ibs = 45.75 ppb
2. Aerial Application
a. Indirect Application
i. Runoff: (from site after application)
1.5 Ibs ai/acre X 60% efficiency X 5% runoff X 10 acres =
0.45 Ibs ai
ii. Drift: (from site during application)
1.5 Ibs ai/acre X 5% (drift) = 0.075 Ibs ai
iii. Total Loading = Runoff + Drift
= 0.45 + 0.075 = 0.53 Ibs ai
EEC of 1 Ib ai direct application to 1 acre water body 6 feet deep is 61
ppb.
Therefore: EEC = 61 ppb X 0.53 Ibs ai = 32.33 ppb
Application Rate - 6 Ibs ai/acre (Forestry)
1. Unincorporated Ground Application
a. Indirect Application
6.0 Ibs ai/acre X 5% runoff X 10 acres = 3 Ibs ai
EEC of 1 Ib ai direct application to 1 acre water body 6 inches deep is
734 ppb
Therefore: EEC = 734 ppb X 3 Ibs ai = 2202 ppb
b. Direct Application
6.0 Ibs ai/acre
EEC of 1 Ib ai direct application to 1 acre water body 6 inches deep is
734 ppb
Therefore: EEC = 6.0 Ibs ai X 734 ppb = 4404 ppb
44
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2. Aerial Application
a. Indirect Application
i. Runoff: (from site after application)
6 Ibs ai/acre X 60% efficiency X 5% runoff X 10 acres =
1.8 Ibs ai
ii. Drift: (from site during application)
6.0 Ibs ai/acre X 5% (drift) = 0.3 Ibs ai
iii. Total Loading = Runoff + Drift
= 1.8 + 0.3 = 2.1 Ibsai
EEC of 1 Ib ai direct application to 1 acre water body 6 inches deep is
734 ppb
Therefore: EEC = 734 ppb X 2.1 Ibs ai = 1541.2 ppb
b. Direct Application
6.0 Ibs ai/acre X 60% efficiency = 3.6 Ibs ai/acre
EEC of 1 Ib ai direct application to 1 acre water body 6 inches deep is
734 ppb
Therefore: EEC = 734 ppb X 3.6 Ibs ai = 2642.4 ppb
Application Rate - 13.5 Ibs ai/acre (Non-Agricultural Areas)
1. Unincorporated Ground Application
a. Indirect Application
13.5 Ibs ai/acre X 5% runoff X 10 acres = 6.75 Ibs ai
EEC of 1 Ib ai direct application to 1 acre water body 6 inches deep is
734 ppb
Therefore: EEC = 734 ppb X 6.75 Ibs = 4954.8 ppb
b. Direct Application
13.5 Ibs ai/acre
EEC of 1 Ib ai direct application to 1 acre water body 6 inches deep is
734 ppb.
45
-------
Therefore: EEC = 13.5 Ibs ai X 734 ppb = 9909 ppb
Risk to Endangered Species
Hexazinone exceeds the endangered species LOCs for both
aquatic and terrestrial plants at all use rates. The risk quotients range
from 4.6 to 2142.8.
No concern exists for endangered aquatic animals. Hexazinone
exceeds the endangered species level of concern, using typical residues,
for grass and insect eating mammals at use rates of 3.6 Ibs ai/acre or
greater. Using the maximum application rate for the granular
formulation, which is 12 Ibs ai/acre, and assuming no soil incorporation
results in a risk quotient of 0.3 which exceeds the acute avian LOG for
endangered birds.
At the present time EPA is working with the Fish and Wildlife
Service and other Federal and State agencies to develop a program to
avoid jeopardizing the continued existence of the identified species by
the use of pesticides. When this program goes into effect endangered
species precautionary labeling will be required.
3. Data Requirements
Ecological Effects:
• 123-1 (a) Seed Germination/Seedling Emergence (cucumber,
onion, pea)
• 123-l(b) Vegetative Vigor (cucumber)
Environmental Fate:
163-1 Leaching/Adsorption/Desorption
164-2 Aquatic Field Dissipation (not required if all aquatic uses
are removed from hexazinone product labels)
166-1 Prospective Groundwater Monitoring Study
201-1 Droplet Size Spectrum
202-1 Drift Field Evaluation-
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4. Summary of LOG Exceedance and Risk Characterization
a. Ecological Effects
Hexazinone exceeds the levels of concern for both endangered
and non-endangered aquatic and terrestrial plants. The risk quotients
range from 4.6 to 2142.8 depending on the application rate.
Contamination of aquatic sites within or adjacent to treated areas
could be of ecological significance and may be exacerbated by the
persistence and mobility of the chemical. Aquatic plants are an
important component of the ecosystem. Algae are the link between solar
radiation, aquatic animals and humans which are dependent on the
oxygen produced by algae during photosynthesis. Algae are responsible
for maintaining the quality of the aquatic habitat for fish, while at the
same time providing food for fish either directly or indirectly. Thus,
effects to aquatic plants expected from the use of hexazinone may alter
aquatic ecosystems. The severity of these effects is dependent upon the
frequency of the exposure to hexazinone and the nature of the receiving
body. For example, the conifer release may be representative of a
situation in which the pesticide is used only once in several years and the
receiving body is a stream. In contrast, sugarcane fields may be treated
once per year and drain into a shallow marsh. A much greater effect
would be expected to occur from the latter use.
Hexazinone exceeds levels of concern for both endangered and
non-endangered small mammals at several of the higher application
rates. Using typical residues as the EEC estimates, the risk quotients
range from < 0.1 to 0.6. Using the maximum application rate for the
granular formulation, which is 4 Ibs ai/acre, and assuming no soil
incorporation results in a risk quotient of 0.1 which is the acute avian
LOG for endangered birds.
Risk mitigation measures for ecological effects are discussed in
Parts IV and V of this document.
b. Ground Water
Hexazinone exceeds the following Levels of Concern for ground
water:
Ground Water Quality: Hexazinone exhibits many of the properties
and characteristics associated with chemicals that have been detected in
ground water. Considering the mode of activation of the chemical; i.e.,
47
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rainfall within two weeks of an application, there is a strong possibility
of movement to ground water, especially in vulnerable areas. For these
reasons, hexazinone use is likely to have a significant impact on ground-
water quality. Hexazinone has been detected in ground water in Hawaii
(0.06-0.72 ppb), Florida (0.12-2.90 ppb), Maine (0.2-29 ppb), and
North Carolina (0.74-34 ppb), although well below the Health Advisory
Level.
Based on this information, the Agency is requiring a ground
water advisory and other risk mitigation measures that are discussed in
Parts IV and V of this document.
The ecological effects assessment indicates that hexazinone
presents a concern to terrestrial and aquatic plants. In areas where
irrigation water is contaminated with hexazinone, or where ground water
discharges to surface water, hexazinone residues in ground water could
pose a threat to plants.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether products
containing the active ingredients are eligible for reregistration. The Agency has
previously identified and required the submission of the generic (i.e. active ingredient
specific) data required to support reregistration of products containing hexazinone
active ingredients. The Agency has completed its review of these generic data, and has
determined that the data are sufficient to support reregistration of all products
containing hexazinone. Appendix B identifies the generic data requirements that the
Agency reviewed as part of its determination of reregistration eligibility of hexazinone,
and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of hexazinone and to determine that hexazinone can be used without
resulting in unreasonable adverse effects to humans and the environment. The Agency
therefore finds that all products containing hexazinone as the active ingredients are
eligible for reregistration. The reregistration of particular products is addressed in
Section V of this document.
The Agency made its reregistration eligibility determination based upon the
target data base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data, and the data identified in Appendix B.
Although the Agency has found that all uses of hexazinone are eligible for
48
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reregistration, it should be understood that the Agency may take appropriate regulatory
action, and/or require the submission of additional data to support the registration of
products containing hexazinone, if new information comes to the Agency's attention or
if the data requirements for registration (or the guidelines for generating such data)
change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient
hexazinone, the Agency has sufficient information on the health effects of
hexazinone and on its potential for causing adverse effects in fish and wildlife
and the environment. Therefore, the Agency concludes that products containing
hexazinone for all uses are eligible for reregistration.
The Agency has determined that hexazinone products, labeled and used
as specified in this Reregistration Eligibility Decision, will not pose
unreasonable risks or adverse effects to humans or the environment. Tolerances
for alfalfa green forage, alfalfa hay, grass hay, meat/meat byproducts and milk
could not be reassessed, however enough data were available to conduct a risk
assessment. The Agency believes that existing tolerances are protective until
data are available for reassessment.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of hexazinone are eligible for
reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for
hexazinone. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1. Tolerance Reassessment
TOLERANCE REASSESSMENT SUMMARY
The combined limit of quantitation for hexazinone residues by the
method in PAM, Vol. II, is 0.55 ppm. The highest limit of quantitation for an
individual hexazinone metabolite is 0.2 ppm, for metabolite C. The tolerance
level for non-detectable residues will be 0.2 ppm. Metabolite F should be
included in the tolerance expression if detected by the current analytical
method. If not detected, it will be accounted for during the risk assessment.
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Tolerances Listed Under 40 CFR §180.396:
The tolerances listed in 40 CFR §180.396 are for the combined residues
of hexazinone and its metabolites (calculated as hexazinone) in or on plant and
animal commodities. Sufficient data are available to ascertain the adequacy of
the established tolerance listed in 40 CFR for blueberries, pineapple, and
sugarcane, provided all labels are amended to impose appropriate PHIs, and
provided the sugarcane tolerance is changed to a tolerance with a regional
registration in a separate subsection of 40 CFR 180.396. Data show that
hexazinone concentrates in certain processed fractions of alfalfa, pineapple, and
sugarcane. The Agency has determined that establishing food and feed additive
tolerances for these commodities is appropriate and consistent with the Delaney
Clause of Section 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA).
A tolerance for residues on grass hay is pending under PP 1F3967.
As there are no Codex tolerances for residues of hexazinone and its
metabolites in plant and animal commodities, there is no question with respect
to Codex/U.S. tolerance compatibility.
TOLERANCE REASSESSMENT SUMMARY
Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/ Correct
Commodity Definition
Tolerances listed under 180.396
Alfalfa green forage
Alfalfa hay
Blueberries
Cattle, fat
Cattle, mbyp
Cattle, meat
Eggs
Goats, fat
Goats, mbyp
Goats, meat
Grasses, pasture
Grasses, range
Grass, hay
Hogs, fat
Hogs, mbyp
Hogs, meat
Horses, fat
Horses, mbyp
2.0
8.0
0.2
0.1
0.1
0.1
0.1
0.1
0.1
0.1
10
10
30 (pending)
0.1
0.1
0.1
0.1
0.1
Reserved1
Reserved1
0.22
Reserved1
Revoke3
Reserved1
Combine into one
tolerance at 10 ppm
Reserved1
Reserved1
Alfalfa, forage
Alfalfa, hay
Grass, forage
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Commodity
Horses, meat
Milk
Pineapple (whole fruit)
Pineapple, fodder
Pineapple, forage
Poultry, fat
Poultry, mbyp
Poultry, meat
Sheep, fat
Sheep, mbyp
Sheep, meat
Sugarcane
Current Tolerance
(ppm)
0.1
0.1
0.5
5.0
5.0
0.1
0.1
0.1
0.1
0.1
0.1
0.2
Tolerance
Reassessment (ppm)
0.22
Revoke4
Revoke4
Revoke3
Reserved1
0.22'5
Comment/ Correct
Commodity Definition
Pineapples
1. Data on hexazinone are inadequate to reassess tolerances.
2. Tolerances for non-detectable residues in plant commodities will be set at 0.2 ppm, the limit of quantitation for
metabolite C (blueberries, sugarcane, pineapple).
3. The maximum residue expected in poultry tissues would be 0.005 ppm, an order of magnitude below the limit of
detection for hexazinone metabolites. Tolerances for hexazinone in poultry commodities are not required and the
existing tolerances for these commodities should be revoked.
4. Not a regulated raw agricultural commodity (RAC).
5. Residue data were not provided for Florida, the major growing site in the U.S. for sugarcane. Revoke tolerance and
reestablish as a tolerance with regional registration placed in a separate section of 40 CFR 180.396.
The Agency cannot conclude that hexazinone has been found to induce
cancer within the meaning of the Delaney clause and therefore food and feed
additive regulations are not barred by the Delaney clause of the Federal Food
Drug and Cosmetic Act. Currently there are no existing food or feed additive
tolerances for hexazinone. Food/feed additive tolerances must be established
for sugarcane molasses, alfalfa meal, and pineapple processing residue.
Both food and feed additive tolerance petitions have been submitted for
sugarcane molasses and bagasse (FAP #4H5683). The proposed food and feed
additive tolerances of 0.5 ppm on sugarcane molasses are appropriate. The
proposed tolerance of 0.5 ppm on sugarcane bagasse is not needed because
sugarcane bagasse is no longer considered a major livestock feed; this proposal
should be withdrawn.
Residue data were not submitted and are not required on alfalfa meal,
but residues can be translated from alfalfa hay to meal because of similar dry
matter content (90% in hay, 91% in meal). Accordingly, a food additive
tolerance of 8.0 ppm for alfalfa meal is required.
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Residues of metabolite B have been shown to concentrate in bran
(pineapple processing residue), but the concentration factor could not be
determined because residues of parent and metabolites A through F were non-
detectable on the harvested fruit. Data have been generated on pineapple
processing residue; once these data have been evaluated, a feed additive
tolerance for pineapple processing residue will be required.
2. Restricted Use Classification
Hexazinone is not currently classified for restricted use and no change in
its classification is being imposed by this document. However, hexazinone may
be considered for restricted use for ground water concerns once the Restricted
Use Rule is finalized.
3. Reference Dose
The RfD is 0.05 mg/kg body weight/day, based on a No Observable
Effect Level (NOEL) of 5.0 mg/kg bwt/day and an uncertainty factor of 100.
The NOEL was based on a one year feeding study in dogs (MRID 42162301)
which demonstrated liver effects in both males and females at 38 mg/kg
bwt/day (OPP RfD Peer Review Committee on February 11, 1993). The ARC
for the overall U.S. population from all tolerances is 3.5 x 10 3 mg/kg bwt/day
or 7% of the RfD. The subgroup most highly exposed, non-nursing infants (< 1
yr) has an ARC from all uses of 2.0 x 102 mg/kg bwt/day, representing 40% of
the RfD. The children (1-6 yrs) subgroup has an ARC from all tolerances of
1.0 x 102 mg/kg bwt/day, or 20% of the RfD. Anticipated residues were used
for all commodities. However, a source of overestimation exists in that 100
percent crop treated was assumed for all commodities.
4. Cancer Classification
Hexazinone was classified as to its carcinogenic potential as a "Group
D" chemical by the OPP Carcinogenicity Peer Review Committee on July 27,
1994.
5. Risk Mitigation
Groundwater Concerns: Due to groundwater concerns, the following
mitigation steps are required:
• Hexazinone has been detected in ground water. Therefore, all product
labels must carry a groundwater advisory. The label language for
this advisory can be found in Part V of this document.
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• Registrants must report any domestic hexazinone ground water
detections at any levels to the Agency.
• Because of particular ground water concerns in Maine, the Agency is
requiring that duPont prepare a report of the ongoing research in that
state in regard to ground water detections. The details of this
requirement are contained in Part V of this document.
• DuPont is also required to submit educational materials that are
currently being developed to the Agency. These materials should be in
specific regard to product stewardship and address the potential of
ground water contamination from the use of hexazinone.
In addition to these measures, the Agency is requiring that a prospective
ground water monitoring study be conducted for hexazinone to determine the
potential of this chemical to leach to ground water. Site selection will be done
in consultation with the Agency.
Surface Water Concerns: Due to surface water concerns, the following
mitigation step is required:
• DuPont, the technical manufacturer of hexazinone, is in the process of
consolidating precautionary label language in regard to surface water
contamination for all of their hexazinone products. After the Agency
has reviewed and approved these label amendments, all registrants will
be required to amend their hexazinone labels in the same way.
Risk to Non-Target Terrestrial and Aquatic Plants and Small Mammals:
Due to the risk to non-target plants, the following mitigation step is required:
• Reduction of the maximum application rate from 13.5 Ib ai/acre to 8 Ib
ai/acre.
6. Spray Drift Label Advisory
In order to inform the user of best management practices that would
minimize spray drift from the target site, the Agency is currently preparing
spray drift labeling statements. This future labeling may be required for all
hexazinone products that may be applied aerially to agricultural crops.
7. Endangered Species Statement
Hexazinone exceeds the level of concern at all use rates for endangered
aquatic and terrestrial plants that may be exposed. The risk quotients range
from 4.6 to 2142.8.
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Hexazinone exceeds levels of concern for endangered small mammals at
use rates of 3.6 Ibs ai/acre and up. Using typical residues as the EEC
estimates, the risk quotients range from < 0.1 to 0.6. Using the maximum
application rate for the granular formulation, which is 4 Ibs ai/acre, and
assuming no soil incorporation results in a risk quotient of 0.1 which is the
acute avian LOG for endangered birds.
At the present time EPA is working with the Fish and Wildlife Service
and other Federal and State agencies to develop a program to avoid jeopardizing
the continued existence of the identified species by the use of pesticides. When
this program goes into effect endangered species precautionary labeling will be
required.
8. Labeling Rationale
a. Compliance with Worker Protection Standard (WPS)
Any product whose labeling reasonably permits use in the
production of an agricultural plant on any farm, forest, nursery, or
greenhouse must comply with the labeling requirements of PR Notice
93-7, "Labeling Revisions Required by the Worker Protection Standard
(WPS)," and PR Notice 93-11, "Supplemental Guidance for PR Notice
93-7," which reflect the requirements of EPA's labeling regulations for
worker protection statements (40 CFR part 156, subpart K). These
labeling revisions are necessary to implement the WPS (40 CFR part
170) and must be completed in accordance with, and within the
deadlines specified in, PR Notices 93-7 and 93-11. Unless otherwise
specifically directed in this RED, all statements required by PR Notices
93-7 and 93-11 are to be on the product label exactly as instructed in
those notices.
After April 21, 1994, except as otherwise provided in PR
Notices 93-7 and 93-11, all products within the scope of those notices
must bear WPS PR Notice complying labeling when they are distributed
or sold by the primary registrant or any supplementally registered
distributor.
After October 23, 1995, except as otherwise provided in PR
Notices 93-7 and 93-11, all products within the scope of those notices
must bear WPS PR Notice complying labeling when they are distributed
or sold by any person.
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Post-Application Restrictions
WPS Entry Restrictions: Some registered uses of hexazinone are
within the scope of the WPS.
Restricted Entry Interval: Under the WPS, interim restricted entry
intervals (REI) for all uses within the scope of the WPS are based on the
acute toxicity of the active ingredient. The toxicity categories of the
active ingredient for acute dermal toxicity, eye irritation potential, and
skin irritation potential are used to determine the interim WPS REI. If
one or more of the three acute toxicity effects are in toxicity category I,
the interim WPS REI is established at 48 hours. If none of the acute
toxicity effects are in category I, but one or more of the three is
classified as category II, the interim WPS REI is established at 24 hours.
If none of the three acute toxicity effects are in category I or II, the
interim WPS REI is established at 12 hours. A 48-hour REI is increased
to 72 hours when an organophosphate pesticide is applied outdoors in
arid areas. In addition, the WPS specifically retains two types of REI's
established by the Agency prior to the promulgation of the WPS: (1)
product-specific REI's established on the basis of adequate data, and (2)
interim REI's that are longer than those that would be established under
the WPS.
For occupational end-use products containing hexazinone as an
active ingredient, the Agency is establishing a 48-hour REI for each
use of the product that is within the scope of the WPS. The basis for this
requirement is that hexazinone is categorized as toxicity category I
(severe) for eye irritation potential. The WPS REI in effect until now
was 24 hours. The Agency notes that the WPS places very specific
restrictions on entry during restricted-entry intervals when that entry
involves contact with treated surfaces and it believes that these existing
WPS protections are sufficient to mitigate post-application exposures of
workers who contact surfaces treated with hexazinone.
Early-Entry PPE: The WPS establishes very specific restrictions on
entry by workers to areas that remain under a REI if the entry involves
contact with treated surfaces. Among those restrictions are a prohibition
of routine entry to perform hand labor tasks and requirement that
personal protective equipment be worn. Personal protective equipment
requirements for persons who must enter areas that remain under a REI
are based on the toxicity concerns about the active ingredient. The
requirements are set in one of two ways:
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1. If EPA has no special concerns about the acute or other adverse
effects of an active ingredient, it establishes the early-entry PPE
requirements based on the acute dermal toxicity, skin irritation
potential, and eye irritation potential of the active ingredient.
2. If EPA has special concerns about an active ingredient due to
very high acute toxicity or to certain other adverse effects, such
as allergic effects, cancer, developmental toxicity, or
reproductive effects, it may establish early-entry PPE
requirements that are more stringent than would be established
otherwise.
Since hexazinone is classified as category IV for skin irritation
potential and for acute dermal toxicity and EPA has no special concerns
about other adverse effects, the PPE required for early entry is the
minimum early entry PPE permitted under the WPS: coveralls,
chemical-resistant gloves, shoes, and socks. Since hexazinone is
classified as category I for eye irritation potential, protective eyewear is
also required.
Non-WPS Entry Restrictions: Some registered uses of hexazinone are
outside the scope of the WPS. The Agency is establishing the following
entry restriction for all non-WPS occupational uses of hexazinone end-
use products (except pellet formulations): "Do not enter or allow others
to enter the treated area until sprays have dried." The basis for this
requirement is that hexazinone is categorized as toxicity category I
(severe) for eye irritation potential.
Personal Protective Equipment (PPE) Requirements
Handler PPE: For each end-use product, PPE requirements for
pesticide handlers will be set during reregistration in one of two ways:
1. If the Agency has no special concerns regarding other adverse
effects of an active ingredient, the PPE for pesticide handlers will be
established based on the acute toxicity of the end-use product. For
occupational-use products, PPE will be established using the process
described in PR Notice 93-7 or more recent EPA guidelines.
2. If the Agency has special concerns about an active ingredient due
to very high acute toxicity or certain adverse effects, such as allergic
effects or other effects (cancer, developmental toxicity, reproductive
effects, etc):
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• the Agency may establish in the RED minimum or "baseline"
handler PPE requirements for that active ingredient that pertain
to all or most occupational end-use products containing that
active ingredient.
• these minimum PPE requirements must be compared with the
PPE that would be designated on the basis of the acute toxicity of
each end-use product, and
• the more stringent choice for each type of PPE (i.e., bodywear,
hand protection, footwear, eyewear, etc.) must be placed on the
label of the end-use product.
