United States Office of Prevention, Pesticides EPA 738-R-94-029
Environmental Protection And foxic Substances September 1994
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Bentazon
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
CERTIFIED MAIL January 27, 1995
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
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 Bentazon. 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 ingredients 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 your reciept 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 Eric Feris at (703) 308-8048 via 1-
800-828-1140.
Sincerely yours,
Louis P. True, Jr., Acting Director
Special Review and
Reregistration Division
Enclosures
-------
-------
SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE" A Product Specific Data Call- In is
enclosed with this RED and must be completed and submitted within 90 days of receipt of this
package. The response consists of a "Data Call-in Response" form and a "Requirements
Status and Registrant's Response" form. Additional generic may also be required to confirm
or support the assessment of the active ingredient. If generic data are required, Generic Data
Call-Ins are being sent only to certain manufacturing use registrants. Generic Data Call-Ins
are not being sent to end use product registrants. However, please note that instructions for
completing the Data Call-Ins, which are incorporated as an Appendix to the RED, may
address both generic and product specific data. If you are an end use registrant, be sure to
follow the instructions for product specific data.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You must
submit the following items for each product within eight months of the date of this letter
(RED issuance 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 to
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; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are 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 Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
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.
-------
REREGISTRATION ELIGIBILITY DECISION
BENTAZON
LIST A
CASE 0182
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
-------
-------
TABLE OF CONTENTS
BENTAZON REREGISTRATION ELIGIBILITY DECISION TEAM i
GLOSSARY OF TERMS AND ABBREVIATIONS iii
GLOSSARY OF TERMS AND ABBREVIATIONS iv
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements 3
D. Regulatory History 4
III. SCIENCE ASSESSMENT 4
A. Physical Chemistry Assessment 4
B. Human Health Assessment 5
1. Toxicology Assessment 5
a. Acute Toxicity 5
b. Subchronic Toxicity 6
c. Chronic Toxicity and Carcinogenicity 6
d. Developmental Toxicity 7
e. Reproductive Toxicity 7
f. Mutagenicity 8
g. Metabolism 8
h. Dermal Penetration 8
i. Reference Dose 8
2. Exposure Assessment 9
a. Dietary Exposure 9
b. Occupational and Residential Exposure 12
3. Risk Assessment 14
a. Dietary 14
b. Occupational and Residential 15
C. Environmental Assessment 16
1. Environmental Fate 16
a. Environmental Chemistry, Fate and Transport 16
b. Environmental Fate Assessment 21
2. Ecological Effects 22
a. Ecological Effects Data 22
-------
b. Ecological Effects Risk Assessment 28
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 42
A. Determination of Eligibility 42
1. Eligibility Decision 42
2. Eligible and Ineligible Uses 43
B. Regulatory Position 43
1. Tolerance Reassessment 43
2. Restricted Use Classification 47
3. Reference Dose 47
4. Cancer Risk Assessment 47
5. Ground Water 47
6. Surface Water 48
7. Spray Drift Advisory 48
8. Chronic Avian Risk 48
9. Rotational Crop Restrictions 48
10. Worker Protection Requirements 48
a. Mixer/Loader/Applicator PPE Requirements 49
b. Early Entry PPE Requirements 49
c. Postapplication Entry Restrictions 50
d. Precautionary Labeling 50
11. Endangered Species Statement 51
V. ACTIONS REQUIRED BY REGISTRANTS 51
A. Manufacturing-Use Products 51
1. Additional Generic Data Requirements 51
2. Labeling Requirements for Manufacturing-Use Products 52
B. End-Use Products 52
1. Additional Product-Specific Data Requirements 52
2. Labeling Requirements for End-Use Products 53
a. Environmental Hazard Statement 53
b. Ground Water Label Advisory 53
c. Worker Protection Requirements 53
d. Reduction in Application Rate 54
e. Labeling for Products Registered for Residential Use Only
54
C. Existing Stocks 54
VI. APPENDICES 56
APPENDIX A. Table of Use Patterns Subject to Reregistration 57
APPENDIX B. Table of the Generic Data Requirements and Studies Used to Make
the Reregistration Decision 69
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of BENTAZON 77
APPENDIX D. List of Available Related Documents 79
-------
APPENDIX E 81
APPENDIX F. Combined Generic and Product Specific Data Call-In 103
Attachment 1. Chemical Status Sheet 121
Attachment 2. Combined Generic and Product Specific Data Call-in
Response Forms Plus Instructions 125
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms and Instructions 135
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 145
Attachment 5. EPA Acceptance Criteria 151
Attachment 6. List of All Registrants Sent This Data Call-In Notice . . 159
Attachment 7. Cost Share Data Compensation Forms, Confidential Statement
of Formula Form and Instructions 163
APPENDIX G. FACT SHEET 169
-------
-------
BENTAZON REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Special Review and Reregistration Division
Eric Feris
Biological and Economic Analysis Division
James Saulmon
Art Grube
Environmental Fate and Effects Division
Laura Dye
James Hetrick
James K. Wolf
Alvaro Yamhure
Health Effects Division
Charles Frick
Alberto Protzel
Paula Deschamp
Laura Morris
Registration Division
Ian Blackwell
Karen Hicks
Policy and Special Projects Staff
Jean Frane
Reregistration Branch
Biological Analysis Branch
Economic Analysis Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Chemical Coordination Branch
Toxicology Branch II
Reregistration Support Chemistry Branch
Occupational and Residential Exposure Branch
Registration Support Branch
Fungicide-Herbicide Branch
Food Safety and Regulation Tracking Section
-------
11
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
ae
a.i.
CAS
CSF
DWEL
EEC
EP
EPA
FDA
FIFRA
FFDCA
GRAS
HA
HDT
LD
50
LD,,
acid equivalent
Active Ingredient
Chemical Abstracts Service
Confidential Statement of Formula
Drinking Water Equivalent Level
Estimated Environmental Concentration. The estimated pesticide concentration in
an environment, such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Generally Recognized As Safe as designated by FDA
Health Advisories
Highest Dose Tested
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
in
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
LEL
LOG
LOEL
jjg/g
MCLG
mg/L
MP
MPI
MOE
MRID
N/A
NPDES
NOEL
OPP
PADI
ppb
ppm
RED
RfD
Lowest Effect Level
Level of Concern
Lowest Observed Effect Level
Micrograms Per Gram
Maximum contaminant Level Goal
milligrams per liter
Manufacturing-Use Product
Maximum Permissible Intake
Margin Of Exposure
Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
Not Applicable
National Pollutant Discharge Elimination System
No Observed Effect Level
Office of Pesticide Programs
Provisional Acceptable Daily Intake
Parts Per Billion
Parts Per Million
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
Reregistration Eligibility Decision
Reference Dose
IV
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The dose at which a substance produces a toxic effect.
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
TRR Total Radioactive Residue
-------
-------
EXECUTIVE SUMMARY
This Reregi strati on Eligibility Decision document (RED) addresses the reregi strati on
eligibility of the pesticide bentazon, 3-isopropyl-lH-2,l,3-benzothiadiazin-4(3H)-one 2,2-dioxide.
The active ingredient in all end-use products is sodium bentazon and in this document, the term
"bentazon" includes the sodium salt.
Bentazon is a selective, contact, early postemergent herbicide that is manufactured by BASF
Corporation and marketed under the trade name Basagran. The products are applied aerially and
on the ground for control of many broadleaf weeds and yellow nut sedge. Bentazon is registered
for use on such terrestrial food and feed crops as alfalfa, beans, corn, peanuts, peas, pepper,
peppermint, rice, sorghum, soybeans and spearmint. In addition, bentazon is registered for use on
two terrestrial nonfood crops: ornamental lawns and turf. Registered formulations of bentazon have
active ingredient concentrations ranging from 6.6 to 53 percent.
A Registration Standard was issued in September, 1985. The Registration Standard
summarized available data supporting the registration of products containing bentazon and required
additional product chemistry, residue chemistry, toxicology, environmental fate, and fish and
wildlife data.
The Agency has now completed its review of the bentazon target data base including data
submitted in response to the Registration Standard and has determined that the uses of bentazon as
currently registered will not cause unreasonable risk to humans or the environment. All currently
registered uses of bentazon are eligible for reregi strati on. The Agency is requiring additional
product chemistry, residue chemistry, toxicology, and environmental fate studies on a confirmatory
basis.
Bentazon has been classified as a "Group E" carcinogen (evidence of non-carcinogenicity
to humans) by the Office of Pesticide Programs (OPP) Peer Review Committee on 6/26/91. The
Agency determined that the RfD for bentazon should be established at 0.03 mg/kg/bwt/day, based
on a No-Observed-Effect-Level (NOEL) of 3.2 mg/kg bwt/day in a one-year dog feeding study and
an uncertainty factor of 100. The theoretical maximum residue concentration (TMRC) for the
overall U.S. population represents 2.2% of the RfD. Based on these risk estimates, chronic dietary
risk from registered uses is not of concern. Tolerances for all uses have been reassessed with
changes noted in Part IV. There are no concerns that warrant the establishment of personal
protective equipment requirements beyond what is required by the Worker Protection Standard
(WPS) or is on current labels for uses not covered by the WPS.
All ecological effect data requirements necessary to complete a risk assessment for the
reregistration of bentazon are fulfilled. However, additional studies (avian reproduction, freshwater
fish toxicity, mollusk toxicity, and aquatic plant growth) are being required on a confirmatory basis.
New avian reproduction studies may help determine risk reduction measures.
VI
-------
Based on the existing data base, the Agency concludes that the use of bentazon as an
herbicide will not pose a serious acute or chronic human toxicity or environmental threat. However,
the Agency does have ground and surface water concerns as well as concerns about chronic effects
to birds. Ground water monitoring data show bentazon detections in ground water in four of eight
states sampled, at concentrations ranging from 0.07 to 120 ppb. The greatest number of detections
have been in California, where 64 wells out of 200 have reported concentrations of bentazon. Since
bentazon is an herbicide, it is anticipated that the risk to non-target terrestrial and semi-aquatic
plants will be high. To address these concerns, the Agency is requiring a ground water label
advisory.
Bentazon is not currently regulated under the Safe Drinking Water Act (SDWA). Therefore
no MCL has been established and water supply systems are not required to sample and analyze for
it. Bentazon currently has a lifetime drinking water health advisory of 20 |ig/L. However, the HA
level will likely be increased to 200 jig/L (200 ppb) because the Office of Pesticide Programs now
has a complete data base which has reduced the uncertainty factor in the reference dose calculation
from 1,000 to 100. Based on the levels in surface waters of other pesticides with characteristics
comparable to bentazon, it is unlikely for the time weighted annual average concentrations of
bentazon to exceed the lifetime HA at one or more surface water source supply systems.
Use limitations to protect endangered plant species may be required but have not yet been
defined. These will be based on recommendations from the Endangered Species Protection Program
which is expected to be completed in 1995.
Before reregistering the products containing bentazon, 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 reregi strati on
only when the other active ingredients are determined to be eligible for reregistration.
vn
-------
I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregi strati on of products with active ingredients registered prior to November 1,
1984. The amended Act provides a schedule for the reregi strati on process to be completed in nine
years. There are five phases to the reregistration process. The first four phases of the process focus
on identification of data requirements to support the reregistration of an active ingredient and the
generation and submission of data to fulfill the requirements. The fifth phase is a review by the U.S.
Environmental Protection Agency (referred to as "the Agency") of all data submitted to support
reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for registration" before calling in data on
products and either reregistering products or taking "other appropriate regulatory action." Thus,
reregistration involves a thorough review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards arising from
the currently registered uses of the pesticide; to determine the need for additional data on health and
environmental effects; and to determine whether the pesticide meets the "no unreasonable adverse
effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of bentazon. The document consists of six sections. Section I is the introduction.
Section II describes bentazon, 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 bentazon. Section V discusses the reregistration
requirements for bentazon. 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.
-------
II. CASE OVERVIEW
A. Chemical Overview
The following active ingredients are covered by this Reregi strati on Eligibility
Document:
• Common Name: bentazon
• Chemical Name: 3-isopropyl-lH-2,l,3-benzothiadiazin-4(3H)-one 2,2-dioxide
• Chemical Family: Based on chemical affinities, bentazon is considered a
member of the thiadiazine group, containing nitrogen and
sulphur hetero atoms.
• CAS Registry Number: 50723-80-3 sodium bentazon
(25057-89-0 bentazon technical)
• OPP Chemical Code: 103901 sodium bentazon
(275200 bentazon technical)
• Empirical Formula: C10H12N2O3S
• Trade and Other Names: Basagran, Twister
• Basic Manufacturer: BASF Corporation
P.O.Box 13528
Research Triangle Park, NC 27709-3528
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 use of bentazon is in Appendix A.
Type of Chemical: herbicide
Mode of Action: benzothiadiazinone contact herbicide, photosynthetic electron
transport inhibitor
Use Groups and Sites:
AQUATIC FOOD CROP
Rice
-------
TERRESTRIAL FOOD CROP
Pepper (chili type)
TERRESTRIAL FOOD + FEED CROP
Beans, beans (dried-type), beans (succulent, lima), beans (succulent, snap), corn, corn
(unspecified), corn (field), corn (pop), corn (sweet), peanuts (unspecified), peas (dried-type), peas
(southern), peas (succulent), peppermint, rice, sorghum, soybeans (unspecified), spearmint
TERRESTRIAL FEED CROP
Alfalfa, corn, sorghum
TERRESTRIAL NONFOOD + OUTDOOR RESIDENTIAL
Ornamental lawns and turf
Pests: arrowhead, balloonvine, beggarticks, bristly starbur, bulrush, Canada thistle,
cocklebur, coffee senna, common groundsel, common purslane, common waterplantain, dayflower,
devilsclaw, ducksalad, galinsoga, gooseweed, hairy nightshade, jimsonweed, kochia, ladysthumb,
lambsquarters, morningglory, marshelder, prickly sida, ragweed, redstem, redweed, sandbur,
sesbania, shepherdspurse, smallflower umbrella sedge, smartweed, spikerush, spurred anoda,
sunflower, tropic croton, velvetleaf, Venice mallow, wild buckwheat, wild mustard, wild poinsettia,
yellow nutsedge
Formulation Types:
Flowable concentrate—19 to 27.6% + 1 other active ingredient (AI)
Soluble concentrate/liquid—29 to 53% + 1 other AI
Methods and Rates of Application:
Flowable concentrate
At postemergence, spray by aircraft or ground equipment at 0.726 to 1.0 Ib
acid equivalent (AE)/acre/yr.
Soluble concentrate/liquid
At postemergence or ratoon, spray by aircraft or ground equipment at 0.5 to
4 Ib AE/acre/yr.
Use Limitations: Do not apply through any type of irrigation system. Do not
discharge effluent containing product into sewage systems or bodies of water. Do not use treated
plants for feed or forage. Do not treat within 30 to 75 days of harvest or 12 to 50 days of grazing.
C. Data Requirements
Data requested in the September 1985 Registration Standard for bentazon included studies
on product chemistry, ecological effects, environmental fate, toxicology, and residue chemistry.
These data were required to support the uses listed in the Registration Standard. Appendix B
-------
includes all data requirements identified by the Agency for currently registered uses needed to
support reregi strati on.
D. Regulatory History
In September 1985, EPA issued a Registration Standard on bentazon. In the Registration
Standard, EPA identified data required to support existing uses of the pesticide and determined
whether existing data were acceptable and sufficient to satisfy the requirement. Under the 1985
Registration Standard, registrants were required to generate data, to supply missing data, and to
replace unacceptable studies.
By 1990, the Agency had reviewed data submitted in response to the 1985 Registration
Standard and reevaluated its position on data needed to support the continued registration of
bentazon products. A Data Call-In notice was issued on August 20, 1990 requiring additional data
on bentazon to address terrestrial and aquatic animal effects, environmental fate, toxicology, residue
chemistry, and plant protection.
This Reregi strati on Eligibility Decision reflects a reassessment of all data which were
submitted in response to the Registration Standard and the Data Call-In.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Bentazon (3-isopropyl-lH-2,l,3-benzothiadiazin-4(3H)-one 2,2-dioxide) is a selective
herbicide used post-emergence on broadleaf weeds and sedges. Bentazon is formulated and used
as the sodium salt alone or in combination with atrazine.
N. /CH
Bentazon
Empirical Formula:
Molecular Weight:
CAS Registry No.:
Shaughnessy No.:
Na
X
.CH
O CH3
Bentazon, sodium salt
C10H12N203S
240.3
50723-80-3
103901 bentazon sodium salt
(275200 bentazon)
-------
Identification of Active Ingredient
Technical grade bentazon is a colorless to white solid with a melting point of 137-139° C
and a vapor pressure of <1 x 10"' mm Hg at 20° C. The solubility (g/100 g solvent, 20° C) of
bentazon is 0.05 in water, 150.7 in acetone, 3.3 in benzene, 18.0 in chloroform, 86.1 in ethanol, 61.6
in ethyl acetate, 0.02 in cyclohexane, and 2.7 in olive oil. The bentazon sodium salt is more soluble
inwater(230g/100g).
Manufacturing-Use Products
There are two registered bentazon sodium salt manufacturing-use products (MPs), BASF
Basagran Manufacturers Concentrate (EPA Reg. No. 7969-42) and BASF Basagran Manufacturers
Concentrate - 600 g/L (EPA Reg. No. 7969-84). Both products are sodium salt formulation
intermediates (FIs) registered to BASF Corporation. The sodium salt FIs are manufactured by an
integrated system. Based on information in Agency records and the Bentazon Reregi strati on
Standard dated 7/26/84, this product is a 46% formulation. Throughout this document the product
will be identified as the 46% FI. The two currently registered BASF MPs are subject to a
reregi strati on eligibility decision.
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base on bentazon is adequate and will support reregi strati on
eligibility.
a. Acute Toxicity
Bentazon has been evaluated for a variety of acute toxicity effects. The results obtained are
summarized in the table below.
Acute Toxicity
Test
Oral LD^n - rat
Dermal LDsn - rat
Eye Irritation - rabbit
Acute Inhalation
Result
1100mg/kg;M&F
>2500 mg/kg
Slight irritation
Data gap
Category
ill
ill
ill
_
-------
Dermal Irritation - rabbit
Dermal Sensitization - guinea pig
Minimal
Sensitizer
III
n/a
* Note: Data pertaining to acute eye irritation, dermal irritation, and dermal sensitization are not required to
support the reregistration of the TGAI. These data are presented for informational purposes.
The acute oral LD50 for technical bentazon from rat studies was 1100 mg/kg (category III
toxicity; Coberly, 1972; Coberly, 1974). The acute oral LD50 in the guinea pig was similar at 1100
mg/kg, category III toxicity, MRID No. 00064316, whereas the acute oral LD50s in rabbits (750
mg/kg; category III toxicity), MRID No. 00135397, and cats (500 mg/kg; category III toxicity),
MRID No. 00135396, were comparable.
The LD50 for technical bentazon in acute dermal studies was over 2500 mg/kg in rats
(category III toxicity; MRID No. 00072789).
The acute inhalation studies available do not meet the present standards; thus, an adequate
acute inhalation study is required.
Bentazon produced mild irritation in the rabbit eye which lasted for about a week (category
in toxicity; MRID No. 00072791). Minimal skin irritation (i.e. reddening) lasting about 72 hours
was produced by bentazon in a primary dermal irritation study in rabbits (category III toxicity;
MRID No. 00072790). Bentazon was reported to produce sensitization of the skin in guinea pigs
(BASF, 1986).
b. Subchronic Toxicity
In a 13-week dietary feeding study in Wistar rats, the doses were 0, 400, 1200, or 3600 ppm
in the diet. The systemic toxicity NOEL was 1200 ppm (equivalent to 60 mg/kg/day). The LOEL
was 3600 ppm (180 mg/kg/day; highest dose tested) based on reductions in body weight gain,
increased thromboplastin and prothrombin times, diuresis, clinical chemistry changes (e.g. increases
in albumin, A/G ratios, and sodium), and increased kidney and liver weights. In addition, females
in the 3600 ppm group showed suggestive evidence for the presence of lung thrombi and dilated
uterine horns (MRID No. 40222201). The available 21-day dermal toxicity study with bentazon
does not meet the present standards; thus, an adequate 21-day dermal toxicity study is required. The
study is considered confirmatory because there does not appear to be a concern for worker risk
based on available information.
c. Chronic Toxicity and Carcinogenicity
Administration of bentazon in the feed of beagle dogs for one year at levels of 0, 100, 400,
or 1600 ppm resulted in a systemic toxicity NOEL of 100 ppm (approximately 3.2 mg/kg/day) and
a LOEL of 400 ppm (approximately 13.1 mg/kg/day). Adverse toxicological effects at the two
higher dose levels consisted of clinical signs of toxicity (emaciation, dehydration, loose and/or
bloody stools, pale mucous membranes, and reduced activity), hematological changes suggestive
6
-------
of anemia (decreased red cells, hemoglobin and hematocrit, abnormal red cell morphology, and
increased reticulocytes, platelets, leukocytes, and partial thromboplastin time), depressed body
weight gains, intestinal inflammation, and congestion of the small intestine and spleen. The anemia
appeared to be due to blood loss from the gastrointestinal tract (MRID No. 41054901).
Fischer 344 rats were given 0, 200, 800, or 4000 ppm bentazon in the diet in a two-year
combined chronic toxicity-carcinogenicity study. The systemic toxicity NOEL was 200 ppm,
equivalent to 10 mg/kg/day (lowest dose tested). Adverse effects were observed at levels of 800
ppm (40 mg/kg/day; LOEL) and 4000 ppm (200 mg/kg/day) and consisted of increases in
prothrombin time and partial thromboplastin time, increases in urine volume, blood urea nitrogen,
and kidney weight along with reduced urinary specific gravity, a reduction in body weight gain, and
a decrease in thyroid gland weight. No compound-related increase in tumors was observed (MRID
No's 00142832, 40871702). B6C3F1 mice were fed 0, 100, 400, or 2000 ppm bentazon in a two-
year combined chronic toxicity-carcinogenicity study. The systemic toxicity NOEL was 100 ppm,
equivalent to 15 mg/kg/day (lowest dose tested). Adverse effects were observed at levels of 400
ppm (60 mg/kg/day; LOEL) and 2000 ppm (300 mg/kg/day). There were an increased prothrombin
time, calcification of the tunica albuginea of the testes, hyperplasia of pancreatic islet cells and liver,
slight increase in mortality, reduced weight gain, areas of hemorrhage in the liver and heart, and
increased weights of the kidney, thyroid gland, and pituitary gland. No compound- related increase
in tumors was observed. (MRTDs 00142832, 40871701)
Bentazon was classified as a "Group E" carcinogen, which denotes evidence of non-
carcinogenicity for humans, by the Agency's Health Effects Division Carcinogenicity Peer Review
Committee, 6/26/91.
d. Developmental Toxicity
In pregnant Wistar rats gavaged with 0, 40, 100, or 250 mg/kg/day of bentazon on gestation
days 6-15, the maternal toxicity NOEL was over 250 mg/kg/day. The developmental toxicity
NOEL was 100 mg/kg/day. The LOEL was 250 mg/kg/day based upon an increase in
postimplantation loss that was characterized by fetal resorptions accompanied by a reduction of
body weights of fetuses surviving to day 21. In addition, there was a reduced rate of ossification
in phalangeal nuclei of fore- and hind-limb digits, sternebrae, and cervical vertebrae (MRID
40114201).
