v>EPA
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA 738-R-97-007
June 1997
Re registration
Eligibility Decision (RED)
Pendimethalin
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W) .
EPA-738-F-97-007
June 1997
R.E.D. FACTS
Pendimethalin
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 before November 1, 1984, 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. To implement
provisions of the Food Quality Protection Act of 1996, EPA considers the
special sensitivity of infants and children to pesticides, as well as aggregate
exposure of the public to pesticide residues from all sources, and the
cumulative effects of pesticides and other compounds with common
mechanisms of toxicity. The Agency develops any mitigation measures or
regulatory controls needed to effectively reduce each pesticide's risks. EPA
then reregisters pesticides that meet the safety standard of the FQPA, and
can be used without posing unreasonable risks to human health or the
environment.
When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregistration case 0187, pendimethalin.
Pendimethalin is a selective herbicide used to control broadleaf weeds
and grassy weed species in a number of crop and noncrop areas and on
residential lawns and ornamentals. Formulations include liquid, solid,
granular, emsulsifiable concentrate, and dry flowables. Pendimethalin is
applied by broadcast, chemigation, conservation tillage, containerized plant
treatment, soil incorporation, and directed spray.
Pendimethalin was first registered as a pesticide in the U.S. in 1972.
EPA issued a Registration Standard for pendimethalin in March 1985
(PB86-172814). A October 1990 Data Call-In (DCI) required additional
product and residue chemistry, toxicology, ecological effects and
environmental fate data. Currently, 58 pendimethalin products are
registered.
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Human Health
Assessment
Toxicity
In studies using laboratory animals, pendimethalin generally has been
shown to be of low acute toxicity. It is slightly toxic by the oral and eye
route and has been placed in Toxicity Category III (the second lowest of
four categories) for these effects. It is practically non-toxic by the dermal
and inhalation routes and has been placed in Toxicity Category IV (the
lowest of four categories).
Dietary Exposure
People may be exposed to residues of pendimethalin through the diet.
Tolerances or maximum residue limits have been established for
pendimethalin (please see 40 CFR 180.361). EPA has reassessed the
pendimethalin tolerances and found that data for cotton gin by-products and
tobacco are required. The need for additional tolerances will be determined
upon receipt and evaluation of these data.
EPA has assessed the dietary risk posed by pendimethalin. For the
overall U.S. population, exposure from all current pendimethalin tolerances
represents less than 1% of the Reference Dose (RfD), or amount believed
not to cause adverse effects if consumed daily over a 70-year lifetime. The
exposure level of the most highly exposed subgroup, non-nursing infants,
represents less than 2% of the RfD. Actual risks using anticipated residue
information would be considerably less than 1% of the RfD for all
population subgroups. Therefore, it appears that chronic dietary risk is
minimal.
Occupational and Residential Exposure
Based on current use patterns, handlers (mixers, loaders, and
applicators) may be exposed to pendimethalin during and after normal use
of pendimethalin formulations.
Human Risk Assessment
Pendimethalin generally is of low acute toxicity, but causes thyroid
follicular cell adenomas in male and female rats and has been classified as a
Group C, possible human carcinogen. Many food and feed crops are
registered; however, dietary exposure to pendimethalin residues in foods is
extremely low, as is the cancer risk posed to the general population.
Of greater concern is the risk posed to occupational handlers involved
in food, feed, fiber, ornamental, turf, rights-of-way and other noncrop
treatments; and homeowner handlers making applications to residential turf.
Occupational/Short and Intermediate Term:
Agency calculations indicate that Margins of Exposure (MOEs) for
handlers wearing baseline attire (long-sleeve shirt, long pants, shoes and
socks) are acceptable (over 100) for all but three scenarios: (1)
mixing/loading liquid for aerial applications and irrigation systems, (2)
mixing/loading liquid for rights-of-way spraying, and (3) mixing/loading
liquid for groundboom applications. These MOEs range from 1.5 to 59.
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The risks to handlers in these scenarios are reduced to an adequate level
(MOEs range from 110 to 33,333) when chemical-resistant gloves are
added to the baseline attire.
Occupational/Post Application:
The Agency has determined that there are risks following
applications to commercial or research food, feed, fiber, turf, and
ornamental crops. Restricted Entry Intervals ( REIs) can allow sufficient
time to pass for residues to dissipate to levels that result in adequate MOEs.
Pending the development of pendimethalin specific data, the Agency is
requiring that the 12-hour interim REI be increased to 24 hours for all
pendimethalin uses within the scope of the Worker Protection Standard
(WPS).
However, REIs are generally not feasible as a mitigation measure for
occupational exposures in noncrop areas (such as rights-of-way).
Therefore, as a risk mitigation measure, the Agency is requiring a reduction
in the maximum use rate from 3 Ibs active ingredient(ai)/acre to 2 Ibs.
ai/acre. The registrant agreed to this reduction in the maximum application
rate.
Residential/Post Application:
Again, REIs are not practical or feasible for residential or recreational
turf; consequently, the Agency is requiring a reduction in the maximum use
rate to 2 Ibs. ai/acre.
FQPA Considerations
EPA has determined that the established tolerances with amendments
and changes as specified in this document, meet the FQPA safety standard
for the general population. In reaching this determination, EPA has
considered the available information on aggregate exposures (both acute
and chronic) from non-occupational sources, food and drinking water.
Pendimethalin has both food and non-occupational uses; therefore,
the considerations for aggregate exposure are those from food, drinking
water, and residential non-occupational sources.
Chronic dietary risks utilizing tolerance level residues and 100% crop
treated (TMRC) are <1% of the RfD for the general population.
Based on limited ground water monitoring data (data from 8 states
with 2 states with detectable residues), the maximum level found was 0.9
ppb. The maximum level of pendimethalin found in surface water is 17.6
ppb. Based on this information, the estimated risks from water are <2%
RfD for all population subgroups, including those most highly exposed to
pendimethalin residues.
In evaluating the potential for cumulative effects, EPA does not have,
at this time, available data to determine whether pendimethalin has a
common mechanism of toxicity with other substances or how to include this
pesticide in a cumulative risk assessment. Unlike other pesticides for which
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Environmental
Assessment
EPA has followed a cumulative risk approach based on common
mechanism of toxicity, pendimethalin does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that pendimethalin has a common
mechanism of toxicity with other pesticides.
Environmental Risk Characterization
Pendimethalin dissipates in the environment by binding to soil,
microbially-mediated metabolism and volatilization. It is essentially
immobile in soil.
Based on laboratory studies and limited field study information,
pendimethalin is slightly to moderately persistent in aerobic soil
environments. Persistence decreases with increased temperature, increased
moisture and decreased soil organic carbon.
Additional terrestrial field dissipation studies for major pendimethalin
uses (cotton and soybeans) are requested to fully characterize the fate of
pendimethalin.
Pendimethalin may contaminate surface water from spray drift
associated with aerial and ground spray application, or in runoff from
rainfall events and through irrigation waters (chemigation). However, its
high affinity to bind to soil and sediment particles should limit
concentrations of pendimethalin in surface waters.
Although pendimethalin has been detected in ground water (at very
low levels), the potential for ground water contamination from
pendimethalin residues is low.
Pendimethalin would not represent a high acute risk to birds or a high
acute or chronic risk to mammals. The chronic risk to birds could not be
determined because avian reproduction studies have not been submitted.
These studies are required.
Chronic risk Levels of Concern (LOCs) for fish were exceeded by a
small margin. But it is presumed that overall, pendimethalin does not
represent a high risk to aquatic animals and plants, including estuarine
organisms.
The use of pendimethalin may adversely effect endangered species of
terrestrial and semi-aquatic plants, aquatic plants and invertebrates
including mollusks, fish, and birds (specifically grazers).
The risk to nontarget terrestrial and semi-aquatic plants is expected to
be moderate.
Risk Mitigation To lessen the risks posed by pendimethalin, EPA is requiring the following
risk mitigation measures:
For occupational handlers/use sites:
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Additional Data
Required
Product Labeling
Changes
Required
o increase restricted entry interval from 12 to 24 hours;
ฐ add chemical resistant gloves;
o engineering controls-all WP formulations must be contained in water-
soluble packaging.
For residential lawns and sod farm use sites:
ฐ reduce maximum application rate from 3 Ibs. ai/acre to 2 Ibs. ai/acre for
residential and sod farm use sites
To reduce risks to nontarget plants:
o Add spray drift best management practices.
EPA is requiring the following additional generic studies for
pendimethalin to confirm its regulatory assessments and conclusions: post
application reentry studies (guidelines 132-la, b), physical/chemical
properties for the 86.8% and 60% FIs (61-1 through 61-3, 62-2, 62-3),
magnitude of residue for tobacco and cotton gin byproducts (171-4k),
processing for rice (171-41), avian chronic (71-4), field dissipation for
cotton and soybeans (164-1), and aquatic dissipation for rice (164-2).
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 pendimethalin end-use products must comply with EPA's current
pesticide product labeling requirements and with the following. For a
comprehensive list of labeling requirements, please see the pendimethalin
RED document.
The Agency is establishing minimum (baseline) engineering controls
for occupational uses of pendimethalin end-use products formulated as
wettable powders. All wettable powder formulations must be contained in
water-soluble packaging.
Products Intended for Occupational Use- WPS Uses
The minimum (baseline) PPE for occupational uses of pendimethalin end-
use products are:
For emulsifiable concentrate formulations:
Mixers and loaders must wear:
long-sleeved shirt and long pants,
chemical-resistant gloves, and
shoes plus socks
For water-dispersible granule, wettable powder, and
emulsifiable concentrate formulations whose use directions
reasonably permit application using hand-held sprayers:
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Commercial Handlers (mixers, loaders, and applicators) who apply
this product using hand-held equipment or hoses (not including hoses
attached to truck-mounted equipment) must wear:
~ long-sleeved shirt and long pants,
~ chemical-resistant gloves, and
~ shoes plus socks
Restricted-entry interval:
A 24-hour restricted-entry interval (REI) is required for uses on
food, feed, fiber, ornamental, forestry, and turf crops within the scope
of the WPS on all pendimethalin end-use products.
Exception: if the product is soil-injected or soil-incorporated, the
Worker Protection Standard, under certain circumstances, allows
workers to enter the treated area if there will be no contact with
anything that has been treated.
The labels of all pendimethalin end-use products must be
revised to bear the following application rate for the respective uses:
For residential lawn and sod farm uses:
"Maximum application rate of 2.0 Ibs. active ingredient per
acre."
NonWPS uses
For liquid applications:
"Do not enter or allow others to enter the treated area until sprays
have dried."
For dry applications:
"Do not enter or allow others to enter the treated area until dusts have
settled."
Products Intended Primarily for Homeowner Use
Entry restrictions:
The Agency is establishing the following entry restrictions for
all homeowner uses of pendimethalin end-use products (NOTE: This
presumes the registrant reduces the maximum application rate for turf
at residential sites and parks and recreation areas to two pounds active
ingredient per acre.):
For liquid applications:
"Do not allow people or pets to touch treated plants until the sprays
have dried."
For dry applications:
"Do not allow people or pets to enter the treated area until dusts have
settled."
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Products Intended Primarily for Occupational Use
The Agency is requiring the following labeling statements to be
located on all end-use products containing pendimethalin that are
intended primarily for occupational use.
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."
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."
Products Intended Primarily for Home Use
Application Restrictions
"Do not apply this product in a way that will contact any person or
pet, either directly or through drift. Keep people and pets out of the
area during application."
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."
Environmental Hazards Statement
"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
wash waters."
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Regulatory
Conclusion
For More
Information
Application Rates
The labels of all pendimethalin end-use products must be revised to
bear the following application rate for the respective uses:
For residential lawn and sod farm uses:
"Maximum application rate of 2.0 Ibs. active ingredient per acre."
Spray Drift
A spray drift labeling advisory is required for labels of all products
that can be applied aerially.
The use of currently registered products containing pendimethalin 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.
Pendimethalin products will be reregistered once the required
product-specific data, revised Confidential Statements of Formula, and
revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for pendimethalin during a 60-day time period,
as announced in a Notice of Availability published in the Federal Register.
To obtain a copy of the RED document or to submit written comments,
please contact the Pesticide Docket, Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone 703-305-
5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System
at 703-308-7224. They also are available on the Internet using ftp on
FTP.EPA.GOV, or using WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-2419, telephone 1-
800-490-9198, fax 513-489-8695.
Following the comment period, the pendimethalin RED document
also 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 pendimethalin RED, or reregistration of individual products containing
pendimethalin, please contact the Special Review and Reregistration
Division (7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.
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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 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
3Q mi
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case pendimethalin
which includes the active ingredient pendimethalin. The enclosed Reregistration Eligibility
Decision (RED) contains the Agency's evaluation of the data base of these chemicals, 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 may also include 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 is due 90 days from
the receipt of this letter. The second set of required responses is 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 arid Reregistration Division representative
Jane Mitchell (703) 308-8061. Address any questions on required generic data to the Special
Review and Reregistration Division representative Jane Mitchell, (703) 308-8061.
Sincerely yours,
Enclosures
Lois Rossi, Director
Special Review
and Reregistration Division
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, a DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms). You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
may be suspended.
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 time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response. 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, but are not
required to, 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).
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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 ง158.175) 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 ง158.175(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 NQTICE-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 REVEEWS-EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
PENDIMETHALIN
LIST A
CASE 0187
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
PENDIMETHALIN REREGISTRATION ELIGIBILITY DECISION TEAM i
ABSTRACT .' v
I. INTRODUCTION 1
II. CASE OVERVIEW 3
A. Chemical Overview 3
B. Use Profile 3
C. Estimated Usage of Pesticide 5
D. Data Requirements 7
E. Regulatory History 8
HI. SCIENCE ASSESSMENT 8
A. Physical Chemistry Assessment 8
1. Description of Chemical 8
2. Identification of Active Ingredient 9
3. Manufacturing-Use Products 9
4. Regulatory Background 9
B. Human Health Assessment 9
1. Toxicology Assessment 9
a. Acute Toxicity 9
b. Subchronic Toxicity 10
c. Chronic Toxicity/Carcinogenicity 14
d. Developmental Toxicity 15
e. Reproductive Toxicity 16
f. Mutagenicity 17
g. Metabolism ... 21
h. Toxicological Endpoints of Concern Used in Risk
Assessment 21
i. Incident Reports 25
2. Exposure Assessment 25
a. Dietary Exposure 26
b. Occupational and Residential Exposure : 30
3. Risk Characterization 37
a. Dietary 37
b. Occupational and Residential 39
4. Food Quality Act Considerations Regarding Pendimethalin.... 47
a. Potential Risks to Infants and Children 47
b. Aggregate Exposure/Risk 49
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c. Cumulative Effects 51
C. Environmental Assessment 53
1. Ecological Toxicity Data 53
a. Toxicity to Terrestrial Animals . 53
b. Toxicity to Aquatic Animals 54
c. Toxicity to Plants 58
2. Environmental Fate 60
a. Environmental Fate Assessment 60
b. Environmental Fate and Transport 61
c. Water Resources 69
3. Exposure and Risk Characterization 72
a. Ecological Exposure and Risk Characterization 72
b. Environmental Risk Characterization 86
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 92
A. Determination of Eligibility . . 92
B. Determination of Eligibility Decision 92
1. Eligibility Decision 92
2. Eligible and Ineligible Uses 93
C. Regulatory Position : 93
1. Food Quality Protection Act Findings 93
2. Tolerance Reassessment 95
3. Codex Harmonization 98
4. Summary of Risk Management Decisions 98
a. Human Health 98
(1) Acute Dietary 98
(2) Chronic Dietary 98
(3) Short and Intermediate Term Occupational
and Residential 99
b. Environmental 100
(1) Avian 100
(2) Mammals 100
(3) Fish 100
(4) Nontarget Plants (Terrestrial and Semi-Aquatic). 100
(5) Endangered Species 100
5. Labeling Rationale 101
6. Spray Drift Advisory 106
7. Environmental Hazards Statement 106
V. ACTIONS REQUIRED OF REGISTRANTS 106
A. Manufacturing-Use Products 106
1. Additional Generic Data Requirements 106
2. Labeling Requirements for Manufacturing-Use Products 108
B. End-Use Products 109
1. Additional Product-Specific Data Requirements 109
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2. Labeling Requirements for End-Use Products 109
a. Occupational/Residential 109
b. Environmental Hazards Statement 114
c. Application Rates 114
C. Spray Drift Labeling 115
D. Existing Stocks 117
VI. APPENDICES 119
APPENDIX A. Table of Use Patterns Subject to Reregistration 121
APPENDIX B. Table of the Generic Data Requirements and Studies
Used to Make the Reregistration Decision 122
APPENDIX C.Citations Considered to be Part of the Data Base Supporting
the Reregistration of Pendimethalin 141
APPENDIX D. Combined Generic and Product Specific Data Call-In . . 175
Attachment 1. Chemical Status Sheets 195
Attachment 2. Combined Generic and Product Specific Data
Call-In Response Forms (Form A inserts) Plus Instructions ... 197
Attachment 3. Generic and Product Specific Requirement Status
and Registrant's Response Forms (Form B inserts) and
Instructions 201
Attachment 4. EPA Batching of End-Use Products for Meeting
Data Requirements for Reregistration 208
Attachment 5. List of All Registrants Sent This Data Call-In
(insert) Notice 215
Attachment 6. Cost Share, Data Compensation Forms,
Confidential Statement of Formula Form and Instructions. . . . 217
APPENDIX E. List of Available Related Documents 225
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PENDIMETHALIN REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
James G. Salmon
Stephen M. Jarboe
Jihad A. Alsadek
Biological Analysis Branch
LUIS
Economic Analysis Branch
Environmental Fate and Effects Risk Assessment
Betsy Grim
Daniel D. Rieder
James Breithaupt
Renee Costello
Health Effects Risk Assessment
Mary Clock
Richard Griffin
Marion Copley
William B. Greear
John Leahy
Bonnie Cropp-Kohlligian
Registration Support Risk Assessment
Larry Fried
Edward Allen
Risk Management
Jane D. Mitchell
Andy Ertman
Environmental Risk Characterization Branch
Environmental Risk Characterization Branch
Environmental Risk Characterization Branch
Environmental Risk Characterization Branch
Risk Characterization and Analysis Branch
Risk Characterization and Analysis Branch
Toxicology Branch I
Toxicology Branch I
Occupational and Residential Exposure Branch
Reregistration Support Chemistry Branch
Registration Support Branch
Fungicide-Herbicide Branch
Reregistration Branch
Reregistration Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
DRES Dietary Risk Evaluation System
D WEL Drinking Water Equivalent Level (DWEL) The D WEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO/WHO Food and Agriculture Organization/World Health Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HDT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 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 i s
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LD,0 Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOC Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulat e
contaminants in drinking water under the Safe Drinking Water Act.
ug/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEC
NPDE.S
NOEL
NOAEL
OP
OPP
Pa
PADI
PAG
PAM
PHED
PHI
ppb
PPE
ppm
PRN *
Q",
RBC
RED
REI
RfD
RS
RUP
SLN
TC
TD "
TEP
TC5AI
TLC
TMRC
torr
WP
WPS
No effect concentration
National Pollutant Discharge Elimination System
No Observed Effect Level
No Observed Adverse Effect Level
Organophosphate
Office of Pesticide Programs
pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
Provisional Acceptable Daily Intake
Pesticide Assessment Guideline
Pesticide Analytical Method
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Pesticide Registration Notice
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
Red Blood Cell
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Registration Standard
Restricted Use Pesticide
Special Local Need (Registrations Under Section 24 (c) of FIFRA)
Toxic Concentration. The concentration at which a substance produces a toxic effect.
Toxic Dose. The dose at which a substance produces a toxic effect.
Typical End-Use Product
Technical Grade Active Ingredient
Thin Layer Chromatography
Theoretical Maximum Residue Contribution
A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
Micrograms per liter
Wettable Powder
Worker Protection Standard
IV
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ABSTRACT
The U. S. Environmental Protection Agency has completed its reregistration eligibility
decision of the pesticide pendimethalin, N-(l-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzeneamine. This decision includes a comprehensive reassessment of the required
target data base and the use patterns of currently registered products. On August 3, 1996, the
President signed the "Food Quality Protection Act of 1996" (FQPA) which amended the
Federal Food, Drug, and Cosmetics Act and the Federal Insecticide, Fungicide and
Rodenticide Act. These two Federal statutes provide the framework for pesticide regulation
in the United States. FQPA became effective immediately upon signature and all
reregistration eligibility decisions (RED) signed subsequent to August 3rd are accordingly
being evaluated under the new standards imposed by FQPA.
Pendimethalin is a selective herbicide used on various agricultural and non-agricultural
sites to control broadleaf weeds and grassy weed species in crop and noncrop areas. It is
applied to soil preplant, preemergence, and postemergence, (including layby) with ground and
aerial equipment.
In establishing or reassessing tolerances, FQPA requires the Agency to consider
aggregate exposures to pesticide residues, including all anticipated dietary exposures and
other exposures for which there is reliable information, as well as the potential for cumulative
effect from a pesticide and other compounds with a common mechanism of toxicity. The Act
further directs EPA to consider potential for increased susceptibility of infants and children to
the toxic effects of pesticide residue. The Agency considered the appropriateness of an
additional uncertainty factor, which can be applied in situations where available data indicate
infants and children may have an increased sensitivity to the'pesticide. In general, the data
base for pendimethalin does not indicate a potential for increased toxicological sensitivity
from either pre- or post-natal exposures. No developmental toxicity was observed in either
the rat or rabbit developmental toxicity studies, nor was there evidence in the two-generation
reproduction study of developmental or reproductive toxicity at dose levels below those in
which parental toxicity was observed. Therefore, the Agency has determined that an
additional uncertainty factor is not warranted.
Regarding aggregate risks, the Agency considered chronic exposure through the diet,
including drinking water, and short term exposure through residential uses. The estimated
aggregate risks from these exposures do not exceed the Agency's levels of concern. EPA
does not have, at this time, available data to determine whether pendimethalin has a common
mechanism of toxicity with other substances or how to include this pesticide in a cumulative
risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk
approach based on common mechanism of toxicity, pendimethalin does not appear to produce
a toxic metabolite produced by other substances. For the purposes of this tolerance action,
therefore, EPA has not assumed that pendimethalin has a common mechanism of toxicity with
other substances.
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-------
The Agency has concluded that all uses, as prescribed in this document, will not cause
unreasonable risks to humans or the environment and therefore, all products are eligible for
reregistration. To mitigate risks of exposure to occupational/residential handlers and children,
the Agency is requiring, among other changes, reduction in the maximum application rate for
residential and recreation area turf, the use of personal protective equipment, and longer '
restricted-entry intervals. Additional data for product chemistry, residue chemistry,
environmental fate, and occupational/residential exposure are being required to confirm the
Agency's risk assessment and cdnclusions.
Before reregistering the products containing pendimethalin, 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 FBFRA, the Agency will reregister a product. Those products which contain other
active ingredients will be eligible for reregistration only when the other active ingredients are
determined to be eligible for reregistration.
VI1
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-------
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 reregistration process to be
completed in nine years. There are five phases to the reregi stration process. The first four .
phases of the process focus on identification of data requirements to support the reregi stration
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 reregi strati on.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" 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.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law
104-170) was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S. C. 136 et seq. The FQPA amendments went into effect immediately. Asa
result, EPA.is embarking on an intensive process, including consultation with registrants,
States, and other interested stakeholders, to make decisions on the new policies and
procedures that will be appropriate as a result of enactment of the FQPA. This process will
include a more in depth analysis of the new safety standard and how it should be applied to
both food and non-food pesticide applications. The FQPA did not, however, amend any of
the existing reregistration deadlines in section 4 of FIFRA. The Agency will therefore
continue its ongoing reregistration program while it continues to determine how best to
implement FQPA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of pendimethalin including the risk to infants and children for any potential
dietary, drinking water, dermal or oral exposures, as stipulated under the FQPA. The
document consists of six sections. Section I is the introduction. Section II describes
pendimethalin, 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 pendimethalin. Section V discusses the
reregistration requirements for pendimethalin. Finally, Section VI is the Appendices which
support this Reregistration Eligibility Decision. Additional details concerning the Agency's
review of applicable data are available on request.
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-------
II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregi strati on Eligibility
Decision:
B.
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Trade and Other Names:
Basic Manufacturer:
Use Profile
Pendimethalin
[n-(l-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine)
Dinitroaniline
40487-42-1
108501
C13H19N304
Prowl, Squadron
American Cyanamid
The following is information on the currently registered uses with an overview
of use sites and application methods. A detailed table of these uses of pendimethalin
is in Appendix A.
For:
Pendimethalin
Type of Pesticide: Herbicide
Mode of Action: A micro tubule disruptor
Use Sites:
Terrestrial food crop: apricot, carrot (including tops), cherry, fig, garbanzos
(including chick peas), garlic, nectarine, olive, onion, peach, pear, pecan,
pistachio, plum, prune, shallot, walnut (English/black)
Terrestrial food+feed crop: almond, apple, beans, dried-type,beans, succulent
(lima), beans, succulent (snap), citrus fruits, corn, field, corn, sweet, cotton,
-------
cowpea/blackeyed pea, garbanzos (including chick peas), grapes, peanuts,
peas, potato, (white/Irish), rice, sorghum, soybeans, sugarcane, sunflower
Terrestrial feed crop: alfalfa, lupine, small seeded legumes
Terrestrial non-food crop: Christmas tree plantations, commercial/industrial
lawns, golf course turf, industrial areas (outdoor), jojoba, nonagricultural
outdoor buildings/structures, ornamental and/or shade trees, ornamental
herbaceous plants, ornamental lawns and turf, ornamental nonflowering plants,
ornamental sod farm (turf), ornamental woody shrubs and vines, paths/patios,
recreation area lawns, tobacco
Terrestrial non-food+outdoor residential: nonagri cultural
rights-of-way/fencerows/hedgerows, ornamental and/or shade trees, ornamental
ground cover, ornamental lawns and turf, ornamental woody shrubs and vines,
paved areas (private roads/sidewalks), residential lawns
Aquatic food: rice
Target pests: barnyardgrass; bluegrass, annual; buffalograss; buttonweed;
carpetweed; chickweed, common; chickweed, mouseear; clover, hop; corn
speedwell; crabgrass; crowfootgrass; cudweed; dodder; eveningprimrose;
fiddleneck; field sandbur; filaree; florida pusley; foxtail, giant; foxtail, green;
foxtail, yellow; goosegrass; henbit; johnsongrass (seedling); junglerice;
knotweed, prostrate; kochia; lamb squatters; london rocket; lovegrass; millet,
wild proso; oxalis; panicum, browntop; panicum, fall; panicum, Texas;
pigweed; pigweed, redroot; puncturevine; purslane; red rice; shattercane;
shepherdspurse; signalgrass; signalgrass, broadleaf; smartweed, Pennsylvania;
sprangletop; sprangletop, mexican; sprangletop, red; spurge, annual; spurge,
prostrate; stinging nettle; swollen fmgergrass; velvetleaf; witchgrass;
woodsorrel, yellow; wooly cupgrass
4.
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Formulation types registered: technical grade active ingredient liquid
Manufacturing product
Liquid
Solid
End use product
Emulsifiable concentrate
Liquid
Granular
Soluble concentrate/liquid
Water dispersible granules
(Dry flowable)
Wettable powder
90.0%
60.0%
86.8%
21.9 to 42.3%
34.4%
0.7 to 2.0%
22.0%
Up to 60.0%
50.0%
Methods and Rates - (Please refer to LUIS Report Appendix A.)
Types of treatment
Broadcast; chemigatidn; Conservation tillage; Containerized plant treatment;
Directed spray; Soil incorporated treatment; Soil treatment; Spray
Equipment - Aircraft; Backpack sprayer; Boom sprayer;Center pivot irrigation;
Hand move irrigation;Low pressure ground sprayer; Low pressure hand wand;
Low volume sprayer; Moving wheel irrigation; Solid set irrigation; Sprayer;
Spreader.
Timing -Bulbs; Dormant; Early fall; Early postemergence; Early preplant; Fall;
Foliar; Late fall; Late summer; Layby; Nonbearing; Nurserystock;
Postemergence} Postplant; Posttransplant; Preemergence; Preplant; Ratoon;
. Seed bed; Spring; Summer; When needed.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
pendimethalin These estimates are derived from a variety of published and
proprietary sources available to the Agency. The data, reported on an aggregate and
site (crop) basis, reflect annual fluctuations in use patterns as well as the variability in
using data from various information sources.
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The table below summarizes the pesticide use by site.
Quantitative Usage Analysis for' Pendimethalin '
(March 1997)
Acres % Acres Treated
Cl'ti],i/Sit<- Grgwn Average Maximum
Likely
(000)
Agriculture
Alfalfa
1.3
Alnv im;Is
1.0
1.1
Etotins/Pftas (Green)
1.0
Bwans/feas' (dry)
1.0
Citrus, Others2
1.0
Cule crops
1.0
Corn
1.0
Cottun
1.1
Cucurbits
1 .1
Harlie
1.0
ซtrap*f ruit
1.3
1.0
ldlซ I'i'op land
1.0
Mfeiuns, All
1.5
Mint
unions
Uramjfts
1.0
1.0
1.1
1.0
Riซ'*
1.1
Surghum
24,276
390
503
690
2,052
70
283
78,156
11,121
' 233
25
176
817
7,395
383
154
152
571
186
1,651
1,326
3,130
12,183
0.3
1.0
0.1
6.8
3.7
0.3
0.7
4.7
35.0
0.9
60.0
2.0
0.6
0.1
3.1
12.0'
25.0
0.8
0.4
35.0
18.0
9.0
0.2
0.5
2.0
0.6
8.0
4.7
1.4
2.5
5.0
50.0
1.7
70.0
3.5
1.2
0.2
7.6
15.0
35.0
1.2
1.1
40.0
24.0
13.0
0.7
Acres Treated Lbs AI
Average Maxinjum Average Maximum
Likely Likely
(000) (000) (000) (000)
72.8
3.9
0.5
47.2
75.9
0.2
2.0
3,700.0
3, 900.0
2.1
15.0
3.5
4.9
7.4
11.7
18.5
38.0
4'. 6
0.7
577.9
238.7
281.7
24.4
121.4
7.8
3.0
55.4
96.6
1.0
7.1
3,900.0
5,550.0
4.0
17.5
6.2
9.8
14.8
29.2
23.1
53.2
6.9
2.0
660.4
318.2
406.9
85.3
150 .
6
1
45
66
0.25
1.6-
4,000
3,000
2.8
15
6.6
5
6
10
40
100
6
0.6
550
235
300
23
250
13
2
65
70
3
7
4,900
3,800
5
16
15
10
15
30
45
130
9
2
650
275
350
39
Rate
(Lbs AI)
1.6
1.5
1.5
1.0
0.9
1.3
0.8
1.1
0.7
1.2
1.0
1.5
1.0
0.8
0.6
1.4
1.4
1,3
0.9
0.9
1.0
1.0
0.9
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1.0
Soybeans
1.0 ' ' '
'Sugarcane
1.0
Sunflowers
1.0
Sweet corn
'l.p
Tobacco
1.0 ,
Vegetables, Other3
1.0 ' . ' i
Walnuts
1.0 .
Turf Farms4
Horticulture''
TOTAL AGRICULTURE
Non-Agriculture 4
Golf Courses
Lawn '
Landscape
TOTAL (LBS..A.-I.)
58,414 . ' ' 26.0.
857 . '29. '2
. 2,044 ' -19.0
.' 761 6.0
785' ' 43.0'' '
. 110 0.9
. 184' '-.'-0-.3
225
.. .430 . .
(LBS. A.I.) '";-.
, 1,-550
33/000
19,000.
. -30.0 15',200..0 ' 17,525.0 13,700,'
' '40.1 250.0 ' 350.0 350
21.0 388.4' 429.2' ,.400 '
8.0 45.7 60.9 ' 42
._'. 55.0 ' 337.6 431.8 ' ;300
. 5.6 ' 1,0 5.0 I'.O
1.1 -0.6 2.0 ' i
' ,
~ ' , 37
34
' ' .''. 23,4.36
'
' . ' . 263- .
1,886 .
108 .
' . 25,-692
15,000 0.9
.575 1.4"
500 1.0 .'
.. 67 - -0.9
395 0.9 ,'.
-
1 1.3
3 1.7
45
40'
27,333
335 :
. 2400
130
30,198
Note: '.' ' ' -
!. The estimate's might not exactly.correspond ;because pf rounding.
The table shows that the average annual domestic pendimethalin usage on the different agricultural
crops ranges from 23 to-''27 million pounds of active ingredient.. Between. 2 and 3 million-pounds of
this chemical -are,used on non-agricultural sites (84 percent on lawns).. The highest usage sites for
this herbicide are soybeans, corn, cotton, peanuts, sunflower, sugarcane, rice, tobacco/ and potatoes.
2. Citrus other includes tangelos, tangerine, 'kumquats, and limes.
3. Vegetables other includes artichoke, asparagus/ okra, oriental vegetables, and.rhubarb.
A. Percentage crop treated, application1 rates and number of applications are not available for'turf,
horticulture, and non-agricultural sites. . . ' .
Pears, -seed crops,, tomatoes, and wheat (spring and winter) 'are covered by the data, but they .show one
percent or less of the acres treated'with pendimethalin. . ' .
Reference: Pesticide'usage estimates, different USDA and EPA data sources including foreign usage
data. ' . ' ' ... -
D. Data Requirements
Data requested ih the March 1985 Registration Standard for pendimethalin include
studies on product chemistry, ecological effects, environmental fate, and residue
chemistry. These data were required to support the uses listed in the Registration Standard.
A Data Call-in Notice was issued,October 1.990 requiring.additional data on product
chemistry, residue chemistry, toxicology, ecological effects and environmental fate.
Appendix B includes all data'requirements identified by the Agency for currently registered
uses needed to support ^registration.
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E. Regulatory History
Pendimethalin was patented by American Cyanamid in 1972 and first
registered in the United States in 1974. Pendimethalin is a dinitroaniline herbicide which
selectively controls certain broadleaf weeds and grassy weed species in certain crop and
noncrop areas. It is applied to soil preplant, preemergence, and postemergence, (including
layby) with ground and aerial equipment. A Registration Standard was issued in March 1985.
Additional data were required in a Data Call-In Notice issued in October 1990. This
Reregi strati on Eligibility Decision Document reflects a reassessment of all data which were
submitted in response to the Registration Standard and the subsequent Data Call-In Notice.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
All pertinent data requirements are satisfied for the 90% Technical (T) and the
pendimethalin TGAI; however, additional product-specific data (physical/chemical
properties) are outstanding for the 86.8% and 60% Formulating Intermediaries (FIs). The
registrant must submit the data required in the attached data summary tables for the 86.8%
and the 60% FIs, and either certify that the suppliers of beginning materials and the
manufacturing processes for the pendimethalin technical product and manufacturing products
(MPs) have not changed since the last comprehensive product chemistry review or submits
complete updated product chemistry data packages.
1. Description of Chemical
Pendimethalin [N-(l-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] is a selective
herbicide registered for control of broadleaf weeds and grassy weed species.
Empirical Formula: Ci3H19N3O4
Molecular Weight: 281.3
CAS Registry No.: 40487-42-1
Chemical Code: 108501
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2. Identification of Active Ingredient
Pendimethalin is an orange-yellow crystalline solid with a melting point of 54-58ฐ C.
It is soluble in chlorinated hydrocarbons and aromatic solvents such as methylene chloride,
acetone, and xylene, but only soluble in water at <0.5 ppm at 20ฐ C. Pendimethalin is stable
under acidic and alkaline conditions.
3. Manufacturing-Use Products
There are three pendimethalin manufacturing-use products (MPs) registered to
American Cyanamid Company under Chemical Code 108501: the 90% technical (T);( EPA
Reg. No. 241-245), and the 86.8% and 60% formulation intermediates (FIs); (EPA Reg. Nos.
241-291 and 241-281), respectively.
4. Regulatory Background
The Pendimethalin Reregi strati on Standard dated 7/20/84 and Guidance Document
dated 3/85 required additional data for the American Cyanamid 90% T. The Pendimethalin
Reregi strati on Standard Update review dated 3/19/90 required additional data concerning
Guidelines 62-2 and 62-3 for the 90% T.
In addition, because pendimethalin contains dinitroanilines, a discussion of the
potential for formation of nitrosamines and analysis of the 90% T for the presence of
nitrosamines formed during manufacture and storage of the product was required. Submitted
data indicate that no volatile nitrosamines are present (<0.5 ppm) and that total nonvolatile
nitrosamines are present at less than 100 ppm.
Refer to the Generic Data Call-in Notice for the outstanding product chemistry data
requirements for the 90% technical, the 86.8% and 60% formulation intermediates.
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base is adequate and will support reregi strati on
eligibility. There are no data gaps at this time.
a. Acute Toxicity
The table below summarizes the results of acute toxicity studies
on pendimethalin and the toxicity categories for the different routes of
administration:
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Table 1. Acute Toxicity Values of Technical Pendimethalin
TEST
Oral LD50 in rat
(MRID 00026657)
Dermal LD50 in rabbit
(MRID 00026657)
Inhalation LC50 in rat
(MRID 00073342)
Eye irritation in rabbit
(MRID 00026657)
Dermal irritation in rabbit
(MRID 00026657)
Dermal sensitization
^MRID 00 153767)
RESULT
LD50(M) = 1250 mg/kg
LDsn(F)= 1050 mg/kg
LD50 > 5000 mg/kg
LC50 > 320 mg/L (nominal
concentration)
Slight conjunctival irritation
No irritation
Nonsensitizing
CATEGORY
III
IV
IV
III
IV
N/A
b. Subchronic Toxicity
Feeding Studies in Rats: In a 30-day feeding study in rats (MRID
000106754), pendimethalin technical (98.7%) was administered to
groups of 10 males and 10 females RH Wistar rats in the diet at levels of
0, 800, 1,600 or 3,200 ppm (corresponding to 0, 80, 160, or 320
mg/kg/day). Urine was darker than controls in the 1,600 and 3,200 ppm
groups. At 3,200 ppm there appeared to be increased liver weight The
LOEL is 3,200 ppm (320 mg/kg/day) based on increased liver
weight. The NOEL is 1,600 ppm (160 mg/kg/day).Although this
study is classified as Supplementary it provides useful information.
In a 13-week feeding study in rats (MRID 00156081), AC
92,553 (pendimethalin, 92.1%, Lot #AC3528-129-1) was administered
to groups of 30 male and 30 female Charles River CD(SD)BR rats in the
diet at levels of 0, 100, 500, or 5,000 ppm (corresponding to 0, 10, 50,
or 500 mg/kg/day). At 5,000 ppm, rats displayed a dark yellow
discoloration of the urine and yellow discoloration of abdominal fat.
Body weight gain and food consumption were decreased. The
hematocrit and hemoglobin levels were decreased and the number of
platelets slightly increased in males. There was an increase in pale or
mottled livers in males and dark red thyroids in both sexes at 5,000
ppm. The absolute weight of the liver was increased in males and
females. Diffuse hypertrophy of the liver was also observed. The
10
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LOEL is 5,000 ppm (500 mg/kg/day) based on decreased body
weight gain and food consumption, decreased hematocrit and
hemoglobin with an increase in platelets in males, red thyroids,
increased liver weight, and hypertrophy of the liver. The NOEL is
500 ppm (50 mg/kg/day).
In a second 13-week feeding study in rats (MRID 00059468),
AC 92,553 technical (pendimethalin) was administered to groups of 25
male Long-Evans rats in the diet at levels of 0, 25, 50, 100, 500, or
2,500 ppm (corresponding to 0, 2.5, 5.0, 10.0, 50.0, or 250 mg/kg/day).
The 2,500 ppm group was raised to 5,000 ppm (500 mg/kg/day) from
week 8-13. There were no adverse effects noted with respect to
mortality, body weight and gross and microscopic examination of
mammary glands. The LOEL was not determined. The NOEL was
greater than 2,500 ppm (250 mg/kg/day). Although this study is
classified as Supplementary it provides useful information.
In a third 13-week study in rats (MRED 00059469), AC 92,553
technical pendimethalin was administered to Sprague-Dawley rats in the
diet at 0 or 2,500 ppm (corresponding to 0 or. 250 mg/kg/day). There
were no adverse effects noted with respect to mortality, body weight
and gross and microscopic examination of the mammary gland. The
LOEL was not determined. The NOEL was greater than 2,500 ppm
(250 mg/kg/day). Although this study is classified as Supplementary it
provides useful information.
In a special 92-day thyroid function feeding study (MRID
42054601), AC 92,553 (pendimethalin, 92.6%, Lot#AC5213-72A) was
administered to groups of 80 male CD[Crl:CD(SD)] rats at dose levels
of 0, 100, or 5,000 ppm (corresponding to 0, 4.98, or 245.4 mg/kg/day)
for 92 days. Groups of 20 male rats were sacrificed at 15, 29, 57 and 92
days. At 100 ppm there was decreased total T4, rT3, total free T4 and
increased percent T3, increased follicular cell height and decreased area
occupied by colloid. At 5,000 ppm there were decreased body weight
and food consumption compared to controls, increased thyroid weight,
decreased total T4, total T3, rT3, total free T4 and [I25I]-T4 to transthyretin
bonding, increased percent free T4, percent free T3 and [12SI]-T4 to
albumin binding, increased follicular cell height and decreased area
occupied by colloid and ultrastructural thyroid changes. Most
parameters were reversible after treatment subsided except for
decreased body weight. The NOEL was establised at 100 ppm (4.98
mg/kg/day). The LOEL was determined to be 5000 ppm.