There are no special toxicological concerns about hexazinone that
warrant the establishment of active-ingredient-based PPE requirements
for pesticide handlers.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregistration of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of hexazinone for the
above eligible uses has been reviewed and determined to be substantially
complete. The following generic data will be required on a confirmatory basis:
• 123-1 (a) Seed Germination/Seedling Emergence (cucumber, onion,
pea)
123-l(b) Vegetative Vigor (cucumber)
163-1 Leaching, Adsorption/Desorption
164-2 Aquatic Field Dissipation (not required if all aquatic uses
are removed from hexazinone product labels)
165-1 Confined Rotational Crops
166-1 Prospective Groundwater Monitoring Study
201-1 Droplet Size Spectrum
202-1 Drift Field Evaluation
171-4d Residue Analytical Method Ruminant
171-4e Storage Stability (Alfalfa, Metabolite C for Grass)
171-4j Magnitude of the Residue in Meat/Milk
171-4k Magnitude of the Residue in Grass Hay and Alfalfa Seed
Screenings
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2. Labeling Requirements for Manufacturing-Use Products
There are no labeling requirements for manufacturing-use products.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix
G, the Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria (Appendix F; Attachment E) and if not,
commit to conduct new studies. If a registrant believes that previously
submitted data meet current testing standards, then study MRID numbers should
be cited according to the instructions in the Requirement Status and Registrants
Response Form provided for each product.
2. Labeling Requirements for End-Use Products
Due to risk mitigation measures imposed, several label requirements
have been imposed. Please refer to section V(C) for details.
a. Worker Protection Standard (WPS)
The RED evaluation of the REI established by the WPS
concluded that the REI should be changed to 48 hours. The WPS REI
in effect until now was 24 hours. The Agency found no reason to retain
the 24-hour interim REI placed on hexazinone products by PR Notice
93-7. The new 48-hour REI must be inserted into the standardized REI
statement required by PR Notice 93-7.
The PPE for early entry under the 48-hour REI for hexazinone is
coveralls, chemical resistant gloves, shoes plus socks, and protective
eyewear. These PPE must be inserted into the early entry PPE
statement required by PR Notice 93-7.
b. Ground Water Labeling
• All product labels must carry the following advisory:
"This chemical is known to leach through soil into ground water
under certain conditions as a result of agricultural use. Use of
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this chemical in areas where soils are permeable, particularly
where the water table is shallow, may result in ground water
contamination."
c. Surface Water Labeling
• DuPont, the technical manufacturer of hexazinone, is in the
process of consolidating label language relating to surface and
ground water for all of their hexazinone products. After the
Agency has reviewed and approved these label amendments, all
hexazinone labels must carry this labeling.
3. Other Ground Water Requirements
• The Agency is requiring that registrants report any domestic
hexazinone ground water detections at any levels to the Agency.
• The Agency is requiring that duPont prepare a report of the ongoing
research in Maine in regard to ground water detections in blueberry use
areas and submit it to the Agency. This report must be submitted within
one year from receipt of this RED document. DuPont must do a one
year follow-up to the original report as well.
• The Agency is also requiring that duPont submit an analytical method or
immunoassay for detection of hexazinone in ground water. This must be
submitted within one year from receipt of this RED document.
• DuPont is required to submit educational materials that are currently
being developed to the Agency. These materials should be in specific
regard to product stewardship and address the potential of ground water
contamination from use of hexazinone. This information must be
submitted within one year from receipt of this RED document.
4. Risk To Non-Target Plants and Small Mammals
Due to the risk to non-target plants and small mammals, the following
mitigation step is required:
• Reduction of the maximum application rate from 13.5 Ib ai/acre to 8 Ib
ai/acre.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this Reregistration
Eligibility Decision (RED). Persons other than the registrant may generally distribute
or sell such products for 50 months from the date of the issuance of this RED.
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However, existing stocks time frames will be established case-by-case, depending on
the number of products involved, the number of label changes, and other factors. Refer
to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register,
Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell hexazinone
products bearing old labels/labeling for 26 months from the date of issuance of this
RED. Persons other than the registrant may distribute or sell such products for 50
months from the date of the issuance of this RED. Registrants and persons other than
registrants remain obligated to meet pre-existing Agency imposed label changes and
existing stocks requirements applicable to products they sell or distribute.
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VI. APPENDICES
61
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APPENDIX A. Table of Use Patterns
Subject to Reregistration
63
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APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment - Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
AGRICULTURAL RIGHTS -OF-WAY/FENCEROWS /HEDGEROWS
Spray., When needed., Boom sprayer. EC NA
EC NA
EC NA
SC/S NA
SC/S NA
SC/S NA
ALFALFA
Low volume spray (concentrate) ., Dormant., EC NA
Aircraft.
SC/S NA
Low volume spray (concentrate) ., Dormant., EC NA
Boom sprayer.
SC/S NA
Use Group
1.125 Ib A *
1.125 Ib A *
1.125 Ib A *
1.125 Ib A *
1.125 Ib A *
1.125 Ib A *
Use Group
1.5 Ib A *
1.35 Ib A F
1.35 Ib A M
1.35 Ib A C
1.5 Ib A *
1.35 Ib A F
1.35 Ib A M
1.35 Ib A C
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
@ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
/crop /year otherwise) /A] (days) Interv Codes
cycle /crop /year [day(s)]
cycle
: TERRESTRIAL FEED CROP
NS 1/1 yr NS NS NS NS FL
NS 1/1 yr NS NS NS NS LA
NS NS NS NS NS NS AL
NS 1/1 yr NS NS NS NS
NS 1/1 yr NS NS NS NS LA
NS 1/1 yr NS NS NS NS MS
: TERRESTRIAL FEED CROP
NS 1/1 yr NS NS NS NS
NS 1/1 yr NS NS NS NS
NS 1/1 yr NS NS NS NS
NS 1/1 yr NS NS NS NS
C46, G01(37) ,
G83 (37)
C46, G01(37) ,
G83 (37)
C46, G01(37) ,
G83 (37)
C46, G01(60) ,
H12 (60)
C46, G01(37) ,
G83 (37)
C46, G01(37) ,
G83 (37)
MT, SD, ND, WY C46, GDI (30),
G83 (30)
MT, ND, SD, WY C46, GDI (30),
G83 (30)
MT, SD, ND, WY C46, GDI (30),
G83 (30)
MT, ND, SD, WY C46, GDI (30),
G83 (30)
Low volume spray (concentrate)., Late
spring., Aircraft.
SC/S NA
1.5 Ib A
.9 Ib A
NS
NS
NS
NS NS
NS 001, 013
MT, SD, ND, WY C46, G01(30),
G83(30)
Geo.013: Northeastern and Midwestern states are the specific allowable geographic areas
for this application method. Late spring and between cuttings is the specific application
method timing.
NS
NS
NS
NS NS
NS 001, 013
MT, ND, SD, WY C46, GDI(30),
G83(30)
Geo.013: Northeastern and Midwestern states are the specific allowable geographic areas
for this application method.
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment - Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
ALFALFA (con't)
Low volume spray (concentrate) . , Late EC NA
spring., Boom sprayer.
Use Group
1.5 Ib A *
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
@ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
/crop /year otherwise) /A] (days) Interv Codes
cycle /crop /year [day(s)]
cycle
: TERRESTRIAL FEED CROP
NS NS
Geo.013:
for this
NS
Northeastern
( con ' t )
NS NS NS 001, 013 MT,
and Midwestern states are the specific
application method. Late spring and between cuttings
SD, ND, WY C46, GDI (30),
G83 (30)
allowable geographic areas
is the specific application
method timing.
SC/S NA
Low volume spray (concentrate) ., Seed crop., EC NA
Aircraft .
SC/S NA
Low volume spray (concentrate) ., Seed crop., EC NA
Boom sprayer.
SC/S NA
.9 Ib A *
1.5 Ib A *
1.35 Ib A F
1.35 Ib A M
1.35 Ib A C
1.5 Ib A *
1.35 Ib A F
1.35 Ib A M
1.35 Ib A C
NS NS
Geo.013:
for this
NS NS
NS NS
NS NS
NS NS
NS
Northeastern
NS NS NS 001, 013 MT,
and Midwestern states are the specific
ND, SD, WY C46, GDI (30),
G83 (30)
allowable geographic areas
application method.
NS
NS
NS
NS
NS NS NS CA MT,
NS NS NS CA MT,
NS NS NS CA MT,
NS NS NS CA MT,
SD, ND, WY C14, C46, GDI (30),
G83 (30)
ND, SD, WY C14, C46, GDI (30),
G83 (30)
SD, ND, WY C14, C46, GDI (30),
G83 (30)
ND, SD, WY C14, C46, GDI (30),
G83 (30)
Low volume spray (concentrate)., Spring.,
Aircraft.
SC/S NA
1.35 Ib A
Low volume spray (concentrate)., Spring.,
Boom sprayer.
* NS 1/1 yr
NS 1/1 yr
* NS 1/1 yr
CT, DE, IL, IN, MT,
IA, KY, ME, MD,
MA, MI, MN, MO,
NH, NJ, NY, OH,
PA, RI, VT, VA,
WV, WI
CT, DE, IL, IN, MT,
IA, KY, ME, MD,
MA, MI, MN, MO,
NH, NJ, NY, OH,
PA, RI, VT, VA,
WV, WI
CT, DE, IL, IN, MT,
IA, KY, ME, MD,
MA, MI, MN, MO,
NH, NJ, NY, OH,
PA, RI, VT, VA,
WV, WI
SD, ND, WY C46, GDI(30),
G83(30)
ND, SD, WY C46, GDI(30),
G83(30)
SD, ND, WY C46, GDI(30),
G83(30)
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)
cycle
Geographic Limitations
Allowed Disallowed
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
ALFALFA (con't)
SC/S NA
Low volume spray (concentrate)., Stubble.
Aircraft.
Use Group: TERRESTRIAL FEED CROP (con't)
1.35 Ib A * NS 1/1 yr NS NS NS
1.5 Ib A * NS 1/1 yr
SC/S NA
1.35 Ib A
Low volume spray (concentrate)., Stubble.
Boom sprayer.
SC/S NA
1.35 Ib A
Low volume spray (concentrate)., Winter.
Aircraft.
Low volume spray (concentrate)., Winter.
Boom sprayer.
SC/S NA
NS CT, DE, IL, IN, MT, ND, SD, WY C46, GDI(30),
IA, KY, ME, MD, G83 (30)
MA, MI, MN, MO,
NH, NJ, NY, OH,
PA, RI, VT, VA,
WV, WI
NS CT, DE, IL, IN, MT, SD, ND, WY C46, GDI(30),
IA, KY, ME, MD, G83 (30)
MA, MI, MN, MO,
NH, NJ, NY, OH,
PA, RI, VT, VA,
WV, WI
NS 1/1 yr
1.5 Ib A * NS 1/1 yr
NS 1/1 yr
1.5 Ib A * NS 1/1 yr
1.35 Ib A F NS 1/1 yr
1.35 Ib A M
1.35 Ib A C
1.5 Ib A
NS 1/1 yr
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS
NS
CT, DE, IL, IN, MT, ND, SD, WY C46, GDI(30),
IA, KY, ME, MD, G83 (30)
MA, MI, MN, MO,
NH, NJ, NY, OH,
PA, RI, VT, VA,
WV, WI
NS CT, DE, IL, IN, MT, SD, ND, WY C46, GDI(30),
IA, KY, ME, MD, G83 (30)
MA, MI, MN, MO,
NH, NJ, NY, OH,
PA, RI, VT, VA,
WV, WI
CT, DE, IL, IN, MT, ND, SD, WY C46, GDI(30),
IA, KY, ME, MD,
MA, MI, MN, MO,
NH, NJ, NY, OH,
PA, RI, VT, VA,
WV, WI
G83(30)
MT, SD, ND, WY C46, GDI(30),
G83(30)
MT, ND, SD, WY C46, GDI(30),
G83(30)
MT, SD, ND, WY C46, GDI(30),
G83(30)
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
ALFALFA (con't)
SC/S NA
Spray., Delayed dormant., Sprayer. EC NA
BLUEBERRY
Ground spray., Dormant., Boom sprayer. EC NA
GRASS FORAGE/FODDER/HAY
Spray., When needed., Boom sprayer. SC/S NA
PASTURES
Basal spray., When needed., Hand held EC NA
sprayer.
Spray., When needed., Boom sprayer. EC NA
EC NA
EC NA
SC/S NA
SC/S NA
Tree injection treatment., Summer., EC NA
Injection.
Tree injection treatment., Summer., Tree EC NA
injection equipment.
PINEAPPLE
Broadcast., Postharvest . , Sprayer. SC/S NA
Use Group: TERRESTRIAL FEED CROP (con't)
1.35 Ib A
1.35 Ib A
1.35 Ib A
1 Ib A
1 Ib A
.75 Ib A
F NS
M
C
F NS
M
C
1/1 yr NS NS NS NS
1/1 yr NS NS NS NS WY
MT, ND, SD, WY C46, GDI (30),
G83 (30)
C46
Use Group: TERRESTRIAL FOOD CROP
2 Ib A
* NS
NS NS NS NS NS NC
C46, HOl(SO)
Use Group: TERRESTRIAL FEED CROP
1.125 Ib A
* NS
1/1 yr NS NS NS NS
C46, G01(60) ,
H12 (60)
Use Group: TERRESTRIAL FEED CROP
.002114 Ib in. of
stem dia
1.125 Ib A
1.125 Ib A
1.125 Ib A
1.125 Ib A
1.125 Ib A
.001585 Ib ft.
interval
.001585 Ib ft.
interval
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS .66 Ib NS NS NS
1/1 yr NS NS NS NS AL
1/1 yr NS NS NS NS FL
1/1 yr NS NS NS NS LA
1/1 yr NS NS NS NS LA
1/1 yr NS NS NS NS MS
NS .66 Ib NS NS NS
NS .66 Ib NS NS NS
C46
C46, G01(37) ,
G83 (37)
C46, G01(37) ,
G83 (37)
C46, G01(37) ,
G83 (37)
C46, G01(37) ,
G83 (37)
C46, G01(37) ,
G83 (37)
C46
C46
Use Group: TERRESTRIAL FOOD+FEED CROP
1.8 Ib A
* NS
NS 5.4 Ib NS NS NS
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment - Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
PINEAPPLE (con't)
Broadcast., Postplant . , Sprayer.
Broadcast . , Preplant . , Aircraft .
Broadcast . , Preplant . , Sprayer.
Directed spray., Postemergence . , Boom
sprayer.
Directed spray., Postemergence., Knapsack
sprayer.
Spot treatment., When needed., Sprayer.
RANGELAND
Basal spray., Late winter., Hand held
sprayer.
Basal spray., Spring., Hand held sprayer.
Basal spray., When needed., Hand held
sprayer.
Spot soil treatment., Late winter., By hand.
Spot soil treatment., Spring., By hand.
Tree injection treatment., Summer.,
Injection.
Tree injection treatment., Summer., Tree
injection equipment.
SUGARCANE
Band treatment., Fall., Boom sprayer.
SC/S NA
SC/S NA
SC/S NA
SC/S NA
SC/S NA
SC/S NA
EC NA
EC NA
EC NA
EC NA
EC NA
P/T NA
P/T NA
EC NA
EC NA
SC/S NA
Use Group
1.8 Ib A *
1.8 Ib A *
1.8 Ib A *
1.8 Ib A *
1.8 Ib A *
3 . 6 Ib A *
Use Group
.002114 Ib in. *
DBH
.002114 Ib in. *
DBH
.002114 Ib in. *
DBH
.002114 Ib in. *
DBH
.002114 Ib in. of *
stem dia
.001984 Ib in. of *
stem dia
.001984 Ib in. of *
stem dia
.001585 Ib ft. *
interval
.001585 Ib ft. *
interval
Use Group
.9 Ib A F
.45 Ib A C
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
@ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
/crop /year otherwise) /A] (days) Interv Codes
cycle /crop /year [day(s)]
cycle
: TERRESTRIAL
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
: TERRESTRIAL
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
: TERRESTRIAL
NS 1/1 yr
FOOD+FEED CROP (con't)
5.4 Ib NS NS NS
5.4 Ib NS NS NS
5.4 Ib NS NS NS
5.4 Ib NS NS NS
5.4 Ib NS NS NS
5.4 Ib NS NS NS
FEED CROP
2 Ib NS NS NS TX
NS NS NS NS NM
2 Ib NS NS NS TX
NS NS NS NS NM
.66 Ib NS NS NS
NS .595 Ib NS NS
NS .595 Ib NS NS
.66 Ib NS NS NS
.66 Ib NS NS NS
FOOD+FEED CROP
NS 1.35 Ib NS NS LA
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46, GA4
-------
APPENDIX A - CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SUGARCANE (con't)
Band treatment., Spring., Boom sprayer.
Broadcast., Dormant., Boom sprayer.
Broadcast . , Early postemergence . , Boom
sprayer.
Broadcast., Fall., Boom sprayer.
Broadcast., Preemergence., Boom sprayer.
Broadcast., Spring., Boom sprayer.
Broadcast., Stubble., Boom sprayer.
Directed spray., Layby., Boom sprayer.
Directed spray., Postemergence., Boom
sprayer.
Low volume spray (concentrate) . ,
Postemergence., Boom sprayer.
Low volume spray (concentrate) . ,
Preemergence . , Aircraft .
Low volume spray (concentrate) . ,
Preemergence., Boom sprayer.
SC/S NA
SC/S NA
SC/S NA
SC/S NA
SC/S NA
SC/S NA
SC/S NA
SC/S NA
SC/S NA
SC/S NA
SC/S NA
SC/S NA
Use Group: TERRESTRIAL FOOD+FEED CROP (con't)
.9 Ib A F NS 1/1 yr NS 1.35 Ib NS NS LA
.45 Ib A C
.9 Ib A F NS 1/1 yr NS NS NS NS TX
.675 Ib A M
.45 Ib A
.9 Ib A
.675 Ib A
.45 Ib A
.9 Ib A
.45 Ib A
.9 Ib A
.675 Ib A
.45 Ib A
.9 Ib A
.45 Ib A
.9 Ib A
.675 Ib A
.45 Ib A
.9 Ib A
.675 Ib A
.45 Ib A
1.8 Ib A
.9 Ib A
3.6 Ib A
1.8 Ib A
.9 Ib A
3.6 Ib A
1.8 Ib A
.9 Ib A
3.6 Ib A
1.8 Ib A
.9 Ib A
C
F NS 1/1 yr NS NS NS NS TX
M
C
F NS 1/1 yr NS 1.35 Ib NS NS LA
C
F NS 1/1 yr NS NS NS NS TX
M
C
F NS 1/1 yr NS 1.35 Ib NS NS LA
C
F NS 1/1 yr NS NS NS NS TX
M
C
F NS 1/1 yr NS NS NS NS TX
M
C
O NS 1/1 yr NS NS NS NS FL
C
F NS 1/1 yr NS NS NS NS HI, PR
M
C
F NS 1/1 yr NS NS NS NS HI
M
C
F NS 1/1 yr NS NS NS NS FL, HI, PR
M
C
C46, GA4
C46, GA4
C46, GA4
C46, GA4
C46, GA4
C46, GA4
C46, GA4
C46, GA4
C46, GA4
C46, GA4
C46, GA4
C46, GA4
Spot treatment., When needed., Knapsack
sprayer.
SC/S NA
1.8 Ib A * NS 1/1 yr
NS NS NS HI, PR
C46, GA4
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED
AGRICULTURAL FALLOW/ IDLELAND
Bark cut treatment., April., Sprayer.
Bark cut treatment., February., Sprayer.
Bark cut treatment., June., Sprayer.
Bark cut treatment., March., Sprayer.
Bark cut treatment., May., Sprayer.
Basal spray., April., Hand held sprayer.
Basal spray., February., Hand held sprayer.
Basal spray., June., Hand held sprayer.
Basal spray., March., Hand held sprayer.
Basal spray., May., Hand held sprayer.
Broadcast., April., Aircraft.
Broadcast . , April . , Sprayer.
Broadcast., February., Aircraft.
Broadcast., February., Sprayer.
Broadcast . , June . , Aircraft .
Broadcast., June., Sprayer.
Broadcast., March., Aircraft.
Broadcast., March., Sprayer.
Broadcast . , May. , Aircraft .
Broadcast., May., Sprayer.
Soil treatment (specialized) ., April., Hand
-
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
Min. Appl .
Rate (AI un-
less noted
otherwise)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Max. Appl. Soil
Rate (AI Tex.
unless noted Max.
otherwise) Dose
Use Group
UC *
UC *
UC *
UC *
UC *
.002114 Ib in. *
DBH
.002114 Ib in. *
DBH
.002114 Ib in. *
DBH
.002114 Ib in. *
DBH
.002114 Ib in. *
DBH
6 Ib A *
6 Ib A *
6 Ib A *
6 Ib A *
6 Ib A *
6 Ib A *
6 Ib A *
6 Ib A *
6 Ib A *
6 Ib A *
6 Ib A *
Max. #
@ Max.
/crop
cycle
Apps
Rate
/year
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Max. Dose [ (AI
unless noted
otherwise) /A]
/crop /year
cycle
NON- FOOD CROP
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
Min.
Interv
(days)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr.
Entry
Interv
[day(s)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Geographic Limitations
Allowed Disallowed
]
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
Use
Limitations
Codes
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
held sprayer.
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
AGRICULTURAL FALLOW/ IDLELAND (con't)
Soil treatment (specialized) ., February., EC
Hand held sprayer.
Soil treatment (specialized) ., June., Hand EC
held sprayer.
Soil treatment (specialized) ., March., Hand EC
held sprayer.
Soil treatment (specialized) ., May., Hand EC
held sprayer.
Tree injection treatment., April., EC
Injection.
Tree injection treatment., April., Tree EC
injection equipment.
Tree injection treatment., February., EC
Injection.
Tree injection treatment., February., Tree EC
injection equipment.
Tree injection treatment., June., Injection. EC
Tree injection treatment., June., Tree EC
injection equipment.
Tree injection treatment., March., EC
Injection.
Tree injection treatment., March., Tree EC
injection equipment.
Tree injection treatment., May., Injection. EC
Tree injection treatment., May., Tree EC
injection equipment.
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group
NA 6 Ib A *
NA 6 Ib A *
NA 6 Ib A *
NA 6 Ib A *
NA 5.284E-04 Ib in. *
DBH
NA 5.284E-04 Ib in. *
DBH
NA 5.284E-04 Ib in. *
DBH
NA 5.284E-04 Ib in. *
DBH
NA 5.284E-04 Ib in. *
DBH
NA 5.284E-04 Ib in. *
DBH
NA 5.284E-04 Ib in. *
DBH
NA 5.284E-04 Ib in. *
DBH
NA 5.284E-04 Ib in. *
DBH
NA 5.284E-04 Ib in. *
DBH
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations
@ Max. Rate unless noted Interv Entry Allowed Disallowed
/crop /year otherwise) /A] (days) Interv
cycle /crop /year [day(s)]
cycle
: TERRESTRIAL NON- FOOD CROP (con't)
NS NS NS NS NS NS FL
NS NS NS NS NS NS FL
NS NS NS NS NS NS FL
NS NS NS NS NS NS FL
NS NS NS NS NS NS FL
NS NS NS NS NS NS FL
NS NS NS NS NS NS FL
NS NS NS NS NS NS FL
NS NS NS NS NS NS FL
NS NS NS NS NS NS FL
NS NS NS NS NS NS FL
NS NS NS NS NS NS FL
NS NS NS NS NS NS FL
NS NS NS NS NS NS FL
Use
Limitations
Codes
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
CHRISTMAS TREE PLANTATIONS
Use Group: TERRESTRIAL NON-FOOD CROP
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment - Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED ( con ' t )
CHRISTMAS TREE PLANTATIONS (con't)
Band treatment., Spring., Sprayer. EC NA
Use Group
2
1.75
1.25
Ib
Ib
Ib
A
A
A
F
M
C
Max. tt Apps Max. Dose [ (AI
@ Max. Rate unless noted
/crop /year otherwise) /A]
cycle /crop /year
cycle
: TERRESTRIAL NON-FOOD CROP
NS
Geo.
