&EPA
United States
Environmental Protection
Agency
Office of Prevention, Pesticides EPA 738-R-95-040
And Toxic Substances April 1996
(7508W)
Reregistration
Eligibility Decision (REP)
Trifluralin
Recycled/Recyclable
Printed with Soy/Canola Ink on paper that
contains at least 50% recycled fiber
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
CERTIFIED MAIL
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
APR 30 1996
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 0179 which
includes the active ingredient trifluralin. The enclosed Reregistration Eligibility Decision
(RED) contains the Agency's evaluation of the data base of this chemical, its conclusions of
the potential human health and environmental risks of the current product uses, and its
decisions and conditions under which these uses and products will be eligible for
reregistration. The RED includes the data and labeling requirements for products for
reregistration. It 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 date 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 and Reregistration Division representative
Moana Appleyard (703) 308-8175. Address any questions on required generic data to the
Special Review and Reregistration Division representative Connie Childress at (703) 308-
8076.
Sincerely yours,
Q •
Lois A. Rossi, Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION
1. DATA CALL-IN (PCD 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, another DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific letter will be
enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REOTJESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You
must submit the following items for each product within eight months of the date of this
letter (RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as
formulation changes, or labeling changes not related to reregistration) separately. You may
delete uses which the RED says are ineligible for reregistration. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on
Applying for Registration in the U.S., Second Edition, August 1992" (available from the
National Technical Information Service, publication #PB92-221811; telephone number 703-
487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRXD) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
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batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete
and sign EPA form 8570-31 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the.content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FORREREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St, S.W.
Washington, D.C. 20460-0001
By express;
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS-EPA will screen all submissions for completeness; those which are
not complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregi strati on determination within 14 months after the RED
has been issued.
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United States
Environmental Protection
Agency __^_
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-035
April 1996
.E.D. FACTS
Trif lu rail n
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. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA 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 0179, trifluralin.
Trifluralin is a preemergent herbicide used to control annual grasses
and broadleaf weeds on a variety of food crops and is also currently
registered for non-food uses, including residential use sites. The herbicide
is formulated as a liquid, emulsifiable concentrate, granular, flowable
concentrate, impregnated material, soluble concentrate/liquid, soluble
concentrate/solid, and water dispersible granules (dry flowable). Trifluralin
is typically applied at the dormant, semi-dormant, preplant, pre-transplant,
postplant, preemergence, postemergence, layby, or postharvest stage as a
soil-incorporated treatment. It can be applied by aerial equipment, tractor-
drawn groundbooms, tractor-drawn granular spreaders, push-type
spreaders, "whirly-bird" spreaders, and commercial granular turf spreaders.
Trifluralin was first registered in the United States in 1963 as a
selective preemergent herbicide. A Registration Standard for trifluralin was
issued in April 1987 (NTIS# PB87-201935) and a Data Call-in (DCI) for
reentry protection data and mixer/1 oader/applicator exposure monitoring
data for trifluralin products used on turf was issued in March 1995.
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Human Health
Assessment
EPA initiated a Special Review of trifluralin in August, 1979 because
it was found to contain N-nitroso-di-n-propylamine (NDPA or nitrosamine)
at levels that met or exceeded the Agency's oncogenic risk criterion. In
concluding the Special Review in 1982, EPA required registrants to achieve
a 0.5 ppm upper limit for nitrosamines in their technical products. As part
of the reregistration eligibility decision on trifluralin, the Agency is
requiring that all technical and manufacturing-use registrants submit
nitrosamine analysis data to confirm that levels remain at or below the 0.5
ppm limit.
Toxicity
Trifluralin technical is classified under Toxicity Category IV
(practically non-toxic) for acute oral toxicity and dermal irritation, and
Toxicity Category HI (slightly toxic) for acute dermal toxicity, acute
inhalation toxicity and eye irritation potential. Trifluralin is also classified
as a dermal sensitizer.
Trifluralin has been classified as a Group C, possible human
carcinogen by the OPP Carcinogenicity Peer Review Committee on April 4,
1986. Limited evidence of carcinogenicity exists in male and female rats
based on an increase in combined malignant and benign urinary bladder
tumors in females, renal pelvis carcinomas in male rats, and thyroid gland
follicular cell tumors in males.
Dietary Exposure
People may be exposed to residues of trifluralin through the diet.
Tolerances or maximum residue limits have been established for residues of
trifluralin in many food and feed crops (40 CFR 180.207). EPA has
reassessed the trifluralin tolerances and found that some are acceptable,
while others must be revoked because of refinements in established crop
group tolerances and where no registered uses exist. Tolerances that are
revoked because of refinements in crop groups must be replaced with new
tolerances for the new crop groupings. The tolerance for residues of
trifluralin in/on wheat straw, barley straw, arid barley hay should be
increased to 0.1 ppm.
Processing studies show that residues of trifluralin concentrate in
peppermint oil and spearmint oil. New processing data are required on a
confirmatory basis for both peppermint and spearmint oils to determine the
actual amount of trifluralin that concentrates in both commodities.
Available processing data are sufficient, however, to determine that
trifluralin residues in ready-to-eat foods prepared from the mint oils will not
exceed existing raw agricultural commodity tolerances. Therefore, the
existing tolerance is sufficient to cover the residue levels of trifluralin in
food containing mint oil, and a food additive regulation under Section 409
of the Federal Food, Drug, and Cosmetic Act is not necessary.
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Environmental
Assessment
EPA has assessed the dietary risk posed by trifluralin. The
Anticipated Residue Concentration (ARC) for the overall U.S. population
represents 1% of the Reference Dose (RfD), or amount believed not to
cause adverse effects if consumed daily over a 70-year lifetime. The most
highly exposed subgroup, non-nursing infants less than one year old, has an
ARC which represents 2% of the RfD. This low fraction of the allowable
RfD is considered to be an acceptable dietary exposure risk.
Occupational and Residential Exposure
Based on current use patterns, handlers (mixers, loaders, and
applicators) may be exposed to trifluralin during and after applications in
agricultural and other use sites. The occupational/residential cancer
exposure risk assessment for all uses indicates a level of risk that does not
exceed 10"5 for occupational handlers or 10"7 for residential handlers, levels
considered reasonable by the Agency.
Human Risk Assessment
Trifluralin generally is of low acute toxicity, but has been classified as
a Group C, possible human carcinogen. Many food crop uses are
registered, however, dietary exposure to trifluralin residues in food is at a
low level, as is the cancer risk posed to the general population.
Of greater concern is the carcinogen!city risk posed to trifluralin
handlers, particularly mixers/loaders/applicators, and field workers who
come into contact with treated areas. Exposure and risk to workers will be
mitigated by the use of Personal Protective Equipment required by the
Worker Protection Standard, including coveralls, chemical-resistant gloves,
shoes, and socks. Post-application reentry workers will be required to
observe a 12-hour Restricted Entry Interval.
Environmental Fate
Trifluralin is moderately persistent and non-mobile in a microbially
active soil environment. In general, high persistence and high mobility
promote movement into ground water. Because annual average surface
water concentrations are not likely to exceed the lifetime health advisory
level (2 ug/L) and peak/short term averages are not likely to exceed 1 day
and 10 day health advisory levels, exposure/risk from trifluralin in drinking
water is expected to be minimal. Although trifluralin has no direct aquatic
applications, contamination of surface water may occur by spray drift and
under some circumstances, runoff.
Ecological Effects
Trifluralin is practically non-toxic to birds and mammals on an acute
basis. It does not pose acute risks of concern to terrestrial vertebrates,
except to those which are endangered species. Also, two of four laboratory
bird studies indicate chronic risk, as evidenced by egg shell cracking.
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Additional Data
Required
Product Labeling
Changes
Required
Regulatory
Conclusion
For aquatic animals (fish and invertebrates), trifluralin is considered
moderately to highly toxic, and poses acute toxicity risks of concern to
endangered species. In addition, laboratory and field studies suggest
exposure-related abnormalities in vertebral development, at concentrations
below those where acute effects are anticipated. Also, this assessment is
based on trifluralin dissolved in the water column and does not take into
account trifluralin adsorbed to sediment. Trifluralin adsorbed to sediment
may pose a risk for fish species that forage by feeding from sediment,
particularly since it has a moderate tendency to bioaccumulate. EPA will
explore the need for further monitoring efforts or additional analyses with
the registrants of technical trifluralin in order to obtain more refined
characterization of the risk to fish.
While semi-aquatic plants exceed the "high risk" level of concern,
EPA does not note concerns for effects on aquatic plants resulting from use
of trifluralin. To control adverse effects resulting from aerial application of
trifluralin, the Agency will require a spray drift advisory as precautionary
labeling.
EPA is requiring the following additional generic studies for
trifluralin to confirm its regulatory assessments and conclusions:
nitrosamine analysis data and peppermint oil and spearmint oil processing
data. Residue chemistry data are also required for nongrass
forage/fodder/straw/hay and dill uses because the Agency does not have
enough information at this time to make an eligibility decision for trifluralin
products labeled for those uses. -
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 trifluralin end-use products must comply with EPA's pesticide
product labeling requirements. A 12-hour restricted-entry interval (REI) is
required for uses within the scope of the WPS on all trifluralin end-use
products. Early-entry personal protective equipment (PPE) required for
occupational uses within the scope of the WPS include coveralls, chemical-
resistant gloves and socks plus shoes. Aquatic impact labeling is required
for all trifluralin end-use products. For all trifluralin products that can be
applied aerially, special spray drift prevention language is required.
The use of currently registered products containing trifluralin in
accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. EPA has determined that
products containing trifluralin are eligible for reregistration except products
labeled for use on nongrass forage/fodder/straw/hay and dill. EPA does
not have enough information at this time to make an eligibility decision for
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For More
Information
trifluralin products labeled for those uses. The Agency is requiring
additional data in order to develop a more complete data base regarding
these uses of trifluralin.
Before reregistering any trifluralin product, the Agency will review
product specific data, Confidential Statements of Formula and revised
labeling imposed by the RED. Once this information is accepted, the
Agency will reregister trifluralin products bearing only eligible uses. After
the Agency receives the data necessary to make a reregistration eligibility
decision on nongrass forage/fodder/straw/hay and dill and the data show
that these uses will not cause unreasonable adverse effects, the Agency will
reregister products bearing these uses. Products which contain active
ingredients in addition to trifluralin will be reregistered when all of their
other active ingredients also are eligible for reregistration.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for trifluralin 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 on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp onFTP.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 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the trifluralin 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 trifluralin RED, or reregistration of individual products containing
trifluralin, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
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REREGISTRATION ELIGIBILITY DECISION
TRIFLURALIN
LIST A
CASE 0179
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
TRIFLURALIN REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
H. CASE OVERVIEW , 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 7
D. Data Requirements 11
E. Regulatory History 11
III. SCIENCE ASSESSMENT 12
A. Physical Chemistry Assessment 12
1. Description of Chemical 12
2. Identification of Active Ingredient 12
3. Manufacturing-Use Products 13
B. Human Health Assessment 13
1. Toxicology Assessment 13
a, Acute Toxicity 13
b. Subchronic Toxicity 14
c., Chronic Toxicity and Carcinogenicity 14
d. Developmental Toxicity 16
e. Reproductive Toxicity 17
f. Mutagenicity 17
g. Metabolism 17
h. Dermal Penetration 18
i. Other Toxicity Endpoints 18
2. Exposure Assessment . 18
a. Dietary 18
b. Occupational and Residential 23
3. Risk Assessment 24
a,, Dietary 24
b. Occupational and Residential 25
C. Environmental Assessment 30
1. Ecological Toxicity Data 30
a,, Toxicity to Terrestrial Animals 30
b. Toxicity to Aquatic Animals 32
c. Toxicity to Plants 37
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2. Environmental Fate 39
a. Environmental Fate Assessment 39
b. Environmental Fate and Transport 40
c. Water Resources 48
3. Exposure and Risk Characterization 54
IV. RISK MANAGEMENT AND REREGISTRATION DECISION . . 62
A. Determination of Eligibility 62
1. Eligibility Decision ... 63
2. Eligible and Ineligible Uses 63
B. Regulatory Position 64
1. Tolerance Reassessment 64
2. Codex Harmonization 70
3. Restricted Use Classification 70
4. Reference Dose (RfD) 71
5. Cancer Classification 71
6. Water Resources - Implications for Human Health Risk 71
7. Endangered Species Statement 72
8. Aquatic Impact Labeling 73
9. Occupational/Residential Labeling Rationale/Risk Mitigation ... 73
10. Other Regulatory Restrictions 77
V. ACTIONS REQUIRED OF REGISTRANTS 78
A. Manufacturing-Use Products 78
1. Additional Generic Data Requirements 78
2. Labeling Requirements for Manufacturing-Use Products 79
B. End-Use Products 79
1. Additional Product-Specific Data Requirements 79
2. Labeling Requirements for End-Use Products 80
3. Other Regulatory Requirements 88
C. Existing Stocks 88
VI. APPENDICES 89
APPENDIX A. Table of Use Patterns Subject to Reregistration 91
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 93
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of trifluralin 129
APPENDIX D. Combined Generic and Product Specific Data Call-in ... 167
Attachment 1. Chemical Status Sheets 187
Attachment 2. Combined Generic and Product Specific Data Call-In
Response Forms (Form A inserts) Plus Instructions
189
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Attachment 3.
Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions . . . . 193
EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 201
List of Available Related Documents 211
1. List of AH Registrants Sent This Data Call-In (insert)
Notice ...213
Attachment 2. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions .... 215
Attachment 4.
APPENDIX E.
Attachment
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TRIFLURALIN REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Neil Anderson
Arthur Grube
Richard Peacock
Environmental Fate and Effects Division
David Farrar
Renee Costello
Gail Maske
Health Effects Division
Mary Clock
Jennifer Wintersteen
Whang Phang
Bonnie Cropp-Kohlligian
Bruce Kitchens
Registration Division
Joanne Miller
Daniel C. Kenny
Biological Analysis Branch
Economic Analysis Branch
LUIS
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Risk Characterization and Analysis Branch
Science Analysis Branch
Toxicology Branch II
Reregistration Support Chemistry Branch
Occupational and Residential Exposure Branch
Fungicide-Herbicide Branch
Fungicide-Herbicide Branch
Special Review and Reregistration Division
Judith Coombs
Andrew Ertman
Connie Childress
Walter Waldrop
Carol Stangel
Office of Enforcement and Compliance:
Rick Colbert
Reregistration Branch
Reregistration Branch
Reregistration Branch
Reregistration Branch
Policy, Planning and Operations 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
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic 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
NOEC No effect concentration
NPDES National Pollutant Discharge Elimination System
Xll
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q", The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
This Reregistration Eligibility Decision (RED) document addresses the reregistration
eligibility of the pesticide trifluralin, a,a,a-trifluoro-2,6-dinitro-N,N-dipropyl-p-toluidine.
Trifluralin was first registered in the United States in 1963 for use as a selective preemergent
herbicide. A Registration Standard for trifluralin was issued in April, 1987 (NTIS# PB87-
201935) and a Data Call-In (DCI) for products used on turf was issued in March, 1995.
Trifluralin is a pre-emergent herbicide used to control annual grasses and broadleaf
weeds on a variety of food crops and is also currently registered for non-food uses, including
residential use sites. The herbicide is formulated as a liquid, emulsifiable concentrate,
granular, fiowable concentrate, impregnated material, soluble concentrate/liquid, soluble
concentrate/solid, and water dispersible granules (dry fiowable). Trifluralin is typically
applied dormant, semi-dormant, preplant, pre-transplant, postplant, preemergence,
postemergence, layby, or postharvest as a soil incorporated treatment. It can be applied by
aerial equipment, tractor-drawn groundbooms, tractor-drawn granular spreaders, push-type
spreaders," whirly-bird" spreaders, and commercial granular turf spreaders.
Reregistration Eligibility
The Agency has determined that none of the currently registered uses of trifluralin will
cause unreasonable risk to humans or the environment. All uses are eligible for reregistration
with the exception of nongrass forage/fodder/straw/hay and dill. If residue data are not
generated to support these uses, they must be deleted from all labels. Additional generic data
are required for product chemistry, ecological effects, environmental fate, occupational and
residential exposure, and residue chemistry. These data will be considered confirmatory and
are listed in the attached Data Call-In notice and in Section V of this Reregistration Eligibility
Decision (RED) document.
Product and Residue Chemistry
Additional data remain outstanding for all of the trifluralin technical products. A
possible contaminant in the production of trifluralin is N-nitroso-di-n-propylamine, also
known as NDPA or nitrosamine. Nitrosamine is a carcinogen and the Agency has required
that its levels not exceed 0.5 ppm in any technical or manufacturing-use product containing
trifluralin. All current technical registrations reflect the 0.5 ppm level in trifluralin CSFs,
however, further nitrosamine analysis data are being required as part of the DCI included with
this RED.
Tolerances are established for residues of trifluralin in or on numerous agricultural
commodities. Available enforcement methods are adequate for the determination of trifluralin
residues in/on plant commodities. Tolerances for residues of trifluralin in animal
commodities have not been established and are not needed. The residue chemistry data
-------
battery is substantially complete and a tolerance reassessment summary is included in Section
IV of this RED document. Additional confirmatory residue chemistry data are required to
support the reregistratton of trifluralin.
Peppermint and spearmint are the only crops in which trifluralin has been shown to
concentrate in processed foods (mint oils) at levels above the tolerance established for the raw
agricultural commodity (RAC). The Delaney Clause of Section 409 of FFDCA prohibits the
establishment of food additive regulations (tolerances) for processed commodities that contain
substances that have been shown to cause cancer in "man or animals." Trifluralin has been
classified as a "possible" human carcinogen, thus suggesting that the establishment of a
processed food additive regulation (tolerance) for peppermint and spearmint oil be prohibited.
However, the Agency also recognizes that not all processed foods are "ready to eat." In the
case of peppermint and spearmint oils, they are not consumed in their concentrated form, but
rather diluted as additives to other food products.
Available data show that residues of trifluralin in foods prepared with mint oil will not
exceed the existing raw agricultural commodity tolerance. A food additive regulation is
therefore not required and the existing peppermint and spearmint food additive regulations
will be revoked. The Agency will, however, use its general rule-writing authority under the
Federal Food Drug and Cosmetic Act (FFDCA) section 701 to establish Maximum Residue
Limits (MRLs) for peppermint and spearmint oils at 2.0 ppm. In addition, new peppermint
and spearmint processing data are required to determine the factor by which trifluralin
concentrates in these commodities. Establishing an MRL at 2.0 ppm will help ensure that the
levels in food commodities containing mint oil do not exceed the raw agricultural commodity
tolerance of 0.05 ppm.
Toxicology
Trifluralin technical is classified under category IV for acute oral toxicity and dermal
irritation, toxicity category HI for acute dermal toxicity, acute inhalation toxicity and eye
irritation potential, and toxicity category IV for dermal irritation. Trifluralin is also classified
as a dermal sensitizer.
The Reference Dose (RfD) for chronic oral exposure is 0.024 mg/kg/day as
determined from a one-year feeding study in dogs. The NOEL was 2.4 mg/kg/day, using a
safety factor of 100. Trifluralin was classified as a group C, possible human carcinogen by
the OPP Carcinogenicity Peer Review Committee on April 4, 1986. The Qx* for quantitation
of human risk is 0.0077 mg/kg/day'1.
Dietary Risk
Anticipated residue data were developed for trifluralin residues of concern in/on
carrots, wheat, tomatoes and sugarcane crop and processed food commodities for
VI
-------
carcinogenic risk assessment purposes and were used for the Dietary Risk Evaluation System
(DRES) analysis. With all of the DRES population subgroups having Theoretical Maximum
Residue Contribution (TMRC) and Anticipated Residue Contribution (ARC) values well
below the Reference Dose (RfD), the chronic non-carcinogenic dietary risk from exposure to
trifluralin has been determined to be of minimal concern. When using refinements in residues
and percent of crop treated information, the upper bound carcinogenic risk of trifluralin, 1.0 x
10'6 (viz. 0.96 x 10"6) does not exceed the level of concern for excess lifetime dietary cancer
risk.
Occupational and Residential Exposure and Risk
The Agency has identified a potential for exposure to trifluralin for mixers, loaders,
applicators, or other handlers during usual use pattern practices associated with this chemical.
However, the occupational/residential cancer exposure/risk assessment for all uses indicates a
level of risk that does not exceed 10'5 for occupational handlers or 10'7 for residential
handlers.
No data are available to calculate post-application exposures and risks following
trifluralin treatments, however, the dermal absorption value is very low (one percent) and
inhalation exposures are not a concern for post-application scenarios. These factors suggest
that occupational and residential post-application exposures will probably be no higher than
exposures to occupational handlers. Since the occupational/residential cancer exposure/risk
assessment for all uses indicates a level of risk that does not exceed 10'5 for occupational
handlers or 10"7 for residential handlers, the Agency does not anticipate that the exposure/risk
assessment for post-application scenarios would exceed these levels for occupational or
residential exposures.
A Data Call-In was issued in March, 1995 requiring generic turf exposure data. This
DCI was sent to all technical and manufacturing-use registrants of products registered for use
on home lawns or grass, that are applied by homeowners or professionals. Data were called
in for foliar residue dissipation, dermal exposure upon reentry, dermal exposure from
mixing/loading/applying and inhalation exposure from mixing/loading/applying. The data
generated will allow the Agency to more accurately estimate homeowner exposure from
pesticides applied to home lawns and turf.
For occupational end-use products containing trifluralin as an active ingredient, the
Agency believes that the 12-hour restricted-entry interval (RET), currently on the labels with
uses within the scope of the WPS, is appropriate. The PPE required for early entry is the
minimum PPE established under the WPS for early entry: coveralls, chemical-resistant
gloves, shoes, and socks.
vn
-------
Environmental Fate and Risk to Water Resources
Available information on the properties of trifluralin in the environment suggest that it
is moderately persistent and non-mobile in a vital (microbially active) soil environment. In
general, high persistence and high mobility promote movement into ground water. Detections
of trifluralin in ground water have been reported to the Agency, however, the validity and
significance of these detections is questionable on several grounds and the information is not
being considered by the Agency to be a basis for risk reduction measures. Because annual
average surface water concentrations are not likely to exceed the lifetime health advisory level
(2 ug/L) and peak/short term averages are not likely to exceed 1 day and 10 day health
advisory levels, exposure/risk from trifluralin in drinking water is expected to be minimal.
Although trifluralin has no direct aquatic applications, contamination of surface water may
occur by spray drift and under some circumstances, runoff.
Ecological Effects Assessment
Trifluralin ranks as practically non-toxic to birds and mammals on an acute basis,
using a simple hazard classification scheme. Nontarget acute risk quotients (the estimated
environmental concentration divided by the toxicity test effect level) do not suggest a concern
for terrestrial vertebrates in general. However, the more sensitive endangered species risk
quotients are exceeded for terrestrial vertebrates. Also, two of four laboratory bird studies
indicate chronic risk, as evidenced by egg shell cracking.
For aquatic animals (fish and invertebrates), trifluralin ranked as moderate to high
toxicity according to the hazard classification scheme. Risk quotients for acute effects do not
indicate concerns for nonendangered species, but the more sensitive endangered species risk
quotients are exceeded (for freshwater fish, RQ 0.03 to 0.08 versus Level of Concern 0.05).
(Levels of Concern (LOCs) are criteria used to indicate potential risk to nontarget organisms.)
In addition, laboratory and field studies suggest exposure-related abnormalities in vertebral
development, at concentrations below those where acute effects are anticipated. Also, the
LOG determination is based on trifluralin dissolved in the water column and does not take
into account trifluralin adsorbed to sediment. Trifluralin adsorbed to sediment may pose a
risk for fish species that forage by feeding from sediment, particularly since trifluralin has a
moderate tendency to bioaccumulate. The Agency will explore further monitoring efforts or
additional analyses with the registrants of technical trifluralin in order to obtain more refined
characterization of the risk to fish.
For terrestrial and semi-aquatic plants the Agency does find a concern for the semi-
aquatic category: risk quotients were obtained that exceeded the "high risk" level of concern
(RQ 0.7 to 1.3 versus LOG 1). The Agency does not find concerns for effects on aquatic
plants resulting from use of trifluralin. For control of adverse effects caused by spray drift,
the Agency will require precautionary labelling described in section V, which is standard for
pesticides with aerial applications.
Vlll
-------
Before reregistering the products containing trifluralin, 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 and acute toxicity testing for each registered product. After reviewing
these data and any revised labels and finding them acceptable in accordance with Section
3(c)(5) of FIFRA, the Agency will reregister a product. Those products which contain other
active ingredients will be eligible for reregistration only when the other active ingredients are
determined to be eligible for reregistration.
IX
-------
-------
I.
INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration process. The first four phases of the
process focus on identification of data requirements to support the reregistration of an active
ingredient and the generation and submission of data to fulfill the requirements. The fifth phase
is a review by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data
submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that, in Phase 5, "the Administrator shall determine
whether pesticides containing such active ingredients 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.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of trifluralin. The document consists of six sections. Section I is the
introduction. Section II describes trifluralin, its uses, data requirements and regulatory history.
Section ffl discusses the human health and environmental assessment based on the data available
to the Agency. Section IV presents the reregistration decision for trifluralin. Section V discusses
the reregistration requirements for trifluralin. 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.
-------
H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision document:
Common Name:
Chemical Name:
Chemical Family:
Trifluralin
a,a,a-trifluoro-2,6-dinitro-N,N-dipropyl-p-toluidine
Dinitroaniline
CAS Registry Number: 1582-09-8
OPP Chemical Code: 036101
Empirical Formula: C13H16F3N3O4
Trade and Other Names: Treflan, L-36352, Crisalin, Su Seguro Carpidor,
Trefanocide, Treficon, TR-10, Triflurex, Trim,
Ipersan, Sinflouran, Ipifluor
Basic Manufacturers:
DowElanco, Makhteshim-Agan, Industria Prodotti
Chimici S.P.A (I.Pi.Ci.), Tri Corporation, Albaugh
Inc.
B. Use Profile
The following is information on the current registered trifluralin uses with an
overview of use sites and application methods. A detailed table of these uses can be
found in Appendix A, which is available upon request.
Multiple active ingredient products contain;
078802 - triallate
084301 -benfiuralin
090501 - alachlor
101101 -metribuzin
105501 -tebuthiuron
125401 - clomazone
125851 -isoxaben
128848 - imazaquin
-------
128982 - imazethapyr
129016 - flumetsulam
059101 - chlorpyrifos
032501 - disulfoton
Mode of Action;
Trifluralin is a dinitroaniline herbicide that enters plants through developing
roots and stops plant cells from dividing and elongating (meristematic inhibitor).
Type of Pesticide for Single Active Ingredient:
Herbicide
Additional Type of Pesticide for Multiple Active Ingredient:
Acaricide; Insecticide
Use Sites;
TERRESTRIAL FOOD CROPS (Note:
* Apricot
* • Asparagus
* Broccoli
* Brussels Sprouts
* Cabbage
* Cabbage, Chinese
* Carrot (including tops)
* Prune
* Cauliflower
* Celery
* Chicory
* Walnut (english/black)
* Crambe
* Cucumber
Dill is ineligible for reregistration)
* Cucurbit Vegetables
* Bifr (ineligible)
Eggplant
* Endive (escarole)
* Kale
* Kohlrabi
* Lentils
* Melons, Cantaloupe
* Melons, Water
* Mustard
* Nectarine
* Collards
* Onions (green)
* Onions (scallions)
TERRESTRIAL FOOD AND FEED CROPS
* Almond
* Barley
* Beans
* Beans, Dried-type
* Bean, Mung
* Beans, Succulent (lima, snap)
* Lemon
* Lupine
* Mint
* Mint (Pepper and Spear)
* Mustard
* Orange
* Onions(spring)
* Peach
* Pecan
* Pepper
* Pepper (chili type)
* Plum
* Lettuce
* Radish
* Stone Fruits
* Turnip
* Okra
* Sugar Beet
* Sugarcane
* Sunflower
* Tangelo
* Tangerines
* Tomato
-------
* Citrus Fruits
* Cole Crops
* Corn (field)
* Cotton
* Cowpea/Blackeyed Pea
* Flax
* Grapefruit
* Grapes
* Guar
* Hops
TERRESTRIAL FEED CROPS (Note:
for reregistration)
* Alfalfa
* Barley
* Bermudagrass
* Clover
* Corn
* Cotton
* Wheat
* Peanuts
* Peas, Dried-type
* Peas, Field
* Peas, Southern
* Peas, Succulent
* Potato, White/Irish
* Rape
* Safflower
* Sorghum
* Soybeans
* Tree Nuts
* Turnip
* Wheat
Nongrass: Forage/Fodder/Straw/Hay are ineligible
•k TJ-.no race
l*NUll££lClOk>
Fui dge./Foddci/G traw/IIay (ineligible)
* Peanuts
* Rape
* Soybeans
* Sugar Beets (incl. tops)
TERRESTRIAL NON-FOOD CROPS
* Agricultural
Rights-Of-Way/Fencerows/
Hedgerows
* Airports/Landing Fields
* Almond (non-bearing)
* Apple (non-bearing)
* Apricot (non-bearing)
* Avocado (non-bearing)
* Blackberry (non-bearing)
* Blueberry (non-bearing)
* Boysenberry (non-bearing)
* Cables/Cable Coverings *
* Nonagricultural Rights-Of-Way/
Fencerows/Hedgerows
* Cherry (non-bearing) *
* Nonagric. Uncultivated Areas/Soils
* Citrus Fruits (non-bearing) *
* Commercial/Industrial Lawns *
* Currant (non-bearing) *
* Dewberry (non-bearing) *
* Elderberry (non-bearing) *
Grapes (non-bearing)
Industrial Areas (outdoor)
Kenaf
Kiwi Fruit (non-bearing)
Lemon (non-bearing)
Lesquerella
Loganberry (non-bearing)
MacadamiaNut (bushnut; non-bearing)
Nectarine (non-bearing)
Nonagric. Outdoor Buildings/Structures
Castor Bean
Christmas Tree Plantations
Olive (non-bearing)
Orange (non-bearing)
Ornamental and/or Shade Trees
Ornamental Ground Cover
Ornamental Herbaceous Plants
-------
* Fig (non-bearing)
* Filbert (hazelnut; non-bearing)
* Golf Course Turf
* Gooseberry (non-bearing)
* Grapefruit (non-bearing)
* Pistachio (non-bearing)
* Plum (non-bearing)
* Pomegranate (non-bearing)
* Prune (non-bearing)
* Raspberry (black, red;
non-bearing)
Recreation Area Lawns
Recreational Areas
*
* Ornamental Woody Shrubs and Vines
* Paved Areas (private roads/sidewalks)
* Peach (non-bearing)
* Pear (non-bearing)
* Pecan (non-bearing)
*
Refuse/Solid Waste Sites (outdoor)
Sewage Disposal Areas
* Stone Fruits (non-bearing)
* Tangelo (non-bearing)
* Tangerines (non-bearing)
* Tree Nuts (non-bearing)
* Walnut (english/black; non-bearing)
TERRESTRIAL NON-FOOD AND OUTDOOR RESIDENTIAL
* Nonagricultural
Rights-Of-Way/Fencerows/Hedgerows
* Ornamental and/or Shade Trees
* Ornamental Ground Cover
* Ornamental Herbaceous Plants
* Ornamental Lawns and Turf
* Ornamental Nonflowering Plants
* Ornamental Woody Shrubs and Vines
* Paths/Patios
* Paved Areas (private roads/sidewalks)
* Swimming Pools (impregnated nodules on fabric placed in soil to protect pools
from root encroachment; an in-soil barrier plane)
FORESTRY
* Cottonwood (forest/shelterbelt)
* Poplar (forest/shelterbelt)
OUTDOOR RESIDENTIAL
* Ornamental and/or Shade Trees
* Ornamental Ground Cover
* Ornamental Herbaceous Plants
* Ornamental Woody Shrubs and Vines
* Soil, Preplant/Outdoor
Target Pests for Single Active Ingredient:
annual bluegrass, bottlegrass, bristlegrass, bromegrass, broncograss, burgrass,
carelessweed, carpetweed, cheat, chess, duckweed, Coloradograss, crabgrass,
-------
cupgrass, field morningglory, Florida pusley, German millet, giant foxtail, goathead,
goosefoot, guineagrass, hairy crabgrass, henbit, johnsongrass, jointed goatgrass,
junglerice, knotweed, lambsquarters, lovegrass, Mexican fireweed, nettle, panicum,
pigeongrass, pigweed, pusley, red rice, rough pigweed, Russian thistle, silver
crabgrass, small crabgrass, spiny pigweed, sprangletop, spreading pigweed, stinging
nettle, watergrass, wild barley, wild oat, wiregrass, woolly cupgrass
Types/Formulations Registered:
Technical Grade Active Ingredient
- Product Solid (95.6% - 98%)
Manufacturing Products
- Emulsifiable Concentrate 44.5%
-Liquid 50.8%
End Use Products
- Emulsifiable Concentrate 3.9 to 50.8%
- Flowable Concentrate 10.9%
- Form Not Identified/Liquid 36.3 5 to 50.8%
-Granular 0.17 to 10.0%
- Impregnated Material 18.9%
- Soluble Concentrate/Liquid 43.8%
- Soluble Concentrate/Solid 14.0%
- Water Dispersible Granules (dry flowable) 0.75 to 80.0%
Methods and Rates of Application:
See Appendix A
Types of Treatment;
Barrier treatment; Broadcast; Chemigation; Containerized plant treatment; Golf course
treatment; Ground spray; Prepaving treatment; Soil broadcast treatment; Soil
incorporated treatment; Soil treatment; Spray
Equipment;
Aircraft; Boom sprayer; By hand; Center pivot irrigation; Drip irrigation; Fixed-wing
aircraft;'Glove; Granule applicator; Ground; Hand held sprayer; Hand held; Hand
move irrigation; Helicopter; Low pressure ground sprayer; Not on label; Overhead
sprinkler irrigation; Pneumatic (compressed air) applicator; Shaker can; Solid set
irrigation; Sprayer; Spreader; Sprinkler can; Sprinkler irrigation; Wrap
Timing;
April; At planting; August; Bearing; Containerized; Dormant; Early fall; Early
preplant; Early spring; Early summer; Established plantings; Fall; Foliar; July; June;
Late spring; Late summer; Late winter; Layby; May; Nonbearing; Not on label; Plant
bed; Postemergence; Postharvest; Postplant; Posttransplant; Preemergence; Preharvest;
-------
Preplant (Fall); Preplant (Spring); Preplant; Pretransplant; Seed piece; Seed; Seedling
stage; Semi-dormant; September; Spring; Summer; Transplant; When needed; Winter
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
trifluralin. 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.
