United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(75O8W)
EPA 738-R-94-016
September 1994
&EPA
Reregistration
Eligibility Decision (RED)
Oryzalin
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
CERTIFIED MAIL
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
27 JAN 1995
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 oryzalin. 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 date of 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 Judith Coombs at (703) 308-8046,,,,- 7
s' '' /f
•
Sincerely yours,
Enclosures
' Louis P. True, Jr., Acting Director
Special Review and
Reregistration Division
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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 REREGISTRATIQN 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).
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4.
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
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.
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 TJ.S. Mail:
Document Processing Desk (RED-SRRD-0186)
Office of Pesticide Programs (H7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express;
Document Processing Desk (RED-SRRD-0186)
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
ORYZALIN
LIST A
CASE 0186
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
ORYZALIN REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile ....._ .2
C. Data Requirements 6
D. Regulatory History 6
m. SCIENCE ASSESSMENT 7
A. Physical Chemistry Assessment 7
B. Human Health Assessment 7
1. Toxicology 7
a. Acute Toxicity . 8
b. Subchronic Toxicity 9
c. Chronic Toxicity .9
d. Carcinogenicity 10
e. Developmental Toxicity 10
f. Reproduction 11
g. Mutagenicity 11
h. Metabolism 12
i. Dermal Absorption 12
j. Reference Dose (RfD) (for Chronic Oral Exposure) 12
2. Exposure Assessment 13
a. Dietary Exposure 13
b. Occupational and Residential Exposure ............. 15
3. Risk Assessment . 21
C. Environmental Assessment 24
1. Environmental Fate 24
ft. Environmental Chemistry, Fate and Transport 24
b. Environmental Fate Assessment 30
2. Ecological Effects 31
a. Ecological Effects Data 31
(1) Terrestrial Data 31
(2) Aquatic Data 33
(3) Non-Target Insects Data . 34
(4) Non-Target Plants Data 34
3. Ecological Risk Assessment 36
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a. Terrestrial Organisms 36
b. Aquatic Organisms 40
c. Non-Target Plants 43
d. Endangered and Threatened Species 45
IV. RISK MANAGEMENT AND REREGISTRATION DECISION .......... 46
A. Determination of Eligibility 46
1. Eligibility Decision 47
2. Eligible and Ineligible Uses 47
B. Regulatory Position 47
1. Tolerance Reassessment 47
2. Restricted Use Classification 50
3. Reference Dose/Cancer Risk 50
4. Endangered Species Statement 50
5. Worker Protection Requirements 51
(1) Mixer/Loader/Applicator Personal Protective
Equipment (PPE) Requirements for Oryzalin .... 51
(2) Early Entry Personal Protective Equipment (PPE) for
Oryzalin 52
(3) Post-application Entry Restrictions for Oryzalin . . 53
V. ACTIONS REQUIRED BY REGISTRANTS 56
A. Manufacturing-Use Products 56
1. Additional Generic Data Requirements 56
2. Labeling Requirements for Manufacturing-Use Products 57
B. End-Use Products 57
1. Additional Product-Specific Data Requirements 57
2. Labeling Requirements for End-Use Products 57
C. Existing Stocks ; 61
VI. APPENDICES 63
APPENDIX A. Table of Use Patterns Subject to Reregistration 65
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 67
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Oryzalin 79
APPENDIX D. List of Available Related Documents 95
APPENDIXE 99
PR Notice 86-5 101
PR Notice 91-2 119
APPENDIX F. Combined Generic and Product Specific Data Call-in 125
Attachment 1. Chemical Status Sheets 145
Attachment 2. Combined Generic and Product Specific Data Call-in
Response Forms (Form A inserts) Plus Instructions ........ 149
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Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and Instructions
155:
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 163
Attachment 5. EPA Acceptance Criteria 169
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
183
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 185
APPENDIX G. FACT SHEET 195
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ORYZALIN REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Neil Anderson
Gabe Patrick
Ghulam Ali
Environmental Fate and Effects Division
Sharlene Matten
Sara Ager
David Edelstein
Health • Effects • Division
Linda Kutney
Pat McLaughlin
John Bazuin
Paula Deschamp
Jeff Evans
Registration Division
Wesley Allen
Ian Blackwell
Special Review and Reregistration Division
Judith Coombs
Walter Waldrop
Carol Stangel
Office of Compliance Monitoring
Rose Lew
Biological Analysis Branch
LUIS
Economic Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Chemical Coordination Branch
Toxicology Branch II
Science Analysis Branch
Reregistration Support Chemistry Branch
Occupational and Residential Exposure Branch
Fungicide-Herbicide Branch
Reregistration Support Branch
Reregistration Branch
Reregistration Branch
Planning and Reregistration Branch
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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.
HDT Highest Dose Tested
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GLOSSARY OF TERMS AND ABBREVIATIONS
LC
so
LD
'so
LDIO
LEL
LOG
LOEL
MCLG
MP
MPI
MOE
MRID
N/A
NPDES
NOEL
OPP
PADI
PAM
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.
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
Provisional Acceptable Daily Intake
Pesticide Analytical Method
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PPE
ppm
PRN
RED
REI
RfD
RS
TD
TC
TEP
TGAI
TMRC
TLC
WPS
GLOSSARY OF TERMS AND ABBREVIATIONS
Personal Protective Equipment
Parts Per Million
Pesticide Registration Notice
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer
Risk Model
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Registration Standard
Toxic Dose. The dose at which a substance produces a toxic effect.
Toxic Concentration. The concentration at which a substance produces a toxic
effect.
Typical End-Use Product
Technical Grade Active Ingredient
Theoretical Maximum Residue Contribution
Thin Layer Chromatography
Worker Protection Standard
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EXECUTIVE SUMMARY
This Reregistration Eligibility Decision document (RED) addresses the reregistration
eligibility of the pesticide oryzalin, 3,5-dinitro-N4,N4-dipropylsulfanilamide.
Oryzalin is a 2,6-dinitroaniline herbicide produced by DowElanco. It is used to
control annual grasses and broadleaf weeds on berries, vine and orchard crops, Christmas tree
plantations, commercial/industrial and recreation area lawns, golf course turf, residential
lawns and turf, ornamental and/or shade trees, nonagricultural rights-of-way/fencerows,
nonagricultural uncultivated and industrial areas, power stations, paths/patios and paved areas.
Oryzalin is also used to control herbaceous plants, woody shrubs and vines. The end-use
formulations of oryzalin are granular (0.4 to 1% + 1 other active ingredient [a.i.]), wettable
powder (75%), water dispersible granules (60 - 85% + 1 other a.i.), emulsifiable concentrate
(2.84 to 40.4%), flowable concentrate (40.4%), and formulation intermediate/liquid (40.4%).
The registered products are applied by foliar spray, broadcast, band treatment by sprayer,
aircraft, or low pressure ground equipment and spot treatment by spreader.
Oryzalin was first registered for use in the United States in 1974. A Registration
Standard was issued in June, 1987 (NTIS# PB89-102396). Additional data were required in a
1991 Data Call-in Notice. Subsequent to issuing the Registration Standard, several
agricultural crops were deleted and the only food crops remaining on oryzalin labels are
berries, vine and orchard crops.
Reregistration Eligibility
The Agency has now completed its review of all generic data submitted on oryzalin in
response to the 1987 Registration Standard and the 1991 Data Call-in requirements. The
Agency has determined that all of the currently registered oryzalin products are eligible for
reregistration except for products labelled for use on residential lawns and turf. The Agency
does not have sufficient information to make an eligibility determination for residential lawn
and turf uses. In order to develop an adequate database to support this use, the Agency is
requiring that additional data be submitted.
Health Effects
The Agency has classified oryzalin as a group C carcinogen with a Qt* of
1.3 x 10"1 (mg/kg/day)"1. The Agency has a substantially complete database to assess dietary
risk and reassess existing tolerances for oryzalin. The dietary exposure data support the
reregistration of oryzalin for uses limited to berries, vine and orchard crops. A dietary risk
assessment has been conducted using tolerance data and anticipated residue data for oryzalin.
The chronic dietary exposure based on anticipated residue contribution (ARC) estimates are
less than l/5,000th of the RfD for each of the population groups and subgroups analyzed.
Based on the same data, the excess dietary carcinogenicity risk estimate for the U.S.
population is 8.1 x 10"7. When oryzalin tolerances are revoked for unregistered commodities,
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the upper bound cancer risk estimate is expected to be 4.5 x 10"7. Technical grade oryzalin
has been shown to be in toxicity category IV for acute oral toxicity and category III for acute
dermal and inhalation toxicity.
The qualitative nature of oryzalin residue in plants is adequately understood; the
terminal residues of concern in vine and orchard crops consist of unchanged oryzalin. Storage
stability studies (guideline 171-4e) are underway for apples and grapes and are considered
confirmatory to the existing storage.stability data on oryzalin. Oryzalin processed food/feed
studies for citrus and olives are also in progress and are considered confirmatory to the
existing evidence that residues of oryzalin do not significantly concentrate upon processing.
Occupational and Residential Exposure
Chronic post-application exposure from residential lawns treated with oryzalin by
professional landscape/lawn care personnel is of concern because oryzalin is a possible human
carcinogen and is persistent. The Agency does not have sufficient information available to
estimate post-application/reentry exposure for residential lawn and turf uses, and therefore,
could not conduct an exposure assessment for these uses for purposes of calculating risk.
Based on its cancer classification, the Agency is requiring that the Restricted Entry Interval
(REI) be increased to 24 hours instead of 12 hours. The REI applies to those uses within the
scope of the Worker Protection Standard (WPS). For occupational uses outside the scope of
WPS, the Agency is requiring that reentry be prohibited until sprays have dried and dusts have
settled. This reentry prohibition also applies to homeowner use products.
Because of the cancer classification and the oryzalin exposure assessment, active
ingredient based minimum Personal Protective Equipment (PPE) requirements are warranted
for all uses within the scope of WPS. In addition, products with non-WPS occupational uses
must also include the same PPE. Further, because of uncertainties regarding exposure to
homeowners and children following treatment, the Agency is requiring certain PPE for
homeowners who mix, load, and apply oryzalin to home lawns. These requirements are
outlined in Section IV and in Section V.
In addition, the Agency is requiring the following data for the reregistration of the
residential lawn use: foliar dislodgeable residues (guideline 132-la), soil dislodgeable residues
(guideline 132-lb), estimation of dermal exposure (guideline 133-3), and estimation of
inhalation exposure (133-4). These data will also be used to assess risks for commercial turf
use. These data are necessary to make an eligibility decision for these uses. Reentry
protection data for guidelines 132-la, 133-3, and 133-4 are also required for oryzalin use on
Christmas trees and field grown roses. Reentry data for Christmas trees and field grown roses
are considered confirmatory and these uses are eligible for reregistration.
The Agency is requiring mixer/loader/applicator studies (guideline 231: Estimation of
Dermal Exposure at Outdoor Sites, and guideline 232: Estimation of Inhalation Exposure at
Outdoor Sites). These data are required to refine the risk to private and commercial
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applicators using low-pressure handwand equipment, and will be considered confirmatory.
For the commercial applicator (M/L/A) using a low-pressure handwand, the estimated excess
cancer risk is 2.6 x 10"4 and for the private applicator, the risk is estimated to be 2.6 x 10~5.
Exposure below the knees is of particular concern with the use of the low-pressure handwand,
but the requirement for chemical resistant footwear will reduce exposure significantly.
Environmental Fate Assessment
The Agency has acceptable data on the mobility and dissipation route of parent
oryzalin, which appears to biodegrade slowly with a first half-life of approximately two
months. The submitted data on oryzalin suggest that parent oryzalin is not a groundwater or
surface water concern, and the Agency is not requiring ground or surface water advisories.
Parent oryzalin does not appear to be mobile under field conditions, however, it is expected
that a maximum of 10-20% of oryzalin degradates may leach.
DowElanco is currently conducting a mobility/adsorption/desorption study to determine
the mobility of nine oryzalin degradates, and to determine whether or not degradate leaching is
a major route of dissipation. This study is considered confirmatory and does not affect the
eligibility decision for oryzalin at this time. The Agency is reserving the requirement for
additional terrestrial field dissipation testing (guideline 164-1) until the results of the degradate
leaching study are submitted. If the degradates prove to be mobile, the Agency may either
require re-analysis of the field samples from the terrestrial field dissipation study, or require a
new field study.
Ecological Effects Assessment
The existing ecological effects data allow a preliminary risk characterization for acute
and chronic freshwater fish effects, acute invertebrate effects, acute avian effects and chronic
avian effects for single applications up to and including 4 Ib a.i./acre. From an acute toxicity
perspective, oryzalin is moderately toxic to freshwater fish and invertebrates and practically
nontoxic to birds.
Oryzalin poses a potential risk to endangered aquatic species that occur in shallow
regions of water. In shallow water (6 in.) adjacent to treated fields, the EECs exceed 0.05
LC50 values for all aquatic species tested and the Maximum Allowable Toxic Concentration
(MATC) value for the fathead minnow.
As expected for an herbicide, non-target plants may be adversely affected from runoff
and/or drift from the application of oryzalin at the labeled rates on all of the use sites.
Aerial applications of oryzalin ranging from minimum rates of 1.0 Ib a.i/A up to the
maximum label rate of 6.035 Ib a.i./A may pose a risk to nontarget plants. Because the EEC
values are greater than the EC^ values, oryzalin is expected to adversely affect terrestrial
plants including federally listed endangered and threatened plants.
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The Agency is requiring several ecological effects studies that will be considered
confirmatory for the reregistration of oryzalin. These data gaps do not affect the eligibility
decision for oryzalin at this time. Acute toxicity to estuarine/marine organisms - fish,
mollusk, and shrimp (guidelines 72-3a, 72-3b, and 72-3c) are required in order to assess the
effects of oryzalin on marine and estuarine organisms for the following use sites: berries,
citrus fruits, cherry trees, pecans, and golf course turf. Avian reproduction studies are
required as confirmatory data to assess chronic avian risk for single applications greater than 4
Ib a.i./A and multiple applications greater than 1.5 Ib a.i./A. A Daphnia life-cycle study is
required because oryzalin is expected to be transported to water from its intended use sites and
the EEC for a 6-foot deep pond is greater than 0.01 of the daphnid LC50. Droplet size
spectrum (201-1) and field drift studies (202-1) are needed to support ground spray, aerial
spray and air-blast application methods for oryzalin.
The technical producer of oryzalin has agreed to incorporate the following measures in
order to reduce environmental risks from oryzalin use. The registrant will eliminate all
airplane and helicopter applications of oryzalin except in California, where this use will be
restricted to agricultural crop labels only. In addition, this Reregistration Eligibility Decision
requires labelling changes to reflect the maximum amount of oryzalin that may be applied per
year, the maximum number of applications, and the interval between applications (see
Section V).
The Agency has determined that only the products containing oryzalin as the sole active
ingredient for the uses declared eligible for reregistration will be reregistered when acceptable
labeling and product specific data are submitted and/or cited. Before reregistering each
product containing oryzalin, 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.
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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 database underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential
hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether the pesticide
meets the "no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of oryzalin. The document consists of six sections. Section I is the
introduction. Section II describes oryzalin, 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 oryzalin. Section V
discusses the reregistration requirements for oryzalin. 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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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient(s) are covered by this Reregistration Eligibility
Decision:
• Common Name: Oryzalin
• Chemical Name: 3,5-dinitro-N4,N4-dipropylsulfanilamide
• Chemical Family: Dinitroaniline
• CAS Registry Number: 19044-88-3
• OPP Chemical Code: 104201
• Empirical Formula: C12H18N4O5S
• Trade and Other Names: Ryzelan, SURFLAN, EL-119
Basic Manufacturer:
DowElanco
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 these uses of oryzalin is in
Appendix A.
Type of Chemical: herbicide
Mode of Action:
2,6-Dinitroaniline herbicide, cell division inhibitor
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Use Groups and Sites:
TERRESTRIAL FOOD CROP
Nuts, pears, small fruits, stone fruits, subtropical fruits
TERRESTRIAL FOOD + FEED CROP
Citrus fruits, almonds, apples, grapes
TERRESTRIAL NONFOOD CROP
Christmas tree plantings; commercial/industrial and recreation area lawns; golf course
turf; nonagricultural rights-of-way/ fencerows/hedgerows; nonagricultural uncultivated
and industrial (outdoor) areas; ornamental and/or shade trees, herbaceous plants, and
woody shrubs and vines; power stations
TERRESTRIAL NONFOOD + OUTDOOR RESIDENTIAL
Ornamental and/or shade trees, herbaceous plants, lawns and turf, and woody shrubs
and vines; paths/patios; paved areas (private roads/sidewalks)
Pests: black nightshade, carpetweed, duckweed, climbing milk-weed, coast
fiddleneck, common mallow and purslane, several composite weeds, few cruciferous
weeds, desert rockpurslane, filaree, Florida pusley, many gramineous grasses, henbit,
ladys-thumb, lambsquarters, Mexican clover, Pennsylvania smartweed, prickly sida,
prostrate knotweed and spurge, pigweed, puncture-vine, tall morningglory, velvetleaf,
wiregrass, yardgrass
Formulation Types and Percent A.I. Ranges:
Granular—0.4 to 1% (may be formulated with other active ingredients)
Wettable powder-75%
Water dispersible granules—60 to 85 % (may be formulated with other active
ingredients)
Emulsifiable concentrate—2.84 to 40.4%
Flowable concentrate—40.4%
Formulation intermediate (manufacturing use)/liquid—40.4%
Methods and Rates of Application:
Granular
In any season, January through June, September through December, at nonbearing,
postemergence, containerized, foliar, or postplant stages, broadcast or spot treat by
spreader at 0.75 to 6 Ib AI/ acre.
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Wettable powder
At bearing or nonbearing stages, apply band treatment by low pressure ground
equipment at 6 Ib Al/acre. In any season, at bearing, nonbearing, foliar,
postemergence, or containerized stages, or when needed, spray by aircraft or low
pressure ground equipment at 0.75 to 6 Ib Al/acre.
Water dispersible granules
In any season, at bearing, nonbearing, postemergence, nonbearing nurserystock, foliar,
or containerized stages, or when needed, spray or apply band treatment by sprayer,
aircraft, or low-pressure ground equipment at 0.75 to 6 Ib Al/acre.
Emulsifiable concentrate
At bearing, nonbearing, or foliar stages, spray or apply band treatment by sprayer or
low-pressure ground equipment at 5 to 6 Ib Al/acre. At bearing or nonbearing stages,
apply chemigation treatment by sprinkler irrigation at 6 Ib Al/acre. In any season, at
foliar stage, or when needed, spray by hose-end, pressurized tank, or tank-type sprayer
at 6 to 8.5 gal product/acre.
Flowable concentrate
In any season, at nonbearing, postemergence, or containerized stages, or when needed,
spray by aircraft or low-pressure ground equipment at 0.75 to 4 Ib Al/acre.
Use Limitations:
Do not graze or feed forage from treated fields or orchards to livestock.
Estimated Usage of Pesticide
This section summarizes the best estimates available for the usage of oryzalin
on an aggregate and site (crop) basis. These preliminary estimates are derived from a
variety of published and proprietary sources available to the Agency. The range of
data presented accounts for annual fluctuations in use patterns as well as the variability
resulting from the use of data from various information sources. The table below
summarizes the amounts of oryzalin used by site.
-------
Table 1.
Typical Annual Usage (1991) and Percentage of various
US Crops Treated with Oryzalin
(November 1993)
Name of Site
ALMOND
APPLES
APRICOT
AVOCADO
BLACKBERRIES
BLUEBERRIES
CHERRIES
FIGS
GRAPES
GRAPEFRUIT
HAZELNUTS
LEMONS
ORANGES
OLIVES
NECTARINES
KIWI
PEACHES
PEARS
PLUMS /PRUNES
POMEGRANATES
PECANS
PISTACHIOS
RASPBERRIES
WALNUTS
TURF
TOTAL*'
Acres
Planted/
Harvested*
(000)
414
483
19
84
4
59
98
16
738
144
29
63
600
33
27
9
186
71
131
N.A.
453
52
11
180
17,000
20,904
Acres
Treatedb/
(000)
(Range)
145
24
6
1
0
1
15
2
295
1
0
1
6
10
14
4
9
4
13
0
68
26
0
9
340
994
166
48
8
1
0
3
20
3
443
1
0
1
60
13
16
5
37
14
26
0
91
31
1
27
850
1,865
Percentage
of Acres
Treatedc/
(Range)
35
5
30
<
<
1
15
15
40
<
<
1
1
30
50
40
5
5
10
50
15
50
1
5
2
40
10
40
1
1.
5
20 •
20
60
1
1
2
10
40
60
50
20
20
20
60
20
60
5
15
5
Active
Ingredientc/
(1000 Ibs
A.I.)
(Range)
300
40
5
2
<
1
20
2
100
<
<
5
20
10
15
2
20
20
40
1
5
30
1
25
800
1,467
350
90
10
3
1
2
25
5
200
1
1
10
75
15
20
5
75
25
75
2
35
40
2
50
800*
1,917
Percentage of
Total A.I.
(Range)
18.26
2.73
0.34
0.14
0.05
0.07
1.30
0.14
6.82
0.05
0.05
0.34
1.36
0.68
1.02
0.14
1.36
1.30
2.73
0.07
0.34
2.05 .
0.07
1.70
0.00
41.73
20.45
4.69
0.52
0.16
0.07
0.10
1.36
0.26
10.43
0.07
0.07
0.52
3.91
0.78
1.04
0.26
3.91'
1.36
3.91
0.10
1.83
2.09
0.10
2.61
0.00
54.53"
a/ Tnree years -1989-1991 or 1990-1992 average (with some 1987 data) when available is reported.
For perennial crops harvested acres are indicated, and for other crops planted acres are
reported.
b/ Acres treated are calculated from the percentages given in the immediately following two
columns. The lowest limit of the range is zero.
-------
c/ Sources: EPA Proprietary Sources; RFF. Herbicide Usage in the United States. December 1990;
State of California. Pesticide Use Report, Annual 1990; USDA. Agricultural Chemical Usage,
1991 Fruits and Nuts Summary. June 1992.
d/ No credible upper limit is available. The Agency is relatively certain about the lower limit
of turf a.i. which is about 0.8 million pounds. Hence, in view of the greater uncertainty of the
upper limit estimate, the grand total is presented including the lower limit turf a.i.
e/ Based on 0.8 million pounds a.i.
£/ Usage information about dewberries, gooseberries, loganberries, and non-food crops such as
ornamentals, and right of ways is not readily available. Oryzalin usage for ornamentals and
right of ways is considered to be a significant amount. The Agency is relatively certain for the
presented total usage, although individual crop usage could vary from the presented a.i.
estimates.
C. Data Requirements
Appendix B includes all data requirements identified by the Agency for
currently registered uses needed to support reregistration.
D. Regulatory History
Oryzalin was first registered in the United States in 1974 for use as a
preemergence herbicide in fruits, nuts, vineyards, orchards, forestry, noncrop areas
and agricultural crops. A Registration Standard for oryzalin was issued in 1987 which
evaluated the studies submitted to that date. A Data Call-in was issued in 1991 for
oryzalin requiring additional plant phytotoxicity data, plant and animal analytical
methods, and non-dietary exposure data. This Reregistration Eligibility Decision
reflects a reassessment of all data which were submitted hi response to the Registration
Standard and Data Call-in. There is currently one registered technical product, two
registered formulation intermediates and thirty-five end-use products.