NS
.013: East
NS NS
of the Rocky
application method. Dosage
Min. Restr. Geographic Limitations
Interv Entry Allowed Disallowed
(days) Interv
[day(s) ]
(con' t)
NS NS 013 CT,
NH,
PA,
VA
DE, ME,
NJ, NY,
RI, TX,
, WV
MD,
NC,
VT,
Mountains is the specific allowable geographic
Use
Limitations
Codes
C46, G01(30)
area for this
is given at the broadcast rate; for band treatment, reduce
dosage proportionately.
SC/S NA
Broadcast., Fall., Aircraft. SC/S NA
1.8
1.575
1.125
1.8
Ib
Ib
Ib
Ib
A
A
A
A
F
M
C
*
NS
Geo.
NS
Geo .
NS
.013: See
NS
.013: West
NS NS
above
NS NS
of the Rocky
NS NS 013 CT,
NH,
PA,
VA
NS NS 013
DE, ME,
NJ, NY,
RI, TX,
, WV
MD,
NC,
VT,
Mountains is the specific allowable geographic
C46, GOK30)
C46, G01(30)
area for this
application method.
Broadcast. , Fall. , Sprayer. SC/S NA
Broadcast . , Spring. , Aircraft . SC/S NA
Broadcast. , Spring. , Sprayer. EC NA
SC/S NA
1.8
1.8
2
1.75
1.25
1.8
1.575
1.125
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
A
*
*
F
M
C
F
M
C
NS
Geo .
NS
Geo.
NS
NS
Geo .
NS
.013: See
NS
.013: See
NS
NS
.013: East
NS NS
above
NS NS
above
NS NS
NS NS
of the Rocky
NS NS 013
NS NS 013
NS NS CT,
NH,
PA,
VA
NS NS 013 CT,
NH,
PA,
VA
DE, ME,
NJ, NY,
RI, TX,
, WV
DE, ME,
NJ, NY,
RI, TX,
, WV
MD,
NC,
VT,
MD,
NC,
VT,
Mountains is the specific allowable geographic
application method. This application method may be used in areas west
Mountains with dosages of 2
Directed spray., Spring., Sprayer. EC NA
2
1.75
1.25
Ib
Ib
Ib
A
A
A
F
M
C
NS
NS
NS NS
pounds per acre in 20 gallons of
NS NS CT,
NH,
PA,
water.
DE, ME,
NJ, NY,
RI, TX,
C46, GOK30)
C46, G01(30)
C46, G01(30)
C46, G01(30)
area for this
of the Rocky
MD,
NC,
VT,
C46, GOK30)
VA, WV
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
CHRISTMAS TREE PLANTATIONS (don't)
Directed spray., When needed., Sprayer. SC/S NA
Spray., Fall., Aircraft. EC NA
Spray., Fall., Ground. EC NA
Spray., Spring., Aircraft. EC NA
Spray., Spring., Ground. EC NA
CONIFER RELEASE
Band treatment., Fall., Boom sprayer. EC NA
Use Group: TERRESTRIAL NON-FOOD CROP (con't)
1.8 Ib A F NS NS NS NS NS NS 013 CT, DE, ME, MD, C46, GDI (30)
1.575 Ib A M NH, NJ, NY, NC,
1.125 Ib A C PA, RI, TX, VT,
VA, WV
Geo.013: East of the Rocky Mountains is the specific allowable geographic area for this
application method. This application method may be used in areas west of the Rocky
Mountains with dosages of 2 pounds per acre in 20 gallons of water.
2 Ib A F NS NS NS NS NS NS 013 C46, GDI (30)
1.75 Ib A M Geo.013: West of the Rocky Mountains in snowbelt areas is the specific allowable
1.25 Ib A C geographic area for this application method.
2 Ib A F NS NS NS NS NS NS 013 C46, GDI (30)
1.75 Ib A M Geo.013: See above
1.25 Ib A C
2 Ib A F NS NS NS NS NS NS 013 C46, GDI (30)
1 . 75 Ib A M Geo.013: West of the Rocky Mountains is the specific allowable geographic area for this
1.25 Ib A C application method.
2 Ib A F NS NS NS NS NS NS 013 C46, GDI (30)
1.75 Ib A M Geo.013: See above
1.25 Ib A C
Use Group: FORESTRY
3 Ib A
2 Ib A
1.25 Ib A
F NS NS NS NS NS NS MT
M
C
C46
Band treatment., Fall., Ground. EC NA
SC/S NA
Band treatment., Late winter., Ground. EC NA
SC/S NA
NS NS NS NS NS NS 013 C46, GDI(30)
Geo.013: West of the Rocky Mountains in snowbelt areas is the specific allowable
geographic area for this application method. Dosage is given at the broadcast rate; for
band treatment, reduce dosage proportionately.
> . 7 Ib A
3 Ib A *
> . 7 Ib A
NS NS NS
Geo.013: See above
NS
NS
NS
013
C46, G01(30)
NS NS NS NS NS NS 013 C46, GDI(30)
Geo.013: West of the Rocky Mountains in rainbelt areas is the specific allowable
geographic area for this application method. Dosage is given at the broadcast rate; for
band treatment, reduce dosage proportionately.
NS NS NS
Geo.013: See above
NS
NS
NS
013
C46, G01(30)
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment - Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
CONIFER RELEASE (con't)
Band treatment., Postplant . , Ground.
Use Group
EC NA
3
Ib
A
*
Max. # Apps Max. Dose [ (AI
@ Max. Rate unless noted
/crop /year otherwise) /A]
cycle /crop /year
cycle
: FORESTRY
NS NS
Geo.013:
(con't)
NS NS
West of the Rocky
application method. Dosage
Min. Restr. Geographic Limitations Use
Interv Entry Allowed Disallowed Limitations
(days) Interv Codes
[day(s) ]
NS NS
Mountains is
013
C46,
GDI (30)
the specific allowable geographic area for this
is given at the broadcast rate; for
band treatment,
reduce
dosage proportionately.
Band treatment., Preplant . , Ground.
Band treatment., Spring., Boom sprayer.
Band treatment., Spring., Ground.
Basal spray., Early summer., Hand held
sprayer.
Basal spray., Late winter., Hand held
sprayer.
Basal spray., Preharvest . , Hand held
sprayer.
G NA
SC/S NA
EC NA
G NA
SC/S NA
EC NA
EC NA
SC/S NA
EC NA
EC NA
EC NA
2
2 .7
3
2
2.7
3
2
1.25
3
2.7
4
4
1.5
4
4
1.5
4
4
1.5
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
*
*
*
*
*
F
M
C
*
*
F
M
C
F
M
C
F
M
C
NS NS
Geo.013:
NS NS
Geo.013:
NS NS
Geo.013:
NS NS
Geo.013:
NS NS
Geo.013:
NS NS
NS NS
Geo.013:
allowable
rate; for
NS NS
Geo.013:
allowable
rate; for
NS NS
NS NS
NS NS
NS NS
See above
NS NS
See above
NS NS
See above
NS NS
See above
NS NS
See above
NS NS
NS NS
West of the Rocky
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
Mountains in
013
013
013
013
013
MT
013
rainbelt and snowbelt
geographic area for this application method. Dosage
band treatment, reduce dosage
NS NS
West of the Rocky
NS NS
Mountains in
proportionately.
013
rainbelt and snowbelt
geographic area for this application method. Dosage
band treatment, reduce dosage
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
proportionately.
GOK30)
C46,
C46,
GOK30)
GDI (30)
G01(30)
C46,
C46
C46,
G01(30)
G01(30)
areas is the specific
is given at the
C46,
broadcast
GOK30)
areas are the specific
is given at the
C46,
C46,
C46,
broadcast
GOK30)
GDI (30)
GDI (30)
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment - Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
Max. # Apps Max. Dose [ (AI
@ Max. Rate unless noted
/crop /year otherwise) /A]
cycle /crop /year
Min.
Interv
(days)
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
CONIFER RELEASE (con't)
Basal spray., When needed., Hand held EC NA
sprayer.
Broadcast., Early summer., Aircraft. P/T NA
Broadcast., Early summer., Ground. P/T NA
Broadcast., Fall., Aircraft. EC NA
Use Group
.002114 Ib
in. *
: FORESTRY (con
NS NS
't)
NS
NS
NS
NS
C46, G01(30)
DBH
3
2.5
1.5
3
2.5
1.5
3
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
F
M
C
F
M
C
*
NS NS
Geo.013: East
NS
of the
NS
Rocky
NS
Mountains
rainfall is the specific allowable
NS NS
Geo.013: See
NS NS
Geo.013: West
NS
above
NS
of the
NS
NS
Rocky
NS
NS
NS
013
in areas with greater than 20 inches of annual
geographic area for this site on label.
Mountains
geographic area for this application
EC NA
G NA
3
2
1.25
3
Ib
Ib
Ib
Ib
A
A
A
A
F
M
C
*
NS NS
NS NS
Geo.013: West
NS
NS
of the
geographic areas for
G NA
3
Ib
A
*
NS NS
Geo.013: West
NS
of the
NS
NS
Rocky
NS
NS
Mountains
NS
NS
in
013
013 C46, GDI (30)
snowbelt areas is the specific allowable
method .
NS
NS
and
MT C46
013 GDI (30)
east of the Cascades are the specific allowable
this application method.
NS
Rocky
NS
Mountains
NS
in
013 C46, G01(60) ,
H12 (60)
the Snowbelt region is the specific allowable
geographic area .
SC/S NA
2 .7
Ib
A
*
NS NS
Geo.013: West
NS
of the
NS
Rocky
NS
Mountains
geographic area for this application
Broadcast., Fall., Boom sprayer. EC NA
3
2
1.25
Ib
Ib
Ib
A
A
A
F
M
C
NS NS
NS
NS
NS
NS
in
013 C46, G01(30)
snowbelt areas is the specific allowable
method .
NS
MT C46
Broadcast., Fall., Granule applicator. G NA
Broadcast., Fall., Ground.
3 Ib A
3 Ib A
NS
NS
NS
NS
NS
NS
013
C46, G01(60),
H12(60)
Geo.013: West of the Rocky Mountains in the Snowbelt region is the specific allowable
geographic area. A backpack equipped with a granular applicator is the specific type of
application method equipment.
NS NS NS NS NS NS 013 C46, GDI(30)
Geo.013: West of the Rocky Mountains in snowbelt areas is the specific allowable
geographic area for this application method.
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application
Timing, Application Equipment
Form(s) Min. Appl.
Rate (AI un-
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
less noted
otherwise)
Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) Dose cycle /crop /year [day(s)]
cycle
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
CONIFER RELEASE (con't)
Broadcast., Late winter., Aircraft.
Broadcast., Late winter., Granule
applicator.
Broadcast., Late winter., Ground.
Broadcast., Postplant., Aircraft.
SC/S NA
SC/S NA
SC/S NA
Use Group: FORESTRY (con't)
3 Ib A
3 Ib A
> . 7 Ib A
NS NS NS NS NS NS 013 GDI (30)
Geo.013: West of the Rocky Mountains and east of the Cascades are the specific allowable
geographic areas for this application method.
NS NS NS NS NS NS 013 C46, GDI(30)
Geo.013: West of the Rocky Mountains in snowbelt areas is the specific allowable
geographic area for this application method.
NS NS NS NS NS NS 013 C46, GDI(30)
Geo.013: West of the Rocky Mountains in rainbelt areas is the specific allowable
geographic area for this application method.
NS NS NS
Geo.013: See above
NS NS NS
Geo.013: See above
NS
NS
NS
NS
NS
NS
NS
NS
NS
013
013
C46, G01(60),
H12(60)
C46, G01(30)
C46, G01(60),
H12(60)
Geo.013: West of the Rocky Mountains in the Rainbelt region is the specific allowable
geographic area. A backpack equipped with a granular applicator is the specific type of
application method equipment.
NS NS NS NS NS NS 013 C46, GDI(30)
Geo.013: West of the Rocky Mountains in rainbelt areas is the specific allowable
geographic area for this application method.
NS NS NS
Geo.013: See above
NS
NS
NS
013
C46, G01(30)
NS NS NS NS NS NS 013 C46, GDI(30)
Geo.013: West of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS NS
Geo.013: See above
NS
NS
NS
013
G01(30)
SC/S NA
Broadcast. , Postplant., Ground.
> . 7 Ib A * NS NS NS
Geo.013: See above
NS NS NS
Geo.013: See above
Ib A * NS NS NS
Geo.013: See above
C46, G01(30)
C46, G01(30)
G01(30)
-------
APPENDIX A - CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil
Timing, Application Equipment - Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
/crop /year otherwise)/A] (days) Interv Codes
cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
CONIFER RELEASE (con't)
Broadcast . , Posttransplant . , Aircraft .
Broadcast., Posttransplant., Ground.
Broadcast . , Preplant . , Aircraft .
Broadcast . , Preplant . , Ground.
Broadcast . , Pretransplant . , Aircraft .
SC/S NA
G NA
G NA
G NA
G NA
EC NA
G NA
G NA
SC/S NA
EC NA
G NA
SC/S NA
G NA
2 .7
1.25
1
.75
3
1.25
1
.75
3
3
4
3.5
3
2
2.7
3
2
2.7
1.25
1
.75
Use Group
Ib A *
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
F
M
C
*
F
M
C
*
*
F
M
C
*
*
*
*
*
F
M
C
: FORESTRY (con't)
NS NS NS
Geo.013: See above
NS NS NS
Geo.013: East of the
application method.
NS NS NS
Geo.013: West of the
application method.
NS NS NS
Geo.013: East of the
application method.
NS NS NS
Geo.013: West of the
application method.
NS NS NS
Geo.013: See above
NS NS NS
NS
NS
Rocky
NS
Rocky
NS
Rocky
NS
Rocky
NS
NS
Geo.013: East and west of
for this application method
pounds per acre.
NS NS NS
Geo.013: West of the
application method.
NS NS NS
Geo.013: See above
NS NS NS
Geo.013: See above
NS NS NS
Geo.013: See above
NS NS NS
Geo.013: See above
NS NS NS
Geo.013: East of the
application method.
NS
Rocky
NS
NS
NS
NS
NS
Rocky
NS NS
NS NS
Mountains is
NS NS
Mountains is
NS NS
Mountains is
NS NS
Mountains is
NS NS
NS NS
013
013
the specific
013
the specific
013
the specific
013
the specific
013
013
the Rocky Mountains is the
. Maximum dosage for areas
NS NS
Mountains is
NS NS
NS NS
NS NS
NS NS
NS NS
Mountains is
013
the specific
013
013
013
013
013
the specific
C46, G01(30)
G01(30)
allowable geographic area for
GOK30)
allowable geographic area for
GOK30)
allowable geographic area for
GOK30)
allowable geographic area for
this
this
this
this
C46, GOK30)
G01(30)
specific allowable geographic
west of the Rocky Mountains is
GOK30)
allowable geographic area for
area
20
this
C46, GOK30)
C46, G01(30)
G01(30)
C46, G01(30)
G01(30)
allowable geographic area for
this
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application
Timing, Application Equipment
Form(s) Min. Appl.
Rate (AI un-
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
less noted
otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) Dose cycle /crop /year [day(s)]
cycle
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
CONIFER RELEASE (con't)
Broadcast., Pretransplant., Ground.
Broadcast., Spring., Aircraft.
Use Group
3 Ib A *
1.25 Ib A F
1 Ib A M
.75 Ib A C
3 Ib A *
3 Ib A
3 Ib A F
2 Ib A M
1.25 Ib A C
FORESTRY (con't)
NS NS NS NS NS NS 013 GDI (30)
Geo.013: West of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS NS NS NS NS 013 GDI (30)
Geo.013: East of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS NS NS NS NS 013 GDI (30)
Geo.013: West of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS NS NS NS NS 013 C46, GDI(30)
Geo.013: West of the Rocky Mountains in rainbelt and snowbelt areas is the specific
allowable geographic area for this application method.
NS NS
NS NS NS NS MT
C46
3 Ib A F
2.2 Ib A M
1.5 Ib A C
G01(30)
Broadcast., Spring., Boom sprayer.
P/T NA
SC/S NA
3 Ib A F
2.25 Ib A M
1.5 Ib A C
3 Ib A F
2.25 Ib A M
1.5 Ib A C
3 Ib A F
2.5 Ib A M
1.5 Ib A C
2 . 7 Ib A *
3 Ib A F
2 Ib A M
1.25 Ib A C
NS NS NS NS NS NS 013 C46, GDI (60),
H12(60)
Geo.013: East of the Rocky Mountains in areas with greater than 20 inches of annual
rainfall are the specific allowable geographic areas for this application method. Product
may be applied at a rate of 4 pounds per acre west of the Rocky Mountains.
NS NS NS NS NS NS 013, 014 GDI(30)
Geo.013: East of the Rocky Mountains in areas with greater than 20 inches of annual
rainfall, and east and west of the Cascades are the specific allowable geographic areas for
this application method. Maximum dosage for east and west of the Cascades is 12 pounds per
acre.
NS NS NS NS NS NS 013
Geo.013: East of the Rocky Mountains in areas with greater than 20 inches of annual
rainfall is the specific allowable geographic area for this site on label.
NS NS NS NS NS NS 013 C46, GDI(30)
Geo.013: West of the Rocky Mountains in rainbelt and snowbelt areas are the specific
allowable geographic area for this application method.
NS
NS
NS
NS
NS
NS
MT
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment - Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
CONIFER RELEASE (con't)
Broadcast., Spring., Granule applicator. G NA
Use Group
3
2.25
1.5
Ib
Ib
Ib
A
A
A
F
M
C
Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
/crop /year otherwise) /A] (days) Interv Codes
cycle /crop /year [day(s) ]
cycle
: FORESTRY (con't)
NS NS NS NS NS NS 013 C46, 001(60),
H12 (60)
Geo.013: East of the Rocky Mountains in areas with greater than 20 inches of annual
rainfall are the specific allowable geographic areas for this application method. Product
may be applied at a rate of 4 pounds per acre west of the Rocky Mountains. A backpack
equipped with a granular applicator is the specific type of application method equipment.
Broadcast., Spring., Ground. EC NA
G NA
3
3
2.25
1.5
Ib
Ib
Ib
Ib
A
A
A
A
*
F
M
C
NS NS NS NS NS NS 013 C46, G01 (30)
Geo.013: West of the Rocky Mountains in rainbelt and snowbelt areas is the specific
allowable geographic area for this application method.
NS NS NS NS NS NS 013, 014 G01 (30)
Geo.013: East of the Rocky Mountains in areas with greater than 20 inches of annual
rainfall, and east and west of the Cascades are the specific allowable geographic areas
for
this application method. Maximum dosage for east and west of the Cascades is 12 pounds per
G NA
P/T NA
SC/S NA
Directed spray., Late winter., Ground. EC NA
Directed spray., Spring., Ground. EC NA
Ground spray., Early spring., Sprayer. SC/S NA
Ground spray., Early summer., Sprayer. SC/S NA
Ground spray., Late spring., Sprayer. SC/S NA
Soil treatment., Early summer., By hand. P/T NA
Soil treatment., Late winter., By hand. P/T NA
3
2 2
1.5
3
2.5
1.5
2.7
3
3
3.6
3.6
3.6
3.770
3.770
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
A
A
A
A
A
A
A
F
M
C
F
M
C
*
*
*
*
*
*
*
*
acre .
NS NS NS NS NS NS 014, 013 G01 (30)
Geo.013: East of the Rocky Mountains and east and west of the Cascades are the specific
allowable geographic areas for this application method.
NS NS NS NS NS NS 013
Geo.013: East of the Rocky Mountains in areas with greater than 20 inches of annual
rainfall is the specific allowable geographic area for this site on label.
NS NS NS NS NS NS 013 C46, G01 (30)
Geo.013: West of the Rocky Mountains in rainbelt and snowbelt areas are the specific
allowable geographic area for this application method.
NS NS NS NS NS NS 013 C46, G01 (30)
Geo.013: West of the Rocky Mountains in rainbelt areas is the specific allowable
geographic area for this application method.
NS NS NS NS NS NS 013 C46, G01 (30)
Geo.013: See above
NS NS NS NS NS NS 008 C46, G01 (30)
NS NS NS NS NS NS 008, 016 C46, G01 (30)
NS NS NS NS NS NS 016 C46, G01 (30)
NS NS NS NS NS NS G01 (30)
NS NS NS NS NS NS G01 (30)
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
CONIFER RELEASE (con't)
Spot soil treatment., Early summer., By
hand.
P/T
Spot soil treatment., Late winter., By hand. P/T
Spray., Early spring., Aircraft.
Spray., Early spring., Ground.
Spray., Early summer., Aircraft.
Spray., Early summer., Ground.
Spray., Late spring., Aircraft.
Spray., Late spring., Ground.
Tree injection treatment., Summer.,
Injection.
Tree injection treatment., Summer., Tree
injection equipment.
DRAINAGE SYSTEMS
Basal spray., Early summer., Hand held
sprayer.
Basal spray., Fall., Hand held sprayer.
Basal spray., Late winter., Hand held
sprayer.
EC
SC/S
EC
EC
SC/S
EC
EC
SC/S
EC
EC
EC
EC
RTU
EC
RTU
EC
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
.001984 Ib A *
.001984 Ib A *
4 Ib A *
3 . 6 Ib A *
4 Ib A *
4 Ib A *
3 . 6 Ib A *
4 Ib A *
4 Ib A *
3 . 6 Ib A *
4 Ib A *
1.321E-04 Ib in. *
interval
1.321E-04 Ib in. *
interval
Use Group
.002114 Ib in. of *
stem dia
3.000E-04 Ib *
sq.ft
.002114 Ib in. of *
stem dia
3.000E-04 Ib *
sq.ft
.002114 Ib in. of *
stem dia
Max. # Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: FORESTRY (con't)
NS NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: AQUATIC
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
NS
NS
NS 008
NS 008
NS 008
NS 008, 016
NS 008, 016
NS 008, 016
NS 016
NS 016
NS 016
NS
NS
GDI (30)
GDI (30)
C46,
C46,
C46,
C46,
C46,
C46,
C46,
C46,
C46,
C46,
C46,
G01(30)
G01(30)
G01(30)
G01(30)
GDI (30)
G01(30)
G01(30)
G01(30)
G01(30)
G01(30)
G01(30)
NON- FOOD INDUSTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46
C46
C46
C46
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
DRAINAGE SYSTEMS (con't)
Basal spray., Winter., Hand held sprayer.
Broadcast., Early summer., Aircraft.
Broadcast., Early summer., Ground.
Broadcast., Early summer., Sprayer.
Broadcast., Fall., Aircraft.