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In a special 56-day feeding study (28-day treatment, 28-day
recovery) to determine thyroid function (MRID 4313.5001), groups of
65-70 (5-15 per sacrifice time) male Crl:CD(SD) rats were treated at
dose levels of 0, 500 or 5000 ppm (0, 31 or 292 mg/kg/day) of AC
92,553 (pendimethalin, 92.6%, Lot #AC5213-72A) in the diet for 28
days. A recovery period of up to 28 days was employed. Animals were
sacrificed at many timepoints during the study beginning as early as day
3. There were no deaths or clinical signs of toxicity during or after the
treatment period at either dose. At 500 ppm there was decreased total
T4 (38%), rT3 (25%) and total free T4 (28%) and increased percent free
T3 (13%), increased follicular cell height (40%) and decreased area
occupied by colloid (51%) during treatment. At 5000 ppm, body weight
(8%), body weight gain (29%) and food consumption (15%) were
decreased compared to controls during the treatment period. Thyroid
changes during treatment with 5000 ppm included: increased absolute
(15%) and relative (23%) thyroid weight; decreased total T4 (74%), total
T3 (25%), rT3 (36%), total free T4 (40%), and [125I]-T4 to transthyretrin
binding; increased percent free T4 (117%), percent free T3 (26%) and
[12SI]-T4 to albumin binding; increased follicular cell height (75%) and
decreased area occupied by colloid (45%); ultrastructural thyroid
changes were consistent with mild to moderate TSH stimulation except
for the accumulation of dense-bodies in the cytoplasm which may be
reaction products of AC 92,553. Many of these effects were observed
as early as day 3. Most parameters were reversible post treatment
except for a slight decreased body weight compared to controls (7%) at
5000 ppm. There were no changes in TSH, total free T3 or diameter of
follicular cells. The LOEL was 500 ppm (31 mg/kg/day) based on
thyroid effects. The NOEL could not be determined.
In a special 14-day feeding study to determine thyroid function
(MRID 43135003), AC 92,553 (pendimethalin, 92.6%, Lot#AC5213-
72A) was administered in the diet to groups of 10 male Crl:CD(SD) rats
at dose levels of 0, 100 or 5,000 ppm (corresponding to 0, 10 or 500
mg/kg/day). At 5000 ppm AC 92, 533 for 14 days, TSH was increased
and T4 and T3 were decreased. No treatment related effects were
observed for rT3 levels, thyroid weight, 131I uptake in MIT, DIT or T4.
There was a significant increase of 131I uptake by the thyroid of rats in
the 5000 ppm group and an increase in incorporation of 131I in T3. Total
T3 and T4 levels in the thyroid were not affected by treatment at 5,000
ppm. The LOEL is 5,000 ppm (500 mg/kg/day) based on thyroid
effects. The NOEL is 100 ppm (10 mg/kg/day.)
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In a second special 14-day feeding study to determine biliary
excretion and hepatic metabolism, AC 92,553 (pendimethalin, 92.98%,
Lot #AC6539-77A) was administered to groups of 10 male Crl:CD(SD)
rats at dose levels of 0, 100, or 5,000 ppm (corresponding to 0, 10, or
500 mg/kg/day). Ingestion of 5,000 ppm produced decreases in serum
T3 and T4 with a compensatory increase in TSH. Also increased were
liver weight, bile flow and cumulative biliary excretion of1251-T4 with a
slight increase in T4-glucuronytransferase activity detected by
generation of1251-T4 glucuronide from 12SI-T4 in vitro by hepatic
microsomes. The increase in enzyme activity was also demonstrated m
vivo by a significant increase in biliary excretion of I251-T4-
glucuronide. The LOEL is 5,000 ppm (500 mg/kg/day) based on
thyroid effects. The NOEL is 100 ppm (10 mg/kg/day).
Feeding Studies in Dogs: In a 90-day feeding study (MRID
00026672), pendimethalin was administered to groups of 8 dogs at dose
levels of 0, 62.5, 250 or 1,000 mg/kg/day. Body weight loss was
apparent at 250 and 1,000 mg/kg/day. The LOEL is 250 mg/kg/day
based on body weight loss. The NOEL is 62.5 mg/kg/day Although
this study is classified as Supplementary it provides useful information.
In a 30-day feeding study in dogs (MRID 000106754) AC
92,553 technical .(pendimethalin, 98.7%) was administered to groups of
2 male and 2 female beagles in the diet at dose levels of 0, 0.625% or
1.25% (corresponding to 0, 125 or 250 mg/kg/day). A third test group
received 5% in the diet (corresponding to 1,000 mg/kg/day) for 30 days.
The protocol was changed so that dogs received the compound by
gelatin capsule from days 17 to 30. Food consumption and body weight
were decreased in all treated groups compared to controls. The LOEL
was 125 mg/kg/day based on decreases in body weight and food
consumption. The NOEL could not be determined. Although this
study is classified as Supplementary it provides useful information.
Feeding Study in Mice: In a 30-day feeding study in mice
(MRID 000106754), pendimethalin technical (98.7%) was administered
to groups of 10 male and 10 female CF-1 mice in the diet at levels of 0,
500, 1,000 or 2,000 ppm (corresponding to 0, 75, 150 or 300
mg/kg/day). There were no adverse effects with respect to mortality,
body weight, food consumption and organ weight. The LOEL was not
determined. The NOEL is greater than 2,000 ppm (300 mg/kg/day).
Although this study is classified as Supplementary it provides useful
information.
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Dermal Study in Rabbits: In a 21-day dermal toxicity study
(MRID 00026663), AC 92,553'(pendimethalin) was dermally applied to
the back of 3 or 4 New Zealand white rabbits/group at dose levels of 0,
250, 500 or 1000 mg/kg/day. There were no adverse effects with
respect to mortality, food and water intake, hematology, urinalysis and
gross and microscopic pathology. The systemic LOEL was not
determined. The systemic NOEL is greater than 1000 mg/kg/day.
c. Chronic Toxicity/Carcinogenicity
Feeding Studies in Rats: In a 2-year study in rats (MRID
40174401), AC 92,533 (pendimethalin, 91.9%, Lot #AC3 528-129-1),
was administered to groups of 55 male and 55 female Crl:CD(SD)BR
rats in the diet at levels of 0, 100, 500 or 5,000 ppm (corresponding to
0, 5, 25, or 250 mg/kg/day). Ten rats/sex/group were interim sacrificed
at 12 months. At 5,000 ppm, survival in males was slightly decreased
and body weight gain was decreased. There was decreased food
consumption, increased gamma glutamyl transferase and cholesterol,
increase in liver weight and/or liver body and/or brain weight ratios,
generalized icterus, dark adipose tissue in females, diffusely dark
thyroids, follicular cell hyperplasia of the thyroid. At 500 ppm there
was pigmentation of thyroid follicular cells in males and females. The
LOEL is 5000 ppm (250 mg/kg/day) based on decreased survival,
body weight gain and food consumption, increased gamma
glutamyl transferase and cholesterol, increase in absolute and/or
relative liver weight, generalized icterus, dark adipose tissue in
females, diffusely dark thyroids and follicular cell hyperplasia of
the thyroid. The NOEL is 500 ppm (25 mg/kg/day). There are
thyroid follicular cell adenomas at 5000 ppm (250 mg/kg/day).
In a second 2-year feeding study in rats (MRID 42027802), AC
92,533 (pendimethalin, 92.6%, Lot #AC5213-72A) was administered to
groups of 125 male Sprague-Dawley (Crl:CD(SD)BR) at dose levels of
0, 1250, 2500, 3750, or 5000 ppm (corresponding to 0, 51, 103, 154,
and 213 mg/kg/day). Fifteen rats/group were interim sacrificed at 1, 13,
26, 39 and 52 days. There was decreased colloid and increased cysts of
the thyroid follicular cells and an increase in liver weight at 1250 ppm
and above. At 2500 ppm and above there was increased pigment and
hypertrophy of follicular cells, increased thyroid weight and an increase
in eosinophilic and basophilic foci of cellular alteration, hepatocellular
enlargement and hepatocellular intracytoplasmic inclusions. There was
a decrease in body weight gain at 3750 ppm and above and hyperplasia
of follicular cells. At 5000 ppm GGT and total cholesterol were
14
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increased and there was an increase in thyroid follicular adenomas. The
LOEL is less than or equal to 1250 ppm ฃ51 mg/kg/day) based on
non-neoplastic thyroid follicular cell changes and increased liver
weight. The NOEL was not determined.
Feeding Study in Mice: In an 18-month feeding study in mice
(MRID 40909901), AC 92,533 (pendimethalin, 92.6%, Lot#AC5218-
72A) was administered to groups of 65 male and 65 female Charles
River CD-I mice at dose levels of 100, 500, or 5,000 ppm
(corresponding to 12.3, 62.3 and 622.1 mg/kg/day in males and 15.6,
78.3 and 806.9 mg/kg/day in females). There were 2 control groups
consisting of 65 mice/sex each. Ten mice/sex were sacrificed at 12
months in one control and all treated groups. (One control group only
consisted of 55 mice/sex.) At 5,000 ppm there was increased mortality
in females, decreased body weight in females, increased absolute
thyroid, liver and gall bladder weights and/or relative body and brain
weight ratios in males and females and amyloidosis in males. The
LOEL is 5,000 ppm (622.1 mg/kg/day [M]; 806.99 mg/kg/day [F])
based on mortality, body weight decrease, organ weight changes
and amyloidosis. The NOEL is 500 ppm (62.3 mg/kg/day [M]; 78.3
mg/kg/day [F]).
Oral Study in Dogs: In a 2-year oral study in dogs (MRID
00058657, 44106801), AC 92,533 (pendimethalin, 91.4%, Lot #77-02)
was administered via capsule to groups of 4/sex beagle dogs at dose
levels of 0, 12.5, 50 or 200 mg/kg/day. In addition to routine
histopathology, special stains were used on liver slides, including the
Gomori's and Hall's method to evaluate lesions observed in this organ.
Slight pigment accumulation (probably chemical) in hepatocytes is
observed in the 50 and 200 mg/kg/day doses and is considered of no
toxicologic concern. The NOEL is>200 mg/kg/day with no LOEL
established.
d. Developmental Toxicity
Oral Study in Rats: Pendimethalin (94.2% a.i.) was administered
in corn oil to groups of 30 mated Sprague-Dawley CD strain rats by
gavage at daily dose levels of 0, 125, 250, or 500 mg/kg/day from
gestation day 6 through 15 (MRID 00025752). Females were observed
for signs of toxicity, and body weights were measured during gestation.
Animals were sacrificed on gestation day 21 and reproductive
observations were made and uteri were examined for live fetuses and
intra-uterine deaths. Fetuses were weighed, sexed, and examined for
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external, visceral and skeletal alterations. There were no maternal or
developmental effects noted at any dose level tested, and based on these
results, the NOELs for developmental and maternal toxicity are
kSOO mg/kg/day (highest dose tested). Although this study is
classified as Supplementary, when considered in conjunction with the
rabbit developmental toxicity study (MRID 00117444) it will satisfy
guideline requirement 83-3. It is not upgradable because an adequate
dose range may not have been tested.
Oral Study in Rabbits: Pendimethalin was administered in corn
oil to groups of 20 artificially inseminated New Zealand White strain
rabbits by gavage at dose levels of 0, 15, 30, or 60 mg/kg/day from
gestation day 6 through 18 (MRID 00117444, 44106803, 44106804).
Females were observed for signs of toxicity, and body weights were
measured during gestation. Animals were sacrificed on gestation day
29 and reproductive observations were made and uteri were examined
for live fetuses and intra-uterine deaths. Fetuses were weighed, sexed,
and examined for external, visceral and skeletal alterations. No
maternal toxicity was reported at doses ^60 mg/kg/day (highest dose
tested). However, the range-finding study indicated that doses ฃ 125
mg/kg/day were associated with increased mortality (3/5, 5/5 and 4/5 in
the 125, 250,' and 500 mg/kg/day groups, respectively compared with
0/5 in the control group). The maternal LOEL is greater than 60
mg/kg/day and the maternal NOEL is equal to or greater than 60
mg/kg/day. There was no increase in developmental effects at any
dose. The developmental LOEL is greater than 60 mg/kg/day and
the developmental NOEL is equal to or greater than 60 mg/kg/day.
This study is acceptable and satisfies the guideline 83-3 requirements
for a rabbit developmental toxicity study. Although there is no evidence
of maternal or developmental toxicity at any dose in the main study,
there was maternal mortality at 125 mg/kg/day (about twice the high
dose) in a range-finding study.
e. Reproductive Toxicity
Feeding Studies in Rats: In a 2-generation reproduction study
(MRID 417252203), AC 92,533 (pendimethalin, 92.6%, Lpt#AC5213-
72A) was administered to groups of 25 male and 25 female Sprague-
Dawley derived OFA-SD (IOPS-CAW) rats at dose levels of 0, 500,
2500 or 5000 ppm (corresponding to 0, 34, 172 and 346 mg/kg/day) in
males and 0, 43, 216, 436 mg/kg/day in females). There were no
clinical signs or changes in organ weight data. There was a minimal
(5%) decrease in body weight gain and food consumption (possibly due
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to palatability) at 2500 ppm. At 5000 ppm the decrease in body weight
gain was as high as 20 %. Although there were decreases in food
consumption and body weight, food efficiency data are required to
support a conclusion regarding palatability/parental systemic toxicity.
The parental NOEL could not be definitely determined.There were
decreased pup weights during much of lactation at 5000 ppm. The
LOEL for reproductive effects is 5000 ppm (346 and 436 mg/kg/day
in males and females, respectively). The NOEL for reproductive
effects is 2500 ppm (172 and 216 mg/kg/day, in males and females,
respectively).
In a 3-generation reproduction study (MRIDs 00026671,
00040304, 00059470) AC 92,533 technical (pendimethalin) was
administered to groups of 10 male and 20 female Long-Evans rats at
dose levels of 0, 500 or 5000 ppm (corresponding to 0, 25 and 250
mg/kg/day). At 5000 ppm there was a decrease in body weights in male
and female parental animals. The LOEL for parental toxicity is 5000
ppm (250 mg/kg/day) based on decreased body weights. The NOEL
for parental toxicity is 500 ppm (25 mg/kg/day).Pup body weight
gain was decreased during lactation. There were possible decreases in
pups born alive and pup survival. The LOEL for reproductive
toxicity is 5000 ppm (250 mg/kg/day) based on pup body weight
gain and possible decreased pups born alive and pup survival. The
NOEL for reproductive toxicity is 500 ppm (25 mg/kg/day).
f. Mutagenicity
There are acceptable studies to satisfy the initial mutagenicity
testing requirements for all three categories (gene mutations, structural
chromosomal aberrations, and other genotoxic effects). The
Carcinogenicity Peer Review Committee concluded that pendimethalin
was not mutagenic in mammalian somatic cells and germ cells. No
other mutagenicity studies are required at this time.
In a reverse gene mutation assay in bacteria (MRID 00153768),
strains (TA1535, TA1537, TA1538, TA98, TA100) of S. tvphimurium
were exposed to AC 92,533 (pendimethalin, 92.2%, Lot #AC3528-129-
1) at concentrations of 50, 158, 500, 1581 or 5000 //g/plate in the
presence and absence of mammalian hamster S9. Subsequent tests with
TA98, TA1538 and TA100 used dose levels of 250, 500, 1000, 3000 or
5000 /ug/plate. AC 92,533 was tested up to the limit dose of 5000
y^g/plate. A precipitate was formed at 5000 /^g/plate. The positive
controls did induce the appropriate responses in the corresponding
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strains. This study was considered positive since there was evidence
of a 2-fold dose-related increase in the number of induced mutant
colonies over background at all doses from 50 to SOOQ/g/plate.
In a Salmonella/microsome plate incorporation assay and in an
Escherichia coli WP2(uvrA) reverse mutation assay (MRID 43177801),
strains TA98, TA100, TA1535, TA1537, TA1538 and WP2(uvrA) were
exposed to pendimethalin at concentrations of 25, 50, 100 250, 500 and
750 /^g/plate, with and without exogenous metabolic activation.
Preparations for metabolic activation S9 were made from Aroclor 1254
induced male Sprague-Dawley rat livers. The test material was
delivered in DMSO. No cytotoxicity was seen at any concentration of
'pendimethalin tested. The upper concentration was limited by test
material solubility (a precipitate was observed at concentrations of 750
^g/plate and above). Positive and vehicle control values were
appropriate. There was no evidence of an increase number of
mutant colonies over solvent control values at any concentration of
pendimethalin tested, either with or without S9 mix.
In a Salmonella/microsome plate incorporation and disk assay
and in an Escherichia coli WP2(uvrA) reserve mutation assay (MRID
43135005), strains TA98, TA100, TA1535, TA1537, and WP2(uvrA)
were exposed to pendimethalin (90.7% , Lot #AC8088-149) at 50, 158,
500, 1581 and 5000 /zg/plate or 1000 /Ltg/paper disk/plate, with and
without exogenous metabolic activation. Preparations for metabolic
activation were made from Aroclor 1254 induced male rat livers. The
test material was delivered in Dimethylsulfoxide (DMSO). Cytogenetic
determinations were not made or discussed in this study. The highest
concentration was limited by solubility (a precipitate was seen at 1581
and 5000 /zg/plate). Positive and vehicle controls were appropriate.
There was no evidence of induced mutant colonies over background
vehicle control values at any concentration of pendimethalin tested
in any strain with or without S9 mix.
In a Salmonella/microsome plate incorporation and disk assay
and in an Escherichia coli WP2(uvrA) reverse mutation assay (MRID
43135006), strains TA98, TA100, TA1535, TA1537, TA1538, and
WP2(uvrA) were exposed to pendimethalin (99.5%, Lot #AC5042-52F)
at concentrations of 50, 100, 250, 500, and 750 /^g/plate without
exogenous metabolic activation and to the same concentrations plus an
additional concentration of 25 //g/plate with exogenous metabolic
activation. A confirmatory assay tested concentrations of 25, 50, 100,
250, 500 and 750 Aig/plate both with and without S9 mix. Preparations
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for metabolic activation were made from Aroclor 1254 induced male rat
livers. The test material was delivered in DMSO. No cytogenicity was
seen at any concentration tested up to 5000 /ug/plate. The upper
concentration tested was limited by solubility of the test material.
Positive and vehicle control values were appropriate. No evidence of a
mutagenic response was seen at any dose in any strain with or
without S9 mix in either assay.
In a forward mutation study (MRID 43177802) at the HGPRT
locus in Chinese hamster ovary CHO-K1-BH4 cells in culture, cells
were exposed to pendimethalin (90.9%, Lot #AC5042-37D) at
concentrations of 1, 5, 7.5, 10, 20, 30, 40, and 50 //g/ml in the absence
of an exogenous metabolic activation system and to 10, 25, 50, 75, 100,
125, 150, and 175 //g/ml in the presence of an exogenous metabolic
activation system (S9-mix). Preparations for metabolic activation were
made from Aroclor 1254 induced male Sprague-Dawley rat liver. The
test material was delivered in DMSO. Cytotoxicity was unacceptably
high at 30, 40 and 50 /zg/ml in the absence of S9 mix and at 125, 150,
and 175 (J,g/ml with S9 mix; therefore, mutagenicity was not evaluated
at these concentrations. A yellow precipitate was seen at concentrations
>50 /-ig/ml. Positive, negative, and vehicle control values were"
appropriate. There was no evidence of induced mutant colonies over
background either with or without S9 mix at any concentration
evaluated in this study.
In a chromosomal aberration study (MRID 00153770), Chinese
hamster ovary (CHO) cells were exposed to AC 92,533 (pendimethalin,
92.2%, Lot #AC3528-129-1) at dose levels ranging from 5 to 25
/zg/plate with or without rat liver S9 and at 12.5 to 100 /zg/ml with rat
liver S9. There was no induction of chromosomal aberrations in
CHO cells at dose levels of up to 25/zg/plate without S9 and up to
100^g/ml with S9.
In a mouse micronucleus study (MRID 42027801), AC 92,533
(pendimethalin, 92.98%, Lot #AC6539-77A) was administered to 5
male and 5 female ICR mice by gavage at dose levels of 313,625 or
1250 mg/kg. Administration of AC 92,533 did not cause a significant
increase in the frequency of micronucleated polychromatic erythrocytes
(MPEs).in bone marrow cells harvested 24, 48, or 72 hours
posttreatment. Deaths and other signs of compound toxicity were seen
in high-dose males and females. Although there was no evidence of a
cytotoxic effect on the target organ (bone marrow cells), the findings of
overt toxicity at 1250 mg/kg (80% of the LD50) clearly indicated that the
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maximum tolerated dose was achieved. Therefore, AC 92,533 was
adequately tested and found to be nonclastogenic in the mouse
micronucleus assay.
In an alkaline elution assay (MRID 43135007), three rats per
dose per sacrifice time were given single intraperitoneal doses of
pendimethalin (90.7%, Lot#AC8088-149) at 1250, 2500 or 5000
mg/kg/body weight. (The alkaline elution assay detects DNA single
strand breaks and DNA/DNA and DNA/protein crosslinks). The test
compound was delivered in corn oil. Testicular cells were harvested 2,
6 and 24 hours after treatment. At the 6 hr sacrifice time, all rats
receiving 2500 or 5000 mg/kg were lethargic while those receiving
1250 mg/kg appeared normal. At 24 hr, rats receiving 5000 mg/kg
appeared lethargic and ungroomed with dehydrated intestinal tissue
while all other rats at lower doses appeared normal. No testicular cell
cytotoxicity as measured by trypan blue exclusion was evident at any
test material dost or sacrifice time. All positive and vehicle control rats
appeared normal at all sacrifice times and no testicular cytotoxicity was
seen. There was no evidence of DNA single strand break induction
or DNA/DNA or DNA/protein crosslink formation at any dose or
sacrifice time.
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g. Metabolism
In a metabolism study (MRID 00046275), when
[14C]pendimethalin was administered to rats, about 70% of the
radioactivity was excreted in the feces and 20% in the urine within 24
hours. The excretion of radioactivity in the urine peaked at 6 to 12
hours wherein 11.2% of the dose was excreted. The maximum residual
radioactivity in the tissues was found in the 6-hour samples (except for
fat at 12 hours). The levels of radioactivity detected in liver, kidney,
muscle, fat, and blood at 6 hours were 29.8, 16.9, 1.3, 12.2, and 5.4
ppm, respectively. Within 96 hours, the radioactivity found in the
tissues was 0.3 ppm or less, except for fat which was 0.9 ppm. The
major portion of the radioactivity that was excreted in the feces was
identified as the parent compound. Pendimethalin is metabolized in rats
mainly through oxidation of the 4-methyl group attached to the benzene
ring as well as oxidation of the alkyl side chain of the N-substituted
dinitroaniline compound.
h. Toxicological Endpoints of Concern Used in Risk Assessment
The Health Effects Division's Reference Dose (RfD), Cancer
Peer Review (CPR), and Toxicological Endpoint Selection (TES)
Committees have evaluated the toxicity data available for pendimethalin
and have identified the following endpoints for risk assessment.
Reference Dose: The HED RfD Committee met on 11/20/95
and 1/5/96 to discuss and evaluate the toxicology data submitted in
support of pendimethalin reregistration and to reassess the Reference
Dose. At that time (RfD memo final 2/6/96) the Committee
recommended that the RfD for pendimethalin be established based on
the chronic toxicity study in dogs with a NOEL of 12.5 mg/kg/day. At
the next higher dose level (50 mg/kg/day), increase in serum alkaline
phosphatase and liver weight and other hepatic lesions were observed.
An Uncertainty Factor of 100 was applied to account for both
interspecies extrapolation and intraspecies variability and the RfD was
calculated to be 0.13 mg/kg/day.
On 7/25/96, the Committee met again (RfD memo final 8/5/96)
to consider pendimethalin. At this time, the Committee changed the
NOEL of the chronic toxicity study in the rat (MRID 40174401) from 5
to 25 mg/kg/day and the NOEL of the chronic oral toxicity study in the
dog (MRID 00058657) was changed from 12.5 mg/kg/day to 200 (the
highest dose tested) based on new data submitted by the registrant.
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At the 7/25/96 meeting, the Committee also agreed that a new
Reference Dose be established based on the results of the subchronic
thyroid special studies. The special studies were considered the most
appropriate because they addressed the critical endpoint
(hormonal/histologic) not addressed in the chronic rat study.
The results of the following rat studies (summarized under
Toxicology Assessment above) were combined to establish the
Reference Dose: (1) subchronic oral 92-day thyroid function study
(MRID 420554601), (2) subchronic oral 56-day thyroid function study
(MRID 43135001), and (3) 14-day intrathyroidal metabolism study
(MRID 4313503).
Choice of NOEL: Subchronic exposure to pendimethalin for 28
days (56-day study) resulted in an LOEL at the lowest dose tested of
500 ppm (31 mg/kg/day) based on several hormonal and histologic
thyroid changes observed throughout the 28 day treatment period. TSH
and organ weights showed no overt changes at this dose. The NOEL in
the 92-day study is 100 ppm (4.98 mg/kg/day) while the 5000 ppm
group exhibited thyroid hormonal, histologic, and organ weight
changes. The NOEL in the 14-day intrathyroidal study was 100 ppm
(10 mg/kg/day) with thyroid hormonal, histologic and organ weight
changes also observed at 5000 ppm. The difference in the NOELs of
4.98 and 10 mg/kg/day (both based on dietary concentrations of 100
ppm) is due to the time weighted average of compound intake. For the
14-day study, the rats received a higher dose of the compound than
older rats due to increased body weight.
The RfD Committee concluded that the 14-day NOEL of 10
mg/kg/day accurately reflects a true NOEL for thyroid effects since
these effects have been demonstrated to have an early onset (before 14
days). On this basis, the Committee decided to consider all three studies
together and establish the LOEL at 31 mg/kg/day and the NOEL at
10 mg/kg/day. An Uncertainty Factor of 100 was applied to account
for interspecies extrapolation and intraspecies variability. The RfD was
calculated to be 0.10 mg/kg body weight/day.
Carcinogenicity Classification and Risk QuantificationiThe
HED Carcinogenicity Peer Review Committee (CPRC) met on 3/18/92
to evaluate the data concerning the carcinogenic potential of
pendimethalin (CPRC memo final 7/24/92). The Committee agreed that
pendimethalin should be classified as a Group C (possible human)
carcinogen, "based on statistically significant increased trend and
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pairwise comparison between the high dose group and controls for
thyroid follicular cell adenomas in male and female rats." The
Committee also concluded (memo 2/6/96), based on an evaluation of
new mechanistic studies submitted to the Agency, that the hypothesis
that thyroid tumors are due to a thyroid-pituitary imbalance can be
supported. However, instead of attempting to quantify potential
carcinogenic risk as a separate endpoint, the Committee recommended
using the 0.10 mg/kg/day RfD, which is protective of both the chronic,
non-carcinogenic effects as well as the carcinogenic effect seen in the
rat The Committee concluded that since pendimethalin was not
mutagenic in mammalian somatic cells and germ cells and mechanistic
studies were available which supported a non-linear approach to risk
assessment, risks (both cancer and non-cancer) could be evaluated by
the RfD approach which is based on thyroid hormonal effects after
short-term pendimethalin exposure. The same study used to establish
the RfD is used for assessing short-term risks, e.g. 1-7 days and 7-90
days. The use of mechanistic data on thyroid effects is consistent with
criteria given in the Agency's Science Policy on thyroid carcinogens
(recently presented to the Science Advisory Board).
Other Toxicological Endpoints: The HED Toxicology
Endpoint Selection Committee (TESC) met on 7/25/96 to evaluate the
toxicological data for pendimethalin with particular reference to
endpoints other than Reference Dose.
Dermal Absorption There were no dermal absorption studies
and no appropriate toxicity studies available to allow an estimation of
the dermal absorption by a route to route comparison of toxicity.
However, structurally related chemicals: oryzalin, trifluralin, and
ethalfluralin have dermal absorption studies (in monkeys) indicating
that absorption is 2.3, 1.0, and 2.8 %, respectively. The solubilities
(water) for pendimethalin and related chemicals oryzalin, trifluralin, and
ethalfluralin are similar: 0.5 ppm, 2.5 ppm, < 1 ppm, arid 0.3 ppm,
respectively. Therefore, for risk characterization purposes, it is
estimated that pendimethalin absorption will be no greater than 10%.
Occupational/Residential Inhalation Exposure:Based on the
LC50 of greater than 320 mg/L, pendimethalin is placed in Toxicity
Category IV. Therefore, inhalation exposure should be considered (for
risk assessment) only if it is greater than 5% of the dermal exposure. If
so, the inhalation exposure estimates should be compared to the NOEL
of 10 mg/kg/day established in the 14-day intrathyroidal study (LOEL
of 31 mg/kg/day from the 56-day thyroid function study which
23
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demonstrated thyroid hormonal effects occurring as early as day 3).
This risk assessment is required only if inhalation exposure is
greater than 5% of the dermal exposure.
Acute (One Day) Dietary Exposure: The TES Committee
concluded that there are no toxicologic endpoints for acute (one-day)
dietary exposure to pendimethalin. This risk assessment is not required.
Short Term Dermal Occupational/Residential Exposure:
The TES Committee concluded that, based on the results of the rat
thyroid studies discussed above under Reference Dose, short term (1-7
day) occupational and residential exposure estimates for pendimethalin
should be compared to the NOEL of 10 mg/kg/day established in the
14-day intrathyroidal study (LOEL of 31 mg/kg/day from the 56-day
thyroid function study which demonstrated thyroid hormonal effects
occurring as early as day 3). This risk assessment is required.
The TES Committee concluded that a 10% dermal absorption
factor should be used as discussed above under Dermal Absorption.
Intermediate Term Dermal Occupational/Residential
Exposure: The TES Committee concluded that, based on the results of
the rat thyroid studies, intermediate term (one week to several months) ,
occupational and residential exposure estimates for pendimethalin
should be compared to the NOEL of 10 mg/kg/day established in the
14-day intrathyroidal study (LOEL of 31 mg/kg/day from the 56-day
thyroid function study). This risk assessment is required.
The TES Committee concluded that a 10 % dermal absorption
factor should be used.
Chronic Dermal Occupational/Residential Exposure:The
TES Committee concluded that, based on the results of the rat thyroid
studies, chronic (90 days or more) occupational and residential exposure
estimates for pendimethalin should be compared to the NOEL of 10
mg/kg/day established in the 14-day intrathyroidal study (LOEL of 31
mg/kg/day from the 56-day thyroid function study). This risk
assessment is required.
The TES Committee concluded that a 10 % dermal absorption
factor should be used.
24
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i. Incident Reports
A search in the Office of Pesticide Programs' Incident Data
System (2/28/96) indicated 12 reports with 3 of these involving 5
humans (the remainder concern fish, wildlife or domestic animals). The
symptoms included signs of systemic illness: vomiting, diarrhea, chills
and shakiness. Three people were hospitalized when they were exposed
to a mixture of pesticides including pendimethalin and nitrogen. The
data base does not indicate the.associated use patterns or activities in
which the poisoned individuals were involved.
The California Pesticide Illness Surveillance Program for 1982-
1992 contained six reports. In three of these reports the effects were
systemic (vomiting, diarrhea, etc.), two had skin effects, and one
involved eye effects.
Pendimethalin ranked 41st on a list of the top 200 active
ingredients for which the National Pesticide Telecommunications
Network (NPTN) received calls during 1982-1991. There were 682
calls, with 91 concerning human poisoning due to pendimethalin.
2. Exposure Assessment
Agricultural food/feed
Pendimethalin [N-(l-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine] is a herbicide registered for use on numerous food/feed
crops. Pendimethalin is manufactured by American Cyanamid Co. under the
trade names Pentagonฎ, Prowlฎ, Pursuitฎ, and Squadronฎ. Formulations
registered for food/feed uses include emulsifiable concentrates (EC), soluble
concentrates/liquid (SC/L), Granulars (G) and water dispersable granules
(WDG) or dry flowables (DF). Pendimethalin is applied to soil as preplant,
preemergence, and postemergence applications, including at layby, with
ground or aerial equipment.
There are eight pendimethalin end-use products (EPs) with food/feed
uses registered to American Cyanamid Co. These EPs are presented in Table 2
below.
25
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Table 2, End-Use Products Registered to American Cyanamid Co.
EPA Reg. No.
241-243
241-244
241-268
241-297
241-315
241-327
241-331
241-337"
Acceptance
Date
7/95
2/87
7/95
2/91
1/93
2/95
10/95
5/95
Formulation
Class
4 Ib/gal EC
3 Ib/gal EC
60% WDG
2 Ib/gal SC/L
2.7 Ib/gal EC
2 Ib/gal SC/L
3 Ib/gal EC
3.3 Ib/gal EC
Product Name
Prowlฎ Herbicide
Prowlฎ 3E Herbicide
Pentagonฎ DG Herbicide
Squadronฎ Herbicide
Pursuitฎ Plus Herbicide
Squadronฎ Herbicide
Pursuitฎ Plus EC Herbicide
Prowlฎ 3.3 EC Herbicide
Including SLN Nos. ID930012, MT930003, NV920004, NY940003, OR930001, OR930002, UT920004;
WA920015, WA920034, WY920005.
Agricultural and Residential non-food
Products containing pendimethalin are intended for both occupational
and homeowner uses. Pendimethalin is used on landscape and grounds
plantings, ornamentals, turfgrass (residential, golf-course, landscape, and sod-
farms). Homeowners use pendimethalin to control weeds on lawns, including
spot treatment. Treatments are also made to homeowner lawns, landscape and
grounds and golf courses by commercial applicators/sprayers. Large scale
applications of pendimethalin are made to ornamental crops. Other ways of
applying pendimethalin include backpack sprayer, low pressure hand wand
(spot treatment), ground boom, or broadcast spreader.
a. Dietary Exposure
The Pendimethalin Guidance Document was issued 3/85.
Pendimethalin was the subject of a product and residue chemistry
Reregi strati on Standard Update issued 4/13/90. These documents
summarized regulatory conclusions regarding the available residue
chemistry data. The 1990 Update specified that additional data were
required for reregi strati on purposes. Several submissions of data have
been received since the Update. The information contained in this
document outlines the current Residue Chemistry Science Assessments
with respect to the reregistration of pendimethalin.
Tolerances of 0.1 ppm (except 0.05 ppm for rice grain) are
established for the combined residues of pendimethalin [N-(l-
ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] and its metabolite 4-
[(l-ethylpropyl)aminoi-2-methyl-3,5-dinitrobenzyl alcohol in/on beans,
26
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corn (field and fresh), cottonseed, onions (dry bulb), peas, peanuts,
potatoes, grain sorghum, soybeans, sugarcane, and sunflower seeds [40
CFR ง180.361(a)]. A tolerance of 0.25 ppm has been established for
the combined residues of pendimethalin and its metabolites 4-[(l-
ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol and3-[(l-
ethylpropyl)amino]-6-methyl-2,4-dinitrobenzyl alcohol in/on peanut
hulls [40 CFR ง180.361(b)]. A tolerance with regional registration of
0.1 ppm has been established for the combined residues of
pendimethalin and its metabolite 4-[(l-ethylpropyl)amino]-2-methyl-
3,5-dinitrobenzyl alcohol in/on garlic [40 CFR ง180.361(c)]. The
molecular structures of pendimethalin and currently regulated
metabolites are depicted in Table 3 below.
Table 3. Chemical names and structures of pendimethalin and its metabolites.
Common/Chemical Names
Structures
Pendimethalin
HNCH(C2Hj)2
N-(l-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine
3,5-Dinitrobenzyl alcohol metabolite
HNCH(C2Hj)2
,NQ,
CH,
4-[(l-ethylpropyl)amino]-2-methyl-3,5-
dinitrobenzyl alcohol
CHjOH
2,4-Dinitrobenzyl alcohol metabolite
HNCH(C2H5)2
N0
T CHjOH
CH,
3-[(l-ethylpropyl)amino]-6-methyl-2,4-
dinitrobenzyl alcohol
27
-------
The Agency has recently updated the Raw Agricultural and Processed
Commodities and Feedstuffs Derived from Field Crops Table (Residue
Chemistry Test Guidelines, OPPTS 860.1000, Table 1 (July 1996)). Additional
residue data are now required for some commodities as a result of changes in
Table 1; these data requirements have been incorporated into this document.
These new data requirements will be imposed at the issuance of the
Pendimethalin RED but should not impinge on the reregi strati on eligibility
decision for pendimethalin. The need for additional tolerances and for
revisions to exposure/risk assessments will be determined upon receipt of the
required residue chemistry data.
171-4 (a): Plant Metabolism
The qualitative nature of the residue in plants is understood based on
adequate studies conducted with [14C]pendimethalin on potatoes and sweet
corn. The results of these studies are supported by additional corn, cotton, dry
bean, lima bean, peanut, potato, red table beet, rice, snapbean, soybean,
sugarcane, and wheat metabolism data. Pendimethalin per se and its 3,5-
dinitrobenzyl alcohol metabolite are the residues of concern.
The current tolerance expressions specify the combined residues of
pendimethalin and its 3,5-dinitrobenzyl alcohol metabolite and, for peanut
hulls, the 2,4-dinitrobenzyl alcohol metabolite as well.
GLN 171-4 (b): Animal Metabolism
Adequate goat and poultry metabolism studies are available. The
Agency has determined that there is no reasonable expectation of finite
pendimethalin residues of concern in animal commodities (40 CFR
ง180.6(a)(3)). No additional animal metabolism, analytical methods, storage
stability, and magnitude of the residue data are required. Tolerances for
pendimethalin residues of concern in livestock commodities are not needed.
GLN 171-4 (c) and (d): Residue Analytical Methods-Plants and Animals
Adequate methods are available for data collection and tolerance
enforcement. Methods I through IV in PAM Vol. II are gas
chromatography/electron capture (GC/ECD) methods. Methods used for data
collection are essentially the same as the PAM Vol. II methods.
The FDA PESTDATA database dated 1/94 (PAM Volume I, Appendix
1) indicates that pendimethalin is completely recovered (>80%) by
Multiresidue Methods Section 302 (Luke method; Protocol D) and 303 (Mills,
28
-------
Onley, Gaither method; Protocol E, nonfatty), and partially recovered (50-80%)
by Multiresidue Method Section 304 (Mills fatty food method; Protocol E,
fatty).
GLN 171 -4 (e): Storage Stability
The Agency concludes that available storage stability data on almonds
(representative of oilseeds), alfalfa seed (representative of non-oily seeds),
onions, potatoes, soybean forage and hay, wheat straw, and alfalfa forage and
hay adequately support the plant magnitude of the residue data. No additional
storage stability data are required.
GLN 171-4 (k): Magnitude of the Residue in Plants
The reregi strati on requirements for magnitude of the residue in/on beans
(succulent and dry); bean forage; bean fodder; corn stover (fodder); corn
forage; field corn; pop corn; sweet corn (K+CWHR); cottonseed; garlic; onions
(dry bulb); peanuts; peanut hay; potatoes; rice grain; rice straw; sorghum stover
(fodder); sorghum forage; grain sorghum; soybeans; soybean forage; soybean
hay; sugarcane; and sunflower seeds have been satisfied. Tobacco magnitude
of the residue data remain outstanding and are considered confirmatory.
Pendimethalin residue data requirements for cotton gin byproducts
which result from changes in the Raw Agricultural and Process Commodities
and Feedstuffs Derived from Field Crops Table (Table 1 (July 1996)) should be
imposed at this time. However, this requirement should not impinge on the
reregi strati on eligibility decision for pendimethalin. The need for additional
tolerances and revisions to the exposure/risk assessments will be made upon
receipt and evaluation of required data.
GLN 171-4 (1): Magnitude of the Residue in Processed Food/Feed
Adequate data are available to demonstrate that pendimethalin residues
of concern do not concentrate in commodities derived from corn, cottonseed,
peanuts, potatoes, soybeans, sugarcane, and sunflower seeds. Rice processing
data remain outstanding and are considered confirmatory.
GLN 171-4 (j): Magnitude of the Residue in Meat, Milk, Poultry, and Eggs
The Agency has determined that there is no reasonable expectation of
finite pendimethalin residues of concern in animal commodities (40 CFR
ง180.6(a)(3)). Therefore, livestock feeding studies and tolerances on livestock
commodities are not required.
29
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Guidelines 165-1 and 165-2: Confined/Field Rotational Crops
t
Preliminary review of confined rotational crop data (Guideline 165-1);
indicates that plantback label restrictions are required unless the registrant
wishes to conduct limited field rotational crop studies (Guideline 165-2).
These considerations will not preclude the reregistration of pendimethalin.
b. Occupational and Residential Exposure
An occupational and/or residential exposure assessment is required for
an active ingredient if (1) certain toxicological criteria are triggered and (2)
there is potential exposure to handlers (mixers, loaders, applicators, etc.) during
use or to persons entering treated sites aftef application is complete.