Trifluralin is an herbicide used on a wide range of foods crops. It is also
registered for some non-food crop uses. Of the approximately 25,000,000 pounds of
active ingredient, annually used on agricultural crops, 64% is used on soybeans with
another 19% used on cotton. The remaining 17% is used on a wide range of crops.
Crops with more than 50% of the planted acres receiving an application of trifluralin
include green beans, broccoli, tomatoes, and cotton. Other crops with more than 20%
of the planted acres treated with trifluralin include collards, cabbage, sunflowers, dry
beans, cauliflower, okra, soybeans, carrots, flax, Brussels sprouts, asparagus, and
sweet peppers.
For non-food crops, trees and ornamentals appear to be the most significant
sites with approximately 150,000 pounds of active ingredient used annually. Little use
of trifluralin on turf was reported.
The table below summarizes trifluralin's uses by site:
' "• TRlFLC&ALtN USAGE "'"
Crop i
Alfalfa
Almonds
Apricots
Asparagus
Barley
Beans, Dry
Beans, Green
Broccoli
Acres
Planted
<6Dfl*s
flM»r»P«^
24,835
389
19
55
8,190
1,809
319
27
% of ;
Site
Treated
2
2
Likely.
Maximum
% Treated
4
4
total %
Active
Ingredient
(flflft's 1*»cf
778
7
tikeiy ;
Maximum \
{908*8 fc> :
1,425
14
Acre*
Treated
$0#s "
•iri'i>«)
584
9
lakety
Maximum
(OflO's
a^ffli)
1,030
14
Limited individual crop data. Very little usage reported on stone fruits as a group.
22
5
37
85
32
57
7
52
93
26
14
192
417
158
14
38
309
558
179
17
12
410
676
271
19
31
531
937
298
23
-------
"*'„ '', ' ' >
Crop
Brussels Sprouts
Cabbage
Canola
Carrots
Cauliflower
Celery
Cherries
Clover
Collards
Com
Cotton
Cucumbers
Dill
Eggplant
Endive & Escarole
Flax
Grapefruit
Grapes
Hay. Other
Hops
Kale
Lemons
Lentils
Lettuce
Limes
Lots/farmstcads/ctc.
Lupines
Melons, Cantcloupc
Melons, Honeydew
Wanted
4
84
170
65
44
34
95
f •• f Sf :
*!N
25
35
7
28
55
6
Ufely
Maximum
% treated
30
35
. 14
43
43
12
/rot*!, '
Ingredient
-------
"-'" "" ' ',' ' " "- TRlf LlMALlN tTSAiGE
Cr6p
Mint
Mustard greens
Nectarines
Oats
Okra
Onions
Oranges
Parsley
Pasture/Rangeland
Pasture/Rangeland,
Other
Peaches
Peanuts
Peas, Dry
Peas, Green
Pecans
Peppers, Hot
Peppers, Sweet
Plums & Prunes
Potatoes
Pumpkins
Rape (see also
Canola)
Safflower
Seed Crops
Setaside acres
Sorghum
Soybeans
Squash
Sugar beets
Acres
Planted
«** fowl
146
10
27
4,364
6
149
646
5
VooF
Site
IWfed. ';
<1
Lifeety
,,,Ma£inM;Hit
%f reated
1
fatal
ActiVte
Ingredient
«lflft<<= 1h<:%
<1
likely "":
Maximum
{»«&*» lb>
1
Acnes
Treated
COBfl's -
«M-^ps)
<1
Ukely
Maximum
(Oto's
Qi-ro«V
2
No information available.
Limited individual crop data. Very little usage reported on stone fruits as a group.
<1
33
12
<1
<1
67
12
1
15
1
11
6
24
2
11
14
12
2
17
4
22
4
17
8
No usage observed.
„
2
8
7
38
No usage observed.
179
1,690
166
321
453
34
67
130
1373
41
12
323
..
„
11,611
58,909
58
1,434
<1
11
19
17
1
<2
16
27
19
2
<1
106
20
33
4
<2
135
26
37
9
<1
194
32
56
6
<2
258
45
62
9
No usage observed
22
<1
7
2
39
<2
10
' 5
12
1
58
<1
20
2
100
1
15
1
89
<1
26
2
139
2
No information available.
8
„
_
1
33
7
8
16
-_
_
2
38
14
11
21
4
118
77
17,985
3
73
42
4
204
148
23,305
6
92
25
4
192
119
19,494
4
120
50
4
336
226
22,091
8
153
-------
;,,/"< '"" tl«FLlJRAL|NlfSA.-G-E.' "" ' ' " ' '* ', •
Crop
Sugarcane
Summer fallow
Sunflower
Sweet Corn
Tangclos
Tangerines
Tomatoes
Turnip greens (tops)
Watermelon
Wheat
Agricultural Total
Trees, Ornamentals
&Turf
; j •" S
\ Acres
! Planted.
; ;
n^r^ife)
926
__
2,580
748
_.
„
456
10
239
71,464
„
-
%or- :
Site- - - i
•Xreafedt ;
15
—
44
<1
Lifeely "f ,
' Maximum
% treated.
?•"* *"
20
—
49
1
' fatal
A-cBVfe ..
Ifl'gr'edHJn't'
flfaft<4
248
79
838
1
JLikeJy :
Maximum :
-------
D. Data Requirements
Data requested in the April, 1987 Registration Standard for trifluralin included
studies on product and residue chemistry, toxicology, ecological effects and
environmental fate. These data were required to support the uses listed in the
Registration Standard. A Data Call-In was issued by the Agency in March, 1995 for
reentry protection data and mixer/loader/applicator exposure monitoring data on
trifluralin and other chemicals used on turf. These data are due in 1996 and 1997,
respectively. Appendix B of this RED document includes all data requirements
identified by the Agency for currently registered uses needed to support reregistration.
E. Regulatory History
Trifluralin was first registered in the United States in 1963 for use as a selective
preemergent herbicide. A Registration Standard for trifluralin was issued in April,
1987 (NTIS# PB87-201935). This Reregistration Eligibility Decision reflects a
reassessment of all data submitted in support of trifluralin reregistration.
A Special Review was initiated in August, 1979 because trifluralin products
contained N-nitroso-di-n-propylamine (NDPA or nitrosamine) at levels that met or
exceeded the oncogenic risk criterion. The Agency's Position Document (PD 1/2/3)
proposed cancellation of all trifluralin product registrations unless registrants modified
their labels and Confidential Statements of Formula (CSFs) to reflect an upper limit for
NDPA of 1 ppm.
In 1982, the Agency revised its position on nitrosamine requirements for
trifluralin and issued the Trifluralin PD-4, reducing the allowable nitrosamine level to
0.5 ppm. The Agency also withdrew the requirement that product labels state the level
of NDPA contamination. The PD-4 required registrants to list a 0.5 ppm upper
certified limit for nitrosamines on CSFs for all technical products. For formulated
products, the upper limit for total N-nitrosamine content is to be calculated on a
percentage basis including a multiplication factor of 2 (e.g., for a 25% FI: 0.5 ppm
nitrosamine in TGAI x 0.25% ai x 2 - 0.25 ppm maximum nitrosamine). The
Confidential Statements of Formula (CSFs) for all currently registered trifluralin
technical products list nitrosamine levels at or below the 0.5 ppm level. As specified
in the PD-4, registrants are required to advise the Agency of quality control procedures
and maintain quality control records.
Although the trifluralin technical product CSFs state that nitrosamine levels are
at or below 0.5 ppm, the Agency is requiring that all technical and manufacturing-use
registrants confirm this by submitting nitrosamine analysis data for each of their
technical and/or manufacturing-use products. The issue of nitrosamine levels in
11
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trifluralin end-use products is addressed in the product-specific Data Call-In included
in this RED.
Currently, there are 172 active products containing trifluralin which are
registered under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). They consist of technicals, formulation intermediates, impregnated
materials, granulars, soluble concentrates, emulsifiable concentrates, wettable
powders, dusts, pressurized dusts, and water dispersible granules.
HI. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
1. Description of Chemical
Trifluralin (a,a,a-trifluoro-2,6-dinitro-N,N-dipropyl-p-toluidine) is a
selective preemergence herbicide registered for weed control primarily on
soybeans and cotton, as well as on various vegetable crops.
Empirical Formula: Clfl1f^3O4
Molecular Weight: 335.3
CAS Registry No.: 1582-09-8*
ShaughnessyNo.: 036101
2. Identification of Active Ingredient
Trifluralin is a yellow-orange crystalline solid with a melting point of
42-49° C. Trifluralin is practically insoluble in water (<1 ppm), but is readily
soluble in organic solvents such as acetone, xylene, or aromatic naphthas.
12
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3. Manufacturing-Use Products
The table below summarizes the currently registered manufacturing-use
trifluralin products. At the time of the Trifluralin Reregistration Standard
(4/87), the DowElanco products listed below were registered to Blanco
Products Company. When Blanco merged with Dow Chemical to become
DowElanco, EPA registration numbers for the products were changed.
Formulation
98% T
96% T
96.3% T
95.6% T
96.3% T
50.8% FI
44.5% FI
97.47% T
96.3% T
BFAfteg,M0,
„'„ (Date of Regl^ratLon)
11603-13 (2/73)
19713-384(5/95)
33660-3 (5/76)
42750-30(10/94)
62719-99 (12/89) "
62719-172 (6/90) b
62719-101 (12/89) *
67959-1 (6/94)
68156-3 (9/94)
#, RegisfeFaBl
Agan Chemical Manufacturers, Ltd.
Drexel
IndustriaProdotti Chimici S.P.A (LPi-Ci.)
Albaugh, Inc.
DowElanco
i
Tri Corporation
Dintec Agrichemicals
" Previously registered to Blanco Products Company, EPA Reg No. 1471-70 (4/70).
b Previously registered to Blanco Products Company, EPA Reg No. 1471 -120 (12/81).
0 Previously registered to Elanco Products Company, EPA Reg No. 1471-72 (4/70).
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base for trifluralin is adequate and will support
reregistration eligibility for all trifluralin uses.
a, Acute Toxicity
Acute toxicity values and categories for trifluralin are
summarized in the table below:
13
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Gdln
81-1
81-2
81-3
81-4'
81-5"
81-6'
81-7
: ^ , Test
** •''"'"
Oral LD50 - Rat
Dermal LD50 - Rat
Inhalation LC50 - Rat
Eye Irritation - Rabbit
Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
Acute Delayed Neurotoxicity - Leghorn
Hens
Citation
CMHIB}
00157486
00157482
00155261
00157483
00157485
00157484
00159616
Result!'"/'
>5000 mg/kg
>2000 mg/kg
>4.66 mg/L
slight irritation
no irritation
sensitizer
>5000 mg/kg
Y Y y y • • yfy • •
,f fcat%0*y ,
', , ' '
IV
III
III
III
IV
_
-
* Note: Data pertaining to acute eye irritation, dermal irritation, and dermal sensitization are not required to
support the reregistration of the TGAI. These data are presented for informational purposes.
b. Subchronic Toxicity
90-Day Feeding - Rodent: A subchronic oral toxicity study was
performed in Fischer 344 rats using concentrations of 0.005, 0.02, 0.08,
0.32 or 0.64 % in the diet. The NOEL was 0.005% (50 ppm or 2.5
mg/kg/day). The LOEL was 0.02% (10 mg/kg/day) based on increased
hyaline droplet formation in cortical cells, increased total urinary protein
excretion, and changes in urine color and clarity. Many of the effects
were reversible within a six-week recovery period (MRID 40138301).
A second subchronic oral toxicity study, using Wistar rats and
higher trifluralin doses of 0, 800, 2000, or 5000 ppm, indicated that the
NOEL was less than 800 ppm (40 mg/kg/day, lowest dose tested), due
to reductions in relative liver and pituitary gland weights at all dose
levels tested (MRID 00151906). .
31-Day Dermal Toxicitv - Rodent: A 31-day dermal toxicity study
was performed with trifluralin in Wistar rats using doses of 0, 40, 200 or
1000 mg/kg/day for six hours/day for a total of 23 applications. The
NOEL was 200 mg/kg/day based upon increased liver weight at the
highest dose tested (MRID 00153171).
c. Chronic Toxicity and Carcinogenicity
Chronic Toxicitv - Non-Rodent: Beagle dogs were fed trifluralin by
capsule at doses of 0, 0.75, 2.4 or 40 mg/kg/day for one year. The
14
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NOEL was 2.4 mg/kg/day and the LOEL was 40 mg/kg/day based upon
reduced body weight, decreased red cells and hemoglobin levels,
increased thrombocyte, methemoglobin, cholesterol and triglyceride
levels, and increased liver weight (MRID 42447001).
In a second beagle dog study, doses of 0, 30, 150 or 750 ppm
were fed in the diet for one year. The NOEL was 30 ppm (the lowest
dose tested, 0.75 mg/kg/day). The LOEL was 150 ppm (3.75
mg/kg/day) based upon increases in liver weight and methemoglobin.
At the high dose, there were also decreased weight gain, decreased
RBC, increased methemoglobin, increased serum lipids, triglycerides,
and cholesterol (MRID 00151908, 00159618).
Chronic Toxicitv/Oncogenicitv - Rodent; Several long-term
carcinogenicity studies were conducted with trifluralin in rodents. One
study was performed in Fischer 344 rats using dietary doses of 0, 813,
32,50 or 6500 ppm for two years. The highest dose (325 mg/kg/day)
resulted in significant increases of combined malignant and benign
urinary bladder tumors in females. An increase in the incidence of
carcinomas of the renal pelvis was seen in all dose groups of males. In
addition, an increase in the incidence of thyroid gland follicular cell
tumors (adenomas plus carcinomas combined) in males was found.
(MRID 00044337).
The other rat bioassays were: a two-year study in Sprague
Dawley rats at doses of 0, 200, 1000 or 2000 ppm; a 78-week study in
Osborne-Mendel rats at doses of 0, 3250 or 6500 ppm, conducted by the
National Cancer Institute; and a two-year study in Wistar rats at doses of
0, 200, 800 or 3200 ppm (MRID 00162456, 00162457, 00162458). In
the last study, the systemic LOEL was 800 ppm (40 mg/kg/day) based
on body weight changes.
Oncogenicitv •- Mouse: There were three mouse carcinogenicity
bioassays of trifluralin. A 78-week study was conducted by the
National Cancer Institute with B6C3F! mice at doses of 0, 2375 or 5000
ppm. The test compound was contaminated with N-nitroso-di-n-
propylamine, which was considered to be the cause of the liver
carcinomas, alveolar-bronchiolar adenomas, and squamous-cell
carcinomas of the forestomach in the female mice (Jaeger, 1986).
A two-year study, conducted in B6C3FJ mice at doses of 0, 563,
2250 or 4500 ppm, found no tumors due to the test compound (MRID
00044338).
15
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A two-year study in NMRI mice used purified test compound at
doses of 0, 50, 200 or 800 ppm. There were increased liver weights in
males at 200 or 800 ppm (30 and 120 mg/kg/day) and in females at the
high dose. The systemic NOEL was 50 ppm (7.5 mg/kg/day) in male
mice and 200 ppm in females. No tumors due to the test compound
were found (MRID 00158935, 40392313).
The available mouse carcinogen!city studies showed that
trifluralin did not induce increases in tumor incidence in any of the
mouse studies.
Carcinogenicitv Classification; The OPP Carcinogenicity Peer
Review Committee evaluated all the available carcinogenicity data on
trifluralin (April 4, 1986), and it concluded that there is limited evidence
of carcinogenicity in male and female rats based upon an increase in
combined malignant and benign urinary bladder tumors in females,
renal pelvis carcinomas in male rats, and thyroid gland follicular cell
tumors (adenomas plus carcinomas combined) in males. Trifluralin has
been classified as a Group "C", possible human carcinogen with a Qx*
of 0.0077 mg/kg/day-1.
d. Developmental Toxicity
Teratogenicitv - Rat: Charles River rats were given gavage doses of 0,
100, 225, 475 or 1000 mg/kg/day of trifluralin on gestation days 6-15.
The maternal toxicity NOEL was 225 mg/kg/day due to reduced weight
gain and food consumption at higher dose levels. The developmental
toxicity NOEL was 475 mg/kg due to reduced mean fetal body weight
at 1000 mg/kg/day (MRID 00152419).
Teratogenicitv - Rabbit; Dutch Belted rabbits were given oral doses
of 0, 100, 225 or 500 mg/kg/day of trifluralin on gestation days 6-28.
The maternal toxicity NOEL was 100 mg/kg/day due to anorexia,
cachexia and resulting abortion at higher dose levels. The
developmental toxicity NOEL was 225 mg/kg/day based on depressed
fetal weight and an increased number of fetal runts at higher doses
(MRID 00152421).
No teratogenic effects occurred in rats or rabbits.
16
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e. Reproductive Toxicity
2-Generation Reproduction - Rat; A reproductive NOEL of greater
than or equal to 2000 ppm (i.e. 0.2% in the diet) was established in a
two-generation study in which trifluralin was fed to CD rats at dietary
levels of 0, 200, 630 or 2000 ppm (15, 47, or 148 mg/kg/day). The
systemic NOEL was 200 ppm. The systemic LOEL was 630 ppm due
to reduced body weights in parental animals (MRID 00162543).
Another two-generation study was conducted with Wistar KFM-
Han rats, using doses of 0, 200, 650, or 2000 ppm in the diet. There
were increased relative kidney weights at all dose levels tested, and thus
the parental LOEL was 200 ppm (10 mg/kg/day). The two higher doses
showed renal lesions and increased relative liver weights. The NOEL
for reproductive and developmental toxicity was 200 ppm. The LOEL
was 650 ppm (32.5 mg/kg/day) based on reduced weanling body
weights at 650 and 2000 ppm, and reduced litter sizes at the highest
dose (MRID 00151901, 00151902, 00151903).
f. Mutagenicity
Trifluralin was negative for genotoxicity in the Ames test (MRID
00153173, 00126660) and an assay of mammalian cells in culture to
assess forward mutations at the TK locus of L5178Y mouse lymphoma
"cells (MRID 00126661). The compound also displayed negative
activity in tests to detect chromosome aberrations, including dominant
lethal tests in rats and mice (MRID 00129059), and a mouse
micronucleus assay (Last, et al., 1981). Trifluralin was also negative in
another mutagenicity assay for the in vivo induction of sister chromatid
exchange in Chinese hamster bone marrow (MRID 00126662).
g. Metabolism
General Metabolism; Studies in rats using radioactive trifluralin have
indicated that the compound is not readily absorbed from the
gastrointestinal tract after oral intake. However, of the trifluralin that is
absorbed, essentially all of it is completely metabolized and eliminated
within 3 days after oral administration. About 80% of the administered
dose was eliminated in the feces and the remainder in the urine. About
30 to 40 different metabolites are excreted in the urine, each one
representing less than 1% to 2% of the total radioactivity in the urine
(MRID 41218901).
17
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h.
Dermal Penetration
The estimated approximate rate of dermal absorption is 1% of
the applied dose based on available data that indicates that less than 1%
of the applied dose is dermally absorbed (Toxicology Endpoint
Selection Document 9/9/94).
i. Other Toxicity Endpoints
Reference Dose; The RfD for trifluralin is 0.024 mg/kg/day as
determined from the one-year feeding study in dogs. The NOEL was
2.4 mg/kg/day (MRID 42447001). A safety factor of 100 was applied
to account for the inter-species extrapolation (factor of 10) and intra-
species variability (factor of 10).
Carcinogenicity Classification; Trifluralin has been classified as a
Group C, possible human carcinogen by the OPP Carcinogenicity Peer
Review Committee (4/4/86). The Qt* for quantitation of risk is 0.0077
mg/kg/day"1.
Additional Toxic Endpoints; No acute dietary, short term
occupational or residential nor intermediate term occupational or
residential endpoints were identified.
2. Exposure Assessment
a. Dietary
Plant metabolism data for trifluralin are adequate. Except for
alfalfa forage, alfalfa hay, flax straw, and sunflower forage, the field
trial data are adequate. The residue study on corn forage, fodder, and
silage is adequate pending submission of acceptable data validating the
analytical method (Method No. GRM92.11) at or below the established
0.05 ppm tolerance level. Adequate processing studies have been
submitted for field corn, cottonseed, grapes, hops, citrus, peanuts,
plums, potatoes, sorghum grain, soybeans, sugar beets, sugarcane,
sunflower seed, tomatoes, and wheat. Based on these data, food/feed
additive tolerances for residues of trifluralin are not required for the
processed commodities of barley, field corn, cottonseed, flax, grapes,
hops, citrus, peanuts, plums, potatoes, rape seed, safflower seed,
sorghum grain, soybeans, sugar beets, sugarcane, sunflower seed,
tomatoes, and wheat. Peppermint and spearmint processing data remain
outstanding. Test sample storage information remains outstanding for
18
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asparagus, peppermint, and spearmint. Due to test sample storage
stability concerns, one additional field trial should be conducted on
carrots, grapes, and barley/wheat forage, hay, and straw. Acceptable
storage stability studies have been conducted on numerous commodities
matrices. The existing data indicate that the established tolerances
and/or the revised tolerance recommendations made in this report are
supported.
The qualitative nature of the residue in animals is adequately
understood. Based on available ruminant and poultry metabolism data,
the Agency has concluded that there is no reasonable expectation of
finite residues of trifluralin in animal commodities. Therefore, there is
no need for tolerances for trifluralin residues in meat, milk, poultry and
eggs.
The dietary exposure assessment for trifluralin is based on
tolerance level residues and proposed tolerance levels as specified in the
tolerance reassessment summary with the exception of carrots, wheat,
tomatoes, and sugarcane. Anticipated residue estimates for carrots,
wheat, tomatoes, and sugarcane, as well as for their processed food
commodities, will be used for the carcinogenic risk assessment. Though
confirmatory, receipt of the required sample storage information and
bridging field trials will increase confidence with respect to the risk
assessment.
Plant Metabolism; The qualitative nature of the residue in plants is
adequately understood based on acceptable field corn and mustard
green metabolism studies supported by supplemental carrot, cotton,
peanut, soybean, and sweet potato metabolism data. The residue of
concern in plants is trifluralin per se and the current tolerance
expression for plants is adequate (MRID 00024731, 00026054,
00093553, 00105720, 00105759, 00124905, 00125299, 41179001,
41179002, 41396801, 41396802).
Animal Metabolism: The qualitative nature of the residue in animals is
adequately understood based on acceptable poultry and ruminant
metabolism studies reflecting oral exposure. Studies conducted at
various feeding levels (including exaggerated levels) indicate that finite
trifluralin residues are not expected to occur in animal commodities
(MRID 00093636, 00105690, 00105772, 41233101, 41233102,
41286101).
19
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The Agency concludes that although radioactive residues in
animal tissues, milk, and eggs from exaggerated feeding levels were
incompletely characterized, further analytical work is not required given
the low levels of radioactive residues expected to result from the current
maximum theoretical dietary exposure estimates. Further, the Agency
concludes that there is no reasonable expectation of finite residues of
trifluralin in animal commodities. Therefore, there is no need for
tolerances for trifluralin residues in meat, milk, poultry and eggs as
prescribed under 40 CFR §180.6(a)(3).
Residue Analytical Methods - Plants and Animals; The
reregistration requirements for residue analytical methods are fulfilled.
Adequate methods are available for data collection and enforcement of
tolerances for residues of trifluralin per se in/on plant commodities. The
requirement for analytical method(s) for animal commodities has been
waived (MRID 00022793, 00047591, 00047639, 00059532, 00067371,
00067435, 00080320, 00105646, 00105689, 00105695, 00105720,
00105759, 00125303).
Storage Stability; The requirements for storage stability data are not
fully satisfied. Information concerning sample storage intervals and
conditions for asparagus and peppermint/spearmint magnitude of the
residue studies previously submitted and reviewed in the Trifluralin
Registration Standard remains outstanding.
In addition, due to test sample stability concerns, one additional
field trial must be conducted as bridging data at exaggerated rates on
each of the following crops in the major growing area: (i) barley or
wheat forage, hay and straw; (ii) carrots; and (iii) grapes.
Outstanding field trials and processing studies must have
supporting storage stability data. The Agency prefers that concurrent
storage stability studies be conducted with the field trials.
Magnitude of the Residue in Plants; The reregistration requirements
for magnitude of the residue in plants are fulfilled for the following
commodities: almonds (hull and nutmeats); apricots; asparagus; barley
(forage, grain, hay, and straw); beans (succulent, seed, forage, and
straw/hay); broccoli; Brussels sprouts; cabbage; cantaloupes;
cauliflower; carrots; celery; cherries; chicory (roots and tops); collards;
corn (grain and aspirated grain fractions); cotton (seed); cucumbers;
endive; flax (seed); garlic; grapefruit; grapes; hops; kale; lemons; lupin
(seed), mustard (greens and seed); nectarines; okra; onions (bulb and
20
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green); oranges; peaches; peanuts (nutmeats, hay, and hulls); peas
(succulent, seed, vines, and hay); pecans; peppermint (hay); peppers;
plums; potatoes; radishes (roots and tops); rape (seed); safflower (seed);
sorghum (forage, grain, fodder, and aspirated grain fractions); soybeans
(seed, forage, hay, and aspirated grain fractions); spearmint (hay);
squash (summer), sugar beets (roots and tops); sugarcane; sunflower
(seed); tangelos; tangerines; tomatoes; turnips (roots and tops); walnuts;
watermelon; and wheat (forage, grain, hay, straw, and aspirated grain
fractions). Adequate field trial data depicting residues of trifluralin
following treatments according to the maximum registered use patterns
have been submitted for the commodities listed above or have been
translated where appropriate.
Residue data for corn forage, fodder and silage are adequate
pending submission of acceptable method validation data. Additional
alfalfa forage and hay data are required to support the reregistration of
trifluralin. Residue data are no longer required for sunflower forage;
however, residue data are now required for rape forage. Alternatively,
sunflower forage data, if available, would be translated to rape forage.
Existing Special Local Needs (SLN) registrations for the uses of
trifluralin on clover and bermudagrass grown for seed production only
may be deemed non-feed uses by the Agency, if, like Washington state,
the states needing these SLN registrations ensure that adequate
legal/regulatory mechanisms are in place to prevent feed uses of the
seed crop(s) and forages, hays, straws from the seed crop(s). Otherwise,
residue data are required depicting residues of trifluralin in/on clover
forage and hay and bermudagrass forage and hay resulting from the
maximum use rates permitted to clover and bermudagrass to establish
tolerances on clover forage and hay and bermudagrass forage and hay.
There are two uses for which the Agency has no data, non-grass
forage/fodder/straw/hay and dill. These uses are unsupported and will
be deleted from the labels unless data are generated.
Based on changes to the Livestock Feeds Table, the Agency
currently recognizes cotton gin byproducts (commonly called gin trash)
as a raw agricultural commodity of cotton and residue data are required
depicting residues of trifluralin in/on cotton gin byproducts resulting
from the maximum registered use rate to cotton. A minimum of six (6)
field trials are required. These data will be considered confirmatory to
the reregistration eligibility decision for trifluralin.
21
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For additional guidance on sampling and geographical locations
for field trials the registrant should consult "EPA Guidance on Number
and Location of Domestic Crop Field Trials for Establishment of
Pesticide Residue Tolerances" issued 6/2/94. The need for additional
tolerances and revisions to the exposure/risk assessments will be made
upon receipt and evaluation of required data.
Magnitude of the Residue in Processed Food/Feed: Adequate
processing studies have been conducted on the processed commodities
of the following RACs: cottonseed, field corn, oranges, peanuts,
potatoes, grain sorghum, soybeans, sugar beets, sugarcane, sunflower
seed, and wheat. The available processing data indicate that residues in
the processed commodities will not exceed the currently established
tolerance on the associated RAC.
Available wheat processing data have been translated to barley
processed commodities.
Available cottonseed processing data have been translated to flax
processed commodities.
Available sunflower seed processing data have been translated to
rape seed and safflower processed commodities.
Acceptable field trials have been conducted at exaggerated
application rates (up to 5x) which are adequate to demonstrate that
residues of trifluralin are not likely to concentrate in the processed
commodities of the following RACs: grapes, hops, plums, and
tomatoes.
Potato processing data (MRID 42514501) have previously been
reviewed by the Agency and deemed adequate to satisfy data
requirements. These data demonstrate that residues of trifluralin do not
concentrate in flakes and chips but do concentrate in wet peel (5x) and
dried peel (280x). Based on the submitted study, the Agency
recommended that a feed additive tolerance for residues of trifluralin in
processed potato waste should be established using the maximum
theoretical concentration of residues in dry peel. However, since that
time, the Agency has updated the Livestock Feeds Table for
Subdivision O and now establishes feed additive tolerances for
processed potato waste based on the maximum concentration factor
observed for residues in/on wet peel. Because the potato processing
study was conducted at exaggerated application rates (up to 5x)
22
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resulting in trifluralin residue levels in/on processed wet potato peel
samples (ranging from <0.05 ppm to 0.05 ppm) equal to or below the
currently established tolerance for potatoes (0.05 ppm), the Agency
concludes that a feed additive tolerance for residues of trifluralin in/on
processed potato waste is not required. The currently established
tolerance for residues of trifluralin in/on potatoes will apply to
processed potato waste.
The Agency no longer recognizes any processed commodities of
alfalfa and beans. No alfalfa or bean processing data are required.
Processing studies conducted on peppermint oil and spearmint
oil showed that residues of trifluralin concentrated in both commodities.
Because the actual concentration factors could not be determined, new
peppermint and spearmint processing data are required on a
confirmatory basis. It should be noted that the available processing data
are sufficient for the purposes of determining that residues in ready-to-
eat foods prepared from the mint oil will not exceed the existing 408
tolerances.