-------
HI. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Technical oryzalin, 3,5-dinitro-N4,N4-dipropylsulfanilamide, is a
yellow-orange crystalline solid with a melting point of 141-142°C. Oryzalin is soluble
in water at 2.5 ppm at 25 C, and is readily soluble in organic solvents such as acetone,
ethanol, methanol, and acetonitrile. The molecular weight is 346.35 and the empirical
formula is C12H18N4O6S. The technical product is only slightly soluble in benzene and
xylene, and is insoluble in hexane.
All product chemistry data submitted in support of the reregistration of oryzalin
manufacturing-use products have been reviewed and found acceptable to fulfill 61-,
62-, and 63-series guideline requirements.
B. Human Health Assessment
1.
Toxicology
The toxicological data base is adequate and will support reregistration.
A dermal irritation study on Technical oryzalin is required as confirmatory
data.
-------
a. Acute Toxicity
Acute toxicity values and categories for oryzalin for technical
products are summarized below.
TEST
Oral LD50 - rat
Dermal LD50 - rabbit
Inhalation LC50 - rat
RESULTS
> 10 g/kg
> 2 g/kg
>3.17mg/L
CATEGORY
IV
m
III
Acute toxicity values and categories derived from oryzalin
Manufacturing-Use Products are summarized below.
TEST
Eye Irritation - rabbit
Dermal Sensitization -
guinea pig
RESULTS
slight damage
non-sensitizing
CATEGORY
III
Oryzalin was generally of moderate toxicity in acute studies. In
acute oral studies with rats, the LD50 was greater than 10 g/kg for
oryzalin in 5% acacia and greater than 5 g/kg for oryzalin in DMSO
(MRID# 00038668). The LD50 for oryzalin in acute dermal studies in
rabbits was more than 2000 mg/kg (category IE toxicity) (satisfies
guideline 81-2; MRID#s 00041970, 00106681). The LC50 value for
oryzalin (98%) in an acute inhalation study in rats was more than 3.17
mg/L (category ffl toxicity) (satisfies guideline 81-3; MRID#
41037201). Oryzalin, in a 5% acacia suspension, produced slight
corneal damage in the rabbit eye which cleared by day 7 (category III
toxicity) (satisfies guideline 81-4; MRID# 00106681). A dermal
irritation study is required for the Technical. No dermal sensitization
occurred with oryzalin in guinea pigs
(MRID# 00026762).
-------
b. Subchronic Toxicity
Three-month feeding studies with oryzalin were performed in
rats, mice, and dogs. In a study with Fischer 344 rats the doses were 0,
500, 900, 1600, 2750, or 4500 ppm. The LOEL was 2750 ppm (137.5
mg/kg/day) based upon the accumulation of heme pigment in the
kidneys. The NOEL was 1600 ppm (80 mg/kg/day) (satisfies guideline
82-2; MRID nos. 00026772, 00038677).
In a study with B6C3F1 mice, the doses were 0, 450, 900, 1800,
3650, or 8000 ppm. The LOEL was 8000 ppm (1200 mg/kg/day) due
to increased weights of several organs. The NOEL was 3650 ppm
(547.5 mg/kg/day) (satisfies guideline 82-1; MRID# 00026773).
In beagle dogs, the doses given by capsule were 0, 6.25, 18.75,
or 56.25 mg/kg/day. The LOEL was 56.25 mg/kg/day as a result of
reductions in red cell, hematocrit and hemoglobin levels, increases in
blood urea nitrogen, alkaline phosphatase, sedimentation rate, glucose,
and SGPT levels, and hyperplastic bone marrow and hepatocellular
changes. The NOEL in dogs was 18.75 mg/kg/day.
(MRID# 00106670).
c. Chronic Toxicity
In a combined chronic toxicity/carcinogenicity study, oryzalin
was fed to Fischer 344 rats for two years at doses of 0, 300, 900, or
2700 ppm. The study resulted in a systemic toxicity NOEL of 300 ppm
(13.82 mg/kg/day for females; 12.16 mg/kg/day for males). The
systemic LOEL for females was 900 pprn (42.89 mg/kg/day) based upon
hematologic changes (decreased red cells, hemoglobin and hematocrit)
and organ weight changes (increased liver and kidney weights) seen in
both sexes at 900 ppm (42.89 mg/kg/day for females; 36.86 mg/kg/day
for males). There were also, at the high dose, reduced survival,
reduced body weight and weight gain, reduced feed efficiency in the
females, increased thyroid weight, and histopathological changes in the
thyroid (satisfies guidelines 83-1 and 83-2; MRID# 00044332).
Beagle dogs were given, by capsule, doses of 0, 1.5, 5, 15 (later
250 and 500) or 50 mg/kg/day of 98.9% oryzalin for a period of one
year. The systemic toxicity NOEL was determined to be 50 mg/kg/day.
At the 250 and 500 mg/kg/day dosages (LOEL) there were decreased
RBC count, hematocrit, and hemoglobin; increased serum cholesterol,
decreased alanine transaminase, increased liver and kidney weights, and
-------
decreased adrenal weights. There was an effect on thyroid function at
250 mg/kg/day but not at 50 mg/kg/day (satisfies guideline 83-1;
MRID# 40024801).
d. Carcinogenicity
Long-term studies in rats and mice have been performed to
evaluate the potential carcinogenic activity of oryzalin. Oryzalin was
not carcinogenic in a two-year B6C3F1 mouse study in which feeding
levels of the compound were 0, 500, 1350, or 3650 ppm. The NOEL
for systemic toxicity was 1350 ppm (192.9 mg/kg/day). The LOEL was
3650 ppm (521.4 mg/kg/day) as a result of decreased body weight gain
in females and males (satisfies guidelines 83-1 and 83-2; MRID nos.
00026780, 00068079).
Oryzalin was found to be carcinogenic in rats based on the
increased incidence of mammary gland tumors in females and skin and
thyroid tumors in both sexes. Carcinogenic effects were observed at 300
ppm (15 mg/kg/day) due to the occurrence of mammary gland tumors in
females and skin and thyroid tumors in both sexes. Oryzalin is classified
as a group C carcinogen with a Qx* of 1.3 x 10"1 (mg/kg/day)"1, based
on the mammary gland tumors.
(MRID# 00044332)
e. Developmental Toxicity
In pregnant CD rats gavaged with 0, 50, 225, or 1000 mg/kg/day
of oryzalin on gestation days 6 to 17, the maternal toxicity NOEL was
50 mg/kg/day. The maternal LOEL was 225 mg/kg/day based upon
reduced body weight gain and food consumption. The developmental
toxicity NOEL was 50 mg/kg/day. The developmental LOEL was 225
mg/kg/day based on decreased mean fetal body weights, an increased
incidence of runts, and an increased incidence of incomplete ossification
of the forepaw metacarpal bones (study satisfies guideline 83-3; MRID#
41163801).
When pregnant Dutch belted rabbits were gavaged with 0, 25,
55, or 125 mg/kg/day of oryzalin on gestation days 6 to 18, the maternal
toxicity NOEL was 25 mg/kg/day. The LOEL was 55 mg/kg/day due
to decreased food consumption and weight gain. The developmental
toxicity NOEL was also 25 mg/kg/day. The developmental LOEL of 55
10
-------
mg/kg/day was based on increased resorptions, increased post-
implantation loss, and reduced mean litter size (MRID# 00026785).
Another study in pregnant Dutch belted rabbits used gavage doses
of 0, 10, 25, 55, or 125 mg/kg/da.y on gestation days 6 through 18. The
maternal toxicity NOEL was 25 mg/kg/day. The maternal LOEL was
55 mg/kg/day based on reduced food consumption. There was no
evidence of developmental toxicity in this study and the developmental
NOEL was equal to or greater than the highest dose, 125 mg/kg/day.
Although these two studies do not satisfy the guidelines individually,
these two rabbit studies combined satisfy guideline 83-3 (MRID#
00098461).
f. Reproduction
Dietary doses of 0, 250, 750, or 2250 ppm (12.5, 37.5, or 112.5
mg/kg/day) were given in a three-generation study with Fischer 344
rats. The reproductive NOEL was 2250 ppm (112.5 mg/kg/day, highest
dose tested) or greater. The fetotoxic NOEL was 12.5 mg/kg/day,
based upon depressed pup growth at 37.5 mg/kg/day. (MRID#s
00026786, 00038564).
An additional one-generation study was performed in Fischer 344
rats using dietary concentrations of oryzalin of 0, 0.025, 0.075, or
0.225% (equivalent to 0, 25, 75 or 225 ppm of the diet) in order to
supplement the three-generation study. The reproductive NOEL was
0.225% or higher (178.8 mg/kg/day in males, 205.5 mg/kg/day in
females). The systemic toxicity LOEL was 0.025% or lower (19.4
mg/kg/day in males, 22.3 mg/kg/day in females) based on increased
liver and kidney weights plus the presence of bilateral cortical tubular
hyaline droplets. In addition, clinical signs were noted in the mid and
high dose groups. There were decreased body weight gain and food
consumption in high dose males and females of both generations. Mid-
dose females showed decreased weight gain, too. Although each
reproduction study does not satisfy the guidelines separately, these two
rat studies combined satisfy guideline 83-4 (MRID# 42401501).
g. Mutagenicity
Oryzalin was not mutagenic in tests for gene mutations, such as
the Ames test using several strains of S. typhimurium and the WP2
strain of E. coli (MRID hos. 00130427, 41050101 and
11
-------
41289901). In tests for structural chromosome aberrations, oryzalin
produced negative results in a rat dominant lethal study (MRID#
00115743). Oryzalin did not induce sister chromatid exchange in
Chinese hamster bone marrow cells following oral administration
whereas induction was observed following intraperitoneal injection
(MRID# 00086801). In tests for other genotoxic effects, oryzalin was
negative in an unscheduled DNA synthesis test in rat hepatocytes
(MRID# 00086801). (These studies fulfill guidelines 84-2 and 84-4).
h. Metabolism
The Agency presently has adequate information on the
metabolism of oryzalin and has waived the data requirement 85-1,
General Metabolism. However, the Agency reserves the right to require
this study in the future if oryzalin metabolites are detected in plant
and/or animal residues or if the study is needed to clarify issues of
toxicity and/or carcinogenicity of oryzalin.
i. Dermal Absorption
A dermal absorption study in monkeys indicated that 2.3% of the
dermally applied oryzalin is absorbed through the skin. This absorption
value is used for assessing human risk following dermal exposure
(MRID#s 42784102, 43207001).
j. Reference Dose (RfD) (for Chronic Oral Exposure)
The reference dose for oryzalin was determined to be 0.12
mg/kg/day, based on the chronic feeding study with rats in which the
NOEL was 12.16 mg/kg/day. An uncertainty factor of 100 was used to
account for differences between species and variability between humans
(00070569, 00026779, 00044332).
The Joint FAO/WHO Meeting on Pesticide Residues (JMPR) has
not issued an ADI for oryzalin to date.
12
-------
2. Exposure Assessment
a. Dietary Exposure
The residue chemistry data necessary to assess dietary exposure
and reassess existing tolerances are substantially complete. The dietary
exposure data support the reregistration of oryzalin for uses limited to
vine and orchard crops. Additional data on storage stability and
processed citrus and olives are required as confirmatory data.
GLN 171-4 (a): Plant Metabolism: The qualitative nature of the
residue in berries, vine and orchard crops is adequately understood. The
residue of concern in plants is the parent, oryzalin. The submitted grape
metabolism studies indicated that there was little uptake or translocation of
oryzalin from the soil; no oryzalin or oryzalin-related compounds were
identified. Grapes are representative of the crops (berries, vine and orchard) on
which oryzalin is registered currently for use; therefore, only one plant
metabolism study, with grapes, was required to satisfy plant metabolism data
requirements. In the event an interested party wishes to obtain registration for
use of oryzalin on crops other than berries, vine or orchard crops, additional
plant metabolism data will be required. 1'he residue of concern in plants is
oryzalin, which is the residue presently included in the tolerance expression.
(MRID#s 42558201, 43060001)
GLN 171-4 (b): Animal Metabolism: The qualitative nature of the
residue in ruminants and poultry is adequately understood. Studies conducted at
highly exaggerated feeding levels with laying hens and beef and dairy cattle
indicated that oryzalin is either poorly absorbed or rapidly metabolized via
hydroxylation and cleavage of the alkyl side chain to yield polar components
that are excreted. The parent compound was identified only in eggs, in minor
quantities (<0.01 ppm). Since it is unlikely that detectable residues of oryzalin
would occur in animal commodities at a Ix feeding level, this is considered to
be a 40 CFR 180.6 category 3: "No reasonable expectation of finite residues in
animal commodities", with respect to tolerances for residues in meat, milk,
poultry and eggs. (MRID#s 42064901 and 42158502)
GLN 171-4 (c/d): Residue Analytical Methods - Plants/Animals: An
adequate method is listed in the FDA Pesticide Analytical Manual (PAM Vol.
II) for purposes of data collection and enforcement of tolerances for residues of
oryzalin. Method I is a GLC/electron capture detection (BCD) method and
involves conversion of oryzalin to its AT^r-dimethyl derivative with methyl
iodide. The detection limit for the method is 0.01 ppm for plant commodities.
Modifications of Method I using GLC/ECD or HPLC are adequate for purposes
13
-------
of data collection for residues of oryzalin in animal commodities; the detection
limit is 0.05 ppm for these modified methods. Enforcement methodology for
residues of oryzalin in animal commodities is not required at this time since
finite residues of oryzalin are not likely to be present in animal commodities at
detectable levels. (MRID#s 00023990, 00033976, 00106730, 41630302,
42064903, and 42064904)
The registrant has submitted data (1989; MRID# 41197001) pertaining
to the analysis of oryzalin using PAM Vol. I FDA Multiresidue Protocols D
and E for fatty and non-fatty foods; these data have been forwarded to the FDA
for review.
GLN 171-4 (e): Storage Stability: Storage stability studies have been
conducted using fortified samples of apples, apple processed commodities,
pears, blueberries, grapes, grape processed commodities, and raspberries.
Residues of oryzalin are stable under frozen storage conditions (-200 C) in/on
apples, apple juice and pomace, grapes, grape juice, pomace, and raisins,
pears, and raspberries for up to ca. 70 days, in/on blueberries for up to 95
days, and in/on soybeans for up to 9 months. Storage stability data for apples
may be translated to pears, citrus fruits, stone fruits, figs, kiwifruit, and
pomegranates. Storage stability data for soybeans may be translated to tree
nuts, avocados, olives, and pistachios. Additional storage stability studies with
apples and grapes have been required and are currently in progress. These data
are considered confirmatory to the existing storage stability data which provide
preliminary evidence that oryzalin residues are stable in frozen plant matrices
for the storage intervals of residue samples used for tolerance reassessment.
(MRID#s 00106730 and 41630301)
GLN 171-4 (k): Magnitude of the Residue in Plants: All magnitude of
the residue data in food/feed crops which are presently supported have been
evaluated and deemed adequate to reassess the 0.05 pprn tolerances for residues
of oryzalin. The crop field residue data requirements for apples, pears,
grapes, and rubus (caneberries) reflecting use of a WP or DF formulation were
waived, because the AS (aqueous suspension) formulation used in previous
studies was sufficiently representative of a WP or DF formulation. (MRID#s
00031663, 00106691, 41115501, 41733701, 41906001, 41906004, 41906005,
41906006, and 42050001)
GLN 171-4 (1): Processed Food/Feed: Except for citrus and olives, the
magnitude of the residue data for processed commodities of presently supported
food/feed crops have been evaluated and deemed adequate. Additional
processing studies for citrus and olives have been required and are currently in
progress. These data are considered confirmatory to the existing evidence that
14
-------
residues of oryzalin do not significantly concentrate upon processing. (MRID#s
00031663, 00106691, 41906002, and 41906003)
GLN 171-4 (j): Magnitude of the Residue in Meat, Milk, Poultry and
Eggs: The ruminant and poultry metabolism studies indicate that finite residues
of oryzalin are not likely to be present in eggs, poultry tissues, milk, and
ruminant tissues at detectable (>0.05 ppm) levels. The use of oryzalin on
livestock feed commodities is considered to be a 40 CFR 180.6 Category 3 with
respect to tolerances for residues in meat, milk, poultry, and eggs, Thus,
conventional livestock feeding studies and tolerances for oryzalin in meat, milk,
poultry, and eggs will not be needed provided that: (i) tolerances for residues
of oryzalin in/on soybeans, cottonseed, barley grain, wheat grain, potatoes, and
peas (succulent), which no longer have registered uses, are revoked; and (ii) the
required citrus processing study does not indicate concentration such that the
theoretical dietary intake of -0.03 ppm for beef and dairy cattle exceeds feeding
levels utilized in the ruminant metabolism studies.
GLNs 165-1 and 165-2: Confined/Field Rotational Crops: These
requirements have been waived since food uses of oryzalin are for berries, vine
and orchard crops only, which are not rotated.
Currently, grazing and feeding restrictions appear on the 4 Ib/gal EC
and 75% WP, but not on the 85% DF labels. All end-use product labels must
be amended to include a restriction against grazing or feeding crops grown in
treated areas to livestock. In addition, all end-use product labels (e.g. multiple
active ingredient, state and local needs, and products subject to generic data
exemption) must be amended such that they are consistent with the basic
producer labels.
Codex Harmonization
There are no proposed or established Codex MRLs (Maximum Residue
Limits) for residues of oryzalin in/on food/feed items; therefore, there are no
compatibility questions with respect to U.S. tolerances and Codex MRLs.
b. Occupational and Residential Exposure
Mixer/Loader/Applicator (Handler) Exposure
Mixer/loader/applicator (i.e., handler) exposure issues are
addressed by Subdivision U of the Pesticide Assessment Guidelines.
Mixer/loader/applicator exposure monitoring data were not required in
the Registration Standard for Oryzalin. However, chemical specific
mixer/loader/applicator data (MRID# 42137901) have been submitted to
15
-------
EPA. The initial evaluation of MRID# 42137901 indicates insufficient
replicates were generated under Subdivision U Guidelines. Therefore,
the chemical specific data from MRID# 42137901 were combined with
the surrogate study MRID# 42974501 and the Pesticide Handlers
Exposure Database (PHED) for a limited exposure/risk assessment.
However, additional mixer/loader/applicator data are required in order
to estimate dermal and inhalation exposure with the use of the low-
pressure handwand.
Based on the use patterns described above, seven major exposure
scenarios were identified, including groundboom tractors, chemigation,
backpack, low pressure handwands, tractor drawn solid broadcast
spreaders, manually operated broadcast spreaders (i.e., hand-pushed),
and whirly-bird spreaders. The exposure scenarios for private and
commercial applicators and the daily dose appropriate for use in an
"intermediate term" risk assessment are summarized in Tables 2, 3,
and 4.
16
-------
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-------
Table 3. Exposure Scenario Descriptions for Oryzalin
Exposure
Scenario
(Seen. #)
Open Mixing
Granulars (I)
Open Mixing (II)
Solid Broadcast-
Tractor (HI)
Solid Broadcast -
Push Typo (IV)
Chemigation (V)
Groundboom
Application (VI)
Backpack/
Knapsack (VII)
Data
Source
PHED
PHED
Clothing
Scenario
Total Deposition
Long Pants, Long-
Sleeved Shirt,
No gloves
No Data
No Data
No Data
PHED
421379-01
429745-01
PHED
No Data
No Data
No Data
Long Pants,
Long-Sleeved
Shirt, No gloves
Long Pants, Long-
Sleeved Shirt,
Gloves
Equipment
Standard
Assumptions'1
(8 hr work day)
Mixer/Loader Exposure
Open Mixing
Open Mixing
Forty 50 lb. bags
80 acres @ 6 lb ai/A
(Groundboom)
Comments0
All grades;
Dermal = 3 to 14 replicates;
Inhalation = 14 replicates.
Acceptable grades;
Dermal = 14 + replicates;
Inhalation = 40 replicates.
Applicator Exposure
No Data
No Data
No Data
Open Cab Tractor
2 gallon Knapsack
No Data
No Data
No Data
80 acres/day
2 acres/day
No Data
No Data
No Data
All grades;
Dermal = 6 to 99 replicates;
Inhalation = 102 replicates.
Inhalation grade B; Dermal grade
B; Hand grade C
Dermal = 9 replicates;
Inhalation = 9 replicates.
Mixer/Loader/Applicator
Solid Broadcast -
Whlrly Bird (Vffl)
Low Pressure
Handwand (IX)
PHED
PHED
Long Pants, Long
Sleeve Shirt,
Gloves
Long Pants, Long-
Sleeved Shirt, No
Gloves
Whirly Bird/Belly
Grinder
Portable handwand
1 Acre/Day
2 acres/day
Inhalation grade E; Dermal
grades C and E;
Dermal = 16 to 20 replicates;
Inhalation = 18 replicates.
Inhalation grades B and C;
Dermal all grades; Dermal = 25
to 95 replicates; Inhalation = 95
replicates.
"No Data" indicates that no data were available to complete an exposure assessment
Standard Assumptions based on an 8 hour work day.
If dermal and inhalation grades are not listed separately, then the listed grades pertain to both dermal and inhalation. "Acceptable grades,"
as defined for meeting Subdivision U Guidelines, are grades A and B for dermal and inhalation, and grade C for hand rinse method. All
grades that do not meet the Agency's SOP are listed individually.
18
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Table 4. Intermediate Oryzalin Exposure (greater than one week) for
Commercial Applicators (Combined Dermal and Inhalation Exposure)
Exposure Scenario
(Seen. #)
Total Daily Dosea
(mg/kg/day)
Mixer/Loader
Open Mixing Granulars (I)
Open Mixing Liquids (II)
0.0008
0.027
Applicators
Solid Broadcast-Tractor (in)
Solid Broadcast-Push Type (IV)
Chemigation (V)
Groundboom Application (VI)
Backpack (VE)
No Data
No Data
No Data
0.010
0.008
Mixer/Loader/Applicator
Solid Broadcast-Whirly Bird (VIII)
Low Pressure Handwand (IX)
0.064
0.149
" See Table 1 for calculations.
b The dermal dose was adjusted for a 60 kg individual.
The available PHED exposure estimates were based on the following clothing scenario:
coveralls over long pants, long-sleeved shirt, and chemical resistant gloves. Protection factors
were applied to the PHED data to simulate appropriate clothing (see Table 3 for the actual
exposure clothing scenarios). Based on the results of the exposure assessment, and because this
chemical is a possible human carcinogen the following handler PPE are required for oryzalin:
• coveralls over long-sleeved shirt and long pants
• chemical-resistant gloves
• chemical-resistant footwear
• chemical-resistant headgear for overhead exposures
Mixers and loaders must also wear a chemical-resistant apron.
19
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Postapplication/Reentry Exposure (Workers) :
Based on its cancer classification, oryzalin meets the Agency's toxicity criteria for
requiring reentry data. For some scenarios, oryzalin also meets the Agency's exposure criteria
(substantial contact with treated foliage/surfaces). There are no reentry data available for use in
an exposure assessment for calculating a Restricted Entry Interval. Reentry data are required for
applications to Christmas trees and field-grown roses. These data requirements are specified in
PartlV. For agricultural and ornamental crops, an REI of 24 hours is required instead of the 12
hour REI that has been imposed by the Worker Protection Standard (WPS).
Orchard. Vineyard and Ornamental Crops:
Postapplication harvester exposure is not expected after directed soil applications because
the foliage is not treated. However, limited postapplication exposure during pruning activities can
be expected following overtop treatments to dormant orchards or vineyards using chemigation
equipment. These exposures are expected to be low since there is no treated foliage at that time.
Due to contact with treated branches and because this chemical is a possible human carcinogen,
the Agency is requiring a 24 hour REI.