When pregnant Chinchilla rabbits were gavaged with 75, 150, or 375 mg/kg/day, on
gestation days 6-18, the maternal toxicity NOEL was 150 mg/kg/day. The maternal LOEL was 375
mg/kg/day due to the occurrence in a single doe of a partial abortion, embryonic resorptions, and
the absence of living fetuses. The developmental toxicity NOEL was over 375 mg/kg/day (MRID
40114202).
e. Reproductive Toxicity
A reproductive NOEL at 200 ppm (approximately 15 mg/kg/day; lowest dose tested) was
7
-------
found in a two-generation study in Wistar rats. Doses were 0, 200, 800, or 3200 ppm bentazon in
the diet. Higher levels of 800 ppm (reproductive LOEL) and 3200 ppm (approximately 62 and 249
mg/kg/day, respectively) were associated with a decrease in the body weights of the pups during
lactation. For parental toxicity, the NOEL was 800 ppm, and the LOEL was 3200 ppm based on
reductions in food consumption and weight gain, and increased incidence of renal mineralization
and liver microgranuloma (MRID 41054902).
f. Mutagenicity
Bentazon was not mutagenic in the tests for gene mutations, which were reverse mutation
assays in S. typhimurium and in E. coli WP2 uvrA (MRID 00158382) as well as forward mutation
assays with in vitro Chinese hamster ovary cell (HGPRT) cultures (MRID 42129610). Bentazon
was also negative in the mouse micronucleus test for assessing structural chromosomal aberrations
(MRID 00158388) and the unscheduled DNA synthesis assay with primary mouse hepatocyte for
detecting DNA damage (MRID 00158386).
g. Metabolism
The metabolism of [phenyl-U-14C]-bentazon was studied in male and female CD rats. The
labeled compound was administered (a) as a single intravenous dose of 4.1 mg/kg, (b) as a single
oral dose of 3.8 or 205 mg/kg, (c) or as a single oral dose of 3.6 mg/kg following a 14-day
pretreatment with unlabeled bentazon at approximately 4 mg/kg/day. About 88.1-95.9% of the dose
was absorbed from the gastrointestinal tract. Among the orally dosed groups, approximately 88.1-
95.9% of the dose was eliminated in the urine and 0.8-2.3% of the dose was eliminated in the feces
over a period of 168 hours. At sacrifice, total radioactive residue was less than 0.69% of the dose
in all groups. Parent bentazon was the major metabolite found in the urine, amounting to 77.37 -
91.02% of the dose among the orally dosed animals of the main experiment. In addition, 6-OH-
bentazon was present in amounts up to 6.34% of the dose. The isomeric 8-OH-bentazon was present
in trace amounts, up to 0.23% of the dose (MRID 40481801).
h. Dermal Penetration
Single topical applications of radioactive sodium bentazon at doses of 0.12, 1.2, 12.0, or
120.0 mg/kg did not appear to significantly penetrate the skin of rats. Only 1-2% of the
radioactivity was recovered, primarily in the urine. Negligible amounts of applied radioactivity
were retained in the body (MRID 00796942).
i. Reference Dose
The reference dose for bentazon was determined to be 0.03 mg/kg/day based on results of
a one-year feeding study in beagle dogs. The NOEL was 100 ppm (approximately 3.2 mg/kg/day
from measurement of dietary intake). The LOEL (400 ppm or approximately 13.1 mg/kg/day) was
based on hematological changes and bloody stool. An uncertainty factor of 100 was employed. A
value of 0.1 mg/kg/day was established for this chemical by the World Health Organization (WHO)
8
-------
Panel of the Joint Meeting on Pesticide Residues in 1991.
2. Exposure Assessment
a. Dietary Exposure
(1) Plant Metabolism
The qualitative nature of the residue in plants is understood adequately. Studies with a
variety of plants including beans (dry and succulent), corn, soybeans (seeds, forage, and hay), rice
(grain and straw), and wheat indicate that bentazon is absorbed readily from foliage, roots, and
seeds. Translocation throughout rice and wheat plants is extensive; limited translocation in navy
beans and soybeans occurs. Bentazon is metabolized rapidly, conjugated, and incorporated into
natural plant constituents. Metabolism involves the hydroxylation of bentazon at the 6- and 8-
position and subsequent conjugation with carbohydrates or fragmentation and incorporation into
natural constituents such as lignin, proteins, and polysaccharide fractions (starch, pectin,
hemicellulose, and cellulose). The terminal residues of concern are bentazon, 6-hydroxy bentazon,
and 8-hydroxy bentazon.
(2) Animal Metabolism
The qualitative nature of the residue in animals is understood adequately. Studies involving
dairy cows dosed with [U-14C]bentazon, [14C]8-hydroxy bentazon, and [14C]6-hydroxy bentazon at
1 ppm (0.5x), 5 ppm (2.5x), and 20 ppm (lOx) in the diet for a maximum of 28 days demonstrated
that bentazon is absorbed and eliminated rapidly in the urine after oral dosing. Bentazon and 2-
amino-N-isopropyl benzamide (AIBA) accounted for the majority of the terminal residues in tissues
and milk. Studies involving laying hens dosed with [U-14C]bentazon at 100 ppm (2000x) in the diet
for 5 days demonstrated that limited accumulation and metabolism occurs; >80% of the TRR in
tissues and eggs was identified as unchanged bentazon; 16% of the TRR in liver consisted of N-
glucuronide conjugate of bentazon. Dosing at this highly exaggerated rate yielded the highest total
radioactivity (1.632 ppm) in liver. The presence of detectable residues of bentazon in poultry tissues
and eggs from a Ix feeding level is unlikely. The terminal residues to be regulated in animal tissues,
eggs, and milk consist of bentazon and its metabolite AIBA. The current tolerances and tolerance
expression adequately cover these residues in animal commodities.
(3) Residue Analytical Methods - Plants and Animals
Adequate enforcement methods are available for the determination of residues of bentazon
and its 6- and 8-hydroxy metabolites in/on plant commodities and for the determination of bentazon
and AIBA in animal commodities. The Pesticide Analytical Manual (PAM) Vol. II lists Method
II, a GLC method with flame photometric detection for the determination of bentazon and its
hydroxy metabolites in/on corn, rice, and soybeans; the limit of detection for each compound is 0.05
ppm. Method I, a GLC method with nitrogen-specific Coulson conductivity detection, is available
for the determination of residues of bentazon and AIBA in animal tissues, eggs, and milk; the limit
9
-------
of detection for each compound is 0.05 ppm in tissues and eggs and 0.02 ppm in milk. Method III,
modified from Method n, is available for the determination of bentazon and its hydroxy metabolites
in/on peanuts and seed and pod vegetables with a limit of detection of 0.05 ppm for each compound.
Radiolabeled validation of the current tolerance enforcement method (PAM Vol. II, Section
180.355, Method II) by analysis of methanol soluble fractions of soybean forage samples from the
soybean metabolism study indicates that methanol-soluble residues of bentazon and its hydroxy
metabolites are recovered adequately by this method.
Residue data submitted in response to the Guidance Document and in support of petitions
for the establishment of new tolerances were collected using modifications of the available PAM
Vol. II methods. These modified methods, along with the methods listed in PAM Vol. II, are
adequate for bentazon data collection and tolerance enforcement.
The FDA PESTDATA database January 1994 (PAM Vol. I, Appendix II) does not contain
data concerning the applicability of FDA multiresidue methods for recovery of bentazon, and its
hydroxy-metabolites. Data depicting the recovery of bentazon, 6-hydroxy bentazon, and 8-hydroxy
bentazon, through the multiresidue methods remain outstanding.
(4) Storage Stability
Storage stability studies have been conducted using samples of rice grain, rice straw,
snapbean vines, snapbean cannery waste, soybeans, soybean forage, corn forage, peanut forage, flax
seed, flax straw and flax meal. These data indicate that residues of bentazon, 8-OH-bentazon, and
6-OH-bentazon are relatively stable in these matrices for up to two years of frozen storage (-5 to -27
±°C). Thus, by translation, representative storage stability data are available for samples of oil
seeds, non-oily grains, legume vegetables (dried and succulent), and low moisture content
forages/hays stored under conditions and intervals of those samples from residue field trials used
to reassess existing tolerances. Additional storage stability data are needed to validate processing
studies (corn, peanuts, rice, and soybeans) for which data are either lacking or incomplete. Storage
stability data for processed items reflecting up to 14 months of frozen storage are needed to support
these processing studies. These data are considered confirmatory to the existing evidence that
residues of bentazon, 6-OH-bentazon, and 8-OH-bentazon are relatively stable in unprocessed
frozen plant matrices.
No storage stability data for animal commodities are available; these data are outstanding
and are considered confirmatory. Data are required reflecting the storage stability of bentazon and
AIBA in cattle and poultry tissues, milk, and eggs. Storage intervals and conditions must reflect the
existing cattle metabolism/feeding study (MRID 00039849), the existing poultry metabolism/feeding
study (MRID 00039856), and the existing poultry metabolism study (MRID 41089101). Because
available storage stability data for plant commodities indicate that residues are generally stable,
CBRS considers the available information sufficient to support the cattle and poultry
metabolism/feeding studies. The additional data are required to confirm the conclusions that the
existing animal commodity tolerances are adequate.
10
-------
(5) Magnitude of the Residue in Plants
All data submitted in response to reregi strati on requirements pertaining to the magnitude of
the residue in plants have been evaluated and deemed adequate. Field trials typically were
conducted according to the parameters of registered use patterns. The geographical representation
for each commodity is generally adequate and a sufficient number of trials reflecting representative
formulation classes were conducted. The existing 3 ppm tolerances for residues of bentazon in/on
bean forage, pea vine hay, soybean forage, and soybean hay are inadequate to cover the currently
registered use; tolerances of 10 ppm for "beans, vines", 8 ppm for pea vine hay, 8 ppm for soybean
forage, and 8 ppm for soybean hay would be adequate to cover the expected residues resulting from
the currently registered use pattern. The existing 0.05 ppm tolerance for dried peas is inadequate
to cover the currently registered use; a tolerance of 1 ppm would be adequate to cover the expected
residues resulting from the currently registered use pattern.
(6) Magnitude of the Residue in Processed Food/Feed
Processing studies have been conducted on the following RACs: field corn, peanuts, rice
grain, mint, soybeans, and snapbeans (forage/cannery waste). Data on the potential for residue
concentration in grain sorghum processed products have not been required. All data submitted in
response to reregi strati on requirements for magnitude of the residue in processed food/feed have
been evaluated and deemed adequate, pending submission of acceptable storage stability data on
processed food/feed items. Residue concentration was observed in snapbean cannery waste, spent
mint hay, and rice hulls. A 4 ppm feed additive tolerance for residues in spent mint hay has been
established; a feed additive tolerance of 0.25 ppm must be proposed for residues of bentazon in rice
hulls.
(7) Magnitude of the Residue in Meat, Milk, Poultry and Eggs
The ruminant metabolism studies in which lactating dairy cows received [U-14C]bentazon
at 1 ppm (0.25x), 5 ppm (2.5x), and 20 ppm (lOx) in the diet for a maximum of 28 days provide
data to reassess the adequacy of the existing 0.02 ppm tolerance for the combined residues of
bentazon and AIBA in milk and the 0.05 ppm tolerances for the combined residues of bentazon and
AIBA in fat, meat byproducts and meat of cattle, goats, hogs, and sheep. The poultry metabolism
studies in which laying hens received [U-14C]bentazon at 100 ppm (2000x) in the diet for 5 days
provide data to reassess the adequacy of the existing 0.05 ppm tolerances for the combined residues
of bentazon and AIBA in eggs and the fat, meat byproducts and meat of poultry. The storage
stability data to support these studies are outstanding. Because existing data provide evidence
indicative of stability of the residues, the available information is considered adequate to conclude
that the established tolerances on livestock commodities are appropriate.
(8) Confined/Field Rotational Crops
Data pertaining to rotational crop studies are currently under review. A preliminary review
of the data indicates that residues of regulated metabolites in rotated crops are greater than 0.01 ppm
11
-------
at the 40-day plantback interval; thus, limited rotational crop data must be provided. These
conclusions may change upon full review of the data by the Agency.
b. Occupational and Residential Exposure
Mixer/Loader/Applicator (Handler) Exposure: Sodium bentazon is a post-emergent
herbicide that is applied to the foliage of terrestrial food, feed and food, feed, and non-food/outdoor
residential crops/targets. Crops/targets that bentazon may be applied to include: alfalfa, beans
(dried, succulent/lima, and snap), corn (field, pop, sweet), ornamental lawns and turf, peanuts, peas
(dried, southern, and succulent), chili type peppers, peppermint, rice (post emergent and ratoon),
sorghum, soybeans, and spearmint. Applications can be made to all targets, except for ornamental
lawn/turf, using aircraft or typical ground equipment. Applications to ornamental lawn/turf are
limited to ground equipment.
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 1985 Registration Standard. The bentazon toxicity data did not meet the triggers
which were in place at the time the registration standard was issued (i.e., September 1985).
Although chemical-specific mixer/loader/applicator data have not been submitted to EPA, a limited
exposure/risk assessment was conducted for this RED using the Pesticide Handlers Exposure
Database (PHED).
Based on the use patterns described above, two major exposure scenarios were identified,
groundboom and aerial applications. The exposure scenarios are presented in the first table below.
The second table summarizes the caveats and parameters specific to each exposure scenario.
Exposure Values
Exposure Scenario
(Seen. #)
Dermal
Exposure3
(mg/lbai)
Inhalation
Exposure'5
(,ug/lb ai)
Maximum
Label
Application
Rate0
(Ib ai/acre)
Daily
Maximum1'
Treated
Daily
Dermal
Exposure6
(mg/kg/day)
Daily
Inhalation
Exposure6
Cug/kg/day)
Mixer/Loader Exposure
Open Mixing Liquids,
Groundboom Application (l-a)
Open Mixing Liquids, Fixed-Wing
Aerial (l-b)
0.15
0.15
0.4
0.4
2 Ib ai/A
2 Ib ai/A
80 acres
350 acres
0.4 (0.008)*
1 .7 (0.035)*
1.1
4.6
Applicator Exposure
Groundboom Application (II)
Fixed-Wing Aerial (III)
0.02
0.005
1.3
0.2
2 Ib ai/A
2 Ib ai/A
80 acres
350 acres
0.05 (.001)*
0.06 (.001)*
3.5
2.3
Dermal unit exposures are reported as the best fit mean, unless noted. The best fit mean is the composite total dermal
12
-------
exposure based on using the geometric mean for lognormal distributed data, arithmetic mean for normal distributed data, and
the median for all other distribution types.
b Inhalation exposure values are reported as geometric means (lognormal distributions).
0 LUIS Report dated 2/3/93, Bentazon.
d Values represent the maximum area or the maximum volume of spray solution which can be used in a single day to complete
treatments for each exposure scenario of concern.
e Daily Exposure (mg/kg/day) (adjusted for chemical resistant gloves)
= Exposure (mg/lb ai) * Max. Appl. Rate (\b ai/acre) * Max. Treated
60kg
Mixer/Loader Exposure Scenario Descriptions
Exposure
Scenario
(Scen.#^^^^
Data
Source
Clothing
Scenario"
Equipment
Standard
Assumptions'1
(8 hrwork day)
Comments0
Mixer/Loader Exposure
Open Mixing (1)
PHED
Long Pants,
Long-Sleeved
Shirt,
No gloves
Open Mixing
25 gal/acre x 80 acres
(Groundboom)
Acceptable grades;
Dermal = 14 + replicates;
Inhalation = 40 replicates
Applicator Exposure
Groundboom
Application (II)
Aerial (III)
PHED
PHED
Long Pants,
Long-Sleeved
Shirt, No gloves
Long Pants,
Long-Sleeved
Shirt, No Gloves
Open Cab Tractor
All Cab Types
80 acres/day
350 acres/day
Grades A, B, C;
Dermal = 6 + replicates;
Inhalation = 56 replicates.
Inhalation grades A, B, C;
Dermal all grades;
Dermal = 4 to 41 replicates;
Inhalation = 25 replicates.
a Clothing scenario represents actual monitored exposure data. The dermal exposure values on Table 1 have been
adjusted using protection factors to simulate chemical resistant gloves.
b Standard Assumptions based on an 8 hour work day.
0 If dermal and inhalation grades are not listed separately, then the listed grades pertain to both dermal and inhalation.
"Acceptable grades" for meeting Subdivision U Guidelines are grades A and B for dermal and inhalation, and grade C
for hand rinse method.
The Worker Protection Standard (WPS) requires workers handling bentazon to wear long
pants, long sleeved shirts, and chemical resistant gloves. Mixer/loader/applicator exposure estimates
from PHED were used to calculate daily dermal and inhalation exposure for workers handling end-
use products. Exposure scenarios were developed based on the equipment types and practices
specified in the available equipment for a labelled use/instruction (e.g. open cab groundboom tractor
applications on various crops).
13
-------
3. Risk Assessment
a. Dietary
Toxicological Endpoint: The DRES chronic analysis used a Reference Dose (RFD) of 0.03
mg/kg bwt/day, based on a No-Observed-Effect-Level (NOEL) of 3.2 mg/kg bwt/day and an
uncertainty factor of 100. The NOEL was derived from a 1 year feeding study in dogs which
demonstrated hematological changes and bloody stools.
The DRES acute analysis used a NOEL of 100 mg/kg/day which was derived from a
developmental toxicity study in rats, with increased postimplantation loss and reduced body weights
of pups being the effects observed.
Results: Exposure calculated in the DRES chronic analysis was compared to a Reference
Dose (RFD) of 0.03 mg/kg bwt/day. The DRES chronic exposure analysis used tolerance level
residues and a 100 percent crop treated assumption to estimate the Theoretical Maximum Residue
Contribution (TMRC) for the overall U.S. population and 22 population subgroups. These exposure
estimates then were compared to the RfD to estimate chronic dietary risk. The TMRC for the overall
U.S. population from uses supported through reregi strati on is 0.000651 mg/kg bwt/day, which
represents 2.2% of the RfD. The subgroup most highly exposed, non-nursing infants less than one
year old, has a TMRC from supported uses of 0.002444 mg/kg bwt/day, or 8.1% of the RfD. Based
on the risk estimates calculated in this analysis, it appears that chronic dietary risk from the uses
supported through reregi strati on is not of concern.
The DRES detailed acute exposure analysis evaluates individual food consumption as
reported by respondents in the USDA 1977-78 Nationwide Food Consumption Survey (NFCS) and
estimates the distribution of single day exposures through the diet for the U.S. population and
certain subgroups. The analysis reflects consumers only and assumes a uniform distribution of
bentazon in the commodity supply. Since the toxicological effect to which high end exposure is
being compared in this analysis is developmental toxicity, the DRES population group of interest
is "females aged 13 years and above," the DRES subgroup which most closely approximates females
of child bearing age. The Margin of Exposure (MOE) is a measure of how closely the high end
exposure comes to the NOEL (the highest dose at which no effects were observed in the laboratory
test), and is calculated as the ratio of the NOEL to the exposure (NOEL/ Exposure = MOE).
In this analysis, the calculated exposure for the highly exposed individuals in the distribution
(0.2 mg/kg bwt/day) was compared to the NOEL of 100 mg/kg bwt/day from the rat developmental
toxicity study to get an MOE of 500. This means that those persons most highly exposed to
bentazon in their diet would receive 1/500 the dose that represents the NOEL in animals for
developmental toxicity. Acute risk probably is overestimated by this analysis, since it is very
unlikely that tolerance level residues would exist on all of the food items considered in this analysis
and eaten in one day by an individual.
14
-------
b. Occupational and Residential
The Agency has a concern for developmental toxicity based on a toxicity study in the rat
where the NOEL equals 100 mg/kg/day. Because workers may be at risk for toxic effects from
exposure to bentazon, margins of exposure (MOE) are calculated by this equation:
MOE= NOEL (ma/ka/dav)
Exposure (mg/kg/day)
MOE = NOEL/Dermal Exposure with a 2% absorption factor.
Private applicator is defined as a "short term" exposed individual (i.e., one day). A
developmental toxicity NOEL of 100 mg/kg/day is used in the MOE calculation.
Commercial applicator is defined as a "short term" and an "intermediate" exposed individual
(i.e., 10 days). A systemic toxicity NOEL of 60 mg/kg/day is used in the MOE calculation.
Exposure scenarios were developed based on the equipment types and practices specified
in the available labels for each of the various bentazon formulations. All exposure estimates were
completed by considering the most typical equipment for a labelled use/instruction (e.g., open cab
groundboom tractor applications on various crops).
The table below gives the MOEs for the workers exposed for short term and intermediate
term. Based on available information, the MOEs are greater than 100 for exposure scenarios.
Summary Risk Values
Exposure Scenario
(Seen. #)
Daily
Dermal
Exposure6
(mg/kg/day)
Daily
Inhalation
Exposure6
Cwg/kg/day)
Margin of Exposure'
Private
Applicator
Commercial
Applicator
(short term)
Commercial
Applicator
Mixer/Loader Exposure
Open Mixing Liquids,
Groundboom
Application (l-a)
Open Mixing Liquids,
Fixed-Wing Aerial (l-b)
0.4 (0.008)*
1 .7 (0.035)*
1.1
4.6
12500
2857
12500
2857
7500
1714
Applicator Exposure
Groundboom
Application (11)
0.05 (.001)*
3.5 100,000
100,000
60,000
15
-------
1 Fixed-Wing Aerial (III)
0.06 (.001)*
2.3
None
60,000 I
e Daily Exposure (mg/kg/day) (adjusted for chemical resistant gloves)
= Exposure (mg/lb ai) * Max. Appl. Rate (Ib ai/acre) * Max. Treated
60kg
f MOE = NOEL/Dermal Exposure with a 2% absorption factor
* Values in parentheses are dermal exposure values in conjunction with a 2% absorption value
The risk to homeowners who handle bentazon is expected to be lower than the risk to
persons who handle bentazon in their occupation.
C. Environmental Assessment
1. Environmental Fate
At this time, five data requirements in the environmental fate guidelines are not fulfilled for
sodium bentazon salt: aquatic field dissipation (164-2), confined rotational crops (165-1), small-
scale prospective groundwater studies (166-1), droplet size spectrum (201-1), and drift field studies
(202-1). Although these five guidelines are not fulfilled, the Agency has sufficient data for
comprehensive qualitative and quantitative environmental fate, ground- and surface-water
assessments for sodium bentazon salt.
a. Environmental Chemistry, Fate and Transport
(1) Hydrolysis
Parent bentazon was stable to hydrolysis in pH 5, 7, and 9 buffer solutions. The
requirement for hydrolysis data (161-1) has been satisfied. (TRTD 4470236029)
(2) Photodegradation in Water
Phenyl-ring labeled bentazon photodegraded (t1/2 = 63 hours) in pH 7 buffer solution. The
photodegradates were tentatively identified as 3-isopropyl-2,2-dioxo-5-oxo-cyclopentena acid (21%
after 142 hours of irradiation) and 1-[N-(1-methyl- ethyl)]-!-sulfoamino-benzamide (6.46% after
142 hours irradiation), unidentified polar degradates (total of 11.27%), and polar degradates (total
of 8.34%). Photodegradation in water (161-2) is partially satisfied; additional data are required on
identification and quantification of degradates. (MRIDs 41448001, 41432401)
(3) Photodegradation on Soil
Phenyl-ring labeled bentazon was photolytically stable (t1/2 > 941 hours) on loam soil. The
data requirement (161-3) has been satisfied. (TRTD 470236031)
16
-------
(4) Aerobic and Anaerobic Soil Metabolism
Phenyl-ring labeled bentazon, applied at a rate of 20 Ib/A (or 3X application rate), degraded
in mineral soils with a half-life of 24 days in clay loam soil, 31 days in loamy sand soil, and 65 days
in sandy loam soil. Methanol extractable residues in soil were bentazon, n-methyl-bentazon, and
8-chloro-bentazon. Nonlabile residues were extracted from humic, fulvic, and humin fractions of
soil organic matter. Ring-labeled bentazon, applied at a rate of 3 ppm (6 Ibs a.i./A), had a half-life
of 6 weeks in Sandhofen (German) loamy sand soil. Ring-labeled bentazon, applied at rates of 2
to 10 ppm (4 to 20 Ibs a.i./A), had half-lives ranging from < 2 weeks to 14 weeks in Limburgerhoff
(German) loamy sand soil, Bruchfeld (German) sandy clay loam soil, Niedereschbach (German)
loam soil, and Sandhofen (German) loamy sand soil. Most of the methanol extractable bentazon
residues (95%) were found in nonextractable soil fractions (or unavailable) over a 350 day
incubation period. The degradate AIBA was detected at low concentrations (<0.1 ppm). The
degradate AIBA (unknown test substance), applied at a cumulative rate of 1340 ppm (2680 Ibs
a.i./A), had a half-life of 1 to 10 days.
Aerobically aged ring-labeled bentazon residues, applied at rate of 1.7 ppm (3.4 Ibs
bentazon/A), did not rapidly degrade (estimated first-order degradation half-life of 89 days) in
anaerobic, Sandhofen (German) loamy sand soil. The only identifiable degradate was AIBA. This
degradate did not appear to degrade during an 8 week anaerobic incubation period. Soil metabolism
data indicate that bentazon degradation is dependent on oxidative mineralization to CO2 with
subsequent residue incorporation into nonlabile soil organic matter. The aerobic and anaerobic soil
metabolism requirements (162-1 and -2) have been satisfied. (MRIDs 40470502, 00040204,
000400208, 00051659, 00040204, 00040208)
(5) Anaerobic and Aerobic Aquatic Metabolism
Phenyl-labeled bentazon in flooded sandy loam soil and rice clay soil did not degrade under
anaerobic or aerobic conditions. The major route of bentazon dissipation was through incorporation
into nonlabile soil organic matter (20% of applied bentazon after 374 days). Both anaerobic and
aerobic metabolism data requirements (162-3 and -4) have been satisfied. (MRIDs 40470503,
40470504)
(6) Leaching and Adsorption/Desorption
Phenyl-labeled bentazon had low binding affinities in clay sediment (Kd=0.176), clay soils
(Kd=0.422 to 0.384), heavy clay soils (Kd=3.056), and loamy sand (Kd=0.450). However,
Freundlich exponents or soil organic carbon contents were not reported in bentazon equilibrium
studies.