Magnitude of the Residue in Meat, Milk, Poultry, and Eggs; The
data requirements for magnitude of trifluralin residue in meat, milk,
poultry, and eggs have been waived based on the low levels of
radioactive residues from the animal metabolism studies. This is
considered to be a 40 CFR §180.6 category 3 with respect to the need
for tolerances for trifluralin residues in meat, milk, poultry and eggs.
Category 3 of 40 CFR §180.6 states that "it is not possible to establish
with certainty whether finite residues will be incurred, but there is no
reasonable expectation of finite residues."
Confined/Field Rotational Crops; Confined rotational crop data are
deemed adequate to satisfy reregi strati on data requirements. Limited
field rotational crop studies are not required and tolerances are not
needed for trifluralin residues in rotational crops (MRID 41661102).
b. Occupational and Residential
Handler (Mixer/Loaders and Applicators) Exposure: The Agency
has determined that there is potential for exposure to mixers, loaders,
applicators, or other handlers during usual use patterns associated with
trifluralin. The Agency is concerned specifically about potential
exposures arising from mixing and loading liquids and granulars, aerial
application, groundboom application, granular application at planting,
23
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3.
granular spreader cultivator mounted, residential .push-type spreaders,
whirly-bird spreaders, hand-held sprayers, and backpack sprayers.
Post Application Exposure: The Agency has determined that there is
potential exposure to persons entering treated sites after application is
complete. The Agency is specifically concerned about potential post-
application exposure arising from re-entering treated turf
(e.g.,residential lawns, recreational areas, and sod farms), ornamental
(especially nursery), and established food/fiber crop sites.
Post-application exposure data were not required previously by
the Agency, since no toxicological concerns were identified at that time.
No post-application exposure data are available to conduct an
exposure/risk assessment, however, trifluralin was one of the chemicals
included in a generic Data Call-In Notice requiring exposure data for
pesticides used on residential lawns. The data generated will allow the
Agency to more accurately estimate both professional and homeowner
exposure to pesticides applied to the home lawn.
Exposure values can be found in the combined exposure/risk
table in section in.B.3.b.
Risk Assessment
a. Dietary
Using anticipated residues and percent of crop treated data, the
Agency has concluded that the chronic dietary risk posed by trifluralin
is not of concern. The upper bound cancer risk does not exceed the
level of concern for excess lifetime dietary cancer risk.
The Dietary Risk Evaluation System (ORES) chronic analysis
used tolerance level residues to calculate the Theoretical Maximum
Residue Contribution (TMRC) for the overall U.S. population and 22
population subgroups. Refinements in residue information were
considered in calculating the Anticipated Residue Contribution (ARC)
for those same population groups. Anticipated residues were estimated
for carrots, wheat, tomatoes and sugarcane. Percent of crop treated
information was included in the estimation of the anticipated residue
contribution. These exposure estimates were then compared to the RfD
for trifluralin.
24
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Using Tolerances; The Theoretical Maximum Residue Contribution
(TMRC) for the overall U.S. population and highest exposed subgroup
from published tolerances supported in reregistration are listed below.
"', / ", , !?',' V,'
SlIJJgKHtp '' ' ' '"'
U.S. population
Non-nursing Infants
, , " '
, " Ixp0$ure{»tg/kg^^
0.000724
0.002438
'» „ " r
: % Reference Dose ' '
3
10
Using Anticipated Residues and Percent of Crop Treated Data; The
Anticipated Residue Contribution (ARC) for the overall U.S. population
from published uses is listed below.
- '•* Su&group
U.S. population
Non-nursing Infants
Exposureittig/kg/tSiiy)
0.000126
0.000429
•••- % Reference Bose
1
2
For all the DRES subgroups the %RfD appears to be within a
safe margin, even when considering tolerance levels and 100% crop
treated. The chronic dietary risk posed from trifluralin is not of concern.
Upper Bound Carcinogenic Exposure; The upper bound
carcinogenic risk from food uses of trifluralin for the general U.S.
population was calculated using the following equation:
Upper Bound Cancer Risk = Dietary Exposure (ARC) x Qt"
Based on a Q/ of 0.0077 (mg/kg/day)"1, when using refinements
in residues and percent of crop treated information, the upper bound
cancer risk was calculated to be 1.0 x W6 (viz. 0.96 x 10"6), contributed
through all the published uses for trifluralin, including mung beans,
which are not being supported for reregistration. The upper bound risk
does not exceed the level of concern for excess lifetime dietary cancer
risk.
b. Occupational and Residential
Handler (Mixer/Loader/Applicator); Based on the use patterns and
potential exposures, nine major handler exposure scenarios were
identified for trifluralin:
25
-------
(1) mixing/loading the liquid formulation
(2) loading granulars for ground and aerial application
(3) aerial application of liquids
(4) groundboom application of liquids
(5) granular row planter application
(6) granular spreader cultivator application
(7) mixing/loading and applying using a residential push-type spreader
(8) mixing/loading and applying with a residential "whirly-bird"
spreader.
(9) application using backpack sprayer
The exposure scenarios are presented in the table below along
with the corresponding exposure/risk assessment. Each exposure
assessment in the table below is based on the assumption that workers
wear long pants, shoes and socks, long sleeved shirts and no gloves,
except handlers on granular 6 and 8-row planters who were wearing
double layered clothing (coveralls, over long sleeved shirt and long
pants) and chemical resistant gloves and were located inside enclosed
cabs), and mixer/loaders of liquids who were wearing chemical resistant
gloves.
The Agency has calculated the exposure and resulting risk values
for the exposure scenarios. The occupational/residential cancer
exposure/risk assessment for all uses indicates a level of risk that does
not exceed 10~s for occupational handlers or 10"7 for residential handlers.
Post-Application; No data are available to calculate post-application
exposures and risks following trifluralin treatments. A March, 1995
Data Call-in Notice for trifluralin pesticide products' use on residential
lawns will generate data that will allow the Agency to more accurately
estimate both professional and homeowner exposure to pesticides
applied to lawns.
Although the Agency has no data, the dermal absorption value is
very low (one percent) and inhalation exposures are not a concern for
post-application scenarios. These factors suggest that occupational and
residential post-application exposures probably would be no higher than
exposures to occupational handlers. Since the occupational/residential
cancer exposure/risk assessment for all uses indicates a level of risk that
does not exceed 10"s for occupational handlers or 10"7 for residential
handlers, the Agency does not anticipate that the exposure/risk
assessment for post-application scenarios would exceed 10"5 for
26
-------
occupational post-application exposures or 10"7 for residential post-
application exposures.
27
-------
.S
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Dermal unit exposures are repo
lognormal distributed data, aritl
for PPE in these scenarios.
Inhalation Exposure Values are
Team 1.15 Lawn Weed and Fee
62719-93; Trilin 5 label, EPA I
Values represent the maximum
Potentially Daily Dose (me/kg/
. a a -0 «
O
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"3 j3 S3 *o ^ §5 S
a S-S^-So-a
Absorbed LADD mg/kg/day =
Year)*(35yrs/70yrs)]
Private applicator is defined as
Commercial applicator is defini
Risk = [Absorbed LADD (mg/l
Long pants, long sleeved shirt,
Double layer of clothing and gl
Enclosed cab, long pants, long i
w „ ^ „ , s ;
CO
-------
Table 2. Exposure Scenario Descriptions for Trifluralin
Exposure Scenario (Seen. #)
Data Source | Clothing Scenario*
Equipment
Standard Assumptions*
Comments'
Mixer/Loader Exposure
Liquids (I)
Granular (II)
PHEDV1.1
PHEDV1.1
Long pants, long
sleeves, chemical
resistant gloves
Long pants, long
sleeves, no gloves
Open mixing for
aerial or
chemigation
applications
Open mixing for
aerial
applications
800 acres
800 acres
Acceptable grades;
Dermal = 53 to 122 replicates;
Inhalation = 85 replicates;
High confidence in dermal and
inhalation data.
All grades for dermal;
Acceptable grades for inhalation;
Dermal = 10 to 78 replicates
Inhalation = 58 replicates;
Low confidence in dermal and high
confidence for inhalation data.
Applicator Exposure
Aerial (III)
Groundboom (IV)
Granular 8-row Planter (V)
Granular Spreader Cultivator
Mounted (VI)
PHEDV1.1
PHEDV1.1
PHEDV1.1
PHEDV1.1
Long pants, long
sleeves, no gloves
Long pants, long
sleeves, no gloves
Two layers of
clothing; chemical
resistant gloves
Long pants, long
sleeves, no gloves
Aircraft; all cab
types
Open Cab
6 and 8-row
planters, enclosed
cab
Cultivator
mounted or pull-
behind; Ag or
Turf; closed cab
800 acres
80 acres
80 acres
80 acres
Dermal grades A,B,C;
Inhalation all grades;
Dermal = 1 to 17 replicates
Inhalation = 17 replicates;
Low confidence in' dermal and
inhalation data.
Dermal and inhalation grades =
acceptable grades;
Dermal = 23 to 33 replicates;
Inhalation = 22 replicates;
High confidence in dermal and
inhalation data.
Acceptable grades;
Dermal = 2 to 17 replicates;
Inhalation = 17 replicates
Low confidence in dermal data.
High confidence in inhalation data.
Acceptable grades;
Dermal = 24 to 25 replicates;
Inhalation = 25 replicates;
High confidence in dermal and
inhalation data.
Mixer/Loader/Applicator
Residential Push-type
Spreader (VI I)
Whirly-bird Spreader (VIII)
Backpack Sprayer (K)
PHEDV1.1
PHEDV1.1
PHEDV1.1
Long pants, long
sleeves, no gloves
Long pants, long
sleeves, no gloves
Long pants, long
sleeves, no gloves
Rotary spreader
Belly grinder
Backpack
Sprayer
1 acre
1 acre
(H) 5 gallons
(O) 40 gallons
Dermal grade C; inhalation
acceptable grades; Dermal = 15
replicates;
Inhalation = 15 replicates;
Medium confidence in dermal data,
high confidence for inhalation data.
Dermal grades = 9A and 36C;
Inhalation grades = acceptable;
Dermal = 23 to 45 replicates;
Inhalation = 40 replicates;
Medium confidence in dermal data,
high confidence for inhalation data.
Dermal grades = A,B,C; Inhalation
grades = acceptable;
Dermal = 9 to 11 replicates;
Inhalation =11 replicates;
low confidence in dermal and
inhalation data.
Clothing scenario represents actual monitored exposure data. The dermal exposure values on Table 1 have not been altered for simulate clothing protection
factors.
Standard Assumptions based on an 8-hour work day as estimated by OREB. BEAD data were not available.
"Acceptable grades," as defined by OREB SOP for meeting Subdivision U Guidelines, are grades A and B for dermal and inhalation, and grade C for hand rinse
method. All grades that do not meet OREB's SOP are listed individually.
29
-------
C. Environmental Assessment
1. Ecological Toxicity Data
The Agency has adequate data to assess the risk of trifluralin to nontarget
terrestrial organisms. However, the Agency does not currently have data to assess the
toxicity of trifluralin on seedling emergence. A seedling emergence study has been
required and is considered confirmatory.
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
In order to establish the acute and subacute toxicity of trifluralin
to birds, the following tests are required using the technical grade
material:
* one avian single-dose oral (LDSO) study on one species
(preferably mallard or bobwhite quail)
* two subacute dietary studies (LC50) on one species of waterfowl
(preferably the mallard duck) and one species of upland game
bird (preferably bobwhite quail)
A'riaaAOTteQralToxfcttyFHKtteg* '"' >...'.'''.'.''...'..
Species
Northern
Bobwhite
Mallard
% a.i.
96.7
96.7
LDS, mg/kg
>2000
>2000
Citation (MRID)
00137573
Reported in Hudson etal,
1984
Toxicity
Category
Practically
nontoxic
Practically
nontoxic
Fulfills Guideline
Requirement
Yes
Yes
" ' <• ' Avian SuhacttteOletoryToxidiy'FiradJng*
Species
Northern
Bobvvhitc
Mallard
% a.i.
99.96
99.96
LC5, ppm
>5000
>5000
Citation (MRID)
00138857
00138858
Toxicity
Category
Practically
nontoxic
Practically
nontoxic
Fulfills Guideline
Requirement
Yes
Yes
These results indicate that trifluralin is practically nontoxic to
birds on an acute oral and subacute dietary basis. The guideline
requirements are fulfilled (MRID 00137573, 00138857, 00138858).
30
-------
(2) Birds, Chronic
Avian reproduction studies are required when birds may be
exposed repeatedly or continuously through persistence,
bioaccumulation, or multiple applications, or when mammalian
reproduction tests indicate reproductive hazard. Current product
labeling of trifluralin allows several applications of the end-use product
per growing season. Also, the chemical is known to be persistent and
nonmobile in a vital (microbially active) soil environment.
« ,
Species
Northern
Bobwhite
Mallard
Duck
Northern
Bobwhite
Mallard
Duck
' " Avian Reproduction Findings , , ,
% a.L
99.6
99.6
96.0
96.0
NOEC ppm
Not
determined
Not
determined
452.3
910.5
LOEC ppm
Not determined
Not determined
910.5
Not determined
Endpoints affected
None - Long term
exposure at levels <50
ppm will not significantly
affect reproductive
success
Although there was
increased cracked eggs at
50 ppm it was not enough
of a difference (2.4%) to
be able to determine an
LOEC.
Cracked eggs as a
percentage of eggs laid
None
Citation
(MRID)
00131134
00131132
40334706
40334704
Fulfills Guideline
Requirement
Yes
Yes
Unreviewed data*
Unreviewed data*
The test appears to be scientifically sound based on cursory review; however, the NOEC and LOEC are subject to change resulting from
further study review.
The results indicate that adverse reproductive effects may occur
as low as 910.5 ppm. The guideline requirements are fulfilled (MRID
00131132, 00131134, 40334704, 40334706).
(3) Mammals
Wild mammal testing is required on a case-by-case basis,
depending on the results of the lower tier studies such as acute and
sub acute testing, intended use pattern, and pertinent environmental fate
characteristics. Acute toxicity studies show that trifluralin is not acutely
toxic to the animals tested. The herbicide has been tested in animals via
oral, dermal inhalation and ocular routes of exposure, and the results
show only minor effects. Based on these conclusions and expected
exposure, wild animal testing was not required for trifluralin.
31
-------
(4) Insects
A honey bee acute contact LDSO study is required if the proposed
use will result in honey bee exposure. Based on the use pattern, which
includes outdoor terrestrial uses, honey bee exposure to trifluralin was
expected and therefore acute testing was required.
-- ' ?&ntefketfcse«4T«sirity£ta«tJnss
Species
Honey
Bee
% o.l.
Not
reported
LD» /4g/bee
24-hour contact > 100
24-hour oral > 50
Citation (M RID)
05001991
'
Toxicity Category
Practically nontoxic
,,_. fff
, ' ' ' ' !
Fulfills Guideline
Requirement
Yes
There is sufficient information to characterize trifluralin as
practically nontoxic to bees. The guideline requirement is fulfilled
(MRID 05001991).
b. Toxicity to Aquatic Animals
(1) Freshwater Fish - Acute Toxicity
In order to establish the toxicity of trifluralin to freshwater fish,
the minimum data required on the technical grade of the active
ingredient are two freshwater fish toxicity studies. One study should
use a coldwater species (preferably the rainbow trout), and the other
should use a warmwater species (preferably the bluegill sunfish).
% JFr«sh,waterHshAcut«ToxldferBtRditnas *....
Species
Rainbow trout
BlucRill sunfish
Fathead minnow
Channel Catfish
Largcmouth bass
Goldfish
% a.i
95.9
95.9
95.9
95.9
95.9
46
LC5, ppb
41
58
105 ,
2200
75
145
Citation (MRID)
40094602
40094602
40094602
40094602
40094602
40094602
Toxicity Category
very highly toxic
very highly toxic
highly toxic
moderately toxic
very highly toxic
highly toxic
'
Fulfills Guideline
Requirement
Yes
Yes
Yes
Supplemental
Supplemental
Supplemental
The results of the acute toxicity studies indicate that trifluralin is
highly to very highly toxic to both cold and warmwater fish. The
guideline requirements are fulfilled (MRED 40094602).
32
-------
Early Life-Stage Fish: An early life-stage test for fish is required if the
product is applied directly to water or expected to be transported to
water from the intended use site, and when the pesticide is intended for
use such that its presence in water is likely to be continuous or recurrent
regardless of toxicity; or if any acute LC50 or EC50 is greater than 1
mg/L; or if the EEC in water is equal to or greater than 0.01 of any acute
EC50 or LC50 value; or if the actual or estimated environmental
concentration in water resulting from use is less than 0.01 of any acute
EC50 or LC50 value and any of the following conditions exist: studies of
other organisms indicate the reproductive physiology offish or
invertebrates may be affected; or physicochemical properties indicate
cumulative effects; or the pesticide is persistent in water (e.g., half-life
greater than 4 days). Several of these scenarios apply to trifluralin,
therefore, the fish early life-stage test was required.
- -, ,
Species
Rainbow
trout
' % •>
% a.L
99.86
-
NOEC
ppb
t.14
'&,
Ksfe Early lifc-l^sKBTffxtcity Einflinas
LOEC
ppb
2.18
MATC
ppb
1.58
Citation (M RID)
41386202
Endpoints
Affected
larval fish
length
Fulfills Guideline
Requirement
Yes
The results indicate that trifluralin may result in adverse chronic
effects to fish at levels as low as 2.18 ppb. The guideline requirement is
fulfilled (MRID 41386202).
Fish Life-Cycle: The fish life-cycle test is required when an end-use
product is intended to be applied directly to water or is expected to be
transported to water from the intended use site, when any of the
following conditions apply: the EEC is equal to or greater than one-
tenth of the NOEL in the fish early life-stage or invertebrate life-cycle
test; or if studies of other organisms indicate the reproductive
physiology offish may be affected. Because many of these conditions
apply to trifluralin, fish life-cycle testing was required.
Species
Fathead
minnow
"
% a.i.
97
"
NOEC
PPb
1.9
Ffeh UKfe-€y«le forictty Jfcwlinas
LOEC
ppb
5.1
MATC
ppb
3.5
Citation (MRID)
05008271
Endpoints
Affected
Not reported
Fulfills Guideline
Requirement
Yes
33
-------
The results indicate that chronic effects to fish may occur from
the use of trifluralin at levels as low as 5.1 ppb. The guideline
requirement is fulfilled (05008271).
Field Monitoring: Vertebral dysplasia has been related to trifluralin
exposure in a study using sheepshead minnow (Couch et al. 1979).
Therefore vertebral dysplasia was evaluated in an aquatic field
monitoring study submitted to the Agency (MRID 00155972,
00155973, 00155974, 00155975, 00155978). Results of that study
indicate that, when used on soybeans, trifluralin will be transported to
aquatic habitat where it will be biologically available to aquatic
organisms. Incidence of vertebral anomalies was found to be related to
trifluralin exposure, despite the fact that concentrations were less than
NOEL values from life-cycle tests with aquatic organisms.
Trifluralin may also contribute at non-detectable residues along
with other environmental or chemical influences to the increased
evidence of vertebral anomalies in fish. The significance to fish
populations of this contribution is not clear. Some doubt still remains as
to whether trifluralin poses a serious threat to fish in areas of high
trifluralin usage. The results of the field trial do not negate the
presumption of risk for which the requirement was proposed.
The Agency will explore monitoring efforts with the technical
registrants of trifluralin to further evaluate vertebral developmental
abnormalities in fish.
Vertebral Lesion Study; Based on the results from the field
monitoring study, the Agency required a fish vertebral lesion study.
The study submitted has been classified as invalid because of an
inadequate control group, however, additional data are not required.
Trifluralin contamination in both the acetone and water controls led to
detectable concentrations in the fish at termination. Also, the stock fish
that were used as a negative control were three to four weeks older than
the test organisms at the time of radiographic exams. The stock fish had
high incidence of wavy ribs (27.5%) and vertebral anomalies (23.8%).
The Trifluralin Data Development Consortium (TDDC) has submitted a
rebuttal to the review that classified this study as invalid. This rebuttal
is currently being evaluated by the Agency. The Agency will explore
with TDDC the appropriateness of a field monitoring study following
the review of the rebuttal submission (MRID 42439601).
34
-------
(2) Freshwater Invertebrates
Aouatic Invertebrate Toxicitv: The minimum testing required to
assess the hazard of trifluralin to freshwater invertebrates is a freshwater
aquatic invertebrate toxicity test, preferably using first instar Daphnia
magna or early instar amphipods, stoneflies, mayflies, or midges.
','
Species
Daphnia magna
Daphnia pulex
Simocephalus
G, fasciatus
Pteronarcys
"•••<•
95.9
95.9
95.9
95.9
95.9
,,,
EC5,ppb
560
625
900
LCj,, = 2200
LCjo = 2800
teferate?»xl«HyJM*HHn
Citation
(MRID)
40094602
40094602
40094602
40094602
40094602
Toxicity
Category
highly toxic
highly toxic
highly toxic
moderately toxic
moderately toxic
Fulfills Guideline
Requirement
Yes
Yes
Supplemental
Supplemental
Supplemental
There is sufficient information to characterize trifluralin as
moderately to highly toxic to aquatic invertebrates. The guideline
requirement is fulfilled (MRID 40094602).
Life-Cvcle Aquatic Invertebrates; Data from life-cycle tests with
aquatic invertebrates are required if the product is applied directly to
water or is expected to be transported to water from the site of intended
use, and when the pesticide is intended for use such that its presence in
water is likely to be continuous or recurrent regardless of toxicity; or if
any acute LC50 or EC50 is greater than 1 mg/L; or if the EEC in water is
equal to or greater than 0.01 of any acute ECSO or LC50 value; or if the
actual or estimated environmental concentration in water resulting from
use is less than 0.01 of any acute EC50 or LC50 value and any of the
following conditions exist: studies of other organisms indicate that the
reproductive physiology offish or invertebrates may be affected; or
physicochemical properties indicate cumulative effects; or the pesticide
is persistent in water (e.g. half-life greater than 4 days). Because several
of these scenarios apply to trifluralin, the invertebrate life cycle test was
required.
35
-------
/< /, ~ *Ai
Species
Daphnla
magna
Daphnla
ntagna
% a.L
99.86
97
NOEC
ppb
50.7
2.4
mattcInverterf^vrfeT^c^^dfei
LOEC
ppb
N/A
7.2
MATC
ppb
>50.7
4.8
Citation
(MRID)
41386201
05008271
s.
Endpoints
Affected
None
Survival
"' ",
Fulfills Guideline
Requirement
Yes
Yes
The results indicate that chronic effects to aquatic invertebrates
may occur from the use of trifiuralin at levels as low as 7.2 ppb. The
guideline requirement is fulfilled (MRID 41386201, 05008271).
(3) Estuarine and Marine Animals
Acute toxicity testing with estuarine and marine organisms is
required when an end-use product is intended for direct application to
the marine or estuarine environment or when the intended use is such
that the pesticide is expected to reach that environment in significant
concentrations.
The requirements under this category include a 96-hour LC50 for
an estuarine fish, a 96-hour LC50 for shrimp, and either a 48-hour
embryo-larvae study or a 96-hour shell deposition study with mollusks.
','•' ' ,'' " ''"'
,* '" E8taartn«MadBBActtfeT
-------
Toxicity to Plants
(1) Terrestrial
Currently, terrestrial plant testing (seedling emergence and
vegetative vigor) is required for herbicides that have terrestrial non-
residential outdoor use patterns and that appear to move off site of
application through volatilization (vapor pressure >1.0 x 10"smm Hg at
25°C) or drift (aerial or irrigation); or which may have endangered or
threatened plant species associated with the site of application. Tier n
vegetative vigor toxicity data on the technical material for the three
most sensitive species is listed below:
.,
Species
Dicot - cucumber
Monocot - corn
Dicot - radish
% a.L
95.7
95.7
95.7
^onlaract TerresjEriat Plant Toxicity Ftadtaas- Vegetative Visor
Height
ECj5lb
a.L/A
0.800
1.47
0.936
NOELlb
a.L/A
0.50
0.125
0.25
Fresh Weight
ECM Ib
a.L/A
0.796
1.09
1.23
NOEL Ib
a.L/A
0.25
0.50
0.50
Citation
(MRID)
41934503
41934503
41934503
Fulfills
Guideline
Requirement
Yes
Yes
Yes
The results indicate that terrestrial plants may be adversely
affected at levels as low as 0.796 ib a.i./A, which is far below the
maximum label rate of 4 Ib a.i./A for sugarcane and 2 Ib a.i./A for all
other crops. The guideline requirement for vegetative vigor is fulfilled
(MRED 41934503).
Tier I Seed Germination testing (MRID 41934501) indicated
that, of the ten species tested, greater than 25% inhibition occurred in
the onion and cabbage tests, therefore, Tier II seed germination testing
was required on these two species. Tier n toxicity data for these two
species is summarized in the following table:
Species
Onion - radicle
length
Cabbage
- '
% a.L
95
95
% "•'" TieFirgccd<;crnrijvationi'F«xidfy:FiH4
Citation (MRID)
42695601
42695601
Fulfills Guideline
Requirement
Yes
Yes
37
-------
These results indicate that nontarget terrestrial plants may be
adversely affected at levels as low as 0.25 Ib a.i./A, which is far below
the maximum label rate of 4 Ib a.i./A for sugarcane and 2 Ib a.i./A for all
other crops. The guideline requirement for tier II seed germination
testing is fulfilled (MRID 42695601).
The Agency does not currently have data to assess the toxicity of
trifluralin on seedling emergence. Although toxicity to nontarget
terrestrial plants can be estimated from the available data, a
comprehensive plant risk assessment cannot be completed without
seedling emergence data. Seedling shoot effects as well as root effects
are expected from trifluralin exposure, based upon the following:
• The publication developed from the 1989 Purdue
University Herbicide Action Course (Warren and Hess,
1989) states that trifluralin is a mitotic poison that stops
the growth of roots and shoots of seedlings, as is the case
for most dinitroanaline chemicals. The section of that
publication entitled "Inhibitors of Roots Only in
Seedlings" does not include trifluralin; also,
• Literature has been provided by the registrant which
states that trifluralin controls weeds by interrupting the
development of new cells in roots and shoots of
susceptible seedlings.
(2) Aquatic
Currently, aquatic plant testing is required for any herbicide
which has outdoor non-residential terrestrial uses that may result in off-
site movement of pesticide by runoff or by drift (aerial or irrigation).
The following species are to be tested: Selenastrum capricornutum,
Lemna gibba, Skeletonema costatum, Anabaenaflos-aquae, and a
freshwater diatom.
Tier n toxicity data on the technical material is listed below:
Sosntarast AflaaJk Plant TwdcMy JfrndinE*
Species
Navicula pelltcttlosa
Lemna sibba
%a.L
97.92
95
EC5,
ppb
15.3
43.5
NOEC ppb
undetermined
undetermined
Citation (MRID)
42834102
42834104
Fulfills Guideline
Requirements
Yes
Yes
38
-------
X
....*.:.•;"...'. '..' ' ?..'..-:....??. Wm&rK<4.&qwtic^i&%$xicify$in$mzs: t ,,
Species
Selenastrum
capricomutum
Skeletonema costatum
Anabaena flos-aquae
% a.L
99.86
97.92
97.92
ECS.
ppb
7.52
28
>339
NOEC ppb
5.37
4.6
89
Citation (MRID)
41934502
42834101
42834103
Fulfills Guideline
Requirements
Yes
Yes
Yes
2.
In the studies listed above, the concentrations of trifluralin
decreased to non-detectable levels between day 1 and day 5. Because
of this, the toxicity values may be conservative in determining the full
degree of toxicity to aquatic plants. The plants in these studies may
have been exposed to concentrations of trifluralin much lower than the
values used to determine the toxicity estimates reported, therefore,
trifluralin is likely to be more toxic to these species than these studies
report (MRID 42834103, 42834102, 41934502, 42834101, 42834104).
Environmental Fate
a.
Environmental Fate Assessment
The available information on the properties of trifluralin in the
environment suggest that the chemical is expected to be moderately persistent.
It is not expected to be mobile, as a consequence of adsorption to soil. Risks to
water resources, ground water and surface water are discussed in detail in
Section "c." below. Trifluralin may contaminate surface water by spray drift,
and under some circumstances by runoff. Despite the low mobility of
trifluralin, the USEPA Pesticides in Ground Water Data Base indicates
detections in 10 states. However, the validity arid significance of the detections
is questionable on several grounds which are discussed below in section c.(l).
The available data, represented by supplemental and acceptable studies,
suggest the following conclusions regarding mechanisms of dissipation in the
field. Although trifluralin is volatile, in the field it dissipates primarily by soil
binding and (secondarily) by biotic degradation. For trifluralin to be effective,
it has to be incorporated into the soil at the time of application. Incorporation
limits dissipation via surface active processes, primarily volatilization and
photodegradation. Once incorporated, soil binding is the initial route of
dissipation. This is followed by biotic degradation processes with a half life of
116 to 201 days. A number of transitional degradates have been identified.
39
-------
Laboratory data indicate that trifluralin is not mobile in sandy loam,
loam, and clay loam soils. Surface volatilization of trifluralin is controlled by
soil moisture and temperature. Results based on laboratory data appear to be
confirmed by supplemental field data which indicate trifluralin dissipates with a
field half life of 29 to 149 days with no detection of trifluralin below six inches
depth.
In order for the submitted studies to fulfill guideline data requirements,
confirmation of analytical procedures should be submitted. It is not likely that
the additional information requested will change the overall qualitative
assessment. However, the additional information may bear on the confidence
in the data, and is expected to provide a better understanding of the
environmental fate properties of the chemical. Also, the additional information
could be relevant for a quantitative assessment of trifluralin exposure.
b. Environmental Fate and Transport
In order for the submitted laboratory and field studies to be acceptable
to fulfill the data requirements, confirmatory analysis (preferably MS) is
needed. Separations such as those based on TLC should be confirmed by
another analytical method.
(1) Degradation
Hydrolysis: The data requirement is not fulfilled at this time. The
registrant is supporting a study (MRID 00131135) that was found to be
acceptable in 1984-1985. Comparison of that study to a study of
photodegradation in water (MRID 40560101) indicates a discrepancy.
Trifluralin was reported to be substantially more stable in the hydrolysis
study than for the dark controls in the study of photodegradation in
water. In order to fully understand the degradation and dissipation of
trifluralin, this apparent discrepancy needed to be addressed. The
registrant has submitted information addressing the discrepancy which
is currently under review.
Photodegradation in Water: The submitted study supplies
supplemental data and is scientifically valid. However, it cannot be
used to fulfill the data requirement at this time, but may be upgradable
when the following points are adequately addressed:
• As described for the hydrolysis data requirement, there is
a discrepancy between the dark control half life (about 20
days) and the relative stability reported for the hydrolysis
40
-------
study. The reason for the difference is not apparent at
this time.
• Trifluralin appears to volatilize in preliminary testing.
For a complete environmental fate assessment,
measurements are needed of the fractions of volatile and
nonvolatile parent and degradates over the course of the
test. . ••
The study reports that trifluralin degraded with a half-life of 8.93
hours in a sterile pH 7 aqueous buffer solution when exposed to a light
source. In the dark control, trifluralin degraded with a half-life of 485
hours (or about 20 days). The major degradates identified in the
samples exposed to light (with maximum percent of applied) were:
(47.4%)2-ethyl-7-nitro-5-trifluoromethylbenzimidazole;
( 9.6%) 5-trifluoromethyl3-nitro-l,2-benzene diamine; and
(53.8%) 2-ethyl-7-nitro-l-propyl-5-trifluoromethylbenzimidazole
. The fraction of applied radioactivity recovered as volatile residue
was about 55% for control samples and about 70% for light-exposed
samples. The registrant has submitted information to address the cited
deficiencies that is currently under review (MRDD 40560101).
Photodegradation on Soil; The available study of photodegradation
on soil is scientifically valid and can be used as supplemental data, but
cannot be used to fulfill the data requirement. In order to validate the
analytical data, a confirmatory analysis (preferably MS) is needed in
addition to comparison to the Rf of reference standards. There are
guideline concerns [soil moisture and sieve size were not furnished and
a discrepancy in the half-life for photodegradation on soil control
samples (66 days) and for aerobic soil metabolism data (189 days)] in
the study methodology, as well. However, the Agency believes that
repeating this study will not provide significant new information. If
information is furnished to the Agency confirming the analytical
procedures the study can be used to fulfill the data requirement.