Broadcast . , Fall . , Ground.
Broadcast., Late winter., Aircraft.
Broadcast., Late winter., Ground.
Broadcast., Late winter., Sprayer.
Broadcast., Spring., Aircraft.
Broadcast., Spring., Ground.
Broadcast., When needed., Aircraft.
Broadcast., When needed., Boom sprayer.
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: AQUATIC NON-FOOD INDUSTRIAL
RTU
EC
RTU
G
P/T
G
P/T
SC/S
P/T
P/T
G
P/T
G
P/T
SC/S
P/T
P/T
G
P/T
RTU
SC/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
3.000E-04 Ib
sq.ft
.002114 Ib in. of
stem dia
3.000E-04 Ib
sq.ft
5 Ib A
8 Ib A
5 Ib A
8 Ib A
7.2 Ib A
8 Ib A
8 Ib A
5 Ib A
8 Ib A
5 Ib A
8 Ib A
7.2 Ib A
8 Ib A
8 Ib A
12 Ib A
12 Ib A
12.45 Ib A
1.125 Ib A
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1/1 yr
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS AL, AR, FL, GA,
LA, MS, OK, NC,
SC, TN, TX
C46
C46
C46
C46
C46
C46
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
DRAINAGE SYSTEMS (con't)
Broadcast., When needed., Ground.
Broadcast., When needed., Hand held sprayer.
Broadcast., When needed., Sprayer.
Broadcast., Winter., Aircraft.
Broadcast., Winter., Ground.
Directed spray., Early summer., Sprayer.
Directed spray., Fall., Sprayer.
Directed spray., Late winter., Sprayer.
Directed spray., When needed., Sprayer.
Directed spray., Winter., Sprayer.
Soil treatment (specialized) . , Early
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: AQUATIC NON-FOOD INDUSTRIAL
SC/S
EC
G
P/T
SC/S
EC
RTU
SC/S
SC/S
RTU
P/T
P/T
EC
RTU
EC
RTU
EC
RTU
SC/S
EC
RTU
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
13.5
12
12
12
10.8
12
12.45
10.8
13.5
12.45
8
8
8
8.3
8
8.3
8
8.3
13.5
8
8.3
12
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
(con' t)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS TX
NS
NS
NS
NS
NS
NS
NS
NS TX
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS TX
NS
NS
NS
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
summer., Hand held sprayer.
Soil treatment (specialized)., Late winter.
Hand held sprayer.
12 Ib A * NS
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment - Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
DRAINAGE SYSTEMS (con't)
Spot soil treatment., Early summer., By G NA
hand.
P/T NA
Spot soil treatment., Fall., By hand. P/T NA
Spot soil treatment., Late winter., By hand. G NA
P/T NA
Spot soil treatment., Spring., By hand. P/T NA
Spot soil treatment., Winter., By hand. P/T NA
Spray., When needed., Boom sprayer. SC/S NA
FOREST PLANTINGS (REFORESTATION PROGRAMS)
Band treatment., Fall., Boom sprayer. EC NA
Band treatment., Postplant . , Ground. EC NA
Use Group
.004688 Ib
.00475 Ib in.
.00475 Ib in.
.004688 Ib
.00475 Ib in.
.00475 Ib in.
.00475 Ib in.
1.125
in.
DBH
DBH
DBH
in.
DBH
DBH
DBH
DBH
Ib A
*
*
*
*
*
*
*
*
Use Group
3
2
1.25
3
Ib A
Ib A
Ib A
Ib A
F
M
C
*
Max. # Apps Max. Dose [ (AI
@ Max. Rate unless noted
/crop /year otherwise) /A]
cycle /crop /year
cycle
Min. Restr. Geographic Limitations Use
Interv Entry Allowed Disallowed Limitations
(days) Interv Codes
[day(s) ]
: AQUATIC NON-FOOD INDUSTRIAL (con't)
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS 1/1 yr
: FORESTRY
NS NS
NS NS
Geo.013: West
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
of the Rocky
application method.
Dosage
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS AL
NS MT
NS 013
Mountains is the specific
is given
at the broadcast
C46
C46
C46
allowable geographic area for this
rate; for band treatment, reduce
dosage proportionately.
G NA
Band treatment., Preplant . , Boom sprayer. EC NA
Band treatment., Preplant., Ground. EC NA
2
3
2
1.25
3
Ib A
Ib A
Ib A
Ib A
Ib A
*
F
M
C
*
NS NS
Geo.013: See
NS NS
NS NS
Geo.013: West
NS
above
NS
NS
NS
NS
NS
of the Rocky
application method.
Dosage
NS
NS
NS
NS 013
NS MT
NS 013
Mountains is the specific
is given
at the broadcast
GOK30)
C46
C46
allowable geographic area for this
rate; for band treatment, reduce
dosage proportionately.
G NA
Band treatment., Spring., Boom sprayer. EC NA
2
3
2
1.25
Ib A
Ib A
Ib A
Ib A
*
F
M
C
NS NS
Geo.013: See
NS NS
NS
above
NS
NS
NS
NS
NS
NS 013
NS MT
GOK30)
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment - Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
FOREST PLANTINGS (REFORESTATION PROGRAMS) (con't)
Basal spray., Early summer., Hand held EC NA
sprayer.
Basal spray., Late winter., Hand held EC NA
sprayer.
Basal spray., Preharvest . , Hand held EC NA
sprayer.
Basal spray., When needed., Hand held EC NA
sprayer.
Broadcast., Early summer., Aircraft. P/T NA
Broadcast., Early summer., Ground. P/T NA
Broadcast., Fall., Aircraft. EC NA
Use Group
6
6
3
6
6
3
6
6
3
.002114 Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
A
A
F
M
C
F
M
C
F
M
C
in. *
Max. # Apps Max. Dose [ (AI
@ Max. Rate unless noted
/crop /year otherwise) /A]
cycle /crop /year
cycle
: FORESTRY (con
NS
NS
NS
NS
NS
NS
NS
NS
't)
NS
NS
NS
NS
NS
NS
NS
NS
Min. Restr. Geographic Limitations Use
Interv Entry Allowed Disallowed Limitations
(days) Interv Codes
[day(s) ]
NS
NS
NS
NS
NS C46
NS C46
NS C46
NS C46
DBH
4
3
2
4
3
2
3
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
F
M
C
F
M
C
*
NS
Geo.
NS
013: East
NS
of the
NS
Rocky
NS
Mountains
NS 013
in areas with greater than 20 inches of annual
rainfall is the specific allowable geographic area for this site on label.
NS
Geo.
NS
Geo
NS
013: See
NS
.013: West
NS
above
NS
of the
NS
NS
Rocky
NS
NS
Mountains
geographic area for this application
EC NA
G NA
3
2
1.25
3
Ib
Ib
Ib
Ib
A
A
A
A
F
M
C
*
NS
NS
Geo
NS
NS
.013: West
NS
NS
of the
geographic areas for
G NA
3
Ib
A
*
NS
Geo
NS
.013: West
NS
of the
NS
NS
Rocky
NS
NS
Mountains
NS 013
NS 013 C46
in snowbelt areas is the specific allowable
method .
NS MT C46
NS 013 GDI (30)
and east of the Cascades are the specific allowable
this application method.
NS
Rocky
NS
Mountains
NS 013 C46, GDI (60) ,
H12 (60)
in the Snowbelt region is the specific allowable
geographic area .
Broadcast., Fall., Boom sprayer. EC NA
3
2
1.25
Ib
Ib
Ib
A
A
A
F
M
C
NS
NS
NS
NS
NS
NS MT C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application
Timing, Application Equipment
Form(s) Min. Appl.
Rate (AI un-
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
less noted
otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) Dose cycle /crop /year [day(s)]
cycle
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
FOREST PLANTINGS (REFORESTATION PROGRAMS) (con't)
Broadcast., Fall., Granule applicator. G NA
Broadcast., Fall., Ground.
Broadcast., Late winter., Aircraft.
Broadcast., Late winter., Granule
applicator.
Broadcast., Late winter., Ground.
Broadcast., Postplant., Aircraft.
Broadcast., Postplant., Ground.
Use Group: FORESTRY (con't)
3 Ib A
3 Ib A
3 Ib A
3 Ib A
3 Ib A
3 Ib A
3 Ib A
Ib A
3 Ib A
NS
NS
NS
NS
NS
NS
013
C46, G01(60),
H12(60)
Geo.013: West of the Rocky Mountains in the Snowbelt region is the specific allowable
geographic area. A backpack equipped with a granular applicator is the specific type of
application method equipment.
NS NS NS NS NS NS 013 C46
Geo.013: West of the Rocky Mountains in snowbelt areas is the specific allowable
geographic area for this application method.
NS NS NS NS NS NS 013 GDI (30)
Geo.013: West of the Rocky Mountains and east of the Cascades are the specific allowable
geographic areas for this application method.
NS NS NS NS NS NS 013 C46
Geo.013: West of the Rocky Mountains in rainbelt areas is the specific allowable
geographic area for this application method.
NS NS NS NS NS NS 013
Geo.013: See above
NS NS NS NS NS NS 013
C46, G01(60),
H12(60)
C46, G01(60),
H12(60)
Geo.013: West of the Rocky Mountains in the Rainbelt region is the specific allowable
geographic area. A backpack equipped with a granular applicator is the specific type of
application method equipment.
NS NS NS NS NS NS 013 C46
Geo.013: West of the Rocky Mountains in rainbelt areas is the specific allowable
geographic area for this application method.
NS NS NS NS NS NS 013 GDI (30)
Geo.013: West of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS NS
Geo.013: See above
NS
NS
NS
013
C46
Broadcast., Posttransplant., Aircraft. EC NA
3 Ib A
2 Ib A
1.25 Ib A
NS NS NS
Geo.013: See above
F NS
M
G01(30)
-------
APPENDIX A - CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment - Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
FOREST PLANTINGS (REFORESTATION PROGRAMS) (con't)
G NA
Broadcast., Posttransplant., Boom sprayer. EC NA
Broadcast., Posttransplant., Ground.
Broadcast., Preplant., Aircraft.
Use Group: FORESTRY (con't)
1.25 Ib A F
1 Ib A M
.75 Ib A C
3 Ib A *
3 Ib A F
2 Ib A M
1.25 Ib A C
1.25 Ib A F
1 Ib A M
.75 Ib A C
3 Ib A *
3 Ib A
NS NS NS NS NS NS 013 G01 (30)
Geo.013: East of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS NS NS NS NS 013 G01 (30)
Geo.013: West of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS
NS
NS NS
NS MT
C46
NS NS NS NS NS NS 013 G01 (30)
Geo.013: East of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS NS NS NS NS 013 G01 (30)
Geo.013: West of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS NS
Geo.013: See above
NS NS
NS 013
C46
3 Ib A F
2 Ib A M
1.25 Ib A C
Broadcast., Preplant., Boom sprayer.
Broadcast., Preplant., Ground.
4 Ib A F
3.5 Ib A M
3 Ib A C
2 Ib A
3 Ib A F
2 Ib A M
1.25 Ib A C
3 Ib A *
NS NS NS NS NS NS 013 GDI (30)
Geo.013: East and west of the Rocky Mountains is the specific allowable geographic area
for this application method. Maximum dosage for areas west of the Rocky Mountains is 20
pounds per acre.
NS NS NS NS NS NS 013 GDI (30)
Geo.013: West of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS
NS
NS NS
NS MT
C46
NS NS NS NS NS NS 013 C46
Geo.013: West of the Rocky Mountains is the specific allowable geographic area for this
application method.
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application
Timing, Application Equipment
Form(s) Min. Appl.
Rate (AI un-
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
less noted
otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) Dose cycle /crop /year [day(s)]
cycle
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
FOREST PLANTINGS (REFORESTATION PROGRAMS) (con't)
G NA
Broadcast., Pretransplant., Aircraft. G NA
Broadcast., Pretransplant., Ground.
Broadcast., Spring., Aircraft.
Use Group: FORESTRY (con't)
4 Ib A F
3.5 Ib A M
3 Ib A C
1.25 Ib A F
1 Ib A M
.75 Ib A C
3 Ib A *
1.25 Ib A F
1 Ib A M
.75 Ib A C
3 Ib A *
NS NS NS NS NS NS 013 GDI (30)
Geo.013: East and west of the Rocky Mountains is the specific allowable geographic area
for this application method. Maximum dosage for areas west of the Rocky Mountains is 20
pounds per acre.
NS NS NS NS NS NS 013 GDI (30)
Geo.013: West of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS NS NS NS NS 013 GDI (30)
Geo.013: East of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS NS NS NS NS 013 GDI (30)
Geo.013: West of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS NS NS NS NS 013 GDI (30)
Geo.013: East of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS NS NS NS NS 013 GDI (30)
Geo.013: West of the Rocky Mountains is the specific allowable geographic area for this
application method.
NS NS NS NS NS NS 013 C46
Geo.013: West of the Rocky Mountains in rainbelt areas is the specific allowable
geographic area for this application method.
3 Ib A F
2 Ib A M
1.25 Ib A C
NS NS
NS NS NS NS MT
C46
3 Ib A F
2.2 Ib A M
1.5 Ib A C
G01(30)
6 Ib A F NS NS NS NS NS NS 013 C46, G01(60),
3.998 Ib A M H12 (60)
3 Ib A C Geo.013: Areas east of the Rocky Mountains with greater than 20 inches of annual rainfall
are the specific allowable geographic areas on label. Product may be applied at a rate of 4
pounds per acre west of the Rocky Mountains.
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
FOREST PLANTINGS (REFORESTATION PROGRAMS) (con't)
G NA
P/T NA
Broadcast., Spring., Boom sprayer.
Use Group: FORESTRY (con't)
4.5 Ib A
4 Ib A
3 Ib A
4 Ib A
3 Ib A
2 Ib A
3 Ib A
2 Ib A
1.25 Ib A
F NS NS NS NS NS NS 013, 014 G01(30)
M Geo.013: East of the Rocky Mountains in areas with greater than 20 inches of annual
C rainfall, and east and west of the Cascades are the specific allowable geographic areas for
this application method. Maximum dosage for east and west of the Cascades is 12 pounds per
acre.
F NS NS NS NS NS NS 013
M Geo.013: East of the Rocky Mountains in areas with greater than 20 inches of annual
C rainfall is the specific allowable geographic area for this site on label.
NS
NS
NS
NS
NS
NS
MT
C46
Broadcast., Spring., Granule applicator. G NA
Broadcast., Spring., Ground.
6 Ib A F NS NS NS NS NS NS 013 C46, 001(60),
3.998 Ib A M H12 (60)
3 Ib A C Geo.013: East of the Rocky Mountains in areas with greater than 20 inches of annual
rainfall are the specific allowable geographic areas for this application method. Product
may be applied at a rate of 4 pounds per acre west of the Rocky Mountains. A backpack
equipped with a granular applicator is the specific type of application method equipment.
4.5 Ib A F NS NS NS NS NS NS 013, 014 G01 (30)
4 Ib A M Geo.013: East of the Rocky Mountains in areas with greater than 20 inches of annual
3 Ib A C rainfall, and east and west of the Cascades are the specific allowable geographic areas for
this application method. Maximum dosage for east and west of the Cascades is 12 pounds per
acre.
P/T NA
Directed spray., Late winter., Ground. EC NA
Directed spray., Spring., Ground.
Ground spray., Early summer., Boom sprayer. SC/S NA
3 Ib A F NS NS NS NS NS NS 014, 013 G01 (30)
2.2 Ib A M Geo.013: East of the Rocky Mountains and east and west of the Cascades are the specific
1.5 Ib A C allowable geographic areas for this application method.
4 Ib A F NS NS NS NS NS NS 013
3 Ib A M Geo.013: East of the Rocky Mountains in areas with greater than 20 inches of annual
2 Ib A C rainfall is the specific allowable geographic area for this site on label.
3 Ib A * NS NS NS NS NS NS 013 C46, G01(30)
Geo.013: West of the Rocky Mountains in rainbelt areas is the specific allowable
geographic area for this application method.
3 Ib A * NS NS NS NS NS NS 013 C46, G01(30)
Geo.013: West of the Rocky Mountains in rainbelt and snowbelt areas is the specific
allowable geographic area for this application method.
5.4 Ib A * NS NS NS NS NS NS 013 C46
Geo.013: East of the Rocky Mountains is the specific allowable geographic area for this
application method.
-------
APPENDIX A - CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
Min. Appl .
Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
-
less noted
otherwise)
FOREST PLANTINGS (REFORESTATION PROGRAMS) (con't)
Ground spray., Early summer., Sprayer.
SC/S
NA
unless noted Max.
otherwise) Dose
Use Group
5.4 Ib A *
Max. #
@ Max.
/crop
cycle
Apps Max. Dose [ (AI
Rate unless noted
/year otherwise) /A]
: FORESTRY
NS
NS
Geo.013:
Ground spray., Late spring., Boom sprayer.
SC/S
NA
5.4 Ib A *
NS
NS
Geo.013:
Ground spray., Late spring., Sprayer.
SC/S
NA
5.4 Ib A *
NS
NS
Geo.013:
Ground spray., When needed., Boom sprayer.
Ground spray., When needed., Sprayer.
Soil treatment., Early summer., By hand.
Soil treatment., Late winter., By hand.
Soil treatment., Preharvest . , By hand.
Spot soil treatment., Early summer., By
hand.
Spot soil treatment., Late winter., By hand.
Spot soil treatment., Preharvest., By hand.
Spray., Delayed dormant., Aircraft.
Spray., Delayed dormant., Boom sprayer.
Spray., Early summer., Aircraft.
SC/S
SC/S
P/T
P/T
P/T
P/T
P/T
P/T
EC
EC
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
5.4 Ib A *
5.4 Ib A *
5.754 Ib A *
5.754 Ib A *
5.754 Ib A *
001984 Ib in. of *
stem dia
001984 Ib in. of *
stem dia
001984 Ib in. of *
stem dia
6 Ib A *
6 Ib A *
6 Ib A *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
/crop /year
cycle
(con't)
NS NS
See above
NS NS
See above
NS NS
See above
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
Min. Restr. Geographic Limitations
Interv Entry Allowed Disallowed
(days) Interv
[day(s) ]
NS NS 013
NS NS 013
NS NS 013
NS NS ME, MI, MN, NH,
NY, VT, WI
NS NS ME, MI, MN, NH,
NY, VT, WI
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS ME, MI, MN, NH,
NY, VT, WI
NS NS ME, MI, MN, NH,
NY, VT, WI
NS NS 013
Use
Limitations
Codes
C46
C46
C46
C46
C46
G01(30)
G01(30)
G01(30)
G01(30)
G01(30)
GDI (30)
C46
C46
C46
Geo.013: East of the Rocky Mountains is the specific allowable geographic area for this
application method.
SC/S NA
5.4 Ib A
NS NS NS
Geo.013: See above
NS NS NS 013
Spray., Early summer., Boom sprayer.
6 Ib A *
NS NS NS
Geo.013: See above
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
FOREST PLANTINGS (REFORESTATION PROGRAMS) (con't)
Spray., Late spring., Aircraft. EC
SC/S
Spray., Late spring., Boom sprayer. EC
Spray., When needed., Aircraft. SC/S
Tree injection treatment., Summer., EC
Injection.
Tree injection treatment., Summer., Tree EC
injection equipment.
FOREST TREES (ALL OR UNSPECIFIED)
Soil treatment., Early summer., By hand. P/T
Soil treatment., Late winter., By hand. P/T
Spot soil treatment., Early summer., By P/T
hand.
Spot soil treatment., Late winter., By hand. P/T
Tree injection treatment., When needed., P/T
Tree injection equipment.
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES
Tree injection treatment., When needed., P/T
Tree injection equipment.
INDUSTRIAL AREAS (OUTDOOR)
Basal spray., Early summer., Hand held EC
sprayer.
RTU
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group
NA 6 Ib A *
NA 5.4 Ib A *
NA 6 Ib A *
NA 5.4 Ib A *
NA 1.321E-04 Ib in. *
interval
NA 1.321E-04 Ib in. *
interval
Use Group
NA 5.754 Ib A *
NA 5.754 Ib A *
NA .001984 Ib in. of *
stem dia
NA .001984 Ib in. of *
stem dia
NA UC *
Use Group
NA UC *
Use Group
NA .002114 Ib in. of *
stem dia
NA 3.000E-04 Ib *
sq.ft
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
@ Max. Rate unless noted Interv Entry Allowed
/crop /year otherwise) /A] (days) Interv
cycle /crop /year [day(s)]
cycle
: FORESTRY (con't)
NS NS NS NS NS NS 013
Geo.013: See above
NS NS NS NS NS NS 013
Geo.013: See above
NS NS NS NS NS NS 013
Geo.013: See above
NS NS NS NS NS NS ME, MI, MN, NH,
NY, VT, WI
NS NS NS NS NS NS
NS NS NS NS NS NS
: FORESTRY
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
: OUTDOOR RESIDENTIAL
NS NS NS NS NS NS
: TERRESTRIAL NON- FOOD CROP
NS NS NS NS NS NS
NS NS NS NS NS NS
Disallowed Limitations
Codes
C46
C46
C46
C46
C46
C46
G01(30)
G01(30)
G01(30)
G01(30)
C46
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
INDUSTRIAL AREAS (OUTDOOR) (con't)
Basal spray., Fall., Hand held sprayer.
Basal spray., Late winter., Hand held
sprayer.
Basal spray., When needed., Hand held
sprayer.
Basal spray., When needed., Power sprayer.
Basal spray., Winter., Hand held sprayer.
Broadcast., Early summer., Aircraft.
Broadcast., Early summer., Ground.
Broadcast., Early summer., Sprayer.
Broadcast., Fall., Aircraft.
Broadcast . , Fall . , Ground.
Broadcast., Late winter., Aircraft.
Broadcast., Late winter., Ground.
Broadcast., Late winter., Sprayer.
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: TERRESTRIAL
EC
RTU
EC
RTU
SC/S
SC/S
EC
RTU
G
P/T
G
P/T
SC/S
P/T
P/T
G
P/T
G
P/T
SC/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.002114 Ib in. of
stem dia
3.000E-04 Ib
sq.ft
.002114 Ib in. of
stem dia
3.113E-04 Ib
sq.ft
7.2 Ib A
7.2 Ib A
.002114 Ib in. of
stem dia
3.000E-04 Ib
sq.ft
5 Ib A
8 Ib A
5 Ib A
8 Ib A
7.2 Ib A
8 Ib A
8 Ib A
5 Ib A
8 Ib A
5 Ib A
8 Ib A
7.2 Ib A
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON- FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
CROP (con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS FL
NS FL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
INDUSTRIAL AREAS (OUTDOOR) (con't)
Broadcast., Not on label., By hand.
Broadcast., Spring., Aircraft.
Broadcast., Spring., Ground.
Broadcast., When needed., Aircraft.
Broadcast., When needed., Boom sprayer.
Broadcast., When needed., Granule
applicator.
Broadcast., When needed., Ground.
Broadcast., When needed., Hand held sprayer.
Broadcast., When needed., Sprayer.
Broadcast., Winter., Aircraft.
Broadcast., Winter., Ground.