Radiolabeled bentazon, applied at a rate of 1.8 Ibs a.i./A, was quantitatively leached through
30 cm columns of Limburgerhof (German) loamy sand soil and Bruchfeld (German) sandy clay
loam soil. Aged phenyl labeled bentazon soil residues (including N-methyl-bentazon) were retained
at the point of application (66.5% TRR) in loamy sand soil columns. However, parent bentazon was
17
-------
quantitatively eluted (26% TRR) through the soil column. The degradate AIBA was quantitatively
leached through 30 cm column of Limburgerhof (German) loamy sand soil. The mobility data
indicate bentazon and AIBA are very mobile in soil. However, most soil degradates (except AIBA)
of bentazon appear to be relatively immobile in soil. The data requirement (163-1) has been
satisfied. (MRIDs 40470501, 40470505, 00041081)
(7) Terrestrial Field Dissipation
Terrestrial field dissipation studies were considered acceptable from Data Evaluation
Records used to fulfill the 164-1 data requirement in the 1985 Bentazon Registration Standard.
These studies were not rereviewed for the Reregi strati on Eligibility Decision.
Field dissipation studies were conducted in Texas on sandy soil (0.5% OM) planted with
peanuts, Mississippi on a Commerce silt loam soil planted with soybeans and peanuts, Mississippi
on a Sharkey silty clay loam soil planted with soybeans, North Carolina on acidic, sandy loam soil
(2.8% OM) planted to peanuts, Minnesota on clay soil planted to soybeans, and Idaho on a sandy
loam soil. Bentazon, applied as a wettable powder or soluble concentrate at cumulative rates of 1.0
to 10 Ibs a.i./A, had field dissipation half-lives of 7 to 33 days. The degradate AIBA was detected
(< 0.05 ppm) in the North Carolina, Mississippi, Alabama, and Idaho field dissipation studies.
Bentazon and AIBA were not detected in deep soil samples (> 12 inches of soil) in field studies.
The data requirement (164-4) has been satisfied. (MRIDs 00108287, 00108288, 00044400,
00044439, 00106226, 00044404, 00044401, 00044402, 00108296)
(8) Aquatic Field Dissipation
Aquatic field dissipation studies are required to confirm the qualitative aquatic fate and
transport assessments. In addition, this study can be used to determine the need for chronic testing
of aquatic animals. This data requirement (164-2) has not been satisfied.
(9) Confined Crop Accumulation
The submitted confined rotational crop study (MRID 42963701) is adequate to satisfy the
165-1 guideline requirements provided acceptable raw data showing dpm levels in extracts and
analytes are submitted.
Radioactive residues accumulated at levels >0.01 ppm in/on all commodities of chard,
radish, sorghum, turnip, and wheat that were planted 39, 102, 145, 316, and 369 days after [phenyl-
14C]bentazon was applied to sandy soil at 0.5x the maximum seasonal rate under field conditions.
Although the study was conducted at
-------
Combined residues of bentazon and its 6- and 8-hydroxy metabolites were identified at levels
>0.01 ppm in chard (0.02 and 0.04 ppm, 4.8% and 2.5% TRR, respectively) from the 39- and 102-
day rotation, in turnip tops (0.02 ppm, 2.8% TRR) from the 39-day rotation, and in sorghum fodder
(0.01 ppm, 1.2% TRR) from the 39-day rotation; combined residues of concern were <0.01 ppm
in all other commodities at all other rotations.
The data suggest that the rapid uptake and metabolism of bentazon in rotational crops
involves hydroxylation to 6- and 8-hydroxy bentazon, fragmentation, and possibly incorporation
into natural constituents such as polysaccharides, hemicellulose, and cellulose. Metabolism
proceeds similarly in primary crops.
Limited and/or extensive field rotational crop studies are required because the residues of
concern (bentazon, 6-hydroxy bentazon, and 8-hydroxy bentazon) were identified in various
rotational crops at various intervals and were quantified at levels greater than 0.01 ppm in crops
from the 39- and 102-day rotations. Rotational crop restrictions are required on bentazon end-use
product labels. The appropriate plantback intervals will be determined upon submission and review
of the required field rotational crop studies.
(10) Field Crop Rotation
Field rotational crop studies provide supplemental data on accumulation of bentazon residues
in field crops. Bentazon and its major degradate 6 N-methoxy-N-bentazon and 8-methoxy-bentazon
do not appear to accumulate in mature leafy, root, and grain crops planted at emergency, full, and
annual rotation intervals in soils amended with 1 Ib a.i./A with parent bentazon. (MRIDs 41146601,
41146602, 41146603, 41146604, 41146605, 41146606, 41146607,41146608)
(11) Bioaccumulation in Fish
This study is required if significant concentrations of the active ingredient and/or its
principal degradation products are likely to occur in aquatic environments and/or may accumulate
in aquatic organisms.
Bentazon accumulated in the tissues of bluegill sunfish, channel catfish, and crayfish. The
bioconcentration factor (BCF) for 14C-bentazon residues in bluegill sunfish was 0.4 in edible fish
tissue, 2.3 in non-edible fish tissues, and 1.4 in the whole body. Low BCF for bentazon were also
observed in channel catfish. The maximum concentration of 14C-bentazon residues was 11.39 |ig/g
in non-edible tissues, 8.84 |ig/g in whole tissues, and 2.47 |ig/g in edible tissues. First-order
depuration rates of bioaccumulated 14C-bentazon residues were 0.03 d"1 (t1/2=23.1 days; R2=0.49)
in edible fish tissues, 0.05 d"1 (t1/2=13.9 days; R2=0.86) in non-edible fish tissues, and 0.05 d"1
(t1/2=13.9 days; R2=0.87) in whole body fish tissues. Nondepurated radiolabeled bentazon residue
concentrations were 5.29 |ig/g in non-edible fish tissues, 3.39 |ig/g in whole fish, and 1.09 |ig/g in
edible fish tissues. Accumulated residues were identified as N-methyl bentazon and methyl esters
of fatty acids. Radiolabeled bentazon was accumulated in tail meat (<1-10X) and viscera (<1-4X)
in crayfish (Procambrus Clark). This data requirement (165-4) has been satisfied. (MRIDs
19
-------
42236501, 00108300, 40954801, Accession Number 00026408)
(12) Ground and Surface Water Monitoring
Bentazon residues have been detected in the well water in four states: California, Florida,
Missouri, and Virginia. Wells were sampled without detections in Louisiana, Mississippi, Oregon,
and Washington. Bentazon degradates were not considered in any of the well-water monitoring
studies. In the studies, 11% (83 out of 750) of the wells sampled had detections of bentazon
residues, at concentrations ranging from 0.01 to 120 parts per billion (ppb).
The greatest number of detections have been in California, where 64 wells out of 200 have
reported concentrations of bentazon. In California, Bentazon has been reported in 11 counties in
the Pesticides in Ground Water Data Base (PGWDB) (Hoheisel et al., 1992); California
Environmental Protection Agency, Department of Pesticide Regulation (Maes et al., 1992) indicates
that bentazon in well water has been detected in four additional counties. The detections ranged
from 0.01 to 20.0 |ig/L. California reports that the source of bentazon in ground water is the result
of non-point source legal, agricultural use (Maes et al., 1992). Thus in California bentazon residues
have been detected in ground water at the EPA lifetime HA of 20 |ig/L, or less. However, the HA
level will likely be increased to 200 jig/L (200 ppb) because the Office of Pesticide Programs now
has a complete data base which has reduced the uncertainty factor in the reference dose calculation
from 1,000 to 100.
The United States Geological Survey (USGS) and the Florida Department of Environmental
Protection (FDEP) have recently initiated a study (not included in the PGWDB) to evaluate the
influence of municipal reclaimed water on the leaching of pesticides from golf courses in Florida
(USGS, 1994). One of the objectives of the project is to determine if selected pesticides applied to
golf courses in Florida are leached into the shallow ground water. Four shallow wells were sampled
at each of six golf courses studied. The wells were located near greens and tees. Bentazon residues
were detected in 3 of 24 wells. The reported bentazon detections ranged from 3.3 to 120 |ig/L, with
the low value, 3.3 |ig/L, being between the method detection limit and the practical quantification
limit.1
Bentazon residues were detected in 5 of 12 wells (4 household wells and 8 monitoring wells)
located in the 3700 acre Nomini Creek Watershed, Westmoreland County, VA (Hoheisel et al.,
1992). The site was selected as representative watershed in the Virginia coastal plain for monitoring
to document changes in ground-water quality resulting from the implementation of Best
Management Practices. Bentazon concentrations ranged from 0.07 to 0.547 |ig/L. Sources of the
bentazon contamination were not stated.
1 1994 United States Geological Survey Preliminary Data Release: "The Influence of Municipal
Reclaimed Water on the Leaching of Pesticides from Golf Courses in Florida." Swancar, A., USGS Geological
Survey, Tampa, FL. and R. DeHan and D. Vogel, FL Dept. of Environmental Protection, Tallahassee, FL.
20
-------
For the monitoring studies conducted in Missouri, which are summarized in the Pesticides
in Ground Water Data Base (Hoheisel et al., 1992), bentazon was found in five private rural wells
out of 266 (1.9%) located in three agricultural counties. Measured bentazon concentrations ranged
from 0.6 to 1.0 |ig/L. The detection limits of several studies for bentazon ranged from 0.6 to 5.0
|ig/L. With detection limits as high as 5 |ig/L, the potential for bentazon to be present (at levels less
than the detection limit) in water samples, but at levels up to 5 |ig/L, is feasible. Bentazon was not
detected in ground water samples collected in limited studies conducted in four states: Louisiana (3
wells sampled), Mississippi (120 wells), Oregon (44 wells), and Washington (81 wells).
The data requirement (166-1) is not satisfied; small-scale prospective ground-water
monitoring studies are needed to establish the conditions under which bentazon is prone to leach into
ground water under normal agricultural use conditions.
(13) Droplet Size Spectrum and Drift Field
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 bentazon. These spray drift studies are
required for aerially applied herbicides. EPA recognizes the registrant, BASF, is a member of the
Spray Drift Task Force (SDTF) and, therefore, may satisfy the spray data requirements using SDTF
data.
b. Environmental Fate Assessment
Bentazon dissipation is dependent on microbial-mediated degradation, leaching, and surface
water runoff. Bentazon is moderately resistant to degradation (t1/2 = 2 to 14 weeks) in aerobic
mineral soils. Bentazon degradation in aquatic environments appears to be dependent on photolysis.
Bentazon degradation in soil appears to be controlled by oxidative microbial-mediated processes
with subsequent residue incorporation into nonlabile soil organic matter. Bentazon has a low
binding affinity to soil (Kd 0.176 to 3.056) and hence may be expected to leach into ground and to
undergo dissolved runoff to surface waters. Bentazon degradates are N-methyl-bentazon, 8-chloro-
bentazon, and 2-amino-N-isopropylbenazamide (AIBA). The degradate N-methyl-bentazon and 8-
chloro-bentazon are relatively immobile in soil. The degradate AIBA is mobile and nonpersistent
in soil. Terrestrial field studies indicate bentazon dissipates rapidly (t1/2 < 33 days) under typical use
conditions. Leaching did not appear to be a major route of dissipation in field studies.
In the 1985 Registration Standard, it was recognized that bentazon may contaminate surface
waters in use areas through runoff waters; however, bentazon leaching through soil was not
considered a major route of dissipation at that time. The parameters developed in laboratory studies
(such as, soil metabolism and adsorption/desorption studies) are used as predictors of persistent and
mobility. The ranges demonstrated by bentazon for the Kds and soil metabolism half-lives are
similar to those parameters associated with known ground-water contaminants. Also, the EPA
Pesticides in Ground Water Data Base (PGWDB) indicates bentazon was detected in ground water
in Virginia, Missouri, and California. A recent study, not included in the PGWDB, also reported
bentazon in ground water in Florida. Based on available information, EPA concludes that leaching
21
-------
of bentazon through the soil profile is also a major route of dissipation in the environment.
Bentazon exceeds levels of concern (LOG) for ground-water quality. In addition, bentazon
has a high dissolved runoff potential; as a result bentazon may also impact the quality of surface
water. Possible chronic effects of long-term drinking water exposure resulted in the establishment
of a lifetime Health Advisory (HA) of 20 parts per billion (ppb). Concentrations of bentazon at the
HA have been detected in some ground-water wells in California and above the HA in some ground-
water wells in Florida. However, as noted earlier, the HA will likely be increased to 200 ppb.
Small-scale runoff studies indicate that bentazon was found in surface waters. Based on evaluation
of available information, however, bentazon is not expected to exceed the HA in drinking water as
a result of surface water contamination.
Bentazon Degradates. The soil degradates of bentazon were identified as 2-amino-N-
isopropyl benzamide (AIBA) and N-methylbentazon. In laboratory studies, the degradate AIBA
demonstrated high mobility and vulnerability to microbial mediated degradation in soil. Hence it
is considered very mobile but not persistent. The degradate N-methylbentazon demonstrated a lack
of mobility in the column leaching study. There are no data available relating to persistence in the
environment. Based on the available information, it is concluded that these compounds should not
pose a threat to ground-water. AIBA is also considered to have an insignificant impact on surface
water due to its short half-life. Whereas information is not available to conclude that N-
methylbentazon will not have an impact on surface water; however any of the compound getting to
surface water should be adsorbed to sediments.
2. Ecological Effects
a. Ecological Effects Data
The ecotoxicological data base is adequate to characterize the toxicity of sodium bentazon
salt to nontarget terrestrial and aquatic organisms when used on terrestrial food, feed and nonfood
sites.
(1) Terrestrial Data
(a) Avian Acute Toxicity
In order to establish the acute toxicity of sodium bentazon salt to birds, one avian single-dose
oral (LD50) study on one species (preferably mallard or bobwhite quail) is required using the
technical grade material.
Avian Acute Oral Toxicity Findings
Species
% Test
Material
(TGAI)
LD50
Conclusions
22
-------
Bobwhite quail
Mallard duck
94
50
1171 mg/kg
7241 mg/kg
slightly toxic
practically nontoxic
These results show that sodium bentazon is slightly toxic to birds. The guideline
requirement for the avian acute oral LD50 study is fulfilled. (MRIDs 00161296, 00041804)
(b) Avian Subacute Dietary Toxicity
To determine the dietary toxicity to birds exposed to sodium bentazon salt through the diet,
a minimum of two subacute dietary studies (LC50) are required using the technical grade material
and the following test species: one species of waterfowl (preferably the mallard duck) and one
species of upland game bird (preferably bobwhite quail or ring-necked pheasant).
Avian Subacute Dietary Toxicity Findings
Species
Bobwhite Quail
Mallard Duck
% Test
Material
94
42
LC50
>5000 ppm
4830 ppm
Conclusions
practically nontoxic
slightly toxic
On a subacute dietary basis, sodium bentazon salt is slightly toxic to birds. Two studies, one
on the mallard duck and one on the bobwhite quail produced LC50s >4800 ppm. The above studies
indicate a potential "may affect" for endangered avian species. The guideline requirement is
fulfilled. (MRIDs 00161297, 00108850)
(c) Avian Reproduction
Avian reproduction studies are required when birds may be exposed repeatedly or
continuously through persistence, bioaccumulation, or multiple applications, or if mammalian
reproduction tests indicate reproductive hazard. Present product labeling of sodium bentazon salt
allows several applications of the end-use product per growing season.
Avian Reproduction Findings
Species
Bobwhite Quail
% A.I.
97.6
Reproductive
Impairment
Lowest observed
effects = 1 00 ppm
Conclusions
may affect avian reproduction at
dietary residues as low as 100 ppm
23
-------
Mallard Duck
97.6
NOEL = 50 ppm
LOEL = 200 ppm
Two avian reproductive studies, one on the bobwhite quail and one on the mallard duck were
deemed supplemental data. With the bobwhite quail, an unacceptably high control mortality
occurred, and a "no observed effect level" (NOEL) was not obtained. With the mallard duck, the
results indicated that inadequate mixing and uneven distribution of bentazon occurred within the test
diet. Analysis of duplicate samples taken during the study revealed that concentrations varied by
as much as 40 percent. In addition, the stability of bentazon in the diet was not determined.
(MRIDs 42617501, 42651201)
The above avian reproduction tests, however, did provide sufficient information to complete
a preliminary risk assessment. The effects on the avian reproductive cycle, as inferred by the two
supplementary studies, suggest that sodium bentazon salt may affect avian reproduction at dietary
residue levels as low as 100 ppm. Therefore, sodium bentazon salt exceeds the level of concern for
avian chronic effects.
(d) Toxicity to Nontarget Mammals
Wild mammal testing is required on a case-by-case basis, depending on the results of the
lower tier studies such as acute and subacute testing, intended use pattern, and pertinent
environmental fate characteristics.
Mammalian Acute Oral Toxicity Findings
Species
LD50(mg/kg)
Conclusion
Rat (small mammal surrogate, 2 studies)
1480
slightly toxic
The available mammalian data indicate that sodium bentazon salt is slightly toxic to small
mammals on an acute basis. (MRIDs 00092065, 00064314)
(e) Nontarget Insect Toxicity
A honey bee acute contact LD50 study is required if the proposed use is likely to expose
honey bees.
24
-------
Nontarget Insect Acute Contact Toxicity Findings
Species
Apis mellifera
% Test
Material
94
LD50
>100 |jg/bee
Conclusion
practically nontoxic
There is sufficient information to characterize sodium bentazon salt as practically nontoxic
to bees. The guideline requirement is fulfilled. (MRTD 00161305)
(2) Aquatic Data
(a) Freshwater Fish Toxicity
In order to establish the toxicity of a pesticide to freshwater fish, the minimum data required
on the technical grade of the active ingredient are two freshwater fish toxicity studies. One study
should use a coldwater species (preferably the rainbow trout), and the other should use a warmwater
species (preferably the bluegill sunfish).
Freshwater Fish Acute Toxicity Findings
Species
Rainbow trout
(3 studies)
Bluegill sunfish
C? stiirlifis^
% Test Material
(TGAI)
97,48.9,
&4S.9
94, 48.9
LC50
>100 ppm
>100 ppm
Conclusions
practically nontoxic
practically nontoxic
The results of the six 96-hour acute toxicity studies indicate that sodium bentazon salt is
practically nontoxic to both cold and warm water fish. The guideline requirement for acute toxicity
testing of the technical on freshwater fish is fulfilled. (MRIDs 00161299, 00161300, 41922801,
41922802, 00161302, and 42129601)
(b) Freshwater Invertebrate Toxicity
The minimum testing required to assess the hazard of a pesticide is a freshwater aquatic
invertebrate toxicity test, preferably using first instar Daphnia magna or early instar amphipods,
stoneflies, mayflies, or midges.
25
-------
Freshwater Invertebrate Toxicity Findings
Species
Daphnia magna
(2 studies)
% Test
Material
(TGAI)
94, 48.9
LC50
>100 ppm
Conclusions
practically nontoxic
There is sufficient information to characterize sodium bentazon salt as practically nontoxic
to aquatic invertebrates. The guideline requirement is fulfilled. (MRIDs 00161303, 00161304)
(c) Estuarine/Marine Toxicity
Acute toxicity testing with estuarine and marine organisms is required when an end-use
product is intended for direct application to the marine/estuarine environment or is expected to
reach this environment in significant concentrations. The terrestrial nonfood use of sodium
bentazon salt on ornamental lawns and turf may result in exposure to the estuarine environment.
The requirements under this category include a 96-hour LC50 for an estuarine fish, a 96-hour
LC50 for shrimp, and either a 48-hour embryo-larvae study or a 96-hour shell deposition study with
oysters.
Estuarine/Marine Acute Toxicity Findings
Species
Eastern oyster
embryo larvae
Sheepshead minnow
Pink Shrimp
Quahog (clam
embryo larvae)
% Test
Material
(TGAI)
53
94
53
94
LC50
>109 ppm
136 ppm
>132.5 ppm
NOEL = 20 ppm,
ECsn not available
Conclusions
practically nontoxic
practically nontoxic
practically nontoxic
supplemental
There is sufficient information to characterize sodium bentazon salt as practically nontoxic
to oyster embryos and to pink shrimp. The Quahog or clam embryo larvae, Mercenaria, study
(MRID 47029702) was rated supplemental because it failed to determine an EC50 and did not
26
-------
address the mortality effects of the 94 percent active ingredient test material; however, this study
is not essential to meet guideline requirements. (MRIDs 4229935, 42129602)
(3) Non-Target Plants Data
Terrestrial plant testing (seed germination, seedling emergence and vegetative vigor) is
required for herbicides which have terrestrial nonfood/feed or aquatic nonfood (except residential)
use patterns and which have endangered or threatened plant species associated with the site of
application. The above conditions apply for sodium bentazon salt (refer to Section IV.B.4,
Endangered Species).
Aquatic plant testing is required for any herbicide applied to terrestrial nonfood or aquatic
nonfood (except residential) as in the case of sodium bentazon salt. The following species should
be tested: Selenastrum capricornutum, Lemnagibba, Skeletonema costatum, Anabaenaflos-aquae,
and a freshwater diatom.
Tier 1 toxicity data on the technical material for the most sensitive species are listed below:
Nontarget Terrestrial Plant Toxicity Findings
Species
Seed Germination (10 species)
% A.I.
53
EC,
>0.67 Ib a.i./Acre for cabbage
The Tier II toxicity data on the technical material are listed below for the most sensitive test
species:
Nontarget Terrestrial and Aquatic Plant Toxicity Findings
Species
Navicula pelliculosa
Lemna gibba
Selenastrum capricornutum
Seedling emergence &
Vegetative Vigor (1 0
species)
% A.I.
53
53
98
53
ECsn
Invalid
5.35 ppm
4.5 ppm
EC25 = 0.1 1 Ib a.i./A for emergence of lettuce
EC25 = 0.04 Ib a.i./A for vegetative vigor (plant
dry weight) of cabbage
27
-------
The Navicula pelliculosa test (MRID 42129608) was found to be invalid because the
variability in the cell counts precluded determination of valid endpoints. However, a similar aquatic
plant species, Lemna gibba, had a LC50 of 5.3 5 ppm, and Selenastrum capricornutum had the lowest
LC50 at 4.5 ppm of all the aquatic plant species tested. These data suggests a low risk to aquatic
plants. (MRIDs 42129603, 42129604, 42129605, 42129609)
When considering the environmental fate, ecotoxicological data (Tier I and II effects) in
combination with the proposed application methods and rates, The Agency concludes that sodium
bentazon may represent a hazard to true terrestrial and semi-aquatic terrestrial plants (1.3 < RQ <
16). Both Tier I and II data requirements have been satisfied. (MRIDs 42129606, 42129607)
b. Ecological Effects Risk Assessment
(1) Risk to Terrestrial Animals
Nontarget insects will be exposed to sodium bentazon based on the end-use product's
terrestrial food and nonfood use patterns. For nontarget insects, the honeybee or Apis mellifera is
the representative test species; with an acute contact LD50 value of greater than 100 jig/bee, sodium
bentazon salt is practically nontoxic to honeybees. Hence, a low risk to nontarget insects is
anticipated as a result of exposure to sodium bentazon salt.
Avian and mammalian species will be exposed to sodium bentazon through the consumption
of insect and plant food material containing bentazon residues. The criterion for the presumption
of high risk from exposure for acute avian and mammalian species is a value greater than or equal
to 0.5 for the quotient of the estimated environmental concentration (EEC) divided by the lowest
LD50 value for birds and mammals — this is known as the risk quotient (RQ).
Acute RQ = EEC/LC50 > 0.5 for birds and mammals
(a) Avian Acute Oral/Subacute Dietary Effects
Sodium bentazon is expected to be slightly toxic to birds (LD50 of 1171 mg/kg), based on
the acute oral toxicity tests using the bobwhite quail as the representative test species. Moreover,
bentazon is expected to be slightly toxic to birds (LC50 of 4830 ppm), based on the subacute dietary
toxicity tests using the mallard duck as the representative test species. However, minimal risk to
nonendangered and endangered nontarget birds are expected to result from present label uses of
sodium bentazon salt.
Bentazon's maximum single application rate is 2 Ibs a.i./acre. Present product labeling
allows several applications per season. The highest of these multiple rates involves an initial
application of 2 Ibs a.i./acre, followed by another 2 Ibs a.i./acre application, approximately 7 to 10
days later.
Thus, the maximum cumulative application rate for bentazon is 3.6 Ibs a.i./acre (1.6 Ibs
28
-------
a.i./acre + 2 Ibs a.i./acre). Taking into account the degradation/dissipation of residues from the first
treatment, the remaining bentazon is estimated to be 1.6 Ibs a.i./acre when the second application
occurs.
Regarding dietary exposure, terrestrial estimated environmental concentrations (EECs) can
be derived from the use of the Kenega nomograph, an exposure scenario which estimates residues
on a variety of crops and food sources. The maximum concentration of residues of bentazon salt
which may be expected to occur on selected avian or mammalian dietary food items following foliar
application(s) at different application rates is provided in the table below:
Residues on Avian and Mammalian Dietary Food Items in PPM
Use Sites
Range Grasses (short)
Leaves and Leafy
Crops
Forage and Insects
Seeds
Fruits
Application rates (Ib a.i./A)
0.75 1.0 1.5 1.75 2.0 [3.6]*
180 240 360 420 480 820
95 125 185 215 250 450
44 58 87 100 127 210
9 12 18 21 25 44
6 7 11 12 14 26
* Note: The result after two applications, each at a rate of
2 Ibs a.i./acre (assuming a half-life of 24 days and a 7-day
interval between applications).