The study reports that trifluralin degraded with a reported
half-life of 41 days when exposed to a light source on sandy loam soil.
The half-life of dark control samples of trifluralin was reported to be 66
days. Two degradates, 2,6-dinitro-N-propyl-4
-trifluoromethylbenzenamine, and 2-ethyl-7nitro-5-trifluoromethyl-
benzimidazole~3-oxide, were identified in the light exposed samples at
41
-------
maximum concentrations of 6.0% and 7.1% of applied radioactivity in
the soil extract, respectively. Unidentified residues made up a
maximum of <9.6% of soil extract at 29.8-day following treatment. At
29.8 days following treatment, 11.2% of the applied radioactivity was
not extracted. Also, carbon dioxide was reported to reach 5.79% of
applied radioactivity in the exposed samples and 0% for the dark control
samples during the testing period. The Agency is currently reviewing
information submitted by the registrant to fulfill this requirement
(MRID 40597801, 40751301).
Aerobic Soil Metabolism; The aerobic soil metabolism study is
scientifically valid and can be used for supplemental data but cannot be
used to fulfill the data requirement. A complete environmental fate
assessment of the degradation of trifluralin under aerobic conditions
cannot be made at this time for the following reason: Degradates
present in the organic extracts at up to 7.6% of the applied (0.119 ppm)
and in the aqueous extracts at up to 6.9% of the applied (0.108 ppm)
were not characterized.
Trifluralin degraded with registrant-calculated half-lives of 189,
201, and 116 days in sandy loam, clay loam, and loam soils,
respectively, when incubated aerobically in the dark at 22°C for 364
days. Seven degradates were identified. With maximum percentages of
applied radioactivity in the test samples, the seven degradates are:
i
1) a,a,a-trifluoro-2,6-dinitro-N-propyl-p,-toluidine
2) a,a,a-trifluoro-5-nitro-4-propyl-toluene- 3,4-diamine
3) 2-ethyl-7-nitro-l -propyl-5-(trifluorom ethyl)
benzimidazole-3-oxide
4) 2-ethyl-7-nitro-l-propyl-5-(trifluoromethyl) benzimidazole
5) 2-ethyl-7-nitro-5-(trifluoromethyl)benzimidazole
6) a,a,oc-trifluoro-2,6-dinitro-p-cresol
7) 2,2'azoxybis(a,a,a-trifluoro-6-nitro-N-propyl-p- toluidine
These degradates were identified in test samples at maximum
concentrations (% applied radioactivity) 2.8 to 4.6%, 1.5 to 2.1%, 0.1 to
0.3%, 0.5 to 1.0%, 2.1 to 2.6%, 0.1 to 2.7%, and 0.8 to 3.0%. During
the testing period of about one year trifluralin parent declined to less
than 25% of applied radioactivity in all soils. At the same time volatile
and unextractable residues increased to 21.7% and about 45% of
applied radioactivity. The registrant has submitted degradate
information that is currently under Agency review (MRID 41240501).
42
-------
Anaerobic Soil Metabolism; The anaerobic soil metabolism study is
scientifically valid and can be used as supplemental data. The data
cannot be used to fulfill the guideline requirement but may be
upgradable. A complete assessment of trifluralin degradation under
anaerobic conditions cannot be made at this time because important
degradates were not identified: Degradates were not characterized that
were present in organic extracts at up to 6.1% of applied radioactivity
(0.099 ppm) and in aqueous extracts at up to 12.1% of applied (0.182
ppm).
Based on the study available, trifluralin degraded with
registrant-calculated half-lives of 25-59 days in sandy loam, loam, and
clay loam soils incubated anaerobically in the dark at 22°C for 60 days
following an aerobic incubation period of 30 days. The major
degradates identified were:
1) a,a,a-trifluoro-5-nitro-N4,N4-dipropyl-toluene- 3,4-diamine
(which reached a maximum concentration of 5.4% and 13.2% of
the applied radioactivity in the sandy loam soil and clay loam
soil, respectively, at Day 60 following flooding, and 11.6% in
the loam soil at Day 30 following flooding);
2) 7-amino-2-ethyl-l-propyl-5-(trifluorom ethyl) benzimidazole
(which reached 7.3% in the sandy loam soil and 8.3% in the
loam and clay loam soils at Day 60 following flooding);
3) a,a,a-trifluoro-N4,N4-dipropyltoluene-3,4,5-triamine (which
reached 0.3% in the sandy loam soil, 4.1% in the loam soil, and
2.6% in the clay loam soil).
Four other degradates identified were:
1) a,a,a-trifluoro-2,6-dinitro-N-propyl-p-toluidine;
2) a,a,a-trifluoro-5-nitro-N4-propyl-toluene-3,4-diamine;
3) 2-ethyl-7-nitro-l- propyl-5-(trifluoromethyl) benzimidazole;
4) 2,2'-azoxybis (a,a,a-trifluoro-6-nitro-N-propyl- p-toluidine)
each present at concentrations up to 2.1% of the initial radioactivity.
The following three degradates:
1) 2-ethyl-7-nitro-1 -propy 1-5 -(trifluoromethy 1);
2) benzimidazole-3-oxide;
3) 7-amino-2-ethyl-5-(trifluoromethyl)ben2.imidazole;
43
-------
were each present at up to 1% of the initial radioactivity.
Uncharacterized degradates in the organic extracts were at maximum
concentrations of 6.1% (0.099 ppm) of the initial radioactivity in the
sandy loam soil, 6.2% (0.093 ppm) in the loam soil, and 6.3% (0.090
ppm) in the clay loam soil. Uncharacterized degradates in the aqueous
extracts were maximums of 6.4% (0.104 ppm) of applied radioactivity
in the sandy loam soil, 12.1% (0.182 ppm) in the loam soil, and 9.6%
(0.138 ppm) in the clay loam soil. An increase of unextractable
trifiuralin residues (9.4 to 60%) indicated that binding of residues to soil
organic matter is the major route of anaerobic dissipation for trifiuralin.
The registrant has submitted degradate information that is currently
under Agency review (MRID 41240502).
(2) Mobility
Leaching and Adsorption-Pesorption: The mobility study, an unaged
batch equilibrium and aged column study, is scientifically valid and can
be used as supplemental data. It cannot be used to fulfill the data
requirement. Degradates that were detected in the soil segments extracts
and the leachate were not quantified and characterized, as needed to
predict the leaching of trifiuralin residues.
Unaged trifiuralin appears not to be mobile in sandy loam, loam,
and clay loam soils (Freundlich Kads, values of 54.8-155.6). However,
aged trifiuralin residues appear to be slightly mobile in columns of sand
and loam soils: About 90% of the applied radioactivity remained in the
upper 6 cm; 0.65-2.57% leached from the column. The degradates
identified were:
1) a,a,a-trifluoro-2,6-dinitro-N-propyl-toluidine (TR-2) (present at
3.01-3.05%. of the extracted radioactivity);
2) 2-ethyl-7-nitro-1 -propyl-5-(trifluoromethyl)-b enzimidazole
(present at 0.77-0.87% of extracted radioactivity);
3) 2,2'-azoxybis(a,a,a-trifluoro-6-mtro-N-propyl-p- toluidine) ,
(present at 0.38-0.40% of extracted radioactivity).
Degradates remaining at the TLC origin were 0.88 to 1.31% of
the extracted radioactivity. Also, radioactivity in other TLC zones
ranged from 0.01 to 0.54% of extracted radioactivity. Uncharacterized
residues in the aqueous extract averaged 0.76% of the applied
radioactivity with unextracted residues averaging 6.79% of the applied
radioactivity. Volatile residues extracted from the charcoal trap
averaged 3.40% of the applied radioactivity. The extracted radioactivity
44
-------
in the charcoal trap was identified as essentially all trifluralin with some
TR-2, and residues remaining at the TLC origin. The registrant has
responded to the study deficiencies and this submission is currently
under Agency review (MRID 40673501).
Laboratory Volatility; Three laboratory volatility studies were
submitted and provide supplemental data. They cannot be used to fulfill
the data requirement. These data were taken from published articles and
were not originally designed to satisfy Subdivision N data requirements.
Therefore, it is difficult to draw conclusions needed for an
environmental fate assessment. However, published laboratory and
field volatility data submitted (MRID 40673601A-G) do indicate the
following:
1) Volatility may be a major route of dissipation for trifluralin
above the soil surface.
2) Trifluralin appears to volatilize (25 to 60% of applied in 11
days).
3) Data are needed to determine relative rate of dissipation due to
volatility in relation to other routes of dissipation.
In the data submitted, the concentration of trifluralin in air and
soil was not reported. Also, application rate and material balances could
not be confirmed, and the concentration of trifluralin residues in the air
could not be related to the concentration of trifluralin residues in the
soil. Furthermore, the study was terminated before the pattern of
decline of the test substance was established. The registrant has
committed to conduct a new laboratory field volatility study (MRID
40673601A, 40673601B, 40673601C).
Field Volatility: Four field volatility studies were submitted and
provide supplemental data. They cannot be used to fulfill the data
requirement.
These data were taken from published articles and were not
originally designed to satisfy Sub division N data requirements.
Therefore, it is difficult to draw the conclusions needed for an
environmental fate assessment. However, published volatility data
submitted do indicate the following:
1) Volatility may be a major route of dissipation for trifluralin
above the soil surface.
45
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2) Trifluralin appears to volatilize: 25% to 60% of applied
trifluralin volatilizes in 11 days).
3) Laboratory volatility data are needed to determine the
contribution of volatilization to dissipation, relative to other
dissipation mechanisms.
4) No further field volatility data are needed until evaluation of
acceptable laboratory volatility data are completed.
In the data submitted the concentration of trifluralin in the soil
immediately following treatment was not reported. Therefore, the
application rate, was not confirmed and the concentration of trifluralin in
the air could not be related to the amount of trifluralin in the soil.
Furthermore, the study was terminated before the pattern of decline of
the test substance was established. The registrant has requested that the
need for a new study be determined upon receipt and review of the
laboratory volatility study (MRID 4067360ID, 4067360 IE, 4067360 IF,
40673 601G).
(3) Accumulation
Bioaccumiilation in Fish; A single study submitted was determined to
be scientifically valid and to provide supplemental information. That
study cannot be used to fulfill the data requirement. Accumulation and
depuration in fish cannot be fully assessed because radioactive residues
in the fish tissues were not completely characterized. Radioactivity
attributed to a total of 10 metabolites at a maximum of 0.804 ppm was
not identified; up to 1.273 ppm was described only as polar
radioactivity. Also, up to 1.8% of the total radioactivity in the aqueous
phase of the tissue extracts was not characterized. Trifluralin residues
accumulated in bluegill sunfish exposed to 0.0059 ppm of trifluralin,
with maximum mean bioconcentration factors of 2041x, 9586x, and
5674x for edible, nonedible, and whole fish tissues, respectively.
Depuration occurred with 86.34-88.01% of the [14C]residues eliminated
from the fish tissues after 14 days of exposure to pesticide free water.
The registrant has responded to the study deficiencies. This submission
is currently under Agency review (MRID 40673801).
(4) Field Dissipation
Terrestrial Field Dissipation: The submitted studies of terrestrial field
dissipation are scientifically valid and can be used as supplemental data.
However, they cannot be used to fulfill the data requirement because
degradates identified in laboratory data were not analyzed for in field
46
-------
samples, and the degradation pathway of trifluralin in the field could not
be determined from this study.
In order to fulfill the data requirement, acceptable data must be
submitted for two sites treated at the maximum registered application
rate for each trifluralin formulation type.
Granular trifluralin dissipated with a reported half-life of 49 days
in the top 6 inches of soil when applied to loamy sand soil in California.
Pretreatment sample analysis indicated there were low levels (0.07-0.16
ppm) of trifluralin present at depths less than 6 inches. Immediately
following treatment, concentrations ranged from 1.30 to 6.30 ppm and
from 1.80 to 5.00 ppm for applications 1 and 2, respectively. By days
14 and 42 following treatment the average recovery was 1.14 ppm
(range of 0.88-1.30 ppm) and 0.74 ppm (range of 0.38-1.90),
respectively. With the exception of one sample, trifluralin was not
detected at depths greater than 6 inches (MRID 41781901).
Trifluralin (EC formulations) dissipated with reported half-lives
of 149 days from California loam soil and 93 days from Alabama clay
soil. Immediately following treatment, the recoveries on 8 samples
ranged from 2.10 to 6.70 ppm and from 1.40 to 2.90 ppm at depths to 6
inches for the CA and AL sites, respectively. By termination of the
study (Day 494 following treatment for C A site and day 482 following
treatment for AL site) the recovery of applied material had declined to
0.22 and 0.04 ppm, respectively. Trifluralin did not appear to leach to
below 6 inches depth. However, one sample at 24 to 30 inches depth
did contain trifluralin at 0.06 ppm, 494 days following treatment at the
California site (MRID 41661101).
Emulsifiable concentrate trifluralin formulations were reported to
dissipate with a half-life ranging from 29 to 35 days when applied to
coarse (sandy loam soil at Shellman, GA site) and fine (silty clay loam
soil at Mansfield, EL site) soils, respectively. However, granular
trifluralin formulation was reported to dissipate with a half-life ranging
from 15-to 86 days when applied to sandy loam soil in Shellman, GA.
These half-lives were calculated from nonlinear dissipation curves..
Furthermore, since trifluralin was not discernible in soil segments below
the top 6 inches of soil, trifluralin did not demonstrate any leaching
potential.
Mean recoveries immediately following treatment for the
emulsifiable concentrate at the Georgia and Illinois sites were 0.94 ppm
47
-------
c.
(132% of applied) and 0.99 ppm (200% of applied) at depths less than 6
inches, respectively. For the granular formulation the mean recoveries
immediate following treatment at the Georgia and Illinois sites were
0.85 ppm (113% of applied) and 0.67 ppm (134% of applied),
respectively. By termination of study, the mean recoveries for the
emulsifiable concentrate were 0.04 ppm at 398 following treatment at
the Illinois site and 0.09 ppm at Day 193 following treatment at the
Georgia sites. For the granular formulation, at termination of study the
mean recoveries were 0.04 ppm (Day 573 posttreatment) and 0.10 ppm
(Day 549 posttreatment) for the Illinois and Georgia sites, respectively.
There was an increase in the mean at Day 7 posttreatment at the Georgia
site for the emulsifiable concentrate formulation (1.91 ppm which is
400% of applied) and at the Illinois site for the granular formulation
(1.01 ppm which is 135% of applied)(MRID 42309101).
(5) Spray Drift
No studies have been submitted to the Agency for spray drift
droplet size (201-1) or field drift (202-1). These studies are held in
reserve pending the results of work currently being conducted by the
Spray Drift Task Force. Registrants who are not members of Task
Force or do not have the permission to cite Task Force data will have to
independently develop these data.
Water Resources
(1) Ground Water
Trifluralin has a very low propensity to leach in the vast majority
of soils because of its strong adsorption to soil colloids and organic
matter. Trifluralin is, however, a persistent pesticide with an aerobic
soil metabolism half-life of 116-201 days in guideline studies (other
studies have been published in the technical literature; half-lives have
generally been in the same range, although it is a little less persistent in
some soils). Its field dissipation half-life has been reported as low as 29
days and as high as 149 days in guideline studies. Published field
dissipation half-lives range from 60 to 132 days (Wauchope et al.,
1992). Trifluralin is very immobile with Kd values ranging from 18 to
156 L/kg in four test soils. The average Koc value for trifluralin has
been estimated to be anywhere from 1200 to 13700 (Wauchope et al.,
1992). Considering the nature of the chemical; i.e., often persistent for
many months but very immobile in nearly all if not all soils, trifluralin
48
-------
would only be expected to affect ground water under special
circumstances.
Pesticides in Ground Water Data Base indicates that for the years
1971-1991 trifluralin has been detected in well water in ten states at
concentrations of 0.01 to 14.89 ppb. The states for which detections are
indicated in the DataBase are IA, IL, IN, MD, MO, MS, ND, NE, SD,
and VA. Several considerations call into question the value or
significance of the detections for purposes of risk assessment. The
detections were for the most part unconfirmed analytically, from very
shallow ground water, from point sources, or at very low
concentrations. No ground water label advisory or management plan is
recommended for trifluralin at this time.
Evaluation of Ground Water Residue Data; Trifluralin has been
detected at from 0.002 to 14.9 ppb in 59 of 5590 well water samples
from 21 states (Hoheisel et al., 1992 and 12/23/93 errata). The high
detection of 14.9 ppb, in Iowa, was traced to an incident of direct spill
of the formulated product into a well (Kross et al., 1990).
By far the largest numbers of wells with trifluralin detections
were from Illinois (26 of 542 wells), Missouri (10 of 324 wells), and
Virginia (9 of 138 wells). A description of the studies with most of the
detections follows.
Illinois Data; About eighteen (the exact number cannot be determined
from the original study report) of the wells with detections in Illinois in
the PGWDB were from a single study covering an area of about 42
square miles adjacent to the Illinois River in Mason county (McKenna
et al., 1988). This study evaluated pesticide concentrations in shallow
(usually 3 to 7 meters or 10 to 23 feet) monitoring wells plus existing
wells (usually domestic drinking water wells 7 to 12 meters in depth)
finished in a surficial aquifer overlain by sandy soils.
The detection limit for trifluralin in the McKenna et al. study was
0.004 ppb, which is extremely low for a compound which is normally
applied to the soil surface at about 0.5 to 1 Ib ai/A. The maximum
apparent trifluralin concentration among 49 samples with detectable
levels was 0.14 ppb. The analytical method utilized gas
chromatography with electron capture detection (GC-ECD), confirming
residues only by running the GC analyses with two different separation
columns. This is inadequate because GC-ECD is a very non-specific
detection method which is sensitive to a vast number of halogenated
49
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organic compounds. Confirmation of these sub-ppb residue levels
should have been performed with GC-mass spectrometry. Apparent
detections were all below 0.2 ppb except for a well in Gallatin county
which had up to 1.7 ppb.
Trifluralin was "detected" in 8 of 25 wells set up for monitoring
vulnerable ground water in four "high risk regions" of Illinois (Felsot,
1988). These wells were all in locations with very sandy soils. These
data are of even poorer quality than from the other study with apparent
trifluralin detections, with no attempt at all to confirm the identity of
peaks eluted from the sample with the GC electron capture detection
method used.
Missouri Data; Apparently all of the detections in Missouri were from
a single study, although the author's written report clearly identifies only
eight different wells with trifluralin detections (Mesko and Carlson,
1988). Evaluation of the reliability of these data is impossible because
the report does not describe the analytical methods used. Some samples
were split and analyzed by two or more separate facilities, however, the
authors note that detections by one laboratory were sometimes not
confirmed in the other laboratory that analyzed a portion of the same
sample (details of these quality control efforts were not provided). The
study area was the Mississippi alluvial plain in several counties in
extreme southeastern Missouri. Most of the wells were sampled from
shallow alluvial aquifers. Trifluralin detections were in the range of
0.006 to 0.14 ppb.
Virginia Data: Eight of the nine trifluralin detections reported in the
PGWDB were from a single study of a 3700 acre watershed in
Westmoreland County. Little background information is available on
these detections. Pesticide detections were apparently confirmed with
two different GC detection systems (but not by mass spectrometry).
Some pesticides not normally analyzable at environmental
concentrations with the instrumentation used were included as analytes,
the authors did not explain how this was done. Most of the wells
sampled from were monitoring wells installed specifically for the
purposes of this study. A wide variety of pesticides were found in many
of these wells, often at concentrations much higher than for trifluralin.
Other pesticides with relatively low leaching potential were also
detected in ground water, including disulfoton (Koc = 600, ilA = 30
days), paraquat (Koc = 1000000, tV2 = 1000 days), malathion (Koc =
1800, tY2 = 1 day), linuron (Koc = 400, tYz = 60 days), carbaryl (Koc =
200, lYz = 10 days), fenvalerate (Koc = 5300, tl/2 = 35 days), and
50
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peirmethrin (Koc = 100000, tY2 = 30 days) (the values for Koc and tlA are
taken from Wauchope etal., 1991; values from guideline studies are
similar to these).
Summary of Ground Water Monitoring Data: Trifiuralin appears to
only very rarely contaminate ground water except for shallow and
extremely vulnerable surficial aquifers which would be contaminated by
virtually any pesticide that was used in the area. Extremely sensitive
analytical methodology is available for analysis of trifluralin residues in
ground water (usually down to a few parts per trillion), this is more than
adequate considering the application rates used and the level of the
lifetime health advisory for trifluralin. It appears unlikely that trifluralin
use would rarely if ever result in ground water contamination at levels
approaching a few tenths of a ppb, except for extremely vulnerable
areas.
(2) Surface Water
Trifluralin can contaminate surface water by spray drift. Also,
under some circumstances trifluralin may contaminate surface water by
runoff, mostly via transport of contaminated sediment. Contamination
of drinking water is not expected to result in a substantial risk to
humans: The limited monitoring data for surface water as well as the
results of Tier 2 modelling suggest that annual average concentrations
are not likely to exceed the lifetime health advisory levels, and that
peak/short term averages are not likely to exceed 1 day and 10 day
health advisory levels. Also, most primary treatment procedures applied
to surface water are likely to be effective in removing trifluralin,
particularly given the relatively high soil/water partitioning of the
chemical.
Substantial trifluralin could be available for runoff to surface
waters for several weeks to months following application, based on
measurements of aerobic soil metabolism (half-life 115 days),
photodegradation on soil (half-life 41 days), and terrestrial field
dissipation (half-life 15 to 149 days). Under some conditions,
volatilization from soil may contribute significantly to the overall
dissipation rate.
The relatively high soil/water partitioning of trifluralin
(SCS/ARS database Koc of 8000; Kads = 18-19 for sandy soil and 53-156
for finer soils) indicates that the concentration of trifluralin adsorbed to
eroding soil will be 1 to over 2 orders of magnitude greater than the
51
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dissolved concentration in runoff water. However, the sediment yield
off many fields varies anywhere from 1 to > 3 orders of magnitude less
than the mass equivalent of the runoff volume. Therefore, the mass
percentage of trifluralin runoff occurring via dissolution in runoff water
may be somewhat comparable to or sometimes greater than that
occurring via adsorption to eroding soil in cases where the sediment
yield is 1 to > 3 orders of magnitude less than the runoff volume.
Trifluralin is susceptible to direct aqueous photolysis (half-life
8.9 hours) and to volatilization (Henry's Law constant = 1.6 x 10"4
atnvm3/mol) which should limit its persistence in the water column of
well mixed, shallow surface water.- However, its resistance to abiotic
hydrolysis, only moderate susceptibility to aerobic metabolism and only
slightly greater susceptibility to anaerobic metabolism (anaerobic soil
metabolism half-life of 25-59 days) should make it more persistent in
other types of surface water, particularly those with relatively long
hydrological residence times. Its relatively high soil/water partitioning
indicates that the concentration of trifluralin adsorbed to suspended and
bottom sediment will be substantially greater than its dissolved
concentration in the water column. Surface waters will be adsorbed to
suspended and bottom sediment as opposed to dissolved in the water
column.
Trifluralin and/or its major degradates appear to have some
potential for bioconcentratioh as evidenced by total 14C residue BCF
factors of 2040X to 9590X.
There is insufficient data on the several major degradates (see
fate section) of trifluralin to adequately assess their persistence and
mobility. However, they appear to have similar persistence and
mobility to trifluralin in the environment.
Surface Water Monitoring and Detection; The State of Illinois
(Moyer and Cross 1990) sampled 30 surface water sites for pesticides at
various times from October 1985 through October 1988. Substantial
use in Illinois was a criterion for pesticides being included in the
analyses. Total trifluralin (dissolved plus adsorbed to suspended
sediment) was detected in 18 of 580 samples collected (detection limit
0.01 ug/L) . The 18 detections were from 13 of the 30 sites sampled.
Concentrations ranged from 0.015 to 0.73 ug/L. Three of the 18
detections were at concentrations greater than 0.2 ug/L (0.23, 0.54, and
0.73 ug/L).
52
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The USGS (Squillace and Engberg 1985) sampled 7 surface
water sites in the Cedar River Basin (Iowa) from May 1984 through
November 1895, Samples were collected monthly except in June 1984
when they were collected bimonthly. Total trifluralin and dissolved
trifluralin were not detected in any of the samples collected from any of
the 6 sites (detection limits 0.05 or 0.10 ug/L).
The USGS sampled 7 widely spread locations within the
Mississippi Basin at frequent intervals from April 1991 to April 1992
(Goolsby and Battaglin, 1993). Dissolved trifluralin was detected at
concentrations between approximately 0.003 and 0.03 ug/L in 81 of the
316 samples collected (level of quantification approximately 0.003
ug/L). Trifluralin was detected at all 7 locations with percentage
detections ranging from 7% in the White River to 42% in the
Mississippi River at Thebes IL and 47% in the Missouri River at
Hermann MO.
Illinois sampled 128 to 129 surface water source supply systems
in 1991 and 1992 (Taylor 1992). In 1991, one sample was collected in
April-July from each system, and an additional sample was collected in
September from some of the systems. Trifluralin was detected in one or
more samples collected from 30 of the 129 systems sampled at
concentrations ranging from 0.02 ug/L to 0.2 ug/L. In 1992, one sample
was collected in April to June from each of 128 systems. Trifluralin
w&s detected in samples collected from 7 of the 128 samples at
concentrations ranging from 0.05 ug/L to 0.36 ug/L. The detection limit
was not provided.
Tier 2 Surface Water Modelling; The Agency has calculated Tier 2
estimated environmental concentrations (EECs) for assessing risk to
aquatic organisms. EECs assume a body of water with 1 ha surface area
and depth 2 m draining a 10 ha file of sugarcane or soybeans. Sites
were a Louisiana Commerce silt loam site (thought to represent a
reasonable high runoff site for sugarcane) and an Illinois Hosmer silt
loam site (thought to represent a reasonable high runoff site for
soybeans). For each site the concentrations were simulated over 36
years. Assuming conventional tillage, two ground applications of 4 Ib
ai/acre at 6 month intervals with 3 inch incorporation, and 1% ground
application spray drift, estimated 1 in 10 year concentrations for the
Louisiana sugarcane site were 3.44 ug/L (initial), 2.06 ug/L (96 hour
average), 0.78 ug/L (21 day average), 0.49 ug/L (60 day average), and
0.39 ug/L (90 day average). Based on the same assumptions except
assuming a single application at 2 Ib ai/acre, estimated 1 in 10 year
53
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concentrations for the Illinois soybean site were 2.89 ug/L (initial), 2.01
ug/L (96 hour average), 0.81 ug/L (21 day average), 0.41 ug/L (60 day
average), and 0.31 ug/L (90 day average).
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. 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),
-LCSO (fish and birds), 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), 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 below along with the corresponding LOCs.
54
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Levels of Concern (LOG) and Associated Risk Presumption
Mammals and Birds
IF THE
acute RQ>
acute RQ>
acute RQ>
chronic RQ>
Fish and Aquatic Invertebrates
IF THE .
acute RQ>
acute RQ>
acute RQ>
chronic RQ>
Plants
IF THE
RQ>
RQ>
LOG
0.5
0.2
0.1
1
LOG
0.5
0.1
0.05
1
LOG
1
1
PRESUMPTION
High acute risk
Risk that may be mitigated
through restricted use
Endangered species may be
affected acutely
Chronic risk, endangered
species may be affected
chronically,
PRESUMPTION
High acute risk
Risk that may be mitigated
through restricted use
Endangered species may be
affected acutely
Chronic risk, endangered
species may be affected
chronically
PRESUMPTION
High risk
Endangered plants may be
affected
Plants do not have separate criteria for restricted use or chronic effects.
(1) Exposure and Risk to Nontarget Terrestrial Animals
Birds: Residues found on dietary food items following trifluralin
application may be compared to acute LC50 values to predict hazard.
Chronic hazard is predicted by comparing the residues to either the
NOEC or the LOEC from a valid avian reproduction study. In this case,
the NOEC used to calculate the RQ is from unreviewed data; however,
the studies appear to be scientifically sound based on cursory review.
Although it is not expected, both the NOEC and the LOEC are subject
to change once the studies have been reviewed comprehensively.
55
-------
Therefore, the RQs may also be subject to change once these studies
have been reviewed and validated.
The maximum concentration of residues of trifluralin and the
corresponding risk quotients which may be expected to occur on
selected avian dietary food items following a single application rate of
2.0 Ib. a.i./A (maximum application rate for all crops except sugarcane
in Hawaii) and 4.0 Ib a.i./A (maximum application rate on sugarcane in
Hawaii) are provided in the table below:
- **"" M , -
« ^BlrtBjy Concentrations to wri} and JUsfeQwotleirfa for BtriJs ' i
Food Items
Range Grasses (short)
Fniit/Vcgctable Leaves (other
than legumes)
Forage Legumes and Insects
Seeds
Fruits
EEC for 2.0 Ib
a.i./A
480 ppm
250
116
24
14
RQ
Acute
0.096
0.05
0.023
0.005
0.003
Chronic
1.06
0.55
0.26
0.05
0.03
EEC for 4.0 Ib
a.l./A
960 ppm
500
232
48
28
RQ
Acute
0.192
0.1
0.05
0.009
0.006
Chronic
2.12
1.1
0.51
0.11
0.06
The LOG for endangered species has been exceeded on range
grasses and for fruit and vegetable leaves for the 4.0 Ib a.i./A label rate.
Therefore, the use of trifluralin may cause adverse acute effects to
endangered and threatened avian species.
The chronic LOG has been exceeded on range grasses for both
maximum labeled rates, also on fruit and vegetable leaves for the 4.0 Ib
a.i./A label rate. Therefore, use of trifluralin may affect reproduction in
birds adversely.
Mammals; Small mammal exposure is addressed using acute oral LD50
values converted to estimate an LC50 value for dietary exposure. The
estimated LC50 is derived using the following formula;
LD50 x body weight (g)
50 food cons, per day (g)
56
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* '•t^, *'' Swau.Mantmaf¥todC«nsttittjjS«i»
-.' > ' '•• '' ' •• {Baieaona&tDj.s* 2,000 mg/kjt} ' ' '""
Small Mammal
Meadow vole
Adult field mouse
Least shrew
Body Weight in
Grams
46
13
5
% of Weight Eaten
Per Day
61 %
16%
110%
Food Consumed Per Day in
Grams
28.1 gms
2.1 gms
5.5 gms
Estimated LQ, Per
Day
3,274 ppm
12,381 ppm
1,818 ppm
The above table is based on information contained inPrinciples of Mammologybv D. E. Davis and F. Golly, published by Reinhold Corporation,
1963'.
The estimated LC50 is then compared to the EECs calculated as
for birds (section (a) .above) to calculate a risk quotient (EEC/LC50). The
table below indicates the risk quotients for each of the following
application rates:
'••''' " „, , , "'-vf, ' « ••';'//{" ' '"t ' '" '•
,,,,'/' '',,, ' „ ' J0fe*ary:RTskQuttttenteM'MaroiHato
' " " ' ^ased0tt.Dl6lttrylR.(J«:1SBCjrfisttm*t«itG^:
Small Mammal
Meadow vole consuming range grasses
Adult field mouse consuming seeds
Least shrew consuming forage and insects
RQ
Application Rates in Ib. a.i./A
2.0
0.15
0.002
.0.06
4.0
0.29
0.004
0.13
The LOG for endangered species has been exceeded for the
meadow vole consuming range grasses at the 2.0 Ib application rate and
the least shrew consuming forage and insects at the 4.0 Ib application
rate. The LOG for restricted use has also been exceeded for the meadow
vole at.the 4.0 Ib application rate. This would indicate that small
mammals, including endangered and threatened species, feeding on
grasses, insects or seeds could be adversely affected by the use of
trifluralin.
Insects: Trifluralin is practically nontoxic to honey bees. Adverse
impact to honey bees is not expected from the use of trifluralin.