Handler (Mixer/Loader/Applicator) Exposures and Assumptions
The Agency has determined that there is potential exposure to persons handling
pendimethalin. Handler exposures may occur to:
Occupational handlers involved in food, feed, fiber, ornamental, turf, rights-
of-way or other treatments, and
Homeowners making applications to residential turf.
No handler exposure studies were conducted by the Registrant for
pendimethalin.
The Agency has determined that there is potential exposure to mixers,
loaders, applicators, and other handlers during usual use-patterns associated
with pendimethalin. Based on the use patterns described above, thirteen major
exposure scenarios were identified for pendimethalin: (la) mixing/loading
water-dispersible granulars (dry flowables) for rights-of-way sprayers; (1'b)
mixing/loading water-dispersible granulars (dry flowables) for groundboom
applications; (2) mixing/loading wettable powders (water soluble packets) for
groundboom application (Note: all currently registered wettable powder end-
use products are packaged in water soluble packets); (3) loading granulars for
solid-broadcast applications; (4a) mixing/loading liquid for aerial applications
and irrigation systems (the mixer/loader scenario for aerial and irrigation
applications were combined since they use the same mixing/loading techniques
and similar acres treated and application rates); (4b) mixing/loading liquid
formulations for rights-of-way spraying; (4c) mixing/loading liquid
formulations for groundboom applications or to impregnate dry bulk fertilizer.
30
-------
(Note: impregnating dry bulk fertilizer is included in this scenario since the
daily amount of liquid formulation handled would be approximately the same
as the amount handled to support groundboom applications); (5) applying as a
spray with aerial (fixed wing) equipment; (6) applying as a spray with rights-
of-way equipment; (7) applying as a spray with groundboom equipment; (8)
applying granulars with a tractor-drawn broadcast spreader; (9) flagging during
aerial spray application; (10) mixing/loading/applying as a spray with backpack
sprayer; (11) mixing/loading/applying with a low-pressure handwand sprayer;
(12) mixing/loading/applying with a push-type granular broadcast spreader;
and (13) mixing/loading/applying using a high-volume turf sprayer (similar to
those used for turfgrass applications by commercial handlers).
Daily dermal exposureis calculated using the following formula:
Daily Exposure (mg ai/day) =
Unit Exposure (mg ai exposure/lb ai amount handled) x Use Rate (Ib ai/Acre) x
Daily Area Treated (Acre/day)
A body weight of 70 kg was applied to the Daily Dermal Exposure to find the
Daily Dermal Dose.
Absorbed Daily Dermal Dose is calculated using the following formula:
Absorbed Daily Dermal Dose (mg ai/kg bw/day) =
Unit Exposure (mg ai/lb ai) x Use (Ib ai/A) x Daily Acres Treated (A/day) /
Body Wt (kg) x 0.10 (dermal absorption rate)
The following assumptions were made regarding the area treated:
F6r aerial applications: 800 acres per day (upper-end estimate for field corn,
soybeans, and grain sorghum);
For groundboom applications: 80 acres per day;
For rights-of-way applications: 10 acres per day;
For spot treatments using backpack and low-pressure handwand sprayers: 1,000 square feet
per day by homeowner applicators and one acre per day by commercial applicators; and
For residential turf applications: one acre per day by homeowner applicators using a
broadcast spreader and eight acres per day by commercial applicators using high-volume turf
31
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sprayers.
Other assumptions regarding worker exposure include the following:
Commercial handlers would be expected to have short- and intermediate-term exposures
whereas homeowner handlers would be expected to have only short-term exposures.
However, since the toxicological endpoint is the same for short-term and intermediate-term
exposures, the exposures and risks are represented in the same tables.
Aerial applicators are in enclosed cockpits (there are no data available for the open cockpit
scenario).
Wettable powder formulations are contained in water-soluble packaging (all currently
registered wettable powder products are in water soluble packaging).
Adult male body weight = 70 kg
Based on pendimethalin product labels and available use information, the Agency believes
that a reasonable worst-case frequency of occupational exposure would be six days per week
for 1-2 months for postpplication workers cultivating, irrigating, and performing other routine
reentry tasks following applications to agricultural crop sites; or, for nursery and landscape
workers working with ornamentals, a worst-case frequency of exposure would be intermittent
exposure of 1-2 weeks at a time, several times per season, but not continuous throughout the
season. This is characteristic of intermediate-term rather than chronic exposure.
For residential exposures, a reasonable worst-case frequency of exposure would be 2-3
weeks, 4 times per year for reentry to lawns treated with pendimethalin. This is based on a
maximum of 3-4 applications per year to residential turf. This is also characteristic of
intermediate-term exposure.
For these reasons and since chronic occupational or .residential exposure is not expected, a
cancer risk assessment for workers is not required at this time.
32
-------
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Table 5 below shows the estimated exposure for individuals handling
pendimethalin in both residential and occupational settings. Estimated dermal
exposure values (mg/kg/lb ai) for each task were obtained from the Pesticide
Handler's Exposure Database (PHED), Version 1.1.
35
-------
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Table 5: Short-Terra and Intermediate-Term Ex
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Postapplication Exposures and Assumptions
The Agency has determined that there is potential exposure to persons entering treated sites
after application is complete. Post-application exposures may occur to:
Agricultural workers following applications to commercial or research food, feed, fiber,
ornamental, forestry, and turf crops during routine crop-production tasks, such as planting,
transplanting, incorporation, cultivation, hoeing, scouting, thinning, and harvesting;
Mowers and other golf-course maintenance workers following applications to turfgrass
on golf courses;
Landscape and grounds maintenance workers following applications to commercial
landscape plantings;
Workers following applications in rights-of-way and other noncrop areas; and
Persons, including children, following applications to residential and recreation area turf
or ornamental plantings.
No chemical-specific post-application studies have been conducted by the Registrant for
pendimethalin. In lieu of such studies, EPA has used a registrant-submitted published study
as surrogate data. This study (Hurto and Prinster, 1992) compared foliar dislodgeable
residues (FDRs) for five different chemicals. The study does not meet guideline
requirements, and the Agency therefore has low confidence in the exposure and risk estimates
using this data. However, it is the best available source of data with which to evaluate post-
application exposure and risk pending development of chemical specific post-application data
which meets guideline requirements. Based on the FDR data from the study, EPA has
developed reasonable worst-case estimates to assess the post-application exposure and risk for
three representative post-application scenarios: (1) toddler exposure to residential turf, (2)
maintenance worker exposure to golf course turf, and (3) harvesting turfgrass from a sod
farm. However, it should be noted that the registrant is a member of the Agricultural Reentry
Task Force which is developing agricultural and residential post-application/reentry exposure
data. These post-application risk assessments follow in section b (Occupational and
Residential) portion of Risk Characterization.
3. Risk Characterization
a. Dietary
Food uses evaluated in the Dietary Risk Evaluation System
(DRES) analysis were the published uses of pendimethalin listed in 40
CFR ง 180.361 and the Tolerance Index System (TIS). The analysis
used tolerance level residues for registered commodities.
37
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Reassessed Tolerances:
Based on the Product and Residue Chemistry Assessment of the
Reregistration Eligibility Decision Document (B. Cropp-Kohlligian,
12/12/95), the Agency recommended that tolerances for residues of
pendimethalin on rice be increased from 0.05 ppm to 0.1 ppm due to the
analytical method's limit of quantification for the combined residues of
pendimethalin and its 3,5-dinitrobenzyl alcohol metabolite.
Additionally, the Agency recommended that the tolerance for onions
(dry bulb) be applied to shallots (dry bulb only).
In the DRES analysis, both rice and dry bulb shallots were
included at these recommended tolerance levels. See Table 1 within
Attachment 3, Dietary Risk Assessment, for all the commodities and
tolerances included in this analysis.
Dietary Exposure and Risk from Food: The following DRES
chronic dietary exposure estimates are based on a Theoretical Maximum
Residue Contribution (TMRC). TMRC assumes residues on foods are
at tolerance levels and that 100 percent of each crop registered, for
pendimethalin is treated. Food consumption estimates are averages
taken from the 1977-78 USDA Food Consumption Survey. TMRC
exposure estimates for the overall U.S. population and various
population sub-groups were then compared to the pendimethalin RfD
(0.1 mg/kg/day) with chronic risk expressed as a percent of the RfD.
Based on the above assumptions and including all registered
pendimethalin food uses, DRES estimates chronic exposure to
pendimethalin to be 0.00042 mg/kg/day (< 1% RfD) for the Overall
U.S. population. The estimated most highly exposed DRES sub-group
for pendimethalin is non-nursing infants at a level of 0.00140
mg/kg/day (< 2% RfD).
Dietary Exposure and Risk from Drinking Water:
Pendimethalin is not regulated under the Safe Drinking Water
Act (SDWA) and does not have an established Maximum Contaminant
Level (MCL).
Ground Water: Pendimethalin has a history of high use over a
wide geographic area on several major crops. However, there are few
reports of detections in ground water. Specifically, residues of
pendimethalin have been found in ground water in limited areas of two
states at concentrations of 0.2 to 0.9 ppb.
38
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Surface Water: Pendimethalin may contaminate surface water
from spray drift associated with aerial and ground spray applications, or
in runoff from rainfall and through irrigation waters (chemigation).
Transport of pendimethalin during runoff events which occur soon after
application can be considerable due to its persistence and extensive use.
Pendimethalin has been detected in surface water samples taken
from lower Great Lakes tributaries (Baker, 1988) and in surface water
samples from 13 States as reported in the STORET database. However,
a study by Coupe et al. (1993) of the Mississippi River and its
tributaries did not detect dissolved pendimethalin above the reporting
limit of 0.018 ug/L (which indicates pendimethalin would not be present
in public drinking water).
The maximum reported concentration of pendimethalin is 17.6
ug/L (ppb) from a surface water sample collected in Ohio (STORET
data).
Drinking Water Risk: Exposure and risk estimates for
pendimethalin in drinking water will be based on the following
assumptions:
o A 10 kilogram child will consume 1 litre (L) of drinking water
per day (making children the most highly exposed group, as
demonstrated in exposure estimates for food sources).
o Drinking water is contaminated with pendimethalin at a level
as high as 18 ppb based on the highest reported measured sample in the
STORET database (this level will be used for the purpose of risk
assessment only and does not imply this value is considered typical).
o Contamination at a level of 18 ppb is constant (although actual
durations of maximum levels are not known).
At a level of 18 ppb pendimethalin in water, a 10 kg child will be
exposed at the rate of 0.0018 mg/kg body weight/day. The endpoint for
pendimethalin risk assessment (all exposure durations except 1-day) is
10 mg/kg/day, based on the 14-day thyroid function study. Therefore,
a Margin of Exposure is estimated at > 5,000. A chronic exposure from
dietary intake of 0.0018 mg/kg/day is < 2% of the pendimethalin RfD.
b. Occupational and Residential
Table 6 below shows the estimated risks for individuals handling
pendimethalin in both residential and occupational settings. Estimated
unit dermal exposure values (mg/kg/lb ai) for each task were obtained
from the Pesticide Handler's Exposure Database (PHED), Version 1.1.
39
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The unit exposure value was used to find the daily dose and a
corresponding margin of exposure (MOE) for each use, based on the
short- and intermediate-term (10 mg/kg/day) endpoint of concern
(equations used to find daily exposures are presented in the previous
section on occupational and residential exposure assessment). Risks are
presented in terms of the Margin of Exposure (MOE), described below.
The Toxicology Endpoint Selection Document for pendimethalin (dated
July 25, 1996) specified that NO risk assessment was required for
inhalation exposure unless the inhalation exposure represents more than
five percent of the dermal exposure. In these cases the inhalation
exposures, adjusted by a 50 percent absorption factor, were added to the
absorbed dermal dose and footnoted. The inhalation exposure was
greater than five percent of the dermal exposure for only two scenarios -
- Scenarios 3 and 8.
MOEs from short- and intermediate-term exposures were calculated
using the following formula:
MOE = NOEL / Absorbed Daily Dermal Dose
For pendimethalin, an MOE value of at least 100 is considered adequate.
40
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Handler Risk - Short- and Intermediate-term Risk
Exposure and risk for the short- and intermediate-term uses of pendimethalin are
summarized in Tables 5 and 6. Short- and intermediate-term risk was calculated using the 10
mg/kg/day toxic effect. Exposure estimates are based on the best available exposure data
derived from the Pesticide Handlers Exposure Database (PHED VI. 1), which varied in
quality from high confidence data to low confidence data (see Table 4 for a description of the
confidence level associated with exposure data).
The calculations indicate that the MOEs for short- and intermediate-term exposures for
handlers wearing baseline attire (long-sleeve shirt, long pants, shoes, and socks) are over 100
for all but the following use scenarios: (scenarios 4a, b, c) mixing/loading liquid formulations
for aerial application and irrigation systems (baseline MOE is 1.5), mixing/loading liquids for
rights-of-way application (baseline MOE is 59), mixing/loading liquids for groundboom
application (baseline MOE is 15); and occupational mixing, loading, and applying using low-
pressure handwand equipment (spot treatment) (scenario 11) (baseline MOE is 17). The risks
to these handlers in these scenarios are reduced to an adequate level (MOEs are all above
100) when handlers wear chemical-resistant gloves in addition to baseline attire.
Risk From Postapplication Exposures
EPA has determined that the following post-application exposure and risk scenarios,
based on the surrogate FDR data, are representative worst-case exposure and risk assessments
for other pendimethalin post-application scenarios:
post-application exposure to workers harvesting turfgrass from sod farms is
representative of worst-case post-application exposures to other agricultural
workers following pendimethalin applications to commercial or research food,
feed, fiber, ornamental, forestry, and turf crops.
post-application exposure to golf-course maintenance workers is representative
of worst-case post-application exposures to landscape and grounds
maintenance workers in commercial landscape plantings and in rights-of way
and other non-crop areas.
post-application exposures to toddlers on residential turf is representative of
worst-case post-application exposures to other persons following pendimethalin
applications on turf at residential sites and at parks and recreation areas.
Surrogate Postapplication Data and Derived REIs
RESIDENTIAL TURF
Table 7 presents the MOEs for toddlers on residential turf ranging from the day of
application (two hours after treatment) to two days after application when the MOE exceeded
100 for the maximum application rate. The transfer coefficient (Tc) was estimated by the
43
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Occupational and Residential Branch (OREB) based on the reasonable worst-case activity of
children (3-6 yrs, 17 kg--Exposure Factors Handbook, U.S. EPA, 1990) playing on turf 4
hours per day. The surrogate pendimethalin FDR data from Hurto and Prinster 1992 were
chosen by EPA as the best available surrogate data for residential turf. The surrogate FDR
data in the published study are assumed to represent an application rate of 2.0 Ib ai/A. The
minimum and maximum rates for the residential turf are 1.0 and 3.0 Ib ai/A respectively (EPA
Reg. No. 241-340). An adjustment (i.e., normalization to the maximum application rate of
3.0 Ib ai/A) was made to the surrogate FDR data in.these calculations.
Table 7 : Postapplication Risk Estimates for Residential Turf a
Crop
Residential Turf
HAT/DAT
(hrs or days after
treatment)
2 HAT
1DAT
2 DAT
3 DAT
FDR
&ig/cmj)b
2 Ibs ai/
acre rate
0.4
0.28
0.24
0.12
3 Ibs ai/acre rate
1 0.6
0.42
0.36
0.18
Daily Absorbed Dose
(mg/kg/day)'
2 Ibs per
acre
0.09
0.07
0.06
0.03
3 Ibs per acre
0.14
0.10
0.09
0.04
MOE"
2 Ibs per acre
111
142
167
333
3 Ibs per acre
71
100
111
250
To of 10,000 (crrf/hr) is based on OREB's best estimate.
k Published pendimethalin-specific FDR data (monitored at 2.0 Ib ai/acre) for turf where 2 HAT and 1 and 2 DAT the FDRs are 0.4, 0.28,
and 0.24 /fg/cm1. respectively (Hurto and Prinster 1992).
' Daily Absorbed Dose (mg/kg/day) = [(normalized FDR j^g/cm1) x Tc(cmVhr))/l,000 unit conv.) x 4 hrs/day]/I7 kg] x 0.1 (dermal
absorption).
4 MOE - NOEL (10 mg/kg/day)/Daily Absorbed Dose (mg/kg/day).
GOLF COURSE TURF
Table 8 presents the MOEs for golf course workers at the day of application (2-hrs
after treatment). The transfer coefficient (Tc) was estimated by the Agency based on the
reasonable worse-case tasks of routine golf-course turf maintenance. The surrogate
pendimethalin FDR data from Hurto and Prinster 1992 were chosen by EPA as the best
available surrogate data for the golf course turf. The surrogate FDR data in the published
study represent an application rate of 2.0 Ib ai/A. The maximum rate for the golf course turf
(EPA Reg. No. 241-340) is 3.0 Ib ai/A. An adjustment (i.e., normalization to the 3.0 Ib ai/A
application rate) was made to the surrogate FDR data in these REI calculations.
44
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Table 8: Risk Estimates and Restricted-Entry Interval for Golf Course Turf"
Crop
Golf Course
(Turf)
HAT
(Hours After
Treatment)
2-hrs
FDR
(/Kg/cm2)"
0.60
Daily Absorbed Dose
(mg/kg/day)c
0.003
MOE"
2,917
Tc of 500 (cnrYhr) is based on Occupational and Residential Exposure Branch's (OREB 's) best estimate.
b Published pendimethalin-specific FDR data (monitored at 2.0 Ib ai/acre) for turf where 2 HAT, and 1, 2, and 3 DAT the FDRs are 0.4, 0.28,
0.24, and 0.12^g/cm2 respectively. (Hurto and Prinster 1992).
Daily Absorbed Dose (mg/kg/day) = [(normalized FDR&g/cm2) x Tc(cnvVhr))/l,000 unit conv.) x 8 hrs/day]/70 kg] x 0.1 (dermal
absorption).
* MOE = NOEL (10 mg/kg/day)/Daily Absorbed Dose (mg/kg/day).
SOD FARM TURF:
Table 9 presents the MOEs for sod farm workers ranging from the day of application
(two hours after treatment) to three days after application. The transfer coefficient (Tc) was
estimated by the Agency based on the reasonable worse-case tasks of harvesting sod- The
surrogate pendimethalin FDR data from Hurto and Prinster 1992 were chosen by EPA as the
best available surrogate data for the sod farm turf. The surrogate FDR data in the published
study represent an application rate of 2.0 Ib ai/A. The maximum rate for the sod farm turf is
3.0 Ib ai/A (EPA Reg. No. 241-340). An adjustment (i.e., normalization to the 3.0 Ib ai/A
application rate) was made to the surrogate FDR data in these REI calculations.
EPA notes that the maximum application rate for certain ornamental-crop uses (EPA
Reg. No. 241-340) is 3.96 Ib ai/A. However, the post-application exposures to workers
harvesting or transplanting ornamentals are likely to be lower than the estimated post-
application exposures to workers harvesting turf from sod farms. In the absence of chemical-
specific data, EPA estimates that harvesting sod represents the reasonable worse-case estimate
for post-application exposures to ornamental crops, as well as other food, feed, fiber, and turf
crops.
45
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Table 9: Risk Estimates and Restricted-Entry Interval for Sod Farm Turf'
Crops
( Sod farm
(Turf)
HAT/
DAT(Days
After
Treatment)
2-hrs
I DAT
2 DAT
3 DAT
FDR
(/ig/cm2)6
0.6
0.42
0.36
0.18
Daily Absorbed
Dose (mg/kg/dayy
0.069
0.048
0.041
0.021
MOEd
144
208
244
476
* Tc of 10,000 (ctrf/hr) is based on OREB's best estimate.
* Published pcndimethalin-specific FDR data (monitored at 2.0 Ib ai/acre) for turf where 2 HAT, and 1, 2, and 3 DAT the FDRs are 0.4, 0.28,
0.24. and 0.12 //g/cm1 respectively. (Hurto and Prinster 1992).
Daily Absorbed Dose (mg/kg/day) = [[(((normalized FDR#g/cm2) x Te(cm2/hr))/l,000 unit conv.) x 8 hrs/day]/70 kg] x 0.1 (dermal
absorption).
* MOE - NOEL (10 mg/kg/day)/Daily Absorbed Dose (mg/kg/day).
Exposures following applications to commercial or research food, feed, fiber, turf, and
ornamental crops may be mitigated by. restricted-entry intervals (REIs). REIs allow sufficient
time to pass for residues to dissipate to levels that result in adequate MOEs for entering
workers who contact treated surfaces. However, restricted-entry intervals are not feasible as a
mitigation measure for post-application residential exposures and occupational exposures in
noncrop areas (such as rights-of-ways), or in turf- and ornamental-plant settings such as parks
and landscape plantings.
The Agency has concluded that the following pendimethalin uses indicate an increased
level of concernfor post-application exposures in certain settings, and therefore demand
mitigation. For specific mitigtion measures and the rationales, refer to section IV of this
document.
Most applications to ornamentals and turf are to established plants and are often
broadcast over the entire ornamental and turf foliage, thus increasing potential
exposure risk from foliar contact with such treated foliage;
Workers entering turf and ornamental production (commercial or research) areas
following pendimethalin applications may perform hand-labor tasks such as
transplanting, harvesting, weeding, or pruning. For these crops, the timing of
applications make hand labor activities likely following pendimethalin applications.
Persons, including children, may be exposed to treated turfgrass (lawns) at residential
sites frequently and for relatively long periods of time.
This assessment is based on surrogate, non-guideline data which indicates an increased
level of concern.
46
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4.
Food Quality Act Considerations Regarding Pendimethalin
The Food Quality Protection Act of 1996 (FQPA) amended the FFDCA by
setting a new safety standard for the establishment of tolerances. In determining
whether a tolerance meets the new safety standard, section 408(b)(2)(C) directs EPA to
consider information concerning the susceptibility of infants and children to pesticide
residues in food, and available information concerning aggregate exposure to infants
and children of such residues, as well as the potential for cumulative effects from
pesticide residues and other substances that have a common mechanism of toxicity.
The FQPA amendments to section 408(b)(2)(C) require EPA to apply an
additional 10-fold uncertainty factor (safety) unless reliable data demonstrate that the
additional factor is unnecessary to protect infants and children.
Section 408(b)(2)(D) establishes factors that the Agency must consider in
determining whether the safety standard is met in deciding to issue or reassess
tolerances. These factors include the consideration of available information on the
aggregate exposures to the pesticide from dietary sources including drinking water as
well as non-occupational exposures such as those derived from pesticides used in and
around the home. The Agency must also consider the potential cumulative effects of
the pesticide for which a tolerance is being sought as well as other substances that
have a common mechanism of toxicity.
Because pendimethalin has food uses, specific consideration of the risks to
infants and chUdren, as well as aggregate exposures and potential cumulative effects is
warranted.
a. Potential Risks to Infants and Children
In determining whether an additional uncertainty factor is or is not
appropriate for assessing risks to infants and children, EPA considers all
reliable data and makes a decision using a weight of evidence approach
taking into account the completeness and adequacy of the toxicity data .
base, the nature and severity of the effects observed in pre- and post-natal
studies, and other information such as epidemiological data.
For the purposes of assessing the pre- and post-natal toxicity of
pendimethalin, EPA has evaluated developmental studies in two species
(rat and rabbit), and two- and three-generation rat studies. However, as
EPA fully implements the requirements of FQPA, additional data related to
the special sensitivity of young organisms may be required.
Developmental and Reproductive Effects
In a developmental toxicity study, pendimethalin was administered to
groups of 20 artificially inseminated rabbits by gavage at dose levels of 0,
47
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15, 30, or 60 mg/kg/day from gestation day 6 through 18. No maternal
toxicity was reported at doses equal to or greater than 60 mg/kg/day
(highest dose tested). Therefore the maternal LOEL is greater than 60
mg/kg/day and the maternal NOEL is equal or greater than 60 mg/kg/day.
This dose was considered adequate since maternal mortality was observed
in a range-finding study at 125 mg/kg/day. There was no increase in
developmental effects at any dose. The developmental LOEL greater than
60 mg/kg/day and the developmental NOEL equal to or greater than 60
mg/kg/day.
In a developmental toxicity study, pendimethalin was administered to
groups of 30 mated rats by gavage at daily dose levels of 0, 125, 250, or
500 mg/kg/day from gestation day 6 through 15. There were no maternal
or developmental effects noted at any dose level tested, and based on those
results, the NOELs for developmental and maternal toxicity are equal to or
greater than 500 mg/kg/day (highest dose tested). This dose is considered
adequate because: 1) This dose is about one-half of the acute LD50 for rats
(albeit a different strain). 2) This is one-half of the limit dose of 1000
mg/kg/day. 3) Although not statistically significant, there was about a two-
fold increase in litters with delayed ossification in the extremities that
suggests that the high dose may have approached an effect level. 4) From a
regulatory consideration, this study would not be used for risk calculations
since there is a rabbit study where maternal mortality occurred at lower
dose levels (125 mg/kg/day).
In a two-generation reproduction study, pendimethalin was
administered in the diet to groups of 25 male and 25 female rats at dose
levels of 0, 500, 2500 or 5000 ppm (corresponding to 0, 34, 172 or 346
mg/kg/day in males and 0, 43, 216 or 436 mg/kg/day in females). There
were no clinical signs or changes in organ weight data. There was a
minimal (5%) decrease in body weight gain and food consumption
(possibly due to palatability) at 2500 ppm. At 5000 ppm the decrease in
body weight gain was as much as 20%. Therefore, the parental systemic
NOEL could not be unambiguously determined. There were decreased pup
weights during much of the lactation period at 5000 ppm. Based upon this
finding, the LOEL for reproductive effects is 5000 ppm (346 and 436
mg/kg/day for males and females, respectively). The NOEL for
reproductive effects is 2500 ppm (172 and 216 mg/kg/day, in males and
females, respectively).
Uncertainty Factor
In general, the data base for pendimethalin does not indicate a
potential for increased toxicological sensitivity from pre- and post-natal
exposures. No developmental toxicity was observed in either the rat or
rabbit developmental toxicity studies, nor was there any evidence in the
48
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two generation study that there was developmental or reproductive toxicity
at dose levels below those in which parental toxicity was observed. It is
known that pendimethalin affects the pituatary-thyroid axis; the basis for
the RfD (0.10 mg/kg/day) is based on combined subchronic studies (14
days, and 28 days) in which thyroid hormonal and histologic thyroid
changes were observed. Based on the thyroid effects, pendimethalin by
definition is an endocrine disrupter.
The Act further directs EPA to consider potential for increased
susceptibility of infants and children to the toxic effects of pesticide
residue. The Agency considered the appropriateness of an additional
uncertainty factor, which can be applied in situations where available data
indicate infants and children may have an increased sensitivity to the
pesticide. In general, the data base for pendimethalin does not indicate a
potential for increased toxicological sensitivity from either pre- or post-
natal exposures. No developmental toxicity was observed in either the rat
or rabbit developmental toxicity studies, nor was there evidence in the two-
generation reproduction study of developmental or reproductive toxicity at
dose levels below those in which parental toxicity was observed.
Therefore, the Agency has determined that an additional uncertainty factor
is not warranted.
b. Aggregate Exposure/Risk
In examining aggregate exposure, FQPA directs EPA to take into
account available information concerning exposures from pesticide residues
in food and other exposures for which there is reliable information. These
other exposures may include drinking water and non-occupational
exposures, e.g., to pesticides used in and around the home.
Pendimethalin has both food and non-occupational uses; therefore,
the considerations for aggregate exposure are those from food, drinking
water, and residential (non-occupational) sources.
The following exposure scenarios pertinent to aggregate risk are
associated with pendimethalin uses: chronic dietary, chronic water, and
short-term residential.
Chronic dietary risk
Chronic dietary risks utilizing tolerance level residues and 100% crop
treated (TMRC) are <1% RfD for the general U.S. population, and <2%
RfD for non-nursing infants, the population subgroup with the highest
estimated risk. These risk estimates are extremely conservative; actual
risks utilizing anticipated residue information would be considerably <1%
RfD for all population subgroups.
49
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Chronic water risk
Limited ground water monitoring data are available for pendimethalin
(Pesticides in Ground Water Data Base, EPA, 1992). In the data from 8
states, detectable residues were found in only 2 states, with <1% of wells
monitored having detectable residues. The maximum level found was 0.9
ppb. The maximum level of pendimethalin found in surface water is 17.6
ppb. Based on this information, risks from water are estimated to be <2%
RfD for all population subgroups, including those most highly exposed to
pendimethalin residues.
Short-term residential risk
MOEs for exposures to residential applicators and for post-
application exposures (children) are 833 and 111 respectively. The post-
application risk estimates are based on 2.0 Ibs. ai/acre for residential and
sod farm uses as discussed in the residential risk section of this document.
Although the risk assesssment for children exposed to pendimethalin-
treated lawns showed an acceptable MOE (111), the Agency has low
confidence in the data used for these exposure calculations and these
estimates do not include ingested or inhaled quantities. Therefore., the
Agency has concerns for post-application exposure to children in
residential settings, and has strongly recommended that the maximum
application rate for residential (and sod farms) uses be reduced from 3.0
Ibs. ai/acre to 2.0 Ibs. ai/acre. (The registrant has already agreed to this
reduction in the maximum application rate.)
Aggregate risk estimates
Aggregate risks which must be considered include those from:
(a) chronic food plus chronic water exposure;
(b) (a) plus residential applicator exposure;
(c) (a) plus residential post-application exposure.
The estimated aggregate risks from (a), (b) and (c) are <4% RfD,
MOE = 680, and MOE = 107, respectively. These aggregate risk estimates
do not exceed the Agency's levels of concern.
c. Cumulative Effects
Section 408(b)(2)(d)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's
51
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residues and "other substances that have a common mechanism of
toxicity." The Agency believes that "available information" in this context
might include not only toxicity, chemistry, and exposure data, but also
scientific policies and methodologies for understanding common
mechanisms of toxicity and conducting cumulative risk assessments. For
most pesticides, although the Agency has some information in its files that
may turn out to be helpful in eventually determining whether a pesticide
shares a common mechanism of toxicity with any other substances, EPA
does not at this time have the methodologies to resolve the complex
scientific issues concerning common mechanism of toxicity in a
meaningful way. EPA has begun a pilot process to study this issue further
through the examination of particular classes of pesticides. The Agency
hopes that the results of this pilot process will increase the Agency's
scientific understanding of this question such that EPA will be able to
develop and apply scientific principles for better determining which
chemicals have a common mechanism of toxicity and evaluating
cumulative effects of such chemicals. The Agency anticipates, however,
that even as its understanding of the science of common mechanism
increases, decisions on specific classes of chemicals will be heavily
dependent on chemical specific data, much of which may not be presently
available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most risk
assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which case
the Agency can conclude that it is unlikely that a pesticide shares a
common mechanism of activity with other substances) and pesticides that
produce common toxic metabolite (in which case common mechanism of
activity will be assumed).
EPA does not have, at this time, available data to determine whether
pendimethalin has a common mechanism of toxicity with other substances
or how to include this pesticide in a cumulative risk assessment. Unlike
other pesticides for which EPA has followed a cumulative risk approach
based on a common mechanism of toxicity, pendimethalin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has not assumed that
pendimethalin has a common mechanism of toxicity with other substances.
52
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C. Environmental Assessment
1. Ecological Toxicity Data
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
An oral (LDSO) study (preferably mallard duck or bobwhite quail)
and two subacute dietary (LC50) studies (one species of waterfowl,
preferably the mallard duck and one species of upland game bird,
preferably bobwhite quail) are required to establish the acute and
subacute toxicity of a pesticide to birds. Results of these tests are
tabulated below.
Table 10: Avian Acute Oral Toxicity Findings (LD50)
Species
Mallard Duck
% A.I.
Technical
LDjoCmg/kg)
1,421
Accession No.
Author/Year
00059739 Fiiik/1976
Toxicity
Category
Slightly toxic
Fulfills Guideline
Requirement?
'Yes .
Table 11: Avian Subacute Dietary Toxicity Findings (LC50)
Species
Northern Bobwhite Quail
Mallard Duck
% A.I.
Technical
Technical
LCป (ppm)
4,187
4,640
AccessionNo.
Author/Year
00026675 Fink/1973
00026674 Fink/1973
Toxicity
Category
Slightly toxic
Slightly toxic
Fulfills Guideline
Requirement?
Yes
Yes
These results indicate that pendimethalin is slightly toxic to avian
species on an acute oral and subacute dietary basis. The guideline
requirements (71-1 (a) and 71-2(a) & (b)) are fulfilled (Accession No.
00059739, 00026675, 00026674).
(2) Birds, Chronic
Avian reproduction studies using the technical grade of the active
ingredient are required because pendimethalin has been shown to
have a half-life of 4 days in both field and laboratory studies. It has a
high potential to bioaccumulate in fish. Pendimethalin is a widely
used agrochemical with up to 25 million pounds per year applied
nationwide and may be applied several times per use season on
various crops. Therefore, avian reproduction studies are required for
all use sites. An avian chronic hazard assessment cannot be
completed without these studies. The guideline (71-4) is not fulfilled.
53
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(3) Mammals
Data from available mammalian studies which are used for
human health risk assessment will be used to estimate toxicity to wild
mammalian species. A rat acute oral LDSO study (81-1, MRID
00026657) resulted in an LD50 of 1050 mg/kg for female rats and
1250 mg/kg for male rates. These results indicate that pendimethalin
is slightly toxic to small mammals on an acute oral basis.
A two-generation rat reproduction study (83-4, MRID #
41725203) reported a reproductive NOEL of 2500 ppm and an LOEL
of 5000 ppm.
(4) Insects
A honey bee acute contact LDSO study using the technical grade
of the active ingredient is required for pendimethalin because of the
extensive agricultural use patterns. The result of this test is provided
below.
Table 12: Nontarget Insect Acute Contact Toxicity Findings
Species
Honey Bee
% A.I.
Tech
LDM
(pg/bee)
>49.7
MRID No.
Author/Year
00099890 Atkins/1974
Toxicity Category
Practically nontoxic
Fulfills Guideline
Requirement?
Yes
The results indicate that pendimethalin is practically nontoxic to
bees on an acute contact basis. The guideline requirement (141-1) is
fulfilled (MRID 00099890).
b. Toxicity to Aquatic Animals
(1) Freshwater Fish
Acute
Two freshwater fish toxicity studies using the technical grade of the
active ingredient are required to establish the toxicity of a pesticide to
freshwater fish. One study should use a coldwater species (preferably
the rainbow trout), and the other should use a warmwater species
(preferably the bluegill sunfish). Results of these tests are tabulated
below.
54
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Table 13: Freshwater Fish Acute Toxicity Findings for Technical Pendimethalin .
Species
Rainbow trout
Bluegill sunfish
Channel catfish
% A.I.
93.2
93.2
93.2
LCM (ppm)
0.138
0.199
0.418
Accession No.
Author/Year
106764 Sleight/1973
106764 Sleight/1973
106764 Sleight/1973
Toxicity Category
Highly toxic
Highly toxic
Highly toxic
Fulfills Guideline
Requirement?
Yes
Yes
Yes
The results indicate that technical pendimethalin is highly toxic to
fish on an acute basis. The guideline requirement (72-l(a) & (c)
is fulfilled (Accession No. 106764).
Freshwater fish toxicity studies using a typical end use product
were conducted. Results of these tests are tabulated below.
Table 14: Freshwater Fish Acute Toxicity Findings for the Formulated product
Species
Rainbow trout
Bluegill sunfish
Channel catfish
% A.I.
45
45
45
LAofrpm)
0.52
0.92
1.9
Accession No.
Author/Year
00037927 Bentley/1974
00037927 Bentley/1974
000251601 Sousa/1983
Toxicity Category
Highly toxic
Highly toxic
Moderately toxic
Fulfills Guideline
Requirement?
Yes, for formulation
Yes, for formulation
Yes, for formulation
The results indicate that this formulated product of pendimethalin
is highly to moderately toxic to fish on an acute basis. The guideline
requirement (72-l(b) & (d)) is fulfilled (Accession No. 00037927,
000251601).
Chronic
A fish life-cycle test using the technical grade of the active
ingredient is required for pendimethalin because it can be aerially
applied, it has extensive use sites, many of which may occur near
water bodies, and has a halflife of greater than 4 days: The preferred
test species is the fathead minnow. Results of this test are tabulated
below.
Table 15: Fish Life-Cycle Toxicity Findings
Species
Fathead minnow
% A.I.
98.3
NOEC/LOEC
(Ppb)
6.3/9.8
MATC(ppb)
7.85
Accession No.
Author/Year
00096342
EG&G
Bionomics/1975
Endpoints Affected
Egg productiori
reduced at 9.8 ppb;
reduced hatch at 22
and 43 ppb.
Fulfills Guideline
Requirement?
Yes
55
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The results indicate that reproductive effects to freshwater fish
may occur at levels greater than 6.3 ppb O^g/L). The guideline
requirement (72-5) is fulfilled (Accession No. 00096342).
(2) Freshwater Invertebrates
Acute
A freshwater aquatic invertebrate toxicity test using the technical
grade of the active ingredient is required to assess the toxicity of a
pesticide to freshwater invertebrates. The preferred test organism is
Daphnia magna, but early instar amphipods, stoneflies, mayflies, or
midges may also be used. Results of this test are tabulated below.
Table 16: Freshwater Invertebrate Toxicity for Technical Pendimethalin and the
Formulated Product
Species
Daphnia magna
Daphnia magna
Procambanti simulans Crayfish
% A.I.
Technical
45.6
94.2
LCjo/ECj,,
(ppm)
0.28
5.1
1.0
Accession No.
Author/Year
FAOPEN05
EG&G
Bionomics/1976
260404
Forbis/1985
00099889 ABC
Inc./ 1980
Toxicity Category
Highly toxic
Moderately toxic
Highly toxic
Fulfills Guideline
Requirement?
Yes
Yes for formulated
product
No - supplemental
The results indicate that technical pendimethalin is highly toxic to
aquatic invertebrates on an acute basis and a formulated product of
pendimethalin is moderately toxic to aquatic invertebrates on an acute
basis. The guideline requirement (72-2(a) & (b)) is fulfilled
(Accession No. FAOPEN05 & 260404).
Chronic
Data from an aquatic invertebrate life-cycle test using Daphnia
magna are required because pendimethalin is toxic to Daphnia magna
(EC50 of 0.28 ppm), is registered for uses that involve multiple
applications, and has a halflife of greater than 4 days. Results of this
test are tabulated below.
Table 17: Aquatic Invertebrate Life-Cycle Toxicity Findings
Species
Daphnia magna
%A.I.
92.2
NOEC/LOEC(
ppb)
14.5/35.8
MATC (ppb)
22.78
Accession No.
Author/Year
247299
Gramey/1981
Endpoints
Affected
Mean brood size
Fulfills Guideline
Requirement?
Yes
56
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The results indicate that aquatic invertebrate reproductive
impairment may occur at levels greater than 14.5 ppb (/^g/L). The
guideline requirement (72-4(b)) is fulfilled (Accession No. 247299).
(3) Estuarine and Marine Animals, Acute
Acute toxicity testing with estuarine and marine organisms (fish,
shrimp and oyster embryo-larvae or shell deposition) using the
technical grade of the active ingredient is required for pendimethalin
because of the extensive agricultural use patterns near estuarine and
marine habitats and labeling permits aerial application. Results of
these tests are tabulated below.
Table 18: Estuarine/Marine Acute Toxicity Findings for Technical Pendimethalin
Species
Eastern oyster
(embryo-larvae)
Sheepshead minnow-
Pink shrimp
% A.I.
92.2
92.2
92.2
LCjo/ECj,, (ppm)
0.210
0.707 ,
1.6
Ace. No.
Author/Year
251601 Ward/1983
251601 Ward/1983
251601 Ward/1983
Toxicity Category
Highly toxic
Highly toxic
Moderately toxic
Fulfills
Guideline
Requirement?
Yes
Yes
Yes
The results indicate that technical pendimethalin is moderately to
highly toxic to estuarine/marine organisms on an acute basis. The
guideline requirement (Gdln 72-3 (a), (b), & (c)) is fulfilled
(Accession No: 251601).
Estuarine/marine toxicity studies using the typical end use
product were provided. Results of these tests are tabulated below.
Table 19: Estuarine/Marine Acute Toxicity Findings for Formulated Product
Species
Eastern oyster
(embryo-larvae)
Sheepshead minnow
Pink shrimp
% A.I.
45
45
45
LCs/ECs, (ppm)
0.450
1.7
11
Ace. No.
Author/Year
251601 Ward/1983
251601 Ward/1983
251601 Ward/ 1983
Toxicity Category
Highly toxic
Moderately toxic
Slightly toxic
Fulfills
Guideline
Requirement?
Yes, for
formulation
Yes, for
formulation
Yes, for
formulation
The results indicate that this formulated product of pendimethalin
is slightly to highly toxic to estuarine/marine organisms on an acute
basis. The guideline requirement (Gdln 72-3(d), (e), & (f)) is fulfilled
(Accession No. 251601).
57
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c. Toxicity to Plants
(1) Terrestrial
Terrestrial plant testing (seedling emergence and vegetative
vigor) is required for pendimethalin because it is volatile (vapor
pressure >1.0 x 10'5mm Hg at 25ฐC), it can be aerially applied, and
because it may affect endangered plant species which are located near
the use areas.