Established Turf (warm-season turfgrasses) :
Residential lawns are treated with oryzalin by professional landscape/lawn care personnel
and certain products are available for use by the homeowner. Chronic postapplication exposure
from these applications is of concern because oryzalin is a possible human carcinogen and
persistent. There is a potential for continued, substantial contact with treated surfaces, particularly
among children. There are no data to evaluate potential exposure to turfgrass, and therefore the
safety of this use cannot be evaluated. Data are required to support this use and are specified in
Part IV of this document.
For golf courses and residential turf uses, the following entry restriction is required:
• for the liquid applications: a prohibition on entry until the sprays have dried;
• for dry applications: a prohibition on entry until dusts have settled;
Non-WPS Uses (includes both occupational and non-occupational):
The Agency requires that the entry restriction for all non-WPS uses
of oryzalin be the following:
• for the liquid applications: a prohibition on entry until the sprays have dried;
• for dry applications: a prohibition on entry until dusts have settled.
20
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Data for Other Uses:
Data are not required for the remaining uses for which no data are available. The Agency
believes these uses represent lower exposure potential than those uses for which data were
available.
3.
Risk Assessment
Toxicological Endpoints
The reference dose for oryzalin was determined to be 0.12 mg/kg/day, based on the
chronic feeding study with rats in which the NOEL was 12.16 mg/kg/day. An uncertainty factor
of 100 was used to account for differences between species and variability between humans
(MRID#s 00070569, 00026779, 00044332).
Oryzalin was found to be carcinogenic in rats, based on increased incidences of mammary
gland tumors in females and of skin and thyroid tumors in both sexes. Oryzalin is classified as a
group C carcinogen with a Q t* of 1.3 x 10'1 (mg/kg/day)"1, based on mammary gland tumors.
Subchronic toxicological endpoints from a 3-generaition reproduction study in the rat (83-
4), (MRID#s 00026786, 00042908), indicated that risk assessment is required for occupational
and residential exposure of 1 week to several months. A fetotoxic NOEL of 12.5 mg/kg/day was
observed. The LOEL (depressed pup growth) was 37.5 mg/kg/day.
Dietary Risk
Sufficient tolerance data and anticipated residue data are available to conduct a dietary
risk assessment. The chronic dietary exposure based on anticipated residue contribution (ARC)
estimates are very low-less than l/5,000th of the RfD for each of the groups and subgroups
analyzed in the DRES analyses. Based on the same data, the dietary excess carcinogenicity risk
estimate for the U.S. population is 8.1 x 10 ~7. The upper bound excess cancer risk estimate is
expected to be even lower (4.5 x 10 "7) when tolerances are revoked for unregistered commodities.
Occupational and Residential Risk
Oryzalin is used by both private and commercial applicators. Private applicators are
exposed typically once a year (considered a "short term" exposed individual); commercial
applicators are exposed typically 10 times a year (considered an "intermediate term" exposed
individual).
21
-------
Lifetime Average Daily Dose (LADD) (mg/kg/day) = Total Daily Dose (from Table 4)
(mg/kg/day) x (Work Days Per Yr/365 Days) x (35 Yrs/70 Yrs)
Excess cancer risk to workers may be estimated by the following equation:
Excess Cancer Risk = Total LADD (mg/kg/day) (Total Dermal + Inhalation) x Q1
where,
Q! = 0.13 (mg/kg/day)"1
The summary risk values are given in Table 5. Low pressure handwand application has
the highest exposure potential of all of the exposure scenarios. The private applicator (M/L/A)
using a low pressure handwand has an estimated excess cancer risk of 2.6 x 10 "5. The commercial
applicator (M/L/A) using the same handwand equipment has the greatest estimated excess cancer
risk, at 2.6 x 10"4. There are no data for applicator exposure using solid broadcast (tractor or
push type) or chemigation. However, these uses are expected to present lower exposure
potentials than the others listed in the preceding tables.
For the low pressure handwand spray, the additional use of chemical resistant footwear
and coveralls will serve as risk mitigation measures since exposure below the knees is significant
during this application scenario. Mixer/loader/applicator data are required to support the
reregistration of this use. Because the Agency believes that the exposure estimate is conservative
and the chemical resistant footwear should adequately mitigate risk, these data will be considered
confirmatory. In addition, chemical resistant footwear is being required for all uses including
those within the scope and those outside the scope of the Worker Protection Standard.
22
-------
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Because commercial applicators are exposed 1 week or more in a year, they may
potentially be at risk for systemic toxicity. The margin of exposure (MOE) may be calculated
from the following equation:
MOE = NOEL/Total Daily Dose (mg/kg/day)
NOEL = 12.5 mg/kg/day
Table 6. Risk from Intermediate Exposure for Commercial Applicators of Oryzalin
Exposure Scenario
(Seen. #)
Total Daily Dose
(mg/kg/day)
Mixer/Loader
Open Mixing Granulars (I)
Open Mixing Liquids (II)
0.0008
0.027
Dermal MOE
Commercial
15,600
460
Applicators
Solid Broadcast-Tractor (IE)
Solid Broadcast-Push Type (IV)
Chemigation (V)
Groundboom Application (VI)
Backpack (VII)
No Data
No Data
No Data
0.010
0.008
No Data
No Data
No Data
1200
1600
Mixer/Loader/Applicator
Solid Broadcast-Whirly Bird (VTH)
Low Pressure Handwand (DC)
0.064
0.149
200
84
* The dermal dose was adjusted for a 60 kg individual.
C. Environmental Assessment
1. Environmental Fate
a. Environmental Chemistry, Fate and Transport
24
-------
161-1. Hydrolysis:
Based upon data from acceptable studies, oiyzalin is stable to hydrolysis at pH's 5, 7, and
9. However, oryzalin has a pKa of 8.6 (Helling, 1976, published literature) and is more than
50% deprotonated (removal of hydrogen from the sulfariilamide group) at pH 9. (3VIRID
41378401; acceptable)
161-2. Photodegradation in Water:
Oryzalin can photolyze with a half life of 5 hours in aqueous solution (pH 5, (2.47 ppm) at
25°C). The aqueous solution was exposed to a Xenon arc lamp for 12 hours. Identified
aqueous photoproducts include:
3-nitro-5-aminosulfanilamide (2.9%),
3-nitro-5-amino-N-propylsulfanilamide (OR-5, 4.0%),
3,5-dinitro-sulfanilamide (OR-3, 5.7%), and
2-ethyl-7-nitro-l-propyl-5-sulfonylaminobenzimidazole3-oxide(14%).
The calculated first-order photodegradation half-life of oryzalin was 2.3 artificial hours or
1.4 sunlight hours. Oryzalin remained relatively stable in the dark control. (MRED #41278701,
supplemental information; acceptable)
161-3 Photodegradation on Soil:
Oryzalin applied to sandy loam soil and irradiated for 61 hours with a xenon lamp
degraded with biphasic kinetics. The biphasic photolysis half-life observed on soil is somewhat
longer than the first-order half-life in aqueous solution. A linear regression of the initial phase
(hours 0 through 13.0) line resulted in a half-life of 22.4 hours. Identified photoproducts in soil
include:
3,5-dinitro-4-amino-sulfanilamide (OR-3, 2.6%),
2-ethyl-7-nitro-5-sulfamoyl benzimidazole (OR-15, 3.2%) and
3,5-dinitro-N,N-dipropyl sulfanilic acid (OR-21, 4.6%).
After 61 hours of radiation, 14.5% of the applied was bound to the soil. Approximately
35% of the applied material appears to have been left unresolved by the two HPLC systems
used in this study.
25
-------
Degradation of oryzalin in the dark control was not substantial enough to calculate a half-
life. (MDRJD 41050001; acceptable)
162-1 Aerobic Soil Metabolism:
In aerobic soil, oryzalin exhibited an average overall half-life of 2.1 months at 24 ° C. The
major degradate was 4-Hydroxy-3,5-dinitro-benzenesulfonamide (OR-20),
which accounted for a maximum of 4.7% of 0 time radioactivity at 1 month post-treatment.
Eight other degradates were isolated, each accounting for < 2.4% of the applied radioactivity.
The benzenesulfonamide ring remained intact in all of the identified metabolites. By the end of
the experiment at 6.1 months, 63.1% of the applied radioactivity was nonextractable and 5.7%
had been mineralized to CO2. (MRID 41322801; acceptable)
162-2 Anaerobic Soil Metabolism:
Oryzalin degraded with a 10 day half-life when anaerobic conditions were established after
23 days of aerobic incubation at 28 °C in sandy loam soil. By the end of the experiment at 6.1
months, 63.1% of the applied radioactivity was nonextractable.
An initial half-life of 1.2 months was calculated for the first 7 data points of the biphasic
curve (first 2 months of the study) and a 3 month half-life was calculated for the last 4 data
points of the curve (last 4 months of the study).
The major degradates formed during the anaerobic incubation were several
benzeneimidazoles with a reduced nitro group and smaller amounts of benzenesulfonamides
with 1 or 2 nitro groups reducing to amines. Gingerich and Zimdahl (1979, published literature)
suggest that a highly oxidized parent compound like oryzalin will degrade more rapidly under
reducing than under oxidizing conditions, and the submitted data is consistent with the oryzalin
half-lives measured in the Gingerich and Zimdahl study.
Oryzalin accounted for 62.3% of the applied radioactivity after 23 days of the initial
aerobic incubation in sandy loam soil. The major degradates formed during the aerobic
incubation were:
4-hydroxy-3,5-dinitrobenzenesulfonamide;
2-ethyl-7-nitro-l-propyl-lH-benziniidazole-5-sulfonamide,3-oxide;
3,3l-azoxybis[4-(propylamino)-5-nitro]benzenesulfonamide; and
3,5-dinitro-4-(propylamino) benzenesulfonamide
26
-------
which were present in 4.7, 2.4, 1.4, and 1.2% respectively of 0 time radioactivity. After
conversion to anaerobic conditions these aerobic metabolites (at 30 and 60 day samples) each
accounted for < 0.2% 0 time radioactivity. At 60 days of anaerobic incubation 1.0% of 0 time
radioactivity remained as oryzalin. (MRID 413228-02; acceptable)
163-1 Mobilitv/Adsorption/Desorption;
Unaged batch equilibrium
Uniformly ring-labeled 14C oryzalin solutions at 1.0, 0.2, 0.04, 0.008 ug/ml in CaCl2 were
equilibrated for 22 hours at 25 ° C in a sandy loam (O.M. 1.4%, pH 5.7, CEC 4.9 meq/lOOg), a
loam (O.M. 1.8%, pH 6.5, CEC 10.5 meq/lOOg) and a day loam soil (O.M. 2.0%, pH 6.9, CEC
21.2 meq/lOOg). The results suggest that oryzalin may be moderately mobile:
Unaged Batch Equilibrium: (at 1 meg/ml)
Soil
Type
sand
sandy loam
loam
clay loam
*Q(ads)
2.1
4.9
8.4
12.9
**-d(des)
1.3
1.9
2.3
2.6
%OM
_
1.4
1.8
2.0
* Ad/des values were an average of three replicates.
Total recoveries from all extractions ranged from 89.2% to 105.5%. Oryzalin was stable
throughout the experiment as confirmed by thin layer chromatography (TLC).
Jacques and Harvey (1979a, published literature) showed that oryzalin adsorption was
more strongly correlated to the amount of organic matter in the soil than to any other soil
feature, with an r value of .95. They also showed that unlike other dinitroaniline herbicides,
which diffuse as vapors through dry soil, oryzalin diffused most rapidly when the soil was wet
(48.8% weight/weight wetness). This suggests that oryzalin would be most mobile in coarse,
wet, alkaline soils with little organic matter. Helling (1976, published literature) confirms that,
although oryzalin is not especially mobile, "oryzalin leaching was greater when the soil was
initially moist rather than dry."
(MRID# 41479802, additional supporting data; acceptable; MRID 41479801; supplemental)
27
-------
Aged Soil Column Leaching:
Potential mobility of oryzalin degradates is not well understood. Mobile degradates that
degrade further and then bind irreversibly in the closed laboratory system may leach before the
additional biodegradation and soil binding can occur in the field.
Oryzalin aged in sandy loam soil at 25°C + 1°C for 30 days was leached from a loam soil
(sieved through 2mm mesh) with 0.01 M CaCl2. In the soil column leaching experiment, 2.9-
3.9% of total applied radioactivity was found in the leachate. Greater than 50% of the
radioactivity found in the leachate was 4-hydroxy-3,5-dinitro-benzenesulfonamide. It is not clear
whether leaching of 4-hydroxy-3,5-dinitro-benzenesulfonamide and other oryzalin degradates
could represent a significant route of oryzalin dissipation in the field. Oryzalin comprised 0.3-
0.6% of radioactivity found in the leachate from the loam soil.
Aged Adsorption/Desorption (Batch Equilibrium) Data :
The registrant has offered to submit additional aged oryzalin desorption data on three soils
to provide information on the mobility of the 9 metabolites identified in the aerobic soil
metabolism (162-1) study. The Agency has already reviewed a protocol for this study.
However, the Agency has also recommended that the registrant complete an
adsorption/desorption study on the major aerobic soil biodegradate, 4-Hydroxy-3,5-dinitro-
benzenesulfonamide.
164-1: Terrestrial Field Dissipation:
The terrestrial field dissipation data are inconclusive at this time because they provide no
information about the dissipation route of oryzalin but merely indicate its rate of disappearance.
While it is true that no single degradate in the aerobic soil metabolism study comprised more
than 4.7% of the applied radioactivity, all of the reported degradates retained the
benzenesulfonamide structure. It may be possible to monitor this structure, if not the individual
degradates in the field. Data on the mobility of oryzalin degradates (proposed study discussed
below) has not yet been received, and it is not possible at this time to judge whether oryzalin
dissipation in the field is due solely to biodegradation or whether oryzalin degradates might
leach before further biodegradation occurs.
Oryzalin demonstrated moderate persistence with a first order half life of 68 days in sand
soil in Florida and biphasic degradation in Michigan and California. First phase half-lives were
77 days in silty clay loam in Michigan and, 58 days in loam soil in California, while second phase
half lives were 146 days in Michigan and 138 days in California. This approximates the aerobic
soil half-life observed in the laboratory, and appears to rule out photodegradation and
anaerobiosis as major field processes for typical uses of oryzalin. Biphasic field dissipation of
28
-------
oryzalin at a similar rate was observed by Jacques and Harvey (1979, published literature). In
their study, oryzalin dissipated rapidly to day 50, but was continually found near the limit of
detection to day 350 with little change.
Parent oryzalin did not appear to be mobile. However, as no degradates were monitored
in the field and the laboratory mobility data is incomplete, it is not possible to define the
dissipation route of oryzalin. Oryzalin is not volatile, and. volatile by-products other than 14CO 2
were not significant in any submitted study.
Ring-labeled 14C-oryzalin has also been tested in the field (1975, Golab et. al., published
literature). After 36 months, 35% of the applied radioactivity was soil bound, 20% was
extractable (approximately 1% was parent oryzalin), and 45% "dissipated" from the upper 15
cm of the soil. Only a "small" amount of radioactivity was taken up by the crop. Bound residue
content appeared to remain stable between 2 months and 3 years. While this confirms that
irreversible soil binding is a significant field dissipation route for oryzalin, it may not be the only
significant route, as suggested by the submitted aerobic soil metabolism laboratory study.
For complete fulfillment of the terrestrial field dissipation data requirement, the registrant
must first provide an acceptable study of the mobility of oryzalin degradates. The registrant may
be required to re-analyze the field samples from this study, or to conduct a new study, if the
degradates prove to be mobile. Also, acceptable data on the wettable powder formulation at
two typical use field sites may be required. (MRID 41859701, 42138001; not acceptable at this
time)
165-4: Bioaccumulation in Fish:
Oryzalin does not accumulate significantly in fish. The concentration of oryzalin in tissues
reached a steady state at approximately 3 days after treatment. The study indicates that oryzalin
was not highly concentrated in bluegill sunfish: having a BCF of 32.2 in edible tissue, 105.7 in
nonedible tissue, 66.1 in whole fish. Within 24 hours depuration period there was 79.2%,
81.4% and 80.8% loss of radioactivity in edible, nonedible and whole fish respectively. By day
14 there was a loss of 88.7%, 95.1% and 93.6% in edible, nonedible and whole fish
respectively. Residues consisted primarily of oryzalin, two metabolites resulting from the
hydroxylation of theN-propyl group and a N-dealkylated metabolite.
(MRID 40787501, additional supporting information; acceptable)
201-1: Droplet Size Spectrum and 201-1: Field Drift Studies
Droplet size spectrum (201-1) and field drift studies (202-1) are needed to support ground
spray, aerial spray, and air-blast application methods for oryzalin. Spray drift studies are
required for aerially applied herbicides (e.g., air blast, etc.) with Tox. 1 or Tox. 2 classifications,
ot if the herbicide poses a potential environmental risk such as non-target phytotoxicity. The
registrant may elect to satisfy both data requirements through the Spray Drift Task Force,
29
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provided that the Agency does not require these data in advance of the Task Force's final report
(currently scheduled for December 1994).
b.
Environmental Fate Assessment
There are acceptable data on the mobility and dissipation route of parent oryzalin (3,5-
dinitro-N4,N4-dipropylsulfanilamide). However, there is no acceptable data on the mobility and
dissipation of the oryzalin degradates. The degradates have not been monitored in the field.
Submitted field studies monitored only the dissipation of parent oryzalin, which appears to
biodegrade slowly with a first half-life of approximately two months. Parent oryzalin does not
appear to be mobile under field conditions. While it appears that most of the applied oryzalin
either binds to soil or is fully mineralized, a maximum of 10-20% of oryzalin degradates may
leach. The identity and leaching rate of these compounds is not known. Without data on the
mobility and dissipation route of the oryzalin degradates, it is not clear whether leaching of
these degradates could represent a significant route of oryzalin dissipation in the field.
Published and submitted data indicate that parent oryzalin would be most mobile in coarse,
wet, alkaline soils with little organic matter. However, parent oryzalin would not be stable if it
were to leach to groundwater. Anaerobic conditions below the soil surface would cause the
chemical reduction of the compound. Oryzalin is not volatile.
Oryzalin can be applied aerially and by ground spray, and therefore could contaminate
surface waters by spray drift at application. Substantial quantities of oryzalin could also be
available for runoff for several days to months post-application depending in part upon the
degree of exposure to sunlight (photodegradation on soil half-life of 3.9 days; aerobic soil half-
life =2.1 months; terrestrial field dissipation half-lives of 77-146 and 58-138 days). The
moderately low to intermediate soil/water partitioning of oryzalin (K d = 2.1,4.9, 8.4, and 12.9;
KO,. from SCS database = 600) indicates that substantial fractions of oryzalin could be
transported via both dissolution in runoff water and adsorption to eroding soil.
The susceptibility of oryzalin to direct photolysis in water (half-life =1.4 hours) should
limit its persistence in clear shallow waters with low light attenuation. However, its resistance to
abiotic hydrolysis coupled with only a moderate susceptibility to aerobic and anaerobic
biodegradation indicate that it will be somewhat more persistent in receiving surface waters that
are deeper, have high light attenuation, low microbiological activities and long hydrological
resident times. Based upon its relatively low to intermediate soil/water partitioning, significant
fractions of the oryzalin in receiving surface waters should exist both dissolved in the water
column and adsorbed to suspended and bottom sediment. The reported BCFs for oryzalin (32X
to 106X) indicate that the bioaccumulation potential of oryzalin is relatively low.
The available data on the major degradates of oryzalin are insufficient to assess their
runoff characteristics or persistence in surface waters.
30
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No MCL or drinking water health advisories have been established for oryzalin. In
addition, oryzalin exhibits susceptibility to rapid direct photolysis in water and somewhat
intermediate soil/water partitioning which should contribute somewhat to its removal by the
primary treatment methods employed by most surface water source supply systems.
Consequently, the Agency is not currently recommending any monitoring of surface water
source drinking water supplies for oryzalin.
2. Ecological Effects
a. Ecological Effects Data
(1) Terrestrial Data
(a) Avian
The avian reproduction study conducted in 1982 did not have test doses for application
rates greater than 4 Ib a.i./A. Many non-crop and industrial uses at specialty sites were added
since the 1982 study was conducted and have application rates of 6 Ib a.i./A with a maximum
application of 12 Ib a.i./yr.
In order to determine whether these higher application rates pose a serious avian
reproduction threat, further avian reproduction tests must be conducted at higher doses
appropriate for single application rates greater than 4 Ib a.i./A and for multiple applications
greater than 1.5 Ib ai./A. The avian chronic assessment has great uncertainty. Data from avian
reproduction studies conducted at higher doses levels would reduce this uncertainty. Additional
data would confirm whether there are actual chronic avian effects at single application rates
greater than 4 Ib ai./A and multiple applications greater than 1.3 Ib ai./A.
Avian Acute and Dietary Tests. Avian Reproduction Test
The minimum data required to establish toxicity of oryzalin to birds are: 1) an avian acute
oral LD50 for one waterfowl species or upland game bird species and 2) a dietary LC 50 for one
waterfowl species and 3) a dietary LC 50 for one upland game bird. The preferred test species
are the mallard duck (waterfowl) and the bobwhite quail (upland game bird). Due to the
persistence of oryzalin, avian reproduction studies are required on both a waterfowl species and
an upland game bird species.
Avian Acute
An acute oral study on the bobwhite quail revealed an LD 50 of 506.7 nag/kg.
(MRID# 00098462)
31
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Avian Dietary
Dietary studies on the bobwhite quail and the mallard duck revealed LC sos > 5000
ppm (the highest concentration tested) for both species. (MRID# 00072593, 00072694)
In the dietary study conducted with the bobwhite quail, there was one mortality at
the 5000 ppm concentration but it was attributed to a mechanical injury and was not
considered a toxicant related death. Even though there was no mortality observed, the
bobwhite quail study did show reduced food consumption and body weight gain in all
concentrations tested including the lowest concentration of 625 ppm. In the dietary study
conducted with the mallard duck, there were no mortalities and no observable effects at
any of the concentrations tested.
Based on test results, oryzalin may be characterized as "slightly toxic" in acute
studies and "practically non-toxic" in dietary studies.
Avian Reproduction
Avian reproduction studies for the bobwhite quail and the mallard duck were
previously submitted in 1982. An avian reproduction study on the bobwhite quail was
submitted but did not fulfill guideline requirements due to control mortality. (MRID#
00129050)
An avian reproduction study on the mallard duck determined a NOEL of 1000
ppm, the highest level tested. This study was classified as core at the time the study
was first reviewed in 1982; however, it is now classified as supplemental because the
application rates for a single application have increased 4-fold from 1.5 Ibs a.i./A to
6.035 Ibs a.i./A. (MRID# 00126843; acceptable) Thus, the data requirements for
avian reproduction (71-4 (a) and (b)) have not been satisfied. Avian reproduction
studies on both species are needed to assess potential chronic effects due to the higher
application rates now in use as compared to 1982 and to assess the persistence of the
chemical.
However, for those doses tested in 1982, the NOEL determined is lower than
the calculated terrestrial EECs.
(b) Small Mammals
The minimum data required to establish toxicity to mammals is an oral acute
toxicity study. An oryzalin acute oral toxicity study had a LDSO> 10 g/kg. This
indicates oryzalin is practically nontoxic to small mammals on an acute oral basis.
32
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(2) Aquatic Data
(a) Effects on Freshwater Fish
The minimum data required to establish toxicity of oryzalin to
fish is a 96-hour acute toxicity test with 1) a coldwater and 2) a
warmwater species. The preferred species are the rainbow trout
(coldwater) and the bluegill sunfish (warmwater). In addition, fish early
lifestage studies were required due to the persistence of the chemical.