(2) Exposure and Risk to Nontarget Aquatic Animals
Expected Aquatic Concentrations: Trifluralin displays very high
toxicity to most aquatic organisms tested to date. A refined (Tier 2)
EEC has been calculated for ground application to soybeans and
57
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sugarcane. This EEC is determined using environmental fate and
transport computer models. The Pesticide Root Zone Model (PRZM2)
was used to simulate pesticides in field runoff and the Exposure
Analysis Modeling System (EXAMS II) to simulate pesticide fate and
transport in an aquatic environment. The soils selected for modeling are
class C (moderately high runoff potential) and represents high exposure
but reasonable sites. Use sites simulated were a Louisiana Commerce
silt loam site thought to represent a reasonable high runoff site for
sugarcane and an Illinois Hosmer silt loam site thought to represent a
reasonable high runoff site for soybeans. The average amounts of
rainfall were 58 and 33 inches per year for Louisiana and Illinois sites,
respectively. The application rate assumed is the highest recommended
label rate. The EECs represent a body of water with surface area 1 ha
and depth 2 m, receiving runoff from a 10 ha field of sugarcane or
soybeans. It was assumed that 1% of applied trifluralin reached the
water by spray drift.
Results of the simulation are displayed below. The 1 in 10 year
maximum initial, 96 hour acute, 21 day chronic, maximum 60 day and
maximum 90 day average dissolved trifluralin concentrations are also
displayed.
" •'••''•:•• '-•>- '<
Estimated Environmental eontccntralians (EECs) jfor Nanfewget Aquatic Animal Bisk
Crop
Sugarcane
Soybeans
Application
Method
Ground
Ground
Application Rate in Ib a.i./A
(# of applications)
2.0 (2) (total application ,
equals 4.0 Ib a.i./A)
2.0(1)
Maximum
Initial EEC
(Ppb)
5.69
7.01
4- day
EEC
(Ppb)
2.75
3.15
21-day
EEC
(Ppb)
0.89
0.91
60-day
EEC
(ppb)
0.57
0.50
90-day
EEC
(Ppb)
0.48
0.39
The total annual trifluralin losses (as % of applied) were 2.43%
for soybeans and 1.51% for sugarcane. Part of this difference is due to
dissimilarities between the sites in soil characteristics, environmental
conditions, and agronomic practices. These results also indicate that
most of trifluralin loss from both sites was due to spray drift and runoff.
Losses due to the assumed spray drift played a major role and had
greater impact on the fractional loss for Louisiana sugarcane than for
Illinois soybeans (64.7% versus 40.3%). These results also indicate that
trifluralin dissolved in runoff water accounted for 26.7% of the total
trifluralin loss from the Louisiana sugarcane site, and 54.6% from the
Illinois soybean site. Trifluralin bound to eroding soil contributed much
less to the overall trifluralin loss than spray drift or trifluralin dissolved
58
-------
in runoff water. These results indicate that mitigation practices that
reduce spray drift and runoff volume will be effective in reducing
trifluralin transport to aquatic environments.
Freshwater Fish: The following table lists the acute and chronic risk
quotients for freshwater fish:
RlskC
Crop/application rate
Sugarcane/2.0 Ib a.i./A applied two times for a total
of 4.0 Ib a.i./A
Soybeans/2.0 Ib a.i./A
!w>tjenfe(HQ) for Freshwater Fish
Species
Bluegill
Rainbow trout
Fathead minnow
Bluegill
Rainbow trout
Fathead minnow
Acute RQ (96-hr)
0.05
0.07
0.03
0.05
0.08
0.03
Chronic RQ (60-day)
0.5
0.3
0.4
0.3
The LOGs have not been exceeded. However, a sheepshead
minnow study (Couch etal., 1979) related occurrence of vertebral
dysplasia in the fish to low level exposures to trifluralin. A subsequent
field study showed that trifluralin will transport to receiving waters and
is bioavailable to aquatic organisms. Trifluralin may also contribute at
non-detectable residue levels with other environmental or chemical
influences to increase evidences of vertebral anomalies in finfish.
Therefore, based on these findings, it is likely that freshwater finfish
may be adversely affected from the use of trifluralin.
It is important to note that the estimated environmental
concentration (EEC), on which the LOG determination is based,
represents only the pesticide dissolved in the water column and does not
take into account pesticide which may be adsorbed to suspended and
bottom sediment. Trifluralin's relatively high soil/water partitioning
indicates that the concentration of trifluralin adsorbed to suspended and
bottom sediment will be substantially greater than its dissolved
concentration in the water column. Also, trifluralin has a relatively high
tendency to bioaccumulate in fish (bioconcentration factors of 204Ix to
9586x). This, along with the fact that the fish will be exposed to
trifluralin while scavenging or foraging, is also evidence that finfish
may be adversely affected from exposure to trifluralin.
Freshwater Invertebrates: The following table lists the acute and
chronic risk quotients for freshwater invertebrates:
59
-------
JUsfeQiK>tieiilsORO>foi-Pt«*wat«rInv«iieh rates
Crop/application rate
Sugarcane/2.0 Ib a.i./A applied two times for a total of 4.0 Ib
a.i./A
Soybeans/2.0 Ib a.i./A
Species
Daphnia magna
Daphnia magna
Acute RQ (96-hr)
0.005
0.006
Chronic RQ (2 1-day)
0.2
0.2
The LOCs have not been exceeded. Freshwater invertebrates
may not be adversely affected by the use of trifluralin.
Estuarine and Marine Animals: The following table lists the acute
and chronic risk quotients for estuarine and marine organisms:
*< * ;,//,/"'«>" , ,
*, RfsfeQuoitunfeifRO'JforEstwariwBattdMariReOrsanfeBasf- , '.:... a.
Crop/application rate
Sugarcanc/2.0 Ib a.i./A applied two times for atotal of 4.0 Ib a.i./A
Soybeans/2.0 Ib a.UA
Species
Sheepshead minnow
Bay mussel
Grass shrimp
Sheepshead minnow
Bay mussel
Grass shrimp
Acute RQ (96-hr)
0.01
0.01
0.004
0.02
0.01
0.005
The LOCs have not been exceeded, however, sheepshead
minnow have been shown to be sensitive to trifluralin in laboratory
studies. In this study (Couch etal., 1979) minnows showed vertebral
dysplasia after exposure to low levels of trifluralin. A subsequent field
study showed that trifluralin will transport to receiving waters and is
bioavailable to aquatic organisms. Trifluralin may also contribute at
non-detectable residue levels with other'environmental or chemical
influences to increase evidences of vertebral anomalies in finfish.
Therefore, based on these findings, it is likely that estuarine and marine
finfish may be adversely affected from the use of trifluralin.
(3) Exposure and Risk to Nontarget Plants
Terrestrial and Semi-Aquatic: Non-target terrestrial plants inhabit
non-aquatic areas. Non-target "semi-aquatic" plants are plants that
usually inhabit low-lying wet areas that may or may not be dry in
certain times of the year. These plants are not obligatory aquatic plants
in that they do not live in a continuously aquatic environment. The
terrestrial and "semi-aquatic" plants are exposed to pesticides from
runoff, drift or volatilization.
60
-------
Runoff exposure is determined from a generic EEC. This runoff
is characterized as a,one acre to one acre sheet runoff to an adjacent
acreage that affects terrestrial plants or a channelized runoff from 10
acres to a low lying area some distance away that affects "semi-aquatic"
and terrestrial plants.
Spray drift exposure is determined by assuming 5% of the
pesticide application will drift over to an adjacent acreage or to a much
longer distance.
The following EECs have been determined for non-target plants
which may be exposed from the application of trifiuralin:
-------
' '' ''RfekOttoacnfefRQiforAqnaficWaate'
Use Site
Soybeans
Sugarcane
Application Rate (Ibs a.i./A)
2.0
4.0
Level of Concern*
1
1
/ f
Aquatic Plants
4-day EEC
(PP1>)
2.75
3.15
RQ
0.4
0.4
* Measure of toxicity: lowest EQ, value (Selenastrum capricornutum) = 7.52 ppb.
The LOCs for aquatic plants, including endangered species, have
not been exceeded for either use site. Therefore, nontarget aquatic
plants are not likely to be affected by direct or indirect exposure to
trifluralin.
(4) Endangered Species
The endangered species LOCs have been exceeded for birds,
mammals, and semi-aquatic plants. Although the LOCs have not been
exceeded for endangered freshwater and marine or estuarine fish, these
species may. be adversely affected based on laboratory and field studies
which revealed vertebral dysplasia after exposure to very low levels of
trifluralin.
The Endangered Species Protection Program will become final
in the future. Limitations in the use of trifluralin will be required to
protect endangered and threatened species, but these limitations have
not been defined and may be formulation specific. The Agency
anticipates that a consultation with the Fish and Wildlife Service will be
conducted in accordance with the species-based priority approach
described in the Program. After completion of consultation, registrants
will be informed if any label modifications are necessary. Such
modifications would most likely consist of the generic label statement
referring pesticide users to use limitations contained in County
Bulletins.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active
ingredient are eligible for reregistration. The Agency has previously identified and required
62
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the submission of the generic (i.e. active ingredient specific) data required to support
reregistration of products containing trifluralin. 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 trifluralin except for products with nongrass forage/fodder/straw/hay
or dill uses. Appendix B identifies the generic data requirements that the Agency reviewed
as part of its determination of reregistration eligibility of trifluralin, 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 trifluralin and to determine that trifluralin can be used without resulting in
unreasonable adverse effects to humans and the environment. The reregistration of
particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data and the data identified in Appendix B. Although the Agency has found
that all uses of trifluralin are eligible for reregistration with the exceptions of nongrass
forage/fodder/straw/hay and dill, 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 trifluralin, if new information comes to the Agency's
attention or if the data requirements for registration (or the guidelines for generating such
data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients trifluralin,
the Agency has sufficient information on the health effects of trifluralin and on its
potential for causing adverse effects in fish and wildlife and the environment.
Therefore, the Agency concludes that products containing trifluralin are eligible for
reregistration for all registered uses except for nongrass fora'ge/fodder/straw/hay and
dill provided the labeling changes and other requirements specified in this document
are implemented
The Agency has determined that trifluralin products, labeled and used as
specified in this Reregistration Eligibility Decision, will not pose unreasonable risks or
adverse effects to humans or the environment.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of trifluralin are eligible for
reregistration with the exceptions of nongrass forage/fodder/straw/hay and dill.
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B. Regulatory Position
The following is a summary of the regulatory positions and rationales for trifluralin.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1.
Tolerance Reassessment
The tolerances listed in 40 CFR §180.207 are for the residues of trifluralin per
se. The "(N)M designation should be deleted from all 40 CFR §180.207 entries.
Adequate Existing Tolerances Under 40 CFR §180.207;
Sufficient data are available to ascertain the adequacy of the established.
tolerances listed in 40 CFR §180.207 (as defined) for the following commodities:
asparagus; barley hay; barley straw; carrots; citrus fruits; corn grain (exc. popcorn);
corn forage; corn fodder; cottonseed; cucurbits; flax seed; grapes; hops; nuts; peanuts;
peppermint, hay; rape seed; saffiower seed; sorghum forage; sorghum fodder;
spearmint, hay; stone fruits; sugarcane; sunflower seed; vegetables, fruiting; wheat,
grain; and wheat, straw. See "Tolerance Reassessment Summary" table for
appropriate commodity definitions of some of these entries.
Tolerances to be Increased:
* Wheat Straw, Barley Straw, and Barley Hay: Available data for wheat
straw and barley straw reflecting treatment at the maximum registered
application rate indicate that the established tolerance for residues of trifluralin
in/on wheat straw, barley straw, and barley hay should be increased to 0.1 ppm.
Tolerances to be Revoked;
* Root Vegetables (exc. carrots) Crop Group: The established crop group
tolerance for the obsolete "root vegetables (exc. carrots)" should be revoked
concomitant with the establishment of: (i) a tolerance for root and tuber
vegetables (exc, carrots) at 0.05 ppm; and (ii) a tolerance for bulb vegetables
group at 0.05 ppm. The available data for radish roots and sugar beet roots will
be translated to chicory roots and turnip roots.
* Leafy Vegetables Crop Group: The established crop group tolerance for the
obsolete "leafy vegetables" should be revoked concomitant with the
establishment of: (i) separate tolerances for celery and endive, each at 0.05
ppm; (ii) a tolerance for leaves of root and tuber vegetables group at 0.05 ppm;
64
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and (iii) a tolerance for Brassica (cole) leafy vegetables group at 0.05 ppm.
The available data for celery will be translated to endive.
* Seed and Pod Vegetables Crop Group: The established crop group tolerance
for the obsolete "seed and pod vegetables" should be revoked concomitant with
the establishment of: (i) a tolerance for legume vegetables (succulent/dried)
group at 0.05 ppm; and (ii) a separate tolerance for okra at 0.05 ppm.
* Grain Crop (except fresh corn and rice grain) Crop Group: The
established crop group tolerance of 0.05 ppm in/on "grain crops (except fresh
corn and rice grain)" is inappropriate because there are no registered uses for
rice, a representative commodity of this group; furthermore, the use directions
are not uniform for the representative commodities of this group. Therefore,
the established crop group tolerance for "grain crops (except fresh corn and rice
grain)" should be revoked concomitant with the establishment of individual
tolerances, each at 0.05 ppm, for barley grain and sorghum grain. .Separate
adequate tolerances of 0.05 ppm already exist for corn and wheat grain. The
available data for field corn grain will be translated to sorghum grain.
* Forage Legumes Crop Group: The established crop group tolerance for
"forage legumes" should be revoked concomitant with the establishment of: (i)
a tolerance for foliage of legume vegetables group at 0.05 ppm; and (ii) a
separate tolerance for alfalfa forage at a level to be determined upon receipt of
required magnitude of the residue data.
* Mung Bean Sprouts: The established tolerance for mung bean sprouts should
be revoked because no registered uses exist for mung bean sprouts per se.
* Upland Cress: The established tolerance for upland cress should be revoked
because no registered uses exist.
* Barley Fodder, Barley Forage, Rape Straw, Flax Straw, and Peanut Hulls:
The Agency no longer considers barley fodder, barley forage, rape straw, flax
straw, and peanut hulls as raw agricultural commodities (Livestock Feeds
Table, 1995). The established tolerances for barley fodder, barley forage, rape
straw, flax straw, and peanut hulls should be revoked.
Data Gaps;
Additional magnitude of the residue data are required before the established
tolerance on alfalfa hay can be reassessed.
65
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Tolerances That Need To Be Proposed Under 40 CFR 8180.207;
* Almond Hulls, Barley Grain, Celery, Okra, Peanut Hay, Sorghum Grain,
and Wheat Forage: Sufficient data are available to recommend the
establishment of a tolerance for residues of trifluralin at 0.05 ppm in/on the
following raw agricultural commodities: almond hulls, barley grain, celery,
okra, peanut hay, sorghum grain, and wheat forage.
* Endive: Based on available celery data which have been translated to endive,
a tolerance for the residues of trifluralin should be established in/on endive. A
tolerance of 0.05 ppm would be appropriate.
* Brassica (Cole) Leafy Vegetables, Bulb Vegetables, Foliage of Legume
Vegetables, Leaves of Root and Tuber Vegetables, and Legume Vegetables
(Dry and Succulent): Sufficient data on representative commodities are
available to recommend the establishment of the following crop group
tolerances for residues of trifluralin at 0.05 ppm: Brassica (cole) leafy
vegetables, bulb vegetables, foliage of legume vegetables, leaves of root and
tuber vegetables, and legume vegetables (dry and succulent).
* Mustard Seed: Sufficient mustard seed data are available to recommend the
establishment of a tolerance for residues of trifluralin at 0.01 ppm in/on
mustard seed.
* Wheat Hay: A tolerance for residues of trifluralin in/on wheat hay must be
established. Based on available barley straw and wheat straw data, a tolerance
of 0.1 ppm would be appropriate.
* Alfalfa Forage: The registrant must propose a tolerance for alfalfa forage once
adequate data have been submitted and evaluated.
* Cotton Gin By-Products, Rape Forage: The Agency currently recognizes
cotton gin by-products as a raw agricultural commodity of cotton and has
determined that label restrictions for rape forage are not appropriate (Livestock
Feeds Table). Therefore, tolerances for cotton gin by-products and rape forage
must be established. The registrant must propose tolerances for cotton gin by-
products and rape forage once adequate data have been submitted and
evaluated.
Tolerances Under 40 CFR S185.5900:
Food additive regulations (FAR) currently exist for residues of trifluralin in
peppermint oil and spearmint oil at 2.0 ppm. The Agency reviewed the mint oil
66
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tolerance in light of recent policies developed concerning "ready-to-eat" processed
foods. The Agency believes that commodities such as mint oils are not "ready-to-eat"
and once diluted, the residues of trifluralin in the "ready-to-eat" food would be lower
than the raw agricultural commodity (RAC) tolerance. Based on this determination,
the existing tolerance is sufficient to cover the residue levels of trifluralin in foods
containing mint oil and a food additive regulation under Section 409 of the FFDCA is
not necessary.
The Agency has therefore proposed to revoke the 2.0 ppm FAR for residues
in/on peppermint oil and spearmint oil set under Section 409 of the FFDCA, and to
withdraw the prior rule revoking these tolerances (60 FR 38781; 7/28/95). However,
even though residues of trifluralin do not concentrate in finished foods containing mint
oil above those found in the RAC, the Agency believes it appropriate to establish a
maximum residue level (MRL) for the residues of trifluralin in mint oils per se for
enforcement purposes. Establishing a MRL for mint oil will ensure that levels in
finished food items do not exceed the RAC tolerance.
To set this tolerance, the Agency has decided to use its general rule-writing
authority under the FFDCA Section 701 to establish Maximum Residue Limits
(MRLs) for mint oils. Section 701 grants the Agency the authority "to promulgate
regulations for the efficient enforcement of this Act." These maximum residue levels
would be set no higher than the levels that could result in the processed food assuming
legal residues in the raw food and that good manufacturing practices were followed.
The MRLs on peppermint and spearmint oil will be established at 2.0 ppm.
Data Gaps;
Because actual concentration factors could not be determined in any of the
submitted studies, additional processing data are required on peppermint and
spearmint oil. It should be noted, however, that the available processing data are
sufficient for the purpose of determining that residues in foods prepared from the mint
oil will not exceed the Section 408 tolerance, and that the food additive regulations on
the oils can be revoked. These data will be considered confirmatory.
TOLERANCE REASSESSMENT SUMMARY
tCH>EBA«CESU:STEBHJJ«D3ER4a CFR IS
-------
- ,, •- T^Mi&c;^sm(ri»'tMiM4ocfRJ80^
-------
,
Commodity
Vegetables, fruiting
Vegetables, leafy
Vegetables, root
(exc. carrots)
Vegetables, seed and
pod
Wheat, grain
Wheat, straw
' ;;, tousKANCEs iD&fcB- woofo 40 CFR imam ' '
Current Tolerance
(PPm)
**^^—**sSS^SSSS^^SSSSS^S
0.05 (N)
0.05 (N)
0.05 (N)
0.05 (N)
0.05 (N)
0.05 (N)
Tolerance
Reassessment (ppm)
0.05
Revoke
Revoke
Revoke
0.05
0.1
Comment/Correct Commodity Definition
Fruiting vegetables (except cucurbits)
group
The tolerance should be revoked
concomitant with the establishment of: (i)
separate tolerances for celery and endive;
(ii) a tolerance for leaves of root and tuber
vegetables group ; and (iii) a tolerance for
Brassica (cole) leafy vegetables group
The tolerance should be revoked
concomitant with the establishment of: (i)
a tolerance for root and tuber vegetables
(except carrots) group ; and (ii) a tolerance
for bulb vegetables group .
The tolerance should be revoked
concomitant with the establishment of: (i)
a tolerance for legume vegetables (dry or
succulent) group ; and (ii) a separate
tolerance for okra.
TBD - To be determined. Reassessment of tolerance(s) cannot be made at this time because additional data
are required.
TOLERANCES THAT itjEMD TO BB J-KOJPOSfJB UNDER 4(f Ctffc 1JWKW7
Commodity
Alfalfa, forage
Almonds, hulls
Barley, grain
Brassica (cole) leafy
vegetables group
Bulb vegetables
group
Celery
Cotton, gin by-
products
Endive
Foliage of legume
vegetables group
Leaves of root and
tuber vegetables
group
Current Tolerance
(ppm)
None
None
None
None
None
None
None
None
None
None
Tolerance
Reassessment (ppm)
TBD a
0.05
0.05
0.05
0.05
0.05
TBDa
0.05
0.05
0.05
ComixiGfit/Cowect Commodity Definition
69
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TOLERANCE THAT KBBD tO B¥1P3ROI'0SfiJ) fcNDER 4ft €$& 3ti&2d7
Commodity
Legume vegetables
(dry or succulent)
group
Mustard seed
Okra
Peanuts, hay
Rape forage
Root and tuber
vegetables (exc.
carrots)
Sorghum, grain
Wheat, forage
Wheat, hay
Current Tolerance
(ppm)
None
None
None
None
None
None
None
None
None
Tolerance
Reassessment (ppm)
0.05
0.01
0.05
0.05
TBD"
0.05
0.05
0.05
0.1
Comment/Correct Commodity Definition
* TBD = To be determined. Reassessment of tolerance(s) cannot be made at this time because additional data
are required.
Commodity
Peppermint oil
Spearmint oil
TOL&RA
Current Tolerance
(ppm)
2.0
2.0
t^CJS& UN0KR 40 CJP
Tolerance
Reassessment (ppm)
Revoke
Revoke
fc 1*5,5090$ " "'"" ' >.'
Comment/Correct Commodity Definition
60 FR 38781; 7/28/95
60 FR 38781; 7/28/95
MAXIMUM RESIDUE LtMitS TO WE>J&]PO«BI> Vtfom SECTION Tw'CfltfDCW /
Commodity
Peppermint oil
Spearmint oil
Maximum Residue Limit
2.0
2.0
Comment/Correct Commodity
Definition
2.
Codex Harmonization
There are no Codex MRLs established or proposed for residues of trifluralin.
Therefore, there are no questions with respect to compatibility of U.S. tolerances with
Codex MRLs.
3. Restricted Use Classification
Trifluralin is not currently classified for restricted use and the Agency has
determined that trifluralin products should not be classified for restricted use at this
time.
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4. Reference Dose (RfD)
Trifluralin is not an RfD exceeder. The RfD for trifluralin is 0.024 mg/kg/day
as determined from the one-year feeding study in dogs. The NOEL was 2.4
mg/kg/day (MRID 42447001). A safety factor of 100 was applied to account for the
inter-species extrapolation (factor of 10) and intra-species variability (factor of 10).
Using tolerances, the Theoretical Maximum Residue Contribution (TMRC) for
the overall U.S. population from published uses is 0.000724 mg/kg/day (3% of the
RfD). The TMRC for non-nursing infants, the highest exposed subgroup, is 0.002438
mg/kg/day (10% of the RfD).
Using percent of crop treated data the Anticipated Residue Contribution (ARC)
for the overall U.S. population from published uses is 0.000126 mg/kg/day (1% of the
RfD). The ARC for non-nursing infants, the highest exposed subgroup, is 0.000429
mg/kg/day (2% of the RfD).
5.
Cancer Classification
The OPP Carcinogenicity Peer Review Committee evaluated all the available
carcinogenicity data on trifluralin (April 4, 1986), and it concluded that there is limited
evidence of carcinogenicity in male and female rats based upon an increase in
combined malignant and benign urinary bladder tumors in females, renal pelvis
carcinomas in male rats, and thyroid gland follicular cell tumors (adenomas plus
carcinomas combined) in males. Trifluralin has been classified as a Group "C"
possible human carcinogen with a Qt* of 0.0077 (mg/kg/day)"1. The upper bound
dietary cancer risk is is approximately 1.0 x 10"6.
6. Water Resources - Implications for Human Health Risk
a.
Ground Water
No ground water label advisory or management plan for trifluralin is
needed at this time. No ground water monitoring studies are needed.
While some ground water detections of trifluralin have been reported,
these are largely either (1) unconfirmed analytically, (2) from very shallow and
extremely vulnerable ground water where every pesticide used (including
immobile and nonpersistent compounds) is found, or (3) at levels much below
0,1 ppb. Consequently, the ground water detections reported to date do not
provide an adequate basis for recommending regulation of trifluralin because of
ground water contamination concerns. Furthermore, trifluralin, while fairly
71
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persistent under aerobic conditions in soil, degrades relatively rapidly
four weeks) under anaerobic conditions and is very immobile in the vast
majority of agricultural soils. The leaching potential of trifluralin appears to be
very low compared to other pesticides that are common ground water
contaminants.
Relatively few data are available on the environmental fate of trifluralin
degradates. If the Agency determines at some point that any degradation
products are of toxicological concern, then additional data on the ground water
contamination potential of trifluralin degradates may be needed.
b.
Surface Water
Trifluralin is not currently regulated under the Safe Drinking Water Act.
Therefore no maximum contaminant level (MCL) has been established and
water supply systems are not required to sample and analyze for the chemical.
It has a lifetime water health advisory level of 5 |ag/L. The 1 day and the 10
day advisory levels are 80 \ig/L. The limited data available to the Agency on
trifluralin in surface water, as well as presumably conservative computer
estimated EECs (Section C.2) suggests that it is probably unlikely that the
annual average concentrations of trifluralin will exceed the lifetime health
advisory or that peak or short term average concentrations will exceed the 1
day or 10 day health advisory in the actual surface water sources for drinking
water. Furthermore, most drinking water supply systems that use surface water
use primary treatment processes likely to be effective in removing trifluralin,
because of the relatively high soil/water partitioning of the chemical. No
surface water advisory is required.
7. Endangered Species Statement
The Agency has concerns about the exposure of threatened and endangered
plant and animal species to trifluralin as discussed above in the science assessment
chapter. The endangered species LOCs have been slightly exceeded for birds,
mammals, and semi-aquatic and aquatic plants. Although the LOCs have not been
exceeded for endangered freshwater and marine or estuarine fish, these species may be
adversely affected based on laboratory and field studies which revealed vertebral
dysplasia after exposure to very low levels of trifluralin.
Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse impacts
on endangered and threatened species and to implement mitigation measures that will
eliminate the adverse impacts. The program would require use modifications or a
generic product label statement, requiring users to consult county-specific bulletins.
72
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These bulletins would provide information about specific use restrictions to protect
endangered and threatened species in the county. Consultations with the Fish and
Wildlife Service will be necessary to assess risks to newly listed species or from
proposed new uses. '
The Agency plans to publish a description of the Endangered Species Program
in the Federal Register in the near future. 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.
8. Aquatic Impact Labeling
Due to trifluralin's toxicity to fish, aquatic invertebrates and estuarine/marine
organisms, the Agency is requiring aquatic impact labeling on all trifluralin end-use
products. For specific language, refer to Section V. of this document.
9. Occupational/Residential Labeling Rationale/Risk Mitigation
a. Uses Within the Scope of the Worker Protection Standard
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 labels 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 that the plants are (or will
be) grown in.
To the Agency's knowledge, some of the currently registered uses of
trifluralin are within the scope of the Worker Protection Standard for
Agricultural Pesticides (WPS) and some uses are outside the scope of the WPS.
Those that are outside the scope of the WPS include use:
on plants grown for other than commercial or research purposes, which
may include plants in habitations, home fruit and vegetable gardens, and
home greenhouses,
73
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• 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).
b. Compliance with the Worker Protection Standard (WPS)
Any product whose labeling reasonably permits use in the production of
an agricultural plant on any farm, forest, nursery, or greenhouse must comply
with the labeling requirements of PR Notice 93-7, "Labeling Revisions
Required by the Worker Protection Standard (WPS), and PP. Notice 93-11,
"Supplemental Guidance for PR Notice 93-7, which reflect the requirements of
EPA1 s labeling regulations for worker protection statements (40 CFR part 156,
subpart K). These labeling revisions are necessary to implement the Worker
Protection Standard for Agricultural Pesticides (40 CFR part 170) and must be
completed in accordance with, and within the deadlines specified in, PR
Notices 93-7 and 93-11. Unless otherwise specifically directed in this RED, all
statements required by PR Notices 93-7 and 93-11 are to be on the product
label exactly as instructed in those notices.
After April 21, 1994, except as otherwise provided in PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS PR
Notice complying labeling when they are distributed or sold by the primary
registrant or any supplementally registered distributor.
After October 23, 1995, except as otherwise provided in PR Notices
93-7 and 93-11, all products within the scope of those notices must bear WPS
PR Notice complying labeling when they are distributed or sold by any person.
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10 and other
applicable notices.
c. Personal Protective Equipment (PPE) for Handlers (Mixer/Loaders
and Applicators; WPS, Non-WPS, and Homeowners)
For each end-use product, PPE requirements for pesticide handlers will
be set during reregi strati on in one of two ways:
1. If the Agency has no special concerns about the acute or other adverse
effects of an active ingredient, the PPE for pesticide handlers will be
established based on the acute toxicity of the end-use product. For
74
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occupational-use products, PPE will be established using the process
described in PR Notice 93-7 or more recent Agency guidelines.
2. If the Agency has special concerns about an active ingredient due to
very high acute toxicity or to certain other adverse effects, such as
allergic effects, cancer, developmental toxicity, or reproductive effects:
In the RED for that active ingredient, the Agency may establish
minimum or "baseline" handler PPE requirements that pertain to
all or most occupational end-use products containing that active
ingredient.
These minimum PPE requirements must be compared with the
PPE that would be designated on the basis of the acute toxicity
of each end-use product.
• The more stringent choice for each type of PPE (i.e., bodywear,
hand protection, footwear, eyewear, etc.) must be placed on the
label of the end-use product.
Trifluralin risks (cancer) are low enough that the Agency believes that
the establishment of active-ingredient-based handler PPE requirements is not
warranted. The Agency notes that the only data available for assessing
exposure for granular 6 and 8-row-planter equipment were studies in which the
applicator was inside an enclosed cab and wearing coveralls over long-sleeved
shirt and long pants and chemical-resistant gloves. However, since the risk
values are quite low (8.0 X 10"9 for private applicators and 8.0 X 10'8 for
commercial applicators) for this exposure scenario and no other exposure
scenario for trifluralin presents unacceptable risk, the Agency has determined
that no active ingredient based PPE should be required for handlers using
granular-8-row-planter equipment or for any other trifluralin handlers.
d. Post-Application Restrictions
Restricted Entry Interval (RED: Under the Worker Protection Standard
(WPS), interim restricted entry intervals (REI) for all uses within the scope of
the WPS are based on the acute toxicity of the active ingredient. The toxicity
categories of the active ingredient for acute dermal toxicity, eye irritation
potential, and skin irritation potential are used to determine the interim WPS
REI. If one or more of the three acute toxicity effects are in toxicity category I,
the interim WPS REI is established at 48 hours. If none of the acute toxicity
effects are in category I, but one or more of the three is classified as category
II, the interim WPS REI is established at 24 hours. If none of the three acute
75
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toxicity effects are in category I or II, the interim WPS REI is established at 12
hours. A 48-hour REI is increased to 72 hours when an organophosphate
pesticide is applied outdoors in arid areas. In addition, the WPS specifically
retains two types of REI's established by the Agency prior to the promulgation
of the WPS: (1) product-specific REI's established on the basis of adequate
data, and (2) interim REIs that are longer than those that would be established
under the WPS.
For occupational end-use products containing trifluralin as an active
ingredient, the Agency is requiring that the current WPS-established 12-hour
restricted-entry interval (REI) for each use of the product that is within the
scope of the WPS be maintained. The basis for this recommendation is that
trifluralin is categorized as toxicity category HE for acute dermal toxicity,
category III for eye irritation potential, and category IV for dermal irritation.
However, since trifluralin is classified as a category C carcinogen, the Agency
has determined that the minimum acceptable REI is 12 hours.
Early Entry Personal Protective Equipment (PPE); The Agency has
determined that potential for exposure exists for persons entering treated sites
after application is complete, such as re-entering treated turf areas (e.g.,
residential lawns, recreational areas, and sod farms), treated ornamental sites
(especially nursery sites), and treated established food/feed/fiber crop areas
(such as tree fruits/nuts, grapes, and brambles). 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 is a prohibition of routine entry to perform hand labor tasks and the
requirement that personal protective equipment be worn. Personal protective
equipment requirements for persons who must enter areas that remain under a
restricted-entry interval are based on the toxicity concerns about the active
ingredient. The requirements are set in one of two ways.