For the seedling emergence and vegetative vigor testing the
following plant species and groups should be tested: (1) six species of
at least four dicotyledonous families, one species of which is soybean
'(Glycine'maxX and the second of which is a root crop, and (2) four
species of at least two monocotyledonous families, one of which is
corn (Zeajnays).
Results of Tier II seedling emergence toxicity testing on the
technical material are tabulated below.
Most
Sensitive
Species
Rycgrass
% A.I.
92.98
Parameter Affected
Percent emergence
Percent survival
Phytotoxicity rating
Plant height
Plant weight
NOEC
(Ibs a.i./A)
0.02
0.02
0.02
0.01
0.01
EC,,
(Ibs a.i./A)
0.03
0.06
N/A
0.05
0.02
MRID No.
Author/Year
42372201
Chetram &
Gagne/1992
Fulfills
Guideline
Requirement?
Yes
These results indicate that exposure levels of greater than 0.01 Ibs
a.i./A may cause significant detrimental effects on certain terrestrial
plants. The guideline requirement (123-2) is fulfilled (MRID
42372201).
Results of Tier II seedling germination toxicity testing on the
technical material are tabulated below.
Most Sensitive
Species
Rycgrass
%A.I.
92.98
NOEC
(Ibs a.i./A)
0.25
EC,,
(Ibs a.i./A)
0.82
MRID No.
Author/Year
42372202
White & Gagne/1992
Fulfills Guideline
Requirement?
Yes
These results indicate that exposure levels of greater than 0.25 Ibs
a.i../A may cause significant detrimental effects on the germination of
58
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certain terrestrial plants. The guideline requirement (123-2) is
fulfilled (MRID 42372202).
Results of Tier II vegetative vigor toxicity testing on the technical
material are tabulated below.
Table 22: Nontarget Terrestrial Plant Vegetative Vigor Toxicity Findings (Tier II)
Most
Sensitive
Species
Ryegrass
and lettuce
Onion
Ryegrass
Ryegrass
% A.I.
92.98
Parameter Affected
Phytotoxicity rating
Percent survival
Plant height
Plant dry weight
NOEC
(Ibs a.i./A)
0.063
1.0
0.063
<035
EC^
(Ibs a.i./A)
N/A
1.4
0.10
0.035
MRID No.
Author/Year
42372203
Canez&
Gagne/1992
Fulfills
Guideline
Requirement?
Yes - classified
as supplemental
but fulfills
guideline
requirement
These results indicate that exposure levels of greater than 0.063
Ibs a.i./A may cause significant detrimental effects on the vigor of
certain terrestrial plants. The guideline requirement (123-2) is
fulfilled (MRED 42372203).
(2) Aquatic
Aquatic plant testing is required for pendimethalin. Results of
Tier II toxicity testing on the technical material are tabulated below.
Table 23: Nontarget Aquatic Plant Toxicity Findings (Tier II)
Species
Freshwater diatom
Navicula pelliculosa
Duckweed
.Lemna gibba
Green algae
Selenastrum capricornutum
Marine diatom-
Skeletonema costatum
Blue-green algae
A nabaena flos-aquae
% A.I.
92.98
92.98
92.98
92.98
92.98
ECM (ppb)
5.8
12.5
5.4
5.2
.- 174
NOEC (ppb)
3.2
5.6
3.0
0.7
98
MRID No.
Author/Year
42372206
Hughes et
al/1992
42137101
Hughes et
al/1991
42372204
Hughes et
al/1992
42372205
Hughes et
al/1992
42372207
Hughes et
al/1992
Fulfills Guideline
Requirement?
Yes
Yes
Yes
Yes,
Yes
These results indicate that exposure levels of greater than 0.7 ppb
59
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2.
0/g/L) of pendimethalin may cause detrimental effects to the growth
and reproduction of certain aquatic plant species. The guideline
requirement (123-2) is fulfilled (MRID 42372206, 42137101,
42372204, 42372205, 42372207).
Environmental Fate
a. Environmental Fate Assessment
Pendimethalin dissipates in the environment by binding to soil,
microbially-mediated metabolism, and volatilization. Persistence decreases
with increased temperature, increased moisture and decreased soil organic
carbon. Pendimethalin residues are tightly bound to soil and sediment
particles. Field dissipation information on the major use sites (cotton and
soybeans) that would more clearly describe the environmental fate of
pendimethalin has not been submitted.
Pendimethalin is stable to sterile hydrolysis, soil photolysis, and
anaerobic soil metabolism, but degrades slowly under aqueous photolysis
conditions with a calculated half-life of 21 days. Aerobic soil metabolism
half-lives range from 42-1322 days with 172 days used for the purpose of
exposure assessment. Pendimethalin forms many minor (<10% of applied)
degradates that are primarily an intact benzene ring with rearranged alkyl
groups. Anaerobic aquatic metabolism half-lives ranged from 6 to 105
days. Aqueous residues of parent pendiihethalin and its degradates bind to
sediment in anaerobic aquatic metabolism and soil mobility studies. This is
consistent with mobility studies indicating that pendimethalin is essentially
immobile in all soils studied.
The calculated half-life of pendimethalin in a field study (almond
orchard in California) was 34 days. Although the orchard site is not a
major use site for pendimethalin, the resulting half-life is consistent with
the results from the soil metabolism studies.
Pendimethalin accumulated readily in bluegill sunfish with biological
concentration factors of 1400X in edible, 5800X in non-edible and 5100X
in whole fish, however, depuration was rapid.
Pendimethalin may contaminate surface water from spray drift-
associated with aerial and ground spray application, or in runoff from
rainfall events and through irrigation waters (chemigation). However, the
high affinity for pendimethalin to sorb to soil and sediment particles should
limit concentrations of pendimethalin in surface waters. Pendimethalin was
detected in surface water samples at a maximum of 3.66 (j.gfL in selected
Lower Great Lake Tributaries during 1982-1985. In a study of the spatial
and temporal distributions of pesticides and nutrients in the Mississippi
60
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River and its tributaries, dissolved pendimethalin was not detected in
surface water samples above the reporting limit of 0.018 /ttg/1. Surface
water monitoring results found in the Storage and Retrieval of Water
Quality Data (STORET) database are a compilation of various states'
monitoring data. The maximum concentration of pendimethalin was 17.6
Mg/L (ppb) for a surface water sample collected in Ohio; the next highest
reported concentration was 10 /zg/L with a range of 1-10 (J.g/L. From the
(STORET) data (excluding the highest Ohio sampling results), the
maximum concentrations of pendimethalin in surface water samples range
from 0.01 to3.2^g/L.
Pendimethalin has a low potential to leach to ground water in most
soils. Pendimethalin has a history of high use over a wide geographic area
on several major crops, however, there are few reports of detections in
ground water. Specifically, residues of pendimethalin have been found in
ground water in limited areas in two states. The concentrations found in
ground water were relatively low, ranging from 0.2 to Q.9 ppb.
b. Environmental Fate and Transport
(1) Degradation
Abiotic Hydrolysis
Pendimethalin did not degrade in sterile aqueous buffer solutions
(pH 5, 7, and 9) that were incubated in darkness at 25ฐC for 30 days.
The guideline requirement is fulfilled (Guideline 161-1, MRED
00106777)
Abiotic and Biotic Hydrolysis
Calculated half-lives were 10-11 days (average of 10.6 days) in
water containing different soil fungi and 354 days in sterile water.
Three degradates were formed, which were ring rearrangements and
ring additions. Zimdahl et al., 1990.
Photodegradation in Water
The calculated half-lives were 16.5 days at pH 5, 7, and 9 (MRID
43808201), and 21 days at pH 7 (MRID 00153763). The artificial
light intensity for the new study was for September 13, 1990 at
Princeton, New Jersey and Chicago, Illinois on June 30 and the
temperature was set at 25ฐC. Up to 37 minor degradates were
isolated, but only one degradate was identified, 2,6-dinitro-3,4-
dimethyl aniline (a ring-rearrangement of parent pendimethalin with
an ethylpropyl group removed from an amine group). However, the
61
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degradate did not exceed 9.3% of applied, and no other degradate
reached this amount. Pendimethalin was stable in the dark controls
which is consistent with the hydrolysis study. The guideline
requirement is fulfilled Guideline 161-2, MRIDs
00153763;43808201)
Photodegradation on Soil
Pendimethalin did not degrade on sandy loam exposed to
artificial light at 25ฐC. The guideline requirement is fulfilled
(Guideline 161-3, MRID 00153764).
Photolysis in Air
i
This study is not required because pendimethalin is tightly bound
to soil and its toxicity is in Class 3. Guideline 161-4, waived on
6/27/91.
Aerobic Soil Metabolism
Pendimethalin degraded with a calculated half-life of 1322 days
in sandy loam soil in a study submitted for registration. This half-life
was considered an outlier and was not used in assessing the
environmental fate of pendimethalin. The identified minor degradates
were 2,6-dinitro-3,4-xylidine, 4-[(l -ethylpropyl)amino]-2-methyl-3,5-
dinitro.benzyl alcohol, and 4-[(l-ethylpropyl)amino]-3,5-dinitro-o-
toluic acid'. All of these degradates were ring rearrangements of
parent pendimethalin.
The half-lives for aerobic soil metabolism ranged from 42-563
days in the literature studies referenced below with a guideline study
reporting a half-life of 1322 days for a total of 27 total observations.
Because of the range of values, statistical analyses of the available
data were performed. The mean, median, and modal half-lives are
126, 122, and 122 days, respectively, with a standard deviation of 66
days (n=24). The half-life values of 409, 563, and 1322 days were
not included in the final statistical analyses because they were greater -
than three standard deviations from the mean. Based on soils and
crops that are normally treated with pendimethalin, the reviewer
assumed that temperatures would likely range from 20-30ฐC and soil
moisture contents from 50-75% Field Capacity (FC). The range of
observed half-lives in the above experimental conditions were 72-172
days. The 172-day half-life was used for GENeric Expected
Environmental Concentration Program (GENEEC) calculations since
it was the longest half-life for the observed range. Although some of
the studies were conducted using foreign soils, the half-lives for
62
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foreign soils fall within the range of values seen in studies using U.S.
soils. Guideline. 162-1, MRID 40185104.
Half lives were affected by study conditions. Walker and Bond
(1977) evaluated the effect of moisture, temperature and different
soils on soil persistence.
As indicated in Table 24, persistence decreased about 5 days for
every one percent increase in moisture.
Table 24. Calculated Half-Lives of Parent Pendimethalin in Sheeps
Pen Loam Soil (1.2% PC, 18.3% clay) at 25ฐC (Walker and Bond, 1977).
% Moisture (Field Capacity,FC)
12.5
25
37.5
50
62.5
75
Half-Life (days)
563
261
225
239
166
122
As indicated in Table 25 below, persistence decreased about 15 days for every degree of
temperature increase.
Table 25. Calculated Half-Lives of Parent Pendimethalin in Sheeps Pen Loam Soil (1.2 %
PC, 18.3 % clay) at 75 % Field Capacity (Walker and Bond, 1977).
Temperature <ฐC)
30
25
20
15
10
Half-life (days)
98
122
168
265
409
As indicated in Table 26 below, the persistence of pendimethalin generally increased with
increasing soil organic carbon and clay content.
63
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Table 26. Half-Lives of Parent Pendimethalin in Different Soils at 25ฐC and 75% FC (Walker
and Bond, 1977).
Soil '
Soakwaters
Gravel Pits
Gallas Leys
Big Cherry
Pump Ground
Water Meadows
%OC
0.87%
1.08%
1.12%
1.2%
1.33%
1.75%
6.8%
% clay
27.6%
20.4%
37.8%-
18%
20%
20.5%
60.4%
Half-life (days)
72
87
132
129
139
127
172
* Incomplete soil characterization information was provided.
Table 27 below reports aerobic soil metabolism half-lives.
Table 27. Calculated Half-Lives of Parent Pendimethalin in Different Soils (Zimdahl, et al.,
1984).
Soil
Clay loam
Clay loam
Clav loam
Clay loam
Clay loam
Clay loam
Clay
Sandy loom
%OC
0.76%
0.76%
0.76%
0.76%
0.76%
0.76%
1.0%
0.76%
%FC
50%
75%
75%
75%
75%
100%
75%
75%
Temperature (ฐC)
30
35
30
20
10
30
30
30
Half-Life (days)
73
61
54
77
101
56
42
45
As szhowsn in Table 27, persistence generally increased with
increasing clay and organic carbon content. The calculated half-lives
were 42-101 days in a range of soils with 0.76 and 1.0% Organic
Content (OC) at 50-100% Field Capacity (FC) and 10-35ฐC.
Persistence decreased with increasing moisture and temperature.
Anaerobic Soil Metabolism
Pendimethalin is stable to anaerobic soil metabolism. Ninety-
eight percent of parent remained after 60 days of anaerobic
conditions. The identified minor degradates were 2,6-dinitro-3,4-
xylidine, 4-[(l-ethylpropyl)amino]-2-methyl-3,5-dinitro benzyl
alcohol, and 4-[(l-ethylpropyl)amino]-3,5-dinitro-o-toluic acid. The
64
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guideline requirement is fulfilled (Guideline 162-2, MRID
40185105).
Anaerobic Aquatic Metabolism
The calculated half-lives were 6, 30, 33, 45, 52, 59, 62, 63, and
105 days.
A half-life of 105 days was calculated in silt loam soil (1.2% OC)
that was incubated for one week under aerobic conditions and for 8
weeks under anaerobic conditions. Only minor degradates (<2.5%)
were isolated; none were identified. Less than 3% was associated
with the flood water at any time in the study. (Guideline 162-3
MRID 40813501, reviewed on 6/27/91). ;
A half-life of 6 days was calculated for non-sterilized sandy loam
pond sediment from Ontario, Canada (1.8% organic carbon) at 25ฐC
incubated for 39 days under anaerobic aquatic conditions. In all
conditions (5ฐC non-sterile, 5ฐC sterile, 25ฐC non-sterile, and 25ฐC
sterile), aqueous residues decreased rapidly to form soil-extractable
residues, followed by a rapid increase in soil-bound residues. At 5ฐC
and 25ฐC under non-sterile conditions, aqueous residues declined to
about 11.8% by 16 days and remained constant until the end of the
study at 39 days. Extractable residues decreased from 60.8-70.9% at
5ฐC (non-sterile) to 27% by 39 days. Many minor (<10%) degradates
were isolated, and none were identified. Guideline. 162-3, MRID
43154702, reviewed for reregistration.
The calculated half-lives for 30 kilo pascals (kPa) (100% field
capacity), continuous flood, and alternate wet/dry treatments were 59,
63, and 30 days, respectively, in Crowley silt loam soil (5% sand,
74% silt, 21% clay, pH 5.5, 1% OC). Soil persistence decreased with
increasing soil moisture content. Alternating wet/dry conditions
decreased persistence presumably by increasing the volatility during
the wet cycle. Barrett and Lavy, 1983.
The calculated half-lives were 62, 52, 45, and 33 days in sterile,
non-flooded; non-sterile, non-flooded; sterile, flooded; and non-
sterile, flooded sandy loam soil with 60% sand, 21% silt, 19% clay,
0.35% OC, and pH 8.2. Persistence decreased with flooded
conditions regardless of sterility. Three minor degradates with ring
rearrangements were formed. Kulshrestha and Singh, 1992.
As reported in another study, between 45-59% of pendimethalin
was bound to sediment (Matapeake silt loam, pH 5.3, 0.87% organic
matter, 38.4% sand, 49.4% silt, and 12.2% clay) by 30 days. Only
65
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11-13% of residues were associated with the aqueous phase
throughout the study. Polar residues reached 54% by 2 days and
>90% by 9-30 days. A total of 32% of soil residues was extractable.
Isensee and Dubey, 1983.
The guideline requirement is fulfilled (Guideline-162-3, MRIDs
40813501,43154702).
(2) Mobility
Unaged Mobility (Batch Equilibrium)
Parent pendimethalin was essentially immobile in loamy sandy
(0.46% OC), sandy loam (0.93% OC), silt loam (2.73% OC), loam
(2.21% OC), and silty clay loam (2.91% OC), and sandy clay loam
(1.5% OC) soils from the U.S. with Freundlich Kads values of 30, 110,
380, 301, and 854, respectively. Desorption coefficients were not
provided. Kocads values were 15000, 13000, 14100, 13700, and
29400, respectively. The N values were 1.05, 1.08, 0.89, 1.20, and
0.83, respectively. The guideline requirement (Guideline 163-1) is
fulfilled. MRID 00153765
Parent pendimethalin was essentially immobile in loamy sandy
(0.87% OC), sandy loam (0.44% OC), sandy clay loam (0.67% OC),
and sandy clay loam (1.5% OC) soils from Japan with Freundlich Kads
values of 61, 193, 153, and 285, respectively. Freundlich Kdes values
were 124, 284, 323, and 556, respectively. Kooads values were 7011,
43863, 22835,'and 19000 and Kocdes values were 14252,-64545,
48208, and 37066, respectively. The N values ranged from 1.03-
1.13. Guideline 163-1, MRID 43041901
Aged Mobility
Waived for reregi strati on since there are no significant
transformation products of pendimethalin. Guideline 163-1.
Laboratory Volatility
Volatility can be significant under warm, moist conditions. The
maximum volatility rate for air-dried sandy loam soil (0.8% OC) was
5.4 x 10"5 /zg/cm2/hr and the maximum air concentration was 0.54
ug/m3. The maximum volatility rate for moist (80% FC) sandy loam
soil was 2.1 x 10'3 cm2/hr and the maximum air concentration was 31
ug/m3. The moist soil volatility rate and air concentration were
approximately 38 times and 57 times that of the dry soil
66
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(respectively). The guideline requirement (Guideline 163-2) is
fulfilled. MRID 00153766
Table 28. Volatility Half-lives (Walker and Bond, 1977).
Surface'
Bare Metal (aluminum)
Dry Sheeps Pen (1.2% OC, 18% clay)
Moist Sbeeps Pen (1.2% OC, 18% clay)
Half-life (days)
6
96
37
Incomplete soil characterization information was provided.
Volatilization of pendimethalin may be responsible for some of
the accelerated rate of loss as the soil moisture increases.
(3) Accumulation
Bioaccumulation in Fish
Pendimethalin residues accumulated in bluegill sunfish exposed
to 3 ppb of pendimethalin, with BCFs of 1400X for edible, 5800X for
non-edible, and 5100X for whole fish. Pendimethalin comprised 68-
81% of the recovered radioactivity, and the degradate 4-[(l-
ethylpropyl-amino]-2-methyl-3,5-dinitro-benzyl alcohol (CL
202,347) was 2-3.1% of the recovered radioactivity. Many other
minor degradates were formed, and totaled 32% of the applied
radioactivity. Depuration was rapid, with 87-91% of the 14C-residues
eliminated from the fish tissues by 14 days of depuration. The
guideline requirement is fulfilled (Guideline 165-4, MRJDs
00158235,00156726).
(4) Field Dissipation
Terrestrial Field Dissipation
No acceptable field dissipation studies were submitted for the
major crops treated with pendimethalin (cotton and soybeans). The
registrant should provide studies for these crops, since the orchard
study in CA is not necessarily representative of soybeans and cotton.
These studies can be modified to include volatility information.
The calculated half-life of pendimethalin in sandy loam soil in an
almond orchard in California was 34 days. No leaching was observed
below 6 inches of depth. Guideline 164-1, MRID 41722504
67
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Walker and Bond (1977) observed that volatilization occurred
more rapidly with warmer soil temperatures in English Sheeps Pen
and Big Ground soils. In the field, up to 50% volatilized in 30-40
days from the first surface application, and in 12-14 days from the
second surface application. Pendimethalin was lost more rapidly
from surface treatments than in incorporated treatments. When
incorporated, between 65-80% remained in field soil 20-23 weeks
after application. Walker and Bond, 1977.
The guideline requirement (164-1) is not fulfilled. Additional
studies are needed.
Aquatic Field Dissipation
. Aquatic field dissipation is unsatisfied at this time since no
acceptable study has been submitted to the agency. However, the
registrant has conducted an aquatic field dissipation study in dry-
seeded rice in Arkansas that has not yet been submitted. The
guideline requirement 164-2 is not fulfilled.
(5) Spray Drift
No pendimethalin specific studies were reviewed. Droplet size
spectrum (Guideline 201-1) and drift field evaluation (Guideline 202-
1) studies are required for pendimethalin, since the different
formulations may be applied by aircraft and it is estimated that there
will be detrimental effects to non-target terrestrial and semi-aquatic
plants due to drift. However, to satisfy these requirements the
registrant, in conjunction with other registrants of other pesticide
active ingredients, formed the Spray Drift Task Force (SDTF). The
SDTF has completed and submitted to the Agency its series of studies
which are intended to characterize spray droplet drift potential due to
various factors, including application methods, application
equipment, meteorological conditions, crop geometry, and droplet
characteristics. During 1997 the Agency plans to evaluate these
studies. In the interim, and for this assessment of pendimethalin, the
Agency is relying on previously submitted spray drift data and the
open literature for off-target drift rates. The estimated drift rates at
100 feet downwind of the treated sites are 1% at the applied spray
volume from ground applications and 5% from aerial applications.
After review of the new studies the Agency will determine whether a
reassessment is warranted of the potential risks of the application of
pendimethalin products.
68
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c. Water Resources
(1) Ground Water
The Agency concludes that pendimethalin has a low potential to
leach to ground water in most soils. Pendimethalin exceeds all of the
ground water persistence triggers, however, the high Kd and Koc
values demonstrate that pendimethalin will bind strongly to soil
organic matter and is not mobile. There is no indication that
pendimethalin would exceed any ground water LOG. Residues of
pendimethalin have been found in ground water in limited areas in
two states. The concentrations were relatively low, ranging from 0.2
to 0.9 ppb 0/g/L). However, considering its history of high use over
a wide geographic area on several major crops, there are relatively
few detections in ground water.
(2) Surface Water
Pendimethalin may contaminate surface water from spray drift
associated with aerial and ground spray application, or in runoff from
rainfall events and through irrigation waters (chemigation). Transport
of pendimethalin during runoff events which occur soon after
application could be considerable due to its persistence and extensive
use. The intermediate to high soil/water partitioning coefficients for
pendimethalin (Freundlich Kads of 30-854 ml/g; Kocs of 7011-64545)
indicate pendimethalin would be transported in runoff adsorbed onto
eroding soil or entrained sediment. The anaerobic aquatic
metabolism and soil mobility studies both reported partitioning of
pendimethalin primarily with the soil or sediment phase, and it is not
partitioned into the aqueous phase.
Surface waters may be contaminated through drift from aerial
and ground spray applications. Pendimethalin is aerially applied to
ป50% of the treated rice fields, <15% of the treated cotton acres, and
<5% for all other treated crops. Based on the environmental fate
assessment, volatilization losses of pendimethalin following aerial
applications may also be important. At this time, spray drift
information is unavailable; however, the registrant is a participating
member of the SDTF and data from the SDTF have been submitted
and are under review.
In receiving surface water bodies, pendimethalin is moderately
persistent (anaerobic aquatic metabolism half-life of 60 days).
Pendimethalin is stable to hydrolysis; however, it degrades by
aqueous photolysis (half-lives of 17-21 days) and should dissipate
fairly rapidly in shallow water exposed to sunlight. Volatilization of
69
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pendimethalin from well-mixed surface waters-may be an important
transport process because greater volatilization was observed under
moist field conditions (maximum of 50% volatilized from moist soils
in field studies) than for dry soils. The reported vapor pressure of 2.9
x W6 Torr at 20ฐC and estimated Henry's Law Constant of 2.2 x 10"s
atm-m^-mol"1 support the conclusion of volatility as a significant
transport mechanism.
Pendimethalin is not regulated under the Safe Drinking Water
Act (SDWA); therefore, a Maximum Contaminant Level (MCL) has
not been established for it. Pendimethalin is classified in Toxicity
Category HI based on the Oral LDSO from a rat study and has been
classified as a Group C nonquantifiable carcinogen by the HED
Carcinogenicity Peer Review Committee.
Monitoring Data
Baker (1988) studied sediment, nutrient, and pesticide transport
in selected Lower Great Lake Tributaries during 1982-1985.
Pendimethalin was detected in surface water samples from numerous
river transport stations. Maximum concentrations of pendimethalin
were 3.66 /zg/L (Upper Honey Creek) for 1983; 1.25 pgfL (Honey
Creek) for 1984, and 0.31 //g/L (Lost Creek) for 1985. The
maximum concentrations for pendimethalin in stream water samples
for selected Lower Great Lakes Tributaries are summarized in Table
29 (Baker, 1988).
Table 29. Maximum Concentrations of Pendimethalin for 1982-1985 (Baker, 1988)
SAMPLING
LOCATION
Rock Creek
II. Honey Creek
Cuy&hogft River
1982
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
1983 (/xg/L)
0.269
0.371
0.623
0.470
3.660
3.455
0.333
1.057
1984fcg/L)
. 0.666
0.570
1.248
0.276
0.055
0.346
0.080
0.139
1985 0*g/L)
0.0
0.130
0.230
0.0
0.0
0.310
0.0
0.0
Note: data for 1984 and 1985 were corrected for recoveries less than 100%.
In a study of the spatial and temporal distributions of pesticides
and nutrients in the Mississippi River and its tributaries, Coupe et al.
(1993) did not detect dissolved pendimethalin in surface water
70
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samples above the reporting limit of 0.018 jug/L. These study results
suggest pendimethalin would not be present in public drinking water.
The sampling period was April, 1991 to September, 1992 for eight
sampling stations (three on the Mississippi, and one each on the Ohio,
Illinois, Missouri, Platte, and White Rivers). The USGS study
focused on selected pesticides associated with agriculture row crop
production and employed extensive field and laboratory quality
assurance procedures to generate high-quality monitoring data.
A summary of the pendimethalin detections in the STORET
database are shown in Table 30. The surface water monitoring results
found in the STORET database are a compilation of various states'
monitoring data. The STORET data does not have strict quality
assurance criteria. The maximum.concentration of pendimethalin was
17.6 fj.g/L (ppb) for a surface water sample collected in Ohio; the next
highest reported concentration was 10 /ug/L with a range of 1-10
A*g/L. From the STORET data (excluding the highest Ohio sampling
results), the maximum concentrations of pendimethalin in surface
water samples range from 0.01 to 3.2 /ug/L.
ป
Table 30. Summary of Pendimethalin Detections in STORET database
STATE
AR
CA
CO
CT
KS
LA '
NE
OH
OR
PA
TX
WA
WI
MONITORING PERIOD
1995
1992-94
1993-94
1993-94
1993
1995
1992-93
1981-87
1992-95
1993-95
1995
1993-94
1993-94
DETECTIONS/
SAMPLES
12/35
20/291
32/92
2/2
1/1
2/2
17/71
650/2436
8/64
56/207
1/1
26/81
16/122
MAXIMUM
CONCENTRATION
~!4!gfL-
0.08
0.30
3.2
0.12
0.01
0.06
0.07
. 17.6
0.25
0.24
0.04
0.19
0.05
71
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3.
Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
Explanation of the Risk Quotient (RQ) and the Level of Concern
(LOC): The Levels of Concern are criteria used to indicate potential risk to
nontarget organisms. The criteria indicate that a chemical, when used as
directed, has the potential to cause undesirable effects on nontarget
organisms. There are two general categories of LOC (acute and chronic)
for each of the four nontarget faunal groups and one category (acute) for
each of two nontarget floral groups. In order to determine if an LOC has
been exceeded, a risk quotient must be derived and compared to the LOCs.
A risk quotient is calculated by dividing an appropriate exposure estimate,
e.g. the estimated environmental concentration (EEC), by an appropriate
toxicity test effect level, e.g. the LC50. The acute effect levels typically are:
-EC2S (terrestrial plants),
-EC50 (aquatic plants and invertebrates),
-LC50 (fish and birds)j and
-LD50 (birds and mammals)
The chronic test results are the:
-NOEL (sometimes referred to as the NOEC) for avian and mammal
reproduction studies, and either the NOEL for chronic aquatic studies, or
the Maximum Allowable Toxicant Concentration (MATC) which is the
geometric mean of the NOEL and the LOEL (sometimes referred to as the
LOEC) for chronic aquatic studies.
When the risk quotient exceeds the LOC for a particular category,
risk to that particular category is presumed to exist. Risk presumptions are
presented along with the corresponding LOC's.
Levels of Concern (LOC) and associated Risk Presumption
Mammals, Birds
IF TEE LOC
acute RQ> 0.5
acute RQ> 0.2
acute RQ> 0.1
chronic RQ> 1
acutely
PRESUMPTION
Potentially high acute risk
Risk that may be mitigated through
restricted use
Endangered species may be affected
f
Chronic risk, endangered species maybe
affected chronically
72
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Fish, Aquatic invertebrates
IF THE LOG PRESUMPTION
acute RQ> 0.5 Potentially high acute risk
acute RQ> 0.1 Risk that may be mitigated through
restricted use
acute RQ> 0.05 Endangered species may be affected
acutely
chronic RQ> 1 Chronic risk, endangered species may be
affected chronically
Plants
IF THE
LOG
1
RQ>
RQ (using the NOEC or
EC05)> 1
PRESUMPTION
Potentially high risk
Endangered plants may be affected
Currently, there are no separate criteria for restricted use or chronic effects for plants.
Pendimethalin use patterns addressed in risk assessmentPendimethalin is used on
a wide variety of agricultural crops as well as many non-agricultural use sites. The
following application rates and use patterns were assessed. These were based on labels
and registrant information:
Terrestrial Animals and Terrestrial and Semi-aquatic PlantsThe majority of use
sites have a maximum use rate of 2.0 Ibs ai/A or less. This includes such sites as corn,
cotton, beans, grain sorghum, peanuts (1 Ib ai/A), soybeans, rice (1 Ib ai/A) and some
others. These use sites make up over 90% of pendimethalin usage based on pounds
applied annually. Risk based on this rate is considered to be typical for pendimethalin.
However, there are some use sites that have higher single application rates and higher
maximum seasonal rates. Although these make up less than 10% of pendimethalin usage,
they still represent several million pounds of ai applied annually. These include:
Turf (max. single = 3 Ib ai/A, max. seasonal = 5 Ibs ai/A),
Onions (max. single = 2 Ibs ai/A, max. seasonal = 6 Ibs ai/A),
Sugarcane (max. single = 4 Ibs ai/A, max. seasonal = 6 Ibs ai/A) and
Ornamentals, landscape sites, non-cropland and alfalfa grown for seed (max.
single = 4 Ibs ai/A, max. seasonal = 4 Ibs ai/A).
Aquatic Animals and Plants Aquatic EECs were calculated using GENEEC
for the following use rates and patterns
1) 1.0 Ib ai/A - typical application rate applied once on a variety of agricultural
crops including cotton, corn, and soybeans, both ground and aerial,
73
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2) 2.0 Ibs ai/A - maximum single application rate for cotton, soybeans, corn
and other use patterns having a maximum application rate of 2 Ibs ai/A, both ground
and aerial,
3) 1.0 Ibs ai/A - typical application rate for cotton, applied twice, with a two
week application interval, both ground and aerial application,
4) 4 Ibs ai/A for alfalfa grown for seed and sugarcane, applied once per season,
both ground and aerial application, and
5) 2 Ibs ai/A for onions applied 3 times per season at two week intervals, both
ground and aerial application.
Aquatic EECs were not estimated for rice (1.0 Ib ai/A), turf, ornamental,
landscape &* grounds maintenance, non-cropland, and nonbearing nuts and vines (use
rates of 3 and 4 Ibs ai/A, ground application only). GENEEC is a model designed
specifically to model runoff from certain agricultural fields and the risk assessment
team did not consider it appropriate for sites such as these. It is assumed, for
assessment purposes, that exposure from these use patterns would not be higher than
exposure from other uses where GENEEC was used to estimate exposure. Exposure
from the rice use is not expected to be greater than from the cotton use at 1.0 Ib ai/A.
Rationale for this is provided in Section (4) Environmental Risk Characterization.
(1) Exposure and Risk to Nontarget Terrestrial Animals
(a) Birds
Residues found on dietary food items following application are
compared to LC50 values to predict hazard to birds. Day 0 residues on
vegetation were estimated based on the work of Hoerger and Kenaga
(1972) as modified by Fletcher et al. (1994) for application rates of 4.0 Ibs,
3.0 Ibs and 2.0 Ibs ai/A. For cotton (1.0 Ib ai/A), the highest (peak)
residues after the second application were estimated using a computerized
dissipation program that calculates daily estimated residues after repeated
applications and first-order dissipation kinetics at an assumed rate. The use
rate per application is 1.0 Ib ai/A with a between application interval of two
weeks (14 days), during which time the residues from the first application
would partially degrade. The aqueous photolysis half-life of 21 days was
used to estimate the degradation of pendimethalin on vegetation.
The predicted 0 day maximum pf pendimethalin that may be expected
to occur on different avian food items following various applications of
pendimethalin, and their corresponding risk quotients, are presented in the
table below:
74
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Table 31: Estimated Environmental Concentrations and Dietary Risk Quotients for
Birds (Based on anLCsn = 4,187 ppm)
Avian Food items
Short Grasses
Long Grasses
Broadleaf Plants and
insects
Fruits and pods
EEC-
ppm
4.0 Ibs
ai/A
960
440
540
60
RQ
Acute
0.2
0.1
0.1
<0.1
EEC-
ppm
3.0 Ibs
ai/A
720
330
405
45
RQ
Acute
t).2
0.08
0.1
<0.1
EEC-
ppm
2.0
Ibs
480
220
270
30
RQ
Acute
0.1
<0.1
<0.4
<0.1
EEC-
ppm
1.0
Ibs
391
180
220
24
RQ
Acute
<0.1
<0.1
<0.1
<0.1
Pendimethalin has low acute toxicity to birds, therefore, the risk
quotients are small. The LOG for endangered species (0.1) has been
slightly exceeded for the turf use (3.0 application rate) and smaller acreage
use sites (4.0 Ibs ai/A). Therefore, there is the potential that endangered
species may be affected, specifically grazers. The risk quotients at 3.0 and
4.0 Ibs ai/A are approximate to the restricted use LOG (0.2). However, the
use of pendimethalin is expected to pose minimal overall acute risk to avian
species, as further described in Section 4 Environmental Risk
Characterizati on.
Chronic risk to avian species cannot be determined at this time due to
lack of data.
(b) Mammals
Mammals are assumed to be exposed to dietary residues similar to birds.
The EEC's calculated in Table 22 will be used to estimate exposure to
mammals.
Small mammal acute risk is usually addressed using acute oral LD50
values converted to estimate an LCSO value for comparison with dietary
exposure. However, in the case of pendimethalin, it was determined that
the 2-generation reproductive toxicity study with rats which reported no
mortality at 2500 ppm (NOEL for acute and subacute effects) was a better
indicator of potential for acute toxicity from dietary exposure. The
maximum estimated concentration on mammalian food items is 960 ppm.
Because the maximum EEC is much less than the NOEL, where no effects,
either sublethal or lethal, occurred, it is unlikely that mammals, including
endangered mammal species, would be exposed to enough pendimethalin
to cause adverse effects.
75
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Based on the same 2-generation reproductive toxicity study in rats,
minimal chronic risk to mammalian species, including endangered species,
is expected. The NOEL of 2500 ppm is much higher than the maximum
EECof960ppm.
(c) Insects
Pendimethalin is practically non-toxic to honeybees. Honeybees are not
likely to be adversely affected by the use of pendimethalin.
(2) Exposure and Risk to Nontarget Aquatic Animals
Expected Aquatic Concentrations: The Agency calculated Generic
Estimated Environmental Concentrations (GEECs) for pendimethalin
application to a variety of crops'at several different rates and application
patterns. These GEECs are designed as a coarse screen and depend on
basic chemical parameters and pesticide label application information. The
GENeric Expected Environmental Concentration Program (GENEEC)
which was used to calculate the GEECs is a Tier I model which uses a
chemical's soil/water partition coefficient and degradation half-life values
to estimate runoff from a ten hectare field into a one hectare by two meter
deep pond. GENEEC was designed to specifically model runoff from
agricultural fields.
GENEEC calculates both acute and chronic generic EEC values. It
considers reduction in dissolved pesticide concentration due to adsorption
of pesticide to soil or sediment, incorporation, degradation in soil before
washoff to a water body, direct deposition of spray drift into the water
body, and degradation of the pesticide within the water body. Review of the
Spray Drift Task Force data has not been completed, so spray drift is
assumed to be 1% of the application rate for ground applications and 5% of
the application rate for aerial applications.
The following values were used for input into the GENEEC program:
Soil organic carbon partitioning coefficient:
Soil aerobic metabolic half-life
Hydrolysis half-life:
Photolysis half-life:
Aquatic aerobic metabolic half-life
Water solubility:
7011
172 days
Stable
Stable
Stable
375 ppb
76
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Table 32: Generic EECs for Pendimethalin
Crop
Soybeans, Cotton, Corn
Soybeans, Cotton, Corn
Soybeans, Cotton, Corn
Soybeans, Cotton, Corn
Cotton
Cotton
Sugarcane, Alfalfa
(grown for seed)
Sugarcane, Alfalfa
(grown for seed)
Onions
Onions
Application
Method
Broadcast -
ground
Aerial
Broadcast -
ground
Aerial
Broadcast -
ground
Aerial
Broadcast-
ground
Aerial
Broadcast -
ground
Aerial
Application
Rate in Ibs a.i./A
(number of apps.)
1.0(1) typical rate
1.0 (1) typical rate
2.0 (1) maximum rate
2.0 (1) maximum rate
1.0 (2) typical rate - 2 week
application interval
1.0 (2) typical rate - 2 week
application interval
4.0 (1) maximurp rate
4.0 (1) maximum rate
2.0 (3) maximum rate - 2 week
application interval
2.0 (3) maximum rate - 2 week
application interval
Peak EEC
(Ppb)
3
5
7
10
7
10
13
19
20
31
4-day
EEC
(Ppb)
3
4
6
8
6
9
12
17
17
27
21-day
EEC
(Ppb)
2
2
3
4
3
5
6
9
9
14
56-day
EEC
(EgbJ
1
1
2
3
2
3
4
5
6
9
Peak exposure levels range from 3 to 31 ppb (/tg/L), with 56-day
average values ranging from 1 to 9 ppb (//g/L).
Since one application at 2.0 Ibs ai/A yielded essentially the same GEEC
as that from two applications at 1.0 Ib ai/A, both of these scenarios will be
combined in the risk quotient tables.
77
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(a) Freshwater Fish
Table 33: Acute Risk Quotients (RQ) for Freshwater Fish based on Testing with Technical
Pendimethalin
Crop and application method
Soybeans. Cotton and Corn - ground
Soybeans. Cotton and Corn - aerial
Soybeans. Cotton and Corn - ground
Soybeans. Cotton and Corn - aerial
Sugarcane. Alfalfa - ground ,
Sugarcane. Alfalfa- aerial
Onions - ground
Onions - aerial
Application
Rate in Ibs a.i./A
(number of apps.)
1.0(1) -typical
1.0(1) -typical
2.0 (1) - maximum rate
2.0 (1) - maximum rate
4.0 (1) - maximum rate
4.0 (1) - maximum rate
2.0 (3) - maximum rate
14 day appl. interval
2.0 (3) - maximum rate
14 day appl. interval
Peak
EEC
(ppb)
3
5
7
10
13
19'
20
31
Species
Rainbow
trout
96 hour
LCM
(ppb)
138
Acute
RQ
0.02
0.04
0.05 I
0.0^^1
0.09
0.1^^
0.14
0.22
Acute
The majority of pendimethalin use is represented by the 1.0 and 2.0 Ib
ai/A application rates. At the typical rate of 1.0 Ib ai/A, no LOCs are
exceeded. This suggests fish are not typically at acute risk from
pendimethalin.
When using maximum application rates, all use patterns except 2.0 Ibs
ai/A, ground application, result in acute risk quotients for fish that exceed
the endangered species LOG (0.05). Thus, pendimethalin may affect
endangered fish species under these conditions.
Use patterns involving higher application rates such as sugarcane and
alfalfa and onions result in acute risk quotients for fish that exceed the
restricted use LOG (0.1) by a small margin.
The Agency assumes that aquatic risk from turf (1.5 to 3.0 Ibs ai/A,
label indicates ground application only) and landscaping, ornamentals and
non-cropland (2.0 to 4.0 Ibs ai/A, label indicates ground application only)
are not higher that risk from other "ground application" use patterns with
similar application rates. Therefore, it is assumed turf, landscaping,
ornamentals and noncropland could affect endangered fish species but
would not exceed the restricted use LOG.
78
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Aquatic EECs were not estimated for rice since GENEEC was not
designed to estimate aquatic exposure from this use pattern. Aquatic risk
from rice (1.0 Ib ai/A) is expected to be less than from the cotton use at 1.0
Ib ai/acre as discussed in the Environmental Risk Characterization Section.
None of the use patterns for pendimethalin result in acute risk quotients
for fish that exceed 0.5. Thus, high acute risk to fish is unlikely.
Chronic
Based on the MATC from the fathead minnow full life-cycle study 7.85
ppb (Mg/L) and the 56-day average GEECs, most use sites represent
minimal chronic risk to fish.