Directed spray., Early summer., Sprayer.
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: TERRESTRIAL NON- FOOD
P/T
P/T
P/T
G
P/T
RTU
SC/S
SC/S
G
EC
G
P/T
SC/S
EC
RTU
SC/S
SC/S
RTU
P/T
P/T
EC
RTU
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
6.945
8
8
12
12
12.45
1.125
13.5
11.25
12
12
12
10.8
12
12.45
10.8
13.5
12.45
8
8
8
8.3
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
1/1 yr
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
CROP (con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS AL, AR, FL, GA,
LA, MS, OK, NC,
SC, TN, TX
NS TX
NS
NS
NS
NS
NS
NS
NS
NS
NS TX
NS
NS
NS
NS
NS
C46
C46
C46
C46, G01(60) ,
H12 (60)
C46
C46
C46
C46
C46
C46
C46
C46
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
INDUSTRIAL AREAS (OUTDOOR) (con't)
Directed spray., Fall., Sprayer.
Directed spray., Late winter., Sprayer.
Directed spray., When needed., Sprayer.
Directed spray., Winter., Sprayer.
Soil treatment (specialized) . , Early
summer., Hand held sprayer.
Soil treatment (specialized) ., Late winter.,
Hand held sprayer.
Spot soil treatment., Early summer., By
hand.
Spot soil treatment., Fall., By hand.
Spot soil treatment., Late winter., By hand.
Spot soil treatment., Not on label., By
hand.
Spot soil treatment., Spring., By hand.
Spot soil treatment., Winter., By hand.
Spray., When needed., Boom sprayer.
Tree injection treatment., When needed.,
Min. Appl .
Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
-
EC
RTU
EC
RTU
SC/S
EC
RTU
EC
EC
G
P/T
P/T
G
P/T
P/T
P/T
P/T
SC/S
P/T
less noted
otherwise)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
unless noted Max.
otherwise) Dose
Use Group
8 Ib A *
8.3 Ib A *
8 Ib A *
8.3 Ib A *
13.5 Ib A *
8 Ib A *
8.3 Ib A *
12 Ib A *
12 Ib A *
.004688 Ib in. *
DBH
00475 Ib in. DBH *
00475 Ib in. DBH *
.004688 Ib in. *
DBH
00475 Ib in. DBH *
001984 Ib in. of *
stem dia
00475 Ib in. DBH *
00475 Ib in. DBH *
1.125 Ib A *
UC *
Max. #
@ Max.
/crop
cycle
Apps
Rate
/year
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS 1/1 yr
NS
NS
Max. Dose
[(AI
unless noted
otherwise) /A]
/crop
cycle
NON- FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
/year
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Min.
Interv
(days)
(con' t)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations
Entry Allowed Disallowed
Interv
[day(s) ]
NS
NS
NS
NS
NS TX
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS AL
NS
Use
Limitations
Codes
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
Tree injection equipment.
NONAGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS
Use Group: TERRESTRIAL NON-FOOD CROP
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
NONAGRICULTURAL RIGHTS -OF-WAY/FENCEROWS/HEDGEROWS
Basal spray., Early summer., Hand held
sprayer.
Basal spray., Fall., Hand held sprayer.
Basal spray., Late winter., Hand held
sprayer.
Basal spray., When needed., Hand held
sprayer.
Basal spray., When needed., Power sprayer.
Basal spray., Winter., Hand held sprayer.
Broadcast., Early summer., Aircraft.
Broadcast., Early summer., Ground.
Broadcast., Early summer., Sprayer.
Broadcast., Fall., Aircraft.
Broadcast . , Fall . , Ground.
Broadcast., Late winter., Aircraft.
EC
RTU
EC
RTU
EC
RTU
SC/S
SC/S
EC
RTU
G
P/T
G
P/T
SC/S
P/T
P/T
G
P/T
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
(con't)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL
.002114 Ib in. of
stem dia
3.113E-04 Ib
sq.ft
.002114 Ib in. of
stem dia
3.000E-04 Ib
sq.ft
.002114 Ib in. of
stem dia
3.113E-04 Ib
sq.ft
7.2 Ib A
7.2 Ib A
.002114 Ib in. of
stem dia
3.000E-04 Ib
sq.ft
5 Ib A
8 Ib A
5 Ib A
8 Ib A
7.2 Ib A
8 Ib A
8 Ib A
5 Ib A
8 Ib A
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
CROP (con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS FL
NS FL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
NONAGRICULTURAL RIGHTS -OF-WAY/FENCEROWS/HEDGEROWS
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
applicator.
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Late winter., Ground.
Late winter., Sprayer.
Not on label., By hand.
Spring., Aircraft.
Spring., Ground.
When needed., Aircraft.
When needed., Boom sprayer.
When needed., Granule
When needed . , Ground .
When needed., Hand held sprayer.
When needed., Sprayer.
Winter., Aircraft.
G
P/T
SC/S
P/T
P/T
P/T
G
P/T
RTU
SC/S
SC/S
G
EC
G
P/T
SC/S
EC
RTU
SC/S
SC/S
RTU
P/T
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
(con't)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL NON- FOOD
5
8
7.2
6.945
8
8
12
12
12.45
1.125
13.5
11.25
12
12
12
10.8
12
12.45
10.8
13.5
12.45
8
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1/1 yr
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
CROP (con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS AL, AR, FL, GA,
LA, MS, OK, NC,
SC, TN, TX
NS TX
NS
NS
NS
NS
NS
NS
NS
NS
NS TX
NS
NS
C46
C46
C46
C46
C46, G01(60) ,
H12 (60)
C46
C46
C46
C46
C46
C46
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
Min. Appl .
Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
-
NONAGRICULTURAL RIGHTS -OF-WAY/FENCEROWS/HEDGEROWS
Broadcast., Winter., Ground.
Directed spray., Early summer., Sprayer.
Directed spray., Fall., Sprayer.
Directed spray., Late winter., Sprayer.
Directed spray., When needed., Sprayer.
Directed spray., Winter., Sprayer.
Soil treatment (specialized) . , Early
summer., Hand held sprayer.
Soil treatment (specialized) ., Late winter.,
Hand held sprayer.
Spot soil treatment., Early summer., By
hand.
Spot soil treatment., Fall., By hand.
Spot soil treatment., Late winter., By hand.
Spot soil treatment., Not on label., By
hand.
Spot soil treatment., Spring., By hand.
Spot soil treatment., Winter., By hand.
Spray., When needed., Boom sprayer.
P/T
EC
RTU
EC
RTU
EC
RTU
SC/S
EC
RTU
EC
EC
G
P/T
P/T
G
P/T
P/T
P/T
P/T
SC/S
less noted
otherwise)
(con't)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
unless noted Max.
otherwise) Dose
Use Group
8 Ib A *
8 Ib A *
8.3 Ib A *
8 Ib A *
8.3 Ib A *
8 Ib A *
8.3 Ib A *
13.5 Ib A *
8 Ib A *
8.3 Ib A *
12 Ib A *
12 Ib A *
.004688 Ib in. *
DBH
00475 Ib in. DBH *
00475 Ib in. DBH *
.004688 Ib in. *
DBH
00475 Ib in. DBH *
001984 Ib in. of *
stem dia
00475 Ib in. DBH *
00475 Ib in. DBH *
1.125 Ib A *
Max. #
@ Max.
/crop
cycle
Apps
Rate
/year
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS 1/1 yr
Max. Dose
[(AI
unless noted
otherwise) /A]
/crop
cycle
NON- FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
/year
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Min.
Interv
(days)
(con' t)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations
Entry Allowed Disallowed
Interv
[day(s) ]
NS
NS
NS
NS
NS
NS
NS
NS TX
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS AL
Use
Limitations
Codes
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
-
NONAGRICULTURAL RIGHTS -OF-WAY/FENCEROWS/HEDGEROWS
Tree injection treatment., When needed.,
Tree injection equipment.
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS
Bark cut treatment., April., Sprayer.
Bark cut treatment., February., Sprayer.
Bark cut treatment., June., Sprayer.
Bark cut treatment., March., Sprayer.
Bark cut treatment., May., Sprayer.
Basal spray., April., Hand held sprayer.
Basal spray., Early summer., Hand held
sprayer.
Basal spray., Fall., Hand held sprayer.
Basal spray., February., Hand held sprayer.
Basal spray., June., Hand held sprayer.
Basal spray., Late winter., Hand held
sprayer.
Basal spray., March., Hand held sprayer.
Basal spray., May., Hand held sprayer.
P/T
EC
EC
EC
EC
EC
EC
EC
RTU
EC
RTU
EC
EC
EC
RTU
EC
EC
Min. Appl .
Rate (AI un-
less noted
otherwise)
(con't)
NA
NA
NA
NA
NA
NA
NA
NA .00
NA
NA .00
NA
NA
NA
NA .00
NA
NA
NA
Max. Appl. Soil
Rate (AI Tex.
unless noted Max.
otherwise) Dose
Use Group
UC *
Use Group
UC *
UC *
UC *
UC *
UC *
.002114 Ib in. *
DBH
2114 Ib in. of *
stem dia
3.113E-04 Ib *
sq.ft
2114 Ib in. of *
stem dia
3.113E-04 Ib *
sq.ft
.002114 Ib in. *
DBH
.002114 Ib in. *
DBH
2114 Ib in. of *
stem dia
3.000E-04 Ib *
sq.ft
.002114 Ib in. *
DBH
.002114 Ib in. *
DBH
Max. #
@ Max.
/crop
cycle
Apps
Rate
/year
: TERRESTRIAL
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Max. Dose
[(AI
unless noted
otherwise) /A]
/crop
cycle
NON -FOOD
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
/year
CROP
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Min.
Interv
(days)
(con' t)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr.
Entry
Interv
[day(s)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Geographic Limitations
Allowed Disallowed
]
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
Use
Limitations
Codes
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS (con't)
Basal spray
sprayer.
Basal spray
Basal spray
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
Broadcast . ,
. , When needed., Hand held
. , When needed., Power sprayer.
. , Winter., Hand held sprayer.
April., Aircraft.
April., Sprayer.
Early summer., Aircraft.
Early summer., Ground.
Early summer., Sprayer.
Fall., Aircraft.
Fall . , Ground.
February., Aircraft.
February., Sprayer.
June., Aircraft.
June., Sprayer.
Late winter., Aircraft.
Late winter., Ground.
Late winter., Sprayer.
SC/S
SC/S
EC
RTU
EC
EC
G
P/T
G
P/T
SC/S
P/T
P/T
EC
EC
EC
EC
G
P/T
G
P/T
SC/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL
7.2 Ib A
7.2 Ib A
.002114 Ib in. of
stem dia
3.113E-04 Ib
sq.ft
6 Ib A
6 Ib A
5 Ib A
8 Ib A
5 Ib A
8 Ib A
7.2 Ib A
8 Ib A
8 Ib A
6 Ib A
6 Ib A
6 Ib A
6 Ib A
5 Ib A
8 Ib A
5 Ib A
8 Ib A
7.2 Ib A
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
CROP (con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS FL
NS FL
NS
NS
NS FL
NS FL
NS
NS
NS
NS
NS
NS
NS
NS FL
NS FL
NS FL
NS FL
NS
NS
NS
NS
NS
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS (con't)
Broadcast
Broadcast
Broadcast
Broadcast
Broadcast
Broadcast
Broadcast
Broadcast
Broadcast
Broadcast
Broadcast
Broadcast
Broadcast
Broadcast
Directed
., March., Aircraft.
., March., Sprayer.
., May., Aircraft.
., May., Sprayer.
., Not on label., By hand.
., Spring., Aircraft.
., Spring., Ground.
., When needed., Aircraft.
., When needed., Boom sprayer.
. , When needed . , Ground .
., When needed., Hand held sprayer.
., When needed., Sprayer.
., Winter., Aircraft.
., Winter., Ground.
spray., Early summer., Sprayer.
EC
EC
EC
EC
P/T
P/T
P/T
G
P/T
RTU
SC/S
EC
G
P/T
SC/S
EC
RTU
SC/S
RTU
P/T
P/T
EC
RTU
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
6
6
6
6
6.945
8
8
12
12
12.45
1.125
12
12
12
10.8
12
12.45
10.8
12.45
8
8
8
8.3
Use Group: TERRESTRIAL NON- FOOD
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1/1 yr
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
CROP (con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS FL
NS FL
NS FL
NS FL
NS
NS
NS
NS
NS
NS
NS AL, AR, FL, GA,
LA, MS, OK, NC,
SC, TN, TX
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS (con't)
Directed spray.
Directed spray.
Directed spray.
Soil treatment
held sprayer.
, Fall., Sprayer.
, Late winter., Sprayer.
, Winter., Sprayer.
(specialized) ., April., Hand
Soil treatment (specialized) . , Early
summer., Hand held sprayer.
Soil treatment (specialized) ., February.,
Hand held sprayer.
Soil treatment
held sprayer.
(specialized) ., June., Hand
Soil treatment (specialized) ., Late winter.,
Hand held sprayer.
Soil treatment
held sprayer.
Soil treatment
held sprayer.
(specialized) ., March., Hand
(specialized) ., May., Hand
Spot soil treatment., Early summer., By
EC
RTU
EC
RTU
EC
RTU
EC
EC
EC
EC
EC
EC
EC
G
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL
8 Ib A
8.3 Ib A
8 Ib A
8.3 Ib A
8 Ib A
8.3 Ib A
6 Ib A
12 Ib A
6 Ib A
6 Ib A
12 Ib A
6 Ib A
6 Ib A
.004688 Ib in.
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
CROP (con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS FL
NS
NS FL
NS FL
NS
NS FL
NS FL
NS
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
hand.
P/T
Spot soil treatment., Fall., By hand. P/T
Spot soil treatment., Late winter., By hand. G
P/T
Spot soil treatment., Not on label., By P/T
hand.
NA
NA
NA
NA
NA
DBH
.00475 Ib in. DBH * NS NS
.00475 Ib in. DBH * NS NS
.004688 Ib in. * NS NS
DBH
.00475 Ib in. DBH * NS NS
.001984 Ib in. of * NS NS
stem dia
NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
-------
APPENDIX A
CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS (con't)
Spot soil treatment., Spring., By hand. P/T
Spot soil treatment., Winter., By hand. P/T
Spray., When needed., Boom sprayer. SC/S
Tree injection treatment., April., EC
Injection.
Tree injection treatment., April., Tree EC
injection equipment.
Tree injection treatment., February., EC
Injection.
Tree injection treatment., February., Tree EC
injection equipment.
Tree injection treatment., June., Injection. EC
Tree injection treatment., June., Tree EC
injection equipment.
Tree injection treatment., March., EC
Injection.
Tree injection treatment., March., Tree EC
injection equipment.
Tree injection treatment., May., Injection. EC
Tree injection treatment., May., Tree EC
injection equipment.
RECREATIONAL AREAS
Tree injection treatment., When needed., P/T
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
00475 Ib in. DBH *
00475 Ib in. DBH *
1.125 Ib A *
5.284E-04 Ib in. *
DBH
5.284E-04 Ib in. *
DBH
5.284E-04 Ib in. *
DBH
5.284E-04 Ib in. *
DBH
5.284E-04 Ib in. *
DBH
5.284E-04 Ib in. *
DBH
5.284E-04 Ib in. *
DBH
5.284E-04 Ib in. *
DBH
5.284E-04 Ib in. *
DBH
5.284E-04 Ib in. *
DBH
Use Group
UC *
Max. #
@ Max.
/crop
cycle
Apps
Rate
/year
: TERRESTRIAL
NS
NS
NS
NS
NS 1/1 yr
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
Max. Dose [ (AI
unless noted
otherwise) /A]
/crop /year
cycle
NON- FOOD CROP
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NON- FOOD CROP
NS NS
Min.
Interv
(days)
(con' t)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr.
Entry
Interv
[day(s)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Geographic Limitations
Allowed Disallowed
]
AL
FL
FL
FL
FL
FL
FL
FL
FL
FL
FL
Use
Limitations
Codes
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
C46
Tree injection equipment.
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APPENDIX A - CASE 0266, [Hexazinone] Chemical 107201 [Hexazinone]
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps ® Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
EC : EMULSIFIABLE CONCENTRATE
G : GRANULAR
P/T : PELLETED/TABLETED
RTU : LIQUID-READY TO USE
SC/S : SOLUBLE CONCENTRATE/SOLID
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
C14 : Grown for seed only.
C46 : Do not apply through any type of irrigation system.
G01 : day(s) pregrazing interval.
GA4 : Do not feed treated forage to livestock.
HOI : day(s) preharvest interval.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES
001 : Northeast
008 : Southern States
013 : Other
014 : OR West of the Cascade Mountains
016 : Northern States
AL : Alabama
AR : Arkansas
CA : California
CT : Connecticut
DE : Delaware
FL : Florida
GA : Georgia
HI : Hawaii
IA : Iowa
IL : Illinois
IN : Indiana
KY : Kentucky
LA : Louisiana
MA : Massachussets
-------
MD : Maryland
ME : Maine
MI : Michigan
MN : Minnesota
MO : Missouri
MS : Mississippi
MT : Montana
NC : North Carolina
ND : North Dakota
NH : New Hampshire
NJ : New Jersey
NM : New Mexico
NY : New York
OH : Ohio
OK : Oklahoma
PA : Pennsylvania
PR : Puerto Rico
RI : Rhode Island
SC : South Carolina
SD : South Dakota
TN : Tennessee
TX : Texas
VA : Virginia
VT : Vermont
WI : Wisconsin
WV : West Virginia
WY : Wyoming
-------
APPENDIX B. Table of the Generic
Data Requirements and Studies Used to
Make the Reregistration Decision
105
-------
106
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Hexazinone covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Hexazinone in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
0 Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography\appendix for a complete citation of the study.
107
-------
108
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Hexazinone
REQUIREMENT
PRODUCT
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
CHEMISTRY
Chemical Identity
Starting Materials & Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
PH
Stability
USE
PATTERN
All
All
All
All
All
All
All
All
All
All
N/A
All
All
All
All
All
All
All
CITATION(S)
41172501, 42345701
41172501, 42345701
41172501, 42345701
41309001, 42345702
41309001, 42345702
41309001, 42345702
41203201
41203201
41203201
41203201,42292801
41203201,42292801
41203201, 42292801
41203201,42741801
41203201, 42292801
41203201,42292801
00118509, 41203201, 42292801
41203201,42292801
109
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Data Supporting Guideline Requirements for the Reregistration of Hexazinone
REQUIREMENT
USE
PATTERN
CITATION(S)
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Oxidizing/Reducing Action
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion characteristics
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
71-4A
71-4B
72-1A
72-1B
72-1C
72-1D
72-2A
72-2B
72-3A
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Bluegill - TEP
Fish Toxicity Rainbow Trout
Fish Toxicity Rainbow Trout- TEP
Invertebrate Toxicity
Invertebrate Toxicity - TEP
Estuarine/Marine Toxicity - Fish
All
N/A
All
All
N/A
N/A
All
A, B, C, J
A, B, C,J
A, B, C, J
A, B, C,J
A, B, C, J
A, B, C,J
J
A, B, C, J
J
A, B, C, J
J
A, B, C, J
41203201, 42292801
41203201, 42292801
41203201, 42292801
41203201, 42292801
00073988
00072663, 00107878
00104981
41764901, 41938001
41764902
00076959, 00104980
41235001
00104980
41235002
00116269
41235003
Waived
110
-------
Data Supporting Guideline Requirements for the Reregistration of Hexazinone
REQUIREMENT
USE
PATTERN
CITATION(S)
72-3B Estuarine/Marine Toxicity - Mollusk
72-3C Estuarine/Marine Toxicity - Shrimp
72-4A Early Life Stage Fish
72-4B Life Cycle Invertebrate
123-1A Seed Germination/Seedling Emergence
123-IB Vegetative Vigor
123-2 Aquatic Plant Growth
141-1 Honey Bee Acute Contact
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-1B
82-2
83-1B
83-2B
Acute Oral Toxicity - Rat
Acute Dermal Toxicity - Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21-Day Dermal - Rabbit/Rat
Chronic Toxicity - Non-Rodent
Oncogenicity - Mouse
A, B, C, J
A, B, C,J
A, B, C, J
A, B, C,J
A, B, C, J
A, B, C,J
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
00047164
00047164
41406001
00078041, 41406002
43162501
43162501
A, B, C,J 41287001, 43225101, 43225102, 43302701
A, B, C,J 41216502
41235004
00104974
41756701
00106003
00106004
41235005
00104977
00114484
41309005
42162301
00079203, 41359301, 42509301
111
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Data Supporting Guideline Requirements for the Reregistration of Hexazinone
REQUIREMENT
83-3A
83-3B
83-4
83-5
84-2A
84-2B
84-4
85-1
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Chronic Feeding/Carcinogenicity Rat
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
General Metabolism
USE
PATTERN
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
CITATION(S)
40397501
00028863
42066501
00108638
00098982, 00076956
00130709, 00131355
00130708
00247874
ENVIRONMENTAL FATE
161-1
161-2
161-3
162-1
162-3
162-4
163-1
164-1
164-2
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
Terrestrial Field Dissipation
Aquatic Field Dissipation
A, B, C,J
A, B, C, J
A, B
A, B, C, J
A, B
E
A, B, C, J
A, B, C
E
00064260, 41587301
41300801
41300802
41807401, 42635001
41807402, 42657301
41811801
00064262, 41528101 (DATA GAP; Due
4/3/95)
42377901, 42379201
DATA GAP (Waived if all aquatic uses
164-3
Forest Field Dissipation
are dropped)
00072664, 42336401
112
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Data Supporting Guideline Requirements for the Reregistration of Hexazinone
REQUIREMENT
USE
PATTERN
CITATION(S)
165-1
165-2
165-3
165-4
166-1
201-1
202-1
Confined Rotational Crop
Field Rotational Crop
Accumulation - Irrigated Crop
Bioaccumulation in Fish
Ground Water - Small Prospective
Droplet Size Spectrum
Drift Field Evaluation
RESIDUE CHEMISTRY
171-4A Nature of Residue - Plants
171-4B Nature of Residue - Livestock
171-4C Residue Analytical Method - Plants
171-4D Residue Analytical Method - Animal
171-4E Storage Stability
A, B 41008401, 42824001 (DATA GAP; Due
5/31/95)
A, B RESERVED
E RESERVED (Waived if all aquatic uses
are dropped)
A, B, C, J 00078032, 00064265
DATA GAP
DATA GAP; Due 12/31/94
DATA GAP; Due 12/31/94
00078047, 00104846, 00126127
00104843, 41524801, 42187901, 42219301
42248901, 42690601
00038868, 00101574, 00126127, 41572101
41572102, 41572103, 41572104, 41572105
41572106, 41964101, 41964102, 42987201
43025401
00038868, 00101574, 00126127, 41572101
41572102, 41572103, 41572104, 41572105
41572106, 41964101, 41964102, 43074201
42276001, 42322701, 42418001, 42423001
42492101, 42535601, 42867501 (DATA
GAP for Alfalfa and Metabolite C for
Grass)
113
-------
Data Supporting Guideline Requirements for the Reregistration of Hexazinone
REQUIREMENT
USE
PATTERN
CITATION(S)
171-4J Magnitude of Residues - Meat/Milk
171-4K Crop Field Trials
Berries Group
- Blueberries
Grass Forage, Fodder, and Hay Group
- Grasses, Pasture, and Rangeland
DATA GAP; Due 5/31/95
00101574, 41964101, 41964102
00138226, 41898301, 42419101(DATA
GAP for hay)
114
-------
Data Supporting Guideline Requirements for the Reregistration of Hexazinone
REQUIREMENT
USE
PATTERN
CITATION(S)
171-4L
Non-Grass Animal Feeds (forage, fodder,
straw, and hay) Group
- Alfalfa
Miscellaneous Commodities
- Pineapple
- Sugarcane
Processed Food
- Alfalfa
- Sugarcane
- Pineapple
00118050, 43074401, 43074402 (DATA
GAP for alfalfa seed screenings)
00126127, 42535601
00028733, 00114039, 42322701
Feed additive tolerance of 8.0 ppm
required for alfalfa meal
Feed additive tolerance required for
molasses
42276001, 42417901
Feed additive tolerance required for
pineapple processing residue
42492101
115
-------
116
-------
APPENDIX C. Citations Considered to
be Part of the Data Base Supporting the
Reregistration of Hexazinone
117
-------
118
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4 (d) (4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
119
-------
as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative position of the study within
the volume.