1. If the Agency has no special concerns about the acute or other adverse
effects of an active ingredient, it establishes the early-entry PPE
requirements based on the acute dermal toxicity, skin irritation potential,
and eye irritation potential of the active ingredient.
2. If the Agency has special concerns about an active ingredient due to
very high acute toxicity or to certain other adverse effects, such as
allergic effects, cancer, developmental toxicity, or reproductive effects,
it may establish early-entry PPE requirements that are more stringent
than would be established otherwise.
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In the RED for that active ingredient, the Agency may establish
minimum or "baseline" handler PPE requirements that pertain to
all or most occupational end-use products containing that active
ingredient.
These minimum PPE requirements must be compared with the
PPE that would be designated on the basis of the acute toxicity
of each end-use product.
• The more stringent choice for each type of PPE (i.e., body wear,
hand protection, footwear, eyewear, etc.) must be placed on the
label of the end-use product.
Since trifluralin is classified as category IV for acute dermal toxicity
and as category III for eye irritation potential and IV for dermal irritation, and
the Agency has no concerns with regard to occupational exposure that warrant
the establishment of active ingredient based PPE, the PPE required for early
entry is the minimum post-application early entry PPE required under the WPS:
coveralls, chemical-resistant gloves, shoes, and socks.
Entry Restrictions for Occupational-Use Products (Non-WPS Uses); The
Agency is establishing entry restrictions for all non-WPS occupational uses of
trifluralin liquid and granular end-use products. These requirements are
specified in Section V.
Entry Restrictions for Home-Use Products; The Agency is requiring that
home-use liquid and granular products carry the label statements specified in
Section V.
Other Labeling Requirements; The Agency is requiring other labeling
requirements pertaining to occupational and residential exposures. These
requirements are specified in Section V.
requiieiiieius pci taming iu uuuupauuiuu i
requirements are specified in Section V.
10. Other Regulatory Restrictions
The Agency is concerned about trifluralin Special Local Needs (SLN)
registrations for the uses of trifluralin on clover and bermudagrass grown for seed
production only. These uses are eligible for reregistration provided that the
registrant/state lead agencies either 1) reach an agreement within 6 months of the date
of receipt of this RED which provides for adequate legal/regulatory mechanisms to
prevent feed uses of the seed crop(s) and forages, hays, straws from the seed crops or
2) provide a formal commitment to generate residue data depicting residues of
77
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trifluralin in/on clover forage and hay and bermudagrass forage and hay. See Section
V.2.d.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration of
both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of trifluralin for the above
eligible uses has been reviewed and determined to be substantially complete.
However, additional confirmatory data are needed to fulfill the requirements listed
below. Some of these requirements were levied in the trifluralin Registration Standard
and in previously issued Data Call-In Notices. Only the data requirements that have
not been previously levied by the Agency will be included in the generic Data Call-In
Notice (DCI) includes as an attachment to this RED document,
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
62-1 Preliminary Analysis for Nitrosamine
123-la Seed Germination/Seedling Emergence
132-la Foliar Residue Dissipation**
133-3 Dermal Exposure Upon Reentry**
231 Dermal Exposure from Mixing/Loading/Applying**
232 Inhalation Exposure from Mixing/Loadmg/Applying**
163-2 Lab Volatility
171-4e Storage Stability (field trial data on (i) barley or wheat forage,
hay and straw; (ii) carrots; and (iii) grapes)
171-4k Corn, Field, Forage, Fodder, and Silage (method validation data)
171-4k Alfalfa, Forage and Hay
171-4k Cotton Gin Byproducts
171-4k Rape Forage (Alternatively, the Agency would translate
sunflower forage data, if available, to rape forage)
171-4k Dill
171-4k Non-Grass Forage/Fodder/Straw/Hay
171-41 Peppermint/Spearmint Processing
** Levied in the March, 1995 turf DCI
78
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2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing-use (MP) product
labeling must be revised to comply with all current Agency 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):
(fill blank only with those uses that are being supported by MP registrant)."
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 complied with
U.S. EPA submission requirements regarding the 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 formulator, user group, or grower has complied
with U.S. EPA submission requirements regarding the 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. The product specific data requirements are listed in Appendix G, the
Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit to
conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for
each product.
79
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2. Labeling Requirements for End-Use Products
a.
Personal Protective Equipment (PPE)/Engineering Control
Requirements for Pesticide Handlers (Mixers/Loaders and
Applicators)
For sole-active-ingredient end-use products that contain trifluralin, the
product labeling must be revised to adopt the handler PPE/engineering control
requirements set forth in this section. Any conflicting PPE requirements on the
current labeling must be removed.
For multiple-active-ingredient end-use products that contain trifluralin,
the handler PPE/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.
(1) Products Intended Primarily for Occupational Use (WPS
and Non-WPS)
Minimum (Baseline) PPE/Engineering Control Requirements: The
Agency is not establishing active-ingredient-based minimum (baseline)
PPE/engineering control requirements for trifluralin end-use products
that are intended primarily for occupational use.
Determining PPE Requirements for End-use Product Labels; Any
necessary PPE for each trifluralin occupational end-use product will be
established on the basis of the end-use product's acute toxicity
category.
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.
(2) Products Intended Primarily for Homeowner Use
Minimum (Baseline) PPE/Engineering Control Requirements; EPA
is not establishing active-ingredient-based minimum (baseline) handler
PPE for trifluralin end-use products that are intended primarily for
homeowner use.
80
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Determining PPE Requirements for End-Use Product Labels; Any
• necessary PPE for each trifluralin 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 must be placed on the end-use product labeling
immediately following the precautionary statements in the labeling
section "Hazards to Humans (and domestic animals)."
b. Entry Restrictions
For sole-active-ingredient end-use products that contain trifluralin 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-ingredient end-use products that contain trifluralin
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."
(1) Products Intended Primarily for Occupational Use (WPS
Uses)
Restricted-entry interval; A 12-hour restricted-entry interval (REI)
is required for uses within the scope of the WPS on all trifluralin end-
use products.
(Registrant place the following statement on the labeling, if some WPS
uses may be soil-incorporated:')
"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."
Earlv-Entrv Personal Protective Equipment (PPE); The PPE
required for early entry is:
* Coveralls
* Chemical-resistant gloves
* Socks plus shoes
81
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Placement in Labeling; The REI must be inserted into the
standardized REI statement required by Supplement Three of PR Notice
93-7.
The PPE required for early entry must be inserted into the
standardized early-entry PPE statement required by Supplement Three
of PR Notice 93-7.
(2) Products Intended Primarily for Occupational Use (Non-
WPS Uses)
Entry Restrictions; The Agency is establishing the following entry
restrictions for non-WPS occupational uses of trifluralin end-use
products:
For liquid applications:
"Do not enter or allow others to enter the treated area until sprays
have dried."
For granular applications:
"Do not enter or allow others to enter the treated area until dusts
have settled. If soil incorporation is required after the
application, do not enter or allow others to enter the treated area
(except those persons involved in the incorporation) until the
incorporation is complete. If the incorporation is accomplished
by watering-in, do not enter or allow others to enter the treated
area until the surface is dry after the watering-in."
Placement in Labeling; If WPS uses are also on the 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 non-
WPS entry restrictions in the Directions for Use, under the heading
"Entry Restrictions."
(3) Products Intended Primarily for Homeowner Use
Entry Restrictions; The Agency is establishing the following entry
restrictions for all homeowner uses of trifluralin end-use products:
82
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For liquid applications:
"Do not allow people or pets to enter the treated area until sprays
have dried."
For dry applications:
"Do not allow people or pets to enter the treated area until dusts
have settled. If watering-in is required after the application, do
not enter or allow others to enter the treated areas (except those
involved in the watering) until the watering-in is complete and
the surface is dry."
Placement in Labeling; Place the appropriate entry restrictions in the
Directions for Use, under the heading "Entry Restrictions."
c. Other Labeling Requirements
(1) Products Intended Primarily for Occupational Use
The Agency is requiring the following labeling statements to be
located on all end-use products containing trifluralin 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: ^Registrant, place the following statements
on the labeling ONLY if coveralls are required for pesticide handlers:)
83
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"Discard clothing or other absorbent materials that have been
drenched or heavily contaminated with this product's
concentrate. Do not reuse them."
(Registrant place the following statements on all labeling of
end-use products intended primarily for occupational use:)
"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."
User Safety Recommendations:
"Users should wash hands before eating, drinking, chewing gum,
using tobacco, or using the toilet."
"Users should remove clothing immediately if pesticide gets
inside. Then wash thoroughly and put on clean clothing."
"Users should remove PPE immediately after handling this
product. Wash the outside of gloves before removing. As soon as
possible, wash thoroughly and change into clean clothing."
Skin Sensitizer Statement:
"This product may cause skin sensitization reactions in some
people."
(2) 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."
84
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d. Aquatic Impact Labeling
The following label statement is required on all end-use products:
"This pesticide is extremely toxic to freshwater marine, and estuarine
fish and aquatic invertebrates including shrimp and oyster. Do not
apply in a manner which will directly expose canals, lakes, streams,
ponds, marshes or estuaries to aerial drift. Do not contaminate water
when disposing of equipment washwaters."
For non-homeowner products: "Do not apply directly to water, or to
areas where surface water is present or to intertidal areas below the
mean high water mark."
For homeowner products: "Do not apply directly to water."
e. 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.
85
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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.
• 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.
86
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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
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 altitude 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
87
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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).
3. Other Regulatory Requirements
In order for the Agency to consider trifluralin Special Local Needs registrations
uses on clover an'd bermudagrass grown for seed production only eligible for
reregistration, the registrant/state lead agencies must either 1) reach an agreement
within 6 months of the date of receipt of this RED which provides for adequate
legal/regulatory mechanisms to prevent feed uses of the seed crop(s) and forages,
hays, straws from the seed crop(s) or 2) provide a formal commitment to generate data
to support these uses.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for
26 months from the date of the issuance of this Reregistration Eligibility Decision (RED).
Persons other than the registrant may generally distribute or sell such products for 50
months from the date of the issuance of this RED. However, existing stocks time frames
will be established case-by-case, depending on the number of products involved, the
number of label changes, and other factors. Refer to "Existing Stocks of Pesticide Products;
Statement of Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell trifluralin products
bearing old labels/labeling for 26 months from the date of issuance of this RED. Persons
other than the registrant may distribute or sell such products for 50 months from the date of
the issuance of this RED. Registrants and persons other than registrants remain obligated to
meet pre-existing Agency imposed label changes and existing stocks requirements
applicable to products they sell or distribute.
88
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VI. APPENDICES
89
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APPENDIX A.Table for Use Patterns Subject to Reregistration
Appendix A is approximately 600 pages long and is not being included. Copies of Appendix A are available upon request per the instructions in Appendix D.
-------
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active ingredients within
ic case trifluralin covered by this Reregistration Eligibility Decision Document. It contains generic data
:quirements that apply to trifluralin in all products, including data requirements for which a "typical formulation"
s 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
art 158. the reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment
uidelines, which are available from the National Technical Information Service, 5285 Port Royal Road,
pringfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data requirements apply. The
ollowing 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 Forestiy
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
dentifying number of each study. This normally is the Master Record Identification (MRDD) number, but may be a
GS" number if no MRCD number has been assigned. Refer to the Bibliography appendix for a complete citation of
study.
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes
of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen
to show a personal author. When no individual was identified, the Agency has shown
an identifiable laboratory or testing facility as the author. When no author or
laboratory could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the
date is followed by a question mark, the bibliographer has deduced the date from the
129
-------
evidence contained in the document. When the date appears as (19??), the Agency
was unable to determine or estimate the date of the document.
Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
number, or other administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to
the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the
original submission of the study appears. The six-digit accession number
follows the symbol "CDL," which stands for "Company Data Library." This
accession number is in turn followed by an alphabetic suffix which shows the
relative position of the study within the volume.
130
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BIBLIOGRAPHY
MRID
CITATION
00022257
00022376
00022793
00023105
00024731
00026049
00026054
Eli Lilly and Company (1967) Supplemental Residue Data: Trifluralin-Irish
Potatoes. (Unpublished study received Mar 12, 1968 under 1471-35; submitted
by Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis Ind.;
CDL:006227-B)
Shaw, A.; Thaemert, E.; Binning, L.K.; et al. (1975) Eptam 7-E + Treflan 4-E
Tank Mix on Beans. (Unpublished study received Jul 20, 1976 under
476-2154; prepared in cooperation with Morse Laboratories, Inc. and Univ. of
Wisconsin, submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:224906-A)
Sckerl, M. (1978) Residue Data Treflan and Planavin Herbicides in Soybeans:
TIR-24-305-76-C. (Unpublished study including TIR24-143-72-B, received
Jul 18 1979 under 201-279; prepared in cooperation with Agri-Research,
submitted by Shell Chemical Co., Washington, D.C.; CDL:098395-O)
Fisher, D.E.; St. John, L.E., Jr.; Guntenman, W.E.; et al. (1965) Fate of Banvel
T, loxynil, Tordon and Trifluorilin in the dairy cow. Journal of Dairy Science
48(12):1711-1715. (Also in unpublished submission received Apr 8, 1976
under 876-203; submitted by Velsicol Chemical Corp., Chicago, 111.;
CDL:235226-Y)
Penner, D. (1971) Effect of temperature on phytotoxicity and root uptake of
several herbicides. Weed Science 19(5):571-575. (Also in unpublished
submission received Jul 19, 1978 under 201403; submitted by Shell Chemical
Co., Washington, D.C.; CDL: 234470-AI)
Merkle, M.G.; Spears, B.R. (1969) Crop Residue Report: Vernam 6E Treflan
4E: FSDS No. B-0458. (Unpublished study including FSDS nos. B-0457,
B-0456, B-0455..., received Dec 8, 1969 under 476-1807; prepared in
• cooperation with Texas A & M Univ., submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:003788-B)
Golab, T.; Herberg, R.J.; Parka, S.J.; et al. (1967) Metabolism of Carbon-14
Trifluralin in carrots. Journal of Agricultural and Food Chemistry
15(4):63 8-641. (Also in unpublished submission received Jan 3, 1971 under
OF0981; submitted by Shell Chemical Co., Washington, D.C.; CDL:091687-C)
131
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MRID
BIBLIOGRAPHY
CITATION
00030932 Baychem Corporation (1973) Treflan plus Sencor-Soybeans. (Unpublished
study received Feb 15, 1973 under 1471-EX-40; submitted by Blanco Products
Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:210010-B)
00032811 Blanco Products Company (1978) Trifluralm«Corn. (Unpublished study
received Jun 23, 1980 under CO 80/9; CDL:242716-B)
00033086 Manning, P.B.; Kerr, T.W.; Olney, C.E.; et al. (1964) Residue Study.
(Unpublished study including published data, received Jan 14, 1965 under
•100-471; prepared by Univ. of Rhode Island, Agricultural Experiment Station
and others, submitted by CibaGeigy Corp., Greensboro, N.C.; CDL:000459-E)
00033087 Manning, P.B.; Kerr, T.W.; Olney, C.E.; et al. (1964) Residue Study.
(Unpublished study including published data, received Jan 14, 1965 under
100-471; prepared in cooperation with Univ. of Rhode Island, Agricultural
Experiment Station and Gaspro, Ltd., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL: 000459-F)
00044337 Emmerson, J.L.; Pierce, B.C.; McGrath, J.P.; et al. (1980) The Chronic Toxicity
of Compound 36352 (Trifluralin) Given as a Component of the Diet to Fischer
344 Rats for Two Years: Studies R-87 and R-97. (Unpublished study received
Sep 18, 1980 under 1471-35; submitted by Blanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, Ind.; CDL:243289-A, 243290)
00044338 Emmerson, J.L.; Owen, N.V.; McGrath, J.D.; et al. (1980) The Chronic
Toxicity of Compound 36352 (Trifluralin) Given as a Component of the Diet to
the B6C3F1 Mouse for 24 Months: Studies M9067 and M-9077. (Unpublished
study received Sep 18, 1980 under 1471-35; submitted by Blanco Products Co.,
Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:243291-A; 243292; 243293)
00047591 Blanco Products Company (1967?) Determination of Trifluralin, Diphenamid
and N-Methyl-2,2-diphenylacetamide in Tomatoes. Undated method no.
5800600. (Unpublished study received Aug 22, 1968 under 8F0717;
CDL:093027-B)
00047639 Armock, I.; Knight, C.W.; Leavitt, R.A.; et al. (1979) Summary: Efficacy of
Trifluralin for Weed Control in Rape. (Unpublished study including PR no.
1124, received Jul 29, 1980 under OE2394; prepared in cooperation with
132
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BIBLIOGRAPHY
MRID
CITATION
00057545
00057546
00057547
00059531
00059532
00067222
00067371
Michigan State Univ., Pesticide Research Center and others, submitted by ,
Interregional Research Project No. 4, New Brunswick, N.J.; CDL: 099525-A)
Stauffer Chemical Company (1981) Eptam 7-E + Treflan 4-EC Tank Mix
Applied Preplant Incorporated to Sunflowers. (Compilation; unpublished study
received Feb 13, 1981 under 476-2154; CDL: 244420-A)
Stauffer Chemical Company (1981) Eptam 7-E + Treflan 4-EC Tank Mix
Applied Postemergence Incorporated in Sugarbeets. (Compilation;
unpublished study received Feb 13, 1981 under 476-2154; CDL: 244420-B)
Stauffer Chemical Company (1979) Eptam 7-E + Treflan 4-EC Tank Mix
Applied Preplant Incorporated to Snap Beans. (Compilation; unpublished
study received Feb 13, 1981 under 476-2154; CDL: 244420-C)
Eli Lilly and Company (1975) Peanuts-Treflan plus Vernolate. (Compilation;
unpublished study received Mar 13, 1975 under 1471-EX-47; CDL:224660-B)
Johnson, W.S. (1972) Determination of Trifiuralin in Agricultural Crops and
Soil. Method No. 5801616 dated Jul 20, 1972. (Unpublished study received
Mar 13, 1975 under 1471-EX-47; submitted by Blanco Products Co., Div. of
Eli Lilly & Co., Indianapolis, Ind.; CDL:224660-C)
Frank, R.; Johnson, W.S.; Sieck, R.F.; et al. (1978) Residue Data on Trifiuralin
and Vernolate in Peanuts When Preplant Incorporated as an EC Formulation.
Includes procedure no. 5801616 dated May 24, 1977 and undated procedure
no. 5801690. (Unpublished study received Jul 25, 1980 under 1471-35;
submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind •
CDL:243059-A)
Danhaus, R.G.; Mestdagh, P.; Schreurs, R.; et al. (1980) Residues of Triallate,
Trifiuralin and EPTC in Oilseeds following Preemergent Applications of Fargo,
Fargo + Treflan, and Fargo + Eptam Tank Mixes: Report No. MSL-1323. Final
rept. Includes undated methods entitled: Analytical residue method for triallate
and trifluralin in oilseed crops and Analytical residue method for EPTC in flax
seed. (Unpublished study, including published data, received Dec 23, 1980
under 524-145; submitted by Monsanto Co., Washington, D.C.; CDL-
099852-A)
133
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MRID
BIBLIOGRAPHY
CITATION
00067430 Harrison, S.L.; Nygren, R.E.; Boros, E.J.; et al. (1980) Chloramben and
Trifluralin Analyses of Sunflowers Treated with Amiben + Treflan Tank Mix
PPI: Project No. 10123/279D. (Unpublished study received Dec 19, 1980
under 264-138; prepared in cooperation with Biospherics, Inc. and Allied
Chemical Services, Ltd., Canada, submitted by Union Carbide Agricultural
Products Co., Inc., Ambler, Pa.; CDL:243984-B)
00067433 Harrison, S.L.; Boros, E.J. (1980) Chloramben, Trifluralin & Metribuzin (+
DADK) Analyses of Soybeans Treated with Amiben + Treflan + Sencor or
Lexone Tank Mix PPI: Project Report 10123/1280A. (Unpublished study
received Dec 19, 1980 under 264-138; prepared in cooperation with Southern
Illinois Univ., Plant & Soil Science Dept. and others, submitted by Union
Carbide Agricultural Products Co., Inc., Ambler, Pa.; CDL:243984-F)
00067435 Decker, O.D.; Griggs, R.D. (1980) Determination of Trifluralin in Agricultural
Crops and Soil. Undated method AM-AA-CA-R023-AA755. (Unpublished
study received Dec 19, 1980 under 264-138; prepared by Eli Lilly and Co.,
submitted by Union Carbide Agricultural Products Co., Inc., Ambler, Pa.;
CDL:243984-I)
00070736 Frank, R.; Sieck, R.F.; Shuey, E.W. (1978) Trifluralin and Triallate on Barley
and Wheat: Residue Data. (Unpublished study received Feb 20, 1981 under
1471-35; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, Ind.; CDL: 244413-A)
00080320 Fisher, D.E.; St. John, L.E., Jr.; Gutenmann, W.H.; et al. (1965?) Fate of
Banvel T, loxynil, Tordon, and Trifluralin in the Dairy Cow. (Unpublished
study received Feb 7, 1967 under unknown admin, no.; prepared by Cornell
Univ., Depts. of Engineering Physics, Entomology and Animal Husbandry,
submitted by Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:105544-D)
00080322 Nellor, J.E. (19??) Influence of Orally Administered Trifluralin on the
Performance and Well Being of Lactating Goats. (Unpublished study received
Feb 7, 1967 under unknown admin, no.; prepared by Michigan State Univ.,
Dept.'of Animal Husbandry, submitted by Blanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, Ind.; CDL:105544-F)
134
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MRID
BIBLIOGRAPHY
CITATION
00084581 Decker, O.D.; Sieck, R.F.; Shuey, E.W. (1981) Trifluralin in Flaxseed When
Used as Pre-plant Soil Incorporated Application for Weed Control: Residue
Data. (Unpublished study received Sep 24, 1981 under 1471-35; prepared in
cooperation with North Dakota State Univ., submitted by Blanco Products Co.,
Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:070366-A)
00093190 Shell Chemical Company (1974) 1973-Residue Data for Treflan in Cottonseed
from Stoneville, Mississippi: TIR-24-195-73 (Part II). (Unpublished study
received Feb 28, 1975 under 5F1599; CDL:094364-O)
00093549 Manning, P.B.; Kerr, T.W.; Olney, C.E.; et al. (1964) Residue analysis of
various fruits and vegetables treated with DCPA, prometryne and trifluralin for
weed control. Pages 105-108,In Proceedings of the Northeastern Weed
Control Conference: Volume 18; Jan 8,9,10, 1964, New York, N.Y. N.P.
(Also in unpublished submission received Dec 1, 1964 under 7F0559;
submitted by Geigy Chemical Co., Ardsley, N.Y.; CDL:090702-E)
00093553 Blanco Products Company (1966?) Radioactive Metabolic Studies.
(Unpublished study received Jan 4, 1967 under 7F0555; CDL: 090690-B)
00093554 Elanco Products Company (1966) Summary of Residue Data. (Compilation;
unpublished study received Jan 4, 1967 under 7F0555; CDL:090690-C;
090689)
00093555 Elanco Products Company (1966) Trifluralin—Cantaloupe and Cucumber.
Includes procedure no. 5801000 dated Jul 1, 1964; procedure no. 5801110
dated Oct 15, 1964; procedure 5801210 dated Jan 1966. (Compilation;
unpublished study received Jan 4, 1967 under 7F0555; CDL:090689-A)
00093574 Elanco Products Company (1966) Residue of Trifluralin-Irish Potatoes.
(Compilation; unpublished study received Jan 24, 1967 under 7F0586;
CDL:090752-A)
00093634 Van Duyn, R.L.; Berkman, R.N. (1965) Trifluralin Residues from a Dairy Cow:
VPR-235-418. (Unpublished study received Jan 25, 1967 under 7F0565;
submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:090711-B)
135
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00093636 Raun, A.P.; Herberg, RJ. (1966) Study of C14-Treflan Excretion in the
Lactating Goat. (Unpublished study received Jan 25, 1967 under 7F0565;
submitted by Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:090711-E)
00093637 Blanco Products Company (1966) Trifluralin-Alfalfa: Summary. (Compilation;
unpublished study, including experiment nos. AAD-1309, AAD-1664,
AAD-1664A..., received Jan 25, 1967 under 7F0565; CDL:090711-I)
00094410 Union Carbide Agricultural Products Company, Incorporated (1975) Residue
Studies on Chloramben, Trifluralin andLinuron in Soybeans. (Compilation;
unpublished study received May 23, 1975 under 264-266; CDL:195120-A)
00096361 Decker, O.D.; Sieck, R.F.; Shuey, E.W. (1981) Residue Data on Trifluralin and
Oryzalin When EL-5219 is Used for Preemergence Weed Control in Soybeans.
(Unpublished study received Feb 10, 1981 under 1471-118; submitted by
Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:244283-A)
00104423 Frank, R.; Amundson, M.; Deal, P.; et al. (1978) Trifluralin and Chloramben on
Soybeans: Residue Data. (Unpublished study received Feb 9, 1978 under
1471-35; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, IN; CDL:232828-A)
00105646 Blanco Products Co. (1965) Trifluralin Residue Data-Peanuts. (Compilation;
unpublished study received Mar 23, 1965 under 1471-35; CDL:005968-B)
00105648 Blanco Products Co. (1966) Trifluralin-Sugar Beets. (Unpublished study
received Mar 31, 1967 under 1471-35; CDL:006208-B)
00105650 Little, C.; Hunt, H. (1968) Supplemental Trifluralin Residue Data on Cole
Crops Harvested in 1967 and 1968. (Unpublished study received Feb 10, 1969
under 1471-35; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, IN; CDL: 006241-B)
00105655 Mobay Chemical Corp. (1973) Residue Data on Treflan: Preplant Soil
Incorporated Followed by Sencor Surface Applied for Preemergence Weed
Control in Soybeans. (Compilation; unpublished study received Mar 1, 1973
under 3125-277; CDL:007214-B)
136
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BIBLIOGRAPHY
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00105666 Blanco Products Co. (1966) The Results of Tests on the Amount of Residue
Remaining, Including a Description of the Analytical Method Used: Trifluralin.
(Compilation; unpublished study received on unknown date under 6F0493;
CDL:090567-A)
00105667 Blanco Products Co. (1966) Residue Data on Trifluralin in Citrus, Stone Fruit,
Nuts, Vine Crops, and Pome Fruit. (Compilation; unpublished study received
on unknown date under 7G0533; CDL: 090649-A)
00105668 Eli Lilly and Co. (1967) Residue Data on Trifluralin in Sugarcane.
(Unpublished study received on unknown date under 7G0595; CDL:
090765-A)
00105669 Blanco Products Co. (1967) The Results of Tests on the Amount of Residue
Remaining, Including a Description of the Analytical Method Used: Trifluralin.
(Compilation; unpublished study received Nov 28, 1967 under 8F0664;
CDL:091163-A)
00105670 Eli Lilly and Co. (1967) Residue Data on Trifluralin in Watermelon, Celery,
Mungbeans, and Guar Beans. (Unpublished study received Feb 14, 1968 under
8F0664; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, IN; CDL:091164-A)
00105673 Eli Lilly and Co. (1967) Residue Data on Trifluralin in Sunflower Seed.
(Compilation; unpublished study received Apr 5, 1968 under 8F0679;
CDL:091186-A)
00105674 Eli Lilly'and Co. (1968) Supplemental Residue Data on Trifluralin in
Sugarcane. (Compilation; unpublished study received Apr 6, 1968 under
8F0715; CDL:091238-A)
00105675 Blanco Products Co. (1968) Trifluralin: Residues in Almonds and Other Nuts.
(Compilation; unpublished study received Dec 1, 1968 under 8F0721;
CDL:091243-A)
00105677 Blanco Products Co. (1968) Trifluralin: Residues in Apricots and Other Crops.
(Compilation; unpublished study received May 6, 1968 under 8F0731;
CDL:091260-A; 091261)
137
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BIBLIOGRAPHY
CITATION
00105678 Blanco Products Co. (1968) Trifluralin: Residues on Grapes and Other Crops.
(Compilation; unpublished study received Apr 8, 1969 under 9F0787;
CDL:091358-A)
00105681 Little, C.; Bundy, D.; Hunt, H.; et al. (1969) Residue Data on Trifluralin in
Wheat. (Unpublished study received Jun 23, 1969 under 9F0851; submitted by
Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:091473-B)
00105683 Bundy, D.; Macy, T.; Hunt, H.; et al. (1969) Trifluralin: Peppermint and
Spearmint. (Unpublished study received Aug 4, 1969 under OF0862; submitted
by Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:091490-B)
00105689 Blanco Products Co. (1965) Trifluralin Residues in Agronomic Crops.
(Compilation; unpublished study received May 24, 1966 under 6F0493;
CDL:092781-D)
00105690 Blanco Products Co. (1966) Carbon-14 Trifluralin Goat Feeding Experiment.
(Unpublished study received Jul 29, 1968 under 7F0565; CDL:092853-A)
00105691 Blanco Products Co. (1967) Residue Data for Trifluralin in Alfalfa.
(Compilation; unpublished study received Feb 6, 1967 under 7F0565;
CDL:092853-B)
00105695 Holzer, F. (1969) Determination of Trifluralin Residues in Mint Oil: Procedure
5801577. (Unpublished study received Aug 4, 1969 under OF0862; submitted
by Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:093159-A)
00105696 Eli Lilly and Co. (1974) Residue Data on Treflan 4 EC When Used for Weed
Control in Established Asparagus. (Unpublished study received on unknown
date under 4G1501; submitted by Blanco Products Co., Div. of Eli Lilly and
Co., Indianapolis, IN; CDL:093981-A)
00105697 U.S. Dept. of Agriculture (1973) Treflan Residues in Corn and Soil.
(Compilation; unpublished study received May 23, 1974 under 4E1509;
CDL:094632-A)
138
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MRID
BIBLIOGRAPHY
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00105702 Frank, R.; Johnson, W. (1976) Residue Data on Trifluralin in Asparagus When
Incorporated into the Soil as a 4EC Formulation. (Unpublished study received
Dec 14, 1978 under 1471-35; submitted by Blanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, IN; CDL:097696-B)
00105704 Frank, R.; Sieck, R.; Shuey, E. (1979) Trifluralin in Barley and Grain Sorghum
When Postplant Soil Incorporated: Residue Data. (Unpublished study received
Feb 7, 1979 under 1471-35; submitted by Blanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, IN; CDL:097790-A)
00105710 Johnson, W.; Griggs; Turner (1975) Residue Data on Trifluralin and
Diphenarnid When Trefmid Plus Dymid Is Preplant Soil Incorporated for Weed
Control in Direct-seeded Tomatoes. (Unpublished study received Apr 28, 1975
under 1471-68; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, IN; CDL: 101101-A)
00105713 Blanco Products Co. (1963) Residues of Trifluralin in Cottonseed.
(Compilation; unpublished study received May 13, 1963 under 1471-35;
CDL:101591-A)
00105716 Scroggs, R. (19??) Undated letter sent to R. Hill: Stability of trifluralin in
cottonseed (raw agricultural commodity). (Unpublished study received May 21,
1964 under 1471-35; submitted by Blanco Products Co., Div. of Eli Lilly and
Co., Indianapolis, IN; CDL:101598-A)
00105717 Johnson, W.; Thornton, J.; Schumann, S.; et al. (1973) Residue Data on Trefian
B.C. and Sencor 50W When Tank-mixed for Weed Control in Soybeans.