The 56-day average GEEC for Onions (4.0 Ibs ai/acre, aerial), 9 ppb
), exceeds the MATC by a small margin indicating potential for
chronic risk to fish.
Turf, landscape, ornamental, non-cropland and rice uses are expected to
result in minimal chronic risk to fish.
(b) Freshwater Invertebrates
Table 34: Acute Risk Quotients (RQ) for Freshwater Aquatic Invertebrates based on
Testing with Technical Pendimethalin
Crop and application method
Soybeans, Cotton and Corn - ground
Soybeans, Cotton and Corn - aerial
Soybeans, Cotton and Corn - ground
Soybeans, Cotton and Corn - aerial
Sugarcane, Alfalfa - ground
Sugarcane, Alfalfa - aerial
Onions - ground
Onions - aerial
Application
Rate in Ibs a.i./A
(number of apps.)
1.0(1) -typical rate
1.0 (H - typical rate
2.0 (1) - maximum rate
2.0 (1) - maximum rate
4.0 (1) - maximum rate
4.0 (1) - maximum rate
2.0 (3) - maximum rate
14 day appl. interval
2.0 (3) - maximum rate
14 day appl. interval
Peak
EEC
(Ppb)
3
5
7
10
13
19
20
31
Species
Daphnia
magna
96 hour
IA,
(Ppb)
280
Acute
RQ
0.01
J1.02
0.02
0.04
0.05
0ฃ7^
0.07
0.11
Acute
Use patterns such as cotton, corn and soybeans involving an application
rate of 1.0 to 2.0 Ibs ai/A (aerial or ground) do not result in acute risk
quotients for aquatic invertebrates that exceed any LOCs. These use
patterns represent minimal acute risk to aquatic invertebrates.
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Sugarcane and alfalfa, when treated by aerial equipment at 4 Ibs ai/A
and onions when treated three times at 2.0 Ibs ai/A result in acute risk
quotients for aquatic invertebrates that exceed the endangered species LOG
(0.05) by a small margin.
Aerial application to onions (three times at 2.0 Ibs ai/A) results in acute
risk that exceeds the restricted use LOG (0.1) by a small margin.
The Agency assumes that aquatic risk from turf (1.5 to 3.0 Ibs ai/A,
label indicates ground application only) and ornamentals and non-cropland
(2.0 to 4.0 Ibs ai/A, label indicates ground application only) are not greater
than risk from other use patterns with similar application rates. Therefore,
it is assumed these use patterns may affect endangered aquatic invertebrates
but would not be expected to exceed the restricted use LOG.
Aquatic EECs were not estimated for rice since GENEEC was not
designed to estimate aquatic exposure from this use pattern. Aquatic risk
from rice (1.0 Ib ai/A) is expected to be less than from the cotton use at 1.0
Ib ai/A as discussed in the Environmental Risk Characterization Section.
The rice use does not exceed the aquatic invertebrate endangered species
LOG.
None of the use patterns for pendimethalin result in acute risk quotients
that exceed 0.5. Thus, high acute risk to aquatic invertebrates is unlikely.
Chronic
Based on the aquatic invertebrate MATC from the Daphniamagna life-
cycle, study 23 ppb 0/g/L) and 21-day average Generic EECs, the use of
pendimethalin represents minimal chronic risk to aquatic invertebrates.
Turf, landscape, ornamental, non-cropland, and rice uses are expected to
result in minimal chronic risk to aquatic invertebrates.
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(c) Estuarine and Marine Animals
Table 35: Acute Risk Quotients (RQ) for Eastern Oyster based on Testing with Technical
Pendimethalin
Crop and application method
Soybeans, Cotton and Corn - ground
Soybeans, Cotton and Corn - aerial
Soybeans, Cotton and Corn - ground
Soybeans, Cotton and Corn - aerial
Sugarcane, Alfalfa - ground
Sugarcane, Alfalfa - aerial
Onions - ground
Onions - aerial
Application
Rate in Ibs a.i./A
(number of apps.)
1.0 (1) - typical rate
1.0(1) -typical rate
2.0 (1) - maximum rate
2.0 (1) - maximum rate
4.0 (1) - maximum rate
4.0 (1) - maximum rate
2.0 (3) - maximum rate
14 day appl. interval
2.0 (3) - maximum rate
14 day appl. interval
Peak
EEC
(ppb)
3
4
7
10
13
19
20
31
Species
Eastern
oyster
48-hour
ECM
(ppb)
210
Acute
RQ
0.01
0.02
0.03
0.05
muumma
0.06
0.09
0.09
0.14
Acute
Risk quotients shown are only for the eastern oyster, which had the
lowest EC50 of the three estuarine species tested. Risk quotients using the
acute toxicity for shrimp and fish would not have exceeded any LOCs.
Minimal acute risk to shrimp and estuarine fish is expected from all
pendimethalin uses.
Use patterns such as cotton, corn and soybeans involving an application
rate of 1.0 to 2.0 Ibs ai/A (aerial or ground) do not result in risk quotients
for oysters that exceed any LOCs. These use patterns represent minimal
acute risk to estuarine species.
Sugarcane and alfalfa, when treated by air at 4 Ibs ai/A and onions when
treated three times at 2.0 Ibs ai/A result in acute risk quotients for oysters
that exceed the endangered species LOG (0.05) by a small margin.
Aerial application to onions (three times at 2.0 Ibs ai/A) results in acute
risk quotients that exceed the restricted use LOG (0.1) by a small margin.
The Agency assumes that aquatic risk from turf (1.5 to 3.0 Ibs ai/A,
label indicates ground application only) and ornamentals and non-cropland
(2.0 to 4.0 Ibs ai/A, label indicates ground application only) are not greater
than risk from other use patterns with similar application rates. Therefore,
81
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these use patterns may effect endangered mollusk species but would not be
expected to exceed the restricted use LOG.
Aquatic EECs were not estimated for rice since GENEEC was not
designed to estimate aquatic exposure from this use pattern. Aquatic risk
from rice (1.0 Ib ai/A) is expected to be less than from the cotton use at 1.0
Ib ai/A as discussed in the Environmental Risk Characterization Section.
None of the use patterns for pendimethalin result in acute risk quotients
that exceed 0.5. Thus, high acute risk to estuarine fish or invertebrates is
unlikely.
Chronic
No chronic data with estuarine species were reviewed.
(3) Exposure and Risk to Nontarget Plants
(a) Terrestrial and Semi-Aquatic
The Agency does separate risk assessments for nontarget terrestrial and
semi-aquatic plants. Nontarget terrestrial plants inhabit non-aquatic areas
which are generally well drained. Nontarget semi-aquatic plants inhabit
low-lying areas that are usually wet, although they .may be dry during
certain times of the year. Semi-aquatic plants are not obligatory aquatic
plants in that they do not live in a continuously aquatic environment. Both
the terrestrial and semi-aquatic plants are exposed to pesticides from runoff
and drift. They differ, however, in that terrestrial plants are assumed to be
exposed via sheet runoff, whereas semi-aquatic plants are assumed to be
exposed via channelized runoff. Calculating runoff exposure is done using
a simple model which assumes that a certain percent of that which is
applied transports with run off. The percent is based on solubility. Since
the solubility is 0.375 ppm, it is assumed no more than 1% of the applied
pendimethalin would runoff. Drift from aerial applications is assumed to
be 5%, while drift from ground applications would not be expected to
'exceed 1% of the applied.
Volatilization is also a potential route of exposure, however ecological
risk assessment techniques are not currently available to determine risk
from such exposure.
Nonendangered Terrestrial and Semi-aquatic Plants
Risk quotients for terrestrial and semi-aquatic plants are derived by
dividing an exposure estimate, in Ib ai/A, by an EC25, also expressed in Ib
ai/A. The total loading rate (runoff plus spray drift) is used with the EC25 of
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the most sensitive species in the seedling emergence study to determine the
risk quotient for exposure to emerging seedlings. The loading from spray
drift alone is used with the EC2S value of the most sensitive species in the
vegetative vigor study to determine the risk to adult plants from foliar
exposure.
The following table outlines the acute risk quotients to terrestrial and
semi-aquatic plants using results from toxicity testing with technical
pendimethalin.
Table 36: Exposure and Risk Quotients for Terrestrial and Semi-aquatic Plants
Application
scenario & rate
Ground, 2.0 Ibai/A
(corn, soybeans and
cotton, onions*.)
Aerial, 2.0 Ibai/A
(corn, soybeans and
cotton, onions*)
Ground, 3 Ib ai/A
(turf)
Ground, 4 Ib ai/A
(Ornamentals,
landscape sites, non-
cropland,
nonbearing nuts and
vines, alfalfa grown
for seed, sugarcane)
Plant type
Terrestrial
Semi-aquatic
Terrestrial &
semi-aquatic
Terrestrial
Semi-aquatic
Terrestrial &
semi-aquatic
Terrestrial
Semi-aquatic
Terrestrial &
semi-aquatic
Terrestrial
Semi-aquatic
Terrestrial &
semi-aquatic
Exposure
. scenario
Sheet runoff +
spray drift
(1%)
Channelized
runoff + spray
drift (1 %)
Spray drift
(1%)
Sheet runoff +
spray drift
(5%)
Channelized
runoff + spray
drift (5%)
Spray drift
(5%)
Sheet runoff +
spray drift
(1%)
Channelized
runoff + spray
drjft (1 %)
Spray drift
(1%)
Sheet runoff +
spray drift
(1%)
Channelized
runoff + spray
drift (1 %)
Spray drift
(1%)
Exposure (Ib
ai/A)
0.04
0.22
0.02
0.12
0.30
0.10
0.06
0.33
0.03
0.08
0.44
0.04
ECjj (Ib ai/A)
0.02 (seedling
emergence)
0.02 (seedling
emergence)
0.035 (veg.
vigor)
0.02 (seedling
emergence)
0.02 (seedling
emergence)
0.035 (veg. .
vigor)
0.02 (seedling
emergence)
0.02 (seedling
emergence)
0.035 (veg.
vigor)
0.02 (seedling
emergence)
0.02 (seedling
emergence)
0.035 (veg.
vigor)
Risk
Quotient
2
11
<1
6
15
2.8
3
16.5
<1
4
22
1
83
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Application
scenario & rate
Aerial, 4 Ibai/A
(alfalfa grown for
seed, sugarcane)
Plant type
Terrestrial
Semi-aquatic
Terrestrial &
semi-aquatic
Exposure
scenario
Sheet runoff +
spray drift
(5%)
Channelized
runoff + spray
drift (5 %)
Spray drift
(5%)
Exposure (Ib
ai/A)
0.24
0.60
0.20
ECjS (Ib ai/A)
0.02 (seedling
emergence)
0.02 (seedling
emergence)
0.035 (veg.
vigor)
Risk
Quotient
12
30
6
Cotton and onion use involves multiple applications, however, the modiel used to estimate exposure does not handle multiple
applications well. It is expected that the risk numbers could be higher with more applications at 2 Ibs ai/A.
The LOG (1) for risk to terrestrial and semi-aquatic plant species has
been exceeded for both ground and aerial application. This indicates that
pendimethalin poses a risk to the vegetative vigor and emergence of
nontarget terrestrial and semi-aquatic plants.
Endangered Terrestrial and Semi-aquatic Plants
Risk quotients for endangered terrestrial and semi-aquatic plants are
derived by dividing an exposure estimate, in Ib ai/A, by an NOEC, also
expressed in Ib ai/A. The lowest NOEC for terrestrial' plants is 0.01 Ib ai/A
(ryegrass, seedling emergence). The risk quotients for endangered plants
based on this NOEC compared to the range of exposures predicted would
be from 4 to 60. This indicates that pendimethalin may affect threatened
and endangered terrestrial and semi-aquatic plants.
(b) Aquatic
The same aquatic exposure values used to estimate risk to fish and
invertebrates will be used to estimate risk to aquatic plants.
Nonendangered Aquatic Plants
Risk quotients for nonendangered plants are calculated for aquatic plants by
dividing the GEEC by the aquatic plant EC50 values. A risk quotient for
aquatic vascular plants is based on the EC50 of 12.5 ppb (A*g/L) for
duckweed (Lemna gibbd). A risk quotient for nonvascular aquatic plants is
based on the most sensitive algal or diatom species tested. For
pendimethalin, the most sensitive nonvascular plant tested was the marine
diatom Skeletonema costatum with an EC50 of 5.2 ppb
The following table outlines the risk quotients for nonendangered
aquatic plants using results from toxi city testing with technical
pendimethalin.
84
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Table 37: Risk Quotients (RQ) for Vascular Aquatic Plants
Crop and application method
Soybeans, Cotton and Corn - ground
Soybeans, Cotton and Corn - aerial
Soybeans, Cotton and Corn - ground
Soybeans, Cotton and Corn - aerial
Sugarcane, Alfalfa - ground
Sugarcane, Alfalfa - aerial
Onions - ground
Onions - aerial
Application
Rate in Ibs a.i./A
(number of apps.)
1.0(1) -typical rate
1.0(1) -typical rate
2.0 (1) - maximum rate
2.0 (1) - maximum rate
4.0 (1) - maximum rate
4.0 (1) - maximum rate
2.0 (3) - maximum rate
14 day appl. interval
2.0 (3) - maximum rate
14 day appl. interval
Peak
EEC
(ppb)
3
5
7
10
13
19
20
31
Species
Lemna
gibba
EC
(ppb)
[NOEC]
12.5
[5.6]
RQs
[End
Spec]
0.2
[0.5]
0.4
0.6
[1.2]
0.8
1.0
(2.31
1.5
[3.41
ซi> *i "n
1.5
[3.6]
2.5
[551 '
Table 38: Risk Quotients (RQ) for non-vascular plants (representing algae and diatoms)
Crop and application method
Soybeans, Cotton and Corn - ground
Soybeans, Cotton and Corn - aerial
Soybeans, Cotton and Corn - ground
Soybeans, Cotton and Corn - aerial
Sugarcane, Alfalfa - ground
Sugarcane, Alfalfa - aerial
Onions - ground
Onions - aerial
Application
Rate in Ibs a.i./A
(number of apps.)
1.0(1) -typical rate
1.0(1) -typical rate
2.0 (1) - maximum rate
2.0 (1) - maximum rate
4.0 (1) - maximum rate
4.0 (1) - maximum rate
2.0 (3) - maximum rate
14 day appl. interval
2.0 (3) - maximum rate
14 day appl. interval
Peak
EEC
(ppb)
3
5
7
10
13
19
20
31
Species
Skele-
tonema
costatum
ECX
(PP^
[NOEC]
5.2
[0.7]
RQs
[End
Spec]
0.6
[4.31
0.1
1.3
[10.01
2.0
[14.3|
2.5
[18.61
3.6
t27.ll
3.8
(28.6)
6.0
[44.31
Typical application rates for many of the large acreage crops for which
pendimethalin is registered do not represent a risk to aquatic plants.
However, uses of pendimethalin at maximum rates are expected to result in
risk to aquatic plants for all sites.
85
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Endangered Aquatic Plants
Risk quotients for endangered aquatic plants are calculated by dividing
the GEEC by the aquatic plant NOEC or EC05 values. Risk quotients for
endangered aquatic plants are based on the NOEC of 5.6 ppb (//g/L) for
duckweed (Lemna gibbet) and the NOEC of 0.7 for Skeletonema costatum.
The risk quotients for endangered aquatic plants range from less than 1 (L.
gibba, soybeans, cotton and corn, 1.0 Ibs ai/A, ground) to a high of 44 (S.
costatum, onions, three applications of 2 Ibs ai/A, aerial). All uses of
pendimethalin may affect endangered aquatic plants.
(4) Endangered Species
The use of pendimethalin may adversely effect endangered species of
terrestrial and semi-aquatic plants, aquatic plants and invertebrates
including mollusks, fish, and birds (specifically grazers).
When the Endangered Species Protection Program becomes final,
limitations in the use of pendimethalin may 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 may 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.
b. Environmental Risk Characterization
Pendimethalin is a dinitroaniline herbicide registered for use on annual
grasses and broadleaf weeds in terrestrial food crop and terrestrial non-food
crop use groups. It is a cell growth inhibitor that prevents seedling
development and is herbicidally active on the roots and coleoptiles of
susceptible weeds. Pendimethalin does not control weeds postemergence and
must be soil applied. Formulations include a 3.3 emulsifiable concentrate, a
4.0 emulsifiable concentrate, a 60DG water dispersible granule, and a fertilizer
formulation. Application rates range from 1.0 to 4.0 Ibs ai/A. Total
pendimethalin use ranges from 14 to 25 million pounds active ingredient
annually, with the largest usage occurring on soybeans, cotton, and corn.
(1) Environmental Fate and Water Resources
Pendimethalin dissipates in the environment by binding to soil,
microbially-mediated metabolism, and volatilization. Persistence decreases
with increased temperature, increased moisture and decreased soil organic
86
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carbon. Pendimethalin forms many minor (<10% of applied) degradates.
Residues are tightly bound to soil particles and in aquatic environments,
pendimethalin and its degradates are primarily associated with the sediment
and not the aqueous phase. Pendimethalin accumulates readily in bluegill
sunfish, however, depuration is also rapid. Field dissipation studies on the
major use sites (cotton and soybeans) that would more clearly describe the
environmental fate of pendimethalin in the field have not been submitted
and are requested. The purpose of these studies is to determine the
dissipation routes of pendimethalin and the potential for off site effects
from its use.
Pendimethalin may contaminate surface water from spray drift
associated with aerial and ground spray application, or in runoff from
rainfall events and through irrigation waters (chemigation). Pendimethalin
is not regulated under the Safe Drinking Water Act (SDW A), therefore, an
MCL has not been established for it. Pendimethalin has been classified as a
Group C nonquantifiable carcinogen by the HED Carcinogenicity Peer
Review Committee (RCAB risk assessment summary, 1/17/96).
Pendimethalin has been detected in surface water samples at concentrations
of <0.01 ppb (Atg/L) to approximately 3 ppb (jJ-g/L), and two additional
higher values of 10 and 17.6 ppb Og/L). The high affinity for
pendimethalin to bind to soil and sediment particles, should limit
concentrations of pendimethalin in surface waters.
The high Kd and Koc values demonstrate that pendimethalin will bind
strongly to soil organic matter and is not mobile. The Agency concludes
that pendimethalin has a low potential to leach to ground water in most
soils. Pendimethalin has a history of high use over a wide geographic area
on several major crops, however the number of reported detections in
ground water is small and the concentrations are relatively low.
Pendimethalin residues in drinking water do not appear to be a human
health concern. Pendimethalin residues originating from ground water also
do not appear to be a concern to organisms such as aquatic plant, terrestrial
plants, birds, fish and most aquatic invertebrates. The potential for ground
water contamination from pendimethalin residues is low and the potential
risk from residues in drinking water is low.
(2) Risk to Nontarget Species
According to the registrant, the typical application rate for the major
uses of pendimethalin is 2 Ibs ai/A. Except for the avian chronic risk which
could not be determined, generally at this rate there is expected to be
minimal acute risk to birds, minimal acute and chronic risk to fish and
aquatic invertebrates, minimal acute risk to estuarine organisms and
moderate risk to plants. Use rates higher than 2 Ib ai/A are less than 10% or
87
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2,000,000 Ibs of pendimethalin total usage. These use rates did result in
some LOG exceedances.
Birds: The acute risk to birds from pendimethalin is low. The risk
quotients (RQs) do not exceed the levels of concern (LOCs) for potentially
high acute risk or restricted use. The avian endangered species LOG has
been slightly exceeded for the turf and other uses with application rates of
3.0 Ibs ai/A or higher. ,The slight exceedance (RQ of 0.2 compared to LOG
of 0.1) was based on the maximum residues from the application rates of
3.0 and 4.0 Ibs ai/A on short grasses. The species that may be affected
would be primarily grazers (e.g. geese).
The avian acute RQs from the 2 Ibs. ai/A rate do not exceed any LOCs.
Thus the typical usage of pendimethalin is considered to represent minimal
acute risk to birds.
Chronic risk to avian species cannot be determined because avian
reproduction studies have not been submitted. Avian reproduction studies
(preferably with the bobwhite quail and the mallard duck) are requested.
s Mammals: Both the acute and chronic risk to mammals, including
endangered species, is expected to be minimal. In a 2-generation
reproductive toxicity study in rats a NOEL of 2500 ppm was reported. This
NOEL is much higher than the maximum EEC of 960 ppm, therefore, it is
unlikely that animals would be exposed to pendimethalin residues high
enough to cause adverse effects.
Fish and Aquatic Invertebrates: The overall risk to nontarget aquatic
animals from pendimethalin is low.
Fish: The LOG for acute effects to endangered freshwater fish species
was equaled, or exceeded by small margins, by all use sites that are treated
aerially at 2 Ibs ai/A or higher (R.S. ranged from 0.05 to 0.22 compared to
the LOG of 0.05), indicating a possibility of effects. All use sites with
applications greater than 2.0 Ibs ai/A would exceed the endangered fish
LOG. A single ground application of pendimethalin at 2 Ibs ai/A or lower
would not exceed any loss and represents minimal acute risk to fish.
Application to rice (1.0 Ib ai/A) by either air or ground would not exceed
any fish LOCs.
Application to onions (three times at 2 Ibs ai/A) by air results in R.S.
that exceeds the restricted use LOG forfish.
The chronic risk LOG for fish was exceeded by a small margin (RQ of
1.1 compared to the LOG of 1) by aerial use of pendimethalin on onions.
This exceedance was based on the 56-day average GEEC of 9
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Pendimethalin use on onions is considered to represent a low chronic risk
to fish. All other use patterns represent minimal chronic risk to fish.
Freshwater invertebrates: Acute risk to freshwater aquatic invertebrates
tends to be lower than for fish since pendimethalin is less acutely toxic to
these organisms. Applications at 2 Ibs ai/A, whether by air or ground, did
not exceed any LOCs. Applications greater than 2 Ibs ai/A, or multiple
applications of 2 Ibs ai/A yielded RQs that exceeded the endangered
invertebrate LOG by a small margin indicating the possibility of effects to
endangered invertebrates, including mollusks. Aerial treatment of onions
(three applications at 2 Ibs ai/A) resulted in an RQ that exceeded the
restricted use LOG by a small margin (0.14 compared to an LOG of 0.1).
Chronic risk to freshwater aquatic invertebrates is expected to be
minimal since the chronic RQs did not exceed the LOG for chronic effects
for any uses.
Estuarine organisms: Pendimethalin represents minimal acute risk to
estuarine fish and shrimp. Based on toxicity to the eastern oyster, the
endangered species LOCs are exceeded by small margins (0.06 to 0.14
compared to and LOG of 0.05) from application rates greater than 2 Ibs
ai/A, or multiple applications at 2 Ibs ai/A. Currently, there are no
endangered estuarine species of mollusks.
Terrestrial and Semi-aquatic Plants: The risk to nontargetterrestrial.and
semi-aquatic plants is predicted to be moderate. The RQs are as high as 30
for emerging seedlings. The LOCs have been exceeded for both ground
and aerial applications based on the application rate of 2.0 to 4.0 Ibs ai/A.
This indicates that exposure to pendimethalin from runoff and spray drift
will pose risk to the emergence of nontarget plants. Spray drift from aerial
applications above 2 Ibs ai/A represent a risk to the vigor of mature plants
(RQ of 2.8 to 6 compared to LOG of 1). Pendimethalin may also affect
endangered terrestrial and semi-aquatic plant species.
Pendimethalin, because of its extensive usage, has the potential to exert
impact on a large area of nontarget flora. The potential risk would be
confined to areas around application sites, i.e. within the drift and runoff
zone. Offsite movement from volatilization may also result in risk to
plants, but the exposure levels could not be estimated.
It is also noteworthy that the magnitude of RQs, while exceeding the
LOG by sizeable margins, are not as high as for other herbicides. Thus, it is
presumed that pendimethalin represents a moderate risk to nontarget
terrestrial and semi-aquatic plants. This is a balance of LOG exceedances
that are not particularly high and extensive usage.
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Aquatic Plants: The LOG for risk to nontarget aquatic plants has been
exceeded. Risk may be a little higher for nonvascular aquatic plants
(diatoms and algae; RQs from 1.3 to 6) than for vascular plants (L. gibba;
RQs from 0.6 to 2.5). However, based on the magnitude of RQs, the
overall risk to aquatic plants is considered to be moderate.
(3) Additional Discussion on Aquatic Risk of Pendimethalin
Additional information on pendimethalin that affects the determination
of risk to aquatic organisms includes its tendency to bind to sediment and
suspended particulates, monitoring results, and typical application rates.
Because of its environmental fate characteristics, once pendimethalin
reaches surface water habitats, it will tend to bind to sediment and
suspended particulates. The strength of this binding increases with time as
is evidenced by the methods required to extract pendimethalin from soil or
sediment. This should limit long term concentrations in solution in surface
waters.
The presumption that concentrations in surface water systems are
limited is supported by monitoring results. In a study of the spatial and
temporal distributions of pesticides and nutrients in the Mississippi River
and its tributaries, Coupe et al. (1993) did not detect dissolved
pendimethalin in surface water samples above the reporting limit of Q.018
/zg/L. These study results suggest pendimethalin may not be present in the
aqueous phase in concentrations above 0.018 ppb (//g/L). In monitoring
reported by Baker (1988) from 1982 to 1985, the residues in Ohio creeks
and rivers did not exceed 3.6 ppb (j^g/L), and were typically less than 1 ppb
(/zg/L). The lowest toxicological endpoints for freshwater aquatic
organisms are the fish full life cycle MATC of 7.85 ppb O^g/L) and the
EC50 for Duckweed (Lemna gibba) of 12.5 ppb C/g/L). The reported
levels from monitoring do riot represent a high risk to aquatic organisms.
Finally, it is noted that while several use sites are labeled for use rates
greater than 2 IbS ai/A, the typical application rate for most sites is 2 Ibs
ai/A, according to the registrant. The exceptions are ornamentals (3.0 Ibs
ai/A), landscape and grounds maintenance, non-cropland (4.0 Ibs ai/A) and
a few agricultural crops that have higher seasonal rates (e.g. onions; 6 Ibs .
ai/A per season). According to the registrant information, less than
200,000 Ibs of pendimethalin are applied to these "higher application rate"
use sites annually. Thus, less than one percent of pendimethalin usage is
typically at rates greater than 2 Ibs ai/A.
Monitoring information indicates that pendimethalin residues are
present in surface water. However, the Agency concludes that these
concentrations do not represent a high risk to aquatic animals and plants,
including estuarine organisms.
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(4) Discussion of aquatic risk from other use sites for which
GENEEC was not used.
Rice: Although pendimethalin is labelled for use on rice, EECs were
not calculated for this use since GENEEC was not intended to model rice
uses. The use rate for rice is 1.0 Ibs ai/A, which is less than for cotton.
Thus, the EECs calculated for cotton would probably be greater than the
maximum exposure expected from rice. Pendimethalin is applied directly
to the soil of the rice fields; there is no application to water. Labeling
specifically states that no floodwater should be on the field at time of
application. Once it has been applied, the labeling recommends either
rainfall or irrigation to occur within 7 days for pendimethalin to be most
effective. The field is then flooded within 5-7 days after seeding and is
flushed approximately 90 days later. Virtually all of the water is contained
within the rice field, except that which is lost during storm/rainfall events.
What is lost during these events constitutes mainly water, with little or no
sediment. Based on the environmental fate characteristics, pendimethalin is
expected to be sorbed to the sediment and soil particles, and would not be
found in the water column. If any soil is lost during these events, the
pendimethalin in the water column would tend to sorb to the sediment and
soil with which it comes into contact. Therefore, there are reasons to
conclude the EECs from rice would be less than those calculated for cotton.
Other use sites: Aquatic EECs were not estimated for turf, ornamental,
landscape & grounds maintenance, non-cropland, and nonbearing nuts and
vines (use rates of 3 and 4 Ibs ai/A, ground application only). GENEEC is
a model designed specifically to model runoff from certain agricultural
fields and the risk assessment team did not consider it appropriate for sites
such as these. It is assumed, for assessment purposes, that exposure from
these use patterns would not be higher than exposure from other uses where
GENEEC was used to estimate exposure. This is because these use sites
are typically composed of uniformly treated areas much smaller than the 10
hectare watershed used for GENEEC. On turf, where treated sites could be
larger than 10 hectares, soil erosion is expected to be minimal. When
pendimethalin moves in runoff, it is primarily with suspended soil particles;
therefore, surface water exposure from turf is predicted to be less than from
agricultural fields. Aquatic risk from turf, ornamental, landscape &
grounds maintenance, non-cropland, and nonbearing nuts and vines (use
rates of 3 and 4 Ibs ai/A, ground application only) is not expected to be
greater than from agricultural use sites with similar application rates.
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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 pendimethalin active ingredients. The
Agency has completed its review of these generic data, and has determined that the data
are sufficient to support reregistration of all products containing pendimethalin.
Appendix B identifies the generic data requirements that the Agency reviewed as part of
its determination of reregistration eligibility of pendimethalin, 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 pendimethalin and to determine that pendimethalin can be used without
resulting in unreasonable adverse effects to humans and the environment. The Agency
therefore finds that all products containing pendimethalin as the active ingredients are
eligible for reregistration as specified in this document. 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, published scientific literature, etc. and the data identified in Appendix
B. Although the Agency has found that all uses of pendimethalin 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 pendimethalin, if new information comes to the Agency's attention or
if the data requirements for registration (or the guidelines for generating such data)
change.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients pendimethalin, the
Agency has sufficient information on the health effects of pendimethalin and on its
potential for causing adverse effects in fish and wildlife and the environment. The
Agency/ has determined that pendimethalin products, labeled and used as specified in this
Reregistration Eligibility Decision, will not pose unreasonable risks or adverse effects to
humans or the environment. Therefore, the Agency concludes that products containing
pendimethalin for all uses are eligible for reregistration.
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2. Eligible and Ineligible Uses
The Agency has determined that all uses of pendimethalin are eligible for
reregistration.
C.
Regulatory Position
The following is a summary of the regulatory positions and rationales for
pendimethalin. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1. Food Quality Protection Act Findings
a. Determination of Safety for U.S. Population
EPA has determined that the established tolerances with amendments and
changes as specified in this document for pendimethalin meet the safety
standards under the FQPA amendments to section 408(b)(2)(D) for the general
population. In reaching this determination, EPA has considered the available
information on the aggregate exposures (both acute and chronic) from non-
occupational sources, food, and drinking water.
Pendimethalin has both food and non-occupational uses; therefore, the
considerations for aggregate exposure are those from foods, drinking water,
and residential non-occupational sources.
Chronic dietary risks utilizing tolerance level residues and 100% crop
treated (TMRC) are <1% of the RfD for the general population.
Based on limited ground water monitoring data (data from 8 states with 2
states with detectable residues, the maximum level found was 0.9 ppb. The
maximum level of pendimethalin found in surface water is 17.6 ppb. Based on
this information, the estimated risks from water are <2% of the RfD for all
population subgroups, including those most highly exposed to pendimethalin
residues.
No acute endpoints of concern have been identified for pendimethalin.
In evaluating the potential for cumulative effects, EPA does not have, at
this time, available data to determine whether pendimethalin has a common
mechanism of toxicity with other substances or how to include this pesticide in
a cumulative risk assessment. Unlike other pesticides for which EPA has
followed a cumulative risk approach based on common mechanism of toxicity,
pendimethalin does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA has not
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assumed that pendimethalin has a common mechanism of toxicity with other
substances.
b. Determination of Safety for Infants and Children
EPA has determined that the established tolerances for pendimethalin, with
amendments and changes as specified in this document, meet the safety
standards under the FQPA amendments to section 408(b)(2)(C) for infants and
children. The safety determination for infants and children considers the
factors noted above for the general population, but also takes into account the
possibility of increased dietary exposure due to the specific consumption
patterns of infants and children, as well as the possibility of increased
susceptibility to the toxic effects of pendimethalin residues in this population .
subgroup.
In determining whether or not infants and children are particularly
susceptible to toxic effects from pendimethalin residues, EPA considered the
completeness of the database for developmental and reproductive effects, the
nature and severity of the effects observed, and other information.
Based on current data requirements, pendimethalin has a complete data
base for developmental and reproductive toxicity. The data base for
pendimethalin does not indicate a potential for increased toxicological
sensitivity from pre- and post-natal exposures. No developmental toxicity was
observed in either the rat or rabbit developmental toxicity studies, nor was there
any evidence in the two generation study that there was developmental or
reproductive toxicity at dose levels below those in which parental toxicity was
observed. Therefore, the Agency has determined that an additional uncertainty
factor is not warranted.
The Agency estimates that pendimethalin residues in the diet of non-
nursing infants (less than one year) account for <2% of the RfD.
Although the risk assessment for children exposed to pendimethalin-
treatedx lawns showed an acceptable MOE (111), the Agency has low
confidence in the data used for these exposure calculations and these estimates
do not include ingested or inhaled quantities. Therefore, the Agency has
concerns for post-application exposure to children in residential settings, and is
requiring that the maximum application rate for residential (and sod farms) uses
be reduced from 3.0 Ibs. ai/acre to 2.0 Ibs. ai/acre. (The registrant has agreed to
this mitigation measure.)
In summary, an additional uncertainty factor is not required to protect for
potential adverse developmental or reproductive effects. It is known that
pendimethalin affects the pituitary-thyroid axis; the basis for the RfD (0.10
mg/kg/day) is based on combined subchronic studies (14 days and 28 days) in
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which thyroid changes were observed. Based on thyroid effects, pendimethalin
by definition is an endocrine disrupter. Data cannot rule out the possibility that
children may have special sensitivity to pendimethalin via effects on the
thyroid. However, the data currently available indicate that humans are no
more sensitive than the rodent model to thyroid perturbations.
In deciding to continue to make reregi strati on determinations during the
early stages of FQPA implementations, EPA recognizes that it will be
necessary to make decisions relating to FQPA before the implementation
process is complete. In making these early, case-by-case decisions, EPA does
not intend to set broad precedents for the application of FQPA to its regulatory
determinations. Rather, these early decisions will be made on a case-by-case
basis and will not bind EPA as it proceeds with further policy development and
rulemaking that may be required.
If EPA determines, as a result of this later implementation process, that any
of the determinations described in this RED are no longer appropriate, the
Agency will consider itself free to pursue whatever action may be appropriate,
including but not limited to, reconsideration of any portion of this RED.
c. Effects to the Endocrine System
EPA is required to develop a screening program to determine whether
certain substances (including all active ingredient pesticides and inerts) "may
have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or such other endocrine effect..." The Agency is currently
working with interested stakeholders, including other government agencies,
public interest groups, industry and research scientists in developing a
screening and testing program and a priority setting scheme to implement this
program. Congress has allowed3 years from the passage of FQPA (August 3,
1999) to implement this program. At that time, EPA may require further
testing of this active ingredient and end-use products.
2. Tolerance Reassessment
Tolerances for pendimethalin residues are currently expressed in terms of the
combined residues of pendimethalin and its metabolite 4-[(l-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenzyl alcohol [ง180.361(a and c)] and, for peanut hulls only, in
terms of the parent and aforementioned metabolite plus the metabolite 3-[(l-
ethylpropyl)amino]-6-methyl-2,4-dinitrobenzyl alcohol [40 CFR ง180.361(b)].
A summary of the pendimethalin tolerance reassessment and recommended
modifications in commodity definitions are presented in Table 30.
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Tolerances Listed Under 40 CFR S180.361(a)
Adequate data are available to reassess the established tolerances for pendimethalin
residues in/on beans; bean forage; bean fodder; corn fodder; corn forage; corn grain;
sweet corn; cottonseed; onions (dry bulb); peanuts; peanut hay; potatoes; sorghum
fodder; sorghum forage; grain sorghum; soybeans; soybean forage; soybean hay;
sugarcane; and sunflower seeds. .[Note: Some commodity definitions must be
corrected. See Table 39 for details.]
The tolerance for pendimethalin residues in/on peanut forage should be revoked since
peanut forage is no longer considered to be a significant feed item according to the
Livestock Feeds Table (Table II (September 1995)).
Available rice field trial data are deemed adequate to support the reregi strati on of
pendimethalin for use on rice. The currently established tolerance on rice grain should
be increased from 0.05 ppm to 0.1 ppm. A processing study on rice grain is
outstanding.
Tolerances Needed Under 40 CFR $180.361 (a)
Available rice field trial data are deemed adequate to support the reregi strati on of
pendimethalin for use on rice. A tolerance for pendimethalin residues of concern in/on
rice straw must be established. Available data indicate that a tolerance of 0.1 ppm
would be appropriate.
As a result of changes in the Livestock Feeds Table (Table II (September 1995)), the
Agency currently considers cotton gin byproducts a raw agricultural commodity
(RAC). Data depicting pendimethalin residues of concern in/on cotton gin byproducts
resulting from the maximum registered use of pendimethalin to cotton are hereby
required. On receipt of the required cotton gin byproducts data, the need for
tolerances for pendimethalin residues of concern will be determined.
Tolerances Listed Under 40 CFR S180.36KV)
The tolerance for residues in/on peanut hulls should be revoked since peanut hulls is
no longer considered a significant feed item according to the Livestock Feeds Table
(Table II (September 1995)).
Tolerances Listed Under 40 CFR S180.361(c)
The Agency concludes that available garlic magnitude of the residue data from field
trials conducted in CA and OR are adequate to support a national registration for the
use of pendimethalin on garlic and recommends that the currently established
tolerance with regional registrations for pendimethalin residue of concern in/on garlic
should be changed to a tolerance without regional registrations at the same level (0.1
ppm) and listed under 40 CFR ง180.361(a).
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Table 39. Tolerance Reassessment Summary for Pendimethalin.
Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/Correct Commodity
Definition
Tolerances listed under 40 CFR ง180.361(a):
Beans, lima (dry, snap)
Beans, forage
Beans, hay
Com, fodder
Corn, forage
Com, grain
Corn, fresh (including sweet,
K+CWHR)
Cottonseed
Onions, dry bulb
Peanuts
Peanut, hay
Peanut, forage
Potatoes
Rice, grain
Sorghum, fodder
Sorghum, forage
Sorghum, grain
Soybeans
Soybeans, forage
Soybeans, hay
Sugarcane
Sunflower, seeds
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.05
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
Revoke
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
Beans, succulent and dry
Corn, stover
Corn, field and Corn, pop
Corn, sweet (K+CWHR)
Cotton, undelinted seed
No longer listed as a significant
feed item
The tolerance level' must be
increased to the analytical
method's limit of quantitation
(LOQ) for the combined
residues of pendimethalin and
its 3,5-dinitrobenzyl alcohol
metabolite
Sorghum, stover
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Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/Correc/ Commodity II
Definition 1]
Tolerances needed under 40 CFR ง180.36 l(a): ||
Cotton, gin byproducts
Rice, straw
None
None
TBD"
0.1
Residue data are required.
Tolerances listed under 40 CFR ง180.36 l(b):
Peanut, hulls
0.25
Revoke
No longer listed as a significant
feed item
Tolerances listed under 40 CFR ง180.361(c):
Garlic
0.1
0.1
Agency hereby recommends
that this tolerance should be
listed under 40 CFR
ง180.361 (a)
TBD = To be determined. Reassessment of tolerance(s) cannot be made at this time because residue data are
required.
3.
Codex Harmonization
There are no established or proposed Codex MRLs for pendimethalin residues.
Therefore, there are no questions of compatibility with respect to Codex MRLs and
U.S. tolerances.
4. Summary of Risk Management Decisions
a. Human Health
(1) Acute Dietary
The Agency has concluded that there are no toxicologic endpoints for
acute (one day) dietary exposure to pendimethalin.
(2) Chronic Dietary
The DRES dietary risk assessment for published and reassessed
tolerances of pendimethalin indicate that the overall U.S. population and
the estimated most highly exposed subgroup non-nursing infants receive
less than 4 percent of the pendimethalin Reference Dose (with food and
water sources combined). Since this is a relatively low estimate and is
based on worst-case assumptions, the Agency concludes that chronic
dietary risk to pendimethalin is not a concern for reregistration.
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(3) Short and Intermediate Term Occupational and Residential
The Agency has determined that there is potential exposure to persons
handling pendimethalin. Exposure may occur to: occupational handlers
involved in food, feed, fiber, ornamental, turf, rights-of-way and other
noncrop treatments; and homeowner handlers making applications to
residential turf.
Occupational/Short and Intermediate Term:
Agency calculations indicate that MOEs for handlers wearing baseline
attire (long-sleeve short, long pants, shoes and socks) are over 100 for all
but three scenarios. For three scenarios (mixing/loading liquid for aerial
applications and irrigation systems, mixing/loading liquid for rights-of-way
spraying, and mixing/loading liquid for groundboom applications), the
MOEs range from 1.5 to 59. The risks to these handlers in these three
scenarios are reduced to an adequate level (MOEs range from 110 to
33,333) when chemical-resistant gloves are added to the baseline attire.
Occupational/Post Application:
The Agency has determined that there are risks following applications
to commercial or research food, feed, fiber, turf, and ornamental crops.
REIs allow sufficient time to pass for residues to dissipate to levels that
result in adequate MOEs. Pending the development of pendimethalin-
specific post application exposure data (foliar and soil residue dissipation
studies-guidelines 132(a) and 132(b)), the Agency is requiring that the 12-
hour interim REI be increased to 24 hours for all pendimethalin uses within
the WPS.