120
-------
BIBLIOGRAPHY
MRID
CITATION
00028733 E.I. du Pont de Nemours & Company (1976) Determination of Hexazinone
Metabolite C. Undated method. (Unpublished study received Jan 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 America, Inc., submitted by E.I. du Pont de Nemours
& Co., Wilmington, Del.; CDL:099298-A)
00038868 Holt, R.F. (1980) Determination 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 Eastern Oysters
( Crassostrea virginica ), to Grass Shrimp ( Palaemonetes pugio ), and to
Fiddler Crabs ( Uca pugila tor ). (Unpublished study received Jul 25, 1979
under 352378; prepared by EG&G Bionomics, submitted by E.I. du Pont de
Nemours & Co., Wilmington, Del.; CDL:099674-B)
00064260 Rhodes, R.C. (1974) Studies with Velpar Weed Killer in Water. (Unpublished
study received May 7, 1975 under 352-378; submitted by E.I. du Pont de
Nemours & Co., Wilmington, Del.; CDL: 110699-E)
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)
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)
121
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BIBLIOGRAPHY
MRID
CITATION
00072663 Dudeck, S.H.; Bristol, K.L. (1980) Avian Dietary Toxicity (LC50) Study in
Bobwhite Quail: Project No. 201-547. Final rept. (Unpublished 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.B.; et al. (1980) Movement of
Hexazinone in Forest Watersheds after a Hand Application of Velpar Gridball
Pellets for Site Preparation. Progress 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 International, Ltd., and
Washington College, submitted by E.I. du Pont de Nemours & Co.,
Wilmington, Del.; CDL:233989-A)
00076956 Krahn, D.F.; McCooey, K.T. (1981) Chinese Hamster Ovary Cell Assay for
Mutagenicity: Haskell Laboratory Report No. 56-81. (Unpublished study
received May 20, 1981 under 352-378; submitted by E.I. du Pont de Nemours
& Co., Wilmington, Del.; CDL:245117-A)
00076959 Schneider, P.W., Jr. (1976) 96-hour LC50 to Bluegill Sunfish: Haskell
Laboratory No. 408-76. (Unpublished study received May 20, 1981 under
352-378; submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.;
CDL:245117-D)
00078047 Rhodes, R.C. (1975) Letter sent to 324 File dated Aug 12, 1975: Uptake and
metabolism studies with 14C-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 Development Corp., submitted by E.I.
du Pont de Nemours & Co., Wilmington, Del.; CDL:245676-A; 245677)
122
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BIBLIOGRAPHY
MRID
CITATION
00101574 Interregional Research Project No. 4 (1982) Residue Studies of Hexazinone on
Blueberries and Methomyl on Sugarcane. (Compilation; unpublished study
received May 17, 1982 under 2E2687; CDL:070861-A)
00104846 Rapisarda, C. (19??) Metabolism of 14C-labeled Hexazinone in Alfalfa: Doc.
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42423001 Klemens, A.; Devine, P. (1992) Freezer Storage Stability of Velpar Herbicide
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Metabolism of (carbon 14)-Hexazinone: Supplement 1: Analysis of 2 Additional
Non-Sterile Anaerobic Water-Sediment Systems after 365 Days Incubation and
Structural Assignment of Metabolite 2: Lab Project Number: HRC/DPT
193/901475: AMR-1328-88. Unpublished study prepared by Huntingdon
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Alfalfa Forage, Hay, and Seed Grown in the Western United States Following
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134
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APPENDIX D. List of Available Related Documents
135
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136
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The following is a list of available documents related to Hexazinone. It's purpose is to
provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for Hexazinone and are included in the EPA's Office of
Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Hexazinone RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
137
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138
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APPENDIX E. PR Notices 86-5 and 91-2
139
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140
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PR Notice 86-5
141
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142
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I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
/""Pno1t° WASHINGTON, B.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Pers9ns responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and certain provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining
pesticide registrations, experimental use permits, tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA. These data are defined in FIFRA §10(d)(1). This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
Ill. Effective Date
This notice is effective on November 1, 1986. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the
submitter for necessary revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in
the Federal Register (49 FR 37956) which include Requirements for
Data Submission (40 CFR §158.32), and Procedures for Claims of
Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
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entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.
V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be C9mpatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen is to avoid the additional C9sts and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of applicati9n
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
deadlines for inserting int9 the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each application
for registration or other action include a list 9f all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support f9r the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party. That requirement is not altered by this notice, which
applies only to data submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements
foll9ws the index on the next page, and samples of some of the
requirements are attached. Except for the language 9f the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies . . 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
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D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10 (d) (1)1 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(1) ) 8 14
D. 5 Good Laboratory Practice Compliance Statement . . 9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies .... 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at
the same time f9r review in support of a single regulatory
action, along with a transmittal document and other related
administrative material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this Notice. The transmittal and any other admin-
istrative material must be gr9uped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims).
B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--!.e., a registration application,
petition, experimental use permit (EUPT, §3 (c) (2) (B) data
call-in, §6(a)(2) submittal, or a special review; the transmittal
date; and a list of all individual studies included in the
gackage in the order of their appearance, showing (usually by
uideline reference number) the data requirement(s) addressed by
each one. The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
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application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40 CFR 180.7
and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petiti9n and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
C9nventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with 39016 exceptions dis-
cussed in section C.I. Each study included in a submittal
Eackage must be bound as a separate entity. (See comments on
inding studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study on
each page (i.e., 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or mark and study number on each
page of the study, e g , Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
When a single study is extremely long, binding it in mul-
tiple V9lumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.1 Special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical C9ntrol data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
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produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61, 62, and 63) for
C9nventional pesticides, or for the equivalent subject range for
biorational pesticides. The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
second W9uld cover Guidelines 151-23 and 151-25; the third would
cover Guideline 151-26.
Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
§10(d)(1)(A), (B) , or (C), and if so must be handled as described
in section D.3. of this notice.
c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
h9wever, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from processing a
single crop. When more than one commodity is derived from a
single crop (such as beet tops and beet roots) residue data on
all such C9mmodities should be reported as a single study. When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports Iaborat9ry Page 16
work subject to GLP require-
ments
For certain t9xicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C)
CBI Attachment
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C) Page 15
Supplemental Statement Only if confidentiality is Page 14
of Data Confidentiality claimed on a basis other than
Claims FIFRA §10(d)(1)(A), (B), or (C)
147
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D.I. Title Page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study title. The study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears in
the Guidelines.
b. Data requirement addressed. Include on the title page the
Guideline number(s) of the specific requirement(s) addressed by
the study.
c. Author(s). Cite only individuals with primary intellectual
responsibility for the C9ntent 9f the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory IdentificatJ9n. If the study reports
work done by one or more laboratories,Include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include 9n the title page elements a. through d. for the
previ9usly submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers. (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary study. Do not include supplements to more than one
study under a single title page).
g. Facts of Publication. If the study is a reprint of a pub-
lished d9cument, identity on the title page all relevant facts of
publication, such as the J9urnal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d) (1) .
Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 (b) and (c) (See
Attachment 3). These statements apply only to claims of data
confidentiality based on FIFRA §10(d)(1)(A), (B), or (C). Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or
to waive such a claim (§158.33(c)). In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. 09 not make CBI
claims with respect to analytical methods associated with pet-
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itions for tolerances or emergency exemptions (see NOTE Pg 13).
D.3. Confidential Attachment
If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
§10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body 9f the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5).
The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment." An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet. Paginate the Confidential Attachment
separately from the body of the study, beginning with page 1 of X
on the title page. Each passage confined t9 the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
§10(d)(1) on which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §10(d)
(1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement 9f Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us t9 retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies smpuld not be included in the transmit-
tal document, but should be incorp9rated into the statement of
the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed 9n one side only in
black ink, with high contrast and good res9lution. Bindings for
individual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
149
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instructions bef9re submitting data in any medium other than
paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than
black ink.
• Make sure that photocopies are clear, complete, and
fully readable.
• Do not include oversize computer printouts or fold-out
pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence.
Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The prop9sed regulati9ns specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Stan-
dard 9r Special Review must be provided in four C9pies, fr9m one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data
Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d)(1)(A), (B), or (C). Do not
close up or paraphrase text remaining after this
excision.
• Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential".
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V. For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality
Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample G9od Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
"Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
"Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is
submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g. experimental
use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline
No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-
smittal letter. This remains an acceptable practice so
long as all four elements are included.
* Indicate which of the J9int submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data.
Company Official:
Name Signature
Company Name
Company Contact:
Name Phone
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(1)(A),(B), or (C).
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this
study on the basis of its falling within the scope of FIFRA
6§10(d)(1)(A), (B), or (C).
Company
Company Agent: Typed Name Date:
Title Signature
2. Claim of confidentiality under FIFRA §10(d)(1)(A), (B), or (C).
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent: Typed Name Date:
Title Signature
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method. These
analytical methods are published in the FDA Pesticide Analytical
Meth9ds Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1)(A), (B), or (C), but for which y9u claim
C9nfidential treatment 9n another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
• Identify specifically by page and line number(s) each
portion of the study for which you claim
confidentiality.
• Cite the reasons why the cited passage qualifies for
confidential treatment.
• Indicate the length of time--until a specific date or
event, or permanently--for which the information should
be treated as confidential.
• Identify the measures taken to guard against undesired
disclosure of this information.
• Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
• Encl9se C9pies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
• If y9u assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe th9se harmful effects and explain why
they should be viewed as substantial.
• If you assert that the informati9n in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the following
paragraph(s) at the indicated volume and page references.
DELETED WORDS OR PHRASE: Ethylene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
100 19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study in place of the following
paragraph(s) at the indicated volume and page references.
DELETED PARAGRAPH (S):
( )
( Reproduce the deleted paragraph (s) here )
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process §10(d)(l)(C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the following
paragraph(s) at the indicated volume and page references.
DELETED PAGES (S): are attached immediately behind this page
PAGES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process §10(d)(l)(A)
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1.
2.
3.
Submitter
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
• Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims
When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
LEGEND
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PR Notice 91-2
159
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160
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Program's P9licy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CFR 158.153(1). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
9f identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting go9d manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175 (c) (3) .
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
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product compositi9n because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is imp9rtant for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal C9ncentrati9n expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. C9pies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to pr9vide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i. e., upper limit(s) 9nly) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to C9ntrol pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
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(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
(3) All other products/applications that are not subject to
(1) and (2) ab9ve will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
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APPENDIX F. Combined Generic and Product Specific
Data Call-In
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GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status
Sheet, to submit certain data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you
must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 7; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3 (for both generic and product specific data), the Requirements
Status and Registrant's Response Form, (see section III-B); or
3. Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-in Response Forms. Also included is a list of all
registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No.
2070-0107 and 2070-0057 (expiration date 3-31-96).
This Notice is divided into six sections and seven Attachments. The Notice itself
contains information and instructions applicable to all Data Call-In Notices. The Attachments
contain specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You are Receiving this Notice
Section II - Data Required by this Notice
Section III - Compliance with Requirements of this Notice
Section IV - Consequences of Failure to Comply with this Notice
Section V - Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Section VI - Inquiries and Responses to this Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
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2 - Generic Data Call-in and Product Specific Data Call-in Response Forms with
Instructions
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions
4 - LPA Grouping or End-Use Products for Meeting Acute Toxicology Data
Requirements tor Reregistration
5 - LPA Acceptance Criteria
6 - List or Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because
you have product(s) containing the subject active ingredients.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and
Registrant's Response Forms: Attachment 3 (for both generic and product specific data
requirements). Depending on the results of the studies required in this Notice, additional
studies/testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified
in the Requirements Status and Registrant's Response Forms (Attachment 3) within the
timeframes provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:
703-487-4650).
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 (40 CFR § 158.70). When using the
C"ECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001 L
Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160].
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II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED
BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of any previous Data Call-in (s), or any other agreements entered into
with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected
products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to this
Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is
specified in item number 3 on the four Data Call-in forms (Attachments 2 and 3).
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for generic and product
specific data must be submitted to the Agency within 90 days after your receipt of this Notice.
Failure to adequately respond to this Notice within 90 days of your receipt will be a basis for
issuing a Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for
issuance of NOIS due to failure to comply with this Notice are presented in Section IV-A and
IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
1. Generic Data Requirements
The options for responding to this Notice for generic data requirements are: (a)
voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy
the generic data requirements imposed by this Notice or (e) request a data waiver (s).
A discussion of how to respond if you choose the Voluntary Cancellation option, the
Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion
of the various options available for satisfying the generic data requirements of this Notice is
contained in Section III-C. A discussion of options relating to requests for data waivers is
contained in Section III-D.
Two forms apply to generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response. These two forms are the
Data-CalHn Response Form, and the Requirements Status and Registrant's Response Form,
(contained in Attachments Z and 3, respectively).
The Data Call-In Response Forms must be submitted as part of every response to this
Notice. The Requirements Status and Registrant's Response Forms also must be submitted if
you do not qualify for a Generic Data Exemption or are not requesting voluntary cancellation
of your registration^). Please note that the company's authorized representative is required to
sign the first page of both Data Call-in Response Forms and the Requirements Status and
Registrant's Response Forms (if this form is required) and initial any subsequent pages. The
forms contain separate detailed instructions on the response options. Do not alter the printed
material. If you have questions or need assistance in preparing your response, call or write the
contact person (s) identified in Attachment 1.
a. Voluntary Cancellation -
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit completed Generic and Product Specific
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Data Call-in Response Forms (Attachment 2), indicating your election of this option.
Voluntary cancellation is item number 5 on both Data Call-In Response Form(s). If you
choose this option, these are the only forms that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
b. Use Deletion -
You may avoid the requirements of this Notice by eliminating the uses of your product
to which the requirements apply. If you wish to amend your registration to delete uses, you
must submit the Requirements Status and Registrant's Response Form (Attachment 3), a
completed application tor amendment, a copy of your proposed amended labeling, and all
other information required for processing the application. Use deletion is option number 7
under item 9 in the instructions for the Requirements Status and Registrant's Response Forms.
You must also complete a Data Call-In Response Form by signing the certification, item
number 8. Application forms tor amending registrations may be obtained from the
Registration Support Branch, Registration Division, Office of Pesticide Programs, EPA, by
calling (703) ~~-~
If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due
date of your 90 day response, is allowed only if the product bears an amended label.
c. Generic Data Exemption -
Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is
exempt from the requirement to submit or cite generic data concerning an active ingredient if
the active ingredient in the product is derived exclusively from purchased, registered pesticide
products containing the active ingredient. EPA has concluded, as an exercise of its discretion,
that it normally will not suspend the registration of a product which would qualify and
continue to qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify,
all of the following requirements must be met:
(i). The active ingredient in your registered product must be present solely because of
incorporation of another registered product which contains the subject active ingredient
and is purchased from a source not connected with you;
(ii). Every registrant who is the ultimate source of the active ingredient in your
product subject to this DCI must be in compliance with the requirements of this Notice
and must remain in compliance; and
(iii). You must have provided to EPA an accurate and current " Confidential Statement
of Formula" for each of your products to which this Notice applies.
To apply for the Generic Data Exemption you must submit a completed Data Call-in
Response Form, Attachment 2 and all supporting documentation. The Generic Data Exemption
is item number 6a on the Data Call-in Response Form. If you claim a generic data exemption
you are not required to complete the Requirements Status and Registrant's Response Form.
Generic Data Exemption cannot be selected as an option for responding to product specific
data requirements.
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 registrant^) who have committed to
generate and submit the required data fail to take appropriate steps to meet requirements or are
no longer in compliance with this Data Call-In Notice, the Agency will consider that both they
and you are not compliance and will normally initiate proceedings to suspend the registrations
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of both your and their product(s), unless you commit to submit and do submit the required
data within the specified time. In such cases the Agency generally will not grant a time
extension for submitting the data.
d. Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this
Notice. These options are discussed in Section III-C.l. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
Form and item 6b on the Data Call-in Response Form, it you choose item 6b (agree to satisfy
the generic data requirements), you must submit the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form as weii as any other information/data
pertaining to the option chosen to address the data requirement. Your response must be on the
forms marked "GENERIC" in item number 3.
e. Request for Generic Data Waivers.
Waivers for generic data are discussed in Section III-D.l. of this Notice and are
covered by options 8 and 9 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.
2. Product Specific Data Requirements
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this Notice
or (c) request a data waiver (s).
A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section III-C.2. A discussion of
options relating to requests for data waivers is contained in Section III-D.2.
Two forms apply to the product specific data requirements one or both of which must
be used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form,
for product specific data (contained in Attachments 2 and 3, respectively). 1 he Data CallTn
Response Form must be submitted as part of every response to this Notice. In addition, one
copy of the Requirements Status and Registrant's "Response Form also must be submitted for
each product listed on the Data Caii-ln Response Form uniess the voluntary cancellation option
is selected. Please note that the company's authorized representative is required to sign the
first page of the Data Call-In Response Form and Requirements Status and Registrant s
Response Form (if this form is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or write the contact
person (s) identified in Attachment 1.
a. Voluntary Cancellation
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product (s) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit a completed Data Call-in Response Form,
indicating your election of this option. Voluntary cancellation is item number b on both the
Generic and Product Specific Data Call-in Response Forms. If you choose this
option, you must complete both Data Call-in response forms. These are the only forms that
you are required to complete.
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If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
b. Satisfying the Product Specific Data Requirements of this Notice.
There are various options available to satisfy the product specific data requirements of
this Notice. These options are discussed in Section III-C.2. of this Notice and comprise
options 1 through 6 of item 9 in the instructions for the product specific Requirements Status
and Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product
specific data requirements for an MUP or EUP as applicable) on the product specific Data
Call-in Response Form. Note that the options available for addressing product specific data
requirements differ slightly from those options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements. It is important to ensure that you are using the correct
forms and instructions when completing your response to the Reregistration Eligibility
Decision document.
c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section III-D.2. of this Notice and
are covered by option 7 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose this option, you must submit the Data Call-in
Response Form and the Requirements Status and Registrant's Response Form as well as any
other information/data pertaining to the option chosen to address the data requirement. Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1. Generic Data
If you acknowledge on the Generic Data Call-In Response Form that you agree to
satisfy the generic data requirements (i.e. you select item number 6b), then you must select
one of the six options on the Generic Requirements Status and Registrant's Response Form
related to data production for each data requirement. Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production are
the first six options discussed under item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide you to additional instructions
provided in this Section. The options are:
(1) I will generate and submit data within the specified timeframe (Developing
Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
I have made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an
Existing Study)
Option 1. Developing Data
If you choose to develop the required data it must be in conformance with Agency
deadlines and with other Agency requirements as referenced herein and in the attachments. All
data generated and submitted must comply with the Good Laboratory Practice (GLP) rule (40
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CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and be
in conformance with the requirements of PR Notice 86-5. In addition, certain studies require
Agency approval of test protocols in advance of study initiation. Those studies for which a
protocol must be submitted have been identified in the Requirements Status and Registrant's
Response Form and/or footnotes to the form. If you wish to use a protocol which differs from
the options discussed in Section II-C of this Notice, you must submit a detailed description of
the proposed protocol and your reason for wishing to use it. The Agency may choose to reject
a protocol not specified in Section II-C. If the Agency rejects your protocol you will be
notified in writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from the date you
are required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost share or agreeing to share in the cost of
developing that study. This 90-day progress report must include the date the study was or will
be initiated and, for studies to be started within 12 months of commitment, the name and
address of the laboratory(ies) or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year,
interim reports must be submitted at 12 month intervals from the date you are required to
commit to generate or otherwise address the requirement for the study. In addition to the other
information specified in the preceding paragraph, at a minimum, a brief description of current
activity on and the status of the study must be included as well as a full
description of any problems encountered since the last progress report.
The time frames in the Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing for the submission of completed study reports or
protocols. The noted deadlines run from the date of the receipt of this Notice by the registrant.
If the data are not submitted by the deadline, each registrant is subject to receipt of a Notice of
Intent to Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to
the Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your request, the
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the cost of producing the required
data but will not be submitting the data yourself, you must provide the name of the registrant
who will be submitting the data. You must also provide EPA with documentary evidence that
an agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
may resolve their differences through binding arbitration.
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Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful, you
may request EPA (by selecting this option) to exercise its discretion not to suspend your
registration (s), although you do not comply with the data submission requirements of this
Notice. EPA has determined that as a general policy, absent other relevant considerations, it
will not suspend the registration of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but the other
registrant^) developing the data has refused to accept the offer. To qualify for this option, you
must submit documentation to the Agency proving that you have made an offer to another
registrant (who has an obligation to submit data) to share in the burden of developing that
data. You must also submit to the Agency a completed EPA Form 8570-32, Certification of
Offer to Cost Share in the Development of Data, Attachment 7. In addition, you must
demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost-sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition
to anything else, offer to share in the burden of producing the data upon terms to be agreed to
or, failing agreement, to be bound by binding arbitration as provided by FIFRA section
3(c)(2)(Bj(iii) and must not qualify this offer. The other registrant must also inform EPA of its
election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this N otice.
In order for you to avoid suspension under this option, you may not withdraw 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. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well as that of the other registrant normally will be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit, the required data in the
specified time frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.