(Unpublished study received Nov 28, 1973 under 1471-35; submitted by
Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:101604-A)
00105720 Blanco Products Co. (1964) General Summary: Trefian B.C.. (Compilation;
unpublished study received May 7, 1964 under 1471-35; CDL:101595-A)
00105724 Bundy, D.; Griggs, D.; Little, C.; et al. (1968) Residue Data on Trifluralin in
Collard, Kale, Mustard, and Turnip Greens. (Unpublished study received Aug
26, 1968 under 1471-35; submitted by Blanco Products Co., Div. of Eli Lilly
and Co., Indianapolis, IN; CDL:101679-A)
139
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CITATION
00105725 Hunt, H. (1970) Residue Data on Trifluralin as a Preplant Application for
Control of Rhizome Johnsongrass in Soybeans. (Unpublished study received
Feb 3, 1971 under 1471-35; submitted by Blanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, IN; CDL:101680-A)
00105726 Johnson, W.; Oliva, M.; Macy, T.; et al. (1973) Residue Data on Treflan
Applied by Subsurface Injection for Bindweed Control. (Unpublished study
received Jul 26, 1974 under 1471-35; submitted by Blanco Products Co., Div.
of Eli Lilly and Co., Indianapolis, IN; CDL: 101681-A)
00105727 Hunt, H. (1970) Trifluralin for Pre-emergence Weed Control in Sugarcane
When Surface Applied in Hawaii (Experimental Permit). (Unpublished study
received May 11, 1971 under 1471-35; submitted by Blanco Products Co., Div.
of Eli Lilly and Co., Indianapolis, IN; CDL:101682-A)
00105729 Johnson, W.; Turner, L.; Macy, T.; et al. (1973) Residue Data on Treflan as a
Preplant Application for Rhizome Johnsongrass Control in Cotton.
(Unpublished study received Sep 26, 1973 under 1471-35; submitted by Blanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL: 101683-A)
00105730 Johnson, W.; Oliva, M.; Bewley, G.; et al. (1974) Residue Data on Treflan 4EC
for Preemergence Control of Weeds in Stubble (Ratoon) Sugarcane, as a Layby
Application for Plant Sugarcane, and for the Control of Raoulgrass (Itchgrass)
in Sugarcane (Louisiana and Texas). (Unpublished study received Aug 28,
1974 under 1471-35; submitted by Blanco Products Co., Div. of Eli Lilly and
Co., Indianapolis, IN; CDL:101684-A)
00105731 Blanco Products Co. (1965) Treflan for Pre-emergence Weed Control in
Cotton: Research Data. (Compilation; unpublished study received May 27,
1965 under 1471-35; CDL:101685-A)
00105733 Johnson, W.; Oliva, M. (1973) Residue Data on Treflan as a Postemergence
Treatment for Weed Control in Potatoes. (Unpublished study received Aug 31,
1973 under 1471-35; submitted by Blanco Products Co., Div. of Eli Lily and
Co., Indianapolis, IN; CDL:101688-A)
00105734 Johnson, W.; Oliva, M. (1973) Residue Data on Treflan Preplant and Postplant
Application for Weed Control in Potatoes. (Unpublished study received Aug
140
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BIBLIOGRAPHY
CITATION
31, 1973 under 1471-35; submitted by Blanco Products Co., Div. ,of Eli Lilly
and Co., Indianapolis, IN; CDL:101689-A)
00105735 Johnson, W.; Oliva, M.; Macy, T; et al. (1973) Residue Data on Treflan EC for
Weed Control in Gearing Plum and Prune Trees. (Unpublished study received
Mar 6, 1974 under 1471-35; submitted by Blanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, IN; CDL:101690-A)
00105746 Cole, P.; Miller, D.; Purvis, A.; et al. (1975) Residue Data on Trifluralin EC
Applied at Increased Rates as a Tank-mix with Metribuzin WP for Weed
Control in Soybeans. (Unpublished study received Jun 11, 1975 under
1471-35; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, IN; CDL: 115267-A)
00105749 Scholz, N. (1964) Residue Data on Trifluralin in Green Beans, Lima Beans,
Dry Beans, Southern Peas, Broccoli, Brussels Sprouts, Cabbage, and
Cauliflower. (Unpublished study received Jan 4, 1965 under 1471-35;
submitted, by Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:119193-A) ' .
00105750 Eli Lilly and Co. (1964) Residue Data on Trifluralin in Safflower, Okra, and
Transplant Tomatoes and Peppers. (Unpublished study received Jan 4, 1965
under 1471-35; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Ijidianapolis, IN; CDL:119195-A)
00105751 Blanco Products Co. (1964) Summary: Trifluralin. (Compilation; unpublished
study received May 21, 1964 under 1471-35; CDL: 119196-A)
00105755 Johnson, W. (1975) Residue Data on Trifluralin Plus Triallate When
Tank-mixed and Preplant Soil Incorporated for Weed Control in Peas.
(Unpublished study received Jul 16, 1975 under 147135; submitted by Blanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:123535-A)
00105757 Blanco Products Co. (1965) Treflan for Weed Control in Sugar Beets.
(Compilation; unpublished study received Mar 10, 1965 under unknown
admin, no.; CDL:126630-A)
141
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MRID
BIBLIOGRAPHY
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00105759 Blanco Products Co. (1963) General Summary: Trifluralin Studies.
(Compilation; unpublished study received Oct 10, 1963 under 1471-35;
CDL:119190-A; 120368; 119194)
00105772 Blanco Products Co. (1975) Trifluralin ...: PRNotice 70-15 Data. (Compilation;
unpublished study received Jul 16, 1975 under 1471-35; CDL:222334-A)
00105776 Consultox Laboratories Ltd. (1974) Trifluralin Acute Oral and Dermal Toxicity
Evaluation: CL74: 101: 1051A. (Unpublished study received Jul 23, 1975
under 33660-3; submitted by Industria Prodotti Chimici, S.p.A., Novate
Milanese, Italy; CDL: 224066-B)
00105780 Blanco Product Co. (1977) Treflan EC Plus Caparol SOW Tank-mix Preplant
Soil Incorporated on Cotton in California, Arizona, New Mexico and Texas.
(Compilation; unpublished study received Aug 2, 1977 under 1471-35;
CDL:230951-A)
00105781 Addison, D.; Grant, D.; Keaton, J.; et al. (1977) Treflan EC Plus Cotoran SOW
Tank-mixed and Preplant Soil Incorporated for Weed Control in Cotton
(Except California and Arizona). (Unpublished study received Aug 2, 1977
under 1471-35; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, IN; CDL:230952-A)
00120263 Decker, O.; Sieck, R.; Shuey, E. (1980) Residues of Trifluralin in Onions
When Used as a Popi Treatment for Weed Control. (Unpublished study
received Dec 9, 1982 under 1471-35; submitted by Blanco Products Co., Div.
of Eli Lilly and Co., Indianapolis, IN; CDL:248981-A)
00124904 West, S.; Day, E.; Amundson, M. (1977) Residues of N-Nitrosodipropylamine
and Trifluralin in Crops from Fields Treated with Treflan: Pre-RPAR Review
Submission #8. (Unpublished study received Dec 21, 1977 under 1471-35;
submitted by Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:233223-C)
00124905 Amundson, M.; Berard, D. (1977) Uptake, Distribution, and Transformation of
N-Nitrosodipropylamine by Soybean Plants: A Summary: Pre-RPAR Review
Submission #8. (Unpublished study received Dec 21, 1977 under 1471-35;
submitted by Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:233223-D)
142
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BIBLIOGRAPHY
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00125299 Berard, D. (1977) Absorption of 14C N-Nitrosodipropylamine by Soybean
Plants from Soil: Submission at EPA/OSPR Meeting. Prelim, rept.
(Unpublished study received Aug 11, 1977 under 1471-35; submitted by
Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:233239-B)
00125303 West, S.; Day, E. (1978) The Determination of Volatile Nitrosamines in Crops
and Soil Treated with Dinitroaniline Herbicides: Pre-RPAR Review
Submission #13. (Presented at the ACS; Mar 17, 1978; unpublished study
received Mar 9, 1978 under 1471-35; submitted by Elanco Products Co., Div.
of Eli Lilly and Co., Indianapolis, IN; CDL:233245-A)
00126660 Probst, G.; Emmerson, J.; Rexroat, M.; et al. (1983) The Effect of Trifluralin
(Compound 36352) on the Induction of Reverse Mutations in Salmonella
typhimurium Using the Ames Test: Study 830221AMS2055. (Unpublished
study received Apr 5, 1983 under 1471-70; submitted by Elanco Products Co.,
Div. of Eli Lilly and Co., Indianapolis, IN; CDL:249846-B)
00126661 Oberly, T.; Emerson, J.; Bewsey, B.; et al. (1983) The Effect of Trifluralin
(Compound 36352) on the Induction of Forward Mutation at the Thymidine
Kinase Locus of L5178Y Mouse Lymphoma Cells: Study 830201MLA2055.
(Unpublished study received Apr 5, 1983 under 1471-70; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:249846-C)
00126662 Neal, S.; Emmerson, J.; Probst, G.; et al. (1983) The Effect of Trifluralin
(Compound 36352) on the in vivo Induction of Sister Chromatid Exchange in
Bone Marrow of Chinese Hamsters: Study 830207SCE2055. (Unpublished
study received Apr 5, 1983 under 1471-70; submitted by Elanco Products Co.,
Div. of Eii Lilly and Co., Indianapolis, IN; CDL:249846-D)
00128308 Decker, O.; Sieck, R.; Shuey, E. (1983) Trifluralin Residue Data in Mature
Soybean Seed When Treflan Is Applied PPI or PPI Plus LBI at Elevated Rates
for Itchgrass Suppression: I-ODD-83-03. (Unpublished study received May 6,
1983 under 1471-35; submitted by Elanco Products Co., Div. of Eli Lilly and
CoJ Indianapolis, IN; CDL:250106-A)
00129059 Hoyt, J.; Markham, J.; Johnson, W.; et al. (1983) A Dominant Lethal Study
with Technical Trifluralin (Compound 36352) in the Wistar Rat: Study
R00283. (Unpublished study received Jun 27, 1983 under 1471-70; submitted
143
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by Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:250598-A)
00131132 Fink, R.; Beavers, J.; Brown, R. (1978) One-generation Reproduction
Study—Mallard Duck: Compound 36352, Trifluralin: Project No. 151-103.
Final Rept. (Unpublished study received Sep 20, 1983 under 1471-70;
prepared by Wildlife International Ltd., submitted by Blanco Products Co., Div.
of Eli Lilly and Co., Indianapolis, IN; CDL:251256-A)
00131134 Fink, R.; Beavers, J.; Brown, R. (1979) One-generation Reproduction
Study-Bobwhite Quail: Compound 36352, Trifluralin: Project No. 151-102.
Final rept. (Unpublished study received Sep 20, 1983 under 1471-70; prepared
by Wildlife International Ltd., submitted by Blanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, IN; CDL:251256-C)
00131135 Mosier, J.; Saunders, D. (1978) A Hydrolysis Study on the Herbicide
Trifluralin. (Unpublished study received Sep 20, 1983 under 1471-70;
submitted by Blanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:251257-A)
00133939 Blanco Products Co. (1975) Residue Data on Trifluralin plus EPTC
Tank-mixed and Preplant Soil Incorporated for Weed Control in Potatoes
Grown in Idaho, Oregon and Washington (Full Registration). (Compilation;
unpublished study received Jul 16, 1975 under 1471-35; CDL:224180-A)
00137573 Cochrane, R.; Hudson, H.; Emmerson, J.; et al. (1983) The Toxicity of
Trifluralin (Compound 36352) to Bobwhite in a Fourteen-day Acute Oral
Study: Study A02383. (Unpublished study received Feb 16, 1984 under
1471-70; submitted by Blanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, IN; CDL:252411-A)
00138857 Kehr, C.; Emmerson, J.; Brannon, D.; et al. (1983) The Toxicity of Trifluralin
(Compound 36352) to Bobwhite in a Five-day Dietary Study: Study 7016-77.
(Unpublished study received Jan 24, 1984 under 1471-70; submitted by Blanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:252283-A)
00138858 Kehr, C.; Emmerson, J.; Brannon, D.; et al. (1983) The Toxicity of Trifluralin
(Compound 36352) to Mallards in a Five-day Dietary Study: Study 7018-77.
144
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(Unpublished study received Jan 24, 1984 under 1471-70; submitted by Blanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:252283-B)
00143667 Decker, O. (1984) Trifluralin Residue Data on Alfalfa following Application of
Treflan for Weed Control: Report No. ODD8412. Unpublished study prepared
by Blanco Product, Div. of Eli Lilly and Co. 61 p.
00151894 Mellano, D. (1982) Study of the Capacity of the Test Article HOE 38474 OH at
208 to Induce "Unscheduled DNA Synthesis" in Cultured Hela Cells: Study
No. M 372. Unpublished study prepared by Istituto Di Ricerche Biomediche
"Antoine Marxer" S.p.A. 19 p.
00151895 Leist; Weigand; Kramer (1981) Testing of Hoe 38474 Active Ingredient for
Mutagenicity in the Micronucleus Test following Oral Administration to NMRI
Mice: (Code: HOE 38474 OH AT 208): Report No. 285/81. Unpublished
report prepared by Hoechst Aktiengesellschaft. 16 p.
00151896 Horstmarm (1984) Dominant-lethal Test for Determination of Mutagenic Effect
in Male NMRI-mice after Oral Adminstration: Trifluralin: Code: Hoe 38474
OHZD99 0002: Report No. 84.0763. Unpublished report prepared by Hoechst
Aktiengesellschaft. 89 p.
00151897 Fumero, S.; Berruto, G. (1982) In vivo Study of Chromosome Aberration in the
Test Article HOE 38474 OH at 208 Administered by Oral Route: Study No. M
373. Unpublished study prepared by Istituto Di Ricerche Biomediche "Antoine
Marxer" S.p.A. 24 p.
00151898 Fumero, S. (1982) Study of the Mutagenic Activity "In Vitro" of the
Compound HOE 38474 OH AT 208 with Schizosaccharomyces Pombe: Study
No. M 374. Unpublished study prepared by Institute Di Ricerche Biomediche
"Antoine Marxer" S.p.A. 16 p.
00151899 Baeder, Weigand, Kramer (1983) Testing for Embryotoxicity in Wister Rats
following Oral Administration: HOE 3 8474 Active Ingredient: Report No.
83.0557: Study No.G2R0383. Unpublished study prepared by Hoechst
Aktiengesellschaft. 51 p.
00151900 Becker, H: (1984) Embryotoxicity Study with Trifluralin Substance Technical
Grade (Code HOE 038474 OH ZD99 0002) in the Rabbit (Oral
145
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Administration): Project No. 032387. Unpublished study prepared by Research
& Consulting Co., AG. 83 p.
00151901 Becker, H. (1984) Multiple Generation Study in the Rat: Trifluralin Substance
Technical Grade (Code : HOE 38474 OH AT210): Project No. 008875.
Unpublished study prepared by Research & Consulting Co., AG. 604 p.
00151902 Ellgehausen, H. (1984) Determination of Trifluralin Substance TechGrade
(Code : HOE 38474 O H AT210) in Rodent Feed: Project No. 008875.
Unpublished study prepared by Research & Consulting Co. 26 p.
00151903 Westen, H. (1984) Multiple Generation Study in Rat: Trifluralin Substance
Technical Grade (Code: HOE 38474 O H AT210): Pathology Report Part II:
Project No. 008875. Unpublished study prepared by Research & Consulting
Co., AG. 704 p.
00151906 Schutz; Weigand; Kramer (1980) Repeated-dose (3 Months) Oral Toxicity
Study of the Active Substance HOE 38474 (Code: HOE 38474 O H AT204)
Administered in the Feed to Rats: Report No. 618/80. Unpublished study
prepared by Hoechst Aktiengesellschaft. 422 p.
00151908 Bathe, R. (1984) 12-Month Oral Toxicity (Feeding) Study in Beagle Dogs:
Trifluralin Substance Technical Grade (Code: HOE 38474 O H AT210):
Project No. 008864: Report Part 1. Unpublished study prepared by Research &
Consulting Co. 43 9 p.
00152419 Byrd, R. (1984) A Teratology Study of Trifluralin (El-152, Compound 36352)
Administered Orally to Charles River CD Rats: Study R08484. Unpublished
study prepared by Lilly Research Labs. 308 p.
00152420 Byrd, R. (1984) A Teratology Study (I) of Trifluralin (El-152, Compound
36352) Administered Orally to Dutch Belted Rabbits: Study B02283.
Unpublished study prepared by Lilly Research Labs. 131 p.
00152421 Byrd, R. (1984) A Teratology Study (II) of Trifluralin (El-152, Compound
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40597801 Carpenter, M.; Fennessey, M. (1988) Determination of the Photolysis Rate of
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40673801 Graper, L.; Rainey, D. (1988) Laboratory Studies of Carbon 14 Trifluralin
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40765601 Young, R. (1988) Mutagenicity Test on Trifluralin Technical Grade: Batch
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41179001 Graper, L.; Rainey, D. (1989) Metabolism of (Carbon 14) Trifluralin in Field
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Adams, E.; Cocke, P. and Gunnoe, M. (1990) The Toxicity of Trifluralin to
Rainbow Trout (Salmo gairdneri) in a 48-Day Early Lifestage Study: Lab
Project Number: FO2489. Unpublished study prepared by Lilly Research
Laboratories. 86 p.
Graper, L. (1990) Addendum to Metabolism of Carbon 14 Trifluralin in Field
Corn (...): Lab Project Number: ABC-0388. Unpublished study prepared by
Lilly Research Laboratories. 17 p.
Berard, D. (1990) Addendum to Characterization and Identification of
Radioactivity in Mustard Plants Grown in Soil Treated with Carbon 14
Trifluralin (. . .): Lab Project Number: ABC-0397. Unpublished compilation
prepared by Lilly Research Laboratories. 49 p.
Decker, O. (1990) Field Dissipation of Trifluralin Following Application of
Treflan to Bare Soil and Seeded with Cotton or Soybeans: Lab Project Number:
AAC8804. Unpublished study prepared by Elanco. 336 p.
Rainey, D. (1990) Confined Rotational Crop Study with Carbon 14 Trifluralin:
Lab Project Number: ABC0411. Unpublished study prepared by DowElanco
86 p.
Decker, O. (1990) Field Dissipation of Trifluralin Following Application of
Treflan to Alfalfa Stubble: Lab Project Number: AAC8805. Unpublished study
prepared by DowElanco. 187 p.
Hudson, J.; Smith, C. (1990) Trifluralin Technical: Storage Stability and
Corrosion Characteristics: Lab Project No: T2E9090008. Unpublished study
prepared by DowElanco. 6 p.
159
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BIBLIOGRAPHY
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41934501 Waldrup, T. (1990) Influence of Trifluralin on the Germination of Seeds of Ten
Plant Species: Lab Project Number: 61990002. Unpublished study prepared by
DowElanco. 13 p.
41934502 Adams, E.; Cocke, P. (1990) Toxicity of Trifluralin to a Freshwater Green Alga
(Selenastrum capriconutum) in a Static Test System: Lab Project Number:
J00989. Unpublished study prepared by Lilly Research Labs. 43 p.
41934503 Waldrup, T. (1990) Influence of Trifluralin Postemergence Spray on the
Vegetative Vigor of Ten Plant Species: Lab Project Number: 61990003.
Unpublished study prepared by DowElanco. 19 p.
42309101 Decker, O. (1992) Trifluralin Dissipation Study: Lab Project Number:
AAC8706. Unpublished study prepared by DowElanco. 347 p.
42325001 Rice, F.; Gresham, M. (1992) Magnitude of the Trifluralin Residues in Grain
Sorghum Processed Commodities: Final Report: Lab Project Number: 38640.
Unpublished study prepared by ABC Labs., Inc., in cooperation with Stewart
Agric. Research Services, Inc. 147 p.
42354501 Rice, F.; Gresham, M. (1992) Magnitude of the Trifluralin Residues in Cotton
Processed Commodities: Final Report: Lab Project Number: 38639: AAC9040.
Unpublished study prepared by ABC Labs, Inc. and South Texas Ag Research.
134 p.
42354502 Rice, F.; Schwab, D.; Gresham, M. (1992) Magnitude of the Trifluralin
Residues in Summer Squash Raw Agricultural Commodities: Final Report: Lab
Project Number: 40032: AAC9015. Unpublished study prepared by ABC Labs,
Inc. 199 p.
42403201 Shackelford, D. (1992) Processing Study with Trifluralin on Corn Grain: Lab
Project Number: AAC9004. Unpublished study prepared by North American
Environmental Chemistry Lab., DowElanco. 131 p.
42430801 Decker, O.; Morgan, R. (1992) Magnitude of Trifluralin Residues in/on
Mustard Seed Following Preplant Treatment of Mustard with Treflan EC
Herbicide: Lab Project Number: AAC9012. Unpublished study prepared by
DowElanco in coop with Stewart Ag. Res. Serv.; ABC Labs, Inc. and Collins
Ag. Conslts. 158 p.
160
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Rutherford, B. (1992) Determination of Trifluralin Residues in Radishes: Lab
Project Number: RES91046/AAC882. Unpublished study prepared by
DowElanco. 46 p.
Decker, O.; Ervick, D. (1992) Residues of Trifluralin in Cherries from Trees
Grown on Orchard Floors Treated with Treflan EC Herbicide: Lab Project
Number: AAC9009. Unpublished study prepared by DowElanco in coop with
Stewart Ag Res. Serv.; ABC Labs, Inc. and others. 218 p.
Decker, O.; Morgan, R. (1992) Magnitude of Trifluralin Residues in Peanuts
and Processing Fractions Derived Therefrom Following Preplant Treatment
with with Treflan EC Herbicide: Lab Project Number: AAC9006. Unpublished
study prepared by DowElanco in coop with Stewart Ag Res. Serv.; ABC Labs,
Inc.; and others. 186 p.
Decker, O.; Morgan, R. (1992) Magnitude of Trifluralin Residues in
Sunflowers and Processing Fractions Derived Therefrom Following Preplant
Treatment with with Treflan EC Herbicide: Lab Project Number: AAC9007.
Unpublished study prepared by DowElanco in coop with Stewart Ag Res.
Serv.; ABC Labs, Inc. and others. 169 p.
Decker, O.; Morgan, R. (1992) Processing Study with Trifluralin on Spring
Wheat: Lab Project Number: AAC9008. Unpublished study prepared by
DowElanco in coop with Stewart Ag Res. Serv.; ABC Labs, Lie.; and others.
158 p.
Meyerhoff, R.; Gunnoe, M. (1992) The Toxicity of Trifluralin to Fathead
Minnow (Pimephales promelas) in a 35-Day Vertebral Lesion Study: Lab
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Trifluralin (Compound 036352) Administered Orally to Beagle Dogs for One
Year (Supp.): Lab Project Number: D07190. Unpublished study prepared by
Lilly Research Labs. 470 p.
Decker, O.; Morgan, R.; Shackleford, D. (1992) Crop Residue Study with
Trifluralin on Field Corn Grain: Lab Project Number: AAC9010. Unpublished
study prepared by DowElanco. 115 p.
161
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42448202 Decker, O.; Ervick, D. (1992) Magnitude of the Residue of Trifluralin in Green
Onion: Lab Project Number: AAC9042. Unpublished study prepared by
DowElanco. 155 p.
42448203 Decker, O.; Morgan, R. (1992) Processing Study with Trifluralin on Soybeans:
Lab Project Number: AAC9005. Unpublished study prepared by DowElanco.
177 p.
42448204 Decker, O.; Ervick, D. (1992) Determination of Trifluralin Residues in Sugar
Beets and Processed Products: Lab Project Number: AAC8817. Unpublished
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42449901 Parrish, P.; Dyer, E.; Enos, J.; et al. (1978) Chronic Toxicity of Chlordane,
Trifluralin, and Pentachlorophenol to Sheepshead Minnows (Cyprinodon
variegatus): Lab Project Number: EPA-600/3-78-010. Unpublished study
prepared by EG&G Bionomics 69 p.
42449902 Liu, D.; Lee, J. (1975) Toxicity of Selected Pesticides to the Bay Mussel
(Mytilus edulis): Lab Project Number: EPA-660/3-75-016. Unpublished study
prepared by Stanford Research Institute. 114 p.
42466001 West, S.; Ervick, D. (1992) 1991 Trifluralin Residue Study on Alfalfa Forage
and Hay Following Applications of Treflan TR-10 (10G) in South Dakota: Lab
Project Number: RES91035. Unpublished study prepared by DowElanco. 25
P-
42466002 West, S.; Ervick, D. (1992) 1991 Trifluralin Residue Study on Alfalfa Forage
and Hay Following Applications of Treflan TR-10 (10G) in New York: Lab
Project Number: AAC9026. Unpublished study prepared by DowElanco. 25
P-
42466003 West, S.; Ervick, D. (1992) 1991 Trifluralin Residue Study on Alfalfa Forage
and Hay Following a Single Application of Treflan EC in South Dakota: Lab
Project Number: RES91034. Unpublished study prepared by DowElanco. 25
P-
42466004 West, S.; Ervick, D. (1992) Trifluralin Residue Study on Alfalfa Forage and
Hay Following Two Applications of Treflan TR-10 (10G) California: Lab
Project Number: AAC9022. Unpublished study prepared by DowElanco. 29 p.
162
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42472302
West, S.; Ervick, D. (1992) Trifluralin Residue Study on Seed and Hay
Produced from Alfalfa Treated with Treflan EC: Lab Project Number:
AAC9029.Z Unpublished study prepared by DowElanco. 32 p.
West, S.; Ervick, D. (1992) Trifluralin Residue Study on Alfalfa Forage and
Hay Following Application of Treflan EC Herbicide to Dormant and New
Growth Alfalfa in New York: Lab Project Number: AAC9027. Unpublished
study prepared by DowElanco. 25 p.
West, S.; Ervick, D. (1992) Trifluralin Residue Study on Alfalfa Forage and
Hay Following a Single Application of Treflan EC in California: Lab Project
Number: AAC9024. Unpublished study prepared by DowElanco. 25 p.
West, S.; Ervick, D. (1992) Trifluralin Residue Study on Alfalfa Hay from
Arizona and California Following Two Applications of Treflan TR-10 Granules
Herbicide: Lab Project Number: AAC9021. Unpublished study prepared by
DowElanco. 38 p.
Fisher, S.; Rutherford, B. (1991) Determination of Trifluralin in Alfalfa: Lab
Project Number: AM-AA-CA-R146-AA-755. Unpublished study prepared by
DowElanco. 14 p.
Day, E. (1992) Summary of Findings from Residue Studies Conducted with
Treflan on Alfalfa: Lab Project Number: ECL92002. Unpublished study
prepared by DowElanco. 15 p.
Decker, O.; Shackelford, D.; Morgan, R. (1992) Magnitude of Triflur alin
Residues in/on Corn Forage Following Post-emergence Treatmnet with Treflan
EC Herbicide: Lab Project Number: AAC9011. Unpublished study prepared by
DowElanco in cooperation with Stewart Ag. Research Services, Inc. and
others. 147 p.
Decker, O.; Morgan, R. (1992) Magnitude of Trifluralin Residues in/ on Peanut
Forage Following Preplant Treatment of Peanut with Treflan EC Herbicide:
Lab Project Number: AAC9013. Unpublished study prepared by DowElanco
in cooperation with Stewart Agricultural Research Services, Inc. and others
190 p.
163
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42514501 Ervick, D.; Shackelford, D. (1992) Determination of Trifluralin Residues in
Potatoes and Processed Products: Lab Project Number: AAC8816.
Unpublished study prepared by DowElanco. 55 p.
42642601 Decker, O.; Shackelford, D.; Ervick, D. (1992) Determination of Residues of
Trifluralin in Oranges and Processed Products Resulting from a Postplant Soil
Application of Treflan 5 Herbicide: Lab Project Number: AAC9014/AAC9030.
Unpublished study prepared by DowElanco in cooperation with
Pan-Agricultrual Labs, Inc., ABC Labs Inc., J. A. Smith Biological Services,
and California State Polytechnic Univ. 367 p.
42695601 Schwab, D. (1993) Evaluating the Effects of Trifluralin on the Germination of
Non-Target Terrestrial Plants: Lab Project Number: 40619. Unpublished study
prepared by ABC Laboratories, Inc. 42 p.
42779001 Decker, O.; Rutherford, B. (1993) Response to the EPA Review of Cropfield
Trial and Process Food Studies for Trifluralin (Supp.): Lab Project Number:
AAC9006.01: AAC9008.01: AAC9005.01. Unpublished study prepared by
DowElanco. 17 p.
42834101 Hughes, J.; Williams, T. (1993) The Toxicity of Trifluralin to Skeletonema
costatum: Lab Project Number: DR-0055-6503: ES-2654: B460-153-3.
Unpublished study prepared by Malcolm Pirnie, Inc. 36 p.
42834102 Hughes, J.; Williams, T. (1993) The Toxicity of Trifluralin to Navicula
pelliculosa: Lab Project Number: B460-153-2: DR-0055-6503: ES-2655.
Unpublished study prepared by Malcolm Pirnie, Inc. 36 p.
42834103 Hughes, J.; Williams, T. (1993) The Toxicity of Trifluralin to Anabaena
flos-aquae: Lab Project Number: B460-153-1: DR-0055-6503: ES-2656.
Unpublished study prepared by Malcolm Pirnie, Inc. 36 p.
42834104 Milazzo, D.; Servinski, M.; Brown, R.; et al. (1993) Trifluralin Technical
Grade 95%: Toxicity to the Aquatic Plant, Duckweed, Lemna gibba L. G-3:
Lab Project Number: DECO-ES-2653. Unpublished study prepared by
Malcolm Pirnie, Inc. 32 p.
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Technical-Validation of Analytical Method for Active Ingredient and
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Number: 93-6407-25. Unpublished study prepared by ARCTECH, Inc. 47 p.
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Project Number: 93-6407-28. Unpublished study prepared by ARTECH Inc
26 p.
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93-6407-26. Unpublished study prepared by ARCTECH, Inc. 29 p.
Rondon, C.; Stashick, J. (1993) Corrosion Characteristics of Triflurex
Technical: Lab Project Number: 93-6407-27. Unpublished study prepared by
ARCTECH, Inc. 34 p.
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Post-Production Discussion: Lab Project Number: 93-DCI. Unpublished study
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Methods to Verify Certified Limits of Six Lots of TRIFLUREX Technical: Lab
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Herbicide (FN-5071): Lab Project Number: GH/C/ 3195. Unpublished study
prepared by Formulation Science and Technology Lab., DowElanco, 62 p.
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Manufacturing Use and End Use Product: Treflan: Lab Project Number:
GH/C/3229. Unpublished study prepared by Formulation Science and
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Ingredients of Trifluralin Technical Grade of Active Ingredient (TGAI): Lab
Project Number: GH-C 3240: FOR93136.01. Unpublished study prepared by
DowElanco. 233 p.
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Ingredients of Treflan 5: Lab Project Number: GH-C 3243. Unpublished study
prepared by DowElanco Formulation Science and Technology Lab. 21 p.
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Chemistry Data: Supplement: Lab Project Number: 976. Unpublished study
prepared by LPi.Ci. Analytical Laboratory. 134 p.
166
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
APR 30 1996
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status Sheet
to submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your product(s)
containing this active ingredient. Within 90 days after you receive this Notice you must
respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 7; or
2. Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3 (for both generic and product specific data), the Requirements Status
and Registrant's Response Form, (see section III-B); or
3. Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with
its requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all
of your products subject to this Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-in Response Forms. Also included is a list of all
registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
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information is authorized under the Paperwork Reduction Act by OMB Approval No.
2070-0107 and 2070-0057 (expiration date 3-31-96).
This Notice is divided into six sections and seven Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I
Section H
Section III
Section IV
Section V
Section VI
Why You are Receiving this Notice
Data Required by this Notice
Compliance with Requirements of this Notice
Consequences of Failure to Comply with this Notice
Registrants' Obligation to Report Possible Unreasonable Adverse
Effects
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
H-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and Registrant's
Response Forms: Attachment 3 (for both generic and product specific data requirements).
Depending on the results of the studies required in this Notice, additional studies/testing may
be required.
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II-B. SCHEDULE FOR.SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
the Requirements Status and Registrant's Response Forms (Attachment 3) within the
timeframes provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have
been established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001
L Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(cX2¥B) NOTICES ISSUED
BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change
the requirements of any previous Data Call-In(s). or any other agreements entered into with
the Agency pertaining to such prior Notice. Registrants must comply with the requirements of
all Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III.
COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to this
Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is
specified in item number 3 on the four Data Call-In forms (Attachments 2 and 3).
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m-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for generic and product specific
data must be submitted to the Agency within 90 days after your receipt of this Notice. Failure
to adequately respond to this Notice within 90 days of your receipt will be a basis for issuing
a Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for
issuance of NOIS due to failure to comply with this Notice are presented in Section IV-A and
IV-B.
in-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 IH-C. A discussion of options relating to requests for data waivers is
contained in Section ni-D.