However, REIs are generally not feasible as a mitigation measure for
occupational exposures in noncrop areas (such as rights-of-way). As
represented in Tables 7, 8, and 9 (post application risk estimates for
residential turf, golf course turf and sod farm turf) the MOE's are
unacceptable at the 3 Ib. ai/acre rate. Therefore, as a risk mitigation
measure, the Agency is requiring a reduction in the maximum use rate from
3 Ibs ai/acre to 2 Ibs. ai/acre. The registrant has agreed to reduce the
maximum application rate from 3.0 Ibs. ai/acre to 2 Ibs.ai/acre on
residential and recreation area turf grass.
Residential/Post Application:
Again, REIs are not practical or feasible for residential or recreational
turf, consequently, the Agency is requiring a reduction in the maximum use
rate to 2 Ibs. ai/acre.
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b. Environmental
(1) Avian
Acute/Chronic
Pendimethalin does not represent a high acute risk to birds. The .chronic
risk to birds could not be determined because avian reproduction studies
have not been submitted
(2) Mammals
Pendimethalin does not represent a high acute or chronic risk to
mammals.
(3) Fish
Chronic risk LOCs for fish were exceeded by a small margin. But it is
presumed that overall, pendimethalin does not represent a high risk to
aquatic animals and plants, including estuarine organisms. .
(4) Nontarget Plants (Terrestrial and Semi-Aquatic)
The risk to nontarget terrestrial and semi-aquatic plants is expected to be
moderate.
(5) Endangered Species
The use of pendimethalin may adversely affect endangered species of
terrestrial and semi-aquatic plants, aquatic plants and invertebrates
including mollusks, fish and birds (specifically grazers).
Currently, the Agency is developing a program ("The Endangered
Species 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 restrictions to protect endangered and threatened species at the
county level. Consultations with the Fish and Wildlife Service may be
necessary to assess risks to newly listed species from proposed new uses.
In the future, the Agency plans to publish a description of the Endangered
Species Program in the Federal Register and have available voluntary
county-specific bulletins. 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..
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5. Labeling Rationale
Occupational/Residential
The 1992 Worker Protection Standard for Agricultural Pesticides (WPS)
established certain worker-protection requirements (personal protective equipment,
restricted-entry intervals, etc.) to be specified on the label of all products that contain
uses within the scope of the WPS. Uses within the scope of the WPS include all
commercial (non-homeowner) and research uses on farms, forests, nurseries, and
greenhouses to produce agricultural plants (including food, feed, and fiber plants,
trees, turf grass, flowers, shrubs, ornamentals, and seedlings). Uses within scope
include not only uses on plants, but also uses on the soil or planting medium in which
the plants are (or will be) grown.
At this time some 'of the registered uses of pendimethalin are within the scope
of the Worker Protection Standard for Agricultural Pesticides (WPS). Uses that are
outside the scope of the WPS include use:
on plants that are in ornamental gardens, parks, golf courses, and public or
private lawns and grounds and that are intended only for decorative or
environmental benefit. (However, pesticides used on sod farms ARE covered
by the WPS).
in a manner not directly related to the production of agricultural plants,
. including, for example, control of vegetation along rights-of-way and in other .
noncrop areas.
Compliance with the WPS
Any product whose labeling can be reasonably interpreted to permit use in the
production of an agricultural plant on any farm, forest, nursery, or greenhouse must
comply with the labeling requirements of PR Notice 93-7, "Labeling Revisions
Required by the Worker Protection Standard (WPS)," and PR Notice 93-11,
"Supplemental Guidance for PR Notice 93-7," which reflect the requirements of EPA's
labeling regulations for worker protection statements (40 CFR part 156, subpart K).
These labeling revisions are necessary to implement the Worker Protection Standard
for Agricultural Pesticides (40 CFR part 170) and must be completed in accordance
with, and within the deadlines specified in, PR Notices 93-7 and 93-11. Unless
otherwise specifically directed in this RED, all statements required by PR Notices 93-7
and 93-11 are to be on the product label exactly as instructed in those notices.
After April 21, 1994, except as otherwise provided in PR Notices 93-7 and
93-11, the labeling of all products within the scope of those notices must have
met the requirements of the notices when the products are distributed or sold by
the primary registrant or any supplementally registered distributor.
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After October 23, 1995, except as otherwise provided in PR Notices 93-7 and
93-11, the labeling of all products within the scope of those notices must meet
the requirements of the notices when the products are distributed or sold by any
person.
Personal Protective Equipment/Engineering Controls for Handlers
For each end-use product, PPE requirements for pesticide handlers are set
during reregi strati on in one of two ways:
1. If EPA determines that no regulatory action must be taken as the result of the
acute effects or other adverse effects of an active ingredient, the PPE for
pesticide handlers will be based on the acute toxicity of the end-use product.
For occupational-use products, PPE must be established using the process
described in PR Notice 93-7 or more recent EPA guidelines.
2. If EPA determines that regulatory action on an active ingredient must be taken
as the result of very high acute toxicity or to certain other adverse effects, such
as allergic effects or delayed effects (cancer, developmental toxicity,
reproductive effects, etc.):
In the RED for that active ingredient, EPA may establish minimum or
"baseline" handler PPE requirements that pertain to all or most 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 the end-use
product.
The more stringent choice for each type of PPE (i.e., body wear, hand
protection, footwear, eyewear, etc.) must be placed on the label of the end-
use product.
Personal protective equipment requirements usually are set by specifying one
or more preestablished PPE units ~ sets of items that are almost always required
together. For example, if chemical-resistant gloves are required, then long-sleeve
shirts, long pants, socks, and shoes are assumed and are also included in the required
minimum attire. If the requirement is for two layers of body protection (coveralls over
a long- or short-sleeve shirt and long or short pants), the minimum must also include
(for all handlers) chemical-resistant footwear and chemical-resistant headgear for
overhead exposures and (for mixers, loaders, and persons cleaning equipment)
chemical-resistant aprons.
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Occupational-Use Products
The Agency has determined that regulatory action regarding the establishment
of active-ingredient-based minimum PPE requirements for occupational handlers must
be taken for pendimethalin for certain handler use-situations. The MOEs were less
than 100 for certain occupational handler (mixers, loaders, and applicators) use-
scenarios, unless chemical-resistant gloves were used in addition to the baseline
protection of long-sleeve shirt, long pants, shoes, and socks. The Agency is requiring
active-ingredient-based protections for handlers of pendimethalin in these exposure
situations: (1) mixing and loading emulsifiable concentrate formulations and (2)
mixing, loading, and applying using low-pressure handwand equipment. In addition,
since wettable powder formulations are currently contained in water-soluble packaging
and the Agency's exposure and risk assessments were based on that assumption, the
Agency will require wettable powder formulations of pendimethalin to be contained in
water-soluble packaging. If the Registrant intends to register any wettable powder
product not contained in water-soluble packaging, the Agency must first conduct an
exposure risk assessment to determine if mitigation measures such as PPE would be
necessary.
WPS and NonWPS Uses: Since potential handler exposure is similar for
WPS and'nonWPS uses, there is only one set of active-ingredient-based minimum
(baseline) PPE requirements for occupational uses of pendimethalin (specified in
Section V). These requirements must be followed in the labeling of all pendimethalin
end-use products intended primarily for occupational use.
Homeowner-Use Products
The Agency is not establishing minimum (baseline) handler PPE for
pendimethalin end-use products that are intended primarily for homeowner use,
because the Agency has determined that the frequency, duration, and degree of
exposure by such handlers do not warrant such risk mitigation measures.
Postapplication/Entry Restrictions
Occupational-Use Products (WPS
Restricted-Entry Interval:
Under the Worker Protection Standard (WPS), interim restricted-entry
intervals (REIs) for all uses within the scope of the WPS are based on the acute
toxicity of the active ingredient. The toxicity categories of the active ingredient
for acute dermal toxicity, eye irritation potential, and skin irritation potential
are used to determine the interim WPS REI. If one or more of the three acute
toxicity effects are in toxicity category I, the interim WPS REI is established at
48 hours. If none of the acute toxicity effects are in category I, but one or more
of the three is classified as category II, the interim WPS REI is established at
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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. In addition, the WPS specifically
retains two types of REI's established by the Agency prior to the promulgation
of the WPS: (1) product-specific REIs established on the basis of adequate
data, and (2) interim REIs that are longer than those that would be established
under the WPS.
During the reregistration process, EPA considers all relevant product-
specific information to decide whether there is reason to shorten or lengthen the
previously established REI.
By default, PR Notice 93-7 specifies a 12 hour interim REI currently in
effect. EPA notes that the 12-hour interim WPS REI was established because
data indicated that pendimethalin was in toxicity category III/IV for acute
dermal toxicity, skin irritation potential, and eye irritation potential.
During the reregistration process, the Agency has determined that the REI
established under the WPS should be changed for some uses due to:
-the identification of short and intermediate term toxicity endpoints of concern,
-the potential for significant postapplication worker exposure in certain crops,
-a number of reported incidents for pendimethalin,
-an absence of acceptable pendimethalin-specific post application exposure
data for all use sites and scenarios, and
-the findings of the Agency's analysis of potential post-application exposure
risk using surrogate data and reasonable worst-case assumptions.
Thus, the Agency is establishing a 24-hour restricted-entry of all
occupational-use products that contain pendimethalin and have use-
directions for commercial or research food, feed, fiber,, ornamental,
forestry, and turfgrass crops grown for commercial or research purposes.
Early-Entry PPE:
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. Under the WPS, these personal protective equipment requirements for
persons who must enter areas that remain under a restricted-entry interval are
based on the acute toxicity category of the active ingredient.
During the reregistration process, EPA considers all relevant product-
specific information to decide whether there is reason to set personal protective
equipment requirements that differ from those set through the WPS.
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The RED requirements for early-entry PPE are set in one of two ways:
1. If EPA determines that no regulatory action must be taken as the result
of the acute effects or other adverse effects of an active ingredient, it
establishes the early-entry PPE requirements on the basis of the acute
dermal toxicity category, skin irritation potential category, and eye
irritation potential category of the active ingredient.
2. If EPA determines that regulatory action on an active ingredient must be
taken as the result of very high acute toxicity or to certain other adverse
effects, such as allergic effects or delayed effects (cancer,
developmental toxicity, reproductive effects), it may establish early-
entry PPE requirements that are more stringent than would be
established otherwise.
The PPE for dermal protection required for early entry based on the
acute toxicity categories, non-acute toxicity endpoints, and the potential
for post-application dermal exposure are coveralls, chemical-resistant
gloves, and shoes plus socks.
WPS Notification Statement:
Under the WPS, the labels of some pesticide products must require
employers to notify workers about pesticide-treated areas orally as well as
by posting of the treated areas. The reregistration process also may decide
that a product requires this type of "double notification."
. The Agency has determined that double notification is not required for
pendimethalin end-use products.
Occupational-Use Products (NonWPS Uses)
Since the Agency has concerns about post-application exposures to
persons after nonWPS occupational uses of pendimethalin, it is establishing
entry restrictions for all nonWPS occupational uses of pendimethalin end-
use products. For specific requirements, refer to Section V of this
document.
Homeowner-Use Products
Since the Agency has concerns about post-application exposures to
persons after homeowner applications of pendimethalin, the Agency is
establishing entry restrictions for all homeowner uses of pendimethalin
end-use products. For specific requirements, refer to Section V of this
document.
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(Note: The registrant has agreed to a reduction in the maximum
application rate from 3 Ibs. active ingredient per acre to 2 Ibs. active
ingredient per acre on residential and recreation area turf grass.)
Other Labeling Requirements
The Agency is also requiring other use and safety information to be
placed on the labeling of all end-use products containing pendimethalin.
For the specific labeling statements, refer to Section V of this document.
6. Spray Drift Advisory
The Agency has been working with the Spray Drift Task Force, EPA Regional
Offices and State Lead Agencies for pesticide regulation to develop the best spray drift
management practices. The Agency is now requiring interim measures that must be
placed on product labels/labeling as specified in Section V. Once the Agency
completes its evaluation of the new data base submitted by the Spray Drift Task Force,
a membership of U.S. pesticide registrants, the Agency may impose further
refinements in spray drift management practices to further reduce off-target drift and
risks associated with this drift.
7. Environmental Hazards Statement
All pesticides with outdoor, terrestrial uses are required to have an
environmental hazard statement. Specific language is found in section V of
this document.
V. ACTIONS REQUIRED OF 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 pendimethalin for the
above eligible uses has been reviewed and determined to be substantially complete.
Additional confirmatory data are needed to fulfill requirements for the studies listed
below:
Required Handler Studies:
No chemical-specific handler exposure data for pendimethalin exists and
the Agency has low confidence in the data available for several pendimethalin
use scenarios. Additional handler exposure studies are required. Requirements
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for such studies are addressed in Subdivision U of the Pesticide Assessment
Guidelines. The required studies are for dermal exposure (Guideline 231) and
are necessary to provide data on mixers, loaders, and applicators for:
o high volume turf sprayer applications with WP/WDG/liquid
formulations;
o low pressure handwand applications with WDG/liquid formulations;
o backpack sprayer applications with WDG/liquid formulations; and
o rights-of-way applications with WDG/liquid formulations.
EPA notes that the registrant is a member of the Outdoor Residential
Exposure Task Force (ORETF) and that some of the required data for
applications to turf is being developed by the task force. Guideline 231 studies
may be reserved at this time pending the completion of the ORETF studies.
Required Postapplication Studies
There are no pendimethalin-specific post-application exposure data
available at this time. These chemical-specific data are necessary for EPA to
establish permanent restricted-entry intervals since a short and intermediate-
term endpoint of concern has been identified. The registrant must submit
postapplication exposure studies. Requirements for such postapplication
exposure studies are addressed by subdivision K of the Pesticide Assessment
Guidelines. Data are required to support the use of pendimethalin on the
following crop groups/use sites:
o food, feed, and fiber crops (transplanting and weeding tobacco);
o ornamental crops (harvesting/transplanting woody ornamentals);
o residential turfgrass; and
o sod farm turfgrass (harvesting).
Requirements for post-application/reentry exposure studies are addressed by
Subdivision K of the Pesticide Assessment Guidelines. The required data
include:
o foliar residue dissipation (Guideline 132-1 (a);
o soil residue dissipation (Guideline 132-l(b); and
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2.
o postapplicatipn dermal passive dosimetry exposure (Guideline 133-3) may
be reserved at this time pending completion of the databases on agricultural and
residential post-application/reentry exposure currently being developed by the
Agricultural Reentry Task Force and the ORETF since the Registrant is a
member of both task forces.
Product chemistry
Additional physical/chemical properties for the 86.8% and 60% FIs.
Residue Chemistry
Magnitude of residue studies for tobacco and cotton gin byproducts - Guideline
171-4(k) '
Rice processing study - Guideline 171-4(1)
Ecological Effects
Avian Chronic - Guideline 71-4
Environmental Fate
Field Dissipation - Guideline 164-1 - cotton and soybeans
Aquatic Dissipation - Guideline 164-2 - rice
Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations, PR Notices and
applicable policies. The MP labeling must bear the following statement under
Directions for Use:
"Only for formulation into a herbicide for the following use(s):..."
An MP registrant may, at his/her discretion, add one of the following statements to an
MP label under
"Directions for Use" to permit the reformulation of the product for a
specific use or all additional uses supported by a formulator or user
group:
(a) "This product may be used to formulate products for specific use(s) not
listed on the MP label if the formulator, user group, or grower has
108
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complied with U.S. EPA submission requirements regarding support of
such use(s)."
(b) "This product may be used to formulate products for any additional
use(s) not listed on the MP label if the fdrmulator, user group, or grower
has complied with U.S. EPA submission requirements regarding support
of such use(s)."
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. Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria and if not, commit to conduct new studies. If a
registrant believes that previously submitted data meet current testing standards, then
study MRID numbers should be cited according to the instructions in the Requirement
Status and Registrants Response Form provided for each product.
2. Labeling Requirements for End-Use Products
a. Occupational/Residential
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredientend-use products that contain pendimethalin, the
product labeling must be revised to adopt the handler personal protective
equipment/engineering control requirements set forth in this section. Any
conflicting PPE requirements on the current labeling must be removed.
For multiple-active-ingredientend-use products that contain pendimethalin,
the handler personal protective equipment/engineering control requirements set
forth in this section must be compared to the requirements on the current
labeling and the more protective must be retained. For guidance on which
requirements are considered more protective, see PR Notice 93-7.
Products Intended Primarily for Occupational Use (WPS and nonWPS)
Minimum (Baseline) PPE/Engineering Control Requirements
The Agency is establishing minimum (baseline) engineering controls for
occupational uses of pendimethalin end-use products formulated as wettable
powders. All wettable powder formulations must be contained in water-soluble
packaging.
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The Agency is establishing minimum (baseline) personal protective equipment
(PPE) requirements for some occupational uses of pendimethalin end-use
products. The minimum (baseline) PPE for occupational uses of pendimethalin
end-use products are:
For emulsifiable concentrate formulations:
"Mixers and loaders must wear:
long-sleeved shirt and long pants,
chemical-resistant gloves*, and
shoes plus socks."
* For the glove statement, use the statement established for pendimethalin
through the instructions in Supplement Three of PR Notice 93-7.
For water-dispersible granule, wettable powder, and emulsifiable concentrate
formulations whose use directions reasonably permit application using hand-
held sprayers:
"Commercial Handlers (mixers, loaders, and applicators) who apply this
product using hand-held equipment or hoses (not including hoses attached to
truck-mounted equipment) must wear:
~ long-sleeved shirt and long pants,
~ chemical-resistant gloves*, and
~ shoes plus socks."
* For the glove statement, use the statement established for pendimethalin
through the instructions in Supplement Three of PR Notice 93-7.
Determining PPE Requirements for End-use Product Labels
The PPE that would be established on the basis of the acute toxicity category of
the end-use product must be compared to the active-ingredient-based minimum
(baseline) personal protective equipment specified above. The more protective
PPE must be placed on the product labeling. For guidance on which PPE is
considered more protective, see PR Notice 93-7.
Placement in Labeling
The personal protective equipment requirements must be placed on the end-use
product labeling in the location specified in PR Notice 93-7, and the format and
language of the PPE requirements must be the same as is specified in PR
Notice 93-7.
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Products Intended Primarily for Homeowner Use
Minimum (baseline) PPE Requirements
The Agency is not establishing active-ingredient-based minimum (baseline)
handler PPE for pendimethalin end-use products that are intended primarily for
homeowner use.
Determining PPE Requirements for End-Use Product Labels
Any necessary PPE for each pendimethalin end-use product intended primarily
for homeowner use will be established on the basis of the end-use product's
acute toxicity category.
Placement in Labeling
The personal protective equipment requirements, if any, must be placed on the
end-use product labeling immediately following the precautionary statements in
the labeling section "Hazards to Humans (and domestic animals)."
Entry Restrictions
For sole-active-ingredientend-use products that contain pendimethalin the
product labeling must be revised to adopt the entry restrictions set forth in this
section. Any conflicting.entry restrictions on the current labeling must be
removed.
For multiple-active-ingredientend-use products that contain pendimethalin
the entry restrictions set forth in this section must be compared to the entry
restrictions on the current labeling and the more protective must be retained. A
specific time period in hours or days is considered more protective than "sprays
have dried" or "dusts have settled."
Products Intended Primarily for Occupational Use
WPS Uses
Restricted-entry interval:
A 24-hour restricted-entry interval (REI) is required for uses on food, feed,
fiber, ornamental, forestry, and turf crops within the scope of the WPS on all
pendimethalin end-use products.
"Exception: if the product is soil-injected or soil-incorporated, the Worker
Protection Standard, under certain circumstances, allows workers to enter the
treated area if there will be no contact with anything that has been treated."
Ill
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Early-entry personal protective equipment (PPE):
The PPE required for early entry is:
coveralls,
chemical-resistant gloves, and
shoes plus socks,
Placement in labeling:
The REI and PPE required for early entry must be inserted into the
standardized REI statement required by Supplement Three of PR Notice 93-7.
NonWPS uses
Entry restrictions:
The Agency is establishing the following entry restrictions for nonWPS
occupational uses of pendimethalin end-use products: (NOTE: This presumes
the registrant reduces the maximum application rate for turf at residential sites
and parks and recreation areas to two pounds active ingredient per acre.)
For liquid applications:
"Do not enter or allow others to enter the treated area until sprays have dried."
For dry applications:
"Do not enter or allow others to enter the treated area until dusts have settled."
Placement in labeling;
If WPS uses are also on label Follow the instructions in PR Notice 93-7 for
establishing a Non-Agricultural Use Requirements box, and place the
appropriate nonWPS entry restrictions in that box.
If no WPS uses are on the label Place the appropriate nonWPS entry
restrictions in the Directions for Use, under the heading "Entry Restrictions."
Products Intended Primarily for Homeowner Use
Entry restrictions:
The Agency is establishing the following entry restrictions for all homeowner
uses of pendimethalin end-use products (NOTE: This presumes trie registrant
reduces .the maximum application rate for turf at residential sites and parks and
recreation areas to two pounds active ingredient per acre.):
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For liquid applications:
"Do not allow people or pets to touch treated plants until the sprays have
dried." .
For dry applications:
"Do not allow people or pets to enter the treated area until dusts have settled."
Placement in labeling;
Place the appropriate entry restrictions in the Directions for Use, under the
heading "Entry Restrictions."
Other Labeling Requirements
Products Intended Primarily for Occupational Use
The Agency is requiring the following labeling statements to be located on all end-use
products containing pendimethalin that are intended primarily for occupational use.
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
1. {Registrant: add the following statements if coveralls are required for pesticide
handlers on the end-use product label:}
Discard clothing or other absorbent materials that have been drenched or heavily
contaminated with this product's concentrate. Do not reuse them.
2. (Registrant: add the following statement always:}
Follow manufacturer's instructions for cleaning/maintaining PPE. If no such
instructions for washables, use detergent and hot water. Keep and wash PPE
separately from other laundry.
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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."
ป "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."
Products Intended Primarily for Home Use
Application Restrictions
"Do not apply this product in a way that will contact any person or pet, either
directly or through drift. Keep people and pets out of the area during application."
User Safety Recommendations
"Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
ป "Users should remove clothing immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing."
b. Environmental Hazards Statement
"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 washwaters."
c. Application Rates
The labels of all pendimethalin end-use products must be revised to bear the
following application rate for the respective uses:
For residential lawn and sod farm uses:
"Maximum application rate of 2.0 Ibs. active ingredient per acre."
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C. Spray Drift Labeling
The following language must be placed on each product label that can be applied
aerially:
Avoiding spray drift at the application site is the responsibility of the
applicator. The interaction of many equipment-and-weather-related factors
determine the potential for spray drift. The applicator and the grower are
responsible for considering all these factors when making decisions.
The following drift management requirements must be followed to avoid off-
target drift movement from aerial applications to agricultural field crops. These
requirements do not apply to forestry applications, public health uses or to
applications using dry formulations.
1. . The distance of the outer most nozzles on the boom must not exceed 3/4 the
length of the wingspan or rotor.
2. Nozzles must always point backward parallel with the air stream and never
be pointed downwards more than 45 degrees.
Where states have more stringent regulations, they should be observed.
The applicator should be familiar with and take into account the information
covered in the Aerial Drift Reduction Advisory Information.
The following aerial drift reduction advisory information must be contained in
the product labeling:
[This section is advisory in nature and does not supersede the mandatory label
requirements.]
INFORMATION ON DROPLET SIZE
The most effective way to reduce drift potential is to apply large droplets. The
best drift management strategy is to apply the largest droplets that provide
sufficient coverage and control. Applying larger droplets reduces drift
potential, but will not prevent drift if applications are made improperly, or
under unfavorable environmental conditions (see Wind, Temperature and
Humidity, and Temperature Inversions).
CONTROLLING DROPLET SIZE
Volume - Use high flow rate nozzles to apply the highest practical spray
volume. Nozzles with higher rated flows produce larger droplets.
115
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Pressure - Do not exceed the nozzle manufacturer's recommended
pressures. For many nozzle types lower pressure produces larger droplets.
When higher flow rates are needed, use higher flow rate nozzles instead of
increasing pressure.
Number of nozzles - Use the minimum number of nozzles that provide
uniform coverage.
Nozzle Orientation - Orienting nozzles so that the spray is released parallel
to the airstream produces larger droplets than other orientations and is the
recommended practice. Significant deflection from horizontal will reduce
droplet size and increase drift potential.
Nozzle Type - Use a nozzle type that is designed for the intended
application. With most nozzle types, narrower spray angles produce larger
droplets. Consider using low-drift nozzles. Solid stream nozzles oriented
straight back produce the largest droplets and the lowest drift.
BOOM LENGTH
For some use patterns, reducing the effective boom length to less than 3/4 of
the wingspan or rotor length may further reduce drift without reducing swath
width.
APPLICATION HEIGHT
Applications should not be made at a height greater than 10 feet above the top
of the largest plants unless a greater height is required for aircraft safety.
Making applications at the lowest height that is safe reduces exposure of
droplets to evaporation and wind.
SWATH ADJUSTMENT
When applications are made with a crosswind, the swath will be displaced
downward. Therefore, on the up and downwind edges of the field, the
applicator must compensate for this displacement by adjusting the path of the
aircraft upwind. Swath adjustment distance should increase, with increasing
drift potential (higher wind, smaller drops, etc.)
WIND
Drift potential is lowest between wind speeds of 2-10 mph. However, many
factors, including droplet size and equipment type determine drift potential at
any given speed. Application should be avoided below 2 mph due to variable
wind direction and high inversion potential. NOTE: Local terrain can
116
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influence wind patterns. Every applicator should be familiar with local wind
patterns and how they affect spray drift.
TEMPERATURE AND HUMIDITY
When making applications in low relative humidity, set up equipment to
produce larger droplets to compensate for evaporation. Droplet evaporation is
most severe when conditions are both hot and dry.
TEMPERATURE INVERSIONS
Applications should not occur during a temperature inversion because drift
potential is high. Temperature inversions restrict vertical air mixing, which
causes small suspended droplets to remain in a concentrated cloud. This cloud
can move in unpredictable directions due to the light variable winds common
during inversions. Temperature inversions are characterized by increasing
temperatures with altitudes and are common on nights with limited cloud cover
and light to no wind. They begin to form as the sun sets and often continue
into the morning. Their presence can be indicated by ground fog; however, if
fog is not present, inversions can also be identified by the movement of smoke
from a ground source or an aircraft smoke generator. Smoke that layers and
moves laterally in a concentrated cloud (under low wind conditions) indicates
an inversion, while smoke that moves upward and rapidly dissipates indicates
good vertical air mixing.
SENSITIVE AREAS
The pesticide should only be applied when the potential for drift to adjacent
sensitive areas (e.g. residential areas, bodies of water, known habitat for
threatened or endangered species, non-target crops) is minimal (e.g. when wind
is blowing away from the sensitive areas).
D. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for
26 months from the date of the issuance of this Reregi strati on 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 pendimethalin
products bearing old labels/labeling for 26 months from the date of issuance of this RED.
Persons other than the registrant may distribute or sell such products for 50 months from
the date of the issuance of this RED. Registrants and persons other than registrants
117
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remain obligated to meet preexisting Agency imposed label changes and existing stocks
requirements applicable to products they sell or distribute.
118
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VI. APPENDICES
119
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APPENDIX A. Table of Use Patterns Subject to Reregistration
Appendix A is 69 pages long and is not being included. Copies of Appendix A are
available upon request per the instructions in Appendix E
121
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the case Pendimethalin covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Pendimethalin in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each .study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
122
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2.
3.
GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregi strati on Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies in
support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included.
UNITS OF ENTRY. The Unit of entry in this bibliography is called a "study". In the case
of published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they
were submitted. The resulting "studies" generally have a distinct title (or at least a single
subject), can stand alone for purposes of review and can be described with a conventional
bibliographic citation. The Agency has also attempted to unite basic documents and
commentaries upon them, treating them as a single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique to
the citation, and should be used whenever a specific reference is required. It is not related
to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen
to show a personal author. When no individual was identified, the Agency has shown
an identifiable laboratory or testing facility as the author. When no author or
laboratory could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the
date is followed by a question mark, the bibliographer has deduced the date from the
evidence contained in the document. When the date appears as (19??), the Agency
was unable to determine or estimate the date of the document.
141
-------
c. Tide. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest 'known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
number, or other administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to
the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the
original submission of the study appears. The six-digit accession, number
follows the symbol "CDL," which stands for "Company Data Library." This
' accession number is in turn followed by an alphabetic suffix which shows the
relative position of the study within the volume.
142
-------
BIBLIOGRAPHY
MRID
CITATION
FAOPEN05 EG&G Bionomics. 1976. Acute toxicity of CL-92,553 to Daphnia magna.
(Unpublihed study received under 241-243; submitted by American Cyanamid Co.
Princeton, N. J
00018997 Smith, J.; Lignowski, E.; Coble, H.D.; et al. (1978) Summary: Prowl (CL 92,553)
plus Cotoran (Fluometuron) Preemergence Tank Mixture-Soil and Cottonseed
Residues. (Unpublished study received Sep 11, 1978 under 241-243; prepared in
cooperation with North Carolina State Univ., Crop Science Dept, Upper Coastal
Plain Research Station, submitted by American Cyanamid Co., Princeton, N.J.;
CDL:235084-B)
00019004 Boughton, P. (1974) CL 92,553: Determination of N-(l-Ethylpropyl)-
3,4-dimethyl-2,6-dinitrobenzenamine in Cottonseed Meal. Method M-524 dated Jun
28, 1974. (Unpublished study received Sep 12, 1978 under 241-243; submitted by
; American Cyanamid Co., Princeton, N.J.; CDL:235084-I)
00023780 Wyckoff, J.C.; Tondreau, R.E. (1974) Prowl (CL 92,553): The Gas
Chromatographic Determination of CL 92,553...and CL 202,347...Residues in Corn
(Foliage), Soybean (Foliage) and Wheat (Foliage) and CL 92,553 in Soil: Report No.
C-454. Summary of studies 094474-C through 094474-E. (Unpublished study
received Sep 27, 1974 under 5F1556; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:094474-B)
00023781 Wyckoff, J.C. (19??) CL 92,553: Determination of N-(l-Ethyl propyl)-
4-dimethyl-2,6-dinitrobenzaminein Corn Plants. Undated method M-458.1.
(Unpublished study received Sep 27, 1974 under 5F1556; submitted by American
Cyanamid Co., Princeton, N.J.; CDL:094474-C)
00023782 Wyckoff, J. (1974) CL 92,553: Determination of N-(l-Ethylpropyl)-3,
4-dimethyl-2,6-dinitrozenzenamine | in Corn Grain. Undated meth-
od M-465.1. (Unpublished study received Sep 27, 1974 under
5F1556; submitted by American Cyanamid Co., Princeton, N.J.;
CDL:094474-E)
00023786 Wyckoff, J.C.; Bodnarchuk, D.; Potts, C.; et al. (1974) Prowl (CL
92,553): Determination of CL 92, 553...and CL 202, 347...Residue
in Field Corn Tissues (Grain and Forage): Report No. C-457.
(Unpublished study received Sep 27, 1974 under 5F1556; submitted
by American Cyanamid Co., Princeton, N.J.; CDL:094474-K)
143
-------
BIBLIOGRAPHY
MRID
CITATION
00023787 WyckofF, J.C.; Bodnarchuk, D.; Moyer, M.; et al. (1974) Prowl (CL
92,553): Determination of CL 92,553...and CL 202, 347...Residues
in Field Corn Tissues: Report No. C-459. (Unpublished study re-
ceived Sep 27, 1974 under 5F1556; submitted by American Cyanamid
Co., Princeton, N.J.; CDL:094474-L)
00023788 Bodnarchuk; Wyckoff, J.C.; Nzewi, G.I. (1974) Prowl (CL 92,553):
Determination of CL 92,553...and CL 202,3 47...Residues in Field
Corn Tissues: Report No. C-450. (Unpublished study received Sep
27, 1974 under 5F1556; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:094474-M)
00023789 Wyckoff, J.C.; Bodnarchuk, D.; Moyer, M., et al. (1974) Prowl (CL
92,553): Determination of CL 92,553..., CL 202, 347..., Atra-
zine...and Bladex...Residues in Corn Tissues: Report No. C-456.
(Unpublished study received Sep 27, 1974 under 5F1556; submitted
by American Cyanamid Co., Princeton, N.J.; CDL:094474-N)
00023790 Wyckoff, J.C.; Bodnarchuk, D.; Nzewi, G.I. (1974) Prowl (CL
92,553): Determination of CL 92,553..., CL 202,347..., Atra-
zine...and Bladex...Residues in Field Corn Tissues: Report
No. C-460. (Unpublished study received Sep 27, 1974 under
5F1556; submitted by American Cyanamid Co., Princeton, N.J.;
CDL:094474-O)
00023791 Moyer, M.; Potts, C.; Bodnarchuk, D.; et al. (1974) Prowl (CL
92,553): Determination of CL 92,553..., CL 202,347..., and Atra-
zine...and Bladex...Residues in Field Corn Tissues: Report
No. C-461. (Unpublished study received Sep 27, 1974 under
5F1556; submitted by American Cyanamid Co., Princeton, N.J.;
CDL:094474-P)
00023792 Moyer, M.; Potts, C.; Wyckoff, J.C.; et al. (1974) Prowl (CL
92,553): Determination of CL 92,553..., CL 202,347..., Atra-
zine...Residues in Field Corn Tissues: Report No. C-463. (Un-
published study received Sep 27, 1974 under 5F1556; submitted
by American Cyanamid Co., Princeton, N.J.; CDL:094474-Q)
144
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BIBLIOGRAPHY
MRID
CITATION
00023793 Moyer, M.; Potts, C.; Wyckoff, J.C.; et al. (1974) Prowl (CL
92,553): Determination of CL 92,553..., CL 202,347..., Atra-
zine...and Bladex...Residues in Field Corn Tissues: Report
No. C-464. (Unpublished study received Sep 27, 1974 under
5F1556; submitted by American Cyanarnid Co., Princeton, N.J.;
CDL:094474-R)
00023794 Wyckoff, J.C.; Moyer, M.; Potts, C.; et al. (1974) Prowl (CL
92,553): Determination of CL 92,553..., CL 202,347..., Atra-
zine...and Bladex...Residues in Field Corn Tissues: Report
No. C-465. (Unpublished study received Sep 27, 1974 under
5F1556; submitted by American Cyanamid Co., Princeton, N.J.;
CDL:094474-S)
00023795 Wyckoff, J.C.; Bodnarchuk, D.; Moyer, M.; etal. (1974) Prowl (CL
92,553): Determination of CL 92,553..., CL 202,347..., Atra-
zine...and Bladex...Residues in Field Corn Tissues: Report
No. C-466. (Unpublished study received Sep 27, 1974 under
5F1556; submitted by American Cyanamid Co., Princeton, N.J.;
CDL:094474-T)
00023796 Tondreau, R.E. (1973) Prowl (CL 92,553): Determination of CL 92,553
0~N~-(l-Ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzanamine | Res-
idues in Milk: Report No. C-384. (Unpublished study received
Sep 27, 1974 under 5F1556; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:094474-U)
00025752 Wolfe, G.W.; Mistrettal, L.H.; Kapp, R.W., Jr. (1979) Oral Teratol-
ogy Study in Rats: AC 92,553: Final Report: Project No. 362-
155. Includes methods M-830 dated Nov 18, 1977 and C-1648 dated
Dec 13, 1979. (Unpublished study including appendix by submit-
ter, received Jan 14, 1980 under 241-243; prepared in coopera-
tion with Hazleton Laboratories America, Inc., submitted by
American Cyanamid Co., Princeton, N.J.; CDL:241595-A)
145
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BIBLIOGRAPHY
MRID
CITATION
00025818 Boughton, P.J.; Moyer, M.; Kust, C.A.; et al. (1976) Residues of
Prowl Herbicide and Its Metabolite in Cotton and Soybeans. (Un-
published study received Feb 13, 1980 under 241-243; prepared in
cooperation with Univ. of North Carolina and others, submitted
by American Cyanamid Co., Princeton, N.J.; CDL:241781-A)
00025820 Wyckoff, J.C. (1974) CL 92,553: Determination of N-(l-Ethylpropyl)-
3,4-dimethyl-2,6-dinitrobenzenamine in Soybean Plants. Method
M-.483.1 dated Jul 23, 1974. (Unpublished study received Feb 13,
1980 under 241-243; submitted by American Cyanamid Co., Prince-
ton, N.J.; CDL:241781-C)
00025821 Bohn, W.R. (1974) CL 92, 553: Determination of N-(l-Ethylpropyl)-3,
4-dimethyl-2,6-dinitrobenzenamine| in Soybean Seed. Method
M-533 dated Jul 30, 1974. (Unpublished study received Feb 13,
1980 under 241-243; submitted by American Cyanamid Co., Prince-
ton, N.J.; CDL:241781-D)
00025822 Boughton, PJ. (1974) CL 92,553: Determination of N-(l-Ethylpro-
pyl)-3,4-dimethyl-2,6-dinitrobenzenamine in Soybean Green Seed.
Method M-560 dated Nov 12, 1974. (Unpublished study received
Feb 13, 1980 under 241-243; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:241781-E)
00025827 Bohn, W.R. (1974) CL 202,347: Determination of 4-0(1-Ethylpropyl)
arnino|-2-methyl-3,5-dinitro-benzyl alcohol in Soybean Seed.
Method M-536 dated Aug 6, 1974. (Unpublished study received
Feb 13, 1980 under 241-243; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:241781-K)
0025828 Boughton, P. (1975) CL 202,347: Determination of 4-0(1-Ethylpropyl)
amino |-2-methyl-3,5-dinitro-benzyl alcohol in Soybean Oil.
Method M-603 dated Apr 24, 1975. (Unpublished study received
Feb 13, 1980 under 241-243; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:241781-M)
146
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BIBLIOGRAPHY
MRID
CITATION
00025831 American Cyanamid Company (1974) CL 92,553: Determination of N-(l-
Ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine in Cottonseed.
Method M-476.1 dated Jun 6, 1974. (Unpublished study received
Feb 13, 1980 under 241-243; CDL:241781-R)
00025832 Boughton, P.J. (1974) CL 92,553: Determination of N-(l-Ethylpro-
pyl)-3,4-dimethyl-2,6-dinitrobenzenamine in Cottonseed Oil.
Method M-514 dated May 24, 1974. (Unpublished study received
Feb 13, 1980 under 241-243; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:241781-S)
00025833 Boughton, P.J. (1974) CL 92,553: Determination of N-(l-Ethyl pro-
pyl)-3,4-dimethyl-2,6-dinitrobenzenamine in Cotton Plants.
Method M-516 dated Jun 5, 1974. (Unpublished study received
Feb 13, 1980 under 241-243; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:241781-T)
00025831 American Cyanamid Company (1974) CL 92,553: Determination of N-(l-
Ethylpropyl)~3,4-dimethyl-2,6-dinitrobenzenamine in Cottonseed.
Method M-476.1 dated Jun 6, 1974. (Unpublished study received
Feb 13, 1980 under 241-243; CDL:241781-R)
00025832 Boughton, P.J. (1974) CL 92,553: Determination of N-(l-Ethyl pro-
pyl)-3,4-dimethyl-2,6-dinitrobenzenamine in Cottonseed Oil..
Method M-514 dated May 24, 1974. (Unpublished study received
Feb 13, 1980 under 241-243; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:241781-S)
00025833 Boughton, P.J. (1974) CL 92,553: Determination of N-(l-Ethylpro-
pyl)-3,4-dimethyl-2,6-dinitrobenzenamine in Cotton Plants.
Method M-516 dated Jun 5, 1974. (Unpublished study received
Feb 13, 1980 under 241-243; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:241781-T)
00026657 Morici, I.J.; Alford, B.T.; Babcock, C.N.; et al. (1972) eToxicity
Data for Technical Prowl on Animals |: Report A-72-4. (Unpub-
lished study received on unknown date under 4G1451; submitted
by American Cyanamid Co., Princeton, N.J.; CDL:093868-F)
147
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BIBLIOGRAPHY
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00026663 Feinman, H. (1973) Report: 21-Day Subacute Dermal Toxicity in Rab-
bits of AC-92553: Laboratory No. 1613. (Unpublished study re-
ceived on unknown date under 4(31451; prepared by Food and Drug
Research Laboratories, Inc., submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:093868-L)
00026673 Bailey, D.E.; Morgareidge, K. (1973) Dominant Lethal Study in Rats
with AC 92553: Laboratory No. 2006. (Unpublished study received
on unknown date under 4G1451; prepared by Food and Drug Research
Laboratories, Inc., submitted by American Cyanamid Co., Prince-
ton, N.J.; CDL:093868-V)
00026674 Fink, R. (1973) Final Report: Eight-Day Dietary LCae50---Mallard
Ducks: Project No. 362-138. (Unpublished study received on un-
known date under 4G1451; prepared by Hazleton Laboratories,
Inc., submitted by American Cyanamid Co., Princeton, N.J.;
CDL:093868-X)
00026675 Fink, R. (1973) Final Report: Eight-Day Dietary LCae50-'--Bobwhite
Quail: Project No. 362-137. (Unpublished study received on un-
known date under 4G1451; prepared by Hazleton Laboratories, sub-
mitted by American Cyanamid Co., Princeton, N.J.; CDL:093868-Y)
00029020 Wyckoff, J. (1973) CL 202-347: Determination of 4-0(1-Ethylpro-.
pyl)amino|-2-methyl-3,5-dinitro-benzyl alcohol in Corn Grain.