The 96-hour acute toxicity of oryzalin to the rainbow trout and
the bluegill sunfish were 3.26 ppm and 2.88 ppm, respectively. (MRID#
00072595) The MATC for fish early life-stage studies for the fathead
minnow and the rainbow trout were 0.22 ppm and 0.46 ppm,
respectively. (MRID#s 00126841, 00126842) Oryzalin is characterized
as "moderately toxic" to fish, based on the acute exposure.
(b) Effects on Freshwater Invertebrates
The minimum data requirement to establish acute toxicity to
freshwater invertebrates is a 48-hour acute study. The 48-hour LC50
value for oryzalin to Daphnia Magna was 1.4 ppm (MRID# 00072596).
Oryzalin is characterized as "moderately toxic" to aquatic invertebrates.
The Aquatic Invertebrate Life Cycle study (72-4(b)) is required
due to the persistence of oryzalin in the aquatic environment; acute
toxicity to Daphnids, and the solubility of oryzalin, which indicates that
it may be transported to aquatic habitat.
Based on existing information, the Agency anticipates that these
new data would refine concerns for chronic aquatic risks. However, we
do not anticipate that it will present one of the worst chronic risks
compared to other pesticides.
(c) Effects on Marine and Estuarine Organisms
No data on estuarine studies for oryzalin has been submitted to
the Agency for review. These data are necessary due to oryzalin's
persistence and likelihood of transport to estuarine environments. Tests
on marine and estuarine organisms are required for the following use
sites: berries, citrus fruits, cherry trees, pecans and golf course turf.
Although, oryzalin is moderately toxic to freshwater organisms, it
cannot be assumed that it will be moderately toxic to estuarine species.
33
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Toxicity tests are required on marine and estuarine species because it is
not known how the chemical will react in saline environments. In order
to establish the toxicity of oryzalin to estuarine and marine organisms,
the following tests are required using the technical grade material:
1) an Estuarine Fish 96-Hour Acute Toxicity Study, using the silver side
or sheepshead minnow and;
2) a Mollusk 48-Hour Embryo Larvae Study, using Pacific oyster,
Eastern oyster, mussel (preferably Mytilus edulis) or Quahog
(Mercenaria) and;
3) a Shrimp 96-Hour Acute Toxicity Study, using white, pink, brown,
grass or mysid shrimp.
Based on the moderate toxicity of oryzalin to freshwater fish and
invertebrates, the Agency predicts that when compared to other
pesticides, oryzalin is probably not one of the most toxic chemicals to
aquatic organisms. This assessment is based only on freshwater toxicity
data and does not take into account the exposure or the toxicity to
estuarine and marine organisms. The Agency is requiring the testing of
marine and estuarine species to confirm this assessment because results
from the freshwater tests cannot be extrapolated to estuari ne and marine
species.
(3) Non-Target Insects Data
The minimum data requirement to establish toxicity to non-target
insects is an acute contact honey bee study. The acute contact 48-hour
LDSO for honey bees is > 11 ug/bee (MRID# 00066220). Oryzalin is
classified as "practically nontoxic" to honey bees.
(4) Non-Target Plants Data
As expected for an herbicide, non-target terrestrial plants may be
"adversely affected from runoff and/or drift from the application of
oryzalin at the labeled rates on all of the use sites. Drift from aerial
application may adversely affect non-target plants.
Tier II testing is required for seed germination, seedling
emergence, and vegetative vigor using 10 terrestrial plant: species and
for aquatic plant growth using 5 aquatic plant species. Tier II studies
are laboratory/greenhouse studies using a minimum of five progressive
dosages and the end results should include a NOEL and an EC25 or EC50.
34
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The 10 species selected should represent a cross-section of the non-target
terrestrial plant population. Six dicots from at least four different
families and four monocots of at least two families are to be tested. ,
Based on all plant studies conducted with oryzalin on cabbage,
corn, cucumber, lettuce, oat, onion, radish, ryegrass, soybean and
tomato, the most sensitive monocot tested was ryegrass and the most
sensitive dicot tested was tomato. Germination studies measured two
parameters - percent germination and root length. The emergence and
vegetative vigor studies measured shoot length.
TEST TYPE
Germination
% Germination
Root Length
Emergence
Shoot Length
Vegetative Vigor
Shoot Length
MOST SENSITIVE
MONOCOT
EC^-O.Ollppmai
EC25=0.0024 ppm ai
EC^O.0285 ppm id
EC25=0.174 ppm ai
MOST SENSITIVE
DICOT
EC25=0.179 ppm ai
EC25=0.0797 ppm ai
EC25=0.0505 ppm ai
EC25=0.028 ppm ai
The EC2Ss for the germination test (MRID# 42602401), using root
length as the parameter, were: 0.020 Ib a.i./A for lettuce, the most sensitive
dicot tested; 0.001 Ib a.i./A for oat, the most sensitive monocot tested and
0.021 Ib a.i./A for onion, the most sensitive root crop tested. Additional
germination EC2Ss include: 0.078 Ib a.i./A for cabbage; 0.019 Ib a.i./A for
corn; 0.040 Ib a.i./A for cucumber; 0.0252 Ib a.i./A for radish; 0.011 Ib a.i./A
for ryegrass; 0.115 Ib a.i./A for soybean and 0.027 Ib a.i./A for tomato.
The EC25s for the emergence test (MRID# 42602401), using shoot
length as the parameter, were: 0.0285 ppm for ryegrass the most sensitive
monocot tested and 0.0505 ppm for tomato the most sensitive dicot tested and
0.318 ppm for onion the most sensitive root crop tested. Additional EC25s for
the emergence test include: 0.656 ppm for cabbage, 1.7 ppm for cucumber,
0.152 ppm for lettuce and 0.278 ppm for oats.
The EC^s for the vegetative vigor test (MRID# 42602401), using shoot
length as the parameter, were: 0.0828 Ib a.i./A for tomato the most sensitive
dicot tested and 0.174 Ib a.i./A for ryegrass the most sensitive monocot tested.
35
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Additional EC^s for the vegetative vigor test include: 0.244 Ib a.i./A for corn;
0.144 Ib a.i./A for lettuce and 0.445 Ib a.i./A for oats.
Aquatic Plants Data
The minimum data required to establish phytotoxicity is growth and
reproduction studies on five species from a cross-section of the non-target
aquatic plant population. The following aquatic plant species with their
corresponding EC50 values are presented below:
Anabaena flos-aquae
Lemna gibba
Navicula pelliculosa
Selenastrum capricornutum
Skeletonema costatum
EC50 = 24 ppm
EC50 =15.4 ppb
EC50 = 72 ppb
EC50 = 42 ppb
EC50 = 41 ppb
3. Ecological Risk Assessment
a. Terrestrial Organisms
The maximum expected terrestrial residues based on a single application at
different application rates and on different categories of plants is presented in Table 7.
These expected environmental concentrations (EECs) are from the Kenaga and Hoerger
(1972) monograph.
36
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Table 7. Estimated Residue of Oryzalin After A Single Application At Different
Application Rates on Different Categories of Plants
Application
Rate
(Ibs a.i./A)
0.751
l.O2
1.63
2.04
2.25
3.06
4.07
6.0358
Short
Grass
(ppm)
180
240
384
480
528
720
960
1448
Long
Grass
(ppm)
83
110
176
220
242
330
440
664
Leaves and
Leafy
Crops
(ppm)
94
125
200
250
275
375
500
754
Forage
(ppm)
44
58
93
116
128
174
232
350
Pods
Containing
Seeds (ppm)
9
12
19
24
26
36
48
72
Fruits
(ppm)
5
7
11
14
15
21
28
42
Ornamental Herbaceous Plants
Christmas Tree Plantings, Ornamental and/or Shade Trees, Ornamental Herbaceous Plants, Ornamental Woody Shrubs and Vines
Commercial/Industrial Lawns, Golf Course Turf, Ornamental Herbaceous Plants, Ornamental Lawns and Turf, Recreation Area
Lawns
Commercial/Industrial Lawns, Golf Course Turf, Ornamental and/or Shade Trees, Ornamental Herbaceous Plants, Ornamental
Lawns and Turf, Ornamental Woody Shrubs and Vines, Recreation Area Lawns
Commercial/Industrial Lawns, Golf Course Turf, Ornamental Lawns and Turf, Recreation Areas
Almond, Apple, Cherry, Golf Course Turf, Grapefruit, Grapes, Nectarine, Nonagricultural-Rights-of-Way, Olive, Orange,
Ornamental and/or Shade Trees, Ornamental Herbaceous Plants, Ornamental Lawns and Turf, Ornamental Woody Shrubs and
Vines, Peach, Pear, Pecan, Plum, Pomegranate, Power Stations, Recreation Area Lawns
Christmas Tree Plantings, Industrial Area (Outdoors), Nonagricultural Uncultivated Areas, Ornamental and/or Shade Trees,
Ornamental Herbaceous Plants, Ornamental Herbaceous Plants, Ornamental Lawns and Turf, Ornamental Woody Shrubs and
Vines
Almond, Apple, Apricot, Avocado, Blackberry, Blueberry Boysenberry, Cherry, Currant, Dewberry, Elderberry, Fig, Filbert
(Hazelnut), Gooseberry, Grapefruit, Grapes, Kiwi, Lemon, Loganberry, Macadamia Nut (Bushnut), Nectarine, Olive, Orange,
Peach, Pear, Pecan, Pistachio, Plum, Pomegranate, Prune, Raspberry (Black and Red), English Walnut
37
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Acute Risk to Avian Species
The acute risk to avian species from exposure to oryzalin was analyzed
by two methods - LD50 per square foot to characterize acute risk and LD50 per
day to characterize risk from daily dietary intake. The level of concern (LOG)
is exceeded when either index exceeds 0.5 LD^/ft2 or LD50 per day. As can be
seen from the above calculations, the LOG is exceeded, 0.698 LEVft2 > 0.5
LDso/ft2, for.LD50 per square foot index. However, the LDSO per day index is
the more appropriate one to use to characterize acute risk to avian species when
the innate toxicity of the chemical is less than highly toxic as is the case with
oryzalin, As this index has a value of only 0.26 LD50 per day, birds would
need to consume large amounts of the chemical in a single day to be at a high
risk to oryzalin, which is unlikely.
Subacute dietary risks to birds were also analyzed by comparing the
EEC's to the LC50 values. If the EEC is between 0.20 and 0.50 the dietary
LC50 value, the chemical is a candidate for restricted use classification.
The EEC for short grass based on a single application rate of 6.0 Ib
a.i./A (1449 ppm) may be greater than 0.20 LC50 (> 1,000 ppm) for the
bobwhite quail and mallard duck. The LC50s from the avian dietary studies
were shown to be in excess of 5,000 ppm, the maximum concentration tested.
The mallard duck study had no mortalities and the bobwhite quail study had 1
mortality at the 5,000 ppm level, which was not attributed to toxicity.
Because there was no mortality observed at the highest concentration
level tested, an LC50 was estimated to determine whether oryzalin was a
candidate for restricted use. If the LC50 were estimated as 5 times the proven
no mortality level, then .the estimated LC50 would be 25,000 ppm. One-fifth of
the estimated LC50 would be 5,000 ppm and 0.50 would be 12,500 ppm. Both
values are greater than the EEC (1,449 ppm) for a single application at 6 Ib
a.i./A. Therefore, oryzalin does not pose an acute risk to avian species since
the restricted use classification (0.20 LC50) level of concern was not exceeded.
From the data analyzed, there are minimal risks to avian species from
acute and dietary exposure to oryzalin.
To calculate mg a.i./ft2:
6.035 Ib a.i. x 454,590 mg x 1 Acre = 62.98 mg a.i./ft2
A Ib 43,560 ft2
The LD50 for the bobwhite quail is 506.7 mg/kg. According to Duning (1984),
the average weight of a bobwhite quail is 0.178 kg.
38
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To calculate LD50s per square foot
62.98 mg/ft2
506.71 mg/kg x (0.178 kg1) = 0.698
To calculate LD50 per day:
(highest expected residue) x (Percentage eaten per day)
LD50
Using the highest expected residues for the highest application rate (see
Table 7) and the LD50 for the bobwhite quail the following LD50 per day is
calculated:
1448 ppm x 9.2%
506.7 mg/kg
0.263 LD50 per day
Chronic Risk to Avian Species
The avian reproduction study conducted in 1982 did not have test doses
for application rates greater than 4 Ib a.i./A. These studies showed no
observable adverse effects (NOEL) at 1000 ppm, the highest rate tested.
However, the use of oryzalin at single applications greater than 4 Ib a.i./A and
multiple applications greater than 1.5 Ib a.i./A may present a potential for
chronic risk to birds because a lowest observable effect level (LOEL) has not
been determined and the EEC's are higher than the actual doses tested.
Oryzalin has biphasic kinetics. In addition to the Kenaga approximation
method used to calculate the terrestrial EECs, a second method, the "Fate
Program" was also used to calculate EECs for multiple applications of oryzalin.
The initial residue value for the "Fate Program" was based on the maximum
residue amount on short grass from a single application. The "Fate Program"
utilizes additional information about the chemical properties of oryzalin such as
half-life. Oryzalin has a first phase half-life of 60 days and a second phase half-
life of 120 days and it is reasonable to assume that the third phase is
considerably longer. Residue values using the Fate Program were calculated
using a one-phase half-life of 120 days. Oryzalin can be applied at 6.035 Ib
a.i./A twice a year with a 90-day interval period, at 4 Ib a.i./A three times a
year with a 60-day interval period, and 2 Ib a.i./A four times a year with a 60-
day interval period.
Using the "Fate Program" and the expected maximum application rate (6.035
Ibs ai/A twice a year with a 90-day interval period) for one year, oryzalin could
have an EEC of 2310 ppm. Based on the Kenaga approximation method (see
39
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Table 6), the EEC for oryzalin used at the 6.035 Ib a.i./A rate twice a year
with a 90-day interval period for one year, would be 2896 ppm. These residues
would be for the first year of use and do not take into account the residues that
would build up over years of use.
Based on the Kenaga approximation method (see Table 7), the EEC for
the 2 Ib rate used four times a year would be 1920 ppm for short grass. Using
the Fate Program, the EEC for the 2 Ib rate used four times a year would be
1229 ppm for short grass. Both the Kenaga approximation method and the Fate
Model indicate that the EEC will be greater than the NOEL of 1000 ppm.
Oryzalin does not appear to pose a chronic risk to birds at single
application rates of 4 Ib a.i./A or less because the risk quotients for the different
categories of plants are less than 1, the Level of Concern (LOG). However, the
risk quotient for single applications at the 6 Ib a.i./A is 1.5 for birds feeding on
short grass. Multiple applications of the 1.5 Ib a.i./A rate on turf (3
applications) and the 2.0 Ib ai./A rate on a variety of uses (4 applications) will
provide risk quotients of 1.2 and 2.0 for birds feeding on short grass,
respectively. Risk quotients greater than 1 are in exceedance of the avian
chronic LOG. These values indicate the potential for chronic risk to birds. The
potential is increased because oryzalin is a moderately persistent compound.
The avian chronic assessment has great uncertainty due to the fact that a
lowest observable effect level (LOEL) has not been determined and that the
EEC's are higher than the actual doses tested. Data from avian reproduction
studies conducted at higher doses levels would reduce this uncertainty.
Additional data would confirm whether there are actual chronic avian effects at
single application rates greater than 4 Ib ai./A and multiple applications greater
than 1.51bai./A.
Risk to Small Mammals
This small mammals risk assessment is based on a sole toxicity test using
laboratory rats. The test resulted in a rat LD50 > 10 g/kg which indicates that
oryzalin is practically nontoxic to small mammals. Due to this lack of toxicity,
oryzalin is not expected to present a risk to small mammals exposed under field
conditions.
b. Aquatic Organisms
Estimated aquatic environmental concentrations (EECs) were calculated
using the methods of Kenaga and Hoerger (1972) and are presented in Table 8.
40
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Acute and Chronic Risk
A single inadvertent direct application to water at the maximum rate of
6,035 Ib a.i./A would yield estimated environmental concentrations (EECs) of
4.43 ppm in shallow (6-inch) water and 0.368 ppm in deep (6-foot) water. The
shallow water EEC exceeds the acute LOG LC50 values for all aquatic species
tested (Daphnia magna, LCSO =1.5 ppm; rainbow trout, LC50 = 3.3 ppm; and
bluegill sunfish, LC50 = 2.9 ppm) in addition to the chronic MATC values for
the fathead minnow (0.2 ppm). Multiple applications9 of oryzalin may also
pose a chronic risk to aquatic organisms.
Using a 10-acre field draining into a 1-acre pond with 1 % runoff and
5% drift for aerial applications (including mist blowers), the 6-inch EEC is
0.487 ppm and the 6-foot EEC is 0.04 ppm. The EECs for unincorporated
ground application (a 10-acre field draining into a 1-acre pond with 1% runoff)
is 0.0368 ppm at 6-feet and 0.443 ppm at 6-inches. All EECs are based on a
single application rate of 6.035 Ib a.i./A.
Oryzalin does not appear to pose a risk to nonendangered freshwater
species as all EEC's from ground and aerial application for oryzalin are below
the level of concern (LOG = 0.50 LC50 value). The 6-foot EECs are lower than
the 0.50 LC50 values of Daphnia magna (0.75 ppm), rainbow trout (1.65 ppm),
and bluegill sunfish (1.45 ppm).
Based on'existing information, the Agency anticipates that these new
data would refine concerns for chronic aquatic risks. However, we do not
anticipate that it will present one of the worst chronic risks compared to other
pesticides. Therefore, a chronic aquatic invertebrate study is required to
confirm this assessment because a potential chronic risk to aquatic invertebrates
is possible.
The Agency requires data for guidelines 72-3a,b, and c for effects on
marine and estuarine organisms. No data on estuarine studies for oryzalin have
been submitted to the Agency for review.
Based on the moderate toxicity of oryzalin to freshwater fish and
invertebrates, the Agency predicts that when compared to other pesticides,
oryzalin is probably not one of the most toxic chemicals to aquatic organisms.
This assessment is based only on freshwater toxicity data and does not take into
account the exposure or toxicity to estuarine and marine organisms. The
Agency is requiring the testing of estuarine species to confirm this assessment
Oryzalin has biphasic kinetics. See footnote 11.
41
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because results from the freshwater tests cannot be extrapolated to estuarine and
marine species.
Table 8. Estimated Aquatic Environmental Concentrations (EECs) Immediately after Application
Application Rate
(Ib a.i./A)
0.75"
l.O14
1.615
2.016
2.2"
3.018
4.0"
6.03520
EEC - Ground
Application (ppb)10
4.6
6.1
9.8
12.2
13.4
18.3
24.4
36.8
EEC - Aerial
Application (ppb)11
5.03
6.71
10.74
13.42
14.76
20.13
26.84
40.49
EEC - Direct
Application (ppb)12
45.8
61
97.6
122
134.2
183
244
368.1
10
11
12
13
14
15
16
17
18
19
20
The total aquatic EEC from a 10-acre field treated by unincorporated ground application and draining into a 6-foot
deep 1-acre pond.
The total loading from both runoff (1%) and drift (5%) of a 10-acre field treated by aerial application and draining into
a 6-foot deep, 1-acre pond. Aerial application includes mist blowers.
A single inadvertent direct application to a 6-foot deep, 1-acre pond.
Ornamental Herbaceous Plants
Christmas Tree Plantings, Ornamental and/or Shade Trees, Ornamental Herbaceous Plants, Ornamental Woody Shrubs
and Vines
Commercial/Industrial Lawns, Golf Course Turf, Ornamental Herbaceous Plants, Ornamental Lawns and Turf,
Recreation Area Lawns
Commercial/Industrial Lawns, Golf Course Turf, Ornamental and/or Shade Trees, Ornamental Herbaceous Plants,
Ornamental Lawns and Turf, Ornamental Woody Shrubs and Vines, Recreation Area Lawns
Commercial/Industrial Lawns, Golf Course Turf, Ornamental Lawns and Turf, Recreation Areas
Almond, Apple, Cherry, Golf Course Turf, Grapefruit, Grapes, Nectarine, Nonagricultural-Rights-of-Way, Olive,
Orange, Ornamental and/or Shade Trees, Ornamental Herbaceous Plants, Ornamental Lawns and Turf, Ornamental
Woody Shrubs and Vines, Peach, Pear, Pecan, Plum, Pomegranate, Power Stations, Recreation Area Lawns
Christmas Tree Plantings, Industrial Area (Outdoors), Nonagricultural Uncultivated Areas, Ornamental and/or Shade
Trees, Ornamental Herbaceous Plants, Ornamental Herbaceous Plants, Ornamental Lawns and Turf, Ornamental
Woody Shrubs and Vines
Almond, Apple, Apricot, Avocado, Blackberry, Blueberry Boysenberry, Cherry, Currant, Dewberry, Elderberry, Fig,
Filbert (Hazelnut), Gooseberry, Grapefruit, Grapes, Kiwi, Lemon, Loganberry, Macadamia Nut (Bushnut), Nectarine,
Olive, Orange, Peach, Pear, Pecan, Pistachio, Plum, Pomegranate, Prune, Raspberry (Black and Red), English Walnut
42
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Aquatic - Endangered Species
The level of concern is exceeded when the EEC exceeds 0.05 of the LC50 value. The
6-foot EECs are lower than the 0.05 LC50 (= LOG) value of the Daphnia magna (0.05 LC50
= 0.075 ppm), the most sensitive species tested. Therefore, oryzalin does not appear to
pose an aquatic risk to either endangered or threatened species in deep water (6 ft) adjacent
to treated fields at the current application rates.
However, in shallow water (6 in) adjacent to treated fields, the EECs exceed 0.05 LC50
values for all aquatic species tested (Daphnia magna, 0.075 ppm; rainbow trout, 0.165 ppm;
bluegill sunfish, 0.145 ppm) and the MATC value for the fathead minnow, 0.2 ppm. In
shallow water regions, application rates greater than or equal to 1.0 Ib a.i./A may adversely
impact endangered invertebrate species that inhabit these regions. Likewise, single
application rates greater than or equal to 2.0 Ib a.i./A may adversely impact endangered fish
species that inhabit these regions. Therefore, oryzalin poses a potential risk to endangered
aquatic species that occur in shallow regions of water.
c. Non-Target Plants
(1) Terrestrial Plant Risk
Terrestrial EEC due to Runoff from Unincorporated Ground Application
The runoff scenario for terrestrial nontarget plants from a terrestrial application
assumes 1% runoff from 1 acre onto an adjacent acre.
UNINCORPORATED GROUND APPLICATION
Runoff
6.04 Ib a.i./A x 1% runoff x 1 A = 0.0604 Ib a.i./A
Terrestrial EEC due to aerial application
Runoff
6.035 Ib a.i./A x 60% app. effc. x 1% runoff x 1 A = 0.03621 Ib a.i./A
Drift
6.035 Ib a.i./A x 5% drift = 0.302 Ib a.i./A
Total
0.03621 (runoff) + 0.302 (drift) = 0.33821 Ib a.i./A
Germination
The germination EC^s for three sensitive crops are equal to or exceeded by the
EECs produced by a range of application rates for ground spraying. The germination
EC25s, based on root length, are: lettuce, the most sensitive dicot tested (0.1791 Ib
a.i./A); oat, the most sensitive monocot tested (0.0072 Ib a.i./A) and onion, the most
43
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sensitive root crop tested (0.18 Ib a.i./A). Ground applications of oryzalin as low as
0.75 Ibs ai/A exceed the germination EC25 for oat, a representative of monocots. Since
oryzalin applications may occur as high as 6.035 Ib a.i./A, there is an apparent high
risk to nontarget plants posed by runoff due to the unincorporated ground application
of oryzalin.
The minimum aerial application rates (with their corresponding EECs in Ib
a.i./A) likely to affect various crops according to seed germination EC25s are shown in
Table 9.