The highest expected environmental concentration is 820 ppm on short range grasses for the
maximum estimated application rate of 3.6 Ibs of active ingredient per acre (using a Tl/2 value for
24 days). Residues found on dietary food items following bentazon application may be compared
to LC50 values to predict hazard.
The acute avian dietary residue for the mallard duck corrected for 42 percent active
ingredient concentration is the following (concentration of test material referenced in the Dietary
Toxicity Table):
4830X0.42 = 2029 ppm
The risk quotient value would be 820 ppm divided by 2029 ppm (EEC/LC50) or 0.4
indicating high risk to nonendangered birds has not been exceeded, but the risk exceeds the LOG
for endangered birds. The table above indicates that endangered grazing birds, like geese and ducks
may be affected, with risk quotients greater than 0.1.
There are three "goose/duck" endangered species which inhabit the United States along part
29
-------
or all of their ancestral travel routes or "fly ways." The Aleutian Canada goose grazes, but it only
winters in areas where sodium bentazon may be used. During that time, it feeds on grain left from
the previous year. Thus, the potential for exposure to sodium bentazon is negligible. The Hawaiian
goose and the Hawaiian duck do not inhabit areas near any of the use sites for which sodium
bentazon is registered.
However, omnivorous birds, and birds that eat seeds, insects and fruits are unlikely to be
affected with risk quotients less than 0.1. As indicated in the table above the estimated
environmental concentration on seeds, forage and insects ranges from 44 to 210 ppm. Thus the risk
quotient would be the EEC, 210 ppm, divided by the LC50, 5,000 ppm:
RQ = 210 ppm/5,000 ppm = 0.04
Therefore, endangered birds are unlikely to be acutely affected by present label rates and
uses of sodium bentazon.
(b) Avian Chronic Effects
Chronic effects to birds are anticipated based on supplementary avian reproduction studies
and estimated residues on avian food items. Even at the lowest rate of 0.75 Ib of active ingredient
per acre, maximum residues on short grass exceed the LOEL (100 ppm) at which biologically
significant reproductive effects occur. Because a NOEL was not determined, but must be below 100
ppm, there is a risk of chronic effects to birds.
(c) Mammalian Acute Oral and Subacute
Dietary Effects
Sodium bentazon is expected to be slightly toxic to small mammalian species based on the
acute oral toxicity tests using the rat (LD50 of 1480 mg/kg), as a small mammal surrogate. However,
acute oral and subacute dietary risks to nonendangered and endangered nontarget mammals are not
expected to result from present label uses of sodium bentazon salt.
Regarding mammalian dietary toxicity, one day LC50 values were calculated using the
formula below for three representative species: the meadow vole, a herbivore; the adult field mouse,
a granivore; and the least shrew, an insectivore. The formula estimates the dietary LC50 for these
species using a rat acute oral LD50 value of 1480 mg/kg.
LCSO = LDgg mg/kg X Body Weight in grams
Weight Consumed in grams
30
-------
Small Mammal One Day LC50 in PPM
(Based on an LDSO = 1480 mg/kg)
Small Mammal
Meadow vole
Old field mouse
Least shrew
Body
Weight
in
Grams
46 g
13g
5g
%of
Weight
Eaten
Per Day
61 %
16%
110%
Food
Consumed
Per Day in
Grams
28.1 g
2.1 g
5.5 g
Estimated LC50
Per Day in PPM
2423 ppm
9161 ppm
1345 ppm
This table is based on information contained in Principles of Mammology by D. E. Davis
and F. Golly, published by Reinhold Corporation, 1963.
Regarding mammalian dietary risks, the table below indicates the risk quotients for each of
the following application rates:
Mammalian Dietary Risk Quotients
(based on Dietary RQ = EEC/Lowest LC50)
Small Mammal
LC50
Meadow vole
consuming range
grasses
estimated LC50s
(2,423 ppm)
Adult field
mouse
consuming seeds
(9161 ppm)
Least shrew
consuming
forage and
insects
(1 345 ppm)
Application Rates in Ibs. A.
1.5
0.15
0.002
0.065
1.75
0.18
0.0025
0.075
2.0
0.20
0.0027
0.095
./A
[3.6]*
0.34
0.0048
0.155
31
-------
* Note: The result after two applications, each at a rate of
2 Ibs a.i./acre (assuming a half-life of 24 days and a 7-day
interval between applications).
The last column of this table indicates that no hazard would be expected even for small
nonendangered mammals where the EEC on short grass equals 820 ppm, and the risk quotient is
0.34.
However, under certain conditions, the risk quotient for acute effects exceeds the LOG for
endangered mammal species (0.1). But the Agency maintains the conclusion that it is unlikely that
endangered mammals would be adversely affected by the use of sodium bentazon.
The risk quotients for shrews and voles were calculated to be greater than 0.1. However,
further refinement of the risks for these representative species supports the Agency's conclusion that
small endangered insectivores and herbivores are unlikely to be adversely effected by sodium
bentazon salt.
Refined Risk Assessment for Shrews. The typical food item that comprises a shrew's diet
is insects. While in some environmental compartments, it may be appropriate to combine sequential
applications of sodium bentazon, it is probably not appropriate for insects. Because of the following
reasons, only a 2 Ibs a.i./acre application should be used to estimate residues on insects:
• Insects are mobile, such that a second treatment on the same individual insects is unlikely;
and
• sodium bentazon is soluble, and does not bind tightly, therefore, it would likely wash/rub
off any treated insects before the second application occurred.
Residues on insects treated with 2 Ibs a.i./acre would be 127 ppm (see Residue Table). The
LC50/Day for a shrew weighing 5 grams would be 1345 ppm.
1480 mg/kg X5g = 1345 mg/kg = 1345 ppm
5.5 g
The risk quotient, using the estimated LC50 per day for a shrew, is 0.09. This is less than the
endangered mammal LOG of 0.1.
RQ = 127 ppm/1345 ppm = 0.09
Refined Risk Assessment for Voles. The available information suggests that the
endangered Amargosa vole feeds primarily on underground herbaceous items. The Florida Salt
Marsh vole feeds on seeds and succulent plant parts. The original exposure residues were
calculated assuming short grass exposed to direct treatment. Therefore the derived risk quotients
were very conservative and probably are not representative of the actual exposure and potential risk
32
-------
to voles.
It is anticipated that residues on underground herbaceous food items would be very low, and
would not affect endangered voles. If 3.6 Ibs a.i./acre were applied to a 3" layer of soil, the
concentration would be approximately 2.6 ppm. The LC50/Day for a vole weighing 46 grams would
be 2423 ppm.
1480 mg/kg X46g = 2423 mg/kg = 2423 ppm
28.1 g
A case in point, if an Amargosa vole fed all day on underground herbaceous material
contaminated with 2.6 ppm of sodium bentazon, then the risk quotient would be 0.001.
RQ = 2.6 ppm/2423 ppm = 0.001
Residues from a maximum label rate of 3.6 Ibs a.i./acre application on seeds and forage
would range from 44 ppm to 210 ppm. If the Florida Salt Marsh vole fed all day on forage
containing residues of 210 ppm, then the risk quotient would be 0.09.
RQ = 210 ppm 72423 ppm = 0.09
The risk quotients from these exposures are less than 0.1, the LOG for endangered mammals.
(2) Risk to Aquatic Animals
Minimal acute risk to aquatic animals is expected. Moreover, chronic risk to aquatic animals
is not anticipated because of the relatively low exposure values when compared to the acute toxicity
test results.
The following table shows the preliminary estimates of bentazon residues that could occur
in aquatic habitats with different rates of application. The 3.6 Ibs of active ingredient per acre is
considered the highest possible exposure resulting from the two applications, applied approximately
seven day apart, each at rates of 2 Ibs of active ingredient per acre. Five percent of the applied
sodium bentazon is assumed to be transported with surface runoff from a 10 acre field into a 1 acre
shallow water body. Exposure in 6 feet deep water is estimated on the table below.
Estimated Environmental Concentrations for Broadcast Ground
Application in PPM
Application Rate
(Ibs of a.i./acre)
0.25
0.50
6 Foot-Deep Water Body
0.077 ppm
0.015 ppm
33
-------
0.75
1.00
3.60
0.023 ppm
0.031 ppm
0.220 ppm
An aerial or mist blower application of 2 Ibs of active ingredient would contribute a total
pesticide loading of 0.7 Ibs to a one-acre, 6 foot-deep water body (0.6 Ib from runoff and 0.1 Ib from
drift). This total loading of 0.7 Ibs of active ingredient produces a preliminary estimated
environmental concentration of 0.0427 ppm.
Given the same aerial application scenario as stated for 2 Ibs of active ingredient, an
application rate of 3.6 Ibs a.i./acre would result in a preliminary estimated environmental
concentration of 0.077 ppm. This preliminary EEC has been compared to the aquatic animal
endpoints (LC50) obtained experimentally by the registrant to attempt to establish risk levels for the
various groups of aquatic animals.
The table above indicates that at the highest recommended label rate of 3.6 Ibs active
ingredient per acre, the preliminary maximum estimated residue would be about 2.65 ppm which
is far below any of the aquatic animal LC50 s of greater than 100 ppm. Therefore, no hazard to
aquatic animals is anticipated.
(3) Risk to Terrestrial, Semi-Aquatic & Aquatic Plants
The level of concern for terrestrial plants is exceeded by all registered uses of sodium
bentazon salt. The highest risk to terrestrial plants results from runoff to areas containing semi-
aquatic plants after two ground applications, each at 2 Ibs of active ingredient per acre. The next
highest risk is to semi-aquatic plants, resulting from multiple (2) aerial applications.
The following table summarizes the highest risk quotients from various methods of
application and routes of uptake. It assumes two applications of 2 Ibs of active ingredient per acre,
7 days apart.
Risk Quotients for True Terrestrial and Semi-Aquatic Plants
(Two, 2 Ibs of active ingredient/acre Applications)
Method
of
Application
Ground
Aerial
Terrestrial Plant Route of Exposure
Emerging
Seedlings
1.7
2.6
Foliage/Leaves
Minimal
Exposure
4.5
Semi-Aquatic Plant Route of Exposure
Emerging
Seedlings
16
11.5
Foliage/Leaves
Minimal
Exposure
4.5
34
-------
The highest risk quotient of 16 results from runoff to wetlands containing semi-aquatic
terrestrial plants after two ground applications, each at 2 Ibs of active ingredient per acre. The next
highest risk quotient, 11.5, is for semi-aquatic terrestrial plants from two aerial applications.
The LOG for terrestrial and semi-aquatic terrestrial plants is exceeded when the risk quotient
is greater than or equal to 1. All use patterns having two applications each at a rate of 2 Ibs of active
ingredient per acre exceed a level of concern for both true terrestrial and semi-aquatic terrestrial
plants. However, a single ground application does not exceed the level of concern for true terrestrial
plants immediately adjacent to treated sites.
Ground application of 1.5 Ibs of active ingredient per acre on soybeans, however, is not
significantly different than the 2 Ibs of active ingredient per acre application and also exceeds the
level of concern for terrestrial plants.
Two applications at 7-day intervals of 1 Ib of active ingredient per acre would result in the
following risk quotients:
Risk Quotients for True Terrestrial and Semi-Aquatic Terrestrial Plants
(Two Applications of One Ib of active ingredient/Acre)
Method
of
Application
Ground
Aerial
Terrestrial Plant Route of Exposure
Emerging
Seedlings
0.9
1.3
Foliage/Leaves
Minimal
Exposure
2.25
Semi-Aquatic Plant Route of Exposure
Emerging
Seedlings
8
5.75
Foliage/Leaves
Minimal
Exposure
2.25
Any use rate greater than 0.125 Ib a.i./acre would exceed at least one level of concern for
terrestrial plants. The risk quotient for semi-aquatic terrestrial plants receiving runoff from ground
applied sodium bentazon salt at 0.125 a.i./acre would be 1.
Because all uses of sodium bentazon salt at use rates from 1 to 2 Ibs of active ingredient per
acre exceed the level of concern for terrestrial plants, it is expected that the use of sodium bentazon
salt will have significant adverse effects to terrestrial and semi-aquatic plants near treated sites. This
could alter the vegetative community structure or reduce or eliminate populations of ecologically
significant plant species.
(a) Nontarget Terrestrial Plant Effects
Exposure to terrestrial plants may occur through drift and runoff via aerial and ground
application. Two types of habitat containing terrestrial plants are subject to exposure: terrestrial
sites immediately adjacent to treated areas, and semi-aquatic terrestrial sites covered with shallow
35
-------
water or wetlands receiving runoff from treated areas.
Terrestrial plants adjacent to treated areas may take up sodium bentazon salt both through
the soil and through foliage. Soil may be contaminated both from runoff and drift; however,
terrestrial plant foliage would only be exposed from drift. The type of runoff considered to be the
route of exposure for this group of plants is sheet runoff, where the runoff water moves over a
relatively flat ground surface that is not channelized. As it moves over the treated area, it is assumed
to pick up some of the applied sodium bentazon. Then as it moves over adjacent untreated area, it
is assumed, for modeling purposes, to deposit this load of pesticide, thus contaminating the soil.
Only that amount applied to one acre is assumed to be available for transport by this means to an
adjacent 1-acre off-site area containing nontarget terrestrial plants.
Exposure Resulting from a Single Broadcast Ground Application. Based on
preliminary estimates of exposure in off-site soil from a single application, the seedling emergence
level of concern for nontarget terrestrial plants immediately adjacent to treated areas is approached,
but not exceeded, with a risk quotient of 0.9. Runoff is expected to result in exposure to the roots
of nontarget plants adjacent to treated areas. The terrestrial plant seedling emergence EC25 of 0.11
Ib of active ingredient per acre for lettuce is not exceeded by the estimated exposure of 0.1 Ib of
active ingredient per acre from runoff alone. The risk quotient is calculated below.
RQ = 0.1 Ib a. i./acre / 0.11 Ib a. i./acre = 0.9
Exposure Resulting from Two Broadcast Ground Applications. Due to multiple
applications and the relative persistence of sodium bentazon, exposure in off-site soil from runoff
may be higher, resulting in a greater risk quotient. Assuming two applications 7 days apart, the
terrestrial plant seedling emergence level of concern is exceeded with a risk quotient of 1.7. By
assuming a half-life of 20-to-24 days, then the residual from the first application after 7 days will
have declined to about 82 percent of the initial application or 1.7 Ibs of active ingredient per acre.
Adding this to the second application results in an combined application rate of 3.7 Ibs of active
ingredient per acre.
Total Combined Application = 2 Ibs a.i. + 1.7 Ibs a.i.
= 3.7Ibs a.i./acre
The preliminary estimate of exposure from runoff to nontarget terrestrial plant roots from
this combined application is 0.185 Ib of the active ingredient per acre. From this, the risk quotient
is calculated.
RQ = 0.185 / 0.11 = 1.7
Exposure Resulting from a Single Aerial Application. Based on preliminary estimates
of exposure in off-site soil, the seedling emergence level of concern for nontarget terrestrial plants
immediately adjacent to treated areas is exceeded with a risk quotient of 1.45. A combination of
drift and runoff from aerial applications is expected to result in exposure to the roots of nontarget
plants adjacent to treated areas. The seedling emergence EC25 of 0.11 Ib of active ingredient per
acre for lettuce is exceeded by the estimated exposure of 0.16 Ib of active ingredient per acre from
36
-------
runoff and drift combined. The risk quotient is calculated below.
RQ = 0.16/0.11 = 1.45
Exposure Resulting from Two Aerial Applications. Due to multiple applications and the
relative persistence of sodium bentazon, exposure in off-site soil from runoff may be higher,
resulting in a greater risk quotient. By assuming two applications, 7 days apart, the terrestrial plant
seedling emergence level of concern will be exceeded with a risk quotient of 2.6.
In addition, by assuming a half-life of 20-to-24 days, then after 7 days, the residual from the
first aerial application will have declined from 1.2 Ibs of active ingredient per acre2 to about 82
percent of the initial application or 0.984 Ib of active ingredient per acre. Adding this to a second
aerial application of 1.2 Ibs of active ingredient per acre1 results in a combined application rate of
2.184 Ibs of active ingredient per acre available to transport via runoff.
Total combined loading = 1.2 Ibs a.i./acre + 0.984 Ib
a.i./acre = 2.184 Ibs a.i./acre
By assuming 5 percent of the combined loading or 2.184 Ibs of active ingredient per acre
transports via runoff to off-site soil, then resultant exposure will be 0.1092 Ib of active ingredient
per acre.
2.184X0.05 = 0.1092 Ib a.i./acre
Exposure in wetland soil from drift following two aerial applications of bentazon is
estimated to be 0.182 Ib of active ingredient per acre.
0.1 (exposure from 1st drift) X0.823 = 0.082 Ib a.i./acre
The drift exposure remaining from the first spraying is added to the drift exposure from the
second drift episode.
0.1 (exposure from second drift) + 0.082 = 0.182 Ib a.i./acre
Combine the exposure from runoff (based on two applications 7 days apart) with the
exposure from drift to obtain the total exposure in off-site soil; the total exposure is 0.29 Ib of active
ingredient per acre.
0.1092 Ib a.i./acre + 0.182 Ib a.i./acre (drift) = 0.29 Ib a.i./acre
From this, the risk quotient is calculated.
2 With aerial application, it is commonly assumed that only 60% of what is sprayed actually reaches the target site (60% of 2 Ib
a.i./acre is 1.2 Ib a.i./acre).
3 Assumes degradation (half-life 20-24 days) during the 7 days between drift episodes such that only 82% of the exposure from the
first drift episode remains when the second drift reaches the nontarget plants.
37
-------
RQ = 0.29/0.11 = 2.6
Exposure to Nontarget Plant Foliage from a Single Aerial Application. Based on
preliminary estimates of exposure to nontarget plant foliage, the vegetative vigor (cabbage) level
of concern for nontarget terrestrial plants immediately adjacent to treated areas is exceeded with a
risk quotient of 2.5. Assuming 5 percent of the aerially applied sodium bentazon drifts to adjacent
habitat, then the expected exposure will be 0.1 Ib of active ingredient per acre. The vegetative vigor
EC25 of 0.04 Ib of active ingredient per acre is exceeded by this exposure. The risk quotient is
calculated below.
RQ = 0.170.04 Ib a.i./acre = 2.5
Exposure to Nontarget Plant Foliage Resulting from Two Aerial Applications.
Exposure to nontarget plant foliage from drift from a second application is likely to have a greater
adverse effect than from a single application only. Because of the physiology of plants and the fate
of the chemical in the plants, it is not possible to calculate a risk quotient with great confidence,
however. If it is assumed that the exposure from the first drift episode declines to about 82 percent
of the original by the time the second drift episode occurs, then the combined exposure would result
in a risk quotient of 4.5.
The first episode of drift results in exposure of 0.1 Ib of active ingredient per acre as
explained in the discussion of a single application. This would decline to 0.082 Ib of active
ingredient per acre in 7 days assuming a 20-to-24 day half-life. This figure, 0.082 Ib of active
ingredient per acre, is added to 0.1 Ib of active ingredient per acre, which is the estimated exposure
from the second drift episode, to obtain the total combined exposure resulting from two drift
episodes.
0.1 + 0.082 = 0.182 Ib a.i./acre from two drift episodes
From this, the risk quotient for effects to plants from foliar exposure is calculated:
RQ = 0.182/0.04 Ib a.i./acre = 4.55
(b) Nontarget Semi-Aquatic Plant Effects
Semi-aquatic nontarget terrestrial plants may be exposed to sodium bentazon both from
channelized runoff and drift. Channelized runoff may carry bentazon from treated sites, through
channels and ditches, to shallow water and wetlands, and thus contaminating the soil where semi-
aquatic plants occur. Drift from aerial application would contaminate the foliage of these semi-
aquatic nontarget species.
Exposure Resulting from a Single Broadcast Ground Application. Based on preliminary
estimates of exposure in wetland soil where semi-aquatic plants grow, the seedling emergence level
of concern is exceeded through runoff from the treated field based on a risk quotient of 9.
Assuming a drainage basin of 10 acres is treated at 2 Ibs of active ingredient per acre, no soil
incorporation, and relatively high solubility (i.e., 5 percent of applied transports with runoff), the
38
-------
following preliminary exposure concentration is estimated:
2lbX10 acres X 0.05 = 11b a. i./acre
This represents exposure to the roots of semi-aquatic plants. From this, the risk quotient is
calculated.
11b a. i./acre
RQ = = 9
0.11 Ib a. i./acre
Exposure Resulting from Two Broadcast Ground Applications. Based on preliminary
estimates of exposure in wetland soil where semi-aquatic plants grow, the seedling emergence level
of concern is exceeded through runoff from a field treated twice with sodium bentazon salt; the risk
quotient is 16.
Assuming a drainage basin of 10 acres is treated twice, with a 7-day interval between
treatments, of 2 Ibs of active ingredient per acre, no soil incorporation, and relatively high solubility
(i.e., 5 percent of applied transports with runoff), the following preliminary exposure concentration
is estimated:
3.64 Ib X10 acres X0.05 =1.8 Ib a.i./acre
This represents exposure to the roots of semi-aquatic plants. From this, the risk quotient is
calculated.
RQ = 1.8 Ibs a.i./acre/0.11 Ib a.i./acre = 16
Exposure Resulting from a Single Aerial Application. Based on preliminary estimates
of exposure in wetland soil where semi-aquatic plants grow, the seedling emergence level of concern
is exceeded through drift and runoff from a field treated once with sodium bentazon salt; the risk
quotient is 6.4.
If a drainage basin of 10 acres is sprayed by air at 2 Ibs of active ingredient per acre, then
only a portion, approximately 60 percent of the spray will hit the ground.
60% of 2 Ibs a.i. = 1.6 Ibs a.i./acre
The amount available for transport by runoff is 1.6 Ibs of active ingredient per acre.
Assuming high solubility and no soil incorporation, then 5 percent of the active ingredient reaching
the ground could runoff.
1.6 Ibs X 10 acres treatedX 0.05 = 0.8 Ib a.i./acre in the
4 This assumes the active ingredient from the first treatment has degraded on site with a half-life of 20 to 24 days. Approximately 1.6
Ibs of active ingredient or 82% would remain after 7 days. This is added to the second application and the combined amount is assumed
to be available for transport via runoff.
39
-------
wetland
This loading from drift is 5 percent of the 2 Ibs of active ingredient per acre originally
sprayed.
2 Ibs a. i./acre X 0.05 = 0.1 Ib a. i./acre reaching wetlands
The exposure from runoff is added to the exposure from drift because both would be
affecting the plant during the same timeframe. This does not assume both runoff and drift reach the
nontarget plant simultaneously. The physiological response of plants is such that effects from drift
would still be occurring when the exposure to the runoff occurred, that is, they are considered to be
additive even if the exposures were separated by a few days.
0.11b from drift + 0.6 Ib from runoff = 0.7Ib total exposure
or loading
From this, a risk quotient is calculated:
RQ = 0.7/0.11 = 6.4
Exposure Resulting from Two Aerial Applications. Based on preliminary estimates of
exposure in wetland soil where semi-aquatic plants grow, the seedling emergence level of concern
is exceeded through drift and runoff from a field treated twice aerially with sodium bentazon salt;
the risk quotient is 11.5.
Assuming a drainage basin of 10 acres is aerially treated twice, with a 7-day interval between
treatments, of 2 Ibs active ingredient per acre, no soil incorporation, and relatively high solubility
(i.e., 5 percent of applied transports with runoff), then the following preliminary exposure
concentration from runoff is estimated:
3.65 lbsX0.6*X 10 acresX0.05 = 1.08Ibs a.i./acre
* Assumes that only 60% of aerial spray reaches the ground
Exposure in wetland soil from drift following two aerial applications of sodium bentazon
salt is estimated to be 0.182 Ib of active ingredient per acre.
0.1 (exposure from 1st drift or 5% of 2 Ibs a.i.) X 0.826 =
0.082 Ibs a.i./acre
5 This assumes the active ingredient from the first treatment has degraded on site with a half-life of 20 to 24 days. Approximately 1.6
Ibs of active ingredient or 82% would remain after 7 days. This is added to the second application and the combined amount is assumed
to be available for transport via runoff.
6 Assumes degradation (half-life 20-24 days) during the 7 days between drift episodes such that only 82% of the exposure from the
first drift episode remains when the second drift reaches the nontarget plants.
40
-------
The drift exposure remaining from the first spraying is added to the drift exposure from the
second drift episode.
0.1 (exposure from second drift or 5% of 2 Ibs a.i.) + 0.082
= 0.182lbsa.i./acre
The exposure from runoff is added to the drift exposure from both first and second
applications.
0.182 Ib + 1.08 Ibs = 1.262 Ibs a.i./acre is the total loading
This represents total exposure to the roots of semi-aquatic plants from both runoff and drift
resulting after two aerial applications, 7 days apart. From this, the risk quotient is calculated.