Method M-466 dated Oct 16, 1973. (Unpublished study received
on unknown date under 4G1451; submitted by American Cyanamid
Co., Princeton, N.J.; CDL:093869-E)
00029028 Wyckoff, J.C.; Bodnarchuk, D.; Van Scoik, W.S. (1973) Prowl (CL
92,553): Determinaton jzSsic | of CL 92,553...and CL 202,347...Res-
idues in Field Corn Plants: Report No. C-382. (Unpublished
study received on unknown date under 4G1451; submitted by Ameri-
can Cyanamid Co., Princeton, N.J.; CDL:093869-N)
00029029 Wyckoff, J.C.; Moyer, M; Bodnarchuk, D.; et al. (1973) Prowl (CL
92,553): Determination of CL 92,553...CL 202,347...Atra-
zine...and Bladex...Residues in Field Corn Tissues (Fodder and
Grain): Report No. C-401. (Unpublished study received on un-
148
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BIBLIOGRAPHY
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known date under 4G1451; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:093869-O)
00029028 Wyckoff, J.C.; Bodnarchuk, D.; Van Scoik, W.S. (1973) Prowl (CL
92,553): Determinaton ฃsic[ of CL 92,553...and CL 202,347...Res-
idues in Field Corn Plants: Report No. C-382. (Unpublished
study received on unknown date under 4G1451; submitted by Ameri-
can Cyanamid Co., Princeton, N.J.; CDL:093869-N)
00029029 Wyckoff, J.C.; Moyer, M.; Bodnarchuk, D.; et al. (1973) Prowl (CL
92,553): Determination of CL 92,553...CL 202,347... Atra-
zine...and Bladex...Residues in Field Corn Tissues (Fodder and
Grain): Report No. C-401. (Unpublished study received on un-,
known date under 4G1451; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:093869-O)
00029803 Marei, A.H.; Eisner, S.K. (1974) Prowl-(R)aeSoybean Metabolism:
Residual Radioactivity in Soybean Pods and Plants Grown in Soil
Treated with Carbon-14 Labeled CL 92,553: Report No. C-538.
(Unpublished study received Dec 21, 1974 under 5G1580; submitted
by American Cyanamid Co., Princeton, N.J.; CDL:094331-M)
t
00031212 Manuel, A.; Zulalian, J.; Steller, W.0980) Residues of Prowl Her-
bicide and Metabolites in Peanut Hulls: Report No. C-1645.1.
Summary of studies 099395-B through 099395-F. (Unpublished
study received Apr 29, 1980 under 241-243; submitted by American
Cyanamid Co., Princeton, N.J.; CDL:099395-A)
00031214 Smith, J. (1979) Prowl-(R)ae Pendimethalin (CL 92,553): Validation
of GC Method M-1029 for the Determination of CL 217,146 and CL
202,347 Residues in Peanut Hulls: Report No. C-1618. Includes
method M-1029 dated Oct 11, 1979. (Unpublished study received
Apr 29, 1980 under 241-243; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:099395-C)
00031215 Smith, J.; Lignowski, E.M.; Dunn, J.C.; et al. (1979) Prowl-(R)a?
Pendimethalin (CL 92,553/4E): Residues of CL 92,553, CL 202,347
and CL 217,146 in Peanut Hulls: Report No. C-1620. (Unpublished
149
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BIBLIOGRAPHY
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CITATION
study received Apr 29, 1980 under 241-243; submitted by American
Cyanamid Co., Princeton, N.J.; CDL:099395-D)
00031216 Smith, J.; Lignowski, E.M.; Walls, F.R., Jr.; et al. (1979)
Prowl-^ae Pendimethalin (CL 92,553/4E): Residues of CL 92,553,
CL 202,347 and CL 217,146 in Peanut Hulls: Report No. C-1631.
(Unpublished study received Apr 29, 1980 under 241-243; submit-
ted by American Cyanamid Co., Princeton, N.J.; CDL:099395-E)
00031217 Smith, J.; Lignowski, E.M.; Goddard, G.; et al, (1979) Prowl-(R)ae
Pendimethalin (CL 92,553/4E): Residues of CL 92,553, CL 202,347
and CL 217,146 in Peanut Hulls: Report No. C-1628. (Unpublished
study received Apr 29, 1980 under 241-243; submitted by American
Cyanamid Co., Princeton, N.J.; CDL:099395-F)
00031219 Marei, A.H.; Barringer, D.F., Jr.; Eisner, S.K. (1975) CL 92,553:
Metabolism XVI: Residual Radioactivity in Peanut Seeds and Foli-
age Grown in Soil Treated with Carbon-14 Labeled Prowl-i(R)ae Her-
bicidePD-M Volume 12: Project No. 2-460. (Unpublished study
. received Apr 29, 1980 under 241-243; submitted by American Cya-
narnid Co., Princeton, N.J.; CDL:099395-I)
00037927 Bentley, R.E. (1974) Acute Toxicity of Prowl-(TM)ae 3E, ProwH(TMae)
4E, and Avenge 2A-S to Bluegill (-pLepomis macrochirus-p) and
Rainbow Trout (-pSalmo gairdnerin~). (Unpublished study re-
ceived Nov 14, 1975 under 6F1703; prepared by Bionomics, EG&G,
Inc., submitted by American Cyanamid Co., Princeton, N.J.; CDL:
094732-H)
00037940 EG&G, Bionomics (1975?) Chronic Toxicity of CL-92,553 to the Fat-
head Minnow (Pimephales promelas). (Unpublished study received
Sep 8, 1977 under 241-243; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:096342-A)
00039518 American Cyanamid Company (1975) General Summary: Prowl Herbicide
and Its Metabolite Residues in Beans (Dry and Lima). Summary
of studies 095485-1 and 095485-J. (Unpublished study received
Feb 9, 1976 under 6G1739; CDL:095485-C)
150
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BIBLIOGRAPHY
MRID
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00039519 Boughton, P.J.; Potts, C.R. (1975) Prowl-(R)^ (CL 92,553): The Gas
Chromatographic. Determination of CL 92,553 0N-(l-Ethylpropyl)-3,
4-dimethyl-2,6-dinitrobenzenamine and CL 202,347 04-(01 -Ethyl-
propyl |amino)-2-methyl-3,5-dinitrobenzyl alcohol | from Fortified
Lima Bean Tissues (Foliage, Pods and Beans): Report No. C-793.
(Unpublished study received Feb 9, 1976 under 6G1739; submitted
by American Cyanamid Co., Princeton, N.J.; CDL:095485-D)
00039520 Boughton, P.J. (1975) CL 92,553: Determination of N-(l-Ethylpro-
pyl)-3,4-dimethyl-2,6-dintrobenzenamine in Lima Beans. Method
no. M-607 dated Jun 9, 1975. (Unpublished study received Feb 9,
1976 under 6G1739; submitted by American Cyanamid Co., Prince-
ton, N.J.; CDL:095485-E)
00039521 Boughton, P.J. (1975) CL 202,347: Determination of 4-0(1-Ethyl-
propyl)amino|-2-methyI-3,5-dinitro-benzyl alcohol in Lima Beans.
Method no. M-609 dated Jun 9, 1975. (Unpublished study received
Feb 9, 1976 under 6G1739; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:095485-G)
00039522 Boughton, P.J. (1975) CL 202,347: Determination of 4-0(1 -Ethyl-
propyl)amino |-2-methyl-3,5-dinitro benzyl alcohol in Lima Bean
Foliage and Pods. Method no. M-610 dated Jun 9, 1975. (Unpub-
lished study received Feb 9, 1976 under 6G1739; submitted by
American Cyanamid Co., Princeton, N.J.; CDL:095485-H)
00039523 Nzewi, G.I.; Devine, J.M.; Colbert, D.R.; et al. (1975) Prowl-(R)ffi
(CL 92,553): Determination of CL 92,553 0N-(l-Ethylpropyl)-3,4-
dimethyl-2,6-dinitrobenzenamine | and CL 202,347 0-(01 -Ethyl-
propyl |amino)-2-methyl-3,5-dinitro benzyl alcohol | in Lima
Beans: Report No. C-726. (Unpublished study received Feb 9,
1976 under 6G1739; submitted by American Cyanamid Co., Prince-
ton, N.J.; CDL:095485-I)
00039524 Devine, J.M.; Nzewi, G.I.; Colbert, D.R.; et al. (1975) Prowl-(R)a;
CL 92,553): Determination of CL 92,553 0N-(l-Ethylpropyl)-3,4-
dimethyl-2,6-dinitrobenzenamine| and CL 202,347 04~(01-Ethylpro-
pyl |amino) 2-methyl-3,5-dinitro benzyl alcohol | in Dry Beans
(Seeds and Straw): Report No. C-727. (Unpublished study re-
151
-------
BIBLIOGRAPHY
MRID
CITATION
ceived Feb 9, 1976 under 6G17.39; submitted by American Cyanamid
Co., Princeton, N.J.; CDL:095485-J)
00039526 Boughton, P.J.; Devine, J.M.; Laporata, M. (1975) Prowl-(R)se (CL
92,553): The Gas Chromatographic Determination of CL 92,553
01~N1__(l_Ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine | and
CL 202,347 04-(jiEthylpropyl |amino)-2-methyl-3,5-dinitrobenzyl
alcohol | from Fortified Potato Tissues (Tubers and Vines): Re-
port No. C-786. Includes method no. M-613 dated Jun 23, 1975.
(Unpublished study received Feb 9, 1976 under 6G1739; submitted
by American Cyanamid Co., Princeton, N.J.; CDL:095485-L)
00039527 Boughton, P.J. (1975) CL 92,553: Determination of~N~,-(l-Ethylpro-
pyl)-3,4-dimethyl-2,6-dinitrobenzenamine in Potato Vines.
Method no. M-614 dated Jun 23, 1975. (Unpublished study re-
ceived Feb 9, 1976 under 6G1739; submitted by American Cyanamid
Co., Princeton, N.J.; CDL:095485-M)
00039528 Boughton, P. (1975) CL 202,347: Determination of 4-0(l-Ethylpropyl)
amino |-2-methyl-3,5-dinitro benzyl alcohol in Potato Tubers.
Method no. M-615 dated Jun 23, 1975. (Unpublished study re-
ceived Feb 9, 1976 under 6G1739; submitted by American Cyanamid
Co., Princeton, N.J.; CDL:095485-N)
00039529 Boughton, P.J. (1975) CL 202,347: Determination of
4-0(1 -Ethyl-propyl)amino |-2-methyl-3,5-dinitro benzyl alcohol in Potato
Vines. Method no. M-616.dated Jun 23, 1975. (Unpublished study
received Feb 9, 1976 under 6G1739; submitted by American
Cyanamid Co., Princeton, N.J.; CDL:095485-O)
00039534 American Cyanamid Company (1975) Metabolism of Prowl Herbicide in
Lima Beans. Summary of study 095485-U. (Unpublished study
received Feb 9, 1976 under 6G1739; CDL:095485-T)
00039535 Adams, C.F.; Eisner, S.K. (1975) Prowl-{R)ae Herbicide Lima Bean
Metabolism: Residual Radioactivity in Lima Bean Pods and Plants
Grown in Soil Treated with Carbon-14 Labeled Prowl: Report
No. C-729. (Unpublished study received Feb 9, 1976 under
152
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BIBLIOGRAPHY
MRID
CITATION
6G1739; submitted by American Cyanamid Co., Princeton, N.J.;
CDL:095485-U)
00039537 Adams, C.F.; Eisner, S.K. (1975) ProwH(R)a; Herbicide, Potato Me-
tabolism: Residual Radioactivity in Potato Plants Grown in Soil
Treated with Carbon-14 Labeled Prowl: Report No. C-728. (Unpub-
lished study received Feb 9, 1976 under 6G1739; submitted by
American Cyanamid Co., Princeton, N.J.; CDL:095485-X)
00041897 American Cyanamid Company (1975) General Summary-Prowl Herbicide
Residues in Soybean Plants, Seeds, Oil, Meal and Soil. Summary
of studies 094648-B through 094648-J and 094648-L through
094648-O. (Unpublished study received Nov 20, 1975 under
6F1704; CDL:094648-A)
00041898 Boughton, P.J.; Bonn, R.; Tondreau, R.E. (1975) Prowl (CL 92,553):
The Gas Chromatographic Determination of CL 92,553 0N-(l-Ethyl-
propyl)-3,4-dimethyl-2,6-dinitrobenzenamine| and CL 202,347 (4-
01-Ethylpropyl | amino)-2-methyl-3,5-dinitro-benzyl alcohol | from
Fortified Soybean Tissues (Foliage, Green Seeds and Dry Seeds)
and Processed Commodities (Oil and Meal): Report No. C-539.1.
Summary of studies 094648-C through 094648-J and 094.648-L
through 094648-O. (Unpublished study received Nov 20, 1975 un-
der 6F1704; submitted by American Cyanamid Co., Princeton, N.J.;
CDL:094648-B)
00041901 Boughton, P.J. (1975) CL 92,553: Determination of N-(l-Ethyl pro-
pyl)-3,4-dimethyl-2,6-dinitrobenzenamine in Soybean Meal. Meth-
od M-604 dated Apr 24, 1975. (Unpublished study received Nov
20, 1975 under 6F1704; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:094648-F)
00041904 Boughton, P.J. (1974) CL 202,347: Determination of 4-0(1-Ethylpro-
pyl)amino |-2-methyl-3,5-dinitro benzyl alcohol in Soybean Green
Seed. Method M-561 dated Nov 12, 1974. (Unpublished study re-
ceived Nov 20, 1975 under 6F1704; submitted by American Cyanamid
Co., Princeton, N.J.; CDL:094648-I)
153
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BIBLIOGRAPHY
MRID
CITATION
00046275 Zulalian, J. (1973) CL 92,553: Metabolism III. Isolation and Iden-
tification of Metabolites Present in Urine, Feces, and Selected
Tissues of Rats Treated with Carbon-14 CL 92,553 0~N~-( 1 -Ethyl-
propyl)-2,6-dinitro-3,4-xylidine|, Prowl Herbicide: Project
No. 2-463. (Unpublished study received Sep 27, 1974 under
5F1556; submitted by American Cyanamid Co., Princeton, N.J.;
CDL-.094475-B)
00046278 Gatterdam, P.E.; Fasinski, R.; Tondreau, R.E. (1973) CL 92,553:
Metabolism II. Uptake and Residues of Radioactivity in Cotton
following Incorporation of Carbon-14 CL 92,553 in Soil: Project
No. 2-464. (Unpublished study received Sep 27, 1974 under
5F1556; submitted by American Cyanamid Co., Princeton, N.J.;
CDL:094475-E)
i
00046280 Kapoor, IP.; Eisner, S.K. (1974) CL 92,553: Metabolism VIII. Up-
take and Residues of Radioactivity in Cotton Grown in Soil
Treated with Carbon-14 Labeled Prowl Herbicide: Project No. 2-
464. Final rept. (Unpublished study received Sep 27, 1974
under 5F1556; submitted by American Cyanamid Co., Princeton,
N.J.; CDL:094475-G)
00046293 Kapoor, I.P.; Barringer, D.F., Jr.; Haugwitz, M.I.; et al. (1974)
Prowl Herbicide: Metabolism X. Isolation, Identification, and
Characterization of CL 92, 553 and Its Metabolites in Fish and
Its Aquatic Environment: Project No. 2-463. (Unpublished study
received Sep 27, 1974 under 5F1556; prepared in cooperation with
Bionomics EG&G, Inc., submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:094674.-G)
00051958 Boughton, PJ. (1975) Prowl-
-------
BIBLIOGRAPHY
MRID
CITATION
M-590 dated Apr 2, 1975. (Unpublished study received Feb 9,
1976 under 6G1740; submitted by American Cyanamid Co., Prince-
ton, N.J.; CDL:095393-E)
00051960 Boughton, P. (1975) CL 92,553: Determination of N-(l-Ethylpropyl)-
3,4-dimethyl-2,6-dinitrobenzenamine in Peanut Meal. Method M-
592 dated Apr 2, 1975. (Unpublished study received Feb 9, 1976
under 6G1740; submitted by American Cyanamid Co., Princeton,
N.J.; CDL:095393-F)
00051961 Boughton, P.J. (1975) CL 202,347: Determination of 4-0(1 -Ethylpro-
pyl)amino |-2-methyl-3,5-dinitro benzyl alcohol in Peanut Foli-
age, Hay and Hulls. Method M-580 dated Feb 18, 1975. (Unpub-
lished study received Feb 9, 1976 under 6G1740; submitted by
American Cyanamid Co., Princeton, N.J.; CDL:095393-H)
00051962 Boughton, P.J. (1975) CL 202,347: Determination of 4-0(1-Ethylpro-
pyl)amino |-2-methyl-3,5-dinitro-benzyl alcohol in Peanut Meal.
Method M-593 dated Apr 2, 1975. (Unpublished study received Feb
9, 1976 under 6G1740; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:095393-J)
00051963 Boughton, P.J.; Kust, C.A.; Potts, C.R.; et al. (1975) 0Peanut Res-
idue Studies |: Report No. C-675. (Unpublished study including
report nos. C-670, C-674, C-672..., received Feb 9, 1976 under
6G1740; prepared in cooperation with North Carolina State Univ.,
Agricultural Experiment Station, Dept. of Crop Science, Peanut
Belt Research Station, submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:095393-K)
00051965 Marei, A.H.; Barringer, D.F., Jr.; Eisner, S.K. (1975) CL 92,553:
Metabolism XVI: Residual Radioactivity in Peanut Seeds and Foli-
age Grown in Soil Treated with Carbon-14 Labeled Prowl-ฐ(R)ae Her-
bicide: Project No. 2-460. (Unpublished study received Feb 9,
1976 under 6G1740; submitted by American Cyanamid Co., Prince-
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00052558 Boughton, P.J. (1975) CL 92,553: Determination of N-(l-Ethylpro-
pyl)-3,4-dimethyl-2,6-dinitrobenzenamine in Lima Bean Foliage
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00058478 Oliver, I.E. (1978) Letter sent to Files dated Mar 22, 1978:
Analysis of soybean plant parts. (U.S. Agricultural Research
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00058657 Cueto, C., Jr.; Manus, A.G. (1979) Two-Year Toxicity Study in Dogs:
AC 92,553:LBI Project No. 20755. Final rept. (Unpublished
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00058657 Cueto, C., Jr.; Manus, A.G. (1979) Two-Year Toxicity Study in Dogs:
AC 92,553: LBI Project No. 20755. Final rept. (Unpublished
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00059468 Rapp, W.R.; Smith, J.M.; Kasner, J. (1973) A 3 and 24 Month Oral
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00059469 Tegeris, A.S. (1973) Final Report to ... on the Effect of Mammary
Glands of a Ninety-Day Male Rat Feeding Study with AC 92,553.
(Unpublished study received Dec 21, 1973 under unknown admin.
no.; prepared by Pharmacopathics Research Laboratories, Inc.,
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130681-M)
00059738 LeBlanc, G.A. (1976) Acute Toxicity of Prowl to~Daphnia magna-.
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156
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00059739 Fink, R. (1976) Final Report: Acute Oral LD50-Mallard Duck: Proj-
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00067283 American Cyanamid Company (1980) Summary of Residue Analysis for
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received Aug 25,,1980 under 241-243; CDL:099565-A)
00067288 Haugwitz, M.I.; Eisner, S.K. (1974) ProwH(TM)ae Herbicide: Residual
Radioactivity in Lactating Goats Treated with ->14asC-CL 92,553
0~N~-(l-Ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine :
PD-M 11:131-231. (Unpublished study received Aug 25, 1980 under
241-243; submitted by American Cyanamid Co., Princeton, N.J.;
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00067289 Goldhamer, R.E. (1973) Metabolism of-14seC-CL 92,553 Administered
in Capsules to Lactating Goats: Experiment Reference No. A-987;
PD-M 11:233-244. (Unpublished study received Aug 25, 1980 under
2,41-243; prepared by Biometric Testing, Inc., submitted by Amer-
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00067293 Marei, A.H.; Haugwitz, M.I.; Eisner, S.K. (1974) CL 92,553: Metabo-
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in Soil Treated with Carbon-14 CL 92,553: PD-M 11:376-416. Fi-
nal rept. (Unpublished study received Aug 25, 1980 under 241-
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099565-K)
00067519 Gustafson, R.H. (1976) Mutagenicity Tests of Typical Prowl-(R)^
Herbicide and of Minor Component CL 94,269. (Unpublished study
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00070962 American Cyanamid Company (1976) Summary of Residue Analysis of
Prowl in Peas. Includes methods M-597.1 dated Dec 6, 1976;
M-693 dated Jul 20, 1976; M-742 dated Dec 6, 1976 and M-694
dated Jul 20, 1976. (Compilation; unpublished study received
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157
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00071120 American Cyanamid Company (1980) Residues of Prowl Herbicide.
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00071121 Mangels, G.; Lucas, L. (1980) Prowl-(R)ae Pendimethalin (CL 92,553):
Residual Radioactivity in Rice Grain and Plants Treated Post-
emergence with Carbon-14 CL 92,553 Prowl: PD-M 17-12:1-22.
Final rept. (Unpublished study received Jan 22, 1981 under 241-
243; submitted by American Cyanamid Co., Princeton, N.J.; CDL:
099888-D)
00071123 Thompson, C.M.; Griffen, J.; McAllister, W.A. (1980) Acute Toxicity
of AC 92,553 to the Freshwater Crayfish (Procambarus simulans):
Static Acute Bioassay Final Report # 25725. (Unpublished study
received Jan 22, 1981 under 241-243; prepared by Analytical
Bio Chemistry Laboratories, Inc., submitted by American Cyanamid
Co., Princeton, N.J.; CDL:099889-B)
00071124 McAllister, WA.; Thompson, C.M.; Forbis, A.D.; et al. (1980) Resi-
due Accumulation Study in Crayfish (-Procambarus simulans-)
with -'HaeC-CL 92,553 (Pendimethalin) under Static Conditions:
Final Residue Accumulation Report # 25687. (Unpublished study
received Jan 22, 1981 under 241-243; prepared by Analytical Bio
Chemistry Laboratories, Inc., submitted by American Cyanamid
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00072802 American Cyanamid Company (1973) Toxicity Data: Prowl Herbicide,
Technical: Report A-73-133. (Unpublished study received Sep
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00072810 Boughton, P.J. (1975) CL 202,347: Determination of 4-0(1-Ethylpro-
pyl)amino|-2-methyl-3,5-dinitro-benzyl alcohol in Soybean Meal.
Method M-605 dated Apr 24, 1975. (Unpublished study received
Nov 20, 1975 under 6F1704; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:094648-L)
00072822 Boughton, P.J. (1975) CL 92,553: Determination of 0N-(1-Ethylpro-
pyl)-3,4-dimethyl-2,6-dinitrobenzenamine | in Peanuts. Method M-
577 dated Feb 18, 1975. (Unpublished study received Feb 9, 1976
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00072823 Boughton, P.J. (1975) CL 92,553: Determination of 0N-(1 -Ethylpro-
pyl)-3,4-dimethyl-2,6-dinitrobenzenamine| in Peanut Foliage, Hay
and Hulls. Method M-578 dated Feb 18, 1975. (Unpublished study
received Feb 9, 1976 under 6G1740; submitted by American Cyanam-
id Co., Princeton, N.J.; CDL:095393-D)
00072824 Boughton, P.J. (1975) CL 202,347: Determination of 4-0(1-Ethylpro-
pyl)amino |-2-methyl-3,5-dinitro-benzyl alcohol in Peanuts.
Method M-579 dated Feb 18, 1975. (Unpublished study received
Feb 9, 1976 under 6G1740; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:095393-G)
00072825 Boughton, P. (1975) CL 202,347: Determination of 4-0(l-Ethylpro-
pyl)amino|-2-methyl-3,5-dinitro-benzyl alcohol in Peanut Oil.
Method M-591 dated Apr 2, 1975. (Unpublished study received Feb
9, 1976 under 6G1740; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:095393-I)
00073342 Deprospo, J.R. (1973) Acute Inhalation Study of AC 92,553 in Rats:
Contract No. 122-1968-43. Final rept. (Unpublished study
received Dec 21, 1973 under unknown admin, no.; prepared by
Affiliated Medical Research, Inc., submitted by American Cyan-
amid Co., Princeton, N.J.; CDL:130681-H)
00074619 American Cyanamid Company (1977) Summary: Residues of Prowl, Its
Metabolite (CL 202,347), Atrazine and Bladex in or on Sweet
Corn. (Compilation; unpublished study received May 8, 1981 un-
der 241-EX-9 8; CDL: 070070-A)
Contract No. 122-1968-43. Final rept. (Unpublished study
received Dec 21, 1973 under unknown admin, no.; prepared by
Affiliated Medical Research, Inc., submitted by American Cyan-
amid Co., Princeton, N.J.; CDL: 130681-H)
00074621 Barringer, D.F., Jr.; Eisner, S. (1973) CL 92,553: Metabolism
IV. Uptake and Residues of Radioactivity in Sweet Corn Grown in
Soil Treated with Carbon-14 Labeled Prowl-fTM)ae Herbicide: PD-M
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10:584-629. Final rept. (Unpublished study, including submit-
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American Cyanamid Co., Princeton, N.J.; CDL:070070-D)
00081581 Boughton, P.J.; Potts, C.R. (1975) Prowl-(R)a; (CL 92,553): The Gas
Chromatographic Determination of CL 92,553 fz5~N~-(l-Ethylpro-
pyl)-3,4-dimethyl-2,6-dinitrobenzenamine | and CL 202,347 04-
(01-Ethylpropyl |amino)-2-methyl-3,5-dinitrobenzyl alcohol | from
Fortified Lima Bean Tissues (Foliage, Pods and Beans): Report
No. C-793. (Unpublished study received Sep 4, 1981 under 241-
243; submitted by American Cyanamid Co., Princeton, N.J.; CDL:
070293-R)
00093697 American Cyanajnid Company (1981) Residues of Prowl. Includes un-
dated method M-458.1; method M-465.1 dated May 9, 1974; method
M-459.1 dated May 9, 1974; and others. (Compilation; unpub-
lished study, including published data, received Jan 7, 1982
under 241-243; CDL:246583-A)
00093698 Mangels, G.; Lucas, L. (1981) Prowl-(TM)ป Pendimethalin (CL 92,
553): Residual Radioactivety in Corn Treated Postemergence In-
corporated with Carbon-14 CL 92,553 Prowl Herbicide: PD-M 18-6:
1-21. Final rept. (Unpublished study received Jan 7, 1982
under 241-243; submitted by American Cyanamid Co., Princeton,
N.J.; CDL:246583-B)
00093719 American Cyanamid Company (1981) Summary: Residues of Prowl, Its
Metabolite (CL 202,347), Atrazine and Bladex in or on Sweet
Corn. Includes undated method M-458.1; method M-465.1 dated
May 9, 1974; method M-459.1 dated May 9, 1974; and others.
(Compilation; unpublished study, including published data, re-
ceived Jan 15, 1982 under 241-243;.CDL:070600-A)
00093697 American Cyanamid Company (1981) Residues of Prowl. Includes un-
dated method M-458.1; method M-465.1 dated May 9, 1974; method
M-459.1 dated May 9, 1974; and others. (Compilation; unpub-
lished study, including published data, received Jan 7, 1982
under 241-243; CDL:246583-A)
160
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00093698 Mangels, G.; Lucas, L. (1981) Prowl-(TM)aj Pendimethalin (CL 92,
553): Residual Radioactivety in Corn Treated Postemergence In-
corporated with Carbon-14 CL 92,553 Prowl Herbicide: PD-M 18-6:
1-21. Final rept. (Unpublished study received Jan 7, 1982
under 241-243; submitted by American Cyanamid Co., Princeton,
N.J.; CDL:246583-B)
00100504 Graney, R.L. (1981) The Chronic (21 Day) Toxicity of AC 92,553 to
-pDaphnia magna-Straus: Project No. 5179. (Unpublished study
received Apr 20, 1982 under 241-243; prepared by Biospherics,
Inc., submitted by American Cyanamid Co., Princeton, N.J.; CDL:
247299-A)
00106751 American Cyanamid Co. (1974) The Name, Chemical Identity and Com-
position of Prowl Herbicide. (Compilation; unpublished study
received on unknown date under 5G1567; CDL:094283-A)
00106752 American Cyanamid Co. (1974) Extent of Prowl Herbicide and Its
Metabolite ResiduesCotton Plants, Seed, Oil, Meal and in
Milk, Including a Description of the Analytical Methods used.
(Compilation; unpublished study received on unknown date under
5G1567; CDL:094284-A)'
00106754 Morici, I.; Alford, B.; Babcock, C.; et al. (1972) Toxicology Re-
port on 3,4-Xylidine, N-(l-Ethylpropyl)-2,6-dinitro-; Acute
Studies and 30-day Feedings in Rats, Mice,, and Dogs. (CL 92,
553): Report No. 72-4. (Unpublished study received on unknown
date under 5G1567; submitted by American Cyanamid Co., Prince-
ton, NJ; CDL:094285-B)
00106764 Sleight, B. (1973) Acute Toxicity of AC-92553 to Bluegill (Lepomis
macrochirus), Rainbow Trout (Salmo gairdneri) and Channel Cat-
Fish (Ictaluras punctatus). (Unpublished study received on
unknown date under 5G1567; prepared by Bionomics, Inc., sub-
mitted by American Cyanamid Co., Princeton, NJ; CDL:094287-E)
161
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00106767 American Cyanamid Co. (1973) Toxicity Data: O-Toluic Acid, 4(01-
(Carboxymethyl) Propyl | Amino)-3,5-Dinitro-: Report A-73-72.
(Unpublished study received on unknown date under 5G1567; CDL:
094287-L)
00106779 American Cyanamid Co. (1974) (^Analyses for Residues of Prowl in
Sweet Corn and Other Crops |. (Compilation; unpublished study
received Sep 27, 1974 under 5F1556; CDL:094470-A)
00106785 American Cyanamid Co. (1975) Extent of Prowl Herbicide and Its
Metabolite Residues in Peanut Foliage, Hulls, Nuts, Oil and
Meal, Including a Description of the Analytical Methods Used.
(Compilation; unpublished study received Feb 9, 1976 under
6F1741; CDL:094960-A)
00106791 American Cyanamid Co. (1976) (^Residues of Prowl Herbicide in
Sorghum |. (Compilation; unpublished study received Jan 6, 1978
under 241 -EX-88; CDL:096712-A)
00106795 Zulalian, J.; Adams, C.; Eisner, S.; et al. (1978) CL 92,553: Re-
sidual Radioactivity in Potato Tubers Grown under Greenhouse and
Field Conditions in Soil Treated with Carbon-14 and a Mixture
of Carbon-13 and Carbon-14 Labeled Prowl Herbicide: PD-M
15-17:1-26. (Unpublished study received Oct 5, 1978 under 241-
243; submitted by American Cyanamid Co., Princeton, NJ; CDL:
097432-C)
00106797 American Cyanamid Co. (1978) Amounts of Residues of Prowl, Its
Metabolite (CL 202,347) Metribuzin (Sencor or Lexone) and Eptam
in or on Potatoes. (Compilation; unpublished study received
Oct 5, 1978 under 241-243; CDL:097433-A; 097434)
00106807 American Cyanamid Co. (1979) Residue Analysis of Prowl or Atrazine
in Grain Sorghum. (Compilation; unpublished study received Aug
14, 1979 under 241-243; CDL:098918-A)
00106808 American Cyanamid Co. (1979) Residues of Prowl Herbicide. (Compi-
lation; unpublished study received Sep 21, 1979 under 241-EX-95;
CDL:098994-A)
162
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00106820 American Cyanamid Co. (1978) Amounts of Residues of Prowl, Its
Metabolite (CL 202,347) Atrazine, and Bladex in or on Field
Corn. (Compilation; unpublished study received May 11, 1978
under 241-243; CDL:233898-A)
00106829 American Cyanamid Co. (1978) Residues of Prowl Herbicide. (Compi-
lation; unpublished study received Aug 14, 1979 under 241-243;
CDL:238944-B; 241020)
00106830 American Cyanamid Co. (1975) ^Analyses for Residues of Prowl
Herbicide in Wheat and Other Crops |. (Compilation; unpublished
study received Oct 29, 1979 under 241-243; CDL:241256-A)
00108317 Barringer, D.; Eisner, S. (1975) CL 92,553: Metabolism XIV. Uptake
and Residues of Radioactivity in Winter Wheat Grown in Soil
Treated with Carbon-14 Labeled Prowl Herbicide: PD-M 12: 402-
433. Progress rept, Nov 5, 1973 to Jan 7, 1975. (Unpublished
study received Sep 21, 1979 under 241 -EX-95; submitted by
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00114313 American Cyanamid Co. (1982) Residues of Prowl. (Compilation;
unpublished study received Sep 14, 1982 under 241-243; CDL:
248325-A)
00131772 Ward, G. (1983) Acute Toxicity of AC 92,553 Technical and Formulat-
ed to Embryos-larvae of Eastern Oysters ...: Report No. BP-83-
6-65; Project No. R95. (Unpublished study received Oct 28, 1983
under 241-1243; prepared by EG & G Bionomics, submitted by
American Cyanamid Co., Princeton, NJ; CDL:251601-A)
00131773 LeBlanc, G.; Sousa, J, (1983) Acute Toxicity of AC 92,553 to Chan-
nel Catfish ...: Report #BW-83-2-1361. (Unpublished study re-
ceived Oct 28, 1983 under 241-243; prepared by EG & G Bionomics,
submitted by American Cyanamid Co., Princeton, NJ; CDL:251601 -C)
00131774 Ward, G.; Shuba, P. (1983) Acute Toxicity of AC 92,553 Technical
and Formulation to Sheepshead Minnows ...: Report No. BP-83-3-
39; Project No. R95. (Unpublished study received Oct 28, 1983
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00131775 Ward, G.; Shuba, P. (1983) Acute Toxicity of AC 92,553 Technical
and Formulation to Pink Shrimp ...: Report No. BP-83-1-5; Pro-
ject No. R95. (Unpublished study received Oct 28, 1983 under
241-243; prepared by EG & G Bionomics, submitted by American Cy-
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00134355 American Cyanamid Co. (1980) Residues of Prowl Herbicide. (Com-
pilation; unpublished study received Jun 11, 1980 under 241-
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00152847 Cortes,'D (1985) Part II: Section 61-3, Discussion of the Forma-
tion of Impurities for the Manufacturing-use Product or Techni-
cal in Prowl Herbicide-Potential N-Nitrosamines in Pendimetha-
lin: Project No. 0166: Report No. 4. Unpublished study prepared
by American Cyanamid Co. 89 p.
00153762 American Cyanamid Co. (1985) Pendimethalin Registration Standard:
Volume I: Product Chemistry Data. Unpublished compilation.
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00153763 Sanders, P. (1985) Prowl Herbicide, Pendimethalin (AC 92,553):
Photodegradation in Water: Project No. 0166: Report No. PD-M
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Co. 32 p.
00153764 Mangels, G. (1985) Prowl Herbicide, Pendimethalin (AC 92,553):
Photodegradation on Soil: Project No. 0166: Report No. PD-M
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00153766 Sanders, P. (1985) Prowl Herbicide, Pendimethalin (AC 92,553):
Volatilization from Soil: Project No. 0166: Report No. PD-M
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00153767 Costello, B. (1985) Dermal Sensitization Study with AC 92,553 Lot#
AC 3528-129-1 in Guinea Pigs: Project No. 85-4639A. Unpublished
study prepared by Biosearch, Inc. 18 p.
00153768 Allen, J. (1985) Bacterial/Microsome Reverse Mutation (Ames) Test
on AC 92,553 (Lot AC 3528-129-1): Project No. 0166. Unpublished
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00153769 Stankowski, L. (1985) CHO/HGPRT Mammalian Cell Forward Gene Muta-
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00153770 SanSebastian, J. (1985) In vitro Chromosome Aberration Analysis in
Chinese Hamster Ovary (CHO) Cells: AC 92,553: PH 320-AC-001-85.
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00153771 Barfknecht, T. (1985) Rat Hepatocyte Primary Culture/DNA Repair
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00153772 Forbis, A.; Georgie, L.; Burgess, D. (1985) Acute Toxicity of AC
92,553 4E to Daphnia magna: Static Acute Toxicity Report #33409.
Unpublished study prepared by Analytical Bio-Chemistry
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00154789 American Cyanamid Co. (1982) Name, Chemical Identity and
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00156081 Fischer, J. (1986) AC 92,5.53: A 13-Week Rat Feeding Study: Project
No. 0166: Toxicology Report AX86-1. Unpublished study prepared
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Bioconcentration of fCarbon-14"-AC 92,553 by Bluegill Sunfish
(Lepomis macrochirus): Final Report #33408. Unpublished study
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00158235 Forbis, A.; Burgess, D.; Burnett, J. (1986) Uptake, Depuration and
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(Lepomis macrochirus): PD-M Volume 23-17; ABC Final Report
# 33408. Unpublished study prepared by Analytical Bio-Chemistry
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00158623 American Cyanamid Co. (1986) [Product Chemistry Data Requirements
for the Manufacturing-use Product or Technical in Prowl Herbi-
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Report No. C-2675. Unpublished study prepared by American
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Daphnia Magna Strauss: Project Number 5179. (Unpublished study received
April 20, 1982 under 241-243; prepared by Biosphericsm Inc., submitted
by American Cyanamid Co., Princeton, N. J.).
00251601 Sousa,J. V. 1983. Acute toxicity of AC 92,553 to channel
catfish (Ictalurus punctatus). Unpublished study prepared by
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prepared by International Research and Development Corp. 2052
P-
41111301 Wayne, R. (1989) Additional Data for the 62-Series Requirements.
Unpublished study prepared by American Cyanamid Co. 49 p.
41431001 Tondreau, R. (1986) Validation of Method M-1609 for the Determina-
tion of CL 92,553 and CL 202,347 Residues in Soybean Plants: Lab
Project Number: C-2667: M-1609. Unpublished study prepared by
American Cyanamid Co. 13 p.
167
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BIBLIOGRAPHY
MRID
CITATION
41469901 Chiu, T. (1990) Metabolism of 0Carbon-141 Labeled CL 92,553 in Soy-
bean jiPendithalin-PROWL Herbicide |. Unpublished study. 56 p.
41713901 Zulalian, J.; Lee, T.; Miller, P. (1990) Pendimethalin (AC92,553):
Disposition of 0carbon 14 (Labelled AC92,553 in Lactating Goat
and Characterization of the Residue in Goat Liver: Lab Project
Number: CY 37. Unpublished study prepared by American Cyanamid
Co. 195 p.
41725201 Wayne, R.; Johnson, R. (1989) Pendimethalin (Prowl): Additional
^Product Chemistry | Data. Unpublished study prepared by Ameri-
can Cyanamid Co. 14 p.
41725202 Mistretta, L.; Miller, P. (1990) Oral Teratology in Rats-Pendime-
thalin (AC 92, 553)-Individual Fetal Data: Lab Project Number:
362-155. Unpublished study prepared by Hazleton Labs America,
Inc. and American Cyanamid Co. 366 p.
41725203 Irvine, L.; Boughton, P. (1990) Pendimethalin: Dietary Rat Two-Gen-
eration Reproduction Toxicity Study with AC 92,553: Lab Project.
Number: CBG/2/90. Unpublished study prepared by Toxicol Labs
Ltd. and American Cyanamid Co. 717 p.
41827401 Baron, J. (1991) Pendimethalin: Magnitude of Residue on Onion (Dry
Bulb): Lab Project Number: 3528. Unpublished study prepared by
IR-4 Westren Region Analytical Laboratory. 142 p.
41845801 Devine, J. (1988) Freezer Storage Stability Data for Pendimethalin:
Addendum - Methods: Lab Project Numbers: C-2484: C-2380: CY 39.
Unpublished study prepared by American Cyanamid Co. 242 p.
41881201 Sisco, R. (1990) Prowl Herbicide (AC 92,553/4EC): Residues of
CL 92,553 and CL'202,347 in Cotton: Lab Project Number: C-3472:
C-3476: C-3485. Unpublished study prepared by American Cyanamid
Co. 182 p.
41909701 American Cyanamid Company (1985) Historical Control Data for Thyro-
id Neoplasm in the Sprague-Dawley Rat: Lab Project Number:. Unp-
ublished study prepared by American Cyanamid Company. 500 p.
168
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BIBLIOGRAPHY
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CITATION
41982701 American Cyanamid Co. (1986) Validation of Method M-1624 for the
Determination of CL 92,553 and CL 202,347 Residues in Wheat
Straw: Lab Project Number: C-2692: M-1624. Unpublished study.
13 p.