Table 9.
Application Rates EECs Which Exceed Seed Germination
(based on root length) ECW Values
Application Rate
(Ib a.i./A)
1.0
4.0
4.0
EECdb)
0.05
0.2
0.2
Crop of Concern
oat (monocot)
lettuce (dicot)
onion (root)
EC2S(1!>)
0.0072
0.1791
0.18
This table indicates that aerial applications (soil route of .exposure) of oryzalin
ranging from these minimum rates up to the maximum current label rate of 6.035 Ib
a.i./A may pose a risk to nontarget plants. Aerial applications as low as 1.0 Ib a.i./A
can affect oat, a representative of monocots and aerial applications of 4 Ib a.i./A and
above can affect lettuce and onion, representatives of a dicot and root crop,
respectively.
Emergence
The EEC for terrestrial plants is 0.34 ppm from both runoff and drift. The
emergence EC^ based on ryegrass shoot length is 0.03 ppm. The risk quotient is 11.3
(0.34/0.03). The Risk Quotient (RQ) Level of Concern (LOG) for plants including
threatened and endangered plants is 1. Since 11.3 is greater than 1, the level of
concern is exceeded. Risk to terrestrial plants including federally listed threatened and
endangered terrestrial plants is expected. Eliminating aerial application would decrease
but not eliminate this risk.
Vegetative Vigor
The vegetative vigor EC25S for several crops are equal to or exceeded by the
EECs produced by a range of application rates for aerial spraying. The vegetative
vigor EC^s, based on shoot length, are: corn (0.244 Ib a.i./A), lettuce (0.144 Ib
a.i./A), oat (0.445 Ib a.i./A), ryegrass (0.174 Ib a.i./A) and tomato (0.0828 Ib a.i./A).
The total terrestrial EEC from aerial application (including mist blowers and sprinkler
: 44
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irrigations) of 6.035 Ib a.i./A was 0.338 Ib a.i./A (see calculations above). The total
terrestrial EEC from aerial application (0.338 Ib) exceeds the vegetative vigor EC25s
for corn, lettuce, ryegrass and tomato. Therefore, these studies suggest that aerial
application of oryzalin may pose a risk to these crops via the foliar route of exposure.
The minimum aerial application rates (with their corresponding EECs in Ib
a.i./A) likely to affect various crops according to vegetative vigor EC^s are shown
below in Table 10.
Table 10.
Application Rates EECs Which Exceed Seed Germination
(based on root length) EC25 Values
Application Rate
(Ib a.i./A)
1.6
3.0
4.0
6.0
EECdb)
0.08
0.15
0.2
0.3
Crop of Concern
tomato (dicot)
lettuce (dicot)
ryegrass (monocot)
corn (monocot)
EC2S(lb)
0.0828
0.144
0.174
0.244
This table indicates that aerial applications of oryzalin ranging from these
minimum rates up to the maximum current label rate of 6.035 Ib a.i./A may pose a
risk to nontarget plants. Aerial applications as low as 1.6 Ib a.i./A can affect tomato
plants, a representative of dicots and aerial applications at 4 Ib a.i./A and above can
affect ryegrass, a representative of monocots.
(2) Aquatic Plant Risk
The EEC for 6.035 Ib ai applied to a 10-acre field draining into a 1-acre 6-foot
deep water body is 37 ppb. The most sensitive aquatic EC50 =15.4 ug/L (Lemna
gibba). The risk quotient is 2.4 (37 ppb/15.4 ppb). The LOG for plants, including
threatened and endangered plants is 1. Since 2.4 is greater than 1, the LOG is
exceeded. Risk to aquatic plants including federally listed threatened and endangered
aquatic plants is expected.
d. Endangered and Threatened Species
Federally listed endangered and threatened aquatic organisms may be at
risk in shallow water adjacent to treated areas. In addition, oryzalin may
adversely affect federally listed endangered and threatened plants.
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The Endangered Species Protection Program is expected to become final
in early 1995. Limitations on the use of oryzalin will be required to protect
endangered and threatened species, but these limitations have not yet been
defined (and may be formulation specific). OPP anticipates that consultation
with the Fish and Wildlife Service will be conducted in accordance with the
species-based priority approach described in the Program. After completion of
consultation, registrants will be informed if any required label modifications are
necessary. Such modifications would most likely consist of the generic label
statement referring pesticide users to use limitations contained in county
Bulletins.
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 oryzalin as an active ingredient. However,
upon review of the existing database, the Agency has determined that it does not have
sufficient data at this time to make a reregistration decision for use on residential lawns and
turf. Appendix B identifies the generic data requirements that the Agency reviewed as part
of its determination of reregistration eligibility of oryzalin, 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 oryzalin and to determine that oryzalin can be used without resulting in
unreasonable adverse effects to humans except for residential lawn and turf uses for which
insufficient data were available to assess exposure/risk to persons reentering treated lawns
and turf. Further, oryzalin poses a potential risk to nontarget plants from runoff due to
unincorporated ground and aerial application. To address these concerns, the registrant has
agreed to limit aerial application to crop uses in California. Also, in order to be effective,
oryzalin products need to be watered-in, a practice that should help reduce runoff. The
registrant has also agreed to specify the maximum seasonal application rates and the intervals
between applications. The Agency is incorporating these changes in this Reregistration
Eligibility Decision. Oryzalin may also pose a risk to endangered aquatic and terrestrial
plants, however, the Agency will be addressing these concerns through the Endangered
Species Protection Program which is currently being developed and is discussed in item B.4.
in this section. The Agency, therefore, finds that all products containing o^zalin, except
for those products registered for use on residential lawns and turf, 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
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that most uses of oryzalin are eligible for 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 oryzalin, 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
The Agency has determined that products containing oryzalin are eligible for
reregistration except for products labelled for use on residential lawns and turf.
Eligible oryzalin products, labelled and used as specified in this Reregistration Eligibility
Decision document, will not pose unreasonable adverse effects to humans or the
environment. The Agency does not have enough information at this time to make an
eligibility determination for products labelled for use on residential lawns and turf. In order
to develop an adequate database to support this use, the Agency is requiring that additional
data be submitted. Those oryzalin products which contain other active ingredients will be
eligible for reregistration only when the other active ingredients are determined to be eligible
for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that products labelled for the following uses of oryzalin
are eligible for reregistration: Orchard, berries, and vine crops, Christmas tree plantations,
field-grown roses, nursery stock, ornamentals, golf courses, non-crop areas, and parks and
greenhouse drainage areas. No uses were found ineligible for reregistration. Residential
lawn and turf uses had insufficient data available to make a reregistration eligibility decision.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for oryzalin.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document. Except for those uses where there is an insufficient database, the Agency has
determined that all uses are eligible for reregistration.
1. Tolerance Reassessment
Tolerances listed under 40 CFR §180.304(a):
Tolerances for residues of oryzalin in/on plant commodities listed under 40
CFR §180.304(a) are expressed in terms of the combined residues of oryzalin per se.
No tolerances have been established for animal commodities.
The tolerance expression for 40 CFR §180.304(a), which incorrectly states that
"Tolerances are established for the combined residues of the herbicide oryzalin
(3,5-dinitro-N4,N4-dipropylsuIfanilaniide) in or on the following raw agricultural
commodities:", will be modified to remove the words "the combined."
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Sufficient data are available to ascertain the adequacy of the established
tolerances listed in 40 CFR §180.304(a) for: almonds; almond hulls; avocados; citrus
fruits; figs; kiwifruits; olives; pistachios; pome fruits; pomegranates; small fruits;
stone fruits; and tree nuts; see Table 11 for modifications in commodity definitions.
Sufficient data are available to determine that residues of oryzalin do not
concentrate in any apple, grape, or plum processed food/feed item; thus, food/feed
additive tolerances are not required for these commodities. Additional processing
studies for citrus and olives have been required and currently in progress. These data
are considered confirmatory to the existing evidence that residues of oryzalin do not
concentrate upon processing. However, if residues are found to concentrate in citrus
or olive processed commodities, the Agency, under current policy, would not be able
to establish food or feed additive regulations because such regulations would be
inconsistent with the Delaney Clause of Section 409 of the Federal Food, Drug and
Cosmetic Act. Future policy decisions may impact Section 408 tolerances (raw
agricultural commodities) for any oryzalin treated crop where concentration occurs in
the processed commodity.
The Agency has proposed (58 FR 44990, August 25, 1993) revisions to the
crop group classifications currently listed in 40 CFR §180.34(f). There are no
proposed changes to the citrus fruits group, pome fruits group, stone fruits group, and
tree nuts group. However, the crop group "small fruits and berries" will be changed to
the crop group "berries" with the removal of grapes and strawberries, which will be
classified as miscellaneous commodities. At such time as this proposed rule is
finalized, the current oryzalin tolerance for "small fruits" should be revised to
"berries" and a separate tolerance of 0.05 ppm for grapes should be established.
Tolerances currently exist for residues of oryzalin in/on cottonseed, barley
grain, wheat grain, peas (succulent), potatoes, and soybeans. As there are currently no
registered uses of oryzalin on these crops, these tolerances will be proposed for
revocation.
The tolerances for oryzalin residues in/on peppermint hay, spearmint hay,
sweet potatoes, peppermint oil, and spearmint oil have been revoked (56 FR 26915,
June 12, 1991).
Tolerances listed under 40 CFR §180.304(b):
Tolerances for residues of oryzalin with regional registration listed under 40
CFR §180.304(b) are expressed in terms of the combined residues of oryzalin per se
(57 FR 59823, December 16, 1992).
Sufficient data are available to ascertain the adequacy of the established
tolerances listed in 40 CFR §180.304(b) for guavas and papayas.
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A tolerance of 0.05 ppm has been proposed (PP#8E3686) for residues of
oryzalin in/on green coffee beans.
Table 11. Tolerance reassessment summary for oryzalin.
Commodity
Almond, hulls
Avocados
Citrus fruits
Cottonseed
Figs
Grain, barley
Grain, wheat
Kiwifruits
Nuts
Olives
Peas (succulent)
Pistachios
Pome fruits
Pomegranates
Potatoes
Small fruits
Soybeans
Stone fruits
Current Tolerance
(ppm)
Tolerance
Reassessment
Comment/ Correct
Commodity Definition
Tolerances listed under 40 CFR §180.304(a):
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.10
0.05
0.05
0.05
0.05
Revoke
0.05
Revoke
Revoke
0.05
0.05
0.05
Revoke
0.05
0.05
0.05
Revoke
0.05
Revoke
0.05
Almonds, hulls
No registered uses exist.
No registered uses exist.
No registered uses exist.
Tree nuts
No registered uses exist.
No registered uses exist.
Berries; and
GrapesI Proposed crop
group revision.
No registered uses exist.
Tolerances listed under 40 CFR §180.304(b):
Beans, green coffee
Guavas
Papayas
N/A
0.05
0.05
N/A
0.05
0.05
0.05 ppm tolerance
proposed.
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2. Restricted Use Classification
Oryzalin is not currently classified for restricted use. The Agency has
determined that oryzalin products should not be classified for restricted use at
this time. After an analysis of additional data submitted, the Agency will
reassess whether any oryzalin uses warrant a restricted use classification.
3.
Reference Dose/Cancer Risk
The reference dose for oryzalin was determined to be 0.12 mg/kg/day, based on
the chronic feeding study with rats in which the NOEL was 12.16 mg/kg/day and an
uncertainty factor of 100. The cancer potency factor for oryzalin is 1.3 x 10"1
(mg/kg/day)"1.
a) Dietary Risk
The chronic dietary exposure based on anticipated residue contribution (ARC)
estimates are very low—less than 1/5,000th of the RfD for each of the groups and
subgroups that the DRES analyses. Based on the same data, the dietary excess cancer
risk estimate for the U.S. population is 8.1 x 10"7. The upper bound risk is expected to
be even lower (4.5 E-7) when tolerances are revoked for unregistered commodities.
b) Worker Risk
The cancer risks to mixers, loaders and applicators, assuming the following
minimum personal protective equipment (PPE): coveralls over long-sleeved shirt and
long pants, and chemical-resistant gloves, were all less than 10"4, or have margins of
exposures (MOEs) greater than 100, except for low-pressure handwand application.
Exposures for low-pressure handwand application will be adequately reduced (MOE
greater than 100) with the imposition of chemical-resistant footwear. Other PPE and
reentry intervals are addressed in Section V.
4. Endangered Species Statement
The Agency has concerns about the exposure of threatened and endangered
aquatic species in shallow waters to oryzalin as discussed in the science assessment
section. Currently, the Agency is developing a program (The Endangered Species
Protection Program") to identify all pesticides whose use may cause potential adverse
impacts on endangered and threatened species and to implement mitigation measures
that will eliminate the adverse impacts. The program will require use modifications or
a generic product label statement, requiring users to consult county-specific bulletins.
These bulletins will provide information about specific use restrictions to protect
endangered and threatened species in the county. Consultations with the Fish and
Wildlife Service will be necessary to assess risks to newly listed species or from
proposed new uses.
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The Agency plans to publish a description of the Endangered Species Protection
Program in the Federal Register and have enforceable county-specific bulletins
available by 1995. Because the Agency is taking this approach for protection
endangered and threatened species, it is not imposing label modifications at this time
through the RED document. Rather, any requirement for product use modifications
will occur in the future under the Endangered Species Protection Program.
5. Worker Protection Requirements
a. Compliance with Worker Protection Standard
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 Worker Protection Standard for Agricultural Pesticides (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
supple men tally 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.
(1) Mixer/Loader/Applicator Personal Protective Equipment
(PPE) Requirements for Oryzalm
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 about the acute or 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.
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2. If the Agency 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:
• In the RED for that active ingredient, EPA may establish minimum or
"baseline" handler PPE requirements 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.
• 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 special lexicological concerns about oryzalin (classified as a Group C
carcinogen) that warrant the establishment of active-ingredient-based minimum PPE
requirements. These requirements, which are discussed below, are also based on the
Agency's exposure assessment.
Handler PPE for Occupational-Use Products
• WPS Uses: End-use products with uses of oryzalin that are within the
scope of the Worker Protection Standard (WPS) must have the following minimum
(baseline) PPE: coveralls over long-sleeved shirt and long pants, chemical-resistant
gloves, chemical-resistant footwear, and chemical-resistant headgear for overhead
exposures for all handlers. Mixers and loaders must also wear a chemical-resistant
apron.
• Non-WPS Uses: End-use products with occupational uses of oryzalin
outside the scope of the Worker Protection Standard must have the following minimum
(baseline) PPE: coveralls over long-sleeved shirt and long pants, chemical-resistant
gloves, chemical-resistant footwear, and chemical-resistant headgear for overhead
exposures for all handlers. Mixers and loaders must also wear a chemical-resistant
apron.
Handler PPE for Homeowner-Use Products
For oryzalin products with homeowner uses, the following PPE are required:
Long-sleeved shirt, long pants, and chemical resistant gloves.
(2) Early Entry Personal Protective Equipment (PPE) for
Oryzalin
The WPS establishes very specific restrictions on entry by workers to areas that
remain under a restricted-entry interval if the entry involves contact with treated
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surfaces. Among those restrictions are a prohibition of routine entry to perform hand
labor tasks and a requirement that personal protective equipment be worn. Personal
protective equipment requirements for persons who enter areas that remain under a
restricted-entry interval and who contact treated surfaces are based on the toxicity
concerns about the active ingredient. The requirements are set in one of two ways.
1. If the Agency 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 the Agency 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.
Early Entry PPE for Occupational Use Products
• WPS Uses; Since oryzalin is categorized as a Group C
carcinogen and the Agency's exposure assessment for handlers warrants it, the
PPE required for early entry is coveralls over long-sleeved shirt and long pants,
chemical-resistant gloves, chemical-resistant footwear plus socks, and chemical-
resistant headgear for overhead exposures.
• Non-WPS Uses: Some of the registered uses of oryzalin are
outside the scope of the Worker Protection Standard. The Agency is not
requiring early entry PPE for these uses (e.g. rights-of-way, golf courses)
because significant exposure is unlikely. Exposure is limited primarily to
walking on treated surfaces rather than full contact with foliage.
(3) Post-application Entry Restrictions for Oryzalin
Entry Restrictions for Occupational-Use Products
Under the Worker Protection Standard (WPS), interim restricted entry
intervals (REI) for all uses within the scope of the WPS are established 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 n, 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
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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:
product-specific REI's established on the basis of adequate data and interim
REI's that are longer than those that would be established under the WPS.
• WPS Uses: For those end-use products with registered
uses of oryzalin within the scope of the Worker Protection Standard, the
following Restricted Entry Interval (REI) is required. The Agency is
establishing a 24-hour interim restricted-entry interval pertaining to each use of
the product that is within the scope of the Worker Protection Standard. This
requirement is based on oryzalin being classified as a Group C carcinogen. The
REI remains interim, since data on post-application exposures are being
required. The Agency will establish a permanent REI once the required post-
application exposure data are generated by the registrant and reviewed by the
Agency. These data are specified in Part V.
The Agency notes that the labeling directions for some uses of oryzalin
require the application to be watered-in to a specified level, such as 1/2 to 1
inch of rainfall or irrigation. If oryzalin has been correctly incorporated
through watering-in at the label-specified rate, workers may enter the treated
area during the restricted-entry interval without personal protective equipment
or any other restriction if they are performing tasks that do not involve contact
with the soil subsurface.
The WPS REI in effect until now was 12 hours. The Agency found no
extenuating circumstance for retaining the 12-hour interim REI placed on
oryzalin products by PR Notice 93-7. The Agency notes that the 12-hour
interim WPS REI was established based on acute toxicity concerns only and did
not take into account oryzalin's classification as a Group C carcinogen.
• Non-WPS Uses: The Agency is requiring that the entry for non-
WPS occupational uses of oryzalin be the following. See section V of this
document for specific label language.
• for liquid applications: a prohibition on entry until the sprays have
dried;
• for dry applications: a prohibition on entry until dusts have settled.
• for all other non-WPS applications: a prohibition on entry until sprays
have dried or dusts have settled.
• Residential Uses: The Agency is requiring that the entry restriction for
residential uses of oryzalin be the following:
• for all applications: a prohibition on entry for people or pets until
sprays have dried or dusts have settled.
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Reentry Data Requirements
Since oryzalin is a possible human carcinogen and is persistent, the
Agency is concerned about chronic post-application exposures to homeowners,
including children, resulting from applications made to residential lawns. At
this time, the Agency does not have sufficient information to estimate post-
application exposure for uses of oryzalin on residential lawns and turfgrass and
is, therefore, unable to conduct an exposure assessment for this use. For the
residential lawn and turfgrass use to be eligible for reregistration, the following
data are required: foliar dislodgeable residues (guideline 132-la), soil
dislodgeable residues (guideline 132-lb), estimation of dermal exposure
(guideline 133-3), and estimation of inhalation exposure (133-4).
6. Other WPS-Related Labeling
User safety statements are required for all oryzalin products and are listed in
Section V. In some cases, handler PPE requirements may be reduced or
modified when engineering controls are used. This is also described in Section
V.
7. Grazing Restrictions
All end-use product labels must be amended to include a restriction against
grazing or feeding crops grown in treated areas to livestock.
8. Changes in Directions for Use
In order to minimize oryzalin exposure, the Agency is requiring that all end-use
products specify application rates, number of applications per year, total pounds
of a.i. per year, and intervals between application. These requirements are
detailed in part V under End-Use Labeling.
9. Precautionary Statement for Fish
In order to provide protection for fish that may be exposed to oryzalin, a fish
toxicity statement is required. See Part V under end-use labeling.
10. Spray Drift Advisory
The registrant has agreed to restrict aerial application of oryzalin products to
agricultural uses in California only. 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 oryzalin products that may be applied aerially
to agricultural crops.
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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 oryzalin for the above
eligible uses has been reviewed and determined to be substantially complete for all uses
except residential lawns and turf. However, additional confirmatory data are needed to
fulfill requirements for the studies listed below:
Avian Reproduction - mallard and quail (for single applications greater than 4 Ib a.i./A
and multiple applications greater than 1.5 Ib a.i./A)
Acute Toxicity to Estuarine and Marine Organisms - fish, mollusk, shrimp
Aquatic Invertebrate Lifecycle
Dermal Irritation
Leaching/Adsorption/Desorption (current testing is underway to determine oryzalin
degradate mobility)
Spray Drift
Storage Stability (apples and grapes - studies underway)
Processing Studies (citrus and olives - studies underway)
Mixer/Loader/Applicator Exposure Monitoring
Estimation of Dermal Exposure at Outdoor Sites (for low pressure handwand
application)
Estimation of Inhalation Exposure at Outdoor Sites (for low pressure handwand
application)
Reentry Protection
Foliar Dislodgeable Residues (Christmas trees, field-grown roses)
Estimation of Dermal Exposure (Christmas trees, field-grown roses)
Estimation of Inhalation Exposure (Christmas trees, field-grown roses)
The following data are required to support the use of oryzalin on residential
lawns and turfgrass: '•
Foliar Dislodgeable Residues
Soil Dislodgeable Residues
Estimation of Dermal Exposure
Estimation of Inhalation Exposure
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2. Labeling Requirements for Manufacturing-Use Products
The Agency has determined that the current label precautions are still applicable
and are required for product reregistration if the product is to remain in compliance
with FIFRA (see 1987 Oryzalin Registration Standard).
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
a. Worker Protection Standard
(1) Post-Application Reentry Restrictions; Labeling
• WPS Uses: In order to remain in compliance with FIFRA, a 24
hour REI is required for all oryzalin end-use products registered for uses
that are within the scope of WPS.
The 24 hour REI should be inserted into the standardized REI
statement required by PR Notice 93-7.
• Non-WPS Uses: The following entry prohibition for
non-WPS occupational use products of oryzalin is required:
For Liquids: "Keep all persons, children and pets out of the treated
area until sprays have dried."
For Dry Formulations: "Keep all persons, children and pets out of the
treated area until dusts have settled."
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For all other Non-WPS Formulations, including Residential Use
Formulations: "Keep all persons, children and pets out of the treated
area until sprays have dried or dusts have settled."
(2) Personal Protective Equipment; Labeling
• WPS Occupational Uses: For all uses of oryzalin within the
scope of WPS, the minimum PPE requirements for pesticide handlers on all
oryzalin end-use products are:
o coveralls over long-sleeved shirt and long pants
o chemical resistant gloves
O chemical resistant footwear
o chemical resistant headgear for overhead exposures
o chemical resistant apron (mixers and loaders)
• Non-WPS Uses: For all uses of oryzalin outside the scope of
WPS, the minimum PPE requirements for pesticide handlers on all oryzalin
end-use products are:
o coveralls over long-sleeved shirt and long pants
o chemical resistant gloves
o chemical resistant footwear
o chemical resistant headgear for overhead exposures
o chemical resistant apron (mixers and loaders)
• Homeowner Uses: For all homeowner uses, the minimum PPE
requirements are:
o Long-sleeve shirt and long pants
O Chemical resistant gloves
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Other Worker Protection Labeling Requirements
• Reduced PPE when Engineering Controls Used
When handlers use closed systems, enclosed cabs, or aircraft in a
manner that meets the requirements listed in the Worker Protection Standard
(WPS) for agricultural pesticides [40 CFR 170.240(d)(4-6)], the handler PPE
requirements may be reduced or modified as specified in the WPS.
• User Safety Statements
Follow manufacturer's instructions for cleaning/maintaining PPE. If no
such instructions for washables, use detergent and hot water. Keep and wash
PPE separately from other laundry.
Discard clothing and other absorbent materials that have been drenched
or heavily contaminated with this product's concentrate. Do not reuse them.
Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.
Users should remove clothing immediately if pesticide gets inside.