RQ = 1.262Ibs a.i./acre/0.11 Ibs a.i./acre = 11.5
Exposure to Semi-Aquatic Plant Foliage Resulting from Two Aerial Applications. The
exposure to foliage of semi-aquatic plants from drift is expected to be essentially the same as to true
terrestrial plant foliage. The vegetative vigor level of concern is exceeded with a risk quotient of
2.5.
(c) Nontarget Aquatic Plant Effects
A preliminary estimated environmental concentration of 0.734 ppm has been calculated for
direct application of 1.0 Ib active ingredient per acre, in a 0.5 feet deep water body which is
considerably lower than the 4.5 ppm LC50 for S. capricornutum. At a maximum application rate of
2.0 Ibs of active ingredient per acre the estimated environmental concentration under similar
conditions would be 1.471 ppm of active ingredient or 0.33 of the S. capricornutum"'s LC50. No
hazard to aquatic plants is expected at the rate of 2.0 Ib active ingredient per acre. Even with two,
two-pound applications seven days apart and assuming no degradation, a 2.9 ppm concentration
(1.471 X 2 = 2.9 ppm) would still not result in risk that exceeds the level of concern. Therefore,
minimal hazard is expected for aquatic plants.
(4) Risk to Endangered Species
Below are the LOCs for endangered plants and animals.
RQ = ££C/LCSO > or = 0.1 for endangered birds
and mammals
RQ = EEC/LCx, >or = 0.05 for endangered aquatic
animals
RQ = EEC/EC25 and the EEC/EC^ > or = 1 for
terrestrial, semi-aquatic and aquatic plants
Acute LOCs were exceeded for endangered birds and mammals based on preliminary EEC
values. By refining the assessment, however, the Agency has concluded that endangered birds and
41
-------
mammals are no longer at risk from present bentazon label rates and usage. But endangered true
terrestrial and semi-aquatic terrestrial plants occurring adjacent to, or receiving runoff from, areas
treated with sodium bentazon may be affected.
The Endangered Species Protection Program is expected to become final in 1994.
Limitations in the use of sodium bentazon salt will be required to protect endangered and threatened
species, but these limitations have not been defined and may be formulation specific. EPA
anticipates that a 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
bentazon as the active ingredient. The Agency has completed its review of these generic data, and
has determined that the data are sufficient to support reregistration of all products containing
bentazon. Appendix B identifies the generic data requirements that the Agency reviewed as part of
its determination of reregistration eligibility of bentazon, 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 bentazon and to determine that bentazon can be used without resulting in
unreasonable adverse effects to humans and the environment provided that the changes specified
in this document are incorporated into product labels. The Agency therefore finds that all products
containing bentazon as the active ingredients are eligible for reregistration. The reregistration of
particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target data base
required for reregistration, the current guidelines for conducting acceptable studies to generate such
data and the data identified in Appendix B. Although the Agency has found that all uses of
bentazon 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 bentazon, if new information comes to the Agency's attention
or if the data requirements for registration (or the guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient bentazon, the Agency has
42
-------
sufficient information on the health effects of bentazon and on its potential for causing adverse
effects in fish and wildlife and the environment. Therefore, the Agency concludes that products
containing bentazon for all uses are eligible for reregi strati on.
The Agency has determined that bentazon products, labeled and used as specified in this
Reregi strati on Eligibility Decision, will not pose unreasonable risks or adverse effects to humans
or the environment.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of bentazon are eligible for reregi strati on.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for bentazon. Where
labeling revisions are imposed, specific language is set forth in Section V of this document.
1. Tolerance Reassessment
Tolerances Listed Under 40 CFR §180.355(a):
The tolerances listed in 40 CFR §180.355(a) are for the combined residues of bentazon and
its 6- and 8-hydroxy metabolites, as shown in Figure A.
Figure A. Chemical structures of bentazon metabolites presently included in the
tolerance expressions.
,NK
H
M CH
^
H0
CH3
6-hydroxy bentazon: 6-hydroxy- 8-hydroxy bentazon: 8-hydroxy- AIBA: 2-amino-A/-isopropyl
3-isopropyl-1H-2,1,3- 3-isopropyl-1H-2,1,3- benzamide
benzothiadizin-4-(3H-)one-2,2- benzothiadizin-4-(3H-)one-2,2-
dioxide dioxide
Sufficient data are available to ascertain the adequacy of the established tolerances listed in
40 CFR §180.355(a) for the following commodities: beans, dried; beans, succulent; beans, hay;
corn, field and pop, grain; corn, field, pop, and sweet, forage; corn, field and pop, fodder; corn,
sweet (K+CWFtR); mint; peanuts; peanuts, hay; peanuts, hulls; peanuts, vines; peas, succulent; peas,
vines; peppers, chili, Bohemian; rice, grain; rice, straw; sorghum, fodder; sorghum, forage; and
sorghum, grain; see Table C for modifications in commodity definitions.
43
-------
The available residue data indicate that the established tolerances for bean vines, dried peas,
pea hay, soybean forage, and soybean hay are too low. Tolerance revisions must be proposed as
follows: (i) from 3 ppm to 10 ppm for bean vines; (ii) from 0.05 ppm to 1 ppm for dried peas; (iii)
from 3 ppm to 8 ppm for pea hay and soybean forage; and (iv) from 0.3 ppm to 8 ppm for soybean
hay. Tolerance revisions have been proposed (PP#9F3782) for dry beans and dried peas (from 0.05
ppm to 1 ppm), bean hay, bean vines, pea hay, pea vines, soybean forage (from 3 ppm to 8 ppm),
and soybean hay (from 0.3 ppm to 8 ppm).
The established tolerance for succulent lima beans should be revoked since residues in/on
lima beans are covered under the tolerance for succulent beans.
The tolerance for Bohemian chili peppers is listed incorrectly as 0.5 ppm in 40 CFR
§180.355(a). The entry should be revised to reflect the correct tolerance of 0.05 ppm.
Bentazon is registered for alfalfa grown for seed. No tolerances are required for alfalfa
grown for seed since label restrictions prohibit the use of the treated plant for sprouting and the use
of any portion of the treated field including forage, hay, seed, or seed screenings for human or
animal feed.
Tolerances Listed Under 40 CFR §180.355(b):
The tolerances listed in 40 CFR §180.355(b) are for food items derived from animals and
are expressed in terms of the combined residues of bentazon and AIBA.
Sufficient data are available to ascertain the adequacy of the established tolerances listed in
40 CFR §180.355(b) for milk and eggs and the fat, meat byproducts, and meat of cattle, goat, hogs,
poultry, and sheep.
Tolerances Listed Under 40 CFR $186.375:
The tolerance listed in 40 CFR §186.375 is for the combined residues of bentazon and its
6- and 8-hydroxy metabolites. Sufficient data are available to ascertain the adequacy of the
established feed additive tolerance listed in 40 CFR §186.375 for mint, hay, spent; see the table
below for the modification in the commodity definition.
A feed additive tolerance must be proposed for the combined residues of bentazon and its
6- and 8-hydroxy metabolites in rice hulls.
Tolerance Reassessment Summary
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Tolerances listed under 40 CFR §180.355
Beans (except soybeans), dried
0.05
0.05
Comment/Correct
Commodity Definition
a)
Beans, dry
44
-------
Commodity
Beans (except, soybeans),
dried, vine hays
Beans (except, soybeans),
forage
Beans, lima (succulent)
Beans, succulent
Bohemian chili peppers
Corn, fodder
Corn, forage
Corn, grain
Corn, fresh (inc. sweet
K+CWHR)
Mint
Peanuts
Peanuts, hay
Peanuts, hulls
Peanuts, forage
Peas (dried)
Peas (dried), vine hays
Peas, forage
Peas, succulent
Rice
Rice, straw
Sorqhum, fodder
Current
Tolerance
(ppm)
3
3
0.05
0.5
0.5
3
3
0.05
0.05
1
0.05
3
0.3
3
0.05
3
3
0.5
0.05
3
0.05
Tolerance
Reassessment
(ppm)
3
10
Revoke
0.5
0.05
3
3
0.05
0.05
1
0.05
3
0.3
3
1
8
3
0.5
0.05
3
0.05
Comment/Correct
Commodity Definition
Beans, hay
Established tolerance is
too low/Beans, vines
Covered under tolerance
for beans, succulent
Tolerance is listed
incorrectly in 40 CFR/
Peppers, chili, Bohemian
Corn, field, fodder and
Corn, pop, fodder
Corn, field, forage;
Corn, pop, forage; and
Corn, sweet, forage
Corn, field, grain; and
Corn, pop, grain
Corn, sweet (K + CWHR)
Peanuts, vines
Established tolerance is
too low/Peas, dried
Established tolerance is
too low/Peas, hay
Peas, vines
Rice, grain
45
-------
Commodity
Sorghum, forage
Sorghum, grain
Soybeans
Soybeans, forage
Soybeans, hay
Current
Tolerance
(ppm)
0.20
0.05
0.05
3
0.3
Tolerance
Reassessment
(ppm)
0.20
0.05
0.05
8
8
Comment/Correct
Commodity Definition
Tolerances listed under 40 CFR §180.355
Cattle, fat
Cattle, mbyp
Cattle, meat
Eggs
Goats, fat
Goats, mbyp
Goats, meat
Hogs, fat
Hogs, mbyp
Hogs, meat
Milk
Poultry, fat
Poultry, mbyp
Poultry, meat
Sheep, fat
Sheep, mbyp
Sheep, meat
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.02
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
0.02
0.05
0.05
0.05
0.05
0.05
0.05
b)
Tolerances listed under 40 CFR §186.375
Spent mint hay
4
4
Mint, hay, spent
Tolerances to be proposed
Rice, hulls
N/A
0.25
46
-------
CODEX HARMONIZATION
No Codex MRLs for bentazon have been established. However, there are bentazon Codex
proposals for several crops at Step 3 of the Codex procedure. The Codex definitions of the residue
for plants and animals are the same as current U.S. definitions. For most of the proposed limits,
there is compatibility with current U.S. tolerances. However, the proposed Codex MRL and U.S
tolerance levels are incompatible for succulent beans and garden peas (Codex, 0.2 ppm; U.S., 0.5
ppm), milk (Codex, 0.05 ppm, the limit of detection; U.S., 0.02 ppm), and rice (Codex, 0.1 ppm;
U.S., 0.05 ppm). If these proposed Codex levels reach the CXL step, compatibility with U.S.
tolerances may be achieved by increasing the U.S tolerances for milk and rice grain to 0.05 and 0.1
ppm, respectively, toxicological considerations permitting, and by reducing the established U.S.
tolerances for succulent beans and peas from 0.5 ppm to 0.2 ppm; the available residue data would
support these tolerance reductions.
2. Restricted Use Classification
Bentazon is not currently classified for restricted use and no change is being required in this
document. However, bentazon may be considered for restricted use for ground water concerns once
the Restricted Use Rule is finalized.
3. Reference Dose
The reference dose for bentazon was determined to be 0.03 mg/kg/day based on results of
a one-year feeding study in beagle dogs. The NOEL was 100 ppm (approximately 3.2 mg/kg/day
from measurement of dietary intake). An uncertainty factor of 100 was employed. Although
bentazon currently has a lifetime drinking water health advisory of 20 |ig/L, the HA level will likely
be increased to 200 jig/L (200 ppb) because the Office of Pesticide Programs now has a complete
data base which has reduced the uncertainty factor in the reference dose calculation from 1,000 to
100.
4. Cancer Risk Assessment
Bentazon was classified as a "Group E" carcinogen, which denotes evidence of non-
carcinogenicity for humans, by the Agency's Health Effects Division Carcinogenicity Peer Review
Committee, 6/26/91.
5. Ground Water
Ground water monitoring data currently available to the EPA show bentazon has been
detected in ground water in four of eight states sampled, at concentrations ranging from 0.07 to 120
ppb. These detections were the result of normal agricultural practices which may include
application to the fields, mixing, loading, and disposal of the pesticide. A small-scale prospective
ground water study must be conducted with bentazon used on soybeans or on turf. A final decision
on the site must be made in consultation with the Agency. Because ground water monitoring studies
have demonstrated that bentazon can leach to ground water in certain vulnerable environments, the
47
-------
Agency requires a ground water label advisory to minimize the effects of bentazon contamination
on ground water quality. See Section V for language. The registrant has also agreed to prepare
educational materials for distributors, dealers, and end users regarding ground and surface water
protection. These materials must be submitted to the Agency for review within one year after the
issuance of this document.
6. Surface Water
No advisory for surface water is being required at this time.
7. Spray Drift Advisory
In order to inform the user of best management practices that would minimize spray drift
from the target site, the Agency is currently preparing spray drift labeling statements. This future
labeling may be required for all bentazon products that may be applied aerially to agricultural crops.
8. Chronic Avian Risk
Chronic effects to birds are anticipated based on supplementary avian reproduction studies
and estimated residues on avian food items. Even at the lowest application rate, maximum residues
on short grass exceed the LOEL (100 ppm) at which biologically significant reproductive effects
occur. Because a NOEL was not determined, but must be below 100 ppm, risk to birds feeding on
food items other than short grass are likely to be impaired. Decreasing the current maximum
application rate to limit the maximum seasonal use rate to 2 Ibs a.i./acre may reduce the potential
for chronic risk to birds, but it would not eliminate this risk. Further, new avian reproduction
studies will be useful to increase certainty of chronic risk to birds and to evaluate risk reduction
measures. The registrant has agreed to lower the maximum seasonal application rate from four to
two pounds per acre.
9. Rotational Crop Restrictions
Rotational crop restrictions are also required on bentazon end-use product labels. The
appropriate plantback intervals will be determined upon submission and review of the required field
rotational crop studies.
10. Worker Protection Requirements
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 9311, "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
48
-------
statements required by PR Notices 93-7 and 93-11 are to be on the product label exactly as
instructed in those notices.
After April 21, 1994, except as otherwise provided in PR Notices 93-7 and 93-11, all
products within the scope of those notices must bear WPS PR Notice complying labeling when they
are distributed or sold by the primary registrant or any supplementally registered distributor.
After October 23, 1995, except as otherwise provided in PR Notices 93-7 and 93-11, all
products within the scope of those notices must bear WPS PR Notice complying labeling when they
are distributed or sold by any person.
a. Mixer/Loader/Applicator PPE Requirements
For each end-use product, Personal Protective Equipment (PPE) requirements for pesticide
handlers will be set during reregi strati on in one of the two ways below.
i) If EPA 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.
ii) If EPA has special concerns about an active ingredient due to
very high acute toxicity or to certain other adverse effects, such as allergic effects, cancer,
developmental toxicity, or reproductive effects:
• 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 no special toxicological concerns about bentazon that warrant the establishment
of active-ingredient-based PPE requirements for handlers.
b. Early Entry PPE Requirements
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 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
49
-------
based on the toxicity concerns about the active ingredient. The requirements are set in one of the
two ways below.
i) If EPA has no special concerns about the acute or other
adverse effects of an active ingredient, it establishes the early-entry PPE requirements based on the
acute dermal toxicity, skin irritation potential, and eye irritation potential of the active ingredient.
ii) If EPA has special concerns about an active ingredient due to
very high acute toxicity or to certain other adverse effects, such as allergic effects, cancer,
developmental toxicity, or reproductive effects, it may establish early-entry PPE requirements that
are more stringent than would be established otherwise.
Since bentazon is classified as category HI for acute dermal toxicity, skin irritation potential
and eye irritation potential and EPA has no special concerns about other adverse effects, the PPE
required for early entry is the minimum early entry PPE permitted under the WPS: coveralls,
chemical-resistant gloves, shoes, and socks.
c. Postapplication Entry Restrictions
Restricted Entry Interval: 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 II, the interim WPS REI is established at 24 hours. If
none of the three acute toxicity effects are in category I or II, the interim WPS REI is established
at 12 hours. A 48-hour REI is increased to 72 hours when an organophosphate pesticide is applied
outdoors in arid areas. In addition, the WPS specifically retains two types of REI's established by
the Agency prior to the promulgation of the WPS: 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 occupational end-use products containing bentazon as an active ingredient,
the Agency is establishing a 12-hour restricted-entry interval established for uses within the scope
of the WPS.
Non-WPS Uses: Label statements prohibiting use until sprays have dried are required for
occupational uses outside the scope of the WPS and for homeowner uses. See part V.
d. Precautionary Labeling
Because bentazon is a skin sensitizer, the Agency is requiring a precautionary statement on
all end-use products. See part V.
50
-------
11. Endangered Species Statement
The Agency has concerns about the exposure of threatened and endangered plant and animal
species to bentazon. Endangered terrestrial plants occurring adjacent to, or receiving runoff from,
areas treated with bentazon may be affected.
Currently, the Agency is developing a program ("The Endangered Species Protection
Program") to identify all pesticides whose use may cause adverse impacts on endangered and
threatened species and to implement mitigation measures that will eliminate the adverse impacts.
The program would require use modifications or a generic product label statement, requiring users
to consult county-specific bulletins. These bulletins would 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.
The Agency plans to publish a description of the Endangered Species Program in the Federal
Register and by 1995 have enforceable county-specific bulletins available. Because the Agency is
taking this approach for protecting endangered and threatened species, it is not imposing label
modifications at this time through the RED. Rather, any requirements for product use modifications
will occur in the future under the Endangered Species Protection Program.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregi strati on of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of bentazon for all uses has been
reviewed and determined to be substantially complete. However, confirmatory data in the areas of
environmental fate, ecological effects, toxicology, product chemistry, and residue chemistry are
required, as discussed previously in this document and as specified in the Data Call-In Notice
appended to this document.
The available 21-day dermal toxicity study with bentazon does not meet the present
standards; thus, an adequate 21-day dermal toxicity study is required. The study is considered
confirmatory because there does not appear to be a concern for worker risk based on available
information.
Aquatic field dissipation studies (guideline 164-2) are required to confirm the qualitative
aquatic fate and transport assessments under typical use conditions. In addition, this study can be
used to determine the need for chronic testing of aquatic animals. If this study indicates extremely
long persistence in aquatic habitats, then requesting the submission of chronic studies would have
51
-------
added value.
Field rotational crop studies (guideline 165-2) are required because the residues of concern
(bentazon, 6-hydroxy bentazon, and 8-hydroxy bentazon) were identified in various rotational crops
at various intervals and were quantified at levels greater than 0.01 ppm in crops from the 39- and
102-day rotations. Rotational crop restrictions are required on bentazon end-use product labels. The
appropriate plantback intervals will be determined upon submission and review of the required field
rotational crop studies.
A small-scale prospective ground water study (guideline 166-1) is needed to establish the
conditions under which bentazon is prone to leach into groundwater. Ground water monitoring data
currently available to EPA show that bentazon has been detected in ground water in four of eight
states sampled, at concentrations ranging from 0.07 to 120 ppb. A small-scale prospective ground
water study must be conducted with bentazon covering its use in soybeans or turf following
consultation with the Agency.
Because bentazon is a herbicide and could be phytotoxic to nontarget plants, spray drift
studies (Droplet Size Spectrum, guideline 201-1, and Drift Field Evaluation, guideline 202-1) are
needed to assess off-target aerial movement of bentazon. The Agency recognizes the registrant,
BASF, is a member of the Spray Drift Task Force (SDTF) and may, therefore, choose to satisfy the
spray drift data requirements using SDTF data.
All ecological effect data requirements necessary to complete a risk assessment for the
reregi strati on of bentazon are fulfilled. However, fish toxicity, mollusk toxicity, and avian
reproduction studies would provide added value in increasing the certainty of the risk assessment.
2. Labeling Requirements for Manufacturing-Use Products
No additional requirements are being imposed by this RED for Manufacturing-Use products.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. The product specific data
requirements are listed in Appendix G, the Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet current EPA
acceptance criteria (Appendix F; Attachment E) and if not, commit to conduct new studies. If a
registrant believes that previously submitted data meet current testing standards, then study MRID
numbers should be cited according to the instructions in the Requirement Status and Registrants
Response Form provided for each product.
52
-------
2. Labeling Requirements for End-Use Products
The following statements, some of which may currently be on some product labels, are now
required on all labels as specified below.
a. Environmental Hazard Statement
Environmental Hazard Statements for crayfish and catfish commercial farms are required
for non-residential end-use product labeling. Environmental hazard requires the following labeling
statement:
"For terrestrial uses only, do not apply directly to water, or to areas where surface water is present
or to intertidal areas below the mean high water mark. Do contaminate water when disposing of
equipment washwater or rinsate. "
b. Ground Water Label Advisory
The Agency is requiring a ground-water label advisory to minimize the effects of bentazon
contamination on ground-water quality. The label advisory must state:
"This chemical is known to leach through soil into groundwater under certain conditions as a result
of agricultural use. Use of this chemical in areas where soils are permeable, particularly where the
water table is shallow, may result in groundwater contamination."
c. Worker Protection Requirements
i) The Agency is establishing the following entry
restriction for all non-WPS occupational uses of bentazon products:
"Do not enter or allow others to enter the treated area until sprays have dried."
ii) The Agency is establishing the following entry
restrictions for all homeowner-use products:
"Do not allow persons or pets to enter the treated area until sprays have dried."
iii) The Agency is requiring the following label statements
for all bentazon products intended primarily for occupational uses. This includes uses both within
the scope and not in the scope of the WPS.
Application Restrictions:
"Do not apply this product in a way that will contact workers or other persons, either directly or
through drift. Only protected handlers may be in the area during application."
53
-------
Engineering Controls:
"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 Requirements:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If there are no such instructions
for washables, use detergent and hot water. Keep and wash PPE separately from other laundry. "
User Safety Recommendations:
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet. "
"Users should remove clothing immediately if pesticide gets inside. Then wash thoroughly and put
on clean clothing."
"Users should remove PPE immediately after handling this product. Wash the outside of gloves
before removing. As soon as possible, wash thoroughly and change into clean clothing."
iv) In addition, because bentazon is classified as a skin
sensitizer, the Agency requires the following statement to be placed in the "Hazards to Humans (and
Domestic Animals)" section of the Precautionary Statements on the labeling of all end-use products
containing bentazon:
"This product may cause skin sensitization reactions in some people."
d. Reduction in Application Rate
All bentazon labels must be amended to reflect a maximum seasonal application rate of 2
Ibs ai/a.
e. Labeling for Products Registered for Residential Use Only
The Agency is requiring the following label statement for all bentazon products intended for
use on lawns and turf:
"Do not apply directly to water. Do not contaminate water when disposing of equipment washwater
or rinsate."
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26
54
-------
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.