42027801 Putman, D.; Morris, M. (1991) Micronucleus Cytogenetic Assay in
Mice with AC 92,553 ^Prowl Herbicide |: Lab Project Number:
T9801.122004; 971-91-102. Unpublished study prepared by Micro-
biological Associates, Inc. 36 p.
42027802 Bailey, D. (1991) Effects of Chronic Dietary Administration of AC
92,553 on the Function and Structure of Male Rat Thyroids: Lab
Project Number: 362-191; 971-87-140. Unpublished study prepared
by Hazleton Labs America, Inc. 2366 p.
42054601 Fischer, J. (1991) 92-Day Thyroid Function Study in Albino Rats
with AC 92,553: Lab Project Number: T-0270. Unpublished study
prepared by American Cyanamid Co. 171 p.
42137101 Hughes, J.; Alexander, M.; Wisk, J. (1991) Effect of AC 92,553 on
Growth of Duckweed, Lemna gibba: Lab Project Number: B400-31-1.
Unpublished study prepared by Malcolm Pirnie, Inc. 60 p.
42266301 Bernstein, B. (1992) Summary of Previously Submitted Data in
Response to EPA Review of Storage Stability Related to
Guideline 171-4 Requirements: 0Prowl Herbicide] (Supp.).
Unpublished study prepared by American Cyanamid Co. 21 p.
42372201 Chetram, R.; Gagne, J. (1992) A Tier 2 Plant Phytotoxicity
Study for Seedling Emergence.Using AC 92,553: Pendimethalin:
Lab Project Number: BL91-453. Unpublished study prepared by
American Cyanamid Comp. and Pan-Agricultural Laboratories, Inc.
243 p.
42372202 White, T.; Gagne, J. (1992) A Tier 2 Plant Phytoxiciry Study
for Seed Germination Using AC 92,553: Pendimethalin: Lab
Project Number: BL91-471. Unpublished study prepared by
American Cyanamid Comp. and Pan-Agricultural Laboratories, Inc.
131 p.
169
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BIBLIOGRAPHY
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CITATION
42372203 Canez, V; Gagne, J. (1992) A Tier 2 Plant Phytoxicity Study for
Vegetative Vigor Using AC 92,553: Pendimethalin: Lab Project
Number: BL91-454. Unpublished study prepared by American
Cyanamid Comp. and Pan-Agricultural Laboratories, Inc. 212 p.
42372204 Hughes, J.; Alexander, M.; Wisk, J. (1992) Effect of AC 92,553
on Growth of the Green Alga, Selenastrum Capricornutum:
Pendimethalin: Lab Project Number: B400-32-1. Unpublished
study prepared by American Cyanamid Comp. and Malcolm Pirnie,
Inc. 58 p.
42372205 Hughes, J.; Alexander, M.; Wisk, J. (1992) Effect of AC 92,553 -
on Growth of the Marine Diatom, Skeletonema Costatum:
Pendimethalin: Lab Project Number: B400-32-4. Unpublished
study prepared by American Cyanamid Comp. and Malcolm Pirnie,
Inc. 53 p.
42372206 Hughes, J.; Alexander, M.; Wisk, J. (1992) Effect of AC
92,553 on Growth of the Freshwater Diatom, Navicula
Pelliculosa: Pendimethalin: Lab Project Number: B400-32-3.
Unpublished study prepared by American Cyanamid Comp. and
Malcolm Pirnie, Inc. 53 p.
42372207 Hughes, J.; Alexander, M.; Wisk, J. (1992) Effect of AC
92,553 on Growth of the Blue-Green Alga, Anabaena Flos-Aquae:
Pendimethalin: Lab Project Number: B400-32-2. Unpublished
study prepared by American Cyanamid Comp. and Malcolm Pirnie,
Inc. 60 p.
42467801 Zdybak, J. (1992) Pendimethalin (CL 92,553): Metabolism of
Carbon-14 Labeled CL 92,553 in Potatoes under Field Conditions:
Lab Project Number: PD-M 29-39. Unpublished study prepared by
XenoBiotic Labs, Inc. and Pan-Agricultural Labs, Inc. 116 p.
42467802 Zdybak, J. (1992) Pendimethalin (CL 92,553): Metabolic Fate of
Carbon-14 Labeled CL 92,553 in Tissues and Eggs of the Laying
Hen: Lab Project Number: PD-M 29-40. Unpublished study
prepared by XenoBiotic Labs, Inc. and Hazleton Wise., Inc.
187 p.
170
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BIBLIOGRAPHY
MRID
CITATION
42471901 Tondreau, R.; Boyd, J. (1992) Addendum: Soybean Residue
Studies with Prowl Herbicide (Concurrent recovery tests from
Soybean Hay): Lab Project Number: C2827: C2828: C2676.
Unpublished study prepared by American Cyanamid Co. 5 p.
42471902 Witkonton, S. (1992) Pendimethalin (CL 92,553): Characteristics
of Pendimethalin and its Alcohol Metabolite (CL 202,347)
Through FDA Multiresidue Methods: Lab Project Number: C-3852.
Unpublished study prepared by American Cyanamid Co. 61 p.
42471903 Witkonton, S. (1992) Pendimethalin (CL 92,553): Freezer
Stability of CL 92,553 and CL 202,347 in Alfalfa Green Forage,
Hay, and Seed Over a 24-Month Period: Lab Project Number:
C-3873. Unpublished study prepared by American Cyanamid Co.
63 p.
42686401 Zdybak, J. (1993) Pendimethalin (CL 92,553): Metabolism of
(carbon 14)-CL 92,553 in Sweet Corn under Field Conditions: Lab
Project Number: XBL 91045: RPT00114: M91P553CA1. Unpublished
study prepared by XenoBiotic Labs, Inc. in coop with Pan-Agri-
cultural Labs, Inc. 263 p.
42858901 Sisco, R. (1990) Prowl Herbicide: Residues of CL92,553 and
CL202,347 in Cotton: Additional Data: Lab Project Number:
MRID#41881201. Unpublished study prepared by American Cyanamid
Co. 68 p.
42859201 Schaefer, T. (1992) CL 92,553 (Pendimethalin): Residues of CL
92,553 and its Metabolite CL 202,347 in the Cane of Sugarcane
Grown in Hawaii after Sequential Applications of PROWL 4EC
Herbicide: Lab Project Number: C 3866. Unpublished study
prepared by American Cyanamid Co. 76 p.
42859202 Reliford, B. (1993) PROWL (CL 92,553) and Alcohol Plant
Metabolite (CL 202,347): Validation of GC Method M 2140 for the
Determination of CL 92,553 and CL 202,347 in Sugar Cane and
Sugar Cane Forage: Lab Project Number: C 3730. Unpublished
study prepared by American Cyanamid Co. 58 p.
171
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BIBLIOGRAPHY
MRID
CITATION
43041901 Mangels, G. (1993) Pendimethalin (AC 92,553):
Adsorption/Desorption on Japanese Soils: Lab Project Number:
PD/M/28/11: PD/M: E/90/3. Unpublished study prepared by
American Cyanamid Co. 37 p.
43068501 Witkonton, S. (1993) Recommended Method of Analysis: SOP
M1930.1 Herbicide, pendimethalin (CL 92,553): Determination
of CL 92,553 and CL 202,347 (Metabolite) Residues in Alfalfa
Greeh Forage, Alfalfa Seed, Alfalfa Hay and Processed Meal:
Lab Project ID: M1930.01. Unpublished study prepared by
American.Cyanamid Co. 23 p.
43135001 Fischer, J. (1993) 56-Day Thyroid Function Study in Albino Rats
with AC 92,553: Pendimethalin: Lab Project Number: AX93/1:
L/2366. Unpublished study prepared by American Cyanamid Co.
235 p.
43135003 DeVito, W.; Braverman, L. (1993) A 14-Day Intrathyroidal
Metabolism Study in Male Rats with AC 92,553: Pendimethalin:
Lab Project Number: UM/91/06/01: 971/91/112. Unpublished study
prepared by University of Massachusetts Medical School. 57 p.
43135006 San, R.; Klug, M. (1993) AC 92,553: Salmonella/Mammalian-
Microsome Plate Incorporation Mutagenicity Assay (Ames Test)
and Escherichia coli WP2 uvrA Reverse Mutation Assay with a
Confirmatory Assay: Pendimethalin: Lab Project Number:
TC892/501114: 971/93/101. Unpublished study prepared by
Microbiological Assoc., Inc. 83 p.
43135007 San, R.; Raabe, H. (1993) AC 92,553: Detection of Single Strand
Breaks, DNA/DNA and DNA/ Protein Cross Links in Rat Testicular
DNA by Alkaline Elution: Pendimethalin: Lab Project Number:
TC724/396: 971/92/124. Unpublished study prepared by
Microbiological Assoc., Inc. 75 p.
43147801 Stout, S. (1990) Pendimethalin (CL 92,553): Validation of GC/
MS Method SOP M2007 for the Confirmation of CL 92,553 and CL
202,347 in Alfalfa (Green Forage, Seed and Hay): Lab Project
172
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BIBLIOGRAPHY
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CITATION
Number: C/3386. Unpublished study, prepared by American
Cyanamid Co. 27 p.
43 154701 Mangels, G.; Ahmed, Z. (1994) Pendimethalin Registration
Standard-Response to EFGWB Review. Unpublished study prepared
by American Cyanamid Co. 88 p.
43 154702 Mangels, G. (1991) Pendimethalin (AC 92, 553): Anaerobic
Aquatic Degradation in Static Canadian Pond Water: Lab Project
Number: PD-M 28-5: E-89-30: 0466. Unpublished study prepared
by American Cyanamid Co. 1 17 p.
43 1 54704 Tondreau, R.; Pickard, G. (1 994) Pendimethalin Registration
StandardResponse to Review of Soybean (Hay) Residue Study:
Lab Project Number: C2827: C2828: C2676. Unpublished study
prepared by American Cyanamid Co. 18 p.
43 154705 Ahmed, Z. (1994) Pendimethalin Registration Standard-Response
to Review of Sweet Corn Metabolism Study. Unpublished study
prepared by American Cyanamid Co. 29 p.
43 177802 Stankowski, L. (1993) CHO/HGPRT Mammalian Cell Forward Gene
Mutation Assay on AC 92,553: Lab Project Number: PH
3 14-AC-002-85: 980-85-172. Unpublished study prepared by
Pharmakon Research International, Inc. 73 p.
43185901 Reliford, B. (1994) CL 92,553 (Pendimethalin): Radiovalidation
of GC Method M458.1: Supplement: Lab Project Number: RES/94/
021. Unpublished study prepared by American Cyanamid Co. 51
43808201 Ta, C. (1995) Aqueous Photolysis of Ac 92-553: Lab Project Number:
ENV 95-028: E-95-04. Unpublished study prepared by American
Cyanamid Co. 99 p.
44106801 American Cyanamid Co. (1996) Response to HED's Draft Science Chapter
for the Pendimethalin RED Document Toxicology Assessment: Lab Project
Number: CY-132: 361-084: 20755. Unpublished study. 178 p.
173
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BIBLIOGRAPHY
MRID
CITATION
44106803 American Cyanamid Co. (1996) Response to Review of Teratology Study
in Rats and Rabbits with AC 92,553: Lab Project Number: 362-155: 362-164:
362-163. Unpubished study. 22 p.
44106804 Wolfe, G.; Mis.tretta, L; Durloo, R. (1982) Teratology Study in Rabbits with AC
92,553 Technical: Individual Fetal Data: Lab Project Number: 362-164.
Unpublished study prepred by Hazelton Labs America, Inc. and American
Cyanamid Co. 329 p.
174
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
JUU 30 1997
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status Sheet,
to submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your product(s)
containing this active ingredient. Within 90 days after you receive this Notice you must
respond as set forth in Section IE below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its Attachments
1 through 7; or
2. Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3 (for both generic and product specific data), the Requirements Status and
Registrant's Response Form, (see section ffl-B); or
3. Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section ni-D).
. If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-In Response Forms. Also included is a list of all
registrants who were sent this Notice (Attachment 5).
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
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information is authorized under the Paperwork Reduction Act by OMB Approval No.
2070-0107 and 2070-0057 (expiration date 3-31-99).
This Notice is divided into six sections and seven Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You are Receiving this Notice
Section II - Data Required by this Notice
Section HI - Compliance with Requirements of this Notice
Section IV - Consequences of Failure to Comply with this Notice
Section V - Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Section VI - Inquiries and Responses to this Notice
The Attachments to this Notice are:
1 - Data Call-in Chemical Status Sheet
2 - Generic Data Call-In and Product Specific Data Call-In Response Forms with
Instructions (Form A)
3 - ' Generic Data Call-In and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions (Form B)
4- EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because
you have product(s) containing the subject active ingredients.
SECTION n. 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
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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 ง 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR ง 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001 L
Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160].
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 HI. 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
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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 ffl-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 up6n 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'^ Response Forms also must be submitted if
you do not qualify for a Generic Data Exemption" or are not requesting voluntary cancellation
of your registration(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(s). If you
choose this option, these are the only forms that you are required to complete.
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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.
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.
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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 ni-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 m-D.l. of this Notice and are covered
by options 8 and 9 of item 9 in the instructions for the Requirements Status and Registrant's
Response Form. If you choose one of these options, you must submit both 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 in-C.2. A discussion of
options relating to requests for data waivers is contained in Section in-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
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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 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 IIf-C.2. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the product specific Requirements Status and
Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product specific
data requirements for an MUP or EUP as applicable) on the product specific Data Call-in
Response Form. Note that the options available for addressing product specific data
requirements differ slightly from those options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements. It is important to ensure that you are using the correct
forms and instructions when completing your response to the Reregistration Eligibility
Decision document.
c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section III-D.2. of this Notice and are
covered by option 7 of item 9 in the instructions for the Requirements Status and Registrant's
Response Form. If you choose this option, you must submit the Data Call-In Response Form
and the Requirements Status and Registrant's Response Form as well as any other
information/data pertaining to the option chosen to address the data requirement. Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
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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 hi parentheses to guide you to additional instructions
provided in this Section. The options are:
(1) I will generate and submit data within the specified timeframe (Developing
Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) 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
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
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developing that study. This 90-day progress report must include the date the study was or will
be initiated and, for studies to be started within 12 months of commitment, the name and
address of the laboratory(ies) or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year, interim
reports must be submitted at 12 month intervals from the date you are required to commit to
generate or otherwise address the requirement for the study. In addition to the other
information specified in the preceding paragraph, at a minimum, a brief description of current
activity on and the status of the study must be included as well as a full
description of any problems encountered since the last progress report.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports or protocols.
The noted deadlines run from the date of the receipt of this Notice by the registrant. If the data
are not submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to
Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis.
You must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original
deadline remains. The Agency will respond to your request in writing. If EPA does not grant
your request, the original deadline remains. Normally, extensions can be requested only in
cases of extraordinary testing problems beyond the expectation or control of the registrant.
Extensions will not be given in submitting the 90-day responses. Extensions will not be
considered if the request for extension is not made in a timely fashion; in no event shall an
extension request be considered if it is submitted at or after the lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the cost of producing the required data
but will not be submitting the data yourself, you must provide the name of the registrant who
will be submitting the data. You must also provide EPA with documentary evidence that an
agreement has been formed. Such evidence may be your letter offering to join in an agreement
and the other registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the terms of the
final arrangement between the parties or the mechanism to resolve the terms. Section
3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they may
resolve their differences through binding arbitration.
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Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful, you
may request EPA (by selecting this option) to exercise its discretion not to suspend your
registration(s), although you do not comply with the data submission requirements of this
Notice. EPA has determined that as a general policy, absent other relevant considerations, it
will not suspend the registration of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but the other
registrant(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).
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.
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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 Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
NTIS). A study not conducted according to the PAG may be submitted to the Agency
for consideration if the registrant believes that the study clearly meets the purpose of
the PAG. The registrant is referred to 40 CFR 158.70 which states the Agency's policy
regarding acceptable protocols. If you wish to submit the study, you must, in addition
to certifying that the purposes of the PAG are met by the study, clearly articulate the
rationale why you believe the study meets the purpose of the PAG, including copies of
any supporting information or data. It has been the Agency's experience that studies
completed prior to January 1970 rarely satisfied the purpose of the PAG and that
necessary raw data usually are not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed
in the final protocol and study.
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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.
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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 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)
(3) 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 HI.C.I, Option 1) except that normally
no protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data If you enter into an agreement to cost
share, the same requirements apply to product specific data as to generic data (see Section
III.C.I, Option 2). However, registrants may only choose this option for acute toxicity data
and certain efficacy data and only if EPA has indicated in the attached data tables that your
product and at least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which data will be submitted must be noted
in the agreement to cost share by the registrant selecting this option.
Option 3. Offer to Share in the Cost of Data Development --The same requirements for
generic data (Section III.C.I., Option 3) apply to this option. This option only applies to acute
toxicity and certain efficacy data as described in option 2 above.
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Option 4. Submitting an Existing Study The same requirements described for generic data
(see Section in.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 (in.C.l.), as appropriate.
III-D REQUESTS FOR DATA WAIVERS
1. Generic Data
There are two types of data waiver responses to this Notice. The first is a request for a
low volume/minor use waiver and the second is a waiver request based on your belief that the
data requirement(s) are not appropriate for your product.
a. Low Volume/Minor Use Waiver
Option 8 under item 9 on the Requirements Status and Registrant's Response Form.
Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of requiring
data for low volume, minor use pesticides. In implementing this provision, EPA considers
low volume pesticides to be only those active ingredients whose total
production volume for all pesticide registrants is small. In determining whether to grant a low
volume, minor use waiver, the Agency will consider the extent, pattern and volume of use, the
economic incentive to conduct the testing, the importance of the 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:
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(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 produces) containing the active ingredient by year for the past five
years. Exclude all non-recurring costs that were directly related to the active ingredient,
such as costs of initial registration and any data development.
(v) A.list of each data requirement for which you seek a waiver. Indicate the type of
waiver sought and the estimated cost to you (listed separately for each data requirement
and associated test) of conducting the testing needed' to fulfill each of these data
requirements.
(vi) A list of each data requirement for which you are not seeking any waiver and the
estimated cost to you (listed separately for each data requirement and associated test) of
conducting the testing needed to fulfill each of these data requirements.
(vii) For each of the next ten years, a year-by-year forecast of company sales (pounds
and dollars) of the active ingredient, direct production costs of product(s) containing the
active ingredient (following the parameters in item 2 above), indirect production costs of
product(s) containing the active ingredient (following the parameters in item 3 above), and
costs of data development pertaining to the active ingredient.
(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.
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Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the request
for a waiver.
b. Request for Waiver of Data
Option 9, under Item 9, on the Requirements Status and Registrant's Response Form.
This option may be used if you believe that a particular data requirement should not apply
because the requirement is inappropriate. You must submit a rationale explaining why you
believe the data requirements should not apply. You also must submit the current label(s)
of your product(s) and, if a current copy of your Confidential Statement of Formula is not
already on file you must submit a current copy.
You will be informed of the Agency's decision in writing. If the Agency determines
that the data requirements of this Notice are not appropriate to your product(s), you will
not be required to supply the data pursuant to section 3(c)(2)(B). If EPA determines that
the data are required for your product(s), you must choose a method of meeting the
requirements of this Notice within the time frame provided by this Notice. Within 30 days
of your receipt of the Agency's written decision, you must submit a revised Requirements
Status and Registrant's Response Form indicating the option chosen.
2. Product Specific Data
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note:
any supplemental data must be submitted in the format required by PR Notice 86-5). This
will be the only opportunity to state the reasons or provide information in support of your
request. If the Agency approves your waiver request, you will not be required to supply
the data pursuant to section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver
request, you must choose an option for meeting the data requirements of this Notice within
30 days of the receipt of the Agency's decision. You must indicate and submit the option
chosen on the product specific Requirements Status and Registrant's Response Form.
Product specific data requirements 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 question. Waiver
requests submitted without adequate supporting rationale will be denied and the original
due date will remain in force.
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SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS 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 ffl-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
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Hi. Otherwise take appropriate steps to meet .the requirements stated in this Notice,
unless you commit to submit and do submit the required data in the specified time
frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
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 QR 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
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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 produces) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due, unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3-year study is scheduled to be submitted, all progress
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
193
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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,
A. Rossi, Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are:
1 - Data Call-in Chemical Status Sheet
2 - Generic Data Call-In and 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 Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Confidential Statement of Formula, Cost Share and Data Compensation Forms
194
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PENDIMETHALIN DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing PENDIMETHALIN.
This Product Specific Data Call-in Chemical Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
PENDIMETHALIN. This attachment is to be used in conjunction with (1) the Product Specific
Data Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3)
the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and
(7) the Cost Share and Data Compensation Forms in replying to this PENDIMETHALIN Product
Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for PENDIMETHALIN
are contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency
has concluded that additional data on PENDIMETHALIN are needed for specific products. These
data are required to be submitted to the Agency within the time frame listed. These data are
needed to fully complete the reregistration of all eligible PENDIMETHALIN products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Jane Mitchell at (703) 308-8061.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Jane Mitchell
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
' Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: PENDIMETHALIN
195
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PENDIMETHALIN DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s) containing
PENDIMETHALIN.
This Generic 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
PENDIMETHALIN. This attachment is to be used in conjunction with (1) the Generic Data Call-
in Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the Requirements
Status and Registrant's. Form (Attachment 2), (4) a list of registrants receiving this DCI
(Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and Data
Compensation Forms in replying.to this PENDIMETHALIN Generic Data Call In (Attachment
F). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for
PENDIMETHALIN are contained in the Requirements Status and Registrant's Response.
Attachment C. The Agency has concluded that additional product chemistry data on
PENDIMETHALIN are needed. These data are needed to.fully complete the reregistration of all
eligible PENDIMETHALIN products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures established
by this Notice, please contact Jane Mitchell at (703) 308-8061.
All responses to this Notice for the generic data requirements should be submitted to:
Jane Mitchell, Chemical Review Manager
Reregi stration Branch
Special Review and Registration Division (H7508W)
Office of Pesticiafde Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: PENDIMETHALIN
196
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Instructions For Completing The "Data Call-in Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
x 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. If you are an end-use product registrant only and have been sent this DCI
letter as part of a RED document you have been sent just the product specific "Data Call-In
Response Forms." Only registrants responsible for generic data have been sent the generic
data response form. The type of Data Call-In (generic or product specific) is indicated in
item number 3 ("Date and Type of DCI") on each form.
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 Agenpy, 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.
197
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 1. ON BOTH FORMS This item identifies your company name, number and
address.
Item 2. ON 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 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.
198
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
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.
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 BOTH MUP and EUP products
For each end use product (EUP) for which you wish to maintain registration,
you must agree to satisfy the data requirements by responding "yes."
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); dp 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.
199
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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 11. ON BOTH FORMS: Enter the phone number of your company contact.
Note: You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you
may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant details so that EPA can ensure that its records are correct.
200
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Instructions For Completing The "Requirements Status and Registrant's Response
Forms" For The Generic and Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Requirements Status and
Registrant's Response Forms" and are to be used.by registrants to respond to generic and
product specific Data Call-in's as part of EPA's reregi strati on program under the Federal
Insecticide, Fungicide, and Rodenticide Act. If you are an end-use product registrant only
and have been sent this DCI letter as part of a RED document you have been sent just the
product specific "Requirements Status and Registrant's Response Forms." Only registrants
responsible for generic data have been sent the generic data response forms. The type of
Data Call-In (generic or product specific) is indicated in item number 3 ("Date and
Type of DCI") on each form.
Although the form is the same for both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for satisfying product specific data
requirements do not include (1) deletion of uses or (2) request for a low volume/minor use
waiver. Please read these instructions carefully before filling out the forms.
EPA has developed these forms individually for each registrant, and has preprinted these
forms to include certain information unique to this chemical. DO NOT use these forms for
any other active ingredient.
Items 1 through 8 have been preprinted on the form. Item 9 must be completed by the
registrant as appropriate. Items 10 through 13 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average 30
minutes per response, including time for reviewing instructions, searching existing data
sources, 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.
201
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
Item 1. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2. ON THE GENERIC DATA FORM: This item identifies the case number,
case name, EPA chemical number and chemical name.
ON THE PRODUCT SPECIFIC DATA FORM:This item identifies the case
number, case name, and the EPA Registration Number of the product for which the
Agency" is requesting product specific data.
Item 3. ON THE GENERIC DATA FORM: This item identifies the type of Data
Call-in. The date of issuance is date stamped.
ON THE PRODUCT SPECIFIC DATA FORM:This item identifies the type of
Data Call-in. The date of issuance is also date stamped. Note the unique identifier
number (DD#) assigned by the Agency. This ID number must be used in the
transmittal document for any data submissions in response to this Data Call-In Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline reference number of
studies required. These guidelines, in addition to the requirements specified in
the Data Call-In Notice, govern the conduct of the required studies. Note that
series 61 and 62 in product chemistry are now listed under 40 CFR 158.155
through 158.180, Subpartc.
Item 5. ON BOTH FORMS: This item identifies the study title associated with the
guideline reference number and whether protocols and 1, 2, or 3-year progress
reports are required to be submitted in connection with the study. As noted in
Section El of the Data Call-In Notice, 90-day progress reports are required for
all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's Response
Form.
202
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
Item 6. ON BOTH FORMS: This item identifies the code associated with the use
pattern of the pesticide. In the case of efficacy data (product specific
requirement), the required study only pertains to products which have the use sites
and/or pests indicated. A brief description of each code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
ON BOTH FORMS: This item identifies the code assigned to the substance
that must be used for testing. A brief description of each code follows:
Item 7.
.EUP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TEP/MET
TEP/PAI/M
TGAI
TGAI/PAI
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade Active Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active Ingredient and Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active Ingredient
203
-------
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active Ingredient
TGAI/TEP
MET
IMP
DEGR
*
Radiolabelled
Technical Grade Active Ingredient or Typrcal End-Use Product
Metabolites
Impurities
Degradates
See: guideline comment
Item 8. This item completed by the Agency identifies the time frame allowed for
submission of the study or protocol identified in item 5.
ON THE GENERIC DATA FORM: The time frame runs from the date of your
receipt of the Data Call-In notice.
ON THE PRODUCT SPECIFIC DATA FORM:The due date for submission of
product specific studies begins from the date stamped on the letter transmitting the
Reregistration Eligibility Decision document, and not from the date of receipt.
However, your response to the Data Call-In itself is due 90 days from the date of
receipt.
Item 9. ON BOTH FORMS: Enter the appropriate Response Code or Codes to show
how you intend to comply with each data requirement. Brief descriptions of
each code follow. The Data Call-In Notice contains a fuller description of each
of these options.
Option 1. ON BOTH FORMS: (Developing Data) I will conduct a new study and
submit it within the time frames specified in item 8 above. By indicating that I
have chosen this option, I certify that I will comply with all the requirements
pertaining to the conditions for submittal of this study as outlined in the Data
Call-In Notice and that I will provide the protocols and progress reports
required in item 5 above.
Option 2. ON BOTH FORMS: (Agreement to Cost Share) I have, entered into an
agreement with one or more registrants to develop data jointly. By indicating
that I have chosen this option, I certify that I will comply with all the
requirements pertaining to sharing in the cost of developing data as outlined in
the Data Call-in Notice.
However, for Product Specific Data,! understand that this option is
available for acute toxicity or certain efficacy data ONLY if the Agency
indicates in an attachment to this notice that my product is similar enough to
another product to qualify for this option. I certify that another party in the
agreement is committing to submit or provide the required data; if the required
study is not submitted on time, my product may be subject to suspension.
204
-------
Option 3. ON BOTH FORMS: (Offer to Cost Share) I have made an offer to enter into
an agreement with one or more registrants to develop data jointly. I am also
submitting a completed "Certification of offer to Cost Share in the
Development of Data" form. I am submitting evidence that I have made an
offer to another registrant (who has an obligation to submit data) to share in the
cost of that data. I am including a copy of my offer and proof of the other
registrant's receipt of that offer. I am identifying the party which is committing
to submit or provide the required data; if the required study is not submitted on
time, my product may be subject to suspension. I understand that other terms
under Option 3 in the Data Call-In Notice apply as well.
However, for Product Specific Data, I understand that this option is
available only for acute toxicity or certain efficacy data and only if the Agency
indicates in an attachment to this Data Call-in Notice that my product is similar
enough to another product to qualify for this option.
Option 4. ON BOTH FORMS: (Submitting Existing Data) I will submit an existing
study by the specified due date that has never before been submitted to EPA.
By indicating that I have chosen this option, I certify that this study meets all
the requirements pertaining to the conditions for submittal of existing data
outlined in the Data Call-In Notice and I have attached the needed supporting
information along with this response.
Option 5. ON BOTH FORMS: (Upgrading a Study) I will submit by the specified due
date, or will cite data to upgrade a study that EPA has classified as partially
acceptable and potentially upgradeable. By indicating that I have chosen this
option, I certify that I have met all the requirements pertaining to the conditions
for submitting or citing existing data to upgrade a study described in the Data
Call-In Notice. I am indicating on attached correspondence the Master Record
Identification Number (MRID) that EPA has assigned to the data that I am
citing as well as the MRID of the study I am attempting to upgrade.
Option 6. ON BOTH FORMS: (Citing a Study) I am citing an existing study that has
been previously classified by EPA as acceptable, core, core minimum, or a
study that has not yet been reviewed by the Agency. If reviewed, I am
providing the Agency's classification of the study.
However, for Product Specific Data, I am citing another registrant's
study. I understand that this option is available ONLY for acute toxicity or
certain efficacy data and ONLY if the cited study was conducted on my
product, an identical product or a product which the Agency has "grouped"
with one or more other products for purposes of depending on the same data. I
may also choose this option if I am citing my own data. In either case, I will
provide the MRID or Accession number (s). If I cite another registrant's data, I
205
-------
will submit a completed "Certification With Respect To Data Compensation
Requirements" form.
FOR THE GENERIC DATA FORM ONLY The following three options (Numbers
7, 8, and 9) are responses thatapplv only to the "Requirements Status and
Registrant's Response Form "for generic data
Option 7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
Option 8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-in Notice and I
request a low-volume minor use waiver of the data requirement. I am attaching
a detailed justification to support this waiver request including, among other
things, all information required to support the request. I understand that, unless
modified by the Agency in writing, the data requirement as stated in the Notice
governs.
Option 9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than lowvolume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data requirement. I am attaching a rationale
explaining why I believe the data requirements do not apply. I am also
submitting a copy of rny current labels. (You must also submit a copy of your
Confidential Statement of Formula if not already on file with EPA). I
understand that, unless modified by the Agency in writing, the data requirement
as stated in the Notice governs.
FOR PRODUCT SPECIFIC DATA The following option (number 7) is a response
that applies to the "Requirements Status and Registrant's Response Form" for
product specific data.
Option 7. (Waiver Request) I request a waiver for this study because it is inappropriate
for my product. I am attaching a complete justification for this request,
including technical reasons, data and references to relevant EPA regulations,
guidelines or policies. [Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. I understand that this is my only
opportunity to state the reasons or provide information in support of my
request. If the Agency approves my waiver request, I will not be required to
supply the data pursuant to Section 3(c) (2) (B) of FEFRA. If the Agency denies
my waiver request, I must choose a method of meeting the data requirements of
this Notice by the due date stated by this Notice. In this case, I must, within 30
days-of my receipt of the Agency's written decision, submit a revised
"Requirements Status" form specifying the option chosen. I also understand
that the deadline for submission of data as specified by the original Data
Call-in notice will not change.
206
-------
Item 10.
Item 11.
Item 12.
ON BOTH FORMSrThis item must be signed by an authorized representative
of your company. The person signing must include his/her title, and must initial
and date all other pages of this form.
ON BOTH FORMS: Enter the date of signature.
ON BOTH FORMSrEnter the name of the person EPA should contact with
questions regarding your response.
Item 13. ON BOTH FORMS: Enter the phone number of your company contact.
NOTE; You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example you
may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this '
207
-------
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EPA'S BATCHING OF PENDIMETHALIN PRODUCTS FOR MEETING
REREGISTRATION ACUTE TOXICITY DATA REQUIREMENTS
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregi strati on of products containing pendimethalin as the
active ingredient, the Agency has batched products which can be considered similar for
purposes 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. Not with-standing 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 registrant's 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
208
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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 preclude other registrants in the batch from
citing his/her studies and offering to cost share (Option 3) those studies.
56 products were found which contain pendimethalin as an active ingredient. The
products have been placed into six batches and a "no batch" category in accordance with the
active and inert ingredients, type of formulation and current labeling. Table 1 identifies the
products in each batch. Table 2 lists the products which have been placed in the "no batch"
category. PRS advises the registrants to carefully review the following tables for accuracy.
They may propose an alternative method of supporting their products (such as bridging data
from another batch) which we will take into consideration.
TABLE 1
Batch
1
EPA Reg. No.
241-245
241-291
% active ingredient
90.00
86.00
Formulation
Type
liquid
liquid
Batch
2
EPA Reg. No.
241-243
241-305
% active ingredient
42.3
42.3
Formulation
Type
liquid
liquid
209
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Batch
BATCH
3
EPA Reg. No.
241-341
241-360
241-337
AZ92000700
ED93001200
ID96000700
MT93000300
NV92000400
OR93000100
UT92000400
WA92001500
WA92003400
WA96001900
WY92000500
OR93000200
% active
ingredient
37.4
37.4 .
37.4
37.4
37.4
37.4
37.4
37.4
37.4
37.4
37.4 *
37.4
37.4
37.4
37-4
Formulation
Type
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
Batch
4
EPA Reg. No.
241-340
241-338
241-268
% active
ingredient
60
60
60
Formulation
Type
solid
solid
solid
Batch
5
EPA Reg. No.
10404-52
10404-74
% active
ingredient
60
60
Formulation
Type
solid
solid
210
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Batch
6
EPA Reg. No.
341-370
538-172
538-189
538-190
538-196
538-202
538-206
538-207
538-213
538-214
538-219
. 538-226
538-227
538-237
8378-45
10404-82
538-188
538-192
538-193
241-375
% of active
ingredient
0.66
1.00
1.03
0.90
1.15
1.79
4.14
1.79
0.50
1.79
1.79
0.81
4.13
1.79
1.79
0.86
2.68
1.71
1.71 .
2.00
Formulation
Type
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
The following table lists products that were either considered not to be similar or the
Agency lacked sufficient information for decision making and were not placed in any batch.
The registrants of these products are responsible for meeting the acute toxicity data
requirements separately.
211
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TABLE 2
No Batch
NO
BATCH
NO
BATCH
EPA Reg. No.
241-281
538-195
241-373
241-244
241-315
241-331
241-327
241-376
241-297
5905-495
538-251
% active
ingredient
60.00
60.00
50.00
34.40
30.39
30.24
21.96
25.40
25.00
11.25
0.25
Formulation
Type
liquid
solid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
solid
The technicals are listed in batch 1 and the acute toxicology data base, according to the
HED chapter of the pendimethalin RED, is adequate and will support their reregi strati on
eligibility.
NOTE: PRS advises that acute toxicology data from Batch 1 may be bridged to support
product 241-281.
Note for PM only: Batch 6 mainly consists of fertilizer products containing a small
percentage of active ingredient. PRS is working to develop a policy that would allow for the
labeling of fertilizer products, like those listed in batch 6. without acute toxicity testing. As a
result of adopting this policy, DCIs for these products should not be necessary. The PM
should be aware that the policy has not yet been finalized. PRS advises that the PM check
with PRS prior to sending out DCIs for these batch 6 products.
Note for PM only:For product 241-284, PRS was not able to locate a case file jacket for
this product and a CSF was not identified. Therefore, we were not able to make a batching
recommendation for this product.
212
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The following Information is for the PM only:
PRS has acute toxicology data on the following products:
241-243 Prowl Herbicidewas placed in "Batch 1." An acceptable dermal sensitization
study was identified. Acute oral, dermal, inhalation, eye, dermal irritation studies were not
located.
241-373 Squadron DGwas placed in the "No Batch" category. Acceptable acute oral,
dermal, inhalation, eye irritation, dermal irritation and dermal sensitization studies were'
located by PRS.
241-268 Pentagon DG Herbicidewas placed in "Batch 3." PRS located an eye irritation
study that was acceptable. It appears that acute inhalation and sensitization studies were
previously requested by the Agency, but that these studies were never received. In all, it
appears that the acute oral, acute dermal, acute inhalation, dermal irritation and dermal
sensitization studies have not been reviewed by PRS.
241-281 Prowl MC-60 was placed in the "No Batch" category. Acute oral, acute dermal,
eye irritation, and dermal irritation studies were located by PRS and found to be acceptable!
The acute inhalation study was deemed unacceptable. A dermal sensitization study was not
located by PRS.
241-297 Squadron Herbicidewas placed in the "No Batch" category. The acute inhalation
study was acceptable and may be upgraded from Category III to Category IV. The dermal
sensitization study shows that the test material is not a dermal sensitizer. The other required
acute toxicology studies were not located by PRS.
241-315 Pursuit Plus Herbicidewas placed in the "No Batch" category. The acute oral,
acute dermal, eye irritation and dermal irritation studies are acceptable'. PRS needs to review
acute inhalation and dermal sensitization studies for this product.
241-327 Squadron Herbicidewas placed in the "No Batch" category. The acute oral, acute
dermal, acute inhalation, eye irritation, dermal irritation and dermal sensitization studies are
acceptable.
241-331 Pursuit Plus EC Herbicidewas placed in the "No Batch" category. The acute oral,
acute dermal, acute inhalation, eye irritation and dermal irritation studies are acceptable. The'
product is not a dermal sensitizer.
538-251 Fertilizer With Weed Controlwas placed in the "No Batch" category. The acute
oral, acute dermal, acute inhalation, eye irritation and dermal irritation studies are acceptable.
The product is a nonsensitizer.
213
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241-376 Steel Herbicide The acute oral, acute dermal, eye irritation, acute inhalation and
dermal irritation studies are acceptable. The product is not a dermal sensitizer; a data waiver
was granted in 1996.
The following Information is for the PM only:
PRS lacks data from the following batches and no batch products:
Batch 2: Acute oral, acute dermal, acute inhalation, acute eye irritation and dermal irritation
studies from batch 2 product(s) should be submitted.
Batch 3: Acute oral, acute dermal, acute inhalation, acute eye irritation, dermal irritation
studies from batch 3 product(s) should be submitted.
Batch 4: Acute oral, acute dermal, acute inhalation, dermal irritation and dermal sensitization
studies from batch 4 product(s) should be submitted.
Batch 5: Acute oral, acute dermal, eye irritation, acute inhalation, dermal irritation and
dermal sensitization studies from batch 5 product(s) should be submitted.
241-244: Acute oral, acute dermal, acute inhalation, eye irritation, dermal irritation and
sensitization studies should be submitted.
241-281: Acute inhalation and dermal sensitization studies should be submitted.
241-297: Acute oral, acute dermal, eye irritation and dermal irritation studies should be
submitted.
241-315: PRS should review acute inhalation and dermal sensitization studies for this
product.
241-327: Acute oral, acute dermal, acute inhalation, eye irritation, dermal irritation and
sensitization studies should be submitted.
538-195: Acute oral, acute dermal, acute inhalation, eye irritation, dermal irritation and
dermal sensitization studies should be submitted.
5905-495: Acute oral, acute dermal, acute inhalation, eye irritation, dermal irritation and
dermal sensitization studies should be submitted.
214
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible,
signed copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product specific data submission must also
be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds
per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered
source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported
under column 10 and must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds^ kilograms, or grams. In
no case will volumes be accepted. Do not mix English and metric system units (i.e.,
pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure
active form.
m. The upper and lower certified limits for all 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.
217
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United States Environmental Protection Agency
Washington, D.C. 20460
Certification of Offer to Cost
Share in the Development of Data
Form Approved
OMB No. 2070-0106,
2070-0057
Approval Expires
3-31-99
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-233, 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
Company Number
Product Name
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
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 firms on the following
date(s):
Nama of Firm(s)
Data of Offar
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'* Authorizad Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA form 8580 which is obselete
221
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-99
Company Name
Product Name
Company Number
EPA Reg. No.
Public reporting burden for this collection^ 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 orany other aspect of this collection of information
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, 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. J
Please fill in blanks below.
I Certify that:
1. For each study cited in support of registration or reregistratiion 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 oriqinal
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration 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 )(F) 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)
[ ] 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(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
!
I Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1 )(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
223
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APPENDIX E - LIST OF AVAILABLE RELATED DOCUMENTS
The following is a list of available documents for PENDIMETHALIN that my further
assist you in responding to this Reregistration Eligibility Decision document. These
documents may be obtained by the following methods:
Electronic
File format:
2.
Portable Document Format (.PDF) Requires Adobeฎ Acrobat or compatible
reader. Electronic copies can be downloaded from the Pesticide Special
Review and Reregistration Information System at 703-308-7224. They also are
available on the Internet on EPA's gopher server, GOPHER.EPA.GOV, or
using ftp on FTP.EPA.GOV, or using WWW (World Wide Web) on
WWW.EPA.GOV., or contact Jane Mitchell at (703)-308-8061.
Appendix A.
PR Notice 86-5.
3. PR Notice 91-2 (pertains to the Label Ingredient Statement).
4. A full copy of this RED document
5. A copy of the fact sheet for Pendimethalin.
The following documents are part of the Administrative Record for PENDIMETHALIN
and may included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person
listed on the Chemical Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
225
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