Users should remove PPE immediately after handling this product. As
soon as possible, wash thoroughly and change into clean clothing. Wash the
outside of gloves before removing.
For WPS uses and non-WPS uses do not apply this product in a way that
will contact workers or other persons, either directly or though drift. Only
protected handlers may be in the area during application.
b. Precautionary Label Statement for Fish
In order to provide protection for fish that may be exposed to oryzalin, the
following fish toxicity statement is required:
"This pesticide is toxic to fish. Do not apply this product directly to water, or
to areas where surface water is present or to intertidal areas below the mean
high water mark."
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c. Grazing Restrictions; Labeling
All oryzalin end-use product labels must be amended to include the
following restriction against grazing or feeding crops grown in treated areas to
livestock:
"Do not graze or feed forage from treated fields or orchards to livestock."
d. Changes in Directions for Use; Labeling
All end-use product labels must bear the specific application rates, number of
applications per year, total pounds a.i. per year, and intervals between
applications, as specified in Table 12.
e. Restriction on Aerial Application; Labeling
All end-use product labels must prohibit aerial application except for
agricultural uses in California.
60
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Table 12. Oryzalin Labels - Number of Applications Allowed and Interval Between
Applications
Use
Landscape
ornamentals
Field-grown and
container-grown
ornamentals
Ornamental bulbs
Christmas tree
plantations
Non-croplands
Warm-Season Turf
Florida Turf
All crops for all
soil types
Application Rate
(lb a.i./A)
1.5-2
3-4
2
3
4
0.75- 1.5
2-4
2
4
6
1.5-2
1.5
2-6
Minimum Time
Between
Applications
(months)
2
4
3
3
3
3
2
2
, 4
8
3
3
2.5
Total Amount
Allowed
(lb a.i./A/year)
8
12
8
9
12
3
8
6
12
12
6
4.5
12
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. 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 products bearing
old labels/labeling, i.e., labels absent the modifications specified in this RED document,
except as noted below, 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.
61
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VI. APPENDICES
63
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APPENDIX A. Table of Use Patterns Subject to
Reregistration
Appendix A is approximately 75 pages long and is not being included. Copies of Appendix A
are available upon request per the instructions in Appendix D.
65
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-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
67
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case oryzalin covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to oryzalin 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
O 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.
69
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APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Oryzalin
79
-------
-------
GUIDE TO APPENDIX C
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 Decision. 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.
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.
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.
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 token 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
81
-------
as (19??), the Agency was unable to determine or estimate the date of the
document.
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.
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.
82
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r
BIBLIOGRAPHY
MRID
CITATION
00017945 Turner, ?; Bewley, ?; Johnson, ? (1975) Summary of Data. (Unpublished
study received May 1, 1975 under 1471-96; submitted by Blanco Products Co.,
Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL: 101675-A)
00018372 Griggs, D.; Macy, T.; Davis, N.; et al. (1972) EL-119-Soybeans: Residue
Data on EL-119 3,5-Dinitro-N4,N4-di(n-propyl)sulfanilamide plus Chloramben
(Amiben(R)), Dinoseb (Premerge(R)), and Linuron (Lorox(R)) in Soybean
Foliage and Seed: (Experimental Permit). Summary of studies 210007-C
through 210007-T. (Unpublished study received Sep 15, 1972 under
1471-EX-36; submitted by Elanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, Ind.; CDL:210007-U)
00018373 Sieck, R.F.; Barton, SJ. (1972) Determination of EL-119 in Crops. Method
no. 5801615 dated Mar 29, 1972. (Unpublished study received Sep 15, 1972
under 1471-EX-36; submitted by Elanco Products Co., Div. of Eli Lilly and
Co., Indianapolis, Ind.; CDL: 210007-V)
00023990 Elanco Products Company (1969) Oryzalin-Fruit and Nut Crops. (Unpublished
study received Sep 1, 1976 under 6F1859; CDL: 098067-K)
00026762 Arthur, B.H.; Worth, H.M.; Hoffman, D.G.; et al. (1972) Guinea Pig
Sensitization Study with EL-119: Study G-D-7-72. (Unpublished study
received Dec 12, 1979 under 1471-96; submitted by Elanco Products Co., Div.
of Eli Lilly and Co., Indianapolis, Ind.; CDL:241537-H)
00026772 Kitchen, D.N.; Carter, J.L.; Hoffman, D.G.; et al. (1979) The Toxicological
Evaluation of Oryzalin (Compound 67019) Given to Rats in the Diet for Three
Months: Study R-686. (Unpublished study received Dec 12, 1979 under
1471-96; submitted by Elanco Products Co., Div. of Eli Lilly and co.,
Indianapolis, Ind.; CDL: 241537-S)
00026773 Kitchen, D.N.; Hoffman, D.G.; Todd, G.C.; et al. (1979) The Toxicological
Evaluation of Oryzalin (Compound 67019) Given to Mice in the Diet for Three
Months: Study M-9276. (Unpublished study received Dec 12, 1979 under
1471-96; submitted by Elanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, Ind.; CDL: 241537-T)
83
-------
BIBLIOGRAPHY
MRTO
CITATION
00026780 Blanco Products Company (1979) Interim Status Report: Chronic Feeding
Studies—Repeated Oral Exposure 2-Year Mouse. (Unpublished study received
Dec 12, 1979 under 1471-96; CDL:241537-AE)
00026785 Markham, J.K.; Kitchen, D.N.; Owen, N.V.; et al. (1978) A Teratology Study
on Lilly Compound 67019 (Oryzalin) in the Rabbit: Study B-7366.
(Unpublished study received Dec 12, 1979 under 1471-96; submitted by Blanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:241537-AJ)
00026786 Blanco Products Company (19??) Summary and Conclusions: Oryzalin.
(Unpublished study received Dec 12, 1979 under 1471-96; CDL: 241537-AK)
00031663 Macy, T.; Davis, N.;! Turner, L.; et al. (1974) Surflan-Fruit and Nut
Plantings. (Unpublished study received Aug 1, 1974 under 5G1563; prepared
in cooperation with Univ. of California and others, submitted by Blanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:094266-G)
00031767 Griggs, ?; Sherman, ?; Davis, ? (1973) Surflan plus Sencor-Soybeans.
(Unpublished study received Feb 10, 1973 under 1471EX-36; prepared in
cooperation with Chemagro, submitted by Blanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, Ind.; CDL:210005-D)
00038667 Grogg, J. (1978) Technical Memorandum. (Unpublished study received Apr 4,
1979 under 308-86; submitted by Huntington Laboratories, Inc., Huntington,
Ind.; CDL:242432-A)
00038668 Worth, H.M.; Anderson, R.C., eds. (1971) The Safety Evaluation of Oryzalin,
EL 119. (Unpublished study received on unknown date under 1471-96;
submitted by Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis,
Ind.; CDL:242443-A)
00038672 Blanco Products Company (19??) Subacute Dermal Toxicity Study-Rabbits:
Study B-705-71. (Unpublished study received on unknown date under 1471-96;
CDL:242443-J)
00038883 Griggs, D.; Macy, T.; Davis, N.; et al. (1972) EL-119 Soybeans: Residue Data
on EL-119 3,5-Dinitro-N4,N4-di(n-propyl)sulfanilamide as a Preemergence
Herbicide for Soybeans (Full Registration). Includes method no. 5801615 dated
Mar 29, 1972. (Unpublished study received Dec 29, 1972 under 3F1347;
84
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BIBLIOGRAPfl[Y
MRID
CITATION
submitted by Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis,
Ind.;CDL:093605-A)
00041970 Arthur, B.H. (1968) Letter sent to H.M. Worth dated Mar 21, 1968, Dermal
toxicity and eye irritation—Compound 67019. (Unpublished study received on
unknown date under 1471-96; submitted by Blanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, Ind.; CDL:242443-B)
00042908 Carter, J.L.; Adams, E.R.; Owen, N.V.; et al. (1980) A Multi-Generation
Study with Compound 67019 in the Rat: Studies R-1226, R-327, R-647.
(Unpublished study received Feb 5, 1980 under 1471-96; submitted by Blanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:241742-A)
00044332 Carter, J.L.; Todd, G.C.; Hoffman, D.G.; et al. (1980) The Toxicological
Evaluation of Oryzalin (Compound 67019) Given to Fischer 344 Rats in the
Diet for Two Years: Studies R-167 and R-177. (Unpublished study received
Jul 24, 1980 under 1471-96; submitted by Blanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, Ind.; 099517-A, 099518)
00054464 Eh' Lilly and Company (1976) Oryzalin—Soybeans. (Compilation; unpublished
study received May 4, 1976 under 1471-105; submitted by Blanco Products
Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:229212-G)
00054464 Eh' Lilly and Company (1976) Oryzalin—Soybeans. (Compilation; unpublished
study received May 4, 1976 under 1471-105; submitted by Blanco Products
Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:229212-G)
00066194 Blanco Products Company (1976) Oryzalin and Oryzalin plus Metribuzin
Tank-mix on Soybeans. (Unpublished study received Sep 16, 1977 under
1471-96; CDL:231825-E)
00068079 Carter, J.L.; Owen, N.V.; Todd, G.C.; et al. (1981) The Toxicological
Evaluation of Oryzalin (Compound 67019) Given to B6C3F1 Mice in the Diet
for Two Years: Studies M-9087 and M-9097. (Unpublished study received Apr
2, 1981 under 1471-96; submitted by Blanco Products Co., Div. of Eli Lilly &
Co., Indianapolis, Ind.; CDL:244746-A; 244747; 244748)
00072593 Carter, J.L.; Negilski, D.S.; Kehr, C.C.; et al. (1980) The Toxicity of
Compound 67019 (Oryzalin) to Bobwhite Quail in a Fiveday Dietary Study:
85
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BIBLIOGRAPHY
MRBD
CITATION
Study No. A010-79. Includes undated method ATY. (Unpublished study
received May 7, 1981 under 1471-96; submitted by Blanco Products Co., Div.
of Eli Lilly and Co., Indianapolis, Ind.; CDL:245053-A)
00072595 Sleight, B.H., IE (1971) Acute Toxicity of EL-119 to Bluegill (~ Lepomis
macrochirus ~) and Rainbow Trout (~ Salmo gaird neri ~). (Unpublished
study received May 7, 1981 under 147196; prepared by Bionomics, Inc.,
submitted by Blanco Products Co., Div. of Eli Lilly & Co., Indianapolis, Ind.;
CDL:245055-A)
00072596 Carter, J.L.; Karnak, R.E.; Kehr, C.C.; et al. (1980) The Toxicity of
Compound 67019 (Oryzalin) to — Daphnia magna~in a 48-hour Static Test:
Study Nos. 5005-79 and 5012-79. (Unpublished study received May 7, 1981
under 1471-96; submitted by Blanco Products Co., Div. of Eli Lilly & Co.,
Indianapolis, Ind.; CDL:245056-A)
00086801 Probst, G.S.; Hill, L.E.; Jordan, W.H.; et al. (1981) The Effect of Oryzalin
(Lilly Compound 67019) on the Induction of DNA Repair Synthesis in Primary
Cultures of Adult Rat Hepatocytes: Study 810217-337-UDS. (Unpublished
study received Nov 19, 1981 under 1471-96; submitted by Blanco Products
Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:246259-A)
00089708 Blanco Products Company (1973) Soybeans-Surflan Plus Dyanap.
(Compilation; unpublished study received Nov 19, 1974 under 1471-96;
CDL: 101691-A)
00096361 Decker, O.D.; Sieck, R.F.; Shuey, E.W. (1981) Residue Data on Trifluralin
and Oryzalin When EL-5219 is Used for Preemergence Weed Control in
Soybeans. (Unpublished study received Feb 10, 1981 under 1471-118;
submitted by Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis,
Ind.; CDL:244283-A)
00098461 Jordan, W.H.; Byrd, R.A.; Markham, J.K.; et al. (1982) A Replicated
Teratology Study on Oryzalin (EL-119, Compound 67019) by the Oral Route in
Dutch Belted Rabbits: Study Nos. B7281 and B7291. (Unpublished study
received Apr 8, 1982 under 1471-96; submitted by Blanco Products Co., Div.
of Eli Lilly and Co., Indianapolis, Ind.; CDL:247229-A)
86
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BIBLIOGRAPHY
MRID
CITATION
00098462 Cochrane, R.L.; Kehr, C.C.; Jordan, W.H.; et al. (1982) The Toxicity of
Oryzalin (EL-119, Compound 67019) to Bobwhite in a 14day Acute Oral
Study: Study A02980. (Unpublished study received Apr 8, 1982 under
1471-96; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, Ind.; CDL:247229-B)
00105707 Interregional Research Project No. 4 (1978) Oryzalin/Trifluralin: Residues in
Peas. (Compilation; unpublished study received Jun 4, 1979 under 9E2219;
CDL:098322-A)
00106657 Elanco Products Co. (1974) Analyses for Residues of Surflan Plus Lorox or
Sencor in Soybeans. (Compilation; unpublished study received Jun 11, 1974
under 1471-96; CDL:024961-A)
00106664 Arthur, B.; Worth, H., ed. (1971) Subacute Dermal Toxicity Study-Rabbits:
Study B-705-71. (Unpublished study received Jun 18, 1972 under 2G1201;
submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:091019-G)
00106670 Owen, N. (1968) Oryzalin: Dog Study D-100-67. (Unpublished study received
Jun 18, 1972 under 2G1201; submitted by Elanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, IN; CDL:091019-M)
00106681 Arthur, B. (1971) Dermal Toxicity and Eye Irritation-Surflan (Research No.
67019). (Unpublished study received Dec 29, 1972 under 3F1347; submitted
by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:093606-C)
00106685 Sieck, R.; Barton, S.; Davis, N.; et al. (1974) Residue Data on Surflan for
Weed Control in Cotton in Texas. (Unpublished study received on unknown
date under 5F1542; submitted by Elanco Products Co., Div. of Eli Lilly and
Co., Indianapolis, IN; CDL: 094198-A)
00106691 Elanco Products Co. (1976) The Results of Tests on the Amount of Residue
Remaining, Including a Description of the Analytical Method Used: Surflan
75W. (Compilation; unpublished study received Sep 1, 1976 under 1471-96;
CDL:095264-B)
87
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BIBLIOGRAPHY
MRTO
CITATION
00106727 Blanco Products Co. (1972) Summary of Data: EL-119. (Compilation;
unpublished study received Dec 22, 1972 under 3F1347; CDL:092131-AH)
00106730 Ward, N.; Donoho, A.; Sullivan, W. (1971) Determination of Oryzalin in
Crops: Procedure 5801603. (Unpublished study received 1971 under unknown
admin no.; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, IN; CDL:125165-A)
00106732 Golab, T.; Ward, N.; Donoho, A.; et al. (1971) Oryzalin As a Preemergence
Surface-applied Herbicide for Soybeans. (Unpublished study received Sep 27,
1971 under 1471-EX-36; submitted by Blanco Products Co., Div. of Eli Lilly
and Co., Indianapolis, IN; CDL:210006-B)
00106735 Johnson, W.; Sieck, R.; Barton, S. (1976) Residue Data on Oryzalin in
Soybeans when Surface Applied as a 2EC Formulation. (Unpublished study
received Mar 17, 1976 under 1471-EX-53; submitted by Blanco Products Co.,
Div. of Eli Lilly and Co., Indianapolis, IN; CDL:224395-C)
00106738 Johnson, W.; Sieck, R.; Barton, S. (1976) Residue Data on Oryzalin in Winter
Wheat Seed When Applied as an Overtop Spray after Wheat is Fully Tillered up
to Time of Heading. (Unpublished study received May 26, 1976 under
1471-EX-58; submitted by Blanco Products Co., Div. of EH Lilly and Co.,
Indianapolis, IN; CDL:226087-B)
00115743 Hoyt, J.; Jordan, W.; Owen, N. (1982) A Dominant Lethal Study with
Oryzalin ... in the Wistar Rat: Study R06082. (Unpublished study received Oct
21, 1982 under 1471-96; submitted by Blanco Products Co., Div. of Eli Lilly
and Co., Indianapolis, IN; CDL: 248616-A)
00126840 Depker, O.; Sieck, R.; Shuey, E. (1983) Oryzalin Residue Data on Wheat
Straw, Wheat Grain, and Milled By-products When Surflan 4AS is Applied as
an Over-top Spray for Weed Control: I-ODD-8301. (Unpublished study
received Apr 14, 1983 under 1471-96; submitted by Blanco Products Co., Div.
of Eli Lilly and Co., Indianapolis, IN; CDL:071520-C)
00126841 Sauter, S.; Meyerhoff, R.; Jordan, W.; et al. (1983) The Toxicity of Oryzalin
(EL-119, Compound 67019) in Water to Fathead Minnows ... in a 34-day Early
Life-stage Study: Study F11482. (Unpublished study received Apr 14, 1983
-------
BIBLIOGRAPHY
MRID
CITATION
under 1471-96; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, IN; CDL:071521-A)
00126842 Meyerhoff, R.; Sauter, S.; Jordan, W.; et al. (1983) The Toxicity of Oryzalin
(EL-119, Compound 67019) in Water to Rainbow Trout... in a 66-day Early
Life-stage Study: Study F11382. (Unpublished study received Apr 14, 1983
under 1471-96; submitted by Elanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, IN; CDL:071521-B)
00129004 Decker, O. (1981) Residue Data on Oryzalin in Wheat Grain, Wheat Straw,
and Barley Grain when Surflan 75W Is Applied as an Overtop Spray for Weed
Control. (Unpublished study received Jim 16, 1983 under 1471-96; submitted
by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:071712-A)
00130427 Rexroat, M.; Jordan, W.; Probst, G.; et al. (1983) The Effect of Oryzalin
(Compound 67019) on the Induction of Reverse Mutations in Salmonella
typhimuriurn Using the Ames Test: Study 830214AMS1188. (Unpublished
study received Aug 11, 1983 under 1471-96; submitted by Elanco Products
Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:251210-A)
40024801 Jordan, W. (1986) A One Year Chronic Oral Toxicity Study of Oryzalin
(Compound 67019, EL-119) in Beagle Dogs: Study 6180-102: D00385.
Unpublished study prepared by Hazleton Laboratories America, Inc. and Eli
Lilly & Co. 765 p.
40454801 Decker, O.; Hudson, J. (1987) Physical and Chemical Characteristics of
Technical Oryzalin: Lab. Proj. ID ODD8723. Unpublished study prepared by
Lilly Research Laboratories. 5 p.
40455001 Day, E.; Coghlan, M. (1987) Product Identity and Composition of Technical
Oryzalin: Laboratory Project ID EWD8746. Unpublished study prepared by
Lilly Research Laboratories. 5 p. ,
40455002 Hudson, J. (1987) Surflan Technical ...: Physical and Chemical Characteristics:
Study Number T1P908707. Unpublished study prepared by Lilly Research
Laboratories. 6 p.
89
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BIBLIOGRAPHY
MRID
CITATION
40744901 Day, E. (1988) Product Identity and Confidential Statement of Formula for
Technical Oryzalin: Laboratory Project ID EWD8810. Unpublished study
prepared by Lilly Research Laboratories. 4 p.
40744902 Day, E. (1988) Analysis and Certification of Ingredients for Oryzalin
Technical: Laboratory Project ID EWD8811. Unpublished study prepared by
Lilly Research Laboratories. 7 p.
40744903 Rutherford, B. (1988) Manufactured Product Characterization of Technical
Oryzalin: Laboratory Project ID BSR8703. Unpublished study prepared by
Lilly Research Laboratories. 30 p.
40744904 Rutherford, B. (1988) Corporate Control Laboratory Procedure for Oryzalin
Technical, QA155H, I.D. 5860: Laboratory Project ID BSR8816. Unpublished
study prepared by Lilly Research Laboratories. 12 p.
40787501 Magnussen, J. (1988) Laboratory Studies of Carbon 141 Oryzalin
Accumulation in Fish: Laboratory Project ID's ABC-0393: ABC-0394.
Unpublished study prepared by Lilly Research Laboratories, Inc. 59 p.
41034201 Jordan, W.; Markey, T. (1988) The Acute Inhalation Toxicity of Oryzalin
(EL-119, Compound 067019) in the Fischer 344 Rat: Project ID: R-H-001-88.
Unpublished study prepared by Lilly Research Laboratories. 36 p.
41050001 Gohdes, M. (1989) Artificial Sunlight Photodegradation of Ocarbon 14-Oryzalin
on Soil: Amendment No. 1 to the Final Report: Project ID: HLA 6237-102.
Unpublished study prepared by Hazleton Laboratories America, Inc. Ill p.
41050101 Jordan, W.; Richardson, K.; Kokkino, A. (1988) The Effect of Oryzalin
(EL-119, ...) on the Induction of Reverse Mutations in Salmonella typhimurium
and Escherichia coli Using the Ames Test. Unpublished study prepared by Lilly
Research Laboratories. 27 p.
41115501 Biehn, W. (1988) Oryzalin-Magnitude of Residue on Papaya: Project ID: IR-4
PR 1410. Unpublished study prepared by University of Hawaii. 158 p.
41125501 Day, E.; Coghlan, M.; Rutherford, B. (1989) Response to EPA Product
Chemistry Review for Oryzalin: Lab Project ID No. EWD8902. Unpublished
study prepared by Lilly Research Laboratories. 8 p.
90
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BIBLIOGRAPHY
MRID
CITATION
41163801 Jordan, W.; Byrd, R. (1989) A Developmental Toxicity Study of Oryzalin
(EL-119, Compound 067019) Administered Orally to CD Rats: Project ID:
R37988. Unpublished study prepared by Lilly Research Laboratories. 377 p.
41278701 Gohdes, M. (1989) Artificial Sunlight Photodegradation of Carbon 14-Oryzalin
in a Buffered Aqueous Solution: Lab Project Number: HLA/6237/103.
Unpublished study prepared by Hazleton Laboratories America, Inc. 115 p.
41289901 Oberly, T.; Garriott, M. (1989) Response to the Environmental Protection
Agency's Review of an Ames Test with Oryzalin (EL-119, Compound 67019).
Unpublished study prepared by Lilly Research Laboratories lip.
41322801 Graper, L.; Rainey, D. (1989) Aerobic Metabolism of carbon 14 Oryzalin in
Sandy Loam Soil: Lab Project Number: ABC/0434. Unpublished study
prepared by DowElanco 33 p.
41322802 Graper, L.; Rainey, D. (1989) Anaerobic Metabolism of carbon 14 Oryzalin in
Sandy Loam Soil: Lab Project Number: ABC/0435. Unpublished study
prepared by DowElanco 26 p.
41378401 Saxena, A. (1990) Hydrolysis of Oryzalin in Buffered Aqueous Solutions: Final
Report: Lab Project Number: HLA 6313-100. Unpublished study prepared by
Hazleton Laboratories America, Inc. 52 p.
41479801 Saunders, D. (1990) Oryzalin Aged Soil Leaching Study: Lab Project Number:
AAC8923. Unpublished study prepared by DowElanco, Plant Science
Chemical Development. 57 p.
41479802 Saunders, D.; Powers, F. (1987) Adsorption and Desorption of Oryzalin on
Soil: Lab Project I.D.: EWD8726. Unpublished study prepared by Lilly
Research Laboratories. 66 p.
41630301 West, S. (1990) Frozen Storage Stability of Oryzalin in Crops and Processed
Products: Lab Project Number: SDW9007. Unpublished study prepared by
DowElanco. 83 p.
41630302 West, S. (1990) Validation Data for the Determination of Oryzalin in Crops and
Processed Products by Method Number AM-AA-CA-R134AA-755: Lab Project
Number: SDW9008. Unpublished study prepared by DowElanco. 69 p.