55
-------
-------
VI. APPENDICES
-------
APPENDIX A. Table of Use Patterns Subject to
Reregistration
57
-------
-------
Date 08/03/94 ) Time 14:44
44444444444444444444444444444
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
))))))))
ALFALFA
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
BEANS
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
BEANS, DRIED-TYPE
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
BEANS, SUCCULENT (LIMA)
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
BEANS, SUCCULENT (SNAP)
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
APPENDIX A ) CASE 0182, [Bentazon] Chemical 103901 [Bentazon]
LUIS 1.5 ) Page 1
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) Dose cycle /crop /year [day(s)]
cycle
Use Group: TERRESTRIAL
SC/L NA
SC/L NA
1 Ib (AE) A * NS
1 Ib (AE) A * NS
NS
NS
Use Group: TERRESTRIAL
SC/L NA
SC/L NA
1 Ib (AE) A * NS
1 Ib (AE) A * NS
NS
NS
Use Group: TERRESTRIAL
SC/L NA
SC/L NA
SC/L NA
SC/L NA
1 Ib (AE) A * NS
UC * NS
1 Ib (AE) A * NS
UC * NS
NS
NS
NS
NS
Use Group: TERRESTRIAL
SC/L NA
SC/L NA
SC/L NA
SC/L NA
1 Ib (AE) A * NS
UC * NS
1 Ib (AE) A * NS
UC * NS
NS
NS
NS
NS
Use Group: TERRESTRIAL
SC/L NA
SC/L NA
SC/L NA
1 Ib (AE) A * NS
UC * NS
1 Ib (AE) A * NS
NS
NS
NS
PEED CROP
2 Ib
(AE)
2 Ib
(AE)
POOD+PEED
NS
NS
POOD+PEED
2 Ib
(AE)
UC
2 Ib
(AE)
UC
POOD+PEED
2 Ib
(AE)
UC
2 Ib
(AE)
UC
POOD+PEED
2 Ib
(AE)
UC
2 Ib
(AE)
NS NS 2 WA
NS NS 2 WA
CROP
2 Ib NS 2 , , , ,
(AE)
2 Ib NS 2 , , , ,
(AE)
CROP
NS NS 2 , , , ,
NS NS NS
NS NS 2 , , , ,
NS NS NS
CROP
NS NS 2 , , , ,
NS NS NS
NS NS 2 , , , ,
NS NS NS
CROP
NS NS 2
NS NS NS
NS NS 2
C14, C46, G99
C14, C46, G99
C20, C46, HOI (30)
C20, C46, HOI (30)
C20, C46, HOI (30)
C46, HOI (30)
C20, C46, HOI (30)
C46, HOI (30)
C20, C46, HOI (30)
C46, HOI (30)
C20, C46, HOI (30)
C46, HOI (30)
C20, C46, HOI (30)
C46, HOI (30)
C20, C46, HOI (30)
59
-------
Date 08/03/94 ) Time 14:44
APPENDIX A ) CASE 0182, [Bentazon] Chemical 103901 [Bentazon]
LUIS 1.5 ) Page
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
)))))))))))))))))))))))
BEANS, SUCCULENT (SNAP) (con't)
CORN
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
CORN (UNSPECIFIED)
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
SC/L NA
SC/L NA
Use Group: TERRESTRIAL FOOD+FEED CROP (con't)
UC * NS NS UC NS NS
Use Group: TERRESTRIAL FEED CROP
C46, HOI(30)
F1C NA
SC/L NA
F1C NA
SC/L NA
.726 Ib (AE) A *
1 Ib (AE) A *
.726 Ib (AE) A *
1 Ib (AE) A *
1
NS
1
NS
NS
NS
NS
NS
Use Group: TERRESTRIAL
F1C NA
F1C NA
F1C NA
F1C NA
SC/L NA
SC/L NA
F1C NA
F1C NA
SC/L NA
UC *
UC *
Use Group
.726 Ib (AE) A *
UC *
1 Ib (AE) A *
UC *
.726 Ib (AE) A *
UC *
1 Ib (AE) A *
NS
NS
1/1 yr
1/1 yr
: TERRESTRIAL
1
NS
NS
NS
1
NS
NS
NS
1/1 yr
NS
NS
NS
1/1 yr
NS
NS
2 Ib
(AE)
NS
2 Ib
(AE)
FOOD+FEED
NS
NS
FOOD+FEED
NS
NS
2 Ib
(AE)
UC
NS
NS
2 Ib
(AE)
NS NS 2
NS NS 2
NS NS 2
NS NS 2
CROP
NS NS NS
NS NS NS
CROP
NS NS 2
NS NS NS
NS NS 2
NS 10 NS
NS NS 2
NS NS NS
NS NS 2
CA C46, GDI
G83 (21)
C20,
C46
CA C46, GDI
G83 (21)
C20,
CA C46,
CA C46,
C46
GDI
GDI
CA C14, C46
G83 (21)
CA C46,
(21) ,
, G01(12)
(21) ,
, G01(12)
(21)
(21)
, G01(21)
GDI (21)
C14, C20
G01(12)
C14,
C46
CA C14, C46
G83 (21)
CA C46,
, C46,
, G01(12)
, G01(21)
GDI (21)
C14, C20
G01(12)
, C46,
C14, C46, G01(12)
CORN, FIELD
Use Group: TERRESTRIAL FOOD+FEED CROP
60
-------
Date 08/03/94 ) Time 14:44
APPENDIX A ) CASE 0182, [Bentazon] Chemical 103901 [Bentazon]
LUIS 1.5 ) Page 3
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CORN, FIELD (con't)
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
CORN, POP
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
CORN, SWEET
Spray., Postemergence., Aircraft.
F1C
F1C
SC/L
SC/L
F1C
F1C
SC/L
SC/L
F1C
F1C
SC/L
SC/L
F1C
F1C
SC/L
SC/L
F1C
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
.726 Ib (AE) A *
UC *
1 Ib (AE) A *
UC *
.726 Ib (AE) A *
UC *
1 Ib (AE) A *
UC *
Use Group
.726 Ib (AE) A *
UC *
1 Ib (AE) A *
UC *
.726 Ib (AE) A *
UC *
1 Ib (AE) A *
UC *
Use Group
.726 Ib (AE) A *
: TERRESTRIAL
1
NS
NS
NS
1
NS
NS
NS
NS
1/1 yr
NS
NS
NS
1/1 yr
NS
NS
: TERRESTRIAL
1
NS
NS
NS
1
NS
NS
NS
NS
1/1 yr
NS
NS
NS
1/1 yr
NS
NS
: TERRESTRIAL
1
NS
FOOD+FEED
NS
NS
2 Ib
(AE)
UC
NS
NS
2 Ib
(AE)
UC
FOOD+FEED
NS
NS
2 Ib
(AE)
UC
NS
NS
2 Ib
(AE)
UC
FOOD+FEED
NS
CROP (con't)
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
10
NS
NS
NS
10
NS
NS
NS
10
NS
NS
NS
10
NS
2
NS
2
NS
2
NS
2
NS
2
NS
2
NS
2
NS
2
NS
2
C46, G01(21),
G83(21)
C46, G01(21)
C20, C46, G01(12)
C46, G01(12)
C46, G01(21),
G83(21)
C46, G01(21)
C20, C46, G01(12)
C46, G01(12)
C46, G01(21),
G83(21)
C46, G01(21)
C20, C46, G01(12)
C46, G01(12)
C46, G01(21),
G83(21)
C46, G01(21)
C20, C46, G01(12)
C46, G01(12)
C46, G01(21),
G83(21)
61
-------
Date 08/03/94 ) Time 14:44
APPENDIX A ) CASE 0182, [Bentazon] Chemical 103901 [Bentazon]
LUIS 1.5 ) Page 4
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CORN, SWEET (con't)
Use Group: TERRESTRIAL FOOD+FEED CROP (con't)
Spray., Postemergence., Ground.
PEANUTS
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
PEANUTS (UNSPECIFIED)
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
PEAS, DRIED-TYPE
Spray., Postemergence., Aircraft.
F1C
SC/L
SC/L
F1C
F1C
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
UC *
1 Ib (AE) A *
UC *
.726 Ib (AE) A *
UC *
1 Ib (AE) A *
UC *
Use Group
UC *
UC *
Use Group
.501 Ib (AE) A *
1 Ib (AE) A *
UC *
.501 Ib (AE) A *
1 Ib (AE) A *
UC *
Use Group
1 Ib (AE) A *
UC *
NS
NS
NS
1
NS
NS
NS
1/1 yr
NS
NS
NS
1/1 yr
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
1 Ib
(AE)
UC
NS
NS
1 Ib
(AE)
UC
FEED CROP
UC
UC
FOOD+FEED
1.001
Ib (AE)
2 Ib
(AE)
UC
1.001
Ib (AE)
2 Ib
(AE)
UC
FOOD+FEED
2 Ib
(AE)
UC
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
10
NS
NS
NS
10
NS
NS
15
NS
NS
15
NS
NS
NS
NS
NS
2
NS
2
NS
2
NS
NS
NS
2
2
NS
2
2
NS
2
NS
C46, G01(21)
C20, C46, G01(12)
C46, G01(12)
C46, G01(21),
G83(21)
C46, G01(21)
C20, C46, G01(12)
C46, G01(12)
C46, GOl(SO)
C46, GOl(SO)
C46, GD7, HOI(75)
C20, C46, GOl(SO),
G10, GI5
C46, GDI(50)
C46, GD7, HOI(75)
C20, C46, GOl(SO),
G10, GI5
C46, GDI(50)
C20, C46, HOI(30)
C46, HOI(30)
62
-------
Date 08/03/94 ) Time 14:44
44444444444444444444444444444
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
)))))))))))))))))))))))
PEAS, DRIED-TYPE (con't)
Spray., Postemergence., Ground.
PEAS, SOUTHERN
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
PEAS, SUCCULENT
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
PEPPER (CHILI TYPE)
Spray., Postemergence., Ground.
PEPPERMINT
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
RICE
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
APPENDIX A ) CASE 0182, [Bentazon] Chemical 103901 [Bentazon]
LUIS 1.5 ) Page 5
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) Dose cycle /crop /year [day(s)]
cycle
Use Group: TERRESTRIAL
SC/L NA
SC/L NA
1 Ib (AE) A * NS
UC * NS
NS
NS
Use Group: TERRESTRIAL
SC/L NA
SC/L NA
1 Ib (AE) A * NS
1 Ib (AE) A * NS
NS
NS
Use Group: TERRESTRIAL
SC/L NA
SC/L NA
SC/L NA
SC/L NA
1 Ib (AE) A * NS
UC * NS
1 Ib (AE) A * NS
UC * NS
NS
NS
NS
NS
Use Group: TERRESTRIAL
SC/L NA
1 Ib (AE) A * NS
NS
Use Group: TERRESTRIAL
SC/L NA
SC/L NA
SC/L NA
SC/L NA
2 Ib (AE) A * NS
UC * NS
2 Ib (AE) A * NS
UC * NS
NS
NS
NS
NS
Use Group: AQUATIC POOD
SC/L NA
SC/L NA
UC * NS
UC * NS
NS
NS
FOOD+FEED
2 Ib
(AE)
UC
FOOD+FEED
2 Ib
(AE)
2 Ib
(AE)
FOOD+FEED
2 Ib
(AE)
UC
2 Ib
(AE)
UC
FOOD CROP
2 Ib
(AE)
FOOD+PEED
4 Ib
(AE)
UC
4 Ib
(AE)
UC
CROP
UC
UC
CROP (con't)
NS NS 2
NS NS NS
CROP
NS NS 2
NS NS 2
CROP
NS NS 2
NS NS NS
NS NS 2
NS NS NS
NS NS NS NC
CROP
NS 7 2
NS NS NS
NS 7 2
NS NS NS
NS NS NS
NS NS NS
C20, C46, HOI (30)
C46, HOI (30)
C20, C46, HOI (30)
C20, C46, HOI (30)
C20, C46, HOI (30)
C46, HOI (30)
C20, C46, HOI (30)
C46, HOI (30)
C46
C20, C46
C46
C20, C46
C46
CA C46
CA C46
63
-------
Date 08/03/94 ) Time 14:44
APPENDIX A ) CASE 0182, [Bentazon] Chemical 103901 [Bentazon]
LUIS 1.5 ) Page
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
)))))))))))))
RICE (con't)
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
Spray., Ratoon., Aircraft.
Spray., Ratoon., Ground.
SORGHUM
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
SC/L NA
SC/L NA
SC/L NA
SC/L NA
SC/L NA
SC/L NA
SC/L NA
SC/L NA
SC/L NA
SC/L NA
SC/L NA
SC/L NA
F1C NA
SC/L NA
SC/L NA
F1C NA
Use Group: TERRESTRIAL FEED CROP
UC * NS NS
UC * NS NS
Use Group: TERRESTRIAL FOOD+FEED
L.98 Ib (AE) A * NS NS 2.97 Ib
1 Ib (AE) A * NS NS
L.98 Ib (AE) A * NS NS 2.97 Ib
1 Ib (AE) A * NS NS
.99 Ib (AE) A * NS NS 2.97 Ib
1 Ib (AE) A * NS NS
.99 Ib (AE) A * NS NS 2.97 Ib
1 Ib (AE) A * NS NS
UC * NS NS UC
Use Group: TERRESTRIAL FEED CROP
.726 Ib (AE) A * 1 NS NS
UC
UC
DOD+FEED
i7 Ib
(AE)
3 Ib
(AE)
i7 Ib
(AE)
3 Ib
(AE)
i7 Ib
(AE)
3 Ib
(AE)
UC
i7 Ib
(AE)
3 Ib
(AE)
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
NS
2
NS
2
NS
NS
2
CA C46
CA C46
G59, G60
CA C20, C46, G59,
GM5
G59, G60
CA C20, C46, G59,
GM5
G59, G60
CA C20, C46, G59,
GM5
CA C46
G59, G60
CA C20, C46, G59,
GM5
G60
G60
G60
G60
1 Ib (AE) A * NS NS
UC
Ib (AE) A
NS NS
1 NS
1 Ib
(AE)
UC
NS
NS NS
NS NS
NS NS
NS
2
C46, G01(21),
G83(21)
C20, C46, G01(12)
C46, G01(12)
C46, G01(21),
G83(21)
64
-------
Date 08/03/94 ) Time 14:44
APPENDIX A ) CASE 0182, [Bentazon] Chemical 103901 [Bentazon]
LUIS 1.5 ) Page 7
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed
otherwise) Dose cycle
/crop
cycle
/year
[day(s) ]
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SORGHUM (con't)
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
SOYBEANS (UNSPECIFIED)
Spray., Postemergence., Aircraft.
SC/L NA
SC/L NA
F1C NA
SC/L NA
SC/L NA
SC/L NA
SC/L NA
SC/L NA
Use Group: TERRESTRIAL FEED CROP (con't)
1 Ib (AE) A * NS NS 1 Ib NS NS
(AE)
UC * NS NS UC NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
.726 Ib (AE) A * 1 NS NS NS NS
F1C
SC/L
SC/L
F1C
F1C
SC/L
NA
NA
NA
NA
NA
NA
UC
1 Ib (AE) A
UC
.726 Ib (AE) A
UC
1 Ib (AE) A
* NS
* NS
* NS
* 1
* NS
* NS
1/1 yr
NS
NS
NS
1/1 yr
NS
NS
1 Ib
(AE)
UC
NS
NS
1 Ib
(AE)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
NS
2
NS
2
UC * NS NS UC NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
.499 Ib (AE) A * NS 1/1 yr NS NS NS
.748 Ib (AE) A * NS 1/2 yr .748 Ib NS NS
(AE)
.501 Ib (AE) A * NS NS 1.001 NS 15
Ib (AE)
.75 Ib (AE) A * NS NS 1.125 NS NS
Ib (AE)
AL, AR, DE, GA,
KY, LA, MD, MS,
NC, NJ, PA, SC,
TN, VA, MO, IN,
IL, ME, MA, NH,
NY, OH, RI, VT,
WV, IA
DE, NY, OH, WV,
IL, IN, KY, MD,
MA, ME, NH, RI,
MO, NJ, PA, VA
C20, C46, G01(12)
C46, G01(12)
C46, G01(21),
G83(21)
C46, G01(21)
C20, C46, G01(12)
C46, G01(12)
C46, G01(21),
G83(21)
C46, G01(21)
C20, C46, G01(12)
C46, G01(12)
C46, GA6
C13, C46, GA6
C46, GD7, HOI(50)
C46, GD7, HOI(50)
65
-------
Date 08/03/94 ) Time 14:44
APPENDIX A ) CASE 0182, [Bentazon] Chemical 103901 [Bentazon]
LUIS 1.5 ) Page
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed
otherwise) Dose cycle
/crop
cycle
/year
[day(s) ]
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
)))))))))))))))))))))))
SOYBEANS (UNSPECIFIED) (con't)
Spray., Postemergence., Ground.
SPEARMINT
Spray., Postemergence., Aircraft.
Spray., Postemergence., Ground.
NON- FOOD/NON- FEED
SC/L NA
SC/L NA
SC/L NA
SC/L NA
SC/L NA
SC/L NA
SC/L NA
Use Group: TERRESTRIAL FOOD+FEED CROP (con't)
1 Ib (AE) A * NS NS 2 Ib NS NS 2
UC * NS NS
.499 Ib (AE) A * NS 1/1 yr
2 Ib
(AE)
UC
NS
NS 14 NS
NS NS NS
.748 Ib (AE) A * NS 1/2 yr .748 Ib NS NS NS
(AE)
.501 Ib (AE) A * NS NS 1.001 NS 15
Ib (AE)
.75 Ib (AE) A * NS NS 1.125 NS NS
Ib (AE)
SC/L
SC/L
SC/L
SC/L
SC/L
NA
NA
NA
NA
NA
1 Ib (AE) A *
UC *
Use Group
2 Ib (AE) A *
UC *
2 Ib (AE) A *
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
2 Ib
(AE)
UC
FOOD+FEED
4 Ib
(AE)
UC
4 Ib
(AE)
NS
NS
CROP
NS
NS
NS
NS
14
7
NS
7
2
NS
2
NS
2
UC * NS NS
UC NS NS
AL, AR, DE, GA,
KY, LA, MD, MS,
NC, NJ, PA, SC,
TN, VA, MO, IN,
IL, ME, MA, NH,
NY, OH, RI, VT,
WV, IA
DE, NY, OH, WV,
IL, IN, KY, MD,
MA, ME, NH, RI,
MO, NJ, PA, VA
C20, C46, G01(30) ,
HOI (30)
C46, GN6
C46, GA6
C13, C46, GA6
C46, GD7, HOI(50)
C46, GD7, HOI(50)
C20, C46, G01(30),
HOI (30)
C46, GN6
C20, C46
C46
C20, C46
C46
ORNAMENTAL LAWNS AND TURF
Spray., Postemergence., Ground.
F1C NA
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
.726 Ib (AE) A * NS NS NS NS 7 NS
C13, C46, GA4, GC1
66
-------
Date 08/03/94 ) Time 14:44 APPENDIX A ) CASE 0182, [Bentazon] Chemical 103901 [Bentazon] LUIS 1.5 ) Page 9
4444444
LEGEND
444444
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps ® Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
F1C : FLOWABLE CONCENTRATE
SC/L : SOLUBLE CONCENTRATE/LIQUID
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
C13 : Groundwater restriction.
C14 : Grown for seed only.
C20 : Endangered species restriction.
C46 : Do not apply through any type of irrigation system.
G01 : day(s) pregrazing interval.
G59 : Do not apply where catfish are considered commercial resources.
G60 : Do not apply where crayfish are considered commercial resources.
G99 : Do not feed or graze animals on treated areas.
GA4 : Do not feed treated forage to livestock.
GAS : Do not graze treated areas or harvest for forage or hay.
GC1 : Do not graze treated areas.
GD7 : Do not use treated plants for feed or forage.
GM5 : Straw from harvested fields may be used for feed.
GN6 : Do not cut crop for feed or graze within 30 days after application.
HOI : day(s) preharvest interval.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES
AL : Alabama
AR : Arkansas
CA : California
DE : Delaware
GA : Georgia
IA : Iowa
IL : Illinois
67
-------
IN : Indiana
KY : Kentucky
LA : Louisiana
MA : Massachussets
MD : Maryland
ME : Maine
MO : Missouri
MS : Mississippi
NC : North Carolina
NH : New Hampshire
NJ : New Jersey
NY : New York
OH : Ohio
PA : Pennsylvania
RI : Rhode Island
SC : South Carolina
TN : Tennessee
VA : Virginia
VT : Vermont
WA : Washington
WV : West Virginia
68
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
69
-------
70
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case BENTAZON covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to BENTAZON in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
0 Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
71
-------
72
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Bentazon
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-2A
61-2B
62-1
63-7
63-10
63-11
63-12
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Density
Dissociation Constant
Octanol/Water Partition
PH
All
All
All
All
00157712, 00165273
00165273, 00148848
40549003, 00165274
00157712, 00155470
00157712, 00155470
00155470, 00157712
00157712, 00155470
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
71-4A
71-4B
72-1A
72-1B
72-1C
72-1D
72-2A
72-2B
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Bluegill - TEP
Fish Toxicity Rainbow Trout
Fish Toxicity Rainbow Trout- TEP
Invertebrate Toxicity
Invertebrate Toxicity - TEP
ABC
ABC
ABC
ABC
ABC
ABC
C
ABC
C
ABC
C
73
00161296, 00041804, 00041077
00161297
00164084
42617501
42651201
00161299, 00161300
00161300
41922801
41922802, 41922801
00161303
00161304
-------
Data Supporting Guideline Requirements for the Reregistration of Bentazon
REQUIREMENT
USE PATTERN
CITATION(S)
72-3A Estuarine/Marine Toxicity - Fish
72-3B Estuarine/Marine Toxicity -
Mollusk
72-3C Estuarine/Marine Toxicity -
Shrimp
123-1A Seed Germination/Seedling
Emergence
123-1B Vegetative Vigor
123-2 Aquatic Plant Growth
141-1 Honey Bee Acute Contact
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity -
Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
82-1A 90-Day Feeding - Rodent
82-IB 90-Day Feeding - Non-rodent
82-2 21-Day Dermal - Rabbit/Rat
83-1A Chronic Feeding Toxicity - Rodent
83-IB Chronic Feeding Toxicity -
Non-Rodent
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
42129601
42293501
42129602
42129607
42129606
42129603, 42129604, 42129605, 42129608,
42129609
00161305
00064314
00041088
40549008, 40232304, 00164089
00072791
40222201
40222201
42885302
40871701, 40871702
41054901
74
-------
Data Supporting Guideline Requirements for the Reregistration of Bentazon
REQUIREMENT
USE PATTERN
CITATION(S)
83-2A Oncogenicity - Rat
83-2B Oncogenicity - Mouse
83-3A Developmental Toxicity - Rat
83-3B Developmental Toxicity - Rabbit
83-4 2-Generation Reproduction - Rat
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
85-1 General Metabolism
85-2 Dermal Penetration
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
162-3 Anaerobic Aquatic Metabolism
162-4 Aerobic Aquatic Metabolism
163-1 Leaching/Adsorption/Desorption
164-1 Terrestrial Field Dissipation
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
A
AB
A
C
C
ABC
ABC
40871701
40871701, 40871702
40114201
40114202
41054902
42129610, 00158382
00158387, 00158388
4212960
40481801, 00158379
00158380
00161293
41447702, 41432401, 41448001
41447703, 00161295
40470502
00040204, 00040208
40470503
40470504
40470501, 40470502, 40470503, 40470504,
40470505
TRID 470119-015
75
-------
REQUIREMENT
USE PATTERN
CITATION(S)
165-1 Confined Rotational Crop
165-2 Field Rotational Crop
165-4 Bioaccumulation in Fish
RESIDUE CHEMISTRY
171-4A Nature of Residue - Plants
171-4B Nature of Residue - Livestock
171-4D Residue Analytical Method -
Animal
171-4E Storage Stability
171-4J Magnitude of Residues -
Meat/Milk/Poultry/Egg
171-4K Crop Field Trials
171-4L Processed Food
A
A
ABC
ABC
ABC
ABC
ABC
ABC
ABC
ABC
42361901
41146601, 41146602, 41146603, 41146604,
41146605, 41146606, 41146607, 41146608
42236501, 00108300, 40954801
41779501, 41779503
41779502
41730101
42587004, 42587005, 42587006, 42587007,
42587008, 42587009
41730101
41101701, 41101702
41123101, 42587001, 42587003, 42587002
76
-------
APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of BENTAZON
The bibliography for bentazon is over 100 pages and is therefore not being included with the
RED. It is, however, available upon request.
77
-------
-------
APPENDIX D. List of Available Related Documents
The following is a list of available documents related to BENTAZON. Its purpose is
to provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for BENTAZON 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. BENTAZON RED Fact Sheet
Note that the fact sheet is included with this document, but is also available
separately.
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
79
-------
-------
APPENDIX E. PR Notices 86-5 and 91-2
81
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
tPBOl WASHINGTON, B.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION,PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Pers9ns responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and certain provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining
pesticide registrations, experimental use permits, tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA. These data are defined in FIFRA §10(d)(1). This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
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 (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
83
-------
entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.
V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be C9mpatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen is to avoid the additional C9sts and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of applicati9n
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
deadlines for inserting int9 the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each application
for registration or other action include a list 9f all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support f9r the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party. That requirement is not altered by this notice, which
applies only to data submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements
foll9ws the index on the next page, and samples of some of the
requirements are attached. Except for the language 9f the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies . . 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
84
-------
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10 (d) (1)1 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(1) ) 8 14
D. 5 Good Laboratory Practice Compliance Statement . . 9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies .... 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at
the same time f9r review in support of a single regulatory
action, along with a transmittal document and other related
administrative material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this Notice. The transmittal and any other admin-
istrative material must be gr9uped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims).
B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--!.e., a registration application,
petition, experimental use permit (EUPT, §3 (c) (2) (B) data
call-in, §6(a)(2) submittal, or a special review; the transmittal
date; and a list of all individual studies included in the
gackage in the order of their appearance, showing (usually by
uideline reference number) the data requirement(s) addressed by
each one. The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
85
-------
application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40 CFR 180.7
and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petiti9n and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
C9nventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with 39016 exceptions dis-
cussed in section C.I. Each study included in a submittal
Eackage must be bound as a separate entity. (See comments on
inding studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study on
each page (i.e., 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or mark and study number on each
page of the study, e g , Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
When a single study is extremely long, binding it in mul-
tiple V9lumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.1 Special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical C9ntrol data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
86
-------
produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61, 62, and 63) for
C9nventional pesticides, or for the equivalent subject range for
biorational pesticides. The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
second W9uld cover Guidelines 151-23 and 151-25; the third would
cover Guideline 151-26.
Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
§10(d)(1)(A), (B) , or (C), and if so must be handled as described
in section D.3. of this notice.
c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
h9wever, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from processing a
single crop. When more than one commodity is derived from a
single crop (such as beet tops and beet roots) residue data on
all such C9mmodities should be reported as a single study. When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports Iaborat9ry Page 16
work subject to GLP require-
ments
For certain t9xicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C)
CBI Attachment
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C) Page 15
Supplemental Statement Only if confidentiality is Page 14
of Data Confidentiality claimed on a basis other than
Claims FIFRA §10(d)(1)(A), (B), or (C)
87
-------
D.I. Title Page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study title. The study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears in
the Guidelines.
b. Data requirement addressed. Include on the title page the
Guideline number(s) of the specific requirement(s) addressed by
the study.
c. Author(s). Cite only individuals with primary intellectual
responsibility for the C9ntent 9f the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory IdentificatJ9n. If the study reports
work done by one or more laboratories,Include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include 9n the title page elements a. through d. for the
previ9usly submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers. (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary study. Do not include supplements to more than one
study under a single title page).
g. Facts of Publication. If the study is a reprint of a pub-
lished d9cument, identity on the title page all relevant facts of
publication, such as the J9urnal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d) (1) .
Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 (b) and (c) (See
Attachment 3). These statements apply only to claims of data
confidentiality based on FIFRA §10(d)(1)(A), (B), or (C). Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or
to waive such a claim (§158.33(c)). In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. 09 not make CBI
claims with respect to analytical methods associated with pet-
-------
itions for tolerances or emergency exemptions (see NOTE Pg 13).
D.3. Confidential Attachment
If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
§10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body 9f the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5).
The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment." An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet. Paginate the Confidential Attachment
separately from the body of the study, beginning with page 1 of X
on the title page. Each passage confined t9 the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
§10(d)(1) on which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §10(d)
(1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement 9f Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us t9 retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies smpuld not be included in the transmit-
tal document, but should be incorp9rated into the statement of
the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed 9n one side only in
black ink, with high contrast and good res9lution. Bindings for
individual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
89
-------
instructions bef9re submitting data in any medium other than
paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than
black ink.
• Make sure that photocopies are clear, complete, and
fully readable.
• Do not include oversize computer printouts or fold-out
pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence.
Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The prop9sed regulati9ns specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Stan-
dard 9r Special Review must be provided in four C9pies, fr9m one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data
Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d)(1)(A), (B), or (C). Do not
close up or paraphrase text remaining after this
excision.
• Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential".
90
-------
V. For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality
Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample G9od Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
91
-------
ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
"Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
"Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is
submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g. experimental
use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline
No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-
smittal letter. This remains an acceptable practice so
long as all four elements are included.
* Indicate which of the J9int submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data.
Company Official:
Name Signature
Company Name
Company Contact:
Name Phone
92
-------
ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
93
-------
ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(1)(A),(B), or (C).
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this
study on the basis of its falling within the scope of FIFRA
6§10(d)(1)(A), (B), or (C).
Company
Company Agent: Typed Name Date:
Title Signature
2. Claim of confidentiality under FIFRA §10(d)(1)(A), (B), or (C).
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent: Typed Name Date:
Title Signature
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method. These
analytical methods are published in the FDA Pesticide Analytical
Meth9ds Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
94
-------
ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1)(A), (B), or (C), but for which y9u claim
C9nfidential treatment 9n another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
• Identify specifically by page and line number(s) each
portion of the study for which you claim
confidentiality.
• Cite the reasons why the cited passage qualifies for
confidential treatment.
• Indicate the length of time--until a specific date or
event, or permanently--for which the information should
be treated as confidential.
• Identify the measures taken to guard against undesired
disclosure of this information.
• Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
• Encl9se C9pies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
• If y9u assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe th9se harmful effects and explain why
they should be viewed as substantial.
• If you assert that the informati9n in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
95
-------
ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the following
paragraph(s) at the indicated volume and page references.
DELETED WORDS OR PHRASE: Ethylene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
100 19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study in place of the following
paragraph(s) at the indicated volume and page references.
DELETED PARAGRAPH (S):
( )
( Reproduce the deleted paragraph (s) here )
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process §10(d)(l)(C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the following
paragraph(s) at the indicated volume and page references.
DELETED PAGES (S): are attached immediately behind this page
PAGES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process §10(d)(l)(A)
96
-------
ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1.
2.
3.
Submitter
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
97
-------
ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
• Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims
When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
LEGEND
98
-------
1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
/ WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide P^gram's P9licy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CFR 158.153(1). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
9f identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting go9d manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175(c)(3).
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
99
-------
product compositi9n because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is imp9rtant for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal C9ncentrati9n expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. C9pies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to pr9vide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i. e., upper limit(s) 9nly) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to C9ntrol pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
100
-------
(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
(3) All other products/applications that are not subject to
(1) and (2) ab9ve will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
101
-------
-------
APPENDIX F. Combined Generic and Product Specific
Data Call-In
103
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
.^iK^- WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL January 27, 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 ofyour product(s)
containing this active ingredient. Within 90 days after you receive this Notice you must respond
as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 7; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3 (for both generic and product specific data), the Requirements
Status and Registrant's Response Form, (see section III-B); or
3. Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all 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
105
-------
Section III - Compliance with Requirements of this Notice
Section IV - Consequences of Failure to Comply with this Notice
Section V - Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Section VI - Inquiries and Responses to this Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
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 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregi strati on
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reeyaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because you
have product(s) containing the subject active ingredients.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and Registrant's
Response Forms: Attachment 3 (for both generic and product specific data requirements).
Depending on the results of the studies required in this Notice, additional studies/testing may be
required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified
in the Requirements Status and Registrant's Response Forms (Attachment 3) within the
timeframes provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which guidelines
have been established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
106
-------
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 willnpt 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].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED
BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change
the requirements of any previous Data Call-In(s). or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to this
Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is
specified in item number 3 on the four Data Call-in forms (Attachments 2 and 3).
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for generic and product
specific data must be submitted to the Agency within 90 days after your receipt of this Notice.
Failure to adequately respond to this Notice within 90 days of your receipt will be a basis for
issuing a Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for
issuance of NOIS due to failure to comply with this Notice are presented in Section IV-A and
IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
1. Generic Data Requirements
The options for responding to this Notice for generic data requirements are: (a) voluntary
cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy the generic
data requirements imposed by this Notice or (e) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option, the
Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion of
the various options available for satisfying the generic data requirements of this Notice is
contained in Section III-C. A discussion of options relating to requests for data waivers is
contained in Section III-D.
Two forms apply to generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response. These two forms are the Data-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 Generic Data Exemption or are not requesting voluntary cancellation of your
107
-------
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 (if this form is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or write the contact person(s)
identified in Attachment 1.
a. Voluntary Cancellation -
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit completed Generic and Product Specific 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(sy 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 for amendment, a copy of your proposed amended labeling, and all other information
required for processing the application. Use deletion is option number 7 under item 9 in the
instructions for the Requirements Status and Registrant's Response Forms. You must also
complete a Data Call-In Response Form by signing the certification, item number 8.
Application forms for amending registrations may be obtained from the Registration Support
Branch, Registration Division, Office of Pesticide Programs, EPA, by calling (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due date
of your 90 day response, is allowed only if the product bears an amended label.
c. Generic Data Exemption -
Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is exempt
from the requirement to submit or cite generic data concerning an active ingredient if the active
ingredient in the product is derived exclusively from purchased, registered pesticide products
containing the active ingredient. EPA has concluded, as an exercise of its discretion, that it
normally will not suspend the registration of a product which would qualify and continue to
qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify, all of the
following requirements must be met:
(i). The active ingredient in your registered product must be present solely because of
incorporation of another registered product which contains the subject active ingredient
and is purchased from a source not connected with you;
(ii). Every registrant who is the ultimate source of the active ingredient in your product
subject to this DCI must be in compliance with the requirements of this Notice and must
remain in compliance; and
(iii). You must have provided to EPA an accurate and current "Confidential Statement of
Formula" for each of your products to which this Notice applies.
108
-------
To apply for the Generic Data Exemption you must submit a completed Data Call-In
Response Form. Attachment 2 and all supporting documentation. The Generic Data Exemption
is item number 6a on the Data Call-In Response Form. If you claim a generic data exemption
you are not required to complete the Requirements Status and Registrant's Response Form.
Generic Data Exemption cannot be selected as an option for responding to product specific data
requirements.
If you are granted a Generic Data Exemption, you rely on the efforts of other persons to
provide the Agency with the required data. If the registrant(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 of both your
and their product(s), unless you commit to submit and do submit the required data within the
specified time. In such cases the Agency generally will not grant a time extension for submitting
the data.
d. Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this
Notice. These options are discussed in Section III-C.l. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
Form and item 6b on the Data Call-In Response Form. If you choose item 6b (agree to satisfy
the generic data requirements), you must submit the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form as well as any other information/data
pertaining to the option chosen to address the data requirement. Your response must be on the
forms marked "GENERIC" in item number 3.
e. Request for Generic Data Waivers.
Waivers for generic data are discussed in Section III-D.l. of this Notice and are covered
by options 8 and 9 of item 9 in the instructions for the Requirements Status and Registrant's
Response Form. If you choose one of these options, you must submit both forms as well as any
other information/data pertaining to the option chosen to address the data requirement.
2. Product Specific Data Requirements
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this Notice
or (c) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C.2. A discussion of options relating
to requests for data waivers is contained in Section III-D.2.
Two forms apply to the product specific data requirements one or both of which must be
used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form, for
product specific data (contained in Attachments 2 and 3, respectively). The Data Call-in
Response Form must be submitted as part of every response to this Notice. In addition, one
copy of the Requirements Status and Registrant's Response Form also must be submitted for
each product listed on the Data 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 and Registrant's Response
Form (if this form is required) and initial any subsequent pages. The forms contain separate
detailed instructions on the response options. Do not alter the printed material. If you have
109
-------
questions or need assistance in preparing your response, call or write the contact person(s)
identified in Attachment 1.
a. Voluntary Cancellation
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit a completed Data Call-In Response Form.
indicating your election of this option. Voluntary cancellation is item number 5 on both the
Generic and Product Specific Data Call-In Response Forms. If you choose this
option, you must complete both Data Call-In response forms. These are the only forms that you
are required to complete.
If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
b. Satisfying the Product Specific Data Requirements of this Notice.
There are various options available to satisfy the product specific data requirements of
this Notice. These options are discussed in Section III-C.2. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the product specific Requirements Status and
Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product specific
data requirements for an MUP or EUP as applicable) on the product specific Data Call-In
Response Form. Note that the options available for addressing product specific data
requirements differ slightly from those options for fulfilling generic data requirements. Deletion
of a use(s) and the low volume/minor use option are not valid options for fulfilling product
specific data requirements. It is important to ensure that you are using the correct forms and
instructions when completing your response to the Reregi strati on Eligibility Decision document.
c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section III-D.2. of this Notice and are
covered by option 7 of item 9 in the instructions for the Requirements Status and Registrant's
Response Form. If you choose this option, you must submit the Data Call-In Response Form
and the Requirements Status and Registrant's Response Form as well as any other
information/data pertaining to the option chosen to address the data requirement. Your response
must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1. Generic Data
If you acknowledge on the Generic Data Call-In Response Form that you agree to satisfy
the generic data requirements (i.e. you select item number 6b), then you must select one of the
six options on the Generic Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide you to additional instructions
provided in this Section. The options are:
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)
110
-------
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
CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and be in
conformance with the requirements of PR Notice 86-5. In addition, certain studies require
Agency approval of test protocols in advance of study initiation. Those studies for which a
protocol must be submitted have been identified in the Requirements Status and Registrant's
Response Form and/or footnotes to the form. If you wish to use a protocol which differs from
the options discussed in Section II-C of this Notice, you must submit a detailed description of
the proposed protocol and your reason for wishing to use it. The Agency may choose to reject a
protocol not specified in Section II-C. If the Agency rejects your protocol you will be notified in
writing, however, you should be aware that rejection of a proposed protocol will not be a basis
for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from the date you are
required to commit to generate or undertake some other means to address that study requirement,
such as making an offer to cost share or agreeing to share in the cost of developing that study.
This 90-day progress report must include the date the study was or will be initiated and, for
studies to be started within 12 months of commitment, the name and address of the
laboratory(ies) or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year, interim
reports must be submitted at 12 month intervals from the date you are required to commit to
generate or otherwise address the requirement for the study. In addition to the other information
specified in the preceding paragraph, at a minimum, a brief description of current activity on and
the status of the study must be included as well as a full
description of any problems encountered since the last progress report.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports or protocols.
The noted deadlines run from the date of the receipt of this Notice by the registrant. If the data
are not submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to
Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
111
-------
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.
Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful, you may
request EPA (by selecting this option) to exercise its discretion not to suspend your
registration(s), although you do not comply with the data submission requirements of this
Notice. EPA has determined that as a general policy, absent other relevant considerations, it will
not suspend the registration of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but the other
registrant(s) developing the data has refused to accept the offer. To qualify for this option, you
must submit documentation to the Agency proving that you have made an offer to another
registrant (who has an obligation to submit data) to share in the burden of developing that data.
You must also submit to the Agency a completed EPA Form 8570-32, Certification of Offer to
Cost Share in the Development of Data, Attachment 7. In addition, you must demonstrate that
the other registrant to whom the offer was made has not accepted your offer to enter into a cost-
sharing agreement by including a copy of your offer and proof of the other registrant's receipt of
that offer (such as a certified mail receipt). Your offer must, in addition to anything else, offer to
share in the burden of producing the data upon terms to be agreed to or, failing agreement, to be
bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify
this offer. The other registrant must also inform EPA of its election of an option to develop and
submit the data required by this Notice by submitting a Data Call-In Response Form and a
Requirements Status and Registrant's Response Form committing to develop and submit the data
required by this 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 other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant
fails to develop the data or for some other reason is subject to suspension, your registration as
well as that of the other registrant normally will be subject to initiation of suspension
proceedings, unless you commit to submit, and do submit, the required data in the specified time
frame. In such cases, the Agency generally will not grant a time extension for submitting the
data.
Option 4. Submitting an Existing Study
If you choose to submit an existing study in response to this Notice, you must determine
that the study satisfies the requirements imposed by this Notice. You may only submit a study
that has not been previously submitted to the Agency or previously cited by anyone. Existing
studies are studies which predate issuance of this Notice. Do not use this option if you are
submitting data to upgrade a study. (See Option 5).
112
-------
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly Met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part
160. As stated in 40 CFR 160.3 'Raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from automated
instruments." The term "specimens", according to 40 CFR 160.3, means "any
material derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 also must also contain all
GLP-required quality assurance and quality control information, pursuant to the
requirements 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 Reregi strati on 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.
113
-------
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.
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 7b), 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
114
-------
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
jointly (Cost Sharing)
I have made offers to cost-share (Offers to Cost Share)
4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been
submitted but not reviewed by the Agency (Citing an Existing Study)
Option 1. Developing Data — The requirements for developing product specific data are the
same as those described for generic data (see Section III.C.I, Option 1) except that normally no
protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data — If you enter into an agreement to cost share,
the same requirements apply to product specific data as to generic data (see Section III.C.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 option.
Option 3. Offer to Share in the Cost of Data Development —The same requirements for generic
data (Section III.C.L, Option 3) apply to this option. This option only applies to acute toxicity
and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study — The same requirements described for generic data (see
Section III.C.l., Option 4) apply to this option for product specific data.
Option 5. Upgrading a Study — The same requirements described for generic data (see Section
III.C.l., Option 5) apply to this option for product specific data.
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section III.C.l., Option 6) apply to this option for product specific data.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (III.C.l.), as appropriate.
III-D REQUESTS FOR DATA WAIVERS
1. Generic Data
There are two types of data waiver responses to this Notice. The first is a request for a
low volume/minor use waiver and the second is a waiver request based on your belief that the
data requirement(s) are not appropriate for your product.
115
-------
a. Low Volume/Minor Use Waiver
Option 8 under item 9 on the Requirements Status and Registrant's Response
Form. Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of
requiring data for low volume, minor use pesticides. In implementing this provision,
EPA considers low volume pesticides to be only those active ingredients whose total
production volume for all pesticide registrants is small. In determining whether to grant a
low volume, minor use waiver, the Agency will consider the extent, pattern and volume
of use, the economic incentive to conduct the testing, the importance of the pesticide, and
the exposure and risk from use of the pesticide. If an active ingredient is used for both
high volume and low volume uses, a low volume exemption will not be approved. If all
uses of an active ingredient are low volume and the combined volumes for all uses are
also low, then an exemption may be granted, depending on review of other information
outlined below. An exemption will not be granted if any registrant of the active
ingredient elects to conduct the testing. Any registrant receiving a low volume minor use
waiver must remain within the sales figures in their forecast supporting the waiver
request in order to remain qualified for such waiver. If granted a waiver, a registrant will
be required, as a condition of the waiver, to submit annual sales reports. The Agency will
respond to requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the following
information, as applicable to your product(s), as part of your 90-day response to this
Notice:
(i). Total company sales (pounds and dollars) of all registered product(s)
containing the active ingredient. If applicable to the active ingredient, include foreign
sales for those products that are not registered in this country but are applied to sugar
(cane or beet), coffee, bananas, cocoa, and other such crops. Present the above
information by year for each of the past five years.
(ii) Provide an estimate of the sales (pounds and dollars) of the active ingredient
for each major use site. Present the above information by year for each of the past five
years.
(iii) Total direct production cost of product(s) containing the active ingredient by
year for the past five years. Include information on raw material cost, direct labor cost,
advertising, sales and marketing, and any other significant costs listed separately.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product(s) containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were directly related to the active
ingredient, such as costs of initial registration and any data development.
(v) A list of each data requirement for which you seek a waiver. Indicate the type
of waiver sought and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill each of these
data requirements.
(vi) A list of each data requirement for which you are not seeking any waiver and
the estimated cost to you (listed separately for each data requirement and associated test)
of conducting the testing needed to fulfill each of these data requirements.
(vii) For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient, direct production costs of product(s)
containing the active ingredient (following the parameters in item 2 above), indirect
116
-------
production costs of product(s) containing the active ingredient (following the parameters
in item 3 above), and costs of data development pertaining to the active ingredient.
(viii) A description of the importance and unique benefits of the active ingredient
to users. Discuss the use patterns and the effectiveness of the active ingredient relative to
registered alternative chemicals and non-chemical control strategies. Focus on benefits
unique to the active ingredient, providing information that is as quantitative as possible.
If you do not have quantitative data upon which to base your estimates, then present the
reasoning used to derive your estimates. To assist the Agency in determining the degree
of importance of the active ingredient in terms of its benefits, you should provide
information on any of the following factors, as applicable to your product(s): (a)
documentation of the usefulness of the active ingredient in Integrated Pest Management,
(b) description of the beneficial impacts on the environment of use of the active
ingredient, as opposed to its registered alternatives, (c) information on the breakdown of
the active ingredient after use and on its persistence in the environment, and (d)
description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the request
for a waiver.
b. Request for Waiver of Data
Option 9, under Item 9, on the Requirements Status and Registrant's Response
Form. This option may be used if you believe that a particular data requirement should
not apply because the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You also must
submit the current label(s) of your product(s) and, if a current copy of your Confidential
Statement of Formula is not already on file you must submit a current copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice are not appropriate to your
product(s), you will not be required to supply the data pursuant to section 3(c)(2)(B). If
EPA determines that the data are required for your proauctfs). you must choose a method
of meeting the requirements of this Notice within the time frame provided by this Notice.
Within 30 days of your receipt of the Agency's written decision, you must submit a
revised Requirements Status and Registrant's Response Form indicating the option
chosen.
2. Product Specific Data
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note:
any supplemental data must be submitted in the format required by PR Notice 86-5). This
will be the only opportunity to state the reasons or provide information in support of your
request. If the Agency approves your waiver request, you will not be required to supply
the data pursuant to section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver
request, you must choose an option for meeting the data requirements of this Notice
within 30 days of the receipt of the Agency's decision. You must indicate and submit the
option chosen on the product specific Requirements Status and Registrant's Response
Form. Product specific data requirements for product chemistry, acute toxicity and
efficacy (where appropriate) are required for all products and the Agency would grant a
waiver only under extraordinary circumstances. You should also be aware that
submitting a waiver request will not automatically extend the due date for the study in
117
-------
question. Waiver requests submitted without adequate supporting rationale will be denied
and the original due date will remain in force.
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 by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
i. Inform EPA of intent to develop and submit the data required by this Notice on
a Data Call-In Response Form and a Requirements Status and Registrant's
Response Form.
ii. Fulfill the commitment to develop and submit the data as required by this
Notice; or
iii. Otherwise take appropriate steps to meet the requirements stated in this
Notice,
unless you commit to submit and do submit the required data in the specified time
frame.
118
-------
9. Failure to take any required or appropriate steps, not mentioned above, at any
time following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1) EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection of
species, number of animals, sex and distribution of animals, dose and effect levels to be
tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2) EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3) EPA requirements regarding the reporting of data, including the manner of
reporting, the completeness of results, and the adequacy of any required supporting (or
raw) data, including, but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted in the form of a final
report; a preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding generally would not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may
be suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You also must explain why an "existing stocks" provision is necessary, including a statement of
the quantity of existing stocks and your estimate of the time required for their sale, distribution,
and use. Unless you meet this burden, the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due, unless you demonstrate
119
-------
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 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 Forms
(Attachment 3), for both (generic and product specific data) and any other documents required
by this Notice, and should be submitted to the contact person(s) identified in Attachment 1. If
the voluntary cancellation or generic data exemption option is chosen, only the Generic and
Product Specific Data Call-In Response Forms need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance
(OECA), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Louis P. True, Jr., Acting Director
Special Review and
Reregi strati on Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
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 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregi strati on
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Confidential Statement of Formula. Cost Share and Data Compensation Forms
120
-------
Attachment 1. Chemical Status Sheet
121
-------
-------
BENTAZON DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Data Call-In Notice because you have products containing
BENTAZON.
This Data Call-In Chemical Status Sheet, contains an overview of data required by this
notice, and point of contact for inquiries pertaining to the reregi strati on of BENTAZON. This
attachment is to be used in conjunction with (1) the Combined Generic and Product Specific
Data Call-In Notice, (2) the Data Call-In Response Forms (Attachment 2), (3) the Requirements
Status and Registrant's Forms (Attachment 3), (4) EPA's Batching of End-Use Products for
Meeting Acute Toxicology Data Requirements (Attachment 4), (5) the EPA Acceptance Criteria
(Attachment 5), (6) the list of registrants receiving this DCI (Attachment 6), and (7) the Cost
Share and Data Compensation Forms in replying to this BENTAZON Data Call-In (Attachment
7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for BENTAZON are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional generic product chemistry, ecological effects, toxicology,
environmental fate, and residue chemistry data on BENTAZON are needed. The Agency has
also concluded that additional data on BENTAZON are needed for specific products. These data
are required to be submitted to the Agency within the time frames listed. These data are needed
to fully complete the reregi strati on of all eligible BENTAZON products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements, please contact Eric
Feris at (703) 308-8048 via relay (800-828-1140) or by electronic mail at
FERIS.ERIC@EPAMAIL.EPA.GOV. All responses to this Notice for the generic data
requirements should be submitted to:
Eric Feris, Chemical Review Manager
Reregi strati on Branch
Special Review and Registration Division 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: BENTAZON
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Franklin Gee at (703) 308-8008. All
responses to this Notice for the Product Specific data requirements should be submitted to:
Frank Rubis, Chemical Review Manager Team 81
Product Reregi strati on Branch
Special Review and Reregi strati on Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: BENTAZON
123
-------
-------
Attachment 2. Combined Generic and Product Specific
Data Call-In Response Forms Plus Instructions
125
-------
-------
Instructions For Completing The "Data Call-In Response Forms" For The Generic And Product
Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-In Response Forms" and
are to be used by registrants to respond to generic and product specific Data Call-ins as part of
EPA's Reregi strati on Program under the Federal Insecticide, Fungicide, and Rodenticide Act.
The type of data call-in (generic or product specific) is indicated in item number 3 ("Date
and Type of DCI") on each form. BOTH "Data Call-In Response" forms must be completed.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling out
the forms.
EPA has developed these forms individually for each registrant, and has 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
the registrant as appropriate. 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 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.
127
-------
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item l.ON BOTH FORMS: This item identifies your company name, number and address.
Item 2.ON BOTH FORMS: This item identifies the case number, case name, EPA chemical
number and chemical name.
Item 3.ON BOTH FORMS: This item identifies the type of Data Call-In. The date of issuance
is date stamped.
Item 4.ON BOTH FORMS: This item identifies the EPA product registrations relevant to the
data call-in. Please note that you are also responsible for informing the Agency of your response
regarding any product that you believe may be covered by this Data Call-In but that is not listed
by the Agency in Item 4. You must bring any such apparent omission to the Agency's attention
within the period required for submission of this response form.
Item 5.ON BOTH FORMS: Check this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of that request. Since this Data Call-In
requires both generic and product specific data, you must complete item 5 on both Data Call-In
response forms. You do not need to complete any item on the Requirements Status and
Registrant's Response Forms.
Item 6a.ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for generic
data as indicated in Item 3 and you are eligible for a Generic Data Exemption for the chemical
listed in Item 2 and used in the subject product. By electing this exemption, you agree to the
terms and conditions of a Generic Data Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA registration Number of
each registered source of that active ingredient that you use in your product.
Typically, if you purchase an EPA-registered product from one or more other producers (who,
with respect to the incorporated product, are in compliance with this and any other outstanding
Data Call-in Notice), and
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
incorporate that product into all your products, you may complete this item for all products listed
on this form. If, however, you produce the active ingredient yourself, or use any unregistered
product (regardless of the fact that some of your sources are registered), you may not claim a
Generic Data Exemption and you may not select this item.