Two forms apply to generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response. These two forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form.
(contained in Attachments 2 and 3, respectively).
The Data Call-in Response Forms must be submitted as part of every response to this
Notice. The Requirements Status and Registrant's Response Forms also must be submitted if
you do not qualify for a Generic Data Exemption or are not requesting voluntary cancellation
of your 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.
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Voluntary cancellation is item number 5 on both Data Call-In Response Form(s). If you
choose this option, these are the only forms that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
b. Use Deletion -
You may avoid the requirements of this Notice by eliminating the uses of your product to
which the requirements apply. If you wish to amend your registration to delete uses, you must
submit the Requirements Status and Registrant's Response Form (Attachment 3), a completed
application 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 FEFRA, 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.
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To apply for the Generic Data Exemption you must submit a completed Data Call-In
Response Form. Attachment 2 and all supporting documentation. The Generic Data
Exemption is item number 6a on the Data Call-in Response Form. If you claim a generic data
exemption you are not required to complete the Requirements Status and Registrant's
Response Form. Generic Data Exemption cannot be selected as an option for responding to
product specific data requirements.
If you are granted a Generic Data Exemption, you rely on the efforts of other persons to
provide the Agency with the required data. If the registrant(s) who have committed to
generate and submit the required data fail to take appropriate steps to meet requirements or
are no longer in compliance with this Data Call-In Notice, the Agency will consider that both
they and you are not compliance and will normally initiate proceedings to suspend the
registrations of both your and their product(s), unless you commit to submit and do submit the
required data within the specified time. In such cases the Agency generally will not grant a
time extension for submitting the data.
d. Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this Notice.
These options are discussed in Section IE-C.1. of this Notice and comprise options 1 through
6 of item 9 in the instructions for the Requirements Status and Registrant's Response Form
and item 6b on the Data Call-in Response Form. If you choose item 6b (agree to satisfy the
generic data requirements), you must submit the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form as well as any other information/data
pertaining to the option chosen to address the data requirement. Your response must be on
the forms marked "GENERIC" in item number 3.
e. Request for Generic Data Waivers.
Waivers for generic data are discussed in Section III-D.l. of this Notice and are covered by
options 8 and 9 of item 9 in the instructions for the Requirements Status and Registrant's
Response Form. If you choose one of these options, you must submit both forms as well as
any other information/data pertaining to the option chosen to address the data requirement.
2. Product Specific Data Requirements
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this
Notice or (c) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section III-C.2. A discussion of
options relating to requests for data waivers is contained in Section III-D.2.
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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 CalUIn
Response Form must be submitted as part of every response to this Notice. In addition, one
copy of the Requirements Status and Registrant's Response Form also must be submitted for
each product listed on the Data Call-In Response Form unless the voluntary cancellation
option is selected. Please note that the company's authorized representative is required to sign
the first page of the Data Call-In Response Form and Requirements Status and Registrant's
Response Form (if this form is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If you
have 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
produces) containing the active ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit a completed Data Call-In Response Form.
indicating your election of this option. Voluntary cancellation is item number 5 on both the
Generic and Product Specific Data Call-In Response Forms. If you choose this
option, you must complete both Data Call-In response forms. These are the only forms that
you are required to complete.
If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
b. Satisfying the Product Specific Data Requirements of this Notice.
There are various options available to satisfy the product specific data requirements of this
Notice. These options are discussed in Section III-C.2. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the product specific Requirements Status and
Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product specific
data requirements for an MUP or EUP as applicable) on the product specific Data Call-In
Response Form. Note that the options available for addressing product specific data
requirements differ slightly from those options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements. It is important to ensure that you are using the correct
forms and instructions when completing your response to the Reregistration Eligibility
Decision document.
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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.
HI-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1. Generic Data
If you acknowledge on the Generic Data Call-In Response Form that you agree to satisfy
the generic data requirements (i.e. you select item number 6b), then you must select one of the
six options on the Generic Requirements Status and Registrant's Response Form related to
data production for each data requirement. Your option selection should be entered under
item number 9, "Registrant Response." The six options related to data production are the first
six options discussed under item 9 in the instructions for completing the Requirements Status
and Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide you to additional instructions
provided in this Section. The options are:
(1) I will generate and submit data within the specified timeframe (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(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
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the proposed protocol and your reason for wishing to use it. The Agency may choose to reject
a protocol not specified in Section II-C. If the Agency rejects your protocol you will be
notified in writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from the date you are
required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost share or agreeing to share in the cost of
developing that study. This 90-day progress report must include the date the study was or
will be initiated and, for studies to be started within 12 months of commitment, the name and
address of the laboratory(ies) or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year, interim
reports must be submitted at 12 month intervals from the date you are required to commit to
generate or otherwise address the requirement for the study. In addition to the other
information specified in the preceding paragraph, at a minimum, a brief description of current
activity on and the status of the study must be included as well as a full
description of any problems encountered since the last progress report.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports or
protocols. The noted deadlines run from the date of the receipt of this Notice by the registrant.
If the data are not submitted by the deadline, each registrant is subject to receipt of a Notice of
Intent to Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your request, the
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the cost of producing the required data
but will not be submitting the data yourself, you must provide the name of the registrant who
will be submitting the data. You must also provide EPA with documentary evidence that an
agreement has been formed. Such evidence may be your letter offering to join in an
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agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful, you
may request EPA (by selecting this option) to exercise its discretion not to suspend your
registration(s), although you do not comply with the data submission requirements of this
Notice. EPA has determined that as a general policy, absent other relevant considerations, it
will not suspend the registration of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but the other
registrant(s) developing the data has refused to accept the offer. To qualify for this option,
you must submit documentation to the Agency proving that you have made an offer to
another registrant (who has an obligation to submit data) to share in the burden of developing
that data. You must also submit to the Agency a completed EPA Form 8570-32, Certification
of Offer to Cost Share in the Development of Data, Attachment 7. In addition, you must
demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost-sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition
to anything else, offer to share in the burden of producing the data upon terms to be agreed to
or, failing agreement, to be bound by binding arbitration as provided by FIFRA section
3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA of its
election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer to
share in the burden of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant
fails to develop the data or for some other reason is subject to suspension, your registration as
well as that of the other registrant normally will be subject to initiation of suspension
proceedings, unless you commit to submit, and do submit, the required data in the specified
time frame. In such cases, the Agency generally will not grant a time extension for submitting
the data.
Option 4. Submitting an Existing Study
If you choose to submit an existing study in response to this Notice, you must determine
that the study satisfies the requirements imposed by this Notice. You may only submit a study
that has not been previously submitted to the Agency or previously cited by anyone. Existing
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studies are studies which predate issuance of this Notice. Do not use this option if you are
submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly Met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with the requirements of
the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in 40 CFR
160.3 'Raw data1 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
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completed prior to January 1970 rarely satisfied the purpose of the PAG and that
necessary raw data usually are not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of the
criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting, you must identify
any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed
in the final protocol and study.
If you know of a study pertaining to any requirement in this Notice which does not meet the
criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
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 MRJDD 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.
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Option 6. Citing Existing Studies
If you choose to cite a study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable, or it must be a study which has not yet
been reviewed by the Agency. Acceptable toxicology studies generally will have been
classified as "core-guideline" or "core-minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all other disciplines the classification
would be "acceptable." With respect to any studies for which you wish to select this option,
you must provide the MRID number of the study you are citing and, if the study has been
reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must submit a
completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
2. Product Specific Data
If you acknowledge on the product specific Data Call-in Response Form that you agree to
satisfy the product specific data requirements (i.e. you select option 7a or 7b), then you must
select one of the six options on the Requirements Status and Registrant's Response Form
related to data production for each data requirement. Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production are
the first six 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 III.C.l, Option 1) except that normally
no protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data -- If you enter into an agreement to cost
share, the same requirements apply to product specific data as to generic data (see Section
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III.C.l, Option 2). However, registrants may only choose this option for acute toxicity data
and certain efficacy data and only if EPA has indicated in the attached data tables that your .
product and at least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which data will be submitted must be noted
in the agreement to cost share by the registrant selecting this option.
Option 3. Offer to Share in the Cost of Data Development —The same requirements for
generic data (Section in.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.
Option 4. Submitting an Existing Study ~ The same requirements described for generic data
(see Section m.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 in.C.I., Option 5) apply to this option for product specific data.
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section ni.C.l., Option 6) apply to this option for product specific data.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (III.C.l.), as appropriate.
m-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
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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 produces), as part of your 90-day response to this Notice:
(i). Total company sales (pounds and dollars) of all registered product(s) containing
the active ingredient. If applicable to the active ingredient, include foreign sales for those
products that are not registered in this country but are applied to sugar (cane or beet),
coffee, bananas, cocoa, and other such crops. Present the above information by year for
each of the past five years.
(ii) Provide an estimate of the sales (pounds and dollars) of the active ingredient for
each major use site. Present the above information by year for each of the past five years.
(iii) Total direct production cost of product(s) containing the active ingredient by year
for the past five years. Include information on raw material cost, direct labor cost,
advertising, sales and marketing, and any other significant costs listed separately.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product(s) containing the active ingredient by year for the past five
years. Exclude all non-recurring costs that were directly related to the active ingredient,
such as costs of initial registration and any data development.
(v) A list of each data requirement for which you seek a waiver. Indicate the type of
waiver sought and the estimated cost to you (listed separately for each data requirement and
associated test) of conducting the testing needed to fulfill each of these data requirements.
(vi) A list of each data requirement for which you are not seeking any waiver and the
estimated cost to you (listed separately for each data requirement and associated test) of
conducting the testing needed to fulfill each of these data requirements.
(vii) For each of the next ten years, a year-by-year forecast of company sales (pounds
and dollars) of the active ingredient, direct production costs of product(s) containing the
active ingredient (following the parameters in item 2 above), indirect production costs of
product(s) containing the active ingredient (following the parameters in item 3 above), and
costs of data development pertaining to the active ingredient.
(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
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unique to the active ingredient, providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then present the
reasoning used to derive your estimates. To assist the Agency in determining the degree of
importance of the active ingredient in terms of its benefits, you should provide information
on any of the following factors, as applicable to your product(s): (a) documentation of the
usefulness of the active ingredient in Integrated Pest Management, (b) description of the
beneficial impacts on the environment of use of the active ingredient, as opposed to its
registered alternatives, (c) information on the breakdown of the active ingredient after use
and on its persistence in the environment, and (d) description of its usefulness against a
pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the request
for a waiver.
b. Request for Waiver of Data
Option 9, under Item 9, on the Requirements Status and Registrant's Response Form.
This option may be used if you believe that a particular data requirement should not apply
because the requirement is inappropriate. You must submit a rationale explaining why you
believe the data requirements should not apply. You also must submit the current label(s) of
your product(s) and, if a current copy of your Confidential Statement of Formula is not
already on file you must submit a current copy.
You will be informed of the Agency's decision in writing. If the Agency determines
that the data requirements of this Notice are not appropriate to your product(s), you will not
be required to supply the data pursuant to section 3(c)(2)(B). If EPA determines that the
data are required for your productfsl 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
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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.
SECTION IV.
CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies, as
required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure of
a registrant on whom you rely for a generic data exemption either to:
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i. Inform EPA of intent to, develop and submit the data required by this Notice on a
Data Call-in Response Form and a Requirements Status and Registrant's Response
Form.
ii. Fulfill the commitment to develop and submit the data as required by this Notice;
or
iii. Otherwise take appropriate steps to meet the requirements stated in this Notice,
unless you commit to submit and do submit the required data in the specified time
frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
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.
i
3) EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or contained
in PR 86-5. All studies must be submitted in the form of a final report; a preliminary report
will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent
with the purposes of the Act.
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The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding generally would
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances. If you believe such disposition of existing stocks of your
product(s) which may be suspended for failure to comply with this Notice should be
permitted, you have the burden of clearly demonstrating to EPA that granting such permission
would be consistent with the Act. You also must explain why an "existing stocks" provision is
necessary, including a statement of the quantity of existing stocks and your estimate of the
time required for their sale, distribution, and use. Unless you meet this burden, the Agency
will not consider any request pertaining to the continued sale, distribution, or use of your
existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due, unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3-year study is scheduled to be submitted, all progress
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 thatFIFRA 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
185
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If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status
Sheet.
All responses to this Notice must include completed Data Call-in Response Forms
(Attachment 2)and completed Requirements Status and Registrant's Response Forms
(Attachment 3), for both (generic and product specific data) and any other documents
required by this Notice, and should be submitted to the contact person(s) identified in
Attachment 1. If the voluntary cancellation or. generic data exemption option is chosen, only
the Generic and Product Specific Data Call-In Response Forms need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance
(OECA), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois Rossi, Division 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 - EPA Acceptance Criteria
6- List of Registrants Receiving This Notice
7- Confidential Statement of Formula. Cost Share and Data Compensation Forms
186
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TRIFLURALIN DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing trifluralin.
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
trifluralin. 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 trifluralin 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 trifluralin are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency
has concluded that additional data on trifluralin 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 trifluralin products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of trifluralin, please contact
Connie Childress at (703) 308-8076.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Franklin Gee at (703) 308-8008.
(703) 308-8172.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Trifluralin
187
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trifluralin DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing trifluralin.
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 trifluralin. 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 trifluralin Generic Data Callln (Attachment F).
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for trifluralin are
contained in the Requirements Status and Registrant's Response. Attachment C. The Agency
has concluded that additional product-chemistry data on trifluralin are needed. These data are
needed to fully complete the reregistration of all eligible trifluralin products.
INQUIRIES
| RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Connie Childress at (703) 308-8076.
All responses to this Notice for the generic data requirements should be submitted to:
Connie Childress, Chemical Review Manager
Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Trifluralin
188
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Instructions For Completing The "Data Call-In Response Forms" For The Generic And
Product Specific Data Call-in
INTRODUCTION
These instructions apply, to the Generic and Product Specific "Data Call-in Response Forms"
and are to be used by registrants to respond to generic and product specific Data Call-Ins as
part of EPA's Reregistration Program under the Federal Insecticide, Fungicide, and
Rodenticide Act. 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 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. "
189
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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.
ItemS. 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
190
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
incorporate that product into all your products, you may complete this item for all
products listed on this form. If, however, you produce the active ingredient yourself, or
use any unregistered product (regardless of the fact that some of your sources are
registered), you may not claim a Generic Data Exemption and you may not select this
item.
Item 6b. ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is
for generic data as indicated in Item 3 and if you are agreeing to satisfy the
generic data requirements of this Data Call-In. Attach the Requirements Status
and Registrant's Response Form that indicates how you will satisfy those
requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
Item la. ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing
use product (MUP) for which you wish to maintain registration, you must agree
to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration,
you must agree to satisfy the data requirements by responding "yes."
FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if your
product is identical to another product and you qualify for a data exemption. You
must provide the EPA registration numbers of your source(s); do not complete the
Requirements Status and Registrant's Response form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
If you are requesting a data waiver, answer "yes" here; in addition, on the
"Requirements Status and Registrant's Response" form under Item 9, you must
respond with option 7 (Waiver Request) for each study for which you are requesting a
waiver.
NOTE: Item 7a and 7b are not applicable for Generic Data.
191
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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.
Notcl You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you may
wfeh to report that your producthas 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
192
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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 cr 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.
193
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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.
ItemS. ON THE GENERIC DATA FORM: This item identifies the type of Data
Call-In. The date of issuance is date stamped.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the type of
Data Call-in. The date of issuance is also date stamped. Note the unique identifier
number (ID#) assigned by the Agency. This ID number must be used in the
transmittal document for any data submissions in response to this Data Call-In Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline reference number of
studies required. These guidelines, in addition to the requirements specified in
the Data Call-Li 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 m 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.
194
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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
Item 7. ON BOTH FORMS: This item identifies the code assigned to the substance
that must be used for testing. A brief description of each code follows:
EUP
MP
MP/TGAI
PAI
PAI/M
PAI/PAffiA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TEP/MET
TEP/PALM
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
195
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TGAI
TGAI/PAI
TGAI/PAIRA
TGAI/TEP
MET
IMP
DEGR
*
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active Ingredient
Technical Grade Active Ingredient or Pure Active Ingredient
Radiolabelled
Technical Grade Active Ingredient or Typical End-Use Product
Metabolites
Impurities
Degradates
See: guideline comment
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, I understand that this option is
available for acute toxicity or certain efficacy data ONLY if the Agency
indicates in an attachment to this notice that my product is similar enough to
another product to qualify for this option. I certify that another party in the
196
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agreement is committing to submit or provide the required data; if the required
study is not submitted on time, my product may be subject to suspension.
Option 3. ON BOTH FORMS: fOffer to Cost Shared 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 Studv^ 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 Studv^ 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
197
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may also choose this option if I am citing my own data. In either case, I will
provide the MBJQD or Accession number (s). If I cite another registrant's data, I
will submit a completed "Certification With Respect To Data Compensation
Requirements" form.
FOR THE GENERIC DATA FORM ONLY; The following three options (Numbers 7,
8, and 9) are responses that apply only to the "Requirements Status and Registrant's
Response Form" for generic data.
Option 7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
Option 8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In Notice and I
request a low-volume minor use waiver of the data requirement. I am attaching
a detailed justification to support this waiver request including, among other
things, all information required to support the request. I understand that, unless
modified by the Agency in writing, the data requirement as stated in the Notice
governs.
Option 9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than 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 my current labels. (You must also submit a copy of your
Confidential Statement of Formula if not already on file with EPA). I
understand that, unless modified by the Agency in writing, the data requirement
as stated in the Notice governs.
FOR PRODUCT SPECIFIC DATA: The following option (number 7) is a response
that applies to the "Requirements Status and Registrant's Response Form" for
product specific data.
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 FIFRA. If the Agency denies
my waiver request, I must choose a method of meeting the data requirements of
this Notice by the due date stated by this Notice. In this case, I must, within 30
days-of my receipt of the Agency's written decision, submit a revised
"Requirements Status" form specifying the option chosen. I also understand
198
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that the deadline for submission of data as specified by the original Data
Call-In notice will not change.
Item 10. ON BOTH FORMS: This item must be signed by an authorized representative
of your company. The person signing must include his/her title, and must initial
and date aill other pages of this form.
Item 11. ON BOTH FORMS: Enter the date of signature.
Item 12. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 13. ON BOTH FORMS: Enter the phone number of your company contact.
NOTE: You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example, you
may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
199
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EPA'S BATCHING OF PRODUCTS CONTAINING TRIFLURALIN AS THE
ACTIVE INGREDIENT FOR MEETING ACUTE TOXICITY DATA
REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing the active ingredient
trifluralin (a,a,a-trifluoro-2,6-dinitro-N,N-dipropyl-p-toluidine) the Agency has batched
products which can be considered similar in terms of acute toxicity. Factors considered in the
sorting process include each product's active and inert ingredients (identity, percent
composition and biological activity), type of formulation (e.g., emulsifiable concentrate,
aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use classification,
precautionary labeling, etc.). Note that the Agency is not describing batched products as
"substantially similar" since some products within a batch may not be considered chemically
similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right
to require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products'within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see
acceptance criteria attached), the formulation tested is considered by EPA to be similar for
acute toxicity, and the formulation has not been significantly altered since submission and
acceptance of the acute toxicity data. Regardless of whether new data is generated or
existing data is referenced, registrants must clearly identify the test material by EPA
Registration Number. If more than one confidential statement of formula (CSF) exists for a
product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the
registrant will meet the data requirements for each product. The second form, "Requirements
Status and Registrant's Response," lists the product specific data required for each product,
including the standard six acute toxicity tests. A registrant who wishes to participate in a
batch must decide whether he/she will provide the data or depend on someone else to do so.
If a registrant supplies the data to support a batch of products, he/she must select one of the
201
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following options: Developing Data (Option 1), Submitting an Existing Study (Option 4),
Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a
registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2),
Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does
not want to participate in a batch, the choices are Options 1,4, 5 or 6. However, a registrant
should know that choosing not to participate in a batch does not preclude other registrants in
the batch from citing his/her studies and offering to cost share (Option 3) those studies.
Table 1 displays the batches for the active ingredient trifluralin.
Table 1.
Batch
1
Registration
Number
19713-226
33660-3
42750-30
62719-99
67959-1
68153-3
Percent Active Ingredient
Trifluralin ... 96.0%
Trifluralin ... 96.0%
Trifluralin ... 95.6%
Trifluralin ... 96.3%
Trifluralin ... 97.47%
Trifluralin ... 96.3%
Form
powder
powder
powder
powder
powder
powder
2
1812-321
62719-216
Trifluralin ... 80.0%
Trifluralin ... 80.0%
powder
powder
3
241-334
241-343 ,
1386-609
1812-355
2749-513
5481-172
5905-519
Trifluralin ... 46.0%
Trifluralin ... 42.8%
Trifluralin ... 44.5%
Trifluralin ... 42.8%
Trifluralin ... 44.5%
Trifluralin ... 44.5%
Trifluralin ... 44.5%
liquid
liquid
liquid
liquid
liquid
liquid
liquid
202
-------
Batch
Registration
Number
9779-303
10163-101
10163-181
33660-33
34704-241
34704-242
36480-33
46193-6
46193-10
51036-106
55467-2
62719-93
62719-97
62719-101
62719-241
Percent Active Ingredient
Trifluralin ... 46.0%
Trifluralin ... 44.5%
Trifluralin ... 44.5%
Trifluralin ... 44.5%
Trifluralin ... 44.5%
Trifluralin ... 44.5%
Trifluralin ... 44.5%
Trifluralin ... 44.5%
Trifluralin ... 42.8%
Trifluralin ... 44.5%
Trifluralin ... 44.5%
Trifluralin... 44. 5%
Trifluralin ...44.5%
Trifluralin ... 44.5%
Trifluralin ... 44.5%
Form
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
4
241-332
241-333
1812-353
2749-514
9779-304
10163-99
33660-31
Trifluralin... 50.8%
Trifluralin... 41.2%
Trifluralin ... 50.8%
Trifluralin... 41.2%
Trifluralin ... 41.2%
Trifluralin ... 50.8%
Trifluralin ... 50.8%
liquid
liquid
liquid
liquid
liquid
liquid
liquid
203
-------
Batch
Registration
Number
33660-32
34704-709
34704-711
51036-126
62719-116
62719-118
62719-172
66222-13
Percent Active Ingredient
Trifluralin ... 41.2%
Trifluralin ... 50.8%
Trifluralin... 41.2%
Trifluralin... 41.2%
Trifluralin ...4 1.2%
Trifluralin ... 50.8%
Trifluralin ... 50.8%
Trilfuralin ... 41,8%
Form
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
5
1386-623
10163-120
34704-708
62719-131
Trifluralin ... 10.0%
Trifluralin ... 10.0%
Trifluralin ... 10.0%
Trifluralin ... 10.0%
granular
granular
granular
granular
6
279-3104
62719-143
Trifluralin... 33.3%
2-(2-Chlorophenyl)methyl-4,4-
dimethyl-3-isoxazolidinone ... 26.7
Trifluralin ...33. 2%
2-(2-Chlorophenyl)methyl-4,4-
dimethyl-3-isoxazolidinone ... 24.9%
liquid
liquid
7
572-324
572-325
10370-254
Trifluralin ... 0.38%
Benefm ... 0.77%
Trifluralin ... 0.38%
Benefm ... 0.77%
Trifluralin... 0.31%
Benefm ... 0.61%
granular
granular
granular
204
-------
Batch
Registration
Number
34704-266
62719-137
Percent Active Ingredient
Trifluralin ... 0.38%
Benefm ... 0.77%
Trifluralin ... 0.67%
Benefm ... 1.33%
Form
granular
granular
8
270-281
538-102
557-2001
572-200
961-280
961-335
961-405
2217-480
7401-349
8378-41
9198-60
9198-129
49585-25
62719-98
Trifluralin ... 1.75%
Trifluralin... 2.65%
Trifluralin... 1.15%
Trifluralin ... 1.15%
Trifluralin ... 1.47%
Trifluralin... 1.75%
Trifluralin ... 5.00%
Trifluralin... 1.47%
Trifluralin... 1.47%
Trifluralin ... 1.47%
Trifluralin... 1.47%
Trifluralin ... 5.00%
Trifluralin... 1.75%
Trifluralin ... 5.00%
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
9
9198-98
9198-99
Trifluralin... 0.38%
Benefm ... 0.77%
Chloropyrifos ... 0.57%
Trifluralin... 0.19%
Benefm ... 0.38%
Chloropyrifos ... 0.57%
granular
granular
205
-------
Batch
Registration
Number
9198-102
Percent Active Ingredient
Trifluralin ... 0.28%
Benefin ... 0.59%
Chloropyrifos ... 0.58%
Form
granular
10
8660-144
8660-145
9198-77
Trifluralin ... 14.00%
Benefin ... 14.00%
Trifluralin ... 10.89%
Benefin ... 21.78%
Trifluralin ... 10.89%
Benefin ... 21.78%
powder
powder
powder
11
9779-308
46193-13
Trifluralin ... 60.00%
Trifluralin ... 60.00%
granular
granular
12
59823-1
59823-3
Trifluralin ... 18.9%
Trilfuralin ... 18.9%
powder
powder
Table 2 lists the products the Agency was unable to batch. These products were not batched
because they were not considered to be similar to other products in terms of acute toxicity, or,
the Agency lacked sufficient information about their chemical formulations. Registrants of
this product are responsible for meeting the acute toxicity data requirements for this product.
Table 2.
Registration Number
228-259
241-307
Percent Active Ingredient
Trifluralin ... 3.33%
Benefin ... 6.67%
Trifluralin 28.6%
Ammonium salt of
imazaquin ...4.72%
Form
dust
liquid
206
-------
Registration Number
241-325
524-375
524-422
1812-325
2935-446
3125-375
5905-521
9198-78
62719-128
62719-175
62719-222
Percent Active Ingredient
Trifluralin ... 27.5%
Ammonium salt of
imazethapyr ... 2.2%
Trifluralin ... 3.0%
S (2,3,3-trichloroallyl)
diisopropyl thiocarbamate
... 10.0%
Trifluralin ... 3.9%
Alachlor ... 31.7%
Trifluralin ... 43.8%
Trifluralin ... 0.17%
Disulfoton ... 1.00%
Trifluralin ... 28%
Metribuzin ... 14%
Trifluralin ... 60.0%
Trifluralin ... 14.0%
Benefm ... 14.0%
Trifluralin ... 4%
Tebuthiuron ... 2%
Trifluralin ...2.0%
Isoxaben ... 0.5%
Trifluralin ... 36.35%
Flumetsulam ... 2.67%
Form
liquid
granular
liquid
liquid
granular
liquid
liquid
liquid
granular
granular
liquid
Table 3 displays a group of products that were not batchable, but were not placed into the
"No Batch" group of products. Each of these products contains significant amounts of
fertilizer. Many of these fertilizer components may change from time-to-time as the registrant
sees fit. as much as 99% of these products' formulations may vary, PRS does not feel that it is
possible to batch them. PRS is also concerned that since the formulation of these products
may vary, a set of acute toxicity studies conducted on one of these products may not be
consistently representative of that product's acute toxicity potential. Registrant of products is
batch #3 that certify that they do not vary the inert composition of their product(s) may
207
-------
request that their products be batched with other, similar, products. PRS does not believe that
requesting acute toxicity data on all possible fertilizer combinations is sensible. The Agency
has yet to develop a policy to address the labeling for these products..
Tables.
Registration Number
228-208
228-254
228-255
228-256
228-257
228-258
538-83
557-2013
961-283
961-346
961-348
6133-13
8378-17
8378-18
Percent Active Ingredient
Trifluralin ... 0.38%
Benefm ... 0.77%
Trifluralin '.'.. 0.29%
Benefm ... 0.59%
Trifluralin ... 0.37%
Benefm ... 0.74%
Trifluralin ... 0.44%
Benefm ... 0.89%
Trifluralin ... 0.22%
Benefm ... 0.45%
Trifluralin ... 0.75%
Benefm ... 0.75%
Trifluralin ... 0.68%
Trifluralin ... 0.38%
Benefm ... 0.77%
Trifluralin ... 0.74%
Trifluralin ... 0.385%
Benefm ... 0.770%
Trifluralin ... 0.515%
Benefm ... 1.030%
Trifluralin ... 0.385%
Benefm ... 0.765%
Trifluralin ... 0.38%
Benefm ... 0.76%
Trifluralin ... 0.43%
Benefm ... 0.84%
Form
granular
granular
dust
dust
dust
dust
granular
granular
granular
granular
granular
granular
granular
granular
208
-------
Registration Number
8378-19
8378-20
8378-37
8590-667
8660-19
8660-143
8660-149
8660-151
9198-79
9198-91
9198-94
9198-101
9198-108
9198-130
9198-131
Percent Active Ingredient
Trifluralin ... 0.50%
Benefin ... 1.00%
Trifluralin ... 0.30%
Benefin ... 0.62%
Trifluralin ... 0.49%
Benefin ... 0.93%
Trifluralin ... 0.33%
Benefin ... 0.67%
Trifluralin ... 0.43%
Benefin ... 0.85%
Trifluralin ... 0.45%
Benefin ... 0.90%
Trifluralin ... 0.45%
Benefin ... 0.90%
Trifluralin ... 0.38%
Benefin ... 0.76%
Trifluralin ... 0.38%
Benefin ... 0.76%
Trifluralin ... 0.19%
.Benefin ... 0.38%
Trifluralin ... 0.30%
Benefin ... 0.62%
Trifluralin ... 0.28%
Benefin ... 0.59%
Trifluralin ... 0.33%
Benefin ... 0.67%
Trifluralin ... 0.50%
Benefin ... 1.00%
Trifluralin ... 0.515%
Benefin ... 1.030%
Form
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
209
-------
Registration Number
10404-53
10404-56
10404-57
32802-24
32802-33
32802-35
32802-40
43854-1
44561-7
44561-8
44561-9
52200-4
62719-150
62719-151
62719-152
Percent Active Ingredient
Trifluralin ... 0.33%
Benefm ... 0.67%
Trifluralin ... 0.38%
Benefm ... 0.77%
Trifluralin ... 0.41%
Benefm ... 0.84%
Trifluralin ... 0.38%
Benefm ... 0.77%
Trifluralin ... 0.50%
Benefm ... 1.00%
Trifluralin ... 0.29%
Benefm ... 0.58%
Trifluralin ... 0.20%
Benefm ... 0.38%
Trifluralin ... 0.38%
Benefm ... 0.77%
Trifluralin ... 0.306%
Benefm ... 0.613%
Trifluralin ... 0.383%
Benefm ... 0.766%
Trifluralin ... 0.459%
Benefm ... 0.919%
Trifluralin ... 0.29%
Benefm ... 0.58%
Trifluralin ... 0.39%
Benefm ... 0.76%
Trifluralin ... 0.31%
Benefm ... 0.61%
Trifluralin ... 0.43%
Benefm ... 0.82%
Form
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
210
-------
The following is a list of available documents related to trifluralin. It's purpose is to provide
a path to more detailed information if it is needed. These accompanying documents are part
of the Administrative Record for trifluralin and are included in the EPA's Office of Pesticide
Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. trifluralin RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient Statement
211
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible,
signed copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product specific data submission must also
be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds
per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered
source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported
under column 10 and must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In
no case will volumes be accepted. Do not mix English and metric system units (i.e.,
pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure
active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow the
40 CFR 158.175 instructions. An explanation must be provided if the proposed limits
are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs become
obsolete for that specific formulation.
215
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P/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approve! Expire* 3-31-%
Public reporting burden for this collection of information is estimated to average 15 minutes per response, Including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223. U.S. Environmental Protection Agency, 401 M St., S.W.. Washington, DC 20460; and to the Office
of Management and Budget,, Paperwork Reduction Project (2070-0106). Washington, DC 20503.
Please-fill In blanks below.
Company Name
Product Nume
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Flrm(*)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company'* Authorized Representative
Date
Nam* and Title (Please Type or Print)
EPA Form 857(1-32 (5/91) Replaces EPA Form 8580, which is obsolete
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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
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-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
Product Name
Company Number
EPA Reg. No.
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 original
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.
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)
PA Form 8570-31 (4-96)
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