91
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BIBLIOGRAPHY
MQEttD
CITATION
41733701 Baron, J. (1990) Oryzalin: Magnitude of Residue on Guava: Lab Project
Number: 1346. Unpublished study prepared by University of Hawaii. 199 p.
41859701 Day, E.; Griggs, R.; Decker, O. (1990) Oryzalin Terrestrial Field Dissipation
Study-An Interim Report: Lab Project No: AAC8914. Unpublished study
prepared by DowElanco, Formulation and Chemistry Lab. 48 p.
41906001 Mester, T. (1990) Oryzalin (LX199-02) Raw Agricultural Commodity Study on
Apples in New York, Michigan, Washington and North Carolina: Lab Project
Number: AAC8829: 1714-88-99-02-02B-12: 171488-99-02-02B-15.
Unpublished studies by DowElanco, Environmental Chemistry Laboratory.
296 p.
41906002 Mester, T. (1990) Oryzalin (LX199-02) Processed Commodity Study on Apples
in Washington and New York: Lab Project Number: AAC8830:
1714-89-99-02-02B-20: 1714-89-99-02-02B-21. Unpublished study prepared
by DowElanco, Environmental Chemistry Laboratory. 259 p.
41906004 Mester, T. (1990) Oryzalin (LX199-02) Raw Agricultural Commodity Study on
Grapes in New York, Michigan, California, Washington and North Carolina:
Lab Project Number: AAC8833: 1714-88-99-0203B: 1714-88-99-02-03B-32.
Unpublished study prepared by DowElanco, Environmental Chemistry
Laboratory. 365 p.
41906005 Mester, T. (1990) Oryzalin (LX199-02) Raw Agricultural Commodity Study on
Pears in California, Washington and North Carolina: Lab Project Number:
AAC8830: 1714-89-99-02-02C-01: 1714-89-99-0202C-02. Unpublished study
prepared by DowElanco, Environmental Chemistry Laboratory. 248 p.
41906006 Mester, T. (1990) Oryzalin (LX199-02) Raw Agricultural Commodity Study on
Blueberries in Michigan, New Jersey, Georgia, North Carolina and
Washington: Lab Project Number: AAC8832: 1714-88-9902-03E-24:
1714-89-99-02-03E-04. Unpublished study prepared by DowElanco,
Environmental Chemistry Laboratory. 380 p.
42050001 Mester, T. (1991) Oryzalin (LX199-02) Raw Agricultural Commodity Study on
Raspberries in Oregon and Washington:. Lab Project Number: AAC8831:
I714-89-99-02-03D-10: 1714-89-99-02-03D-12. Unpublished study prepared
by Northwest Agricultural Research, Inc. and DowElanco. 280 p.
92
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BIBLIOGRAPEIY
MRID
CITATION
42064901
42064903
42064904
42137901
42158501
42158502
42401501
42558201
42602401
Graper, L. (1991) Nature of Ccarbon 141 Oryzalin Residues in Bovine Tissue
and Milk: Lab Project Number: ABC 0457/0458. Unpublished study prepared
by DowElanco,. 49 p.
West, S. (1991) Gas Chromatographic Determination of Oryzalin in Meat, Milk
or Eggs: Lab Project Number: AM-AA-CA-RO77-AA-755. Unpublished study
prepared by DowElanco. 22 p.
West, S. (1991) Determination of Oryzalin in Meat, Milk or Eggs by
High-Performance Liquid Chromatography: Lab Project Number:
AMAA-CA-R078-AA-755. Unpublished study prepared by DowElanco. 22 p.
Saunders, D.; Elliott, S.; Emery, K. (1991) Exposure of Mixer/Loaders and
Applicators to Oryzalin from Application of Surflan 85DF with a Groundboom
Sprayer: Lab Project Number: AAC8508. Unpublished study prepared by Lilly
Research Labs. 349 p.
Handy, P.; Coghlan, M. (1991) Response to EPA Product Chemistry Review
for Oryzalin: Lab Project Number: PRH9108. Unpublished study prepared by
DowElanco. lip.
Graper, L. (1991) Nature of Carbon 14 Oryzalin Residues in Chickens: Lab
Project Number: MET91026. Unpublished study prepared by DowElanco
103 p.
Hoyt, J.; Beckhelm, G.; Jordon, W. (1992) A One-Generation Study in Fischer
344 Rats Maintained on Diets Containing Oryzalin (EL-119, Compound
067019): Lab Project Number: R21990: R10991. Unpublished study prepared
by Lilly Research Labs, Inc. 1139 p.
Rainey, D. (1992) Nature of Residue in Grapes Treated with carbon 14
Oryzalin: Lab Project Number: ABC0453. Unpublished study prepared by
DowElanco. 19 p.
Feutz, E. (1992) Evaluating the Effects of Oryzalin on the Germination,
Emergence, and Vegetative Vigor of Non-target Terrestrial Plants: Lab Project
Number: 40292. Unpublished study prepared by ABC Labs, Inc. 155 p.
93
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BIBLIOGRAPHY
MUD
CITATION
42784102 Bridge, T.; Lobb, K. (1982) Percutaneous Absorption of (carbon 14)-Oryzalin
in Monkeys: Lab Project Number: DMR052193A. Unpublished study prepared
by Toxicology Division, Lilly Research Labs. 30 p.
43207001 Jordan, W.; Bridge, T.; van Lier, R. (1983) Percutaneous Absorption of
(carbon 14)-Oryzalin (EL-119, Compound 67019) in Monkeys: Lab Project
Number: AWH041894: P03382: P04082. Unpublished study prepared by Lilly
Research Labs, Toxicology Division. 48 p.
94
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APPENDIX D. List of Available Related Documents
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The following is a list of available documents related to oryzalin. 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 oryzalin 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. Oryzalin RED Fact Sheet (included in this RED)
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
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APPENDIX E. PR Notices 86-5 and 91-2
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PR Notice 86-5
101
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29,1986
PR NOTICE 86-5
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Persons 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 §lO(d)(l). This Notice does not apply to commercial, financial, or
production information, which are, and must continue to be, submitted differently under
separate cover.
.III. 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 (40jCFR §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
confidentiality. 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 entire proposed regulation becomes final. Adequate
lead time is being provided for submitters to comply with the new requirements.
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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 compatible 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 costs 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 application packages the data formatting
requirements described herein.
OPP has also established a public docket which imposes deadlines for inserting into 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 of all applicable data requirements and an indication of how each is
satisfied—the statement of the method of support for 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 follows the index on the next
page, and samples of some of the requirements are attached. Except for the language of 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-
A.
B.
C.
D.
Text Example
Page Page
17
Organization of the Submittal Package ................................ 3
Transmittal Document ............ .............................. 4
Individual Studies ............................................. 4
C. 1 Special Considerations for Identifying Studies .................. ..... 5
Organization of each Study Volume ............. .................... 6
D. 1 Study Title Page ..................... .' .................... 7
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10(d)(l)) .................................. 8
D. 3 Confidential Attachment ..................................... 8
D. 4 Supplemental Statement of Data Confidentiality
17
12
13
15
104
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Claims (other than those based on FIFRA §10(d)(l)) 8
D. 5 Good Laboratory Practice Compliance Statement 9
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
14
16
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at the same time for 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 administrative material must be grouped 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 transmittal document. This
document identifies the submitter or all joint submitters; the regulatory action in support of
which the package is being submitted—i.e., a registration application, petition, experimental
use permit (EUP), §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 package in the order of their
appearance, showing (usually by Guideline 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 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.
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When a submittal package supports a tolerance petition 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 completeness. A study should be identifiable and distinguishable
by a conventional bibliographic citation including author, date, and title. Studies generally
correspond in scope to a single Guideline requirement for supporting data, with some
exceptions discussed in section C.I. Each study included in a submittal package must be
bound as a separate entity. (See comments on binding 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 volumes 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.I 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 tnese cases each species tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed analyses, historical control
data, and the like are often associated 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 ot 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 produced from unregistered source ingredients, should be bound as a single
study for each Guideline series (61, 62, and 63) for conventional pesticides, or for the
equivalent subject range lor biorati9nal pesticides. The first of the three studies in a complete
product chemistry submittal for a biochemicalpesticide 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 would cover Guidelines 151-23 and
151-25; the third would cover Guideline 151-26.
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Note particularly that product chemistry studies {ire likely to contain Confidential
Business Information as defined in FIFRA §10(d)(l)(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, however, of limiting a study to
the report of a single investigation 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
commodities 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
Always
One of the two alternative
forms of this statement
is always required
If study reports laboratory
work subject to GLP require-
ments
For certain toxicology 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)(l)(A), (B), or (C)
Example
Page 12
Page 13
Page 16
CBI Attachment
Supplemental Statement
of TJata Confidentiality
Claims
If CBI is claimed under FIFRA
§10(d)(l)(A), (B), or (C)
Only if confidentiality is
claimed on a basis other than
FIFRA §10(d)(l)(A), (B), or (C)
Page 15
Page 14
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
107
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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 content
of 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 Identification. 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 it it responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the previously 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 published document, identity on the
title page all relevant tacts of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA §10(d)(l).
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)(l)(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. Do not make CBI claims with
respect to analytical methods associated with pet-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 of 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 to the Confidential Attachment
must oe associated with a specific cross reference to the page(s) in the main body of the study
108
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o» which it is cited, and with a reference to the applicable passage(s) of FIFRA §10(d)(l) 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 of Data Confidentiality Claims must be submitted,
identifying each passage claimed confidential and describing in detail the basis for the
claim. A list ofthe 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. Samples 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 uis to 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 previously submitted studies
should not be included in the transmittal document, but should be incorporated into the
statemenfof 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 on one side only in black ink, with high contrast and good resolution. Bindings
for individual studies must be secure, but easily removable to permit disassembly for
microfilming. Check with EPA for special instructions before 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 proposed regulations specified two copies; three are now
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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 Standard or Special Review
must be provided in four copies, from 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)(l)(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".
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.
Attachment 2.
Attachments.
Attachment 4.
Attachment 5.
Attachment 6.
Attachment 7.
Sample Transmittal Document
Sample Tide Page for a Newly Submitted Study
Statements of Data Confidentiality Claims
Supplemental Statement of Data Confidentiality Claims
Samples of Confidential Attachments
Sample Good Laboratory Practice Statements
Format Diagrams for Submittal Packages and Studies
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1.
ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
Name and address of submitter (or all joint submitters**)
+Smith Chemical Corporation
1234 West Smith Street
Cincinnati, OH 98765
-ahd-
Jones Chemical Company
5678 Wilson Blvd
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 correspondence 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 joint 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:
Company Name
Company Contact:
Signature
Name
Name
Fhone
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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
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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)(l)(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.
6S10(d) (1) (A), (B), or (C) .
Company
Company Agent:
Title
Typed Name
Date:
Signature
2. Claim of confidentiality under FIFRA §10(d)(l)(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 Methods Manual, and therefore cannot be claimed as confidential. QPP
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)(l)(A), (B),
or (C), but for which you claim confidential treatment on another basis, the following
information 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 conf '
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 connection with those disclosures.
Enclose copies of any pertinent determinations of confidentiality made by EPA,
other Federal agencies, of courts concerning this information.
If you assert that disclosure of this information would be likely to result in
substantial harmful effects to you, describe those harmful effects and explain
why they should be viewed as substantial.
If you assert that the information in voluntarily submitted, 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 PHRASED Ethylene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
28
100
14 Identity of Inert Ingredient
25 "
19
§10(d)(C)
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5
DELETED PARAGRAPH(S):
This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
PAGE
20.
Reproduce the deleted paragraph(s) here
LINES REASON FOR THE DELETION
2-17 Description of the quality control process
FIFRA REFERENCE
Examples. (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
35-41. Description of product manufacturing process
FIFRA REFERENCE
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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:
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.
Submi 11 e r
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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
„-•--'
LEGEND
* When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
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PR Notice 91-2
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.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 policy 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
of 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 n9minal
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 _ orily
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 g©9d 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 legeilly 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 composition 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 n9t 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 concentration 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 actiye, 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
Alltpesticides are required to be efficacious. Therefore,
the certified lower limits may n9t 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 haye 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 dela.y 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
11 Conversion to Nominal Gonceritrations 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
27 JAN 1995
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 in 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 ffl-B); or
3. Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section fll-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 ofyour 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 HI - 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- ttFA Grouping ot iind-Use Froclucts for Meeting Acute Toxicology Data
Requirements tor Keregistrattori
5 - &FA. Acceptance criteria
6 - List ot Registrants Receiving This Notice
7- Uost 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 supp_ort 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 produces) containing the subject active ingredients.
SECTION H. DATA REQUIRED BY THIS NOTICE
H-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.
H-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..
n-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
OECD 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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H-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED
BY THfc AGiilNCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of any previouTTJata Call-fn(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 avoia issuance of a Notice of Intent to Suspend their affected
products.
SECTION m.
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).
HI-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.
m-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 Genenc 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 in-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-Call-in Response Form, and the Requirements Status and Registrant's Response Form,
(contained in Attachments 2 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 Genenc Data Exemption or are not requesting voluntary cancellation
of your registration(s). 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 (it this form is required) and initial any subsequent pages. The
torms contain separate detailed instructions on the response options. Do not alter the printed
material. If you have questi9ns or need assistance in preparing your response, call or write the
contact persoii(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 tlie 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 lor amendment, a copy oi 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 for amending registrations may be obtained from the
Registration Support Branch, Registration Division, Office of Pesticide Programs, EPA, by
calling (703)308-?"~
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 wijQ. 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 tor responding to product specific
data requkements.
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(s) who have committed to
generate and submit the required data fail to take appropriate steps to meet requirements or are
no longer in compliance with this 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 ni-C.l. of this Notice and cpmprise 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 rorm. 11 you choose item 6b (agree to satisty
the generic data requirements), you must submit the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form as v/ell 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 m-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 torms
as well as any other inrormation/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 1H-C.2. A discussion of
options relating to requests for data waivers is contained in Section ffi-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 youir response. These forms are the
Data-Call-in Response Form, and the Requirements Status ana Registrant's Response Form,
for product specific data (.contained in Attachments 2 and 3, respectively). The JJata Call-in
Response Form must be submitted as part of every response to mis 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 Call-in Response Form unless 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 ana Registrant's
Response Form (11 this t9rm is required) and initial any subsequent pages, ihe 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 ofthis option. Voluntary cancellation is item number 5 on both the
Generic and Product Specific Data Call-In Response Forms. If you choose this
option, you must complete both L)ata 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
specmc data requirements lor an MUP or EUP as applicable) on the product specific Data
Call-in Response Form. Note that the options available for addressing product specificHafa
requirements diner 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 IH-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 uall-In
Response Form ana tne Requirements Status and Registrant's Response Form as well as any
other mrormation/data pertaining to the option chosen to address me data requirement. Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1.
Generic Data
If you acknowledge 9n the Generic Data Call-In Response Form that you agree to
satisfy the generic data requirements (i.e. you select item numoer obj, then you must select
one of the six options 9n 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 f9r 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 wiish 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 laboratories) 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 tor the submission ot completea 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. Informally, 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
registrants) 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 C9st-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 aroitration as provided by FIFRA section
3(c)(2)(BXiii) 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 tins Notice.
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 oilier 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 S9me 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 lo submil, 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 sludy. (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 thai sludy. In ihe evenl thai exacl
Iranscripls of raw dala have been prepared (e.g., lapes 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
data1 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 of 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 number 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 7a or 76), 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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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 — The requirements for developing product specific data are the
same as those described tor generic data (see Section ni.C.l, 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
ni.C.l, 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 opHon.
Option 3. Offer to Share in the Cost of Data Development --The same requirements for
generic data (Section lll.U.l., Option 6) apply to tins 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.U.l., Uption 4) apply to this option for product specific data.
Option 5. Upgrading a Study — The same requirements described for generic data (see Section
iil.u.i., Uption 5) apply to this option for product specific data.
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section lli.u.l., Uption 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 andthe
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (m.u.i.), 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 ttFA~to consider me appropriateness ol
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 19 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 produces)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of produces) containing the active ingredient (folbwing 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 9pposed 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 ot this Notice within the time frame provided by
this Motice. Witnm 3U days ot 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 lor product
chemistry, acute toxiciry 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 submitte3~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
NOTICE
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 oy Section ni-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, andthe 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
141
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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
UNREASONABLE 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(s) 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 horms
(Attachment 3;, for both (generic ana product specific data) and any 9ther 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,
rouis $. True, JrV^ Acting Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are:
1 - Data Call-in Chemical Status Sheet
2- Generic Data Call-in and FroducfSpecific Data Call-in Response Forms with
Instructions
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status
and Registrant's Response ^orms with instructions
4 - EPA Grouping of Jind-use Products for Meeting Acute Toxicology Data
Kequirements tor Keregistration
5 - ttFA Acceptance Criteria
6 - List ot Registrants Receiving This Notice
7 - Confidential statement ot Formula, Cost Share and Data Compensation Forms
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Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms (Form B inserts)
and Instructions
155
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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 7a and 7b are not applicable for Generic Data.
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
~~ Uenenc and Product Specific Data ualFIn
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 spatce 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.
153
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic ana Froduct Specific '
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 stam"'1
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 rorms. 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
or. 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 ana product Specitic Data UaTFIn
incorporate thatproduct 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 anv
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.
152
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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 Forau"
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
RodeSticide 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 preprinted these
forms with a number of items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed by
l^regSt as appropriateP Items 8 through 11 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 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 Uiiei,
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.
151
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Attachment 2. Combined Generic and Product Specific
Data Call-In Response Forms (Form A inserts) Plus
Instructions
149
-------
ORYZALIN DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing oryzalin.
. J5is Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by tnis notice, ana point or contact tor inquiries pertaining to the reregistration of
SPSntW /$?,»£P men*£S t0-£e ^ed in conjunction with (1) the Product Specific Data Call-
in Notice, (2) the Product Specific Data Call-In Response Form (Attachment^) (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) me EPA
SSWrtSf n nJecla (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (/) the Lost Share and Data Compensation Forms in replying to this oryzalin Product
Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
. Th? additional data requirements needed to complete the database for oryzalin are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency
has concluded that additional aata on oryzalin are needed for specific products These data are
f!^,1™!?0! * s«bimtted to the Agency within the time frame fisted. These data are needed to
fully complete the reregistration of all eligible oryzalin products.
INQUIRIES AND RESPONSES TO THIS NOTICE
Judith ciombs7t\7S^OS^46rGSardiTiS ^ generic database of oryzalin, please contact
~™ A If y°U<.hureuanyt?ue^°xTs regarding the product specific data requirements and
^703) reS estabhshed by mis Notice, please contact Franklin Gee at (703) 308-8008.
All responses to this Notice for the Product Specific data requirements should be -
submitted to:
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: oryzalin
148
-------
ORYZALIN DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have produces)
containing oryzalin.
This Generic Data Call-in Chemical Status Sheet, contains an overview of data
required by this notice, and point ot contact tor inquiries pertaining to the reregistration of
oryzalin. 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 oryzalin Generic Data Call In (Attachment h).
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE .
The additional data requirements needed 19 complete the generic database for oryzalin
are contained in the Requirements Status and Registrant's Response, Attachment C. The
Agency has concluded that additional toxicology, occupational ana residential exposure,-
ecological effects, environmental fate and residue chemistry data on oryzalin are needed.
These data are needed to fully complete the reregistration of all eligible oryzalin 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 Judith Coombs at (703) 308-8046.
All responses to this Notice for the generic data requirements should be submitted to:
Judith Coombs, Chemical Review Manager
RB/Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: oryzalin
147
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Attachment 1. Chemical Status Sheets
145
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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 Pro^ip 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 reregisjration 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 preprinted
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 preprinted 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, garnering 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.
157
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Uenenc ana 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 how listed under 40 CFR 158.155
through 158.180, Subpartc.
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 HI 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 FORMS"~
Uenenc and rroauct Specific Data Call-in
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
158
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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;
K Residential
L Indoor food
M Indoor non-food ;
N Indoor medical =
O 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 %
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade Active
Ingredient . .
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute 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
TEP/MET
TEP/PAI/M
TGAI
TGAI/PAI
TGAI/PAIRA
TGAI/TEP
MET
IMP
DEGR
159
-------
Item 9.
date of receipt. However, your response to the Data Call-In itself is due 90
days from the date of receipt.
ON BOTH FORMS: Enter the appropriate Response Code or Codes to show
how you intend to comply with each date 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 submittaTof this study as
outlined in the Data Call-in N9tice 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 nas 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 Call-In Notice and I have
attached the needed supporting information along with this response.
160
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Option 5. ON BOTH FORMS: (Upgrading a Study) I will submit by the
specified due date, or will cite data te-upgrade a study mat EPA has
classified as partially acceptable amd 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 ofjhe 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 hiPA 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 mat 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 moire 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|F
form.
FOR THE GENERIC DATA FORM ONLY; The following;three options
(TSumiaers 7, », and y) are responses mat apply only to the ^Requirements Status
and Registrant's Response Form" for generJcaata.
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 otner ttian lowvoiume 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 tftat applies to me "Requirements Status and Registrant's Response
Form" for product specific data.
161
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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 or 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 cases, please supply all relevant details so that the Agency can ensure that its records are correct.
162
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
163
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EPA'S BATCHING OF PRODUCTS CONTAINING ORYZALIN AS THE ACTIVE
INGREDIENT FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing the active ingredient oryzalin
(3,5-dinitro-N4,N4-dipropylsulfanilamide) the Agency has batched products which can be
considered similar in terms of acute toxicity. Factors considered in the sorting process include
each product's active and inert ingredients (identity, percent composition and biological activity),
type of formulation (e.g., emulsinable concentrate, aerosol, wettable powder, granular, etc.), and
labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the Agency
is not describing batched products as "substantially similar" since some products within a batch
may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute lexicological studies to represent all the products within that batch.
It is the registrants' option to participate in the process with all other registrants, only some of the
other registrants, or only their own products within a batch, or to generate all the required acute
lexicological studies for each of their own products. If a registrant chooses to generate the data
for a batch, he/she must use one of the products within the batch as the test material. If a
registrant chooses to rely upon previously submitted acute loxicily data, he/she may do so
provided thai Ihe dala 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 dala is generated or existing data is referenced, registrants musl
clearly identify Ihe test material by EPA Registration Number. If more than one confidential
slalement of formula (CSF) exists for a product, Ihe regislraril musl indicate the formulation
actually tested by identifying Ihe corresponding CSF,
In deciding how to meel the product specific data requiremenls, registrants must follow Ihe
directions given in Ihe Dala Call-In Notice and ils allachmenls 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 firsl form, "Dala Call-In Response," asks whether Ihe regislranl will meel
the dala requiremenls for each product The second form, "Requiremenls Slalus and Registrant's
Response, lists the producl specific dala required for each producl, including the slandard six
acute toxicity lesls. A registrant who wishes to participate in a batch musl decide whelher he/she
will provide the data or depend on someone else to do so. If a regislranl supplies Ihe dala to
support a balch of products, he/she must selecl one of the following options: Developing Dala
(Option 1), Submitting an Existing Sludy (Option 4), Upgrading an Existing Sludy (Option 5) or
Citing an Existing Sludy (Option 6). If a registrant depends on another's dala, he/she musl
choose among: Cosl Sharing (Option 2), Offers to Cosl Share (Option 3) or Citing an Existing
Study (Option 6). If a regislranl does nol want to participate in a balch, Ihe choices are Options
1, 4, 5 or 6. However, a registrant should know that choosing nol to participate in a batch does
not preclude olher regislranls in Ihe balch from citing his/her sludies and offering to cosl share
(Option 3) ihose sludies.
Table 1 displays Ihe balches for Ihe active ingredienl oryzalin.