Item 6b.ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for generic
data as indicated in Item 3 and if you are agreeing to satisfy the generic data requirements of this
Data Call-in. Attach the Requirements Status and Registrant's Response Form that indicates how
you will satisfy those requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
128
-------
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 7b.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
Generic and Product Specific Data Call-In
Item 8.ON BOTH FORMS: This certification statement must be signed by an authorized
representative of your company and the person signing must include his/her title. Additional
pages used in your response must be initialled and dated in the space provided for the
certification.
Item 9.ON BOTH FORMS: Enter the date of signature.
Item 10.ON BOTH FORMS: Enter the name of the person EPA should contact with questions
regarding your response.
Item 1 l.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
129
-------
-------
131
-------
132
-------
133
-------
134
-------
Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms and Instructions
135
-------
-------
Instructions For Completing The "Data Call-In Response Forms" For The Generic And Product
Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-In Response Forms" and
are to be used by registrants to respond to generic and product specific Data Call-ins as part of
EPA's Reregistration Program under the Federal Insecticide, Fungicide, and Rodenticide Act. The
type of data call-in (generic or product specific) is indicated in item number 3 ("Date and
Type of DCI") on each form. BOTH "Data Call-In Response" forms must be completed.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling out the
forms.
EPA has developed these forms individually for each registrant, and has 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 the
registrant as appropriate. 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 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.
137
-------
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item l.ON BOTH FORMS: This item identifies your company name, number and address.
Item 2.ON BOTH FORMS: This item identifies the case number, case name, EPA chemical
number and chemical name.
Item 3.ON BOTH FORMS: This item identifies the type of Data Call-In. The date of issuance
is date stamped.
Item 4.ON BOTH FORMS: This item identifies the EPA product registrations relevant to the data
call-in. Please note that you are also responsible for informing the Agency of your response
regarding any product that you believe may be covered by this Data Call-In but that is not listed by
the Agency in Item 4. You must bring any such apparent omission to the Agency's attention within
the period required for submission of this response form.
Item 5.ON BOTH FORMS: Check this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of that request. Since this Data Call-In requires
both generic and product specific data, you must complete item 5 on both Data Call-In response
forms. You do not need to complete any item on the Requirements Status and Registrant's Response
Forms.
Item 6a.ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for generic data
as indicated in Item 3 and you are eligible for a Generic Data Exemption for the chemical listed in
Item 2 and used in the subject product. By electing this exemption, you agree to the terms and
conditions of a Generic Data Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA registration Number of
each registered source of that active ingredient that you use in your product.
Typically, if you purchase an EPA-registered product from one or more other producers (who, with
respect to the incorporated product, are in compliance with this and any other outstanding Data
Call-in Notice), and
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
incorporate that product into all your products, you may complete this item for all products listed
on this form. If; however, you produce the active ingredient yourself, or use any unregistered
product (regardless of the fact that some of your sources are registered), you may not claim a
Generic Data Exemption and you may not select this item.
Item 6b.ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for generic
data as indicated in Item 3 and if you are agreeing to satisfy the generic data requirements of this
Data Call-in. Attach the Requirements Status and Registrant's Response Form that indicates how
you will satisfy those requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
138
-------
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 7b.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
Generic and Product Specific Data Call-In
Item 8.ON BOTH FORMS: This certification statement must be signed by an authorized
representative of your company and the person signing must include his/her title. Additional pages
used in your response must be initialled and dated in the space provided for the certification.
Item 9.ON BOTH FORMS: Enter the date of signature.
Item 10.ON BOTH FORMS: Enter the name of the person EPA should contact with questions
regarding your response.
Item 1 l.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
139
-------
-------
141
-------
142
-------
143
-------
144
-------
Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
145
-------
-------
EPA'S BATCHING OF PRODUCTS CONTAINING BENTAZON 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 bentazon (3-isopropyl-lH-2, l,3-benzothiadiazin-4(3H)-one-2,2-dioxide, sodium
salt) 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.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process
described in the preceding paragraph. Notwithstanding the batching process, the Agency
reserves the right to require, at any time, acute toxicity data for an individual product should
the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit
or cite a single battery of six acute toxicological 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 toxicological studies for each of their own products. If a registrant
chooses to generate the data for a batch, he/she must use one of the products within the batch
as the test material. If a registrant chooses to rely upon previously submitted acute toxicity
data, he/she may do so provided that the data base is complete and valid by today's standards
(see acceptance criteria attached), the formulation tested is considered by EPA to be similar
for acute toxicity, and the formulation has not been significantly altered since submission
and acceptance of the acute toxicity data. Regardless of whether new data is generated or
existing data is referenced, registrants must clearly identify the test material by EPA
Registration Number. If more than one confidential statement of formula (CSF) exists for
a product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must
follow the directions given in the Data Call-In Notice and its attachments appended to the
RED. The DCI Notice contains two response forms which are to be completed and submitted
to the Agency within 90 days of receipt. The first form, "Data Call-in Response," asks
whether the registrant will meet the data requirements for each product. The second form,
"Requirements Status and Registrant's Response," lists the product specific data required for
each product, including the standard six acute toxicity tests. A registrant who wishes to
participate in a batch must decide whether he/she will provide the data or depend on
someone else to do so. If a registrant supplies the data to support a batch of products, he/she
must select one of the following options: Developing Data (Option 1), Submitting an
Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing
Study (Option 6). If a registrant depends on another's data, he/she must choose among: Cost
Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6).
If a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6.
However, a registrant should know that choosing not to participate in a batch does not
147
-------
preclude other registrants in the batch from citing his/her studies and offering to cost share
(Option 3) those studies.
Table 1 displays the batches for the products containing the active ingredient bentazon.
Table!
Batch
1
Registration Number
7969-45
NC8 1002300
WA90001200
% Active Ingredient
bentazon ... 42.0%
bentazon ... 42.0%
bentazon ... 42.0%
Form
liquid
liquid
liquid
2
7969-84
7969-112
bentazon ... 53.0%
bentazon... 53.0%
liquid
liquid
3
7969-54
7969-103
bentazon... 19.0%
atrazine ... 17.5%
bentazon... 19.0%
atrazine ... 17.5%
liquid
liquid
4
7969-82
7969-83
bentazon ...29.0%
fomesafen... 12.9%
bentazon ...29.8%
fomesafen... 7.2%
liquid
liquid
Table 2 lists those products the Agency was unable to batch. These products were
considered not to be similar to other products for purposes of acute toxicity. Registrants of
148
-------
these products are responsible for meeting the acute toxicity data requirements for each
product.
Table 2
Unbatched Products
Reg. No.
7969-42
7969-76
7969-77
7969-78
7969-100
% Active Ingredient
bentazon
bentazon
acifluorfen,
...46%
...29.2%
sodium salt ... 13.4%
bentazon ... 33.4%
acifluorfen, sodium salt ... 6.8%
bentazon
MCPA
bentazon
atrazine
... 37.0%
... 6.2%
...27.6%
...25.0%
Form
liquid
liquid
liquid
liquid
liquid
149
-------
-------
Attachment 5. EPA Acceptance Criteria
151
-------
-------
SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each intentionally-
added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at > 0.1% by weight and for
certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present at < 0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS) Registry
Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned
experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition, properties or
toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and the parameters
that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity which may
be present at _>_ 0.1% or was found at _>_ 0.1% by product analyses and (2) certain lexicologically significant impurities
(see #3).
62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present the information
in items 6, T, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and all
impurities present at > 0.1%.
2. Degree of accountability or closure _>_ ca 98%.
3. Analyses conducted for certain trace tdxTcTrnpurities at lower than 0.1% (examples, nitrosamines in the case of products
containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites; polyhalogenated
153
-------
dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and stored samples must be
analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with explanation
of now the limits were determined.
8. Upper certified limit proposed for each impurity present at > 0.1% and for certain lexicologically significant impurities
at < 0.1% along with explanation of how limit determines".
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt from
requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy.
63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic compounds"
Observed at room temperature
63-5 MeltingPoint
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
Reported in °C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with reference
to water at 20° C. [Note: Bulk density of registered products~~may be reported in lbs/ft3 or Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in formulations and
analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if pressure too low
to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25°C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
154
-------
Sensitivity to sunlight determined
SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3.^ Dosing, single oral may be administered over 24 hrs.
4. Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.^ Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.^ Vehicle control, only if toxicity of vehicle is unknown.
7.1 Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours oefore dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or contains
particles of inhalable size for man (aerodynamic diameter 15 pm or less).
155
-------
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (+_2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of respirable
substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24nours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of <7. or > 11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8. Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days (whichever
is snorter).
11.^ Individual daily observations.
81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof <2 or >11.5.
3. One oflhe following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
156
-------
Footpad technique in guinea pig.
4. Complete description of test.
5.^ Reference for test.
6C Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
157
-------
-------
Attachment 6. List of All Registrants Sent This Data Call-In Notice
159
-------
-------
161
-------
162
-------
Attachment 7. Cost Share Data Compensation Forms, Confidential Statement of
Formula Form and Instructions
163
-------
164
-------
•jf
S
yj
t
UJ
15
Q.
o
s
9
a
6
CQ
O
•D
i
Q.
<
p
O
11
.^^
(0
2
0
t^j
"^
_o
eg
"*•
3
U
CO
"5
c
|
Contain
Does Not
c
j
"£j
2
•S
OQ
!5
1
5
1
U
u
(U
m
c
0
(A
C.
Q
3
^
^
<0
E
o
LL
V
3
C
0
u
CD
6
z
(Q
0)
h-
O>
*^
3
O
£
2
LU
IT)
1
CO
[£
\
6
z
c
o
. Registra
*
c
o
Ul
c
X
UJ
0)
(Q
u.
c
"o
0.
£
(D
U.
CT>
X
Q.
00
~
C
ffl
Q
^
m
o
"3
(D
1
^
to
1
Q.
cr>
c
- c
V O
1-2
Q. 5
-
1
•o 5 ~*
5*1
^ s
^ a
^
1
I J
Si"
o 3
U £H
uj c E
f) _
*~ (D
6
Z
0?
(C
LU
^
U)
e & Addrf
E
z
1
3
U)
•~
'ntroduced
' chemical
II
^ 6 E
28 g
(0 n-CO
s in Formul
lation. G/V<
7)0, andCA.
Hi
§-§•§
|^s
u ~ S"
• S ^
Z
0
UJ
co
<
a.
UJ
*
8
2
O5
0>
5
2
o
1—
fh^
•-
"5
'3
D
a
o
Q.
f
"5
o
E
(0
•a
o
a.
cb
2
(D
Q
01
?
Cj
^
1
€.
6
c
o
a.
°
£
5
5
O
£
>
O
1
0
«
D
H
c
CO
165
-------
Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are
required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party must be provided.
d. All applicable information which is on the product specific data submission must also be reported on the
CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet
for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered source products
must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for
the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported under column 10
and must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will
volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158.175
instructions. An explanation must be provided if the proposed limits are different than standard certified
limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs become obsolete for that
specific formulation.
166
-------
r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill In blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FiFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Ofler
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
167
-------
SEPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
OMt N*. 2070-0107
2070-0037
Approval Expire* 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, includina
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspectI of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch. PM-223. U.S. Environmental Protection Agency. 401 M St., S.W.. Washington. DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington. DC 20503.
Please fill In blanks below.
Company Numb«r
EFA t+g. No.
I Certify that:
1.
For each study cited in support of registration or ^registration under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
That for each study cited in support of registration or ^registration under FIFRA that is NOT an exclusive use
study, I am the original data submitter, or I have obtained the written permission of the original data submitter or I
have notified in writing the company(ies) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(C)(1)(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due. if any. The companies I have notified are: (check one)
I ] The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form.'
3. That I have previously complied with section 3(0(1 )(D) of FIFRA for the studies I have cited in support of
registration or reregistratten under FIFRA.
Signature
Nam* mid Till* (Pica** Typ* or Print)
Date
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to me
registration or reregistration of my products, to the extent required by FIFRA sections 3(O(1)(D) and 3(c)(2)(D).
Signature
Nam* and Tltl* (Pl*aa* Typ* or Print)
EPA Form M70.J1 (4-90)
-------
APPENDIX G. FACT SHEET
169
-------
170
-------
United States
Environmental Protection
Prevention. Pesticides
And Toxic Substances
EPA-738-F-94-026
September 1994
&ERA R.E.D. FACTS
Bentazon
Pesticide
Reregistration
Use Profile
Regulatory
History
All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered years ago be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency imposes any
regulatory controls that are needed to effectively manage each pesticide's risks.
EPA then reregisters pesticides that can be used without posing unreasonable
risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for reregistration
case 0182, bentazon, which includes bentazon technical and sodium bentazon,
the active ingredient in end-use pesticide products.
Bentazon, also known by its trade name Basagran, is a selective herbicide
that is used after seedlings have emerged to control broadleaf weeds and sedges
among food and feed crops including alfalfa, beans, corn, peanuts, peas,
peppers, peppermint, rice, sorghum, soybeans and spearmint. Bentazon also
is registered for use on ornamental lawns and turf. Most bentazon used in the
U.S. (73%) is applied to soybean crops.
Bentazon may be applied either aerially or using ground equipment
(except to lawns and turf, which may be treated using ground equipment only).
Formulations include a flowable concentrate and a soluble concentrate/liquid.
Use practice limitations prohibit applying bentazon through any type of
irrigation system; discharging effluent containing the product into sewage
systems or bodies of water; using treated plants for feed or forage; and treating
crops/sites within 30 to 75 days of harvest or 12 to 50 days of grazing.
EPA issued a Registration Standard for bentazon in September 1985
(NTIS #PB86-159563). An August 1990 Data Call-in (DCI) required
additional data on terrestrial and aquatic animal effects, environmental fate,
toxicology, residue chemistry, and plant protection. Products currently
registered contain bentazon alone or in combination with atrazine.
-------
Human Health Toxicity
AsS6SSm6nt Bentazon is slightly acutely toxic by the oral, dermal and inhalation
routes, and has been placed in Toxicity Category III (the second-to-lowest of
four categories) for these effects. It is a skin sensitizer in guinea pigs.
In a subchronic toxicity study using rats, bentazon caused a variety of
effects at the highest dose tested including reductions in body weight gain, an
increase in blood clotting times, and increased kidney and liver weights.
A chronic toxicity study in beagle dogs produced adverse effects at the
two highest dose levels including clinical signs of toxicity, anemia-like changes
in blood, depressed body weight gains, intestinal inflammation and congestion
of the small intestine and spleen.
In two combined chronic toxicity and carcinogenicity studies using rats
and mice, bentazon caused no compound-related increases in tumors.
Numerous other adverse effects were observed at the highest dose levels,
however, including effects on blood clotting and to the testes, pancreas and
liver, changes in kidney, thyroid and pituitary gland weights, reduced body
weight gain, and hemorrhage in the liver and heart. Based on these studies,
bentazon was classified as a "Group E" carcinogen, that is, a compound that
shows evidence of non-carcinogenicity for humans.
In a developmental toxicity study using rats, bentazon did not cause
maternal toxicity but at the highest dose tested caused an increase in
postimplantation loss and effects on bone development in fetuses. In rabbits,
bentazon caused some evidence of both maternal toxicity and developmental
toxicity. In a reproductive toxicity study using rats, at the highest dose levels,
bentazon caused a decrease in body weights of pups during lactation and
reductions in food consumption and weight gain, as well as kidney and liver
effects in parents. Bentazon is not mutagenic.
Dietary Exposure
People may be exposed to residues of bentazon through the diet.
Tolerances or maximum residue limits have been established for raw
agricultural commodities including various types of beans, corn, mint, peanuts,
peas, peppers, rice, sorghum and soybeans (please see 40 CFR 180.355(a));
for animal commodities including milk, eggs, and the fat, meat and meat
byproducts of cattle, goats, hogs, poultry and sheep (see 40 CFR 180.355(b);
and for the processed commodity spent mint hay (see 40 CFR 186.375). A
tolerance for rice hulls is proposed. EPA has reassessed the existing bentazon
tolerances and found that several changes and corrections are needed, as
explained in the RED document.
EPA has assessed the acute and chronic dietary risks posed by bentazon.
In the chronic risk analysis, the Agency used a Reference Dose (RfD), or
amount believed not to cause adverse effects if consumed daily over a 70-year
lifetime, of 0.03 mg/kg bwt/day (milligrams/kilogram of bodyweight/day).
This RfD is based on a No Observed Effects Level (NOEL) of 3.2 mg/kg
-------
bwt/day established in the dog feeding study described earlier, plus an
uncertainty factor of 100. For the overall U.S. population and 22 subgroups,
exposure from all current tolerances represents 2.2% of the RfD. The
exposure level of the most highly exposed subgroup, non-nursing infants less
than one year old, represents 8.1% of the RfD. Based on these estimates,
chronic dietary risk is not of concern.
In the acute dietary risk analysis, EPA used a NOEL derived from the
developmental toxicity study in rats, described earlier. The subgroup of most
interest in terms of developmental toxicity, females aged 13 and above (women
of child bearing age), have a margin of exposure (MOE) of 500. This means
they receive approximately 1/500* the amount that represents the NOEL in
animals. Thus, acute dietary risk from bentazon is not of concern.
Occupational and Residential Exposure
Based on current use patterns, workers may be exposed to bentazon
during and after applications in agricultural and other settings. The Agency
was concerned about developmental toxicity effects resulting from this
exposure. Margins of Exposure (MOEs) were estimated for short and
intermediate term exposure scenarios involving mixing, loading and applying
bentazon using both ground and aerial application methods. The resulting
MOEs ranged from 1,714 to 100,000; all are well over 100, the margin
regarded as acceptable from a safety standpoint. Therefore, the personal
protective equipment (PPE) required for early entry is the minimum PPE
required under the Worker Protection Standard (WPS): coveralls, chemical-
resistant gloves, shoes and socks.
The risk to homeowners who handle bentazon is expected to be lower
than that of people who handle the pesticide occupationally.
Human Risk Assessment
Bentazon is slightly acutely toxic by all routes (Toxicity Category III)
and is a skin sensitizer. It is classified as a "Group E" carcinogen—a chemical
showing evidence of non-carcinogenicity to humans, but causes some
developmental toxicity effects in rats and rabbits.
Bentazon is used on a variety of food crops, and people may be exposed
to residues through their diets. Based on EPA's acute and chronic dietary risk
assessments, however, dietary exposure to the bentazon uses supported for
reregistration is not of concern.
Although the Agency has concerns about possible developmental toxicity
effects among workers exposed to bentazon, these concerns are minor based
on our assessment that worker risks are low. There are no concern that
warrant the establishment of personal protective equipment (PPE) requirements
beyond those required by the Worker Protection Standard (WPS) or appearing
on existing product labels for non-WPS uses.
-------
Environmental Environmental Fate
AsSGSSITIGnt Dissipation of bentazon is dependent on microbe-induced degradation,
leaching and surface water runoff. Bentazon is moderately resistant to
degradation in aerobic mineral soils. Degradation in aquatic environments is
dependent on photolysis. Degradation in soil is controlled by processes
involving microbes in the presence of oxygen. Bentazon has a low binding
affinity to soil and therefore may leach into ground water and runoff into
surface waters. Leaching did not appear to be a major route of dissipation in
field studies, however. Bentazon dissipates rapidly under typical use
conditions.
The soil degradates of bentazon include AIBA, which is very mobile but
not persistent, and N-methylbentazon which is not mobile. These compounds
should not pose a threat to ground water.
Environmental Fate Assessment
EPA concludes that, in addition to surface runoff, leaching through the
soil profile also is a major route of dissipation for bentazon in the environment.
Bentazon exceeds levels of concern for ground water quality, and also may
impact the quality of surface water. Possible chronic effects of long-term
drinking water exposure prompted EPA's Office of Water to establish a
lifetime Health Advisory (HA) of 20 parts per billion (ppb), which will likely
be increased to 200 ppb soon. However, bentazon is not regulated under the
Safe Drinking Water Act (SDWA), no Maximum Contaminant Level (MCL)
has been established, and water supply systems are not required to sample or
analyze for its residues.
Bentazon has been detected in well water in four out of eight states
sampled including California (with the greatest number of detections, extending
over 11 counties), Florida, Missouri and Virginia. EPA is requiring a small-
scale prospective ground water monitoring study to establish the conditions
under which bentazon is prone to leach to ground water during normal
agricultural use. The Agency also is requiring a ground water label advisory
for bentazon to minimize its adverse effects on ground water. The registrant
has agreed to prepare educational materials for end users, dealers and
distributors regarding ground and surface water protection.
EPA also is requiring spray drift studies as confirmatory information,
and in the future may require drift-related labeling statements for bentazon
products applied aerially to agricultural crops.
Ecological Effects
Bentazon is slightly toxic to birds on an acute oral and subacute dietary
basis, and exceeds the level of concern for avian chronic effects. Bentazon is
slightly toxic to small mammals on an acute basis, and is practically nontoxic
to honeybees. Bentazon also is practically nontoxic to cold and warm water
fish, aquatic invertebrates and estuarine/marine organisms. Bentazon poses a
low risk to aquatic plants but may represent a hazard to terrestrial and semi-
aquatic plants.
-------
Additional Data
Required
Product Labeling
Changes Required
Ecological Effects Risk Assessment
EPA concludes that the use of bentazon as an herbicide will not pose a
serious environmental threat. Bentazon poses a chronic reproductive health
risk to birds. However, the registrant has agreed to lower the maximum
seasonal application rate from four to two pounds per acre, to reduce the
potential for this risk. Although it is slightly toxic to birds and small mammals
on an acute and subacute basis, bentazon is expected to pose minimal
acute/subacute risks to both endangered and nonendangered birds and mammals
as a result of its current uses. Since it is a herbicide, bentazon is expected to
pose a risk to non-target terrestrial and semi-aquatic plants near treated sites.
No hazard to aquatic animals or honeybees is anticipated.
EPA is requiring additional generic product chemistry, residue
chemistry, toxicology, environmental fate and ecological effects studies to
confirm its regulatory assessments and conclusions regarding bentazon. The
Agency also is requiring product-specific data including product chemistry and
acute toxicity studies, revised Confidential Statements of Formula (CSFs) and
revised labeling for reregistration.
All bentazon end-use products must comply with EPA's current pesticide
product labeling requirements. The following statements, some of which may
be on some existing product labels, are now required on all labels as specified
below.
Environmental Hazard Statement
Non-residential end-use product labeling must bear the following
statement for crayfish and catfish commercial farms:
"For terrestrial uses only, do not apply directly to water, or to areas
where surface water is present or to intertidal areas below the mean high
water mark. Do not contaminate water when disposing of equipment
washwater or rinsate."
Ground Water Label Advisory
To minimize bentazon contamination of ground water, the following
statement is required on all end-use product labeling:
"This chemical is known to leach through soil into groundwater under
certain conditions as a result of agricultural use. Use of this chemical in
areas where soils are permeable, particularly where the water table is
shallow, may result in ground water contamination."
Worker Protection Requirements
• The following entry restriction is required for all non-WPS occupational
uses of bentazon:
-------
"Do not enter or allow others to enter the treated area until sprays have
dried."
• The following entry restriction is required for all homeowner products:
"Do not allow persons or pets to enter the treated area until sprays have
dried."
• The following labeling statements are required for all bentazon products
intended primarily for occupational use, including uses both within and not in
the scope of the WPS.
Application Restrictions:
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may
be in the area during application."
Engineering Controls:
"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 Requirements:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If
there are no such instructions for washables, use detergent and hot water.
Keep and wash PPE separately from other laundry."
User Safety Recommendations:
"Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
"Users should remove clothing immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing."
"Users should remove PPE immediately after handling this product.
Wash the outside of gloves before removing. As soon as possible, wash
thoroughly and change into clean clothing."
• Because bentazon is a skin sensitizer, the following statement must be
placed in the "Hazards to Humans and Domestic Animals" section of the
Precautionary Statements on the labeling of all end-use products:
"This product may cause skin sensitization reactions in some people."
Reduction in Application Rate
All bentazon labels must be amended to reflect a maximum seasonal
application rate of 2 Ibs ai/a (2 pounds active ingredient per acre).
-------
Regulatory
Conclusion
For More
Information
Products Registered for Residential Use Only
The following label statement is required for all products intended for use
on lawns and turf:
"Do not apply directly to water. Do not contaminate water when
disposing of equipment washwater or rinsate."
The use of currently registered pesticide products containing bentazon in
accordance with approved labeling will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, all uses of these products are
eligible for reregistration.
Bentazon products will be reregistered once the required confirmatory
generic data, product-specific data, revised Confidential Statements of Formula
and revised labeling are received and accepted by EPA.
Products that contain the active ingredient atrazine in addition to
bentazon will be reregistered when atrazine also is eligible for reregistration.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for bentazon 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 bentazon 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
bentazon RED, or reregistration of individual products containing bentazon,
please contact the Special Review and Reregistration Division (7508W), OPP,
US EPA, Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides Telecommunications Network (NPTN). Call toll-free 1-
800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday through
Friday.
------- |