Option 4. Submitting an Existing Study
If you choose to submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this Notice. You may only
submit a study that has not been previously submitted to the Agency or previously cited by
anyone. Existing studies are studies which predate issuance of this Notice. Do not use this
option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly Met:
a. You must certify at the time that the existing study is submitted that the raw
data and specimens from the study are available for audit and review and you
must identify where they are available. This must be done in accordance with
the requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR
Part 160. As stated in 40 CFR 160.3 'Raw data' means any laboratory
worksheets, records, memoranda, notes, or exact copies thereof, that are the
result of original observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
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transcribed verbatim, dated, and verified accurate by signature), the exact copy
or exact transcript may be substituted for the original source as raw data. 'Raw
data' may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded data
from automated instruments." The term "specimens", according to 40 CFR
160.3, means "any material derived from a test system for examination or
analysis."
b. Health and safety studies completed after May 1984 also must also contain all
GLP-required quality assurance and quality control information, pursuant to the
requirements or 40 CFR Part 160. Registrants also must certify at the time of
submitting the existing study that such GLP information is available for post
May 1984 studies by including an appropriate statement on or attached to the
study signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the
study clearly meets the purpose of the PAG. The registrant is referred to 40
CFR 158.70 which states the Agency's policy regarding acceptable protocols. If
you wish to submit the study, you must, in addition to certifying that the
purposes of the PAG are met by the study, clearly articulate the rationale why
you believe the study meets the purpose of the PAG, including copies of any
supporting information or data. It has been the Agency's experience that studies
completed prior to January 1970 rarely satisfied the purpose of the PAG and
that necessary raw data usually are not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements
of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed
in the final protocol and study.
If you know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
files, you need only cite it along with the notification. If not in the Agency's files, you must
submit a summary and copies as required by PR Notice 86-5.
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Option 5. Upgrading a Study
If a study has been classified as partially acceptable and upgradeable, you may submit
data to upgrade that study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
be required to submit new data normally without any time extension. Deficient, but
upgradeable studies will normally be classified as supplemental. However, it is important to
note that not all studies classified! as supplemental are upgradeable. If you have questions
regarding the classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale" of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number (s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option also should be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID nurriber of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally, your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with each
of those criteria, as well as a certification regarding protocol compliance with Agency
requirements.
Option 6. Citing Existing Studies
If you choose to cite a study that has been previously submitted to EPA, that study
must have been previously classified by EPA as acceptable, or it must be a study which has
not yet been reviewed by the Agency. Acceptable toxicology studies generally will have been
classified as "core-guideline" or "core-minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all other disciplines the classification
would be "acceptable." With respect to any studies for which you wish to select this option,
you must provide the MRID number of the study you are citing and, if the study has been
reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements.
2. Product Specific Data
If you acknowledge on the product specific Data Call-in Response Form that you agree
to satisfy the product specific data requirements (i.e. you select option (a or Yb), then you
must select one of the six options on the Requirements Status and Registrant's Response Form
related to data production for each data requirement. Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production are
the first six options discussed under item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form. These six options are listed immediately below with
information in parentheses to guide registrants to additional instructions provided in this
Section. The options are:
(1) I will generate and submit data within the specified time-frame (Developing
Data)
(2) I have entered into an agreement with one or more registrants to develop data
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(Cost Sharing)
1 have made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been
submitted but not reviewed by the Agency (Citing an Existing Study)
Option 1. Developing Data — The requirements for developing product specific data are the
same as those described for generic data (see Section III.C.I, Option 1) except that normally
no protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data — If you enter into an agreement to cost
share, the same requirements apply to product specific data as to generic data (see Section
III.C.I, Option 2). However, registrants may only choose this option for acute toxicity data
and certain efficacy data and only if EPA has indicated in the attached data tables that your
product and at least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which data will be submitted must be noted
in the agreement to cost share by the registrant selecting this option.
Option 3. Offer to Share in the Cost of Data Development —The same requirements for
generic data (Section lll.C.l., Option 3) apply to this option. This option only applies to acute
toxicity and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study — The same requirements described for generic data
(see Section lll.C.l" Option 4) apply to this option for product specific data.
Option 5 .Upgrading a Study — The same requirements described for generic data (see Section
lll.C.l., Option b) apply to this option for product specific data.
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section lll.C.l" Option 6) apply to this option for product specific data.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (lll.C.l.), as appropriate.
III-D REQUESTS FOR DATA WAIVERS
1. Generic Data
There are two types of data waiver responses to this Notice. The first is a request for a
low volume/minor use waiver and the second is a waiver request based on your belief that the
data requirement(s) are not appropriate for your product.
a. Low Volume/Minor Use Waiver
Option 8 under item 9 on the Requirements Status and Registrant's Response
Form. Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of
requiring data for low volume, minor use pesticides. In implementing this provision,
EPA considers low volume pesticides to be only those active ingredients whose total
production volume for all pesticide registrants is small. In determining whether to grant
a low volume, minor use waiver, the Agency will consider the extent, pattern and
volume of use, the economic incentive to conduct the testing, the importance of the
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pesticide, and the exposure and risk from use of the pesticide. If an active ingredient is
used for both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient are low volume and the combined volumes
for all uses are also low, then an exemption may be granted, depending on review of
other information outlined below. An exemption will not be granted if any registrant of
the active ingredient elects to conduct the testing. Any registrant receiving a low
volume minor use waiver must remain within the sales figures in their forecast
supporting the waiver request in order to remain qualified for such waiver. If granted a
waiver, a registrant will be required, as a condition of the waiver, to submit annual
sales reports. The Agency will respond to requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the following
information, as applicable to your product(s), as part of your 90-day response to this
Notice:
(i). Total company sales (pounds and dollars) of all registered product(s)
containing the active ingredient. If applicable to the active ingredient, include foreign
sales for those products that are not registered in this country but are applied to sugar
(cane or beet), coffee, bananas, cocoa, and other such crops. Present the above
information by year for each of the past five years.
(ii) Provide an estimate of the sales (pounds and dollars) of the active
ingredient for each major use site. Present the above information by year for each of
the past five years.
(iii) Total direct production cost of product(s) containing the active ingredient
by year for the past five years. Include information on raw material cost, direct labor
cost, advertising, sales and marketing, and any other significant costs listed separately.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product (s) containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were directly related to the active
ingredient, such as costs of initial registration and any data development.
(v) A list of each data requirement for which you seek a waiver. Indicate the
type of waiver sought and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill each of these
data requirements.
(vi) A list of each data requirement for which you are not seeking any waiver
and the estimated cost to you (listed separately for each data requirement and associated
test) of conducting the testing needed to fulfill each of these data requirements.
(vii) For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient, direct production costs of product(s)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of product (s) containing the active ingredient (following the
parameters in item 3 above), and costs of data development pertaining to the active
ingredient.
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(viii) A description of the importance and unique benefits of the active
ingredient to users. Discuss the use patterns and the effectiveness of the active
ingredient relative to registered alternative chemicals and non-chemical control
strategies. Focus on benefits unique to the active ingredient, providing information that
is as quantitative as possible. If you do not have quantitative data upon which to base
your estimates, then present the reasoning used to derive your estimates. To assist the
Agency in determining the degree of importance of the active ingredient in terms of its
benefits, you should provide information on any of the following factors, as applicable
to your product(s): (a) documentation of the usefulness of the active ingredient in
Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient, as opposed to its registered alternatives,
(c) information on the breakdown of the active ingredient after use and on its
persistence in the environment, and (d) description of its usefulness against a pest(s) of
public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the
request for a waiver.
b. Request for Waiver of Data
Option 9, under Item 9, on the Requirements Status and Registrant's Response
Form. This option may be used if you believe that a particular data requirement should
not apply because the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You also must
submit the current label(s) of your product(s) and, if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice are not appropriate to your
product(s), you will not be required to supply the data pursuant to section 3(c)(2)(B). If
EPA determines that the data are required for your product(s) you must choose a ~~
method of meeting the requirements of this Notice within the time frame provided by
this Notice. Within 30 days of your receipt of the Agency's written decision, you must
submit a revised Requirements Status and Registrant s Response Form indicating the
option chosen.
2. Product Specific Data
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. (Note: any supplemental data must be submitted in the format required by PR
Notice 86-5). This will be the only opportunity to state the reasons or provide
information in support of your request. If the Agency approves your waiver request,
you will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA. If
the Agency denies your waiver request, you must choose an option for meeting the data
requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the product specific Requirements
Status and Registrant's Response Form. Product specific data requirements tor product
chemistry, acute toxicity and efficacy (where appropriate) are required for all products
and the Agency would grant a waiver only under extraordinary circumstances. You
should also be aware that submitting a waiver request will not automatically extend the
due date for the study in question. Waiver requests submitted~without adequate
supporting rationale will be denied and the original due date will remain in force.
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SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
JNUTHJK
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant
to FIFRA section 3 (c) (2) (B). Events which may be the basis for issuance of a Notice of Intent
to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a
study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to
any option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration
concerning joint data development or failure to comply with any terms of a data
waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer
or failure of a registrant on whom you rely for a generic data exemption either
to:
i. Inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-In Response Form and a Requirements Status and Registrant's
Response Form.
ii. Fulfill the commitment to develop and submit the data as required by this
Notice; or
iii. Otherwise take appropriate steps to meet the requirements stated in this
Notice,
unless you commit to submit and do submit the required data in the specified
time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any
time following the issuance of this Notice.
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IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1) EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection
of species, number of animals, sex and distribution of animals, dose and effect levels to
be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2) EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3) EPA requirements regarding the reporting of data, including the manner of
reporting, the completeness of results, and the adequacy of any required supporting (or
raw) data, including, but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted in the form of a final
report; a preliminary report will not be considered to fulfill the submission
requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3 (c) (2) (B) data request is outstanding generally would
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances. If you believe such disposition of existing stocks of your product (s)
which may be suspended for failure to comply with this Notice should be permitted, you have
the burden of clearly demonstrating to EPA that granting such permission would be consistent
with the Act. You also must explain why an "existing stocks" provision is necessary, including
a statement of the quantity of existing stocks and your estimate of the time required for their
sale, distribution, and use. Unless you meet this burden, the Agency will not consider any
request pertaining to the continued sale, distribution, or use of your existing stocks after
suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required
by this Notice will not result in the agency granting any additional time to sell, distribute, or
use existing stocks beyond a year from the date the 90 day response was due, unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3-year study is scheduled to be submitted, all progress
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reports and other information necessary to establish that you have been conducting the study in
an acceptable and good faith manner must have been submitted to the Agency, before EPA
will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
LJJMREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6 (a) (2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies,
regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person(sj listed in Attachment 1, the Data Call-in Chemical Status
Sheet.
All responses to this Notice must include completed Data Call-in Response Forms
(Attachment 2|and completed Requirements Status and Registrant's Response Forms
(Attachment 3), for both (generic and product specific data) and any other documents required
by this Notice, and should be submitted to the contact person(s) identified in Attachment 1. If
the voluntary cancellation or generic data exemption option is chosen, only the Generic and
Product Specific Data Call-in Response Forms need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance
Assurance (OECA), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Louis P. True, Jr., Acting Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Caii-ln and Product Specific Data Call-In Response Forms with
Instructions
3 - Generic Data Call-in and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Confidential Statement of Formula, Cost Share and Data Compensation Forms
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Attachment 1. Chemical Status Sheets
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Hexazinone DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing Hexazinone.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point or contact tor inquiries pertaining to the reregistration of
Hexazinone. This attachment is to be used in conjunction with (1) the Generic Data Call-In
Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the Requirements
Status and Registrant's Form (Attachment 2), (4) a list of registrants receiving this DCI
(Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and
Data Compensation Forms in replying to this Hexazinone Generic Data Call-In (Attachment
F). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for
Hexazinone are contained in the Requirements Status and Registrant's Response Attachment
C. The Agency has concluded that additional product chemistry data on Hexazinone are
needed. These data are needed to fully complete the reregistration of all eligible Hexazinone
products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Andrew Ertman at (703) 308-8063.
All responses to this Notice for the generic data requirements should be submitted to:
Andrew Ertman, Chemical Review Manager
Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Hexazinone
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HEXAZINONE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product (s) containing Hexazinone.
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact tor inquiries pertaining to the reregistration of
Hexazinone. This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Hexazinone Product
Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Hexazinone are
contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency
has concluded that additional data on Hexazinone are needed tor specific products. These data
are required to be submitted to the Agency within the time frame listed. These data are
needed to fully complete the reregistration of all eligible Hexazinone products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Hexazinone, please contact
Andrew Ertman at (703) 308-8063.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Franklin Gee at (703) 308-8008.
(703) 305-8590.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
C.P. Moran
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Hexazinone
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Attachment 2. Combined Generic and Product Specific
Data Call-In Response Forms (Form A inserts) Plus
Instructions
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Instructions For Completing The "Data Call-in Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-In Response Forms"
and are to be used By registrants to respond to generic and product specific Data Call-Ins as
part of EPA's Reregistration Program under the Federal Insecticide, Fungicide, and
Rodenticide Act. The type of data call-in (generic or product specific) is indicated in item
number 3 ("Date and Type of DCI") on each form. BOTH "Data Call-In Response" forms
must be completed.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling out
the forms.
EPA has developed these forms individually for each registrant, and has pre-printed these
forms with a number of items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 have been pre-printed on the form. Items 5 through 7 must be completed
by the registrant as appropriate. Items 8 through 11 must be completed by the registrant
oefore submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this burden, to Chief,
Information Policy Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M
St., S.W., Washington, D.C. 20460; and to the Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Item l.ON BOTH FORMS: This item identifies your company name, number and address.
Item 2.ON BOTH FORMS: This item identifies the case number, case name, EPA chemical
number and chemical name.
Item 3.ON BOTH FORMS: This item identifies the type of Data Call-in. The date of
issuance is date stamped.
Item 4.ON BOTH FORMS: This item identifies the EPA product registrations relevant to
the data call-in. Please note that you are also responsible for informing the Agency of your
response regarding any product that you believe may be covered by this Data Call-in but that
is not listed by the Agency in Item 4. You must bring any such apparent omission to the
Agency's attention within the period required for submission of this response form.
Item 5.ON BOTH FORMS: Check this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of that request. Since this Data Call-in
requires both generic and product specific data, you must complete item 5 on both Data Call-
in response forms. You do not need to complete any item on the Requirements Status and
Registrant's Response Forms.
Item 6a.ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
generic data as indicated in Item 3 and you are eligible for a Generic Data Exemption for the
chemical listed in Item 2 and used in the subject product. By electing this exemption, you
agree to the terms and conditions of a Generic Data Exemption as explained in the Data
Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA registration Number
of each registered source of that active ingredient that you use in your product.
Typically, if you purchase an EPA-registered product from one or more other producers
(who, with respect to the incorporated product, are in compliance with this and any other
outstanding Data Call-In Notice), and
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Caii-in
incorporate that product into all your products, you may complete this item for all products
listed on this form. If, however, you produce the active ingredient yourself, or use any
unregistered product (regardless of the fact that some of your sources are registered), you
may not claim a Generic Data Exemption and you may not select this item.
Item 6b.ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is for
generic data as indicated in Item 3 and if you are agreeing to satisfy the generic data
requirements of this Data Call-In. Attach the Requirements Status and Registrant's Response
Form that indicates how you will satisfy those requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
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Item 7a.ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing use
product (MUP) for which you wish to maintain registration, you must agree to satisfy the data
requirements by responding "yes."
Item Tb.For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes.
FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if your product
is identical to another product and you qualify for a data exemption. You must provide the
EPA registration numbers of your source (s); do not complete the Requirements Status and
Registrant's Response form. Examples of such products include repackaged products and
Special Local Needs (Section 24c) products which are identical to federally registered
products.
If you are requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with option 7 (Waiver
Request) for each study for which you are requesting a waiver.
NOTE: Item 7 a and 7b are not applicable for Generic Data.
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Caii-ln
Item 8.ON BOTH FORMS: This certification statement must be signed by an authorized
representative of your company and the person signing must include his/her title. Additional
pages used in your response must be initialled and dated in the space provided for the
certification.
Item 9.ON BOTH FORMS: Enter the date of signature.
Item 10.ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11.ON BOTH FORMS: Enter the phone number of your company contact.
Note: You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you may wish to
report that your product has already been transferred to another company or that you have already voluntarily cancelled this product. For these cases,
please supply all relevant details so that EPA can ensure that its records are correct.
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Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms (Form B inserts)
and Instructions
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Instructions For Completing
The
"Requirements Status and Registrant's Response Forms"
For The Generic and Product Specific Data Call-in
INTRODUCTION
These instructions apply to the Generic and Product Specific "Requirements Status and
Registrant's Response Forms" and are to be used by registrants to respond to generic and
product specific Data Call-in's as part of EPA's reregistration program under the Federal
Insecticide, Fungicide, and Rodenticide Act. The type of Data Call-In (generic or product
specific) is indicated in item number 3 ("Date and Type of DCI") on each form. Both
"Requirements Status and Registrant's Response" forms must be completed.
Although the form is the same for both product specific and generic data, instructions
for completing the forms differ slightly. Specifically, options for satisfying product specific
data requirements do not include (1) deletion of uses or (2) request for a low volume/minor
use waiver. Please read these instructions carefully before filling out the forms.
EPA has developed these forms individually for each registrant, and has pre-printed
these forms to include certain information unique to this chemical. DO NOT use these forms
for any other active ingredient.
Items 1 through 8 have been pre-printed on the form. Item 9 must be completed by the
registrant as appropriate. Items 10 through 13 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average
30 minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this burden, to Chief,
Information Policy Branch, Mail Code 213o, U.S. Environmental Protection Agency, 401 M
St., S.W., Washington, D.C. 20460; and to the Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
Item 1. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2. ON THE GENERIC DATA FORM: This item identifies the case number,
case name, EPA chemical number and chemical name.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
case number, case name, and the EPA Registration Number of the product for
which the Agency is requesting product specific data.
Item 3. ON THE GENERIC DATA FORM: This item identifies the type of Data
Call-In. The date of issuance is date stamped.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the type
of Data Call-In. The date of issuance is also date stamped. Note the unique
identifier number (ID#) assigned by the Agency. This ID number must be used
in the transmittal document for any data submissions in response to this Data
Call-In Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline reference number of
studies required. These guidelines, in addition to the requirements specified in
the Data Call-in Notice, govern the conduct of the required studies. Note that
series 61 and 62 in product chemistry are now listed under 40 CFR 158.155
through 158.180, Subpart c.
Item 5. ON BOTH FORMS: This item identifies the study title associated with the
guideline reference number and whether protocols and 1, 2, or 3-year progress
reports are required to be submitted in connection with the study. As noted in
Section III of the Data Call-In Notice, 90-day progress reports are required for
all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's
Response Form.
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE HJRMS"
Generic and Product Specific Data Caii-ln
Item 6. ON BOTH FORMS: This item identifies the code associated with the use
pattern of the pesticide. In the case of efficacy data (product specific
requirement), the required study only pertains to products which have the use
sites and/or pests indicated. A brief description of each code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
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Item 7.
Item 8.
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
0 Indoor residential
ON BOTH FORMS: This item identifies the code assigned to the substance
that must be used for testing. A brief description of each code follows:
EUP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TEP/MET
TEP/PAI/M
TGAI
TGAI/PAI
TGAI/PAIRA
TGAI/TEP
MET
IMP
DEGR
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade Active
Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Ingredient or Pure Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active Ingredient and
Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient or Typical End-Use
Product
Metabolites
Impurities
Degradates
See: guideline comment
This item completed by the Agency identifies the time frame allowed for
submission of the study or protocol identified in item 5.
ON THE GENERIC DATA FORM: The time frame runs from the date of
your receipt of the Data Call-In notice.
ON THE PRODUCT SPECIFIC DATA FORM: The due date for
submission of product specific studies begins from the date stamped on the letter
transmitting the Reregistration Eligibility Decision document, and not from the
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date of receipt. However, your response to the Data Call-in itself is due 90
days from the date of receipt.
Item 9. ON BOTH FORMS: Enter the appropriate Response Code or Codes to show
how you intend to comply with each data requirement. Brief descriptions of
each code follow. The Data Call-In Notice contains a fuller description of each
of these options.
Option 1. ON BOTH FORMS: (Developing Data) I will conduct a new study and
submit it within the time frames specified in item 8 above. By indicating
that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as
outlined in the Data Call-In Notice and that I will provide the protocols
and progress reports required in item 5 above.
Option 2. ON BOTH FORMS: (Agreement to Cost Share) I have entered into an
agreement with one or more registrants to develop data jointly. By
indicating that I have chosen this option, I certify that I will comply with
all the requirements pertaining to sharing in the cost of developing data
as outlined in the Data Call-In Notice.
However, for Product Specific Data, I understand that this
option is available for acute toxicity or certain efficacy data ONLY if
the Agency indicates in an attachment to this notice that my product is
similar enough to another product to qualify for this option. I certify that
another party in the agreement is committing to submit or provide the
required data; if the required study is not submitted on time, my product
may be subject to suspension.
Option 3. ON BOTH FORMS: (Offer to Cost Share) I have made an offer to
enter into an agreement with one or more registrants to develop data
jointly. I am also submitting a completed "Certification of offer to Cost
Share in the Development of Data" form. I am submitting evidence that
I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am including a copy of
my offer and proof of the other registrant's receipt of that offer. I am
identifying the party which is committing to submit or provide the
required data; if the required study is not submitted on time, my product
may be subject to suspension. I understand that other terms under Option
3 in the Data Call-In Notice apply as well.
However, for Product Specific Data, I understand that this
option is available only for acute toxicity or certain efficacy data and
only if the Agency indicates in an attachment to this Data Call-in Notice
that my product is similar enough to another product to qualify for this
option.
Option 4. ON BOTH FORMS: (Submitting Existing Data) I will submit an
existing study by the specified due date that has never before been
submitted to EPA. By indicating that I have chosen this option, I certify
that this study meets all the requirements pertaining to the conditions for
submittal of existing data outlined in the Data CalHn Notice and I have
attached the needea supporting information along with this response.
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Options. ON BOTH FORMS: (Upgrading a Study) I will submit by the
specified due date, or will cite data to upgrade a study that EPA has
classified as partially acceptable and potentially upgradeable. By
indicating that I have chosen this option, I certify that I have met all the
requirements pertaining to the conditions for submitting or citing
existing data to upgrade a study described in the Data Call-in Notice. I
am indicating on attached correspondence the Master Record
Identification Number (MRID) that EPA has assigned to the data that I
am citing as well as the MRID of the study I am attempting to upgrade.
Option 6. ON BOTH FORMS: (Citing a Study) I am citing an existing study
that has been previously classified by EPA as acceptable, core, core
minimum, or a study that has not yet been reviewed by the Agency. If
reviewed, I am providing the Agency's classification of the study.
However, for Product Specific Data, I am citing another
registrant's study. I understand that this option is available ONLY for
acute toxicity or certain efficacy data and ONLY if the cited study was
conducted on my product, an identical product or a product which the
Agency has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing
my own data. In either case, I will provide the MRID or Accession
number (s). If I cite another registrant's data, I will submit a completed
"Certification With Respect To Data Compensation Requirements"
form.
FOR THE GENERIC DATA FORM ONLY: The following three options
(Numbers 7,8, and U) are responses that apply only to the 'Requirements Status
and Registrant's Response Form" for generic data.
Option 7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
Option 8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In
Notice and I request a low-volume minor use waiver of the data
requirement. I am attaching a detailed justification to support this waiver
request including, among other things, all information required to
support the request. I understand that, unless modified by the Agency in
writing, the data requirement as stated in the Notice governs.