165
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Batch
2
3
4
S
6
EPA Reg. No.
34704-442
62719-158
62719-112
62719-113
62719-141
802-564
802-565
62719-140
9198-89
9198-90
55615-2
55615-3
62719-106
62719-110
62719-138
62719-153
62719-183
Active Ingredient (s)
oryzalin 1.0%
oryzalin 1.0%
oryzalin 40.4%
oryzalin . 40.4%
oryzalin . . . 2.84%
oryzalin 2 . 84%
oryzalin 3 . 00%
oryzalin 0.86%
N-Butyl-N-ethyl-a , a, a-
trifluoro-2, 6-dinitro-p-
toluidine 0.86%
N-Dutyl-N-ethyl-cjt, a, a-
trif luoro-2, 6-ainitro-p-
toluidine .'..0.57%
oryzalin 0.75%
oryzalin 75.0%
oryzalin 85.0%
oryzalin 85.0%
Formulation Type
granular
granular
liquid
liquid
liquid
liquid
liquid
liquid
granular
granular
granular
granular
granular
granular
granular
granular
granular
Table 2 lists those products the Agency was u nable to batch. These products were either considered
not to be similar to other products for purposes of acute toxicity or the Agency lacked sufficient
information for decision making. Registrants of these pr oducts are responsible for meeting the acute
toxicity data requirements for each product.
Table 2.
EPA Reg. No.
524-449
961-349
Active Ingredient (s)
11.8%
J% ^
0.96%
N-butyl-N-ethyl-a, a, a-
trifluoro
-2, 6-dinitro-p-toluidme
0.96%
Formulation Type
166
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EPA Reg. No.
Active Ingredient(s)
Formulation Type
961-350
oryzalin ............
0.865%
N-butyl-N-ethyl-a, a, Ct-
trifluoro
. -2,6-dinitro-p-toluidine
orvzalin
1.00%
ooryzalin
^rvzalin ............
N7butyl-N-ethyl-a,a, a-
.trifluoro
-2,6-dinitro-p-toluidine
orvzalin
1.00%
N-butyl-N-ethyl-a, a, a-
trifluoro
-2,6-dinitro-p-toluidine
orvzalin
0.86%
N-butyl-N-ethyl-a, a, a-
tnfluoro
-2,6-dinitro-p-toluidine
oryzalin
0.86%
N-butyl-N-ethyl-a, a, ex-
tra, fluoro
-2,6-dinitro-p-toluidine
0.86% ^^
oryzalin
0.85%
N-butyl-N-ethyl-a, a, a-
trifluoro
-2,6-dinitro-p-toluidine
0.86%
oryzalin .... 1.00%
orvz
0.85%
N-butyl-N-ethyl-a,a, a-
trifluoro
-2,6-dinitro-p-toluidine
oryzalin
0.67%
o?^|
oryzalin .... 1.00%
oxyf luoren
2.00%
9§T^
oryzalin
1.00%
benefin ... N-butyl-N-ethy] -
a, a, a-
trifluoro-2,6-dinitro-p-
toluidine
l!66% "
solid
961-352
granular
1450-11
granular
7401-413
solid
7401-415
granular
8660-16
granular
8660-139
granular
8660-146
granular
8660-150
granular
32802-30
granular
35512-28
- granular
35512-29
granular
58185-127
granular
62719-108
granular
62719-136
granular
• Table 2 continued
167
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EPA Reg. No.
62719—149
fiO-71 Q_1 KQ
corn q_i 7 A
COT! Q_1 QT
Active Ingredient (s)
0.575%
N-butyl-N-ethyl-a, a, a-
trifluoro-2, 6-dxnitro-p-
toluidine
0.575%
0.75%
60.0%
20.0%
0.8S%
0.29%
Formulation Type
granular
granular
granular
granular
168
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Attachment 5. EPA Acceptance Criteria
169
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SUBDIVISION D
Guideline
Series 61
Series 62
Series 63
Study Title
Product Identity and Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics
171
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61 Product Identify and Composition
ACCEPTANCE CRITERIA
5-
7.
Docs 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 toxicologically significant impurities (e.g., dioxins, nitrosamines) present at <0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
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.
Molecular, structural, and empirical formulas, molecular weight or weight range, and any company
assigned experimental or internal code numbers for each active ingredient.
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.
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 mat 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.
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
toxicologically significant impurities (see #3).
8.
9.
172
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62 Analysis and Certification of Product Ingredients
1.
2.
3."
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?
Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
and all impurities present at > 0.1 %.
Degree or accountability or closure > ca 98 %.
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.].
Complete and detailed description of each step in analytical method used to analyze above samples.
Statement of precision and accuracy of analytical method used to analyze above samples.
Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with
explanation of how the limits were determined.
Upper certified limit.proposed for each impurity present at >_ 0.1 % and for certain lexicologically significant
impurities at < 0.1 % along with explanation of how limiTdetermined.
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.
4.
5.~
6."
8.
9.
173
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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 hi 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 Melting Point
Reported hi °C
Any observed decomposition reported
63-6 BoilingPoint
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 hi g/ml or the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density or registered products may be reported in Ibs/ft or
Ibs/gallon.]
63-8 Solubility
Determined hi distilled water and representative polar and non-polar solvents, including those used hi
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported hi 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° C)
Experimental procedure described
Reported hi mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably
about
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
174
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SUBDIVISION F
Guideline
81-1
81-2
81-3
81-4
81-5
81-6
Study Title
Acute Oral Toxicity in the Rat
Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
Acute Inhalation Toxicity in the Rat
Primary Eye Irritation in the Rabbit
Primary Dermal Irritation Study
Dermal Sensitization in the Guinea Pig
175
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Docs 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.
-------
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.
'• 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 before dosing.
9. Application site at least 10% of body surface area.
1°- Application site covered with a porous nohirritating 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 supplemental and 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.
2.
3.
4.
5.
6.
9."
107
11.
12.
13.
Identify material tested (technical, end-use product, etc).
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 fj.m or less).
At least 5 young adult rats/sex/group.
Dosing, at least 4 hours by inhalation.
Chamber air flow dynamic, at least 10 air changes/hour, at least 19 % oxygen content.
Chamber temperature, 22° C (+2°), relative humidity 40-60%.
Monitor rate of air flow.
Monitor actual concentrations of test material in breathing zone.
Monitor aerodynamic particle size for aerosols.
Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
respirable substance).
Individuajl observations at least once a day.
Observation period to last at least 14 days.
Individual body weights.
14. Gross necropsy on afl animals.
178
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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).
^- _ Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 1 1 .5
3. _ 6 adult rabbits. — —
4- _ Dosing, instillation into the conjunctival sac of one eye
er animal.
mg if a solid' paste or particulate substance-
/. _ Eyes not washed for at least 24hours.
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 supplemental and may not be required for every study.
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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 <2 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 supplemental and may not be required for every study.
180
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81-6 Dermal Semsitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.
2.
4.
S.^
6.'
7."
Identify material tested (technical, end-use product, etc)
- Study not required if material is corrosive or has a
pH of < 2 or >11.5.
One offhe 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.
Complete description of test.
Reference for test.
Test followed essentially as described in reference document
Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
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Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice
183
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Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
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Istmctions for Completing the Confidential Statement of Formula
le Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are
quired. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
If any block is not applicable, mark it N/A.
The CSF must be signed, dated and the telephone number of the responsible party must be provided.
All applicable information which is on the product specific data submission must also be reported on the
CSF.
b.
c.
d.
e.
f.
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h.
i.
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k.
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All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet for
solids.
Flashpoint must be in degrees Fahrenheit and flame extension in inches.
For all active ingredients, the EPA Registration Numbers for the currently registered source products
must be reported under column 12.
The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for the
trade names must be reported.
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 laoel.
All the weights in columns 1-3.a. and 13.b. must be in pounds, kitograms, or grams. In no case will
volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).
All the items under column 13.b. must total 100 percent.
All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form.
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.
When new CSFs are submitted and approved, all previously submitted CSFs become obsolete for that
specific formulation.
189
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?/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 Expire* 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 Xante
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 Flrm(s)
Date of Offer
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
191
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&EPA
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
ter
for
OH* M*. 2070-0107
2070-0057
Explra* 3-31-91
°f '"!ornLalk>n is «*m«* to average 15 minutes per response, including
, searching existing data sources, gather!^ and maintaining the dataVJeeded and
c! colle?ion. *W°™Mon. Send comments regarding the burden estimate or any other
pec t of this i collector i of information, including suggestions for reducing this burden, to Chief, Information Policy
S2J212?' iS;!l!'ir0ir6rtal ******* AS*™* 401 M St., S.W., Washington, DC 20460; and to the Off*
Management and Budget, Paperwork Reduction Project (2070-0106J, Washington. DC 20503.
'lease fill in blanka telow.
s«ny Nam«
troduct Mi
'that:
Compai
EPA R
NO.
For each study cited in support of registration or reregistratton under the Federal Insecticide, Fungicide and
Rodenticide Ad (FIFRA) that is an exclusive use study, I am tho original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
That for each study cttfd In support of registration or reregistratton under FIFRA that is NOT an exclusive use
study. I am tht original data submitter, or I have obtained the written permission of the original data submitter or I
have notified in writing the company(fes) that submitted data I have tiled and have offered to: (a) Pay
compensation for thosa data in accordance with sections 3(c)d)(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. M any. The companies I have notified are: (check one)
companies who have submitted the studies listed on iihe back of this form or attached
—.. or indicated on the attached "Requirements Status and Registrants' Response Form,-
That I have previously complied wtth section 3(c)(l)(D) of FIFRA for trwj studies I have tiled in support of
registration or rtrflg&tratton under FIFRA.
^nature
ini» *n* Till*
ITyp* «r Print)
Date
IERAL OFFSR TO PAY: I hereby offer and agre* to pay compensation to other persons, with regard to the
"^tion or reregistratton of my products, to the extent required by FIFRA sections 3(c)tl){D) and 3(c)(2)(D).
Date
km* and Till* (?!•••• Type or Print)
193
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APPENDIX G. FACT SHEET
195
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United States
Environmental Protection
Prevention, Pesticides
And Toxic Substances
EPA-738-F-9'
September 1
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Regulatory
History
Oryzalin
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 for reregistration case
0186, oryzalin.
Oryzalin is a herbicide that acts by inhibiting cell division in plants. It
is used to control annual grasses, broadleaf weeds, woody shrubs and vines
in grapes, berries and orchard crops, including both fruits and nuts. It also
is used on residential and commercial/industrial lawns and turf, golf course
turf, ornamentals and shade trees., Christmas tree plantations,
fencerows/hedgerows, nonagricultural rights-of-way, and uncultivated areas
including patios, paths, paved areas and power stations. Oryzalin is used
most on turf, almond orchards and grapes. Formulation types include
granular, wettable powder, water dispersible granules, emulsifiable
concentrate, flowable concentrate and liquid.
Oryzalin was first registered in the U.S. as a pre-emergence herbicide
in 1974. EPA issued a Registration Standard for oryzalin in 1987 (NTIS
#PB90-174137), and a Data Call-In notice in 1991. Currently, one
technical product, two formulation intermediates and 35 end-use products
containing oryzalin are registered.
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Human Health
Assessment
Toxicity
In acute toxicity studies using laboratory animals, oryzalin is
practically non-toxic by the oral route and has been placed in Toxicity
Category IV (the lowest of four categories) for this effect. It is of moderate
dermal and inhalation toxicity and causes slight eye irritation, and has been
placed in Toxicity Category III for these effects. No skin sensitization
occurred in tests on guinea pigs.
In subchronic toxicity studies, oryzalin caused the accumulation of an
iron-containing pigment in the kidneys of rats, an increase in the weights of
several organs in mice, and blood, bone marrow and liver effects in beagle
dogs.
Oryzalin is carcinogenic in rats, based on an increase in mammary
gland tumors in females and skin and thyroid tumors in both sexes. It has
been classified as a Group C carcinogen—that is, a possible human
carcinogen for which there is limited animal evidence.
Another chronic toxicity study using beagle dogs showed effects to the
blood, liver, kidneys and thyroid gland. In developmental toxicity studies
using rats, oryzalin caused reduced maternal body weight gain as well as
decreased fetal body weights, an increase in runts and bone development
effects. In rabbits, it caused reduced maternal food consumption and weight
gain, fetal effects and reduced litter size. Reproduction studies using rats
showed increased liver and kidney weights, and decreased food consumption
and body weight gain. Oryzalin was not mutagenic in several studies. A .
dermal irritation study using the oryzalin technical product is required as
confirmatory data.
Dietary Exposure
People may be exposed to residues of oryzalin in the diet when
consuming treated food commodities including almonds, avocados, citrus
fruits, figs, kiwi fruits, olives, pistachios, pome fruits (apples and pears),
pomegranates, small fruits (berries and grapes), stone fruits, tree nuts,
guavas and papayas. Tolerances or maximum residue limits are established
for these commodities (please see 40 CFR 180.304(a) and (b)), have been
reassessed and are acceptable. Tolerances established for several other food
crops will be revoked since no registrations for these uses currently exist.
A new tolerance has been proposed for green coffee beans.
Available data indicate that residues of oryzalin do not concentrate in
processed food or feed; therefore, no food/feed additive tolerances are
established or required. If studies currently underway indicate that residues
do, in fact, concentrate in processed foods, EPA will not be able to set such
tolerances for oryzalin due to the Delaney Clause in Section 409 of the
Federal Food, Drug, and Cosmetic Act (FFDCA), which prohibits the
establishment of food/feed additive tolerances for substances that cause
cancer in test animals or humans.
198
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No international Codex Maximum Residue Levels (MRLs) have been
established or proposed for oryzalin. ,
EPA has assessed the dietary risk posed by oryzalin. For each of the
population groups and subgroups analyzed, chronic dietary exposure is less
than 1/5,000th of the Reference Dose (RfD), an amount believed not to cause
adverse effects if consumed daily over a 70-year lifetime. The dietary
excess cancer risk for the entire U.S. population is estimated to be 8.1 x 10"
7, or 8.1 extra incidences of cancer in 10,000,000. When tolerances for
unregistered commodities are revoked, the upper bound excess cancer risk
estimate will be even lower-.-4.5 x 10"7, or 4.5 extra cancer cases in 10
million.
Occupational and Residential Exposure
Pesticide handlers (mixers, loaders and applicators) may be exposed to
oryzalin during application. EPA conducted a limited exposure/risk
assessment based on available data., examining seven major exposure
scenarios for private and commercial applicators. Low pressure handwand
application was found to have the highest exposure and risk potential. The
private applicator using handwand equipment has an excess risk of 2.6 x 10"
5, or 2.6 extra cancer incidences in 100,000. The commercial applicator
using handwand equipment, who is exposed more frequently, has the
greatest estimated excess cancer risk; that is, 2.6 x 10"4, or 2.6 extra cancer
cases in 10,000. To mitigate these risks, workers will be required to wear
chemical-resistant boots during low pressure handwand application. This
will reduce exposure below the knees, which is significant.
The Worker Protection Standard (WPS) requires workers handling
oryzalin to wear long pants, long sleeved shirts and chemical-resistant
gloves. Because the pesticide is a possible human carcinogen, EPA also is
requiring the use of coveralls and chemical resistant footwear for all uses of
oryzalin (except homeowner uses).
Post-application/reentry exposure also is of concern, and reentry data
are not available to calculate a Restricted Entry Interval (REI). For
agricultural and ornamental crops where reentry exposure is likely, EPA is
requiring an REI of 24 hours instead of 12 hours as imposed by the WPS.
When residential lawns are treated with oryzalin, there is a potential
for continued, substantial contact with treated surfaces, especially among
children. EPA is concerned about these postapplication exposures because
oryzalin is a possible human carcinogen and is persistent. Because of the
lack of turfgrass exposure data, however, the safety of this use cannot be
evaluated. Such exposure data are required by the RED document. Until
they are submitted and evaluated, the residential lawn and turf use of
oryzalin is not eligible for reregistration.
199
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Human Risk Assessment
Oryzalin generally is of moderate acute toxicity, but is carcinogenic in
animal studies and has been classified as a Group C, possible human
carcinogen. Several food crop uses, including grapes and a variety of fruits
and nuts, are registered. However, dietary exposure to oryzalin residues in
foods is extremely low, as is the cancer risk posed by this pesticide to the
general population.
Of greater concern is the risk posed to oryzalin handlers (mixers,
loaders and applicators), and to field workers and others who come into
contact with treated foliage, crops, lawns or turf following application of
this herbicide. Exposure and risk to all applicators will be mitigated by the
use of personal protective equipment (PPE) required by the Worker
Protection Standard (WPS), supplemented by coveralls and chemical-
resistant footwear, as required by this RED.
Post-application reentry workers will be required to observe a 24-hour
Restricted Entry Interval (REI), which is twice as stringent as that set forth
by the WPS. The residential lawn and turfgrass use of oryzalin is not
eligible for reregistration until post-application exposure studies are
submitted to EPA and evaluated.
Environmental
Assessment
Environmental Fate
Parent oryzalin biodegrades slowly with a half-life of approximately
two months. It is not mobile under field conditions and is not volatile.
However, up to 20% of the oryzalin degradates may leach. The registrant
is conducting a study to determine whether degradate leaching is a major
route of dissipation.
Ecological Effects
A preliminary risk screening based on available data indicates that,
from an acute toxicity perspective, oryzalin is moderately toxic to
freshwater fish and invertebrates, and practically riontoxic to birds, small
mammals and honeybees. As would be expected of a herbicide, oryzalin
poses an acute risk to non-target plants, including threatened and endangered
plants.
Ecological Effects Risk Assessment
Minimal risks to birds are posed from acute and dietary exposure to
oryzalin. Chronic risks are not posed at single application rates of 4 pounds
active ingredient per acre (4 Ib ai/A) or less. However, EPA is unable to
determine whether higher application rates pose a serious avian reproduction
threat, and is requiring further studies to complete an assessment of chronic
avian risks.
200
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Additional Data
Required
Product Labeling
Changes Required
Oryzalin does not appear to pose a risk to nonendangered freshwater
fish. However, a Daphnia life-cycle study is needed to determine the
chronic risk to freshwater invertebrates. Acute toxicity studies also are
needed to determine the risks to estuarine and marine organisms.
Oryzalin poses a risk to endangered aquatic species in shallow water
adjacent to treated areas. It also poses a high risk to nontarget plants,
including endangered and threatened plants, from runoff and spray drift.
These risks will be addressed through implementation of the Endangered
Species Protection Program.
Meanwhile, the technical producer of oryzalin has agreed to take
several measures to reduce the pesticide's environmental risks. To mitigate
exposure problems associated with spray drift, airplane and helicopter
applications will no longer be allowed except to agricultural crops in
California. In addition, labeling changes are being required to reflect the
maximum amount of oryzalin that may be applied per year, the maximum
number of applications and the interval between applications.
EPA is requiring the following additional generic studies for oryzalin
to confirm its regulatory assessments and conclusions: Avian Reproduction
(mallard and quail); Acute Toxicity to Estuarine and Marine Organisms
(fish, mollusk and shrimp); Aquatic Invertebrate Lifecycle; Dermal
Irritation; Leaching/Adsorption/Desorption (underway); Spray Drift;.
Storage Stability (apples and grapes, underway); and Processing Studies
(citrus and olives, underway). In addition, Mixer/Loader/Applicator
Exposure Monitoring studies are required for low pressure handwand
application including Estimation of Dermal Exposure at Outdoor Sites and
Estimation of Inhalation Exposure at Outdoor Sites. Reentry Protection
studies are required for use of oryzalin on residential lawns and turf
including: Foliar Dislodgeable Residues; Soil Dislodgeable Residues;
Estimation of Dermal Exposure; and Estimation of Inhalation Exposure.
The same studies (except Soil Dislodgeable Residues) also are required for
Christmas tree and field-grown rose uses of oryzalin.
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSF) and revised labeling for reregistration.
All oryzalin end-use products must comply with EPA's current
pesticide product labeling requirements, and with the following:
Worker Protection Standard (WPS)
POST-APPLICATION REENTRY RESTRICTIONS
o WPS Uses - A 24 hour Restricted Entry Interval (REI) is required for
all oryzalin end-use products registered for uses that are within the scope of
the WPS.
201
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o Non-WPS Uses - The following entry prohibitions are required:
• For Liquids: "Keep all persons, children and pets out of the
treated area until sprays have dried."
• For. Dry Formulations: "Keep all persons, childrena nd pets out of
the treated area until dusts have settled."
• For All Other Non-WPS Formulations including Those for
Residential Use: "Keep all persons, children and pets out of the
treated area until sprays have dried or dusts have settled."
PERSONAL PROTECTIVE EQUIPMENT (PPE) REQUIREMENTS
o WPS Occupational Uses and Non-WPS Uses - The minimum PPE
requirements for pesticide handlers are:
- Coveralls over long-sleeved shirt and long pants;
- Chemical resistant gloves;
- Chemical resistant footwear;
- Chemical resistant headgear for overhead exposures; and
- Chemical resistant apron (mixers and loaders).
o Homeowner Uses - The minimum PPE requirements are:
- Long-sleeved shirt and long pants; and
- Chemical resistant gloves.
WITH ENGINEERING CONTROLS
o When handlers use closed systems, enclosed cabs or aircraft in a
manner consistent with the WPS, the requirements above may be modified
or reduced. See the WPS for specifics.
USER SAFETY STATEMENTS
o Follow manufacturer's instructions for cleaning/ maintaining PPE. If
no such instructions exist for washables, use detergent and hot water. Keep
and wash PPE separately from other laundry.
o Discard clothing and other absorbent materials that have been
drenched or heavily contaminated with this product's concentrate. Do not
reuse them.
o Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.
o Users should remove clothing immediately if pesticide gets inside.
o Users should remove PPE immediately after handling this product.
As soon as possible, wash thoroughly and change into clean clothing. Wash
the outside of gloves before removing.
o For WPS and non-WPS uses, do not apply this product in a way that
will contact workers or other persons, either directly or through drift. Only
protected handlers may be in the area during application.
202
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Regulatory
Conclusion
For More
Information
Precautionary Statement for Fish - To protect fish, all oryzalin end-use
product labels must include the following statement:
"This product is toxic to fish. Do not apply this product directly to
water, or to areas where surface water is present, or to intertidal areas
below the mean high water mark."
Grazing Restrictions - All oryzalin end-use products must include the
following statement:
"Do not graze or feed forage from treated fields or orchards to
livestock."
Changes in Directions for Use - All end-use labels must bear specific
application rates, number of applications per year, total pounds active
ingredient per year, and intervals between applications, as specified in Table
12 of the oryzalin RED document.
Restriction on Aerial Application - All end-use product labels must
prohibit aerial application except for agricultural uses in California.
EPA has determined that products containing oryzalin are eligible for
reregistration except products labeled for use on residential lawns and turf.
The use of eligible oryzalin. products in accordance with labeling
specified in this RED will not pose unreasonable adverse effects to humans
or the environment. These products will be reregistered once the required
confirmatory generic data, product specific data, Confidential Statements of
Formula and revised labeling are received and accepted by EPA. Products
which contain active ingredients in addition to oryzalin will be reregistered
when all of their other active ingredients also are eligible for reregistration.
EPA does not have enough information at this time to make an
eligibility decision for oryzalin products labeled for use on residential lawns
and turf. The Agency is requiring additional data in order to develop a
more complete database regarding these uses of oryzalin.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for oryzalin 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.
Following the comment period, the oryzalin 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 oryzalin RED, or reregistration of individual products containing
oryzalin, please contact the Special Review and Reregistration Division
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(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, from 8:00 am to 6:00 pm Central Time, Monday
through Friday.
«U.S. GOVERNMENT PRINTING OFFICE: 1995-615-003-01085
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