Option 9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than low-volume minor-use data waivers in the Data
Call-In Notice and I request a waiver of the data requirement. I am
attaching a rationale explaining why I believe the data requirements do
not apply. I am also submitting a copy of my current labels. (You must
also submit a copy of your Confidential Statement of Formula if not
already on file with EPA). I understand that, unless modified by the
Agency in writing, the data requirement as stated in the Notice governs.
FOR PRODUCT SPECIFIC DATA: The following option (number 7) is a
response that applies to the "Requirements Status and Registrant's Response
Form" for product specific data.
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Option 7. (Waiver Request) I request a waiver for this study because it is
inappropriate tor my product. I am attaching a complete justification for
this request, including technical reasons, data and references to relevant
EPA regulations, guidelines or policies. [Note: any supplemental data
must be submitted in the format required by P.R. Notice 86-5]. I
understand that this is my only opportunity to state the reasons or
provide information in support of my request. If the Agency approves
my waiver request, I will not be required to supply the data pursuant to
Section 3(c) (2) (B) of FIFRA. If the Agency denies my waiver request,
I must choose a method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I must, within 30
days-of my receipt of the Agency's written decision, submit a revised
"Requirements Status" form specifying the option chosen. I also
understand that the deadline for submission of data as specified by the
original Data Call-In notice will not change.
Item 10. ON BOTH FORMS: This item must be signed by an authorized representative
of your company. The person signing must include his/her title, and must initial
and date all other pages of this form.
Item 11. ON BOTH FORMS: Enter the date of signature.
Item 12. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 13. ON BOTH FORMS: Enter the phone number of your company contact.
NOTE: You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example, you may
wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this product. For these
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
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EPA'S DECISION ON BATCHING PRODUCTS CONTAINING HEXAZINONE FOR PURPOSES OF MEETING ACUTE TOXICITY DATA
REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data requirements for reregistration of
products containing the active ingredient hexazinone, the Agency considered batching products. This process involves grouping similar products for
purposes of acute toxicity. Factors considered in the sorting process include each product's active and inert ingredients (identity, percent composition
ana biological activity), type of formulation (e.g., emulsifiabre concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word,
use classification, precautionary labeling, etc.). TNTote that the Agency is not describing batched products as "substantially similar" since some products
within a batch may not be consideredchemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the preceding paragraph. Acute toxicity data on
individual products has frequently been found to be incomplete. Notwithstanding the batching process, the Agency reserves the right to require, at any
time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a single battery of six acute toxicological studies
to represent all the products within that batch. It is me registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute toxicological studies for each of their own products. If a
registrant chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the data base is complete and valid by today's
standards (see acceptance criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute toxicity data. Regardless of whether new data is generated or existing data is
cited, the registrant must clearly identify the material tested by its EPA registration number. If more than one Confidential Statement of Formula (CSF)
exists for a product, the registrant must indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the directions given in the Data Call-in Notice and
its attachments appended to the RED. The DCI Notice contains two response forms which are to be completed and submitted to the Agency within 90
days of receipt. The first form, "Data Call-in Response", asks whether the registrant will meet the data requirements for each product. The second
form, "Requirements Status and Registrant's Response", lists the product specific data required for each product, including the standard six acute toxicity
tests. A registrant who wishes to participate in a batch must decide whether he/she will provide the data or depend on someone else to do so. If a
registrant supplies the data to support a batch of products, he/she must select one of the following options: Developing Data (Option 1), Submitting
an Existing Study (Option 4), Upgrading an Existing Study (Option 5), or Citing an Existing Study (Option 6). If a registrant depends on another's
data, he/she must choose among: Uost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does
not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to participate in a batch
does not preclude other registrants in the batch from citing his/her studies and offering to cost share (Option 3) those studies.
Table I lists the registered products, their active ingredient(s) and formulation type included in the batches identified for hexazinone.
Table 1 : Hexazinone Batching
Batch No.
1
2
3
EPA Reg. No.
352-421
352-422
352-392
FL86000900
MT82001200
NC83001200
NM82002300
TX83000200
WY92000100
352-378
62802-1
FL80001800
TX80002000
% of Hexazinone
1.0
1.25
25.0
25.0
25.0
25.0
25.0
25.0
25.0
90.0
90.0
90.0
90.0
Formulation Type
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
wettable powder
wettable powder in plugs
wettable powder
wettable powder
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Table II lists the registered products which could not be batched. For the purposes of acute toxicity batching, these products were not
considered similar, or their similarity could not be determined with the information available. The registrants of these products are responsible for
meeting the acute toxicity data requirements specified in the data matrix for end-use products.
Table II: Non-Batched Hexazinone Registrations
EPA Reg. No.
228-220
352-450
352-399
7234-76
33560-21
33560-41
33560-45
62802-2
% of Hexazinone
& other Active Ingredients
1.25
75.0
98.7
10.0
10.0
75.0
25.0
72.0
Formulation Type
liquid
granular
technical
pellet
granular
pellet
granular
tablet
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Attachment 1. EPA Acceptance Criteria
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at _>_ 0.1% by weight and for certain lexicologically
significant impurities (e.g., dioxins, nitrosamines) present at < 0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS) Registry Number for each active
ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned experimental or internal code
numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition, properties or toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and the parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity which may be present at _>_ 0.1%
or was found at _>_ 0.1% by product analyses and (2) certain lexicologically significant impurities (see #3).
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present the information in items 6, 7, and
8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and all impurities present at _>_
2. Degree of accountability or closure _>_ ca 98%.
3. Analyses conducted for certain trace" toxic impurities at lower than 0.1% (examples, nitrosamines in the case of products containing
dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites; polyhalogenated dibenzodioxins and dibenzofurans).
[Note that in the case of nitrosamines both fresh and stored samples must be analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with explanation of how the limits
were determined.
8. Upper certified limit proposed for each impurity present at _>_ 0.1% and for certain lexicologically significant impurities at < 0.1% along
with explanation of now limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt from requirement of
tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy.
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic compounds"
Observed at room temperature
63-5 MeltingPoint
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
Reported in °C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with reference to water at 20° C.
[Note: Bulk density of registered products may be reported ifTlbs/ft3 or Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in formulations and analytical methods
for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if pressure too low to measure at 25°
VvJ
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25°C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3.^ Dosing, single oral may be administered over 24 hrs.
4.*! Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.^ Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.^ Vehicle control, only if toxicity of vehicle is unknown.
7.1 Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours oefore dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplementaLand may not be required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or contains particles of inhalable
size for man (aerodynamic diameter 15 pm or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (+_2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of respirable substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
216
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24nours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.^ Individual daily observations.
Criteria marked with an * are supplementa^and may not be required for every study.
Lj i I
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of <7. or > 11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8. Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days (whichever is shorter).
11.^ Individual daily observations.
Criteria marked with an * are supplementaLand may not be required for every study.
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof <2of >11.5.
3. une oflhe following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.^ Reference for test.
6C Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplementaLand may not be required for every study.
Lj i \J
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220
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Attachment 2. List of All Registrants Sent This Data Call-In (insert) Notice
221
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222
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Attachment 3. Cost Share Data Compensation Forms, Confidential Statement of Formula
Form and Instructions
223
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224
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226
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are
required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party must be provided.
d. All applicable information which is on the product specific data submission must also be reported on the
CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet
for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered source products
must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for
the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported under column 10
and must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will
volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158.175
instructions. An explanation must be provided if the proposed limits are different than standard certified
limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs become obsolete for that
specific formulation.
227
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228
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill In blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FiFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Ofler
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
229
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230
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SEPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
OMt N*. 2070-0107
2070-0037
Approval Expire* 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, includina
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspectI of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch. PM-223. U.S. Environmental Protection Agency. 401 M St., S.W.. Washington. DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington. DC 20503.
Please fill In blanks below.
Company Numb«r
EFA t+g. No.
I Certify that:
1.
For each study cited in support of registration or ^registration under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
That for each study cited in support of registration or ^registration under FIFRA that is NOT an exclusive use
study, I am the original data submitter, or I have obtained the written permission of the original data submitter or I
have notified in writing the company(ies) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(C)(1)(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due. if any. The companies I have notified are: (check one)
I ] The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form.'
3. That I have previously complied with section 3(0(1 )(D) of FIFRA for the studies I have cited in support of
registration or reregistratten under FIFRA.
Signature
Nam* mid Till* (Pica** Typ* or Print)
Date
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to me
registration or reregistration of my products, to the extent required by FIFRA sections 3(O(1)(D) and 3(c)(2)(D).
Signature
Nam* and Tltl* (Pl*aa* Typ* or Print)
EPA Form M70.J1 (4-90)
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232
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APPENDIX G. FACT SHEET
233
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234
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United States
Environmental Protection
Anpnry
Prevention Pesticides
And Toxic Substances
EPA-738-F-94-019
September 1994
&ERA R.E.D. FACTS
Pesticide
Reregistration
Hexazinone
All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered years ago be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency imposes any
regulatory controls that are needed to effectively manage each pesticide's risks.
EPA then reregisters pesticides that can be used without posing unreasonable
risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for reregistration
case 0266, hexazinone.
Use Profile Hexazinone is a herbicide used to control a broad spectrum of weeds
including undesirable woody plants in alfalfa, rangeland and pasture,
woodland, pineapples, sugarcane and blueberries. It is also used on
ornamental plants, forest trees and other non-crop areas. Hexazinone is
registered for pre-emergent, post-emergence, layby, directed spray and basal
soil applications. It is used as a non-selective herbicide in non-cropland areas
and as a selective herbicide in reforestation practices.
Hexazinone products are formulated as granulars, pellets/tablets,
emulsifiable concentrates, ready-to-use liquids, soluble concentrates/solids and
a technical grade active ingredient. Products are applied using aerial or ground
equipment or by hand, or using a hand-held, boom, knapsack or power
sprayer.
Use practice limitations prohibit application of hexazinone through any
type of irrigation system. The pesticide also cannot be applied within 30 to 60
days before grazing, harvest or feeding.
Regulatory Hexazinone is the common name for 3-cyclohexyl-6-(dimethylamino)-l-
HJStorv methyl-1,3,5 triazine-2,4(lH,3H)-dione. Hexazinone was first registered as
a pesticide in the U.S. in 1975 for general weed control in non-cropland areas.
Use in the culture of Christmas and forest trees was added in 1977, and uses
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Human Health
Assessment
on sugarcane and alfalfa were conditionally registered in 1980 and 1981,
respectively.
EPA issued one Registration Standard for hexazinone in February 1982
(NTIS #PB87-110292), and a second in September 1988 (NTIS #PB89-
126080). These documents summarized available data supporting the
registration of hexazinone products, and required additional product chemistry,
residue chemistry, toxicology, ecological effects and environmental fate data.
EPA's Office of Drinking Water issued a drinking water Health Advisory
(HA) for hexazinone in August 1988. A lifetime HA was established at 200
ppb for an adult consuming 2 liters of water per day. For a 10 kg child, a one-
and ten-day HA was determined to be 2 mg/L.
Currently, 20 end-use pesticide products and one technical grade,
manufacturing use product containing hexazinone are registered.
Toxicity
Hexazinone is classified as a Group D carcinogen—a chemical that is not
classifiable as to human carcinogenicity. Animal data presented to EPA is
equivocal—it is not entirely negative, but not convincingly positive. The
Agency has concluded that the evidence cannot be interpreted as showing either
the presence or absence of a carcinogenic effect. Since hexazinone has not
been found to induce cancer, food and feed additive regulations are not
prohibited by the Delaney Clause of the Federal Food, Drug, and Cosmetic
Act (FFDCA). The Reference Dose (RfD) approach was used to assess human
risk from exposure to hexazinone.
In acute toxicity studies using laboratory animals, hexazinone has been
shown to be a severe eye irritant and has been placed in Toxicity Category I
(the highest of four levels) for primary eye irritation. It is slightly toxic
through the acute oral route (Toxicity Category III) and very mildly toxic
through the acute dermal and acute inhalation routes (Toxicity Category IV).
Hexazinone is only mildly toxic for skin irritation potential (Toxicity Category
IV) and is not a skin sensitizer.
Some treatment-related effects were found in developmental toxicity
studies using rats and rabbits, at the high dose levels. Similarly, some effects
were noted in a reproductive toxicity study at the mid- and high dose levels.
Hexazinone was positive in one mutagenicity study but negative in the
remaining studies. There are no other acute or chronic toxicological endpoints
of concern.
Dietary Exposure
People may be exposed to residues of hexazinone through their diet.
EPA reassessed existing tolerances or maximum residue limits (please see 40
CFR 180.396) for blueberries, pineapple and sugarcane at the time of this
RED. Tolerances for meat, meat byproducts and milk cannot be reassessed
until a cattle feeding study is completed. However, sufficient data were
available to conduct a risk assessment, and the Agency believes that the
existing tolerances are protective until data are available for reassessment.
The Reference Dose (RfD) or amount believed not to cause adverse
effects if consumed daily over a 70-year lifetime is 0.05 mg/kg/day based upon
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a No Observable Effect Level (NOEL) of 5 mg/kg/day in a one-year feeding
study in dogs. EPA calculated that the Anticipated Residue Contribution
(ARC) for the overall U.S. population from all hexazinone tolerances equals
7% of the RfD. The ARC for the subgroup most highly exposed, non-nursing
infants age less than 1 year, represents 40% of the RfD, while the ARC for
children age 1 to 6 years is 20% of the RfD. EPA's calculations overestimate
exposure, however, by assuming 100% of crop treated for all commodities.
Actual dietary risk from hexazinone is believed to be minimal. When current
residue chemistry data gaps are filled, however, dietary exposure estimates for
hexazinone could change.
Hexazinone concentrates in certain processed fractions of alfalfa,
pineapple and sugarcane. EPA has determined that establishing food and feed
additive tolerances for these commodities is appropriate and consistent with the
Delaney Clause of the FFDCA, and that such tolerances must be established
for alfalfa meal, pineapple processing residue and sugarcane molasses.
EPA's Office of Water has issued a lifetime Health Advisory (HA) which
sets a maximum level of 0.21 mg/L, or 200 ppb allowable in drinking water.
No international CODEX Maximum Residue Limits are established for
hexazinone so compatibility with U.S. tolerances is not an issue.
Occupational and Residential Exposure
Based on current use patterns, workers may be exposed to hexazinone
during and after applications in agricultural and other settings. In assessing
handler and post-application exposure, Agency concerns are predominantly
related to skin contact. Hexazinone is poorly absorbed through the skin, so
little or no absorption is anticipated. Therefore, no changes in personal
protective equipment (PPE) required by the Worker Protection Standard (WPS)
are being imposed at this time. However, the Restricted Entry Interval (REI)
is being changed from 24 to 48 hours because hexazinone is in Toxicity
Category I for primary eye irritation.
There are no residential uses of hexazinone, so residential exposure is not
expected.
Human Risk Assessment
Hexazinone generally is of relatively low acute toxicity but is a severe
eye irritant (Toxicity Category I). It is not classifiable as to human
carcinogenicity (Group D carcinogen) and does not cause other toxic effects of
concern.
The dietary risk posed by hexazinone is expected to be minimal. Most
tolerances were reassessed and other existing tolerances are considered
protective until confirmatory data are available for reassessment. A lifetime
Health Advisory sets a maximum level of exposure to hexazinone from
drinking water.
Exposure to workers and other applicators generally is not expected to
pose undue risks, due to hexazinone's overall low acute toxicity. However,
based on toxicity concerns regarding primary eye irritation, a 48-hour rather
than a 24-hour REI is required.
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Environmental Environmental Fate
AsSGSSITIGnt Based on laboratory data and confirmed by field and forestry data,
hexazinone appears to be persistent and mobile in soil and aquatic
environments. The degradates of hexazinone also are believed to be persistent
and mobile. Hexazinone was reported in runoff water up to 6 months post-
treatment in a forestry dissipation study. Therefore, field and laboratory data
indicate that hexazinone may be of concern for both groundwater and surface
water contamination.
Hexazinone has been detected in ground water (at levels well below the
Health Advisory) in Hawaii, Florida, Maine and North Carolina. Hexazinone
also can contaminate surface water by spray drift at application, and for several
months post-application via runoff. It is not expected to accumulate in fish but
does accumulate in crops grown on treated soil.
Ecological Effects
Hexazinone is practically non-toxic to birds on an acute oral and subacute
dietary basis. It is practically non-toxic to freshwater fish and freshwater
invertebrates in acute exposures. Hexazinone is practically nontoxic to
mollusks, slightly toxic to crustaceans, and relatively non-toxic to honey bees.
Ecological Effects Risk Assessment
Exposure of non-target organisms to hexazinone can result from direct
application, spray drift from treated areas, and runoff from treated areas. Such
exposure would be chronic as well as acute.
Hexazinone exceeds the levels of concern (LOG) for terrestrial and
aquatic plants, at all application rates, using aerial and ground equipment.
Contamination of aquatic sites adjacent to treated areas could be of great
ecological significance and may be exacerbated by the persistence and mobility
of hexazinone.
Aquatic plants are an important component of the ecosystem. Algae are
the link between solar radiation, aquatic animals and humans, which are
dependent on the oxygen produced by algae during photosynthesis. Algae are
responsible for maintaining the quality of the aquatic habitat for fish, while at
the same time providing food for fish either directly or indirectly. Effects to
aquatic plants expected from the use of hexazinone may alter aquatic
ecosystems, the severity of which is dependent on the frequency of application
and the nature of the receiving body of water.
Hexazinone also exceeds the LOG for small mammals at several of the
higher application rates.
Risk to Endangered Species
Hexazinone exceeds the endangered species LOCs for grass- and insect-
eating mammals at use rates of 3.6 pounds active ingredient per acre (Ib
ai/acre) or greater. It also exceeds the LOCs for both aquatic and terrestrial
plants at all use rates.
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Risk Mitigation Measures
Hexazinone exceeds the levels of concern for both aquatic and terrestrial
plants, and exceeds levels of concern for small mammals at several of the
higher application rates. Hexazinone also is likely to have a significant impact
on ground water quality. In areas where irrigation water is contaminated with
hexazinone or where ground water discharges to surface water, hexazinone
residues in water could pose a threat to plants. Therefore, the following risk
mitigation measures are required:
• All hexazinone product labels must carry a ground water advisory;
• Registrants must report any domestic hexazinone ground water
detections at any levels to EPA;
• The registrant must prepare a report summarizing ongoing research
regarding ground water detections in the State of Maine;
• The registrant also must submit to EPA the educational materials
under development regarding product stewardship and addressing the
potential for ground water contamination from use of hexazinone;
• A prospective ground water monitoring study must be conducted to
determine the potential for hexazinone to leach to ground water;
• To address surface water concerns, precautionary label language will
be required;
• To address the risk to nontarget plants and small mammals, the
maximum application rate must be reduced from 13.5 Ib ai/acre to 8 Ib
ai/acre.
• To inform the user of best management practices to minimize spray
drift, EPA is preparing labeling statements that may be required in the
future for all aerially-applied hexazinone products;
• To address endangered aquatic and terrestrial plant species as well as
endangered small mammal concerns, endangered species precautionary
labeling will be required in the future;
• Hexazinone may be classified as a Restricted Use Pesticide for ground
water concerns once the Agency's Ground Water Restricted Use Rule is
finalized.
Additional Data
Required
The Agency is requiring additional generic data on hexazinone's residue
chemistry, ecological effects and environmental fate. The following
confirmatory generic studies are required: residue analytical methods
(ruminant only), magnitude of the residue on grass hay and alfalfa seed
screenings, magnitude of the residue in meat/milk, storage stability (alfalfa
and Metabolite C for grass), rotational crops (sorghum and leafy vegetable),
seed germination/seedling emergence (cucumber, onion, pea), vegetative vigor
(cucumber), batch equilibrium, aquatic sediment dissipation, spray drift, and
a prospective groundwater monitoring study.
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs) and revised labeling for reregistration.
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Product LabGling All hexazinone end-use products must comply with EPA's current
ChanQGS RGCIUirGd pesticide product labeling requirements, and with the following:
Worker Protection Standard (WPS) - EPA has evaluated the 2 4-hour interim
REI established by the WPS and concluded that it should be changed to 48
hours because hexazinone is in Toxicity Category I for primary eye irritation.
The new 48-hour REI must be inserted into the standardized REI statement
required by PR Notice 93-7.
The PPE for early entry under the 48-hour REI for hexazinone is
coveralls, chemical resistant gloves, shoes plus socks, and protective eyewear.
These PPE must be inserted into the early entry PPE statement required by PR
Notice 93-7.
Ground Water Labeling Advisory - All products must carry the following
advisory:
"This chemical is known to leach through soil into ground water under
certain conditions as a result of agricultural use. Use of this chemical in
areas where soils are permeable, particularly where the water table is
shallow, may result in ground water contamination."
Surface Water Labeling - The technical manufacturer of hexazinone is in the
process of consolidating label language relating to surface and ground water for
all of their hexazinone products. After the Agency has reviewed and approved
these label amendments, all hexazinone labels must carry this labeling.
Other Ground Water Requirements
• Registrants must report any domestic hexazinone ground water
detections at any levels to the Agency.
• The registrant must prepare and submit a report summarizing the
ongoing research in Maine regarding ground water detections in
blueberry use areas. This report must be submitted within one year from
receipt of the RED document. The registrant also must prepare a one
year follow-up to the original report.
• The registrant also must submit an analytical method or immuno assay
for detection of hexazinone in ground water, within one year after receipt
of the RED document.
• The registrant is required to submit educational materials that are
currently being developed to the Agency. These materials should be
in specific regard to product stewardship and should address the
potential for ground water contamination from use of hexazinone.
Risk to Non-Target Plants and Small Mammals - To mitigate the risk to
non-target plants and small mammals, registrants must reduce the maximum
application rate from 13.5 Ib ai/acre to 8 Ib ai/acre.
Spray Drift Label Advisory - The Agency is preparing spray drift labeling
statements to inform users of management practices that would minimize
spray drift from the target site. This future labeling may be required for all
hexazinone products that may be applied aerially to agricultural crops.
Endangered Species Statement - EPA is working with the Fish and
Wildlife Service and other Federal and State agencies to develop a program
to avoid jeopardizing the continued existence of identified species by the use
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Attachment 1. EPA Acceptance Criteria
207
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of pesticides. When this program goes into effect, endangered species
precautionary labeling will be required.
Regulatory
Conclusion
For More
Information
The use of currently registered products containing hexazinone in
accordance with approved labeling will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, all uses of these products are
eligible for reregistration.
Hexazinone products will be reregistered once the required product
specific data, revised Confidential Statements of Formula and revised labeling
are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for hexazinone during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources Branch,
Field Operations Division (7506C), Office of Pesticide Programs (OPP), US
EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded from
the Pesticide Special Review and Reregistration Information System at 703-
308-7224, and also can be reached on the Internet via FEDWORLD.GOVand
EPA's gopher server, EARTH1.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone 513-
489-8190, fax 513-489-8695.
Following the comment period, the hexazinone RED document will be
available from the National Technical Information Service (NTIS), 5285 Port
Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program, the
hexazinone RED, or reregistration of individual products containing
hexazinone, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides Telecommunications Network (NPTN). Call toll-free 1-
800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday through
Friday.
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